Chapter   2100  Patentability
---SECTION---2105 Patentable Subject Matter - Living Subject Matter

The decision of the Supreme Court in Diamond v. Chakrabarty, 447 U.S.
303, 206 USPQ 193 (1980), held that microorganisms produced by genetic
engineering are not excluded from patent protection by  35 U.S.C. 101.
It is clear from the Supreme Court decision and opinion that the
question of whether or not an invention embraces living matter is
irrelevant to the issue of patentability. The test set down by the Court
for patentable subject matter in this area is whether the living matter
is the result of human intervention.

In view of this decision, the Office has issued these guidelines as to
how  35 U.S.C. 101 will be interpreted.

The Supreme Court made the following points in the Chakrabarty opinion:

1. "Guided by these canons of construction, this Court has read the term
`manufacture' in Section  101 in accordance with its dictionary
definition to mean `the production of articles for use from raw
materials prepared by giving to these materials new forms, qualities,
properties, or combinations whether by hand labor or by machinery.'"

   2. "In choosing such expansive terms as "manufacture" and
"composition of matter," modified by the comprehensive "any," Congress
plainly contemplated that the patent laws would be given wide scope."

   3. "The Act embodied Jefferson's philosophy that "ingenuity should
receive a liberal encouragement." 5 Writings of Thomas Jefferson, at
75-76. See Graham v. John Deere Co., 383 U.S. 1, 7-10 (1966). Subsequent
patent statutes in 1836, 1870, and 1874 employed this same broad
language. In 1952, when the patent laws were recodified, Congress
replaced the word "art" with "process," but otherwise left Jefferson's
language intact. The Committee Reports accompanying the 1952 act inform
us that Congress intended statutory subject matter to "include any thing
under the sun that is made by man." S. Rep. No. 1979, 82d Cong., 2d
Sess., 5 (1952)."

   4. "This is not to suggest that Section  101 has no limits or that it
embraces every discovery. The laws of nature, physical phenomena, and
abstract ideas have been held not patentable."

   5. "Thus, a new mineral discovered in the earth or a new plant found
in the wild is not patentable subject matter. Likewise, Einstein could
not patent his celebrated law that E=mc2 ; nor could Newton have
patented the law of gravity."

   6. "His claim is not to a hitherto unknown natural phenomenon, but to
a nonnaturally occurring manufacture or composition of matter __ a
product of human ingenuity "having a distinctive name, character [and]
use.""

   7. "Congress thus recognized that the relevant distinction was not
between living and inanimate things, but between products of nature,
whether living or not, and human-made inventions. Here, respondent's
microorganism is the result of human ingenuity and research."

   8. After reference to Funk Seed Co. & Kalo Co., 333 U.S.127 (1948),
"Here, by contrast, the patentee has produced a new bacterium with
markedly different characteristics from any found in nature and one
having the potential for significant utility. His discovery is not
nature's handiwork, but his own; accordingly it is patentable subject
matter under Section  101."

A review of the Court statements above as well as the whole Chakrabarty
opinion reveals:

(A) That the Court did not limit its decision to genetically engineered
living organisms;

(B) The Court enunciated a very broad interpretation of "manufacture"
and "composition of matter" in  35 U.S.C. 101 (Note esp. quotes 1, 2,
and 3 above);

(C) The Court set forth several tests for weighing whether patentable
subject matter under  35 U.S.C. 101 is present stating (in quote 7
above) that:

The relevant distinction was not between living and inanimate things but
between products of nature, whether living or not, and human-made
inventions.

The tests set forth by the Court are (note especially the italicized
portions):

(A) "The laws of nature, physical phenomena and abstract ideas" are not
patentable subject matter.

(B) A "nonnaturally occurring manufacture or composition of matter - a
product of human ingenuity -having a distinctive name, character, [and]
use" is patentable subject matter.

(C) "[A] new mineral discovered in the earth or a new plant found in the
wild is not patentable subject matter. Likewise, Einstein could not
patent his celebrated E=mc2; nor could Newton have patented the law of
gravity. Such discoveries are "manifestations of . . . nature, free to
all men and reserved exclusively to none." ''

(D) "[T]he production of articles for use from raw materials prepared by
giving to these materials new forms, qualities, properties, or
combinations whether by hand labor or by machinery" [emphasis added] is
a "manufacture" under  35 U.S.C. 101.

In analyzing the history of the Plant Patent Act of 1930, the Court
stated: "In enacting the Plant Patent Act, Congress addressed both of
these concerns [the concern that plants, even those artificially bred,
were products of nature for purposes of the patent law and the concern
that plants were thought not amenable to the written description]. It
explained at length its belief that the work of the plant breeder `in
aid of nature' was patentable invention. S. Rep. No. 315, 71st Cong., 2d
Sess., 6-8 (1930); H.R. Rep. No. 1129, 71st Cong., 2d Sess., 7-9
(1930)."

The Office will decide the questions as to patentable subject matter
under  35 U.S.C. 101 on a case-by-case basis following the tests set
forth in Chakrabarty, e.g., that "a nonnaturally occurring manufacture
or composition of matter" is patentable, etc. It is inappropriate to try
to attempt to set forth here in advance the exact parameters to be
followed.

The standard of patentability has not and will not be lowered. The
requirements of  35 U.S.C. 102 and 103 still apply. The tests outlined
above simply mean that a rational basis will be present for any  35
U.S.C. 101 determination. In addition, the requirements of  35 U.S.C.
112 must also be met. In this regard, see MPEP Section  608.01(p).

Following this analysis by the Supreme Court of the scope of  35 U.S.C.
101, the Board of Patent Appeals and Interferences has determined that
plant subject matter or an animal may be protected under  35 U.S.C. 101.
In Ex parte Hibberd, 227 USPQ 443 (Bd. Pat. App. & Inter. 1985) the
Board held that plant subject matter may be the proper subject of a
patent under  35 U.S.C. 101 even though such subject matter may be
protected under the Plant Patent Act (35 U.S.C. 161 - 164) or the Plant
Variety Protection Act (7 U.S.C. 2321 et seq.). In Ex parte Allen, 2
USPQ2d 1425 (Bd. Pat. App. & Inter. 1987), the Board decided that a
polyploid Pacific coast oyster could have been the proper subject of a
patent under  35 U.S.C. 101 if all the criteria for patentability were
satisfied. Shortly after the Allen decision, the Commissioner of Patents
and Trademarks issued a notice (Animals - Patentability, 1077 O.G. 24,
April 21, 1987) that the Patent and Trademark Office would now consider
nonnaturally occurring, nonhuman multicellular living organisms,
including animals, to be patentable subject matter within the scope of 
35 U.S.C. 101.

If the broadest reasonable interpretation of the claimed invention as a
whole encompasses a human being, then a rejection under  35 U.S.C. 101
must be made indicating that the claimed invention is directed to
nonstatutory subject matter. Furthermore, the claimed invention must be
examined with regard to all issues pertinent to patentability, and any
applicable rejections under  35 U.S.C. 102, 103, or 112 must also be
made.

---SECTION---2106 Patentable Subject Matter - Computer-Related
Inventions

I. INTRODUCTION

These Examination Guidelines for Computer-Related Inventions
("Guidelines") are to assist Office personnel in the examination of
applications drawn to computer-related inventions. "Computer-related
inventions" include inventions implemented in a computer and inventions
employing computer-readable media.  The Guidelines are based on the
Office's current understanding of the law and are believed to be fully
consistent with binding precedent of the Supreme Court, the Federal
Circuit and the Federal Circuit's predecessor courts.

These Guidelines do not constitute substantive rulemaking and hence do
not have the force and effect of law.  These Guidelines have been
designed to assist Office personnel in analyzing claimed subject matter
for compliance with substantive law. Rejections will be based upon the
substantive law and it is these rejections which are appealable.
Consequently, any failure by Office personnel to follow the Guidelines
is neither appealable nor petitionable.

The Guidelines alter the procedures Office personnel will follow when
examining applications drawn to computer-related inventions and are
equally applicable to claimed inventions implemented in either hardware
or software. The Guidelines also clarify the Office's position on
certain patentability standards related to this field of technology.
Office personnel are to rely on these Guidelines in the event of any
inconsistent treatment of issues between these Guidelines and any
earlier provided guidance from the Office.

	The Freeman-Walter-Abele test (In re Abele, 684 F.2d 902, 905-07, 214
USPQ 682, 685-87 (CCPA 1982); In re Walter, 618 F.2d 758, 767, 205 USPQ
397, 406-07 (CCPA 1980); In re Freeman, 573 F.2d 1237, 1245, 197 USPQ
464, 471 (CCPA 1978)) may additionally be relied upon in analyzing
claims directed solely to a process for solving a mathematical
algorithm.

Office personnel have had difficulty in properly treating claims
directed to methods of doing business.  Claims should not be categorized
as methods of doing business.  Instead, such claims should be treated
like any other process claims, pursuant to these Guidelines when
relevant.  See, e.g., In re Toma, 575 F.2d 872, 877-78, 197 USPQ 852,
857 (CCPA 1978); In re Musgrave, 431 F.2d 882, 893, 167 USPQ 280, 289-90
(CCPA 1970).  See also In re Schrader, 22 F.3d 290, 297-98, 30 USPQ2d
1455, 1461-62 (Fed. Cir. 1994) (Newman, J., dissenting); Paine, Webber,
Jackson & Curtis, Inc. v. Merrill Lynch, Pierce, Fenner & Smith, Inc.,
564 F. Supp. 1358, 1368-69, 218 USPQ 212, 220 (D. Del. 1983).

The appendix which appears at the end of this section includes a flow
chart of the process Office personnel will follow in conducting
examinations for computer-related inventions.

II. DETERMINE WHAT APPLICANT HAS INVENTED AND IS SEEKING TO PATENT

It is essential that patent applicants obtain a prompt yet complete
examination of their applications. Under the principles of compact
prosecution, each claim should be reviewed for compliance with every
statutory requirement for patentability in the initial review of the
application, even if one or more claims are found to be deficient with
respect to some statutory requirement. Thus, Office personnel should
state all reasons and bases for rejecting claims in the first Office
action.  Deficiencies should be explained clearly, particularly when
they serve as a basis for a rejection.  Whenever practicable, Office
personnel should indicate how rejections may be overcome and how
problems may be resolved.  A failure to follow this approach can lead to
unnecessary delays in the prosecution of the application.

Prior to focusing on specific statutory requirements, Office personnel
must begin examination by determining what, precisely, the applicant has
invented and is seeking to patent, and how the claims relate to and
define that invention.  (As the courts have repeatedly reminded the
Office:  "The goal is to answer the question " `What did applicants
invent?' " Abele, 684 F.2d at 907, 214 USPQ at 687. Accord, e.g.,
Arrhythmia Research Tech. v. Corazonix Corp., 958 F.2d 1053, 1059, 22
USPQ2d 1033, 1038 (Fed. Cir. 1992).)  Consequently, Office personnel
will no longer begin examination by determining if a claim recites a
"mathematical algorithm."  Rather, they will review the complete
specification, including the detailed description of the invention, any
specific embodiments that have been disclosed, the claims and any
specific utilities that have been asserted for the invention. 

A. Identify and Understand Any Practical Application Asserted for the
Invention

The subject matter sought to be patented must be a "useful" process,
machine, manufacture, or composition of matter; i.e., it must have a
practical application.  The purpose of this requirement is to limit
patent protection to inventions that possess a certain level of "real
world" value, as opposed to subject matter that represents nothing more
than an idea or concept, or is simply a starting point for future
investigation or research (Brenner v. Manson, 383 U.S. 519, 528-36, 148
USPQ 689, 693-96 (1966); In re Ziegler, 992 F.2d 1197, 1200-03, 26
USPQ2d 1600, 1603-06 (Fed. Cir. 1993)).  Accordingly, a complete
disclosure should contain some indication of the practical application
for the claimed invention, i.e., why the applicant believes the claimed
invention is useful.

The utility of an invention must be within the "technological" arts.
See, e.g., Musgrave, 431 F.2d at 893, 167 USPQ at 289-90, cited with
approval in Schrader, 22 F.3d at 297, 30 USPQ2d at 1461 (Newman, J.,
dissenting).  (The definition of "technology" is the "application of
science and engineering to the development of machines and procedures in
order to enhance or improve human conditions, or at least to improve
human efficiency in some respect."  Computer Dictionary 384 (Microsoft
Press, 2d ed. 1994).)  A computer-related invention is within the
technological arts.  A practical application of a computer-related
invention is statutory subject matter. This requirement can be discerned
from the variously phrased prohibitions against the patenting of
abstract ideas, laws of nature or natural phenomena. An invention that
has a practical application in the technological arts satisfies the
utility requirement. See, e.g.,   In re Alappat, 33 F.3d 1526, 1543, 31
USPQ2d 1545, 1556-57 (Fed. Cir. 1994) (in banc) (quoting Diamond v.
Diehr, 450 U.S. 175, 192, 209 USPQ 1, 10 (1981)).  See also Alappat at
1569, 31 USPQ2d at 1578-79 (Newman, J., concurring) ("unpatentability of
the principle does not defeat patentability of its practical
applications") (citing O'Reilly v. Morse, 56 U.S. (15 How.) 62, 114-19
(1854)); Arrhythmia, 958 F.2d at 1056, 22 USPQ2d at 1036; Musgrave, 431
F.2d at 893, 167 USPQ at 289-90 ("All that is necessary, in our view, to
make a sequence of operational steps a statutory "process" within  35
U.S.C. 101 is that it be in the technological arts so as to be in
consonance with the Constitutional purpose to promote the progress of
"useful arts."  Const. Art. 1, sec. 8.").

The applicant is in the best position to explain why an invention is
believed useful.  Office personnel should therefore focus their efforts
on pointing out statements made in the specification that identify all
practical applications for the invention.  Office personnel should rely
on such statements throughout the examination when assessing the
invention for compliance with all statutory criteria.  An applicant may
assert more than one practical application, but only one is necessary to
satisfy the utility requirement.  Office personnel should review the
entire disclosure to determine the features necessary to accomplish at
least one asserted practical application.

B. Review the Detailed Disclosure and Specific Embodiments of the
Invention to Determine What the Applicant Has Invented

The written description will provide the clearest explanation of the
applicant's invention, by exemplifying the invention, explaining how it
relates to the prior art and explaining the relative significance of
various features of the invention. Accordingly, Office personnel should
begin their evaluation of a computer-related invention as follows:

- determine what the programmed computer does when it performs the
processes dictated by the software (i.e., the functionality of the
programmed computer) (Arrhythmia, 958 F.2d at 1057, 22 USPQ at 1036, "It
is of course true that a modern digital computer manipulates data,
usually in binary form, by performing mathematical operations, such as
addition, subtraction, multiplication, division, or bit shifting, on the
data.  But this is only how the computer does what it does.  Of
importance is the significance of the data and their manipulation in the
real world, i.e., what the computer is doing.");

- determine how the computer is to be configured to provide that
functionality (i.e., what elements constitute the programmed computer
and how those elements are configured and interrelated to provide the
specified functionality); and

- if applicable, determine the relationship of the programmed computer
to other subject matter outside the computer that constitutes the
invention (e.g., machines, devices, materials, or process steps other
than those that are part of or performed by the programmed computer).
(Many computer-related inventions do not consist solely of a computer. 
Thus, Office personnel should identify those claimed elements of the
computer-related invention that are not part of the programmed computer,
and determine how those elements relate to the programmed computer. 
Office personnel should look for specific information that explains the
role of the programmed computer in the overall process or machine and
how the programmed computer is to be integrated with the other elements
of the apparatus or used in the process.)

Patent applicants can assist the Office by preparing applications that
clearly set forth these aspects of a computer-related invention.

C. Review the Claims

The claims define the property rights provided by a patent, and thus
require careful scrutiny.  The goal of claim analysis is to identify the
boundaries of the protection sought by the applicant and to understand
how the claims relate to and define what the applicant has indicated is
the invention.  Office personnel must thoroughly analyze the language of
a claim before determining if the claim complies with each statutory
requirement for patentability.

Office personnel should begin claim analysis by identifying and
evaluating each claim limitation. For processes, the claim limitations
will define steps or acts to be performed.  For products, the claim
limitations will define discrete physical structures. Product claims are
claims that are directed to either machines, manufactures or
compositions of matter. The discrete physical structures may be
comprised of hardware or a combination of hardware and software.

Office personnel are to correlate each claim limitation to all portions
of the disclosure that describe the claim limitation. This is to be done
in all cases, i.e., whether or not the claimed invention is defined
using means or step plus function language. The correlation step will
ensure that Office personnel correctly interpret each claim limitation.

The subject matter of a properly construed claim is defined by the terms
that limit its scope.  It is this subject matter that must be examined.
As a general matter, the grammar and intended meaning of terms used in a
claim will dictate whether the language limits the claim scope. 
Language that suggests or makes optional but does not require steps to
be performed or does not limit a claim to a particular structure does
not limit the scope of a claim or claim limitation. The following are
examples of language that may raise a question as to the limiting effect
of the language in a claim:

(A) statements of intended use or field of use,

(B) "adapted to" or  "adapted for" clauses,

(C) "wherein" clauses, or

(D) "whereby" clauses. This list of examples is not intended to be
exhaustive.

Office personnel must rely on the applicant's disclosure to properly
determine the meaning of terms used in the claims. Markman v. Westview
Instruments, 52 F.3d 967, 980, 34 USPQ2d 1321, 1330 (Fed. Cir.) (en
banc), aff'd,  U.S. , 116 S. Ct. 1384 (1996).  An applicant is entitled
to be his or her own lexicographer, and in many instances will provide
an explicit definition for certain terms used in the claims.  Where an
explicit definition is provided by the applicant for a term, that
definition will control interpretation of the term as it is used in the
claim.  Office personnel should determine if the original disclosure
provides a definition consistent with any assertions made by applicant.
See, e.g., In re Paulsen, 30 F.3d 1475, 1480, 31 USPQ2d 1671, 1674 (Fed.
Cir. 1994) (inventor may define specific terms used to describe
invention, but must do so "with reasonable clarity, deliberateness, and
precision" and, if done, must " `set out his uncommon definition in some
manner within the patent disclosure' so as to give one of ordinary skill
in the art notice of the change" in meaning) (quoting Intellicall, Inc.
v. Phonometrics, Inc., 952 F.2d 1384, 1387-88, 21 USPQ2d 1383, 1386
(Fed. Cir. 1992)).  If an applicant does not define a term in the
specification, that term will be given its "common meaning." Paulsen, at
30 F. 3d 1480, 31 USPQ2d at 1674.

If the applicant asserts that a term has a meaning that conflicts with
the term's art-accepted meaning, Office personnel should encourage the
applicant to amend the claim to better reflect what applicant intends to
claim as the invention.  If the application becomes a patent, it becomes
prior art against subsequent applications.  Therefore, it is important
for later search purposes to have the patentee employ commonly accepted
terminology, particularly for searching text-searchable databases.

Office personnel must always remember to use the perspective of one of
ordinary skill in the art.  Claims and disclosures are not to be
evaluated in a vacuum. If elements of an invention are well known in the
art, the applicant does not have to provide a disclosure that describes
those elements. In such a case the elements will be construed as
encompassing any and every art-recognized hardware or combination of
hardware and software technique for implementing the defined requisite
functionalities.

Office personnel are to give claims their broadest reasonable
interpretation in light of the supporting disclosure. See, e.g., In re
Zletz, 893 F.2d 319, 321-22, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989)
("During patent examination the pending claims must be interpreted as
broadly as their terms reasonably allow. . . .  The reason is simply
that during patent prosecution when claims can be amended, ambiguities
should be recognized, scope and breadth of language explored, and
clarification imposed. . . .  An essential purpose of patent examination
is to fashion claims that are precise, clear, correct, and unambiguous. 
Only in this way can uncertainties of claim scope be removed, as much as
possible, during the administrative process.").

Where means plus function language is used to define the characteristics
of a machine or manufacture invention, claim limitations must be
interpreted to read on only the structures or materials disclosed in the
specification and "equivalents thereof." (Two en banc decisions of the
Federal Circuit have made clear that the Office is to interpret means
plus function language according to  35 U.S.C. 112, sixth paragraph.  In
the first, In re Donaldson, 16 F.3d 1189, 1193, 29 USPQ2d 1845, 1848
(Fed. Cir. 1994), the court held:

The plain and unambiguous meaning of paragraph six is that one
construing means-plus-function language in a claim must look to the
specification and interpret that language in light of the corresponding
structure, material, or acts described therein, and equivalents thereof,
to the extent that the specification provides such disclosure. 
Paragraph six does not state or even suggest that the PTO is exempt from
this mandate, and there is no legislative history indicating that
Congress intended that the PTO should be.  Thus, this court must accept
the plain and precise language of paragraph six.

Consistent with Donaldson, in the second decision, In re Alappat, 33
F.3d at 1540, 31 USPQ2d at 1554, the Federal Circuit held:

Given Alappat's disclosure, it was error for the Board majority to
interpret each of the means clauses in claim 15 so broadly as to "read
on any and every means for performing the function" recited, as it said
it was doing, and then to conclude that claim 15 is nothing more than a
process claim wherein each means clause represents a step in that
process.  Contrary to suggestions by the Commissioner, this court's
precedents do not support the Board's view that the particular apparatus
claims at issue in this case may be viewed as nothing more than process
claims.

Disclosure may be express, implicit or inherent.  Thus, at the outset,
Office personnel must attempt to correlate claimed means to elements set
forth in the written description.  The written description includes the
specification and the drawings.  Office personnel are to give the
claimed means plus function limitations their broadest reasonable
interpretation consistent with all corresponding structures or materials
described in the specification and their equivalents.  Further guidance
in interpreting the scope of equivalents is provided in MPEP Section 
2181 through Section  2186.

While it is appropriate to use the specification to determine what
applicant intends a term to mean, a positive limitation from the
specification cannot be read into a claim that does not impose that
limitation.  A broad interpretation of a claim by Office personnel will
reduce the possibility that the claim, when issued, will be interpreted
more broadly than is justified or intended.  An applicant can always
amend a claim during prosecution to better reflect the intended scope of
the claim.

Finally, when evaluating the scope of a claim, every limitation in the
claim must be considered. Office personnel may not dissect a claimed
invention into discrete elements and then evaluate the elements in
isolation.  Instead, the claim as a whole must be considered.  See,
e.g., Diamond v. Diehr, 450 U.S. at 188-89, 209 USPQ at 9 ("In
determining the eligibility of respondents' claimed process for patent
protection under  101, their claims must be considered as a whole.  It
is inappropriate to dissect the claims into old and new elements and
then to ignore the presence of the old elements in the analysis.  This
is particularly true in a process claim because a new combination of
steps in a process may be patentable even though all the constituents of
the combination were well known and in common use before the combination
was made.").

III. CONDUCT A THOROUGH SEARCH OF THE PRIOR ART

Prior to classifying the claimed invention under  35 U.S.C. 101, Office
personnel are expected to conduct a thorough search of the prior art. 
Generally, a thorough search involves reviewing both U.S. and foreign
patents and nonpatent literature. In many cases, the result of such a
search will contribute to Office personnel's understanding of the
invention. Both claimed and unclaimed aspects of the invention described
in the specification should be searched if there is a reasonable
expectation that the unclaimed aspects may be later claimed. A search
must take into account any structure or material described in the
specification and its equivalents which correspond to the claimed means
plus function limitation, in accordance with  35 U.S.C. 112, sixth
paragraph and MPEP Section  2181 through Section  2186.

IV. DETERMINE WHETHER THE CLAIMED INVENTION COMPLIES WITH 35 U.S.C. 101

A. Consider the Breadth of 35 U.S.C. 101 Under Controlling Law

As the Supreme Court has held, Congress chose the expansive language of 
35 U.S.C. 101 so as to include "anything under the sun that is made by
man." Diamond v. Chakrabarty, 447 U.S. 303, 308-09, 206 USPQ 193, 197
(1980).  Accordingly, section 101 of title 35, United States Code,
provides:

Whoever invents or discovers any new and useful process, machine,
manufacture, or composition of matter, or any new and useful improvement
thereof, may obtain a patent therefor, subject to the conditions and
requirements of this title.

In Diamond, 477 U.S. at 308-309, 206 USPQ at 197, the court stated:

In choosing such expansive terms as "manufacture" and "composition of
matter," modified by the comprehensive "any," Congress plainly
contemplated that the patent laws would be given wide scope.  The
relevant legislative history also supports a broad construction.  The
Patent Act of 1793, authored by Thomas Jefferson, defined statutory
subject matter as "any new and useful art, machine, manufacture, or
composition of matter, or any new or useful improvement [thereof]."  Act
of Feb. 21, 1793, ch. 11,  Section  1, 1 Stat. 318.  The Act embodied
Jefferson's philosophy that "ingenuity should receive a liberal
encouragement." V Writings of Thomas Jefferson, at 75-76.  See Graham v. 
John Deere Co., 383 U.S. 1, 7-10 (148 USPQ 459, 462-464) (1966). 
Subsequent patent statutes in 1836, 1870, and 1874 employed this same
broad language.  In 1952, when the patent laws were recodified, Congress
replaced the word "art" with "process," but otherwise left Jefferson's
language intact.  The Committee Reports accompanying the 1952 Act inform
us that Congress intended statutory subject matter to "include anything
under the sun that is made by man."  S. Rep. No. 1979, 82d Cong., 2d
Sess., 5 (1952); H.R. Rep. No. 1923, 82d Cong., 2d Sess., 6 (1952).
[Footnote omitted]

This perspective has been embraced by the Federal Circuit:

The plain and unambiguous meaning of section 101 is that any new and
useful process, machine, manufacture, or composition of matter, or any
new and useful improvement thereof, may be patented if it meets the
requirements for patentability set forth in Title 35, such as those
found in sections 102, 103, and 112.  The use of the expansive term
"any" in section 101 represents Congress's intent not to place any
restrictions on the subject matter for which a patent may be obtained
beyond those specifically recited in section 101 and the other parts of
Title 35. . . .  Thus, it is improper to read into section 101
limitations as to the subject matter that may be patented where the
legislative history does not indicate that Congress clearly intended
such limitations.   Alappat, 33 F.3d at 1542, 31 USPQ2d at 1556.

As cast,  35 U.S.C. 101 defines four categories of inventions that
Congress deemed to be the appropriate subject matter of a patent;
namely, processes, machines, manufactures and compositions of matter. 
The latter three categories define "things" while the first category
defines "actions" (i.e., inventions that consist of a series of steps or
acts to be performed). See  35 U.S.C. 100(b) ("The term "process" means
process, art, or method, and includes a new use of a known process,
machine, manufacture, composition of matter, or material.").

Federal courts have held that  35 U.S.C. 101 does have certain limits. 
First, the phrase "anything under the sun that is made by man" is
limited by the text of  35 U.S.C. 101, meaning that one may only patent
something that is a machine, manufacture, composition of matter or a
process.  See, e.g., Alappat, 33 F.3d at 1542, 31 USPQ2d at 1556; In re
Warmerdam, 33 F.3d 1354, 1358, 31 USPQ2d 1754, 1757 (Fed. Cir. 1994). 
Second,  35 U.S.C. 101 requires that the subject matter sought to be
patented be a "useful" invention.  Accordingly, a complete definition of
the scope of  35 U.S.C. 101, reflecting Congressional intent, is that
any new and useful process, machine, manufacture or composition of
matter under the sun that is made by man is the proper subject matter of
a patent.  Subject matter not within one of the four statutory invention
categories or which is not "useful" in a patent sense is, accordingly,
not eligible to be patented.

The subject matter courts have found to be outside the four statutory
categories of invention is limited to abstract ideas, laws of nature and
natural phenomena.  While this is easily stated, determining whether an
applicant is seeking to patent an abstract idea, a law of nature or a
natural phenomenon has proven to be challenging.  These three exclusions
recognize that subject matter that is not a practical application or use
of an idea, a law of nature or a natural phenomenon is not patentable. 
See, e.g., Rubber-Tip Pencil Co. v. Howard, 87 U.S. (20 Wall.) 498, 507
(1874) ("idea of itself is not patentable, but a new device by which it
may be made practically useful is"); Mackay Radio & Telegraph Co. v.  
Radio Corp. of America, 306 U.S. 86, 94, 40 USPQ 199, 202 (1939) ("While
a scientific truth, or the mathematical expression of it, is not
patentable invention, a novel and useful structure created with the aid
of knowledge of scientific truth may be."); Warmerdam,33 F.3d at 1360,
31 USPQ2d at 1759 ("steps of "locating" a medial axis, and `creating' a
bubble hierarchy . . . describe nothing more than the manipulation of
basic mathematical constructs, the paradigmatic "abstract idea"").

Courts have expressed a concern over "preemption" of ideas, laws of
nature or natural phenomena.  The concern over preemption was expressed
as early as 1852.  See Le Roy v. Tatham, 55 U.S. 156, 175 (1852) ("A
principle, in the abstract, is a fundamental truth; an original cause; a
motive; these cannot be patented, as no one can claim in either of them
an exclusive right."); Funk Brothers Seed Co. v. Kalo Inoculant Co., 333
U.S. 127, 132, 76 USPQ 280, 282 (1948) (combination of six species of
bacteria held to be nonstatutory subject matter).  The concern over
preemption serves to bolster and justify the prohibition against the
patenting of such subject matter.  In fact, such concerns are only
relevant to claiming a scientific truth or principle.  Thus, a claim to
an "abstract idea" is nonstatutory because it does not represent a
practical application of the idea, not because it would preempt the
idea.

B. Classify the Claimed Invention as to Its Proper Statutory Category

To properly determine whether a claimed invention complies with the
statutory invention requirements of  35 U.S.C. 101, Office personnel
should classify each claim into one or more statutory or nonstatutory
categories.  If the claim falls into a nonstatutory category, that
should not preclude complete examination of the application for
satisfaction of all other conditions of patentability.  This
classification is only an initial finding at this point in the
examination process that will be again assessed after the examination
for compliance with  35 U.S.C. 102, 103, and 112 is completed and before
issuance of any Office action on the merits.

If the invention as set forth in the written description is statutory,
but the claims define subject matter that is not, the deficiency can be
corrected by an appropriate amendment of the claims.  In such a case,
Office personnel should reject the claims drawn to nonstatutory subject
matter under  35 U.S.C. 101, but identify the features of the invention
that would render the claimed subject matter statutory if recited in the
claim.

1. Nonstatutory Subject Matter

Claims to computer-related inventions that are clearly nonstatutory fall
into the same general categories as nonstatutory claims in other arts,
namely natural phenomena such as magnetism, and abstract ideas or laws
of nature which constitute "descriptive material."  Descriptive material
can be characterized as either "functional descriptive material" or
"nonfunctional descriptive material."  In this context, "functional
descriptive material" consists of data structures and computer programs
which impart functionality when encoded on a computer-readable medium.
(The definition of "data structure" is "a physical or logical
relationship among data elements, designed to support specific data
manipulation functions."  The New IEEE Standard Dictionary of Electrical
and Electronics Terms 308 (5th ed. 1993).)  "Nonfunctional descriptive
material" includes but is not limited to music, literary works and a
compilation or mere arrangement of data.

Both types of "descriptive material" are nonstatutory when claimed as
descriptive material per se. When functional descriptive material is
recorded on some computer-readable medium it becomes structurally and
functionally interrelated to the medium and will be statutory in most
cases.  Compare In re Lowry, 32 F.3d 1579, 1583-84, 32 USPQ2d 1031, 1035
(Fed. Cir. 1994) (claim to data structure that increases computer
efficiency held statutory) and Warmerdam, 33 F.3d at 1360-61, 31 USPQ2d
at 1759 (claim to computer having specific memory held statutory
product-by-process claim) with Warmerdam, 33 F.3d at 1361, 31 USPQ2d at
1760 (claim to a data structure per se held nonstatutory).  When
nonfunctional descriptive material is recorded on some computer-readable
medium, it is not structurally and functionally interrelated to the
medium but is merely carried by the medium.  Merely claiming
nonfunctional descriptive material stored in a computer-readable medium
does not make it statutory.  Such a result would exalt form over
substance. In re Sarkar, 588 F.2d 1330, 1333, 200 USPQ 132, 137 (CCPA
1978)("[E]ach invention must be evaluated as claimed; yet semantogenic
considerations preclude a determination based solely on words appearing
in the claims.  In the final analysis under  101, the claimed invention,
as a whole, must be evaluated for what it is.") (quoted with approval in
Abele, 684 F.2d at 907, 214 USPQ at 687).  See also In re Johnson, 589
F.2d 1070, 1077, 200 USPQ 199, 206 (CCPA 1978) ("form of the claim is
often an exercise in drafting").  Thus, nonstatutory music does not
become statutory by merely recording it on a compact disk.  Protection
for this type of work is provided under the copyright law. 

Claims to processes that do nothing more than solve mathematical
problems or manipulate abstract ideas or concepts are more complex to
analyze and are addressed below.  See sections IV.B.2(d) and IV.B.2(e).

(a) Functional Descriptive Material: "Data Structures" Representing
Descriptive Material Per Se or Computer Programs Representing Computer
Listings Per Se

Data structures not claimed as embodied in computer-readable media are
descriptive material per se and are not statutory because they are
neither physical "things" nor statutory processes.  See, e.g.,
Warmerdam, 33 F.3d at 1361, 31 USPQ2d at 1760 (claim to a data structure
per se held nonstatutory).  Such claimed data structures do not define
any structural and functional interrelationships between the data
structure and other claimed aspects of the invention which permit the
data structure's functionality to be realized.  In contrast, a claimed
computer-readable medium encoded with a data structure defines
structural and functional interrelationships between the data structure
and the medium which permit the data structure's functionality to be
realized, and is thus statutory.

Similarly, computer programs claimed as computer listings per se, i.e.,
the descriptions or expressions of the programs, are not physical
"things," nor are they statutory processes, as they are not "acts" being
performed.  Such claimed computer programs do not define any structural
and functional interrelationships between the computer program and other
claimed aspects of the invention which permit the computer program's
functionality to be realized.  In contrast, a claimed computer-readable
medium encoded with a computer program defines structural and functional
interrelationships between the computer program and the medium which
permit the computer program's functionality to be realized, and is thus
statutory.  Accordingly, it is important to distinguish claims that
define descriptive material per se from claims that define statutory
inventions.

Computer programs are often recited as part of a claim.  Office
personnel should determine whether the computer program is being claimed
as part of an otherwise statutory manufacture or machine.  In such a
case, the claim remains statutory irrespective of the fact that a
computer program is included in the claim.  The same result occurs when
a computer program is used in a computerized process where the computer
executes the instructions set forth in the computer program.  Only when
the claimed invention taken as a whole is directed to a mere program
listing, i.e., to only its description or expression, is it descriptive
material per se and hence nonstatutory.

Since a computer program is merely a set of instructions capable of
being executed by a computer, the computer program itself is not a
process and Office personnel should treat a claim for a computer
program, without the computer-readable medium needed to realize the
computer program's functionality, as nonstatutory functional descriptive
material.  When a computer program is claimed in a process where the
computer is executing the computer program's instructions, Office
personnel should treat the claim as a process claim.  See Sections
IV.B.2(b)-(e).  When a computer program is recited in conjunction with a
physical structure, such as a computer memory, Office personnel should
treat the claim as a product claim.  See Section IV.B.2(a).

(b) Nonfunctional Descriptive Material

Descriptive material that cannot exhibit any functional
interrelationship with the way in which computing processes are
performed does not constitute a statutory process, machine, manufacture
or composition of matter and should be rejected under  35 U.S.C. 101.
Thus, Office personnel should consider the claimed invention as a whole
to determine whether the necessary functional interrelationship is
provided.

Where certain types of descriptive material, such as music, literature,
art, photographs and mere arrangements or compilations of facts or data,
are merely stored so as to be read or outputted by a computer without
creating any functional interrelationship, either as part of the stored
data or as part of the computing processes performed by the computer,
then such descriptive material alone does not impart functionality
either to the data as so structured, or to the computer.  Such
"descriptive material" is not a process, machine, manufacture or
composition of matter.  (Data consists of facts, which become
information when they are seen in context and convey meaning to people. 
Computers process data without any understanding of what that data
represents.  Computer Dictionary 210 (Microsoft Press, 2d ed. 1994).)

The policy that precludes the patenting of nonfunctional descriptive
material would be easily frustrated if the same descriptive material
could be patented when claimed as an article of manufacture.  For
example, music is commonly sold to consumers in the format of a compact
disc.  In such cases, the known compact disc acts as nothing more than a
carrier for nonfunctional descriptive material.  The purely
nonfunctional descriptive material cannot alone provide the practical
application for the manufacture.

Office personnel should be prudent in applying the foregoing guidance. 
Nonfunctional descriptive material may be claimed in combination with
other functional descriptive material on a computer-readable medium to
provide the necessary functional and structural interrelationship to
satisfy the requirements of  35 U.S.C. 101.  The presence of the claimed
nonfunctional descriptive material is not necessarily determinative of
nonstatutory subject matter.  For example, a computer that recognizes a
particular grouping of musical notes read from memory and upon
recognizing that particular sequence, causes another defined series of
notes to be played, defines a functional interrelationship among that
data and the computing processes performed when utilizing that data, and
as such is statutory because it implements a statutory process.

(c) Natural Phenomena Such as Electricity and Magnetism

Claims that recite nothing but the physical characteristics of a form of
energy, such as a frequency, voltage, or the strength of a magnetic
field, define energy or magnetism, per se, and as such are nonstatutory
natural phenomena. O'Reilly v. Morse, 56 U.S. (15 How.) at 112-114. 
However, a claim directed to a practical application of a natural
phenomenon such as energy or magnetism is statutory.    Id. at  
114-119.  

2. Statutory Subject Matter

(a) Statutory Product Claims

Products may be either machines, manufactures of compositions of matter.

A machine is "a concrete thing, consisting of parts or of certain
devices and combinations of devices." Burr v. Duryee, 68 U.S. (1 Wall.)
531, 570 (1863).

A manufacture is "the production of articles for use from raw or
prepared materials by giving to these materials new forms, qualities,
properties or combinations, whether by hand labor or by machinery."
Diamond v. Chakrabarty, 447 U.S. at 308, 206 USPQ at 196-97 (quoting
American Fruit Growers, Inc. v. Brogdex Co., 283 U.S. 1, 11 (1931).

A composition of matter is "a composition[] of two or more substances
[or] . . . a[] composite article[], whether [it] be the result of
chemical union, or of mechanical mixture, whether . . . [it]be [a]
gas[], fluid[], powder[], or solid[]." Diamond v. Chakrabarty, 447 U.S.
at 308, 206 USPQ at 197 (quoting Shell Development Co. v. Watson, 149 F.
Supp. 279, 280, 113 USPQ 265, 266 (D.D.C. 1957), aff'd per curiam, 252
F.2d 861, 116 USPQ 428 (D.C. Cir. 1958).

If a claim defines a useful machine or manufacture by identifying the
physical structure of the machine or manufacture in terms of its
hardware or hardware and software combination, it defines a statutory
product.  See, e.g., Lowry, 32 F.3d at 1583, 32 USPQ2d at 1034-35;
Warmerdam, 33 F.3d at 1361-62, 31 USPQ2d at 1760.

A machine or manufacture claim may be one of two types:  (1) a claim
that encompasses any and every machine for performing the underlying
process or any and every manufacture that can cause a computer to
perform the underlying process, or (2) a claim that defines a specific
machine or manufacture.  When a claim is of the first type, Office
personnel are to evaluate the underlying process the computer will
perform in order to determine the patentability of the product.

i) Claims That Encompass Any Machine or Manufacture Embodiment of a
Process

Office personnel must treat each claim as a whole.  The mere fact that a
hardware element is recited in a claim does not necessarily limit the
claim to a specific machine or manufacture. Cf. In re Iwahashi, 888 F.2d
1370, 1374-75, 12 USPQ2d 1908, 1911-12 (Fed. Cir. 1989), cited with
approval in Alappat, 33 F.3d at 1544 n.24, 31 USPQ2d at 1558 n.24.  If a
product claim encompasses any and every computer implementation of a
process, when read in light of the specification, it should be examined
on the basis of the underlying process.  Such a claim can be recognized
as it will:

(A) define the physical characteristics of a computer or computer
component exclusively as functions or steps to be performed on or by a
computer, and

(B) encompass any and every product in the stated class (e.g., computer,
computer-readable memory) configured in any manner to perform that
process.

Office personnel are reminded that finding a product claim to encompass
any and every product embodiment of a process invention simply means
that the Office will presume that the product claim encompasses any and
every hardware or hardware platform and associated software
implementation that performs the specified set of claimed functions. 
Because this is interpretive and nothing more, it does not provide any
information as to the patentability of the applicant's underlying
process or the product claim.

When Office personnel have reviewed the claim as a whole and found that
it is not limited to a specific machine or manufacture, they shall
identify how each claim limitation has been treated and set forth their
reasons in support of their conclusion that the claim encompasses any
and every machine or manufacture embodiment of a process.  This will
shift the burden to applicant to demonstrate why the claimed invention
should be limited to a specific machine or manufacture.

If a claim is found to encompass any and every product embodiment of the
underlying process, and if the underlying process is statutory, the
product claim should be classified as a statutory product.  By the same
token, if the underlying process invention is found to be nonstatutory,
Office personnel should classify the "product" claim as a "nonstatutory
product."  If the product claim is classified as being a nonstatutory
product on the basis of the underlying process, Office personnel should
emphasize that they have considered all claim limitations and are basing
their finding on the analysis of the underlying process.

ii) Product Claims - Claims Directed to Specific Machines and
Manufactures

If a product claim does not encompass any and every
computer-implementation of a process, then it must be treated as a
specific machine or manufacture.  Claims that define a computer-related
invention as a specific machine or specific article of manufacture must
define the physical structure of the machine or manufacture in terms of
its hardware or hardware and "specific software." ("Specific software"
is defined as a set of instructions implemented in a specific program
code segment.  See Computer Dictionary 78 (Microsoft Press, 2d ed. 1994)
for definition of "code segment.")  The applicant may define the
physical structure of a programmed computer or its hardware or software
components in any manner that can be clearly understood by a person
skilled in the relevant art.  Generally a claim drawn to a particular
programmed computer should identify the elements of the computer and
indicate how those elements are configured in either hardware or a
combination of hardware and specific software.

To adequately define a specific computer memory, the claim must identify
a general or specific memory and the specific software which provides
the functionality stored in the memory.

A claim limited to a specific machine or manufacture, which has a
practical application in the technological arts, is statutory.  In most
cases, a claim to a specific machine or manufacture will have a
practical application in the technological arts.

iii) Hypothetical Machine Claims Which Illustrate Claims of the Types
Described in Sections IV.B.2(a), i) and ii)

Two applicants present a claim to the following process:

A process for determining and displaying the structure of a chemical
compound comprising:

(a) solving the wavefunction parameters for the compound to determine
the structure of a compound; and

(b) displaying the structure of the compound determined in step (a).

Each applicant also presents a claim to the following apparatus:

A computer system for determining the three dimensional structure of a
chemical compound comprising:

(a) means for determining the three dimensional structure of a compound;
and

(b) means for creating and displaying an image representing a
three-dimensional perspective of the compound.

In addition, each applicant provides the noted disclosures to support
the claims:



	Applicant A	Applicant B

Disclosure	The disclosure describes specific software, i.e., specific
program code segments, that are to be employed to configure a general
purpose microprocessor to create specific logic circuits.  These
circuits are indicated to be the "means" corresponding to the claimed
means limitations.	The disclosure states that it would be a matter of
routine skill to select an appropriate conventional computer system and
implement the claimed process on that computer system.  The disclosure
does not have specific disclosure that corresponds to the two "means"
limitations recited in the claim (i.e., no specific software or logic
circuit).  The disclosure does have an explanation of how to solve the
wavefunction equations of a chemical compound, and indicates that the
solutions of those wavefunction equations can be employed to determine
the physical structure of the corresponding compound.

Result	Claim defines specific computer, patentability stands
independently from process claim.	Claim encompasses any computer
embodiment of process claim; patentability stands or falls with process
claim.

Explanation	Disclosure identifies the specific machine capable of
performing the indicated functions.	Disclosure does not provide any
information to distinguish the "implementation" of the process on a
computer from the factors that will govern the patentability
determination of the process per se.  As such, the patentability of this
apparatus claim will stand or fall with that of the process claim.

(b) Statutory Process Claims

A claim that requires one or more acts to be performed defines a
process.  However, not all processes are statutory under  35 U.S.C. 101. 
To be statutory, a claimed computer-related process must either:  (A)
result in a physical transformation outside the computer for which a
practical application in the technological arts is either disclosed in
the specification or would have been known to a skilled artisan
(discussed in i) below), or (B) be limited by the language in the claim
to a practical application within the technological arts (discussed in
ii) below).  See Diamond v. Diehr, 450 U.S. at 183-84, 209 USPQ at 6
(quoting Cochrane v. Deener, 94 U.S. 780, 787-88 (1877)) ("A [statutory]
process is a mode of treatment of certain materials to produce a given
result.  It is an act, or a series of acts, performed upon the
subject-matter to be transformed and reduced to a different state or
thing. . . .  The process requires that certain things should be done
with certain substances, and in a certain order; but the tools to be
used in doing this may be of secondary consequence."). See also Alappat,
33 F.3d at 1543, 31 USPQ2d at 1556-57 (quoting Diamond v. Diehr, 450
U.S. at 192, 209 USPQ at 10).  See also   id. at 33 F.3d 1569, 31 USPQ2d
at 1578-79 (Newman, J., concurring) ("unpatentability of the principle
does not defeat patentability of its practical applications") (citing
O`Reilly v. Morse, 56 U.S. (15 How.) at 114-19). The claimed practical
application must be a further limitation upon the claimed subject matter
if the process is confined to the internal operations of the computer. 
If a physical transformation occurs outside the computer, it is not
necessary to claim the practical application.  A disclosure that permits
a skilled artisan to practice the claimed invention, i.e., to put it to
a practical use, is sufficient.  On the other hand, it is necessary to
claim the practical application if there is no physical transformation
or if the process merely manipulates concepts or converts one set of
numbers into another.

A claimed process is clearly statutory if it results in a physical
transformation outside the computer, i.e., falls into one or both of the
following specific categories ("safe harbors").

i) Safe Harbors

 -	Independent Physical Acts (Post-Computer Process Activity)

A process is statutory if it requires physical acts to be performed
outside the computer independent of and following the steps to be
performed by a programmed computer, where those acts involve the
manipulation of tangible physical objects and result in the object
having a different physical attribute or structure. Diamond v. Diehr,
450 U.S. at 187, 209 USPQ at 8. Thus, if a process claim includes one or
more post-computer process steps that result in a physical
transformation outside the computer (beyond merely conveying the direct
result of the computer operation, see Section IV.B.2(d)iii)), the claim
is clearly statutory.

Examples of this type of statutory process include the following:

- A method of curing rubber in a mold which relies upon updating process
parameters, using a computer processor to determine a time period for
curing the rubber, using the computer processor to determine when the
time period has been reached in the curing process and then opening the
mold at that stage.

- A method of controlling a mechanical robot which relies upon storing
data in a computer that represents various types of mechanical movements
of the robot, using a computer processor to calculate positioning of the
robot in relation to given tasks to be performed by the robot, and
controlling the robot's movement and position based on the calculated
position.

 -	Manipulation of Data Representing Physical Objects or Activities
(Pre-Computer Process Activity)

Another statutory process is one that requires the measurements of
physical objects or activities to be transformed outside of the computer
into computer data (In re Gelnovatch, 595 F.2d 32, 41 n.7, 201 USPQ 136,
145 n.7 (CCPA 1979) (data-gathering step did not measure physical
phenomenon)), where the data comprises signals corresponding to physical
objects or activities external to the computer system, and where the
process causes a physical transformation of the signals which are
intangible representations of the physical objects or activities.
Schrader, 22 F.3d at 294, 30 USPQ2d at 1459 citing with approval
Arrhythmia, 958 F.2d at 1058-59, 22 USPQ2d at 1037-38; Abele, 684 F.2d
at 909, 214 USPQ at 688; In re Taner, 681 F.2d 787, 790, 214 USPQ 678,
681 (CCPA 1982).

Examples of this type of claimed statutory process include the
following:

- A method of using a computer processor to analyze electrical signals
and data representative of human cardiac activity by converting the
signals to time segments, applying the time segments in reverse order to
a high pass filter means, using the computer processor to determine the
amplitude of the high pass filter's output, and using the computer
processor to compare the value to a predetermined value.  In this
example the data is an intangible representation of physical activity,
i.e., human cardiac activity.  The transformation occurs when heart
activity is measured and an electrical signal is produced.  This process
has real world value in predicting vulnerability to ventricular
tachycardia immediately after a heart attack.

- A method of using a computer processor to receive data representing
Computerized Axial Tomography ("CAT") scan images of a patient,
performing a calculation to determine the difference between a local
value at a data point and an average value of the data in a region
surrounding the point, and displaying the difference as a gray scale for
each point in the image, and displaying the resulting image.  In this
example the data is an intangible representation of a physical object,
i.e., portions of the anatomy of a patient.  The transformation occurs
when the condition of the human body is measured with X-rays and the
X-rays are converted into electrical digital signals that represent the
condition of the human body.  The real world value of the invention lies
in creating a new CAT scan image of body tissue without the presence of
bones.

- A method of using a computer processor to conduct seismic exploration,
by imparting spherical seismic energy waves into the earth from a
seismic source, generating a plurality of reflected signals in response
to the seismic energy waves at a set of receiver positions in an array,
and summing the reflection signals to produce a signal simulating the
reflection response of the earth to the seismic energy.  In this
example, the electrical signals processed by the computer represent
reflected seismic energy. The transformation occurs by converting the
spherical seismic energy waves into electrical signals which provide a
geophysical representation of formations below the earth's surface.
Geophysical exploration of formations below the surface of the earth has
real world value.

If a claim does not clearly fall into one or both of the safe harbors,
the claim may still be statutory if it is limited by the language in the
claim to a practical application in the technological arts.

ii) Computer-Related Processes Limited to a Practical Application in the
Technological Arts

There is always some form of physical transformation within a computer
because a computer acts on signals and transforms them during its
operation and changes the state of its components during the execution
of a process.  Even though such a physical transformation occurs within
a computer, such activity is not determinative of whether the process is
statutory because such transformation alone does not distinguish a
statutory computer process from a nonstatutory computer process. What is
determinative is not how the computer performs the process, but what the
computer does to achieve a practical application.  See   Arrhythmia, 958
F.2d at 1057, 22 USPQ2d at 1036.

A process that merely manipulates an abstract idea or performs a purely
mathematical algorithm is nonstatutory despite the fact that it might
inherently have some usefulness.  In Sarkar, 588 F.2d at 1335, 200 USPQ
at 139, the court explained why this approach must be followed:

No mathematical equation can be used, as a practical matter, without
establishing and substituting values for the variables expressed
therein.  Substitution of values dictated by the formula has thus been
viewed as a form of mathematical step.  If the steps of gathering and
substituting values were alone sufficient, every mathematical equation,
formula, or algorithm having any practical use would be per se subject
to patenting as a "process" under  101.  Consideration of whether the
substitution of specific values is enough to convert the disembodied
ideas present in the formula into an embodiment of those ideas, or into
an application of the formula, is foreclosed by the current state of the
law.

For such subject matter to be statutory, the claimed process must be
limited to a practical application of the abstract idea or mathematical
algorithm in the technological arts.  See Alappat, 33 F.3d at 1543, 31
USPQ2d at 1556-57 (quoting Diamond v. Diehr, 450 U.S. at 192, 209 USPQ
at 10).  See also Alappat at 1569, 31 USPQ2d at 1578-79 (Newman, J.,
concurring) ("unpatentability of the principle does not defeat
patentability of its practical applications") (citing O"Reilly v. Morse,
56 U.S. (15 How.) at 114-19). For example, a computer process that
simply calculates a mathematical algorithm that models noise is
nonstatutory. However, a claimed process for digitally filtering noise
employing the mathematical algorithm is statutory.

Examples of this type of claimed statutory process include the
following:

 - A computerized method of optimally controlling transfer, storage and
retrieval of data between cache and hard disk storage devices such that
the most frequently used data is readily available.

 - A method of controlling parallel processors to accomplish
multi-tasking of several computing tasks to maximize computing
efficiency.  See, e.g., In re Bernhart, 417 F.2d 1395, 1400, 163 USPQ
611,616 (CCPA 1969).

 - A method of making a word processor by storing an executable word
processing application program in a general purpose digital computer's
memory, and executing the stored program to impart word processing
functionality to the general purpose digital computer by changing the
state of the computer's arithmetic logic unit when program instructions
of the word processing program are executed.

 - A digital filtering process for removing noise from a digital signal comprising
the steps of calculating a mathematical algorithm to produce a
correction signal and subtracting the correction signal from the digital
signal to remove the noise.

(c) Nonstatutory Process Claims

If the "acts" of a claimed process manipulate only numbers, abstract
concepts or ideas, or signals representing any of the foregoing, the
acts are not being applied to appropriate subject matter.  Thus, a
process consisting solely of mathematical operations, i.e., converting
one set of numbers into another set of numbers, does not manipulate
appropriate subject matter and thus cannot constitute a statutory
process.

In practical terms, claims define nonstatutory processes if they:

 - consist solely of mathematical operations without some claimed
practical application (i.e., executing a "mathematical algorithm"); or

 - simply manipulate abstract ideas, e.g., a bid (Schrader, 22 F.3d at
293-94, 30 USPQ2d at 1458-59) or a bubble hierarchy (Warmerdam, 33 F.3d
at 1360, 31 USPQ2d at 1759), without some claimed practical application.

A claimed process that consists solely of mathematical operations is
nonstatutory whether or not it is performed on a computer.  Courts have
recognized a distinction between types of mathematical algorithms,
namely, some define a "law of nature" in mathematical terms and others
merely describe an "abstract idea."  See, e.g., In re Meyer, 688 F.2d
789, 794-95, 215 USPQ 193, 197 (CCPA 1982)

Scientific principles, such as the relationship between mass and energy,
and laws of nature, such as the acceleration of gravity, namely, a = 32
ft./sec.2, can be represented in mathematical format.  However, some
mathematical algorithms and formulae do not represent scientific
principles or laws of nature; they represent ideas or mental processes
and are simply logical vehicles for communicating possible solutions to
complex problems.  The presence of a mathematical algorithm or formula
in a claim is merely an indication that a scientific principle, law of
nature, idea or mental process may be the subject matter claimed and,
thus, justify a rejection of that claim under 35 U.S.C  101; but the
presence of a mathematical algorithm or formula is only a signpost for
further analysis.  (Emphasis in original.)        Cf. Alappat, 33 F.3d
at 1543 n.19, 31 USPQ2d at 1556 n.19 in which the Federal Circuit
recognized the confusion:

The Supreme Court has not been clear . . . as to whether such subject
matter is excluded from the scope of  101 because it represents laws of
nature, natural phenomena, or abstract ideas. See Diehr, 450 U.S. at 186
(viewed mathematical algorithm as a law of nature); Gottschalk v.
Benson, 409 U.S. 63, 71-72 (1972) (treated mathematical algorithm as an
"idea").  The Supreme Court also has not been clear as to exactly what
kind of mathematical subject matter may not be patented.  The Supreme
Court has used, among others, the terms "mathematical algorithm,"
"mathematical formula," and "mathematical equation" to describe types of
mathematical subject matter not entitled to patent protection standing
alone.  The Supreme Court has not set forth, however, any consistent or
clear explanation of what it intended by such terms or how these terms
are related, if at all.

Certain mathematical algorithms have been held to be nonstatutory
because they represent a mathematical definition of a law of nature or a
natural phenomenon.  For example, a mathematical algorithm representing
the formula E = mc2 is a "law of nature" - it defines a "fundamental
scientific truth" (i.e., the relationship between energy and mass).  To
comprehend how the law of nature relates to any object, one invariably
has to perform certain steps (e.g., multiplying a number representing
the mass of an object by the square of a number representing the speed
of light).  In such a case, a claimed process which consists solely of
the steps that one must follow to solve the mathematical representation
of E = mc2 is indistinguishable from the law of nature and would
"preempt" the law of nature.  A patent cannot be granted on such a
process.

Other mathematical algorithms have been held to be nonstatutory because
they merely describe an abstract idea.  An "abstract idea" may simply be
any sequence of mathematical operations that are combined to solve a
mathematical problem.  The concern addressed by holding such subject
matter nonstatutory is that the mathematical operations merely describe
an idea and do not define a process that represents a practical
application of the idea.

Accordingly, when a claim reciting a mathematical algorithm is found to
define nonstatutory subject matter the basis of the  35 U.S.C. 101
rejection must be that, when taken as a whole, the claim recites a law
of nature, a natural phenomenon, or an abstract idea.

(d) Certain Claim Language Related to Mathematical Operation Steps of a
Process

i) Intended Use or Field of Use Statements

Claim language that simply specifies an intended use or field of use for
the invention generally will not limit the scope of a claim,
particularly when only presented in the claim preamble.  Thus, Office
personnel should be careful to properly interpret such language. Walter,
618 F.2d at 769, 205 USPQ at 409 (Because none of the claimed steps were
explicitly or implicitly limited to their application in seismic
prospecting activities, the court held that "[a]lthough the claim
preambles relate the claimed invention to the art of seismic
prospecting, the claims themselves are not drawn to methods of or
apparatus for seismic prospecting; they are drawn to improved
mathematical methods for interpreting the results of seismic
prospecting.").  Cf. Alappat, 33 F.3d at 1544, 31 USPQ2d at 1558.  When
such language is treated as nonlimiting, Office personnel should
expressly identify in the Office action the claim language that
constitutes the intended use or field of use statements and provide the
basis for their findings.  This will shift the burden to applicant to
demonstrate why the language is to be treated as a claim limitation.

ii) Necessary Antecedent Step to Performance of a Mathematical Operation
or Independent Limitation on a Claimed Process

In some situations, certain acts of "collecting" or "selecting" data for
use in a process consisting of one or more mathematical operations will
not further limit a claim beyond the specified mathematical operation
step(s).  Such acts merely determine values for the variables used in
the mathematical formulae used in making the calculations. Walter, 618
F.2d at 769-70, 205 USPQ at 409.  In other words, the acts are dictated
by nothing other than the performance of a mathematical operation.
Sarker, 588 F.2d at 1335, 200 USPQ at 139.

If a claim requires acts to be performed to create data that will then
be used in a process representing a practical application of one or more
mathematical operations, those acts must be treated as further limiting
the claim beyond the mathematical operation(s) per se.  Such acts are
data gathering steps not dictated by the algorithm but by other
limitations which require certain antecedent steps and as such
constitute an independent limitation on the claim.

Examples of acts that independently limit a claimed process involving
mathematical operations include:

- a method of conducting seismic exploration which requires generating
and manipulating signals from seismic energy waves before "summing" the
values represented by the signals (Taner, 681 F.2d at 788, 214 USPQ at
679); and

- a method of displaying X-ray attenuation data as a signed gray scale
signal in a "field" using a particular algorithm, where the antecedent
steps require generating the data using a particular machine (e.g., a
computer tomography scanner). Abele, 684 F.2d at 908, 214 USPQ at 687
("The specification indicates that such attenuation data is available
only when an X-ray beam is produced by a CAT scanner, passed through an
object, and detected upon its exit.  Only after these steps have been
completed is the algorithm performed, and the resultant modified data
displayed in the required format.").

Examples of steps that do not independently limit one or more
mathematical operation steps include:

- "perturbing" the values of a set of process inputs, where the subject
matter "perturbed" was a number and the act of "perturbing" consists of
substituting the numerical values of variables (Gelnovatch, 595 F.2d at
41 n.7, 201 USPQ at 145 n.7 ("Appellants' claimed step of perturbing the
values of a set of process inputs (step 3), in addition to being a
mathematical operation, appears to be a data-gathering step of the type
we have held insufficient to change a nonstatutory method of calculation
into a statutory process -- . In this instance, the perturbed process
inputs are not even measured values of physical phenomena, but are
instead derived by numerically changing the values in the previous set
of process inputs.")); and

- selecting a set of arbitrary measurement point values (Sarkar, 588
F.2d at 1331, 200 USPQ at 135).

Such steps do not impose independent limitations on the scope of the
claim beyond those required by the mathematical operation limitation.

iii) Post-Mathematical Operation Step Using Solution or Merely Conveying
Result of Operation

In some instances, certain kinds of post-solution "acts" will not
further limit a process claim beyond the performance of the preceding
mathematical operation step even if the acts are recited in the body of
a claim.  If, however, the claimed acts represent some "significant use"
of the solution, those acts will invariably impose an independent
limitation on the claim.  A "significant use" is any activity which is
more than merely outputting the direct result of the mathematical
operation. Office personnel are reminded to rely on the applicant's
characterization of the significance of the acts being assessed to
resolve questions related to their relationship to the mathematical
operations recited in the claim and the invention as a whole.  See
Sarkar, 588 F.2d at 1332 n.6, 200 USPQ at 136 n.6 ("post-solution"
construction that was being modeled by the mathematical process not
considered in deciding  35 U.S.C. 101 question because applicant
indicated that such construction was not a material element of the
invention).  Thus, if a claim requires that the direct result of a
mathematical operation be evaluated and transformed into something else,
Office personnel cannot treat the subsequent steps as being
indistinguishable from the performance of the mathematical operation and
thus not further limiting on the claim.  For example, acts that require
the conversion of a series of numbers representing values of a
wavefunction equation for a chemical compound into values representing
an image that conveys information about the three-dimensional structure
of the compound and the displaying of the three-dimensional structure
cannot be treated as being part of the mathematical operations.

Office personnel should be especially careful when reviewing claim
language that requires the performance of "post-solution" steps to
ensure that claim limitations are not ignored.

Examples of steps found not to independently limit a process involving
one or more mathematical operation steps include:

- step of "updating alarm limits" found to constitute changing the
number value of a variable to represent the result of the calculation
(Parker v. Flook, 437 U.S. 584, 585, 198 USPQ 193, 195 (1978));

- final step of magnetically recording the result of a calculation
(Walter, 618 F.2d at 770, 205 USPQ at 409 ("If  101 could be satisfied
by the mere recordation of the results of a nonstatutory process on some
record medium, even the most unskilled patent draftsman could provide
for such a step."));

- final step of "equating" the process outputs to the values of the last
set of process inputs found to constitute storing the result of
calculations (Gelnovatch, 595 F.2d at 41 n.7, 201 USPQ at 145 n.7);

- final step of displaying result of a calculation "as a shade of gray
rather than as simply a number" found to not constitute distinct step
where the data were numerical values that did not represent anything
(Abele, 684 F.2d at 909, 214 USPQ at 688 ("This claim presents no more
than the calculation of a number and display of the result, albeit in a
particular format.  The specification provides no greater meaning to
`data in a field' than a matrix of numbers regardless of by what method
generated.  Thus, the algorithm is neither explicitly nor implicitly
applied to any certain process.  Moreover, that the result is displayed
as a shade of gray rather than as simply a number provides no greater or
better information, considering the broad range of applications
encompassed by the claim.")); and

- step of "transmitting electrical signals representing" the result of
calculations (In re De Castelet, 562 F.2d 1236, 1244, 195 USPQ 439, 446
(CCPA 1977) ("That the computer is instructed to transmit electrical
signals, representing the results of its calculations, does not
constitute the type of `post solution activity' found in Flook, [437
U.S. 584, 198 USPQ 193 (1978)], and does not transform the claim into
one for a process merely using an algorithm.  The final transmitting
step constitutes nothing more than reading out the result of the
calculations.")).

(e) Manipulation of Abstract Ideas Without a Claimed Practical
Application

A process that consists solely of the manipulation of an abstract idea
without any limitation to a practical application is nonstatutory.  See,
e.g., Warmerdam, 33 F.3d at 1360, 31 USPQ2d at 1759.  See also Schrader,
22 F.3d at 295, 30 USPQ2d at 1459.  Office personnel have the burden to
establish a prima facie case that the claimed invention taken as a whole
is directed to the manipulation of abstract ideas without a practical
application.

In order to determine whether the claim is limited to a practical
application of an abstract idea, Office personnel must analyze the claim
as a whole, in light of the specification, to understand what subject
matter is being manipulated and how it is being manipulated.  During
this procedure, Office personnel must evaluate any statements of
intended use or field of use, any data gathering step and any
post-manipulation activity. See section IV.B.2(d) above for how to treat
various types of claim language.  Only when the claim is devoid of any
limitation to a practical application in the technological arts should
it be rejected under  35 U.S.C. 101.  Further, when such a rejection is
made, Office personnel must expressly state how the language of the
claims has been interpreted to support the rejection.

V. EVALUATE APPLICATION FOR COMPLIANCE WITH 35 U.S.C. 112

Office personnel should begin their evaluation of an application's
compliance with  35 U.S.C. 112 by considering the requirements of  35
U.S.C. 112, second paragraph. The second paragraph contains two separate
and distinct requirements: (A) that the claim(s) set forth the subject
matter applicants regard as the invention, and (B) that the claim(s)
particularly point out and distinctly claim the invention. An
application will be deficient under  35 U.S.C. 112, second paragraph
when (A) evidence including admissions, other than in the application as
filed, shows applicant has stated that he or she regards the invention
to be different from what is claimed, or when (B) the scope of the
claims is unclear.

After evaluation of the application for compliance with  35 U.S.C. 112,
second paragraph, Office personnel should then evaluate the application
for compliance with the requirements of  35 U.S.C. 112, first paragraph.
The first paragraph contains three separate and distinct requirements:

(A) adequate written description,

(B) enablement, and

(C) best mode.

An application will be deficient under  35 U.S.C. 112, first paragraph
when the written description is not adequate to identify what the
applicant has invented, or when the disclosure does not enable one
skilled in the art to make and use the invention as claimed without
undue experimentation. Deficiencies related to disclosure of the best
mode for carrying out the claimed invention are not usually encountered
during examination of an application because evidence to support such a
deficiency is seldom in the record.

If deficiencies are discovered with respect to  35 U.S.C. 112, Office
personnel must be careful to apply the appropriate paragraph of  35
U.S.C. 112.

A. Determine Whether the Claimed Invention Complies with 35 U.S.C. 112,
Second Paragraph Requirements

1. Claims Setting Forth the Subject Matter Applicant Regards as
Invention

Applicant's specification must conclude with claim(s) that set forth the
subject matter which the applicant regards as the invention. The
invention set forth in the claims is presumed to be that which applicant
regards as the invention, unless applicant considers the invention to be
something different from what has been claimed as shown by evidence,
including admissions, outside the application as filed. An applicant may
change what he or she regards as the invention during the prosecution of
the application.

2. Claims Particularly Pointing Out and Distinctly Claiming the
Invention

Office personnel shall determine whether the claims set out and
circumscribe the invention with a reasonable degree of precision and
particularity. In this regard, the definiteness of the language must be
analyzed, not in a vacuum, but always in light of the teachings of the
disclosure as it would be interpreted by one of ordinary skill in the
art. Applicant's claims, interpreted in light of the disclosure, must
reasonably apprise a person of ordinary skill in the art of the
invention. However, the applicant need not explicitly recite in the
claims every feature of the invention. For example, if an applicant
indicates that the invention is a particular computer, the claims do not
have to recite every element or feature of the computer. In fact, it is
preferable for claims to be drafted in a form that emphasizes what the
applicant has invented (i.e., what is new rather than old).

A means plus function limitation is distinctly claimed if the
description makes it clear that the means corresponds to well-defined
structure of a computer or computer component implemented in either
hardware or software and its associated hardware platform. Such means
may be defined as:

- a programmed computer with a particular functionality implemented in
hardware or hardware and software;

- a logic circuit or other component of a programmed computer that
performs a series of specifically identified operations dictated by a
computer program; or

- a computer memory encoded with executable instructions representing a
computer program that can cause a computer to function in a particular
fashion.

The scope of a "means" limitation is defined as the corresponding
structure or material (e.g., a specific logic circuit) set forth in the
written description and equivalents.  See MPEP Section  2181 through
Section  2186. Thus, a claim using means plus function limitations
without corresponding disclosure of specific structures or materials
that are not well-known fails to particularly point out and distinctly
claim the invention. For example, if the applicant discloses only the
functions to be performed and provides no express, implied or inherent
disclosure of hardware or a combination of hardware and software that
performs the functions, the application has not disclosed any
"structure" which corresponds to the claimed means. Office personnel
should reject such claims under  35 U.S.C. 112, second paragraph. The
rejection shifts the burden to the applicant to describe at least one
specific structure or material that corresponds to the claimed means in
question, and to identify the precise location or locations in the
specification where a description of at least one embodiment of that
claimed means can be found. In contrast, if the corresponding structure
is disclosed to be a memory or logic circuit that has been configured in
some manner to perform that function (e.g., using a defined computer
program), the application has disclosed "structure" which corresponds to
the claimed means.

When a claim or part of a claim is defined in computer program code,
whether in source or object code format, a person of skill in the art
must be able to ascertain the metes and bounds of the claimed invention.
In certain circumstances, as where self-documenting programming code is
employed, use of programming language in a claim would be permissible
because such program source code presents "sufficiently high-level
language and descriptive identifiers" to make it universally understood
to others in the art without the programmer having to insert any
comments. See Computer Dictionary 353 (Microsoft Press, 2ed. 1994) for a
definition of "self-documenting code." Applicants should be encouraged
to functionally define the steps the computer will perform rather than
simply reciting source or object code instructions.

B. Determine Whether the Claimed Invention Complies with 35 U.S.C. 112,
First Paragraph Requirements

1. Adequate Written Description

The satisfaction of the enablement requirement does not satisfy the
written description requirement. See In re Barker, 559 F.2d 588, 591,
194 USPQ 470, 472 (CCPA 1977), cert. denied, Barker v. Parker, 434 U.S.
1064 (1978) (a specification may be sufficient to enable one skilled in
the art to make and use the invention, but still fail to comply with the
written description requirement). See also In re DiLeone, 436 F.2d 1404,
1405, 168 USPQ 592, 593 (CCPA 1971). For the written description
requirement, an applicant's specification must reasonably convey to
those skilled in the art that the applicant was in possession of the
claimed invention as of the date of invention. The claimed invention
subject matter need not be described literally, i.e., using the same
terms, in order for the disclosure to satisfy the description
requirement.

2. Enabling Disclosure

An applicant's specification must enable a person skilled in the art to
make and use the claimed invention without undue experimentation. The
fact that experimentation is complex, however, will not make it undue if
a person of skill in the art typically engages in such complex
experimentation. For a computer-related invention, the disclosure must
enable a skilled artisan to configure the computer to possess the
requisite functionality, and, where applicable, interrelate the computer
with other elements to yield the claimed invention, without the exercise
of undue experimentation. The specification should disclose how to
configure a computer to possess the requisite functionality or how to
integrate the programmed computer with other elements of the invention,
unless a skilled artisan would know how to do so without such
disclosure. See, e.g., Northern Telecom v. Datapoint Corp., 908 F.2d
931, 941-43, 15 USPQ2d 1321, 1328-30 (Fed. Cir.), cert. denied,
Datapoint Corp. v. Northern Telecom, 498 U.S. 920 (1990) (judgment of
invalidity reversed for clear error where expert testimony on both sides
showed that a programmer of reasonable skill could write a satisfactory
program with ordinary effort based on the disclosure); DeGeorge v.
Bernier, 768 F.2d 1318, 1324, 226 USPQ 758, 762-63 (Fed. Cir. 1985)
(superseded by statute with respect to issues not relevant here)
(invention was adequately disclosed for purposes of enablement even
though all of the circuitry of a word processor was not disclosed, since
the undisclosed circuitry was deemed inconsequential because it did not
pertain to the claimed circuit); In re Phillips, 608 F.2d 879, 882-83,
203 USPQ 971, 975 (CCPA 1979) (computerized method of generating printed
architectural specifications dependent on use of glossary of predefined
standard phrases and error-checking feature enabled by overall
disclosure generally defining errors); In re Donohue, 550 F.2d 1269,
1271, 193 USPQ 136, 137 (CCPA 1977) ("Employment of block diagrams and
descriptions of their functions is not fatal under  35 U.S.C. 112, first
paragraph, providing the represented structure is conventional and can
be determined without undue experimentation."); In re Knowlton, 481 F.2d
1357, 1366-68, 178 USPQ 486, 493-94 (CCPA 1973) (examiner's contention
that a software invention needed a detailed description of all the
circuitry in the complete hardware system reversed).

For many computer-related inventions, it is not unusual for the claimed
invention to involve more than one field of technology. For such
inventions, the disclosure must satisfy the enablement standard for each
aspect of the invention. See In re Naquin, 398 F.2d 863, 866, 158 USPQ
317, 319 (CCPA 1968) ("When an invention, in its different aspects,
involves distinct arts, that specification is adequate which enables the
adepts of each art, those who have the best chance of being enabled, to
carry out the aspect proper to their specialty."); Ex parte Zechnall,
194 USPQ 461, 461 (Bd. App. 1973) ("appellants' disclosure must be held
sufficient if it would enable a person skilled in the electronic
computer art, in cooperation with a person skilled in the fuel injection
art, to make and use appellants' invention"). As such, the disclosure
must teach a person skilled in each art how to make and use the relevant
aspect of the invention without undue experimentation. For example, to
enable a claim to a programmed computer that determines and displays the
three-dimensional structure of a chemical compound, the disclosure must

- enable a person skilled in the art of molecular modeling to understand
and practice the underlying molecular modeling processes; and

- enable a person skilled in the art of computer programming to create a
program that directs a computer to create and display the image
representing the three-dimensional structure of the compound.

In other words, the disclosure corresponding to each aspect of the
invention must be enabling to a person skilled in each respective art.

In many instances, an applicant will describe a programmed computer by
outlining the significant elements of the programmed computer using a
functional block diagram. Office personnel should review the
specification to ensure that along with the functional block diagram the
disclosure provides information that adequately describes each "element"
in hardware or hardware and its associated software and how such
elements are interrelated. See In re Scarbrough, 500 F.2d 560, 565, 182
USPQ 298, 301-02 (CCPA 1974) ("It is not enough that a person skilled in
the art, by carrying on investigations along the line indicated in the
instant application, and by a great amount of work eventually might find
out how to make and use the instant invention. The statute requires the
application itself to inform, not to direct others to find out for
themselves (citation omitted)."); Knowlton, 481 F.2d at 1367, 178 USPQ
at 493 (disclosure must constitute more than a "sketchy explanation of
flow diagrams or a bare group of program listings together with a
reference to a proprietary computer on which they might be run"). See
also In re Gunn, 537 F.2d 1123, 1127-28, 190 USPQ 402, 405 (CCPA 1976);
In re Brandstadter, 484 F.2d 1395, 1406-07, 17 USPQ 286, 294 (CCPA
1973); and In re Ghiron, 442 F.2d 985, 991, 169 USPQ 723, 727-28 (CCPA
1971).

VI. DETERMINE WHETHER THE CLAIMED INVENTION COMPLIES WITH 35 U.S.C. 102
AND 103

As is the case for inventions in any field of technology, assessment of
a claimed computer-related invention for compliance with  35 U.S.C. 102
and 103 begins with a comparison of the claimed subject matter to what
is known in the prior art. If no differences are found between the
claimed invention and the prior art, the claimed invention lacks novelty
and is to be rejected by Office personnel under  35 U.S.C. 102. Once
distinctions are identified between the claimed invention and the prior
art, those distinctions must be assessed and resolved in light of the
knowledge possessed by a person of ordinary skill in the art. Against
this backdrop, one must determine whether the invention would have been
obvious at the time the invention was made. If not, the claimed
invention satisfies  35 U.S.C. 103. Factors and considerations dictated
by law governing  35 U.S.C. 103 apply without modification to
computer-related inventions.

If the difference between the prior art and the claimed invention is
limited to descriptive material stored on or employed by a machine,
Office personnel must determine whether the descriptive material is
functional descriptive material or nonfunctional descriptive material,
as described supra in sections IV.B.1(a) and IV. B.1(b). Functional
descriptive material is a limitation in the claim and must be considered
and addressed in assessing patentability under  35 U.S.C. 103. Thus, a
rejection of the claim as a whole under  35 U.S.C. 103 is inappropriate
unless the functional descriptive material would have been suggested by
the prior art. Nonfunctional descriptive material cannot render
nonobvious an invention that would have otherwise been obvious. Cf. In
re Gulack, 703 F.2d 1381, 1385, 217 USPQ 401, 404 (Fed. Cir. 1983) (when
descriptive material is not functionally related to the substrate, the
descriptive material will not distinguish the invention from the prior
art in terms of patentability).

Common situations involving nonfunctional descriptive material are:

- a computer-readable storage medium that differs from the prior art
solely with respect to nonfunctional descriptive material, such as music
or a literary work, encoded on the medium,

- a computer that differs from the prior art solely with respect to
nonfunctional descriptive material that cannot alter how the machine
functions (i.e., the descriptive material does not reconfigure the
computer), or

- a process that differs from the prior art only with respect to
nonfunctional descriptive material that cannot alter how the process
steps are to be performed to achieve the utility of the invention.

Thus, if the prior art suggests storing a song on a disk, merely
choosing a particular song to store on the disk would be presumed to be
well within the level of ordinary skill in the art at the time the
invention was made. The difference between the prior art and the claimed
invention is simply a rearrangement of nonfunctional descriptive
material.

VII. Clearly Communicate Findings, Conclusions and Their Bases

Once Office personnel have concluded the above analyses of the claimed
invention under all the statutory provisions, including  35 U.S.C. 101,
112, 102 and 103, they should review all the proposed rejections and
their bases to confirm their correctness. Only then should any rejection
be imposed in an Office action. The Office action should clearly
communicate the findings, conclusions and reasons which support them.

[GRAPHIC]

[GRAPHIC]

---SECTION---2106.01 Computer Programming and  35 U.S.C. 112, First
Paragraph

The requirements for sufficient disclosure of inventions involving
computer programming is the same as for all inventions sought to be
patented. Namely, there must be an adequate written description, the
original disclosure should be sufficiently enabling to allow one to make
and use the invention as claimed, and there must be presentation of a
best mode for carrying out the invention.

The following guidelines, while applicable to a wide range of arts, are
intended to provide a guide for analyzing  35 U.S.C. 112, first
paragraph, issues in applications involving computer programs, software,
firmware, or block diagram cases wherein one or more of the "block
diagram" elements are at least partially comprised of a computer
software component. It should be recognized that sufficiency of
disclosure issues in computer cases necessarily will require an inquiry
into both the sufficiency of the disclosed hardware as well as the
disclosed software due to the interrelationship and interdependence of
computer hardware and software.

WRITTEN DESCRIPTION

The function of the description requirement is to ensure that the
inventor had possession of, as of the filing date of the application
relied on, the specific subject matter later claimed by him or her; how
the specifica tion accomplishes this is not material. In re Herschler,
591 F.2d 693, 700-01, 200 USPQ 711, 717 (CCPA 1979) and further
reiterated in In re Kaslow, 707 F.2d 1366, 707 F.2d 1366, 217 USPQ 1089
(Fed. Cir. 1983). See also MPEP Section  2163 -  Section  2163.04.

BEST MODE

The purpose of the best mode requirement is to "restrain inventors from
applying for patents while at the same time concealing from the public
the preferred embodiments of their inventions which they have in fact
conceived," In re Gay, 309 F.2d 769, 772, 135 USPQ 311, 315 (CCPA 1962);
"only evidence of concealment +(accidental or intentional) is to be
considered [in judging the adequacy of a best mode disclosure]. That
evidence, in order to result in affirmance of a best mode rejection,
must tend to show that the quality of an applicant's best mode
disclosure is so poor as to effectively result in concealment." In re
Sherwood, 613 F.2d 809, 816-817, 204 USPQ 537, 544 (CCPA 1980). Also,
see White Consol. Indus.  v. Vega Servo-Control Inc., 214 USPQ 796, 824
(S.D. Mich. 1982), aff'd on related grounds, 713 F.2d 788, 218 USPQ 961
(Fed. Cir. 1983). See also MPEP Section  2165 -  Section  2165.04.

There are two factual inquiries to be made in determining whether a
specification satisfies the best mode requirement. First, there must be
a subjective determination as to whether at the time the application was
filed, the inventor knew of a best mode of practicing the invention. 
Second, if the inventor had a best mode of practicing the invention,
there must be an objective determination as to whether the best mode was
disclosed in sufficient detail to allow one skilled in the art to
practice it. Fonar Corp. v. General Electric Co., 107 F.3d 1543, 41
USPQ2d 1801, 1804 (Fed. Cir. 1997); Chemcast Corp. v. Arco Industries,
913 F.2d 923, 927-28, 16 USPQ2d 1033, 1036 (Fed. Cir. 1990).  "As a
general rule, where software constitutes part of a best mode of carrying
out an invention, description of such a best mode is satisfied by a
disclosure of the functions of the software.  This is because, normally,
writing code for such software is within the skill of the art, not
requiring undue experimentation, once its functions have been disclosed.
. . . [F]low charts or source code listings are not a requirement for
adequately disclosing the functions of software." Fonar Corp., 107 F.3d
at 1549,  41 USPQ2d at 1805 (citations omitted).

ENABLEMENT

When basing a rejection on the failure of the applicant's disclosure to
meet the enablement provisions of the first paragraph of  35 U.S.C. 112,
the examiner must establish on the record that he has a reasonable basis
for questioning the adequacy of the disclosure to enable a person of
ordinary skill in the art to make and use the claimed invention without
resorting to undue experimentation. See In re Brown, 477 F.2d 946, 177
USPQ 691 (CCPA 1973); In re Ghiron, 442 F.2d 985, 169 USPQ 723 (CCPA
1971). Once the examiner has advanced a reasonable basis for questioning
the adequacy of the disclosure, it becomes incumbent on the applicant to
rebut that challenge and factually demonstrate that his or her
application disclosure is in fact sufficient. See In re Doyle, 482 F.2d
1385, 1392, 179 USPQ 227, 232 (CCPA 1973); In re Scarbrough, 500 F.2d
560, 566, 182 USPQ 298, 302 (CCPA 1974); In re Ghiron, supra. See also
MPEP Section  2106, paragraph V.B.2 and Section  2164 - Section 
2164.08(c).

---SECTION---2106.02 Disclosure in Computer Programming Cases

To establish a reasonable basis for questioning the adequacy of a
disclosure, the examiner must present a factual analysis of a disclosure
to show that a person skilled in the art would not be able to make and
use the claimed invention without resorting to undue experimentation.

In computer applications, it is not unusual for the claimed invention to
involve two areas of prior art or more than one technology, e.g., an
appropriately programmed computer and an area of application of said
computer. White Consol. Indus., 214 USPQ at 821.  In regard to the
"skilled in the art" standard, in cases involving both the art of
computer programming, and another technology, the examiner must
recognize that the knowledge of persons skilled in both technologies is
the appropriate criteria for determining sufficiency. See In re Naquin,
398 F.2d 863, 158 USPQ 317 (CCPA 1968); In re Brown, 477 F.2d 946, 177
USPQ 691 (CCPA 1973); and White Consol. Indus. v. Vega Servo-Control,
Inc., 214 USPQ 796, 822 (S.D.Mich. 1982),   aff'd on related grounds,
713 F.2d 788, 218 USPQ 961 (Fed. Cir. 1983  ).

In a typical computer application, system components are often
represented in a "block diagram" format, i.e., a group of hollow
rectangles representing the elements of the system, functionally
labelled, and interconnected by lines. Such block diagram computer cases
may be categorized into (A) systems which include but are more
comprehensive than a computer and (B) systems wherein the block elements
are totally within the confines of a computer.

BLOCK ELEMENTS MORE COMPREHENSIVE THAN A COMPUTER

The first category of such block diagram cases involves systems which
include a computer as well as other system hardware and/or software
components. In order to meet his burden of establishing a reasonable
basis for questioning the adequacy of such disclosure, the examiner
should initiate a factual analysis of the system by focusing on each of
the individual block element components. More specifically, such an
inquiry should focus on the diverse functions attributed to each block
element as well as the teachings in the specification as to how such a
component could be implemented. If based on such an analysis, the
examiner can reasonably contend that more than routine experimentation
would be required by one of ordinary skill in the art to implement such
a component or components, that component or components should
specifically be challenged by the examiner as part of a  35 U.S.C. 112,
first paragraph rejection. Additionally, the examiner should determine
whether certain of the hardware or software components depicted as block
elements are themselves complex assemblages which have widely differing
characteristics and which must be precisely coordinated with other
complex assemblages. Under such circumstances, a reasonable basis may
exist for challenging such a functional block diagram form of
disclosure. See In re Ghiron, 442 F.2d 985, 169 USPQ 723 (CCPA 1971) and  
In re Brown, supra. Moreover, even if the applicant has cited prior art
patents or publications to demonstrate that particular block diagram
hardware or software components are old, it should not always be
considered as self-evident how such components are to be interconnected
to function in a disclosed complex manner. See In re Scarbrough, 500
F.2d 560, 566, 182 USPQ 298, 301 (CCPA 1974) and In re Forman, 463 F.2d
1125, 1129, 175 USPQ 12, 16 (CCPA 1972). Furthermore, in complex systems
including a digital computer, a microprocessor, or a complex control
unit as one of many block diagram elements, timing between various
system elements may be of the essence and without a timing chart
relating the timed sequences for each element, an unreasonable amount of
work may be required to come up with the detailed relationships an
applicant alleges that he has solved. See In re Scarbrough,  500 F.2d at
566, 182 USPQ at 302.

For example, in a block diagram disclosure of a complex claimed system
which includes a microprocessor and other system components controlled
by the microprocessor, a mere reference to a prior art, commercially
available microprocessor, without any description of the precise
operations to be performed by the microprocessor, fails to disclose how
such a microprocessor would be properly programmed to either perform any
required calculations or to coordinate the other system components in
the proper timed sequence to perform the functions disclosed and
claimed. If, in such a system, a particular program is disclosed, such a
program should be carefully reviewed to ensure that its scope is
commensurate with the scope of the functions attributed to such a
program in the claims. See In re Brown, 477 F.2d at 951, 177 USPQ at
695. If the disclosure fails to disclose any program and if more than
routine experimentation would be required of one skilled in the art to
generate such a program, the examiner clearly would have a reasonable
basis for challenging the sufficiency of such a disclosure. The amount
of experimentation that is considered routine will vary depending on the
facts and circumstances of individual cases. No exact numerical standard
has been fixed by the courts, but the "amount of required
experimentation must, however, be reasonable." White Consol. Indus., 713
F.2d at 791, 218 USPQ at 963. One court apparently found that the amount
of experimentation involved was reasonable where a skilled programmer
was able to write a general computer program, implementing an embodiment
form, within 4 hours. Hirschfield v. Banner, 462 F. Supp. 135, 142, 200
USPQ 276, 279 (D.D.C. 1978), aff'd, 615 F.2d 1368 (D.C. Cir. 1986),
cert. denied, 450 U.S. 994 (1981).  On the other hand, another court
found that, where the required period of experimentation for skilled
programmers to develop a particular program would run to 1 to 2 man
years, this would be "a clearly unreasonable requirement" (White Consol.
Indus., 713 F.2d at 791, 218  USPQ at 963).

BLOCK ELEMENTS WITHIN A COMPUTER

The second category of block diagram cases occurs most frequently in
pure data processing applications where the combination of block
elements is totally within the confines of a computer, there being no
interfacing with external apparatus other than normal input/output
devices. In some instances, it has been found that particular kinds of
block diagram disclosures were sufficient to meet the enabling
requirement of  35 U.S.C. 112, first paragraph. See In re Knowlton, 481
F.2d 1357, 178 USPQ 486 (CCPA 1973), In re Comstock, 481 F.2d 905, 178
USPQ 616 (CCPA 1973). Most significantly, however, in both the Comstock
and Knowlton cases, the decisions turned on the appellants disclosure of
(A) a reference to and reliance on an identified prior art computer
system and (B) an operative computer program for the referenced prior
art computer system. Moreover, in Knowlton the disclosure was presented
in such a detailed fashion that the individual program's steps were
specifically interrelated with the operative structural elements in the
referenced prior art computer system. The court in Knowlton indicated
that the disclosure did not merely consist of a sketchy explanation of
flow diagrams or a bare group of program listings together with a
reference to a proprietary computer in which they might be run. The
disclosure was characterized as going into considerable detail into
explaining the interrelationships between the disclosed hardware and
software elements. Under such circumstances, the Court considered the
disclosure to be concise as well as full, clear, and exact to a
sufficient degree to satisfy the literal language of  35 U.S.C. 112,
first paragraph. It must be emphasized that because of the significance
of the program listing and the reference to and reliance on an
identified prior art computer system, absent either of these items, a
block element disclosure within the confines of a computer should be
scrutinized in precisely the same manner as the first category of block
diagram cases discussed above.

Regardless of whether a disclosure involves block elements more
comprehensive than a computer or block elements totally within the
confines of a computer, the examiner, when analyzing method claims, must
recognize that the specification must be adequate to teach how to
practice the claimed method. If such practice requires a particular
apparatus, it is axiomatic that the application must therefore provide a
sufficient disclosure of that apparatus if such is not already
available. See In re Ghiron, 442 F.2d 985, 991, 169 USPQ 723, 727 (CCPA
1971) and In re Gunn, 537 F.2d 1123, 1128, 190 USPQ 402, 406 (CCPA
1976). When the examiner questions the adequacy of computer system or
computer programming disclosures, the examiner's reasons for finding the
specification to be nonenabling should be supported by the record as a
whole. In this regard, it is also essential for the examiner to
reasonably challenge evidence submitted by the applicant. For example,
in In re Naquin, supra, affiant's statement unchallenged by the
examiner, that the average computer programmer was familiar with the
subroutine necessary for performing the claimed process, was held to be
a statement of fact which rendered the examiner's rejection baseless. In
other words, unless the examiner presents a reasonable basis for
challenging the disclosure in view of the record as a whole, a  35
U.S.C. 112, first paragraph rejection in a computer system or computer
programming application will not be sustained on appeal. See In re
Naquin, supra, and   In re Morehouse, 545 F.2d 162, 165-66, 192 USPQ 29,
32 (CCPA 1976).

While no specific universally applicable rule exists for recognizing an
insufficiently disclosed application involving computer programs, an
examining guideline to generally follow is to challenge the sufficiency
of such disclosures which fail to include either the computer program
itself or a reasonably detailed flowchart which delineates the sequence
of operations the program must perform. In programming applications
software disclosure only includes a flowchart, as the complexity of
functions and the generality of the individual components of the
flowchart increase, the basis for challenging the sufficiency of such a
flowchart becomes more reasonable because the likelihood of more than
routine experimentation being required to generate a working program
from such a flowchart also increases.

	As stated earlier, once an examiner has advanced a reasonable basis or
presented evidence to question the adequacy of a computer system or
computer programming disclosure, the applicant must show that his or her
specification would enable one of ordinary skill in the art to make and
use the claimed invention without resorting to undue experimentation. In
most cases, efforts to meet this burden involve submitting affidavits,
referencing prior art patents or technical publications, arguments of
counsel, or combinations of these approaches.

AFFIDAVIT PRACTICE (37 CFR 1.132)

In computer cases, affidavits must be critically analyzed. Affidavit
practice usually initially involves analyzing the skill level and/or
qualifications of the affiant, which should be of the routineer in the
art. When an affiant's skill level is higher than that required by the
routineer for a particular application, an examiner may challenge the
affidavit since it would not be made by a routineer in the art, and
therefore would not be probative as to the amount of experimentation
required by a routineer in the art to implement the invention. An
affiant having a skill level or qualifications above that of the
routineer in the art would require less experimentation to implement the
claimed invention than that for the routineer. Similarly, an affiant
having a skill level or qualifications below that of the routineer in
the art would require more experimentation to implement the claimed
invention than that for the routineer in the art. In either situation,
the standard of the routineer in the art would not have been met.

