- Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · Nov 17, 2025 · IPR2024-00648 · APJ Devon Zastrow Newman · IPR · Final written decision
Claims 1–30 are unpatentable: claims 1–2, 4–7, 9–12, 14–17, and 19–30 are anticipated by the MSI-H Study Record; claims 3, 8, 13, and 18 are obvious over the cited combinations.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“We agree with Patent Owner that the phrase “in response to” in claim 1 requires a causal relationship wherein the patient must be tested for MSI-H and, if he or she is determined to be MSI-H or dMMR, then the patient is treated with 10 mg/kg of pembrolizumab every 14 days. In claim 1, a biological sample from the patient must be tested to determine if the cancer is MSI-H and, if so, the patient is treated with a therapeutically effective amount of pembrolizumab. For this reason, if the prior art teaches the limitations of 1) testing a biological sample obtained from a patient having cancer to determine that the patient’s cancer is microsatellite instability high or mismatch repair deficient, and 2) treating the patient with a therapeutically effective amount of pembrolizumab if the patient’s cancer is determined to be microsatellite instability high or DNA mismatch repair deficient, the art anticipates claim 1. We are not persuaded that claim 1 requires or excludes anything else because nothing else is recited in the claim.” slip op. at 10
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityReference is prior artDecided for petitioner
“Patent Owner does not direct us to evidence that it attempted to file any patent application before the publication date of the MSI-H clinical study and was denied an earlier filing date. Contrary to Patent Owner’s argument that it could not file a patent application without results from the MSI-H clinical study, we note that the inventors filed a provisional patent application on November 13, 2014, which, although also filed more than a year after the publication of the MSI-H clinical study, disclosed no clinical results or data. Ex. 1001, cover; Ex. 1030, 1. After considering the parties’ arguments, we are not persuaded by Patent Owner’s assertion that the inventors could not have filed an earlier application to at least attempt to secure a priority date before the MSI-H clinical study was publicly available. an earlier filing date. Instead, we are persuaded by Petitioner’s argument that because the MSI-H clinical study was published before the inventors filed an application to protect their patent rights the MSI-H clinical study is prior art for the information it discloses. Accordingly, we proceed to analyze Petitioner’s contentions in Ground 1.” slip op. at 24
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“the genus disclosed in the MSI Study Record and does not argue or provide evidence to show that one of ordinary skill in the art could have envisaged each species within that genus. PO Resp. 11–14. We are not persuaded that either the size of the genus in the MSI Study Record or whether one of ordinary skill in the art would have been able to envisage every species within it is dispositive of whether the MSI Study Record anticipates claim 1, where one of ordinary skill in the art would have known that specific cancers recited in claim 1 would be included in the MSI Study Record. As Petitioner argues, claim 1 requires that “a patient…selected from the group consisting of [the listed cancers]” be tested and treated. Pet. Reply 10 (emphasis original). Claim 1 does not require that the patient have each and every one of the sixteen listed cancers to anticipate the claim. Rather, claim 1 requires testing a sample from “a patient” with one of the recited types of cancer and treating the patient. See Brown v. 3M, 265 F.3d 1349, 1351 (Fed. Cir. 2001) (“When a claim covers several structures or compositions, either generically or as alternatives, the claim is deemed anticipated if any of the structures or compositions within the scope of the claim is known in the prior art.”).” slip op. at 31
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“In contrast, the testimony of Patent Owner’s witness, Dr. Goldberg, supports Petitioner’s argument of the knowledge in the art at the time, wherein Dr. Goldberg testifies that “[w]hile many clinical oncologists were aware that patients with Lynch Syndrome had a defect in DNA mismatch repair, they associated MSI testing with young onset colorectal and endometrial cancer and patients with a family history of colorectal and/or endometrial cancer.” Ex. 2090 ¶ 79. Similarly, during his deposition, Dr. Goldberg also agreed that endometrial, gastric, and small-bowel cancers would come to mind when he saw a reference to MSI-high non-colorectal cancer. See Ex. 1243, 115:5–116:22 (Q. And so does endometrial cancer come to mind when you see reference to MSI-high non-colorectal cancers? . . . A. Yes. Q. As . . . a person of skill in the field, when you see reference to MSI-high non-colorectal cancers, does gastric cancer come to mind? . . . A. comes to mind. So the answer is yes. Q. As a person of skill in the field, when you see reference to MSI-high non-colorectal cancers, does small bowel cancer come to mind? . . . A. Yes.”). Patent Owner does not direct us to other evidence contradicting Petitioner’s argument that MSI-H was known to occur in endometrial, small bowel, and gastric cancer. Pet. 18.” slip op. at 30
