Notice2024-03967
Updated Guidance for Making a Proper Determination of Obviousness
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 27, 2024
Effective
February 27, 2024
Issuing agencies
Commerce DepartmentPatent and Trademark Office
Abstract
The United States Patent and Trademark Office (USPTO or Office) is publishing this updated guidance to provide a review of the flexible approach to determining obviousness that is required by KSR Int'l Co. v. Teleflex Inc. (KSR). The focus of this document is on post-KSR precedential cases of the United States Court of Appeals for the Federal Circuit (Federal Circuit), to provide further clarification for decision-makers on how the Supreme Court's directives should be applied. While highlighting the requirement for a flexible approach to the obviousness determination, this updated guidance also emphasizes the need for a reasoned explanation when reaching a conclusion that a claimed invention would have been obvious. This updated guidance, together with the direction provided in the Manual of Patent Examining Procedure (MPEP), serves as operable guidance for USPTO personnel when applying the law of obviousness.
Full Text
<html>
<head>
<title>Federal Register, Volume 89 Issue 39 (Tuesday, February 27, 2024)</title>
</head>
<body><pre>
[Federal Register Volume 89, Number 39 (Tuesday, February 27, 2024)]
[Notices]
[Pages 14449-14453]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-03967]
-----------------------------------------------------------------------
DEPARTMENT OF COMMERCE
Patent and Trademark Office
[Docket No. PTO-P-2023-0053]
Updated Guidance for Making a Proper Determination of Obviousness
AGENCY: United States Patent and Trademark Office, Department of
Commerce.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The United States Patent and Trademark Office (USPTO or
Office) is publishing this updated guidance to provide a review of the
flexible approach to determining obviousness that is required by KSR
Int'l Co. v. Teleflex Inc. (KSR). The focus of this document is on
post-KSR precedential cases of the United States Court of Appeals for
the Federal Circuit (Federal Circuit), to provide further clarification
for decision-makers on how the Supreme Court's directives should be
applied. While highlighting the requirement for a flexible approach to
the obviousness determination, this updated guidance also emphasizes
the need for a reasoned explanation when reaching a conclusion that a
claimed invention would have been obvious. This updated guidance,
together with the direction provided in the Manual of Patent Examining
Procedure (MPEP), serves as operable guidance for USPTO personnel when
applying the law of obviousness.
DATES: This guidance is effective on February 27, 2024.
FOR FURTHER INFORMATION CONTACT: Kathleen Kahler Fonda, Senior Legal
Advisor, Office of Patent Legal Administration, Office of the Deputy
Commissioner for Patents, at <a href="/cdn-cgi/l/email-protection#ffb49e8b97939a9a91d1b990919b9ebf8a8c8f8b90d1989089"><span class="__cf_email__" data-cfemail="c982a8bda1a5acaca7e78fa6a7ada889bcbab9bda6e7aea6bf">[email protected]</span></a> or 571-272-7754;
or Steven J. Fulk, Legal Advisor, Office of Patent Legal
Administration, Office of the Deputy Commissioner for Patents, at
<a href="/cdn-cgi/l/email-protection#91c2e5f4e7f4ffbfd7e4fdfad1e4e2e1e5febff6fee7"><span class="__cf_email__" data-cfemail="782b0c1d0e1d16563e0d1413380d0b080c17561f170e">[email protected]</span></a> or 571-270-0072.
SUPPLEMENTARY INFORMATION: More than 15 years have passed since the
Supreme Court's unanimous decision regarding the obviousness of a
claimed invention under 35 U.S.C. 103 rendered in KSR Int'l Co. v.
Teleflex Inc., 550 U.S. 398, 127 S. Ct. 1727 (2007). Since then, the
Federal Circuit has helped to refine the contours of the obviousness
inquiry. This updated guidance serves as a reminder for USPTO personnel
of the flexible approach to obviousness that is required under KSR and
Federal Circuit precedent.
This guidance does not constitute substantive rulemaking and hence
does not have the force and effect of law. It has been developed as a
matter of internal Office management and is not intended to create any
right or benefit, substantive or procedural, enforceable by any party
against the Office. Rejections will continue to be based on the
substantive law, and it is these rejections that are appealable.
