• Alliance Laundry Systems, LLC v. Payrange LLCSome claims unpatentable
  PTAB · Aug 19, 2026 · PGR2025-00027 · APJ George R Hoskins · PGR · Final written decision

  Claims 1–6 and 8–20 are unpatentable under § 101; claim 7 was not shown unpatentable.

  RulingsFinal written decision

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

    “Pet.”) pursuant to 35 U.S.C. §§ 321–329 to institute a post-grant review of U.S. Patent No. 11,966,920 B2 (Ex. 1001, “the ’920 patent”), claims 1–20. We issued an Institution Decision (Paper 12) granting the petitioned review. slip op. at 2

  • Skill levelOther

    “B. Level of Ordinary Skill in the Art Petitioner contends a person having ordinary skill in the art pertaining” slip op. at 11

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner

    “thereby supporting our conclusion that the plain and ordinary meaning of “affordance” in claim 1 refers to an interactive user interface element.” slip op. at 30

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

    “For the foregoing reasons, we conclude Petitioner’s reliance on Low’s” slip op. at 21

  Patent outcomesUS 11,966,920 mixed
  Claim construction§ 101 eligibility§ 103 obviousnesscites Alice · Mayo · Bilski · Berkheimer · Enfish · Electric Power · KSR
  Patents in suitUS 11,966,920
• Alliance Laundry Systems, LLC v. Payrange LLCSome claims unpatentable
  PTAB · Aug 19, 2026 · PGR2025-00028 · APJ George R Hoskins · PGR · Final written decision

  Claims 1–6 and 8–20 are unpatentable under § 102, § 103, or § 101; claim 7 was not shown unpatentable because the asserted grounds did not establish its limitations.

  RulingsFinal written decision

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed

    “1. Legal Standards “Anticipation requires that every limitation of the claim in issue be” slip op. at 10

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundMixed

    “2016) (alteration in original) (quoting Kinetic Concepts, 688 F.3d at 1368). Further, an assertion of obviousness “cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” KSR, 550 U.S. at 418 (quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)); accord In re NuVasive, Inc., 842 F.3d 1376, 1383 (Fed. Cir. 2016) (stating that “conclusory statements” amount to an “insufficient articulation[] of motivation to combine”; “instead, the finding must be supported by a ‘reasoned explanation’” (quoting In re Lee, 277 F.3d 1338, 1342 (Fed. Cir. 2002))); In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380 (Fed. Cir. 2016) (“To satisfy its burden of proving obviousness, a petitioner cannot employ mere conclusory statements. The petitioner must instead articulate specific reasoning, based on evidence of record, to support the legal conclusion of obviousness.”).” slip op. at 36

  • Patent Eligibility (§101) › Alice/Mayo step one — 'directed to'Step1 directed to exceptionMixed

    “because the “user interface” limitations merely apply the recited abstract idea on a generic mobile device without meaningfully limiting the abstract idea. See 2025 Guidance, at 4–5. For example, these limitations do not reflect an improvement to the functioning of the mobile device (or any other computer device), and instead are “mere instructions to implement an abstract idea or other exception on” the mobile device. Id. Indeed, the ’423 patent specification describes only a generic “swipe-to-pay” feature. See, e.g., Ex. 1001, 7:13–33, Figs. 8C, 10A–10D. This supports our conclusion here that the claim 11 limitations do not integrate the recited abstract idea into a practical application. See MPEP § 2106.04(d)(1) (“[T]he specification should be evaluated to determine if the disclosure provides sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement,” and “it must describe” slip op. at 108

  • Patent Eligibility (§101) › Alice/Mayo step two — inventive conceptStep2 no inventive conceptMixed

    “because the “user interface” limitations merely apply the recited abstract idea on a generic mobile device without meaningfully limiting the abstract idea. See 2025 Guidance, at 4–5. For example, these limitations do not reflect an improvement to the functioning of the mobile device (or any other computer device), and instead are “mere instructions to implement an abstract idea or other exception on” the mobile device. Id. Indeed, the ’423 patent specification describes only a generic “swipe-to-pay” feature. See, e.g., Ex. 1001, 7:13–33, Figs. 8C, 10A–10D. This supports our conclusion here that the claim 11 limitations do not integrate the recited abstract idea into a practical application. See MPEP § 2106.04(d)(1) (“[T]he specification should be evaluated to determine if the disclosure provides sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement,” and “it must describe” slip op. at 108

