• Guardant Health, Inc. v. University Of WashingtonNo claims unpatentable
  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
• Imperative Care, Inc. v. Inari Medical, Inc.All claims unpatentable
  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
• Shenzhen Root Technology Co., Ltd. v. Willow Blossom Holdco Limited And Willow Innovations, Inc.All claims unpatentable
  PTAB · Sep 25, 2026 · IPR2025-00554 · APJ Barry L Grossman · IPR · Final written decision

  Claims 17–19 and 21–33 are unpatentable as obvious under each asserted § 103 ground.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Factors pertinent to a determination of the level of ordinary skill in the art include: (1) educational level of the inventor; (2) type of problems encountered in the art; (3) prior art solutions to those problems; (4) rapidity with which innovations are made; (5) sophistication of the technology; and (6) educational level of workers active in the field. Env’t Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696–697 (Fed. Cir. 1983) (citing Orthopedic Equip. Co. v. All Orthopedic Appliances, Inc., 707 F.2d 1376, 1381–82 (Fed. Cir. 1983)). Not all such factors may be present in every case, and one or more of these or other factors may predominate in a particular case. Id. Moreover, these factors are not exhaustive but are merely a guide to determining the level of ordinary skill in the art. Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). In determining a level of ordinary skill, we also may look to the prior art, which may reflect an appropriate skill level. Okajima, 261 F.3d at 1355.” slip op. at 17

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

    “according to the Phillips standard,” and that “no formal claim constructions are necessary for purposes of resolving controversies in this proceeding. Pet. 3. We agree. Given the lack of dispute on this record, we do not perceive the need to construe any claim limitation. Claims must be construed “only to the extent necessary to resolve the controversy.” AstraZeneca AB v. Mylan Pharms. Inc., 19 F.4th 1325, 1345 (Fed. Cir. 2021) (quoting Vivid Techs., Inc. v. American Science & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“Because we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy,’ we need not construe the claim preambles here where the construction is not ‘material to the [obviousness] dispute.’” (citations omitted)).” slip op. at 18

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “We find Mr. Bauer’s testimonial evidence persuasive and undisputed as to why a person of ordinary skill, a degreed engineer with two years of experience designing human breast pump equipment, would modify Furrer to use a battery as a power source, and have a reasonable degree of confidence that it would work successfully.” slip op. at 26

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

    “We find Mr. Bauer’s testimonial evidence persuasive and undisputed as to why a person of ordinary skill, a degreed engineer with two years of experience designing human breast pump equipment, would modify Furrer to use a battery as a power source, and have a reasonable degree of confidence that it would work successfully. Concerning the proposed combination of Furrer and Alvarez, Mr. Bauer testifies why a person of ordinary skill would combine Furrer and Alvarez, explaining that: a POSITA6 would have turned to the teachings of Alvarez to implement Furrer’s vacuum pump using a conventional pump controller having a portable, battery-powered pump to not only increase portability and to allow the user to move about when using the device but also to provide improved control for the system. Ex. 1003 ¶ 138. Mr. Bauer also testifies: a POSITA would have recognized that Alvarez advantageously provides details for such a conventional vacuum pump suitable for safely and controllably delivering negative pressure using a “[c]ontroller 115 [that] “houses the power source and drive mechanism for pumping device 100, and also contains hardware for various functions, such as controlling pumping device 100, milk production quantification, and communication with other devices. 6 “POSITA” is a patent law acronym for a “person of ordinary skill in the art.” Id. ¶ 139 (citing Ex. 1005 ¶ 69). Mr. Bauer further explains that Alvarez discloses that a “pump unit2100 [disclosed in Alvarez] preferably include[es] a controller and processor 2104 as well as a motor 2102 for actuating the device.” Id. (citing Ex. 1005 ¶ 115); see also id. ¶¶ 140–142 (providing “second,” “third,” and “fourth” reasons why a person of ordinary skill would have been motivated to combine Furrer and Alvarez). Mr. Bauer concludes from his analysis that “a person skilled in the art” slip op. at 26

  Patent outcomesUS 11,806,454 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,806,454
• Clearwater Paper Corporation v. Graphic Packaging International LLCAll claims unpatentable
  PTAB · Sep 23, 2026 · IPR2025-00878 · APJ Carl M Defranco · IPR · Final written decision

