• 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
• 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
• Bowmar Archery LLC v. Matthew FuttereNo claims unpatentable
  PTAB · Jun 30, 2025 · IPR2024-00401 · APJ Sean P O’Hanlon · IPR · Final written decision

  Claims 1–4, 7, 9, 11, 12, 15, and 17 were not shown unpatentable under any asserted anticipation or obviousness ground.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “The parties do not identify, and we do not discern, any material difference between the parties’ proposed definitions. For purposes of this decision and based on the record before us, we adopt Petitioner’s proposed definition of the level of ordinary skill. Also, we note that we would reach the same conclusions under either proposed standard.” slip op. at 9

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

    “1. Ferrule Petitioner argues that the ’177 patent “defines ‘ferrule’ as a ‘generally cylindrical body,’” which interpretation Petitioner asserts “is consistent with the ordinary meaning to [an ordinarily skilled artisan].” Pet. 19 (citing Ex. 1001, 2:53–55; Ex. 1019 ¶ 61). Patent Owner does not address Petitioner’s proposed interpretation of this claim term. See generally PO Resp. We adopt Petitioner’s uncontested interpretation of “ferrule.” 2. Blade Member Patent Owner argues that an ordinarily skilled artisan “would” slip op. at 10

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

    “As discussed in section II.C.2 above, we interpret a “blade member” to have a cutting surface. Petitioner does not support adequately its assertion that Lint’s barbs 19 have a cutting surface. Petitioner acknowledges that Lint discloses “barb 19,” but Petitioner merely labels the barbs as blade members in annotated versions of Lint Figure 2. Pet. 21–22, 24. Petitioner’s witness, Dr. Kuhn, provides substantially identical testimony, also failing to explain how Lint’s barbs have a cutting surface or perform a cutting function. See Ex. 1019 ¶¶ 68, 70. Such conclusory assertions fail to satisfy Petitioner’s burden of persuasion. To the contrary of Petitioner’s assertions, Lint discloses that its barbs do not perform a cutting function. Lint discloses that its barbs retract to the closed position upon impact with an animal. Ex. 1002, 2:62–67. Only when the arrowhead has “completely penetrated the flesh of an animal” does the spring urge the barbs into the extended position “to retain the arrowhead within the animal.” Id. at 2:67–70.6 Lint discloses that its barbs provide 6 During the hearing, Petitioner’s counsel argued that Lint’s disclosure of its barbs deploying “[a]fter the arrowhead 10 has completely penetrated the flesh of an animal” means the spring urges the barbs forward after the resistance to the removal of the arrow from an animal (id. at 1:53–57, 2:67–70), but Lint does not disclose its barbs as performing any cutting function. Thus, Lint’s barbs are not blade members with a cutting surface as we have interpreted the term above. Petitioner has failed to explain adequately how Lint discloses first and second blade members as recited in independent claims 1 and 11.” slip op. at 21

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

    “A claimed modification to the prior art may be an obvious design choice if the claimed structure performs the same function as in the prior art and it presents no novel or unexpected result over the prior art. See In re Kuhle, 526 F.2d 553, 555 (CCPA 1975) (finding that the use of the claimed feature “would be an obvious matter of design choice” when it “solves no stated problem” and “presents no novel or unexpected result” over the disclosed alternatives); Ex parte Maeda, Appeal No. 2010-009814, at 6–7 (PTAB Oct. 23, 2012) (informative) (“‘design choice’ may be appropriate where the applicant fails to set forth any reasons why the differences between the claimed invention and the prior art would result in a different function or give unexpected results” (citing In re Chu, 66 F.3d 292, 298–99 (Fed. Cir. 1995)). The ’177 patent explains that the purpose of the recited blade members is to maximize the cutting surface of the arrowhead through an animal’s soft flesh to increase the likelihood of a successful kill and minimize undue suffering of the animal. Ex. 1001, 1:26–30, 4:8–10, 4:21–24. The purpose of Lint’s barbs, on the other hand, is to resist removal of the arrow from an animal. Ex. 1002, 2:67–70. Indeed, Lint discloses that only when the arrowhead has “completely penetrated the flesh of an animal” does the spring urge the barbs into the extended position. Id. Thus, contrary to the conclusory assertions of Petitioner and Petitioner’s witness, Dr. Kuhn (see Pet. 49–51; Ex. 1019 ¶ 119), the recited blade members and Lint’s barbs perform vastly different functions. Neither Petitioner nor Dr. Kuhn explains adequately how the proposed modification to Lint’s barbs would be a mere matter of design choice. For at least the foregoing reasons, Petitioner’s first alternative” slip op. at 28

