• 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
• Under Armour, Inc. v. Athalonz, LLCAll claims unpatentable
  PTAB · Sep 11, 2025 · IPR2024-00636 · APJ Matthew S Meyers · IPR · Final written decision

  Claims 1–8 are unpatentable as obvious over Kim; the Board did not reach the four other instituted grounds.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Based on the full record, we determine that Petitioner’s proposed level of skill is reasonable and consistent with the ’786 patent and the asserted prior art. Thus, for these reasons, we adopt Petitioner’s level of skill in the art for purposes of this Decision.” slip op. at 7

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

    “Based on the full record, we maintain that it is unnecessary to explicitly construe “athletic positioning” because its meaning is already captured in the claim through the recitation of the relationship between the various slopes of the sole that provide “athletic positioning” of the foot. See Ex. 1001, 44:2–14. The recitations of a “first slope,” “second slope,” “third slope,” and “reference slope” translate into the relative heights proposed in adopt Patent Owner’s proposed construction because it incorporates the specification’s consistent descriptions of “athletic positioning” in terms of relative heights and slopes. For example, one embodiment of an “athletic positioning shape” is where “the heel platform may be 10 to 30 mm higher” than “the toe cup and/or the ball of foot cup.” [Ex. 1001], 13:38–45. Another embodiment discloses “an athletic positioning sole that includes an overall geometric shape” including “the heel of the sole [at] a particular height (e.g., h1, which may be 1’s to 10’s of mm) that slopes at an angle (e.g., Ø1) to the toe on the inside edge of the sole” which “may have a height of zero to a few millimeters.” Id., 17:54–62. PO Resp. 29. However, we find Patent Owner’s contention regarding particular heights and specific angles attempts to import limitations from the Specification into claims. Superguide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 875 (Fed. Cir. 2004) (“Though understanding the claim language may be aided by the explanations contained in the written description, it is important not to import into a claim limitations that are not a part of the claim.”). Based on the full record, we determine that express claim construction of “athletic positioning” is not necessary to resolve the present dispute. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those 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))).” slip op. at 9

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

    “8. Conclusion for Ground 1 We have considered all of the arguments and evidence adduced at trial. For the reasons explained, we find Petitioner has persuasively demonstrated that Kim teaches or suggests all limitations of claims 1–8. We also find that the value of Patent Owner’s objective evidence of non-obviousness is weak in comparison to the evidence regarding the prior art under the first three Graham factors. Accordingly, we find Petitioner has shown by a preponderance of the evidence that claims 1–8 of the ’786 patent would have been obvious over Kim.” slip op. at 39

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

    “Based on the full record, we determine that Patent Owner fails to show nexus between the claimed invention and the asserted objective indicia of nonobviousness. PO Resp. 70–78; PO Sur-reply 25–28. Other than asserting that “the requisite nexus exists here” (PO Resp. 71), and citing to the Declaration testimony of Mr. Markison (id. (citing Ex. 2008 ¶ 322)), the Patent Owner response does not provide an analysis of Patent Owner’s product with respect to the claims of the ’768 patent, and thus does not demonstrate nexus. To the extent Patent Owner references Mr. Markison’s testimony, Mr. Markison’s testimony consists solely of the statement that Patent Owner “sells and markets golf and baseball shoes that embody the claims of the ’786 patent” with reference to an exhibit from district court litigation. See Ex. 2008 ¶ 322 (citing Ex. 2014). We find Patent Owner’s reliance on Mr. Markison’s testimony to be insufficient to establish a rebuttable presumption of nexus. Thus, Patent Owner is not entitled to a rebuttable presumption of nexus, because Patent Owner has not shown that the asserted evidence is tied to a specific product that is the disclosed and claimed invention. Fox Factory, Inc. v. SRAM, LLC, 944 F.3d 1366, 1373 (Fed. Cir. 2019). Patent Owner also does not provide any evidence that the asserted” slip op. at 33

  Patent outcomesUS 10,674,786 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,674,786
• Under Armour, Inc. v. Athalonz, LLCAll claims unpatentable
  PTAB · Sep 10, 2025 · IPR2024-00638 · APJ Matthew S Meyers · IPR · Final written decision

