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  • PTAB · Dec 16, 2025 · IPR2025-01047 · APJ Hyun J Jung · IPR · Institution

    The Board instituted IPR of claims 1–44 on all presented challenges, finding a reasonable likelihood that FreightCar would prevail on at least one claim based on Hart, the 1906 Cyclopedia, and Wong.

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

      “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.” Upon consideration of the Petition and for the reasons explained below, we determine that Petitioner has shown a reasonable likelihood of prevailing with respect to at least one of the challenged claims. Thus, we institute an inter partes review of claims 1–44 of the ’515 patent on all presented challenges. 37 C.F.R. § 42.108(a) (2024) (“When instituting . . . 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.”); see also SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018).” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “The parties agree that one of ordinary skill in the art “would have had at least a bachelor’s degree in a discipline related to mechanical engineering, physics, structural design, or an equivalent discipline, and at least two years of experience designing or analyzing rail cars.” Pet. 29; Prelim. Resp. 9. Patent Owner, however, disagrees that the experience should include designing or analyzing “similar vehicles.” Prelim. Resp. 9. At this stage, for the reasons below, limiting the ordinary skill in the art to “at least two years of experience designing or analyzing rail cars” does not affect our analysis of the parties’ dispute or our determination that there is a reasonable likelihood that Petitioner would prevail with respect to at least one of the challenged claims. Thus, based on the preliminary record, we adopt Petitioner’s proposed level of ordinary skill to determine whether review should be instituted. Patent Owner also argues that Petitioner’s declarant does not have “actual industry experience with railcar structures” and, thus, “makes the wrong conclusions and conflates various concepts that a [person of ordinary skill in the art] with practical industry experience and knowledge of rail cars would not.” Prelim. Resp. 9–10 (citing Ex. 2035 ¶ 35). For the reasons discussed below, in our preliminary analysis, we give credit to the cited testimony of Petitioner’s declarant, because it finds support in the relied-upon portions of the record.” slip op. at 10

    • Expert testimonyPetitioner expert creditedDecided for petitioner

      “Patent Owner also argues that Petitioner’s declarant does not have “actual industry experience with railcar structures” and, thus, “makes the wrong conclusions and conflates various concepts that a [person of ordinary skill in the art] with practical industry experience and knowledge of rail cars would not.” Prelim. Resp. 9–10 (citing Ex. 2035 ¶ 35). For the reasons discussed below, in our preliminary analysis, we give credit to the cited testimony of Petitioner’s declarant, because it finds support in the relied-upon portions of the record.” slip op. at 10

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

      “to further support the upper, outboard end of the slope sheet with a crosswise, L-shaped beam as in Wong,” and one of ordinary skill in the art would have been motivated to do so, because of “the benefits of reinforcing the slope sheet at its upper end, where its connection with another structure creates a stress concentration.” Pet. 63 (citing Ex. 1003 ¶ 108). Petitioner points to Hart’s transverse beam b3 and argues that it suggests using a transverse beam like Wong if Hart is modified so that upper beam b3 no longer supports the slope sheet. Id. (citing Ex. 1008, Fig. 1). Petitioner also argues that the references are in the same field and that there would have been a reasonable expectation of success. Id. at 63–64 (citing Ex. 1003 ¶ 108; Ex. 1008, Fig. 1). Based on the preliminary record, Petitioner shows that its proposed combination of Hart, the 1906 Cyclopedia, and Wong teaches or suggests the above-quoted limitations of claim 24 and that one of ordinary skill in the art would have combined those references in the manner asserted with a reasonable expectation of success.” slip op. at 19

    § 103 obviousnesscites Phillips · KSR
    Patents in suitUS 8,132,515
  • PTAB · Nov 19, 2025 · IPR2025-00948 · APJ Michael J Fitzpatrick · IPR · Institution

    The Board instituted IPR on all claims 1–23, finding a reasonable likelihood that claim 11 would have been obvious over Herrstedt, Bös, and Herrington.

