- 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 · GrahamPatents in suitUS 12,115,233 - Everstar Merchandise Co., Ltd. v. Willis Electric Co., Ltd.Some claims unpatentablePTAB · Dec 18, 2025 · PGR2019-00056 · APJ Stacey G White · PGR · Remand
Claims 2–7, 9–19, 21–25, 27, 30, 31, and 33 are unpatentable as obvious; Petitioner did not prove claims 8, 20, 26, 28, 29, and 32 unpatentable.
RulingsRemand decision- RemandMixed
“The Federal Circuit found that “[t]he factual record and Willis’s concession on appeal conclusively establish that the cost of copper was a known problem in the art, Debladis ’120 (and Kumada) helped address that issue, and Willis has not disputed that combining the teachings of Kumada and Debladis ’120 was within the skill of an ordinary artisan,” concluding “[n]othing more is required to establish a motivation to combine.” Everstar II, 2025 WL 1501940, 4. The Federal Circuit observed that “Willis has conceded that the combination of Kumada and Debladis ’120 disclose all the limitations in claim 1,” and accordingly, “reverse[d] the Board’s patentability determination as to that claim and vacate[d] the Board’s judgment as to the remaining claims of the ’037 patent,” remanding to us for further proceedings. Id. at 4–5. With those instructions in mind, we review the Petitioner’s allegations regarding claims 2–33.” slip op. at 6
- Skill levelSkill level board ownDecided for patent owner
“F. Person of Ordinary Skill in the Art In the First Final Written Decision, we determined that a person of ordinary skill in the art “would have (1) at least two years of experience in the design of decorative lighting, or (2) at least a bachelor’s degree in mechanical engineering, electrical engineering, or an equivalent field, and a basic familiarity with circuits used in decorative lighting.” Paper 40, 12. We see no reason to depart from that earlier determination.” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The parties agree that we do not need to construe any claim terms. Pet. 8–9; PO Resp. 16–17. We likewise agree. 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 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner
“Patent Owner did not dispute that the combined teachings of Kumada and Debladis ’120 disclose each limitation of claim 1. Patent Owner, however, did dispute Petitioner’s proposed reasons for combining Kumada and Debladis ’120, and argues that Debladis ’120 is not analogous art. PO Resp. 36–61. The Federal Circuit stated that substantial evidence only supports the conclusion that a POSA would have been motivated to combine the teachings of Kumada and Debladis ’120. The factual record and Willis’s concession on appeal conclusively establish that the cost of copper was a known problem in the art, Debladis ’120 (and Kumada) helped address that issue, and Willis has not disputed that combining the teachings of Kumada and Debladis ’120 was within the skill of an ordinary artisan. Nothing more is required to establish a motivation to combine. Given that Willis has conceded that the combination of Kumada and Debladis ’120 disclose all the limitations in claim 1, we reverse the Board’s patentability determination as to that claim and vacate the Board’s judgment as to the remaining claims of the ’037 patent. Everstar II, 2025 WL 1501940, 4 (internal citations omitted). The Federal Circuit further noted Patent Owner’s secondary considerations arguments as to claim 1 and stated [t]he cited evidence consists only of a temporal connection between the introduction of Willis’s invention and the UL 588 standards, and deposition testimony of a single witness who seemingly disclaimed any connection between the two. This is not sufficient to rescue a claim as to secondary considerations. Id. at 4, n. 5 (internal citations omitted). Accordingly, the Federal Circuit ruled that claim 1 would have been obvious over Kumada and Debladis ’120. 6. Analysis of Independent Claim 33” slip op. at 17
Patent outcomesUS 10,222,037 mixedClaim construction§ 103 obviousnesscites Phillips · KSRPatents in suitUS 10,222,037 - PTAB · Dec 12, 2025 · IPR2025-00763 · APJ Christopher L Ogden · IPR · Institution
