• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  PTAB · Sep 23, 2025 · IPR2024-00647 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 1–36 are unpatentable: claims 1–2, 4–8, 11–12, 14–18, and 21–36 as anticipated, and claims 3, 9, 10, 13, 19, and 20 as obvious.

  RulingsFinal written decision

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

    “We agree with Patent Owner that the phrase “in response to” in claim 1 requires a causal relationship wherein the patient must be tested for MSI-H and, if he or she is determined to be MSI-H or dMMR, then the patient is treated with 10 mg/kg of pembrolizumab every 14 days. In claim 1, a biological sample from the patient must be tested to determine if the cancer is MSI-H and, if so, the patient is treated with a therapeutically effective amount of pembrolizumab. For this reason, if the prior art teaches the limitations of 1) testing a biological sample obtained from a patient having colorectal cancer to determine that the patient’s colorectal cancer is microsatellite instability high or mismatch repair deficient, and 2) treating the patient with a therapeutically effective amount of pembrolizumab if the patient’s colorectal cancer is determined to be microsatellite instability high or DNA mismatch repair deficient, the art anticipates claim 1. We are not persuaded that claim 1 requires or excludes anything else because nothing else is recited in the claim.” slip op. at 9

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “The ’287 patent claims a method of treating a human patient with colorectal cancer having certain characteristics using pembrolizumab and the main prior art reference cited by Petitioner discloses testing pembrolizumab to treat human patients. See Ex. 1001, 24:42–52; Ex. 1005. Accordingly, the relevant field of Patent Owner’s claims is treating human patients, as well as testing existing compounds. In the Decision to institute trial, we adopted Petitioner’s uncontested proposal defining that the level of skill in the art, presented above. Dec. 7– 8. Neither party directs us to evidence of the level of skill in the art beyond what we considered for institution of trial. Having considered Patent Owner’s positions and evidence of record, however, we determine that the level of skill also includes knowledge of and experience with treating cancer patients with immunotherapy compounds, identifying the conditions these patients may have, and understanding the literature regarding clinical trials for such cancers and the associated conditions and immunotherapy.” slip op. at 14

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “In an anticipation analysis, the dispositive question is whether a skilled artisan would ‘reasonably understand or infer’ from a prior art reference that every claim limitation is disclosed in that single reference.” Acoustic Tech., Inc. v. Itron Networked Sols., Inc., 949 F.3d 1366, 1373 (Fed. Cir. 2020). Extrinsic evidence, such as declarations and depositions may be considered when it is used to explain, but not expand, the meaning of a reference. See In re Baxter Travenol Labs., 952 F.2d 388, 390 (Fed. Cir. 1991) (holding that the depositions and declarations of skilled workers were properly used to show what those skilled in the art would have known about the prior art). We credit Dr. Neugut’s and Dr. Oberstein’s testimony about what one of ordinary skill in the art would have understood after reviewing the MSR. slip op. at 34

  Patent outcomesUS 11,649,287 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,649,287
• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  PTAB · Sep 19, 2025 · IPR2024-00650 · APJ Deborah Katz · IPR · Final written decision

  Claims 1–38 are unpatentable: claims 1, 2, 4–7, 11–17, 19–22, and 26–38 are anticipated by the MSR; the remaining claims are obvious over the MSR and cited references.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

    “Petitioner and Patent Owner characterize one of ordinary skill in the art differently. To Petitioner, the ordinarily skilled artisan would be a medical doctor, or a professional in a related field, with experience treating cancer or access to those with experience in clinical studies of therapeutics and to a pathologist with this experience. (See Pet. 11 (citing Ex. 1003 ¶ 19).) To Patent Owner, the ordinarily skilled artisan would have had a medical or graduate-level degree, or equivalent work experience, in the fields of immunology, genetics, or a related field and would have experience (i) conducting immunology research relating to oncology, (ii) conducting genetics research relating to oncology, or (iii) developing and conducting clinical trials on novel cancer therapies in those fields. (See PO Resp. 5–6 (citing Ex. 2072 ¶¶ 31–32, 91–99).) Petitioner emphasizes medical and treatment aspects in its characterization of an ordinarily skilled artisan, whereas Patent Owner emphasizes research aspects. The ’491 patent claims a method of treating a human patient with cancer having certain characteristics using pembrolizumab and the main prior art reference cited by Petitioner discloses testing pembrolizumab to treat human patients. (See Ex. 1001, 25:36–52, 26:24–41, Ex. 1005; see Decision 8–9.) Accordingly, the relevant field of Patent Owner’s claims is treating human patients, as well as testing existing compounds. In light of the extent of the relevant field, we determine that the level of skill in the art relevant to the claims of the ’491 patent is not limited to knowledge of and experience with conducting research relating to oncology or developing and conducting clinical trials, but includes knowledge of and experience with treating cancer patients with immunotherapy compounds, identifying the conditions these patients may have, and understanding the literature regarding clinical trials for such colorectal cancers and the associated conditions and immunotherapy. C. Claim Construction” slip op. at 8

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “Dr. Lonberg, Patent Owner’s witness, does not dispute any of Dr. Neugut’s or Dr. Oberstein’s testimony, but asserts only that Dr. Neugut’s testimony relies only on what was generally done, not on what is expressly disclosed in the MSR. (See Ex. 2072 ¶¶ 105–107.) On cross-examination, Dr. Lonberg agreed with Dr. Oberstein that patients who had received prior cancer therapy were not excluded from the study described in the MSR. (See Ex. 1245, 57:5–58:2, 40:5–14, 49:2–12.) Thus, after considering the evidence cited by each party, we find Dr. Neugut’s and Dr. Oberstein’s testimony to be the most directly relevant and persuasive about what one of ordinary skill in the art would have understood from the MSR itself. We are also persuaded by the lack of a specific contradiction regarding the understanding of one of ordinarily skill in the art by Dr. Lonberg. Even if some patients who had been previously treated with specific drugs were excluded from the study described in the MSR, we are persuaded that one of ordinary skill in the art would have understood the MSR as including other patients who have been treated with a prior cancer therapy drug. We are persuaded that Petitioner has met its burden of proving whether a skilled artisan would reasonably understand or infer that the limitations of claims 13, 28, 32, and 36 were disclosed in the MSR. Petitioner demonstrates what one of ordinary skill in the art would have understood from the MSR, not what it inherently discloses. (Contra PO Resp. 19–22.)” slip op. at 38

