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  • PTAB · Mar 4, 2026 · IPR2024-01281 · APJ Steven M Amundson · IPR · Final written decision

    Claims 1–3, 5–10, 12–15, and 17–21 are unpatentable as obvious over Cornett, Paatela, and Nelson; claim 8 is also unpatentable with Russell.

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

      “been motivated to combine the teachings of Cornett, Paatela, Nelson, and Russell in the way Petitioner proposes and would have had a reasonable expectation of success. See supra §§ III.E.2(a)–(b). Hence, Petitioner has shown by a preponderance of the evidence that claim 8 is unpatentable under § 103(a) because the claim would have been obvious over Cornett, Paatela, Nelson, and Russell.” slip op. at 122

    • Skill levelOther

      “B. Level of Ordinary Skill in the Art Factors pertinent to determining the level of ordinary skill in the art” slip op. at 13

    Patent outcomesUS 7,738,471 unpatentable
    § 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 7,738,471
  • PTAB · Jan 14, 2026 · PGR2025-00059 · APJ Devon Zastrow Newman · PGR · Institution

    The Board instituted post-grant review of claims 1–4 on all four asserted grounds, finding a sufficient preliminary showing of obviousness and lack of enablement.

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

      “V. CONCLUSION Petitioner has, at this stage, established that it will more likely than not prevail in showing that at least one of the challenged claims is unpatentable. This determination is, however, based on a preliminary record and is not final on any issues of patentability. We will make a final determination on the patentability of the challenged claims, as necessary and applying the preponderance of the evidence standard, based on a fully developed record through trial. VI. ORDER In consideration of the foregoing, it is hereby: ORDERED that, pursuant to 35 U.S.C. § 324(a) post grant review of claims 1–4 of the ’233 patent is hereby instituted on the grounds set forth in the Petition, commencing on the entry date of this Order, and pursuant to 35 U.S.C. § 324(d) and 37 C.F.R. § 42.4, notice is hereby given of the institution of a trial; and” slip op. at 40

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Patent Owner does not proffer a description of a POSA. See generally, Prelim. Resp. For the purposes of this decision, on the record at this time, we find that Petitioner’s definition appears consistent with the level of skill shown in the prior art references of record, and apply it herein. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). We invite the parties to further address the definition of a POSA during trial should they find it necessary.” slip op. at 7

    • Expert testimonyPetitioner expert discountedDecided for patent owner

      “In addition, the opinion stated in the Pomper Declaration that “the term of ‘low molecular weight’ is well accepted in the chemical arts” and the declarant “recognize[s] that low molecular weight compounds would have a molecular weight of typically from about 50 Daltons to about 1,500 Daltons” is offered by a co-inventor. We, as factfinder, have discretion to weigh the credibility of expert witnesses and to give each item of evidence such weight as appropriate. See In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”). In this case, we find that the published references on metabolites do not support the opinion. In re Am. Acad. of Sci. Tech Ctr., 367 F.3d at 1368 (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”) US-121, of which Dr. Pomper is lead inventor, also uses the term “low molecular weight”—without further characterization of the term—and is uninformative as to the meaning of the term. See Ex. 1006, ¶ 12. In addition, Patent Owner’s definition does not appear to apply to all compounds claimed in US-121.5” slip op. at 11

