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  • PTAB · Sep 9, 2025 · PGR2025-00023 · APJ Michael J Fitzpatrick · PGR · Institution

    Instituted PGR on claims 1–9 because the Board found it more likely than not that at least one challenged claim is unpatentable over the ’629 publication.

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

      “Institution of a post-grant review requires that “the information presented in the petition filed under section 321, 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” or that “the petition raises a novel or unsettled legal question that is important to other patents or patent applications.” 35 U.S.C. § 324(a)–(b). 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 it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable. Accordingly, we grant the Petition.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “III. LEVEL OF ORDINARY SKILL IN THE ART Petitioner contends a person of ordinary skill in the art (“POSITA”) would have a Ph.D. degree in biological, chemical or biochemical engineering, molecular biology, or biochemistry and at least two years of experience in the field of utilizing or assessing horseshoe crab zymogen proteins (lysate, purified native and/or recombinantly produced) for endotoxin detection and quantitation. More education could substitute for experience to a certain extent, and vice versa. Pet. 22 (citing Ex. 1003 ¶¶48–49). Patent Owner does not dispute Petitioner’s description of a POSITA in its Preliminary Response. Prelim. Resp. 10. 1 In addition to other changes to Title 35, the AIA introduced amendments to 35 U.S.C. § 102. Because Patent Owner concedes that the ’725 application “contains, or contained at any time, a claim to a claimed invention that has an effective filing date on or after March 16, 2013” (Ex. 1022), the AIA version of § 102 applies to the ’109 patent. AIA § 3(n)(1)(B); Ex. 1001, 1:11–14 (claiming priority to the ’725 application). 2 US 2019/0241629 A1, published August 8, 2019 (“the ’629 publication” (Ex. 1015)). At this stage, we find Petitioner’s description of the level of ordinary skill in the art sufficiently supported by the record and apply it for purposes of this decision.” slip op. at 9

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

      “Neither party proposes an express construction of any claim term. See Pet. 22–23; Prelim. Resp. 10. We determine that no express claim construction is necessary based on the present record.” slip op. at 10

    • Disclosure Requirements (§112) › Written description (Ariad)Not shown unpatentable

      “To show that the claims of the ’109 patent are unpatentable for lack of written description, Petitioner would have needed to show that the specification as filed (i.e., the ’420 application) fails to reasonably convey to those skilled in the art that Patent Owner had possession of the claimed subject matter as of the July 3, 2023, filing date. Petitioner did not. Pet. 23– 24. Nor does Petitioner’s declarant offer testimony that could support such a showing. See Ex. 1003 ¶50 (“I have been asked to provide my opinions as to the state of the art in this field for purposes of determining what the inventors disclosed as their invention as of December 10, 2013.”), ¶51 (“Whenever I offer an opinion in this declaration about the knowledge of a POSA, the manner in which a POSA would have understood the claims of the ’109 patent or its description, the manner in which a POSA would have understood the prior art, or what a POSA would have been led to do based on the prior art, I am referencing the December 10, 2013 timeframe.”). Although the ’420 application is essentially identical to the ’767 application, the person of ordinary skill in 2013 is not the same as in 2023. See Ariad, 598 F.3d at 1351 (“[T]he [written description] test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.” (emphasis added)). Thus, the information presented in the Petition, which is limited to the perspective of a 2013 POSITA, does not demonstrate that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable for lack of written description.” slip op. at 12

    Claim construction§ 102 anticipation§ 112 disclosure
    Patents in suitUS 11,959,109
  • PTAB · Sep 9, 2025 · IPR2025-00440 · APJ Tawen Chang · IPR · Institution

    The Board instituted IPR of claim 21 on both asserted § 103 grounds, finding a reasonable likelihood that claim 21 is obvious over Mizumura with the ’498 PCT and over Mizumura with McClymont.