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

    “Patent Owner argues that the “in response to” limitation of claim 1 describes administering the claimed treatment only to patients determined to have an MSI-H tumor. (See PO Resp. 6.) But neither claim 1 nor claim 16 includes a limitation excluding the treatment of any patient, such as specifically excluding treatment of any patient who has a tumor that is not MSI-H or dMMR. Neither claim 1 nor claim 16 recites any language differentiating between patients or identifying a patient population to be excluded from treatment. Instead, claims 1 and 16 provide that if the colorectal cancer patient is tested and the cancer is determined to be MSI-H or dMMR, the patient is treated with a therapeutically effective amount of pembrolizumab. We note that the methods of claims 1 and 16 use the open-ended transitional phrase “comprising” that is generally interpreted to not exclude additional, unrecited elements. See Invitrogen Corp. v. Biocrest Mfg., L.P., 327 F.3d 1364, 1368 (Fed. Cir. 2003) (“The transition ‘comprising’ in a method claim indicates that the claim is open-ended and allows for additional steps.”); Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501 (Fed. Cir. 1997) (“‘Comprising’ is a term of art used in claim language that means that the named elements are essential, but that other elements may be added and still form a construct within the scope of the claim.”). The use of the open-ended transitional phrase “comprising” in claims 1 and 16 further suggests to us that any additional steps taken in conjunction with expressly recited method steps, such as the treatment of patients who are not MSI-H or dMMR, are not excluded from the scope of the claim.” slip op. at 13

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

    “discloses species that fall within the scope of claim 1. (See Ex. 2090 ¶ 79; Ex. 1243, 115:5–116:22; Ex. 1085, 673–75; Ex. 1086, 14; Ex. 1003 ¶¶ 25, 67; Ex. 1005, 4.) We are not persuaded that where species falling within the scope of claim 1 were previously known and disclosed in MSR, that claim 1 is patentable over the MSR. See Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381 (Fed. Cir. 2015) (“a reference can anticipate a claim even if it ‘d[oes] not expressly spell out’ all the limitations arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’” the claimed arrangement or combination.” (quoting In re Petering, 301 F.2d 676, 681 (CCPA 1962)). After considering the parties’ arguments and the evidence presented, we are persuaded that the MSR teaches “testing or having tested a biological sample obtained from a patient” having endometrial, small bowel, or gastric cancer and, thus teaches the corresponding limitation of claim 1. d) Element [1.3]: “thereby determining that the patient’s cancer is” slip op. at 26

  Patent outcomesUS 11,634,491 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,634,491
• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  PTAB · Sep 18, 2025 · IPR2024-00625 · APJ Deborah Katz · IPR · Final written decision

  Claims 1–8 are unpatentable: claims 1–4 and 6–8 are anticipated by MSR, and claim 5 is obvious over MSR with the additional marker-testing teachings of Chapelle.

  RulingsFinal written decision

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

    “In an anticipation analysis, the dispositive question is whether a skilled artisan would ‘reasonably understand or infer’ from a prior art reference that every claim limitation is disclosed in that single reference.” Acoustic Tech., Inc. v. Itron Networked Sols., Inc., 949 F.3d 1366, 1373 (Fed. Cir. 2020). Extrinsic evidence, such as declarations and depositions may be considered when it is used to explain, but not expand, the meaning of a reference. See In re Baxter Travenol Labs., 952 F.2d 388, 390 (Fed. Cir. 1991) (holding that the depositions and declarations of skilled workers were properly used to show what those skilled in the art would have known about the prior art). Although Patent Owner argues that a missing element cannot be filled by what an ordinarily skilled artisan would have envisioned, Petitioner’s argument is based on what one of ordinary skill in the art would have understood from what the MSR expressly teaches. (See Pet. 20 (“Indeed, prior art concerning the MSI-H Study indicates that the physicians understood postings on clinicaltrials.gov indicated that patients had ‘metastatic tumors.’ (EX1049, 444; see also EX1050, S4; EX1003, ¶62.)”).) Unlike the facts of Nidec, where a missing signal could have been envisioned but was not present, we are persuaded by the evidence Petitioner presents that those of ordinary skill in the art understood the MSR express disclosure to include patients with unresectable or metastatic tumors because references referring to the study underlying the MSR discuss the inclusion of patients with metastatic tumors in the study. Even if Dr. Neugut’s reasoning that the reference to “measurable” disease in the MSR would have indicated patients having metastatic cancer is flawed, we are persuaded by Petitioner’s evidence of publications referring to the MSR as a study of metastatic colorectal cancer, and we are further persuaded that one of ordinary skill in the art would have understood the MSR to disclose treating patients having metastatic colorectal cancer with pembrolizumab. (See Ex. 1049, 444, Ex. 1050, S4.) Patent Owner does not address this evidence. Instead, Patent Owner acknowledges that “the MSR discloses treating cancer patients that could be within the claimed subset,” but argues that the MSR does not inherently anticipate results later obtained by treating only patients within the claimed subset. (See Pet. Sur- Reply 5–6.) We are persuaded, though, that Petitioner’s challenge is based on what one of ordinary skill in the art would have understood from the MSR (that patients who had an unresectable or metastatic tumor were selected), not on what is inherent to the disclosure of the MSR. We are persuaded that one of ordinary skill in the art at the time would have understood the MSR to teach selecting a patient “who has an unresectable or metastatic,” as required in claim 1. c) Element 1.2: “microsatellite instability-high (MSI-H) or mismatch slip op. at 14