In computer systems or programming cases, the problems with a given
affidavit, which relate to the sufficiency of disclosure issue,
generally involve affiants submitting few facts to support their
conclusions or opinions. Some affidavits may go so far as to present
conclusions on the ultimate legal question of sufficiency. In re
Brandstadter, 484 F.2d 1395  , 179 USPQ 286 (CCPA 1973) illustrates the
extent of the inquiry into the factual basis underlying an affiant's
conclusions or opinions. In Brandstadter, the invention concerned a
stored program controller (computer) programmed to control the storing,
retrieving, and forwarding of messages in a communications system. The
disclosure consisted of broadly defined block diagrams of the structure
of the invention and no flowcharts or program listings of the programs
of the controller. The Court quoted extensively from the Examiner's
Office Actions and Examiner's Answer in its opinion where it was
apparent that the Examiner consistently argued that the disclosure was
merely a broad system diagram in the form of labelled block diagrams
along with statements of a myriad of desired results. Various affidavits
were presented in which the affiants stated that all or some of the
system circuit elements in the block diagrams were either well-known in
the art or "could be constructed" by the skilled design engineer, that
the controller was "capable of being programmed" to perform the stated
functions or results desired, and that the routineer in the art "could
design or construct or was able to program" the system. The Court did
consider the affiants' statements as being some evidence on the ultimate
legal question of enablement but concluded that the statements failed in
their purpose since they recited conclusions or opinions with few facts
to support or buttress these conclusions. With reference to the lack of
a disclosed computer program or even a flowchart of the program to
control the message switching system, the record contained no evidence
as to the number of programmers needed, the number of man-hours and the
level of skill of the programmers to produce the program required to
practice the invention.

It should be noted also that it is not opinion evidence directed to the
ultimate legal question of enablement, but rather factual evidence
directed to the amount of time and effort and level of knowledge
required for the practice of the invention from the disclosure alone
which can be expected to rebut a prima facie case of nonenablement. See
Hirschfield, 462 F. Supp. at 143, 200 USPQ at 281. It has also been held
that where an inventor described the problem to be solved to an affiant,
thus enabling the affiant to generate a computer program to solve the
problem, such an affidavit failed to demonstrate that the application
alone would have taught a person of ordinary skill in the art how to
make and use the claimed invention.  See In re Brown, 477 F.2d at 951,
177 USPQ at 695. The Court indicated that it was not factually
established that the applicant did not convey to the affiant vital and
additional information in their several meetings in addition to that set
out in the application. Also of significance for an affidavit to be
relevant to the determination of enablement is that it must be probative
of the level of skill of the routineer in the art as of the time the
applicant filed his application. See In re Gunn, 537 F.2d at 1128, 190
USPQ at 406. In this case, each of the affiants stated what was known at
the time he executed the affidavit, and not what was known at the time
the applicant filed his application.

REFERENCING PRIOR ART DOCUMENTS

Earlier, it had been discussed that citing in the specification the
commercial availability of an identified prior art computer system is
very pertinent to the issue of enablement. But in some cases, this
approach may not be sufficient to meet the applicant's burden. Merely
citing in an affidavit extracts from technical publications in order to
satisfy the enablement requirement is not sufficient if it is not made
clear that a person skilled in the art would know which, or what parts,
of the cited circuits could be used to construct the claimed device or
how they could be interconnected to act in combination to produce the
required results. See In re Forman, 463 F.2d at 1129, 175 USPQ at 16.
This analysis would appear to be less critical where the circuits
comprising applicant's system are essentially standard components
comprising an identified prior art computer system and a standard device
attached thereto.

Prior art patents are often relied on by applicants to show the state of
the art for purposes of enablement. However, these patents must have an
issue date earlier than the effective filing date of the application
under consideration. See In re Budnick, 537 F.2d 535, 538, 190 USPQ 422,
424 (CCPA 1976). An analogous point was made in In re Gunn, supra, where
the court indicated that patents issued after the filing date of the
applicant's application are not evidence of subject matter known to any
person skilled in the art since their subject matter may have been known
only to the patentees and the Patent and Trademark Office.

Merely citing prior art patents to demonstrate that the challenged
components are old may not be sufficient proof since, even if each of
the enumerated devices or labelled blocks in a block diagram disclosure
were old, per se, this would not make it self-evident how each would be
interconnected to function in a disclosed complex combination manner.
Therefore, the specification in effect must set forth the integration of
the prior art; otherwise, it is likely that undue experimentation, or
more than routine experimentation would be required to implement the
claimed invention. See In re Scarbrough, 560 F.2d at 565, 182 USPQ at
301. The court also noted that any cited patents which are used by the
applicant to demonstrate that particular box diagram hardware or
software components are old must be analyzed as to whether such patents
are germane to the instant invention and as to whether such components
provide better detail of disclosure as to such components than an
applicant's own disclosure. Also any patent or publication cited to
provide evidence that a particular programming technique is well-known
in the programming art does not demonstrate that one of ordinary skill
in the art could make and use correspondingly disclosed programming
techniques unless both programming techniques are of approximately the
same degree or complexity. See In re Knowlton, 500 F.2d 566, 572, 183
USPQ 33, 37 (CCPA 1974).

ARGUMENTS OF COUNSEL

Arguments of counsel may be effective in establishing that an examiner
has not properly met his or her burden or has otherwise erred in his or
her position. In these situations, an examiner may have failed to set
forth any basis for questioning the adequacy of the disclosure or may
not have considered the whole specification, including the drawings and
the written description. However, it must be emphasized that arguments
of counsel alone cannot take the place of evidence in the record once an
examiner has advanced a reasonable basis for questioning the disclosure.
See In re Budnick, 537 F.2d at 538, 190 USPQ at 424; In re Schulze, 346
F.2d 600, 145 USPQ 716 (CCPA 1965); and In re Cole, 326 F.2d 769, 140
USPQ 230 (CCPA 1964). For example, in a case where the record consisted
substantially of arguments and opinions of applicant's attorney, the
court indicated that factual affidavits could have provided important
evidence on the issue of enablement. See In re Knowlton, 500 F.2d at
572, 183 USPQ at 37, and In re Wiseman, 596 F.2d 1019, 201 USPQ 658
(CCPA 1979).

---SECTION---2107 General Principles Governing Utility Rejections

35 U.S.C. 101 Inventions patentable

Whoever invents or discovers any new and useful process, machine,
manufacture, or composition of matter, or any new and useful improvement
thereof may obtain a patent therefor, subject to the conditions and
requirements of this title.

See MPEP Section  706.03(a)(1) for guidelines for the examination of
applications for compliance with the utility requirement of  35 U.S.C.
101.

The Office must examine each application to ensure compliance with the
"useful invention" or utility requirement of  35 U.S.C. 101. In
discharging this obligation, however, Office personnel must keep in mind
several general principles that control application of the utility
requirement. As interpreted by the Federal courts,  35 U.S.C. 101 has
two purposes. First,  35 U.S.C. 101 defines which categories of
inventions are eligible for patent protection. An invention that is not
a machine, an article of manufacture, a composition or a process cannot
be patented. See Diamond v. Chakrabarty, 447 U.S. 303, 206 USPQ 193
(1980); Diamond v. Diehr, 450 U.S. 175, 209 USPQ 1 (1981). Second,  35
U.S.C. 101 serves to ensure that patents are granted on only those
inventions that are "useful." This second purpose has a Constitutional
footing - Article I, Section 8 of the Constitution authorizes Congress
to provide exclusive rights to inventors to promote the "useful arts."
See Carl Zeiss Stiftung v. Renishaw PLC, 945 F.2d 1173, 20 USPQ2d 1094
(Fed. Cir. 1991). Thus, to satisfy the requirements of  35 U.S.C. 101,
an applicant must claim an invention that is statutory subject matter
and must show that the claimed invention is "useful" for some purpose
either explicitly or implicitly. Application of this latter element of 
35 U.S.C. 101 is the focus of these guidelines.

Deficiencies under the "useful invention" requirement of  35 U.S.C. 101
will arise in one of two forms. The first is where it is not apparent
why the applicant believes the invention to be "useful." This can occur
when an applicant fails to identify any specific utility for the
invention or fails to disclose enough information about the invention to
make its usefulness immediately apparent to those familiar with the
technological field of the invention. Brenner v. Manson, 383 U.S. 519,
148 USPQ 689 (1966); In re Ziegler, 992 F.2d 1197, 26 USPQ2d 1600 (Fed.
Cir. 1993). The second type of deficiency arises in the rare instance
where an assertion of specific utility for the invention made by an
applicant is not credible.

I. "REAL WORLD VALUE" REQUIREMENT

To satisfy  35 U.S.C. 101, an invention must be "useful." Courts have
recognized that the term "useful" used with reference to the utility
requirement can be a difficult term to define. Brenner v. Manson, 383
U.S. 519, 529, 148 USPQ 689, 693 (1966) (simple everyday word like
"useful" can be "pregnant with ambiguity when applied to the facts of
life."). Where an applicant has set forth a specific utility, courts
have been reluctant to uphold a rejection under  35 U.S.C. 101 solely on
the basis that the applicant's opinion as to the nature of the specific
utility was inaccurate. For example, in Nelson v. Bowler, 626 F.2d 853,
206 USPQ 881 (CCPA 1980), the court reversed a finding by the Office
that the applicant had not set forth a "practical" utility under  35
U.S.C. 101 despite the fact that the applicant asserted that the
composition was "useful" in a particular pharmaceutical application and
provided evidence to support that assertion. Courts have used the labels
"practical utility" or "specific utility" to refer to this aspect of the
"useful invention" requirement of  35 U.S.C. 101. The Court of Customs
and Patent Appeals has stated:

Practical utility is a shorthand way of attributing "real-world" value
to claimed subject matter. In other words, one skilled in the art can
use a claimed discovery in a manner which provides some immediate
benefit to the public. Nelson v. Bowler, 626 F.2d 853, 856, 206 USPQ
881, 883 (CCPA 1980).

Practical considerations require the Office to rely on the inventor's
understanding of his or her invention in determining whether and in what
regard an invention is believed to be "useful." Because of this, Office
personnel should focus on and be receptive to specific assertions made
by the applicant that an invention is "useful" for a particular reason.
Office personnel should distinguish between situations where an
applicant has disclosed a specific use for or application of the
invention and situations where the applicant merely indicates that the
invention may prove useful without identifying with specificity why it
is considered useful. For example, indicating that a compound may be
useful in treating unspecified disorders, or that the compound has
"useful biological" properties, would not be sufficient to define a
specific utility for the compound. Contrast the situation where an
applicant discloses a specific biological activity and reasonably
correlates that activity to a disease condition. Assertions falling
within the latter category are sufficient to identify a specific utility
for the invention. Assertions that fall in the former category are
insufficient to define a specific utility for the invention, especially
if the assertion takes the form of a general statement that makes it
clear that a "useful" invention may arise from what has been disclosed
by the applicant. Knapp v. Anderson, 477 F.2d 588, 177 USPQ 688 (CCPA
1973).

Some confusion can result when one attempts to label certain types of
inventions as not being capable of having a specific utility based on
the setting in which the invention is to be used. One example are
inventions to be used in a research or laboratory setting. Many research
tools such as gas chromatographs, screening assays, and nucleotide
sequencing techniques have a clear, specific and unquestionable utility
(e.g., they are useful in analyzing compounds). An assessment that
focuses on whether an invention is useful only in a research setting
thus does not address whether the specific invention is in fact "useful"
in a patent sense. Instead, Office personnel must distinguish between
inventions that have a specifically identified utility and inventions
whose specific utility requires further research to identify or
reasonably confirm. Labels such as "research tool," "intermediate" or
"for research purposes" are not helpful in determining if an applicant
has identified a specific utility for the invention.

Office personnel also must be careful not to interpret the phrase
"immediate benefit to the public" or similar formulations in other cases
to mean that products or services based on the claimed invention must be
"currently available" to the public in order to satisfy the utility
requirement. See, e.g., Brenner v. Manson, 383 U.S. 519, 534-35, 148
USPQ 689, 695 (1966). Rather, any reasonable use that an applicant has
identified for the invention that can be viewed as providing a public
benefit should be accepted as sufficient, at least with regard to
defining a "specific" utility.

II. WHOLLY INOPERATIVE INVENTIONS; "INCREDIBLE" UTILITY

An invention that is "inoperative" (i.e., it does not operate to produce
the results claimed by the patent applicant) is not a "useful" invention
in the meaning of the patent law.  See, e.g., Newman v. Quigg, 877 F.2d
1575, 1581, 11 USPQ2d 1340, 1345 (Fed. Cir. 1989); In re Harwood, 390
F.2d 985, 989, 156 USPQ 673, 676 (CCPA 1968) ("An inoperative invention,
of course, does not satisfy the requirement of  35 U.S.C. 101 that an
invention be useful."). However, as the Federal Circuit has stated,
"[t]o violate [35 U.S.C.] 101 the claimed device must be totally
incapable of achieving a useful result." Brooktree Corp. v. Advanced
Micro Devices, Inc., 977 F.2d 1555, 1571, 24 USPQ2d 1401, 1412 (Fed.
Cir. 1992) (emphasis added). See also E.I. du Pont De Nemours and Co. v.
Berkley and Co., 620 F.2d 1247, 1260 n.17, 205 USPQ 1, 10 n.17 (8th Cir.
1980) ("A small degree of utility is sufficient . . . The claimed
invention must only be capable of performing some beneficial function .
. . An invention does not lack utility merely because the particular
embodiment disclosed in the patent lacks perfection or performs crudely
. . . A commercially successful product is not required . . . Nor is it
essential that the invention accomplish all its intended functions . . .
or operate under all conditions . . . partial success being sufficient
to demonstrate patentable utility . . . In short, the defense of
non-utility cannot be sustained without proof of total incapacity." If
an invention is only partially successful in achieving a useful result,
a rejection of the claimed invention as a whole based on a lack of
utility is not appropriate. See In re Brana, 51 F.3d 1560, 34 USPQ2d
1436 (Fed. Cir. 1995); In re Gardner, 475 F.2d 1389, 177 USPQ 396
(CCPA), reh'g denied, 480 F.2d 879 (CCPA 1973); In re Marzocchi, 439
F.2d 220, 169 USPQ 367 (CCPA 1971).

Situations where an invention is found to be "inoperative" and therefore
lacking in utility are rare, and rejections maintained solely on this
ground by a Federal court even rarer. In many of these cases, the
utility asserted by the applicant was thought to be "incredible in the
light of the knowledge of the art, or factually misleading" when
initially considered by the Office. In re Citron, 325 F.2d 248, 253, 139
USPQ 516, 520 (CCPA 1963).  Other cases suggest that on initial
evaluation, the Office considered the asserted utility to be
inconsistent with known scientific principles or "speculative at best"
as to whether attributes of the invention necessary to impart the
asserted utility were actually present in the invention. In re Sichert,
566 F.2d 1154, 196 USPQ 209 (CCPA 1977). However cast, the underlying
finding by the court in these cases was that, based on the factual
record of the case, it was clear that the invention could and did not
work as the inventor claimed it did. Indeed, the use of many labels to
describe a single problem (e.g., an assertion regarding utility that is
false) has led to some of the confusion that exists today with regard to
a rejection based on the "utility" requirement. Examples of such cases
include: an invention asserted to change the taste of food using a
magnetic field (Fregeau v. Mossinghoff, 776 F.2d 1034, 227 USPQ 848
(Fed. Cir. 1985)), a perpetual motion machine (Newman v. Quigg, 877 F.2d
1575, 11 USPQ2d 1340 (Fed. Cir. 1989)), a flying machine operating on
"flapping or flutter function" (In re Houghton, 433 F.2d 820, 167 USPQ
687 (CCPA 1970)), a method for increasing the energy output of fossil
fuels upon combustion through exposure to a magnetic field (In re
Ruskin, 354 F.2d 395, 148 USPQ 221 (CCPA 1966)), uncharacterized
compositions for curing a wide array of cancers (In re Citron, 325 F.2d
248, 139 USPQ 516 (CCPA 1963)), a method of controlling the aging
process (In re Eltgroth, 419 F.2d 918, 164 USPQ 221 (CCPA 1970)), and a
method of restoring hair growth (In re Ferens, 417 F.2d 1072, 163 USPQ
609 (CCPA 1969)). Thus, in view of the rare nature of such cases, Office
personnel should not label an asserted utility "incredible,"
"speculative" or otherwise unless it is clear that a rejection based on
"lack of utility" is proper.

III. THERAPEUTIC OR PHARMACOLOGICAL UTILITY

Inventions asserted to have utility in the treatment of human or animal
disorders are subject to the same legal requirements for utility as
inventions in any other field of technology. In re Chilowsky, 229 F.2d
457, 461-2, 108 USPQ 321, 325 (CCPA 1956) ("There appears to be no basis
in the statutes or decisions for requiring any more conclusive evidence
of operativeness in one type of case than another. The character and
amount of evidence needed may vary, depending on whether the alleged
operation described in the application appears to accord with or to
contravene established scientific principles or to depend upon
principles alleged but not generally recognized, but the degree of
certainty as to the ultimate fact of operativeness or inoperativeness
should be the same in all cases"); In re Gazave, 379 F.2d 973, 978, 154
USPQ 92, 96 (CCPA 1967) ("Thus, in the usual case where the mode of
operation alleged can be readily understood and conforms to the known
laws of physics and chemistry, operativeness is not questioned, and no
further evidence is required."). As such, pharmacological or therapeutic
inventions that provide any "immediate benefit to the public" satisfy 
35 U.S.C. 101. The utility being asserted in Nelson related to a
compound with pharmacological utility. Nelson v. Bowler, 626 F.2d 853,
856, 206 USPQ 881, 883 (CCPA 1980). Office personnel should rely on
Nelson and other cases as providing general guidance when evaluating the
utility of an invention that is based on any therapeutic, prophylactic,
or pharmacological activities of that invention.

Courts have repeatedly found that the mere identification of a
pharmacological activity of a compound that is relevant to an asserted
pharmacological use provides an "immediate benefit to the public" and
thus satisfies the utility requirement. As the Court of Customs and
Patent Appeals held in Nelson v. Bowler:

Knowledge of the pharmacological activity of any compound is obviously
beneficial to the public. It is inherently faster and easier to combat
illnesses and alleviate symptoms when the medical profession is armed
with an arsenal of chemicals having known pharmacological activities.
Since it is crucial to provide researchers with an incentive to disclose
pharmacological activities in as many compounds as possible, we conclude
that adequate proof of any such activity constitutes a showing of
practical utility. Nelson v. Bowler, 626 F.2d 853, 856, 206 USPQ 881,
883 (CCPA 1980).

In Nelson v. Bowler, the court addressed the practical utility
requirement in the context of an interference proceeding. Bowler
challenged the patentability of the invention claimed by Nelson on the
basis that Nelson had failed to sufficiently and persuasively disclose
in his application a practical utility for the invention. Nelson had
developed and claimed a class of synthetic prostaglandins modeled on
naturally occurring prostaglandins. Naturally occurring prostaglandins
are bioactive compounds that, at the time of Nelson's application, had a
recognized value in pharmacology (e.g., the stimulation of uterine
smooth muscle which resulted in labor induction or abortion, the ability
to raise or lower blood pressure, etc.). To support the utility he
identified in his disclosure, Nelson included in his application the
results of tests demonstrating the bioactivity of his new substituted
prostaglandins relative to the bioactivity of naturally occurring
prostaglandins. The court concluded that Nelson had satisfied the
practical utility requirement in identifying the synthetic
prostaglandins as pharmacologically active compounds. In reaching this
conclusion, the court considered and rejected arguments advanced by
Bowler that attacked the evidentiary basis for Nelson's assertions that
the compounds were pharmacologically active.

In In re Jolles, 628 F.2d 1322, 206 USPQ 885 (CCPA 1980), an inventor
claimed protection for pharmaceutical compositions for treating
leukemia. The active ingredient in the compositions was a structural
analog to a known anticancer agent. The applicant provided evidence
showing that the claimed analogs had the same general pharmaceutical
activity as the known anticancer agents. The court reversed the Board's
finding that the asserted pharmaceutical utility was "incredible,"
pointing to the evidence that showed the relevant pharmacological
activity.

In Cross v. Iizuka, 753 F.2d 1040, 224 USPQ 739 (Fed. Cir. 1985), the
Federal Circuit affirmed a finding by the Board of Patent Appeals and
Interferences that a pharmacological utility had been disclosed in the
application of one party to an interference proceeding. The invention
that was the subject of the interference count was a chemical compound
used for treating blood disorders. Cross had challenged the evidence in
Iizuka's specification that supported the claimed utility. However, the
Federal Circuit relied extensively on Nelson v. Bowler in finding that
Iizuka's application had sufficiently disclosed a pharmacological
utility for the compounds. It distinguished the case from cases where
only a generalized "nebulous" expression, such as "biological
properties," had been disclosed in a specification. Such statements, the
court held, "convey little explicit indication regarding the utility of
a compound." Cross, 753 F.2d at 1048, 224 USPQ at 745 (citing In re
Kirk, 376 F.2d 936, 941, 153 USPQ 48, 52 (CCPA 1967)).

Similarly, courts have found utility for therapeutic inventions despite
the fact that an applicant is at a very early stage in the development
of a pharmaceutical product or therapeutic regimen based on a claimed
pharmacological or bioactive compound or composition. The Federal
Circuit, in Cross v. Iizuka, 753 F.2d 1040, 1051, 224 USPQ 739, 747-48
(Fed. Cir. 1985), commented on the significance of data from in vitro
testing that showed pharmacological activity:

We perceive no insurmountable difficulty, under appropriate
circumstances, in finding that the first link in the screening chain, in
vitro testing, may establish a practical utility for the compound in
question. Successful in vitro testing will marshal resources and direct
the expenditure of effort to further in vivo testing of the most potent
compounds, thereby providing an immediate benefit to the public,
analogous to the benefit provided by the showing of an in vivo utility.

Recently, the Federal Circuit reiterated that therapeutic utility
sufficient under the patent laws is not to be confused with the
requirements of the FDA with regard to safety and efficacy of drugs to
marketed in the United States.

FDA approval, however, is not a prerequisite for finding a compound
useful within the meaning of the patent laws. Scott [v. Finney], 34 F.3d
1058, 1063, 32 USPQ2d 1115, 1120 [(Fed.Cir. 1994)]. Usefulness in patent
law, and in particular in the context of pharmaceutical inventions,
necessarily includes the expectation of further research and
development. The stage at which an invention in this field becomes
useful is well before it is ready to be administered to humans. Were we
to require Phase II testing in order to prove utility, the associated
costs would prevent many companies from obtaining patent protection on
promising new inventions, thereby eliminating an incentive to pursue,
through research and development, potential cures in many crucial areas
such as the treatment of cancer.

In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. 1995). Accordingly,
Office personnel should not construe  35 U.S.C. 101, under the logic of
"practical" utility or otherwise, to require that an applicant
demonstrate that a therapeutic agent based on a claimed invention is a
safe or fully effective drug for humans. See, e.g., In re Sichert, 566
F.2d 1154, 196 USPQ 209 (CCPA 1977); In re Hartop, 311 F.2d 249, 135
USPQ 419 (CCPA 1962); In re Anthony, 414 F.2d 1383, 162 USPQ 594 (CCPA
1969); In re Watson, 517 F.2d 465, 186 USPQ 11 (CCPA 1975).

These general principles are equally applicable to situations where an
applicant has claimed a process for treating a human or animal disorder.
In such cases, the asserted utility is usually clear - the invention is
asserted to be useful in treating the particular disorder. If the
asserted utility is credible, there is no basis to challenge such a
claim on the basis that it lacks utility under  35 U.S.C. 101.

IV. RELATIONSHIP BETWEEN 35 U.S.C. 112, FIRST PARAGRAPH, AND 35 U.S.C.
101

A deficiency under  35 U.S.C. 101 also creates a deficiency under  35
U.S.C. 112, first paragraph. See In re Brana, 51 F.3d 1560, 34 USPQ2d
1436 (Fed. Cir. 1995); In re Jolles, 628 F.2d 1322, 1326 n.10, 206 USPQ
885, 889 n.11 (CCPA 1980); In re Fouche, 439 F.2d 1237, 1243, 169 USPQ
429, 434 (CCPA 1971) ("If such compositions are in fact useless,
appellant's specification cannot have taught how to use them."). Courts
have also cast the  35 U.S.C. 101/ 35 U.S.C. 112 relationship such that 
35 U.S.C. 112 presupposes compliance with  35 U.S.C. 101 compliance. See
In re Ziegler, 992 F.2d 1197, 1200-1201, 26 USPQ2d 1600, 1603 (Fed. Cir.
1993) ("The how to use prong of section 112 incorporates as a matter of
law the requirement of  35 U.S.C. 101 that the specification disclose as
a matter of fact a practical utility for the invention. ... If the
application fails as a matter of fact to satisfy 35 U.S.C. Section  101,
then the application also fails as a matter of law to enable one of
ordinary skill in the art to use the invention under 35 U.S.C. Section 
112."); In re Kirk, 376 F.2d 936, 942, 153 USPQ 48, 53 (CCPA 1967)
("Necessarily, compliance with Section  112 requires a description of
how to use presently useful inventions, otherwise an applicant would
anomalously be required to teach how to use a useless invention."). For
example, the Federal Circuit recently noted, "[o]bviously, if a claimed
invention does not have utility, the specification cannot enable one to
use it." In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. 1995). As
such, a rejection properly imposed under  35 U.S.C. 101 should be
accompanied with a rejection under  35 U.S.C. 112, first paragraph. It
is equally clear that a rejection based on "lack of utility," whether
grounded upon  35 U.S.C. 101 or  35 U.S.C. 112, first paragraph, rests
on the same basis (i.e., the asserted utility is not credible). To avoid
confusion, any rejection that is imposed on the basis of  35 U.S.C. 101
should be accompanied by a rejection based on  35 U.S.C. 112, first
paragraph. The  35 U.S.C. 112, first paragraph, rejection should be set
out as a separate rejection that incorporates by reference the factual
basis and conclusions set forth in the  35 U.S.C. 101 rejection. The  35
U.S.C. 112, first paragraph, rejection should indicate that because the
invention as claimed does not have utility, a person skilled in the art
would not be able to use the invention as claimed, and as such, the
claim is defective under  35 U.S.C. 112, first paragraph. A  35 U.S.C.
112, first paragraph, rejection should not be imposed or maintained
unless an appropriate basis exists for imposing a rejection under  35
U.S.C. 101. In other words, Office personnel should not impose a  35
U.S.C. 112, first paragraph, rejection grounded on a "lack of utility"
basis unless a  35 U.S.C. 101 rejection is proper. In particular, the
factual showing needed to impose a rejection under  35 U.S.C. 101 must
be provided if a rejection under  35 U.S.C. 112, first paragraph, is to
be imposed on "lack of utility" grounds.

It is important to recognize that  35 U.S.C. 112, first paragraph,
addresses matters other than those related to the question of whether or
not an invention lacks utility. These matters include whether the claims
are fully supported by the disclosure (In re Vaeck, 947 F.2d 488, 495,
20 USPQ2d 1438, 1444 (Fed. Cir. 1991)), whether the applicant has
provided an enabling disclosure of the claimed subject matter (In re
Wright, 999 F.2d 1557, 1561-1562, 27 USPQ2d 1510, 1513 (Fed. Cir.
1993)), whether the applicant has provided an adequate written
description of the invention and whether the applicant has disclosed the
best mode of practicing the claimed invention (Chemcast Corp. v. Arco
Indus. Corp., 913 F.2d 923, 927-928, 16 USPQ2d 1033, 1036-1037 (Fed.
Cir. 1990). See also Transco Products Inc. v. Performance Contracting
Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994); Glaxo Inc. v.
Novopharm Ltd. 52 F.3d 1043, 34 USPQ2d 1565 (Fed. Cir. 1995)). The fact
that an applicant has disclosed a specific utility for an invention and
provided a credible basis supporting that specific utility does not
provide a basis for concluding that the claims comply with all the
requirements of 35 U.S.C. 112, first paragraph. For example, if an
applicant has claimed a process of treating a certain disease condition
with a certain compound and provided a credible basis for asserting that
the compound is useful in that regard, but to actually practice the
invention as claimed a person skilled in the relevant art would have to
engage in an undue amount of experimentation, the claim may be defective
under  35 U.S.C. 112, but not  35 U.S.C. 101. To avoid confusion during
examination, any rejection under  35 U.S.C. 112, first paragraph, based
on grounds other than "lack of utility" should be imposed separately
from any rejection imposed due to "lack of utility" under  35 U.S.C. 101
and  35 U.S.C. 112, first paragraph.

---SECTION---2107.01 Procedural Considerations Related to Rejections for
Lack of Utility

I. THE CLAIMED INVENTION IS THE FOCUS OF THE UTILITY REQUIREMENT

The claimed invention is the focus of the assessment of whether an
applicant has satisfied the utility requirement. Each claim (i.e., each
"invention"), therefore, must be evaluated on its own merits for
compliance with all statutory requirements. Generally speaking, however,
a dependent claim will define an invention that has utility if the claim
from which it depends has defined an invention having utility. An
exception to this general rule is where the utility specified for the
invention defined in a dependent claim differs from that indicated for
the invention defined in the independent claim from which the dependent
claim depends. Where an applicant has established utility for a species
that falls within a identified genus of compounds, and presents a
generic claim covering the genus, as a general matter, that claim should
be treated as being sufficient under  35 U.S.C. 101. Only where it can
be established that other species clearly encompassed by the claim do
not have utility should a rejection be imposed on the generic claim. In
such cases, the applicant should be encouraged to amend the generic
claim so as to exclude the species that lack utility. A claim that
raises this question is likely to be deficient under  35 U.S.C. 112,
second paragraph, in terms of accurately defining the genus to encompass
species that are sufficiently similar to constitute the genus.

It is common and sensible for an applicant to identify several specific
utilities for an invention, particularly where the invention is a
product (e.g., a machine, an article of manufacture or a composition of
matter). However, regardless of the category of invention that is
claimed (e.g., product or process), an applicant need only make one
credible assertion of specific utility for the claimed invention to
satisfy  35 U.S.C. 101 and  35 U.S.C. 112; additional statements of
utility, even if not "credible," do not render the claimed invention
lacking in utility. See, e.g., Raytheon v. Roper, 724 F.2d 951, 958, 220
USPQ 592, 598 (Fed. Cir. 1983), cert. denied, 469 U.S. 835 (1984) ("When
a properly claimed invention meets at least one stated objective,
utility under  35 U.S.C. 101 is clearly shown." );   In re Gottlieb, 328
F.2d 1016, 1019, 140 USPQ 665, 668 (CCPA 1964) ("Having found that the
antibiotic is useful for some purpose, it becomes unnecessary to decide
whether it is in fact useful for the other purposes `indicated' in the
specification as possibly useful." ); In re Malachowski, 530 F.2d 1402,
189 USPQ 432 (CCPA 1976); Hoffman v. Klaus, 9 USPQ2d 1657 (Bd. Pat. App.
& Inter. 1988). Thus, if applicant makes one credible assertion of
utility, utility for the claimed invention as a whole is established.

Statements made by the applicant in the specification or incident to
prosecution of the application before the Office cannot, standing alone,
be the basis for a lack of utility rejection under  35 U.S.C. 101 or  35
U.S.C. 112. Tol-O-Matic, Inc. v. Proma Produkt-Und Mktg. Gesellschaft
m.b.h., 945 F.2d 1546, 1553, 20 USPQ2d 1332, 1338 (Fed. Cir. 1991) (It
is not required that a particular characteristic set forth in the
prosecution history be achieved in order to satisfy  35 U.S.C. 101.). An
applicant may include statements in the specification whose technical
accuracy cannot be easily confirmed if those statements are not
necessary to support the patentability of an invention with regard to
any statutory basis. Thus, the Office should not require an applicant to
strike nonessential statements relating to utility from a patent
disclosure, regardless of the technical accuracy of the statement or
assertion it presents. Office personnel should also be especially
careful not to read into a claim unclaimed results, limitations or
embodiments of an invention. See Carl Zeiss Stiftung v. Renishaw PLC,
945 F.2d 1173, 20 USPQ2d 1094 (Fed. Cir. 1991); In re Krimmel, 292 F.2d
948, 130 USPQ 215 (CCPA 1961). Doing so can inappropriately change the
relationship of an asserted utility to the claimed invention and raise
issues not relevant to examination of that claim.

II. IS THERE AN ASSERTED OR WELL-ESTABLISHED UTILITY FOR THE CLAIMED
INVENTION?

Upon initial examination, the examiner should review the specification
to determine if there are any statements asserting that the claimed
invention is useful for any particular purpose. A complete disclosure
should include a statement which identifies a specific utility for the
invention.

A. An Asserted Utility Must Be Specific, Not General

A statement of specific utility should fully and clearly explain why the
applicant believes the invention is useful. Such statements will usually
explain the purpose of or how the invention may be used (e.g., a
compound is believed to be useful in the treatment of a particular
disorder). Regardless of the form of statement of specific utility, it
must enable one ordinarily skilled in the art to understand why the
applicant believes the claimed invention is useful.

Except where an invention has a well-established utility, the failure of
an applicant to specifically identify why an invention is believed to be
useful renders the claimed invention deficient under  35 U.S.C. 101 and 
35 U.S.C. 112, first paragraph. In such cases, the applicant has failed
to identify a "specific utility" for the claimed invention. For example,
a statement that a composition has an unspecified "biological activity"
or that does not explain why a composition with that activity is
believed to be useful fails to set forth a "specific utility." Brenner
v. Manson, 383 US 519, 148 USPQ 689 (1966) (general assertion of
similarities to known compounds known to be useful without sufficient
corresponding explanation why claimed compounds are believed to be
similarly useful insufficient under  35 U.S.C. 101); In re Ziegler, 992
F.2d 1197, 1201, 26 USPQ2d 1600, 1604 (Fed. Cir. 1993) (disclosure that
composition is "plastic-like" and can form "films" not sufficient to
identify specific utility for invention); In re Kirk, 376 F.2d 936, 153
USPQ 48 (CCPA 1967) (indication that compound is "biologically active"
or has "biological properties" insufficient standing alone). See also In
re Joly, 376 F.2d 906, 153 USPQ 45 (CCPA 1967); Kawai v. Metlesics, 480
F.2d 880, 890, 178 USPQ 158, 165 (CCPA 1973) (contrasting description of
invention as sedative which did suggest specific utility to general
suggestion of "pharmacological effects on the central nervous system"
which did not). In contrast, a disclosure that identifies a particular
biological activity of a compound and explains how that activity can be
utilized in a particular therapeutic application of the compound does
contain an assertion of specific utility for the invention.

Situations where an applicant either fails to indicate why an invention
is considered useful, or where the applicant inaccurately describes the
utility should rarely arise. One reason for this is that applicants are
required to disclose the best mode known to them of practicing the
invention at the time they file their application. An applicant who
omits a description of the specific utility of the invention, or who
incompletely describes that utility, may encounter problems with respect
to the best mode requirement of  35 U.S.C. 112, first paragraph.

B. No Statement of Utility for the Claimed Invention in the
Specification Does Not Per Se Negate Utility

Occasionally, an applicant will not explicitly state in the
specification or otherwise assert a specific utility for the claimed
invention. If no statements can be found asserting a specific utility
for the claimed invention in the specification, Office personnel should
determine if the claimed invention has a well-established utility. A
well-established utility is one that would be immediately apparent to a
person of ordinary skill based upon disclosed features or
characteristics of the invention, or statements made by the applicant in
the written description of the invention. If an invention has a well-
established utility, rejections under  35 U.S.C. 101 and  35 U.S.C. 112,
first paragraph, based on lack of utility should not be imposed. In re
Folkers, 344 F.2d 970, 145 USPQ 390 (CCPA 1965). For example, if an
application teaches the cloning and characterization of the nucleotide
sequence of a well-known protein such as insulin, and those skilled in
the art at the time of filing knew that insulin had a well-established
use, it would be improper to reject the claimed invention as lacking
utility solely because of the omitted statement of specific utility.

If a person of ordinary skill would not immediately recognize a specific
utility for the claimed invention (i.e., why it would be useful) based
on the characteristics of the invention or statements made by the
applicant, the Examiner should reject the application under  35 U.S.C.
101 and under  35 U.S.C. 112, first paragraph, as failing to identify a
specific utility for the claimed invention. The rejection should clearly
indicate that the basis of the rejection is that the application fails
to identify a specific utility for the invention. The rejection should
also specify that the applicant must reply by indicating why the
invention is believed useful and where support for any subsequently
asserted utility can be found in the specification as filed.

If the applicant subsequently indicates why the invention is useful,
Office personnel should review that assertion according to the standards
articulated below for review of the credibility of an asserted utility.

III. EVALUATING THE CREDIBILITY OF AN ASSERTED UTILITY

A. An Asserted Utility Creates a Presumption of Utility

In most cases, an applicant's assertion of utility creates a presumption
of utility that will be sufficient to satisfy the utility requirement of 
35 U.S.C. 101. See, e.g., In re Jolles, 628 F.2d 1322, 206 USPQ 885
(CCPA 1980); In re Irons, 340 F.2d 974, 144 USPQ 351 (CCPA 1965); In re
Langer, 503 F.2d 1380, 183 USPQ 288 (CCPA 1974); In re Sichert, 566 F.2d
1154, 1159, 196 USPQ 209, 212-13 (CCPA 1977). As the Court of Customs
and Patent Appeals stated in In re Langer:

As a matter of Patent Office practice, a specification which contains a
disclosure of utility which corresponds in scope to the subject matter
sought to be patented must be taken as sufficient to satisfy the utility
requirement of Section  101 for the entire claimed subject matter  
unless there is a reason for one skilled in the art to question the
objective truth of the statement of utility or its scope. In re Langer,
503 F.2d at 1391, 183 USPQ at 297 (emphasis in original). The "Langer"
test for utility has been used by both the Federal Circuit and the Court
of Customs and Patent Appeals in evaluation of rejections under  35
U.S.C. 112, first paragraph, where the rejection is based on a
deficiency under  35 U.S.C. 101.  In In re Brana, 51 F.3d 1560, 34
USPQ2d 1436 (Fed. Cir. 1995), the Federal Circuit explicitly adopted the
Court of Customs and Patent Appeals's formulation of the "Langer"
standard for  35 U.S.C. 112, first paragraph rejections, as it was
expressed in a slightly reworded format in In re Marzocchi, 439 F.2d
220, 223, 169 USPQ 367, 369 (CCPA 1971), namely:

[A] specification disclosure which contains a teaching of the manner and
process of making and using the invention in terms which correspond in
scope to those used in describing and defining the subject matter sought
to be patented must be taken as in compliance with the enabling
requirement of the first paragraph of Section  112 unless there is
reason to doubt the objective truth of the statements contained therein
which must be relied on for enabling support. (emphasis added).

Thus, Langer and subsequent cases direct the Office to presume that a
statement of utility made by an applicant is true. See In re Langer, 503
F.2d at 1391, 183 USPQ at 297; In re Malachowski, 530 F.2d 1402, 1404,
189 USPQ 432, 435 (CCPA 1976); In re Brana, 51 F.3d 1560, 34 USPQ2d 1436
(Fed. Cir. 1995). For obvious reasons of efficiency and in deference to
an applicant's understanding of his or her invention, when a statement
of utility is evaluated, Office personnel should not begin by
questioning the truth of the statement of utility. Instead, any inquiry
must start by asking if there is any reason to question the truth of the
statement of utility. This can be done by simply evaluating the logic of
the statements made, taking into consideration any evidence cited by the
applicant. If the asserted utility is credible (i.e., believable based
on the record or the nature of the invention), a rejection based on
"lack of utility" is not appropriate. Clearly, Office personnel should
not begin an evaluation of utility by assuming that an asserted utility
is likely to be false, based on the technical field of the invention or
for other general reasons.

Compliance with  35 U.S.C. 101 is a question of fact. Raytheon v. Roper,
724 F.2d 951, 956, 220 USPQ 592, 596 (Fed. Cir. 1983) cert. denied, 469
U.S. 835 (1984). Thus, to overcome the presumption of truth that an
assertion of utility by the applicant enjoys, Office personnel must
establish that it is more likely than not that one of ordinary skill in
the art would doubt (i.e., "question") the truth of the statement of
utility. The evidentiary standard to be used throughout ex parte
examination in setting forth a rejection is a preponderance of the
totality of the evidence under consideration.   In re Oetiker, 977 F.2d
1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992) ("After evidence or
argument is submitted by the applicant in response, patentability is
determined on the totality of the record, by a preponderance of evidence
with due consideration to persuasiveness of argument."); In re Corkill,
771 F.2d 1496, 1500, 226 USPQ 1005, 1008 (Fed. Cir. 1985). A
preponderance of the evidence exists when it suggests that it is more
likely than not that the assertion in question is true.   Herman v.
Huddleston, 459 U.S. 375, 390 (1983). To do this, Office personnel must
provide evidence sufficient to show that the statement of asserted
utility would be considered "false" by a person of ordinary skill in the
art. Of course, a person of ordinary skill must have the benefit of both
facts and reasoning in order to assess the truth of a statement. This
means that if the applicant has presented facts that support the
reasoning used in asserting a utility, Office personnel must present
countervailing facts and reasoning sufficient to establish that a person
of ordinary skill would not believe the applicant's assertion of
utility. In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. 1995). The
initial evidentiary standard used during evaluation of this question is
a preponderance of the evidence (i.e., the totality of facts and
reasoning suggest that it is more likely than not that the statement of
the applicant is false).

B. When Is an Asserted Utility Not Credible?

Where an applicant has specifically asserted that an invention has a
particular utility, that assertion cannot simply be dismissed by Office
personnel as being "wrong," even when there may be reason to believe
that the assertion is not entirely accurate. Rather, Office personnel
must determine if the assertion of utility is credible (i.e., whether
the assertion of utility is believable to a person of ordinary skill in
the art based on the totality of evidence and reasoning provided). An
assertion is credible unless (A) the logic underlying the assertion is
seriously flawed, or (B) the facts upon which the assertion is based are
inconsistent with the logic underlying the assertion. Credibility as
used in this context refers to the reliability of the statement based on
the logic and facts that are offered by the applicant to support the
assertion of utility.

One situation where an assertion of utility would not be considered
credible is where a person of ordinary skill would consider the
assertion to be "incredible in view of contemporary knowledge" and where
nothing offered by the applicant would counter what contemporary
knowledge might otherwise suggest. Office personnel should be careful,
however, not to label certain types of inventions as "incredible" or
"speculative" as such labels do not provide the correct focus for the
evaluation of an assertion of utility. "  Incredible utility" is a
conclusion, not a starting point for analysis under  35 U.S.C. 101. A
conclusion that an asserted utility is incredible can be reached only
after the Office has evaluated both the assertion of the applicant
regarding utility and any evidentiary basis of that assertion. The
Office should be particularly careful not to start with a presumption
that an asserted utility is, per se, "incredible" and the proceed to
base a rejection under  35 U.S.C. 101 on that presumption.

Rejections under  35 U.S.C. 101 have been rarely sustained by Federal
courts. Generally speaking, in these rare cases, the  35 U.S.C. 101
rejection was sustained either because the applicant failed to disclose
any utility for the invention or asserted a utility that could only be
true if it violated a scientific principle, such as the second law of
thermodynamics, or a law of nature, or was wholly inconsistent with
contemporary knowledge in the art. In re Gazave, 379 F.2d 973, 978, 154
USPQ 92, 96 (CCPA 1967). Special care therefore should be taken when
assessing the credibility of an asserted therapeutic utility for a
claimed invention. In such cases, a previous lack of success in treating
a disease or condition, or the absence of a proven animal model for
testing the effectiveness of drugs for treating a disorder in humans,
should not, standing alone, serve as a basis for challenging the
asserted utility under  35 U.S.C. 101.

IV. INITIAL BURDEN IS ON THE OFFICE TO ESTABLISH A PRIMA FACIE CASE AND
PROVIDE EVIDENTIARY SUPPORT THEREOF

To properly reject a claimed invention under  35 U.S.C. 101, the Office
must (A) make a prima facie showing that the claimed invention lacks
utility, and (B) provide a sufficient evidentiary basis for factual
assumptions relied upon in establishing the prima facie showing. In re
Gaubert, 524 F.2d 1222, 1224, 187 USPQ 664, 666 (CCPA 1975)
("Accordingly, the PTO must do more than merely question operability -
it must set forth factual reasons which would lead one skilled in the
art to question the objective truth of the statement of operability.").
If the Office cannot develop a proper prima facie case and provide
evidentiary support for a rejection under  35 U.S.C. 101, a rejection on
this ground should not be imposed. See, e.g.,   In re Oetiker, 977 F.2d
1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992) ("[T]he examiner bears
the initial burden, on review of the prior art or on any other ground,
of presenting a prima facie case of unpatentability. If that burden is
met, the burden of coming forward with evidence or argument shifts to
the applicant.... If examination at the initial stage does not produce a
prima facie case of unpatentability, then without more the applicant is
entitled to grant of the patent."). See also Fregeau v. Mossinghoff, 776
F.2d 1034, 227 USPQ 848 (Fed. Cir. 1985) (applying prima facie case law
to  35 U.S.C. 101); In re Piasecki, 745 F.2d 1468, 223 USPQ 785 (Fed.
Cir. 1984).

The prima facie showing must be set forth in a well-reasoned statement.
The statement must articulate sound reasons why a person of ordinary
skill in the art would conclude that it is more likely than not that an
asserted utility is not credible. The statement should specifically
identify the scientific basis of any factual conclusions made in the  
prima facie showing. The statement must also explain why any evidence of
record that supports the asserted utility would not be persuasive to one
of ordinary skill.

In addition to the statement setting forth the   prima facie showing,
Office personnel must provide evidentiary support for the prima facie
case. In most cases, documentary evidence (e.g., articles in scientific
journals, or excerpts from patents or scientific treatises) can and
should be cited to support any factual conclusions made in the   prima
facie showing. Only when documentary evidence is not readily available
should the examiner attempt to satisfy the Office's requirement for
evidentiary support for the factual basis of the prima facie showing
solely through an explanation of relevant scientific principles. It is
imperative that Office personnel use specificity in setting forth an
initial rejection under  35 U.S.C. 101 and support any factual
conclusions made in the   prima facie   showing. For example, Office
personnel should explain why any   in vitro or   in vivo data supplied
by the applicant would not be reasonably predictive of an asserted
therapeutic utility from the perspective of a person of ordinary skill
in the art. By using specificity, the applicant will be able to identify
the assumptions made by the Office in setting forth the rejection and
will be able to address those assumptions properly.

V. EVIDENTIARY REQUESTS BY AN EXAMINER TO SUPPORT AN ASSERTED UTILITY

In appropriate situations the Office may require an applicant to
substantiate an asserted utility for a claimed invention. See In re
Pottier, 376 F.2d 328, 330, 153 USPQ 407, 408 (CCPA 1967) ("When the
operativeness of any process would be deemed unlikely by one of ordinary
skill in the art, it is not improper for the examiner to call for
evidence of operativeness."). See also In re Jolles, 628 F.2d 1322,
1327, 206 USPQ 885, 890 (CCPA 1980); In re Citron, 325 F.2d 248, 139
USPQ 516 (CCPA 1963);   In re Novak, 306 F.2d 924, 928, 134 USPQ 335,
337 (CCPA1962). In In re Citron, the court held that when an "alleged
utility appears to be incredible in the light of the knowledge of the
art, or factually misleading, applicant must establish the asserted
utility by acceptable proof."  325 F.2d at 253, 139 USPQ at 520.  The
court approved of the board's decision which affirmed the rejection
under  35 U.S.C. 101 "  in view of the art knowledge of the lack of a
cure for cancer and the absence of any clinical data to substantiate the
allegation." 325 F.2d at 252, 139 USPQ at 519 (emphasis in original).
The court thus established a higher burden on the applicant where the
statement of use is incredible or misleading. In such a case, the
examiner should challenge the use and require sufficient evidence of
operativeness. The purpose for this authority is to enable an applicant
to cure an otherwise defective factual basis for the operability of an
invention. Because this is a curative authority (e.g., evidence is
requested to enable an applicant to support an assertion that is
inconsistent with the facts of record in the application), Office
personnel should indicate not only why the factual record is defective
in relation to the assertions of the applicant, but also, where
appropriate, what type of evidentiary showing can be provided by the
applicant to remedy the problem.

Requests for additional evidence should be imposed rarely, and only if
necessary to support the scientific credibility of the asserted utility
(e.g., if the asserted utility is not consistent with the evidence of
record and current scientific knowledge). As the Federal Circuit
recently noted, "[o]nly after the PTO provides evidence showing that one
of ordinary skill in the art would reasonably doubt the asserted utility
does the burden shift to the applicant to provide rebuttal evidence
sufficient to convince such a person of the invention's asserted
utility." In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. 1995)
(citing In re Bundy, 642 F.2d 430, 433, 209 USPQ 48, 51 (CCPA 1981)). In
Brana, the court pointed out that the purpose of treating cancer with
chemical compounds does not suggest,   per se, an incredible utility.
Where the prior art disclosed "structurally similar compounds to those
claimed by applicants which have been proven in vivo to be effective as
chemotherapeutic agents against various tumor models . . ., one skilled
in the art would be without basis to reasonably doubt applicants'
asserted utility on its face."  51 F.3d at 1566, 34 USPQ2d at 1441. As
courts have stated, "it is clearly improper for the examiner to make a
demand for further test data, which as evidence would be essentially
redundant and would seem to serve for nothing except perhaps to unduly
burden the applicant." In re Isaacs, 347 F.2d 887, 890, 146 USPQ 193,
196 (CCPA 1965).

VI. CONSIDERATION OF A REPLY TO A   PRIMA FACIE REJECTION FOR LACK OF
UTILITY

If a rejection under  35 U.S.C. 101 has been properly imposed, along
with a corresponding rejection under  35 U.S.C. 112, first paragraph,
the burden shifts to the applicant to rebut the prima facie showing. In
re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992)
("The examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting a prima facie case of
unpatentability. If that burden is met, the burden of coming forward
with evidence or argument shifts to the applicant. . . After evidence or
argument is submitted by the applicant in response, patentability is
determined on the totality of the record, by a preponderance of evidence
with due consideration to persuasiveness of argument."). An applicant
can do this using any combination of the following: amendments to the
claims, arguments or reasoning, or new evidence submitted in an
affidavit or declaration under  37 CFR 1.132, or in a printed
publication. New evidence provided by an applicant must be relevant to
the issues raised in the rejection. For example, declarations in which
conclusions are set forth without establishing a nexus between those
conclusions and the supporting evidence, or which merely express
opinions, may be of limited probative value with regard to rebutting a
prima facie case. In re Grunwell, 609 F.2d 486, 203 USPQ 1055 (CCPA
1979); In re Buchner, 929 F.2d 660, 18 USPQ2d 1331 (Fed. Cir. 1991). See
MPEP Section  716.01(a) through Section  716.01(c).

Once a reply has been provided, Office personnel must review the
complete record, including the claims, to determine if it is appropriate
to maintain the rejections under  35 U.S.C. 101 and  35 U.S.C. 112. If
the record as a whole would make it more likely than not that the
asserted utility for the claimed invention would be considered credible
by a person of ordinary skill in the art, the Office cannot maintain the
rejection. In re Rinehart, 531 F.2d 1048, 1052, 189 USPQ 143, 147 (CCPA
1976).

VII. EVALUATION OF EVIDENCE RELATED TO UTILITY

There is no predetermined amount or character of evidence that must be
provided by an applicant to support an asserted utility, therapeutic or
otherwise. Rather, the character and amount of evidence needed to
support an asserted utility will vary depending on what is claimed (Ex
parte Ferguson, 117 USPQ 229 (Bd. App. 1957)), and whether the asserted
utility appears to contravene established scientific principles and
beliefs. In re Gazave, 379 F.2d 973, 978, 154 USPQ 92, 96 (CCPA 1967);
In re Chilowsky, 229 F.2d 457, 462, 108 USPQ 321, 325 (CCPA 1956).
Furthermore, the applicant does not have to provide evidence sufficient
to establish that an asserted utility is true "beyond a reasonable
doubt." In re Irons, 340 F.2d 974, 978, 144 USPQ 351, 354 (CCPA 1965).
Nor must an applicant provide evidence such that it establishes an
asserted utility as a matter of statistical certainty. Nelson v. Bowler,
626 F.2d 853, 856-57, 206 USPQ 881, 883-84 (CCPA 1980) (reversing the
Board and rejecting Bowler's arguments that the evidence of utility was
statistically insignificant. The court pointed out that a rigorous
correlation is not necessary when the test is reasonably predictive of
the response). See also Rey-Bellet v. Englehardt, 493 F.2d 1380, 181
USPQ 453 (CCPA 1974) (data from animal testing is relevant to asserted
human therapeutic utility if there is a "satisfactory correlation
between the effect on the animal and that ultimately observed in human
beings"). Instead, evidence will be sufficient if, considered as a
whole, it leads a person of ordinary skill in the art to conclude that
the asserted utility is more likely than not true.

---SECTION---2107.02 Special Considerations for Asserted Therapeutic or
Pharmacological Utilities

The Federal courts have consistently reversed rejections by the Office
asserting a lack of utility for inventions claiming a pharmacological or
therapeutic utility where an applicant has provided evidence that
reasonably supports such a utility. In view of this, Office personnel
should be particularly careful in their review of evidence provided in
support of an asserted therapeutic or pharmacological utility.

I. A REASONABLE CORRELATION BETWEEN THE EVIDENCE AND THE ASSERTED
UTILITY IS SUFFICIENT

As a general matter, evidence of pharmacological or other biological
activity of a compound will be relevant to an asserted therapeutic use
if there is a reasonable correlation between the activity in question
and the asserted utility. Cross v. Iizuka, 753 F.2d 1040, 224 USPQ 739
(Fed. Cir. 1985); In re Jolles, 628 F.2d 1322, 206 USPQ 885 (CCPA 1980);
Nelson v. Bowler, 626 F.2d 853, 206 USPQ 881 (CCPA 1980). An applicant
can establish this reasonable correlation by relying on statistically
relevant data documenting the activity of a compound or composition,
arguments or reasoning, documentary evidence (e.g., articles in
scientific journals), or any combination thereof. The applicant does not
have to prove that a correlation exists between a particular activity
and an asserted therapeutic use of a compound as a matter of statistical
certainty, nor does he or she have to provide actual evidence of success
in treating humans where such a utility is asserted. Instead, as the
courts have repeatedly held, all that is required is a reasonable
correlation between the activity and the asserted use Nelson v. Bowler,
626 F.2d 853, 857, 206 USPQ 881, 884 (CCPA 1980).

II. STRUCTURAL SIMILARITY TO COMPOUNDS WITH ESTABLISHED UTILITY

Courts have routinely found evidence of structural similarity to a
compound known to have a particular therapeutic or pharmacological
utility as being supportive of an assertion of therapeutic utility for a
new compound. In In re Jolles, 628 F.2d 1322, 206 USPQ 885 (CCPA 1980),
the claimed compounds were found to have utility based on a finding of a
close structural relationship to daunorubicin and doxorubicin and shared
pharmacological activity with those compounds, both of which were known
to be useful in cancer chemotherapy.  The evidence of close structural
similarity with the known compounds was presented in conjunction with
evidence demonstrating substantial activity of the claimed compounds in
animals customarily employed for screening anticancer agents. Such
evidence should be given appropriate weight in determining whether one
skilled in the art would find the asserted utility credible. Office
personnel should evaluate not only the existence of the structural
relationship, but also the reasoning used by the applicant or a
declarant to explain why that structural similarity is believed to be
relevant to the applicant's assertion of utility.

III. DATA FROM IN VITRO OR ANIMAL TESTING IS GENERALLY SUFFICIENT TO
SUPPORT THERAPEUTIC UTILITY

If reasonably correlated to the particular therapeutic or
pharmacological utility, data generated using in vitro assays, or from
testing in an animal model or a combination thereof almost invariably
will be sufficient to establish therapeutic or pharmacological utility
for a compound, composition or process. A cursory review of cases
involving therapeutic inventions where  35 U.S.C. 101 was the
dispositive issue illustrates the fact that the Federal courts are not
particularly receptive to rejections under  35 U.S.C. 101 based on
inoperability. Most striking is the fact that in those cases where an
applicant supplied a reasonable evidentiary showing supporting an
asserted therapeutic utility, almost uniformly the  35 U.S.C. 101-based
rejection was reversed. See, e.g.,   In re Brana, 51 F.3d 1560, 34 USPQ
1436 (Fed. Cir. 1995); Cross v. Iizuka, 753 F.2d 1040, 224 USPQ 739
(Fed. Cir. 1985);   In re Jolles, 628 F.2d 1322, 206 USPQ 885 (CCPA
1980); Nelson v. Bowler, 626 F.2d 853, 856, 206 USPQ 881, 883 (CCPA
1980); In re Malachowski, 530 F.2d 1402, 189 USPQ 432 (CCPA 1976); In re
Gaubert, 530 F.2d 1402, 189 USPQ 432 (CCPA 1975); In re Gazave, 379 F.2d
973, 154 USPQ 92 (CCPA 1967); In re Hartop, 311 F.2d 249, 135 USPQ 419
(CCPA 1962); In re Krimmel, 292 F.2d 948, 130 USPQ 215 (CCPA 1961). Only
in those cases where the applicant was unable to come forward with any
relevant evidence to rebut a finding by the Office that the claimed
invention was inoperative was a  35 U.S.C. 101 rejection affirmed by the
court. In re Citron, 325 F.2d 248, 253, 139 USPQ 516, 520 (CCPA 1963)
(therapeutic utility for an uncharacterized biological extract not
supported or scientifically credible); In re Buting, 418 F.2d 540, 543,
163 USPQ 689, 690 (CCPA 1969) (record did not establish a credible basis
for the assertion that the single class of compounds in question would
be useful in treating disparate types of cancers); In re Novak, 306 F.2d
924, 134 USPQ 335 (CCPA 1962) (claimed compounds did not have capacity
to effect physiological activity upon which utility claim based).
Contrast, however, In re Buting to In re Gardner, 475 F.2d 1389, 177
USPQ 396 (CCPA 1973), reh'g denied, 480 F.2d 879 (CCPA 1973), in which
the court held that utility for a genus was found to be supported
through a showing of utility for one species. In no case has a Federal
court required an applicant to support an asserted utility with data
from human clinical trials.

If an applicant provides data, whether from in vitro assays or animal
tests or both, to support an asserted utility, and an explanation of why
that data supports the asserted utility, the Office will determine if
the data and the explanation would be viewed by one skilled in the art
as being reasonably predictive of the asserted utility. See, e.g., Ex
parte Maas, 9 USPQ2d 1746 (Bd. Pat. App. & Inter. 1987); Ex parte
Balzarini, 21 USPQ2d 1892 (Bd. Pat. App. & Inter. 1991). Office
personnel must be careful to evaluate all factors that might influence
the conclusions of a person of ordinary skill in the art as to this
question, including the test parameters, choice of animal, relationship
of the activity to the particular disorder to be treated,
characteristics of the compound or composition, relative significance of
the data provided and, most importantly, the explanation offered by the
applicant as to why the information provided is believed to support the
asserted utility. If the data supplied is consistent with the asserted
utility, the Office cannot maintain a rejection under  35 U.S.C. 101.

Evidence does not have to be in the form of data from an art-recognized
animal model for the particular disease or disease condition to which
the asserted utility relates. Data from any test that the applicant
reasonably correlates to the asserted utility should be evaluated
substantively. Thus, an applicant may provide data generated using a
particular animal model with an appropriate explanation as to why that
data supports the asserted utility. The absence of a certification that
the test in question is an industry-accepted model is not dispositive of
whether data from an animal model is in fact relevant to the asserted
utility. Thus, if one skilled in the art would accept the animal tests
as being reasonably predictive of utility in humans, evidence from those
tests should be considered sufficient to support the credibility of the
asserted utility. In re Hartop, 311 F.2d 249, 135 USPQ 419 (CCPA 1962);
In re Krimmel, 292 F.2d 948, 953, 130 USPQ 215, 219 (CCPA 1961); Ex
parte Krepelka, 231 USPQ 746 (Bd. Pat. App. & Inter. 1986). Office
personnel should be careful not to find evidence unpersuasive simply
because no animal model for the human disease condition had been
established prior to the filing of the application. See In re Chilowsky,
229 F.2d 457, 461, 108 USPQ 321, 325 (CCPA 1956) ("The mere fact that
something has not previously been done clearly is not, in itself, a
sufficient basis for rejecting all applications purporting to disclose
how to do it."); In re Wooddy, 331 F.2d 636, 639, 141 USPQ 518, 520
(CCPA 1964) ("It appears that no one on earth is certain as of the
present whether the process claimed will operate in the manner claimed.
Yet absolute certainty is not required by the law. The mere fact that
something has not previously been done clearly is not, in itself, a
sufficient basis for rejecting all applications purporting to disclose
how to do it.").

IV. HUMAN CLINICAL DATA

Office personnel should not impose on applicants the unnecessary burden
of providing evidence from human clinical trials. There is no decisional
law that requires an applicant to provide data from human clinical
trials to establish utility for an invention related to treatment of
human disorders (see In re Isaacs, 347 F.2d 889, 146 USPQ 193 (CCPA
1963); In re Langer, 503 F.2d 1380, 183 USPQ 288 (CCPA 1974)), even with
respect to situations where no art-recognized animal models existed for
the human disease encompassed by the claims. Ex parte Balzarini, 21
USPQ2d 1892 (Bd. Pat. App. & Inter. 1991) (human clinical data is not
required to demonstrate the utility of the claimed invention, even
though those skilled in the art might not accept other evidence to
establish the efficacy of the claimed therapeutic compositions and the
operativeness of the claimed methods of treating humans). Before a drug
can enter human clinical trials, the sponsor, often the applicant, must
provide a convincing rationale to those especially skilled in the art
(e.g., the Food and Drug Administration) that the investigation may be
successful. Such a rationale would provide a basis for the sponsor's
expectation that the investigation may be successful. In order to
determine a protocol for phase I testing, the first phase of clinical
investigation, some credible rationale of how the drug might be
effective or could be effective would be necessary. Thus, as a general
rule, if an applicant has initiated human clinical trials for a
therapeutic product or process, Office personnel should presume that the
applicant has established that the subject matter of that trial is
reasonably predictive of having the asserted therapeutic utility.

V. SAFETY AND EFFICACY CONSIDERATIONS

The Office must confine its review of patent applications to the
statutory requirements of the patent law. Other agencies of the
government have been assigned the responsibility of ensuring conformance
to standards established by statute for the advertisement, use, sale or
distribution of drugs. The FDA pursues a two-prong test to provide
approval for testing. Under that test, a sponsor must show that the
investigation does not pose an unreasonable and significant risk of
illness or injury and that there is an acceptable rationale for the
study. As a review matter, there must be a rationale for believing that
the compound could be effective. If the use reviewed by the FDA is not
set forth in the specification, FDA review may not satisfy  35 U.S.C.
101. However, if the reviewed use is one set forth in the specification,
Office personnel must be extremely hesitant to challenge utility. In
such a situation, experts at the FDA have assessed the rationale for the
drug or research study upon which an asserted utility is based and found
it satisfactory. Thus, in challenging utility, Office personnel must be
able to carry their burden that there is no sound rationale for the
asserted utility even though experts designated by Congress to decide
the issue have come to an opposite conclusion. "FDA approval, however,
is not a prerequisite for finding a compound useful within the meaning
of the patent laws." In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed.
Cir. 1995) (citing Scott v. Finney, 34 F.3d 1058, 1063, 32 USPQ2d 1115,
1120 (Fed. Cir. 1994)).

Thus, while an applicant may on occasion need to provide evidence to
show that an invention will work as claimed, it is improper for Office
personnel to request evidence of safety in the treatment of humans, or
regarding the degree of effectiveness. See In re Sichert, 566 F.2d 1154,
196 USPQ 209 (CCPA 1977); In re Hartop, 311 F.2d 249, 135 USPQ 419 (CCPA
1962); In re Anthony, 414 F.2d 1383, 162 USPQ 594 (CCPA 1969); In re
Watson, 517 F.2d 465, 186 USPQ 11 (CCPA 1975); In re Krimmel, 292 F.2d
948, 130 USPQ 215 (CCPA 1961);   Ex parte Jovanovics, 211 USPQ 907 (Bd.
Pat. App. & Inter. 1981).

VI. TREATMENT OF SPECIFIC DISEASE CONDITIONS

Claims directed to a method of treating or curing a disease for which
there have been no previously successful treatments or cures warrant
careful review for compliance with  35 U.S.C. 101. The credibility of an
asserted utility for treating a human disorder may be more difficult to
establish where current scientific understanding suggests that such a
task would be impossible. Such a determination has always required a
good understanding of the state of the art as of the time that the
invention was made. For example, prior to the 1980's, there were a
number of cases where an asserted use in treating cancer in humans was
viewed as "incredible." In re Jolles, 628 F.2d 1322, 206 USPQ 885 (CCPA
1980); In re Buting, 418 F.2d 540, 163 USPQ 689 (CCPA 1969); Ex parte
Stevens, 16 USPQ2d 1379 (Bd. Pat. App. & Inter. 1990); Ex parte Busse, 1
USPQ2d 1908 (Bd. Pat. App. & Inter. 1986); Ex parte Krepelka, 231 USPQ
746 (Bd. Pat. App. & Inter. 1986); Ex parte Jovanovics, 211 USPQ 907
(Bd. Pat. App. & Inter. 1981). The fact that there is no known cure for
a disease, however, cannot serve as the basis for a conclusion that such
an invention lacks utility. Rather, Office personnel must determine if
the asserted utility for the invention is credible based on the
information disclosed in the application. Only those claims for which an
asserted utility is not credible should be rejected. In such cases, the
Office should carefully review what is being claimed by the applicant.
An assertion that the claimed invention is useful in treating a symptom
of an incurable disease may be considered credible by a person of
ordinary skill in the art on the basis of a fairly modest amount of
evidence or support. In contrast, an assertion that the claimed
invention will be useful in "curing" the disease may require a
significantly greater amount of evidentiary support to be considered
credible by a person of ordinary skill in the art. In re Sichert, 566
F.2d 1154, 196 USPQ 209 (CCPA 1977); In re Jolles, 628 F.2d 1322, 206
USPQ 885 (CCPA 1980). See also Ex parte Ferguson, 117 USPQ 229 (Bd. Pat.
App. & Inter. 1957).

In these cases, it is important to note that the Food and Drug
Administration has promulgated regulations that enable a party to
conduct clinical trials for drugs used to treat life threatening and
severely-debilitating illnesses, even where no alternative therapy
exists. See  21 CFR 312.80-88 (1994). Implicit in these regulations is
the recognition that experts qualified to evaluate the effectiveness of
therapeutics can and often do find a sufficient basis to conduct
clinical trials of drugs for incurable or previously untreatable
illnesses. Thus, affidavit evidence from experts in the art indicating
that there is a reasonable expectation of success, supported by sound
reasoning, usually should be sufficient to establish that such a utility
is credible.

---SECTION---2111 Claim Interpretation; Broadest Reasonable
Interpretation

CLAIMS MUST BE GIVEN THEIR BROADEST REASONABLE INTERPRETATION

During patent examination, the pending claims must be "given the
broadest reasonable interpretation consistent with the specification."
Applicant always has the opportunity to amend the claims during
prosecution and broad interpretation by the examiner reduces the
possibility that the claim, once issued, will be interpreted more
broadly than is justified. In re Prater, 415 F.2d 1393, 1404-05, 162
USPQ 541, 550-51 (CCPA 1969) (Claim 9 was directed to a process of
analyzing data generated by mass spectrographic analysis of a gas. The
process comprised selecting the data to be analyzed by subjecting the
data to a mathematical manipulation. The examiner made rejections under 
35 U.S.C. 101 and 102. In the section 102 rejection, the examiner
explained that the claim was anticipated by a mental process augmented
by pencil and paper markings. The court agreed that the claim was not
limited to using a machine to carry out the process since the claim did
not explicitly set forth the machine. The court explained that "reading
a claim in light of the specification, to thereby interpret limitations
explicitly recited in the claim, is a quite different thing from
"reading limitations of the specification into a claim," to thereby
narrow the scope of the claim by implicitly adding disclosed limitations
which have no express basis in the claim." The court found that
applicant was advocating the latter, e.g., the impermissible importation
of subject matter from the specification into the claim.).  See also In
re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir.
1997) (The court held that the PTO is not required, in the course of
prosecution, to interpret claims in applications in the same manner as a
court would in interpreting claims in an infringement suit.  Rather, the
"PTO applies to verbiage of the proposed claims the broadest reasonable
meaning of the words in their ordinary usage as they would be understood
by one of ordinary skill in the art, taking into account whatever
enlightenment by way of definitions or otherwise that may be afforded by
the written description contained in applicant's specification.").

---SECTION---2111.01 Plain Meaning

THE WORDS OF A CLAIM MUST BE GIVEN THEIR "PLAIN MEANING" UNLESS THEY ARE
DEFINED IN THE SPECIFICATION

While the meaning of claims of issued patents are interpreted in light
of the specification, prosecution history, prior art and other claims,
this is not the mode of claim interpretation to be applied during
examination. During examination, the claims must be interpreted as
broadly as their terms reasonably allow. This means that the words of
the claim must be given their plain meaning unless applicant has
provided a clear definition in the specification. In re Zletz, 893 F.2d
319, 321, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989)(discussed below). One
must bear in mind that, especially in nonchemical cases, the words in a
claim are generally not limited in their meaning by what is shown or
disclosed in the specification. It is only when the specification
provides definitions for terms appearing in the claims that the
specification can be used in interpreting claim language. In re Vogel,
422 F.2d 438, 441, 164 USPQ 619, 622 (CCPA 1970). There is one exception
and that is when an element is claimed using language falling under the
scope of  35 U.S.C. 112, 6th paragraph (often broadly referred to as
means or step plus function language). In that case, the specification
must be consulted to determine the structure, material, or acts
corresponding to the function recited in the claim. In re Donaldson, 16
F.3d 1189, 29 USPQ2d 1845 (Fed. Cir. 1994)(see MPEP Section  2181- 
Section  2186).

In In re Zletz,   supra, the examiner and the Board had interpreted
claims reading "normally solid polypropylene" and "normally solid
polypropylene having a crystalline polypropylene content" as being
limited to "normally solid linear high homopolymers of propylene which
have a crystalline polypropylene content." The court ruled that
limitations, not present in the claims, were improperly imported from
the specification. See also   In re Marosi, 710 F.2d 799,218 USPQ 289
(Fed. Cir. 1983) ("Claims are not to be read in a vacuum, and
limitations therein are to be interpreted in light of the specification
in giving them their "broadest reasonable interpretation." 710 F.2d at
802, 218 USPQ at 292 (quoting In re Okuzawa, 537 F.2d 545, 548, 190 USPQ
464, 466 (CCPA 1976))(emphasis in original). The court looked to the
specification to construe "essentially free of alkali metal" as
including unavoidable levels of impurities but no more.). Compare In re
Weiss, 989 F.2d 1202, 26 USPQ2d 1885 (Fed. Cir. 1993) (unpublished
decision - cannot be cited as precedent) (The claim related to an
athletic shoe with cleats that "break away at a preselected level of
force" and thus prevent injury to the wearer. The examiner rejected the
claims over prior art teaching athletic shoes with cleats not intended
to break off and rationalized that the cleats would break away given a
high enough force. The court reversed the rejection stating that when
interpreting a claim term which is ambiguous, such as `a preselected
level of force,' we must look to the specification for the meaning
ascribed to that term by the inventor." The specification had defined
"preselected level of force..." as that level of force at which the
breaking away will prevent injury to the wearer during athletic
exertion. It should be noted that the limitation was part of a means
plus function element.)

 "PLAIN MEANING" REFERS TO THE MEANING GIVEN TO THE TERM BY THOSE OF
ORDINARY SKILL IN THE ART

When not defined by applicant in the specification, the words of a claim
must be given their plain meaning. In other words, they must be read as
they would be interpreted by those of ordinary skill in the art. In re
Sneed, 710 F.2d 1544, 218 USPQ 385 (Fed. Cir. 1983) (The applicants had
argued in an amendment after final rejection that the term "flexible
plastic pipe," as used in the claims, pertained only to pipes of 2-inch
diameter and 3-inch diameter and not to a pipe of 1.5 inch diameter.
This definition of "flexible" was also advanced in an affidavit. The
prior art, however, described 1.5 inch pipe as flexible. The court held
that the specification and the evidence (the prior art) failed to
support the gloss appellants sought to put on the term "flexible." Note
that applicant had not defined "flexible plastic pipe" in the
specification.); In re Barr, 444 F.2d 588, 597, 170 USPQ 330, 339 (CCPA
1971) ("The specification in this case attempts no definition of the
claim language `a phenyl radical.' Accordingly we must presume that the
phrase was used in its commonly accepted technical sense.... Applicants]
have not referred us to any standard work on chemistry which indicates
that the commonly accepted technical meaning of the words `a phenyl
radical', without more, would encompass the hydroxyphenyl radical. On
the contrary, Hackh's [Chemical Dictionary] quite plainly defines
`phenyl' as `the monovalent radical... derived from benzene... or
phenol.' ").

APPLICANT MAY BE OWN LEXICOGRAPHER

Applicant may be his or her own lexicographer as long as the meaning
assigned to the term is not repugnant to the term's well known usage. In
re Hill, 161 F.2d 367, 73 USPQ 482 (CCPA 1947).

---SECTION---2111.02 Weight of Preamble

PREAMBLE IS NONLIMITING UNLESS IT BREATHES LIFE AND MEANING INTO THE
CLAIM

The preamble is not given the effect of a limitation unless it breathes
life and meaning into the claim. In order to limit the claim, the
preamble must be "essential to point out the invention defined by the
claim." Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951)
(discussed below). In claims directed to articles and apparatus, any
phraseology in the preamble that limits the structure of that article or
apparatus must be given weight. In re Stencel, 828 F.2d 751, 4 USPQ2d
1071 (Fed. Cir. 1987) (discussed below). On the other hand, a preamble
is generally not accorded any patentable weight where it merely recites
the purpose of a process or the intended use of a structure, and where
the body of the claim does not depend on the preamble for completeness
but, instead, the process steps or structural limitations are able to
stand alone.   In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976)
(process claims, discussed below); Kropa v. Robie, 187 F.2d at 152, 88
USPQ at 481 (claims directed to apparatus, products, chemical structure,
etc., as discussed below).

In   In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976), the claim
preamble set forth "A process for preparing foods and drinks sweetened
mildly, and protected against discoloration, Streckler's reaction, and
moisture absorption." The body of the claim recited two steps directed
to the formation of high purity maltose and a third step of adding the
maltose to foods and drinks as a sweetener. The court held that the
preamble was only directed to the purpose of the process, the steps
could stand alone and did not depend on the preamble for completeness.

In   Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951), a
preamble reciting "An abrasive article" was deemed essential to point
out the invention defined by claims to an article comprising abrasive
grains and a hardened binder and the process of making it. The court
said that "it is only by that phrase that it can be known that the
subject matter defined by the claims is comprised as an abrasive
article. Every union of substances capable inter alia of use as abrasive
grains and a binder is not an `abrasive article.' " Id. at 481, 187 F.2d
at 152. Therefore, the preamble served to further define the structure
of the article produced.

In In re Stencel, 828 F.2d 751, 4 USPQ2d 1071 (Fed. Cir. 1987), the
claim was directed to a driver for setting a joint of a threaded collar.
The claim did not directly include the structure of the collar as part
of the claimed article. The preamble did set forth the structure of the
collar but the examiner had not given this recitation any weight. The
court found that the collar structure could not be ignored. While the
claim was not directly limited to the collar, the collar structure
recited in the preamble did limit the structure of the driver. The court
stated that "the framework - the teachings of the prior art - against
which patentability is measured is not all drivers broadly, but drivers
suitable for use in combination with this collar, for the claims are so
limited." Id. at 1073, 828 F.2d at 754.

COMPOSITION CLAIMS - THE PREAMBLE IS GENERALLY NONLIMITING IF THE
PREAMBLE MERELY RECITES AN INHERENT PROPERTY

When the claim is directed to a product, the preamble is generally
nonlimiting if the body of the claim is directed to an old composition
and the preamble merely recites a property inherent in the old
composition. Kropa v. Robie, 187 F.2d at 152, 88 USPQ at 480-81.

THE INTENDED USE MAY FURTHER LIMIT THE CLAIM IF IT DOES MORE THAN MERELY
STATE PURPOSE OR INTENDED USE

Intended use recitations and other types of functional language cannot
be entirely disregarded. However, in apparatus, article, and composition
claims, intended use must result in a structural difference between the
claimed invention and the prior art in order to patentably distinguish
the claimed invention from the prior art. If the prior art structure is
capable of performing the intended use, then it meets the claim. In a
claim drawn to a process of making, the intended use must result in a
manipulative difference as compared to the prior art. In re Casey, 370
F.2d 576, 152 USPQ 235 (CCPA 1967);   In re Otto, 312 F.2d 937, 938, 136
USPQ 458, 459 (CCPA 1963) (The claims were directed to a core member for
hair curlers and a process of making a core member for hair curlers.
Court held that the intended use of hair curling was of no significance
to the structure and process of making.)

---SECTION---2111.03 Transitional Phrases

The transitional phrases "comprising", "consisting essentially of" and
"consisting of" define the scope of a claim with respect to what
unrecited additional components or steps, if any, are excluded from the
scope of the claim.

The transitional term "comprising", which is synonymous with
"including," "containing," or "characterized by," is inclusive or
open-ended and does not exclude additional, unrecited elements or method
steps. Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 229 USPQ
805 (Fed. Cir. 1986); In re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803
(CCPA 1981); Ex parte Davis, 80 USPQ 448, 450 (Bd. App.
1948)("comprising" leaves "the claim open for the inclusion of
unspecified ingredients even in major amounts").

The transitional phrase "consisting of" excludes any element, step, or
ingredient not specified in the claim. In re Gray, 53 F.2d 520, 11 USPQ
255 (CCPA 1931); Ex parte Davis, 80 USPQ 448, 450 (Bd. App.
1948)("consisting of" defined as "closing the claim to the inclusion of
materials other than those recited except for impurities ordinarily
associated therewith."). Transitional phrases such as "composed of,"
"having," or "being" must be interpreted in light of the specification
to determine whether open or closed claim language is intended.  A claim
which depends from a claim which "consists of" the recited elements or
steps cannot add an element or step.  When the phrase "consists of"
appears in a clause of the body of a claim, rather than immediately
following the preamble, it limits only the element set forth in that
clause; other elements are not excluded from the claim as a whole.
Mannesmann Demag Corp. v. Engineered Metal Products Co., 793 F.2d 1279,
230 USPQ 45 (Fed. Cir. 1986).

The transitional phrase "consisting essentially of" limits the scope of
a claim to the specified materials or steps "and those that do not
materially affect the basic and novel characteristic(s)" of the claimed
invention. In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463 (CCPA
1976) (emphasis in original)(Prior art hydraulic fluid required a
dispersant which appellants argued was excluded from claims limited to a
functional fluid "consisting essentially of" certain components. In
finding the claims did not exclude the prior art dispersant, the court
noted that appellants' specification indicated the claimed composition
can contain any well-known additive such as a dispersant, and there was
no evidence that the presence of a dispersant would materially affect
the basic and novel characteristic of the claimed invention.  The prior
art composition had the same basic and novel characteristic (increased
oxidation resistance) as well as additional enhanced detergent and
dispersant characteristics.).  See also Atlas Powder Co. v. E.I. duPont
de Nemours & Co., 750 F.2d 1569, 224 USPQ 409 (Fed. Cir. 1984); In re
Janakirama-Rao, 317 F.2d 951, 137 USPQ 893 (CCPA 1963); Water
Technologies Corp. v. Calco, Ltd., 850 F.2d 660, 7 USPQ2d 1097 (Fed.
Cir. 1988).  When an applicant contends that additional steps or
materials in the prior art are excluded by the recitation of "consisting
essentially of," applicant has the burden of showing that the
introduction of additional steps or components would materially change
the characteristics of applicant's invention. In re De Lajarte, 337 F.2d
870, 143 USPQ 256 (CCPA 1964).  See also Ex parte Hoffman, 12 USPQ2d
1061, 1063-64 (Bd. Pat. App. & Inter. 1989)("Although `consisting
essentially of' is typically used and defined in the context of
compositions of matter, we find nothing intrinsically wrong with the use
of such language as a modifier of method steps. . . [rendering] the
claim open only for the inclusion of steps which do not materially
affect the basic and novel characteristics of the claimed method.  To
determine the steps included versus excluded the claim must be read in
light of the specification. . . .  [I]t is an applicant's burden to
establish that a step practiced in a prior art method is excluded from
his claims by `consisting essentially of' language.").

---SECTION---2112 Requirements of Rejection Based on Inherency; Burden
of Proof

The express, implicit, and inherent disclosures of a prior art reference
may be relied upon in the rejection of claims under  35 U.S.C. 102 or
103.  "The inherent teaching of a prior art reference, a question of
fact, arises both in the context of anticipation and obviousness." In re
Napier, 55 F.3d 610, 613, 34 USPQ2d 1782, 1784 (Fed. Cir. 1995)(affirmed
a  35 U.S.C. 103 rejection based in part on inherent disclosure in one
of the references).  See also In re Grasselli, 713 F.2d 731, 739, 218
USPQ 769, 775 (Fed. Cir. 1983).

SOMETHING WHICH IS OLD DOES NOT BECOME PATENTABLE UPON THE DISCOVERY OF
A NEW PROPERTY

The claiming of a new use, new function or unknown property which is
inherently present in the prior art does not necessarily make the claim
patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA
1977).  See also MPEP Section  2112.01 with regard to inherency and
product-by-process claims and MPEP Section  2141.02 with regard to
inherency and rejections under  35 U.S.C. 103.

A REJECTION UNDER 35 U.S.C. 102/103 CAN BE MADE WHEN THE PRIOR ART
PRODUCT SEEMS TO BE IDENTICAL EXCEPT THAT THE PRIOR ART IS SILENT AS TO
AN INHERENT CHARACTERISTIC

Where applicant claims a composition in terms of a function, property or
characteristic and the composition of the prior art is the same as that
of the claim but the function is not explicitly disclosed by the
reference, the examiner may make a rejection under both  35 U.S.C. 102
and 103, expressed as a 102/103 rejection. "There is nothing
inconsistent in concurrent rejections for obviousness under  35 U.S.C.
103 and for anticipation under  35 U.S.C. 102." In re Best, 562 F.2d
1252, 1255 n.4, 195 USPQ 430, 433 n.4 (CCPA 1977). This same rationale
should also apply to product, apparatus, and process claims claimed in
terms of function, property or characteristic. Therefore,  35 U.S.C.
102/103 rejection is appropriate for these types of claims as well as
for composition claims.

EXAMINER MUST PROVIDE RATIONALE OR EVIDENCE TENDING TO SHOW INHERENCY

The fact that a certain result or characteristic may occur or be present
in the prior art is not sufficient to establish the inherency of that
result or characteristic. In re Rijckaert, 9 F.3d 1531, 1534, 28 USPQ2d
1955, 1957 (Fed. Cir. 1993)(reversed rejection because inherency was
based on what would result due to optimization of conditions, not what
was necessarily present in the prior art); In re Oelrich, 666 F.2d 578,
581-82, 212 USPQ 323, 326 (CCPA 1981).

"In relying upon the theory of inherency, the examiner must provide a
basis in fact and/or technical reasoning to reasonably support the
determination that the allegedly inherent characteristic necessarily
flows from the teachings of the applied prior art." Ex parte Levy, 17
USPQ2d 1461, 1464 (Bd. Pat. App. & Inter. 1990) (emphasis in original)
(Applicant's invention was directed to a biaxially oriented, flexible
dilation catheter balloon (a tube which expands upon inflation) used,
for example, in clearing the blood vessels of heart patients). The
examiner applied a U.S. patent to Schjeldahl which disclosed injection
molding a tubular preform and then injecting air into the preform to
expand it against a mold (blow molding). The reference did not directly
state that the end product balloon was biaxially oriented. It did
disclose that the balloon was "formed from a thin flexible inelastic,
high tensile strength, biaxially oriented synthetic plastic material."
Id. at 1462 (emphasis in original). The examiner argued that
Schjeldahl's balloon was inherently biaxially oriented. The Board
reversed on the basis that the examiner did not provide objective
evidence or cogent technical reasoning to support the conclusion of
inherency.).

In In re Schreiber, 128 F.3d 1473, 44 USPQ2d 1429 (Fed. Cir. 1997), the
court affirmed a finding that a prior patent to a conical spout used
primarily to dispense oil from an oil can inherently performed the
functions recited in applicant's claim to a conical container top for
dispensing popped popcorn.  The examiner had asserted inherency based on
the structural similarity between the patented spout and applicant's
disclosed top, i.e., both structures had the same general shape. The
court stated:

[N]othing in Schreiber's [applicant's] claim suggests that Schreiber's
container is of a `different shape' than Harz's [patent].  In fact, [ ]
an embodiment according to Harz (Fig. 5) and the embodiment depicted in
Fig. 1 of Schreiber's application have the same general shape.  For that
reason, the examiner was justified in concluding that the opening of a
conically shaped top as disclosed by Harz is inherently of a size
sufficient to `allow [ ] several kernels of popped popcorn to pass
through at the same time' and that the taper of Harz's conically shaped
top is inherently of such a shape `as to by itself jam up the popped
popcorn before the end of the cone and permit the dispensing of only a
few kernels at a shake of a package when the top is mounted to the
container.' The examiner therefore correctly found that Harz established
a prima facie case of anticipation.

In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432.

ONCE A REFERENCE TEACHING PRODUCT APPEARING TO BE SUBSTANTIALLY
IDENTICAL IS MADE THE BASIS OF A REJECTION AND THE EXAMINER PRESENTS
EVIDENCE OR REASONING TENDING TO SHOW INHERENCY, THE BURDEN SHIFTS TO
THE APPLICANT TO SHOW AN UNOBVIOUS DIFFERENCE

"[T]he PTO can require an applicant to prove that the prior art products
do not necessarily or inherently possess the characteristics of his [or
her] claimed product. Whether the rejection is based on `inherency'
under  35 U.S.C. 102, on `prima facie obviousness' under  35 U.S.C. 103,
jointly or alternatively, the burden of proof is the same...[footnote
omitted]." The burden of proof is similar to that required with respect
to product-by-process claims. In re Fitzgerald, 619 F. 2d 67, 70,   205
USPQ 594, 596 (CCPA 1980) (quoting In re Best, 562 F.2d 1252, 1255, 195
USPQ 430, 433-34 (CCPA 1977)).

In   In re Fitzgerald, the claims were directed to a self-locking
screw-threaded fastener comprising a metallic threaded fastener having
patches of crystallizable thermoplastic bonded thereto. The claim
further specified that the thermoplastic had a reduced degree of
crystallization shrinkage. The specification disclosed that the locking
fastener was made by heating the metal fastener to melt a thermoplastic
blank which is pressed against the metal. After the thermoplastic
adheres to the metal fastener, the end product is cooled by quenching in
water. The examiner made a rejection based on a U.S. patent to Barnes.
Barnes taught a self-locking fastener in which the patch of
thermoplastic was made by depositing thermoplastic powder on a metallic
fastener which was then heated. The end product was cooled in ambient
air, by cooling air or by contacting the fastener with a water trough.
The court first noted that the two fasteners were identical or only
slightly different from each other. "Both fasteners possess the same
utility, employ the same crystallizable polymer (nylon 11), and have an
adherent plastic patch formed by melting and then cooling the polymer."
Id. at 596 n.1, 619 F.2d at 70 n,l. The court then noted that the Board
had found that Barnes' cooling rate could reasonably be expected to
result in a polymer possessing the claimed crystallization shrinkage
rate. Applicant had not rebutted this finding with evidence that the
shrinkage rate was indeed different. They had only argued that the
crystallization shrinkage rate was dependent on the cool down rate and
that the cool down rate of Barnes was much slower than theirs. Because a
difference in the cool down rate does not necessarily result in a
difference in shrinkage, objective evidence was required to rebut the 
35 U.S.C. 102/103 prima facie case.

In In re Schreiber, 128 F.3d 1473, 1478, 44 USPQ2d 1429, 1432
(Fed.Cir.1997), the court held that applicant's declaration failed to
overcome a prima facie case of anticipation because the declaration did
not specify the dimensions of either the dispensing top that was tested
or the popcorn that was used.  Applicant's declaration merely asserted
that a conical dispensing top built according to a figure in the prior
art patent was too small to jam and dispense popcorn and thus could not
inherently perform the functions recited in applicant's claims. The
court pointed out the disclosure of the prior art patent was not limited
to use as an oil can dispenser, but rather was broader than the precise
configuration shown in the patent's figure.  The court also noted that
the Board of Patent Appeals and Interferences found as a factual matter
that a scaled-up version of the top disclosed in the patent would be
capable of performing the functions recited in applicant's claim.

See MPEP Section  2113 for more information on the analogous burden of
proof applied to product-by-process claims.

---SECTION---2112.01 Composition, Product, and Apparatus Claims

PRODUCT AND APPARATUS CLAIMS - WHEN THE STRUCTURE RECITED IN THE
REFERENCE IS SUBSTANTIALLY IDENTICAL TO THAT OF the CLAIMS, CLAIMED
PROPERTIES OR FUNCTIONS ARE PRESUMED TO BE INHERENT

Where the claimed and prior art products are identical or substantially
identical in structure or composition, or are produced by identical or
substantially identical processes, a prima facie case of either
anticipation or obviousness has been established. In re Best, 562 F.2d
1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound
basis for believing that the products of the applicant and the prior art
are the same, the applicant has the burden of showing that they are
not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir.
1990). Therefore, the   prima facie case can be rebutted by evidence
showing that the prior art products do not necessarily possess the
characteristics of the claimed product. In re Best, 562 F.2d at 1255,
195 USPQ at 433.  See also Titanium Metals Corp. v. Banner, 778 F.2d
775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium
alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion
resistance. A Russian article disclosed a titanium alloy containing
0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The
Federal Circuit held that the claim was anticipated because the
percentages of Mo and Ni were squarely within the claimed ranges. The
court went on to say that it was immaterial what properties the alloys
had or who discovered the properties because the composition is the same
and thus must necessarily exhibit the properties.).

See also   In re Ludtke, 441 F.2d 660, 169 USPQ 563 (CCPA 1971) (Claim 1
was directed to a parachute canopy having concentric circumferential
panels radially separated from each other by radially extending tie
lines. The panels were separated "such that the critical velocity of
each successively larger panel will be less than the critical velocity
of the previous panel, whereby said parachute will sequentially open and
thus gradually decelerate." The court found that the claim was
anticipated by Menget. Menget taught a parachute having three
circumferential panels separated by tie lines. The court upheld the
rejection finding that applicant had failed to show that   Menget   did
not possess the functional characteristics of the claims.); Northam
Warren Corp. v. D. F. Newfield Co., 7 F. Supp  . 773, 22 USPQ 313
(E.D.N.Y. 1934) (A patent to a pencil for cleaning fingernails was held
invalid because a pencil of the same structure for writing was found in
the prior art.).

