• Geneoscopy, Inc. v. Exact Sciences CorporationAll claims unpatentable
  PTAB · Feb 5, 2026 · IPR2024-01330 · APJ Ryan H Flax · IPR · Final written decision

  Claims 3, 4, and 12–19 are unpatentable as obvious under each asserted ground.

  RulingsFinal written decision

  • Skill levelOther
  • Expert testimonyOther
  • Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner

    “embody claims of the ’746 patent, the product has features not covered by the ’746 patent’s claims, some of which are critical unclaimed elements according to Patent Owner. Accordingly, Cologuard is not coextensive with the challenged claims, and no nexus between the product and the challenged claims is shown on this record.” slip op. at 35

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

    “developed where the patient need not manipulate their fecal sample to portion it, but the law of obviousness does not require an option to be the best option to be obvious. For these reasons, bearing in mind that the ultimate burden here is always on Petitioner, we are not persuaded by Patent Owner’s argument. We also reject Patent Owner’s argument that only impermissible” slip op. at 60

  Patent outcomesUS 11,970,746 unpatentable
  § 103 obviousnesscites Phillips · Graham
  Patents in suitUS 11,970,746
• Petitioner v. Intent Iq, LLCAll claims unpatentable
  PTAB · Oct 14, 2025 · IPR2025-00129 · APJ Scott B Howard · IPR · Final written decision

  Claims 1–152 are unpatentable over the asserted prior-art grounds; the Board also struck Section II of Petitioner’s reply claim-construction brief.

  Nonecites Phillips · KSR · Graham
  Patents in suitUS 7,861,260
• Viant Techology LLC v. Intent Iq, LLCAll claims unpatentable
  PTAB · Oct 14, 2025 · IPR2024-00422 · APJ Scott B Howard · IPR · Final written decision

  The Board held claims 1–152 unpatentable based on the asserted obviousness grounds and struck Section II of Petitioner’s reply claim-construction brief.

  RulingsFinal written decision

  • BurdenFwd all claims unpatentableUnpatentable

    “Decision issues pursuant to 35 U.S.C. § 318(a). For the reasons that follow, we determine that Petitioner has shown by a preponderance of the evidence that the challenged claims are unpatentable.” slip op. at 2

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

    “1. “Contracted to Display a TV Ad Petitioner argues that the term means “contracted to display any form” slip op. at 14

  • Strike new argumentGranted

    “FURTHER ORDERED that Section II of Petitioner’s Reply Claim Construction Brief is stricken from the record; and” slip op. at 80

  Patent outcomesUS 7,861,260 unpatentable
  Claim constructioncites Phillips · KSR · Graham
  Patents in suitUS 7,861,260
• Viant Technology, Inc. v. Intent Iq, LLCAll claims unpatentable
  PTAB · Oct 14, 2025 · IPR2025-00128 · APJ Scott B Howard · IPR · Final written decision

  The Board held claims 1–152 unpatentable based on obviousness grounds and struck Section II of Petitioner’s Reply Claim Construction Brief.

  RulingsFinal written decision

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionDecided for patent owner

    “1. “Contracted to Display a TV Ad Petitioner argues that the term means “contracted to display any form” slip op. at 14

