• Neurent Medical Inc. / Neurent Medical Ltd. v. The Foundry, LLCAll claims unpatentable
  PTAB · Jul 21, 2025 · IPR2024-00279 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 1–3, 7, 9, 10, and 17–25 are unpatentable as obvious over Makower and Fang; the Board did not reach the other grounds.

  RulingsFinal written decision

  • Skill levelSkill level board ownPetitioner expert creditedDecided for petitioner

    “Based on the record before us, including the types of problems and solutions described in the ’675 patent and the cited prior art, we find a POSA would have had (1) a Doctor of Medicine (M.D.) or at least a bachelor of three years of experience in the clinical use, design, development, and/or testing of medical devices that deliver energy to tissue, and 3) knowledge and experience in treating nasal conditions, or access to a person with that knowledge and experience. Less work experience may be compensated by a higher level of education, and vice versa. In reaching our finding, we note that, although we agree with Petitioner that the ’675 patent discloses delivering neurotoxins to any target, and not just the nose, the claims of the ’675 patent are directed to methods of treating a nasal condition by delivering energy to the nasal cavity. Pet. Reply 30. Thus, to fill a gap between Petitioner’s POSA definition and the scope of the challenged claims, we add to Petitioner’s definition the requirement for knowledge and experience in treating nasal conditions, or access to a person with that knowledge and experience. We additionally add that a POSA’s educational background may include a bachelor of science degree in biomedical engineering or related discipline to reflect the nature of the field of invention. Nonetheless, we also note that our analysis and conclusions herein would not change even under Petitioner’s proposed skill level for a POSA. We do not agree with Patent Owner that prior experience designing or developing nasal medical devices is required for a POSA. PO Resp. 19. A definition inclusive of the clinical use, design, development, and/or testing of nasal medical devices that deliver energy to tissue is consistent with the skill level reflected in the disclosures of the ’675 patent and prior art. Consequently, we disagree with Patent Owner that Dr. Bu-Saba fails to qualify as a POSA because he lacks experience specific to designing medical devices. PO Resp. 19 n.4. Accordingly, we do not agree with Patent Owner” slip op. at 12

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “Second, we credit the testimony of the experts that, on balance, further confirms that skilled clinicians knew how to manage and remove fluids to the extent necessary. Dr. Bu-Saba testifies that typical steps for RF ablation procedures (even before 2006) included positioning the patient in a seated or slightly reclined position to facilitate the flow of any mucus or fluids away from the nasal cavity, application of topical decongestants, and “[i]n some circumstances,” if mucus or blood was still in the treatment area, “a 11 Nor does Patent Owner identify any disclosure in any other technical literature (either before or after 2006) expressing concerns that electrolytic fluids at the operative site could not be managed and/or would prevent targeted application of RF ablation energy to tissues at that site. See, e.g., Ex. 2003 ¶¶ 91–97 (testifying about the hypothetical “fluid” problem, but identifying no independent recognition of such a problem in any corroborating reference); Ex. 2005 ¶¶ 66–76 (same). visualization of the surgical site.” Ex. 1098 ¶¶ 81–89; Pet. Reply 14–15. Patent Owner’s expert, Dr. Levine, concurs that skilled clinicians knew how to remove mucus and other fluids, testifying that “[i]f [mucus] was obstructing my view” and “[i]f it was this thick . . . I might have to mechanically remove it with forceps, I might have to suction it, I might have to irrigate the nose with a saline solution to wash out the nose.” Ex. 1089 (Levine Tr.), 83:3–84:6 (admitting residual saline could either be swallowed or suctioned out); see also id. at 86:1–16 (testifying a patient may be positioned such that by “[v]irtue of gravity . . . fluid would fall to the bottom”).” slip op. at 33

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

    “Petitioner contends that, “[f]or purposes of this IPR, the Board need not construe any terms.” Pet. 18. Patent Owner responds that “the Board need not construe any terms to determine Petitioners have failed to carry their burden in this proceeding.” PO Resp. 20. On the record before us, we conclude that the claims need not be expressly construed to resolve the dispute before us. Insofar as the parties dispute the mapping of the prior art to dependent claim 22, we address that dispute below including, to the extent necessary, any implicit disagreement about the subject matter encompassed by claim 22.” slip op. at 14

  • Obviousness (§103) › Analogous artAnalogous artDecided for petitioner

  Patent outcomesUS 10,610,675 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 10,610,675
• Merck Sharp & Dohme LLC v. Halozyme, Inc.Instituted
  PTAB · Jul 11, 2025 · PGR2025-00009 · APJ Susan L C Mitchell · PGR · Institution

  The Board instituted PGR on claims 1, 2, 6–14, and 16–29, finding the written-description and enablement challenges met the institution threshold; the obviousness challenge did not.

