- 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 - Microchip Technology Inc. v. Aptiv Technologies AGSome claims unpatentablePTAB · Aug 18, 2025 · IPR2024-00495 · APJ Terrence W Mcmillin · IPR · Final written decision
Claims 13 and 14 are unpatentable as obvious over Chang and Chang II; claims 18–20 were not shown unpatentable.
RulingsFinal written decision- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner
“Accordingly, in the context of Chang, a POSITA would have been motivated to implement dual-role ports by including a switch (e.g., multiplexer or crossbar) that connects the dual-role port(s) directly to the hub’s upstream port (when the consumer product is configured as a device, i.e., path 48) or to the hub through the bridge (when the consumer product is configured as host, i.e., path 54. Id. at 40–41 (citing Ex. 1013 ¶¶ 182–187). Petitioner’s argument that a skilled artisan would have been motivated to modify Chang to include switching functionality as taught by Chang II and supported by other substantial evidence appears well-reasoned and well-supported. Petitioner argues that “[a] POSITA would have been further motivated to improve Chang in view of Chang II, because Chang II expressly states its relevance to USB hubs.” Pet. 41 (citing Ex. 1013 ¶ 181; Ex. 1015 ¶¶ 27, 40). And, Petitioner argues that “while Chang discloses little regarding its bridge (EX1014, [0020]), Chang II details various aspects of its bridge (EX1015, Title, Figs. 1-2 and 5).” Id. In support of this argument, the Petition provides: Importantly, Chang II further details exemplary switching for either a host- or device-product: “the main feature is the provision of two different transmission paths, so that by automatically detecting the type of device connected (host or slave) the present invention can switch to the proper transmission path.” EX1015, [0021]. In other words, Chang II describes “switch[ing]” to connect a “bridge” transmission path (when the product is host) or “bypass” path (when the product is device). Id., Figs. 1, 5, [0013]. And Chang II further discloses “detection unit 134” for detecting whether the consumer product is host or device. Id., [0038]. Id. (bracketed material in original, footnote omitted). Petitioner contends that “[a]ccordingly, a POSITA would have been motivated, with a high expectation of success, to route the dual-role ports (and products attached thereto) to the appropriate path using a switch.” Id. at 41–42. We determine that this contention is well-reasoned and well-supported. Patent Owner challenges on several grounds the showing regarding” slip op. at 51
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“Id. As discussed above, we determine that any alleged commercial success secondary consideration evidence has not been established to have a nexus to the claimed invention. Accordingly, we consider the evidence of commercial success but accord it little weight in our overall obviousness determination.” slip op. at 60
- Obviousness (§103) › Objective indicia / secondary considerationsNot shown unpatentableDecided for petitioner
“Id. As discussed above, we determine that any alleged commercial success secondary consideration evidence has not been established to have a nexus to the claimed invention. Accordingly, we consider the evidence of commercial success but accord it little weight in our overall obviousness determination.” slip op. at 60
- Strike new argumentDenied
“because the Reply improperly presents new theories of unpatentability with belated supporting evidence that could have been present in the Petition itself.” Paper 37, 1. Patent Owner contends that, in response to an argument Patent Owner made in the Response that “Petitioner’s proposed prior art combination features a structural flaw” (id. at 2), Petitioner’s Reply improperly presents a new argument not found in the Petition (id. at 3–6). As discussed supra (section II.E.3.a.), we determine that, because Patent Owner’s structural flaw argument fails, we do not reach the alleged new argument and evidence that Patent Owner seeks to strike. Accordingly, this motion is moot.” slip op. at 77
Patent outcomesUS 9,619,420 mixed§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 9,619,420 - Microchip Technology Inc. v. Aptiv Technologies AGAll claims unpatentablePTAB · Jul 30, 2025 · IPR2024-00230 · APJ John D Hamann · IPR · Final written decision