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

    “d) Conclusion Regarding Claim 1 For the reasons set forth above, Petitioner has demonstrated by a preponderance of the evidence that the subject matter of claim 1 would have been obvious over Baig, Costa, and Zwicky. 5. Analysis of Claims 2–5, 7–9, 12, 15, 17, 21, 22, 24, 26–28, 31, 32, 34, 37, 42, 44, 53, 54–58, 61, 62, 69, 71–80, 83, 84, 86–88, 91, 94, 96, 100, 101, 103, 106, 116–119, 122, 125, 128, 135, 137– 145, 147, 148, 151, and 152 Petitioner argues that the combination of Baig, Costa, and Zwicky teaches the limitations recited in claims 2–5, 7–9, 12, 15, 17, 21, 22, 24, 26–28, 31, 32, 34, 37, 42, 44, 53, 54–58, 61, 62, 69, 71–80, 83, 84, 86–88, 91, 94, 96, 100, 101, 103, 106, 116–119, 122, 125, 128, 135, 137–145, 147, 148, 151, and 152 and that a person having ordinary skill in the art would have combined the teachings with a reasonable expectation of success. Pet. 28–60; 422Pet. 29–51. Petitioner’s arguments are supported by citations to the prior art and the testimony of Mr. Lett. See Pet. 28–60; 422Pet. 29–51. We have reviewed Petitioner’s arguments and evidence, agree with them, and, therefore, adopt Petitioner’s arguments and evidence as our own. Patent Owner does not separately address those claims. See PO Resp.; 422PO Resp. Instead, Patent Owner only relies on the arguments discussed above for claim 1. See PO Resp. 13–16; 422PO Resp. 13–16. For the same reason as discussed above in Section II.D.4(b), we do not agree with Patent Owner’s arguments regarding the reason to combine the references. Accordingly, Petitioner has shown by a preponderance of the evidence” slip op. at 50

  • Strike new argumentNew argument disregardedGranted

    “F. Sua Sponte Striking Section II of Petitioner’s Reply Claim Construction Brief Our order allowing post-hearing claim construction briefing stated that “[t]he parties may not address any issues besides claim construction.” Paper 38, 1. Despite that order, Section II of Petitioner’s Reply Claim Construction Brief addresses obviousness under Patent Owner’s proposed construction. See Pet. Reply Post-hearing Br. 2–3 (Titled: “The Petition’s Obviousness Theory Renders Claims 121 and 146 Obvious Even Under Patent Owner’s Improper Construction.”). Because the section is in violation of our order, we sua sponte strike that section. See 37 C.F.R. § 42.12.” slip op. at 74

  Patent outcomesUS 7,861,260 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 7,861,260
• Viant Techology LLC v. Intent Iq, LLCAll claims unpatentable
  PTAB · Oct 14, 2025 · IPR2024-00421 · APJ Scott B Howard · IPR · Final written decision

  The Board held claims 1–152 unpatentable over the asserted prior art and struck Section II of Petitioner’s reply claim construction brief.

  RulingsFinal written decision

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

    “d) Conclusion Regarding Claim 1 For the reasons set forth above, Petitioner has demonstrated by a” slip op. at 50

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther

    “1. “Contracted to Display a TV Ad Petitioner argues that the term means “contracted to display any form” slip op. at 14

  • Strike new argumentGranted

    “F. Sua Sponte Striking Section II of Petitioner’s Reply Claim Construction Brief Our order allowing post-hearing claim construction briefing stated that “[t]he parties may not address any issues besides claim construction.” Paper 38, 1. Despite that order, Section II of Petitioner’s Reply Claim Construction Brief addresses obviousness under Patent Owner’s proposed construction. See Pet. Reply Post-hearing Br. 2–3 (Titled: “The Petition’s Obviousness Theory Renders Claims 121 and 146 Obvious Even Under Patent Owner’s Improper Construction.”). Because the section is in violation of our order, we sua sponte strike that section. See 37 C.F.R. § 42.12.” slip op. at 74

  Patent outcomesUS 7,861,260 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 7,861,260
• Geneoscopy, Inc. v. Exact Sciences CorporationAll claims unpatentable
  PTAB · Jul 9, 2025 · IPR2024-00459 · APJ Ryan H Flax · IPR · Final written decision

