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  • PTAB · Oct 7, 2025 · IPR2025-00597 · APJ David C Mckone · IPR · Institution

    The Board instituted review of claims 1–22 on all asserted grounds after finding a reasonable likelihood that claims 1–22 would have been obvious over Beel and Dinka.

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

      “In sum, on the current record, Petitioner has shown a reasonable likelihood that claim 1 would have been obvious over Beel and Dinka. f) Claims 2–22 The parties present their arguments for independent claim 11 along with those for claim 1. Pet. 44–45; Prelim. Resp. 19, 23. Claims 2–10 and 22 depend, directly or indirectly, from claim 1. Claims 12–21 depend, directly or indirectly, from claim 11. Patent Owner does not present separate arguments for claim 11 or the dependent claims. We have analyzed Petitioner’s arguments and evidence for claims 2–22 (Pet. 36–46) and, on the current record, conclude that Petitioner has shown sufficiently that claims 2–22 would have been obvious over Beel and Dinka.” slip op. at 25

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “III. ANALYSIS A. Level of Ordinary Skill in the Art Petitioner, relying on the testimony of Dr. Almeroth and alleged admissions by Patent Owner in litigation, contends that a person of ordinary skill in the art would have had “a Master of Science (M.S.) degree in electrical engineering or computer science, and five years of work experience in a related field” and that “[a]dditional educational experience could substitute for some of the work experience.” Pet. 8 (citing Ex. 1002 ¶¶ 36–37). “Patent Owner does not dispute Petitioner’s proposed level of skill in the art at this time.” Prelim. Resp. 6. For purposes of this Decision, we adopt Petitioner’s description of the level of ordinary skill in the art, as it is consistent with the technology described in the ’346 patent and the asserted prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 7

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionNo construction neededOther

      “Patent Owner accepts the Petition’s claim construction for the purposes of” the Preliminary Response. Prelim. Resp. 5–6. In light of Patent Owner’s acceptance, and because the proposed constructions are, on this record, consistent with the evidence cited by Petitioner, we, too, accept Petitioner’s proposals for “providing simulations or translations, as required,” and “data transformations,” as recited in claim 1, for purposes of this Decision. Based on the record before us, we do not find it necessary to provide express claim constructions of any other claim terms. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (noting that “we 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)). slip op. at 8

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner

      “Patent Owner argues that Dr. Almeroth does not provide a reason why a skilled artisan would have been motivated to combine Beel and Dinka, and that, instead, he “summarily concludes that Skype’s status as ‘well-known’ somehow would have motivated the combination of Dinka with Beel.” Prelim. Resp. 16. We disagree. Dr. Almeroth testifies that Skype, as taught in Dinka, would have been an example of the type of application that would have run on Beel’s system and that applying Dinka’s teachings would have improved Beel’s similar system in the same manner as it improved Dinka’s, with predictable results. Ex. 1002 ¶¶ 117, 132. See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007) (“[W]hen a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious.” (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273, 282 (1976))). On the current record, including Dr. Almeroth’s testimony, Petitioner’s proposed reasons to combine the teachings of Beel and Dinka have rational underpinning.” slip op. at 17

    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 11,966,346
  • PTAB · Oct 1, 2025 · IPR2025-00573 · APJ Meredith C Petravick · IPR · Institution

    The Board denied institution because the Petition did not show a reasonable likelihood that claims 7 or 11 were unpatentable under the asserted obviousness grounds.

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

      “Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless the information presented in the petition “shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” After considering the Petition, the Preliminary Response, and the evidence of record, we determine the information presented fails to show a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of at least one of the challenged claims of the ’772 patent. Accordingly, we do not institute an inter partes review of claims 7 and 11 of the ’772 patent on the grounds asserted in the Petition.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner contends a person having ordinary skill in the art (“POSA”) pertaining to the ’772 patent “would have had an educational background of, engineering, computer engineering, computer science, or equivalent training, and approximately three years of experience with electronic payment systems, vending machine technologies, or distributed network systems.” Pet. 19–20; Ex. 1003 ¶¶ 20–26. “Lack of work experience can be remedied by additional education, and vice versa.” Pet. 20; Ex. 1003 ¶ 22. Patent Owner does not oppose Petitioner’s formulation of ordinary skill. See Prelim. Resp. generally. On this record, we adopt Petitioner’s assessment of the level of ordinary skill in the art as it is consistent with the ’772 patent and the asserted prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 9

