• Fujirebio Diagnostics, Inc. v. Quanterix Corp.Institution denied
  PTAB · Oct 17, 2025 · IPR2025-01060 · APJ Coke Morgan Stewart · IPR · Director review

  The Director granted Quanterix’s request for discretionary denial and denied institution of IPR based on the examiner’s consideration of copying evidence and the holistic assessment.

  RulingsDirector review decision

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied

    “is appropriate because the patent examiner found that the objective indicia of nonobviousness evidence was persuasive in allowing the patent application. DD Req. 13–30. Although Petitioner addresses the sufficiency of Patent Owner’s evidence, Petitioner has not persuasively demonstrated that the Office erred in evaluating this evidence. DD Opp. 21; Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential). Rather, Petitioner merely disagrees with the Examiner’s treatment of the evidence without showing material error. DD Opp. 21–26. “If reasonable minds can disagree regarding the purported treatment of the art or arguments, it cannot be said that the Office erred in a manner material to patentability.” See Advanced Bionics, Paper 6 at 9. Under these circumstances, discretionary denial is appropriate.” slip op. at 2

  • Other 314aInstitution denied discretionary otherInstitution denied

    “Furthermore, to the extent resolution of this issue may require additional evidence regarding objective indicia of nonobviousness, a district court may be the more appropriate venue, as it may allow for more robust discovery. Accordingly, the considerations that favor discretionary denial outweigh those that counsel against it. Although certain arguments are highlighted above, the determination to exercise discretion to deny institution is based on a holistic assessment of all of the evidence and arguments presented. Accordingly, the Petition is denied under 35 U.S.C. § 314(a).” slip op. at 3

  • Obviousness (§103) › Objective indicia / secondary considerations › CopyingObjective indicia with nexusDecided for patent owner

    “particular, in allowing the challenged patent, the patent examiner stated that Patent Owner provided rebuttal evidence of copying by others sufficient to overcome the obviousness rejection. Ex. 1002, 659–660. The patent examiner explained that “no group prior to the effective filing date had done more than perhaps suggest” using the claimed assay, “while dozens of groups utilized” that assay “after the date of Applicant’s contribution.” Id. at 660. Patent Owner argues that discretionary denial under 35 U.S.C. 325(d) is appropriate because the patent examiner found that the objective indicia of nonobviousness evidence was persuasive in allowing the patent application. DD Req. 13–30. Although Petitioner addresses the sufficiency of Patent Owner’s evidence, Petitioner has not persuasively demonstrated that the Office erred in evaluating this evidence. DD Opp. 21; Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential). Rather, Petitioner merely disagrees with the Examiner’s treatment of the evidence without showing material error. DD Opp. 21–26. “If reasonable minds can disagree regarding the purported treatment of the art or arguments, it cannot be said that the Office erred in a manner material to patentability.” See Advanced Bionics, Paper 6 at 9. Under these circumstances, discretionary denial is appropriate.” slip op. at 2

  § 103 obviousnessDiscretionary denial
  Patents in suitUS 11,275,092
• Skechers U.S.A., Inc. v. Nike, Inc.Institution denied
  PTAB · Jun 10, 2025 · IPR2025-00141 · APJ Ken B Barrett · IPR · Institution

  The Board denied institution on all challenged claims under §325(d), finding the petition relied on previously presented art and did not show material error by the Office.

  RulingsInstitution decision

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied

    “The Board uses a two-part framework in determining whether to exercise its discretion under § 325(d), specifically: (1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of [the] first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, Paper 6 at 8.” slip op. at 11

