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  • 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 · Apr 14, 2022 · IPR2022-00003 · APJ Juliet Mitchell Dirba · IPR · Institution

    The Board denied institution of review of claims 1–15, 23–28, 32, 43–51, and 97 under § 325(d) because substantially the same art or arguments were previously presented and Petitioner showed no material Office error.

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

      “(1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims.” slip op. at 7

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

      “We may institute an inter partes review if the information presented in the Petition and the Preliminary Response shows that there is a reasonable likelihood that Petitioner would prevail with respect to at least one of the challenged claims. See 35 U.S.C. § 314. However, the Board has discretion to deny a petition even if a petitioner meets that threshold. See, e.g., 35 U.S.C. § 325(d); Cuozzo Speed Techs., LLC v. Lee, 579 U.S. 261, 273 (2016) (“[T]he agency’s decision to deny a petition is a matter committed to the Patent Office’s discretion.”).” slip op. at 2

    Discretionary denial
    Patents in suitUS 7,630,358
  • PTAB · Apr 8, 2022 · IPR2021-01545 · APJ Neil T Powell · IPR · Institution

    The Board denied institution for claims 16–19, 21, and 23–29 under § 325(d), finding substantially the same art and arguments had been considered and Petitioner had not shown Office error.

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

      “On the whole, we find the Petition cites substantially the same art previously presented to the Office in the Third Reexamination. Patent Owner identifies extensive similarities between the art from the Third Reexamination and the art cited by the Petition. Prelim. Resp. 1, 21–24. Four out of the five references cited by the Petition are identical to the references considered in the Third Reexamination. E.g., Pet. 9–10, 71–72; Ex. 1005, 18–19; Prelim. Resp. 21–22. Although Nihei was not considered during the Third Reexamination, Petitioner does not show any material difference between Nihei and the references cited in the Third Reexamination. To the contrary, we agree with Patent Owner that Petitioner’s unpersuasive arguments about the judging consistency limitation do not demonstrate that Nihei discloses this limitation any more so than Toyofuku. Prelim. Resp. 22–23. On the whole, we find Petitioner’s arguments about Nihei less persuasive than Patent Owner’s arguments that Nihei is cumulative to the art cited during the Third Reexamination. Prelim. Resp. 1, 8–18, 22–24. Thus, Becton, Dickinson factors (a) and (b) support Patent Owner’s position that substantially the same art was presented to the Office in the Third Reexamination. Additionally, we find significant overlap between arguments made during the Third Reexamination and the manner in which Petitioner relies on the prior art cited in the Petition. In the Third Reexamination, Petitioner’s counsel cited Toyofuku as allegedly disclosing the judging consistency limitation. Ex. 1005, 58–9. Here, Petitioner also argues that a person of ordinary skill in the art would have understood that Toyofuku discloses the judging consistency limitation. Pet. 44. Thus, Becton, Dickinson factor (d) also supports Patent Owner’s position that substantially the same art and arguments were presented to the Office in the Third Reexamination. Having determined that the Petition presents substantially the same art and arguments previously presented to the Office, we proceed to part two of the Advanced Bionics inquiry.” slip op. at 23

    Discretionary denial
    Patents in suitUS 8,031,064
  • PTAB · Apr 6, 2022 · IPR2021-01562 · APJ Terrence W Mcmillin · IPR · Institution

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

    RulingsInstitution decision
    • PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner

      “interest to this proceeding. Pet. 75; Paper 9, 2. Patent Owner argues the “Petition’s identification of the real parties-in-interest is fatally defective” because “the RPI identified in the Petition is different from the real parties in interest identified in the Power of Attorney.” Prelim. Resp. 41–42 (citing Pet. 75). In an Updated Mandatory Notice, Petitioner identifies Panduit Corp., The Siemon Company, FS.Com, Inc., and Reichle & De-Massari Holding AG as the real parties in interest. Paper 17, 2. To the extent that the identification of the real parties in interest in the Petition may have been defective because it differed from Petitioner’s Powers of Attorney (see Papers 1–4), that defect has been cured in Petitioner’s Updated Mandatory Notice.” slip op. at 2

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

      “part of the Advanced Bionics framework, that the Petition “presents to the Office the same or substantially the same art previously presented to the Office.” See Advanced Bionics, IPR2019-01469, Paper 6 at 7.” slip op. at 16

    Discretionary denial
    Patents in suitUS 10,444,456
  • PTAB · Mar 22, 2022 · IPR2021-01520 · APJ Steven M Amundson · IPR · Institution

    The Board denied institution of inter partes review of claims 1, 2, 4, 9-11, 13, 18, and 19 under § 325(d), finding the same art had been evaluated and no material Office error was shown.