The Board instituted IPR of claims 1–10 on all asserted grounds, finding a reasonable likelihood that Zeira alone or Zeira with Yi renders at least one challenged claim obvious.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“institute an inter partes review when “the information presented in the petition . . . and any response . . . shows that 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); see also 37 C.F.R. § 42.108(c). Applying that standard, we institute an inter partes review of all the challenged claims of the ’838 patent based on all grounds set forth in the Petition for the reasons explained below. This is a preliminary decision, and we will base our final written decision on the full trial record.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“had “a bachelor’s degree in electrical engineering, computer engineering, computer science, or a related field and at least two years of practical experience with design or development of telecommunication and/or wireless communications systems, or the equivalent.” Pet. 10 (citing Ex. 1003 ¶ 21). Patent Owner does not contest this at this stage. See Prelim. Resp. Petitioner’s proposed level of ordinary skill appears to be consistent with the problems addressed in the ’838 patent. See Ex. 1001, 1:30–2:48. Therefore, we adopt it for this decision.” slip op. at 6
- Expert testimonyPetitioner expert creditedDecided for petitioner
“person of ordinary skill in the art would have understood that Zeira’s RRC message includes MAC timer information. Zeira explicitly discloses that the calculated duration information is transmitted to the WTRU. Ex. 1005 ¶ 74. Zeira also discloses that information to “[c]onfigure the MAC layer” is transmitted to the WTRU in the form of an RRC message. Id. ¶ 423. Further, the duration is calculated while considering the amount of time that the MAC layer would need to transmit the current buffered data. Id. ¶ 76. Given these disclosures, we find sufficiently credible Dr. Lo’s testimony that a person of ordinary skill in the art would have understood Zeira to disclose that the RRC message received by the WTRU includes MAC timer information, and that the extent it does not, it would have been a predictable variation, at the time of the claimed invention, to implement a timer relating to the duration of network resources at the MAC layer as Yi teaches. Ex. 1003 ¶¶ 74–87, 107–113.” slip op. at 16
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner
“person of ordinary skill in the art would have understood that Zeira’s RRC message includes MAC timer information. Zeira explicitly discloses that the calculated duration information is transmitted to the WTRU. Ex. 1005 ¶ 74. Zeira also discloses that information to “[c]onfigure the MAC layer” is transmitted to the WTRU in the form of an RRC message. Id. ¶ 423. Further, the duration is calculated while considering the amount of time that the MAC layer would need to transmit the current buffered data. Id. ¶ 76. Given these disclosures, we find sufficiently credible Dr. Lo’s testimony that a person of ordinary skill in the art would have understood Zeira to disclose that the RRC message received by the WTRU includes MAC timer information, and that the extent it does not, it would have been a predictable variation, at the time of the claimed invention, to implement a timer relating to the duration of network resources at the MAC layer as Yi teaches. Ex. 1003 ¶¶ 74–87, 107–113.” slip op. at 16
§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,212,838 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · 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 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,643,462 - DISH Network LLC v. Entropic Communications, LLCSome claims unpatentablePTAB · Nov 14, 2025 · IPR2024-00373 · APJ Jon M Jurgovan · IPR · Remand
Claims 1, 4–8, and 10–16 are unpatentable under § 103; claims 2, 3, 9, and 17 were not shown unpatentable on any asserted ground.
