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  • 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 · Jul 31, 2024 · IPR2023-00682 · APJ Thu A Dang · IPR · Remand

    The Board denied institution under § 325(d), finding substantially the same art had been presented to the Office and no material Office error was shown.

    RulingsRemand decision
    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied

      “In light of these similarities, we find that the Petition relies on art that is substantially the same as art previously evaluated by the Office. 3. Advanced Bionics Part II: Office Error Because the first part of the Advanced Bionics framework is satisfied, we next determine whether Petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, Paper 6 at 8.” slip op. at 32

    • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Not reached

      “7 Because we deny the Petition under 35 U.S.C. § 325(d), we do not reach Patent Owner’s request that we deny the Petition under Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 at 13–14 (PTAB Mar. 20, 2020) (precedential). See Prelim. Resp. 53–60. Nor do we reach the parties’ merits arguments.” slip op. at 34

    Discretionary denial
    Patents in suitUS 10,771,181
  • PTAB · Jul 31, 2024 · IPR2023-00681 · APJ Thu A Dang · IPR · Remand

    On remand, the Board denied institution under § 325(d), finding substantially the same art had been presented to the Office and no material Office error was shown.

    RulingsRemand decision
    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied

      “(1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims.” slip op. at 18

    • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Not reached

      “III. CONCLUSION For the foregoing reasons, we exercise discretion under 35 U.S.C. § 325(d) to deny institution of an inter partes review.7 IV. ORDER In consideration of the foregoing, it is ORDERED that the Petition is denied, and no trial is instituted. 7 Because we deny the Petition under 35 U.S.C. § 325(d), we do not reach Patent Owner’s request that we deny the Petition under Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 at 13–14 (PTAB Mar. 20, 2020) (precedential). See Prelim. Resp. 53–60. Nor do we reach the parties’ merits arguments.” slip op. at 35

    Discretionary denial
    Patents in suitUS 10,263,723
  • PTAB · Jul 31, 2024 · IPR2023-00680 · APJ Thu A Dang · IPR · Remand

    On remand, the Board denied institution for all challenged claims under § 325(d), finding substantially the same art and arguments had been presented and no material Office error shown.

    RulingsRemand decision
    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied

      “1. Framework In evaluating the exercise of discretion to deny institution under Section 325(d), the Board uses the following two-part framework: (1) determining whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of the first part of the framework is satisfied, determining whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, LLC v. Med-El Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential) (“Advanced Bionics”). Within this two-part framework, the Board considers a number of non-exclusive factors in evaluating whether to exercise its discretion under § 325(d). See Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8 (PTAB Dec. 15, 2017) (precedential as to § III.C.5, first para.) (“Becton, Dickinson”); see also Advanced Bionics at 9–11. The factors set forth in Becton, Dickinson are as follows: (a) the similarities and material differences between the asserted art and the prior art involved during examination; (b) the cumulative nature of the asserted art and the prior art evaluated during examination; (c) the extent to which the asserted art was evaluated during examination, including whether the prior art was the basis for rejection; (d) the extent of the overlap between the arguments made during examination and the manner in which petitioner relies on the prior art or patent owner distinguishes the prior art; (e) whether petitioner has pointed out sufficiently how the Examiner erred in its evaluation of the asserted prior art; and (f) the extent to which additional evidence and facts presented in the petition warrant reconsideration of the prior art or arguments. Becton, Dickinson, Paper 8 at 17–18. Becton, Dickinson factors (a), (b), and (d) relate to whether the art or arguments presented in the Petition are the same or substantially the same as those previously presented to the Office. Advanced Bionics, Paper 6 at 10. The art or arguments presented in the Petition are not “substantially the same” as those previously presented to the Office when there are differences between them that are material to the Office’s prior consideration of the art and arguments. Wolfspeed, Inc. v. Trs. of Purdue Univ., IPR2022-00761, Paper 13 at 7–8 (Vidal Mar. 30, 2023) (“Wolfspeed”). Factors (c), (e), and (f) “relate to whether the petitioner has” slip op. at 19

    • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Not reached

      “4 Because we deny the Petition under 35 U.S.C. § 325(d), we do not reach Patent Owner’s request that we deny the Petition under Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 at 13–14 (PTAB Mar. 20, 2020) (precedential). See Prelim. Resp. 52–59; Sur-reply 1–5. Nor do we reach the parties’ merits arguments.” slip op. at 37

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

      “III. CONCLUSION After considering the evidence and arguments presented in the Petition and Preliminary Response, we determine that, for each of Petitioner’s challenges, it is appropriate to exercise our discretion under 35 U.S.C. § 325(d) to deny the Petition with respect to those grounds. We accordingly exercise that discretion for the Petition as a whole and deny institution of an inter partes review.4 IV. ORDER In consideration of the foregoing, it is hereby: ORDERED that the Petition is denied, and no trial is instituted.” slip op. at 36

    Discretionary denial
    Patents in suitUS 9,887,795
  • PTAB · Oct 31, 2023 · PGR2022-00040 · APJ Cynthia M Hardman · PGR · Final written decision

    The Board cancelled claims 1–17 and denied substitute claims 18–30 for lack of written-description support; it did not reach the remaining grounds against the substitute claims.

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

      “For the reasons discussed below, on the full trial record, we find that Patent Owner has not carried its burden of showing by a preponderance of the evidence that the proposed substitute claims introduce no new matter relative to the original disclosure. 35 U.S.C. § 326(d)(3); 37 C.F.R. § 42.221(d)(1); see also Paper 58, 2 (Patent Owner acknowledging that it “bears the burden to meet the regulatory and statutory requirements” for a motion to amend, including demonstrating that the substitute claims do not “introduce new matter”). Importantly, we note that Patent Owner fails to explain how the material cited in the claim chart supports the claims. See Mot. 15–16. Instead, Patent Owner provides only a claim chart with bare citations, leaving it to the panel to discern how the cited material supports the claim limitations. See id. Patent Owner’s failure to explain the citations constitutes a fatal error, as we have reviewed the passages cited by Patent Owner and are unable to discern where support is found for several of the substitute claim limitations. Where, as here, “the Board is unable to determine how the specification and drawings support the proposed substitute claims, the motion to amend may be denied.” Patent Trial and Appeal Board Consolidated Trial Practice Guide (Nov. 2019) (“TPG”),6 71.” slip op. at 15

    • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable

      “Petitioner persuades us that the ’418 Application lacks adequate written description support for the formulation limitations of proposed substitute claim 18 [limitations 18a–8c]. As outlined by Petitioner and its declarants, the ’418 Application, including the Abstract, Field of the Invention, Summary of the Invention, and Detailed Description of the Invention sections, uniformly focuses on phosphate prodrugs of levodopa and carbidopa. See, e.g., Ex. 1004 (Sloan Decl.) ¶¶ 38–55, 64–69; Ex. 1003 (LeWitt Decl.) ¶¶ 89–97; Ex. 1047 (Forrest Decl.) ¶¶ 40–74, 80–92; Opp. 6– 10; Pet. 23–26, 49–55. We agree with Petitioner that “nothing in the specification suggests that the invention includes methods of subcutaneous infusion with anything other than the carbidopa prodrugs and L-dopa prodrugs of Formulas (I) and (II), respectively, or teaches how to get sufficient amounts of either L-dopa or carbidopa into solution, or achieve particular L-dopa plasma levels, without those particular prodrugs.” Pet. 27. Petitioner persuades us that the ’418 Application fails to contain “[so] much as a single generic sentence, anywhere in the application, suggesting the inventors possessed the claimed formulations.” Sur-reply 3. Additionally, the ’418 Application contains no example teaching administration of an aqueous formulation comprising carbidopa itself with levodopa itself or one of the three claimed levodopa prodrugs, let alone one that is suitable for continuous subcutaneous administration. See Ex. 1047 (Forrest Decl.) ¶¶ 61–72, 82–92. Patent Owner is correct that to establish written description support, neither “an actual reduction to practice,” nor a verbatim recitation of the claims is required. Sur-reply 4. Nevertheless, “[a]lthough examples are not always required to satisfy the written description requirement, the lack of any disclosure of examples may be considered when determining whether the claimed invention is adequately described.” Bos. Sci. Corp. v. Johnson & Johnson, 647 F.3d 1353, 1364 (Fed. Cir. 2011). Here, the lack of an actual reduction to practice or verbatim description of a formulation that falls within the scope of the claims is relevant, because we also see no other description or material in the ’418 Application that suggests the claimed methods extend to continuous subcutaneous administration of a composition comprising levodopa or one of the three claimed levodopa prodrugs, together with carbidopa, in an aqueous carrier.” slip op. at 28