  Claims 1–20 are unpatentable as obvious under § 103 over each of the six asserted grounds.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “Here, as in our Institution Decision, we do not discern a significant difference between the parties’ respective proposed definitions beyond the number of years of experience after obtaining a doctoral degree. Compare Pet. 12, with Prelim. Resp. 47, and Resp. 19–20; see also DI 7–8. Under either proposed definition, the ordinarily skilled artisan would have been very highly skilled and educated. For purposes of this Final Decision, we maintain that Patent Owner’s definition appears to be reasonable (and it falls between Petitioner’s two definitions asserted in the reexamination request and in the Petition). Further, Patent Owner’s proposed definition appears to comport with the level of skill in the art reflected in the prior art of record and the ’781 patent itself, for example, Vilkin’s authors are a group of medical doctors and an editor of the journal is a PhD, Joost Louwagie, the named inventor of the ’781 patent, holds a PhD in Biochemistry, and the authors of Itzkowitz are medical doctors and PhDs. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“[T]he prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)); see Ex. 1005, 3 (list of authors); Ex. 1016 (Dr. Louwagie profile); Ex. 1055; see also generally Reply (Petitioner did not contest our similar determination at Institution). Therefore, we adopt and use Patent Owner’s definition of the ordinarily skilled artisan, set forth above. C.” slip op. at 13

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

    “Petitioner asserts that no claim construction is necessary in this proceeding. See generally Pet. Similarly, Patent Owner states that it “does not believe that claim construction is necessary to resolve patentability” in this proceeding. Resp. 21. “[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We agree with the parties that no construction of any claim term is necessary for purposes of our Final Decision. D.” slip op. at 14

  • Expert testimonyOther

    “Pet. 12. In support of these grounds for unpatentability, Petitioner relies on, inter alia, the 1st and 2nd Declarations of Duncan Whitney, PhD. Ex. 1002; Ex. 1080. In support of its positions, Patent Owner relies on, inter alia, the 1st and 2nd Declarations of Vadim Backman, PhD, and the Declaration of Peter Wood. Ex. 2001; Ex. 2022; Ex. 2023.” slip op. at 10

  • Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner

    “We have no reasonable doubt that aspects of the Cologuard product practice the invention of the ’781 patent’s claims 1 and 3, which are most generally directed to steps of collecting two portions of a fecal sample at home, and combining a respective buffer stabilizer/preservative with each of the two portions for claim 1, and then processing those fecal samples by testing for blood and nucleic acids (e.g., DNA) for claim 3. These appear to be nearly the most basic steps for using the Cologuard kit. See generally Ex. 2032. And, these steps do illustrate a certain ease of use and consumerfriendliness that may be a contributing factor in Cologuard’s success. See, e.g., Ex. 2022 ¶¶ 140–142, 155, 158–159, 170–171.” slip op. at 25

  Patent outcomesUS 11,634,781 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 11,634,781
• Apple Inc. v. Willow Laboratories, Inc.All claims unpatentable
  PTAB · Jun 26, 2025 · IPR2024-00296 · APJ Alyssa A Finamore · IPR · Final written decision

  Claims 1–4, 6, 8, 10–13, 15, 17, 19–21, 23–26, and 28 are unpatentable as obvious over Abdul-Hafiz and Raley, or over Abdul-Hafiz, Raley, and Secker.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “appear to be that Patent Owner specifies that the POSITA’s knowledge and experience may include optical sensors and that the POSITA may have a degree emphasizing software. We do not deem these differences material, particularly because the optical sensors and technologies at issue are those used in physiological monitoring technologies. Moreover, both parties agree that the POSITA would have a working knowledge of physiological monitoring technologies. Ex. 1003 ¶ 22; Ex. 2079 ¶ 37. Nonetheless, we find the additional specificity of Patent Owner’s definition to be helpful. Also, Patent Owner’s definition appears to be consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’911 patent. Accordingly, for purposes of this Decision, we adopt Patent Owner’s proposed definition of the POSITA. We note, however, that we would reach the same outcome under either definition of the POSITA. See also PO Resp. 12 (Patent Owner asserting “under any proposed level of skill, the claims’ patentability is confirmed for at least the reasons set forth below.”).” slip op. at 13