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

    “single §102 rejection based solely on Nishida.” Pet. § 325(d) Reply 3 (emphasis omitted). Specifically, Petitioner argues that: The examiner seemingly failed to consider how it would have been obvious to combine Nishida (or any other reference of record, such as Orei) with knowledge in the art, including the fact that it was “well known to use double needle-bar raschel machines . . . to knit textile elements simultaneously with surrounding textile structures” (Pet., 37–38), and that simultaneous knitting would be obvious because it would “increase yield and reduce manufacturing steps,” as explained in the Petition and supporting evidence. See Pet., 42–44. Id. (alterations in original); see also id. at 4 (Petitioner arguing that the Examiner clearly erred for “failing to seemingly even consider if it would 10 We quote here, to give context to “otherwise,” both aspects that a petitioner must demonstrate in order to meet its burden. In order to determine whether Petitioner has met its overall burden, we need not and do not reach the issue of whether “the previously presented art [Nishida] teaches the limitations of the challenged claims.” Ecto World, Paper 13 at 6. have been obvious to combine Nishida with other prior art, or to implement Nishida using well-known techniques for simultaneously knitting textile elements and surrounding structures having differing textures.”). We do not find this argument persuasive. The cited portion of the Petition is the contention that Orei—not Nishida—would render obvious claim 1. See Pet. 37–38, 42–44 (Ground 1A). Thus, Petitioner has not shown persuasively that the Examiner erred in not making an obviousness rejection based on Nishida because the disputed limitation was purportedly well-known. Additionally, Petitioner’s support for the assertion that this limitation is well-known is not persuasive. The Petition parenthetically quotes from a source stating that plural “articles . . . can be simultaneously knitted side-by-side,” not that an article (a textile element) and surrounding textile structure are known to be simultaneously knitted. See Pet. 38 (quoting Ex. 1050, 201) (emphasis added); see also Pet. § 325(d) Reply 3 (Petitioner quoting its own argument and characterizing it as a “fact” (“The examiner seemingly failed to consider . . . the fact that it was ‘well known . . . “)).” slip op. at 21

  § 103 obviousnessDiscretionary denial
  Patents in suitUS 8,266,749
• Intel Corporation v. Interdigital, Inc.Institution denied
  PTAB · Apr 1, 2025 · IPR2024-01441 · APJ Lisa A Murray · IPR · Institution

  The Board denied institution on all four grounds for claims 1–8 under § 325(d), finding the art or arguments previously presented and no material Examiner error shown.

  RulingsInstitution decision

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied

    “Director may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.” 35 U.S.C. § 325(d). The Board uses a two-part framework for evaluating arguments under Section 325(d): (1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of the first part of the framework is satisfied, whether the petitioner has demonstrated that the” slip op. at 9

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

    “CLAIM CONSTRUCTION Both Petitioner and Patent Owner argue that the Board can determine whether to grant or deny institution without construing any claim terms. Pet. 16; Prelim. Resp. 17. They represent, however, that the construction of the term “sparse de-noising filter” is contested in the co-pending investigation under 19 U.S.C. § 1337 at the U.S. International Trade Commission (“ITC”). Pet. 13; see Prelim. Resp. 6–8. In that litigation, four constructions were proposed for that term: ITC Complainants’ proposal, ITC” slip op. at 6

  Claim constructionDiscretionary denial
  Patents in suitUS 9,674,556
• Nexus Pharmaceuticals, LLC v. Exela Pharma Sciences, LLCInstitution denied
  PTAB · Aug 8, 2024 · PGR2024-00016 · APJ Ulrike W Jenks · PGR · Institution

  The Board denied institution of PGR on claims 1–30 under § 325(d), finding substantially the same art or arguments had been presented to the Office and no material error was shown.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied 325dInstitution denied

    “Under 35 U.S.C. § 324(a), a post-grant review may be instituted only if “the information presented in the petition . . . demonstrate[s] that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” Post-grant review is available for patents that issue from applications that at one point contained at least one claim with an effective filing date on or after March 16, 2013. See Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284 (2011) (“AIA”), §§ 3(n)(1), 6(f)(2)(A). After considering the briefing and the evidence of record, for the reasons set forth below, we exercise discretion to deny institution under § 325(d). Accordingly, we do not institute a post-grant review of the challenged claims of the ’370 patent.” slip op. at 2

