- 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 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · Sep 19, 2025 · IPR2024-00650 · APJ Deborah Katz · IPR · Final written decision
Claims 1–38 are unpatentable: claims 1, 2, 4–7, 11–17, 19–22, and 26–38 are anticipated by the MSR; the remaining claims are obvious over the MSR and cited references.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“Petitioner and Patent Owner characterize one of ordinary skill in the art differently. To Petitioner, the ordinarily skilled artisan would be a medical doctor, or a professional in a related field, with experience treating cancer or access to those with experience in clinical studies of therapeutics and to a pathologist with this experience. (See Pet. 11 (citing Ex. 1003 ¶ 19).) To Patent Owner, the ordinarily skilled artisan would have had a medical or graduate-level degree, or equivalent work experience, in the fields of immunology, genetics, or a related field and would have experience (i) conducting immunology research relating to oncology, (ii) conducting genetics research relating to oncology, or (iii) developing and conducting clinical trials on novel cancer therapies in those fields. (See PO Resp. 5–6 (citing Ex. 2072 ¶¶ 31–32, 91–99).) Petitioner emphasizes medical and treatment aspects in its characterization of an ordinarily skilled artisan, whereas Patent Owner emphasizes research aspects. The ’491 patent claims a method of treating a human patient with cancer having certain characteristics using pembrolizumab and the main prior art reference cited by Petitioner discloses testing pembrolizumab to treat human patients. (See Ex. 1001, 25:36–52, 26:24–41, Ex. 1005; see Decision 8–9.) Accordingly, the relevant field of Patent Owner’s claims is treating human patients, as well as testing existing compounds. In light of the extent of the relevant field, we determine that the level of skill in the art relevant to the claims of the ’491 patent is not limited to knowledge of and experience with conducting research relating to oncology or developing and conducting clinical trials, but includes knowledge of and experience with treating cancer patients with immunotherapy compounds, identifying the conditions these patients may have, and understanding the literature regarding clinical trials for such colorectal cancers and the associated conditions and immunotherapy. C. Claim Construction” slip op. at 8
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“Dr. Lonberg, Patent Owner’s witness, does not dispute any of Dr. Neugut’s or Dr. Oberstein’s testimony, but asserts only that Dr. Neugut’s testimony relies only on what was generally done, not on what is expressly disclosed in the MSR. (See Ex. 2072 ¶¶ 105–107.) On cross-examination, Dr. Lonberg agreed with Dr. Oberstein that patients who had received prior cancer therapy were not excluded from the study described in the MSR. (See Ex. 1245, 57:5–58:2, 40:5–14, 49:2–12.) Thus, after considering the evidence cited by each party, we find Dr. Neugut’s and Dr. Oberstein’s testimony to be the most directly relevant and persuasive about what one of ordinary skill in the art would have understood from the MSR itself. We are also persuaded by the lack of a specific contradiction regarding the understanding of one of ordinarily skill in the art by Dr. Lonberg. Even if some patients who had been previously treated with specific drugs were excluded from the study described in the MSR, we are persuaded that one of ordinary skill in the art would have understood the MSR as including other patients who have been treated with a prior cancer therapy drug. We are persuaded that Petitioner has met its burden of proving whether a skilled artisan would reasonably understand or infer that the limitations of claims 13, 28, 32, and 36 were disclosed in the MSR. Petitioner demonstrates what one of ordinary skill in the art would have understood from the MSR, not what it inherently discloses. (Contra PO Resp. 19–22.)” slip op. at 38
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“Patent Owner argues that the “in response to” limitation of claim 1 describes administering the claimed treatment only to patients determined to have an MSI-H tumor. (See PO Resp. 6.) But neither claim 1 nor claim 16 includes a limitation excluding the treatment of any patient, such as specifically excluding treatment of any patient who has a tumor that is not MSI-H or dMMR. Neither claim 1 nor claim 16 recites any language differentiating between patients or identifying a patient population to be excluded from treatment. Instead, claims 1 and 16 provide that if the colorectal cancer patient is tested and the cancer is determined to be MSI-H or dMMR, the patient is treated with a therapeutically effective amount of pembrolizumab. We note that the methods of claims 1 and 16 use the open-ended transitional phrase “comprising” that is generally interpreted to not exclude additional, unrecited elements. See Invitrogen Corp. v. Biocrest Mfg., L.P., 327 F.3d 1364, 1368 (Fed. Cir. 2003) (“The transition ‘comprising’ in a method claim indicates that the claim is open-ended and allows for additional steps.”); Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501 (Fed. Cir. 1997) (“‘Comprising’ is a term of art used in claim language that means that the named elements are essential, but that other elements may be added and still form a construct within the scope of the claim.”). The use of the open-ended transitional phrase “comprising” in claims 1 and 16 further suggests to us that any additional steps taken in conjunction with expressly recited method steps, such as the treatment of patients who are not MSI-H or dMMR, are not excluded from the scope of the claim.” slip op. at 13
