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  • PTAB · Dec 11, 2025 · IPR2025-01025 · APJ Timothy G Majors · IPR · Institution

    The Board instituted IPR on all challenged claims and all asserted grounds, finding a reasonable likelihood that claim 1 is unpatentable over Garrison with Laub and/or Aklog.

    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 it is determined that there is a reasonable likelihood that the petitioner will prevail with respect to at least one of the claims challenged in the petition. For reasons explained below, we conclude that Petitioner shows a reasonable likelihood that it will prevail with respect to at least one of the ’910 patent’s challenged claims. We institute inter partes review on all challenged claims and on all asserted grounds. See SAS Inst. Inc. v. Iancu, 584 U.S. 357, 362–63 (2018); 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”).” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “(“POSA”) “would have had an undergraduate degree in mechanical engineering or a related engineering discipline and 2-4 years of catheter design experience and, where necessary, would have consulted with a physician regarding the methods of treatment.” Pet. 18 (citing Ex. 1003 ¶¶ 35–36).” slip op. at 12

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

      “standard used in a civil action before the courts under 35 U.S.C. § 282(b), including construing claim language in accordance with its ordinary and customary meaning as understood by the POSA, in view of the patent’s specification and considering the patent’s prosecution history. 37 C.F.R. § 42.100(b). We need only construe terms where the parties dispute a term’s meaning and only to the extent needed to resolve the controversy. Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019).” slip op. at 13

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

      “To show unpatentability based on a combination of teachings, “[a]n obviousness determination [also] requires finding both that a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” CRFD Rsch., Inc. v. Matal, 876 F.3d 1330, 1340 (Fed. Cir. 2017) (internal quotation marks omitted).” slip op. at 12

    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,974,910
  • PTAB · Dec 11, 2025 · IPR2025-01021 · APJ Timothy G Majors · IPR · Institution

    The Board instituted IPR on claims 1–12, 14–31, and 33–38 on all asserted grounds, finding a reasonable likelihood of success on at least claim 1.

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

      “its challenge to the claims under Grounds 1A–4A. We have also considered Patent Owner’s counterarguments, which we find unavailing at this stage for reasons explained below. See infra Section III.E.3. Upon considering the parties’ argument and evidence, we find that Petitioner has established that it is reasonably likely to succeed in showing that at least claim 1 would have been obvious under Grounds 1A–4A. Based on the preliminary record, Petitioner persuades us that a POSA would have had reasons for adding a stopcock (or similar flow-control valve) to Laub’s system between the catheter and the cited clot canister and pressure source, as suggested by Garrison. See, e.g., Ex. 1006 ¶¶ 130–134; Ex. 1012, Fig. 1A; Ex. 1006, Fig. 34. Petitioner persuades us that Laub’s system, modified as proposed, would allow a user to close the valve while a pressure source (e.g., a pump) creates a negative pressure and vacuum between the valve and the pressure source, which vacuum may then be applied to a distal portion of the catheter upon opening the valve to facilitate a rapid aspiration of a portion of a PE into the clot canister. Pet. 38–42; Ex. 1003 ¶¶ 48, 103–114.” slip op. at 30

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “(“POSA”) “would have had an undergraduate degree in mechanical engineering or a related engineering discipline and 2-4 years of catheter design experience and, where necessary, would have consulted with a physician regarding the methods of treatment.” Pet. 13 (citing Ex. 1003 ¶ 35). Patent Owner counters that Petitioner’s proposed definition is “insufficient” but does not, in the Preliminary Response, explain why it is “insufficient” or propose a definition of its own. Prelim. Resp. 20 (citing333 Ex. 2005 ¶ 52).14 Instead, in advancing Patent Owner’s counterarguments, “Patent Owner applies Petitioner’s definition.” Id. For this Decision, we apply Petitioner’s POSA definition, which appears to be reasonable and consistent with the prior art.” slip op. at 12

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

      “specification and considering the patent’s prosecution history. 37 C.F.R. § 42.100(b). We need only construe terms where the parties dispute a term’s meaning and only to the extent needed to resolve the controversy. Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019). Petitioner contends that the term “filament” in, for example, dependent claim 11 means at least “one or more threads, lines, cords, ropes, ribbons, flat wires, sheets, or tapes.” Pet. 15. Patent Owner notes its disagreement with Petitioner’s interpretation of the term “filament” in related proceedings (e.g., IPR2025-00289). Prelim. Resp. 20 n.3. But Patent Owner contends that the claim construction issue in related proceedings “is not germane” to Patent Owner’s arguments in the present case and, thus, the Board need not construe that term (or any other term of the ’333 patent’s challenged claims) at this time. We need not, at this stage, further construe the ’333 patent’s claims to address the issues that are presently in dispute.” slip op. at 13

