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  • PTAB · Dec 1, 2023 · PGR2022-00025 · APJ Susan L C Mitchell · PGR · Remand

    The Board granted PGR of claims 1–19, finding claim 1 more likely than not anticipated by Grigoriadis and claims 1–19 more likely than not lacking written-description support.

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

      “Institution of post-grant review is authorized by statute only when “the information presented in the petition . . . demonstrate[s] that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324; see 37 C.F.R. § 42.4. Upon considering the Petition, Patent Owner Preliminary Response, and the cited evidence in light of the Director’s Decision, we conclude that Petitioner has satisfied its burden under 35 U.S.C. § 324 to show that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable. Therefore, we grant institution of a post-grant review.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “B. Person of Ordinary Skill in the Art Factual indicators of the level of ordinary skill in the art include “the various prior art approaches employed, the types of problems encountered in the art, the rapidity with which innovations are made, the sophistication of the technology involved, and the educational background of those actively working in the field.” Jacobson Bros., Inc. v. U.S., 512 F.2d 1065, 1071 (Ct. Cl. 1975); see also Orthopedic Equip. Co. v. U.S., 702 F.2d 1005, 1011 (Fed. Cir. 1983) (quoting with approval Jacobson Bros.).” slip op. at 7

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for petitioner

      “Independent claim 1 recites a method of treating CAH by reducing an A4 level “from baseline” after administering a CRF1 receptor antagonist to a CAH patient. See Ex. 1001, 47:51–48:5. The Specification expressly teaches that, with respect to the clinical phase 2 trial described in Example 4, “Patients will have overnight [pharmacokinetic/pharmacodynamics] PK/PD assessments performed at baseline, which include an [sic] pre-dose overnight assessment and a post-dose overnight assessment for PK/PD following administration of the first dose.” Ex. 1001, 41:55–59. This is the same quotation and clinical trial relied upon by Dr. Barnes in his Declaration, and is the only definition of a “baseline” in the ’201 patent. See Ex. 1037, 36–37. We note that placebos were evidently not employed in the phase 2 clinical study of Example 4.5 Given the sole exemplary description of “baseline” in Example 4 of the Specification, we construe the claim term reciting “reduced from baseline” as meaning “a reduction in A4 level compared to an A4 level measurement made prior to, and/or at the beginning of, administration of the drug.”” slip op. at 10

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Reference is prior artInstituted

      “A claim is unpatentable as anticipated under 35 U.S.C. § 102 only when “every element and limitation of the claim was previously described in a single prior art reference, either expressly or inherently, so as to place a person of ordinary skill in possession of the invention.” Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075, 1082 (Fed. Cir. 2008). A reference may inherently anticipate if a claim limitation that is not expressly disclosed “is necessarily present, or inherent, in the single anticipating reference.” Verizon Servs. Corp. v. Cox Fibernet Va., Inc., 602 F.3d 1325, 1337 (Fed. Cir. 2010). Thus, the “very essence of inherency is that one of ordinary skill in the art would recognize that a reference unavoidably teaches the property in question.” Agilent Technologies, Inc. v. Affymetrix, Inc., 567 F.3d 1366, 1383 (Fed. Cir. 2009) (emphasis added).” slip op. at 23

    Claim construction§ 102 anticipation§ 112 disclosureDiscretionary denialcites Phillips
    Patents in suitUS 11,007,201
  • PTAB · Dec 1, 2023 · PGR2021-00088 · APJ John G New · PGR · Remand

    The Board instituted PGR on claims 1–25 on all five grounds, finding the threshold met based on likely anticipation, obviousness, and lack of written-description support.

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

      “Under 35 U.S.C. § 324, the Board “may not authorize a post-grant review to be instituted 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.” In conformance with the Director’s Decision, and for the reasons we explain herein, we institute post-grant review of the ’908 patent.” slip op. at 2

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for petitioner

      “The Specification expressly teaches that, with respect to the clinical phase 2 trial described in Example 4, “Patients will have overnight [pharmacokinetic/pharmacodynamics] PK/PD assessments performed at baseline, which include an [sic] pre-dose overnight assessment and a post-dose overnight assessment for PK/PD following administration of the first dose.” Ex. 1001, col.42, ll. 12–16. This is the same quotation and clinical trial relied upon by Dr. Barnes in his Declaration, and is the only definition of a “baseline” in the ’908 patent. See Ex. 1002, 36–37. We note that placebos were evidently not employed in the phase 2 clinical study of Example 4.3 Given the sole exemplary description of “baseline” in Example 4 of the Specification, we construe the claim term reciting “reduced by at least 10% from baseline” as meaning “a reduction of at least 10% in the level of ACTH (claim 1) or 17-OHP (claim 11) compared to measurements of ACTH or 17-OHP made prior to, and/or at the beginning of, administration of the drug.”” slip op. at 10

