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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 · 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 · Jan 10, 2018 · IPR2016-01404 · APJ Kamran Jivani · IPR · Final written decision

    The Board found claims 1, 2, 13, 14, 33, 34, 39, 46, and 48 not shown unpatentable: Bensimon did not disclose the claimed restricted-access mode, and Takahashi did not cure that deficiency.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “B. Level of Ordinary Skill in the Art Petitioner states––and Patent Owner does not dispute––that “a person having ordinary skill in the art of secure computer data storage devices (i.e. in the art for the ’459 patent) would have had (i) a B.S. degree in electrical engineering, computer engineering, computer science, or equivalent training, and (ii) approximately two years of experience in the design or research of secure computer data storage devices.” Pet. 4 (citing Ex. 1002 ¶ 32). We agree with Petitioner’s statement of the level skill of an ordinary artisan at the time and adopt it as our own. Although Patent Owner does not directly address an ordinary artisan’s level of skill, Petitioner’s description of the level of skill accords with that of Patent Owner’s witness Dr. Goldschlag. Compare id., with Ex. 2004 ¶ 21 (opining that “one of ordinary skill in the art would have had a Bachelor’s degree in Computer Science, Computer Engineering, Electrical Engineering, or equivalent training, as well as two to three years of technical experience in the field of computer security and storage devices.”). We further find the level of ordinary skill in the art is reflected by the prior art of record. See Okajima v. Bourdeau,” slip op. at 8

    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner

      “within an electronic circuit embedded within the storage device.” Ex. 1001, 9:58–59, 10:34–35. Although these claims are not at issue in this case, they evince the patentee’s desire to employ each of the terms “unique” and “specific” where each is intended. It is well established that ordinarily different claim terms are presumed to have different meanings. Applied Med. Res. Corp. v. U.S. Surgical Corp., 448 F.3d 1324, 1333 n.3 (Fed. Cir. 2006) (“[T]he use of two terms in a claim requires that they connote different meanings. . . .”); CAE Screenplates Inc. v. Heinrich Fiedler GmbH, 224 F.3d 1308, 1317 (Fed. Cir. 2000) (“In the absence of evidence to the contrary, we must presume that the use of these different terms in the claims connotes different meanings.”). Further, the Specification describes that, depending on the selected security level, a cryptographic key can be generated using in part “device-specific security information derived from the unique format information of the removable storage device.” Ex. 1001, 3:66–4:1. The Specification thus describes the format information of the removable storage device as “unique” but describes the security information of the device merely as “specific,” not “unique.” Finally, the Specification discloses “for exemplary purposes only” an embodiment wherein “a unique, device-specific security information can be generated from the unique characteristics of the underlying storage medium.” Id. at 7:43–47 (emphasis added). The Specification thus describes device-specific security information as unique in a particular, non-limiting example and explicitly indicates that the device-specific security information derived in that example is “unique.” See id. In light of the foregoing description, we disagree with Patent Owner’s arguments that “specific” in the context of the claim term “device-specific security information” means unique. Construing “specific” to mean “unique” as Patent Owner urges would render meaningless the subsequent use of “unique” in claims 9 and 17, without a clear indication in the Specification of such an intent. See In re Paulsen, 30 F.3d at 1480. Instead, we accord the word “specific” its ordinary and customary meaning and construe “device-specific security information” as meaning “information particular to, but not necessarily unique to, a storage device and used to secure access to the storage device.” Although we construe the disputed term “device-specific security information,” our determination that Petitioner has failed to show by a preponderance of the evidence that any of the Instituted Claims are unpatentable is not dependent upon our construction, as detailed below.” slip op. at 10

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable

      “Petitioner has not identified in Bensimon explicit or inherent disclosure of the claimed restricted-access mode. Claim 1 requires operating in restrictedaccess mode “when the storage device does not have the device-specific security information.” Ex. 1001, 9:24–26. Petitioner identifies Bensimon’s read/write password, either alone or in combination with the password-enabling flag, as meeting the claimed device-specific security information. Reply 13; Pet. 22. Thus, in order to meet the requirements of claim 1, Petitioner is required to show that Bensimon discloses operating in restricted-access mode when the storage device does not have the read/write password, or alternatively does not have the combination of the read/write password and password-enabling flag. See, e.g., In re Bond, 910 F.2d at 832 (Fed. Cir. 1990) (holding that in order to show anticipation, claimed elements must be arranged as required by the claim). Petitioner does not make the required showing. As Petitioner argues: “these claims recite operating in one mode if ‘the device-specific security information’ (i.e., that instance of device-specific security information) is present, and operating in another mode if ‘the device-specific security information’ (i.e., that instance of device-specific security information) is not present.” Reply 16. Petitioner identifies Bensimon’s read/write password, alone or in combination with the password-enabling flag, as the device-specific security information, yet Petitioner does not identify in Bensimon an explicit disclosure that Bensimon’s storage device operates in the claimed restricted-access mode when the read/write password is absent from the device. See id. at 16–22. Rather, Bensimon describes two different possible modes of operation when the read/write password is absent from the storage device, namely either no protection or write protection. Ex. 1004, 5:33–39, 6:3–4, 6:13–29. Contrary to the claim language, operation in Bensimon’s write protection mode depends upon the presence of the write protection password, not upon the absence of the read/write password and password-enabling flag (i.e. the claimed device-specific security information). Ex. 1004, 6:13–23; see also Reply 16 (citing Ex. 1012 ¶ 18) (asserting the claimed restricted-access mode is met “when Bensimon’s storage device 100 only has the write-protection (read-only) password”). This disclosure is insufficient to establish anticipation because claim 1 requires operating in restricted access mode when the storage device does not have the device-specific storage information, which Petitioner asserts is the read/write password and password-enabling flag. “A claim is anticipated only if each and every element as set forth in the claims is found.” Verdegaal Bros., Inc. v. Union Oil. Co. of Cal., 814 F.2d 628, 631 (Fed. Cir. 1987). We similarly are not persuaded that Bensimon inherently anticipates claim 1. “Under the principles of inherency, if the prior art necessarily functions in accordance with, or includes, the claimed limitations, it anticipates.” In re Cruciferous Sprout Litig., 301 F.3d 1343, 1349 (Fed. Cir. 2002) (citations and internal quotation marks omitted). Here, the cited disclosure identifies two possible modes of operation when the read/write password and password-enabling flag are absent from Bensimon’s storage device, neither of which necessarily must occur.” slip op. at 16

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableNot shown unpatentable

      “E. Obviousness of Claims 2 and 34 based on Bensimon in combination with Takahashi Petitioner asserts dependent claims 2 and 34 would have been obvious in light of Bensimon and Takahashi. Pet. 36–40 (analysis of claim 2) and 42–43 (analysis of claim 34). Petitioner’s analysis of these claims does not repair the deficiencies described above with regard to the claimed restrictedaccess mode. See id.; see also Reply 25. Accordingly, for the reasons discussed above in the context of claim 1 and based on the full trial record, we determine that Petitioner has failed to show by a preponderance of the evidence that claims 2 and 34 would have been obvious in light of Bensimon and Takahashi. See supra Section III.D.2.” slip op. at 18

    Claim construction§ 102 anticipation§ 103 obviousnesscites Graham
    Patents in suitUS 6,968,459
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