    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 an 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.” For the reasons discussed below, we determine Petitioner has demonstrated a reasonable likelihood that the challenged claim of the ’318 patent is unpatentable. Accordingly, we institute an inter partes review of the challenged claim on each of the Grounds raised in the Petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018).” slip op. at 2

    • Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateOther

      “Nevertheless, we determine that the contrary evidence Petitioner has cited suffices to establish a reasonable likelihood of success at this preliminary stage of the proceeding. In this regard, we also note Dr. Jain’s testimony — currently unrebutted — that an ordinarily skilled artisan would have known, based on Tokunaga’s sequence comparisons of Factor C proteins, that “certain sequence differences between [Limulus polyphemus] and Tachypleus tridentatus were non-conservative (i.e., potentially giving rise to changes in function in terms of enzymatic activity of Factor C).” Ex. 1002 ¶ 94 (citing Ex. 1022, 157). We likewise note Dr. Jain’s testimony that such artisan would have recognized Tokunaga’s conclusion, regarding “immunological and biochemical properties” of Factor C proteins of the two different horseshoe crab species, to be “based on only gross biophysical-biochemical properties” that are not “granular enough” to predict functional properties such as residual activity in presence of specific ions. Ex. 1002 ¶ 100.” slip op. at 22

    • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledOther

      “submitted in a different proceeding and in a different forum, and our rules contemplate objections to admissibility only after institution. See 37 C.F.R. § 42.64(b)(1) (“Any objection to evidence submitted during a preliminary proceeding must be filed within ten business days of the institution of the trial.”); also compare Fed. R. Evid. 801(c) (defining hearsay as a statement, not made at the current trial or hearing, “offer[ed] in evidence to prove the truth of the matter asserted”), with Fed. R. Evid. 801(d)(2) (excluding from hearsay statement offered against an opposing party where statement was made by “a person whom the party authorized to make a statement on the subject” or by a “party’s agent or employee on a matter within the scope of that relationship and while it existed”). Nevertheless, as discussed above, Petitioner has provided contrary evidence, including statements from Patent Owner’s patent application, suggesting that, “due to the various differences and diversity of biomolecules depending on the genus and species of the horseshoe crab,” it had not been possible “to accurately determine the full-length sequence structure, expression, and function of [Limulus] proteins and genes using conventional methods” more than 20 years after complete gene and amino sequences from two Tachypleus horseshoe crab species had been reported. Pet. 35 (citing, e.g., Ex. 1005 ¶¶ 12–17). Thus, even if we were to take the Frohman Declaration into account, we find that Petitioner has established a reasonable likelihood 28 of success that the ’767 application disclosures did not enable an ordinarily skilled artisan to make and use the invention of the challenged claim without undue experimentation. Furthermore, assuming that the disclosures in ’767 application would have enabled an ordinarily skilled artisan to express recombinant Limulus polyphemus Factor C protein in HEK293, we find Petitioner has established, sufficient for purposes of institution, that the disclosures do not enable an ordinarily skilled artisan to make such a protein exhibiting the “full scope” of the claimed residual activity, without undue experimentation. Patent Owner cites to disclosures in the ’767 application that (1) describe how to produce recombinant Factor C in HEK293 cells and measure residual activity, (2) suggest “Factor C expressed in mammalian cells can have low susceptibility to activity inhibition by ions,” and (3) provide examples where residual activity met the required minimum. Prelim. Resp. 26–27, 32–34. Nevertheless, whether an ordinarily skilled artisan would have been able to make, based on these disclosures and without undue experimentation, a recombinant Factor C protein having residual activity encompassed by claim 21 but higher — even significantly higher — than that achieved in the example, is a fact intensive issue that would benefit from further development during trial.15 See, e.g., In re” slip op. at 28

    • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date, deniedOther

      “the proceeding, and for the reasons set forth below, we are persuaded that Petitioner has shown sufficiently, for purposes of institution, that the ’767 application does not provide adequate written description support for claim 21 of the ’318 patent and that, accordingly, Mizumura, the ’498 PCT, and McClymont qualify as prior art to the challenged claim.” slip op. at 19

    § 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
    Patents in suitUS 11,236,318
  • Lifevac, LLC v. Dcstar Inc.Institution denied
    PTAB · Sep 8, 2025 · IPR2025-00454 · APJ Cynthia M Hardman · IPR · Institution

    The Board denied institution on claims 1–17 because Petitioner did not show a reasonable likelihood that Zhongnan qualifies as prior art under the § 102(b)(1)(B) exception.

