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  • 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
  • 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
  • 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
  • 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
  • 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
  • PTAB · Nov 9, 2021 · IPR2021-00899 · APJ Grace Karaffa Obermann · IPR · Institution

    The Board denied institution of IPR on claims 1–17 under § 325(d), finding substantially the same art or arguments had been presented to the Office and no material examination error was shown.

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

      “discretion and deny a petition as authorized under Section 325(d). First, we consider whether the same or substantially the same prior art or arguments previously were presented to the Office. If either condition is satisfied, we assess whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of the challenged claims. Advanced Bionics, Paper 6 at 8. A non-exclusive list of factors, set forth in Becton, Dickinson and Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8 (PTAB Dec. 15, 2017) (precedential as to § III.C.5, first paragraph), guides our application of that two-part framework. Advanced Bionics, Paper 6 at 9. Those 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, Paper 8 at 17–18. “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, Paper 6 at 10.” slip op. at 19

    • Skill levelSkill level petitioner adoptedOther

      “Based on the information presented, we find the asserted prior art itself is sufficient to demonstrate the level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself can reflect the appropriate level of ordinary skill in the art). To the extent a more precise definition is required, we adopt Petitioner’s definition because, on this record, it appears consistent with the disclosures of the asserted prior art and the written description of the invention provided in the ’036 patent. Pet. 17 (Petitioner’s asserted definition of the ordinarily skilled artisan); see Prelim. Resp. 20 (reciting that definition without adopting it or proposing an alternative definition).” slip op. at 17

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

      “We construe terms in controversy only to the extent necessary to resolve the controversy. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Neither party proposes an express construction for any claim term. See Pet. 17; Prelim. Resp. 61–62. We find no claim term requires express construction in order to resolve whether to exercise our discretion and deny the Petition under Section 325(d). We discuss the scope of certain claim terms as necessary to our analysis of that issue, however, which we turn to in the next section.” slip op. at 18

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

      “factual determination that provides a primary guarantee of objectivity in an obviousness analysis. Al-Site Corp. v. VSI Int’l Inc., 174 F.3d 1308, 1324 (Fed. Cir. 1999) (citing Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966); Ryko Mfg. Co. v. Nu-Star, Inc., 950 F.2d 714, 718 (Fed. Cir. 1991)). In this Decision, we assess the asserted obviousness grounds only to the extent necessary to resolve Patent Owner’s request that we exercise our discretion and deny the Petition under Section 325(d).” slip op. at 17

    Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · Graham
    Patents in suitUS 9,849,036
  • PTAB · Nov 9, 2021 · IPR2021-00898 · APJ Grace Karaffa Obermann · IPR · Institution

    The Board denied institution under § 325(d), finding the petition relied on substantially the same art or arguments previously presented to the Office and failed to show material examination error.

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

      “discretion and deny a petition as authorized under Section 325(d). First, we consider whether the same or substantially the same prior art or arguments previously were presented to the Office. If either condition is satisfied, we assess whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of the challenged claims. Advanced Bionics, Paper 6 at 8. A non-exclusive list of factors, set forth in Becton, Dickinson and Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8 (PTAB Dec. 15, 2017) (precedential as to § III.C.5, first paragraph), guides our application of that two-part framework. Advanced Bionics, Paper 6 at 9. Those 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, Paper 8 at 17–18. “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, Paper 6 at 10.” slip op. at 19

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

      “The Board may not institute an inter partes review unless the information presented “shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). The Board has discretion to deny a request for institution when the information presented shows a petitioner raises “the same or substantially the same prior art or arguments previously presented to the Office,” for example, during patent examination. 35 U.S.C. § 325(d).” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Based on the information presented, we find the asserted prior art itself is sufficient to demonstrate the level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself can reflect the appropriate level of ordinary skill in the art). To the extent a more precise definition is required, we adopt Petitioner’s definition because, on this record, it appears consistent with the disclosures of the asserted prior art and the written description of the invention provided in the ’913 patent. Pet. 16 (Petitioner’s asserted definition of the ordinarily skilled artisan); see Prelim. Resp. 18 (reciting that definition without adopting it or proposing an alternative definition).” slip op. at 17

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

      “We construe terms in controversy only to the extent necessary to resolve the controversy. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Neither party proposes an express construction for any claim term. See Pet. 17; Prelim. Resp. 59–60. We find no claim term requires express construction in order to resolve whether to exercise our discretion and deny the Petition under Section 325(d). We discuss the scope of certain claim terms as necessary to our analysis of that issue, however, which we turn to in the next section.” slip op. at 18

    Claim constructionDiscretionary denialcites Phillips · Graham
    Patents in suitUS 9,622,913
  • PTAB · Oct 25, 2021 · IPR2021-00718 · APJ Hyun J Jung · IPR · Institution

    The Board denied institution because Petitioner did not show a reasonable likelihood of success on the Levy grounds and § 325(d) warranted denial of the Christensen ground.