  Patent outcomesUS 8,043,177 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,043,177
• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  PTAB · Jun 9, 2025 · IPR2024-00240 · APJ Deborah Katz · IPR · Final written decision

  Claims 1–42 are unpatentable: claims 1–42 are anticipated by the MSR, and the Board also finds the challenged claims obvious over the MSR and cited combinations.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

    “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, 25:40–50, 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. Neither party directs us to evidence of the level of skill in the art beyond what we considered for institution of trial. In the Decision to institute trial, we determined that the level of skill in the art relevant to the claims of the ’393 patent is not limited to knowledge of and experience with conducting research relating to oncology or developing and conducting clinical trials. (See Dec. 8–9.) We determined that the level of skill also includes knowledge of and experience with treating colorectal 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. (See id.) Because the parties do not present additional evidence or argument, we maintain that determination.” slip op. at 9

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “what one of ordinary skill in the art would have known and understood at the relevant time. Specifically, Petitioner relies on the testimony of Alfred L. Neugut, M.D., Ph.D., M.P.H.3 (Ex. 1003) and Paul E. Oberstein, M.D. (Ex. 1150). Patent Owner relies on the testimony of Nils Lonberg, Ph.D. (Ex. 2001) and Richard Goldberg, M.D. (Ex. 2090).” slip op. at 8

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

    “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. We further agree that this relationship is different than the use of the term “after” in claims 7, 20, and 27, wherein patients must be treated with a different cancer therapy, and wherein the cancer must have later progressed for the treatment to be within the scope of these claims. (Ex. 1001, 25:66–7, 26:44–46, 26:63–64.) 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 12

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

    “Microsatellite Unstable (MSI) Tumors.” (Ex. 1005, 2.) The parties’ witnesses agree that MK-3475 is pembrolizumab, the compound recited in claim 1. (See Neugut Decl., Ex. 1003 ¶ 37; see Lonberg Decl., Ex. 2001, ¶ 65.) Patent Owner does not dispute Petitioner’s assertion that the MSR was published on a government web site on June 10, 2013, more than two years before the priority date of the ’393 patent on July 10, 2015. (See Pet. 7 (citing Ex. 1005, 3, Ex. 1003 ¶ 35).)” slip op. at 17

  Patent outcomesUS 11,591,393 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,591,393
• Intelligent Wellhead Systems, Inc. v. Downing Wellhead Equipment, LLCNo claims unpatentable
  PTAB · Jun 9, 2025 · IPR2024-00300 · APJ Frederick C Laney · IPR · Final written decision

  Claims 1–38 were not shown unpatentable because Petitioner failed to establish Krupa as prior art and failed to show the claimed fluid-triggered valve sequence in Carr or Tolman.