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“discloses species that fall within the scope of claim 1. (See Ex. 2090 ¶ 79; Ex. 1243, 115:5–116:22; Ex. 1085, 673–75; Ex. 1086, 14; Ex. 1003 ¶¶ 25, 67; Ex. 1005, 4.) We are not persuaded that where species falling within the scope of claim 1 were previously known and disclosed in MSR, that claim 1 is patentable over the MSR. See Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381 (Fed. Cir. 2015) (“a reference can anticipate a claim even if it ‘d[oes] not expressly spell out’ all the limitations arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’” the claimed arrangement or combination.” (quoting In re Petering, 301 F.2d 676, 681 (CCPA 1962)). After considering the parties’ arguments and the evidence presented, we are persuaded that the MSR teaches “testing or having tested a biological sample obtained from a patient” having endometrial, small bowel, or gastric cancer and, thus teaches the corresponding limitation of claim 1. d) Element [1.3]: “thereby determining that the patient’s cancer is” slip op. at 26
Patent outcomesUS 11,634,491 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,634,491 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · Sep 18, 2025 · IPR2024-00625 · APJ Deborah Katz · IPR · Final written decision
Claims 1–8 are unpatentable: claims 1–4 and 6–8 are anticipated by MSR, and claim 5 is obvious over MSR with the additional marker-testing teachings of Chapelle.
RulingsFinal written decision- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“In an anticipation analysis, the dispositive question is whether a skilled artisan would ‘reasonably understand or infer’ from a prior art reference that every claim limitation is disclosed in that single reference.” Acoustic Tech., Inc. v. Itron Networked Sols., Inc., 949 F.3d 1366, 1373 (Fed. Cir. 2020). Extrinsic evidence, such as declarations and depositions may be considered when it is used to explain, but not expand, the meaning of a reference. See In re Baxter Travenol Labs., 952 F.2d 388, 390 (Fed. Cir. 1991) (holding that the depositions and declarations of skilled workers were properly used to show what those skilled in the art would have known about the prior art). Although Patent Owner argues that a missing element cannot be filled by what an ordinarily skilled artisan would have envisioned, Petitioner’s argument is based on what one of ordinary skill in the art would have understood from what the MSR expressly teaches. (See Pet. 20 (“Indeed, prior art concerning the MSI-H Study indicates that the physicians understood postings on clinicaltrials.gov indicated that patients had ‘metastatic tumors.’ (EX1049, 444; see also EX1050, S4; EX1003, ¶62.)”).) Unlike the facts of Nidec, where a missing signal could have been envisioned but was not present, we are persuaded by the evidence Petitioner presents that those of ordinary skill in the art understood the MSR express disclosure to include patients with unresectable or metastatic tumors because references referring to the study underlying the MSR discuss the inclusion of patients with metastatic tumors in the study. Even if Dr. Neugut’s reasoning that the reference to “measurable” disease in the MSR would have indicated patients having metastatic cancer is flawed, we are persuaded by Petitioner’s evidence of publications referring to the MSR as a study of metastatic colorectal cancer, and we are further persuaded that one of ordinary skill in the art would have understood the MSR to disclose treating patients having metastatic colorectal cancer with pembrolizumab. (See Ex. 1049, 444, Ex. 1050, S4.) Patent Owner does not address this evidence. Instead, Patent Owner acknowledges that “the MSR discloses treating cancer patients that could be within the claimed subset,” but argues that the MSR does not inherently anticipate results later obtained by treating only patients within the claimed subset. (See Pet. Sur- Reply 5–6.) We are persuaded, though, that Petitioner’s challenge is based on what one of ordinary skill in the art would have understood from the MSR (that patients who had an unresectable or metastatic tumor were selected), not on what is inherent to the disclosure of the MSR. We are persuaded that one of ordinary skill in the art at the time would have understood the MSR to teach selecting a patient “who has an unresectable or metastatic,” as required in claim 1. c) Element 1.2: “microsatellite instability-high (MSI-H) or mismatch slip op. at 14