Patent outcomesUS 11,643,462 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,643,462 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · Nov 4, 2025 · IPR2024-00624 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1–4, 6–10, and 12–15 are unpatentable, principally because the MSI-H Study Record anticipates them.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“Pet. 12 (citing Ex. 1003 ¶ 19). To Patent Owner, the ordinarily skilled artisan would have had a medical or graduate-level degree, or equivalent work experience, in the fields of immunology, genetics, or a related field and would have experience (i) conducting immunology research relating to oncology, (ii) conducting genetics research relating to oncology, or (iii) developing and conducting clinical trials on novel cancer therapies in those fields. PO Resp. 6 (citing Ex. 2072 ¶¶ 31–32, 86–94). Thus, Petitioner and Patent Owner characterize one of ordinary skill in the art differently. Petitioner emphasizes medical and treatment aspects in its characterization of an ordinarily skilled artisan, whereas Patent Owner emphasizes research aspects.” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The parties do not assert constructions of any terms recited in the challenged claims other than that their ordinary and customary meanings should apply. Pet. 11–12; PO Resp. 6. We determine that no express construction of any claim term is necessary to resolve the dispute between the parties. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We construe” slip op. at 7
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“record, we are persuaded that the results recited in claim 1 would follow from the steps taught in the MSR, for the reasons and based on the evidence Petitioner cites above. For these same reasons, we are unpersuaded by Patent Owner’s argument that it was unknown whether the amount of pembrolizumab recited in claim 1 would be effective in producing an improved outcome compared to a reference patient without a tumor that was not MSI-H or dMMR, and Patent Owner does not dispute that the amount of pembrolizumab disclosed in the MSR (10 mg/kg every 14 days; see Ex. 1005, 4) is the same as the amount provided in the ’975 patent as being effective (10 mg/kg every 14 days; Ex. 1001, 8:48–52, 13:50–52). Regardless of the inventors’ intent in publishing the MSR as a Stage II clinical trial on the www.clinicaltrials.gov website, as discussed above, we determine that the MSR teaches selecting a patient with a metastatic MSI-H or dMMR tumor and administering an amount of pembrolizumab that would be effective. See, e.g., Ex. 1005, 4 (Arms and Interventions). The result of drug treatment inherently follows its administration. The MSR does not merely suggest that pembrolizumab may be useful in some unidentified subset of patients or suggest that some unidentified drug may be useful for MSI-H cancer patients. Instead, the MSR discloses selecting a patient with a condition recited in claim 1 and treating with the drug at the amount recited in claim 1. Contra Metabolite Labs. Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1367 (Fed. Cir. 2004) (holding that the prior art did not inherently anticipate where it failed to mention specific vitamin deficiencies, instead merely inviting further experimentation to find associations with metabolic perturbations). requirement, efficacy is inherent in carrying out the claim steps,” referring to a claimed method of treating or preventing stroke, which was held to be anticipated by the publication of a proposed study. 677 F.3d at 1381. Patent Owner attempts to distinguish the size and apparent surety of the study in Montgomery from the MSR. PO Resp. 15. But because we find that the MSR teaches performing the steps recited in claim 1 for the purpose of determining and treating MSI-H cancer, we are persuaded that the MSR inherently discloses the results of selection of patients and administration of the drug treatment recited in those steps. See Bristol-Myers, 246 F.3d at 1376. Whether or not the MSR could have provided results or was sufficient for full regulatory approval does not change that the MSR teaches Patent Owner’s claimed steps. We have no reason to doubt that the disclosure in the MSR of the steps recited in claim 1 produces the efficacy element required in claim 1, whether or not this efficacy was disclosed in the MSR or was known when it was published. See Mehl/Biophile, 192 F.3d at 1366 (“Where, as here, the result is a necessary consequence of what was deliberately intended, it is of no import that the article’s authors did not appreciate the results.”).” slip op. at 21
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“use that does not qualify as prior art. PO Resp. 18–25. Patent Owner argues that an inventor can be granted latitude to experiment in the public eye until her invention is ready for patenting. Id. at 18 (citing Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 64 (1998). According to Patent Owner, the experimental use negation applies to the MSR under a 13-factor analysis provided in Allen Engineering Corp. v. Bartell Industries, Inc., 299 F.3d 1336, 1353 (Fed. Cir. 2002). PO Resp. 19–25. For example, Patent Owner argues that to establish that treatment of MSI-H cancers was effective, the inventors had to test treatment in humans, there being no animal models, and had to publish the MSR on the government website under federal law. Id. at 20–22. Patent Owner argues further that the inventors had control over the MSI-H clinical study and that the field of cancer treatment was highly unpredictable, among