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

      “limited to Patent Owner’s proposed “from about 50 Daltons to about 1,500 Daltons.” The cited evidence relied on in the Pomper Declaration to define “low molecular weight” as a term well accepted in the chemical arts relates to metabolomics and metabolites. See Ex. 1002, 169, (specifically, ¶ 17 of Dr. Pomper’s declaration). Patent Owner admits that Dr. Pomper’s testimony is about molecules that differ from the claimed imaging and radiotherapeutic agents targeting FAP-α, but argues that the testimony is still relevant for purposes of explanation. Prelim Resp. 21. While it may be relevant, the testimony is not persuasive in light of the Specification. We find the uncontested fact that several of the B moieties alone—without the A moiety or L linker—specifically identified in the ’233 patent fall outside of Patent Owner’s proposed definition persuasive, as we normally do not interpret claim terms in a way that excludes examples disclosed in the specification. See, e.g., Verizon Servs. Corp. v. Vonage Holdings Corp., 503 F.3d 1295, 1305 (Fed. Cir. 2007) (rejecting proposed claim interpretation that would exclude disclosed examples in the specification). The cases cited by Patent Owner supporting that a claim term may be construed to exclude embodiments where the prosecution history supports such construction are factually distinguishable from the instant case as they regard instances of specific prosecution history disclaimer, clear prosecution disavowal, or relate to a specific definition of the terms in the Specification for the term being construed. Here, “low molecular weight” is not defined in the Specification, but, as Petitioner argues (see Pet. 21–25) is characterized as “demonstrat[ing] faster pharmacokinetics and a higher specific signal within clinically convenient times after administration” and that it “can be synthesized in radiolabeled form more easily.” Ex.1001, 13:33–50, 14:56– 16:14, 17:9–20. We are persuaded by the testimony of Dr. Zeglis, Petitioner’s declarant, that compounds weighing over 1500 Da may share those same behaviors, along with certain identified B moieties disclosed as embodiments. See Ex. 1003 ¶ 83.” slip op. at 10

    Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
    Patents in suitUS 12,115,233
  • PTAB · Dec 8, 2025 · IPR2025-01064 · APJ George R Hoskins · IPR · Institution

    The Board instituted IPR of claims 1–18 on all four §103 grounds, finding a reasonable likelihood that Volkswagen would prevail on at least claim 1 over Weese.

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

      “A. Legal Standards — Petitioner’s Burden “In an [inter partes review], the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the 1 Amendments to 35 U.S.C. § 103 enacted by the Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284 (2011) (“AIA”) took effect in March 2013. The ’353 patent issued from an application filed in September 2004. See Ex. 1001, code (22). Thus, we apply the pre-AIA version of § 103. grounds for the challenge to each claim”)). This burden of persuasion never shifts to the patent owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). B. Legal Standards — Obviousness A patent claim is unpatentable under 35 U.S.C. § 103(a) if the differences between the claimed subject matter and the prior art are such that the subject matter, as a whole, would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. 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 ordinary skill in the art; and (4) objective evidence of nonobviousness, if made available in the record, which has not happened here. See Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).” slip op. at 6

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “C. Level of Ordinary Skill in the Art Petitioner contends a person having ordinary skill in the art pertaining to the ’353 patent “would have possessed at least a four-year degree in physics, biophysics, medical physics, or a related field, and two years of experience in developing and/or applying computed tomography methods,” wherein “[a]dditional education and professional experience are interchangeable.” Pet. 1; Ex. 1003 ¶¶ 54–55. “Patent Owner utilizes Petitioner’s proposed level of skill in the art.” Prelim. Resp. 2. For purposes of this Decision, we adopt Petitioner’s formulation of ordinary skill in the art, as it appears to be consistent with the ’353 patent and the asserted prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 7

    • Expert testimonyOther

      “unpatentable as having been obvious over Weese, including supporting testimony from Dr. Peterson. See Pet. 17–22, 26–83; Ex. 1003 ¶¶ 138–149, 159–257. Patent Owner opposes. See Prelim. Resp. 1–2, 6–7. We conclude Petitioner has demonstrated a reasonable likelihood of prevailing on its assertions, as follows.” slip op. at 13