  Patent outcomesUS 11,972,423 mixed
  § 101 eligibility§ 102 anticipation§ 103 obviousnesscites Alice · Mayo · Bilski · Enfish · Electric Power · KSR · Graham
  Patents in suitUS 11,972,423
• Kubota North America Corporation v. Vermeer Manufacturing CompanyAll claims unpatentable
  PTAB · Jun 30, 2026 · IPR2025-00381 · APJ Eric C Jeschke · IPR · Final written decision

  Claims 1–10 are unpatentable: claims 1–8 and 10 are anticipated by KR996, and claim 9 is obvious over KR996 and Bares.

  RulingsFinal written decision

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

    “2. Independent Claim 1 Petitioner contends that KR996 both anticipates and renders obvious independent claim 1. Pet. 23–46. To support its arguments, Petitioner identifies certain passages in the cited references and explains the significance of each passage with respect to the corresponding claim limitation. Id. Patent Owner argues that KR996 does not disclose a “loader support” and thus fails to disclose limitations requiring “linkage[s]” and an “actuator” attached to the “loader support.” See PO Resp. 37–40; PO Sur-reply 20. In addition, Patent Owner presents evidence of objective indicia of nonobviousness. See PO Resp. 51–68; PO Sur-reply 23–27. We address each issue in turn. a. The Loader Support Limitations Claim 1 recites, in relevant part, “[1.3] a loader support having a first side and a second side . . . ; [1.5] a first linkage connected to the first side of the loader support . . . ; [1.6] a second linkage connected to the first side of the loader support . . . ; [1.7] a second actuator for raising the loader, the second actuator being connected to the loader support.” Ex. 1001, 6:56, 6:60–7:1 (collectively, the “loader support limitations”). As to the recitation of “a loader support having a first side and a second side,” Petitioner provides the following annotated version of Figure 9 of KR996: Pet. 30. In the annotated version of Figure 9 of KR996 above, Petitioner added (1) red text and arrows identifying a “loader support,” a “first side of loader support,” and a “second side of loader support” and (2) blue text identifying a “loader.” Id. Petitioner adds that “the loader support includes the portions of the frame of the KR996 vehicle that when in operation, support the attached loader unit 40 having loader arms of the booms 44.” Pet. 29. Petitioner also states that “KR996’s loader support includes the bracket to which the link 45 and boom cylinder 46 attach, as well as the frame protrusion, connected to the bracket, to which the forward link attaches.” Id. (citing Velinsky Pet. Decl. ¶ 72).” slip op. at 32

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

    “2. Dependent Claim 9 Petitioner contends that KR996, modified based on Bares, satisfies the additional limitations of claim 9. Pet. 60–69. To support its arguments, Petitioner identifies certain passages in the cited references and explains the significance of each passage with respect to the corresponding claim limitation. Id. Petitioner also articulates reasons to combine the relied-upon aspects of KR996 and Bares and explains why there would have been a reasonable expectation of success. Pet. 62–65. Patent Owner argues that one of ordinary skill in the art would not have had reason to combine KR996 and Bares. See PO Resp. 41–50; PO Sur-reply 22–23. Patent Owner also relies on its prior arguments that KR996 does not disclose the “loader support” limitations in independent claim 1. See PO Resp. 50. In addition, Patent Owner relies on the same evidence of objective indicia of nonobviousness discussed above. See PO Resp. 51–68; PO Sur-reply 21–27. We address each issue in turn. a. The Reasons to Combine KR996 and Bares Petitioner presents reasons why one of ordinary skill in the art would have combined KR996 and Bares and why the proposed combination would have had a reasonable expectation of success. See Pet. 62–65; Velinsky Pet. Decl. ¶¶ 157–162. After discussing why KR996 and Bares are analogous art to the claimed invention, Petitioner states that one of ordinary skill in the art “would have been motivated to combine the teachings of Bares with KR996 to produce a predictable and beneficial configuration of a tracked vehicle” in that “[t]he simple substitution of Bares’ track assembly for the wheels in the KR996 vehicle would have been predictable with a reasonable expectation of success that both KR996 and Bares relate to similar vehicle types with a similar mainframe having a drive mechanism attached thereto.” Pet. 63 (citing Velinsky Pet. Decl. ¶¶ 158–162). Petitioner asserts that “designing this vehicle type with a drive” slip op. at 64

