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  • 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
  • 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
  • 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
  • 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
  • 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
  • PTAB · Jun 26, 2025 · IPR2024-00294 · APJ David Cotta · IPR · Final written decision

    Claims 1–20 are unpatentable; proposed substitute claims 21–24 are also unpatentable, so the contingent motion to amend is denied.

    RulingsFinal written decision
    • Skill levelSkill level patent owner adoptedDecided for patent owner

      “appear to be that Patent Owner specifies that the POSA’s knowledge and experience may include optical sensors and that the POSA 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 and both parties agree that the POSA would have a working knowledge of physiological monitoring technologies. Ex. 1003 ¶ 24; PO Resp. 11. We find the additional specificity of Patent Owner’s definition to be helpful. In addition, 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 ’507 patent. Accordingly, we adopt Patent Owner’s proposed definition of the person of ordinary skill in the art. 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))). We note that we would reach the same outcome under either definition of the POSA. Cf., PO Resp. 12 (asserting that Petitioner’s proposed definition is “flawed” but also asserting that “patentability is confirmed” “[r]egardless of the level of skill”).” slip op. at 14

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

      “Ex. 1007, 1528. The dispute between the parties focuses on whether D’Angelo was made available to attendees of the IEEE EMBS conference identified in this header and, if so, what effect that has.16 Accordingly, we begin our analysis by considering the conference.” slip op. at 42

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

      “understood Mendelson to disclose averaging signals. We do not find in Mendelson any discussion of summing or averaging signals. See generally Ex. 1011, 912–915. Our inability to find a teaching of averaging in Mendelson is consistent with the testimony of Drs. Kenny and Duckworth. Dr. Kenny testifies that “there is simply no disclosure in Mendelson itself of any summing or averaging of collected signals.” Ex. 1083 ¶ 23. And in his deposition, Dr. Duckworth was unable to identify any express disclosure of averaging in Mendelson. See Ex. 1087, 103:9–114:11 (confirming that certain aspects of his declaration testimony relating to averaging of signals are not discussed in Mendelson). Accordingly, Mendelson, standing alone, does not support that the POSA would have understood Mendelson’s Sensor Module to have output averaged signals” slip op. at 28

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

      “the PDA to read out ‘data that’s been stored’ (i.e., previously measured physiological data) even after the Receiver Module’s battery had died” because Mendelson’s Receiver Module lacks “a microSD card or other nonvolatile storage from which measured data could be ‘read out’ after its battery has died.” PO Resp. 37; see also Ex. 2037 ¶ 147 (testimony of Dr. Duckworth confirming that Mendelson’s system could not store data that could be read out after its battery died). Accordingly, Patent Owner argues the POSA “would not have been motivated to modify Mendelson’s Receiver Module to draw power from the PDA as proposed because doing so would not allow the PDA to ‘read out’ the previously ‘measured physiological data’ after the Receiver Module’s battery died.” PO Resp. 39.” slip op. at 60

    § 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 10,736,507
  • Apple Inc. v. Masimo CorporationSome claims unpatentable
    PTAB · Jun 25, 2025 · IPR2024-00290 · APJ Richard H Marschall · IPR · Final written decision

    Claims 1–3, 6, 11–17, 19, 21, 22, 27, 28, 32, 34, 36, 37, and 42–44 are unpatentable as obvious; claims 4, 18, and 20 were not shown unpatentable.

    RulingsFinal written decision
    • Skill levelSkill level patent owner adoptedDecided for patent owner

      “In our Institution Decision, we deemed the differences in the parties’ proposals not material due to their substantial overlap, adopted Patent Owner’s proposal for purposes of that Decision, noted that the outcome of the Decision would not change if we adopted Petitioner’s proposal, and instructed the parties to “explain the differences and their relevance to the patentability issues in this case, and state whether any issue in the case turns on those differences” if either party continued to propose differing proposals during trial. Inst. Dec. 10–11. After institution, neither party has explained the materiality of the differences in their proposals or argued that any issues in this case turn on those differences. Based on our review of the parties’ proposals, we find Patent Owner’s proposal consistent with the level of skill exemplified by the prior art of record and the disclosure of the ’223 patent. Accordingly, we apply Patent Owner’s proposal in our analysis in this Decision. See Okajima, 261 F.3d at 1355 (“[T]he prior art itself” may reflect an appropriate level 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))). The outcome of this Decision would not change if we applied Petitioner’s proposed definition.” slip op. at 9

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionDecided for petitioner
    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
    • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable

