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  • PTAB · Mar 31, 2026 · IPR2024-01450 · APJ Peter D Shapiro · IPR · Final written decision

    Claims 1–4, 6–11, and 13–20 were not shown unpatentable because Dziong and Sathyanath do not teach the claimed sharing definition for existing connections with allocated bandwidth.

    RulingsFinal written decision
    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner

      “First, the claims use present-tense language, “one or more other connections, which have respective bandwidths and which are permitted to share a bandwidth allocation with the new connection.”3 Ex. 1001, claim 1 (emphasis added). The exclusive use of the present tense have indicates “other connections” must have current possession of the bandwidth. For these other connections to share bandwidth with a newly established connection, they must already exist and have bandwidth ready for immediate use, rather than merely holding a dormant “reservation” pending a network failure. See PO Supp. Br. 1. The Federal Circuit addressed a similar situation where the Court found the present-tense limitation “is connected to the computer network” means a device was required to be connected at the” slip op. at 15

    • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

      “combination, do not teach or suggest limitations 1.2 and 1.3 requiring: providing a sharing definition specifying one or more other connections, which have respective bandwidths and which are permitted to share a bandwidth allocation with the new connection, such that a total bandwidth allocated jointly to the new connection and to the other connections in any given segment is equal to a maximum of the requested bandwidth and of the bandwidths of the other connections in the given segment Ex. 1001, limitations 1.2, 1.3 (emphasis added); see PO Resp. 17–22; Sur-reply 4–5, 12–14. As discussed above in Section II.C.2, we interpret “other connections” to mean “existing connections in the network that already have bandwidth allocated to them.” Because the information shared in Dziong and Sathyanath, described below, relates to reserved protection paths, rather than existing connections that have bandwidth that can currently transmit network traffic, the references do not teach or suggest the “other connections” part of the sharing definition in limitations 1.2 and 1.3. Dziong describes advertising, across the network, the amount of bandwidth reserved for recovery on each link that would be activated when a protected link fails. See, e.g., Ex. 1005 ¶ 60; Pet. 36. Once activated, network traffic from a “primary path” failure is rerouted to these recovery paths. See Ex. 1005 ¶¶ 7–9, 70, 83. Petitioner points to this advertising of the reserved bandwidth information as teaching the claimed “sharing definition.” Pet. 33–36 (arguing that the “protection paths [in Dziong] have bandwidth reservations” and “share an overall protection bandwidth reservation”); Reply 21–23. However, since the advertised information only contains information about the recovery paths “that would be activated” upon a primary path failure, such paths are not existing connections that already have bandwidth allocated to them, and therefore do not teach the claimed “other connections” that are part of the sharing definition. See, e.g., Ex. 1005 ¶ 60.” slip op. at 43

    Patent outcomesUS 7,596,088 not shown unpatentable
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 7,596,088
  • PTAB · Jan 14, 2026 · PGR2025-00059 · APJ Devon Zastrow Newman · PGR · Institution

    The Board instituted post-grant review of claims 1–4 on all four asserted grounds, finding a sufficient preliminary showing of obviousness and lack of enablement.

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

      “V. CONCLUSION Petitioner has, at this stage, established that it will more likely than not prevail in showing that at least one of the challenged claims is unpatentable. This determination is, however, based on a preliminary record and is not final on any issues of patentability. We will make a final determination on the patentability of the challenged claims, as necessary and applying the preponderance of the evidence standard, based on a fully developed record through trial. VI. ORDER In consideration of the foregoing, it is hereby: ORDERED that, pursuant to 35 U.S.C. § 324(a) post grant review of claims 1–4 of the ’233 patent is hereby instituted on the grounds set forth in the Petition, commencing on the entry date of this Order, and pursuant to 35 U.S.C. § 324(d) and 37 C.F.R. § 42.4, notice is hereby given of the institution of a trial; and” slip op. at 40

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Patent Owner does not proffer a description of a POSA. See generally, Prelim. Resp. For the purposes of this decision, on the record at this time, we find that Petitioner’s definition appears consistent with the level of skill shown in the prior art references of record, and apply it herein. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). We invite the parties to further address the definition of a POSA during trial should they find it necessary.” slip op. at 7