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner

      “pumps, like described in Laub, Aklog, and Garrison would, in the proposed modified systems, generate a vacuum pressure as claimed will be best assessed on a full record at trial. As an initial matter, claim 1 does not recite a “maximum level of aspiration in a rapid fashion.” At most, Patent Owner’s argument (if accepted) may weaken some of Petitioner’s reasoning for modifying the prior art. In any event, we are at this stage unpersuaded that a pump would not, when a fluid control valve is closed, generate a vacuum pressure and operate in the manner claimed. See, e.g., Ex. 1003 ¶¶ 103–105 (testifying that a stopcock and aspiration pump would generate a vacuum and provide for rapid aspiration). Garrison does not disclose that only syringes have such capability, and Garrison teaches, in the same paragraph where the cited alternative aspiration sources may be used in its systems (“active source[s] of aspiration may be an aspiration pump, a regular or locking syringe, a hand-held aspirator, hospital suction, or the like”). Ex. 1006 ¶ 134. Garrison’s disclosure is, thus, not limited to use of syringes or even peristaltic pumps (as allegedly depicted in Figure 34). We also note (as pointed out by Petitioner) that the ’333 patent indicates that both pumps and syringes generate and store negative/vacuum pressure in an aspiration system.18 Ex. 1001, 7:28–41, dependent claim 15 (aspiration source comprises “an electric pump”); Prelim. Reply 5. That a POSA would have understood that both syringes and pumps, like disclosed in Garrison, can generate a vacuum pressure to permit rapid aspiration of clots also finds further evidentiary support in Dr. Turk’s testimony that surgeons have used pumps and syringes for that purpose since the early 2010s. Ex. 1022 ¶ 23. Moreover, although Laub teaches that running a pump continuously at high flow rates can assist with dislodging clots, Petitioner persuades us on the present record that a POSA would see benefit in modifying Laub’s system to also allow for an initial or intermittent rapid burst of vacuum pressure to help remove a clot. Ex. 1003 ¶¶ 106, 109.” slip op. at 33

    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,969,333
  • PTAB · Nov 19, 2025 · PGR2025-00053 · APJ Susan L C Mitchell · PGR · Institution

    The Board instituted PGR on claims 1–3 and 5–15, finding written-description and enablement challenges more likely than not to succeed, but not the obviousness challenge.

    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). Applying that standard on behalf of the Director (37 C.F.R. § 42.4(a)) and in consideration of the Petition and the cited 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 and 5– 15 of the ’773 patent, and therefore, we grant post-grant review for the reasons articulated below.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner’s proposal is sufficiently comprehensive to encompass the level of skill reflected in prior art relevant to the ’773 patent. It is reasonably clear that, in indicating that a POSA would have an advanced degree (like a Pet. 7. We have adjusted the claims challenged to only those that remain in effect following Patent Owner’s disclaimer. See Ex. 2003. 3 US 7,767,429 B2, issued Aug. 3, 2010 (the “’429 patent”; Ex. 1005). 4 Chao et al., Structure of Human Hyaluronidase-1, a Hyaluronan Hydrolyzing Enzyme Involved in Tumor Growth and Angiogenesis, 46 Biochemistry 6911–6920 (2007) (Ex. 1006). Ph.D.) and years of experience in analysis of protein structure, Petitioner is asserting that knowledge of proteins generally is sufficient to understand the types of problems encountered in the art and the prior art solutions to those problems, and the ordinary artisan need not have expertise specifically in hyaluronidases. See Pet. 16–17. Petitioner requires that the POSA would be able to apply key scientific concepts (e.g., biochemistry, recombinant biology, sequence analysis and protein modeling) to enzymes such as hyaluronidases. See id. At this stage of the proceeding and on the record before us now, we apply Petitioner’s proposed POSA level, which 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).” slip op. at 8

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

      “refers to a PH20 polypeptide that contains at least one amino acid modification, such as at least one amino acid replacement as described herein, in its sequence of amino acids compared to a reference unmodified PH20 polypeptide. A modified PH20 polypeptide can have up to 150 amino acid replacements, so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity. Typically, a modified PH20 polypeptide contains 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50 amino acid replacements. It is understood that a modified PH20 polypeptide also can include any one or more other modifications, in addition to at least one amino acid replacement as described herein. Id. at 47:8–22 (emphasis added). On this record, however, we find that the definition of “modified PH20 polypeptide” permits amino acid replacements in the PH20 polypeptide but only “so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.” Ex. 1001, 47:13–15. Indeed, while some of the language in the above paragraph is permissive in nature, i.e.., describing the number of amino acid replacements a modified PH20 polypeptide “can have” or “[t]ypically . . . contains” or the other modifications the polypeptide “can include,” the phrase “so long as” is not. See Ex. 1001, 47:8–22. This distinction demonstrates that hyaluronidase activity is not an optional feature of a non-limiting example, but a requirement of the “modified PH20 polypeptide” defined and claimed in the ’773 patent. See Alynylam Pharms., Inc. v. Moderna, Inc., 138 F.4th 1326, 1333 (Fed. Cir. 2025) (explaining that the “contrast” between “non-limiting terms” and more definitive statements may indicate that the latter is definitional).” slip op. at 13

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

      “We determine that we need not expressly construe any other claim terms for the purpose of deciding whether to institute post-grant review. See 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 14

    Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
    Patents in suitUS 12,195,773
  • PTAB · Nov 19, 2025 · PGR2025-00050 · APJ Susan L C Mitchell · PGR · Institution

    The Board instituted PGR on claims 1–3 and 6–10 because Petitioner showed they were more likely than not to lack written-description support and enablement.

