• Activision Blizzard, Inc. v. Milestone Entertainment, LLCAll claims unpatentable
  PTAB · Oct 8, 2026 · IPR2025-00711 · APJ Linda E Horner · IPR · Final written decision

  Claims 1, 2, 4–7, 9, 11–13, 15, 19, 23, 24, and 29 are unpatentable as obvious over Kelly, Kelly and Paulsen, or Walker and Schneier.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

    “B. Level of Ordinary Skill in the Art There is no evidentiary dispute about the level of ordinary skill in the art.7 Based on the testimony of Mr. Crevelt, we determine that a person of ordinary skill in the art would have had at least a bachelor’s degree in computer science or computer engineering, with at least three years of experience in game development. Pet. 12 (citing Ex. 1003 ¶¶ 100–103). Additional experience could substitute for less education, and additional education could likewise substitute for less experience. Id. We determine that the level of ordinary skill in the art adopted above is consistent with the level of technical understanding and competence reflected in the ’164 patent Specification and the asserted prior art references, based on our review of the record.” slip op. at 10

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

    “Petitioner argues that it is not necessary for the Board to provide an express construction for any claim term because the Petition “establishes the prior art meets each claim limitation under any reasonable construction.” Pet. 13. Patent Owner similarly submits that “[t]he Board need not construe any terms at this stage, because under any reasonable construction of the claim terms, the prior art fails to disclose or suggest the claimed features.” Resp. 8–9. Patent Owner notes, however that “it has relied on the plain meaning of ‘frequency of play’ in Claim 7.” Id. at 9. We agree that no explicit claim construction is necessary for this decision because, even were we to adopt Patent Owner’s proffered plain meaning of “frequency of play,” Petitioner has demonstrated that the prior art renders obvious this claim limitation. To the extent the parties’ arguments raise any implicit issues of claim construction, we address those issues within the context in which they are raised in our analysis below.” slip op. at 11

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

    “Patent Owner does not contest Petitioner’s showing that Kelly renders obvious the subject matter of claims 1, 2, 4–6, 11–13, 15, 19, 23, 24, and 29. Resp., passim; Tr. 50:4–13.8 We have reviewed Petitioner’s arguments and 8 Patent Owner argued in its Preliminary Response that Kelly does not disclose limitations [1.c.iii] and [1.c.v]. Prelim. Resp. 10–12. In our Institution Decision, we did not find these contentions persuasive based on the initial record. Dec. 20–24. Patent Owner has not presented these or any other arguments contesting Ground 1 as to claim 1 in its Response. Resp., the evidence and, based on that analysis, we find that Petitioner has shown by a preponderance of evidence that Kelly renders obvious the subject matter recited in these claims.” slip op. at 17

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

    “and Paulsen render obvious claims 2 and 4. Pet. 36–40. Petitioner submits that to the extent Kelly’s player account is not player’s club information or information on non-cash amounts, a person having ordinary skill in the art would have been motivated to implement these features based on the teachings of Paulsen. Id. Specifically, Petitioner asserts that Paulsen teaches player tracking cards and player tracking programs including player tracking points. Id. at 38–40 (citing Ex. 1007 ¶¶ 8, 9, 49). Petitioner argues that a person having ordinary skill in the art would have been led to add these features to Kelly’s system to provide a more detailed view of tracking play, which would allow for rewarding patronage and engagement. Id. at 36–37, 39–40 (citing Ex. 1003 ¶ 264; Ex. 1007 ¶ 10). Paulsen discloses a “gaming machine bonusing method utilizing a player tracking card.” Ex. 1007, code (54). Paulsen discloses that player tracking programs and player tracking cards were used in the art to provide rewards, or “comps,” to players based on the player’s level of patronage (e.g., to the player’s playing frequency and/or total amount of game plays at a given casino). Id. ¶ 8. These rewards were intended to maintain a player’s interest in additional game play during a visit and provide loyalty incentives to players. Id. at ¶ 9.” slip op. at 29

  Patent outcomesUS 11,335,164 unpatentable
  Claim construction§ 103 obviousness
  Patents in suitUS 11,335,164
• Axon Enterprise, Inc. / Dedrone Holdings, Inc. et al. v. Airspace Defense, Inc.Some claims unpatentable
  PTAB · Oct 6, 2026 · IPR2025-00629 · APJ Scott C Moore · IPR · Final written decision

  Original claim 12 is not unpatentable; substitute claim 37 is added, while substitute claims 21–28 and 30–36 are denied as obvious.

