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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 · Jun 26, 2025 · IPR2024-00294 · APJ David Cotta · IPR · Final written decision

    Claims 1–20 are unpatentable; proposed substitute claims 21–24 are also unpatentable, so the contingent motion to amend is denied.

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

      “appear to be that Patent Owner specifies that the POSA’s knowledge and experience may include optical sensors and that the POSA may have a degree emphasizing software. We do not deem these differences material, particularly because the optical sensors and technologies at issue are those used in physiological monitoring technologies and both parties agree that the POSA would have a working knowledge of physiological monitoring technologies. Ex. 1003 ¶ 24; PO Resp. 11. We find the additional specificity of Patent Owner’s definition to be helpful. In addition, Patent Owner’s definition appears to be consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’507 patent. Accordingly, we adopt Patent Owner’s proposed definition of the person of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“[T]he prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art. (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). We note that we would reach the same outcome under either definition of the POSA. Cf., PO Resp. 12 (asserting that Petitioner’s proposed definition is “flawed” but also asserting that “patentability is confirmed” “[r]egardless of the level of skill”).” slip op. at 14

    • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

      “Ex. 1007, 1528. The dispute between the parties focuses on whether D’Angelo was made available to attendees of the IEEE EMBS conference identified in this header and, if so, what effect that has.16 Accordingly, we begin our analysis by considering the conference.” slip op. at 42

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable

      “understood Mendelson to disclose averaging signals. We do not find in Mendelson any discussion of summing or averaging signals. See generally Ex. 1011, 912–915. Our inability to find a teaching of averaging in Mendelson is consistent with the testimony of Drs. Kenny and Duckworth. Dr. Kenny testifies that “there is simply no disclosure in Mendelson itself of any summing or averaging of collected signals.” Ex. 1083 ¶ 23. And in his deposition, Dr. Duckworth was unable to identify any express disclosure of averaging in Mendelson. See Ex. 1087, 103:9–114:11 (confirming that certain aspects of his declaration testimony relating to averaging of signals are not discussed in Mendelson). Accordingly, Mendelson, standing alone, does not support that the POSA would have understood Mendelson’s Sensor Module to have output averaged signals” slip op. at 28

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

      “the PDA to read out ‘data that’s been stored’ (i.e., previously measured physiological data) even after the Receiver Module’s battery had died” because Mendelson’s Receiver Module lacks “a microSD card or other nonvolatile storage from which measured data could be ‘read out’ after its battery has died.” PO Resp. 37; see also Ex. 2037 ¶ 147 (testimony of Dr. Duckworth confirming that Mendelson’s system could not store data that could be read out after its battery died). Accordingly, Patent Owner argues the POSA “would not have been motivated to modify Mendelson’s Receiver Module to draw power from the PDA as proposed because doing so would not allow the PDA to ‘read out’ the previously ‘measured physiological data’ after the Receiver Module’s battery died.” PO Resp. 39.” slip op. at 60

    § 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 10,736,507
  • 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 · 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 · 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 21, 2020 · IPR2019-00846 · APJ Jennifer Meyer Chagnon · IPR · Final written decision

    Claims 3 and 4 are cancelled, and substitute claims 12 and 13 are added; Petitioner did not prove the substitute claims obvious over the asserted combinations.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “understanding of a person of ordinary skill in the art at the time of the invention. Graham, 383 U.S. at 17. Dr. Ducharme testifies that a person of ordinary skill in the art “would have had at least an undergraduate degree in mechanical engineering, or equivalent education, training, or experience, with at least two years of experience with [Unmanned Aeriel Vehicles (UAV)].” Ex. 1003 ¶ 72. Dr. Reinholtz testifies that a person of ordinary skill in the art “would have had a bachelor’s degree in mechanical engineering and at least two years of experience designing mechanisms and mechanical structures of the type used in releasable couplings and locking devices. Additional education could substitute for professional experience and significant work experience could substitute for formal education.” Ex. 2001 ¶ 28. Dr. Reinholtz acknowledges that he does not view “Dr. Ducharme’s proposed definition as substantially different from [his own].” Ex. 2001 ¶ 30. We agree and note that our consideration of the issues presented does not turn on which proposed definition is applied. Dr. Ducharme and Dr. Reinholtz also acknowledge that their respective testimony would remain the same regardless of which of these definitions of a person of ordinary skill in the art is applied. See Ex. 1028 ¶ 23; Ex. 2001 ¶ 30. In any event, for purposes of this Final Written Decision, we adopt Petitioner’s description of a person of ordinary skill in the art, while maintaining our prior determination (Inst. Dec. 10) that the prior art reflects the appropriate level of skill at the time of the claimed invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 12

