• Abbott Laboratories v. Miracor Medical SASome claims unpatentable
  PTAB · Jun 10, 2026 · IPR2025-00114 · APJ Annette R Reimers · IPR · Final written decision

  Claims 1, 2, 4, 5, 7, 8, 11, 12, 14–16, 18, and 19 are unpatentable under §103; claim 20 was not shown unpatentable.

  RulingsFinal written decision

  • Expert testimonyDenied

    “IV. PATENT OWNER’S MOTION TO EXCLUDE Patent Owner seeks to exclude portions of Dr. Wieselthaler’s Declaration (Exhibit 1041), portions of Mr. Crosby’s Reply Declaration (Exhibit 1042), portions of the deposition transcript of Dr. Wieselthaler (Exhibit 2028), and the exhibits “upon which that testimony is based” (Exhibits 1015, 1038, 1044, 1046, 1049, and 1050). Mot. 1. According to Patent Owner, the Motion was made “to preserve objections previously made in the record.” Id. (citations omitted). Patent Owner did not timely move to strike any of the evidence at issue as being outside the scope of reply evidence. Patent Owner asserts that because an inter partes review must be based on prior art consisting of patents or printed publications (citing 35 U.S.C. § 311(b)), the testimony of Mr. Crosby and Dr. Wieselthaler concerning “various physical devices allegedly known” to a person of ordinary skill in the art is inadmissible, along with all of the exhibits (consisting of printed materials such a journal abstracts, press releases, and papers) related to those physical devices. Id. at 3–4; see also Mot. Reply 1–4 (arguing that “devices that Petitioner’s witnesses assert were the basis of an inter partes review”). According to Patent Owner, Dr. Wieselthaler was unable to “link two of these physical devices to the printed prior art asserted in this [inter partes review], but those attempts fell apart during his cross examination.” Id. at 4. Patent Owner further reasons that because the evidence “cannot be the basis” of an inter partes review, it “has no tendency to make any fact of consequence in this trial more or less probable,” “is irrelevant and not admissible,” “presents substantial danger of confusing the issues, causing undue delay, and wasting time in this trial,” and “are not ‘based on sufficient facts[,] the product of reliable principles and methods[, or] ‘a reliable application of the principles and methods to the facts of the case.’” Id. at 7 (citing Fed. R. Evid. 401–403, 702) (modification in original). With regard to Exhibits 1015, 1038, 1044, 1046, 1049, and 1050, Petitioner argues, and we agree, that Patent Owner identifies no plausible legal theory for their inadmissibility based on the contention that they discuss physical devices. See Mot. Resp. 3. We also agree with Petitioner that the exhibits are not “the basis for any ground” asserted in this proceeding, and may be properly relied upon by Dr. Wieselthaler and Mr. Crosby as support for their rebuttal testimony directed to Patent Owner’s arguments disputing Petitioner’s asserted motivation to combine the prior art relied upon in the instituted grounds. See id. at 3–4. In regard to the disputed testimony of Dr. Wieselthaler and” slip op. at 77

