• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  PTAB · Nov 17, 2025 · IPR2024-00648 · APJ Devon Zastrow Newman · IPR · Final written decision

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

  RulingsFinal written decision

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

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

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

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

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

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

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

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

  Patent outcomesUS 11,643,462 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,643,462
• Apple, Inc. v. Apex Beam Technologies LLCInstituted
  PTAB · Nov 14, 2025 · IPR2025-00911 · APJ Kevin W Cherry · IPR · Institution

  The Board instituted IPR of claims 1–16 on all asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.

  RulingsInstitution decision

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

    “We have authority under 35 U.S.C. § 314 to determine whether to institute an inter partes review. 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.” The Supreme Court has held that the Board, in a decision to institute under 35 U.S.C. § 314(b), may not institute review on less than all claims challenged in the petition. SAS Inst. Inc. v. Iancu, 584 U.S. 357, 363–66 (2018). Moreover, in accordance with our rules, “[w]hen 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.” 37 C.F.R. § 42.108(a) (2024); see also PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition”). Applying those standards, and upon considering the Petition, the Preliminary Response, and the evidence of record, we determine the information presented demonstrates a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of at least one of the challenged claims of the ’615 patent. Accordingly, we institute an inter partes review.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Relying on the declaration testimony of Dr. Akl, Petitioner contends that an ordinarily skilled artisan for the ’615 patent “would have had a bachelor’s degree in electrical engineering, computer engineering, computer science, or a similar field, along with two years of experience designing or developing wireless networks, including long-term evolution LTE/4G or 5G new radio (NR) cellular technology.” Pet. 3. Petitioner additionally contends that “[a]dditional years of experience could substitute for an advanced-level degree (and vice versa).” Id. Patent Owner states that “[f]or the purposes of this Preliminary Response only, Patent Owner utilizes Petitioner’s proposed level of skill in the art.” Prelim. Resp. 2. Based on this record, we adopt Petitioner’s articulation of the level of ordinary skill in the art, which is consistent with the ’615 patent and the asserted prior art, and we apply it in our obviousness evaluations below. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art, itself, can reflect appropriate level of ordinary skill in art).” slip op. at 8

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

    “Petitioner contends that “no formal construction are presently necessary for purposes of demonstrating obviousness of the Challenged Claims based on [the asserted grounds].” Pet. 9. Patent Owner does not at this time address claim construction. See generally Prelim. Resp. Having considered the record, we determine that no express claim construction is necessary for any claim terms. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (holding that only claim terms in controversy need to be construed, and only to the extent necessary to resolve the controversy (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). We note, however, there may be some claim terms below whose constructions the parties may wish to address during trial.” slip op. at 9