      “preponderance of the evidence that the combination of Naghavi, Hochstedler, and Burnes discloses all of the limitations in claim 1. b. Motivation to Combine After summarizing its proposed combination, Petitioner provides a number of reasons for combining the references. Pet. 9–17. Petitioner breaks its motivation to combine arguments into three separate categories that we address below. See id. at 13–17. Patent Owner raises a number of arguments in support of its contention that “a POSITA would not have been motivated to combine the references to replace a measured value of one parameter with the measured value of another parameter,” which we address in the context of Petitioner’s arguments below. See PO Resp. 44–57. Many of Patent Owner’s arguments rely on Patent Owner’s proposed claim constructions for “replaced” and “measured value,” which we do not adopt for the reasons discussed above. For example, the first sentence in Patent Owner’s argument contends that “Naghavi, Hochstedler and Burnes do not disclose using the same screen area to display two currently measured parameters,” but we do not read the claims as requiring the display of “two currently measured parameters” consistent with Patent Owner’s construction for “measured values.” See id. at 44 (citing Ex. 2042 ¶ 125). Such arguments lack weight given that we have rejected their premise, and although Patent Owner’s arguments are suffused with references to its claim constructions, we attempt to identify where Patent Owner does not rely on those constructions in our analysis below.” slip op. at 47

    Patent outcomesUS 8,190,223 mixed
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 8,190,223
  • PTAB · Nov 4, 2024 · IPR2023-00894 · APJ Robert A Pollock · IPR · Final written decision

    Claims 1–10 and 12–15 are unpatentable; claim 11 was not shown unpatentable. Substitute claims 16–25 and 27–30 are unpatentable over Mazur; claim 26 was not reached.

    RulingsFinal written decision
    • BurdenMixed

      “It is of the utmost importance that petitioners in the IPR proceedings adhere to the requirement that the initial petition identify ‘with particularity’ the ‘evidence that supports the grounds for the challenge to each claim.’” Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369 (Fed. Cir. 2016) (quoting 35 U.S.C. § 312(a)(3)). Here, however, not until its Reply does Petitioner belatedly suggest that Ferrante’s disclosure of bone screws with self-tapping ends equally meets the limitation of claim 10 (with respect to the first member) as with claim 11 (with respect to the second member), and that both claims are obvious in light of “evidence” from Ferrante “that it was well known to equip bone screws with self-tapping ends.” Reply 26–27. We do not discern these arguments in the Petition, and consider them waived. See Netflix, Inc. v. DivX, LLC, 84 F.4th 1371,1377 (Fed. Cir. 2023) (“While the Board should not take an overly mechanistic view of a petition and decline to address an argument because the petitioner did not present it with ideal vigor and clarity, the Board should also not have to decode a petition to locate additional arguments beyond the ones clearly made.”). In sum, Petitioner’s error in failing to first address limitations of claim 10 in the Petition specific to the Cognet/Ferrante combination indicates a failure to meet the particularity requirements for what must be in the petition and cannot be left to be filled in on reply. See 35 U.S.C. § 312(a)(3); 37 C.F.R. §§ 42.22(a)(2) (requiring, among other things, “a detailed explanation of the significance of the evidence”), 42.104(b)(4)–(5) (requiring that petition “specify where each element of the claim is found in the prior art patents or printed publication relied upon” and, regarding submitted evidence, state “the relevance of the evidence to the challenge raised, including identifying specific portions of the evidence that support the challenge”). Microsoft, 2022 WL 989403, at *6. Accordingly, Petitioner has not shown persuasively that claim 11 would have been obvious in light of Cognet and Ferrante for the reasons set forth in the Petition. slip op. at 41

