• Kohler Co. v. Delta Faucet Co.All claims unpatentable
  PTAB · Feb 18, 2026 · IPR2024-00700 · APJ Jane E Inglese · IPR · Remand

  On remand, the Board held claims 1–24 unpatentable as obvious over the asserted prior-art grounds, including Tseng’s disclosure of side-emitted light under the Director’s construction.

  RulingsRemand decision

  • RemandOther

    “We have jurisdiction under 35 U.S.C. § 6. This Final Written Decision on Remand from Director Review is entered pursuant to 35 U.S.C. § 318(a). Having reviewed the complete trial record pursuant to the Director Review Order, we determine that Petitioner has shown, by a preponderance of the evidence, that the challenged claims are unpatentable.” slip op. at 3

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “For purposes of this Decision, we adopt Petitioner’s definition of a POSITA. Petitioner’s witness (Mr. Cook) qualifies as a POSITA under this definition, and, therefore, is qualified to opine from the perspective of a POSITA on technical matters included within the areas of expertise prescribed by the definition. As indicated above, Petitioner’s definition of a POSITA does not require education in the field of optics and professional experience designing or analyzing optical apparatus, unlike Patent Owner’s definition. We are aware, however, that Patent Owner’s witness (Dr. Klopp) has more extensive experience with optical systems and methods than Petitioner’s witness (Mr. Cook). Compare Ex 1003 ¶¶ 8–14, Ex. 2005, 39:21–59:17, with Ex. 2003 ¶¶ 3–20, Ex. 2004, 1–2, Ex. 1015, 10:22–13:25. Although Mr. Cook possesses excellent credentials in the field of mechanical engineering, his experience in the design and analysis of optical systems and methods is sparse and insubstantial compared to that of Dr. Klopp. Id. Due to this difference in experience levels, in instances where the witnesses express differing views on factual issues related to optical systems and methods, we accord more weight to Dr. Klopp’s testimony than to Mr. Cook’s.” slip op. at 9

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

    “The Director’s Order instructs us to adopt its interpretation of the recitation in claim 10 of “an outer illumination surface extending perpendicular to the longitudinal axis of the housing” (“the disputed limitation”) as being “satisfied by any amount of light emitted from the side surface.” Order 3. We, accordingly, construe the disputed limitation of claim 10 as a surface extending perpendicular to the longitudinal axis of the housing through which any amount of light is emitted from the side surface.” slip op. at 10

  Patent outcomesUS 10,393,363 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,393,363
• Apple Inc. v. Smith Interface Technologies, LLCNo claims unpatentable
  PTAB · Feb 10, 2026 · IPR2024-01116 · APJ Sharon Fenick · IPR · Final written decision

  Petitioner did not prove claims 1, 2, 27, 37, 58, 60–64, 67–79, 186, 187, 189, 191, 192, 197, 199–204, 208–216, 223, 225, or 230 unpatentable because the asserted combinations did not establish the claimed blurring …

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

    “(Ex. 1003), that a person of ordinary skill in the art (“POSITA”) would have had “a Bachelor of Science degree in computer science, computer engineering, electrical engineering, human-computer interaction, or a comparable field and at least two years of professional experience in the design and development of graphical user interfaces (GUIs), human-computer interfaces, or equivalents thereof,” and that “[a]dditional years of experience could substitute for an advanced-level degree (and vice-versa).” Pet. 6 (citing Ex. 1003 ¶¶ 29–30).” slip op. at 9

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

    “C. Claim Construction In these proceedings, there is no controversy that would require us to decide any claim construction issue. See 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))). D. Obviousness of Claims 2, 27, 37, 58, 60–64, 67–79, 186, 187, 189, 191,” slip op. at 10

