• Mercedes-Benz Group AG v. The Phelan Group, LLCInstituted
  PTAB · Nov 21, 2025 · IPR2025-00919 · APJ Mitchell G Weatherly · IPR · Institution

  The Board instituted IPR of claims 1–20 on all asserted grounds, finding a reasonable likelihood that Murphy renders claim 1 obvious.

  RulingsInstitution decision

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

    “Preliminary Response. Therefore, Petitioner’s arguments for unpatentability are currently unopposed. Institution of an inter partes review is authorized by statute when “the information presented in the petition filed under section 311 and any response filed under section 313 shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Based on our review of the record, we conclude that Petitioner is reasonably likely to prevail with respect to at least one challenged claim.” slip op. at 2

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

    “information processing facility”) to control the operation of the vehicle. Id. at 15–17 (citing Ex. 1006, 2:20–53, 4:15–27, 5:13–60, 6:1–18, 7:49–9:44, 10:29–40, 10:45–11:27, 12:6–27, 13:66–14:17, 14:23–45, 15:9–54, 16:12–50, 17:30–63, Figs. 2, 3, 6, 7, claims 1–3, 7, 9, 12, 15, 18, code (57); Ex. 1004 ¶¶ 65–77). Petitioner also argues that it would have been obvious to modify Murphy’s vehicle interface module to monitor operation of the vehicle for violations and transmit a signal to the master control unit. Id. at 17–19 (citing Ex. 1006, 1:66–2:53, 5:29–60, 7:49–9:44, 10:29–40, 10:45– 11:27, 12:1–15, 13:28–43, 13:53–14:22, 15:9–16:11, 16:50–17:63, code (57), Figs. 2, 3, 6, 7, claims 1, 10; Ex. 1004 ¶¶ 74–77). Petitioner contends that the modification would have involved a “simple substitution of one existing component (e.g., controller) for another (e.g., vehicle interface module) to perform the same functionality. This substitution would have had predictable results: the system would determine whether the driver has violated her profile regardless of which component is used.” Id. at 18 (citing Ex. 1004 ¶¶ 74–77) (internal citations omitted). The modification would reduce the communication and computation burden on Murphy’s controller. Id. at 19. Patent Owner does not contest Petitioner’s showing. Based on our review of Petitioner’s argument and the evidence that Petitioner cites in support, we find that Petitioner has demonstrated a reasonable likelihood of proving that Murphy describes the subject matter of limitation 1D. slip op. at 10

  § 103 obviousnesscites Phillips · KSR
  Patents in suitUS 10,259,465
• 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
• Google LLC v. Sandpiper CDN, LLCInstituted
  PTAB · Nov 10, 2025 · IPR2025-00806 · APJ Sheila F Mcshane · IPR · Institution

  The Board instituted IPR on claims 1–20 and all asserted grounds, finding a reasonable likelihood of success on the § 103 challenges.

  RulingsInstitution decision

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

    “partes review. See 35 U.S.C. § 314; 37 C.F.R. § 42.4(a). Under 35 U.S.C. § 314(a), we may not authorize an inter partes review unless the information in the petition and the 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.” For the reasons stated below, we determine that Petitioner has established a reasonable likelihood that it would prevail with respect to at least one claim. We therefore institute inter partes review as to all of the challenged claims of the ’517 patent and all of the asserted grounds of unpatentability in the Petition.” slip op. at 2

  • Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner

    “application must comply with the written description requirement of 35 U.S.C. § 112.” Zenon Envtl., Inc. v. U.S. Filter Corp., 506 F.3d 1370, 1378 (Fed. Cir. 2007) (quoting Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1571 (Fed. Cir. 1997)); see also In re Hogan, 559 F.2d 595, 609 (CCPA 1977). To comply with the “written description” requirement of 35 U.S.C. § 112, first paragraph, an applicant must “convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563–64 (Fed. Cir. 1991) (emphasis omitted). The invention claimed does not have to be described in ipsis verbis to satisfy the written description requirement. Union Oil Co. v. Atlantic Richfield Co., 208 F.3d 989, 1000 (Fed. Cir. 2000). The question of written description support should not be confused, however, with the question of what would have been obvious to the artisan. Whether one skilled in the art would find the claimed invention obvious in view of the disclosure is not an issue in the “written description” inquiry. In re Barker, 559 F.2d 588, 593 (CCPA 1977). “A description which renders obvious the invention for which an earlier filing date is sought is not sufficient.” Lockwood, 107 F.3d at 1572.” slip op. at 11

