• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  PTAB · Sep 23, 2025 · IPR2024-00649 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 1–28 are unpatentable: claims 1, 2, 4–7, 9–12, 14–17, and 19–28 are anticipated by the MSI-H Study Record; claims 3, 8, 13, and 18 are obvious.

  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 9

  • Skill levelSkill level board ownOther

    “In the Decision to institute trial, we adopted Petitioner’s uncontested proposal defining that the level of skill in the art, presented above. Inst. Dec. 7. Neither party directs us to evidence of the level of skill in the art beyond what we considered for institution of trial. Having considered Patent Owner’s positions and evidence of record, however, we determine that the level of skill also 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 cancers and the associated conditions and immunotherapy.” slip op. at 15

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

    “holding is limited to anticipation of a claimed genus through disclosure of individual species, whereas the facts of this case involve the disclosure of a genus. PO Resp. 14. Because the facts before us, including the testimony of Patent Owner’s witness, indicate that one of ordinary skill in the art would have immediately understood that the third arm of the study described in the MSR includes patients with cancers recited in claim 1, including endometrial, gastric, and small-bowel cancers, we are persuaded that one of ordinary skill in the art would have understood that the MSR discloses species that fall within the scope of claim 1. Ex. 2090 ¶ 79; Ex. 1243, 115:5–116:22; Ex. 1085, 673–75; Ex. 1086, 14; Ex. 1003 ¶¶ 25, 63; Ex. 1005, 4. We are not persuaded that where species falling within the scope of claim 1 were previously known and disclosed in MSR, that claim 1 is patentable over the MSR. See Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381 (Fed. Cir. 2015) (“a reference can anticipate a claim even if it ‘d[oes] not expressly spell out’ all the limitations arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’” the claimed arrangement or combination.” (quoting In re Petering, 301 F.2d 676, 681 (CCPA 1962)). After considering the parties’ arguments and the evidence presented, we are persuaded that the MSR teaches “testing or having tested a biological sample obtained from a patient” having endometrial, small bowel, or gastric cancer and, thus teaches the corresponding limitation of claim 1.6” slip op. at 29

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

    “Regarding the dependent claims that Petitioner challenges only on obviousness grounds (claims 3, 8, 13, 18), Patent Owner must show a nexus between the claimed methods and the evidence of non-obviousness. See Henny Penny Corp. v. Frymaster LLC, 938 F.3d 1324, 1332 (Fed. Cir. 2019) (“to be accorded substantial weight in the 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. . . . Ultimately, ‘[t]he patentee bears the burden of showing that a nexus exists.’” (quoting Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387, 1392 (Fed. Cir. 1988), WMS Gaming, Inc. v. Int'l Game Tech., 184 F.3d 1339, 1359 (Fed. Cir. 1999)). Patent Owner does not direct us to evidence of a nexus to limitations recited in the dependent claims, for example to claims 3 and 13, which recite testing a biological sample that is a bodily fluid, claims 8 and 18, which recite testing that comprises assessing one or more markers selected from the group consisting of BAT-25, BAT-26, MONO-27, NR-21 and NR-24. Even if there is a nexus to the Patent Owner’s evidence of secondary considerations, the evidence addresses the methods of independent claims 1 and 11, not the limitations of the claims Petitioner challenges as being obvious. PO Resp. 55–83. Patent Owner directs us only to evidence regarding treating patients determined to have certain MSI-H cancers with pembrolizumab, which we determine to be anticipated by the MSR. Id. at 58. When evidence of a “secondary consideration is exclusively related to a single feature that is in the prior art,” our reviewing court has held the evidence is of no relevance to the obviousness inquiry. See Yita LLC v. MacNeil IP LLC, 69 F.4th 1356, 1363–65 (Fed. Cir. 2023), cert. denied, 144 S. Ct. 499 (2023) (distinguishing WBIP, LLC v. Kohler Co., 829 F.3d 1317, 1330–31 (Fed. Cir. 2016)); see also Ethicon Endo-Surgery, Inc. v. Covidien LP, 812 F.3d 1023, 1034 (Fed. Cir. 2016) (“[I]f the feature that creates the commercial success was known in the prior art, the success is not pertinent.”). In Yita, the prior art taught close-conformance of a floor tray with the walls of a vehicle foot well, which one of ordinary skill in the art would have had reason to use in combination with other prior-art teachings to arrive at the claimed invention. See Yita, 69 F.4th at 1359–61. The court held that because the asserted evidence of secondary consideration related exclusively to close-conformity, the evidence was not persuasive of non-obviousness, even though the claimed floor tray was coextensive with the product that produced the evidence. See id. at 1364–65 (“The coextensiveness inquiry bears only on the presumption of nexus; it does not decide the overall nexus question.”). Because Patent Owner directs us only to evidence that the methods recited in claims 1 and 11 produced evidence of secondary considerations, we are not persuaded that this evidence is persuasive of the non-obviousness of the specific methods recited in the dependent claims. For example, Patent Owner fails to direct us to evidence that a method of treating MSI-H colorectal cancer in a patient “wherein the biological sample is a body fluid from the patient,” as recited in claim 3, or “wherein the at least one marker comprises BAT-25, BAT-26, MONO-27, NR-21 or NR-24,” as recited in claim 8, demonstrated unexpected results or commercial success. Accordingly, having considered the evidence of record as a whole, we determine that Petitioner has demonstrated by a preponderance of the evidence that the methods of claims 3, 8, 13, and 18 would have been obvious. We are not persuaded to the contrary by Patent Owner’s arguments or evidence of second secondary considerations.” slip op. at 47