  Claims 1–3 and 11 are unpatentable as anticipated by Cleveland and obvious over Nakagawa and over Nakagawa combined with Tanner.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “would have at least a bachelor’s degree in mechanical or chemical engineering, materials science, polymer science, or equivalent coursework, at least a year of experience developing paper-based laminates involving the application of polymer coatings to a substrate, and the appropriate industry familiarity with biodegradability standards and degradability techniques [and] . . . [l]ess work experience may be compensated by a higher level of education, such as a master’s degree, and vice versa. Pet. 16 (citing Ex. 1003 ¶ 50). Clearwater’s definition is uncontested, and we apply that definition here, as it accords with the level of skill reflected in the asserted prior art and the problems addressed in the specification of the ’126 patent. C. Claim Construction” slip op. at 6

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “We have reviewed the cited testimony of Clearwater’s expert, including their calculations for arriving at a coat weight in Nakagawa that falls within the claimed range. See Ex. 1003 ¶¶ 132–33. We find that testimony, which is unrebutted, both credible and supported by the evidence of record. Thus, in light of Clearwater’s contentions, the cited portions of Nakagawa, and the unrebutted testimony of Clearwater’s expert, we are persuaded that Nakagawa discloses or otherwise suggests each and every element of claim 1. See Pet. 45–54, 60–64. Clearwater also persuades us that Cleveland discloses the additional subject matter of dependent claims 2, 3, and 11. See Pet. 64–66. Thus, we determine that Clearwater demonstrates that claims 1–3 and 11 are unpatentable as obvious over Nakagawa. F. Ground 3—Obviousness Over Nakagawa and Tanner” slip op. at 17

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference is prior artDecided for petitioner

    “qualifies as prior art under 35 U.S.C. § 102(e)(1) “based on both its provisional and non-provisional filing dates.” Inst. Dec. 4 n.5. We were persuaded by Clearwater’s proof that Cleveland’s provisional (Ex. 1006) is “virtually identical” to Cleveland itself (Ex. 1005) and that the provisional provides written description support for at least claim 1 of Cleveland. See Pet. 18–21 (citing Ex. 1006, 2–6, 9). We were also persuaded by Clearwater’s showing that the provisional provides written support for the subject matter relied upon in Cleveland. Id. at 21–40 (citing Ex. 1006, 1–9). We are still persuaded by Clearwater’s showing. Thus, we see no reason to disturb our earlier finding that Cleveland is prior art to the ’126 patent.” slip op. at 7

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

    “protectant layers has “a coat weight of from 5 to 30 lbs/3000 ft2.” As noted by Clearwater, Cleveland discloses a total coat weight for layers 14 and 16 as falling within the claimed range. Pet. 32–34 (citing Ex. 1005 ¶ 32). In particular, Cleveland discloses that “the coextruded layer of copolyester (irrespective of which side of the substrate the layer is disposed) is of a total coat weight of between about 10 and about 40 lb/3000 ft2 in any combination of between about 80/20 to 20/80 parts by weight of Ecoflex to Biomax,” of which “a total coat weight of 25 lb/3000 ft2 is preferred.” Ex. 1005 ¶ 32. As disclosed, Cleveland’s total coat weight range of 10–40 lb/3000 ft2 falls almost entirely within the claimed range, and the preferred total coat weight of 25 lb/3000 ft2 falls squarely within the claimed range. Thus, Cleveland satisfies claim elements [1.3.2] and [1.5.2]. See Titanium Metals Corp. v. Banner, 778 F.2d 775, 782 (Fed. Cir. 1985) (“[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is anticipated if one of them is in the prior art.”) (citation omitted). As such, we find that Clearwater adequately demonstrates that Cleveland discloses all the elements of claim 1. 4. Dependent Claims” slip op. at 12

  Patent outcomesUS 8,637,126 unpatentable
  § 102 anticipation§ 103 obviousnesscites Phillips
  Patents in suitUS 8,637,126
• CSPC Pharmaceutical Group Limited / CSPC Ouyi Pharmaceutical Co., Ltd. et al. v. Ipsen Biopharm Ltd.Some claims unpatentable
  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
• CSPC Pharmaceutical Group Limited / CSPC Ouyi Pharmaceutical Co., Ltd. et al. v. Ipsen Biopharm Ltd.Some claims unpatentable
  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
• Shenzhen Root Technology Co., Ltd. v. Willow Blossom Holdco LimitedAll claims unpatentable
  PTAB · Jul 30, 2026 · IPR2025-00560 · APJ Barry L Grossman · IPR · Final written decision