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner contends that a person of ordinary skill in the art would typically possess a medical degree or a Ph.D. in a field related to endocrinology, and would have knowledge of hormone regulation and disorders, as well as knowledge of the treatment regimens employed to treat such disorders. Pet. 60 (citing Ex. 1005 ¶ 34). Petitioner argues that such a person of ordinary skill would also have at least three years of experience conducting research concerning endocrine disorders, including CAH or other adrenal disorders. Id. Patent Owner does not expressly contest this definition of a person of ordinary skill in the art in its Preliminary Response. For the purposes of this Decision, because we find Petitioner’s definition to be consistent with the demonstrable level of skill in the art (see, e.g., Exs. 1009, 1025, 2003, 2004,” slip op. at 11

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency foundInstituted

      “A claim is unpatentable as anticipated under 35 U.S.C. § 102 only when “every element and limitation of the claim was previously described in a single prior art reference, either expressly or inherently, so as to place a person of ordinary skill in possession of the invention.” Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075, 1082 (Fed. Cir. 2008). A reference may inherently anticipate if a claim limitation that is not expressly disclosed “is necessarily present, or inherent, in the single anticipating reference.” Verizon Servs. Corp. v. Cox Fibernet Va., Inc., 602 F.3d 1325, 1337 (Fed. Cir. 2010). Thus, the “very essence of inherency is that one of ordinary skill in the art would recognize that a reference unavoidably teaches the property in question.” Agilent Technologies, Inc. v. Affymetrix, Inc., 567 F.3d 1366, 1383 (Fed. Cir. 2009) (emphasis added).” slip op. at 23

    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips
    Patents in suitUS 10,849,908
  • PTAB · Feb 22, 2023 · IPR2019-01200 · APJ Lynne E Pettigrew · IPR · Remand

    The Board granted the parties’ joint motion and terminated the remanded proceedings concerning claim 20 because the Board had not yet decided the remanded merits.

    RulingsRemand decision
    • RemandGranted

      “Generally, the Board expects that a proceeding will terminate after the filing of a settlement agreement, unless the Board already has decided the merits of the proceeding. PTAB Consolidated Trial Practice Guide, 86 (Nov. 2019).6 Here, although the Board already has issued a Final Written Decision, the Federal Circuit reversed the part of that decision addressing claim 20 of the ’552 patent and remanded to the Board for further proceedings regarding claim 20. The Board has not issued a decision on remand and, thus, has not decided the merits of the issues that were remanded to the Board. Under these circumstances, we determine it is appropriate to grant the Motion and terminate the proceedings.” slip op. at 3

    • PTAB / AIA Trials › Other PTAB motions (exclude, strike, seal, additional discovery, rehearing)Granted in part

      “The parties also jointly request that the Agreement be treated as business confidential information and be kept separate from the files of the ’552 patent and these proceedings. Req. 2. We have reviewed the Agreement, which contains confidential business information regarding the settlement terms, and we determine that good cause exists to treat the Agreement as business confidential information pursuant to 35 U.S.C. § 317(b) and 37 C.F.R. § 42.74(c) and keep it separate from the files of the ’552 patent and these proceedings. Accordingly, we grant this aspect of the parties’ Joint Request. The parties also “request that the Board order that in the event a person or entity makes a written request, as stated in 37 C.F.R. § 42.74(c)(1)-(2), for access to the settlement agreement, that any such written request be served upon Patent Owner and Petitioner on the day the written request is provided to the Board.” Req. 2. However, neither the statute nor the regulation provides for any such notification, and the parties have not provided any reason or special circumstance that would justify issuing an order that purports to impose an additional requirement. Accordingly, we deny that portion of the parties’ Joint Request.” slip op. at 4

    None
    Patents in suitUS 7,247,552
  • PTAB · Feb 22, 2023 · IPR2019-01199 · APJ Lynne E Pettigrew · IPR · Remand

    On remand, the Board terminated the proceedings after settlement because it had not decided the remanded merits concerning claim 20.