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

    “Patent Owner argues further that the MSR discloses an experimental use that does not qualify as prior art. (See PO Resp. 16–23.) Patent Owner argues that an inventor can be granted latitude to experiment in the public eye until her invention is ready for patenting. (See id. at 16 (citing Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 64 (1998).) According to Patent Owner, the experimental use negation applies to the MSR under a 13-factor analysis provided in Allen Eng'g Corp. v. Bartell Indus., Inc., 299 F.3d 1336, 1353 (Fed. Cir. 2002). (See PO Resp. 17–23.) For example, Patent Owner argues that to establish that treatment of MSI-H cancers was effective, the inventors had to test treatment in humans, there being no animal models, and had to publish the MSR on the government website under federal law. (See PO Resp. 18–20.) Patent Owner argues further that the inventors had control over the MSI-H clinical study and that the field of cancer treatment was highly unpredictable, among other facts. (See id. at 19–20.) Patent Owner argues that “[a]t the time of the MSR’s posting, the claimed invention was not, nor could it have been, ready for patenting. The clinical study that ultimately collected the data reported in the patent specification and supporting the patent claims had not and could not have commenced before the MSR was posted.” (Id. at 21.) In City of Elizabeth, the Supreme Court was concerned that “[i]t is sometimes said that an inventor acquires an undue advantage over the public by delaying to take out a patent, inasmuch as he thereby preserves the monopoly to himself for a longer period than is allowed by the policy of the law,” but held that “when the delay is occasioned by a bona fide effort to bring his invention to perfection, or to ascertain whether it will answer the purpose intended,” the experiment use exception can preserve the inventor’s rights. City of Elizabeth v. Am. Nicholson Pavement Co., 97 U.S. 126, 137 (1877). Because we are not persuaded that Patent Owner could not have filed an earlier application, we are not persuaded that the experimental use doctrine is properly applied in this case. Given that clinical trial protocols published on the ClinicalTrials.gov website have been successfully asserted as prior art in other cases, we are not persuaded by Patent Owner’s arguments that the MSR is not available as prior art against the challenged claims. See, e.g., Salix Pharms., Ltd. v. Norwich Pharms. Inc., 98 F.4th 1056, 1061 (Fed. Cir.), cert. denied, 145 S. Ct. 567 (2024), and cert. denied, 145 S. Ct. 983 (2024). After considering the parties’ arguments and evidence, we are” slip op. at 24

  • Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner

    “In order to show that objective evidence renders the method of claim 5 non-obvious, Patent Owner must show a nexus between the subject matter recited in claim 5 and the evidence of non-obviousness. See Henny Penny Corp. v. Frymaster LLC, 938 F.3d 1324, 1332 (Fed. Cir. 2019) (“to be accorded substantial weight in the obviousness analysis, the evidence of secondary considerations must have a ‘nexus’ to the claims, i.e., there must be ‘a legally and factually sufficient connection’ between the evidence and the patented invention. . . . Ultimately, ‘[t]he patentee bears the burden of showing that a nexus exists.’” (quoting Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387, 1392 (Fed. Cir. 1988), WMS Gaming, Inc. v. Int'l Game Tech., 184 F.3d 1339, 1359 (Fed. Cir. 1999)). Patent Owner argues that there is a nexus between the development and commercialization of pembrolizumab and the patented method of treatment recited in the challenged claims, citing, inter alia, the package insert for Keytruda® (pembrolizumab), but Patent Owner does not direct us to evidence of a nexus to MSI-H or MMR deficient tumors that exhibit instability in the microsatellite markers recited in claim 5 and the unexpected results, commercial success, or other objective measures of non-obviousness flowing from these additional limitations. (See PO Resp. 50–63 (citing Ex. 2129, Ex. 2072 ¶ 190, Ex. 2090 ¶¶ 82–92).) Patent Owner directs us only to evidence regarding determining MSI-H status and then using Keytruda® to treat MSI-H cancer patients, which we determine to be anticipated by the MSR. (See PO Resp. 60.) When evidence of a “secondary consideration [] is exclusively related” slip op. at 34

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

    “(Ex. 1001, 26:19–28.) In Grounds 3 and 5, Petitioner argues, relying on Dr. Neugut’s testimony, that Chapelle teaches standard methods of testing whether a tumor is MSI-H, including determining whether the patient’s tumor exhibits instability in a microsatellite marker, such as BAT-25 or BAT-26. (See Pet. 42 (citing Ex. 1007, 3380, 3383; Ex. 1003 ¶ 107).) For example, Chapelle states that “‘a standard test’ using a ‘[p]anel consisting of … BAT26, BAT25’ has ‘stood the test of time.’” (Ex. 1007 at 3382.) Dr. Neugut testifies that one of ordinary skill in the art would have been motivated to treat a patient with an unresectable or metastatic MSI-H dMMR tumor, wherein the tumor exhibits instability in the BAT-25 and BAT-26 microsatellite marker, and would have expected success in doing so, in light of the teachings of Chapelle. (See Ex. 1003 ¶¶ 105–108.) We find that the record as recounted above supports Petitioner’s challenges of claim 5 in Grounds 3 and 5.” slip op. at 31

  Patent outcomesUS 11,339,219 unpatentable
  § 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,339,219
• Synaffix B.V. v. Hangzhou Dac Biotech Co., Ltd.Some claims unpatentable
  PTAB · Aug 26, 2025 · IPR2022-01531 · APJ Devon Zastrow Newman · IPR · Final written decision

  Claims 1–17, 20, 21, 24, 26, and 29–31 are unpatentable; claims 25 and 32–34 were not shown unpatentable, and the motion to exclude was dismissed as moot.