Consequently, any failure by Office personnel to follow this guidance
is neither appealable nor petitionable.
The Office does not intend to announce any new Office practice or
procedure by way of this updated guidance. This guidance is based on
the Office's current understanding of the law and is believed to
comport with the binding precedent of the Supreme Court and the Federal
Circuit. Furthermore, it is meant to be consistent with the Office's
present examination policy. However, if any earlier guidance from the
Office, including any section of the current MPEP (9th Edition, Rev.
07.2022, February 2023), is inconsistent with the updated guidance set
forth in this notice, Office personnel are to
[[Page 14450]]
follow this guidance. This updated guidance will be incorporated into
the MPEP in due course.\1\
---------------------------------------------------------------------------
\1\ This notice does not address the impact, if any, of
artificial intelligence on the obviousness inquiry. The Office
continues to seek input from the public on that question and will
issue additional notices as warranted.
---------------------------------------------------------------------------
I. The America Invents Act Impacted the Time Focus of the KSR Inquiry
As a preliminary matter, it is noted that KSR was decided prior to
the March 16, 2013, effective date of the prior art provisions of the
Leahy-Smith America Invents Act, Public Law 112-29, 125 Stat. 284
(2011) (codified as amended at 35 U.S.C. 1-390 (2012)) (AIA). In
keeping with the shift from a first-to-invent statutory scheme to one
based on a first-inventor-to-file approach, Congress amended 35 U.S.C.
103 to change the time focus of the obviousness inquiry from ``at the
time the invention was made'' to ``before the effective filing date of
the claimed invention.'' \2\ When determining obviousness in a case
governed by the AIA, Office personnel should interpret references to
``at the time of invention'' in KSR (see, for example, 550 U.S. at 420,
127 S. Ct. at 1742) as if they referred to the statutory time focus
under the AIA, which is ``before the effective filing date of the
claimed invention.'' See MPEP 2158.\3\
---------------------------------------------------------------------------
\2\ Although the AIA made several other changes to Sec. 103
(for example, ``subject matter sought to be patented'' was replaced
with ``claimed invention''), none of these additional changes is
believed to impact the obviousness inquiry.
\3\ See also Adapt Pharma Operations Ltd. v. Teva Pharms. USA,
Inc., 25 F.4th 1354, 1365 (Fed. Cir. 2022) (applying KSR to claims
governed by the AIA); Dmitry Karshtedt, Nonobviousness: Before and
After, 106 Iowa L.R. 1609, 1636 n.199 (2021): ``Although the
anchoring date has since changed from the invention date to the
effective filing date, the substantive reasoning of KSR is fully
applicable to the AIA's first-to-file regime.''
---------------------------------------------------------------------------
II. The Graham Inquiries Continue To Control Obviousness Determinations
After KSR
The Supreme Court's decision in KSR clearly reaffirmed the approach
to obviousness announced in Graham v. John Deere Co., 383 U.S. 1, 86 S.
Ct. 684 (1966) (Graham). At the outset of the KSR decision, Justice
Kennedy, writing for a unanimous Court, quoted the Court's decades-
earlier obviousness decision in Graham:
Under Sec. 103, the scope and content of the prior art are to
be determined; differences between the prior art and the claims at
issue are to be ascertained; and the level of ordinary skill in the
pertinent art resolved. Against this background, the obviousness or
nonobviousness of the subject matter is determined. Such secondary
considerations as commercial success, long felt but unsolved needs,
failure of others, etc., might be utilized to give light to the
circumstances surrounding the origin of the subject matter sought to
be patented.
KSR, 550 U.S. at 406, 127 S. Ct. at 1734 (quoting Graham).
Referring to this analysis as ``objective,'' the Court then
unambiguously stated that Graham remained the law of the land: ``While
the sequence of these questions might be reordered in any particular
case, the factors continue to define the inquiry that controls.'' Id.
at 406-07, 127 S. Ct. at 1734. Since KSR, the Federal Circuit has
frequently emphasized the centrality of the Graham inquiries. See, for
example, Novartis Pharms. Corp. v. West-Ward Pharms. Int'l Ltd., 923
F.3d 1051, 1059 (Fed. Cir. 2019); Apple Inc. v. Samsung Elecs. Co., 839
F.3d 1034, 1047-48 (Fed. Cir. 2016); and Aventis Pharma S.A. v.