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied

    “review, “the Director may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.”3 Our § 325(d) analysis employs a two-prong framework: (1) whether the arguments presented in the petition are the same or substantially the same as those previously presented to the Office; and (2) if so, whether the petitioner has demonstrated a material error by the Office in its prior consideration of those arguments. Advanced Bionics, LLC v. Med-El Electromedizinishe Gerӓte GmbH, IPR2019-01469, Paper 6 (“Advanced Bionics”), 8 (PTAB Feb. 13, 2020) (precedential). We consider several non-exclusive factors as set forth in Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8 (Dec. 15, 2017) (precedential as to § III.C.5, first paragraph) (“Becton, Dickinson”), which “provide useful insight into how to apply the 3 The Board institutes trial on behalf of the Director. 37 C.F.R. § 42.4(a). framework” under § 325(d). Advanced Bionics, 9. These non-exclusive factors include: (a) the similarities and material differences between the asserted art and the prior art involved during examination; (b) the cumulative nature of the asserted art and the prior art evaluated during examination; (c) the extent to which the asserted art was evaluated during examination, including whether the prior art was the basis for rejection; (d) the extent of the overlap between the arguments made during examination and the manner in which Petitioner relies on the prior art or Patent Owner distinguishes the prior art; (e) whether Petitioner has pointed out sufficiently how the Examiner erred in its evaluation of the asserted prior art; and (f) the extent to which additional evidence and facts presented in the Petition warrant reconsideration of the prior art or arguments. Becton, Dickinson, 17–18 (formatting added). “If, after review of factors (a), (b), and (d), it is determined that the same or substantially the same art or arguments previously were presented to the Office, then factors (c), (e), and (f) relate to whether the petitioner has demonstrated a material error by the Office.” Advanced Bionics, 10.” slip op. at 10

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner contends that a person of ordinary skill in the art: would have had an advanced degree like a Ph.D. or equivalent in chemistry, biochemistry, pharmaceutics, pharmacy, or a related pharmaceutical field, with at least two years of experience in pharmaceutical formulation development, analysis, optimization and manufacturing, including experiences with processes and techniques for minimizing impurities in, and improving the stability of, pharmaceutical drug products during manufacture and storage. Pet. 27 (citing Ex. 1003 ¶ 24). Petitioner also states that one of ordinary skill in the art “may also have lesser levels of education but more years of experience” and “[a] multi-disciplinary team consisting of individuals with different skills and experience could also suffice.” Id. Patent Owner argues that: A person of ordinary skill in the art has attained a Pharm. D., or M.S. or Ph.D. in chemistry, chemical engineering, or a related field; has three or more years of experience in developing aqueous drug formulations; and has access to other scientists to collaborate and consult with on, for example, characterizing the drug formulation, manufacture of the drug formulation, and clinical use and effect of the drug formulation.” slip op. at 7

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

    “Because this Decision declining to institute trial does not necessitate the application of any express claim construction, we need not construe any terms. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 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))).” slip op. at 8

  Claim constructionDiscretionary denial
  Patents in suitUS 11,642,370
• Advance Medical Designs, Inc. v. Corbin Clinical Resources, LLCInstitution denied
  PTAB · Jan 23, 2024 · PGR2023-00041 · APJ Jamie T Wisz · PGR · Institution

  The Board denied institution of PGR on claims 1, 4–6, 11–13, 16–18, 23, 24, 28, and 29 under § 325(d), finding substantially the same art was previously presented and no material Office error was shown.

