[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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).

BILLING CODE 3510-16-M
      

[[Page 6224]]

[GRAPHIC] [TIFF OMITTED] TN11FE97.000



[FR Doc. 97-3362 Filed 2-10-97; 8:45 am]
BILLING CODE 3510-16-C