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

    “probative and cogent evidence in the record” and “may often establish that an invention appearing to have been obvious in light of the prior art was not.” Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc., 699 F.3d 1340, 1349 (Fed. Cir. 2012). Thus, notwithstanding what the teachings of the prior art would have suggested to one skilled in the art, secondary considerations (objective evidence of non-obviousness) may lead to a conclusion that the challenged claims would not have been obvious. In re Piasecki, 745 F.2d 1468, 1471–72 (Fed. Cir. 1984). Our obviousness analysis includes consideration and weighing of Patent Owner’s objective indicia of non-obviousness. In order to accord substantial weight to secondary considerations in an obviousness analysis, “the evidence of secondary considerations must have a ‘nexus’ to the claims, i.e., there must be ‘a legally and factually sufficient connection’ between the evidence and the patented invention.” Henny Penny Corp. v. Frymaster LLC, 938 F.3d 1324, 1332 (Fed. Cir. 2019) (quoting Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387, 1392 (Fed. Cir. 1988)); Quanergy Sys., Inc. v. Velodyne Lidar USA, Inc., 24 F.4th 1406, 1417 (Fed. Cir. 2022). Although the patent owner bears the initial burden of proving a nexus (WMS Gaming Inc. v. Int’l Game Tech., 184 F.3d 1339, 1359 (Fed. Cir. 1999)), a presumption of nexus may be appropriate if the patent owner shows “the asserted objective evidence is tied to a specific product and that product ‘embodies the claimed features, and is coextensive with them.’” Polaris Indus, Inc. v. Arctic Cat, Inc., 882 F.3d 1056, 1072 (Fed. Cir. 2018) (quoting Brown & Williamson Tobacco Corp. v. Philip Morris Inc., 229 F.3d 1120, 1130 (Fed. Cir. 2000) (emphasis added)); Quanergy, 24 F.4th at 1417. On the other hand, “[w]hen the [product] is not coextensive with the patented invention—for example, if the patented invention is only a component of a commercially successful machine or process,” the patent owner is not entitled to a presumption of nexus. Demaco, 851 F.2d at 1392. A patent owner may establish nexus, either through (1) the use of a rebuttable presumption that arises when certain conditions are met or (2) a direct showing of nexus. In the first, a patent owner may rely on a rebuttable presumption of nexus as follows:” slip op. at 43

  • ExcludeMotion to exclude, grantedMotion to exclude, deniedGranted in part

    “2. Analysis “The moving party has the burden of proof to establish that it is entitled to the requested relief.” 37 C.F.R. § 42.20. Exhibit 1005 is an English language translation of Korean Patent No. 10-1041996. Exhibit 1006 is an English language translation of Japanese document JP2004-17705A. Exhibit 1014 is an English language translation of Korean Patent No. 10-1023528. A Certification of Translation signed by Takashi Maeshiro of HC Language Solutions, Inc., accompanies each of Exhibits 1005, 1006, and 1014. Ex. 1005 at 28; Ex. 1006 at 16; Ex. 1014 at 16. Each Certification of Translation is worded substantially the same except for the references to the document at issue and the source language being either Korean or Japanese. Exhibit 1005’s Certification of Translation, for example, states: I, Takashi Maeshiro, on behalf of HC Language Solutions, Inc., do solemnly and sincerely declare, to the best of my knowledge and belief, that the attached text represents a translation of Korean Patent No. 10-1041996, that the translation was performed by HC Language Solutions, Inc., and that the translation represents a true, correct, and faithful translation from Korean to English in a form that reflects the intention and meaning of the original text. I hereby declare that all statements made herein of my own knowledge are true and that all statements made on information and belief are believed to be true; and further that these statements were made with the knowledge that willful false statements and the like so made are punishable by fine or imprisonment, or both, under Section 1001 of Title 18 of the United States Code. Ex. 1005 at 28 (emphasis added).” slip op. at 17

