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  • PTAB · Jan 14, 2026 · PGR2025-00059 · APJ Devon Zastrow Newman · PGR · Institution

    The Board instituted post-grant review of claims 1–4 on all four asserted grounds, finding a sufficient preliminary showing of obviousness and lack of enablement.

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

      “V. CONCLUSION Petitioner has, at this stage, established that it will more likely than not prevail in showing that at least one of the challenged claims is unpatentable. This determination is, however, based on a preliminary record and is not final on any issues of patentability. We will make a final determination on the patentability of the challenged claims, as necessary and applying the preponderance of the evidence standard, based on a fully developed record through trial. VI. ORDER In consideration of the foregoing, it is hereby: ORDERED that, pursuant to 35 U.S.C. § 324(a) post grant review of claims 1–4 of the ’233 patent is hereby instituted on the grounds set forth in the Petition, commencing on the entry date of this Order, and pursuant to 35 U.S.C. § 324(d) and 37 C.F.R. § 42.4, notice is hereby given of the institution of a trial; and” slip op. at 40

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Patent Owner does not proffer a description of a POSA. See generally, Prelim. Resp. For the purposes of this decision, on the record at this time, we find that Petitioner’s definition appears consistent with the level of skill shown in the prior art references of record, and apply it herein. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). We invite the parties to further address the definition of a POSA during trial should they find it necessary.” slip op. at 7

    • Expert testimonyPetitioner expert discountedDecided for patent owner

      “In addition, the opinion stated in the Pomper Declaration that “the term of ‘low molecular weight’ is well accepted in the chemical arts” and the declarant “recognize[s] that low molecular weight compounds would have a molecular weight of typically from about 50 Daltons to about 1,500 Daltons” is offered by a co-inventor. We, as factfinder, have discretion to weigh the credibility of expert witnesses and to give each item of evidence such weight as appropriate. See In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”). In this case, we find that the published references on metabolites do not support the opinion. In re Am. Acad. of Sci. Tech Ctr., 367 F.3d at 1368 (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”) US-121, of which Dr. Pomper is lead inventor, also uses the term “low molecular weight”—without further characterization of the term—and is uninformative as to the meaning of the term. See Ex. 1006, ¶ 12. In addition, Patent Owner’s definition does not appear to apply to all compounds claimed in US-121.5” slip op. at 11

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

      “limited to Patent Owner’s proposed “from about 50 Daltons to about 1,500 Daltons.” The cited evidence relied on in the Pomper Declaration to define “low molecular weight” as a term well accepted in the chemical arts relates to metabolomics and metabolites. See Ex. 1002, 169, (specifically, ¶ 17 of Dr. Pomper’s declaration). Patent Owner admits that Dr. Pomper’s testimony is about molecules that differ from the claimed imaging and radiotherapeutic agents targeting FAP-α, but argues that the testimony is still relevant for purposes of explanation. Prelim Resp. 21. While it may be relevant, the testimony is not persuasive in light of the Specification. We find the uncontested fact that several of the B moieties alone—without the A moiety or L linker—specifically identified in the ’233 patent fall outside of Patent Owner’s proposed definition persuasive, as we normally do not interpret claim terms in a way that excludes examples disclosed in the specification. See, e.g., Verizon Servs. Corp. v. Vonage Holdings Corp., 503 F.3d 1295, 1305 (Fed. Cir. 2007) (rejecting proposed claim interpretation that would exclude disclosed examples in the specification). The cases cited by Patent Owner supporting that a claim term may be construed to exclude embodiments where the prosecution history supports such construction are factually distinguishable from the instant case as they regard instances of specific prosecution history disclaimer, clear prosecution disavowal, or relate to a specific definition of the terms in the Specification for the term being construed. Here, “low molecular weight” is not defined in the Specification, but, as Petitioner argues (see Pet. 21–25) is characterized as “demonstrat[ing] faster pharmacokinetics and a higher specific signal within clinically convenient times after administration” and that it “can be synthesized in radiolabeled form more easily.” Ex.1001, 13:33–50, 14:56– 16:14, 17:9–20. We are persuaded by the testimony of Dr. Zeglis, Petitioner’s declarant, that compounds weighing over 1500 Da may share those same behaviors, along with certain identified B moieties disclosed as embodiments. See Ex. 1003 ¶ 83.” slip op. at 10

    Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
    Patents in suitUS 12,115,233
  • PTAB · Dec 18, 2025 · IPR2025-01071 · APJ Benjamin D M Wood · IPR · Institution

    The Board instituted IPR of claims 1–7, 12, 14, and 25 because Petitioner showed a reasonable likelihood of prevailing on its § 103 obviousness challenge over Bassompiere.