Hospira, Inc., 675 F.3d 1324, 1332 (Fed. Cir. 2012). Thus, USPTO
personnel continue to ground obviousness determinations in the
objective inquiries announced in Graham. See MPEP 2141, subsections I
and II.
III. The Federal Circuit's Implementation of KSR Has Reiterated a
Flexible Approach to Obviousness
A hallmark of the KSR approach to obviousness, for which the
Supreme Court found basis in Graham, is flexibility. KSR, 550 U.S. at
415, 127 S. Ct. at 1739. The KSR court mandated flexibility in at least
two respects: first with regard to the proper understanding of the
scope of the prior art, and second with regard to appropriate reasons
to modify the prior art. In its cases decided since KSR, the Federal
Circuit has reiterated these two aspects of flexibility, which are
important to a proper determination of obviousness. These aspects are
discussed in subsections III.A and III.B of this notice. Subsection
III.C concludes the discussion with the important concept, evident in
post-KSR Federal Circuit decisions, that the flexible approach does not
relieve the decision-maker of the need to provide articulated reasoning
that is grounded in fact.
A. Flexible Approach To Understanding the Scope of Prior Art
The Supreme Court's directive to employ a flexible approach to
understanding the scope of prior art is reflected in the frequently
quoted sentence, ``A person of ordinary skill is also a person of
ordinary creativity, not an automaton.'' Id. at 421, 127 S. Ct. at
1742. In this section of the KSR decision, the Supreme Court instructed
the Federal Circuit that persons having ordinary skill in the art
(PHOSITAs) also have common sense, which may be used to glean
suggestions from the prior art that go beyond the primary purpose for
which that prior art was produced. Id. at 421-22, 127 S. Ct. at 1742.
Thus, the Supreme Court taught that a proper understanding of the prior
art extends to all that the art reasonably suggests, and is not limited
to its articulated teachings regarding how to solve the particular
technological problem with which the art was primarily concerned. Id.
at 418, 127 S. Ct. at 1741 (``As our precedents make clear, however,
the analysis need not seek out precise teachings directed to the
specific subject matter of the challenged claim, for a court can take
account of the inferences and creative steps that a person of ordinary
skill in the art would employ.''). ``The obviousness analysis cannot be
confined . . . by overemphasis on the importance of published articles
and the explicit content of issued patents.'' Id. at 419, 127 S. Ct. at
1741.
Federal Circuit case law since KSR follows the mandate of the
Supreme Court to understand the prior art--including combinations of
the prior art--in a flexible manner that credits the common sense and
common knowledge of a PHOSITA. The Federal Circuit has made it clear
that a narrow or rigid reading of prior art that does not recognize
reasonable inferences that a PHOSITA would have drawn is inappropriate.
An argument that the prior art lacks a specific teaching will not be
sufficient to overcome an obviousness rejection when the allegedly
missing teaching would have been understood by a PHOSITA--by way of
common sense, common knowledge generally, or common knowledge in the
relevant art.
For example, in Randall Mfg. v. Rea, 733 F.3d 1355 (Fed. Cir.
2013), the Federal Circuit vacated a determination of nonobviousness by
the Patent Trial and Appeal Board (PTAB or Board) because it had not
properly considered a PHOSITA's perspective on the prior art. Id. at
1364. The Randall court recalled KSR's criticism of an overly rigid
approach to obviousness that has ``little recourse to the knowledge,
creativity, and common sense that an ordinarily skilled artisan would
have brought to bear when considering combinations or modifications.''
Id. at 1362, citing KSR, 550 U.S. at 415-22, 127 S. Ct. at 1727. In
reaching its decision to vacate, the Federal Circuit stated that by
ignoring evidence showing ``the knowledge and perspective of one of
ordinary skill in the art, the Board failed to account for critical
background information that could easily explain why an ordinarily
[[Page 14451]]
skilled artisan would have been motivated to combine or modify the
cited references to arrive at the claimed inventions.'' Id.
