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  • PTAB · Jan 26, 2026 · IPR2024-01179 · APJ Carl M Defranco · IPR · Final written decision

    Claims 1–25 are unpatentable under § 103 over the asserted combinations of Waldner, Dynatek, and additional references; the Board cancelled all challenged claims.

    RulingsFinal written decision
    • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

      “Also, to the extent Masaba relies on extrinsic expert testimony, we note that Masaba’s expert cites absolutely no support for his understanding of the claims, much less explains why we should adopt his understanding over the plain and ordinary meaning of “conveying aggregate” and “moving aggregate.” See Ex. 2004 ¶ 34. Absent supporting citations, such extrinsic testimony is entitled to little, if any, weight. As such, we reject the notion that Waldner’s discharge chute member 242 is not a conveyor “for conveying aggregate” or “for moving aggregate,” as required by claim elements 1[h] and 1[i].” slip op. at 21

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “We disagree that Dr. Durham does not possess the necessary level of skill in the art to qualify as an expert in this case. Looking at the specification of the ’689 patent and the prior art of record, we think Masaba sets the bar too high. We acknowledge that one of ordinary skill in the art should have some education and/or experience in the mechanical art of conveying aggregate materials, but we do not think opining on the ’689 patent and asserted prior art necessarily requires that person to have the amount of education and experience that Masaba advocates. The ’689 patent relates generally to an “aggregate transferring system for receiving aggregate from a vehicle and elevating the aggregate to a higher vertical level for deposit into, for example, a silo.” Ex. 1001, 1:15– 18. And, as described in the ’689 patent and discussed later, the transferring system is an assembly of known types of conveyors, such as a belly-dump truck conveyor, a bucket elevator, and an articulated belt conveyor, for transferring the aggregate horizontally and vertically from a belly-dump truck to the discharge point, such as a silo. Without doubt, Dr. Durham has enough education and experience to reliably opine on the combination of known parts.” slip op. at 8

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningNo construction needed

      “We reject this argument for several reasons. First, nowhere does the plain language of the claims specify how the aggregate is conveyed or moved from the conveyor extension assembly’s inlet to its outlet, be it passively by means of gravity or actively by means of a conveyor belt. Instead, the claims simply use those verbs according to their plain and ordinary meaning, which is “to transfer or deliver” or “to cause to go or pass” from one place to another. See Ex. 3001, 253 (defining “convey”), 760 (defining “move”).10 Second, the specification of the ’689 patent similarly uses these terms in a plain and ordinary sense, without ever attributing to them some sort of special meaning. See, e.g., Ex. 1001, 4:9–12 (“The apparatus 10 is suitable for performing the transfer of aggregate from 10 We reference the original pagination of the dictionary in which these definitions appear. one location to another, such as, for example, from a vehicle carrying the aggregate to a silo 1 for storing the aggregate.”). The ’689 patent specification also makes clear that active conveyance of the aggregate is an option and not a requirement of the claimed invention, stating that the conveyor extension assembly “may further include a conveyor belt 150.” Ex. 1001, 10:60–66 (emphasis added). Limiting claim elements 1[h] and 1[i] to a device “for actively conveying” or “for actively moving aggregate” would improperly import limitations from the specification into the claims. Thus, based on the intrinsic evidence, we determine that claim elements 1h and 1k are properly construed to encompass passive and/or active movement of the aggregate via the conveyor extension assembly.” slip op. at 20

    • Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)Not reached

      “Owner asserts” that two claim terms—“unloader structure” and “trailer structure”—should be construed as means-plus-function limitations under 35 U.S.C. § 112(f), Solaris submits an express construction detailing the corresponding structure in the specification for performing the recited function of the claimed unloader and trailer structures. See id. at 24–25. Only in disputing Solaris’s Ground 3 does Masaba advocate that the claim term “trailer structure” should be construed under § 112(f), and then only in conjunction with dependent claims 3 and 21. See PO Resp. 58. As such, we address Masaba’s proposed construction in our analysis of Ground 3. We now turn to Solaris’s grounds of unpatentability.” slip op. at 12

    Patent outcomesUS 11,780,689 unpatentable
    Claim construction§ 103 obviousnesscites KSR
    Patents in suitUS 11,780,689
  • PTAB · Jan 15, 2026 · IPR2024-01137 · APJ Carl M Defranco · IPR · Final written decision