COMPOSITION CLAIMS - IF THE COMPOSITION IS PHYSICALLY THE SAME, IT MUST
HAVE THE SAME PROPERTIES

"Products of identical chemical composition can not have mutually
exclusive properties." A chemical composition and its properties are
inseparable. Therefore, if the prior art teaches the identical chemical
structure, the properties applicant discloses and/or claims are
necessarily present.   In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655,
1658 (Fed. Cir. 1990) (Applicant argued that the claimed composition was
a pressure sensitive adhesive containing a tacky polymer while the
product of the reference was hard and abrasion resistant. "The Board
correctly found that the virtual identity of monomers and procedures
sufficed to support a prima facie case of unpatentability of Spada's
polymer latexes for lack of novelty.").

---SECTION---2112.02 Process Claims

PROCESS CLAIMS - PRIOR ART DEVICE ANTICIPATES A CLAIMED PROCESS IF THE
DEVICE CARRIES OUT THE PROCESS DURING NORMAL OPERATION

Under the principles of inherency, if a prior art device, in its normal
and usual operation, would necessarily perform the method claimed, then
the method claimed will be considered to be anticipated by the prior art
device. When the prior art device is the same as a device described in
the specification for carrying out the claimed method, it can be assumed
the device will inherently perform the claimed process. In re King, 801
F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986) (The claims were directed to a
method of enhancing color effects produced by ambient light through a
process of absorption and reflection of the light off a coated
substrate. A prior art reference to Donley disclosed a glass substrate
coated with silver and metal oxide 200-800 angstroms thick. While Donley
disclosed using the coated substrate to produce architectural colors,
the absorption and reflection mechanisms of the claimed process were not
disclosed. However, King's specification disclosed using a coated
substrate of Donley's structure for use in his process. The Federal
Circuit upheld the Board's finding that "Donley inherently performs the
function disclosed in the method claims on appeal when that device is
used in `normal and usual operation' " and found that a prima facie case
of anticipation was made out. Id. at 138, 801 F.2d at 1326. It was up to
applicant to prove that Donley's structure would not perform the claimed
method when placed in ambient light.).  See also In re Best, 562 F.2d
1252, 1255, 195 USPQ 430, 433 (CCPA 1977) (Applicant claimed a process
for preparing a hydrolytically-stable zeolitic aluminosilicate which
included a step of "cooling the steam zeolite ... at a rate sufficiently
rapid that the cooled zeolite exhibits a X-ray diffraction pattern ...."
All the process limitations were expressly disclosed by a U.S. patent to
Hansford except the cooling step. The court stated that any sample of
Hansford's zeolite would necessarily be cooled to facilitate subsequent
handling. Therefore, a   prima facie case under  35 U.S.C. 102/103 was
made. Applicant had failed to introduce any evidence comparing X-ray
diffraction patterns showing a difference in cooling rate between the
claimed process and that of Hansford or any data showing that the
process of Hansford would result in a product with a different X-ray
diffraction. Either type of evidence would have rebutted the prima facie
case under  35 U.S.C. 102. A further analysis would be necessary to
determine if the process was unobvious under  35 U.S.C. 103.); Ex parte
Novitski, 26 USPQ2d 1389 (Bd. Pat. App. & Inter. 1993) (The Board
rejected a claim directed to a method for protecting a plant from plant
pathogenic nematodes by inoculating the plant with a nematode inhibiting
strain of P. cepacia. A U.S. patent to Dart disclosed inoculation using
P. cepacia type Wisconsin 526 bacteria for protecting the plant from
fungal disease. Dart was silent as to nematode inhibition but the Board
concluded that nematode inhibition was an inherent property of the
bacteria. The Board noted that applicant had stated in the specification
that Wisconsin 526 possesses an 18% nematode inhibition rating.).

PROCESS OF USE CLAIMS - NEW AND UNOBVIOUS USES OF OLD STRUCTURES AND
COMPOSITIONS MAY BE PATENTABLE

The discovery of a new use for an old structure based on unknown
properties of the structure might be patentable to the discoverer as a
process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA
1957). However, when the claim recites using an old composition or
structure and the "use" is directed to a result or property of that
composition or structure, then the claim is anticipated. In re May, 574
F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978) (Claims 1 and 6, directed
to a method of effecting nonaddictive analgesia (pain reduction) in
animals, were found to be anticipated by the applied prior art which
disclosed the same compounds for effecting analgesia but which was
silent as to addiction. The court upheld the rejection and stated that
the applicants had merely found a new property of the compound and such
a discovery did not constitute a new use. The court went on to reverse
the rejection of claims 2-5 and 7-10 which recited a process of using a
new compound. The court relied on evidence showing that the nonaddictive
property of the new compound was unexpected.).

See also   In re Tomlinson, 363 F.2d 928, 150 USPQ 623 (CCPA 1966) (The
claim was directed to a process of inhibiting light degradation of
polypropylene by mixing it with one of a genus of compounds, including
nickel dithiocarbamate. A reference taught mixing polypropylene with
nickel dithiocarbamate to lower heat degradation. The court held that
the claims read on the obvious process of mixing polypropylene with the
nickel dithiocarbamate and that the preamble of the claim was merely
directed to the result of mixing the two materials. "While the
references do not show a specific recognition of that result, its
discovery by appellants is tantamount only to finding a property in the
old composition." 363 F.2d at 934, 150 USPQ at 628 (emphasis in
original).).

---SECTION---2113 Product-by-Process Claims

PRODUCT-BY-PROCESS CLAIMS ARE NOT LIMITED TO THE MANIPULATIONS OF THE
RECITED STEPS, ONLY THE STRUCTURE IMPLIED BY THE STEPS

"[E]ven though product-by process claims are limited by and defined by
the process, determination of patentability is based on the product
itself. The patentability of a product does not depend on its method of
production. If the product in the product-by-process claim is the same
as or obvious from a product of the prior art, the claim is unpatentable
even though the prior product was made by a different process."   In re
Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations
omitted) (Claim was directed to a novolac color developer. The process
of making the developer was allowed. The difference between the
inventive process and the prior art was the addition of metal oxide and
carboxylic acid as separate ingredients instead of adding the more
expensive pre-reacted metal carboxylate. The product-by-process claim
was rejected because the end product, in both the prior art and the
allowed process, ends up containing metal carboxylate. The fact that the
metal carboxylate is not directly added, but is instead produced in-situ
does not change the end product.).

ONCE A PRODUCT APPEARING TO BE SUBSTANTIALLY IDENTICAL IS FOUND AND A 35
U.S.C. 102/103 REJECTION MADE, THE BURDEN SHIFTS TO THE APPLICANT TO
SHOW AN UNOBVIOUS DIFFERENCE

"The Patent Office bears a lesser burden of proof in making out a case
of   prima facie obviousness for product-by-process claims because of
their peculiar nature" than when a product is claimed in the
conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324,
326 (CCPA 1974). Once the Examiner provides a rationale tending to show
that the claimed product appears to be the same or similar to that of
the prior art, although produced by a different process, the burden
shifts to applicant to come forward with evidence establishing an
unobvious difference between the claimed product and the prior art
product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir.
1983) (The claims were directed to a zeolite manufactured by mixing
together various inorganic materials in solution and heating the
resultant gel to form a crystalline metal silicate essentially free of
alkali metal. The prior art described a process of making a zeolite
which, after ion exchange to remove alkali metal, appeared to be
"essentially free of alkali metal." The court upheld the rejection
because the applicant had not come forward with any evidence that the
prior art was not "essentially free of alkali metal" and therefore a
different and unobvious product.).

Ex parte Gray, 10 USPQ2d 1922 (Bd. Pat. App. & Inter. 1989) (The prior
art disclosed human nerve growth factor (b-NGF) isolated from human
placental tissue. The claim was directed to b-NGF produced through
genetic engineering techniques. The factor produced seemed to be
substantially the same whether isolated from tissue or produced through
genetic engineering. While the applicant questioned the purity of the
prior art factor, no concrete evidence of an unobvious difference was
presented. The Board stated that the dispositive issue is whether the
claimed factor exhibits any unexpected properties compared with the
factor disclosed by the prior art. The Board further stated that the
applicant should have made some comparison between the two factors to
establish unexpected properties since the materials appeared to be
identical or only slightly different.).

THE USE OF 35 U.S.C. 102/103 REJECTIONS FOR PRODUCT-BY-PROCESS CLAIMS
HAS BEEN APPROVED BY THE COURTS

"[T]he lack of physical description in a product-by-process claim makes
determination of the patentability of the claim more difficult, since in
spite of the fact that the claim may recite only process limitations, it
is the patentability of the product claimed and not of the recited
process steps which must be established. We are therefore of the opinion
that when the prior art discloses a product which reasonably appears to
be either identical with or only slightly different than a product
claimed in a product-by-process claim, a rejection based alternatively
on either section 102 or section 103 of the statute is eminently fair
and acceptable. As a practical matter, the Patent Office is not equipped
to manufacture products by the myriad of processes put before it and
then obtain prior art products and make physical comparisons therewith."
In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).

---SECTION---2114 Apparatus and Article Claims - Functional Language

For a discussion of case law which provides guidance in interpreting the
functional portion of means-plus-function limitations see MPEP Section 
2181 -  Section  2186.

APPARATUS CLAIMS MUST BE STRUCTURALLY DISTINGUISHABLE FROM THE PRIOR ART

Claims directed to apparatus must be distinguished from the prior art in
terms of structure rather than function. In re Danly, 263 F.2d 844, 847,
120 USPQ 528, 531 (CCPA 1959). "[A]pparatus claims cover what a device  
is, not what a device   does."(emphasis in original) Hewlett-Packard Co.
v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed.
Cir. 1990).

MANNER OF OPERATING THE DEVICE DOES NOT DIFFERENTIATE APPARATUS CLAIM
FROM THE PRIOR ART

A claim containing a "recitation with respect to the manner in which a
claimed apparatus is intended to be employed does not differentiate the
claimed apparatus from a prior art apparatus" if the prior art apparatus
teaches all the structural limitations of the claim. Ex parte Masham, 2
USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) (The preamble of claim 1
recited that the apparatus was "for mixing flowing developer material"
and the body of the claim recited "means for mixing ..., said mixing
means being stationary and completely submerged in the developer
material". The claim was rejected over a reference which taught all the
structural limitations of the claim for the intended use of mixing
flowing developer. However, the mixer was only partially submerged in
the developer material. The Board held that the amount of submersion is
immaterial to the structure of the mixer and thus the claim was properly
rejected.).

A PRIOR ART DEVICE CAN PERFORM ALL THE FUNCTIONS OF THE APPARATUS CLAIM
AND STILL NOT ANTICIPATE THE CLAIM

Even if the prior art device performs all the functions recited in the
claim, the prior art cannot anticipate the claim if there is any
structural difference. It should be noted, however, that means plus
function limitations are met by structures which are equivalent to the
corresponding structures recited in the specification. In re Ruskin, 347
F.2d 843, 146 USPQ 211 (CCPA 1965) as implicitly modified by   In re
Donaldson, 16 F.3d 1189, 29 USPQ2d 1845 (Fed. Cir. 1994).

---SECTION---2115 Material or Article Worked Upon by Apparatus

MATERIAL OR ARTICLE WORKED UPON DOES NOT LIMIT APPARATUS CLAIMS

"Expressions relating the apparatus to contents thereof during an
intended operation are of no significance in determining patentability
of the apparatus claim." Ex parte Thibault, 164 USPQ 666, 667 (Bd. App.
1969). Furthermore, "Inclusion of material or article worked upon by a
structure being claimed does not impart patentability to the claims." In
re Young, 75 F.2d 966, 25 USPQ 69 (CCPA 1935) (as restated in   In re
Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)).

In   In re Young, a claim to a machine for making concrete beams
included a limitation to the concrete reinforced members made by the
machine as well as the structural elements of the machine itself. The
court held that the inclusion of the article formed within the body of
the claim did not, without more, make the claim patentable.

In   In re Casey, 370 F.2d 576, 152 USPQ 235 (CCPA 1967), an apparatus
claim recited "A taping machine comprising a supporting structure, a
brush attached to said supporting structure, said brush being formed
with projecting bristles which terminate in free ends to collectively
define a surface to which adhesive tape will detachably adhere, and
means for providing relative motion between said brush and said
supporting structure while said adhesive tape is adhered to said
surface." An obviousness rejection was made over a reference to Kienzle
which taught a machine for perforating sheets. The court upheld the
rejection stating that "the references in claim 1 to adhesive tape
handling do not expressly or impliedly require any particular structure
in addition to that of Kienzle." The perforating device had the
structure of the taping device as claimed, the difference was in the use
of the device, and "the manner or method in which such machine is to be
utilized is not germane to the issue of patentability of the machine
itself."

Note that this line of cases is limited to claims directed to machinery
which works upon an article or material in its intended use, it does not
apply to product claims or kit claims (i.e., claims directed to a
plurality of articles grouped together as a kit).

---SECTION---2116 Material Manipulated in Process

The materials on which a process is carried out must be accorded weight
in determining the patentability of a process. Ex parte Leonard, 187
USPQ 122 (Bd. App. 1974).

---SECTION---2116.01 Novel, Unobvious Starting Material or End Product

All the limitations of a claim must be considered when weighing the
differences between the claimed invention and the prior art in
determining the obviousness of a process or method claim.  See MPEP
Section  2143.03.

In re Ochiai, 71 F.3d 1565, 37 USPQ2d 1127 (Fed. Cir. 1995) and In re
Brouwer, 77 F.3d 422, 37 USPQ2d 1663 (Fed. Cir. 1996) addressed the
issue of whether an otherwise conventional process could be patented if
it were limited to making or using a nonobvious product.  In both cases,
the Federal Circuit held that the use of per se rules is improper in
applying the test for obviousness under  35 U.S.C. 103.  Rather,  35
U.S.C. 103 requires a highly fact-dependent analysis involving taking
the claimed subject matter as a whole and comparing it to the prior art. 
To support a rejection under  35 U.S.C. 103, the collective teachings of
the prior art must have suggested to one of ordinary skill in the art
that, at the time the invention was made, applicant's claimed invention
would have been obvious.  In applying this test to the claims on appeal
in Ochiai and Brouwer, the court held that there simply was no
suggestion or motivation in the prior art to make or use novel,
nonobvious products in the claimed processes.  Consequently, the court
overturned the rejections based upon  35 U.S.C. 103.

Interpreting the claimed invention as a whole requires consideration of
all claim limitations.  Thus, proper claim construction requires
treating language in a process claim which recites the making or using
of a nonobvious product as a material limitation. Motivation to make or
use the nonobvious product must be present in the prior art for a  35
U.S.C. 103 rejection to be sustained. The decision in Ochiai
specifically dispelled any distinction between processes of making a
product and methods of using a product with regard to the effect of any
product limitations in either type of claim.

As noted in Brouwer, 77 F.3d at 425, 37 USPQ2d at 1666, the inquiry as
to whether a claimed invention would have been obvious is "highly
fact-specific by design".  Accordingly, obviousness must be assessed on
a case-by-case basis.  The following decisions are illustrative of the
lack of   per se rules in applying the test for obviousness under  35
U.S.C. 103 and of the fact intensive comparison of claimed processes
with the prior art: In re Durden, 763 F.2d 1406, 226 USPQ 359 (Fed. Cir.
1985) (The examiner rejected a claim directed to a process in which
patentable starting materials were reacted to form patentable end
products. The prior art showed the same chemical reaction mechanism
applied to other chemicals.  The court held that the process claim was
obvious over the prior art.); In re Albertson, 332 F.2d 379, 141 USPQ
730 (CCPA 1964)(Process of chemically reducing one novel, nonobvious
material to obtain another novel, nonobvious material was claimed.  The
process was held obvious because the reduction reaction was old.); In re
Kanter, 399 F.2d 249, 158 USPQ 331 (CCPA 1968) (Process of siliconizing
a patentable base material to obtain a patentable product was claimed.
Rejection based on prior art teaching the siliconizing process as
applied to a different base material was upheld.);  Cf. In re
Pleuddemann, 910 F.2d 823, 15 USPQ2d 1738 (Fed. Cir. 1990) (Methods of
bonding polymer and filler using a novel silane coupling agent held
patentable even though methods of bonding using other silane coupling
agents were well known because the process could not be conducted
without the new agent); In re Kuehl, 475 F.2d 658, 177 USPQ 250 (CCPA
1973) (Process of cracking hydrocarbons using novel zeolite catalyst
found to be patentable even though catalytic cracking process was old.
"The test under  103 is whether in view of the prior art the invention
as a whole would have been obvious at the time it was made, and the
prior art here does not include the zeolite, ZK-22.  The obviousness of
the process of cracking hydrocarbons with ZK-22 as a catalyst must be
determined without reference to knowledge of ZK-22 and its properties." 
475 F.2d at 664-665, 177 USPQ at 255.); and In re Mancy, 499 F.2d 1289,
182 USPQ 303 (CCPA 1974) (Claim to a process for the production of a
known antibiotic by cultivating a novel, unobvious microorganism was
found to be patentable.).

---SECTION---2121 Prior Art; General Level of Operability Required to
Make a Prima Facie Case

PRIOR ART IS PRESUMED TO BE OPERABLE/ ENABLING

When the reference relied on expressly anticipates or makes obvious all
of the elements of the claimed invention, the reference is presumed to
be operable. Once such a reference is found, the burden is on applicant
to provide facts rebutting the presumption of operability. In re Sasse,
629 F.2d 675, 207 USPQ 107 (CCPA 1980). See also MPEP Section  716.07.

WHAT CONSTITUTES AN "ENABLING DISCLOSURE" DOES NOT DEPEND ON THE TYPE OF
PRIOR ART THE DISCLOSURE IS CONTAINED IN

The level of disclosure required within a reference to make it an
"enabling disclosure" is the same no matter what type of prior art is at
issue. It does not matter whether the prior art reference is a U.S.
patent, foreign patent, a printed publication or other. There is no
basis in the statute (35 U.S.C. 102 or 103) for discriminating either in
favor of or against prior art references on the basis of nationality. In
re Moreton, 288 F.2d 708, 129 USPQ 227 (CCPA 1961).

---SECTION---2121.01 Use of Prior Art in Rejections Where Operability Is
in Question

"In determining that quantum of prior art disclosure which is necessary
to declare an applicant's invention `not novel' or `anticipated' within
section 102, the stated test is whether a reference contains an
`enabling disclosure'... ."  In re Hoeksema, 399 F.2d 269, 158 USPQ 596
(CCPA 1968). A reference contains an "enabling disclosure" if the public
was in possession of the claimed invention before the date of invention.
"Such possession is effected if one of ordinary skill in the art could
have combined the publication's description of the invention with his
[or her] own knowledge to make the claimed invention." In re Donohue,
766 F.2d 531, 226 USPQ 619 (Fed. Cir. 1985).

I. 35 U.S.C. 102 REJECTIONS AND ADDITION OF EVIDENCE SHOWING REFERENCE
IS OPERABLE

It is possible to make a  35 U.S.C. 102 rejection even if the reference
does not itself teach one of ordinary skill how to practice the
invention, i.e., how to make or use the article disclosed. If the
reference teaches every claimed element of the article, secondary
evidence, such as other patents or publications, can be cited to show
public possession of the method of making and/or using. In re Donohue,
766 F.2d at 533, 226 USPQ at 621. See MPEP Section  2131.01 for more
information on  35 U.S.C. 102 rejections using secondary references to
show that the primary reference contains an "enabling disclosure."

II. 35 U.S.C. 103 REJECTIONS AND USE OF INOPERATIVE PRIOR ART

"Even if a reference discloses an inoperative device, it is prior art
for all that it teaches." Beckman Instruments v. LKB Produkter AB, 892
F.2d 1547, 1551, 13 USPQ2d 1301, 1304 (Fed. Cir. 1989). Therefore, "a
non-enabling reference may qualify as prior art for the purpose of
determining obviousness under  35 U.S.C. 103." Symbol Technologies Inc.
v. Opticon Inc., 935 F.2d 1569, 1578, 19 USPQ2d 1241, 1247 (Fed. Cir.
1991).

---SECTION---2121.02 Compounds and Compositions - What Constitutes
Enabling Prior Art

ONE OF ORDINARY SKILL IN THE ART MUST BE ABLE TO MAKE OR SYNTHESIZE

Where a process for making the compound is not developed until after the
date of invention, the mere naming of a compound in a reference, without
more, cannot constitute a description of the compound. In re Hoeksema,
399 F.2d 269, 158 USPQ 596 (CCPA 1968). Note, however, that a reference
is presumed operable until applicant provides facts rebutting the
presumption of operatibility. In re Sasse, 629 F.2d 675, 207 USPQ 107
(CCPA 1980). Therefore, applicant must provide evidence showing that a
process for making was not known at the time of the invention. See the
following paragraph for the evidentiary standard to be applied.

A REFERENCE DOES NOT CONTAIN AN "ENABLING DISCLOSURE" IF ATTEMPTS AT
MAKING THE COMPOUND OR COMPOSITION WERE UNSUCCESSFUL BEFORE THE DATE OF
INVENTION

When a prior art reference merely discloses the structure of the claimed
compound, evidence showing that attempts to prepare that compound were
unsuccessful before the date of invention will be adequate to show
inoperability. In re Wiggins, 488 F.2d 538, 179 USPQ 421 (CCPA 1971).
However, the fact that an author of a publication did not attempt to
make the compound disclosed, without more, will not overcome a rejection
based on that publication. In re Donohue, 766 F.2d 531, 226 USPQ 619
(Fed. Cir. 1985) (In this case, the examiner had made a rejection under 
35 U.S.C. 102(b) over a publication, which disclosed the claimed
compound, in combination with two patents teaching a general process of
making the particular class of compounds. The applicant submitted an
affidavit stating that the authors of the publication had not actually
synthesized the compound. The court held that the fact that the
publication's author did not synthesize the disclosed compound was
immaterial to the question of reference operability. The patents were
evidence that synthesis methods were well known. The court distinguished
Wiggins, in which a very similar rejection was reversed. In Wiggins,
attempts to make the compounds using the prior art methods were all
unsuccessful.). Compare   In re Hoeksema, 399 F.2d 269, 158 USPQ 596
(CCPA 1968) (A claim to a compound was rejected over a patent to De Boer
which disclosed compounds similar in structure to those claimed (obvious
homologs) and a process of making these compounds. Applicant responded
with an affidavit by an expert named Wiley which stated that there was
no indication in the De Boer patent that the process disclosed in De
Boer could be used to produce the claimed compound and that he did not
believe that the process disclosed in De Boer could be adapted to the
production of the claimed compound. The court held that the facts stated
in this affidavit were legally sufficient to overcome the rejection and
that applicant need not show that all known processes are incapable of
producing the claimed compound for this showing would be practically
impossible.).

---SECTION---2121.03 Plant Genetics - What Constitutes Enabling Prior
Art

THOSE OF ORDINARY SKILL MUST BE ABLE TO GROW AND CULTIVATE THE PLANT

When the claims are drawn to plants, the reference, combined with
knowledge in the prior art, must enable one of ordinary skill in the art
to reproduce the plant. In re LeGrice, 301 F.2d 929, 133 USPQ 365 (CCPA
1962) (National Rose Society Annual of England and various other
catalogues showed color pictures of the claimed roses and disclosed that
applicant had raised the roses. The publications were published more
than 1 year before applicant's filing date. The court held that the
publications did not place the rose in the public domain. Information on
the grafting process required to reproduce the rose was not included in
the publications and such information was necessary for those of
ordinary skill in the art (plant breeders) to reproduce the rose.).
Compare Ex parte Thompson, 24 USPQ2d 1618 (Bd. Pat. App. & Inter. 1992)
(Seeds were commercially available more than 1 year prior to applicant's
filing date. One of ordinary skill in the art could grow the claimed
cotton cultivar from the commercially available seeds. Thus, the
publications describing the cotton cultivar had "enabled disclosures."
The Board distinguished In re LeGrice by finding that the catalogue
picture of the rose of In re LeGrice was the only evidence in that case.
There was no evidence of commercial availability in enabling form since
the asexually reproduced rose could not be reproduced from seed.
Therefore, the public would not have possession of the rose by its
picture alone, but the public would have possession of the cotton
cultivar based on the publications and the availability of the seeds.).

---SECTION---2121.04 Apparatus and Articles - What Constitutes Enabling
Prior Art

PICTURES MAY CONSTITUTE AN "ENABLING DISCLOSURE"

Pictures and drawings may be sufficiently enabling to put the public in
the possession of the article pictured. Therefore, such an enabling
picture may be used to reject claims to the article. However, the
picture must show all the claimed structural features and how they are
put together. Jockmus v. Leviton, 28 F.2d 812 (2d Cir. 1928). See also
MPEP Section  2125 for a discussion of drawings as prior art.

---SECTION---2122 Discussion of Utility in the Prior Art

UTILITY NEED NOT BE DISCLOSED IN REFERENCE

In order to constitute anticipatory prior art, a reference must
identically disclose the claimed compound, but no utility need be
disclosed by the reference. In re Schoenwald, 964 F.2d 1122, 22 USPQ2d
1671 (Fed. Cir. 1992) (The application claimed compounds used in
ophthalmic compositions to treat dry eye syndrome. The examiner found a
printed publication which disclosed the claimed compound but did not
disclose a use for the compound. The court found that the claim was
anticipated since the compound and a process of making it was taught by
the reference. The court explained that "no utility need be disclosed
for a reference to be anticipatory of a claim to an old compound." 964
F.2d at 1124, 22 USPQ2d at 1673. It is enough that the claimed compound
is taught by the reference.).

---SECTION---2123 Rejection Over Prior Art's Broad Disclosure Instead of
Preferred Embodiments

PATENTS ARE RELEVANT AS PRIOR ART FOR ALL THEY CONTAIN

"The use of patents as references is not limited to what the patentees
describe as their own inventions or to the problems with which they are
concerned. They are part of the literature of the art, relevant for all
they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039
(Fed. Cir. 1983) (quoting   In re Lemelson, 397 F.2d 1006, 1009, 158
USPQ 275, 277 (CCPA 1968)).

A reference may be relied upon for all that it would have reasonably
suggested to one having ordinary skill the art, including nonpreferred
embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10
USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989).

NONPREFERRED EMBODIMENTS CONSTITUTE PRIOR ART

Disclosed examples and preferred embodiments do not constitute a
teaching away from a broader disclosure or nonpreferred embodiments. In
re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). "A known or obvious
composition does not become patentable simply because it has been
described as somewhat inferior to some other product for the same use."
In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994)
(The invention was directed to a an epoxy impregnated fiber-reinforced
printed circuit material. The applied prior art reference taught a
printed circuit material similar to that of the claims but impregnated
with polyester-imide resin instead of epoxy. The reference, however,
disclosed that epoxy was known for this use, but that epoxy impregnated
circuit boards have "relatively acceptable dimensional stability" and
"some degree of flexibility," but are inferior to circuit boards
impregnated with polyester-imide resins. The court upheld the rejection
concluding that, while the reference did teach away from using epoxy,
the "teaching away" was insufficient to overcome the rejection since
"Gurley asserted no discovery beyond what was known in the art." 27 F.3d
at 554, 31 USPQ2d at 1132.).

---SECTION---2124 Exception to the Rule That the Critical Reference Date
Must Precede the Filing Date

IN SOME CIRCUMSTANCES A FACTUAL REFERENCE NEED NOT ANTEDATE THE FILING
DATE

In certain circumstances, references cited to show a universal fact need
not be available as prior art before applicant's filing date. In re
Wilson, 311 F.2d 266, 135 USPQ 442 (CCPA 1962). Such facts include the
characteristics and properties of a material or a scientific truism.
Some specific examples in which later publications showing factual
evidence can be cited include situations where the facts shown in the
reference are evidence "that, as of an application's filing date, undue
experimentation would have been required,   In re Corneil, 347 F.2d 563,
568, 145 USPQ 702, 705 (CCPA 1965), or that a parameter absent from the
claims was or was not critical, In re Rainer, 305 F.2d 505, 507 n.3, 134
USPQ 343, 345 n.3 (CCPA 1962), or that a statement in the specification
was inaccurate, In re Marzocchi, 439 F.2d 220, 223 n.4, 169 USPQ 367,
370 n.4 (CCPA 1971), or that the invention was inoperative or lacked
utility, In re Langer, 503 F.2d 1380, 1391, 183 USPQ 288, 297 (CCPA
1974), or that a claim was indefinite,   In re Glass, 492 F.2d 1228,1232
n.6, 181 USPQ 31, 34 n.6 (CCPA 1974), or that characteristics of prior
art products were known,   In re Wilson, 311 F.2d 266, 135 USPQ 442
(CCPA 1962)." In re Koller, 613 F.2d 819, 823 n.5, 204 USPQ 702, 706 n.5
(CCPA 1980) (quoting   In re Hogan, 559 F.2d 595, 605 n.17, 194 USPQ
527, 537 n.17 (CCPA 1977) (emphasis in original)). However, it is
impermissible to use a later factual reference to determine whether the
application is enabled or described as required under  35 U.S.C. 112,
first paragraph. In re Koller, 613 F.2d 819, 823 n. 5, 204 USPQ 702, 706
n.5 (CCPA 1980). References which do not qualify as prior art because
they postdate the claimed invention may be relied upon to show the level
of ordinary skill in the art at or around the time the invention was
made. Ex parte Erlich, 22 USPQ 1463 (Bd. Pat. App. & Inter. 1992).

---SECTION---2125 Drawings as Prior Art

DRAWINGS CAN BE USED AS PRIOR ART

Drawings and pictures can anticipate claims if they clearly show the
structure which is claimed. In re Mraz, 455 F.2d 1069, 173 USPQ 25 (CCPA
1972). However, the picture must show all the claimed structural
features and how they are put together. Jockmus v. Leviton, 28 F.2d 812
(2d Cir. 1928). The origin of the drawing is immaterial. For instance,
drawings in a design patent can anticipate or make obvious the claimed
invention as can drawings in utility patents. When the reference is a
utility patent, it does not matter that the feature shown is unintended
or unexplained in the specification. The drawings must be evaluated for
what they reasonably disclose and suggest to one of ordinary skill in
the art. In re Aslanian, 590 F.2d 911, 200 USPQ 500 (CCPA 1979). See
MPEP Section  2121.04 for more information on prior art drawings as
"enabled disclosures."

PROPORTIONS OF FEATURES IN A DRAWING ARE NOT EVIDENCE OF ACTUAL
PROPORTIONS WHEN DRAWINGS ARE NOT TO SCALE

When the reference does not disclose that the drawings are to scale and
is silent as to dimensions, arguments based on measurement of the
drawing features are of little value. However, the description of the
article pictured can be relied on, in combination with the drawings, for
what they would reasonably teach one of ordinary skill in the art. In re
Wright, 569 F.2d 1124, 193 USPQ 332 (CCPA 1977) ("We disagree with the
Solicitor's conclusion, reached by a comparison of the relative
dimensions of appellant's and Bauer's drawing figures, that Bauer
`clearly points to the use of a chime length of roughly 1/2 to 1 inch
for a whiskey barrel.' This ignores the fact that Bauer does not
disclose that his drawings are to scale. ... However, we agree with the
Solicitor that Bauer's teaching that whiskey losses are influenced by
the distance the liquor needs to `traverse the pores of the wood'
(albeit in reference to the thickness of the barrelhead)" would have
suggested the desirability of an increased chime length to one of
ordinary skill in the art bent on further reducing whiskey losses." 569
F.2d at 1127, 193 USPQ at 335-36.)

---SECTION---2126 Availability of a Document as a "Patent" for Purposes
of Rejection Under 35 U.S.C. 102(a), (b), and (d)

THE NAME "PATENT" ALONE DOES NOT MAKE A DOCUMENT AVAILABLE AS A PRIOR
ART PATENT UNDER 35 U.S.C. 102(a) or (b)

What a foreign country designates to be a patent may not be a patent for
purposes of rejection under  35 U.S.C. 102(a) and (b); it is the
substance of the rights conferred and the way information within the
"patent" is controlled that is determinative. In re Ekenstam, 256 F.2d
321, 118 USPQ 349 (CCPA 1958). See the next paragraph for further
explanation with respect to when a document can be applied in a
rejection as a "patent." See MPEP Section  2135.01 for a further
discussion of the use of "patents" in  35 U.S.C. 102(d) rejections.

A SECRET PATENT IS NOT AVAILABLE AS A REFERENCE UNDER 35 U.S.C. 102(a)
or (b) UNTIL IT IS AVAILABLE TO THE PUBLIC BUT IT MAY BE AVAILABLE UNDER
35 U.S.C. 102(d) AS OF GRANT DATE

Secret patents are defined as patents which are insufficiently
accessible to the public to constitute "printed publications." Decisions
on the issue of what is sufficiently accessible to be a "printed
publication" are located in MPEP Section  2128 -  Section  2128.01.

Even if a patent grants an exclusionary right (is enforceable), it is
not available as prior art under  35 U.S.C. 102(a) or (b) if it is
secret or private. In re Carlson, 983 F.2d 1032, 1037, 25 USPQ2d 1207,
1211 (Fed. Cir. 1992). The document must be at least minimally available
to the public to constitute prior art. The patent is sufficiently
available to the public for the purposes of  35 U.S.C. 102(a) or (b) if
it is laid open for public inspection or disseminated in printed form. 
See, e.g., In re Carlson, 938 F.2d at 1037, 25 USPQ2d at 1211 ("We
recognize that   Geschmacksmuster on display for public view in remote
cities in a far-away land may create a burden of discovery for one
without the time, desire, or resources to journey there in person or by
agent to observe that which was registered under German law. Such a
burden, however, is by law imposed upon the hypothetical person of
ordinary skill in the art who is charged with knowledge of all contents
of the relevant prior art."). The date that the patent is made available
to the public is the date it is available as a  35 U.S.C. 102(a) or (b)
reference. In re Ekenstam, 256 F.2d 321, 118 USPQ 349 (CCPA 1958). But a
period of secrecy after granting the patent has been held to have no
effect in connection with 35 U.S.C 102(d). These patents are usable in
rejections under  35 U.S.C. 102(d) as of the date patent rights are
granted. In re Kathawala, 9 F.3d 942, 28 USPQ2d 1789 (Fed. Cir. 1993). 
See MPEP Section  2135 -  Section  2135.01 for more information on  35
U.S.C. 102(d).



---SECTION---2126.01 Date of Availability of a Patent As a Reference

DATE FOREIGN PATENT IS EFFECTIVE AS A REFERENCE IS USUALLY THE DATE
PATENT RIGHTS ARE FORMALLY AWARDED TO ITS APPLICANT

The date the patent is available as a reference is generally the date
that the patent becomes enforceable. This date is the date the sovereign
formally bestows patents rights to the applicant. In re Monks, 588 F.2d
308, 200 USPQ 129 (CCPA 1978). There is an exception to this rule when
the patent is secret as of the date the rights are awarded. In re
Ekenstam, 256 F.2d 321, 118 USPQ 349 (CCPA 1958).

Note that MPEP Section  901.05 summarizes in tabular form dates of
patenting for many foreign patents. Chisum, Patents Section  3.06[4] n.2
gives a good summary of decisions which specify reference availability
dates for specific classes of foreign patents. A copy of Chisum is kept
in the law library of the Solicitor's Office and in the Lutrelle F.
Parker, Sr., Memorial Law Library located in CPK1-520.

---SECTION---2126.02 Scope of Reference's Disclosure Which Can Be Used
to Reject Claims When the Reference Is a  "Patent" but Not a
"Publication"

OFTEN UNCLAIMED DETAILS FOUND IN THE PATENT SPECIFICATION CAN BE RELIED
ON EVEN IF PATENT IS SECRET

When the patented document is used as a patent and not as a publication,
the examiner is not restricted to the information conveyed by the patent
claims but may use any information provided in the specification which
relates to the subject matter of the patented claims when making a
rejection under  35 U.S.C. 102(a), (b) or (d). Ex parte Ovist, 152 USPQ
709, 710 (Bd. App. 1963) (The claim of an Italian patent was generic and
thus embraced the species disclosed in the examples, the Board added
that the entire specification was germane to the claimed invention and
upheld the examiner's  35 U.S.C. 102(b) rejection.); In re Kathawala, 9
F.3d 942, 28 USPQ2d 1785 (Fed. Cir. 1993) (The claims at issue where
rejected under  35 U.S.C. 102(d) by applicant's own parent applications
in Greece and Spain. The applicant argued that the "invention ...
patented' in Spain was not the same `invention' claimed in the U.S.
application because the Spanish patent claimed processes for making
[compounds for inhibition of cholesterol biosynthesis] and claims 1 and
2 were directed to the compounds themselves." 9 F.3d at 944, 28 USPQ2d
at 1786. The Federal Circuit held that "when an applicant files a
foreign application fully disclosing his invention and having the
potential to claim his invention in a number of ways, the reference in
section 102(d) to `invention ... patented' necessarily includes all
disclosed aspects of the invention."  9 F.3d at 945-46, 28 USPQ2d at
1789.)

In re Fuge, 272 F.2d 954, 957, 124 USPQ 105, 107 (CCPA 1959), does not
conflict with the above decisions. This decision simply states "that, at
the least, the scope of the patent embraces everything included in the
[claim]." (emphasis added).

Note that the courts have interpreted the phrase "invention ...
patented" in 102(a), (b), and (d) the same way and have cited decisions
without regard to which of these subsections of  35 U.S.C. 102 was at
issue in the particular case at hand. Therefore, it does not seem to
matter to which subsection of 102 the cases are directed; the court
decisions are interchangeable as to this issue.

---SECTION---2127 Domestic and Foreign Patent Applications as Prior Art

I. ABANDONED APPLICATIONS, INCLUDING PROVISIONAL APPLICATIONS

Abandoned Applications Disclosed to the Public Can Be Used as Prior Art

"An abandoned patent application may become evidence of prior art only
when it has been appropriately disclosed, as, for example, when the
abandoned patent [application] is reference[d] in the disclosure of
another patent, in a publication, or by voluntary disclosure under
[fomer Defensive Publication rule]  37 CFR 1.139."   Lee Pharmaceutical
v. Kreps, 577 F.2d 610, 613, 198 USPQ 601, 605 (9th Cir. 1978). An
abandoned patent application becomes available as prior art only as of
the date the public gains access to it. See  37 CFR 1.14(a)(3)(iv). 
However, the subject matter of an abandoned application, including both
provisional and nonprovisional applications, referred to in a prior art
U.S. patent may be relied on in a  35 U.S.C. 102(e) rejection based on
that patent if the disclosure of the abandoned application is actually
included or incorporated by reference in the patent. Compare   In re
Lund, 376 F.2d 982, 991, 153 USPQ 625, 633 (CCPA 1967) (The court
reversed a rejection over a patent which was a continuation-in-part of
an abandoned application. Applicant's filing date preceded the issue
date of the patent reference. The abandoned application contained
subject matter which was essential to the rejection but which was not
carried over into the continuation-in-part. The court held that the
subject matter of the abandoned application was not available to the
public as of either the parent's or the child's filing dates and thus
could not be relied on in the 102(e) rejection.). See also MPEP Section 
901.02. See MPEP Section  2136.02 and Section  2136.03 for the  35
U.S.C. 102(e) date of a U.S. patent claiming priority under  35 U.S.C.
119 or 120.

II. APPLICATIONS WHICH HAVE ISSUED INTO U.S. PATENTS

A 35 U.S.C 102(e) Rejection Cannot Rely on Matter Which Was Canceled
from the Application and Thus Did Not Get Published in the Issued Patent

Canceled matter in the application file of a U.S. patent cannot be
relied upon in a rejection under  35 U.S.C. 102(e). Ex Parte Stalego,
154 USPQ 52, 53 (Bd. App. 1966). The canceled matter only becomes
available as prior art as of the date the application issues into a
patent since this is the date the application file wrapper becomes
available to the public. In re Lund, 376 F.2d 982, 153 USPQ 625 (CCPA
1967). For more information on available prior art for use in  35 U.S.C.
102(e) rejections see MPEP Section  2136.02.

III. FOREIGN APPLICATIONS OPEN FOR PUBLIC INSPECTION (LAID OPEN
APPLICATIONS)

Laid Open Applications May Constitute "Published" Documents

When the specification is not issued in printed form but is announced in
an official journal and anyone can inspect or obtain copies, it is
sufficiently accessible to the public to constitute a "publication"
within the meaning of  35 U.S.C. 102(a) and (b). See   In re Wyer, 655
F.2d 221, 210 USPQ 790 (CCPA 1981).

Older cases have held that laid open patent applications are not
"published" and cannot constitute prior art. Ex parte Haller, 103 USPQ
332 (Bd. App. 1953). However, whether or not a document is "published"
for the purposes of  35 U.S.C. 102 and 103 depends on how accessible the
document is to the public. As technology has made reproduction of
documents easier, the accessibility of the laid open applications has
increased. Items provided in easily reproducible form have thus become
"printed publications" as the phrase is used in  35 U.S.C. 102. In re
Wyer, 655 F.2d 221, 226, 210 USPQ 790, 794 (CCPA 1981) (Laid open
Australian patent application held to be a "printed publication" even
though only the abstract was published because it was laid open for
public inspection, microfilmed, "diazo copies" were distributed to five
suboffices having suitable reproduction equipment and the diazo copies
were available for sale.). The contents of a foreign patent application
should not be relied upon as prior art until the date of publication
(i.e., the insertion into the laid open application) can be confirmed by
an examiner's review of a copy of the document.  See MPEP Section 
901.05.

IV. PENDING U.S. APPLICATIONS

As specified in  37 CFR 1.14(a), all pending U.S. applications are
preserved in confidence except for reissue applications and applications
in which a request to open the complete application to inspection by the
public has been granted by the Office (37 CFR 1.11(b)). However, if two
copending applications have a common assignee or inventor, a rejection
will be proper in some circumstances. For instance, when the claims
between the two applications are not independent or distinct, a
provisional double patenting rejection is made. See MPEP Section  804.
If the copending applications differ by at least one inventor and at
least one of the applications is obvious in view of the other, a
provisional rejection over  35 U.S.C. 102(e) or 103 is made. See MPEP
Section  706.02(f) and Section  706.02(k).

---SECTION---2128 "Printed Publications" as Prior Art

A REFERENCE IS A "PRINTED PUBLICATION" IF IT IS ACCESSIBLE TO THE PUBLIC

A reference is proven to be a "printed publication" "upon a satisfactory
showing that such document has been disseminated or otherwise made
available to the extent that persons interested and ordinarily skilled
in the subject matter or art, exercising reasonable diligence, can
locate it." In re Wyer, 655 F.2d 221, 210 USPQ 790 (CCPA 1981) (quoting
I.C.E. Corp. v. Armco Steel Corp., 250 F. Supp. 738, 743, 148 USPQ 537,
540 (SDNY 1966)) ("We agree that `printed publication' should be
approached as a unitary concept. The traditional dichotomy between
`printed' and `publication' is no longer valid. Given the state of
technology in document duplication, data storage, and data retrieval
systems, the `probability of dissemination' of an item very often has
little to do with whether or not it is `printed' in the sense of that
word when it was introduced into the patent statutes in 1836. In any
event, interpretation of the words `printed' and `publication' to mean
`probability of dissemination' and `public accessibility' respectively,
now seems to render their use in the phrase `printed publication'
somewhat redundant.") In re Wyer, 655 F.2d at 226, 210 USPQ at 794.

See also Carella v. Starlight Archery, 804 F.2d 135, 231 USPQ 644 (Fed.
Cir. 1986) (Starlight Archery argued that Carella's patent claims to an
archery sight were anticipated under  35 U.S.C. 102(a) by an
advertisement in a Wisconsin Bow Hunter Association (WBHA) magazine and
a WBHA mailer prepared prior to Carella's filing date. However, there
was no evidence as to when the mailer was received by any of the
addressees. Plus, the magazine had not been mailed until 10 days after
Carella's filing date. The court held that since there was no proof that
either the advertisement or mailer was accessible to any member of the
public before the filing date there could be no rejection under  35
U.S.C. 102(a).).

EXAMINER NEED NOT PROVE ANYONE ACTUALLY LOOKED AT THE DOCUMENT

One need not prove someone actually looked at a publication when that
publication is accessible to the public through a library or patent
office. See In re Wyer, 655 F.2d 221, 210 USPQ 790 (CCPA 1981); In re
Hall, 781 F.2d 897, 228 USPQ 453 (Fed. Cir. 1986).

---SECTION---2128.01 Level of Public Accessibility Required

A THESIS PLACED IN A UNIVERSITY LIBRARY MAY BE PRIOR ART IF SUFFICIENTLY
ACCESSIBLE TO THE PUBLIC

A doctoral thesis indexed and shelved in a library is sufficiently
accessible to the public to constitute prior art as a "printed
publication." In re Hall, 781 F.2d 897, 228 USPQ 453 (Fed. Cir. 1986).
Even if access to the library is restricted, a reference will constitute
a "printed publication" as long as a presumption is raised that the
portion of the public concerned with the art would know of the
invention. In re Bayer, 568 F.2d 1357, 196 USPQ 670 (CCPA 1978).

In   In re Hall, general library cataloging and shelving practices
showed that a doctoral thesis deposited in university library would have
been indexed, cataloged and shelved and thus available to the public
before the critical date. Compare   In re Cronyn, 890 F.2d 1158, 13
USPQ2d 1070 (Fed. Cir.1989) (The theses were shelved and indexed by
index cards filed alphabetically by student name and kept in a shoe box
in the chemistry library. The index cards only listed the student name
and title of the thesis. Two of three judges held that the students'
theses were not accessible to the public. The court reasoned that the
theses had not been either cataloged or indexed in a meaningful way
since thesis could only be found if the researcher's name was known, but
the name bears no relationship to the subject of the thesis. One judge,
however, held that the fact that the theses were shelved in the library
was enough to make them sufficiently accessible to the public. The
nature of the index was not determinative. This judge relied on prior
Board decisions (Gulliksen v. Halberg, 75 USPQ 252, 257 (Bd. App. 1937)
and   Ex parte Hershberger, 96 USPQ 54, 56 (Bd. App. 1952)), which held
that shelving a single copy in a public library makes the work a
"printed publication." It should be noted that these Board decisions
have not been expressly overruled but have been criticized in other
decisions. See   In re Tenney, 254 F.2d 619, 117 USPQ 348 (CCPA 1958)
(concurring opinion by J.Rich) (A document, of which there is but one
copy, whether it be handwritten, typewritten or on microfilm, may be
technically accessible to anyone who can find it. Such a document is not
"printed" in the sense that a printing press has been used to reproduce
the document. If only technical accessibility were required "logic would
require the inclusion within the term [printed] of all unprinted public
documents for they are all `accessible.' While some tribunals have gone
quite far in that direction, as in the `college thesis cases,' I feel
they have done so unjustifiably and on the wrong theory. Knowledge is
not in the possession of the public where there has been no
dissemination, as distinguished from technical accessibility..." The
real significance of the word "printed" is grounded in the " 
probability of wide circulation."). See also Deep Welding, Inc. v.
Sciaky Bros., 417 F.2d 1227, 163 USPQ 144 (7th Cir. 1969) (calling the
holding of   Ex parte Hershberger "extreme"). Compare   In re Bayer, 568
F.2d 1357, 196 USPQ 670 (CCPA 1978) (A reference will constitute a
"printed publication" as long as a presumption is raised that the
portion of the public concerned with the art would know of the invention
even if accessibility is restricted to only this part of the public. But
accessibility to applicant's thesis was restricted to only three members
of a graduate committee. There can be no presumption that those
concerned with the art would have known of the invention in this case.).

ORALLY PRESENTED PAPER CAN CONSTITUTE A "PRINTED PUBLICATION" IF WRITTEN
COPIES ARE AVAILABLE WITHOUT RESTRICTION

A paper which is orally presented in a forum open to all interested
persons constitutes a "printed publication" if written copies are
disseminated without restriction. Massachusetts Institute of Technology
v. AB Fortia, 774 F.2d 1104, 1109, 227 USPQ 428, 432 (Fed. Cir. 1985)
(Paper orally presented to between 50 and 500 persons at a scientific
meeting open to all persons interested in the subject matter, with
written copies distributed without restriction to all who requested, is
a printed publication. Six persons requested and obtained copies.).

INTERNAL DOCUMENTS INTENDED TO BE CONFIDENTIAL ARE NOT "PRINTED
PUBLICATIONS"

Documents and items only distributed internally within an organization
which are intended to remain confidential are not "printed publications"
no matter how many copies are distributed. In re George, 2 USPQ2d 1880
(Bd. Pat. App. & Inter. 1987) (Research reports disseminated in-house to
only those persons who understood the policy of confidentiality
regarding such reports are not printed publications even though the
policy was not specifically stated in writing.); Garret Corp. v. United
States, 422 F.2d 874, 878, 164 USPQ 521, 524 (Ct. Cl.1970) ("While
distribution to government agencies and personnel alone may not
constitute publication ... distribution to commercial companies without
restriction on use clearly does."); Northern Telecom Inc. v. Datapoint
Corp., 908 F.2d 931, 15 USPQ2d 1321 (Fed. Cir. 1990) (Four reports on
the AESOP-B military computer system which were not under security
classification were distributed to about fifty organizations involved in
the AESOP-B project. One document contained the legend "Reproduction or
further dissemination is not authorized." The other documents were of
the class that would contain this legend. The documents were housed in
Mitre Corporation's library. Access to this library was restricted to
those involved in the AESOP-B project. The court held that public access
was insufficient to make the documents "printed publications.").

---SECTION---2128.02 Date Publication Is Available as a Reference

DATE OF ACCESSIBILITY CAN BE SHOWN THROUGH EVIDENCE OF ROUTINE BUSINESS
PRACTICES

Evidence showing routine business practices can be used to establish the
date on which a publication became accessible to the public. Specific
evidence showing when the specific document actually became available is
not always necessary. Constant v. Advanced Micro-Devices, Inc., 848 F.2d
1560, 7 USPQ2d 1057 (Fed. Cir.), cert. denied, 988 U.S. 892 (1988)
(Court held that evidence submitted by Intel regarding undated
specification sheets showing how the company usually treated such
specification sheets was enough to show that the sheets were accessible
by the public before the critical date.); In re Hall, 781 F.2d 897, 228
USPQ 453 (Fed. Cir. 1986) (Librarian's affidavit establishing normal
time frame and practice for indexing, cataloging and shelving doctoral
theses established that the thesis in question would have been
accessible by the public before the critical date.).

A JOURNAL ARTICLE OR OTHER PUBLICATION BECOMES AVAILABLE AS PRIOR ART ON
DATE OF IT IS RECEIVED BY A MEMBER OF THE PUBLIC

A publication disseminated by mail is not prior art until it is received
by at least one member of the public. Thus, a magazine or technical
journal is effective as of its date of publication (date when first
person receives it) not the date it was mailed or sent to the publisher.
In re Schlittler, 234 F.2d 882, 110 USPQ 304 (CCPA 1956).

---SECTION---2129 Admissions as Prior Art

ADMISSIONS BY APPLICANT CONSTITUTE PRIOR ART

When applicant states that something is prior art, it is taken as being
available as prior art against the claims. Admitted prior art can be
used in obviousness rejections. In re Nomiya, 509 F.2d 566, 184 USPQ
607, 610 (CCPA 1975) (Figures in the application labeled "prior art"
held to be an admission that what was pictured was prior art relative to
applicant's invention.).

A JEPSON CLAIM RESULTS IN AN IMPLIED ADMISSION THAT PREAMBLE IS PRIOR
ART

The preamble elements in a Jepson-type claim (i.e., a claim of the type
discussed in  37 CFR 1.75(e); see MPEP Section  608.01(m)) "are
impliedly admitted to be old in the art, ... but it is only an implied
admission." In re Ehrreich, 590 F.2d 902, 909-910 200 USPQ 504, 510
(CCPA 1979) (emphasis in original) (citations omitted). See also  
Sjolund v. Musland, 847 F.2d 1573, 1577, 6 USPQ2d 2020, 2023 (Fed. Cir.
1988); Pentec, Inc. v. Graphic Controls Corp., 776 F.2d 309, 315, 227
USPQ 766, 770 (Fed. Cir. 1985); and Reading & Bates Construction Co. v.
Baker Energy Resources Corp., 748 F.2d 645, 650, 223 USPQ 1168, 1172
(Fed. Cir. 1984). Claims must be read in light of the specification.
Where the specification confirms that the subject matter of the preamble
was invented by another before applicant's invention, the preamble is
treated as prior art. However, certain art may be prior art to one
inventive entity, but not to the public in general. In re Fout, 675 F.2d
297, 300-301, 213 USPQ 532, 535-36 (CCPA 1982). This is the case when
applicant has made an improvement on his or her own prior invention. An
applicant's own foundational work should not, unless there is a
statutory bar, be treated as prior art solely because knowledge of this
work is admitted. Therefore, when applicant explains that the   Jepson
format is being used to avoid a double patenting rejection over their
own copending application, the implication that the pre amble is
admitted prior art is overcome. Reading & Bates Construction Co. v.
Baker Energy Resources Corp., 748 F.2d 645, 650, 223 USPQ 1168, 1172
(Fed. Cir. 1984). Compare In re Fout, 675 F.2d 297, 300-01, 213 USPQ
532, 535-36 (CCPA 1982) (The court held that the preamble was admitted
prior art because the specification explained that Paglaro, a different
inventor, had invented the subject matter described in the preamble.).

---SECTION---2131 Anticipation - Application of 35 U.S.C.  102(a), (b),
and (e)

35 U.S.C. 102 Conditions for patentability; novelty and loss of right to
patent.

A person shall be entitled to a patent unless -

(a) the invention was known or used by others in this country, or
patented or described in a printed publication in this or a foreign
country, before the invention thereof by the applicant for a patent, or

(b) the invention was patented or described in a printed publication in
this or a foreign country or in public use or on sale in this country,
more than one year prior to the date of application for patent in the
United States, or

(c) he has abandoned the invention, or

(d) the invention was first patented or caused to be patented, or was
the subject of an inventor's certificate, by the applicant or his legal
representatives or assigns in a foreign country prior to the date of the
application for patent in this country on an application for patent or
inventor's certificate filed more than twelve months before the filing
of the application in the United States, or

(e) the invention was described in a patent granted on an application
for patent by another filed in the United States before the invention
thereof by the applicant for patent, or on an international application
by another who has fulfilled the requirements of paragraphs (1), (2),
and (4) of section 371(c) of this title before the invention thereof by
the applicant for patent, or

(f) he did not himself invent the subject matter sought to be patented,
or (g) before the applicant's invention thereof the invention was made
in this country by another who had not abandoned, suppressed, or
concealed it. In determining priority of invention there shall be
considered not only the respective dates of conception and reduction to
practice of the invention, but also the reasonable diligence of one who
was first to conceive and last to reduce to practice, from a time prior
to conception by the other.

TO ANTICIPATE A CLAIM, THE REFERENCE MUST TEACH EVERY ELEMENT OF THE
CLAIM

"A claim is anticipated only if each and every element as set forth in
the claim is found, either expressly or inherently described, in a
single prior art reference." Verdegaal Bros. v. Union Oil Co. of
California, 814 F.2d 628, 631, 2 USPQ2d 1051, 1053 (Fed. Cir. 1987).
"The identical invention must be shown in as complete detail as is
contained in the ... claim." Richardson v. Suzuki Motor Co., 868 F.2d
1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be
arranged as required by the claim, but this is not an   ipsissimis
verbis test, i.e., identity of terminology is not required. In re Bond,
910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990). Note that, in some
circumstances, it is permissible to use multiple references in a  35
U.S.C. 102 rejection. See MPEP Section  2131.01.

---SECTION---2131.01 Multiple Reference 35 U.S.C. 102 Rejections

Normally, only one reference should be used in making a rejection under 
35 U.S.C. 102. However, a  35 U.S.C. 102 rejection over multiple
references has been held to be proper when the extra references are
cited to:

(A) Prove the primary reference contains an "enabled disclosure;"

(B) Explain the meaning of a term used in the primary reference; or

(C) Show that a characteristic not disclosed in the reference is
inherent.

See paragraphs I-III below for more explanation of each circumstance.

I. TO PROVE REFERENCE CONTAINS AN "ENABLED DISCLOSURE"

Extra References and Extrinsic Evidence Can Be Used To Show the Primary
Reference Contains an "Enabled Disclosure"

When the claimed composition or machine is disclosed identically by the
reference, an additional reference may be relied on to show that the
primary reference has an "enabled disclosure." In re Samour, 571 F.2d
559, 197 USPQ 1 (CCPA 1978) and   In re Donohue, 766 F.2d 531, 226 USPQ
619 (Fed. Cir. 1985) (Compound claims were rejected under  35 U.S.C.
102(b) over a publication in view of two patents. The publication
disclosed the claimed compound structure while the patents taught
methods of making compounds of that general class. The applicant argued
that there was no motivation to combine the references because no
utility was previously known for the compound and that the  35 U.S.C.
102 rejection over multiple references was improper. The court held that
the publication taught all the elements of the claim and thus motivation
to combine was not required. The patents were only submitted as evidence
of what was in the public's possession before applicant's invention.).

II. TO EXPLAIN THE MEANING OF A TERM USED IN THE PRIMARY REFERENCE

Extra References or Other Evidence Can Be Used to Show Meaning of a Term
Used in the Primary Reference

Extrinsic evidence may be used to explain but not expand the meaning of
terms and phrases used in the reference relied upon as anticipatory of
the claimed subject matter. In re Baxter Travenol Labs., 952 F.2d 388,
21 USPQ2d 1281 (Fed. Cir. 1991) (Baxter Travenol Labs. invention was
directed to a blood bag system incorporating a bag containing DEHP, an
additive to the plastic which improved the bag's red blood cell storage
capability. The examiner rejected the claims over a technical progress
report by Becker which taught the same blood bag system but did not
expressly disclose the presence of DEHP. The report, however, did
disclose using commercial blood bags. It also disclosed the blood bag
system as "very similar to [Baxter] Travenol's commercial two bag blood
container." Extrinsic evidence (depositions, declarations and   Baxter
Travenol's own admissions) showed that commercial blood bags, at the
time Becker's report was written, contained DEHP. Therefore, one of
ordinary skill in the art would have known that "commercial blood bags"
meant bags containing DEHP. The claims were thus held to be
anticipated.).

III. TO SHOW THAT A CHARACTERISTIC NOT DISCLOSED IN THE REFERENCE IS
INHERENT

Extra Reference or Evidence Can Be Used To Show an Inherent
Characteristic of the Thing Taught by the Primary Reference

"To serve as an anticipation when the reference is silent about the
asserted inherent characteristic, such gap in the reference may be
filled with recourse to extrinsic evidence. Such evidence must make
clear that the missing descriptive matter is necessarily present in the
thing described in the reference, and that it would be so recognized by
persons of ordinary skill." Continental Can Co. USA v. Monsanto Co., 948
F.2d 1264, 1268, 20 USPQ2d 1746, 1749 (Fed. Cir. 1991) (The court went
on to explain that "this modest flexibility in the rule that
`anticipation' requires that every element of the claims appear in a
single reference accommodates situations in which the common knowledge
of technologists is not recorded in the reference; that is, where
technological facts are known to those in the field of the invention,
albeit not known to judges." 948 F.2d at 1268, 20 USPQ at 1749-50.) Note
that, in other cases, the courts have held that there is no requirement
that those of ordinary skill in the art know of the inherent property.
See MPEP Section  2112 -  Section  2112.02 for case law on inherency.
Also note that the critical date of extrinsic evidence showing a
universal fact need not antedate the filing date. See MPEP Section 
2124.

---SECTION---2131.02 Genus-Species Situations

A SPECIES WILL ANTICIPATE A CLAIM TO A GENUS

"A generic claim cannot be allowed to an applicant if the prior art
discloses a species falling within the claimed genus." The species in
that case will anticipate the genus. In re Slayter, 276 F.2d 408, 411,
125 USPQ 345, 347 (CCPA 1960); In re Gosteli, 872 F.2d 1008, 10 USPQ2d
1614 (Fed. Cir. 1989) (Gosteli claimed a genus of 21 specific chemical
species of bicyclic thia-aza compounds in Markush claims. The prior art
reference applied against the claims disclosed two of the chemical
species. The parties agreed that the prior art species would anticipate
the claims unless applicant was entitled to his foreign priority date.).

A REFERENCE THAT CLEARLY NAMES THE CLAIMED SPECIES ANTICIPATES THE CLAIM
NO MATTER HOW MANY OTHER SPECIES ARE NAMED

A genus does not always anticipate a claim to a species within the
genus. However, when the species is clearly named, the species claim is
anticipated no matter how many other species are additionally named. Ex
parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990) (The claimed
compound was named in a reference which also disclosed 45 other
compounds. The Board held that the comprehensiveness of the listing did
not negate the fact that the compound claimed was specifically taught.
The Board compared the facts to the situation in which the compound was
found in the Merck Index, saying that "the tenth edition of the Merck
Index lists ten thousand compounds. In our view, each and every one of
those compounds is `described' as that term is used in 35 U.S.C. Section 
102(a), in that publication.").  Id. at 1718.  See also   In re
Sivaramakrishnan, 673 F.2d 1383, 213 USPQ 441 (CCPA 1982) (The claims
were directed to polycarbonate containing cadmium laurate as an
additive. The court upheld the Board's finding that a reference
specifically naming cadmium laurate as an additive amongst a list of
many suitable salts in polycarbonate resin anticipated the claims. The
applicant had argued that cadmium laurate was only disclosed as
representative of the salts and was expected to have the same properties
as the other salts listed while, as shown in the application, cadmium
laurate had unexpected properties. The court held that it did not matter
that the salt was not disclosed as being preferred, the reference still
anticipated the claims and because the claim was anticipated, the
unexpected properties were immaterial.).

A GENERIC CHEMICAL FORMULA WILL ANTICIPATE A CLAIMED SPECIES COVERED BY
THE FORMULA WHEN THE SPECIES CAN BE "AT ONCE ENVISAGED" FROM THE FORMULA

When the compound is not specifically named, but instead it is necessary
to select portions of teachings within a reference and combine them,
e.g., select various substituents from a list of alternatives given for
placement at specific sites on a generic chemical formula to arrive at a
specific composition, anticipation can only be found if the classes of
substituents are sufficiently limited or well delineated. Ex parte A, 17
USPQ2d 1716 (Bd. Pat. App. & Inter. 1990). If one of ordinary skill in
the art is able to "at once envisage" the specific compound within the
generic chemical formula, the compound is anticipated. One of ordinary
skill in the art must be able to draw the structural formula or write
the name of each of the compounds included in the generic formula before
any of the compounds can be "at once envisaged." One may look to the
preferred embodiments to determine which compounds can be anticipated.
In re Petering, 301 F.2d 676, 133 USPQ 275 (CCPA 1962).

In   In re Petering, the prior art disclosed a generic chemical formula
"wherein X, Y, Z, P, and R4- represent either hydrogen or alkyl
radicals, R a side chain containing an OH group."  The court held that
this formula, without more, could not anticipate a claim to
7-methyl-9-[d, l4-ribityl]-isoalloxazine because the generic formula
encompassed a vast number and perhaps even an infinite number of
compounds. However, the reference also disclosed preferred substituents
for X, Y, Z, R, and R' as follows: where X, P, and R' are hydrogen,
where Y and Z may be hydrogen or methyl, and where R is one of eight
specific isoalloxazines. The court determined that this more limited
generic class consisted of about 20 compounds. The limited number of
compounds covered by the preferred formula in combination with the fact
that the number of substituents was low at each site, the ring positions
were limited, and there was a large unchanging structural nucleus,
resulted in a finding that the reference sufficiently described "each of
the various permutations here involved as fully as if he had drawn each
structural formula or had written each name." The claimed compound was 1
of these 20 compounds. Therefore, the reference "described" the claimed
compound and the reference anticipated the claims.

In In re Schauman, 572 F.2d 312, 197 USPQ 5 (CCPA 1978), claims to a
specific compound were anticipated because the prior art taught a
generic formula embracing a limited number of compounds closely related
to each other in structure and the properties possessed by the compound
class of the prior art was that disclosed for the claimed compound. The
broad generic formula seemed to describe an infinite number of compounds
but claim 1 was limited to a structure with only one variable
substituent R. This substituent was limited to low alkyl radicals. One
of ordinary skill in the art would at once envisage the subject matter
within claim 1 of the reference.).

Compare   In re Meyer, 599 F.2d 1026, 202 USPQ 175 (CCPA 1979) (A
reference disclosing "alkaline chlorine or bromine solution" embraces a
large number of spe cies and cannot be said to anticipate claims to
"alkali metal hypochlorite."); Akzo N.V. v. International Trade Comm'n,
808 F.2d 1471, 1 USPQ2d 1241 (Fed. Cir. 1986) (Claims to a process for
making aramid fibers using a 98% solution of sulfuric acid were not
anticipated by a reference which disclosed using sulfuric acid solution
but which did not disclose using a 98% concentrated sulfuric acid
solution.). See MPEP Section  2144.08 for a discussion of obviousness in
genus-species situations.

---SECTION---2131.03 Anticipation of Ranges

A SPECIFIC EXAMPLE IN THE PRIOR ART WHICH IS WITHIN A CLAIMED RANGE
ANTICIPATES THE RANGE

"[W]hen, as by a recitation of ranges or otherwise, a claim covers
several compositions, the claim is `anticipated' if one of them is in
the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ
773 (Fed. Cir. 1985) (citing In re Petering, 301 F.2d 676, 682, 133 USPQ
275, 280 (CCPA 1962))(emphasis in original) (Claims to titanium (Ti)
alloy with 0.6-0.9% nickel (Ni) and 0.2-0.4% molybdenum (Mo) were held
anticipated by a graph in a Russian article on Ti-Mo-Ni alloys because
the graph contained an actual data point corresponding to a Ti alloy
containing 0.25% Mo and 0.75% Ni and this composition was within the
claimed range of compositions.).

PRIOR ART WHICH TEACHES A RANGE WITHIN, OVERLAPPING, OR TOUCHING THE
CLAIMED RANGE ANTICIPATES IF THE PRIOR ART RANGE DISCLOSES THE CLAIMED
RANGE WITH "SUFFICIENT SPECIFICITY"

When the prior art discloses a range which touches, overlaps or is
within the claimed range, but no specific examples falling within the
claimed range are disclosed, a case by case determination must be made
as to anticipation. In order to anticipate the claims, the claimed
subject matter must be disclosed in the reference with "sufficient
specificity to constitute an anticipation under the statute." What
constitutes a "sufficient specificity" is fact dependent. If the claims
are directed to a narrow range, the reference teaches a broad range, and
there is evidence of unexpected results within the claimed narrow range,
depending on the other facts of the case, it may be reasonable to
conclude that the narrow range is not disclosed with "sufficient
specificity" to constitute an anticipation of the claims. The unexpected
results may also render the claims unobvious.  The question of
"sufficient specificity" is similar to that of "clearly envisaging" a
species from a generic teaching. See MPEP Section  2131.02. A  35 U.S.C.
102/103 combination rejection is permitted if it is unclear if the
reference teaches the range with "sufficient specificity." The examiner
must, in this case, provide reasons for anticipation as well as a
motivational statement regarding obviousness. Ex parte Lee 31 USPQ2d
1105 (Bd. Pat. App. & Inter. 1993) (expanded Board). For a discussion of
the obviousness of ranges see MPEP Section  2144.05.

---SECTION---2131.04 Secondary Considerations

Evidence of secondary considerations, such as unexpected results or
commercial success, is irrelevant to  35 U.S.C. 102 rejections and thus
cannot overcome a rejection so based. In re Wiggins, 488 F.2d 538, 543,
179 USPQ 421, 425 (CCPA 1973).

---SECTION---2131.05 Nonanalogous Art

"Arguments that the alleged anticipatory prior art is `nonanalogous art'
or `teaches away from the invention' or is not recognized as solving the
problem solved by the claimed invention, [are] not `germane' to a
rejection under section 102." Twin Disc, Inc. v. United States, 231 USPQ
417, 424 (Cl. Ct. 1986) (quoting In re Self, 671 F.2d 1344, 213 USPQ 1,
7 (CCPA 1982)).

---SECTION---2132 35 U.S.C. 102(a)

35 U.S.C. 102 Conditions for patentability; novelty and loss of right to
patent.

A person shall be entitled to a patent unless -

(a) the invention was known or used by others in this country, or
patented or described in a printed publication in this or a foreign
country, before the invention thereof by the applicant for a patent.

                  +++    

I. "KNOWN OR USED"

 "Known or Used" Means Publicly Known or Used

"The statutory language `known or used by others in this country' (35
U.S.C. Section  102(a)), means knowledge or use which is accessible to
the public." Carella v. Starlight Archery, 804 F.2d 135, 231 USPQ 644
(Fed. Cir. 1986). The knowledge or use is accessible to the public if
there has been no deliberate attempt to keep it secret. W. L. Gore &
Assoc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983).

See MPEP Section  2128 -  Section  2128.02 for case law concerning
public accessibility of publications.

Another's Sale of a Product Made by a Secret Process Can Be a 35 U.S.C.
102(a) Public Use if the Process Can Be Determined by Examining the
Product

"The nonsecret use of a claimed process in the usual course of producing
articles for commercial purposes is a public use." But a secret use of
the process coupled with the sale of the product does not result in a
public use of the process unless the public could learn the claimed
process by examining the product. Therefore, secret use of a process by
another, even if the product is commercially sold, cannot result in a
rejection under  35 U.S.C. 102(a) if an examination of the product would
not reveal the process.   Id.

II. "IN THIS COUNTRY"

Only Knowledge or Use in the U.S. Can Be Used in a 35 U.S.C. 102(a)
Rejection

The knowledge or use relied on in a  35 U.S.C. 102(a) rejection must be
knowledge or use "in this country." Prior knowledge or use which is not
present in the United States, even if widespread in a foreign country,
cannot be the basis of a rejection under  35 U.S.C. 102(a). In re
Ekenstam,  256 F.2d 321, 118 USPQ 349 (CCPA 1958). Note that the changes
made to  35 U.S.C. 104 by NAFTA (Public Law 103-182) and Uruguay Round
Agreements Act (Public Law 103-465) do not modify the meaning of "in
this country" as used in  35 U.S.C. 102(a) and thus "in this country"
still means in the United States for purposes of  35 U.S.C. 102(a)
rejections.

III. "BY OTHERS"

 "Others" Means Any Combination of Authors or Inventors Different Than
the Inventive Entity

The term "others" in  35 U.S.C. 102(a) refers to any entity which is
different from the inventive entity. The entity need only differ by one
person to be "by others." This holds true for all types of references
eligible as prior art under  35 U.S.C. 102(a) including publications as
well as public knowledge and use. Any other interpretation of  35 U.S.C.
102(a) "would negate the one year [grace] period afforded under Section 
102(b)." In re Katz, 687 F.2d 450, 215 USPQ 14 (CCPA 1982).

IV. "PATENTED IN THIS OR A FOREIGN COUNTRY"

See MPEP Section  2126 for information on the use of secret patents as
prior art.

---SECTION---2132.01 Publications as 35 U.S.C. 102(a) Prior Art

 35 U.S.C. 102(a) PRIMA FACIE CASE IS ESTABLISHED IF REFERENCE
PUBLICATION IS "BY OTHERS"

A prima facie case is made out under  35 U.S.C. 102(a) if, within 1 year
of the filing date, the invention, or an obvious variant thereof, is
described in a "printed publication" whose authorship differs in any way
from the inventive entity unless it is stated within the publication
itself that the publication is describing the applicant's work. In re
Katz, 687 F.2d 450, 215 USPQ 14 (CCPA 1982). See MPEP Section  2128 for
case law on what constitutes a "printed publication." Note that when the
reference is a U.S. patent published within the year prior to the
application filing date, a  35 U.S.C. 102(e) rejection should be made.
See MPEP Section  2136-  Section  2136.05 for case law dealing with
102(e).

APPLICANT CAN REBUT PRIMA FACIE CASE BY SHOWING REFERENCE'S DISCLOSURE
WAS DERIVED FROM APPLICANT'S OWN WORK

Applicant's disclosure of his or her own work within the year before the
application filing date cannot be used against him or her under  35
U.S.C. 102(a). In re Katz, 687 F.2d 450, 215 USPQ 14 (CCPA 1982)
(discussed below). Therefore, where the applicant is one of the
co-authors of a publication cited against his or her application, the
publication may be removed as a reference by the filing of affidavits
made out by the other authors establishing that the relevant portions of
the publication originated with, or were obtained from, applicant. Such
affidavits are called disclaiming affidavits.   Ex parte Hirschler, 110
USPQ 384 (Bd. App. 1952). The rejection can also be overcome by
submission of a specific declaration by the applicant establishing that
the article is describing applicant's own work.   In re Katz, 687 F.2d
450, 215 USPQ 14 (CCPA 1982). However, if there is evidence that the
co-author has refused to disclaim inventorship and believes himself or
herself to be an inventor, applicant's affidavit will not be enough to
establish that applicant is the sole inventor and the rejection will
stand. Ex parte Kroger, 219 USPQ 370 (Bd. Pat. App. & Int. 1982)
(discussed below). It is also possible to overcome the rejection by
adding the coauthors as inventors to the application if the requirements
of  35 U.S.C. 116, third paragraph are met.   In re Searles, 422 F.2d
431, 164 USPQ 623 (CCPA 1970).

In   In re Katz, 687 F.2d 450, 215 USPQ 14 (CCPA 1982), Katz stated in a
declaration that the coauthors of the publication, Chiorazzi and Eshhar,
"were students working under the direction and supervision of the
inventor, Dr. David H. Katz." The court held that this declaration, in
combination with the fact that the publication was a research paper, was
enough to establish Katz as the sole inventor and that the work
described in the publication was his own. In research papers, students
involved only with assay and testing are normally listed as coauthors
but are not considered co-inventors.

In Ex parte Kroger, 219 USPQ 370 (Bd. Pat. App. & Inter. 1982), Kroger,
Knaster and others were listed as authors on an article on photovoltaic
power generation. The article was used to reject the claims of an
application listing Kroger   and   Rod as inventors. Kroger   and Rod
submitted affidavits declaring themselves to be the inventors. The
affidavits also stated that Knaster merely carried out assignments and
worked under the supervision and direction of Kroger. The Board stated
that if this were the only evidence in the case, it would be
established, under   In re Katz, that Kroger and Rod were the only
inventors. However, in this case, there was evidence that Knaster had
refused to sign an affidavit disclaiming inventorship and Knaster had
introduced evidence into the case in the form of a letter to the PTO in
which he alleged that he was a co-inventor. The Board held that the
evidence had not been fully developed enough to overcome the rejection.
Note that the rejection had been made under  35 U.S.C. 102(f) but the
Board treated the issue the same as if it had arisen under  35 U.S.C.
102(a). See also case law dealing with overcoming 102(e) rejections as
presented in MPEP Section  2136.05. Many of the issues are the same.

A RULE 131 AFFIDAVIT CAN BE USED TO OVERCOME A 35 U.S.C. 102(a)
REJECTION

When the reference is not a statutory bar under  35 U.S.C. 102(b), (c),
or (d), applicant can overcome the rejection by swearing back of the
reference through the submission of an affidavit under  37 CFR 1.131. In
re Foster, 343 F.2d 980, 145 USPQ 166 (CCPA 1965). If the reference is
disclosing applicant's own work as derived from him or her, applicant
may submit either a  37 CFR 1.131 affidavit to antedate the reference or
a  37 CFR 1.132 affidavit to show derivation of the reference subject
matter from applicant and invention by applicant. In re Facius, 408 F.2d
1396, 161 USPQ 294 (CCPA 1969). See MPEP Section  715 for more
information on when an affidavit under  37 CFR 1.131 can be used to
overcome a reference and what evidence is required.

---SECTION---2133 35 U.S.C. 102(b)

35 U.S.C. 102 Conditions for patentability; novelty and loss of right to
patent.

A person shall be entitled to a patent unless -

                  +++    

(b) the invention was patented or described in a printed publication in
this or a foreign country or in public use or on sale in this country,
more than one year prior to the date of application for patent in the
United States.

                  +++    

THE 1-YEAR GRACE PERIOD IS EXTENDED TO THE NEXT WORKING DAY IF IT WOULD
OTHERWISE END ON A HOLIDAY OR WEEKEND

Publications, patents, public uses and sales must occur "more than one
year prior to the date of application for patent in the United States"
in order to bar a patent under  35 U.S.C. 102(b). However, applicant's
own activity will not bar a patent if the 1-year grace period expires on
a Saturday, Sunday, or Federal holiday and the application's U.S. filing
date is the next succeeding business day. Ex parte Olah, 131 USPQ 41
(Bd. App. 1960). Despite changes to  37 CFR 1.6(a)(2) and 1.10 which
require the PTO to accord a filing date to an application as of the date
of deposit as "Express Mail" with the U.S. Postal Service in accordance
with  37 CFR 1.10 (e.g., a Saturday filing date), the rule changes do
not affect applicant's concurrent right to defer the filing of an
application until the next business day when the last day for "taking
any action" falls on a Saturday, Sunday, or a Federal holiday (e.g., the
last day of the 1-year grace period falls on a Saturday).

THE 1-YEAR TIME BAR IS MEASURED FROM THE U.S. FILING DATE

If one discloses his or her own work more than 1  year before the filing
of the patent application, that person is barred from obtaining a
patent. In re Katz, 687 F.2d 450, 454, 215 USPQ 14, 17 (CCPA 1982). The
1-year time bar is measured from the U.S. filing date. Thus, applicant
will be barred from obtaining a patent if the public came into
possession of the invention on a date before the 1-year grace period
ending with the U.S. filing date. It does not matter how the public came
into possession of the invention. Public possession could occur by a
public use, public sale, a publication, a patent or any combination of
these. In addition, the prior art need not be identical to the claimed
invention but will bar patentability if it is an obvious variant
thereof. In re Foster, 343 F.2d 980, 145 USPQ 166 (CCPA 1966). See MPEP
Section  706.02 regarding the effective U.S. filing date of an
application.

---SECTION---2133.01 Rejections of Continuation-In-Part (CIP)
Applications

When applicant files a continuation-in-part whose claims are not
supported by the parent application, the effective filing date is the
filing date of the child CIP. Any prior art disclosing the invention or
an obvious variant thereof having a critical reference date more than 1
year prior to the filing date of the child will bar the issuance of a
patent under  35 U.S.C. 102(b).   Paperless Accounting v. Bay Area Rapid
Transit System, 804 F.2d 659, 665, 231 USPQ 649, 653 (Fed. Cir. 1986).

---SECTION---2133.02 Rejections Based on Publications and Patents

APPLICANT'S OWN WORK WHICH WAS AVAILABLE TO THE PUBLIC BEFORE THE GRACE
PERIOD MAY BE USED IN A 35 U.S.C. 102(b) REJECTION

"Any invention described in a printed publication more than one year
prior to the date of a patent application is prior art under Section
102(b), even if the printed publication was authored by the patent
applicant."   De Graffenried v. United States, 16 USPQ2d 1321, 1330 n.7
(Cl. Ct. 1990). "Once an inventor has decided to lift the veil of
secrecy from his [or her] work, he [or she] must choose between the
protection of a federal patent, or the dedication of his [or her] idea
to the public at large." Bonito Boats, Inc. v. Thunder Craft Boats,
Inc., 489 U.S. 141, 148, 9 USPQ2d 1847, 1851 (1989).

A 35 U.S.C. 102(b) REJECTION CREATES A STATUTORY BAR TO PATENTABILITY OF
THE REJECTED CLAIMS

A rejection under  35 U.S.C. 102(b) cannot be overcome by affidavits and
declarations under  37 CFR 1.131 (Rule 131 Declarations), foreign
priority dates, or evidence that applicant himself invented the subject
matter. Outside the 1-year grace period, applicant is barred from
obtaining a patent containing any anticipated or obvious claims. In re
Foster, 343 F.2d 980, 984, 145 USPQ 166, 170 (CCPA 1965).

---SECTION---2133.03 Rejections Based on "Public Use" or "On Sale"

35 U.S.C. 102(b) "contains several distinct bars to patentability, each
of which relates to activity or disclosure more than one year prior to
the date of the application. Two of these - the `public use' and the `on
sale' objections - are sometimes considered together although it is
quite clear that either may apply when the other does not." Dart Indus.
v. E.I. du Pont de Nemours & Co., 489 F.2d 1359, 1365, 179 USPQ 392, 396
(7th Cir. 1973). There may be a public use of an invention absent any
sales activity. Likewise, there may be a nonpublic, e.g., "secret," sale
or offer to sell an invention which nevertheless constitutes a statutory
bar. Hobbs v. United States, 451 F.2d 849, 859-60, 171 USPQ 713, 720
(5th Cir. 1971).

In similar fashion, not all "public use" and "on sale" activities will
necessarily occasion the identical result. Although both activities
affect how an inventor may use an invention prior to the filing of a
patent application, "non-commercial"  35 U.S.C. 102(b) activity may not
be viewed the same as similar "commercial" activity. See MPEP Section 
2133.03(a) and Section  2133.03(e)(1). Likewise, "public use" activity
by an applicant may not be considered in the same light as similar
"public use" activity by one other than an applicant. See MPEP Section 
2133.03(a) and Section  2133.03(e)(7).  Additionally, the concepts of
"completion" and "experimental use" have differing significance in
"commercial" and "non-commercial" environments. See MPEP Section 
2133.03(c) and Section  2133.03(e) -  Section  2133.03(e)(6).

It should be noted that  35 U.S.C. 102(b) may create a bar to
patentability either alone, if the device in public use or placed on
sale anticipates a later claimed invention, or in conjunction with  35
U.S.C. 103, if the claimed invention would have been obvious from the
device in conjunction with the prior art. LaBounty Mfg. v. United States
Int'l Trade Comm'n., 958 F.2d 1066, 1071, 22 USPQ2d 1025, 1028 (Fed.
Cir. 1992).

  POLICY CONSIDERATIONS

(A) "One policy underlying the [on-sale] bar is to obtain widespread
disclosure of new inventions to the public via patents as soon as
possible." RCA Corp. v. Data Gen. Corp., 887 F.2d 1056, 1062, 12 USPQ2d
1449, 1454 (Fed. Cir. 1989).

(B) The public use and on-sale bars are meant to prevent the inventor
from commercially exploiting the exclusivity of his [or her] invention
substantially beyond the statutorily authorized period. RCA Corp. v.
Data Gen. Corp., 887 F.2d 1056, 1062, 12 USPQ2d 1449, 1454 (Fed. Cir.
1989).  See MPEP Section  2133.03(e)(1).

(C) Another underlying policy for the public use and on-sale bars is to
discourage "the removal of inventions from the public domain which the
public justifiably comes to believe are freely available." Manville
Sales Corp. v. Paramount Sys., Inc., 917 F.2d 544, 549, 16 USPQ2d 1587,
1591 (Fed. Cir. 1990).

---SECTION---2133.03(a) "Public Use"

ONE USE IN THE PUBLIC DOMAIN BY ONE PERSON MAY BAR A PATENT

"[T]o constitute the public use of an invention it is not necessary that
more than one of the patent articles should be publicly used. The use of
a great number may tend to strengthen the proof, but one well defined
case of such use is just as effectual to annul the patent as many."
Likewise, it is not necessary that more than one person use the
invention. Egbert v. Lippmann, 104 U.S. 333, 336 (1881).

PUBLIC KNOWLEDGE IS NOT NECESSARILY PUBLIC USE UNDER 35 U.S.C. 102(b)

Mere knowledge of the invention by the public does not warrant rejection
under  35 U.S.C. 102(b).  35 U.S.C. 102(b) bars public use or sale, not
public knowledge. TP Labs., Inc., v. Professional Positioners, Inc., 724
F.2d 965, 970, 220 USPQ 577, 581 (Fed. Cir. 1984).

Note, however, that public knowledge may provide grounds for rejection
under  35 U.S.C. 102(a). See MPEP Section  2132.

A. Commercial Versus Noncommercial Use and the Impact of Secrecy

1. "Public Use" and "Non-secret Use" Are Not Necessarily Synonymous

"Public" is not necessarily synonymous with "non- secret." The fact
"that non-secret uses of the device were made [by the inventor or
someone connected with the inventor] prior to the critical date is not
itself dispositive of the issue of whether activity barring a patent
under  35 U.S.C. 102(b) occurred. The fact that the device was not
hidden from view may make the use not secret, but nonsecret use is not  
ipso facto `public use' activity. Nor, it must be added, is all secret
use   ipso facto not `public use' within the meaning of the statute," if
the inventor is making commercial use of the invention under
circumstances which preserve its secrecy. TP Labs., Inc. v. Professional
Positioners, Inc., 724 F.2d 965, 972, 220 USPQ 577, 583 (Fed. Cir. 1983)
(citations omitted).

2. Even If the Invention Is Hidden, Inventor Who Puts Machine or Article
Embodying the Invention in Public View Is Barred from Obtaining a Patent
as the Invention Is in Public Use

When the inventor or someone connected to the inventor puts the
invention on display or sells it, there is a "public use" within the
meaning of  35 U.S.C. 102(b) even though by its very nature an invention
is completely hidden from view as part of a larger machine or article,
if the invention is otherwise used in its natural and intended way and
the larger machine or article is accessible to the public.   In re
Blaisdell, 242 F.2d 779, 783, 113 USPQ 289, 292 (CCPA 1957); Hall v.
Macneale, 107 U.S. 90, 96-97 (1882);   Ex parte Kuklo, 25 USPQ2d 1387,
1390 (Bd. Pat. App. & Inter. 1992) (Display of equipment including the
structural features of the claimed invention to visitors of laboratory
is public use even though public did not see inner workings of device.
The person to whom the invention is publicly disclosed need not
understand the significance and technical complexities of the
invention.).

3. There Is No Public Use If Inventor Restricted Use to Locations Where
There Was a Reasonable Expectation of Privacy and the Use Was for His or
Her Own Enjoyment

An inventor's private use of the invention, for his or her own enjoyment
is not a public use. Moleculon Research Corp. v. CBS, Inc., 793 F.2d
1261, 1265, 229 USPQ 805, 809 (Fed. Cir. 1986) (Inventor showed
inventive puzzle to close friends while in his dorm room and later the
president of the company at which he was working saw the puzzle on the
inventor's desk and they discussed it. Court held that the inventor
retained control and thus these actions did not result in a "public
use.").

B. Use by Third Parties Deriving the Invention from Applicant

An Invention Is in Public Use If the Inventor Allows Another To Use the
Invention Without Restriction or Obligation of Secrecy

"Public use" of a claimed invention under  35 U.S.C. 102(b) occurs when
the inventor allows another person to use the invention without
limitation, restriction or obligation of secrecy to the inventor."   In
re Smith, 714 F.2d 1127, 1134, 218 USPQ 976, 983 (Fed. Cir. 1983). The
presence or absence of a confidentiality agreement is not itself
determinative of the public use issue, but is one factor to be
considered along with the time, place, and circumstances of the use
which show the amount of control the inventor retained over the
invention. Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 1265,
229 USPQ 805, 809 (Fed. Cir. 1986). See Ex parte C, 27 USPQ2d 1492, 1499
(Bd. Pat. App. & Inter. 1992) (Inventor sold inventive soybean seeds to
growers who contracted and were paid to plant the seeds to increase
stock for later sale. The commercial nature of the use of the seed
coupled with the "on-sale" aspects of the contract and apparent lack of
confidentiality requirements rose to the level of a "public use" bar.);
Egbert v. Lippmann, 104 U.S. 333, 336 (1881) (Public use found where
inventor allowed another to use inventive corset insert, though hidden
from view during use, because he did not impose an obligation of secrecy
or restrictions on its use.).

C. Use by Independent Third Parties

Use by an Independent Third Party Is Public Use If It Sufficiently
"Informs" the Public of the Invention or a Competitor Could Reasonably
Ascertain the Invention

Any "nonsecret" use of an invention by someone unconnected to the
inventor, such as someone who has independently made the invention, in
the ordinary course of a business for trade or profit may be a "public
use," Bird Provision Co. v. Owens Country Sausage, Inc., 568 F.2d 369,
374-76, 197 USPQ 134, 138-40 (5th Cir. 1978). Additionally, even a
"secret" use by another inventor of a machine or process to make a
product is "public" if the details of the machine or process are
ascertainable by inspection or analysis of the product that is sold or
publicly displayed. Gillman v. Stern, 114 F.2d 28, 46 USPQ 430 (2d Cir.
1940); Dunlop Holdings, Ltd. v. Ram Golf Corp., 524 F.2d 33, 36-7, 188
USPQ 481, 483-484 (7th Cir. 1975).  If the details of an inventive
process are not ascertainable from the product sold or displayed and the
third party has kept the invention as a trade secret then that use is
not a public use and will not bar a patent issuing to someone
unconnected to the user. W.L. Gore & Assocs. v. Garlock, Inc., 721 F.2d
1540, 1550, 220 USPQ 303, 310 (Fed. Cir. 1983). However, a device
qualifies as prior art if it places the claimed features in the public's
possession before the critical date even if other unclaimed aspects of
the device were not publicly available. Lockwood v. American Airlines,
Inc., 41 USPQ2d 1961, 1964-65 (Fed. Cir. 1997) (Computer reservation
system was prior art even though "essential algorithms of the SABRE
software were proprietary and confidential and...those aspects of the
system that were readily apparent to the public would not have been
sufficient to enable one skilled in the art to duplicate the [unclaimed
aspects of the] system." ). The extent that the public becomes
"informed" of an invention involved in public use activity by one other
than an applicant depends upon the factual circumstances surrounding the
activity and how these comport with the policies underlying the on sale
and public use bars. Manville Sales Corp. v. Paramount Sys., Inc., 917
F.2d 544, 549, 16 USPQ2d 1587, 1591 (Fed. Cir. 1990) (quoting King
Instrument Corp. v. Otari Corp., 767 F.2d 833, 860, 226 USPQ 402, 406
(Fed Cir. 1985)). By way of example, in an allegedly "secret" use by a
third party other than an applicant, if a large number of employees of
such a party, who are not under a promise of secrecy, are permitted
unimpeded access to an invention, with affirmative steps by the party to
educate other employees as to the nature of the invention, the public is
"informed." Chemithon Corp. v. Proctor & Gamble Co., 287 F. Supp. 291,
308, 159 USPQ 139, 154 (D.Md. 1968), aff'd., 427 F.2d 893, 165 USPQ 678
(4th Cir. 1970).

Even if public use activity by one other than an applicant is not
sufficiently "informing," there may be adequate grounds upon which to
base a rejection under  35 U.S.C. 102(f) and  35 U.S.C. 102(g). See  
Dunlop Holdings Ltd. v. Ram Golf Corp., 524 F.2d 33, 188 USPQ 481 (7th
Cir. 1975). See MPEP Section  2137 and Section  2138.

---SECTION---2133.03(b) "On Sale"

An impermissible sale has occurred if there was a definite sale, or
offer to sell, more than 1 year before the effective filing date of the
U.S. application and the subject matter of the sale, or offer to sell,
fully anticipated the claimed invention or would have rendered the
claimed invention obvious by its addition to the prior art. Ferag AG v.
Quipp, Inc., 45 F.3d 1562, 1565, 33 USPQ2d 1512, 1514 (Fed. Cir. 1995).

I. THE MEANING OF "SALE"

A sale is a contract between parties wherein the seller agrees "to give
and to pass rights of property" in return for the buyer's payment or
promise "to pay the seller for the things bought or sold." In re
Caveney, 761 F.2d 671, 676, 226 USPQ 1, 4 (Fed. Cir. 1985).