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

    “obviousness of the menus in the Ahn-Chaudhri combination following a user’s finger as the user performs the dragging gesture to open the menu.” Pet. Reply 2 (citing 01119-Petition, 26–33, substantially identical to Pet. 32– 40). However, again, the Petition does not explain an alternative theory in which Chaudhri supplements Ahn’s menu functionality to move that menu onto the screen, as opposed to teaching visual cues provided by gradual changes of the display during a gesture or the visual cue that an unlock image may provide during the unlock gesture. See Pet. 14–18 (describing Chaudhri teaching “visual differentiation” or “transitioning an optical intensity” between a user-interface object and the background, based on, e.g., transparency), 35–40 (same). In Reply, Petitioner adds evidence to attempt to support its contention that the combination teaches a menu following a user’s finger during a dragging gesture, involving references to Chaudhri’s discussion of a visual cue, further discussing Chaudhri’s unlock image. Ex. 1005 ¶¶ 54, 62, 74–79, Figs. 5A-5C (cited at Pet. Reply 4–5). With respect to these citations and arguments, even if they had been timely presented in the Petition, we agree with Patent Owner that they do not articulate a modification of Ahn with Chaudhri or a motivation to combine. PO Sur-reply 6. Additionally, we agree that these embodiments of Chaudhri are distinct from the cited portions of Chaudhri discussed with respect to this theory in the Petition, which relate not to the movement of displayed graphics, but to variations of optical intensity and visual cues. Id. at 6–7. We evaluate the Petition’s arguments in light of Petitioner’s statement in Reply that they require a teaching regarding “menus . . . following a user’s finger as the user performs the dragging gesture.” Pet. Reply 2. To the extent that the Petition shows that the combination of Ahn and Chaudhri would show visual changes as the user performs a dragging gesture, these do not relate to the movement of a menu, but rather to other optical effects. Thus, as we do not find that the Petition supports an Ahn-Chaudhri combination in which a menu follows a user’s finger as the user performs the dragging gesture to open the menu, as Petitioner argues, we determine that Petitioner has not shown limitation 2.d of claim 2 taught or suggested by the combination of Ahn and Chaudhri according to this theory.” slip op. at 31

  • Strike new argumentNew argument disregardedDecided for patent owner

    “Petitioner argues that “even under [this] interpretation of Ahn, the only difference between Ahn and the claims is whether the animation occurs in direct correspondence with a user’s dragging gesture or after the dragging gesture is complete – a straightforward design choice if ever there was one.” Pet. Reply 3–4 (citing Ex. 1024, 99:16–108:20; Ex. 1023 ¶ 12). However, as Patent Owner argues (PO Sur-reply 7–8) this argument is presented in Reply and is an improper shift of theory from the Petition. Nevertheless, were we to consider it, we would not find it compelling; Dr. Terveen’s cited testimony repeats this bare statement and is not supported by any evidence or additional explanation. Ex. 1023 ¶ 12; see 37 CFR § 42.65(a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”); Xerox Corp. v. Bytemark, Inc., IPR2022-00624, Paper 9 at 15 (Aug. 24, 2022) (precedential) (assigning little weight to opinion testimony that “merely repeats” conclusory statements in a brief, without “cit[ing] any additional supporting evidence or provid[ing] any technical reasoning to support [the declarant’s] statement”).” slip op. at 29

  Patent outcomesUS 10,656,754 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 10,656,754
• Apple Inc. v. Smith Interface Technologies, LLCNo claims unpatentable
  PTAB · Feb 10, 2026 · IPR2024-01115 · APJ Sharon Fenick · IPR · Final written decision

  Apple did not prove claims 1, 2, 27, 37, 58, 60–64, 67–79, 186, 187, 189, 191, 192, 197, 199–204, 208–216, 223, 225, and 230 unpatentable over the asserted Ahn combinations.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for patent owner

    “In the Decision on Institution in each proceeding, we noted that Petitioner’s definition left it unclear whether the bachelor’s degree in the proposed definition would be considered by Petitioner to be “an advancedlevel degree,” and did not adopt the portion of the definition relating to the substitution of years of experience for a degree. Dec. on Inst. 15–16. Patent Owner “does not agree with all aspects of Petitioner’s proposed level of ordinary skill” but did not propose an alternative definition. PO Resp. 10–11. Patent Owner’s declarant, Dr. Rosenberg, adopted Dr. Terveen’s definition for the purposes of his declaration. Ex. 2018 ¶¶ 32–33. We again adopt the main portion of Dr. Terveen’s definition, and determine that one of ordinary skill in the art would have had “a bachelor’s degree in computer science, computer engineering, human-computer interaction, or a comparable field and at least two years of professional experience working with graphical user interfaces and applications for computers.” This definition is commensurate with the problems and solutions in the ’754 patent and prior art of record and is supported by declarant testimony.” slip op. at 9

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

    “C. Claim Construction In these proceedings, there is no controversy that would require us to decide any claim construction issue. See 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))). D. Obviousness of Claims 2, 27, 37, 58, 60–64, 67–79, 186, 187, 189, 191,” slip op. at 10

