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  • PTAB · Nov 21, 2025 · IPR2025-00906 · APJ Justin T Arbes · IPR · Institution

    The Board instituted IPR of claims 1–20 on all asserted grounds after finding a reasonable likelihood that claim 1 is unpatentable over 3GPP-38.213, 3GPP-38.213-CR, and 3GPP-38.212-CR.

    RulingsInstitution decision
    • Skill levelSkill level petitioner adoptedOther

      “2019),2 a person of ordinary skill in the art would have had “a bachelor’s degree in electrical engineering, computer engineering, computer science, or a similar field, along with two years of experience designing or developing wireless networks, including long-term evolution LTE/4G or 5G new radio (NR) cellular technology,” where “[a]dditional years of experience could substitute for an advanced-level degree (and vice versa).” Pet. 14 (citing Ex. 1003 ¶¶ 39–42). Patent Owner “utilizes Petitioner’s proposed level of skill in the art” for its Preliminary Response. Prelim. Resp. 7. Based on the record presented, including our review of the ’434 patent and the types of 2 Petitioner states that it “assumes for purposes of [its Petition] that the claims are entitled to the earliest claimed priority date—November 5, 2019.” Pet. 14; see Ex. 1001, code (60). problems and solutions described in the ’434 patent and cited prior art, we agree with Petitioner’s proposed definition of the level of ordinary skill in the art and apply it for purposes of this Decision.” slip op. at 10

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

      “C. Claim Interpretation We interpret each challenged claim using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. 282(b), including construing the claim in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent. 37 C.F.R. § 42.100(b). Petitioner argues that “no claim terms need be construed.” Pet. 10. Patent Owner does not propose interpretations of any claim terms in its Preliminary Response. We conclude that no express interpretation of any claim term is necessary to determine whether to institute an inter partes review in this proceeding, but encourage the parties to address various claim interpretation issues identified below during trial. See infra Section II.D.5; Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“Because we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy,’ we need not construe [a particular claim limitation] where the construction is not ‘material to the . . . dispute.’” (emphasis added) (citation omitted)).” slip op. at 11

    • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedInstituted

      “Assessing the evidence of record collectively, however, we are persuaded that Petitioner has shown a reasonable likelihood that 3GPP-38.213-CR was publicly accessible from the ETSI email archive before November 5, 2019. Given his many years of experience with ETSI, in particular his responsibilities pertaining to management of documents like change requests, and as the “list owner” “responsible for managing and administrating” several email exploder lists, Mr. Rodermund appears to be well-qualified to testify to the matters in his declaration. See Ex. 1008 ¶¶ 7, 10–15, 49. He explains in detail how, based on his experience, emails sent to a 3GPP email exploder were accessible on the email archive immediately after being sent. Id. ¶¶ 44–60, 72–80. That explanation is supported by screenshots from various websites and other corroborating evidence. See Ex. 1008 ¶¶ 44–60, 72–80. The November 3, 2019, email with 3GPP-38.213-CR as an attachment is currently available to the public via the email archive, with no login, password, or membership required to access it. Id. ¶¶ 44, 74; see Kyocera, 545 F.3d at 1351 (“[ETSI] specifications themselves were visible to any member of the interested public without requesting them from an ETSI member. Further, ETSI did not impose restrictions on ETSI members to prevent them from disseminating information about the standard to non-members.”). The metadata for the file indicates that it was created and last modified one day before the email was sent. Ex. 1008 ¶ 76. And Mr. Rodermund discusses one example where a listserv email was uploaded to the archive just minutes after being sent. Id. ¶¶ 50–51. Although that example is from 2025 rather than 2019, it provides some support for his opinion that the same “near contemporaneous” timing would have been the case in 2019 as well. See id. ¶ 52. Immediately making emails like the one with the 3GPP-38.213-CR change request available on the email archive is consistent with 3GPP’s overall purpose of making standards documents available “so that engineers and other individuals would have ready access to them when developing and implementing cellular networks and devices.” See id. ¶ 35; Kyocera, 545 F.3d at 1351 (finding that the “primary purpose of the [standard at issue] was to develop a system interoperable across national borders,” which “made it crucial to grant access to any interested parties”); Cradlepoint, Inc. v. Sisvel Int’l S.A., IPR2020-01103, Paper 46 at 13–14 (PTAB Jan. 18, 2022) (finding, based on the preponderance of the evidence, that “testimony concerning [a 3GPP] email exploder and listserv provide further support for a conclusion of public accessibility because it tends to show that 3GPP was known beyond its members, that the meetings were widely publicized, and that 3GPP documents were, in general, widely available”). Finally, Mr. Rodermund explains in detail how a person of ordinary skill in the art could have accessed the email with 3GPP-38.213-CR, using the indexing of the email archive. See Ex. 1008 ¶¶ 49, 53–60. We are persuaded that Mr. Rodermund’s testimony and supporting evidence are sufficient at this stage. Patent Owner will have the opportunity to cross-examine Mr. Rodermund and explore the bases for his statements. And our ultimate determination of the weight to be given to his testimony will be based on the complete record at the end of trial. Based on the totality of the evidence currently in the record, Petitioner has established a reasonable likelihood that 3GPP-38.213-CR is a prior art printed publication under 35 U.S.C. § 102(a)(1).” slip op. at 20