Consistent with its directive in Randall to focus on a PHOSITA's
perspective on the prior art, the Federal Circuit in Zup, LLC v. Nash
Mfg., Inc., 896 F.3d 1365 (Fed. Cir. 2018) held that there would have
been a reason to combine prior art elements known to aid in stability
for riders of water recreational devices, even without an express
teaching of simultaneous use of those elements. Id. at 1372-73. The
Federal Circuit drew attention to what a PHOSITA in the field of water
recreational devices would have known: ``Given the consistent focus on
rider stability in this industry, it would have been obvious to one of
skill in the art to have a rider use both the handles and the foot
bindings at the same time while maneuvering between riding positions.''
Id. at 1373 n.2. Thus, the Federal Circuit credited a PHOSITA with
knowledge of the industry's concern for rider stability--a matter that
could be viewed as common sense.
The Federal Circuit has made it clear that the flexible approach to
understanding prior art as mandated by the Supreme Court also extends
to the issue of whether a prior art disclosure is analogous art to the
claimed invention. To be used in an obviousness rejection, a prior art
disclosure must be analogous art to the claimed invention. In re Klein,
647 F.3d 1343, 1348 (Fed. Cir. 2004). The Federal Circuit reads KSR as
``direct[ing] us to construe the scope of analogous art broadly''
because ``familiar items may have obvious uses beyond their primary
purposes, and a person of ordinary skill often will be able to fit the
teachings of multiple patents together like pieces of a puzzle.'' Wyers
v. Master Lock Co., 616 F.3d 1231, 1238 (Fed. Cir. 2010), quoting KSR,
550 U.S. at 402, 127 S. Ct. at 1727. Consistently, in Airbus S.A.S. v.
Firepass Corp., 941 F.3d 1374 (Fed. Cir. 2019), the Federal Circuit
recalled the alternative ``same field of endeavor'' and ``reasonably
pertinent'' tests for analogous art, and stated that ``an analysis of
whether an asserted reference is analogous art should take into account
any relevant evidence in the record cited by the parties to demonstrate
the knowledge and perspective of a person of ordinary skill in the
art.'' Id. at 1379, 1383-84. More recently in Netflix, Inc. v. DivX,
LLC, 80 F.4th 1352 (Fed. Cir. 2023), the Federal Circuit noted the
flexible approach under KSR as applied to the ``same field of
endeavor'' test: ``We have affirmed findings of analogous art where the
references shared a general field of endeavor.'' Id. at 1359, citing
Unwired Planet, LLC v. Google Inc., 841 F.3d 995, 1001 (Fed. Cir.
2016); and In re Mettke, 570 F.3d 1356, 1359 (Fed. Cir. 2009).
The flexible approach to understanding the prior art is reflected
in USPTO guidance provided at MPEP 2141, subsection III: ``Prior art is
not limited just to the references being applied, but includes the
understanding of one of ordinary skill in the art.'' MPEP 2141,
subsection II.C, and MPEP 2141.03 provide guidance regarding the level
of ordinary skill in the art. Office personnel are directed to MPEP
2141.01(a) for guidance on analogous art. Consistent with KSR and
subsequent Federal Circuit case law, when evaluating the prior art from
the perspective of a PHOSITA, Office personnel must take that person's
``ordinary creativity'' into account.
B. Flexible Approach to Providing a Reason To Modify the Prior Art
Federal Circuit case law since KSR confirms that the flexible
approach to obviousness encompasses not only how to understand the
scope of prior art, but also how to provide a reasoned explanation to
support a conclusion that claims would have been obvious. Consistent
with KSR, the Federal Circuit makes it clear that the obviousness
analysis is not ``confined by a formalistic conception of the words
teaching, suggestion, and motivation.'' Intel Corp. v. Qualcomm Inc.,
21 F.4th 784, 795 (Fed. Cir. 2021), quoting KSR, 550 U.S. at 419, 127
S. Ct. at 1741. To be sure, the Federal Circuit continues to use the
word ``motivation'' in its obviousness jurisprudence. However, it is
evident that the term is no longer understood in a rigid or formalistic
way. See, for example, Norgren Inc. v. Int'l Trade Comm'n, 699 F.3d
1317, 1322 (Fed. Cir. 2012) (``A flexible teaching, suggestion, or
motivation test can be useful to prevent hindsight when determining
whether a combination of elements known in the art would have been
obvious.''); Outdry Techs. Corp. v. Geox S.p.A., 859 F.3d 1364, 1370-71
(Fed. Cir. 2017) (``Any motivation to combine references, whether
articulated in the references themselves or supported by evidence of
the knowledge of a skilled artisan, is sufficient to combine those
references to arrive at the claimed process.'')
