• Early Warning Services, LLC v. Intellectual Ventures II LLCNo claims unpatentable
  PTAB · Feb 11, 2026 · IPR2024-01221 · APJ Iftikhar Ahmed · IPR · Final written decision

  Petitioner failed to prove claims 1, 2, 4, 5, 7, 8, 12, 13, 17, 19–21, 23, 24, 26, 27, 29, 30, 34, 39–41, and 43 unpatentable because the cited grounds did not establish the required …

  RulingsFinal written decision

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

    “image capture device” refers to an imaging-based barcode reader and not a laser-based barcode scanner because we are persuaded that claim language and Specification support that interpretation and also because Patent Owner persuasively shows that a person of ordinary skill in the art would have understood the term as such. Claim 1 recites an “image capture device configured to capture an image.” Ex. 1001, 16:24–25. The plain meaning of the claim term requires that the image be captured, not just scanned. The claim further requires “generating an output based on the information embedded in the image,” requiring that information is retrieved from the captured image. Id. at 16:32–33. A device that does not capture an image is not an “image capture device” under the plain language of the claim. A laser-based barcode scanner employs light reflected from a laser beam to “generate an electrical signal that corresponds to the bars and spaces in the barcode being scanned.” See Ex. 2029 ¶¶ 42–43 (explaining in detail how laser-based barcode self-emitting a laser light across a code to be scanned, with a sensor tuned to capture the reflected light from the laser.”). It simply does not capture an image. slip op. at 14

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Based on our review of the complete record, we determine that Petitioner’s stated level of ordinary skill in the art is reasonable because it is consistent with the evidence of record, including the asserted prior art. The field of the ’167 patent “relates generally to secure transactions, and more specifically, to methods and devices for providing secure identification, verification, and authorization using a portable secure device.” Ex. 1001, 1:8–11. The ’167 patent seeks “to provide methods and devices that are capable of providing secure transactions in a more efficient manner.” Id. at 3:11–13. Accordingly, we adopt Petitioner’s definition. We note, however, that our patentability analysis would be the same under Patent Owner’s definition.” slip op. at 11

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

    “We agree with Patent Owner that Wang fails to disclose limitation 1[a]. Wang discloses a portable electronic authorization device (PEAD) that can be used as a self-checkout terminal. Ex. 1004 ¶ 115. In this context, Wang discloses By entering the UPC code or barcode using keypad on the PEAD or scanning in the UPC code or barcode using the input device built into the PEAD such as a barcode scanner or OCR reader, the PEAD can generate the receipt with the list of item prices through the wireless network and Internet by querying the item price using the barcode as the index for price lookup table which is Stored in a Server System. Id. (emphasis added). As discussed above (Section III.C.1), we are persuaded by Patent Owner’s arguments that the claimed “image capture device” refers to an imaging-based device and not a laser-based barcode scanner. Petitioner does not contend that Wang’s disclosure of the barcode scanner necessarily refers to an imaging-based device, but argues that Wang’s disclosure is sufficient because “both imaging-based barcode scanners and laser-based barcode scanners constitute image capture devices.” Reply 11. In light of our claim construction above, we disagree.” slip op. at 27

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

    “Petitioner contends that claims 1, 4, 5, 7, 12, 17, 23, 26, 27, 29, 34, and 43 are unpatentable as obvious over the combination of Wang and Drummond. Pet. 30–43. 1. Drummond Drummond is a patent titled “Automated Banking Machine System and Method,” and “relates to an automated banking machine apparatus and system that are capable of use in a wide area network, and which provides a user with a remote electronic receipt or other record related to a transaction performed at the machine.” Ex. 1008, code (54), ¶ 2. Drummond discloses that its automated banking machine, may “initiate the sending of a non-paper transaction receipt to the customer,” “[t]he receipt may be sent using a wide area network, such as the Internet,” and “[t]he receipt may be an electronic receipt, for example a receipt in the form of an e-mail message.” Id. ¶ 247. 2. Claims 1, 4, 5, 7, 12, 17, 23, 26, 27, 29, 34, and 43 For this obviousness ground, Petitioner relies on the same arguments and evidence as its Ground 1a (anticipation by Wang), discussed above, for the majority of claim limitations. See Pet. 33–43. Importantly, Petitioner relies solely on Wang as teaching independent claim limitations [1a], [23a], and [43b] relating to an image capture device and embedded information. Pet. 36, 41, 43. Accordingly, for the reasons discussed above with respect to Ground 1a, Petitioner has not established by a preponderance of the evidence, that the subject matter of claims 1, 4, 5, 7, 12, 17, 23, 26, 27, 29, 34, and 43 would have been obvious to one of ordinary skill in the art over the combination of Wang and Drummond.” slip op. at 31