  RulingsFinal written decision

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

    “F.3d at 1279–80, we begin our analysis with the Specification of the ’711 Patent. The Specification indicates when a UAV (such as the recited “reference aerial vehicle”) navigates autonomously, it flies without manual control, and can, for example, track and fly to a target using information captured onboard the vehicle itself. See Ex. 1001, 3:24–28 (“[I]t may not be desirable to manually control the interceptor aerial vehicle to follow the target UAV. In some embodiments, the interceptor aerial vehicle is able to autonomously track and fly to the target UAV using machine vision based on images captured by a camera of the interceptor aerial vehicle.”). The Specification also indicates that “autonomous” means more than just “automatic flight,” and clarifies that autonomous navigation occurs when a UAV that previously received a target location from an external source subsequently turns and flies itself towards the received location. See, e.g., id. at 4:15–17 (disclosing that the detected location of a target may be provided to an interceptor “to allow it to automatically and autonomously fly toward the direction of the detected location”); 15:64–16:3 (automatic and autonomous navigation occurs when an interceptor’s navigation component and/or flight controller receive the location of a target, and adjust the interceptor “to turn and fly towards the received location . . . based on the received location”); 16:49–60 (“For example, a flight direction and/or speed of an interceptor aerial vehicle are automatically and autonomously adjusted based on a location and size of the target within the captured image. . . . This allows the flight path of the interceptor aerial vehicle to be dynamically adjusted to track and follow a moving target.”).” slip op. at 11

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

    “have had reason to combine Beard and Laufer in the manner proposed by Petitioner, the combination would not satisfy the Autonomous Navigation limitation required by claim 12 because Laufer’s autopilot commands are generated by and transmitted from a remote command center (i.e., Laufer’s central controller 115). PO Resp. 15–16. In its Reply, Petitioner does not dispute that Laufer’s autopilot commands are generated by Laufer’s central controller 115, which is remote from the aircraft being controlled. See Reply 13–17. Petitioner asserts, however, that the combination still satisfies the Autonomous Navigation limitation because these autopilot commands are generated without human input. See id. Based on the complete trial record, Patent Owner’s arguments are persuasive. See PO Resp. 15–16; PO Sur-reply 42, 1–6; Ex. 2025 ¶¶ 84–87. The flight of Beard’s UAV 100 under the control of Laufer’s autopilot commands does not satisfy the Autonomous Navigation limitation of claim 12, as we have construed that limitation, because Laufer’s autopilot commands are generated at a location that is remote from UAV 100 (Laufer’s central controller 115.) See, e.g., Ex. 1010 ¶ 40 (“Central controller 115 uses autopilot command module 440 to generate autopilot aircraft commands”), ¶¶ 26, 30 (clarifying that central controller 115 and the controlled interceptor aircraft are separate devices that may communicate through a “wireless connection”), Fig. 4 (depicting “aircraft control commands 475” being generated externally from the depicted “Interceptor Aircraft”); see also Ex. 2025 ¶¶ 95–95. Petitioner never disputes that, in the proposed combination, Laufer’s central controller 115 would remain external to Beard’s UAV 100. See Reply 13–17. Instead, Petitioner relies on its proposed construction of the Autonomous Navigation limitation, which would have encompassed such an arrangement. See id. Our construction of the Autonomous Navigation limitation, which did not adopt Petitioner’s claim construction position, is dispositive of Petitioner’s argument. We thus determine that Petitioner has not shown by a preponderance of the evidence that claim 12 would have been obvious over Beard and Laufer.” slip op. at 15

  • PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend granted in partGranted in part