Claim 1 is unpatentable as obvious over Chang and Chang II; the Board did not reach the Chang, Chang II, and Chutorash ground.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“We agree with Patent Owner and find that “computer network protocols” is correct in light of the ’072 patent’s disclosure and claim 1. In particular, the ’072 patent teaches that it “generally relates to [USB] connectivity between, for example, mobile consumer devices and vehicle electronic systems.” Ex. 1009, 1:21–23. And the ’072 patent’s teachings focus on common network components (e.g., hub, bridge, ports) and common networking concepts (e.g., master/slave network architecture and bridging) which are used in the USB context, rather than detailed aspects (e.g., signal timing, signal levels, power levels) of the USB protocol. See generally Ex. 1009; see also Ex. 1084, 103:21–104:2, 104:24–105:4; Pet. Reply 4 (citing Ex. 1084,7 100:17–101:12 (acknowledging that Dr. Houh testifies that one of ordinary skill in the art “would know basic USB concepts like bridging, master/slave architecture, etc.”), 102:3–8, 103:21– 104:2, 104:24–105:4). Likewise, claim 1 repeatedly recites “USB,” but does so to identify that all of the components of the data system (i.e., USB ports, USB hub, USB bridge, USB host, USB multiplexing switches) employ the USB protocol. Ex. 1009, 9:15–10:18. As the ’072 patent teaches, “USB 7 Houh Deposition Tr. (2024/12/18, Day 1). technology . . . [wa]s commonly available, familiar to the end user, cost effective and ubiquitous.” Id. at 1:35–37. Thus, although the ’072 patent is taught in the USB context, “computer network protocols” concepts are the focus. For these same reasons, we find unavailing Petitioner’s argument that one of ordinary skill in the art “would have been well-versed in USB standards (including the USB 2.0 and 3.0 Specifications and the OTG Supplement) and the design/deployment of USB hosts, USB devices, and USB hubs, including suitable environments for USB systems.” Pet. 26.” slip op. at 11
- Expert testimonyPetitioner expert discountedOther
“Lastly, we give little weight to Mr. Welch’s testimony regarding the level of one of ordinary skill as he does not indicate what precisely constitutes the basis of his testimony on this issue. See Ex. 1013 ¶ 47.” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Here, Petitioner argues that “embedded USB host” means “USB host physically embedded in a vehicle.” See Pet. 27–28. “Patent Owner does not contend that any claim construction is required.” PO Resp. 5. We agree with Patent Owner that we do not need to construe any term to resolve the disputes between the parties. See, e.g., Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’”). And we afford the claim terms their plain and ordinary meaning.” slip op. at 13
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“that the asserted objective evidence is tied to a specific product that ‘embodies the claimed features, and is coextensive with them.’” Id. (quoting Brown & Williamson Tobacco Corp. v. Philip Morris, Inc., 229 F.3d 1120, 1130 (Fed. Cir. 2000)). In other words, “[a] presumption of nexus requires both that the product embodies the invention and is coextensive with it.” Id. at 1211 (citing Brown, 229 F.3d at 1130). Patent Owner fails to show either of these requirements. First, Patent Owner argues that in his Supplemental Declaration, Dr. Houh “provides on a per limitation basis how [Patent Owner]’s dual role hub meets all limitations of claim 1.” PO Resp. 73 (citing Ex. 2019 ¶ 136). Notably, Patent Owner cites to a single paragraph in this declaration, without providing any specific arguments in its Response that its product practices claim 1. Id. Rather, Patent Owner incorporates its arguments by reference, which is not permitted. See 37 C.F.R. § 42.6(a)(3) (“Arguments must not be incorporated by reference from one document into another document.”). Thus, we do not consider these arguments, and we are not persuaded that Patent Owner’s product practices claim 1. Consolidated Trial Practice Guide November 2019,8 35–36 (citing Cisco Systems, Inc. v. C-Cation Techs., LLC, IPR2014-00454, Paper 12 (PTAB Aug. 29, 2014) (informative)) (“[P]arties that incorporate expert testimony by reference in their petitions . . . without providing explanation of such testimony risk having the testimony not considered by the Board.”).” slip op. at 16
Patent outcomesUS 11,176,072 unpatentableClaim construction§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 11,176,072 - PTAB · Jun 11, 2025 · IPR2025-00115 · APJ Annette R Reimers · IPR · Institution
Instituted review of claims 1–4, 10, 11, 14, 15, 17, 21, 22, 24, 26, 28–30, 32, 33, and 35 on all asserted grounds, based on a reasonable likelihood of prevailing.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“4. Determination as to a Reasonable Likelihood of Prevailing Upon consideration of the arguments and evidence of record, we conclude, for the reasons provided above, that the information presented in the Petition demonstrates a reasonable likelihood that Petitioner would prevail in showing the unpatentability of claims 1–4, 10, 11, 14, 15, 17, 21, and Wampler.” slip op. at 41
- BurdenDecided for patent owner