  RulingsFinal written decision

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

    “Although we agree with Petitioner that the plain meaning of limitation 1.2 does not require the recited determination to occur at the first well, it does require the determination to be about the condition(s) of the fluid communicated to the first well by the manifold, regardless of where or how the information is gathered to make that determination. Limitation 1.2 recites plainly that the “determining” step is specifically about whether “the fluid communicated via the manifold has satisfied one or more conditions.” Ex. 1001, 22:38–39 (emphasis added). Considering the antecedents for “the fluid” and “the manifold”––i.e., “communicating fluid to a first well via a manifold” (id. at 22:35, limitation 1.1)––limitation 1.2 expressly identifies the fluid which “the manifold” has “communicated” to the first well to be exactly the fluid used for “determining” whether “one or more conditions” are “satisfied” to trigger the recited responses. Id. This is because “the fluid” refers to a fluid passing to a first well by way of a manifold and the past tense of “communicated via the manifold” indicates, more specifically, that it is the fluid passed by the manifold which must satisfy a condition(s). The Specification of ’770 patent illustrates this by checking the “frac rate” of the fluid discharged by a manifold to a first well to make the determination about whether to permit a regular swap or a continuous pumping swap (“CP swap”). Ex. 1001, 13:30–54, Fig. 12. Therefore, contrary to Petitioner’s representation that limitation 1.2 does not “requir[e] the fluid used for ‘determining’ to have been communicated to the first well” (Pet. Reply 3), the plain meaning of limitation 1.2 does require the fluid used” slip op. at 12

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

    “anticipated by, or would have been obvious over, Krupa necessarily requires Krupa to be first qualified as prior art. See Tech. Licensing Corp. v. Videotek, Inc., 545 F.3d 1316, 1327 (Fed. Cir. 2008) (party’s burden to prove anticipation of a patent includes initial burden of going forward with evidence that there is anticipating prior art). Under 35 U.S.C. § 102(a)(2)— the subsection under which Petitioner contends Krupa qualifies as prior art—when the reference patent document’s actual filing date is before the challenged patent’s filing date, a petitioner need only refer to the filing dates appearing on the challenged patent and reference patent document to make prima facie showing that the reference is prior art. 35 U.S.C. § 102(d)(1) (“For purposes of determining whether a patent or application for patent is prior art to a claimed invention under subsection (a)(2), such patent or application shall be considered to have been effectively filed, with respect to any subject matter described in the patent or application—(1) if paragraph (2) does not apply, as of the actual filing date of the patent or the application for patent.”).” slip op. at 16

  • Strike new argumentNew argument disregardedDecided for patent owner

    “We determine that the Petition did not adequately present Petitioner’s contention that Tolman discloses or suggests a “master valve” that a skilled artisan would understand to be the claimed “first valve,” which is first introduced in the Reply. The issue is whether Petitioner’s identification of Tolman’s “tree valve” for the claimed first valve was particular enough to allow Petitioner to rely specifically on the “master valve” in the well tree to show Tolman discloses the first valve. We find that it is not. It is undisputed that a well tree include several different valves: (1) valves for communicating fluid to a well (e.g., for treatment or stimulation); (2) valves for communicating fluid from a well (e.g., for flowback); and (3) valves for communicating fluid both to and from a well (e.g., master valve). See Reply 19–20; Ex. 1002 ¶¶ 542–545; Ex. 1044 ¶¶ 33–34, 38–42; Tr. 33:12–18, 34:3–12, 36:8–37:18, 39:4–17; Ex. 2013, 85:4–86:19, 87:1–12, 89:2–11. And the opening/closing of these different valves are controlled independently of the other valves based on different parameters. Id. identifying a tree valve, generally, does not provide the particularity necessary to provide notice that the master valve is the particular valve being relied upon. Further compounding this problem is the fact that the Petition repeatedly refers to a plurality of valves, rather than a singular “master valve.” The variability of possible valves suggested by simply referring to a tree valve fails to provide a level of particularity that clearly identifies which specific structure is being relied upon to perform which part of the recited procedure. Ultimately, we agree with Patent Owner that because the Petition does not specifically identify the master valve in the Petition, which the Petitioner’s Reply suggest was the intention all along, Patent Owner was put at a disadvantage because its ability to fully develop a response was impeded. Therefore, Petitioner’s reliance particularly on the “master valve” of the well tree, and the newly introduced evidence associated therewith, was improper and may not be considered. Nevertheless, as discussed below, even if Petitioner were allowed to rely on the master valve, we still find the Tolman Grounds to be deficient.” slip op. at 56