  Patent outcomesUS 11,465,891 unpatentable
  § 102 anticipation§ 103 obviousnesscites Phillips · KSR
  Patents in suitUS 11,465,891
• Fluidmaster, Inc. v. Danco, Inc.Some claims unpatentable
  PTAB · Mar 5, 2026 · IPR2024-00634 · APJ Meredith C Petravick · IPR · Final written decision

  Claims 1, 3, 8–13, 15, 16, and 19–24 are unpatentable over Brown and Ho, with claims 16 and 19 also relying on the Quick Connection Art; the remaining challenged claims were not shown unpatentable.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “Patent Owner proposes that: A [person of ordinary skill in the art (“POSITA”)] in the field to which the ’105 Patent is directed would have had at least a Bachelor of Science degree in mechanical engineering or a related field or, as a substitute, at least two years of work or” slip op. at 9

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

    “of “integrally molded with” as “molded together as a single structure.” Paper 21, 15.” slip op. at 11

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

    “Patent Owner responds that: a POSITA would not have been motivated to make the proposed modification, nor does the Petition include any analysis regarding why a POSITA would be motivated to move from a vertical extended portion to a radial extended portion. Indeed, a radial extended portion is directly counter to the stated goals of Brown (e.g., reducing noise caused by turbulence), at least insofar as it introduces another sudden directional change into the fluid flow system. PO Resp. 58–59 (citing Ex. 2013 ¶ 242).” slip op. at 32

  • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner

    “Patent Owner argues that the ’105 patent claims were “fully supported as of the filing date of at least the ’606 Application . . . March 11, 2004” because the ’606 Application discloses regulating water flow and a POSITA would know that appropriate devices for regulating water flow includes nonadjustable waterflow restrictors. PO Resp. 63–65; PO Sur-reply 26–29. Patent Owner’s argument is persuasive. The ’606 Application discloses: [W]hen the toilet fill valve 100 is open and water flows from the water inlet 103 to the water outlets 106 and into a toilet tank, an amount of water is also supplied to the bowl fill valve inlet 113 that flows through the bowl fill valve 109 and out the bowl fill valve outlet 116. By virtue of the manual setting of handle 119 of the bowl fill valve 109, the flow of water through the bowl fill valve 109 is regulated. In this manner, the flow of water is regulated so that enough water flows out of the bowl fill valve 109 to fill a toilet bowl without wasting any water down a drain. seen from the passage above, the ’606 Application discloses regulating an amount of water supplied to a toilet bowl using a valve (i.e., a water flow regulator). Ex. 2013 ¶ 288. Further, the ’606 Application states: The bowl fill valve 109 may be, for example, a ball valve, a gate valve, a globe valve, a plug valve, a diaphragm valve, a butterfly valve, a needle valve, a sliding gate, a quick turn valve, a knife valve or any other appropriate type of valve as can be appreciated by those with ordinary skill in the art.” slip op. at 42

  Patent outcomesUS 9,103,105 mixed
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 9,103,105
• 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
• Fluidmaster, Inc. v. Danco, Inc.Some claims unpatentable
  PTAB · Dec 15, 2025 · IPR2024-00633 · APJ Meredith C Petravick · IPR · Final written decision

  Claims 1, 7–15, 19, and 20 are unpatentable over Brown and Ho; claims 2–6 and 16–18 were not shown unpatentable on the asserted grounds.

  RulingsFinal written decision

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable

    “Brown’s adapter tube 23 (i.e., the extended portion) does not extend radially from a longitudinal axis of valve assembly 13 (i.e., the toilet fill valve). Ex. 1021, Fig. 1. Mr. Jobin testifies that a POSITA would not be motivated to move adapter tube 23 from a vertical position to a radial position because “a radial extended portion is directly counter to the stated goals of Brown (e.g., reducing noise caused by turbulence), at least insofar system.” Ex. 2013 ¶ 251; see Ex. 1021, 1:9–62. Patent Owner’s argument is persuasive. Petitioner’s analysis and Dr. Cameron’s testimony is conclusory and does not sufficiently explain why a POSITA would be motivated to make the proposed modification to Brown. For example, Petitioner does not sufficiently explain how such a modification would result in a more compact toilet fill valve system that could be adapted to fit in more toilet tank designs. Further, neither Petitioner nor Dr. Cameron sufficiently address Mr. Jobin’s testimony regarding Brown’s desire for a quieter toilet. See Pet. Reply 23; Ex. 1036 ¶ 84. Petitioner fails to meet its burden to show by a preponderance of the evidence that claim 2 is unpatentable over Brown and Ho.” slip op. at 35

  • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner

    “description is an objective inquiry into the four corners of the specification from the perspective of a POSA. Using this test, the invention must be described in a manner sufficient to demonstrate that the inventor actually invented the claimed invention. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010). “One shows that one is ‘in possession’ of the invention by describing the invention, with all its claimed limitations, not that which makes it obvious.” Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997). Written description is a question of fact judged as of the relevant filing date. Falko–Gunter Falkner v. Inglis, 448 F.3d 1357, 1363 (Fed. Cir. 2006). An ipsis verbis disclosure, however, is not necessary to satisfy the written description requirement. Vas–Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991). The disclosure need only reasonably convey to a POSA that the inventor had possession of the subject matter in question, even if every nuance of the claims is not explicitly described in the specification. Id.; see Ariad, 598 F.3d at 1351. Patent Owner argues that the ’993 patent claims were “fully supported as of the filing date of at least the ’606 Application . . . March 11, 2004” because the ’606 Application discloses regulating water flow and a POSITA would know that appropriate devices for regulating water flow includes nonadjustable waterflow restrictors. PO Resp. 68; PO Sur-reply 28–30. Patent Owner’s argument is persuasive. The ’606 Application discloses: [W]hen the toilet fill valve 100 is open and water flows from the water inlet 103 to the water outlets 106 and into a toilet tank, an amount of water is also supplied to the bowl fill valve inlet 113 that flows through the bowl fill valve 109 and out the bowl fill valve outlet 116. By virtue of the manual setting of handle 119 valve 109 is regulated. In this manner, the flow of water is regulated so that enough water flows out of the bowl fill valve 109 to fill a toilet bowl without wasting any water down a drain. Ex. 1012, 47, ¶ 8 (emphasis added); see also Ex. 1001, 2:28–39. As can be seen from the passage above, the ’606 Application discloses regulating an amount of water supplied to a toilet bowl using a valve (i.e., a water flow regulator). Ex. 2013 ¶ 288.” slip op. at 48

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artNot shown unpatentable

    “1. Analysis of Claims 1–18 Schuster is available as prior art if the ’993 patent is only entitled to its January 27, 2014, filing date and not entitled to claim priority to earlier filing dates of the parent applications. On its face, the ’993 patent claims priority to a number of earlier parent applications, including Application No. 12/786,904 (the ’904 Application) filed May 25, 2010, and the Application code 63. Petitioner contends that the ’993 patent is not entitled to claim priority to the filing date of the earlier parent applications, and, thus, Schuster, a parent application of the ’993 patent, is available as prior art.15 Pet. 91–92. Petitioner alleges that the earlier parent applications, specifically Application No. 12/786,904 (the ’904 Application), do not provide written description support for the ’993 patent’s claim term “water flow regulator.” According to Petitioner, “water flow regulator” encompasses both adjustable devices for restricting the flow of water (i.e., valves) and fixed devices for restricting the flow of water (i.e., restrictors). Pet. 15. Petitioner contends that the ’904 Application does not provide support for water flow restrictors and, thus, does not provide support for the broader claim term water flow regulators. Id. at 14–15, 91–92. Petitioner argues that only adjustable water flow devices (i.e., valves) are supported by the ’904 Application. Id. Petitioner, thus, asserts that earliest effective filing date of the ’993 patent’s claims is the filing date of its application, January 27, 2014. Id. at 92. To be entitled to claim the benefit of an earlier filing date under 35 U.S.C. § 120 each application in the priority chain must comply with the written description requirement of 35 U.S.C. § 112(a). See Hollmer v. 14 The parties do not dispute that the ’993 patent and the earlier parent applications, including the ’904 Application and the ’606 Application, have the same pertinent portions of their specifications. See PO Resp. 71, n.16; Ex. 1004 ¶ 324. 15 Schuster issued on January 31, 2012, from Application No. 12/786,904, filed on May 25, 2010. Ex. 1029, code (21), (22), (45). Schuster, thus, issued more than one year prior to January 27, 2014.” slip op. at 46

