- 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 · GrahamPatents 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 · GrahamPatents 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 PhillipsPatents 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 PhillipsPatents in suitUS 11,014,090 - Bote, LLC v. Twitch LLCInstitutedPTAB · Nov 27, 2024 · IPR2024-00892 · APJ Cynthia L Murphy · IPR · Institution
The Board instituted review of claims 1–20 on all five asserted grounds, finding a reasonable likelihood that claim 20 would be unpatentable over Hoffmann, Swan, and Hoge.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“under 35 U.S.C. § 314(b), may not institute review on less than all claims challenged in the petition. SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1355–56 (2018). Moreover, in accordance with our rules, “[w]hen instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.” 37 C.F.R. § 42.108(a) (2020); see also PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition”). As discussed above, we determine that there is a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of at least one of the challenged claims (i.e., independent claim 20 on Ground One). Accordingly, we institute an inter partes review of all challenged claims (i.e., claims 1–20), based on Grounds One–Five asserted in the Petition.” slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“Petitioner asserts that it would have been “obvious to add Hoge’s tent covering (i.e., fabric floor 28)” to Hoffmann’s inflatable floor 6 and inflatable sides 4, 7 “to protect against punctures in such inflatable chambers.” Pet. 42. And Petitioner provides evidence that “modifying Hoffmann in such a way would be a routine implementation for a POSITA requiring merely adding an additional protective fabric floor (as informed by Hoge), rending predictable results.” Ex. 1004 ¶ 140. Patent Owner has not directed us to any contrary evidence. Thus, based on the evidence and arguments before us, there is a reasonable likelihood that Petitioner would prevail in showing that it would have been obvious to provide Hoffmann’s inflatable boat with a tent” slip op. at 10
§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,862,466 - Bote, LLC v. Twitch LLCInstitutedPTAB · Nov 27, 2024 · IPR2024-00889 · APJ Cynthia L Murphy · IPR · Institution
The Board instituted IPR of claims 1–15 on all six grounds, finding a reasonable likelihood that claim 10 is unpatentable over Hoffmann, Swan, and Hoge.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“under 35 U.S.C. § 314(b), may not institute review on less than all claims challenged in the petition. SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1355–56 (2018). Moreover, in accordance with our rules, “[w]hen instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.” 37 C.F.R. § 42.108(a) (2020); see also PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition”). As discussed above, we determine the record before us sufficiently shows a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of at least one of the challenged claims (i.e., independent claim 20 on Ground One). Accordingly, we institute an inter partes review of all challenged claims (i.e., claims 1–15), based on Grounds One–Six asserted in the Petition.” slip op. at 11
- Skill levelSkill level petitioner adoptedDecided for petitioner
“as having “a B.S. or higher degree in Mechanical Engineering (or an equivalent degree/experience) with sufficient experience in design, manufacture, use of inflatable watercraft and/or the materials and components that make up such products.” Pet. 18, see also Ex. 1004 ¶ 72. Petitioner contends that “[d]ue to the modest design and implementation complexities in the field,” POSITA will have “an average-level of problemsolving acumen and would seek solutions to design, material selection, and manufacturing issues for inflatable watercraft problems, but would look to other areas of recreational watercraft, surfboards, boats, other inflatable structures etc. to find similar solutions to similar problems confronted in the field.” Pet. 19–17; see also Ex. 1004 ¶ 72.10” slip op. at 6
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“Petitioner asserts that it would have been “obvious to add Hoge’s tent covering (fabric floor 28)” to Hoffmann’s inflatable floor 6 and inflatable sides 4, 7 “to protect against punctures in such inflatable chambers.” Pet. 64. And Petitioner provides evidence that “modifying Hoffmann in such a way would be a routine implementation for a POSITA requiring merely adding an additional protective fabric floor (as informed by Hoge), rending predictable results.” Ex. 1004 ¶ 137. Patent Owner has not directed us to any contrary evidence. Thus, based on the evidence and arguments before us, there is a reasonable likelihood that Petitioner would prevail in showing that it would have been obvious to provide Hoffmann’s inflatable boat with a tent covering extending between its lower chamber (floor 12) and its upper chamber (i.e., tubes 14, 16).” slip op. at 11
§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,479,458 - PTAB · Oct 3, 2024 · IPR2024-00648 · APJ Devon Zastrow Newman · IPR · Institution
The Board instituted IPR of claims 1–30 on all petitioned 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 1–30 of the ’462 patent is unpatentable.” slip op. at 2
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“Design, Eligibility). At this point in the proceeding, we interpret the “in response to” limitation of claim 1 to mean that pembrolizumab is administered to a patient after the patient has been determined to be microsatellite instability high or DNA mismatch repair deficient, regardless of whether pembrolizumab is also administered to other patients. The record is devoid of evidence that one of ordinary skill in the art would have understood treating a patient “in response to” the determination that the patient has a condition to exclude the same treatment of other patients, such as the treatment of control patients not having the condition.” slip op. at 22
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“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, 136. 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. Pet. 42–43 (citing Ex. 1003, ¶ 136). 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 actively treating patients with cancers that were known to be MSI-H with PD-1 inhibitors. Pet. 43 (citing Ex. 1016; Ex. 1017; Ex. 1003 ¶¶ 131–132). According to Petitioner, these other references would have “independently urged” those of ordinary skill in the art to treat MSI-H cancer with PD-1 inhibitors or other immunotherapy, such as pembrolizumab, and would have given them a reasonable expectation of success. Pet. 44–45. Petitioner cites, along with other references, Pernot, which states “[colorectal cancers] associated with MSI could lead to a more intense immune response, but also to specific immunoregulatory phenomena, making them good candidates for immunotherapy.” (Ex. 1006,3 3741; see Pet. 43.) Petitioner also cites Champiat, which states that” slip op. at 25
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner argues that one of ordinary skill in the art relevant to the ’462 patent would have been a medical doctor or a professional in a related field with at least five years of experience with treating cancer. Pet. 11 (citing Neugut Decl., Ex. 1003 ¶ 19). Petitioner argues further that the ordinarily skilled artisan would have had 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. Id. Patent Owner, having not entered a response, does not dispute Petitioner’s proposal about the POSA’s qualifications on this record.. For this Decision, we adopt and apply Petitioner’s proposal above, which is supported by Dr. Neugut’s testimony and does not appear to be inconsistent with the level of skill reflected in the asserted prior art.” slip op. at 8
§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,643,462 - 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 · GrahamPatents in suitUS 11,629,187 - PTAB · Sep 27, 2024 · IPR2024-00647 · APJ Sheridan K Snedden · IPR · Institution
The Board instituted IPR on claims 1–36 because the Petition showed a reasonable likelihood of prevailing on at least one challenged claim across the asserted grounds.