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

    “obviousness of the menus in the Ahn-Chaudhri combination following a user’s finger as the user performs the dragging gesture to open the menu.” Pet. Reply 2 (citing 01119-Petition, 26–33, substantially identical to Pet. 32– 40). However, again, the Petition does not explain an alternative theory in which Chaudhri supplements Ahn’s menu functionality to move that menu onto the screen, as opposed to teaching visual cues provided by gradual changes of the display during a gesture or the visual cue that an unlock image may provide during the unlock gesture. See Pet. 14–18 (describing Chaudhri teaching “visual differentiation” or “transitioning an optical intensity” between a user-interface object and the background, based on, e.g., transparency), 35–40 (same). In Reply, Petitioner adds evidence to attempt to support its contention that the combination teaches a menu following a user’s finger during a dragging gesture, involving references to Chaudhri’s discussion of a visual cue, further discussing Chaudhri’s unlock image. Ex. 1005 ¶¶ 54, 62, 74–79, Figs. 5A-5C (cited at Pet. Reply 4–5). With respect to these citations and arguments, even if they had been timely presented in the Petition, we agree with Patent Owner that they do not articulate a modification of Ahn with Chaudhri or a motivation to combine. PO Sur-reply 6. Additionally, we agree that these embodiments of Chaudhri are distinct from the cited portions of Chaudhri discussed with respect to this theory in the Petition, which relate not to the movement of displayed graphics, but to variations of optical intensity and visual cues. Id. at 6–7. We evaluate the Petition’s arguments in light of Petitioner’s statement in Reply that they require a teaching regarding “menus . . . following a user’s finger as the user performs the dragging gesture.” Pet. Reply 2. To the extent that the Petition shows that the combination of Ahn and Chaudhri would show visual changes as the user performs a dragging gesture, these do not relate to the movement of a menu, but rather to other optical effects. Thus, as we do not find that the Petition supports an Ahn-Chaudhri combination in which a menu follows a user’s finger as the user performs the dragging gesture to open the menu, as Petitioner argues, we determine that Petitioner has not shown limitation 2.d of claim 2 taught or suggested by the combination of Ahn and Chaudhri according to this theory.” slip op. at 31

  • BurdenNot shown unpatentable

    “(3) Conclusion For the reasons discussed above, Petitioner has not shown limitation 2.d to be taught, suggested, or otherwise rendered obvious by Ahn and Chaudhri. Thus, we determine that Petitioner does not show by a preponderance of the evidence that claim 2 would have been obvious over the combination of Ahn and Chaudhri.” slip op. at 32

  Patent outcomesUS 10,656,754 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 10,656,754
• Google LLC v. DH International Ltd.All claims unpatentable
  PTAB · Feb 10, 2026 · IPR2024-01322 · APJ Brian P Murphy · IPR · Final written decision

  Claims 1–20 are unpatentable as obvious over Mooney; the Board also found Mooney combined with Lee renders the disputed limitations obvious.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

    “A person of ordinary skill in the art (“POSITA”) at the time of the alleged invention of the ’294 patent would have had at least a bachelor’s degree in electrical engineering, or a related field, and at least two years of experience in design, development, and/or testing of network-enabled consumer devices, and familiarity with payment cards, or the equivalent, with additional education substituting for experience and vice versa. Pet. 2 (citing Lipoff Decl. Ex. 1003 ¶ 57). “Patent Owner agrees with the Petitioner on the level of ordinary skill in the art.” Resp. 4. Patent Owner adds that a POSITA would have had “at least three years of relevant industry or research experience in wireless communication between devices.” Id. (citing Ex. 2001 ¶¶ 26–29). Mr. Zaheer testifies that a POSITA “would” slip op. at 9

