• Resmed Corp. v. Cleveland Medical Devices, Inc.All claims unpatentable
  PTAB · Jun 29, 2026 · IPR2025-00246 · APJ Cynthia M Hardman · IPR · Final written decision

  Claims 15–29 are unpatentable as obvious over the asserted combinations; the contingent motion to amend claims 30–41 is denied for lack of written-description support.

  RulingsFinal written decision

  • PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner

    “Patent Owner filed an authorized Motion to Terminate, alleging that Petitioner failed to name its corporate parent, ResMed Inc., as a real party in interest. Paper 39. Petitioner filed an opposition. Paper 42. Patent Owner filed a reply. Paper 43. We denied the Motion to Terminate. Paper 51.” slip op. at 3

  • Skill levelSkill level board ownOther

    “understanding of a person of ordinary skill in the art at the time the invention was made.10 See Graham, 383 U.S. at 17–18. The parties agree that a person of ordinary skill in the art (sometimes referred to herein as “POSITA”) would have had: at least a bachelor’s degree in mechanical engineering, electrical engineering, computer science, biomedical engineering, or a similar technical field, with at least two years of relevant product design experience working with diagnostic sensor systems and network data systems, such as networked PAP machines. Additional experience could substitute for less education, and additional education could likewise substitute for less experience. Pet. 3–4 (citing Ex. 1003 (Kirkness Decl.) ¶ 44); PO Resp. 4. 9 Patent Owner does not assert any objective indicia of nonobviousness. See generally PO Resp. 10 For purposes of this Decision, we apply a priority date of November 4, 2005. See supra n.4. Because the proposed level of ordinary skill in the art is consistent with the cited prior art and is undisputed on this record, we adopt it for purposes of this Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level).” slip op. at 9

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

    “Patent Owner does not persuade us to construe the term as “a value [or calculated value] that indicates how dire a patient’s symptoms are.” Patent Owner points to nothing in the intrinsic record that purportedly supports this construction, and we agree with Petitioner that “the patent specification’s disclosures regarding determining a level of symptom severity are broad, establishing that it can generally be derived from any sensor data and/or breathing events.” Pet. Reply 3–4; see also Ex. 1001, 3:44–46 (“Signals from the[] sensors are then analyzed to determine the level of severity of the symptoms of the subject’s sleep disorder.”). Patent Owner relies only on expert declarations to support its construction. But as indicated by the Federal Circuit, extrinsic evidence is “less significant than the intrinsic record in determining ‘the legally operative meaning of claim language.’” Phillips v. AWH Corp., 415 F.3d 1303, 1317 (Fed. Cir. 2005). This is especially applicable here, where neither Dr. D’Ambrosio’s nor Dr. Schwartz’s declaration was prepared for this proceeding, and neither declarant was subject to cross examination on their opinions. Moreover, neither of the declarants was opining on claim construction; rather, they were addressing indefiniteness and/or written description issues. See Ex. 1058 at 7 (heading addressing definiteness); Ex. 2026 at 18 (heading addressing written description). Further, Dr. Schwartz appears to have been making an argument about certain patent claims (not the challenged ’333 patent) based on Patent Owner’s own statements made during prosecution of a separate patent application. See Ex. 2026 ¶ 47 (“[T]he similar term used in the ’284 patent claims (‘data of severity of sleep disorder symptoms’) does not find written description support in the specification by a disclosure of the same statistics disclosed in Wright, because CleveMed argued those statistics are not related to severity of sleep disorder symptoms.” (emphasis added)). Patent Owner has not persuaded us that Dr. Schwartz’s testimony has direct applicability to the claim term at issue here. Dr. Borkholder’s testimony is likewise unpersuasive. Aside from citing Dr. D’Ambrosio’s and Dr. Schwartz’s declarations, Dr. Borkholder cites Exhibits 2027 and 2016. These exhibits discuss indices such as AHI and RDI that are used to assess the severity of a patient’s symptoms, but Patent Owner has not adequately explained how they bear on construction of the claim term at issue here, which is not addressed in these exhibits. Ex. 2022 ¶¶ 32–33. Accordingly, we accord Dr. Borkholder’s claim construction opinions little weight, because they are unsupported by reference to objective, corroborating evidence of record. See, e.g., Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 294 (Fed. Cir. 1985) (“Lack of factual support for expert opinion going to factual determinations . . . may render the testimony of little probative value in a validity determination.”); Xerox Corp. v. Bytemark, IPR2022-00624, Paper 9, 15 (PTAB 2023) (precedential) (explaining that declaration testimony that “is conclusory and unsupported” and which “adds little to the conclusory assertion for which it is offered to support . . . is entitled to little weight”).” slip op. at 23