“With respect to Patent Owner’s assertions about word count limits, the Patent Trial and Appeal Board Consolidated Trial Practice Guide November 2019 (“Consolidated TPG”) states that “deleting spacing between words, or using excessive acronyms or abbreviations for word phrases, in order to circumvent the rules on word count, may lead to a party’s brief not being considered.” Consolidated TPG, 40 (citing Pi-Net Int’l, Inc. v. JPMorgan Chase & Co., 600 F. App’x 774 (Fed. Cir. 2015)). As the basis for denying the Petition, Patent Owner alleges “undue prejudice.” Prelim. Resp. 76. Patent Owner, however, did not raise with the Board, prior to filing its Preliminary Response, any concern with the manner in which Petitioner formatted its Petition. As a result, Patent Owner did not avail itself of the opportunity to seek relief to address any alleged undue prejudice short of denying the Petition through, for example, an increase in the word count for its own brief. See 37 C.F.R. § 42.24(a)(2). Under the circumstances alleged improper formatting.8” slip op. at 12
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends a person of ordinary skill in the art at the time of the invention “would have at least a bachelor’s degree in engineering; knowledge and experience in human circulatory system anatomy and physiology; and at least five years’ experience designing and developing implantable medical devices.” Pet. 6 (citing Ex. 1003 ¶ 18). At this stage of the proceeding, Patent Owner does not contest Petitioner’s proposed level of ordinary skill in the art. See Prelim. Resp. 1–2. We find, for purposes of the appropriate level of skill at the time of the claimed invention and that the level of skill reflected in these references and in the ’517 patent is consistent with the definition of a person of ordinary skill in the art proposed by Petitioner. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 22
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“In sum, Petitioner maintains a narrower construction of “magneto coupling” is correct, and alleges grounds of unpatentability based on both its narrower proposed construction (a construction encompassed by the broader construction), as well as based on the broader construction that Patent Owner does not dispute. We, therefore, find no merit to Patent Owner’s argument that Petitioner’s contention “contradicts itself” or fails to present a “prima facie obviousness position.” See Prelim. Resp. 3. Patent Owner does not dispute the broader construction applied by Petitioner, which encompasses the narrower construction Petitioner proposes. For purposes of this Decision, we apply the broader construction of “magneto coupling,” which encompasses generating a rotating field either by rotating magnets or by an electromagnet / stator.” slip op. at 26
Claim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,674,517 - PTAB · Jun 11, 2025 · IPR2025-00116 · APJ John D Hamann · IPR · Institution
The Board instituted inter partes review on all challenged claims and all asserted grounds, finding a reasonable likelihood that Abbott would prove at least one claim unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“information presented in the petition . . . and any response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2024); see 37 C.F.R. § 42.108 (2024). Upon consideration of the papers, we conclude that the information presented shows that there is a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of at least one challenged claim of the ’077 patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“least a bachelor’s degree in engineering; knowledge and experience in human circulatory system anatomy and physiology; and at least five years’ experience designing and developing implantable medical devices.” Pet. 6 (citing Ex. 1003 ¶ 18). At this stage, “Patent Owner takes no position regarding the appropriate level of skill for a person of ordinary skill in the art.” Prelim. Resp. 1. For purposes of this Decision, we adopt Petitioner’s definition of the level of skill for one of ordinary skill in the art. Pet. 6. We view this definition for the level of ordinary skill as consistent with the ’077 patent and the asserted prior art, and we apply it in our analysis below.” slip op. at 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner
“axially adjacent.” In particular, Petitioner argues in connection with mapping cited art to challenged claims for the Wampler and Akamatsu asserted grounds that “a magnetic element sealed within a rotor is . . . ‘axially adjacent.’” Pet. 20 n.6. Petitioner fails to point to any intrinsic evidence to support this construction. Rather, Petitioner alleges that Patent Owner took this position in the parallel litigation in a chart mapping claim 1 to accused products. Id. (citing Ex. 1019,6 5–7). Petitioner does not explain how Patent Owner’s chart supports Petitioner’s construction here. See id. at 6 Petitioner identifies this exhibit as “Exhibit 13 of Complaint, dated November 27, 2023,” which comprises a claim chart mapping accused products to claim 1. when “a magnetic element [is] sealed within a rotor,” it necessarily means