    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

      “is that Petitioner has not shown sufficiently that 3GPP-38.213-CR and 3GPP-38.212-CR are prior art printed publications. Prelim. Resp. 2–10. We disagree on this record for the reasons explained above. See supra Section II.D.4. Patent Owner does not dispute Petitioner’s arguments regarding the limitations of claim 1 or Petitioner’s asserted motivation to combine the references. See Prelim. Resp. 2–10. Petitioner’s contentions are supported by the testimony of Dr. Mandayam and are persuasive based on the current record. See Pet. 14–48; Ex. 1003 ¶¶ 52–67, 81–113. Petitioner has shown a reasonable likelihood of prevailing on its assertion that claim 1 is unpatentable over 3GPP-38.213, 3GPP-38.213-CR, and 3GPP-38.212-CR. Accordingly, we institute review “on all of the challenged claims and on all grounds of unpatentability asserted for each claim.” See 37 C.F.R. § 42.108(a).” slip op. at 28

    Claim construction§ 102 anticipationcites KSR · Graham
    Patents in suitUS 10,965,434
  • PTAB · Oct 16, 2025 · IPR2025-00712 · APJ James A Tartal · IPR · Institution

    The Board instituted inter partes review of claims 1, 3–9, 13, 17, 18, 23, 25, 26, 28, and 29 on all asserted grounds, finding a reasonable likelihood of prevailing on claim 1 over Walker.

    RulingsInstitution decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

      “review. 35 U.S.C. § 314(b) (2018); 37 C.F.R. § 42.4(a) (2025). An inter partes review may not be instituted “unless . . . the information presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon institution of inter partes review, the review proceeds “on all of the challenged claims and on all grounds of unpatentability asserted for each claim.” 37 C.F.R. § 42.108(a). Based on our consideration of the Petition, the Preliminary Response, and the evidence of record, we conclude that the information demonstrates a reasonable likelihood that Petitioner would prevail in showing the unpatentability of at least one of the Challenged Claims. Accordingly, we institute an inter partes review as to the Challenged Claims of the ’279 patent on all grounds asserted in the Petition.” slip op. at 2

    • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedOther

      “application filed November 12, 2021, that asserts the benefit of a series of applications, the earliest of which was filed September 2, 2003. Ex. 1001, codes (22), (45), (60). Petitioner asserts that the Challenged Claims of the ’279 patent “are entitled to an effective filing date of no earlier than September 2, 2003,” consistent with the date of the earliest application identified by the ’279 patent.9 See Pet. 6. For purposes of our analysis on the current record, in this Decision we apply September 2, 2003, as the priority date of the Challenged Claims.” slip op. at 18

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successInstituted

      “independent claim 1. Pet. 32–63. Petitioner relies on the testimony of Mr. Crevelt in support of its contentions with respect to claim 1. Ex. 1003 ¶¶ 234–286. Further, according to Petitioner, “[n]o findings regarding motivation to combine or reasonable expectation of success are necessary with a single reference ground,” but Walker “teaches that the features of the embodiments are options that can be combined.” Pet. 42 n.6 (citing Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1372–73 (Fed. Cir. 2019). At this stage, Patent Owner does not contest Petitioner’s proffered assertions about the” slip op. at 20

    § 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 11,393,279
  • PTAB · Oct 16, 2025 · IPR2025-00708 · APJ James A Tartal · IPR · Institution

    The Board instituted IPR on all challenged claims and grounds, finding a reasonable likelihood that claims 1, 3–5, 12, 13, 18–20, 22, 24–26, 29, 42, 44–47, and 50 are unpatentable over Walker and Schneier.