    • Expert testimonyPetitioner expert discountedDecided for patent owner

      “In addition, the opinion stated in the Pomper Declaration that “the term of ‘low molecular weight’ is well accepted in the chemical arts” and the declarant “recognize[s] that low molecular weight compounds would have a molecular weight of typically from about 50 Daltons to about 1,500 Daltons” is offered by a co-inventor. We, as factfinder, have discretion to weigh the credibility of expert witnesses and to give each item of evidence such weight as appropriate. See In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”). In this case, we find that the published references on metabolites do not support the opinion. In re Am. Acad. of Sci. Tech Ctr., 367 F.3d at 1368 (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”) US-121, of which Dr. Pomper is lead inventor, also uses the term “low molecular weight”—without further characterization of the term—and is uninformative as to the meaning of the term. See Ex. 1006, ¶ 12. In addition, Patent Owner’s definition does not appear to apply to all compounds claimed in US-121.5” slip op. at 11

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

      “limited to Patent Owner’s proposed “from about 50 Daltons to about 1,500 Daltons.” The cited evidence relied on in the Pomper Declaration to define “low molecular weight” as a term well accepted in the chemical arts relates to metabolomics and metabolites. See Ex. 1002, 169, (specifically, ¶ 17 of Dr. Pomper’s declaration). Patent Owner admits that Dr. Pomper’s testimony is about molecules that differ from the claimed imaging and radiotherapeutic agents targeting FAP-α, but argues that the testimony is still relevant for purposes of explanation. Prelim Resp. 21. While it may be relevant, the testimony is not persuasive in light of the Specification. We find the uncontested fact that several of the B moieties alone—without the A moiety or L linker—specifically identified in the ’233 patent fall outside of Patent Owner’s proposed definition persuasive, as we normally do not interpret claim terms in a way that excludes examples disclosed in the specification. See, e.g., Verizon Servs. Corp. v. Vonage Holdings Corp., 503 F.3d 1295, 1305 (Fed. Cir. 2007) (rejecting proposed claim interpretation that would exclude disclosed examples in the specification). The cases cited by Patent Owner supporting that a claim term may be construed to exclude embodiments where the prosecution history supports such construction are factually distinguishable from the instant case as they regard instances of specific prosecution history disclaimer, clear prosecution disavowal, or relate to a specific definition of the terms in the Specification for the term being construed. Here, “low molecular weight” is not defined in the Specification, but, as Petitioner argues (see Pet. 21–25) is characterized as “demonstrat[ing] faster pharmacokinetics and a higher specific signal within clinically convenient times after administration” and that it “can be synthesized in radiolabeled form more easily.” Ex.1001, 13:33–50, 14:56– 16:14, 17:9–20. We are persuaded by the testimony of Dr. Zeglis, Petitioner’s declarant, that compounds weighing over 1500 Da may share those same behaviors, along with certain identified B moieties disclosed as embodiments. See Ex. 1003 ¶ 83.” slip op. at 10

    Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
    Patents in suitUS 12,115,233
  • PTAB · Jan 13, 2026 · IPR2024-00913 · APJ Justin T Arbes · IPR · Final written decision

    Claims 1, 2, 4, 6, 7, 11, 12, 14, 16, and 17 are unpatentable over Blease, Weyman, and Hu, with some claims also over Deng; claims 8–10 and 18 were not shown unpatentable.

    RulingsFinal written decision
    • Expert testimonyPetitioner expert discountedOther

      “disclosure in Weyman (or Blease) for deactivating and activating ports, or performing certain actions in the time between such actions. Again, the only portion of Weyman cited pertains to a request to join the fabric from a processing unit having a “default” configuration, which does not relate to the timing or sequence of events in initialization. See Ex. 1006 ¶¶ 69, 156, 161–162; Ex. 1103 ¶¶ 93–94. Nor does Dr. Lavian point to any other evidence in the record supporting his conclusion that a person of ordinary skill in the art would have “ensure[d] that the processing unit is deactivated prior to being updated for use . . . and then activate[d] the processing unit after updating.” See Ex. 1103 ¶ 94. Accordingly, we give little weight to Dr. Lavian’s conclusory opinion” slip op. at 75

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableUnpatentable

      “See Axonics, 73 F.4th at 957; Allied Erecting, 825 F.3d at 1381; Mouttet, 686 F.3d at 1332–33. Petitioner’s position is that, based on the teachings of Weyman, a person of ordinary skill in the art would have modified Blease’s system to distribute the functionality of control unit 44 (including its existing multicast forwarding information 48 used by OIF mapper 50). See Pet. 23–26, 38; Fleming v. Cirrus Design Corp., 28 F.4th 1214, 1222 (Fed. Cir. 2022) (“That the proposed combination of [two references]—rather than one of the individual references—discloses the disputed claim limitations does not defeat the Board’s conclusion of obviousness. In this case, it is sufficient that a person of ordinary skill in the art would have been motivated to combine the prior art in a way such that the combination discloses the claim limitations.”).” slip op. at 55

    • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

      “10 In the Cisco IPR, we determined that Cisco had proven claims 8 and 18 to be unpatentable based on a different combination of references (identified as Weyman, Jain, and LeMaire), finding that limitation 8[f.ii] was taught by Jain and LeMaire. IPR2024-00506, Paper 38 at 58–77. As explained herein, we are not persuaded by Petitioner’s arguments in this proceeding that limitation 8[f.ii] is taught or suggested by Weyman. Also, in the Decision on Institution in this proceeding, the Board found that there were questions as to Petitioner’s showing for limitation 8[f.ii] and declined to reach a conclusion on whether Petitioner had shown a reasonable likelihood of prevailing on its asserted ground based on Blease and Weyman. Dec. on Inst. 43.” slip op. at 71

    Patent outcomesUS 8,014,394 mixed
    § 103 obviousnesscites KSR · Graham
    Patents in suitUS 8,014,394
  • PTAB · Dec 9, 2025 · IPR2024-00893 · APJ Justin T Arbes · IPR · Final written decision

    Claims 3, 8, 11, 12, 15, 20, 23, and 24 are unpatentable as obvious over Gai and IEEE 1999.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner argues that at the time of the application for the ’986 patent (January 2002), a person of ordinary skill in the art would have had “a bachelor’s degree in electrical engineering or a related field, plus at least two years of industry experience or graduate-level academic experience with computer networking.” Pet. 20. In the Decision on Institution, the Board agreed with and applied Petitioner’s proposed definition, removing the phrase “at least” to avoid unnecessary ambiguity. Dec. on Inst. 18–19. Patent Owner uses Petitioner’s proposed definition for its Response. PO Resp. 5. Neither party made any further argument regarding the level of ordinary skill in the art in its papers during trial. In the Cisco IPR, we adopted a similar definition, determining that a person of ordinary skill in the art would have had “a bachelor’s degree in computer science, computer engineering, electrical engineering, or in an equivalent field, or approximately two years of experience working in the field of information technology and networking,” where “[l]ack of professional experience can be substituted by additional education, and vice versa.” IPR2024-00505, Paper 29 at 10–11 (alteration in original); see Dec. on Inst. 19 n.7 (noting the proposed definition in the Cisco IPR). Based on the full record developed during trial, including our review of the ’986 patent and the types of problems and solutions described in the ’986 patent and cited prior art, we adopt the same definition of the level of ordinary skill in the art as the Cisco IPR and apply it for purposes of this Petitioner’s similar proposed definition in this proceeding.” slip op. at 12

    • Expert testimonyPetitioner expert creditedDecided for petitioner

      “Gai discloses entering an Enable_Uplinkfast command at an access switch (e.g., access switch 114) to block a failed port (e.g., the root port) and configure the access switch to send dummy traffic upstream through a new active port. . . . When modified in view of IEEE 1999’s disclosure that self-healing network traffic can advantageously be sent both upstream and downstream, the command would be entered at a backbone switch (e.g., backbone switch 122) to block a failed port (e.g., a designated port connected to access switch 114) and configure the backbone switch to send dummy traffic downstream to an access switch (e.g. access switch 114) through a new active port. While Gai uses its protocol signaling command, Enable_Uplinkfast, to send dummy traffic through a new root port, [a person of ordinary skill in the art] would deem it an obvious implementation detail to modify the parameters of the port on a backbone switch. See Ex. 1003 ¶ 139 (citing Ex. 1005, col. 6, ll. 39–46).” slip op. at 34

    • Prior constructionPrior construction adoptedDecided for petitioner

      “In the Cisco IPR, we addressed four claim terms in the final written decision: “access switch” and “edge switch,” which appear in independent claims 1 and 13 and various dependent claims, and “downstream” and “upstream,” which appear in claims 11, 12, 23, and 24. IPR2024-00505, Paper 29 at 11–14. We interpreted “access switch” to mean “a switch with ports that connect to LANs and/or to other network endpoints, such as user computer systems,” interpreted “edge switch” to mean “a core switch that is directly connected to an access switch,” interpreted “downstream” to mean “away from the root switch,” and interpreted “upstream” to mean “toward the root switch.” Id. As noted above, Patent Owner did not appeal that decision. We incorporate herein our previous analysis in the Cisco IPR, but note that none of the analysis of the disputed issues below depends on such determine whether Petitioner has met its burden to prove unpatentability of the challenged claims. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“Because we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy,’ we need not construe [a particular claim limitation] where the construction is not ‘material to the . . . dispute.’” (emphasis added) (citation omitted)).” slip op. at 13