    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). Applying that standard on behalf of the Director (37 C.F.R. § 42.4(a)) and in consideration of the Petition and the cited 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 and 6– 10 of the ’791 patent, and therefore, we grant post-grant review for the reasons articulated below.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner’s proposal is sufficiently comprehensive to encompass the level of skill reflected in prior art relevant to the ’791 patent. It is reasonably clear that, in indicating that a POSA would have an advanced degree (like a Ph.D.) and years of experience in analysis of protein structure, Petitioner is asserting that knowledge of proteins generally is sufficient to understand the types of problems encountered in the art and the prior art solutions to those problems, and the ordinary artisan need not have expertise specifically in hyaluronidases. See Pet. 20. Petitioner requires that the POSA would be able to apply key scientific concepts (e.g., biochemistry, recombinant biology, sequence analysis and protein modeling) to enzymes such as hyaluronidases. See id. At this stage of the proceeding and on the record before us now, we apply Petitioner’s proposed POSA level, which 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).” slip op. at 9

    • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for patent owner

      “refers to a PH20 polypeptide that contains at least one amino acid modification, such as at least one amino acid replacement as described herein, in its sequence of amino acids compared to a reference unmodified PH20 polypeptide. A modified PH20 polypeptide can have up to 150 amino acid replacements, so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity. Typically, a modified PH20 polypeptide contains 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50 amino acid replacements. It is understood that a modified PH20 polypeptide also can include any one or more other modifications, in addition to at least one amino acid replacement as described herein. Id. at 47:4–18 (emphasis added). On this record, we find that the definition of “modified PH20 polypeptide” permits amino acid replacements in the PH20 polypeptide but only “so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.” Ex. 1001, 47:9–11. Indeed, while some of the language in the above paragraph is permissive in nature, i.e.., describing the number of amino acid replacements a modified PH20 polypeptide “can have” or “[t]ypically . . . contains” or the other modifications the polypeptide “can include,” the phrase “so long as” is not. See Ex. 1001, 47:4–18. This distinction demonstrates that hyaluronidase activity is not an optional feature, but a requirement of the “modified PH20 polypeptide” defined and claimed in the ’791 patent. See Alynylam Pharms., Inc. v. Moderna, Inc., 138 F.4th 1326, 1333 (Fed. Cir. 2025) (explaining that the “contrast” between “non-limiting terms” and more definitive statements may indicate that the latter is definitional). Thus, the evidence of record shows the ’791 patent recognizes a broad understanding of a “modified PH20 polypeptide” as encompassing PH20 sequences from a variety of different mammalian species, with or without precursor or signal sequences, with or without post-translational modifications, and with up to 150 amino acid replacements. The express definition of “modified PH20 polypeptide” in the ’791 patent permits up to 150 amino acid replacements but only “so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.” Ex. 1001, 47:9–11. That is, the provided definition of “modified PH20 polypeptide” in the ’791 patent expressly requires some hyaluronidase activity. On the current record, we therefore adopt the definition for “modified PH20 polypeptide” as recited in the ’791 patent to encompass polypeptides with some hyaluronidase activity. We determine that we need not expressly construe any other claim terms for the purpose of deciding whether to institute post-grant review. See 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 12

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

      “As we noted, on the current record claim 1 is reasonably interpreted to encompass PH20 polypeptides with some hyaluronidase activity. But even if we were to find that immunization using PH20 polypeptide as a contraceptive antigen serves to satisfy the utility requirement for the instant claims, there is a similar concern as to whether modified PH20 polypeptides with significant differences from the native protein as encompassed by claim 1 would maintain the antigenic determinants necessary to function as contraceptives. See Ex. 1003 ¶ 122. That the modified PH20 polypeptides would be homogenous in function is contradicted both by evidence in the ’791 patent itself and by Dr. Hecht and Dr. Parker. The ’791 patent discloses synthesis of 6,753 single amino acid mutations in residues 1‒447 of SEQ ID NO: 3. See Ex. 1001, 199:15–200:34. The ’791 patent teaches that just under 10% of these mutations, i.e. over 600, “exhibit activity that is increased compared to wildtype.” Id. at 233:1–2. Appendix A of Dr. Hecht’s Declaration shows 3,380 of these mutations were inactive, or 57.13%. See Ex. 1003, Appendix A-1, 171. Thus, the ’791 patent evidences that even when only a single mutation is made in the PH20 polypeptide, that single mutation is more likely than not to alter the structure in such a way as to inactivate the hyaluronidase activity found in the native PH20 polypeptide. On this record, Dr. Hecht persuasively demonstrates that when the full scope of claim 1 is addressed, which includes not just single mutations in the PH20 polypeptide, but also multiple mutations, there is no expectation of structural homogeneity, stating that “[i]ntroducing multiple amino acid changes simultaneously . . . could prevent the folding of sequences into secondary structures and structural motifs and can destabilize those structures if they do form.” Ex. 1003 ¶ 59. Dr. Hecht notes that claim 1 allows “up to 21 changes, with each additional change (except at position 309) being to any of 19 alternative amino acids. But the up to 21 changes also can be at any of 433 different positions.” Id. ¶ 129. Dr. Park calculates that the number of distinct polypeptides that meet the claimed criteria “is extremely large by all accounts, ranging from 1049 to 1060 distinct polypeptides.” See Ex. 1004 ¶ 161. Dr. Hecht characterizes the number of possible mutations as “astronomical in size.” Ex. 1003 ¶ 134.” slip op. at 20