  Claims 1–11 are unpatentable: claims 1–3, 6–8, and 11 as obvious over Kim, and claims 4, 5, 9, and 10 as obvious over Kim and De Obaldia.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “A person of ordinary skill in the art would have (1) at least a B.S. or equivalent degree related to industrial or product design and at least two years’ experience designing or developing athletic shoes; or (2) at least five years designing or developing athletic shoes. Pet. 15 (citing Ex. 1002 ¶ 31). Petitioner adds, however, that “the claims are obvious in view of any reasonable definition of a POSITA [(Person of Skill in the Art)].” Id. Patent Owner responds that “[f]or purposes of this proceeding, Patent Owner does not dispute Petitioner’s level of ordinary skill.” PO Resp. 23 (citing Pet. 15). Patent Owner adds that Mr. Markison’s “knowledge and experience, which includes 13 years of designing and developing athletic shoes that embody the patent at issue here, far exceeds the proposed level of ordinary skill in the art.” Id. at 24 (citing Ex. 2008 ¶¶ 43–44). Based on the full record, we determine that Petitioner’s proposed level of skill is reasonable and consistent with the ’760 patent and the asserted prior art. Thus, for these reasons, we adopt Petitioner’s level of skill in the art for purposes of this Decision.” slip op. at 7

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

    “In the Institution Decision, we declined to explicitly construe “athletic positioning” because we determined it was unnecessary in view of the claim language. Inst. Dec. 8. More particularly, we stated “independent claim 1 already appears to itself define the term ‘athletic positioning.’ In particular, the claim recites that the big toe area is at a lower position than the heel area and the small toe area.” Id. Based on the full record, we maintain that it is unnecessary to explicitly construe “athletic positioning” because its meaning is already captured in the claim through the recitation of the relationship between the various slopes of the sole that provide “athletic positioning” of the foot. See Ex. 1001, 43:17–27, 43:30–40. The recitations setting forth a relationship between a “big toe area,” a “heel area,” and a “small toe area” translate into the relative heights proposed in Patent Owner’s construction. Patent Owner contends that the Board should adopt Patent Owner’s proposed construction because it:” slip op. at 9

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

    “We have considered Petitioner’s arguments and evidence, and Patent Owner’s counterarguments and find, on the complete trial record, that Petitioner demonstrates, by a preponderance of the evidence, that Kim teaches or suggests “a foot platform that provides an athletic positioning of a big toe area at a lower position than a heel area,” as called for by claim 1. In this regard, we credit Mr. Delgatty’s Declaration testimony that one of ordinary skill in the art “would understand that, when worn, the toe area would be on the ground, and thus lower than the heel, and based on the sloped forefoot, the big toe would be lower than the small toe.” Pet. Reply 10 (citing Ex. 1022 ¶ 16). We also credit Mr. Delgatty’s opinion that one of ordinary skill in the art would have understood “that the shape and orientation of the sole (i.e., the platform on which an athlete stands) in relation to the ground is what determines if the foot is placed in an athletic position when in use.” Id. at 14 (citing Ex. 1022 ¶ 23). We find Mr. Delgatty’s opinion to be reasonable and supported by Kim’s disclosure. See, e.g., Ex. 1005 ¶¶ 37, 43, 44. Here, as Petitioner points out, “the ’760 patent distinguishes between the ‘sole’ and ‘cleats’ as separate components of the shoe” (Pet. Reply 12 (citing Ex. 1001, 1:62–64)), and claim 1 only “requires that the forefoot platform of the sole provide the big toe area at a lower position than the heel area and the small toe area” (id. (citing Ex. 1022 ¶ 20)). When asked during deposition, Mr. Markison confirmed that “cleats” or “sport-specific bottom 190” may be “different item[s] in the shoe than the athletic-positioning sole.” Ex. 1023, 85:18–22. specific bottom,” it is not limited to a spike or cleat pattern, but also recites that it may be a “sport specific tread pattern.” Ex. 1001, 44:13–19. Based on the full record, we agree with Petitioner that “[w]hether or not a shoe has cleats, an athlete’s foot will be positioned the same with respect to the surface of the ground when in use, and thus obtain the same positioning benefits the ’760 patent purports to provide.” Pet. Reply 14 (citing Ex. 1022 ¶ 22). Accordingly, upon review of the information in the Petition and” slip op. at 27

