• Clearcorrect Operating, LLC v. Align Technology Inc.No claims unpatentable
  PTAB · Sep 29, 2026 · IPR2025-00817 · APJ Kevin F Turner · IPR · Final written decision

  Claims 1–20 were not shown unpatentable because the cited combinations did not teach or suggest partial insertion of new scan data into an existing 3D model.

  RulingsFinal written decision

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

    “that Boerjes alone teaches or suggests limitation 1(h) by a preponderance of the evidence. Although the Petition is persuasive that Boerjes allows a user to “identify areas that need replacing, such as ‘a margin line’ to be removed, ‘areas of poor margin preparation,’ and ‘holes or areas of incomplete scan[s],’” and that the user can identify regions of a prepared tooth surface requiring additional preparations and “supplemental scanning” (Pet. 32 (citing Ex. 1004 ¶¶ 189, 193, 196)), Boerjes is silent with respect to replacing at least a portion of the removed surface portion of the model using the received second scan data of the patient’s teeth, per claim 1. Boerjes certainly contemplates the re-scanning of the dentition, but does not assert partial insertion of new data into an existing 3D model. We acknowledge that Petitioner has argued (Pet. 43–44) that Boerjes’ Figure 4 and paragraph 144 of Boerjes teach partial replacement, but we are persuaded that those disclosures suggest total replacement and not partial replacement. The reference to “supplemented or replaced with new scan data” (Ex. 1004 ¶ 199) does not necessarily teach or suggest partial scanning, as Petitioner has argued. Additionally, Petitioner has argued (Pet. “combining historical three-dimensional data” (quoting Ex. 1004 ¶¶ 139, 144, 163), would have suggested to ordinarily skilled artisans that “Boerjes would be used to replace at least a portion of the model with the new scan data. Id. at 45 (citing Ex. 1003 ¶ 112). These disclosures are, however, applicable to scans that create complete replacement as well as partial replacement. We remain persuaded that Boerjes does not teach partial scans used to obtain partial replacement. Even under the “comprising” language of claim 1, for example, the complete replacement of a 3D model cannot teach or suggest “replacing at least a portion of the removed surface portion” without repudiating the language of the claim by making a portion be the entire model. Even if, as Petitioner asserts, “removing portions of a virtual model has been a well-known and routine technique in 3D modeling,” and the “process of replacing a user-identified portion would have been well within the skills of a POSITA” (Pet. 35), the disclosure of Boerjes does not teach or suggest such processes. Although Boerjes allows for the possibility that portions of a model can be identified as needing replacement or supplementation, it does not disclose the partial replacement required by the instant, independent claims. Boerjes’s actual disclosure details that supplemental scanning is used to compensate for an inadequate scan, but such supplemental scanning is not disclosed to be used to stitch together before-and-after models that have undergone an intervening physical change.” slip op. at 15

  Patent outcomesUS 10,791,936 not shown unpatentable
  § 103 obviousnesscites KSR
  Patents in suitUS 10,791,936
• Samsung Electronics Co., Ltd. / Samsung Electronics America, Inc. v. Ouraring, Inc.No claims unpatentable
  PTAB · Jul 10, 2026 · IPR2025-00147 · APJ Linda E Horner · IPR · Final written decision

  The Board found claims 1–6 and 8–20 not shown unpatentable under three obviousness grounds, principally because the proposed combinations did not establish a feasible curved battery or transparent potting encapsulating the components.

  RulingsFinal written decision

  • Skill levelSkill level board ownOther

    “at least a four-year degree in electrical engineering, mechanical engineering, biomedical engineering, optical engineering, or related field of study, or equivalent experience, and at least two years’ experience in academia or industry studying or developing physiological monitoring devices such as non-invasive biosensors. Pet. 8 (citing Ex. 1002 ¶ 29). Petitioner also contends that a person of ordinary skill would have been “familiar with, e.g., sensor system design, including inertial and other motion sensor system design, and signal processing” and that “[a] higher level of education or skill might make up for less experience, and vice versa.” Id. Patent Owner agrees with Petitioner’s proposed definition of a person of ordinary skill in the art. Resp. 25. We adopt this uncontested definition of the level of ordinary skill in the art. This definition is supported by the record and consistent with the disclosure in the ’124 patent and the references cited in the Petition.” slip op. at 10

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

    “We need not reach the issue of whether the preamble is limiting for purposes of determining patentability of the challenged claims. Even were we to agree with Patent Owner that the preamble is limiting and the claims are limited to a finger-worn ring wearable computer device, Petitioner has relied on Schröder in each ground to disclose a “wearable computing device configured to be worn around a finger of a wearer.” Pet. 22 (Ground 1), 45 (Ground 2, relying on Yuen for adding the functionality of light sources with a photodetector, temperature sensors, and varying the sampling frequency of sensor data acquisition), 56 (Ground 3). We agree with Petitioner that Schröder discloses such a device. Thus, no explicit claim construction is necessary for this decision.” slip op. at 11

