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  • PTAB · Feb 17, 2026 · IPR2024-01230 · APJ Andreas Baltatzis · IPR · Final written decision

    Claims 1–5 are unpatentable; substitute claims 6 and 7 are unpatentable, and the Revised Motion to Amend is denied.

    RulingsFinal written decision
    • Skill levelSkill level board ownDecided for petitioner

      “our Institution Decision comports with the qualifications a person would have needed to understand and implement the teachings of the ’336 patent and the prior art of record. Inst. Dec. 15. Accordingly, we adopt the level of skill discussed in our Institution Decision. C.” slip op. at 11

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

      “Pharms. Inc. v. Amino Chemicals Ltd., 715 F.3d 1363, 1374 (Fed. Cir. 2013)). Accordingly, Patent Owner applies a different definition of “side,” in claim 1’s recitation of “an illumination area on at least two sides of the fan at top of the body,” to that definition used to understand “side[s] of the body,” discussed above. Specifically, Patent Owner argues that Petitioner’s dictionary definition of “side,” including “an area next to something” applies to “an illumination area on at least two sides of the fan at the top of the body.” See id. at 8–9.” slip op. at 17

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

      “Hasegawa, and Huang teaches or suggests the limitations of claim 3, and that one skilled in the art would have been motivated to combine those teachings with a reasonable expectation of success. See Ex. 1004 ¶¶ 136– 140; Ex. 1008, 8:4–15, 3:20–29. Accordingly, we determine that claim 3 would have been obvious over Lai and Huang, or Lai, Hasegawa, and Huang. F.” slip op. at 50

    • 112 supportMotion to amend, deniedDenied

      “c) Conclusion We conclude that Patent Owner's Revised Motion to Amend adds new” slip op. at 90

    Patent outcomesUS 10,690,336 unpatentable
    Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
    Patents in suitUS 10,690,336
  • PTAB · Jan 16, 2026 · IPR2024-01067 · APJ Andreas Baltatzis · IPR · Final written decision

    Claims 5–7, 9, and 10 are unpatentable: claims 5 and 6 are anticipated by Harvey and Riskey, claim 7 is obvious over Harvey and Rettedal, and claims 9 and 10 are obvious over Harvey and …

    RulingsFinal written decision
    • BurdenNot shown unpatentable

      “Considering the entire record, we determine that Petitioner “did not make out its obviousness case in its petition” and its arguments on reply “effectively abandoned its petition in favor of a new argument.” Wasica at 1286. To the extent Petitioner asserts the claims would have been obvious over Harvey and Riskey in the Petition, it does so using a merely conclusory statement that “[t]o the extent Patent Owner alleges that either Harvey or Riskey fails to teach any claim element, that element is provided by the other reference.” See Pet. 42; Wasica at 1286. And, as discussed in our Institution Decision, the Petition at a minimum does not explain what reference is the primary versus second reference, and what elements should be combined to reach the claimed invention. See Sisvel, 82 F.4th at 1364. reference to be modified with Riskey’s bolus and data compression. See Pet. Reply 15–17. Rather than explaining how its original petition was correct, Petitioner’s subsequent arguments amount to an entirely new theory of prima facie obviousness absent from the Petition. See Wasica, 853 F.3d at 1286; see also Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369 (Fed. Cir. 2016) (“the expedited nature of IPRs bring with it an obligation for petitioners to make their case in their petition to institute”). We decline to engage in this new argument. Accordingly, we determine that Petitioner has not met is burden to show that claims 5 and 6 would have been obvious over Harvey and Riskey. G. Asserted Obviousness of Claim 7 over Harvey and Rettedal” slip op. at 54

    • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

      “Riskey discloses “said sensor signal varies based on a corresponding change in one or more physiological parameters of said ruminant animal” (limitation 5[B]). We find Riskey’s description of temperature sensors to be persuasive evidence on this issue. Riskey discloses sensors for measuring changing animal characteristics, e.g., temperature, over time. Ex. 1005 ¶¶ 35, 44; see also id. ¶¶ 75, 76 (detecting temperature changes). We further credit Dr. Young’s testimony that one skilled in the art would understand that generated sensor signals, e.g., temperature, would change over time, whereby the sensor signal varies based on any corresponding change in the ruminant physiological parameter that the signal represents. Ex. 1002 ¶¶ 84, 85; see Cont’l Can Co. USA v. Monsanto Co., 948 F.2d 1264, 1269 (Fed. Cir. 1991) (“This modest flexibility in the rule that ‘anticipation’ requires that every element of the claims appear in a single reference accommodates the reference; that is, where technological facts are known to those in the field of the invention.”). We consider Dr. Kan’s testimony that Riskey is silent as to details about the sensor signal, but are not persuaded because the testimony appears to contradict Riskey’s disclosure of a bolus including sensors for monitoring changes in animal characteristics, generating animal characteristic messages, i.e., signals, and wirelessly transmitting data corresponding to the monitored characteristics. See Ex. 2006 ¶¶ 170–174; Ex. 1005 ¶¶ 25, 63, 67, 68, 75–78, 101. Given Riskey’s express description of monitoring animal characteristics over time, we agree with Petitioner’s argument that Riskey discloses that said sensor signal varies based on changes to the animal’s physiological parameters.” slip op. at 16

    • Skill levelSkill level board ownOther

      “Petitioner asserts that a person of ordinary skill in the art (“POSA”) as of the claimed priority date would have “had at least a bachelor’s degree in electrical engineering or a related or equivalent field, and three or more years of experience researching, developing, designing and/or evaluating sensor systems for humans or other animals.” Pet. 5 (citing Ex. 1002 ¶ 35) (emphasis added). Patent Owner does not contest Petitioner’s characterization of the level of skill in the art. See PO Resp. 12 (citing Ex. 2006 ¶¶ 19–20). On the entire record, we determine this level of skill, with the exception of the open-ended phrases “at least” and “or more,” which we remove from Petitioner’s proposal, comports with the qualifications a person 5 In the present record, neither party presents arguments or evidence relating to secondary considerations.” slip op. at 10

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

      “We construe claim terms according to the standard set forth in Phillips v. AWH Corp., 415 F.3d 1303, 1312–17 (Fed. Cir. 2005) (en banc), i.e., as construed in a civil action under 35 U.S.C. § 282(b). See 37 C.F.R. § 42.100(b). Under Phillips, claim terms are afforded “their ordinary and customary meaning.” Id. at 1312. “[T]he ordinary and customary meaning of a claim term is the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention.” Id. at 1313. “Importantly, the person of ordinary skill in the art is deemed to read the claim term not only in the context of the particular claim in which the disputed term appears, but in the context of the entire patent, including the specification.” Id. Neither party expressly seeks a specific claim construction or definition for any claim term. See Pet. 10; PO Resp. 12. To the extent Patent Owner seeks to interpret claim 7 in view of the Specification, we address that argument in our discussion of claim 7, below. See infra, § III.G.3. For purposes of this Decision, we determine that no claim terms require express construction. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”)). D. Asserted Anticipation of Claims 5 and 6 by Riskey” slip op. at 11

    Patent outcomesUS 10,231,644 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 10,231,644
  • PTAB · Dec 17, 2025 · IPR2024-01214 · APJ Sean P O’Hanlon · IPR · Final written decision

    Claims 2, 3, 6, 9, 12–14, 18, and 20 were not shown unpatentable; the motion to amend was granted for substitute claims 23, 26, 27, 29, 30, 32, 33, 37–40, and 42, and denied for …

    RulingsFinal written decision
    • Skill levelSkill level board ownOther

      “The level of ordinary skill in the art is “a prism or lens” through which we view the prior art and the claimed invention. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). The person of ordinary skill in the art is a hypothetical person presumed to have known the relevant art at the time of the invention. In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995). In determining the level of ordinary skill in the art, we may consider certain factors, including: “(1) the educational level of the inventor; (2) type of problems encountered in the art; (3) prior art solutions to those problems; (4) rapidity with which innovations are made; (5) sophistication of the technology; and (6) educational level of active workers in the field.” Best Med. Int’l, Inc. v. Elekta Inc., 46 F.4th 1346, 1353 (Fed. Cir. 2022) (quoting Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007)). “The patent’s purpose can also be informative.” Id.” slip op. at 9