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

      “We have authority under 35 U.S.C. § 314, which provides that an inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). On the preliminary record before us, we determine that Petitioner has satisfied this threshold requirement, and therefore we institute inter partes review of claims 1–7, 12, 14, and 25 of the ’687 patent.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Patent Owner does not offer any reason why we should deviate from the Board’s determinations in the prior IPRs that one of ordinary skill in the art would have had knowledge of Kalman filters and quaternion mathematics. Nor are we aware of any such reason. On the contrary, the Board’s prior determinations are consistent with the level of ordinary skill reflected by prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978). Bassompiere, for example, teaches using a data merging algorithm that is, “[a]dvantageously,” extended Kalman filtering. Ex. 1006, 4:17. Bassompiere also teaches using quaternions to determine a device’s pitch and roll about a horizontal reference frame. Id. at 6:3–8, 20:10–21:1. Patent Owner argues that Dr. Sarrafzadeh’s testimony regarding the level of skill in the art in this proceeding contradicts his testimony in the prior IPRs, which did not include knowledge of Kalman filters and quaternion mathematics in his definition of the level of ordinary skill in the art. Prelim. Resp. 24–26. Patent Owner asserts that this contradiction “undermin[es] his credibility.” Id. at 26. We disagree. The testimony Dr. Sarrafzadeh provided in the earlier IPRs obviously preceded the Board’s determinations in those proceedings that, on the whole record, including the testimony of then-Patent Owner’s declarant, the level of ordinary skill included knowledge of Kalman Filters and quaternions. Dr. Sarrafzadeh’s testimony in this proceeding reasonably aligns with those determinations. Accordingly, we adopt Petitioner’s definition of the level of ordinary skill in the art for purposes of this Decision.” slip op. at 12

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

      “The parties agree that the claimed “spatial reference frame” is associated with a device, has its origin at the same point in the device, and has axes that are always fixed with respect to the device. The only disagreement is whether that device is a “3D pointing device” or an “electronic device.” The Specification indicates that “electronic device” encompasses 3D pointing devices as well as, e.g., smartphones and navigation equipment, and therefore is the broader term. Ex. 1001, 13:20– 23. At this stage of the proceeding, we determine that the threshold question of institution can be decided under either construction, because Patent Owner does not dispute that the primary asserted reference, Bassompiere, teaches a “spatial reference frame” associated with a 3D pointing device. Pet. 25–27. Therefore, at this stage of the proceeding, we decline to resolve the parties’ dispute. See Vivid Techs., Inc. v. Am. Sci. & Eng'g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those [claim] terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”); Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (approving Board decision not to construe claim language where the construction is not material to the dispute). 2. “predicted axial accelerations” Petitioner does not propose a construction for “predicted axial accelerations,” but, in the concurrent California Litigation, contends that it should be accorded its “plain and ordinary meaning.” Ex. 2007, 3. In subsequent briefing that will be discussed more fully below, Petitioner asserts that its declarant, Dr. Sarrafzadeh, “applied the ‘plain and ordinary’ meaning for all claim terms, including the ‘predicted axial accelerations’ term,” in this proceeding. Paper 14, 1. Petitioner also submits in that briefing that “the term ‘axial acceleration’ (whether predicted or measured) . . . ordinarily encompasses three types of acceleration,” i.e., “linear, centrifugal, and gravitational.” Id. at 3, 4. Patent Owner contends that “predicted axial accelerations” should be construed as “[g]ravitational acceleration along the electronic device’s axes derived from the current quaternion.” Prelim. Resp. 18. Patent Owner asserts that “[t]he claims and specification consistently define ‘predicted axial accelerations’ as gravitational accelerations along the device’s axes at time T, derived from the current quaternion.” Id. (citing Ex. 1001, claim 1, 17:18–30, 17:45–52). Patent Owner further submits that “because ‘predicted axial accelerations’ are computed from the current quaternion they only contain gravitational accelerations along the device’s axes.” Id. at 19 (citing Ex. 2023 ¶ 23). Here too, the threshold question of institution can be decided without” slip op. at 14

    • BurdenDecided for petitioner

      “We disagree with Patent Owner’s characterization. The teaching to use quaternions instead of Euler angles comes from Bassompiere, not Dr. Sarrafzadeh. See Ex. 1006, 20:10–11 (“A first variant embodiment consists in replacing the angles of torsion θ and ψ by a quaternion formulation of the same torsion.”). Rather than supplying a missing limitation, we understand Dr. Sarrafzadeh to be explaining how a person of ordinary skill in the art would have implemented Bassompiere’s teaching to use quaternions instead of Euler angles given that person’s knowledge of quaternion mathematics. Patent Owner also argues that “switching from Euler angles to quaternions is not a routine substitution but requires the reengineering of the EKF.” Prelim. Resp. 28. Patent Owner similarly contends that Dr. Sarrafzadeh “devotes nearly twenty pages of his declaration to rewriting Bassompiere’s Euler-based equations ‘in quaternion form,’ and explaining how to convert them back to Euler angles,” and notes that “[a]s other researchers in the field have confirmed, ‘[w]hile implementing orientation tracking using quaternions provides advantages like avoiding gimbal lock, it is significantly more complex than the Kalman filer using Euler angles.’” Prelim. Resp. 32 (citing Ex. 1002, 31–51; quoting Ex. 2027, 1). Patent Owner thus contends that replacing Euler angles with quaternions “is not a ‘trivial’ substitution.” Id. at 32. But Petitioner does not appear to be arguing that replacing Euler angles with quaternions would have been “trivial” or simple, only that doing so was taught by Bassompiere and within the knowledge and capabilities of a person of ordinary skill in the art. Pet. 33–34. We determined above that a skilled artisan had knowledge of extended Kalman filters and quaternion mathematics, and we are required to consider the knowledge and capabilities of a person of ordinary skill in our analysis. Further, at this preliminary stage, Patent Owner’s assertion that the Euler angle/quaternion switch would not have been a routine substitution is supported only with attorney argument, which is entitled to no weight. Icon Health & Fitness, Inc. v. Strava, Inc. 849 F.3d 1034, 1043 (Fed. Cir. 2017). As such, it does not outweigh Dr. Sarrafzadeh’s contrary testimony. See, e.g., Ex. 1002 ¶ 56.” slip op. at 29

    Claim constructioncites Phillips · KSR · Graham
    Patents in suitUS 11,698,687
  • PTAB · Dec 17, 2025 · IPR2025-01023 · APJ Benjamin D M Wood · IPR · Institution

    The Board instituted IPR on all asserted grounds against claims 1, 3, 7, and 9, finding a reasonable likelihood that Petitioner would prevail on at least one challenged claim.