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “Dr. Kenny’s explanation finds support in Raley, and we find his explanation credible. Ex. 1079 ¶¶ 9–11. We agree that Raley’s opening 26 has a vertical depth. In order for emitters 21, 22, 23, 24 to be flush with opening 26 as depicted in Raley’s Figure 3 (see PO Resp. 17–18 (arguing that LEDs are flush with opening 26)), the opening must have a depth to accommodate the thickness of the emitters. We further agree that opening 26 is within a solid body, namely interconnect cable 20. We also agree that, in view of the structure and function of Raley’s probe 40 and interconnect cable segment 20, a POSITA would have understood opening 26 is designed to receive the emitters therein. Given that Raley’s interconnect cable segment 20 includes opening 26 that is designed to receive emitters 21, 22, 23, 24 therein, Petitioner has persuaded us that Raley’s LEDs are recessed into a cavity under both the plain and ordinary meaning of “cavity” and Petitioner’s construction from the Delaware Litigation.” slip op. at 27

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner

    “testimony regarding a POSITA’s understanding of Figure 11B of Abdul-Hafiz. Ex. 2079 ¶¶ 87–88. More pertinent to claim construction, however, is a POSITA’s understanding of the claim term in view of the Specification. See, e.g., Phillips, 415 F.3d at 1315 (“As we stated in Vitronics, the specification ‘is always highly relevant to the claim construction analysis. Usually, it is dispositive; it is the single best guide to the meaning of a disputed term.’” (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Circ. 1996))). In this regard, Petitioner points to Dr. Madisetti’s Rebuttal Expert Report, which was submitted on behalf of Patent Owner in the Delaware Litigation, where, upon reviewing the Specification of the ’911 patent for written description support for the claims, Dr. Madisetti testifies that “[a] POSITA would have known that the detection surface area of a given detector is essentially the entire surface area of the detector.” Ex. 1082 ¶ 912. During oral argument, Patent Owner attempts to reconcile the apparent inconsistency between this testimony and Patent Owner’s proposed construction. Tr. 34:20–36:12. In particular, Patent Owner asserts that, according to the ’911 patent Specification, the entire surface of the light-detecting side of the detector is the area that light reaches because there is “nothing blocking the entire area of the of the light-detecting side of the detector from receiving light.” Id. at 35:12–13. Patent Owner’s assertion, however, ignores EMI shield grid 2444 and foil 2450 that are placed on and at least partly cover the light-detecting side of the detector. Ex. 1001, 13:38–53, Fig. 24. Accordingly, we find Dr. Madisetti’s testimony regarding a POSITA’s understanding of the Petitioner’s construction, and we adopt Petitioner’s construction of “a detection surface area of the at least one detector” as the surface area of the light-detecting side of the detector.” slip op. at 16

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

    “reasons against it in the Sur-reply, we are persuaded that a POSITA would have found it obvious to modify Abdul-Hafiz’s aperture to have an area smaller than the detection surface area to prevent optical noise sources such as ambient light and piped light reaching the detector. We disagree with Patent Owner that Petitioner does not explain why a POSITA would have made Abdul-Hafiz’s aperture smaller than the detection surface area. Preventing optical noise sources explains why a POSITA would have made Abdul-Hafiz’s aperture smaller than the detection surface area because making the area of the aperture smaller than the detection surface area helps prevent optical noise sources from reaching the detector. Even if Abdul-Hafiz’s low noise housing 400 and fixed shield 1005 mitigate optical motivation to make something better. See Dystar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1368 (Fed. Cir. 2006) (“[W]e have repeatedly held that an implicit motivation to combine exists . . . when the ‘improvement’ is technology-independent and the combination of references results in a product or process that is more desirable, for example because it is stronger, cheaper, cleaner, faster, lighter, smaller, more durable, or more efficient.”). Adding an additional protection against optical noise by limiting the diameter of Abdul-Hafiz’s aperture would have enhanced the optical noise mitigation of the low noise housing and fixed shield. Moreover, apart from Abdul-Hafiz, Petitioner does not identify in the prior art an opening having a smaller area than a detection surface area. Petitioner, however, identifies a known relationship between the size of the opening relative to the detection surface area and preventing optical noise from ambient light and piped light. Pet. 50 (citing Ex. 1004 ¶¶ 3, 33); Reply 11–12 (citing Ex. 1011, 96–97, Fig. 6.6; Ex. 1079 ¶¶ 30–32; Ex. 1080 ¶ 73; Ex. 1081, 12:51–63, 14:19–47, 14:28–47). When one parameter is known to influence a specific result, such as the size of the opening relative to the detection surface area preventing optical noise, discovering the optimum value of the parameter is generally obvious. See In re Boesch, 617 F.2d 272, 276 (Fed. Cir. 1980) (“Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” (citing In re Antoine, 559 F.2d 618 (CCPA 1977); In re Aller, 220 F.2d 454 (CCPA 1955))). Furthermore, we agree with Petitioner that the proposed modification to Abdul-Hafiz, namely reducing the area of the aperture to be smaller than the detection surface area, is simple and that a” slip op. at 43

