• Taiwan Semiconductor Manufacturing Company Ltd. / Apple Inc. v. Marlin Semiconductor Ltd.Institution denied
  PTAB · Sep 3, 2025 · IPR2025-00848 · APJ Coke Morgan Stewart · IPR · Director review

  The Director denied institution in IPR2025-00848, IPR2025-00864, IPR2025-00865, and IPR2025-00879 under § 314(a), citing ITC overlap and settled expectations.

  RulingsDirector review decision

  • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied fintivDenied

    “In particular, the projected final written decision due date for each of these cases is November 15, 2026. The hearing in the parallel U.S. International Trade Commission (“ITC”) investigation is set for February 2, 2026. DD Req. 14. As such, it is unlikely that a final written decision in these proceedings will issue before the ITC trial occurs, resulting in significant duplication of effort, additional expense for the parties, and a risk of inconsistent decisions. In addition, the patents challenged in IPR2025- 00848, IPR2025-00864, IPR2025-00865, and IPR2025-00879 have been in force for seven, nine, nine, and ten years, respectively, creating strong settled expectations for Patent Owner, and Petitioner does not provide persuasive reasoning why an inter partes review is an appropriate use of Board resources.  Dabico Airport Sols. Inc. v. AXA Power ApS, IPR2025- 1 Citations are to papers in IPR2025-00847. The parties filed similar papers in IPR2025-00848, IPR2025-00864, IPR2025-00865, and IPR2025-00879. 00408, Paper 21 at 2–3 (Director June 18, 2025). These factors favor discretionary denial.” slip op. at 2

  • Settled expectationsInstitution denied settled expectationsDenied

    “these cases is November 15, 2026. The hearing in the parallel U.S. International Trade Commission (“ITC”) investigation is set for February 2, 2026. DD Req. 14. As such, it is unlikely that a final written decision in these proceedings will issue before the ITC trial occurs, resulting in significant duplication of effort, additional expense for the parties, and a risk of inconsistent decisions. In addition, the patents challenged in IPR2025- 00848, IPR2025-00864, IPR2025-00865, and IPR2025-00879 have been in force for seven, nine, nine, and ten years, respectively, creating strong settled expectations for Patent Owner, and Petitioner does not provide persuasive reasoning why an inter partes review is an appropriate use of Board resources.  Dabico Airport Sols. Inc. v. AXA Power ApS, IPR2025- 1 Citations are to papers in IPR2025-00847. The parties filed similar papers in IPR2025-00848, IPR2025-00864, IPR2025-00865, and IPR2025-00879. 00408, Paper 21 at 2–3 (Director June 18, 2025). These factors favor discretionary denial.” slip op. at 2

  • Other 314aInstitution denied discretionary otherDenied

    “Petitioner argues that national security, economic, and public interest considerations counsel against discretionary denial because “[t]he semiconductor chips manufactured by TSMC are vital to leading U.S. companies (from Apple and NVIDIA to Amazon and Tesla) . . . and national security and defense through TSMC’s CyberShuttle program.” DD Opp. 31. Petitioner, however, does not explain in sufficient detail why review of the challenged patents is in the interest of national security, the economy, or the public. That is, Petitioner’s arguments are not narrowly-tailored towards particular products or manufacturing methods, and Petitioner does not sufficiently explain how national security, economic, or public interests warrant review of the specific patents challenged in these proceedings.” slip op. at 3

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied

    “circumstances. In particular, Petitioner provides persuasive reasoning, supported by evidence, that the Office erred in a manner material to the patentability of the challenged patent during patent examination, and, accordingly, discretionary denial under 35 U.S.C. § 325(d) is not appropriate. Specifically, during prosecution of the challenged patent, the patent examiner applied Chien7702 to reject the claims, but subsequently allowed the claims after the applicant amended them. DD Opp. 5–6. Petitioner persuasively demonstrates that the patent examiner overlooked 2 US Pat. 6,815,770, Nov. 9, 2004 (Ex. 1037). certain teachings in Chien770 that appear to disclose the claimed features that the patent examiner indicated were not taught by the prior art of record, including Chien770. Id. at 7–10. Although the challenged patent has been in force for fifteen years, Petitioner appears to show a material error by the Office, and it is an appropriate use of Office resources to review the potential error.” slip op. at 3