  RulingsInstitution decision

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied

    “Section 325(d), the Board uses the following two-part framework: (1) determining whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of the first part of the framework is satisfied, determining whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, Paper 6 at 8.” slip op. at 20

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner

    “are defined by the claims themselves. For example, claim 1 recites “coupling the access needle to one of the plurality of needle receiving ports of the displacement member of the transperineal biopsy guide such that a position and angle of the access needle relative to the displacement member is retained.” Ex. 1001, 36:1–5 (emphasis added). Similarly, claim 13 recites “securing the access needle to the displacement member such that a position and angle of the access needle relative to the displacement member is maintained.” Id. at 36:59–61 (emphasis added).” slip op. at 13

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “Further, although Petitioner contends that BK Medical’s needle guide “maintains and stabilizes” the needle position, they provide no explanation as to how it does so and do not appear to account for forces that would move the position of the needle during insertion. Petitioner cites to testimony from their declarant, Dr. Yun, to provide support for this argument; however, Dr. Yun’s testimony is essentially a verbatim repetition of Petitioner’s argument without a discussion of how BK Medical’s needle guide provides such stability. Compare Pet. 59–60 with Ex. 1003 ¶ 107. Thus, we accord little weight to Dr. Yun’s testimony on this topic. 37 C.F.R. § 42.65(a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”); see also Xerox Corp. et al., v. Bytemark, IPR2022-00624, Paper No. 9 at 15 (PTAB Aug. 24, 2022) (precedential) (“Conclusory expert testimony “is particularly problematic in cases where, like here, expert testimony is offered not simply to provide a motivation to combine prior-art teachings, but rather to supply a limitation missing from the prior art.”).” slip op. at 31

  • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Not reached

    “V. 35 U.S.C. § 324(a) Patent Owner also contends that the Board should discretionarily deny institution of the post-grant review under 35 U.S.C. § 314(a) in view of the co-pending Maryland District Court litigation, pursuant to Fintiv. Prelim. Resp. 21–32; see Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 (PTAB 20 Although we do not specifically discuss the “securing” limitation of claims 13 and 24, the same analysis would apply. 21 We also do not find the testimony of Dr. Záťura or Ex. 1009 to be relevant to the question of whether the Examiner materially erred in finding that the prior art does not teach the “coupling” limitation. Mar. 20, 2020) (precedential). Because we deny the petition under 35 U.S.C. § 325(d), this argument is moot. Further, we note that Petitioner has filed a stipulation under Sotera Wireless, Inc. v. Masimo Corp., IPR2020-01019, Paper 12 at 19 (PTAB Dec. 1, 2020) (precedential as to § II.A). Pet. 112. Our analysis under Fintiv is guided by the USPTO Director’s Memorandum issued on June 21, 2022, titled “Interim Procedure for Discretionary Denials in AIA Post Grant Proceedings with Parallel District Court Litigation” (“Director’s Memorandum”).22 Pursuant to the Director’s Memorandum, we “will not discretionarily deny institution of an IPR or PGR in view of parallel district court litigation where a petitioner stipulates not to pursue in a parallel district court proceeding the same grounds as in the petition or any grounds that could have reasonably been raised in the petition.” Director’s Memorandum, 7.” slip op. at 38

  Claim constructionDiscretionary denial
  Patents in suitUS 11,547,436
• Hugel, Inc. v. Medytox Inc.Institution denied
  PTAB · Aug 28, 2023 · IPR2023-00604 · APJ Jo-Anne M Kokoski · IPR · Institution

  The Board denied institution: Ground 1 did not show claims 1–9 likely obvious over Jung and Ton; it denied Ground 2 under § 325(d).

