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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNDER SECRETARY OF COMMERCEFOR INTELLECTUAL PROPERTY AND
`DIRECTOR OF THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`DATE:
`
`June 9, 2022
`
`MEMORANDUM
`
`TO:
`
`FROM:__KatherineK.Vidal Votnurtnd.hliVida
`
`Membersof the Patent Trial and Appeal Board
`
`
`Under Secretary of Commerce forIntelledtudl Property and
`q
`Director of the United States Patent and Tra
`ark Office
`
`SUBJECT:|UPDATED GUIDANCE ON THE TREATMENT OF STATEMENTS
`OF THE APPLICANT IN THE CHALLENGED PATENTIN
`INTER PARTES REVIEWS UNDER§ 311
`
`
`Introduction
`
`Under 35 U.S.C. § 311(b), inter partes reviews (IPRs) maybeinstituted only “on
`
`the basis ofpriorart consisting of patents or printed publications.” Such statements are
`
`sometimesreferred to as “admissions,”
`
`33 66
`
`“applicant-admitted-prior-art,” or “AAPA.” This
`
`Memorandum sets forth the United States Patent and Trademark Office’s (USPTO)
`
`interpretation of § 311(b) and the extent to which admissions may be used in IPR
`
`proceedings. This Memorandum supersedes prior guidance, expressly the August 18,
`
`2020, “Treatment of Statements of the Applicant in the Challenged Patent in Inter Partes
`
`Reviews Under § 311” (2020 Guidance). The guidance in this Memorandum shall be
`
`followed by all members of the Patent Trial and Appeal Board (PTABorBoard),!
`
`' This Memorandum doesnot apply to requests for ex parte reexamination made pursuant
`
`Petitioner Ensign
`Exhibit 1011 - Page 1 of 7
`
`

`

`The Director issues this Memorandum underherauthority to issue binding agency
`
`guidance to govern the Board’s implementation of statutory provisions. See, e.g., 35
`
`U.S.C. 3(a)(2)(A); SOP2 at 1-2.
`
`Guidance
`
`35 U.S.C. § 311(b) provides:
`
`(b) Scope.—
`
`A petitionerin an inter partes review may requestto cancel as unpatentable
`1 or more claims of a patent only on a ground that could be raised under
`section 102 or 103 and only on the basis ofpriorart consisting of patents or
`printed publications.
`
`Section 311(b) limits the prior art that may be used as “the basis” of an IPR proceeding to
`
`“patents or printed publications.”
`
`After the issuance of the 2020 Guidance, the Federal Circuit issued its decision in
`
`Qualcomm Ince. v. Apple Inc., 24 F.4th 1367 (Fed. Cir. 2022), addressing the extentto
`which sdinisctons can be used in IPR proceedings. The court concluded, consistent with
`
`the 2020 Guidance,that under § 311, “‘patents or printed publications’ that form the
`
`‘basis’ of a groundforinter partes review must themselvesbepriorart to the challenged
`
`patent” and not the challenged patentitself or any admissions therein. Qualcomm, 24
`
`F.4th at 1374. The court clarified that, because admissions are notprior art and therefore
`
`cannot form the basis of an IPR,it is “impermissible for a petition to challenge a patent
`
`relying on solely AAPA withoutalso relying on a prior art patent or printed publication.”
`
`Id. at 1377; see, e.g., Sony Corp. v. Collabo Innovations, Inc., IPR2016-00940, Paper7,
`
`at 30 (PTAB Oct. 24, 2016) (denyinginstitution of claim 1 as anticipated by AAPA); LG
`
`Electronics, Inc. v. Core Wireless Licensing S.A.R.L., 1PR2015-01987, Paper 7, at 18
`
`Petitioner Ensign
`Exhibit 1011 - Page 2 of 7
`
`