A. Conditional Sale May Bar a Patent

An invention may be deemed to be "on sale" even though the sale was
conditional. The fact that the sale is conditioned on buyer satisfaction
does not, without more, prove that the sale was for an experimental
purpose. Strong v. General Elec. Co., 434 F.2d 1042, 1046, 168 USPQ 8,
12 (5th Cir. 1970).

B. Nonprofit Sale May Bar a Patent

A "sale" need not be for profit to bar a patent. If the sale was for the
commercial exploitation of the invention, it is "on sale" within the
meaning of  35 U.S.C. 102(b). In re Dybel, 524 F.2d 1393, 1401, 187 USPQ
593, 599 (CCPA 1975) ("Although selling the devices for a profit would
have demonstrated the purpose of commercial exploitation, the fact that
appellant realized no profit from the sales does not demonstrate the
contrary.").

C. A Single Sale or Offer To Sell May Bar a Patent

Even a single sale or offer to sell the invention may bar patentability
under  35 U.S.C. 102(b). Consolidated Fruit-Jar Co. v. Wright, 94 U.S.
92, 94 (1876); Atlantic Thermoplastics Co. v. Faytex Corp., 970 F.2d
834, 836-37, 23 USPQ2d 1481, 1483 (Fed. Cir. 1992).

D. A Sale of Rights Is Not a Sale of the Invention and Will Not in
Itself Bar a Patent

"An assignment or sale of the rights, such as patent rights, in the
invention is not a sale of `the invention' within the meaning of section
102(b)." The sale must involve the delivery of the physical invention
itself. Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 1265, 229
USPQ 805, 809 (Fed. Cir. 1986).

E. Buyer Must Be Uncontrolled by the Seller or Offerer

A sale or offer for sale must take place between separate entities. In
re Caveney, 761 F.2d 671, 676, 226 USPQ 1, 4 (Fed. Cir. 1985). "Where
the parties to the alleged sale are related, whether there is a
statutory bar depends on whether the seller so controls the purchaser
that the invention remains out of the public's hands. Ferag AG v. Quipp,
Inc., 45 F.3d 1562, 1566, 33 USPQ2d 1512, 1515 (Fed. Cir. 1995) (Where
the seller is a parent company of the buyer company, but the President
of the buyer company had "essentially unfettered" management authority
over the operations of the buyer company, the sale was a statutory
bar.).

II. OFFERS FOR SALE

A. Rejected or Unreceived Offer for Sale Is Enough To Bar a Patent

Since the statute creates a bar when an invention is placed "on sale," a
mere offer to sell is sufficient commercial activity to bar a patent. In
re Theis, 610 F.2d 786, 791, 204 USPQ 188, 192 (CCPA 1979). Even a
rejected offer may create an on sale bar. UMC Elecs. v. United States,
816 F.2d 647, 653, 2 USPQ2d 1465, 1469 (Fed. Cir. 1987). In fact, the
offer need not even be actually received by a prospective purchaser.
Wende v. Horine, 225 F. 501 (7th Cir. 1915).

B. Delivery of the Offered Item Is Not Required

"It is not necessary that a sale be consummated for the bar to operate."
Buildex v. Kason Indus.,   Inc., 849 F.2d 1461, 1463-64, 7 USPQ2d 1325,
1327-28 (Fed. Cir. 1988) (citations omitted).

C. Seller Need Not Have the Goods "On Hand" when the Offer for Sale Is
Made

Goods need not be "on hand" and transferred at the time of the sale or
offer. The date of the offer for sale is the effective date of the "on
sale" activity. J. A. La Porte, Inc. v. Norfolk Dredging Co., 787 F.2d
1577, 1582, 229 USPQ 435, 438 (Fed. Cir. 1986). However, the invention
must be more than a mere conception and at least close to completeness
(see MPEP Section  2133.03(c)) before the critical date. UMC Elecs. v.
United States, 816 F.2d 647, 2 USPQ2d 1465 (Fed. Cir. 1987). See also  
Micro Chemical, Inc. v. Great Plains Chemical Co., 103 F.3d 1538, 1545,
41 USPQ2d 1238, 1243 (Fed. Cir. 1997) (The on-sale bar was not triggered
by an offer to sell because the inventor "was not close to completion of
the invention at the time of the alleged offer and had not demonstrated
a high likelihood that the invention would work for its intended purpose
upon completion."); Shatterproof Glass Corp. v. Libbey-Owens Ford Co.,
758 F.2d 613, 225 USPQ 634 (Fed. Cir. 1985) (Where there was no evidence
that the samples shown to the potential customers were made by the new
process and apparatus, the offer to sell did not rise to the level of an
on sale bar.). Compare Barmag Barmer Maschinenfabrik AG v. Murata Mach.,
Ltd., 731 F.2d 831, 221 USPQ 561 (Fed. Cir. 1984) (Where a "make shift"
model of the inventive product was shown to the potential purchasers in
conjunction with the offer to sell, the offer was enough to bar a patent
under  35 U.S.C. 102(b).).

III. SALE BY INVENTOR, ASSIGNEE OR OTHERS ASSOCIATED WITH THE INVENTOR
IN THE COURSE OF BUSINESS

A. Sale Activity Need Not Be Public

Unlike questions of public use, there is no requirement that "on sale"
activity be "public." "Public" as used in  35 U.S.C. 102(b) modifies
"use" only. "Public" does not modify "sale." Hobbs v. United States, 451
F.2d 849, 171 USPQ 713, 720 (5th Cir. 1971).

B. Inventor's Consent to the Sale Is Not a Prerequisite To Finding an On
Sale Bar

If the invention was placed on sale by a third party who obtained the
invention from the inventor, a patent is barred even if the inventor did
not consent to the sale or have knowledge that the invention was
embodied in the sold article. Electric Storage Battery Co. v. Shimadzu,
307 U.S. 5, 41 USPQ 155 (1938); In re Blaisdell, 242 F.2d 779, 783, 113
USPQ 289, 292 (CCPA 1957); CTS Corp. v. Electro Materials Corp. of
America, 469 F. Supp. 801, 819, 202 USPQ 22, 38 (S.D.N.Y. 1979).

C. Objective Evidence of Intent To Sell Is Needed

In determining if a sale or offer to sell has occurred a key question to
ask is whether, under the totality of the circumstances, the inventor
placed his or her invention on sale, objectively manifested by a sale or
offer for sale of a product that embodies the invention claimed in the
application. Objective evidence such as a description of the inventive
product in the contract of sale or in another communication with the
purchaser controls over an uncommunicated intent by the seller to
deliver the inventive product under the contract for sale. Ferag AG v.
Quipp, Inc., 45 F.3d 1562, 1567, 33 USPQ2d 1512, 1516 (Fed. Cir. 1995)
(On sale bar found where initial negotiations and agreement containing
contract for sale neither clearly specified nor precluded use of the
inventive design but an order confirmation more than 1 year prior to
filing of patent application for the inventive design did specify use of
inventive design.). The purchaser need not have actual knowledge of the
invention for it to be on sale. "For example, merely offering to sell a
product by way of an advertisement or invoice may be evidence of a
definite offer for sale or a sale of a claimed invention even though no
details are disclosed. That the offered product is in fact the claimed
invention may be established by any relevant evidence, such as
memoranda, drawings, correspondence, and testimony of witnesses." RCA
Corp. v. Data Gen. Corp., 887 F.2d 1056, 1060, 12 USPQ2d 1449, 1452
(Fed. Cir. 1989). However, "what the purchaser reasonably believes the
inventor to be offering is relevant to whether, on balance, the offer
objectively may be said to be of the patented invention." Envirotech
Corp. v. Westech Eng'g, Inc., 904 F.2d 1571, 1576, 15 USPQ2d 1230, 1234
(Fed. Cir. 1990) (Where a proposal to supply a general contractor with a
product did not mention a new design but, rather, referenced a prior art
design, the uncommunicated intent of the supplier to supply the new
design if awarded the contract did not constitute an "on sale" bar to a
patent on the new design, even though the supplier's bid reflected the
lower cost of the new design.).

IV. SALES BY INDEPENDENT THIRD PARTIES

A. Sales or Offers for Sale by Independent Third Parties Will Bar a
Patent

Sale or offer for sale of the invention by an independent third party
more than 1 year before the filing date of applicant's patent will bar
applicant from obtaining a patent. "An exception to this rule exists
where a patented method is kept secret and remains secret after a sale
of the unpatented product of the method. Such a sale prior to the
critical date is a bar if engaged in by the patentee or patent
applicant, but not if engaged in by another."   In re Caveney, 761 F.2d
671, 675-76, 226 USPQ 1, 3-4 (Fed. Cir. 1985).

B. Nonprior Art Publications Can Be Used as Evidence of Sale Before the
Critical Date

Abstracts identifying a product's vendor containing information useful
to potential buyers such as whom to contact, price terms, documentation,
warranties, training and maintenance along with the date of product
release or installation before the inventor's critical date may provide
sufficient evidence of prior sale by a third party to support a
rejection based on  35 U.S.C. 102(b) or 103. In re Epstein, 32 F.3d
1559, 31 USPQ2d 1817 (Fed. Cir. 1994) (Examiner's rejection was based on
nonprior art published abstracts which disclosed software products
meeting the claims. The abstracts specified software release dates and
dates of first installation which were more than 1 year before
applicant's filing date.).

---SECTION---2133.03(c) The "Invention"

35 U.S.C. 102 Conditions for patentability; novelty and loss of right to
patent.

A person shall be entitled to a patent unless -

                  +++    

(b) the invention was -- in public use or on sale in this country, more
than one year prior to the date of the application for patent in the
United States

                  +++    

(Emphasis added).

I. LEVEL OF COMPLETENESS REQUIRED

The level of completion required likely will differ in cases of "public
use" which are not intertwined with a sale. UMC Elecs. Co. v. United
States, 816 F.2d 647, 652 n.6, 2 USPQ2d 1465, 1468 n.6 (Fed. Cir. 1987).
The court decisions do not address the level required in pure "public
use" cases but it is unlikely that the invention can be publicly used
without a working embodiment. The case law presented below is directed
to "on sale" situations.

A. The Invention Need Not Be "Complete" or "Reduced To Practice" at the
Time of the Sale

If the invention was actually reduced to practice before being sold or
offered for sale more than 1 year before filing of the application, a
patent will be barred. In re Hamilton, 882 F.2d 1576, 1580, 11 USPQ2d
1890, 1893 (Fed. Cir. 1989). Actual reduction to practice in this
context usually requires testing under actual working conditions in such
a way as to demonstrate the practical utility of an invention for its
intended purpose beyond the probability of failure, unless by virtue of
the very simplicity of an invention its practical operativeness is
clear. Field v. Knowles, 183 F.2d 593, 601, 86 USPQ 373, 379 (CCPA
1950); Steinberg v. Seitz, 517 F.2d 1359, 1363, 186 USPQ 209, 212 (CCPA
1975).

A reduction to practice of the claimed invention is not an absolute
requirement of the on sale bar. KeyStone Retaining Wall Sys., Inc. v.
Westrock, Inc., 997 F.2d 144, 1451, 27 USPQ2d 1297, 1303 (Fed. Cir.
1993). Sometimes "something less than a complete embodiment of the
invention will suffice." However, the offering for sale of a mere
conception of the invention before the critical date is not enough. One
must look at the totality of the circumstances and what they show as to
whether the inventor was attempting to commercialize the invention and
thereby impermissibly extend the patent term or other wise contravene
any other of the policies furthered by the "on sale" bar. UMC Elecs. Co.
v. United States, 816 F.2d 647, 656, 2 USPQ2d 1465, 1471-72 (Fed. Cir.
1987). In UMC Elecs. Co., the court held that the invention, while
uncompleted before the critical date, was on sale within the meaning of 
35 U.S.C. 102(b) and enunciated several factors leading to its decision.
The development of the subject invention was far beyond a mere
conception. Much of the invention was embodied in tangible form. The
prior art devices embodied each element of the claimed invention, save
one, and that portion was and had been sufficiently tested to
demonstrate to the satisfaction of the inventor that the invention as
ultimately claimed would work for its intended purpose.

B. Depends on How Certain the Inventor Is of the Nature and Usefulness
of the Device

Even if the inventor has not translated his or her invention into a
working device, the invention may be sufficiently complete to create an
"on sale" bar. Philco Corp. v. Admiral Corp., 199 F. Supp. 797 817, 131
USPQ 413, 430 (D. Del. 1961). "What is required is that the inventor
have some certainty as to the nature and usefulness of the finished
product." In other words, "the invention must have been `sufficiently
tested to demonstrate that it will work for its intended purpose.' "
Shatterproof Glass Corp. v. Libbey-Owens Ford Co., 758 F.2d 613, 622,
225 USPQ 634, 640 (Fed. Cir. 1985). See also   Micro Chemical, Inc. v.
Great Plains Chemical Co., 103 F.3d 1538, 1545, 41 USPQ2d 1238, 1243
(Fed. Cir. 1997) (The on-sale bar was not triggered by an offer to sell
because the inventor "was not close to completion of the invention at
the time of the alleged offer and had not demonstrated a high likelihood
that the invention would work for its intended purpose upon
completion.").

Circumstances Showing Certainty

If, at the time the device is offered for sale, the inventor is close to
production of the device embodied in the claims and both the seller and
offerer know what is to be sold, the invention is sufficiently complete
to give rise to an on-sale bar. Philco Corp. v. Admiral Corp., 199 F.
Supp. 797, 817, 131 USPQ 413, 430 (D. Del. 1961).

Where the evidence establishes that an inventor's confidence in an
invention is shared by a party to whom the inventor has shown specific
drawings, which in turn precipitated initial commercial activity
relative to the invention by the other party, the invention is
sufficiently "complete" to invoke an "on sale" bar. Langsett v. Marmet
Corp., 231 F. Supp. 759, 766, 141 USPQ 903, 910-11 (W.D. Wis. 1964).
However, where parties enter into a contract to construct a device to
meet certain performance factors, a sufficient level of "completeness"
may not be present until there is reasonable agreement that the
performance factors have in fact been met.

Even if an invention has been reduced "to a reality," the invention is
not necessarily "complete" enough to create an "on sale" bar unless one
would know how the invention would work upon installation. In re Dybel,
524 F.2d 1393, 1400, 187 USPQ 593, 598 (CCPA 1975). However, such
knowledge is not synonymous with a lack of any expectation of "problems"
upon installation. As long as the "problems" are not due to "fundamental
defects" in the invention, there will be sufficient "completion." In re
Theis, 610 F.2d 786, 794 n.11, 204 USPQ 188, 195 n. 11 (CCPA 1979);
National Biscuit Co. v. Crown Baking Co., 105 F.2d 422, 424, 42 USPQ
214, 215 (1st Cir. 1939).

The invention need not be ready for satisfactory commercial marketing
for sale to bar a patent. Atlantic Thermoplastics Co. v. Faytex Corp.,
970 F.2d 834, 836-37, 23 USPQ2d 1481, 1483 (Fed. Cir. 1992).

II. INVENTOR HAS SUBMITTED A 37 CFR 1.131 AFFIDAVIT OR DECLARATION

Affidavits or declarations submitted under  37 CFR 1.131 to swear behind
a reference may constitute, among other things, an admission that an
invention was "complete" more than 1 year before the filing of an
application. See   In re Foster, 342 F.2d 980, 987-88, 145 USPQ 166, 173
(CCPA 1965); Dart Indus. v. E.I. duPont de Nemours & Co., 489 F.2d 1359,
1365, 179 USPQ 392, 396 (7th Cir. 1973). Also see MPEP Section  715.10.

---SECTION---2133.03(d) "In This Country"

For purposes of judging the applicability of the  35 U.S.C. 102(b) bars,
public use or on sale activity must take place in the United States. The
"on sale" bar does not generally apply where both manufacture and
delivery occur in a foreign country. Gandy v. Main Belting Co., 143 U.S.
587, 593 (1892). However, "on sale" status can be found if substantial
activity prefatory to a "sale" occurs in the United States. Robbins Co.
v. Lawrence Mfg. Co., 482 F.2d 426, 433, 178 USPQ 577, 583 (9th Cir.
1973). An offer for sale, made or originating in this country, may be
sufficient prefatory activity to bring the offer within the terms of the
statute, even though sale and delivery take place in a foreign country.
The same rationale applies to an offer by a foreign manufacturer which
is communicated to a prospective purchaser in the United States prior to
the critical date. CTS Corp. v. Piher Int'l Corp., 593 F.2d 777, 201
USPQ 649 (7th Cir. 1979).

---SECTION---2133.03(e) Permitted Activity; Experimental Use

The basic test is that experimentation must be the primary purpose and
any commercial exploitation must be incidental.

If the use or sale was experimental, there is no bar under  35 U.S.C.
102(b). "A use or sale is experimental for purposes of section 102(b) if
it represents a bona fide effort to perfect the invention or to
ascertain whether it will answer its intended purpose. -- If any
commercial exploitation does occur, it must be merely incidental to the
primary purpose of the experimentation to perfect the invention."
LaBounty Mfg. v. United States Int'l Trade Comm'n, 958 F.2d 1066, 1071,
22 USPQ2d 1025, 1028 (Fed. Cir. 1992) (quoting Pennwalt Corp. v. Akzona
Inc., 740 F.2d 1573, 1581, 222 USPQ 833, 838 (Fed. Cir. 1984)). "The
experimental use exception -- does not include market testing where the
inventor is attempting to gauge consumer demand for his claimed
invention. The purpose of such activities is commercial exploitation and
not experimentation." In re Smith, 714 F.2d 1127, 1134, 218 USPQ 976,
983 (Fed. Cir. 1983).

---SECTION---2133.03(e)(1) Commercial Exploitation

THERE MUST BE NO ATTEMPT AT MARKET PENETRATION BEFORE THE CRITICAL DATE

A strong policy of the on sale and public use bars is the prevention of
inventors from exploiting their inventions commercially more than 1 year
prior to the filing of a patent application. Therefore, if applicant's
precritical date activity is, at any level, an attempt at market
penetration, a patent is barred. Thus, even if there is bona fide
experimental activity, an inventor may not commercially exploit an
invention more than 1 year prior to the filing date of an application.
In re Theis, 610 F.2d 786, 793, 204 USPQ 188, 194 (CCPA 1979).

THE COMMERCIAL ACTIVITY MUST LEGITIMATELY ADVANCE DEVELOPMENT OF THE
INVENTION TOWARDS COMPLETION

As the degree of commercial exploitation surrounding  35 U.S.C. 102(b)
activity increases, the burden on an applicant to establish clear and
convincing evidence of experimental activity with respect to a public
use becomes more difficult. Where the examiner has found a prima facie
case of a sale or an offer to sell, this burden will rarely be met
unless clear and convincing necessity for the experimentation is
established by the applicant. This does not mean, of course, that there
are no circumstances which would permit alleged experimental activity in
an atmosphere of commercial exploitation. In certain circumstances, even
a sale may be necessary to legitimately advance the experimental
development of an invention if the primary purpose of the sale is
experimental. In re Theis, 610 F.2d 786, 793, 204 USPQ 188, 194 (CCPA
1979); Robbins Co. v. Lawrence Mfg. Co., 482 F.2d 426, 433, 178 USPQ
577, 582 (9th Cir. 1973). However, careful scrutiny by the examiner of
the objective factual circumstances surrounding such a sale is
essential. See Ushakoff v. United States, 327 F.2d 669, 140 USPQ 341
(Ct.Cl. 1964); Cloud v. Standard Packaging Corp., 376 F.2d 384,  153
USPQ 317 (7th Cir. 1967).

SIGNIFICANT FACTORS INDICATIVE OF "COMMERCIAL EXPLOITATION"

As discussed in MPEP Section  2133.03, a policy consideration in
questions of  35 U.S.C. 102(b) activity is premature "commercial
exploitation" of a "completed" or nearly completed invention (see MPEP
Section  2133.03(c)). The extent of commercial activity which
constitutes  35 U.S.C. 102(b) "on sale" status depends upon the
circumstances of the activity, the basic indicator being the subjective
intent of the inventor as manifested through objective evidence. The
following activities should be used by the examiner as indicia of this
subjective intent:

(A) Preparation of various contemporaneous "commercial" documents, e.g.,
orders, invoices, receipts, delivery schedules, etc.;

(B) Preparation of price lists (Akron Brass Co. v. Elkhart Brass Mfg.
Co., 353 F.2d 704, 709, 147 USPQ 301, 305 (7th Cir. 1965) and
distribution of price quotations (Amphenol Corp. v. General. Time Corp.,
158 USPQ 113, 117 (7th Cir. 1968));

(C) Display of samples to prospective customers (Cataphote Corp. v.
DeSoto Chemical Coatings, Inc., 356 F.2d 24, 27, 148 USPQ 527, 529 (9th
Cir. 1966) mod. on other grounds, 358 F.2d 732, 149 USPQ 159 (9th Cir.),
cert. denied, 385 U.S. 832 (1966); Chicopee Mfg. Corp. v. Columbus Fiber
Mills Co., 165 F.Supp. 307, 323-325, 118 USPQ 53, 65-67 (M.D.Ga. 1958));

(D) Demonstration of models or prototypes (General Elec. Co. v. United
States, 206 USPQ 260, 266-67 (Ct. Cl. 1979); Red Cross Mfg. v. Toro
Sales Co., 525 F.2d 1135, 1140, 188 USPQ 241, 244-45 (7th Cir. 1975);
Philco Corp. v. Admiral Corp., 199 F. Supp. 797, 815-16, 131 USPQ 413,
429-30 (D.Del. 1961)), especially at trade conventions (InterRoyal Corp.
v. Simmons Co., 204 USPQ 562, 563-65 (S.D. N.Y. 1979)), and even though
no orders are actually obtained (Monogram Mfg. v. F. & H. Mfg.,144 F.2d
412, 62 USPQ 409, 412 (9th Cir. 1944));

(E) Use of an invention where an admission fee is charged (In re
Josserand, 188 F.2d 486, 491, 89 USPQ 371, 376 (CCPA 1951); Greenewalt
v. Stanley, 54 F.2d 195, 12 USPQ 122 (3d Cir. 1931)); and

(F) Advertising in publicity releases, brochures, and various
periodicals (In re Theis, 610 F.2d 786, 792 n.6, 204 USPQ 188, 193 n. 6
(CCPA 1979); InterRoyal Corp. v. Simmons Co., 204 USPQ 562, 564-66
(S.D.N.Y.1979); Akron Brass, Inc.  v. Elkhart Brass Mfg., Inc., 353 F.2d
704, 709, 147 USPQ 301, 305 (7th Cir.1965); Tucker Aluminum Prods. v.
Grossman, 312 F.2d 393, 394, 136 USPQ 244, 245 (9th Cir. 1963)).

The above activities may be determinative of "commercial exploitation"
even though:

(A) Prices are estimated rather than established,

(B) No commercial production runs have been made, and

(C) The invention is never actually sold. Chromalloy Am. Corp. v. Alloy
Surfaces Co., 339 F. Supp. 859, 869, 173 USPQ 295, 301-02 (D.Del. 1972).

---SECTION---2133.03(e)(2) Intent

"When sales are made in an ordinary commercial environment and the goods
are placed outside the inventor's control, an inventor's secretly held
subjective intent to `experiment,' even if true, is unavailing without
objective evidence to support the contention. Under such circumstances,
the customer at a minimum must be made aware of the experimentation."
LaBounty Mfg., Inc. v. United States Int'l Trade Comm'n, 958 F.2d 1066,
1072, 22 USPQ2d 1025, 1029 (Fed. Cir. 1992) (quoting   Harrington Mfg.
Co. v. Powell Mfg. Co., 815 F.2d 1478, 1480 n.3, 2 USPQ2d 1364, 1366 n.3
(Fed. Cir. 1986); Paragon Podiatry Laboratory, Inc. v. KLM Labs., Inc.,
984 F.2d 1182, 25 USPQ2d 1561 (Fed. Cir. 1993) (Paragon sold the
inventive units to the trade as completed devices without any disclosure
to either doctors or patients of their involvement in alleged testing.
Evidence of the inventor's secretly held belief that the units were not
durable and may not be satisfactory for consumers was not sufficient,
alone, to avoid a statutory bar.).

---SECTION---2133.03(e)(3) "Completeness" of the Invention

EXPERIMENTAL USE ENDS WHEN THE INVENTION IS ACTUALLY REDUCED TO PRACTICE

Experimental use "means perfecting or completing an invention to the
point of determining that it will work for its intended purpose."
Therefore, experimental use "ends with an actual reduction to practice."
RCA Corp. v. Data Gen. Corp., 887 F.2d 1056, 1061, 12 USPQ2d 1449, 1453
(Fed. Cir. 1989). If the examiner concludes from the evidence of record
that an applicant was satisfied that an invention was in fact
"complete," awaiting approval by the applicant from an organization such
as Underwriters' Laboratories will not normally overcome this
conclusion.   InterRoyal Corp. v. Simmons Co., 204 USPQ 562, 566
(S.D.N.Y. 1979); Skil Corp. v. Rockwell Manufacturing Co., 358 F. Supp.
1257, 1261, 178 USPQ 562, 565 (N.D.Ill. 1973),   aff'd. in part, rev'd
in part sub nom. Skil Corp. v. Lucerne Products Inc., 503 F.2d 745, 183
USPQ 396, 399 (7th Cir. 1974), cert. denied, 420 U.S. 974, 185 USPQ 65
(1975). See MPEP Section  2133.03(c) for more information of what
constitutes a "complete" invention.

The fact that alleged experimental activity does not lead to specific
modifications or refinements of an invention is evidence, although not
conclusive evidence, that such activity is not within the realm
permitted by the statute. This is especially the case where the evidence
of record clearly demonstrates to the examiner that an invention was
considered "complete" by an inventor at the time of the activity.
Nevertheless, any modifications or refinements which did result from
such experimental activity must at least be a feature of the claimed
invention to be of any probative value. In re Theis, 610 F.2d 786, 793,
204 USPQ 188, 194 (CCPA 1979).

DISPOSAL OF PROTOTYPES

Where a prototype of an invention has been disposed of by an inventor
before the critical date, inquiry by the examiner should focus upon the
intent of the inventor and the reasonableness of the disposal under all
circumstances. The fact that an otherwise reasonable disposal of a
prototype involves incidental income is not necessarily fatal. In re
Dybel, 524 F.2d 1393, 1399, n.5, 187 USPQ 593, 597 n.5 (CCPA 1975).
However, if a prototype is considered "complete" by an inventor and all
experimentation on the underlying invention has ceased, unrestricted
disposal of the prototype constitutes a bar under  35 U.S.C. 102(b). In
re Blaisdell, 242 F.2d 779, 113 USPQ 289 (CCPA 1957);   contra, Watson
v. Allen, 254 F.2d 342, 117 USPQ 68 (D.C. Cir. 1958).

---SECTION---2133.03(e)(4) Factors Indicative of an Experimental Purpose

The Court in   City of Elizabeth v. American Nicholson Pavement Co., 97
U.S. 126 (1878) found several factors persuasive of experimental
activity:

(A) the nature of the invention was such that any testing had to be to
some extent public;

(B) testing had to be for a substantial period of time;

(C) testing was conducted under the supervision and control of the
inventor; and

(D) the inventor regularly inspected the invention during the period of
experimentation.

Supreme Court decisions subsequent to City of Elizabeth identify other
significant factors which may be determinative of experimental purpose:

(E) extent of any obligations or limitation placed on a user during a
period of experimental activity, as well as the extent of an testing
actually performed during such period (Egbert v. Lippmann, 104 U.S. 333
(1881));

(F) conditional nature of any sale associated with experimental activity
(Hall v. Macneale, 107 U.S. 90 (1882)); and

(G) length of time and number of cases in which experimental activity
took place, viewed in light of what was reasonably necessary for an
alleged experimental purpose (International Tooth Crown Co. v. Gaylord,
140 U.S. 55 (1891)).

Other judicial opinions have supplemented these factors by looking to
the extent of any:

(H) explicit or implicit obligations placed upon a user to supply an
inventor with the results of any testing conducted during an
experimental period and the extent of inquiry made by the inventor
regarding the testing (Robbins Co. v. Lawrence Mfg. Co., 178 USPQ 577,
583 (9th Cir. 1973));

(I) disclosure by an inventor to a user regarding what the inventor
considers as unsatisfactory operation of the invention (In re Dybel, 524
F.2d 1393, 1401, 187 USPQ 593, 599 (CCPA 1975));

(J) effort on the part of an inventor to retrieve any experimental
samples at the end of an experimental period (Omark Indus. v. Carlton
Co., 458 F.Supp. 449, 454, 201 USPQ 825, 830 (D.Ore. 1978)); and

(K) a doctor-patient relationship where the inventor/doctor conducted
the experimentation (TP Labs. Inc. v. Professional Positioners, Inc.,
724 F.2d 965, 971, 220 USPQ 577, 582 (Fed. Cir. 1984).

Summarizing the above, once alleged experimental activity is advanced by
an applicant to explain a prima facie case under  35 U.S.C. 102(b), the
examiner must determine whether the scope and length of the activity
were reasonable in terms of the experimental purpose intended by the
applicant and the nature of the subject matter involved. No one of, or
particular combination of, factors (A) through (K) is necessarily
determinative of this purpose.

---SECTION---2133.03(e)(5) Experimentation and Degree of Supervision and
Control

THE INVENTOR MUST MAINTAIN SUFFICIENT CONTROL OVER THE INVENTION DURING
TESTING BY THIRD PARTIES

As discussed with reference to City of Elizabeth v. American Nicholson
Pavement Co., 97 U.S. 126 (1878), a significant determinative factor in
questions of experimental purpose is the extent of supervision and
control maintained by an inventor over an invention during an alleged
period of experimentation. Once a period of experimental activity has
ended and supervision and control has been relinquished by an inventor
without any restraints on subsequent use of an invention, an
unrestricted subsequent use of the invention is a  35 U.S.C. 102(b) bar.
In re Blaisdell, 242 F.2d 779, 784, 113 USPQ 289, 293 (CCPA 1957).

---SECTION---2133.03(e)(6) Permitted Experimental Activity and Testing

DEVELOPMENTAL TESTING IS PERMITTED

Testing of an invention in the normal context of its technological
development is generally within the realm of permitted experimental
activity. Likewise, experimentation to determine utility, as that term
is applied in  35 U.S.C. 101, may also constitute permissible activity.
See General Motors Corp. v. Bendix Aviation Corp., 123 F. Supp. 506,
521, 102 USPQ 58, 69 (N.D.Ind. 1954). For example, where an invention
relates to a chemical composition with no known utility, i.e., a patent
application for the composition could not be filed (35 U.S.C. 101;  35
U.S.C. 112, first paragraph), continued testing to find utility would
likely be permissible under  35 U.S.C. 102(b), absent a sale of the
composition or other evidence of commercial exploitation.

MARKET TESTING IS NOT PERMITTED

Experimentation to determine product acceptance, i.e., market testing,
is typical of a trader's and not an inventor's experiment and is thus
not within the area of permitted experimental activity. Smith & Davis
Mfg. Co. v. Mellon, 58 F. 705, 707 (8th Cir. 1893) Likewise, testing of
an invention for the benefit of appeasing a customer, or to conduct
"minor `tune up' procedures not requiring an inventor's skills, but
rather the skills of a competent technician," are also not within the
exception. In re Theis, 610 F.2d 786, 793, 204 USPQ 188, 193-94 (CCPA
1979).

EXPERIMENTAL ACTIVITY IN THE CONTEXT OF DESIGN APPLICATIONS

The public use of an ornamental design which is directed toward
generating consumer interest in the aesthetics of the design is not an
experimental use. In re Mann, 861 F.2d 1581, 8 USPQ2d 2030 (Fed. Cir.
1988) (display of a wrought iron table at a trade show held to be public
use). However, "experimentation directed to functional features of a
product also containing an ornamental design may negate what otherwise
would be considered a public use within the meaning of section 102(b)."
Tone Brothers, Inc. v. Sysco Corp., 28 F.3d 1192, 1196,  31 USPQ2d 1321,
1326 (Fed. Cir. 1994) (A study wherein students evaluated the effect of
the functional features of a spice container design may be considered an
experimental use.).

---SECTION---2133.03(e)(7) Activity of an Independent Third Party
Inventor

EXPERIMENTAL USE EXCEPTION IS PERSONAL TO AN APPLICANT

The statutory bars of  35 U.S.C. 102(b) are applicable even though
public use or on sale activity is by a party other than an applicant.
Where an applicant presents evidence of experimental activity by such
other party, the evidence will not overcome the prima facie case under 
35 U.S.C. 102(b) based upon the activity of such party unless the
activity was under the supervision and control of the applicant.
Magnetics v. Arnold Eng'g Co., 438 F.2d 72, 74, 168 USPQ 392, 394 (7th
Cir. 1971),   Bourne v. Jones, 114 F.Supp. 413, 419, 98 USPQ 206, 210
(S.D. Fla. 1951), aff'd., 207 F.2d 173, 98 USPQ 205 (5th Cir. 1953),
cert. denied, 346 U.S. 897, 99 USPQ 490 (1953); contra, Watson v. Allen,
254 F.2d 342, 117 USPQ 68 (D.C.Cir. 1957). In other words, the
experimental use activity exception is personal to an applicant.

---SECTION---2134 35 U.S.C. 102(c)

35 U.S.C. 102 Conditions for patentability; novelty and loss of right to
patent.

A person shall be entitled to a patent unless -

                  +++    

(c) he has abandoned the invention.

                  +++    

UNDER 35 U.S.C. 102(c), AN ABANDONMENT MUST BE INTENTIONAL

"Actual abandonment under  35 U.S.C. 102(c) requires that the inventor
intend to abandon the invention, and intent can be implied from the
inventor's conduct with respect to the invention. In re Gibbs, 437 F.2d
486, 168 USPQ 578 (CCPA 1971). Such intent to abandon the invention will
not be imputed, and every reasonable doubt should be resolved in favor
of the inventor." Ex parte Dunne, 20 USPQ2d 1479 (Bd. Pat. App. & Inter.
1991).

DELAY IN MAKING FIRST APPLICATION

Abandonment under  35 U.S.C. 102(c) requires a deliberate, though not
necessarily express, surrender of any rights to a patent. To abandon the
invention the inventor must intend a dedication to the public. Such
dedication may be either express or implied, by actions or inactions of
the inventor. Delay alone is not sufficient to infer the requisite
intent to abandon. Moore v. United States, 194 USPQ 423, 428 (Ct. Cl.
1977) (The drafting and retention in his own files of two patent
applications by inventor indicates an intent to retain his invention;
delay in filing the applications was not sufficient to establish
abandonment); but see Davis Harvester Co., Inc. v. Long Mfg. Co., 252 F.
Supp. 989, 1009-10, 149 USPQ 420, 435-436 (E.D. N.C. 1966) (Where the
inventor does nothing over a period of time to develop or patent his
invention, ridicules the attempts of another to develop that invention
and begins to show active interest in promoting and developing his
invention only after successful marketing by another of a device
embodying that invention, the inventor has abandoned his invention under 
35 U.S.C. 102(c).).

DELAY IN REAPPLYING FOR PATENT AFTER ABANDONMENT OF PREVIOUS PATENT
APPLICATION

Where there is no evidence of expressed intent or conduct by inventor to
abandon his invention, delay in reapplying for patent after abandonment
of a previous application does not constitute abandonment under  35
U.S.C. 102(c). Petersen v. Fee Int'l, Ltd., 381 F. Supp. 1071, 182 USPQ
264 (W.D. Okla. 1974).

DISCLOSURE WITHOUT CLAIMING IN A PRIOR ISSUED PATENT

Any inference of abandonment (i.e., intent to dedicate to the public) of
subject matter disclosed but not claimed in a previously issued patent
is rebuttable by an application filed at any time before a statutory bar
arises. Accordingly, a rejection of a claim of a patent application
under  35 U.S.C. 102(c) predicated solely on the issuance of a patent
which discloses the subject matter of the claim in the application
without claiming it would be improper, regardless of whether there is
copendency between the application at issue and the application which
issued as the patent. In re Gibbs, 437 F.2d 486, 168 USPQ 578 (CCPA
1971).

ONLY WHEN THERE IS A PRIORITY CONTEST CAN A LAPSE OF TIME BAR A PATENT

The mere lapse of time will not bar a patent. The only exception is when
there is a priority contest under  35 U.S.C. 102(g) and applicant
abandons, suppresses or conceals the invention. Panduit Corp. v.
Dennison Mfg. Co., 774 F.2d 1082, 1101, 227 USPQ 337, 350 (Fed. Cir.
1985). Abandonment, suppression and concealment are treated by the
courts under 35 U.S.S. 102(g). See MPEP Section  2138.03 for more
information on this issue.

---SECTION---2135 35 U.S.C. 102(d)

35 U.S.C. 102 Conditions for patentability; novelty and loss of right to
patent.

A person shall be entitled to a patent unless -

                  +++    

(d) the invention was first patented or caused to be patented, or was
the subject of an inventor's certificate, by the applicant or his legal
representatives or assigns in a foreign country prior to the date of the
application for patent in this country on an application for patent or
inventor's certificate filed more than twelve months before the filing
of the application in the United States.

                  +++    

GENERAL REQUIREMENTS OF 35 U.S.C. 102(d)

35 U.S.C. 102(d) establishes four conditions which, if all are present,
establish a bar against the granting of a patent in this country:

(A) The foreign application must be filed more than 12 months before the
effective U.S. filing date (See MPEP Section  706.02 regarding effective
U.S. filing date of an application);

(B) The foreign application must have been filed by the same applicant
as in the United States or by his or her legal representatives or
assigns.

(C) The foreign patent or inventor's certificate must be actually
granted (e.g., by sealing of the papers in Great Britain) before the
U.S. filing date. It need not be published.

(D) The same invention must be involved.

If such a foreign patent or inventor's certificate is discovered by the
examiner, the rejection is made under  35 U.S.C. 102(d) on the ground of
statutory bar. See MPEP Section  2135.01 for further clarification of
each of the four requirements of  35 U.S.C. 102(d).

---SECTION---2135.01 The Four Requirements of  35 U.S.C. 102(d)

I. FOREIGN APPLICATION MUST BE FILED MORE THAN 12 MONTHS BEFORE THE
EFFECTIVE U.S. FILING DATE

A. An Anniversary Date Ending on a Weekend or Holiday Results in an
Extension to the Next Business Day

The U.S. application is filed in time to prevent a  35 U.S.C. 102(d) bar
from arising if it is filed on the 1 year anniversary date of the filing
date of the foreign application. If this day is a Saturday, Sunday or
Federal holiday, the year would be extended to the following business
day. See Ex parte Olah, 131 USPQ 41 (Bd. App. 1960.)  Despite changes to 
37 CFR 1.6(a)(2) and 1.10, which require the PTO to accord a filing date
to an application as of the date of deposit as "Express Mail" with the
U.S. Postal Service in accordance with  37 CFR 1.10 (e.g., a Saturday
filing date), the rule changes do not affect applicant's concurrent
right to defer the filing of an application until the next business day
when the last day for "taking any action" falls on a Saturday, Sunday,
or a Federal holiday (e.g., the last day of the 1-year grace period
falls on a Saturday).

B. A Continuation-in-Part Breaks the Chain of Priority as to Foreign as
Well as U.S. Parents

In the case where applicant files a foreign application, later files a
U.S. application claiming priority based on the foreign application, and
then files a continuation-in-part (CIP) application whose claims are not
entitled to the filing date of the U.S. parent, the effective filing
date is the filing date of the CIP and applicant cannot obtain the
benefit of either the U.S. parent or foreign application filing dates.
In re Van Langenhoven, 458 F.2d 132, 137, 173 USPQ 426, 429 (CCPA 1972).
If the foreign application issues into a patent before the filing date
of the CIP, it may be used in a  35 U.S.C. 102(d)/103 rejection if the
subject matter added to the CIP does not render the claims nonobvious
over the foreign patent. Ex parte Appeal No. 242-47, 196 USPQ 828 (Bd.
App. 1976) (Foreign patent can be combined with other prior art to bar a
U.S. patent in an obviousness rejection based on  35 U.S.C. 102(d)/103).

II. FOREIGN APPLICATION MUST HAVE BEEN FILED BY SAME APPLICANT, HIS OR
HER LEGAL REPRESENTATIVE OR ASSIGNS

Note that where the U.S. application was made by two or more inventors,
it is permissible for these inventors to claim priority from separate
applications, each to one of the inventors or a subcombination of
inventors. For instance, a U.S. application naming inventors A and B may
be entitled to priority from one application to A and one to B filed in
a foreign country.

III. THE FOREIGN PATENT OR INVENTOR'S CERTIFICATE WAS ACTUALLY GRANTED
BEFORE THE U.S. FILING DATE

A. To Be "Patented" an Exclusionary Right Must Be Awarded to the
Applicant

"Patented" means "a formal bestowal of patent rights from the sovereign
to the applicant." In re Monks, 588 F.2d 308, 310, 200 USPQ 129, 131
(CCPA 1978); American Infra-Red Radiant Co. v. Lambert Indus., 360 F.2d
977, 149 USPQ 722 (8th Cir.), cert. denied, 385 U.S. 920 (1966) (German
Gebrauchsmuster petty patent was held to be a patent usable in a  35
U.S.C. 102(d) rejection. Gebrauchmustern are not examined and only grant
a 6-year patent term. However, except as to duration, the exclusionary
patent right granted is as extensive as in the U.S.).

B. A Published Application Is Not a "Patent"

An application must issue into a patent before it can be applied in a 
35 U.S.C. 102(d) rejection. Ex parte Fujishiro, 199 USPQ 36 (Bd. App.
1977) ("Patenting," within the meaning of  35 U.S.C. 102(d), does not
occur upon laying open of a Japanese utility model application (kokai or
kohyo)); Ex parte Links, 184 USPQ 429 (Bd. App. 1974) (German
applications, which have not yet been published for opposition, are
published in the form of printed documents called Offenlegungsschriften
18 months after filing. These applications are unexamined or in the
process of being examined at the time of publication. The Board held
that an Offenlegungsschrift is not a patent under  35 U.S.C. 102(d) even
though some provisional rights are granted. The court explained that the
provisional rights are minimal and do not come into force if the
application is withdrawn or refused.).

C. An Allowed Application Can Be a "Patent" for Purposes of 35 U.S.C.
102(d) as of the Date Published for Opposition Even Though It Has Not
Yet Been Granted as a Patent

An examined application which has been allowed by the examiner and
published to allow the public to oppose the grant of a patent has been
held to be a "patent" for purposes of rejection under  35 U.S.C. 102(d)
as of the date of publication for opposition if substantial provisional
enforcement rights arise. Ex parte Beik, 161 USPQ 795 (Bd. App. 1968)
(This case dealt with examined German applications. After a
determination that an application is allowable, the application is
published in the form of a printed document called an Auslegeschrift.
The publication begins a period of opposition were the public can
present evidence showing unpatentability. Provisional patent rights are
granted which are substantially the same as those available once the
opposition period is over and the patent is granted. The Board found
that an Auslegeschrift provides the legal effect of a patent for
purposes of rejection under  35 U.S.C. 102(d).).

D. Grant Occurs when Patent Becomes Enforceable

The critical date of a foreign patent as a reference under  35 U.S.C.
102(d) is the date the patent becomes enforceable (issued, sealed or
granted). In re Monks, 588 F.2d 308, 310, 200 USPQ 129, 131 (CCPA 1978)
(British reference became available as prior art on date the patent was
"sealed" because as of this date applicant had the right to exclude
others from making, using or selling the claimed invention.).

E. 35 U.S.C. 102(d) Applies as of Grant Date Even If There Is a Period
of Secrecy After Patent Grant

A period of secrecy after granting the patent, as in Belgium and Spain,
has been held to have no effect in connection with  35 U.S.C. 102(d).
These patents are usable in rejections under  35 U.S.C. 102(d) as of the
date patent rights are granted. In re Kathawala, 9 F.3d 942, 28 USPQ2d
1789 (Fed. Cir. 1993) (An invention is "patented" for purposes of  35
U.S.C. 102(d) when the patentee's rights under the patent become fixed.
The fact that applicant's Spanish application was not published until
after the U.S. filing date is immaterial since the Spanish patent was
granted before U.S. filing.); Gramme Elec. Co. v. Arnoux and Hochhausen
Elec. Co., 17 F. 838, 1883 C.D. 418 (S.D.N.Y. 1883) (Rejection made
under a predecessor of  35 U.S.C. 102(d) based on an Austrian patent
granted an exclusionary right for 1 year but was kept secret, at the
option of the patentee, for that period. The court held that the
Austrian patent grant date was the relevant date under the statute for
purposes of  35 U.S.C. 102(d) but that the patent could not have been
used to in a rejection under  35 U.S.C. 102(a) or (b).);   In re
Talbott, 443 F.2d 1397, 170 USPQ 281 (CCPA 1971) (Applicant cannot avoid
a  35 U.S.C. 102(d) rejection by exercising an option to keep the
subject matter of a German Gebrauchsmuster (petty patent) in secrecy
until time of U.S. filing.).

IV. THE SAME INVENTION MUST BE INVOLVED

 "Same Invention" Means That the Application Claims Could Hsve Been
Presented in the Foreign Patent

Under  35 U.S.C. 102(d), the "invention... patented" in the foreign
country must be the same as the invention sought to be patented in the
U.S. When the foreign patent contains the same claims as the U.S.
application, there is no question that "the invention was first
patented... in a foreign country." In re Kathawala, 9 F.3d 942, 945, 28
USPQ2d 1785, 1787 (Fed. Cir. 1993). However, the claims need not be
identical or even within the same statutory class. If applicant is
granted a foreign patent which fully discloses the invention and which
gives applicant a number of different claiming options in the U.S., the
reference in  35 U.S.C. 102(d) to " `invention... patented' necessarily
includes all the disclosed aspects of the invention. Thus, the section
102(d) bar applies regardless whether the foreign patent contains claims
to less than all aspects of the invention." 9 F.3d at 946, 28 USPQ2d at
1788. In essence, a  35 U.S.C. 102(d) rejection applies if applicant's
foreign application supports the subject matter of the U.S. claims. In
re Kathawala, 9 F.3d 942, 28 USPQ2d 1785 (Fed. Cir. 1993) (Applicant was
granted a Spanish patent claiming a method of making a composition. The
patent disclosed compounds, methods of use and processes of making the
compounds. After the Spanish patent was granted, the applicant filed a
U.S. application with claims directed to the compound but not the
process of making it. The Federal Circuit held that it did not matter
that the claims in the U.S. application were directed to the composition
instead of the process because the foreign specification would have
supported claims to the composition. It was immaterial that the
formulations were unpatentable pharmaceutical compositions in Spain.).

---SECTION---2136 35 U.S.C. 102(e)

35 U.S.C. 102 Conditions for patentability; novelty and loss of right to
patent.

A person shall be entitled to a patent unless-

                  +++    

(e) the invention was described in a patent granted on an application
for patent by another filed in the United States before the invention
thereof by the applicant for patent, or on an international application
by another who has fulfilled the requirements of paragraphs (1), (2),
and (4) of section 371(c) of this title before the invention thereof by
the applicant for patent.

                  +++    

ONLY U.S. PATENTS AND SIRS ARE ELIGIBLE AS PRIOR ART UNDER 35 U.S.C.
102(e)

The reference must be a U.S. patent to be eligible for use in a  35
U.S.C. 102(e) rejection. Ex parte Smolka, 207 USPQ 232 (Bd. App. 1980)
(A foreign patent document with priority back to an abandoned U.S.
application cannot be the basis for a  35 U.S.C. 102(e) rejection. The
foreign document cannot be prior art until it is patented or
published.). Statutory Invention Registrations (SIRS)  can also be used
in  35 U.S.C. 102(e) rejections as of their filing dates.

DEFENSIVE PUBLICATIONS ARE NOT PRIOR ART AS OF THEIR FILING DATE

A defensive publication is not a patent, it is a publication. Therefore,
it is prior art only as of its publication date. Ex parte Osmond, 191
USPQ 334 (Bd. App. 1973) (Examiner rejected the claims over Defensive
Publication T-858,018 issued by the PTO to Jacobson. The examiner made a 
35 U.S.C. 102(a) rejection contending that a defensive publication can
be used as a reference under  35 U.S.C. 102(a) as of its filing date.
This position was authorized at that time by the MPEP and a
Commissioner's Notice establishing the Defensive Publication Program.
The Board found that in order for a  35 U.S.C. 102(a) rejection to
apply, the reference must be of public knowledge and a Defensive
Publication is not public knowledge at the time of its filing. Thus, the
Board reversed the rejection. The Board also found that  35 U.S.C.
102(e) could not be used as a basis for rejection because the use of
Defensive Publications as of their filing dates was not supported by
section 102(e).) See MPEP Section  711.06(a) for more information on
Defensive Publications as references.

---SECTION---2136.01 Status of U.S. Patent as a Reference Before and
After Issuance

WHEN THERE IS NO COMMON ASSIGNEE OR INVENTOR, AN APPLICATION MUST ISSUE
AS A PATENT BEFORE IT IS AVAILABLE AS PRIOR ART UNDER 35 U.S.C. 102(e)

Generally, a U.S. patent must issue before it can be used as a reference
in a  35 U.S.C. 102(e) rejection. Ex parte Smolka, 207 USPQ 232 (Bd.
App. 1980) (An application to Smolka and Schwuger was rejected over  35
U.S.C. 102(e) based on a pending U.S. application to Corkill whose
filing date antedated the Smolka et al. application. A German
application corresponding to the Corkill application had been published,
but did not antedate the effective filing date of the Smolka   et al.
application. The Board reversed the rejection holding that a U.S. patent
had to be issued to Corkill before it could become available as prior
art under  35 U.S.C. 102(e). There was no common assignee nor any common
inventor between the two applications.).

WHEN THERE IS A COMMON ASSIGNEE OR INVENTOR, A PROVISIONAL 35 U.S.C.
102(e) REJECTION OVER AN EARLIER FILED APPLICATION CAN BE MADE

Based on the assumption that an application will ripen into a U.S.
patent, it is permissible to provisionally reject a later application
over an earlier application under  35 U.S.C. 102(e). In re Irish, 433
F.2d 1342, 167 USPQ 764 (CCPA 1970). Such a provisional rejection
"serves to put applicant on notice at the earliest possible time of the
possible prior art relationship between copending applications" and
gives applicant the fullest opportunity to overcome the rejection by
amendment or submission of evidence. In addition, since both
applications are pending and usually have the same assignee, more
options are available to applicant for overcoming the provisional
rejection than if the other application were already issued. Ex parte
Bartfeld, 16 USPQ2d 1714 (Bd. Pat. App. & Int. 1990) aff'd on other
grounds, 925 F.2d 1450,  17 USPQ2d 1885 (Fed. Cir. 1991). Note that
provisional rejections over  35 U.S.C. 102(e) are only authorized when
there is a common inventor or assignee, otherwise the copending
application must remain confidential.  MPEP Section  706.02(f) and
Section  706.02(k) discuss the procedures to be used in provisional
rejections over  35 U.S.C. 102(e) and 103.

---SECTION---2136.02 Content of the Prior Art Available Against the
Claims

A 35 U.S.C. 102(e) REJECTION MAY RELY ON ANY PART OF THE PATENT
DISCLOSURE

Under  35 U.S.C. 102(e), the entire disclosure of a U.S. patent having
an earlier filing date can be relied on to reject the claims. Sun Studs,
Inc. v. ATA Equip. Leasing, Inc., 872 F.2d 978, 983, 10 USPQ2d 1338,
1342 (Fed. Cir. 1989).

U.S. PATENT REFERENCE MUST ITSELF CONTAIN THE SUBJECT MATTER RELIED ON
IN THE REJECTION

When a U.S. patent is used to reject claims under  35 U.S.C. 102(e), the
disclosure relied on in the rejection must be present in the issued
patent. It is the filing date of the U.S. patent being relied on as the
critical reference date and subject matter not included in the patent
itself can only be used when that subject matter becomes public.
Portions of the patent application which were canceled are not part of
the patent and thus cannot be relied on in a  35 U.S.C. 102(e) rejection
over the issued patent. Ex Parte Stalego, 154 USPQ 52 (Bd. App. 1966).
Likewise, subject matter which is disclosed in a parent application, but
not included in the child continuation-in-part (CIP) cannot be relied on
in a  35 U.S.C. 102(e) rejection over the issued CIP. In re Lund, 376
F.2d 982, 153 USPQ 625 (CCPA 1967) (The examiner made a  35 U.S.C.
102(e) rejection over an issued U.S. patent which was a
continuation-in-part (CIP). The parent application of the U.S. patent
reference contained an example II which was not carried over to the CIP.
The court held that the subject matter embodied in the canceled example
II could not be relied on as of either parent or child filing date.
Thus, the use of example II subject matter to reject the claims under 
35 U.S.C. 102(e) was improper.).

THE SUPREME COURT HAS AUTHORIZED 35 U.S.C. 103 REJECTIONS BASED ON 35
U.S.C. 102(e)

U.S. patents may be used as of their filing dates to show that the
claimed subject matter is anticipated or obvious. Obviousness can be
shown by combining other prior art with the U.S. patent reference in a 
35 U.S.C. 103 rejection. Hazeltine Research v. Brenner, 382 U.S. 252,
147 USPQ 429 (1965).

---SECTION---2136.03 Critical Reference Date

I. FOREIGN PRIORITY DATE

Reference's Foreign Priority Date Under 35 U.S.C. 119(a)-(d) Cannot Be
Used as the 35 U.S.C. 102(e) Reference Date

A U.S. patent reference is effective prior art as of its U.S. filing
date.  35 U.S.C. 119(a)-(d) does not modify section 102(e) which is
explicitly limited to patent references "filed in the United States
before the invention thereof by the applicant" (emphasis added).
Therefore, the foreign priority date of the reference under  35 U.S.C.
119(a)-(d) cannot be used to antedate the application filing date. In
contrast, applicant may be able to overcome the  35 U.S.C. 102(e)
rejection by proving he or she is entitled to his or her own  35 U.S.C.
119 priority date which is earlier than the reference's U.S. filing
date. In re Hilmer, 359 F.2d 859, 149 USPQ 480 (CCPA 1966) (Hilmer I)
(Applicant filed an application with a right of priority to a German
application. The examiner rejected the claims over a U.S. patent to
Habicht based on its Swiss priority date. The U.S. filing date of
Habicht was later than the application's German priority date. The court
held that the reference's Swiss priority date could not be relied on in
a  35 U.S.C. 102(e) rejection.  Because the U.S. filing date of Habicht
was later than the earli est effective filing date (German priority
date) of the application, the rejection was reversed.). See MPEP Section 
201.15 for information on procedures to be followed in considering
applicant's right of priority.

II. INTERNATIONAL (PCT) FILING DATE

Reference's International Filing Date Can Be Used as the 35 U.S.C.
102(e) Reference Date

Where a U.S. application filed under  35 U.S.C. 111(a) claims the
benefit of the filing date of a copending PCT international application
under  35 U.S.C. 120, its effective date as a reference under  35 U.S.C.
102(e) is the international filing date as defined by  35 U.S.C. 363. 
See  35 U.S.C. 365(c).  However, when a U.S. national stage application
filed under  35 U.S.C. 371 becomes a U.S. patent, the  35 U.S.C. 102(e)
date of the U.S. Patent as a prior art reference is the date applicant
fulfilled the requirements of  35 U.S.C. 371(c)(1), (c)(2), and (c)(4).
See MPEP Section  715 and Section  1896.

III. PRIORITY FROM PROVISIONAL APPLICATION UNDER 35 U.S.C. 119(e)

The  35 U.S.C. 102(e) critical reference date of a U.S. patent entitled
to the benefit of the filing date of a provisional application under  35
U.S.C. 119(e) is the filing date of the provisional application, except
in the case of a U.S. patent granted on an international (PCT)
application in which the requirements of paragraphs (1), (2) and (4) of 
35 U.S.C. 371(c) have been fulfilled. By the terms of  35 U.S.C. 102(e),
the critical reference date of a U.S. patent granted on such a  35
U.S.C. 371 application is the date on which paragraphs (c)(1), (c)(2)
and (c)(4) have been fulfilled, not the filing date of the provisional
application.

IV. PARENT'S FILING DATE WHEN REFERENCE IS A CONTINUATION-IN-PART OF THE
PARENT

Filing Date of U.S. Parent Application Can Only Be Used as the 35 U.S.C.
102(e) Date If It Supports the Claims of the Issued Child

In order to carry back the  35 U.S.C. 102(e) critical date of the U.S.
patent reference to the filing date of a parent application, the parent
application must (A) have a right of priority to the earlier date under 
35 U.S.C. 120 and (B) support the invention claimed as required by  35
U.S.C. 112, first paragraph. "For if a patent could not theoretically
have issued the day the application was filed, it is not entitled to be
used against another as `secret prior art' " under  35 U.S.C. 102(e). In
re Wertheim, 646 F.2d 527, 537, 209 USPQ 554, 564 (CCPA 1981) (The
examiner made a  35 U.S.C. 103 rejection over a U.S. patent to Pfluger.
The Pfluger patent (Pfluger IV) was the child of a string of abandoned
parent applications (Pfluger I, the first application, Pfluger II and
III, both CIPs). Pfluger IV was a continuation of Pfluger III. The court
characterized the contents of the applications as follows: Pfluger I -
subject matter A, II-AB, III-ABC, IV-ABC. ABC anticipated the claims of
the examined application, but the filing date of III was later than the
application filing date. So the examiner reached back to "A" in Pfluger
I and combined this disclosure with another reference to establish
obviousness. The court held that the examiner impermissibly carried over
"A" and should have instead determined which of the parent applications
contained the subject matter which made Pfluger patentable. Only if B
and C were not claimed, or at least not critical to the patentability of
Pfluger IV, could the filing date of Pfluger I be used. The court
reversed the rejection based on a determination that Pfluger IV was only
entitled to the Pfluger III filing date. The added new matter (C) was
critical to the claims of the issued patent.). Note that In re Wertheim
modified the holding of In re Lund, 376 F.2d 982, 153 USPQ 625 (CCPA
1967) as to "carrying back" the subject matter to the parent
applications.

See also Ex parte Gilderdale, 1990 Pat. App. LEXIS 25 (Bd. Pat. App. &
Inter. Appeal no. 89-0352) (The examiner made a  35 U.S.C. 102(e)
rejection over a U.S. patent to Hernandez   et al. Hernandez   et al.
was a continuation of a continuation-in-part. Both the parent and
grandparent had been abandoned. The parent listed a different inventive
entity but supported the subject matter of the child's claims. The
parent was filed on the same day as the examined application and thus no 
35 U.S.C. 102(e) rejection could be made based on the parent's filing
date. The Board reversed the rejection, explaining that the Hernandez
patent was entitled to the filing date of its parent, as the parent
supported the patent claims and  35 U.S.C. 120 was satisfied. Under  35
U.S.C. 120, an application can claim the benefit of an earlier filing
date even if not all inventors are the same. However, Hernandez was not
entitled to the grandparent filing date because the parent and child
applications contained new matter as compared to the grandparent.).

Compare Ex parte Ebata, 19 USPQ2d 1952 (Bd. Pat. App. & Inter. 1991)
(The claims were directed to a method of administering a salt of
lysocellin to animals. A  35 U.S.C. 102(e) rejection was made over
Martin. Martin was a continuation of an application which was in turn a
continuation-in-part of an abandoned application. The grandparent
application disclosed administering a manganese complex of lysocellin to
animals. The Board found that "the new matter relates to additional
forms of lysocellin which are useful in Martin's process, i.e., species
or embodiments other than the manganese complex. This is far different
from adding limitations which are required or necessary for
patentability." Unlike the situation in In re Wertheim, Martin's
invention was patentable as presented in the grandparent application.).

V. DATE OF CONCEPTION OR REDUCTION TO PRACTICE

 35 U.S.C. 102(e) Reference Date Is the Filing Date Not Date of
Patentee's Conception or Reduction to Practice

If the U.S. patent applied as a  35 U.S.C. 102(e) reference discloses,
but does not claim the subject matter of the claims being examined or an
obvious variant, the patent is not prior art under  35 U.S.C. 102(g).
When the cases are not in interference, the effective date of the
reference U.S. patent as prior art is its filing date in the United
States, as stated in  35 U.S.C. 102(e). The date that the prior art U.S.
patent subject matter was conceived or reduced to practice is of no
importance when  35 U.S.C. 102(g) is not at issue. Sun Studs, Inc. v.
ATA Equip. Leasing,   Inc., 872 F.2d 978, 983, 10 USPQ2d 1338, 1342
(Fed. Cir. 1989) (The defendant sought to invalidate patents issued to
Mason and Sohn assigned to Sun Studs. The earliest of these patents
issued in June 1973. A U.S. patent to Mouat was found which issued in
March 1976 and which disclosed the invention of Mason and Sohn. While
the patent to Mouat issued after the Mason and Sohn patents, it was
filed 7 months earlier than the earliest of the Mason and Sohn patents.
Sun Studs submitted affidavits showing conception in 1969 and diligence
to the constructive reduction to practice and therefore antedated the
patent to Mouat. The defendant sought to show that Mouat conceived the
invention in 1966. The court held that conception of the subject matter
of the reference only becomes an issue when the claims of the
conflicting patents cover inventions which are the same or obvious over
one another. When  35 U.S.C. 102(e) applies but not  35 U.S.C. 102(g),
the filing date of the prior art patent is the earliest date that can be
used to reject or invalidate claims.).

---SECTION---2136.04 Different Inventive Entity; Meaning of "By Another"

IF THERE IS ANY DIFFERENCE IN THE INVENTIVE ENTITY, THE PATENT REFERENCE
IS "BY ANOTHER"

"Another" means other than applicants, In re Land, 368 F.2d 866,  151
USPQ 621 (CCPA 1966), in other words, a different inventive entity. The
inventive entity is different if not all inventors are the same. The
fact that the application and patent have one or more inventors in
common is immaterial. Ex parte DesOrmeaux, 25 USPQ2d 2040 (Bd. Pat. App.
& Inter. 1992) (The examiner made a  35 U.S.C. 102(e) rejection based on
an issued U.S. patent to three inventors. The rejected application was a
continuation-in-part of the issued parent with an extra inventor. The
Board found that the patent was "by another" and thus could be used in a 
35 U.S.C. 102(e)/103 rejection of the application.).

A DIFFERENT INVENTIVE ENTITY IS PRIMA FACIE EVIDENCE THAT THE U.S.
PATENT IS "BY ANOTHER"

As stated by the House and Senate reports on the bills enacting section 
35 U.S.C. 102(e), this subsection of 102 codifies the Milburn rule of
Milburn v. Davis- Bournonville, 270 U.S. 390 (1926). The Milburn rule
authorized the use of a U.S. patent containing a disclosure of the
invention as a reference against a later filed application as of the
U.S. patent filing date. The existence of an earlier filed U.S.
application containing the subject matter claimed in the application
being examined indicates that applicant was not the first inventor.
Therefore, a U.S. patent by a different inventive entity, whether or not
the application shares some inventors in common with the patent, is
prima facie evidence that the invention was made "by another" as set
forth in section 102(e). In re Mathews, 408 F.2d 1393, 161 USPQ 276
(CCPA 1969); In re Facius, 408 F.2d 1396, 161 USPQ 294 (CCPA 1969); Ex
parte DesOrmeaux, 25 USPQ2d 2040 (Bd. Pat. App. & Inter. 1992). See MPEP
Section  2136.05 for discussion of methods of overcoming 102(e)
rejections.

---SECTION---2136.05 Overcoming a Rejection Under  35 U.S.C. 102(e)

A 35 U.S.C. 102(e) REJECTION CAN BE OVERCOME BY ANTEDATING THE FILING
DATE OR SHOWING THAT DISCLOSURE RELIED ON IS APPLICANT'S OWN WORK

When a prior U.S. patent is not a statutory bar, a  35 U.S.C. 102(e)
rejection can be overcome by antedating the filing date (see MPEP
Section  2136.03 regarding critical reference date of a U.S. patent) of
the U.S. patent reference by submitting an affidavit or declaration
under  37 CFR 1.131 or by submitting an affidavit or declaration under 
37 CFR 1.132 establishing that the relevant disclosure is applicant's
own work. In re Mathews, 408 F.2d 1393, 161 USPQ 276 (CCPA 1969). The
filing date can also be antedated by applicant's earlier foreign
priority application or provisional application if  35 U.S.C. 119 is met
and the foreign application or provisional application "supports"
(conforms to  35 U.S.C. 112, first paragraph, requirements) all the
claims of the U.S. application. In re Gosteli, 872 F.2d 1008, 10 USPQ2d
1614 (Fed. Cir. 1989). But a prior application which was not copending
with the application at issue cannot be used to antedate a reference. In
re Costello, 717 F.2d 1346, 219 USPQ 389 (Fed. Cir. 1983). A terminal
disclaimer also does not overcome a  35 U.S.C. 102(e) rejection. In re
Bartfeld, 925 F.2d 1415, 17 USPQ2d 1885 (Fed. Cir. 1991) (The examiner
made a provisional  35 U.S.C. 102(e)/103 rejection over a commonly owned
copending application with a different inventive entity. The rejected
application was a continuation-in-part (CIP) of the reference
application. Applicants argued that the terminal disclaimer they had
submitted should be effective to overcome the  35 U.S.C. 102(e)/103
rejection because Congress enacted 35 U.S.C. 103(c) to foster free
exchange of ideas and concepts at universities and corporate research
centers by prohibiting the use of "secret prior art" in making obvious
determinations when the subject matter originates in the same
organization. The court responded by explaining that the plain language
of  35 U.S.C. 103(c) says that "subject matter developed by another
person, which qualifies as prior art only under subsection (f) or (g) of
section 102 does not preclude patentability" (emphasis added).
Therefore, rejections under  35 U.S.C. 102(e) are not covered by  35
U.S.C. 103(c) and a terminal disclaimer will not remove the  35 U.S.C.
102(e)/103 rejection.).

See MPEP Section  706.02(b) for a list of methods which can be used to
overcome rejections based on  35 U.S.C. 102(e) rejections. For
information on the required contents of a  37 CFR 1.131 affidavit or
declaration and the situations in which such affidavits and declarations
are permitted see MPEP Section  715. An affidavit or declaration is not
appropriate if the reference describes applicant's own work. In this
case, applicant must submit an affidavit or declaration under  37 CFR
1.132. See the next paragraph for more information concerning the
requirements of  37 CFR 1.132 affidavits and declarations.

A 35 U.S.C. 102(e) REJECTION CAN BE OVERCOME BY SHOWING THE PATENT IS
DESCRIBING APPLICANT'S OWN WORK

"The fact that an application has named a different inventive entity
than a patent does not necessarily make that patent prior art." Applied
Materials Inc. v. Gemini Research Corp., 835 F.2d 279, 15 USPQ2d 1816
(Fed. Cir. 1988). The issue turns on what the evidence of record shows
as to who invented the subject matter. In re Whittle, 454 F.2d 1193,
1195, 172 USPQ 535, 537 (CCPA 1972). In fact, even if applicant's work
was publicly disclosed prior to his or her application, applicant's own
work may not be used against him or her unless there is a time bar under 
35 U.S.C. 102(b). In re DeBaun, 687 F.2d 459, 214 USPQ 933 (CCPA 1982)
(citing In re Katz, 687 F.2d 450, 215 USPQ 14 (CCPA 1982)). Therefore,
when the unclaimed subject matter of a patent is applicant's own
invention, applicant may overcome a prima facie case based on the patent
by showing that the patent disclosure is a description of applicant's
own previous work. Such a showing can be made by proving that the
patentee was associated with applicant (e.g. worked for the same
company) and learned of applicant's invention from applicant. In re
Mathews, 408 F.2d 1393, 161 USPQ 276 (CCPA 1969). In the situation where
one application is first filed by inventor X and then a later
application is filed by X&Y, it must be proven that the joint invention
was made first, was thereafter described in the sole applicant's patent
and then the joint application was filed. In re Land, 368 F.2d 866, 151
USPQ 621 (CCPA 1966).

In In re Land, separate U.S. patents to Rogers and to Land were used to
reject a joint application to Rogers and Land under  35 U.S.C.
102(e)/103. The inventors worked for the same company (Polaroid) and in
the same laboratory. All the patents flowed from the same research. In
addition, the patent applications were prepared by the same attorneys,
were interrelated and contained cross-references to each other. The
court affirmed the rejection because (1) the inventive entities of the
patents (one to Rogers and one to Land) were different from the
inventive entity of the joint application (Rogers and Land) and (2) Land
and Rogers brought their knowledge of their individual work with them
when they made the joint invention. There was no indication that the
portions of the references relied on disclosed anything they did
jointly. Neither was there any showing that what they did   jointly was
done before the filing of the reference patent applications.

See also   In re Carreira, 532 F.2d 1356, 189 USPQ 461 (CCPA 1976) (The
examiner rejected claims to a joint application to Carreira, Kyrakakis,
Solodar, and Labana under  35 U.S.C. 102(e) and 103 in view of a U.S.
patent issued to Tulagin and Carreira or a patent issued to Clark. The
applicants submitted declarations under  37 CFR 1.132 by Tulagin and
Clark in which each declarant stated he was "not the inventor of the use
of compounds having a hydroxyl group in a position ortho to an azo
linkage." The court held that these statements were vague and
inconclusive because the declarants did not disclose the use of this
generic compound but rather species of this generic compound in their
patents and it was the species which met the claims. The declaration
that each did not invent the use of the generic compound does not
establish that Tulagin and Clark did not invent the use of the species.)

MPEP Section  715.01(a),  Section  715.01(c), and Section  716.10 set
forth more information pertaining to the contents and uses of affidavits
and declarations under  37 CFR 1.132 for antedating references.

APPLICANT NEED NOT SHOW DILIGENCE OR REDUCTION TO PRACTICE WHEN THE
SUBJECT MATTER DISCLOSED IN THE REFERENCE IS APPLICANT'S OWN WORK

When the U.S. patent reference reflects applicant's own work, applicant
need not prove diligence or reduction to practice to establish that he
or she invented the subject matter disclosed in the patent reference. A
showing that the reference disclosure arose from applicant's work
coupled with a showing of conception by the applicant before the filing
date of the reference will overcome the  35 U.S.C. 102(e) rejection. The
showing can be made by submission of an affidavit by the inventor under 
37 CFR 1.132. The other patentees need not submit an affidavit
disclaiming inventorship, but, if submitted, a disclaimer by all other
patentees should be considered by the examiner. In re DeBaun, 687 F.2d
459, 214 USPQ 933 (CCPA 1982) (Declaration submitted by DeBaun stated
that he was the inventor of subject matter disclosed in the U.S. patent
reference of DeBaun and Noll. Exhibits were attached to the declaration
showing conception and included drawings DeBaun had prepared and given
to counsel for purposes of preparing the application which issued as the
reference patent. The court held that, even though the evidence was not
sufficient to antedate the prior art patent under  37 CFR 1.131,
diligence and/or reduction to practice was not required to show DeBaun
invented the subject matter. Declarant's statement that he conceived the
invention first was enough to overcome the  35 U.S.C. 102(e)
rejection.).

CLAIMING OF INDIVIDUAL ELEMENTS OR SUBCOMBINATIONS IN A COMBINATION
CLAIM OF THE REFERENCE PATENT DOES NOT ITSELF ESTABLISH THAT THE
PATENTEE INVENTED THOSE ELEMENTS

The existence of combination claims in a U.S. patent is not evidence
that the patentee invented the individual elements or subcombinations
included if the elements and subcombinations are not separately claimed
apart from the combination. In re DeBaun, 687 F.2d 459, 214 USPQ 933
(CCPA 1982) (citing In re Facius, 408 F.2d 1396, 1406, 161 USPQ 294, 301
(CCPA 1969)).

See also In re Mathews, 408 F.2d 1393, 161 USPQ 276 (CCPA 1969) (On
September 15, 1961, Dewey filed an application disclosing and claiming a
time delay protective device for an electric circuit. In disclosing the
invention, Dewey completely described, but did not claim, a "gating
means 19" invented by Mathews which was usable in the protective device.
Dewey and Mathews were coworkers at General Electric Company, the
assignee. Mathews filed his application on March 7, 1963, before the
Dewey patent issued but almost 18 months after its filing. The Mathews
application disclosed that "one illustration of a circuit embodying the
present inven tion is shown in copending patent application S.N.
138,476-Dewey." The examiner used Dewey to reject all the Mathews claims
under  35 U.S.C. 102(e). In response, Mathews submitted an affidavit by
Dewey under  37 CFR 1.132. In the affidavit, Dewey stated that he did
not invent the gating means 19 but had learned of the gating means
through Mathews and that GE attorneys had advised that the gating means
be disclosed in Dewey's application to comply with  35 U.S.C. 112, first
paragraph. The examiner argued that the only way to overcome a  35
U.S.C. 102(e) rejection was by submitting an affidavit or declaration
under  37 CFR 1.131 to antedate the filing date of the reference. The
court reversed the rejection, holding that the totality of the evidence
on record showed that Dewey derived his knowledge from Mathews who is
"the original, first and sole inventor.").

---SECTION---2137 35 U.S.C. 102(f)

35 U.S.C. 102 Conditions for patentability; novelty and loss of right to
patent.

A person shall be entitled to a patent unless -

                  +++    

(f) he did not himself invent the subject matter sought to be patented.

                  +++    

Where it can be shown that an applicant "derived" an invention from
another, a rejection under  35 U.S.C. 102(f) is proper. Ex parte Kusko,
215 USPQ 972, 974 (Bd. App. 1981) ("most, if not all, determinations
under section 102(f) involve the question of whether one party derived
an invention from another").

While derivation will bar the issuance of a patent to the deriver, a
disclosure by the deriver, absent a bar under  35 U.S.C. 102(b), will
not bar the issuance of a patent to the party from which the subject
matter was derived. In re Costello, 717 F.2d 1346, 1349, 219 USPQ 389,
390-91 (Fed. Cir. 1983) ("[a] prior art reference that is not a
statutory bar may be overcome by two generally recognized methods": an
affidavit under  37 CFR 1.131, or an affidavit under  37 CFR 1.132
"showing that the relevant disclosure is a description of the
applicant's own work"); In re Facius, 408 F.2d 1396, 1407, 161 USPQ 294,
302 (CCPA 1969) (subject matter incorporated into a patent that was
brought to the attention of the patentee by applicant, and hence derived
by the patentee from the applicant, is available for use against
applicant unless applicant had actually invented the subject matter
placed in the patent).

Where there is a published article identifying the authorship (MPEP
Section  715.01(c)) or a patent identifying the inventorship (MPEP
Section  715.01(a)) that discloses subject matter being claimed in an
application undergoing examination, the designation of authorship or
inventorship does not raise a presumption of inventorship with respect
to the subject matter disclosed in the article or with respect to the
subject matter disclosed but not claimed in the patent so as to justify
a rejection under  35 U.S.C. 102(f). However, it is incumbent upon the
inventors named in the application, in reply to an inquiry regarding the
appropriate inventorship under subsection (f), or to rebut a rejection
under  35 U.S.C. 102(a) or (e), to provide a satisfactory showing by way
of affidavit under  37 CFR 1.132 that the inventorship of the
application is correct in that the reference discloses subject matter
invented by the applicant rather than derived from the author or
patentee notwithstanding the authorship of the article or the
inventorship of the patent. In re Katz, 687 F.2d 450, 455, 215 USPQ 14,
18 (CCPA 1982) (inquiry is appropriate to clarify any ambiguity created
by an article regarding inventorship, and it is then incumbent upon the
applicant to provide "a satisfactory showing that would lead to a
reasonable conclusion that [applicant] is the -- inventor" of the
subject matter disclosed in the article and claimed in the application).

DERIVATION REQUIRES COMPLETE CONCEPTION BY ANOTHER AND COMMUNICATION TO
THE ALLEGED DERIVER

"The mere fact that a claim recites the use of various components, each
of which can be argumentatively assumed to be old, does not provide a
proper basis for a rejection under  35 U.S.C. 102(f)." Ex parte
Billottet, 192 USPQ 413, 415 (Bd. App. 1976). Derivation requires
complete conception by another and communication of that conception by
any means to the party charged with derivation prior to any date on
which it can be shown that the one charged with derivation possessed
knowledge of the invention. Kilbey v. Thiele, 199 USPQ 290, 294 (Bd.
Pat. Inter. 1978).

See also Price v. Symsek, 988 F.2d 1187, 1190, 26 USPQ2d 1031, 1033
(Fed. Cir. 1993); Hedgewick v. Akers, 497 F.2d 905, 908, 182 USPQ 167,
169 (CCPA 1974).  "Communication of a complete conception must be
sufficient to enable one of ordinary skill in the art to construct and
successfully operate the invention." Hedgewick, 497 F.2d at 908, 182
USPQ at 169. See also Gambro Lundia AB v. Baxter Healthcare Corp., 110
F.3d 1573, 1577, 42 USPQ2d 1378, 1383 (Fed. Cir. 1997) (Issue in proving
derivation is "whether the communication enabled one of ordinary skill
in the art to make the patented invention.").

PARTY ALLEGING DERIVATION DOES NOT HAVE TO PROVE AN ACTUAL REDUCTION TO
PRACTICE, DERIVATION OF PUBLIC KNOWLEDGE, OR DERIVATION IN THIS COUNTRY

The party alleging derivation "need not prove an actual reduction to
practice in order to show derivation."   Scott v. Brandenburger, 216
USPQ 326, 327 (Bd. App. 1982). Furthermore, the application of
subsection (f) is not limited to public knowledge derived from another,
and "the site of derivation need not be in this country to bar a deriver
from patenting the subject matter." Ex parte Andresen, 212 USPQ 100, 102
(Bd. App. 1981).

DERIVATION DISTINGUISHED FROM PRIORITY OF INVENTION

Although derivation and priority of invention both focus on
inventorship, derivation addresses originality (i.e., who invented the
subject matter), whereas priority focuses on which party first invented
the subject matter. Price v. Symsek, 988 F.2d 1187, 1190, 26 USPQ2d
1031, 1033 (Fed. Cir. 1993).

 35 U.S.C. 102(f) MAY APPLY WHERE 35 U.S.C. 102(a) AND 35 U.S.C. 102(e)
ARE NOT AVAILABLE STATUTORY GROUNDS FOR REJECTION

35 U.S.C. 102(f) does not require an inquiry into the relative dates of
a reference and the application, and therefore may be applicable where
subsections (a) and (e) are not available for references having an
effective date subsequent to the effective date of the application being
examined. However for a reference having a date later than the date of
the application some evidence may exist that the subject matter of the
reference was derived from the applicant in view of the relative dates.
Ex parte Kusko, 215 USPQ 972, 974 (Bd. App. 1981) (The relative dates of
the events are important in determining derivation; a publication dated
more than a year after applicant's filing date that merely lists as
literary coauthors individuals other than applicant is not the strong
evidence needed to rebut a declaration by the applicant that he is the
sole inventor.).

---SECTION---2137.01 Inventorship 

The requirement that the applicant for a patent be the inventor is a
characteristic of U.S. patent law not generally shared by other
countries. Consequently, foreign applicants may misunderstand U.S. law
regarding naming of the actual inventors causing an error in the
inventorship of a U.S. application that may claim priority to a previous
foreign application under  35 U.S.C. 119. A petition under  37 CFR
1.48(a) is required to correct any error in naming the inventors in the
U.S. application as filed.  MPEP Section  201.03. Foreign applicants may
need to be reminded of the requirement for identity of inventorship
between a U.S. application and a  35 U.S.C. 119 priority application. 
MPEP Section  201.13.

If a determination is made that the inventive entity named in a U.S.
application is not correct, such as when a petition under  37 CFR
1.48(a) is not granted or is not entered for technical reasons, but the
admission therein regarding the error in inventorship is uncontroverted,
a rejection under  35 U.S.C. 102(f) should be made.

EXECUTORS OF OATH OR DECLARATION UNDER 37 CFR 1.63 ARE PRESUMED TO BE
THE INVENTORS

The party or parties executing an oath or declaration under  37 CFR 1.63
are presumed to be the inventors. Driscoll v. Cebalo, 5 USPQ2d 1477,
1481 (Bd. Pat. Inter. 1982); In re DeBaun, 687 F.2d 459, 463, 214 USPQ
933, 936 (CCPA 1982) (The inventor of an element, per se, and the
inventor of that element as used in a combination may differ. "The
existence of combination claims does not evidence inventorship by the
patentee of the individual elements or subcombinations thereof if the
latter are not separately claimed apart from the combination." (quoting
In re Facius, 408 F.2d 1396, 1406, 161 USPQ 294, 301 (CCPA 1969)
(emphasis in original)); Brader v. Schaeffer, 193 USPQ 627, 631 (Bd.
Pat. Inter. 1976) (in regard to an inventorship correction: "[a]s
between inventors their word is normally taken as to who are the actual
inventors" when there is no disagreement).

AN INVENTOR MUST CONTRIBUTE TO THE CONCEPTION OF THE INVENTION

The definition for inventorship can be simply stated: "The threshold
question in determining inventorship is who conceived the invention.
Unless a person contributes to the conception of the invention, he is
not an inventor.  --  Insofar as defining an inventor is concerned,
reduction to practice, per se, is irrelevant [except for simultaneous
conception and reduction to practice, Fiers v. Revel, 984 F.2d 1164,
1168, 25 USPQ2d 1601, 1604-05 (Fed. Cir. 1993)]. One must contribute to
the conception to be an inventor." In re Hardee, 223 USPQ 1122, 1123
(Comm'r Pat. 1984). See also Ex parte Smernoff, 215 USPQ 545, 547 (Bd.
App. 1982) ("one who suggests an idea of a result to be accomplished,
rather than the means of accomplishing it, is not an coinventor"). See
MPEP Section  2138.04 -  Section  2138.05 for a discussion of what
evidence is required to establish conception or reduction to practice.

AS LONG AS THE INVENTOR MAINTAINS INTELLECTUAL DOMINATION OVER MAKING
THE INVENTION, IDEAS, SUGGESTIONS, AND MATERIALS MAY BE ADOPTED FROM
OTHERS

"In arriving at  --  conception [the inventor] may consider and adopt
ideas and materials derived from many sources  --  [such as] a
suggestion from an employee, or hired consultant  --  so long as he
maintains intellectual domination of the work of making the invention
down to the successful testing, selecting or rejecting as he goes --
even if such suggestion [or material] proves to be the key that unlocks
his problem." Morse v. Porter, 155 USPQ 280, 283 (Bd. Pat. Inter. 1965).
See also New England Braiding Co. v. A.W. Chesterton Co., 970 F.2d 878,
883, 23 USPQ2d 1622, 1626 (Fed. Cir. 1992) (Adoption of the ideas and
materials from another can become a derivation.).

THE INVENTOR IS NOT REQUIRED TO REDUCE THE INVENTION TO PRACTICE

Difficulties arise in separating members of a team effort, where each
member of the team has contributed something, into those members that
actually contributed to the conception of the invention, such as the
physical structure or operative steps, from those members that merely
acted under the direction and supervision of the conceivers. Fritsch v.
Lin, 21 USPQ2d 1737, 1739 (Bd. Pat. App. & Inter. 1991) (The inventor
"took no part in developing the procedures -- for expressing the EPO
gene in mammalian host cells and isolating the resulting EPO product."
However, "it is not essential for the inventor to be personally involved
in carrying out process steps -- where implementation of those steps
does not require the exercise of inventive skill."); In re DeBaun, 687
F.2d 459, 463, 214 USPQ 933, 936 (CCPA 1982) ("there is no requirement
that the inventor be the one to reduce the invention to practice so long
as the reduction to practice was done on his behalf").

See also Mattor v. Coolegem, 530 F.2d 1391, 1395, 189 USPQ 201, 204
(CCPA 1976) (one following oral instructions is viewed as merely a
technician); Tucker v. Naito, 188 USPQ 260, 263 (Bd. Pat. Inter. 1975)
(inventors need not "personally construct and test their invention");
Davis v. Carrier,  81 F.2d 250, 252, 28 USPQ 227, 229 (CCPA 1936)
(noninventor's work was merely that of a skilled mechanic carrying out
the details of a plan devised by another).

REQUIREMENTS FOR JOINT INVENTORSHIP

The inventive entity for a particular application is based on some
contribution to at least one of the claims made by each of the named
inventors. "Inventors may apply for a patent jointly even though

(A) they did not physically work together or at the same time,

(B) each did not make the same type or amount of contribution, or

(C) each did not make a contribution to the subject matter of every
claim of the patent."  35 U.S.C.116. "[T]he statute neither states nor
implies that two inventors can be `joint inventors' if they have had no
contact whatsoever and are completely unaware of each other's work."
What is required is some "quantum of collaboration or connection." In
other words, "[f]or persons to be joint inventors under Section 116,
there must be some element of joint behavior, such as collaboration or
working under common direction, one inventor seeing a relevant report
and building upon it or hearing another's suggestion at a meeting."
Kimberly-Clark Corp. v. Procter & Gamble Distrib. Co., 973 F.2d 911,
916-17, 23 USPQ2d 1921, 1925-26 (Fed. Cir. 1992); Moler v. Purdy, 131
USPQ 276, 279 (Bd. Pat. Inter. 1960) ("it is not necessary that the
inventive concept come to both [joint inventors] at the same time").

INVENTORSHIP IS GENERALLY "TO ANOTHER" WHERE THERE ARE DIFFERENT
INVENTIVE ENTITIES WITH AT LEAST ONE INVENTOR IN COMMON

"[A] joint application or patent and a sole application or patent by one
of the joint inventors are [by] different legal entities and
accordingly, the issuance of the earlier filed application as a patent
becomes a reference for everything it discloses" (Ex parte Utschig, 156
USPQ 156, 157 (Bd. App. 1966)) except where:

(A) the claimed invention in a later filed application is entitled to
the benefit of an earlier filed application under  35 U.S.C. 120 (an
overlap of inventors rather than an identical inventive entity is
permissible). In this situation, a rejection under  35 U.S.C. 102(e) is
precluded. See Applied Materials Inc. v. Gemini Research Corp., 835 F.2d
279, 281, 15 USPQ2d 1816, 1818 (Fed. Cir. 1988) ("The fact that an
application has named a different inventive entity than a patent does
not necessarily make that patent prior art."); and

(B) the subject matter developed by another person and the claimed
subject matter were, at the time the invention was made, owned by the
same person or subject to an obligation of assignment to the same
person. In this situation, a rejection under  35 U.S.C. 102(f)/103 or
102(g)/103 is precluded by 35 U.S.C. 103(c).

For case law relating to inventorship by "another" involving different
inventive entities with at least one inventor in common see Ex parte
DesOrmeaux, 25 USPQ2d 2040 (Bd. Pat. App. & Inter. 1992) (the presence
of a common inventor in a reference patent and a pending application
does not preclude the determination that the reference inventive entity
is to "another" within the meaning of  35 U.S.C. 102(e)) and the
discussion of prior art available under  35 U.S.C. 102(e) in MPEP
Section  2136.04.

---SECTION---2137.02 Applicability of 35 U.S.C. 103(c)

35 U.S.C. 103(c) states that subsection (f) of  35 U.S.C. 102 will not
preclude patentability where subject matter developed by another person,
that would otherwise qualify under  35 U.S.C. 102(f), and the claimed
invention of an application under examination were owned by the same
person or subject to an obligation of assignment to the same person at
the time the invention was made. See MPEP Section  706.02(l) and Section 
2146.

---SECTION---2138 35 U.S.C. 102(g)

35 U.S.C. 102 Conditions for patentability; novelty and loss of right to
patent.

A person shall be entitled to a patent unless -

                  +++    

(g) before the applicant's invention thereof the invention was made in
this country by another who had not abandoned, suppressed, or concealed
it. In determining priority of invention there shall be considered not
only the respective dates of conception and reduction to practice of the
invention, but also the reasonable diligence of one who was first to
conceive and last to reduce to practice, from a time prior to conception
by the other.

35 U.S.C. 102(g) issues such as conception, reduction to practice and
diligence, while more commonly applied to interference matters, also
arise in other contexts. New Idea Farm Equip. Corp. v. Sperry Corp., 916
F.2d 1561, 1565, 16 USPQ2d 1424, 1428 (Fed. Cir. 1990). For example,  35
U.S.C. 102(g) and  35 U.S.C. 103 have been combined in the context of an
ex parte rejection entirely divorced from the award of priority in an
interference. In re Bass, 474 F.2d 1276, 1283, 177 USPQ 178, 183 (CCPA
1973) (in an unsuccessful attempt to utilize a  37 CFR 1.131 affidavit
relating to a combination application, applicants admitted that the
subcombination screen of a copending application which issued as a
patent was earlier conceived than the combination). See also E. I. Du
Pont de Nemours & Co. v. Phillips Petroleum Co., 849 F.2d 1430, 1433-34,
7 USPQ2d 1129, 1132 (Fed. Cir.), cert. denied, 488 U.S. 986 (1988)
(determining whether patent claims were novel under  35 U.S.C. 102(g) in
an infringement proceeding); In re Costello, 717 F.2d 1346, 219 USPQ 389
(Fed. Cir. 1983) (discussing the concepts of conception and constructive
reduction to practice in the context of a declaration under  37 CFR
1.131); Kawai v. Metlesics, 480 F.2d 880, 178 USPQ 158 (CCPA 1973)
(holding constructive reduction to practice for priority under  35
U.S.C. 119 requires meeting the requirements of  35 U.S.C. 101 and 35
U.S.C 112).

---SECTION---2138.01 Interference Practice

 35 U.S.C. 102(g) IS THE BASIS OF INTERFERENCE PRACTICE

Subsection (g) of  35 U.S.C. 102 is the basis of interference practice
for determining priority of invention between two parties. See   Bigham
v. Godtfredsen, 857 F.2d 1415, 1416, 8 USPQ2d 1266, 1267 (Fed. Cir.
1988),  35 U.S.C. 135,  37 CFR 1.601+ and MPEP chapter 2300. An
interference is an inter partes proceeding directed at determining the
first to invent as among the parties to the proceeding, involving two or
more pending applications naming different inventors or one or more
pending applications and one or more unexpired patents naming different
inventors (37 CFR 1.601(i)). The United States is unusual in having a
first to invent rather than a first to file system. Paulik v. Rizkalla,
760 F.2d 1270, 1272, 226 USPQ 224, 225 (Fed. Cir. 1985) (reviews the
legislative history of the subsection in a concurring opinion by Judge
Rich). The first of many to reduce an invention to practice around the
same time will be the sole party to obtain a patent, Radio Corp. of
America v. Radio Eng'g Labs., Inc., 293 U.S. 1,2, 21 USPQ 353, 353-4
(1934), unless another was the first to conceive and couple a
later-in-time reduction to practice with diligence from a time just
prior to when the second conceiver entered the field to the first
conceiver's reduction to practice. Hull v. Davenport, 90 F.2d 103, 105,
33 USPQ 506, 508 (CCPA 1937). See the priority time charts below
illustrating this point. Upon conclusion of an interference, subject
matter claimed by the losing party that was the basis of the
interference is rejected under  35 U.S.C. 102(g), unless the acts
showing prior invention were not in this country.