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

      “Under 35 U.S.C. § 314, an inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Upon consideration of the Petition and Preliminary Response and for the reasons explained below, we do not institute an inter partes review of claims 10, 11, 13, and 15 of the ’843 patent.” slip op. at 2

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

      “v. Avid Tech, Inc., 815 F.3d 1356, 1367 (Fed. Cir. 2016) (“[T]he [Office] is permitted, but never compelled, to institute an [inter partes review] proceeding.”). Pursuant to 35 U.S.C. § 325(d), in determining whether to institute an 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.” In evaluating the exercise of discretion to deny institution under § 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 GmbH, IPR2019-01469, Paper 6, 8 (PTAB Feb. 13, 2020) (precedential). In applying the two-part framework, we consider several non- exclusive factors, including: (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 & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8 at 17–18 (PTAB Dec. 15, 2017) (precedential as to Section III.C.5, first paragraph) (“Becton, Dickinson”). Factors (a), (b), and (d) of the Becton, Dickinson factors relate to 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. Id. 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. Id. “At bottom, this framework reflects a commitment to defer to previous Office evaluations of the evidence of record unless material error is shown.” Id. at 9.” slip op. at 19

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentable

      “Based on our review of Petitioner’s relied-upon portions of Levy, Levy uses an extracted identifier, such as a broadcaster ID, and “context information” to identify an audio object. Ex. 1005 ¶¶ 15, 56. Thus, if we accepted Petitioner’s position that obtaining Levy’s “object identifier” discloses “acquir[ing] encoded third party data associated with the reception of the specific instance of the media segment in the electronic transmission,” Petitioner does not explain sufficiently how context information that is extracted and forwarded with the broadcaster ID to obtain the “object identifier” can disclose “generat[ing] data that enables the unique identification of the specific instance of acquisition of the encoded third party data.” See Pet. 57–60; Ex. 1003 ¶¶ 181–194. Petitioner does not identifier” can be acquired and generated in the manner argued by Petitioner. See Pet. 57–60; Ex. 1003 ¶¶ 181–194; see also Prelim. Resp. 36–37 (contending that Petitioner’s anticipation challenges lack particularity). As argued by Patent Owner, claim 10 requires that “generat[ing] data that enables the unique identification of the specific instance of acquisition of the encoded third party data” occur either after or at the same time as “acquir[ing] encoded third party data associated with the reception of the specific instance of the media segment in the electronic transmission.” Ex. 1001, 36:28–33. Claim 10 recites a “specific instance of acquisition of the encoded third party data” that apparently refers to the earlier-recited “acquire encoded third party data associated with the reception of the specific instance of the media segment in the electronic transmission,” and Petitioner does not address the interpretation of “acquisition” in view of the previously recited “acquire.” See Pet. 9–10, 57–60. Additionally, Petitioner’s declarant testimony does not explain further the arguments or evidence presented in the Petition and does not provide additional evidence beyond that cited in the Petition. See Ex. 1003 ¶¶ 181–194. Thus, for the reasons above, Petitioner fails to show that Levy discloses all the limitations of independent claim 10. 3. Dependent Claims 11, 13, and 15 Petitioner argues that Levy anticipates dependent claims 11, 13, and 15 with citations to the record. Pet. 65–69. Petitioner’s arguments and relied upon evidence for these claims do not remedy the deficiencies discussed above for independent claim 10. that Levy discloses all the limitations of dependent claims 11, 13, and 15 and, therefore, fails to show that Levy anticipates these claims.” slip op. at 16

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

      “4. Asserted Obviousness in view of Levy and Finley Petitioner argues that: [t]o the extent . . . that Levy does not anticipate the Challenged Claims because Levy does not disclose the complete details of the claimed database (in other words, that the difference between each claim as a whole and the prior art as a whole is the explicit recitation of the claimed database), it would have been obvious to store the object ID lookup information or purchase transaction tracking information. Pet. 69 (citing Ex. 1003 ¶ 227); see also id. (contending that Levy teaches storing a transaction log in a log file of a database). Petitioner’s arguments that Levy and Finley would have rendered obvious claims 10, 11, 13, and 15 do not further address the limitations we discussed above for claim 10, and Petitioner’s proposed modification of Levy in view of Finley does not remedy the deficiencies of Petitioner’s arguments that Levy discloses all the limitations of claim 10. Thus, for the reasons discussed above for claim 10, Petitioner fails to show that Levy and Finley teach or suggest all the limitations of claims 10, 11, 13, and 15 and, therefore, fails to show that Levy and Finley would have rendered obvious these claims. 5. Petitioner Fails to Show a Reasonable Likelihood of Prevailing As discussed above, Petitioner’s arguments and evidence fail to show that Levy anticipates claims 10, 11, 13, and 15 and fail to show that Levy and Finley would have rendered obvious these claims. Petitioner, therefore, fails to show a reasonable likelihood of prevailing in its challenges based on Levy.” slip op. at 18

    Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
    Patents in suitUS 9,584,843
  • PTAB · Oct 22, 2021 · IPR2021-00719 · APJ Hyun J Jung · IPR · Institution

    The Board denied institution because Petitioner did not show a reasonable likelihood of prevailing on the Levy grounds and § 325(d) warranted denial of the Christensen ground.