being “axially adjacent,” as Petitioner alleges. See Ex. 1019. Rather, we agree with Patent Owner that this chart instead labels product components that are adjacent to one another as measured along a central axis. Prelim. Resp. 21 (citing Ex. 1019, 6–7). In addition, we agree with Patent Owner that “[t]his [mapping] is in accordance with the plain and ordinary meaning of the claim terms and does not suggest that any component ‘sealed within’ another component would categorically be axially adjacent thereto.” Id. We note that Petitioner applies the plain and ordinary meaning of “axially adjacent” for other asserted grounds, arguing that components which are adjacent to one another along a central axis are “axially adjacent.” E.g., Pet. 55–57. Accordingly, we find, for purposes of this Decision, that the plain and ordinary meaning of “axially adjacent” is being adjacent to one another as measured along a central axis, and does not mean a magnetic element sealed within a rotor. Id. at 20. slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner
“would have found it obvious to include Wampler’s “techniques related to its axially aligned inflow tube” in the HeartMateIII device taught by Bourque. Pet. 81–88. Petitioner argues that Wampler teaches an arrangement for which “[g]ood anatomic compatibility is possible . . . fitting well between the apex of the heart and the adjacent diaphragm.” Id. at 83 (quoting Ex. 1008 ¶ 76) (alterations in original). Petitioner reasons that applying Wampler’s arrangement to Bourque combines old elements performing known functions yielding expected results. Id. at 83–84. According to Petitioner, a person of ordinary skill in the art would have known from Wampler that an axial inflow, as taught by Wampler, would have improved blood flow for the device of Bourque by eliminating the flow restrictive elbow in Bourque. Id. at 84 (citing Ex. 1003 ¶¶ 648–649; Ex. 1007, 2; Ex. 1008 ¶¶ 75–76). Petitioner contends that Bourque recognized certain components, including inflow components, were the cause of clinical troubles, and that Wampler “taught how to eliminate these components that caused clinical troubles–using the inlet to also ‘serve[] as the inflow canula.’” Id. at 85–86 (citing Ex. 1003 ¶¶ 741–747; Ex. 1007, 1, 5; Ex. 1008 ¶¶ 75–76). Petitioner also argues that a person of ordinary skill in the art would have understood Wampler’s arrangement would have reduced “rates of infection” by avoiding placement of the pump in a preperitoneal pocket person of ordinary skill in the art “would have adhered to the express teachings of [Wampler], which focused on ‘[g]ood anatomic compatibility’ so that the device ‘fit[s] well between the apex of the heart and the adjacent diaphragm,’ eliminating the need for a peritoneal pocket dissection associated with increased rates of infection.” Id. at 86–87 (citing Ex. 1003 ¶¶ 651–654; Ex. 1008 ¶ 76) (second and third alterations in original). Petitioner reasons that a person of ordinary skill in the art would have had a reasonable expectation of success because the asserted combination of Bourque and Wampler “would ‘fit[] well between the apex of the heart and the adjacent diaphragm’ due to the pump’s ‘development as a compact’ device and the existence of several similar LVADs that fit well at that position.” Id. at 87 (citing Ex. 1003 ¶¶ 652–655; Ex. 1007, 5). Lastly, Petitioner argues that the asserted combination would have been obvious to try, because “there were a finite number (i.e., two) [of] options for LVAD implantation: the device would be implanted at a preperitoneal pocket, or at the cardiac apex.” Id. at 87–88 (citing Ex. 1003 ¶ 656). At this stage, we find Petitioner’s arguments persuasive, and find that Petitioner has provided sufficiently articulated reasoning with rational underpinning to support combining Wampler and Bourque’s teachings in the manner Petitioner does.” slip op. at 20
Claim construction§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 11,754,077 - PTAB · Jun 10, 2025 · IPR2025-00114 · APJ Annette R Reimers · IPR · Institution
The Board instituted IPR on claims 1, 2, 4, 5, 7, 8, 11, 12, 14–16, and 18–20 on all petitioned grounds, finding a reasonable likelihood of unpatentability over Bourque and Wampler.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review. 35 U.S.C. § 314(b) (2018); 37 C.F.R. § 42.4(a) (2024). An inter partes review may not be instituted “unless . . . the information presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon consideration of the Petition, the Preliminary Response, and the evidence of record, we conclude that the information demonstrates a reasonable likelihood that Petitioner would prevail in showing the unpatentability of at least one of the Challenged Claims. Accordingly, we institute an inter partes review as to the Challenged Claims of the ’879 patent.” slip op. at 2
- BurdenMixed