  RulingsInstitution decision

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

    “Petitioner “has the burden from the outset 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); see also SAS Inst., Inc. v. Iancu, 138 S.Ct. 1348, 1355 (2018) (“in an inter partes review, the petitioner is the master of its complaint”). A petition for inter partes review must identify how the challenged claims are unpatentable, and must specify where each element of the claim is found in the relied-upon prior art. 37 C.F.R. § 42.104(b); see also 35 U.S.C. § 312(a)(3) (a petition must identify, “with particularity, each claim challenged, the grounds on which the challenge to each claim is based, and the evidence that supports the grounds for the challenge to each claim”). A petition must also include “a detailed explanation of the significance of the evidence including material facts, and the governing laws, rules, and precedent.” 37 C.F.R. § 42.22(a)(2). What is missing from both the Petition and the supporting testimony is an adequate explanation of how or why a POSA would have understood that Jung teaches the isolation of a botulinum toxin type A macro complex in particular, when Jung is silent as to the form of the toxin being produced. In this case, it is not enough to simply cite evidence; an explanation of the significance of that evidence is necessary. Based on our review of the record, we find that there is insufficient explanation and insufficient supporting evidence that Jung teaches isolating a botulinum toxin type A macro complex. Petitioner’s statements, and Dr. Bates’s testimony, that Jung teaches isolating a botulinum toxin, and that botulinum toxins “naturally comprise[] a complex with a variety of non-toxic proteins bound thereto” that can be intermediate, large, or macro in size, are conclusory because they do not explain why the form of toxin ultimately isolated in Jung is a macro complex. Therefore, Petitioner does not sufficiently show that the combination of Jung and Ton discloses “[a] method of isolating a botulinum toxin type A macro complex from a botulinum containing solution” or “separating the botulinum toxin type A macro complex from the cation exchange chromatography medium” as required by claim 1 of the ’598 patent.” slip op. at 13

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied

    “the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.” The Board uses a two-part framework for evaluating arguments under § 325(d): (1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential) (“Advanced Bionics”). In applying this framework, we consider the Becton, Dickinson10 factors that address discretion to deny institution when a petition presents the same or substantially the same prior art or arguments previously presented to the Office, including:” slip op. at 17

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable

    “To support a conclusion of obviousness when combining the teachings of multiple references, an articulated reason with some rational underpinning to combine the known elements in the fashion claimed must be provided. See KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 418 (2007); see also In re Magnum Oil Tools, Int’l, Ltd., 829 F.3d 1364, 1381 (Fed. Cir. 2016) (It is the petitioner’s “burden to demonstrate both that a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention[s], and that the skilled artisan would have had a reasonable expectation of success in doing so.” (citation and internal quotation marks omitted)). Here, the Petition lacks an adequate explanation as to why a POSA reading Kim ’741 would have looked to Jung for its teachings regarding anion exchange chromatography, and how a POSA would have combined the teachings of Kim ’741 and Jung in the manner claimed. Because we are not persuaded that Petitioner sufficiently establishes a motivation to combine Kim ’741 and Jung with respect to the anion exchange chromatography limitation of claim 1, we are not persuaded that Petitioner’s alternative assertion of Jung for this limitation warrants reconsideration of the prior art and arguments previously considered by the Office. Accordingly, we find that the Examiner’s failure to consider Jung in combination with Kim ’741 with respect to the anion exchange chromatography limitation of claim 1 is not an error that weighs in favor of institution.” slip op. at 29

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “the graduate degree.” Pet. 17 (citing Ex. 1021 ¶ 22). Patent Owner states that, for purposes of its Preliminary Response, it does not challenge Petitioner’s proposed definition of a POSA. Prelim. Resp. 20. For purposes of this Decision, and based on the current record, we adopt the uncontested assessment offered by Petitioner.” slip op. at 6

  Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR
  Patents in suitUS 11,331,598
• LG Electronics Inc. / LG Electronics USA, Inc. v. Image Processing Technologies, LLCInstitution denied
  PTAB · May 11, 2023 · IPR2023-00104 · APJ Barbara A Benoit · IPR · Institution

  The Board denied institution on claim 1, finding the petition presented the same or substantially the same art or arguments previously considered by the Office.

