• Berkshire Hathaway Energy Company / Pacificorp v. Birchtech Corp.Institution denied
  PTAB · May 20, 2026 · IPR2025-00423 · APJ Zhenyu Yang · IPR · Institution

  The Board denied institution of IPR challenging claims 1–4 and 6–29 because it instituted the ranked IPR2025-00422 under the Director’s instruction to maintain at most one IPR.

  RulingsInstitution decision

  • Parallel petitionsInstitution denied discretionary otherDenied

    “Paper 34. Birchtech Corp. (“Patent Owner”) filed a Request for Director Review in each case. See Paper 40; IPR2025-00422, Paper 39. The Director denied the request without prejudice in each case and remanded the cases to the Board to “allow discovery, narrowly tailored to resolve the RPI and privity issues.” Paper 49, 4. The Director later issued an Order Supplementing Director Review Decision in each case, instructing that “if the Board determines that Petitioners met their burden to identify all RPIs in the Petitions, then the Board should maintain at most one IPR challenging” the ’430 patent. Paper 72, 3.” slip op. at 2

  Discretionary denial
  Patents in suitUS 10,668,430
• Berkshire Hathaway Energy Company / Pacificorp v. Birchtech Corp.Institution denied
  PTAB · May 18, 2026 · IPR2025-00278 · APJ David Cotta · IPR · Institution

  The Board denied institution of Berkshire Hathaway Energy Company and PacifiCorp’s petition because it had instituted the earlier-filed IPR2025-00274 challenging the same patent.

  RulingsInstitution decision

  • PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner

    “request from Patent Owner for Director Review, finding that Patent Owner introduced “evidence sufficient to put RPI and privity at issue” and remanding with instructions to “allow discovery, narrowly tailored to resolve the RPI and privity issues” including “at least materials sufficient to clarify the evidence the Board found to be ‘ambiguous’ and to avoid the need for the Board to ‘speculate as to the nature of the redacted material.’” Paper 57 (Decision on Request for Director Review). The Director instructed that after allowing such discovery, we “should then determine on the full record whether Petitioners have met their burden of demonstrating that the Petitions are not time-barred under § 315(b), applying the framework set forth in Worlds Inc. v. Bungie, Inc., 903 F.3d 1237, 1242–44 (Fed. Cir. 2018). Concurrently herewith, we issue a decision in IPR2025- 00278 finding that Petitioner has met its burden of demonstrating that its Petition is not time-barred under 35 U.S.C. § 315(b).” slip op. at 2

  • Other 314aInstitution denied discretionary otherInstitution denied

    “Review Decision instructing that “if the Board determines that Petitioners met their burden to identify all RPIs in the Petitions, then the Board should maintain at most one IPR challenging each of the ’114 patent, the ’517 patent, the ’430 patent, and the ’225 patent.” Paper 79, 3. Together with its Petition in this proceeding and the proceeding in IPR2025-00274, Petitioner filed an Explanation Regarding the Necessity of Multiple Petitions. Paper 2 (“Explanation”); IPR2025-00274, Paper 2. In the Explanation, Petitioner “request[s] that, if the Board uses its discretion to institute the Petitions, the Board consider the merits of IPR2025-00274 . . . before IPR2025-00278.” Explanation, 3. Further to Petitioner’s request, we first considered the merits of IPR2025-00274. For the reasons discussed in our concurrently issued decision in IPR2025-00274, we institute inter partes review on the grounds set forth in the Petition in IPR2025-00274. Further to the Director’s instruction that we “maintain at most one IPR challenging . . . the ’114 patent,” and the Petitioner’s request that we consider the merits of IPR2025-00274 before IPR2025-00278, we deny institution of the Petition in this proceeding.” slip op. at 3

  Discretionary denial
  Patents in suitUS 10,343,114
• Penumbra, Inc. v. Rapidpulse, Inc.No claims unpatentable
  PTAB · Feb 17, 2026 · IPR2024-01261 · APJ Jamie T Wisz · IPR · Final written decision