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

    “The claim language and specification define and describe an “activation cue” in functional terms: a data communication from an external source is received by the cell phone and recognized as an activation cue if it causes the switching element to be assigned its first (activated) state. Ex. 1001, 9:28–31, 9:42–46, 10:14–16, 13:55–60, 14:53–59, 15:4–6, 19:20–26. Patent Owner agrees that “upon an activation cue being received by portable electronic device 10, switching element 44b switches to its activated state.” Resp. 19 (quoting Ex. 1001, 10:14–16). The activation cue may be a predetermined bit sequence, a predetermined contactless data transmission, continuously emitted, pulsed, or punctual, but these are unclaimed non-limiting embodiments of the preferred form of data transmission. Id. at 9:25–26 (“for example a predetermined bit sequence”), 11:20–22 (“One example . . . emit an activation cue in the form of a predetermined contactless data transmission”), 14:65–15:3 (continuously emitted, pulsed or punctual cue). We will not read such preferred embodiments from the specification into claim language that is not so limited. See SuperGuide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 875 (Fed. Cir. 2004) (care should be taken “not to import into a claim limitations that are not part of the claim”); see also In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993) (“limitations are not to be read into the claims from the specification”); see also IQRIS Techns. LLC v. Point Blank Enterprises, Inc., 2025 WL 727717, *4 (Fed. Cir. 2025) (“It is the claims, not the preferred embodiments, that” slip op. at 15

  • Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)§112(f) does not applyDecided for petitioner

    “operatively linked to said electronic circuit” under 35 U.S.C. Section 112, sixth paragraph or not, the result is the same. We note there is no presumption of applying means-plus-function analysis to the switching element, because the limitation does not use the words “means for” that would mandate such claim construction treatment, and “switching” may invoke structure as well as function. See Williamson v. Citrix Online, LLC, 792 F.3d 1339, 1349–1350 (Fed. Cir. 2015) (en banc) (holding that “use of the word ‘means’ creates a presumption that § 112, ¶ 6 applies”). Regardless, we look to the meaning of the claim phrase at issue in view of the specification. We determine that the ’294 patent provides a clear, concise meaning for the switching element upon which both parties rely for construction. Patent Owner’s express agreement with Petitioner, that the claimed switching element is described in the ’294 patent as “any type of device allowing data to be conveyed according to alternate data conveyance operations in response to an activation cue being received by transceiver 18 or not,’” is particularly telling because it is not consistent with Patent Owner’s argument that the switching element means “switching of the data.” Resp. 7, 31 (citing Ex. 1001, 9:28–318). The claim language does not recite, and the specification does not describe, the switching element as a device that switches the data. Therefore, we determine the claimed “data conveyance switching element” means any type of switching device that allows data to be 8 We presume Patent Owner’s citation to “Exh. 2001, 9:28-31” on page 7 was intended to be a citation to the ’294 patent (Ex. 1001), as cited on page 31. whether or not an “activation cue” is received by the cell phone “cue receiver.”” slip op. at 21

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

    “[external] data exchange device” as a device with a data transceiver coupled to a circuit that carries out the function of exchanging data. Pet. 7–8 (citing Ex. 1001, 2:14–17, 4:7–14, 9:3–6; Ex. 1003 ¶¶ 67–68). As above, whether we construe the “[external] data exchange device” under 35 U.S.C. Section 112, sixth paragraph or not, the result is the same. Patent Owner, quoting the description of a data exchange device in the ’294 patent, contends that a “[external] data exchange device” “can be any sort of data exchange device comprising an electronic circuit (not shown) therein and a data transceiver 9a.” Resp. 8 (quoting Ex. 1001, 9:4–6). Patent Owner also responds to the Petition by clarifying that “[a]n external data exchange device is not a transceiver but a device with a transceiver.” Id. (citing Ex. 2001 ¶ 48). Petitioner argues in reply that Patent Owner does not contest Petitioner’s mappings of Mooney’s “cordless telephone base unit” or “cellular network infrastructure” to the claimed data exchange devices, such that no construction is necessary to resolve the dispute. Reply 5 (citing Resp. 16–37; Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011)). Limitations [1.c] and [1.d] recite “a first [second] data transceiver operatively linked to said electronic circuit [in the cell phone],” both of which are defined functionally as “for exchanging data between said electronic circuit [in the cell phone] and a first [second] external data exchange device over a first [second] communication link.” Nothing in the the other independent claims, further limits the form or function of the “[external] data exchange device,” although a device external to the cell phone may invoke additional structure. We determine the plain meaning of “[external] data exchange device” as claimed and described in the ’294 patent governs: any [external] device that comprises an electronic circuit and data transceiver for exchanging data with the electronic circuit in the cell phone over a communication link. slip op. at 22

  Patent outcomesUS 9,022,294 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 9,022,294
• GE Healthcare Ltd. v. The Johns Hopkins UniversityInstituted
  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
• Apple Inc. v. Advanced Coding Technologies LLCInstituted
  PTAB · Dec 4, 2025 · IPR2025-01103 · APJ Brian P Murphy · IPR · Institution

  The Board instituted IPR on claims 7–12 on all grounds, finding a reasonable likelihood that Lamkin and the asserted combinations render the claims obvious.