    • ExcludeMotion to exclude, deniedDenied

      “All of the exhibits that are the subject of Patent Owner’s motion to exclude relate to the prior-art status and/or authenticity of Yacoby-Zeevi and ancillary related documents underlying Petitioner’s prior art-based challenges to the proposed substitute claims. See generally MTE. Because we deny Patent Owner’s request to enter proposed substitute claims 18–30 based on lack of written description support and do not reach Petitioner’s prior-art based challenges to the patentability of these claims, we do not rely on Exhibits 1005, 1007, 1040–1044, 1046, or 1048–1050 in this Decision. Accordingly we dismiss Patent Owner’s Motion to Exclude as moot.” slip op. at 49

    • Strike new argumentNew argument consideredDenied

      “On the other hand, Petitioner shows that Patent Owner took positions in its Motion to Amend that it only later sought to support with technical declarations. For example, in the Motion to Amend, Patent Owner elected to assert “that levodopa and carbidopa could be ‘interchanged’ in a formulation with their prodrugs, and that a skilled artisan could ‘perform a pharmacokinetic analysis to predict steady state levodopa plasma levels’ using the ‘parent compounds’ based on Example 24.” MTS 2 (citing Mot. 12–13). Patent Owner, however, “chose to forgo any expert support” on these issues at the time it filed its Motion to Amend, and instead waited until the Reply to submit technical declarations in support of these arguments. Id. We agree with Petitioner that although Patent Owner “was not required to anticipate the arguments that [Petitioner] would make in its Opposition” to the Motion to Amend, if Patent Owner “wanted to provide expert testimony to support the positions it actually took” in that Motion, “the TPG required [Patent Owner] to do so at that time, instead of waiting until [Petitioner] had limited ability to respond.” Id. at 5. Accordingly, we agree with Petitioner that in this respect at least some portions of Patent Owner’s Declarations are untimely, because it is “improper for a reply to present new evidence (including new expert testimony) that could have been presented in a prior filing.” TPG 74. Nevertheless, an order striking arguments and evidence in their entirety is an “exceptional remedy,” particularly under the circumstances here, where some portions of the Declarations are proper, while other portions are untimely. TPG 80. Moreover, “there is a strong public policy for making all information filed in an administrative proceeding available to the public.” Liberty Mut. Ins. Co. v. Progressive Cas. Ins. Co., CBM2012- 00010, Paper 59 at 40 (PTAB Feb. 24, 2014). Under the facts of this case, Patent Owner was permitted to file evidence to respond to Petitioner’s unpatentability claims, but also belatedly supported positions it made in earlier attorney argument. Petitioner’s Motion to Strike, however, challenges all of Patent Owner’s evidence, without acknowledging that some portions constitute proper reply. Although “[t]he Board is not required to attempt to sort proper from improper portions of the reply” (TPG 74, emphasis added), under the circumstances here, we agree with Patent Owner that Petitioner’s lack of specificity as to what it seeks to strike is fatal to Petitioner’s motion. Accordingly, we decline to strike the Declarations in their entirety as untimely.” slip op. at 46

    § 112 disclosure
    Patents in suitUS 11,091,507
  • PTAB · Feb 22, 2023 · IPR2019-01200 · APJ Lynne E Pettigrew · IPR · Remand

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

    RulingsRemand decision
    • RemandGranted

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

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

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

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

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

    RulingsRemand decision
    • RemandGranted

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

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

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

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

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

    RulingsRemand decision
    • RemandGranted

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

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

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

    None
    Patents in suitUS 7,247,552

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