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

    “We are not persuaded by Petitioner’s arguments and find that Patent Owner has the better position for several reasons. First, the record supports Patent Owner’s argument that Mestas’s batteries are much too large to fit within a ring form factor, and “would have to be reduced in size on the 6 There is no Exhibit 2022 in the record of this case. magnitude of 5-10x from its current size to fit in a ring of Schröder.” Resp. 38 (citing Dr. Anthony’s cross-examination testimony at Ex. 2021, 313:12). Second, Petitioner relies on evidence in the Reply that Petitioner failed to specifically identify in the Petition. Compare Reply 3–5 (citing Ex. 1369 ¶¶ 7–14; Ex. 1079 ¶¶ 47, 71; Ex. 2022, 138:7–143:1; Ex. 1002 ¶¶ 96, 337; Ex. 2021, 12–13, 307:7–17; Ex. 2020, 212:6–214:13; Ex. 1081, 130:18–131:14; Ex. 1010 ¶ 168), 9 (referring back to Section § II.B.2) with Pet. 25–26 (citing Ex. 1002 ¶¶ 193–99; Ex. 1010 ¶¶ 157, 163, 168, 201, Fig. 6). More specifically, while the portion of Dr. Anthony’s Declaration cited in the Petition (see Pet. 25–26 (citing Ex. 1002 ¶¶ 193–99)) mentions the Technology Background Section V of his Declaration (Ex. 1002 ¶¶ 42–147), neither Petitioner nor Dr. Anthony sufficiently explains what evidence supports his opinion that it was feasible to incorporate batteries or battery-like devices into finger-rings, or how a person of ordinary skill in the art would have miniaturized a curved battery for incorporation into Schröder’s ring. Ex. 1002 ¶ 196 (describing that rechargeable batteries powering wearable electronic devices were “well-known by 2013” and “had also undergone significant advances in terms of miniaturization and energy density [that] made it feasible to incorporate batteries or battery-like devices such as supercapacitors into smaller form factors, such as finger rings, without sacrificing functionality” such as “lithium-polymer (Li-Po) batteries and solid-state batteries.”). Moreover, some of Petitioner’s citations in the Reply appear to be incorrect as there is no Exhibit 2022 of record in this case, as noted above. These issues undermine the strength of Petitioner’s showing by making it difficult to follow its reasoning, much less identify where in the record that reasoning finds support. See DeSilva v. DiLeonardi, 181 F.3d 865, 866–67 (7th Cir. 1999) (“A brief must make all arguments accessible to the judges, rather than ask them to play archaeologist with the record.”); United States v. Dunkel, 927 F.2d 955, 956 (7th Cir. 1991) (“Judges are not like pigs, hunting for truffles buried in briefs.”). Third, even considering Petitioner’s new Reply arguments and” slip op. at 27

  • Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner

    “We credit Dr. Mercier’s testimony over Dr. Anthony’s and agree that Dr. Anthony’s testimony fails to account for the constraints of a substantially smaller form factor in Schröder’s finger-ring as compared to Mestas’s wrist device. Ex. 2018 ¶ 140. Although large curved batteries suitable for use in a wrist band or other larger wearable device, such as shown in Mestas, were known at the time of the ’124 patent, we also have evidence that prior art “finger ring wearables up to the ’124 patent had used ‘coin’ type batteries.” Resp. 40 (citing Ex. 2018 ¶ 140). We credit Dr. Mercier’s testimony that a person having ordinary skill in the art would have looked to a coin type battery for the necessary power requirements of Schröder’s device. Ex. 2018 ¶ 141. Indeed, this testimony is consistent with the other art of record that consistently shows the use of flat batteries in finger-ring devices, often stacked above and protruding from the general ring shape of the device. See, e.g., Ex. 1005 (Niwa), Figs. 22, 28; Ex. 2025 (Asada ’701 patent), Fig. 4; Ex. 1035 (Rhee), Figs. 7-1, 8-1, 8-2; Ex. 1037 (Asada article), Fig. 9; Ex. 1034 (Asada ’199 patent), Fig. 2; Ex. 1028 (Kimura patent), Fig. 24; Ex. 2018 ¶¶ 74–84. In fact, Oura’s first-generation ring design, released in 2015, used a Superbowl ring type design, with the battery and other components mounted on top of the ring. Ex. 2034; Ex. 2018 ¶ 85. We also agree with Dr. Mercier that Dr. Anthony’s testimony lacks evidence or a technical analysis of the power requirements for the various sensors he suggests including in a wearable device and the capacity of the proposed GMBPow battery. See, e.g., Ex. 1002 ¶¶ 94, 210, 214–17; Ex. 2018 ¶ 97. Moreover, Dr. Anthony does not address the issues with the batteries that are identified in the references he discusses. For example, Dr. Anthony does not address Lee’s disclosure that “direct coating of electrode slurry onto plain paper led to the occasional internal-shorting of the device due to the leakage of the electrode material through a large-sized hole in the paper.” Ex. 1019, 2415. In contrast, Dr. Mercier discusses the pitfalls the skilled artisan faced in developing finger-ring devices. See, e.g., Ex. 2018 ¶¶ 77–79 (discussing the issues Rhee’s and Asada’s large rings), 83 (identifying power requirements as a design constraint). For example, Dr. Mercier explains that “flexible or curved batteries include flexible packaging materials such as aluminum laminated films that house the electrodes and electrolyte” such that “once the battery packaging is added to a battery such as GMBPow and then placed within a housing (e.g., external housing shell and internal potting), the resulting device would have dimensions that are not suitable for a finger-worn ring.” Id. ¶ 96 (citing Ex. 2026).” slip op. at 34

