• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  PTAB · Nov 17, 2025 · IPR2024-00648 · APJ Devon Zastrow Newman · IPR · Final written decision

  Claims 1–30 are unpatentable: claims 1–2, 4–7, 9–12, 14–17, and 19–30 are anticipated by the MSI-H Study Record; claims 3, 8, 13, and 18 are obvious over the cited combinations.

  RulingsFinal written decision

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

    “We agree with Patent Owner that the phrase “in response to” in claim 1 requires a causal relationship wherein the patient must be tested for MSI-H and, if he or she is determined to be MSI-H or dMMR, then the patient is treated with 10 mg/kg of pembrolizumab every 14 days. In claim 1, a biological sample from the patient must be tested to determine if the cancer is MSI-H and, if so, the patient is treated with a therapeutically effective amount of pembrolizumab. For this reason, if the prior art teaches the limitations of 1) testing a biological sample obtained from a patient having cancer to determine that the patient’s cancer is microsatellite instability high or mismatch repair deficient, and 2) treating the patient with a therapeutically effective amount of pembrolizumab if the patient’s cancer is determined to be microsatellite instability high or DNA mismatch repair deficient, the art anticipates claim 1. We are not persuaded that claim 1 requires or excludes anything else because nothing else is recited in the claim.” slip op. at 10

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityReference is prior artDecided for petitioner

    “Patent Owner does not direct us to evidence that it attempted to file any patent application before the publication date of the MSI-H clinical study and was denied an earlier filing date. Contrary to Patent Owner’s argument that it could not file a patent application without results from the MSI-H clinical study, we note that the inventors filed a provisional patent application on November 13, 2014, which, although also filed more than a year after the publication of the MSI-H clinical study, disclosed no clinical results or data. Ex. 1001, cover; Ex. 1030, 1. After considering the parties’ arguments, we are not persuaded by Patent Owner’s assertion that the inventors could not have filed an earlier application to at least attempt to secure a priority date before the MSI-H clinical study was publicly available. an earlier filing date. Instead, we are persuaded by Petitioner’s argument that because the MSI-H clinical study was published before the inventors filed an application to protect their patent rights the MSI-H clinical study is prior art for the information it discloses. Accordingly, we proceed to analyze Petitioner’s contentions in Ground 1.” slip op. at 24

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

    “the genus disclosed in the MSI Study Record and does not argue or provide evidence to show that one of ordinary skill in the art could have envisaged each species within that genus. PO Resp. 11–14. We are not persuaded that either the size of the genus in the MSI Study Record or whether one of ordinary skill in the art would have been able to envisage every species within it is dispositive of whether the MSI Study Record anticipates claim 1, where one of ordinary skill in the art would have known that specific cancers recited in claim 1 would be included in the MSI Study Record. As Petitioner argues, claim 1 requires that “a patient…selected from the group consisting of [the listed cancers]” be tested and treated. Pet. Reply 10 (emphasis original). Claim 1 does not require that the patient have each and every one of the sixteen listed cancers to anticipate the claim. Rather, claim 1 requires testing a sample from “a patient” with one of the recited types of cancer and treating the patient. See Brown v. 3M, 265 F.3d 1349, 1351 (Fed. Cir. 2001) (“When a claim covers several structures or compositions, either generically or as alternatives, the claim is deemed anticipated if any of the structures or compositions within the scope of the claim is known in the prior art.”).” slip op. at 31