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

    “Based on the full record, we determine that Patent Owner fails to show nexus between the claimed invention and the asserted objective indicia of nonobviousness. PO Resp. 69–77; PO Sur-reply 26–29. Other than asserting that “the requisite nexus exists here” (PO Resp. 70), and citing to the Declaration testimony of Mr. Markison (id. (citing Ex. 2008 ¶ 285)), Patent Owner’s response does not provide an analysis of Patent Owner’s product with respect to the claims of the ’760 patent, and thus does not demonstrate nexus. To the extent Patent Owner references Mr. Markison’s testimony, Mr. Markison’s testimony consists solely of the statement that Patent Owner “sells and markets golf and baseball shoes that embody the claims of the ’760 patent” with reference to an exhibit from district court litigation. See Ex. 2008 ¶ 285 (citing Ex. 2014). We find Patent Owner’s reliance on Mr. Markison’s testimony to be insufficient to establish a rebuttable presumption of nexus. Thus, Patent Owner is not entitled to a rebuttable presumption of nexus, because Patent Owner has not shown that claimed invention. Fox Factory, Inc. v. SRAM, LLC, 944 F.3d 1366, 1373 (Fed. Cir. 2019). Patent Owner also does not provide any evidence that the asserted objective indicia of nonobviousness is the direct result of unique characteristics of the claimed invention. Fox Factory, 944 F.3d at 1373–75; PO Resp. 69–77; PO Sur-reply 26–29. At best, Patent Owner merely implies that they are the result of unique characteristics of the claimed shoe. For our analysis below, even if nexus were shown, we identify additional reasons why we would give little weight to the asserted objective indicia of nonobviousness.” slip op. at 30

  Patent outcomesUS 11,064,760 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,064,760
• Under Armour, Inc. v. Athalonz, LLCAll claims unpatentable
  PTAB · Sep 10, 2025 · IPR2024-00640 · APJ Hyun J Jung · IPR · Final written decision

  Claims 1–5, 7, 9–15, and 17 are unpatentable: claims 10, 11, 15, and 17 over Won, and claims 1–5, 7, 9, and 12–14 over Won and Talarico ’911.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner argues that a person of ordinary skill in the art “would have (1) at least a B.S. or equivalent degree related to industrial or product design and at least two years’ experience designing or developing athletic shoes; or (2) at least five years designing or developing athletic shoes.” Pet. 17–18 (citing Ex. 1002 ¶ 31). According to Petitioner, “the claims are obvious in view of any reasonable definition of a [person of ordinary skill in the art].” Id. at 21. For institution, we preliminarily adopted Petitioner’s proposal. Inst. Dec. 4. “For purposes of this proceeding, Patent Owner does not dispute Petitioner’s level of ordinary skill.” PO Resp. 13 (citing Pet. 17–18). Patent Owner contends that its declarant Mr. Markison “far exceeds the proposed level of ordinary skill in the art” and, because he is registered as a patent attorney and licensed as an attorney, “can offer good faith and objective opinions on the issues in this proceeding.” Id. at 13–14 (citing Ex. 2008 ¶¶ 11–13, 17–30, 42–44). Based on the full record, we maintain and affirm that one of ordinary skill in the art “would have (1) at least a B.S. or equivalent degree related to industrial or product design and at least two years’ experience designing or developing athletic shoes; or (2) at least five years designing or developing athletic shoes.” Pet. 20–21 (citing Ex. 1002 ¶ 30); Inst. Dec. 9; Ex. 1002 ¶ 30; Ex. 2008 ¶ 44.” slip op. at 9