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

      “Institution of an inter partes review requires that “the information presented in the petition filed under section 311 and any response filed under section 313 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). Determining whether to institute has been delegated to the Board. See 37 C.F.R. § 42.4(a) (“The Board institutes the trial on behalf of the Director.”). Upon consideration of the Petition and the Preliminary Response, and for the reasons explained below, we determine that there is a reasonable likelihood that Petitioner would prevail with respect to at least one claim. Accordingly, we grant the Petition.” slip op. at 2

    • Skill levelOther

      “At this stage, we need not resolve the parties’ dispute with regard to the requisite level of skill in the art, as our analysis would be the same under either party’s definition of a POSA. We note, however, that Petitioner’s definition seems to be overly broad insofar as it would only require the POSA to be skilled in one of several broad fields, including “statistics” and “medical policy and decision making,” that do not directly relate to the claimed subject matter. At the same time, we do not agree with Patent Owner that the POSA needs specific clinical experience in the field of oncology. The claimed subject matter relates to the treatment of a side-effect associated with cancer therapy (CINV), and not the cancer itself. We also recognize that the prior art and the ’357 patent itself reflect the level of skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“[T]he absence of specific findings on the level of skill in the art does not give rise to reversible error where the prior art itself reflects an appropriate level and a need for testimony is not shown.”). We further find, based on the present record, that both parties’ experts are qualified to testify from the perspective of a POSA in this proceeding. See Ex. 1009 ¶¶ 1–7 (Dr. Peroutka’s qualifications); Ex. 2069 ¶¶ 8–15 (Dr. Navari’s qualifications); Kyocera Senco Indus. Tools Inc. v. Int’l Trade Comm'n, 22 F.4th 1369, 1377 (Fed. Cir. 2022) (“[T]o be qualified to offer expert testimony on issues from the vantage point of an ordinarily skilled artisan in a patent case, an expert must at a minimum possess ordinary skill in the art.”). Even if some specific experience with regard to the treatment” slip op. at 9

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

      “First, Petitioner proposes that “therapeutically effective amount” (recited in both independent claims) means: an amount sufficient to elicit the desired biological response. Pet. 9 (citing Ex. 1003, 8:13–15). The cited portion of the Specification clearly supports such a construction. Ex. 1003, 8:13–15 (“As used herein, ‘therapeutically effective amount’ refers to an amount sufficient to elicit the desired biological response.”). We adopt it. Second, Petitioner proposes that “the word if in claims 1 and 11 appears from context to mean ‘is’.” Id. (citing Ex parte Tanksley, 26 USPQ2d 1384, 1387 (BPAI 1991)). Both of the independent claims conclude with the following clause: “and said single dose of netupitant or pharmaceutically acceptable salt thereof if effective to treat said nausea and vomiting for said five consecutive days.” (Emphasis added). The word “if” cannot mean “is,” as Petitioner literally proposes. Pet. 9. However, we understand Petitioner to be arguing implicitly that (1) “if” was a typographical or other error in the independent claims and (2) “is” was intended in its place. Such is a reasonable position in the context of the challenged claims. On the instant record, with no argument to the contrary by Patent Owner, we construe claims 1 and 11 such that the word “is” was intended in lieu of the word “if” in the last clause of each claim. Cf. Canatex Completion Sols., Inc., v. Wellmatics, LLC, No. 2024-1466, 2025 WL 3153362, at *5 (Fed. Cir. Nov. 12, 2025) (“[W]e have ruled that a district court may correct obvious minor typographical and clerical errors in patents.”) (cleaned up; citations omitted)).” slip op. at 10

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

      “Third, Petitioner proposes a construction for “minimum effective dose of dexamethasone.” Pet. 10. That term appears nowhere in the challenged claims. Accordingly, we do not interpret the term.” slip op. at 11

    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 9,943,515
  • PTAB · Nov 19, 2025 · IPR2025-00945 · APJ Sheridan K Snedden · IPR · Institution

    The Board instituted IPR on claims 1–25 after finding a reasonable likelihood that claim 19 would have been obvious over MASCC and Hoffmann.

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

      “We have the authority to determine whether to institute an inter partes review. 35 U.S.C. § 314; 37 C.F.R. §42.4(a). We may not institute an inter partes review “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). Upon consideration of the Petition and the Preliminary Response, and for the reasons explained below, we determine that there is a reasonable likelihood that Petitioner would prevail with respect to at least one claim. Accordingly, we grant the Petition” slip op. at 2

    • PTAB / AIA Trials › Real party in interest / privityOther

      “Each party identifies itself as the sole real party in interest (RPI). Pet. 69; Paper 4, at 1. There is no dispute over RPIs in this proceeding. B. Related Matters” slip op. at 2

