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  • PTAB · Oct 14, 2026 · IPR2022-00817 · APJ Zhenyu Yang · IPR · Remand

    On remand, the Board found Travers ’075 did not enable RCR amplification followed by SMRT sequencing and held claims 1–30 not shown unpatentable under the asserted obviousness grounds.

    RulingsRemand decision
    • RemandOther

      “B. Scope on Remand On remand, we are bound by the terms of the Federal Circuit’s mandate. Intell. Pixels Ltd. v. Sony Interactive Ent. LLC, 181 F.4th 1216, 1220 (Fed. Cir. 2026) (“An administrative agency is bound by the mandate of a reviewing court much as a lower court is bound by the mandate of a higher court.”). According to the Federal Circuit, on appeal, Patent Owner “UW argues that ‘Travers ’075 does not enable the sequencing of an RCR concatemer using PacBio’s SMRT sequencing,’ and therefore because paragraph 122 is not enabled, it cannot be relied on for disclosing amplification followed by sequencing.” Paper 50, 14. Because “[t]he Board did not reach this issue,” the Federal Circuit “remand[ed] the case for consideration of this issue by the Board in the first instance.” Id. Thus, consistent with the court’s mandate, we must decide “whether Travers ’075 enabled RCR amplification followed by SMRT sequencing.” Id. at 8.” slip op. at 4

    • BurdenNot shown unpatentable

      “A prior art reference is presumed to be enabled. Amgen, Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1355 (Fed. Cir. 2003) (holding that “a presumption arises that both the claimed and unclaimed disclosures in a prior art patent are enabled”); In re Antor Media Corp., 689 F.3d 1282, 1288 (Fed. Cir. 2012) (extending the presumption to prior art printed publications). A patent owner, however, may present persuasive evidence that the relevant disclosures of a prior art are not enabled and therefore are not pertinent prior art. Amgen, 314 F.3d at 1355; In re Antor Media, 689 F.3d at 1289 (discussing the applicant’s burden to submit rebuttal evidence of nonenablement during prosecution); Apple Inc. v. Corephotonics, Ltd., 861 Fed. App’x. 443, 450 (Fed. Cir. 2021) (“[R]egardless of the forum, prior art patents and publications enjoy a presumption of enablement, and the patentee/applicant has the burden to prove nonenablement for such prior art.”). “[T]here is no absolute requirement for a relied-upon reference to be self-enabling in the § 103 context, so long as the overall evidence of what was known at the time of invention establishes that a skilled artisan could have made and used the claimed invention.” Raytheon Techs. Corp. v. Gen. Elec. Co., 993 F.3d 1374, 1376–77 (Fed. Cir. 2021). But, “if an obviousness case is based on a non-self-enabled reference, and no other prior art reference or evidence would have enabled a skilled artisan to make the claimed invention, then the invention cannot be said to have been obvious.” Id. at 1377.” slip op. at 15

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached

      “The Federal Circuit stated that “the elements of the challenged claim are expressly taught by Travers ’075. Travers ’075 discloses performing RCR amplification followed by SMRT sequencing in a single embodiment.” Paper 50, 14. As a result, “no finding regarding a motivation to combine to arrive at those claimed elements is required.” Id. at 9. In addition, it was error to require Petitioner to show that a skilled artisan “would have had a reasonable expectation of success in performing RCR replication of SMRTbell templates followed by SMRT sequencing.” Id. at 13. “Unless remanded by [an appellate] court, all issues within the scope of the appealed judgment are deemed incorporated within the mandate and thus are precluded from further adjudication.” Engel Indus., Inc. v. Lockformer Co., 166 F.3d 1379, 1383 (Fed. Cir. 1999). Therefore, the only issue for us to decide is “whether Travers ’075 enabled RCR amplification followed by SMRT sequencing.” Paper 50, 8.” slip op. at 14

    • Expert testimonyPatent owner expert creditedDecided for patent owner

      “polymerase-template complexes in the same ZMW.” Id. (citing Ex. 1035, 39). Citing the Larrea Declaration, Petitioner contends that loading of multiple templates “is easily mitigated.” Id. at 18 (citing Ex. 1033 ¶ 19; Ex. 1035, 39). We are not persuaded by this argument either. Dr. Larrea testifies that one of the two methods to “easily mitigate[]” loading multiple templates into a single ZMW is “bioinformatically trimming the read to only the high-quality region (HQR).” Ex. 1033 ¶ 19. Dr. Larrea, however, provides no support for this testimony. In fact, he does not even explain what a “high-quality region (HQR)” is. We, thus, accord little weight to this testimony. See Xerox Corp. v. Bytemark, Inc., IPR2022-00624, Paper 9 (August 24, 2022) (precedential) (holding “conclusory and unsupported” declaration testimony is entitled to little weight).” slip op. at 26

    Patent outcomesUS 10,760,127 not shown unpatentable
    § 103 obviousness
    Patents in suitUS 10,760,127
  • PTAB · Oct 6, 2026 · IPR2025-00728 · APJ Timothy G Majors · IPR · Final written decision

    Claims 1–7, 9, 10, 15–18, and 20–24 are unpatentable as obvious over Schaffer with Hartley or Eller; claims 1–3, 5, 6, 9, 15–18, and 21–24 are also obvious over Hartley and Eller.

