• 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
• Ecto World, LLC / Sv3, LLC v. Rai Strategic Holdings, Inc.Institution denied
  PTAB · Mar 6, 2025 · IPR2024-01280 · APJ Jo-Anne M Kokoski · IPR · Institution

  The Board denied institution of IPR challenging claims 1–30 because the asserted art was previously presented to the Office and Petitioner did not show material Office error.

  RulingsInstitution decision

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

    “inter partes 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.” 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 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 the 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, Dickinson1 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 8

  • Skill levelSkill level petitioner adoptedOther

    “Petitioner contends that a person of ordinary skill in the art (“POSA”) would have had “a bachelor’s degree in electrical engineering, mechanical engineering, chemistry, physics, or an equivalent field, as well as 3–4 years of industry experience, or a master’s degree in the above fields, and 1–2 “[s]uch a POSA would have been familiar with electrically powered smoking articles and/or the components and underlying technology used therein.” Id. (citing Ex. 1003 ¶ 63. Patent Owner states that, for purposes of the Preliminary Response, “Patent Owner maintains that Petitioners’ arguments fail even under Petitioners’ POSA definition.” Prelim. Resp. 13. On this record, we preliminarily adopt Petitioner’s undisputed proposed definition because it appears to be consistent with the cited prior art and the disclosure of the ’202 patent. See 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 need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). B. Claim Construction” slip op. at 6

  Discretionary denialcites Phillips
  Patents in suitUS 11,925,202
• 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
• Parse Biosciences, Inc. v. 10x Genomics, Inc.Institution denied
  PTAB · Dec 19, 2023 · IPR2023-01033 · APJ Sheridan K Snedden · IPR · Institution

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

  RulingsInstitution decision

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

    “the following two-part framework: (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, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6, 8 (PTAB Feb. 13, 2020) (precedential). The Becton, Dickinson factors provide useful insight into how to apply the framework under 35 U.S.C. § 325(d). Id. at 9 (referencing Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8, 17– 18 (PTAB Dec. 15, 2017) (precedential as to § III.C.5, first paragraph)).” slip op. at 12

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

    “presented to the Office, and (2) Petitioner has not demonstrated that the Office erred. We therefore conclude that it is appropriate to exercise discretion under 35 U.S.C. § 325(d) to deny the Petition. III. CONCLUSION For the foregoing reasons, we exercise discretion under 35 U.S.C. § 325(d) to deny institution of an inter partes review. IV. ORDER In consideration of the foregoing, it is hereby: ORDERED that the Petition is denied, and no trial is instituted.” slip op. at 21

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

    “enzyme complex” and “nucleic acid insert element.” Pet. 21. Patent Owner, for its part, states that “[n]o terms require construction for considering institution.” Prelim. Resp. 18. We determine that neither of the two limitations identified by Petitioner requires an express construction for purposes of this Decision. It bears mentioning, however, that the ’357 patent states that “[t]he insertional enzyme can be a transposase.” Ex. 1001, 3:47–48. There is no dispute that Grunenwald discloses the use of a transposase and, thus, an insertional enzyme complex. See Pet. 16 (citing Ex. 1003 ¶¶ 17, 93–94, 162); Prelim. Resp. 13 (“Grunenwald further defines ‘transposase’ to mean ‘an enzyme that is capable of forming a functional complex . . . and catalyzing insertion or transposition of the transposon end-containing composition into the double-stranded target DNA with which it is incubated in an in vitro transposition reaction.” (citing Ex. 1003 ¶ 93)).” slip op. at 6

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for patent owner

    “express construction of the term “chromatin.” The ’357 patent itself provides a definition, stating: The term “chromatin,” as used herein, refers to a complex of molecules including proteins and polynucleotides (e.g. DNA, RNA), as found in a nucleus of a eukaryotic cell. Chromatin is composed in part of histone proteins that form nucleosomes, genomic DNA, and other DNA binding proteins (e.g., transcription factors) that are generally bound to the genomic DNA. Ex. 1001, 12:61–67. This is the meaning that we apply in this Decision.” slip op. at 6

  Claim constructionDiscretionary denial
  Patents in suitUS 10,738,357
• 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
• Keysight Technologies, Inc. v. Centripetal Networks, Inc.Institution denied
  PTAB · Mar 22, 2023 · IPR2022-01421 · APJ Kevin F Turner · IPR · Institution

  The Board denied institution on all challenged claims under § 325(d), finding the art and arguments substantially the same as those previously presented and no material Office error shown.