    RulingsInstitution decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

      “We have authority to determine whether to institute an inter partes review. 35 U.S.C. § 314(b) (2018); 37 C.F.R. § 42.4(a) (2025). An inter partes review may not be instituted “unless . . . the information presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon institution of inter partes review, the review proceeds “on all of the challenged claims and on all grounds of unpatentability asserted for each claim.” 37 C.F.R. § 42.108(a). Based on our consideration of the Petition, the Preliminary Response, and the evidence of record, we conclude that the information demonstrates a reasonable likelihood that Petitioner would prevail in showing the unpatentability of at least one of the Challenged Claims. Accordingly, we institute an inter partes review as to the Challenged Claims of the ’336 patent on all grounds asserted in the Petition.” slip op. at 2

    • Skill levelSkill level board ownOther

      “B. Level of Ordinary Skill in the Art At this stage of the proceeding, there is no evidentiary dispute about the level of ordinary skill in the art.8 Based on the testimony of Mr. Crevelt, we determine that a person of ordinary skill in the art would have had at least a bachelor’s degree in computer science or computer engineering, with at least three years of experience in game development. Pet. 14 (citing Ex. 1003 ¶¶ 62–65). Additional experience could substitute for less education, and additional education could likewise substitute for less experience. Id. We determine that the level of ordinary skill in the art 7 Petitioner states that it is not aware of secondary considerations that affect the obviousness arguments it presents. Pet. 66. Patent Owner has not offered objective evidence of nonobviousness at this stage of the proceeding. 8 Patent Owner “disagrees with the proposed level of skill” but asserts that “under any level of skill a [person of ordinary skill in the art] would not understand the asserted Grounds to raise any unpatentability issues.” Prelim. Resp. 8. Thus, Patent Owner does not present evidence or arguments in its Preliminary Response related to the level of ordinary skill in the art. competence reflected in the ’336 patent Specification and the asserted prior art references, based on our review of the limited record.” slip op. at 11

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

      “standard as would be used by a district court to construe a claim in a civil action involving the validity or infringement of a patent. 37 C.F.R. § 42.100(b). Under that standard, claim terms are given their ordinary and customary meaning, as would have been understood by a person of ordinary skill in the art at the time of the invention, in light of the language of the claims, the specification, and the prosecution history of record. Id.; see also Phillips v. AWH Corp., 415 F.3d 1303, 1312–19 (Fed. Cir. 2005) (en banc); Thorner v. Sony Comput. Entm’t Am. LLC, 669 F.3d 1362, 1365–66 (Fed. Cir. 2012). “The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’” Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (alteration in original) (quoting Vivid Techs., Inc. v. Am. Sci. Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Petitioner argues that it is not necessary for us to provide an express construction for any claim term because the Petition “establishes the prior art meets each claim limitation under any reasonable construction.” Pet. 14–15. Patent Owner similarly submits that we “need not construe any terms at this stage, because under any reasonable construction of the claim terms, the prior art fails to disclose or suggest the claimed features.” Prelim. Resp. 8. At this stage of the proceeding, we do not need to expressly construe any claim terms to determine whether Petitioner showed a reasonable likelihood of prevailing as to its challenge of at least one challenged claim.” slip op. at 12

    • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedOther

      “an application filed September 20, 2010, that asserts the benefit of an application filed September 2, 2003. Ex. 1001, codes (22), (45), (54), (62). Petitioner asserts that the Challenged Claims of the ’336 patent “are entitled to an effective filing date of no earlier than September 2, 2003,” consistent with the date of the earliest application identified by the ’336 patent.9 See Pet. 7. For purposes of our analysis on the current record, in this Decision we apply September 2, 2003, as the priority date of the Challenged Claims. Walker was filed on May 1, 2003, and refers back to a provisional application filed on May 6, 2002, but Walker was not published until January 1, 2004. Ex. 1006, codes (22), (43), (60). Thus, Petitioner fails to show on the current record how, under pre–AIA 35 U.S.C. § 102(a), Walker discloses an invention that was described in a printed publication in this country before the invention thereof by the Patent Owner, because Walker was published after the applied priority date of the Challenged Claims of the’336 patent.” slip op. at 17

    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 8,529,336
  • PTAB · Mar 24, 2025 · IPR2024-01235 · APJ Hubert C Lorin · IPR · Institution

    The Board instituted IPR of claims 1–3, 6–11, and 14–16 on all proposed grounds after finding a reasonable likelihood of prevailing on the §103 ground over Mañosa and Patel.

    RulingsInstitution decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

      “In an [inter partes review], the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016), 815 F.3d at 1363 (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review). slip op. at 8

    • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedPrinted publication not establishedMixed

      “[T]here is no presumption in favor of institution or in favor of finding a reference to be a printed publication under § 42.108(c) or any other authority. . . . [T]he burden is on the petitioner to identify with particularity evidence sufficient to establish a reasonable likelihood that the reference was publicly accessible before the critical date of the challenged patent, and therefore that there is a reasonable likelihood that it qualifies as a printed publication.” slip op. at 20

    • Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languageDisclaimer not foundDecided for petitioner

