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  • PTAB · May 26, 2026 · IPR2025-00425 · APJ Kristina M Kalan · IPR · Remand

    The Board denied institution of IPR2025-00425 because it instituted the earlier-considered IPR2025-00424 challenging the same patent.

    RulingsRemand decision
    • RemandOther

      “Request for Director Review. See Paper 35; IPR2025-00424, Paper 35. The request was denied without prejudice and the cases were remanded to the Board to “allow discovery, narrowly tailored to resolve the RPI and privity issues.” Paper 41, 4. Following such discovery, we were instructed to “then determine on the full record whether Petitioners have met their burden of demonstrating that the Petitions are not time-barred under § 315(b), applying the framework set forth in Worlds Inc. v. Bungie, Inc., 903 F.3d 1237, 1242– 44 (Fed. Cir. 2018).” Id. A later-issued Order Supplementing Director Review Decision instructed that “if the Board determines that Petitioners met their burden to identify all RPIs in the Petitions, then the Board should maintain at most one IPR challenging” the ’225 patent. Paper 64, 3. Concurrently herewith, we issue a decision in IPR2025-00424 finding that Petitioner has met its burden of demonstrating that the Petition in that case is not time-barred under 35 U.S.C. § 315(b).” slip op. at 3

    • Other 314aInstitution denied discretionary otherInstitution denied

      “In connection with the ’225 patent, Petitioner filed two petitions requesting inter partes review: the petition in this proceeding (IPR2025- 00425), and the petition in IPR2025-00424. In this proceeding and in IPR2025-00424, Petitioner filed an Explanation regarding the necessity of multiple petitions. Paper 2; IPR2025-00424, Paper 2. Petitioner requested that, “if the Board uses its discretion to institute the Petitions, the Board consider the merits of IPR2025-00424 . . . before IPR2025-00425.” Paper 2,” slip op. at 2

    Discretionary denial
    Patents in suitUS 10,589,225
  • PTAB · Feb 10, 2026 · IPR2025-00688 · APJ Kristina M Kalan · IPR · Remand

    On remand, the Board denied institution of IPR on claims 1–18 because this was the second-ranked petition and the Director directed institution of only one petition.

    RulingsRemand decision
    • RemandDecided for patent owner

      “Remand, do not institute inter partes review based on the second-ranked petition on this complete record. As stated in the Remand, “Petitioners present ten total grounds challenging the claims of the ’370 patent and thirteen total grounds challenging the claims of the ’218 patent [in IPR2025- 00717 and IPR2025-00718].” Remand 3. The Remand cites to the Board’s Trial Practice Guide, which “explains that ‘one petition should be sufficient to challenge the claims of a patent in most situations’ and ‘multiple petitions by a petitioner are not necessary in the vast majority of cases.’” Id. (citing Patent Trial and Appeal Board Trial Practice Guide (“TPG”) § II.D.2 (Dec. 12, 2025)). The Remand states: “The TPG further explains that dispute requiring arguments under multiple prior art references.’ TPG § II.D.2.” Id. at 2–3. The Remand determines: “Given that Petitioners had ample room in each petition to present multiple grounds challenging the claims of each patent, this was not a ‘rare’ circumstance that justified the filing of multiple petitions against each patent.” Id. at 3. The Remand explains that “absent exceptional circumstances, in a case where there is a dispute over priority date, the Board should either resolve the priority date issue or institute, at most, the first-ranked petition.” Id. The Director instructed the Board panel “to determine which of the two petitions” to institute. Id. at 4. We interpret the Remand as stating that the Director has determined that only one petition for each patent should have been instituted, and as delegating the discretionary authority to the panel to determine which of the two petitions to institute. Accordingly, in view of the foregoing and in view of Petitioner’s ranking of this Petition as the second-ranked petition, we deny institution of inter partes review.” slip op. at 11