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

    “However, Carr does not disclose or suggest: relying on the condition(s) of the fluid communicated by first isolated manifold path 122 to first well 140 to be the determinative factor for causing first and second valves 470 and 472 to perform a sequenced response that includes–– (1) opening second valve 472, (2) communicating fluid to second well 142 through second valve 472, and (3) after opening second valve 472, closing first valve 150 from communicating fluid to first well 140. At the time of the invention, when a first well is being operated individually using high pressure pumping, we find that skilled artisans would have considered concurrent operation of the second well’s valves to be hazardous and activities that can not occur. See Ex. 1031, 4 (“specifically identified activities that were restricted from occurring at the same time (i.e., CAN NOT OCCUR activities). As an example, if the operations on a well involved high pressure pumping . . . then manipulating manifold well valves and wellhead trees valves on another well were not allowed to be performed concurrently”); Ex. 2012 ¶ 148. would have had a reasonable expectation of being able to successfully avoid the unacceptable hazards known to be associated with opening second valve 472 and communicating fluid to second well 142, while individually operating on first well 140 using high pressure pumping.10 Furthermore, Petitioner provides no persuasive evidence that a skilled artisan would have known that those unacceptable hazards could be avoided (or acceptably minimized) by using a condition(s) of the fluid communicated by first isolated manifold path 122 to first well 140 as a trigger for opening second valve 472 and communicating fluid to second well 142, while first well 140 is being individually operated.” slip op. at 34

  Patent outcomesUS 11,560,770 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,560,770
• Provisur Technologies, Inc. v. Weber Food Technology GmbHAll claims unpatentable
  PTAB · May 28, 2025 · IPR2024-00235 · APJ Carl M Defranco · IPR · Final written decision

  Claims 1–6, 8, 10, and 14–16 are unpatentable as anticipated by Young and obvious over Young and Norrie; the Johnson and Belk ground was not reached.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Provisur proposes that one of ordinary skill in the art would have had: (1) a bachelor’s degree (or equivalent) in mechanical engineering (or a similar field) and at least two years of experience working as an engineer (or similar role) on food processing and/or packaging systems (or in a similar field); or (2) at least seven years of experience working as an engineer (or similar role) on food processing and/or packaging systems (or in a similar field). Pet. 12. Weber does not contest Provisur’s framing of the level of ordinary skill in the art. See generally PO Resp. There being no dispute, we adopt Provisur’s definition of the level of skill in the art.” slip op. at 5

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

    “Provisur construes the claim terms “according to their plain and ordinary meanings as understood by a [person of ordinary skill in the art] in view of the specification and prosecution history” and posits that “[n]o terms require an explicit construction to resolve the unpatentability controversy between the parties here.” Pet. 13. Weber appears to agree, stating in the related district court action that “most of [its] patent claims are plain and ordinary . . . [t]hey’re not difficult or complex claims or claim terms.” Ex. 3 US 5,514,032, issued May 7, 1996 (Ex. 1004, “Young”). 4 US 4,979,269, issued Dec. 25, 1990 (Ex. 1005, “Norrie”). 5 US 6,929,540 B2, issued Aug. 16, 2005 (Ex. 1006, “Johnson”). 6 US 6,198,834 B1, issued Mar. 6, 2001 (Ex. 1007, “Belk”). 1028, 5. This being the case, we do not find the need to expressly construe any claim terms. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (confirming that the Board need not construe claim terms where their construction is not material to the dispute).” slip op. at 5