  Patent outcomesUS 11,629,187 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,629,187
• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  PTAB · Sep 23, 2025 · IPR2024-00647 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 1–36 are unpatentable: claims 1–2, 4–8, 11–12, 14–18, and 21–36 as anticipated, and claims 3, 9, 10, 13, 19, and 20 as obvious.

  RulingsFinal written decision

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided 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 colorectal cancer to determine that the patient’s colorectal 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 colorectal 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 9

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “The ’287 patent claims a method of treating a human patient with colorectal cancer having certain characteristics using pembrolizumab and the main prior art reference cited by Petitioner discloses testing pembrolizumab to treat human patients. See Ex. 1001, 24:42–52; Ex. 1005. Accordingly, the relevant field of Patent Owner’s claims is treating human patients, as well as testing existing compounds. In the Decision to institute trial, we adopted Petitioner’s uncontested proposal defining that the level of skill in the art, presented above. Dec. 7– 8. Neither party directs us to evidence of the level of skill in the art beyond what we considered for institution of trial. Having considered Patent Owner’s positions and evidence of record, however, we determine that the level of skill also 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 cancers and the associated conditions and immunotherapy.” slip op. at 14

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “In an anticipation analysis, the dispositive question is whether a skilled artisan would ‘reasonably understand or infer’ from a prior art reference that every claim limitation is disclosed in that single reference.” Acoustic Tech., Inc. v. Itron Networked Sols., Inc., 949 F.3d 1366, 1373 (Fed. Cir. 2020). Extrinsic evidence, such as declarations and depositions may be considered when it is used to explain, but not expand, the meaning of a reference. See In re Baxter Travenol Labs., 952 F.2d 388, 390 (Fed. Cir. 1991) (holding that the depositions and declarations of skilled workers were properly used to show what those skilled in the art would have known about the prior art). We credit Dr. Neugut’s and Dr. Oberstein’s testimony about what one of ordinary skill in the art would have understood after reviewing the MSR. slip op. at 34

  Patent outcomesUS 11,649,287 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,649,287
• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  PTAB · Sep 19, 2025 · IPR2024-00650 · APJ Deborah Katz · IPR · Final written decision

  Claims 1–38 are unpatentable: claims 1, 2, 4–7, 11–17, 19–22, and 26–38 are anticipated by the MSR; the remaining claims are obvious over the MSR and cited references.

  RulingsFinal written decision

  • 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 be 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. (See 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. (See PO Resp. 5–6 (citing Ex. 2072 ¶¶ 31–32, 91–99).) Petitioner emphasizes medical and treatment aspects in its characterization of an ordinarily skilled artisan, whereas Patent Owner emphasizes research aspects. The ’491 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 discloses testing pembrolizumab to treat human patients. (See Ex. 1001, 25:36–52, 26:24–41, Ex. 1005; see Decision 8–9.) Accordingly, the relevant field of Patent Owner’s claims is treating human patients, as well as testing existing compounds. 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 ’491 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. C. Claim Construction” slip op. at 8

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “Dr. Lonberg, Patent Owner’s witness, does not dispute any of Dr. Neugut’s or Dr. Oberstein’s testimony, but asserts only that Dr. Neugut’s testimony relies only on what was generally done, not on what is expressly disclosed in the MSR. (See Ex. 2072 ¶¶ 105–107.) On cross-examination, Dr. Lonberg agreed with Dr. Oberstein that patients who had received prior cancer therapy were not excluded from the study described in the MSR. (See Ex. 1245, 57:5–58:2, 40:5–14, 49:2–12.) Thus, after considering the evidence cited by each party, we find Dr. Neugut’s and Dr. Oberstein’s testimony to be the most directly relevant and persuasive about what one of ordinary skill in the art would have understood from the MSR itself. We are also persuaded by the lack of a specific contradiction regarding the understanding of one of ordinarily skill in the art by Dr. Lonberg. Even if some patients who had been previously treated with specific drugs were excluded from the study described in the MSR, we are persuaded that one of ordinary skill in the art would have understood the MSR as including other patients who have been treated with a prior cancer therapy drug. We are persuaded that Petitioner has met its burden of proving whether a skilled artisan would reasonably understand or infer that the limitations of claims 13, 28, 32, and 36 were disclosed in the MSR. Petitioner demonstrates what one of ordinary skill in the art would have understood from the MSR, not what it inherently discloses. (Contra PO Resp. 19–22.)” slip op. at 38

