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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 · Apr 18, 2023 · IPR2022-00123 · APJ Zhenyu Yang · IPR · Final written decision

    The Board cancelled original claim 1 and denied substitute claim 2 for lack of written-description support; it did not reach the obviousness or enablement grounds.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “ordinary skill is inappropriate because it “requires qualifications that exclude even the sole inventor of the ’190 Patent, Dr. Edward Neuwelt.” MTA Opp. 1. According to Petitioner, Dr. Neuwelt is “a neurosurgeon,” not a pediatric oncologist, and lacks the requisite “at least 2 years” experience in platinum-based therapies. Id. (citing Ex. 1003, 18; Ex. 1038, 98:9–17, 100:15–101, 4). We agree with Petitioner. It is well settled that inventors are typically persons skilled in the field of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc). Petitioner presents persuasive evidence to show that under Patent Owner’s proposed definition of the level of ordinary skill, Dr. Neuwelt, the sole inventor, would not qualify as an ordinarily skilled artisan, because he is not a pediatric oncologist, even though he is considered “one of the world leading experts on this compound [STS] and otoprotection” and “an expert in the area of [STS] as a . . . drug to use in children with medulloblastoma.” Ex. 1038, 98:9–17, 99:17–18, 101:18–102:13.” slip op. at 10

    • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

      “Paragraph 102 of Dr. Rassekh’s Declaration, however, does not support Patent Owner’s assertion. Instead, Dr. Rassekh testifies that [t]he stratum of previous craniospinal radiation therapy contained 8 participants: 2 of the 4 (50%) participants receiving STS had hearing loss compared to 4 of the 4 (100%) participants not receiving STS, and none of the hearing loss assessments were changed at the 1 year follow up period. (Ex. 1001 at 20: 28-32, 47-50.) Ex. 2024 ¶ 102. Dr. Rassekh offers no opinion on how many osteosarcoma patients with prior cranial irradiation and how many medulloblastoma patients with prior cranial irradiation had hearing loss.” slip op. at 20

    • 112 supportMotion to amend, deniedDenied

      “In sum, we find the disclosures of the ’243 application that Patent Owner relies on do not provide sufficient written-description support for the ototoxicity efficacy limitation.” slip op. at 21

    • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not reached

      “F. Petitioner’s Asserted Unpatentability Grounds In light of our determination above that Patent Owner has not shown sufficient written-description support for proposed substitute claim 2 in the ’243 application, we do not reach the grounds of unpatentability set forth in Petitioner’s Opposition. See Revised MTA Opp. 17–25 (alleging non-enablement and obviousness).” slip op. at 26

    § 103 obviousness§ 112 disclosurecites Phillips
    Patents in suitUS 10,596,190
  • PTAB · Aug 12, 2020 · PGR2019-00032 · APJ David Cotta · PGR · Final written decision

    The Board granted cancellation of claim 8 and denied entry of substitute claim 11 because Petitioner showed it would have been obvious over Omura, Tsuji, and the knowledge of a person of ordinary skill.

    RulingsFinal written decision
    • Skill levelSkill level patent owner adoptedDecided for patent owner

      “In our Institution Decision, we agreed with the position Patent Owners took in their Preliminary Response – i.e, that the focus of the challenged claims was enzyme-based biosensors and thus the POSA would have more than just a familiarity with enzyme-based biosensors and protein chemistry. Inst. Dec. 8–9. Accordingly, based on the record before us at the time, we accepted the definition provided in Patent Owners’ Preliminary Response, which was consistent with the level of skill reflected in the asserted prior art references and in the specification of the ‘987 patent. 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). Neither party challenges the identification of the POSA set forth in our Institution Decision. See generally, R. Mot.; Opp.; Reply; Sur-reply. Additionally, we find that the fully developed trial record supports the POSA identification we made in our Institution Decision. Accordingly, in this decision, we apply the identification of the POSA set forth in our Institution Decision. Inst. Dec. 9.” slip op. at 9

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

      “Only those terms that are in controversy need be construed, and 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) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). For purposes of this decision, we need not expressly construe any claim terms.” slip op. at 10

    • PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend granted in partGranted in part

      “first, substitute claim 11 would have been obvious over Omura in view of the knowledge of the POSA, and second, substitute claim 11 would have been obvious over the combination of Omura and Tsuji in view of the knowledge of the POSA. Opp. 7–24. We have considered the question of patentability in view of all the evidence and arguments presented in this proceeding. Based on the record developed during this proceeding, we determine that Petitioner has shown by a preponderance of the evidence that substitute claim 11 would have been obvious over the combination of Omura, Tsuji, and the knowledge of the POSA. Because Petitioner has proven that substitute claim 11 would have been obvious, as discussed in detail below, we do not consider whether Patent Owners’ motion otherwise complies with the statutory and regulatory requirements for a motion to amend. See, 35 U.S.C. § 326(d)(1)(B) (requiring that the amendment propose a “reasonable number of substitute claims” and requiring that the substitute claims do “not enlarge the scope of the claims of the patent or introduce new matter”); 37 C.F.R. § 42.221 (additionally providing, inter alia, that a motion to amend “may be denied where . . . [t]he amendment does not respond to a ground of unpatentability involved in the trial”). Similarly, because we have determined that substitute claim 11 would have been obvious over the combination of Omura, Tsuji, and the knowledge of the POSA, as discussed in detail below, we do not reach the question of whether substitute claim 11 would also have been obvious over only Omura in view of knowledge of the POSA.” slip op. at 11

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable

      “includes “research experience and/or knowledge in enzymology . . . and biosensors,” we agree with Petitioner that it would have been obvious to a POSA to substitute FAD-conjugated glucose dehydrogenase derived from the claimed strain of Aspergillus oryzae for FAD-conjugated glucose dehydrogenase derived from Aspergillus terreus as disclosed in Omura.” slip op. at 18

    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 9,976,125
  • PTAB · Sep 15, 2014 · IPR2014-00470 · APJ Joni Y Chang · IPR · Order

    The Board granted the joint motions to terminate the instituted inter partes reviews as to Intel and Zond after settlement; it did not decide patentability.