    Claim construction§ 112 disclosure
    Patents in suitUS 12,077,791
  • PTAB · Nov 13, 2025 · PGR2025-00042 · APJ Susan L C Mitchell · PGR · Institution

    The Board instituted PGR on claims 1, 2, 5, and 7–33, finding likely written-description and enablement failures; it found the obviousness showing insufficient.

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

      “XII. CONCLUSION Petitioner has, at this stage of the proceedings, established that it will more likely than not prevail in showing that at least one of the challenged claims is unpatentable. This determination is, however, based on a preliminary record and is not final on any issues of patentability. We will make a final determination on the patentability of the challenged claims, as necessary and applying the preponderance of the evidence standard, based on a fully developed record through trial. XIII. ORDER In consideration of the foregoing, it is hereby: ORDERED that, pursuant to 35 U.S.C. § 324(a) post grant review of claims 1, 2, 5, and 7–33 of the ’618 patent is hereby granted on the grounds set forth in the Petition, commencing on the entry date of this Order, and pursuant to 35 U.S.C. § 324(d) and 37 C.F.R. § 42.4, notice is hereby given of the institution of a trial; and” slip op. at 46

    • Skill levelSkill level petitioner adoptedOther

      “Petitioner’s proposal is sufficiently comprehensive to encompass the level of skill reflected in prior art relevant to the ’618 patent. It is reasonably clear that, in indicating that a POSA would have an advanced degree (like a Ph.D.) and years of experience in analysis of protein structure, Petitioner is asserting that knowledge of proteins generally is sufficient to understand the types of problems encountered in the art and the prior art solutions to those problems, and the ordinary artisan need not have expertise specifically in hyaluronidases. See Pet. 15–16. Petitioner requires that the POSA would be able to apply key scientific concepts (e.g., biochemistry, recombinant biology, sequence analysis and protein modeling) to enzymes such as hyaluronidases. See id. At this stage of the proceeding and on the record before us now, we apply Petitioner’s proposed POSA level, which 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).” slip op. at 9

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

      “On this record, however, we find that the entire text quoted above is part of the definition of “modified PH20 polypeptide” because it continues to detail specific elements required including a requirement that replacements in the PH20 polypeptide are permitted “so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.” Ex. 1001, 47:2–4; see Ex. 2001 ¶¶ 48, 67 (stating a “patent’s definition controls”). Indeed, while some of the language in the definitional paragraph is permissive in nature, i.e.., describing the number of amino acid replacements a modified PH20 polypeptide “can have” or “[t]ypically . . . contains” or the other modifications the polypeptide “can include,” the phrase “so long as” is not. See Ex. 1001, 47:1–11. This distinction demonstrates that hyaluronidase activity is not an optional feature of a non-limiting example as Patent Owner posits, but a requirement of the “modified PH20 polypeptide” defined and claimed in the ’618 patent. See Alynylam Pharms., Inc. v. Moderna, Inc., 138 F.4th 1326, 1333 (Fed. Cir. 2025) (explaining that the “contrast” between “non-limiting terms” and more definitive statements may indicate that the latter is definitional). Moreover, Dr. Triggs-Raine recognizes the “therapeutic use of hyaluronidases” and notes that “different hyaluronidases were known to have different functions and substrates.” Ex. 2001 ¶¶ 29, 113.6 That is, Dr. Triggs-Raine recognizes hyaluronidase activity as the primary utility for the modified PH20 polypeptides recited in claim 1.” slip op. at 13

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

      “Every patent must describe an invention. It is part of the quid pro quo of a patent.” Ariad, 598 F.3d at 1345. Ariad explains that for generic claims the question may still remain whether the specification, including original claim language, demonstrates that the applicant has invented species sufficient to support a claim to a genus. The problem is especially acute with genus claims that use functional language to define the boundaries of a claimed genus. In such a case, the functional claim may simply claim a desired result, and may do so without describing species that achieve that result. But the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus. Id. at 1349. Ariad explains “that an adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials.” Id. at 1350. Ariad also held that functional claim language can meet the written description requirement when the art has established a correlation between structure and function. . . . But merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species. Id. slip op. at 21

    Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
    Patents in suitUS 12,037,618
  • PTAB · Nov 4, 2025 · IPR2025-00718 · APJ Zhenyu Yang · IPR · Institution

    The Board instituted IPR on all challenged claims, claims 1–4 and 6–26, on all asserted grounds because Petitioner showed a reasonable likelihood of prevailing on at least one claim.

