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  • 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 · PGR2025-00053 · APJ Susan L C Mitchell · PGR · Institution

    The Board instituted PGR on claims 1–3 and 5–15, finding written-description and enablement challenges more likely than not to succeed, but not the obviousness challenge.

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

      “We have authority to determine whether to institute a post-grant review under 35 U.S.C. § 324. Institution of a post-grant review is authorized by statute when “the information presented in the petition . . . would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). Applying that standard on behalf of the Director (37 C.F.R. § 42.4(a)) and in consideration of the Petition and the cited evidence of record, we determine that the information presented shows that it is more likely than not that Petitioner would prevail in establishing unpatentability of claims 1–3 and 5– 15 of the ’773 patent, and therefore, we grant post-grant review for the reasons articulated below.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner’s proposal is sufficiently comprehensive to encompass the level of skill reflected in prior art relevant to the ’773 patent. It is reasonably clear that, in indicating that a POSA would have an advanced degree (like a Pet. 7. We have adjusted the claims challenged to only those that remain in effect following Patent Owner’s disclaimer. See Ex. 2003. 3 US 7,767,429 B2, issued Aug. 3, 2010 (the “’429 patent”; Ex. 1005). 4 Chao et al., Structure of Human Hyaluronidase-1, a Hyaluronan Hydrolyzing Enzyme Involved in Tumor Growth and Angiogenesis, 46 Biochemistry 6911–6920 (2007) (Ex. 1006). Ph.D.) and years of experience in analysis of protein structure, Petitioner is asserting that knowledge of proteins generally is sufficient to understand the types of problems encountered in the art and the prior art solutions to those problems, and the ordinary artisan need not have expertise specifically in hyaluronidases. See Pet. 16–17. Petitioner requires that the POSA would be able to apply key scientific concepts (e.g., biochemistry, recombinant biology, sequence analysis and protein modeling) to enzymes such as hyaluronidases. See id. At this stage of the proceeding and on the record before us now, we apply Petitioner’s proposed POSA level, which appears consistent with the level of skill shown in the prior art references of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007).” slip op. at 8

    • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for petitioner

      “refers to a PH20 polypeptide that contains at least one amino acid modification, such as at least one amino acid replacement as described herein, in its sequence of amino acids compared to a reference unmodified PH20 polypeptide. A modified PH20 polypeptide can have up to 150 amino acid replacements, so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity. Typically, a modified PH20 polypeptide contains 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50 amino acid replacements. It is understood that a modified PH20 polypeptide also can include any one or more other modifications, in addition to at least one amino acid replacement as described herein. Id. at 47:8–22 (emphasis added). On this record, however, we find that the definition of “modified PH20 polypeptide” permits amino acid replacements in the PH20 polypeptide but only “so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.” Ex. 1001, 47:13–15. Indeed, while some of the language in the above paragraph is permissive in nature, i.e.., describing the number of amino acid replacements a modified PH20 polypeptide “can have” or “[t]ypically . . . contains” or the other modifications the polypeptide “can include,” the phrase “so long as” is not. See Ex. 1001, 47:8–22. This distinction demonstrates that hyaluronidase activity is not an optional feature of a non-limiting example, but a requirement of the “modified PH20 polypeptide” defined and claimed in the ’773 patent. See Alynylam Pharms., Inc. v. Moderna, Inc., 138 F.4th 1326, 1333 (Fed. Cir. 2025) (explaining that the “contrast” between “non-limiting terms” and more definitive statements may indicate that the latter is definitional).” slip op. at 13

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

      “We determine that we need not expressly construe any other claim terms for the purpose of deciding whether to institute post-grant review. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 14

    Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
    Patents in suitUS 12,195,773
  • PTAB · Nov 19, 2025 · PGR2025-00050 · APJ Susan L C Mitchell · PGR · Institution

    The Board instituted PGR on claims 1–3 and 6–10 because Petitioner showed they were more likely than not to lack written-description support and enablement.