  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, Preliminary Response, Reply, Sur-Reply, 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, 6–14, and 16–29 of the ’035 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 ’035 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 be an expert 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 10

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

  • Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateInstituted

    “On the current record, the evidence shows it is more likely than not that the claims of the ’035 patent fail to satisfy the written description requirement because they “recite a description of the problem to be solved while claiming all solutions to it and . . . cover any compound later actually invented and determined to fall within the claim’s functional boundaries— leaving it to the pharmaceutical industry to complete an unfinished invention.” Ariad, 598 F.3d at 1353. Accordingly, on the current record, we find that Petitioner has demonstrated that it is more likely than not that the ’035 patent does not comply with the written description requirement. Similarly, the current record does not appear to provide evidence of possession of the full scope of the claims of the ’035 patent in the ’731 application or any of the subsequent divisional or continuation applications leading to the ’035 patent that claim priority to the ’731 application (which appear to all have similar specifications) for the reasons given above.10 Therefore, the ’035 patent might not receive the benefit of priority to the earlier filed applications, and based on this preliminary determination, is eligible for post-grant review” slip op. at 30

  Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 12,123,035
• Geneoscopy, Inc. v. Exact Sciences CorporationAll claims unpatentable
  PTAB · Jul 9, 2025 · IPR2024-00459 · APJ Ryan H Flax · IPR · Final written decision

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

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

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

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

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

  • Expert testimonyOther

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

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

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

  Patent outcomesUS 11,634,781 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 11,634,781
• Apple Inc. v. Masimo CorporationSome claims unpatentable
  PTAB · Jul 3, 2025 · IPR2024-00290 · APJ Richard H Marschall · IPR · Final written decision

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

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “In our Institution Decision, we deemed the differences in the parties’ proposals not material due to their substantial overlap, adopted Patent Owner’s proposal for purposes of that Decision, noted that the outcome of the Decision would not change if we adopted Petitioner’s proposal, and instructed the parties to “explain the differences and their relevance to the patentability issues in this case, and state whether any issue in the case turns on those differences” if either party continued to propose differing proposals during trial. Inst. Dec. 10–11. After institution, neither party has explained the materiality of the differences in their proposals or argued that any issues in this case turn on those differences. Based on our review of the parties’ proposals, we find Patent Owner’s proposal consistent with the level of skill exemplified by the prior art of record and the disclosure of the ’223 patent. Accordingly, we apply Patent Owner’s proposal in our analysis in this Decision. See Okajima, 261 F.3d at 1355 (“[T]he prior art itself” may reflect an appropriate level of the ordinary level of skill in the art. (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). The outcome of this Decision would not change if we applied Petitioner’s proposed definition.” slip op. at 9

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

    “persuasive and reject Patent Owner’s argument that we should construe the limitation as requiring the absence of one parameter from the display prior to the replacement and the absence of the other parameter after the replacement. We do not view either requirement proposed by Patent Owner as justified based on our review of the claims, specification, and prosecution history.” slip op. at 16

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

    “preponderance of the evidence that the combination of Naghavi, Hochstedler, and Burnes discloses all of the limitations of claim 1 and that a POSITA would have been motivated to combine the references in the manner Petitioner proposes with a reasonable expectation of success. See Pet. 9–30. Accordingly, we determine that Petitioner proves by a preponderance of the evidence that claim 1 would have been obvious based on Naghavi, Hochstedler, and Burnes.” slip op. at 58

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

    “proposed combination based on the argument that a POSITA would have been motivated to switch the layout responsive to a parameter value changing. Pet. 11–15 (citing Ex. 1003 ¶¶ 35–40, 47–52). For example, we agree with Petitioner that a motivation exists to change the layouts to “best suit the condition of [the] patient” because Naghavi expressly describes an “interactive and dynamic” GUI that “may automatically detect changes in health status . . . and automatically react and rearrange the available options to best suit the condition” of the patient. Ex. 1005 ¶ 63. The supporting expert testimony persuasively relies on this aspect of Naghavi when concluding that “such a change in the severity of a parameter can indicate a change in the patient’s health that may require close monitoring” and a POSITA “would have been motivated to implement this approach of the combination in order to achieve” Naghavi’s objectives. Ex. 1003 ¶ 48 (citing Ex. 1005 ¶ 63); see also Pet. Reply 23 (“[T]he rearrangement of parameters, as already suggested by Naghavi and implemented according to Hochstedler, advantageously ensures an easy-to-use user interface, e.g., by highlighting information that has changed to warrant user attention.” (citing Pet. 13–14; Ex. 1003 ¶¶ 42–43)); Ex. 1003 ¶¶ 42–43.” slip op. at 51