    • Skill levelOther

      “At this stage, we need not resolve the parties’ dispute with regard to the requisite level of skill in the art, as our analysis would be the same under either party’s definition of a POSA. We note, however, that Petitioner’s definition seems to be overly broad insofar as it would only require the POSA to be skilled in one of several broad fields, including “statistics” and “medical policy and decision making,” that do not directly relate to the claimed subject matter. At the same time, we do not agree with Patent Owner that the POSA needs specific clinical experience in the field of oncology. The claimed subject matter relates to the treatment of a side-effect associated with cancer therapy (CINV), and not the cancer itself. We also recognize that the prior art and the ’826 patent itself reflect the level of skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“[T]he absence of specific findings on the level of skill in the art does not give rise to reversible error where the prior art itself reflects an appropriate level and a need for testimony is not shown.”). We further find, based on the present record, that both parties’ experts are qualified to testify from the perspective of a POSA in this proceeding. See Ex. 1009 ¶¶ 1–7 (Dr. Peroutka’s qualifications); Ex. 2067 ¶¶ 8–15 (Dr. Navari’s qualifications); Kyocera Senco Indus. Tools Inc. v. Int’l Trade Comm'n, 22 F.4th 1369, 1377 (Fed. Cir. 2022) (“[T]o be qualified to offer expert testimony on issues from the vantage point of an ordinarily skilled artisan in a patent case, an expert must at a minimum possess ordinary skill in the art.”). Even if some specific experience with regard to the treatment of CINV is required, Dr. Peroutka appears to have published in that field. See, e.g., Ex. 1020 at 10, (publication 16: article on “Combination antiemetics” in Cancer Treatment Reports); id. at 11 (publication 37: article on “Neurotransmitter receptor binding studies predict antiemetic efficacy and side effects” in Cancer Treatment Reports); id. at 13 (publication 51: article on “Chemotherapeutic agents do not interact with neurotransmitter receptors” in Cancer Chemotherapy and Pharmacology). B. Claim Construction” slip op. at 11

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionNo construction neededOther

      “First, Petitioner proposes that “therapeutically effective amount” (recited in both independent claims) means: an amount sufficient to elicit the desired biological response. Pet. 9 (citing Ex. 1001, 7:55–57). The cited portion of the Specification clearly supports such a construction. Ex. 1001, 7:55–57 (“As used herein, ‘therapeutically effective amount’ refers to an amount sufficient to elicit the desired biological response.”). We adopt it. Second, Petitioner proposes a construction for “minimum effective dose of dexamethasone.” Pet. 9. That term appears nowhere in the challenged claims. Accordingly, we do not interpret the term. Finally, Petitioner proposes construing the following language appearing in claim 1: “administering to said patient on day one netupitant or a pharmaceutically acceptable salt thereof, in a therapeutically effective amount which enters the systemic circulation, crosses the blood brain barrier and occupies at least 70% of neurokinin-1 (NK1) receptors in the striatum seventy-two hours after said administration.” Pet. 9–10 (emphasis added). Specifically, Petitioner proposes that the italicized language, as introduced by the word “which,” denotes inherent properties (and not further limitations) resulting from the administering of the drug in a therapeutically effective amount. Id. On the instant record, with no argument to the contrary by Patent Owner, we agree with Petitioner. However, we do not explicitly address claim 1 below. Instead, the focus of our institution analysis is independent claim 19. We do not perceive a need to construe expressly any other claim term of the ’826 patent for purposes of determining whether to institute trial. C. Summary of Asserted References” slip op. at 13

    Claim construction§ 103 obviousnesscites Graham
    Patents in suitUS 8,623,826
  • PTAB · Nov 6, 2025 · IPR2025-00820 · APJ Neil T Powell · IPR · Institution

    The Board instituted IPR on claims 1–11 on all petition grounds, finding a reasonable likelihood that claim 1 would have been obvious over Tadros, Porter, Kalili, and Texin 990R.

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

      “review. See 35 U.S.C. § 314; 37 C.F.R. § 42.4(a). To institute an inter partes review, we must determine that the information presented in the Petition and the Preliminary Response shows “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 set forth below, we determine that there is a reasonable likelihood that Petitioner will prevail with respect to at least one challenged claim. We institute an inter partes review of claims 1–11 based on the grounds set forth in the Petition.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Pet. 17–18 (citing Ex. 1007 ¶¶ 13–15). Patent Owner does not dispute Petitioner’s explanation of the level of skill in the art. See generally Prelim. Resp. At this stage of the proceeding and on the present record, we adopt Petitioner’s uncontested proposed level of ordinary skill in the art, which we find consistent with the level of ordinary skill in the art reflected by the ’090 patent and the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978).” slip op. at 8

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

      “Additionally, only terms that are in controversy need to be construed, and these need be construed only to the extent necessary to resolve the controversy. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 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)). Both parties indicate that no claim terms need to be expressly construed. Pet. 29–30; Prelim. Resp. 5. Consistent with that, we determine that we need not construe any claim terms expressly in order to resolve the parties’ dispute regarding whether Petitioner has demonstrated a reasonable likelihood of prevailing.” slip op. at 8

