[Federal Register Volume 63, Number 171 (Thursday, September 3, 1998)]
[Notices]
[Pages 47000-47007]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-23681]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office
[Docket No. 970129014-8206-02]
RIN 0651-XX09


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) is publishing the final 
version of guidelines to be used by Office personnel in reviewing a 
certain type of patent application for compliance with 35 U.S.C. 103. 
The guidelines are to be used when examining claims directed to a 
species or subgenus of chemical compositions when: (1) the claims have 
been rejected based upon a single prior art reference, and (2) the 
single prior art reference discloses a genus embracing the claimed 
species or subgenus but does not expressly describe the particular 
claimed species or subgenus. Because these guidelines govern internal 
practices, they are exempt from notice and comment rulemaking under 5 
U.S.C. 553(b)(A).

DATES: The guidelines are effective September 3, 1998.

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, 
D.C. 20231, or by facsimile transmission to (703) 305-9373 or by 
electronic mail over the Internet to [email protected].

SUPPLEMENTARY INFORMATION:

[[Page 47001]]

Discussion of Public Comments

    Comments were received by the PTO from two different individuals 
and one organization in response to the Request for Comments on the 
Interim Guidelines for the Examination of Claims Directed to Species of 
Chemical Compositions Based Upon a Single Prior Art Reference published 
February 11, 1997 (62 FR 6217). All comments have been carefully 
considered.
    The following comments have been substantively adopted to effect 
changes in the guidelines:
    (1) A suggestion to annotate the flowchart with references to 
corresponding sections of text in the guidelines was adopted.
    (2) One comment suggested that the guidelines inappropriately 
focussed solely on the number of possible members of a prior art genus 
to determine whether the prior art genus anticipated a claimed species 
or subgenus. Attention was drawn to the discussion of In re Petering, 
301 F.2d 676, 133 USPQ 275 (CCPA 1962) in the text at section II.A.4.a 
and note 22, which seemed to suggest that size of the genus alone was 
sufficient to support a finding of anticipation. These portions of the 
guidelines have been modified to indicate that size of the genus is 
only one factor to be considered in determining anticipation.
    (3) One comment suggested that the guidelines be supplemented to 
direct Office personnel to consider the sufficiency of the preparative 
methods disclosed in the cited reference. Failure of a prior art 
reference to disclose or render obvious a method for making any 
composition of matter may preclude a conclusion that the composition 
would have been obvious if the disclosure is not enabling. However, 
once a prima facie case of obviousness is made out by the PTO, the 
initial burden of going forward with evidence to show that no process 
was known in the art for preparing the compound is on the applicant. 
Accordingly, the guidelines have been changed at section II.B to 
include consideration of sufficiency of disclosure of preparative 
methods as rebuttal evidence to overcome a prima facie case of 
obviousness.
    (4) One comment suggested that the language in section II.A.2 of 
the guidelines and in corresponding portions of the flowchart 
instructing Office personnel to make explicit findings on the 
similarities and differences between ``the closest prior art 
reference'' and the claimed species or subgenus be changed to direct 
findings to be made between the ``closest disclosed species or 
subgenus'' and the claimed species or subgenus for accuracy and 
clarity. This change has been made in the text.
    (5) One comment suggested that section II.A.4.d be clarified to 
indicate that the utility disclosed in a reference need not be the same 
as the stated utility of the claimed compound. Language has been added 
to indicate that any useful property may be the basis of a finding of 
motivation.
    (6) One comment suggested that language in section II.B. stating 
that evidence of an unexpected property may not be sufficient to 
overcome a prima facie case of obviousness, regardless of the scope of 
the showing, is not accurate in view of the law. Language has been 
added to the associated footnote to clarify that a showing of an 
unexpected property is sufficient in most circumstances.
    The following comments have been considered but have not been 
adopted for the reasons discussed below:
    (1) One comment suggested that more emphasis be placed on 
additional references which may teach away from the claimed compound(s) 
due to a disclosure of related compounds having or expected to have 
disadvantages not possessed by the claimed compound(s). This comment 
was not adopted because it focuses on ``additional references,'' 
whereas the scope of these guidelines is directed to situations 
involving rejections over a single reference. The guidelines already 
clearly instruct Office personnel that they must consider any 
additional references or evidence of teaching away that are present.
    (2) One comment suggested that the guidelines were too limited in 
scope because they focused on rejections based on a single reference as 
opposed to rejections based on more than one reference. The scope of 
these guidelines is intended to address a specific issue, i.e., the 
situation where only one reference disclosing a genus but not the 
claimed species is found. Although the principles discussed in these 
guidelines are generally applicable to all rejections under 35 U.S.C. 
103, the explicit scope of these guidelines will not be changed.
    (3) One comment suggested that section II.A.4.f of the guidelines 
inappropriately instructs Office personnel to focus only on evidence 
supporting a rejection rather than making a complete analysis. Section 
II.A.4.f of the guidelines additionally instructs Office personnel to 
consider the totality of the evidence in each case. Furthermore, Office 
personnel are instructed in section II.B to consider whether rebuttal 
evidence overcomes a prima facie case of obviousness and in section III 
to reconsider all evidence in reaching a conclusion. Thus, the 
guidelines presently clearly require all evidence to be considered, not 
only evidence supporting a rejection.
    (4) One comment suggested that the last sentence of section 
II.A.4.c assumes that a generic teaching in a reference, by itself, is 
never enough to make out a prima facie case of obviousness. The 
referenced language does not suggest this, but rather it merely states 
the general proposition that in most cases, additional teachings of 
structural similarity to the disclosed species or subgenus are 
necessary. Accordingly, no change has been made.
    (5) One comment suggested that the guidelines address the 
significance of the type of reference involved, i.e. whether there is a 
difference between a journal publication, a U.S. Patent, a foreign 
patent, etc. This suggestion has not been adopted, because for 
substantive analysis under 35 U.S.C. 103, each reference should be 
considered for all of its teachings, regardless of its form.
    (6) One comment suggested that the guidelines address the 
significance of the presence or absence of any activity testing of 
disclosed species in the reference. The guidelines already instruct 
Office personnel to consider any teachings of similar properties or 
uses, predictability of the technology, and any other teachings present 
in the reference that would support selection of the claimed compound. 
Consideration of any disclosed testing data is subsumed in these 
considerations.