    • Parallel petitionsInstitution denied discretionary otherInstitution denied

      “Remand, do not institute inter partes review based on the second-ranked petition on this complete record. As stated in the Remand, “Petitioners present ten total grounds challenging the claims of the ’370 patent and thirteen total grounds challenging the claims of the ’218 patent [in IPR2025- 00717 and IPR2025-00718].” Remand 3. The Remand cites to the Board’s Trial Practice Guide, which “explains that ‘one petition should be sufficient to challenge the claims of a patent in most situations’ and ‘multiple petitions by a petitioner are not necessary in the vast majority of cases.’” Id. (citing Patent Trial and Appeal Board Trial Practice Guide (“TPG”) § II.D.2 (Dec. 12, 2025)). The Remand states: “The TPG further explains that dispute requiring arguments under multiple prior art references.’ TPG § II.D.2.” Id. at 2–3. The Remand determines: “Given that Petitioners had ample room in each petition to present multiple grounds challenging the claims of each patent, this was not a ‘rare’ circumstance that justified the filing of multiple petitions against each patent.” Id. at 3. The Remand explains that “absent exceptional circumstances, in a case where there is a dispute over priority date, the Board should either resolve the priority date issue or institute, at most, the first-ranked petition.” Id. The Director instructed the Board panel “to determine which of the two petitions” to institute. Id. at 4. We interpret the Remand as stating that the Director has determined that only one petition for each patent should have been instituted, and as delegating the discretionary authority to the panel to determine which of the two petitions to institute. Accordingly, in view of the foregoing and in view of Petitioner’s ranking of this Petition as the second-ranked petition, we deny institution of inter partes review.” slip op. at 11

    Discretionary denial
    Patents in suitUS 10,933,370
  • PTAB · Feb 10, 2026 · IPR2025-00718 · APJ Zhenyu Yang · IPR · Remand

    On remand, the Board denied institution of IPR on claims 1–4 and 6–26 because it instituted the higher-ranked competing petition, IPR2025-00717.

    RulingsRemand decision
    • Director reviewDirector review, grantedOther

      “The Director granted Director Review, finding that the panel “abused its discretion in granting institution of two petitions that each challenge the same claims” of the ’218 patent. Paper 38 (“Remand Order”), 2. The Director vacated the DI and remanded the case to the Board “to determine which of the two petitions” to institute. Id. at 4.” slip op. at 4

    • Parallel petitionsInstitution denied discretionary otherInstitution denied

      “In its Explanation regarding the necessity of multiple petitions, Petitioner requests that, “if the Board uses its discretion to institute the Petitions, the Board consider the merits of IPR2025-00[71]7 (“Vosteen589/Lissianski Petition”) before IPR2025-00[71]8 (“Sjostrom/Baldrey Petition”).” Paper 2, 3. Because we institute trial in IPR2025-00717 (see IPR2025-00717, Paper 41), under the Director’s instruction in the Remand Order, and based on Petitioner’s ranking of the petitions of IPR2025-00717 and IPR2025-00718, we deny institution in this case.” slip op. at 12

    Discretionary denial
    Patents in suitUS 10,926,218
  • PTAB · Feb 10, 2026 · IPR2025-00687 · APJ Kristina M Kalan · IPR · Remand

    On remand, the Board instituted IPR on claims 1–8 and 10–18 over all asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.

    RulingsRemand decision
    • RemandInstituted

      “Paper 34, 1 (requesting “Director Review of the Director’s August 22, 2025 Decision Referring the Petition to the Board (‘Referral Decision’)”). Patent Owner argued that institution of IPR2025-00687 and IPR2025-00688 “should be discretionarily denied.” Id. at 5. Petitioner opposed. Paper 37. The Director granted review and found that “granting institution of two petitions that each challenge the same claims of the ’370 patent and ’218 patent 2” was an “abuse[] of discretion.” Paper 40, 1. The Director remanded the cases “to the Board panel to determine which of the two petitions challenging each of the ’370 and ’218 patents to institute.” Id. at 3. Pursuant to the Director’s instruction that we choose only one of the two petitions challenging the ’370 patent to institute, and for the reasons set forth below, we choose to institute review of the ’370 patent in this Petition, and not in IPR2025-00688.” slip op. at 3