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

    “without first determining how much fat existed to begin with, i.e., prior to the side of meat being trimmed. But, as Provisur correctly notes, Weber ignores what one skilled in the art reasonably would have understood from reading Young’s disclosure as a whole. See Pet. 30–36 (citing Ex. 1003 ¶¶ 104–106, 109–112); Pet. Reply 2–12. When that is done, one skilled in the art would have understood that a necessary premise of Young’s determination of the thickness of fat to remain on the loin is knowing the thickness of the fat to begin with, which Young’s imaging system 190 and imaging processing routine 240 determine by first analyzing a series of “fat/lean separation lines” and “edge lines” in the side of meat being trimmed. Pet. 30–32 (citing Ex. 1004, 17:34–62, 18:33–56, 22:53–24:38, Figs. 2, 13); Pet. Reply 3–7 (citing portions of same evidence). More specifically, as described in Young (and articulated by Provisur), the side of meat is placed fat side down on a product support, i.e., platen 20. See Ex. 1004, 7:16–21, Figs. 1, 2. Using several cameras—top plan camera 196, end view camera 197, and fat line camera 198—Young’s imaging system 190 acquires multiple images of the side of meat from various angles and under various lighting conditions to “provide image data regarding each side of [meat].” See id. at 17:34–18:56. That image data is then used by Young’s image processing routine 240 to generate a series of demarcation lines on the side of meat, including: (1) fat/lean separation lines (representing the interface between the loin meat and the fat layer along top, side, and end views of the meat product; and (2) edge lines (representing lines along the outer surface of the meat product). See id. at 22:53–23:67, Figs. 10, 13 (Blocks 242, 246, 250, 254). In addition, “a plurality of points (preferably 20) are generated for each of the fat/lean separation and edge lines using known pattern matching routines.” Id. at 23:28–30, Fig. 13 (Blocks 244, 248, 252, 256); see also id. at 23:61–63 (essentially same). The fat/lean separation and edge lines (and points therein) generated by Young’s image processing routine 240 are then used to calculate certain dimensions and characteristics of the side of meat, such as height, length, and width. Id. at 24:10–22, Fig. 13 (Block 258). As Provisur’s expert credibly testifies, one skilled in the art would have understood that the dimension from the fat/lean separation line to the edge line along the outer surface represents the thickness of fat cover on the side of meat, i.e., before the fat is trimmed. See Ex. 1003 ¶ 106. Insofar as how that dimension is used, Young states that controller 172 uses “dynamic (real time) image data” of the fat/lean separation and edge lines “to dynamically modify the cutting profile of the loin knife assembly 100 so that the assembly follows a fixed distance from the separation line to provide the optimum fat cover for the loin.” Ex. 1004, 18:32–45; see also id. at 17:48–52 (describing “real time processor” for “image processing routines”). Notably, according to Young, the “fixed distance” represents the “desired” thickness of fat that remains on the loin, after trimming, and “sufficiently keeps the loin from drying out, but doesn’t make the loin look too fat,” although “[o]ther fat thicknesses may be desired in the alternative.” Id. at 20:60–66; see also id. at 10:39–42 (“Through control of the knife blade along several axes, assembly 100 preferably produces an optimum separation between loin and belly, with a desired fat covering left on the loin.” (emphases added)). Because the desired thickness of fat cover is what remains on the loin” slip op. at 9