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

      “(iii) Analysis Based on the present record, we determine Petitioner’s contentions regarding the third step of claim 1 are supported sufficiently by the cited disclosures in Weese and Dr. Peterson’s testimony to justify institution of review. In particular, Weese describes obtaining a plurality of second images of the patient’s internal organs (i.e., PET image I0 in Fig. 1, and PET image I10 in Fig. 3) using a second imaging technique (i.e., PET). See Ex. 1005, Figs. 1, 3, and 6, ¶¶ 47–49, 58–59, 72. In particular, PET image I0 in Figure 1 may be a reconstructed “volume image[]” composed of a plurality of “quasi two-dimensional” “slice images” that, when combined, represent a three-dimensional region inside the patient. Id. ¶¶ 48, 58, 61; see also Pet. 56–57. PET image I10 in Figure 3 may be a similarly reconstructed volume image composed of a plurality of slice images.4 See 4 We do not rely here on Petitioner’s alternative theory that Weese discloses a “plurality” of second images because PET images I0 and I10 are “superposed” images encompassing “several states of motion.” Pet. 58. Ex. 1005 ¶¶ 61, 83–84. Patent Owner’s sole opposition to Petitioner’s assertions in this regard are limited to whether Weese “obtain[s]” PET images I0 and I10 as recited in claim 1, which we address below. Also, it appears that PET images I0 and I10 are obtained while also obtaining second movement measurements of the patient’s internal organs using a second sensor system (i.e., motion acquisition unit 12 and motion sensor 15 / S1) which is independent from the PET imaging technique. See Ex. 1005, Figs. 1 and 6, ¶ 65 (“[T]he respiratory motion is determined during the acquisition of the PET projections P1 by means of a respiratory motion sensor provided on the patient and therefrom the frequency function f(r) or, more generally, a state of motion function F1 is derived for the construction of the motion model M2.”). Furthermore, Weese describes how frequency function f(r) is utilized to facilitate image comparison between CT and PET images at common motion states. See id. ¶¶ 31, 49–51, 70–71, 75–77, 79–80, 83; see also Ex. 1003 ¶¶ 214–216 (Dr. Peterson’s supporting testimony). Patent Owner’s sole opposition to Petitioner’s assertions in this regard are limited to whether Weese “obtain[s]” PET images I0 and I10 as recited in claim 1, which we address below. Patent Owner’s two opposing arguments are unavailing, based on the present preliminary record. First, Petitioner relies on reconstructed PET images I0 and I10 as satisfying the “plurality of second images” recited in claim 1, not PET projections P1 from which PET images I0 and I10 are derived. See, e.g., Pet. 56, 58 (“I0 and I10 disclose and render obvious a ‘plurality of second images’ in two ways” — “I0 and I10 may be ‘volume images’ formed using ‘known’ techniques,” and “I0 and I10 are ‘superposed’ PET images encompassing ‘several states of motion,’ which” slip op. at 18

    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 8,265,353
  • PTAB · Dec 3, 2025 · IPR2025-01026 · APJ Steven M Amundson · IPR · Institution

    The Board instituted review of claims 1–20 on all petition challenges because the Baliarda-543 challenges met the reasonable-likelihood threshold.

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

      “to institute an inter partes review. We may institute an inter partes review only if “the information presented in the petition filed under section 311 and any response filed under section 313 shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2024). The “reasonable likelihood” standard is “a higher standard than mere notice pleading” but “lower than the ‘preponderance’ standard to prevail in a final written decision.” Hulu, LLC v. Sound View Innovations, LLC, IPR2018- 01039, Paper 29 at 13 (PTAB Dec. 20, 2019) (precedential). Based on the current record and for the reasons explained below, Petitioner has shown that there is a reasonable likelihood that it would prevail with respect to at least one of the challenged claims. Thus, we 1 Petitioner filed a confidential version of the Petition as Paper 3 and a public version of the Petition as Paper 4. We cite to the public version of the Petition. institute an inter partes review of claims 1–20 in the ’677 patent on all challenges included in the Petition.” slip op. at 2

    • Skill levelSkill level petitioner adoptedOther

      “Petitioner asserts that a person of ordinary skill as of the ’677 patent’s effective filing date would have had “at least a bachelor’s degree in electrical engineering, computer science, or a similar degree and at least four years of experience in applied electromagnetics with an emphasis on antennas.” Pet. 11 (quoting Ex. 1018 ¶ 32). Petitioner also asserts that “[a]lternatively, the person of ordinary skill in the art would have a master’s degree in electrical engineering (or similar discipline) and at least two years of similar experience.” Id. (quoting Ex. 1018 ¶ 32). Dr. van der Weide’s testimony supports Petitioner’s assertions. See Ex. 1007 ¶ 40. For purposes of the Preliminary Response only, Patent Owner employs Petitioner’s description of an ordinarily skilled artisan. Prelim. Resp. 17. Based on the current record and for purposes of this decision, we accept Petitioner’s description of an ordinarily skilled artisan because it comports with the technology and claims of the ’677 patent as well as the asserted references. See, e.g., Ex. 1001, 1:26–6:47, 42:47–44:61, code (57); infra §§ III.E.1–III.E.2.” slip op. at 23