  RulingsInstitution decision

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

    “We have jurisdiction under 35 U.S.C. § 314, which provides that an inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Under § 314, the Board may not institute review on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). If the Board institutes a review, it unpatentability asserted for each claim.” 37 C.F.R. § 42.108(a). Upon consideration of the Petition, the Preliminary Response, and the evidence of record, for the reasons set forth below, we conclude the Petition demonstrates a reasonable likelihood that Petitioner would prevail in showing the unpatentability of at least one challenged claim in the ’101 patent. Accordingly, we institute an inter partes review of claims 7–12 of the ’101 patent.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “(“POSITA”), various factors may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC, Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (citing Custom Accessories, Inc. v. Jeffrey- not exhaustive but are merely a guide to determining the level of ordinary skill in the art.” Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). There is uncontested evidence in the record before us that reflects the knowledge and experience of a POSITA. For purposes of this Decision, we adopt the Petition’s formulation of the level of ordinary skill in the art, which is consistent with the description in the ’101 patent, the prior art of record, and the testimony of Dr. Zadok.” slip op. at 9

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Other

    “Petitioner contends that no claim terms need construction, but also contends that “claim interpretations on which this Petition depends are incorporated in and apparent from the prior art mapping analysis below.” Pet. 5. Patent Owner contends that Petitioner’s position contradicts the position Petitioner took in related district court litigation, particularly Petitioner’s district court constructions of means-plus-function limitations” slip op. at 10

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

    “Fiechter (Ground 1B) in the manner claimed in the ’101 patent with a reasonable expectation of success, which we find sufficient to satisfy the reasonable likelihood standard on the present record. Pet. 42–45 (citing Ex. 1003 ¶¶ 360–362, 372–382). The Petition also offers several motivations to combine Lamkin and Ito (Ground 1C) in the manner claimed in the ’101 patent with a reasonable expectation of success, which we also find sufficient on the present record. Pet. 49–52 (citing Ex. 1003 ¶¶ 383–401). The Preliminary Response does not challenge the Petition’s asserted motivations to combine Lamkin-Fiechter or Lamkin-Ito. Prelim. Resp. generally. On the present record at this stage of the proceeding, we determine the Petition sufficiently supports a motivation to combine Lamkin-Fiechter and Lamkin-Ito with a reasonable expectation of success for the reasons articulated in the Petition and Dr. Zadok’s cited declaration paragraphs.” slip op. at 21

  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,230,101
• Intel Corporation / Advanced Micro Devices, Inc. v. Advanced Cluster Systems, Inc.Instituted
  PTAB · Nov 19, 2025 · IPR2025-00915 · APJ Arthur M Peslak · IPR · Institution

  The Board instituted IPR on claims 1–30 on both asserted § 103 grounds, finding a reasonable likelihood that Petitioner would prevail.

  RulingsInstitution decision

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

    “to determine whether or not to institute an inter partes review. Paper 12, 2–3. We, thus, have authority, acting on the designation of the Director, to determine whether to institute an inter partes review under 35 U.S.C. § 314(a). See 37 C.F.R § 42.4(a) (2024) (“The Board institutes the trial on behalf of the Director.”). Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless the information presented in the Petition shows “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Considering the Petition, the Preliminary Response, and all supporting evidence, we conclude that the information presented in the Petition establishes a reasonable likelihood that Petitioner would prevail in its challenge of at least one claim of the ’621 patent as unpatentable. Pursuant to 35 U.S.C. § 314, we hereby institute an inter partes review of all challenged claims of the ’621 patent on the grounds stated in the Petition.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner, supported by Dr. Bajaj’s testimony (Ex. 1003 ¶¶ 24–27) submits that a person of ordinary skill in the art “would have been someone knowledgeable of and familiar with computer cluster systems and cluster computing techniques” in June 2006. Pet. 12. According to Petitioner, a person of ordinary skill in the art would have had a bachelor’s degree in computer science, computer engineering, electrical engineering, or an equivalent training, and approximately two years of experience working in the field of cluster computing or parallel processing and would be knowledgeable regarding high-level scientific computing languages. Additional work experience can substitute for specific educational background, and vice versa. Id. (citing Ex. 1003 ¶¶ 24–27). Patent Owner does not address Petitioner’s proposed level of ordinary skill in the art. See generally Prelim. Resp. For the purposes of this Decision, we adopt Petitioner’s undisputed level of ordinary skill in the art because it appears consistent with the problems address in the ’621 patent and the cited prior art. C. Claim Construction” slip op. at 10