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

    “2. Analysis of Claims 19 and 20 Claim 19 depends from claim 14 and additionally recites, “wherein the waterflow regulator comprises an adjustable water flow regulator that is configured to adjust the flow rate of the second portion of the water based at least in part on a setting of the adjustable water flow regulator.” Ex. 1001, 12:16–20. Claim 20 depends from claim 14 and recites the same additional limitation. Id. at 12:21–24. Claims 19 and 20, thus, require the water flow regulator to be an adjustable water flow regulator. Petitioner indicates that the earlier parent applications provide written description support for an adjustable water flow regulator. Pet. 91 (“[T]he ’904 application specification makes it clear that the adjustability of the bowl fill valve is a desirable and essential feature of the invention”); PO Surreply 28. Accordingly, Petitioner fails to meet its burden to show, by a preponderance of the evidence, that claims 19 and 20 are unpatentable over Schuster.” slip op. at 50

  Patent outcomesUS 9,139,993 mixed
  § 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 9,139,993
• 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
• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  PTAB · Nov 4, 2025 · IPR2024-00624 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 1–4, 6–10, and 12–15 are unpatentable, principally because the MSI-H Study Record anticipates them.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

    “Pet. 12 (citing Ex. 1003 ¶ 19). To Patent Owner, the ordinarily skilled artisan would have had a medical or graduate-level degree, or equivalent work experience, in the fields of immunology, genetics, or a related field and would have experience (i) conducting immunology research relating to oncology, (ii) conducting genetics research relating to oncology, or (iii) developing and conducting clinical trials on novel cancer therapies in those fields. PO Resp. 6 (citing Ex. 2072 ¶¶ 31–32, 86–94). Thus, Petitioner and Patent Owner characterize one of ordinary skill in the art differently. Petitioner emphasizes medical and treatment aspects in its characterization of an ordinarily skilled artisan, whereas Patent Owner emphasizes research aspects.” slip op. at 8

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

    “The parties do not assert constructions of any terms recited in the challenged claims other than that their ordinary and customary meanings should apply. Pet. 11–12; PO Resp. 6. We determine that no express construction of any claim term is necessary to resolve the dispute between the parties. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We construe” slip op. at 7

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

    “record, we are persuaded that the results recited in claim 1 would follow from the steps taught in the MSR, for the reasons and based on the evidence Petitioner cites above. For these same reasons, we are unpersuaded by Patent Owner’s argument that it was unknown whether the amount of pembrolizumab recited in claim 1 would be effective in producing an improved outcome compared to a reference patient without a tumor that was not MSI-H or dMMR, and Patent Owner does not dispute that the amount of pembrolizumab disclosed in the MSR (10 mg/kg every 14 days; see Ex. 1005, 4) is the same as the amount provided in the ’975 patent as being effective (10 mg/kg every 14 days; Ex. 1001, 8:48–52, 13:50–52). Regardless of the inventors’ intent in publishing the MSR as a Stage II clinical trial on the www.clinicaltrials.gov website, as discussed above, we determine that the MSR teaches selecting a patient with a metastatic MSI-H or dMMR tumor and administering an amount of pembrolizumab that would be effective. See, e.g., Ex. 1005, 4 (Arms and Interventions). The result of drug treatment inherently follows its administration. The MSR does not merely suggest that pembrolizumab may be useful in some unidentified subset of patients or suggest that some unidentified drug may be useful for MSI-H cancer patients. Instead, the MSR discloses selecting a patient with a condition recited in claim 1 and treating with the drug at the amount recited in claim 1. Contra Metabolite Labs. Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1367 (Fed. Cir. 2004) (holding that the prior art did not inherently anticipate where it failed to mention specific vitamin deficiencies, instead merely inviting further experimentation to find associations with metabolic perturbations). requirement, efficacy is inherent in carrying out the claim steps,” referring to a claimed method of treating or preventing stroke, which was held to be anticipated by the publication of a proposed study. 677 F.3d at 1381. Patent Owner attempts to distinguish the size and apparent surety of the study in Montgomery from the MSR. PO Resp. 15. But because we find that the MSR teaches performing the steps recited in claim 1 for the purpose of determining and treating MSI-H cancer, we are persuaded that the MSR inherently discloses the results of selection of patients and administration of the drug treatment recited in those steps. See Bristol-Myers, 246 F.3d at 1376. Whether or not the MSR could have provided results or was sufficient for full regulatory approval does not change that the MSR teaches Patent Owner’s claimed steps. We have no reason to doubt that the disclosure in the MSR of the steps recited in claim 1 produces the efficacy element required in claim 1, whether or not this efficacy was disclosed in the MSR or was known when it was published. See Mehl/Biophile, 192 F.3d at 1366 (“Where, as here, the result is a necessary consequence of what was deliberately intended, it is of no import that the article’s authors did not appreciate the results.”).” slip op. at 21