      “May” expresses a possibility. The Specification reflects this interpretation of “may” when it states that “[i]n one embodiment, the organic material is not lyotropic. Thus, the organic material may not be a phospholipid.” Ex. 1001, 8:27–28 (emphasis added). One of ordinary skill would understand from this that the organic material “may not be” a phospholipid if the organic material is not lyotropic. It follows that if the organic material is lyotropic, then the organic material may be a phospholipid. Reading the statement “[t]he organic material may not be . . . a phospholipid” (id. at 8:59–63) in light of the earlier stated possibility that the organic material may be a phospholipid if the organic material is lyotropic, one of ordinary skill in the art would interpret “may not be” as excluding phospholipids under some conditions, not under all conditions. Taking the Specification’s discussion about phospholipids as exemplifying the permissive nature of the word “may,” we are unpersuaded that in stating that “[t]he organic material may not be [PMMA], a polyvinylidene difluoride-containing polymer, such as [PVDF] or PVDF- TrFE-CTFE, or a phospholipid, such as [DHPE]’” (Ex. 1001, 8:59–63), the specification “contains a clear and unmistakable disavowal of the compounds PMMA, PVDF, PVDF-TrFE-CTFE, and DHPE” and “disclaims the listed compounds” from the “organic material” of the claims under all conditions, as Patent Owner argues. Prelim. Resp. 6–7. Moreover, the claims themselves limit the “organic material” only to the extent that it is “barocaloric cooling or heating agent” and can perform in the manner claimed. See Ex. 1001, claim 1, supra. As broadly worded, the claims do not exclude PMMA, PVDF, PVDF-TrFE-CTFE, and DHPE per se from the group of organic materials employed by the claimed method. Adopting Patent Owner’s construction would impermissibly import a limitation (i.e., not exclude PMMA, PVDF, PVDF-TrFE-CTFE, and DHPE) into the claims. For the reasons stated, at this stage of the proceeding, we agree with Petitioner’s broad construction of “organic material.” We do not adopt Patent Owner’s proposed construction whereby PMMA, PVDF, PVDF- TrFE-CTFE, and DHPE are excluded from the scope of the claim term “organic material.” The parties are invited to address this issue further during trial, if desired. slip op. at 11

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted

      “Petitioner shows that (a) Mañosa (i.e., inorganic compounds such as Ni-Mn-In, Gd5Si2Ge2, and La-Fe-Co-Si) and (b) Patel (i.e., PVDF-TrFE- CTFE) teach materials exhibiting inverse BCEs. Pet. 59 (citing, inter alia, Ex. 1007, pages 4–8; Ex. 1009, 1, 4–5; Ex. 1004 ¶ 108). In our view, at this stage, Petitioner sufficiently shows (via the five reasons listed supra) why it would have been obvious to one of ordinary skill in the art to substitute the barocaloric cooling or heating agent of Patel for that taught in Mañosa, thereby reaching the claimed method with a reasonable expectation of success. Cf. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (U.S., 2007) (“The Court recognized that when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.”)” slip op. at 32

    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,230,656
  • PTAB · Nov 22, 2024 · IPR2024-00687 · APJ Lisa L Tsang · IPR · Institution

    The Board instituted IPR on claims 1–4 and 7–12, finding a reasonable likelihood that claims 1–4 and 9 are anticipated by Winkler.

    RulingsInstitution decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

      “Institution of an inter partes review is authorized when “the information presented in the petition . . . and any response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a); see also 37 C.F.R. § 42.108. Upon consideration of the Petition and the Preliminary Response, we conclude that the information presented shows there is a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of at least one challenged claim of the ’017 patent.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “contends a person of ordinary skill in the art (“POSITA”) “would have had at least a bachelor’s degree in electrical engineering or a similar field and at least two years of experience working with electrical circuits or electrical connectors, including power connectors. Additional relevant work experience can compensate for less education, and vice versa.” Pet. 19 (citing Ex. 1003 ¶¶ 24–26). At this juncture, Patent Owner does not dispute the level of ordinary skill in the art. Prelim. Resp. 7. For purposes of this Decision, we adopt the level of ordinary skill in the art as articulated by Petitioner because, based on the current record, it is not disputed and is consistent with our review and understanding of the technology and descriptions in the ’017 patent and prior art of record. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). We note, however, that the open-ended language “at least” expands the range of education and experience indefinitely with no upper bound. Therefore, we do not adopt this aspect of Petitioner’s formulation.” slip op. at 9