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

      “In this inter partes review, we apply the same claim construction standard that would be used in a civil action under 35 U.S.C. § 282(b). 37 C.F.R. § 42.100(b). In applying this standard, we generally give claim terms their ordinary and customary meaning as would be understood by a person of ordinary skill in the art at the time of the invention and in the context of the entire patent disclosure. See id.; Phillips v. AWH Corp., 415 F.3d 1303, 1312–14 (Fed. Cir. 2005) (en banc). We do not need to construe any terms expressly to determine whether or not to institute a trial. See Realtime Data LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 10

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 11,481,772
  • PTAB · Oct 1, 2025 · IPR2024-00703 · APJ Meredith C Petravick · IPR · Final written decision

    Claims 1–58 were not shown unpatentable: the Edwards, Ingle, and Mosher combination fails to establish key limitations, and Ollivier was not shown to be a prior art printed publication.

    RulingsFinal written decision
    • Skill levelSkill level patent owner adoptedDecided for patent owner

      “We apply Patent Owner’s proposed definition, as it appears consistent with the field of the ’511 patent and the prior art and is consistent with testimony of Dr. Poulos and the cross-examination testimony of Dr. Berenholz. See Okajima v. Bourdeau, 261 F.3d 1350, 1355, (Fed. Cir. 2001) (the level of ordinary skill in the art may be reflected in the prior art itself); Ex. 2001 ¶¶ 35–39; Ex. 2005, 55:5–17, 57:17–58:19. In our view, however, Petitioner’s proposed definition is not so different that our decision would change if we were to apply Petitioner’s proposed definition.” slip op. at 9

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

      “Patent Owner’s argument are persuasive. We agree with Patent Owner that a plain reading of the wherein clause requires the treating to begin at the introitus and extend at least the first centimeter into the vagina and up to 3.5 cm in from the introitus. This construction is consistent with the ’511 patent’s Specification, which states: In typical embodiments, the length of the energy delivery element is about 1 to about 3 cm in length, in other embodiments it may be as long as about 4 cm. This is a length well adapted to treating the lower aspects of the vagina, wherein treatment by the method comprises contacting the vaginal epithelium in a region that extends from the introitus inward to a position about 3 to 4 cm inward from the introitus. In some embodiments of the invention, the method can b[e] practiced with a single row of parallel contract sites immediately inside the introitus. In other embodiments, the method may include deeper rows, or rows that overlap an initial row, while keeping the contact sites within the lower portion of the vagina. Ex. 1001, 3:28–40 (emphasis added); see also id. at 14:47–57. The ’511 patent Specification also states: “the portion of the vagina to be treated is a region between the introitus and a position located no further than about 3 to about 4 cm inward from the introitus.” Id. at 11:48–51 (emphasis added). Given the plain language of claim 1, consistent with the ’511 patent’s Specification, we construe “heating a portion of the vagina extending from the introitus inwardly to a location from 1 cm to 3.5 cm in from the introitus” to require heating a portion of the vagina beginning at the introitus and extending at least the first centimeter into the vagina and up to 3.5 cm in from the introitus.” slip op. at 12

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

      “Patent Owner’s arguments is persuasive. The cited portion of Mosher does not explicitly state the location of the treatment area. Ex. 1006 ¶ 74. In it Reply, Petitioner additionally points to paragraph 54 of Mosher, which states: “Preferably, the location of the treatment volume of endopelvic fascia will be disposed along a length of the urethra between the bladder neck and the external meatus so as to avoid injuring nerves.” Pet. Reply 14 (quoting Ex. 1006 ¶ 54). Petitioner argues that “[t]reating the vaginal wall adjacent to the mid-urethral region is within the claimed region of ‘from 1 cm to 3.5 cm in from the introitus.’” Pet. Reply 14–16. This, however, does not teach the claimed area beginning at the introitus and extending at least the first centimeter into the vagina and up to 3.5 cm in from the introitus. The Petition fails to show that either Edwards or Mosher discloses heating a portion of the vagina beginning at the introitus and extending at least the first centimeter into the vagina and up to 3.5 cm in from the introitus. In its Reply, Petitioner argues that it would have been obvious to modify Edwards to treat the area beginning at the introitus and extending at least the first centimeter into the vagina and up to 3.5 cm in from the introitus. See, e.g., Pet. Reply 2–4, 16–17 (citing Pet. 35). The Petition’s argument is unpersuasive because it is conclusory and does not adequately address Edwards’s use of a speculum. Pet. 35. The Petition includes no” slip op. at 26