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“Patent Owner argues further that the MSR discloses an experimental use that does not qualify as prior art. (See PO Resp. 16–23.) Patent Owner argues that an inventor can be granted latitude to experiment in the public eye until her invention is ready for patenting. (See id. at 16 (citing Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 64 (1998).) According to Patent Owner, the experimental use negation applies to the MSR under a 13-factor analysis provided in Allen Eng'g Corp. v. Bartell Indus., Inc., 299 F.3d 1336, 1353 (Fed. Cir. 2002). (See PO Resp. 17–23.) For example, Patent Owner argues that to establish that treatment of MSI-H cancers was effective, the inventors had to test treatment in humans, there being no animal models, and had to publish the MSR on the government website under federal law. (See PO Resp. 18–20.) Patent Owner argues further that the inventors had control over the MSI-H clinical study and that the field of cancer treatment was highly unpredictable, among other facts. (See id. at 19–20.) Patent Owner argues that “[a]t the time of the MSR’s posting, the claimed invention was not, nor could it have been, ready for patenting. The clinical study that ultimately collected the data reported in the patent specification and supporting the patent claims had not and could not have commenced before the MSR was posted.” (Id. at 21.) In City of Elizabeth, the Supreme Court was concerned that “[i]t is sometimes said that an inventor acquires an undue advantage over the public by delaying to take out a patent, inasmuch as he thereby preserves the monopoly to himself for a longer period than is allowed by the policy of the law,” but held that “when the delay is occasioned by a bona fide effort to bring his invention to perfection, or to ascertain whether it will answer the purpose intended,” the experiment use exception can preserve the inventor’s rights. City of Elizabeth v. Am. Nicholson Pavement Co., 97 U.S. 126, 137 (1877). Because we are not persuaded that Patent Owner could not have filed an earlier application, we are not persuaded that the experimental use doctrine is properly applied in this case. Given that clinical trial protocols published on the ClinicalTrials.gov website have been successfully asserted as prior art in other cases, we are not persuaded by Patent Owner’s arguments that the MSR is not available as prior art against the challenged claims. See, e.g., Salix Pharms., Ltd. v. Norwich Pharms. Inc., 98 F.4th 1056, 1061 (Fed. Cir.), cert. denied, 145 S. Ct. 567 (2024), and cert. denied, 145 S. Ct. 983 (2024). After considering the parties’ arguments and evidence, we are” slip op. at 24
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“In order to show that objective evidence renders the method of claim 5 non-obvious, Patent Owner must show a nexus between the subject matter recited in claim 5 and the evidence of non-obviousness. See Henny Penny Corp. v. Frymaster LLC, 938 F.3d 1324, 1332 (Fed. Cir. 2019) (“to be accorded substantial weight in the obviousness analysis, the evidence of secondary considerations must have a ‘nexus’ to the claims, i.e., there must be ‘a legally and factually sufficient connection’ between the evidence and the patented invention. . . . Ultimately, ‘[t]he patentee bears the burden of showing that a nexus exists.’” (quoting Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387, 1392 (Fed. Cir. 1988), WMS Gaming, Inc. v. Int'l Game Tech., 184 F.3d 1339, 1359 (Fed. Cir. 1999)). Patent Owner argues that there is a nexus between the development and commercialization of pembrolizumab and the patented method of treatment recited in the challenged claims, citing, inter alia, the package insert for Keytruda® (pembrolizumab), but Patent Owner does not direct us to evidence of a nexus to MSI-H or MMR deficient tumors that exhibit instability in the microsatellite markers recited in claim 5 and the unexpected results, commercial success, or other objective measures of non-obviousness flowing from these additional limitations. (See PO Resp. 50–63 (citing Ex. 2129, Ex. 2072 ¶ 190, Ex. 2090 ¶¶ 82–92).) Patent Owner directs us only to evidence regarding determining MSI-H status and then using Keytruda® to treat MSI-H cancer patients, which we determine to be anticipated by the MSR. (See PO Resp. 60.) When evidence of a “secondary consideration [] is exclusively related” slip op. at 34
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“(Ex. 1001, 26:19–28.) In Grounds 3 and 5, Petitioner argues, relying on Dr. Neugut’s testimony, that Chapelle teaches standard methods of testing whether a tumor is MSI-H, including determining whether the patient’s tumor exhibits instability in a microsatellite marker, such as BAT-25 or BAT-26. (See Pet. 42 (citing Ex. 1007, 3380, 3383; Ex. 1003 ¶ 107).) For example, Chapelle states that “‘a standard test’ using a ‘[p]anel consisting of … BAT26, BAT25’ has ‘stood the test of time.’” (Ex. 1007 at 3382.) Dr. Neugut testifies that one of ordinary skill in the art would have been motivated to treat a patient with an unresectable or metastatic MSI-H dMMR tumor, wherein the tumor exhibits instability in the BAT-25 and BAT-26 microsatellite marker, and would have expected success in doing so, in light of the teachings of Chapelle. (See Ex. 1003 ¶¶ 105–108.) We find that the record as recounted above supports Petitioner’s challenges of claim 5 in Grounds 3 and 5.” slip op. at 31
Patent outcomesUS 11,339,219 unpatentable§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,339,219 - Synaffix B.V. v. Hangzhou Dac Biotech Co., Ltd.Some claims unpatentablePTAB · Aug 26, 2025 · IPR2022-01531 · APJ Devon Zastrow Newman · IPR · Final written decision
Claims 1–17, 20, 21, 24, 26, and 29–31 are unpatentable; claims 25 and 32–34 were not shown unpatentable, and the motion to exclude was dismissed as moot.