    • PTAB / AIA Trials › §315(b) time barNot time barredDecided for petitioner

      “the proceeding is filed more than 1 year after the date on which the petitioner, real party in interest, or privy of the petitioner is served with a complaint alleging infringement of the patent.” 35 U.S.C. § 315(b). Petitioner bears the burden of demonstrating compliance with 35 U.S.C. § 312(a)(2) and § 315(b). See, e.g., Ventex Co., Ltd. v. Columbia Sportswear N. Am., Inc., IPR2017-00651, Paper 152 (PTAB Jan. 24, 2019)” slip op. at 9

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC, Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995). Furthermore, the prior art itself can reflect the appropriate level of ordinary skill in the art. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 13

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

      “Petitioner “[does] not, at this time, contend that any term requires construction,” and instead, states that “[a]ll terms have been accorded their plain and ordinary meaning.” Pet. 11 (citing Ex. 1002 ¶¶ 212–215). Patent Owner asserts that it “does not presently propose any constructions,” but discusses the Board’s claim construction in IPR2020- 00834, Paper 18, 7–8. Prelim. Resp. 7. Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to construe any claim term expressly.” slip op. at 14

    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR
    Patents in suitUS 10,933,370
  • PTAB · Feb 10, 2026 · IPR2025-00717 · APJ Zhenyu Yang · IPR · Remand

    On remand, the Board instituted IPR of claims 1–4 and 6–26 on all six asserted obviousness grounds, finding a reasonable likelihood of prevailing.

    RulingsRemand decision
    • Director reviewDirector review, grantedOther

      “The Director granted Director Review, finding that the panel “abused its discretion in granting institution of two petitions that each challenge the same claims” of the ’218 patent. Paper 39, 2. The Director vacated the DI and remanded the case “to the Board panel to determine which of the two petitions” to institute. Id. at 4.” slip op. at 4

    • Parallel petitionsDecided for petitioner

      “On November 4, 2025, we instituted inter partes review of all challenged claims based on all the grounds raised in the Petition. Paper 35 (“DI”). In the DI, we noted that “Petitioner filed an explanation regarding the necessity of multiple petitions,” and “Patent Owner d[id] not challenge that multiple petitions are necessary” in the Preliminary Response. Paper 23, 3 n.3.” slip op. at 3

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

      “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.” 35 U.S.C. § 314(a). For the reasons provided below, we determine Petitioner has satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Therefore, we institute inter partes review of all challenged claims based on all the grounds raised in this Petition.3” slip op. at 4

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner asserts that “[a] person of ordinary skill in the art [“POSITA”] would have at least a bachelor’s degree in chemical engineering, mechanical engineering, or a related field of study with at least two years of experience implementing pollution control in power generation plants for natural gas, coal, and/or industrial waste incineration.” Pet. 11 (citing Ex. 1002 ¶¶ 48–51). Patent Owner does not dispute the level of ordinary skill in the art. See generally Prelim Resp. For purposes of this Decision, we adopt Petitioner’s proposed definition of a POSITA because it is consistent with the skill level reflected in the disclosures of the ’218 patent and prior art. See Okajima, 261 F.3d at 1355 (the prior art may reflect an appropriate level of skill in the art).” slip op. at 10

    Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR
    Patents in suitUS 10,926,218
  • PTAB · Aug 30, 2024 · IPR2022-01531 · APJ Devon Zastrow Newman · IPR · Remand

    On remand, the Board instituted inter partes review of claims 1–17, 20–21, 24–26, and 29–34 on all grounds stated in the Petition.