    RulingsFinal written decision
    • Skill levelSkill level board ownDecided for patent owner

      “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 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 ¶ 35; Ex. 2033 ¶ 61. 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, 1:16–54 (background of the invention). Such devices include, but are not limited to, hemostasis valves and catheters for testimony of the parties’ experts, the POSA need not have had first-hand experience designing hemostasis valves. See, e.g., Ex. 1037 (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). 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.” Id. at 74:5–75:1. Lastly, a POSA would have understood such devices’ design requirements as determined by the needs of the physician, patient, and procedure, which understanding may be informed by work experience or study. Ex. 2030, 24:5–21.” slip op. at 12

    • Expert testimonyPetitioner expert creditedPatent owner expert creditedMixed

      “above (supra Section III.C), a filament requires flexibility, Petitioner has not demonstrated that Schaffer describes that feature in its valves. Instead, Patent Owner persuades us that Schaffer describes “rigid U-shaped actuating members—not a ‘filament.’” PO Resp. 23–24.13 We find Dr. Zalesky’s interpretation of Schaffer more credible than Mr. Thornton’s on the question of whether a POSA would have regarded Schaffer’s actuating members as being substantially rigid structures. Ex. 2033 ¶¶ 91–100 (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 testifies 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 [and flexible] flat wire or plastic tapes or ribbons.” Ex. 1003 ¶ 79. Such testimony invokes, at best, obviousness-based reasoning. This does not establish that Schaffer alone describes a filament sufficient to anticipate the claims. Trintec Indus., Inc. v. Top-U.S.A. Corp., 295 F.3d 1292, 1296 (Fed.” slip op. at 28

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionDecided for patent owner

      “Patent Owner cites intrinsic evidence in support of its interpretation, which include claim 1’s recitation of an “active tensioning mechanism” comprising the filament and the Specification’s description of a filament that can be both “loosened” and “tightened.” PO Resp. 14–17 (citing, e.g., Ex. 1001, 9:36–37, 9:53–56 (teaching “the filament 150 is tightened” when the actuator buttons are released and “the filament 150 is loosened” when the buttons are pressed to open the valve)); see also Ex. 2025, 1288 (defining “tension” as to “tighten to a desired or appropriate degree”). These descriptions from the patent are more consistent with the view that the filament is characteristically flexible, not rigid. 10 We reached the same conclusion, based on substantially the same records, in the Institution Decision and the Final Written Decisions in the 1157, 156, and 289 IPRs. Inst. Dec. 14–18; Ex. 1042, 14–24; Ex. 1048, 16–23; Ex. 1049, 14–17 (noting the parties’ agreement at oral hearing that there was no additional argument or evidence about whether a filament requires flexibility that was not already addressed in related matters). After we construed the “filament” term to require flexibility at institution, Petitioner provided no further argument or evidence on this issue in its authorized trial briefing or at oral hearing. See generally Pet. Reply. embodiments (where the filament forms one or more loops like depicted and described in Figures 6–7) require a flexible structure. See, e.g., Ex. 2032, 15–16 (explaining that the device would not work to constrict the tubular sidewall and lumen (analogous to the elongate member defining a lumen of the claims here) if the filament forming the loop(s) was inflexible); Ex. 1001, Figs. 6–7 (filament 150, with sub-filaments 150-A and 150-B). Although flexibility of the filament in the patent’s “bight” embodiments (e.g., as shown in Figures 8 and 9) is less clear, there is a dearth of evidence from Petitioner—either intrinsic or extrinsic to the patent—showing why a POSA would have understood the bights as embracing rigid structures. See Ex. 1001, Figs. 8–9. Moreover, as admitted by Petitioner’s expert, that a filament may be made from various materials described in the patent (e.g., synthetics or metals) does not, absent more information, lead to a conclusion that a filament is “rigid.” Ex. 2030, 125:2–126:4 (testifying “the relative stiffness or rigidity is not clear from those . . . materials without knowing much more information”).” slip op. at 16

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

      “We find that Petitioner has not shown, by a preponderance of the evidence, that Schaffer anticipates claim 1 or any of the other challenged claims, each of which requires at least one “filament.” We are unpersuaded above (supra Section III.C), a filament requires flexibility, Petitioner has not demonstrated that Schaffer describes that feature in its valves. Instead, Patent Owner persuades us that Schaffer describes “rigid U-shaped actuating members—not a ‘filament.’” PO Resp. 23–24.13 We find Dr. Zalesky’s interpretation of Schaffer more credible than Mr. Thornton’s on the question of whether a POSA would have regarded Schaffer’s actuating members as being substantially rigid structures. Ex. 2033 ¶¶ 91–100 (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 testifies 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 [and flexible] flat wire or plastic tapes or ribbons.” Ex. 1003 ¶ 79. Such testimony invokes, at best, obviousness-based reasoning. This does not establish that Schaffer alone describes a filament sufficient to anticipate the claims. Trintec Indus., Inc. v. Top-U.S.A. Corp., 295 F.3d 1292, 1296 (Fed.” slip op. at 27

    Patent outcomesUS 11,844,921 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,844,921
  • PTAB · Aug 13, 2026 · IPR2025-01531 · APJ Zhenyu Yang · IPR · Final written decision

