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[Federal Register Volume 89, Number 39 (Tuesday, February 27, 2024)]
[Notices]
[Pages 14449-14453]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-03967]

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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.

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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 [email protected] or 571-272-7754; 
or Steven J. Fulk, Legal Advisor, Office of Patent Legal 
Administration, Office of the Deputy Commissioner for Patents, at 
[email protected] 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\
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    \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.
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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\
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    \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.''
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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\
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    \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).
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    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]
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