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

      “1999, supported by the testimony of Mr. McNair, which we credit, is persuasive. See Pet. 25–30, 40–46; Ex. 1003 ¶¶ 132–145, 165–174. Based on the full trial record, we find that Gai and IEEE 1999 teach limitation [1E] and that a person of ordinary skill in the art would have been motivated to combine their teachings in the manner described by Petitioner. Based on all of the evidence of record, we determine that Petitioner has proven, by a preponderance of the evidence, that claim 3 would have been obvious over Gai and IEEE 1999 under 35 U.S.C. § 103(a). 4. Claims 8, 15, and 20 Claim 8 depends indirectly from independent claim 1. Claims 15 and 20 depend indirectly from independent claim 13, which is similar to claim 1 but recites a network switching device rather than a method. As to independent claim 13, Patent Owner refers to its earlier arguments regarding claim 1, asserting that limitation [13C] is “substantially similar” to limitation [1E]. PO Resp. 14–15. We disagree with Patent Owner’s arguments for the reasons explained above. See supra Section II.D.3.b. Patent Owner does not argue dependent claims 8, 15, and 20 separately from their respective parent claims 1 and 13. See PO Resp. 19. We have reviewed Petitioner’s contentions and supporting evidence, including the testimony of Mr. McNair, and are persuaded that Petitioner has proven, by a preponderance of the evidence, that claims 8, 15, and 20 would have been obvious based on Gai and IEEE 1999 under 35 U.S.C. § 103(a), for the reasons stated by Petitioner. See Pet. 21–46, 48–52, 55–59; Ex. 1003 ¶¶ 113–175, 179–185, 194–203.” slip op. at 41

    Patent outcomesUS 6,917,986 unpatentable
    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 6,917,986
  • PTAB · Nov 17, 2025 · IPR2024-00648 · APJ Devon Zastrow Newman · IPR · Final written decision

    Claims 1–30 are unpatentable: claims 1–2, 4–7, 9–12, 14–17, and 19–30 are anticipated by the MSI-H Study Record; claims 3, 8, 13, and 18 are obvious over the cited combinations.

    RulingsFinal written decision
    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner

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

    • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityReference is prior artDecided for petitioner

      “Patent Owner does not direct us to evidence that it attempted to file any patent application before the publication date of the MSI-H clinical study and was denied an earlier filing date. Contrary to Patent Owner’s argument that it could not file a patent application without results from the MSI-H clinical study, we note that the inventors filed a provisional patent application on November 13, 2014, which, although also filed more than a year after the publication of the MSI-H clinical study, disclosed no clinical results or data. Ex. 1001, cover; Ex. 1030, 1. After considering the parties’ arguments, we are not persuaded by Patent Owner’s assertion that the inventors could not have filed an earlier application to at least attempt to secure a priority date before the MSI-H clinical study was publicly available. an earlier filing date. Instead, we are persuaded by Petitioner’s argument that because the MSI-H clinical study was published before the inventors filed an application to protect their patent rights the MSI-H clinical study is prior art for the information it discloses. Accordingly, we proceed to analyze Petitioner’s contentions in Ground 1.” slip op. at 24

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

      “the genus disclosed in the MSI Study Record and does not argue or provide evidence to show that one of ordinary skill in the art could have envisaged each species within that genus. PO Resp. 11–14. We are not persuaded that either the size of the genus in the MSI Study Record or whether one of ordinary skill in the art would have been able to envisage every species within it is dispositive of whether the MSI Study Record anticipates claim 1, where one of ordinary skill in the art would have known that specific cancers recited in claim 1 would be included in the MSI Study Record. As Petitioner argues, claim 1 requires that “a patient…selected from the group consisting of [the listed cancers]” be tested and treated. Pet. Reply 10 (emphasis original). Claim 1 does not require that the patient have each and every one of the sixteen listed cancers to anticipate the claim. Rather, claim 1 requires testing a sample from “a patient” with one of the recited types of cancer and treating the patient. See Brown v. 3M, 265 F.3d 1349, 1351 (Fed. Cir. 2001) (“When a claim covers several structures or compositions, either generically or as alternatives, the claim is deemed anticipated if any of the structures or compositions within the scope of the claim is known in the prior art.”).” slip op. at 31

    • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

      “In contrast, the testimony of Patent Owner’s witness, Dr. Goldberg, supports Petitioner’s argument of the knowledge in the art at the time, wherein Dr. Goldberg testifies that “[w]hile many clinical oncologists were aware that patients with Lynch Syndrome had a defect in DNA mismatch repair, they associated MSI testing with young onset colorectal and endometrial cancer and patients with a family history of colorectal and/or endometrial cancer.” Ex. 2090 ¶ 79. Similarly, during his deposition, Dr. Goldberg also agreed that endometrial, gastric, and small-bowel cancers would come to mind when he saw a reference to MSI-high non-colorectal cancer. See Ex. 1243, 115:5–116:22 (Q. And so does endometrial cancer come to mind when you see reference to MSI-high non-colorectal cancers? . . . A. Yes. Q. As . . . a person of skill in the field, when you see reference to MSI-high non-colorectal cancers, does gastric cancer come to mind? . . . A. comes to mind. So the answer is yes. Q. As a person of skill in the field, when you see reference to MSI-high non-colorectal cancers, does small bowel cancer come to mind? . . . A. Yes.”). Patent Owner does not direct us to other evidence contradicting Petitioner’s argument that MSI-H was known to occur in endometrial, small bowel, and gastric cancer. Pet. 18.” slip op. at 30

    Patent outcomesUS 11,643,462 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,643,462
  • PTAB · Nov 6, 2025 · IPR2024-00623 · APJ Devon Zastrow Newman · IPR · Final written decision

    Claims 1–7 are unpatentable: claims 1–3 and 5–7 are anticipated by the MSI-H Study Record, and claim 4 is obvious over the MSI-H Study Record and other cited references.

    RulingsFinal written decision
    • Expert testimonyPetitioner expert creditedDecided for petitioner

      “On balance, we find Petitioner’s evidence more persuasive of what one of ordinary skill in the art would have understood from the MSI-H Study Record. We find Dr. Neugut’s and Dr. Oberstein’s testimony, and Dr. Lonberg’s lack of clear testimony to the contrary, persuasive as to this issue. In addition, we are not persuaded by the case law cited by Patent Owner regarding inherent anticipation. See PO Resp. 6–7. Rather, we agree with Petitioner that the correct inquiry is whether the skilled artisan would have understood that all limitations are disclosed in the prior art. See Pet. 34–35; Pet. Reply 12–13. In light of the cited testimony, we are persuaded that Petitioner has met its burden of proving that a skilled artisan would reasonably have understood or inferred that the limitation for a patient having received a prior cancer therapy drug to treat the tumor was disclosed in the MSI-Study Record. Petitioner demonstrates what one of ordinary skill in the art would have understood from the MSI-H Study Record, not what it inherently discloses. Contra PO Resp. 6–9.” slip op. at 22

    • Skill levelSkill level board ownDecided for petitioner

      “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 ’974 patent is not limited to knowledge of and experience with conducting research relating to oncology or developing and conducting clinical trials, but includes knowledge of and experience with treating cancer patients with immunotherapy compounds, identifying the conditions these patients may have, and understanding the literature regarding clinical trials for such colorectal cancers and the associated conditions and immunotherapy.” slip op. at 9

    • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
    Patent outcomesUS 11,325,974 unpatentable
    § 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,325,974
  • PTAB · Nov 4, 2025 · IPR2024-00624 · APJ Sheridan K Snedden · IPR · Final written decision

    Claims 1–4, 6–10, and 12–15 are unpatentable, principally because the MSI-H Study Record anticipates them.

    RulingsFinal written decision
    • Skill levelSkill level board ownDecided for petitioner

      “Pet. 12 (citing Ex. 1003 ¶ 19). To Patent Owner, the ordinarily skilled artisan would have had a medical or graduate-level degree, or equivalent work experience, in the fields of immunology, genetics, or a related field and would have experience (i) conducting immunology research relating to oncology, (ii) conducting genetics research relating to oncology, or (iii) developing and conducting clinical trials on novel cancer therapies in those fields. PO Resp. 6 (citing Ex. 2072 ¶¶ 31–32, 86–94). Thus, Petitioner and Patent Owner characterize one of ordinary skill in the art differently. Petitioner emphasizes medical and treatment aspects in its characterization of an ordinarily skilled artisan, whereas Patent Owner emphasizes research aspects.” slip op. at 8

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

      “The parties do not assert constructions of any terms recited in the challenged claims other than that their ordinary and customary meanings should apply. Pet. 11–12; PO Resp. 6. We determine that no express construction of any claim term is necessary to resolve the dispute between the parties. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We construe” slip op. at 7