It is noted that  35 U.S.C. 101 requires that whoever invents or
discovers is the party who may obtain a patent for the particular
invention or discovery.  35 U.S.C. 111 (applicant) or  35 U.S.C. 116
(applicants) set forth the requirement that the actual inventor(s) be
the party who applies for a patent or that a patent be applied for on
behalf of the inventor. Where it can be shown that an applicant has
"derived" an invention from another, a rejection under  35 U.S.C. 102(f)
is proper. Ex parte Kusko, 215 USPQ 972, 974 (Bd. App. 1981) ("most, if
not all, determinations under Section 102(f) involve the question of
whether one party derived an invention from another"); Price v. Symsek,
988 F.2d 1187, 1190, 26 USPQ2d 1031, 1033 (Fed. Cir. 1993)(Although
derivation and priority of invention both focus on inventorship,
derivation addresses originality, i.e., who invented the subject matter,
whereas priority focuses on which party invented the subject matter
first.).

PRIORITY TIME CHARTS

The following priority time charts illustrate the award of invention
priority in several situations. The time charts apply to interference
proceedings and are also applicable to declarations or affidavits filed
under  37 CFR 1.131 to antedate references which are available as prior
art under  35 U.S.C. 102(a) or 102(e). Note, however, in the context of 
37 CFR 1.131, an applicant does not have to show that the invention was
not abandoned, suppressed, or concealed from the time of an actual
reduction to practice to a constructive reduction to practice because
the length of time taken to file a patent application after an actual
reduction to practice is generally of no consequence except in an
interference proceeding. Paulik v. Rizkalla, 760 F.2d 1270, 226 USPQ 224
(Fed. Cir. 1985). See the discussion of abandonment, suppression, and
concealment in MPEP Section  2138.03.

For purposes of analysis under  37 CFR 1.131, the conception and
reduction to practice of the reference to be antedated are both
considered to be on the effective filing date of domestic patent or
foreign patent or the date of printed publication.

In the charts, C = conception, R = reduction to practice (either actual
or constructive), Ra = actual reduction to practice, Rc = constructive
reduction to practice, and TD = commencement of diligence.

Example 1

[GRAPHIC]

A is awarded priority in an interference, or antedates B as a reference
in the context of a declaration or affidavit filed under  37 CFR 1.131,
because A conceived the invention before B and constructively reduced
the invention to practice before B reduced the invention to practice.
The same result would be reached if the conception date was the same for
both inventors A and B.

Example 2

[GRAPHIC]

A is awarded priority in an interference, or antedates B as a reference
in the context of a declaration or affidavit filed under  37 CFR 1.131,
if A can show reasonable diligence from TD (a point just prior to B's
conception) until Rc because A conceived the invention before B, and
diligently constructively reduced the invention to practice even though
this was after B reduced the invention to practice.

Example 3

[GRAPHIC]

A is awarded priority in an interference in the absence of abandonment,
suppression, or concealment from Ra to Rc, because A conceived the
invention before B, actually reduced the invention to practice before B
reduced the invention to practice, and did not abandon, suppress, or
conceal the invention after actually reducing the invention to practice
and before constructively reducing the invention to practice.

A antedates B as a reference in the context of a declaration or
affidavit filed under  37 CFR 1.131 because A conceived the invention
before B and actually reduced the invention to practice before B reduced
the invention to practice.

Example 4

[GRAPHIC]

A is awarded priority in an interference if A can show reasonable
diligence from TD (a point just prior to B's conception) until Ra in the
absence of abandonment, suppression, or concealment from Ra to Rc,
because A conceived the invention before B, diligently actually reduced
the invention to practice (after B reduced the invention to practice),
and did not abandon, suppress, or conceal the invention after actually
reducing the invention to practice and before constructively reducing
the invention to practice.

A antedates B as a reference in the context of a declaration or
affidavit filed under  37 CFR 1.131 because A conceived the invention
before B, and diligently actually reduced the invention to practice,
even though this was after B reduced the invention to practice.

 37 CFR 1.131 DOES NOT APPLY IN INTERFERENCE PROCEEDINGS

Interference practice operates to the exclusion of ex parte practice
under  37 CFR 1.131 which permits an applicant to show an actual date of
invention prior to the effective date of a patent or literature
reference applied under  35 U.S.C. 102(a) or (e), as long as the patent
is not a domestic patent claiming the same patentable invention. Ex
parte Standish, 10 USPQ2d 1454, 1457 (Bd. Pat. App. & Inter. 1988) (An
application claim to the "same patentable invention" claimed in a
domestic patent requires interference rather than an affidavit under  37
CFR 1.131 to antedate the patent. The term "same patentable invention"
encompasses a claim that is either anticipated by or obvious in view of
the subject matter recited in the patent claim.). Subject matter which
is available as prior art only under  35 U.S.C. 102(g) is by definition
made before the applicant made his invention and is therefore not open
to further inquiry under  37 CFR 1.131.

LOST COUNTS IN AN INTERFERENCE ARE NOT, PER SE, STATUTORY PRIOR ART

Loss of an interference count alone does not make its subject matter
statutory prior art to losing party; however, lost count subject matter
that is available as prior art under  35 U.S.C. 102 may be used alone or
in combination with other references under  35 U.S.C. 103. But see In re
Deckler, 977 F.2d 1449, 24 USPQ2d 1448 (Fed. Cir. 1992) (Under the
principles of res judicata and   collateral estoppel, Deckler was not
entitled to claims that were patentably indistinguishable from the claim
lost in interference even though the subject matter of the lost count
was not available for use in an obviousness rejection under  35 U.S.C.
103.).

---SECTION---2138.02 "The Invention Was Made in This Country"

An invention is made when there is a conception and a reduction to
practice. Dunn v. Ragin, 50 USPQ 472, 474 (Bd. Pat. Inter. 1941). Prior
art under  35 U.S.C. 102(g) is limited to an invention that is made. In
re Katz, 687 F.2d 450, 454, 215 USPQ 14, 17 (CCPA 1982) (the publication
of an article, alone, is not deemed a constructive reduction to
practice, and therefore its disclosure does not prove that any invention
within the meaning of  35 U.S.C. 102(g) has ever been made).

Subject matter under  35 U.S.C. 102(g) is available only if made in this
country.  35 U.S.C. 104. Kondo v. Martel, 220 USPQ 47 (Bd. Pat. Inter.
1983) (acts of conception, reduction to practice and diligence must be
demonstrated in this country). Compare Colbert v. Lofdahl, 21 USPQ2d
1068, 1071 (Bd. Pat. App. & Inter. 1991) ("[i]f the invention is reduced
to practice in a foreign country and knowledge of the invention was
brought into this country and disclosed to others, the inventor can
derive no benefit from the work done abroad and such knowledge is merely
evidence of conception of the invention").

Note, however, that  35 U.S.C. 104, as amended by GATT (Public Law
103-465, 108 Stat. 4809 (1994)) and NAFTA (Public Law 103-182, 107 Stat.
2057 (1993)), provides that an applicant can establish a date of
invention in a NAFTA member country on or after December 8, 1993 or in
WTO member country other than a NAFTA member country on or after January
1, 1996. Accordingly, an interference count may be won or lost on the
basis of establishment of invention by one of the parties in a NAFTA or
WTO member country, thereby rendering the subject matter of that count
unpatentable to the other party under the principles of res judicata and
collateral estoppel, even though such subject matter is not available as
statutory prior art under  35 U.S.C. 102(g). See MPEP Section  2138.01
regarding lost interference counts which are not statutory prior art.

---SECTION---2138.03 "By Another Who Has Not Abandoned, Suppressed, or
Concealed It"

35 U.S.C. 102(g) generally makes available as prior art within the
meaning of  35 U.S.C. 103, the prior invention of another who has not
abandoned, suppressed or concealed it. In re Bass, 474 F.2d 1276, 177
USPQ 178 (CCPA 1973);  In re Suska, 589 F.2d 527, 200 USPQ 497 (CCPA
1979) (The result of applying the suppression and concealment doctrine
is that the inventor who did not conceal (but was the de facto last
inventor) is treated legally as the first to invent, while the de facto
first inventor who suppressed or concealed is treated as a later
inventor. The de facto first inventor, by his suppression and
concealment, lost the right to rely on his actual date of invention not
only for priority purposes, but also for purposes of avoiding the
invention of the counts as prior art.).

"The courts have consistently held that an invention, though completed,
is deemed abandoned, suppressed, or concealed if, within a reasonable
time after completion, no steps are taken to make the invention publicly
known. Thus failure to file a patent application; to describe the
invention in a publicly disseminated document; or to use the invention
publicly, have been held to constitute abandonment, suppression, or
concealment." Correge v. Murphy, 705 F.2d 1326, 1330,   217 USPQ 753,
756 (Fed. Cir. 1983) (quoting International Glass Co. v. United States,
408 F.2d 395, 403, 159 USPQ 434, 441 (Ct. Cl. 1968)). In Correge, an
invention was actually reduced to practice, 7 months later there was a
public disclosure of the invention, and 8 months thereafter a patent
application was filed. The court held filing a patent application within
1 year of a public disclosure is not an unreasonable delay, therefore
reasonable diligence must only be shown between the date of the actual
reduction to practice and the public disclosure to avoid the inference
of abandonment.

DURING AN INTERFERENCE PROCEEDING, AN INFERENCE OF SUPPRESSION OR
CONCEALMENT MAY ARISE FROM DELAY IN FILING PATENT APPLICATION

Once an invention is actually reduced to practice an inventor need not
rush to file a patent application. Shindelar v. Holdeman, 628 F.2d 1337,
1341, 207 USPQ 112, 116 (CCPA 1980). The length of time taken to file a
patent application after an actual reduction to practice is generally of
no consequence except in an interference proceeding. Paulik v. Rizkalla,
760 F.2d 1270, 1271, 226 USPQ 225, 226 (Fed. Cir. 1985) (suppression or
concealment may be deliberate or may arise due to an inference from a
"too long" delay in filing a patent application). Peeler v. Miller, 535
F.2d 647, 656, 190 USPQ 117,124 (CCPA 1976) ("mere delay, without more,
is not sufficient to establish suppression or concealment." "What we are
deciding here is that Monsanto's delay is not `merely delay' and that
Monsanto's justification for the delay is inadequate to overcome the
inference of suppression created by the excessive delay." The word
"mere" does not imply a total absence of a limit on the duration of
delay. Whether any delay is "mere" is decided only on a case-by-case
basis.).

Where a junior party in an interference relies upon an actual reduction
to practice to demonstrate first inventorship, and where the hiatus in
time between the date for the junior party's asserted reduction to
practice and the filing of its application is unreasonably long, the
hiatus may give rise to an inference that the junior party in fact
suppressed or concealed the invention and the junior party will not be
allowed to rely upon the earlier actual reduction to practice. Young v.
Dworkin, 489 F.2d 1277, 1280 n.3, 180 USPQ 388, 391 n.3 (CCPA 1974)
(suppression and concealment issues are to be addressed on a
case-by-case basis).

SUPPRESSION OR CONCEALMENT NEED NOT BE ATTRIBUTED TO INVENTOR

Suppression or concealment need not be attributed to the inventor.
Peeler v. Miller, 535 F.2d 647, 653-54, 190 USPQ 117, 122 (CCPA 1976)
("four year delay from the time an inventor  --  completes his work  -- 
and the time his assignee-employer files a patent application is, prima
facie, unreasonably long in an interference with a party who filed
first");   Shindelar v. Holdeman, 628 F.2d 1337, 1341-42, 207 USPQ 112,
116-17 (CCPA 1980) (A patent attorney's workload will not preclude a
holding of an unreasonable delay-a total of 3 months was identified as
possible of excuse in regard to the filing of an application.).

INFERENCE OF SUPPRESSION OR CONCEALMENT IS REBUTTABLE

Notwithstanding a finding of suppression or concealment, a constructive
reduction to practice such as renewed activity just prior to other
party's entry into field coupled with the diligent filing of an
application would still cause the junior party to prevail. Lutzker v.
Plet, 843 F.2d 1364, 1367-69, 6 USPQ2d 1370, 1371-72 (Fed. Cir. 1988)
(activities directed towards commercialization not sufficient to rebut
inference); Holmwood v. Cherpeck, 2 USPQ2d 1942, 1945 (Bd. Pat. App. &
Inter. 1986) (the inference of suppression or concealment may be
rebutted by showing activity directed to perfecting the invention,
preparing the application, or preparing other compounds within the scope
of the generic invention); Engelhardt v. Judd, 369 F.2d 408, 411, 151
USPQ 732, 735 (CCPA 1966) ("We recognize that an inventor of a new
series of compounds should not be forced to file applications piecemeal
on each new member as it is synthesized, identified and tested for
utility. A reasonable amount of time should be allowed for completion of
the research project on the whole series of new compounds, and a further
reasonable time period should then be allowed for drafting and filing
the patent application(s) thereon."); Bogoslowsky v. Huse, 142 F.2d 75,
77, 61 USPQ 349, 351 (CCPA 1944) (The doctrine of suppression and
concealment is not applicable to conception without an actual reduction
to practice.).

ABANDONMENT

A finding of suppression or concealment may not amount to a finding of
abandonment wherein a right to a patent is lost. Steierman v. Connelly,
197 USPQ 288, 289 (Comm'r Pat. 1976); Correge v. Murphy, 705 F.2d 1326,
1329, 217 USPQ 753, 755 (Fed. Cir. 1983) (an invention cannot be
abandoned until it is first reduced to practice).

---SECTION---2138.04 "Conception"

Conception has been defined as "the complete performance of the mental
part of the inventive act" and it is "the formation in the mind of the
inventor of a definite and permanent idea of the complete and operative
invention as it is thereafter to be applied in practice -- ." Townsend
v. Smith, 36 F.2d 292, 295, 4 USPQ 269, 271 (CCPA 1930). "[C]onception
is established when the invention is made sufficiently clear to enable
one skilled in the art to reduce it to practice without the exercise of
extensive experimentation or the exercise of inventive skill." Hiatt v.
Ziegler, 179 USPQ 757, 763 (Bd. Pat. Inter. 1973). Conception has also
been defined as a disclosure of an invention which enables one skilled
in the art to reduce the invention to a practical form without "exercise
of the inventive faculty." Gunter v. Stream, 573 F.2d 77, 197 USPQ 482
(CCPA 1978). See also Coleman v. Dines, 754 F.2d 353, 224 USPQ 857 (Fed.
Cir. 1985) (It is settled that in establishing conception a party must
show possession of every feature recited in the count, and that every
limitation of the count must have been known to the inventor at the time
of the alleged conception. Conception must be proved by corroborating
evidence.); Hybritech Inc. v. Monoclonal Antibodies Inc., 802 F. 2d
1367, 1376, 231 USPQ 81, 87 (Fed. Cir. 1986) (Conception is the
"formation in the mind of the inventor, of a definite and permanent idea
of the complete and operative invention, as it is hereafter to be
applied in practice.").

CONCEPTION MUST BE DONE IN THE MIND OF THE INVENTOR

The inventor must form a definite and permanent idea of the complete and
operable invention to establish conception. Bosies v. Benedict, 27 F.3d
539, 543, 30 USPQ2d 1862, 1865 (Fed. Cir. 1994) (Testimony by a
noninventor as to the meaning of a variable of a generic compound
described in an inventor's notebook was insufficient as a matter of law
to establish the meaning of the variable because the testimony was not
probative of what the inventors conceived.).

AS LONG AS THE INVENTOR MAINTAINS INTELLECTUAL DOMINATION OVER MAKING
THE INVENTION, IDEAS, SUGGESTIONS, AND MATERIALS MAY BE ADOPTED FROM
OTHERS

An inventor may consider and adopt ideas, suggestions and materials
derived from many sources: a suggestion from an employee, a hired
consultant or a friend even if the adopted material proves to be the key
that unlocks the problem so long as the inventor "maintains intellectual
domination of the work of making the invention down to the successful
testing, selecting or rejecting -- ." Morse v. Porter, 155 USPQ 280, 283
(Bd. Pat. Inter. 1965); Staehelin v. Secher, 24 USPQ2d 1513, 1522 (Bd.
Pat. App. & Inter. 1992) ("evidence of conception naming only one of the
actual inventive entity inures to the benefit of and serves as evidence
of conception by the complete inventive entity").

CONCEPTION REQUIRES CONTEMPORANEOUS RECOGNITION AND APPRECIATION OF THE
INVENTION

There must be a contemporaneous recognition and appreciation of the
invention for there to be conception. Silvestri v. Grant, 496 F.2d 593,
596, 181 USPQ 706, 708 (CCPA 1974) ("an accidental and unappreciated
duplication of an invention does not defeat the patent right of one who,
though later in time was the first to recognize that which constitutes
the inventive subject matter"); Langer v. Kaufman, 465 F.2d  915, 918,
175 USPQ 172, 174 (CCPA 1972) (new form of catalyst was not recognized
when it was first produced; conception cannot be established nunc pro
tunc). However, an inventor does not need to know that the invention
will work for there to be complete conception. Burroughs Wellcome Co. v.
Barr Labs., Inc., 40 F.3d 1223, 1228, 32 USPQ2d 1915, 1919 (Fed. Cir.
1994) (Draft patent application disclosing treatment of AIDS with AZT
reciting dosages, forms, and routes of administration was sufficient to
collaborate conception whether or not the inventors believed the
inventions would work based on initial screening tests.).

While conception of a species within a genus may constitute conception
of the genus, conception of one species and the genus may not constitute
conception of another species in the genus. Oka v. Youssefyeh, 849 F.2d
581, 7 USPQ2d 1169 (Fed. Cir. 1988) (conception of a chemical requires
both the idea of the structure of the chemical and possession of an
operative method of making it). See also Amgen v. Chugai Pharmaceutical
Co., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (in the
isolation of a gene, defining a gene by its principal biological
property is not sufficient for conception absent an ability to envision
the detailed constitution as well as a method for obtaining it); Fiers
v. Revel, 984 F.2d 1164, 1170, 25 USPQ2d 1601, 1605 (Fed. Cir. 1993)
("[b]efore reduction to practice, conception only of a process for
making a substance, without conception of a structural or equivalent
definition of that substance, can at most constitute a conception of the
substance claimed as a process" but cannot constitute conception of the
substance; as "conception is not enablement," conception of a purified
DNA sequence coding for a specific protein by function and a method for
its isolation that could be carried out by one of ordinary skill in the
art is not conception of that material).

On rare occasions conception and reduction to practice occur
simultaneously. Alpert v. Slatin, 305 F.2d 891, 894, 134 USPQ 296, 299
(CCPA 1962). "[I]n some unpredictable areas of chemistry and biology,
there is no conception until the invention has been reduced to
practice." MacMillan v. Moffett, 432 F.2d 1237, 1234-40, 167 USPQ 550,
552-553 (CCPA 1970). See also Dunn v. Ragin, 50 USPQ 472, 475 (Bd. Pat.
Inter. 1941) (a new variety of asexually reproduced plant is conceived
and reduced to practice when it is grown and recognized as a new
variety). Under these circumstances, conception is not complete if
subsequent experimentation reveals factual uncertainty which "so
undermines the specificity of the inventor's idea that it is not yet a
definite and permanent reflection of the complete invention as it will
be used in practice." Burroughs Wellcome Co. v. Barr Labs., Inc., 40
F.3d 1223, 1229, 32 USPQ2d 1915, 1920 (Fed. Cir. 1994).

A PREVIOUSLY ABANDONED APPLICATION WHICH WAS NOT COPENDING WITH A
SUBSEQUENT APPLICATION IS EVIDENCE ONLY OF CONCEPTION

An abandoned application with which no subsequent application was
copending serves to abandon benefit of the application's filing as a
constructive reduction to practice and the abandoned application is
evidence only of conception. In re Costello, 717 F.2d 1346, 1350, 219
USPQ 389, 392 (Fed. Cir. 1983).

---SECTION---2138.05 "Reduction to Practice"

Reduction to practice may be an actual reduction or a constructive
reduction to practice, i.e., filing of a patent application. Dunn v.
Ragin, 50 USPQ 472, 474 (Bd. Pat. Inter. 1941) (asexually reproduced
plants require an actual reduction to practice). A reduction to practice
can be done by another on behalf of the inventor. De Solms v.
Schoenwald, 15 USPQ2d 1507, 1510 (Bd. Pat. App. & Inter. 1990). "While
the filing of the original application theoretically constituted a
constructive reduction to practice at the time, the subsequent
abandonment of that application also resulted in an abandonment of the
benefit of that filing as a constructive reduction to practice. The
filing of the original application is, however, evidence of conception
of the invention. In re Costello, 717 F.2d 1346, 1350, 219 USPQ 389, 392
(Fed. Cir. 1983).

CONSTRUCTIVE REDUCTION TO PRACTICE REQUIRES COMPLIANCE WITH 35 U.S.C.
112, FIRST PARAGRAPH

Proof of a constructive reduction to practice requires sufficient
disclosure under the "how to use" and "how to make" requirements of  35
U.S.C. 112, first paragraph. Kawai v. Metlesics, 480 F.2d 880, 886, 178
USPQ 158, 163 (CCPA 1973) (A constructive reduction to practice is not
proven unless the specification discloses a practical utility where one
would not be obvious. Prior art which disclosed an anticonvulsant
compound which differed from the claimed compound only in the absence of
a -CH2- group connecting two functional groups was not sufficient to
establish utility of the claimed compound because the compounds were not
so closely related that they could be presumed to have the same
utility.). See also Bigham v. Godtfredsen, 857 F.2d 1415, 1417, 8 USPQ2d
1266, 1268 (Fed. Cir. 1988) ("[t]he generic term halogen comprehends a
limited number of species, and ordinarily constitutes a sufficient
written description of the common halogen species," except where the
halogen species are patentably distinct).

The first conceiver may rely on earlier filed applications under  35
U.S.C. 120 (Ginos v. Nedelec, 220 USPQ 831, 833 (Bd. Pat. Inter. 1983))
provided the earlier application satisfies  35 U.S.C. 112, first
paragraph (Suh v. Hoefle, 23 USPQ2d 1321, 1325 (Bd. Pat. App. & Inter.
1992)).

REQUIREMENTS TO ESTABLISH ACTUAL REDUCTION TO PRACTICE

The same evidence sufficient for a constructive reduction to practice
may be insufficient to establish an actual reduction to practice, which
requires a showing of the invention in a physical or tangible form that
shows every element of the count. Wetmore v. Quick, 536 F.2d 937, 942,
190 USPQ 223, 227 (CCPA 1976). For an actual reduction to practice, the
invention must have been sufficiently tested to demonstrate that it will
work for its intended purpose, but it need not be in a commercially
satisfactory stage of development. If a device is so simple, and its
purpose and efficacy so obvious, construction alone is sufficient to
demonstrate workability. King Instrument Corp. v. Otari Corp., 767 F.2d
853, 860, 226 USPQ 402, 407 (Fed. Cir. 1985).

For additional cases pertaining to the requirements necessary to
establish actual reduction to practice see DSL Dynamic Sciences, Ltd. v.
Union Switch & Signal, Inc., 928 F.2d 1122, 1126, 18 USPQ2d 1152, 1155
(Fed. Cir. 1991) ("events occurring after an alleged actual reduction to
practice can call into question whether reduction to practice has in
fact occurred"); Corona v. Dovan, 273 U.S. 692, 1928 C.D. 252 (1928) ("A
process is reduced to practice when it is successfully performed. A
machine is reduced to practice when it is assembled, adjusted and used.
A manufacture [i.e., article of manufacture] is reduced to practice when
it is completely manufactured. A composition of matter is reduced to
practice when it is completely composed." 1928 C.D. at 262-263 (emphasis
added).); Fitzgerald v. Arbib, 268 F.2d 763, 765-66, 122 USPQ 530,
531-32 (CCPA 1959) ("the reduction to practice of a three-dimensional
design invention requires the production of an article embodying that
design" in "other than a mere drawing").

TESTING REQUIRED TO ESTABLISH AN ACTUAL REDUCTION TO PRACTICE

"The nature of testing which is required to establish a reduction to
practice depends on the particular facts of each case, especially the
nature of the invention." Gellert v. Wanberg, 495 F.2d 779, 783, 181
USPQ 648, 652 (CCPA 1974) ("an invention may be tested sufficiently  -- 
where less than all of the conditions of actual use are duplicated by
the tests"); Wells v. Fremont, 177 USPQ 22, 24-5 (Bd. Pat. Inter. 1972)
("even where tests are conducted under `bench' or laboratory conditions,
those conditions must `fully duplicate each and every condition of
actual use' or if they do not, then the evidence must establish a
relationship between the subject matter, the test condition and the
intended functional setting of the invention," but it is not required
that all the conditions of all actual uses be duplicated, such as rain,
snow, mud, dust and submersion in water).

REDUCTION TO PRACTICE REQUIRES RECOGNITION AND APPRECIATION OF THE
INVENTION

The invention must be recognized and appreciated for a reduction to
practice to occur. Alsenz v. Hargraves, 13 USPQ2d 1371, 1374 (Bd. Pat.
App. & Int. 1989) (a reduction to practice cannot be established nunc
pro tunc); Meitzner v. Corte, 537 F.2d 524, 528, 190 USPQ 407, 410 (CCPA
1976) (there can be no conception or reduction to practice of a new form
or of a process using such a new form of an otherwise old composition
where there has been no recognition or appreciation of the existence of
the new form);   Estee Lauder, Inc. v. L'Oreal S.A., 129 F.3d 588, 593,
44 USPQ2d 1610, 1615 (Fed. Cir. 1997) ("[W]hen testing is necessary to
establish utility, there must be recognition and appreciation that the
tests were successful for reduction to practice to occur."  A showing
that testing was completed before the critical date, and that testing
ultimately proved successful, was held insufficient to establish a
reduction to practice before the critical date, since the success of the
testing was not appreciated or recognized until after the critical
date.); Parker v. Frilette, 462 F.2d 544, 547, 174 USPQ 321, 324 (CCPA
1972) ("[an] inventor need not understand precisely why his invention
works in order to achieve an actual reduction to practice").

IN AN INTERFERENCE PROCEEDING, ALL LIMITATIONS OF A COUNT MUST BE
REDUCED TO PRACTICE

The device reduced to practice must include every limitation of the
count. Fredkin v. Irasek, 397 F.2d 342, 158 USPQ 280, 285 (CCPA 1968);
every limitation in a count is material and must be proved to establish
an actual reduction to practice.   Meitzner v. Corte, 537 F.2d 524, 528,
190 USPQ 407, 410. See also Hull v. Bonis, 214 USPQ 731, 734 (Bd. Pat.
Inter. 1982) (no doctrine of equivalents-remedy is a preliminary motion
to amend the count to conform to the proofs).

CLAIMED INVENTION IS NOT ACTUALLY REDUCED TO PRACTICE UNLESS THERE IS A
KNOWN UTILITY

Utility for the invention must be known at the time of the reduction to
practice. Wiesner v. Weigert, 666 F.2d 582, 588, 212 USPQ 721, 726 (CCPA
1981) (except for plant and design inventions); Azar v. Burns, 188 USPQ
601, 604 (Bd. Pat. Inter. 1975) (a composition and a method cannot be
actually reduced to practice unless the composition and the product
produced by the method have a practical utility);   Ciric v. Flanigen,
511 F.2d 1182, 1185, 185 USPQ 103, 105-6 (CCPA 1975) ("when a count does
not recite any particular utility, evidence establishing a substantial
utility for any purpose is sufficient to prove a reduction to practice";
"the demonstrated similarity of ion exchange and adsorptive properties
between the newly discovered zeolites and known crystalline zeolites  -- 
have established utility for the zeolites of the count"); Engelhardt v.
Judd, 369 F.2d 408, 411, 151 USPQ 732, 735 (CCPA 1966) (When considering
an actual reduction to practice as a bar to patentability for claims to
compounds, it is sufficient to successfully demonstrate utility of the
compounds in animals for somewhat different pharmaceutical purposes than
those asserted in the specification for humans.); Rey-Bellet v.
Engelhardt, 993 F.2d 1380, 1384, 181 USPQ 453, 455 (CCPA 1974) (Two
categories of tests on laboratory animals have been considered adequate
to show utility and reduction to practice: first, tests carried out to
prove utility in humans where there is a satisfactory correlation
between humans and animals, and second, tests carried out to prove
utility for treating animals.).

A PROBABLE UTILITY MAY NOT BE SUFFICIENT TO ESTABLISH UTILITY

A probable utility does not establish a practical utility, which is
established by actual testing or where the utility can be "foretold with
certainty." Bindra v. Kelly, 206 USPQ 570, 575 (Bd. Pat. Inter. 1979)
(Reduction to practice was not established for an intermediate useful in
the preparation of a second intermediate with a known utility in the
preparation of a pharmaceutical. The record established there was a high
degree of probability of a successful preparation because one skilled in
the art may have been motivated, in the sense of  35 U.S.C. 103, to
prepare the second intermediate from the first intermediate. However, a
strong probability of utility is not sufficient to establish practical
utility.); Wu v. Jucker, 167 USPQ 467, 472 (Bd. Pat. Inter. 1968)
(screening test where there was an indication of possible utility is
insufficient to establish practical utility). But see Nelson v. Bowler,
628 F.2d 853, 858, 206 USPQ 881, 885 (CCPA 1980) (Relevant evidence is
judged as a whole for its persuasiveness in linking observed properties
to suggested uses. Reasonable correlation between the two is sufficient
for an actual reduction to practice.).

---SECTION---2138.06 "Reasonable Diligence"

The diligence of  35 U.S.C. 102(g) relates to rea sonable
"attorney-diligence" and "engineering-diligence" (Keizer v. Bradley, 270
F.2d 396, 397, 123 USPQ 215, 216 (CCPA 1959)), which does not require
that "an inventor or his attorney  --  drop all other work and
concentrate on the particular invention involved -- ." Emery v. Ronden,
188 USPQ 264, 268 (Bd. Pat. Inter. 1974).

CRITICAL PERIOD FOR ESTABLISHING DILIGENCE BETWEEN ONE WHO WAS FIRST TO
CONCEIVE BUT LATER TO REDUCE TO PRACTICE THE INVENTION

The critical period for diligence for a first conceiver but second
reducer begins not at the time of conception of the first conceiver but
just prior to the entry in the field of the party who was first to
reduce to practice and continues until the first conceiver reduces to
practice. Hull v. Davenport, 90 F.2d 103, 105, 33 USPQ 506, 508 (CCPA
1937) ("lack of diligence from the time of conception to the time
immediately preceding the conception date of the second conceiver is not
regarded as of importance except as it may have a bearing upon his
subsequent acts"). What serves as the entry date into the field of a
first reducer is dependent upon what is being relied on by the first
reducer, e.g., conception plus reasonable diligence to reduction to
practice (Fritsch v. Lin, 21 USPQ2d 1731, 1734 (Bd. Pat. App. & Inter.
1991), Emery v. Ronden, 188 USPQ 264, 268 (Bd. Pat. Inter. 1974)); an
actual reduction to practice or a constructive reduction to practice by
the filing of either a U.S. application (Rebstock v. Flouret, 191 USPQ
342, 345 (Bd. Pat. Inter. 1975)) or reliance upon priority under  35
U.S.C. 119 of a foreign application (Justus v. Appenzeller, 177 USPQ
332, 339 (Bd. Pat. Inter. 1971) (chain of priorities under  35 U.S.C.
119 and 120, priority under  35 U.S.C. 119 denied for failure to supply
certified copy of the foreign application during pendency of the
application filed within the twelfth month)).

THE ENTIRE PERIOD DURING WHICH DILIGENCE IS REQUIRED MUST BE ACCOUNTED
FOR BY EITHER AFFIRMATIVE ACTS OR ACCEPTABLE EXCUSES

An applicant must account for the entire period during which diligence
is required. Gould v. Schawlow, 363 F.2d 908, 919, 150 USPQ 634, 643
(CCPA 1966) (Merely stating that there were no weeks or months that the
invention was not worked on is not enough.); In re Harry, 333 F.2d 920,
923, 142 USPQ 164, 166 (CCPA 1964) (statement that the subject matter
"was diligently reduced to practice" is not a showing but a mere
pleading). A 2-day period lacking activity has been held to be fatal. In
re Mulder, 716 F.2d 1542, 1545, 219 USPQ 189, 193  (Fed. Cir. 1983) (37
CFR 1.131 issue); Fitzgerald v. Arbib, 268 F.2d 763, 766, 122 USPQ 530,
532 (CCPA 1959) (Less than 1 month of inactivity during critical period.
Efforts to exploit an invention commercially do not constitute diligence
in reducing it to practice. An actual reduction to practice in the case
of a design for a three-dimensional article requires that it should be
embodied in some structure other than a mere drawing.); Kendall v.
Searles, 173 F.2d 986, 993, 81 USPQ 363, 369 (CCPA 1949) (Diligence
requires that applicants must be specific as to dates and facts.).

The period during which diligence is required must be accounted for by
either affirmative acts or acceptable excuses. Rebstock v. Flouret, 191
USPQ 342, 345 (Bd. Pat. Inter. 1975); Rieser v. Williams, 225 F.2d 419,
423, 118 USPQ 96, 100 (CCPA 1958) (Being last to reduce to practice,
party cannot prevail unless he has shown that he was first to conceive
and that he exercised reasonable diligence during the critical period
from just prior to opponent's entry into the field); Griffith v.
Kanamaru, 816 F.2d 624, 2 USPQ2d 1361 (Fed. Cir. 1987) (Court generally
reviewed cases on excuses for inactivity including vacation extended by
ill health and daily job demands, and held lack of university funding
and personnel are not acceptable excuses.); Litchfield v. Eigen, 535
F.2d 72, 190 USPQ 113 (CCPA 1976) (budgetary limits and availability of
animals for testing not sufficiently described); Morway v. Bondi, 203
F.2d 741, 749, 97 USPQ 318, 323 (CCPA 1953) (voluntarily laying aside
inventive concept in pursuit of other projects is generally not an
acceptable excuse although there may be circumstances creating
exceptions);   Anderson v. Crowther, 152 USPQ 504, 512 (Bd. Pat. Inter.
1965) (preparation of routine periodic reports covering all
accomplishments of the laboratory insufficient to show diligence); Wu v.
Jucker, 167 USPQ 467, 472-73 (Bd. Pat. Inter. 1968) (applicant
improperly allowed test data sheets to accumulate to a sufficient amount
to justify interfering with equipment then in use on another project);
Tucker v. Natta, 171 USPQ 494,498 (Bd. Pat. Inter. 1971) ("[a]ctivity
directed toward the reduction to practice of a genus does not establish,
prima facie, diligence toward the reduction to practice of a species
embraced by said genus"); Justus v. Appenzeller, 177 USPQ 332, 340-1
(Bd. Pat. Inter. 1971) (Although it is possible that patentee could have
reduced the invention to practice in a shorter time by relying on stock
items rather than by designing a particular piece of hardware, patentee
exercised reasonable diligence to secure the required hardware to
actually reduce the invention to practice. "[I]n deciding the question
of diligence it is immaterial that the inventor may not have taken the
expeditious course -- .").

WORK RELIED UPON TO SHOW REASONABLE DILIGENCE MUST BE DIRECTLY RELATED
TO THE REDUCTION TO PRACTICE

The work relied upon to show reasonable diligence must be directly
related to the reduction to practice of the invention in issue. Naber v.
Cricchi, 567 F.2d 382, 384, 196 USPQ 294, 296 (CCPA 1977), cert. denied,
439 U.S. 826 (1978). "[U]nder some circumstances an inventor should also
be able to rely on work on closely related inventions as support for
diligence toward the reduction to practice on an invention in issue."
Ginos v. Nedelec, 220 USPQ 831, 836 (Bd. Pat. Inter. 1983) (work on
other closely related compounds that were considered to be part of the
same invention and which were included as part of a grandparent
application). "The work relied upon must be directed to attaining a
reduction to practice of the subject matter of the counts. It is not
sufficient that the activity relied on concerns related subject matter."
Gunn v. Bosch, 181 USPQ 758, 761 (Bd. Pat. Inter. 1973) (An actual
reduction to practice of the invention at issue which occurred when the
inventor was working on a different invention "was fortuitous, and not
the result of a continuous intent or effort to reduce to practice the
invention here in issue. Such fortuitousness is inconsistent with the
exercise of diligence toward reduction to practice of that invention."
181 USPQ at 761. Furthermore, evidence drawn towards work on improvement
of samples or specimens generally already in use at the time of
conception that are but one element of the oscillator circuit of the
count does not show diligence towards the construction and testing of
the overall combination.); Broos v. Barton, 142 F.2d 690, 691, 61 USPQ
447, 448 (CCPA 1944) (preparation of application in U.S. for foreign
filing constitutes diligence); De Solms v. Schoenwald, 15 USPQ2d 1507
(Bd. Pat. App. & Inter. 1990) (principles of diligence must be given to
inventor's circumstances including skill and time; requirement of
corroboration applies only to testimony of inventor); Huelster v.
Reiter, 168 F.2d 542, 78 USPQ 82 (CCPA 1948) (if inventor was not able
to make an actual reduction to practice of the invention, he must also
show why he was not able to constructively reduce the invention to
practice by the filing of an application).

DILIGENCE REQUIRED IN PREPARING AND FILING PATENT APPLICATION

The diligence of attorney in preparing and filing patent application
inures to the benefit of the inventor. Conception was established at
least as early as the date a draft of a patent application was finished
by a patent attorney on behalf of the inventor. Conception is less a
matter of signature than it is one of disclosure. Attorney does not
prepare a patent application on behalf of particular named persons, but
on behalf of the true inventive entity. Six days to execute and file
application is acceptable. Haskell v. Coleburne, 671 F.2d 1362, 213 USPQ
192, 195 (CCPA 1982). See also   Bey v. Kollonitsch, 866 F.2d 1024, 231
USPQ 967 (Fed. Cir. 1986) (Reasonable diligence is all that is required
of the attorney. Reasonable diligence is established if attorney worked
reasonably hard on the application during the continuous critical
period. If the attorney has a reasonable backlog of unrelated cases
which he takes up in chronological order and carries out expeditiously,
that is sufficient. Work on a related case(s) that contributed
substantially to the ultimate preparation of an application can be
credited as diligence.).

END OF DILIGENCE PERIOD IS MARKED BY EITHER ACTUAL OR CONSTRUCTIVE
REDUCTION TO PRACTICE

"[I]t is of no moment that the end of that period [for diligence] is
fixed by a constructive, rather than an actual, reduction to practice."
Justus v. Appenzeller, 177 USPQ 332, 340-1 (Bd. Pat. Inter. 1971).

---SECTION---2141 35 U.S.C. 103; The Graham Factual Inquiries

35 U.S.C. 103 Conditions for patentability; non-obvious subject matter.

(a) A patent may not be obtained though the invention is not identically
disclosed or described as set forth in section 102 of this title, if the
differences between the subject matter sought to be patented and the
prior art are such that the subject matter as a whole would have been
obvious at the time the invention was made to a person having ordinary
skill in the art to which said subject matter pertains. Patentability
shall not be negatived by the manner in which the invention was made.

(b)(l) Notwithstanding subsection (a), and upon timely election by the
applicant for patent to proceed under this subsection, a
biotechnological process using or resulting in a composition of matter
that is novel under section 102 and nonobvious under subsection (a) of
this section shall be considered nonobvious if-

(A) claims to the process and the composition of matter are contained in
either the same application for patent or in separate applications
having the same effective filing date; and

(B) the composition of matter, and the process at the time it was
invented, were owned by the same person or subject to an obligation of
assignment to the same person.

(2) A patent issued on a process under paragraph (1)-

(A) shall also contain the claims to the composition of matter used in
or made by that process, or

(B) shall, if such composition of matter is claimed in another patent,
be set to expire on the same date as such other patent, notwithstanding
section 154.

(3) For purposes of paragraph (1), the term "biotechnological process"
means-

(A) a process of genetically altering or otherwise inducing a single- or
multi-celled organism to-

(i) express an exogenous nucleotide sequence,

(ii) inhibit, eliminate, augment, or alter expression of an endogenous
nucleotide sequence, or

(iii) express a specific physiological characteristic not naturally
associated with said organism;

(B) cell fusion procedures yielding a cell line that expresses a
specific protein, such as a monoclonal antibody; and

(C) a method of using a product produced by a process defined by
subparagraph (A) or (B), or a combination of subparagraphs (A) and (B).

(c) Subject matter developed by another person, which qualifies as prior
art only under subsection (f) or (g) of section 102 of this title, shall
not preclude patentability under this section where the subject matter
and the claimed invention were, at the time the invention was made,
owned by the same person or subject to an obligation of assignment to
the same person.

STANDARD OF PATENTABILITY TO BE APPLIED IN OBVIOUSNESS REJECTIONS

Patent examiners carry the responsibility of making sure that the
standard of patentability enunciated by the Supreme Court and by the
Congress is applied in each and every case. The Supreme Court in Graham
v. John Deere, 383 U.S. 1, 148 USPQ 459 (1966), stated:

Under Section  103, the scope and content of the prior art are to be
determined; differences between the prior art and the claims at issue
are to be ascertained; and the level of ordinary skill in the pertinent
art resolved. Against this background, the obviousness or nonobviousness
of the subject matter is determined. Such secondary considerations as
commercial success, long felt but unsolved needs, failure of others,
etc., might be utilized to give light to the circumstances surrounding
the origin of the subject matter sought to be patented. As indicia of
obviousness or nonobviousness, these inquires may have relevancy. . .

   This in not to say, however, that there will not be difficulties in
applying the nonobviousness test. What is obvious is not a question upon
which there is likely to be uniformity of thought in every given factual
context. The difficulties, however, are comparable to those encountered
daily by the courts in such frames of reference as negligence and
scienter, and should be amenable to a case-by-case development. We
believe that strict observance of the requirements laid down here will
result in that uniformity and definitiveness which Congress called for
in the 1952 Act.

Office policy has consistently been to follow   Graham v. John Deere Co.
in the consideration and determination of obviousness under  35 U.S.C.
103. As quoted above, the four factual inquires enunciated therein as a
background for determining obviousness are briefly as follows:

(A) Determining of the scope and contents of the prior art;

(B) Ascertaining the differences between the prior art and the claims in
issue;

(C) Resolving the level of ordinary skill in the pertinent art; and

(D) Evaluating evidence of secondary considerations.

The Supreme Court reaffirmed and relied upon the Graham three pronged
test in its consideration and determination of obviousness in the fact
situations presented in both the Sakraida v. Ag Pro, Inc., 425 U.S. 273,
189 USPQ 449, reh'g denied, 426 U.S. 955 (1976) and Anderson's-Black
Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 163 USPQ 673 (1969)
decisions. In each case, the Court went on to discuss whether the
claimed combinations produced a "new or different function"  and a
"synergistic result," but clearly decided whether the claimed inventions
were nonobviousness on the basis of the three-way test in Graham.
Nowhere in its decisions in those cases does the Court state that the
"new or different function" and "synergistic result" tests supersede a
finding of nonobvious or obviousness under the Graham test.

Accordingly, examiners should apply the test for patentability under  35
U.S.C. 103 set forth in Graham. See below for a detailed discussion of
each of the   Graham factual inquiries. It should be noted that the
Supreme Court's application of the Graham test to the fact circumstances
in Ag Pro was somewhat stringent, as it was in Black Rock. Note Republic
Industries, Inc. v. Schlage Lock Co., 592 F.2d 963, 200 USPQ 769 (7th
Cir. 1979). The Court of Appeals for the Federal Circuit stated in
Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1540,  218 USPQ 871,
880 (Fed. Cir. 1983) that

A requirement for "synergism" or a "synergistic effect" is nowhere found
in the statute, 35 U.S.C. When present, for example in a chemical case,
synergism may point toward nonobviousness, but its absence has no place
in evaluating the evidence on obviousness. The more objective findings
suggested in Graham, supra, are drawn from the language of the statute
and are fully adequate guides for evaluating the evidence relating to
compliance with 35 U.S.C. Section  103. Bowser Inc. v. United States,
388 F. 2d 346, 156 USPQ 406 (Ct. Cl. 1967).

BASIC CONSIDERATIONS WHICH APPLY TO OBVIOUSNESS REJECTIONS

When applying  35 U.S.C. 103, the following tenets of patent law must be
adhered to:

(A) The claimed invention must be considered as a whole;

(B) The references must be considered as a whole and must suggest the
desirability and thus the obviousness of making the combination;

(C) The references must be viewed without the benefit of impermissible
hindsight vision afforded by the claimed invention and

(D) Reasonable expectation of success is the standard with which
obviousness is determined. 

Hodosh v. Block Drug Co., Inc., 786 F.2d 1136, 1143 n.5, 229 USPQ 182,
187 n.5 (Fed. Cir. 1986).

OBJECTIVE EVIDENCE MUST BE CONSIDERED

Objective evidence or secondary considerations such as unexpected
results, commercial success, long-felt need, failure of others, copying
by others, licensing, and skepticism of experts are relevant to the
issue of obviousness and must be considered in every case in which they
are present. When evidence of any of these secondary considerations is
submitted, the examiner must evaluate the evidence. The weight to be
accorded to the evidence depends on the individual factual circumstances
of each case. Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 218
USPQ 871 (Fed. Cir. 1983);   Hybritech, Inc. v. Monoclonal Antibodies,
Inc., 802 F.2d 1367, 231 USPQ 81 (Fed. Cir. 1986), cert. denied, 480
U.S. 947 (1987). The ultimate determination on patentability is made on
the entire record. In re Oetiker, 977 F.2d 1443, 1446, 24 USPQ2d 1443,
1445 (Fed. Cir. 1992).

See MPEP Section  716-  Section  716.06 for a discussion of objective
evidence and its role in the final legal determination of whether a
claimed invention would have been obvious under  35 U.S.C. 103.

---SECTION---2141.01 Scope and Content of the Prior Art

I. PRIOR ART AVAILABLE UNDER 35 U.S.C. 102 IS AVAILABLE UNDER 35 U.S.C.
103

"Before answering Graham's `content' inquiry, it must be known whether a
patent or publication is in the prior art under 35 U.S.C. Section  102."
Panduit Corp. v. Dennison Mfg. Co., 810 F.2d 1561, 1568, 1 USPQ2d 1593,
1597 (Fed. Cir.), cert. denied, 481 U.S. 1052 (1987). Subject matter
that is prior art under  35 U.S.C. 102 can be used to support a
rejection under section 103. Ex parte Andresen, 212 USPQ 100, 102 (Bd.
Pat. App. & Inter. 1981) ("it appears to us that the commentator [of 35
U.S.C.A.] and the [congressional] committee viewed section 103 as
including all of the various bars to a patent as set forth in section
102.").

A  35 U.S.C. 103 rejection is based on  35 U.S.C. 102(a), 102(b),
102(e), etc. depending on the type of prior art reference used and its
publication or issue date. For instance, an obviousness rejection over a
U.S. patent which was issued more than 1 year before the filing is said
to be a statutory bar just as if it anticipated the claims under 102(b).
Analogously, an obviousness rejection based on a publication which would
be applied under 102(a) if it anticipated the claims can be overcome by
swearing behind the publication date of the reference by filing an
affidavit or declaration under  37 CFR 1.131.

For an overview of what constitutes prior art under  35 U.S.C. 102 see
MPEP Section  901 -  Section  901.06(d) and Section  2121 -  Section 
2129.

II. SUBSTANTIVE CONTENT OF THE PRIOR ART

See MPEP Section  2121 -  Section  2129 for case law relating to the
substantive content of the prior art (e.g., availability of inoperative
devices, extent to which prior art must be enabling, broad disclosure
rather than preferred embodiments, admissions, etc.).

III. CONTENT OF THE PRIOR ART IS DETERMINED AT THE TIME THE INVENTION
WAS MADE TO AVOID HINDSIGHT

Requirement for "at the time the invention was made" is to avoid
impermissible hindsight. See MPEP Section  2145, paragraph X.A. for a
discussion of rebutting applicants' arguments that a rejection is based
on hindsight.

"It is difficult but necessary that the decisionmaker forget what he or
she has been taught . . . about the claimed invention and cast the mind
back to the time the invention was made (often as here many years), to
occupy the mind of one skilled in the art who is presented only with the
references, and who is normally guided by the then-accepted wisdom in
the art." W.L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540,
220 USPQ 303, 313 (Fed. Cir. 1983), cert. denied, 469 U.S. 851 (1984).

IV. 35 U.S.C. 103(c) - EVIDENCE REQUIRED TO SHOW CONDITIONS OF 35 U.S.C.
103 APPLY

An applicant who wants to avail himself or herself of the benefits of 
35 U.S.C. 103(c) has the burden of establishing that subject matter
which qualifies as prior art under subsection (f) or (g) of section 102
and the claimed invention were, at the time the invention was made,
owned by the same person or subject to an obligation of assignment to
the same person. Ex parte Yoshino, 227 USPQ 52 (Bd. Pat. App. & Inter.
1985). Note that  35 U.S.C. 103(c) is limited on its face to subject
matter developed by another person which qualifies as prior art only
under subsection (f) or (g) of section 102. In re Bartfeld, 925 F.2d
1450, 1453-54, 17 USPQ2d 1885, 1888 (Fed. Cir. 1991) (Applicant
attempted to overcome a  35 U.S.C. 102(e)/103 rejection with a terminal
disclaimer by alleging that the public policy intent of 35 U.S.C 103(c)
was to prohibit the use of "secret" prior art in obviousness
determinations. The court rejected this argument, holding "We may not
disregard the unambiguous exclusion of Section  102(e) from the
statute's purview.").

See MPEP Section  706.02(l) for the requirements which must be met to
establish common ownership.

---SECTION---2141.01(a) Analogous and Nonanalogous Art

TO RELY ON A REFERENCE UNDER 35 U.S.C. 103, IT MUST BE ANALOGOUS PRIOR
ART

The examiner must determine what is "analogous prior art" for the
purpose of analyzing the obviousness of the subject matter at issue. "In
order to rely on a reference as a basis for rejection of an applicant's
invention, the reference must either be in the field of applicant's
endeavor or, if not, then be reasonably pertinent to the particular
problem with which the inventor was concerned." In re Oetiker, 977 F.2d
1443, 1446, 24 USPQ2d 1443, 1445 (Fed. Cir. 1992). See also In re
Deminski, 796 F.2d 436, 230 USPQ 313 (Fed. Cir. 1986); In re Clay, 966
F.2d 656, 659, 23 USPQ2d 1058, 1060-61 (Fed. Cir. 1992) ("A reference is
reasonably pertinent if, even though it may be in a different field from
that of the inventor's endeavor, it is one which, because of the matter
with which it deals, logically would have commended itself to an
inventor's attention in considering his problem."); and Wang
Laboratories Inc. v. Toshiba Corp., 993 F.2d 858, 26 USPQ2d 1767 (Fed.
Cir. 1993).

PTO CLASSIFICATION IS SOME EVIDENCE OF ANALOGY, BUT SIMILARITIES AND
DIFFERENCES IN STRUCTURE AND FUNCTION CARRY MORE WEIGHT

While Patent Office classification of references and the
cross-references in the official search notes are some evidence of
"nonanalogy" or "analogy" respectively, the court has found "the
similarities and differences in structure and function of the inventions
to carry far greater weight." In re Ellis, 476 F.2d 1370, 1372, 177 USPQ
526, 527 (CCPA 1973) (The structural similarities and functional overlap
between the structural gratings shown by one reference and the shoe
scrapers of the type shown by another reference were readily apparent,
and therefore the arts to which the reference patents belonged were
reasonably pertinent to the art with which appellant's invention dealt
(pedestrian floor gratings).); In re Clay, 966 F.2d 656, 23 USPQ2d 1058
(Fed. Cir. 1992) (Claims were directed to a process for storing a
refined liquid hydrocarbon product in a storage tank having a dead
volume between the tank bottom and its outlet port wherein a gelled
solution filled the tank's dead volume to prevent loss of stored product
while preventing contamination. One of the references relied upon
disclosed a process for reducing the permeability of natural underground
hydrocarbon bearing formations using a gel similar to that of applicant
to improve oil production. The court disagreed with the PTO's argument
that the reference and claimed inventions were part of the same
endeavor, "maximizing withdrawal of petroleum stored in petroleum
reserves," and found that the inventions involved different fields of
endeavor since the reference taught the use of the gel in a different
structure for a different purpose under different temperature and
pressure conditions, and since the application related to storage of
liquid hydrocarbons rather than extraction of crude petroleum. The court
also found the reference was not reasonably pertinent to the problem
with which the inventor was concerned because a person having ordinary
skill in the art would not reasonably have expected to solve the problem
of dead volume in tanks for refined petroleum by considering a reference
dealing with plugging underground formation anomalies.).

ANALOGY IN THE CHEMICAL ARTS

See, for example, Ex parte Bland, 3 USPQ2d 1103 (Bd. Pat App. & Inter.
1986) (Claims were drawn to a particulate composition useful as a
preservative for an animal foodstuff (or a method of inhibiting fungus
growth in an animal foodstuff therewith) comprising verxite having
absorbed thereon propionic acid. All references were concerned with
absorbing biologically active materials on carriers, and therefore the
teachings in each of the various references would have been pertinent to
the problems in the other references and the invention at hand.);
Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 218 USPQ 871 (Fed.
Cir. 1983) (Problem confronting inventor was preventing electrostatic
buildup in PTFE tubing caused by hydrocarbon fuel flow while precluding
leakage of fuel. Two prior art references relied upon were in the rubber
hose art, both referencing the problem of electrostatic buildup caused
by fuel flow. The court found that because PTFE and rubber are used by
the same hose manufacturers and experience the same and similar
problems, a solution found for a problem experienced with either PTFE or
rubber hosing would be looked to when facing a problem with the other.);
In re Mlot-Fijalkowski, 676 F.2d 666, 213 USPQ 713 (CCPA 1982) (Problem
faced by appellant was enhancement and immobilization of dye penetrant
indications. References which taught the use of dyes and finely divided
developer materials to produce colored images preferably in, but not
limited to, the duplicating paper art were properly relied upon because
the court found that appellant's problem was one of dye chemistry, and a
search for its solution would include the dye arts in general.).

ANALOGY IN THE MECHANICAL ARTS

See, for example, In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed.
Cir. 1992) (Applicant claimed an improvement in a hose clamp which
differed from the prior art in the presence of a preassembly "hook"
which maintained the preassembly condition of the clamp and disengaged
automatically when the clamp was tightened. The Board relied upon a
reference which disclosed a hook and eye fastener for use in garments,
reasoning that all hooking problems are analogous. The court held the
reference was not within the field of applicant's endeavor, and was not
reasonably pertinent to the particular problem with which the inventor
was concerned because it had not been shown that a person of ordinary
skill, seeking to solve a problem of fastening a hose clamp, would
reasonably be expected or motivated to look to fasteners for garments.
The Commissioner further argued in the brief on appeal that a
disengageable catch is a common everyday mechanical concept, however the
court held that the Commissioner did not explain why a "catch" of
unstated structure is such a concept, and why it would have made the
claimed invention obvious.). Compare Stevenson v. International Trade
Comm., 612 F.2d 546, 550, 204 USPQ 276, 280 (CCPA 1979) ("In a simple
mechanical invention a broad spectrum of prior art must be explored and
it is reasonable to permit inquiry into other areas where one of
ordinary skill in the art would be aware that similar problems exist.").

Also see   In re Deminski, 796 F.2d 436, 230 USPQ 313 (Fed. Cir. 1986)
(Applicant's claims related to double-acting high pressure gas
transmission line compressors in which the valves could be removed
easily for replacement. The Board relied upon references which taught
either a double-acting piston pump or a double-acting piston compressor.
The court agreed that since the cited pumps and compressors have
essentially the same function and structure, the field of endeavor
includes both types of double-action piston devices for moving fluids.);
Pentec, Inc. v. Graphic Controls Corp., 776 F.2d 309, 227 USPQ 766 (Fed.
Cir. 1985) (Claims at issue were directed to an instrument marker pen
body, the improvement comprising a pen arm holding means having an
integrally molded hinged member for folding over against the pen body.
Although the patent owners argued the hinge and fastener art was
nonanalogous, the court held that the problem confronting the inventor
was the need for a simple holding means to enable frequent, secure
attachment and easy removal of a marker pen to and from a pen arm, and
one skilled in the pen art trying to solve that problem would have
looked to the fastener and hinge art.); and Ex parte Goodyear Tire &
Rubber Co., 230 USPQ 357 (Bd. Pat. App. & Inter. 1985) (A reference in
the clutch art was held reasonably pertinent to the friction problem
faced by applicant, whose claims were directed to a braking material,
because brakes and clutches utilize interfacing materials to accomplish
their respective purposes.).

ANALOGY IN THE ELECTRICAL ARTS

See, for example, Wang Laboratories, Inc. v. Toshiba Corp., 993 F.2d
858, 26 USPQ2d 1767 (Fed. Cir. 1993) (Patent claims were directed to
single in-line memory modules (SIMMs) for installation on a printed
circuit motherboard for use in personal computers. Reference to a SIMM
for an industrial controller was not necessarily in the same field of
endeavor as the claimed subject matter merely because it related to
memories. Reference was found to be in a different field of endeavor
because it involved memory circuits in which modules of varying sizes
may be added or replaced, whereas the claimed invention involved compact
modular memories. Furthermore, since memory modules of the claims at
issue were intended for personal computers and used dynamic
random-access-memories, whereas reference SIMM was developed for use in
large industrial machine controllers and only taught the use of static
random- access-memories or read-only-memories, the finding that the
reference was nonanalogous was supported by substantial evidence.);
Medtronic, Inc. v. Cardiac Pacemakers, 721 F.2d 1563, 220 USPQ 97 (Fed.
Cir. 1983) (Patent claims were drawn to a cardiac pacemaker which
comprised, among other components, a runaway inhibitor means for
preventing a pacemaker malfunction from causing pulses to be applied at
too high a frequency rate. Two references disclosed circuits used in
high power, high frequency devices which inhibited the runaway of pulses
from a pulse source. The court held that one of ordinary skill in the
pacemaker designer art faced with a rate-limiting problem would look to
the solutions of others faced with rate limiting problems, and therefore
the references were in an analogous art.).

EXAMPLES OF ANALOGY IN THE DESIGN ARTS

See MPEP Section  1504.03 for a discussion of the relevant case law
setting forth the general requirements for analogous art in design
applications.

For examples of analogy in the design arts, see In re Rosen, 673 F.2d
388, 213 USPQ 347 (CCPA 1982) (The design at issue was a coffee table of
contemporary styling. The court held designs of contemporary furniture
other than coffee tables, such as the desk and circular glass table top
designs of the references relied upon, would reasonably fall within the
scope of the knowledge of the designer of ordinary skill.); Ex parte
Pappas, 23 USPQ2d 1636 (Bd. Pat. App. & Inter. 1992) (At issue was an
ornamental design for a feed bunk with an inclined corner configuration.
Examiner relied upon references to a bunk lacking the inclined corners
claimed by appellant and the Architectural Precast Concrete Drafting
Handbook. The Board found the Architectural Precast Concrete Drafting
Handbook was analogous art, noting that a bunk may be a wood or concrete
trough, and that both references relied upon "disclose structures in
which at least one upstanding leg is generally perpendicular to a base
portion to define a corner configuration between the leg and base
portion."); In re Butera, 1 F.3d 1252, 28 USPQ2d 1399 (Fed. Cir. 1993)
(unpublished - not citable as precedent) (The claimed invention, a
spherical design for a combined insect repellant and air freshener, was
rejected by the Board as obvious over a single reference to a design for
a metal ball anode. The court reversed, holding the reference design to
be nonanalogous art. "A prior design is of the type claimed if it has
the same general use as that claimed in the design patent application .
. . . One designing a combined insect repellant and air freshener would
therefore not have reason to know of or look to a design for a metal
ball anode." 28 USPQ2d at 1400.).

---SECTION---2141.02 Differences Between Prior Art and Claimed Invention

Ascertaining the differences between the prior art and the claims at
issue requires interpreting the claim language, and considering both the
invention and the prior art references as a whole. See MPEP Section 
2111 -  Section  2116.01 for case law pertaining to claim
interpretation.

THE CLAIMED INVENTION AS A WHOLE MUST BE CONSIDERED

In determining the differences between the prior art and the claims, the
question under  35 U.S.C. 103 is not whether the differences themselves
would have been obvious, but whether the claimed invention as a whole
would have been obvious. Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d
1530, 218 USPQ 871 (Fed. Cir. 1983); Schenck v. Nortron Corp., 713 F.2d
782, 218 USPQ 698 (Fed. Cir. 1983) (Claims were directed to a vibratory
testing machine (a hard-bearing wheel balancer) comprising a holding
structure, a base structure, and a supporting means which form "a single
integral and gaplessly continuous piece." Nortron argued the invention
is just making integral what had been made in four bolted pieces,
improperly limiting the focus to a structural difference from the prior
art and failing to consider the invention as a whole. The prior art
perceived a need for mechanisms to dampen resonance, whereas the
inventor eliminated the need for dampening via the one-piece gapless
support structure. "Because that insight was contrary to the
understandings and expectations of the art, the structure effectuating
it would not have been obvious to those skilled in the art." 713 F.2d at
785, 218 USPQ at 700 (citations omitted).).

See also In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) (Claims were
directed to a three step process for preparing sweetened foods and
drinks. The first two steps were directed to a process of producing high
purity maltose (the sweetener), and the third was directed to adding the
maltose to foods and drinks. The parties agreed that the first two steps
were unobvious but formed a known product and the third step was
obvious. The Solicitor argued the preamble was directed to a process for
preparing foods and drinks sweetened mildly and thus the specific method
of making the high purity maltose (the first two steps in the claimed
process) should not be given weight, analogizing with product-by-process
claims. The court held "due to the admitted unobviousness of the first
two steps of the claimed combination of steps, the subject matter as a
whole would not have been obvious to one of ordinary skill in the art at
the time the invention was made." 535 F.2d at 69, 190 USPQ at 17
(emphasis in original). The preamble only recited the purpose of the
process and did not limit the body of the claim. Therefore, the claimed
process was a three step process, not the product formed by two steps of
the process or the third step of using that product.).

DISTILLING THE INVENTION DOWN TO A "GIST" OR "THRUST" OF AN INVENTION
DISREGARDS "AS A WHOLE" REQUIREMENT

Distilling an invention down to the "gist" or "thrust" of an invention
disregards the requirement of analyzing the subject matter "as a whole."
W.L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ
303 (Fed. Cir. 1983), cert. denied, 469 U.S. 851 (1984) (restricting
consideration of the claims to a 10% per second rate of stretching of
unsintered PTFE and disregarding other limitations resulted in treating
claims as though they read differently than allowed); Bausch & Lomb v.
Barnes-Hind/Hydrocurve, Inc., 796 F.2d 443, 447-49, 230 USPQ 416, 419-20
(Fed. Cir. 1986), cert. denied, 484 U.S. 823 (1987) (District court
focused on the "concept of forming ridgeless depressions having smooth
rounded edges using a laser beam to vaporize the material," but
"disregarded express limitations that the product be an ophthalmic lens
formed of a transparent cross-linked polymer and that the laser marks be
surrounded by a smooth surface of unsublimated polymer."). See also
Jones v. Hardy, 727 F.2d 1524, 1530, 220 USPQ 1021, 1026 (Fed. Cir.
1984) ("treating the advantage as the invention disregards statutory
requirement that the invention be viewed `as a whole' "); Panduit Corp.
v. Dennison Mfg. Co., 810 F.2d 1561, 1 USPQ2d 1593 (Fed. Cir.), cert.
denied, 481 U.S. 1052 (1987) (district court improperly distilled claims
down to a one word solution to a problem).

DISCOVERING SOURCE/CAUSE OF A PROBLEM IS PART OF "AS A WHOLE" INQUIRY

"[A] patentable invention may lie in the discovery of the source of a
problem even though the remedy may be obvious once the source of the
problem is identified. This is part of the `subject matter as a whole'
which should always be considered in determining the obviousness of an
invention under 35 U.S.C. Section  103." In re Sponnoble, 405 F.2d 578,
585, 160 USPQ 237, 243 (CCPA 1969). However, "discovery of the cause of
a problem . . does not always result in a patentable invention. . . .
[A] different situation exists where the solution is obvious from prior
art which contains the same solution for a similar problem." In re
Wiseman, 596 F.2d 1019, 1022, 201 USPQ 658, 661 (CCPA 1979) (emphasis in
original).

In In re Sponnoble, the claim was directed to a plural compartment
mixing vial wherein a center seal plug was placed between two
compartments for temporarily isolating a liquid-containing compartment
from a solids-containing compartment. The claim differed from the prior
art in the selection of butyl rubber with a silicone coating as the plug
material instead of natural rubber. The prior art recognized that
leakage from the liquid to the solids compartment was a problem, and
considered the problem to be a result of moisture passing around the
center plug because of microscopic fissures inherently present in molded
or blown glass. The court found the inventor discovered the cause of
moisture transmission was through the center plug, and there was no
teaching in the prior art which would suggest the necessity of selecting
applicant's plug material which was more impervious to liquids than the
natural rubber plug of the prior art.

In In re Wiseman, 596 F.2d at 1022, 201 USPQ at 661, claims directed to
grooved carbon disc brakes wherein the grooves were provided to vent
steam or vapor during a braking action to minimize fading of the brakes
were rejected as obvious over a reference showing carbon disc brakes
without grooves in combination with a reference showing grooves in
noncarbon disc brakes for the purpose of cooling the faces of the
braking members and eliminating dust, thereby reducing fading of the
brakes. The court affirmed the rejection, holding that even if
applicants discovered the cause of a problem, the solution would have
been obvious from the prior art which contained the same solution
(inserting grooves in disc brakes) for a similar problem.

APPLICANTS ALLEGING DISCOVERY OF A SOURCE OF A PROBLEM MUST PROVIDE
SUBSTANTIATING EVIDENCE

Applicants who allege they discovered the source of a problem must
provide evidence substantiating the allegation, either by way of
affidavits or declarations, or by way of a clear and persuasive
assertion in the specification. In re Wiseman, 596 F.2d 1019, 201 USPQ
658 (CCPA 1979) (unsubstantiated statement of counsel was insufficient
to show appellants discovered source of the problem); In re Kaslow, 707
F.2d 1366, 217 USPQ 1089 (Fed. Cir. 1983) (Claims were directed to a
method for redeeming merchandising coupons which contain a UPC "5-by-5"
bar code wherein, among other steps, the memory at each supermarket
would identify coupons by manufacturer and transmit the data to a
central computer to provide an audit thereby eliminating the need for
clearinghouses and preventing retailer fraud. In challenging the
propriety of an obviousness rejection, appellant argued he discovered
the source of a problem (retailer fraud and manual clearinghouse
operations) and its solution. The court found appellant's specification
did not support the argument that he discovered the source of the
problem with respect to retailer fraud, and that the claimed invention
failed to solve the problem of manual clearinghouse operations.).

DISCLOSED INHERENT PROPERTIES ARE PART OF "AS A WHOLE" INQUIRY

"In determining whether the invention as a whole would have been obvious
under  35 U.S.C. 103, we must first delineate the invention as a whole.
In delineating the invention as a whole, we look not only to the subject
matter which is literally recited in the claim in question... but also
to those properties of the subject matter which are inherent in the
subject matter and are disclosed in the specification. . . Just as we
look to a chemical and its properties when we examine the obviousness of
a composition of matter claim, it is this invention   as a whole, and
not some part of it, which must be obvious under  35 USC 103." In re
Antonie, 559 F.2d 618, 620, 195 USPQ 6,8 (CCPA 1977) (emphasis in
original) (citations omitted) (The claimed wastewater treatment device
had a tank volume to contractor area of 0.12 gal./sq. ft. The court
found the invention as a whole was the ratio of 0.12 and its inherent
property that the claimed devices maximized treatment capacity
regardless of other variables in the devices. The prior art did not
recognize that treatment capacity was a function of the tank volume to
contractor ratio, and therefore the parameter optimized was not
recognized in the art to be a result-effective variable.). See also In
re Papesch, 315 F.2d 381, 391, 137 USPQ 43, 51 (CCPA 1963) ("From the
standpoint of patent law, a compound and all its properties are
inseparable.").

Obviousness cannot be predicated on what is not known at the time an
invention is made, even if the inherency of a certain feature is later
established. In re Rijckaert, 9 F.2d 1531, 28 USPQ2d 1955 (Fed. Cir.
1993). See MPEP Section  2112 for the requirements of rejections based
on inherency.

PRIOR ART MUST BE CONSIDERED IN ITS ENTIRETY, INCLUDING DISCLOSURES THAT
TEACH AWAY FROM THE CLAIMS

A prior art reference must be considered in its entirety, i.e., as a
whole, including portions that would lead away from the claimed
invention. W.L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540,
220 USPQ 303 (Fed. Cir. 1983), cert. denied, 469 U.S. 851 (1984) (Claims
were directed to a process of producing a porous article by expanding
shaped, unsintered, highly crystalline poly(tetrafluoroethylene) (PTFE)
by stretching said PTFE at a 10% per second rate to more than five times
the original length. The prior art teachings with regard to unsintered
PTFE indicated the material does not respond to conventional plastics
processing, and the material should be stretched slowly. A reference
teaching rapid stretching of conventional plastic polypropylene with
reduced crystallinity combined with a reference teaching stretching
unsintered PTFE would not suggest rapid stretching of highly crystalline
PTFE, in light of the disclosures in the art that teach away from the
invention, i.e., that the conventional polypropylene should have reduced
crystallinity before stretching, and that PTFE should be stretched
slowly.).

---SECTION---2141.03 Level of Ordinary Skill in the Art

FACTORS TO CONSIDER IN DETERMINING LEVEL OF ORDINARY SKILL

"Factors that may be considered in determining level of ordinary skill
in the art include (1) the educational level of the inventor; (2) type
of problems encountered in the art; (3) prior art solutions to those
problems; (4) rapidity with which innovations are made; (5)
sophistication of the technology; and (6) educational level of active
workers in the field." Environmental Designs, Ltd. v. Union Oil Co., 713
F.2d 693, 696, 218 USPQ 865, 868 (Fed. Cir. 1983), cert. denied, 464
U.S. 1043 (1984).

The "hypothetical `person having ordinary skill in the art' to which the
claimed subject matter pertains would, of necessity have the capability
of understanding the scientific and engineering principles applicable to
the pertinent art." Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat.
App. & Inter. 1988) (The Board disagreed with the examiner's definition
of one of ordinary skill in the art (a doctorate level engineer or
scientist working at least 40 hours per week in semiconductor research
or development), finding that the hypothetical person is not definable
by way of credentials, and that the evidence in the application did not
support the conclusion that such a person would require a doctorate or
equivalent knowledge in science or engineering.).

References which do not qualify as prior art because they postdate the
claimed invention may be relied upon to show the level of ordinary skill
in the art at or around the time the invention was made. Ex parte
Erlich, 22 USPQ 1463 (Bd. Pat. App. & Inter. 1992).

SPECIFYING A PARTICULAR LEVEL OF SKILL IS NOT NECESSARY WHERE THE PRIOR
ART ITSELF REFLECTS AN APPROPRIATE LEVEL

If the only facts of record pertaining to the level of skill in the art
are found within the prior art of record, the court has held that an
invention may be held to have been obvious without a specific finding of
a particular level of skill where the prior art itself reflects an
appropriate level. Chore-Time Equipment, Inc. v. Cumberland Corp., 713
F.2d 774, 218 USPQ 673 (Fed. Cir. 1983).

ASCERTAINING LEVEL OF ORDINARY SKILL IS NECESSARY TO MAINTAIN
OBJECTIVITY

"The importance of resolving the level of ordinary skill in the art lies
in the necessity of maintaining objectivity in the obviousness inquiry."
Ryko Mfg. Co. v. Nu-Star, Inc., 950 F.2d 714, 718, 21 USPQ2d 1053, 1057
(Fed. Cir. 1991). The examiner must ascertain what would have been
obvious to one of ordinary skill in the art at the time the invention
was made, and not to the inventor, a judge, a layman, those skilled in
remote arts, or to geniuses in the art at hand. Environmental Designs,
Ltd. v. Union Oil Co., 713 F.2d 693, 218 USPQ 865 (Fed. Cir. 1983),
cert. denied, 464 U.S. 1043 (1984).

---SECTION---2142 Legal Concept of Prima Facie Obviousness

The legal concept of prima facie obviousness is a procedural tool of
examination which applies broadly to all arts. It allocates who has the
burden of going forward with production of evidence in each step of the
examination process. See In re Rinehart, 531 F.2d 1048, 189 USPQ 143
(CCPA 1976); In re Linter, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972); In
re Saunders, 444 F.2d 599, 170 USPQ 213 (CCPA 1971); In re Tiffin, 443
F.2d 394, 170 USPQ 88 (CCPA 1971), amended, 448 F.2d 791, 171 USPQ 294
(CCPA 1971); In re Warner, 379 F.2d 1011, 154 USPQ 173 (CCPA 1967),
cert. denied, 389 U.S. 1057 (1968). The examiner bears the initial
burden of factually supporting any prima facie conclusion of
obviousness. If the examiner does not produce a prima facie case, the
applicant is under no obligation to submit evidence of nonobviousness.
If, however, the examiner does produce a prima facie case, the burden of
coming forward with evidence or arguments shifts to the applicant who
may submit additional evidence of nonobviousness, such as comparative
test data showing that the claimed invention possesses improved
properties not expected by the prior art. The initial evaluation of
prima facie obviousness thus relieves both the examiner and applicant
from evaluating evidence beyond the prior art and the evidence in the
specification as filed until the art has been shown to suggest the
claimed invention.

To reach a proper determination under  35 U.S.C. 103, the examiner must
step backward in time and into the shoes worn by the hypothetical
"person of ordinary skill in the art" when the invention was unknown and
just before it was made. In view of all factual information, the
examiner must then make a determination whether the claimed invention
"as a whole" would have been obvious at that time to that person.
Knowledge of applicant's disclosure must be put aside in reaching this
determination, yet kept in mind in order to determine the "differences,"
conduct the search and evaluate the "subject matter as a whole" of the
invention. The tendency to resort to "hindsight" based upon applicant's
disclosure is often difficult to avoid due to the very nature of the
examination process. However, impermissible hindsight must be avoided
and the legal conclusion must be reached on the basis of the facts
gleaned from the prior art.

ESTABLISHING A PRIMA FACIE CASE OF OBVIOUSNESS

To establish a prima facie case of obviousness, three basic criteria
must be met. First, there must be some suggestion or motivation, either
in the references themselves or in the knowledge generally available to
one of ordinary skill in the art, to modify the reference or to combine
reference teachings. Second, there must be a reasonable expectation of
success. Finally, the prior art reference (or references when combined)
must teach or suggest all the claim limitations. The teaching or
suggestion to make the claimed combination and the reasonable
expectation of success must both be found in the prior art, and not
based on applicant's disclosure. In re Vaeck, 947 F.2d 488, 20 USPQ2d
1438 (Fed. Cir. 1991). See MPEP Section  2143 -  Section  2143.03 for
decisions pertinent to each of these criteria.

The initial burden is on the examiner to provide some suggestion of the
desirability of doing what the inventor has done. "To support the
conclusion that the claimed invention is directed to obvious subject
matter, either the references must expressly or impliedly suggest the
claimed invention or the examiner must present a convincing line of
reasoning as to why the artisan would have found the claimed invention
to have been obvious in light of the teachings of the references." Ex
parte Clapp, 227 USPQ 972, 973 (Bd. Pat. App. & Inter. 1985). See MPEP
Section  2144 -  Section  2144.09 for examples of reasoning supporting
obviousness rejections.

When the motivation to combine the teachings of the references is not
immediately apparent, it is the duty of the examiner to explain why the
combination of the teachings is proper. Ex parte Skinner, 2 USPQ2d 1788
(Bd. Pat. App. & Inter. 1986). A statement of a rejection that includes
a large number of rejections must explain with reasonable specificity at
least one rejection, otherwise the examiner procedurally fails to
establish a prima facie case of obviousness. Ex parte Blanc, 13 USPQ2d
1383 (Bd. Pat. App. & Inter. 1989) (Rejection based on nine references
which included at least 40 prior art rejections without explaining any
one rejection with reasonable specificity was reversed as procedurally
failing to establish a prima facie case of obviousness.).

If the examiner determines there is factual support for rejecting the
claimed invention under  35 U.S.C. 103, the examiner must then consider
any evidence supporting the patentability of the claimed invention, such
as any evidence in the specification or any other evidence submitted by
the applicant. The ultimate determination of patentability is based on
the entire record, by a preponderance of evidence, with due
consideration to the persuasiveness of any arguments and any secondary
evidence. In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992).
The legal standard of "a preponderance of evidence" requires the
evidence to be more convincing than the evidence which is offered in
opposition to it. With regard to rejections under  35 U.S.C. 103, the
examiner must provide evidence which as a whole shows that the legal
determination sought to be proved (i.e., the reference teachings
establish a prima facie case of obviousness) is more probable than not.

When an applicant submits evidence, whether in the specification as
originally filed or in reply to a rejection, the examiner must
reconsider the patentability of the claimed invention. The decision on
patentability must be made based upon consideration of all the evidence,
including the evidence submitted by the examiner and the evidence
submitted by the applicant. A decision to make or maintain a rejection
in the face of all the evidence must show that it was based on the
totality of the evidence. Facts established by rebuttal evidence must be
evaluated along with the facts on which the conclusion of obviousness
was reached, not against the conclusion itself. In re Eli Lilly & Co.,
902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990).

See In re Piasecki, 745 F.2d 1468, 223 USPQ 785 (Fed. Cir. 1984) for a
discussion of the proper roles of the examiner's prima facie case and
applicant's rebuttal evidence in the final determination of obviousness.
See MPEP Section  706.02(j) for a discussion of the proper contents of a
rejection under  35 U.S.C. 103.

---SECTION---2143 Basic Requirements of a Prima Facie Case of
Obviousness

To establish a prima facie case of obviousness, three basic criteria
must be met. First, there must be some suggestion or motivation, either
in the references themselves or in the knowledge generally available to
one of ordinary skill in the art, to modify the reference or to combine
reference teachings. Second, there must be a reasonable expectation of
success. Finally, the prior art reference (or references when combined)
must teach or suggest all the claim limitations.

The teaching or suggestion to make the claimed combination and the
reasonable expectation of success must both be found in the prior art,
not in applicant's disclosure. In re Vaeck, 947 F.2d 488, 20 USPQ2d 1438
(Fed. Cir. 1991).

---SECTION---2143.01 Suggestion or Motivation to Modify the References

THE PRIOR ART MUST SUGGEST THE DESIRABILITY OF THE CLAIMED INVENTION

"In determining the propriety of the Patent Office case for obviousness
in the first instance, it is necessary to ascertain whether or not the
reference teachings would appear to be sufficient for one of ordinary
skill in the relevant art having the reference before him to make the
proposed substitution, combination, or other modification." In re
Linter, 458 F.2d 1013, 1016, 173 USPQ 560, 562 (CCPA 1972).

Obviousness can only be established by combining or modifying the
teachings of the prior art to produce the claimed invention where there
is some teaching, suggestion, or motivation to do so found either in the
references themselves or in the knowledge generally available to one of
ordinary skill in the art. In re Fine, 837 F.2d 1071, 5 USPQ2d 1596
(Fed. Cir. 1988); In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir.
1992).

In In re Fine, the claims were directed to a system for detecting and
measuring minute quantities on nitrogen compounds comprising a gas
chromatograph, a converter which converts nitrogen compounds into nitric
oxide by combustion, and a nitric oxide detector. The primary reference
disclosed a system for monitoring sulfur compounds comprising a
chromatograph, combustion means, and a detector, and the secondary
reference taught nitric oxide detectors. The examiner and Board asserted
that it would have been within the skill of the art to substitute one
type of detector for another in the system of the primary reference,
however the court found there was no support or explanation of this
conclusion and reversed.

In In re Jones, the claimed invention was the 2-(2&cent;-aminoethoxy)
ethanol salt of dicamba, a compound with herbicidal activity. The
primary reference disclosed inter alia the substituted ammonium salts of
dicamba as herbicides, however the reference did not specifically teach
the claimed salt. Secondary references teaching the amine portion of the
salt were directed to shampoo additives and a byproduct of the
production of morpholine. The court found there was no suggestion to
combine these references to arrive at the claimed invention.

WHERE THE TEACHINGS OF THE PRIOR ART CONFLICT, THE EXAMINER MUST WEIGH
THE SUGGESTIVE POWER OF EACH REFERENCE

The test for obviousness is what the combined teachings of the
references would have suggested to one of ordinary skill in the art, and
all teachings in the prior art must be considered to the extent that
they are in analogous arts. Where the teachings of two or more prior art
references conflict, the examiner must weigh the power of each reference
to suggest solutions to one of ordinary skill in the art, considering
the degree to which one reference might accurately discredit another. In
re Young, 927 F.2d 588, 18 USPQ2d 1089 (Fed. Cir. 1991) (Prior art
patent to Carlisle disclosed controlling and minimizing bubble
oscillation for chemical explosives used in marine seismic exploration
by spacing seismic sources close enough to allow the bubbles to
intersect before reaching their maximum radius so the secondary pressure
pulse was reduced. An article published several years later by Knudsen
opined that the Carlisle technique does not yield appreciable
improvement in bubble oscillation suppression. However, the article did
not test the Carlisle technique under comparable conditions because
Knudsen did not use Carlisle's spacing or seismic source. Furthermore,
where the Knudsen model most closely approximated the patent technique
there was a 30% reduction of the secondary pressure pulse. On these
facts, the court found that the Knudsen article would not have deterred
one of ordinary skill in the art from using the Carlisle patent
teachings.).

FACT THAT REFERENCES CAN BE COMBINED OR MODIFIED IS NOT SUFFICIENT TO
ESTABLISH PRIMA FACIE OBVIOUSNESS

The mere fact that references can be combined or modified does not
render the resultant combination obvious unless the prior art also
suggests the desirability of the combination. In re Mills, 916 F.2d 680,
16 USPQ2d 1430 (Fed. Cir. 1990) (Claims were directed to an apparatus
for producing an aerated cementitious composition by drawing air into
the cementitious composition by driving the output pump at a capacity
greater than the feed rate. The prior art reference taught that the feed
means can be run at a variable speed, however the court found that this
does not require that the output pump be run at the claimed speed so
that air is drawn into the mixing chamber and is entrained in the
ingredients during operation. Although a prior art device "may be
capable of being modified to run the way the apparatus is claimed, there
must be a suggestion or motivation in the reference to do so." 916 F.2d
at 682, 16 USPQ2d at 1432.). See also In re Fritch, 972 F.2d 1260, 23
USPQ2d 1780 (Fed. Cir. 1992) (flexible landscape edging device which is
conformable to a ground surface of varying slope not suggested by
combination of prior art references).

FACT THAT THE CLAIMED INVENTION IS WITHIN THE CAPABILITIES OF ONE OF
ORDINARY SKILL IN THE ART IS NOT SUFFICIENT BY ITSELF TO ESTABLISH PRIMA
FACIE OBVIOUSNESS

A statement that modifications of the prior art to meet the claimed
invention would have been "`  well within the ordinary skill of the art
at the time the claimed invention was made'" because the references
relied upon teach that all aspects of the claimed invention were
individually known in the art is not sufficient to establish a prima
facie case of obviousness without some objective reason to combine the
teachings of the references.   Ex parte Levengood, 28 USPQ2d 1300 (Bd.
Pat. App. & Inter. 1993).

THE PROPOSED MODIFICATION CANNOT RENDER THE PRIOR ART UNSATISFACTORY FOR
ITS INTENDED PURPOSE

If proposed modification would render the prior art invention being
modified unsatisfactory for its intended purpose, then there is no
suggestion or motivation to make the proposed modification. In re
Gordon, 733 F.2d 900, 221 USPQ 1125 (Fed. Cir. 1984) (Claimed device was
a blood filter assembly for use during medical procedures wherein both
the inlet and outlet for the blood were located at the bottom end of the
filter assembly, and wherein a gas vent was present at the top of the
filter assembly. The prior art reference taught a liquid strainer for
removing dirt and water from gasoline and other light oils wherein the
inlet and outlet were at the top of the device, and wherein a pet-cock
(stopcock) was located at the bottom of the device for periodically
removing the collected dirt and water. The reference further taught that
the separation is assisted by gravity. The Board concluded the claims
were prima facie obvious, reasoning that it would have been obvious to
turn the reference device upside down. The court reversed, finding that
if the prior art device was turned upside down it would be inoperable
for its intended purpose because the gasoline to be filtered would be
trapped at the top, the water and heavier oils sought to be separated
would flow out of the outlet instead of the purified gasoline, and the
screen would become clogged.).

THE PROPOSED MODIFICATION CANNOT CHANGE THE PRINCIPLE OF OPERATION OF A
REFERENCE

If the proposed modification or combination of the prior art would
change the principle of operation of the prior art invention being
modified, then the teachings of the references are not sufficient to
render the claims prima facie obvious. In re Ratti, 270 F.2d 810, 123
USPQ 349 (CCPA 1959) (Claims were directed to an oil seal comprising a
bore engaging portion with outwardly biased resilient spring fingers
inserted in a resilient sealing member. The primary reference relied
upon in a rejection based on a combination of references disclosed an
oil seal wherein the bore engaging portion was reinforced by a
cylindrical sheet metal casing. Patentee taught the device required
rigidity for operation, whereas the claimed invention required
resiliency. The court reversed the rejection holding the "suggested
combination of references would require a substantial reconstruction and
redesign of the elements shown in [the primary reference] as well as a
change in the basic principle under which the [primary reference]
construction was designed to operate." 270 F.2d at 813, 123 USPQ at
352.).

---SECTION---2143.02 Reasonable Expectation of Success Is Required

OBVIOUSNESS REQUIRES ONLY A REASONABLE EXPECTATION OF SUCCESS

The prior art can be modified or combined to reject claims as prima
facie obvious as long as there is a reasonable expectation of success.
In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986)
(Claims directed to a method of treating depression with amitriptyline
(or nontoxic salts thereof) were rejected as prima facie obvious over
prior art disclosures that amitriptyline is a compound known to possess
psychotropic properties and that imipramine is a structurally similar
psychotropic compound known to possess antidepressive properties, in
view of prior art suggesting the aforementioned compounds would be
expected to have similar activity because the structural difference
between the compounds involves a known bioisosteric replacement and
because a research paper comparing the pharmacological properties of
these two compounds suggested clinical testing of amitriptyline as an
antidepressant. The court sustained the rejection, finding that the
teachings of the prior art provide a sufficient basis for a reasonable
expectation of success.); Ex parte Blanc, 13 USPQ2d 1383 (Bd. Pat. App.
& Inter. 1989) (Claims were directed to a process of sterilizing a
polyolefinic composition with high-energy radiation in the presence of a
phenolic polyester antioxidant to inhibit discoloration or degradation
of the polyolefin. Appellant argued that it is unpredictable whether a
particular antioxidant will solve the problem of discoloration or
degradation. However, the Board found that because the prior art taught
that appellant's preferred antioxidant is very efficient and provides
better results compared with other prior art antioxidants, there would
have been a reasonable expectation of success.).

AT LEAST SOME DEGREE OF PREDICTABILITY IS REQUIRED; APPLICANTS MAY
PRESENT EVIDENCE SHOWING THERE WAS NO REASONABLE EXPECTATION OF SUCCESS

Obviousness does not require absolute predictability, however, at least
some degree of predictability is required. Evidence showing there was no
reasonable expectation of success may support a conclusion of
nonobviousness. In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976)
(Claims directed to a method for the commercial scale production of
polyesters in the presence of a solvent at superatmospheric pressure
were rejected as obvious over a reference which taught the claimed
method at atmospheric pressure in view of a reference which taught the
claimed process except for the presence of a solvent. The court
reversed, finding there was no reasonable expectation that a process
combining the prior art steps could be successfully scaled up in view of
unchallenged evidence showing that the prior art processes individually
could not be commercially scaled up successfully.). See also Amgen, Inc.
v. Chugai Pharmaceutical Co., 927 F.2d 1200, 1207-08, 18 USPQ2d 1016,
1022-23 (Fed. Cir.), cert. denied, 502 U.S. 856 (1991) (In the context
of a biotechnology case, testimony supported the conclusion that the
references did not show that there was a reasonable expectation of
success.);  In re O'Farrell, 853 F.2d 894, 903, 7 USPQ2d 1673, 1681
(Fed. Cir. 1988) (The court held the claimed method would have been
obvious over the prior art relied upon because one reference contained a
detailed enabling methodology, a suggestion to modify the prior art to
produce the claimed invention, and evidence suggesting the modification
would be successful.).

PREDICTABILITY IS DETERMINED AT THE TIME THE INVENTION WAS MADE

Whether an art is predictable or whether the proposed modification or
combination of the prior art has a reasonable expectation of success is
determined at the time the invention was made. Ex parte Erlich, 3 USPQ2d
1011 (Bd. Pat. App. & Inter. 1986) (Although an earlier case reversed a
rejection because of unpredictability in the field of monoclonal
antibodies, the court found "  in this case at the time this invention
was made, one of ordinary skill in the art would have been motivated to
produce monoclonal antibodies specific for human fibroplast interferon
using the method of [the prior art] with a reasonable expectation of
success." 3 USPQ2d at 1016 (emphasis in original).).

---SECTION---2143.03 All Claim Limitations Must Be Taught or Suggested

To establish prima facie obviousness of a claimed invention, all the
claim limitations must be taught or suggested by the prior art. In re
Royka, 490 F.2d 981, 180 USPQ 580 (CCPA 1974). "All words in a claim
must be considered in judging the patentability of that claim against
the prior art." In re Wilson, 424 F.2d 1382, 1385,  165 USPQ 494, 496
(CCPA 1970). If an independent claim is nonobvious under  35 U.S.C. 103,
then any claim depending therefrom is nonobvious. In re Fine, 837 F.2d
1071, 5 USPQ2d 1596 (Fed. Cir. 1988).

INDEFINITE LIMITATIONS MUST BE CONSIDERED

A claim limitation which is considered indefinite cannot be disregarded.
If a claim is subject to more than one interpretation, at least one of
which would render the claim unpatentable over the prior art, the
examiner should reject the claim as indefinite under  35 U.S.C. 112,
second paragraph (see MPEP Section  706.03(d)) and should reject the
claim over the prior art based on the interpretation of the claim that
renders the prior art applicable. Ex parte Ionescu, 222 USPQ 537 (Bd.
Pat. App. & Inter. 1984) (Claims on appeal were rejected on
indefiniteness grounds only; the rejection was reversed and the case
remanded to the examiner for consideration of pertinent prior art.).
Compare In re Wilson, 424 F.2d 1382, 165 USPQ 494 (CCPA 1970) (if no
reasonably definite meaning can be ascribed to certain claim language,
the claim is indefinite, not obvious) and In re Steele, 305 F.2d 859,134
USPQ 292 (CCPA 1962) (it is improper to rely on speculative assumptions
regarding the meaning of a claim and then base a rejection under  35
U.S.C. 103 on these assumptions).

LIMITATIONS WHICH DO NOT FIND SUPPORT IN THE ORIGINAL SPECIFICATION MUST
BE CONSIDERED

When evaluating claims for obviousness under  35 U.S.C. 103, all the
limitations of the claims must be considered and given weight, including
limitations which do not find support in the specification as originally
filed (i.e., new matter). Ex parte Grasselli, 231 USPQ 393 (Bd. App.
1983) aff'd mem. 738 F.2d 453 (Fed. Cir. 1984) (Claim to a catalyst
expressly excluded the presence of sulfur, halogen, uranium, and a
combination of vanadium and phosphorous. Although the negative
limitations excluding these elements did not appear in the specification
as filed, it was error to disregard these limitations when determining
whether the claimed invention would have been obvious in view of the
prior art.).