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

    “Petitioner notes that, although claim 1 recites a heel platform made of a “first material” and a forefoot platform made of a “second material,” the first and second materials can be the same based on Patent Owner’s apparent interpretation in related litigation. Pet. 27 n.1 (citing Ex. 1012, 30–44). Petitioner applies Patent Owner’s apparent interpretation to the challenges of this proceeding “[w]ithout conceding alternative arguments.” Id. At institution, we were persuaded by Patent Owner’s arguments and adopted a construction that the “first” and “second” materials are “different in some manner.” Inst. Dec. 7–8. Patent Owner responds that we should maintain the same construction and disputes Petitioner’s evidence that the “first” and “second” materials can be the same material. PO Resp. 15–19 (citing Pet. 27 n.1; Inst. Dec. 8, 12–13; Ex. 1012, Ex. E, 38, 52; Ex. 2014, 15). Patent Owner also argues that Petitioner should not be allowed to present new arguments or evidence in reply. Id. at 19–21. Petitioner replies that interpreting “first” and “second” materials to be different materials contradicts the plain language of the claims, the Specification, and Patent Owner’s infringement contentions. Pet. Reply 1–5 (citing Pet. 27 n.1; Prelim. Resp. 16–17; PO Resp. 16–18; Ex. 1001, 10:9– 19, 17:52–54, 21:64–22:4, 27:47–51, Figs. 43, 49, claims 1, 6; Ex. 1023, 47:1–48:1, 215:6–217:12, 224:13–225:19; Ex. 1025, 319; Ex. 1026). Patent Owner replies that Petitioner presents new arguments and evidence in reply. PO Sur-reply 5–9 (citing Pet. 27 n.1; Inst. Dec. 13; PO Resp. 16–21; Pet. Reply 1–3, 14 n.1; Paper 19). Patent Owner also argues that, even if Petitioner’s asserted new arguments and evidence are considered, they fail to support an interpretation of “first” and “second” Resp. 16–17; Pet. Reply 1–3; Ex. 1001, 17:50–54, 27:50–54, Figs. 43, 93; Ex. 1023, 215:6–217:12; Ex. 2014, 19–22)” slip op. at 12

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

    “4. Other Terms Based on the full record, express interpretation of other terms is not necessary to resolve the parties’ dispute. Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those 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)).” slip op. at 13

  • ExcludeMotion to exclude, grantedMotion to exclude, deniedMixed

    “Patent Owner does not satisfy its “burden of proof to establish that it is entitled to the requested relief.” 37 C.F.R. § 42.20(c). Evidence of how the inventor viewed claim terms can be useful in considering claim interpretation, and, thus, we agree with Petitioner that the exhibit is relevant. For the reasons stated below, however, we do not need to rely on the exhibit. Accordingly, Patent Owner’s Motion to Exclude Exhibit 1024 is dismissed as moot.” slip op. at 6

  Patent outcomesUS 11,510,456 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,510,456
• Under Armour, Inc. v. Athalonz, LLCAll claims unpatentable
  PTAB · Sep 10, 2025 · IPR2024-00637 · APJ Carl M Defranco · IPR · Final written decision

  Claims 1–5 are unpatentable as obvious over Kim; the Board did not reach the Dufour–Kim and Rubin–Kim grounds.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Under Armour proposes that one of ordinary skill in the art would have had— (1) at least a B.S. or equivalent degree related to industrial or product design and at least two years’ experience designing or developing athletic shoes; or (2) at least five years designing or developing athletic shoes. Pet. 11 (citing Ex. 1002 ¶ 31). Athalonz responds that “[f]or purposes of this proceeding, Patent Owner does not dispute Petitioner’s level of ordinary skill.” PO Resp. 23 (citing Pet. 11). There being no dispute, we see no reason to depart from Under Armour’s proposed definition of the level of skill in the art, as it appears reasonable and consistent with the asserted prior art and the ’291 patent..” slip op. at 5