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

    “Patent Owner argues that the “in response to” limitation of claim 1 describes administering the claimed treatment only to patients determined to have an MSI-H tumor. (See PO Resp. 6.) But neither claim 1 nor claim 16 includes a limitation excluding the treatment of any patient, such as specifically excluding treatment of any patient who has a tumor that is not MSI-H or dMMR. Neither claim 1 nor claim 16 recites any language differentiating between patients or identifying a patient population to be excluded from treatment. Instead, claims 1 and 16 provide that if the colorectal cancer patient is tested and the cancer is determined to be MSI-H or dMMR, the patient is treated with a therapeutically effective amount of pembrolizumab. We note that the methods of claims 1 and 16 use the open-ended transitional phrase “comprising” that is generally interpreted to not exclude additional, unrecited elements. See Invitrogen Corp. v. Biocrest Mfg., L.P., 327 F.3d 1364, 1368 (Fed. Cir. 2003) (“The transition ‘comprising’ in a method claim indicates that the claim is open-ended and allows for additional steps.”); Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501 (Fed. Cir. 1997) (“‘Comprising’ is a term of art used in claim language that means that the named elements are essential, but that other elements may be added and still form a construct within the scope of the claim.”). The use of the open-ended transitional phrase “comprising” in claims 1 and 16 further suggests to us that any additional steps taken in conjunction with expressly recited method steps, such as the treatment of patients who are not MSI-H or dMMR, are not excluded from the scope of the claim.” slip op. at 13

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

    “discloses species that fall within the scope of claim 1. (See Ex. 2090 ¶ 79; Ex. 1243, 115:5–116:22; Ex. 1085, 673–75; Ex. 1086, 14; Ex. 1003 ¶¶ 25, 67; Ex. 1005, 4.) We are not persuaded that where species falling within the scope of claim 1 were previously known and disclosed in MSR, that claim 1 is patentable over the MSR. See Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381 (Fed. Cir. 2015) (“a reference can anticipate a claim even if it ‘d[oes] not expressly spell out’ all the limitations arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’” the claimed arrangement or combination.” (quoting In re Petering, 301 F.2d 676, 681 (CCPA 1962)). After considering the parties’ arguments and the evidence presented, we are persuaded that the MSR teaches “testing or having tested a biological sample obtained from a patient” having endometrial, small bowel, or gastric cancer and, thus teaches the corresponding limitation of claim 1. d) Element [1.3]: “thereby determining that the patient’s cancer is” slip op. at 26

  Patent outcomesUS 11,634,491 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,634,491
• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  PTAB · Sep 18, 2025 · IPR2024-00625 · APJ Deborah Katz · IPR · Final written decision

  Claims 1–8 are unpatentable: claims 1–4 and 6–8 are anticipated by MSR, and claim 5 is obvious over MSR with the additional marker-testing teachings of Chapelle.