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

      “record, we are persuaded that the results recited in claim 1 would follow from the steps taught in the MSR, for the reasons and based on the evidence Petitioner cites above. For these same reasons, we are unpersuaded by Patent Owner’s argument that it was unknown whether the amount of pembrolizumab recited in claim 1 would be effective in producing an improved outcome compared to a reference patient without a tumor that was not MSI-H or dMMR, and Patent Owner does not dispute that the amount of pembrolizumab disclosed in the MSR (10 mg/kg every 14 days; see Ex. 1005, 4) is the same as the amount provided in the ’975 patent as being effective (10 mg/kg every 14 days; Ex. 1001, 8:48–52, 13:50–52). Regardless of the inventors’ intent in publishing the MSR as a Stage II clinical trial on the www.clinicaltrials.gov website, as discussed above, we determine that the MSR teaches selecting a patient with a metastatic MSI-H or dMMR tumor and administering an amount of pembrolizumab that would be effective. See, e.g., Ex. 1005, 4 (Arms and Interventions). The result of drug treatment inherently follows its administration. The MSR does not merely suggest that pembrolizumab may be useful in some unidentified subset of patients or suggest that some unidentified drug may be useful for MSI-H cancer patients. Instead, the MSR discloses selecting a patient with a condition recited in claim 1 and treating with the drug at the amount recited in claim 1. Contra Metabolite Labs. Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1367 (Fed. Cir. 2004) (holding that the prior art did not inherently anticipate where it failed to mention specific vitamin deficiencies, instead merely inviting further experimentation to find associations with metabolic perturbations). requirement, efficacy is inherent in carrying out the claim steps,” referring to a claimed method of treating or preventing stroke, which was held to be anticipated by the publication of a proposed study. 677 F.3d at 1381. Patent Owner attempts to distinguish the size and apparent surety of the study in Montgomery from the MSR. PO Resp. 15. But because we find that the MSR teaches performing the steps recited in claim 1 for the purpose of determining and treating MSI-H cancer, we are persuaded that the MSR inherently discloses the results of selection of patients and administration of the drug treatment recited in those steps. See Bristol-Myers, 246 F.3d at 1376. Whether or not the MSR could have provided results or was sufficient for full regulatory approval does not change that the MSR teaches Patent Owner’s claimed steps. We have no reason to doubt that the disclosure in the MSR of the steps recited in claim 1 produces the efficacy element required in claim 1, whether or not this efficacy was disclosed in the MSR or was known when it was published. See Mehl/Biophile, 192 F.3d at 1366 (“Where, as here, the result is a necessary consequence of what was deliberately intended, it is of no import that the article’s authors did not appreciate the results.”).” slip op. at 21

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

      “use that does not qualify as prior art. PO Resp. 18–25. Patent Owner argues that an inventor can be granted latitude to experiment in the public eye until her invention is ready for patenting. Id. at 18 (citing Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 64 (1998). According to Patent Owner, the experimental use negation applies to the MSR under a 13-factor analysis provided in Allen Engineering Corp. v. Bartell Industries, Inc., 299 F.3d 1336, 1353 (Fed. Cir. 2002). PO Resp. 19–25. For example, Patent Owner argues that to establish that treatment of MSI-H cancers was effective, the inventors had to test treatment in humans, there being no animal models, and had to publish the MSR on the government website under federal law. Id. at 20–22. Patent Owner argues further that the inventors had control over the MSI-H clinical study and that the field of cancer treatment was highly unpredictable, among other facts. Id. at 21. Patent Owner argues that “[a]t the time of the MSR’s posting, the claimed invention was not, nor could it have been, ready for patenting. The clinical study that ultimately collected the data reported in the patent specification and supporting the patent claims had not and could not have commenced before the MSR was posted.” Id. at 23. sometimes said that an inventor acquires an undue advantage over the public by delaying to take out a patent, inasmuch as he thereby preserves the monopoly to himself for a longer period than is allowed by the policy of the law,” but held that “when the delay is occasioned by a bona fide effort to bring his invention to perfection, or to ascertain whether it will answer the purpose intended,” the experiment use exception can preserve the inventor’s rights. City of Elizabeth v. Am. Nicholson Pavement Co., 97 U.S. 126, 137 (1877). Because we are not persuaded that Patent Owner could not have filed an earlier application, we are not persuaded that the experimental use doctrine is properly applied in this case. Given that clinical trial protocols published on the ClinicalTrials.gov website have been successfully asserted as prior art in other cases, we are not persuaded by Patent Owner’s arguments that the MSR is not available as prior art against the challenged claims. See, e.g., Salix Pharms., Ltd. v. Norwich Pharms. Inc., 98 F.4th 1056, 1061 (Fed. Cir.), cert. denied, 145 S. Ct. 567 (2024), and cert. denied, 145 S. Ct. 983 (2024).” slip op. at 24