  Claims 1–20 were not shown unpatentable because the asserted combinations did not teach the claimed predetermined cycle for controlling distal fluid flow.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “(1) a person with a B.S. in engineering or an equivalent field, with two-four years of academic or industry experience in aspiration embolectomy and thrombectomy or comparable industry experience who would, where appropriate, work or consult with others, including a physician, to develop embolectomy or thrombectomy devices; or (2) an interventional neurosurgeon with at least three years of experience developing and/or using medical devices in embolectomy or thrombectomy procedures, and who would, where appropriate, work or consult with others, including an engineer, to develop such a medical device. Pet. 11 (citing Ex. 1005 ¶ 48). Petitioner also contends that, “[a] person with less education but more relevant practical experience, or more relevant education but less practical experience, may also meet this standard.” Id. Patent Owner states that for purposes of its PO Response, it “accepts ¶ 44). We adopt Petitioner’s characterization because it is consistent with the level of skill in the art at the time of the invention as reflected by the ’402 patent and the cited prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 8

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

    “specification explicitly includes sensors similar to those in the prior art in support of their argument that the claimed “predetermined cycle” must not exclude the use of such sensors. Pet. Reply 15 (citing Ex. 1001, 32:55–33:7, 40:66–41:5, 44:9–29). We reviewed the portions of the specification cited by Petitioner. We agree with Patent Owner that one excerpt discussing sensor use appears to be directed to triggering the predetermined cycle rather than causing timing changes during the cycle itself (Ex. 1001, 32:55–66) (describing use of a pressure sensor to “determine when the vacuum channel 3 is clogged by a thrombus and automatically perform the unclogging procedures described herein”), while another excerpt discusses a sensor that Petitioner that the ’402 patent discusses the use of sensors to “tune” the system and that such “tuning” can be done statically (setting the cycle timing in advance) or dynamically (adjusting the timing during the cycle itself). See Ex. 1001, 48:19–49:50. Overall, we find that these disclosures involving sensors demonstrate that sensors may be used in various ways in different embodiments. However, none of these disclosures explicitly discuss the use of sensors in conjunction with a “pre-determined cycle.” Therefore, we find that the ’402 patent specification’s discussion of “sensors” are not particularly informative as to the appropriate construction of a “predetermined cycle” and do not outweigh the other explicit disclosures of “predetermined cycle” in the patent. We next turn to the other intrinsic evidence discussed by the parties — the prosecution history. As discussed by Patent Owner, in the Notice of Allowance, the Examiner found that Garrison did not teach or suggest a “predetermined cycle” because Garrison’s controller “changed the cycle of opening and closing the valves based on feedback from sensors.” Ex. 1004, 86. We acknowledge that the patent applicant filed subsequent comments during prosecution in which they stated that they “do[] not concede that the Examiner’s characterizations of the terms of the claims and the prior art are correct.” Id. at 29. However, we agree with Patent Owner that the importance of the Examiner’s statement in the Notice of Allowance does not rely on it being an express disclaimer (a standard which it does not meet). PO Sur-reply 8. We also considered Petitioner’s contention that the Examiner’s interpretation of Garrison may have been in error (PO Resp. 16); however, even if this were true, the Examiner’s statement still provides helpful insight into how the Examiner was interpreting the term sensors to change the opening and closing of valves during a cycle was not a “predetermined cycle.” Id. at 86. In sum, we find that Patent Owner’s proposed construction is consistent with the usage of the term “predetermined cycle” in the ’402 patent specification and prosecution history. Thus, after considering all of the cited evidence, we construe “predetermined cycle” to mean that “the timing of the sequence of valve operations in the cycle is determined beforehand, i.e., fixed, rather than varying based on feedback after operation begins.”” slip op. at 14

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

    “2. Other Terms The parties also provided proposed constructions for the limitations of “[limited/limiting] to a positive amount of exit flow” and “control[ling] fluid flow in and out from the distal end of the catheter.” See Pet. 15–16; Pet. Reply 1–8; PO Resp. 22–24; PO Sur-Reply 2–6. However, having evaluated the arguments and evidence before us, we determine that construction of these terms is not necessary for purposes of this Decision. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”)).” slip op. at 16