  Claims 1–29 are unpatentable under each asserted obviousness ground, including Chang and Fang, because Petitioner proved unpatentability by a preponderance of the evidence.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “Additionally, we note that Patent Owner did not cross-examine Mr. Ryan Bauer, who provided a detailed, 169-page expert report providing, on behalf of Petitioner, his opinions about the issues in this proceeding. See Exhibit 1003. Mr. Bauer’s testimonial evidence in this proceeding remains unrebutted.” slip op. at 3

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner asserts that a person of ordinary skill in the art would have had “bachelor’s degree in mechanical engineering or a similar field and at least two years of experience designing human breast pump equipment. More education could substitute for experience and vice versa.” Pet. 8 (citing Ex. 1003 ¶¶ 15–18). Mr. Bauer’s Declaration testimony states he considered some of the factors listed above. Ex. 1003 ¶ 17. Mr. Bauer testifies that based on his background and experience, in his opinion, the level of ordinary skill is as stated by Petitioner. Id. at 18. Based on the prior art, the sophistication of the disclosed technology in the ’381 patent, and Mr. Bauer’s undisputed testimony, we adopt Petitioner’s definition of the level of ordinary skill.” slip op. at 17

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

    “Petitioner asserts that the Examiner construed the term “self- contained, in-bra wearable device” to mean “complete, or having all that is needed, in itself’ and is capable of being worn in a bra.” Pet. 8 (citing Ex. 1005, 2290).14 According to Petitioner, “[Patent Owner] did not dispute this construction, and Petitioner applies it herein.” Id. Petitioner contends that all other terms “should receive their plain and ordinary meaning.” Id. We do not perceive the need to construe any claim limitation. Claims must be construed “only to the extent necessary to resolve the controversy.” AstraZeneca AB v. Mylan Pharms. Inc., 19 F.4th 1325, 1345 (Fed. Cir. 2021) (quoting Vivid Techs., Inc. v. American Science & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“Because we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy,’ we need not construe the claim preambles here where the construction is not ‘material to the [obviousness] dispute.’” (citations omitted)).” slip op. at 17

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

    “(3) 1[a][1] a diaphragm configured to prevent milk from reaching an air pump by forming a seal around its outer edge; Petitioner relies on Fang for the disclosure of a diaphragm, as stated in this clause. Pet. 25–26. Petitioner asserts the proposed combination of elements suggest a breast pump device that would have used a diaphragm pump including first and second diaphragm housing components and an elastic diaphragm, “in accordance with Fang’s suggestions.” Id. at 25. As also asserted by Petitioner, Fang discloses that flexible diaphragm 7 (i.e., a membrane) is configured to prevent milk from reaching the pump. Id. at 26 (citing Ex. 1009 ¶ 19 (“The elastic diaphragm 7 is used to prevent milk from flowing into the air pump main unit 8.”). Mr. Bauer testifies: The flexible diaphragm [diaphragm 7 in Fang] forms a watertight and airtight seal around its outer edge. In doing so, the diaphragm prevents the passage of milk from reaching the air pump and facilitates generation of negative pressure during operation. Fang also explains that the elastic diaphragm 7 deforms away from the nipple tunnel when a vacuum is created on a pumping chamber, which then creates negative air pressure in the nipple tunnel when a vacuum is created on a pumping chamber.” slip op. at 28

  Patent outcomesUS 11,813,381 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,813,381
• Samsung Display Co., Ltd. v. Pictiva Displays International Ltd.All claims unpatentable
  PTAB · Jul 22, 2026 · IPR2024-01095 · APJ Garth D Baer · IPR · Remand

  On remand, the Board maintained its finding that claims 2 and 17 are unpatentable under §103 over Diekmann and Ma, and Suzuki and Ma.