    • Obviousness (§103) › Analogous artAnalogous artDecided for petitioner

      “Weighing the parties’ arguments and evidence, we find Petitioner’s arguments and evidence sufficient at this stage to demonstrate a reasonable likelihood of prevailing. Pet. 8–17, 30–49. For example, regarding whether of Porter’s disclosure to the problem faced by inventor of the ’090 patent. Pet. 8; Ex. 1007 ¶¶ 98–108, 125–127, 144–164. The ’090 patent illustrates that its inventor faced the problem of selecting desirable materials for an aligner, including selecting a desirable material for an aligner’s hard layer. Ex. 1001, 5:44–59. Petitioner and Dr. Osswald provide significant evidence and reasoning tending to show that Porter’s discussion of Tritan logically would have commended itself to the attention of an inventor facing the problem of selecting an aligner hard layer. Pet. 8 (citing Ex. 1007 ¶¶ 98–108, 125–127, 144–164). For example, Dr. Osswald explains that “because Tritan copolyesters are BPA-free, Rafih specifically discloses Tritan EX401 as an exemplary material” for its oral appliance. Id. ¶ 99 (citing Ex. 1104, 5:4–64, claims 2, 9, 10). In view of this, Dr. Osswald testifies that “Rafih would inform a [person of ordinary skill in the art] that Porter’s guidance regarding replacing polycarbonate with Tritan applies to dental appliances.” Ex. 1007 ¶ 146. At this stage, weighing Petitioner’s evidence against Patent Owner’s contrary attorney argument that Porter focuses on dishware, we determine Petitioner has shown sufficiently that Porter is analogous art. Pet. 8; Ex. 1007 ¶¶ 98–108, 125–127, 144–164; Prelim. Resp. 1, 9–10, 18–21.” slip op. at 11

    Claim construction§ 103 obviousnesscites Phillips
    Patents in suitUS 11,648,090
  • PTAB · Nov 6, 2025 · IPR2025-00819 · APJ Kristina M Kalan · IPR · Institution

    The Board instituted IPR on all challenged claims based on both obviousness grounds, finding a reasonable likelihood of success on at least one claim.

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

      “that Petitioner has demonstrated a reasonable likelihood of showing that a person of ordinary skill in the art would have been motivated to combine the teachings of Tadros, Kalili, and Texin 990R to meet the limitations of the claims challenged under this ground.” slip op. at 14

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “would have had at least a four-year undergraduate degree in materials science, mechanical engineering, chemical engineering, or a related field and at least two years of experience in the field of polymer science, combined with at least two years of experience in the field of design, manufacture, and processing of thermoformable polymer sheets for use in various applications, such as in orthodontic and dental appliances. Additional education could substitute for professional experience and vice versa. Pet. 18–19 (citing Ex. 1007 ¶¶ 13–15). At this stage, Patent Owner does not dispute Petitioner’s proposal or offer an alternative proposal. See generally Prelim. Resp. Because Petitioner’s proposed level of ordinary skill in the art appears to be consistent with the cited prior art and is undisputed on this record, we adopt it for purposes of this Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level).” slip op. at 8

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

      “Only claim terms in controversy need be construed. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”). For purposes of this Decision, we determine that no claim term requires express construction.” slip op. at 9

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

      “that Petitioner has demonstrated a reasonable likelihood of showing that a person of ordinary skill in the art would have been motivated to combine the teachings of Tadros, Kalili, and Texin 990R to meet the limitations of the claims challenged under this ground. We disagree that Petitioner fails to meet its burden as to the motivation to combine arguments. Petitioner persuasively maps the limitations of the challenged claims to portions of the references relied upon. Pet. 28–38 (claim 1), 38–51. Petitioner also, on this record, provides adequate statements of motivation to combine with a reasonable expectation of success. See, e.g., id. at 34–36 (citing Ex. 1007 ¶¶ 31, 39–42, 147–151, 174–176). The Petition’s reliance on supporting testimony and related corroborating evidence to support the combination does not amount to impermissible hindsight, as that testimony takes into account “knowledge which was within the level of ordinary skill in the art at the time the claimed invention was made and does not include knowledge gleaned only from applicant’s disclosure.” In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971). Without further clarification or support from Patent Owner, and in the absence of testimony to support the assertion that a POSITA would not have combined the cited references in the manner proposed with a reasonable expectation of success, we are unpersuaded by Patent Owner’s arguments in this regard.” slip op. at 14

    Claim construction§ 103 obviousnesscites KSR
    Patents in suitUS 11,154,384
  • PTAB · Nov 6, 2025 · IPR2025-00818 · APJ Kristina M Kalan · IPR · Institution

    The Board instituted IPR on all challenged claims 1–22 based on all three asserted obviousness grounds.