In keeping with this flexible approach to providing a rationale for
obviousness, the Federal Circuit has echoed KSR in identifying numerous
possible sources that may, either implicitly or explicitly, provide
reasons to combine or modify the prior art to determine that a claimed
invention would have been obvious. These include ``market forces;
design incentives; the `interrelated teachings of multiple patents';
`any need or problem known in the field of endeavor at the time of
invention and addressed by the patent'; and the background knowledge,
creativity, and common sense of the person of ordinary skill.''
Plantronics, Inc. v. Aliph, Inc., 724 F.3d 1343, 1354 (Fed. Cir. 2013),
quoting KSR, 550 U.S. at 418-21, 127 S. Ct. at 1741-42. Furthermore,
the Federal Circuit has explained that a reason to optimize prior art
parameters may be found in a PHOSITA's desire to improve on the prior
art. In re Ethicon, Inc., 844 F.3d 1344, 1351 (Fed. Cir. 2017) (``The
normal desire of artisans to improve upon what is already generally
known can provide the motivation to optimize variables such as the
percentage of a known polymer for use in a known device.''). The
Federal Circuit has also clarified that a proposed reason to combine
the teachings of prior art disclosures may be proper, even when the
problem addressed by the combination might have been more
advantageously addressed in another way. PAR Pharm., Inc. v. TWI
Pharms., Inc., 773 F.3d 1186, 1197-98 (Fed. Cir. 2014) (``Our
precedent, however, does not require that the motivation be the best
option, only that it be a suitable option from which the prior art did
not teach away.'') (emphasis in original).
One aspect of the flexible approach to explaining a reason to
modify the prior art is demonstrated in the Federal Circuit's decision
in Intel Corp. v. Qualcomm Inc., 21 F.4th 784, 796 (Fed. Cir. 2021),
which confirms that a proposed reason is not insufficient simply
because it has broad applicability. Patent challenger Intel had argued
in an inter partes review before the Board that some of Qualcomm's
claims were unpatentable because a PHOSITA would have been able to
modify the prior art, with a reasonable expectation of success, for the
purpose of increasing energy efficiency. Id. at 796-97. The Board had
disagreed with Intel, in part because it viewed Intel's energy
efficiency rationale as ``no more than a generic concern that exists in
many, if not all, electronic devices'' (emphasis in original). Id. at
797. Citing KSR and reversing the Board on this point, the Federal
Circuit explained that ``[s]uch a rationale is not inherently suspect
merely because it's generic in the sense of having broad applicability
or appeal.'' Id. The Federal Circuit further pointed out its pre-KSR
holding ``that because such improvements are `technology-
[[Page 14452]]
independent,' `universal,' and `even common-sensical,' `there exists in
these situations a motivation to combine prior art references even
absent any hint of suggestion in the references themselves.' '' Id.,
quoting DyStar Textilfarben GmbH v. C.H. Patrick Co., 464 F.3d 1356,
1368 (Fed. Cir. 2006) (emphasis added by the Federal Circuit in Intel).
However, the Federal Circuit was also quick to point out that a
generally applicable rationale would not be legally sufficient if it
were asserted without explanation and in a merely conclusive way. Id.
When formulating an obviousness rejection, Office personnel may use
any clearly articulated line of reasoning that would have allowed a
PHOSITA to draw the conclusion that a claimed invention would have been
obvious in view of the facts. MPEP 2143, subsection I, and MPEP 2144.
Acknowledging that, in view of KSR, there are ``many potential
rationales that could make a modification or combination of prior art
references obvious to a skilled artisan,'' the Federal Circuit has also
pointed to MPEP 2143, which provides several examples of rationales
gleaned from KSR. Unwired Planet, 841 F.3d at 1003.