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

      “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 inter partes review if we determine that the information presented in the Petition and Patent Owner’s Preliminary Response 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 8

    • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportReference not prior artDecided for patent owner

      “provides that a disclosure which would otherwise qualify as prior art under AIA 35 U.S.C. 102(a)(1) (patent, printed publication, public use, sale, or other means of public availability) is excepted as prior art if: (1) the disclosure was made one year or less before the effective filing date of the claimed invention; and (2) the subject matter disclosed had been previously publicly disclosed by the inventor, a joint inventor, or another who obtained the subject matter directly or indirectly from the inventor or joint inventor. MPEP § 2153.02 (9th ed. rev. 01.2024 Nov. 2024); see also Sanho, 108 F.4th at 1381. As to point (1), there is no dispute that Zhongnan was published one year or less before the effective filing date of the challenged claims. See, e.g., Ex. 1005, code (43); Pet. 11, 20; Prelim. Resp. 9–10. Thus, we focus on point (2), which requires that IDEAR be previously publicly disclosed by the inventor, and that Zhongnan and IDEAR disclose the same subject matter.” slip op. at 10

    • BurdenDecided for patent owner

      “Our rules require that in determining whether to institute inter partes review, we “take into account a patent owner preliminary response where such a response is filed, including any testimonial evidence.” 37 C.F.R. § 42.108(c) (emphasis added); Prelim. Sur-reply 3. As Patent Owner correctly notes, “the Board routinely weighs declaratory testimony at the institution[] stage and virtually always makes institution decisions without the benefit of cross-examination.” Prelim. Resp. 19–20 (emphasis omitted) (citing LG Elecs. Inc. v. Wi-LAN Inc., IPR2018-00704, Paper 14 at 13–14 (PTAB 2018); Freebit AS v. Bose Corp., IPR2017-01308, Paper 8 at 28 (PTAB 2017)). For example, in LG Electronics and Freebit, the Board denied institution, finding that the patent owner had provided sufficient evidence to antedate the petitioners’ proffered prior art references. See LG Elecs., IPR2018-00704, Paper 14 at 7; Freebit, IPR2017-01308, Paper 8 at 25, 34.10” slip op. at 23

    § 102 anticipation
    Patents in suitUS 11,478,575
  • PTAB · Aug 25, 2025 · IPR2025-00631 · APJ Kevin W Cherry · IPR · Institution

    The Board instituted IPR on claims 1–3, 5, 7–9, 11–13, and 15–22 on all five asserted § 103 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

      “institute an inter partes review. The standard for instituting an inter partes review is set forth in 35 U.S.C. § 314(a), which provides that an 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.” The Supreme Court has held that the Board, in a decision to institute under 35 U.S.C. § 314(b), may not institute review on less than all claims challenged in the petition. SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1355–56 (2018). Moreover, in accordance with our rules, “[w]hen 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) (2020); see also PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition”). Applying those standards, and upon considering the Petition, the Preliminary Response, and the evidence of record, we determine the information presented shows a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of at least one of the challenged claims of the ’027 patent. Accordingly, we institute an inter partes review of all challenged claims (i.e., 1–3, 5, 7–9, 11–13, and 15–22) of the ’027 patent, based on the grounds asserted in the Petition.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner contends that a person of ordinary skill in the art would have “possessed an undergraduate degree in chemistry, polymers, materials science, chemical engineering (or related field) and one to two years of experience with constructing and manufacturing tires, tire patches, tire decals/stickers and/or the like.” Pet. 8 (citing Ex. 1003 ¶¶ 6–11). According to Petitioner, “Additional education could compensate for less practical experience. Conversely, additional practical experience could compensate for less education.” Id. Patent Owner does not provide an alternate definition, but, “Patent Owner does not acquiesce to, and reserves the right to address, [Petitioner’s] definition of a POSA.” Prelim. Resp. 6 n.6. Petitioner’s proposed definition appears to be consistent with the disclosure of the ’027 patent, and we adopt it for purposes of this Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that the prior art itself may “reflect[] an appropriate level” of ordinary skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 8