  RulingsInstitution decision

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied

    “under 35 U.S.C. § 325(d) to deny institution of an inter partes review. See 37 C.F.R. § 42.4(a) (The Director delegated her authority to determine whether trial should be instituted to the Board.). Section 325(d) of Title 35 of the United States Code states, in relevant part: “In determining whether to institute or order a proceeding under this chapter, chapter 30, or chapter 31, the Director may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.” We use a two-part framework for evaluating arguments under § 325(d): (1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims.” slip op. at 12

  • Prior constructionPrior construction adoptedDecided for petitioner

    “applied the construction of “the [at least two] calculation units being configured to form a histogram representative of the parameter” (the “common parameter” limitation) as meaning “the histogram calculation units being configured to each form a histogram representative of at least one common parameter.” Ex. 1005 (IPR 336 Final Written Decision), 12– 14; see Ex. 1006 (IPR 1189 Decision Denying Institution), 9; Ex. 1007 (Reexam 056 Decision finding claim 1 patentable), 8.” slip op. at 11

  Claim constructionDiscretionary denialcites Phillips · Graham
  Patents in suitUS 6,959,293
• Google LLC v. Valtrus Innovations LimitedInstitution denied
  PTAB · Jan 3, 2023 · IPR2022-01197 · APJ Sheldon M Mcgee · IPR · Institution

  The Board denied institution because Petitioner did not show a reasonable likelihood of prevailing on the Ogawa grounds and § 325(d) barred the Vea grounds.

  RulingsInstitution decision

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

    “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) (2018). The findings and conclusions set forth in this Decision are provided for the exclusive purpose of explaining our determination that Petitioner has not met that standard on this record. slip op. at 7

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied

    “framework set forth under Advanced Bionics, LLC v. Med-El Electromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 7 (PTAB Feb. 13, 2020) (precedential) (“Advanced Bionics”). Under that framework, we must first determine whether the same or substantially the same art or arguments previously were presented to the Office. If so, we must then determine whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of the challenged claims. Id. at 8.” slip op. at 21

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “On this record, we determine that the level of ordinary skill is reflected in the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (specific findings on the ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163–64 (Fed. Cir. 1985))). A more specific definition is not necessary for purposes of deciding whether to institute review. To the extent a more specific definition is required, however, we adopt Petitioner’s proposed definition because, on this record, it is consistent with the disclosures of the asserted prior art references.” slip op. at 10

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “12 Dr. Madisetti’s testimony here is entitled to little to no weight as it merely parrots the Petition. 37 C.F.R. § 42.65(a).” slip op. at 19

  § 103 obviousnessDiscretionary denialcites Phillips
  Patents in suitUS 6,816,809
• Miltenyi Biomedicine GmbH / Miltenyi Biotec Inc. v. The Trustees Of The University Of PennsylvaniaInstitution denied
  PTAB · Oct 11, 2022 · IPR2022-00853 · APJ Robert A Pollock · IPR · Institution

  The Board denied institution on all challenged claims under § 325(d), finding substantially the same art had been presented to the Office and no material examination error was shown.

  RulingsInstitution decision

  • Skill levelSkill level board ownOther

    “In addressing the level of ordinary skill in the art, Petitioner contends that: A POSA is a person skilled in the art of administering CAR T-cell therapies. The person would possess a relatively high level of skill and have at least an MD, together with several years of experience in administering CAR T-cell therapies. The person would also have experience designing CARs. The POSA would have knowledge of the scientific literature pertaining to immunology, including CARs and methods for utilizing CARs before the priority date. A POSA would also be knowledgeable about laboratory techniques related to engineering and testing the function of CAR T-cells. A POSA would also be knowledgeable about designing clinical trials, including selecting dose ranges, that evaluate CAR T-cell therapies. Pet. 10. Patent Owner does not presently contest this definition. Although Petitioner’s definition generally comports with our understanding of the high level of skill in the art, we are not persuaded all of the asserted qualifications must be embodied in a single person. For example, it seems unduly limiting to require that the person of ordinary skill in the art have “at least an MD” degree, and “be knowledgeable about laboratory techniques related to engineering and testing the function of CAR T-cells,” as Petitioner suggests. Accordingly, we provisionally adopt Petitioner’s definition with the caveat that the asserted qualifications may be shared among multiple individuals working as part of a multidisciplinary team. C. Claim Construction” slip op. at 14