    Claims 1–7 and 9–23 were not shown unpatentable under § 103 because the asserted combinations failed to teach the claimed mouthpiece movement or bite-actuated compression.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Trove contends that a person of ordinary skill in the art “would have had an undergraduate degree in mechanical engineering or equivalent coursework, and a year or more of experience in designing, prototyping, and/or manufacturing fluid containers or similar products” and that “[m]ore work experience may substitute for a lower level of education, and vice versa.” Pet. 18 (citing Ex. 1003 ¶ 26). While CamelBak offers a “slightly different” level of skill in the art, it nonetheless “discerns no material difference between the definitions provided by the parties for purposes of the 2 JP 2002-211613, published July 31, 2002 (Ex. 1004, “Nakajima”). 3 US 6,070,767, issued June 6, 2000 (Ex. 1005, “Gardner”). 4 WO 2004/063042, published July 29, 2004 (Ex. 1006, “Ribarits”). 5 US 4,485,963, issued Dec. 4, 1984 (Ex. 1007, “Panicci”). 6 US 6,523,711 B1, issued Feb. 25, 2003 (Ex. 1010, “Hughes”). Board’s decision on the patentability of the ’255 patent.” PO Resp. 14–15. That being the case, we adopt Trove’s proposed definition of the level of skill in the art, as it is reasonable and consistent with what is reflected in the asserted prior art and the specification of the ’255 patent. B. Claim Construction” slip op. at 7

    • Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalTerm construed patent owner constructionDecided for patent owner

      “not move in a circular path that maintains a constant radius about the axis of rotation defined by McDonough’s axle 30, but instead engages in up-and-down translational motion (red arrows) relative to axle 30. Thus, we understand CamelBak’s arguments during reexamination to have distinguished the purely rotational (i.e., circular) motion of the claimed mouthpiece from a mouthpiece that moves with a translational component relative to the pivotal axis. In sum, this reexamination history shows that, by distinguishing over the translational motion of McDonough’s mouthpiece, CamelBak limited the claimed mouthpiece to one that (1) maintains a circular path of constant radius about the pivotal mount’s axis of rotation, and (2) does not include a path that has a translational component relative to the pivotal axis. See Fenner Investments, Ltd. v. Cellco Partnership, 778 F.3d 1320, 1323 & 1325 (Fed. Cir. 2015) (“Any explanation, elaboration, or qualification presented by the inventor during patent examination is relevant, for the role of claim construction is to capture the scope of the actual invention that is disclosed, described, and patented.”) (internal quotation marks omitted); CVI/Beta Ventures, Inc. v. Tura LP, 112 F.3d 1146, 1158 (Fed. Cir. 1997) (“[T]hrough statements made during prosecution or reexamination an applicant for a patent or a patent owner, as the case may be, may commit to a particular meaning for a patent term, which meaning is then binding in litigation.”) (emphasis added); see also Univ. of Massachusetts v. L’Oreal S.A., 36 F.4th 1374, 1379 (Fed. Cir. 2022) (“The prosecution history, in particular, may be critical in interpreting disputed claim terms, and even where prosecution history statements do not rise to the level of unmistakable disavowal, they do inform the claim construction.”) (internal quotations omitted).” slip op. at 17

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

      “Those detailed descriptions demonstrate that “adapted to,” as recited in claims 1 and 20, means that the resilient mouthpiece is specifically designed and configured to dispense fluid as a result of a user biting the mouthpiece, rather than merely being “capable of” being compressed. See Giannelli, 739 F.3d at 1379–80. Indeed, as disclosed, a distinct benefit of the resilient mouthpiece being bite-actuated “is that a user may position the drink bottle (and mouthpiece) to a desired drinking orientation, and even a partially or completely inverted orientation, without drink fluid being dispensed from the mouthpiece” until the user bites upon the mouthpiece to commence fluid flow through self-sealing valve to the user. Id. at 10:9–19. Thus, the intrinsic evidence, i.e., the specification and figures of the ’255 patent, confirm that the phrase “adapted to” means “designed or configured to” and is not satisfied by mere hypothetical capability. That is, as claimed, the resilient mouthpiece is designed or configured to compress based on actual forces applied by a user’s teeth, as opposed to merely being capable of compression based on the inherent nature of the mouthpiece’s material. C. Obviousness” slip op. at 24

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

      “Although we agree with Trove that Nakajima’s mouthpiece engages in up-and-down movement relative to the pivot axis identified in Trove’s annotated figures, we disagree that Nakajima’s mouthpiece is “pivotal about an axis defined by the pair of lateral projections as [they] rotate within the pair of sockets,” as required by claim 1. As discussed above, the proper construction of this claim limitation requires that the mouthpiece moves with rotational motion in a circular path of constant radius about the pivotal axis defined by the pair of lateral projections. See supra § II.B.1. Nakajima, on the other hand, discloses that its mouthpiece moves with translational motion, i.e., up-and-down movement, relative to the pivotal axis defined by lateral projections 19 of Nakajima’s lid 4—“[T]he mouthpiece moves up and down in conjunction with the opening and closing of the lid.” Ex. 1004 ¶ 3 (emphasis added); see also id., Abstract (“[T]he mouthpiece 2 moves up and down in conjunction with the opening and closing of the lid 4.”). Indeed, although Trove relies exclusively on Nakajima’s disclosure of up-and-down movement for the mouthpiece, Trove never explains how such up-and-down movement equates to rotational motion required by the disputed limitation of claim 1. Nor can it.” slip op. at 28