“Decision we find “axially adjacent” to mean “adjacent to one another as measured along a central axis.” Petitioner does not contend or show in the Petition that Wampler teaches a magnetically driven rotor adjacent to a first magnetic device as measured along a central axis. See Pet. 24–26. In” slip op. at 30
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends a person of ordinary skill in the art at the time of the invention “would have at least a bachelor’s degree in engineering; knowledge and experience in human circulatory system anatomy and physiology; and at least five years’ experience designing and developing implantable medical devices.” Pet. 7 (citing Ex. 1003 ¶ 18). At this stage of the proceeding, Patent Owner does not contest Petitioner’s proposed level of ordinary skill in the art. See Prelim. Resp. 1. We find, for purposes of this appropriate level of skill at the time of the claimed invention and that the level of skill reflected in these references and in the ’879 patent is consistent with the definition of a person of ordinary skill in the art proposed by Petitioner. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 22
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“Magnetic Device” and “Magnetically Driven Rotor” along a “Central Axis”. Ex. 1019, 6. We find nothing in Exhibit 1019 that defines “axially adjacent” to mean “a magnetic element sealed within a rotor,” as Petitioner alleges. In this regard, Patent Owner argues as follows: Exhibit 1019 contains no mention of “a magnetic element sealed within a rotor” or a contention that such a configuration would represent an “axially adjacent” orientation of such components. Instead, [in Exhibit 1019], Patent Owner illustrates a Petitioner product and labels components identified as the claimed magnetically driven rotor and first magnetic device that are adjacent to one another as measured along a central axis. [See Ex. 1019 at 5]. This is in accordance with the plain and ordinary meaning of the claim terms and does not suggest that any component “sealed within” another component would categorically be axially adjacent thereto.” slip op. at 29
Claim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,572,879 - 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 · Jun 9, 2025 · IPR2025-00112 · APJ James A Tartal · IPR · Institution
The Board instituted IPR on claims 1–3, 10, 11, 14, and 17 on all petitioned grounds, finding a reasonable likelihood of success on obviousness over Bourque and Wampler.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review. 35 U.S.C. § 314(b) (2018); 37 C.F.R. § 42.4(a) (2024). An inter partes review may not be instituted “unless . . . the information presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon consideration of the Petition, the Preliminary Response, and the evidence of record, we conclude that the information demonstrates a reasonable likelihood that Petitioner would prevail in showing the unpatentability of at least one of the Challenged Claims. Accordingly, we institute an inter partes review as to the Challenged Claims of the ’357 patent.” slip op. at 2
- BurdenDecided for petitioner
“4. Determination as to a Reasonable Likelihood of Prevailing Upon consideration of the arguments and evidence of record, we conclude, for the reasons provided above, that the information presented in the Petition demonstrates a reasonable likelihood that Petitioner would prevail in showing the unpatentability of claims 1–3, 10, 11, 14, and 17 of the ’357 patent as obvious over Bourque and Wampler.” slip op. at 37
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends a person of ordinary skill in the art at the time of the invention “would have at least a bachelor’s degree in engineering; knowledge and experience in human circulatory system anatomy and physiology; and at least five years’ experience designing and developing implantable medical devices.” Pet. 6 (citing Ex. 1003 ¶ 18). At this stage of the proceeding, Patent Owner does not contest Petitioner’s proposed level of ordinary skill in the art. See Prelim. Resp. 1. We find, for purposes of this appropriate level of skill at the time of the claimed invention and that the level of skill reflected in these references and in the ’357 patent is consistent with the definition of a person of ordinary skill in the art proposed by Petitioner. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 18
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“In sum, Petitioner maintains a narrower construction of “magneto coupling” is correct, and alleges grounds of unpatentability based on both its narrower proposed construction (a construction encompassed by the broader construction), as well as based on the broader construction that Patent Owner does not dispute. We, therefore, find no merit to Patent Owner’s argument that Petitioner’s contention “contradicts itself” or fails to present a “prima facie obviousness position.” See Prelim. Resp. 3. Patent Owner does not dispute the broader construction applied by Petitioner, which encompasses the narrower construction Petitioner proposes. For purposes of this Decision, we apply the broader construction of “magneto coupling,” which encompasses generating a rotating field either by rotating magnets or by an electromagnet / stator.” slip op. at 22