  RulingsRemand decision

  • RemandDecided for petitioner

    “that is both n-doped and comprised of 8-hydroxy-quinolinolato-lithium (Liq). The district-court defendant’s first invalidity challenge relied primarily on Clix2, which lacked an n-doped ETL. Paper 48, 2, Paper 50, 3. Thus, the asserted combination required modifying Clix2’s non-doped ETL by adding an n-dopant. Clix2’s missing n-doped ETL appeared to be a focus at trial. See Ex. 2034, 917:1–18, 920:8–14. Here, in contrast, Petitioner proposed a more modest modification to materially different primary references, Suzuki and Diekmann, which both already have n-doped ETLs. See Paper 50, 2–3; Paper 54 8–9. As we explained in our Final Written Decision, because Patent Owner did not contest that Liq acts as an n-dopant in Ma, Petitioner’s combinations were obvious because they merely “substitute one known n-dopant for another to further the same goal of improving ETL conductivity.” Paper 54, 12. That simple-substitution analysis would not be the same when n-doping Clix2’s non-doped ETL. For this reason, we agree with Petitioner that the district-court Clix2-based combination “is a different combination with a materially different motivation-to-combine analysis,” as compared to the Diekmann/Suzuki and Ma combinations that are at issue here. Paper 50, 3.” slip op. at 2

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableMotivation foundUnpatentable

    “Dependent claims 2 and 17 require an electron transport layer (ETL) that is both n-doped and comprised of 8-hydroxy-quinolinolato-lithium (Liq). The district-court defendant’s first invalidity challenge relied primarily on Clix2, which lacked an n-doped ETL. Paper 48, 2, Paper 50, 3. Thus, the asserted combination required modifying Clix2’s non-doped ETL by adding an n-dopant. Clix2’s missing n-doped ETL appeared to be a focus at trial. See Ex. 2034, 917:1–18, 920:8–14. Here, in contrast, Petitioner proposed a more modest modification to materially different primary references, Suzuki and Diekmann, which both already have n-doped ETLs. See Paper 50, 2–3; Paper 54 8–9. As we explained in our Final Written Decision, because Patent Owner did not contest that Liq acts as an n-dopant in Ma, Petitioner’s combinations were obvious because they merely “substitute one known n-dopant for another to further the same goal of improving ETL conductivity.” Paper 54, 12. That simple-substitution analysis would not be the same when n-doping Clix2’s non-doped ETL. For this reason, we agree with Petitioner that the district-court Clix2-based combination “is a different combination with a materially different motivation-to-combine analysis,” as compared to the Diekmann/Suzuki and Ma combinations that are at issue here. Paper 50, 3.” slip op. at 2

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

    “that is both n-doped and comprised of 8-hydroxy-quinolinolato-lithium (Liq). The district-court defendant’s first invalidity challenge relied primarily on Clix2, which lacked an n-doped ETL. Paper 48, 2, Paper 50, 3. Thus, the asserted combination required modifying Clix2’s non-doped ETL by adding an n-dopant. Clix2’s missing n-doped ETL appeared to be a focus at trial. See Ex. 2034, 917:1–18, 920:8–14. Here, in contrast, Petitioner proposed a more modest modification to materially different primary references, Suzuki and Diekmann, which both already have n-doped ETLs. See Paper 50, 2–3; Paper 54 8–9. As we explained in our Final Written Decision, because Patent Owner did not contest that Liq acts as an n-dopant in Ma, Petitioner’s combinations were obvious because they merely “substitute one known n-dopant for another to further the same goal of improving ETL conductivity.” Paper 54, 12. That simple-substitution analysis would not be the same when n-doping Clix2’s non-doped ETL. For this reason, we agree with Petitioner that the district-court Clix2-based combination “is a different combination with a materially different motivation-to-combine analysis,” as compared to the Diekmann/Suzuki and Ma combinations that are at issue here. Paper 50, 3.” slip op. at 2

  Patent outcomesUS 11,828,425 unpatentable
  § 103 obviousness
  Patents in suitUS 11,828,425
• Innoscience America, Inc. v. Infineon Technologies Americas Corp.No claims unpatentable
  PTAB · Jun 30, 2026 · IPR2025-00175 · APJ Jo-Anne M Kokoski · IPR · Final written decision