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

      “We have authority to determine whether to institute a post-grant review under 35 U.S.C. § 324. Institution of a post-grant review is authorized by statute when “the information presented in the petition . . . would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). Applying that standard on behalf of the Director (37 C.F.R. § 42.4(a)) and in consideration of the Petition and the cited evidence of record, we determine that the information presented shows that it is more likely than not that Petitioner would prevail in establishing unpatentability of claims 1–3 and 6– 10 of the ’791 patent, and therefore, we grant post-grant review for the reasons articulated below.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner’s proposal is sufficiently comprehensive to encompass the level of skill reflected in prior art relevant to the ’791 patent. It is reasonably clear that, in indicating that a POSA would have an advanced degree (like a Ph.D.) and years of experience in analysis of protein structure, Petitioner is asserting that knowledge of proteins generally is sufficient to understand the types of problems encountered in the art and the prior art solutions to those problems, and the ordinary artisan need not have expertise specifically in hyaluronidases. See Pet. 20. Petitioner requires that the POSA would be able to apply key scientific concepts (e.g., biochemistry, recombinant biology, sequence analysis and protein modeling) to enzymes such as hyaluronidases. See id. At this stage of the proceeding and on the record before us now, we apply Petitioner’s proposed POSA level, which appears consistent with the level of skill shown in the prior art references of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007).” slip op. at 9

    • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for patent owner

      “refers to a PH20 polypeptide that contains at least one amino acid modification, such as at least one amino acid replacement as described herein, in its sequence of amino acids compared to a reference unmodified PH20 polypeptide. A modified PH20 polypeptide can have up to 150 amino acid replacements, so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity. Typically, a modified PH20 polypeptide contains 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50 amino acid replacements. It is understood that a modified PH20 polypeptide also can include any one or more other modifications, in addition to at least one amino acid replacement as described herein. Id. at 47:4–18 (emphasis added). On this record, we find that the definition of “modified PH20 polypeptide” permits amino acid replacements in the PH20 polypeptide but only “so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.” Ex. 1001, 47:9–11. Indeed, while some of the language in the above paragraph is permissive in nature, i.e.., describing the number of amino acid replacements a modified PH20 polypeptide “can have” or “[t]ypically . . . contains” or the other modifications the polypeptide “can include,” the phrase “so long as” is not. See Ex. 1001, 47:4–18. This distinction demonstrates that hyaluronidase activity is not an optional feature, but a requirement of the “modified PH20 polypeptide” defined and claimed in the ’791 patent. See Alynylam Pharms., Inc. v. Moderna, Inc., 138 F.4th 1326, 1333 (Fed. Cir. 2025) (explaining that the “contrast” between “non-limiting terms” and more definitive statements may indicate that the latter is definitional). Thus, the evidence of record shows the ’791 patent recognizes a broad understanding of a “modified PH20 polypeptide” as encompassing PH20 sequences from a variety of different mammalian species, with or without precursor or signal sequences, with or without post-translational modifications, and with up to 150 amino acid replacements. The express definition of “modified PH20 polypeptide” in the ’791 patent permits up to 150 amino acid replacements but only “so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.” Ex. 1001, 47:9–11. That is, the provided definition of “modified PH20 polypeptide” in the ’791 patent expressly requires some hyaluronidase activity. On the current record, we therefore adopt the definition for “modified PH20 polypeptide” as recited in the ’791 patent to encompass polypeptides with some hyaluronidase activity. We determine that we need not expressly construe any other claim terms for the purpose of deciding whether to institute post-grant review. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 12

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

      “As we noted, on the current record claim 1 is reasonably interpreted to encompass PH20 polypeptides with some hyaluronidase activity. But even if we were to find that immunization using PH20 polypeptide as a contraceptive antigen serves to satisfy the utility requirement for the instant claims, there is a similar concern as to whether modified PH20 polypeptides with significant differences from the native protein as encompassed by claim 1 would maintain the antigenic determinants necessary to function as contraceptives. See Ex. 1003 ¶ 122. That the modified PH20 polypeptides would be homogenous in function is contradicted both by evidence in the ’791 patent itself and by Dr. Hecht and Dr. Parker. The ’791 patent discloses synthesis of 6,753 single amino acid mutations in residues 1‒447 of SEQ ID NO: 3. See Ex. 1001, 199:15–200:34. The ’791 patent teaches that just under 10% of these mutations, i.e. over 600, “exhibit activity that is increased compared to wildtype.” Id. at 233:1–2. Appendix A of Dr. Hecht’s Declaration shows 3,380 of these mutations were inactive, or 57.13%. See Ex. 1003, Appendix A-1, 171. Thus, the ’791 patent evidences that even when only a single mutation is made in the PH20 polypeptide, that single mutation is more likely than not to alter the structure in such a way as to inactivate the hyaluronidase activity found in the native PH20 polypeptide. On this record, Dr. Hecht persuasively demonstrates that when the full scope of claim 1 is addressed, which includes not just single mutations in the PH20 polypeptide, but also multiple mutations, there is no expectation of structural homogeneity, stating that “[i]ntroducing multiple amino acid changes simultaneously . . . could prevent the folding of sequences into secondary structures and structural motifs and can destabilize those structures if they do form.” Ex. 1003 ¶ 59. Dr. Hecht notes that claim 1 allows “up to 21 changes, with each additional change (except at position 309) being to any of 19 alternative amino acids. But the up to 21 changes also can be at any of 433 different positions.” Id. ¶ 129. Dr. Park calculates that the number of distinct polypeptides that meet the claimed criteria “is extremely large by all accounts, ranging from 1049 to 1060 distinct polypeptides.” See Ex. 1004 ¶ 161. Dr. Hecht characterizes the number of possible mutations as “astronomical in size.” Ex. 1003 ¶ 134.” slip op. at 20