  RulingsFinal written decision

  • RemandOther

    “review of claims 1–17, 20, 21, 24–26, and 29–34 of the ’682 patent. Paper 2 (“Pet.”), 1, 3. Patent Owner, Hangzhou DAC Biotech Co., Ltd., filed a Preliminary Response (Paper 9, “Prelim. Resp.”). We initially determined that the information presented in the Petition did not establish a reasonable likelihood that Petitioner would prevail with respect to at least one of the challenged claims, and did not institute inter partes review. Paper 17. Petitioner requested Director review of our decision denying institution (Paper 18 (“Request”)). The Director delegated review of the decision to a Delegated Rehearing Panel (“DRP”). Paper 19. Patent Owner was granted the option to file a response to Petitioner’s Request (Paper 22 (“Request Resp.”)). The Delegated Review Panel vacated our decision and remanded the case to this panel with a revised claim construction for claim 1. Paper 23 (“DRP Dec.”). On August 30, 2024, we instituted an inter partes review after remand from the Director. Paper 25 (“Inst. Dec.”). Patent Owner subsequently filed a Patent Owner Response (Paper 31, “Resp.”), Petitioner filed a Reply (Paper 36, “Reply”), Patent Owner filed a Sur-reply (Paper 44, “Sur-reply”), and Petitioner filed a Sur-sur-reply (Paper 48, “Sur-sur-reply”).” slip op. at 2

  • PTAB / AIA Trials › Motions to amend / substitute claimsOther

    “I. Patent Owner’s Motion to Exclude Evidence Patent Owner moves to exclude Exhibits 1089 and 1090. Paper 50. As we did not rely on either of Exhibits 1089 or 1090 in deciding this matter, Patent Owner’s motion is dismissed as moot.” slip op. at 96

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

    “For these reasons, Patent Owner’s arguments and cited evidence also” slip op. at 31

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableNot shown unpatentableMixed

    “function as R2, and the ethyl group may function as R4, which can be a linear alkyl having 1–6 carbon atoms. We note that claim 3 permits R5 and R6 to be absent. For these reasons, the arguments presented in the Petition demonstrate that claim 3 would have been obvious over Singh’s Compound 3 when modified in view of Harris.” slip op. at 73

  Patent outcomesUS 10,131,682 mixed
  § 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,131,682
• Samsung Electronics Co., Ltd. / Samsung Electronics America, Inc. v. Ouraring, Inc.Instituted
  PTAB · Aug 13, 2025 · IPR2025-00147 · APJ Linda E Horner · IPR · Institution

  The Board instituted inter partes review of claims 1–6 and 8–20 after finding a reasonable likelihood that Samsung would prove at least one challenged claim unpatentable.

  RulingsInstitution decision

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

    “Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless the information presented in the petition and the preliminary response shows “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Upon consideration of the Petition and the Preliminary Response, and for the reasons explained below, we determine that Petitioner has shown a reasonable likelihood that it would prevail with respect to at least one of the challenged claims. Thus, we grant the Petition and institute an inter partes review of claims 1‒6 and 8‒20 of the ’124 patent.” slip op. at 2

  • Skill levelSkill level board ownDecided for petitioner

    “At this stage of the proceeding, there is no dispute about the level of ordinary skill in the art.7 Based on the testimony of Dr. Anthony, we determine that a person of ordinary skill in the art would have had at least a four-year degree in electrical engineering, mechanical engineering, biomedical engineering, optical engineering, or related field of study, or equivalent experience, and at least two years’ experience in academia or industry studying or developing physiological monitoring devices such as non-invasive biosensors. A person of ordinary skill in the art would have also been familiar with, for example, sensor system design, including inertial and other motion sensor system design, signal processing, and human-machine interfaces. A higher level of education or skill can substitute for less experience, and vice versa. Ex. 1002 ¶ 29. We determine that the level of ordinary skill in the art adopted above is consistent with the level of technical understanding and competence reflected in the ’124 patent Specification and the asserted prior art references, based on our review of the limited record.” slip op. at 9

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notNot reached

    “We need not reach the issue of whether the preamble is limiting for purposes of determining institution. Even were we to agree with Patent Owner that the preamble is limiting and the claims are limited to a fingerworn ring, at this stage Petitioner has demonstrated that the cited art teaches or suggests such a limitation. That is, Petitioner relies on the fingerring of Schroder for the claimed form factor of a “wearable computing device configured to be worn around a finger of a wearer.” Pet. 22 (Ground 1), 45 (Ground 2, relying on Yuen for adding the functionality of light sources with a photodetector, temperature sensors, and varying the sampling frequency of sensor data acquisition), 56 (Ground 3). Further, to the extent Petitioner contends that Yuen’s toe band or earring is structurally and functionally equivalent to a finger-ring (Pet. 45, 57), Patent Owner has not, at this stage of the proceeding, structurally distinguished a device configured to worn around a finger from a toe band or earring. For instance, Patent Owner has not explained how a device to be worn around a finger differs in size, configuration, or design from a toe band or earring. And the ’124 patent recognizes that “a human being’s finger can come in various different sizes and so should the [wearable computing device].” Ex. 1001, 12:64‒65. For instance, challenged dependent claim 10 recites that the width of the external housing of the wearable computing device is within a range of 3 mm to 8 mm and a thickness of the device is within a range of 1.5 to 3 mm. Id. at 35:8‒12. Should Patent Owner pursue this argument during the proceeding, the record would benefit from further development on the structural similarities and dissimilarities between a fingerworn ring and a toe band.” slip op. at 11

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

    “After considering the parties’ arguments and evidence, we determine that Petitioner’s showing of reasons to combine Mestas and Schröder is sufficient for purposes of granting institution of an inter partes review. Although general similarities between the references are usually not by themselves sufficient to show a reason to combine particular teachings, Petitioner here also provides more particularized contentions, such as “[i]mplementing Mestas’s device in Schröder’s ‘finger-ring’ form factor would ensure a tighter fit than a device worn, e.g., on the user’s arm or wrist, reducing motion artifacts, providing better shielding against ambient light, and permitting higher quality reading from device sensors (e.g., accelerometer, heart rate, temperature)” and that Mestas’s concern with “slippage around a user’s wrist or other body part” would have motivated a person of ordinary skill in the art “to consider placing the device on the finger, as in Schröder, to improve traction and prevent slippage.” Pet. 19‒20 (citing Ex. 1002 ¶ 169; Ex. 1010 ¶ 152). These reasons are sufficient to present a reasonable likelihood of prevailing as to at least one challenged claim based on the proposed combination of Mestas and Schroder for purposes of institution. Patent Owner will have an opportunity to further address Petitioner’s reasoning during the proceeding.” slip op. at 21