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

      “inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). For the reasons provided below, we determine Petitioner has satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). We institute inter” slip op. at 2

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

      “On the current record, it is unclear to what extent, if at all, the alleged “scientific basis for the invention” describes adding bromine to coal. Written description requires more than that the disclosure renders the claimed subject matter obvious. Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1571–72 (Fed. Cir. 1997) (“The question is not whether a claimed invention is an obvious variant of that which is disclosed in the specification. Rather, a prior application itself must describe an invention.”); PowerOasis, Inc. v. T-Mobile USA, Inc., 522 F.3d 1299, 1306 (Fed. Cir. 2008) (“Entitlement to a filing date does not extend to subject matter which is not disclosed, but would be obvious over what is expressly disclosed.”).” slip op. at 18

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

      “The standard for public accessibility is one of “reasonable diligence,” Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1348 (Fed. Cir. 2016), to locate the information by “interested members of the relevant public.” Constant v. Advanced Micro-Devices, Inc., 848 F.2d 1560, 1569 (Fed. Cir. it was ‘disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it.’” Blue Calypso, 815 F.3d at 1348 (quoting Kyocera Wireless Corp. v. Int’l Trade Comm’n, 545 F.3d 1340, 1350 (Fed. Cir. 2008)). Patent Owner argues that “Petitioners rely on their paid technical expert’s largely uncorroborated fact testimony regarding a conference that took place twenty years ago.” Prelim. Resp. 27. Patent Owner asserts that “Petitioners have not corroborated the number of people in attendance at this track during the relevant time, nor whether those people were skilled in the art.” Id. Thus, Patent Owner concludes that “Petitioners have not provided sufficient evidence that Sjostrom was disseminated or otherwise made available to . . . persons interested and ordinarily skilled in the subject matter or art.” Id. (quotation marks omitted). We are not persuaded by Patent Owner’s argument. Petitioner relies on the testimony of Dr. Niksa, who attended and delivered a presentation at the 2005 EUEC. Ex. 1002 ¶¶ 125, 242–251; Ex. 1030, 3, 7, 23, 32, 106–118; Ex. 1031. Dr. Niksa testifies that there were over 800 attendees. Ex. 1002 ¶ 250. Other evidence corroborates Dr. Niksa’s testimony. Ex. 1030, 103–118 (list of attendees); Ex. 1031. Petitioner’s evidence does not indicate that attendance of the 2005 EUEC was restricted, and the evidence indicates that the CD appears to have been disseminated without any apparent restriction or expectation of confidentiality. Ex. 1002 ¶¶ 243, 244, 248; Ex. 1010; Ex. 1030, 103–118; Ex. 1031; GoPro, 908 F.3d at 694–95. reasonable likelihood that Sjostrom was publicly available, and thus, qualifies as printed publications. See Hulu, LLC v. Sound View Innovations, LLC, IPR2018-01039, Paper 28 (PTAB Dec. 20, 2019) (Paper 29) (precedential).” slip op. at 28

    § 102 anticipation§ 112 disclosurecites Phillips
    Patents in suitUS 10,926,218
  • PTAB · Nov 4, 2025 · IPR2025-00717 · APJ Zhenyu Yang · IPR · Institution

    The Board instituted IPR on claims 1–4 and 6–26 on all six asserted obviousness grounds, finding a reasonable likelihood that PacifiCorp would prevail.

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

      “We have authority under 35 U.S.C. § 314, 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.” 35 U.S.C. § 314(a). For the reasons provided below, we determine Petitioner has satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). We institute inter” slip op. at 2

    • PTAB / AIA Trials › Discretionary denialOther

      “1 Birchtech Corp. was formerly known as Midwest Energy Emissions Corp. (“ME2C”) (Paper 9, 2), 2 The parties also filed briefs, arguing for and against discretionary denial. Papers 16, 18. The Acting Director determined that discretionary denial was not appropriate and referred the Petition to the Board. Paper 24.” slip op. at 2