    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner

      “At this juncture, we preliminarily agree with Patent Owner’s proffered claim construction. In particular, we agree with Patent Owner’s argument that the insulating barriers would be unable to be configured to “block[] substantially all through-air arcing paths between the first and second electrical contacts,” as claimed, unless they were electrically insulating. See Ex. 1001, 4:36–44. Moreover, as Patent Owner avers, our interpretation of “insulating” as it applies to the first and second insulating barriers should be the same as for the first and second housings. See Digital Biometrics, 149 F.3d at 1345 (“whatever interpretation we assign [to a word used in a claim] should encompass both uses because the same word appearing in the same claim should be interpreted consistently” (citation omitted)). Although “a patent’s written description can set forth more than one definition of a claim term,” we do not discern that to be the case here. See Pitney Bowes, 182 F.3d at 1310. The portions of the Specification of the ’017 patent that Patent Owner cites use “insulating” and its associated tenses to mean suppressing electrical arcing and protecting from electrical burns, i.e., electrically insulating. See, e.g., Ex. 1001, code (57), 1:58–2:3, 2:42–44, 3:2–6, 3:30–40, 3:63–4:10, cited in Prelim. Resp. 12–14. Accordingly, for purposes of this Decision, we interpret “insulating” as recited in the claims to mean “electrically insulating.”” slip op. at 11

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted

      “Petitioner’s reliance on the modified Figure 2 diagram not explicitly shown in Winkler is not per se improper, so long as the skilled artisan would have reasonably understood that that is what Winkler discloses. See Acoustic Tech., Inc. v. Itron Networked Solutions, Inc., 949 F.3d 1366, 1373 (Fed. Cir. 2020) (“In an anticipation analysis, the dispositive question is whether a skilled artisan would ‘reasonably understand or infer’ from a prior art reference that every claim limitation is disclosed in that single reference. . . . Expert testimony may shed light on what a skilled artisan would reasonably understand or infer from a prior art reference.” (citations omitted)). Dr. Eldering testifies that the diagram was “created based on FIG. 2 of Winkler and developed by taking the components of each half of the connector and recreating them in a separated state.” Ex. 1003 ¶ 80. On the current record, Patent Owner does not dispute Dr. Eldering’s testimony or that Petitioner’s diagram reflects what the skilled artisan would have reasonably understood by looking at Figure 2 of Winkler. See generally Prelim. Resp.” slip op. at 26

    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 8,808,017
  • PTAB · Oct 3, 2024 · IPR2024-00648 · APJ Devon Zastrow Newman · IPR · Institution

    The Board instituted IPR of claims 1–30 on all petitioned grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.

    RulingsInstitution decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

      “To institute an inter partes review, we must determine that the information presented in the Petition shows “a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2018). The Supreme Court has held that a decision to institute under 35 U.S.C. § 314 may not institute on less than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). After considering the information presented by the parties, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving that at least one of claims 1–30 of the ’462 patent is unpatentable.” slip op. at 2

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted

      “Design, Eligibility). At this point in the proceeding, we interpret the “in response to” limitation of claim 1 to mean that pembrolizumab is administered to a patient after the patient has been determined to be microsatellite instability high or DNA mismatch repair deficient, regardless of whether pembrolizumab is also administered to other patients. The record is devoid of evidence that one of ordinary skill in the art would have understood treating a patient “in response to” the determination that the patient has a condition to exclude the same treatment of other patients, such as the treatment of control patients not having the condition.” slip op. at 22

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted

      “5002). Dr. Neugut’s testimony supports Petitioner’s argument that the cited teachings of Brown and Duval, as well as other references, would have motivated a person of ordinary skill in the art to obtain the results of the MSI-H Study Record. See Ex. 1003 ¶¶ 124, 130, 132, 136. Petitioner argues further that Brown and Duval would have motivated one of ordinary skill in the art to obtain the results of the MSI-H Study Record by treating patients with common types of MSI-H cancers, including endometrial, small bowel, and gastric cancers. Pet. 42–43 (citing Ex. 1003, ¶ 136). Petitioner argues further that the state of the art, as demonstrated by Brown and Duval, as well as other references, would have provided one of ordinary skill in the art with a reasonable expectation of success because physicians were actively treating patients with cancers that were known to be MSI-H with PD-1 inhibitors. Pet. 43 (citing Ex. 1016; Ex. 1017; Ex. 1003 ¶¶ 131–132). According to Petitioner, these other references would have “independently urged” those of ordinary skill in the art to treat MSI-H cancer with PD-1 inhibitors or other immunotherapy, such as pembrolizumab, and would have given them a reasonable expectation of success. Pet. 44–45. Petitioner cites, along with other references, Pernot, which states “[colorectal cancers] associated with MSI could lead to a more intense immune response, but also to specific immunoregulatory phenomena, making them good candidates for immunotherapy.” (Ex. 1006,3 3741; see Pet. 43.) Petitioner also cites Champiat, which states that” slip op. at 25