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

    “On the current record, we find that Petitioner has shown sufficiently that Cirik teaches the claimed “configuration parameters comprising first random access parameters, for beam failure recovery.” See Pet. 13– 17. Patent Owner argues that Petitioner fails to address this limitation, but we disagree. Prelim. Resp. 3. As we have set out above, Petitioner has provided a detailed mapping of what disclosures of Cirik (and Cirik’s provisional) on which it relies. Based on the current record, we see nothing incorrect in Petitioner identifying multiple parameters as making up the “configuration parameters comprising first random access parameters, for beam failure recovery.” As the plain language of claim 1 makes clear, there are “parameters”—plural—not just one. We also find, on the current record, that those “parameters” are not limited by the claim to only “random access parameters.” The disputed claim limitation uses the transitional phrase “comprising” in reciting the “configuration parameters comprising first random access parameters, for beam failure recovery.” As courts have explained, “[i]n the parlance of patent law, the transition ‘comprising’ creates a presumption that the recited elements are only a part of the device, that the claim does not exclude additional, unrecited elements.” Crystal Semiconductor Corp. v. TriTech Microelectronics Int’l, Inc., 246 F.3d 1336, 1348 (Fed. Cir. 2001). Claim 1 recites “configuration parameters comprising first random access parameters, for beam failure recovery.” Thus, we agree with Petitioner that the “configuration parameters comprising first random access parameters, for beam failure recovery,” can—but are not required to—include additional parameters (i.e., in addition to the recited “first random access parameters”). Here, we find that, on the current record, Petitioner has shown sufficiently Cirik’s “configuration parameters [that] may indicate the maximum number of beam of beam failure counter” are such parameters for beam failure recovery. Ex. 1005 ¶ 307; Ex. 1003 ¶ 52. As the Petition’s citations suggest, these are substantially the same as examples identified in the ’615 patent. See Pet. 15–16 (citing Ex. 1001, 63:18–23, 41:65–67; Ex. 1003 ¶ 56). Petitioner has further sufficiently shown that Cirik also discloses that as part of its beam failure recovery process, Cirik initiates certain “random access (RA) procedures.” Id. at 16 (citing Ex. 1005 ¶ 152, 161–164, Figs. 13A–C). As part of these RA procedures, we agree that Cirik discloses sending a configuration message including “one or more random access channel (RACH) parameters.” Id. (citing Ex. 1005 ¶¶ 151–154, 156, 161; Ex. 1003 ¶ 57). As Petitioner explains, “[t]he RACH parameters included in a configuration message can include indications of ‘one or more Physical RACH (PRACH) occasions available for transmission’ of a random-access preamble message and information for determining the power level of the transmission.” Id. (citing Ex. 1005 ¶¶ 153, 154). Cirik explains this “contention-free random access procedure . . . may be initiated for beam failure recovery.” Ex. 1005 ¶ 162; see also Pet. 20–23 (discussing in detail in the context of limitation [1b] the RA procedures for beam failure recovery in Cirik). We note that nothing in the claim language requires that the configuration parameters must be received in a single message. Thus, there is nothing improper about the Petitioner identifying multiple messages as including the “configuration parameters, comprising first random access parameters, for beam failure recovery” (i.e., Cirik’s configuration parameters that indicate the maximum number of beam failures and Cirik’s configuration parameters for random access processes used in connection with beam failure recovery), as Patent Owner suggests. Prelim. Resp. 4 (“But at no point does Petitioner assert that the configuration message for first random access parameters is included within the ‘one or more configuration parameters [that] indicate the maximum number of beam failures’ that it identifies for the ‘configuration parameters’ limitation.”). Accordingly, for purposes of institution, we find that Petitioner has shown sufficiently that Cirik discloses this limitation.” slip op. at 16

  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,637,615
• Apple, Inc. v. Apex Beam Technologies LLCInstituted
  PTAB · Nov 14, 2025 · IPR2025-00910 · APJ Kevin W Cherry · IPR · Institution

  Instituted IPR of claims 1–19 on all asserted grounds after finding a reasonable likelihood that Apple would prevail on at least one claim, including over Cirik alone.

  RulingsInstitution decision

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

    “Applying those standards, and upon considering the Petition, the Preliminary Response, and the evidence of record, we determine the information presented demonstrates a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of at least one of the challenged claims of the ’128 patent. Accordingly, we institute an inter partes review.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Relying on the declaration testimony of Dr. Akl, Petitioner contends that an ordinarily skilled artisan for the ’128 patent “would have had a bachelor’s degree in electrical engineering, computer engineering, computer science, or a similar field, along with two years of experience designing or developing wireless networks, including long-term evolution LTE/4G or 5G new radio (NR) cellular technology.” Pet. 4. Petitioner additionally contends that “[a]dditional years of experience could substitute for an advanced-level degree (and vice versa).” Id. Patent Owner states that “[f]or the purposes of this Preliminary Response only, Patent Owner utilizes Petitioner’s proposed level of skill in the art.” Prelim. Resp. 2. Based on this record, we adopt Petitioner’s articulation of the level of ordinary skill in the art, which is consistent with the ’128 patent and the asserted prior art, and we apply it in our obviousness evaluations below. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art, itself, can reflect appropriate level of ordinary skill in art).” slip op. at 8

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

    “Petitioner contends that “no formal construction are presently necessary for purposes of demonstrating obviousness of the Challenged Claims based on [the asserted grounds].” Pet. 9. Patent Owner does not at this time address claim construction. See generally Prelim. Resp. Having considered the record, we determine that no express claim construction is necessary for any claim terms. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (holding that only claim terms in controversy need to be construed, and only to the extent necessary to resolve the controversy (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). We note, however, there may be some claim terms below whose constructions the parties may wish to address during trial.” slip op. at 9

