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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 baird-comments@uspto.gov.
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