C. Flexible Approach to Obviousness Does Not Negate the Need for
Articulated Reasoning and Evidentiary Support
As discussed above, KSR's flexible approach to the obviousness
inquiry disallows ``[r]igid preventative rules that deny factfinders
recourse to common sense.'' 550 U.S. at 421, 127 S. Ct. at 1742.
Nevertheless, ``[t]he key to supporting any rejection under 35 U.S.C.
103 is the clear articulation of the reason(s) why the claimed
invention would have been obvious.'' MPEP 2142. Although this approach
is flexible, a proper obviousness rejection still requires the
decision-maker to provide adequate analysis based on evidentiary
support. This theme is a frequent one in post-KSR Federal Circuit
jurisprudence. See, for example, Perfect Web Techs., Inc. v. InfoUSA,
Inc., 587 F.3d 1324, 1330 (Fed. Cir. 2009) (``We reiterate that, on
summary judgment, to invoke `common sense' or any other basis for
extrapolating from prior art to a conclusion of obviousness, a district
court must articulate its reasoning with sufficient clarity for
review.''); Mintz v. Dietz & Watson, Inc., 679 F.3d 1372, 1377 (Fed.
Cir. 2012) (``The mere recitation of the words `common sense' without
any support adds nothing to the obviousness equation.''); Arendi
S.A.R.L. v. Apple Inc., 832 F.3d 1355, 1362 (Fed. Cir. 2016)
(``[R]eferences to `common sense'--whether to supply a motivation to
combine or a missing limitation--cannot be used as a wholesale
substitute for reasoned analysis and evidentiary support, especially
when dealing with a limitation missing from the prior art references
specified.''); In re Van Os, 844 F.3d 1359, 1361 (Fed. Cir. 2017)
(``[T]he flexibility afforded by KSR did not extinguish the
factfinder's obligation to provide reasoned analysis.''). The Federal
Circuit has itself called attention to its own repeated emphasis on
this requirement since KSR. See Van Os, 844 F.3d at 1361, quoting
Plantronics, Inc. v. Aliph, Inc., 724 F.3d 1343, 1354 (Fed. Cir. 2013)
(``Since KSR, we have repeatedly explained that obviousness findings
`grounded in ``common sense'' must contain explicit and clear reasoning
providing some rational underpinning why common sense compels a finding
of obviousness.' ''); Arendi S.A.R.L., 832 F.3d at 1362 (``[O]ur cases
repeatedly warn'' that common sense cannot substitute for reasoned
analysis and evidentiary support.).
This updated guidance reinforces the directive that Office
personnel are required to provide a clear articulation of their
reasoning, grounded in relevant facts, when making a determination that
a claim would have been obvious under 35 U.S.C. 103. As has been
discussed, precedential case law requires such an analysis.
Furthermore, ``[t]he goal of examination is to clearly articulate any
rejection early in the prosecution process so that the applicant has
the opportunity to provide evidence of patentability and otherwise
reply completely at the earliest opportunity.'' MPEP 706. Thus, clearly
articulated obviousness rejections serve the goal of compact
prosecution and allow patent practitioners and Office personnel to
conclude patent examination or other USPTO proceedings at the earliest
possible time.
IV. All Evidence Relevant to the Question of Obviousness That Is
Properly Before the Decision-Maker Must Be Considered
When reaching a determination of obviousness in view of KSR's
flexible approach as discussed above, decision-makers must consider all
relevant evidence that is properly before them. An important theme in
the law of obviousness is that the inquiry under Graham and KSR is not
limited to the first three Graham factors (i.e., scope and content of
the prior art, differences between the prior art and the claims at
issue, and the level of ordinary skill in the pertinent art). Rather,
when the so-called secondary considerations of the fourth factor (also
known as objective indicia of nonobviousness) have been made an issue
in the case, the decision-maker is not free to ignore them. In re Huai-
Hung Kao, 639 F.3d 1057, 1067 (Fed. Cir. 2011) (``[W]hen secondary
considerations are present, though they are not always dispositive, it
is error not to consider them.''); Kinetic Concepts, Inc. v. Smith &
Nephew, Inc., 688 F.3d 1342, 1360 (Fed. Cir. 2012) (``This court has
explained, moreover, that the obviousness inquiry requires examination
of all four Graham factors.'').\4\
---------------------------------------------------------------------------
\4\ For a list of additional Federal Circuit cases directing
decision-makers to consider all the Graham factors when determining
obviousness, including all evidence of obviousness or nonobviousness
that is before the decision-maker, see In re Cyclobenzaprine
Hydrochloride Extended-Release Capsule Patent Litig., 676 F.3d 1063,
1076-77 (Fed. Cir. 2012).