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

    “use that does not qualify as prior art. PO Resp. 18–25. Patent Owner argues that an inventor can be granted latitude to experiment in the public eye until her invention is ready for patenting. Id. at 18 (citing Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 64 (1998). According to Patent Owner, the experimental use negation applies to the MSR under a 13-factor analysis provided in Allen Engineering Corp. v. Bartell Industries, Inc., 299 F.3d 1336, 1353 (Fed. Cir. 2002). PO Resp. 19–25. For example, Patent Owner argues that to establish that treatment of MSI-H cancers was effective, the inventors had to test treatment in humans, there being no animal models, and had to publish the MSR on the government website under federal law. Id. at 20–22. Patent Owner argues further that the inventors had control over the MSI-H clinical study and that the field of cancer treatment was highly unpredictable, among other facts. Id. at 21. Patent Owner argues that “[a]t the time of the MSR’s posting, the claimed invention was not, nor could it have been, ready for patenting. The clinical study that ultimately collected the data reported in the patent specification and supporting the patent claims had not and could not have commenced before the MSR was posted.” Id. at 23. sometimes said that an inventor acquires an undue advantage over the public by delaying to take out a patent, inasmuch as he thereby preserves the monopoly to himself for a longer period than is allowed by the policy of the law,” but held that “when the delay is occasioned by a bona fide effort to bring his invention to perfection, or to ascertain whether it will answer the purpose intended,” the experiment use exception can preserve the inventor’s rights. City of Elizabeth v. Am. Nicholson Pavement Co., 97 U.S. 126, 137 (1877). Because we are not persuaded that Patent Owner could not have filed an earlier application, we are not persuaded that the experimental use doctrine is properly applied in this case. Given that clinical trial protocols published on the ClinicalTrials.gov website have been successfully asserted as prior art in other cases, we are not persuaded by Patent Owner’s arguments that the MSR is not available as prior art against the challenged claims. See, e.g., Salix Pharms., Ltd. v. Norwich Pharms. Inc., 98 F.4th 1056, 1061 (Fed. Cir.), cert. denied, 145 S. Ct. 567 (2024), and cert. denied, 145 S. Ct. 983 (2024).” slip op. at 24

  Patent outcomesUS 11,325,975 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,325,975
• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  PTAB · Oct 28, 2025 · IPR2024-00622 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 1–28 are unpatentable: claims 1, 6–11, 13–20, 22–24, and 26–28 as anticipated by the MSI-H Study Record; claims 2–5, 12, 21, and 25 as obvious.