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

      “c. Conclusion as to Claim 1 Having reviewed the record and the parties’ arguments, we determine that Petitioner has a reasonable likelihood of prevailing with respect to claim 1, and therefore has satisfied the threshold requirement for institution of inter partes review on the basis of Ground 1. 3. Claims 3, 7, and 9 Petitioner contends that Bassompiere teaches the limitations of claim 3, 7, and 9, and supports its contentions with citations to Bassompiere and to Dr. Sharrafzadeh’s declaration. Pet. 57–63. At this stage of the proceeding, Patent Owner does not raise any arguments specifically directed to these claims. “When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.” 37 C.F.R. § 42.108(a). We must “either (1) institute as to all claims challenged in the petition and on all grounds in the petition, or (2) institute on no claims and deny institution.” CTPG at 5–6, 64; see also PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1359–60 (Fed. Cir. 2018) (stating a decision to institute is “a simple yes-orno institution choice respecting a petition, embracing all challenges included in the petition”). Thus, because we have decided to grant institution on Ground 1 with respect to claim 1, we must do the same for claims 3, 7, and 9.” slip op. at 38

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Patent Owner does not offer any reason why we should deviate from the Board’s determinations in the prior IPRs that one of ordinary skill in the art would have had knowledge of Kalman filters and quaternion mathematics. Nor are we aware of any such reason. On the contrary, the Board’s prior determinations are consistent with the level of ordinary skill reflected by prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978). Bassompiere, for example, teaches using a data merging algorithm that is, “[a]dvantageously,” extended Kalman filtering. Ex. 1006, 4:17. Bassompiere also teaches using quaternions to determine a device’s pitch and roll about a horizontal reference frame. Id. at 6:3–8, 20:10–21:1. Nasiri teaches that quaternions can be used to represent a device’s “orientation in space.” Ex. 1008, 30:27– 30. Patent Owner argues that Dr. Sarrafzadeh’s testimony regarding the level of skill in the art in this proceeding contradicts his testimony in the prior IPRs, which did not include knowledge of Kalman filters and quaternion mathematics in his definition of the level of ordinary skill in the art. Prelim. Resp. 24–26. Patent Owner asserts that this contradiction “undermin[es] his credibility.” Id. at 26. We disagree. The testimony Dr. Sarrafzadeh provided in the earlier IPRs obviously preceded the Board’s determinations in those proceedings that, on the whole record, including the testimony of then-Patent Owner’s declarant, the level of ordinary skill included knowledge of Kalman Filters and quaternions. Dr. Sarrafzadeh’s testimony in this proceeding reasonably aligns with those determinations. Accordingly, for the above reasons, we adopt Petitioner’s definition of the level of ordinary skill in the art for purposes of this Decision.” slip op. at 13

    • Expert testimonyPetitioner expert creditedDecided for petitioner

      “We disagree with Patent Owner’s characterization. The teaching to use quaternions instead of Euler angles comes from Bassompiere, not Dr. Sarrafzadeh. See Ex. 1006, 20:10–11 (“A first variant embodiment consists in replacing the angles of torsion θ and ψ by a quaternion formulation of the same torsion.”). Rather than supplying a missing limitation, we understand Dr. Sarrafzadeh to be explaining how a person of ordinary skill in the art would have implemented Bassompiere’s teaching to use quaternions instead of Euler angles given that person’s knowledge of quaternion mathematics. Patent Owner also argues that “switching from Euler angles to quaternions is not a routine substitution but requires the reengineering of the EKF.” Prelim. Resp. 28. Patent Owner similarly contends that Dr. Sarrafzadeh “devotes nearly twenty pages of his declaration to rewriting Bassompiere’s Euler-based equations ‘in quaternion form,’ and explaining how to convert them back to Euler angles,” and notes that “[a]s other researchers in the field have confirmed, ‘[w]hile implementing orientation tracking using quaternions provides advantages like avoiding gimbal lock, it is significantly more complex than the Kalman filer using Euler angles.’” Prelim. Resp. 32–33 (citing Ex. 1002, 31–51; quoting Ex. 2027, 1). Patent Owner thus contends that replacing Euler angles with quaternions “is not a ‘trivial’ substitution.” Id. at 33. But Petitioner does not appear to be arguing that replacing Euler angles with quaternions would have been “trivial” or simple, only that doing so was taught by Bassompiere and within the knowledge and capabilities of a person of ordinary skill in the art. We determined above that a skilled artisan had knowledge of extended Kalman filters and quaternion mathematics such knowledge, and we are required to consider the knowledge and capabilities of a person of ordinary skill in our analysis. Further, at this preliminary stage, Patent Owner’s assertion that the Euler angle/quaternion switch would not have been a routine substitution is supported only with attorney argument, which is entitled to no weight. Icon Health & Fitness, Inc. v. Strava, Inc. 849 F.3d 1034, 1043 (Fed. Cir. 2017). As such, it does not outweigh Dr. Sarrafzadeh’s contrary testimony. See, e.g., Ex. 1002 ¶ 56.” slip op. at 30