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

      “1. “lugs” and “notches” Claim 1 recites, inter alia, “the shaft lock portion defining notches configured to engage corresponding lugs on the blade lock portion.” Ex. 1001, 6:7–9 (emphasis Petitioner’s (Pet. 23)). In the Institution Decision, we construed “lugs” and “notches,” in accordance with Petitioner’s proposal, as “projections” and “indentations,” respectively. See Inst. Dec. 12; Pet. 24; Ex. 1003 ¶ 86. The parties do not dispute this construction in their subsequent briefing, and we discern no reason to change this construction based on the complete record of this proceeding. Therefore, we maintain our prior construction for purposes of this Final Written Decision.” slip op. at 15

    • PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, grantedGranted

      “claims.” 35 U.S.C. § 316(d)(1)(B); see 37 C.F.R. § 42.121(a)(3) (“A motion to amend may cancel a challenged claim or propose a reasonable number of substitute claims.”). Patent Owner proposes two substitute claims in place of two challenged claims. Revised Mot. Amend 1, 27. “There is a rebuttable presumption that a reasonable number of substitute claims per challenged claim is one (1) substitute claim.” Lectrosonics, Paper 15 at 4; see 37 C.F.R. § 42.121(a)(3). Petitioner does not argue otherwise. See generally Opp. Therefore, we determine that the amendments propose a reasonable number of substitute claims.” slip op. at 18

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

      “screwed onto the wrong driveshaft, when using a conventional threaded attachment mechanism (such as that described in Sasaki) is actually “mistake-proof.” Based on the evidence of record, we determine that it is not. Or, in other words, we determine that the conventional threaded attachment mechanism taught by Sasaki does not teach the Engagement Limitation (i.e., it does not prevent the clockwise lock mechanism from “be[ing] engaged in” the counterclockwise lock mechanism). According to Patent Owner, “the conventional screw-on type blade attachment mechanism does not prevent the attachment of a blade to the wrong drive.” Revised Mot. Amend 15 (citing Ex. 2001 ¶¶ 52–54, 59). Patent Owner contends that “it is relatively easy to attach a blade on the wrong drive on a UAV that utilizes the conventional screw-on type connection mechanism.” Id. (citing Ex. 2001 ¶¶ 52–54); see also Ex. 2006 (video created by Dr. Reinholtz demonstrating that a blade can be attached to the wrong drive using a screw-on type attachment mechanism). In its Reply, Patent Owner argues, again relying on the testimony of Dr. Reinholtz, that “[w]ith a conventional threaded attachment mechanism, when a blade is screwed onto the wrong driveshaft, the blade becomes engaged in the lock mechanism.” Reply 2 (citing Ex. 2016 ¶¶ 20–24). Petitioner, on the other hand, relying on the testimony of Dr. Ducharme, contends that “[w]hen a blade is forced onto the driveshaft and the threads are ‘stripped’, the blade is not, and cannot be, ‘engaged’ with the lock mechanism”; “[r]ather, the metal threads on the shaft lock portion are likely carving out new notches in the blade lock portion.” Opp. 12 (citing Ex. 1028 ¶ 49). According to Patent Owner, however, the “[i]ntent of the UAV designer is not a part of the Engagement Limitation.” Reply 2; see id. (noting that “Petitioner’s position appears to be premised on the incorrect notion that the Engagement Limitation requires the engagement of lock mechanism components in the precise way that is intended by the designer of the UAV”). Patent Owner contends that to “be engaged in,” as properly construed, “include[s] the type of connection between threads when a blade is screwed onto the wrong driveshaft.” Id. at 3. As we have construed it, to “be engaged in” merely requires “being interlocked.” See supra Section II.C.2. Relying on testimony of Dr. Reinholtz, Patent Owner further contends that “when a blade is screwed onto the wrong driveshaft, the threads on the blade mate or interlock with the threads on the driveshaft.” Reply 3 (citing Ex. 2016 ¶¶ 20, 23–24); see also Tr. 31:8–12 (“[A]s Dr. Reinholtz explains [at Ex. 2016 ¶ 23], that when a blade is misthreaded, a mechanical connection is created by engagement between the threads either because threads on the blade are deformed around threads on the shaft or threads on the shaft carved through threads on the blade.”). As shown in Dr. Reinholtz’s video, when the blades are screwed onto the wrong driveshaft, the blade and shaft are locked together (i.e., “interlocked” or “engaged”). Ex. 2006; see also Ex. 2001 ¶ 54 (describing the video, and indicating that the incorrectly installed blades “do not fall off” and are “securely attached”).” slip op. at 32

    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 9,260,184
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