    “the legal requirements set forth in 35 U.S.C. § 316(d) and 37 C.F.R. § 42.121. Lectrosonics, Paper 15 at 4, 7–8. For the reasons that follow, we determine that Patent Owner has satisfied this burden. 1. Proposal of a Reasonable Number of Substitute Claims A motion to amend must “propose a reasonable number of substitute claims.” 35 U.S.C. § 316(d)(1)(B); see also 37 C.F.R. § 42.121(a)(3) (“A motion to amend may cancel a challenged claim or propose a reasonable number of substitute claims.”). “There is a rebuttable presumption that a reasonable number of substitute claims per challenged claim is one (1) substitute claim.” Lectrosonics, IPR2018-01129, Paper 15 at 4; see also 37 C.F.R. § 42.121(a)(3). Patent Owner has shown it proposes a reasonable number of substitute claims by proposing a single substitute claim for each of challenged claims 1–4, 8–11, and 13–20. MTA 1–2, Claims App. Petitioner does not argue otherwise. See generally MTA Opp. We determine that Patent Owner meets this requirement. 2. Amendments Respond to a Ground of Unpatentability “A motion to amend may be denied where … [t]he amendment does not respond to a ground of unpatentability involved in the trial.” 37 C.F.R. § 42.121(a)(2)(i). Patent Owner has responded to the grounds of unpatentability involved in this proceeding by amending the claims in response to the Petition’s asserted prior art. See MTA 2, 25, Claims App. Petitioner does not argue otherwise. See generally MTA Opp. We determine that Patent Owner meets this requirement. 3. No Enlargement of the Scope of the Claims An amendment may not seek to enlarge the scope of the claims of the patent. 35 U.S.C. § 316(d)(3); 37 C.F.R. §§ 42.121(b)(1)–(b)(2). Patent Owner asserts that the amendments in the Motion do not enlarge the scope of the claims of the patent because each proposed substitute claim “retains all of the limitations of the corresponding challenged claim, and each proposed independent substitute claim adds further limitations.” See MTA 2, Claims App. Petitioner does not argue otherwise. See generally MTA Opp. We determine that Patent Owner meets this requirement. 4. No Introduction of New Matter An amendment may not introduce new matter. 35 U.S.C. § 316(d)(3);” slip op. at 22

  • 112 supportDecided for patent owner

    “Having considered the evidence and argument cited by both parties, we determine there is sufficient written description support for the disputed portions of limitations [37.e1], [37.e3,] and [37.e4]. The ’452 application discloses selecting between groups of processing schemes (e.g., algorithms) depending on a confidence level, where the groups are, for example: high cost, high robustness algorithms; medium cost, medium robustness algorithms; and low cost, low robustness algorithms. See Ex. 2019 ¶¶ 146–147. These schemes or algorithms may be neural networks. See, e.g., id. ¶ 50 (including neural network as a type of algorithm); see also id. ¶¶ 109–110); see generally MTA Opp 1 (not disputing that schemes may be neural networks). Specifically, the ’452 application describes “algorithms that process video frames of one or more video data streams,” and “produce a prediction of objects within the video f[r]ame, as well as a confidence number that is a measure of quality for that prediction.” Id. ¶ 141. The ’452 application also discloses the concept of switching between neural networks based on confidence levels. In particular, the ’452 application discloses that a “process cycles through the processing schemes to produce a detection of an object,” for example, where “if the confidence number is higher than an activation number, an action is performed to stop or change a running group (i) and select or switch to group (ii).” Id. ¶ 146. More particularly, “a processing scheme from the group of (i) High cost (low refresh rate), high robustness algorithm[s] can select a cheaper processing scheme from the group of (ii) Medium cost, medium robustness algorithms.” Id. The ’452 application additionally discloses that schemes or algorithms (e.g., neural networks) are applied to individual video frames, and that the confidence levels that determine which neural network will be applied in the future are also derived from individual video frames. For example, as discussed above, the ’452 application describes that “[t]he processing schemes produce a prediction of objects within the video f[r]ame, as well as a confidence number that is a measure of quality for that prediction.” Ex. 2019 ¶ 141 (emphases added). The ’452 application also describes selecting and applying an individual neural network, rather than only selecting and applying a group of processing schemes. For example, as highlighted above, the ’452 application describes that “a processing scheme from the” “High” group “can select a cheaper processing scheme from the” “Medium” group. Id. ¶ 146 (emphases added). In our view, these disclosures, read together, would reasonably convey to one skilled in the art that the inventor had possession of the disputed subject matter described above. See Ariad, 598 F.3d at 1351.” slip op. at 24