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

    “On the current record, we find that Petitioner has shown sufficiently that Cirik teaches the claimed “first configuration parameters for beam failure recovery, comprising first random access parameters.” See Pet. 13– 17. Patent Owner argues that Petitioner fails to address this limitation, but we disagree. Prelim. Resp. 3. As we have set out above, Petitioner has provided a detailed mapping of what disclosures of Cirik (and Cirik’s provisional) on which it relies. Based on the current record, we see nothing incorrect in Petitioner identifying multiple parameters as making up the “first configuration parameters for beam failure recovery.” As the plain language of claim 1 makes clear, there are “parameters”—plural—not just one. We also find, on the current record, that those “parameters” are not limited by the claim to only “random access parameters.” The disputed claim limitation uses the transitional phrase “comprising” in reciting the “first configuration parameters for beam failure recovery.” As courts have explained, “[i]n the parlance of patent law, the transition ‘comprising’ creates a presumption that the recited elements are only a part of the device, that the claim does not exclude additional, unrecited elements.” Crystal Semiconductor Corp. v. TriTech Microelectronics Int’l, Inc., 246 F.3d 1336, 1348 (Fed. Cir. 2001). Claim 1 recites “first configuration parameters for beam failure recovery, comprising first random access parameters.” Thus, we agree with Petitioner that the “first configuration parameters for beam failure recovery” can—but are not required to—include additional parameters (i.e., in addition to the recited “first random access parameters”). Here, we find that, on the current record, Petitioner has shown sufficiently Cirik’s “one or more configuration parameters [that] may indicate the maximum number of beam of beam failure counter” is such a parameter for beam failure recovery. Ex. 1005 ¶ 307; Ex. 1003 ¶ 52. As Petitioner correctly notes, these are substantially the same as examples of “first configuration parameters for beam failure recovery” identified in the ’128 patent. See Pet. 15 (citing Ex. 1001, 63:9–12, 41:65–67; Ex. 1003 ¶ 53). Petitioner has further sufficiently shown that Cirik also discloses that as part of its beam failure recovery process, Cirik initiates certain “random access (RA) procedures.” Id. (citing Ex. 1005 ¶ 152, 161–164, Figs. 13A– C). As part of these RA procedures, we agree that Cirik discloses sending a configuration message including “one or more random access channel (RACH) parameters.” Id. (citing Ex. 1005 ¶¶ 151–154, 156, 161; Ex. 1003 ¶¶ 54–55). As Petitioner explains, “[t]he RACH parameters included in a configuration message can include indications of ‘one or more Physical RACH (PRACH) occasions available for transmission’ of a random-access preamble message and information for determining the power level of the transmission.” Id. (citing Ex. 1005 ¶¶ 153, 154). Cirik explains this “contention-free random access procedure . . . may be initiated for beam failure recovery.” Ex. 1005 ¶ 162; see also Pet. 20–23 (discussing in detail in the context of limitation [1b] the RA procedures for beam failure recovery in Cirik). We note that nothing in the claim language requires that the first configuration parameters must be received in a single message. Indeed, the claim language explicitly permits “one or more messages.” Thus, there is nothing improper about the Petitioner identifying multiple messages as including the “first configuration parameters for beam failure recovery” (i.e., Cirik’s configuration parameters that indicate the maximum number of beam failures and Cirik’s configuration parameters for random access processes used in connection with beam failure recovery), as Patent Owner suggests. Prelim. Resp. 4 (“But at no point does Petitioner assert that the configuration message for first random access parameters is included within the ‘one or more configuration parameters [that] indicate the maximum number of beam failures’ that it identifies for the ‘first configuration parameters’ limitation.”). Accordingly, for purposes of institution, we find that Petitioner has shown sufficiently that Cirik discloses this limitation.” slip op. at 15

  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,979,128
• Apple Inc. v. Apex Beam Technologies LLCInstituted
  PTAB · Nov 14, 2025 · IPR2025-00909 · APJ Justin T Arbes · IPR · Institution

  The Board instituted IPR of claims 1–20 on all asserted grounds after finding a reasonable likelihood that claim 1 is unpatentable over Ying and Yang.