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner argues that one of ordinary skill in the art relevant to the ’462 patent would have been a medical doctor or a professional in a related field with at least five years of experience with treating cancer. Pet. 11 (citing Neugut Decl., Ex. 1003 ¶ 19). Petitioner argues further that the ordinarily skilled artisan would have had experience in or access to a person with knowledge of clinical studies for therapeutics and how they work and to a pathologist with comparable experience. Id. Patent Owner, having not entered a response, does not dispute Petitioner’s proposal about the POSA’s qualifications on this record.. For this Decision, we adopt and apply Petitioner’s proposal above, which is supported by Dr. Neugut’s testimony and does not appear to be inconsistent with the level of skill reflected in the asserted prior art.” slip op. at 8

    § 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,643,462
  • PTAB · Sep 27, 2024 · IPR2024-00649 · APJ Sheridan K Snedden · IPR · Institution

    The Board instituted IPR of claims 1–28 on all six asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.

    RulingsInstitution decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

      “To institute an inter partes review, we must determine that the information presented in the Petition shows “a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2018). The Supreme Court has held that a decision to institute under 35 U.S.C. § 314 may not institute on less than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). After considering the information presented by the parties, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving that at least one of claims 1–28 of the ’187 patent are unpatentable.” slip op. at 2

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted

      “Anticipation is a question of fact, as is the question of what a prior art reference teaches. In re NTP, Inc., 654 F.3d 1279, 1297 (Fed. Cir. 2011). “Because the hallmark of anticipation is prior invention, the prior art reference—in order to anticipate under 35 U.S.C. § 102—must not only disclose all elements of the claim within the four corners of the document, but must also disclose those elements ‘arranged as in the claim.’” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008) (quoting Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983)). Whether a reference anticipates a claim is assessed from the skilled artisan’s perspective. See Dayco Prods., Inc. v. Total Containment, Inc., 329 F.3d 1358, 1368 (Fed. Cir. 2003) (“[T]he dispositive question regarding anticipation [i]s whether one skilled in the art would reasonably understand or infer from the [prior art reference’s] teaching that every claim element was disclosed in that single reference.” (quoting In re Baxter Travenol Labs., 952 F.2d 388, 390 (Fed. Cir. 1991))).” slip op. at 9

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted

      “The obviousness inquiry also typically requires an analysis of “whether there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (requiring “articulated reasoning with some rational underpinning to support the legal conclusion of obviousness”)). A petitioner cannot prove obviousness with “mere conclusory statements.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380 (Fed. Cir. 2016). Rather, a petitioner must articulate a sufficient reason why a person of ordinary skill in the art would have combined the prior art references. In re NuVasive, Inc., 842 F.3d 1376, 1382 (Fed. Cir. 2016).” slip op. at 10

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner

      “Petitioner argues that we need not construe any terms of the challenged claims to resolve the issues presented in the Petition. Pet. 11. We determine that no express construction of any claim term is necessary to determine whether to institute inter partes review. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). To the extent further discussion of the meaning any claim term is necessary to our decision, we provide that discussion below in our analysis of the asserted grounds of unpatentability.” slip op. at 8

    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,629,187
  • PTAB · Sep 27, 2024 · IPR2024-00647 · APJ Sheridan K Snedden · IPR · Institution

    The Board instituted IPR on claims 1–36 because the Petition showed a reasonable likelihood of prevailing on at least one challenged claim across the asserted grounds.

    RulingsInstitution decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

      “To institute an inter partes review, we must determine that the information presented in the Petition shows “a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2018). The Supreme Court has held that a decision to institute under 35 U.S.C. § 314 may not institute on less than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). After considering the information presented in the Petition, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving the unpatentability of at least one of claims 1–36 of the ’287 patent.” slip op. at 2

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted

      “summarized above, we are persuaded by Petitioner that the MSI-H Study Record teaches treating colorectal cancer patients after they were determined to be microsatellite instability high or DNA mismatch repair deficient with pembrolizumab. See MSI-H Study Record, Ex, 1005, 4 (Arms and Interventions); see also id., 2 (Study Identification), 3 (Study Description), 4–5 (Outcome Measures), 5–6 (Eligibility); Ex. 1003, ¶¶ 58–62. We are also persuaded that Petitioner has sufficiently shown that there is a reasonable likelihood of a causal relationship in the MSI-H Study Record between treatment of colorectal cancer patients and the determination of their MSI status — all colorectal cancer patients determined to be microsatellite instability high or DNA mismatch repair deficient were treated with pembrolizumab. Whether or not other patients were treated or enrolled in the study does not detract from this teaching.3 Accordingly, we are persuaded by Petitioner that, on this record, the MSI-H Study Record discloses each element of claim 1. In view of the above, we determine that Petitioner has sufficiently shown a reasonable likelihood of establishing that the MSI-H Study Record anticipates claim 1. Patent Owner at this stage does not offer any arguments addressing Petitioner’s substantive showing.” slip op. at 16