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableNot shown unpatentable

    “We agree with Patent Owner that neither Petitioner nor Mr. Brown propose any combination of Yang and Mullins that does not include Mullins’s pressure sensor in order “to control fluid flow in and out from the distal end of the catheter.” Indeed, in addressing the “predetermined cycle” limitation, Mr. Brown contends that Mullins discloses a “cycling controller that ‘varies aspiration pressure according to sensed pressure within the catheter lumen.’” Ex.1005 ¶¶ 131–32 (citing, e.g., Ex.1008, 27:40–28:20 (“[a] novel aspect of this pump system is the incorporation of feedback into the pump algorithm in order to produce more effective pressure cycling”)). This use of a sensor to change pressure during a cycle, is not a “predetermined cycle” under our construction. combinations is its discussion of distal end flow control, not for its sensors.” Pet. Reply 17 (citing Ex. 1035 ¶ 83). However, Petitioner’s obviousness grounds rely on the combination of Yang and Mullins, especially with regard to Mullins’s disclosure of “a controller” in order “to control fluid flow in and out.” As discussed above, Mullins relies on the sensor-feedback approach in order to control flow and we find that Petitioner has not presented persuasive evidence of how the combined disclosures of Yang and Mullins would control flow without using Mullins’s sensor feedback approach. See W.L. Gore & Assocs., Inc. v. Garlock, Inc., 721 F.2d 1540, 1550 (Fed. Cir. 1983) (error to “consider[] … references in less than their entireties, i.e., in disregarding disclosures in [them] … that diverge from and teach away from the invention”). Therefore, we determine that Petitioner has not sufficiently shown that the combination of Yang and Mullins discloses or renders obvious “a controller configured to open and close the vacuum valve and the vent valve in a predetermined cycle to change a level of vacuum at the distal end of the catheter and to control fluid flow in and out from the distal end of the catheter.” Accordingly, having considered the parties’ respective evidence and arguments, we find that Petitioner has not shown by a preponderance of the evidence that claim 1 of the ’402 patent would have been unpatentable as obvious over the combination of Yang and Mullins.” slip op. at 27

  Patent outcomesUS 11,406,402 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,406,402
• Pacificorp / Interstate Power & Light Company et al. v. Birchtech Corp.Other
  PTAB · Feb 10, 2026 · IPR2025-00687 · APJ Kristina M Kalan · IPR · Remand

  On remand, the Board instituted IPR on claims 1–8 and 10–18 over all asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.

  RulingsRemand decision

  • RemandInstituted

    “Paper 34, 1 (requesting “Director Review of the Director’s August 22, 2025 Decision Referring the Petition to the Board (‘Referral Decision’)”). Patent Owner argued that institution of IPR2025-00687 and IPR2025-00688 “should be discretionarily denied.” Id. at 5. Petitioner opposed. Paper 37. The Director granted review and found that “granting institution of two petitions that each challenge the same claims of the ’370 patent and ’218 patent 2” was an “abuse[] of discretion.” Paper 40, 1. The Director remanded the cases “to the Board panel to determine which of the two petitions challenging each of the ’370 and ’218 patents to institute.” Id. at 3. Pursuant to the Director’s instruction that we choose only one of the two petitions challenging the ’370 patent to institute, and for the reasons set forth below, we choose to institute review of the ’370 patent in this Petition, and not in IPR2025-00688.” slip op. at 3

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

    “the proceeding is filed more than 1 year after the date on which the petitioner, real party in interest, or privy of the petitioner is served with a complaint alleging infringement of the patent.” 35 U.S.C. § 315(b). Petitioner bears the burden of demonstrating compliance with 35 U.S.C. § 312(a)(2) and § 315(b). See, e.g., Ventex Co., Ltd. v. Columbia Sportswear N. Am., Inc., IPR2017-00651, Paper 152 (PTAB Jan. 24, 2019)” slip op. at 9

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC, Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995). Furthermore, the prior art itself can reflect the appropriate level of ordinary skill in the art. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 13

