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  • PTAB · Mar 27, 2025 · IPR2024-01451 · APJ Erica A Franklin · IPR · Institution

    The Board instituted review of claims 1–19 on all petition grounds, finding a reasonable likelihood that claim 1 would have been obvious over Larson alone.

    RulingsInstitution decision
    • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied

      “of whether we exercise our discretion to deny institution under 35 U.S.C. § 314(a). Rather, when considering the Fintiv factors, we “take[] a holistic view of whether efficiency and integrity of the system are best served by denying or instituting review.” Fintiv at 6. Here, factors one and six are neutral, factors two and three weigh against discretionary denial, and factors four and five favor denial. We assign less weight to the existence of an overlap in asserted claims and prior art, in view of there being no trial date scheduled in the District Court case and no persuasive evidence that the court’s trial date would be expected to be significantly before the due date of our Final Written Decision. Therefore, after weighing all of the factors, we determine that the facts in this case that weigh against exercising discretion outweigh the facts that favor exercising discretion. Accordingly, we decline to exercise our discretion to deny institution under § 314(a).” slip op. at 13

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “At this stage in the proceeding, Patent Owner does not dispute Petitioner’s description of the person of ordinary skill in the art. Prelim. Resp. 27. In view of this, and because Petitioner’s uncontested description of one of ordinary skill in the art is reasonable and consistent with the ’921 patent and the cited art, we adopt Petitioner’s definition for purposes of this Decision. We note, however, that the open-ended language “at least” expands the range of experience indefinitely with no upper bound. Therefore, we do not apply this aspect of Petitioner’s formulation.” slip op. at 14

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

      “We determine that there is no need to expressly construe any claim term to determine whether to institute an inter partes review. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 controversy, and only to the extent necessary to resolve the controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). To the extent that any discussion regarding the scope of a claim term is relevant to our decision, we address that issue in our analysis of the asserted grounds of unpatentability.” slip op. at 15

    • Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artDecided for patent owner

      “Owner that Petitioner has not demonstrated sufficiently in the Petition, for purposes of institution, that all of the portions of Saxonov relied upon in the Petition are prior art. In particular, we determine that Petitioner has not established that the disputed portions of Saxonov are entitled to claim the benefit of the ’013 provisional filing date because Petitioner has failed to satisfy the second condition for this benefit, i.e., by showing that the provisional application provides sufficient support for certain subject matter in Saxonov relied upon for prior art purposes in the Petition.” slip op. at 28

    Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · Graham
    Patents in suitUS 11,827,921
  • PTAB · Mar 18, 2025 · IPR2024-01378 · APJ Jason W Melvin · IPR · Institution

    The Board instituted inter partes review of claims 1–10 on all petitioned grounds, finding a reasonable likelihood that at least one claim is unpatentable.

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

      “presented in the petition . . . and any response . . . shows that 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) (2018). “When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.” 37 C.F.R. § 42.108(a) (2021).” slip op. at 2

    • BurdenInstituted

      “In sum, Patent Owner asserts that the precise teachings of the asserted secondary references do not amount to detecting electrical conduction through the posterior tibial nerve. That argument does not consider that Petitioner relies on a combination in which Svihra’s approach is modified by the secondary references such that Svihra’s stimulation of the PTN is detected and used to automatically control the stimulation parameters. Pet. 21–28. As discussed, we view the references’ disclosures as supporting Petitioner’s contentions. f. Summary We conclude that Petitioner has identified sufficient reason that skilled artisans would have modified Svihra’s approach to incorporate the systems and techniques of Mann, DiLorenzo, Gerber, and Bourget, and that the asserted combination renders obvious claim 1’s limitations. Accordingly, this ground supports institution.” slip op. at 30

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “of filing “would have had an undergraduate degree in the field of biomedical engineering, or a related discipline, such as electrical engineering, and at least two years of experience in the design and/or analysis of biomedical devices” and that “[a]dditional work experience could substitute for a formal degree and vice versa.” Pet. 14 (citing Ex. 1003 ¶ 21). Patent Owner does not dispute Petitioner’s proposal. See generally Prelim. Resp. Because Petitioner’s proposed level of ordinary skill in the art appears to be consistent with the challenged patent and prior art, we adopt it and use “skilled artisans” to refer to people with such skill at the time the invention was filed.” slip op. at 9

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

      “Petitioner argues that “no terms require construction for purposes of this Petition.” Pet. 14. Patent Owner does not contest Petitioner’s argument. See generally Prelim. Resp. We agree and do not expressly construe any terms at this stage. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (noting that “we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). Should either party believe that a position taken during trial depends on a particular claim construction, we encourage the party to explain that dependence and why its asserted construction is correct.” slip op. at 10

    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · Graham
    Patents in suitUS 9,002,477
  • PTAB · Mar 18, 2025 · IPR2024-01375 · APJ Jason W Melvin · IPR · Institution

    The Board instituted IPR of claims 1–13 based on both §103 grounds, finding a reasonable likelihood that the asserted combinations render at least one challenged claim unpatentable.