  Discretionary denial
  Patents in suitUS 9,953,880
• Amgen Inc. v. Bristol-Myers Squibb CompanyInstitution denied
  PTAB · Jul 24, 2025 · IPR2025-00601 · APJ Coke Morgan Stewart · IPR · Director review

  The Director denied institution in IPR2025-00601 and IPR2025-00602 based on Patent Owner’s strong settled expectations; IPR2025-00603 was referred to the Board.

  RulingsDirector review decision

  • Settled expectationsInstitution denied settled expectationsDenied

    “The patents challenged in IPR2025-00601 and IPR2025-00602 present different circumstances. In particular, the challenged patents have been in force for seven and six years, respectively, creating strong settled expectations for Patent Owner, and Petitioner does not provide persuasive reasoning why an inter partes review is an appropriate use of Board resources. Dabico Airport Sols. Inc. v. AXA Power ApS, IPR2025-00408, Paper 21 at 2–3 (Director June 18, 2025). In the absence of any such information, the Office is disinclined to disturb the strong settled expectations of Patent Owner.” slip op. at 3

  • Director reviewOther

    “Before COKE MORGAN STEWART, Acting Under Secretary of Commerce for Intellectual Property and Acting Director of the United States Patent and Trademark Office. DECISION Denying Institution of Inter Partes Review in IPR2025-00601 and IPR2025-00602 and Referring the Petition in IPR2025-00603 to the Board” slip op. at 1

  Discretionary denial
  Patents in suitUS 9,856,320
• Dabico Airport Solutions Inc. v. Axa Power ApsInstitution denied
  PTAB · Jun 18, 2025 · IPR2025-00408 · APJ Coke Morgan Stewart · IPR · Director review

  The Director granted Patent Owner’s request for discretionary denial and denied institution under § 314(a), citing the patent’s nearly eight years in force and settled expectations.

  RulingsDirector review decision

  • Settled expectationsInstitution denied settled expectationsDenied

    “those that counsel against it. In particular, the challenged patent has been in force almost eight years, creating settled expectations. See Ex. 1001. The interim processes permit a patent owner to file a brief explaining why discretionary denial is appropriate and the petitioner not only to respond to patent owner’s arguments but also to identify reasons not to exercise discretion to deny institution. As the Office has explained, “the parties are permitted to address all relevant considerations . . . bearing on the Director’s discretion.”1 The Office further has explained that “[p]arties are encouraged to address any fact or circumstance they believe bears on whether the Office should or should not institute trial.”2” slip op. at 2

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsOther

    “Some facts counsel against discretionary denial. For example, Patent Owner’s arguments regarding 35 U.S.C. § 325(d) are unpersuasive.” slip op. at 2

  • Other 314aInstitution denied discretionary otherInstitution denied

    “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

  Discretionary denial
  Patents in suitUS 9,771,169
• 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
• 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
• 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
• 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
• Boehringer Ingelheim Animal Health USA Inc. v. Kansas State University Research FoundationInstitution denied
  PTAB · Jul 15, 2022 · PGR2022-00021 · APJ Sheridan K Snedden · PGR · Institution

  The Board denied institution on Grounds 1–5 under § 325(d) and found Ground 6 had not shown any challenged claim more likely than not unpatentable.