    • Expert testimonyPetitioner expert creditedDecided for petitioner

      “We also find persuasive Mr. Dominguez’s explanation that one of ordinary skill in the art would have understood “bore” as including stepped diameter holes, sometimes described as a bore having a counterbore. See generally Ex. 1018 ¶¶ 4–29; Reply 3–10. Three of Mr. Dominguez’s illustrative examples are reproduced in the annotated figures below. The above figures show Mr. Dominguez’s annotated illustrations from the Jackson (Ex. 1019, Fig. 3), Brånemark (Ex. 1021, Fig. 4), and Ray (Ex. 1025, Fig. 1) references as discussed at paragraphs 10, 12, and 13, respectively, of Mr. Dominguez’s Second Declaration. With reference to the above figures, Mr. Dominguez testifies that “Jackson describes a bone repair set screw in which ‘[t]he bore 27 comprises a first bore section 31, a second bore section 32,’ etc. delineated by shoulders 41, 42, etc. (Ex. 1019, 5:24– 43)” (Ex. 1018 ¶ 10); “Brånemark describes an osseous implantation device having body 1ʺ with first and second holding portions 21ʺ, 31ʺ and ‘an inner through bore with a first portion 4ʺ in the first holding portion and a second portion 5ʺ in the second holding portion.’” Ex. 1021, 4:44–46” (id. ¶ 12); and Ray discloses surgical calipers including “handle 12 having ‘stepped cylindrical bore 14,’” wherein “[c]ollar 20 of a shaft inserted in the bore ‘rests against a step of the bore 14’ (2:14–15)” (id. ¶ 13). Patent Owner responds that Mr. Dominguez’s examples “that allegedly show a single bore encompassing two or more stepped-diameter holes or a counterbore . . . . are specific to these references and divorced from the disclosures of the ’166 patent.” Sur-Reply 7. Insofar as the ’166 patent makes no mention of the term “bore” outside the claims, and Mr. Dominguez’s examples are all taken from the field of orthopedic surgery, we do not find this argument persuasive. Patent Owner further appears to contend that exemplary references to a “cylindrical stepped down bore” or a “stepped cylindrical bore” are too specific to be within the scope of the term “bore.” Sur-Reply 7–8. As these terms merely describe species within a larger genus, and Patent Owner presents no cogent reason to exclude them, we do not find this argument availing. Relatedly, we are also not persuaded by Patent Owner’s argument that “the prior art treats a ‘bore’ as an element that is distinct from a ‘counterbore.’” Id. at 8. Rather, we credit Mr. Dominguez’s testimony that “[a] counterbore is not a structure unto itself, a counterbore is part of a larger structure” as exemplified by numerous examples including Laps (Ex. 1028 ¶ 33 (sensor assembly wherein “bore 16 includes a counterbore 18”)); Martinez (Ex. 1029, 3:61 (surgical cutting instrument wherein “bore 56 has a counterbore 64”)); Zang (Ex. 1030, 2:49 (bone anchor having a “bore [that] includes a counterbore”)); Ledet (Ex. 1022, 29:3–5 (vertebral fixation plate having “through holes . . . . countersunk, or counterbored to accommodate the head of a bone screw”)); Seo (Ex. 1031, 3:45 (chair leg employing “counterbored bore 23”)); and Exner (Ex. 1032, 2:16 (extrusion press including “counterbored axial bore 6”)). Ex. 1018 ¶¶ 17–23. That a reference may refer to a figure as showing “bore 103” with “counterbore 105 . . . formed on one end” does not indicate that they are distinct structures as Patent Owner contends, but merely that the focus of each term is directed to the entire bore or to a particular aspect of the bore, i.e., its counterbore. See” slip op. at 22

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Patent Owner subsequently proposed an alternative definition, as a person having “[a] Bachelor’s Degree in biomedical and/or mechanical engineering or similar training and . . . at least three years of experience with implant devices used for internal fixation of bones.” POR 5 (citing Ex. 2012 ¶¶ 32–33). According to Patent Owner, “[t]his hypothetical person would be capable of performing various design tasks and would understand the basic mechanical features and operation of orthopaedic implant devices [and] have an appreciation for orthopaedic fusion techniques and the medical issues and concerns faced by a doctor/surgeon charged when performing operations to implant orthopaedic devices.” Id. Despite some differences in wording, Patent Owner asserts (and Petitioner does not contest) that any “distinction between the parties’ proposed definitions of a POSITA does not affect the arguments set forth herein.” Id. (citing Ex. 2012 ¶ 34). Consistent with this view, we find the parties’ constructions equally applicable in light of the prior art of record and the disclosure of the ’166 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the 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)). We adopt, for convenience, Petitioner’s definition, but our analysis does not change depending on which of the two articulations are applied here. H.” slip op. at 12

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

      “one of ordinary skill in the art would understand that “bore,” as used in the context of claims 1 and 12, encompasses a multi-diameter passage, and in particular, one having stepped longitudinal cross sections such as that shown in Cognet’s Figure 1. See generally DI 11–13. For the reasons that follow, we conclude that one of ordinary skill in the art would have understood “bore” as such. Relying on the testimony of Mr. Dominguez, Petitioner initially proposed a construction of “bore” as “a usually cylindrical hole made by or as if by the turning or twisting movement of a tool.” Pet. 16 (citing Ex. 1002 ¶ 58). Petitioner’s proposal relied on Mr. Dominguez’s testimony that “[a] bore is a cylindrical hole made by the spinning rotation of a twist drill cutting tool. It is typically made by removing material from a solid or hollow object, similar to a tunnel or orifice.” Ex. 1002 ¶ 58. Pointing to its annotation of Cognet’s Figure 1, above, Patent Owner argued that that the term “bore” excludes a tunnel made by “two adjacent bores.” See Prelim. Resp. 21–25. In view of the then-available evidence, we provisionally construed “bore” as a hole or passage made by or as if by the turning or twisting movement of a tool such that its interior walls have cylindrical lateral cross-sections, and which do not exclude holes or passages having tapered or stepped longitudinal cross-sections. DI 13.” slip op. at 19

    Patent outcomesUS 11,298,166 mixed
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · Graham
    Patents in suitUS 11,298,166
  • 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
  • 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
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