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

      “The ’750 patent states that “the fluid pathway can be a radially serpentine fluid pathway which causes the fluids received in the off axis chamber to flow back and forth around a radius of the off axis chamber,” also using “radially serpentine fluid pathway” to refer to this rotation around the chamber radius “while also traversing a length of the off axis chamber.” Ex. 1001, 4:34–41 (emphasis added). This is the only description of “radially” serpentine flow in the ’750 patent. Notably, the ’750 patent does not use “radially” or “serpentine” to describe a fluid pathway “which causes the fluids to spiral around the central chamber within the off axis chamber along a length of the off axis chamber,” instead referring to such a fluid pathway as a “helical fluid pathway.” Id. at 4:41–44. See CAE Screenplates, Inc. v. Heinrich Fiedler GmbH & Co. KG, 224 F.3d 1308, 1317 (Fed. Cir. 2000) (“In the absence of any evidence to the contrary, we must presume that the use of . . . different terms in the claims connotes different meanings.”); Bd. of Regents of the Univ. of Tex. Sys. v. BENQ Am. Corp., 533 F.3d 1362, 1371 (Fed. Cir. 2008) (“Different claim terms are presumed to have different meanings.”). Inst. Dec. 11–12. We explained that the flow path depicted above, which is equivalent to that of Figure 14 of the ’750 patent, “flows circumferentially about the central chamber.” Id. at 14. We maintain this interpretation. Stated differently, the depicted flow is around a longitudinal axis of the chamber. See MTA PG 6 (describing the flow path depicted above as “a back and forth flow path around a longitudinal axis of the off axis chamber; that is, a circumferentially serpentine pathway”); see also Ex. 2003 ¶ 40 (Dr. Neitzel describing the flow path depicted above as “a back and forth flow path around a longitudinal axis of the off axis chamber”). The flow is not around a radius of the chamber, which Patent Owner recognizes is required for a flow path to be radially serpentine. See PO Resp. 10 (“Patent Owner agrees with the Board’s conclusion in the [Institution Decision] that ‘radially serpentine’ as recited in the claims of the ’750 patent means a back and forth flow around a radius of the off axis chamber.” (citation modified)); PO Sur-reply 2 (agreeing that “radially serpentine” requires “a back and forth flow around a radius of the off axis chamber”).” slip op. at 14

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

      “We agree with Patent Owner that neither Petitioner nor its witness, Mr. Nixon, has explained adequately how Thurler’s disclosure of its tube e being perforated for two thirds of its length “contemplates other lengths of perforations.” See Pet. 48; Ex. 1013 ¶ 212. Such conclusory assertions fail to apprise us of why an ordinarily skilled artisan would have been motivated to modify Thurler’s device in contradiction to Thurler’s explicit disclosure. We are also not persuaded by Petitioner’s proffered reasoning for modifying Thurler’s device. First, the modification is not a matter of design choice because the perforations allow the gases generated by firing the projectile to pass into the space between tubes e and g where they partially expand. See Ex. 1015, 1:84–91. Thus, modifying the number of perforations necessarily affects the flow of gases through the device. Next, neither Petitioner nor Mr. Nixon explains adequately how reducing the amount of perforation in tube e results in an increased fluid length. See Pet. 49; Ex. 1013 ¶ 213. Rather, although less fluid may enter into tube e with Petitioner’s modification, it appears that that fluid would travel the same distance along tubes e and h as in Thurler’s unmodified device. Finally, neither Petitioner nor Mr. Nixon explains adequately how limiting the amount of gases generated by firing the projectile from entering the expansion zones of tubes g and h provides any benefit. To the contrary, limiting the amount of gases in the manner suggested by Petitioner would reduce the suppression of such gases, resulting in a less effective device. Moreover, Thurler discloses that “there is still a space of a few millimeters between [tubes] e and g which is necessary” to prevent the application of “pressure on the projectile causing the same to deviate.” Ex. 1015, 1:106–2:3. Thus, Petitioner’s modification would not result in the passage of gases occurring only at the first three of Thurler’s tubular sleeves as asserted by Petitioner. Additionally, in the Institution Decision, we explained that Petitioner did not provide adequate reasoning to support the proposed modification of Thurler’s device regarding parent claim 1 to have concentric tubes around the central tube e. See Inst. Dec. 29–31. This shortcoming, which we maintain, carries through to dependent claim 6. Accordingly, for the foregoing reasons, Petitioner has not shown, by a” slip op. at 26

