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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 · 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 · Mar 18, 2025 · IPR2024-01380 · APJ Richard H Marschall · IPR · Institution

    The Board instituted inter partes review of claims 1–10 based on a reasonable likelihood that the Polinski and Piepho combination renders claims 1–8 obvious.

    RulingsInstitution decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner argues that a person of ordinary skill in the art relating to the ’568 patent would have had “a bachelor’s degree in mechanical engineering or a related field, and at least 2 years of experience with industrial equipment design and development.” Pet. 5 (citing Ex. 1002 ¶ 30). Petitioner also contends that one of ordinary skill “may also have a combination of more formal education and less work experience or a combination of less or different formal education and more work experience.” Id. We view Petitioner’s definition as consistent with the problems and solutions disclosed in the ’568 patent and prior art of record, and adopt it as our own for purposes of this Decision. See, e.g., GPAC, 57 F.3d at 1579 (approving the determination of the level of ordinary skill in the art by appeal to the references of record).” slip op. at 7

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

      “standard set forth in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc). Under that standard, we give the words of a claim their plain and ordinary meaning as would have been understood by one skilled in the art at the time of the invention and in the context of the entire patent disclosure. Id. at 1312–13. Only terms in controversy need be construed, and only to the extent necessary to resolve the controversy. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Petitioner argues that “[n]o terms need construction because the claims read on the prior art identified below under any construction consistent with Phillips.” Pet. 14–15. Based on the record before us, we need not expressly construe any claim terms to resolve the issues presented at this stage of the proceeding.” slip op. at 7

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

      “Based on the current record, Petitioner sufficiently establishes for the purposes of institution that one of ordinary skill in the art would have been motivated to combine Piepho and Polinski in the manner Petitioner proposes and further demonstrates that the combination discloses all of the limitations of claim 1. 3. Conclusion Based on the foregoing, Petitioner establishes a reasonable likelihood of proving that the combination of Piepho and Polinski renders claim 1 obvious. We have also reviewed Petitioner’s arguments addressing claims 2–8. See Pet. 31–40. Based on our review of the current record, Petitioner also establishes a reasonable likelihood of proving that claims 2–8 would have been obvious over Piepho and Polinski.” slip op. at 14

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

      “and Piepho renders claim 1 obvious. For each limitation in claim 1, Petitioner points to specific portions of the references that support its position that the combination discloses the limitations in question. See Pet. 16–31. Petitioner also cites to declarant testimony addressing the limitations. Id. (citing Ex. 1002). In support of its combination of Polinski and Piepho, Petitioner argues that both references disclose “gyratory rock crusher[s],” “Piepho further teaches the interchangeability between a cylindrical joint and a tapered joint,” and one of ordinary skill in the art (a “POSITA”) would have been motivated to combine Piepho’s tapered joint with Polinski. Id. at 16–17 (citing Ex. 1002 ¶¶ 80–81; Ex. 1015, 1010; Ex. 1016, 3:24–35). According to Petitioner, “Piepho teaches the interchangeability between a cylindrical joint and a tapered joint” and “a POSITA would understand the advantages afforded by the use of a tapered joint as compared with a cylindrical joint,” including the fact that “tapered interference joints, while more expensive to manufacture, provide[] advantages in assembly, alignment, and fit-up.” Id. at 17 (citing Ex. 1002 ¶¶ 80–81).” slip op. at 11

    Claim construction§ 103 obviousnesscites Phillips
    Patents in suitUS 9,827,568
  • PTAB · Mar 18, 2025 · IPR2024-01381 · APJ Richard H Marschall · IPR · Institution

    The Board instituted review of claims 1–14 based on a reasonable likelihood that the Polinski, Piepho, and Harless combination renders claim 1 obvious.