---------------------------------------------------------------------------
The requirement to consider all relevant evidence is part of the
establishment of a prima facie case of obviousness. In the context of
patent examination and reexamination, MPEP 2142 explains that ``[t]he
legal concept of prima facie obviousness is a procedural tool'' that
``allocates who has the burden of going forward with production of
evidence in each step of the examination process.'' At the outset of
examination, the patent examiner who issues an obviousness rejection
bears the burden of explaining how a preponderance of the evidence
supports the conclusion that the claims would have been obvious. Id. If
objective indicia of nonobviousness are properly before the examiner,
such as by way of incorporation into the written description as filed
or submission of an evidentiary declaration after the filing date, the
examiner must consider those indicia, even before the issuance of a
first Office action. A decision-maker ``must always consider any
objective evidence of nonobviousness presented in a case.'' Transocean
Offshore Deepwater Drilling, Inc. v. Maersk Contractors USA, Inc., 617
F.3d 1296, 1305 (Fed. Cir. 2010) (referring to a district court as the
decision-maker, but also applicable to USPTO decision-makers) (internal
citations omitted). ``Whether before the Board or a court, this court
has emphasized that consideration of the objective indicia is part of
the whole obviousness analysis, not just an afterthought.'' Leo Pharm.
Prod., Ltd. v. Rea, 726 F.3d 1346, 1357 (Fed. Cir. 2013) (emphasis in
original).
At each stage of USPTO proceedings, Office personnel must reweigh
all evidence that is relevant and properly of record at that time.
Newly submitted
[[Page 14453]]
evidence in rebuttal of an obviousness rejection must not be considered
merely for its knockdown value against any previously-established prima
facie case. See MPEP 2145, and in particular, the cases cited in
examples 1-3. Evidence submitted to rebut a determination of
obviousness is important because it may constitute ``independent
evidence of nonobviousness.'' Pressure Prods. Med. Supplies, Inc. v.
Greatbatch Ltd., 599 F.3d 1308, 1319 (Fed. Cir. 2010), quoting Ortho-
McNeil Pharm., Inc. v. Mylan Labs., Inc., 520 F.3d 1358, 1365 (Fed.
Cir. 2008). Such evidence ``may often be the most probative and cogent
evidence of nonobviousness in the record.'' Ortho-McNeil, 520 F.3d at
1365, quoting Catalina Lighting, Inc. v. Lamps Plus, Inc., 295 F.3d
1277, 1288 (Fed. Cir. 2002).
It follows from the directive to consider all relevant evidence
that the mere existence of a reason to modify the teachings of the
prior art may not necessarily lead to a conclusion that a claimed
invention would have been legally obvious. Intercontinental Great
Brands LLC v. Kellogg N. Am. Co., 869 F.3d 1336, 1346-47 (Fed. Cir.
2017). When stepping into the shoes of a PHOSITA, the decision-maker
should seek to understand the ``complete picture'' regarding the
PHOSITA's perspective on obviousness, having due regard for additional
evidence that may weigh against any prima facie case. Id. at 1346. In
determining whether a claimed invention would have been obvious, Office
personnel are charged with weighing all the evidence of record,
including evidence of obviousness and evidence of nonobviousness. ``If
this weighing shows obviousness by a preponderance of the evidence,
then the claims at issue were unpatentable.'' ACCO Brands Corp. v.
Fellowes, Inc., 813 F.3d 1361, 1366 (Fed. Cir. 2016).