---SECTION---2144 Sources of Rationale Supporting a Rejection Under 35
U.S.C. 103

RATIONALE MAY BE IN A REFERENCE, OR REASONED FROM COMMON KNOWLEDGE IN
THE ART, SCIENTIFIC PRINCIPLES, ART- RECOGNIZED EQUIVALENTS, OR LEGAL
PRECEDENT

The rationale to modify or combine the prior art does not have to be
expressly stated in the prior art; the rationale may be expressly or
impliedly contained in the prior art or it may be reasoned from
knowledge generally available to one of ordinary skill in the art,
established scientific principles, or legal precedent established by
prior case law. In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir.
1988); In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992). See
also In re Eli Lilly & Co., 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir.
1990) (discussion of reliance on legal precedent); In re Nilssen, 851
F.2d 1401, 1403, 7 USPQ2d 1500, 1502 (Fed. Cir. 1988) (references do not
have to explicitly suggest combining teachings); Ex parte Clapp, 227
USPQ 972 (Bd. Pat. App. & Inter. 1985) (examiner must present convincing
line of reasoning supporting rejection); and Ex parte Levengood, 28
USPQ2d 1300 (Bd. Pat. App. & Inter. 1993) (reliance on logic and sound
scientific reasoning).

THE EXPECTATION OF SOME ADVANTAGE IS THE STRONGEST RATIONALE FOR
COMBINING REFERENCES

The strongest rationale for combining references is a recognition,
expressly or impliedly in the prior art or drawn from a convincing line
of reasoning based on established scientific principles or legal
precedent, that some advantage or expected beneficial result would have
been produced by their combination. In re Sernaker, 702 F.2d 989,
994-95, 217 USPQ 1, 5-6 (Fed. Cir. 1983).

LEGAL PRECEDENT CAN PROVIDE THE RATIONALE SUPPORTING OBVIOUSNESS ONLY IF
THE FACTS IN THE CASE ARE SUFFICIENTLY SIMILAR TO THOSE IN THE
APPLICATION

The examiner must apply the law consistently to each application after
considering all the relevant facts. If the facts in a prior legal
decision are sufficiently similar to those in an application under
examination, the examiner may use the rationale used by the court. If
the applicant has demonstrated the criticality of a specific limitation,
it would not be appropriate to rely solely on case law as the rationale
to support an obviousness rejection. "The value of the exceedingly large
body of precedent wherein our predecessor courts and this court have
applied the law of obviousness to particular facts, is that there has
been built a wide spectrum of illustrations and accompanying reasoning,
that have been melded into a fairly consistent application of law to a
great variety of facts." In re Eli Lilly & Co., 902 F.2d 943, 14 USPQ2d
1741 (Fed. Cir. 1990).

RATIONALE DIFFERENT FROM APPLICANT'S IS PERMISSIBLE

The reason or motivation to modify the reference may often suggest what
the inventor has done, but for a different purpose or to solve a
different problem. It is not necessary that the prior art suggest the
combination to achieve the same advantage or result discovered by
applicant. In re Linter, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972)
(discussed below); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir.
1990), cert. denied, 500 U.S. 904 (1991) (discussed below). Although Ex
parte Levengood, 28 USPQ2d 1300, 1302 (Bd. Pat. App. & Inter. 1993)
states that obviousness cannot be established by combining references
"without also providing evidence of the motivating force which would
impel one skilled in the art to do what the patent applicant has done"
(emphasis added), reading the quotation in context it is clear that
while there must be motivation to make the claimed invention, there is
no requirement that the prior art provide the same reason as the
applicant to make the claimed invention.

In In re Linter the claimed invention was a laundry composition
consisting essentially of a dispersant, cationic fabric softener, sugar,
sequestering phosphate, and brightener in specified proportions. The
claims were rejected over the combination of a primary reference which
taught all the claim limitations except for the presence of sugar, and
secondary references which taught the addition of sugar as a filler or
weighting agent in compositions containing cationic fabric softeners.
Appellant argued that in the claimed invention, the sugar is responsible
for the compatibility of the cationic softener with the other detergent
components. The court sustained the rejection, stating "The fact that
appellant uses sugar for a different purpose does not alter the
conclusion that its use in a prior art composition would be [sic, would
have been] prima facie obvious from the purpose disclosed in the
references." 173 USPQ at 562.

In In re Dillon, applicant claimed a composition comprising a
hydrocarbon fuel and a sufficient amount of a tetra-orthoester of a
specified formula to reduce the particulate emissions from the
combustion of the fuel. The claims were rejected as obvious over a
reference which taught hydrocarbon fuel compositions containing
tri-orthoesters for dewatering fuels, in combination with a reference
teaching the equivalence of tri-orthoesters and tetra-orthoesters as
water scavengers in hydraulic (nonhydrocarbon) fluids. The Board
affirmed the rejection finding "there was a `reasonable expectation'
that the tri- and tetra-orthoester fuel compositions would have similar
properties based on `close structural and chemical similarity' between
the tri- and tetra-orthoesters and the fact that both the prior art and
Dillon use these compounds `as fuel additives'." 919 F.2d at 692, 16
USPQ2d at 1900. The court held "it is not necessary in order to
establish a prima facie case of obviousness . . . that there be a
suggestion or expectation from the prior art that the claimed
[invention] will have the same or a similar utility as one newly
discovered by applicant," and concluded that here a prima facie case was
established because "[t]he art provided the motivation to make the
claimed compositions in the expectation that they would have similar
properties." 919 F.2d at 693, 16 USPQ2d at 1901 (emphasis in original).

See MPEP Section  2145, paragraph II for case law pertaining to the
presence of additional advantages or latent properties not recognized in
the prior art.

---SECTION---2144.01 Implicit Disclosure

"[I]n considering the disclosure of a reference, it is proper to take
into account not only specific teachings of the reference but also the
inferences which one skilled in the art would reasonably be expected to
draw therefrom." In re Preda, 401 F.2d 825, 826, 159 USPQ 342, 344 (CCPA
1968) (A process for catalytically producing carbon disulfide by
reacting sulfur vapor and methane in the presence of charcoal at a
temperature of "about 750-830C" was found to be met by a reference which
expressly taught the same process at 700C because the reference
recognized the possibility of using temperatures greater than 750C. The
reference disclosed that catalytic processes for converting methane with
sulfur vapors into carbon disulfide at temperatures greater than 750C
(albeit without charcoal) was known, and that 700C was "much lower than
had previously proved feasible."); In re Lamberti, 545 F.2d 747, 750,
192 USPQ 278, 280 (CCPA 1976) (Reference disclosure of a compound where
the R-S-R&cent;  portion has "at least one methylene group attached to
the sulfur atom" implies that the other R group attached to the sulfur
atom can be other than methylene and therefore suggests asymmetric
dialkyl moieties.).

---SECTION---2144.02 Reliance on Scientific Theory

The rationale to support a rejection under  35 U.S.C. 103 may rely on
logic and sound scientific principle. In re Soli, 317 F.2d 941, 137 USPQ
797 (CCPA 1963). However, when an examiner relies on a scientific
theory, evidentiary support for the existence and meaning of that theory
must be provided. In re Grose, 592 F.2d 1161, 201 USPQ 57 (CCPA 1979)
(Court held that different crystal forms of zeolites would not have been
structurally obvious one from the other because there was no chemical
theory supporting such a conclusion. The known chemical relationship
between structurally similar compounds (homologs, analogs, isomers) did
not support a finding of prima facie obviousness of claimed zeolite over
the prior art because a zeolite is not a compound but a mixture of
compounds related to each other by a particular crystal structure.).
Although the theoretical mechanism of an invention may be explained by
logic and sound scientific reasoning, this fact does not support an
obviousness determination unless logic and scientific reasoning would
have led one of ordinary skill in the art to make the claimed invention.
Ex parte Levengood, 28 USPQ2d 1300 (Bd. Pat. App. & Inter. 1993).

---SECTION---2144.03 Reliance on Common Knowledge in the Art or "Well
Known" Prior Art

The rationale supporting an obviousness rejection may be based on common
knowledge in the art or "well-known" prior art. The examiner may take
official notice of facts outside of the record which are capable of
instant and unquestionable demonstration as being "well- known"  in the
art. In re Ahlert, 424 F.2d 1088, 1091, 165  USPQ 418, 420 (CCPA 1970)
(Board properly took judicial notice that "it is common practice to
postheat a weld after the welding operation is completed" and that "it
is old to adjust the intensity of a flame in accordance with the heat
requirements."). See also In re Seifreid, 407 F.2d 897, 160 USPQ 804
(CCPA 1969) (Examiner's statement that polyethylene terephthalate films
are commonly known to be shrinkable is a statement of common knowledge
in the art, supported by the references of record.).

If justified, the examiner should not be obliged to spend time to
produce documentary proof. If the knowledge is of such notorious
character that official notice can be taken, it is sufficient so to
state. In re Malcolm, 129 F.2d 529, 54 USPQ 235 (CCPA 1942). If the
applicant traverses such an assertion the examiner should cite a
reference in support of his or her position.

When a rejection is based on facts within the personal knowledge of the
examiner, the data should be stated as specifically as possible, and the
facts must be supported, when called for by the applicant, by an
affidavit from the examiner. Such an affidavit is subject to
contradiction or explanation by the affidavits of the applicant and
other persons. See  37 CFR 1.104(d)(2).

Applicant must seasonably challenge well known statements and statements
based on personal knowledge when they are made by the Board of Patent
Appeals and Interferences. In re Selmi, 156 F.2d 96, 70 USPQ 197 (CCPA
1946); In re Fischer, 125 F.2d 725, 52 USPQ 473 (CCPA 1942). See also In
re Boon, 439 F.2d 724, 169 USPQ 231 (CCPA 1971) (a challenge to the
taking of judicial notice must contain adequate information or argument
to create on its face a reasonable doubt regarding the circumstances
justifying the judicial notice).

For further views on official notice, see In re Ahlert, 424 F.2d 1088,
1091, 165 USPQ 418, 420-421 (CCPA 1970) ("[A]ssertions of technical
facts in areas of esoteric technology must always be supported by
citation of some reference work" and "allegations concerning specific
`knowledge' of the prior art, which might be peculiar to a particular
art should also be supported." Furthermore the applicant must be given
the opportunity to challenge the correctness of such assertions and
allegations. "The facts so noticed serve to `fill the gaps' which might
exist in the evidentiary showing" and should not comprise the principle
evidence upon which a rejection is based.). See also In re Barr, 444
F.2d 588, 170 USPQ 330 (CCPA 1971) (scientific journal references were
not used as a basis for taking judicial notice that controverted phrases
were art-recognized because the court was not sure that the meaning of
the term at issue was indisputable among reasonable men); and In re
Eynde, 480 F.2d 1364, 1370,  178 USPQ 470, 474 (CCPA 1973) ("The facts
constituting the state of the art are normally subject to the
possibility of rational disagreement among reasonable men and are not
amenable to the taking of [judicial] notice.").

If applicant does not seasonably traverse the well known statement
during examination, then the object of the well known statement is taken
to be admitted prior art. In re Chevenard, 139 F.2d 71, 60 USPQ 239
(CCPA 1943). A seasonable challenge constitutes a demand for evidence
made as soon as practicable during prosecution. Thus, applicant is
charged with rebutting the well known statement in the next reply after
the Office action in which the well known statement was made. This is
necessary because the examiner must be given the opportunity to provide
evidence in the next Office action or explain why no evidence is
required. If the examiner adds a reference to the rejection in the next
action after applicant's rebuttal, the newly cited reference, if it is
added merely as evidence of the prior well known statement, does not
result in a new issue and thus the action can potentially be made final.
If no amendments are made to the claims, the examiner must not rely on
any other teachings in the reference if the rejection is made final.

---SECTION---2144.04 Legal Precedent as Source of Supporting Rationale

As discussed in MPEP Section  2144, if the facts in a prior legal
decision are sufficiently similar to those in an application under
examination, the examiner may use the rationale used by the court.
Examples directed to various common practices which the court has held
normally require only ordinary skill in the art and hence are considered
routine expedients are discussed below. If the applicant has
demonstrated the criticality of a specific limitation, it would not be
appropriate to rely solely on case law as the rationale to support an
obviousness rejection.

I. AESTHETIC DESIGN CHANGES

In re Seid, 161 F.2d 229, 73 USPQ 431 (CCPA 1947) (Claim was directed to
an advertising display device comprising a bottle and a hollow member in
the shape of a human figure from the waist up which was adapted to fit
over and cover the neck of the bottle, wherein the hollow member and the
bottle together give the impression of a human body. Appellant argued
that certain limitations in the upper part of the body, including the
arrangement of the arms, were not taught by the prior art. The court
found that matters relating to ornamentation only which have no
mechanical function cannot be relied upon to patentably distinguish the
claimed invention from the prior art.). But see Ex parte Hilton, 148
USPQ 356 (Bd. App. 1965) (Claims were directed to fried potato chips
with a specified moisture and fat content, whereas the prior art was
directed to french fries having a higher moisture content. While
recognizing that in some cases the particular shape of a product is of
no patentable significance, the Board held in this case the shape
(chips) is important because it results in a product which is distinct
from the reference product (french fries).).

II. ELIMINATION OF A STEP OR AN ELEMENT AND ITS FUNCTION

A. Omission of an Element and Its Function Is Obvious If the Function of
the Element Is Not Desired

Ex parte Wu, 10 USPQ 2031 (Bd. Pat. App. & Inter. 1989) (Claims at issue
were directed to a method for inhibiting corrosion on metal surfaces
using a composition consisting of epoxy resin, petroleum sulfonate, and
hydrocarbon diluent. The claims were rejected over a primary reference
which disclosed an anticorrosion composition of epoxy resin, hydrocarbon
diluent, and polybasic acid salts wherein said salts were taught to be
beneficial when employed in a freshwater environment, in view of
secondary references which clearly suggested the addition of petroleum
sulfonate to corrosion inhibiting compositions. The Board affirmed the
rejection, holding that it would have been obvious to omit the polybasic
acid salts of the primary reference where the function attributed to
such salt is not desired or required, such as in compositions for
providing corrosion resistance in environments which do not encounter
fresh water.). See also In re Larson, 340 F.2d 965, 144 USPQ 347 (CCPA
1965) (Omission of additional framework and axle which served to
increase the cargo carrying capacity of prior art mobile fluid carrying
unit would have been obvious if this feature was not desired.); and In
re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (deleting a prior art
switch member and thereby eliminating its function was an obvious
expedient).

B. Omission of an Element with Retention of the Element's Function Is an
Indicia of Unobviousness

Note that the omission of an element and retention of its function is an
indicia of unobviousness. In re Edge, 359 F.2d 896, 149 USPQ 556 (CCPA
1966) (Claims at issue were directed to a printed sheet having a thin
layer of erasable metal bonded directly to the sheet wherein said thin
layer obscured the original print until removal by erasure. The prior
art disclosed a similar printed sheet which further comprised an
intermediate transparent and erasure-proof protecting layer which
prevented erasure of the printing when the top layer was erased. The
claims were found unobvious over the prior art because the although the
transparent layer of the prior art was eliminated, the function of the
transparent layer was retained since appellant's metal layer could be
erased without erasing the printed indicia.).

III. AUTOMATING A MANUAL ACTIVITY

In re Venner, 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958) (Appellant
argued that claims to a permanent mold casting apparatus for molding
trunk pistons were allowable over the prior art because the claimed
invention combined "old permanent-mold structures together with a timer
and solenoid which automatically actuates the known pressure valve
system to release the inner core after a predetermined time has
elapsed." The court held that broadly providing an automatic or
mechanical means to replace a manual activity which accomplished the
same result is not sufficient to distinguish over the prior art.).

IV. CHANGES IN SIZE, SHAPE, OR SEQUENCE OF ADDING INGREDIENTS

A. Changes in Size/Proportion

In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955) (Claims directed to a
lumber package "of appreciable size and weight requiring handling by a
lift truck" where held unpatentable over prior art lumber packages which
could be lifted by hand because limitations relating to the size of the
package were not sufficient to patentably distinguish over the prior
art.); In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) ("mere
scaling up of a prior art process capable of being scaled up, if such
were the case, would not establish patentability in a claim to an old
process so scaled." 531 F.2d at 1053, 189 USPQ at 148.).

In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir.
1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal
Circuit held that, where the only difference between the prior art and
the claims was a recitation of relative dimensions of the claimed device
and a device having the claimed relative dimensions would not perform
differently than the prior art device, the claimed device was not
patentably distinct from the prior art device.

B. Changes in Shape

In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that
the configuration of the claimed disposable plastic nursing container
was a matter of choic which a person of ordinary skill in the art would
have found obvious absent persuasive evidence that the particular
configuration of the claimed container was significant.).

C. Changes in Sequence of Adding Ingredients

Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959) (Prior art reference
disclosing a process of making a laminated sheet wherein a base sheet is
first coated with a metallic film and thereafter impregnated with a
thermosetting material was held to render prima facie obvious claims
directed to a process of making a laminated sheet by reversing the order
of the prior art process steps.). See also In re Burhans, 154 F.2d 690,
69 USPQ 330 (CCPA 1946) (selection of any order of performing process
steps is prima facie obvious in the absence of new or unexpected
results); In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection
of any order of mixing ingredients is prima facie obvious.).

V. MAKING PORTABLE, INTEGRAL, SEPARABLE, ADJUSTABLE, OR CONTINUOUS

A. Making Portable

In re Lindberg, 194 F.2d 732, 93 USPQ 23 (CCPA 1952) (Fact that a
claimed device is portable or movable is not sufficient by itself to
patentably distinguish over an otherwise old device unless there are new
or unexpected results.).

B. Making Integral

In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) (A claim
to a fluid transporting vehicle was rejected as obvious over a prior art
reference which differed from the prior art in claiming a brake drum
integral with a clamping means, whereas the brake disc and clamp of the
prior art comprise several parts rigidly secured together as a single
unit. The court affirmed the rejection holding, among other reasons,
"that the use of a one piece construction instead of the structure
disclosed in [the prior art] would be merely a matter of obvious
engineering choice."); but see   Schenck v. Nortron Corp., 713 F.2d 782,
218 USPQ 698 (Fed. Cir. 1983) (Claims were directed to a vibratory
testing machine (a hard-bearing wheel balancer) comprising a holding
structure, a base structure, and a supporting means which form "a single
integral and gaplessly continuous piece." Nortron argued that the
invention is just making integral what had been made in four bolted
pieces. The court found this argument unpersuasive and held that the
claims were patentable because the prior art perceived a need for
mechanisms to dampen resonance, whereas the inventor eliminated the need
for dampening via the one-piece gapless support structure, showing
insight that was contrary to the understandings and expectations of the
art.).

C. Making Separable

In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961) (The
claimed structure, a lipstick holder with a removable cap, was fully met
by the prior art except that in the prior art the cap is "press fitted"
and therefore not manually removable. The court held that "if it were
considered desirable for any reason to obtain access to the end of [the
prior art's] holder to which the cap is applied, it would be obvious to
make the cap removable for that purpose.").

D. Making Adjustable

In re Stevens, 212 F.2d 197, 101 USPQ 284 (CCPA 1954) (Claims were
directed to a handle for a fishing rod wherein the handle has a
longitudinally adjustable finger hook, and the hand grip of the handle
connects with the body portion by means of a universal joint. The court
held that adjustability, where needed, is not a patentable advance, and
because there was an art-recognized need for adjustment in a fishing
rod, the substitution of a universal joint for the single pivot of the
prior art would have been obvious.).

E. Making Continuous

In re Dilnot, 319 F.2d 188, 138 USPQ 248 (CCPA 1963) (Claim directed to
a method of producing a cementitious structure wherein a stable air foam
is introduced into a slurry of cementitious material differed from the
prior art only in requiring the addition of the foam to be continuous.
The court held the claimed continuous operation would have been obvious
in light of the batch process of the prior art.).

VI. REVERSAL, DUPLICATION, OR REAR RANGEMENT OF PARTS

A. Reversal of Parts

In re Gazda, 219 F.2d 449, 104 USPQ 400 (CCPA 1955) (Prior art disclosed
a clock fixed to the stationary steering wheel column of an automobile
while the gear for winding the clock moves with steering wheel; mere
reversal of such movement, so the clock moves with wheel, was held to be
an obvious expedient.).

B. Duplication of Parts

In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) (Claims at issue
were directed to a water-tight masonry structure wherein a water seal of
flexible material fills the joints which form between adjacent pours of
concrete. The claimed water seal has a "web" which lies perpendicular to
the workface and in the joint, and a plurality of "ribs" which are
parallel to the workface, forming the following shape . The prior art
disclosed a flexible water stop for preventing passage of water between
masses of concrete in the shape of a plus sign  (+). Although the
reference did not disclose a plurality of ribs, the court held that mere
duplication of parts has no patentable significance unless a new and
unexpected result is produced.).

C. Rearrangement of Parts

In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a
hydraulic power press which read on the prior art except with regard to
the position of the starting switch were held unpatentable because
shifting the position of the starting switch would not have modified the
operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA
1975) (the particular placement of a contact in a conductivity measuring
device was held to be an obvious matter of design choice). However, "The
mere fact that a worker in the art could rearrange the parts of the
reference device to meet the terms of the claims on appeal is not by
itself sufficient to support a finding of obviousness. The prior art
must provide a motivation or reason for the worker in the art, without
the benefit of appellant's specification, to make the necessary changes
in the reference device." Ex parte Chicago Rawhide Mfg. Co., 223 USPQ
351, 353 (Bd. Pat. App. & Inter. 1984).

VII. PURIFYING AN OLD PRODUCT

Pure materials are novel vis-a-vis less pure or impure materials because
there is a difference between pure and impure materials. Therefore, the
issue is whether claims to a pure material are unobvious over the prior
art. In re Bergstrom, 427 F.2d 1394, 166 USPQ 256 (CCPA 1970). Purer
forms of known products may be patentable, but the mere purity of a
product, by itself, does not render the product unobvious. Ex parte
Gray, 10 USPQ2d 1922 (Bd. Pat. App. & Inter. 1989).

Factors to be considered in determining whether a purified form of an
old product is obvious over the prior art include whether the claimed
chemical compound or composition has the same utility as closely related
materials in the prior art, and whether the prior art suggests the
particular form or structure of the claimed material or suitable methods
of obtaining that form or structure. In re Cofer, 354 F.2d 664, 148 USPQ
268 (CCPA 1966) (Claims to the free-flowing crystalline form of a
compound were held unobvious over references disclosing the viscous
liquid form of the same compound because the prior art of record did not
suggest the claimed compound in crystalline form or how to obtain such
crystals.).

See also Ex parte Stern, 13 USPQ2d 1379 (Bd. Pat. App. & Inter. 1987)
(Claims to interleukin 2 (a protein with a molecular weight of over
12,000) purified to homogeneity were held unpatentable over references
which recognized the desirability of purifying interleukin 2 to
homogeneity in a view of a reference which taught a method of purifying
proteins having molecular weights in excess of 12,000 to homogeneity
wherein the prior art method was similar to the method disclosed by
appellant for purifying interleukin 2.).

Compare   Ex parte Gray, 10 USPQ2d 1922 (Bd. Pat. App. & Inter. 1989)
(Claims were directed to human nerve growth factor b-NGF free from other
proteins of human origin, and the specification disclosed making the
claimed factor through the use of recombinant DNA technology. The claims
were rejected as prima facie obvious in view of two references
disclosing b-NGF isolated from human placental tissue. The Board applied
case law pertinent to product-by-process claims, reasoning that the
prior art factor appeared to differ from the claimed factor only in the
method of obtaining the factor. The Board held that the burden of
persuasion was on appellant to show that the claimed product exhibited
unexpected properties compared with that of the prior art. The Board
further noted that "no objective evidence has been provided establishing
that no method was known to those skilled in this field whereby the
claimed material might have been synthesized." 10 USPQ2d at 1926.).

---SECTION---2144.05 Obviousness of Ranges

See MPEP Section  2131.03 for case law pertaining to rejections based on
the anticipation of ranges under  35 U.S.C. 102 and  35 U.S.C. 102/103.

I. OVERLAP OF RANGES

In the case where the claimed ranges "overlap or lie inside ranges
disclosed by the prior art" a prima facie case of obviousness exists. In
re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919
F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon
monoxide concentrations of "about 1-5%" while the claim was limited to
"more than 5%." The court held that "about 1-5%" allowed for
concentrations slightly above 5% thus the ranges overlapped.); In re
Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66  (Fed. Cir.
1997) (Claim reciting thickness of a protective layer as falling within
a range of "50 to 100 Angstroms" considered   prima facie obvious in
view of prior art reference teaching that "for suitable protection, the
thickness of the protective layer should be not less than about 10 nm
[i.e., 100 Angstroms]."  The court stated that "by stating that
`suitable protection' is provided if the protective layer is `about' 100
Angstroms thick, [the prior art reference] directly teaches the use of a
thickness within [applicant's] claimed range."). Similarly, a prima
facie case of obviousness exists where the claimed ranges and prior art
ranges do not overlap but are close enough that one skilled in the art
would have expected them to have the same properties. Titanium Metals
Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985)
(Court held as proper a rejection of a claim directed to an alloy of
"having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium"
as obvious over a reference disclosing alloys of 0.75% nickel, 0.25%
molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance
titanium.).

II. OPTIMIZATION OF RANGES

A. Optimization Within Prior Art Conditions or Through Routine
Experimentation

Generally, differences in concentration or temperature will not support
the patentability of subject matter encompassed by the prior art unless
there is evidence indicating such concentration or temperature is
critical. "[W]here the general conditions of a claim are disclosed in
the prior art, it is not inventive to discover the optimum or workable
ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105
USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a
temperature between 40C and 80C and an acid concentration between 25 and
70% was held to be prima facie obvious over a reference process which
differed from the claims only in that the reference process was
performed at a temperature of 100C and an acid concentration of 10%.).
See also In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969)
(Claimed elastomeric polyurethanes which fell within the broad scope of
the references were held to be unpatentable thereover because, among
other reasons, there was no evidence of the criticality of the claimed
ranges of molecular weight or molar proportions.). For more recent cases
applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories
Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S.
975 (1989);   In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir.
1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir.
1997).

B. Only Result-effective Variables Can Be Optimized

A particular parameter must first be recognized as a result-effective
variable, i.e., a variable which achieves a recognized result, before
the determination of the optimum or workable ranges of said variable
might be characterized as routine experimentation. In re Antonie, 559
F.2d 618, 195 USPQ 6 (CCPA 1977) (The claimed wastewater treatment
device had a tank volume to contractor area of 0.12 gal./sq. ft. The
prior art did not recognize that treatment capacity is a function of the
tank volume to contractor ratio, and therefore the parameter optimized
was not recognized in the art to be a result- effective variable.). See
also In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980) (prior art
suggested proportional balancing to achieve desired results in the
formation of an alloy).

III. REBUTTAL OF PRIMA FACIE CASE OF OBVIOUSNESS

Applicants can rebut a prima facie case of obviousness based on
overlapping ranges by showing the criticality of the claimed range. "The
law is replete with cases in which the difference between the claimed
invention and the prior art is some range or other variable within the
claims. . . . In such a situation, the applicant must show that the
particular range is critical, generally by showing that the claimed
range achieves unexpected results relative to the prior art range." In
re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP
Section  716.02 -  Section  716.02(g) for a discussion of criticality
and unexpected results.

A prima facie case of obviousness may also be rebutted by showing that
the art, in any material respect, teaches away from the claimed
invention. In re Geisler, 116 F.3d 1465, 1471, 43 USPQ2d 1362, 1366 
(Fed. Cir. 1997) (Applicant argued that the prior art taught away from
use of a protective layer for a reflective article having a thickness
within the claimed range of "50 to 100 Angstroms." Specifically, a
patent to Zehender, which was relied upon to reject applicant's claim,
included a statement that the thickness of the protective layer "should
be not less than about [100 Angstroms]."  The court held that the patent
did not teach away from the claimed invention.  "Zehender suggests that
there are benefits to be derived from keeping the protective layer as
thin as possible, consistent with achieving adequate protection.  A
thinner coating reduces light absorption and minimizes manufacturing
time and expense. Thus, while Zehender expresses a preference for a
thicker protective layer of 200-300 Angstroms, at the same time it
provides the motivation for one of ordinary skill in the art to focus on
thickness levels at the bottom of Zehender's `suitable' range- about 100
Angstroms- and to explore thickness levels below that range.  The
statement in Zehender that `[i]n general, the thickness of the
protective layer should be not less than about [100 Angstroms]' falls
far short of the kind of teaching that would discourage one of skill in
the art from fabricating a protective layer of 100 Angstroms or less.
[W]e are therefore `not convinced that there was a sufficient teaching
away in the art to overcome [the] strong case of obviousness' made out
by Zehender.").  See MPEP Section   2145, paragraph X.D., for a
discussion of "teaching away" references.

---SECTION---2144.06 Art Recognized Equivalence for the Same Purpose

COMBINING EQUIVALENTS KNOWN FOR THE SAME PURPOSE

"It is prima facie obvious to combine two compositions each of which is
taught by the prior art to be useful for the same purpose, in order to
form a third composition to be used for the very same purpose. . . .
[T]he idea of combining them flows logically from their having been
individually taught in the prior art." In re Kerkhoven, 626 F.2d 846,
850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a
process of preparing a spray-dried detergent by mixing together two
conventional spray-dried detergents were held to be prima facie
obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA
1960) (Claims directed to a method and material for treating cast iron
using a mixture comprising calcium carbide and magnesium oxide were held
unpatentable over prior art disclosures that the aforementioned
components individually promote the formation of a nodular structure in
cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. &
Inter. 1992) (mixture of two known herbicides held prima facie obvious).
But see In re Geiger, 815 F.2d 686, 2 USPQ2d 1276 (Fed. Cir. 1987)
("Based upon the prior art and the fact that each of the three
components of the composition used in the claimed method is
conventionally employed in the art for treating cooling water systems,
the board held that it would have been prima facie obvious, within the
meaning of  35 U.S.C. 103, to employ these components in combination for
their known functions and to optimize the amount of each additive....
Appellant argues ... hindsight reconstruction or at best, ... `obvious
to try'.... We agree with appellant.").

SUBSTITUTING EQUIVALENTS KNOWN FOR THE SAME PURPOSE

In order to rely on equivalence as a rationale supporting an obviousness
rejection, the equivalency must be recognized in the prior art, and
cannot be based on applicant's disclosure or the mere fact that the
components at issue are functional or mechanical equivalents. In re
Ruff, 256 F.2d 590, 118 USPQ 340 (CCPA 1958) (The mere fact that
components are claimed as members of a Markush group cannot be relied
upon to establish the equivalency of these components. However, an
applicant's express recognition of an art-recognized or obvious
equivalent may be used to refute an argument that such equivalency does
not exist.); In re Scott, 323 F.2d 1016, 139 USPQ 297 (CCPA 1963)
(Claims were drawn to a hollow fiberglass shaft for archery and a
process for the production thereof where the shaft differed from the
prior art in the use of a paper tube as the core of the shaft as
compared with the light wood or hardened foamed resin core of the prior
art. The Board found the claimed invention would have been obvious,
reasoning that the prior art foam core is the functional and mechanical
equivalent of the claimed paper core. The court reversed, holding that
components which are functionally or mechanically equivalent are not
necessarily obvious in view of one another, and in this case, the use of
a light wood or hardened foam resin core does not fairly suggest the use
of a paper core.); Smith v. Hayashi, 209 USPQ 754 (Bd. of Pat. Inter.
1980) (The mere fact that phthalocyanine and selenium function as
equivalent photoconductors in the claimed environment was not sufficient
to establish that one would have been obvious over the other. However,
there was evidence that both phthalocyanine and selenium were known
photoconductors in the art of electrophotography. "This, in our view,
presents strong evidence of obviousness in substituting one for the
other in an electrophotographic environment as a photoconductor." 209
USPQ at 759.).

An express suggestion to substitute one equivalent component or process
for another is not necessary to render such substitution obvious. In re
Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982).

---SECTION---2144.07 Art Recognized Suitability for an Intended Purpose

The selection of a known material based on its suitability for its
intended use supported a prima facie obviousness determination in
Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297
(1945) (Claims to a printing ink comprising a solvent having the vapor
pressure characteristics of butyl carbitol so that the ink would not dry
at room temperature but would dry quickly upon heating were held invalid
over a reference teaching a printing ink made with a different solvent
that was nonvolatile at room temperature but highly volatile when heated
in view of an article which taught the desired boiling point and vapor
pressure characteristics of a solvent for printing inks and a catalog
teaching the boiling point and vapor pressure characteristics of butyl
carbitol. "Reading a list and selecting a known compound to meet known
requirements is no more ingenious than selecting the last piece to put
in the last opening in a jig-saw puzzle." 325 U.S. at 335, 65 USPQ at
301.).

See also In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960) (selection
of a known plastic to make a container of a type made of plastics prior
to the invention was held to be obvious); Ryco, Inc. v. Ag-Bag Corp.,
857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988) (Claimed agricultural
bagging machine, which differed from a prior art machine only in that
the brake means were hydraulically operated rather than mechanically
operated, was held to be obvious over the prior art machine in view of
references which disclosed hydraulic brakes for performing the same
function, albeit in a different environment.).

---SECTION---2144.08 Obviousness of Species When Prior Art Teaches Genus

I. INTERIM GUIDELINES FOR THE EXAMINATION OF CLAIMS DIRECTED TO SPECIES
OF CHEMICAL COMPOSITIONS BASED UPON A SINGLE PRIOR ART REFERENCE

These "Genus-Species Guidelines" are to assist Office personnel in the
examination of applications which contain claims to species or a
subgenus of chemical compositions for compliance with  35 U.S.C. 103
based upon a single prior art reference which discloses a genus
encompassing the claimed species or subgenus but does not expressly
disclose the particular claimed species or subgenus. Office personnel
should attempt to find additional prior art to show that the differences
between the prior art primary reference and the claimed invention as a
whole would have been obvious.  Where such additional prior art is not
found, Office personnel should follow these guidelines to determine
whether a single reference  35 U.S.C. 103 rejection would be
appropriate. The guidelines are based on the Office's current
understanding of the law and are believed to be fully consistent with
binding precedent of the Supreme Court, the Federal Circuit, and the
Federal Circuit's predecessor courts.

The analysis of the guidelines begins at the point during examination
after a single prior art reference is found disclosing a genus
encompassing the claimed species or subgenus.  Before reaching this
point, Office personnel should follow normal examination procedures. 
Accordingly, Office personnel should first analyze the claims as a whole
in light of and consistent with the written description, considering all
claim limitations. When evaluating the scope of a claim, every
limitation in the claim must be considered.  See, e.g., In re Ochiai, 71
F.3d 1565, 1572, 37 USPQ2d 1127, 1133 (Fed. Cir. 1995).  However, the
claimed invention may not be dissected into discrete elements to be
analyzed in isolation, but must be considered as a whole. See, e.g.,
W.L. Gore & Assoc., Inc. v. Garlock, Inc., 721 F.2d 1540, 1548, 220 USPQ
303, 309 (Fed. Cir. 1983), cert. denied, 469 U.S. 851 (1984); Jones v.
Hardy, 727 F.2d 1524, 1530, 220 USPQ 1021, 1026 (Fed. Cir. 1983)
("treating the advantage as the invention disregards the statutory
requirement that the invention be viewed `as a whole' ").  Next, Office
personnel should conduct a thorough search of the prior art and identify
all relevant references. Both claimed and unclaimed aspects of the
invention should be searched if there is a reasonable expectation that
the unclaimed aspects may be later claimed. If the most relevant prior
art consists of a single prior art reference disclosing a genus
encompassing the claimed species or subgenus, Office personnel should
follow the guidelines set forth herein.

These guidelines do not constitute substantive rulemaking and hence do
not have the force and effect of law.  Rather, they are to assist Office
personnel in analyzing claimed subject matter for compliance with
substantive law. Thus, rejections must be based upon the substantive
law, and it is these rejections which are appealable, not any failure by
Office personnel to follow these guidelines.

Office personnel are to rely on these guidelines in the event of any
inconsistent treatment of issues between these guidelines and any
earlier provided guidance from the Office.

II. DETERMINE WHETHER THE CLAIMED SPECIES OR SUBGENUS WOULD HAVE BEEN
OBVIOUS TO ONE OF ORDINARY SKILL IN THE PERTINENT ART AT THE TIME THE
INVENTION WAS MADE

The patentability of a claim to a specific compound or subgenus embraced
by a prior art genus should be analyzed no differently than any other
claim for purposes of  35 U.S.C. 103. "The section 103 requirement of
unobviousness is no different in chemical cases than with respect to
other categories of patentable inventions."   In re Papesch, 315 F.2d
381, 385, 137 USPQ 43, 47 (CCPA 1963).  A determination of patentability
under  35 U.S.C. 103 should be made upon the facts of the particular
case in view of the totality of the circumstances.  See, e.g.,   In re
Dillon, 919 F.2d 688, 692-93, 16 USPQ2d 1897, 1901 (Fed. Cir. 1990) (in
banc), cert. denied, 500 U.S. 904 (1991).  Use of per se rules by Office
personnel is improper for determining whether claimed subject matter
would have been obvious under  35 U.S.C. 103.  See, e.g.,   In re
Brouwer, 77 F.3d 422, 425, 37 USPQ2d 1663, 1666 (Fed. Cir. 1996); In re
Ochiai, 71 F.3d 1565, 1572, 37 USPQ2d 1127, 1133 (Fed. Cir. 1995); In re
Baird, 16 F.3d 380, 382, 29 USPQ2d 1550, 1552 (Fed. Cir. 1994).  The
fact that a claimed species or subgenus is encompassed by a prior art
genus is not sufficient by itself to establish a prima facie case of
obviousness. In re Baird, 16 F.3d 380, 382, 29 USPQ2d 1550, 1552 (Fed.
Cir. 1994) ("The fact that a claimed compound may be encompassed by a
disclosed generic formula does not by itself render that compound
obvious."); In re Jones, 958 F.2d 347, 350, 21 USPQ2d 1941, 1943 (Fed.
Cir. 1992) (Federal Circuit has "decline[d] to extract from Merck [  &
Co. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed.
Cir. 1989)] the rule that . . . regardless of how broad, a disclosure of
a chemical genus renders obvious any species that happens to fall within
it.").  See also In re Deuel, 51 F.3d 1552, 1559, 34 USPQ2d 1210, 1215
(Fed. Cir. 1995).

A proper obviousness analysis involves a three-step process.  First,
Office personnel should establish a prima facie case of unpatentability
considering the factors set out by the Supreme Court in Graham v. John
Deere. See, e.g., In re Bell, 991 F.2d 781, 783, 26 USPQ2d 1529, 1531
(Fed. Cir. 1993) ("The PTO bears the burden of establishing a case of
prima facie obviousness.");   In re Rijckaert, 9 F.3d 1531, 1532, 28
USPQ2d 1955, 1956 (Fed. Cir. 1993); In re Oetiker, 977 F.2d 1443, 1445,
24 USPQ2d 1443, 1444 (Fed. Cir. 1992). Graham v. John Deere Co., 383
U.S. 1, 17-18 (1966), requires that to make out a case of obviousness,
one must:

(A) determine the scope and contents of the prior art;

(B) ascertain the differences between the prior art and the claims in
issue;

(C) determine the level of skill in the pertinent art; and

(D) evaluate any evidence of secondary considerations. If a prima facie
case is established, the burden shifts to applicant to come forward with
rebuttal evidence or argument to overcome the prima facie case.   See,
e.g., Bell, 991 F.2d at 783-84, 26 USPQ2d at 1531; Rijckaert, 9 F.3d at
1532, 28 USPQ2d at 1956; Oetiker, 977 F.2d at 1445, 24 USPQ2d at 1444  .
Finally, Office personnel should evaluate the totality of the facts and
all of the evidence to determine whether they still support a conclusion
that the claimed invention would have been obvious to one of ordinary
skill in the art at the time the invention was made. Id.

A. Establishing a Prima Facie Case of Obviousness

To establish a prima facie case of obviousness in a genus-species
chemical composition situation, as in any other  35 U.S.C. 103 case, it
is essential that Office personnel find some motivation or suggestion to
make the claimed invention in light of the prior art teachings.  See,
e.g., In re Brouwer, 77 F.3d 422, 425, 37 USPQ2d 1663, 1666 (Fed. Cir.
1996) ("[T]he mere possibility that one of the esters or the active
methylene group-containing compounds . . . could be modified or replaced
such that its use would lead to the specific sulfoalkylated resin
recited in claim 8 does not make the process recited in claim 8 obvious
`unless the prior art suggested the desirability of [such a]
modification' or replacement.") (quoting In re Gordon, 733 F.2d 900,
902, 221 USPQ 1125, 1127 (Fed. Cir. 1984); In re Vaeck, 947 F.2d 488,
493, 20 USPQ2d 1438, 1442 (Fed. Cir. 1991) ("[A] proper analysis under
Section  103 requires, inter alia, consideration of . . . whether the
prior art would have suggested to those of ordinary skill in the art
that they should make the claimed composition or device, or carry out
the claimed process.").  In order to find such motivation or suggestion
there should be a reasonable likelihood that the claimed invention would
have the properties disclosed by the prior art teachings.  The prior art
disclosure may be express, implicit, or inherent.  Regardless of the
type of disclosure, the prior art must provide some motivation to one of
ordinary skill in the art to make the claimed invention in order to
support a conclusion of obviousness. See, e.g., Vaeck, 947 F.2d at 493,
20 USPQ2d at 1442 (A proper obviousness analysis requires consideration
of "whether the prior art would also have revealed that in so making or
carrying out [the claimed invention], those of ordinary skill would have
a reasonable expectation of success."); In re Dow Chemical Co., 837 F.2d
469, 473, 5 USPQ2d 1529, 1531 (Fed. Cir. 1988) ("The consistent
criterion for determination of obviousness is whether the prior art
would have suggested to one of ordinary skill in the art that this
process should be carried out and would have a reasonable likelihood of
success, viewed in the light of the prior art."); Hodosh v. Block Drug
Co., 786 F.2d 1136, 1143 n.5, 229 USPQ 182, 187 n.5 (Fed. Cir.), cert.
denied, 479 U.S. 827 (1986).  These disclosed findings should be made
with a complete understanding of the first three "Graham factors."  When
evidence of secondary considerations such as unexpected results is
initially before the Office, for example in the specification, that
evidence should be considered in deciding whether there is a   prima
facie case of obviousness. The determination as to whether a prima facie
case exists should be made on the full record before the Office at the
time of the determination. Thus, Office personnel should:

(A) determine the "scope and content of the prior art";

(B) ascertain the "differences between the prior art and the claims at
issue"; and

(C) determine "the level of ordinary skill in the pertinent art." 
Graham v. John Deere, 383 U.S. 1, 17, 148 USPQ 459, 467 (1966). Accord,
e.g., In re Paulsen, 30 F.3d 1475, 1482, 31 USPQ2d 1671, 1676 (Fed. Cir.
1994).

1. Determine the Scope and Content of the Prior Art

As an initial matter, Office personnel should determine the scope and
content of the relevant prior art.  Each reference must qualify as prior
art under  35 U.S.C. 102 (e.g., Panduit Corp. v. Dennison Mfg. Co., 810
F.2d 1561, 1568, 1 USPQ2d 1593, 1597 (Fed. Cir.) cert. denied, 481 U.S.
1052 (1987) ("Before answering Graham's `content' inquiry, it must be
known whether a patent or publication is in the prior art under 35
U.S.C. Section  102.")) and should be in the field of applicant's
endeavor, or be reasonably pertinent to the particular problem with
which the inventor was concerned.  In re Oetiker, 977 F.2d 1443, 1447,
24 USPQ2d 1443, 1445 (Fed. Cir. 1992).   Accord, e.g., In re Clay, 966
F.2d 656, 658-59, 23 USPQ2d 1058, 1060 (Fed. Cir. 1992).

In the case of a prior art reference disclosing a genus, Office
personnel should make findings as to:

(A) the structure of the disclosed prior art genus and that of any
expressly described species or subgenus within the genus;

(B) any physical or chemical properties and utilities disclosed for the
genus, as well as any suggested limitations on the usefulness of the
genus, and any problems alleged to be addressed by the genus;

(C) the predictability of the technology; and

(D) the number of species encompassed by the genus taking into
consideration all of the variables possible.

2. Ascertain the Differences Between the Prior Art Genus and the Claimed
Species or Subgenus

Once a relevant prior art genus is identified, Office personnel should
compare it to the claimed species or subgenus to determine the
differences. Through this comparison, the closest disclosed species or
subgenus in the prior art reference should be identified and compared to
that claimed. Office personnel should make explicit findings on the
similarities and differences between the closest prior art reference and
the claimed species or subgenus including findings relating to
similarity of structure, chemical properties and utilities. In
Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1537, 218 USPQ 871,
877 (Fed. Cir. 1983), the Court noted that "the question under 35 U.S.C.
Section  103 is not whether the differences [between the claimed
invention and the prior art] would have been obvious" but "whether the
claimed invention as a whole would have been obvious." (emphasis in
original). 

3. Determine the Level of Skill in the Art

Office personnel should evaluate the prior art from the standpoint of
the hypothetical person having ordinary skill in the art at the time the
claimed invention was made.  See, Ryko Mfg. Co. v. Nu-Star Inc., 950
F.2d 714, 718, 21 USPQ2d 1053, 1057 (Fed. Cir. 1991) ("The importance of
resolving the level of ordinary skill in the art lies in the necessity
of maintaining objectivity in the obviousness inquiry."); Uniroyal Inc.
v. Rudkin-Wiley Corp., 837 F.2d 1044, 1050, 5 USPQ2d 1434, 1438 (Fed.
Cir.), cert. denied, 488 U.S. 825 (1988) (evidence must be viewed from
position of ordinary skill, not of an expert).  In most cases, the only
facts of record pertaining to the level of skill in the art will be
found within the prior art reference.  However, any additional evidence
presented by applicant should be evaluated.

4. Determine Whether One of Ordinary Skill in the Art Would Have Been
Motivated To Select the Claimed Species or Subgenus

In light of the findings made relating to the three Graham factors,
Office personnel should determine whether one of ordinary skill in the
relevant art would have been motivated to make the claimed invention as
a whole, i.e., to select the claimed species or subgenus from the
disclosed prior art genus.  See, e.g., Ochiai, 71 F.3d at 1569-70, 37
USPQ2d at 1131; Deuel, 51 F.3d at 1557, 34 USPQ2d at 1214 ("[A] prima
facie case of unpatentability requires that the teachings of the prior
art suggest the claimed compounds to a person of ordinary skill in the
art." (emphasis in original));   Jones, 958 F.2d at 351, 21 USPQ2d at
1943-44 (Fed. Cir. 1992); Dillon, 919 F.2d at 692, 16 USPQ2d at 1901; In
re Lalu, 747 F.2d 703, 705, 223 USPQ 1257, 1258 (Fed. Cir. 1984) ("The
prior art must provide one of ordinary skill in the art the motivation
to make the proposed molecular modifications needed to arrive at the
claimed compound.").  See also In re Kemps, 97 F.3d 1427, 1430, 40
USPQ2d 1309, 1311 (Fed. Cir. 1996) (discussing motivation to combine).
To address this key issue, Office personnel should consider all relevant
prior art teachings, focusing on the following, where present. 

(a) Consider the Size of the Genus

Consider the size of the prior art genus, bearing in mind that size
alone cannot support an obviousness rejection.  See  , e.g.  , Baird, 16
F.3d at 383, 29 USPQ2d at 1552 (observing that "it is not the mere
number of compounds in this limited class which is significant here but,
rather, the total circumstances involved"). There is no absolute
correlation between the size of the prior art genus and a conclusion of
obviousness.  Id.  Thus, the mere fact that a prior art genus contains a
small number of members does not create a per se rule of obviousness. 
Some motivation to select the claimed species or subgenus must be taught
by the prior art. See  , e.g.  , Deuel, 51 F.3d at 1558-59, 34 USPQ2d at
1215 ("No particular one of these DNAs can be obvious unless there is
something in the prior art to lead to the particular DNA and indicate
that it should be prepared.");   Baird, 16 F.3d at 382-83, 29 USPQ2d at
1552; Bell, 991 F.2d at 784, 26 USPQ2d at 1531 ("Absent anything in the
cited prior art suggesting which of the 1036 possible sequences
suggested by Rinderknecht corresponds to the IGF gene, the PTO has not
met its burden of establishing that the prior art would have suggested
the claimed sequences.").  However, a genus may be so small that it
would anticipate the claimed species or subgenus.  For example, it has
been held that a prior art genus containing only 20 compounds inherently
anticipated a claimed species within the genus because "one skilled in
[the] art would ... envisage each member" of the genus.  In re Petering,
301 F.2d 676, 681, 133 USPQ 275, 280 (CCPA 1962) (emphasis in original).
Accord In re Schaumann, 572 F.2d 312, 316, 197 USPQ 5, 9 (CCPA 1978)
(prior art genus encompassing claimed species which disclosed preference
for lower alkyl secondary amines and properties possessed by the claimed
compound constituted description of claimed compound for purposes of  35
U.S.C. 102(b)). C.f., In re Ruschig, 343 F.2d 965, 974, 145 USPQ 274,
282 (CCPA 1965) (Rejection of claimed compound in light of prior art
genus based on Petering is not appropriate where the prior art does not
disclose a small recognizable class of compounds with common
properties.).

(b) Consider the Express Teachings

If the prior art reference expressly teaches a particular reason to
select the claimed species or subgenus, Office personnel should point
out the express disclosure which would have motivated one of ordinary
skill in the art to select the claimed invention.  An express teaching
may be based on a statement in the prior art reference such as an art
recognized equivalence.  For example, see Merck & Co. v. Biocraft Labs.,
874 F.2d 804, 807, 10 USPQ2d 1843, 1846 (Fed. Cir.), cert. denied, 493
U.S. 975 (1989) (holding claims directed to diuretic compositions
comprising a specific mixture of amiloride and hydrochlorothiazide were
obvious over a prior art reference expressly teaching that amiloride was
a pyrazinoylguanidine which could be coadministered with potassium
excreting diuretic agents, including hydrochlorothiazide which was a
named example, to produce a diuretic with desirable sodium and potassium
eliminating properties). See also, In re Kemps, 97 F.3d 1427, 1430, 40
USPQ2d 1309, 1312 (Fed. Cir. 1996) (holding there is sufficient
motivation to combine teachings of prior art to achieve claimed
invention where one reference specifically refers to the other).

(c) Consider the Teachings of Structural Similarity

Consider any teachings of a "typical," "preferred," or "optimum" species
or subgenus within the disclosed genus.  If such a species or subgenus
is structurally similar to that claimed, its disclosure may motivate one
of ordinary skill in the art to choose the claimed species or subgenus
from the genus, based on the reasonable expectation that structurally
similar species usually have similar properties. See, e.g., Dillon, 919
F.2d at 693, 696, 16 USPQ2d at 1901, 1904.  See also Deuel, 51 F.3d at
1558, 34 USPQ2d at 1214 ("Structural relationships may provide the
requisite motivation or suggestion to modify known compounds to obtain
new compounds. For example, a prior art compound may suggest its
homologs because homologs often have similar properties and therefore
chemists of ordinary skill would ordinarily contemplate making them to
try to obtain compounds with improved properties."). The utility of such
properties will normally provide some motivation to make the claimed
species or subgenus.  Id. 

In making an obviousness determination, Office personnel should consider
the number of variables which must be selected or modified, and the
nature and significance of the differences between the prior art and the
claimed invention. See, e.g., In re Jones, 958 F.2d 347, 350, 21 USPQ2d
1941, 1943 (Fed. Cir. 1992) (reversing obviousness rejection of novel
dicamba salt with acyclic structure over broad prior art genus
encompassing claimed salt, where disclosed examples of genus were
dissimilar in structure, lacking an ether linkage or being cyclic); In
re Susi, 440 F.2d 442, 445, 169 USPQ 423, 425 (CCPA 1971) (the
difference from the particularly preferred subgenus of the prior art was
a hydroxyl group, a difference conceded by applicant "to be of little
importance").  In the area of biotechnology, an exemplified species may
differ from a claimed species by a conservative substitution ("the
replacement in a protein of one amino acid by another, chemically
similar, amino acid . . . [which] is generally expected to lead to
either no change or only a small change in the properties of the
protein." Dictionary of Biochemistry and Molecular Biology 97 (John
Wiley & Sons, 2d ed. 1989)).  The effect of a conservative substitution
on protein function depends on the nature of the substitution and its
location in the chain. Although at some locations a conservative
substitution may be benign, in some proteins only one amino acid is
allowed at a given position.  For example, the gain or loss of even one
methyl group can destabilize the structure if close packing is required
in the interior of domains. James Darnell et al., Molecular Cell Biology
51 (2d ed. 1990). 

The closer the physical and chemical similarities between the claimed
species or subgenus and any exemplary species or subgenus disclosed in
the prior art, the greater the expectation that the claimed subject
matter will function in an equivalent manner to the genus. See, e.g.,
Dillon, 919 F.2d at 696, 16 USPQ2d at 1904 (and cases cited therein).
Cf. Baird, 16 F.3d at 382-83, 29 USPQ2d at 1552 (disclosure of
dissimilar species can provide teaching away).

Similarly, consider any teaching or suggestion in the reference of a
preferred species or subgenus that is significantly different in
structure from the claimed species or subgenus.  Such a teaching may
weigh against selecting the claimed species or subgenus and thus against
a determination of obviousness.  Baird, 16 F.3d at 382-83, 29 USPQ2d at
1552 (reversing obviousness rejection of species in view of large size
of genus and disclosed "optimum" species which differed greatly from and
were more complex than the claimed species); Jones, 958 F.2d at 350, 21
USPQ2d at 1943 (reversing obviousness rejection of novel dicamba salt
with acyclic structure over broad prior art genus encompassing claimed
salt, where disclosed examples of genus were dissimilar in structure,
lacking an ether linkage or being cyclic).  For example, teachings of
preferred species of a complex nature within a disclosed genus may
motivate an artisan of ordinary skill to make similar complex species
and thus teach away from making simple species within the genus. Baird,
16 F.3d at 382, 29 USPQ2d at 1552.  See also   Jones, 958 F.2d at 350,
21 USPQ2d at 1943 (disclosed salts of genus held not sufficiently
similar in structure to render claimed species prima facie obvious). 

Concepts used to analyze the structural similarity of chemical compounds
in other types of chemical cases are equally useful in analyzing
genus-species cases. For example, a claimed tetra-orthoester fuel
composition was held to be obvious in light of a prior art
tri-orthoester fuel composition based on their structural and chemical
similarity and similar use as fuel additives. Dillon, 919 F.2d at
692-93, 16 USPQ2d at 1900-02. Likewise, claims to amitriptyline used as
an antidepressant were held obvious in light of the structural
similarity to imipramine, a known antidepressant prior art compound,
where both compounds were tricyclic dibenzo compounds and differed
structurally only in the replacement of the unsaturated carbon atom in
the center ring of amitriptyline with a nitrogen atom in imipramine. In
re Merck & Co., 800 F.2d 1091, 1096-97, 231 USPQ 375, 378-79 (Fed. Cir.
1986).  Similarly, a claimed protein compound having an amino acid
sequence including Met-Phe-Pro-Leu-(Asp)4-Lys-Y was held to be obvious
in light of structural similarities to the prior art.  One reference
provided motivation to create fusion proteins in the forms
X-(Asp)4-Lys-Y.  Other references taught positioning Met at the start of
the amino acid sequence and that the sequences Phe-Pro-Ile or
Leu-Pro-Leu could serve as X in the basic formula.  The known structural
similarity of Ile and Leu meant that appellants merely substituted one
element known in the art for a known equivalent. Thus, the substitution
was held to be obvious. In re Mayne, 104 F.3d 1339, 1342-43, 41 USPQ2d
1451, 1454-55 (Fed. Cir. 1997).  Other structural similarities have been
found to support a prima facie case of obviousness. See, e.g., In re
May, 574 F.2d 1082, 1093-95, 197 USPQ 601, 610-11 (CCPA 1978)
(stereoisomers); In re Wilder, 563 F.2d 457, 460, 195 USPQ 426, 429
(CCPA 1977) (adjacent homologs and structural isomers); In re Hoch, 428
F.2d 1341, 1344, 166 USPQ 406, 409 (CCPA 1970) (acid and ethyl ester);
In re Druey, 319 F.2d 237, 240, 138 USPQ 39, 41 (CCPA 1963) (omission of
methyl group from pyrazole ring). Generally, some teaching of a
structural similarity will be necessary to suggest selection of the
claimed species or subgenus. Id. 

(d) Consider the Teachings of Similar Properties or Uses

Consider the properties and utilities of the structurally similar prior
art species or subgenus.  It is the properties and utilities that
provide real world motivation for a person of ordinary skill to make
species structurally similar to those in the prior art. Dillon, 919 F.2d
at 697, 16 USPQ2d at 1905;  In re Stemniski, 444 F.2d 581, 586, 170 USPQ
343, 348 (CCPA 1971). Conversely, lack of any known useful properties
weighs against a finding of motivation to make or select a species or
subgenus.  In re Albrecht, 514 F.2d 1389, 1392, 1395-96, 185 USPQ 585,
587, 590 (CCPA 1975) (The prior art compound so irritated the skin that
it could not be regarded as useful for the disclosed anesthetic purpose,
and therefore a person skilled in the art would not have been motivated
to make related compounds.); Stemniski, 444 F.2d at 586, 170 USPQ at 348
(close structural similarity alone is not sufficient to create a prima
facie case of obviousness when the reference compounds lack utility, and
thus there is no motivation to make related compounds.).  However, the
prior art need not disclose a newly discovered property in order for
there to be a prima facie case of obviousness. Dillon, 919 F.2d at 697,
16 USPQ2d at 1904-05 (and cases cited therein). If the claimed invention
and the structurally similar prior art species share a useful property,
that will generally be sufficient to motivate an artisan of ordinary
skill to make the claimed species: e  .g., id.  For example, based on a
finding that a tri-orthoester and a tetra-orthoester behave similarly in
certain chemical reactions, it has been held that one of ordinary skill
in the relevant art would have been motivated to select either
structure.  919 F.2d at 692, 16 USPQ2d at 1900-01. In fact, similar
properties may normally be presumed when compounds are very close in
structure. Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904.  See
also In re Grabiak, 769 F.2d 729, 731, 226 USPQ 870, 871 (Fed. Cir.
1985) ("When chemical compounds have `very close' structural
similarities and similar utilities, without more a prima facie case may
be made.").  Thus, evidence of similar properties weighs in favor of a
conclusion that the claimed invention would have been obvious.  Dillon,
919 F.2d at 697-98, 16 USPQ2d at 1905;   In re Wilder, 563 F.2d 457,
461, 195 USPQ 426, 430 (CCPA 1977); In re Linter, 458 F.2d 1013, 1016,
173 USPQ 560, 562 (CCPA 1972).

(e) Consider the Predictability of the Technology

Consider the predictability of the technology. See,   e.g., Dillon, 919
F.2d at 692-97, 16 USPQ2d at 1901-05;   In re Grabiak, 769 F.2d 729,
732-33, 226 USPQ 870, 872 (Fed. Cir. 1985).  If the technology is
unpredictable, it is less likely that structurally similar species will
render a claimed species obvious because it may not be reasonable to
infer that they would share similar properties.  See, e.g.  , In re May,
574 F.2d 1082, 1094, 197 USPQ 601, 611 (CCPA 1978) (prima facie
obviousness of claimed analgesic compound based on structurally similar
prior art isomer was rebutted with evidence demonstrating that analgesia
and addiction properties could not be reliably predicted on the basis of
chemical structure); In re Schechter, 205 F.2d 185, 191, 98 USPQ 144,
150 (CCPA 1953) (unpredictability in the insecticide field, with
homologs, isomers and analogs of known effective insecticides having
proven ineffective as insecticides, was considered as a factor weighing
against a conclusion of obviousness of the claimed compounds). However,
obviousness does not require absolute predictability, only a reasonable
expectation of success, i.e., a reasonable expectation of obtaining
similar properties. See  , e.g.  , In re O'Farrell, 853 F.2d 894, 903, 7
USPQ2d 1673, 1681 (Fed. Cir. 1988).

(f) Consider Any Other Teaching To Support the Selection of the Species
or Subgenus

The categories of relevant teachings enumerated above are those most
frequently encountered in a genus-species case, but they are not
exclusive.  Office personnel should consider the totality of the
evidence in each case.  In unusual cases, there may be other relevant
teachings sufficient to support the selection of the species or subgenus
and, therefore, a conclusion of obviousness.

5. Make Express Fact-Findings and Determine Whether They Support a Prima
Facie Case of Obviousness

Based on the evidence as a whole (In re Bell, 991 F.2d 781,784, 26
USPQ2d 1529, 1531 (Fed. Cir. 1993); In re Kulling, 897 F.2d 1147, 1149,
14 USPQ2d 1056, 1057 (Fed. Cir. 1990)), Office personnel should make
express fact-findings relating to the Graham factors, focusing primarily
on the prior art teachings discussed above.  The fact-findings should
specifically articulate what teachings or suggestions in the prior art
would have motivated one of ordinary skill in the art to select the
claimed species or subgenus. Kulling, 897 F.2d at 1149, 14 USPQ2d at
1058; Panduit Corp. v. Dennison Mfg. Co., 810 F.2d 1561, 1579 n.42, 1
USQP2d 1593, 1606 n.42 (Fed. Cir.), cert. denied, 481 U.S. 1052 (1987). 
Thereafter, it should be determined whether these findings, considered
as a whole, support a prima facie case that the claimed invention would
have been obvious to one of ordinary skill in the relevant art at the
time the invention was made. 

B. Determining Whether Rebuttal Evidence Is Sufficient To Overcome the
Prima Facie Case of Obviousness

If a prima facie case of obviousness is established, the burden shifts
to the applicant to come forward with arguments and/or evidence to rebut
the prima facie case. See, e.g.,  Dillon, 919 F.2d at 692, 16 USPQ2d at
1901.  Rebuttal evidence and arguments can be presented in the
specification, In re Soni, 54 F.3d 746, 750, 34 USPQ2d 1684, 1687 (Fed.
Cir. 1995), by counsel, In re Chu, 66 F.3d 292, 299, 36 USPQ2d 1089,
1094-95 (Fed. Cir. 1995), or by way of an affidavit or declaration under 
37 CFR 1.132, e.g.,   Soni, 54 F.3d at 750, 34 USPQ2d at 1687; In re
Piasecki, 745 F.2d 1468, 1474, 223 USPQ 785, 789-90 (Fed. Cir. 1984).
However, arguments of counsel cannot take the place of factually
supported objective evidence. See, e.g., In re Huang, 100 F.3d 135,
139-40, 40 USPQ2d 1685, 1689 (Fed. Cir. 1996); In re De Blauwe, 736 F.2d
699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984).

Office personnel should consider all rebuttal arguments and evidence
presented by applicants. See, e.g., In re Soni, 54 F.3d 746, 750, 34
USPQ2d 1684, 1687 (Fed. Cir. 1995) (error not to consider evidence
presented in the specification). C.f., In re Alton, 76 F.3d 1168, 37
USPQ2d 1578 (Fed. Cir. 1996) (error not to consider factual evidence
submitted to counter a  35 U.S.C. 112 rejection); In re Beattie, 974
F.2d 1309, 1313, 24 USPQ2d 1040, 1042-43 (Fed. Cir. 1992) (Office
personnel should consider declarations from those skilled in the art
praising the claimed invention and opining that the art teaches away
from the invention.);   Piasecki, 745 F.2d at 1472, 223 USPQ at 788
("[Rebuttal evidence] may relate to any of the Graham factors including
the so-called secondary considerations."). Rebuttal evidence may include
evidence of "secondary considerations," such as "commercial success,
long felt but unsolved needs, [and] failure of others." Graham v. John
Deere Co., 383 U.S. at 17, 148 USPQ at 467. See also,   e.g.  , In re
Piasecki, 745 F.2d 1468, 1473, 223 USPQ 785, 788 (Fed. Cir. 1984)
(commercial success). Rebuttal evidence may also include evidence that
the claimed invention yields unexpectedly improved properties or
properties not present in the prior art.  Rebuttal evidence may consist
of a showing that the claimed compound possesses unexpected properties.
Dillon, 919 F.2d at 692-93, 16 USPQ2d at 1901.  A showing of unexpected
results must be based on evidence, not argument or speculation. In re
Mayne, 104 F.3d 1339, 1343-44, 41 USPQ2d 1451, 1455 (Fed. Cir. 1997)
(conclusory statements that claimed compound possesses unusually low
immune response or unexpected biological activity that is unsupported by
comparative data held insufficient to overcome prima facie case of
obviousness).Rebuttal evidence may include evidence that the claimed
invention was copied by others. See, e.g., In re GPAC, 57 F.3d 1573,
1580, 35 USPQ2d 1116, 1121 (Fed. Cir. 1995); Hybritech Inc. v.
Monoclonal Antibodies, 802 F.2d 1367, 1380, 231 USPQ 81, 90 (Fed. Cir.
1986), cert. denied, 480 U.S. 947 (1987). It may also include evidence
of the state of the art, the level of skill in the art, and the beliefs
of those skilled in the art. See, e.g., In re Oelrich, 579 F.2d 86,
91-92, 198 USPQ 210, 214 (CCPA 1978) (Expert opinions regarding the
level of skill in the art were probative of the Nonobviousness of the
claimed invention.);   Piasecki, 745 F.2d at 1471, 1473-74, 223 USPQ at
790 (Evidence of nontechnological nature is pertinent to the conclusion
of obviousness.  The declarations of those skilled in the art regarding
the need for the invention and its reception by the art were improperly
discounted by the Board.);   Beattie, 974 F.2d at 1313, 24 USPQ2d at
1042-43 (Seven declarations provided by music teachers opining that the
art teaches away from the claimed invention must be considered, but were
not probative because they did not contain facts and did not deal with
the specific prior art that was the subject of the rejection.).

Consideration of rebuttal evidence and arguments requires Office
personnel to weigh the proffered evidence and arguments. Office
personnel should avoid giving evidence no weight, except in rare
circumstances. Id. See also In re Alton, 76 F.3d 1168, 1174-75, 37
USPQ2d 1578, 1582-83 (Fed. Cir. 1996).  However, to be entitled to
substantial weight, the applicant should establish a nexus between the
rebuttal evidence and the claimed invention,   i.e., objective evidence
of nonobviousness must be attributable to the claimed invention.  The
Federal Circuit has acknowledged that applicant bears the burden of
establishing nexus, stating:

In the ex parte process of examining a patent application, however, the
PTO lacks the means or resources to gather evidence which supports or
refutes the applicant's assertion that the sales constitute commercial
success. C.f. Ex parte Remark, 15 USPQ2d 1498, 1503 ([BPAI] 1990)
(evidentiary routine of shifting burdens in civil proceedings
inappropriate in ex parte prosecution proceedings because examiner has
no available means for adducing evidence).  Consequently, the PTO must
rely upon the applicant to provide hard evidence of commercial success.

In re Huang, 100 F.3d 135, 139-40, 40 USPQ2d 1685, 1689 (Fed. Cir.
1996).  See also GPAC, 57 F.3d at 1580, 35 USPQ2d at 1121; In re
Paulsen, 30 F.3d 1475, 1482, 31 USPQ2d 1671, 1676 (Fed. Cir. 1994)
(Evidence of commercial success of articles not covered by the claims
subject to the  35 U.S.C. 103 rejection was not probative of
nonobviousness.). Additionally, the evidence must be reasonably
commensurate in scope with the claimed invention. See also, e.g.,   In
re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990);
In re Grasselli, 713 F.2d 731, 743, 218 USPQ 769, 777 (Fed. Cir. 1983).
In re Soni, 54 F.3d 746, 34 USPQ2d 1684 (Fed. Cir. 1995) does not change
this analysis. In   Soni, the Court declined to consider the Office's
argument that the evidence of nonobviousness was not commensurate in
scope with the claim because it had not been raised by the Examiner (54
F.3d at 751, 34 USPQ2d at 1688). 

When considering whether proffered evidence is commensurate in scope
with the claimed invention, Office personnel should not require the
applicant to show unexpected results over the entire range of properties
possessed by a chemical compound or composition.  See, e.g.,   In re
Chupp, 816 F.2d 643, 646, 2 USPQ2d 1437, 1439 (Fed. Cir. 1987). Evidence
that the compound or composition possesses superior and unexpected
properties in one of a spectrum of common properties can be sufficient
to rebut a prima facie case of obviousness. Id. 

For example, a showing of unexpected results for a single member of a
claimed subgenus, or a narrow portion of a claimed range would be
sufficient to rebut a   prima facie case of obviousness if a skilled
artisan "could ascertain a trend in the exemplified data that would
allow him to reasonably extend the probative value thereof." In re
Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980) (Evidence of
the unobviousness of a broad range can be proven by a narrower range
when one skilled in the art could ascertain a trend that would allow him
to reasonably extend the probative value thereof.).  But see  ,
Grasselli, 713 F.2d at 743, 218 USPQ at 778 (evidence of superior
properties for sodium containing composition insufficient to establish
the non-obviousness of broad claims for a catalyst with "an alkali
metal" where it was well known in the catalyst art that different alkali
metals were not interchangeable and applicant had shown unexpected
results only for sodium containing materials); In re Greenfield, 571
F.2d 1185, 1189, 197 USPQ 227, 230 (CCPA 1978) (evidence of superior
properties in one species insufficient to establish the nonobviousness
of a subgenus containing hundreds of compounds); In re Lindner, 457 F.2d
506, 508, 173 USPQ 356, 358 (CCPA 1972) (one test not sufficient where
there was no adequate basis for concluding the other claimed compounds
would behave the same way). However, an exemplary showing may be
sufficient to establish a reasonable correlation between the showing and
the entire scope of the claim, when viewed by a skilled artisan. See, 
e.g., Chupp, 816 F.2d at 646, 2 USPQ2d at 1439; Clemens, 622 F.2d at
1036, 206 USPQ at 296.  On the other hand, evidence of an unexpected
property may not be sufficient regardless of the scope of the showing. 
Where the claims are not limited to a particular use, and where the
prior art provides other motivation to select a particular species or
subgenus, a showing of a new use may not be sufficient to confer
patentability.  See Dillon, 919 F.2d at 692, 16 USPQ2d at 1900-01.
Accordingly, each case should be evaluated individually based on the
totality of the circumstances.

Office personnel should not evaluate rebuttal evidence for its
"knockdown" value against the prima facie case, Piasecki, 745 F.2d at
1473, 223 USPQ at 788, or summarily dismiss it as not compelling or
insufficient. If the evidence is deemed insufficient to rebut the prima
facie case of obviousness, Office personnel should specifically set
forth the facts and reasoning that justify this conclusion.

III. RECONSIDER ALL EVIDENCE AND CLEARLY COMMUNICATE FINDINGS AND
CONCLUSIONS

A determination under  35 U.S.C. 103 should rest on all the evidence and
should not be influenced by any earlier conclusion. See, e.g., Piasecki,
745 F.2d at 1472-73, 223 USPQ at 788; In re Eli Lilly & Co., 902 F.2d
943, 945, 14 USPQ2d 1741, 1743 (Fed. Cir. 1990).  Thus, once the
applicant has presented rebuttal evidence, Office personnel should
reconsider any initial obviousness determination in view of the entire
record. See, e.g., Piasecki, 745 F.2d at 1472, 223 USPQ at 788; Eli
Lilly, 902 F.2d at 945, 14 USPQ2d at 1743.  All the proposed rejections
and their bases should be reviewed to confirm their correctness.  Only
then should any rejection be imposed in an Office action. The Office
action should clearly communicate the Office's findings and conclusions,
articulating how the conclusions are supported by the findings. 

Where applicable, the findings should clearly articulate which portions
of the reference support any rejection. Explicit findings on motivation
or suggestion to select the claimed invention should also be articulated
in order to support a  35 U.S.C. 103 ground of rejection.   Dillon, 919
F.2d at 693, 16 USPQ2d at 1901; In re Mills, 916 F.2d 680, 683, 16
USPQ2d 1430, 1433 (Fed. Cir. 1990). Conclusory statements of similarity
or motivation, without any articulated rationale or evidentiary support,
do not constitute sufficient factual findings.

[GRAPHIC]

---SECTION---2144.09 Close Structural Similarity Between Chemical
Compounds (Homologs, Analogues, Isomers)

REJECTION BASED ON CLOSE STRUCTURAL SIMILARITY IS FOUNDED ON THE
EXPECTATION THAT COMPOUNDS SIMILAR IN STRUCTURE WILL HAVE SIMILAR
PROPERTIES

A prima facie case of obviousness may be made when chemical compounds
have very close structural similarities and similar utilities. "An
obviousness rejection based on similarity in chemical structure and
function entails the motivation of one skilled in the art to make a
claimed compound, in the expectation that compounds similar in structure
will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ
245, 254 (CCPA 1979). See   In re Papesch, 315 F.2d 381, 137 USPQ 43
(CCPA 1963) (discussed in more detail below) and In re Dillon, 919 F.2d
688, 16 USPQ2d 1897 (Fed. Cir. 1991) (discussed below and in MPEP
Section  2144) for an extensive review of the case law pertaining to
obviousness based on close structural similarity of chemical compounds.
See also MPEP Section  2144.08, paragraph II.A.4.(c).

HOMOLOGY AND ISOMERISM ARE FACTS WHICH MUST BE CONSIDERED WITH ALL OTHER
RELEVANT FACTS IN DETERMINING OBVIOUSNESS

Compounds which are position isomers (compounds having the same radicals
in physically different positions on the same nucleus) or homologs
(compounds differing regularly by the successive addition of the same
chemical group, e.g., by -CH2- groups) are generally of sufficiently
close structural similarity that there is a presumed expectation that
such compounds possess similar properties. In re Wilder, 563 F.2d 457,
195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ
601 (CCPA 1978) (stereoisomers prima facie obvious).

Isomers having the same empirical formula but different structures are
not necessarily considered equivalent by chemists skilled in the art and
therefore are not necessarily suggestive of each other. Ex parte Mowry,
91 USPQ 219 (Bd. App. 1950) (claimed cyclohexylstyrene not prima facie
obvious over prior art isohexylstyrene). Similarly, homologs which are
far removed from adjacent homologs may not be expected to have similar
properties. In re Mills, 281 F.2d 218, 126 USPQ 513 (CCPA 1960) (prior
art disclosure of C8 to C12 alkyl sulfates was not sufficient to render
prima facie obvious claimed C1 alkyl sulfate).

Homology and isomerism involve close structural similarity which must be
considered with all other relevant facts in determining the issue of
obviousness. In re Mills, 281 F.2d 218, 126 USPQ 513 (CCPA 1960); In re
Wiechert, 370 F.2d 927, 152 USPQ 247 (CCPA 1967). Homology should not be
automatically equated with   prima facie obviousness because the claimed
invention and the prior art must each be viewed "as a whole." In re
Langer, 465 F.2d 896, 175 USPQ 169 (CCPA 1972) (Claims to a
polymerization process using a sterically hindered amine were held
unobvious over a similar prior art process because the prior art
disclosed a large number of unhindered amines and only one sterically
hindered amine (which differed from a claimed amine by 3 carbon atoms),
and therefore the reference as a whole did not apprise the ordinary
artisan of the significance of hindered amines as a class.).

PRESENCE OF A TRUE HOMOLOGOUS OR ISOMERIC RELATIONSHIP IS NOT
CONTROLLING

Prior art structures do not have to be true homologs or isomers to
render structurally similar compounds   prima facie obvious. In re
Payne, 606 F.2d 303, 203 USPQ 245 (CCPA 1979) (Claimed and prior art
compounds were both directed to heterocyclic carbamoyloximino compounds
having pesticidal activity. The only structural difference between the
claimed and prior art compounds was that the ring structures of the
claimed compounds had two carbon atoms between two sulfur atoms whereas
the prior art ring structures had either one or three carbon atoms
between two sulfur atoms. The court held that although the prior art
compounds were not true homologs or isomers of the claimed compounds,
the similarity between the chemical structures and properties is
sufficiently close that one of ordinary skill in the art would have been
motivated to make the claimed compounds in searching for new
pesticides.). 

See also In re Mayne, 104 F.3d 1339, 41 USPQ2d 1451 (Fed. Cir. 1997)
(claimed protein was held to be obvious in light of structural
similarities to the prior art, including known structural similarity of
Ile and Len);   In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375
(Fed. Cir. 1986) (claimed and prior art compounds used in a method of
treating depression would have been expected to have similar activity
because the structural difference between the compounds involved a known
bioisosteric replacement) (see MPEP Section  2144.08, paragraph
II.A.4(c) for a more detailed discussion of the facts in the Mayne and
Merck cases); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir.
1991) (The tri-orthoester fuel compositions of the prior art and the
claimed tetra-orthoester fuel compositions would have been expected to
have similar properties based on close structural and chemical
similarity between the orthoesters and the fact that both the prior art
and applicant used the orthoesters as fuel additives.) (See MPEP Section 
2144 for a more detailed discussion of the facts in the Dillon case.).

Compare In re Grabiak, 769 F.2d 729, 226 USPQ 871 (Fed. Cir. 1985)
(substitution of a thioester group for an ester group in an herbicidal
safener compound was not suggested by the prior art); In re Bell, 991
F.2d 781, 26 USPQ2d 1529 (Fed. Cir. 1993) (The established relationship
between a nucleic acid and the protein it en codes in the genetic code
does not render a gene prima facie obvious over its corresponding
protein in the same way that closely related structures in chemistry may
create a prima facie case because there are a vast number of nucleotide
sequences that might encode for a specific protein as a result of
degeneracy in the genetic code (i.e., the fact that most amino acids are
specified by more than one nucleotide sequence or codon).); In re Deuel,
51 F.3d 1552, 1558-59, 34 USPQ2d 1210, 1215 (Fed. Cir. 1995) ("A prior
art disclosure of the amino acid sequence of a protein does not
necessarily render particular DNA molecules encoding the protein obvious
because the redundancy of the genetic code permits one to hypothesize an
enormous number of DNA sequences coding for the protein." The existence
of a general method of gene cloning in the prior art is not sufficient,
without more, to render obvious a particular cDNA molecule.).

PRESENCE OR ABSENCE OF PRIOR ART SUGGESTION OF METHOD OF MAKING A
CLAIMED COMPOUND MAY BE RELEVANT IN DETERMINING PRIMA FACIE OBVIOUSNESS

"[T]he presence-or absence-of a suitably operative, obvious process for
making a composition of matter may have an ultimate bearing on whether
that composition is obvious-or nonobvious-under  35 U.S.C. 103."  In re
Maloney, 411 F.2d 1321, 1323, 162 USPQ 98, 100 (CCPA 1969).

"[I]f the prior art of record fails to disclose or render obvious a
method for making a claimed compound, at the time the invention was
made, it may not be legally concluded that the compound itself is in the
possession of the public. In this context, we say that the absence of a
known or obvious process for making the claimed compounds overcomes a
presumption that the compounds are obvious, based on the close
relationships between their structures and those of prior art
compounds." In re Hoeksema, 399 F.2d 269, 274-75, 158 USPQ 597, 601
(CCPA 1968).

See In re Payne, 606 F.2d 303, 203 USPQ 245 (CCPA 1979) for a general
discussion of circumstances under which the prior art suggests methods
for making novel compounds which are of close structural similarity to
compounds known in the prior art.  In the biotechnology arts, the
existence of a general method of gene cloning in the prior art is not
sufficient, without more, to render obvious a particular cDNA molecule.
In re Deuel, 51 F.3d 1552, 1558, 34 USPQ2d 1210, 1215 (Fed. Cir. 1995)
("[T]he existence of a general method of isolating cDNA or DNA molecules
is essentially irrelevant to the question whether the specific molecules
themselves would have been obvious, in the absence of other prior art
that suggests the claimed DNAs."); In re Bell, 991 F.2d 781, 785, 26
USPQ2d 1529, 1532 (Fed. Cir. 1993).  However, it may be proper to apply
"methodology in rejecting product claims under  35 U.S.C. 103, depending
on the particular facts of the case, the manner and context in which
methodology applies, and the overall logic of the rejection." Ex parte
Goldgaber, 41 USPQ2d 1172, 1176 (Bd. Pat. App. & Inter. 1996).

PRESUMPTION OF OBVIOUSNESS BASED ON STRUCTURAL SIMILARITY IS OVERCOME
WHERE THERE IS NO REASONABLE EXPECTATION OF SIMILAR PROPERTIES

The presumption of obviousness based on a reference disclosing
structurally similar compounds may be overcome where there is evidence
showing there is no reasonable expectation of similar properties in
structurally similar compounds. In re May, 574 F.2d 1082, 197 USPQ 601
(CCPA 1978) (appellant produced sufficient evidence to establish a
substantial degree of unpredictability in the pertinent art area, and
thereby rebutted the presumption that structurally similar compounds
have similar properties); In re Schechter, 205 F.2d 185, 98 USPQ 144
(CCPA 1953). See also Ex parte Blattner, 2 USPQ2d 2047 (Bd. Pat. App. &
Inter. 1987) (Claims directed to compounds containing a 7-membered ring
were rejected as prima facie obvious over a reference which taught 5-
and 6-membered ring homologs of the claimed compounds. The Board
reversed the rejection because the prior art taught that the compounds
containing a 5-membered ring possessed the opposite utility of the
compounds containing the 6-membered ring, undermining the examiner's
asserted prima facie case arising from an expectation of similar results
in the claimed compounds which contain a 7-membered ring.).

IF PRIOR ART COMPOUNDS HAVE NO UTILITY, OR UTILITY ONLY AS
INTERMEDIATES, CLAIMED STRUCTURALLY SIMILAR COMPOUNDS MAY NOT BE PRIMA
FACIE OBVIOUS OVER THE PRIOR ART

If the prior art does not teach any specific or significant utility for
the disclosed compounds, then the prior art is not sufficient to render
structurally similar claims   prima facie obvious because there is no
motivation for one of ordinary skill in the art to make the reference
compounds, much less any structurally related compounds. In re
Stemniski, 444 F.2d 581, 170 USPQ 343 (CCPA 1971).

Where structurally similar "prior art compounds `cannot be regarded as
useful' for the sole use disclosed [by the reference], . . . a person
having ordinary skill in the art would lack the `necessary impetus' to
make the claimed compounds." In re Albrecht, 514 F.2d 1389, 1396,  185
USPQ 585, 590 (CCPA 1975) (prior art reference studied the local
anesthetic activity of various compounds, and taught that compounds
structurally similar to those claimed were irritating to human skin and
therefore "cannot be regarded as useful anesthetics." 514 F.2d at 1393,
185 USPQ at 587).

Similarly, if the prior art merely discloses compounds as intermediates
in the production of a final product, one of ordinary skill in the art
would not have been motivated to stop the reference synthesis and
investigate the intermediate compounds with an expectation of arriving
at claimed compounds which have different uses. In re Lalu, 747 F.2d
703, 223 USPQ 1257 (Fed. Cir. 1984).

PRIMA FACIE CASE REBUTTABLE BY EVIDENCE OF SUPERIOR OR UNEXPECTED
RESULTS

A prima facie case of obviousness based on structural similarity is
rebuttable by proof that the claimed compounds possess unexpectedly
advantageous or superior properties. In re Papesch, 315 F.2d 381, 137
USPQ 43 (CCPA 1963) (Affidavit evidence which showed that claimed
triethylated compounds possessed anti-inflammatory activity whereas
prior art trimethylated compounds did not was sufficient to overcome
obviousness rejection based on the homologous relationship between the
prior art and claimed compounds.); In re Wiechert, 370 F.2d 927, 152
USPQ 247 (CCPA 1967) (a 7-fold improvement of activity over the prior
art held sufficient to rebut prima facie obviousness based on close
structural similarity).

However, a claimed compound may be obvious because it was suggested by,
or structurally similar to, a prior art compound even though a
particular benefit of the claimed compound asserted by patentee is not
expressly disclosed in the prior art. It is the differences in fact in
their respective properties which are determinative of nonobviousness.
If the prior art compound does in fact possess a particular benefit,
even though the benefit is not recognized in the prior art, applicant's
recognition of the benefit is not in itself sufficient to distinguish
the claimed compound from the prior art. In re Dillon, 919 F.2d 688, 16
USPQ2d 1897 (Fed. Cir. 1991).

See MPEP Section  716.02 -  Section  716.02(g) for a discussion of
evidence alleging unexpectedly advantageous or superior results.

---SECTION---2145 Consideration of Applicant's Rebuttal Arguments

I. ARGUMENT DOES NOT REPLACE EVIDENCE WHERE EVIDENCE IS NECESSARY

Attorney argument is not evidence unless it is an admission, in which
case, an examiner may use the admission in making a rejection. See MPEP
Section  2129 and Section  2144.03 for a discussion of admissions as
prior art.

The arguments of counsel cannot take the place of evidence in the
record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965);
In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362  (Fed. Cir. 1997) ("An
assertion of what seems to follow from common experience is just
attorney argument and not the kind of factual evidence that is required
to rebut a prima facie case of obviousness."). See MPEP Section 
716.01(c) for examples of attorney statements which are not evidence and
which must be supported by an appropriate affidavit or declaration.

II. ARGUING ADDITIONAL ADVANTAGES OR LATENT PROPERTIES

Prima Facie Obviousness Is Not Rebutted by Merely Recognizing Additional
Advantages or Latent Properties Present in the Prior Art

Mere recognition of latent properties in the prior art does not render
nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019,
201 USPQ 658 (CCPA 1979) (Claims were directed to grooved carbon disc
brakes wherein the grooves were provided to vent steam or vapor during a
braking action. A prior art reference taught noncarbon disc brakes which
were grooved for the purpose of cooling the faces of the braking members
and eliminating dust. The court held the prior art references when
combined would overcome the problems of dust and overheating solved by
the prior art and would inherently overcome the steam or vapor cause of
the problem relied upon for patentability by applicants. Granting a
patent on the discovery of an unknown but inherent function (here
venting steam or vapor) "would remove from the public that which is in
the public domain by virtue of its inclusion in, or obviousness from,
the prior art." 596 F.2d at 1022, 201 USPQ at 661.);   In re Baxter
Travenol Labs., 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991) (Appellant
argued that the presence of DEHP as the plasticizer in a blood
collection bag unexpectedly suppressed hemolysis and therefore rebutted
any prima facie showing of obviousness, however the closest prior art
utilizing a DEHP plasticized blood collection bag inherently achieved
same result, although this fact was unknown in the prior art.).

"The fact that appellant has recognized another advantage which would
flow naturally from following the suggestion of the prior art cannot be
the basis for patentability when the differences would otherwise be
obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985)
(The prior art taught combustion fluid analyzers which used labyrinth
heaters to maintain the samples at a uniform temperature. Although
appellant showed an unexpectedly shorter response time was obtained when
a labyrinth heater was employed, the Board held this advantage would
flow naturally from following the suggestion of the prior art.). See
also   Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12
USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990)
(unpublished - not citable as precedent) ("The recitation of an
additional advantage associated with doing what the prior art suggests
does not lend patentability to an otherwise unpatentable invention.").

In re Lintner, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972) and In re Dillon,
919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990) discussed in MPEP Section 
2144 are also pertinent to this issue.

See MPEP Section  716.02 -  Section  716.02(g) for a discussion of
declaratory evidence alleging unexpected results.

III. ARGUING THAT PRIOR ART DEVICES ARE NOT PHYSICALLY COMBINABLE

"The test for obviousness is not whether the features of a secondary
reference may be bodily incorporated into the structure of the primary
reference. . . . Rather, the test is what the combined teachings of
those references would have suggested to those of ordinary skill in the
art." In re Keller, 642 F.2d 413, 425, 208 USPQ 871, 881 (CCPA 1981).
See also In re Sneed, 710 F.2d 1544, 1550, 218 USPQ 385, 389 (Fed. Cir.
1983) ("[I]t is not necessary that the inventions of the references be
physically combinable to render obvious the invention under review.");
and In re Nievelt, 482 F.2d 965, 179 USPQ 224, 226 (CCPA 1973)
("Combining the teachings of references does not involve an ability to
combine their specific structures.").

However, the claimed combination cannot change the principle of
operation of the primary reference or render the reference inoperable
for its intended purpose. See MPEP Section  2143.01.

IV. ARGUING AGAINST REFERENCES INDIVIDUALLY

One cannot show nonobviousness by attacking references individually
where the rejections are based on combinations of references. In re
Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., Inc.,
800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).

V. ARGUING ABOUT THE NUMBER OF REFERENCES COMBINED

Reliance on a large number of references in a rejection does not,
without more, weigh against the obviousness of the claimed invention. In
re Gorman, 933 F.2d 982, 18 USPQ2d 1885 (Fed. Cir. 1991) (Court affirmed
a rejection of a detailed claim to a candy sucker shaped like a thumb on
a stick based on thirteen prior art references.).

VI. ARGUING LIMITATIONS WHICH ARE NOT CLAIMED

Although the claims are interpreted in light of the specification,
limitations from the specification are not read into the claims. In re
Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993) (Claims to a
superconducting magnet which generates a "uniform magnetic field" were
not limited to the degree of magnetic field uniformity required for
Nuclear Magnetic Resonance (NMR) imaging. Although the specification
disclosed that the claimed magnet may be used in an NMR apparatus, the
claims were not so limited.); Constant v. Advanced Micro-Devices, Inc.,
848 F.2d 1560, 1571-72, 7 USPQ2d 1057, 1064-1065 (Fed. Cir.), cert.
denied, 488 U.S. 892 (1988) (Various limitations on which appellant
relied were not stated in the claims; the specification did not provide
evidence indicating these limitations must be read into the claims to
give meaning to the disputed terms.); Ex parte McCullough, 7 USPQ2d
1889, 1891 (Bd. Pat. App. & Inter. 1987) (Claimed electrode was rejected
as obvious despite assertions that electrode functions differently than
would be expected when used in nonaqueous battery since "although the
demonstrated results may be germane to the patentability of a battery
containing appellant's electrode, they are not germane to the
patentability of the invention claimed on appeal.").

See MPEP Section  2111 -  Section  2116.01, for additional case law
relevant to claim interpretation.

VII. ARGUING ECONOMIC INFEASIBILITY

The fact that a combination would not be made by businessmen for
economic reasons does not mean that a person of ordinary skill in the
art would not make the combination because of some technological
incompatibility. In re Farrenkopf, 713 F.2d 714, 219 USPQ 1 (Fed. Cir.
1983) (Prior art reference taught that addition of inhibitors to
radioimmunoassay is the most convenient, but costliest solution to
stability problem. The court held that the additional expense associated
with the addition of inhibitors would not discourage one of ordinary
skill in the art from seeking the convenience expected therefrom.).

VIII. ARGUING ABOUT THE AGE OF REFERENCES

"The mere age of the references is not persuasive of the unobviousness
of the combination of their teachings, absent evidence that,
notwithstanding knowledge of the references, the art tried and failed to
solve the problem." In re Wright, 569 F.2d 1124, 1127, 193 USPQ 332, 335
(CCPA 1977) (100 year old patent was properly relied upon in a rejection
based on a combination of references.). See also Ex parte Meyer, 6
USPQ2d 1966 (Bd. Pat. App. & Inter. 1988) (length of time between the
issuance of prior art patents relied upon (1920 and 1976) was not
persuasive of unobviousness).

IX. ARGUING THAT PRIOR ART IS NONANALOGOUS

A prior art reference is analogous if the reference is in the field of
applicant's endeavor or, if not, the reference is reasonably pertinent
to the particular problem with which the inventor was concerned. In re
Oetiker, 977 F.2d 1443, 1446, 24 USPQ2d 1443, 1445 (Fed. Cir. 1992).