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

      “Having considered the record, we determine that no express claim construction is necessary for any claim terms. 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)).” slip op. at 10

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

      “We disagree with Patent Owner’s contentions that these disclosures indicate that Wilson’s patch would not meet the construction of “barrier material composition.” None of these disclosures even suggests that the base of Wilson’s patch is rigid as Patent Owner suggests. To begin with, the fact that the housing is “more rigid” provides no information about the absolute rigidness of the patch. See Ex. 1009, 9:16–21. As for the disclosure that the patch is contoured (id. at 3:35–67), Patent Owner provides only attorney argument to support its contention that the contour demonstrates that Wilson’s patch must be so rigid that it cannot be meet the claim limitation. In contrast, Petitioner demonstrates that Wilson discloses using the exact same materials described in the challenged patent (see Ex. 1001, 6:33–58 (noting “[e]lastomeric materials useful for forming the intermediate layer 24 include but are not limited to gum rubber, vulcanized natural rubber SBR . . . or comparable materials”); Ex. 1009, 3:49–55 (noting the patch may be constructed from natural rubber (NR), a preferred mixture of chlorobutyl rubber and natural rubber (CR/NR), or a preferred mixture of SBR and natural rubber (SBR/NR)), and provides detailed testimony from its expert to support its contentions (see Ex. 1003 ¶¶ 114–119). On the current record, we find Petitioner’s reasoning and evidence to be persuasive, and find that Petitioner has shown sufficiently that Willson discloses or teaches this limitation.” slip op. at 20

    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 11,124,027
  • PTAB · Aug 11, 2025 · IPR2024-01502 · APJ James A Worth · IPR · Adverse judgment

    The Board granted the joint motion for adverse judgment after Patent Owner disclaimed claims 1–3, 5–11, and 14–17, and terminated the inter partes review.

    RulingsAdverse judgment
    • Adverse judgmentAdverse judgmentGranted

      “Section 42.73 provides that “[a] party may request judgment against itself at any time during a proceeding. Actions construed to be a request for adverse judgment include: (2) Cancellation or disclaimer of a claim such that the party has no remaining claim in the trial.” 37 C.F.R. § 42.73(b)(2). We agree that adverse judgment and termination are appropriate in view of the disclaimer because no challenged claim remains.” slip op. at 2

    None
    Patents in suitUS 9,546,399
  • PTAB · Jul 23, 2025 · IPR2025-00371 · APJ Brian D Range · IPR · Institution

    The Board instituted IPR on claims 1–25 based on all petitioned grounds, finding a reasonable likelihood that POSCO would prevail.

    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 “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.” The following findings of fact and conclusions of law are not final, but are made for the sole purpose of determining whether Petitioner meets the threshold for initiating review. Any final decision shall be based on the full trial record, including any response timely filed by Patent Owner. Any arguments not raised by Patent Owner in a timely-filed response may be deemed waived. For the reasons stated below, we determine that Petitioner has established a reasonable likelihood that it would prevail with respect to at least one claim. We hereby institute an inter partes review as to claims 1–25 of the ’227 patent based upon Petitioner’s asserted grounds of unpatentability.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner contends that a person of ordinary skill in the art (POSITA) “would have had an undergraduate degree in materials science, manufacturing engineering, mechanical engineering, or equivalent knowledge, training, or experience, with two years of experience working in metallurgy.” Pet. 6 (citing Ex. 1003 ¶ 15). For purposes of this Decision, we adopt Petitioner’s proposal as reasonable and consistent with the ’227 patent specification and the prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art).” slip op. at 8

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

      “Petitioner does not propose any claim constructions. Pet. 3. We do not discern a need to construe explicitly any claim language at this juncture because doing so would have no effect on our analyses below of Petitioner’s asserted grounds and will not assist in resolving the present controversy between the parties. 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)).” slip op. at 9

