[Federal Register Volume 62, Number 28 (Tuesday, February 11, 1997)]
[Notices]
[Pages 6217-6224]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-3362]
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DEPARTMENT OF COMMERCE
Patent and Trademark Office
[Docket No. 970129014-7014-01]
RIN 0651-XX09
Interim Guidelines for the Examination of Claims Directed to
Species of Chemical Compositions Based Upon a Single Prior Art
Reference
AGENCY: Patent and Trademark Office, Commerce.
ACTION: Notice.
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SUMMARY: The Patent and Trademark Office (PTO) requests comments from
any interested member of the public on interim guidelines to be used by
office personnel in their review of patent applications which contain
claims directed to a species or subgenus of chemical compositions for
compliance with 35 U.S.C. 103 based upon a single prior art reference
which discloses a genus embracing the claimed species or subgenus but
does not expressly describe the particular claimed species or subgenus.
DATES: The interim guidelines are effective February 11, 1997.
Written comments on the interim guidelines will be accepted by the
PTO until April 14, 1997.
ADDRESSES: Written comments should be addressed to the attention of
Linda Moncys Isacson, Office of the Solicitor, P.O. Box 15667,
Arlington, Virginia 22215 or to Linda S. Therkorn, Box Comments,
Assistant Commissioner for Patents, Washington, DC. 20231, or by
facsimile transmission to (703) 305-9373 or by electronic mail to
[email protected].
Written comments will be made available for public inspection at
the Patent Search Room, Crystal Plaza 3, 2021 South Clark Place,
Arlington, VA. In addition, comments provided in machine-readable
format will be available through the PTO's Website at http://
www.uspto.gov.
FOR FURTHER INFORMATION CONTACT: Linda Moncys Isacson, Office of the
Solicitor, P.O. Box 15667, Arlington, Virginia 22215 or Linda S.
Therkorn, Box Comments, Assistant Commissioner for Patents, Washington,
DC. 20231, or by facsimile transmission to (703) 305-9373 or by
electronic mail to [email protected].
SUPPLEMENTARY INFORMATION: The Commissioner of Patents and Trademarks
issued a Notice in the Official Gazette (O.G.) on April 17, 1995 (1174
O.G. 68), withdrawing the Office's March 22, 1994 O.G. Notice (1161
O.G. 314). Both notices were entitled ``In re Baird.'' Pursuant to the
April 17, 1995 O.G. Notice, the following interim examination
guidelines are being published for public comment. The purpose of these
guidelines is to assist PTO personnel in the examination of
applications which contain claims directed to a species or subgenus of
chemical compositions for compliance with 35 U.S.C. 103 based upon a
single prior art reference which discloses a genus embracing the
claimed species or subgenus but does not expressly describe the
particular claimed species or subgenus. Thereof, these interim
guidelines will be referred to as ``Genus-Species Guidelines.''
It has been determined that these interim guidelines are not a
significant rule for purposes of Executive Order 12866. Because these
guidelines govern internal practices, they are exempt from notice and
comment rulemaking under 5 U.S.C. 553(b)(A).
Members of the public may present written comments on these
guidelines. Written comments should include the following information:
--Name and affiliation of the individual responding;
--An indication of whether the comments offered represent views of the
respondent's organization or are the respondent's personal views; and
--If applicable, information on the respondent's organization,
including the type of organization (e.g., business, trade group,
university, nonprofit organization).
The PTO is particularly interested in comments relating to the
accuracy of the emphasized prior art teachings, and comments
identifying any additional teachings that should be emphasized in
determining whether a prima facie case of obviousness exists in the
types of cases covered by these interim guidelines. The PTO is also
interested in comments relating to the effect these guidelines may have
on future application submissions.
[[Page 6218]]
Dated: February 5, 1997.
Bruce A. Lehman,
Assistant Secretary of Commerce and Commissioner of Patents and
Trademarks.