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

      “4. DISCUSSION “[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.” Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999); see Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017). Based on the current record, we determine that no claim term, phrase, or limitation requires an explicit construction to decide whether Petitioner satisfies the “reasonable likelihood” standard for instituting trial.” slip op. at 26

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

      “Although “Dou does not require its ‘diversity antenna architecture’ to provide spatial diversity,” Dou nevertheless requires a wireless device with some type of diversity antenna architecture. See, e.g., Ex. 1013 ¶¶ 14, 17–18, 22–24, 30, 32–34, codes (54), (57), claims 1 and 16. As an example, Dou’s independent claim 1 covering a “wireless device” requires a “first diversity antenna” and a “second diversity antenna.” Id. at claim 1. As another example, Dou’s independent claim 16 covering a “wireless device” also requires a “first diversity antenna” and a “second diversity antenna.” Id. at claim 16. As yet another example, Dou’s Abstract describes a “wireless device” including a “first diversity antenna” and a “second diversity antenna.” Id. at code (57). Petitioner does not explain how the proposed combination provides anything other than spatial diversity. See Pet. 33–35; Prelim. Reply 1–3; Ex. 1007 ¶¶ 118–124. Based on the current record, we agree with Patent Owner that with Ciais-Quadband’s antenna used for Dou’s two antennas 206 and 208, the two identical quadband antennas would have:” slip op. at 46

    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
    Patents in suitUS 11,031,677
  • PTAB · Dec 3, 2025 · IPR2025-01027 · APJ Steven M Amundson · IPR · Institution

    The Board instituted IPR of claims 1–20 on all petition challenges, finding a reasonable likelihood that Baliarda-543 anticipates or renders obvious those claims.

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

      “to institute an inter partes review. We may institute an inter partes review only if “the information presented in the petition filed under section 311 and any response filed under section 313 shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2024). The “reasonable likelihood” standard is “a higher standard than mere notice pleading” but “lower than the ‘preponderance’ standard to prevail in a final written decision.” Hulu, LLC v. Sound View Innovations, LLC, IPR2018- 01039, Paper 29 at 13 (PTAB Dec. 20, 2019) (precedential).” slip op. at 2

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

      “Regarding spatial diversity, Dou explains that a first internal antenna and a second internal antenna “may be separated by a distance (D) that is no less than the quarter wavelength (>=λ/4) of the lowest frequency.” Ex. 1013 ¶ 24; see Ex. 2010 ¶¶ 35, 44. Consistent with Dou’s preference for at least a quarter-wavelength spacing between antennas at the lowest frequency, “a commonly accepted rule of thumb is that at least a quarter-wavelength spacing between antennas is necessary to provide effective spatial diversity.” Ex. 2010 ¶¶ 33, 35, 47. Effective spatial diversity requires sufficient spacing between antennas because that technique “uses multiple antennas to improve signal reliability and performance by mitigating the effects of multipath fading and other interference.” Ex. 2010 ¶ 33. “Multipath fading occurs when a wireless signal propagates along multiple different paths of differing lengths because of interactions with obstacles, resulting in portions of the signal energy arriving at a receiver with different phases slightly offset in time.” Id. Locations insufficiently separated in terms of wavelength “tend to experience similar fading and interference characteristics.” Id. Thus, closely spaced antennas “cannot provide effective spatial diversity.” Id. By providing sufficient spacing between antennas, however, “the likelihood increases that at least one of the antennas will be positioned at a location where the multipath or other interference is relatively low, thereby improving overall signal quality and reliability.” Id. As Patent Owner contends, the proposed combination modifies Dou’s ground plane 310 to replicate Jing’s ground plane with dimensions of 36 mm × 60 mm and limits “the extent of Dou’s ground plane 310 so that it [does] not extend behind Jing’s antenna at 306, just like Dou does not extend it behind antenna 308.” See Pet. 35–36; Prelim. Resp. 20 (quoting Pet. 35); Prelim. Sur-reply 1; Ex. 1007 ¶ 120; Ex. 2010 ¶ 45. The lowest frequency of Jing’s antenna is 900 MHz. Ex. 1011, 2657–58; see Ex. 1007 ¶¶ 118, 154; Ex. 2010 ¶¶ 37, 44. The wavelength (λ) corresponding to a frequency of 900 MHz is 333.3 mm, and a quarter wavelength (λ/4) is 83.3 mm. Ex. 2010 ¶ 44. In the proposed combination, a distance of 60 mm separates the” slip op. at 49

    • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateDecided for petitioner

      “To satisfy the written-description requirement, the inventor must have possession of the claimed invention as interpreted to encompass an allegedly infringing product. See Rivera, 857 F.3d at 1319–22; ICU Med., 558 F.3d at 1372–73, 1377–79. For purposes of the written-description requirement, the “invention” is “whatever is now claimed.” Vas-Cath, 935 F.2d at 1564 (emphasis omitted). Based on the current record, and as Petitioner asserts, LTE band 12 was not available for “use with mobile communications” or “use in any cellular communication, let alone LTE or 4G communication,” as of the ’429 application’s December 21, 2006, filing date. See Ex. 1007 ¶¶ 229, 231; Pet. 76–77. For instance, a Federal Communications Commission report adopted on July 31, 2007, notes that the 698-806 MHz spectrum “currently is occupied by television broadcasters in TV Channels 52-69.” Ex. 1045, 1, 3; see Ex. 1007 ¶ 231. The 698-806 MHz spectrum includes LTE band 12 with 698-716 MHz for uplink and 728-746 MHz for downlink. See Ex. 1026, 11 (Table 1); Ex. 1039, 498 (Table 20.1). At this stage of the proceeding, Patent Owner does not dispute that as of July 31, 2007, the 698-806 MHz spectrum was “occupied by television broadcasters in TV Channels 52-69.” See Prelim. Resp. 2–3, 23–30; Prelim. Sur-reply 5. Thus, based on the current record, Petitioner demonstrates a reasonable likelihood that as of the ’429 application’s December 21, 2006, filing date, the ’429 application did not “reasonably convey[] to those skilled in the art that the inventor had possession” of “an antenna configured to send or receive signals in the 698-806 MHz spectrum,” including LTE band 12 that Patent Owner relies on in the Geotab litigation, for “communication with any ‘4G communication standard’ because those frequencies were not usable for any mobile device communications at the time of filing.” See Pet. 78 (emphasis omitted); Ex. 1007 ¶¶ 231, 233–234, 236–237; Ex. 1045, 1, 3; Ariad, 598 F.3d at 1351. Accordingly, based on the current record, Petitioner demonstrates a” slip op. at 63

    • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportReference is prior artDecided for petitioner

      “To satisfy the written-description requirement, the inventor must have possession of the claimed invention as interpreted to encompass an allegedly infringing product. See Rivera, 857 F.3d at 1319–22; ICU Med., 558 F.3d at 1372–73, 1377–79. For purposes of the written-description requirement, the “invention” is “whatever is now claimed.” Vas-Cath, 935 F.2d at 1564 (emphasis omitted). Based on the current record, and as Petitioner asserts, LTE band 12 was not available for “use with mobile communications” or “use in any cellular communication, let alone LTE or 4G communication,” as of the ’429 application’s December 21, 2006, filing date. See Ex. 1007 ¶¶ 229, 231; Pet. 76–77. For instance, a Federal Communications Commission report adopted on July 31, 2007, notes that the 698-806 MHz spectrum “currently is occupied by television broadcasters in TV Channels 52-69.” Ex. 1045, 1, 3; see Ex. 1007 ¶ 231. The 698-806 MHz spectrum includes LTE band 12 with 698-716 MHz for uplink and 728-746 MHz for downlink. See Ex. 1026, 11 (Table 1); Ex. 1039, 498 (Table 20.1). At this stage of the proceeding, Patent Owner does not dispute that as of July 31, 2007, the 698-806 MHz spectrum was “occupied by television broadcasters in TV Channels 52-69.” See Prelim. Resp. 2–3, 23–30; Prelim. Sur-reply 5. Thus, based on the current record, Petitioner demonstrates a reasonable likelihood that as of the ’429 application’s December 21, 2006, filing date, the ’429 application did not “reasonably convey[] to those skilled in the art that the inventor had possession” of “an antenna configured to send or receive signals in the 698-806 MHz spectrum,” including LTE band 12 that Patent Owner relies on in the Geotab litigation, for “communication with any ‘4G communication standard’ because those frequencies were not usable for any mobile device communications at the time of filing.” See Pet. 78 (emphasis omitted); Ex. 1007 ¶¶ 231, 233–234, 236–237; Ex. 1045, 1, 3; Ariad, 598 F.3d at 1351. Accordingly, based on the current record, Petitioner demonstrates a” slip op. at 63