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

      “Generally, the Board expects that a proceeding will terminate after the filing of a settlement agreement. See, e.g., Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012). Upon consideration of the facts before us, we determine that it is appropriate to terminate the above-identified proceedings as to both parties, and enter judgment. For the foregoing reasons, it is: ORDERED that the Joint Motions to Terminate the above-identified inter partes reviews are granted; FURTHER ORDERED that the above-identified proceedings are terminated as to all parties—namely, Intel and Zond; and” slip op. at 3

    None
    Patents in suitUS 7,811,421
  • PTAB · Sep 15, 2014 · IPR2014-00455 · APJ Joni Y Chang · IPR · Order

    The Board granted the parties’ joint motions and terminated IPR2014-00455 and IPR2014-00456 as to Intel and Zond after settlement.

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

      “Generally, the Board expects that a proceeding will terminate after the filing of a settlement agreement. See, e.g., Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012). Upon consideration of the facts before us, we determine that it is appropriate to terminate the above-identified proceedings as to both parties, and enter judgment. For the foregoing reasons, it is: ORDERED that the Joint Motions to Terminate the above-identified inter partes reviews are granted; FURTHER ORDERED that the above-identified proceedings are terminated as to all parties—namely, Intel and Zond; and” slip op. at 3

    None
    Patents in suitUS 7,808,184
  • PTAB · Sep 15, 2014 · IPR2014-00446 · APJ Joni Y Chang · IPR · Order

    The Board granted the joint motions and terminated the instituted proceedings as to Intel and Zond after settlement.

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

      “Generally, the Board expects that a proceeding will terminate after the filing of a settlement agreement. See, e.g., Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012). Upon consideration of the facts before us, we determine that it is appropriate to terminate the above-identified proceedings as to both parties, and enter judgment. For the foregoing reasons, it is: ORDERED that the Joint Motions to Terminate the above-identified inter partes reviews are granted; FURTHER ORDERED that the above-identified proceedings are terminated as to all parties—namely, Intel and Zond; and FURTHER ORDERED that the parties’ Joint Request that their Written Settlement Agreement be treated as business confidential information kept separate from the patent file, and made available only to Federal Government agencies on written request, or to any person on a showing of good cause, pursuant to 35 U.S.C. § 317(b) and 37 C.F.R. § 42.74(c), is granted.” slip op. at 3

    None
    Patents in suitUS 7,147,759
  • PTAB · Sep 15, 2014 · IPR2014-00444 · APJ Joni Y Chang · IPR · Order

    The Board granted the joint motions, terminated the instituted proceedings as to Intel and Zond, and granted confidential treatment of the settlement agreement.

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

      “Generally, the Board expects that a proceeding will terminate after the filing of a settlement agreement. See, e.g., Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012). Upon consideration of the facts before us, we determine that it is appropriate to terminate the above-identified proceedings as to both parties, and enter judgment. For the foregoing reasons, it is: ORDERED that the Joint Motions to Terminate the above-identified inter partes reviews are granted; FURTHER ORDERED that the above-identified proceedings are terminated as to all parties—namely, Intel and Zond; and FURTHER ORDERED that the parties’ Joint Request that their Written Settlement Agreement be treated as business confidential information kept separate from the patent file, and made available only to Federal Government agencies on written request, or to any person on a showing of good cause, pursuant to 35 U.S.C. § 317(b) and 37 C.F.R. § 42.74(c), is granted.” slip op. at 3

    None
    Patents in suitUS 7,147,759
  • PTAB · Sep 15, 2014 · IPR2014-00468 · APJ Joni Y Chang · IPR · Order

    The Board granted the joint motions, terminated the instituted inter partes reviews as to Intel and Zond, and granted confidential treatment of the settlement agreement.

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

      “Generally, the Board expects that a proceeding will terminate after the filing of a settlement agreement. See, e.g., Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012). Upon consideration of the facts before us, we determine that it is appropriate to terminate the above-identified proceedings as to both parties, and enter judgment. For the foregoing reasons, it is: ORDERED that the Joint Motions to Terminate the above-identified inter partes reviews are granted; FURTHER ORDERED that the above-identified proceedings are terminated as to all parties—namely, Intel and Zond; and” slip op. at 3

    None
    Patents in suitUS 7,811,421
  • PTAB · Sep 15, 2014 · IPR2014-00445 · APJ Joni Y Chang · IPR · Order

    The Board granted the joint motions, terminated the instituted proceedings as to Intel and Zond, and granted confidential treatment of the settlement agreement.

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

      “Generally, the Board expects that a proceeding will terminate after the filing of a settlement agreement. See, e.g., Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012). Upon consideration of the facts before us, we determine that it is appropriate to terminate the above-identified proceedings as to both parties, and enter judgment. For the foregoing reasons, it is: ORDERED that the Joint Motions to Terminate the above-identified inter partes reviews are granted; FURTHER ORDERED that the above-identified proceedings are terminated as to all parties—namely, Intel and Zond; and FURTHER ORDERED that the parties’ Joint Request that their Written Settlement Agreement be treated as business confidential information kept separate from the patent file, and made available only to Federal Government agencies on written request, or to any person on a showing of good cause, pursuant to 35 U.S.C. § 317(b) and 37 C.F.R. § 42.74(c), is granted.” slip op. at 3

    None
    Patents in suitUS 7,147,759
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