  Patent outcomesUS 7,314,167 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 7,314,167
• Luxottica Of America Inc. v. E-Vision Optics, LLCSome claims unpatentable
  PTAB · Dec 23, 2025 · IPR2024-01030 · APJ Richard H Marschall · IPR · Final written decision

  Claims 1–20, 22–31, and 33–37 are unpatentable; claims 21 and 32 were not shown unpatentable, principally because the proposed combinations failed to establish motivation to combine or the required airtight seal.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “We find that the proposals from the parties substantially overlap, such that it remains unclear whether any substantive difference exists. Notably, neither party argues that the minor differences in the proposals lead to a different outcome on any issues in this proceeding. Based on our review of the proposals, we apply Patent Owner’s proposal because it is consistent with the problems and solutions disclosed in the ’483 patent and prior art of record. See, e.g., GPAC, 57 F.3d at 1579 (approving the determination of the level of ordinary skill in the art by appeal to the references of record). The outcome of the issues addressed in this Decision would not change if we applied Petitioner’s proposal.” slip op. at 9

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

    “hermetically sealed” module does not encompass waterproof modules that are not airtight. First, as Petitioner admits, as a general matter, “[s]omething that is hermetically sealed is sealed so as to be airtight.” Pet. 28 (citing Ex. 1002 ¶ 103; Ex. 1010, 269); PO Sur-reply 16. Petitioner later tries to argue that the specification puts a different spin on this meaning, but still acknowledges that “[o]utside the context of the ’483 patent, a hermetic seal is sometimes equated with an airtight seal.” See Pet. Post-hearing 2–3 (citing Ex. 1002 ¶ 103; Ex. 1010, 269). Based on our review of the record, the “ordinary meaning” of “hermetically sealed” means “airtight,” and, as noted above, “airtight” is not the same thing as “waterproof.” Second, the claims support Patent Owner’s position by including dependent claims that separately claim a “hermetically sealed” module (claims 13 and 32) and a “waterproof” module (claims 15 and 34), strongly suggesting that the terms have a different scope to avoid rendering some claims redundant. See Ex. 1001, 11: 65–66, 12:3–4, 12:52–53, 12:55–56. Petitioner argues in its Post-hearing brief that claims requiring waterproof modules are “a narrower species” of hermetic seal, but fails to explain how hermetic, airtight, and waterproof seals would not fall within the scope of both claims using its approach. Pet. Post-hearing Reply 2. Petitioner’s earlier argument in its Reply also seems to cut against this position by asserting that the specification “treats hermitically sealing as conventional and equivalent to waterproofing,” with different dependent claims directed to two allegedly “equivalent” terms making little sense. Pet. Reply 14 (emphasis added). The most natural reading of the claim language suggests that “hermetically sealed” means airtight, and does not encompass modules that are waterproof but not airtight. Third, while the specification does not define “hermetically sealed” and uses “waterproof” and “hermetically sealed” in similar contexts, it does not suggest that “hermetically sealed” does not require an airtight seal consistent with its ordinary meaning. See Pet. Reply 14–15 (citing Ex. 1001, 6:47–53, 9:15–18, 10:47–50). Instead, the specification states that hermetic seals prevent water from contacting electronics, which remains consistent with Patent Owner’s position because airtight hermetic seals are also waterproof. See Ex. 1001, 6:47–53, 9:15–18. The specification also states that “[t]he module preferably houses any of the aforementioned electrical components in a substantially water-proof and wear resistant/moisture resistant environment and is preferably hermetically sealed.” Id. at 10:47–50 (emphasis added). This passage supports Patent Owner’s position by suggesting that the preferable “hermetically sealed” module goes beyond mere water resistance. See PO Sur-reply 16–17. slip op. at 16