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “In contrast, the testimony of Patent Owner’s witness, Dr. Goldberg, supports Petitioner’s argument of the knowledge in the art at the time, wherein Dr. Goldberg testifies that “[w]hile many clinical oncologists were aware that patients with Lynch Syndrome had a defect in DNA mismatch repair, they associated MSI testing with young onset colorectal and endometrial cancer and patients with a family history of colorectal and/or endometrial cancer.” Ex. 2090 ¶ 79. Similarly, during his deposition, Dr. Goldberg also agreed that endometrial, gastric, and small-bowel cancers would come to mind when he saw a reference to MSI-high non-colorectal cancer. See Ex. 1243, 115:5–116:22 (Q. And so does endometrial cancer come to mind when you see reference to MSI-high non-colorectal cancers? . . . A. Yes. Q. As . . . a person of skill in the field, when you see reference to MSI-high non-colorectal cancers, does gastric cancer come to mind? . . . A. comes to mind. So the answer is yes. Q. As a person of skill in the field, when you see reference to MSI-high non-colorectal cancers, does small bowel cancer come to mind? . . . A. Yes.”). Patent Owner does not direct us to other evidence contradicting Petitioner’s argument that MSI-H was known to occur in endometrial, small bowel, and gastric cancer. Pet. 18.” slip op. at 30

  Patent outcomesUS 11,643,462 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,643,462
• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  PTAB · Nov 6, 2025 · IPR2024-00623 · APJ Devon Zastrow Newman · IPR · Final written decision

  Claims 1–7 are unpatentable: claims 1–3 and 5–7 are anticipated by the MSI-H Study Record, and claim 4 is obvious over the MSI-H Study Record and other cited references.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “On balance, we find Petitioner’s evidence more persuasive of what one of ordinary skill in the art would have understood from the MSI-H Study Record. We find Dr. Neugut’s and Dr. Oberstein’s testimony, and Dr. Lonberg’s lack of clear testimony to the contrary, persuasive as to this issue. In addition, we are not persuaded by the case law cited by Patent Owner regarding inherent anticipation. See PO Resp. 6–7. Rather, we agree with Petitioner that the correct inquiry is whether the skilled artisan would have understood that all limitations are disclosed in the prior art. See Pet. 34–35; Pet. Reply 12–13. In light of the cited testimony, we are persuaded that Petitioner has met its burden of proving that a skilled artisan would reasonably have understood or inferred that the limitation for a patient having received a prior cancer therapy drug to treat the tumor was disclosed in the MSI-Study Record. Petitioner demonstrates what one of ordinary skill in the art would have understood from the MSI-H Study Record, not what it inherently discloses. Contra PO Resp. 6–9.” slip op. at 22

  • Skill levelSkill level board ownDecided for petitioner

    “In light of the extent of the relevant field, we determine that the level of skill in the art relevant to the claims of the ’974 patent is not limited to knowledge of and experience with conducting research relating to oncology or developing and conducting clinical trials, but includes knowledge of and experience with treating cancer patients with immunotherapy compounds, identifying the conditions these patients may have, and understanding the literature regarding clinical trials for such colorectal cancers and the associated conditions and immunotherapy.” slip op. at 9

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable

  Patent outcomesUS 11,325,974 unpatentable
  § 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,325,974
• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  PTAB · Nov 4, 2025 · IPR2024-00624 · APJ Sheridan K Snedden · IPR · Final written decision

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

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

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

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

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

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

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

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

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

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

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

  RulingsFinal written decision

  • BurdenUnpatentable

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

  • Skill levelSkill level board ownDecided for petitioner

    “Petitioner and Patent Owner characterize one of ordinary skill in the art differently. To Petitioner, the ordinarily skilled artisan would have been a medical doctor, or a professional in a related field, with experience treating cancer or access to those with experience in clinical studies of therapeutics and to a pathologist with this experience. Pet. 11 (citing Ex. 1003 ¶ 19). To Patent Owner, the ordinarily skilled artisan would have had a medical or graduate-level degree, or equivalent work experience, in the fields of immunology, genetics, or a related field and would have experience (i) conducting immunology research relating to oncology, (ii) conducting genetics research relating to oncology, or (iii) developing and conducting clinical trials on novel cancer therapies in those fields. PO Resp. 5–6 (citing Ex. 2072 ¶¶ 31–32, 86–94). Petitioner emphasizes medical and treatment aspects in its characterization of an ordinarily skilled artisan, whereas Patent Owner emphasizes research aspects. The ’356 patent claims a method of treating a human patient with cancer having certain characteristics using pembrolizumab and the main prior art reference cited by Petitioner, MSR, discloses testing Ex. 1005. Accordingly, the relevant field of Patent Owner’s claims is treating human patients for cancer, as well as testing existing compounds for use in treatment modalities. In light of the extent of the relevant field, we determine that the level of skill in the art relevant to the claims of the ’356 patent is not limited to knowledge of and experience with conducting research relating to oncology or developing and conducting clinical trials, but includes knowledge of and experience with treating cancer patients with immunotherapy compounds, identifying the conditions these patients may have, and understanding the literature regarding clinical trials for such colorectal cancers and the associated conditions and immunotherapy.” slip op. at 9