    Claim construction§ 112 disclosure
    Patents in suitUS 12,077,791
  • 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 13, 2025 · PGR2025-00042 · APJ Susan L C Mitchell · PGR · Institution

    The Board instituted PGR on claims 1, 2, 5, and 7–33, finding likely written-description and enablement failures; it found the obviousness showing insufficient.

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

      “XII. CONCLUSION Petitioner has, at this stage of the proceedings, 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. XIII. 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, 2, 5, and 7–33 of the ’618 patent is hereby granted 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 46

    • Skill levelSkill level petitioner adoptedOther

      “Petitioner’s proposal is sufficiently comprehensive to encompass the level of skill reflected in prior art relevant to the ’618 patent. It is reasonably clear that, in indicating that a POSA would have an advanced degree (like a Ph.D.) and years of experience in analysis of protein structure, Petitioner is asserting that knowledge of proteins generally is sufficient to understand the types of problems encountered in the art and the prior art solutions to those problems, and the ordinary artisan need not have expertise specifically in hyaluronidases. See Pet. 15–16. Petitioner requires that the POSA would be able to apply key scientific concepts (e.g., biochemistry, recombinant biology, sequence analysis and protein modeling) to enzymes such as hyaluronidases. See id. At this stage of the proceeding and on the record before us now, we apply Petitioner’s proposed POSA level, which appears consistent with the level of skill shown in the prior art references of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007).” slip op. at 9

    • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner

      “On this record, however, we find that the entire text quoted above is part of the definition of “modified PH20 polypeptide” because it continues to detail specific elements required including a requirement that replacements in the PH20 polypeptide are permitted “so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.” Ex. 1001, 47:2–4; see Ex. 2001 ¶¶ 48, 67 (stating a “patent’s definition controls”). Indeed, while some of the language in the definitional paragraph is permissive in nature, i.e.., describing the number of amino acid replacements a modified PH20 polypeptide “can have” or “[t]ypically . . . contains” or the other modifications the polypeptide “can include,” the phrase “so long as” is not. See Ex. 1001, 47:1–11. This distinction demonstrates that hyaluronidase activity is not an optional feature of a non-limiting example as Patent Owner posits, but a requirement of the “modified PH20 polypeptide” defined and claimed in the ’618 patent. See Alynylam Pharms., Inc. v. Moderna, Inc., 138 F.4th 1326, 1333 (Fed. Cir. 2025) (explaining that the “contrast” between “non-limiting terms” and more definitive statements may indicate that the latter is definitional). Moreover, Dr. Triggs-Raine recognizes the “therapeutic use of hyaluronidases” and notes that “different hyaluronidases were known to have different functions and substrates.” Ex. 2001 ¶¶ 29, 113.6 That is, Dr. Triggs-Raine recognizes hyaluronidase activity as the primary utility for the modified PH20 polypeptides recited in claim 1.” slip op. at 13

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

      “Every patent must describe an invention. It is part of the quid pro quo of a patent.” Ariad, 598 F.3d at 1345. Ariad explains that for generic claims the question may still remain whether the specification, including original claim language, demonstrates that the applicant has invented species sufficient to support a claim to a genus. The problem is especially acute with genus claims that use functional language to define the boundaries of a claimed genus. In such a case, the functional claim may simply claim a desired result, and may do so without describing species that achieve that result. But the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus. Id. at 1349. Ariad explains “that an adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials.” Id. at 1350. Ariad also held that functional claim language can meet the written description requirement when the art has established a correlation between structure and function. . . . But merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species. Id. slip op. at 21

    Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
    Patents in suitUS 12,037,618
  • PTAB · Oct 16, 2025 · PGR2025-00052 · APJ Cynthia M Hardman · PGR · Institution

    The Board instituted PGR on claims 1–17 because the written-description and enablement challenges met the more-likely-than-not threshold; it found the indefiniteness and obviousness challenges insufficient.