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

    “2. Petitioner’s Anticipation Arguments and Evidence Petitioner argues that Howell-596 discloses every limitation of claims 1, 9, 10, 14, 15, and 18, and points to specific portions of Howell-596 and expert testimony to support its arguments. See Pet. 10–20 (citing Ex. 1002; Ex. 1003). We have reviewed the evidence and arguments of record and find that Petitioner has shown, by a preponderance of the evidence, that the limitations in claims 1, 9, 10, 14, 15, and 18 are disclosed by Howell-596 for the reasons set forth in the Petition, which we adopt as our own. See id.11 Accordingly, we find that Petitioner has established, by a preponderance of the evidence, that Howell-596 anticipates claims 1, 9, 10, 14, 15, and 18.” slip op. at 12

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentableNot shown unpatentable

    “Based on these undisputed points and the parties’ arguments, we agree with Patent Owner that Petitioner fails to establish that a POSITA would have been motivated to locate Howell-596’s module housing 1700, which contains its UV detection system 1500, behind a user’s ear. Petitioner never squarely addresses the fact that placing Howell-596’s UV detection system behind a user’s ear would negatively impact its performance. Pet. 31–33; Pet. Reply 17–22. As a result, even if we accept Petitioner’s arguments and evidence as to the various advantages when placing electronics behind a user’s ear, it fails to establish a motivation to combine that requires placing Howell-596’s module housing 1700, and therefore its UV detection system, behind a user’s ear. Petitioner never acknowledges the readily apparent disadvantages of placing a UV detection system behind the ear, where it may not work at all. See Pet. 31–33. Nor does Petitioner argue that, in its combination, adjustments would be made to ensure accurate operation of Howell-596’s UV detection system. See id. Similarly, Petitioner notes that both Howell-596 and Howell-833 disclose UV sensors behind the ear of a user, but those teachings do not establish that placing Howell-596’s module behind the ear would ensure proper operation of its UV detection system housed within that module. See Pet. Reply 17–22. Instead, even though Howell-596 discloses a sensor behind the ear of a user, it maintains the UV detection system in a module toward the front of the temple, away from the ear. See id. at 18–19; PO Surreply 21–22; Ex. 1003 ¶ 205 (describing UV detection system 2102), Fig. 21 (showing UV detection system 2102 toward the front of the temple). Moreover, Petitioner’s reliance on the sensor placed behind the ear of the user in Howell-596 lacks weight because that sensor merely indicates that the device “is being worn by a user,” which serves a very different purpose than Howell-596’s UV detection system, which seeks to monitor a user’s exposure to UV radiation, a central purpose of Howell-596’s eyewear. See Ex. 1003 ¶ 205, code (57). Howell-833 also employs a UV sensor behind the ear, but Petitioner does not establish that it operates any differently than the “being worn” sensor in Howell-596, and therefore does not establish that Howell-596’s UV detection system would still work for its intended purposes in Petitioner’s proposed combination. See Pet. Reply 19–20.” slip op. at 29

  Patent outcomesUS 8,708,483 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR
  Patents in suitUS 8,708,483
• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  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
• Apple Inc. v. Apex Beam Technologies LLCInstituted
  PTAB · Nov 14, 2025 · IPR2025-00907 · APJ Justin T Arbes · IPR · Institution

  The Board instituted IPR on claims 1–20 and all asserted grounds after finding a reasonable likelihood that claim 1 is unpatentable over the three 3GPP references.

  RulingsInstitution decision

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

    “inter partes review unless the information in the petition and preliminary 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.” See 37 C.F.R. § 42.4(a) (“The Board institutes the trial on behalf of the Director.”). For the reasons that follow, we institute an inter partes review as to claims 1–20 of the ’944 patent on all grounds of unpatentability asserted in the Petition.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “B. Level of Ordinary Skill in the Art Petitioner argues that at the time of the ’944 patent (November 2019),2 a person of ordinary skill in the art would have had “a bachelor’s degree in electrical engineering, computer engineering, computer science, or a similar field, along with two years of experience designing or developing wireless networks, including long-term evolution LTE/4G or 5G new radio (NR) cellular technology,” where “[a]dditional years of experience could substitute for an advanced-level degree (and vice versa).” Pet. 10 (citing Ex. 1003 ¶¶ 39–44). Patent Owner “utilizes Petitioner’s proposed level of skill in the art” for its Preliminary Response. Prelim. Resp. 8. Based on the record presented, including our review of the ’944 patent and the types of problems and solutions described in the ’944 patent and cited prior art, we agree with Petitioner’s proposed definition of the level of ordinary skill in the art and apply it for purposes of this Decision.” slip op. at 10