    Patent outcomesUS 10,676,255 not shown unpatentable
    Claim construction§ 103 obviousness
    Patents in suitUS 10,676,255
  • 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 · Nov 17, 2025 · IPR2024-00648 · APJ Devon Zastrow Newman · IPR · Final written decision

    Claims 1–30 are unpatentable: claims 1–2, 4–7, 9–12, 14–17, and 19–30 are anticipated by the MSI-H Study Record; claims 3, 8, 13, and 18 are obvious over the cited combinations.

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

      “We agree with Patent Owner that the phrase “in response to” in claim 1 requires a causal relationship wherein the patient must be tested for MSI-H and, if he or she is determined to be MSI-H or dMMR, then the patient is treated with 10 mg/kg of pembrolizumab every 14 days. In claim 1, a biological sample from the patient must be tested to determine if the cancer is MSI-H and, if so, the patient is treated with a therapeutically effective amount of pembrolizumab. For this reason, if the prior art teaches the limitations of 1) testing a biological sample obtained from a patient having cancer to determine that the patient’s cancer is microsatellite instability high or mismatch repair deficient, and 2) treating the patient with a therapeutically effective amount of pembrolizumab if the patient’s cancer is determined to be microsatellite instability high or DNA mismatch repair deficient, the art anticipates claim 1. We are not persuaded that claim 1 requires or excludes anything else because nothing else is recited in the claim.” slip op. at 10

    • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityReference is prior artDecided for petitioner

      “Patent Owner does not direct us to evidence that it attempted to file any patent application before the publication date of the MSI-H clinical study and was denied an earlier filing date. Contrary to Patent Owner’s argument that it could not file a patent application without results from the MSI-H clinical study, we note that the inventors filed a provisional patent application on November 13, 2014, which, although also filed more than a year after the publication of the MSI-H clinical study, disclosed no clinical results or data. Ex. 1001, cover; Ex. 1030, 1. After considering the parties’ arguments, we are not persuaded by Patent Owner’s assertion that the inventors could not have filed an earlier application to at least attempt to secure a priority date before the MSI-H clinical study was publicly available. an earlier filing date. Instead, we are persuaded by Petitioner’s argument that because the MSI-H clinical study was published before the inventors filed an application to protect their patent rights the MSI-H clinical study is prior art for the information it discloses. Accordingly, we proceed to analyze Petitioner’s contentions in Ground 1.” slip op. at 24

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

      “the genus disclosed in the MSI Study Record and does not argue or provide evidence to show that one of ordinary skill in the art could have envisaged each species within that genus. PO Resp. 11–14. We are not persuaded that either the size of the genus in the MSI Study Record or whether one of ordinary skill in the art would have been able to envisage every species within it is dispositive of whether the MSI Study Record anticipates claim 1, where one of ordinary skill in the art would have known that specific cancers recited in claim 1 would be included in the MSI Study Record. As Petitioner argues, claim 1 requires that “a patient…selected from the group consisting of [the listed cancers]” be tested and treated. Pet. Reply 10 (emphasis original). Claim 1 does not require that the patient have each and every one of the sixteen listed cancers to anticipate the claim. Rather, claim 1 requires testing a sample from “a patient” with one of the recited types of cancer and treating the patient. See Brown v. 3M, 265 F.3d 1349, 1351 (Fed. Cir. 2001) (“When a claim covers several structures or compositions, either generically or as alternatives, the claim is deemed anticipated if any of the structures or compositions within the scope of the claim is known in the prior art.”).” slip op. at 31

    • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

      “In contrast, the testimony of Patent Owner’s witness, Dr. Goldberg, supports Petitioner’s argument of the knowledge in the art at the time, wherein Dr. Goldberg testifies that “[w]hile many clinical oncologists were aware that patients with Lynch Syndrome had a defect in DNA mismatch repair, they associated MSI testing with young onset colorectal and endometrial cancer and patients with a family history of colorectal and/or endometrial cancer.” Ex. 2090 ¶ 79. Similarly, during his deposition, Dr. Goldberg also agreed that endometrial, gastric, and small-bowel cancers would come to mind when he saw a reference to MSI-high non-colorectal cancer. See Ex. 1243, 115:5–116:22 (Q. And so does endometrial cancer come to mind when you see reference to MSI-high non-colorectal cancers? . . . A. Yes. Q. As . . . a person of skill in the field, when you see reference to MSI-high non-colorectal cancers, does gastric cancer come to mind? . . . A. comes to mind. So the answer is yes. Q. As a person of skill in the field, when you see reference to MSI-high non-colorectal cancers, does small bowel cancer come to mind? . . . A. Yes.”). Patent Owner does not direct us to other evidence contradicting Petitioner’s argument that MSI-H was known to occur in endometrial, small bowel, and gastric cancer. Pet. 18.” slip op. at 30