    Claims 1, 3–6, and 8–14 are unpatentable as obvious; claims 2, 7, and 15 were not shown unpatentable because the prior art did not establish the claimed drug sequence.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Patent Owner states that, for purposes of this proceeding, it does not dispute Petitioner’s proposed definition of a POSA. PO Resp. 8. Based on the entirety of the trial record, we adopt Petitioner’s proposed definition of a POSA’s skill level because it is consistent with the skill level reflected in the disclosures of the ’552 patent and 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

    • Expert testimonyPatent owner expert creditedDecided for patent owner

      “We decline to discount Dr. Oberstein’s opinion based on the alleged conflict of interest and bias. Dr. Oberstein testified that the consulting fees he receives from Patent Owner reflect a small fraction of his income. Ex. 1210, 402:21–403:9. We also agree with Patent Owner that an oncologist prescribing an FDA-approved regimen does not evince bias. See Sur-reply 23; see also Ex. 1206, 49 (showing NALIRIFOX is a category 1, NCCN-preferred first-line therapy for metastatic pancreatic cancer), 69 (explaining category 1 is based upon high-level evidence). Petitioner also contends that Dr. Oberstein “offers conclusory opinions,” “fails to properly apply the law, continues to look at each reference in isolation, refuses to acknowledge logical suggestions in the art, and imports new limitations into the claims.” Reply 3–4. We evaluate each piece of evidence, including Dr. Oberstein’s opinion, as it relates to our substantive patentability analysis, and accord it proper weight.” slip op. at 9

    • ExcludeMotion to exclude, deniedDenied

      “Petitioner, as the moving party, bears the burden of proving that the material sought to be excluded is inadmissible under the Federal Rules of Evidence. See 37 C.F.R. §§ 42.20(c), 42.62(a); see also Trial Practice Guide (“TPG”)15 § II.K (“A motion to exclude must explain why the evidence is not admissible.”). For the reasons explained below, we deny Petitioner’s Motion.” slip op. at 17

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

      “only on a ground that could be raised under section 102 or 103 and only on the basis of prior art consisting of patents or printed publications.” 35 U.S.C. § 311(b). Whether a reference qualifies as a “printed publication” involves a case-by-case inquiry into the facts and circumstances surrounding the reference’s disclosure to the public. In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004). A reference is publicly accessible upon a satisfactory showing that such document has been 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. Kyocera Wireless Corp. v. ITC, 545 F.3d 1340, 1350–51 (Fed. Cir. 2008). Conroy was published on May 12, 2011. Ex. 1003, 1. Conroy refers to Conroy Protocol (Ex. 1004), stating that “[t]he protocol, including the statistical analysis plan, is available with the full text of this article at NEMJ.org.” Ex. 1003, 3. When questioned whether he has “any reason to believe that the protocol would not have been provided on NEJM.org with this text when it was published,” Dr. Oberstein testified that “if they say they provided it, then I think they probably provided it.” Ex. 1210, 165:20–166:2. 17 Alternatively, to the extent necessary, under the circumstances of this case, we waive the requirement of § 42.63(b). See 37.C.F.R. § 42.5(b). In addition, Dr. Ratain testified that “most top journals require that the protocol be submitted at the time of initial submission, and it’s always published alongside any major paper.” Ex. 2073, 42:2–5. According to Dr. Ratain, “[c]ertainly, New England Journal of Medicine does that.” Id. at 42:6–7. We credit the testimony from both Dr. Oberstein and Dr. Ratain on this issue. Accordingly, we find Exhibit 1004 was publicly accessible at the same time Conroy was published. slip op. at 28

    Patent outcomesUS 11,344,552 mixed
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 11,344,552
  • PTAB · Aug 13, 2026 · IPR2025-00505 · APJ Zhenyu Yang · IPR · Final written decision

    Claims 1, 3–6, and 8–14 are unpatentable as obvious over the first § 103 combination; claims 2, 7, and 15 were not shown unpatentable because the art did not support the claimed drug sequence.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner asserts that [t]he person of ordinary skill in the art (POSA) would have been an M.D. and/or Pharm. D who would have completed training in medical oncology, particularly in the field of gastrointestinal (GI) cancers, or a Ph.D. in clinical pharmacology, pharmaceutical sciences, pharmaceutics, and/or drug delivery, also particularly in the field of GI cancers, or their equivalents, along with at least 1-2 years of post-doctoral experience. Pet. 26 (citing Ex. 1002 ¶¶ 44–46). Patent Owner states that, for purposes of this proceeding, it does not dispute Petitioner’s proposed definition of a POSA. PO Resp. 8. Based on the entirety of the trial record, we adopt Petitioner’s proposed definition of a POSA’s skill level because it is consistent with the skill level reflected in the disclosures of the ’552 patent and 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

    • Expert testimonyPatent owner expert creditedDecided for patent owner

      “We decline to discount Dr. Oberstein’s opinion based on the alleged conflict of interest and bias. Dr. Oberstein testified that the consulting fees he receives from Patent Owner reflect a small fraction of his income. Ex. 1210, 402:21–403:9. We also agree with Patent Owner that an oncologist prescribing an FDA-approved regimen does not evince bias. See Sur-reply 23; see also Ex. 1206, 49 (showing NALIRIFOX is a category 1, NCCN-preferred first-line therapy for metastatic pancreatic cancer), 69 (explaining category 1 is based upon high-level evidence). Petitioner also contends that Dr. Oberstein “offers conclusory opinions,” “fails to properly apply the law, continues to look at each reference in isolation, refuses to acknowledge logical suggestions in the art, and imports new limitations into the claims.” Reply 3–4. We evaluate each piece of evidence, including Dr. Oberstein’s opinion, as it relates to our substantive patentability analysis, and accord it proper weight.” slip op. at 9