  Patent outcomesUS 10,984,911 unpatentable
  Claim construction§ 103 obviousnesscites Phillips
  Patents in suitUS 10,984,911
• Symrise AG / Symrise Inc. v. Inolex Investment CorporationAll claims unpatentable
  PTAB · Nov 1, 2024 · IPR2023-01035 · APJ Tina E Hulse · IPR · Final written decision

  The Board granted cancellation of claims 1–6, 8–10, and 22–28, and denied substitute claims 29–44 because Wright ’451 rendered them obvious.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner contends that a person of ordinary skill in the art at the time of the invention (“POSA” or “POSITA”) would have had “a bachelor’s degree and two or more years of experience or a master’s degree in organic synthesis or chemical engineering, with education substituting for experience and vice versa.” Pet. 15 (citing Ex. 1002 ¶ 16). Patent Owner took no position on the level of ordinary skill in the art in its Preliminary Response. Prelim. Resp. 8. In our Institution Decision, we adopted Petitioner’s definition. Dec. Inst. 6–7. In its Motion to Amend, Patent Owner states that it accepts the Board’s definition for purposes of this proceeding. MTA 24. We, therefore, see no reason to disturb our definition of the level of ordinary skill in the art as it appears to be consistent with the prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 8

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

    “Although neither party expressly proposes a construction for the term “conversion,” the parties appear to differ in their interpretations of that term. Petitioner interprets “conversion” to mean the percent conversion of the 1- alcohol. See Pet. Opp. RMTA 6–7 (interpreting “conversion” as percentage of remaining 1-alcohol); Ex. 1040, 109:2–11. Patent Owner, on the other hand, interprets “conversion” to mean the total percentage of alkenes that have been produced. Ex. 2010 ¶ 123 (interpreting “conversion” as percentage of total alkenes). During oral argument, counsel for Patent Owner conceded that “conversion can mean either.” Tr. 27:18–28:13. Without the benefit of briefing by the parties, we decline to expressly construe the term “conversion,” as our Decision would be the same under either interpretation, as discussed further below. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (finding only those terms that are in controversy need be construed, and only to the extent necessary to resolve the controversy). Moreover, we do not find it necessary to expressly construe any other claim terms for purposes of this Decision. Id.” slip op. at 10

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

    “2. Analysis A patent claim is unpatentable under 35 U.S.C. § 103 if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which said claimed invention pertains. See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on the basis of 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 skill in the art; and (4) objective evidence of nonobviousness. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). Objective evidence of nonobviousness may include” slip op. at 13

  • Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia outweighedDecided for petitioner