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

      “Vosteen589’s system to include Starns’s activated charcoal injection, because activated charcoal injection was “a ‘mature’ technology [and] the combination of Vosteen589 and Starns represents [nothing more than] combining prior art elements according to known methods to yield predictable results of removing mercury.” Id. at 29 (citing Ex. 1002 ¶¶ 285–288). Petitioner further explains that this combination results in “improved mercury removal (compared to activated carbon alone) with lowered sorbent costs.” Id. at 27–28 (citing Ex. 1002 ¶¶ 287). Similarly, Petitioner asserts that “the combination of Vosteen589 and Mass-EPA represents [nothing more than] combining prior-art elements according to known methods to yield predictable results of removing mercury,” because activated carbon injection “was ready for commercialization by 2002, years before the ’218 Patent’s earliest possible priority date.” Id. at 30 (citing Ex. 1002 ¶¶ 289–293). As support, Petitioner points to Mass-EPA’s teaching that activated carbon, as “the most extensively studied sorbent for mercury adsorption,” was “the most likely candidate to reach commercialization for mercury removal in the near future.” Id. at 29 (citing Ex. 1009, 32); see also Ex. 1009, 32 (“Increased removal of mercury from gas has been demonstrated by co-injection of activated carbon and calcium-based sorbents in spray dryer adsorber systems in full-scale coal-fired power plants.”). Petitioner also alleges that Mass-EPA provides an express motivation to combine the teachings of these references, that is, to “improv[e] mercury adsorption efficiency of activated carbons . . . with the goal of improving carbon to mercury injection rates and reducing control costs.” Pet. 30 (citing Ex. 1009, 39); see also id. at 29 (“Availability of low-cost and efficient sorbents and effective particulate collection are key in implementation of this type of mercury control.”) (citing Ex. 1009, 32); id. at 29–30 (“[E]stimated costs for powdered activated carbon injection-based technology, which most likely will reach commercialization for mercury control before other technologies, is within the current control costs for NOx.”) (citing Ex. 1009, 58). Petitioner contends that using Mass-EPA’s activated carbon injection in Vosteen589’s method would result in “improved mercury-adsorption efficiency, achieving the Mass-EPA’s stated goal of ‘reducing control costs.’” Id. at 30 (citing Ex. 1002 ¶ 294). The current record supports that Petitioner’s combination of Vosteen589 with Starns and with Mass-EPA would have been “the mere application of a known technique to a piece of prior art ready for the improvement.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 401 (2007). Indeed, “if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill.” Id. Patent Owner does not allege that the combination was beyond the skill level of a POSITA at the time of the alleged invention. See generally Prelim. Resp. Thus, for purposes of this Decision, Petitioner has provided sufficient reasoning with rational underpinnings to explain why a POSITA would have modified the teachings of the applied references, with a reasonable expectation of success. See KSR, 550 U.S. at 418.” slip op. at 15

    • Expert testimonyPetitioner expert creditedOther

      “To the extent that any portions of Dr. Niksa’s testimony may be contradictory, Patent Owner will have the opportunity to test the veracity of Dr. Niksa’s opinions over the course of trial. Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 596 (1993) (“Vigorous cross-examination [and] presentation of contrary evidence . . . are the traditional and appropriate means of attacking shaky but admissible evidence.”).” slip op. at 17

    § 103 obviousnessDiscretionary denialcites Phillips · KSR
    Patents in suitUS 10,926,218
  • PTAB · Oct 23, 2025 · IPR2025-00989 · APJ Timothy G Majors · IPR · Institution

    The Board instituted IPR on all challenged claims based on the asserted grounds, finding a reasonable likelihood of success on the Schaffer-Hartley and Schaffer-Eller combinations.

    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 it is determined that there is a reasonable likelihood that the petitioner will prevail with respect to at least one of the claims challenged in the petition. For reasons explained below, we conclude that Petitioner shows a reasonable likelihood that it will prevail with respect to at least one of the ’291 patent’s challenged claims. We institute inter partes review on all challenged claims. See SAS Inst. Inc. v. Iancu, 584 U.S. 357, 362–63 (2018); 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”). Findings and conclusions at this stage are preliminary and based on the current record. Any final decision will be based on a full trial record.” slip op. at 2

    • Skill levelSkill level patent owner adoptedDecided for patent owner

      “We agree with Patent Owner that Petitioner’s proposed POSA definition lacks specificity. That definition, if interpreted generically, could mean that a person may qualify as a POSA if they had, for example, a B.S. in mechanical engineering and only two years of experience designing or engineering any type of product in any field. That is too broad. We find that a POSA would have had the agreed-upon educational credentials—an undergraduate degree in mechanical engineering or a related engineering discipline. Ex. 1003 ¶ 36; Ex. 2001 ¶ 73. We find that a POSA would also have had 2–4 years of design or engineering experience related to products in the field of the invention, which involves endovascular devices and the surgical procedures that use such devices. Ex. 1001, 1:24–60 (background of the invention). Such devices include, but are not necessarily limited to, hemostasis valves and catheters for minimally-invasive vascular surgeries. Id. And, consistent with the testimony of the parties’ experts, the POSA need not have had firsthand experience designing hemostasis valves. See, e.g., Ex. 1029 (Zalesky Tr.), 72:11–73:7 (testifying direct experience “designing” hemostasis valves or aspiration catheters is not necessary, but “general experience with vascular devices and procedures” is required); Ex. 2006 (Thornton Tr.), 180:13–19. Further, as Dr. Zalesky testified, the POSA’s experience related to developing such devices “could be as simple as bench testing and looking at clinical data.” Ex. 1029, 74:5–75:1. Lastly, a POSA would have had an” slip op. at 12