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

    “We find that Petitioner has the better argument. Tidal volume refers to “the volume of air that is inspired or expired during a respiratory cycle.” Ex. 2028, 13–14; PO Resp. 10. “[H]ypopnea events are defined as a reduction of ≥50 % or 74 % in tidal volume from baseline and apnea events as absence of tidal volume for at least 10s.” Ex. 2028, 13–14 (emphasis omitted). Toge teaches that a control unit analyzes collected data (e.g., the flow rate) and calculates tidal volume. Ex. 1044 (Toge) ¶¶ 34–38. The calculated tidal volume is “a quantified level of severity data based on the subject’s sleep apnea symptoms during the therapy” because it represents, e.g., the “level of airway obstruction the patient experiences during the sleep apnea treatment using the PAP device.” Pet. 15. As Dr. Chatterjee explains: Toge discloses that tidal volume Fp is a quantified level of data because Toge discloses that Fp is monitored with respect to threshold values (id., [0051]) and because Fp is a function of Ft, Fa, and Fb, which are quantitative values. Toge discloses that tidal volume Fp is severity data because Toge discloses that tidal volume is indicative of whether the patient’s breathing warrants “emergency measures” (id., [0039]) and whether to “send an alert” in “an emergency where the patient’s breathing has drastically weakened” (id., [0055]). . . . . Because Toge discloses determining tidal volume (determine a quantified level of severity data) based on Ft, Fa, and Fb (id., [0035]), which corresponds to the subject’s condition (subject’s sleep apnea symptoms) while using the device (during the therapy) (id., [0036], [0037]), Toge discloses determin[ing] a quantified level of severity data based on the subject’s sleep apnea symptoms during the therapy. Ex. 1005 (Chatterjee Decl.) ¶¶ 122–125. Patent Owner’s attempt to dismiss tidal volume as a mere “breathing metric” is unavailing. First, Petitioner correctly “notes that in the paragraph PO cites to in Dr. Schwartz’s declaration, he indicates that breathing metrics are a level of severity data.” Pet. Reply 8 (citing Ex. 2026 ¶ 46 (“standard sleep disordered breathing metrics” [ ] were well validated indicators of the type and severity of sleep disordered breathing”)). Second, Dr. Kirkness explains that tidal volume represents the level of airway obstruction, e.g., apnea “is the most severe form of reduction in airflow [and] the absence of airflow results in quantified tidal volume of zero milliliters per breath.” Ex. 1003 (Kirkness Decl.) ¶¶ 157, 159; see also PO Resp. 10–11 (Patent Owner recognizing that an apnea is defined as absence of tidal volume for at least 10 seconds). The calculated tidal volume thus indicates severity because it is used to adjust the PAP system, e.g., in the case of decreasing tidal volume, a medical professional can change the airflow settings “to counter/treat the more severe level of airway obstruction observed from the decreasing tidal volume.” Ex. 1003 (Kirkness Decl.) ¶ 158; Pet. 15–16; Ex. 1044 (Toge) ¶ 39.” slip op. at 26

  Patent outcomesUS 11,857,333 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,857,333
• Resmed Corp. v. Cleveland Medical Devices, Inc.No claims unpatentable
  PTAB · Jun 29, 2026 · IPR2025-00247 · APJ Cynthia M Hardman · IPR · Final written decision

  Claims 1–19 were not shown unpatentable under any of six obviousness grounds because Truitt did not teach or suggest the claimed severity calculation and index, and the Mumford combinations lacked the required sensor disclosures.

  RulingsFinal written decision

  • PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner

    “Patent Owner filed an authorized Motion to Terminate, alleging that Petitioner failed to name its corporate parent, Resmed Inc., as a real party in interest. Paper 29. Petitioner filed an opposition. Paper 31. Patent Owner filed a reply. Paper 32. We denied the Motion to Terminate. Paper 40.” slip op. at 2

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

    “disorder symptoms” require a “quantitative” calculation or use of an algorithm, we also disagree. See PO Resp. 14–16. First, nothing in the language of the claims themselves describes or requires a “quantitative” calculation or an algorithm. See generally Ex. 1001, 23:6–26:59. To be sure, the ’029 patent discloses embodiments that use known algorithms to “quantify the level of severity of the subject’s sleeping disorder or symptoms.” See, e.g., id. at 20:16–19. But the Specification does not require an algorithm. The Specification also indicates that quantification is merely “preferable” (i.e., not required), and is merely one embodiment. See, e.g., id. at 19:8–12 (“The signals from the one or more sensors used in various embodiments of the present invention are preferably analyzed using a processor and software that can quantitatively estimate or determine the severity of the subject’s sleeping disorder or symptoms.”) (emphasis added), 4:51–59 (“Finally, in still another embodiment, the present invention includes a sleeping disorder treatment system comprising a device for diagnosing and creating a quantitative output of a level of severity of a subject’s sleeping disorder or symptoms . . . .”) (emphasis added); see also Reply 5–6 (citing Ex. 1001, 4:3–59 and 19:8–12 and stating that the ’029 patent lists “numerous embodiments where only one of seven include a quantitative assessment”). Elsewhere, the Specification more generally states that signals from sensors are “analyzed to determine the level of severity of the symptoms,” without specifying that such analysis must be “quantitative” or performed by an algorithm. See Ex. 1001, 3:41–44. In view of these disclosures, Patent Owner does not persuade us to adopt its narrowing claim construction. Indeed, our reviewing court has “repeatedly warned against confining the claims” to specific embodiments disclosed in the Specification. Phillips, 415 F.3d at 1323. Patent Owner’s reliance on a prior Board decision in PGR2024- 00012, which related to the parent of the ’029 patent, is unavailing. See PO Resp. 15–16. We agree with Petitioner that in the cited case, “[t]he Board made no findings about the meaning of the term calculating ‘the data of a severity of the sleep disorder symptoms of the subject’ for claim construction.” Reply 8. Indeed, neither party offered any claim construction, and the Board determined that no claim construction was necessary for purposes of that decision. See ResMed Corp., PGR2024- 00012, Paper 7 at 8. The page of the decision Patent Owner cites addresses written description support in the specification for the claims challenged in that PGR, not claim construction. See id. at 16. In any event, the cited decision is a decision on institution. The Board’s statements there are, by nature, preliminary findings and conclusions based on a preliminary record, and are not binding here. For at least the above reasons, Patent Owner does not persuade us to adopt its narrowing claim construction and we find that the term “data of a severity” does not need construction because the words of the term are clear on their face.” slip op. at 31