RulingsFinal written decision- RemandOther
“review of claims 1–17, 20, 21, 24–26, and 29–34 of the ’682 patent. Paper 2 (“Pet.”), 1, 3. Patent Owner, Hangzhou DAC Biotech Co., Ltd., filed a Preliminary Response (Paper 9, “Prelim. Resp.”). We initially determined that the information presented in the Petition did not establish a reasonable likelihood that Petitioner would prevail with respect to at least one of the challenged claims, and did not institute inter partes review. Paper 17. Petitioner requested Director review of our decision denying institution (Paper 18 (“Request”)). The Director delegated review of the decision to a Delegated Rehearing Panel (“DRP”). Paper 19. Patent Owner was granted the option to file a response to Petitioner’s Request (Paper 22 (“Request Resp.”)). The Delegated Review Panel vacated our decision and remanded the case to this panel with a revised claim construction for claim 1. Paper 23 (“DRP Dec.”). On August 30, 2024, we instituted an inter partes review after remand from the Director. Paper 25 (“Inst. Dec.”). Patent Owner subsequently filed a Patent Owner Response (Paper 31, “Resp.”), Petitioner filed a Reply (Paper 36, “Reply”), Patent Owner filed a Sur-reply (Paper 44, “Sur-reply”), and Petitioner filed a Sur-sur-reply (Paper 48, “Sur-sur-reply”).” slip op. at 2
- PTAB / AIA Trials › Motions to amend / substitute claimsOther
“I. Patent Owner’s Motion to Exclude Evidence Patent Owner moves to exclude Exhibits 1089 and 1090. Paper 50. As we did not rely on either of Exhibits 1089 or 1090 in deciding this matter, Patent Owner’s motion is dismissed as moot.” slip op. at 96
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableMixed
“For these reasons, Patent Owner’s arguments and cited evidence also” slip op. at 31
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableNot shown unpatentableMixed
“function as R2, and the ethyl group may function as R4, which can be a linear alkyl having 1–6 carbon atoms. We note that claim 3 permits R5 and R6 to be absent. For these reasons, the arguments presented in the Petition demonstrate that claim 3 would have been obvious over Singh’s Compound 3 when modified in view of Harris.” slip op. at 73
Patent outcomesUS 10,131,682 mixed§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,131,682 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · Jun 9, 2025 · IPR2024-00240 · APJ Deborah Katz · IPR · Final written decision
Claims 1–42 are unpatentable: claims 1–42 are anticipated by the MSR, and the Board also finds the challenged claims obvious over the MSR and cited combinations.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“claims a method of treating a human patient with colorectal cancer having certain characteristics using pembrolizumab and the main prior art reference cited by Petitioner discloses testing pembrolizumab to treat human patients. (See Ex. 1001, 25:40–50, Ex. 1005; see Decision 8–9.) Accordingly, the relevant field of Patent Owner’s claims is treating human patients, as well as testing existing compounds. Neither party directs us to evidence of the level of skill in the art beyond what we considered for institution of trial. In the Decision to institute trial, we determined that the level of skill in the art relevant to the claims of the ’393 patent is not limited to knowledge of and experience with conducting research relating to oncology or developing and conducting clinical trials. (See Dec. 8–9.) We determined that the level of skill also includes knowledge of and experience with treating colorectal cancer patients with immunotherapy compounds, identifying the conditions these patients may have, and understanding the literature regarding clinical trials for such colorectal cancers and the associated conditions and immunotherapy. (See id.) Because the parties do not present additional evidence or argument, we maintain that determination.” slip op. at 9
- Expert testimonyPetitioner expert creditedDecided for petitioner
“what one of ordinary skill in the art would have known and understood at the relevant time. Specifically, Petitioner relies on the testimony of Alfred L. Neugut, M.D., Ph.D., M.P.H.3 (Ex. 1003) and Paul E. Oberstein, M.D. (Ex. 1150). Patent Owner relies on the testimony of Nils Lonberg, Ph.D. (Ex. 2001) and Richard Goldberg, M.D. (Ex. 2090).” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“1 requires a causal relationship wherein the patient must be tested for MSI-H and, if he or she is determined to be MSI-H or dMMR, then the patient is treated with 10 mg/kg of pembrolizumab every 14 days. We further agree that this relationship is different than the use of the term “after” in claims 7, 20, and 27, wherein patients must be treated with a different cancer therapy, and wherein the cancer must have later progressed for the treatment to be within the scope of these claims. (Ex. 1001, 25:66–7, 26:44–46, 26:63–64.) In claim 1, a biological sample from the patient must be tested to determine if the cancer is MSI-H and, if so, the patient is treated with a therapeutically effective amount of pembrolizumab. For this reason, if the prior art teaches the limitations of 1) testing a biological sample obtained from a patient having colorectal cancer to determine that the patient’s colorectal cancer is microsatellite instability high or mismatch repair deficient, and 2) treating the patient with a therapeutically effective amount of pembrolizumab if the patient’s colorectal cancer is determined to be microsatellite instability high or DNA mismatch repair deficient, the art anticipates claim 1. We are not persuaded that claim 1 requires or excludes anything else because nothing else is recited in the claim.” slip op. at 12
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“Microsatellite Unstable (MSI) Tumors.” (Ex. 1005, 2.) The parties’ witnesses agree that MK-3475 is pembrolizumab, the compound recited in claim 1. (See Neugut Decl., Ex. 1003 ¶ 37; see Lonberg Decl., Ex. 2001, ¶ 65.) Patent Owner does not dispute Petitioner’s assertion that the MSR was published on a government web site on June 10, 2013, more than two years before the priority date of the ’393 patent on July 10, 2015. (See Pet. 7 (citing Ex. 1005, 3, Ex. 1003 ¶ 35).)” slip op. at 17
Patent outcomesUS 11,591,393 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,591,393 - PTAB · May 21, 2025 · IPR2025-00193 · APJ Sheridan K Snedden · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1, 3, 6, 10, 11, 16, 18, 21, 24–26, or 30 were unpatentable on any asserted ground.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“To institute an inter partes review, we must determine that the information presented in the Petition shows “a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). After considering the evidence and arguments presented in the Petition, we determine that Petitioner has not demonstrated a reasonable likelihood of success in proving that at least 1 claim of the ’030 patent is unpatentable.” slip op. at 2
- BurdenNot shown unpatentable
“What is missing from Petitioner’s stated motivation for modifying the array of Cantor is a reason why a POSA would seek to correlate the identification sequence with a location on the array at all. Prelim. Resp. 72. Indeed, the location of a bead on the substrate is not pertinent to the analysis disclosed in Cantor. Ex. 2002 ¶ 172; see also id. at ¶ 31 (Cantor “does not relate to the [spatial] analysis of tissue samples . . . .”). “[O]bviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed invention.” Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015). Here, Cantor fails to teach or suggest capture probes distributed randomly on a substrate comprising a nucleic acid sequence that identifies a unique location on the substrate as required by the challenged claims, and Petitioner fails to adequately articulate why a person of ordinary skill in the art would have modified Cantor to make the recited capture probes. In view of the above, we find that, on this record, Petitioner has failed to establish that Cantor teaches or suggests each element of the challenged claims. Accordingly, we determine that Petitioner has not demonstrated a reasonable likelihood of prevailing on its challenge that any of claims 1, 3, 6, 10, 11, 16, 18, 21, 24–26, and 30 would have been obvious over Cantor.” slip op. at 20
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner does not argue that any claim term requires construction. Pet. 22–23. Likewise, Patent Owner takes the position that “no claim terms 2 Person of ordinary skill in the art. require explicit construction” for purposes of determining whether to institute inter partes review. Prelim. Resp. 19. Having considered the parties’ positions and evidence of record, we determine that no express construction of any claim term is necessary to determine whether to institute inter partes review. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 8
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“What is missing from Petitioner’s stated motivation for modifying the array of Cantor is a reason why a POSA would seek to correlate the identification sequence with a location on the array at all. Prelim. Resp. 72. Indeed, the location of a bead on the substrate is not pertinent to the analysis disclosed in Cantor. Ex. 2002 ¶ 172; see also id. at ¶ 31 (Cantor “does not relate to the [spatial] analysis of tissue samples . . . .”). “[O]bviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed invention.” Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015). Here, Cantor fails to teach or suggest capture probes distributed randomly on a substrate comprising a nucleic acid sequence that identifies a unique location on the substrate as required by the challenged claims, and Petitioner fails to adequately articulate why a person of ordinary skill in the art would have modified Cantor to make the recited capture probes. In view of the above, we find that, on this record, Petitioner has failed to establish that Cantor teaches or suggests each element of the challenged claims. Accordingly, we determine that Petitioner has not demonstrated a reasonable likelihood of prevailing on its challenge that any of claims 1, 3, 6, 10, 11, 16, 18, 21, 24–26, and 30 would have been obvious over Cantor.” slip op. at 20