  Patent outcomesUS 8,190,223 mixed
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,190,223
• Apple Inc. v. Willow Laboratories, Inc.All claims unpatentable
  PTAB · Jun 26, 2025 · IPR2024-00296 · APJ Alyssa A Finamore · IPR · Final written decision

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

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

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

  • Expert testimonyPetitioner expert creditedDecided for petitioner

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

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

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

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

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

  Patent outcomesUS 10,984,911 unpatentable
  Claim construction§ 103 obviousnesscites Phillips
  Patents in suitUS 10,984,911
• Apple Inc. v. Masimo CorporationSome claims unpatentable
  PTAB · Jun 25, 2025 · IPR2024-00290 · APJ Richard H Marschall · IPR · Final written decision

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

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “In our Institution Decision, we deemed the differences in the parties’ proposals not material due to their substantial overlap, adopted Patent Owner’s proposal for purposes of that Decision, noted that the outcome of the Decision would not change if we adopted Petitioner’s proposal, and instructed the parties to “explain the differences and their relevance to the patentability issues in this case, and state whether any issue in the case turns on those differences” if either party continued to propose differing proposals during trial. Inst. Dec. 10–11. After institution, neither party has explained the materiality of the differences in their proposals or argued that any issues in this case turn on those differences. Based on our review of the parties’ proposals, we find Patent Owner’s proposal consistent with the level of skill exemplified by the prior art of record and the disclosure of the ’223 patent. Accordingly, we apply Patent Owner’s proposal in our analysis in this Decision. See Okajima, 261 F.3d at 1355 (“[T]he prior art itself” may reflect an appropriate level of the ordinary level of skill in the art. (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). The outcome of this Decision would not change if we applied Petitioner’s proposed definition.” slip op. at 9

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

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

  Patent outcomesUS 8,190,223 mixed
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,190,223
• Gene Company Pty Ltd v. The Trustees Of Columbia University In The City Of New YorkNo claims unpatentable
  PTAB · Jun 23, 2025 · IPR2024-00313 · APJ Tawen Chang · IPR · Final written decision

  Claims 1–54 were not shown unpatentable because Petitioner failed to establish a reasonable expectation of success for the proposed combinations; objective indicia also supported non-obviousness.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “As to the first issue, we agree with Patent Owner that defining the level of skill in view of the solution described in the patent risks improper hindsight. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) 18 (“[T]he level of skill in the art is a . . . lens through which . . . the Board views the prior art and the claimed invention,” which “prevents . . . factfinders from using their own insight or . . . hindsight[] to gauge obviousness.”). We therefore do not include “practical knowledge about . . . the deuterium isotope effect, including the patents and publications discussed [in the Petition],” as part of our definition of a person of ordinary skill in the art.” slip op. at 18

  • Expert testimonyPetitioner expert creditedMixed

    “person of ordinary skill in the art would employ” in an obviousness analysis, we give some weight to Dr. Guengerich’s testimony. KSR, 550 U.S. at 418; Plantronics, Inc. v. Aliph, Inc., 724 F.3d 1343, 1354 (Fed. Cir. 2013) (explaining that “motivation to combine may be found. . . in . . . the background knowledge, creativity, and common sense of the person of ordinary skill”). Nevertheless, even if we were to agree that an ordinarily skilled artisan would have seen the 1,5-shift in NRPE in Mata’s A2E biosynthetic pathway as a particularly desirable location for intervention, we are not persuaded that such a person would have been motivated to substitute C20 deuterated vitamin A for the vitamin A in Ortho Pharma’s composition and method, because Petitioner has not shown, by a preponderance of evidence, that such an artisan would have reasonably expected the substitution to retard the accumulation of A2E or to treat macular degeneration.” slip op. at 42