  • Strike new argumentNew argument disregardedDecided for patent owner

    “skilled artisan would have incorporated only portions of Mumford’s algorithm into Truitt’s PAP (i.e., only those portions related to “the detection of sleep disordered events” and not the portions of the algorithm related to “determin[ing] sleep stage”) comes too late because this argument was not in the Petition. See, e.g., Wasica Fin. GmbH v. Cont’l Auto. Sys., Inc., 853 F.3d 1272, 1286–87 (Fed. Cir. 2017) (rejecting petitioner’s “attempts to cure the petition’s deficiencies in its subsequent briefing to the Board”). The Petition does not discuss modifying Mumford’s sleep efficacy algorithm before incorporating it into Truitt’s PAP device or incorporating only certain features of the algorithm. Indeed, the Petition and Dr. Kirkness rely on Mumford’s ability to detect sleep arousals when mapping Mumford to the claimed “data of a severity” and “index.” See Pet. 69–70; Ex. 1003 (Kirkness Decl.) ¶¶ 323–325. Mumford discloses that the mask electrodes detect arousals. See Ex. 1009 (Mumford) 2:4–10, 11:39–48. The same lack of disclosure plagues Petitioner’s belated Reply argument that Truitt’s ports 74 and 76 can incorporate electric sensing elements that would have functioned similar to Mumford’s electrodes. See Reply 22. The Petition did not mention ports 74 and 76 or otherwise suggest that a skilled artisan would have added functionality similar to Mumford’s electrodes to Truitt’s PAP, and we find that it is too late on Reply for Petitioner to posit this modification.” slip op. at 40

  • Expert testimonyPetitioner expert creditedPatent owner expert creditedMixed

    “significant than the intrinsic record in determining ‘the legally operative meaning of claim language.’” Phillips v. AWH Corp., 415 F.3d 1303, 1317 (Fed. Cir. 2005). This is especially applicable to Dr. Jafari’s opinions. His declaration was not prepared for this proceeding and thus Dr. Jafari was not subject to cross examination in this proceeding. See Reply 6 n.3. Moreover, Dr. Jafari was not opining on claim construction; rather, he was addressing the alleged indefiniteness. See Ex. 2020 (Jafari Decl.) 12 (heading addressing definiteness), ¶¶ 41–42, 46. Additionally, paragraphs 41–42 of Dr. Jafari’s declaration discuss claim terms phrases in a different patent (US 11,375,921), which explicitly include the terms “quantified” and “quantitative.” See Reply 6–7; Ex. 2020 (Jafari Decl.) ¶ 34. For at least these reasons, Patent Owner has not persuaded us that Dr. Jafari’s testimony is applicable here. Further, regarding the portion of Patent Owner’s proposed construction reciting “the degree of deviation from the baseline characteristics of a patient without sleep disorder symptoms,” Dr. Borkholder does not do his own analysis, but instead simply states that he “agree[s] with the litigation claim construction opinions of Dr. Jafari.” Ex. 2019 (Borkholder Decl.) ¶ 53. This is insufficient, and thus we do not credit Dr. Borkholder’s testimony regarding claim construction. We instead credit Dr. Kirkness’s statement that “[s]everity data is frequently calculated as the deviation from baseline characteristics of the patient himself, not a generic person ‘without sleep disorder symptoms.’” Ex. 1071 (Kirkness Reply Decl.) ¶ 13; Reply 9. As Dr. Kirkness explains, and Patent Owner does not dispute (see generally Sur-reply), “[t]he ‘baseline characteristics of a [generic] patient without sleep disorder symptoms’ would be irrelevant to any particular patient with their own unique breathing patterns and sleep disorder symptoms.” Ex. 1071 (Kirkness Reply Decl.) ¶ 13 (second alteration in original). For at least these reasons, we reject Patent Owner’s proposed claim construction.” slip op. at 30

  Patent outcomesUS 11,872,029 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,872,029
• Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentable
  PTAB · Jun 24, 2026 · PGR2025-00009 · APJ Susan L C Mitchell · PGR · Final written decision

  Claims 1, 2, 6–14, and 16–29 are unpatentable based on written description, enablement, and obviousness grounds.