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

      “The parties agree that the claimed “spatial reference frame” is associated with a device, has its origin at the same point in the device, and has axes that are always fixed with respect to the device. The only disagreement is whether that device is a “3D pointing device” or an “electronic device.” The Specification indicates that “electronic device” encompasses 3D pointing devices as well as, e.g., smartphones and navigation equipment, and therefore is the broader term. Ex. 1001, 8:35–39. At this stage of the proceeding, we determine that the threshold question of institution can be decided under either construction, because Patent Owner does not dispute that the primary asserted reference, Bassompiere, teaches a “spatial reference frame” associated with a 3D pointing device. Pet. 30–31. Therefore, at this stage of the proceeding, we decline to resolve the parties’ dispute. See Vivid Techs., Inc. v. Am. Sci. & Eng'g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those [claim] terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”); Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (approving Board decision not to construe claim language where the construction is not material to the dispute).” slip op. at 15

    Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
    Patents in suitUS 10,852,846
  • 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 · Jun 9, 2025 · IPR2024-00240 · APJ Deborah Katz · IPR · Final written decision

    Claims 1–42 are unpatentable: claims 1–42 are anticipated by the MSR, and the Board also finds the challenged claims obvious over the MSR and cited combinations.

    RulingsFinal written decision
    • Skill levelSkill level board ownDecided for petitioner

      “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, 25:40–50, 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. Neither party directs us to evidence of the level of skill in the art beyond what we considered for institution of trial. In the Decision to institute trial, we determined that the level of skill in the art relevant to the claims of the ’393 patent is not limited to knowledge of and experience with conducting research relating to oncology or developing and conducting clinical trials. (See Dec. 8–9.) We determined that the level of skill also includes knowledge of and experience with treating colorectal 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. (See id.) Because the parties do not present additional evidence or argument, we maintain that determination.” slip op. at 9

    • Expert testimonyPetitioner expert creditedDecided for petitioner

      “what one of ordinary skill in the art would have known and understood at the relevant time. Specifically, Petitioner relies on the testimony of Alfred L. Neugut, M.D., Ph.D., M.P.H.3 (Ex. 1003) and Paul E. Oberstein, M.D. (Ex. 1150). Patent Owner relies on the testimony of Nils Lonberg, Ph.D. (Ex. 2001) and Richard Goldberg, M.D. (Ex. 2090).” slip op. at 8

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

      “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. We further agree that this relationship is different than the use of the term “after” in claims 7, 20, and 27, wherein patients must be treated with a different cancer therapy, and wherein the cancer must have later progressed for the treatment to be within the scope of these claims. (Ex. 1001, 25:66–7, 26:44–46, 26:63–64.) 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 12

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

      “Microsatellite Unstable (MSI) Tumors.” (Ex. 1005, 2.) The parties’ witnesses agree that MK-3475 is pembrolizumab, the compound recited in claim 1. (See Neugut Decl., Ex. 1003 ¶ 37; see Lonberg Decl., Ex. 2001, ¶ 65.) Patent Owner does not dispute Petitioner’s assertion that the MSR was published on a government web site on June 10, 2013, more than two years before the priority date of the ’393 patent on July 10, 2015. (See Pet. 7 (citing Ex. 1005, 3, Ex. 1003 ¶ 35).)” slip op. at 17

    Patent outcomesUS 11,591,393 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,591,393
  • PTAB · May 20, 2025 · IPR2025-00125 · APJ Devon Zastrow Newman · IPR · Institution

    The Board denied institution because Petitioner did not show a reasonable likelihood that any challenged claim was unpatentable under the asserted obviousness grounds.

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

      “review. 35 U.S.C. § 314(b) (2018); 37 C.F.R. § 42.4(a) (2019). 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.” 35 U.S.C. § 314(a). Upon consideration of the Petition, the Preliminary Response, and the evidence of record, we conclude that Petitioner has not established a reasonable likelihood of prevailing on its assertion that at least one challenged claim is unpatentable based on the grounds advanced here. Accordingly, we deny institution of inter partes review of claims 1–20 of the ’967 patent.” slip op. at 2

    • Skill levelSkill level petitioner adoptedOther

      “VSI Int’l Inc., 174 F.3d 1308, 1324 (Fed. Cir. 1999) (citing Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966); Ryko Mfg. Co. v. Nu-Star, Inc., 950 F.2d 714, 718 (Fed. Cir. 1991)). Petitioner adopts the following definition of a person of ordinarily skill in the art (hereafter, sometimes “POSITA”) of the ’967 patent proposed by Patent Owner in the Avery Dennison litigation: [A]t least a bachelor’s degree in electrical engineering, computer science, or computer engineering, or a related discipline, and at least five years of experience which would consist of, A, designing, developing, evaluating and/or using RFID or other AIDC [automatic identification and data capture] technologies in inventory management, unique object identification, and/or security; or B, studying and conducting research related to RFID technologies and using RFID and other AIDC technologies in inventory management, unique object identification, and/or security. Pet. 6 (citing Ex. 1030, 707:3–13). Patent Owner does not offer a definition of an ordinarily skilled artisan of the ’967 patent at this time. See generally Prelim. Resp. Based on the information presented, we find that the asserted prior art itself is sufficient to demonstrate the level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (prior art itself can reflect the appropriate level of ordinary skill in the art). To the extent a more precise definition is required, we apply Petitioner’s unopposed proposed definition for purposes of determining whether to institute review because it is consistent with the disclosures of the asserted prior art references and the problems addressed in the ’967 patent.” slip op. at 17