Claim construction§ 102 anticipation§ 103 obviousnessPatents in suitUS 11,761,030 - PTAB · May 21, 2025 · IPR2025-00192 · APJ Sheridan K Snedden · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1, 5, 17, 20, 23, 28, or 29 were unpatentable over the asserted grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“To institute an inter partes review, we must determine that the information presented in the Petition shows “a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). After considering the evidence and arguments presented in the Petition, we determine that Petitioner has not demonstrated a reasonable likelihood of success in proving that at least 1 claim of the ’138 patent is unpatentable.” slip op. at 2
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentableNot shown unpatentable
“[O]bviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed invention.” Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015). Here, Cantor fails to teach or suggest capture probes distributed randomly on a substrate comprising a nucleic acid sequence that identifies a unique location on the substrate as required by the challenged claims, and Petitioner fails to adequately articulate why a person of ordinary skill in the art would have modified Cantor to make the recited capture probes. In view of the above, we find that, on this record, Petitioner has failed to establish that Cantor teaches or suggests each element of the challenged claims. Accordingly, we determine that Petitioner has not demonstrated a reasonable likelihood of prevailing on its challenge that any of claims 1, 5, 17, 20, 23, 28, and 29 would have been obvious over Cantor. slip op. at 21
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedDecided for patent owner
“3. Discussion Petitioner challenges whether certain elements of independent claims 1 and 17 are supported by the ’124 provisional and/or whether the ’138 patent’s priority chain is intact. Pet. 52–60. Having considered the parties’ positions and evidence of record, however, we agree with Patent Owner’s written description analysis, summarized above, and find (1) that the ’124 Provisional provides adequate written description support for each of the challenged claim elements; (2) that the ’138 patent’s priority chain is intact; and (3) that the ’138 patent is therefore entitled to the priority date of April 5, 2010. Consequently, Frisen is not prior art to the challenged claims.” slip op. at 28
- Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artDecided for patent owner
“3. Discussion Petitioner challenges whether certain elements of independent claims 1 and 17 are supported by the ’124 provisional and/or whether the ’138 patent’s priority chain is intact. Pet. 52–60. Having considered the parties’ positions and evidence of record, however, we agree with Patent Owner’s written description analysis, summarized above, and find (1) that the ’124 Provisional provides adequate written description support for each of the challenged claim elements; (2) that the ’138 patent’s priority chain is intact; and (3) that the ’138 patent is therefore entitled to the priority date of April 5, 2010. Consequently, Frisen is not prior art to the challenged claims.” slip op. at 28
Claim construction§ 102 anticipation§ 103 obviousnessPatents in suitUS 11,549,138 - Apple Inc. v. Geoscope Technologies Pte. Ltd.All claims unpatentablePTAB · May 7, 2025 · IPR2024-00031 · APJ Annette R Reimers · IPR · Final written decision
Claims 16–20, 24, 26, and 27 are unpatentable: claims 16, 19, 20, 24, and 27 are anticipated by Bhattacharya, and all challenged claims are obvious over Bhattacharya and Spain.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“We agree with Patent Owner for the following reasons. First, Patent Owner’s definition is consistent with our determination in IPR2023-01210, which involved the same ’358 patent, and Petitioner does not explain sufficiently why we should adopt a different definition. See generally Pet. Reply.” slip op. at 8
- Expert testimonyPetitioner expert creditedDecided for petitioner