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

    “Petitioner “submit[s] that no claim term requires express construction.” Pet. 12–13. Patent Owner does not address claim construction in the Preliminary Response. We determine, at this stage of the proceeding, that we need not construe any claim terms to resolve the controversy before us. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those 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))).” slip op. at 11

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

    “6. Printed Publication Status of Petitioner’s Asserted Prior Art The Federal Circuit instructs that “[t]o qualify as a printed publication, a reference ‘must have been sufficiently accessible to the public interested in the art.’” Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1348 (Fed. Cir. 2016) (citing In re Cronyn, 890 F. 3d 1158, 1160 (Fed. Cir. 1989)). “A reference will be considered publicly accessible if it was ‘disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it.” Id. (citing Kyocera Wireless Corp. v. Int’l Trade Comm’n, 545 F. 3d 1340, 1350 (Fed. Cir. 2008)). Further, the question of whether a document qualifies as a “printed publication” for the purposes of 35 U.S.C. § 102 “involves a case-by-case inquiry into the facts and circumstances surrounding the reference’s disclosure to a member of the public.” Medtronic, Inc. v. Barry, 891 F.3d 1368, 1380 (Fed. Cir. 2018) (citing In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004)). At this stage of the proceeding, Petitioner “must 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.” Hulu, LLC v. Sound View Innovations, LLC, IPR2018- 01039, Paper 29, 13 (PTAB Dec. 20, 2019) (precedential). The reasonable likelihood standard “is lower than the ‘preponderance’ standard to prevail in in a final written decision.” Id.” slip op. at 16

  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,563,621
• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  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
• Intel Corporation / Advanced Micro Devices, Inc. v. Advanced Cluster Systems, Inc.Instituted
  PTAB · Nov 7, 2025 · IPR2025-00913 · APJ Brian P Murphy · IPR · Institution

  The Board instituted review of claims 1–30 on all asserted grounds, finding a reasonable likelihood that claims 1–25, 27–28, and 30 are obvious over Menon, Trefethen, RS6000, and POEref.

  RulingsInstitution decision

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

    “In an inter partes review, the burden of persuasion is on the petitioner to prove ‘unpatentability by a preponderance of the evidence,’ 35 U.S.C. § 316(e), and that burden never shifts to the patentee.” In re Magnum Oil Tools Int’l Ltd., 829 F.3d 1364, 1375 (Fed. Cir. 2016) (quoting Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015)); see also Aqua Products, Inc. v. Matal, 872 F.3d 1290, 1306 (Fed. Cir. 2017 (en banc (quoting Magnum Oil)). A patent claim is unpatentable under 35 U.S.C. § 103(a) if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious to a person of ordinary skill in the art at the time the invention was made. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007) (quoting 35 U.S.C. § 103(a)). Obviousness is resolved based on underlying factual determinations, including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of ordinary skill in the art; and (4) objective evidence of nonobviousness, i.e., secondary considerations. Graham v. John Deere Co., 383 U.S. 1, 17– 18 (1966). A party who petitions the Board for a determination of obviousness must show that “a skilled artisan would have been motivated to invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” Procter & Gamble Co. v. Teva Pharms. USA, Inc., 566 F.3d 989, 994 (Fed. Cir. 2009) (quoting Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1361 (Fed. Cir. 2007)). We assess Petitioner’s evidence and argument according to the above- referenced obviousness standard. We determine that the Petition satisfies the reasonable likelihood of prevailing standard under 35 U.S.C. § 314(a). We begin our analysis with a discussion of the Menon, Trefethen, RS6000, and POEref references. slip op. at 15

  • Skill levelSkill level petitioner adoptedOther

    “In determining the level of ordinary skill in the art, various factors may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC, Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (citing Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986)). “These factors are not exhaustive but are merely a Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). There is uncontested evidence in the record before us that reflects the knowledge and experience of a POSITA. For purposes of this Decision, we adopt the Petition’s formulation of the level of ordinary skill in the art, which is consistent with the description in the ’034 patent, the prior art of record, and the testimony of both experts.” slip op. at 11