See MPEP Section  2141.01(a) for case law pertaining to analogous art.

X. ARGUING IMPROPER RATIONALES FOR COMBINING REFERENCES

A. Impermissible Hindsight

Applicants may argue that the examiner's conclusion of obviousness is
based on improper hindsight reasoning. However, "[a]ny judgement on
obviousness is in a sense necessarily a reconstruction based on
hindsight reasoning, but so long as it takes into account only knowledge
which was within the level of ordinary skill in the art at the time the
claimed invention was made and does not include knowledge gleaned only
from applicant's disclosure, such a reconstruction is proper." In re
McLaughlin 443 F.2d 1392, 1395, 170 USPQ 209, 212 (CCPA 1971).

B. Obvious To Try Rationale

An applicant may argue the examiner is applying an improper "obvious to
try" rationale in support of an obviousness rejection.

"The admonition that `obvious to try' is not the standard under Section 
103 has been directed mainly at two kinds of error. In some cases, what
would have been `obvious to try' would have been to vary all parameters
or try each of numerous possible choices until one possibly arrived at a
successful result, where the prior art gave either no indication of
which parameters were critical or no direction as to which of many
possible choices is likely to be successful. . . . In others, what was
`obvious to try' was to explore a new technology or general approach
that seemed to be a promising field of experimentation, where the prior
art gave only general guidance as to the particular form of the claimed
invention or how to achieve it." In re O'Farrell, 853 F.2d 894, 903, 7
USPQ2d 1673, 1681 (Fed. Cir. 1988) (citations omitted) (The court held
the claimed method would have been obvious over the prior art relied
upon because one reference contained a detailed enabling methodology, a
suggestion to modify the prior art to produce the claimed invention, and
evidence suggesting the modification would be successful.). See the
cases cited in O'Farrell for examples of decisions where the court
discussed an improper "obvious to try" approach. See also In re Eli
Lilly & Co., 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) and In re
Ball Corp., 925 F.2d 1480, 18 USPQ2d 1491 (Fed. Cir. 1991) (unpublished)
for examples of cases where appellants argued that an improper "obvious
to try" standard was applied, but the court found that there was proper
motivation to modify the references.

C. Lack of Suggestion To Combine References

As discussed in MPEP Section  2143.01, there must be some suggestion or
motivation, either in the references themselves or in the knowledge
generally available to one of ordinary skill in the art, to modify or
combine reference teachings. The Federal Circuit has produced a number
of decisions overturning obviousness rejections due to a lack of
suggestion in the prior art of the desirability of combining references,
as discussed in the aforementioned section.

D. References Teach Away from the Invention or Render Prior Art
Unsatisfactory for Intended Purpose

In addition to the material below, see MPEP Section  2141.02 (prior art
must be considered in its entirety, including disclosures that teach
away from the claims) and MPEP Section  2143.01 (proposed modification
cannot render the prior art unsatisfactory for its intended purpose or
change the principle of operation of a reference).

1. The Nature of the Teaching Is Highly Relevant

A prior art reference that "teaches away" from the claimed invention is
a significant factor to be considered in determining obviousness;
however, "the nature of the teaching is highly relevant and must be
weighed in substance. A known or obvious composition does not become
patentable simply because it has been described as somewhat inferior to
some other product for the same use." In re Gurley, 27 F.3d 551, 554, 31
USPQ2d 1130, 1132 (Fed. Cir. 1994) (Claims were directed to an epoxy
resin based printed circuit material. A prior art reference disclosed a
polyester-imide resin based printed circuit material, and taught that
although epoxy resin based materials have acceptable stability and some
degree of flexibility, they are inferior to polyester-imide resin based
materials. The court held the claims would have been obvious over the
prior art because the reference taught epoxy resin based material was
useful for applicant's purpose, applicant did not distinguish the
claimed epoxy from the prior art epoxy, and applicant asserted no
discovery beyond what was known to the art.).

2. References Cannot Be Combined Where Reference Teaches Away from Their
Combination

It is improper to combine references where the references teach away
from their combination. In re Grasselli, 713 F.2d 731, 743, 218 USPQ
769, 779 (Fed. Cir. 1983) (The claimed catalyst which contained both
iron and an alkali metal was not suggested by the combination of a
reference which taught the interchangeability of antimony and alkali
metal with the same beneficial result, combined with a reference
expressly excluding antimony from, and adding iron to, a catalyst.).

3. Proceeding Contrary to Accepted Wisdom Is Evidence of Nonbviousness

The totality of the prior art must be considered, and proceeding
contrary to accepted wisdom in the art is evidence of nonobviousness.  
In re Hedges, 783 F.2d 1038, 228 USPQ 685 (Fed. Cir. 1986) (Applicant's
claimed process for sulfonating diphenyl sulfone at a temperature above
127&ordm;C was contrary to accepted wisdom because the prior art as a
whole suggested using lower temperatures for optimum results as
evidenced by charring, decomposition, or reduced yields at higher
temperatures.).

Furthermore, "[k]nown disadvantages in old devices which would naturally
discourage search for new inventions may be taken into account in
determining obviousness." United States v. Adams, 383 U.S. 39, 52, 148
USPQ 479, 484 (1966).

XI. FORM PARAGRAPHS

See MPEP Section  707.07 for Form Paragraphs 7.37 through 7.38 which may
be used where applicant's arguments are not persuasive or are moot.

---SECTION---2146 35 U.S.C. 103(c)

35 U.S.C. 103 Conditions of patentability; non-obvious subject matter.

                  +++    

(c) Subject matter developed by another person, which qualifies as prior
art only under subsection (f) or (g) of section 102 of this title, shall
not preclude patentability under this section where the subject matter
and the claimed invention were, at the time the invention was made,
owned by the same person or subject to an obligation of assignment to
the same person.

35 U.S.C. 103(c) provides that subject matter developed by another which
qualifies as "prior art" only under  35 U.S.C. 102(f) or (g) is not to
be considered when determining whether an invention sought to be
patented is obvious under  35 U.S.C. 103, provided the subject matter
and the claimed invention were commonly owned at the time the invention
was made. 35 U.S.C.103(c) applies only to subject matter which qualifies
as prior art under  35 U.S.C. 103; it does not affect subject matter
which qualifies as prior art under  35 U.S.C. 102, i.e., anticipatory
prior art. See MPEP Section  706.02(l) regarding Office practice with
respect to  35 U.S.C. 103(c).

---SECTION---2161 Three Separate Requirements for Specification Under 35
U.S.C. 112,  First Paragraph

THE SPECIFICATION MUST INCLUDE A WRITTEN DESCRIPTION OF THE INVENTION,
ENABLEMENT, AND BEST MODE OF CARRYING OUT THE CLAIMED INVENTION

The first paragraph of  35 U.S.C. 112 provides:

The specification shall contain a written description of the invention,
and of the manner and process of making and using it, in such full,
clear, concise, and exact terms as to   enable any person skilled in the
art to which it pertains, or with which it is most nearly connected, to
make and use the same, and shall set forth the best mode contemplated by
the inventor of carrying out his invention. (emphasis added).

This section of the statute requires that the specification include the
following:

(A) A written description of the invention;

(B) The manner and process of making and using the invention (the
enablement requirement); and

(C) The best mode contemplated by the inventor of carrying out his
invention.

THE THREE REQUIREMENTS ARE SEPARATE AND DISTINCT FROM EACH OTHER

The written description requirement is separate and distinct from the
enablement requirement. In re Barker, 559 F.2d 588, 194 USPQ 470 (CCPA
1977), cert. denied, 434 U.S. 1064 (1978); Vas-Cath, Inc. v. Mahurkar,
935 F.2d 1555, 1562, 19 USPQ2d 1111, 1115 (Fed. Cir. 1991) (While
acknowledging that some of its cases concerning the written description
requirement and the enablement requirement are confusing, the Federal
Circuit reaffirmed that under  35 U.S.C. 112, first paragraph, the
written description requirement is separate and distinct from the
enablement requirement and gave an example thereof.). An invention may
be described without the disclosure being enabling (e.g., a chemical
compound for which there is no disclosed or apparent method of making),
and a disclosure could be enabling without describing the invention
(e.g., a specification describing a method of making and using a paint
composition made of functionally defined ingredients within broad ranges
would be enabling for formulations falling within the description but
would not describe any specific formulation). See In re Armbruster, 512
F.2d 676, 677, 185 USPQ 152, 153 (CCPA 1975) ("[A] specification which
`describes' does not necessarily also `enable' one skilled in the art to
make or use the claimed invention."). Best mode is a separate and
distinct requirement from the enablement requirement. In re Newton, 414
F.2d 1400, 163 USPQ 34 (CCPA 1969).

---SECTION---2162 Policy Underlying 35 U.S.C. 112, First Paragraph

To obtain a valid patent, a patent application must be filed that
contains a full and clear disclosure of the invention in the manner
prescribed by  35 U.S.C. 112, first paragraph. The requirement for an
adequate disclosure ensures that the public receives something in return
for the exclusionary rights that are granted to the inventor by a
patent. The grant of a patent helps to foster and enhance the
development and disclosure of new ideas and the advancement of
scientific knowledge. Upon the grant of a patent in the U.S.,
information contained in the patent becomes a part of the information
available to the public for further research and development, subject
only to the patentee's right to exclude others during the life of the
patent.

In exchange for the patent rights granted,  35 U.S.C. 112, first
paragraph sets forth the minimum requirements for the quality and
quantity of information that must be contained in the patent to justify
the grant. As will be discussed in more detail below, the patentee must
disclose in the patent sufficient information to put the public in
possession of the invention and to enable those skilled in the art to
make and use the invention and must not conceal from the public the best
way of practicing the invention that was known to the patentee at the
time of filing the patent application. Failure to fully comply with the
disclosure requirements could result in the denial of a patent, or in a
holding of invalidity of an issued patent.

---SECTION---2163 The Written Description Requirement

The written description requirement has several policy objectives.
"[T]he `essential goal' of the description of the invention requirement
is to clearly convey the information that an applicant has invented the
subject matter which is claimed." In re Barker, 559 F.2d 588, 592 n.4,
194 USPQ 470, 473 n.4 (CCPA 1977), cert. denied, 434 U.S. 1064 (1978).
Another objective is to put the public in possession of what the
applicant claims as the invention so that the public may ascertain if
the patent applicant claims anything that is in common use, or already
known. Evans v. Eaton, 20 U.S. (7 Wheat.) 356 (1822).

An applicant's specification must convey with reasonable clarity to
those skilled in the art that, as of the filing date sought, he or she
was in possession of the invention, i.e., whatever is now claimed.
Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117
(Fed. Cir. 1991). The written description requirement prevents an
applicant from claiming subject matter that was not described in the
application as filed, and the proscription against the introduction of
new matter in a patent application (35 U.S.C. 132 and 251) serves to
prevent an applicant from adding to the informational content of a
patent application after it is filed.

---SECTION---2163.01 Support for the Claimed Subject Matter in
Disclosure

A written description requirement issue generally involves the question
of whether the subject matter of a claim is supported by [conforms to]
the disclosure of an application as filed. If the examiner concludes
that the claimed subject matter is not supported [described] in an
application as filed, this would result in a rejection of the claim on
the ground of a lack of written description under  35 U.S.C. 112, first
paragraph or denial of the benefit of the filing date of a previously
filed application. The claim should not be rejected or objected to on
the ground of new matter. As framed by the court in In re Rasmussen, 650
F.2d 1212, 211 USPQ 323 (CCPA 1981), the concept of new matter is
properly employed as a basis for objection to amendments to the
abstract, specification or drawings attempting to add new disclosure to
that originally presented. While the test or analysis of description
requirement and new matter issues is the same, the examining procedure
and statutory basis for addressing these issues differ. See MPEP Section 
2163.06.

---SECTION---2163.02 Standard for Determining Compliance With the
Written Description Requirement

The courts have described the essential question to be addressed in a
description requirement issue in a variety of ways. An objective
standard for determining compliance with the written description
requirement is, "does the description clearly allow persons of ordinary
skill in the art to recognize that he or she invented what is claimed."
In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir.
1989). Under Vas-Cath, Inc. v.  Mahurkar, 935 F.2d 1555, 1563-64, 19
USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description
requirement, an applicant must convey with reasonable clarity to those
skilled in the art that, as of the filing date sought, he or she was in
possession of the invention, and that the invention, in that context, is
whatever is now claimed. The test for sufficiency of support in a parent
application is whether the disclosure of the application relied upon
"reasonably conveys to the artisan that the inventor had possession at
that time of the later claimed subject matter." Ralston Purina Co. v.
Far-Mar-Co., Inc., 772 F.2d 1570, 1575, 227 USPQ 177, 179 (Fed. Cir.
1985) (quoting   In re Kaslow, 707 F.2d 1366, 1375, 217 USPQ 1089, 1096
(Fed. Cir. 1983)).

Whenever the issue arises, the fundamental factual inquiry is whether a
claim defines an invention that is clearly conveyed to those skilled in
the art at the time the application was filed. The subject matter of the
claim need not be described literally (i.e., using the same terms or in
haec verba) in order for the disclosure to satisfy the description
requirement. If a claim is amended to include subject matter,
limitations, or terminology not present in the application as filed,
involving a departure from, addition to, or deletion from the disclosure
of the application as filed, the examiner should conclude that the
claimed subject matter is not described in that application. This
conclusion will result in the rejection of the claims affected under 35
U.S.C.112, first paragraph - description requirement, or denial of the
benefit of the filing date of a previously filed application, as
appropriate.

---SECTION---2163.03 Typical Circumstances Where Adequate Written
Description Issue Arises

A description requirement issue can arise in a number of different
circumstances where it must be determined whether the subject matter of
a new or amended claim is supported in an application as filed. The
following circumstances are typical:

I. AMENDMENT AFFECTING A CLAIM

An amendment to the claims or the addition of a new claim must be
supported by the description of the invention in the application as
filed. In re Wright, 866 F.2d 422, 9 USPQ2d 1649 (Fed. Cir. 1989).
Original claims constitute their own description. In re Koller, 613 F.2d
819, 204 USPQ 702 (CCPA 1980). An amendment to the specification (e.g.,
a change in the definition of a term used both in the specification and
claim) may indirectly affect a claim even though no actual amendment is
made to the claim.

II. RELIANCE ON FILING DATE OF PARENT APPLICATION UNDER 35 U.S.C. 120

Under  35 U.S.C. 120, the claims in a U.S. application are entitled to
the benefit of the filing date of an earlier filed U.S. application if
the subject matter of the claim is disclosed in the manner provided by 
35 U.S.C. 112, first paragraph in the earlier filed application. In re
Scheiber, 587 F.2d 59, 199 USPQ 782 (CCPA 1978).

III. RELIANCE ON PRIORITY UNDER  35 U.S.C. 119

Under  35 U.S.C. 119 (a) or (e), the claims in a U.S. application are
entitled to the benefit of a foreign priority date or the filing date of
a provisional application if the corresponding foreign application or
provisional application supports the claims in the manner required by 
35 U.S.C. 112, first paragraph. In re Ziegler, 992 F.2d 1197, 1200, 26
USPQ2d 1600, 1603 (Fed. Cir. 1993);   Kawai v. Metlesics, 480 F.2d 880,
178 USPQ 158 (CCPA 1973); In re Gosteli, 872 F.2d 1008, 10 USPQ2d 1614
(Fed. Cir. 1989).

IV. SUPPORT FOR A CLAIM CORRESPONDING TO A COUNT IN AN INTERFERENCE

A broad generic disclosure to a class of compounds was not a sufficient
written description of a specific compound within the class. Fields v.
Conover, 443 F.2d 1386, 170 USPQ 276 (CCPA 1970).

---SECTION---2163.04 Burden on the Examiner With Regard to the Written
Description Requirement

The inquiry into whether the description requirement is met must be
determined on a case-by-case basis and is a question of fact. In re
Wertheim, 541 F.2d 257, 262, 191 USPQ 90, 96 (CCPA 1976). The examiner
has the initial burden of presenting evidence or reasons why persons
skilled in the art would not recognize in an applicant's disclosure a
description of the invention defined by the claims. 541 F.2d at 265, 191
USPQ at 98. See also Ex parte Sorenson, 3 USPQ2d 1462, 1463 (Bd. Pat.
App. & Inter. 1987).

I. STATEMENT OF REJECTION REQUIREMENTS

Any time an examiner bases a rejection of a claim or the denial of the
effect of a filing date of a previously filed application on the lack of
a written description, the examiner should:  (A) identify the claim
limitation not described; and (B) provide reasons why persons skilled in
the art at the time the application was filed would not have recognized
the description of this limitation in the disclosure of the application
as filed. A typical reason points out the differences between what is
disclosed and what is claimed. A simple statement that "There does not
appear to be a written description of the claim limitation `______' in
the application as filed." may be sufficient where the support is not
apparent and the applicant has not pointed out where the limitation is
supported.

II. RESPONSE TO AMENDMENTS

If applicant amends the claims and points out where and/or how the
originally filed disclosure supports the amendment(s), and the examiner
finds that the disclosure does not reasonably convey that the inventor
had possession of the subject matter of the amendment at the time of the
filing of the application, the examiner has the initial burden of
presenting evidence or reasoning to explain why persons skilled in the
art would not recognize in the disclosure a description of the invention
defined by the claims. Accordingly, the examiner should identify what
portion(s) of the amendment lack support in the originally filed
disclosure, and should fully explain the basis for the examiner's
finding. The examiner also should comment on the substance of
applicant's remarks. Any affidavits attesting to what one of ordinary
skill in the art would consider disclosed by the application as
originally filed must be thoroughly analyzed and discussed in the Office
action.

---SECTION---2163.05 Changes to the Scope of Claims

The failure to meet the written description requirement of  35 U.S.C.
112, first paragraph, commonly arises when the claims are changed after
filing to either broaden or narrow the breadth of the claim limitations,
or to alter a numerical range limitation or to use claim language which
is not synonymous with the terminology used in the original disclosure.

I. BROADENING CLAIM

In a reissue application, a claim to a display device was broadened by
removing the limitations directed to the specific tapered shape of the
tips without violating the written description requirement. The shape
limitation was considered to be unnecessary since the specification, as
filed, did not describe the tapered shape as essential or critical to
the operation or patentability of the claim. In re Peters, 723 F.2d 891,
221 USPQ 952 (Fed. Cir. 1983).

However, in   In re Wilder, 736 F.2d 1516, 222 USPQ 369 (Fed. Cir.
1984), the Federal Circuit affirmed that part of a Board of Appeals
decision rejecting reissue claims for a recording apparatus which
omitted a limitation that required indexing means to scan an array of
light emitting diodes "in synchronism" with the scanning of the record
medium by scanning means. The court held that the generic invention
represented by the reissue claims (i.e., covering scanning means and
indexing means not in synchronism) was not supported by the original
patent's disclosure in such a way as to indicate possession, as of the
original filing date, of that generic invention.

In The Gentry Gallery, Inc. v. The Berkline Corp., 134 F.3d 1473,
1479-80, 45 USPQ2d 1498, 1503 (Fed. Cir. 1998), the Federal Circuit held
claims to a sectional sofa comprising, inter alia, a console and a pair
of control means, were invalid for failing to satisfy the written
description requirement of  35 U.S.C. 112, first paragraph, where the
claims were broadened by removing language limiting the location of the
control means to the console. The court acknowledged that while a claim
may be broader than the specific embodiment disclosed in the
specification, the "claims may be no broader than the supporting
disclosure."  Thus, a narrow disclosure will limit claim breadth. Upon
reading the disclosure, the court noted, "one skilled in the art would
clearly understand that it was not only important, but essential to
[patentee's] invention, for the controls to be on the console."  The
court based this conclusion on several factors: the fact that the
disclosure provided for only the most minor variation in the location of
the controls by providing that the control "may be mounted on the top or
side surfaces of the console rather than on the front wall... without
departing from the invention;" the only discernable purpose for the
console was to house the controls; the broadest original claim limited
the location of the control means to the console; and, at trial, the
patentee admitted that he did not consider placing the controls outside
the console until he became aware that some of his competitors were so
locating the controls.

The benefit of foreign priority was denied in In re Gosteli, 872 F.2d
1008, 10 USPQ2d 1614 (Fed. Cir. 1989), because claims in the U.S.
application were not supported in the foreign priority application. In
the claims of the U.S. application, chemical compounds representing
antibiotics were generically claimed via reference to a structure with
varying moieties and were also claimed subgenerically in a Markush
format. The foreign application disclosed only 2 of the species
presented in the broad generic claim and in the 21 compounds listed in
the Markush claims. The court concluded that the additional subject
matter in the U.S. application was not adequately described in the
foreign document.

II. NARROWING OR SUBGENERIC CLAIM

The introduction of claim changes which involve narrowing the claims by
introducing elements or limitations which are not supported by the
as-filed disclosure is a violation of the written description
requirement of  35 U.S.C. 112, first paragraph. In Ex parte Ohshiro, 14
USPQ2d 1750 (Bd. Pat. App. & Inter. 1989), the Board affirmed the
rejection under  35 U.S.C. 112, first paragraph, of claims to an
internal combustion engine which recited "at least one of said piston
and said cylinder (head) having a recessed channel." The Board held that
the application which disclosed a cylinder head with a recessed channel
and a piston without a recessed channel did not specifically disclose
the "species" of a channeled piston.

While this and other cases find that recitation of an undisclosed
species may violate the description requirement, a change involving
subgeneric terminology may or may not be acceptable. Applicant was not
entitled to the benefit of a parent filing date when the claim was
directed to a subgenus (a specified range of molecular weight ratios)
where the parent application contained a generic disclosure and a
specific example that fell within the recited range because the court
held that subgenus range was not described in the parent application.  
In re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA 1971). On the other hand,
in Ex parte Sorenson, 3 USPQ2d 1462 (Bd. Pat. App. & Inter. 1987), the
subgeneric language of "aliphatic carboxylic acid" and "aryl carboxylic
acid" did not violate the written description requirement because
species falling within each subgenus were disclosed as well as the
generic carboxylic acid. See also In re Smith, 458 F.2d 1389, 1395, 173
USPQ 679, 683 (CCPA 1972) ("Whatever may be the viability of an
inductive-deductive approach to arriving at a claimed subgenus, it
cannot be said that such a subgenus is necessarily described by a genus
encompassing it and a species upon which it reads." (emphasis added)).
Each case must be decided on its own facts in terms of what is
reasonably communicated to those skilled in the art. In re Wilder, 736
F.2d 1516, 1520, 222 USPQ 369, 372 (Fed. Cir. 1984).

III. RANGE LIMITATIONS

With respect to changing numerical range limitations, the analysis must
take into account which ranges one skilled in the art would consider
inherently supported by the discussion in the original disclosure. In
the decision in In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976),
the ranges described in the original specification included a range of
"25%- 60%" and specific examples of "36%" and "50%." A corresponding new
claim limitation to "at least 35%" did not meet the description
requirement because the phrase "at least" had no upper limit and caused
the claim to read literally on embodiments outside the "25% to 60%"
range, however a limitation to "between 35% and 60%" did meet the
description requirement.

---SECTION---2163.06 Relationship of Written Description Requirement to
New Matter

Lack of written description is an issue that generally arises with
respect to the subject matter of a claim. If an applicant amends or
attempts to amend the abstract, specification or drawings of an
application, an issue of new matter will arise if the content of the
amendment is not described in the application as filed. Stated another
way, information contained in any one of the specification, claims or
drawings of the application as filed may be added to any other part of
the application without introducing new matter.

There are two statutory provisions that prohibit the introduction of new
matter:  35 U.S.C. 132 - No amendment shall introduce new matter into
the disclosure of the invention; and, similarly providing for a reissue
application,  35 U.S.C. 251 - No new matter shall be introduced into the
application for reissue.

I. TREATMENT OF NEW MATTER

The rules provide for the treatment of new matter as follows:

37 CFR 1.118 Amendment of disclosure.

(a) No amendment shall introduce new matter into the disclosure of an
application after the filing date of the application, see  37 CFR
1.53(b). All amendments to the specification, including the claims and
the drawings filed after the filing date of the application must conform
to at least one of them as it was at the time of the filing of the
application. Matter not found in either, involving a departure from or
an addition to the original disclosure, cannot be added to the
application after its filing date even though supported by an oath or
declaration in accordance with  37 CFR 1.63 or  37 CFR 1.67 filed after
the filing date of the application.

(b) If it is determined that an amendment filed after the filing date of
the application introduces new matter, claims containing new matter will
be rejected and deletion of the new matter in the specification and
drawings will be required even if the amendment is accompanied by an
oath or declaration in accordance with  37 CFR 1.63 or  37 CFR 1.67.

If new subject matter is added to the disclosure, whether it be in the
abstract, the specification, or the drawings,  the examiner should
object to the introduction of new matter under  35 U.S.C. 132 or 251 as
appropriate, and require applicant to cancel the new matter. If new
matter is added to the claims, the examiner should reject the claims
under  35 U.S.C. 112, first paragraph - written description requirement.
In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981). The examiner
should still consider the subject matter added to the claim in making
rejections based on prior art since the new matter rejection may be
overcome by applicant.

In an instance in which the claims have not been amended, per se, but
the specification has been amended to add new matter, a rejection of the
claims under  35 U.S.C. 112, first paragraph should be made whenever any
of the claim limitations are affected by the added material.

Whenever an objection or rejection is made based on  35 U.S.C. 112,
first paragraph, the examiner should in the interest of expeditious
prosecution call attention to  37 CFR 1.118.

When an amendment is filed in reply to an objection or rejection based
on  35 U.S.C. 112, first paragraph, a study of the entire application is
often necessary to determine whether or not "new matter" is involved.
Applicant should therefore specifically point out the support for any
amendments made to the disclosure.

II. REVIEW OF NEW MATTER OBJECTIONS AND/OR REJECTIONS

A rejection of claims is reviewable by the Board of Patent Appeals and
Interferences, whereas an objection and requirement to delete new matter
is subject to supervisory review by petition under  37 CFR 1.181. If
both the claims and specification contain new matter either directly or
indirectly, and there has been both a rejection and objection by the
examiner, the issue becomes appealable and should not be decided by
petition.

III. CLAIMED SUBJECT MATTER NOT DISCLOSED IN REMAINDER OF SPECIFICATION

The claims as filed in the original specification are part of the
disclosure and therefore, if an application as originally filed contains
a claim disclosing material not disclosed in the remainder of the
specification, the applicant may amend the specification to include the
claimed subject matter. In re Benno, 768 F.2d 1340, 226 USPQ 683 (Fed.
Cir. 1985). Form Paragraph 7.44 may be used where originally claimed
subject matter lacks proper antecedent basis in the specification.  See
MPEP Section  608.01(o).

---SECTION---2163.07 Amendments to Application Which Are Supported in
the Original Description

Amendments to an application which are supported in the original
description are NOT new matter.

I. REPHRASING

Mere rephrasing of a passage does not constitute new matter.
Accordingly, a rewording of a passage where the same meaning remains
intact is permissible. In re Anderson, 471 F.2d 1237, 176 USPQ 331 (CCPA
1973). The mere inclusion of dictionary or art recognized definitions
known at the time of filing an application would not be considered new
matter. If there are multiple definitions for a term and a definition is
added to the application, it must be clear from the application as filed
that applicant intended a particular definition, in order to avoid an
issue of new matter and/or lack of written description.

II. OBVIOUS ERRORS

An amendment to correct an obvious error does not constitute new matter
where one skilled in the art would not only recognize the existence of
error in the specification, but also the appropriate correction. In re
Oda, 443 F.2d 1200, 170 USPQ 260 (CCPA 1971).

Where a non-English foreign priority document under  35 U.S.C. 119 is of
record in the application file, applicant may not rely on the disclosure
of that document to support correction of an error in the pending
application. Ex parte Bondiou, 132 USPQ 356 (Bd. App. 1961). This
prohibition would apply regardless of the language of the foreign
priority documents because a claim for priority is simply a claim for
the benefit of an earlier filing date for subject matter that is common
to two or more applications, and does not serve to incorporate the
content of the priority document in the application in which the claim
for priority is made. This prohibition does not apply in a situation
where the original application is in a non-English language (37 CFR
1.52(d)), or where the original application explicitly incorporates a
non-English language document by reference.

---SECTION---2163.07(a) Inherent Function, Theory, or Advantage

By disclosing in a patent application a device that inherently performs
a function or has a property, operates according to a theory or has an
advantage, a patent application necessarily discloses that function,
theory or advantage, even though it says nothing explicit concerning it.
The application may later be amended to recite the function, theory or
advantage without introducing prohibited new matter. In re Reynolds, 443
F.2d 384, 170 USPQ 94 (CCPA 1971); In re Smythe, 480 F. 2d 1376, 178
USPQ 279 (CCPA 1973).

---SECTION---2163.07(b) Incorporation by Reference

Instead of repeating some information contained in another document, an
application may attempt to incorporate the content of another document
or part thereof by reference to the document in the text of the
specification. The information incorporated is as much a part of the
application as filed as if the text was repeated in the application, and
should be treated as part of the text of the application as filed.
Replacing the identified material incorporated by reference with the
actual text is not new matter. See MPEP Section  608.01(p) for Office
policy regarding incorporation by reference.

---SECTION---2164 The Enablement Requirement

The enablement requirement refers to the requirement of  35 U.S.C. 112,
first paragraph that the specification describe how to make and how to
use the invention. The invention that one skilled in the art must be
enabled to make and use is that defined by the claim(s) of the
particular application or patent.

The purpose of the requirement that the specification describe the
invention in such terms that one skilled in the art can make and use the
claimed invention is to ensure that the invention is communicated to the
interested public in a meaningful way. The information contained in the
disclosure of an application must be sufficient to inform those skilled
in the relevant art how to both make and use the claimed invention.
Detailed procedures for making and using the invention may not be
necessary if the description of the invention itself is sufficient to
permit those skilled in the art to make and use the invention. A patent
claim is invalid if it is not supported by an enabling disclosure.

The enablement requirement of  35 U.S.C. 112, first paragraph, is
separate and distinct from the description requirement. Vas-Cath, Inc.
v. Mahurkar, 935 F.2d 1555, 1563, 19 USPQ2d 1111, 1116-17 (Fed. Cir.
1991) ("the purpose of the `written description' requirement is broader
than to merely explain how to `make and use' ").  See also MPEP Section 
2161.  Therefore, the fact that an additional limitation to a claim may
lack descriptive support in the disclosure as originally filed does not
necessarily mean that the limitation is also not enabled.  In other
words, the statement of a new limitation in and of itself may enable one
skilled in the art to make and use the claim containing that limitation
even though that limitation may not be described in the original
disclosure.  Consequently, such limitations must be analyzed for both
enablement and description using their separate and distinct criteria.

Furthermore, when the subject matter is not in the specification portion
of the application as filed but is in the claims, the limitation in and
of itself may enable one skilled in the art to make and use the claim
containing the limitation.  When claimed subject matter is only
presented in the claims and not in the specification portion of the
application, the specification should be objected to for lacking the
requisite support for the claimed subject matter using Form Paragraph
7.44. See MPEP Section  2163.06.  This is an objection to the
specification only and enablement issues should be treated separately.

---SECTION---2164.01 Test of Enablement

Any analysis of whether a particular claim is supported by the
disclosure in an application requires a determination of whether that
disclosure, when filed, contained sufficient information regarding the
subject matter of the claims as to enable one skilled in the pertinent
art to make and use the claimed invention. The standard for determining
whether the specification meets the enablement requirement was cast in
the Supreme Court decision of Mineral Separation v. Hyde, 242 U.S. 261,
270 (1916) which postured the question: is the experimentation needed to
practice the invention undue or unreasonable?  That standard is still
the one to be applied. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400,
1404 (Fed. Cir. 1988).  Accordingly, even though the statute does not
use the term "undue experimentation," it has been interpreted to require
that the claimed invention be enabled so that any person skilled in the
art can make and use the invention without undue experimentation. In re
Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988).  See also
United States v. Telectronics, Inc., 857 F.2d 778, 785, 8 USPQ2d 1217,
1223 (Fed. Cir. 1988) ("The test of enablement is whether one reasonably
skilled in the art could make or use the invention from the disclosures
in the patent coupled with information known in the art without undue
experimentation."). A patent need not teach, and preferably omits, what
is well known in the art.  In re Buchner,  929 F.2d 660, 661, 18 USPQ2d
1331, 1332 (Fed. Cir. 1991); Hybritech,  Inc. v. Monoclonal Antibodies 
,   Inc  ., 802 F.2d 1367, 1384, 231 USPQ 81, 94 (Fed. Cir. 1986), cert.
denied, 480 U.S. 947 (1987); and Lindemann Maschinenfabrik GMBH v.
American Hoist & Derrick Co., 730 F.2d  1452, 1463,  221 USPQ 481, 489
(Fed. Cir. 1984). Determining enablement is a question of law based on
underlying factual findings. In re Vaeck, 947 F.2d 488, 495, 20 USPQ2d
1438, 1444 (Fed. Cir. 1991);  Atlas Powder Co. v. E.I. du Pont de
Nemours & Co., 750 F.2d 1569, 1576, 224 USPQ 409, 413 (Fed. Cir. 1984).

UNDUE EXPERIMENTATION

The fact that experimentation may be complex does not necessarily make
it undue, if the art typically engages in such experimentation. In re
Certain Limited-Charge Cell Culture Microcarriers, 221 USPQ 1165, 1174
(Int'l Trade Comm'n 1983),   aff'd. sub nom., Massachusetts Institute of
Technology v. A.B. Fortia, 774 F.2d 1104, 227 USPQ 428 (Fed. Cir. 1985).
See also In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404. The test of
enablement is not whether any experimentation is necessary, but whether,
if experimentation is necessary, it is undue. In re Angstadt, 537 F.2d
498, 504, 190 USPQ 214, 219 (CCPA 1976).

---SECTION---2164.01(a) Undue Experimentation Factors

There are many factors to be considered when determining whether there
is sufficient evidence to support a determination that a disclosure does
not satisfy the enablement requirement and whether any necessary
experimentation is "undue."  These factors include, but are not limited
to: 

(A) The breadth of the claims;

(B) The nature of the invention;

(C) The state of the prior art;

(D) The level of one of ordinary skill;

(E) The level of predictability in the art;

(F) The amount of direction provided by the inventor;

(G) The existence of working examples; and

(H) The quantity of experimentation needed to make or use the invention
based on the content of the disclosure. 

In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)
(reversing the PTO's determination that claims directed to methods for
detection of hepatitis B surface antigens did not satisfy the enablement
requirement).  In Wands, the court noted that there was no disagreement
as to the facts, but merely a disagreement as to the interpretation of
the data and the conclusion to be made from the facts.  In re Wands, 858
F.2d at 736-40, 8 USPQ2d at 1403-07.  The Court held that the
specification was enabling with respect to the claims at issue and found
that "there was considerable direction and guidance" in the
specification; there was "a high level of skill in the art at the time
the application was filed;" and "all of the methods needed to practice
the invention were well known."  858 F.2d at 740, 8 USPQ2d at 1406. 
After considering all the factors related to the enablement issue, the
court concluded that "it would not require undue experimentation to
obtain antibodies needed to practice the claimed invention." Id., 8
USPQ2d at 1407.

It is improper to conclude that a disclosure is not enabling based on an
analysis of only one of the above factors while ignoring one or more of
the others. The examiner's analysis must consider all the evidence
related to each of these factors, and any conclusion of nonenablement
must be based on the evidence as a whole. 858 F.2d at 737, 740, 8 USPQ2d
at 1404, 1407.

A conclusion of lack of enablement means that, based on the evidence
regarding each of the above factors, the specification, at the time the
application was filed, would not have taught one skilled in the art how
to make and/or use the full scope of the claimed invention without undue
experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513
(Fed. Cir. 1993).

The determination that "undue experimentation" would have been needed to
make and use the claimed invention is not a single, simple factual
determination.  Rather, it is a conclusion reached by weighing all the
above noted factual considerations. In re Wands, 858 F.2d at 737, 8
USPQ2d at 1404.  These factual considerations are discussed more fully
in MPEP Section  2164.08 (scope or breadth of the claims), Section 
2164.05(a) (nature of the invention and state of the prior art), Section 
2164.05(b) (level of one of ordinary skill), Section  2164.03 (level of
predictability in the art and amount of direction provided by the
inventor), Section  2164.02 (the existence of working examples) and
Section  2164.06 (quantity of experimentation needed to make or use the
invention based on the content of the disclosure).

---SECTION---2164.01(b) How to Make the Claimed Invention

As long as the specification discloses at least one method for making
and using the claimed invention that bears a reasonable correlation to
the entire scope of the claim, then the enablement requirement of  35
U.S.C. 112 is satisfied. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18,
24 (CCPA 1970).  Failure to disclose other methods by which the claimed
invention may be made does not render a claim invalid under  35 U.S.C.
112. Spectra-Physics, Inc. v. Coherent, Inc., 827 F.2d 1524, 1533, 3
USPQ2d 1737, 1743 (Fed. Cir.), cert. denied, 484 U.S. 954 (1987).

Naturally, for unstable and transitory chemical intermediates, the "how
to make" requirement does not require that the applicant teach how to
make the claimed product in stable, permanent or isolatable form. In re
Breslow, 616 F.2d 516, 521, 205 USPQ 221, 226 (CCPA 1980).

A key issue that can arise when determining whether the specification is
enabling is whether the starting materials or apparatus necessary to
make the invention are available. In the biotechnical area, this is
often true when the product or process requires a particular strain of
microorganism and when the microorganism is available only after
extensive screening.

The Court in In re Ghiron, 442 F.2d 985, 991, 169 USPQ 723, 727 (CCPA
1971), made clear that if the practice of a method requires a particular
apparatus, the application must provide a sufficient disclosure of the
apparatus if the apparatus is not readily available. The same can be
said if certain chemicals are required to make a compound or practice a
chemical process. In re Howarth, 654 F.2d 103, 105, 210 USPQ 689, 691
(CCPA 1981).

---SECTION---2164.01(c) How to Use the Claimed Invention

If a statement of utility in the specification contains within it a
connotation of how to use, and/or the art recognizes that standard modes
of administration are known and contemplated,  35 U.S.C. 112 is
satisfied. In re Johnson, 282 F.2d 370, 373, 127 USPQ 216, 219 (CCPA
1960); In re Hitchings, 342 F.2d 80, 87, 144 USPQ 637, 643 (CCPA 1965).
See also In re Brana, 51 F.2d 1560, 1566, 34 USPQ2d 1437,  1441 (Fed.
Cir. 1993).

For example, it is not necessary to specify the dosage or method of use
if it is known to one skilled in the art that such information could be
obtained without undue experimentation. If one skilled in the art, based
on knowledge of compounds having similar physiological or biological
activity, would be able to discern an appropriate dosage or method of
use without undue experimentation, this would be sufficient to satisfy 
35 U.S.C. 112, first paragraph. The applicant need not demonstrate that
the invention is completely safe. See also MPEP Section  2107.

When a compound or composition claim is limited by a particular use,
enablement of that claim should be evaluated based on that limitation.
See In re Vaeck, 947 F.2d 488, 495, 20 USPQ2d 1438, 1444 (Fed. Cir.
1991) (claiming a chimeric gene capable of being expressed in any
cyanobacterium and thus defining the claimed gene by its use).

In contrast, when a compound or composition claim is not limited by a
recited use, any enabled use that would reasonably correlate with the
entire scope of that claim is sufficient to preclude a rejection for
nonenablement based on how to use. If multiple uses for claimed
compounds or compositions are disclosed in the application, then an
enablement rejection must include an explanation, sufficiently supported
by the evidence, why the specification fails to enable each disclosed
use.  In other words, if any use is enabled when multiple uses are
disclosed, the application is enabling for the claimed invention.

---SECTION---2164.02 Working Example

Compliance with the enablement requirement of  35 U.S.C. 112, first
paragraph, does not turn on whether an example is disclosed. An example
may be "working" or "prophetic." A working example is based on work
actually performed. A prophetic example describes an embodiment of the
invention based on predicted results rather than work actually conducted
or results actually achieved.

An applicant need not have actually reduced the invention to practice
prior to filing. In Gould v. Quigg, 822 F.2d 1074, 1078, 3 USPQ 2d 1302,
1304 (Fed. Cir. 1987), as of Gould's filing date, no person had built a
light amplifier or measured a population inversion in a gas discharge.
The Court held that "The mere fact that something has not previously
been done clearly is not, in itself, a sufficient basis for rejecting
all applications purporting to disclose how to do it." 822 F.2d at 1078,
3 USPQ2d at 1304 (quoting In re Chilowsky, 229 F.2d 457, 461, 108 USPQ
321, 325 (CCPA 1956)).

The specification need not contain an example if the invention is
otherwise disclosed in such manner that one skilled in the art will be
able to practice it without an undue amount of experimentation. In re
Borkowski, 422 F.2d 904, 908, 164 USPQ 642, 645 (CCPA 1970).

Lack of a working example, however, is a factor to be considered,
especially in a case involving an unpredictable and undeveloped art. But
because only an enabling disclosure is required, applicant need not
describe all actual embodiments.

NONE OR ONE WORKING EXAMPLE

When considering the factors relating to a determination of
non-enablement, if all the other factors point toward enablement, then
the absence of working examples will not by itself render the invention
non-enabled.  In other words, lack of working examples or lack of
evidence that the claimed invention works as described should never be
the sole reason for rejecting the claimed invention on the grounds of
lack of enablement.  A single working example in the specification for a
claimed invention is enough to preclude a rejection which states that
nothing is enabled since at least that embodiment would be enabled.
However, a rejection stating that enablement is limited to a particular
scope may be appropriate.

The presence of only one working example should never be the sole reason
for rejecting claims as being broader than the enabling disclosure, even
though it is a factor to be considered along with all the other factors. 
To make a valid rejection, one must evaluate all the facts and evidence
and state why one would not expect to be able to extrapolate that one
example across the entire scope of the claims.

CORRELATION: IN VITRO/IN VIVO

The issue of "correlation" is related to the issue of the presence or
absence of working examples.  "Correlation" as used herein refers to the
relationship between in vitro or in vivo animal model assays and a
disclosed or a claimed method of use.  An in vitro or in vivo animal
model example in the specification, in effect, constitutes a "working
example" if that example "correlates" with a disclosed or claimed method
invention.  If there is no correlation, then the examples do not
constitute "working examples."  In this regard, the issue of
"correlation" is also dependent on the state of the prior art.  In other
words, if the art is such that a particular model is recognized as
correlating to a specific condition, then it should be accepted as
correlating unless the examiner has evidence that the model does not
correlate.  Even with such evidence, the examiner must weigh the
evidence for and against correlation and decide whether one skilled in
the art would accept the model as reasonably correlating to the
condition. In re Brana, 51 F.3d 1560, 1566, 34 USPQ2d 1436, 1441 (Fed.
Cir. 1995) (reversing the PTO decision based on finding that in vitro
data did not support in vivo applications).

Since the initial burden is on the examiner to give reasons for the lack
of enablement, the examiner must also give reasons for a conclusion of
lack of correlation for an in vitro or in vivo animal model example. A
rigorous or an invariable exact correlation is not required, as stated
in Cross v. Iizuka, 753 F.2d 1040, 1050, 224 USPQ 739, 747  (Fed. Cir.
1985):

[B]ased upon the relevant evidence as a whole, there is a reasonable
correlation between the disclosed in vitro utility and an in vivo
activity, and therefore a rigorous correlation is not necessary where
the disclosure of pharmacological activity is reasonable based upon the
probative evidence. (Citations omitted.)

WORKING EXAMPLES AND A CLAIMED GENUS

For a claimed genus, representative examples together with a statement
applicable to the genus as a whole will ordinarily be sufficient if one
skilled in the art (in view of level of skill, state of the art and the
information in the specification) would expect the claimed genus could
be used in that manner without undue experimentation. Proof of
enablement will be required for other members of the claimed genus only
where adequate reasons are advanced by the examiner to establish that a
person skilled in the art could not use the genus as a whole without
undue experimentation.

---SECTION---2164.03 Relationship of Predictability of the Art and the
Enablement Requirement

The amount of guidance or direction needed to enable the invention is
inversely related to the amount of knowledge in the state of the art as
well as the predictability in the art. In re Fisher, 427 F.2d 833, 839,
166 USPQ 18, 24 (CCPA 1970). The "amount of guidance or direction"
refers to that information in the application, as originally filed, that
teaches exactly how to make or use the invention.  The more that is
known in the prior art about the nature of the invention, how to make,
and how to use the invention, and the more predictable the art is, the
less information needs to be explicitly stated in the specification. In
contrast, if little is known in the prior art about the nature of the
invention and the art is unpredictable, the specification would need
more detail as to how to make and use the invention in order to be
enabling.

The "predictability or lack thereof" in the art refers to the ability of
one skilled in the art to extrapolate the disclosed or known results to
the claimed invention.  If one skilled in the art can readily anticipate
the effect of a change within the subject matter to which the claimed
invention pertains, then there is predictability in the art.  On the
other hand, if one skilled in the art cannot readily anticipate the
effect of a change within the subject matter to which that claimed
invention pertains, then there is lack of predictability in the art.
Accordingly, what is known in the art provides evidence as to the
question of predictability.  In particular, the court in In re
Marzocchi, 439 F.2d 220, 223-24, 169 USPQ 367, 369-70 (CCPA 1971),
stated:

[I]n the field of chemistry generally, there may be times when the
well-known unpredictability of chemical reactions will alone be enough
to create a reasonable doubt as to the accuracy of a particular broad
statement put forward as enabling support for a claim. This will
especially be the case where the statement is, on its face, contrary to
generally accepted scientific principles.  Most often, additional
factors, such as the teachings in pertinent references, will be
available to substantiate any doubts that the asserted scope of
objective enablement is in fact commensurate with the scope of
protection sought and to support any demands based thereon for proof. 
[Footnote omitted.]

The scope of the required enablement varies inversely with the degree of
predictability involved, but even in unpredictable arts, a disclosure of
every operable species is not required. A single embodiment may provide
broad enablement in cases involving predictable factors, such as
mechanical or electrical elements. In re Vickers, 141 F.2d 522, 526-27,
61 USPQ 122, 127 (CCPA 1944); In re Cook, 439 F.2d 730, 734, 169 USPQ
298, 301 (CCPA 1971). However, in applications directed to inventions in
arts where the results are unpredictable, the disclosure of a single
species usually does not provide an adequate basis to support generic
claims. In re Soll, 97 F.2d 623, 624, 38 USPQ 189, 191 (CCPA 1938). In
cases involving unpredictable factors, such as most chemical reactions
and physiological activity, more may be required. In re Fisher, 427 F.2d
833, 839, 166 USPQ 18, 24 (CCPA 1970) (contrasting mechanical and
electrical elements with chemical reactions and physiological activity).
See also In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed.
Cir. 1993); In re Vaeck, 947 F.2d 488, 496, 20 USPQ2d 1438, 1445 (Fed.
Cir. 1991). This is because it is not obvious from the disclosure of one
species, what other species will work.

---SECTION---2164.04 Burden on the Examiner Under the Enablement
Requirement

Before any analysis of enablement can occur, it is necessary for the
examiner to construe the claims. For terms that are not well-known in
the art, or for terms that could have more than one meaning, it is
necessary that the examiner select the definition that he/she intends to
use when examining the application, based on his/her understanding of
what applicant intends it to mean, and explicitly set forth the meaning
of the term and the scope of the claim when writing an Office action. 
See G enentech v. Wellcome Foundation, 29 F.3d 1555, 1563-64, 31 USPQ2d
1161, 1167-68 (Fed. Cir. 1994).

In order to make a rejection, the examiner has the initial burden to
establish a reasonable basis to question the enablement provided for the
claimed invention. In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510
,1513 (Fed. Cir. 1993) (examiner must provide a reasonable explanation
as to why the scope of protection provided by a claim is not adequately
enabled by the disclosure). A specification disclosure which contains a
teaching of the manner and process of making and using an invention in
terms which correspond in scope to those used in describing and defining
the subject matter sought to be patented must be taken as being in
compliance with the enablement requirement of  35 U.S.C. 112, first
paragraph, unless there is a reason to doubt the objective truth of the
statements contained therein which must be relied on for enabling
support. Assuming that sufficient reason for such doubt exists, a
rejection for failure to teach how to make and/or use will be proper on
that basis.  In re Marzocchi, 439 F.2d 220, 224, 169 USPQ  367 , 370
(CCPA 1971).  As stated by the court, "it is incumbent upon the Patent
Office, whenever a rejection on this basis is made, to explain why it
doubts the truth or accuracy of any statement in a supporting disclosure
and to back up assertions of its own with acceptable evidence or
reasoning which is inconsistent with the contested statement. Otherwise,
there would be no need for the applicant to go to the trouble and
expense of supporting his presumptively accurate disclosure." 439 F.2d
at 224, 169 USPQ at 370.

According to In re Bowen, 492 F.2d 859, 862-63, 181 USPQ 48, 51 (CCPA
1974), the minimal requirement is for the examiner to give reasons for
the uncertainty of the enablement. This standard is applicable even when
there is no evidence in the record of operability without undue
experimentation beyond the disclosed embodiments. See also In re Brana,
51 F.3d 1560, 1566, 34 USPQ2d 1436 ,1441 (Fed. Cir. 1995) (citing In re
Bundy, 642 F.2d 430, 433, 209 USPQ 48, 51 (CCPA 1981)) (discussed in
MPEP Section  2164.07 regarding the relationship of the enablement
requirement to the utility requirement of  35 U.S.C. 101).

While the analysis and conclusion of a lack of enablement are based on
the factors discussed in MPEP Section  2164.01(a) and the evidence as a
whole, it is not necessary to discuss each factor in the written
enablement rejection. The language should focus on those factors,
reasons, and evidence that lead the examiner to conclude that the
specification fails to teach how to make and use the claimed invention
without undue experimentation, or that the scope of any enablement
provided to one skilled in the art is not commensurate with the scope of
protection sought by the claims. This can be done by making specific
findings of fact, supported by the evidence, and then drawing
conclusions based on these findings of fact. For example, doubt may
arise about enablement because information is missing about one or more
essential parts or relationships between parts which one skilled in the
art could not develop without undue experimentation.  In such a case,
the examiner should specifically identify what information is missing
and why one skilled in the art could not supply the information without
undue experimentation. See MPEP Section  2164.06(a). References should
be supplied if possible to support a prima facie case of lack of
enablement, but are not always required. In re Marzocchi, 439 F.2d 220,
224, 169 USPQ 367, 370 (CCPA 1971).  However, specific technical reasons
are always required.

In accordance with the principles of compact prosecution, if an
enablement rejection is appropriate, the first Office action on the
merits should present the best case with all the relevant reasons,
issues, and evidence so that all such rejections can be withdrawn if
applicant provides appropriate convincing arguments and/or evidence in
rebuttal.  Providing the best case in the first Office action will also
allow the second Office action to be made final should applicant fail to
provide appropriate convincing arguments and/or evidence. Citing new
references and/or expanding arguments in a second Office action could
prevent that Office action from being made final.  The principles of
compact prosecution also dictate that if an enablement rejection is
appropriate and the examiner recognizes limitations that would render
the claims enabled, the examiner should note such limitations to
applicant as early in the prosecution as possible.

In other words, the examiner should always look for enabled, allowable
subject matter and communicate to applicant what that subject matter is
at the earliest point possible in the prosecution of the application.

---SECTION---2164.05 Determination of Enablement Based on Evidence As a
Whole

Once the examiner has weighed all the evidence and established a
reasonable basis to question the enablement provided for the claimed
invention, the burden falls on applicant to present persuasive
arguments, supported by suitable proofs where necessary, that one
skilled in the art would be able to make and use the claimed invention
using the application as a guide. In re Brandstadter, 484 F.2d 1395,
1406-07, 179 USPQ 286, 294 (CCPA 1973).  The evidence provided by
applicant need not be conclusive but merely convincing to one skilled in
the art. 

Applicant may submit factual affidavits under  37 CFR 1.132 or cite
references to show what one skilled in the art knew at the time of
filing the application. A declaration or affidavit is, itself, evidence
that must be considered. The weight to give a declaration or affidavit
will depend upon the amount of factual evidence the declaration or
affidavit contains to support the conclusion of enablement. In re
Buchner, 929 F.2d 660, 661, 18 USPQ2d 1331, 1332 (Fed. Cir. 1991)
("expert's opinion on the ultimate legal conclusion must be supported by
something more than a conclusory statement"); cf. In re Alton, 76 F.3d
1168, 1174, 37 USPQ2d 1578, 1583 (Fed. Cir. 1996) (declarations relating
to the written description requirement should have been considered).

Applicant should be encouraged to provide any evidence to demonstrate
that the disclosure enables the claimed invention.  In chemical and
biotechnical applications, evidence actually submitted to the FDA to
obtain approval for clinical trials may be submitted. However,
considerations made by the FDA for approving clinical trials are
different from those made by the PTO in determining whether a claim is
enabled.  See Scott v. Finney, 34 F.3d 1058, 1063, 32 USPQ2d 1115, 1120
(Fed. Cir. 1994) ("Testing for full safety and effectiveness of a
prosthetic device is more properly left to the [FDA].").  Once that
evidence is submitted, it must be weighed with all other evidence
according to the standards set forth above so as to reach a
determination as to whether the disclosure enables the claimed
invention. 

To overcome a prima facie case of lack of enablement, applicant must
demonstrate by argument and/or evidence that the disclosure, as filed,
would have enabled the claimed invention for one skilled in the art at
the time of filing.  This does not preclude applicant from providing a
declaration after the filing date which demonstrates that the claimed
invention works. However, the examiner should carefully compare the
steps, materials, and conditions used in the experiments of the
declaration with those disclosed in the application to make sure that
they are commensurate in scope; i.e., that the experiments used the
guidance in the specification as filed and what was well known to one of
skill in the art.  Such a showing also must be commensurate with the
scope of the claimed invention, i.e., must bear a reasonable correlation
to the scope of the claimed invention. 

The examiner must then weigh all the evidence before him or her,
including the specification and any new evidence supplied by applicant
with the evidence and/or sound scientific reasoning previously presented
in the rejection and decide whether the claimed invention is enabled.
The examiner should never make the determination based on personal
opinion. The determination should always be based on the weight of all
the evidence.

---SECTION---2164.05(a) Specification Must Be Enabling as of the Filing
Date

Whether the specification would have been enabling as of the filing date
involves consideration of the nature of the invention, the state of the
prior art, and the level of skill in the art.  The initial inquiry is
into the nature of the invention, i.e., the subject matter to which the
claimed invention pertains. The nature of the invention becomes the
backdrop to determine the state of the art and the level of skill
possessed by one skilled in the art.

The state of the prior art is what one skilled in the art would have
known, at the time the application was filed, about the subject matter
to which the claimed invention pertains.  The relative skill of those in
the art refers to the skill of those in the art in relation to the
subject matter to which the claimed invention pertains at the time the
application was filed.  See MPEP Section  2164.05(b).

The state of the prior art provides evidence for the degree of
predictability in the art and is related to the amount of direction or
guidance needed in the specification as filed to meet the enablement
requirement. The state of the prior art is also related to the need for
working examples in the specification.

The state of the art for a given technology is not static in time.  It
is entirely possible that a disclosure filed on January 2, 1990, would
not have been enabled.  However, if the same disclosure had been filed
on January 2, 1996, it might have enabled the claims. Therefore, the
state of the prior art must be evaluated for each application based on
its filing date.

35 U.S.C. 112 requires the specification to be enabling only to a person
"skilled in the art to which it pertains, or with which it is most
nearly connected."  In general, the pertinent art should be defined in
terms of the problem to be solved rather than in terms of the technology
area, industry, trade, etc. for which the invention is used. 

The specification need not disclose what is well-known to those skilled
in the art and preferably omits that which is well-known to those
skilled and already available to the public. In re Buchner,  929 F.2d
660, 661, 18 USPQ2d 1331, 1332 (Fed. Cir. 1991); Hybritech,  Inc. v.
Monoclonal Antibodies  ,   Inc  ., 802 F.2d 1367, 1384, 231 USPQ 81, 94
(Fed. Cir. 1986), cert. denied, 480 U.S. 947 (1987); and Lindemann
Maschinenfabrik GMBH v. American Hoist & Derrick Co., 730 F.2d  1452,
1463, 221 USPQ 481, 489 (Fed. Cir. 1984). 

The state of the art existing at the filing date of the application is
used to determine whether a particular disclosure is enabling as of the
filing date. Publications dated after the filing date providing
information publicly first disclosed after the filing date generally
cannot be used to show what was known at the time of filing.   In re
Gunn, 537 F.2d 1123, 1128, 190 USPQ 402,405-06 (CCPA 1976); In re
Budnick, 537 F.2d 535, 538, 190 USPQ 422, 424 (CCPA 1976) (In general,
if an applicant seeks to use a patent to prove the state of the art for
the purpose of the enablement requirement, the patent must have an issue
date earlier than the effective filing date of the application.). While
a later dated publication cannot supplement an insufficient disclosure
in a prior dated application to make it enabling, applicant can offer
the testimony of an expert based on the publication as evidence of the
level of skill in the art at the time the application was filed.   Gould
v. Quigg, 822 F.2d 1074, 1077, 3 USPQ2d 1302, 1304 (Fed. Cir. 1987).

In general, the examiner should not use post-filing date references to
demonstrate that the patent is non-enabling.  Exceptions to this rule
could occur if a later-dated reference provides evidence of what one
skilled in the art would have known on or before the effective filing
date of the patent application.  In re Hogan, 559 F.2d 595, 605, 194
USPQ 527, 537 (CCPA 1977).  If individuals of skill in the art state
that a particular invention is not possible years after the filing date,
that would be evidence that the disclosed invention was not possible at
the time of filing and should be considered.  In In re Wright, 999 F.2d
1557, 1562, 27 USPQ2d 1510, 1513-14 (Fed. Cir. 1993) an article
published 5 years after the filing date of the application adequately
supported the examiner's position that the physiological activity of
certain viruses was sufficiently unpredictable so that a person skilled
in the art would not have believed that the success with one virus and
one animal could be extrapolated successfully to all viruses with all
living organisms. Claims not directed to the specific virus and the
specific animal were held nonenabled.

---SECTION---2164.05(b) Specification Must Be Enabling to Persons
Skilled in the Art

The relative skill of those in the art refers to the skill of those in
the art in relation to the subject matter to which the claimed invention
pertains at the time the application was filed. Where different arts are
involved in the invention, the specification is enabling if it enables
persons skilled in each art to carry out the aspect of the invention
applicable to their specialty. In re Naquin, 398 F.2d 863, 866, 158 USPQ
317, 319 (CCPA 1968).

When an invention, in its different aspects, involves distinct arts, the
specification is enabling if it enables those skilled in each art, to
carry out the aspect proper to their specialty. "If two distinct
technologies are relevant to an invention, then the disclosure will be
adequate if a person of ordinary skill in each of the two technologies
could practice the invention from the disclosures."   Technicon
Instruments Corp. v. Alpkem Corp., 664 F. Supp. 1558, 1578, 2 USPQ2d
1729, 1742 (D. Ore. 1986), aff'd in part, vacated in part, rev'd in
part, 837 F. 2d 1097 (Fed. Cir. 1987) (unpublished opinion), appeal
after remand, 866 F. 2d 417, 9 USPQ 2d 1540 (Fed. Cir. 1989). In Ex
parte Zechnall, 194 USPQ 461 (Bd. App. 1973), the Board stated
"appellants' disclosure must be held sufficient if it would enable a
person skilled in the electronic computer art, in cooperation with a
person skilled in the fuel injection art, to make and use appellants'
invention."  194 USPQ at 461.

---SECTION---2164.06 Quantity of Experimentation

The quantity of experimentation needed to be performed by one skilled in
the art is only one factor involved in determining whether "undue
experimentation" is required to make and use the invention.  "[A]n
extended period of experimentation may not be undue if the skilled
artisan is given sufficient direction or guidance."  In re Colianni, 561
F.2d 220, 224, 195 USPQ 150, 153 (CCPA 1977).  " `The test is not merely
quantitative, since a considerable amount of experimentation is
permissible, if it is merely routine, or if the specification in
question provides a reasonable amount of guidance with respect to the
direction in which the experimentation should proceed.' '' In re Wands,
858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) (citing In re
Angstadt, 537 F.2d 489, 502-04, 190 USPQ 214, 217-19 (CCPA 1976)).  Time
and expense are merely factors in this consideration and are not the
controlling factors. United States v. Telectronics Inc., 857 F.2d 778,
785, 8 USPQ2d 1217, 1223 (Fed. Cir. 1988), cert. denied, 490 U.S. 1046
(1989).

In the chemical arts, the guidance and ease in carrying out an assay to
achieve the claimed objectives may be an issue to be considered in
determining the quantity of experimentation needed. For example, if a
very difficult and time consuming assay is needed to identify a compound
within the scope of a claim, then this great quantity of experimentation
should be considered in the overall analysis. Time and difficulty of
experiments are not determinative if they are merely routine. Quantity
of examples is only one factor that must be considered before reaching
the final conclusion that undue experimentation would be required. In re
Wands, 858 F.2d at 737, 8 USPQ2d at 1404.

I. EXAMPLE OF REASONABLE EXPERIMENTATION

In United States v. Telectronics, Inc., 857  F.2d 778, 8 USPQ2d 1217
(Fed. Cir. 1988), cert. denied, 490 U.S. 1046 (1989), the court reversed
the findings of the district court for lack of clear and convincing
proof that undue experimentation was needed. The court ruled that since
one embodiment (stainless steel electrodes) and the method to determine
dose/response was set forth in the specification, the specification was
enabling. The question of time and expense of such studies,
approximately $50,000 and 6-12 months standing alone, failed to show
undue experimentation.

II. EXAMPLE OF UNREASONABLE EXPERIMENTATION

In In re Ghiron, 442 F.2d 985, 991-92, 169 USPQ 723, 727-28 (CCPA 1971),
functional "block diagrams" were insufficient to enable a person skilled
in the art to practice the claimed invention with only a reasonable
degree of experimentation because the claimed invention required a
"modification to prior art overlap computers," and because "many of the
components which appellants illustrate as rectangles in their drawing
necessarily are themselves complex assemblages . . . .  It is common
knowledge that many months or years elapse from the announcement of a
new computer by a manufacturer before the first prototype is available. 
This does not bespeak of a routine operation but of extensive
experimentation and development work . . . ."

---SECTION---2164.06(a) Examples of Enablement Issues-Missing
Information

It is common that doubt arises about enablement because information is
missing about one or more essential parts or relationships between parts
which one skilled in the art could not develop without undue
experimentation. In such a case, the examiner should specifically
identify what information is missing and why the missing information is
needed to provide enablement.

I. ELECTRICAL AND MECHANICAL DEVICES OR PROCESSES

For example, a disclosure of an electrical circuit apparatus, depicted
in the drawings by block diagrams with functional labels, was held to be
nonenabling in In re Gunn, 537 F.2d 1123, 1129, 190 USPQ 402, 406 (CCPA
1976). There was no indication in the specification as to whether the
parts represented by boxes were "off the shelf" or must be specifically
constructed or modified for applicant's system. Also there were no
details in the specification of how the parts should be interconnected,
timed and controlled so as to obtain the specific operations desired by
the applicant. In In re Donohue, 550 F.2d 1269, 193 USPQ 136 (CCPA
1977), the lack of enablement was caused by lack of information in the
specification about a single block labelled "LOGIC" in the drawings.

In re Ghiron, 442 F.2d 985, 169 USPQ 723 (CCPA 1971), involved a method
of facilitating transfers from one subset of program instructions to
another which required modification of prior art "overlap mode"
computers. The Board rejected the claims on the basis,   inter alia,
that the disclosure was insufficient to satisfy the requirements of  35
U.S.C. 112, first paragraph and was affirmed. The Board focused on the
fact that the drawings were "block diagrams, i.e., a group of rectangles
representing the elements of the system, functionally labelled and
interconnected by lines." 442 F.2d at 991, 169 USPQ at 727. The
specification did not particularly identify each of the elements
represented by the blocks or the relationship therebetween, nor did it
specify particular apparatus intended to carry out each function. The
Board further questioned whether the selection and assembly of the
required components could be carried out routinely by persons of
ordinary skill in the art.

An adequate disclosure of a device may require details of how complex
components are constructed and perform the desired function. The claim
before the court in In re Scarbrough, 500 F.2d 560, 182 USPQ 298 (CCPA
1974) was directed to a system which comprised several component parts
(e.g., computer, timing and control mechanism, A/D converter, etc.) only
by generic name and overall ultimate function. The court concluded that
there was not an enabling disclosure because the specification did not
describe how "complex elements known to perform broadly recited
functions in different systems would be adaptable for use in Appellant's
particular system with only a reasonable amount of experimentation" and
that "an unreasonable amount of work would be required to arrive at the
detailed relationships appellant says that he has solved." 500 F.2d at
566, 182 USPQ at 302.

II. MICROORGANISMS

Patent applications involving living biological products, such as
microorganisms, as critical elements in the process of making the
invention, present a unique question with regard to availability. The
issue was raised in a case involving claims drawn to a fermentative
method of producing two novel antibiotics using a specific microorganism
and claims to the novel antibiotics so produced. In re Argoudelis, 434
F.2d 1390, 168 USPQ 99 (CCPA 1970). As stated by the court, "a unique
aspect of using microorganisms as starting materials is that a
sufficient description of how to obtain the microorganism from nature
cannot be given." 434 F.2d at 1392, 168 USPQ at 102. It was determined
by the court that availability of the biological product via a public
depository provided an acceptable means of meeting the written
description and the enablement requirements of  35 U.S.C. 112, first
paragraph.

To satisfy the enablement requirement a deposit must be made "prior to
issue" but need not be made prior to filing the application. In re
Lundak, 773 F.2d 1216, 1223, 227 USPQ 90, 95 (Fed. Cir. 1985).

The availability requirement of enablement must also be considered in
light of the scope or breadth of the claim limitations. The Board of
Appeals considered this issue in an application which claimed a
fermentative method using microorganisms belonging to a species.
Applicants had identified three novel individual strains of
microorganisms that were related in such a way as to establish a new
species of microorganism, a species being a broader classification than
a strain. The three specific strains had been appropriately deposited.
The issue focused on whether the specification enabled one skilled in
the art to make any member of the species other than the three strains
which had been deposited. The Board concluded that the verbal
description of the species was inadequate to allow a skilled artisan to
make any and all members of the claimed species. Ex parte Jackson, 217
USPQ 804, 806 (Bd. App. 1982).

See MPEP Section  2402 -  Section  2411.03 for a detailed discussion of
the deposit rules. See MPEP Section  2411.01 for rejections under  35
U.S.C. 112 based on deposit issues.

III. DRUG CASES

See MPEP Section  2107 -  Section  2107.02 for a discussion of the
utility requirement under  35 U.S.C. 112, first paragraph, in drug
cases.

---SECTION---2164.06(b) Examples of Enablement Issues - Chemical Cases

The following summaries should not be relied on to support a case of
lack of enablement without carefully reading the case.

SEVERAL DECISIONS RULING THAT THE DISCLOSURE WAS NONENABLING

(A) In In re Wright, 999 F.2d 1557, 27 USPQ2d 1510 (Fed. Cir. 1993), the
1983 application disclosed a vaccine against the RNA tumor virus known
as Prague Avian Sarcoma Virus, a member of the Rous Associated Virus
family.  Using functional language, Wright claimed a vaccine "comprising
an immunologically effective amount" of a viral expression product. Id.,
at 1559, 27 USPQ2d at 1511.  Rejected claims covered all RNA viruses as
well as avian RNA viruses. The examiner provided a teaching that in
1988, a vaccine for another retrovirus (i.e., AIDS) remained an
intractable problem. This evidence, along with evidence that the RNA
viruses were a diverse and complicated genus, convinced the Federal
Circuit that the invention was not enabled for either all retroviruses
or even for avian retroviruses.

(B) In In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993), a
1985 application functionally claimed a method of producing protein in
plant cells by expressing a foreign gene. The court stated:
"[n]aturally, the specification must teach those of skill in the art
`how to make and use the invention as broadly as it is claimed.'" Id. at
1050, 29 USPQ2d at 2013.  Although protein expression in dicotyledonous
plant cells was enabled, the claims covered any plant cell.  The
examiner provided evidence that even as late as 1987, use of the claimed
method in monocot plant cells was not enabled. Id. at 1051, 29 USPQ2d at
2014.

(C) In   In re Vaeck, 947 F.2d 488, 495, 20 USPQ2d 1438, 1444 (Fed. Cir.
1991), the court found that several claims were not supported by an
enabling disclosure "[t]aking into account the relatively incomplete
understanding of the biology of cyanobacteria as of appellants' filing
date, as well as the limited disclosure by appellants of the particular
cyanobacterial genera operative in the claimed invention...."  The
claims at issue were not limited to any particular genus or species of
cyanobacteria and the specification mentioned nine genera and the
working examples employed one species of cyanobacteria.

(D) In   In re Colianni, 561 F.2d 220, 222-23, 195 USPQ 150, 152 (CCPA
1977), the court affirmed a rejection under  35 U.S.C. 112, first
paragraph, because the specification, which was directed to a method of
mending a fractured bone by applying "sufficient" ultrasonic energy to
the bone, did not define a "sufficient" dosage or teach one of ordinary
skill how to select the appropriate intensity, frequency, or duration of
the ultrasonic energy.

SEVERAL DECISIONS RULING THAT THE DISCLOSURE WAS ENABLING

(A) In PPG Ind. v. Guardian Ind., 75 F.3d 1558, 1564, 37 USPQ2d 1618,
1623 (Fed. Cir. 1996), the court ruled that even though there was a
software error in calculating the ultraviolet transmittance data for
examples in the specification making it appear that the production of a
cerium oxide-free glass that satisfied the transmittance limitation
would be difficult, the specification indicated that such glass could be
made.  The specification was found to indicate how to minimize the
cerium content while maintaining low ultraviolet transmittance.

(B) In In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988), the
court reversed the rejection for lack of enablement under  35 U.S.C.
112, first paragraph, concluding that undue experimentation would not be
required to practice the invention. The nature of monoclonal antibody
technology is such that experiments first involve the entire attempt to
make monoclonal hybridomas to determine which ones secrete antibody with
the desired characteristics. The court found that the specification
provided considerable direction and guidance on how to practice the
claimed invention and presented working examples, that all of the
methods needed to practice the invention were well known, and that there
was a high level of skill in the art at the time the application was
filed. Furthermore, the applicant carried out the entire procedure for
making a monoclonal antibody against HBsAg three times and each time was
successful in producing at least one antibody which fell within the
scope of the claims.

(C) In In re Bundy, 642  F.2d 430, 434, 209 USPQ 48, 51-52 (CCPA 1981),
the court ruled that appellant's disclosure was sufficient to enable one
skilled in the art to use the claimed analogs of naturally occurring
prostaglandins even though the specification lacked any examples of
specific dosages, because the specification taught that the novel
prostaglandins had certain pharmacological properties and possessed
activity similar to known E-type prostaglandins.

---SECTION---2164.07 Relationship of Enablement Requirement to Utility
Requirement of 35 U.S.C. 101

The requirement of  35 U.S.C. 112, first paragraph as to how to use the
invention is different from the utility requirement of  35 U.S.C. 101.
The requirement of  35 U.S.C. 101 is that some use be set forth for the
invention, and that the use be provable and not against public policy.
On the other hand,  35 U.S.C. 112, first paragraph requires an
indication of how the use (required by section 101) can be carried out,
i.e., how the invention can be used.

If an applicant has disclosed a specific utility for an invention and
provided a credible basis supporting that specific utility, that fact
alone does not provide a basis for concluding that the claims comply
with all the requirements of  35 U.S.C. 112, first paragraph. For
example, if an applicant has claimed a process of treating a certain
disease condition with a certain compound and provided a credible basis
for asserting that the compound is useful in that regard, but to
actually practice the invention as claimed a person skilled in the
relevant art would have to engage in an undue amount of experimentation,
the claim may be defective under  35 U.S.C. 112, but not  35 U.S.C. 101.
To avoid confusion during examination, any rejection under  35 U.S.C.
112, first paragraph, based on grounds other than "lack of utility"
should be imposed separately from any rejection imposed due to "lack of
utility" under  35 U.S.C. 101 and  35 U.S.C. 112, first paragraph.

I. WHEN UTILITY REQUIREMENT IS NOT SATISFIED

A. Not Useful or Operative

If a claim fails to meet the utility requirement of  35 U.S.C. 101
because it is shown to be nonuseful or inoperative, then it necessarily
fails to meet the how-to-use aspect of the enablement requirement of  35
U.S.C. 112, first paragraph. As noted in In re Fouche, 439 F.2d 1237,
169 USPQ 429 (CCPA 1971), if "compositions are in fact useless,
appellant's specification cannot have taught how to use them." 439 F.2d
at 1243, 169 USPQ at 434. The examiner should make both rejections
(i.e., a rejection under  35 U.S.C. 112, first paragraph and a rejection
under  35 U.S.C. 101) where the subject matter of a claim has been shown
to be nonuseful or inoperative.

The  35 U.S.C. 112, first paragraph, rejection should indicate that
because the invention as claimed does not have utility, a person skilled
in the art would not be able to use the invention as claimed, and as
such, the claim is defective under  35 U.S.C. 112, first paragraph. A 
35 U.S.C. 112, first paragraph, rejection should not be imposed or
maintained unless an appropriate basis exists for imposing a rejection
under  35 U.S.C. 101. In other words, Office personnel should not impose
a  35 U.S.C. 112, first paragraph, rejection grounded on a "lack of
utility" basis unless a  35 U.S.C. 101 rejection is proper. In
particular, the factual showing needed to impose a rejection under  35
U.S.C. 101 must be provided if a  35 U.S.C. 112, first paragraph,
rejection is to be imposed on "lack of utility" grounds. See MPEP
Section  706.03(a)(1) and Section  2107 -  Section  2107.02 for a more
detailed discussion of the utility requirements of  35 U.S.C. 101 and
112, first paragraph.

B. Burden on the Examiner

When the examiner concludes that an application is describing an
invention that is nonuseful, inoperative, or contradicts known
scientific principles, the burden is on the examiner to provide a
reasonable basis to support this conclusion. Rejections based on  35
U.S.C. 112, first paragraph and  35 U.S.C. 101 should be made.

Examiner Has Initial Burden To Show That One of Ordinary Skill in the
Art Would Reasonably Doubt the Asserted Utility

The examiner has the initial burden of challenging an asserted utility.
Only after the examiner has provided evidence showing that one of
ordinary skill in the art would reasonably doubt the asserted utility
does the burden shift to the applicant to provide rebuttal evidence
sufficient to convince one of ordinary skill in the art of the
invention's asserted utility. In re Brana, 51 F.3d 1560, 1566, 34 USPQ2d
1436, 1441 (Fed. Cir. 1995) (citing In re Bundy, 642 F.2d 430, 433, 209
USPQ 48, 51 (CCPA 1981)).

C. Rebuttal by Applicant

If a rejection under  35 U.S.C. 101 has been properly imposed, along
with a corresponding rejection under  35 U.S.C. 112, first paragraph,
the burden shifts to the applicant to rebut the prima facie showing. In
re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992). 
There is no predetermined amount or character of evidence that must be
provided by an applicant to support an asserted utility.  Rather, the
character and amount of evidence needed to support an asserted utility
will vary depending on what is claimed (Ex parte Ferguson, 117 USPQ 229,
231 (Bd. App. 1957)), and whether the asserted utility appears to
contravene established scientific principles and beliefs. In re Gazave,
379 F.2d 973, 978, 154 USPQ 92, 96 (CCPA 1967  ); In re Chilowsky, 229
F.2d 457, 462, 108 USPQ 321, 325 (CCPA 1956). Furthermore, the applicant
does not have to provide evidence sufficient to establish that an
asserted utility is true "beyond a reasonable doubt." In re Irons, 340
F.2d 974, 978, 144 USPQ 351, 354 (CCPA 1965). Instead, evidence will be
sufficient if, considered as a whole, it leads a person of ordinary
skill in the art to conclude that the asserted utility is more likely
than not true.  See MPEP Section  2107.01 for a more detailed discussion
of consideration of a reply to a prima facie rejection for lack of
utility and evaluation of evidence related to utility.

II. WHEN UTILITY REQUIREMENT IS SATISFIED

In some instances, the use will be provided, but the skilled artisan
will not know how to effect that use. In such a case, no rejection will
be made under  35 U.S.C. 101, but a rejection will be made under  35
U.S.C. 112, first paragraph. As pointed out in Mowry v. Whitney, 81 U.S.
(14 Wall.) 620 (1871), an invention may in fact have great utility,
i.e., may be "a highly useful invention," but the specification may
still fail to "enable any person skilled in the art or science" to use
the invention, 81 U.S. (14 Wall.) at 644.

---SECTION---2164.08 Enablement Commensurate in Scope With the Claims

All questions of enablement are evaluated against the claimed subject
matter.  The focus of the examination inquiry is whether everything
within the scope of the claim is enabled.  Accordingly, the first
analytical step requires that the examiner determine exactly what
subject matter is encompassed by the claims. The examiner should
determine what each claim recites and what the subject matter is when
the claim is considered as a whole, not when its parts are analyzed
individually.  No claim should be overlooked. With respect to dependent
claims,  35 U.S.C. 112,  fourth paragraph, should be followed.  This
paragraph states that "a claim in a dependent form shall be construed to
incorporate by reference all the limitations of the claim to which it
refers" and requires the dependent claim to further limit the subject
matter claimed.

The Federal Circuit has repeatedly held that "the specification must
teach those skilled in the art how to make and use the full scope of the
claimed invention without `undue experimentation'." In re Wright, 999
F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).  Nevertheless,
not everything necessary to practice the invention need be disclosed. 
In fact, what is well-known is best omitted. In re Buchner, 929 F.2d
660, 661, 18 USPQ2d 1331, 1332 (Fed. Cir. 1991).  All that is necessary
is that one skilled in the art be able to practice the claimed
invention, given the level of knowledge and skill in the art. Further
the scope of enablement must only bear a "reasonable correlation" to the
scope of the claims.  See, e.g., In re Fisher,  427 F.2d 833, 839, 166
USPQ 18, 24 (CCPA 1970).

As concerns the breadth of a claim relevant to enablement, the only
relevant concern should be whether the scope of enablement provided to
one skilled in the art by the disclosure is commensurate with the scope
of protection sought by the claims. In re Moore, 439 F.2d 1232, 1236,
169 USPQ 236, 239 (CCPA 1971).

The determination of the propriety of a rejection based upon the scope
of a claim relative to the scope of the enablement involves two stages
of inquiry. The first is to determine how broad the claim is with
respect to the disclosure. The entire claim must be considered. The
second inquiry is to determine if one skilled in the art is enabled to
make and use the entire scope of the claimed invention without undue
experimentation.

How a teaching is set forth, by specific example or broad terminology,
is not important. In re Marzocchi, 439 F.2d 220, 223-24 169 USPQ 367 ,
370 (CCPA 1971). A rejection of a claim under  35 U.S.C. 112 as broader
than the enabling disclosure is a first paragraph enablement rejection
and not a second paragraph definiteness rejection. Claims are not
rejected as broader than the enabling disclosure under  35 U.S.C. 112
for noninclusion of limitations dealing with factors which must be
presumed to be within the level of ordinary skill in the art; the claims
need not recite such factors where one of ordinary skill in the art to
whom the specification and claims are directed would consider them
obvious.   In re Skrivan, 427 F.2d 801, 806, 166 USPQ 85, 88 (CCPA
1970).  One does not look to the claims but to the specification to find
out how to practice the claimed invention. W.L. Gore & Assoc., Inc. v.
Garlock, Inc., 721 F.2d 1540, 1558, 220 USPQ 303, 316-17 (Fed. Cir.
1983); In re Johnson, 558 F.2d 1008, 1017, 194 USPQ 187, 195 (CCPA
1977).  In In re Goffe, 542 F.2d 564, 567, 191 USPQ 429, 431 (CCPA
1976), the court stated:

[T]o provide effective incentives, claims must adequately protect
inventors.  To demand that the first to disclose shall limit his claims
to what he has found will work or to materials which meet the guidelines
specified for "preferred" materials in a process such as the one herein
involved would not serve the constitutional purpose of promoting
progress in the useful arts.

When analyzing the enabled scope of a claim, the teachings of the
specification must not be ignored because claims are to be given their
broadest reasonable interpretation that is consistent with the
specification.  "That claims are interpreted in light of the
specification does not mean that everything in the specification must be
read into the claims." Raytheon Co. v. Roper Corp., 724 F.2d 951, 957,
220 USPQ 592, 597 (Fed. Cir. 1983), cert. denied, 469 U.S. 835 (1984).    

The record must be clear so that the public will have notice as to the
patentee's scope of protection when the patent issues.  If a reasonable
interpretation of the claim is broader than the description in the
specification, it is necessary for the examiner to make sure the full
scope of the claim is enabled. Limitations and examples in the
specification do not generally limit what is covered by the claims.

The breadth of the claims was a factor considered in Amgen v. Chugai
Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir.), cert.
denied, 502 U.S. 856 (1991).  In the Amgen case, the patent claims were
directed to a purified DNA sequence encoding polypeptides which are
analogs of erythropoietin (EPO). The Court stated that:

Amgen has not enabled preparation of DNA sequences sufficient to support
its all-encompassing claims. . . . [D]espite extensive statements in the
specification concerning all the analogs of the EPO gene that can be
made, there is little enabling disclosure of particular analogs and how
to make them.  Details for preparing only a few EPO analog genes are
disclosed. . . .  This disclosure might well justify a generic claim
encompassing these and similar analogs, but it represents inadequate
support for Amgen's desire to claim all EPO gene analogs.  There may be
many other genetic sequences that code for EPO-type products.  Amgen has
told how to make and use only a few of them and is therefore not
entitled to claim all of them.

 927 F.2d at 1213-14, 18 USPQ2d at 1027.  However, when claims are
directed to any purified and isolated DNA sequence encoding a
specifically named protein where the protein has a specifically
identified sequence, a rejection of the claims as broader than the
enabling disclosure is generally not appropriate because one skilled in
the art could readily determine any one of the claimed embodiments.

See also In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed.
Cir. 1993) (The evidence did not show that a skilled artisan would have
been able to carry out the steps required to practice the full scope of
claims which encompass "  any and all live, non-pathogenic vaccines, and
processes for making such vaccines, which elicit immunoprotective
activity in any animal toward any RNA virus." (original emphasis)); In
re Goodman,  11 F.3d 1046, 1052, 29 USPQ2d  2010, 2015 (Fed. Cir. 1993)
(The specification did not enable the broad scope of the claims for
producing mammalian peptides in plant cells because the specification
contained only an example of producing gamma-interferon in a dicot
species, and there was evidence that extensive experimentation would
have been required for encoding mammalian peptide into a monocot plant
at the time of filing); In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24
(CCPA 1970) (Where applicant claimed a composition suitable for the
treatment of arthritis having a potency of "at least" a particular
value, the court held that the claim was not commensurate in scope with
the enabling disclosure because the disclosure was not enabling for
compositions having a slightly higher potency.  Simply because applicant
was the first to achieve a composition beyond a particular threshold
potency did not justify or support a claim that would dominate every
composition that exceeded that threshold value.); In re Vaeck, 947 F.2d
488, 495, 20 USPQ2d 1438, 1444 (Fed. Cir. 1991) (Given the relatively
incomplete understanding in the biotechnological field involved, and the
lack of a reasonable correlation between the narrow disclosure in the
specification and the broad scope of protection sought in the claims, a
rejection under  35 U.S.C. 112, first paragraph for lack of enablement
was appropriate.).

If a rejection is made based on the view that the enablement is not
commensurate in scope with the claim, the examiner should identify the
subject matter that is considered to be enabled.

---SECTION---2164.08(a) Single Means Claim

A single means claim, i.e., where a means recitation does not appear in
combination with another recited element of means, is subject to an
undue breadth rejection under  35 U.S.C. 112, first paragraph. In re
Hyatt, 708 F.2d 712, 714-715, 218 USPQ 195, 197 (Fed. Cir. 1983) (A
single means claim which covered every conceivable means for achieving
the stated purpose was held nonenabling for the scope of the claim
because the specification disclosed at most only those means known to
the inventor.). When claims depend on a recited property, a fact
situation comparable to Hyatt is possible, where the claim covers every
conceivable structure (means) for achieving the stated property (result)
while the specification discloses at most only those known to the
inventor.

---SECTION---2164.08(b) Inoperative Subject Matter

The presence of inoperative embodiments within the scope of a claim does
not necessarily render a claim nonenabled. The standard is whether a
skilled person could determine which embodiments that were conceived,
but not yet made, would be inoperative or operative with expenditure of
no more effort than is normally required in the art. Atlas Powder Co. v.
E.I. du Pont de Nemours & Co., 750 F.2d 1569, 1577, 224 USPQ 409, 414
(Fed. Cir. 1984) (prophetic examples do not make the disclosure
nonenabling).

Although, typically, inoperative embodiments are excluded by language in
a claim (e.g., preamble), the scope of the claim may still not be
enabled where undue experimentation is involved in determining those
embodiments that are operable. A disclosure of a large number of
operable embodiments and the identification of a single inoperative
embodiment did not render a claim broader than the enabled scope because
undue experimentation was not involved in determining those embodiments
that were operable. In re Angstadt, 537 F.2d 498, 502-503, 190 USPQ 214,
218 (CCPA 1976). However, claims reading on significant numbers of
inoperative embodiments would render claims nonenabled when the
specification does not clearly identify the operative embodiments and
undue experimentation is involved in determining those that are
operative. Atlas Powder Co. v. E.I. duPont de Nemours & Co., 750 F.2d
1569, 1577, 224 USPQ 409, 414 (Fed. Cir. 1984); In re Cook, 439 F.2d
730, 735, 169 USPQ 298, 302 (CCPA 1971).

---SECTION---2164.08(c) Critical Feature Not Claimed 

A feature which is taught as critical in a specification and is not
recited in the claims should result in a rejection of such claim under
the enablement provision section of  35 U.S.C. 112. See In re Mayhew,
527 F.2d 1229, 1233, 188 USPQ 356, 358 (CCPA 1976). In determining
whether an unclaimed feature is critical, the entire disclosure must be
considered. Features which are merely preferred are not to be considered
critical. In re Goffe, 542 F.2d 564, 567, 191 USPQ 429, 431 (CCPA 1976).

Limiting an applicant to the preferred materials in the absence of
limiting prior art would not serve the constitutional purpose of
promoting the progress in the useful arts. Therefore, an enablement
rejection based on the grounds that a disclosed critical limitation is
missing from a claim should be made only when the language of the
specification makes it clear that the limitation is critical for the
invention to function as intended.  Broad language in the disclosure,
including the abstract, omitting an allegedly critical feature, tends to
rebut the argument of criticality.

---SECTION---2165 The Best Mode Requirement

A third requirement of the first paragraph of  35 U.S.C. 112 is that:

The specification . . . shall set forth the best mode contemplated by
the inventor of carrying out his invention.

The best mode requirement is a safeguard against the desire on the part
of some people to obtain patent protection without making a full
disclosure as required by the statute. The requirement does not permit
inventors to disclose only what they know to be their second-best
embodiment, while retaining the best for themselves. In re Nelson, 280
F.2d 172, 126 USPQ 242 (CCPA 1960).

The failure to disclose a better method will not invalidate a patent if
the inventor, at the time of filing the application, did not know of the
better method OR did not appreciate that it was the best method. All
applicants are required to disclose for the claimed subject matter the
best mode contemplated by the inventor even though applicant may not
have been the discoverer of that mode. Benger Labs. Ltd. v. R.K. Laros
Co., 209 F. Supp. 639, 135 USPQ 11 (E.D. Pa. 1962).

ACTIVE CONCEALMENT OR GROSSLY INEQUITABLE CONDUCT IS NOT REQUIRED TO
ESTABLISH FAILURE TO DISCLOSE THE BEST MODE

Failure to disclose the best mode need not rise to the level of active
concealment or grossly inequitable conduct in order to support a
rejection or invalidate a patent. Where an inventor knows of a specific
material that will make possible the successful reproduction of the
effects claimed by the patent, but does not disclose it, speaking
instead in terms of broad categories, the best mode requirement has not
been satisfied. Union Carbide Corp. v. Borg-Warner, 550 F.2d 555, 193
USPQ 1 (6th Cir. 1977).

If the failure to set forth the best mode in a patent disclosure is the
result of inequitable conduct (e.g., where the patent specification
omitted crucial ingredients and disclosed a fictitious and inoperable
slurry as Example 1), not only is that patent in danger of being held
unenforceable, but other patents dealing with the same technology that
are sought to be enforced in the same cause of action are subject to
being held unenforceable. Consolidated Aluminum Corp. v. Foseco Inc.,
910 F.2d 804, 15 USPQ2d 1481 (Fed. Cir. 1990).

---SECTION---2165.01 Considerations Relevant to Best Mode

I. DETERMINE WHAT IS THE INVENTION

Determine what the invention is - the invention is defined in the
claims. The specification need not set forth details not relating to the
essence of the invention. In re Bosy, 360 F.2d 972, 149 USPQ 789 (CCPA
1966).

II. SPECIFIC EXAMPLE IS NOT REQUIRED

There is no statutory requirement for the disclosure of a specific
example - a patent specification is not intended nor required to be a
production specification. In re Gay, 309 F.2d 768, 135 USPQ 311 (CCPA
1962).

The absence of a specific working example is not necessarily evidence
that the best mode has not been disclosed, nor is the presence of one
evidence that it has. Best mode may be represented by a preferred range
of conditions or group of reactants. In re Honn, 364 F.2d 454, 150 USPQ
652 (CCPA 1966).

III. DESIGNATION AS BEST MODE IS NOT REQUIRED

There is no requirement in the statute that applicants point out which
of their embodiments they consider to be their best; that the disclosure
includes the best mode contemplated by applicants is enough to satisfy
the statute. Ernsthausen v. Nakayama, 1 USPQ2d 1539 (Bd. Pat. App. &
Inter. 1985).

IV. UPDATING BEST MODE IS NOT REQUIRED

There is no requirement to update in the context of a foreign priority
application under  35 U.S.C. 119,   Standard Oil Co. v. Montedison,
S.p.A., 494 F.Supp. 370, 206 USPQ 676 (D.Del. 1980) (better catalyst
developed between Italian priority and U.S. filing dates), and
continuing applications claiming the benefit of an earlier filing date
under  35 U.S.C. 120, Transco Products, Inc. v. Performance Contracting
Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994) (continuation under 
37 CFR 1.60); Sylgab Steel and Wire Corp. v. Imoco-Gateway Corp., 357
F.Supp. 657, 178 USPQ 22 (N.D. Ill. 1973) (continuation); Johns-Manville
Corp. v. Guardian Industries Corp., 586 F.Supp. 1034, 221 USPQ 319 (E.D.
Mich. 1983) (continuation and C-I-P). In the last cited case, the court
stated that applicant would have been obliged to disclose an updated
refinement if it were essential to the successful practice of the
invention and it related to amendments to the C-I-P that were not
present in the parent application. In Carter-Wallace, Inc. v. Riverton
Labs., Inc., 433 F.2d 1034, 167 USPQ 656 (2d Cir. 1970), the court
assumed, but did not decide, that an applicant must update the best mode
when filing a C-I-P application.