I. 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

[[Page 47002]]

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 appropriate antecedent 
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.*
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    \*\ Footnotes at end of docket.
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    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 Closest Disclosed Prior Art 
Species or Subgenus of Record and the Claimed Species or Subgenus
    Once the structure of the disclosed prior art genus and that of any 
expressly described species or subgenus within the genus are 
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 disclosed prior art species or subgenus of record 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.
4. Determine Whether One of Ordinary Skill in the Art Would Have Been 
Motivated To Select the Claimed Species or Subgenus
    In light of the findings made relating to the three Graham factors, 
Office personnel should determine whether one of ordinary skill in the 
relevant art would have been motivated to make the claimed invention as 
a whole, i.e., to select the claimed species or subgenus from the 
disclosed prior art genus.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, when considered in light of the totality of the 
circumstances, it

[[Page 47003]]

would anticipate the claimed species or subgenus. For example, it has 
been held that a prior art genus containing only 20 compounds and a 
limited number of variations in the generic chemical formula 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 any 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-ortho ester and a tetra-ortho ester 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 or evidence of any useful properties 
disclosed in the prior art that would be expected to be shared by the 
claimed invention 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.44 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 Sec. 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 considerations,'' 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 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 For example, rebuttal evidence may include a 
showing that the prior art fails to disclose or render obvious a method 
for making the compound, which would preclude a conclusion of 
obviousness of the compound.55
    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.56 However, to be entitled to substantial 
weight, the applicant should establish a nexus between the rebuttal 
evidence and the claimed invention,57 i.e., objective 
evidence of nonobviousness must be attributable to the claimed 
invention.58 Additionally, the evidence must be reasonably 
commensurate in scope with the claimed invention.59 However, 
an exemplary showing may be sufficient to establish a reasonable 
correlation