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

    “In our Institution Decision, we preliminarily construed the preamble of claim 28 as limiting. Inst. Dec. 30–31. Petitioner did not take issue with our construction, or dispute Patent Owner’s construction of the preambles of claims 1 and 29 as also limiting. After consideration of the full trial record, we maintain our construction of the preamble of claim 28 as limiting for the reasons set forth in our Institution Decision. For similar reasons and the reasons set forth in Patent Owner’s Response, we further construe the preambles of claims 1 and 29 as limiting. See PO Resp. 12–14. We further determine that we do not need to construe any other claim term in order to resolve the controversy between the parties. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 26

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

    “415 F.3d 1303, 1312–19 (Fed. Cir. 2005) (en banc). Under this framework, claim terms are given their ordinary and customary meaning, as would be understood by a person of ordinary skill in the art, at the time of the invention, in light of the language of the claims, the specification, and the prosecution history of record. Id.” slip op. at 25

  Patent outcomesUS RE47,045 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
• Merck Sharp & Dohme LLC v. Halozyme, Inc.Instituted
  PTAB · Jun 11, 2025 · PGR2025-00004 · APJ Susan L C Mitchell · PGR · Institution

  The Board instituted PGR on claims 1–4, 7–19, and 22; it found written-description and enablement challenges likely to succeed, but the obviousness ground insufficient.

  RulingsInstitution decision

  • 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 ’298 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 be an expert in hyaluronidases. See Pet. 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. Moreover, Patent Owner fails to persuasively explain why Petitioner’s definition that includes a person with expertise in other enzymes is insufficient. Even if we were to apply Patent Owner’s POSA definition, it is not clear on the record before us that Petitioner’s experts lack relevant expertise or qualifications of at least a POSA. Patent Owner will have the chance to cross-examine Dr. Hecht and Dr. Park in this proceeding to develop a full record for us to determine the weight that each expert’s testimony should be given. Patent Owner will have further opportunity on a full record to assert that we should discount either experts’ testimony due to lack of appropriate qualifications. 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 petitioner

    “posttranslational modifications and those that do not contain chemical or posttranslational modifications.” Id. at 44:59–62. The ’298 patent provides an express definition of the term “modified PH20 polypeptide” which 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 47:15–30 (emphasis added).” slip op. at 14

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner

    “Under the second step of the Advanced Bionics framework, we must determine whether Petitioner has demonstrated Examiner error in a manner material to the patentability of the challenged claims. Advanced Bionics, at 10. Becton, Dickinson Factors (c), (e), and (f) inform our analysis at this step. Id. at 8.” slip op. at 21

  • 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, Preliminary Response, Reply, Sur-Reply, 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 1–4, 7–19, and 22 of the ’298 patent, and therefore, we grant post-grant review for the reasons articulated below.” slip op. at 2

  Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · Graham
  Patents in suitUS 12,018,298
• Precision Cancer Technologies Inc. v. Oncoustics Inc.Institution denied
  PTAB · Jun 3, 2025 · IPR2025-00242 · APJ David Cotta · IPR · Institution

  The Board denied institution on claims 1–20 because Petitioner did not show a reasonable likelihood of prevailing on any asserted anticipation or obviousness ground.

  RulingsInstitution decision

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

    “Under 35 U.S.C. § 314(a), inter partes review may not be instituted unless the Petition “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.” Petitioner has not established a reasonable likelihood of prevailing on its assertion that any of the challenged claims are unpatentable based on the grounds advanced here. Thus, for reasons explained below, we deny institution of inter partes review of claims 1–20 of the ’330 patent.” slip op. at 2

  • Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalDisclaimer foundDecided for patent owner

    “area” in the challenged claims was added by amendment. Ex. 1004, 181.8 In making the amendment, Applicant stated that the language added by amendment was intended to distinguish the pending claims over Uniyal,9 which Applicant characterized as disclosing a “time series” of ultrasound data. Uniyal relies on a time series of ultrasound data. In order to distinguish Uniyal, the claims have been amended to recite a single static set of ultrasound RF data in a single frame of the tissue area. As explained in the Interview, the claims rely on a signle [sic, single] “snapshot” frame of the ultrasound RF data rather than a time series or [sic, of] RF data as disclosed in Uniyal. Applicant respectfully submits the amended claims are allowable over all of the cited reference. Id. at 186–187; see also id. at 185 (Applicant’s remarks accompanying amendment, stating: “As explained in the Interview, a static set of raw ultrasound RF signals is collected for an area. This is a snapshot of the tissue area as opposed to taking a time series of RF signals”), 191 (Examiner interview summary, stating: “Inventor noted that Uniyal uses a time series US [ultrasound] data whereas the invention uses images that are non-coherent in time (e.g., a static frame)”).” slip op. at 9