  RulingsInstitution decision

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

    “c) Conclusion Petitioner’s contentions are supported by the testimony of Dr. Akl and are persuasive based on the current record. See Pet. 7–28; Ex. 1003 ¶¶ 58–83. Petitioner has shown a reasonable likelihood of prevailing on its assertion that claim 1 is unpatentable over Ying and Yang. Accordingly, we institute review “on all of the challenged claims and on all grounds of unpatentability asserted for each claim.” See 37 C.F.R. § 42.108(a). 4. Claims 2–20 Patent Owner does not argue dependent claims 2–20 separately. Prelim. Resp. 3–5. On this record, we disagree with Patent Owner’s arguments regarding parent claim 1 and are persuaded that Petitioner has shown a reasonable likelihood of prevailing on its assertion that claim 1 is unpatentable over Ying and Yang. See supra Section II.D.3. Accordingly, we need not determine at this time whether Petitioner also has shown a reasonable likelihood of prevailing as to any of the other challenged claims. See 37 C.F.R. § 42.108(a).” slip op. at 21

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

    “C. Claim Interpretation We interpret each challenged claim using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. 282(b), including construing the claim in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent. 37 C.F.R. § 42.100(b). Petitioner argues that “no claim terms need be construed.” Pet. 6–7. Patent Owner states that “claim construction is not required to resolve any issues.” Prelim. Resp. 2. We conclude that no express interpretation of any claim term is necessary to determine whether to institute an inter partes review in this proceeding. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“Because we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy,’ we need not construe [a particular claim limitation] where the construction is not ‘material to the . . . dispute.’” (emphasis added) (citation omitted)).” slip op. at 11

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “B. Level of Ordinary Skill in the Art Petitioner argues that at the time of the ’695 patent (November 2019),4 a person of ordinary skill in the art would have had “a bachelor’s degree in electrical engineering, computer engineering, computer science, or a similar field, along with two years of experience designing or developing wireless networks, including long-term evolution LTE/4G or 5G new radio (NR) cellular technology,” where “[a]dditional years of experience could substitute for an advanced-level degree (and vice versa).” Pet. 6 (citing Ex. 1003 ¶¶ 29–32). Patent Owner “utilizes Petitioner’s proposed level of skill in the art” for its Preliminary Response. Prelim. Resp. 2. Based on the record presented, including our review of the ’695 patent and the types of problems and solutions described in the ’695 patent and cited prior art, we agree with Petitioner’s proposed definition of the level of ordinary skill in the art and apply it for purposes of this Decision.” slip op. at 10

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

    “3. Claim 1 a) Petitioner’s Contentions Petitioner argues that Ying and Yang collectively teach all of the limitations of claim 1 and a person of ordinary skill in the art would have been motivated to combine their teachings, with a reasonable expectation of success. Pet. 11–28. As to the combination of references, Petitioner asserts that a person of ordinary skill in the art “would have been motivated to include configuration parameters for both the NUL and SUL carriers, as taught in Ying, in a single DCI, as expressly depicted in Yang, to coordinate both normal uplink (NUL) and supplemental uplink (SUL) transmissions in a mobile communication environment.” Id. at 12 (citing Ex. 1003 ¶¶ 58–59). According to Petitioner, “[t]he combination involves coordinating both carriers already operating in the mobile communication environment by implementing Ying’s DCI example (e.g., in Listing 6) to provide cancellation indications for both the normal uplink (NUL) and the SUL in one DCI,” achieving the “predictable result” of “improv[ed] communication capacity, speed, flexibility, and/or efficiency.” Id. at 12–13 (quoting Ex. 1004, col. 1, ll. 31–41). Petitioner also alleges various other reasons for why a person of ordinary skill in the art would have been motivated to combine the references’ teachings in that manner, including “reduced communication overhead,” simplification of the UE’s decoder operation, and the need to choose from only two options (i.e., “using one DCI to encode both NUL and SUL carriers . . . or using two DCIs”). Id. at 13–17 (citing Ex. 1003 ¶¶ 60–64).” slip op. at 15

  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 10,986,695
• Apple Inc. v. Apex Beam Technologies LLCInstituted
  PTAB · Nov 14, 2025 · IPR2025-00907 · APJ Justin T Arbes · IPR · Institution

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

  RulingsInstitution decision

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

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

  • Skill levelSkill level petitioner adoptedDecided for petitioner

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

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

    “C. Claim Interpretation We interpret each challenged claim using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. 282(b), including construing the claim in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent. 37 C.F.R. § 42.100(b). Petitioner argues that “no claim terms need be construed.” Pet. 8. Patent Owner does not propose interpretations of any claim terms in its Preliminary Response. We conclude that no express interpretation of any claim term is necessary to determine whether to institute an inter partes review in this proceeding, but encourage the parties to address various claim interpretation issues identified below during trial. See infra Section II.D.5; Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“Because we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy,’ we need not construe [a particular claim limitation] where the construction is not ‘material to the . . . dispute.’” (emphasis added) (citation omitted)).” slip op. at 11