  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,188,124
• Neurent Medical Inc. / Neurent Medical Ltd. v. Aerin Medical Inc.All claims unpatentable
  PTAB · Jul 11, 2025 · IPR2024-00282 · APJ Zhenyu Yang · IPR · Final written decision

  Claims 1–4 and 7–9 are unpatentable as obvious, principally over Edwards-’535 and Stern for claims 1–3 and 7–9, and Makower, Edwards-’535, and Stern for claims 1, 2, and 4.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “To the extent Petitioner’s definition could be interpreted to encompass someone who only has experience using or testing unrelated medical devices, we tend to agree with Patent Owner. But it does not follow that experience with the clinical use and testing of medical devices, including those that deliver energy to tissue, would not be relevant background for one of ordinary skill. See Reply 27–28 (identifying evidence that clinical experience is relevant). The devices and methods in the challenged patent and asserted prior art are designed to be used by clinicians. Accordingly, clinical experience using and testing them would inform their design and therefore be relevant experience for one of ordinary skill in the art. For these reasons, we do not adopt Patent Owner’s proposed modification of Petitioner’s definition, which would remove clinical use and testing from the list of activities in Petitioner’s POSITA definition. See PO Resp. 7 (proposing redlines). Instead, after reviewing the record, we adopt Petitioner’s definition as it is consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. Regardless, Petitioner’s declarant, Dr. Martin, is qualified to offer opinions under either definition. Moreover, the parties do not argue that their respective position would be different under either POSITA definition. See PO Resp. 8 (Patent Owner arguing that the challenges fail “[r]egardless of how a POSITA is defined”); Ex. 1083 ¶ 88 (Dr. Martin testifying that his opinions “remain the same regardless of which definition applies”). Accordingly, all of the findings and conclusions herein would be the same under either side’s definition of a POSITA.” slip op. at 8

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

    “Petitioner argues that the part of claim 1’s preamble “to treat rhinitis” is not limiting. Pet. 18. According to Petitioner, the body of claim 1 recites a structurally complete apparatus, and the preamble only states an intended use for the device without limiting the claimed structure. Id. at 18–19. Patent Owner neither addresses this issue, nor proposes any other claim construction. PO Resp. 13 (“Patent Owner believes that no claim constructions are required to resolve the issues raised [in this IPR].”). On this record, we find Petitioner’s argument persuasive and determine that the part of claim 1’s preamble “to treat rhinitis” is not limiting.” slip op. at 9

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

    “techniques of delivering bipolar RF ablation energy through expandable devices to the mucosal tissue of different body cavities.” Id. at 39. According to Petitioner, “combining Edwards-’535 and Stern involves applying Stern’s known bipolar pairing technique to Edwards-’535’s known device that was ready for improvement (because Edwards-’535 omits electrode wiring details) to yield predictable results.” Id. Thus, Petitioner concludes that an ordinarily skilled artisan would have had a reasonable expectation of success when modifying Edwards-’535 in view of Stern. Id. at 38–40. Patent Owner does not dispute Petitioner’s mapping for claim limitations 1[a]-1[c] and 1[f] above, nor does Patent Owner challenge Petitioner’s reasoning for combining Edwards-’535 with Stern. See PO Resp. 14. Patent Owner, however, argues that Petitioner has failed to show Stern teaches limitations 1[d] and 1[e] “because Stern teaches a device comprising only a single pair of bipolar radiofrequency electrodes and a single radiofrequency output channel.” Id. We find that a POSITA would have been motivated to combine the teachings of Edwards-’535 and Stern and would have had a reasonable expectation of success in doing so for the reasons set forth in the Petition. We also find that the articulated combination of Edwards-’535 and Stern teaches all of the limitations of claim 1. We adopt Petitioner’s undisputed analysis of claim limitations 1[a]-1[c] and [f] and reasoning for combining the references, and credit its supporting evidence. See Pet. 26–33, 43–46; Ex. 1002 ¶¶ 84–102, 159–165. Below we address the parties’ arguments regarding the disputed limitations 1[d] and 1[e].” slip op. at 17

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

    “In our view, nothing is missing. Stern teaches that the circuitry in Figure 15 is configured to form multiple pairs of bipolar RF electrodes. Ex. 1033, 12:61–13:2 (explaining “[a]s an example” the closing of certain switches in Figure 15 to activate a bipolar pair between electrodes 220 and 224 and a second bipolar pair between electrodes 222 and 226 and further noting that “[c]learly bipolar operation is not limited to these . . . pair couplings” because other switches could be operated to activate a bipolar pair between electrodes 220 and 222); Ex. 1002 ¶¶ 108–111, 135–138. Indeed, Stern consistently uses the word “pairs,” i.e., the plural not the singular, to describe the bipolar operation of its device. See, e.g., Ex. 1033, 2:36–40, 3:38–40, 12:20–25, 12:29–30, 13:27–44, 20:9–10 (describing the bipolar operation of “pairs” nine times). Accordingly, we disagree with Patent Owner’s argument that Stern teaches a device configured to have at most only a single pair of bipolar RF electrodes. Second, Stern teaches that the “embodiment of FIG. 15 . . . provides flexibility within the bipolar operation so that any pair or any combination of pairs may be utilized together.” Ex. 1033, 13:39–43 (emphasis added). Thus, even if claim 1 did require simultaneous activation of multiple bipolar pairs, we agree with Petitioner that such functionality is also taught by Stern. See Reply 5–6.” slip op. at 20

  Patent outcomesUS 11,766,286 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,766,286
• Neurent Medical Inc. / Neurent Medical Ltd. v. Aerin Medical Inc.All claims unpatentable
  PTAB · Jul 11, 2025 · IPR2024-00278 · APJ Michael A Valek · IPR · Final written decision