other facts. Id. at 21. Patent Owner argues that “[a]t the time of the MSR’s posting, the claimed invention was not, nor could it have been, ready for patenting. The clinical study that ultimately collected the data reported in the patent specification and supporting the patent claims had not and could not have commenced before the MSR was posted.” Id. at 23. sometimes said that an inventor acquires an undue advantage over the public by delaying to take out a patent, inasmuch as he thereby preserves the monopoly to himself for a longer period than is allowed by the policy of the law,” but held that “when the delay is occasioned by a bona fide effort to bring his invention to perfection, or to ascertain whether it will answer the purpose intended,” the experiment use exception can preserve the inventor’s rights. City of Elizabeth v. Am. Nicholson Pavement Co., 97 U.S. 126, 137 (1877). Because we are not persuaded that Patent Owner could not have filed an earlier application, we are not persuaded that the experimental use doctrine is properly applied in this case. Given that clinical trial protocols published on the ClinicalTrials.gov website have been successfully asserted as prior art in other cases, we are not persuaded by Patent Owner’s arguments that the MSR is not available as prior art against the challenged claims. See, e.g., Salix Pharms., Ltd. v. Norwich Pharms. Inc., 98 F.4th 1056, 1061 (Fed. Cir.), cert. denied, 145 S. Ct. 567 (2024), and cert. denied, 145 S. Ct. 983 (2024).” slip op. at 24
Patent outcomesUS 11,325,975 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,325,975 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · Oct 28, 2025 · IPR2024-00622 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1–28 are unpatentable: claims 1, 6–11, 13–20, 22–24, and 26–28 as anticipated by the MSI-H Study Record; claims 2–5, 12, 21, and 25 as obvious.
RulingsFinal written decision- BurdenUnpatentable
“(“the claimed process here is not directed to a new use; it is the same use, and it consists of the same steps as described by [the prior art]. Newly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.”). After analysis of the full record, we are persuaded that the results recited in claim 1 would follow from the steps taught in the MSR, for the reasons and based on the evidence Petitioner cites above. For these same reasons, we are unpersuaded by Patent Owner’s argument that it was unknown whether the amount of pembrolizumab recited in claim 1 would be effective in producing an improved outcome compared to a reference patient without a tumor that was not MSI-H or dMMR, and Patent Owner does not dispute that the amount of pembrolizumab disclosed in the MSR (10 mg/kg every 14 days; see Ex. 1005, 4) is the same as the amount provided in the ’356 patent as being effective (10 mg/kg every 14 days; Ex. 1001, 8:48–52, 13:50–52). Regardless of the inventors’ intent in publishing the MSR as a Stage II clinical trial on the www.clinicaltrials.gov website, as discussed above, we determine that the MSR teaches selecting a patient with a metastatic MSI-H or dMMR tumor and administering an amount of pembrolizumab that would be effective. See, e.g., Ex. 1005, 4 (Arms and Interventions). The result of drug treatment inherently follows its administration. The MSR does not merely suggest that pembrolizumab may be useful in some unidentified subset of patients or suggest that some unidentified drug may be useful for MSI-H cancer patients. Instead, the MSR discloses selecting a patient with a condition recited in claim 1 and treating with the drug at the amount recited in claim 1. Contra Metabolite Labs. Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1367 (Fed. Cir. 2004) (holding that the prior art did not” slip op. at 22
- Skill levelSkill level board ownDecided for petitioner
“Petitioner and Patent Owner characterize one of ordinary skill in the art differently. To Petitioner, the ordinarily skilled artisan would have been a medical doctor, or a professional in a related field, with experience treating cancer or access to those with experience in clinical studies of therapeutics and to a pathologist with this experience. Pet. 11 (citing Ex. 1003 ¶ 19). To Patent Owner, the ordinarily skilled artisan would have had a medical or graduate-level degree, or equivalent work experience, in the fields of immunology, genetics, or a related field and would have experience (i) conducting immunology research relating to oncology, (ii) conducting genetics research relating to oncology, or (iii) developing and conducting clinical trials on novel cancer therapies in those fields. PO Resp. 5–6 (citing Ex. 2072 ¶¶ 31–32, 86–94). Petitioner emphasizes medical and treatment aspects in its characterization of an ordinarily skilled artisan, whereas Patent Owner emphasizes research aspects. The ’356 patent claims a method of treating a human patient with cancer having certain characteristics using pembrolizumab and the main prior art reference cited by Petitioner, MSR, discloses testing Ex. 1005. Accordingly, the relevant field of Patent Owner’s claims is treating human patients for cancer, as well as testing existing compounds for use in treatment modalities. In light of the extent of the relevant field, we determine that the level of skill in the art relevant to the claims of the ’356 patent is not limited to knowledge of and experience with conducting research relating to oncology or developing and conducting clinical trials, but includes knowledge of and experience with treating cancer patients with immunotherapy compounds, identifying the conditions these patients may have, and understanding the literature regarding clinical trials for such colorectal cancers and the associated conditions and immunotherapy.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The parties do not assert constructions of any terms recited in the challenged claims other than that their ordinary and customary meanings should apply. Pet. 10–11; PO Resp. 6. We determine that no express construction of any claim term is necessary to resolve the dispute between the parties. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We construe claims “in accordance with the ordinary and customary meaning of such history pertaining to the patent.” 37 C.F.R. § 42.100(b) (2020).” slip op. at 8