    Patent outcomesUS 11,325,975 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,325,975
  • PTAB · Oct 28, 2025 · IPR2024-00622 · APJ Sheridan K Snedden · IPR · Final written decision

    Claims 1–28 are unpatentable: claims 1, 6–11, 13–20, 22–24, and 26–28 as anticipated by the MSI-H Study Record; claims 2–5, 12, 21, and 25 as obvious.

    RulingsFinal written decision
    • BurdenUnpatentable

      “(“the claimed process here is not directed to a new use; it is the same use, and it consists of the same steps as described by [the prior art]. Newly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.”). After analysis of the full record, we are persuaded that the results recited in claim 1 would follow from the steps taught in the MSR, for the reasons and based on the evidence Petitioner cites above. For these same reasons, we are unpersuaded by Patent Owner’s argument that it was unknown whether the amount of pembrolizumab recited in claim 1 would be effective in producing an improved outcome compared to a reference patient without a tumor that was not MSI-H or dMMR, and Patent Owner does not dispute that the amount of pembrolizumab disclosed in the MSR (10 mg/kg every 14 days; see Ex. 1005, 4) is the same as the amount provided in the ’356 patent as being effective (10 mg/kg every 14 days; Ex. 1001, 8:48–52, 13:50–52). Regardless of the inventors’ intent in publishing the MSR as a Stage II clinical trial on the www.clinicaltrials.gov website, as discussed above, we determine that the MSR teaches selecting a patient with a metastatic MSI-H or dMMR tumor and administering an amount of pembrolizumab that would be effective. See, e.g., Ex. 1005, 4 (Arms and Interventions). The result of drug treatment inherently follows its administration. The MSR does not merely suggest that pembrolizumab may be useful in some unidentified subset of patients or suggest that some unidentified drug may be useful for MSI-H cancer patients. Instead, the MSR discloses selecting a patient with a condition recited in claim 1 and treating with the drug at the amount recited in claim 1. Contra Metabolite Labs. Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1367 (Fed. Cir. 2004) (holding that the prior art did not” slip op. at 22

    • Skill levelSkill level board ownDecided for petitioner

      “Petitioner and Patent Owner characterize one of ordinary skill in the art differently. To Petitioner, the ordinarily skilled artisan would have been a medical doctor, or a professional in a related field, with experience treating cancer or access to those with experience in clinical studies of therapeutics and to a pathologist with this experience. Pet. 11 (citing Ex. 1003 ¶ 19). To Patent Owner, the ordinarily skilled artisan would have had a medical or graduate-level degree, or equivalent work experience, in the fields of immunology, genetics, or a related field and would have experience (i) conducting immunology research relating to oncology, (ii) conducting genetics research relating to oncology, or (iii) developing and conducting clinical trials on novel cancer therapies in those fields. PO Resp. 5–6 (citing Ex. 2072 ¶¶ 31–32, 86–94). Petitioner emphasizes medical and treatment aspects in its characterization of an ordinarily skilled artisan, whereas Patent Owner emphasizes research aspects. The ’356 patent claims a method of treating a human patient with cancer having certain characteristics using pembrolizumab and the main prior art reference cited by Petitioner, MSR, discloses testing Ex. 1005. Accordingly, the relevant field of Patent Owner’s claims is treating human patients for cancer, as well as testing existing compounds for use in treatment modalities. In light of the extent of the relevant field, we determine that the level of skill in the art relevant to the claims of the ’356 patent is not limited to knowledge of and experience with conducting research relating to oncology or developing and conducting clinical trials, but includes knowledge of and experience with treating cancer patients with immunotherapy compounds, identifying the conditions these patients may have, and understanding the literature regarding clinical trials for such colorectal cancers and the associated conditions and immunotherapy.” slip op. at 9

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

      “The parties do not assert constructions of any terms recited in the challenged claims other than that their ordinary and customary meanings should apply. Pet. 10–11; PO Resp. 6. We determine that no express construction of any claim term is necessary to resolve the dispute between the parties. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We construe claims “in accordance with the ordinary and customary meaning of such history pertaining to the patent.” 37 C.F.R. § 42.100(b) (2020).” slip op. at 8