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

      “35 U.S.C. § 325(d) because Amarenco and Mann previously were presented to the Office during prosecution of the ’742 patent. See Prelim. Resp. 17–18. According to Patent Owner, Petitioner has identified additional references that “supposedly teach[] only some of what was missing—stimulation of a branch of the posterior tibial nerve but not to treat overactive bladder or incontinence.” Id. at 18. Patent Owner’s argument is flawed for two reasons. First, neither Svihra nor Ponsford were previously presented to the Office. Because Patent Owner does not argue that we should deny institution of Petitioner’s Svihra-based ground under § 325(d), and because that ground relies on a combination of art not previously presented, Patent Owner’s § 325(d) argument is unpersuasive. In that regard, we determine that even if we were to conclude the Amarenco-based ground warranted discretionary denial, the Svihra-based ground would not be subject to such denial and may alone justify institution. See USPTO, SAS Q&As (June 5, 2018) at D1.11 Additionally, for the Amarenco-based ground, Petitioner relies on a combination including prior art that was not previously presented, and Patent Owner does not show that additional prior art is cumulative to art presented during prosecution. We determine that Petitioner’s Amarenco-based ground 11 Available at: https://www.uspto.gov/sites/default/files/documents/ sas_qas_20180605.pdf is not substantially the same as one previously presented to the Office. Thus, we decline to discretionarily deny institution under § 325(d).” slip op. at 8

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “of filing “would have had an undergraduate degree in the field of biomedical engineering or a related discipline, such as electrical engineering, and at least two years of experience in the design and/or analysis of biomedical devices” and that “[a]dditional work experience could substitute for a formal degree and vice versa.” Pet. 21 (citing Ex. 1003 ¶¶ 20–21). Patent Owner does not dispute Petitioner’s proposal. See generally Prelim. Resp. Because Petitioner’s proposed level of ordinary skill in the art appears to be consistent with the challenged patent and prior art, we adopt it, and use “skilled artisans” to refer to people with such skill at the time the invention was filed.” slip op. at 9

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

      “Petitioner argues that “no terms require construction for purposes of this Petition.” Pet. 22. Patent Owner does not contest Petitioner’s position. See generally Prelim. Resp. We agree and do not expressly construe any terms at this stage. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (noting that “we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 9

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

      “It has long been recognized that the touchstone as to whether an asserted reference qualifies as prior art is public accessibility. See In re Hall, 781 F.2d 897, 899 (Fed. Cir. 1986). “[A]t the institution stage, the petition must identify, with particularity, evidence sufficient to establish a reasonable likelihood that the reference was publicly accessible before the critical date of the challenged patent and therefore that there is a reasonable likelihood that it qualifies as a printed publication.” Hulu, LLC v. Sound View Innovations, LLC, IPR2018-01039, Paper 29, 13 (PTAB Dec. 20, 2019) (precedential).” slip op. at 12

    Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
    Patents in suitUS 11,224,742
  • PTAB · Feb 24, 2025 · IPR2024-01312 · APJ Erica A Franklin · IPR · Institution

    The Board instituted review of claims 1, 2, 4-6, 16, 17, and 19-21 on all asserted grounds, finding a reasonable likelihood of unpatentability over Lundahl and Larsen.

    RulingsInstitution decision
    • Skill levelSkill level patent owner adoptedDecided for patent owner

      “justification for requiring a POSITA to have both an engineering degree and a medical degree. We agree, insofar as Petitioner has not clearly set out any particular explanation or evidence in support of its dual-degree requirement. In all other respects, we note that the parties’ proposed definitions are largely similar. Because we determine that Patent Owner’s proposed definition is reasonable and consistent with the ’028 patent and the cited art, we adopt Patent Owner’s definition for purposes of this Decision. In any event, our decision whether to institute does not turn on this level of skill determination.” slip op. at 10

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

      “used to construe the claim in a civil action under 35 U.S.C. § 282(b); 37 C.F.R. § 100(b). Under that standard, claim terms “are generally given their ordinary and customary meaning” as understood by a person of ordinary skill in the art at the time of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc) (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)). See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Petitioner and Patent Owner assert that the Board need not construe any claims for the purpose of deciding whether to institute an inter partes review. Pet. 12; Prelim. Resp. 24. We agree.” slip op. at 10