  Patent outcomesUS 10,514,711 mixed
  Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · Graham · Nautilus
  Patents in suitUS 10,514,711
• Axon Enterprise, Inc. / Dedrone Holdings, Inc. v. Airspace Defense, Inc.Other
  PTAB · Oct 6, 2026 · IPR2025-00530 · APJ Scott C Moore · IPR · Final written decision

  Original claims 1–9 were canceled; the non-contingent motion to add substitute claims 10–18 was denied for lack of written-description support, and claim 18 was also indefinite.

  RulingsFinal written decision

  • 112 supportMotion to amend, deniedDenied

    “that either the ’303 application or the ’838 provisional contain adequate written description support for the disputed feature of limitation [10.d]. Though the disclosures cited by Patent Owner indicate that a secondary identifier can be used to aid in verification of a UAV, these disclosures also make clear that both first and second identifiers are transmitted by and received from the UAV. See, e.g., Ex. 2002, 4:15–17, 30:24–31:6; Ex. 2003 ¶¶ 14, 66. Patent Owner’s reliance on disclosure characterized as transmitting an identifier from a remote computing system “through the UAV” (Reply 2) is not persuasive. The cited disclosures from the ’303 application and ’838 provisional generally disclose that the identifiers transmitted by a UAV can be “generated remotely,” such as by a “remote computing system.” Ex. 2002, 14:23–15:2; Ex. 2003 ¶ 45. But Patent Owner has not identified disclosure indicating that a remote computing system may transmit an identifier to the identification receiver. In the ’303 application and ’838 provisional, only the UAV (which is part of the discrimination system, and thus not “remote”) actually transmits identifiers to the identification receiver. Patent Owner is correct in its assertion that an “aerial system identifier can be generated on-board the aerial system” or “generated remotely . . . at a remote computing system.” Mot. 7 (citing Ex. 2002, 14:23–15:2; Ex. 2003 ¶ 45). But even if a UAV’s identifier was at some time in the past generated by a remote computing system, the subsequent transmission of that identifier from the UAV to the identification receiver would not satisfy the plain language of limitation [10.d]. The claim language “receive … a second identifier from a computing system that is remote to the discrimination system” requires the receipt of a transmission of the second identifier from a remote computing system. This claim language limits the source of the received transmission (i.e., where the particular transmission is “receive[d] … from”). Thus, the relevant issue is from where was the recited second identifier received. The relevant is not where the second identifier was originally generated.” slip op. at 12

  • Disclosure Requirements (§112) › Definiteness (Nautilus)DefiniteIndefiniteMixed

    “We determine that the disputed language in limitation [10.d] is not indefinite. There is no recitation in proposed substitute claim 10 that the second identifier is transmitted solely from the identifier transmission system. Thus, the alleged irreconcilable contradiction cited by Petitioner is not recited in the claims. Petitioner’s position appears to rest on the fact that the ’303 application and ’838 provisional do not disclose receiving the second identifier from a remote computing system. See Sur-reply 6 (“To manufacture written description support, [Patent Owner] argues the claim encompasses identifiers routed ‘through the UAV.’”). Though we agree that limitation [10.d] lacks adequate written description support, this defect does not render the claim indefinite because the scope of limitation [10.d] is otherwise reasonably certain based on its plain language. See supra § III.C.4.” slip op. at 18

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportReference not prior artPriority date, deniedDecided for patent owner