    “We are not persuaded. “[A]ny superior property must be unexpected to be considered as evidence of non-obviousness.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1371 (Fed. Cir. 2007). We must, therefore, first consider what results were expected to determine what a POSA would have considered to be unexpected. Id. As seen by the table below, Wright ’451’s disclosure fully encompasses the temperature ranges and purported unexpected results recited by substitute claim 29 and shown in Table 2 of the ’048 Patent: Reference Reaction Calcination Conversion Regioselectivity Rate13 Temperature Temperature Wright ’451 about 220 °C about 200 °C greater than about 90% to to about to 600 °C about 95% about 99% 440 °C Substitute 240 °C to about 420 °C at least 95% to about Claim 29” slip op. at 23

  Patent outcomesUS 10,995,048 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR
  Patents in suitUS 10,995,048
• Forte Biosciences, Inc. v. University Of MassachusettsAll claims unpatentable
  PTAB · Jun 24, 2024 · PGR2023-00014 · APJ Georgianna W Braden · PGR · Final written decision

  Claims 1–5 are unpatentable for lack of written description and enablement under § 112(a); the Board did not reach the § 103 challenge.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner does not contest Petitioner’s proposed definition, except to modify the level such that an ordinarily skilled artisan “would have been familiar with well-known inhibitors of IL-15 and IL-15R as described in the ’505 patent and recognized in the art as of April 2017.” Resp. 26–27 (citing Ex. 2005 ¶ 94). We adopt Petitioner’s level of ordinary skill in the art with Patent Owner’s proposed modification because it appears consistent with the problems addressed in the ’505 patent and the prior art of record.” slip op. at 7

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

    “this stage of the proceeding and that all terms are to given their plain and ordinary meaning. Pet. 23; Resp. 38. We agree. Construction is needed only for those terms “that are in controversy, and only to the extent necessary to resolve the controversy.” See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Here, we determine that no claim construction is necessary.” slip op. at 8

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable

    “Finally, we are reminded that “a sufficient description of the genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350. “[F]unctional claim language can meet the written description requirement when the art has established a correlation between structure and function.” Id. Here, however, the challenged claims are directed to methods using a wide range of different types of compounds purported to be “IL-15/IL-15R inhibitors” that are not part of a known or readily identifiable class, do not target the same biological pathway, do not have any common structural features, and do not appear to always function as inhibitors. See Ex. 1018, Abstr., 1575–77, 1579; Ex. 1046, 189:4–19, 191:15–192:15, 193:18–196:22, 198:21–199:21, 197:12–198:19, 200:1–8, 207:11–14, 203:3–10, 207:15–21, 236:12–24; Ex. 1047 ¶¶ 19–23, 56, 63–64, 80–85. Therefore, we find there is neither a representative number of species disclosed, nor a sufficient” slip op. at 21

  • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable

    “598 U.S. at 610. A “specification may call for a reasonable amount of experimentation to make and use a patented invention. What is reasonable in any case will depend on the nature of the invention and the underlying art.” Id. at 613. But the person of ordinary skill in the art cannot be left with merely “a hunting license” or obligated to engage in “painstaking experimentation” or “trial and error” to “see what works.” Id. at 614. Patent Owner argues that “the IL-15/IL-15R inhibitors disclosed in the specification were known in the art and “share the common ‘general quality’ of inhibiting a pathway known to be relevant to and having ‘particular fitness for the particular purposes’ of (id.) treating certain autoimmune diseases by blocking IL-15 signaling.” Sur-reply 14 (citing Ex. 1011, 22; Ex. 2013, 3; Ex. 2017, Abstr.; Ex. 2024, 17; Ex. 2025, 2–3, 6; Ex. 2027, 4; Ex. 2028, 9; Ex. 2029, 4; Ex. 2031, 23; Ex. 2118, 53:22–54:9; Ex. 1018, 1; Ex. 2005, ¶¶ 52–63, 80–83, 130; Ex. 1046, 231:20–25). Patent Owner’s argument is unavailing, however, because the record shows that different IL-15-specific inhibitors may operate in different ways that may result in differential effects, some of which may not include inhibition at all. See Ex. 1047 ¶¶21, 23, 40, 71; Ex. 1018, Abstr., 1576, 1579; Ex. 2013, 4:1– 8; Ex. 2014, 4:9–15; Ex. 2015 ¶ 22; Ex. 2025, 4:34–5:2; Ex. 1046, 166:21– 24, 168:25–169:5, 207:23–209:22, 210:4–17, 210:24–211:6; Ex. 1011, 1:67–2:4; Ex. 2005 ¶¶ 116, 134. Thus, we find that the record supports Drs. Abbas and Plott’s testimony, which we credit, that a person of ordinary skill in the art would be forced to hunt down and test every compound through painstaking Ex. 1002 ¶¶ 85–90, 92; Ex. 1047 ¶ 53 (Dr. Plott’s testimony that the “specification of the ’505 patent is essentially a black box (so far as which aspects of IL-15 signaling it inhibits and how it operates), leaving the reader to guess through trial and error which molecules might operate similarly to ChMBC7 and which do not.”); Ex. 1004 ¶ 61 (Dr. Plott’s testimony that “from the perspective of a clinician, the amount of experimentation required would be extremely burdensome and success would be speculative.”); Ex. 2007, 93:16–97:25, 38:208; Ex. 1046, 234:20–236:11. This is due to the fact that the claims (without limit) encompass any inhibition of any one of the various types of IL-15 signaling and various versions of the receptor, and even implicate other compounds that act on different targets but which inhibit the IL-15 signaling pathway. See Ex. 1047 ¶¶ 10, 53, 68; Ex. 2005 ¶ 71; Ex. 1046, 254:4–255:11, 158:12–160:20. The evidence has shown that IL-15/IL-15R inhibition is complicated and unpredictable, with some inhibitors also capable of enhancing forms of IL-15 signaling rather than preventing it. See Ex. 1047 ¶¶ 10, 25–26, 53; Ex. 2013, 2:10–18; Ex. 2014, 2:12–20; Ex. 2015 ¶ 3; Ex. 2025, 2:10–18; Ex. 2078, 267.” slip op. at 32

  Patent outcomesUS 11,278,505 unpatentable
  Claim construction§ 112 disclosurecites Phillips
  Patents in suitUS 11,278,505
• Samsung Bioepis Co. Ltd. v. Regeneron Pharmaceuticals, Inc.All claims unpatentable
  PTAB · Jun 14, 2024 · IPR2023-00442 · APJ John G New · IPR · Final written decision

  Claims 1, 3–11, 13, 14, 16–24, and 26 are unpatentable as obvious over Dixon because Dixon anticipates them.

  RulingsFinal written decision

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner

    “We adopt the same reasoning here, and conclude that the evidence of record and the Specification of the ’681 patent support construing the preamble’s recitation of a “method for treating a patient with an angiogenic eye disorder” as meaning administering a compound, i.e., the recited VEGF antagonist, to a patient for the purpose of improving or providing a beneficial effect in their angiogenic eye disorder. We find that, as in Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, although the claims “encompass a clinical result, they do not require such a result.” (emphasis added). 8 F.4th 1331, 1343 (Fed. Cir. 2021). We consequently reject Patent Owner’s proposed construction that the language of the preamble reciting a “method for treating an angiogenic eye disorder” requires not only an intent to treat, but, additionally, a high degree of efficacy on par with monthly Lucentis. See PO Resp. 9–10.” slip op. at 17