    • Prior constructionPrior construction adoptedDecided for patent owner

      “Petitioner proposes the following claim constructions: “an allocated block of serial numbers” as “a pre-authorized range of binary serial numbers” and “uniquely corresponding” as the “term’s plain and ordinary meaning, consistent with the articulation of the plain and ordinary meaning” in the Avery Dennison litigation. Pet. 8–12. As to the remaining claim terms, Petitioner applies the district court’s constructions in the Avery Dennison litigation. Id. at 12 (citing Ex. 1028). Patent Owner applies the following constructions that were entered during in the Avery Dennison litigation: “object class information space” as “data field within the memory of the RFID integrated circuit chip for information identifying the class of an object, such as a company prefix, item reference code, partition value, and/or filter value,” “unique serial number space” as “data field within the memory of the RFID integrated circuit for information identifying a unique serial number,” “being assigned a limited number of most significant bits” as “includes a limited, predefined sequence at the leading end,” “remaining bits of lesser significance” as “the remaining lower order bits at the trailing end,” “is encoded with one serial number instance” as “has stored within it one serial number instance,” “an allocated block of serial numbers” as “a pre-authorized range of serial numbers,” and “uniquely corresponding” as its plain and ordinary meaning. Prelim. Resp. 32. For purposes of resolving whether to institute trial, we adopt and apply the interpretations stated in the district court’s claim construction order and applied by the Federal Circuit on appeal, Ex. 1028.11 See 55 F.4th 900, 908–909, 912–913 (Fed. Cir. 2022) (citing the district court’s claim construction order).” slip op. at 18

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

      “IBM200 and Kuhno would have made it obvious for a POSITA to commission RFID tags with unique serial numbers partitioned into MSBs and bits of lesser significance. See Pet. 34–39; Ex. 1005 ¶¶ 167–176. However, on this record, Petitioner has not sufficiently shown that the POSITA, having read IBM200 and Kuhno, would have been led to create a serial number space in which the limited number of “most significant bits” uniquely corresponds to those bits assigned to an allocated block of serial numbers, as recited in limitation [f].” slip op. at 25

    Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
    Patents in suitUS 9,798,967
  • PTAB · May 1, 2025 · IPR2025-00136 · APJ Jeffrey N Fredman · IPR · Institution

    Institution of inter partes review was denied for claims 1–10 because Petitioner did not establish a reasonable likelihood of prevailing on any asserted ground.

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

      “Accordingly, we find that on the current record Petitioner has not shown that it has a reasonable likelihood that it would prevail on these obviousness grounds. XII. DISCRETIONARY DENIAL – 35 U.S.C. § 325(d) In view of our determination that the Petitioner does not meet the threshold for instituting review on the merits, we need not address the parties’ dispute about whether the Board should exercise its discretion to deny institution under 35 U.S.C. § 325(d). Pet. 74–75; Prelim. Resp. 38–54; Pet. Reply 1–5; PO Sur-Reply 1–5. XIII. CONCLUSION After reviewing the information presented in the Petition and the Preliminary Response, we determine that, based on the evidence of record, Petitioner has not established a reasonable likelihood that claims 1–10 of the ’841 patent are unpatentable. XIV. ORDER Accordingly, it is ORDERED that, pursuant to 35 U.S.C. § 314(a), institution of an inter partes review of all challenged claims on all grounds presented in the Petition is denied.” slip op. at 35

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableInherency not foundNot shown unpatentable

      “However, neither Petitioner nor Dr. Jansky provide specific data on the record before us showing the actual measured homozygosity of either of the inbred lines, US-W 5309 and US-W 5315. And Phumichai experimentally demonstrates that Dr. Jansky’s assumption that theoretical heterozygosity reduction of 50% per generation is not necessarily accurate, stating the “observed average percentage of reduction of heterozygosity per generation (38.4% or 38.5%) was lower than the theoretically expected value of 50%.” Ex. 1005, 982. Indeed, Phumichai disclosed that the “SOPH [Section-based observed percentage of heterozygosity] decreased steadily from the original 100% in 99H2–1 (S0) to the family means of 62.4% in 3H2 (S1), 37.9% in 3H3 (S2).” Id. at 981. That is, Phumichai experimentally shows that in an S2 generation of a potato line, the heterozygosity was 37.9%, resulting in homozygosity of about 62.1%, below the 75% theoretically expected and the 75% required by claim 1 of the ’841 patent. Therefore, the evidence of record does not show that the S2 generation of potato lines in Jong necessarily satisfies the homozygosity recitation in claim 1 of the ’841 patent, and so cannot establish on the record before us that Jong inherently teaches this limitation.” slip op. at 15

    • Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia outweighedNot shown unpatentableNot shown unpatentable

      “Owner is telling. Petitioner does not refute Patent Owner’s evidence of objective indicia. On the current record, the objective indicia evidence is compelling. As to long felt need, Patent Owner cited evidence on record before the Examiner that showed a persistent need recognized by ordinarily skilled artisans. In re Gershon, 372 F.2d 535, 538 (CCPA 1967). For example, Dr. Huang states “This research is the breakthrough we have been waiting for since nearly a century . . . This is crucial for the potato breeding worldwide.” Ex. 2009, 687. There is no evidence that this long-felt need was satisfied by another before Appellant’s invention. See Newell Companies, Inc. v. Kenney Mfg. Co., 864 F.2d 757, 768 (Fed. Cir. 1988) (“[O]nce another supplied the key element, there was no long-felt need or, indeed, a problem to be solved . . . .”). Lastly, Dr. Lindhout explains that this invention satisfies the long-felt need, stating “I have discovered, and disclosed in the present application for patent, how a fertile homozygote in” slip op. at 33