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

      “35 U.S.C. § 103(a) as obvious over Takagi and Cornette, citing the Declaration of Dr. Miles for support. Pet. 1, 6–49 (citing Ex. 1003) (Petitioner’s Ground 1A). a. Claim 1 Petitioner argues that Takagi and Cornette teach or suggest each recitation of claim 1. Pet. 6–31. Petitioner argues, for example, that the preamble of claim 1 is not limiting or, alternatively, imparts no structural distinction from Takagi. Id. at 20–23 (citing, e.g., Ex. 1003 ¶ 48). Petitioner further argues that Takagi and Cornette teach forming or hot stamping to arrive at their products. Id. at 23 (citing, e.g., Ex. 1016 ¶ 36 (Takagi referring to “form[ing]” its products shape); Ex. 1014, 9–11 (Cornette referring to “hot stamping”); Ex. 1003 ¶ 48. Petitioner argues that Takagi teaches a strip of base steel having a first and second side. Id. at 23–24 (citing, e.g., Ex. 1003 ¶ 49; Ex. 1016 ¶¶ 13, 36. Petitioner argues that Takagi teaches a coating that is a “diffusion layer” having five phases as depicted by Takagi Figure 2A and explained by Takagi Table 1 (Takagi Fig. 4). Id. at 24–30 (citing, e.g., Ex. 1003 ¶¶ 50–59; Ex. 1016 ¶ 20, Fig. 2A). Petitioner argues that Takagi alone or as modified by Cornette teaches a coating thickness greater than than 30 µm. Id. at 30–31; Ex. 1014, 9; Ex. 1016 ¶ 35; Ex. 1003 ¶¶ 60–61. Petitioner explains why a person having ordinary skill in the art would have had reason to combine teachings of Takagi and Cornette with a reasonable expectation of success. Pet. 11–20 (citing, e.g., Ex. 1003 ¶¶ 31–47; Ex. 1016 ¶¶ 19–37, 47; Ex. 1014, 9; Ex. 1025, 5:17–20; Ex. 1026, 7; Ex. 1034 ¶ 13; Ex. 1055 ¶¶ 2, 7, 14–15, 18, Fig. 3). Based on our review and consideration of the current record, we determine that the information presented sufficiently supports, for purposes of institution, Petitioner’s assertions that Takagi and Cornette teach or suggest each limitation of claim 1. See Pet. 6–31. We therefore determine Petitioner has met its burden to show a reasonable likelihood it would prevail in demonstrating that claim 1 would have been obvious over Takagi and Cornette.” slip op. at 12

    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,326,227
  • PTAB · Jul 23, 2025 · IPR2025-00370 · APJ Brian D Range · IPR · Institution

    The Board instituted IPR of claims 1–30 on all twelve asserted obviousness grounds, finding a reasonable likelihood that POSCO would prevail.

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

      “unless the information presented in the petition “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.” The following findings of fact and conclusions of law are not final, but are made for the sole purpose of determining whether Petitioner meets the threshold for initiating review. Any final decision shall be based on the full trial record, including any response timely filed by Patent Owner. Any arguments not raised by Patent Owner in a timely-filed response may be deemed waived. For the reasons stated below, we determine that Petitioner has established a reasonable likelihood that it would prevail with respect to at least one claim. We hereby institute an inter partes review as to claims 1–30 of the ’602 patent based upon Petitioner’s asserted grounds of unpatentability.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “For purposes of this Decision, we adopt Petitioner’s proposal as reasonable and consistent with the ’602 patent specification and the prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art).” slip op. at 9

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

      “Petitioner does not propose any claim constructions. Pet. 3. We do not discern a need to construe any claim language at this juncture because doing so would have no effect on our analyses below of Petitioner’s asserted grounds and will not assist in resolving the present controversy between the parties. 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” slip op. at 9

    • BurdenInstituted

      “determine that the information presented sufficiently supports, for purposes of institution, Petitioner’s assertions that Takagi and Cornette teach or suggest each limitation of claim 1. See Pet. 6–33. We therefore determine Petitioner has met its burden to show a reasonable likelihood it would prevail in demonstrating that claim 1 is obvious over Takagi and Cornette.” slip op. at 12

    Claim constructioncites KSR · Graham
    Patents in suitUS 10,961,602
  • PTAB · Jul 16, 2025 · PGR2025-00012 · APJ Debra L Dennett · PGR · Institution

    Instituted PGR on claims 1–3 based on five grounds; the Board found each ground met the institution threshold on the preliminary record.