`

`(PTAB March 24, 2016) (denying institution on ground alleging obviousnessof claims
`
`16-28 based solely on AAPA).
`
`Evidenceof the skilled artisan’s knowledge, however, remains fundamentalto a
`
`properobviousness analysis. See KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 401
`
`(2007); Randall Mfg. v. Rea, 733 F.3d 1355, 1362-63 (Fed. Cir. 2013) (“the knowledge
`
`of suchan artisan is part of the store of public knowledge that must be consulted when
`
`considering whether a claimed invention would have been obvious”); Dystar Textilfarben
`
`GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1367 (Fed. Cir. 2006).
`
`The Federal Circuit has explained that because a properly conducted § 103 inquiry
`
`“necessarily depends” on the knowledge possessed bythe ordinarily-skilled artisan, such
`
`knowledge must be considered in an IPR, notwithstanding the provisions of § 311(b):
`
`Althoughthe prior art that can be considered in inter partes reviewsis
`limited to patents and printed publications [under§ 311], it does not
`follow that we ignore the skilled artisan’s knowledge when determining
`whetherit would have been obvious to modify thepriorart. Indeed, under
`35 U.S.C. § 103, the obviousness inquiry turns not only on the priorart,
`but whether“the differences between the claimed invention and the prior
`art are such that the claimed invention as a whole would have been
`obvious .
`.
`. to a person having ordinary skill in the art to which the
`claimed invention pertains.” 35 U.S.C. § 103. Regardless ofthe tribunal,
`the inquiry into whether any “differences” between the invention and the
`prior art would have rendered the invention obviousto a skilled artisan
`necessarily depends on such artisan’s knowledge.
`
`See Koninklijke Philips v. Google, LLC, 948 F.3d 1330, 1337-39 (Fed. Cir. 2020).
`
`Admissionsare “permissible evidence in an inter partes review for establishing
`
`the background knowledge possessed by a personofordinary skill in the art” and
`
`“provide a factual foundation as to what a skilled artisan would have knownat the time of
`
`invention.” Qualcomm, 24 F4th at 1376.
`
`Petitioner Ensign
`Exhibit 1011 - Page 3 of 7
`
`

`

`Board panels should determine whetherthe petition relies on admissions in the
`specification in combination with reliance on at least one prior ait patent orprinted
`
`publication. Qualcomm, 24 F4th at 1377. If an IPR petition relies on admissions in
`
`combination with reliance on one or morepriorart patents or printed publications, those
`
`admissions do not form “the basis” of the ground and must be considered by the Board in
`
`its patentability analysis. Jd.
`
`A patentee’s admissions regarding the scope and content ofthe priorart under
`
`§ 103 can be used, for example, to: (1) supply missing claim limitations that were
`
`generally knownin theart priorto the invention (for pre-America Invents Act (AIA)
`
`patents) orthe effective filing date of the claimed invention (for post-AIA patents); (2)
`
`support a motivation to combineparticular disclosures; or (3) demonstrate the knowledge
`
`of the ordinarily-skilled artisan at the time of the invention (for pre-AIA patents) or the
`
`effective filing date of the claimed invention (for post-AIA patents) for any other purpose
`
`related to patentability. See Qualcomm, 24 F4th at 1376; see also Koninklijke Philips,
`
`948 F.3d at 1337-1338.
`
`Admissions may include statements in the specification of the challenged patent
`
`such as “Tt is well knownthat... ,” “It is well understood that... ,” or “Oneof skill in
`
`the art would readily understand that .
`
`.
`
`. ,” or may describe technology as “priorart,”
`
`“conventional,” or “well-known.” See McCoy v. Heal Sys., LLC, 850 F. App’x 785, 789
`
`(Fed. Cir. 2021) (non-precedential) (finding it was not an error for the Board in an IPR
`
`proceedingto accept the specification’s own assertions of what was “conventional” and
`
`therefore well knownin the art). Of course, parties may dispute the significance or
`
`meaning of statements in the specification or other evidence, including disputing whether
`
`Petitioner Ensign
`Exhibit 1011 - Page 4 of 7
`
`