    Patent outcomesUS 11,643,462 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,643,462
  • PTAB · Nov 10, 2025 · IPR2025-00878 · APJ Carl M Defranco · IPR · Institution

    The Board instituted review of claims 1–3 and 11 after finding a reasonable likelihood that claim 1 is anticipated by Cleveland or obvious over Nakagawa.

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

      “contentions, the cited portions of Cleveland, and the testimony of Clearwater’s expert), we find, preliminarily, that Cleveland discloses each claim element in the manner recited by claim 1. Thus, on the current record, Clearwater demonstrates a reasonable likelihood that challenged claim 1 is unpatentable as anticipated by Cleveland.” slip op. at 6

    • Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference is prior artDecided for petitioner

      “5 Clearwater argues that Cleveland qualifies as prior art under 35 U.S.C. § 102(e)(1) “based on both its provisional and non-provisional filing dates.” Pet. 17. In support, Clearwater asserts that Cleveland’s provisional (Ex. 1006) is “virtually identical” to Cleveland itself (id. at 18) and submits claim charts to demonstrate that the Cleveland provisional provides written support for: (1) at least claim 1 of Cleveland (id. at 18–21); and (2) the subject matter relied upon in Cleveland (id. at 21–40 (citing Ex. 1006 throughout)). Based on our review of the Cleveland provisional, as well as Clearwater’s claim charts, we are persuaded that the current record demonstrates that Cleveland is prior art to the challenged patent. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1381 (Fed. Cir. 2015).” slip op. at 4

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

      “satisfies each claim element as identified above in Section I.D, i.e., elements [1.pre]–[1.6]. See id. at 22–40. Clearwater also submits annotated Figure 3 of Cleveland, reproduced below, to further illustrate the specific laminate structure of Cleveland’s coffee cup. See id. at 39.” slip op. at 5

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

      “protective layers have “a coat weight of from 5 to 30 lbs/3000 ft2,” Clearwater submits the declaration of its expert, who explains that, because Nakagawa identifies the specific polymers and the thickness of the coat used for the plastic layers and one skilled in the art “would recognize that the disclosed polymers have a given density,” then “[w]ith these known parameters, the coat weight is easily calculated to be 23.04 lbs./ 3000 ft2 — falling squarely within the claimed range.” Pet. 53–54 (citing Ex. 1003 ¶¶ 132–133; Ex. 1008 ¶ 24; Ex. 1024, at 4). At this stage, we find that testimony credible and supported by the evidence presently of record. After reviewing the preliminary record (including Clearwater’s contentions, the cited portions of Nakagawa, and the testimony of Clearwater’s expert), we find, preliminarily, that Nakagawa discloses or otherwise suggests each claim element in the manner recited by claim 1. Thus, on the current record, Clearwater demonstrates a reasonable likelihood that challenged claim 1 is unpatentable as obvious over Nakagawa. We need not decide Clearwater’s challenge of the dependent claims based on Nakagawa alone nor its challenge of claims 1–3 based on Nakagawa and Tanner. Our analysis of these challenges, in our view, is best left for trial after full development of the record.” slip op. at 8

    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips
    Patents in suitUS 8,637,126
  • PTAB · Nov 6, 2025 · IPR2024-00623 · APJ Devon Zastrow Newman · IPR · Final written decision

    Claims 1–7 are unpatentable: claims 1–3 and 5–7 are anticipated by the MSI-H Study Record, and claim 4 is obvious over the MSI-H Study Record and other cited references.

    RulingsFinal written decision
    • Expert testimonyPetitioner expert creditedDecided for petitioner

      “On balance, we find Petitioner’s evidence more persuasive of what one of ordinary skill in the art would have understood from the MSI-H Study Record. We find Dr. Neugut’s and Dr. Oberstein’s testimony, and Dr. Lonberg’s lack of clear testimony to the contrary, persuasive as to this issue. In addition, we are not persuaded by the case law cited by Patent Owner regarding inherent anticipation. See PO Resp. 6–7. Rather, we agree with Petitioner that the correct inquiry is whether the skilled artisan would have understood that all limitations are disclosed in the prior art. See Pet. 34–35; Pet. Reply 12–13. In light of the cited testimony, we are persuaded that Petitioner has met its burden of proving that a skilled artisan would reasonably have understood or inferred that the limitation for a patient having received a prior cancer therapy drug to treat the tumor was disclosed in the MSI-Study Record. Petitioner demonstrates what one of ordinary skill in the art would have understood from the MSI-H Study Record, not what it inherently discloses. Contra PO Resp. 6–9.” slip op. at 22