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.\1\ Next, Office
personnel should conduct a thorough search of the prior art and
identify all relevant references.\2\ 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.\3\ 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.\4\ 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.\5\
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.\6\
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.\7\ 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.\8\
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.\9\
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.\10\
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.\11\ These disclosed
findings should be made with a complete understanding of the first
three ``Graham factors.'' \12\ Thus, Office personnel should (1)
determine the ``scope and content of the prior art''; (2) ascertain the
``differences between the prior art and the claims at issue''; and (3)
determine ``the level of ordinary skill in the pertinent art.'' \13\
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,\14\ and should be in the field of
applicant's endeavor, or be reasonably pertinent to the particular
problem with which the inventor was concerned.\15\
In the case of a prior art reference disclosing a genus, Office
personnel should make findings as to (1) the structure of the disclosed
prior art genus and that of any expressly described species or subgenus
within the genus; (2) 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; (3) the predictability of the technology; and (4) 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.\16\
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.\17\ 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.
[[Page 6219]]
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 hole, i.e., to select the claimed species or subgenus from the
disclosed prior art genus.\18\ 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.\19\ There is no absolute correlation between the
size of the prior art genus and a conclusion of obviousness.\20\ 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.\21\
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.\22\
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.\23\
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,\24\ based on the reasonable expectation that
structurally similar species usually have similar properties.\25\ The
utility of such properties will normally provide some motivation to
make the claimed species or subgenus.\26\
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.\27\ 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.\28\
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.\29\ 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.\30\
Concepts used to analyze the structural similarity of chemical
compounds in other types of chemical cases are equally useful in
analyzing genus-species cases.\31\ Generally, some teaching of a
structural similarity will be necessary to suggest selection of the
claimed species or subgenus\32\
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.\33\ Conversely, lack of
any known useful properties weighs against a finding of motivation to
make or select a species or subgenus.\34\ However, the prior art need
not disclose a newly discovered property in order for there to be a
prima facie case of obviousness.\35\ 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.\36\ 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.\37\
In fact, similar properties may normally be presumed when compounds are
very close in structure.\38\ Thus, evidence of similar properties
weighs in favor of a conclusion that the claimed invention would have
been obvious.\39\
e. Consider the Predictability of the Technology. Consider the
predictability of the technology.\40\ 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.\41\ However,
obviousness does not require absolute predictability, only a reasonable
expectation of success, i.e., a reasonable expectation of obtaining
similar properties.\42\
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,\43\ 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.\4\ 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.\45\ Rebuttal evidence and arguments can
be presented in the specification,\46\ by counsel,\47\ or by way of an
affidavit or declaration under 37 CFR 1.132.\48\ However, arguments of
counsel cannot take the place of factually supported objective
evidence.\49\
Office personnel should consider all rebuttal arguments and
evidence presented by applicants.\50\ Rebuttal evidence may include
evidence of ``secondary consideration,'' such as ``commercial success,
long felt but unsolved needs, (and) failure of others,'' \51\ evidence
that the claimed invention yields unexpectedly improved properties or
properties not present in the prior art,\52\ or evidence that the
claimed invention was copied
[[Page 6220]]
by others.\53\ 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.\54\
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.\55\ However, to be entitled to substantial weight the
applicant should establish a nexus between the rebuttal evidence and
the claimed invention,\56\ i.e., objective evidence of nonobviousness
must be attributable to the claimed invention.\57\ Additionally, the
evidence must be reasonably commensurate in scope with the claimed
invention.\58\ 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.\59\ On the other
hand, evidence of an unexpected property may not be sufficient
regardless of the scope of the showing.\60\ 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 cases \61\ 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.\62\ Thus, once
the applicant has presented rebuttal evidence, Office personnel should
reconsider any initial obviousness determination in view of the entire
record.\63\ 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.\64\ Conclusory statements of similarity or motivation,
without any articulated rationale or evidentiary support, do not
constitute sufficient factual findings.
VI. Footnotes
1. When evaluating the scope of a claim, every limitation in the
claim must be considered. 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. 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' '').
2. 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.
3. ``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).
4. 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).
5. 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).
6. 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).
7. 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: (1) Determine the
scope and contents of the prior art; (2) ascertain the differences
between the prior art and the claims in issue; (3) determine the
level of skill in the pertinent art; and (4) evaluate any evidence
of secondary considerations.
8. 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.
9. Id.
10. 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.'').
11. 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. 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).
12. 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 exists should be made on
the full record before the Office at the time of the determination.
13. 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).