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

    “motivated to combine Beaumont and Hasan. Pet. 13–14. Petitioner argues that “Beaumont does not describe a specific interface for manually entering [policy and rules] preferences, Hasan discloses a GUI for exactly this type of policy specification.” Id. at 14 (citing Ex. 1003 ¶ 70). Petitioner asserts that Hasan discloses that its Java-based, “platform independent” GUI takes the form of a “familiar tree structure” and allows administrators to “configure device and service configuration data and policy information.” Id. (citing Ex. 1006, code (57), 7:7–26, 8:19–29, 18:9–20). Petitioner asserts that the combination of Beaumont and Hasan would have been straightforward, and a person of skill “would have been motivated to incorporate Hasan’s GUI so that administrators could conveniently configure preferences for Beaumont’s DNS servers through an intuitive interface.” Id. (citing, inter alia, Ex. 1003 ¶¶ 70–71; Ex. 1007 ¶ 23). Patent Owner does not present any arguments on the rationale to combine. See generally Prelim. Resp. We find that at this juncture Petitioner has presented sufficient rationale to combine Beaumont and Hasan.” slip op. at 16

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

    “We agree with Patent Owner that its understanding of a policy as a rule is consistent with the disclosure in the ’517 patent that “a policy may be created by generating a decision tree representing the ATC rules.” See Ex. 1001, 9:1–3. We do not agree with Patent Owner, however, that Beaumont in combination with Hasan does not disclose the claimed policy features as claimed. As discussed above, Petitioner relies upon Beaumont in combination with Hasan with its teachings on the use of Java-based GUIs in the form of a tree structure that allows administrators to configure device and service configuration data, as well as policy information. See Ex. 1006, code (57), 7:7–26, 8:19–29. For the policy teachings, Petitioner relies upon Beaumont’s “content provider DNS server that directs requests (traffic) according to a preference table (policy).” Pet. 15–16 (citing Fig. 1, ¶¶ 6, 17, 23). Petitioner also asserts that the Beaumont-Hasan GUI would enable an administrator to set policies for a selected content delivery server to allow setting server preferences and rules. Id. at 17–18 (citing, inter alia, Ex. 1007 ¶¶ 76–77). In support, Dr. Lin testifies that: The Beaumont-Hasan GUI would enable an administrator to select a content delivery server (e.g., in Japan) and set policies for that server. Hasan, 8:30–36, 10:25–34, 10:53–67; Beaumont, [0031]. For example, given the description in Hasan, selecting a server would bring up a menu enabling an administrator to assign the preferences shown in Fig. 3 of Beaumont. Hasan, 10:25–34; Beaumont, Figs. 2, 3, [0029]–[0031]. A POSITA would thus have recognized the combined GUI to “support[] the setting of said at least one policy using a decision tree representing rules” because it is presented in a “familiar tree structure” and would allow users to set server preferences and rules. Ex. 1003 ¶ 77 (emphasis added). Beaumont provides support for Dr. Lin’s testimony. Beaumont discloses that “rules such as selecting one [a server] based on user preferences can be used . . . [f]or example, a preference number can be assigned to each content delivery server and a destination domain.” Ex. 1007 ¶ 31. Beaumont further states that “FIG. 3 shows an illustrative example of incorporating preference numbers in a column.” Id. Thus, contrary to Patent Owner’s arguments, Beaumont discloses that rules or policies, represented by the preference number, are represented in the table shown in Figure 3 of Beaumont. Dr. Lin also testifies that in the Beaumont-Hasan combination “the GUI supports the setting of” policy is taught. Ex. 1003 ¶ 77. Hasan provides support that service policies can be modified by the use of a GUI. See Ex. 1006, 8:30–36, 10:25–34, 10:53–67. Accordingly, in the combination of Beaumont and Hasan, wherein the preference database is replaced by the GUI decision tree, Petitioner has provided sufficient evidence at this juncture that the combination of Beaumont and Hasan teaches that the GUI obtains a policy, the preference number, for the direction of network traffic, where the GUI supports the setting of the policy using a decision tree representing rules.” slip op. at 19

  Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 8,645,517
• Google LLC v. Sandpiper CDN, LLCInstituted
  PTAB · Nov 7, 2025 · IPR2025-00826 · APJ Michael T Cygan · IPR · Institution

  The Board instituted IPR on all asserted grounds for claims 1–23, finding a reasonable likelihood of obviousness for claims 13–22 over Glines and Gupta.