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

    “Petitioner “[does] not, at this time, contend that any term requires construction,” and instead, states that “[a]ll terms have been accorded their plain and ordinary meaning.” Pet. 11 (citing Ex. 1002 ¶¶ 212–215). Patent Owner asserts that it “does not presently propose any constructions,” but discusses the Board’s claim construction in IPR2020- 00834, Paper 18, 7–8. Prelim. Resp. 7. 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 14

  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR
  Patents in suitUS 10,933,370
• Pacificorp / Interstate Power & Light Company et al. v. Birchtech Corp.Other
  PTAB · Feb 10, 2026 · IPR2025-00717 · APJ Zhenyu Yang · IPR · Remand

  On remand, the Board instituted IPR of claims 1–4 and 6–26 on all six asserted obviousness grounds, finding a reasonable likelihood of prevailing.

  RulingsRemand decision

  • Director reviewDirector review, grantedOther

    “The Director granted Director Review, finding that the panel “abused its discretion in granting institution of two petitions that each challenge the same claims” of the ’218 patent. Paper 39, 2. The Director vacated the DI and remanded the case “to the Board panel to determine which of the two petitions” to institute. Id. at 4.” slip op. at 4

  • Parallel petitionsDecided for petitioner

    “On November 4, 2025, we instituted inter partes review of all challenged claims based on all the grounds raised in the Petition. Paper 35 (“DI”). In the DI, we noted that “Petitioner filed an explanation regarding the necessity of multiple petitions,” and “Patent Owner d[id] not challenge that multiple petitions are necessary” in the Preliminary Response. Paper 23, 3 n.3.” slip op. at 3

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

    “inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). For the reasons provided below, we determine Petitioner has satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Therefore, we institute inter partes review of all challenged claims based on all the grounds raised in this Petition.3” slip op. at 4

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner asserts that “[a] person of ordinary skill in the art [“POSITA”] would have at least a bachelor’s degree in chemical engineering, mechanical engineering, or a related field of study with at least two years of experience implementing pollution control in power generation plants for natural gas, coal, and/or industrial waste incineration.” Pet. 11 (citing Ex. 1002 ¶¶ 48–51). Patent Owner does not dispute the level of ordinary skill in the art. See generally Prelim Resp. For purposes of this Decision, we adopt Petitioner’s proposed definition of a POSITA because it is consistent with the skill level reflected in the disclosures of the ’218 patent and prior art. See Okajima, 261 F.3d at 1355 (the prior art may reflect an appropriate level of skill in the art).” slip op. at 10

  Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR
  Patents in suitUS 10,926,218
• Geneoscopy, Inc. v. Exact Sciences CorporationAll claims unpatentable
  PTAB · Feb 5, 2026 · IPR2024-01330 · APJ Ryan H Flax · IPR · Final written decision

  Claims 3, 4, and 12–19 are unpatentable as obvious under each asserted ground.

  RulingsFinal written decision

  • Skill levelOther
  • Expert testimonyOther
  • Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner

    “embody claims of the ’746 patent, the product has features not covered by the ’746 patent’s claims, some of which are critical unclaimed elements according to Patent Owner. Accordingly, Cologuard is not coextensive with the challenged claims, and no nexus between the product and the challenged claims is shown on this record.” slip op. at 35

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

    “developed where the patient need not manipulate their fecal sample to portion it, but the law of obviousness does not require an option to be the best option to be obvious. For these reasons, bearing in mind that the ultimate burden here is always on Petitioner, we are not persuaded by Patent Owner’s argument. We also reject Patent Owner’s argument that only impermissible” slip op. at 60

  Patent outcomesUS 11,970,746 unpatentable
  § 103 obviousnesscites Phillips · Graham
  Patents in suitUS 11,970,746
• Axion Biosystems, Inc. v. Agilent Technologies, Inc.No claims unpatentable
  PTAB · Feb 2, 2026 · IPR2024-01467 · APJ David Cotta · IPR · Final written decision