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

      “In the DI, the Board stated that the ordinary understanding of a claim reciting a “method of treating metastatic adenocarcinoma of the pancreas” that comprises “administering an antineoplastic therapy to the patient” in order “to treat the metastatic adenocarcinoma of the pancreas” is that the “treatment” would have more than a de minimis therapeutic benefit or efficacy for the patient being treated. DI 14. We, however, rejected the notion that the claims “would require some particular degree of clinical efficacy” because “the level of clinical efficacy is not a claim limitation.” Id.” slip op. at 12

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Not reached

      “The parties, however, disagree over whether each recited dose must be the starting dose. Petitioner argues that “claim 1 requires that the method of treatment is a first-line therapy, but does not require that the claimed doses be used as a starting dose.” Paper 51, 1. In contrast, Patent Owner argues that “[t]he specification describes that the recited dose of each drug is a ‘starting’ or ‘initial’ dose.” Paper 50, 2 (citing Ex. 1001, 13:38–45, 30:5–7). For purposes of this Decision, we do not need to resolve this dispute. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (stating that claim terms need only be construed to the extent necessary to resolve the controversy). As explained below, we agree with Petitioner that, even if claim 1 recites the starting dose for each drug, Petitioner has shown, by a preponderance of the evidence, that the prior art teaches each dose and a POSA would have had a reason to start with the recited doses. See infra Section II.G.3; Paper 51, 3 n.2. Because we find that the prior art teaches or suggests the claimed subject matter even under Patent Owner’s proposed narrower claim interpretation, we need not further construe the disputed claim language.” slip op. at 16

    Patent outcomesUS 11,344,552 mixed
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 11,344,552
  • PTAB · Jun 9, 2026 · IPR2025-00289 · APJ Timothy G Majors · IPR · Final written decision

    Claims 1–15 are unpatentable: claims 1–15 under Grounds 2 and 3, and claim 10 under Ground 4; Ground 1 did not establish unpatentability.

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

      “We have construed the “filament” term in multiple related proceedings and agreed with Patent Owner that the claimed filament requires flexibility. See Ex. 1050 (Final Written Decision in 156 IPR); IPR2024-01157, Paper 35 (Final Written Decision) at 15–24. Specifically, we determined that the evidence supports Patent Owner’s position that “a POSA would have understood the plain and ordinary meaning of the claimed ‘filament’ as a flexible length of material (e.g., one or more string(s), wire(s), tape(s)).” See, e.g., Ex. 1050, 23. We maintain that construction in this Decision for the reasons given by Patent Owner (see PO Resp. 24–32; PO Sur-reply 6–8), we disagree with Petitioner’s argument to the contrary (Pet. Reply 27–31), and we incorporate our analysis concerning the meaning of the filament term from the related proceedings identified above, which applies equally here.13 Ex. 1050 (Final Written Decision in 156 IPR); IPR2024-01157, Paper 35 (Final Written Decision) at 15–24. The parties agreed at the oral hearing that there is no additional argument or evidence 13 Although the ’005 patent is not directly related to the patents at issue in the 1157 and 156 IPRs, the ’519 Application that the ’005 patent purports to incorporate for providing all relevant disclosures about the filament term is a parent application to the challenged patents in the 1157 and 156 IPRs (see supra n.3). SightSound Techs., LLC v. Apple Inc., 809 F.3d 1307, 1316 (Fed. Cir. 2015) (“Where multiple patents derive from the same parent application and share many common terms, we must interpret the claims consistently across all asserted patents.”) (internal quotation marks omitted). We also construed the filament term consistently in other ongoing proceedings on related patents. See, e.g., Ex. 1045 (Institution Decision in the 728 IPR), 12–18; Ex. 1046 (Institution Decision in the 989 IPR), 13–21. already addressed in those related matters. Tr. 6:13–23, 23:19–26.” slip op. at 16

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “B. Level of Ordinary Skill in the Art Petitioner contends that the person of ordinary skill in the art (“POSA”) in August 2018 “would have had an undergraduate degree in mechanical engineering or a related engineering discipline and 2–4 years of catheter design experience.” Pet. 17 (citing Ex. 1003 ¶ 35). Although Patent Owner states that it “disagrees” with Petitioner’s POSA definition, Patent Owner nevertheless applies that definition in this case. PO Resp. 32–33; see Tr. 22:23–23:5 (Patent Owner is “not disputing” Petitioner’s definition, asserting the definition “doesn’t make any difference in this case”).” slip op. at 13