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

      “Based on our review of the Petition, Petitioner explains that a driving motivation for a POSITA to modify Lundahl to include Larsen’s five panels is “to increase the flexibility of the device to ensure the light panels could be maintained at a distance of 2-4′′ from surface of the treatment area, whether the face, arm, or back, etc.” Pet. 29 (emphasis added). As Lundahl’s device is not flexible, and such flexibility would improve its ability to treat areas other than an average sized face, we determine, at this stage in the proceeding, that this motivation for the combination is sufficient.” slip op. at 20

    • Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightInstituted

      “would have been motivated to modify Lundahl’s device by incorporating Larsen’s use of LEDs on the surface of the light applicators in place of Lundahl’s fluorescent tubes with a reasonable expectation of success. Prelim. Resp. 55. Patent Owner argues that Petitioner’s modification is based on improper hindsight bias because “Petitioner cherry-picks Larsen’s LEDs (together with the five panels) and purports to arrange them according to the [sic] ‘the uneven spacing’ of Lundahl’s fluorescent tubes.” Id. at 56 (citing Pet. 46–49; Ex. 1015 ¶¶ 175–80). According to Patent Owner, “Petitioner cannot on the one hand argue that a ‘POSITA would have understood that Larsen’s applicator is configured to uniformly illuminate a treatment surface of the patient,’ while on the other ignore Larsen’s teaching that the ‘light sources 17 are placed in regular row arrangements.’” Id. Patent Owner asserts that Petitioner’s proposed modification “mish-mashes aspects of Lundahl and Larsen ([while] avoiding the overall teachings of [challenged] claims.” Id. at 56–57. As discussed above, based on our consideration of the current record, Petitioner has provided sufficient motivation for employing Larsen’s flexible five panel configuration. These panels in Larsen already use LEDs as their light source. So, in our view, Petitioner’s incorporation of the five panels includes the lighting source, i.e., LEDs, for those panels taught by Larsen. Further, we note that Petitioner has persuasively asserted that a skilled artisan would have been motivated to use Larsen’s LEDs as they are more cost-efficient and last longer. See Pet. 31.” slip op. at 20

    Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
    Patents in suitUS 11,697,028
  • PTAB · Jan 29, 2025 · PGR2024-00043 · APJ John G New · PGR · Institution

    The Board instituted PGR on all challenged claims, finding a sufficient likelihood that claims are anticipated or obvious under Grounds 1–10; it found Ground 11’s enablement challenge insufficient.

    RulingsInstitution 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.” For the reasons we explain below, we institute post-grant review of the ’943 patent.” slip op. at 2

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

      “asserted reference qualifies as prior art is public accessibility. See In re Hall, 781 F.2d 897, 899 (Fed. Cir. 1986). “[A]t the institution stage, the petition must identify, with particularity, evidence sufficient to establish a reasonable likelihood that the reference was publicly accessible before the critical date of the challenged patent and therefore that there is a reasonable likelihood that it qualifies as a printed publication.” Hulu, LLC v. Sound View Innovations, LLC, IPR2018-01039, Paper 29, 13 (PTAB Dec. 20, 2019) (precedential).” slip op. at 15

    • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportDecided for petitioner

      “priority benefit of the ’720 provisional application (at top center). See Ex. 1001, code (60) (listing “provisional application No. 5,995,873, filed on Oct. 2, 2006”). However, simply to claim the priority benefit of an earlier application is not necessarily to receive it. See In re NTP, Inc., 654 F.3d 1268, 1276 (Fed. Cir. 2011) (holding that “a patent’s claims are not entitled to an earlier priority date merely because the patentee claims priority.… Rather, for a patent’s claims to be entitled to an earlier priority date, the patentee must demonstrate that the claims meet the requirements of 35 U.S.C. § 120.”). As the diagram shows (and as we have verified), the ’529 application was a continuation-in-part of the preceding ’329 application. See Ex. 1001, code (63). However, the ’529 application was abandoned on February 10, 2016 (See Ex. 1052), and the succeeding application, U.S. Patent Application Ser. No. 15,474,875 (the “’875 application”) which is listed in the ’943 patent as being a continuation-in-part of the ’529 application, was not filed until March 30, 2017. See Ex. 1001, code (63) (stating that “said application No. 15/474,875 is a continuation-in-part of application No. 12/508,529”). Put simply, the ’875 application was not filed until over a year after the ’529 application was abandoned. As 35 U.S.C. § 120 states, in relevant part: An application for patent for an invention disclosed in the manner provided by section 112(a) (other than the requirement to disclose the best mode) in an application previously filed in the United States, or as provided by section 363 or 385, which names an inventor or joint inventor in the previously filed application shall have the same effect, as to such invention, as though filed on the date of the prior application, if filed before the patenting or abandonment of or termination of proceedings on the first application or on an application similarly entitled to the benefit of the filing date of the first application and if it contains or is amended to contain a specific reference to the earlier filed application. (emphasis added). In other words, if there is a “break in the chain” of priority caused by the abandonment or termination of an application claiming priority prior to filing of a subsequent application, the subsequent application loses the priority benefit of the abandoned or terminated application, as well as the priority benefit of all applications that antedate that abandoned or terminated application. Such is the case presently before us. Based on the current record, we are persuaded that the abandonment of the ’529 application prior to filing of the continuation-in-part ’875 application broke the priority chain leading to the ’720 provisional application, and the ’943 patent cannot, therefore, claim the priority benefit of the ’720 provisional application’s October 2, 2006 filing date. Consequently, the earliest date of which the ’943 patent could possibly claim the priority benefit is that of U.S. Patent Provisional Application Ser. No. 61/403,680 (the “’680 provisional application”) (located at the top of the left branch of the “family tree” depicted above), which has a filing date of September 20, 2010. See Ex. 1001, code (60). Burnett (i.e., the ’329 application) was filed on October 2, 2007 and thus antedates the ’680 provisional application. Consequently, Patent Owner’s argument fails based on the current record, and Burnett is prior art to the ’943 patent.” slip op. at 55

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

      “Patent Owner’s request that we exercise our discretion under § 325(d) is not tenable. In deciding whether to exercise our discretion under § 325(d) in situations where only some of the challenges fall within its scope, we evaluate the challenges and determine whether § 325(d) is sufficiently implicated that its statutory purpose would be undermined by instituting on all challenges. If so, the panel will evaluate whether the entire petition should be denied.” See USPTO, SAS Q&As (June 5, 2018) at D1, available at: https://www.uspto.gov/sites/default/files/ documents/ sas_qas_20180605.pdf; see also Kansas State Univ. Res. Found., PGR2022- 00021, Paper 11 at 7–8 & n.3 (Vidal Feb. 24, 2023) (holding that “the Board will further evaluate … whether § 325(d) is sufficiently implicated that its statutory purpose would be undermined by instituting review on all challenges presented in the Petition”). We having instituted post grant review based at least upon claim 1 of Ground 1 of the Petition. Even if the panel agreed with Patent Owner that Grounds 5–8 present “the same or substantially the same prior art or arguments” previously presented to the Office, § 325(d) would not be “sufficiently implicated” due to the 7 other asserted grounds. We therefore do not proceed with the § 325(d) analysis established in Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential) and decline to exercise our discretion to deny the petition on that basis.” slip op. at 41

    Claim construction§ 102 anticipation§ 112 disclosureDiscretionary denialcites Phillips · KSR
    Patents in suitUS 11,844,943
  • PTAB · Jan 27, 2025 · IPR2024-00965 · APJ Zhenyu Yang · IPR · Institution

    Instituted review of claims 1–6 on all asserted grounds because Petitioner showed a reasonable likelihood of prevailing on at least one challenged claim.

    RulingsInstitution decision
    • 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). Accordingly, we institute inter partes review of all challenged claims based on the ground raised in the Petition.” slip op. at 2

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

      “We agree with Patent Owner that testimony from a “custodian with any personal knowledge of arXiv.org or its regular practices” would have strengthened Petitioner’s argument that Gloor is prior art. See Prelim. Resp. 20; see also, e.g., Murray & Poole Enters. LTD v. Institut De Cardiologie De Montreal, IPR2023-01064, Paper 49 (PTAB Jan. 14, 2025) (considering testimony regarding the internet archive service known as the Wayback Machine (https://web.archive.org/) in determining public accessibility). At the institution stage, however, Petitioner needs to show that Gloor qualifies as prior art by “a reasonable likelihood” standard. See Hulu, LLC, v. Sound View Innovations, LLC, IPR2018-01039, Paper 29, 13 (PTAB Dec. 20, 2019) (precedential) (“[A]t the institution stage, the petition must identify, with particularity, evidence sufficient to establish a reasonable likelihood that the reference was publicly accessible before the critical date of the challenged patent and therefore that there is a reasonable likelihood that it qualifies as a printed publication.”). We find that, for purposes of institution, Petitioner has met its burden to show a reasonable likelihood that Gloor was publicly accessible before the priority date of the ’200 patent. To prevail in this inter partes review, Petitioner must meet the preponderance of the evidence standard. See 35 U.S.C. § 316(e). Thus, we encourage the parties to fully develop the record during trial to facilitate the ultimate resolution of this issue.” slip op. at 9