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency foundUnpatentable
“(“the claimed process here is not directed to a new use; it is the same use, and it consists of the same steps as described by [the prior art]. Newly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.”). After analysis of the full record, we are persuaded that the results recited in claim 1 would follow from the steps taught in the MSR, for the reasons and based on the evidence Petitioner cites above. For these same reasons, we are unpersuaded by Patent Owner’s argument that it was unknown whether the amount of pembrolizumab recited in claim 1 would be effective in producing an improved outcome compared to a reference patient without a tumor that was not MSI-H or dMMR, and Patent Owner does not dispute that the amount of pembrolizumab disclosed in the MSR (10 mg/kg every 14 days; see Ex. 1005, 4) is the same as the amount provided in the ’356 patent as being effective (10 mg/kg every 14 days; Ex. 1001, 8:48–52, 13:50–52). Regardless of the inventors’ intent in publishing the MSR as a Stage II clinical trial on the www.clinicaltrials.gov website, as discussed above, we determine that the MSR teaches selecting a patient with a metastatic MSI-H or dMMR tumor and administering an amount of pembrolizumab that would be effective. See, e.g., Ex. 1005, 4 (Arms and Interventions). The result of drug treatment inherently follows its administration. The MSR does not merely suggest that pembrolizumab may be useful in some unidentified subset of patients or suggest that some unidentified drug may be useful for MSI-H cancer patients. Instead, the MSR discloses selecting a patient with a condition recited in claim 1 and treating with the drug at the amount recited in claim 1. Contra Metabolite Labs. Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1367 (Fed. Cir. 2004) (holding that the prior art did not” slip op. at 22
Patent outcomesUS 10,934,356 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,934,356 - Valve Corporation v. Immersion CorporationAll claims unpatentablePTAB · Oct 24, 2025 · IPR2024-00714 · APJ Christopher L Ogden · IPR · Final written decision
Claims 1–20 are unpatentable: Goldenberg anticipates or renders claims 1–6, 8–13, and 15–19 obvious, and Goldenberg with Cruz-Hernandez renders claims 7, 14, and 20 obvious.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“The parties’ proposed levels of ordinary skill are substantially similar, supported by testimonial evidence, and consistent with the asserted prior art and the types of problems and solutions in the ’907 patent. See, e.g., Ex. 1001, 1:14–62. Because we discern no dispositive difference between the parties’ proposals, and neither party has argued that the choice between the two would affect the outcome,6 we adopt Petitioner’s proposed level of skill for this decision. We note, however, that our decision would be the same under Patent Owner’s proposal.” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner
“to,” as recited in each of claims 1, 8, and 15, to “require[] a cause-and-effect relationship between a secondary event (e.g., a haptic effect) that occurs in reaction to a first event (e.g., entry of the user input element to one or more positions within the boundary range of positions).” PO Resp. 26–27 (citing Ex. 2004 ¶ 44). Patent Owner argues that “in response to” refers to more than just a coincidence and involves at least some degree of causality. Id. at 27 (citing American Calcar, Inc. v. American Honda Motor Co., 651 F.3d 1318, 1339–40 (Fed. Cir. 2011); Ex. 2007, 12–14 (dictionary definition); Ex. 2008, 7 (dictionary definition); Ex. 2006, 30:13–31:2, 32:8–11, 32:17– 21 (testimony by Mr. Ward)); PO Sur-reply 8–9 (citing Ex. 2009, 34:8–19, 36:5–21 (testimony by Mr. Ward)).” slip op. at 17
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionDecided for patent owner
“to,” as recited in each of claims 1, 8, and 15, to “require[] a cause-and-effect relationship between a secondary event (e.g., a haptic effect) that occurs in reaction to a first event (e.g., entry of the user input element to one or more positions within the boundary range of positions).” PO Resp. 26–27 (citing Ex. 2004 ¶ 44). Patent Owner argues that “in response to” refers to more than just a coincidence and involves at least some degree of causality. Id. at 27 (citing American Calcar, Inc. v. American Honda Motor Co., 651 F.3d 1318, 1339–40 (Fed. Cir. 2011); Ex. 2007, 12–14 (dictionary definition); Ex. 2008, 7 (dictionary definition); Ex. 2006, 30:13–31:2, 32:8–11, 32:17– 21 (testimony by Mr. Ward)); PO Sur-reply 8–9 (citing Ex. 2009, 34:8–19, 36:5–21 (testimony by Mr. Ward)).” slip op. at 17