    • Skill levelSkill level board ownDecided for petitioner

      “In light of the extent of the relevant field, we determine that the level of skill in the art relevant to the claims of the ’974 patent is not limited to knowledge of and experience with conducting research relating to oncology or developing and conducting clinical trials, but includes knowledge of and experience with treating cancer patients with immunotherapy compounds, identifying the conditions these patients may have, and understanding the literature regarding clinical trials for such colorectal cancers and the associated conditions and immunotherapy.” slip op. at 9

    • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
    Patent outcomesUS 11,325,974 unpatentable
    § 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,325,974
  • PTAB · Nov 4, 2025 · IPR2024-00624 · APJ Sheridan K Snedden · IPR · Final written decision

    Claims 1–4, 6–10, and 12–15 are unpatentable, principally because the MSI-H Study Record anticipates them.

    RulingsFinal written decision
    • Skill levelSkill level board ownDecided for petitioner

      “Pet. 12 (citing Ex. 1003 ¶ 19). To Patent Owner, the ordinarily skilled artisan would have had a medical or graduate-level degree, or equivalent work experience, in the fields of immunology, genetics, or a related field and would have experience (i) conducting immunology research relating to oncology, (ii) conducting genetics research relating to oncology, or (iii) developing and conducting clinical trials on novel cancer therapies in those fields. PO Resp. 6 (citing Ex. 2072 ¶¶ 31–32, 86–94). Thus, Petitioner and Patent Owner characterize one of ordinary skill in the art differently. Petitioner emphasizes medical and treatment aspects in its characterization of an ordinarily skilled artisan, whereas Patent Owner emphasizes research aspects.” slip op. at 8

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

      “The parties do not assert constructions of any terms recited in the challenged claims other than that their ordinary and customary meanings should apply. Pet. 11–12; PO Resp. 6. We determine that no express construction of any claim term is necessary to resolve the dispute between the parties. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We construe” slip op. at 7

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

      “record, we are persuaded that the results recited in claim 1 would follow from the steps taught in the MSR, for the reasons and based on the evidence Petitioner cites above. For these same reasons, we are unpersuaded by Patent Owner’s argument that it was unknown whether the amount of pembrolizumab recited in claim 1 would be effective in producing an improved outcome compared to a reference patient without a tumor that was not MSI-H or dMMR, and Patent Owner does not dispute that the amount of pembrolizumab disclosed in the MSR (10 mg/kg every 14 days; see Ex. 1005, 4) is the same as the amount provided in the ’975 patent as being effective (10 mg/kg every 14 days; Ex. 1001, 8:48–52, 13:50–52). Regardless of the inventors’ intent in publishing the MSR as a Stage II clinical trial on the www.clinicaltrials.gov website, as discussed above, we determine that the MSR teaches selecting a patient with a metastatic MSI-H or dMMR tumor and administering an amount of pembrolizumab that would be effective. See, e.g., Ex. 1005, 4 (Arms and Interventions). The result of drug treatment inherently follows its administration. The MSR does not merely suggest that pembrolizumab may be useful in some unidentified subset of patients or suggest that some unidentified drug may be useful for MSI-H cancer patients. Instead, the MSR discloses selecting a patient with a condition recited in claim 1 and treating with the drug at the amount recited in claim 1. Contra Metabolite Labs. Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1367 (Fed. Cir. 2004) (holding that the prior art did not inherently anticipate where it failed to mention specific vitamin deficiencies, instead merely inviting further experimentation to find associations with metabolic perturbations). requirement, efficacy is inherent in carrying out the claim steps,” referring to a claimed method of treating or preventing stroke, which was held to be anticipated by the publication of a proposed study. 677 F.3d at 1381. Patent Owner attempts to distinguish the size and apparent surety of the study in Montgomery from the MSR. PO Resp. 15. But because we find that the MSR teaches performing the steps recited in claim 1 for the purpose of determining and treating MSI-H cancer, we are persuaded that the MSR inherently discloses the results of selection of patients and administration of the drug treatment recited in those steps. See Bristol-Myers, 246 F.3d at 1376. Whether or not the MSR could have provided results or was sufficient for full regulatory approval does not change that the MSR teaches Patent Owner’s claimed steps. We have no reason to doubt that the disclosure in the MSR of the steps recited in claim 1 produces the efficacy element required in claim 1, whether or not this efficacy was disclosed in the MSR or was known when it was published. See Mehl/Biophile, 192 F.3d at 1366 (“Where, as here, the result is a necessary consequence of what was deliberately intended, it is of no import that the article’s authors did not appreciate the results.”).” slip op. at 21