    • Expert testimonyPatent owner expert creditedPetitioner expert creditedMixed

      “We credit Dr. Zalesky’s interpretation of Schaffer on whether the POSA would have understood Schaffer as describing rigid actuating members. Dr. Zalesky testifies, for example, that a POSA would have understood from Schaffer’s disclosures about the actuating members being “machined” from metal or plastic, that such actuating members would be rigid. Ex. 2026 ¶ 101 (explaining “machining is a manufacturing process in which the desired part . . . is created using the controlled removal of bulk material” to produce a “rigid material”); Ex. 1005 ¶ 82 (“The actuating member 55 and the actuating button 261 is machined from aluminum” and “[i]n another example, the actuating member 55 and the actuating button 261 are machined from plastic”); Ex. 2026 ¶¶ 102–103 (testifying the disclosed valve assembly technique in Schaffer (Ex. 1005 ¶ 83) also indicates that “rigid” actuating members are used). Mr. Thornton opines (without citation to any persuasive supporting disclosure) that a POSA “would have understood that Schaffer’s U-shaped actuating members would have preferably been formed from a thin, flexible material.” Ex. 1003 ¶ 113. But, at deposition, Mr. Thornton conceded that machined plastics and aluminum, like disclosed in Schaffer, are rigid. Ex. 2005, 168:2–6 (“Q. And you said that plastic that would be machined would be rigid, correct? A. I think that’s a fair statement.”). Although Mr. Thornton opines that Schaffer’s actuating members would “preferably”” slip op. at 29

    • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableUnpatentableMixed

      “For the reasons above, Petitioner has not established that the claimed “filament” is disclosed in the combination of Garrison and Schaffer and, thus, Petitioner has not shown by a preponderance of the evidence that claim 1 would have been obvious over Garrison and Schaffer. Petitioner’s challenge to independent claim 10 (and the claims that depend from claim 1 and claim 10) fails for similar reasons. Each of the challenged claims requires a “filament” and, given our construction of that term and our findings above that Schaffer does not teach or suggest the claimed filament, Petitioner has not proved by a preponderance of the” slip op. at 31

    Patent outcomesUS 11,554,005 unpatentable
    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,554,005
  • PTAB · May 13, 2026 · IPR2025-00028 · APJ Zhenyu Yang · IPR · Final written decision

    Claims 1–15 and 17–22 are unpatentable as obvious over the specified combinations of Shapero, Delseny, and, for certain claims, Hamady or Jones.

    RulingsFinal written decision
    • Skill levelSkill level board ownDecided for patent owner

      “In the DI, we addressed Patent Owner’s arguments disputing Petitioner’s proposed definition. DI 17–18 (citing Prelim. Resp. 11–12). We stated that for purposes of this Decision, we find a POSA would have had a Ph.D. in molecular biology, molecular genetics, bioinformatics, biochemistry, or a related field. Alternatively, a POSA would have had a B.S. or M.S. degree with three to five years of experience working in any of those fields. Additionally, the POSA would have had experience with NGS sequencing methods and a working knowledge of how those methods functioned. Id. at 18. After institution, Patent Owner states that, for purposes of this proceeding, it adopts the Board’s definition of a POSA. PO Resp. 12. Based on the entirety of the trial record, we maintain our finding of a POSA’s skill level.” slip op. at 9

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

      “Claim Construction In an inter partes review, we construe a claim term “using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. [§] 282(b).” 37 C.F.R. § 42.100(b) (2020). Under that standard, the words of a claim “are generally given their ordinary and customary meaning,” which is “the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application.” Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). 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 9

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
    • Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner

      “A reference teaches away “when a person of ordinary skill, upon reading the reference, would be discouraged from following the path set out in the reference, or would be led in a direction divergent from the path that was taken by the applicant.” In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). “The prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed.” Id.” slip op. at 29

    Patent outcomesUS 10,036,012 unpatentable
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 10,036,012
  • PTAB · May 13, 2026 · IPR2025-00029 · APJ Zhenyu Yang · IPR · Final written decision

    Claims 1–12 and 14–19 are unpatentable as obvious over the listed combinations; Petitioner’s motion to strike is denied.

    RulingsFinal written decision
    • Skill levelSkill level board ownDecided for petitioner

      “for purposes of this Decision, we find a POSA would have had a Ph.D. in molecular biology, molecular genetics, bioinformatics, biochemistry, or a related field. Alternatively, a POSA would have had a B.S. or M.S. degree with three to five years of experience working in any of those fields. Additionally, the POSA would have had experience with NGS sequencing methods and a working knowledge of how those methods functioned.” slip op. at 7

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

      “claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. [§] 282(b).” 37 C.F.R. § 42.100(b) (2020). Under that standard, the words of a claim “are generally given their ordinary and customary meaning,” which is “the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application.” Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). 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 8

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
    • Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner
    Patent outcomesUS 10,876,108 unpatentable
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 10,876,108
  • PTAB · May 12, 2026 · IPR2025-00026 · APJ Georgianna W Braden · IPR · Final written decision

    Claims 1–10 are unpatentable: claims 1–3 and 5–10 are anticipated by Porreca and obvious over Schmitt and McCloskey; claims 4 and 7 are also obvious over the listed Illumina combinations.