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

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

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

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

  Patent outcomesUS 10,934,356 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 10,934,356
• Tesla, Inc. v. Autonomous Devices, LLCSome claims unpatentable
  PTAB · Oct 21, 2025 · IPR2024-00745 · APJ Russell E Cass · IPR · Final written decision

  Claims 45–47, 51, 59, 60, 68, and 69 are unpatentable; claims 56 and 57 are not shown unpatentable. Substitute claims 85–88 and 91 are unpatentable; amendment is granted for claims 92 and 93.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “technical field, and the asserted prior art, we agree with Petitioner’s proposed qualifications for the person of ordinary skill in the art, except we decline to adopt “at least,” as that language is vague and open-ended. Otherwise, Petitioner’s proposed definition is consistent with the level of 3 Patent Owner does not present objective evidence of nonobviousness. skill reflected in the specification of the ’474 patent and the asserted prior art references. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). Accordingly, we adopt Petitioner’s assessment of the level of skill for one of ordinary skill in the art.” slip op. at 11

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

    “Petitioner states that “no formal constructions are presently necessary,” and that it “maps [the] prior art in this Petition in a manner consistent with Patent Owner’s allegations of infringement before the district court.” Pet. 8 (citing Ex. 1017; Ex. 1003 ¶¶ 21–25). Patent Owner states that it believes there is no need to construe any terms of the challenged original claims because there is no underlying controversy regarding any claim terms. PO Resp. 10. For purposes of this Decision, we determine that it is not necessary to provide an express construction of any claim terms. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017); Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”).” slip op. at 12

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

    “3. Motivation to Combine Buibas and Sinyavskiy Petitioner argues that “it would have been obvious to partition Buibas’[s] spiking networks according to the specific techniques disclosed in Sinyavskiy” for multiple reasons. Pet. 13 (citing Ex. 1005 ¶¶ 71–72, 85, 92, 179–203; Ex. 1006 ¶¶ 12, 185, 188, 191, Fig. 6A; Ex. 1003 ¶ 63). First, Petitioner asserts, one of ordinary skill “would have been motivated to partition Buibas’[s] spiking neural network as suggested by Sinyavskiy to parallelize task execution on the robot and improve learning capabilities (e.g., through faster learning, greater computing efficiency, and task-specific learning models) of the Buibas mobile robotic apparatus as described by Sinyavskiy and discussed by Dr. Janet.” Id. (citing Ex. 1003 ¶ 64). Second, Petitioner contends, “partitioning Buibas’[s] robotic brain as suggested by Sinyavskiy would have beneficially expanded the range of tasks that the robot could perform by dedicating partitions to specialized tasks.” Id. at 13– 14 (citing Ex. 1006 ¶¶ 12, 185, 188, Fig. 6A; Ex. 1005 ¶¶ 71–72, 85, 92, 179–205; Ex. 1003 ¶ 65). Third, Petitioner argues, one of ordinary skill “would have been motivated to partition Buibas’[s] spiking neural network as suggested by Sinyavskiy to permit unused partitions or unused resources in the partitions to be reassigned for different tasks,” which would allow for a network processing apparatus that has increased processing capability for the same network capacity while also having a lower cost, size and power consumption. Id. at 14 (citing Ex. 1006 ¶¶ 190–192, 105, 34, code (57); Ex. 1003 ¶ 66). Fourth, Petitioner argues that “Buibas briefly mentions that its spiking neural networks can be partitioned but discloses little detail about the partitioning,” which would invite one of ordinary skill to turn to other references, such as Sinyavskiy, for additional detail on how to implement partitioning. Pet. 14–15 (citing Ex. 1005 ¶ 92; Ex. 1003 ¶ 67). Fifth, Petitioner asserts, combining Buibas and Sinyavskiy would merely “involve[] the application of known techniques (e.g., Sinyavskiy’s partitioned neural network) to a known system (e.g., Buibas’[s] mobile robot and robotic brain) to yield predictable results (e.g., Buibas’[s] robot using a spiking neural network partitioned as taught in Sinyavskiy),” particularly because “the partitioning of the Buibas neural network is reminiscent of Recurrent Fuzzy Neural Networks (RFNNs) that were already commonplace at the end of the 1990’s.” Id. at 15 (citing Ex. 1003 ¶ 68). Finally, Petitioner contends, the proposed combination merely involves “use of known techniques (e.g., Sinyavskiy’s partitioned neural network) to improve a similar system (e.g., Buibas’[s] mobile robot and robotic brain).” Id. (citing Ex. 1003 ¶ 69). Petitioner further argues that one of ordinary skill “would have reasonably expected success implementing the combination, especially as Buibas and Sinyavskiy describe highly similar systems involving spiking neural networks used for training/operating robots.” Pet. 15–16 (citing Ex. 1005 ¶ 92; Ex. 1003 ¶ 70). Indeed, Petitioner contends, “Buibas itself confirms that its spiking neural network can be partitioned, while Sinyavskiy provides the details for doing so.” Id. at 16 (citing Ex. 1005 ¶ 92; Ex. 1003 ¶ 70).” slip op. at 14