[[Page 47004]]

between the showing and the entire scope of the claim, when viewed by a 
skilled artisan.60 On the other hand, evidence of an 
unexpected property may not be sufficient regardless of the scope of 
the showing.61 Accordingly, each case should be evaluated 
individually based on the totality of the circumstances.
    Office personnel should not evaluate rebuttal evidence for its 
``knockdown'' value against the prima facie case 62 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. Sec. 103 should rest on all the 
evidence and should not be influenced by any earlier 
conclusion.63 Thus, once the applicant has presented 
rebuttal evidence, Office personnel should reconsider any initial 
obviousness determination in view of the entire record.64 
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. Sec. 103 ground of 
rejection.65 Conclusory statements of similarity or 
motivation, without any articulated rationale or evidentiary support, 
do not constitute sufficient factual findings.

VI. Endnotes

    \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).
    \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 Sec. 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. 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 case 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. 1987)(``Before answering 
Graham's ``content'' inquiry, it must be known whether a patent or 
publication is in the prior art under 35 U.S.C. Sec. 102.'').
    \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. Sec. 103 is not whether the differences 
[between the claimed invention and the prior art] would have been 
obvious'' but ``whether the claimed invention as a whole would have 
been obvious.'' (emphasis in original).
    \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. 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

[[Page 47005]]

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). More specifically, the court in 
Petering stated:
    ``A simple calculation will show that, excluding isomerism 
within certain of the R groups, the limited class we find in Karrer 
contains only 20 compounds. However, we wish to point out that it is 
not the mere number of compounds in this limited class which is 
significant here but, rather, the total circumstances involved, 
including such factors as the limited number of variations for R, 
only two alternatives for Y and Z, no alternatives for the other 
ring positions, and a large unchanging parent structural nucleus. 
With these circumstances in mind, it is our opinion that Karrer has 
described to those with ordinary skill in this art each of the 
various permutations here involved as fully as if he had drawn each 
structural formula or had written each name.''

Id. (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. Sec. 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. 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., Dillon, 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., Dillon, 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. Dillon, 919 F.2d at 
692-93, 16 USPQ2d at 1900-02.
    Likewise, claims to amitriptyline used as an antidepressant were 
held obvious in light of the structural similarity to imipramine, a 
known antidepressant prior art compound, where both compounds were 
tricyclic dibenzo compounds and differed structurally only in the 
replacement of the unsaturated carbon atom in the center ring of 
amitriptyline with a nitrogen atom in imipramine. In re Merck & Co., 
800 F.2d 1091, 1096-97, 231 USPQ 375, 378-79 (Fed. Cir. 1986).
    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 Dillon, 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.).
    35 Dillon, 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 Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 
1904. See also In re Grabiak, 769 F.2d 729, 731, 226 USPQ 870, 871 
(Fed. Cir. 1985)(``When chemical compounds have `very close' 
structural similarities and similar utilities, without more a prima 
facie case may be made.'').
    39 Dillon, 919 F.2d at 697-98, 16 USPQ2d at 1905; In 
re Wilder, 563 F.2d 457, 461, 195 USPQ 426, 430 (CCPA 1977); In re 
Linter, 458 F.2d 1013, 1016, 173 USPQ 560, 562 (CCPA 1972).
    40 See, e.g., Dillon, 919 F.2d at 692-97, 16 USPQ2d 
at 1901-05; In re Grabiak, 769 F.2d 729, 732-33, 226 USPQ 870, 872 
(Fed. Cir. 1985).
    41 See e.g.,In re May, 574 F.2d 1082, 1094, 197 USPQ 
601, 611 (CCPA 1978)(prima facie