    • ScopeMotion to amend granted in partGranted in part

      “We agree with Petitioner that the amendment is broadening. Petitioner’s witness testified that he “wouldn’t call a BB gun a high energy device or a high energy weapon.” Paper 33, 18:4–6. Thus, per Petitioner’s witness, use of a BB gun would not be covered by claim 22, no matter what is discharged from the BB gun. However, if high energy material is discharged from that same BB gun, that use would be covered by proposed substitute claim 43 (assuming the other claim recitations were met). See id. at 21:10–12 (Dr. Neitzel agreeing that “if something produces a high energy material, it automatically is a high energy weapon”). Thus, by deleting “high energy device” and replacing that language with “weapon,” proposed substitute claim 43 impermissibly broadens the scope of claim 22. See Sisvel Int'l S.A. v. Sierra Wireless, Inc., 81 F.4th 1231, 1241 (Fed. Cir. 2023) (“But if a substitute claim ‘is broader in any respect it is considered to be broader than the original claim even though it may be narrower in other respects.’” (citation modified) (quoting Hockerson-Halberstadt, Inc. v. Converse Inc., 183 F.3d 1369, 1374 (Fed. Cir. 1999))); see also Lectrosonics, Paper 15 at 6 (“A patent owner may not seek to broaden a challenged claim in any respect that enlarges the scope of the claims of the patent . . . . Likewise, a proposed substitute claim may not remove a feature of the claim in a manner that broadens the scope of the claims of the challenged patent.”).” slip op. at 45

    Patent outcomesUS 8,286,750 not shown unpatentable
    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 8,286,750
  • PTAB · Dec 9, 2025 · IPR2024-00896 · APJ Andreas Baltatzis · IPR · Final written decision

    Claims 25–28 are unpatentable as obvious over the asserted Li-based combinations; claim 29 was not shown unpatentable over Li, Siam, and Tiirola.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “relevant to the challenged claims, as of the earliest claimed priority date, “would have had a bachelor’s degree in electrical engineering, computer science, computer engineering, or a related field, and two-to-three years of experience in the research, design, development, or testing of wireless data communication systems at the physical and media access control (MAC) layer.” Pet. 8 (citing Ex. 1002 ¶¶ 30–34). Patent Owner does not oppose Petitioner’s definition of a person of ordinary skill in the art. See PO Resp.; see also Ex. 2022 ¶ 22 (adopting “Petitioners’ and Dr. Valenti’s proposed definition of a person of ordinary skill in the art.”) On the complete record, we determine Petitioner’s proposed level of skill comports with the qualifications a person would have needed to understand and implement the teachings of the ’120 patent and the prior art of record. C. Claim Construction” slip op. at 10

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

      “court in the parallel litigation issued a final claim construction. Pet. Reply 2; PO Sur-Reply 3–5. The district court construed “idle power consumption” as “a power consumed by the mobile station when the mobile station is powered on and waiting to send.” Ex. 1050, 12. The parties propose that we construe the claims to match the district court’s final construction. See Pet. Reply 2; PO Sur-Reply 3; Tr. 26. We agree and adopt the district court’s final claim construction of “idle power consumption” as “a power consumed by the mobile station when the mobile station is powered on and waiting to send,” for the reasons set forth below.” slip op. at 11

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

      “2. Additional Claim Terms For purposes of institution, we determine that no other claim terms require express construction. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”)). D. Asserted Obviousness of Claims 25, 27, and 28 over Li and Siam” slip op. at 15

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

      “On the full record, we find that a preponderance of the evidence supports Petitioner’s argument that one skilled in the art would have been motivated to combine Li and Siam to reduce total power consumption including idle power consumption (Li) and circuit power consumption (Siam). Both Li and Siam describe a need for reducing energy consumption in wireless devices. See Ex. 1005 ¶ 18; Ex. 1006, 875–76. Both references further describe switching from MIMO mode to another operating mode to reduce power consumption and optimize battery life. See Ex. 1005 ¶ 19; Ex. 1006, 875 (“[W]e dynamically adjust the ‘transmission mode’ . . . so as to minimize the total energy consumption.”). In sum, the references teach the same technique, i.e., mode switching, to achieve the same goal, i.e., reducing energy consumption, in similar devices, i.e., wireless devices. See KSR, 550 U.S. at 417 (“[I]f a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would unless its actual application is beyond his or her skill.”). Accordingly, we are persuaded by Petitioner’s argument and evidence that one skilled in the art would have combined the Li and Siam with a reasonable expectation of success in doing so. See Ex. 1002 ¶¶ 91, 92.” slip op. at 20

    Patent outcomesUS 8,798,120 mixed
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 8,798,120
  • PTAB · Nov 20, 2025 · IPR2024-00875 · APJ Andreas Baltatzis · IPR · Final written decision

    Claims 1–4, 6, and 17–20 are unpatentable under the Trevarthen and Laitinen-based obviousness grounds; claim 6 was not shown unpatentable over Trevarthen alone.