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

      “We have jurisdiction under 35 U.S.C. § 314. Under § 314, 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 challenged claims in the petition.” 35 U.S.C. § 314(a). Because we determine that Petitioner demonstrates a reasonable likelihood that at least one challenged claim is unpatentable, we institute an inter partes review of all claims as challenged in the Petition.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner argues that a person of ordinary skill in the art (“POSITA”) relating to the ’090 patent would have had “a bachelor’s degree in mechanical engineering or a related field, and at least 2 years of experience with industrial equipment design and development.” Pet. 3 (citing Ex. 1002 ¶ 29). Petitioner also contends that one of ordinary skill “may also have a combination of more formal education and less work experience or a combination of less/different formal education and more work experience.” Id. Patent Owner states that, for purposes of its Preliminary Response, it “does not object to Petitioner’s position on the level of ordinary skill in the art.” Prelim. Resp. 21 (citing Ex. 2001 ¶ 27). At this stage, and based on Petitioner’s undisputed contentions, we view Petitioner’s definition as consistent with the problems and solutions disclosed in the ’090 patent and prior art of record, and adopt it as our own for purposes of this Decision. See, e.g., GPAC, 57 F.3d at 1579 (approving the determination of the level of ordinary skill in the art by appeal to the references of record).” slip op. at 6

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

      “Pursuant to 37 C.F.R. § 42.100(b), we apply the claim construction standard set forth in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc). Under that standard, we give the words of a claim their plain and ordinary meaning as would have been understood by one skilled in the art at the time of the invention and in the context of the entire patent disclosure. Id. at 1312–13. Only terms in controversy need be construed, and only to the extent necessary to resolve the controversy. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Petitioner argues that “[n]o terms need construction because the claims read on the prior art identified below under any construction consistent with Phillips.” Pet. 10–11. Patent Owner “submits that the Board need not construe any claim terms as the claims are patentable under any reasonable construction.” Prelim. Resp. 20. Based on the record before us, we need not expressly construe any claim terms to resolve the issues presented at this stage of the proceeding.” slip op. at 7

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

      “Patent Owner does not contest Petitioner’s combination of Polinski and Piepho, but instead argues that no motivation to combine exists because Harless “would render both Polinski and Piepho inoperable for their intended purpose of preventing shaft failure.” Prelim. Resp. 22–31 (citing, inter alia, Ex. 2001 ¶¶ 48–59). When addressing intended purpose, Patent Owner argues that “Polinski mitigates shaft fatigue failure . . . specifically by omitting threads that are typically cut into gyratory shafts to attach a crusher mantle.” Id. at 23 (citing Ex. 1017, 1:61–67). Patent Owner asserts that Polinski instead teaches that shaft stress can be reduced “by cutting threads into a bearing sleeve.” Id. at 24 (citing Ex. 1017, 1:1–67). Piepho, according to Patent Owner, seeks a similar goal: “to prevent fretting wear and corresponding fatigue,” by “coating a portion of the shaft fit into a yoke bushing (which Petitioner alleges is a sleeve) with a ceramic coating.” Id. at 24 (citing Ex. 1007, 2:15–25; Ex. 2001 ¶¶ 42–43). Patent Owner argues that introducing Harless’s groove onto the main shaft would undermine the purposes of Piepho and Polinski because these would “introduce stress concentrations,” “lead to increased fretting wear,” and “increase the likelihood of fatigue failure.” Id. at 24–29. Patent Owner also argues that Petitioner’s approach relies on impermissible hindsight because one of ordinary skill would not seek to rely on Harless’s grooved shaft for use in “mounting of gears and similar components” rather than “for crushing applications, much less in a gyratory crusher, as claimed.” Id. at 30. According to Patent Owner, Harless fails to disclose “that its shaft is subjected to the same substantial stresses generated by the cyclic loading as the shafts disclosed by Polinski and Piepho.” Id. As to Petitioner’s argument that a POSITA would be motivated to make the combination to simplify the equipment and process for interference fits, Patent Owner contends that “Petitioner impermissibly picks and chooses aspects of the three references” and ignores what they teach to a POSITA, namely that “Polinski and Piepho are both directed to mitigating shaft fatigue” and adding Harless’s oil groove introduces several problems, as noted above. Id. at 31 (citing Ex. 2001 ¶¶ 48–59). Based on the current record, Petitioner sufficiently establishes for the purposes of institution that one of ordinary skill in the art would have been motivated to combine Piepho, Polinski, and Harless in the manner Petitioner proposes. Notably, Patent Owner does not directly contest Petitioner’s stated reasons why a POSITA would be motivated to make the proposed combination, i.e., that the combination would save money and simplify the equipment and process for making and breaking interference fits. See Pet. 19–21; Prelim. Resp. 22–31. Patent Owner instead suggests that Petitioner improperly ignores disadvantages when adding Harless’s groove to Polinski and Piepho, which at best suggests a weighing between the advantages Petitioner contends the addition of Harless’s groove provides and the alleged disadvantages. See Prelim. Resp. 22–31. While Patent Owner’s arguments may ultimately prevail, given the highly factual nature of the competing expert testimony and the weighing necessary to resolve this issue, we view the issues as best resolved after further development during trial and after Petitioner has the opportunity to respond to Patent Owner’s arguments and evidence. On this record and at this stage of the proceeding, Petitioner’s arguments and supportive declarant testimony adequately establishes a motivation to combine the references.” slip op. at 17