  Patent outcomesUS 11,188,124 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,188,124
• 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
• 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
• 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
• Axion Biosystems, Inc. v. Agilent Technologies, Inc.No claims unpatentable
  PTAB · Feb 2, 2026 · IPR2024-01467 · APJ David Cotta · IPR · Final written decision

  Claims 1–8 and 11–15 were not shown unpatentable over Xu-752 and Jones because the proposed combination did not establish obvious millisecond time resolution.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “B. Level of Ordinary Skill in the Art Petitioner contends a person of ordinary skill in the art (“POSA”) as of May 2009 “would have had a B.S. in electrical/mechanical/biomedical engineering or biological science, or a related field, and approximately 2 years of relevant experience or equivalent study in systems and methods for bioanalysis of cells.” Pet. 14 (citing Ex. 1003 ¶¶ 23–25). Patent Owner adopts this definition for purposes of this proceeding. PO Resp. 9 (citing Ex. 2009 ¶ 19). We find Petitioner’s description of the level of ordinary skill in the art to be consistent with the level of skill reflected in the ’508 patent and in the prior art of record. Accordingly, we apply Petitioner’s definition in this decision.” slip op. at 7

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

    “As used herein, “impedance measurement at millisecond time resolution” refers to the ability to perform a series of at least two consecutive impedance measurements within milliseconds of one another for each and every well of the system where each well is associated with an electrode array for impedance measurement. In each instance the time between two consecutive impedance measurements are less than 300 milliseconds from one another. Id. at 10:8–15. There does not appear to be any dispute as to the definitional nature of the first sentence in the passage above. That is, the parties agree that millisecond time resolution should be construed to mean: “the time between two consecutive impedance measurements for each and every well being evaluated in the claimed apparatus or system.” PO Resp. 15 (proposing construction); Pet. Reply. 23 (“Axion also agrees that the term ‘millisecond time resolution’ is ‘the time between two consecutive impedance measurements for each and every well being evaluated in the claimed apparatus or system.’”). The parties also agree that we do not need to determine whether the time interval between two consecutive impedance measurements is less than 300 milliseconds, as set forth in the definition portion of the specification, or whether it can be met by some other time interval, as suggested by other portions of the specification. See e.g., Ex. 1001, 23:49–55 (explaining that “[i]n some embodiments 500 millisecond time resolution is sufficient”), 24:37–39 (similar); PO Resp. 15 (arguing that “the distinction between 300 milliseconds and 500 milliseconds is immaterial to the dispute in this IPR because Jones teaches a 1.5 second update period, thus at least three times longer than the 500 milliseconds formulation”); Pet. Reply 23–24 (section headed “[Petitioner] Agrees That, In This IPR, The 300 Versus 500 Milliseconds Distinction is Immaterial To Addressing the Unpatentability of the Challenged Claims”), see also, Pet. Reply 24–26 (asserting that the claims are indefinite because it is not clear whether they require a 300 or a 500 millisecond time interval, but arguing that “the claims’ unpatentability can be determined without resolving the 300 versus 500 milliseconds indefiniteness issue”). We agree with the parties that “millisecond time resolution” should be construed to mean: “the time between two consecutive impedance measurements for each and every well being evaluated in the claimed apparatus or system.” PO Resp. 15; Pet. Reply. 23. We further agree that resolution of this case does not require that we determine whether the period between two consecutive impedance measurements is less than 300 or less than 500 milliseconds because Petitioner has not carried its burden under either time interval.” slip op. at 7