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

    “We agree with Patent Owner and Dr. Saber that these “weights” are numerical values associated with connections among neurons, and the “weight vectors” are merely lists of weights. PO Resp. 13–14; Ex. 2001 ¶¶ 66–67. When input is provided to the neural network, the network uses the weights of its connections in a feedforward calculation manner to provide an output that can include an instruction for operating a device. Ex. 2001 ¶ 66. We agree with and find credible Dr. Saber’s testimony that Buibas’s merging of weights or weight vectors results in updated network weights, and does not, by itself, disclose the merging of instruction sets for operating a device, or the correlation of the same set of inputs for all or a portion of a circumstance representation with instruction sets for operating two different devices. Ex. 2001 ¶¶ 65, 67, 69–71.” slip op. at 39

  Patent outcomesUS 11,663,474 mixed
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,663,474
• Meta Platforms, Inc. v. Mullen Industries LLCInstituted
  PTAB · Oct 16, 2025 · IPR2025-00702 · APJ Ken B Barrett · IPR · Institution

  The Board instituted review of claims 4, 5, 16, 17, and 19 on all asserted grounds after finding a reasonable likelihood that claim 4 was obvious over Nakamura and Benini.

  RulingsInstitution decision

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

    “An inter partes review may not be instituted “unless . . . the information presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2023). Having considered the arguments and evidence presented by Petitioner and Patent Owner, we determine that Petitioner has demonstrated a reasonable likelihood of prevailing on at least one of the challenged claims of the ’270 patent. Accordingly, we institute an inter partes review as to all the challenged claims of the ’270 patent on all the grounds of unpatentability set forth in the Petition.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “A person of ordinary skill in the art (“POSITA”) in 2004 would have had at least a bachelor’s degree in electrical engineering, computer science, or a similar field, with at least two years of relevant experience working with VR [virtual reality] and AR [augmented reality] systems. Additional experience could substitute for less education, and additional education could likewise substitute for less experience. Pet. 27 (citing Welch Decl. ¶¶ 88–90, 91). Patent Owner, at this stage, does not disagree or propose a different definition of the person of ordinary skill in the art. Petitioner’s definition is consistent with the level of ordinary skill reflected in the prior art references of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (recognizing that the prior art itself may reflect an appropriate level of skill in the art). For purposes of this decision, we apply Petitioner’s definition of the person of ordinary skill in the art.” slip op. at 7