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

      “We have authority to determine whether to institute a post-grant review under 35 U.S.C. § 324. Institution of a post-grant review is authorized by statute when “the information presented in the petition . . . would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). A post-grant review may also be instituted when “the petition raises a novel or unsettled legal question that is important to other patents or patent applications.” See id. § 324(b). Applying that standard on behalf of the Director (37 C.F.R. § 42.4(a)) and in consideration of the Petition, Preliminary Response, and the evidence of record, we determine that the information presented shows that it is more likely than not that Petitioner would prevail in establishing unpatentability of claims 1–3 of the ’201 patent.” slip op. at 2

    • Skill levelSkill level board ownOther

      “At this stage of the proceedings, neither Petitioner’s nor Patent Owner’s proffered definitions of the level of skill appear appropriate. Petitioner’s proposal requires as little as a bachelor’s degree in organic chemistry and two years of experience as a laboratory technician working on development of molecules with targeted biological activity, and an ambiguous “understanding” of certain processes. Patent Owner’s proposal, other the other hand, requires multiple years of both formal training and actual, practical experience in highly specialized fields that involve detection of optical or radiolabeled compounds and use of molecular imaging techniques such as PET and SPECT. For the purposes of this decision, on the record at this time, we find that a POSA would have had a Ph.D. in chemistry, biochemistry, or a comparable field or an M.D., and at least four years of experience in chemical synthesis of compounds that may be used to target biologically-significant tissues. This definition appears consistent with the level of skill shown in the prior art references of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). The parties will have the opportunity to cross-examine Dr. Martin and Dr. VanBrocklin in this proceeding to develop a full record for us to determine the weight that each expert’s testimony should be given. We invite the parties to further brief the definition of a POSA here, and whether we should discount either experts’ testimony due to lack of qualifications.” slip op. at 8

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Other

      “c) Analysis On the present record, we find that “low molecular weight” is not limited to Patent Owner’s proposed “from about 50 Daltons to about 1,500 Daltons.” The cited evidence relied on in the Pomper Declaration all concerns metabolomics and metabolites, and we find no reason that even a vague definition of metabolites applies to the claimed compounds. See Ex. 1002, ¶ 102. Moreover, the uncontested fact that several of the B moieties alone—without the A moiety or L linker—specifically identified in the ’201 patent fall outside of Patent Owner’s proposed definition is persuasive (see id., ¶ 103), as we normally do not interpret claim terms in a way that excludes examples disclosed in the specification. See, e.g., Verizon Servs. Corp. v. Vonage Holdings Corp., 503 F.3d 1295, 1305 (Fed. Cir. 2007) (rejecting proposed claim interpretation that would exclude disclosed examples in the specification). In addition, the opinion stated in the Pomper Declaration that “the term of ‘low molecular weight’ is well accepted in the chemical arts’” and the declarant “recognize[s] that low molecular weight compounds would have a molecular weight of typically form about 50 Daltons to about 1,500 Daltons” is offered by a co-inventor. We, as factfinder, have discretion to weigh the credibility of expert witnesses and to give each item of evidence such weight as appropriate. See In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”). In this case, we find that the published references on metabolites do not support the opinion. In re Am. Acad. of Sci. Tech Ctr., 367 F.3d at 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”) The Pomper reference (Ex. 1006) also uses the term “low molecular weight”—without further characterization of the term—and is uninformative as to the meaning of the term. See Ex. 2002, ¶ 60; Ex. 1006, ¶ 12. The table giving the molecular weight of a “selection of compounds disclosed by Pomper” (see Ex. 2002, ¶ 62) is not persuasive in defining “low molecular weight,” as it does not explain how those included were “selected” and does not include molecular weights for all of the examples.7 In addition, Patent Owner’s definition does not appear to apply to all claimed compounds.8 7 At least one of the examples (SRV73) not included in the table appears to have a molecular weight well over “about 1,500 Daltons.” 8 See, e.g., claim 113 of Ex. 1006. Patent Owner’s arguments distinguishing “low molecular weight” slip op. at 11

    • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner

      “The ’201 patent defines “alkyl” as “a straight (i.e., unbranched) or branched chain, acyclic or cyclic hydrocarbon group, or combination thereof” “ that has “the number of carbon atoms designated (i.e., C1–C10 means one to ten carbons, including 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10 carbons)” and “[i]n particular embodiments, the term ‘alkyl’ refers to C1-20 inclusive, including 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, and 20 carbons” “unless otherwise stated.” Ex. 1001, 39:44–58. Although substituents at the R1x position in the claims are limited to “C1-6alkyl,” those at position R3x are not. Ex. 1001, Certif. Corr. Patent Owner’s representation that “Jansen I provides ‘the following definitions’ stating that ‘alkyls groups of this invention comprise from 1 to 6 carbon atoms’” is inaccurate. See Prelim. Resp. 19. In fact, Jansen I states: The term “alkyl” by itself or as part of another substituent refers to a fully saturated hydrocarbon of Formula CxH2x+1 wherein x is a number greater than or equal to 1. Generally, alkyl groups of this invention comprise from 1 to 6 carbon atoms. Alkyl groups may be linear or branched and may be substituted as indicated herein. When a subscript is used herein following a carbon atom, the subscript refers to the number of carbon atoms that the named group may contain. Ex. 1007, 22:16–23 (emphasis added). Neither the ’201 patent nor its incorporation by reference of Jansen I would have conveyed to a POSA that the “(CO)alkyl” of the substituent in the R3x position in the claims is intended to comprise from one to six carbon atoms or is limited to any particular length and size. “(C(O)alkyl,” having no number of carbon atoms designated, means” slip op. at 15

    Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham · Nautilus
    Patents in suitUS 11,938,201
  • PTAB · Jul 8, 2025 · IPR2025-00155 · APJ James A Worth · IPR · Institution

    The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1, 3–9, 11–17, or 19 were unpatentable on the asserted obviousness grounds.

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

      “Institution of an inter partes review is authorized by statute when “the information presented in the petition filed under [35 U.S.C. §] 311 and any response filed under [35 U.S.C. §] 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) (2018).1 For the reasons set forth below, we determine that Petitioner has not demonstrated that there is a reasonable likelihood that at least one of claims 1, 3–9, 11–17, and 19 of the ’187 patent is unpatentable based on the grounds set forth in the Petition, and we do not institute an inter partes review.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner asserts that a person of ordinary skill in the art (“POSITA”) would have had an undergraduate degree in mechanical engineering or equivalent coursework, and a year or more of experience in designing, prototyping, and/or manufacturing fluid containers or similar products. Pet. 19 (citing Ex. 1003 ¶ 29). Petitioner asserts that more work experience may substitute for a lower level of education, and vice versa. Id. Patent Owner admittedly sets forth “a similar, though slightly different, level of ordinary skill”: a bachelor’s degree in mechanical engineering or the equivalent coursework and approximately one year of experience with liquid-containing devices, with more work experience substituting for less education and vice versa. Prelim. Resp. 27 (citing Ex.2001 ¶¶ 60–64). Patent Owner discerns no material difference between the definitions provided by the parties for purposes of the Board’s decision on whether to institute this proceeding. Id. For purposes of this decision, we adopt Petitioner’s proposed level of skill as being consistent with the prior art, although our conclusion on whether to institute would be unchanged under either definition.” slip op. at 10

    • Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)§112(f) appliesDecided for petitioner

      “The failure to use the word “means” in a claim element creates a rebuttable presumption that § 112 ¶ 6 does not apply. Williamson v. Citrix Online, 792 F.3d 1339, 1348 (Fed. Cir. 2015) (en banc). The presumption can be overcome and § 112 ¶ 6 will apply if the challenger demonstrates that the claim term fails to “recite[ ] sufficiently definite structure” or else recites “function without reciting sufficient structure for performing that function. “Construing a means-plus-function claim term is a two-step process.” Id. at 1351. “The [tribunal] must first identify the claimed function.” Id. “Then, the [tribunal] must determine what structure, if any, disclosed in the specification corresponds to the claimed function.” Id. There may be multiple claimed functions, each with disclosed corresponding structure. See id. at 1351–52.” slip op. at 14