  • Strike new argumentNew argument consideredDecided for patent owner

    “argument that Weber considers vital to its dispute of Provisur’s showing for the claimed fat thickness determination. During oral hearing, Weber repeatedly argued that Provisur changed theories midstream, i.e., between the time of the petition and the hearing. See Hrg. Tr. 22:18–24:47; see also id. at 31:14–22, 33:8–18, 34:16–20, 49:17–50:15, 54:16–56:25 (repeating same argument). More specifically, according to Weber, Provisur originally relied only on image data from Young’s “top view” camera as processed in “block 246” of Young’s image processing routine 240 when showing how Young meets the claimed fat thickness determination, whereas now Provisur relies on image data from Young’s “end view” cameras as processed in “Block 254.” Compare PO Sur-Reply 3–6 (focusing on Young’s “top view camera” in “block 246”), with Hrg. Tr. 27:4–16 (“[Block] 246, which is what they relied on, is processing images from the top-view camera in Young’s system. It is generating lines from the top-view camera in Young’s system. What they are newly trying to rely on today, for the first time, is Block 254 that is discussed toward the bottom of column 23 in Young, and that analyzes different images from a different camera. It is the end camera. It generates different lines. It demonstrates an end fat/lean line and an end edge line. Prior to today’s hearing, neither Petitioner, nor its expert, had ever discussed Block 254. You will not find a single reference to 254 in their papers, nor have they discussed the end edge line. It is completely new today. It finds absolutely no support in the record.” (emphases added)). We disagree with Weber’s contention. As shown and described in the petition, Provisur relies on more than simply Young’s “top view” camera and “block 246.” See Pet. 29–31. Rather, in its petition, Provisur annotates Young’s Figure 2 to show that image data from all three cameras of “imaging system 190”—“top plan camera 196, end view camera 197, [and] fat line camera 198”—play a role in the determination of fat thickness.8 Id. at 30. Moreover, Provisur cites the entire process depicted in “Figure 13” and described in columns “22:53–24:38” of Young as critical to the determination. Id. at 31. Those cited portions of Young involve not only the analysis of fat/lean and edge lines from “top view” images (block 246), but also the analysis of fat/lean and edge lines from “end view” images (blocks 250 and 254). See Ex. 1004, 23:12–24:13. In other words, Provisur’s showing for the claimed fat thickness determination is based on Young’s collective analysis of all those images. Indeed, Provisur’s expert confirms as much when confronted by Weber on cross-examination— Q. How does [Young] use the other cameras to identify that fat/lean separation line? A. Again, this is a -- this is a three-dimensional product that’s not regular, and all the views basically are needed to be able to describe that complex three-dimensional shape, so that the knife will be able to cut at that -- at that line, offset by whatever desired thickness there is, on that three-dimensional shape. Ex. 2006, 25:15–27:19 (emphasis added). 8 Indeed, contrary to Weber’s assertion, Provisur highlights “fat lean separation camera 198,” not top view camera 196, as most critical to the determination of fat thickness. Pet. 31. In the end, we reject the notion that Provisur changed theories” slip op. at 12

  Patent outcomesUS 8,529,321 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness
  Patents in suitUS 8,529,321
• Lululemon USA Inc. v. Nike, Inc.Some claims unpatentable
  PTAB · May 21, 2025 · IPR2024-00159 · APJ Carl M Defranco · IPR · Final written decision

  Claims 8, 9, 14, 15, and 19 are unpatentable over Minami; claims 1–3, 7, 16–18, and 20 were not shown unpatentable over Good or Munsing.

  RulingsFinal written decision

  • Skill levelSkill level board ownOther

    “lululemon contends, and Nike does not dispute, that a person skilled in the art in the relevant time frame would have had “at least a bachelor’s degree in mechanical engineering, textile engineering, or similar technical degree and at least 3 years of experience working with knitted textiles for use in fabric-based articles, including apparel such as footwear” and such person’s “additional experience compensates for any differences in that person’s education as stated above.” Pet. 13–14 (citing Ex.1003 ¶¶ 33–35); see also PO Resp. 14 (“For purposes of this proceeding, Nike applies lululemon’s proposed level of skill in the art.”). We find that lululemon’s proposed definition is consistent with the problems and solutions described in the ’046 patent and the prior art of record. Thus, we adopt the parties’ agreed-upon definition of the level of skill in the art.” slip op. at 6