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“To show anticipation under § 102, a petitioner must locate every element in a claim, arranged as recited in the claim, in a single prior art reference. See Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008). The limitations may be present in the reference “either explicitly or inherently.” In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). In making this determination, we consider the reference “together with the knowledge of one of ordinary skill in the pertinent art.” In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994) (citing In re Samour, 571 F.2d 559, 562 (CCPA 1978)).” slip op. at 18
Patent outcomesUS 10,627,907 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,627,907 - PTAB · Oct 8, 2025 · IPR2025-00629 · APJ Scott C Moore · IPR · Institution
The Board instituted IPR of claims 1–20 on all asserted grounds, finding a reasonable likelihood that claim 1 is obvious over Beard and Laufer.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We may institute an inter partes review when “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). If we institute an inter partes review, the trial must encompass all claims and grounds identified in the Petition. 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”). For the reasons set forth below, we conclude that there is a reasonable likelihood that Petitioner will prevail in establishing the unpatentability of one or more claims of the ’711 Patent. We, therefore, institute inter partes review of claims 1–20 on the grounds identified in the Petition. B.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that one of ordinary skill in the art would have had the following qualifications: [E]ither (1) a Bachelor of Science in Mechanical Engineering, Electrical Engineering, Aerospace engineering, or an equivalent field, as well as at least 2 years of academic or industry experience in the aerospace or avionics fields, or (2) at least four years of experience in any of the above industries. 1 The Leahy-Smith America Invents Act (“AIA”) included revisions to 35 U.S.C. §§ 102 and 103 that became effective on March 16, 2013. Because the applications from which the ’711 Patent claims priority were all filed after this date, the post-AIA version of §103 applies. See Ex. 1001, codes (60), (63). 2 U.S. Patent No. 9,769,387 B1, iss. Sept. 19, 2017 (Ex. 1009). 3 U.S. Patent App. Pub. No. 2017/0059692 A1, pub. Mar. 2, 2017 (Ex. 1010). 4 U.S. Patent App. Pub. No. 2012/0106800 A1, pub. May 3, 2012 (Ex. 1021). 5 U.S. Patent App. Pub. No. 2017/0161911 A1, pub. June 8, 2017 (Ex. 1007). 6 U.S. Patent App. Pub. No. 2013/0301905 A1, pub. Nov. 14, 2013 (Ex. 1024). 7 U.S. Patent App. Pub. No. 2012/0004844 A1, pub. Jan. 5, 2012 (Ex. 1025). 8 PCT App. Pub. No. WO 2017/123477 A1, pub. July 20, 2017 (Ex. 1022). 9 U.S. Patent App. Pub. No. 2017/0160751 A1, pub. June 8, 2017 (Ex. 1005). Pet. 8 (citing Ex. 1003 ¶¶ 50–54). Patent Owner does not presently dispute Petitioner’s proposed formulation. See generally Prelim. Resp. For purposes of this Decision, we adopt and apply Petitioner’s formulation regarding the level of ordinary skill in the art because it is (1) consistent with the ’711 Patent and the asserted prior art; and (2) it is supported by the testimony of Dr. Singhose. B.” slip op. at 6
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner
“But the Detecting Limitations of claims 1, 19, and 20, merely require that a target be “detected.” The Detecting Limitations do not require that target detection be performed “aboard the reference UAV,” and claim 19 does not recite or require “machine learning.” Moreover, the Specification makes clear that the claims should not be limited to aspects of the disclosed embodiments, as Patent Owner proposes to do here. See, e.g., Ex. 1001, 2:56–59 (“The invention is described in connection with such embodiments, but the invention is not limited to any embodiment. The scope of the invention is limited only by the claims . . . .”) Patent Owner additionally fails to cite any lexicographic definition or clear and unambiguous disclaimer of claim scope sufficient to limit the claims in the manner it proposes. We, thus, are not persuaded that the Detecting Limitations require “applying aboard the reference UAV a machine learning model to the capture image for: (i) identifying a target in the captured image.”” slip op. at 8
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“Priority Date of the Challenged Claims Petitioner contends that claims 1–20 of the ’711 Patent “should not have priority to the October 9, 2016 filing date of U.S. provisional [patent] application 62/405,972 due to a lack of written description support.” Pet. 3. Petitioner thus “assumes” a priority date of October 1, 2017 (the filing date of U.S. Provisional Patent Application No. 62/556,449) for purposes of this proceeding. Id. at n.2; see also Ex. 1003, code (60). Patent Owner does not presently dispute Petitioner’s contention that the ’711 Patent is not entitled to a priority date earlier than October 1, 2017. See generally Prelim. Resp. For purposes of this decision, we accept Petitioner’s undisputed contention that the ’711 Patent is not entitled to a priority date prior to 10 Any determination, no matter how designated in this Institution Decision (except our ultimate decision to institute), is preliminary and non-binding. Our Final Written Decision, based on a fully developed record of arguments and evidence, will state our binding determinations, findings, and