    “In contrast, the ’393 provisional never discloses that the described drone defense system may use the identity of a detected drone to develop a particular countermeasure. The disclosed RTSS certainly uses identity information to determine whether a drone is a threat. And if a threat is identified, the RTSS immediately starts “a series of processes … to determine what rule of engagement will be applied on the intruding drone.” Ex. 1006 ¶ 10. The ’393 provisional discloses that the system may select a particular countermeasure based on (i) the particular zone within a protected area within which a drone is located, (ii) “the behavior of the hostile drone,” or (iii) “other instructions.” Id. ¶¶ 9, 10. But the ’393 provisional never discloses that these “other instructions” may include the identity of the drone. The system disclosed in the ’393 provisional uses the identity of a drone to determine whether to activate the countermeasure system. See id. ¶¶ 16–18. But there is no disclosure in the ’393 provisional that the countermeasure system, once activated, uses the identity of the drone to develop the particular countermeasure to be employed. See generally Ex. 1006. Thus, though the Whitmarsh reference itself contains ample written description support for limitation [19e], the earlier-filed ’393 provisional does not. On this record, and having reviewed the ’393 provisional in its entirety, we determine that the ’393 provisional does not “reasonably convey[] to those skilled in the art that the inventor had possession of” the subject matter of limitation [19e] of Whitmarsh’s claim 19 “as of the filing date” of the ’393 provisional. See Ariad, 598 F.3d at 1351.” slip op. at 27

  § 102 anticipation§ 112 disclosurecites Nautilus
  Patents in suitUS 10,249,199
• Axon Enterprise, Inc. / Dedrone Holdings, Inc. v. Airspace Defense, Inc.Other
  PTAB · Oct 6, 2026 · IPR2025-00525 · APJ Scott C Moore · IPR · Final written decision

  Original claim 21 was canceled; the Board denied substitute claim 22 for new matter and held it obvious under §103 based on six combinations.

  RulingsFinal written decision

  • 112 supportMotion to amend, deniedDenied

    “First, Patent Owner has not shown possession of the disputed feature of a “radio communication module [that] is configured to utilize a secure identifier, the secure identifier comprising a specified excitation.” In the ’406 application, the term “excitation” is used exclusively to refer to a light beam signal. See Ex. 2015, 7:8–13, 9:8–10, 23:9.2 The ’406 application discloses that an identification box on an aircraft may include both an RF module and a separate light sensor. See Ex. 2015, 7:3–11. But nowhere does the ’406 application describe receiving a light beam (e.g., an excitation) with the RF module of the identification box (as opposed to the light sensor), so as to provide support for proposed substitute claim 22’s recitation of a “radio communication module” configured to utilize “a secure identifier . . . comprising a specified excitation.” We disagree with Patent Owner that it suffices that one of ordinary skill in the art “would recognize that these disclosures are equally applicable to the RF-only embodiments” (Reply 5). “It is not sufficient for purposes of the written description requirement . . . that the disclosure, when combined with the knowledge in the art, would lead one to speculate as to modifications that the inventor might have envisioned, but failed to disclose.” Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997). On this record, and having reviewed the ’959 Patent, the ’153 provisional, and the ’406 application, we find no evidence in those documents that the named inventor was in possession of the concept of a radio communications module “configured to utilize a secure identifier” where “the secure identifier compris[es] a specified excitation.” Second, setting aside the “radio communication module” in proposed substitute claim 22, Patent Owner also has not shown that the named inventor was in possession of the feature of a “secure identifier comprising a specified excitation.” Patent Owner’s argument that the ’406 application describes a light beam directed to a particular aircraft (see Reply 4–5) is 2 The same is true of the ’153 provisional. See Ex. 2016 ¶¶ 29, 34. unavailing. The fact that the properties of a particular light beam indicate that the light beam is intended for a particular aircraft does not demonstrate that the light beam is a “secure identifier,” as we have construed that term. Patent Owner has not identified any disclosure in the ’406 application of a “secure identifier” comprising a light beam, let alone that such light beam can be utilized by a “radio communication module.” The only references to “secure” identifiers in the ’406 application describe radio frequency signals. See Ex. 2015, 2:4–6, 15:21–17:12.3 Having reviewed the ’959 Patent, the ’153 provisional, and the ’406 application, we find no evidence in those documents that the named inventor was in possession of the concept of a “secure identifier comprising a specified excitation.”” slip op. at 15