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

    “We are not persuaded by lululemon’s attempt to equate the term “channel” in that passage with an open-periphery configuration. Nowhere does that passage indicate that the “channel” has an open-periphery. Instead, lululemon merely presumes, without support, that channels are open-periphery structures. More accurately, the terms “tunnel” and “channel” in the passage cited by lululemon are used synonymously. That is made clear by the overall context of the ’046 patent at issue, which is directed to how tubular rib structures 126 are formed by “first” and “second” curved portions 416 and 418 that are “knitted together” to define “hollow tube 112.” See Ex. 1001, 10:16–11:14, Figs. 4, 5 (emphasis added). In particular, the sentence cited by lululemon describes hollow tube 112 as being “disposed between” first and second curved portions 416 and 418, which Figures 4 and 5 of the ’046 patent clearly depict in a closed-periphery configuration. See id. at 10:66–11:3, Figs. 4, 5. Moreover, the very next sentence expressly describes that hollow tube 112 has “a generally cylindrical or elliptical shape” wherein “[t]he diameter of one hollow tube and the diameter of other hollow tubes may differ in some embodiments.” Id. at 11:3–14 (emphases added). We are not aware of any open-periphery channels being described as having a cylindrical or elliptical shape, nor are we aware of such a channel being described as having a diameter. Thus, lululemon’s proposed claim construction ignores the context surrounding the ’046 patent’s description of the tubular rib structures when it describes them as having the configuration of a tunnel or channel.” slip op. at 10

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

    “We agree with Nike, given our construction of the claimed “tubular structures.” As shown in annotated Figures 1, 3, and 4 of Good (reproduced below), Good discloses a sock 12 having rib portions 22 (red) and webbed areas 24 (green). See PO Resp. 19. lululemon contends that Good’s rib portions 22 meet the claimed “tubular structures” because each rib portion 22 “roll[s] substantially together in the relaxed condition” and “has the shape of a tube, namely an elongate hollow structure.” Pet. 29–30. In support, lululemon points to Good’s Figure 3 (reproduced below center) as allegedly showing the tubular shape of Good’s rib portions 22. Id. at 30. Annotated Figure 3 is a vertical cross-section of rib portions 22 (red) shown in Good’s Figure 1. But, as Nike correctly notes, Good’s rib portions 22 are “C-shaped knitted portions,” which when stretched, go from an essentially C-shaped configuration (Figure 3) to a relatively flat, linear configuration (Figure 4). PO Resp. 19–20 (citing Ex. 2006 ¶¶ 48–49). Nowhere does Good disclose that the ends of C-shaped rib portions 22 ever meet and remain in a closed periphery configuration to form a hollow tube per our construction of “tubular structures” (as discussed above in Section II.B). In at least this way, Good’s C-shaped rib portions 22 differ from the claimed “tubular structures.”7 Thus, we find that Good does not disclose or otherwise suggest the claimed “tubular structures,” as properly construed, meaning that lululemon fails to demonstrate, by a preponderance of the evidence, that Good either anticipates claims 1–3, 7, 16–18, and 20, or, alternatively, renders obvious claim 3.” slip op. at 16

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “In our Institution Decision, we said that Munsing lacks the claimed “tubular structures” because “nowhere does Munsing indicate that the rows of stitches or loops form a rib that is tubular-like, let alone one with a closed periphery.” Inst. Dec. 10–12. During the trial phase, lululemon’s expert likewise agreed, conceding (on cross-examination) that Munsing only discloses non-tubular structures. See Ex. 2007, 40:9–41:11 (“Q [by Patent Owner’s counsel]: So you agree that . . . Munsing only discloses a nontubular rib? A [by lululemon’s expert]: That’s what I said.”). Nowhere does lululemon rebut that admission by its own expert, despite Nike noting it explicitly as a reason for rejecting Ground 2. Compare PO Resp. 25–26 (noting the admission of lululemon’s expert), with Pet. Reply 1–26 (addressing only Grounds 1 and 3, while omitting any mention of Ground 2, which is based on Munsing). Nor does lululemon ever dispute the preliminary findings in our Institution Decision as to why Munsing is not an anticipatory reference. Compare Inst. Dec. 10–12, with Pet. Reply 1–22. Thus, lululemon fails to demonstrate, by a preponderance of the evidence, that Munsing anticipates challenged claims 1–3, 7, 17, 18, and 20.” slip op. at 18