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

      “We have authority under 35 U.S.C. § 314(a), which provides that 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.” After considering the briefing and cited evidence of record, we institute inter partes review because we find that Petitioner establishes a reasonable likelihood that it will prevail with respect to at least one of the claims challenged in the Petition.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “understanding of a person of ordinary skill in the art at the time the invention was made. See Graham, 383 U.S. at 17–18. Petitioner proposes that a person of ordinary skill in the art (sometimes referred to herein as a “POSITA”) would have had at least a four-year undergraduate degree in materials science, mechanical engineering, chemical engineering, or a related field and at least two years of experience in the field of polymer science, combined with at least two years of experience in the field of design, manufacture, and processing of thermoformable polymer sheets for use in various applications, such as in orthodontic and dental appliances. Additional education could substitute for professional experience and vice versa. Pet. 18 (citing Ex. 1007 ¶¶ 13–15). At this stage, Patent Owner does not dispute Petitioner’s proposal or offer an alternative proposal. See generally Prelim. Resp. Because Petitioner’s proposed level of ordinary skill in the art appears to be consistent with the cited prior art and is undisputed on this record, we adopt it for purposes of this Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level).” slip op. at 8

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

      “Petitioner argues that no terms require construction, but that “Petitioner applies the prior art consistent with Patent Owner’s assertions in its Infringement Contentions (EX1014, 6-20.).” Pet. 26. Patent Owner does not propose any express claim constructions. Prelim. Resp. 5. Nor does Patent Owner allege that any of Petitioner’s claim interpretations contradict Petitioner’s position in the related district court litigation. Id. Only claim terms in controversy need be construed. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”). For purposes of this Decision, we determine that no claim term requires express construction.” slip op. at 9

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

      “that Petitioner has demonstrated a reasonable likelihood of showing that a person of ordinary skill in the art would have been motivated to combine the teachings of Tadros, Kalili, and Texin 990R to meet the limitations of the claims challenged under this ground. We disagree that Petitioner fails to meet its burden as to the motivation to combine arguments. Petitioner persuasively maps the limitations of the challenged claims to portions of the references relied upon. Pet. 27–36 (claim 1), 36–46. Petitioner also, on this record, provides adequate statements of motivation to combine with a reasonable expectation of success. See, e.g., id. at 32–35 (citing Ex. 1007 ¶¶ 31, 39–41, 57–87, 146–150, 171–172). The Petition’s reliance on supporting testimony and related corroborating evidence to support the combination does not amount to impermissible hindsight, as that testimony takes into account “knowledge which was within the level of ordinary skill in the art at the time the claimed invention was made and does not include knowledge gleaned only from applicant’s disclosure.” In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971). Without further clarification or support from Patent Owner, and in the absence of testimony to support the assertion that a POSITA would not have combined the cited references in the manner proposed with a reasonable expectation of success, we are unpersuaded by Patent Owner’s arguments in this regard. We also disagree with Patent Owner’s arguments about “adhesive lamination” using “tie layers” at this point in the proceeding. Prelim. Resp. 15–18. On this record, we are persuaded that Petitioner has adequately supported its arguments that one of ordinary skill in the art would have been motivated to use adhesive lamination to achieve the proposed combination. See, e.g., Pet. 33–35; Ex. 1007 ¶¶ 39–42, 120, 45, 51, 116, 120. Petitioner relies on Kalili as disclosing a hard layer suitable for combination with Tadros’s soft layers (Pet. 32), and more particularly, doing so in the context of a laminated multilayer aligner (Reply 4). To create the laminated multilayer aligner proposed, Petitioner’s suggested use of a particular type of well-known lamination, i.e. adhesive lamination, is sufficiently developed and supported in the Petition. Pet. 32–35. Here, Patent Owner recognizes that Kalili teaches lamination, but suggests that it does not specifically teach using adhesive lamination. Prelim. Sur-reply 5. We note, however, that the parties have identified limited types of known lamination for aligners: coextrusion, extrusion lamination, and adhesive lamination. Prelim Sur-reply 4; Pet. 14–15 n.3, 33. In KSR, the Supreme Court explained that when “there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp.” KSR, 550 U.S. at 421. “If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.” Id. Having reviewed Petitioner’s proffered arguments as to Tadros, Kalili, and Texin 990R, including motivation to combine the references asserted in this ground, with a reasonable expectation of success, we are persuaded on this record that Petitioner has met its burden for institution with respect to Ground 1.” slip op. at 14

    Claim construction§ 103 obviousnesscites KSR
    Patents in suitUS 10,973,613
  • PTAB · Nov 3, 2025 · IPR2025-00799 · APJ Sheridan K Snedden · IPR · Institution

    The Board instituted IPR on claims 1–21, finding a reasonable likelihood that claims 1–6, 16, 18, and 21 are anticipated by Liu.