  • ScopeDecided for patent owner

    “not impermissibly broaden the scope of the claims of the ’959 Patent. As Patent Owner suggests, there were no limitations in original claim 21 on the type of radio signal the radio communication module could receive, and so it follows that proposed substitute claim 22 does not now encompass receiving a broader set of radio signals. We see no basis for Petitioner’s argument that the past tense verb “received” limited original claim 21 to “signals of a compatible ‘type’ and ‘range.’” Opp. 7. Moreover, the claim language (with the proposed deletion shown double brackets) provides that “the radio communication module is configured to receive a [[received]] radio signal.” Any radio signal that the radio communications module receives would necessarily be a “received” radio signal. Thus, deleting the redundant word “received” does not enlarge the scope of this claim limitation. We also are not persuaded by Petitioner’s suggestion that removing the term “received” broadens original claim 21 by deleting a requirement that the radio signal have already been previously received by the claimed device. See Sur-reply 9. Original claim 21 simply recited, using redundant language, that “the radio communication module is configured to receive a received radio signal.” Ex. 1001, 18:5–7. The most natural reading of this language is that the phrase “received radio signal” is just a description of a radio signal that is received by the recited radio communications module. Petitioner has cited no persuasive evidence that one of ordinary skill in the art would have counterintuitively interpreted this language to impose an additional requirement that the “received radio signal” must have been received twice—a first time by some other component of the device, and a second time by the recited radio communication module. Accordingly, we determine that the proposed amendment does not improperly broaden claim scope.” slip op. at 10

  • Disclosure Requirements (§112) › Definiteness (Nautilus)IndefiniteNot shown unpatentable

    “572 U.S. 898 (2014). See Memorandum: Approach to Indefiniteness Under 35 U.S.C. § 112 in AIA Post-Grant Proceedings (Jan. 6, 2021).4 Under Nautilus, a claim is indefinite if fails to “inform those skilled in the art about the scope of the invention with reasonable certainty.” 572 U.S. at 910. We agree with Patent Owner that neither of the identified terms are indefinite. Regarding the term “low-altitude aircraft,” we determine the Specification provides a sufficient basis for understanding the scope and meaning of this term with reasonable certainty. The U.S. Court of Appeals for Federal Circuit has explained that, when a term of degree is recited in a claim, it is necessary “to determine whether the patent’s specification provides some standard for measuring that degree.” See Seattle Box Co. v. Indus. Crating & Packing, Inc., 731 F.2d 818, 826 (Fed. Cir. 1984); see also Datamize, LLC v. Plumtree Software, Inc., 417 F.3d 1342, 1350 (Fed. Cir. 2005) (“Some objective standard must be provided in order to allow the public to determine the scope of the claimed invention.”). Here, the Specification describes the related art as including “small UASs (e.g., aircrafts up to 25 pounds flying up to 500 ft of the low altitude airspace).” Ex. 1001, 1:50–52. One of ordinary skill in the art would understand from the Specification that the cited disclosure provides an objective standard for determining the scope of a low-altitude aircraft as one that is designed to fly up to a maximum altitude of about 500 feet.” slip op. at 20

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “In our Institution Decision, we adopted Petitioner’s proposal that one of ordinary skill in the art would have had the following qualifications: [E]ither (1) a Bachelor of Science in Mechanical Engineering, Electrical Engineering, Aerospace engineering, or an equivalent field, as well as at least 2 years of academic or industry experience in the aerospace, avionics, telecommunications, or electronic device manufacturing industry, or (2) at least four years of industry experience in any of the above industries. Paper 13, 5 (citing Pet. 21). Patent Owner has not disputed this formulation; thus, we adopt it for purposes of this Decision. See Paper 13, 10–11 n. 8.” slip op. at 23

  § 103 obviousness§ 112 disclosurecites Graham · Nautilus
  Patents in suitUS 10,713,959
• 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
• 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

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.