  RulingsInstitution decision

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

    “review. See 35 U.S.C. § 314 (2018); 37 C.F.R. § 42.4(a) (2023). The standard for instituting an inter partes review is set forth in 35 U.S.C. § 314(a), which provides that an inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” For the reasons given below, on this record, Petitioner has established a reasonable likelihood that it would prevail in showing the unpatentability of at least one of challenged claims 1–23 of the ’112 patent. Accordingly, we institute an inter partes review of the ’112 patent.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner asserts that a person of ordinary skill in the art (“POSITA”) at the critical time “would have had at least a bachelor’s degree in computer science, electrical engineering, or a related field, and at least two years of work or research experience in the field of content delivery management or networks,” and that “additional education could substitute for work experience.” Pet. 3 (citing Ex. 1008 ¶¶ 51–53). Patent Owner does not provide any such assessment in its Preliminary Response. Prelim. Resp. 11. For purposes of this Decision, we adopt Petitioner’s proposed level of ordinary skill, as it appears to be consistent with the specification of the ’112 patent and the prior art of record.” slip op. at 7

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

    “claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. [§] 282(b).” 37 C.F.R. § 42.100(b). Under this standard, the words of a claim generally are given their “ordinary and customary meaning,” which is the meaning the term would have to a person of ordinary skill at the time of the invention, in the context of the entire patent including the specification. Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Neither party proposes any express claim construction at this stage of the proceeding. Pet. 3; Prelim. Resp. 12. Based on the record before us, we determine that no claim term requires express construction for purposes of this Decision.” slip op. at 8

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “Dr. Mowry further attests that “A POSITA would have understood Glines’s disclosure of providing content from an origin source would have included supporting more than one origin source (e.g., more than one website or content provider[)].” Ex. 1008 ¶ 262 (citing Ex. 1002, 12:11–22 (storing replica files that originate at an origin server 40), 13:21–14:3 (requesting “example.com”)). That statement, however, goes only to what Glines might be capable of doing, not to whether one would have modified Glines to do so. See Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015) (“[o]bviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed inventions.”). Dr. “content providers” limitation, stating that it “would have been nothing more than replicating Glines’s teaching of storing and providing content associated with one origin server, with expected results.” Ex. 1008 ¶ 263. That statement, however, is unsupported, and moreover, does not explain how such replication would occur or what results would be expected. Prelim. Resp. 25–26. At this stage in the proceeding, Dr. Mowry’s testimony amounts to a “conclusory generalization” that does not provide the “reasoned explanation” sufficient to show that a limitation missing in the cited art was taught by the knowledge in the art. Arendi S.A.R.L v. Apple, Inc., 832 F.3d 1355, 1365 (Fed. Cir. 2016).” slip op. at 14

  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 9,021,112
• 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
• Toyota Motor Corp. v. Autoconnect Holdings LLCInstituted
  PTAB · Oct 16, 2025 · PGR2025-00041 · APJ Justin T Arbes · PGR · Institution

  The Board instituted PGR of claims 1–20 on all asserted grounds after finding claim 1 more likely than not obvious over Hendry.

  RulingsInstitution decision

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

    “a post-grant review unless the information in the petition, if unrebutted, “would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 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 a post-grant review as to claims 1–20 of the ’243 patent on all grounds of unpatentability asserted in the Petition.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “a person of ordinary skill in the art would have had “at least a bachelor’s degree in computer science, electrical engineering, or a related field, and two years’ experience in data management or client-server systems and communications,” where “a higher education or skill level might make up for less experience, and vice-versa.” Pet. 6 (citing Ex. 1003 ¶¶ 35–39). Patent Owner did not file a Preliminary Response disputing Petitioner’s position. Based on the record presented, including our review of the ’243 patent and the types of problems and solutions described in the ’243 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, except that we remove the term “at least” to eliminate vagueness as to the amount of education and practical experience.” slip op. at 10