  Claims 1–17 were not shown unpatentable because Petitioner failed to establish that Usui’s interconnect structure or Yu’s metal gate stacks satisfy the construed “electrode stack” limitation.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “(“POSITA” or “POSA”) would have had “at least a four-year degree in electrical engineering or a closely related field, and at least two years of experience in semiconductor device design,” and “[a]dditional education could substitute for professional experience and vice versa.” Pet. 6 (citing Ex. 1002 ¶¶ 80–82). Patent Owner does not dispute Petitioner’s proposed level of ordinary skill. PO Resp. 1–76. Neither party explains why the outcome of this case would be affected by the adoption of the proffered definition of a person of ordinary skill in the art. In the Institution Decision, we adopted the assessment offered by Petitioner. Dec. 6–7. Because Petitioner’s definition of the level of skill in the art is consistent with the ’562 patent and the asserted prior art, we maintain Petitioner’s definition for purposes of this Final Written Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir 2001).” slip op. at 9

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

    “comprises the recited metals and has the recited thickness, which forms an electrical contact for use on a semiconductor device generally or a group III- V semiconductor in particular. This is consistent with our determination that “electrode stack” is a conductor that provides a path for current entering or leaving a medium such as a semiconductor device We disagree with Patent Owner that “electrode stack” as used in the challenged claims should be limited to the specific electrodes shown in the embodiments described in the Specification. See PO Resp. 4–9. Although the Specification describes embodiments using source, drain, and Schottky gate electrodes as electrical contacts, we see no reason to construe the term “electrode stack” itself to be limited to these components as Patent Owner proposes. Claims 1 and 13 expressly recite that electrode stacks comprise the claimed “electrical contact,” without expressly including or precluding any specific type of electrode. Ex. 1001, 5:54–63, 6:37–47. The Federal Circuit advises that the Specification “is not a substitute for, nor can it be used to rewrite, the chosen claim language. ‘Specifications teach. Claims claim.’” SuperGuide, 358 F.3d at 875 (quoting SRI Int’l v. Matsushita Elec. Corp. of Am., 775 F.2d 1107, 1121 n.14 (Fed. Cir. 1985) (en banc)). The Specification does teach electrical contacts that include source, drain, and Schottky gate electrodes, but claims 1 and 13 are directed to electrical contacts that are not expressly so limited. Patent Owner’s proposed construction would effectively rewrite the claim by adding limitations, which we decline to do under the guise of claim construction. See id. (“Though understanding the claim language may be aided by the explanations contained in the written description, it is important not to import into a claim limitations that are not a part of the claim.”). In view of the foregoing, we construe the claim term “electrode stack” to mean “a conductor that provides a path for current entering or leaving a medium such as a semiconductor device.”” slip op. at 17