“Sundaresan Declaration, Dr. Sundaresan implied agreement with the POSITA definition based on its inclusion in a signed declaration.” Pet. Reply 15. We agree with Petitioner. Although Dr. Sundaresan does not state explicitly that the proposed definition of the ordinary skill in the art is his opinion, we are persuaded that the manner in which the definition is set forth in his declaration indicates that he agrees with the definition. In this case, Patent Owner attempts to make much of Dr. Sundaresan’s statement that he had been informed of the qualifications of a person of ordinary skill in the art. See PO Resp. 42–44. Dr. Sundaresan’s testimony, however, set forth this understanding of the requisite level of skill in the art (Ex. 1003 ¶ 8). In his supplemental declaration, Dr. Sundaresan further testifies that: I agreed with this POSITA definition when preparing the Declaration, and I continue to hold the opinion that the POSITA definition is both correct and appropriate based on the disclosures of the ’358 patent and the prior art analyzed in the Declaration. Ex. 1055 ¶ 17. Dr. Sundaresan further testifies that “[i]f I did not agree with the POSITA definition, then it would not have been included [] in paragraph 8 of the Declaration.” Id. ¶ 18. Dr. Sundaresan’s inclusion of the definition of the level of ordinary skill in his original declaration indicates that he” slip op. at 13
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“explained below, we agree with Petitioner that Patent Owner’s additional requirement of evaluating the calibration data to determine the boundaries of the area represented by a grid point should not be included in the construction of either “grid point” or “non-uniform grid point.” Instead, based on the full record, we discern no reason to alter our prior construction of “grid point” as “a point associated with representative calibration data for an area” and maintain that construction for this Final Written Decision. The construction of “grid point” we adopt is supported by the Specification of the ’358 patent. Namely, the ’358 patent discloses that “[i]n general, a non-uniform grid point (NUG) may represent the signal characteristics and/or calibration data over a given region,” and “NUGs district court identified the second quoted passage, which is identically recited in the ’104 patent (see Ex. 2018, 3:50–60) as “provid[ing] a clear indication of the meaning of ‘grid point.’” Ex. 2012, 19 (emphasis added). We agree with the district court’s analysis. Although the ’358 patent does not explain how a generic “grid point” might differ from the described “nonuniform grid point,” we do not find this distinction pertinent to construing “grid point” in this case because neither party raises this issue. Also, based on the claim wording “non-uniform grid point,” a “non-uniform grid point” is a type of grid point. See Pet. Reply 4 (explaining why that plain meaning supports Petitioner’s proposed construction). Furthermore, the district court construed “grid point” only, not “non-uniform grid point.” Ex. 2012, 18–20.” slip op. at 26
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“Based on the entire trial record, we agree with Petitioner’s analysis with supporting evidence and credit Dr. Sundaresan’s testimony supporting Petitioner’s position. See Pet. 20–37. Thus, we determine that Bhattacharya discloses the recitations of claim 15. b. Remaining Claims 16, 19, 20, 24, and 27 Claims 16, 19, 20, 24, and 27 depend from claim 15. Ex. 1001, 13:19–21, 12:30–36, 12:52–55; 12:63–67. Petitioner accounts for the limitations recited in each of claims 16, 19, 20, 24, and 27. Pet. 37–42. Patent Owner does not offer any arguments specifically addressing the limitations of claims 16, 19, 20, 24, and 27. See PO Resp. passim. Petitioner shows, by a preponderance of the evidence, that each element of claims 16, 19, 20, 24, and 27 is disclosed by Bhattacharya.” slip op. at 41
Patent outcomesUS 8,400,358 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,400,358 - Apple Inc. v. Geoscope Technologies Pte. Ltd.All claims unpatentablePTAB · May 7, 2025 · IPR2024-00032 · APJ Brian D Range · IPR · Final written decision
Claims 2–5, 9, 11, 12, 14–16, 18–22, 27, 29, 31, and 32 are unpatentable over the asserted anticipation and obviousness grounds; claims 1, 25, and 35 were disclaimed.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“The ’494 patent is directed to locating a wireless mobile device in a geographic region. Ex. 1001, 1:20–27; PO Resp. 45. Bhattacharya is directed to estimating the geographic location of a wireless terminal. Ex. 1005, code (57), ¶¶ 1, 13; PO Resp. 44–45. Spain is directed to a method for locating the concentration of mobile radio traffic in a coverage area. Ex. 1006, code (54), ¶¶ 1, 11; PO Resp. 45. We find that there is support in the ’494 patent and prior art consistent with Patent Owner’s assertion that the qualifications of a person of skill would include knowledge of radio navigation and mobile communications technology. Accordingly, we adopt Patent Owner’s proposed qualifications for a person of ordinary skill.” slip op. at 9