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

    “outside edge” of the shoe. Ex. 1001, 43:23–28. Athalonz construes those terms to mean “the edges of the portion of the shoe where the foot sits” and that such construction is consistent with how one skilled in the art “would understand those terms in light of the specification.” PO Resp. 25 (citing Ex. 2008 ¶¶ 85, 90–91). Athalonz explains that “[i]n light of the specification, the ‘inside’ and ‘outside edges’ in the claims do not refer to the edges of the exterior of the shoe.” Id. (citing Ex. 2008 ¶¶ 90–91). Under Armour does not dispute Athalonz’s proposed construction of “inside edge” and “outside edge” as recited in claim 1. See Pet. 10; Pet. Reply 1. And, from our review of the record, Athalonz’s proposed construction appears consistent with the plain language of the claims and the specification. Thus, we adopt it for purposes of this decision. slip op. at 5

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

    “unnecessary to explicitly construe “athletic positioning shape” because its meaning is already captured in the claim through the recitation of the relationship between the various heights and slopes of the sole that define the “athletic positioning shape.” See Ex. 1001, 43:21–35. Those recitations translate into the relative heights proposed in Athalonz’s construction. Nonetheless, Athalonz contends that we should adopt its proposed construction because it incorporates the specification’s consistent descriptions of “athletic positioning” in terms of relative heights and slopes. For example, one embodiment of an “athletic positioning shape” is where “the heel platform may be 10 to 30 mm higher” than “the toe cup and/or the ball of foot cup.” [Ex. 1001], 13:3–8. Another embodiment discloses “an athletic positioning sole that includes an overall geometric shape” including “the heel of the sole [at] a particular height (e.g., h1, which may be 1’s to 10’s of mm) that slopes at an angle (e.g., Ø1) to the toe on the inside edge of the sole” which “may have a height of zero to a few millimeters.” Id., 10:11–16. PO Resp. 27–28. We find, however, that Athalonz’s proposed construction regarding particular heights and angles is nothing more than an attempt to improperly import limitations from the specification into claims. Superguide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 875 (Fed. Cir. 2004) (“Though understanding the claim language may be aided by the explanations contained in the written description, it is important not to import into a claim limitations that are not a part of the claim.”). In sum, we determine that express claim construction of “athletic positioning shape” is not necessary to resolve the present dispute. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those 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)).” slip op. at 6

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “Pet. Reply 6–10. In support, we credit the declaration testimony of Under Armour’s expert that one of ordinary skill in the art “would understand that the shape and orientation of the sole (i.e., the platform on which an athlete stands) in relation to the ground is what determines if the foot is placed in an athletic position when in use” and that “[c]leats serve to provide traction, not athletic positioning.” Id. at 8 (citing Ex. 1022 ¶ 15). We also agree with Under Armour’s expert that one of ordinary skill in the art “would [] understand that because the cleats’ height does not contribute to the athletic positioning shape when in use on soft ground (the surface on which golf is played), it would not be included in the measurement of the claimed first, second, and third heights.” Id. at 8–9 (citing Ex. 1022 ¶ 16). We find the testimony of Under Armour’s expert to be credible and supported by the trial record. For instance, the ’291 patent specification itself distinguishes between the “sole” and “cleats” of the shoe as separate components. Ex. 1001, 1:59–61. Similarly, Kim describes the sole and cleats as distinct components of a shoe, illustrating the industry’s understanding of these terms. Ex. 1022 ¶ 14; see also Ex. 1005 ¶¶ 9, 14, 15, 30, claim 1 (describing that the spikes, in Kim, “protrude” or “extend” from the “outsole” and are located below the outsole’s “lower surface.”). We also note that Athalonz’s inclusion of the height of Kim’s cleats in measuring the claimed “heights” appears to be inconsistent with its own litigation position in the parallel district court action. See Pet. Reply 9–10. In particular, as Under Armour notes, “Athalonz did not include the height of the cleats in the measurement of the claimed heights” in accusing Under Armour’s shoes that have cleats of infringement. Id. (citing Ex. 1025, 51, 55–56, 61–62 (Athalonz’s infringement contentions regarding claim limitations [1.6] and [1.9])). To the extent Athalonz asserts that its “infringement contentions are extrinsic evidence that should be afforded little weight” (PO Sur-Reply 12), we disagree. While Athalonz’s infringement contentions may indeed be extrinsic evidence, we nevertheless find they provide an indication of Athalonz’s understanding and application of the claims. As such, we find that Athalonz’s infringement contentions, together with the plain language of the claims, the specification, and the credible testimony of Under Armour’s expert, fully supports Under Armour’s assertion that one of ordinary skill in the art in the relevant time frame “would understand that the claimed first, second, and third heights would be measured with respect to the bottom of the sole, not with respect to the bottom of the cleats.” Pet. Reply 14; see also Ex. 1022 ¶¶ 10–24 (Under Armour’s expert confirming same).” slip op. at 12