    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner

      “institution under § 325(d). Prelim. Resp. 21–29. Under 35 U.S.C. § 325(d), in determining whether to institute an inter partes review, “the Director may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.” Our § 325(d) analysis employs a two-prong framework: (1) whether the arguments presented in the petition are the same or substantially the same as those previously presented to the Office; and (2) if so, whether the petitioner has demonstrated a material error by the Office in its prior consideration of those arguments. Advanced Bionics, LLC v. Med-El Electromedizinishe Gerӓte GmbH, IPR2019-01469, Paper 6 (“Advanced Bionics”), 8 (PTAB Feb. 13, 2020) (precedential).” slip op. at 11

    § 102 anticipationDiscretionary denialcites Phillips
    Patents in suitUS 11,768,200
  • PTAB · Jan 27, 2025 · IPR2024-01197 · APJ Tawen Chang · IPR · Institution

    The Board instituted IPR on all challenged claims, 1–40, and all petitioned grounds after finding a reasonable likelihood of unpatentability and declining § 325(d) denial.

    RulingsInstitution decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Patent Owner has not proposed a definition of a person of ordinary skill in the art in its Preliminary Response. On the current record, for purposes of this Decision, we apply Petitioner’s proposed definition, as it appears consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’729 Patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the 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, however, that the open-ended language “at least” and “or more” expands the range of experience indefinitely with no upper bound. Therefore, we do not apply this aspect of Petitioner’s formulation.” slip op. at 15

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

      “Petitioner bears the burden of stating “[h]ow the challenged claim is to be construed.” 37 C.F.R. § 42.104(b)(3). However, only those terms that are in controversy need be construed, and only to the extent necessary to resolve the controversy. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). Based on the preliminary record, we find it unnecessary to construe any claim term to decide whether Petitioner satisfies the “reasonable likelihood” standard for instituting trial. Any final written decision entered in this case may include express” slip op. at 17

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

      “5. Conclusion as to Ground 1 Based on the foregoing discussion, and having considered the arguments and evidence presented by Petitioner, including the presently unrebutted testimony of Dr. Parr, we are persuaded Petitioner has shown a reasonable likelihood of prevailing with respect to Ground 1 sufficient for purposes of institution. E. Other Asserted Grounds of Unpatentability Having determined that Petitioner meets the threshold showing necessary to support institution of review based on the ground that asserts obviousness over Dohil in view of the knowledge of a POSA, we decline to address whether any other ground asserted in the Petition also supports institution. See Pet. 15–16 (grounds chart); see also SAS, 138 S. Ct. at 1359–60 (requiring the Board’s final written decision to address every claim the petitioner presents for review); Patent Trial and Appeal Board Consolidated Trial Practice Guide7 (“Trial Practice Guide”) (Nov. 2019) 11 (“The Board will not institute on fewer than all claims or all challenges in a petition.”); PGS Geophysical, 891 F.3d at 1359–1360. We emphasize our determination in this Decision is not a final determination on the construction of any claim term or the patentability of any challenged claim and, thus, leaves undecided any factual issues necessary to determine whether sufficient evidence supports Petitioner’s contentions by a preponderance of the evidence in the final written decision.” slip op. at 23

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

      “additional evidence and facts presented in the Petition warrant reconsideration of prior art or arguments,” we agree with Petitioner that the Examiner materially erred because the Examiner did not have the benefit of the teachings of the FDA Guidance, which Petitioner relies on in Grounds 1 (Dohil) and 3 (Dohil and Venkatesh) as representative of the knowledge of a POSA with regard to orally disintegrating tablets. See, e.g., Pet. 23.” slip op. at 36

    Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
    Patents in suitUS 8,771,729
  • PTAB · Jan 27, 2025 · IPR2024-00964 · APJ Zhenyu Yang · IPR · Institution

    The Board instituted IPR on claims 1–8 based on both asserted obviousness grounds: Parameswaran with Gloor and Parameswaran with Bentley.