Claim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,351,357 - PTAB · Jun 6, 2025 · IPR2025-00113 · APJ James A Tartal · IPR · Institution
The Board instituted IPR on claims 1–5, 10, 11, 14, 16, and 17, finding a reasonable likelihood that claims 1–5, 10, 11, 14, 16, and 17 are obvious over Bourque and Wampler.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review. 35 U.S.C. § 314(b) (2024); 37 C.F.R. § 42.4(a) (2024). An inter partes review may not be instituted “unless . . . the information presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon consideration of the Petition, the Preliminary Response, and the evidence of record, we conclude that the information demonstrates a reasonable likelihood that Petitioner would prevail in showing the unpatentability of at least one of the Challenged Claims. Accordingly, we institute an inter partes review as to the Challenged Claims of the ’415 patent.” slip op. at 2
- BurdenNot shown unpatentable
“Decision we find “axially adjacent” to mean “adjacent to one another as measured along a central axis.” Petitioner does not contend or show in the Petition that Wampler teaches a magnetically driven rotor adjacent to a first magnetic device as measured along a central axis. See Pet. 24–25. In opposition, Patent Owner argues, and we agree on the current record, as follows: Wampler does not teach or suggest “a magnetically driven rotor . . . axially adjacent to a first magnetic device” based on its imbedding of permanent magnets 88 in the impeller 74 because these components are not adjacent to one another as measured along the central axis of the device. Instead, the magnet segments 88 and impeller 74 are aligned with, and overlap, one another as measured along the central axis in Wampler’s configuration. See Ex. 1008, [where the magnet segments are housed within the impeller blades.] Prelim. Resp. 23 (citing Ex. 1008, ¶ 18, Figs. 3, 4, 7, 9, 11, 13, 15, 17, 19). We find Patent Owner’s arguments refuting Petitioner’s contention that the Challenged Claims would have been obvious over Wampler, alone, have substantial merit. We, therefore, turn to Petitioner’s contentions based on Bourque, in combination with Wampler, which instead rely on Bourque as teaching the “axially adjacent” limitation.” slip op. at 26
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends a person of ordinary skill in the art at the time of the invention “would have at least a bachelor’s degree in engineering; knowledge and experience in human circulatory system anatomy and physiology; and at least five years’ experience designing and developing implantable medical devices.” Pet. 6 (citing Ex. 1003 ¶ 18). At this stage of the proceeding, Patent Owner does not contest Petitioner’s proposed level of ordinary skill in the art. See Prelim. Resp. 1. We find, for purposes of this appropriate level of skill at the time of the claimed invention and that the level of skill reflected in these references and in the ’415 patent is consistent with the definition of a person of ordinary skill in the art proposed by Petitioner. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 18
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner
“We find insufficient support for Petitioner’s assertion that “a magnetic element sealed within a rotor is ‘axially adjacent.’” Pet. 24. Moreover, we find Patent Owner’s definition of the claim language reflects its plain and ordinary meaning and is consistent with the disclosure of the ’415 patent (which illustrates only a “magnetically driven rotor” positioned adjacent to a “first magnetic device” as measured along a central axis). See Ex. 1001, Fig. 2. It is also consistent with the construction Petitioner appears to contend is the correct construction, as applied by Petitioner in, for example, it’s contentions based on the asserted combination of Bourque and Wampler. See Pet. 60 (relying on Bourque’s teaching of a rotor and magnetic device adjacent to one another as measured along a central axis with regard to the “axially adjacent” limitation and not on Wampler’s magnets embedded in the impeller at the same location along a central axis). Accordingly, we find, for purposes of this Decision and based on the current record, that the plain and ordinary meaning of “axially adjacent,” as shown by Patent Owner, is “adjacent to one another as measured along a central axis,” and apply this definition to our analysis of Petitioner’s contentions below.” slip op. at 25
Claim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,376,415
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.