V. DEFECT IN BEST MODE CANNOT BE CURED BY NEW MATTER

If the best mode contemplated by the inventor at the time of filing the
application is not disclosed, such a defect cannot be cured by
submitting an amendment seeking to put into the specification something
required to be there when the patent application was originally filed.
In re Hay, 534 F.2d 917, 189 USPQ 790 (CCPA 1976).

Any proposed amendment of this type (adding a specific mode of
practicing the invention not described in the application as filed)
should be treated as new matter. New matter under  35 U.S.C. 132 and 251
should be objected to and coupled with a requirement to cancel the new
matter.

---SECTION---2165.02 Best Mode Requirement Compared to Enablement
Requirement

The best mode requirement is a separate and distinct requirement from
the enablement requirement of the first paragraph of  35 U.S.C. 112. In
re Newton, 414 F.2d 1400, 163 USPQ 34 (CCPA 1969).

The best mode provision of  35 U.S.C. 112 is not directed to a situation
where the application fails to set forth any mode - such failure is
equivalent to nonenablement. In re Glass, 492 F.2d 1228, 181 USPQ 31
(CCPA 1974).

The enablement requirement looks to placing the subject matter of the
claims generally in the possession of the public. If, however, the
applicant develops specific instrumentalities or techniques which are
recognized by the applicant at the time of filing as the best way of
carrying out the invention, then the best mode requirement imposes an
obligation to disclose that information to the public as well.
Spectra-Physics, Inc. v. Coherent, Inc., 827 F.2d 1524, 3 USPQ 2d 1737
(Fed. Cir.), cert. denied, 484 U.S. 954 (1987).

---SECTION---2165.03 Requirements for Rejection for Lack of Best Mode

ASSUME BEST MODE IS DISCLOSED UNLESS THERE IS EVIDENCE TO THE CONTRARY

The examiner should assume that the best mode is disclosed in the
application, unless evidence is presented that is inconsistent with that
assumption. It is extremely rare that a best mode rejection properly
would be made in ex parte prosecution. The information that is necessary
to form the basis for a rejection based on the failure to set forth the
best mode is rarely accessible to the examiner, but is generally
uncovered during discovery procedures in interference, litigation, or
other inter partes proceedings.

EXAMINER MUST DETERMINE WHETHER THE INVENTOR KNEW THAT ONE MODE WAS
BETTER THAN ANOTHER, AND IF SO, WHETHER THE DISCLOSURE IS ADEQUATE TO
ENABLE ONE OF ORDINARY SKILL IN THE ART TO PRACTICE THE BEST MODE

According to the approach used by the court in Chemcast Corp. v. Arco
Industries, 913 F.2d 923, 16 USPQ2d 1033 (Fed. Cir. 1990), a proper best
mode analysis has two components:

(A) Determine whether, at the time the application was filed, the
inventor knew of a mode of practicing the claimed invention that the
inventor considered to be better than any other.

The first component is a subjective inquiry because it focuses on the
inventor's state of mind at the time the application was filed. Unless
the examiner has evidence that the inventors had information in their
possession

(1) at the time the application was filed

(2) that a mode was considered to be better than any others by the
inventors

there is no reason to address the second component and there is no
proper basis for a best mode rejection. If the facts satisfy the first
component, then, and only then, is the following second component
analyzed:

(B) Compare what was known in (A) with what was disclosed - is the
disclosure adequate to enable one skilled in the art to practice the
best mode?

Assessing the adequacy of the disclosure in this regard is largely an
objective inquiry that depends on the level of skill in the art. Is the
information contained in the specification disclosure sufficient to
enable a person skilled in the relevant art to make and use the best
mode?

A best mode rejection is proper only when the first inquiry can be
answered in the affirmative, and the second inquiry answered in the
negative with reasons to support the conclusion that the specification
is nonenabling with respect to the best mode.

---SECTION---2165.04 Examples of Evidence of Concealment

In determining the adequacy of a best mode disclosure, only evidence of
concealment (accidental or intentional) is to be considered. That
evidence must tend to show that the quality of an applicant's best mode
disclosure is so poor as to effectively result in concealment.

I. EXAMPLES - BEST MODE REQUIREMENT SATISFIED

In one case, even though the inventor had more information in his
possession concerning the contemplated best mode than was disclosed (a
known computer program) the specification was held to delineate the best
mode in a manner sufficient to require only the application of routine
skill to produce a workable digital computer program. In re Sherwood,
613 F.2d 809, 204 USPQ 537 (CCPA 1980).

In another case, the claimed subject matter was a time controlled
thermostat, but the application did not disclose the specific
Quartzmatic motor which was used in a commercial embodiment. The Court
concluded that failure to disclose the commercial motor did not amount
to concealment since similar clock motors were widely available and
widely advertised. There was no evidence that the specific Quartzmatic
motor was superior except possibly in price. Honeywell v. Diamond, 208
USPQ 452 (D.D.C. 1980).

There was held to be no violation of the best mode requirement even
though the inventor did not disclose the only mode of calculating the
stretch rate for plastic rods that he used because that mode would have
been employed by those of ordinary skill in the art at the time the
application was filed. W.L. Gore & Assoc., Inc. v. Garlock Inc., 721
F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983).

There was no best mode violation where there was no evidence that the
monoclonal antibodies used by the inventors differed from those
obtainable according to the processes described in the specification. It
was not disputed that the inventors obtained the antibodies used in the
invention by following the procedures in the specification, that these
were the inventors' preferred procedures, and that the data reported in
the specification was for the antibody that the inventors had actually
used. Scripps Clinic and Research Foundation v. Genentech, Inc., 927
F.2d 1565, 18 USPQ 2d 1001 (Fed. Cir. 1991).

Where an organism was created by the insertion of genetic material into
a cell obtained from generally available sources, all that was required
to satisfy the best mode requirement was an adequate description of the
means for carrying out the invention, not deposit of the cells. As to
the observation that no scientist could ever duplicate exactly the cell
used by applicants, the court observed that the issue is whether the
disclosure is adequate, not that an exact duplication is necessary. 
Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ 2d 1016
(Fed. Cir. 1991).

There was held to be no violation of the best mode requirement where the
Solicitor argued that concealment could be inferred from the disclosure
in a specification that each analog is "surprisingly and unexpectedly
more useful than one of the corresponding prostaglandins . . . for at
least one of the pharmacological purposes." It was argued that appellant
must have had test results to substantiate this statement and this data
should have been disclosed. The court concluded that no withholding
could be inferred from general statements of increased selectivity and
narrower spectrum of potency for these novel analogs, conclusions which
could be drawn from the elementary pharmacological testing of the
analogs.  In re Bundy, 642 F.2d 430, 435, 209 USPQ 48, 52 (CCPA 1981).

II. EXAMPLES - BEST MODE REQUIREMENT NOT SATISFIED

The best mode requirement was held to be violated where inventors of a
laser failed to disclose details of their preferred TiCuSil brazing
method which were not contained in the prior art and were contrary to
criteria for the use of TiCuSil as contained in the literature.  
Spectra-Physics, Inc. v. Coherent, Inc., 827 F.2d 1524, 3 USPQ 2d 1737
(Fed. Cir. 1987).

The best mode requirement was violated because an inventor failed to
disclose whether to use a specific surface treatment that he knew was
necessary to the satisfactory performance of his invention, even though
how to perform the treatment itself was known in the art. The argument
that the best mode requirement may be met solely by reference to what
was known in the prior art was rejected as incorrect. Dana Corp. v. IPC
Ltd. Partnership, 860 F.2d 415, 8 USPQ2d 1692 (Fed. Cir. 1988).

---SECTION---2171 Two Separate Requirements for Claims Under 35 U.S.C.
112, Second Paragraph

The second paragraph of  35 U.S.C. 112 is directed to requirements for
the claims:

The specification shall conclude with one or more claims particularly
pointing out and distinctly claiming the subject matter which the
applicant regards as his invention.

There are two separate requirements set forth in this paragraph:

(A) the claims must set forth the subject matter that applicants regard
as their invention; and

(B) the claims must particularly point out and distinctly define the
metes and bounds of the subject matter that will be protected by the
patent grant.

The first requirement is a subjective one because it is dependent on
what the applicants for a patent regard as their invention. The second
requirement is an objective one because it is not dependent on the views
of applicant or any particular individual, but is evaluated in the
context of whether the claim is definite - i.e., whether the scope of
the claim is clear to a hypothetical person possessing the ordinary
level of skill in the pertinent art.

Although an essential purpose of the examination process is to determine
whether or not the claims define an invention that is both novel and
nonobvious over the prior art, another essential purpose of patent
examination is to determine whether or not the claims are precise,
clear, correct, and unambiguous. The uncertainties of claim scope should
be removed, as much as possible, during the examination process.

The inquiry during examination is patentability of the invention as
applicant regards it. If the claims do not particularly point out and
distinctly claim that which applicants regard as their invention, the
appropriate action by the examiner is to reject the claims under  35
U.S.C. 112, second paragraph. In re Zletz, 893 F.2d 319, 13 USPQ2d 1320
(Fed. Cir. 1989). If a rejection is based on  35 U.S.C. 112, second
paragraph, the examiner should further explain whether the rejection is
based on indefiniteness or on the failure to claim what applicants
regard as their invention. Ex parte Ionescu, 222 USPQ 537, 539 (Bd. App.
1984).

---SECTION---2172 Subject Matter Which Applicants Regard as Their
Invention

I. FOCUS FOR EXAMINATION

A rejection based on the failure to satisfy this requirement is
appropriate only where applicant has stated, somewhere other than in the
application as filed, that the invention is something different from
what is de fined by the claims. In other words, the invention set forth
in the claims must be presumed, in the absence of evidence to the
contrary, to be that which applicants regard as their invention. In re
Moore, 439 F.2d 1232, 169 USPQ 236 (CCPA 1971).

II. EVIDENCE TO THE CONTRARY

Evidence that shows that a claim does not correspond in scope with that
which applicant regards as applicant's invention may be found, for
example, in contentions or admissions contained in briefs or remarks
filed by applicant, In re Prater, 415 F.2d 1393, 162 USPQ 541 (CCPA
1969), or in affidavits filed under  37 CFR 1.132, In re Cormany, 476
F.2d 998, 177 USPQ 450 (CCPA 1973). The content of applicant's
specification is not used as evidence that the scope of the claims is
inconsistent with the subject matter which applicants regard as their
invention. As noted in In re Ehrreich, 590 F.2d 902, 200 USPQ 504 (CCPA
1979), agreement, or lack thereof, between the claims and the
specification is properly considered only with respect to  35 U.S.C.
112, first paragraph; it is irrelevant to compliance with the second
paragraph of that section.

III. SHIFT IN CLAIMS PERMITTED

The second paragraph of  35 U.S.C. 112 does not prohibit applicants from
changing what they regard as their invention during the pendency of the
application. In re Saunders, 444 F.2d 599, 170 USPQ 213 (CCPA 1971)
(Applicant was permitted to claim and submit comparative evidence with
respect to claimed subject matter which originally was only the
preferred embodiment within much broader claims (directed to a
method).). The fact that claims in a continuation application were
directed to originally disclosed subject matter which applicants had not
regarded as part of their invention when the parent application was
filed was held not to prevent the continuation application from
receiving benefits of the filing date of the parent application under 
35 U.S.C. 120. In re Brower, 433 F.2d 813, 167 USPQ 684 (CCPA 1970).

---SECTION---2172.01 Unclaimed Essential Matter

A claim which omits matter disclosed to be essential to the invention as
described in the specification or in other statements of record may be
rejected under  35 U.S.C. 112, first paragraph, as not enabling. In re
Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976).  See also MPEP Section 
2164.08(c).  Such essential matter may include missing elements, steps
or necessary structural cooperative relationships of elements described
by the applicant(s) as necessary to practice the invention.

In addition, a claim which fails to interrelate essential elements of
the invention as defined by applicant(s) in the specification may be
rejected under  35 U.S.C. 112, second paragraph, for failure to point
out and distinctly claim the invention.  See In re Venezia, 530 F.2d
956, 189 USPQ 149 (CCPA 1976); In re Collier, 397 F.2d 1003, 158 USPQ
266 (CCPA 1968).

---SECTION---2173 Claims Must Particularly Point Out and Distinctly
Claim the Invention

The primary purpose of this requirement of definiteness of claim
language is to ensure that the scope of the claims is clear so the
public is informed of the boundaries of what constitutes infringement of
the patent. A secondary purpose is to provide a clear measure of what
applicants regard as the invention so that it can be determined whether
the claimed invention meets all the criteria for patentability and
whether the specification meets the criteria of  35 U.S.C. 112, first
paragraph with respect to the claimed invention.

---SECTION---2173.01 Claim Terminology

A fundamental principle contained in  35 U.S.C. 112, second paragraph is
that applicants are their own lexicographers. They can define in the
claims what they regard as their invention essentially in whatever terms
they choose so long as the terms are not used in ways that are contrary
to accepted meanings in the art. Applicant may use functional language,
alternative expressions, negative limitations, or any style of
expression or format of claim which makes clear the boundaries of the
subject matter for which protection is sought. As noted by the Court in
In re Swinehart, 439 F.2d 210, 160 USPQ 226 (CCPA 1971), a claim may not
be rejected solely because of the type of language used to define the
subject matter for which patent protection is sought.

---SECTION---2173.02 Clarity and Precision

The examiner's focus during examination of claims for compliance with
the requirement for definiteness of  35 U.S.C. 112, second paragraph is
whether the claim meets the threshold requirements of clarity and
precision, not whether more suitable language or modes of expression are
available. When the examiner is satisfied that patentable subject matter
is disclosed, and it is apparent to the examiner that the claims are
directed to such patentable subject matter, he or she should allow
claims which define the patentable subject matter with a   reasonable
degree of particularity and distinctness. Some latitude in the manner of
expression and the aptness of terms should be permitted even though the
claim language is not as precise as the examiner might desire. Examiners
are encouraged to suggest claim language to applicants to improve the
clarity or precision of the language used, but should not reject claims
or insist on their own preferences if other modes of expression selected
by applicants satisfy the statutory requirement.

The essential inquiry pertaining to this requirement is whether the
claims set out and circumscribe a particular subject matter with a
reasonable degree of clarity and particularity. Definiteness of claim
language must be analyzed, not in a vacuum, but in light of:

(A) The content of the particular application disclosure;

(B) The teachings of the prior art; and

(C) The claim interpretation that would be given 	by one possessing the
ordinary level of skill in the pertinent art at the time the invention
was made.  If the scope of the invention sought to be patented cannot be
determined from the language of the claims with a reasonable degree of
certainty, a rejection of the claims under  35 U.S.C. 112, second
paragraph is appropriate. In re Wiggins, 488 F.2d 538, 179 USPQ 421
(CCPA 1973).

---SECTION---2173.03 Inconsistency Between Claim and Specification
Disclosure or Prior Art

Although the terms of a claim may appear to be definite, inconsistency
with the specification disclosure or prior art teachings may make an
otherwise definite claim take on an unreasonable degree of uncertainty.
In re Cohn, 438 F.2d 989, 169 USPQ 95 (CCPA 1971); In re Hammack, 427
F.2d 1378, 166 USPQ 204 (CCPA 1970). In Cohn, the claim was directed to
a process of treating a surface with a corroding solution until the
metallic appearance is supplanted by an "opaque" appearance. Noting that
no claim may be read apart from and independent of the supporting
disclosure on which it is based, the court found that the description,
definitions and examples set forth in the specification relating to the
appearance of the surface after treatment were inherently inconsistent
and rendered the claim indefinite.

---SECTION---2173.04 Breadth Is Not Indefiniteness

Breadth of a claim is not to be equated with indefiniteness. In re
Miller, 441 F.2d 689, 169 USPQ 597 (CCPA 1971). If the scope of the
subject matter embraced by the claims is clear, and if applicants have
not otherwise indicated that they intend the invention to be of a scope
different from that defined in the claims, then the claims comply with 
35 U.S.C. 112, second paragraph.

Undue breadth of the claim may be addressed under different statutory
provisions, depending on the reasons for concluding that the claim is
too broad. If the claim is too broad because it does not set forth that
which applicants regard as their invention as evidenced by statements
outside of the application as filed, a rejection under  35 U.S.C. 112,
second paragraph would be appropriate. If the claim is too broad because
it is not supported by the original description or by an enabling
disclosure, a rejection under  35 U.S.C. 112, first paragraph would be
appropriate. If the claim is too broad because it reads on the prior
art, a rejection under either  35 U.S.C. 102 or 103 would be
appropriate.

---SECTION---2173.05 Specific Topics Related to Issues Under 35 U.S.C.
112, Second Paragraph

The following sections are devoted to a discussion of specific topics
where issues under  35 U.S.C. 112, second paragraph have been addressed.
These sections are not intended to be an exhaustive list of the issues
that can arise under  35 U.S.C. 112, second paragraph, but are intended
to provide guidance in areas that have been addressed with some
frequency in recent examination practice. The court and Board decisions
cited are representative. As with all appellate decisions, the results
are largely dictated by the facts in each case. The use of the same
language in a different context may justify a different result.

---SECTION---2173.05(a) New Terminology

THE MEANING OF EVERY TERM SHOULD BE APPARENT

The meaning of every term used in a claim should be apparent from the
prior art or from the specification and drawings at the time the
application is filed. Applicants need not confine themselves to the
terminology used in the prior art, but are required to make clear and
precise the terms that are used to define the invention whereby the
metes and bounds of the claimed invention can be ascertained. During
patent examination, the pending claims must be given the broadest
reasonable interpretation consistent with the specification. In re
Prater, 415 F.2d 1393, 162 USPQ 541 (CCPA 1969). See also MPEP Section 
2111 -  Section  2111.01. When the specification states the meaning that
a term in the claim is intended to have, the claim is examined using
that meaning, in order to achieve a complete exploration of the
applicant's invention and its relation to the prior art. In re Zletz,
893 F.2d 319, 13 USPQ2d 1320 (Fed. Cir. 1989).

THE REQUIREMENT FOR CLARITY AND PRECISION MUST BE BALANCED WITH THE
LIMITATIONS OF THE LANGUAGE

Courts have recognized that it is not only permissible, but often
desirable, to use new terms that are frequently more precise in
describing and defining the new invention. In re Fisher, 427 F.2d 833,
166 USPQ 18 (CCPA 1970). Although it is difficult to compare the claimed
invention with the prior art when new terms are used that do not appear
in the prior art, this does not make the new terms indefinite.

New terms are often used when a new technology is in its infancy or is
rapidly evolving. The requirements for clarity and precision must be
balanced with the limitations of the language and the science. If the
claims, read in light of the specification, reasonably apprise those
skilled in the art both of the utilization and scope of the invention,
and if the language is as precise as the subject matter permits, the
statute (35 U.S.C. 112, second paragraph) demands no more. Shatterproof
Glass Corp. v. Libbey Owens Ford Co., 758 F.2d 613, 225 USPQ 634 (Fed.
Cir. 1985) (interpretation of "freely supporting" in method claims
directed to treatment of a glass sheet);   Hybritech, Inc. v. Monoclonal
Antibodies, Inc., 802 F.2d 1367, 231 USPQ 81 (Fed. Cir. 1986)
(interpretation of a limitation specifying a numerical value for
antibody affinity where the method of calculation was known in the art
at the time of filing to be imprecise). This does not mean that the
examiner must accept the best effort of applicant. If the proposed
language is not considered as precise as the subject matter permits, the
examiner should provide reasons to support the conclusion of
indefiniteness and is encouraged to suggest alternatives that are free
from objection.

A TERM MAY NOT BE GIVEN A MEANING REPUGNANT TO ITS USUAL MEANING

While a term used in the claims may be given a special meaning in the
description of the invention, generally no term may be given a meaning
repugnant to the usual meaning of the term. In re Hill, 161 F.2d 367, 73
USPQ 482 (CCPA 1947). However, it has been stated that consistent with
the well-established axiom in patent law that a patentee is free to be
his or her own lexicographer, a patentee may use terms in a manner
contrary to or inconsistent with one or more of their ordinary meanings.
Hormone Research Foundation Inc. v. Genentech Inc., 904 F.2d 1558, 15
USPQ2d 1039 (Fed. Cir. 1990). Accordingly, when there is more than one
definition for a term, it is incumbent upon applicant to make clear
which definition is being relied upon to claim the invention. Until the
meaning of a term or phrase used in a claim is clear, a rejection under 
35 U.S.C. 112, second paragraph is appropriate. It is appropriate to
compare the meaning of terms given in technical dictionaries in order to
ascertain the accepted meaning of a term in the art. In re Barr, 444
F.2d 588, 170 USPQ 330 (CCPA 1971).

---SECTION---2173.05(b) Relative Terminology

The fact that claim language, including terms of degree, may not be
precise, does not automatically render the claim indefinite under  35
U.S.C. 112, second paragraph. Seattle Box Co., v. Industrial Crating &
Packing, Inc., 731 F.2d 818, 221 USPQ 568 (Fed. Cir. 1984).
Acceptability of the claim language depends on whether one of ordinary
skill in the art would understand what is claimed, in light of the
specification.

WHEN A TERM OF DEGREE IS PRESENT, DETERMINE WHETHER A STANDARD IS
DISCLOSED OR WHETHER ONE OF ORDINARY SKILL IN THE ART WOULD BE APPRISED
OF THE SCOPE OF THE CLAIM

When a term of degree is presented in a claim, first a determination is
to be made as to whether the specification provides some standard for
measuring that degree. If it does not, a determination is made as to
whether one of ordinary skill in the art, in view of the prior art and
the status of the art, would be nevertheless reasonably apprised of the
scope of the invention. Even if the specification uses the same term of
degree as in the claim, a rejection may be proper if the scope of the
term is not understood when read in light of the specification. While,
as a general proposition, broadening modifiers are standard tools in
claim drafting in order to avoid reliance on the doctrine of equivalents
in infringement actions, when the scope of the claim is unclear a
rejection under  35 U.S.C. 112, second paragraph is proper. See In re
Wiggins, 488 F. 2d 538, 541, 179 USPQ 421, 423 (CCPA 1973).

When relative terms are used in claims wherein the improvement over the
prior art rests entirely upon size or weight of an element in a
combination of elements, the adequacy of the disclosure of a standard is
of greater criticality.

REFERENCE TO AN OBJECT THAT IS VARIABLE MAY RENDER A CLAIM INDEFINITE

A claim may be rendered indefinite by reference to an object that is
variable. For example, the Board has held that a limitation in a claim
to a bicycle that recited "said front and rear wheels so spaced as to
give a wheelbase that is between 58 percent and 75 percent of the height
of the rider that the bicycle was designed for" was indefinite because
the relationship of parts was not based on any known standard for sizing
a bicycle to a rider, but on a rider of unspecified build. Ex parte
Brummer, 12 USPQ2d 1653 (Bd. Pat. App. & Inter. 1989). On the other
hand, a claim limitation specifying that a certain part of a pediatric
wheelchair be "so dimensioned as to be insertable through the space
between the doorframe of an automobile and one of the seats" was held to
be definite. Orthokinetics, Inc. v. Safety Travel Chairs, Inc., 806 F.2d
1565, 1 USPQ2d 1081 (Fed. Cir. 1986). The court stated that the phrase
"so dimensioned" is as accurate as the subject matter permits, noting
that the patent law does not require that all possible lengths
corresponding to the spaces in hundreds of different automobiles be
listed in the patent, let alone that they be listed in the claims.

A. "About"

The term "about" used to define the area of the lower end of a mold as
between 25 to about 45% of the mold entrance was held to be clear, but
flexible. Ex parte Eastwood, 163 USPQ 316 (Bd. App. 1968).  Similarly,
in W.L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220
USPQ 303 (Fed. Cir. 1983), the court held that a limitation defining the
stretch rate of a plastic as "exceeding about 10% per second" is
definite because infringement could clearly be assessed through the use
of a stopwatch. However, the court held that claims reciting "at least
about" were invalid for indefiniteness where there was close prior art
and there was nothing in the specification, prosecution history, or the
prior art to provide any indication as to what range of specific
activity is covered by the term "about." Amgen, Inc.  v. Chugai
Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991).

B. "Essentially"

The phrase "a silicon dioxide source that is essentially free of alkali
metal" was held to be definite because the specification contained
guidelines and examples that were considered sufficient to enable a
person of ordinary skill in the art to draw a line between unavoidable
impurities in starting materials and essential ingredients. In re
Marosi, 710 F.2d 799, 218 USPQ 289 (CCPA 1983). The court further
observed that it would be impractical to require applicants to specify a
particular number as a cutoff between their invention and the prior art.

C. "Similar"

The term "similar" in the preamble of a claim that was directed to a
nozzle "for high-pressure cleaning units or similar apparatus" was held
to be indefinite since it was not clear what applicant intended to cover
by the recitation "similar" apparatus. Ex parte Kristensen, 10 USPQ2d
1701 (Bd. Pat. App. & Inter. 1989).

A claim in a design patent application which read: "The ornamental
design for a feed bunk or similar structure as shown and described." was
held to be indefinite because it was unclear from the specification what
applicant intended to cover by the recitation of "similar structure." Ex
parte Pappas, 23 USPQ2d 1636 (Bd. Pat. App. & Inter. 1992).

D. "Substantially"

The term "substantially" is often used in conjunction with another term
to describe a particular characteristic of the claimed invention. It is
a broad term. In re Nehrenberg, 280 F.2d 161, 126 USPQ 383 (CCPA 1960).
The court held that the limitation "to substantially increase the
efficiency of the compound as a copper extractant" was definite in view
of the general guidelines contained in the specification. In re
Mattison, 509 F.2d 563, 184 USPQ 484 (CCPA 1975). The court held that
the limitation "which produces substantially equal E and H plane
illumination patterns" was definite because one of ordinary skill in the
art would know what was meant by "substantially equal." Andrew Corp. v.
Gabriel Electronics, 847 F.2d 819, 6 USPQ2d 2010 (Fed. Cir. 1988).

E. "Type"

The addition of the word "type" to an otherwise definite expression
(e.g., Friedel-Crafts catalyst) extends the scope of the expression so
as to render it indefinite.   Ex parte Copenhaver, 109 USPQ 118 (Bd.
App. 1955). Likewise, the phrase "ZSM-5-type aluminosilicate zeolites"
was held to be indefinite because it was unclear what "type" was
intended to convey. The interpretation was made more difficult by the
fact that the zeolites defined in the dependent claims were not within
the genus of the type of zeolites defined in the independent claim. Ex
parte Attig, 7 USPQ2d 1092 (Bd. Pat. App. & Inter. 1986).

F. Other Terms

The phrases "relatively shallow," "of the order of," "the order of about
5mm," and "substantial portion" were held to be indefinite because the
specification lacked some standard for measuring the degree intended
and, therefore, properly rejected as indefinite under  35 U.S.C. 112,
second paragraph. Ex parte Oetiker, 23 USPQ2d 1641 (Bd. Pat. App. &
Inter. 1992).

The term "or like material" in the context of the limitation "coke,
brick, or like material" was held to render the claim indefinite since
it was not clear how the materials other than coke or brick had to
resemble the two specified materials to satisfy the limitations of the
claim. Ex parte Caldwell, 1906 C.D. 58 (Comm'r Pat. 1906).

The terms "comparable" and "superior" were held to be indefinite in the
context of a limitation relating the characteristics of the claimed
material to other materials - "properties that are superior to those
obtained with comparable" prior art materials. Ex parte Anderson, 21
USPQ2d 1241 (Bd. Pat. App. & Inter. 1991). It was not clear from the
specification which properties had to be compared and how comparable the
properties would have to be to determine infringement issues. Further,
there was no guidance as to the meaning of the term "superior."

---SECTION---2173.05(c) Numerical Ranges and Amounts Limitations

Generally, the recitation of specific numerical ranges in a claim does
not raise an issue of whether a claim is definite.

I. NARROW AND BROADER RANGES IN THE SAME CLAIM

Use of a narrow numerical range that falls within a broader range in the
same claim may render the claim indefinite when the boundaries of the
claim are not discernible. Description of examples and preferences is
properly set forth in the specification rather than in the claims. If
stated in the claims, examples and preferences lead to confusion over
the intended scope of a claim. In those instances where it is not clear
whether the claimed narrower range is a limitation, a rejection under 
35 U.S.C. 112, second paragraph should be made. The Examiner should
analyze whether the metes and bounds of the claim are clearly set forth.
Examples of claim language which have been held to be indefinite are (A)
"a temperature of between 45 and 78 degrees Celsius, preferably between
50 and 60 degrees Celsius"; and (B) "a predetermined quantity, for
example, the maximum capacity."

II. OPEN-ENDED NUMERICAL RANGES

Open-ended numerical ranges should be carefully analyzed for
definiteness. For example, when an independent claim recites a
composition comprising "at least 20% sodium" and a dependent claim sets
forth specific amounts of nonsodium ingredients which add up to 100%,
apparently to the exclusion of sodium, an ambiguity is created with
regard to the "at least" limitation (unless the percentages of the
nonsodium ingredients are based on the weight of the nonsodium
ingredients). On the other hand, the court held that a composition
claimed to have a theoretical content greater than 100% (i.e., 20-80% of
A, 20-80% of B, and 1-25% of C) was not indefinite simply because the
claims may be read in theory to include compositions that are impossible
in fact to formulate. It was observed that subject matter which cannot
exist in fact can neither anticipate nor infringe a claim. In re
Kroekel, 504 F.2d 1143, 183 USPQ 610 (CCPA 1974).

In a claim directed to a chemical reaction process, a limitation
required that the amount of one ingredient in the reaction mixture
should "be maintained at less than 7 mole percent" based on the amount
of another ingredient. The examiner argued that the claim was indefinite
because the limitation sets only a maximum amount and is inclusive of
substantially no ingredient resulting in termination of any reaction.
The court did not agree be cause the claim was clearly directed to a
reaction process which did not warrant distorting the overall meaning of
the claim to preclude performing the claimed process. In re Kirsch, 498
F.2d 1389, 182 USPQ 286 (CCPA 1974).

Some terms have been determined to have the following meanings in the
factual situations of the reported cases: the term "up to" includes zero
as a lower limit, In re Mochel, 470 F.2d 638, 176 USPQ 194 (CCPA 1974);
and "a moisture content of not more than 70% by weight" reads on dry
material, Ex parte Khusid, 174 USPQ 59 (Bd. App. 1971).

III. "EFFECTIVE AMOUNT"

The common phrase "an effective amount" may or may not be indefinite.
The proper test is whether or not one skilled in the art could determine
specific values for the amount based on the disclosure. See In re
Mattison, 509 F.2d 563, 184 USPQ 484 (CCPA 1975). The phrase "an
effective amount . . . for growth stimulation" was held to be definite
where the amount was not critical and those skilled in the art would be
able to determine from the written disclosure, including the examples,
what an effective amount is. In re Halleck, 422 F.2d 911, 164 USPQ 647
(CCPA 1970). The phrase "an effective amount" has been held to be
indefinite when the claim fails to state the function which is to be
achieved and more than one effect can be implied from the specification
or the relevant art. In re Fredericksen 213 F.2d 547, 102 USPQ 35 (CCPA
1954). The more recent cases have tended to accept a limitation such as
"an effective amount" as being definite when read in light of the
supporting disclosure and in the absence of any prior art which would
give rise to uncertainty about the scope of the claim. In Ex parte
Skuballa, 12 USPQ2d 1570 (Bd. Pat. App. & Inter. 1989), the Board held
that a pharmaceutical composition claim which recited an "effective
amount of a compound of claim 1" without stating the function to be
achieved was definite, particularly when read in light of the supporting
disclosure which provided guidelines as to the intended utilities and
how the uses could be effected.

---SECTION---2173.05(d) Exemplary Claim Language ("for example," "such
as")

Description of examples or preferences is properly set forth in the
specification rather than the claims. If stated in the claims, examples
and preferences lead to confusion over the intended scope of a claim. In
those instances where it is not clear whether the claimed narrower range
is a limitation, a rejection under  35 U.S.C. 112, second paragraph
should be made. The Examiner should analyze whether the metes and bounds
of the claim are clearly set forth. Examples of claim language which
have been held to be indefinite because the intended scope of the claim
was unclear are:

(A) "R is halogen, for example, chlorine";

(B) "material such as rock wool or asbestos" Ex parte Hall, 83 USPQ 38
(Bd. App. 1949);

(C) "lighter hydrocarbons, such, for example, as the vapors or gas
produced" Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949); and

(D) "normal operating conditions such as while in the container of a
proportioner" Ex parte Steigerwald, 131 USPQ 74 (Bd. App. 1961).

---SECTION---2173.05(e) Lack of Antecedent Basis

A claim is indefinite when it contains words or phrases whose meaning is
unclear. The lack of clarity could arise where a claim refers to "said
lever" or "the lever," where the claim contains no earlier recitation or
limitation of a lever and where it would be unclear as to what element
the limitation was making reference. Similarly, if two different levers
are recited earlier in the claim, the recitation of "said lever" in the
same or subsequent claim would be unclear where it is uncertain which of
the two levers was intended. A claim which refers to "said aluminum
lever," but recites only "a lever" earlier in the claim, is indefinite
because it is uncertain as to the lever to which reference is made.
Obviously, however, the failure to provide explicit antecedent basis for
terms does not always render a claim indefinite. If the scope of a claim
would be reasonably ascertainable by those skilled in the art, then the
claim is not indefinite. Ex parte Porter, 25 USPQ2d 1144, 1145 (Bd. Pat.
App. & Inter. 1992) ("controlled stream of fluid" provided reasonable
antecedent basis for "the controlled fluid"). Inherent components of
elements recited have antecedent basis in the recitation of the
components themselves. For example, the limitation "the outer surface of
said sphere" would not require an antecedent recitation that the sphere
has an outer surface.

EXAMINER SHOULD SUGGEST CORRECTIONS TO ANTECEDENT PROBLEMS

Antecedent problems in the claims are typically drafting oversights that
are easily corrected once they are brought to the attention of
applicant. The examiner's task of making sure the claim language
complies with the requirements of the statute should be carried out in a
positive and constructive way, so that minor problems can be identified
and easily corrected, and so that the major effort is expended on more
substantive issues. However, even though indefiniteness in claim
language is of semantic origin, it is not rendered unobjectionable
simply because it could have been corrected. In re Hammack, 427 F.2d
1384 n.5, 166 USPQ 209 n.5 (CCPA 1970).

A CLAIM TERM WHICH HAS NO ANTECEDENT BASIS IN THE DISCLOSURE IS NOT
NECESSARILY INDEFINITE

The mere fact that a term or phrase used in the claim has no antecedent
basis in the specification disclosure does not mean, necessarily, that
the term or phrase is indefinite. There is no requirement that the words
in the claim must match those used in the specification disclosure.
Applicants are given a great deal of latitude in how they choose to
define their invention so long as the terms and phrases used define the
invention with a reasonable degree of clarity and precision.

---SECTION---2173.05(f) Reference to Limitations in Another Claim

A claim which makes reference to a preceding claim to define a
limitation is an acceptable claim construction which should not
necessarily be rejected as improper or confusing under  35 U.S.C. 112,
second paragraph. For example, claims which read: "The product produced
by the method of claim 1." or "A method of producing ethanol comprising
contacting amylose with the culture of claim 1 under the following
conditions ....." are not indefinite under  35 U.S.C. 112, second
paragraph, merely because of the reference to another claim. See also Ex
parte Porter, 25 USPQ2d 1144 (Bd. Pat. App. & Inter. 1992) where
reference to "the nozzle of claim 7" in a method claim was held to
comply with  35 U.S.C. 112, second paragraph. However, where the format
of making reference to limitations recited in another claim results in
confusion, then a rejection would be proper under  35 U.S.C. 112, second
paragraph.

---SECTION---2173.05(g) Functional Limitations

A functional limitation is an attempt to define something by what it
does, rather than by what it is (e.g., as evidenced by its specific
structure or specific ingredients). There is nothing inherently wrong
with defining some part of an invention in functional terms. Functional
language does not, in and of itself, render a claim improper. In re
Swinehart, 439 F.2d 210, 169 USPQ 226 (CCPA 1971).

A functional limitation must be evaluated and considered, just like any
other limitation of the claim, for what it fairly conveys to a person of
ordinary skill in the pertinent art in the context in which it is used.
A functional limitation is often used in association with an element,
ingredient, or step of a process to define a particular capability or
purpose that is served by the recited element, ingredient or step.
Whether or not the functional limitation complies with  35 U.S.C. 112,
second paragraph is a different issue from whether the limitation is
properly supported under  35 U.S.C. 112, first paragraph or is
distinguished over the prior art. A few examples are set forth below to
illustrate situations where the issue of whether a functional limitation
complies with  35 U.S.C. 112, second paragraph was considered.

It was held that the limitation used to define a radical on a chemical
compound as "incapable of forming a dye with said oxidizing developing
agent" although functional, was perfectly acceptable because it set
definite boundaries on the patent protection sought. In re Barr, 444
F.2d 588, 170 USPQ 33 (CCPA 1971).

In a claim that was directed to a kit of component parts capable of
being assembled, the Court held that limitations such as "members
adapted to be positioned" and "portions . . . being resiliently
dilatable whereby said housing may be slidably positioned" serve to
precisely define present structural attributes of interrelated component
parts of the claimed assembly. In re Venezia, 530 F.2d 956, 189 USPQ 149
(CCPA 1976).

---SECTION---2173.05(h) Alternative Limitations

I. MARKUSH GROUPS

Alternative expressions are permitted if they present no uncertainty or
ambiguity with respect to the question of scope or clarity of the
claims. One acceptable form of alternative expression, which is commonly
referred to as a Markush group, recites members as being "selected from
the group consisting of A, B and C." See Ex parte Markush, 1925 C.D. 126
(Comm'r Pat. 1925).

Ex parte Markush sanctions claiming a genus expressed as a group
consisting of certain specified materials. Inventions in metallurgy,
refractories, ceramics, pharmacy, pharmacology and biology are most
frequently claimed under the Markush formula but purely mechanical
features or process steps may also be claimed by using the Markush style
of claiming. See Ex parte Head, 214 USPQ 551 (Bd. App. 1981); In re
Gaubert, 524 F.2d 1222, 187 USPQ 664 (CCPA 1975); and In re Harnisch,
631 F.2d 716, 206 USPQ 300 (CCPA 1980). It is improper to use the term
"comprising" instead of "consisting of." Ex parte Dotter, 12 USPQ 382
(Bd. App. 1931).

The use of Markush claims of diminishing scope should not, in itself, be
considered a sufficient basis for objection to or rejection of claims.
However, if such a practice renders the claims indefinite or if it
results in undue multiplicity, an appropriate rejection should be made.

Similarly, the double inclusion of an element by members of a Markush
group is not, in itself, sufficient basis for objection to or rejection
of claims. Rather, the facts in each case must be evaluated to determine
whether or not the multiple inclusion of one or more elements in a claim
renders that claim indefinite. The mere fact that a compound may be
embraced by more than one member of a Markush group recited in the claim
does not necessarily render the scope of the claim unclear. For example,
the Markush group, "selected from the group consisting of amino,
halogen, nitro, chloro and alkyl" should be acceptable even though
"halogen" is generic to "chloro."

The materials set forth in the Markush group ordinarily must belong to a
recognized physical or chemical class or to an art-recognized class.
However, when the Markush group occurs in a claim reciting a process or
a combination (not a single compound), it is sufficient if the members
of the group are disclosed in the specification to possess at least one
property in common which is mainly responsible for their function in the
claimed relationship, and it is clear from their very nature or from the
prior art that all of them possess this property. While in the past the
test for Markush-type claims was applied as liberally as possible,
present practice which holds that claims reciting Markush groups are not
generic claims (MPEP Section  803) may subject the groups to a more
stringent test for propriety of the recited members. Where a Markush
expression is applied only to a portion of a chemical compound, the
propriety of the grouping is determined by a consideration of the
compound as a whole, and does not depend on there being a community of
properties in the members of the Markush expression.

When materials recited in a claim are so related as to constitute a
proper Markush group, they may be recited in the conventional manner, or
alternatively. For example, if "wherein R is a material selected from
the group consisting of A, B, C and D" is a proper limitation, then
"wherein R is A, B, C or D" shall also be considered proper.

Subgenus Claim

A situation may occur in which a patentee has presented a number of
examples which, in the examiner's opinion, are sufficiently
representative to support a generic claim and yet a court may
subsequently hold the claim invalid on the ground of undue breadth.
Where this happens the patentee is often limited to species claims which
may not provide him with suitable protection.

The allowance of a Markush-type claim under a true genus claim would
appear to be beneficial to the applicant without imposing any undue
burden on the Patent and Trademark Office or in any way detracting from
the rights of the public. Such a subgenus claim would enable the
applicant to claim all the disclosed operative embodiments and afford
applicant an intermediate level of protection in the event the true
genus claims should be subsequently held invalid.

The examiners are therefore instructed not to reject a Markush-type
claim merely because of the presence of a true genus claim embracive
thereof.

See also MPEP Section  608.01(p) and Section  715.03.

See MPEP Section  803.02 for restriction practice re Markush-type
claims.

II. "OR" TERMINOLOGY

Alternative expressions using "or" are acceptable, such as "wherein R is
A, B, C, or D." The following phrases were each held to be acceptable
and not in violation of  35 U.S.C. 112, second paragraph in In re
Gaubert, 524 F.2d 1222, 187 USPQ 664 (CCPA 1975): "made entirely or in
part of"; "at least one piece"; and "iron, steel or any other magnetic
material."

III. "OPTIONALLY"

An alternative format which requires some analysis before concluding
whether or not the language is indefinite involves the use of the term
"optionally." In Ex parte Cordova, 10 USPQ2d 1949 (Bd. Pat. App. &
Inter. 1989) the language "containing A, B, and optionally C" was
considered acceptable alternative language because there was no
ambiguity as to which alternatives are covered by the claim. A similar
holding was reached with regard to the term "optionally" in Ex parte Wu,
10 USPQ2d 2031 (Bd. Pat. App. & Inter. 1989). In the instance where the
list of potential alternatives can vary and ambiguity arises, then it is
proper to make a rejection under  35 U.S.C. 112, second paragraph and
explain why there is confusion.

---SECTION---2173.05(i) Negative Limitations

The current view of the courts is that there is nothing inherently
ambiguous or uncertain about a negative limitation. So long as the
boundaries of the patent protection sought are set forth definitely,
albeit negatively, the claim complies with the requirements of  35
U.S.C. 112, second paragraph. Some older cases were critical of negative
limitations because they tended to define the invention in terms of what
it was not, rather than pointing out the invention. Thus, the court
observed that the limitation "R is an alkenyl radical other than
2-butenyl and 2,4-pentadienyl" was a negative limitation that rendered
the claim indefinite because it was an attempt to claim the invention by
excluding what the inventors did not invent rather than distinctly and
particularly pointing out what they did invent. In re Schechter, 205
F.2d 185, 98 USPQ 144 (CCPA 1953).

A claim which recited the limitation "said homopolymer being free from
the proteins, soaps, resins, and sugars present in natural Hevea rubber"
in order to exclude the characteristics of the prior art product, was
considered definite because each recited limitation was definite. In re
Wakefield, 422 F.2d 897, 899, 904, 164 USPQ 636, 638, 641 (CCPA 1970).
In addition, the court found that the negative limitation "incapable of
forming a dye with said oxidized developing agent" was definite because
the boundaries of the patent protection sought were clear.  In re Barr,
444 F.2d 588, 170 USPQ 330 (CCPA 1971).

Any negative limitation or exclusionary proviso must have basis in the
original disclosure. See Ex parte Grasselli, 231 USPQ 393 (Bd. App.
1983), aff'd mem., 738 F.2d 453 (Fed. Cir. 1984). The mere absence of a
positive recitation is not basis for an exclusion. Any claim containing
a negative limitation which does not have basis in the original
disclosure should be rejected under  35 U.S.C. 112, first paragraph as
failing to comply with the written description requirement. Note that a
lack of literal basis in the specification for a negative limitation may
not be sufficient to establish a prima facie case for lack of
descriptive support. Ex parte Parks, 30 USPQ2d  1234, 1236 (Bd. Pat.
App. & Inter. 1993). See MPEP Section  2163 -  Section  2163.07(b) for a
discussion of the written description requirement of  35 U.S.C. 112,
first paragraph.

---SECTION---2173.05(j) Old Combination

A CLAIM SHOULD NOT BE REJECTED ON THE GROUND OF OLD COMBINATION

With the passage of the 1952 Patent Act, the courts and the Board have
taken the view that a rejection based on the principle of old
combination is NO LONGER VALID. Claims should be considered proper so
long as they comply with the provisions of  35 U.S.C. 112, second
paragraph.

A rejection on the basis of old combination was based on the principle
applied in Lincoln Engineering Co. v. Stewart-Warner Corp., 303 U.S.
545, 37 USPQ 1 (1938). The principle was that an inventor who made an
improvement or contribution to but one element of a generally old
combination, should not be able to obtain a patent on the entire
combination including the new and improved element. A rejection required
the citation of a single reference which broadly disclosed a combination
of the claimed elements functionally cooperating in substantially the
same manner to produce substantially the same results as that of the
claimed combination. The case of In re Hall, 208 F.2d 370, 100 USPQ 46
(CCPA 1953) illustrates an application of this principle.

The court pointed out in In re Bernhardt, 417 F.2d 1395, 163 USPQ 611
(CCPA 1969) that the statutory language (particularly point out and
distinctly claim) is the only proper basis for an old combination
rejection, and in applying the rejection, that language determines what
an applicant has a right and obligation to do. A majority opinion of the
Board of Appeals held that Congress removed the underlying rationale of
Lincoln Engineering in the 1952 Patent Act, and thereby effectively
legislated that decision out of existence. Ex parte Barber, 187 USPQ 244
(Bd. App. 1974). Finally, the Court of Appeals for the Federal Circuit,
in Radio Steel and Mfg. Co. v. MTD Products, Inc., 731 F.2d 840, 221
USPQ 657 (Fed. Cir. 1984), followed the Bernhardt case, and ruled that a
claim was not invalid under Lincoln Engineering because the claim
complied with the requirements of  35 U.S.C. 112, second paragraph.
Accordingly, a claim should not be rejected on the ground of old
combination.

---SECTION---2173.05(k) Aggregation

Rejections on the ground of aggregation should be based upon a lack of
cooperation between the elements of the claim.

Example of aggregation: A washing machine associated with a dial
telephone.

A claim is not necessarily aggregative because the various elements do
not function simultaneously, e.g., a typewriter. In re Worrest, 201 F.2d
930, 96 USPQ 381 (CCPA 1953). Neither is a claim necessarily aggregative
merely because elements which do cooperate are set forth in specific
detail.

A rejection on aggregation should be made only after consideration of
the court's comments in In re Gustafson, 331 F.2d 905, 141 USPQ 585
(CCPA 1964), wherein the court indicated it is improper to reject claims
as "aggregative" without specifying the statutory basis of the
rejection, i.e., an applicant is entitled to know whether his claims are
being rejected under  35 U.S.C. 101, 103, or 112. In Gustafson, the
court found that the real objection to the claims was that they failed
to comply with  35 U.S.C. 112, second paragraph.

---SECTION---2173.05(m) Prolix

Examiners should reject claims as prolix only when they contain such
long recitations or unimportant details that the scope of the claimed
invention is rendered indefinite thereby. Claims are rejected as prolix
when they contain long recitations or unimportant details which hide or
obscure the invention.  Ex parte Iagan, 1911 C.D. 10, 162 O.G. 538
(Comm'r Pat. 1910), expresses the thought that very long detailed claims
setting forth so many elements that invention cannot possibly reside in
the combination should be rejected as prolix. See also   In re Ludwick,
4 F.2d 959, 1925 C.D. 306, 339 O.G. 393 (D.C. Cir. 1925).

---SECTION---2173.05(n) Multiplicity

37 CFR 1.75 Claim(s).

(a) The specification must conclude with a claim particularly pointing
out and distinctly claiming the subject matter which the applicant
regards as his invention or discovery.

(b) More than one claim may be presented provided they differ
substantially from each other and are not unduly multiplied.

(c) One or more claims may be presented in dependent form, referring
back to and further limiting another claim or claims in the same
application. Any dependent claim which refers to more than one other
claim ("multiple dependent claim") shall refer to such other claims in
the alternative only. A multiple dependent claim shall not serve as a
basis for any other multiple dependent claim. For fee calculation
purposes under Section  1.16, a multiple dependent claim will be
considered to be that number of claims to which direct reference is made
therein. For fee calculation purposes, also, any claim depending from a
multiple dependent claim will be considered to be that number of claims
to which direct reference is made in that multiple dependent claim. In
addition to the other filing fees, any original application which is
filed with, or is amended to include, multiple dependent claims must
have paid the fee set forth in Section  1.16(d). Claims in dependent
form shall be construed to include all the limitations of the claim
incorporated by reference into the dependent claim. A multiple dependent
claim shall be construed to incorporate by reference all the limitations
of each of the particular claims In relation to which it is being
considered.

(d) (1) The claim or claims must conform to the invention as set forth
in the remainder of the specification and the terms and phrases used in
the claims must find clear support or antecedent basis in the
description so that the meaning of the terms may be ascertained by
reference to the description (See Section  1.58(a)).

(2) See Section Section  1.141 to 1.146 as to claiming different
inventions in one application.

(e) Where the nature of the case admits, as in the case of an
improvement, any independent claim should contain in the following
order, (1) a preamble comprising a general description of all elements
or steps of the claimed combination which are conventional or known, (2)
a phrase such as "wherein the improvement comprises," and (3) those
elements, steps, and/or relationships which constitute that portion of
the claimed combination which the applicant regards as the new or
improved portion.

(f) If there are several claims, they shall be numbered consecutively in
Arabic numerals.

(g) The least restrictive claim should be presented as claim number 1,
and all dependent claims should be grouped together with the claim or
claims to which they refer to the extent practicable.

(h) The claim or claims must commence on a separate sheet.

(i) Where a claim sets forth a plurality of elements or steps, each
element or step of the claim should be separated by a line indentation.

An unreasonable number of claims, that is, unreasonable in view of the
nature and scope of applicant's invention and the state of the art, may
afford a basis for a rejection on the ground of multiplicity. A
rejection on this ground should include all the claims in the case
inasmuch as it relates to confusion of the issue.

To avoid the possibility that an application which has been rejected on
the ground of undue multiplicity of claims may be appealed to the Board
of Patent Appeals and Interferences prior to an examination on the
merits of at least some of the claims presented, the examiner should, at
the time of making the rejection on the ground of multiplicity of
claims, specify the number of claims which in his or her judgment is
sufficient to properly define applicant's invention and require the
applicant to select certain claims, not to exceed the number specified,
for examination on the merits. The examiner should be reasonable in
setting the number to afford the applicant some latitude in claiming the
invention.

The earlier views of the Court of Customs and Patent Appeals on
multiplicity were set forth in In re Chandler, 254 F.2d 396, 117 USPQ
361 (1958) and In re Chandler, 319 F.2d 211, 225, 138 USPQ 138, 148 
(1963) (Applicant's latitude in stating their claims in regard to number
and phraseology employed "should not be extended to sanction that degree
of repetition and multiplicity which beclouds definition in a maze of
confusion."). These views have been somewhat revised by its views in In
re Flint, 411 F.2d 1353, 1357, 162 USPQ 228, 231 (CCPA 1969) ("The [42]
claims differed from one another and we have no difficulty in
understanding the scope of protection. Nor is it clear, on this record,
that the examiner or board was confused by the presentation of claims in
this case or that the public will be.") and In re Wakefield, 422 F.2d
897, 902, 164 USPQ 636, 639 (CCPA 1970) ("Examination of forty claims in
a single application may be tedious work, but this is no reason for
saying that the invention is obscured by the large number of claims. We
note that the claims were clear enough for the examiner to apply
references against all of them in his first action.").

If a rejection on multiplicity is in order the examiner should make a
telephone call explaining that the claims are unduly multiplied and will
be rejected on that ground. Note MPEP Section  408. The examiner should
request selection of a specified number of claims for purposes of
examination.

If time for consideration is requested arrangements should be made for a
second telephone call, preferably within three working days.

When claims are selected, a formal multiplicity rejection is made,
including a complete record of the telephone interview, followed by an
action on the selected claims.

When applicant refuses to comply with the telephone request, a formal
multiplicity rejection is made. The applicant's reply to a formal
multiplicity rejection of the examiner, to be complete, must either:

(A) Reduce the number of claims presented to those selected previously
by telephone, or if no previous selection has been made to a number not
exceeding the number specified by the examiner in the Office action,
thus overcoming the rejection based upon the ground of multiplicity, or

(B) In the event of a traverse of said rejection applicant, besides
specifically pointing out the supposed errors of the multiplicity
rejection, is required to confirm the selection previously made by
telephone, or if no previous selection has been made, select certain
claims for purpose of examination, the number of which is not greater
than the number specified by the examiner.

If the rejection on multiplicity is adhered to, all claims retained will
be included in such rejection and the selected claims only will be
additionally examined on their merits. This procedure preserves
applicant's right to have the rejection on multiplicity reviewed by the
Board of Patent Appeals and Interferences.

Also, it is possible to reject one claim on an allowed claim if they
differ only by subject matter old in the art. This ground of rejection
is set forth in Ex parte Whitelaw, 1915 C.D. 18, 219 O.G. 1237 (Comm'r
Pat. 1914). The Ex parte Whitelaw doctrine is restricted to cases where
the claims are unduly multiplied or are substantial duplicates. Ex parte
Kochan, 131 USPQ 204, 206 (Bd. App. 1961).

---SECTION---2173.05(o) Double Inclusion

While the concept that double inclusion of an element in members of a
Markush group recited in a claim is, per se, objectionable and renders a
claim indefinite is supported by some of the older cases like Ex parte
White, 759 O.G. 783 (Bd. App. 1958) and Ex parte Clark, 174 USPQ 40 (Bd.
App. 1971), other decisions clearly hold that there is no per se rule of
indefiniteness concerning overlapping members where alternatives are
recited in a claim, e.g., members of a Markush group. In re Kelly, 305
F.2d 909, 134 USPQ 397 (CCPA 1962).

The facts in each case must be evaluated to determine whether or not the
multiple inclusion of one or more elements in a claim gives rise to
indefiniteness in that claim. The mere fact that a compound may be
embraced by more than one member of a Markush group recited in the claim
does not lead to any uncertainty as to the scope of that claim for
either examination or infringement purposes. On the other hand, where a
claim directed to a device can be read to include the same element
twice, the claim may be indefinite. Ex parte Kristensen, 10 USPQ2d 1701
(Bd. Pat. App. & Inter. 1989).

---SECTION---2173.05(p) Claim Directed to Product-By- Process or Product
and Process

I. PRODUCT-BY-PROCESS

There are many situations where claims are permissively drafted to
include a reference to more than one statutory class of invention. A
product-by-process claim, which is a product claim that defines the
claimed product in terms of the process by which it is made, is proper.
In re Moeller, 117 F.2d 565, 48 USPQ 542 (CCPA 1941); In re Luck, 476
F.2d 650, 177 USPQ 523 (CCPA 1973); In re Steppan, 394 F.2d 1013, 156
USPQ 143 (CCPA 1967); and In re Pilkington, 411 F.2d 1345, 162 USPQ 145
(CCPA 1969). A claim to a device, apparatus, manufacture, or composition
of matter may contain a reference to the process in which it is intended
to be used without being objectionable under  35 U.S.C. 112, second
paragraph, so long as it is clear that the claim is directed to the
product and not the process.

The fact that it is necessary for an applicant to describe his product
in product-by-process terms does not prevent him from presenting claims
of varying scope. Ex parte Pantzer, 176 USPQ 141 (Bd. App. 1972).

II. PRODUCT AND PROCESS IN THE SAME CLAIM

A single claim which claims both an apparatus and the method steps of
using the apparatus is indefinite under  35 U.S.C. 112, second
paragraph. In Ex parte Lyell, 17 USPQ2d 1548 (Bd. Pat. App. & Inter.
1990), a claim directed to an automatic transmission workstand and the
method steps of using it was held to be ambiguous and properly rejected
under  35 U.S.C. 112, second paragraph.

Such claims should also be rejected under  35 U.S.C. 101 based on the
theory that the claim is directed to neither a "process" nor a
"machine," but rather embraces or overlaps two different statutory
classes of invention set forth in  35 U.S.C. 101 which is drafted so as
to set forth the statutory classes of invention in the alternative only.
Id. at 1551.

---SECTION---2173.05(q) "Use" Claims

Attempts to claim a process without setting forth any steps involved in
the process generally raises an issue of indefiniteness under  35 U.S.C.
112, second paragraph. For example, a claim which read: "A process for
using monoclonal antibodies of claim 4 to isolate and purify human
fibroblast interferon." was held to be indefinite because it merely
recites a use without any active, positive steps delimiting how this use
is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. &
Inter. 1986).

Other decisions suggest that a more appropriate basis for this type of
rejection is  35 U.S.C. 101. In Ex parte Dunki, 153 USPQ 678 (Bd. App.
1967), the Board held the following claim to be an improper definition
of a process: "The use of a high carbon austenitic iron alloy having a
proportion of free carbon as a vehicle brake part subject to stress by
sliding friction." In Clinical Products Ltd. v. Brenner, 255 F. Supp.
131, 149 USPQ 475 (D.D.C. 1966), the district court held the following
claim was definite, but that it was not a proper process claim under  35
U.S.C. 101: "The use of a sustained release therapeutic agent in the
body of ephedrine absorbed upon polystyrene sulfonic acid."

Although a claim should be interpreted in light of the specification
disclosure, it is generally considered improper to read limitations
contained in the specification into the claims. See In re Prater, 415
F.2d 1393, 162 USPQ 541 (CCPA 1969) and In re Winkhaus, 527 F.2d 637,
188 USPQ 129 (CCPA 1975), which discuss the premise that one cannot rely
on the specification to impart limitations to the claim that are not
recited in the claim.

A "USE" CLAIM SHOULD BE REJECTED UNDER ALTERNATIVE GROUNDS BASED ON 35
U.S.C 101 AND 112

In view of the split of authority as discussed above, the most
appropriate course of action would be to reject a "use" claim under
alternative grounds based on  35 U.S.C. 101 and 112.

BOARD HELD STEP OF "UTILIZING" WAS NOT INDEFINITE

It is often difficult to draw a fine line between what is permissible,
and what is objectionable from the perspective of whether a claim is
definite. In the case of Ex parte Porter, 25 USPQ2d 1144 (Bd. Pat. App.
& Inter. 1992), the Board held that a claim which clearly recited the
step of "utilizing" was not indefinite under  35 U.S.C. 112, second
paragraph. (Claim was to "A method for unloading nonpacked, nonbridging
and packed, bridging flowable particle catalyst and bead material from
the opened end of a reactor tube which comprises utilizing the nozzle of
claim 7.").

---SECTION---2173.05(r) Omnibus Claim

Some applications are filed with an omnibus claim which reads as
follows: A device substantially as shown and described. This claim
should be rejected under  35 U.S.C. 112, second paragraph because it is
indefinite in that it fails to point out what is included or excluded by
the claim language. See Ex parte Fressola, 27 USPQ2d 1608 (Bd. Pat. App.
& Inter. 1993), for a discussion of the history of omnibus claims and an
explanation of why omnibus claims do not comply with the requirements of 
35 U.S.C. 112, second paragraph.

Such a claim can be rejected using Form Paragraph 7.35.  See MPEP
Section  706.03(d).

For cancelation of such a claim by examiner's amendment, see MPEP
Section  1302.04(b).

---SECTION---2173.05(s) Reference to Figures or Tables

Where possible, claims are to be complete in themselves. Incorporation
by reference to a specific figure or table "is permitted only in
exceptional circumstances where there is no practical way to define the
invention in words and where it is more concise to incorporate by
reference than duplicating a drawing or table into the claim.
Incorporation by reference is a necessity doctrine, not for applicant's
convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. &
Inter. 1993) (citations omitted).

Reference characters corresponding to elements recited in the detailed
description and the drawings may be used in conjunction with the
recitation of the same element or group of elements in the claims. See
MPEP Section  608.01(m).

---SECTION---2173.05(t) Chemical Formula

Claims to chemical compounds and compositions containing chemical
compounds often use formulas that depict the chemical structure of the
compound. These structures should not be considered indefinite nor
speculative in the absence of evidence that the assigned formula is in
error. The absence of corroborating spectroscopic or other data cannot
be the basis for finding the structure indefinite. See Ex parte Morton,
134 USPQ 407 (Bd. App. 1961), and Ex parte Sobin, 139 USPQ 528 (Bd. App.
1962), in this regard.

A claim to a chemical compound is not indefinite merely because a
structure is not presented or because a partial structure is presented.
For example, the claim language at issue in In re Fisher, 427 F.2d 833,
166 USPQ 18 (CCPA 1970) referred to a chemical compound as a
"polypeptide of at least 24 amino acids having the following sequence."
A rejection under  35 U.S.C. 112, second paragraph for failure to
identify the entire structure was reversed and the court held: "While
the absence of such a limitation obviously broadens the claim and raises
questions of sufficiency of disclosure, it does not render the claim
indefinite." Chemical compounds may be claimed by a name that adequately
describes the material to one skilled in the art. See Martin v. Johnson,
454 F.2d 746, 172 USPQ 391 (CCPA 1972). A compound of unknown structure
may be claimed by a combination of physical and chemical
characteristics. See Ex parte Brian, 118 USPQ 242 (Bd. App. 1958). A
compound may also be claimed in terms of the process by which it is made
without raising an issue of indefiniteness.

---SECTION---2173.05(u) Trademarks or Trade Names in a Claim

The presence of a trademark or trade name in a claim is not, per se,
improper under  35 U.S.C. 112, second paragraph, but the claim should be
carefully analyzed to determine how the mark or name is used in the
claim. It is important to recognize that a trademark or trade name is
used to identify a source of goods, and not the goods themselves. Thus a
trademark or trade name does not identify or describe the goods
associated with the trademark or trade name. See definitions of
trademark and trade name in MPEP Section  608.01(v). A list of some
trademarks is found in Appendix I.

If the trademark or trade name is used in a claim as a limitation to
identify or describe a particular material or product, the claim does
not comply with the requirements of the  35 U.S.C. 112, second
paragraph. Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim
scope is uncertain since the trademark or trade name cannot be used
properly to identify any particular material or product. In fact, the
value of a trademark would be lost to the extent that it became
descriptive of a product, rather than used as an identification of a
source or origin of a product. Thus, the use of a trademark or trade
name in a claim to identify or describe a material or product would not
only render a claim indefinite, but would also constitute an improper
use of the trademark or trade name.

If a trademark or trade name appears in a claim and is not intended as a
limitation in the claim, the question of why it is in the claim should
be addressed. Does its presence in the claim cause confusion as to the
scope of the claim? If so, the claim should be rejected under  35 U.S.C.
112, second paragraph.

---SECTION---2173.05(v) Mere Function of Machine

In view of the decision of the Court of Customs and Patent Appeals in In
re Tarczy-Hornoch, 397 F.2d 856, 158 USPQ 141 (CCPA 1968), process or
method claims are not subject to rejection by Patent and Trademark
Office examiners under  35 U.S.C. 112, second paragraph, solely on the
ground that they define the inherent function of a disclosed machine or
apparatus. The court in Tarczy-Hornoch held that a process claim,
otherwise patentable, should not be rejected merely because the
application of which it is part discloses apparatus which will
inherently carry out the recited steps.

---SECTION---2173.06 Prior Art Rejection of Claim Rejected as Indefinite

All words in a claim must be considered in judging the patentability of
a claim against the prior art. In re Wilson, 424 F.2d 1382, 165 USPQ 494
(CCPA 1970). The fact that terms may be indefinite does not make the
claim obvious over the prior art. When the terms of a claim are
considered to be indefinite, at least two approaches to the examination
of an indefinite claim relative to the prior art are possible.

First, where the degree of uncertainty is not great, and where the claim
is subject to more than one interpretation and at least one
interpretation would render the claim unpatentable over the prior art,
an appropriate course of action would be for the examiner to enter two
rejections: (A) a rejection based on indefiniteness under  35 U.S.C.
112, second paragraph; and (B) a rejection over the prior art based on
the interpretation of the claims which renders the prior art applicable.
Ex parte Ionescu, 222 USPQ 537 (Bd. App. 1984). When making a rejection
over prior art in these circumstances, it is important for the examiner
to point out how the claim is being interpreted. Second, where there is
a great deal of confusion and uncertainty as to the proper
interpretation of the limitations of a claim, it would not be proper to
reject such a claim on the basis of prior art. As stated in In re
Steele, 305 F.2d 859, 134 USPQ 292 (CCPA 1962), a rejection under  35
U.S.C. 103 should not be based on considerable speculation about the
meaning of terms employed in a claim or assumptions that must be made as
to the scope of the claims.

The first approach is recommended from an examination standpoint because
it avoids piecemeal examination in the event that the examiner's  35
U.S.C. 112, second paragraph rejection is not affirmed, and may give
applicant a better appreciation for relevant prior art if the claims are
redrafted to avoid the  35 U.S.C. 112, second paragraph rejection.

---SECTION---2174 Relationship Between the Requirements of the First and
Second Paragraphs of 35 U.S.C. 112

The requirements of the first and second paragraphs of  35 U.S.C. 112
are separate and distinct. If a description or the enabling disclosure
of a specification is not commensurate in scope with the subject matter
encompassed by a claim, that fact alone does not render the claim
imprecise or indefinite or otherwise not in compliance with  35 U.S.C.
112, second paragraph; rather, the claim is based on an insufficient
disclosure (35 U.S.C. 112, first paragraph) and should be rejected on
that ground. In re Borkowski, 422 F.2d 904, 164 USPQ 642 (CCPA 1970). If
the specification discloses that a particular feature or element is
critical or essential to the practice of the invention, failure to
recite or include that particular feature or element in the claims may
provide a basis for a rejection based on the ground that those claims
are not supported by an enabling disclosure. In re Mayhew, 527 F.2d
1229, 188 USPQ 356 (CCPA 1976). In Mayhew, the examiner argued that the
only mode of operation of the process disclosed in the specification
involved the use of a cooling zone at a particular location in the
processing cycle. The claims were rejected because they failed to
specify either a cooling step or the location of the step in the
process. The court was convinced that the cooling bath and its location
were essential, and held that claims which failed to recite the use of a
cooling zone, specifically located, were not supported by an enabling
disclosure (35 U.S.C. 112, first paragraph).

In addition, if a claim is amended to include an invention that is not
described in the application as filed, a rejection of that claim under 
35 U.S.C. 112, first paragraph as being directed to subject matter that
is not described in the specification as filed may be appropriate.   In
re Simon, 302 F.2d 737, 133 USPQ 524 (CCPA 1962); In re Panagrossi, 277
F.2d 181, 125 USPQ 410 (CCPA 1960). In Simon, which involved a reissue
application containing claims to a reaction product of a composition,
applicant presented claims to a reaction product of a composition
comprising the subcombination A+B+C, whereas the original claims and
description of the invention were directed to a composition comprising
the combination A+B+C+D+E. The court found no significant support for
the argument that ingredients D+E were not essential to the claimed
reaction product and concluded that claims directed to the reaction
product of a subcombination A+B+C were not described (35 U.S.C. 112,
first paragraph) in the application as filed.

---SECTION---2181 Identifying a 35 U.S.C. 112, Sixth Paragraph
Limitation

The purpose of this section is to set forth guidelines for the
examination of  35 U.S.C. 112, sixth paragraph "means or step plus
function" limitations in a claim. The Court of Appeals for the Federal
Circuit, in its en banc decision In re Donaldson Co., 16 F.3d 1189, 29
USPQ2d 1845 (Fed. Cir. 1994), decided that a
"means-or-step-plus-function" limitation should be interpreted in a
manner different than patent examining practice had previously dictated.
The Donaldson decision affects only the manner in which the scope of a
"means or step plus function" limitation in accordance with  35 U.S.C.
112, sixth paragraph, is interpreted during examination.   Donaldson
does not directly affect the manner in which any other section of the
patent statutes is interpreted or applied.

When making a determination of patentability under  35 U.S.C. 102 or
103, past practice was to interpret a "means or step plus function"
limitation by giving it the "broadest reasonable interpretation." Under
the PTO's long-standing practice this meant interpreting such a
limitation as reading on any prior art means or step which performed the
function specified in the claim without regard for whether the prior art
means or step was equivalent to the corresponding structure, material or
acts described in the specification. However, in Donaldson, the Federal
Circuit stated:

Per our holding, the "broadest reasonable interpretation" that an
examiner may give means-plus-function language is that statutorily
mandated in paragraph six. Accordingly, the PTO may not disregard the
structure disclosed in the specification corresponding to such language
when rendering a patentability determination.

16 F.3d at 1195, 29 USPQ2d at 1850. Thus, examiners must interpret a  35
U.S.C. 112, sixth paragraph "means or step plus function" limitation in
a claim as limited to the corresponding structure, materials or acts
described in the specification and equivalents thereof in accordance
with the following guidelines.

LANGUAGE FALLING WITHIN 35 U.S.C. 112, SIXTH PARAGRAPH

In determining whether to apply the statutory procedures of  35 U.S.C.
112, sixth paragraph, the examiner must determine whether the applicant
intends to invoke the statutory mandates for step- or
means-plus-function clauses.  Although the use of the term "means,"
particularly "means for," generally invokes  35 U.S.C. 112, sixth
paragraph, and the use of a different formulation generally does not,
there is no particular language that must appear in a claim in order for
it to fall within the scope of  35 U.S.C. 112, sixth paragraph.
Greenberg v. Ethicon Endo-Surgery, Inc., 91 F.3d 1580, 1584, 39 USPQ2d
1783, 1786-87 (Fed. Cir. 1996).  However, it must be clear that the
element in the claim is set forth, at least in part, by the function it
performs as opposed to the specific structure, material, or acts that
perform the function. York Products Inc. v. Central Tractor Farm &
Family Center, 99 F.3d 1568, 1574, 40 USPQ2d 1619, 1624 (Fed. Cir. 1996)
("Without an identified function, the term `means' in this claim cannot
invoke 35 U.S.C. Section  112, paragraph 6.").  See also Caterpillar
Inc. v. Detroit Diesel Corp., 41 USPQ2d 1876, 1882 (N.D. Ind. 1996) (35
U.S.C. 112, sixth paragraph "applies to functional method claims where
the element at issue sets forth a step for reaching a particular result,
but not the specific technique or procedure used to achieve the
result.");   O.I. Corp. v. Tekmar Corp., 115 F.3d 1576, 1582-83, 42
USPQ2d 1777, 1782 (Fed. Cir. 1997) (With respect to process claims, "[
35 U.S.C. 112, sixth paragraph] is implicated only when steps plus
function without acts are present....  If we were to construe every
process claim containing steps described by an `ing' verb, such as
passing, heating, reacting, transferring, etc., into a
step-plus-function, we would be limiting process claims in a manner
never intended by Congress." (Emphasis in original).).  However, "the
fact that a particular mechanism . . . is defined in functional terms is
not sufficient to convert a claim element containing that term into a
`means for performing a specified function' within the meaning of
section 112(6)." Greenberg, 91 F.3d at 1583, 39 USPQ2d at 1786 ("detent
mechanism" defined in functional terms was not intended to invoke  35
U.S.C. 112, sixth paragraph). Also, a statement of function appearing
only in the claim preamble is generally insufficient to invoke  35
U.S.C. 112, sixth paragraph. O.I. Corp., 115 F.3d at 1583, 42 USPQ2d at
1782.  ("[A] statement in a preamble of a result that necessarily
follows from performing a series of steps does not convert each of those
steps into step-plus-function clauses. The steps of `passing' are not
individually associated in the claims with functions performed by the
steps of passing."). Although use of the term "means" in a clause
reciting predominantly structure does not evoke  35 U.S.C. 112, sixth
paragraph, York Products, 99 F.3d at 1574, 40 USPQ2d at 1623, "[t]he
recitation of some structure in a means plus function element does not
preclude applicability of section 112(6)." Laitram Corp. v. Rexnord,
Inc., 939 F.2d 1533, 1536, 19 USPQ2d 1367, 1369 (Fed. Cir. 1991).  It is
necessary to decide on an element by element basis whether  35 U.S.C.
112, sixth paragraph applies. Cole v. Kimberly-Clark Corp., 102 F.3d
524, 531, 41 USPQ2d 1001, 1006 (Fed. Cir. 1996) (term "perforation means
. . . for tearing" did not invoke  35 U.S.C. 112, sixth paragraph
because it recited a definite structure which performed the described
tearing function, as well as the location and extent of the structure). 
Each claim must be independently reviewed to determine the applicability
of  35 U.S.C. 112, sixth paragraph, even where the application contains
substantially similar process and apparatus claims. O.I. Corp., 115 F.3d
at 1583-1584, 42 USPQ2d at 1782. ("We understand that the steps in the
method claims are essentially in the same language as the limitations in
the apparatus claim, albeit without the `means for' qualification.... 
Each claim must be independently reviewed in order to determine if it is
subject to the requirements of section 112, &para;6.  Interpretation of
claims would be confusing indeed if claims that are not means- or step-
plus function were to be interpreted as if they were, only because they
use language similar to that used in other claims that are subject to
this provision."). Limitations that fall within the scope of  35 U.S.C.
112, sixth paragraph include:

(A) a jet driving device so constructed and located on the rotor as to
drive the rotor . . . ["means" unnecessary]. The term "device" coupled
with a function is a proper definition of structure in accordance with
the last paragraph of  35 U.S.C. 112. The addition of the words "jet
driving" to the term "device" merely renders the latter more definite
and specific. Ex parte Stanley, 121 USPQ 621 (Bd. App. 1958);

(B) "printing means" and "means for printing" which would have the same
connotations. Ex parte Klumb, 159 USPQ 694 (Bd. App. 1967). However, the
terms "plate" and "wing," as modifiers for the structureless term
"means," specify no function to be performed, and do not fall under the
last paragraph of  35 U.S.C. 112;

(C) force generating means adapted to provide . . . .   De Graffenreid
v. United States, 20 Ct. Cl. 458, 16 USPQ2d 1321 (Ct. Cl. 1990);

(D) call cost register means, including a digital display for providing
a substantially instantaneous display for . . . . Intellicall Inc. v.
Phonometrics, Inc., 952 F.2d 1384, 21 USPQ2d 1383 (Fed. Cir. 1992);

(E) reducing the coefficient of friction of the resulting film [step
plus function; "step" unnecessary], In re Roberts, 470 F.2d 1399, 176
USPQ 313 (CCPA 1973); and

(F) raising the pH of the resultant pulp to about 5.0 to precipitate . .
. . Ex parte Zimmerley, 153 USPQ 367 (Bd. App. 1966). In the event that
it is unclear whether the claim limitation falls within the scope of  35
U.S.C. 112, sixth paragraph, a rejection under  35 U.S.C. 112, second
paragraph may be appropriate.

SINGLE MEANS CLAIMS

Donaldson does not affect the holding of In re Hyatt, 708 F.2d 712, 218
USPQ 195 (Fed. Cir. 1983) to the effect that a single means claim does
not comply with the enablement requirement of  35 U.S.C. 112, first
paragraph. As Donaldson applies only to an interpretation of a
limitation drafted to correspond to  35 U.S.C. 112, sixth paragraph,
which by its terms is limited to "an element in a claim to a
combination," it does not affect a limitation in a claim which is not
directed to a combination.

---SECTION---2182 Scope of the Search and Identification of the Prior
Art

As noted in MPEP Section  2181, in In re Donaldson Co., 16 F.3d 1189, 29
USPQ2d 1845 (Fed. Cir. 1994) the Federal Circuit recognized that it is
important to retain the principle that claim language should be given
its broadest reasonable interpretation. This principle is important
because it helps insure that the statutory presumption of validity
attributed to each claim of an issued patent is warranted by the search
and examination conducted by the examiner. It is also important from the
standpoint that the scope of protection afforded by patents issued prior
to Donaldson are not unnecessarily limited by the latest interpretation
of this statutory provision. Finally, it is important from the
standpoint of avoiding the necessity for a patent specification to
become a catalogue of existing technology. A patent specification need
not teach, and preferably omits, what is well known in the art.
Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1384, 231
USPQ 81, 94 (Fed. Cir. 1986).

The Donaldson decision thus does not substantially alter examining
practice and procedure relative to the scope of the search. Both before
and after Donaldson, the application of a prior art reference to a means
or step plus function limitation requires that the prior art element
perform the identical function specified in the claim. However, if a
prior art reference teaches identity of function to that specified in a
claim, then under   Donaldson an examiner carries the initial burden of
proof for showing that the prior art structure or step is the same as or
equivalent to the structure, material, or acts described in the
specification which has been identified as corresponding to the claimed
means or step plus function.

The "means or step plus function" limitation should be interpreted in a
manner consistent with the specification disclosure. If the
specification defines what is meant by the limitation for the purposes
of the claimed invention, the examiner should interpret the limitation
as having that meaning. If no definition is provided, some judgment must
be exercised in determining the scope of the limitation.  See, e.g., B.
Braun Medical, Inc. v. Abbott Labs., 124 F.3d 1419, 1424, 43 USPQ2d
1896, 1900 (Fed. Cir. 1997) ("We hold that, pursuant to [ 35 U.S.C. 112,
sixth paragraph], structure disclosed in the specification is
`corresponding' structure only if the specification or prosecution
history clearly links or associates that structure to the function
recited in the claim.  This duty to link or associate structure to
function is the quid pro quo for the convenience of employing 112,
paragraph 6." The court refused to interpret a means-plus-function
limitation as corresponding to a disclosed valve seat structure, as
argued by patentee, since there was no indication in the specification
or prosecution history that this structure corresponds to the recited
function, and there was an explicitly clear association between that
function and a traverse cross section bar structure disclosed in the
specification.).

---SECTION---2183 Making a Prima Facie Case of   Equivalence

If the examiner finds that a prior art element performs the function
specified in the claim, and is not excluded by any explicit definition
provided in the specification for an equivalent, the examiner should
infer from that finding that the prior art element is an equivalent, and
should then conclude that the claimed limitation is anticipated by the
prior art element. The burden then shifts to applicant to show that the
element shown in the prior art is not an equivalent of the structure,
material or acts disclosed in the application. In re Mulder, 716 F.2d
1542, 219 USPQ 189 (Fed. Cir. 1983). No further analysis of equivalents
is required of the examiner until applicant disagrees with the
examiner's conclusion, and provides reasons why the prior art element
should not be considered an equivalent. See also, In re Walter, 618 F.2d
758, 768, 205 USPQ 397, 407-08 (CCPA 1980) (a case treating  35 U.S.C.
112, sixth paragraph, in the context of a determination of statutory
subject matter and noting "If the functionally-defined disclosed means
and their equivalents are so broad that they encompass any and every
means for performing the recited functions . . . the burden must be
placed on the applicant to demonstrate that the claims are truly drawn
to specific apparatus distinct from other apparatus capable of
performing the identical functions"); In re Swinehart, 439 F.2d 210,
212-13, 169 USPQ 226, 229 (CCPA 1971) (a case in which the court treated
as improper a rejection under  35 U.S.C. 112, second paragraph, of
functional language, but noted that "where the Patent Office has reason
to believe that a functional limitation asserted to be critical for
establishing novelty in the claimed subject matter may, in fact, be an
inherent characteristic of the prior art, it possesses the authority to
require the applicant to prove that the subject matter shown to be in
the prior art does not possess the characteristics relied on"); and In
re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980) (a case indicating
that the burden of proof can be shifted to the applicant to show that
the subject matter of the prior art does not possess the characteristic
relied on whether the rejection is based on inherency under  35 U.S.C.
102 or obviousness under  35 U.S.C. 103).

See MPEP Section  2184 for the factors to be considered when determining
whether the applicant has successfully met the burden of proving that
the prior art element is not equivalent to the structure, material or
acts described in the applicant's specification.

IF NONEQUIVALENCE SHOWN, EXAMINER MUST CONSIDER OBVIOUSNESS

However, even where the applicant has met that burden of proof and has
shown that the prior art element is not equivalent to the structure,
material or acts described in the applicant's specification, the
examiner must still make a  35 U.S.C. 103 analysis to determine if the
claimed means or step plus function is obvious from the prior art to one
of ordinary skill in the art. Thus, while a finding of nonequivalence
prevents a prior art element from anticipating a means or step plus
function limitation in a claim, it does not prevent the prior art
element from rendering the claim limitation obvious to one of ordinary
skill in the art. Because the exact scope of an "equivalent" may be
uncertain, it would be appropriate to apply a  35 U.S.C. 102/103
rejection where the balance of the claim limitations are anticipated by
the prior art relied on. A similar approach is authorized in the case of
product-by-process claims because the exact identity of the claimed
product or the prior art product cannot be determined by the examiner.
In re Brown, 450 F.2d 531, 173 USPQ 685 (CCPA 1972). In addition,
although it is normally the best practice to rely on only the best prior
art references in rejecting a claim, alternative grounds of rejection
may be appropriate where the prior art shows elements that are different
from each other, and different from the specific structure, material or
acts described in the specification, yet perform the function specified
in the claim.

---SECTION---2184 Determining Whether an Applicant Has Met the Burden of
Proving Nonequivalence After a Prima Facie Case Is Made

If the applicant disagrees with the inference of equivalence drawn from
a prior art reference, the applicant may provide reasons why the
applicant believes the prior art element should not be considered an
equivalent to the specific structure, material or acts disclosed in the
specification. Such reasons may include, but are not limited to:

(A) Teachings in the specification that particular prior art is not
equivalent;

(B) Teachings in the prior art reference itself that may tend to show
nonequivalence; or

(C) 37 CFR 1.132 affidavit evidence of facts tending to show
nonequivalence.

TEACHINGS IN APPLICANT'S SPECIFICATION

When the applicant relies on teachings in applicant's own specification,
the examiner must make sure that the applicant is interpreting the
"means or step plus function" limitation in the claim in a manner which
is consistent with the disclosure in the specification. If the
specification defines what is meant by "equivalents" to the disclosed
embodiments for the purpose of the claimed means or step plus function,
the examiner should interpret the limitation as having that meaning. If
no definition is provided, some judgment must be exercised in
determining the scope of "equivalents." Generally, an "equivalent" is
interpreted as embracing more than the specific elements described in
the specification for performing the specified function, but less than
any element that performs the function specified in the claim. To
interpret "means plus function" limitations as limited to a particular
means set forth in the specification would nullify the provisions of  35
U.S.C. 112 requiring that the limitation shall be construed to cover the
structure described in the specification and equivalents thereof.
D.M.I., Inc. v. Deere & Co., 755 F.2d 1570, 1574, 225 USPQ 236, 238
(Fed. Cir. 1985).

The scope of equivalents embraced by a claim limitation is dependent on
the interpretation of an "equivalent." The interpretation will vary
depending on how the element is described in the supporting
specification. The claim may or may not be limited to particular
structure, material or acts (e.g., steps) as opposed to any and all
structure, material or acts performing the claimed function, depending
on how the specification treats that question.

If the disclosure is so broad as to encompass any and all structure,
material or acts for performing the claimed function, the claims must be
read accordingly when determining patentability. When this happens the
limitation otherwise provided by "equivalents" ceases to be a limitation
on the scope of the claim in that an equivalent would be any structure,
material or act other than the ones described in the specification that
perform the claimed function. For example, this situation will often be
found in cases where (A) the claimed invention is a combination of
elements, one or more of which are selected from elements that are old,
per se, or (B) apparatus claims are treated as indistinguishable from
method claims. See, for example, In re Meyer, 688 F.2d 789, 215 USPQ 193
(CCPA 1982); In re Abele, 684 F.2d 902, 909, 214 USPQ 682, 688 (CCPA
1982); In re Walter, 618 F.2d 758, 767, 205 USPQ 397, 406-07 (CCPA
1980); In re Maucorps, 609 F.2d 481, 203 USPQ 812 (CCPA 1979); In re
Johnson, 589 F.2d 1070, 200 USPQ 199 (CCPA 1978); and In re Freeman, 573
F.2d 1237, 1246, 197 USPQ 464, 471 (CCPA 1978).

On the other end of the spectrum, the "equivalents" limitation as
applied to a claim may also operate to constrict the claim scope to the
point of covering virtually only the disclosed embodiments. This can
happen in circumstances where the specification describes the invention
only in the context of a specific structure, material or act that is
used to perform the function specified in the claim.

FACTORS TO BE CONSIDERED IN DECIDING EQUIVALENCE

When deciding whether an applicant has met the burden of proof with
respect to showing nonequivalence of a prior art element that performs
the claimed function, the following factors may be considered. First,
unless an element performs the identical function specified in the
claim, it cannot be an equivalent for the purposes of  35 U.S.C. 112,
sixth paragraph. Pennwalt Corp. v. Durand-Wayland, Inc., 833 F.2d 931, 4
USPQ2d 1737 (Fed. Cir. 1987), cert. denied, 484 U.S. 961 (1988).

Second, while there is no litmus test for an "equivalent" that can be
applied with absolute certainty and predictability, there are several
indicia that are sufficient to support a conclusion that one element is
or is not an "equivalent" of a different element in the context of  35
U.S.C. 112, sixth paragraph. Among the indicia that will support a
conclusion that one element is or is not an equivalent of another are:

(A) Whether the prior art element performs the function specified in the
claim in substantially the same way, and produces substantially the same
results as the corresponding element disclosed in the specification.
Lockheed Aircraft Corp. v. United States, 193 USPQ 449, 461 (Ct. Cl.
1977). The concepts of equivalents as set forth in Graver Tank & Mfg.
Co. v. Linde Air Products, 339 U.S. 605, 85 USPQ 328 (1950) are relevant
to any "equivalents" determination. Polumbo v. Don-Joy Co., 762 F.2d
969, 975, n. 4, 226 USPQ 5, 8-9, n. 4 (Fed. Cir. 1985).

(B) Whether a person of ordinary skill in the art would have recognized
the interchangeability of the element shown in the prior art for the
corresponding element disclosed in the specification. Lockheed Aircraft
Corp. v. United States, 193 USPQ 449, 461 (Ct. Cl. 1977); Data Line
Corp. v. Micro Technologies, Inc., 813 F.2d 1196, 1 USPQ2d 2052 (Fed.
Cir. 1987).

(C) Whether the prior art element is a structural equivalent of the
corresponding element disclosed in the specification being examined. In
re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990). That is, the
prior art element performs the function specified in the claim in
substantially the same manner as the function is performed by the
corresponding element described in the specification.

(D) Whether there are insubstantial differences between the prior art
element and the structure, material or acts disclosed in the
specification. Warner-Jenkinson Co. v. Hilton Davis Chemical Co., 117 S.
Ct. 1040, 41 USPQ2d 1865, 1875 (1997);   Valmont Industries, Inc. v.
Reinke Mfg. Co., 983 F.2d 1039, 25 USPQ2d 1451 (Fed. Cir. 1993).

These examples are not intended to be an exhaustive list of the indicia
that would support a finding that one element is or is not an equivalent
of another element for the purposes of  35 U.S.C. 112, sixth paragraph.
A finding according to any of the above examples would represent a
sufficient, but not the only possible, basis to support a conclusion
that an element is or is not an equivalent. There could be other indicia
that also would support the conclusion.

MERE ALLEGATIONS OF NONEQUIVALENCE ARE NOT SUFFICIENT

In determining whether arguments or  37 CFR 1.132 evidence presented by
an applicant are persuasive that the element shown in the prior art is
not an equivalent, the examiner should consider and weigh as many of the
above-indicated or other indicia as are presented by applicant, and
should determine whether, on balance, the applicant has met the burden
of proof to show nonequivalence. However, under no circumstance should
an examiner accept as persuasive a bare statement or opinion that the
element shown in the prior art is not an equivalent embraced by the
claim limitation. Moreover, if an applicant argues that the "means" or
"step" plus function language in a claim is limited to certain specific
structural or additional functional characteristics (as opposed to
"equivalents" thereof) where the specification does not describe the
invention as being only those specific characteristics, the claim should
not be allowed until the claim is amended to recite those specific
structural or additional functional characteristics. Otherwise, a claim
could be allowed having broad functional language which, in reality, is
limited to only the specific structure or steps disclosed in the
specification. This would be contrary to public policy of granting
patents which provide adequate notice to the public as to a claim's true
scope.

APPLICANT MAY AMEND CLAIMS

Finally, as in the past, applicant has the opportunity during
proceedings before the Office to amend the claims so that the claimed
invention meets all the statutory criteria for patentability. An
applicant may choose to amend the claim by further limiting the function
so that there is no longer identity of function with that taught by the
prior art element, or the applicant may choose to replace the claimed
means plus function limitation with specific structure, material or acts
that are not described in the prior art.

---SECTION---2185 Related Issues Under 35 U.S.C. 112, First or Second
Paragraphs

Interpretation of claims as set forth in MPEP Section  2181 may create
some uncertainty as to what applicant regards as the invention. If this
issue arises, it should be addressed in a rejection under  35 U.S.C.
112, second paragraph. While  35 U.S.C. 112, sixth paragraph permits a
particular form of claim limitation, it cannot be read as creating an
exception either to the description, enablement or best mode
requirements of the first paragraph or the definiteness requirement of
the second paragraph of  35 U.S.C. 112. In re Knowlton, 481 F.2d 1357,
178 USPQ 486 (CCPA 1973).

If a "means or step plus function" limitation recited in a claim is not
supported by corresponding structure, material or acts in the
specification disclosure, the following rejections should be considered:

(A) under  35 U.S.C. 112, first paragraph, as not being supported by an
enabling disclosure because the person skilled in the art would not know
how to make and use the invention without a description of elements to
perform the function. The description of an apparatus with block
diagrams describing the function, but not the structure, of the
apparatus is not fatal under the enablement requirement of  35 U.S.C.
112, first paragraph, as long as the structure is conventional and can
be determined without an undue amount of experimentation. In re Ghiron,
442 F.2d 985, 991, 169 USPQ 723, 727 (CCPA 1971);

(B) under  35 U.S.C. 112, second paragraph, as being indefinite. In re
Dossel, 115 F.3d 942, 946, 42 USPQ2d 1881, 1884 (Fed. Cir. 1997); and

(C) under  35 U.S.C. 102 or 103 where the prior art anticipates or
renders obvious the claimed subject matter including the means or step
that performs the function specified in the claim, the theory being that
since there is no corresponding structure, etc., in the specification to
limit the means or step plus function limitation, an equivalent is any
element that performs the specified function.

---SECTION---2186 Relationship to the Doctrine of Equivalents

The doctrine of equivalents arises in the context of an infringement
action.  If an accused product or process does not literally infringe a
patented invention, the accused product or process may be found to
infringe under the doctrine of equivalents.  The essential objective
inquiry is:  "Does the accused product or process contain elements
identical or equivalent to each claimed element of the patented
invention?" Warner-Jenkinson Co. v. Hilton Davis Chemical Co., 117 S.
Ct. 1040, 41 USPQ2d 1865, 1875 (1997). In determining equivalence, "[a]n
analysis of the role played by each element in the context of the
specific patent claim will thus inform the inquiry as to whether a
substitute element matches the function, way, and result of the claimed
element, or whether the substitute plays a role substantially different
from the claimed element." 41 USPQ2d at 1875.

35 U.S.C. 112, sixth paragraph permits "means or step plus function"
limitations in claims to combinations, "with the proviso that
application of the broad literal language of such claims must be limited
to only those means that are `equivalent' to the actual means shown in
the patent specification. This is an application of the doctrine of
equivalents in a restrictive role, narrowing the application of broad
literal claim elements." 41 USPQ2d at 1870. Accordingly, decisions
involving the doctrine of equivalents should be considered, but should
not unduly influence a determination under  35 U.S.C. 112, sixth
paragraph during ex parte examination.