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

    “(citing Phillips, 415 F.3d at 1312–17). “[W]hile extrinsic evidence can shed useful light on the relevant art, . . . it is less significant than the intrinsic record in determining the legally operative meaning of claim language.” Phillips, 415 F.3d at 1317 (internal quotation marks omitted). We construe expressly only those claim terms that require analysis to determine whether to institute inter partes review. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (holding that “only those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy”). Petitioner contends that “[t]his Petition establishes the prior art meets each of the claim limitation[s] under any reasonable construction,” and, “[t]hus, no express construction is required.” Pet. 27–28. Patent Owner’s Preliminary Response does not contain a separate claim construction section. On this record and for purposes of this decision, we determine that no claim terms require express construction.” slip op. at 8

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

    “1. Setting an origin location Limitation 4.a.1 recites, “a first manual input for setting a[n] origin location setting for a location reference for gameplay.” Ex. 1001, 24:44–46. Patent Owner argues that Petitioner has not shown that this limitation disclosed or rendered obvious by the relied-on references. See Prelim. Resp. 29. Petitioner contends that Nakamura teaches the user’s manual selection of a starting point of a game. Pet. 38–40 (citing, inter alia, Welch Decl. ¶¶ 147–148; Ex. 1007 ¶¶ 9, 35–36, Fig. 5); see also id. at 62 (for this Ground 2, referencing the contentions made for Ground 1). Petitioner further contends that “[a] POSITA would have also recognized that the initial position setting provides a location reference for gameplay.” Id. at 63. For this Ground 2, Patent Owner incorporates by reference its arguments regarding Ground 1 based on Cheok, Nakamura, and Foxlin077. See Prelim. Resp. 29. Patent Owner argues that “Nakamura’s position icon 113 [displayed at a virtual location appropriate for the initial position] represents a virtual character’s virtual location in the virtual world, rather than a user’s physical location, and has no relationship to the physical location.” Prelim. Resp. 24 (citing Ex. 1038 ¶¶ 36, 38). According to Patent Owner, “establishing a physical origin location as a location reference is critical to key features of the patented system.” Id. at 25 (citing Section III of the Preliminary Response). Patent Owner’s argument is not commensurate in scope with the language of claim 4, which recites an input for setting “a[n] origin location,” not “a physical origin location.” In support of its arguments, Patent Owner relies on the Specification, stating, for example, that “[t]he ’270 patent’s system ‘prompt[s] a user to” slip op. at 9

  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,967,270
• Meta Platforms, Inc. v. Mullen Industries LLCInstituted
  PTAB · Oct 15, 2025 · IPR2025-00703 · APJ Ken B Barrett · IPR · Institution

  The Board instituted IPR on claims 1, 4, 11, 16, 30, and 102 on all asserted grounds, finding a reasonable likelihood that claim 1 is obvious over Cheok and Foxlin077.

  RulingsInstitution decision

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

    “persuasive for several reasons. As an initial matter, the claim does not recite “a bounded physical play space.” Rather, the claim recites “a physical playfield.”” slip op. at 9

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “A person of ordinary skill in the art (“POSITA”) in 2004 would have had at least a bachelor’s degree in electrical engineering, computer science, or similar field, with at least two years of relevant experience working with VR [Virtual Reality] and AR [Augmented Reality] systems. Additional experience could substitute for less education, and additional education could likewise substitute for less experience. Welch ¶95; see also ¶¶94. Pet. 17. Patent Owner, at this stage, does not disagree or propose a different definition of the person of ordinary skill in the art. Petitioner’s definition is consistent with the level of ordinary skill reflected in the prior art references of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (recognizing that the prior art itself may reflect an appropriate level of skill in the art). For purposes of this decision, we apply Petitioner’s definition of the person of ordinary skill in the art.” slip op. at 6