  RulingsFinal written decision

  • Director reviewDirector review, deniedDenied

    “Following institution, Patent Owner filed a Director Review Request (Paper 33), and Petitioner filed an Authorized Response (Paper 37), and the then-Acting Director issued a denial of the Director Review Request. Paper 40.” slip op. at 3

  • Additional discoveryAdditional discovery, deniedDenied

    “(Paper 46, “PO Resp.”), Petitioner filed a Reply to Patent Owner’s Response (Paper 71, “Pet. Reply”), and Patent Owner filed a Sur-reply (Paper 84, “PO Sur-reply”). Patent Owner filed a motion for additional discovery (Paper 62), Petitioner opposed the Motion for Discovery (Paper 63), and the Board denied the Motion for Discovery (Paper 77).” slip op. at 3

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 8

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

    “description itself. To the extent the experts disagree on this point, we credit the testimony of Petitioner’s experts over that of Patent Owner’s. For these reasons, we find that a preponderance of the evidence of record better supports a finding that in the 2011–2012 timeframe, it would have been unpredictable to identify which multiple mutants retained hyaluronidase activity, even with the single substitution data provided by the ’035 patent.” slip op. at 53

  Patent outcomesUS 12,123,035 unpatentable
  § 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 12,123,035
• Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentable
  PTAB · Jun 8, 2026 · PGR2025-00004 · APJ Susan L C Mitchell · PGR · Final written decision

  Claims 1–4, 7–19, and 22 are unpatentable under § 112(a) for lack of written description and enablement, and under § 103 as obvious.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 8

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

    “1. Petitioner’s Position Petitioner asserts that the “terms used in the claims are either” slip op. at 12

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

    “7. Analysis We find the preponderance of the evidence supports a finding that the” slip op. at 59

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

    “6. Analysis Petitioner has the burden to identify how the specification allegedly” slip op. at 70

  Patent outcomesUS 12,018,298 unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 12,018,298
• Resmed Corp. v. Cleveland Medical Devices, Inc.No claims unpatentable
  PTAB · Jun 5, 2026 · IPR2025-00160 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 1–5, 7, 8, 10–13, 15–18, and 20–31 were not shown unpatentable because the proposed Toge-Kumar combination did not establish the claimed remote internet site hosted on a server.

  RulingsFinal written decision

  • PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner

    “Patent Owner filed a Response. Paper 23 (“PO Resp.”). Petitioner filed a Reply. Paper 27 (“Reply”). Patent Owner filed a Sur-reply. Paper 35 (“Sur-reply”). Additionally, during trial, Patent Owner filed an authorized Motion to Terminate, alleging that Petitioner failed to name a real party in interest (namely, Petitioner’s corporate parent, Resmed Inc.). Paper 37. Petitioner filed an opposition. Paper 38. Patent Owner filed a reply. Paper 39. We denied the Motion to Terminate. Paper 44.” slip op. at 2

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

    “We determine that no express construction of any claim term is necessary to resolve the dispute between the parties. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). To the extent further discussion of the meaning of any claim term is necessary to our decision, we provide that discussion below in our analysis of the asserted grounds of unpatentability. C. Level of Ordinary Skill in the Art” slip op. at 11

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We adopt Petitioner’s proposed level of ordinary skill in the art because it appears to be consistent with the cited prior art and is undisputed on this record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level). D. Summary of the Asserted Prior Art” slip op. at 12

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

    “summarized above, we determine that a person of ordinary skill in the art would not have implemented Toge’s physician-side computer as a web server using a “localhost” architecture as proposed by Petitioner because such a configuration cannot communicate with external devices over the public internet, a deficiency that directly contradicts Petitioner’s stated motivations for the combination of permitting broad data access. Petitioner’s expert, Dr. Chatterjee, expressly acknowledged in his Reply Declaration that when a client and server reside on the same machine, the communications between them do not traverse the internet. Ex. 1069 ¶ 8. Specifically, Dr. Chatterjee cited the Microsoft Computer Dictionary’s definition of “localhost” as “[t]he name that is used to represent the same computer on which a TCP/IP message originates,” noting that “[a]n IP packet sent to localhost has the IP address 127.0.0.1 and does not actually go out to the Internet.” Id. (citing Ex. 1070, 316). Accordingly, Petitioner’s proposed configuration of placing both the client and web server on Toge’s physician-side computer would create a closed loop of communication that does not reach the broader network. Id. As noted by Patent Owner, “[i]f ‘the physician-side computer and the web server are on one machine,’ the local web server would not communicate with other devices via the Internet.” Sur-Reply, 3–4 (comparing Ex. 1069 ¶ 19 with id. at ¶ 8). Thus, the consequence of Petitioner’s proposed Toge-Kumar configuration is that other devices in the system, such as the PAP device that generates the treatment data and any remote client devices that might need to access that data, would be unable to send data to or retrieve data from the localhost web server. Patent Owner persuasively argues, supported by evidence of record, that under Petitioner’s proposed configuration, “the PAP device could not send data thereto nor could other clients receive data therefrom, as only the local client browser can exchange data.” Id. (citing Ex. 1069 ¶ 8); see Ex. 2003, 4 (one-tier architecture “is not suitable for a web application” because “it can only access data available in a single computer or server” and therefore “is not suitable for a web application.”); Ex. 2022, 3 (Unlike more advanced multi-tier systems, a one-tier architecture “cannot transmit information from one client machine to another.”); Ex. 2020, 4 (While “the client process and server process can be on the same computer,” this architecture “is rarely used today” precisely because it cannot “take advantage of the distributed computing environment.”).” slip op. at 29

  Patent outcomesUS 11,786,680 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,786,680
• Resmed Corp. v. Cleveland Medical Devices, Inc.No claims unpatentable
  PTAB · Jun 4, 2026 · IPR2025-00158 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 1–20 were not shown unpatentable because Orbach did not disclose a single computer or processor performing all claimed remote analysis, output, and display functions.

