- 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 - Samsung Electronics Co. Ltd. / Samsung Electronics America, Inc. v. VB Assets, LLCInstitution deniedPTAB · Sep 12, 2025 · IPR2025-00869 · APJ Kalyan K Deshpande · IPR · Director review
The Director granted Patent Owner’s discretionary-denial requests and denied institution under § 314(a), citing settled expectations and prior adjudications.
RulingsDirector review decision- Settled expectationsInstitution denied settled expectationsDenied
“Other considerations, however, weigh in favor of discretionary denial. In particular, each of the challenged patents has been in force for more than ten years, creating strong settled expectations for Patent Owner. Additionally, the patents challenged in IPR2025-00866, IPR2025-00867,” slip op. at 2
- Other 314aInstitution denied discretionary otherDenied
“and IPR2025-00869 have all been subject to previous adjudications. The patents challenged in IPR2025-00866, IPR2025-00867, and IPR2025-00869 were involved in prior Board proceedings. In those proceedings, the Board denied institution of two petitions and entered a final written decision finding the challenged claims not unpatentable in the third proceeding. DD Req. 12; see also IPR2025-00867, Paper 8, 11–12; IPR2025-00869, Paper 8, 12. The patents challenged in IPR2025-00866 and IPR2025-00867 were also subject to a prior district court proceeding, in which the patents were found not invalid. DD Req. 12; IPR2025-00867, Paper 8, 12. It is not an efficient use of Board resources to further consider petitions challenging patents that have already been subject to challenges before the Office or patents that already have had validity adjudicated either at the Board or in another tribunal. Although certain arguments are highlighted above, the determination to exercise discretion to deny institution is based on a holistic assessment of all of the evidence and arguments presented. Accordingly, the Petitions are denied under 35 U.S.C. § 314(a).” slip op. at 3
Discretionary denialPatents in suitUS 8,886,536 - Samsung Electronics Co. Ltd. / Samsung Electronics America, Inc. v. VB Assets, LLCInstitution deniedPTAB · Sep 12, 2025 · IPR2025-00868 · APJ Kalyan K Deshpande · IPR · Director review
The Director granted Patent Owner’s discretionary-denial requests and denied the petitions under § 314(a), instituting no trial based on the holistic assessment of the record.
RulingsDirector review decision- Settled expectationsDecided for patent owner
“Other considerations, however, weigh in favor of discretionary denial. In particular, each of the challenged patents has been in force for more than ten years, creating strong settled expectations for Patent Owner. Additionally, the patents challenged in IPR2025-00866, IPR2025-00867,” slip op. at 2
- Other 314aInstitution denied settled expectationsInstitution denied discretionary otherInstitution denied
“Although certain arguments are highlighted above, the determination to exercise discretion to deny institution is based on a holistic assessment of all of the evidence and arguments presented. Accordingly, the Petitions are denied under 35 U.S.C. § 314(a). In consideration of the foregoing, it is: ORDERED that Patent Owner’s requests for discretionary denial are granted; and FURTHER ORDERED that the Petitions are denied, and no trial is instituted.” slip op. at 3
Discretionary denialPatents in suitUS 8,515,765 - Samsung Electronics Co. Ltd. / Samsung Electronics America, Inc. v. VB Assets, LLCInstitution deniedPTAB · Sep 12, 2025 · IPR2025-00867 · APJ Kalyan K Deshpande · IPR · Director review
The Director denied institution under § 314(a), citing settled expectations and prior adjudications of the challenged patents.