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

    “references’ teachings. Prelim. Resp. 36–38. Patent Owner specifically argues that “[t]here is no motivation to modify Cheok’s method for allegedly determining the direction of gameplay to include a prompt requesting a manually provided direction; it already allegedly determines direction by the user’s simple movement, which the user will already do while playing the game, a much more efficient process.” Id. at 36 (citing Pet., 29–36). According to Patent Owner, “[a]dding a prompt requesting manual user input for a direction of gameplay has drawbacks to user experience; it slows down the beginning of gameplay and complicates the overall system, removing the natural feel of playing without having to set up the game, when Cheok already works for its intended purpose.” Id. at 36–37. We do not find these arguments persuasive at this stage. Even if Patent Owner is correct that the proposed combination would be less efficient or slow down the beginning of play, that there may be drawbacks from the proffered combination of teachings does not necessarily show a lack of motivation to combine teachings. Winner Int’l Royalty Corp. v. Wang, 202 F.3d 1340, 1349 (Fed. Cir. 2000). And, even if the proposed combination would not have been the best choice, that does not necessarily mean that it was non-obvious. See Intel Corp. v. Qualcomm Inc., 21 F.4th 784, 800 (Fed. Cir. 2021) (“It’s not necessary to show that a combination is ‘the best option, only that it be a suitable option.’” (quoting PAR Pharm., Inc. v. TWI Pharms., Inc., 773 F.3d 1186, 1197–98 (Fed. Cir. 2014)). Dr. Welch testifies, for example, that “[a] POSITA would have . . . recognized it would be beneficial to improve the Cheok system by implementing a similar inertial sensor initialization/reinitialization process [as in Foxlin077] to address any potential accuracy or user experience issues associated with drift.” Welch Decl. ¶ 156. Dr. Welch also testifies that, “in a virtual environment application like the Cheok system, in which a user must interact with the real environment, a POSITA would have understood that Foxlin077’s manual reinitialization process would be beneficial to address accumulated drift when an automatic drift compensator component is not sufficiently removing drift.” Id. ¶ 157. At this stage, that testimony is unrebutted with evidence, as opposed to mere attorney argument.” slip op. at 16

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

    “information presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2023). Having considered the arguments and evidence presented by Petitioner and Patent Owner, we determine that Petitioner has demonstrated a reasonable likelihood of prevailing on at least one of the challenged claims of the ’821 patent. Accordingly, we institute an inter partes review as to all the challenged claims of the ’821 patent on all the grounds of unpatentability set forth in the Petition.” slip op. at 2

  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,033,821
• Intel Corporation v. Telefonaktiebolaget LM Ericsson (Publ)Some claims unpatentable
  PTAB · Oct 8, 2025 · IPR2024-00728 · APJ Russell E Cass · IPR · Final written decision

  Claims 1–5, 7, 8, 10–15, and 17–19 are unpatentable as obvious; claims 6, 9, and 16 are not shown unpatentable because the Midya-based grounds fail on the terminal limitation.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Based on the full trial record, we continue to adopt Petitioner’s definition of the level of ordinary skill in the art, which is consistent with the ’430 patent and the prior art. In adopting this definition, we note that neither the title nor the “Field of the Invention” portions of the ’430 patent limit the invention to integrated circuits, and Patent Owner does not dispute that claim 1 encompasses inductors that are not provided on an integrated circuit. Ex. 1001, code (54), 1:16–22. Additionally, Dr. Prucnal’s definitions have shifted, and his latest definition purports to be based on Dr. Tentzeris’s characterization of the level of ordinary skill, but changes “experience designing integrated circuits or inductors for semiconductors” to “experience designing integrated circuits and inductors for semiconductors” without sufficient explanation of the reasons for the change. Supp. Prucnal Decl. ¶ 8; Reply Tentzeris Decl. ¶ 56. However, our Decision in this case would not change under Patent Owner’s revised articulation. See Reply Tentzeris Decl. ¶ 57 (stating that his opinion would not change under Patent Owner’s revised definition of the level of ordinary skill).” slip op. at 9