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther

    “1. “magneto coupling” Claim 1 recites, in relevant part, “a second magnetic device . . . positioned to magnetically drive rotation of the magnetically driven rotor via a magneto coupling with the first magnetic device.” Ex. 1001, 5:34–37. Claim 11 recites, in relevant part, “the second magnetic device positioned axially closer to the first magnetic device than to the magnetically driven rotor so as to magnetically drive rotation of the magnetically driven rotor relative to the one or more walls via a magneto coupling with the first magnetic device.” Id. at 6:42–48. Petitioner argues that “magneto coupling” means “a transfer of torque from one rotating permanent magnetic component to another rotating permanent magnetic component via a magnetic field.” Pet. 8–9 (citing Ex. 1003 ¶¶ 68–87). According to Petitioner, this construction is consistent with the ’879 patent, which describes “a coupling between two rotating ‘bar magnets’—a drive wheel rotates one bar magnet which causes another bar magnet (connected to a rotor) to rotate.” Id. (citing Ex. 1003 ¶¶ 54–55 (analyzing Ex. 1001, 2:28–52, 4:44–64, Fig. 2)). Patent Owner argues that “magneto coupling” should be afforded “its plain and ordinary meaning, which would encompass a magnetic coupling through both rotating magnets and the use of a rotating magnetic Owner directs us to the testimony of Mr. Leschinsky, who explains that a person of ordinary skill in the art would have understood the ’879 patent to use “magneto coupling” to generally describe “a way to couple the rotor to a drive element while sealing the two from one another and avoiding use of a direct mechanical coupling.” Ex. 2015 ¶ 67. According to Patent Owner, “Petitioner provides no recognizable basis for limiting the plain meaning of magnetic coupling to one type of magnet and excluding another type of magnet.” PO Resp. 6–7 (citing Johnson Worldwide Associates, Inc., v. Zebco Corp., 175 F.3d 985, 989–992 (Fed. Cir. 1999)). We agree with Patent Owner that Petitioner does not provide a sufficient basis for limiting the plain meaning of “magneto coupling.” That the ’879 patent describes embodiments using bar magnets does not serve to require the use of permanent magnets for the recited “magneto coupling.” See Sisvel Int’l S.A. v. Sierra Wireless, Inc., 81 F.4th 1231, 1236 (Fed. Cir. 2023) (quoting Phillips, 415 F.3d at 1323 (“[A]lthough the specification often describes very specific embodiments of the invention, we have repeatedly warned against confining the claims to those embodiments.”)). Moreover, the claim language here is not so limited. 13 Patent Owner notes that Petitioner’s grounds of unpatentability based on Wampler and Bourque depend on the disclosure only of electromagnetic drives in each reference, implying that “Petitioner does not believe its own proposed narrower construction.” PO Resp. 6; see also Pet. 8 (Petitioner alleging that in the Parallel Proceeding Patent Owner “conflates ‘magneto coupling’ . . . with a stator drive using a stationary electromagnet, instead of a rotating magnet, to rotate the rotor magnet,” and asserting that as the basis for Petitioner’s reliance on Wampler and Bourque as teaching a “magneto coupling” in this proceeding (citing Ex. 1019, 7; Ex. 1003 ¶¶ 84–87)).” slip op. at 24

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

    “reasons discussed above. See supra Section III.D.3. Accordingly, because Petitioner’s contentions are premised on an unsupported claim construction that we reject, Petitioner fails to show how Wampler teaches or suggests “a magnetically driven rotor . . . axially adjacent to a first magnet device,” as required by claims 1 and 11, as well as by claims 2, 4, 5, 7, 8, 11, 12, 14– 16, and 18–20, which depend from either claim 1 or claim 11. In its Reply, Petitioner suggests that “[u]nder [Patent Owner’s] construction from the [Patent Owner Response], Wampler also teaches or suggests this limitation,” because Patent Owner “concedes [that] ‘axially adjacent’ components ‘have” slip op. at 36

  Patent outcomesUS 11,572,879 mixed
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,572,879
• Samsung Electronics Co., Ltd. / Samsung Electronics America, Inc. v. Power2b, Inc.All claims unpatentable
  PTAB · Mar 13, 2026 · IPR2021-01266 · APJ John D Hamann · IPR · Remand

  On remand, the Board held claims 29, 36–38, 44–46, 48, 49, and 56–58 unpatentable as obvious over Reime, with additional grounds also supporting the challenged claims.

  RulingsRemand decision

  • ExcludeMotion to exclude, deniedDenied

    “In addition, Patent Owner filed a Motion to Exclude certain of Petitioner’s evidence (Paper 32) and Petitioner filed an Opposition (Paper 33). We denied this motion. See Final Dec. 58–61.” slip op. at 3