    RulingsFinal written decision
    • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

      “statistics in the absence of evidence of unique downloads or individuals. Even if the download numbers do not exactly represent unique downloads by unique individuals, the evidence shows that Trevarthen was downloaded to some extent, and therefore distributed, prior to the filing date of the ’206 patent. Accordingly, we find this evidence weighs in favor of Trevarthen’s public accessibility.” slip op. at 20

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionDecided for patent owner

      “construction issues: (1) the interpretation of limitations 1[E] and 17[F] relating to entering sensed and stored information into “at least one logical expression,” and (2) “implanted in an animal.” Inst. Dec. 19. We are persuaded by Petitioner’s argument that it would have been obvious to combine sensed and stored information into the same “at least one logical expression,” for the reasons set forth below. Accordingly, we need not construe limitations 1[E] and 17[F], relating to “at least one logical expression.”4 We discuss our construction of “implanted in an animal” below.” slip op. at 12

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

      “would have viewed Trevarthen as a cohesive disclosure of specific improvements to existing dairy farms, as opposed to disparate teachings of unrelated systems. Trevarthen itself proposes “a framework for the use of RFID on dairy farms” including “enhancements and ideas which could be considered as future additions to further add value” for utilizing RFIDs in farm management beyond the Cochrane farm ear-tag RFIDs. Ex. 1005, 99. The enhancements include RFID boluses (id.), milk meters to detect illness (id. at 115), and temperature monitoring by RFID (id. at 121–122). Considering the entire record, Trevarthen itself describes improvements that apply “the predictable use of prior art elements according to their established functions.” See KSR, 550 U.S. at 417. Accordingly, we find that Petitioner has shown a that one skilled in the art would have been motivated to” slip op. at 33

    • ExcludeNot reached

      “IV. EVIDENTIARY ISSUES Patent Owner moves to exclude Exhibits 1040, 1041, and 1044.” slip op. at 81

    Patent outcomesUS 9,844,206 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 9,844,206
  • PTAB · Nov 20, 2025 · IPR2024-00885 · APJ Jamie T Wisz · IPR · Final written decision

    Claims 1–4 and 15–25 are unpatentable: claims 1–2 are anticipated by Trevarthen, and the challenged claims are also obvious over the listed combinations.

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

      “Petitioner”) filed a Petition requesting an inter partes review of claims 1–4 and 15–25 (the “challenged claims”) of U.S. Patent No. 8,823,515 B2 (Ex. 1001, “the ’515 patent”). Paper 1 (“Pet.”). ST Reproductive Technologies, LLC (“Patent Owner”) filed a Preliminary Response. Paper 6 (“Prelim. Resp.”). With our authorization, Petitioner filed a Preliminary Reply (Paper 10, “Prelim. Reply”) and Patent Owner filed a Preliminary Sur-Reply (Paper 13, “Prelim. Sur-Reply”). Upon consideration of these filings and the preliminary evidence of record, we determined that Petitioner had demonstrated a reasonable likelihood that it would prevail with respect to at least one of the challenged claims of the ’515 patent (Paper 16, “Institution Decision” or “Inst. Dec.”). Thus, we instituted review with respect to all of the challenged claims. slip op. at 2

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

      “statistics in the absence of evidence of unique downloads or individuals. Even if the download numbers do not exactly represent unique downloads by unique individuals, the evidence shows that Trevarthen was downloaded, and therefore distributed, prior to the filing date of the ’515 patent. Accordingly, we find this evidence weighs in favor of Trevarthen’s public accessibility.” slip op. at 20

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

      “retrieves sensed animal temperature information from the RFID device” and “further teaches that these temperature measurements are analyzed to detect ‘fluctuations,’ ‘a rise,’ and/or ‘anomalies’ that might indicate illness or oestrus.” Id. at 16 (citing Ex. 1005, 121–122). Accordingly, Petitioner asserts that a “POSA would understand that to perform such analysis, the animal temperature information for each animal is necessarily stored in the” slip op. at 36

    • ExcludeMotion to exclude, deniedOther

      “Patent Owner moves to exclude Exhibits 1040, 1041, and 1044. Paper 36. We do not rely on any of Exhibits 1040, 1041, and 1044 to decide this matter. Thus we dismiss Patent Owner’s motion to exclude as moot.” slip op. at 82

    Patent outcomesUS 8,823,515 unpatentable
    § 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 8,823,515
  • 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
  • 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
  • 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
  • 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
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