    RulingsFinal written decision
    • Skill levelSkill level board ownDecided for patent owner

      “On the initial trial record, we agreed with Patent Owner that one of ordinary skill in the art would have had experience with next generation sequencing, but were not persuaded that this would only be possible in the field of molecular biology. Instead, we found that a person of ordinary skill would have had either (1) a Ph.D. in the field of chemistry, molecular biology, or biochemistry or (2) a B.S. or M.S. degree with three to five years of experience working in any of those fields. Inst. Dec. 8. We specifically found that “[t]he person of ordinary skill would have had experience with next generation sequencing methods and a working knowledge of how those methods functioned.” Id. at 8–9. Patent Owner now submits that it does not dispute the definition of a person of ordinary skill in the art as laid out in the Institution Decision. PO Resp. 13. Reviewing the entire trial record, we maintain the same definition of a person of ordinary skill in the art and note that it is consistent with the skill level reflected in the disclosures of the ’357 patent and prior art. We further note that the skill level does not affect our analysis or our final decision.” slip op. at 10

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

      “In the Institution Decision, the Board adopted Petitioner’s construction of the term “adaptor.” Inst. Dec. 9. Patent Owner does not dispute this construction. PO Resp. 13–14. During oral argument, Petitioner argued that claim 1 requires “an adapter to be ligated onto a target DNA, and that adapter needs to have two different sequences of DNA that are used for identification” including a “socalled identifier that's one to eight nucleotides in an indexing site.” Tr. 6:19–7:2. Patent Owner, again, did not dispute this characterization of “adaptor.” See generally Tr. Based on the entirety of the trial record, we continue to apply Petitioner’s construction of the term “adaptor,” although we note that it does not affect our analysis.” slip op. at 12

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

      “Based on the entirety of the trial record, we do not agree with Patent Owner’s reading of either the claims or the prior art because Patent Owner takes too narrow a view of both. First, based on the plain language of Porreca, we find it uses a combination of the sequence reads of the target sequence and differentiator tag sequences to determine whether there is duplication. See Ex. 1006 ¶¶ 139–140, 143, 148, 153. All that the claim requires is that the method identifies sequence reads with identical identifier and target sequences as duplicates. Because claim 1 contains the transition “comprising,” the claim is still satisfied if the category of identified duplicate reads contains identical labels and also contains more. Patent Owner admits that the identifier and target sequence do not have to be used simultaneously. Tr. 46:16–48:4. Instead, Patent Owner challenges whether Porreca uses the required elements in combination as recited in the challenged claims. Based on the record before us, we agree with Petitioner’s position especially in view of the open-ended nature of the claims and Patent Owner’s own admission that there is no temporal requirement for the use of target sequences and differentiator tag sequences. Specifically, we find that Porreca teaches using the combination of the target sequences and the differentiator tag sequence to determine whether particular sequence reads are unique or PCR duplicates. See Ex. 1006 ¶¶ 139–140, 143, 148, 153. The use of both such sequences meet the claim limitations. This finding is consistent with the prosecution history of the ’357 patent and how the applicant and examiner interpreted the claims. See Ex. 1013, 69–70, 78–79. Second, we find the disclosure of Porreca sufficient to demonstrate to an ordinarily skilled artisan that “collapsing” is done by comparing target sequences and differentiator tag sequences. Porreca specifically explains that: after multiple reads have been collected for a given locus, it is possible that due to bias (e.g., caused by PCR amplification steps), a large fraction of the reads are derived from a single originating molecule. This would skew the population of target sequences observed, and would affect the outcome of the genotype call.” slip op. at 30

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

      “We do not agree with Patent Owner for at least two reasons. First, Patent Owner fails to address the fact that Schmitt cites to McCloskey 2007. We find that the citation of McCloskey 2007 in Schmitt indicates that the ordinarily skilled artisan would have considered the teachings of McCloskey to be highly relevant to the teachings of Schmitt and would have considered them to be both useful in the field of sequencing. See Ex. 1005 ¶ 6. Second, Patent Owner fails to explain or even identify the purported structural differences between Schmitt and McCloskey that would prevent the teachings of McCloskey from being relevant to Schmitt. In addition, we credit the testimony of Dr. Metzker that one of ordinary skill in the art would have understood the benefits of adding a barcode to target sequences and would have looked to McCloskey and the batch-stamps it teaches because both Schmitt and McCloskey are in the same field and address the same problems. See Ex. 1003 ¶¶ 110, 114. Accordingly, we find that Petitioner has demonstrated by a preponderance of the evidence that a person of ordinary skill in the art at the critical time would have had sufficient reason to combine the teachings of Schmitt and McCloskey to arrive at challenged claim 1.” slip op. at 48

    Patent outcomesUS 11,098,357 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · Graham
    Patents in suitUS 11,098,357
  • PTAB · Apr 8, 2026 · IPR2024-01504 · APJ Georgianna W Braden · IPR · Final written decision

    Claims 1–4, 6, 7, 9, and 10 are unpatentable under § 102 over Bielas and § 103 over Iafrate and Kivioja and Bielas.