  Claims 1–8 and 11–15 were not shown unpatentable over Xu-752 and Jones because the proposed combination did not establish obvious millisecond time resolution.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “B. Level of Ordinary Skill in the Art Petitioner contends a person of ordinary skill in the art (“POSA”) as of May 2009 “would have had a B.S. in electrical/mechanical/biomedical engineering or biological science, or a related field, and approximately 2 years of relevant experience or equivalent study in systems and methods for bioanalysis of cells.” Pet. 14 (citing Ex. 1003 ¶¶ 23–25). Patent Owner adopts this definition for purposes of this proceeding. PO Resp. 9 (citing Ex. 2009 ¶ 19). We find Petitioner’s description of the level of ordinary skill in the art to be consistent with the level of skill reflected in the ’508 patent and in the prior art of record. Accordingly, we apply Petitioner’s definition in this decision.” slip op. at 7

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

    “As used herein, “impedance measurement at millisecond time resolution” refers to the ability to perform a series of at least two consecutive impedance measurements within milliseconds of one another for each and every well of the system where each well is associated with an electrode array for impedance measurement. In each instance the time between two consecutive impedance measurements are less than 300 milliseconds from one another. Id. at 10:8–15. There does not appear to be any dispute as to the definitional nature of the first sentence in the passage above. That is, the parties agree that millisecond time resolution should be construed to mean: “the time between two consecutive impedance measurements for each and every well being evaluated in the claimed apparatus or system.” PO Resp. 15 (proposing construction); Pet. Reply. 23 (“Axion also agrees that the term ‘millisecond time resolution’ is ‘the time between two consecutive impedance measurements for each and every well being evaluated in the claimed apparatus or system.’”). The parties also agree that we do not need to determine whether the time interval between two consecutive impedance measurements is less than 300 milliseconds, as set forth in the definition portion of the specification, or whether it can be met by some other time interval, as suggested by other portions of the specification. See e.g., Ex. 1001, 23:49–55 (explaining that “[i]n some embodiments 500 millisecond time resolution is sufficient”), 24:37–39 (similar); PO Resp. 15 (arguing that “the distinction between 300 milliseconds and 500 milliseconds is immaterial to the dispute in this IPR because Jones teaches a 1.5 second update period, thus at least three times longer than the 500 milliseconds formulation”); Pet. Reply 23–24 (section headed “[Petitioner] Agrees That, In This IPR, The 300 Versus 500 Milliseconds Distinction is Immaterial To Addressing the Unpatentability of the Challenged Claims”), see also, Pet. Reply 24–26 (asserting that the claims are indefinite because it is not clear whether they require a 300 or a 500 millisecond time interval, but arguing that “the claims’ unpatentability can be determined without resolving the 300 versus 500 milliseconds indefiniteness issue”). We agree with the parties that “millisecond time resolution” should be construed to mean: “the time between two consecutive impedance measurements for each and every well being evaluated in the claimed apparatus or system.” PO Resp. 15; Pet. Reply. 23. We further agree that resolution of this case does not require that we determine whether the period between two consecutive impedance measurements is less than 300 or less than 500 milliseconds because Petitioner has not carried its burden under either time interval.” slip op. at 7

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “Ex. 1003 ¶ 179. But Dr. Kim does not cite to any additional supporting evidence or provide any technical reasoning to support his statements. The notion that one can reduce the time between measurements by, e.g., reducing the number of frequencies measured, has intuitive appeal and appears mathematically correct. However, the absence of technical reasoning and supporting evidence diminishes the persuasiveness of Dr. Kim’s testimony that the POSA would made such modifications to reduce the time between measurements. Dr. Kim does provide some technical reasoning in connection with his discussion of eliminating all reference channels as a way to get the time resolution down to the levels required by, e.g., claim 14, which recites a millisecond time resolution of “less than 5 milliseconds.” See e.g., Ex. 1003 ¶ 172 (“A POSA seeking to study biological cell phenomena occurring on the order of a few milliseconds would have recognized that after measuring the reference network channels at the start, the reference network channels would not need measured again for some time, e.g., because temperature and other drift factors do not change appreciably on a millisecond time scale.”). However, even if we were to credit this testimony, Dr. Kim still lacks support and reasoning for the selection of the other parameters in his noreference-channel calculations. See, e.g., id. ¶ 173 (positing, but not providing technical reasoning for using, a no-reference-channel impedance system with 16 wells, a single 10kHz measurement frequency, and 16 daughter boards that measure simultaneously rather than sequentially).” slip op. at 29

  • Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightMotivation not foundNot shown unpatentableNot shown unpatentable

    “Given that Jones’s only exemplified embodiment targets a 1.5 second update period, that Jones does not suggest reducing the update period, and that much of Jones’s focus is on benefits other than speed of measurement, Jones’s impedance analyzer seems an unlikely choice for a POSA seeking to take measurements having millisecond time resolution. Put another way, we find no persuasive non-hindsight reason that supports Petitioner’s assertion that the POSA would have sought to apply Jones’s impedance analyzer to Xu-752’s system in order to take measurements in millisecond time resolution.” slip op. at 22

  Patent outcomesUS 11,906,508 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,906,508
• GE Healthcare Ltd. v. The Johns Hopkins UniversityInstituted
  PTAB · Jan 14, 2026 · PGR2025-00059 · APJ Devon Zastrow Newman · PGR · Institution

  The Board instituted post-grant review of claims 1–4 on all four asserted grounds, finding a sufficient preliminary showing of obviousness and lack of enablement.

  RulingsInstitution decision

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

    “V. CONCLUSION Petitioner has, at this stage, established that it will more likely than not prevail in showing that at least one of the challenged claims is unpatentable. This determination is, however, based on a preliminary record and is not final on any issues of patentability. We will make a final determination on the patentability of the challenged claims, as necessary and applying the preponderance of the evidence standard, based on a fully developed record through trial. VI. ORDER In consideration of the foregoing, it is hereby: ORDERED that, pursuant to 35 U.S.C. § 324(a) post grant review of claims 1–4 of the ’233 patent is hereby instituted on the grounds set forth in the Petition, commencing on the entry date of this Order, and pursuant to 35 U.S.C. § 324(d) and 37 C.F.R. § 42.4, notice is hereby given of the institution of a trial; and” slip op. at 40

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner does not proffer a description of a POSA. See generally, Prelim. Resp. For the purposes of this decision, on the record at this time, we find that Petitioner’s definition appears consistent with the level of skill shown in the prior art references of record, and apply it herein. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). We invite the parties to further address the definition of a POSA during trial should they find it necessary.” slip op. at 7

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “In addition, the opinion stated in the Pomper Declaration that “the term of ‘low molecular weight’ is well accepted in the chemical arts” and the declarant “recognize[s] that low molecular weight compounds would have a molecular weight of typically from about 50 Daltons to about 1,500 Daltons” is offered by a co-inventor. We, as factfinder, have discretion to weigh the credibility of expert witnesses and to give each item of evidence such weight as appropriate. See In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”). In this case, we find that the published references on metabolites do not support the opinion. In re Am. Acad. of Sci. Tech Ctr., 367 F.3d at 1368 (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”) US-121, of which Dr. Pomper is lead inventor, also uses the term “low molecular weight”—without further characterization of the term—and is uninformative as to the meaning of the term. See Ex. 1006, ¶ 12. In addition, Patent Owner’s definition does not appear to apply to all compounds claimed in US-121.5” slip op. at 11