  RulingsFinal written decision

  • BurdenNot shown unpatentable

    “After considering all of the arguments and evidence presented on the full trial record, we determine that Petitioner has not demonstrated by a preponderance of the evidence that claims 1–6, 8–17, 19, and 20 are unpatentable as obvious over the combination of Ciulla and Orbach. We find that the deficiencies in Petitioner’s arguments regarding claim limitations [1.d], [1.f], and [1.g] are dispositive and we address the parties’ arguments concerning those limitations below.” slip op. at 24

  • Skill levelSkill level petitioner adoptedOther

    “Pet. 8. Patent Owner agrees to apply Petitioner’s proposed definition of POSITA. PO Resp. 4. We adopt Petitioner’s proposed definition of a POSITA because the proposed level of ordinary skill in the art appears to be consistent with the cited prior art and is undisputed on this record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level).” slip op. at 11

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

    “the Board need not construe any terms. Pet. 9. Patent Owner agrees. PO Resp. 4. We determine that no express construction of any claim term is necessary to resolve the dispute between the parties. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). Nevertheless, in our analysis of the asserted grounds of unpatentability below, we discuss the scope of certain claim terms, e.g., “the computer” and “the processor.” C. Level of Ordinary Skill in the Art” slip op. at 11

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

    “Accordingly, to show obviousness, Petitioner must show in Orbach that either (a) remote server 140’s output to viewing station 150 constitutes “display” within the meaning of the claim, or (b) viewing station 150 receives data “over cell towers” notwithstanding the intervening server. We determine that Petitioner has failed to do so on this record. Our analysis follows.” slip op. at 33

  Patent outcomesUS 11,690,512 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,690,512
• Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentable
  PTAB · May 18, 2026 · PGR2025-00006 · APJ Cynthia M Hardman · PGR · Final written decision

  Claims 1–4 and 8–13 are unpatentable under §112(a) for lack of written description and enablement, and under §103 as obvious over the ’429 patent and Chao.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the understanding of a person of ordinary skill in the art (sometimes referred to 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 6911–20 (2007) (Ex. 1006). 5 Patent Owner withdrew the Declaration of Dr. Triggs-Raine. PO Resp. 10 n.6. herein as “POSA”) as of the effective filing date of the challenged claims. Petitioner contends that one of ordinary skill in the art would have had an undergraduate degree, a Ph.D., and post-doctoral experience in scientific fields relevant to 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.” slip op. at 7

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

    “5. Evidence and Analysis “The construction of claims is simply a way of elaborating the normally terse claim language in order to understand and explain, but not to change, the scope of the claims.” Embrex, Inc. v. Serv. Eng’g Corp., 216 F.3d 1343, 1347 (Fed. Cir. 2000). We first turn to the intrinsic evidence because “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.” Phillips v. AWH Corp., 415 F.3d 1303, 1314 (Fed. Cir. 2005) (en banc). “[T]he specification may reveal a special definition given to a claim term by the patentee that differs from the meaning it would otherwise possess. In such cases, the inventor’s lexicography governs.” Id. at 1316. [T]he definition in the patent documents controls the claim interpretation. . . . Any other rule would be unfair to competitors who must be able to rely on the patent documents themselves, without consideration of expert opinion that then does not even exist, in ascertaining the scope of a patentee’s right to exclude. Southwall Tech., Inc. v. Cardinal IG Co., 54 F.3d 1570, 1578 (Fed. Cir. 1995). a) Intrinsic evidence Our analysis begins with the claims and Specification of the ’262 patent. Claim 1 recites a “modified PH20 polypeptide” that also requires the polypeptide sequence is 95% identical to one of the 35 recited SEQ ID NOs and with at least one of seven amino acids at position 317 of the reference sequence. The ’262 patent states “PH20 refers to a type of hyaluronidase that occurs in sperm and is neutral-active.”7 Ex. 1001, 45:45– 46; cf. id. at 68:33–37. The ’262 patent further explains that “[r]eference to PH20 includes precursor PH20 polypeptides and mature PH20 polypeptides (such as those in which a signal sequence has been removed), truncated forms thereof that have activity, and includes allelic variants and species variants, variants encoded by splice variants, and other variants.” Id. at 45:62–67. The ’262 patent states that “PH20 polypeptides also include those that contain chemical or posttranslational modifications and those that do not contain chemical or posttranslational modifications.” Id. at 46:4–7.” slip op. at 15