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner

    “After considering the full trial record, we agree with Petitioner that the phrase “on a semiconductor die” in the preamble of claim 11 is not limiting. First, we determine that the phrase “on a semiconductor die” in claim 11 does not provide antecedent basis for terms in the body of the claim. The body of claim 11 does not refer to “the semiconductor die” or even mention the “semiconductor die” at all, and neither do any of the claims that depend from claim 11. We disagree with Patent Owner’s argument that the phrase “on a semiconductor die” in the preamble of claim 11 provides antecedent basis for the term “the first inductor” in the body of the claim, because the “first inductor” language in the preamble provides antecedent basis for “the first inductor” language in the claim’s body. The “on a semiconductor die” language in the preamble is presented separately and can be easily parsed from the preamble’s language reciting a “first inductor” without impacting the understandability or grammatical completeness of claim 11. Therefore, the “on a semiconductor die” language in claim 11’s preamble is not necessary to provide antecedent basis for the phrase “the first inductor” in the body of claim 11. This use of language in claim 11 is distinguishable from the Federal Circuit’s opinion in Deere v. Bush Hog, cited by Patent Owner, where the preamble term “rotary cutter deck” provided antecedent basis for the term “said deck” recited in the claim body, because in Deere, the words “rotary cutter” appeared directly before, directly modified, and were not easily parsed from the term “deck.” See Deere & Co. v. Bush Hog, LLC, 703 F.3d 1349, 1357–58 (Fed. Cir. 2012); PO Resp. 7–8.” slip op. at 12

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

    “We agree with Petitioner that claims 1 and 11 do not require that the first and second inductor be laterally spaced, but instead merely require that the second inductor be positioned at a “predetermined distance” from the first inductor. Nothing in the claim language restricts this “predetermined distance” from being in the X, Y, or Z direction, or requires that the inductors be laterally spaced in the same plane. Moreover, the fact that the ’430 patent Specification describes embodiments where the inductors are laterally spaced in the same plane does not limit the claims to those embodiments. As explained previously, our reviewing court “has expressly rejected the contention that if a patent describes only a single embodiment, the claims of the patent must be construed as being limited to that embodiment.” Liebel-Flarsheim, 358 F.3d at 906. “Even when the specification describes only a single embodiment, the claims of the patent will not be read restrictively unless the patentee has demonstrated a clear intention to limit the claim scope using ‘words or expressions of manifest exclusion or restriction.’” Id. We see no such “words or expressions of manifest exclusion or restriction” here. Accordingly, we give the term “predetermined distance” its ordinary meaning, which includes a distance in any direction. The parties do not dispute that Taniguchi’s inductors are spaced apart with an insulation layer in between. Therefore, under the ordinary meaning of the claim language, Taniguchi’s second inductor is “positioned at a predetermined distance from the first inductor.”” slip op. at 26

  • Prior constructionPrior construction adoptedDecided for patent owner

    “We agree with and adopt the ITC’s construction of “closely spaced,” which is “two terminals in proximity to each other (such that the electromagnetic field at a certain distance from the first inductor (where the second inductor is positioned) is reduced.” Ex. 1020, 12. We find that this construction is supported by the intrinsic record, including the Specification of the ’430 patent, which shows terminals being “closely spaced” compared to the dimensions of the inductor itself, and explains that the purpose of the close spacing is to make the field contributions from the two parts of the inductor identical. See Ex. 1005, Figs. 1–2, 4:28–32. Claims 1 and 11 of the ’430 patent lack specific dimensions for either the inductor or the spacing between the terminals, and indicate that the purpose of the close spacing is to “minimiz[e] magnetic field contributions from the terminals.” Ex. 1001, 10:22–25, 11:7–10. Dr. Prucnal’s ITC declaration, although not intrinsic evidence, further supports our conclusion. Although Patent Owner does not propose a construction for “closely spaced terminals,” it appears to argue that this term must be interpreted based on the dimensions of the semiconductor chip described in the ’430 patent. PO Resp. 43. We do not see any basis in the intrinsic or extrinsic evidence to impart such a narrow reading to the claim language, particularly because the ’430 patent Specification does not define the “closely spaced terminals” in relation to a semiconductor chip, and claim 1 is not limited to inductors on a semiconductor chip.” slip op. at 40

  Patent outcomesUS 7,151,430 mixed
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 7,151,430
• 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

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.