    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsNot reached

      “XII. DISCRETIONARY DENIAL – 35 U.S.C. § 325(d) In view of our determination that the Petitioner does not meet the threshold for instituting review on the merits, we need not address the parties’ dispute about whether the Board should exercise its discretion to deny institution under 35 U.S.C. § 325(d). Pet. 74–75; Prelim. Resp. 38–54; Pet. Reply 1–5; PO Sur-Reply 1–5.” slip op. at 35

    Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
    Patents in suitUS 11,140,841
  • PTAB · Apr 9, 2025 · IPR2023-01374 · APJ Benjamin D M Wood · IPR · Final written decision

    Claims 37–45 are unpatentable as obvious over Watters; the Board also found claims 37, 40, and 43 obvious over Nohara and did not reach the remaining grounds.

    RulingsFinal written decision
    • Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableUnpatentable

      “First, Watters teaches that the relevant distance moved is relative to “the last GPS update,” with the “last GPS update” referring to the “first fix” acquired in step 1200. See Ex. 1005, 22:57–60; id. at 2:39–49 (“first fix” means initial position determined by GPS). Watters thus teaches that the starting point for the step 1230 inquiry regarding distance moved is based on information acquired in step 1200. Although Watters does not go on to expressly teach determining how far the device has moved away from the step 1200 GPS fix by comparing that GPS fix with the cellular-network-based position acquired in step 1220, it strongly suggests doing so by teaching acquiring the cellular-network position in the very same process that requires both determining how far the device has moved and the starting point (the GPS fix) for that determination. See In re Baird, 16 F.3d 380, 383 (Fed. Cir. 1994) (a “reference must be considered not only for what it expressly teaches, but also for what it fairly suggests.”). In other words, by teaching acquiring information that can be used to determine distance moved, and then teaching determining distance moved, Watters strongly suggests using the already-acquired information to perform the distance-moved calculation.” slip op. at 20

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

      “teaching acquiring the cellular-network position in the very same process that requires both determining how far the device has moved and the starting point (the GPS fix) for that determination. See In re Baird, 16 F.3d 380, 383 (Fed. Cir. 1994) (a “reference must be considered not only for what it expressly teaches, but also for what it fairly suggests.”). In other words, by teaching acquiring information that can be used to determine distance moved, and then teaching determining distance moved, Watters strongly suggests using the already-acquired information to perform the distance-moved calculation.” slip op. at 21

    • Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)Term construed petitioner constructionDecided for petitioner

      “limitation under 35 U.S.C. § 112(f). Pet. 8 (citing Williamson v. Citrix Online, LLC, 792 F.3d 1339, 1348 (Fed. Cir. 2015)). Petitioner asserts that the recited function is “determining when said embedded GPS module should be powered on, said embedded GPS module then being powered on dependent on at least one of a current radio position and a position error of said mobile device determined from the wireless communications network, said wireless communications network being different from said GPS.” Id. at 10–11. Petitioner further asserts that the structure disclosed in the ’206 patent corresponding to this function is a “CPU or other processing unit programmed with a thresholding algorithm to determine when to power on said embedded GPS module based on comparing at least one of a position and position error to one or more thresholds, and equivalents.” Id. Patent Owner “does not dispute Petitioners’ identified recited function and corresponding structure for this term.” PO Resp. 15. We adopt the parties’ agreed-upon construction for the above term.” slip op. at 10

    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner

      “Superguide did not, however, establish a per se rule that a limitation containing the phrase “at least one of” followed by “and” should be read conjunctively.9 For example, courts and the Board “have found SuperGuide 8 Although Petitioner asserts that we need not resolve this question, we note that Petitioner’s proposed ground of unpatentability based on Nohara is premised only on the disjunctive interpretation. See Pet. 46 (“Nohara teaches the claims under the ‘disjunctive’ interpretation.”). 9 See L.A. Biomed. Res. Inst. at Harbor-UCLA Med. Ctr. v. Eli Lilly & Co., 849 F.3d 1049, 1059 (Fed. Cir. 2017) (holding that the plain meaning of “an inapplicable when the listed items following ‘at least one of’ are not categories containing many possible values.” Apple, Inc. v. Evolved Wireless LLC, 2017 WL 6543970, at *4 (PTAB Dec. 20, 2017) (listing district court and Board decisions). We agree with this understanding of SuperGuide; for example, it would not make sense to say “at least one of ‘A’” if there was only one possible ‘A.’ Here, of course, there can be only one possible value for “current radio position.” The mobile device cannot be in two places at the same time. Further, we find nothing in the Specification of the ’206 patent to support the possibility of multiple values for “position error” associated with a single current radio position. Therefore, we interpret the claim term disjunctively; e.g., determining when the embedded GPS module should be turned on is dependent on current radio position or position error (or both).” slip op. at 11

    Patent outcomesUS RE48,206 unpatentable
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  • PTAB · Mar 24, 2025 · IPR2024-01235 · APJ Hubert C Lorin · IPR · Institution

    The Board instituted IPR of claims 1–3, 6–11, and 14–16 on all proposed grounds after finding a reasonable likelihood of prevailing on the §103 ground over Mañosa and Patel.