  RulingsFinal written decision

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

    “In an anticipation analysis, the dispositive question is whether a skilled artisan would ‘reasonably understand or infer’ from a prior art reference that every claim limitation is disclosed in that single reference.” Acoustic Tech., Inc. v. Itron Networked Sols., Inc., 949 F.3d 1366, 1373 (Fed. Cir. 2020). Extrinsic evidence, such as declarations and depositions may be considered when it is used to explain, but not expand, the meaning of a reference. See In re Baxter Travenol Labs., 952 F.2d 388, 390 (Fed. Cir. 1991) (holding that the depositions and declarations of skilled workers were properly used to show what those skilled in the art would have known about the prior art). Although Patent Owner argues that a missing element cannot be filled by what an ordinarily skilled artisan would have envisioned, Petitioner’s argument is based on what one of ordinary skill in the art would have understood from what the MSR expressly teaches. (See Pet. 20 (“Indeed, prior art concerning the MSI-H Study indicates that the physicians understood postings on clinicaltrials.gov indicated that patients had ‘metastatic tumors.’ (EX1049, 444; see also EX1050, S4; EX1003, ¶62.)”).) Unlike the facts of Nidec, where a missing signal could have been envisioned but was not present, we are persuaded by the evidence Petitioner presents that those of ordinary skill in the art understood the MSR express disclosure to include patients with unresectable or metastatic tumors because references referring to the study underlying the MSR discuss the inclusion of patients with metastatic tumors in the study. Even if Dr. Neugut’s reasoning that the reference to “measurable” disease in the MSR would have indicated patients having metastatic cancer is flawed, we are persuaded by Petitioner’s evidence of publications referring to the MSR as a study of metastatic colorectal cancer, and we are further persuaded that one of ordinary skill in the art would have understood the MSR to disclose treating patients having metastatic colorectal cancer with pembrolizumab. (See Ex. 1049, 444, Ex. 1050, S4.) Patent Owner does not address this evidence. Instead, Patent Owner acknowledges that “the MSR discloses treating cancer patients that could be within the claimed subset,” but argues that the MSR does not inherently anticipate results later obtained by treating only patients within the claimed subset. (See Pet. Sur- Reply 5–6.) We are persuaded, though, that Petitioner’s challenge is based on what one of ordinary skill in the art would have understood from the MSR (that patients who had an unresectable or metastatic tumor were selected), not on what is inherent to the disclosure of the MSR. We are persuaded that one of ordinary skill in the art at the time would have understood the MSR to teach selecting a patient “who has an unresectable or metastatic,” as required in claim 1. c) Element 1.2: “microsatellite instability-high (MSI-H) or mismatch slip op. at 14

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

    “Patent Owner argues further that the MSR discloses an experimental use that does not qualify as prior art. (See PO Resp. 16–23.) Patent Owner argues that an inventor can be granted latitude to experiment in the public eye until her invention is ready for patenting. (See id. at 16 (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 Eng'g Corp. v. Bartell Indus., Inc., 299 F.3d 1336, 1353 (Fed. Cir. 2002). (See PO Resp. 17–23.) 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. (See PO Resp. 18–20.) 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. (See id. at 19–20.) 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 21.) In City of Elizabeth, the Supreme Court was concerned that “[i]t is 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). After considering the parties’ arguments and evidence, we are” slip op. at 24

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

    “In order to show that objective evidence renders the method of claim 5 non-obvious, Patent Owner must show a nexus between the subject matter recited in claim 5 and the evidence of non-obviousness. See Henny Penny Corp. v. Frymaster LLC, 938 F.3d 1324, 1332 (Fed. Cir. 2019) (“to be accorded substantial weight in the 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. . . . Ultimately, ‘[t]he patentee bears the burden of showing that a nexus exists.’” (quoting Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387, 1392 (Fed. Cir. 1988), WMS Gaming, Inc. v. Int'l Game Tech., 184 F.3d 1339, 1359 (Fed. Cir. 1999)). Patent Owner argues that there is a nexus between the development and commercialization of pembrolizumab and the patented method of treatment recited in the challenged claims, citing, inter alia, the package insert for Keytruda® (pembrolizumab), but Patent Owner does not direct us to evidence of a nexus to MSI-H or MMR deficient tumors that exhibit instability in the microsatellite markers recited in claim 5 and the unexpected results, commercial success, or other objective measures of non-obviousness flowing from these additional limitations. (See PO Resp. 50–63 (citing Ex. 2129, Ex. 2072 ¶ 190, Ex. 2090 ¶¶ 82–92).) Patent Owner directs us only to evidence regarding determining MSI-H status and then using Keytruda® to treat MSI-H cancer patients, which we determine to be anticipated by the MSR. (See PO Resp. 60.) When evidence of a “secondary consideration [] is exclusively related” slip op. at 34

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

    “(Ex. 1001, 26:19–28.) In Grounds 3 and 5, Petitioner argues, relying on Dr. Neugut’s testimony, that Chapelle teaches standard methods of testing whether a tumor is MSI-H, including determining whether the patient’s tumor exhibits instability in a microsatellite marker, such as BAT-25 or BAT-26. (See Pet. 42 (citing Ex. 1007, 3380, 3383; Ex. 1003 ¶ 107).) For example, Chapelle states that “‘a standard test’ using a ‘[p]anel consisting of … BAT26, BAT25’ has ‘stood the test of time.’” (Ex. 1007 at 3382.) Dr. Neugut testifies that one of ordinary skill in the art would have been motivated to treat a patient with an unresectable or metastatic MSI-H dMMR tumor, wherein the tumor exhibits instability in the BAT-25 and BAT-26 microsatellite marker, and would have expected success in doing so, in light of the teachings of Chapelle. (See Ex. 1003 ¶¶ 105–108.) We find that the record as recounted above supports Petitioner’s challenges of claim 5 in Grounds 3 and 5.” slip op. at 31

  Patent outcomesUS 11,339,219 unpatentable
  § 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,339,219
• Revvo Technologies, Inc. v. Cerebrum Sensor Technologies, Inc.Instituted
  PTAB · Sep 15, 2025 · IPR2025-00632 · APJ Mitchell G Weatherly · IPR · Institution

  The Board instituted IPR on all challenged claims and grounds, finding a reasonable likelihood that claims 1, 2, 7–9, 11, 12, and 20–24 are obvious over Yamaguchi-727.