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

      “We are persuaded by Patent Owner that the term “automatically” in “to automatically disengage the first and second catch structures” means that it is not just the force applied by the user that disengages the first and second catch structures, but also the bias of the mouthpiece that helps to disengage the first and second catch structures. In the first instance, we agree with Patent Owner that the claim itself recites that, upon actuation, the mouthpiece assembly is “release[d]” to “move via its bias from the stowed configuration to the dispensing configuration.” See Ex. 1001, 21:59–64. This meaning is supported by the Specification which states: “In some examples, the mouthpiece assembly is biased toward the dispensing configuration and thus moves automatically under its bias upon release by the user-release mechanism.” Ex. 1001, 1:64–67. We further agree with Patent Owner that the plain and ordinary meaning of “automatic” is that the user operation alone is not responsible for the action. For example, in one dictionary cited by Petitioner, “automatic” is defined as “2: having a self-acting or self-regulating mechanism.” See Ex. 2007, 1.11 The district court construction is consistent therewith. The district court identified two functions, the first of which is the same as that of the ’028 patent, i.e., “Automatically disengaging the first and second catch structures upon actuation of the user release mechanism and thereby releasing the mouthpiece assembly to move via its bias from the stowed configuration to the dispensing configuration.” See Section II.C.1, supra. In discussing that function, the district court states: “While a user may impart force upon user engagement portion 260 to release the mouthpiece, the bias of the mouthpiece towards the dispensing configuration causes the mouthpiece to move automatically, satisfying the requirements of Claim 1.” Ex. 2002, 16. We conclude that the term “automatically” in “adapted to” slip op. at 17

    Claim construction§ 103 obviousnesscites Phillips · Graham
    Patents in suitUS 11,684,187
  • PTAB · Jun 25, 2025 · IPR2024-01280 · APJ Jo-Anne M Kokoski · IPR · Remand

    On remand, the Board denied institution under § 314(a), finding the Fintiv factors favored denial despite declining to deny under § 325(d).

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

      “Other than initials on a lengthy IDS, nothing in the record indicates that the Examiner substantively considered Takeuchi, Kim, Pienemann, or among over 1,000 other references listed on the IDS, which, as noted in the Director Review Decision, “is over 40 times the size of a typical IDS.” Pet. Remand Br. 5–6; DR Dec. 7 n.3 (citing Setting and Adjusting Patent Fees During Fiscal Year 2025, 89 FR 91898 at 91924 (Nov. 20, 2024)); Ex. 1002, 228–284. Petitioner also shows that the applicant did not respond to the Examiner’s request that the applicant specifically point out “any particular reference or portion of a reference in the [IDS] which the examiner should take [sic] pay particular attention to.” Ex. 1002, 174, 295– 302.” slip op. at 13

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

      “Patent Owner is likely correct that the ITC would not have been inclined to grant a stay if one had been requested at the time the Institution Decision issued. Moreover, the ITC conducted a full evidentiary hearing a month after the Institution Decision issued, and the target date for the ITC’s final determination is several months before the projected statutory deadline for the Board’s final written decision. PO Remand Br. 7. Accordingly, we determine that Fintiv factor 1 weighs in favor of discretionary denial. See also Klein Tools, Inc. v. Milwaukee Electric Tool Corp., IPR2024-01400, Paper 22 at 2 (PTAB June 9, 2025) (Acting Director Stewart determining that Fintiv factor 1 weighs in favor of discretionary denial when the ITC investigation is unlikely to be stayed, the ITC already conducted a full evidentiary hearing, and the ITC final determination is expected to issue six months before the statutory deadline for the Board’s final written decision).” slip op. at 19

    Discretionary denialcites Phillips
    Patents in suitUS 11,925,202

Holdings, summaries, rulings, issues, outcomes, winners and claim constructions shown for a decision were generated by a large language model reading the opinion. They are a guide to the decision, not the decision. Confirm every one against the court's own text before relying on it. Outcomes read from the patent owner’s side. Party names are extracted from the decision and are missing on about 900 short Director denials and scans, which carry the trial number instead.