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

      “use that does not qualify as prior art. PO Resp. 18–25. Patent Owner argues that an inventor can be granted latitude to experiment in the public eye until her invention is ready for patenting. Id. at 18 (citing Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 64 (1998). According to Patent Owner, the experimental use negation applies to the MSR under a 13-factor analysis provided in Allen Engineering Corp. v. Bartell Industries, Inc., 299 F.3d 1336, 1353 (Fed. Cir. 2002). PO Resp. 19–25. For example, Patent Owner argues that to establish that treatment of MSI-H cancers was effective, the inventors had to test treatment in humans, there being no animal models, and had to publish the MSR on the government website under federal law. Id. at 20–22. Patent Owner argues further that the inventors had control over the MSI-H clinical study and that the field of cancer treatment was highly unpredictable, among other facts. Id. at 21. Patent Owner argues that “[a]t the time of the MSR’s posting, the claimed invention was not, nor could it have been, ready for patenting. The clinical study that ultimately collected the data reported in the patent specification and supporting the patent claims had not and could not have commenced before the MSR was posted.” Id. at 23. sometimes said that an inventor acquires an undue advantage over the public by delaying to take out a patent, inasmuch as he thereby preserves the monopoly to himself for a longer period than is allowed by the policy of the law,” but held that “when the delay is occasioned by a bona fide effort to bring his invention to perfection, or to ascertain whether it will answer the purpose intended,” the experiment use exception can preserve the inventor’s rights. City of Elizabeth v. Am. Nicholson Pavement Co., 97 U.S. 126, 137 (1877). Because we are not persuaded that Patent Owner could not have filed an earlier application, we are not persuaded that the experimental use doctrine is properly applied in this case. Given that clinical trial protocols published on the ClinicalTrials.gov website have been successfully asserted as prior art in other cases, we are not persuaded by Patent Owner’s arguments that the MSR is not available as prior art against the challenged claims. See, e.g., Salix Pharms., Ltd. v. Norwich Pharms. Inc., 98 F.4th 1056, 1061 (Fed. Cir.), cert. denied, 145 S. Ct. 567 (2024), and cert. denied, 145 S. Ct. 983 (2024).” slip op. at 24

    Patent outcomesUS 11,325,975 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,325,975
  • PTAB · Oct 28, 2025 · IPR2024-00622 · APJ Sheridan K Snedden · IPR · Final written decision

    Claims 1–28 are unpatentable: claims 1, 6–11, 13–20, 22–24, and 26–28 as anticipated by the MSI-H Study Record; claims 2–5, 12, 21, and 25 as obvious.

    RulingsFinal written decision
    • BurdenUnpatentable

      “(“the claimed process here is not directed to a new use; it is the same use, and it consists of the same steps as described by [the prior art]. Newly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.”). After analysis of the full record, we are persuaded that the results recited in claim 1 would follow from the steps taught in the MSR, for the reasons and based on the evidence Petitioner cites above. For these same reasons, we are unpersuaded by Patent Owner’s argument that it was unknown whether the amount of pembrolizumab recited in claim 1 would be effective in producing an improved outcome compared to a reference patient without a tumor that was not MSI-H or dMMR, and Patent Owner does not dispute that the amount of pembrolizumab disclosed in the MSR (10 mg/kg every 14 days; see Ex. 1005, 4) is the same as the amount provided in the ’356 patent as being effective (10 mg/kg every 14 days; Ex. 1001, 8:48–52, 13:50–52). Regardless of the inventors’ intent in publishing the MSR as a Stage II clinical trial on the www.clinicaltrials.gov website, as discussed above, we determine that the MSR teaches selecting a patient with a metastatic MSI-H or dMMR tumor and administering an amount of pembrolizumab that would be effective. See, e.g., Ex. 1005, 4 (Arms and Interventions). The result of drug treatment inherently follows its administration. The MSR does not merely suggest that pembrolizumab may be useful in some unidentified subset of patients or suggest that some unidentified drug may be useful for MSI-H cancer patients. Instead, the MSR discloses selecting a patient with a condition recited in claim 1 and treating with the drug at the amount recited in claim 1. Contra Metabolite Labs. Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1367 (Fed. Cir. 2004) (holding that the prior art did not” slip op. at 22