  RulingsInstitution decision

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

    “Cerebrum Sensor Technologies, Inc. (“Patent Owner”) timely filed a Preliminary Response. Paper 9 (“Prelim. Resp.”).1 Institution of an inter partes review is authorized by statute when “the information presented in the petition filed under section 311 and any response filed under section 313 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). Based on our review of the record, we conclude that Petitioner is reasonably likely to prevail with respect to at least one of the challenged claims.” slip op. at 2

  • BurdenInstituted

    “We disagree. Positioning module 6 to face a “predetermined direction” is a form of preventing movement that falls within the scope of limitation 1b. Moreover, Yamaguchi-727 uses a method for preventing movement of its module 6 in its housing 20, silicone potting material, that is expressly recognized by the Specification of the ’421 patent when it states: “A common technique used to assist in fixturing the electrical sensor device 40 known within the automotive industry is to fill the internal cavity with a coating material such as a neutral silicone or the like for purposes of retaining placement position.” Ex. 1001, 13:56–60. Although the Specification also asserts that the sensor assemblies disclosed in the 421 patent “do not use or require the use of any such coating or filing agents or materials for any fixturing of the electrical sensor device 40,” id. at 13:61–64, limitation 1b merely requires that the “sensor device . . . is disposed within the internal cavity and attached therein to prevent movement of the device within the internal cavity,” id. at 30:25–27. Absent a persuasive argument to the contrary, we preliminarily conclude that Yamaguchi-727’s use of potting material to hold its module 6 in place within its housing 20 meets the requirements of limitation 1b. Both parties are encouraged to adduce intrinsic evidence relating to the meaning of limitation 1b at trial. For all the reasons set forth above, we find that Petitioner has established a reasonable likelihood of proving the Yamaguchi-727 renders claim 1 unpatentable as obvious. 2. Dependent Claims 2, 7–9, 11, 12, and 20–24 Petitioner identifies the portions of Yamaguchi-727 that teach the limitations introduced in dependent claims 2, 7–9, 11, 12, and 20–24, all of which ultimately depend from claim 1. Pet. 32–40. Patent Owner relies upon its argument that Petitioner’s showing for claim 1 is deficient as the reason why Petitioner’s challenge to dependent claims 2, 7–9, 11, 12, and 20–24 fails. We reject this argument for the reasons stated in Part II.C.1 above. Based on our review of Petitioner’s otherwise uncontested argument and evidence cited in support, we find that Petitioner also establishes a reasonable likelihood of proving that Yamaguchi-727 renders dependent claims 2, 7–9, 11, 12, and 20–24 unpatentable as obvious. D. Remaining Challenges” slip op. at 11

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

    “Petitioner complies with the requirement of identifying “[h]ow the claim language is to be construed” by setting forth proposed interpretations of various claim terms in the table above.7 Both cases cited by Patent Owner relate to an issue presented by a petitioner’s alleged inconsistent handling of whether a claim term is subject to interpretation as a means-plus-function element under 35 U.S.C. § 112(f). Orthopediatrics Corp. v. K2M, Inc., IPR2018-01546, Paper 10 at 11 (PTAB Feb. 14, 2019); 10x Genomics, Inc. v. President and Fellows of Harvard College, IPR2023- 7 Neither party has identified any claim language that might invoke interpretation as a means-plus-function limitation, and we discern no such claim language. Additionally, we do not imply that a petitioner must always propose express interpretations for specific claim language to comply with Rule 42.104(b)(3). Rather, we only note that Petitioner has, by any measure, complied by expressly proposing interpretations for identified claim language.” slip op. at 7