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

      “As noted above, the challenged claims require a “filament formed in a loop around the tubular sidewall” where, when a portion of the filament is pulled away from the loop, the loop’s diameter reduces, thereby reducing the diameter of the lumen formed by the tubular sidewall to seal the valve. See supra Section II.D. Every embodiment in the ’291 patent where the filament is described as forming a “loop” in the manner claimed involves a filament that is necessarily flexible. See, e.g., Ex. 1001, 13:17–29, Figs. 6–7. The valve would not work if the looped filament were somehow inflexible— pulling an end of the filament would not change the diameter of the loop, and the valve would not seal. Ex. 2001 ¶ 65 (testifying “a loop in a rigid component would necessarily be fixed in size” and the “inherent property of flexibility is essential to the loop structure of the claims”); Ex. 1023, 16–17” slip op. at 17

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable

      “We are unpersuaded that Schaffer describes a valve with a filament as claimed. If, as construed above (supra Section III.C), the filament requires flexibility, Petitioner has not demonstrated that Schaffer describes such a feature in its valves. Instead, we agree with Patent Owner that a POSA would more likely understand Schaffer’s two U-shaped actuating members as being rigid features. Prelim. Resp. 33–36. We agree with Patent Owner that Petitioner implicitly admits that Schaffer’s actuating members are rigid leakage around tools inserted through the central lumen when in use and compared to the use of a flexible string or wire (of Hartley or Eller). Prelim. Resp. 34 (citing Pet. 51). We also find Dr. Zalesky’s interpretation of Schaffer more plausible than Mr. Thornton’s on the question of whether a POSA would have regarded Schaffer’s actuating members as being rigid structures. Ex. 2001 ¶¶ 78–85 (testifying, inter alia, that a POSA would have understood from Schaffer’s disclosure about making the actuator and actuating members from machining pre-existing amounts of metals and/or plastics, and further explaining that flexible parts would deform and be difficult to machine through conventional techniques); Ex. 1005 ¶¶ 81–82. Mr. Thornton opines that Schaffer’s disclosed manufacturing techniques for the actuator/actuating members are only examples and “a person of ordinary skill in the art could have simply purchased pre-made [flexible] flat wire or plastic tapes or ribbons.” Ex. 1003 ¶ 96. Such opinion invokes, at best, obviousness-based reasoning. This does not establish that Schaffer alone describes a filament sufficient to anticipate the claims. Furthermore, Mr. Thornton’s opinion that a POSA “would have understood that Schaffer’s U-shaped actuating members would have preferably been formed from a thin, flexible material” finds no support in Schaffer itself. Ex. 1003 ¶ 95. This opinion is also at odds with his testimony in related cases about an alleged formation of gaps with Schaffer’s actuating members, which suggested those members had a set “size” and lacked flexibility. See IPR2025-01157 (Ex. 1003 ¶ 81 (testifying a POSA “would have recognized that Hartley’s flexible string may better seal the valve than Schaffer’s metallic/plastic actuating members” because, “if a tool did not fit the size of” slip op. at 31

    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,865,291
  • PTAB · Oct 14, 2025 · IPR2025-00685 · APJ John G New · IPR · Institution

    The Board instituted IPR on claims 1–23 and all petitioned grounds, finding a reasonable likelihood that the claims are obvious over Wei and Liu.

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

      “Summary Based upon the record as presently developed, we conclude that Petitioner has met its burden of showing a reasonable likelihood of showing at trial that at least claim 1 of the ’370 patent is obvious over the cited prior art. Because we determine that Petitioner has demonstrated a reasonable likelihood of success at trial in showing that at least one claim is unpatentable on at least one of the stated Grounds, we institute inter partes review of all challenged claims of the ’370 patent, based on all of the remaining grounds identified in the Petition. See 37 C.F.R. § 42.208(a); SAS Inst., Inc. v. Iancu, 584 U.S. 357, 371 (2018); 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”).” slip op. at 44

    • Skill levelSkill level board ownOther

      “appears to be generally consistent with the level of skill presented in the cited prior art. See generally, e.g., Exs. 1005–1008; see also Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself may reflect an appropriate level of skill in the art). However, at this point we reject the portion of Petitioner’s proposed definition that includes having “access to other individuals with that knowledge and experience,” as not reflecting the individual level of skill of a given skilled artisan. See, e.g., Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986) (holding that “[t]he person of ordinary skill is a hypothetical person who is presumed to be aware of all the pertinent prior art. The actual inventor’s skill is not determinative”) (emphasis added, footnotes omitted). Consequently, and for the purposes of this Decision, we adopt Petitioner’s proposed definition as defining a person of ordinary skill in the art as a person who would have had “a Ph.D. in immunology, molecular biology, cellular biology, or a similar field, or an M.D. with similar experience, and would further have had at least five years of experience with antibodies and antibody engineering.”” slip op. at 6

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningOther

      “Petitioner states that no term of the challenged claims requires construction to resolve the challenges in this Petition. Pet. 32. Patent Owner does not contest Petitioner’s assertion. See generally Prelim. Resp. We find, for the purposes of this Decision, that no terms of the challenged claims require construction beyond the ordinary and customary meaning of the terms, as understood by a person of ordinary skill in the art at the time of the invention. Phillips, 415 F.3d at 1312–13.” slip op. at 7