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “Ex. 1003 ¶ 179. But Dr. Kim does not cite to any additional supporting evidence or provide any technical reasoning to support his statements. The notion that one can reduce the time between measurements by, e.g., reducing the number of frequencies measured, has intuitive appeal and appears mathematically correct. However, the absence of technical reasoning and supporting evidence diminishes the persuasiveness of Dr. Kim’s testimony that the POSA would made such modifications to reduce the time between measurements. Dr. Kim does provide some technical reasoning in connection with his discussion of eliminating all reference channels as a way to get the time resolution down to the levels required by, e.g., claim 14, which recites a millisecond time resolution of “less than 5 milliseconds.” See e.g., Ex. 1003 ¶ 172 (“A POSA seeking to study biological cell phenomena occurring on the order of a few milliseconds would have recognized that after measuring the reference network channels at the start, the reference network channels would not need measured again for some time, e.g., because temperature and other drift factors do not change appreciably on a millisecond time scale.”). However, even if we were to credit this testimony, Dr. Kim still lacks support and reasoning for the selection of the other parameters in his noreference-channel calculations. See, e.g., id. ¶ 173 (positing, but not providing technical reasoning for using, a no-reference-channel impedance system with 16 wells, a single 10kHz measurement frequency, and 16 daughter boards that measure simultaneously rather than sequentially).” slip op. at 29

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

    “Given that Jones’s only exemplified embodiment targets a 1.5 second update period, that Jones does not suggest reducing the update period, and that much of Jones’s focus is on benefits other than speed of measurement, Jones’s impedance analyzer seems an unlikely choice for a POSA seeking to take measurements having millisecond time resolution. Put another way, we find no persuasive non-hindsight reason that supports Petitioner’s assertion that the POSA would have sought to apply Jones’s impedance analyzer to Xu-752’s system in order to take measurements in millisecond time resolution.” slip op. at 22

  Patent outcomesUS 11,906,508 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,906,508
• Samsung Electronics Co., Ltd. / Samsung Electronics America, Inc. v. Ouraring, Inc.No claims unpatentable
  PTAB · Jan 30, 2026 · IPR2024-01078 · APJ Neil T Powell · IPR · Final written decision

  Claims 1–6, 11–15, and 38–43 were not shown unpatentable because Petitioner failed to establish obviousness over the asserted combinations, including the feasibility and motivation to use curved batteries in a ring.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

    “Patent Owner agrees with Petitioner’s proposed definition of a person of ordinary skill in the art. PO Resp. 22; see also Ex. 2018 ¶ 27. We adopt this uncontested definition of the level of ordinary skill in the art. This definition is supported by the record and consistent with the disclosure in the ’953 patent and the references cited in the Petition.” slip op. at 9

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

    “Petitioner expresses that it “does not believe that any term requires express construction.” Pet. 8. “Patent Owner agrees with Petitioner that no terms need to be construed.” PO Resp. 22. We agree with the parties that resolution of their dispute does not require us to construe any claim terms. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (holding that only claim terms in controversy controversy) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 9

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

    “be improper hindsight in Petitioner’s position. Petitioner and Dr. Anthony assume that a POSITA would position the battery between Schröder’s ring halves and implement Mestas’s curved battery because it “allows a larger battery to conform to a ring’s circular shape without stressing the battery or ring housing.” Pet. 60, 64–65; Ex. 1002 ¶¶ 337, 351–354. That position, however, ignores alternative designs that are at least equally supported by Schröder’s disclosure (see Ex. 1007, Fig. 3), but would not result in a ring configured as recited in the challenged claims. Petitioner attempts to downplay this concern by characterizing the modification of Schröder’s ring to include Mestas’s curved battery as an obvious “matter of choice” in design. See Reply 10–11 (citing Ex. 1079 ¶¶ 71–77). We disagree. As explained above, the record supports Patent Owner’s argument that Mestas’s batteries are much too large to fit within a ring form factor because they are “5 to 10 times” the size that would be required for a finger ring. PO Resp. 27 (quoting Ex. 2021, 313:12). Petitioner argues that it “does not propose bodily incorporating Mestas’s battery into Schröder’s ring,” which on the surface is correct. See Reply 10. But this does not help Petitioner meet its burden because its actual obviousness theory that “a POSITA would have found it trivial to implement Mestas’s teachings into a ring like Schröder’s ‘finger-ring’” is not persuasive. See Pet. 60 (citing Ex. 1002 ¶ 338). For the same reasons explained in Section II.D.1 above in our analysis of Ground 1, Dr. Mestas’s teaching of a curved battery (Ex. 1002 ¶ 338) in the much smaller form factor of Schröder’s ring is not credible. See Ex. 2021, 315:9–318:9 (acknowledging that it would have been beyond the level of ordinary skill to miniaturize Mestas’s battery, but that a POSITA could try to procure one); 321:5–10 (conceding that he did not try to ascertain whether such a battery was available in the relevant time frame). Instead, we credit Dr. Mercier’s testimony that Petitioner’s proposed modification would have presented intractable practical challenges. Ex. 2018 ¶¶ 228, 230–240 (describing various aspects of battery design that Dr. Anthony did not consider). As before, Dr. Mercier’s testimony is further supported by evidence showing a consistent pattern of flat battery use in prior art finger-ring devices. See, e.g., Ex. 1005 (Niwa), Figs. 22, 29; Ex. 2025 (Asada ’701 patent), Fig. 4; Ex. 1035 (Rhee), Figs. 7-1, 8-1, 8-2; Ex. 1037 (Asada article), Fig. 9; Ex. 1034 (Asada ’199 patent), Fig. 2; Ex. 1028 (Kimura), Fig. 24; Ex. 2018 ¶¶ 57–67. In sum, Petitioner’s showing for limitation 1[c] is deficient in multiple respects. First, Petitioner assumes that an ordinarily-skilled artisan would have been motivated to implement Mestas’s curved battery in the much smaller interior space occupied by Schröder’s inlay 12 without sufficiently considering the feasibility of that modification or alternative designs suggested by Schröder. Second, even if we accept Petitioner’s purported rationale for the combination (which we do not because we find it that it is predicated on improper hindsight), Petitioner has not shown that an ordinarily-skilled artisan would have had a reasonable expectation of successfully implementing the proposed modification.” slip op. at 46

  • Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia with nexusDecided for patent owner

    “We find that the evidence presented by Patent Owner is sufficient to establish that the Oura Ring Gen. 3 Horizon and Gen. 4 products are commercial embodiments of claim 1 of the ’953 patent and that claim 1 is coextensive in that it encompasses the entire structural apparatus of these products. See PO Resp. 82–92; Ex. 2018 ¶¶ 322–346 (comparing these products to claim 1); Ex. 2029; Ex. 2030; Ex. 2118; Ex. 2119.9 Indeed, Petitioner does not challenge any aspect of Dr. Mercier’s limitation-by-limitation analysis showing that these products practice claim 1. But more than just practicing the claimed invention, Patent Owner’s evidence supports that claim 1 recites the overall structure that provides for the particular form factor of the Oura Ring Gen. 3 Horizon and Gen. 4 products, i.e., a fingerring “wedding band” design that allows for the electronic components to be entirely contained within the ring housing with a curved external surface having no protrusions or bulges. Ex. 2018 ¶¶ 359–360; see also id. ¶¶ 322–346 (pictures depicting wedding band design of the Oura Ring Gen. 3 Horizon and Gen. 4 products); Ex. 2019 ¶¶ 47–49 (“[Patent Owner’s] decision to highlight the ring form factor indicates this feature’s importance to the marketplace success of the Oura Ring.”). We disagree with Petitioner’s assertion that the Oura Ring Application and/or Oura Membership are essential, unclaimed features such that a presumption of nexus is not appropriate. The Oura Application functions in conjunction with the Oura Ring to form a “complete solution” 9 Patent Owner and Dr. Mercier only compare these products to claim 1. Patent Owner has not demonstrated a nexus to independent claim 38. ¶¶ 20–21. The Oura Application cannot receive or display any information absent the Oura Ring’s ability to collect the information from the user. Id. Even though the Oura Application may provide additional unclaimed functionality, such as displaying activity, sleep, and readiness scores based on the data collected by the Oura ring that allow “a user to take advantage of the ring’s offerings,” this functionality is secondary to the ring’s ability to collect that data, without which, the Oura Application would serve no purpose. See Ex. 2019 ¶ 21; Ex. 2024, 93:22–95:22. As the Federal Circuit has explained, “there is rarely a perfect correspondence between the claimed invention and the product.” Fox Factory, 944 F.3d at 1374. Here, we find that on the spectrum of “unclaimed features,” the Oura Ring Application is closer to the “insignificant features” end because, while it allows the user to access and interpret data tracked by their Oura Ring, it does not materially impact the functionality of the Oura Ring or its structure.10 See Teva 8 F.4th at 1361 (explaining that “like the coextensiveness requirement itself, the concept of unclaimed features is best viewed as part of a spectrum”).” slip op. at 27

  Patent outcomesUS 10,281,953 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips
  Patents in suitUS 10,281,953
• MSN Laboratories Private Ltd. / MSN Pharmaceuticals Inc. v. Bausch Health Ireland LimitedNo claims unpatentable
  PTAB · Jan 27, 2026 · IPR2023-00016 · APJ Michael A Valek · IPR · Remand

  On remand, the Board held claims 1–6 not shown unpatentable because unexpected results outweighed the prima facie obviousness case, and granted Patent Owner’s motion to exclude.