    RulingsInstitution decision
    • 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). Accordingly, we institute inter partes review of all challenged claims based on the ground raised in the Petition.” slip op. at 2

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

      “We agree with Patent Owner that testimony from a “custodian with any personal knowledge of arXiv.org or its regular practices” would have strengthened Petitioner’s argument that Gloor is prior art. See Prelim. Resp. 27; see also, e.g., Murray & Poole Enters. LTD v. Institut De Cardiologie De Montreal, IPR2023-01064, Paper 49 (PTAB Jan. 14, 2025) (considering testimony regarding the internet archive service known as the Wayback Machine (https://web.archive.org/) in determining public accessibility). At the institution stage, however, Petitioner needs to show that Gloor qualifies as prior art by “a reasonable likelihood” standard. See Hulu, LLC, v. Sound View Innovations, LLC, IPR2018-01039, Paper 29, 13 (PTAB Dec. 20, 2019) (precedential) (“[A]t the institution stage, the petition must identify, with particularity, evidence sufficient to establish a reasonable likelihood that the reference was publicly accessible before the critical date of the challenged patent and therefore that there is a reasonable likelihood that it qualifies as a printed publication.”). We find that, for the purposes of institution, with Dr. Gloor’s declaration and the supporting exhibits attached therein, Petitioner has met this burden. To prevail in this inter partes review, Petitioner must meet the preponderance of the evidence standard. See 35 U.S.C. § 316(e). Thus, we encourage the parties to fully develop the record during trial to facilitate the ultimate resolution of this issue.” slip op. at 12

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

      “detailed analysis to support its argument that the combination of Parameswaran and Gloor teaches or suggests each limitation of claim 1. Pet. 23–36. Petitioner also contends that an ordinarily skilled artisan would have been motivated combine the teachings of the two references and would have had a reasonable expectation of success in doing so. Id. at 36–45. Patent Owner counters that the combination does not teach or suggest two limitations, namely the amplifying and discarding steps of the method. Prelim. Resp. 18–24. Patent Owner also challenges Gloor’s prior art status. Id. at 24–28. Based on the current record, we find Petitioner’s argument with respect to the amplifying and discarding steps more persuasive. With respect to the remaining limitations, we find persuasive Petitioner’s analysis on the prior art’s teachings. We also find persuasive Petitioner’s analysis on the motivation to combine and reasonable expectation of success. For the purposes of institution, we adopt those analyses as our own. We address Patent Owner’s counterarguments below.” slip op. at 9

    • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Instituted

      “cross-over events (id. at 18–21). Based on the current record, we find Petitioner’s argument more persuasive. Petitioner relies on the combination of Parameswaran and Gloor as teaching the amplifying step. See Pet. 31–33. As such, Patent Owner cannot show non-obviousness “by attacking references individually.” In re Keller, 642 F.2d 413, 426 (CCPA 1981). Patent Owner argues that “because Parameswaran used pyrosequencing on the surface of beads in a Roche 454 sequencer, it does not disclose the formation of clusters.” Prelim. Resp. 21 (citing Pet. 31). Petitioner, however, relies on Gloor for teaching “amplifying said nucleic acid templates on a surface of a flow cell thereby to form clusters.” Pet. 31–32. Patent Owner does not challenge this reliance. See generally Prelim. Resp. Patent Owner contends that Petitioner “equat[es] the claimed chimeric sequences with ‘mismatched’ or ‘misassigned’ sequences containing an ‘unexpected’ pair of forward and reverse barcode motifs identified in Parameswaran.” Prelim. Resp. 18–19. But, according to Patent Owner, “Petitioner does not point to any disclosure in Parameswaran identifying these “mismatched” motifs as chimeric sequences—as opposed to mere sequencing or sample handling error—nor does Petitioner cite any disclosure in Parameswaran regarding such sequences resulting from cross-over events.” Id. at 19. We find Patent Owner’s characterization of Petitioner’s argument inaccurate. As we understand it, Petitioner does not “equat[e]” the claimed chimeric sequences with “mismatched” sequences in Parameswaran. Instead, as Patent Owner acknowledges, “Petitioner argues that ‘sequences with mismatched barcode motifs’ in Parameswaran ‘include chimeric sequences resulting from cross-over events.’” Id. (quoting Pet. 32) (emphasis added).” slip op. at 14

    § 102 anticipation§ 103 obviousnesscites Phillips
    Patents in suitUS 11,041,852
  • PTAB · Dec 6, 2024 · IPR2024-00711 · APJ Erica A Franklin · IPR · Institution

    The Board instituted review of claims 1–3 and 8 on all asserted grounds, finding a reasonable likelihood that Chen anticipates or renders obvious each challenged claim.