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

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

  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,139,944
• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  PTAB · Nov 6, 2025 · IPR2024-00623 · APJ Devon Zastrow Newman · IPR · Final written decision

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

  RulingsFinal written decision

  • Expert testimonyPetitioner expert creditedDecided for petitioner

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

  • Skill levelSkill level board ownDecided for petitioner

    “In light of the extent of the relevant field, we determine that the level of skill in the art relevant to the claims of the ’974 patent is not limited to knowledge of and experience with conducting research relating to oncology or developing and conducting clinical trials, but includes knowledge of and experience with treating cancer patients with immunotherapy compounds, identifying the conditions these patients may have, and understanding the literature regarding clinical trials for such colorectal cancers and the associated conditions and immunotherapy.” slip op. at 9

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable

  Patent outcomesUS 11,325,974 unpatentable
  § 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,325,974
• Apple Inc. v. Apex Beam Technologies LLCInstituted
  PTAB · Nov 5, 2025 · IPR2025-00895 · APJ Scott Raevsky · IPR · Institution

  The Board instituted IPR on claims 1–20 and all asserted challenges after finding a reasonable likelihood that at least one challenged claim would be unpatentable.

  RulingsInstitution decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “A person of ordinary skill in the art (POSITA) would have had at least [a bachelor’s degree in] electrical engineering, computer engineering, computer science, or a similar field, along with two years of experience designing or developing wireless networks. Additional education might substitute for some of the experience, and additional substantial experience might substitute for some of the educational background. . . . A POSITA would also have familiarity with the 3GPP LTE standards, and would have understood how to search through the available Technical Specifications for implementing RAN technologies. Pet. 21–22 (citing Ex. 1003 ¶¶ 50–53). Patent Owner uses Petitioner’s proposed level of skill in the art at this stage, with a proposed modification to insert “a bachelor’s degree in” to Petitioner’s statement. Prelim. Resp. 12–13; id. at 12, n.1. We have inserted this proposed modification in brackets in the above block quotation. We are persuaded, on the present record, that Petitioner’s proposal, as modified by Patent Owner, is consistent with the problems and solutions in the ’113 patent and prior art of record. We adopt Petitioner’s skill definition at this stage.” slip op. at 7

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

    “The parties do not propose any claim constructions. See Pet. 11–12; Prelim. Resp. 8. As no terms are in dispute, we determine that no terms require construction at this stage.” slip op. at 8

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

    “IV. CONCLUSION At this stage of the proceeding, we determine that Petitioner has demonstrated a reasonable likelihood of prevailing on its challenges as to at least one challenged claim. At this preliminary stage, we have not made a final determination as to the patentability of the challenged claims or any underlying factual and legal issues. V. ORDER It is, therefore, ORDERED that, pursuant to 35 U.S.C. § 314(a), an inter partes review of all challenged claims of the ’113 patent is instituted with respect to all challenges of unpatentability set forth in the Petition; and FURTHER ORDERED that pursuant to 35 U.S.C. § 314(c) and 37 C.F.R. § 42.4, notice is hereby given of the institution of a trial commencing on the entry date of this Decision.” slip op. at 18