  RulingsFinal written decision

  • BurdenUnpatentable

    “(“the claimed process here is not directed to a new use; it is the same use, and it consists of the same steps as described by [the prior art]. Newly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.”). After analysis of the full record, we are persuaded that the results recited in claim 1 would follow from the steps taught in the MSR, for the reasons and based on the evidence Petitioner cites above. For these same reasons, we are unpersuaded by Patent Owner’s argument that it was unknown whether the amount of pembrolizumab recited in claim 1 would be effective in producing an improved outcome compared to a reference patient without a tumor that was not MSI-H or dMMR, and Patent Owner does not dispute that the amount of pembrolizumab disclosed in the MSR (10 mg/kg every 14 days; see Ex. 1005, 4) is the same as the amount provided in the ’356 patent as being effective (10 mg/kg every 14 days; Ex. 1001, 8:48–52, 13:50–52). Regardless of the inventors’ intent in publishing the MSR as a Stage II clinical trial on the www.clinicaltrials.gov website, as discussed above, we determine that the MSR teaches selecting a patient with a metastatic MSI-H or dMMR tumor and administering an amount of pembrolizumab that would be effective. See, e.g., Ex. 1005, 4 (Arms and Interventions). The result of drug treatment inherently follows its administration. The MSR does not merely suggest that pembrolizumab may be useful in some unidentified subset of patients or suggest that some unidentified drug may be useful for MSI-H cancer patients. Instead, the MSR discloses selecting a patient with a condition recited in claim 1 and treating with the drug at the amount recited in claim 1. Contra Metabolite Labs. Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1367 (Fed. Cir. 2004) (holding that the prior art did not” slip op. at 22

  • Skill levelSkill level board ownDecided for petitioner

    “Petitioner and Patent Owner characterize one of ordinary skill in the art differently. To Petitioner, the ordinarily skilled artisan would have been a medical doctor, or a professional in a related field, with experience treating cancer or access to those with experience in clinical studies of therapeutics and to a pathologist with this experience. Pet. 11 (citing Ex. 1003 ¶ 19). To Patent Owner, the ordinarily skilled artisan would have had a medical or graduate-level degree, or equivalent work experience, in the fields of immunology, genetics, or a related field and would have experience (i) conducting immunology research relating to oncology, (ii) conducting genetics research relating to oncology, or (iii) developing and conducting clinical trials on novel cancer therapies in those fields. PO Resp. 5–6 (citing Ex. 2072 ¶¶ 31–32, 86–94). Petitioner emphasizes medical and treatment aspects in its characterization of an ordinarily skilled artisan, whereas Patent Owner emphasizes research aspects. The ’356 patent claims a method of treating a human patient with cancer having certain characteristics using pembrolizumab and the main prior art reference cited by Petitioner, MSR, discloses testing Ex. 1005. Accordingly, the relevant field of Patent Owner’s claims is treating human patients for cancer, as well as testing existing compounds for use in treatment modalities. 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 ’356 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

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

    “The parties do not assert constructions of any terms recited in the challenged claims other than that their ordinary and customary meanings should apply. Pet. 10–11; PO Resp. 6. We determine that no express construction of any claim term is necessary to resolve the dispute between the parties. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We construe claims “in accordance with the ordinary and customary meaning of such history pertaining to the patent.” 37 C.F.R. § 42.100(b) (2020).” slip op. at 8

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency foundUnpatentable

    “(“the claimed process here is not directed to a new use; it is the same use, and it consists of the same steps as described by [the prior art]. Newly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.”). After analysis of the full record, we are persuaded that the results recited in claim 1 would follow from the steps taught in the MSR, for the reasons and based on the evidence Petitioner cites above. For these same reasons, we are unpersuaded by Patent Owner’s argument that it was unknown whether the amount of pembrolizumab recited in claim 1 would be effective in producing an improved outcome compared to a reference patient without a tumor that was not MSI-H or dMMR, and Patent Owner does not dispute that the amount of pembrolizumab disclosed in the MSR (10 mg/kg every 14 days; see Ex. 1005, 4) is the same as the amount provided in the ’356 patent as being effective (10 mg/kg every 14 days; Ex. 1001, 8:48–52, 13:50–52). Regardless of the inventors’ intent in publishing the MSR as a Stage II clinical trial on the www.clinicaltrials.gov website, as discussed above, we determine that the MSR teaches selecting a patient with a metastatic MSI-H or dMMR tumor and administering an amount of pembrolizumab that would be effective. See, e.g., Ex. 1005, 4 (Arms and Interventions). The result of drug treatment inherently follows its administration. The MSR does not merely suggest that pembrolizumab may be useful in some unidentified subset of patients or suggest that some unidentified drug may be useful for MSI-H cancer patients. Instead, the MSR discloses selecting a patient with a condition recited in claim 1 and treating with the drug at the amount recited in claim 1. Contra Metabolite Labs. Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1367 (Fed. Cir. 2004) (holding that the prior art did not” slip op. at 22

  Patent outcomesUS 10,934,356 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 10,934,356

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.