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

    “limited to Patent Owner’s proposed “from about 50 Daltons to about 1,500 Daltons.” The cited evidence relied on in the Pomper Declaration to define “low molecular weight” as a term well accepted in the chemical arts relates to metabolomics and metabolites. See Ex. 1002, 169, (specifically, ¶ 17 of Dr. Pomper’s declaration). Patent Owner admits that Dr. Pomper’s testimony is about molecules that differ from the claimed imaging and radiotherapeutic agents targeting FAP-α, but argues that the testimony is still relevant for purposes of explanation. Prelim Resp. 21. While it may be relevant, the testimony is not persuasive in light of the Specification. We find the uncontested fact that several of the B moieties alone—without the A moiety or L linker—specifically identified in the ’233 patent fall outside of Patent Owner’s proposed definition persuasive, as we normally do not interpret claim terms in a way that excludes examples disclosed in the specification. See, e.g., Verizon Servs. Corp. v. Vonage Holdings Corp., 503 F.3d 1295, 1305 (Fed. Cir. 2007) (rejecting proposed claim interpretation that would exclude disclosed examples in the specification). The cases cited by Patent Owner supporting that a claim term may be construed to exclude embodiments where the prosecution history supports such construction are factually distinguishable from the instant case as they regard instances of specific prosecution history disclaimer, clear prosecution disavowal, or relate to a specific definition of the terms in the Specification for the term being construed. Here, “low molecular weight” is not defined in the Specification, but, as Petitioner argues (see Pet. 21–25) is characterized as “demonstrat[ing] faster pharmacokinetics and a higher specific signal within clinically convenient times after administration” and that it “can be synthesized in radiolabeled form more easily.” Ex.1001, 13:33–50, 14:56– 16:14, 17:9–20. We are persuaded by the testimony of Dr. Zeglis, Petitioner’s declarant, that compounds weighing over 1500 Da may share those same behaviors, along with certain identified B moieties disclosed as embodiments. See Ex. 1003 ¶ 83.” slip op. at 10

  Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 12,115,233
• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  PTAB · Nov 17, 2025 · IPR2024-00648 · APJ Devon Zastrow Newman · IPR · Final written decision

  Claims 1–30 are unpatentable: claims 1–2, 4–7, 9–12, 14–17, and 19–30 are anticipated by the MSI-H Study Record; claims 3, 8, 13, and 18 are obvious over the cited combinations.

  RulingsFinal written decision

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

    “We agree with Patent Owner that the phrase “in response to” in claim 1 requires a causal relationship wherein the patient must be tested for MSI-H and, if he or she is determined to be MSI-H or dMMR, then the patient is treated with 10 mg/kg of pembrolizumab every 14 days. In claim 1, a biological sample from the patient must be tested to determine if the cancer is MSI-H and, if so, the patient is treated with a therapeutically effective amount of pembrolizumab. For this reason, if the prior art teaches the limitations of 1) testing a biological sample obtained from a patient having cancer to determine that the patient’s cancer is microsatellite instability high or mismatch repair deficient, and 2) treating the patient with a therapeutically effective amount of pembrolizumab if the patient’s cancer is determined to be microsatellite instability high or DNA mismatch repair deficient, the art anticipates claim 1. We are not persuaded that claim 1 requires or excludes anything else because nothing else is recited in the claim.” slip op. at 10

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityReference is prior artDecided for petitioner

    “Patent Owner does not direct us to evidence that it attempted to file any patent application before the publication date of the MSI-H clinical study and was denied an earlier filing date. Contrary to Patent Owner’s argument that it could not file a patent application without results from the MSI-H clinical study, we note that the inventors filed a provisional patent application on November 13, 2014, which, although also filed more than a year after the publication of the MSI-H clinical study, disclosed no clinical results or data. Ex. 1001, cover; Ex. 1030, 1. After considering the parties’ arguments, we are not persuaded by Patent Owner’s assertion that the inventors could not have filed an earlier application to at least attempt to secure a priority date before the MSI-H clinical study was publicly available. an earlier filing date. Instead, we are persuaded by Petitioner’s argument that because the MSI-H clinical study was published before the inventors filed an application to protect their patent rights the MSI-H clinical study is prior art for the information it discloses. Accordingly, we proceed to analyze Petitioner’s contentions in Ground 1.” slip op. at 24