  Patent outcomesUS 11,013,291 unpatentable
  Claim construction§ 103 obviousnesscites Graham
  Patents in suitUS 11,013,291
• Under Armour, Inc. v. Athalonz, LLCAll claims unpatentable
  PTAB · Sep 10, 2025 · IPR2024-00639 · APJ Hyun J Jung · IPR · Final written decision

  Claims 1–5 and 8 are unpatentable under § 103 over Umezawa and Gallas, Won and Talarico ’911, and Won, Talarico ’911, and Gallas; remaining grounds were not reached.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Based on the full record, we maintain and affirm that one of ordinary skill in the art “would have (1) at least a B.S. or equivalent degree related to industrial or product design and at least two years’ experience designing or developing athletic shoes; or (2) at least five years designing or developing athletic shoes.” Pet. 20–21 (citing Ex. 1002 ¶ 30); Inst. Dec. 9; Ex. 1002 ¶ 30; Ex. 2008 ¶ 44. We find that Petitioner’s proposed level of ordinary skill in the art is consistent with the ’768 patent and the asserted prior art.” slip op. at 10

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther

    “After considering the full record, we see no reason to disturb the adopted construction that the “first” and “second” materials, as claimed, are different in some manner. The outcome of our analysis below would not, however, change under an interpretation of “first” and “second” materials being the same material.” slip op. at 14

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

    “obviousness] involves weighing of the fact findings to conclude whether the claimed combination would have been obvious to an ordinary artisan.” Arctic Cat Inc. v. Bombardier Recreational Prods. Inc., 876 F.3d 1350, 1361 (Fed. Cir. 2017) (quoting In re Cyclobenzaprine Hydrochloride Extended- Release Capsule Patent Litig., 676 F.3d 1063, 1068–69 (Fed. Cir. 2012)). Above, based on full record before us, we provide our factual findings regarding (1) the level of ordinary skill in the art, (2) the scope and content of the prior art, (3) any differences between the claimed subject matter and the prior art, and (4) objective evidence of nonobviousness. In particular, we find that (1) Petitioner’s proposed level of ordinary skill in the art is consistent with the prior art of record, (2) Umezawa and Gallas teach or suggest all the limitations of claims 1–5 and 8, (3) one of manner asserted with a reasonable expectation of success, (4) nexus has not been shown for the alleged objective indicia of nonobviousness, and, even if nexus were shown, Patent Owner’s evidence of long-felt need and copying is entitled to little weight. Weighing these underlying factual determinations, a preponderance of the evidence persuades us that claims 1– 5 and 8 of the ’768 patent are unpatentable over Umezawa and Gallas.” slip op. at 44

  • Obviousness (§103) › Objective indicia / secondary considerations › Long-felt need / failure of othersObjective indicia outweighedDecided for petitioner

    “Based on the full record, we agree with Petitioner that Patent Owner fails to show a recognized persistent need, fails to explain why the cited prior art did not meet the need, and fails to show that the claimed invention met the need. Pet. Reply 26. We also determine that prior art shoes would have met Patent Owner’s alleged long-felt “need for putting athletes into a better athletic position.” See, e.g., Ex. 1005, 2:38–41 (“An object of the present invention is to provide golf shoes helpful in smoothly swing without a golfer having to think about weight transfer by smoothly placing the center of body weight on the heel portion.”); Ex. 1006 ¶ 10 (“The object of the easily applied to the inside of a foot.”); Ex. 1008, 13:20–23 (“According to the present invention new footwear is provided accommodating the foot’s natural angulation by providing a sole of dual-density materials which compensates the human foot to its environment.”). Thus, even if nexus were shown, we would give no weight to Patent Owner’s evidence of long-felt need.” slip op. at 42

  Patent outcomesUS 11,375,768 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,375,768
• Charles River Laboratories, Inc. v. Seikagaku CorporationInstituted
  PTAB · Sep 9, 2025 · PGR2025-00023 · APJ Michael J Fitzpatrick · PGR · Institution

  Instituted PGR on claims 1–9 because the Board found it more likely than not that at least one challenged claim is unpatentable over the ’629 publication.