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “that the identified layers in Usui’s interconnect metallurgy structure form an “electrode stack including a plurality of metal layers and a capping layer formed over said plurality of metal layers” as recited in claim 1. See Pet. 11–12 (citing Ex. 1002 ¶¶ 89–91). Neither Petitioner nor Dr. Zhao, however, provide adequate explanation or evidence as to why Usui’s interconnect metallurgy structure forms an “electrode stack,” i.e., a conductor that provides a path for current entering or leaving a medium such as a semiconductor device. Dr. Zhao’s testimony merely repeats the disclosures in Usui and concludes, without further technical detail, explanation, or reference to objective evidence, that Usui’s Figure 8 discloses an electrode stack. Ex. 1002 ¶¶ 89–91. Dr. Zhao’s testimony sets forth Petitioner’s conclusory assertions as though they are facts, rather than setting forth facts and evidence in support of those assertions. Compare id. with Pet. 11–12. Absent underlying facts or evidence to support Dr. Zhao’s opinion, the cited testimony “adds little to the conclusory assertion for which it is offered to support, and is entitled to little weight.” Xerox Corp. v. Bytemark, Inc., IPR2022-00624, Paper 9 at 15 (PTAB Aug. 24, 2022) (precedential). In contrast, Patent Owner’s declarant Dr. Piner testifies, with evidentiary support, that interconnects (such as Usui’s interconnect metallurgy structure) and electrical contacts (such as that claimed in the ’562 patent) are not the same thing. See Ex. 2024 ¶¶ 63–70. For example, Dr. Piner explains: In other words, not all metals in a semiconductor device have the same purpose and could not be said to be interchangeable. By August 2009 it was well known to a POSA how to discern if a metal component in a transistor is an interconnect or serves as an electrical contact such as a gate contact or ohmic contact, based on the structure and functionality of the metal component. For example, interconnects are made up of metal strips and are deposited on insulators. EX-1011 (Mishra) at 216. Interconnects are low resistance conductors that can carry very high current densities. Id., 216, 217. Unlike Schottky contacts and ohmic contacts, interconnects do not provide non-linear IV response like Schottky contacts nor inject electrons and holes into semiconductors like ohmic contacts. Id., 218. As many of the references cited by Dr. Zhao illustrate, electrical contacts had their own highly complex design challenges. EX-1008 (Pearton), 41-59 (Pages 53-71 of 383) (discussing electrical contacts); EX-1017 (Kramer), 11-126 (Pages 18-130 of 151) (same). And while Dr. Zhao cites these as supporting a POSA’s knowledge of an electrical contact, none of these references describe electrical contacts as interconnects. Id. ¶ 71. Dr. Piner further testifies that Usui’s interconnect metallurgy structure is an interconnect, and not an electrical contact, because “Usui states that ‘[t]he structures fabricated by the process of the present invention are especially useful for forming electrical connections or wiring such as between active and/or passive devices of an integrated circuit structure.’” Id. ¶ 148 (citing Ex. 1004, 1:11–14) (alteration in original); see also id. ¶¶ 150– 151 (Dr. Piner testifying that Usui’s interconnect metallization structure is not an “electrode stack” under a broad definition of electrode). Dr. Piner’s testimony in this regard rebuts Petitioner’s and Dr. Zhao’s conclusory assertions to the contrary.” slip op. at 21

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

    “conductor that provides a path for current entering or leaving a medium such as a semiconductor device.” Thus, Petitioner must show that Usui’s layers 13–15, 18, and 19 provide a path for current entering or leaving a medium such as a semiconductor device. After reviewing the complete trial record, we are not persuaded that Petitioner has done so. Petitioner relies on the testimony of Dr. Zhao to support its contention that the identified layers in Usui’s interconnect metallurgy structure form an “electrode stack including a plurality of metal layers and a capping layer formed over said plurality of metal layers” as recited in claim 1. See Pet. 11–12 (citing Ex. 1002 ¶¶ 89–91). Neither Petitioner nor Dr. Zhao, however, provide adequate explanation or evidence as to why Usui’s interconnect metallurgy structure forms an “electrode stack,” i.e., a conductor that provides a path for current entering or leaving a medium such as a semiconductor device. Dr. Zhao’s testimony merely repeats the disclosures in Usui and concludes, without further technical detail, explanation, or reference to objective evidence, that Usui’s Figure 8 discloses an electrode stack. Ex. 1002 ¶¶ 89–91. Dr. Zhao’s testimony sets forth Petitioner’s conclusory assertions as though they are facts, rather than setting forth facts and evidence in support of those assertions. Compare id. with Pet. 11–12. Absent underlying facts or evidence to support Dr. Zhao’s opinion, the cited testimony “adds little to the conclusory assertion for which it is offered to support, and is entitled to little weight.” Xerox Corp. v. Bytemark, Inc., IPR2022-00624, Paper 9 at 15 (PTAB Aug. 24, 2022) (precedential).” slip op. at 21

  Patent outcomesUS 8,686,562 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,686,562
• Luxottica Of America, Inc. v. E-Vision Smart Optics, Inc.Adverse judgment
  PTAB · Jun 29, 2026 · IPR2025-01512 · APJ Arthur M Peslak · IPR · Adverse judgment

  The Board granted Patent Owner’s request for adverse judgment, cancelled claims 1–27, and terminated the proceeding.

  RulingsAdverse judgment

  • Adverse judgmentAdverse judgmentGranted

    “A party may request entry of adverse judgment against itself at any time during an inter partes review proceeding. See 37 C.F.R. § 42.73(b). Under these circumstances, entry of judgment adverse to the Patent Owner is appropriate as to claims 1–27 of the ’612 patent. Consequently, we grant Patent Owner's request for adverse judgment.” slip op. at 2

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
  None
  Patents in suitUS 11,971,612

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