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

    “the genus disclosed in the MSI Study Record and does not argue or provide evidence to show that one of ordinary skill in the art could have envisaged each species within that genus. PO Resp. 11–14. We are not persuaded that either the size of the genus in the MSI Study Record or whether one of ordinary skill in the art would have been able to envisage every species within it is dispositive of whether the MSI Study Record anticipates claim 1, where one of ordinary skill in the art would have known that specific cancers recited in claim 1 would be included in the MSI Study Record. As Petitioner argues, claim 1 requires that “a patient…selected from the group consisting of [the listed cancers]” be tested and treated. Pet. Reply 10 (emphasis original). Claim 1 does not require that the patient have each and every one of the sixteen listed cancers to anticipate the claim. Rather, claim 1 requires testing a sample from “a patient” with one of the recited types of cancer and treating the patient. See Brown v. 3M, 265 F.3d 1349, 1351 (Fed. Cir. 2001) (“When a claim covers several structures or compositions, either generically or as alternatives, the claim is deemed anticipated if any of the structures or compositions within the scope of the claim is known in the prior art.”).” slip op. at 31

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “In contrast, the testimony of Patent Owner’s witness, Dr. Goldberg, supports Petitioner’s argument of the knowledge in the art at the time, wherein Dr. Goldberg testifies that “[w]hile many clinical oncologists were aware that patients with Lynch Syndrome had a defect in DNA mismatch repair, they associated MSI testing with young onset colorectal and endometrial cancer and patients with a family history of colorectal and/or endometrial cancer.” Ex. 2090 ¶ 79. Similarly, during his deposition, Dr. Goldberg also agreed that endometrial, gastric, and small-bowel cancers would come to mind when he saw a reference to MSI-high non-colorectal cancer. See Ex. 1243, 115:5–116:22 (Q. And so does endometrial cancer come to mind when you see reference to MSI-high non-colorectal cancers? . . . A. Yes. Q. As . . . a person of skill in the field, when you see reference to MSI-high non-colorectal cancers, does gastric cancer come to mind? . . . A. comes to mind. So the answer is yes. Q. As a person of skill in the field, when you see reference to MSI-high non-colorectal cancers, does small bowel cancer come to mind? . . . A. Yes.”). Patent Owner does not direct us to other evidence contradicting Petitioner’s argument that MSI-H was known to occur in endometrial, small bowel, and gastric cancer. Pet. 18.” slip op. at 30

  Patent outcomesUS 11,643,462 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,643,462
• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  PTAB · Nov 6, 2025 · IPR2024-00623 · APJ Devon Zastrow Newman · IPR · Final written decision

  Claims 1–7 are unpatentable: claims 1–3 and 5–7 are anticipated by the MSI-H Study Record, and claim 4 is obvious over the MSI-H Study Record and other cited references.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “On balance, we find Petitioner’s evidence more persuasive of what one of ordinary skill in the art would have understood from the MSI-H Study Record. We find Dr. Neugut’s and Dr. Oberstein’s testimony, and Dr. Lonberg’s lack of clear testimony to the contrary, persuasive as to this issue. In addition, we are not persuaded by the case law cited by Patent Owner regarding inherent anticipation. See PO Resp. 6–7. Rather, we agree with Petitioner that the correct inquiry is whether the skilled artisan would have understood that all limitations are disclosed in the prior art. See Pet. 34–35; Pet. Reply 12–13. In light of the cited testimony, we are persuaded that Petitioner has met its burden of proving that a skilled artisan would reasonably have understood or inferred that the limitation for a patient having received a prior cancer therapy drug to treat the tumor was disclosed in the MSI-Study Record. Petitioner demonstrates what one of ordinary skill in the art would have understood from the MSI-H Study Record, not what it inherently discloses. Contra PO Resp. 6–9.” slip op. at 22

  • Skill levelSkill level board ownDecided for petitioner

    “In light of the extent of the relevant field, we determine that the level of skill in the art relevant to the claims of the ’974 patent is not limited to knowledge of and experience with conducting research relating to oncology or developing and conducting clinical trials, but includes knowledge of and experience with treating cancer patients with immunotherapy compounds, identifying the conditions these patients may have, and understanding the literature regarding clinical trials for such colorectal cancers and the associated conditions and immunotherapy.” slip op. at 9

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable

  Patent outcomesUS 11,325,974 unpatentable
  § 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,325,974

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.