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

      “In its Reply, Petitioner argues that it would have been obvious to modify Edwards to treat the area beginning at the introitus and extending at least the first centimeter into the vagina and up to 3.5 cm in from the introitus. See, e.g., Pet. Reply 2–4, 16–17 (citing Pet. 35). The Petition’s argument is unpersuasive because it is conclusory and does not adequately address Edwards’s use of a speculum. Pet. 35. The Petition includes no persuasive explanation as to why it would have been obvious to modify Edwards to use the treatment blade without the speculum. See Pet. 22–24, 35–36. We determine that Petitioner fails to meet its burden to show by a preponderance of the evidence that claim 1 is unpatentable over Edwards, Ingle, and Mosher.” slip op. at 26

    Patent outcomesUS 8,961,511 not shown unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR
    Patents in suitUS 8,961,511
  • 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
  • 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
  • PTAB · Sep 19, 2025 · IPR2024-00650 · APJ Deborah Katz · IPR · Final written decision

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

    RulingsFinal written decision
    • Skill levelSkill level board ownDecided for petitioner

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

    • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

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

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

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

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

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

    Patent outcomesUS 11,634,491 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,634,491
  • PTAB · Aug 26, 2025 · IPR2022-01531 · APJ Devon Zastrow Newman · IPR · Final written decision

    Claims 1–17, 20, 21, 24, 26, and 29–31 are unpatentable; claims 25 and 32–34 were not shown unpatentable, and the motion to exclude was dismissed as moot.

    RulingsFinal written decision
    • RemandOther

      “review of claims 1–17, 20, 21, 24–26, and 29–34 of the ’682 patent. Paper 2 (“Pet.”), 1, 3. Patent Owner, Hangzhou DAC Biotech Co., Ltd., filed a Preliminary Response (Paper 9, “Prelim. Resp.”). We initially determined that the information presented in the Petition did not establish a reasonable likelihood that Petitioner would prevail with respect to at least one of the challenged claims, and did not institute inter partes review. Paper 17. Petitioner requested Director review of our decision denying institution (Paper 18 (“Request”)). The Director delegated review of the decision to a Delegated Rehearing Panel (“DRP”). Paper 19. Patent Owner was granted the option to file a response to Petitioner’s Request (Paper 22 (“Request Resp.”)). The Delegated Review Panel vacated our decision and remanded the case to this panel with a revised claim construction for claim 1. Paper 23 (“DRP Dec.”). On August 30, 2024, we instituted an inter partes review after remand from the Director. Paper 25 (“Inst. Dec.”). Patent Owner subsequently filed a Patent Owner Response (Paper 31, “Resp.”), Petitioner filed a Reply (Paper 36, “Reply”), Patent Owner filed a Sur-reply (Paper 44, “Sur-reply”), and Petitioner filed a Sur-sur-reply (Paper 48, “Sur-sur-reply”).” slip op. at 2

    • PTAB / AIA Trials › Motions to amend / substitute claimsOther

      “I. Patent Owner’s Motion to Exclude Evidence Patent Owner moves to exclude Exhibits 1089 and 1090. Paper 50. As we did not rely on either of Exhibits 1089 or 1090 in deciding this matter, Patent Owner’s motion is dismissed as moot.” slip op. at 96

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

      “For these reasons, Patent Owner’s arguments and cited evidence also” slip op. at 31

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableNot shown unpatentableMixed

      “function as R2, and the ethyl group may function as R4, which can be a linear alkyl having 1–6 carbon atoms. We note that claim 3 permits R5 and R6 to be absent. For these reasons, the arguments presented in the Petition demonstrate that claim 3 would have been obvious over Singh’s Compound 3 when modified in view of Harris.” slip op. at 73

    Patent outcomesUS 10,131,682 mixed
    § 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 10,131,682
  • PTAB · Aug 25, 2025 · PGR2025-00028 · APJ George R Hoskins · PGR · Institution

    The Board instituted PGR on claims 1–20 and all asserted grounds after finding claim 1 more likely than not unpatentable under § 101.