    RulingsFinal written decision
    • Skill levelSkill level board ownDecided for patent owner

      “On the initial trial record, we agreed with Patent Owner that Petitioner’s asserted level of ordinary skill in the art is higher than warranted when Petitioner argues that a person of ordinary skill “further would have had specific experience with implementing and designing library preparation methods.” Pet. 21–22. We disagreed with Patent Owner, however, that an ordinarily skilled artisan only needs to “have had experience with DNA sequencing methods” (see Prelim. Resp. 8) because an artisan with experience based only on pre-NGS sequencing methods would not qualify as a person of ordinary skill. Instead, we found that a person of ordinary skill would have had either (1) a Ph.D. in the field of chemistry, molecular biology, or biochemistry or (2) a B.S. or M.S. degree with three to five years of experience working in any of those fields. Inst. Dec. 9. We specifically found that “[t]he person of ordinary skill would have had experience with NGS sequencing methods and a working knowledge of how those methods functioned.” Id.” slip op. at 10

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

      “1. “indexing site” Petitioner argues that the ’357 patent defines “indexing site” as a sample index, specifically, “a nucleic acid sequence that acts as an index for multiple polynucleotide samples, thus allowing for the samples to be pooled together into a single sequencing run, which is known as multiplexing.” Pet. 23 (citing Ex. 1004, 4:40–44). Patent Owner did not disagree initially with Petitioner’s proposed construction other than to argue that no claim requires construction. Prelim. Resp. 9. In our Institution Decision, we noted that the ’357 patent states: An indexing site is a nucleic acid sequence that acts as an index for multiple polynucleotide samples, thus allowing for the samples to be pooled together into a single sequencing run, which is known as multiplexing. the ’357 patent to provide a definition for “indexing site,” and we construed the term in accordance therewith. The parties do not dispute this definition and we maintain that construction for our analysis here. See PO Resp. 9; Reply 6–14.” slip op. at 11

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

      “In some embodiments, duplicate sequencing reads are differentiated from one another as being true duplicates versus apparent or perceived duplicates. Apparent or perceived duplicates may be identified from sequencing libraries and using conventional measures of duplicate reads (i.e., reads were mapped using bowtie), where all reads with the same start and end nucleic acid coordinates were counted as duplicates. True duplicates may be identified from sequencing libraries having had an identifier site introduced through ligation to differentiate between fragments of DNA that randomly have the same start and end mapping coordinates. Ex. 1004, 14:21–31; see id. at Fig. 5; see also Example 1, 18:6-15 (When evaluating two million random reads, the apparent duplicates were found to comprise 39% of all reads. However, the true duplicates, identified through The methods employing the use of an identifier site were found to considerably increase the resolution of the true number of duplicates within the pool of reads.). The ’357 patent also discloses in Example 5: “Any read that has identical sequence to any other read is identified as a duplicate and removed from the population, thus, only a single copy is retained within the file.” Ex. 1004, 20:60–62. Analyzing the patent disclosure in light of the parties’ arguments, we determine that “duplicates” in claim 1 of the ’357 patent means the sequences possess an identical sequence for both the identifier and the length of the sequence read that is obtained. Additionally, we agree with the parties that there is no temporal requirement for “identifying sequence reads” using the identifier and the target sequence, and the two do not have to be used simultaneously. Rather, based on both Examples 1 and 5 of the ’357 patent, the claims only require that the two data points be used for “identifying sequence reads.”” slip op. at 15

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

      “4. “comprising” The Board preliminarily construed “comprising” as an open-ended transition that is not limited to the listed steps. See Inst. Dec. 13 (citing Vivid Techs., Inc., 200 F.3d at 811). Patent Owner agrees that the “comprising” transitional phrase of the challenged claims leaves open the possibility that additional steps can be included in the method, but argues that it should not “be interpreted so broadly as to effectively eliminate the step of identifying duplicates as claimed.” PO Resp. 18. Patent Owner argues that a “broad interpretation of the claims cannot be read to include a method in which the identifying duplicates step only identifies sequences with PCR or SBS errors and does not identify duplicates in the manner include only identification of reads without duplicate sequences (those that contain PCR or SBS errors) makes this limitation superfluous and cannot be the correct interpretation.” Id. Patent Owner argues that the proper construction of the claims (1) covers a method of identifying sequence reads that are identical as duplicates through a process that uses both the identifier and at least a portion of the target sequence, and (2) does not exclude methods that include a step of identifying PCR errors in addition to the claimed step of identifying duplicates. Id. at 19. Petitioner agrees with Patent Owner and states “[a]ll claim 1 requires is that two sequences are identified as duplicates using the claimed method, even if the method identifies as duplicates additional sequences that are not 100% identical.” Reply 14 (citing Ex. 1124, 55:11–57:3; Ex. 1117). The Board agrees with the parties and we construe “comprising” as an open-ended transition, meaning the claims require, but are not limited to, the listed steps.” slip op. at 16

    Patent outcomesUS 11,098,357 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · Graham
    Patents in suitUS 11,098,357
  • PTAB · Apr 7, 2026 · IPR2025-00156 · APJ Timothy G Majors · IPR · Final written decision

    Claims 1–9 are unpatentable as obvious over Schaffer combined with Hartley or Eller, with or without Garrison; anticipation by Schaffer and obviousness over Schaffer alone were not shown.