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

    “four species tested, and particularly in a primate model that is physiologically more similar to humans, shows that a POSA would not have understood even unmodified PH20 polypeptides to provide a contraceptive effect in humans and most other species. The data Patent Owner relies upon at most shows an immunocontraceptive effect for unmodified PH20 polypeptides limited to guinea pigs. It does not evidence that a POSA would have understood that the recited modified polypeptides would provide such an effect or otherwise be useful in a contraceptive vaccine. Accordingly, even if the term “modified PH20 polypeptides” were interpreted to include inactive polypeptides that can serve as antigens to provide a contraceptive effect, the preponderance of the evidence does not show that a POSA would have understood the inventors to be in possession of the full scope of the recited polypeptides capable of such use. 7. Analysis We find the preponderance of the evidence supports a finding that the claims fail to comply with the written description requirement. “Every patent must describe an invention. It is part of the quid pro quo of a patent.” Ariad, 598 F.3d at 1345. In determining compliance with the written description requirement for nucleic acid genus claims, the Federal Circuit has identified two extremes. In Capon, claims relying on known nucleotide sequences with known functions were found to satisfy the written description requirement. Capon v. Eshhar, 418 F.3d 1349, 1358 (Fed. Cir. 2005). At the other end, Juno found that for broad claims to a nucleic acid encoding a chimeric T cell receptor with a functional requirement to bind a target, “the written description ‘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.’” Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337 (Fed. Cir. 2021) (quoting Ariad, 598 F.3d at 1349). As explained above, claim 1 requires modified PH20 polypeptides with some hyaluronidase activity. See supra Section II.B. Based on this claim interpretation, we find the evidence in this case closer to Juno than Capon, and that the ’262 patent does not disclose sufficient structural features in the PH20 sequences associated with hyaluronidase or” slip op. at 57

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

    “6. Analysis Petitioner has the burden to identify how the specification allegedly fails to enable the claims. We address the Wands factors and the parties’ respective arguments and evidence. a) Breadth of Claims and Nature of the Invention Dr. Park states, regarding the breadth of claim 1, that he “calculated the number of distinct polypeptides that exist that meet the specified criteria.” Ex. 1004 ¶ 173. Dr. Park’s table is reproduced below: Dr. Park’s table shows that the “number of distinct peptides is extremely large by all accounts, ranging from 1049 to 1066.” Id. Dr. Hecht agrees, stating the “sequence identity language causes the claims to encompass an immense number of distinct PH20 polypeptides.” Ex. 1003 ¶ 120. To illustrate how large a number like 1066 is, Dr. Hecht states that an “aggregate weight of the smallest set containing one molecule of each of the PH20 mutants would be . . . = 1.37 x 1027 kg. The weight of the Earth is ‘only’ ~ 5.97 x 1024 kg.” Id. ¶ 123. That is, Dr. Hecht states that a complete set of one single molecule of protein that comprises all possible mutations in PH20 as recited in claim 1 would weigh about one thousand times more than the entire mass of planet Earth. See id. In deposition, Dr. Hecht stated “my sense was that the ’262 patent lists a minuscule and highly biased sample of what would be within that fence, in the sense that it only lists single amino acid substitutions while at the same time it’s attempting to claim things that have 20 or more substitutions.” Ex. 2076, 203:6‒12. When asked if a sequence “gives you enough information to tell whether that amino acid sequence is 95 percent identical to SEQ ID NO. 3”, Dr. Hecht answered “Yes, but that’s all it tells you. It doesn’t tell you anything about active, precipitated, aggregated, folded. It doesn’t tell you anything.” Id. at 204:11‒19.” slip op. at 70

  Patent outcomesUS 12,152,262 unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 12,152,262
• Resmed Corp. v. Cleveland Medical Devices, Inc.No claims unpatentable
  PTAB · May 18, 2026 · IPR2025-00159 · APJ Cynthia M Hardman · IPR · Final written decision

  Claims 1, 2, 4, 5, 7–9, 11–14, and 16 were not shown unpatentable under either § 103 ground because Petitioner did not establish the proposed remote internet site modification.

  RulingsFinal written decision

  • PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for patent ownerDecided for patent owner

    “Patent Owner filed an authorized Motion to Terminate, alleging that Petitioner failed to name a real party in interest (namely, Petitioner’s corporate parent, Resmed Inc.). Paper 37. Petitioner filed an opposition. Paper 38. Patent Owner filed a reply. Paper 39. We denied the Motion to Terminate. Paper 44.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “understanding of a person of ordinary skill in the art at the time the invention was made.8 See Graham, 383 U.S. at 17–18. The parties agree that a person of ordinary skill in the art (sometimes referred to herein as a POSITA) would have had: at least a bachelor’s degree in mechanical engineering, electrical engineering, computer science, biomedical engineering, or a similar technical field, with at least two years of relevant product design experience working with diagnostic sensor systems and network data systems, such as networked PAP machines. Additional experience could substitute for less education, and additional education could likewise substitute for less experience. Pet. 12–13 (citing Ex. 1003 (Kirkness Decl.) ¶¶ 44–46); PO Resp. 7–8. Because the proposed level of ordinary skill in the art is consistent with the cited prior art and is undisputed on this record, we adopt it for purposes of this Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level).” slip op. at 11