    Claim construction§ 103 obviousnesscites Phillips
    Patents in suitUS 11,014,090
  • PTAB · Sep 27, 2024 · IPR2024-00649 · APJ Sheridan K Snedden · IPR · Institution

    The Board instituted IPR of claims 1–28 on all six asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.

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

      “To institute an inter partes review, we must determine that the information presented in the Petition shows “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) (2018). The Supreme Court has held that a decision to institute under 35 U.S.C. § 314 may not institute on less than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). After considering the information presented by the parties, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving that at least one of claims 1–28 of the ’187 patent are unpatentable.” slip op. at 2

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

      “Anticipation is a question of fact, as is the question of what a prior art reference teaches. In re NTP, Inc., 654 F.3d 1279, 1297 (Fed. Cir. 2011). “Because the hallmark of anticipation is prior invention, the prior art reference—in order to anticipate under 35 U.S.C. § 102—must not only disclose all elements of the claim within the four corners of the document, but must also disclose those elements ‘arranged as in the claim.’” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008) (quoting Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983)). Whether a reference anticipates a claim is assessed from the skilled artisan’s perspective. See Dayco Prods., Inc. v. Total Containment, Inc., 329 F.3d 1358, 1368 (Fed. Cir. 2003) (“[T]he dispositive question regarding anticipation [i]s whether one skilled in the art would reasonably understand or infer from the [prior art reference’s] teaching that every claim element was disclosed in that single reference.” (quoting In re Baxter Travenol Labs., 952 F.2d 388, 390 (Fed. Cir. 1991))).” slip op. at 9

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

      “The obviousness inquiry also typically requires an analysis of “whether there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (requiring “articulated reasoning with some rational underpinning to support the legal conclusion of obviousness”)). A petitioner cannot prove obviousness with “mere conclusory statements.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380 (Fed. Cir. 2016). Rather, a petitioner must articulate a sufficient reason why a person of ordinary skill in the art would have combined the prior art references. In re NuVasive, Inc., 842 F.3d 1376, 1382 (Fed. Cir. 2016).” slip op. at 10

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

      “Petitioner argues that we need not construe any terms of the challenged claims to resolve the issues presented in the Petition. Pet. 11. We determine that no express construction of any claim term is necessary to determine whether to institute inter partes review. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Matal, 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))). To the extent further discussion of the meaning any claim term is necessary to our decision, we provide that discussion below in our analysis of the asserted grounds of unpatentability.” slip op. at 8

    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,629,187
  • PTAB · Sep 27, 2024 · IPR2024-00650 · APJ Deborah Katz · IPR · Institution

    The Board instituted IPR of claims 1–38 on all asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.

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

      “Director determines that the information presented in the petition filed under section 311 and any response filed under section 313 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). We determine whether to institute an inter partes review on behalf of the Director. See 37 C.F.R. § 42.4(a).” slip op. at 2

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

      “determined to be microsatellite instability high or DNA mismatch repair deficient were placed into a study arm and then treated with pembrolizumab. (See Ex. 1005, Ex. 1003 ¶¶ 60–73.) Because treatment of the patients was performed only after MSI-H status was determined, the MSI-H Study Record teaches treating the patients “in response to” determining their MSI- H status.” slip op. at 15