conclusions. If a party disagrees with this preliminary construction, or any other determination set forth in this Institution Decision, that party should present its arguments at trial. The parties are reminded that any arguments not made during trial will be considered waived. Patent Owner is further reminded that arguments in the Preliminary Response are not preserved and will be considered waived at trial unless those arguments are re-raised in the Patent Owner Response. The parties are additionally reminded that arguments raised in subsequent briefing must be set forth in full in the briefs themselves, and may not be incorporated by reference from prior filings such as the Preliminary Response. See 37 C.F.R. § 42.6(a)(3). October 1, 2017.11 Accordingly, Petitioner has made a sufficient showing that all of the cited references qualify as prior art. See Pet. 4–6. D.” slip op. at 11
Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 10,514,711 - PTAB · Oct 8, 2025 · IPR2025-00530 · APJ Scott C Moore · IPR · Institution
Instituted review of claims 1–9 on all petition grounds after finding a reasonable likelihood that claim 1 is obvious over Whitmarsh.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“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). If we institute an inter partes review, the trial must encompass all claims and grounds identified in the Petition. 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”). For the reasons set forth below, we conclude that there is a reasonable likelihood that Petitioner will prevail in establishing the unpatentability of at least one of the challenged claims. We, therefore, institute inter partes review of claims 1–9 on the grounds asserted in the Petition. B.” slip op. at 2
- Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)§112(f) appliesDecided for petitioner
“permission module,” as used in claim 1, has “a well understood structural meaning in the computer technology field.” 792 F.3d at 1350. Rather, the limitation in question is “drafted in the same format as a traditional means-plus-function limitation, and merely replaces the term ‘means’ with ‘nonce’ word ‘module,’ thereby connoting a generic ‘black box’ for performing the recited computer-implemented functions.” Id. And, while claim 1 recites the “outputs” of the permission module (i.e., a determination regarding the permissions of an aerial system), “the claim does not describe how the [permission module] interacts with other components in the [discrimination system] in a way that might inform the structural character of the limitation- in-question or otherwise impart structure to the [permission module] as recited in the claim.” Id. at 1351. We also reviewed the Specification, and we agree with Petitioner that the Specification identifies the following structure as corresponding to the claimed permission module: “storage on-board the disruption module 105, storage on-board the identification receiver 102, a remote computing system connected to the disruption module…, or [] any other suitable computing system.” See Pet. 12; Ex. 1001, 9:64–10:4. slip op. at 7
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableInstituted
“from nearby UAVs wireless communications that include information or signatures unique to the UAVs, such as a MAC [media access control] address of the UAV, that is used to identify the transmitting UAV.” Pet. 16– 18 (citing Ex. 1005 ¶¶ 20, 27; Ex. 1006 ¶¶ 8, 10, 13, 15–17; Ex. 1003 ¶¶ 117–118). For example, Petitioner cites Whitmarsh’s teachings that “[a]ll drones have a unique identifier, such as a media access control (MAC) address, that can be determined or read by the DDS [drone defense system] and can be used to identify the drone.” Id. at 16 (quoting Ex. 1006 ¶ 13). Based on these teachings, Petitioner submits that the signal received from the UAVs includes an aerial system identifier signal unique to the aerial system. Id. at 17–18 (citing Ex. 1005 ¶ 27; Ex. 1006 ¶ 13).” slip op. at 10
Claim construction§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 10,249,199 - PTAB · Oct 8, 2025 · IPR2025-00525 · APJ Scott C Moore · IPR · Institution
The Board instituted review of claim 21 on all asserted grounds after finding a reasonable likelihood it is obvious over Beard.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“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). If we institute an inter partes review, the trial must encompass all claims and grounds identified in the Petition. 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”). For the reasons set forth below, we conclude that there is a reasonable likelihood that Petitioner will prevail in establishing the unpatentability of claim 21, the sole challenged claim. We, therefore, institute inter partes review of claim 21 on the grounds asserted in the Petition. B.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“[E]ither (1) a Bachelor of Science in Mechanical Engineering, Electrical Engineering, Aerospace engineering, or an equivalent field, as well as at least 2 years of academic or industry experience in the aerospace, avionics, telecommunications, or electronic device manufacturing industry, or (2) at least four years of industry experience in any of the above industries. Pet. 21 (citing Ex. 1003 ¶ 47). Patent Owner does not presently dispute Petitioner’s proposed formulation. See generally Prelim. Resp. For 3 U.S. Patent App. Pub. No. US 2016/0253907 A1, published Sept. 1, 2016 (Ex. 1010). 4 PCT Pub. No. WO 2016/078093 A1, published May 26, 2016 (Ex. 1011). 5 PCT Pub. No. WO 2016/154949 A1, published Oct. 6, 2016 (Ex. 1012). 6 U.S. Pat. App. Pub. No. US 2016/0127890 A1, published May 5, 2016 (Ex. 1013). 7 PCT Pub. No. WO 2015/043123 A1, published Apr. 2, 2015 (Ex. 1014). purposes of this Decision, we adopt and apply Petitioner’s formulation regarding the level of ordinary skill in the art because it is (1) consistent with the ’959 Patent and the asserted prior art; and (2) it is supported by the testimony of Dr. Chowdhary. B.” slip op. at 5