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

    “any reasonable construction.” Pet. 7. Patent Owner did not file a Preliminary Response disputing Petitioner’s position. We conclude that no express interpretation of any claim term is necessary to determine whether to institute a post-grant review in this proceeding.4 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.’” (citation omitted) (emphasis added)). 4 The parties, however, are encouraged to address during trial (1) interpretation of the term “user profile” in the challenged claims, particularly in view of the Specification’s apparent definition of the term “profile” (see Ex. 1001, col. 14, ll. 51–55) and description of exemplary data from which a “user profile” may be generated (id. at col. 18, ll. 40–58), and (2) the scope of the various instances of the phrase “in response to” in the challenged claims. Also, if either party intends to argue a claim interpretation during trial, including what the plain and ordinary meaning of a term is, the party should do so in a clearly designated section of its briefing. See Patent Trial and Appeal Board Consolidated Trial Practice Guide (Nov. 2019), 44–49, available at https://www.uspto.gov/ TrialPracticeGuideConsolidated; O2 Micro Int’l Ltd. v. Beyond Innovation Tech. Co., 521 F.3d 1351, 1361 (Fed. Cir. 2008) (“A determination that a claim term ‘needs no construction’ or has the ‘plain and ordinary meaning’ may be inadequate when a term has more than one ‘ordinary’ meaning or when reliance on a term’s ‘ordinary’ meaning does not resolve the parties’ dispute.”).” slip op. at 11

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

    “each of its elements was, independently, known in the prior art.” KSR, 550 U.S. at 418. An obviousness determination based on a combination of references requires finding “both ‘that a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.’” Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367–68 (Fed. Cir. 2016) (quoting Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688 F.3d 1342, 1360 (Fed. Cir. 2012)); see also KSR, 550 U.S. at 418 (for an obviousness analysis, “it can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does”). Also, “[t]hough less common, in appropriate” slip op. at 8

  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 12,039,243
• Aroma360, LLC v. Air Esscentials, Inc.Instituted
  PTAB · Oct 8, 2025 · IPR2025-00705 · APJ Eric C Jeschke · IPR · Institution

  The Board instituted IPR on claims 7–9 and 11 on all asserted grounds after finding a reasonable likelihood of prevailing on at least one claim.

  RulingsInstitution decision

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

    “review. See 35 U.S.C. § 314; 37 C.F.R. § 42.4(a) (2024) (“The Board institutes the trial on behalf of the Director.”). Inter partes review may not be instituted “unless . . . the information presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314. Upon consideration of the evidence and arguments in the record, for the reasons below, we determine that the information presented shows a reasonable likelihood that Petitioner would prevail with respect to at least one of the challenged claims. We thus institute inter partes review on all challenged claims on all asserted grounds. See SAS Inst. Inc. v. Iancu, 584” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “(1) a bachelor’s degree in mechanical engineering, aerospace engineering, chemical engineering, or a similar engineering field, with at least two years of work experience in fluid dynamics or fluid systems engineering; or (2) a master’s degree in mechanical engineering, aerospace engineering, chemical engineering, or a similar engineering field, with at least one year of work experience in fluid dynamics or fluid systems engineering.” slip op. at 8

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

    “same claim construction standard that would be used in a civil action under 35 U.S.C. § 282(b), as described in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc). See 37 C.F.R. § 42.100(b). Under that standard, we generally give claim terms their ordinary and customary meaning, as would be understood by a person of ordinary skill in the art at the time of the invention, in light of the language of the claims, the specification, and the prosecution history. See Phillips, 415 F.3d at 1313–14. Although extrinsic evidence, when available, may also be useful when construing claim terms under this standard, extrinsic evidence should be considered in the context of the intrinsic evidence. See id. at 1317–19.” slip op. at 8

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

    “Although a final conclusion of obviousness must be supported by findings and analysis establishing a reason to combine or modify the known elements as proposed, the analysis “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). Patent Owner also argues that Petitioner “fails to explain how Zeng’s noise reduction head 20 and inner cover 30, designed for a different atomizer configuration, could be integrated into Sevy’s system without changing the principles of Sevy’s operation.” Prelim. Resp. 13–14; see also id. at 16 (arguing that “Zeng’s components are not mere drop-in replacements”). Although the relied-upon structures from Zeng are, of course, disclosed in that reference as part of another atomizer, “[t]he test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference.” In re Keller, 642 F.2d 413, 425 (CCPA 1981). “Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art.” Id. As to the alleged change in the principle of operation, Patent Owner has not adequately explained why Sevy’s principle of operation would change with the proposed combination, which replaces Sevy’s alleged “silencer assembly” with similar teachings of Zeng.” slip op. at 27