    § 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
    Patents in suitUS 11,349,200
  • PTAB · Nov 19, 2025 · IPR2025-00842 · APJ Steven M Amundson · IPR · Institution

    The Board instituted review of claims 1–10 and 12–20 on all petitioned grounds, finding a reasonable likelihood that at least one challenged claim would be unpatentable.

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

      “to institute an inter partes review. We may institute an inter partes review only if “the information presented in the petition filed under section 311 and any response filed under section 313 shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2024). The “reasonable likelihood” standard is “a higher standard than mere notice pleading” but “lower than the ‘preponderance’ standard to prevail in a final written decision.” Hulu, LLC v. Sound View Innovations, LLC, IPR2018- 01039, Paper 29 at 13 (PTAB Dec. 20, 2019) (precedential). Based on the current record and for the reasons explained below, Petitioner has shown that there is a reasonable likelihood that it would prevail with respect to at least one of the challenged claims. Thus, we institute an inter partes review of claims 1–10 and 12–20 in the ’084 patent on all challenges included in the Petition.” slip op. at 2

    • BurdenDecided for petitioner

      “The Board’s rules require that a petition provide “a statement of the precise relief requested for each claim challenged,” including “specify[ing] where each element of the claim is found in the prior art patents or printed publications relied upon.” 37 C.F.R. § 42.104(b)(4). The Board’s rules also require that a petition include “a detailed explanation of the significance of the evidence.” 37 C.F.R. § 42.22(a)(2). Contrary to Patent Owner’s assertions, the Petition satisfies these rules. See Pet. 1, 20–119. Under the heading “Statement of Precise Relief Requested,” the Petition provides the following table:” slip op. at 20

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “earliest priority date “would have had a Bachelor’s degree in electrical or computer engineering, or a comparable field of study, plus approximately two to three years of professional experience with acoustic technology.” Pet. 5. Petitioner also asserts that “[a]dditional graduate education could substitute for professional experience, and significant experience in the field could substitute for formal education.” Id. at 5–6. Dr. Kyriakakis’s testimony supports Petitioner’s assertions. See Ex. 1003 ¶¶ 34–35. For purposes of the Preliminary Response only, Patent Owner relies on the Petitioner’s description of an ordinarily skilled artisan. Prelim. Resp. 11. Based on the current record and for purposes of this decision, we accept Petitioner’s description of an ordinarily skilled artisan because it comports with the technology and claims of the ’084 patent as well as the asserted references. See, e.g., Ex. 1001, 1:12–3:62, 36:49–39:8, code (57); infra §§ III.E.1–III.E.2.” slip op. at 15

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

      “4. DISCUSSION “[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.” Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999); see Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017). Based on the current record, we determine that no claim term, phrase, or limitation requires an explicit construction to decide whether Petitioner satisfies the “reasonable likelihood” standard for instituting trial.” slip op. at 17

    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 11,197,084
  • PTAB · Nov 19, 2025 · IPR2025-00843 · APJ St John Courtenay III · IPR · Institution

    The Board instituted IPR on claims 1–12, 14, and 16–20 on all four grounds, finding a reasonable likelihood that claim 1 is obvious over Li and Liao.