  RulingsInstitution decision

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

    “Institution of a post-grant review requires that “the information presented in the petition filed under section 321, if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable” or that “the petition raises a novel or unsettled legal question that is important to other patents or patent applications.” 35 U.S.C. § 324(a)–(b). Determining whether to institute has been delegated to the Board. See 37 C.F.R. § 42.4(a) (“The Board institutes the trial on behalf of the Director.”). Upon consideration of the Petition and the Preliminary Response, and for the reasons explained below, we determine that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable. Accordingly, we grant the Petition.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “III. LEVEL OF ORDINARY SKILL IN THE ART Petitioner contends a person of ordinary skill in the art (“POSITA”) would have a Ph.D. degree in biological, chemical or biochemical engineering, molecular biology, or biochemistry and at least two years of experience in the field of utilizing or assessing horseshoe crab zymogen proteins (lysate, purified native and/or recombinantly produced) for endotoxin detection and quantitation. More education could substitute for experience to a certain extent, and vice versa. Pet. 22 (citing Ex. 1003 ¶¶48–49). Patent Owner does not dispute Petitioner’s description of a POSITA in its Preliminary Response. Prelim. Resp. 10. 1 In addition to other changes to Title 35, the AIA introduced amendments to 35 U.S.C. § 102. Because Patent Owner concedes that the ’725 application “contains, or contained at any time, a claim to a claimed invention that has an effective filing date on or after March 16, 2013” (Ex. 1022), the AIA version of § 102 applies to the ’109 patent. AIA § 3(n)(1)(B); Ex. 1001, 1:11–14 (claiming priority to the ’725 application). 2 US 2019/0241629 A1, published August 8, 2019 (“the ’629 publication” (Ex. 1015)). At this stage, we find Petitioner’s description of the level of ordinary skill in the art sufficiently supported by the record and apply it for purposes of this decision.” slip op. at 9

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

    “Neither party proposes an express construction of any claim term. See Pet. 22–23; Prelim. Resp. 10. We determine that no express claim construction is necessary based on the present record.” slip op. at 10

  • Disclosure Requirements (§112) › Written description (Ariad)Not shown unpatentable

    “To show that the claims of the ’109 patent are unpatentable for lack of written description, Petitioner would have needed to show that the specification as filed (i.e., the ’420 application) fails to reasonably convey to those skilled in the art that Patent Owner had possession of the claimed subject matter as of the July 3, 2023, filing date. Petitioner did not. Pet. 23– 24. Nor does Petitioner’s declarant offer testimony that could support such a showing. See Ex. 1003 ¶50 (“I have been asked to provide my opinions as to the state of the art in this field for purposes of determining what the inventors disclosed as their invention as of December 10, 2013.”), ¶51 (“Whenever I offer an opinion in this declaration about the knowledge of a POSA, the manner in which a POSA would have understood the claims of the ’109 patent or its description, the manner in which a POSA would have understood the prior art, or what a POSA would have been led to do based on the prior art, I am referencing the December 10, 2013 timeframe.”). Although the ’420 application is essentially identical to the ’767 application, the person of ordinary skill in 2013 is not the same as in 2023. See Ariad, 598 F.3d at 1351 (“[T]he [written description] test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.” (emphasis added)). Thus, the information presented in the Petition, which is limited to the perspective of a 2013 POSITA, does not demonstrate that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable for lack of written description.” slip op. at 12

  Claim construction§ 102 anticipation§ 112 disclosure
  Patents in suitUS 11,959,109

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.