    • Skill levelSkill level board ownDecided for petitioner

      “Petitioner and Patent Owner characterize one of ordinary skill in the art differently. To Petitioner, the ordinarily skilled artisan would have been a medical doctor, or a professional in a related field, with experience treating cancer or access to those with experience in clinical studies of therapeutics and to a pathologist with this experience. Pet. 11 (citing Ex. 1003 ¶ 19). To Patent Owner, the ordinarily skilled artisan would have had a medical or graduate-level degree, or equivalent work experience, in the fields of immunology, genetics, or a related field and would have experience (i) conducting immunology research relating to oncology, (ii) conducting genetics research relating to oncology, or (iii) developing and conducting clinical trials on novel cancer therapies in those fields. PO Resp. 5–6 (citing Ex. 2072 ¶¶ 31–32, 86–94). Petitioner emphasizes medical and treatment aspects in its characterization of an ordinarily skilled artisan, whereas Patent Owner emphasizes research aspects. The ’356 patent claims a method of treating a human patient with cancer having certain characteristics using pembrolizumab and the main prior art reference cited by Petitioner, MSR, discloses testing Ex. 1005. Accordingly, the relevant field of Patent Owner’s claims is treating human patients for cancer, as well as testing existing compounds for use in treatment modalities. In light of the extent of the relevant field, we determine that the level of skill in the art relevant to the claims of the ’356 patent is not limited to knowledge of and experience with conducting research relating to oncology or developing and conducting clinical trials, but includes knowledge of and experience with treating cancer patients with immunotherapy compounds, identifying the conditions these patients may have, and understanding the literature regarding clinical trials for such colorectal cancers and the associated conditions and immunotherapy.” slip op. at 9

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

      “The parties do not assert constructions of any terms recited in the challenged claims other than that their ordinary and customary meanings should apply. Pet. 10–11; PO Resp. 6. We determine that no express construction of any claim term is necessary to resolve the dispute between the parties. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We construe claims “in accordance with the ordinary and customary meaning of such history pertaining to the patent.” 37 C.F.R. § 42.100(b) (2020).” slip op. at 8

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency foundUnpatentable

      “(“the claimed process here is not directed to a new use; it is the same use, and it consists of the same steps as described by [the prior art]. Newly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.”). After analysis of the full record, we are persuaded that the results recited in claim 1 would follow from the steps taught in the MSR, for the reasons and based on the evidence Petitioner cites above. For these same reasons, we are unpersuaded by Patent Owner’s argument that it was unknown whether the amount of pembrolizumab recited in claim 1 would be effective in producing an improved outcome compared to a reference patient without a tumor that was not MSI-H or dMMR, and Patent Owner does not dispute that the amount of pembrolizumab disclosed in the MSR (10 mg/kg every 14 days; see Ex. 1005, 4) is the same as the amount provided in the ’356 patent as being effective (10 mg/kg every 14 days; Ex. 1001, 8:48–52, 13:50–52). Regardless of the inventors’ intent in publishing the MSR as a Stage II clinical trial on the www.clinicaltrials.gov website, as discussed above, we determine that the MSR teaches selecting a patient with a metastatic MSI-H or dMMR tumor and administering an amount of pembrolizumab that would be effective. See, e.g., Ex. 1005, 4 (Arms and Interventions). The result of drug treatment inherently follows its administration. The MSR does not merely suggest that pembrolizumab may be useful in some unidentified subset of patients or suggest that some unidentified drug may be useful for MSI-H cancer patients. Instead, the MSR discloses selecting a patient with a condition recited in claim 1 and treating with the drug at the amount recited in claim 1. Contra Metabolite Labs. Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1367 (Fed. Cir. 2004) (holding that the prior art did not” slip op. at 22

    Patent outcomesUS 10,934,356 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 10,934,356
  • PTAB · Oct 28, 2025 · IPR2024-00858 · APJ Carl M Defranco · IPR · Final written decision

    Claims 5–7 and 16–19 were not shown unpatentable under § 102 or § 103 because the cited references failed to disclose the claimed closure retention mechanism.

    RulingsFinal written decision
    • Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)§112(f) appliesPrior construction adoptedDecided for petitioner

      “1. “closure retention mechanism” Trove proposes that “closure retention mechanism” should be construed as a means-plus-function term under 35 U.S.C. § 112(f). See Pet. 18–19; Pet. Reply 1. CamelBak agrees. See PO Resp. 8. Indeed, subsequent to our institution decision, the district court in the parallel action held that the “closure retention mechanism” is a means-plus-function term governed by 35 U.S.C. § 112(f). See Ex. 2010, at 5–6. We see no reason to depart from that holding and adopt the district court’s reasoning in that regard as our own. See id. at 6–8.” slip op. at 7