14. E.g., Panduit Corp. v. Dennison Mfg. Co., 810 F.2d 1561,
1568, 1 USPQ2d 1593, 1597 (Fed. Cir.) (``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. Sec. 102.''), cert. denied, 481
U.S. 1052 (1987).
15. 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).
16. 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. 103 is not whether the differences [between
the claimed invention and the prior art] would have been obvious''
but ``whether the claimed invention
[[Page 6221]]
as a whole would have been obvious.'' (emphasis in original).
17. See, Ryko Manufacturing 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).
18. 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).
19. 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'').
20. Id.
21. 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
10\36\ 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.'').
22. 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.).
23. 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 co-administered 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).
24. E.g., Dillon, 919 F.2d at 696, 16 USPQ2d at 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.'').
25. E.g., Dillion, 919 F.2d at 693, 16 USPQ2d at 1901.
26. See id.
27. 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).
28. E.g., Dillion, 919 F.2d at 696, 16 USPQ2d at 1904 (and cases
cited therein). C.f. Baird, 16 F.3d at 382-83, 29 USPQ2d at 1552
(disclosure of dissimilar species can provide teaching away).
29. 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).
30. 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).
31. 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. Dillion, 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, No. 95-
1522, slip op. at 6-8 (Fed. Cir. Jan. 17, 1997).
Other structural similarities have been found to support a prima
facie case of obviousness. 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).
32. Id.
33. Dillion, 919 F.2d at 697, 16 USPQ2d at 1905; In re
Stemniski, 444 F.2d 581, 586, 170 USPQ 343, 348 (CCPA 1971).
34. 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.).
[[Page 6222]]
35. Dillion, 919 F.2d at 697, 16 USPQ2d at 1904-05 (and cases
cited therein).
36. E.g., id.
37. Id. at 692, 16 USPQ2d at 1900-01.
38. Dillion, 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.'').
39. Dillion, 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).
40. See, e.g., Dillion, 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).
41. 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).
42. See, e.g., In re O'Farrell, 853 F.2d 894, 903, 7 USPQ2d
1673, 1681 (Fed. Cir. 1988).
43. 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).
44. 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).
45. E.g., Dillon, 919 F.2d at 692, 16 USPQ2d at 1901.
46. In re Soni, 54 F. 3d 746, 750, 34 USPQ2d 1684, 1687 (Fed.
Cir. 1995).
47. In re Chu, 66 F.3d 292, 299, 36 USPQ2d 1089, 1094-95 (Fed.
Cir. 1995).
48. E.g., Soni, 54 F.3d at 750, 34 USPQ2d 1687; In re Piasecki,
745 F.2d 1468, 1474, 223, USPQ 785, 789-90 (Fed. Cir. 1984).
49. 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).
50. 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 UPSPQ2d 1578
(Fed. Cir. 1996) (error not to consider factual evidence submitted
to counter a section 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
intention.); 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.'').
51. Graham v. John Deere Co., 383 U.S. at 17, 148 USPQ at 467.
See also, e.g., In re Piasecki, 745 F.2d at 1468, 1473, 223 USPQ
785, 788 (Fed. Cir. 1984) (commercial success).
52. 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, No. 95-1522,
slip op. at 9-10 (Fed. Cir. Jan. 17, 1997) (conclusory statements
that claimed compound posses unusually low immune response or
unexpected biological activity that is unsupported by comparative
data held insufficient to overcome prima facie case of obviousness).
53. 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).
54. 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
non-technological 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.).
55. Id. See also In re Alton, 76 F.3d 1168, 1174-75, 37 USPQ2d
1578, 1582-83 (Fed. Cir. 1996).
56. 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).
57. E.G., Paulsen, 30 F.3d at 1482, 31 USPQ2d at 1676. (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).
58. 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 non-
obviousness 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.
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).
[[Page 6223]]
59. E.g., Chupp, 816 F.2d at 646, 2 USPQ2d at 1439; Clemens, 622
F.2d at 1036, 206 USPQ at 296.
60. 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.
61. Piasecki, 745 F.2d at 1473, 223 USPQ at 788.
62. 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).
63. E.g., Piasecki, 745 F.2d at 1472, 223 USPQ at 788; Eli
Lilly, 902 F.2d at 945, 14 USPQ2d at 1743.
64. 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).
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