  Claims 1, 4–6, 9, 10, 12, 13, and 15–17 are unpatentable as obvious over the asserted prior-art combinations.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner disputes the second part of Petitioner’s definition “because the ‘and/or’ encompasses within the definition . . . persons who only have experience with the clinical use or testing of medical devices.” Resp. 6. According to Patent Owner, one of ordinary skill “would have had more experience than just clinically using medical devices or simply conducting tests with medical devices” Id. at 6–7. To the extent Petitioner’s definition could be interpreted to encompass someone who only has experience using or testing unrelated medical devices, we tend to agree with Patent Owner. But it does not follow that experience with the clinical use and testing of medical devices, including those that deliver energy to tissue, would not be relevant background for one of ordinary skill. See Reply 33–34 (identifying evidence that clinical experience is relevant). The devices and methods in the challenged patent and asserted prior art are designed to be used by clinicians. Accordingly, clinical experience using and testing them would inform their design and therefore be relevant experience for one of ordinary skill in the art. For these reasons, we do not adopt Patent Owner’s proposed modification of Petitioner’s definition, which would remove clinical use and testing from the list of activities in Petitioner’s POSITA definition. See Resp. 7 (proposing redlines). Instead, we apply Petitioner’s definition. Regardless, Petitioner’s declarant, Dr. Martin, is qualified to offer the opinions in his declarations under either definition. Moreover, Patent Owner does not identify any testimony it contends would be different under its POSITA definition. See Ex. 1083 ¶ 103 (Dr. Martin testifying that his opinions “remain the same regardless of which definition applies”). Accordingly, all of the findings and conclusions herein would be the same under either side’s definition of the level of ordinary skill in the art.” slip op. at 9

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

    “Neither side proposes any terms for express construction. Petitioner contends “the Board need not construe any terms because the Challenged Claims are invalid under any reasonable interpretation.” Pet. 20. “Patent Owner believes that no claim constructions are required to resolve the issues raised” in this IPR. Resp. 13. Nevertheless, in their arguments over whether the prior art teaches certain claim elements, each side accuses the other of misinterpreting or reading requirements beyond their ordinary meaning into those terms. See Reply 3–10 (urging that Patent Owner’s arguments read requirements into elements 1[d] and 1[e]); Sur-Reply 9–15 (arguing Petitioner applies an incorrect definition of “radio frequency output channel”). To the extent the parties’ arguments raise any implicit issues of claim construction, we address those issues within the context they are raised in our analysis below. No further express claim construction is necessary for this decision.” slip op. at 10

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

    “We find that one of ordinary skill in the art would have been motivated to combine Edwards-535 and Stern, and had a reasonable expectation of success in doing so for the reasons set forth in the Petition. We also find that the articulated combination of Edwards-535 and Stern teaches all of the limitations of claim 1. We adopt Petitioner’s undisputed analysis of claim elements 1[a]-[c] and [f] and reasoning for combining the references, and credit its supporting evidence. See Pet. 7–14, 17–20; Ex. 1002 ¶¶ 79–103, 113–21. Below we address the parties’ arguments regarding the disputed elements 1[d] and 1[e].” slip op. at 23

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

    “We find that Petitioner has the more persuasive position and has demonstrated that Stern teaches element 1[e]. Petitioner demonstrates Stern’s multiple RF output channels with the annotated version of Figure 15 shown below. Pet. 42–43. As shown by Petitioner’s annotations above, the channel (highlighted in orange) connecting the output received from voltage source 228 to the first bipolar pair (circled in green on the left) is distinct from the channel connecting the output to the second bipolar electrode pair (circled in purple on the right) because depending on which switches are closed, energy travels through a separate connection between those switches and the corresponding electrodes. We agree with Petitioner, and credit Dr. Martin’s testimony, that each of the output channels highlighted in orange in Stern’s Figure 15 above “are output channels as required by the claims because the channels are separately/individually connected to the electrodes” and “control individual pairs of bipolar RF electrodes.” Id. at 43–44; Ex. 1002 ¶¶ 124–128; see also Ex. 1083 ¶ 45 (“an ‘output channel’ connects electrodes and provides the ability to independently control pairs of electrodes”). This understanding of the term “output channel” is consistent with the claim language. Claim 1 recites “multiple radiofrequency output channels” wherein “each pair” of bipolar RF electrodes “is connected with a respective one of the multiple radio frequency output channels.” Ex. 1001, 52:27–33. The RF generator itself and its connection to the output channels is not recited in claim 1. Instead, the claim language focuses on the connection between the electrode pair and its respective output channel. The description in the specification also focuses on the connection to the electrodes and further explains that having a “separate, controlled electrical channel” for “each pair of electrodes” allows for “different regions of the treatment element to be activated separately.” Ex. 1001, 24:45–52, 48:63–65; see also Ex. 1083 ¶ 33 (“[e]very time the patent mentions ‘electrical channel’ or ‘output channel,’ it is referring to connections to electrodes”). This aligns with the depiction of the output channels in the ’318 patent’s figures. See Ex. 1001, Figs. 39–44 (showing RF output channel 961 connected to electrodes). Petitioner demonstrates this in the annotated version of Figure 39 shown below. Reply 8.” slip op. at 29

  Patent outcomesUS 11,033,318 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,033,318
• Neurent Medical Inc. / Neurent Medical Ltd. v. Aerin Medical Inc.All claims unpatentable
  PTAB · Jul 11, 2025 · IPR2024-00277 · APJ Michael A Valek · IPR · Final written decision

  Claims 1–4, 6–12, and 16 are unpatentable as obvious over the Edwards-535, Kong, and Stern combinations, with Edwards-886 added for claim 4.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “To the extent Petitioner’s definition could be interpreted to encompass someone who only has experience using or testing unrelated medical devices, we tend to agree with Patent Owner. But it does not follow that experience with the clinical use and testing of medical devices, including those that deliver energy to tissue, would not be relevant background for one of ordinary skill. See Reply 29–31 (identifying evidence that clinical use and testing experience is relevant). The devices and methods in the challenged patent and asserted prior art are designed to be used by clinicians. Ex. 1083 ¶¶ 5, 14–15 (explaining that clinicians who use such devices gain extensive experience regarding how they work); see also Ex. 1084, 82:13–83:20 (Dr. Bikson testifying that a physician would perform the claimed method steps). Accordingly, clinical experience using and testing them would inform their design and be relevant experience for one of ordinary skill in the art. For these reasons, we do not adopt Patent Owner’s proposed modification of Petitioner definition, which would remove clinical use and testing from the list of activities in Petitioner’s POSITA definition. See Resp. 7 (proposing redlines). Instead, we apply Petitioner’s definition. Regardless, Petitioner’s expert, Dr. Martin, is qualified to offer the opinions in his declarations under either definition and Patent Owner does not identify any testimony it contends would be different under its POSITA definition. See Ex. 1097 ¶ 49 (Dr. Martin testifying that his opinions “remain the same regardless of which definition applies”). Moreover, as explained below, we are not persuaded by Patent Owner’s challenge to Dr. DelGaudio’s qualifications and give his testimony appropriate weight in our analysis. For these reasons, our findings and conclusions would be the same under either side’s definition of the level of ordinary skill in the art.” slip op. at 10