`

`specification statements constitute admissions or evidence of the background knowledge
`
`possessed by a person ofordinaryskill in the art. For example, petitioners may rely on
`
`certain language in the specification identified supra (e.g., “It is well knownthat... ”) as
`evidence of what a skilled artisan would have known atthe time ofthe invention, and a
`
`patent ownercan chooseto dispute whetherthe petitioner has accurately characterized
`
`the evidenceit cites (e.g., offer evidence or argumentthat a statement in the specification
`
`does not reflect such knowledge oris not an admission). Either side may present expert
`testimony in support ofits position. The Board shall adjudicate such disputes and |
`
`determine whetherthe specification (or other evidencethat is not “prior art consisting of
`
`patents or printed publications”) properly constitutes evidence of the skilled artisan’s
`
`knowledgeat the time of the invention. Suchsituationsare likely to be highly fact-
`
`specific, and the Board can address them astheyarise.
`
`Because the Federal Circuit has made clearthat it is appropriate in an IPR torely
`
`on admissions in an obviousness analysis (Qualcomm, 274 F.4th 1376), Board panels
`
`should not exclude the use of admissions based on the numberofclaim limitations or
`
`claim elements the admission supplies or the order in which thepetition presents the
`
`obviousness combination(e.g., prior art modified by admission or admission modified by
`
`prior art). Rather, Board panels should review whetherthe asserted ground as a whole as
`
`applied to each challenged claim as a whole relies on admissions in the specification in
`
`combination with reliance on at least one priorart patent orprinted publication.
`
`While 37 CFR § 42.104(b)(4) states that a petition “must specify where each
`
`elementof the claim is foundin the priorart patents or printed publications relied upon,”
`
`this does not foreclose the limited use of admissions described in this Memorandum.
`
`Petitioner Ensign
`Exhibit 1011 - Page 5 of 7
`
`

`

`Section 42.104(b) specifies what petitions must contain and requires specific information
`
`from the parties to ensure orderly proceedings, but does not narrow the scope of IPR
`
`petitions further than § 311 itself does. For example, § 42.104(b)(3) requiresthat
`
`petitioners include their construction of claim terms. Nevertheless, the Board does not
`
`denypetitions under § 42.104 in which petitioners assert that terms should be given their
`
`ordinary meaning. Similarly, the Board should not denya petition in which an applicant
`
`points to general knowledge and/ora patentee’s admissions regarding the scope and
`
`contentofthe priorart to satisfy a claim limitation. See American Farm Lines v. Black
`
`Ball Freight Serv., 397 U.S. 532, 539 (1970)(“it is always within the discretion of a court
`
`or an administrative agency to relax or modify its procedural rules adopted forthe orderly
`
`transaction of business beforeit”); see also 37 CFR § 42.5(b)(stating that “[t]he Board
`
`may waive or suspend a requirement ofparts 1, 41, and 42”),
`
`In addition to the use of admissions as described above, other AIA provisions
`
`support using evidence outside of prior art patents or printed publications when assessing
`
`§§ 102 or 103 issues in an IPR. Qualcomm, 24 FAth at 1375-1376. For example, 35
`
`U.S.C. § 312(a)(3)(B) states that an IPR petition can include “affidavits or declarations of
`
`supporting evidence and opinions.” Section 314(a) indicates that the decision whetherto
`
`institute the requested IPR should consider such supporting evidence. See 35 U.S.C. §
`
`314(a) (the Director may institute if “the information presented in the petition” meets the
`
`applicable standard) (emphasis added). Similarly, § 316(a)(3) permits the USPTO to
`
`promulgate regulations to permit the submission of “supplemental information” by the
`
`* While § 42.104 doesnotnarrow the scope of permissible petitions under § 311, neither
`does it broadenit. The basis of every petition must be one or morepriorart patents or
`
`Petitioner Ensign
`Exhibit 1011 - Page 6 of 7
`
`

`

`petitioner. See 37 CFR § 42.123 (providing forthe filing of supplemental information).
`
`Consistent with § 311, these provisions allow for an important, but limited, role for
`
`evidence other than priorart patents and printed publications in IPRs. Qualcomm, 24
`
`F.4th at 1375-1376.
`
`Petitioner Ensign
`Exhibit 1011 - Page 7 of 7
`
`

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