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

      “In an [inter partes 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), 815 F.3d at 1363 (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review). slip op. at 8

    • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedPrinted publication not establishedMixed

      “[T]here is no presumption in favor of institution or in favor of finding a reference to be a printed publication under § 42.108(c) or any other authority. . . . [T]he burden is on the petitioner to identify with particularity evidence sufficient to establish a reasonable likelihood that the reference was publicly accessible before the critical date of the challenged patent, and therefore that there is a reasonable likelihood that it qualifies as a printed publication.” slip op. at 20

    • Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languageDisclaimer not foundDecided for petitioner

      “May” expresses a possibility. The Specification reflects this interpretation of “may” when it states that “[i]n one embodiment, the organic material is not lyotropic. Thus, the organic material may not be a phospholipid.” Ex. 1001, 8:27–28 (emphasis added). One of ordinary skill would understand from this that the organic material “may not be” a phospholipid if the organic material is not lyotropic. It follows that if the organic material is lyotropic, then the organic material may be a phospholipid. Reading the statement “[t]he organic material may not be . . . a phospholipid” (id. at 8:59–63) in light of the earlier stated possibility that the organic material may be a phospholipid if the organic material is lyotropic, one of ordinary skill in the art would interpret “may not be” as excluding phospholipids under some conditions, not under all conditions. Taking the Specification’s discussion about phospholipids as exemplifying the permissive nature of the word “may,” we are unpersuaded that in stating that “[t]he organic material may not be [PMMA], a polyvinylidene difluoride-containing polymer, such as [PVDF] or PVDF- TrFE-CTFE, or a phospholipid, such as [DHPE]’” (Ex. 1001, 8:59–63), the specification “contains a clear and unmistakable disavowal of the compounds PMMA, PVDF, PVDF-TrFE-CTFE, and DHPE” and “disclaims the listed compounds” from the “organic material” of the claims under all conditions, as Patent Owner argues. Prelim. Resp. 6–7. Moreover, the claims themselves limit the “organic material” only to the extent that it is “barocaloric cooling or heating agent” and can perform in the manner claimed. See Ex. 1001, claim 1, supra. As broadly worded, the claims do not exclude PMMA, PVDF, PVDF-TrFE-CTFE, and DHPE per se from the group of organic materials employed by the claimed method. Adopting Patent Owner’s construction would impermissibly import a limitation (i.e., not exclude PMMA, PVDF, PVDF-TrFE-CTFE, and DHPE) into the claims. For the reasons stated, at this stage of the proceeding, we agree with Petitioner’s broad construction of “organic material.” We do not adopt Patent Owner’s proposed construction whereby PMMA, PVDF, PVDF- TrFE-CTFE, and DHPE are excluded from the scope of the claim term “organic material.” The parties are invited to address this issue further during trial, if desired. slip op. at 11

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

      “Petitioner shows that (a) Mañosa (i.e., inorganic compounds such as Ni-Mn-In, Gd5Si2Ge2, and La-Fe-Co-Si) and (b) Patel (i.e., PVDF-TrFE- CTFE) teach materials exhibiting inverse BCEs. Pet. 59 (citing, inter alia, Ex. 1007, pages 4–8; Ex. 1009, 1, 4–5; Ex. 1004 ¶ 108). In our view, at this stage, Petitioner sufficiently shows (via the five reasons listed supra) why it would have been obvious to one of ordinary skill in the art to substitute the barocaloric cooling or heating agent of Patel for that taught in Mañosa, thereby reaching the claimed method with a reasonable expectation of success. Cf. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (U.S., 2007) (“The Court recognized that when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.”)” slip op. at 32

    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,230,656
  • PTAB · Feb 3, 2025 · IPR2023-00958 · APJ Michael J Fitzpatrick · IPR · Final written decision

    Claims 1–28 are unpatentable as obvious: claims 1–12 and 19–28 over Linnarsson, McCloskey, and ordinary skill; claims 13–18 over those references plus McCloskey II.

    RulingsFinal written decision
    • ExcludeMotion to exclude, grantedMotion to exclude, deniedGranted in part

      “Clearly, the second Hall-Ellis declaration is offered to prove that McCloskey is a prior art printed publication. See, e.g., Ex. 1085 ¶50 (“In view of the foregoing, it is my opinion that [McCloskey] was publicly available no later than [January 3, 2008].”). Thus, the second Hall-Ellis declaration should have been served within ten business days of Patent Owner’s February 15, 2024, objection to the admissibility of McCloskey. See 37 C.F.R. § 42.64(b)(2) (“The party relying on evidence to which an objection is timely served may respond to the objection by serving supplemental evidence within ten business days of service of the objection.”). In its Opposition to the Motion to Exclude, Petitioner argues that, under Hulu LLC v. Sound View Innovations, LLC, No. IPR2018-01039, Paper 29 (Dec. 20, 2019) (precedential), it was allowed to wait until its Reply to file the second Hall-Ellis declaration. Paper 37, 2. The Board in Hulu does state that, “if the patent owner challenges a reference’s status as a printed publication, a petitioner may submit a supporting declaration with its reply to further support its argument that a reference qualifies as a printed publication.” Hulu, at 15 (37 C.F.R. § 42.23). However, the Board’s statement was referring to the scope of permissible reply arguments under 37 C.F.R. § 42.23(b). See Hulu at 14 (quoting 37 C.F.R. § 42.23(b)’s requirement that “[a] reply may only respond to arguments raised in the corresponding opposition, patent owner preliminary response, or patent owner response”). The Board in Hulu does not purport to interpret 37 C.F.R. § 42.64 or even discuss supplemental evidence. Petitioner clearly missed the deadline imposed by 37 C.F.R. § 42.64(b)(2), which was triggered by Patent Owner’s February 15, 2024, objection to McCloskey (i.e., Ex. 1004). Patent Owner’s Motion to Exclude is granted with respect to the second Hall-Ellis declaration (i.e., Ex. 1085).” slip op. at 18