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “Third, nothing suggests that Dr. DelGaudio is not qualified to offer opinions regarding the knowledge and skill of one of ordinary skill in the art. In addition, to his relevant clinical experience, Dr. DelGaudio has experience designing different types of medical devices and consulting with device manufacturers to provide feedback and improve devices used in nasal surgery. Ex. 1083 ¶¶ 9–11. Thus, even if we had adopted a POSITA definition requiring design and development experience, Dr. DelGaudio would qualify as one of ordinary skill in the art because he has such experience in addition to his extensive clinical background. Id. Nevertheless, Patent Owner argues he is “not an individual capable of designing and developing the medical device used in the claimed method” because “Dr. DelGaudio has no experience in designing medical devices that deliver energy to tissue.” Sur-reply 22–24 (emphasis added). That argument is unavailing because such devices and methods of using them such as those recited in the claims of the ’271 patent are often developed by a team of individuals with different backgrounds and expertise. That Dr. DelGaudio working alone may not be capable of designing and developing such a device does not disqualify him from offering testimony from the perspective of one of ordinary skill in the art, particularly as it relates to those claim elements that recite the use of the device as opposed to its technical details.8 Moreover, Dr. DelGaudio was careful not to overstep the bounds of his expertise, relying on testimony from Dr. Martin to confirm his understanding concerning some of the engineering details of the devices themselves. See Ex. 1002 ¶¶ 94, 124, 127, 130, 151; see also Ex. 1083 ¶ 12 (explaining he relied on Dr. Martin to confirm his understanding of teachings in Stern that disclose “implementation details about circuitry used to operate the bipolar electrodes, the physics of delivering energy to tissue, among other things”); Ex. 1004 ¶¶ 66–131 (Dr. Martin testifying regarding a POSITA’s understanding of the prior art as it relates to such elements). Fourth, even if Dr. DelGaudio did not himself qualify as one of ordinary skill, we could still consider his testimony on those matters on which he was qualified. See Consolidated Trial Practice Guide (Nov. 2019), 52, available at https://www.uspto.gov/sites/default/files/documents /tpgnov.pdf (“CTPG”) (“A person may not need to be a person of ordinary skill in the art in order to testify as an expert under Rule 702, but rather must be ‘qualified in the pertinent art.’”) (citing cases). We agree with Petitioner that this would include matters such as the use of the devices described in the cited references in a clinical setting. See Reply 28. 8 Indeed, by its logic, Patent Owner’s own expert would not be one of ordinary skill in the art because he is not himself capable of practicing the claimed method. See Ex. 1084, 24:13–22, 82:19–83:8 (testifying he has never used an RF device to treat a patient and would not himself perform the recited method).” slip op. at 12

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

    “Petitioner’s position is persuasive. Even without taking into account the reasoning based on Baker (which we address separately below), Petitioner has demonstrated a sufficient rationale for incorporating Stern’s arrangement of two rows of bipolar electrode pairs into Edwards-535’s device. Edwards-535 teaches that a plurality of electrodes may be positioned on the surface of its treatment element, but does not specify how those electrodes are arranged or controlled. Ex. 1010, 8:25–27; Ex. 1004 ¶¶ 68–69. Stern teaches a control system for selectively delivering power to bipolar electrode pairs arranged in two rows on the surface of its device that provides even heating and precise control. Ex. 1004 ¶¶ 80–85. As Dr. DelGaudio explains, one of ordinary skill in the art would have regarded these attributes to be particularly beneficial when delivering treatment to the “nasal passages . . . given the uneven morphology of nasal cavity tissue and the proximity of the RF energy delivery to a patient’s brain and other critical tissues within the head.” Ex. 1002 ¶ 94. We credit the testimony of Petitioner’s experts that one of ordinary skill would have been motivated to incorporate Stern’s teachings, including the complementary two-row surface electrode arrangement shown in Figure 19, for these reasons. See Ex. 1002 ¶¶ 93–94; Ex. 1004 ¶¶ 72–73, 75–88, 96–97 (explaining that Stern’s techniques would have been used to improve Edwards-535’s device in a similar way). Petitioner’s reasoning that “arranging electrodes in rows . . . facilitates simple spatial resolution of the applied energy” is also persuasive. See Pet. 47–48. As Dr. Martin explains, one of ordinary skill in the art would have understood that arranging bipolar electrodes in two or more rows was a “common way to arrange such electrodes” (Ex. 1004 ¶ 34) and a “simple way to direct energy to specific locations for treatment would have been to place pairs of electrodes in rows . . . along the device at the locations being treated.” Id. ¶ 95.” slip op. at 41