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted

      “not disclose the limitation of “in response to determining that the colorectal cancer is microsatellite instability high or DNA mismatch repair deficient, treating a human patient having colorectal cancer that is microsatellite instability high or DNA mismatch repair deficient with a therapeutically effective amount of pembrolizumab,” the record before us supports this limitation being rendered obvious by Pernot and the MSI-H Study Record. Specifically, because Pernot teaches that colorectal cancer patients are good candidates for immunotherapy, the evidence of the current record shows that one of ordinary skill in the art would have had a reason to use to PD-1 inhibitors to treat colorectal cancers. Ex. 1006, 3741; Ex. 1003 ¶ 136. Additionally, the focus in the MSI-H Study Record on a clinical study treating colorectal cancer patients who had been determined to be MSI-H with pembrolizumab indicates that it would have been obvious to test for this condition before treatment. The additional references discussed by Petitioner contribute further to a reasonable likelihood that Petitioner will prevail. For example, Libson reports the successful treatment of a colorectal cancer patient having MSI-H status with a PD-1 inhibitor (Ex. 1057, 463-64) and Champiat discusses evaluating the clinical activity of PD-1 agents in DNA mismatch repair, such as MSI+, colorectal cancer (Ex. 1032, e27817-5). Pet. 44 (citing Ex. 1003 ¶ 49). Thus, based on the current record, we determine that Petitioner presents a reasonable likelihood that the method of claim 1 would have been considered obvious by one of ordinary skill in the art. Accordingly, in view of the above, we are persuaded that there is a reasonable likelihood that Petitioner will prevail with respect to at least one claim challenged under Ground 2 in the Petition.” slip op. at 21

    • Skill levelSkill level petitioner adoptedOther

      “Petitioner proposes that a person of ordinary skill in the art (“POSA” or “POSITA”) at the time of the invention would be a medical doctor or a professional in a related field with at least five years of experience with treating cancer. . . . The POSA would also have experience in or access to a person with knowledge of clinical studies for therapeutics and how they work and a pathologist with comparable experience. . . . The inherent anticipation and obviousness grounds discussed herein would not change due to a modestly lesser or greater level of experience. Pet. 11–12 (citing Ex. 1003 ¶ 19). For this Decision, we adopt and apply Petitioner’s proposal above, which does not appear to be inconsistent with the level of skill reflected in the asserted prior art.” slip op. at 7

    § 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,649,287
  • PTAB · Sep 27, 2024 · IPR2024-00650 · APJ Deborah Katz · IPR · Institution

    The Board instituted IPR of claims 1–38 on all asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.

    RulingsInstitution decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

      “Director determines that the information presented in the petition filed under section 311 and any response filed under section 313 shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). We determine whether to institute an inter partes review on behalf of the Director. See 37 C.F.R. § 42.4(a).” slip op. at 2

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted

      “determined to be microsatellite instability high or DNA mismatch repair deficient were placed into a study arm and then treated with pembrolizumab. (See Ex. 1005, Ex. 1003 ¶¶ 60–73.) Because treatment of the patients was performed only after MSI-H status was determined, the MSI-H Study Record teaches treating the patients “in response to” determining their MSI- H status.” slip op. at 15

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successInstituted

      “have been expected, Petitioner cites to Brown as teaching that PD-1 inhibitors are inherently more effective when treating tumors comprised of cells that are easy for immune cells to recognize. (See Pet. 41 (citing Ex. 1034, 747).) Petitioner argues further that Duval teaches that MSI-H cancers have cells that are easy for immune cells to recognize. (See Pet. 41 (citing Ex. 1087, 5002).) Dr. Neugut’s testimony supports Petitioner’s argument that the cited teachings of Brown and Duval, as well as other references, would have motivated a person of ordinary skill in the art to obtain the results of the MSI-H Study Record. (See Ex. 1003 ¶¶ 124, 130, 132; see Pet. 41.) Petitioner argues further that Brown and Duval would have motivated one of ordinary skill in the art to obtain the results of the MSI-H Study Record by treating patients with common types of MSI-H cancers, including endometrial, small bowel, and gastric cancers. (See Pet. 41 (citing Ex. 1003 ¶ 130).) Petitioner argues further that the state of the art, as demonstrated by Brown and Duval, as well as other references, would have provided one of ordinary skill in the art with a reasonable expectation of success because physicians were successfully treating patients with cancers that were known to be MSI-H with PD-1 inhibitors. (See Pet. 42 (citing Ex. 1003 ¶¶ 131, 132).)” slip op. at 18