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

      “To institute an inter partes review, we must determine that the information presented in the Petition shows “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). The Supreme Court has held that a decision to institute under 35 U.S.C. § 314 may not institute on less than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). After considering the information presented in the Petition and Preliminary Response, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving that at least 1 of the challenged claims of the ’151 patent is unpatentable.” slip op. at 2

    • PTAB / AIA Trials › §315(e) estoppelNot reached

      “On the current record, we tend to agree with Patent Owner that the issues presented in this proceeding concern Liu’s alleged inherency and the Form I or XRPD limitations recited in the challenged claims, which are obviousness grounds asserted in PGR2023-00043. Prelim. Resp. 35. That said, the parties are invited to address the issue of whether collateral estoppel applies in this proceeding based on the Final Written Decision of PGR2023- 00043 during trial. Regardless of whether collateral estoppel applies, however, we determine for the reasons below that Petitioner shows a reasonable likelihood of prevailing in its challenge that at least 1 of the challenged claims of the ’151 patent is unpatentable.” slip op. at 3

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

      “Petitioner states that “all terms should be given their plain and ordinary meaning.” Pet. 10. Patent Owner does not propose construction of any terms. See generally Prelim. Resp. Having considered the parties’ positions and evidence of record, we determine that no express construction of any claim term is necessary to determine whether to institute inter partes review. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e 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 8

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “H. Level of Ordinary Skill in the Art Petitioner asserts that a person of ordinary skill in the art (“POSA”) would be “someone with a graduate degree in organic chemistry, material science, medicinal chemistry, pharmaceutical chemistry, or a related field, and four to six years of experience in the synthesis, purification, analysis, design, and/or formulation of pharmaceutical compounds and derivatives.” Pet. 9. Petitioner also asserts that a person of ordinary skill in the art “would have worked with a team of professionals with training in related disciplines, such as pharmacology, pharmacokinetics, formulation, drug discovery Patent Owner does not dispute Petitioner’s definition of a person of ordinary skill in the art. See generally Prelim. Resp. We adopt Petitioner’s definition as it is consistent with the level of ordinary skill in the art as reflected by the prior art in this proceeding. 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 level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). To the extent the parties dispute the level of ordinary skill and its impact on the analysis of the challenged claims, we encourage the parties to address this issue further during trial.” slip op. at 8

    Claim construction§ 102 anticipation
    Patents in suitUS 11,261,151
  • PTAB · Aug 13, 2025 · IPR2025-00147 · APJ Linda E Horner · IPR · Institution

    The Board instituted inter partes review of claims 1–6 and 8–20 after finding a reasonable likelihood that Samsung would prove at least one challenged claim unpatentable.

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

      “Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless the information presented in the petition and the preliminary response shows “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Upon consideration of the Petition and the Preliminary Response, and for the reasons explained below, we determine that Petitioner has shown a reasonable likelihood that it would prevail with respect to at least one of the challenged claims. Thus, we grant the Petition and institute an inter partes review of claims 1‒6 and 8‒20 of the ’124 patent.” slip op. at 2

    • Skill levelSkill level board ownDecided for petitioner

      “At this stage of the proceeding, there is no dispute about the level of ordinary skill in the art.7 Based on the testimony of Dr. Anthony, we determine that a person of ordinary skill in the art would have had at least a four-year degree in electrical engineering, mechanical engineering, biomedical engineering, optical engineering, or related field of study, or equivalent experience, and at least two years’ experience in academia or industry studying or developing physiological monitoring devices such as non-invasive biosensors. A person of ordinary skill in the art would have also been familiar with, for example, sensor system design, including inertial and other motion sensor system design, signal processing, and human-machine interfaces. A higher level of education or skill can substitute for less experience, and vice versa. Ex. 1002 ¶ 29. We determine that the level of ordinary skill in the art adopted above is consistent with the level of technical understanding and competence reflected in the ’124 patent Specification and the asserted prior art references, based on our review of the limited record.” slip op. at 9

    • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notNot reached

      “We need not reach the issue of whether the preamble is limiting for purposes of determining institution. Even were we to agree with Patent Owner that the preamble is limiting and the claims are limited to a fingerworn ring, at this stage Petitioner has demonstrated that the cited art teaches or suggests such a limitation. That is, Petitioner relies on the fingerring of Schroder for the claimed form factor of a “wearable computing device configured to be worn around a finger of a wearer.” Pet. 22 (Ground 1), 45 (Ground 2, relying on Yuen for adding the functionality of light sources with a photodetector, temperature sensors, and varying the sampling frequency of sensor data acquisition), 56 (Ground 3). Further, to the extent Petitioner contends that Yuen’s toe band or earring is structurally and functionally equivalent to a finger-ring (Pet. 45, 57), Patent Owner has not, at this stage of the proceeding, structurally distinguished a device configured to worn around a finger from a toe band or earring. For instance, Patent Owner has not explained how a device to be worn around a finger differs in size, configuration, or design from a toe band or earring. And the ’124 patent recognizes that “a human being’s finger can come in various different sizes and so should the [wearable computing device].” Ex. 1001, 12:64‒65. For instance, challenged dependent claim 10 recites that the width of the external housing of the wearable computing device is within a range of 3 mm to 8 mm and a thickness of the device is within a range of 1.5 to 3 mm. Id. at 35:8‒12. Should Patent Owner pursue this argument during the proceeding, the record would benefit from further development on the structural similarities and dissimilarities between a fingerworn ring and a toe band.” slip op. at 11

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

      “After considering the parties’ arguments and evidence, we determine that Petitioner’s showing of reasons to combine Mestas and Schröder is sufficient for purposes of granting institution of an inter partes review. Although general similarities between the references are usually not by themselves sufficient to show a reason to combine particular teachings, Petitioner here also provides more particularized contentions, such as “[i]mplementing Mestas’s device in Schröder’s ‘finger-ring’ form factor would ensure a tighter fit than a device worn, e.g., on the user’s arm or wrist, reducing motion artifacts, providing better shielding against ambient light, and permitting higher quality reading from device sensors (e.g., accelerometer, heart rate, temperature)” and that Mestas’s concern with “slippage around a user’s wrist or other body part” would have motivated a person of ordinary skill in the art “to consider placing the device on the finger, as in Schröder, to improve traction and prevent slippage.” Pet. 19‒20 (citing Ex. 1002 ¶ 169; Ex. 1010 ¶ 152). These reasons are sufficient to present a reasonable likelihood of prevailing as to at least one challenged claim based on the proposed combination of Mestas and Schroder for purposes of institution. Patent Owner will have an opportunity to further address Petitioner’s reasoning during the proceeding.” slip op. at 21

    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 11,188,124
  • PTAB · Jul 30, 2025 · IPR2025-00246 · APJ Cynthia M Hardman · IPR · Institution

    The Board instituted IPR on all asserted grounds against claims 15–29, finding a reasonable likelihood of success on the Toge–Kumar and Toge–Kumar–Norman obviousness grounds.

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

      “to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). Petitioner ultimately bears the burden of persuasion to prove unpatentability of each challenged claim by a preponderance of the evidence. 35 U.S.C. § 316(e). This burden never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). The Board may authorize an inter partes review if we determine that the information presented in the briefing of record shows a reasonable likelihood that Petitioner will prevail with respect to at least one of the claims challenged in the petition. 35 U.S.C. § 314(a).” slip op. at 7

    • Skill levelSkill level board ownDecided for petitioner

      “understanding of a person of ordinary skill in the art at the time the invention was made.9 See Graham, 383 U.S. at 17–18. At this stage, the parties agree that a person of ordinary skill in the art (sometimes referred to herein as “POSITA”) would have had: at least a bachelor’s degree in mechanical engineering, electrical engineering, computer science, biomedical engineering, or a similar technical field, with at least two years of relevant product design experience working with diagnostic sensor systems and network data systems, such as networked PAP machines. Additional experience could substitute for less education, and additional education could likewise substitute for less experience.” slip op. at 8

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

      “We find it unnecessary to construe any claim term to decide whether Petitioner satisfies the “reasonable likelihood” standard for instituting trial. 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))). Any final written decision entered in this case may include express claim constructions, or may include discussion of claim scope that differs from that provided in our analysis below. Any final claim constructions will be based on the full trial record.” slip op. at 9

    • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Motivation foundReasonable expectation foundInstituted

      “At this stage, Petitioner has the better argument. Toge teaches that control unit 250 analyzes collected data (e.g., the flow rate) and calculates tidal volume. Ex. 1044 (Toge) ¶¶ 34–38. On this record, we agree with Petitioner that the calculated tidal volume is “a quantified level of severity data based on the subject’s sleep apnea symptoms during the therapy” because it represents, e.g., the “level of airway obstruction the patient experiences during the sleep apnea treatment using the PAP device.” Pet. 15. On this record, Patent Owner’s assertion that the tidal volume is a “breathing metric” instead of “a quantified level of severity data” is unavailing in view of Toge’s teaching that control unit 250 calculates the tidal volume, and its teaching that the tidal volume is used to assess the patient’s condition and determine whether system adjustments are needed. See id. at 15–16; Ex. 1044 (Toge) ¶ 39; Ex. 1003 (Kirkness Decl.) ¶ 157. In other words, on this record, the calculated tidal volume indicates severity because it is used to adjust the PAP system, e.g., in the case of decreasing tidal volume, a medical professional can change the airflow settings “to counter/treat the more severe level of airway obstruction observed from the decreasing tidal volume.” Ex. 1003 (Kirkness Decl.) ¶ 158.” slip op. at 20