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

      “Pursuant to 35 U.S.C. § 324(a), the Director may not authorize a post-grant review unless the information in the petition, if unrebutted, “would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” See 37 C.F.R. § 42.4(a) (“The Board institutes the trial on behalf of the Director.”). For the reasons that follow, we institute a post-grant review as to claims 1–20 of the ’423 patent on all grounds of unpatentability asserted in the Petition.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “ordinary skill in the art would have had “an educational background of, or practical experience equivalent to, a bachelor’s degree in electrical engineering, computer engineering, computer science, or equivalent training, and approximately three years of experience with electronic payment systems, vending machine technologies, or distributed network systems,” where “[l]ack of work experience can be remedied by additional education, and vice versa.” Pet. 20 (citing Ex. 1003 ¶¶ 20–26). Patent Owner does not address the level of ordinary skill in the art in its Preliminary Response. Based on the record presented, including our review of the ’423 patent and the types of problems and solutions described in the ’423 patent and cited 2 Petitioner states that it “takes no position on the proper priority date for the [c]hallenged [c]laims” and “uses the earliest possible priority date claimed, December 18, 2013,” for purposes of its asserted grounds. Pet. 14. prior art, we agree with Petitioner’s definition and apply it for purposes of this Decision. See, e.g., Ex. 1001, 1:42–2:21 (stating that “[t]he present application relates to the field of payment processing systems” and describing the functionality of payment accepting units in the “Background” section).” slip op. at 7

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

      “B. 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. § 42.200(b). Petitioner states that, “for purposes of [its] Petition, the Board need not construe any claim terms to resolve the parties’ disputes, and the claims should be given their ordinary and customary meaning.” Pet. 20. Patent Owner agrees that “[n]o constructions are necessary” to decide the issues disputed by the parties. Prelim. Resp. 2–3. We conclude that no express interpretation of any claim term is necessary to determine whether to institute a post-grant 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.’” (citation omitted) (emphasis added)).” slip op. at 8

    • PTAB / AIA Trials › §315(e) estoppelNot reached

      “For the reasons explained below, we conclude, on the merits and based on the current record, that Petitioner has shown that it is more likely than not that claim 1 is unpatentable as claiming patent-ineligible subject matter under 35 U.S.C. § 101. See Pet. 77–84. Accordingly, we need not determine at this time whether collateral estoppel applies based on the Board’s decision in PGR2021-00093. The parties, however, should address the issue in their papers during trial, with citations to relevant authority. In particular, the parties are encouraged to address (1) how the collateral estoppel requirement that the issue be “identical to one decided in the first action” applies in the context of an asserted ground under 35 U.S.C. § 101, and (2) the parties’ apparent disagreement as to whether collateral estoppel may be applied in such circumstances on a “limitation-by-limitation basis.” See Pet. 72, 75 (quoting Google LLC v. Hammond Dev. Int’l, Inc., 54 F.4th 1377, 1381 (Fed. Cir. 2022)); Prelim. Resp. 20–21; see also Kroy IP Holdings, LLC v. Groupon, Inc., – F.4th –, No. 2023-1359, 2025 WL 2178321, at *4 (Fed. Cir. Aug. 1, 2025) (Dyk, J., dissenting) (“In subsequent Board proceedings, it is well established that collateral estoppel applies to claims adjudicated by the Board to be unpatentable and also to ‘related claims that present identical issues of patentability,’ i.e., patentably indistinct claims. . . . ‘It is well established that patent claims need not be identical for collateral estoppel to apply.’” (citing MaxLinear, Inc. v. CF CRESPE LLC, 880 F.3d 1373, 1377 (Fed. Cir. 2018); Google, 54 F.4th at 1381)).” slip op. at 12

    Claim construction§ 101 eligibility§ 102 anticipation§ 103 obviousnesscites Mayo · Bilski · Berkheimer · Enfish · Electric Power
    Patents in suitUS 11,972,423
  • PTAB · Aug 25, 2025 · PGR2025-00027 · APJ George R Hoskins · PGR · Institution

    The Board instituted PGR of claims 1–20 on all petitioned grounds, finding claim 1 more likely than not ineligible under § 101.

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

      “A. Legal Standards — Petitioner’s Burden In a post-grant review, “the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (discussing 35 U.S.C. § 312(a)(3), which is identical to 35 U.S.C. § 322(a)(3) in requiring petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”). This 2 Pub. L. No. 112-29, 125 Stat. 284 (2011). burden of persuasion never shifts to the patent owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015).” slip op. at 10