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notNot reached

    “Patent Owner points out that the structure of independent claim 1 here is similar to those addressed in Eli Lilly. Prelim. Resp. 18. And, as in Eli Lilly, the Specification of the ’140 patent underscores the centrality of the method recited in the preamble. Id. (citing Ex. 1001, codes (54), (57), 1:55– 57). Unlike in Eli Lilly, however, the body of independent claim 1 does not recite merely “an effective amount” but “an anti-tumor effective amount” of the composition administered. Petitioner argues that whereas the preambles in Eli Lilly “provide the only metric by which one practicing the claim could determine whether the amount administered is an ‘effective amount,’” the term “anti-tumor effective amount” in independent claim 1 “is well-defined by the specification and provides sufficient guidance for determining effectiveness.” Prelim. Reply 3 (citing Eli Lilly at 1342). On balance, Petitioner appears to have the better argument. Nonetheless, even if we were to construe the treatment language of the preamble to mean “reducing the frequency or severity of at least one sign or symptom of cancer” as Patent Owner proposes, this definition is coextensive with, if not subsumed by, the term “anti-tumor effective amount,” discussed below. As such, the outcome of this proceeding does not turn on whether the preamble is limiting.” slip op. at 17

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

    “As we understand it response, Patent Owner does not appear to contest that “anti-tumor effect” can comprise a decrease in the number of tumor cells, but argues that the claim term requires “a palpable therapeutic effect,” which is more than “just the death of a single cancer cell or handful of cells.” Prelim. Resp. 19–23; Prelim. Sur-reply 4–5. In support, Patent Owner points to the ’140 patent’s express definition of “[a]n ‘effective amount’” as meaning “an amount which provides a therapeutic or prophylactic benefit.” Pet. 20 (citing Ex. 1001, 13:53–54). Relatedly, we note that the Specification also teaches that a “‘therapeutically effective amount’ includes that amount of a compound that, when administered, is sufficient to prevent development of, or alleviate to some extent, one or more of the signs or symptoms of the disorder or disease being treated.” Ex. 1001, 18:12–15. Patent Owner further contends that “[t]he specification teaches that ‘an antitumor effective amount’ is an amount to be administered that is “determined by a physician” as part of determining ‘[t]he optimal dosage and treatment regime for a particular patient . . . by monitoring the patient for signs of disease and adjusting the treatment accordingly.’” Prelim. Resp. 22 (citing Ex. 1001, 37:53–38:5). Considering the argument and evidence of record, we agree with Patent Owner that one of ordinary skill in the art would understand an “anti- tumor effective amount” as used in claim 1 to require more than the killing of a single tumor cell. Accordingly, we provisionally construe “anti-tumor effective amount” as any amount of CAR T-cells administered to a patient in need of cancer treatment that reduces the frequency or severity of at least one clinically relevant sign or symptom of the disease. To the extent this functional limitation is satisfied, claim 2 indicates that an “anti-tumor effective amount” may be limited to between 104 to 109 CAR T-cells/kg body weight. At this stage of the proceeding, no other term requires construction.” slip op. at 19