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “transducer, Petitioner points to Hope-Simpson’s teaching that its neural network may be “capable of ‘analyzing patterns using a with a [sic] multi-dimensional (2-or more dimensional) data set, which may also be thought of as localized data sets.’” Id. at 22 (quoting Ex. 1005 ¶ 6; alteration by Petitioner). Petitioner then asserts that “[t]he localized data sets described by Hope-Simpson are equivalent to the claimed ‘single set of raw ultrasound [RF] data forming a single frame of a tissue area.” Pet. 22 (citing Ex. 1002 ¶ 86 (testimony of Dr. Papanicolau)). But Petitioner does not explain why Hope-Simpson’s “localized data sets” equate with a single frame of a tissue area rather than, for example, a time series of frames taken at the same location. Pet. 22. Petitioner cites the testimony of Dr. Papanicolau, but Dr. Papanicolau’s testimony lacks both technical reasoning and evidentiary support; it simply mirrors the statement in Petition. Ex. 1002 ¶ 86. For this reason, we give Dr. Papanicolau’s ipse dixit testimony little weight. Xerox Corp. v. Bytemark, Inc., IPR2022-00624, Paper 9 at 15 (PTAB Aug. 24 ,2022) (Decision Denying Institution) (precedential) (finding that conclusory testimony that “does not cite to any additional supporting evidence or provide any technical reasoning to support [that testimony] . . . is entitled to little weight”); see also, 37 C.F.R. § 42.65(a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”). Accordingly, to the extent this is the data that Hope Simpson provides to the processor, on this record, Petitioner has not sufficiently established that it constitutes a “single static set” of raw RF ultrasound data “forming a single frame.”” slip op. at 15

  Claim constructioncites KSR · Graham
  Patents in suitUS 11,602,330
• Merck Sharp & Dohme LLC v. Halozyme, Inc.Instituted
  PTAB · Jun 2, 2025 · PGR2025-00003 · APJ Jeffrey N Fredman · PGR · Institution

  Instituted PGR on claims 1–4 and 8–21 because the Board found a more-likely-than-not showing of written description and enablement failures; the obviousness ground did not meet that threshold.

  RulingsInstitution decision

  • 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 prior art relevant to the ’600 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 be an expert in hyaluronidases. See Pet. 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.” 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 48:38–53 (emphasis added). Based on this express definition, the current record does not support the interpretation of Dr. Triggs-Raine that the “term ‘modified PH20 polypeptide,’ therefore, has a purely structural meaning in the context of the specification.” Ex. 2001 ¶ 68.4 Indeed, when reproducing the definition from this column of the ’600 patent, Dr. Triggs-Raine does not include any text after the first period, but the ’600 patent text 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, 48:44‒46. On this” slip op. at 13

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for petitioner

    “on the ’429 patent, and there is no evidence of record that the Examiner meaningfully considered the relevant disclosures of the ’429 patent. We find unpersuasive Patent Owner’s reliance on the Examiner’s issuance of an office action with a written description rejection over a different issue that also included some double patenting rejections. As to Becton, Dickinson Factor (e), “whether Petitioner has pointed out sufficiently how the [E]xaminer erred in its evaluation of the asserted prior art,” Petitioner provides persuasive evidence of Examiner error. See Pet. 36–39 (citing Ex. 1009, 21–27). We agree with Petitioner that the Examiner overlooked the written description requirement with regard to claim 1. As discussed below, we find that, on the current record, the evidence sufficiently shows that it is more likely than not that the claims fail to comply with the written description requirement. See Section X. We, thus, find that the Examiner erred by either overlooking, or failing to appreciate, the factual underpinning necessary to support a written description for the breadth of an enormous genus claim such as claim 1 of the ’600 patent.” slip op. at 22

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

    “XIII. 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. XIV. 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 and 8–21 of the ’600 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 60

  Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · Graham
  Patents in suitUS 11,952,600

Holdings, summaries, rulings, issues, outcomes, winners and claim constructions shown for a decision were generated by a large language model reading the opinion. They are a guide to the decision, not the decision. Confirm every one against the court's own text before relying on it. Outcomes read from the patent owner’s side. Party names are extracted from the decision and are missing on about 900 short Director denials and scans, which carry the trial number instead.