Without diminishing the need to consider all relevant evidence when
making a determination about obviousness, the Federal Circuit has made
it clear that an expert's conclusory opinion about a matter relevant to
the obviousness inquiry may be unavailing unless accompanied by factual
support. See, for example, Ethicon, 844 F.3d at 1352 (concluding in the
context of an ex parte appeal that the Board properly gave little
weight to conclusory expert testimony regarding objective indicia);
Quanergy Sys., Inc. v. Velodyne Lidar USA, Inc., 24 F.4th 1406, 1417
(Fed. Cir. 2022) (agreeing with the Board, in the context of an inter
partes review proceeding, that the proffered expert testimony was
``incomplete, unspecific, and ultimately conclusory'' and therefore not
entitled to controlling weight). Consistently, in the context of
proceedings before the PTAB, Office regulations provide that ``[e]xpert
testimony that does not disclose the underlying facts or data on which
the opinion is based is entitled to little or no weight.'' 37 CFR
42.65(a); see also Xerox Corp. v. Bytemark, Inc., No. IPR2022-00624,
2022 WL 3648989, at *6 (PTAB 2022) (precedential) (The USPTO Director
affirmed that because ``the cited declaration testimony is conclusory
and unsupported, [it] adds little to the conclusory assertion for which
it is offered to support, and is entitled to little weight.'').
Further, during the examination of an application or the reexamination
of a patent, any objective evidence of nonobviousness must be submitted
by way of an affidavit or declaration; attorney arguments alone cannot
take the place of such evidence in the record where the evidence is
necessary. See 37 CFR 1.132; MPEP 716.01(c) and MPEP 2145, subsection
I.
Consistent with Federal Circuit precedent, Office personnel are
directed to consider all objective evidence that has been properly made
of record and is relevant to the issue of obviousness at MPEP 2141,
subsection II.
V. Office Personnel Will Continue To Apply Reasoning to Facts in Order
To Reach a Proper Legal Determination of Obviousness
Any legally proper obviousness rejection must identify facts and
then articulate sound reasoning that leads to the conclusion that the
claims would have been obvious to a PHOSITA. ``Obviousness is a
question of law based on underlying facts. . . .'' Henny Penny Corp. v.
Frymaster LLC, 938 F.3d 1324, 1331 (Fed. Cir. 2019). During patent
examination, making factual findings concerning the content of the
prior art is often the first step when considering whether or not a
claimed invention would have been obvious. As discussed above, the
obviousness determination may also involve other facts, such as those
presented in an evidentiary declaration. After making appropriate
findings of fact, Office personnel must use reasoning in accordance
with Graham and KSR to determine whether a claimed invention would have
been obvious in view of all relevant facts. Office personnel must
explain on the record how the conclusion of obviousness was reached.
See MPEP 2141, subsection II: ``Once the findings of fact are
articulated, Office personnel must provide an explanation to support an
obviousness rejection under 35 U.S.C. 103.'' See also MPEP 2142.
In keeping with the flexible approach to obviousness in KSR and
Graham, there is no one-size-fits-all approach to crafting an
obviousness rejection. See KSR, 550 U.S. at 415, 127 S. Ct. at 1739.
Different technologies or different factual situations may lend
themselves to different formats for presentation of the relevant facts,
or to different lines of reasoning to explain the legal conclusion of
obviousness. Office personnel are called on to use their legal and
technological expertise to determine how best to explain an obviousness
rejection. See Hyatt v. Kappos, 625 F.3d 1320, 1343 (Fed. Cir. 2010),
aff'd and remanded, 566 U.S. 431, 132 S. Ct. 1690 (2012). Any legally
proper obviousness rejection will be characterized by findings of fact
and a reasoned explanation showing why the claimed invention would have
been obvious to a PHOSITA. See, for example, In re Biedermann, 733 F.3d
329, 335-36 (Fed. Cir. 2013); Arctic Cat Inc. v. Bombardier
Recreational Prod. Inc., 876 F.3d 1350, 1360-61 (Fed. Cir. 2017).
Katherine K. Vidal,
Under Secretary of Commerce for Intellectual Property and Director of
the United States Patent and Trademark Office.
[FR Doc. 2024-03967 Filed 2-26-24; 8:45 am]
BILLING CODE 3510-16-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on February 27, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.