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner argues that one of ordinary skill in the art relevant to the ’219 patent would have been a medical doctor or a professional in a related field with at least five years of experience with treating cancer. (See Pet. 11 (citing Neugut Decl., Ex. 1003 ¶19).) Petitioner argues further that the ordinarily skilled artisan would have experience in or access to a person with knowledge of clinical studies for therapeutics and how they work and to a pathologist with comparable experience. (See id.) Dr. Neugut’s testimony supports Petitioner’s arguments regarding the level of skill that an ordinarily skilled artisan in the relevant field would have. (See Ex. 1003 ¶ 19.) Accordingly, in the analysis below, and in the absence of argument by Patent Owner to the contrary, we apply the level of skill set forth by Petitioner and refer to Dr. Neugut’s testimony of what one of ordinary skill in the art would have understood at the time the application that became the ’491 patent was filed, which does not appear to be inconsistent with the level of skill reflected in the asserted prior art.” slip op. at 8

    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,634,491
  • PTAB · Sep 23, 2024 · IPR2024-00623 · APJ Devon Zastrow Newman · IPR · Institution

    The Board instituted IPR of claims 1–7 on all asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.

    RulingsInstitution decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

      “To institute an inter partes review, we must determine that the information presented in the Petition shows “a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2018). The Supreme Court has held that a decision to institute under 35 U.S.C. § 314 may not institute on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). After considering the information presented by the parties, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving that at least one of claims 1–7 of the ’974 patent is unpatentable, and we institute inter partes review of all challenged claims on all asserted grounds. Id.” slip op. at 2

    • BurdenInstituted

      “reference—in order to anticipate under 35 U.S.C. § 102—must not only disclose all elements of the claim within the four corners of the document, but must also disclose those elements ‘arranged as in the claim.’” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008) (quoting Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983)). Whether a reference anticipates a claim is assessed from the skilled artisan’s perspective. See Dayco Prods., Inc. v. Total Containment, Inc., 329 F.3d 1358, 1368 (Fed. Cir. 2003) (“[T]he dispositive question regarding anticipation [i]s whether one skilled in the art would reasonably understand or infer from the [prior art reference’s] teaching that every claim element was disclosed in that single reference.” (quoting In re Baxter Travenol Labs., 952 F.2d 388, 390 (Fed. Cir. 1991))).” slip op. at 10

    • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

      “2. The Parties’ Contentions The parties agree that the MSI-H Study Record was publicly available by June 12, 2013. (See Pet. 7; see Prelim. Resp. 19 (“JHU submitted the MSI-H Study Record on June 10, 2013, and it was posted on clinicaltrials.gov on approximately June 12, 2013”). In its Preliminary Response, Patent Owner does not dispute Petitioner’s argument (see Pet. 8) that the MSI-H Study Record is prior art under 35 U.S.C. § 102(a) and is not covered by an exception under 35 U.S.C. § 102(b). See Prelim. Resp.” slip op. at 12

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInstituted

      “22. Our research group eventually approached Merck. Merck agreed in early 2013 to supply its then-unapproved anti-PD-1 antibody, MK-3475 (pembrolizumab) for use in the study. It was, however, the research team at Hopkins who secured IRB approval, conducted, and paid for the study. On June 12, 2013, the solicitation for patients was first posted on clinicaltrials.gov (Exhibit D). In my mind, the four arms allowed us to try to get at an answer to a question to which we did not know the answer-specifically whether or not patients with MSI-high or MMR deficient tumors would exhibit an improved response when treated with MK-3475, compared with the more common MSS [microsatellite stable] or MMR proficient colon cancers. Thus, the trial covered all patients with colon cancer, MSI and MSS, but separated into two groups. 23. The preliminary results of this study demonstrated clinical responses at an unexpectedly high rate (>50% objective response rate) in the MSI-high (MMR deficient) arm but not in the MSS (MMR proficient) arm. (Ex. 1002, 270–271.) This affidavit, submitted during prosecution of the ’974 patent, supports the argument that an improved outcome of treating a patient with a tumor exhibiting an MSI-high or a MMR deficiency status with pembrolizumab compared to similarly treating a patient without an MSI-high or a MMR deficiency status, a recited in claim 1, is an inherent result. Patent Owner does not dispute this result in the Preliminary Response. See Prelim. Resp. 7 (“The ’974 Patent reports that mismatch repair-deficient colorectal cancers (i.e., MSI-H CRC) had an immune-related objective response rate and immune-related progression-free survival rate of 40% and 78%, respectively—a huge improvement compared to the 0% and 11% rates found in mismatch repair-proficient colorectal cancers (i.e., MSI negative CRC).”).” slip op. at 17

    § 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · Graham
    Patents in suitUS 11,325,974
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