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

    “Petitioner relies on the ordinary and customary meaning of the claim terms consistent with the Phillips standard. Pet. 12–13 (citing 37 C.F.R. § 42.100(b)). The Petition addresses the construction of “peer-to-peer architecture” recited in independent claims 1 and 30 of the ’034 patent, a limitation we need not construe to decide the institution question. Id. at 13; Cir. 2011) (“[C]laim terms need only be construed ‘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)). Patent Owner contends that “no claim construction is required” to address the Petition’s asserted deficiencies. Prelim. Resp. 6. Patent Owner also contends, however, that the Petition relies on a “novel claim construction” of limitations [1.4.1] and [1.5.1]—“second [third] hardware processor with a plurality of processing cores”—to support Petitioner’s obviousness argument. Id. at 11–12.8 Patent Owner challenges the Petition’s reliance on “single core processors on different chips,” such as the Power3 single-core processors of the Symmetric Multi- Processor (“SMP”) configuration disclosed in the RS6000 reference, as a disclosure of limitations [1.4.1] and [1.5.1]. Id. Patent Owner contends that such single-core processors on different chips do not satisfy limitations [1.4.1] and [1.5.1] because the ’034 patent “claims only multicore processors.” Prelim. Resp. 5 (citing Ex. 1001, 7:15–27). Petitioner responds in part as follows: To the extent PO is implicitly arguing that RS6000’s “four, eight, twelve, or sixteen 375 MHz 630FP 64-bit processors” do not teach the recited “cores,” Patent Owner’s argument excludes embodiments described in the ’034 patent’s specification. The ’034 patent describes “[p]rocessor cores [as] generally independent microprocessors.” Ex.1001, 5:14–15. Patent Owner’s attempt to exclude RS6000 from the scope of the claims 8 Pursuant to the Board’s Order on Related Matter Updates (Paper 14), the parties filed the September 26, 2025 Claim Construction Order entered in the co-pending District Court litigation in this proceeding. Ex. 1085. The District Court Claim Construction Order did not construe the claim phrase “hardware processor with a plurality of processing cores.” Id. patent where the processor has independent microprocessors. Patent Owner’s attempt to distinguish RS6000’s Symmetric MultiProcessor as a “configuration” (Paper 8, 24) also fails because a “Symmetric MultiProcessor configuration” is no different than the ’034 patent’s description of a configuration of independent microprocessors. Id. Paper 9, 30.9 It is apparent there is a dispute over the plain meaning of Limitations [1.4.1] and [1.5.1], “a second [third] hardware processor with a plurality of processing cores,” recited in the independent claims.10 The parties are ordered to propose and support a particularized plain meaning or other construction of Limitations [1.4.1], [1.5.1], and [30.1.2] in their briefs. The parties are ordered to analyze the relevant claim language and cite to the specification and prosecution history in support of their claim construction, where applicable, with particular attention to the description of a hardware processor with a plurality of processing cores in the ’034 patent. See, e.g., Ex. 1001, 5:11–37, 7:14–36, 9:50–10:3.” slip op. at 12

  • Obviousness (§103) › Analogous artAnalogous artInstituted

    “Motivation to Combine and Analogous Art The Petition offers several motivations to combine Menon, Trefethen, RS6000, and POEref in the manner claimed in the ’034 patent with a reasonable expectation of success, which we find sufficient on the present record. The Petition first asserts that Menon and Trefethen are analogous prior art because they pertain to the same “field of cluster computing” as the ’034 patent and “are reasonably pertinent to the problem of the ’034 patent, namely, executing a single program on multiple nodes.” Pet. 22 (citing Ex.1001, 1:14–15; Ex.1003, ¶¶ 65–69; Ex. 1005, 2; Ex. 1006, Abstract). The Petition points out that Menon expressly cites and builds on the MultiMATLAB system taught by Trefethen. Id. (citing Ex. 1003 ¶ 71; Ex. 1005, 1–2). The Petition also contends that: Accordingly, Menon and Trefethen together represent a combination of prior art elements according to known methods (executing MATLAB code on a multiprocessor system) to yield the predictable result discussed in both papers: the MultiMATLAB system executing MATLAB in parallel to perform mathematical calculations. Id. at 22–23 (citing Ex. 1003 ¶ 70; Ex.1005, Abstract; Ex. 1006, 2–7). The Petition further contends that a POSITA would have found it predictable to combine Trefethen with Menon with a reasonable expectation of success” slip op. at 20

  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,570,034
• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  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

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.