RulingsRemand decision- RemandOther
“The Director then issued an Order, Paper 47 (“Director’s Order” or “Dir. Ord.”) granting Director Review, vacating-in-part the Final Written Decision, and remanding the case to this Board panel for proceedings consistent with the Order. The Director vacated-in-part the Final Written Decision because it did not sufficiently address Patent Owner’s arguments with respect to claim 17 (and similar claims 2 and 9). We have jurisdiction under 35 U.S.C. § 6. This Final Written Decision on Remand from Director Review is entered pursuant to 35 U.S.C. § 318(a). Having reviewed the complete trial record, we determine that Petitioner has shown, by a preponderance of the evidence, that the challenged claims are unpatentable except for claims 2, 3, 9, and 17.” slip op. at 3
- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. Level of Ordinary Skill in the Art The person of ordinary skill in the art is a hypothetical person who is” slip op. at 13
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“2. Analogous Art – DSL-Book A reference is analogous art to the claimed invention if: (1) the” slip op. at 75
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner
“4. Motivation to Combine Amit and Jacobsen Petitioner contends that a POSITA would have modified “Amit’s” slip op. at 31
Patent outcomesUS 7,594,249 mixed§ 103 obviousnesscites KSRPatents in suitUS 7,594,249 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · 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 · GrahamPatents in suitUS 11,325,974 - PLR Worldwide Sales Ltd. v. Flip Phone Games Inc.All claims unpatentablePTAB · Nov 5, 2025 · IPR2024-00133 · APJ Scott B Howard · IPR · Final written decision
Claims 1–10 are unpatentable as obvious over Sturman and Ho; the Board found the Ho/Jiau/Choi grounds, with and without Ellis, insufficient.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“We see very little difference between the parties’ respective proposals. We adopt Patent Owner’s marginally more specific proposal as it better reflects the ’089 patent. Additionally, because we would reach the same conclusions under Petitioner’s proposal, we agree with Patent Owner that this does not affect our analysis.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner
“Consistent with Phillips, we begin with the “ordinary and customary meaning” of the words of the claims. Phillips, 415. F.3d at 1312–13 (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)). The parties agree that the ordinary and customary meaning of the phrase “background object” is consistent with the dictionary definition and means an object that is “not in the foreground.” Tr. 8:10–16; PO Resp. 8–9; Ex. 2008 (AMERICAN HERITAGE DICTIONARY 2006); see also Ex. 2009 (“the scenery or ground behind something,” “the part of a painting representing what lies behind objects in the foreground”) (MERRIAM- WEBSTER DICTIONARY 2007); Ex. 2010 (“the part of a picture or pattern that is behind the main people or things in it” (MACMILLIAN ENGLISH DICTIONARY 2007); Ex. 2011 (“the ground or parts, as of a scene, situated in the rear (opposed to foreground)”) (RANDOM HOUSE WEBSTER’S COLLEGE DICTIONARY 2005). Having determined the ordinary and customary meaning, we need only look to see if there is some reason—such as the applicant acting as a lexicographer or the ordinary and customary meaning being improperly subjective—why the ordinary and customary meaning is not controlling.” slip op. at 15
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner
“We do not find that the prosecution history demonstrates that the applicant acted as a lexicographer by “clearly set forth a definition of the disputed claim term,” or “clearly express[ing] an intent to define the term” as required by Thorner, 669 F.3d at 1365. Instead, the language in the prosecution history is consistent with the ordinary and customary meaning. That is, the applicant focuses on the location of the object relative to the area of game play, i.e., the foreground. For example, the applicant distinguishes Chu’s object as not being “background objects” because they “are featured in the forefront of [the] game play as primary objects to be manipulated or used during game play (see Chu at ¶¶ [0063]–[0065]).” Ex. 1002, 85 (emphasis added).12 The applicant continued by arguing that Chu’s objects “exist in the background, outside of the primary focus of game play and as unexpectedly interactive components, and are not themselves needed or required in order to play the game.” Id. If anything, this demonstrates an intent of the applicant to use the customary and ordinary meaning—not in the foreground—and not act as a lexicographer.” slip op. at 17
- Expert testimonyPetitioner expert creditedDecided for petitioner