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“But before describing the embodiments cited by Patent Owner, the Specification plainly states: “Any terms not expressly defined herein have their conventional meaning as commonly understood by those having skill in the relevant art(s).” Ex. 1001, 4:64–67. Thus, the Specification itself cautions against construing the claim terms such as “secure identifier” as limited to the scope of the disclosed embodiments. Here, Patent Owner has not cited any express definition of “secure identifier,” or identified any explicit disclaimer of claim scope that might justify narrowing the scope of this claim term to specific embodiments disclosed in the Specification. In the absence of such a definition or disclaimer, we are not persuaded that the scope of the claim term “secure identifier” should be limited to specific aspects of the preferred embodiments cited by Patent Owner. See Prelim. Resp. 7–14. On this record, and at this stage of the proceeding, we decline to adopt Patent Owner’s proposed construction and preliminarily construe “secure identifier” as “a credential that can be used to securely verify the identity of a device, such as an airborne object or ground-based transmitter.”8” slip op. at 10
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateDecided for petitioner
“’071 Application lack adequate written description support for the “secure identifier” claim limitation. For a patent claim to be entitled to the priority date of an earlier-filed application, the earlier application must provide complete written description support for the claim as required by 35 U.S.C. § 112(a). L.A. Biomedical Rsch. Inst. at Harbor-UCLA Med. Ctr. v. Eli Lilly & Co., 849 F.3d 1049, 1057 (Fed. Cir. 2017) (“L.A. Biomed”). To satisfy this requirement, the written description must “reasonably convey” to a person of ordinary skill in the art that the inventor had possession on the claimed priority date of each limitation of the later-claimed subject matter. L.A. Biomed, 849 F.3d at 1057. It is not enough that an earlier application’s disclosure “renders the later-claimed invention obvious;” as “the disclosure must describe the claimed invention with all its limitations.” L.A. Biomed, 849 F.3d at 1057. On this record, we agree with Petitioner that the ’153 Provisional and ’071 Application lack adequate written description support for the “secure identifier” limitation of claim 21. We have preliminarily construed “secure identifier” as “a credential that can be used to securely verify the identity of a device, such as an airborne object or ground-based transmitter.” See supra § II.B. As discussed above, the Specification of the ’959 Patent does not use the term “secure identifier,” but the Specification contains extensive discussion of the need for an identification credential that is secure (e.g., difficult for a bad actor to clone or impersonate). See, e.g., Ex. 1001, 1:56– 65 (discussing the need for a system that is difficult to “clone”), 10:20–49 (discussing the need “trust” between a drone and ground-based equipment, and the need for a way to verifying the drone’s credentials), 11:5–12:62 (disclosing the use of encryption and a rotating SSID to generate a secure identifier for a drone). None of the portions of the Specification cited above is present in the ’153 Provisional or the ’071 Application. See generally Ex. 1006, 1007. The ’153 Provisional and ’071 Application discuss the need for identifiers for low-altitude aircraft (see, e.g., Ex. 1006, 2; Ex. 1007, 9), but there is no discussion of any need for an identification credential to be secure or resistant to cloning or impersonation. See generally Ex. 1006, 1007. The ’153 Provisional and ’071 Application do not disclose the use of encryption, SSIDs (much less rotating SSIDs), or any other technologies for the purpose of verifying the authenticity of an identification credential. See generally id. Based on our review of the ’153 Provisional and ’071 Application, we preliminarily conclude that neither of these applications would have reasonably conveyed to a person of ordinary skill in the art that the inventor then had possession of the concept of the “secure identifier” that was later claimed in the ’959 Patent.” slip op. at 12
Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · GrahamPatents in suitUS 10,713,959 - Google LLC v. Withrow Networks Inc.InstitutedPTAB · Sep 29, 2025 · IPR2025-00775 · APJ Jason J Chung · IPR · Institution
The Board instituted IPR on claims 1–9 and all asserted grounds, finding a reasonable likelihood that at least one claim is unpatentable, including over Carmel and Mattavelli.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“1. Principles of Law A claim is unpatentable under § 103 if the differences between the claimed subject matter and the prior art are such that the subject matter, as a whole, “would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on the basis of underlying factual determinations, including (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of skill in the art; and (4) when in evidence, objective indicia of obviousness or non-obviousness (i.e., secondary considerations, such as commercial success, long-felt but unsolved need, failure of others, etc.).5 Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 17–18 (1966). We analyze the asserted grounds based on obviousness with the principles we identify above in mind.” slip op. at 9