    • Obviousness (§103) › Analogous artAnalogous artDecided for petitioner

      “Patent Owner is correct that, under Sanofi-Aventis, a petitioner bears the burden of persuasion to establish that an asserted prior art reference is analogous art to the claimed invention. See Sanofi-Aventis, 66 F.4th at 1377 (“We agree with [the patent owner] that [the petitioner] did not carry its burden to argue that de Gennes is analogous to the [challenged] patent.”); id. (“In evaluating whether a reference is analogous, we have consistently held that a patent challenger must compare the reference to the challenged patent.”); id. at 1378–79 (“We have routinely held that the petitioner has the burden of proving unpatentability.”). However, as we noted when instituting this proceeding, “Sanofi-Aventis further held: ‘A petitioner is not required to anticipate and raise analogous art arguments in its petition; instead a petitioner can use its reply to “respond to arguments raised in the corresponding opposition, patent owner preliminary response, patent owner response, or decision on institution.”’” Dec. on Reh’g 16 (quoting Sanofi- Aventis, 66 F.4th at 1379 (quoting 37 C.F.R. § 42.23)).” slip op. at 15

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

      “Clearly, the second Hall-Ellis declaration is offered to prove that McCloskey is a prior art printed publication. See, e.g., Ex. 1085 ¶50 (“In view of the foregoing, it is my opinion that [McCloskey] was publicly available no later than [January 3, 2008].”). Thus, the second Hall-Ellis declaration should have been served within ten business days of Patent Owner’s February 15, 2024, objection to the admissibility of McCloskey. See 37 C.F.R. § 42.64(b)(2) (“The party relying on evidence to which an objection is timely served may respond to the objection by serving supplemental evidence within ten business days of service of the objection.”). In its Opposition to the Motion to Exclude, Petitioner argues that, under Hulu LLC v. Sound View Innovations, LLC, No. IPR2018-01039, Paper 29 (Dec. 20, 2019) (precedential), it was allowed to wait until its Reply to file the second Hall-Ellis declaration. Paper 37, 2. The Board in Hulu does state that, “if the patent owner challenges a reference’s status as a printed publication, a petitioner may submit a supporting declaration with its reply to further support its argument that a reference qualifies as a printed publication.” Hulu, at 15 (37 C.F.R. § 42.23). However, the Board’s statement was referring to the scope of permissible reply arguments under 37 C.F.R. § 42.23(b). See Hulu at 14 (quoting 37 C.F.R. § 42.23(b)’s requirement that “[a] reply may only respond to arguments raised in the corresponding opposition, patent owner preliminary response, or patent owner response”). The Board in Hulu does not purport to interpret 37 C.F.R. § 42.64 or even discuss supplemental evidence. Petitioner clearly missed the deadline imposed by 37 C.F.R. § 42.64(b)(2), which was triggered by Patent Owner’s February 15, 2024, objection to McCloskey (i.e., Ex. 1004). Patent Owner’s Motion to Exclude is granted with respect to the second Hall-Ellis declaration (i.e., Ex. 1085). Despite the exclusion of the second Hall-Ellis declaration, there is ample evidence in the record demonstrating that McCloskey is a prior art printed publication. McCloskey itself states: “Received: 31 January 2007 / Accepted: 29 May 2007 / Published online: 23 October 2007.” Ex. 1004, 1. McCloskey additionally states that it was published in a 2007 print issue of “Biochem Genet,” with Petitioner adding that the full name of the journal is BIOCHEMICAL GENETICS and that McCloskey was published in a December 2007 volume of the journal. Id.; Pet. 22. McCloskey also includes a copyright notice by “Springer Science+Business Media, LLC” with a date of 2007. Ex. 1004, 1. Patent Owner argues that this is unreliable hearsay that should be excluded. PO Mot. To Exclude 4 (citing Neste Oil Oyj v. REG Synthetic Fuels, LLC, No. IPR2013-00578, Paper 53 at 5–7 (Mar. 12, 2015); Standard Innovation Corp. v. Lelo, Inc., No. IPR2014-00148, Paper 429 at 13–18, 21–22 (Apr. 23, 2015)). We are not persuaded by Patent Owner’s argument or its reliance on these cases. The facts before us are different.” slip op. at 18

    • Skill levelSkill level patent owner adoptedDecided for patent owner

      “Patent Owner does not directly dispute Petitioner’s proposal but does offer its own proposal. PO Resp. 21. Patent Owner proposes that the skilled artisan “would have had a Ph.D. in molecular biology, molecular genetics, biochemistry, physics, mechanical engineering, or a related discipline, with 7 Exhibit 1002 is a declaration by Petitioner’s witness, Gregory Cooper, Ph.D. two years of academic, research, or industry experience in the field of genomic or transcriptome sequencing.” Id. (citing Ex. 2013 ¶¶25–268). Both of the parties’ proposals as to the level of ordinary skill in the art are consistent with the disclosure of the ’013 patent and the asserted prior art. The distinction between the parties’ proposals would not change the outcome of this Decision. Thus, we adopt and apply Patent Owner’s proposal.” slip op. at 9

    Patent outcomesUS 10,697,013 unpatentable
    § 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 10,697,013
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