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

    “reasonable expectation of success in light of the unpredictability of cancer therapy and the “uninspiring” results and failures of earlier CAR-T clinical trials. Prelim. Resp. 23–28 (citing e.g., Ex. 2037, 1036; Ex. 2010, 1824– 1825; Ex. 2032, 1250–1251). In support, Patent Owner points to OSI Pharms. as “directly on-point.” Id. at 24 (citing OSI Pharms., LLC v. Apotex Inc., 939 F.3d 1375 (Fed. Cir. 2019)). The claims at issue in OSI Pharms., were structurally similar to those at issue here and directed to a method of treating non-small cell lung cancer (“NSCLC”) in a mammal using a therapeutically effective amount of erlotinib, which had previously been shown to inhibit the epidermal growth factor receptor (“EGFR”) in vitro. 939 F.3d at 1378–79. The court stated: Cancer treatment is highly unpredictable. Even though the EGFR was identified in some cancers as a drug target, the in vitro (i.e., in a test tube) effectiveness of a drug in inhibiting the EGFR turned out to be a poor proxy for how effective that drug actually was in treating cancer in vivo (i.e., in the body). Numerous EGFR inhibitors that showed promising in vitro activity failed for a variety of reasons. Id. at 1377; see also id. at 1386 (“1,630 other new drug compounds that, like erlotinib, targeted NSCLC and were studied in Phase II trials. The failure rate for these compounds was 99.5%”). Against this backdrop, the court reversed the Board over its unsupported reading of the two cited references, finding that: the asserted references do not disclose any data or other information about erlotinib’s efficacy in treating NSCLC. The record does not contain any clinical (human) data or preclinical (animal) data. It does not even include in vitro (test tube) data regarding erlotinib’s effect on NSCLC. Id. at 1384. Considering the promising in vitro data presented in Campana and Jensen, Petitioner here has a somewhat better position than the Appellees in OSI Pharms. At core, Grounds 1 and 2, require us to find a reasonable expectation of success in treating a human cancer based on in vitro experiments, the mere existence of a clinical trial, and absent any of the “clinical (human) data or preclinical (animal) data,” highlighted by the court. See id. Considering the inherent unpredictability of the field and the history of failures of similar technology documented by Patent Owner, we do not find Petitioner’s arguments persuasive. As such, Petitioner has not demonstrated a reasonable likelihood of success in proving that any claim of the ’140 patent is unpatentable under Grounds 1 and 2.” slip op. at 40

  Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
  Patents in suitUS 9,464,140
• ADT LLC v. Vivint, Inc.Institution denied
  PTAB · Aug 22, 2022 · IPR2022-00612 · APJ Charles J Boudreau · IPR · Institution

  The Board denied institution on all challenged claims under § 325(d), finding substantially the same art had been considered and no material examiner error was shown.

  RulingsInstitution decision

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied

    “Because (1) Saylor ’265 was made of record by the examiner and contains essentially the same disclosure as Saylor, (2) we find that the disclosures of Gregory relied upon by Petitioner are duplicative of Kellen and Thomson evaluated and distinguished during examination, and (3) Petitioner extensively relies on Saylor and Gregory in each of the asserted grounds of unpatentability, we determine that the Petition presents the same or substantially the same prior art that was previously presented to” slip op. at 22

  • Skill levelSkill level petitioner adoptedOther

    “the time of the alleged invention would have had at least a bachelor’s degree in computer science, electrical engineering, or computer engineering (or equivalent experience), and at least two years of professional experience in remote monitoring and control systems, Internet of Things (‘IoT’), home security systems, building automation systems, machine-to-machine (‘M2M’) communications, or other similarly relevant industry experience.” Pet. 6 (citing Ex. 1009 ¶ 25). Patent Owner does not provide its own assessment regarding the level of skill in the art, or otherwise dispute Petitioner’s assertion. See Prelim. Resp. Based on our review of the record at this stage, we find that Petitioner’s proposal is consistent with the level of skill reflected in the prior art references of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007) (listing the type of problems encountered in the art, prior art solutions to those problems, and the sophistication of the technology as factors that may be considered in determining the level of ordinary skill in the art). See also Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown”). we adopt Petitioner’s definition of the person of ordinary skill in the art.” slip op. at 11

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

    “Neither party proposes specific claim constructions for any terms. Pet. 5; see Prelim. Resp. On this record, we determine that no terms or phrases in the claims require express construction. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 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))).” slip op. at 12

  Claim constructionDiscretionary denial
  Patents in suitUS 9,349,262

Holdings, summaries, rulings, issues, outcomes, winners and claim constructions shown for a decision were generated by a large language model reading the opinion. They are a guide to the decision, not the decision. Confirm every one against the court's own text before relying on it. Outcomes read from the patent owner’s side. Party names are extracted from the decision and are missing on about 900 short Director denials and scans, which carry the trial number instead.