  RulingsRemand decision

  • RemandOther

    “the Court of Appeals for the Federal Circuit (“Federal Circuit”)See Paper 83 (“CAFC Decision”). The Federal Circuit did not disturb our determination that Petitioner “established a prima facie case of obviousness.” See CAFC Dec. 6–8. However, it took issue with the unexpected results analysis in the Decision, explaining that “without more explanation from the Board as to its determination that the experiments [offered by Patent Owner to show unexpected results] compared the challenged claims to the closest prior art, we cannot reach a judgment on MSN’s challenges to the Board’s holding of non-obviousness.” Id. at 14. Accordingly, the Federal Circuit vacated the Decision and remanded the case for further consideration of the unexpected results evidence. Id.” slip op. at 2

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner

    “We agree with Patent Owner and credit Dr. Davies’s testimony (Ex. 2024 ¶¶ 210–215) that a POSA would not have expected the Glu3 substitution to produce such a result. Indeed, the premise for Petitioner’s “conservative substitution” rationale is that the Glu3 substitution would have been expected to produce an analog having similar properties to human uroguanylin. See, e.g., Pet. 1, 36 (stating that a POSA “would have expected this particular conservative substitution to retain excellent receptor-activating activity”); Reply 3 (urging that the reason to modify a known compound may be an expectation that the new compound will have “similar properties to the old”) (internal quotations omitted). Patent Owner’s HPLC data, however, demonstrate a difference in kind between the data for SP-304 (a single HPLC peak) and uroguanylin (two distinct peaks corresponding to the active and inactive topoisomer) after incubation under the same conditions. As Dr. Davies explains, “topoisomers exist as a mixture of compounds with different[] spatial conformations” that are “continuously interconverting between spatial conformations” with “varying degrees of interconversion stability.” See Ex. 2024 ¶¶ 51–56. Thus, Patent Owner’s data show that the Glu3 substitution results in a peptide that is demonstrably more stable against interconversion than the parent, unmodified peptide.” slip op. at 35

  • Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia with nexusObjective indicia outweighedDecided for patent owner

    “We find Patent Owner’s evidence persuasive to show that the Glu3 substitution results in an unexpected improvement in interconversion stability. As explained above, RP-HPLC was a known technique for separating the topoisomers of human uroguanylin. Ex. 2010, 230–231; Ex. 2011, 27–28; Ex. 2020, 223; Ex. 2028, TRUL00018269; see also Ex. 1063 ¶¶ 37, 40 (Petitioner’s expert confirming same). It was also known that one of human uroguanylin’s topoisomers was biologically active, whereas the other, i.e., what we and the parties refer to as the “inactive” topoisomer, had significantly less or no activity at the same concentration. Ex. 2011, 31 (“compound I shows significant activity in the cGMP producing assay, whereas compound II is practically inactive”); see also Ex. 2010, 238–239 (Fig. 8) (showing the “A isomer” had a potency “with a minimal concentration between 10-7and 10-8 M,” but that the B isomer “had virtually no effect on cGMP level at 10-6 M”); Ex. 2074, 48 (compound II “showed maximal 10% of the activity of compound I at 10-6 M”). The chromatograph for uroguanylin in Patent Owner’s data is consistent with these teachings, showing two peaks representing the active and inactive topoisomers. Compare Ex. 2028, TRUL00018269 (Fig. 1) with Ex. 2011, 28 (Fig. 2). The chromatograph for SP-304 shows a markedly different result, i.e., a “single peak,” which was confirmed “using the cGMP T84 cell assay” to represent “the fully active conformer of SP-304.” Ex. 2028, TRUL00018269; Ex. 2024 ¶¶ 208–209. We agree with Patent Owner and credit Dr. Davies’s testimony (Ex. 2024 ¶¶ 210–215) that a POSA would not have expected the Glu3 substitution to produce such a result. Indeed, the premise for Petitioner’s “conservative substitution” rationale is that the Glu3 substitution would have been expected to produce an analog having similar properties to human uroguanylin. See, e.g., Pet. 1, 36 (stating that a POSA “would have expected this particular conservative substitution to retain excellent receptor-activating activity”); Reply 3 (urging that the reason to modify a known compound may be an expectation that the new compound will have “similar properties to the old”) (internal quotations omitted). Patent Owner’s HPLC data, however, demonstrate a difference in kind between the data for SP-304 (a single HPLC peak) and uroguanylin (two distinct peaks corresponding to the active and inactive topoisomer) after incubation under the same conditions. As Dr. Davies explains, “topoisomers exist as a mixture of compounds with different[] spatial conformations” that are “continuously interconverting between spatial conformations” with “varying degrees of interconversion stability.” See Ex. 2024 ¶¶ 51–56. Thus, Patent Owner’s data show that the Glu3 substitution results in a peptide that is demonstrably more stable against interconversion than the parent, unmodified peptide.” slip op. at 34