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

      “example, claim 5 recites “data that identifies a source of the data stream,” “third party encoded data,” “analysis data,” “identifying data,” and “additional data.” Ex. 1001, 34:47–35:11. Petitioner relies on Levy’s broadcaster ID as both (1) “data that identifies a source of the data stream” because it identifies the broadcaster and (2) “third party encoded data” because it originates from outside of Levy’s user device and is embedded with the broadcast. See Pet. 49. Petitioner, however, does not explain whether the Specification of the ’806 patent indicates that “data that identifies a source of the data stream” and the “third party encoded data” can refer to the same data. See id. at 48–49. Petitioner also does not explain further if one of ordinary skill in the art would understand that the asserted “data that identifies a source of the data stream” and the “third party encoded data” can be the same data. See id. Additionally, Petitioner argues that “Levy teaches finding, extracting, and decoding ‘identifiers’—including a ‘broadcaster ID.’” Pet. 48–49. Claim 5 requires “determining . . . data that identifies a source of the data stream through analysis of said data stream” and “extracting at least third party encoded data obtained from the data stream.” Ex. 1001, 34:47–35:11. By reciting another step for another type of data, claim 5 indicates by its own words that “third party data” has some difference with “data that identifies a source of the data stream.” See id.; see also Pet. 5 (arguing that “[t]erms not expressly construed should be given their plain and ordinary meaning”). “broadcaster ID” identifies the source, is encoded, and can originate from a third party, the arguments presented in the Petition and the cited evidence do not sufficiently persuade us that Levy’s finding, extracting, and decoding the broadcaster ID discloses, or that one of ordinary skill in the art would understand discloses, both the steps of “determining, using at least one processor, data that identifies a source of the data stream obtained through analysis of said data stream” and “extracting at least third party encoded data obtained from the data stream.” See Pet. 48–49; Ex. 1001, 34:47–58. The presented arguments and cited evidence may be sufficient for one step, but not both. Moreover, even if one of ordinary skill in the art understood that Levy’s broadcaster ID could be both “data that identifies a source of the data stream” and “third party encoded data,” Petitioner fails to explain sufficiently how Levy analyzes the asserted third party code to generate analysis data that includes at least an identifying data, as required by claim 5. The relied-upon portions of Levy do not disclose analyzing the broadcaster ID (i.e., the alleged third party encoded data). Ex. 1005 ¶¶ 13–15, 22, 26, 55, 56, 65, 68, Fig. 1. Petitioner does not explain why one of ordinary skill in the art would understand forwarding broadcaster ID with context information to a server discloses the step of “analyzing” third party encoded data. See Pet. 50–53. Petitioner also does not provide an interpretation of “analyzing” that supports the argument. See id. at 5–6, 50–53; see also Prelim. Resp. 38–39 (responding that Petitioner’s anticipation challenges lack particularity).” slip op. at 17

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

      “proceeding.”). Pursuant to 35 U.S.C. § 325(d), in determining whether to institute an 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.” In evaluating the exercise of discretion to deny institution under § 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, LLC v. Med-El Electromedizinishe Gerӓte GmbH, IPR2019-01469, Paper 6, 8 (PTAB Feb. 13, 2020) (precedential). In applying the two-part framework, we consider several non- exclusive factors, including: (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. Paper 8 at 17–18 (PTAB Dec. 15, 2017) (precedential as to Section III.C.5, first paragraph) (“Becton, Dickinson”). Factors (a), (b), and (d) of the Becton, Dickinson factors relate to 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. Id. 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. Id. “At bottom, this framework reflects a commitment to defer to previous Office evaluations of the evidence of record unless material error is shown.” Id. at 9.” slip op. at 21

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner asserts that one of ordinary skill in the art “would have had a B.S. in computer science or electrical engineering (or a related field), and approximately three years of experience working in the communications- or Internet-related industries, or, alternatively, an advanced degree (such as a master’s degree) in computer science or electrical engineering (or a related field).” Pet. 5 (citing Ex. 1003 ¶ 36). Petitioner also argues that “more education or skill might make up for less experience, and vice-versa.” Id. (citing Ex. 1003 ¶ 36). Patent Owner neither addresses Petitioner’s” slip op. at 9

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

      “Petitioner proposes an interpretation for “media segment” with citations to the record. Pet. 6 (citing Ex. 1001, 14:18–23; Ex. 1003 ¶¶ 42, 43). Patent Owner provides a response. Prelim. Resp. 53–54. At this stage, because determining whether Petitioner shows a reasonable likelihood of prevailing does not depend on a particular interpretation for any claim term, we determine that no claim term requires express interpretation. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (construing explicitly only those claim terms in controversy and only to the extent necessary to resolve the controversy);” slip op. at 10

    Claim constructionDiscretionary denialcites Phillips · KSR · Graham
    Patents in suitUS 9,294,806
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