  RulingsInstitution decision

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

    “met (e.g., substantially the same art is presented), we move to part two of the framework, asking “whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of [the] challenged claims.” Id. at 8. Factors (c), (e), and (f) of Becton, Dickinson fall within part two of the framework. Id. at 10 (“[F]actors (c), (e), and (f) relate to whether the petitioner has demonstrated material error by the Office.”). 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 error. Id. at 8–10. “If the petitioner fails to show that the Office erred, the Director may exercise his discretion not to institute.” Id. at 8–9. “At bottom, this [§ 325(d)] framework reflects a commitment to defer to previous Office evaluations of the evidence of record unless material error is shown.” Id. at 9 (“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.”).” slip op. at 15

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

    “specific citations to evaluate its assertions, Petitioner does not direct our attention to any portion of the Nordgren Declaration providing information on why the partial sequences disclosed by the references teach or suggest the claimed 90% sequence homology. Pet. 76, 79 (citing Ex. 1026 at VII.C, ¶¶ 247–269). For example, Dr. Nordgren’s assertion “a POSITA would anticipate natural genetic variation of PorkNW2/USA/2009 ORF2 would bring it within the scope of the Claim 1 genera” is not supported by substantial evidence. Ex. 1026 ¶ 256. Claim 1, for example, recites a PCV3 protein and does not recite partial proteins. Without knowing what portion of complete proteins are disclosed by the references, we are not persuaded that a person of ordinary skill in the art would have been able to predict the variation expected among a group of complete proteins to arrive at the claimed subject matter as is implied by Petitioner. Petitioner’s conclusory statements are insufficient to support a legal conclusion of obviousness. And while we agree with Petitioner that the protein sequences disclosed in the cited references do not necessarily have to be designated as PCV3 sequences, we determine that Petitioner has failed to meet its burden to demonstrate that any of the PCV3 deposit references teach or suggest the recited sequences within the claimed range. Pet. 79. Therefore, Petitioner has not met its burden in showing that every claimed element is taught by its cited references, and we need not reach Petitioner’s argument on motivation to combine. Accordingly, we determine that Petitioner fails to carry its burden to show that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable based on Petitioner’s Ground 6.” slip op. at 25

  • Skill levelSkill level petitioner adoptedOther

    “A person of ordinary skill in the art (or “POSITA”) in the field of the ’274 Patent in the October 2015 to October 2019 timeframe would have held a Doctorate in Veterinary Medicine (D.V.M.) or equivalent, or a Ph.D. or equivalent in immunology, vaccinology, virology, molecular biology, animal science, and/or husbandry, or a closely related field. A POSITA would also have practical knowledge of immunology, including how vaccine candidates are first identified and then subsequently developed. The knowledge may come from the POSITA’s own experience, or it may come through research or work collaborations with other experienced individuals in the medical, pharmaceutical, or biotech industry, e.g., as members of a research team or group. Pet. 16 (citing Ex. 1026 ¶ 34). Absent opposition from Patent Owner, we adopt Petitioner’s definition because it is consistent with the level of ordinary skill in the art reflected by the prior art in this proceeding. 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 11

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

    “The Board applies the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. § 282(b). 37 C.F.R. § 42.200(b) (2019). Under that standard, claim terms “are generally given their ordinary and customary meaning” as understood by a person of ordinary skill in the art at the time of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Petitioner contends that it “does not believe any term of the ’274 Patent needs to be construed in this proceeding.” Pet. 29. We agree and independently determine that it is unnecessary to expressly construe any claim term for purposes of rendering this Decision. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘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 11

  Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · Graham
  Patents in suitUS 10,954,274
• Janssen Biotech, Inc. v. The United States Of America, As Represented By The Secretary, Department Of Health & Human ServicesInstitution denied
  PTAB · Mar 2, 2022 · IPR2021-01484 · APJ Robert A Pollock · IPR · Institution

  The Board denied institution of IPR challenging claims 1–9, 13, 17, and 19 as obvious over Milone and Kalled under § 103, exercising discretion under § 325(d).