- BurdenDecided for petitioner
“Patent Owner, however, has not identified any language in the Petition that explicitly incorporates by reference Dr. Sundaresan’s testimony. See generally PO Resp.; PO Sur-Reply. Nevertheless, to the extent that the Petition purportedly incorporates by reference Dr. Sundaresan’s testimony, we do not find such incorporation sufficiently extensive to merit disregarding the testimony. Typically, an incorporation by reference is deemed improper in instances in which large portions of a declaration are incorporated—particularly where the incorporation serves to circumvent a word-count limit. See, e.g., Cisco Systems, Inc. v. C-Cation Techs., LLC, IPR2014-00454, Paper 12 at 10 (PTAB Aug. 29, 2014) (informative). In this case, however, Dr. Sundaresan’s testimony describing the level of ordinary skill in the art is short. Ex. 1003 ¶ 8. The amount of testimony is not extensive and, thus, its purported incorporation into the Petition presents little or no imposition on Patent Owner or the Board.” slip op. at 12
- Expert testimonyPetitioner expert creditedDecided for petitioner
“In reply, Petitioner argues that “under any reasonable read of the Sundaresan Declaration, Dr. Sundaresan implied agreement with the POSITA definition based on its inclusion in a signed declaration.” Pet. Reply 15. We agree with Petitioner. Although Dr. Sundaresan does not state explicitly that the proposed definition of the ordinary skill in the art is his opinion, we are persuaded that the manner in which the definition is set forth in his declaration indicates that he agrees with the definition. Patent Owner attempts to make much of Dr. Sundaresan’s statement that he had been informed of the qualifications of a person of ordinary skill in the art. See PO Resp. 41–43. Dr. Sundaresan’s testimony, however, set forth this understanding of the requisite level of skill in the art (Ex. 1003 9 Dr. Sundaresan has a doctoral degree in electrical and computer engineering and has extensive experience in wireless communications. Ex. 1003 ¶¶ 75–78. Dr. Sundaresan also has experience with navigation and geolocation systems such as development of wireless tracking systems, as evidenced by his experience in companies such as NavigateIO Inc. Id. at ¶¶ 77–78. Patent Owner does not argue that Dr. Sundaresan fails to meet requirements for the level of qualifications of one of ordinary skill in the art under its proposed qualifications, which we adopt here. See generally PO Resp.; PO Sur-reply. Based on a review of his qualifications, we determine that Dr. Sundaresan qualifies as a person of ordinary skill at the time of the invention. ¶ 8). In his supplemental declaration, Dr. Sundaresan testifies: I agreed with this POSITA definition when preparing the Declaration, and I continue to hold the opinion that the POSITA definition is both correct and appropriate based on the disclosures of the ’358 patent and the prior art analyzed in the Declaration. Ex. 1055 ¶ 17. Dr. Sundaresan further testifies that “[i]f I did not agree with the POSITA definition, then it would not have been included [] in paragraph 8 of the Declaration.” Id. ¶ 18. Dr. Sundaresan’s inclusion of the definition of the level of ordinary skill in his original declaration indicates that he agrees with the definition, as confirmed by his cited subsequent testimony. We note that, even with Patent Owner’s arguments, the record is clear that Patent Owner was on notice of Petitioner’s proposed definition of the level of ordinary skill at the time of the Petition. Pet. 6; cf. Corephotonics, Ltd. v. Apple Inc., 84 F.4th 990, 1006 (Fed. Cir. 2023) (holding that Petitioner is not required to anticipate all arguments in its Petition and allowing consideration of reply where patent owner had sufficient notice of petitioner’s position and adequate opportunity to respond).” slip op. at 13
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“explained below, we agree with Petitioner that Patent Owner’s additional requirement of evaluating the calibration data to determine the boundaries of the area represented by a grid point should not be included in the construction of either “grid point” or “non-uniform grid point.” Instead, based on the full record, we discern no reason to alter our prior construction of “grid point” as “a point associated with representative calibration data for an area” and maintain that construction for this Final Written Decision.” slip op. at 27
Patent outcomesUS 8,786,494 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,786,494
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.