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

    “We find it unnecessary to construe any claim term to resolve the issues in this case. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (noting that “we 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

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

    “its burden of explaining why a person of ordinary skill in the art would have implemented a remote internet site in Toge’s system in the specific fashion Petitioner asserts (i.e., using the physician-side computer as a web server). As Patent Owner aptly states, the operative question is not merely whether a person of ordinary skill in the art would have modified Toge’s system to include a remote internet site, but whether the artisan would have modified Toge’s system to include a remote internet site “on a physician’s client computer” in accordance with the specific implementation argued by Petitioner. Sur-reply 2. On this critical question, Petitioner’s arguments are thin. Petitioner’s declarant Dr. Kirkness states that a person of ordinary skill in the art “would have understood that one common way to access data transmitted over the internet, like the data from Toge’s wireless PAP device, is via a remote internet site.” Ex. 1003 ¶ 214. This assertion is reasonable. Indeed, prior art of record, such as Kumar, illustrates use of a central server that hosts a browser-based engine that can be accessed through web pages. See, e.g., Ex. 1008 (Kumar) Fig. 1A, ¶¶ 67, 72, 79, Pet. 10. Petitioner, however, elected to argue a specific implementation, namely that the skilled artisan would have modified Toge’s physician-side computer to operate as a web server. See, e.g., Pet. 15; Ex. 1005 (Chatterjee Decl.) ¶ 146; Reply 4. We find that this implementation is unsupported on this record. Petitioner has not pointed us to any disclosure in Toge, Burton, or Kumar (or any other prior art reference of record) that teaches or suggests “that a doctor’s computer should act a web server hosting sensitive patient data.” PO Resp. 9 (emphasis added). And critically, the Petition is silent as to why a person of ordinary skill in the art would have selected this implementation in particular. See, e.g., Pet. 49.” slip op. at 25

  Patent outcomesUS 11,375,921 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,375,921
• Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentable
  PTAB · May 12, 2026 · PGR2025-00003 · APJ Jeffrey N Fredman · PGR · Final written decision

  Claims 1–4 and 8–21 are unpatentable for lack of written description and enablement; obviousness over the ’429 patent and Chao was not shown.

  RulingsFinal written decision

  • Skill levelSkill level board ownOther

    “VII. LEVEL OF ORDINARY SKILL IN THE ART We consider the grounds of unpatentability in view of the” slip op. at 7

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

    “term “modified PH20 polypeptide” in the ’600 patent supports the understanding that some type of activity is required for a polypeptide to be a “modified PH20 polypeptide”, and that the enzymatic activity of hyaluronidase is the most frequently identified activity recited in the definitions section of the ’600 patent. Id. at 48:38–53, 50:9‒17, 51:15‒18, 52:41–47, 55:9–23, 63:37–44, 64:14–19. In contrast, the discussion regarding the potential use of “modified PH20 polypeptides that are inactive” as antigens in contraception vaccines appears only in a non-definitional section of the ’600 patent. Id. at 75:56–58, 72:60–62. Accordingly, it does not modify the definition’s explicit requirement that the claimed “modified PH20 polypeptide” exhibit hyaluronidase activity. Id. at 48:38–53.” slip op. at 19

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

    “been able to use the data in the Specification to make reasonable predictions about the effect of multiple modifications on hyaluronidase activity, we view this testimony to at most describe a research plan (i.e., a “tool to engage in further modification”14) for finding the recited polypeptides rather than demonstrating the inventors were in possession of the full scope claimed. This is particularly so given the limits of the then-available analytical tools noted above and the fact that the structural connections and three dimensional modeling Patent Owner’s experts attempt to make (see, e.g., Ex. 2070 ¶¶ 129–213; Ex. 2068 ¶ 123) do not appear in the written description itself. To the extent the experts disagree on this point, we credit the testimony of Petitioner’s experts over that of Patent Owner’s. For these reasons, we find that a preponderance of the evidence of record better supports a finding that in the 2011–12 timeframe, it would have been unpredictable to identify which multiple mutants retained hyaluronidase activity, even with the single substitution data provided by the ’600 patent.” slip op. at 51

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

    “8. Conclusion We find that the balance of evidence supports a finding of undue” slip op. at 101

  Patent outcomesUS 11,952,600 unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 11,952,600
• Illumina, Inc. v. Molecular Loop Biosciences, Inc.No claims unpatentable
  PTAB · Apr 15, 2026 · IPR2024-01419 · APJ Susan L C Mitchell · IPR · Final written decision

  Claims 1–9 were not shown unpatentable because the asserted references failed to disclose the claimed correcting step, and Chee was not prior art to claims 1–3 and 9.