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

    “C. Claim Interpretation We interpret each challenged claim using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. 282(b), including construing the claim in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent. 37 C.F.R. § 42.100(b). Petitioner argues that “no claim terms need be construed.” Pet. 8. Patent Owner does not propose interpretations of any claim terms in its Preliminary Response. We conclude that no express interpretation of any claim term is necessary to determine whether to institute an inter partes review in this proceeding, but encourage the parties to address various claim interpretation issues identified below during trial. See infra Section II.D.5; 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 11

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

    “Patent Owner responds that Petitioner fails to show that the 3GPP-38.213-CR “document sent to [the] 3GPP email list on November 3 was available to non-3GPP members by November 5, 2019” (the alleged critical date for the ’944 patent). Prelim. Resp. 3 (emphasis omitted); see Pet. 10. According to Patent Owner, the listserv archive of emails cited by Mr. Rodermund “only shows that the November 3, 2019 email is available now—not that it was uploaded within a day of when the original email was sent”—and Mr. Rodermund provides only his uncorroborated opinion that uploads were “automatic” and “immediate.” Prelim. Resp. 5–6 (citing Ex. 1008 ¶¶ 43–63, 72–80). Patent Owner also contends that the November 2, 2019, metadata only relates to creation of 3GPP-38.213-CR and does not support Petitioner’s contention that the email was immediately uploaded. Id. at 6. Finally, Patent Owner argues that whether the subject matter of 3GPP-38.213-CR was discussed at the 3GPP meeting in October 2019 is “irrelevant,” given the date of the metadata, and has no bearing on whether the document itself was later publicly accessible. Id. at 6–7. Assessing the evidence of record collectively, however, we are persuaded that Petitioner has shown a reasonable likelihood that 3GPP-38.213-CR was publicly accessible from the ETSI email archive before November 5, 2019. Given his many years of experience with ETSI, in particular his responsibilities pertaining to management of documents like change requests, and as the “list owner” “responsible for managing and administrating” several email exploder lists, Mr. Rodermund appears to be well-qualified to testify to the matters in his declaration. See Ex. 1008 ¶¶ 7, 10–15, 47. He explains in detail how, based on his experience, emails sent” slip op. at 20

  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,139,944
• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  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
• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  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
• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  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
• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  PTAB · Sep 23, 2025 · IPR2024-00649 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 1–28 are unpatentable: claims 1, 2, 4–7, 9–12, 14–17, and 19–28 are anticipated by the MSI-H Study Record; claims 3, 8, 13, and 18 are obvious.

  RulingsFinal written decision

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

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

  • Skill levelSkill level board ownOther

    “In the Decision to institute trial, we adopted Petitioner’s uncontested proposal defining that the level of skill in the art, presented above. Inst. Dec. 7. Neither party directs us to evidence of the level of skill in the art beyond what we considered for institution of trial. Having considered Patent Owner’s positions and evidence of record, however, we determine that the level of skill also includes knowledge of and experience with treating cancer patients with immunotherapy compounds, identifying the conditions these patients may have, and understanding the literature regarding clinical trials for such cancers and the associated conditions and immunotherapy.” slip op. at 15

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

    “holding is limited to anticipation of a claimed genus through disclosure of individual species, whereas the facts of this case involve the disclosure of a genus. PO Resp. 14. Because the facts before us, including the testimony of Patent Owner’s witness, indicate that one of ordinary skill in the art would have immediately understood that the third arm of the study described in the MSR includes patients with cancers recited in claim 1, including endometrial, gastric, and small-bowel cancers, we are persuaded that one of ordinary skill in the art would have understood that the MSR discloses species that fall within the scope of claim 1. Ex. 2090 ¶ 79; Ex. 1243, 115:5–116:22; Ex. 1085, 673–75; Ex. 1086, 14; Ex. 1003 ¶¶ 25, 63; Ex. 1005, 4. We are not persuaded that where species falling within the scope of claim 1 were previously known and disclosed in MSR, that claim 1 is patentable over the MSR. See Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381 (Fed. Cir. 2015) (“a reference can anticipate a claim even if it ‘d[oes] not expressly spell out’ all the limitations arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’” the claimed arrangement or combination.” (quoting In re Petering, 301 F.2d 676, 681 (CCPA 1962)). After considering the parties’ arguments and the evidence presented, we are persuaded that the MSR teaches “testing or having tested a biological sample obtained from a patient” having endometrial, small bowel, or gastric cancer and, thus teaches the corresponding limitation of claim 1.6” slip op. at 29