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

    “We adopt Petitioner’s proposed construction of the claim terms “initial dose,” “secondary dose,” and “tertiary dose.” Petitioner proposes adoption of the definitions expressly set forth in the Specification of the ’681 patent, viz., that the initial dose is the dose “administered at the beginning of the treatment regimen,” and is followed by the secondary doses that are “administered after the initial dose,” and the tertiary doses are “administered after the secondary doses” and may be distinguished from the secondary doses “in terms of frequency of administration.” Ex. 1001, col. 3, ll. 36–44. Patent Owner does not expressly dispute Petitioner’s construction, other than to argue that, by 2011, a person of ordinary skill in the art would have understood “initial” and “secondary” doses to correspond to loading doses and “tertiary” doses to correspond to maintenance doses. PO Resp. 13 (citing Ex. 2056 ¶ 66; Ex. 2349, 6–11. Patent Owner contends that the purpose (and expected effect) of loading doses was to achieve visual acuity gains and retina drying, and the goal of less frequent maintenance doses was to maintain the efficacy achieved with loading doses. Id. at 14 (citing Ex. 2056 ¶ 66). As we have explained above, we do not find persuasive Patent Owner’s argument that the definition of these terms requires a high, or otherwise defined, degree of efficacy. As we stated in the -00881 and -01225 Decisions: Based on those express definitions in the Specification, we do not find cause to construe the terms differently. In particular, we do not find that the Specification requires the “tertiary doses” to maintain any efficacy gain achieved after the initial and secondary doses, or that the term suggests any specific level of efficacy. The Specification unequivocally states that “[t]he terms ‘initial dose,’ ‘secondary doses,’ and ‘tertiary doses,’ refer to the temporal sequence of administration of the VEGF antagonist.”” slip op. at 18

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner

    “If a claim limitation is directed to printed matter, the second step of the Praxair analysis is to determine whether the printed matter is functionally related to its “substrate.” Praxair, 890 F.3d at 1032. Printed matter that is functionally related to its substrate is given patentable weight. Id. (citing DiStefano, 808 F.3d at 850). However, “[w]here the printed matter is not functionally related to the substrate, the printed matter will not distinguish the invention from the prior art in terms of patentability.” Id. (quoting In re Ngai, 367 F.3d 1336, 1339 (Fed. Cir. 2004)). More specifically, printed matter is functionally related to its substrate when the language changes not mere thoughts or outcomes, but provides action steps that the method requires. See C R Bard Inc. v. AngioDynamics, Inc., 979 F.3d 1372, 1381 (Fed. Cir. 2020) (holding that the test for printed matter is whether it “merely informs people of the claimed information, or whether it instead interacts with the other elements of the claim to … cause a specific action in a claimed process.”); see also Bristol-Myers Squibb Co. v. Ben Venue Laboratories, Inc., 246 F.3d 1368, 1376 (Fed. Cir. 2001) (stating that language “is only a statement of purpose and intended result” where its “expression does not result in a manipulative difference in the steps of the claim”) (emphasis added).” slip op. at 21

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “A Person of Ordinary Skill in the Art Petitioner notes that the Petitioner in the ’00881 IPR proposed that a person of ordinary skill in the art would have: (1) knowledge regarding the diagnosis and treatment of angiogenic eye disorders, including the administration of therapies to treat said disorders; and (2) the ability to understand results and findings presented or published by others in the field. Pet. 17–18 (quoting -00881 IPR, Paper 94 at 9–10). Furthermore, it was asserted that such a person would typically have an advanced degree, such as an M.D. or Ph.D. (or equivalent, or less education but considerable professional experience in the medical, biotechnological, or pharmaceutical field), with practical academic or medical experience in (i) developing treatments for angiogenic eye disorders, including through the use of VEGF antagonists, or (ii) treating of same, including through the use of VEGF antagonists. Id. at 18 (citing -00881 IPR Paper 94 at 10). Patent Owner does not expressly contest this definition of a person of ordinary skill in the art in its Response. In the -01225 IPR, we adopted the same definition of a person of ordinary skill in the art for the challenged claims of the ’681 patent, concluding that that definition was consistent with the level of skill in the art. See -01225 IPR, Paper 96 at 52–53. Having previously adopted this definition of the level of skill in the art for the claims of the ’681 patent, we do so again in the present proceeding.” slip op. at 25

  Patent outcomesUS 10,130,681 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,130,681

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.