  RulingsInstitution decision

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

    “[a] two-part framework: (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 2 U.S. Patent Publication No. 2006/0048142 A1 (filed Sept. 2, 2004) (published Mar. 2, 2006) (Ex. 1005, “Roese”). 3 K. Golnabi et al., Analysis of Firewall Policy Rules Using Data Mining Techniques, 2006 IEEE/IFIP Network Operations and Management Symposium, NOMS 2006, 10th IEEE/IFIP, 305–315 (2006) (Ex. 1008, “Golnabi”). 4 U.S. Patent Publication No. 2004/0015905 A1 (filed Oct. 26, 2001) (published Jan. 22, 2004) (Ex. 1006, “Huima”). 5 U.S. Patent No. 7,320,022 B2 (filed July 25, 2002) (issued Jan. 15, 2008) (Ex. 1007, “Hayter”). 6 U.S. Patent No. 5,226,141 (filed Nov. 18, 1991) (issued July 6, 1993) (Ex. 1009, “Esbensen”). 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 7

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

    “We are not persuaded by Petitioner’s assertion that, because the first prong of the Advanced Bionics test is met, Petitioner was not required to address the second step of the test. Patent Owner disclosed the ’148 FWD to the Examiner in an IDS and the Examiner acknowledged it. Under these circumstances, it was incumbent on Petitioner to demonstrate that the Office erred in a manner material to patentability of the challenged claims. Instead, Petitioner cabined its arguments to the Examiner not having considered the art and arguments. As the Examiner acknowledged the IDS disclosing the ’148 FWD and Petitioner did not plead material error, it is appropriate for us to exercise our discretion under 35 U.S.C. § 325(d) to deny institution, without further reaching the merits.” slip op. at 10

  • BurdenDecided for patent owner

    “was provided via an Information Disclosure Statement (IDS). See Advanced Bionics, Paper 6 at 7–8. Patent Owner also asserts that Petitioner has the burden of affirmatively demonstrating that the Office committed material error in issuing the challenged patent, and the Petition makes no allegation of error by the Office. Prelim. Resp. 12 (citing Pet. 9). We are not persuaded by Petitioner’s assertion that, because the first prong of the Advanced Bionics test is met, Petitioner was not required to address the second step of the test. Patent Owner disclosed the ’148 FWD to the Examiner in an IDS and the Examiner acknowledged it. Under these circumstances, it was incumbent on Petitioner to demonstrate that the Office erred in a manner material to patentability of the challenged claims. Instead, Petitioner cabined its arguments to the Examiner not having considered the art and arguments. As the Examiner acknowledged the IDS disclosing the ’148 FWD and Petitioner did not plead material error, it is appropriate for us to exercise our discretion under 35 U.S.C. § 325(d) to deny institution, without further reaching the merits.” slip op. at 10

  Discretionary denial
  Patents in suitUS 10,681,009
• Risen (Suzhou) Pharma Tech. Co. Ltd. v. Alzheon, Inc.Institution denied
  PTAB · Jan 13, 2023 · PGR2022-00051 · APJ Jamie T Wisz · PGR · Institution

  The Board denied institution on all challenged claims, finding no reasonable likelihood of unpatentability under §§ 101 and 112(a), and denying Grounds 4–6 under § 325(d).

  RulingsInstitution decision

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

    “unless . . . the information presented in the petition . . . , if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” Upon considering the arguments and evidence, we determine that the information presented fails to demonstrate it is more likely than not that at least one of the challenged claims of the ’742 patent is unpatentable for ineligibility, lack of written description, or non-enablement. We also exercise our discretion to deny institution of post-grant review under 35 U.S.C. § 325(d). slip op. at 2

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

    “tramiprosate “showed a significant overall treatment effect” in “an APOE4+ sub-group,” including APOE4 homozygotes; “therapeutic interventions applied earlier in the course of AD more likely might achieve the goal of disease modification;” and that “AD would be optimally treated before significant cognitive impairment, during its pre-symptomatic or pre-clinical stages …”) (emphases removed). Accordingly, Caltagirone was previously presented to the Office and we also find that Caltagirone’s disclosures are substantially similar to, or cumulative of, other references previously considered by the Examiner.” slip op. at 49