    RulingsRemand decision
    • RemandGranted

      “Generally, the Board expects that a proceeding will terminate after the filing of a settlement agreement, unless the Board already has decided the merits of the proceeding. PTAB Consolidated Trial Practice Guide, 86 (Nov. 2019).6 Here, although the Board already has issued a Final Written Decision, the Federal Circuit reversed the part of that decision addressing claim 20 of the ’552 patent and remanded to the Board for further proceedings regarding claim 20. The Board has not issued a decision on remand and, thus, has not decided the merits of the issues that were remanded to the Board. Under these circumstances, we determine it is appropriate to grant the Motion and terminate the proceedings.” slip op. at 3

    • PTAB / AIA Trials › Other PTAB motions (exclude, strike, seal, additional discovery, rehearing)Granted in part

      “The parties also jointly request that the Agreement be treated as business confidential information and be kept separate from the files of the ’552 patent and these proceedings. Req. 2. We have reviewed the Agreement, which contains confidential business information regarding the settlement terms, and we determine that good cause exists to treat the Agreement as business confidential information pursuant to 35 U.S.C. § 317(b) and 37 C.F.R. § 42.74(c) and keep it separate from the files of the ’552 patent and these proceedings. Accordingly, we grant this aspect of the parties’ Joint Request. The parties also “request that the Board order that in the event a person or entity makes a written request, as stated in 37 C.F.R. § 42.74(c)(1)-(2), for access to the settlement agreement, that any such written request be served upon Patent Owner and Petitioner on the day the written request is provided to the Board.” Req. 2. However, neither the statute nor the regulation provides for any such notification, and the parties have not provided any reason or special circumstance that would justify issuing an order that purports to impose an additional requirement. Accordingly, we deny that portion of the parties’ Joint Request.” slip op. at 4

    None
    Patents in suitUS 7,247,552
  • PTAB · Feb 22, 2023 · IPR2019-01198 · APJ Lynne E Pettigrew · IPR · Remand

    The Board granted the parties’ joint motion and terminated the remanded proceedings; it also granted in part their request to protect the settlement agreement.

    RulingsRemand decision
    • RemandGranted

      “Generally, the Board expects that a proceeding will terminate after the filing of a settlement agreement, unless the Board already has decided the merits of the proceeding. PTAB Consolidated Trial Practice Guide, 86 (Nov. 2019).6 Here, although the Board already has issued a Final Written Decision, the Federal Circuit reversed the part of that decision addressing claim 20 of the ’552 patent and remanded to the Board for further proceedings regarding claim 20. The Board has not issued a decision on remand and, thus, has not decided the merits of the issues that were remanded to the Board. Under these circumstances, we determine it is appropriate to grant the Motion and terminate the proceedings.” slip op. at 3

    • PTAB / AIA Trials › Other PTAB motions (exclude, strike, seal, additional discovery, rehearing)Granted in part

      “business confidential information and be kept separate from the files of the ’552 patent and these proceedings. Req. 2. We have reviewed the Agreement, which contains confidential business information regarding the settlement terms, and we determine that good cause exists to treat the Agreement as business confidential information pursuant to 35 U.S.C. § 317(b) and 37 C.F.R. § 42.74(c) and keep it separate from the files of the ’552 patent and these proceedings. Accordingly, we grant this aspect of the parties’ Joint Request.” slip op. at 4

    None
    Patents in suitUS 7,247,552
  • PTAB · Jun 20, 2014 · IPR2013-00520 · APJ Karl D Easthom · IPR · Order

    The Board granted the parties’ joint motions and terminated both proceedings without a final written decision.

    RulingsOther
    • PTAB / AIA Trials › Other PTAB motions (exclude, strike, seal, additional discovery, rehearing)Granted

      “involve challenges to U.S. Patent No. 7,128,617 B2 (“the ’617 Patent”), the parties filed a joint motion to terminate the respective proceeding, along with a true copy of their written settlement agreement, made in connection therewith, in accordance with 35 U.S.C. § 317(b) and 37 C.F.R. § 42.74(b). Paper 21 (attaching Ex. 1018, written settlement agreement).2 The parties also filed a joint motion in each case to treat the settlement agreement as confidential business information under 35 U.S.C. § 317(b) and 37 C.F.R. § 42.74(c). Paper 22.” slip op. at 2

    None
    Patents in suitUS 7,128,617
  • PTAB · Apr 4, 2014 · IPR2014-00015 · APJ Brian J Mcnamara · IPR · Order

    The Board granted the parties’ joint motion to terminate the proceeding and their request to keep the settlement agreement confidential.

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

      “A decision by the Board to institute a trial has not yet been reached. Therefore, this matter was in the preliminary stages at the time the parties moved to terminate. The parties have represented that the co-pending litigation, styled Yama Capital, LLC v. Canon, Inc. and Canon USA, Inc. 1:12-cv-07159, SDNY has been dismissed with prejudice. Joint Mandatory Notice (Paper 15). The parties have not identified any other related matters and have represented that they do not contemplate any further litigation concerning the’982 Patent in the foreseeable future. Paper 14. Under these circumstances, the Board determines that it is appropriate to enter judgment1 and terminate the trial without rendering a final written decision. 37 C.F.R. § 42.72.” slip op. at 2

    None
    Patents in suitUS 6,069,982

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