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

      “have been expected, Petitioner cites to Brown as teaching that PD-1 inhibitors are inherently more effective when treating tumors comprised of cells that are easy for immune cells to recognize. (See Pet. 41 (citing Ex. 1034, 747).) Petitioner argues further that Duval teaches that MSI-H cancers have cells that are easy for immune cells to recognize. (See Pet. 41 (citing Ex. 1087, 5002).) Dr. Neugut’s testimony supports Petitioner’s argument that the cited teachings of Brown and Duval, as well as other references, would have motivated a person of ordinary skill in the art to obtain the results of the MSI-H Study Record. (See Ex. 1003 ¶¶ 124, 130, 132; see Pet. 41.) Petitioner argues further that Brown and Duval would have motivated one of ordinary skill in the art to obtain the results of the MSI-H Study Record by treating patients with common types of MSI-H cancers, including endometrial, small bowel, and gastric cancers. (See Pet. 41 (citing Ex. 1003 ¶ 130).) Petitioner argues further that the state of the art, as demonstrated by Brown and Duval, as well as other references, would have provided one of ordinary skill in the art with a reasonable expectation of success because physicians were successfully treating patients with cancers that were known to be MSI-H with PD-1 inhibitors. (See Pet. 42 (citing Ex. 1003 ¶¶ 131, 132).)” slip op. at 18

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner argues that one of ordinary skill in the art relevant to the ’219 patent would have been a medical doctor or a professional in a related field with at least five years of experience with treating cancer. (See Pet. 11 (citing Neugut Decl., Ex. 1003 ¶19).) Petitioner argues further that the ordinarily skilled artisan would have experience in or access to a person with knowledge of clinical studies for therapeutics and how they work and to a pathologist with comparable experience. (See id.) Dr. Neugut’s testimony supports Petitioner’s arguments regarding the level of skill that an ordinarily skilled artisan in the relevant field would have. (See Ex. 1003 ¶ 19.) Accordingly, in the analysis below, and in the absence of argument by Patent Owner to the contrary, we apply the level of skill set forth by Petitioner and refer to Dr. Neugut’s testimony of what one of ordinary skill in the art would have understood at the time the application that became the ’491 patent was filed, which does not appear to be inconsistent with the level of skill reflected in the asserted prior art.” slip op. at 8

    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,634,491
  • PTAB · Sep 23, 2024 · IPR2024-00624 · APJ Sheridan K Snedden · IPR · Institution

    The Board instituted IPR on claims 1–4, 6–10, and 12–15 on all petitioned grounds, finding a reasonable likelihood of success on at least one challenge and declining Fintiv denial.

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

      “To institute an inter partes review, we must determine that the information presented in the Petition shows “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) (2018). The Supreme Court has held that a decision to institute under 35 U.S.C. § 314 may not institute on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). After considering the information presented by the parties, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving that at least one of claims 1–4, 6–10, and 12–15 of the ’975 patent are unpatentable.” slip op. at 2

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

      “invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the . . . .” 35 U.S.C. § 102(a). To be anticipated, each and every element of the claim must be found, either expressly or inherently described, in a single prior art reference. See Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 999 (Fed. Cir. 2006). When claim elements are inherently taught, the result must be a necessary consequence of what was deliberately intended, but the prior art need not demonstrate that the authors appreciated the results. See Mehl/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1366 (Fed. Cir. 1999); see Schering Corp. v. Geneva Pharm., Inc., 339 F.3d 1373, 1377 (Fed. Cir. 2003) (“At the outset, this court rejects the contention that inherent anticipation requires recognition in the prior art.”).” slip op. at 9

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

      “Obviousness is determined by looking to the scope and content of the prior art, differences between the prior art and the claims at issue, and the level of ordinary skill in the pertinent art resolved. See Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 17–18 (1966). “[T]he analysis need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).” slip op. at 10

    • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner

      “pending Maryland litigation has been stayed in its entirety pending resolution of IPR2024-00240, which involves a related patent that is also involved in the litigation. Reply, 1 (citing Order in Maryland litigation, dated June 29, 2024, Ex. 1100, 1); see Sur-Reply, 1 (acknowledging “the recent stay of the parties’ co-pending litigation involving the ’975 Patent.”). In its Memorandum Opinion, the court acknowledged that inter partes reviews of additional patents involved in the litigation could be instituted. See Ex. 1101, 3. Accordingly, the first Fintiv factor weighs heavily in favor of not exercising discretion to deny institution of inter partes review. Because of the stay, the second and third Fintiv factors also weigh heavily in favor of not exercising discretion to deny institution of inter partes review. The stay indicates that the court’s trial date will not be close to the Board’s projected statutory deadline for a final written decision and that neither the court nor the parties will invest further in the parallel proceeding. See Fintiv, at 6 (“A district court stay of the litigation pending resolution of the PTAB trial allays concerns about inefficiency and duplication of efforts. This fact has strongly weighed against exercising the authority to deny institution under NHK.”); see also Memorandum Opinion in Maryland litigation issued June 29, 2024, Ex. 1101, 2 (noting that the” slip op. at 32

    Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · Graham
    Patents in suitUS 11,325,975
  • PTAB · Sep 20, 2024 · PGR2024-00018 · APJ Kevin W Cherry · PGR · Institution

    The Board instituted PGR on claims 1–15 and all petitioned grounds, finding a reasonable likelihood that claims 1–3, 6, and 10 are obvious over ElMasry.

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

      “Under 35 U.S.C. § 324(a), a post-grant review may be instituted only if “the information presented in the petition . . . demonstrate[s] that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” Post-grant review is available for patents that issue from applications that at one point contained at least one claim with an effective filing date on or after March 16, 2013. See Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284 (2011) (“AIA”), §§ 3(n)(1), 6(f)(2)(A). After considering the briefing and the evidence of record, for the reasons set forth below, we determine that Petitioner has shown that the ’947 patent is eligible for post-grant review, and has shown it is more likely than not that at least one challenged claim of the ’947 patent is unpatentable under § 324(a). Accordingly, we institute a post-grant review of the challenged claims of the ’947 patent.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner contends that a person of ordinary skill in the art “would have a B.S. degree in Electrical Engineering, Physics, Chemistry, or an equivalent field, and at least 2-3 years of academic or industry experience in engineering related to optical sorting systems.” Pet. 17 (citing Ex. 1009 ¶ 21). Patent Owner did not file a Preliminary Response to the Petition and, therefore, at this point, does not contest Petitioner’s definition for one of ordinary skill in the art. Petitioner’s proposed definition appears to be consistent with the disclosure of the ’947 patent, and we adopt it for purposes of this Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that the prior art itself may “reflect[] an appropriate level” of ordinary skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 11

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

      “Having considered the record, we determine that no express claim construction is necessary for any claim terms for the purposes of rendering a decision to institute trial. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (holding that only claim terms in controversy need to be construed, and only to the extent necessary to resolve the controversy (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). At this stage, we find it unnecessary to resolve whether “electronic control unit” and “processing module” should be construed as mean plus function limitations under § 112(f), because it is possible to address the obviousness grounds presented whether or not these limitations are so construed, and even if the claims were indefinite in the manner Petitioner contends. See Intel Corp. v. Qualcomm Inc., 21 F.4th 801, 813 (Fed. Cir. 2021) (noting indefiniteness of a means-plus-function limitation does not always render it impossible to adjudicate a prior-art challenge). We direct the parties to address the construction of these claim terms and Petitioner’s interpretation during trial.” slip op. at 13

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

      “We have reviewed Petitioner evidence and citations and, on the current record, we find that Petitioner has shown that it is more likely than not that ElMasry teaches all the limitations of claim 1, without need for any modification. Thus, we find that Petitioner has shown that it is more likely than not that claim 1 would have been unpatentable as obvious over ElMasry.” slip op. at 20

    Claim construction§ 103 obviousness§ 112 disclosure
    Patents in suitUS 11,666,947
  • PTAB · Sep 5, 2024 · IPR2023-01300 · APJ Devon Zastrow Newman · IPR · Institution

    The Board instituted IPR on claims 1–13 and all asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.

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

      “partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). The Board determines whether to institute a trial on behalf of the Director. 37 C.F.R. § 42.4(a). A decision to institute is “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition.” PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018). For the reasons set forth below, we determine that Petitioner has demonstrated that there is a reasonable likelihood that at least one of the challenged claims is unpatentable. Accordingly, we institute an inter partes review of the challenged claims in the Petition.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “would have possessed a strong understanding in the use and development of genetics and genomics approaches for detecting or monitoring human diseases, such as spatial detection of a target analyte (e.g., mRNA or DNA) in a tissue, and would typically have a Ph.D. in a relevant field (e.g., molecular biology, genetics, and bioinformatics) with two years of experience. Pet. 21–22 (citing Ex. 1044 ¶¶ 24–36). For the purposes of its Preliminary Response, Patent Owner does not provide its own proposed level of skill. Prelim. Resp. 7. For purposes of this Decision, we apply Petitioner’s unchallenged definition as it is consistent with the cited prior art and disclosure of the ’142 patent.” slip op. at 12