  • Adverse judgmentAdverse judgmentOther

    “D. Statutory Disclaimer After the filing of the Petition in this proceeding, Patent Owner filed a statutory disclaimer, disclaiming claims 9 and 11–15 of the ’742 patent, effective October 7, 2022. Prelim. Resp. 12; Ex. 2001, 1. “No post-grant review will be instituted based on disclaimed claims.” 37 C.F.R. § 42.207(e). We do not analyze the validity of claims 9 and 11–15 based on Petitioner’s challenges (e.g., Grounds 2 and 3) because these claims have been statutorily disclaimed.” slip op. at 5

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “at least an M.D. or Ph.D. degree in a biomedical science or equivalent field. They would also have several years of clinical experience treating and/or conducting clinical trials of drugs for AD patients, or professional experience working in clinical trial design and execution related to drugs for AD or supervising such work. Pet. 14–15 (citing Ex. 1003 ¶ 62) (internal citation omitted). Patent Owner does not contest the characterization offered by Petitioner. Prelim. Resp. 12–13. For purposes of this Decision, we adopt Petitioner’s characterization as it is consistent with the level of skill in the art at the time of the invention as reflected by the ’742 patent and the cited prior art. See 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” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 9

  Claim construction§ 101 eligibility§ 112 disclosureDiscretionary denialcites Alice · Mayo · Graham
  Patents in suitUS 11,191,742
• Risen (Suzhou) Pharma Tech. Co. Ltd. v. Alzheon, Inc.Institution denied
  PTAB · Jan 9, 2023 · IPR2022-01200 · APJ Devon Zastrow Newman · IPR · Institution

  The Board denied institution for claims 1–14 under § 325(d), finding the petition relied on substantially the same art and arguments previously presented and did not show material examiner error.

  RulingsInstitution decision

  • Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalDisclaimer foundDecided for patent owner

    “ApoE4+ patient with AD using tramiprosate over the Caltagirone reference, which disclosed treatment of ApoE4+ “all-comers” (containing at least one ApoE4 allele, either heterozygous or homozygous) with tramiprosate. See, e.g., Ex. 1002, 204–208. When Patent Owner responded to the Examiner by highlighting data (i.e., Figure 8 of the specification giving rise to the ’029 patent) showing a notable increase in cognitive function in patients with two ApoE4 alleles (homozygous) who were administered tramiprosate as compared to the ApoE4 “all-comers” (mixed homozygous/heterozygous population), the Examiner suggested narrowing the pending claims to treatment of ApoE4 homozygotes. Ex. 1002, 342. Patent Owner submitted amended claims requiring selection of patients for treatment who were homozygous for ApoE4, and argued: The presently amended claims . . . select only ApoE4 homozygotes for treatment with tramiprosate or a prodrug thereof, necessarily omitting ApoE4 heterozygotes from such treatment. . . . Caltagirone fails to teach or suggest a patient selection strategy that would limit tramiprosate treatment to patients having two ApoE4 alleles and, in fact, teaches away from such selection. Kong fails to contradict or overcome these deficiencies in Caltagirone. Kong does not refer to any patient selection strategy, much less one that would limit tramiprosate prodrug treatment to ApoE4 homozygotes. The Office's reliance on Kong is solely for its teaching of a tramiprosate prodrug. Thus, the combination of Caltagirone and Kong, taken under the Office’s interpretation, suggests treatment of all ApoE4+ patients with a prodrug of tramiprosate. This falls far short of suggesting the presently claimed patient selection and treatment strategy which selects only ApoE4 homozygotes for treatment and does not treat ApoE4 heterozygotes. Id. at 338–39 (emphasis added). The Examiner acknowledged the” slip op. at 16

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner asserts that a person of ordinary skill in the art (“skilled artisan”) at the time of the invention would have had at least an M.D. or Ph.D. degree in a biomedical science or equivalent field. They would also have several years of clinical experience treating and/or conducting clinical trials of drugs for AD patients, or professional experience working in clinical trial design and execution related to drugs for AD or supervising such work. Pet. 19 (citing Ex. 1003 ¶¶ 52–53). Patent Owner does not contest the characterization offered by Petitioner. Prelim. Resp. 14–15. For purposes of this Decision, we adopt Petitioner’s characterization as it is consistent with the level of skill in the art at the time of the invention as reflected by the ’029 patent and the cited prior art. See 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” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 12