    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,857,333
  • PTAB · Jun 13, 2025 · IPR2025-00160 · APJ Sheridan K Snedden · IPR · Institution

    The Board instituted IPR on claims 1–5, 7, 8, 10–13, 15–18, and 20–31 because ResMed showed a reasonable likelihood of proving at least one challenged claim obvious.

    RulingsInstitution decision
    • Other 314aInstitution denied discretionary otherDenied

      “We are not persuaded by these arguments. We are aware of no regulation, rule, case law, or Office guidance that prohibits a party from filing both an ex parte reexamination and an inter partes review, or deems doing so “an abuse of the patent system” or a due process violation. Prelim. Resp. 7–8. Indeed, the Office has previously permitted parallel reexaminations and inter partes reviews, even when filed by the same party. See, e.g., CBS Interactive et al. v. Helferich Patent Licensing, IPR2013- 00033, Paper 15, 2 (PTAB Nov. 6, 2012) (“four of the five Petitioners [in the inter partes] are also the third-party requesters who filed the request for reexamination”); Arctic Cat, Inc. v. Polaris Indus. Inc., IPR2015-01781, Paper 78, 2 (PTAB Sept. 25, 2018) (denying patent owner’s motion to stay or terminate ex parte reexamination 90/013,999, which was filed by same petitioner in the related inter partes review); Emerson Electric Co. v. Sipco, LLC, IPR2017-00359, Paper 62, 5, 19 (PTAB Mar. 21, 2019) (declining to terminate two ex parte reexaminations filed by a party who previously filed an inter partes review on the same patent). The Office’s April 2019 Notice Regarding Options for Amendments by Patent Owner Through Reissue or Reexamination During a Pending AIA Trial Proceeding provides information as to how the Office may handle parallel reexamination and AIA proceedings involving the same patent. See 84 Fed. Reg. 16,654, 16656–58 (Apr. 22, 2019). The existence of this Notice indicates that there is nothing per se improper about parallel ex parte reexaminations and inter partes reviews. Accordingly, on this record, we are not persuaded to discretionarily deny this Petition based on” slip op. at 10

    • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied fintivDenied

      “We find that although the parties engaged in some discovery and briefing in the Ohio case, the bulk of the work remains, including the completion of fact discovery, expert discovery, motion practice, trial preparation, and trial. Additionally, prior to the stay, the district court had not issued orders related to claim construction or the validity of the ’680 patent. Accordingly, the relatively minimal investment in the Ohio case weighs against exercising discretion to deny institution. Fintiv, Paper 11, 10.” slip op. at 14

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

      “A patent claim is unpatentable for obviousness if the differences between the claimed subject matter and the prior art are such that the subject matter, as a whole, would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). In Graham v. John Deere Co. of Kan. City, 383 U.S. 1 (1966), the Supreme Court set out a framework for assessing obviousness that requires consideration of four factors: (1) the “level of ordinary skill in the pertinent art,” (2) the “scope and content of the prior art,” (3) the “differences between the prior art and the claims at issue,” and (4) “secondary considerations” of nonobviousness such as “commercial success, long felt but unsolved needs, determination requires finding a reason to combine accompanied by a reasonable expectation of achieving what is claimed in the challenged patent. See Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367 (Fed. Cir. 2016). “[A]ny need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.” KSR, 550 U.S. at 419–20. We analyze the asserted grounds of unpatentability in accordance with these principles to determine whether Petitioner has met its burden to establish a reasonable likelihood of success at trial.” slip op. at 20

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

      “On this record, these arguments are unavailing. “[A] given course of action often has simultaneous advantages and disadvantages, and this does not necessarily obviate a motivation to combine.” Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006). Thus, even if Patent Owner is correct that the proposed combination would no longer have the ability to push information directly to physician-side client devices, or would have duplicative storage, this does not necessarily obviate Petitioner’s proffered motivations to combine, which we find sufficient for purposes of institution.” slip op. at 36

    Claim construction§ 103 obviousnessDiscretionary denialcites KSR · Graham
    Patents in suitUS 11,786,680
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