  RulingsInstitution decision

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

    “Electromedizinishe Gerӓte GmbH, IPR2019-01469, Paper 6 at 8–10 (Feb. 13, 2020) (“Advanced Bionics”) (precedential), the Board addresses § 325(d) applying a “two-part framework.” In the first part of the framework, we ask whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments 8 Available at https://www.uspto.gov/TrialPracticeGuideConsolidated. 22 previously were presented to the Office. Advanced Bionics at 8. Factors (a), (b), and (d) of Becton, Dickinson come into play under this first part of the framework. Id. at 8–10. If either condition of the framework’s first part is met (e.g., substantially the same art is presented), we move to part two of the framework, asking “whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of [the] challenged claims.” Id. at 8. Factors (c), (e), and (f) of Becton, Dickinson fall within part two of the framework. Id. at 10 (“[F]actors (c), (e), and (f) relate to whether the petitioner has demonstrated material error by the Office.”). 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 error. Advanced Bionics at 8–10. “If the petitioner fails to show that the Office erred, the Director may exercise his discretion not to institute inter partes review.” Id. at 8–9. “At bottom, this [§ 325(d)] framework reflects a commitment to defer to previous Office evaluations of the evidence of record unless material error is shown.” Id. at 9 (“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.”). B.” slip op. at 22

  • Skill levelSkill level patent owner adoptedOther

    “Patent Owner does not dispute Petitioner’s proposed definition, but states that the person of ordinary skill in the art would “[t]ypically” . . . have had an M.D. or a Ph.D. in immunology, biochemistry, cell biology, molecular biology, or a related discipline, with at least two years of experience in conducting laboratory research on chimeric T cell receptors.” Prelim. Resp. 44 (citing Ex. 2001 ¶ 20). According to Patent Owner, the ordinarily skilled artisan “would have had knowledge of the scientific literature and have skills relating to chimeric T cell receptors and methods of using such receptors” and “may have worked as part of a multidisciplinary team” and been able to draw on the specialized skills of, for example, an immunologist, and/or a clinical oncologist. See id. at 43–44. Considering the record before us, both parties present reasonable definitions of one of ordinary skill in the art. For the purpose of this proceeding, we consider one of ordinary skill in the art as having had an M.D. or a Ph.D. in immunology, biochemistry, cell biology, molecular biology, or a related discipline, with at least two years of experience in conducting laboratory research on chimeric T cell receptors and/or the use of CAR-T immunotherapy. Consistent with Patent Owner’s proposed definition, the ordinarily skilled artisan may have worked as part of a 20 multidisciplinary team and been able to draw on the specialized skills of, for example, an immunologist, and/or a clinical oncologist.” slip op. at 20

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for patent owner

    “We do not find Petitioner’s argument persuasive for the reasons set forth on pages 34–40 of the Preliminary Response. Most particularly, we note that the phrase “[a] chimeric antigen receptor (CAR)” occurs solely in the preamble of independent claim 24. Terms in a preamble, however, are not generally construed as limiting. See Allen Eng’g Corp. v. Bartell Indus., Inc., 299 F.3d 1336, 1346 (Fed. Cir. 2002). More specifically, “when the claim body describes a structurally complete invention such that deletion of the preamble phrase does not affect the structure or steps of the claimed invention,” the preamble is not considered a limitation. Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002). In the present case, we find it plausible—if not likely—that the Examiner gave no weight to the terms in the preamble of claim 24 such that the remaining language did not expressly or implicitly require either a 32 transmembrane domain, or a “T-cell activation moiety” specific to CAR constructs. The Examiner appears to have recognized, however, that CAR constructs differ from Kalled’s antibodies at least in having a transmembrane domain as expressly recited in claims 29 and 30. See Ex. 2005, 605, 745–749 (allowing amended claims). This view is underscored by the Examiner’s decision not to reject claims 34 and 38 as anticipated by Kalled. See Ex. 2005, 604. Notably, claims 34 and 38 recite SEQ ID Nos 4–12, each of which encodes a complete CAR construct and, thus, implicitly includes a transmembrane domain. See id. at 589 (claiming a CAR comprising the amino acid sequence of SEQ ID Nos: 4–12 (claim 34) or a nucleic acid encoding the same (claim 38)); Ex. 1001, 9:49–53; Ex. 2001 ¶ 92.12” slip op. at 32

  Claim constructionDiscretionary denialcites Graham
  Patents in suitUS 9,765,342

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.