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

    “Regarding the dependent claims that Petitioner challenges only on obviousness grounds (claims 3, 8, 13, 18), Patent Owner must show a nexus between the claimed methods and the evidence of non-obviousness. See Henny Penny Corp. v. Frymaster LLC, 938 F.3d 1324, 1332 (Fed. Cir. 2019) (“to be accorded substantial weight in the obviousness analysis, the evidence of secondary considerations must have a ‘nexus’ to the claims, i.e., there must be ‘a legally and factually sufficient connection’ between the evidence and the patented invention. . . . Ultimately, ‘[t]he patentee bears the burden of showing that a nexus exists.’” (quoting Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387, 1392 (Fed. Cir. 1988), WMS Gaming, Inc. v. Int'l Game Tech., 184 F.3d 1339, 1359 (Fed. Cir. 1999)). Patent Owner does not direct us to evidence of a nexus to limitations recited in the dependent claims, for example to claims 3 and 13, which recite testing a biological sample that is a bodily fluid, claims 8 and 18, which recite testing that comprises assessing one or more markers selected from the group consisting of BAT-25, BAT-26, MONO-27, NR-21 and NR-24. Even if there is a nexus to the Patent Owner’s evidence of secondary considerations, the evidence addresses the methods of independent claims 1 and 11, not the limitations of the claims Petitioner challenges as being obvious. PO Resp. 55–83. Patent Owner directs us only to evidence regarding treating patients determined to have certain MSI-H cancers with pembrolizumab, which we determine to be anticipated by the MSR. Id. at 58. When evidence of a “secondary consideration is exclusively related to a single feature that is in the prior art,” our reviewing court has held the evidence is of no relevance to the obviousness inquiry. See Yita LLC v. MacNeil IP LLC, 69 F.4th 1356, 1363–65 (Fed. Cir. 2023), cert. denied, 144 S. Ct. 499 (2023) (distinguishing WBIP, LLC v. Kohler Co., 829 F.3d 1317, 1330–31 (Fed. Cir. 2016)); see also Ethicon Endo-Surgery, Inc. v. Covidien LP, 812 F.3d 1023, 1034 (Fed. Cir. 2016) (“[I]f the feature that creates the commercial success was known in the prior art, the success is not pertinent.”). In Yita, the prior art taught close-conformance of a floor tray with the walls of a vehicle foot well, which one of ordinary skill in the art would have had reason to use in combination with other prior-art teachings to arrive at the claimed invention. See Yita, 69 F.4th at 1359–61. The court held that because the asserted evidence of secondary consideration related exclusively to close-conformity, the evidence was not persuasive of non-obviousness, even though the claimed floor tray was coextensive with the product that produced the evidence. See id. at 1364–65 (“The coextensiveness inquiry bears only on the presumption of nexus; it does not decide the overall nexus question.”). Because Patent Owner directs us only to evidence that the methods recited in claims 1 and 11 produced evidence of secondary considerations, we are not persuaded that this evidence is persuasive of the non-obviousness of the specific methods recited in the dependent claims. For example, Patent Owner fails to direct us to evidence that a method of treating MSI-H colorectal cancer in a patient “wherein the biological sample is a body fluid from the patient,” as recited in claim 3, or “wherein the at least one marker comprises BAT-25, BAT-26, MONO-27, NR-21 or NR-24,” as recited in claim 8, demonstrated unexpected results or commercial success. Accordingly, having considered the evidence of record as a whole, we determine that Petitioner has demonstrated by a preponderance of the evidence that the methods of claims 3, 8, 13, and 18 would have been obvious. We are not persuaded to the contrary by Patent Owner’s arguments or evidence of second secondary considerations.” slip op. at 47

  Patent outcomesUS 11,629,187 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,629,187
• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  PTAB · Sep 23, 2025 · IPR2024-00647 · APJ Sheridan K Snedden · IPR · Final written decision

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

  RulingsFinal written decision

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

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

  • Skill levelSkill level petitioner adoptedDecided for petitioner

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

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

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

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

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

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

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

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

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

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

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

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

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

  Patent outcomesUS 11,634,491 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,634,491

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.