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

    “We disagree. Positioning module 6 to face a “predetermined direction” is a form of preventing movement that falls within the scope of limitation 1b. Moreover, Yamaguchi-727 uses a method for preventing movement of its module 6 in its housing 20, silicone potting material, that is expressly recognized by the Specification of the ’421 patent when it states: “A common technique used to assist in fixturing the electrical sensor device 40 known within the automotive industry is to fill the internal cavity with a coating material such as a neutral silicone or the like for purposes of retaining placement position.” Ex. 1001, 13:56–60. Although the Specification also asserts that the sensor assemblies disclosed in the 421 patent “do not use or require the use of any such coating or filing agents or materials for any fixturing of the electrical sensor device 40,” id. at 13:61–64, limitation 1b merely requires that the “sensor device . . . is disposed within the internal cavity and attached therein to prevent movement of the device within the internal cavity,” id. at 30:25–27. Absent a persuasive argument to the contrary, we preliminarily conclude that Yamaguchi-727’s use of potting material to hold its module 6 in place within its housing 20 meets the requirements of limitation 1b. Both parties are encouraged to adduce intrinsic evidence relating to the meaning of limitation 1b at trial. For all the reasons set forth above, we find that Petitioner has established a reasonable likelihood of proving the Yamaguchi-727 renders claim 1 unpatentable as obvious. 2. Dependent Claims 2, 7–9, 11, 12, and 20–24 Petitioner identifies the portions of Yamaguchi-727 that teach the limitations introduced in dependent claims 2, 7–9, 11, 12, and 20–24, all of which ultimately depend from claim 1. Pet. 32–40. Patent Owner relies upon its argument that Petitioner’s showing for claim 1 is deficient as the reason why Petitioner’s challenge to dependent claims 2, 7–9, 11, 12, and 20–24 fails. We reject this argument for the reasons stated in Part II.C.1 above. Based on our review of Petitioner’s otherwise uncontested argument and evidence cited in support, we find that Petitioner also establishes a reasonable likelihood of proving that Yamaguchi-727 renders dependent claims 2, 7–9, 11, 12, and 20–24 unpatentable as obvious. D. Remaining Challenges” slip op. at 11

  Claim construction§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 11,835,421
• Teladoc Health, Inc. v. Data Health Partners, Inc.Some claims unpatentable
  PTAB · Sep 12, 2025 · IPR2024-00617 · APJ Andreas Baltatzis · IPR · Final written decision

  Claims 1–5, 9–14, 16–18, and 20 are unpatentable as obvious; claims 6 and 7 were not shown unpatentable because the asserted grounds did not establish their missing limitations.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner argues that one of ordinary skill in the art relevant to the challenged claims, as of the earliest claimed priority date, “would have had at least a bachelor’s degree in a healthcare field as well as 1–2 years of experience with health information technology, including specific experience with computer-based systems for recording, tracking, and analyzing patient health information.” Pet. 6 (citing Ex. 1012 ¶ 36). Petitioner’s description of the level of ordinary skill in the art is supported by the testimony of Petitioner’s declarant, Dr. Bryan Bergeron. Ex. 1012 ¶ 36. Patent Owner does not oppose Petitioner’s definition of a person of ordinary skill in the art. See generally PO Resp.; Ex. 2005 ¶ 32. On the full record, we determine Petitioner’s proposed level of skill comports with the qualifications a person would have needed to understand and implement the teachings of the ’142 patent and the prior art of record. C. Claim Construction” slip op. at 7

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

    “We agree with Petitioner that the Specification supports construing “selection” as including inputs to a user interface, thereby “assigning” a client to a provider within the system. For example, the Specification describes a user interface including selection components. Ex. 1001, 10:45– 48 (“the user interface . . . may display . . . selection or display components”), 12:19–22 (authorized users may make selections by doubling tapping a touchscreen). The Specification further discloses that the “administrators may have complete access to the service providers and the clients to assign the clients to individual service providers through the user interface.” Id. at 11:13–18 (reference numerals removed, emphasis added). Taken together, we agree with Petitioner that assigning clients in response to selections of a user interface is consistent with the plain and ordinary meaning of the claims and the Specification. We decline to read Patent Owner’s additional limitations of “deliberate and active choice” into the claim, because these additional limitations lack support both in the claim language and the Specification. We do agree with Patent Owner’s argument that assigning and selection must be distinct elements, because they are separately listed and assigning happens in response to selection(s).” slip op. at 9

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

    “We agree with Patent Owner that the Specification defines “projected closure date” as the date at which a goal will end. However, we agree with Petitioner that this definition is not limited to final goals, and would include the end date of any goal, including intermediate goals. Accordingly, we interpret “projected closure date” as the date at which any goal will end. We apply that definition below.” slip op. at 12