  • ExcludeMotion to exclude, grantedGranted

    “motion. The American Peptide letter contains out of court statements from a third party submitted by the EPO opponent. The statements in the letter were not made under oath, nor is there evidence that Patent Owner was ever able to question the author of that letter or anyone else with personal knowledge of the statements therein. Petitioner argues that the American Peptide letter is evidence “to doubt that the ‘singular peak’ for uroguanylin in Liu represents the active topoisomer of uroguanylin” because it evidences that American Peptide “provided its customers with the ‘B’ (i.e., inactive) form of uroguanylin at the time.” Pet. Remand Resp. 25. That is, Petitioner relies on the American Peptide letter for the truth of the matters asserted therein. Such use plainly implicates the rule against hearsay and falls squarely within our prior reasoning for excluding the Currie submission portion of Exhibit 1067. We incorporate that analysis herein. See Dec. 61–72. Petitioner asserts that the American Peptide letter is admissible under the residual hearsay exception in FRE 807. MTE Opp. 3–5. We disagree. The American Peptide letter was submitted by the EPO opponent specifically for the purpose of opposing a foreign counterpart to the ’786 patent. We see no reason to distinguish it from the other materials previously excluded as hearsay in the Currie submission. Petitioner’s assertion that it contains sufficient guarantees of trustworthiness because it was “provided by a neutral third-party” (American Peptide) and “an individual having first- hand knowledge, [American Peptide Company’s] VP of sales and marketing” is speculation. See id. at 3–4. Based on the record before us, Patent Owner has never been afforded an opportunity to examine anyone regarding the statements in this letter or even confirm that it is, in fact, a letter from the American Peptide Company. The mere fact that it was submitted in a foreign patent proceeding does not make it any more trustworthy than any other untested assertion offered by an adverse party in a legal proceeding.” slip op. at 58

  Patent outcomesUS 7,041,786 not shown unpatentable
  § 103 obviousness
  Patents in suitUS 7,041,786
• MSN Laboratories Private Ltd. / MSN Pharmaceuticals Inc. v. Bausch Health Ireland LimitedNo claims unpatentable
  PTAB · Jan 27, 2026 · IPR2022-00722 · APJ Michael A Valek · IPR · Remand

  Claims 1–6 were not shown unpatentable because the unexpected results from the Glu3 substitution outweighed the prima facie obviousness showing; Patent Owner’s motion to exclude was granted.

  RulingsRemand decision

  • RemandOther

    “More specifically, the Federal Circuit identified “three reasons” why “the Board’s determination that the[se] experiments compared the claimed invention with the closest prior art lack[ed] adequate explanation” and instructed us to address these issues on remand. See CAFC Dec. 11–13. First, the Court stated we “should determine, based on the evidence put forward by the parties, whether plecanatide exhibits topoisomerism and whether the testing of the challenged claims should encompass both the active and inactive forms.” Id. at 12.3 Second, the Court instructed us to reconsider what the closest prior art compound is in view of Patent Owner’s “contention that highly pure A-form uroguanylin could be maintained as a lyophilized powder,” noting that “[i]f it is true . . . that uroguanylin can be maintained and therefore tested in its active A form as a lyophilized powder, that would support that the experiments [which were conducted in solution] did not use the closest prior art.” Id. Third, the Court observed that the Decision did not sufficiently address “whether the experiments submitted by [Patent Owner] actually used” the closest prior art and instructed the Board “to reevaluate the experimental evidence consistent” with the determinations noted above. Id. at 12–13.” slip op. at 3

  • Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia outweighedDecided for patent owner

    “In sum, we find that there is a sufficient nexus between Patent Owner’s results and the challenged claims and that those results are reasonably commensurate with the same. Accordingly, for all of reasons explained above, the unexpected results Patent Owner relies upon are probative of non-obviousness. E. Conclusion for Ground 1 Weighing the record as a whole in view of the findings and analysis above as well as our findings and analysis relating to Petitioner’s prima facie showing in the Decision, we conclude that Petitioner has not met its burden to show that claim 1 would have been obvious over Currie and Li. The evidence suggesting that it would have been obvious to make the Glu3 substitution because it is a conservative substitution (see Dec. 20–38 (§ III.E.ii)) is substantially outweighed by Patent Owner’s comparatively strong evidence demonstrating unexpected results relating to improved interconversion stability, potency, and binding affinity from the Glu3 substitution. See Millennium Pharms., Inc. v. Sandoz Inc., 862 F.3d 1356, 1368 (Fed. Cir. 2017) (“Evidence of objective indicia [such as unexpected results] ‘can be the most probative evidence of nonobviousness in the record,’ and . . . enable[s] ‘the court to avert the trap of hindsight.’”) (quoting Leo Pharm. Prods., Ltd. v. Rea, 726 F.3d 1346, 1358 (Fed. Cir. 2013). Indeed, the interconversion and potency categories of Patent Owner’s unexpected results showing are particularly strong such that even without the additional results in Liu, we would still reach the same ultimate conclusion on obviousness. Accordingly, Petitioner has not shown by a preponderance of the evidence that claim 1 is unpatentable.” slip op. at 56