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

      “Accordingly, we determine that Petitioner has shown a reasonable likelihood of prevailing in its challenge of claims 1–3, and 8 as anticipated by, or obvious over Chen.” slip op. at 24

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Patent Owner does not specifically address or dispute Petitioner’s proposed definition or a person of ordinary skill in the art. See generally Prelim. Resp. At this stage of the proceeding, we adopt Petitioner’s proposed level of ordinary skill in the art as we find it consistent with the cited prior art and it is undisputed on this record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate” slip op. at 6

    • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner

      “of independent claims 1, 2, and 8 are limiting. Prelim. Resp. 7. According to Patent Owner, for these claims, the preamble “recites specific steps in the process that are not recited in the body of the claim or are recited in a way particulate matter; infecting an individual through nasal inhalation; formulation is applied to the skin or tissue of nasal passages; and a thin film.” Id. Petitioner does not allege any contention regarding whether the preamble is limiting. See Pet. 14–16. Based on our review, we agree with Patent Owner that the preamble of independent claims 1, 2, and 8 limits the challenged claims as both the preamble and the body have been used to define the subject matter claimed. See Allen Engineering Corp., v. Bartell Industries, Inc., 299 F.3d 1336, 1346 (Fed. Cir. 2002). In particular, the preamble is “necessary to give life, meaning and vitality” to the claim, see id., because it provides the only description in the claim for the application site of the formulation, i.e., “to skin or tissue of nasal passages,” and how the formulation is applied, i.e., “in a thin film.” Id.” slip op. at 7

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

      “one “biocidic agent.” Petitioner asserts that this term means “an agent which has the capacity to neutralize, inactivate, render harmless or kill airborne particles, which include microorganisms, for example viruses and/or bacteria.” Pet. 14. Patent Owner asserts that the term refers to “a chemical substance that destroys or inhibits the growth or activity of living organisms.” Prelim. Resp. 12 (citing Merriam-Webster Dictionary). Independent claim 2 recites a formulation comprising at least one “cationic agent.” Dependent claim 3 recites that the “cationic agent is a polymeric quaternary ammonium compound.” Patent Owner asserts that a “cationic agent” is “a chemical substance that creates a positive electrostatic term. Based on our review, we determine that an explicit construction is not necessary for purposes of our determination whether to institute an inter partes trial, as there is no dispute as to whether the prior art discloses formulations comprising a biocidic agent and a cationic agent.” slip op. at 8

    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 8,163,802
  • PTAB · Apr 24, 2023 · IPR2023-00074 · APJ Erica A Franklin · IPR · Institution

    The Board instituted IPR on claims 1, 2, 5–8, 11, and 15 on all asserted grounds, finding a reasonable likelihood that claims 1, 2, 5–7, and 11 are obvious over the May Article.

    RulingsInstitution decision
    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner

      “Based on our review of the record, we find that Petitioner has not shown persuasively that the Examiner did not consider the same or substantially the same art that Petitioner relies upon for its obviousness challenges. Petitioner’s grounds primarily rely on three different “May” references, only one of which the Examiner considered during prosecution, i.e., the May Article. The additional primary references relied upon by Petitioner are the May Thesis, which provides a more detailed disclosure than the May Article, and the May Abstract, which provides less detail than the May Article, in terms of the HS2, HS3, and HS4 fragments used to generate the disclosed TNS9 vector. Those differences are only material with respect to whether each reference discloses the fragments as recited in independent claim 1, or renders those fragments obvious. As discussed in Section II.D.2., however, we determine that the May Thesis is not prior art. 11 The ’221 application claims priority to provisional application no. 60/301,861 (Ex. 1034) (“the ’861 provisional application”), filed June 29, 2001, and provisional application no. 60/302,852 (Ex. 1035) (“the ’852 provisional application”), filed on July 2, 2001, referred to, collectively, as “the provisional applications,” “the provisionals” and “the Provisionals.” Article, but in less detail, the May Abstract may be considered cumulative to the May Article. Because the May Thesis provides more explicit details regarding the fragments disclosed in the May Article, it may not be considered to be cumulative to the May Article. However, as discussed in Section II.D.2., we determine that the May Thesis is not prior art. When considering the extent of the overlap between the arguments made during examination and the manner in which Petitioner relies on the May Article or Patent Owner distinguishes the May Article, we note that Patent Owner alleged during prosecution and here that the May Article is not prior art for a number of reasons, including that it is the work of the inventors and that it was published one year or less before the priority date asserted by Patent Owner for the challenged claims. We note also that Petitioner contends that the challenged claims are not entitled to the priority date asserted by Patent Owner, and recognized by the Examiner. Based on the foregoing, we conclude that substantially the same prior art that Petitioner relies upon was previously presented to the Examiner during prosecution. The first part of the § 325(d) framework is, therefore, met. Accordingly, we turn to the second part of the § 325(d) and determine whether error by the Office has been shown. See Advanced Bionics at 8.” slip op. at 10