RulingsDirector review decision- Settled expectationsInstitution denied settled expectationsDecided for patent owner
“Other considerations, however, weigh in favor of discretionary denial. In particular, each of the challenged patents has been in force for more than ten years, creating strong settled expectations for Patent Owner. Additionally, the patents challenged in IPR2025-00866, IPR2025-00867,” slip op. at 2
- Other 314aInstitution denied discretionary otherInstitution denied
“and IPR2025-00869 have all been subject to previous adjudications. The patents challenged in IPR2025-00866, IPR2025-00867, and IPR2025-00869 were involved in prior Board proceedings. In those proceedings, the Board denied institution of two petitions and entered a final written decision finding the challenged claims not unpatentable in the third proceeding. DD Req. 12; see also IPR2025-00867, Paper 8, 11–12; IPR2025-00869, Paper 8, 12. The patents challenged in IPR2025-00866 and IPR2025-00867 were also subject to a prior district court proceeding, in which the patents were found not invalid. DD Req. 12; IPR2025-00867, Paper 8, 12. It is not an efficient use of Board resources to further consider petitions challenging patents that have already been subject to challenges before the Office or patents that already have had validity adjudicated either at the Board or in another tribunal. Although certain arguments are highlighted above, the determination to exercise discretion to deny institution is based on a holistic assessment of all of the evidence and arguments presented. Accordingly, the Petitions are denied under 35 U.S.C. § 314(a).” slip op. at 3
Discretionary denialPatents in suitUS 7,818,176 - Samsung Electronics Co. Ltd. / Samsung Electronics America, Inc. v. VB Assets, LLCInstitution deniedPTAB · Sep 12, 2025 · IPR2025-00866 · APJ Kalyan K Deshpande · IPR · Director review
The Director granted Patent Owner’s discretionary-denial requests and denied institution of IPR for the challenged patent under § 314(a).
RulingsDirector review decision- Settled expectationsInstitution denied settled expectationsDenied
“Other considerations, however, weigh in favor of discretionary denial. In particular, each of the challenged patents has been in force for more than ten years, creating strong settled expectations for Patent Owner. Additionally, the patents challenged in IPR2025-00866, IPR2025-00867,” slip op. at 2
- Other 314aInstitution denied discretionary otherDenied
“and IPR2025-00869 have all been subject to previous adjudications. The patents challenged in IPR2025-00866, IPR2025-00867, and IPR2025-00869 were involved in prior Board proceedings. In those proceedings, the Board denied institution of two petitions and entered a final written decision finding the challenged claims not unpatentable in the third proceeding. DD Req. 12; see also IPR2025-00867, Paper 8, 11–12; IPR2025-00869, Paper 8, 12. The patents challenged in IPR2025-00866 and IPR2025-00867 were also subject to a prior district court proceeding, in which the patents were found not invalid. DD Req. 12; IPR2025-00867, Paper 8, 12. It is not an efficient use of Board resources to further consider petitions challenging patents that have already been subject to challenges before the Office or patents that already have had validity adjudicated either at the Board or in another tribunal. Although certain arguments are highlighted above, the determination to exercise discretion to deny institution is based on a holistic assessment of all of the evidence and arguments presented. Accordingly, the Petitions are denied under 35 U.S.C. § 314(a).” slip op. at 3
Discretionary denialPatents in suitUS 8,073,681 - 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 - Samsung Electronics Co., Ltd. / Samsung Electronics America, Inc. v. Genghiscomm Holdings LLCInstitution deniedPTAB · Aug 22, 2025 · IPR2025-00793 · APJ Kalyan K Deshpande · IPR · Director review
The Director granted Patent Owner’s request for discretionary denial and denied the petitions, declining to institute IPR based on a holistic assessment under § 314(a).
RulingsDirector review decision- Other 314aInstitution denied discretionary otherInstitution denied
“After considering the parties’ arguments and the record, and in view of all relevant considerations, discretionary denial of institution is appropriate in these proceedings. This determination is based on the totality of the evidence and arguments the parties have presented. This case presents essentially the same discretionary considerations at those presented in IPR2025-00780 and IPR2025-00781. See, e.g., Samsung Electronics Co. v. GhengisComm Holdings LLC, IPR2025-00780, Paper 11 (Director August 14, 2025) (granting Patent Owner’s request for discretionary denial). Accordingly, that analysis is incorporated here. Id. at 2–3. Although the patents challenged in these proceedings have not been in force for as long as those in IPR2025-00780 and IPR2025-00781, this fact alone does not tip the balance against discretionary denial. The determination to exercise discretion to deny institution is based on a holistic assessment of all of the evidence and arguments presented. Accordingly, the Petition is denied under 35 U.S.C. § 314(a).” slip op. at 2
Discretionary denialPatents in suitUS 11,424,792 - Samsung Electronics Co., Ltd. / Samsung Electronics America, Inc. v. Genghiscomm Holdings LLCInstitution deniedPTAB · Aug 22, 2025 · IPR2025-00792 · APJ Kalyan K Deshpande · IPR · Director review
The Director granted Patent Owner’s request for discretionary denial and denied the petitions, so no IPR trial was instituted.