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Factors pertinent to a determination of the level of ordinary skill in the art include “(1) the educational level of the inventor; (2) type of problems encountered in the art; (3) prior art solutions to those problems; (4) rapidity with which innovations are made; (5) sophistication of the technology; and (6) educational level of active workers in the field.” Envtl. Designs, Ltd. v. Union Oil Co. of Cal., 713 F.2d 693, 696 (Fed. Cir. 1983) (citing Orthopedic Equip. Co. v. All Orthopedic Appliances, Inc., 707 F.2d 1376, 1381–82 (Fed. Cir. 1983)). “Not all such factors may be present in every case, and one or more of these or other factors may predominate in a particular case.” Id. at 696–97. Relying on the testimony of Dr. Polish, Google argues the following: [a] person of ordinary skill in the art . . . would have possessed at least a bachelor’s degree in computer science, computer engineering, electrical engineering, or an equivalent field requiring learning computation principles, and two years of work experience in networking or streaming media systems, particularly audio and video, over the Internet. Additional education could compensate for less practical experience and vice versa.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“In the Petition, Google states that it “does not presently contend that any [claim] term requires express construction.” Pet. 6. In response, Withrow acquiesces; in particular, Withrow argues “the Board need not construe any terms of the ’849 Patent. Petitioner does not contend any [claim] terms require express construction.” Prelim. Resp. 13 (citing Pet. 6). Based on the preliminary record, there is no readily discernible controversy between the parties that requires us to construe any claim terms at this time. See, e.g., Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (noting that “we 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 foundInstituted
“Turning to rationale to combine, Google contends that Carmel and Mattavelli are both directed to processing multimedia data playback “for the appreciation of a user,” while providing the highest perceived audio and video output quality possible in view of system constraints to ensure playback continuity. Pet. 50–51 (citing Ex. 1003, 10:48–54, 11:9–18, 7:35– 49, Figs. 3D, 6B; Ex. 1004, 2309, 2310). Google argues that both Carmel and Mattavelli pertain to compression of multimedia data using well-known coding and compression standards for video streaming. Pet. 51 (citing Ex. 1003, 7:25–26, 11:24–52; Ex. 1004, 2309–2311). Google argues a PHOSITA would appreciate both Carmel and Mattavelli complement each other because Carmel pertains to addressing constraints to available network bandwidth, whereas Mattavalli relates to addressing limits on available processing resources at the client/multimedia player. Pet. 52 (citing Ex. 1003, Abstract, 7:36–41; Ex. 1004, 2309–2312). Google argues that a PHOSITA would have been motivated to combine the complementary teachings in Carmel and Mattavelli to create a more robust streaming system that addresses both bandwidth constraints and client processing limits to provide a best possible playback experience. Pet. 52 (citing Ex. 1002 ¶¶ 212–215). Google argues that Mattavelli teaches merely optimizing transmission bandwidth is not sufficient and is potentially harmful, which provides an express motivation to combine Carmel’s and Mattavelli’s complementary teachings to ensure that different, related links in the streaming playback chain are optimized together. Pet. 53 (citing Ex. 1002 ¶¶ 216–217; Ex. 1004, 2310). In addition, Google argues Carmel contains an express disclosure that would have motivated a PHOSITA to combine Carmel with Mattavelli’s complementary teachings because Carmel states that multimedia playback is achieved “preferably with only a minimal necessary transmission and decoding delay.” Pet. 53–54 (citing Ex. 1002 ¶ 218; Ex. 1003, 10:50–54). Withrow does not specifically respond to these arguments, except for limitations 1[c.ii] and 1[c.iv] discussed infra. See generally Prelim. Resp. Nonetheless, the burden of persuasion remains on Petitioner to demonstrate unpatentability. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). Based on the preliminary record, we discern no deficiency in Google’s characterizations of Carmel, Mattavelli, or the general background knowledge in the art. In addition, for purposes of institution, we are persuaded by Dr. Polish’s testimony concerning the relevant disclosures in Carmel and Mattavelli.” slip op. at 22
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,771,849 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · 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 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,629,187 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · 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 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents 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.