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

    “Patent Owner responds that “Petitioner does not identify any selection made by Douglas’s administrator which may result in assignment of a provider.” PO Resp. 15 (citing Pet. 19–20; Ex. 1002, 6:33–7:13, Fig. 2). First, Patent Owner construes “selection” as “a deliberate and active choice by an administrator,” and argues that “Douglas discloses no such selection.” Id. at 15–16 (citing Ex. 1001, 11:13–18; Ex. 2005 ¶ 66). Instead, “Douglas’s administrator merely inputs pre-determined information from the prescription form” that the physician provided and thereby selected. Id. at 16 (citing Ex. 1002, 6:33–7:13, Fig. 2; Ex. 2005 ¶ 67). We find this argument not commensurate with the claim scope. As discussed above in claim construction, we decline to read Patent Owner’s additional limitations of “deliberate and active choice” into the selection limitation as lacking support both in the claim language and the Specification. Supra, Section III.C.1. Second, Patent Owner argues that Douglas does not teach assigning “in response to” an administrator’s selection. PO Resp. 16–17. Instead, Patent Owner argues that Douglas’s “information entered by the case advisor was provided by the physician.” Id. (citing Ex. 1002, 6:33–7:16). Again, we find this argument not commensurate with the claim scope, as the claim does not require a single assignment of client to provider. In other words, even if Douglas’s prescription information qualifies as a first assignment of client to provider, Douglas teaches the administrator using the same information to assign the client to a provider within the system, thereby meeting the required claim limitation.” slip op. at 16

  Patent outcomesUS 11,151,142 mixed
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,151,142
• Teladoc Health, Inc. v. Data Health Partners, Inc.Some claims unpatentable
  PTAB · Sep 12, 2025 · IPR2024-00616 · APJ Andreas Baltatzis · IPR · Final written decision

  Claims 1–9, 11–17, 19, and 20 are unpatentable as obvious; claim 10 was not shown unpatentable because the petition lacked evidence supporting the proposed missing-data alert modification.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner argues that one of ordinary skill in the art relevant to the challenged claims, as of the earliest claimed priority date, “would have had at least a bachelor’s degree in a healthcare field as well as 1–2 years of experience with health information technology, including specific” slip op. at 7

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

    “We agree with Patent Owner that the separately listed “goals, a plan of action, and thresholds,” should be considered distinct elements that cannot exist as the “same element” and therefore must be separately taught by the art. However, we agree with Petitioner that the claims and Specification describe the elements as interrelated whereby one may interact the other, even if they are separate elements. See Google, 92 F.4th at 1059 (“The proper construction of the term must allow for any of the five claimed inputs to potentially be used to calculate another claimed input.”).” slip op. at 10

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

    “modify Douglas with Wager to “ensure that the assigned physician had the capacity to effectively treat the patient,” given the number and variety of patients in Douglas’s system. Pet. 54–55 (citing Ex. 1002, 6:6–14, 6:36–7:4, Figs. 51, 57; Ex. 1012 ¶ 129). Petitioner asserts that Wager addresses this problem by presenting the staff manager “with a suite of provider assignment options and alternatives, to automatically organize and drive assignment ratios and other assignment parameters and options with compliance, capacity, best practice and other criteria taken into account.” Id. at 54 (citing Ex. 1003 ¶¶ 6–7; Ex. 1012 ¶ 128). Petitioner further argues that the combination “would have also helped ensure that the assigned physician had the capacity to effectively treat the patient” because Wager’s interface effectively manages capacity issues against fluctuating clinical demands, thereby increasing quality of care for the patient. Id. at 55 (citing Ex. 1003 ¶¶ 6, 8, 20; Ex. 1012 ¶ 129). Patent Owner makes six different arguments that one of ordinary skill would not have been motivated to combine Douglas with Wager. PO Resp. 36–46. As discussed below, Patent Owner’s arguments do not persuasively rebut Petitioner’s articulated reasons to combine the references, because Patent Owner’s arguments are inconsistent with KSR’s “expansive and flexible approach” to obviousness. See 550 U.S. at 415.” slip op. at 44

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

    “Finally, Patent Owner argues that “Douglas teaches against accomplishing its goals in an in-person setting like the one to which Wager is directed.” PO Resp. 43–45 (citing Ex. 1003 ¶¶ 4, 5, 11, 13; Ex. 2005 ¶ 108; Ex. 2006, 66:6–19). Patent Owner argues that Douglas’s system remotely monitors patients to avoid the costs and inconvenience of in-person programs. Id. (citing Ex. 1002, 1:29–35, 2:5–7; Ex. 2005 ¶ 109; Ex. 2006, 67:16–68:2). Patent Owner adds that Douglas’s teaching of office visits does not contradict the “remote only” argument, but instead, reinforces the patient’s desire to remain with their original physician, “instead of utilizing the proposed Douglas-Wager system to reassign the patient to a new physician.” Id. at 45. We are not persuaded by Patent Owner’s argument that Douglas teaches away from the combination with Wager. Douglas’s preference for remote medicine does not criticize or discourage office visits or the combination with Wager’s in-person setting. See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004) (“The prior art’s mere disclosure of more than one alternative does not constitute a teaching away from . . . alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed.”). Accordingly, there is no teaching away from the combination with Wager’s computerized system for assigning patients to physicians.” slip op. at 47

  Patent outcomesUS 11,144,554 mixed
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,144,554
• Samsung Electronics Co., Ltd. v. Netlist, Inc.Adverse judgment
  PTAB · Sep 8, 2025 · IPR2025-00002 · APJ Norman H Beamer · IPR · Adverse judgment

  The Board entered adverse judgment against Patent Owner on claims 1–20 after disclaimer and terminated the proceedings.