RulingsDirector review decision- Other 314aInstitution denied discretionary otherInstitution denied
“of all relevant considerations, discretionary denial of institution is appropriate in these proceedings. This determination is based on the totality of the evidence and arguments the parties have presented. This case presents essentially the same discretionary considerations at those presented in IPR2025-00780 and IPR2025-00781. See, e.g., Samsung Electronics Co. v. GhengisComm Holdings LLC, IPR2025-00780, Paper 11 (Director August 14, 2025) (granting Patent Owner’s request for discretionary denial). Accordingly, that analysis is incorporated here. Id. at 2–3. Although the patents challenged in these proceedings have not been in force for as long as those in IPR2025-00780 and IPR2025-00781, this fact alone does not tip the balance against discretionary denial. The determination to exercise discretion to deny institution is based on a holistic assessment of all of the evidence and arguments presented. Accordingly, the Petition is denied under 35 U.S.C. § 314(a).” slip op. at 2
Discretionary denialPatents in suitUS 11,381,285 - Samsung Electronics Co., Ltd. / Samsung Electronics America, Inc. v. Genghiscomm Holdings LLCInstitution deniedPTAB · Aug 22, 2025 · IPR2025-00791 · APJ Kalyan K Deshpande · IPR · Director review
The Director granted Patent Owner’s discretionary-denial request and denied institution of inter partes review under § 314(a).
RulingsDirector review decision- Other 314aInstitution denied discretionary otherInstitution denied
“of all relevant considerations, discretionary denial of institution is appropriate in these proceedings. This determination is based on the totality of the evidence and arguments the parties have presented. This case presents essentially the same discretionary considerations at those presented in IPR2025-00780 and IPR2025-00781. See, e.g., Samsung Electronics Co. v. GhengisComm Holdings LLC, IPR2025-00780, Paper 11 (Director August 14, 2025) (granting Patent Owner’s request for discretionary denial). Accordingly, that analysis is incorporated here. Id. at 2–3. Although the patents challenged in these proceedings have not been in force for as long as those in IPR2025-00780 and IPR2025-00781, this fact alone does not tip the balance against discretionary denial. The determination to exercise discretion to deny institution is based on a holistic assessment of all of the evidence and arguments presented. Accordingly, the Petition is denied under 35 U.S.C. § 314(a).” slip op. at 2
Discretionary denialPatents in suitUS 11,252,005 - Samsung Electronics Co., Ltd. / Samsung Electronics America, Inc. v. Genghiscomm Holdings LLCInstitution deniedPTAB · Aug 22, 2025 · IPR2025-00790 · APJ Kalyan K Deshpande · IPR · Director review
The Director granted Patent Owner’s discretionary-denial request and denied the petition under § 314(a), so no trial was instituted.
RulingsDirector review decision- Other 314aInstitution denied discretionary otherInstitution denied
“of all relevant considerations, discretionary denial of institution is appropriate in these proceedings. This determination is based on the totality of the evidence and arguments the parties have presented. This case presents essentially the same discretionary considerations at those presented in IPR2025-00780 and IPR2025-00781. See, e.g., Samsung Electronics Co. v. GhengisComm Holdings LLC, IPR2025-00780, Paper 11 (Director August 14, 2025) (granting Patent Owner’s request for discretionary denial). Accordingly, that analysis is incorporated here. Id. at 2–3. Although the patents challenged in these proceedings have not been in force for as long as those in IPR2025-00780 and IPR2025-00781, this fact alone does not tip the balance against discretionary denial. The determination to exercise discretion to deny institution is based on a holistic assessment of all of the evidence and arguments presented. Accordingly, the Petition is denied under 35 U.S.C. § 314(a).” slip op. at 2
Discretionary denialPatents in suitUS 11,223,508
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.