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

      “review. See 35 U.S.C. § 314 (2024); 37 C.F.R. § 42.4(a) (2025). Under 35 U.S.C. § 314(a), we may not authorize an inter partes review unless the information in the petition and the preliminary response “shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” The “reasonable likelihood” standard is “a higher standard than mere notice pleading” but “lower than the ‘preponderance’ standard to prevail in a final written decision.” Hulu, LLC v. Sound View Innovations, LLC, IPR2018-01039, Paper 29 at 13 (PTAB Dec. 20, 2019) (precedential).” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “contends that a “person of ordinary skill in the art (“POSITA”) at the ’582 Patent’s earliest priority date (January 5, 2019), would have had a Bachelor’s degree in electrical or computer engineering, or a comparable field of study, plus approximately two to three years of professional experience with acoustic technology.” Pet. 6 (citing Ex. 1003 ¶¶ 34–36). Petitioner notes that “[a]dditional graduate education could substitute for professional experience, and significant experience in the field could substitute for formal education.” Id. At this stage, Patent Owner states that “[f]or the purposes of this Preliminary Response only, Patent Owner relies on the definition proposed by Petitioner because Petitioner has not shown that any challenged claims are unpatentable given this level of skill.” Prelim. Resp. 10. For purposes of this Decision on Institution, we adopt Petitioner’s definition of the level of ordinary skill in the art, because we are satisfied that it comports with the level of skill necessary to understand and implement the teachings of the ’582 patent and the asserted prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that the prior art itself can reflect an appropriate level of ordinary skill in art).” slip op. at 21

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

      “proposed combination of Li and Liao is based upon improper hindsight, because Patent Owner does not point to sufficient evidence of record that shows combining the teachings of the cited references in the manner proposed by the Petitioner would have been “uniquely challenging or difficult for one of ordinary skill in the art” or would have “represented an unobvious step over the prior art.” Leapfrog Enters., Inc. v. Fisher-Price, Inc., 485 F.3d 1157, 1162 (Fed. Cir. 2007) (citing KSR, 550 U.S. at 418).” slip op. at 32

    • Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner

      “Li teaches away from Petitioner’s proposed modifications to add a plug at each end of connecting component 113. See Prelim. Resp. 39, 41. A “reference does not teach away” if “it merely expresses a general preference for an alternative invention but does not ‘criticize, discredit, or otherwise discourage’ investigation into the invention claimed.” DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1327 (Fed. Cir. 2009) (quoting In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004)). Li expresses a general preference for connecting first housing 111 and second housing 112 to the two ends of first elastic metal wire 1131 in connecting component 113 by injection molding. Ex. 1004 ¶¶ 29, 35, dependent claims 2 and 7. For example, Li explains that “[o]ptionally, the first housing 111 and the second housing 112 are fixedly connected to both ends of the first elastic metal wire 1131 by injection molding.” Id. ¶ 29. Li does not “criticize, discredit, or otherwise discourage” using a plug to connect a housing to connecting component 113. See, e.g., id. ¶¶ 29, 35. Instead, Li discloses using plugs to mechanically connect components, i.e., to connect rear hook assembly 12 to “the first housings 111 of the two ear hook assemblies 11.” Ex. 1004 ¶ 58, Figs. 2, 9; see Ex. 1003 ¶¶ 57, 117, 122. Li similarly discloses using mechanical connectors comprising a clamping portion that engages with a locking portion to connect components, e.g., to “fix the first housing 111 and the third housing 114 together” and “fix the second housing 112 and the fourth housing 115 together.” Ex. 1004 ¶¶ 44–45. Li identifies these mechanical connectors as alternatives to adhesive bonding and “fasteners such as screws.” Id. ¶ 44; see id. ¶ 59 (identifying plugs as alternatives to “screw fixation”). Hence, we determine Li discloses a variety of ways to connect components in a bone conduction earphone but does not appear to “criticize, discredit, or otherwise discourage” any of those ways. See, e.g., Ex. 1004 ¶¶ 29, 35, 44–45, 58–59, Figs. 2, 9; see Ex. 1003 ¶¶ 57, 117, 121.” slip op. at 45

    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,310,582
  • PTAB · Nov 17, 2025 · IPR2024-00648 · APJ Devon Zastrow Newman · IPR · Final written decision

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

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

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

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

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

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

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

    • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

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

    Patent outcomesUS 11,643,462 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,643,462
  • PTAB · Nov 6, 2025 · IPR2024-00623 · APJ Devon Zastrow Newman · IPR · Final written decision

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

    RulingsFinal written decision
    • Expert testimonyPetitioner expert creditedDecided for petitioner

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

    • Skill levelSkill level board ownDecided for petitioner

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

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

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

    RulingsFinal written decision
    • Skill levelSkill level board ownDecided for petitioner

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

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

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

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

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

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

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

    Patent outcomesUS 11,325,975 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,325,975
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