  RulingsFinal written decision

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedReference not prior artDecided for patent owner

    “We have considered both parties’ arguments and evidence and determine that Patent Owner has presented sufficient evidence of reasonable the invention to practice every day during the critical period in order to demonstrate reasonable diligence. See Perfect Surgical Techniques, Inc. v. Olympus America, Inc., 841 F.3d 1004, 1009 (Fed. Cir. 2016). “[D]iligence need not be perfectly continuous—only reasonably continuous.” Arctic Cat Inc. v. GEP Power Prods., Inc., 919 F.3d 1320, 1331 (2019). The key question is whether, “in light of the evidence as a whole, the invention was not abandoned or unreasonably delayed.” Id. (internal quotations omitted). Applying this standard, we determine that Patent Owner sufficiently demonstrates reasonably continuous diligence throughout the critical period.” slip op. at 32

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

    “introduced during said workflow by collapsing target:differentiator tag combinations observed more than once into a single count.” Ex. 1001, 131:46–48 (emphasis added). The “determining step” of claim 2 recites “determining a consensus base call for the target nucleic acid molecule sequences,” but performs “collapsing all sequence reads comprising a same differentiator tag into a single read,” before the “determining step.” Id. at 131:49–53. Patent Owner proposes an interpretation of these “collapsing” and “determining” steps recited in claims 1 and 2 and asserts that they should be construed as distinct steps performed in a particular order in which the “collapsing step” is performed before the “determining step.” PO Resp. 42–45. We agree. First, Patent Owner asserts a person of ordinary skill in the art would have understood that the “collapsing step” of claim 1 is distinct from, and must occur before, the “determining step” of claim 2 based on the plain language of claims 1 and 2. PO Resp. 42–43. Patent Owner argues that the “collapsing step” and the “determining step” are distinct steps because claims 1 and 2 use different terms to describe these distinct steps that are performed sequentially according to the claim language. Id. (citing Ex. 1001, 131:47–54; Ex. 2023 ¶ 133; Ex. 2024, 57:11–58:22). More specifically, Patent Owner explains that claim 1 recites a “collapsing step,” followed by claim 2, which depends from claim 1 and refers to “collapsing” before “determining a consensus base call” such that “claim 2 describes determining a consensus base call from collapsed reads, not performing ‘collapsing’ by determining a consensus base call.” Id. at 42 (citing Ex. 1001, 131:47–54). collapsing corrects for skewing, an issue related to over- or under-amplification, which is a separate and distinct problem from the sequence errors that a consensus base call is designed to address.” Id. at 43 (citing Ex. 1001, 27:47–50, 32:29–34). Patent Owner contends further that “‘[c]ollapsing’ is a different step, performed separately from determining any consensus base call, to provide even greater accuracy when subsequently determining a consensus base call” such that “if one were to collapse by determining the consensus base call, errors from amplification bias could still be represented in the consensus base call generated.” Id. at 43–44 (emphasis omitted, citing Ex. 2023 ¶¶ 134–37). Second, Patent Owner argues a person of ordinary skill in the art would have understood that the “collapsing step” of claim 1 is distinct from the “determining step” based on the specification of the ’730 patent. PO Resp. 43–45. For example, Patent Owner explains that the specification states that “[f]or any target:differentiator tag combination observed more than once, all such reads are ‘collapsed’ into a single read before consensus basecalls are determined. This will cancel the effect of bias on consensus basecall accuracy.” Id. at 43 (emphasis omitted) (quoting Ex. 1001, 72:63– 73:5) (citing Ex. 2023 ¶¶ 133, 138–142).” slip op. at 11

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable

    “We have considered both parties’ arguments and evidence and agree with Patent Owner’s position. As discussed above, we agree with Patent Owner that the “collapsing step” recited in claim 1 and the “determining step” recited in claim 2 are two different steps required by the challenged claims such that “collapsing” does not mean determining a consensus base call or sequence, and must occur before any determining step. As a result, we determine Chee’s step of determining a consensus sequence does not disclose the “collapsing step” recited in claim 1 that requires collapsing “target:differentiator tag combinations.” We are also unpersuaded by Petitioner’s reliance on Chee’s process of correcting for amplification bias as disclosing the claimed collapsing step. As recognized by Patent Owner, the claim language of the “collapsing step” requires “collapsing target:differentiator tag combinations,” rather than collapsing only differentiator tags. In view of this requirement, Chee does not disclose the “collapsing step” because Chee teaches quantifying the starting nucleic acid molecules using their unique identifiers, rather than target:differentiator tag combinations. As Petitioner admits, “Chee’s technique for correcting amplification bias corrects quantitative errors without correcting sequencing errors” (Reply 15), whereas claim 1’s “collapsing step” corrects both quantitative errors and sequencing errors by using target:differentiator tag combinations. See Ex. 1001, 131:47–49 target:differentiator tag combinations).” slip op. at 41

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

    “Given this claim interpretation requiring collapsing target:differentiator tag combinations, it is undisputed that McCloskey, who uses unique barcodes alone, does not teach this limitation. Petitioner does not rely on Bignell as teaching this collapsing step. Accordingly, we conclude Petitioner has not shown that the combination of Bignell and McCloskey teaches the “collapsing step” recited in claim 1. Because claims 4 through 6 depend from claim 1, they also require the “collapsing step” of claim 1 that is not taught by the combination of Bignell and McCloskey.” slip op. at 54

  Patent outcomesUS 11,840,730 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Graham
  Patents in suitUS 11,840,730

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.