    RulingsRemand decision
    • Director reviewOther

      “Petition did not establish a reasonable likelihood that Petitioner would prevail with respect to at least one of the challenged claims, and did not institute inter partes review. Paper 17 (“Inst. Dec.”). Petitioner requested Director review of our decision denying institution (Paper 18 (“Request”)). The Director delegated review of the decision to a Delegated Rehearing Panel. Paper 19. Patent Owner was granted the option to file a response to Petitioner’s Request (Paper 22 (“Request Resp.”)). The Director Review Panel (“DRP”) vacated our decision and remanded the case to this panel with a revised construction for claim 1. Paper 23 (“DRP Dec.”).” slip op. at 2

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

      “An inter partes review may be instituted only if “the information presented in the petition . . . and any [preliminary] response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect (2018). Upon reconsideration of the briefing and the evidence of record in light of the DRP’s claim construction, we conclude that Petitioner has established a reasonable likelihood of prevailing on its assertion that at least one of the challenged claims is unpatentable. Accordingly, we grant institution of inter partes review of claims 1–17, 20–21, 24–26, and 29–34 of the ’682 patent.” slip op. at 2

    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied

      “We find that Petitioner has demonstrated a material error by the Office in the prior consideration of Morales-Sanfrutos, Straus, Singh, and Lees. For instance, under the second prong of Advanced Bionics, we consider “(c) the extent to which the asserted art was evaluated during “(e) whether Petitioner has pointed out sufficiently how the Examiner erred in its evaluation of the asserted prior art.” Becton, Dickinson, 17–18. We agree with Petitioner that the Office overlooked Morales- Sanfrutos’ and Singh’s teachings during examination and reexamination. Pet. 79. Although Morales-Sanfrutos, Straus, and Singh were listed on an IDS, they were not the subject of a rejection during examination or reexamination. Moreover, for the reasons discussed below at this stage with regard to Petitioner’s grounds over Morales-Sanfrutos, as evidenced by Straus, and over Singh, Petitioner sufficiently demonstrates that the Office materially erred in overlooking Morales-Sanfrutos’s and Singh’s teachings regarding their linker structures. Id. Further, to the extent the Lees’ teachings were considered during examination and reexamination, Lees’ disclosure of a homobifunctional sulfone linker was overlooked. Lees’ homobifunctional linker, which Patent Owner argues is substantially similar to Harris’ homobifunctional linker, which Petitioner chiefly relies upon in Grounds 2–5, was not the subject of a rejection during examination. Pet. Resp. Brief 1; Prelim. Resp. 25–26. We agree with Petitioner that only Lees’ heterobifunctional linker was applied in a rejection during examination. Pet. Resp. Brief 1; Ex. 1018, 42–43, 62. 4. Conclusion For the foregoing reasons, we decline to exercise discretion to deny institution under § 325(d).” slip op. at 27

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Based on the information presented, we find that the asserted prior art itself is sufficient to demonstrate the level of skill in the art at the time of 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 apply Petitioner’s unopposed definition for purposes of determining whether to institute review because it is consistent with the disclosures of the asserted prior art references.” slip op. at 15

    Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
    Patents in suitUS 10,131,682
  • 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 · Sep 17, 2014 · IPR2014-00315 · APJ Lora M Green · IPR · Order

    The Board granted the parties’ joint motion and terminated the proceeding after settlement; the petitioner withdrew its rehearing request.

    RulingsOther
    • RehearingOther

      “We note that we denied institution of inter partes review on July 8, 2014. Paper 14. Petitioner, however, filed a Request for Rehearing Pursuant to 37 C.F.R. § 42.71 of our decision not to institute trial, and that Request has not yet been decided. Thus, the possibility that trial may be instituted still remains. Petitioner also withdraws its Request for Rehearing in view of the joint motion to terminate. Based on the facts of this case, it is appropriate to enter judgment.2 Therefore, the joint motion to terminate the proceeding is GRANTED.” slip op. at 2

    None
    Patents in suitUS 8,318,738

Holdings, summaries, rulings, issues, outcomes, winners and claim constructions shown for a decision were generated by a large language model reading the opinion. They are a guide to the decision, not the decision. Confirm every one against the court's own text before relying on it. Outcomes read from the patent owner’s side. Party names are extracted from the decision and are missing on about 900 short Director denials and scans, which carry the trial number instead.