  RulingsAdverse judgment

  • Adverse judgmentAdverse judgmentGranted

    “DISCUSSION A party may request judgment against itself at any time during a proceeding. 37 C.F.R. § 42.73(b). Actions construed as a request for entry of adverse judgment include “[c]ancellation or disclaimer of a claim such that the party has no remaining claim in the trial.” Id. Patent Owner has disclaimed, under 37 C.F.R. § 1.321, claims 1–20 of the ’024 patent and claims 1–20 of the ’319 patent, and explicitly requests that the Board enter adverse judgment against it with respect to those claims, the only claims at issue in these trials. Paper 26, 1.” slip op. at 2

  None
  Patents in suitUS 11,880,319
• Samsung Electronics Co., Ltd. v. Netlist, Inc.Adverse judgment
  PTAB · Sep 8, 2025 · IPR2025-00001 · APJ Norman H Beamer · IPR · Adverse judgment

  Adverse judgment was entered against Patent Owner on claims 1–20 after statutory disclaimer; the proceedings were terminated.

  RulingsAdverse judgment

  • Adverse judgmentAdverse judgmentGranted

    “DISCUSSION A party may request judgment against itself at any time during a proceeding. 37 C.F.R. § 42.73(b). Actions construed as a request for entry of adverse judgment include “[c]ancellation or disclaimer of a claim such that the party has no remaining claim in the trial.” Id. Patent Owner has disclaimed, under 37 C.F.R. § 1.321, claims 1–20 of the ’024 patent and claims 1–20 of the ’319 patent, and explicitly requests that the Board enter adverse judgment against it with respect to those claims, the only claims at issue in these trials. Paper 26, 1.” slip op. at 2

  None
  Patents in suitUS 11,386,024
• Synaffix B.V. v. Hangzhou Dac Biotech Co., Ltd.Some claims unpatentable
  PTAB · Aug 26, 2025 · IPR2022-01531 · APJ Devon Zastrow Newman · IPR · Final written decision

  Claims 1–17, 20, 21, 24, 26, and 29–31 are unpatentable; claims 25 and 32–34 were not shown unpatentable, and the motion to exclude was dismissed as moot.

  RulingsFinal written decision

  • RemandOther

    “review of claims 1–17, 20, 21, 24–26, and 29–34 of the ’682 patent. Paper 2 (“Pet.”), 1, 3. Patent Owner, Hangzhou DAC Biotech Co., Ltd., filed a Preliminary Response (Paper 9, “Prelim. Resp.”). We initially determined that the information presented in the Petition did not establish a reasonable likelihood that Petitioner would prevail with respect to at least one of the challenged claims, and did not institute inter partes review. Paper 17. Petitioner requested Director review of our decision denying institution (Paper 18 (“Request”)). The Director delegated review of the decision to a Delegated Rehearing Panel (“DRP”). Paper 19. Patent Owner was granted the option to file a response to Petitioner’s Request (Paper 22 (“Request Resp.”)). The Delegated Review Panel vacated our decision and remanded the case to this panel with a revised claim construction for claim 1. Paper 23 (“DRP Dec.”). On August 30, 2024, we instituted an inter partes review after remand from the Director. Paper 25 (“Inst. Dec.”). Patent Owner subsequently filed a Patent Owner Response (Paper 31, “Resp.”), Petitioner filed a Reply (Paper 36, “Reply”), Patent Owner filed a Sur-reply (Paper 44, “Sur-reply”), and Petitioner filed a Sur-sur-reply (Paper 48, “Sur-sur-reply”).” slip op. at 2

  • PTAB / AIA Trials › Motions to amend / substitute claimsOther

    “I. Patent Owner’s Motion to Exclude Evidence Patent Owner moves to exclude Exhibits 1089 and 1090. Paper 50. As we did not rely on either of Exhibits 1089 or 1090 in deciding this matter, Patent Owner’s motion is dismissed as moot.” slip op. at 96

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

    “For these reasons, Patent Owner’s arguments and cited evidence also” slip op. at 31

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableNot shown unpatentableMixed

    “function as R2, and the ethyl group may function as R4, which can be a linear alkyl having 1–6 carbon atoms. We note that claim 3 permits R5 and R6 to be absent. For these reasons, the arguments presented in the Petition demonstrate that claim 3 would have been obvious over Singh’s Compound 3 when modified in view of Harris.” slip op. at 73

  Patent outcomesUS 10,131,682 mixed
  § 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,131,682

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.