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

      “Thus, according to claim 1, to synthesize a first/second plurality of DNA products by performing a synthesis reaction, the “DNA products” must 1) use the oligonucleotides collected in steps (a) and (b) as templates from which the DNA is synthesized, and 2) incorporate a source location-identifying nucleic acid sequence.” slip op. at 20

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningDecided for petitioner

      “(2) Analysis Neither party has offered a construction for “collecting oligonucleotides under conditions that release them” in claim 1. We note that, in the related litigation, the district court determined that “under conditions that release” should have its plain and ordinary meaning. Ex. 1052, 38. For purposes of institution, we also apply the plain and ordinary meaning of this claim phrase and do not need to expressly construe the claim phrase for purposes of institution. On this record, for the reasons explained by Petitioner and as supported by its declarant testimony, we conclude Petitioner has sufficiently shown that So-456 discloses the “collecting oligonucleotides under conditions that release them” limitation recited in claim 1.” slip op. at 42

    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,473,142
  • PTAB · Aug 30, 2024 · IPR2022-01531 · APJ Devon Zastrow Newman · IPR · Remand

    On remand, the Board instituted inter partes review of claims 1–17, 20–21, 24–26, and 29–34 on all grounds stated in the Petition.

    RulingsRemand decision
    • Director reviewOther

      “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 (“Inst. Dec.”). Petitioner requested Director review of our decision denying institution (Paper 18 (“Request”)). The Director delegated review of the decision to a Delegated Rehearing Panel. Paper 19. Patent Owner was granted the option to file a response to Petitioner’s Request (Paper 22 (“Request Resp.”)). The Director Review Panel (“DRP”) vacated our decision and remanded the case to this panel with a revised construction for claim 1. Paper 23 (“DRP Dec.”).” slip op. at 2

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

      “An inter partes review may be instituted only if “the information presented in the petition . . . and any [preliminary] response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect (2018). Upon reconsideration of the briefing and the evidence of record in light of the DRP’s claim construction, we conclude that Petitioner has established a reasonable likelihood of prevailing on its assertion that at least one of the challenged claims is unpatentable. Accordingly, we grant institution of inter partes review of claims 1–17, 20–21, 24–26, and 29–34 of the ’682 patent.” slip op. at 2

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

      “We find that Petitioner has demonstrated a material error by the Office in the prior consideration of Morales-Sanfrutos, Straus, Singh, and Lees. For instance, under the second prong of Advanced Bionics, we consider “(c) the extent to which the asserted art was evaluated during “(e) whether Petitioner has pointed out sufficiently how the Examiner erred in its evaluation of the asserted prior art.” Becton, Dickinson, 17–18. We agree with Petitioner that the Office overlooked Morales- Sanfrutos’ and Singh’s teachings during examination and reexamination. Pet. 79. Although Morales-Sanfrutos, Straus, and Singh were listed on an IDS, they were not the subject of a rejection during examination or reexamination. Moreover, for the reasons discussed below at this stage with regard to Petitioner’s grounds over Morales-Sanfrutos, as evidenced by Straus, and over Singh, Petitioner sufficiently demonstrates that the Office materially erred in overlooking Morales-Sanfrutos’s and Singh’s teachings regarding their linker structures. Id. Further, to the extent the Lees’ teachings were considered during examination and reexamination, Lees’ disclosure of a homobifunctional sulfone linker was overlooked. Lees’ homobifunctional linker, which Patent Owner argues is substantially similar to Harris’ homobifunctional linker, which Petitioner chiefly relies upon in Grounds 2–5, was not the subject of a rejection during examination. Pet. Resp. Brief 1; Prelim. Resp. 25–26. We agree with Petitioner that only Lees’ heterobifunctional linker was applied in a rejection during examination. Pet. Resp. Brief 1; Ex. 1018, 42–43, 62. 4. Conclusion For the foregoing reasons, we decline to exercise discretion to deny institution under § 325(d).” slip op. at 27

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “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 (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 definition for purposes of determining whether to institute review because it is consistent with the disclosures of the asserted prior art references.” slip op. at 15

    Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
    Patents in suitUS 10,131,682
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