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

      “The parties propose essentially the same formal educational background for the POSA, but we agree with Patent Owner that Petitioner’s proposed POSA definition lacks some specificity concerning the POSA’s work experience. That definition, if interpreted generically, could mean that a person qualifies as a POSA if they had, for example, a B.S. in mechanical engineering and only two years of experience with 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 ¶ 35; Ex. 2008 ¶ 76. 10 Although unspecified in this proceeding, in the related 1157 IPR, Patent Owner stated that the field of the invention is “hemostasis valves for use during intravascular procedures.” IPR2024-01157, Paper 13 at 22. 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. Furthermore, as pointed out by Petitioner and consistent with the testimony of the parties’ experts, the POSA need not have had firsthand experience designing relevant medical devices, including hemostasis valves. Pet. Reply 28; see, e.g., Ex. 1019 (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. As Dr. Zalesky testified, the POSA’s experience related to such devices “could be as simple as bench testing and looking at clinical data.” Ex. 1019, 74:5–75:1; see also id. at 82:3–6 (testifying a POSA need not “have specific experience with different methodologies of hemostasis”). Lastly, a POSA would have had an understanding of such devices’ design requirements as determined by the needs of the physician, patient, and procedure, which understanding may be informed by work experience and/or study. Ex. 2006, 24:5–21.” slip op. at 13

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

      “1. “aspiration catheter” Claim 1’s preamble recites “[a]n aspiration catheter.” Ex. 1001, 22:10. Petitioner contends that, as a general rule, a preamble does not limit the scope of a claim, and that the term “aspiration” here merely describes a non-limiting “intended use” of an otherwise structurally-complete invention defined by the body of the claim. Pet. 18–19. Patent Owner responds that 11 In the related 1157 IPR, Patent Owner moved to exclude Mr. Thornton’s testimony, which motion we denied. IPR2024-01157, Paper 35 at 70–72. Patent Owner filed no motion to exclude here. Owner’s arguments here.” PO Resp. 30. We need not further construe “aspiration catheter” as no dispute turns on that term’s meaning or whether it is limiting. Realtime Data, 912 F.3d at 1375 (explaining that claims need only be construed to the extent necessary to resolve matters in dispute).” slip op. at 15

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

      “That does not, however, resolve the dispute about “flexibility.” On that issue, after considering the full record developed through trial, we agree with Patent Owner that a “filament” as claimed is flexible. The claims support Patent Owner’s interpretation. Patent Owner cites the claim language, including the recitation that “the first filament [is] formed into a loop around the collapsible tubular sidewall defining a valve lumen” and that “a diameter of the valve lumen decreases in response to reducing a diameter of the loop.” As Patent Owner argues, and as we recognized at the institution stage, the claimed filament “must be flexible to constrict the valve lumen.” PO Resp. 23; Inst. Dec. 15–16; Ex. 2008 ¶ 68 (testifying that a POSA would understand this property of flexibility is essential to achieving the claimed loop formation and function). The Specification supports this understanding. Consider the “loop” embodiments as illustrated in Figures 6 or 7. Ex. 1001, Figs. 6–7. If the filament forming each depicted loop was somehow rigid, applying a force that seeks to pull the respective ends of the filament in opposing directions would not decrease the size of the loop—the loop would stay the same size and the filament would not circumferentially constrict and seal the elongate member’s lumen as described in the patent. Ex. 1001, 13:18–29.” slip op. at 18

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

      “Petitioner’s argument is unavailing. A steel beam or a plastic broom handle are longer than they are wide and yet conventionally rigid. And, specific to the subject matter here, as Mr. Thornton admits, machining the valve’s actuating members from plastic or metal, which Schaffer actually describes, would produce rigid members. Ex. 2005, 168:2–6; see also Ex. 2006, 152:8–10 (testifying a flexible aluminum wire would not be made from machining aluminum). Moreover, considering Schaffer’s cited drawings— Figure 32, in particular—does not show the actuating members changing shape or dynamically conforming to the outer surface of the seal module that those members are compressing, which, had that been shown, might indicate flexibility. Maybe the absence of any dynamic conformance of the surface of the actuating members is an unintended limitation or artifact of the drawing. Or maybe not, and what is shown is a rigid structure consistent with Schaffer’s other disclosures as already explained. We decline to find anticipation where Schaffer does not, with sufficient clarity and detail, describe a valve with a “filament” as claimed.21 Ultimately, on whether Schaffer describes rigid or flexible U-shaped actuating members, Dr. Zalesky’s interpretation of the reference is more plausible and we find greater evidentiary support for Patent Owner’s position on this issue. Notwithstanding Mr. Thornton’s testimony in his rebuttal declaration that a POSA reading Schaffer would have understood 21 Wasica Fin. GmbH v. Cont’l Auto. Sys., Inc., 853 F.3d 1272, 1284 (Fed. Cir. 2017) (“Anticipation requires that a single reference describe the claimed invention with sufficient precision and detail to establish that the subject matter existed in the prior art.”) (emphasis added and internal quotation marks omitted). testimony on cross-examination was equivocal—he admitted “[i]t’s not clear” whether Schaffer’s U-shaped actuating members are flexible or rigid. Ex. 2006, 115:16–23 (testifying “[t]he material properties of the U-shaped actuating members are not clearly defined in the Shafer [sic] application”). Dr. Zalesky, in contrast, has consistently testified that a POSA would have understood that Schaffer describes rigid actuating members. See, e.g., Ex. 2008 ¶¶ 66–74 (citing, inter alia, Schaffer’s illustrations of the valve in operation, and the disclosed manufacturing and assembly methods as indicating that “the actuating members 55 are rigid rather than flexible”).” slip op. at 40

    Patent outcomesUS 11,697,012 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,697,012
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