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency foundUnpatentable

      “(“the claimed process here is not directed to a new use; it is the same use, and it consists of the same steps as described by [the prior art]. Newly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.”). After analysis of the full record, we are persuaded that the results recited in claim 1 would follow from the steps taught in the MSR, for the reasons and based on the evidence Petitioner cites above. For these same reasons, we are unpersuaded by Patent Owner’s argument that it was unknown whether the amount of pembrolizumab recited in claim 1 would be effective in producing an improved outcome compared to a reference patient without a tumor that was not MSI-H or dMMR, and Patent Owner does not dispute that the amount of pembrolizumab disclosed in the MSR (10 mg/kg every 14 days; see Ex. 1005, 4) is the same as the amount provided in the ’356 patent as being effective (10 mg/kg every 14 days; Ex. 1001, 8:48–52, 13:50–52). Regardless of the inventors’ intent in publishing the MSR as a Stage II clinical trial on the www.clinicaltrials.gov website, as discussed above, we determine that the MSR teaches selecting a patient with a metastatic MSI-H or dMMR tumor and administering an amount of pembrolizumab that would be effective. See, e.g., Ex. 1005, 4 (Arms and Interventions). The result of drug treatment inherently follows its administration. The MSR does not merely suggest that pembrolizumab may be useful in some unidentified subset of patients or suggest that some unidentified drug may be useful for MSI-H cancer patients. Instead, the MSR discloses selecting a patient with a condition recited in claim 1 and treating with the drug at the amount recited in claim 1. Contra Metabolite Labs. Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1367 (Fed. Cir. 2004) (holding that the prior art did not” slip op. at 22

    Patent outcomesUS 10,934,356 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 10,934,356
  • PTAB · Oct 1, 2025 · IPR2024-00506 · APJ Justin T Arbes · IPR · Final written decision

    Claims 1, 2, 4–12, and 14–18 are unpatentable as obvious over the combinations of prior art listed in the decision.

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

      “d) Conclusion Petitioner has shown sufficiently that Weyman and Li collectively” slip op. at 50

    Patent outcomesUS 8,014,394 unpatentable
    § 103 obviousnesscites KSR · Graham
    Patents in suitUS 8,014,394
  • PTAB · Sep 30, 2025 · IPR2021-00375 · APJ Kristen L Droesch · IPR · Remand

    Proposed substitute claims 44–47, 49, and 50 are unpatentable as obvious under collateral estoppel; the Board denied Patent Owner’s motion to amend.

    RulingsRemand decision
    • RemandOther

      “the Acting Director of the USPTO (Paper 81, “Acting Director’s Order”) and after a decision by the U.S. Court of Appeals for the Federal Circuit (“the Federal Circuit”) in ZyXEL Communications Corp. v. UNM Rainforest Innovations, 107 F.4th 1368 (Fed. Cir. 2024) (“Federal Circuit Decision”) regarding the Board’s original Final Written Decision (Paper 68, “Final Written Decision” or “Final Dec.”) in this proceeding. In particular, the court remanded to the Board to determine if proposed substitute claims 44–47, 49, and 50 are unpatentable as obvious under collateral estoppel based on the court’s holding that claims 1–4 and 6–8 are unpatentable as obvious. ZyXEL, 107 F.4th at 1371, 1384.” slip op. at 2

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

      “proposed substitute claim 44 presents the same issues as those litigated before the Federal Circuit: whether it would have been obvious to a person of ordinary skill in the art to include the first key element and whether it would have been obvious to a person of ordinary skill in the art to include the second key element.” slip op. at 9

    • PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, deniedDenied

      “Final Written Decision, and the Federal Circuit Decision, as well as the postremand briefing, we determine that the application of collateral estoppel to proposed substitute claim 44 is appropriate. It is also appropriate to apply collateral estoppel to substitute claims 45–47, 49, and 50. This is because proposed substitute claims 45–47, 49, and 50 depend from proposed substitute claim 44 and recite identical limitations to dependent claims 2–4, 6, and 7. Therefore, the resolution of the question of obviousness of the subject matter of proposed substitute claims 45–47, 49, and 50 necessarily presents the same issues of whether it would have been obvious to a person of ordinary skill in the art to include the first key element and whether it would have been obvious to a person of ordinary skill in the art to include the second key element.” slip op. at 11

    Patent outcomesUS 8,265,096 unpatentable
    § 103 obviousness
    Patents in suitUS 8,265,096
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