    • Skill levelSkill level petitioner adoptedOther

      “Petitioner asserts that a person of ordinary skill in the art (“POSA”) “at the time of the alleged invention would have had: (1) at least an advanced degree (e.g., a Master’s or Ph.D.) in biochemistry, biotechnology, protein chemistry, genetics, molecular and structural biology, bioengineering, or similar disciplines.” Pet. 18–19 (citing Ex. 1002 ¶¶ 14– 15). Petitioner further asserts that a POSA would have had “(2) several years of post-graduate training or related experience in one or more of these areas” and “(3) an understanding of vector design and the effect of LCR fragments on gene expression, including experience with how the LCR regulates gene expression.” Id. At this stage in the proceeding, Patent Owner does not dispute Petitioner’s description of the level of ordinary skill in the art. See Prelim. Resp. Because Petitioner’s uncontested definition of one of ordinary skill in the art is reasonable and consistent with the ’061 patent and the prior art of record, we adopt Petitioner’s definition for purposes of this Decision.” slip op. at 15

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

      “Petitioner states that “that no term of the ’061 patent requires construction to resolve the challenges in this Petition.” Pet. 25 (citing Ex. 1002 ¶¶ 50–51) (footnote omitted). Patent Owner does not argue for any express claim constructions. See Prelim. Resp. Based upon our review of the current record, we determine that no claim terms require express construction for purposes of deciding whether to institute an inter partes review of the challenged claims. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (Only those terms that are in controversy need be construed, “and only to the extent necessary to resolve the controversy.”).” slip op. at 16

    • Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner

      “written description requirement, the disclosure as originally filed does not have to provide in haec verba support for the claimed subject matter at issue.” Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000). Rather, “the test for sufficiency is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010). Based on our consideration of the arguments and evidence presented at this stage of the proceeding, we determine, for purposes of this Decision, that claims 1, 2, 5–7, and 11 of the ’061 patent are not entitled to receive benefit of the filing date for either the ’861 provisional application or the ’852 provisional application. In particular, we find persuasive Petitioner’s arguments that the provisional applications do not satisfy the written description requirements of 35 U.S.C. § 112 for those claims. Independent claim 1 recites, in part, “a recombinant lentiviral vector which comprises a nucleic acid encoding a functional globin operably linked to a 3.2-kb nucleotide fragment . . . said vector providing expression of the globin in a mammal in vivo.” Ex. 1001, 11:57–67. Independent claim 11 recites, in part, “a recombinant lentiviral vector comprising a nucleic acid encoding a functional globin operably linked to a 3.2-kb nucleotide fragment . . . said vector providing expression of the globin in a mammal in vivo.” Ex. 1001, 12:64–13:7. Based upon our review, we agree with Petitioner that these limitations are not adequately described in the provisional applications. The ’061 patent Specification (and the ’221 Application) describe the term “functional globin gene” as: that does not produce a hemoglobinopathy phenotype, and which is effective to provide therapeutic benefits to an individual with a defective globin gene. The functional globin gene may encode a wild-type globin appropriate for a mammalian individual to be treated, or it may be a mutant form of globin, preferably one which provides for superior properties, for example superior oxygen transport properties. . . . Suitably, the globin may encode α-globin, β-globin, or γ-globin. Ex. 1001, 2:44–55 (emphasis added); see also Ex. 1032, 3:24–4:3 (same). Based on this description, we agree with Petitioner that the ’061 patent claims cover a recombinant vector comprising a nucleic acid encoding a “functional globin” genus that includes wild-type globin and mutant forms of globin, wherein the globin may encode different globin types, i.e., α-, β-, or γ-globin. Patent Owner does not identify, nor do we see, any portion of the provisional applications describing the genus of functional globin. Rather, as Petitioner demonstrates, the provisional applications describe one species of that genus, i.e., the wild-type human β-globin. Pet. 14–18. The provisionals do not describe the “functional globin” genus. Indeed, as Petitioner correctly asserts, during the ’061 patent prosecution, Applicants/Patent Owner, relied on a description of “functional globin,” quoted above, that does not appear and has not counterpart in the provisional applications. Compare Ex. 1001, 2:44–55 and Ex. 1032, 3:24–4:3 with Ex. 1034 and Ex. 1035.” slip op. at 21

    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · Graham
    Patents in suitUS 8,058,061
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