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “B. Level of Ordinary Skill in the Art Petitioner contends a person having ordinary skill in the art pertaining to the ’920 patent “would have had an educational background of, or practical experience equivalent to, a bachelor’s degree in electrical engineering, computer engineering, computer science, or equivalent training, and approximately three years of experience with electronic payment systems, vending machine technologies, or distributed network systems.” Pet. 20; Ex. 1003 ¶¶ 20–26. Further: “Lack of work experience can be remedied by additional education, and vice versa.” Pet. 20; Ex. 1003 ¶ 22. Patent Owner does not oppose Petitioner’s formulation of ordinary skill. See Prelim. Resp. generally. Based on the record presented, including our review of the ’920 patent and the types of problems and solutions described in the ’920 patent and cited prior art, we agree with Petitioner’s definition and apply it for purposes of this Decision. See, e.g., Ex. 1001, 1:42–2:21 (stating “[t]he present application relates to the field of payment processing systems” and describing the functionality of payment accepting units in the “BACKGROUND” section).” slip op. at 11

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

      “Petitioner argues “the Board need not construe any claim terms to resolve the parties’ disputes.” Pet. 20. Patent Owner argues: “No constructions are necessary to deny institution because denial is warranted for numerous reasons that do not depend on claim construction.” Prelim. Resp. 3. However, as discussed below, several of Patent Owner’s arguments seeking to distinguish claim 1 from Low rely on underlying claim construction positions. Except as discussed below in connection with those arguments, we determine no explicit construction is needed to resolve the parties’ controversy as to whether institution should be granted here. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 12

    • Patent Eligibility (§101) › Alice/Mayo step one — 'directed to'Step1 directed to exceptionInstituted

      “We determine Petitioner has made a sufficient showing for Step 2A, Prong 1 based on the current record. Petitioner addresses each of limitations [1.2]–[1.14] and explains how they support Petitioner’s contention that the claim, as a whole, is directed to the alleged abstract idea. See Pet. 80–84. For example, Petitioner notes specifically how limitation [1.2], reciting “identifying one or more payment accepting units,” pertains to identifying a merchant, and how limitations [1.6], [1.7], and [1.9] recite user interaction using the mobile device that enables the completion of a purchase. See id. Petitioner thus shows sufficiently how claim 1, by virtue of the limitations reproduced above,5 recites the concept of “identifying a merchant and enabling completion of a purchase from the merchant.” Id. at 80.” slip op. at 21

    Claim construction§ 101 eligibility§ 103 obviousnesscites Alice · Mayo · Bilski · Berkheimer · Enfish · Electric Power
    Patents in suitUS 11,966,920
  • PTAB · Aug 11, 2025 · IPR2025-00560 · APJ Barry L Grossman · IPR · Institution

    The Board instituted IPR on claims 1–29 and every asserted ground, finding a reasonable likelihood that claim 1 is unpatentable over Chang and Fang.

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

      “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.” 35 U.S.C. § 314(a). The Board determines whether to institute a trial on behalf of the Director. 37 C.F.R. § 42.4(a).” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner asserts that a person of ordinary skill in the art would have had “bachelor’s degree in mechanical engineering or a similar field and at least two years of experience designing human breast pump equipment. More education could substitute for experience and vice versa.” Pet. 8 (citing Ex. 1003 ¶¶ 15–18). Mr. Bauer’s Declaration testimony states he considered some of the factors listed above. Ex. 1003 ¶ 17. Mr. Bauer testifies that based on his background and experience, in his opinion, the level of ordinary skill is as stated by Petitioner. Id. at 18. For purposes of this Decision, based on the prior art, the sophistication of the disclosed technology in the ’381 patent, and Mr. Bauer’s undisputed testimony, we adopt Petitioner’s definition of the level of ordinary skill.13” slip op. at 12

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

      “We do not perceive the need to construe any claim limitation. Claims must be construed “only to the extent necessary to resolve the controversy.” AstraZeneca AB v. Mylan Pharms. Inc., 19 F.4th 1325, 1345 (Fed. Cir. 2021) (quoting Vivid Techs., Inc. v. American Science & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“Because binding. We wish to have the record developed before rendering any binding determination, finding, or conclusion. 14 The citation to Ex. 1005, 2290 appears to be an error. We do not find the cited claim construction at this location. we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy,’ we need not construe the claim preambles here where the construction is not ‘material to the [obviousness] dispute.’” (citations omitted)).” slip op. at 13

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

      “Petitioner also asserts that “[m]ultiple reasons would have prompted a POSITA to implement a diaphragm pump in Chang’s breast pump device in accordance with Fang’s suggestions.” Id. at 21–24. Based on the record before us, we agree that Fang discloses a diaphragm, as recited in clause 1[a][1]. We also agree, based on the record before us, that a person of ordinary skill would have had multiple reasons to use Fang’s diaphragm pump in Chang’s device with a reasonable expectation of success.” slip op. at 21

    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 11,813,381

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.