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  • PTAB · Mar 31, 2020 · IPR2018-01711 · APJ James A Worth · IPR · Final written decision

    The Board held claims 1–18 of the ’907 patent not unpatentable over Olesen, Tan, and Queen under §103, finding Lilly had not met its burden.

    RulingsFinal written decision
    • Skill levelSkill level board ownOther

      “appreciable difference in the parties’ respective definitions of a person of ordinary skill in the art. Inst. Dec. 8. Accordingly, we determined for purposes of our Institution Decision that a person of ordinary skill in the art” slip op. at 13

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

      “2. “effective amount” The term “effective amount” is recited in all of the independent” slip op. at 18

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable

      “Reply. In fact, Petitioner argues that “[t]he prior art expressly recognized the downside of treating migraine patients with CGRP inhibitors having a short half-life,” citing to a report that CGRP8-37 (a peptide fragment of CGRP) “‘proved ineffective in migraine treatment’ due to ‘its low potency and short half-life.’” Pet. 31 (citing Ex. 1031, 323; Ex. 1014 ¶ 124) (emphasis by Petitioner). Accordingly, we find that Petitioner has not sufficiently established that a POSA would have been motivated to humanize an anti-CGRP antibody fragment.” slip op. at 93

    • ExcludeMotion to exclude, grantedMotion to exclude, deniedGranted in part

      “the cross-examination of Dr. Ferrari as beyond the scope of Dr. Ferrari’s direct testimony. Mot. Excl. 9. Upon review of the Ferrari Declaration, Exhibit 2268, we agree that questions on cyclic AMP were beyond the scope of the Ferrari Declaration. Accordingly, we grant this aspect of the motion.” slip op. at 159

    Patent outcomesUS 9,884,907 not shown unpatentable
    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 9,884,907
  • PTAB · Mar 31, 2020 · IPR2018-01710 · APJ Richard J Smith · IPR · Final written decision

    The Board found that Lilly did not prove claims 1, 3, 4, 8–17, 19, 20, and 24–31 of the ’045 patent, or claims 1–18 of the ’907 and ’908 patents, unpatentable over Olesen, Tan, and …

    RulingsFinal written decision
    • Skill levelSkill level board ownDecided for patent owner

      “appreciable difference in the parties’ respective definitions of a person of ordinary skill in the art. Inst. Dec. 8. Accordingly, we determined for purposes of our Institution Decision that a person of ordinary skill in the art” slip op. at 13

    • ExcludeMotion to exclude, grantedMotion to exclude, deniedGranted in part

      “conclusion based on underlying factual findings. Nobel Biocare Servs. AG v. Instradent USA, Inc., 903 F.3d 1365, 1375 (Fed. Cir. 2018) (citing Jazz Pharm., Inc. v. Amneal Pharm., LLC, 895 F.3d 1347, 1356 (Fed. Cir. 2018)). The underlying factual findings include whether the reference was publicly accessible. Id. (citing In re NTP, Inc., 654 F.3d 1279, 1296 (Fed. Cir. 2011)). In an inter partes review, the petitioner bears the burden of establishing by a preponderance of the evidence that a particular document is a printed publication. Id. (citing Medtronic Inc. v. Barry, 891 F.3d 1368, 1380 (Fed. Cir. 2018)); see also In re Wyer, 655 F.2d 221, 227 (CCPA 1981) (a party asserting a reference as a prior art printed publication should provide sufficient proof of accessibility).” slip op. at 152

    • Strike new argumentNew argument consideredDenied

      “(Ex. 2239), and also the opportunity to submit a Sur-reply (Paper 43). Therefore, we determine that Patent Owner has failed to meet its burden to show that the arguments and evidence should be stricken. See 37 C.F.R. § 42.20; Genzyme Therapeutic Prods. L.P. v. Biomarin Pharm Inc., 825 F.3d 1360, 1367 (Fed. Cir. 2016); see also Anacor Pharms., Inc. v. Iancu, 889 F.3d 1372, 1380–81 (Fed. Cir. 2018) (reply may document the knowledge that skilled artisans would bring to bear in reading the prior art identified as producing obviousness). Accordingly, this aspect of the motion is denied.” slip op. at 163

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundReasonable expectation not foundNot shown unpatentable

      “Reply. In fact, Petitioner argues that “[t]he prior art expressly recognized the downside of treating migraine patients with CGRP inhibitors having a short half-life,” citing to a report that CGRP8-37 (a peptide fragment of CGRP) “‘proved ineffective in migraine treatment’ due to ‘its low potency and short half-life.’” Pet. 31 (citing Ex. 1031, 323; Ex. 1014 ¶ 124) (emphasis by Petitioner). Accordingly, we find that Petitioner has not sufficiently established that a POSA would have been motivated to humanize an anti-CGRP antibody fragment.” slip op. at 93

    Patent outcomesUS 8,586,045 not shown unpatentable
    § 103 obviousnesscites KSR · Graham
    Patents in suitUS 8,586,045
  • PTAB · Mar 31, 2020 · IPR2018-01712 · APJ James A Worth · IPR · Final written decision

    The Board held claims 1–18 of the ’908 patent not unpatentable because Lilly failed to prove the Olesen, Tan, and Queen obviousness ground by a preponderance of the evidence.

    RulingsFinal written decision
    • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable

      “Reply. In fact, Petitioner argues that “[t]he prior art expressly recognized the downside of treating migraine patients with CGRP inhibitors having a short half-life,” citing to a report that CGRP8-37 (a peptide fragment of CGRP) “‘proved ineffective in migraine treatment’ due to ‘its low potency and short half-life.’” Pet. 31 (citing Ex. 1031, 323; Ex. 1014 ¶ 124) (emphasis by Petitioner). Accordingly, we find that Petitioner has not sufficiently established that a POSA would have been motivated to humanize an anti-CGRP antibody fragment.” slip op. at 93

    • ExcludeMotion to exclude, grantedMotion to exclude, deniedGranted in part

      “form, not relevant, vague, mischaracterized the witnesses’ prior testimony, called for a legal conclusion, lacked clarity, or contained compound questions. Mot. Excl. 7–12. We consider Patent Owner’s arguments in this regard to address issues of weight rather than admissibility, and we deny these aspects of the motion. See Corning Inc. v. DSM IP Assets B.V., IPR2013-00053, Paper 66 at 19 (PTAB May 1, 2014) (sitting as a non-jury tribunal, the Board may assign appropriate weight to evidence presented) (citing Donnelly Garment Co. v. NLRB, 123 F.2d 215, 224 (8th Cir. 1941)).” slip op. at 158

    • Strike new argumentNew argument consideredDenied

      “(Ex. 2239), and also the opportunity to submit a Sur-reply (Paper 43). Therefore, we determine that Patent Owner has failed to meet its burden to show that the arguments and evidence should be stricken. See 37 C.F.R. § 42.20; Genzyme Therapeutic Prods. L.P. v. Biomarin Pharm Inc., 825 F.3d 1360, 1367 (Fed. Cir. 2016); see also Anacor Pharms., Inc. v. Iancu, 889 F.3d 1372, 1380–81 (Fed. Cir. 2018) (reply may document the knowledge that skilled artisans would bring to bear in reading the prior art identified as producing obviousness). Accordingly, this aspect of the motion is denied.” slip op. at 163

    Patent outcomesUS 9,884,908 not shown unpatentable
    § 103 obviousnesscites KSR · Graham
    Patents in suitUS 9,884,908

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