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

      “We agree with CamelBak that the plain language of the claim imposes a temporal condition on when the closure is received by the closure retention mechanism, namely, only after it is removed from the drink spout. In other words, the closure cannot be in engagement with, i.e., “received by,” the closure retention mechanism while it remains on the drink spout. This interpretation is consistent with the specification, which repeatedly states that spaced-apart tabs 56 “engage” the closure when it is removed from the spout and moved to the stowed position. Ex. 1001, 8:58–60 (“tabs 56 . . . are configured to selectively engage and retain, or otherwise grip, the closure in the stowed position”); 9:32–39 (“when the closure is positioned between and/or otherwise in engagement with the tabs, the tabs engage the closure across the maximum width, such as with the tabs resiliently deflecting, bending, or compressing to accommodate the greater width of the closure”); 11:36–39 (“the closure retention mechanism 54 may be configured to engage . . . the closure to operatively retain the closure in its stowed configuration.”); 13:26–31 (“When the closure is operatively positioned within the closed perimeter of the handle into its stowed position . . . such closure is compressed slightly.”) (emphases added). Moreover, the specification describes this engagement as occurring by means of a “friction-fit” or “snap-fit” arrangement (id. at 8:50–52, 14:33– 36), which confirms that the closure is not permanently engaged with the tabs, but rather moved into engagement with the tabs, i.e., “received by the closure retention mechanism” per the plain language of the claim. Thus, the intrinsic evidence—the claim language and the specification—supports a construction that imposes a temporal condition on the recited function of the claimed “closure retention mechanism” such that it receives the closure only after the closure has been removed from the drink spout, meaning the closure is not engaged with the closure retention mechanism before it is selectively removed from the drink spout.” slip op. at 13

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

      “3. “retain the closure in a stowed position” CamelBak contends that this limitation should be construed to mean “to hold or keep the closure in a position removed from the drink spout.” PO Resp. 13–14; PO Sur-Reply 4. Although Trove contends that CamelBak’s construction “impermissibly rewrites” the claim language, Trove nonetheless “does not disagree that it encompasses ‘hold or keep the Indeed, the claim language itself already contemplates just such a construction by expressly reciting that the closure retention mechanism “selectively retain[s] the closure in a stowed position relative to the handle when the closure is selectively removed from the drink spout.” Ex. 1001, 18:63–66 (emphasis added). As such, we determine that further construction of this limitation is not necessary to resolve the present dispute.” slip op. at 14

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Trove proposes that one of ordinary skill in the art would have had— an undergraduate degree in mechanical engineering or equivalent coursework, and a year or more of experience in designing, prototyping, and/or manufacturing fluid containers or similar products . . . [and that] [m]ore work experience may substitute for a lower level of education, and vice versa. Pet. 17–18 (citing Ex. 1003 ¶¶ 25–30). 2 US 9,272,822 B2, issued Mar. 1, 2016 (Ex. 1004, “Samartgis”). 3 EP 2 177 447 A1, published Apr. 21, 2010 (Ex. 1011, “Gorskey”). 4 US 2006/0006578 A1, published Jan. 12, 2006 (Ex. 1012, “Johnson”). 5 US 7,753,240 B2, issued July 13, 2010 (Ex. 1005, “Leoncavallo”). 6 US D586,184 S, issued Feb. 10, 2009 (Ex. 1006, “Miller”). A person having ordinary skill in the art would have had a bachelor’s degree in mechanical engineering or the equivalent coursework and approximately one year of experience with liquid-containing devices, with more work experience substituting for less education and vice versa. See PO Resp. 7 (citing Ex. 2009 ¶¶ 61–68). Because CamelBak simply paraphrases Trove’s slightly more detailed definition of the level of skill in the art, we adopt Trove’s definition, as it appears reasonable and consistent with the asserted prior art and the ’252 patent.” slip op. at 6

    Patent outcomesUS 8,905,252 not shown unpatentable
    Claim construction§ 102 anticipation§ 103 obviousness
    Patents in suitUS 8,905,252
  • PTAB · Oct 15, 2025 · PGR2025-00002 · APJ Frederick C Laney · PGR · Adverse judgment

    After Patent Owner disclaimed claims 1–78, the Board granted its motion for adverse judgment and terminated the post-grant review.

    RulingsAdverse judgment
    • Adverse judgmentAdverse judgmentGranted

      “Under our rules, “[a] party may request judgment against itself at any time during a proceeding,” which includes “[c]ancellation or disclaimer of a claim such that the party has no remaining claim in the trial.” 37 C.F.R. § 42.73(b)(2). See Arthrex, Inc. v. Smith & Nephew, Inc., 880 F.3d 1345, 1350 (Fed. Cir. 2018) (“there is no claim remaining for trial . . . when, as here, all of the challenged claims have been cancelled”). Thus, actions construed to be a request for adverse judgment include cancellation of patent claims such that a party has no remaining claim in the trial. 37 C.F.R. § 42.73(b)(2). Because Patent Owner has disclaimed all challenged claims such that no claims remain in the trial, we grant Patent Owner’s Motion to Terminate by Adverse Judgment.” slip op. at 2

    None
    Patents in suitUS 12,134,952

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.