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

      “If “either condition of first part of the framework is satisfied,” we must then determine “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. “An example of a material error may include misapprehending or overlooking specific teachings of the relevant prior art where those teachings impact patentability of the challenged claims.” Id. at 8 n.9.” slip op. at 16

    • Other 314aNot reached

      “III. DISCRETIONARY DENIAL Patent Owner argues that we should exercise our discretion under § 314(a) or § 325(d) to deny institution. See Prelim. Resp. 13–43; Prelim. Sur-reply 1–8; 35 U.S.C. §§ 314(a), 325(d). Petitioner argues that we should decline to exercise our discretion to deny institution. See Pet. 8–12; Prelim. Reply 1–10. For the reasons explained below, we exercise our discretion under § 325(d) to deny institution. Because we exercise our discretion under § 325(d) to deny institution, we do not reach discretionary denial under § 314(a).” slip op. at 15

    Discretionary denial
    Patents in suitUS 9,686,193
  • PTAB · Mar 9, 2022 · IPR2021-01507 · APJ Grace Karaffa Obermann · IPR · Institution

    The Board denied institution of review of claims 1–3 under § 325(d), finding the petition relied on substantially the same art or arguments previously presented and did not show material Examiner error.

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

      “Becton, Dickinson factors (a), (b), and (d) 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 the prior art or arguments. Id. In general, only if the same, or substantially the same, art or arguments previously were presented to the Office, do we turn to whether Petitioner has established a material error. 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 24

    Discretionary denial
    Patents in suitUS 8,524,733
  • 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 · Feb 15, 2022 · IPR2021-01358 · APJ Kara L Szpondowski · IPR · Institution

    The Board denied institution of review of claims 1–21 under § 325(d), finding the grounds presented substantially the same art and arguments previously considered and no material Office error.

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

      “In evaluating the exercise of discretion to deny institution under Section 325(d), the Board uses the following two-part framework: (1) determining whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of the first part of the framework is satisfied, determining whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, Paper 6 at 8.” slip op. at 18

    Discretionary denial
    Patents in suitUS 9,887,795
  • PTAB · Feb 15, 2022 · IPR2021-01361 · APJ Patrick M Boucher · IPR · Institution

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

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

      “to the first part of the Advanced Bionics framework support the finding that substantially the same art and substantially the same arguments were previously presented to the Office. With respect to the second part of the Advanced Bionics framework, we find that Petitioner has not demonstrated that the Office erred in a manner material to the patentability of challenged claims. As discussed below, Petitioner does not meaningfully assess the record of examination or explain sufficiently how or why Becton, Dickinson factors (c), (e), or (f) support its positions.” slip op. at 26

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

      “III. CONCLUSION We conclude that, for each of Petitioner’s challenges, it is appropriate to exercise our discretion under 35 U.S.C. § 325(d) to deny the Petition with respect to those grounds. We accordingly exercise that discretion for the Petition as a whole and deny institution of an inter partes review. IV. ORDER In consideration of the foregoing, it is ORDERED that the Petition is denied, and no trial is instituted.” slip op. at 34

    Discretionary denial
    Patents in suitUS 10,771,181
  • PTAB · Feb 15, 2022 · IPR2021-01359 · APJ Patrick M Boucher · IPR · Institution

    The Board denied institution of IPR on claims 1–11 and 13–23 under § 325(d), finding substantially the same art and arguments were previously presented and no material Office error was shown.

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

      “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 at 8.” slip op. at 20

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

      “III. CONCLUSION We conclude that, for each of Petitioner’s challenges, it is appropriate to exercise our discretion under 35 U.S.C. § 325(d) to deny the Petition with respect to those grounds. We accordingly exercise that discretion for the Petition as a whole and deny institution of an inter partes review. IV. ORDER In consideration of the foregoing, it is ORDERED that the Petition is denied, and no trial is instituted.” slip op. at 33

    Discretionary denial
    Patents in suitUS 10,263,723

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