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

    “measurement value, as Jover teaches.” Id. (citing Ex. 1005 ¶¶ 39–40; Ex. 1003 ¶¶ 115–30). Among other reasons, Petitioner contends that a POSITA would have been motivated to combine “to improve the accuracy and reliability of the beam failure determination.” Id. at 37 (citing Ex. 1003 ¶¶ 115–30). Petitioner further contends that a POSITA would have had a reasonable expectation of success because “it would have been straightforward for a POSITA to implement Jover’s triggering condition in Xia’s method.” Id. at 38 (citing Ex. 1003 ¶¶ 115–30). After considering Patent Owner’s arguments, which we address below, we agree with Petitioner at this stage that the combination of Xia and Jover renders obvious limitation [1e]. Patent Owner first argues that Jover “does not cure the deficiencies of Xia because Jover’s threshold condition for an increase in BER is not used for triggering a transmission of the first and second radio signal.” Prelim. Resp. 20. Just like Xia, Patent Owner contends, Jover discloses no “causality between the threshold being exceeded and transmitting the first and second radio signal.” Id. at 21. This argument does not undermine Petitioner’s showing at this stage because Petitioner relies on Xia, not Jover, for the claimed “triggering the transmission,” or “causality,” as Patent Owner calls it. See Pet. 36–38. That is, Petitioner relies on Jover for the triggering condition and on Xia for the actual triggering. See id. Patent Owner’s argument attacking the references individually is unpersuasive. See In re Merck & Co., Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986) (“Non-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of refences.”). Patent Owner next contends that one of ordinary skill in the art would not have combined Xia and Jover “since Jover is directed to the opposite objective of the ’113 Patent or Xia.” Prelim. Resp. 21. That is, Patent Owner asserts, Jover teaches away from the disclosed methods. Id. at 22. Patent Owner explains, “Jover provides no attempt to improve the beam strength, but rather ignores it through beam sweeping or nullif[ies] it, in contrast to the purpose of the ’113 Patent.” Id. at 22–23. At this stage, Patent Owner’s argument is insufficient to undermine” slip op. at 15

  Claim construction§ 103 obviousness
  Patents in suitUS 10,568,113
• 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
• Apple Inc. v. Apex Beam Technologies LLCInstituted
  PTAB · Oct 31, 2025 · IPR2025-00900 · APJ Jeffrey S Smith · IPR · Institution

  The Board instituted IPR on claims 1–20 on all asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.

  RulingsInstitution decision

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

    “Institution of an inter partes review may not be authorized by statute “unless . . . the information presented in the petition . . . and any response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon consideration of the record before us, we determine Petitioner has demonstrated a reasonable likelihood that it would prevail in establishing the unpatentability of at least one of claims 1– 20 of the ’727 patent. Accordingly, we institute the requested inter partes review.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “A person of ordinary skill in the art (“POSITA”) relating to the subject matter of the ’727 Patent as of [November 1, 2016] would have a bachelor’s degree in electrical engineering, computer engineering, computer science, or a similar field, along with two years of experience designing or developing wireless networks, including long-term evolution LTE/4G or 5G new radio (NR) cellular technology. APPLE-1003, Section V. Additional education might substitute for some of the experience, and additional substantial experience might substitute for some of the educational background. Id. Pet. 3–4. Patent Owner at this stage utilizes Petitioner’s proposed level of skill in the art. Prelim. Resp. 5. As Petitioner’s definition of a person of ordinary skill appears commensurate with the subject matter before us, we apply Petitioner’s definition for purposes of this Decision.” slip op. at 5

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

    “On this record, we agree with Petitioner. Patent Owner, in contending that Park’s hybrid CSI signal does not describe two signalings, does not address Petitioner’s mapping of the claimed “first signaling” and the claimed “second signaling.” Petitioner persuasively maps the claimed “first signaling” to Park’s hybrid CSI signal (Pet. 21), and persuasively maps the claimed “second signaling” to Park’s DCI format signal (Pet. 30). Patent Owner does not explain why Park’s DCI format signal does not describe the claimed “second signaling.” On this record, we are sufficiently persuaded by Petitioner and Dr. Akl that Park’s DCI format signal, which triggers the UE to perform aperiodic CSI reporting, describes a “second signaling . . . used to determine the Q2 antenna port(s)” as recited in limitation 1.6. See Ex. 1003 ¶¶ 137–142; Ex. 1005, 38:20–36.” slip op. at 7

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

    “include Shin’s CSI request field provides the benefit of allowing the network to directly configure the CSI report behavior of a UE, such that the base station can obtain channel state information regarding specific channels used by the UE and the base station in order to exchange data as taught by Shin. Pet. 59 (citing Ex. 1003 ¶ 71). Petitioner also contends that adding Shin’s CSI request field to the DCI format signal of Park is the combination of familiar elements according to known methods that yields a predictable result, and that the combination uses Shin’s known technique of including a CSI request field in a DCI format signal to improve Park’s DCI format signal in the same way. Id. at 58 (citing Ex. 1003 ¶ 69; KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 415–421 (2007)).” slip op. at 9

  § 102 anticipation§ 103 obviousnesscites KSR
  Patents in suitUS 11,063,727
• 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

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.