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

    “Petitioner’s position is persuasive. Stern’s Figure 15 shows bipolar electrodes 220 and 224 in a first horizontal row and electrodes 222 and 226 in a second horizontal row. Stern teaches that bipolar pairs can be formed between various combination of these electrodes resulting in both pairs within a row and pairs formed across two rows. See Ex. 1033, 12:61–13:2 (explaining that “bipolar operation is not limited to [electrode] 220-224 and 222-226 pair couplings” because pairs could also be formed across rows, e.g., between electrodes 220 and 222). Stern’s Figure 19 likewise depicts a plurality of electrodes arranged in two rows. See Ex. 1004 ¶¶ 71–74 (Dr. Martin explaining that the physical arrangement in Figure 19 is complementary to the control structure in Figure 15 and that there are two rows regardless of which electrodes are paired). In bipolar operation, each of these figures depicts “two rows of bipolar electrode pairs” as recited in element 1[a] because there are two rows comprising multiple pairs.15 Patent Owner’s narrower interpretation of the phrase “two rows of bipolar electrode pairs” is not consistent with the intrinsic record. According to Patent Owner and Dr. Bikson, it is not enough that there are two rows of electrodes comprising multiple pairs––rather each row must itself contain multiple pairs. See Resp. 23; Ex. 2001 ¶ 75 (“A row of only two electrodes is not a row of bipolar electrode pairs because a row of only two electrodes has at most a single pair (not multiple pairs).”). As Petitioner points out, Patent Owner’s interpretation assumes that the “s” in “pairs” modifies each row individually, rather than the recited “rows” collectively. But the claim 15 In reply to Patent Owner’s argument that there must be at least three electrodes in a row for that row to contain multiple pairs, Petitioner shows that Stern also discloses rows with three or more electrodes. Ex. 1083 ¶¶ 36– 40; Ex. 1097 ¶¶ 39–41 (identifying rows with three or more electrodes in Stern’s Figures 4a and 19). We need not address that showing in detail because, as explained below, element 1[a] does not require that there be more than one pair in each row. language does not specify that each row has pairs (plural). Rather, given its plain meaning, “two rows of bipolar electrode pairs” encompasses an arrangement like that shown in Stern’s Figure 15. Ex. 1097 ¶ 30 (Dr. Martin explaining that “what is required is (1) more than one bipolar electrode pair that are (2) spread across rows”). This broader understanding is confirmed by the specification of the” slip op. at 35

  Patent outcomesUS 11,241,271 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,241,271
• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  PTAB · Jun 9, 2025 · IPR2024-00240 · APJ Deborah Katz · IPR · Final written decision

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

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

    “claims a method of treating a human patient with colorectal cancer having certain characteristics using pembrolizumab and the main prior art reference cited by Petitioner discloses testing pembrolizumab to treat human patients. (See Ex. 1001, 25:40–50, Ex. 1005; see Decision 8–9.) Accordingly, the relevant field of Patent Owner’s claims is treating human patients, as well as testing existing compounds. Neither party directs us to evidence of the level of skill in the art beyond what we considered for institution of trial. In the Decision to institute trial, we determined that the level of skill in the art relevant to the claims of the ’393 patent is not limited to knowledge of and experience with conducting research relating to oncology or developing and conducting clinical trials. (See Dec. 8–9.) We determined that the level of skill also includes knowledge of and experience with treating colorectal cancer patients with immunotherapy compounds, identifying the conditions these patients may have, and understanding the literature regarding clinical trials for such colorectal cancers and the associated conditions and immunotherapy. (See id.) Because the parties do not present additional evidence or argument, we maintain that determination.” slip op. at 9

  • Expert testimonyPetitioner expert creditedDecided for petitioner

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

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

    “1 requires a causal relationship wherein the patient must be tested for MSI-H and, if he or she is determined to be MSI-H or dMMR, then the patient is treated with 10 mg/kg of pembrolizumab every 14 days. We further agree that this relationship is different than the use of the term “after” in claims 7, 20, and 27, wherein patients must be treated with a different cancer therapy, and wherein the cancer must have later progressed for the treatment to be within the scope of these claims. (Ex. 1001, 25:66–7, 26:44–46, 26:63–64.) In claim 1, a biological sample from the patient must be tested to determine if the cancer is MSI-H and, if so, the patient is treated with a therapeutically effective amount of pembrolizumab. For this reason, if the prior art teaches the limitations of 1) testing a biological sample obtained from a patient having colorectal cancer to determine that the patient’s colorectal cancer is microsatellite instability high or mismatch repair deficient, and 2) treating the patient with a therapeutically effective amount of pembrolizumab if the patient’s colorectal cancer is determined to be microsatellite instability high or DNA mismatch repair deficient, the art anticipates claim 1. We are not persuaded that claim 1 requires or excludes anything else because nothing else is recited in the claim.” slip op. at 12

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

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

  Patent outcomesUS 11,591,393 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,591,393
• Formycon AG v. Regeneron Pharmaceuticals, Inc.Institution denied
  PTAB · Jun 2, 2025 · IPR2025-00233 · APJ Michael A Valek · IPR · Institution

  The Board denied institution under § 314(a) based on the Fintiv factors and denied joinder; it did not reach the merits of the asserted grounds.

  RulingsInstitution decision

  • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied fintivInstitution denied

    “B. The Fintiv Factors and Related Guidance The Board’s precedential decision in Fintiv outlines factors that balance considerations of system efficiency, fairness, and patent quality when a patent owner raises an argument for discretionary denial due to the advanced state of a parallel proceeding, such as the MDL proceeding here. Fintiv 5–6. These factors are: 1. whether the court granted a stay or evidence exists that one may be granted if a proceeding is instituted; 2. proximity of the court’s trial date to the Board’s projected statutory deadline for a final written decision; 3. investment in the parallel proceeding by the court and the parties; 4. overlap between issues raised in the petition and in the parallel proceeding; 5. whether the petitioner and the defendant in the parallel proceeding are the same party; and 6. other circumstances that impact the Board’s exercise of discretion, including the merits. Id. “[I]n evaluating the factors, the Board takes a holistic view of whether efficiency and integrity of the system are best served by denying or instituting review.” Id. at 6.” slip op. at 10

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

    “III. DISCRETION UNDER 35 U.S.C. § 314(A) We begin by addressing Patent Owner’s arguments for discretionary denial. As explained below, we find those arguments persuasive. Thus, we exercise discretion to deny institution of the Petition under 35 U.S.C. § 314(a) without reaching the merits of Petitioner’s asserted grounds of unpatentability.” slip op. at 8

  • PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, deniedDenied

    “35 U.S.C. § 314(a) to deny institution of the Petition and deny the Joinder Motion.” slip op. at 2

  Discretionary denial
  Patents in suitUS 11,084,865

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.