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 in the Petition, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving the unpatentability of at least one of claims 1–36 of the ’287 patent.” slip op. at 2
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“summarized above, we are persuaded by Petitioner that the MSI-H Study Record teaches treating colorectal cancer patients after they were determined to be microsatellite instability high or DNA mismatch repair deficient with pembrolizumab. See MSI-H Study Record, Ex, 1005, 4 (Arms and Interventions); see also id., 2 (Study Identification), 3 (Study Description), 4–5 (Outcome Measures), 5–6 (Eligibility); Ex. 1003, ¶¶ 58–62. We are also persuaded that Petitioner has sufficiently shown that there is a reasonable likelihood of a causal relationship in the MSI-H Study Record between treatment of colorectal cancer patients and the determination of their MSI status — all colorectal cancer patients determined to be microsatellite instability high or DNA mismatch repair deficient were treated with pembrolizumab. Whether or not other patients were treated or enrolled in the study does not detract from this teaching.3 Accordingly, we are persuaded by Petitioner that, on this record, the MSI-H Study Record discloses each element of claim 1. In view of the above, we determine that Petitioner has sufficiently shown a reasonable likelihood of establishing that the MSI-H Study Record anticipates claim 1. Patent Owner at this stage does not offer any arguments addressing Petitioner’s substantive showing.” slip op. at 16
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“not disclose the limitation of “in response to determining that the colorectal cancer is microsatellite instability high or DNA mismatch repair deficient, treating a human patient having colorectal cancer that is microsatellite instability high or DNA mismatch repair deficient with a therapeutically effective amount of pembrolizumab,” the record before us supports this limitation being rendered obvious by Pernot and the MSI-H Study Record. Specifically, because Pernot teaches that colorectal cancer patients are good candidates for immunotherapy, the evidence of the current record shows that one of ordinary skill in the art would have had a reason to use to PD-1 inhibitors to treat colorectal cancers. Ex. 1006, 3741; Ex. 1003 ¶ 136. Additionally, the focus in the MSI-H Study Record on a clinical study treating colorectal cancer patients who had been determined to be MSI-H with pembrolizumab indicates that it would have been obvious to test for this condition before treatment. The additional references discussed by Petitioner contribute further to a reasonable likelihood that Petitioner will prevail. For example, Libson reports the successful treatment of a colorectal cancer patient having MSI-H status with a PD-1 inhibitor (Ex. 1057, 463-64) and Champiat discusses evaluating the clinical activity of PD-1 agents in DNA mismatch repair, such as MSI+, colorectal cancer (Ex. 1032, e27817-5). Pet. 44 (citing Ex. 1003 ¶ 49). Thus, based on the current record, we determine that Petitioner presents a reasonable likelihood that the method of claim 1 would have been considered obvious by one of ordinary skill in the art. Accordingly, in view of the above, we are persuaded that there is a reasonable likelihood that Petitioner will prevail with respect to at least one claim challenged under Ground 2 in the Petition.” slip op. at 21
- Skill levelSkill level petitioner adoptedOther
“Petitioner proposes that a person of ordinary skill in the art (“POSA” or “POSITA”) at the time of the invention would be a medical doctor or a professional in a related field with at least five years of experience with treating cancer. . . . The POSA would also have experience in or access to a person with knowledge of clinical studies for therapeutics and how they work and a pathologist with comparable experience. . . . The inherent anticipation and obviousness grounds discussed herein would not change due to a modestly lesser or greater level of experience. Pet. 11–12 (citing Ex. 1003 ¶ 19). For this Decision, we adopt and apply Petitioner’s proposal above, which does not appear to be inconsistent with the level of skill reflected in the asserted prior art.” slip op. at 7
§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,649,287 - 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 · GrahamPatents in suitUS 11,634,491
Holdings, summaries, rulings, issues, outcomes, winners and claim constructions shown for a decision were generated by a large language model reading the opinion. They are a guide to the decision, not the decision. Confirm every one against the court's own text before relying on it. Outcomes read from the patent owner’s side. Party names are extracted from the decision and are missing on about 900 short Director denials and scans, which carry the trial number instead.