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

      “We find, based upon the present record and for the purposes of this Decision, that Petitioner has sufficiently established that a person of ordinary skill in the art would have been motivated to combine the teachings of Wei and Liu to determine the activity and suitability of Liu’s humanized anti- EGFR antibodies in an ADC. We acknowledge that Liu is silent regarding the pH selectivity or tissue preference of its binding affinity, but Patent Owner points to no prior art reference that would have informed a skilled artisan upon this point or that would have discouraged a person of ordinary skill in the art from combining the references. See fn.7, supra. And, even if a skilled artisan might have recognized that Liu’s humanized cetuximab might have been potentially problematic if it failed to show pH-selective activity like Wei’s Y104D, the mere fact that some disadvantage may come with an advantage when combining prior art does not foreclose their combination under § 103. Medichem, S.A. v. Rolabo S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006). In the instance of Liu’s humanized anti-EGFR antibody, a person of ordinary skill in the art would have recognized that its advantages (enhanced activity against tumor cells compared to chimeric cetuximab, thus requiring smaller dosages) could balance or outweigh its possible disadvantages (e.g., possible activity against non-tumor cells). Furthermore, it is in the nature of scientific research to continue to try new substitutions in drug therapy, even if a promising candidate has been discovered. As the Supreme Court stated in KSR: 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. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103. 550 U.S. at 421.” slip op. at 39

    Claim construction§ 103 obviousnesscites Phillips · KSR
    Patents in suitUS 10,792,370
  • PTAB · Oct 14, 2025 · IPR2025-00688 · APJ Avelyn M Ross · IPR · Institution

    The Board instituted IPR on claims 1–18 on all asserted grounds, finding a reasonable likelihood that Petitioner would prevail on at least one challenged claim.

    RulingsInstitution decision
    • PTAB / AIA Trials › §315(b) time barNot time barredDecided for petitioner

      “The mere existence of some relationship between a petitioner and another entity, however, is not sufficient to place that petitioner in privity with that entity. Google LLC v. DDC Technology, LLC, IPR2023-00707, Paper 27 at 37 (PTAB Oct. 25, 2023). Instead, that relationship must be related to an earlier lawsuit and be “sufficiently close that it can be fairly said that the petitioner had a full and fair opportunity to litigate the validity of the patent in that lawsuit” or the evidence must show “the petitioner is simply serving as a proxy to allow another party to litigate the patent validity question that the other party raised in an earlier-filed litigation.” WesternGeco, 889 F.3d at 1319.” slip op. at 10

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner asserts that “[a] person of ordinary skill in the art [“POSITA”] would have at least a bachelor’s degree in chemical engineering, mechanical engineering, or a related field of study with at least two years of experience implementing pollution control in power generation plants for natural gas, coal, and/or industrial waste incineration.” Pet. 11 (citing Ex. 1002 ¶¶ 48–51). Patent Owner does not dispute the level of ordinary skill in the art. See generally Prelim Resp. For purposes of this Decision, we adopt Petitioner’s proposed definition of a person of ordinary skill in the art because it is consistent with the skill level reflected in the disclosures of the ’370 patent and prior art. See Okajima, 261 F.3d at 1355 (the prior art may reflect an appropriate level of skill in the art).” slip op. at 12

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

      “Petitioner “do[es] not, at this time, contend that any term requires construction,” and instead, states that “[a]ll terms have been accorded their plain and ordinary meaning.” Pet. 10 (citing Ex. 1002 ¶¶ 212–215). Patent Owner does not propose any constructions at this time. See generally Prelim. Resp. Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to construe any claim term expressly.” slip op. at 13

    • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateDecided for petitioner

      “We are not persuaded by this argument. The Federal Circuit has instructed that [e]ntitlement to a filing date does not extend to subject matter which is not disclosed, but would be obvious over what is expressly disclosed. It extends only to that which is disclosed. While the meaning of terms, phrases, or diagrams in a disclosure is to be explained or interpreted from the vantage point of one skilled in the art, all the limitations must appear in the specification. The question is not whether a claimed invention is an obvious variant of that which is disclosed in the specification. Rather, a prior application itself must describe an invention, and do so in sufficient detail that one skilled in the art can clearly conclude that the inventor invented the claimed invention as of the filing date sought. Lockwood, 107 F.3d at 1571–72. Here, what “a POSITA would understand,” without disclosure in the specification, is insufficient to show written-description support. Prelim. Resp. 24. Thus, on this record, and for purposes of institution, Patent Owner has not shown that the Provisional Application provides sufficient support for adding the claimed genus to the coal. 3. Summary In sum, on this record, Patent Owner has not shown that either the Provisional Application or the Pre-2018 Applications provide sufficient written-description support for the challenged claims. As a result, we determine that the ’370 patent cannot claim priority to the Provisional Application. Thus, all asserted prior art qualifies as prior art.” slip op. at 25

    Claim construction§ 102 anticipation§ 112 disclosurecites Phillips
    Patents in suitUS 10,933,370
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