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

    “same combination of Currie and Li for the limitations of claim 1 and the similar limitations recited in the other independent claims. In the Decision, we found that, based on the teachings in those references, an ordinarily-skilled artisan would have been motivated both to select human uroguanylin as a lead compound and modify its sequence by making a conservative Glu3 substitution for uroguanylin’s Asp3. Dec. 15–37. We did not, however, credit Petitioner’s other purported rationales for that modification. Id. at 34–37. Those findings were not disturbed on appeal. See CAFC Dec. 6–8 (rejecting 9 The Leahy-Smith America Invents Act, Pub. L. No. 112–29, 125 Stat. 284 (2011) (“AIA”), included revisions to 35 U.S.C. § 103 that became effective after the filing of the application that led to the ’786 patent. Therefore, we apply the pre-AIA version of 35 U.S.C. § 103. 10 U.S. Pat. 5,489,670, issued Feb. 6, 1996 (Ex. 1005) (“Currie”). 11 Z. Li et al., Purification, cDNA Sequence, and Tissue Distribution of Rat Uroguanylin, 68 Regulatory Peptides 45–56 (1997) (Ex. 1006) (“Li”). 12 R. Narayani et al., Polymer-coated Gelatin Capsules as Oral Delivery Devices and their Gastrointestinal Tract Behavior in Humans, 7 J. Biomater. Sci. Polymer Edn. 39–48 (1995) (Ex. 1007) (“Narayani”). 13 M. Campieri et al., Oral Budesonide is as Effective as Oral Prednisolone in Active Crohn’s Disease, 41 Gut 209–214 (1997) (Ex. 1008) (“Campieri”). 14 U.S. Pat. 5,359,030, issued Oct. 25, 1994 (Ex. 1009) (“Ekwuribe”). Patent Owner’s alternative arguments for affirmance). We incorporate by reference the portions of the Decision addressing Petitioner’s prima facie showing herein. See Dec. 8–37 (§§ III.A–D and E.i–ii). We consider the findings and explanation therein to the extent it bears on our analysis below.” slip op. at 10

  • ExcludeMotion to exclude, grantedGranted

    “motion. The American Peptide letter contains out of court statements from a third party submitted by the EPO opponent. The statements in the letter were not made under oath, nor is there evidence that Patent Owner was ever able to question the author of that letter or anyone else with personal knowledge of the statements therein. Petitioner argues that the American Peptide letter is evidence “to doubt that the ‘singular peak’ for uroguanylin in Liu represents the active topoisomer of uroguanylin” because it evidences that American Peptide “provided its customers with the ‘B’ (i.e., inactive) form of uroguanylin at the time.” Pet. Remand Resp. 25. That is, Petitioner relies on the American Peptide letter for the truth of the matters asserted therein. Such use plainly implicates the rule against hearsay and falls squarely within our prior reasoning for excluding the Currie submission portion of Exhibit 1067. We incorporate that analysis herein. See Dec. 61–72. Petitioner asserts that the American Peptide letter is admissible under the residual hearsay exception in FRE 807. MTE Opp. 3–5. We disagree. The American Peptide letter was submitted by the EPO opponent specifically for the purpose of opposing a foreign counterpart to the ’786 patent. We see no reason to distinguish it from the other materials previously excluded as hearsay in the Currie submission. Petitioner’s assertion that it contains sufficient guarantees of trustworthiness because it was “provided by a neutral third-party” (American Peptide) and “an individual having first- hand knowledge, [American Peptide Company’s] VP of sales and marketing” is speculation. See id. at 3–4. Based on the record before us, Patent Owner has never been afforded an opportunity to examine anyone regarding the statements in this letter or even confirm that it is, in fact, a letter from the American Peptide Company. The mere fact that it was submitted in a foreign patent proceeding does not make it any more trustworthy than any other untested assertion offered by an adverse party in a legal proceeding. For these reasons, we grant Patent Owner’s motion to exclude page 86 of Exhibit 1067.” slip op. at 58

  Patent outcomesUS 7,041,786 not shown unpatentable
  Claim construction§ 103 obviousness
  Patents in suitUS 7,041,786

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.