“We do not agree with Patent Owner’s argument. Under our rules, “[e]xpert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.” 37 C.F.R. § 42.65(a). We have reviewed Dr. Zagal’s testimony on this subject (see Ex. 1003 ¶¶ 156–160, 163, 166, 172, 177–178) and find that it complies with our requirements. Specifically, Dr. Zagal provides his opinion and identifies specific evidence in the record that supports it. We do not find MarkForged, a nonprecedential decision, persuasive. Although MarkForged cites 37 C.F.R. § 42.65(a) as support for the proposition that expert testimony “is entitled to little to no weight [if] it merely parrots the Petition,” the rule is silent on that point. Patent Owner has not directed us to any rule or precedential decision that says that non- 17 The decision was affirmed by the Director. Xerox Corp. v. Bytemark, Inc., IPR2022-00624, Paper 12 (PTAB Aug. 24, 2022). conclusory testimony which cites underlying factual support, such as Dr. Zagal gives in this proceeding, is entitled to no weight.” slip op. at 49
Patent outcomesUS 8,688,089 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,688,089 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · 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 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,325,975 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · 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 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,934,356 - PTAB · Oct 16, 2025 · PGR2025-00041 · APJ Justin T Arbes · PGR · Institution
The Board instituted PGR of claims 1–20 on all asserted grounds after finding claim 1 more likely than not obvious over Hendry.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“a post-grant review unless the information in the petition, if unrebutted, “would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” See 37 C.F.R. § 42.4(a) (“The Board institutes the trial on behalf of the Director.”). For the reasons that follow, we institute a post-grant review as to claims 1–20 of the ’243 patent on all grounds of unpatentability asserted in the Petition.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“a person of ordinary skill in the art would have had “at least a bachelor’s degree in computer science, electrical engineering, or a related field, and two years’ experience in data management or client-server systems and communications,” where “a higher education or skill level might make up for less experience, and vice-versa.” Pet. 6 (citing Ex. 1003 ¶¶ 35–39). Patent Owner did not file a Preliminary Response disputing Petitioner’s position. Based on the record presented, including our review of the ’243 patent and the types of problems and solutions described in the ’243 patent and cited prior art, we agree with Petitioner’s proposed definition of the level of ordinary skill in the art and apply it for purposes of this Decision, except that we remove the term “at least” to eliminate vagueness as to the amount of education and practical experience.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“any reasonable construction.” Pet. 7. Patent Owner did not file a Preliminary Response disputing Petitioner’s position. We conclude that no express interpretation of any claim term is necessary to determine whether to institute a post-grant review in this proceeding.4 See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“Because we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy,’ we need not construe [a particular claim limitation] where the construction is not ‘material to the . . . dispute.’” (citation omitted) (emphasis added)). 4 The parties, however, are encouraged to address during trial (1) interpretation of the term “user profile” in the challenged claims, particularly in view of the Specification’s apparent definition of the term “profile” (see Ex. 1001, col. 14, ll. 51–55) and description of exemplary data from which a “user profile” may be generated (id. at col. 18, ll. 40–58), and (2) the scope of the various instances of the phrase “in response to” in the challenged claims. Also, if either party intends to argue a claim interpretation during trial, including what the plain and ordinary meaning of a term is, the party should do so in a clearly designated section of its briefing. See Patent Trial and Appeal Board Consolidated Trial Practice Guide (Nov. 2019), 44–49, available at https://www.uspto.gov/ TrialPracticeGuideConsolidated; O2 Micro Int’l Ltd. v. Beyond Innovation Tech. Co., 521 F.3d 1351, 1361 (Fed. Cir. 2008) (“A determination that a claim term ‘needs no construction’ or has the ‘plain and ordinary meaning’ may be inadequate when a term has more than one ‘ordinary’ meaning or when reliance on a term’s ‘ordinary’ meaning does not resolve the parties’ dispute.”).” slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“each of its elements was, independently, known in the prior art.” KSR, 550 U.S. at 418. An obviousness determination based on a combination of references requires finding “both ‘that a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.’” Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367–68 (Fed. Cir. 2016) (quoting Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688 F.3d 1342, 1360 (Fed. Cir. 2012)); see also KSR, 550 U.S. at 418 (for an obviousness analysis, “it can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does”). Also, “[t]hough less common, in appropriate” slip op. at 8
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 12,039,243
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.