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

      “We have authority to determine whether to institute a post grant review. See 35 U.S.C. § 324; 37 C.F.R. § 42.4(a). Considering the arguments and evidence presented, we institute a post grant review because Petitioner demonstrates “that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). The following preliminary findings of fact and conclusions of law are made solely to determine whether to institute review. Any final decision will be based on the full trial record.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “have had an undergraduate degree, a Ph.D., and post-doctoral experience in scientific fields relevant to [the] study of protein structure and function (e.g., chemistry, biochemistry, biology, biophysics). From training and experience, the person would have been familiar with factors influencing protein structure, folding and activity, production of modified proteins using recombinant DNA techniques, and use of biological assays to characterize protein function, as well with techniques used to analyze protein structure (i.e., sequence searching and alignments, protein modeling software, etc.). Pet. 16–17 (citing Ex. 1003 ¶¶ 13, 35–36). At this stage of the proceeding and on the record before us, we apply Petitioner’s proposed POSA level, which is presently undisputed and appears consistent with the level of skill shown in the prior art references of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007).” slip op. at 7

    • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownOther

      “The definition of “modified PH20 polypeptide” in the ’345 patent permits up to 150 amino acid replacements but only “so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.” Ex. 1001, 47:8–11. That is, the definition of “modified PH20 polypeptide” in the ’345 patent expressly requires some hyaluronidase activity. On the current record, we therefore adopt the definition for “modified PH20 polypeptide” as recited in the ’345 patent to encompass polypeptides with some hyaluronidase activity. The ’345 patent provides a specific definition of the term “hyaluronidase domain,” i.e., a “region of about 340 amino acids in length that corresponds to amino acid residues 38-374 of the precursor human PH20 sequence set forth in SEQ ID NO:6.”6 Ex. 1001, 68:19–24.” slip op. at 9

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

      “We determine that we need not expressly construe any other claim terms for the purpose of deciding whether to institute post grant review. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). Any final written decision entered in this case may include final claim constructions that differ from the preliminary understanding of the claims set forth above. Any final claim constructions will be based on the full trial record.” slip op. at 10

    Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham · Nautilus
    Patents in suitUS 12,264,345
  • PTAB · Oct 16, 2025 · PGR2025-00030 · APJ Susan L C Mitchell · PGR · Institution

    The Board instituted PGR on claims 1, 2, and 6–30 because Petitioner showed a reasonable likelihood of prevailing on written description and enablement; it did not show likely obviousness.

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

      “review under 35 U.S.C. § 324. Institution of a post-grant review is authorized by statute when “the information presented in the petition . . . would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). Applying that standard on behalf of the Director (37 C.F.R. § 42.4(a)) and in consideration of the Petition and the cited evidence of record, we determine that the information presented shows that it is more likely than not that Petitioner would prevail in establishing unpatentability of claims 1, 2, and 6–30 of the ’758 patent, and therefore, we grant post-grant review for the reasons articulated below.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Patent Owner’s contentions are, at this stage, unavailing because Patent Owner’s proffered definition of a POSA is too restrictive. Petitioner’s proposal is sufficiently comprehensive to encompass the level of skill reflected in prior art relevant to the ’758 patent. It is reasonably clear that, in indicating that a POSA would have an advanced degree (like a Ph.D.) and years of experience in analysis of protein structure, Petitioner is asserting that knowledge of proteins generally is sufficient to understand the types of problems encountered in the art and the prior art solutions to those problems, and the ordinary artisan need not have expertise specifically in hyaluronidases. See Pet. 15–16. Petitioner requires that the POSA would be able to apply key scientific concepts (e.g., biochemistry, recombinant biology, sequence analysis and protein modeling) to enzymes such as hyaluronidases. See id.” slip op. at 9

    • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for petitioner

      “refers to a PH20 polypeptide that contains at least one amino acid modification, such as at least one amino acid replacement as described herein, in its sequence of amino acids compared to a reference unmodified PH20 polypeptide. A modified PH20 polypeptide can have up to 150 amino acid replacements, so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity. Typically, a modified PH20 polypeptide contains 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50 amino acid replacements. It is understood that a modified PH20 polypeptide also can include any one or more other modifications, in addition to at least one amino acid replacement as described herein. Id. at 48:38–53 (emphasis added).” slip op. at 15

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

      “We determine that we need not expressly construe any other claim terms for the purpose of deciding whether to institute post-grant review. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Any final written decision entered in this case may include final claim constructions that differ from the preliminary understanding of the claims set forth above. Any final claim constructions will be based on the full trial record.” slip op. at 18

    Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
    Patents in suitUS 12,054,758
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