  Claim construction§ 103 obviousnesscites Phillips
  Patents in suitUS 9,527,094
• Aroma360, LLC v. Air Esscentials, Inc.Instituted
  PTAB · Oct 8, 2025 · IPR2025-00706 · APJ Eric C Jeschke · IPR · Institution

  The Board instituted inter partes review of claims 1, 4, and 7–10 on all asserted grounds, finding a reasonable likelihood of prevailing on at least one challenged claim.

  RulingsInstitution decision

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

    “review. See 35 U.S.C. § 314; 37 C.F.R. § 42.4(a) (2024) (“The Board institutes the trial on behalf of the Director.”). Inter partes review may not be instituted “unless . . . the information presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314. Upon consideration of the evidence and arguments in the record, for the reasons below, we determine that the information presented shows a reasonable likelihood that Petitioner would prevail with respect to at least one of the challenged claims. We thus institute inter partes review on all challenged claims on all asserted grounds. See SAS Inst. Inc. v. Iancu, 584 U.S. 357, 362–63, 369–70 (2018); 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”).” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “we view the prior art and the claimed invention. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). The person of ordinary skill in the art is a hypothetical person presumed to have known the relevant prior art. In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995). In determining the level of ordinary skill in the art, we may consider certain factors, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” Id. (internal quotation marks and citation omitted).” slip op. at 7

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

    “same claim construction standard that would be used in a civil action under 35 U.S.C. § 282(b), as described in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc). See 37 C.F.R. § 42.100(b). Under that standard, we generally give claim terms their ordinary and customary meaning, as would be understood by a person of ordinary skill in the art at the time of the invention, in light of the language of the claims, the specification, and the prosecution history. See Phillips, 415 F.3d at 1313–14. Although extrinsic evidence, when available, may also be useful when construing claim terms under this standard, extrinsic evidence should be considered in the context of the intrinsic evidence. See id. at 1317–19. Neither Petitioner nor Patent Owner propose explicit constructions for any claim terms. Pet. 12–13; see generally Prelim. Resp. At this stage of the proceeding and based on the current record, we need not construe explicitly any claim terms because doing so would not change the outcome of the analysis below. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those 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)).” slip op. at 8

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

    “On the current record, this argument does not identify a deficiency in Petitioner’s position as to clauses 1C and 1D. Patent Owner implies that the structures recited in clauses 1C and 1D require functionality recited elsewhere in the claim—namely, forming a “fluid dispersion” (Prelim. Resp. 4)—but Patent Owner does not adequately present evidence supporting this implied claim construction. See In re Self, 671 F.2d 1344, 1348 (CCPA 1982) (rejecting arguments “not based on limitations appearing in the claims”). Instead, Patent Owner cites to the entirety of claim 1 in support of these implied functional requirements. See Prelim. Resp. 4. Stated differently, Patent Owner has not adequately explained why any particular component (or collection of components) must perform the function of forming the “fluid dispersion” recited in clause 1G. Moreover, even assuming as correct Patent Owner’s assertion that Sevy “requires downstream separation,” Patent Owner has not explained why such a 8 In its Preliminary Response, Patent Owner appears to use different terms for the same concept: “downstream separation”; “post-formation correction”; and “post-atomization correction.” See, e.g., Prelim. Resp. 3 (“downstream separation”), 4 (“post-formation correction”), 5–6 (“post-atomization correction”). In any response, Patent Owner should clarify the scope of these terms. requirement would fall outside of the scope of claim 1. See Elbit Sys. of Am., LLC v. Thales Visionix, Inc., 881 F.3d 1354, 1359 (Fed. Cir. 2018) (“‘[A]ttorney argument is not evidence’ and cannot rebut other admitted evidence.” (quoting Icon Health & Fitness, Inc. v. Strava, Inc., 849 F.3d 1034, 1043 (Fed. Cir. 2017))). On the current record, we determine that Petitioner has made a sufficient showing that Sevy discloses or suggests the structures recited in clauses 1C and 1D.” slip op. at 14

  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips
  Patents in suitUS 10,583,449

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.