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

    “whether the art or arguments presented in the Petition are the same or substantially the same as those previously presented to the Office (Advanced Bionics, Paper 6 at 10). Factors (c), (e), and (f) “relate to whether the petitioner has demonstrated a material error by the Office” in its prior consideration of that art or arguments (Advanced Bionics, Paper 6 at 10). Only if the same or substantially the same art or arguments were previously presented to the Office do we then consider whether petitioner has demonstrated a material error by the Office (Advanced Bionics, Paper 6 at 10). “At bottom, this framework reflects a commitment to defer to previous Office evaluations of the evidence of record unless material error is shown” (Advanced Bionics, Paper 6 at 9).” slip op. at 21

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

    “Babic ascertained that “different effects of a drug could be observed in different subpopulations of patients based on ApoE4 carrier status”” and that “drug effects in homozygous carriers could be greater than those in the heterozygous carriers and non-carriers who did not respond to the drug.” Ex. 1003 ¶ 107. As stated, this testimony does not support Petitioner’s contention that an ordinary artisan would have been motivated “to select homozygous ApoE4 carriers for treatment with any drug for which response has been correlated to ApoE4 carrier status.” See Pet. 41 (emphasis added). In particular, we find an insufficient factual basis for Petitioner’s contention that results obtained for galantamine, an acetylcholinesterase inhibitor (Ex. 1003 ¶ 105) would have motivated an ordinary artisan to replace the galantamine taught in Babic with tramiprosate (homotaurine), a GABA receptor agonist that works by a different mechanism (Ex. 1007, 582). We have also considered Dr. Ruffalo’s testimony that the ordinary artisan would have been motivated to replace Babic’s galantamine with tramiprosate as taught in Caltagirone or Val-APS as taught in Kong. Ex. 1003 ¶¶ 276–277. Dr. Ruffalo posits that Babic’s disclosures would have motivated the ordinary artisan to analyze Caltagirone’s data to ascertain if tramiprosate is more effective in homozygotes, and to replace galantamine with tramiprosate or Val-APS as taught in Kong because of their improved safety profiles as compared to galantamine, and because the replacement drugs target the underlying disease and not symptom amelioration as does galantamine. Id. Dr. Ruffalo also posits that the prior art would have imparted the following knowledge to the ordinary artisan: because the effect of tramiprosate was dependent on the required ApoE4 allele, homozygotes having the highest number of ApoE4 allele copies would derive, at the very least, as much benefit as from the drug as the heterozygotes having only one copy of the allele, and most likely the homozygotes would have the greatest therapeutic response to tramiprosate since they have the maximum number of copies of the required allele. Having done this simple assessment, A POSA would conclude that tramiprosate would be expected to exhibit a greater therapeutic effect in homozygotes and thus would have been motivated to treat homozygotes with tramiprosate, including in an oral dosage form as taught by Aisen. Id. Dr. Ruffalo further posits that the skilled artisan would have had a reasonable expectation of success in administering tramiprosate to treat homozygous ApoE4 patients because they “would almost certainly have the greatest response to the drug.” Id. ¶ 286. Patent Owner argues that the Examiner previously examined the issue of whether ApoE4 genotypes in treatment decisions should be considered during prosecution, with respect to Caltagirone, where ApoE4 genotypes were included, and Sleegers (Ex. 1002, 685, 1137), where studies led away from such inclusion. Prelim. Resp. 30–31. We find Sleegers’ disclosure” slip op. at 29

  Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · Graham
  Patents in suitUS 10,471,029
• 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
• Alarm.Com, Inc. v. Vivint, Inc.Institution denied
  PTAB · Nov 1, 2022 · IPR2022-00728 · APJ Charles J Boudreau · IPR · Institution

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

  RulingsInstitution decision

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

    “GMBH, IPR2019-01469, Paper 6 (PTAB Feb. 13, 2020) (precedential) (“Advanced Bionics”), the Board applied a two-part framework in considering whether to exercise discretion to deny institution 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, Paper 6 at 8.” slip op. at 17

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

    “After considering the Petition and associated evidence, we exercise” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “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”). Accordingly, for purposes of this decision and to the extent necessary, we adopt Petitioner’s definition of the person of ordinary skill in the art.” slip op. at 12

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

    “Petitioner does not propose constructions for any claim terms. See Pet. 6 (citing 37 C.F.R. § 42.100(b)). 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 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.