  Patent outcomesUS 9,375,046 mixed
  Claim construction§ 102 anticipation§ 103 obviousness
  Patents in suitUS 9,375,046
• Curio Bioscience, Inc. v. Prognosys Biosciences Inc. And 10x Genomics, Inc.Institution denied
  PTAB · May 21, 2025 · IPR2025-00193 · APJ Sheridan K Snedden · IPR · Institution

  The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1, 3, 6, 10, 11, 16, 18, 21, 24–26, or 30 were unpatentable on any asserted ground.

  RulingsInstitution decision

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

    “To institute an inter partes review, we must determine that the information presented in the Petition shows “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). After considering the evidence and arguments presented in the Petition, we determine that Petitioner has not demonstrated a reasonable likelihood of success in proving that at least 1 claim of the ’030 patent is unpatentable.” slip op. at 2

  • BurdenNot shown unpatentable

    “What is missing from Petitioner’s stated motivation for modifying the array of Cantor is a reason why a POSA would seek to correlate the identification sequence with a location on the array at all. Prelim. Resp. 72. Indeed, the location of a bead on the substrate is not pertinent to the analysis disclosed in Cantor. Ex. 2002 ¶ 172; see also id. at ¶ 31 (Cantor “does not relate to the [spatial] analysis of tissue samples . . . .”). “[O]bviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed invention.” Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015). Here, Cantor fails to teach or suggest capture probes distributed randomly on a substrate comprising a nucleic acid sequence that identifies a unique location on the substrate as required by the challenged claims, and Petitioner fails to adequately articulate why a person of ordinary skill in the art would have modified Cantor to make the recited capture probes. In view of the above, we find that, on this record, Petitioner has failed to establish that Cantor teaches or suggests each element of the challenged claims. Accordingly, we determine that Petitioner has not demonstrated a reasonable likelihood of prevailing on its challenge that any of claims 1, 3, 6, 10, 11, 16, 18, 21, 24–26, and 30 would have been obvious over Cantor.” slip op. at 20

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

    “Petitioner does not argue that any claim term requires construction. Pet. 22–23. Likewise, Patent Owner takes the position that “no claim terms 2 Person of ordinary skill in the art. require explicit construction” for purposes of determining whether to institute inter partes review. Prelim. Resp. 19. Having considered the parties’ positions and evidence of record, we determine that no express construction of any claim term is necessary to determine whether to institute inter partes review. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 8

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

    “What is missing from Petitioner’s stated motivation for modifying the array of Cantor is a reason why a POSA would seek to correlate the identification sequence with a location on the array at all. Prelim. Resp. 72. Indeed, the location of a bead on the substrate is not pertinent to the analysis disclosed in Cantor. Ex. 2002 ¶ 172; see also id. at ¶ 31 (Cantor “does not relate to the [spatial] analysis of tissue samples . . . .”). “[O]bviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed invention.” Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015). Here, Cantor fails to teach or suggest capture probes distributed randomly on a substrate comprising a nucleic acid sequence that identifies a unique location on the substrate as required by the challenged claims, and Petitioner fails to adequately articulate why a person of ordinary skill in the art would have modified Cantor to make the recited capture probes. In view of the above, we find that, on this record, Petitioner has failed to establish that Cantor teaches or suggests each element of the challenged claims. Accordingly, we determine that Petitioner has not demonstrated a reasonable likelihood of prevailing on its challenge that any of claims 1, 3, 6, 10, 11, 16, 18, 21, 24–26, and 30 would have been obvious over Cantor.” slip op. at 20

  Claim construction§ 102 anticipation§ 103 obviousness
  Patents in suitUS 11,761,030

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.