[[Page 47006]]

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 
USPQ2d 1593, 1606 n.42 (Fed. Cir. 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 at 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 
USPQ2d 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 invention.); Piasecki, 745 F.2d at 1472, 223 USPQ at 788 
(``[Rebuttal evidence] may relate to any of the Graham factors 
including the so-called secondary considerations.'').
    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 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, 
104 F.3d 1339, 1343-44, 41 USPQ2d 1451, 1455-56 (Fed. Cir. 
1997)(conclusory statements that claimed compound possesses 
unusually low immune response or unexpected biological activity that 
is unsupported by comparative data held insufficient to overcome 
prima facie case of obviousness).
    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 A conclusion of obviousness requires that the 
reference(s) relied upon be enabling in that it put the public in 
possession of the claimed invention. The court in In re Hoeksema, 
399 F.2d 269, 274, 158 USPQ 596, 601 (CCPA 1968), stated:
    ``Thus, upon careful reconsideration it is our view that if the 
prior art of record fails to disclose or render obvious a method for 
making a claimed compound, at the time the invention was made, it 
may not be legally concluded that the compound itself is in the 
possession of the public. [footnote omitted.] In this context, we 
say that the absence of a known or obvious process for making the 
claimed compounds overcomes a presumption that the compounds are 
obvious, based on close relationships between their structures and 
those of prior art compounds.''
    The Hoeksema court further noted that once a prima facie case of 
obviousness is made by the PTO through citation of references, the 
burden is on the applicant to produce contrary evidence establishing 
that the reference being relied on would not enable a skilled 
artisan to produce the different compounds claimed. Id. at 274-75, 
158 USPQ at 601. See also Ashland Oil, Inc. v. Delta Resins & 
Refractories, Inc., 776 F.2d 281, 295, 297, 227 USPQ 657, 666, 667 
(Fed. Cir. 1985) (citing Hoeksema for the proposition above); In re 
Grose, 592 F.2d 1161, 1168, 201 USPQ 57, 63-64 (CCPA 1979) (``One of 
the assumptions underlying a prima facie obviousness rejection based 
upon a structural relationship between compounds, such as adjacent 
homologs, is that a method disclosed for producing one would provide 
those skilled in the art with a method for producing the other. * * 
* Failure of the prior art to disclose or render obvious a method 
for making any composition of matter, whether a compound or a 
mixture of compounds like a zeolite, precludes a conclusion that the 
composition would have been obvious.'')
    56 Id. See also In re Alton, 76 F.3d 1168, 1174-75, 
37 USPQ2d 1578, 1582-83 (Fed. Cir. 1996).
    57 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).
    58 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. Sec. 103 rejection was not probative 
of nonobviousness).
    59 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

[[Page 47007]]

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).
    60. E.g., Chupp, 816 F.2d at 646, 2 USPQ2d at 1439; 
Clemens, 622 F.2d at 1036, 206 USPQ at 296.
    61. Usually, a showing of unexpected results is 
sufficient to overcome a prima facie case of obviousness. See, e.g., 
In re Albrecht, 514 F.2d 1389, 1396, 185 USPQ 585, 590 (CCPA 1975). 
However, 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.
    62. Piasecki, 745 F.2d at 1473, 223 USPQ at 788.
    63. 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).
    64. E.g., Piasecki, 745 F.2d at 1472, 223 USPQ at 
788; Eli Lilly, 902 F.2d at 945, 14 USPQ2d at 1743.
    65. 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).

    Dated: August 26, 1998.
Bruce A. Lehman,
Assistant Secretary of Commerce and Commissioner of Patents and 
Trademarks.
[FR Doc. 98-23681 Filed 9-2-98; 8:45 am]
BILLING CODE 3510-16-P