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner

    “transmission paths. See Pet. Reply 14–15; PO Sur-reply 15. And we agree with both parties that the light that is transmitted directly through the plate to the sensor element does not have intervening reflections—such is consistent with the plain and ordinary meaning of “directly to.” See PO Resp. 31–32; Pet. Reply 14–15; PO Sur-reply 15. Nothing in claim 48’s language, however, requires that all of the reflected light be transmitted directly to the sensor element, which Patent Owner argues. Ex. 1001, 70:32–35; PO Resp. 31–32; PO Sur-reply 14–16. Rather, we agree with Petitioner that the claim language “merely requires that some light reflected by the object goes ‘directly to’ at least one sensor element once it is transmitted through the viewing plane defining plate.” Pet. Reply 14. We also agree that “none of these dependent claims purport to be exclusive of one another.” Id. at 15. Rather, claims 46–48 simply require some light be transmitted (or propagated) for their particular transmission path, without reciting all light. See Ex. 1001, 70:24–35.” slip op. at 13

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

    “We find Petitioner’s arguments based on Reime alone insufficient. Thus, we find that Petitioner does not show by a preponderance of the evidence that claim 49 is rendered obvious by Reime alone.” slip op. at 52

  • Obviousness (§103) › KSR rationalesUnpatentableUnpatentable

    “And in view of the above, we find persuasive Dr. Bederson’s testimony that “[c]hoosing a multi-element detector or a single-element detector would have been a simple design choice using commercially available detectors.” Ex. 1002 ¶ 117. Accordingly, we find that one of ordinary skill in the art would have found it obvious for Reime’s receivers to be implemented using discrete single-element detectors. See KSR, 550 U.S. at 417 (“When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.”). We find unavailing Patent Owner’s argument that “Petitioner relies on expert testimony to gap-fill missing elements regarding Reime’s failure to disclose or suggest the different claim arrangements of detector elements in a ‘detector assembly.’” PO Resp. 78 (citing Ex. 1002 ¶¶ 111–119; Ex. 2056 ¶ 171). Rather, in light of Reime’s teachings, coupled with the general knowledge of one of ordinary skill in the art, it would have been obvious to employ discrete single-element detectors for Reime’s receivers. See Koninklijke Philips N.V. v. Google LLC, 948 F.3d 1330, 1338 (Fed. Cir. 2020) (finding obviousness can rely on supported expert testimony to supply an element of a claim). We appropriately consider such evidence of the knowledge that one of ordinary skill in the art would have had as part of our obviousness analysis. See Randall Mfg. v. Rea, 733 F.3d 1355, 1362–63 (Fed. Cir. 2013). Moreover, “AAPA can be important evidence of general background knowledge, and general knowledge can be used to supply a missing claim 1371, 1378–79 (Fed. Cir. 2025). Here, Petitioner relies on the cited AAPA as evidence of one of ordinary skill in the art’s general knowledge at the time of the ’093 patent, and the AAPA is not the basis for this ground. See Pet. 4, 42–43; Pet. Remand 4–5. As Shockwave Med. explains, Federal Circuit “case law has long recognized numerous permissible uses for general background knowledge in an IPR such as, ‘for example, furnishing a motivation to combine, or supplying a missing claim limitation.” 142 F.4th at 1378–79 (quoting Qualcomm Inc. v. Apple Inc., 24 F.4th 1367, 1376 (Fed. Cir. 2022) (citing Randall Mfg., 733 F.3d at 1362; Koninklijke, 948 F.3d at 1337–38)).” slip op. at 31

  Patent outcomesUS 9,569,093 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 9,569,093
• Samsung Electronics Co., Ltd. / Samsung Electronics America, Inc. v. Power2b, Inc.All claims unpatentable
  PTAB · Mar 13, 2026 · IPR2021-01239 · APJ John D Hamann · IPR · Remand

  On remand, the Board held claims 17, 18, 21, 22, 26, and 30 unpatentable as obvious over Reime, with claims 17, 18, 21, 22, and 30 also obvious over Reime and Hinckley.

  RulingsRemand decision

  • ExcludeMotion to exclude, deniedDenied

    “In addition, Patent Owner filed a Motion to Exclude certain of Petitioner’s evidence (Paper 28) and Petitioner filed an Opposition (Paper 34). We denied this motion. See Paper 41, 47–50.” slip op. at 3

  • Skill levelSkill level board ownOther

    “one having ordinary skill in the art at the time of the invention of the ’850 patent: one who “would have had a bachelor’s degree in electrical engineering, computer engineering, computer science, or a related field, and . . . years of experience in the research, design, development, and/or testing of touch and/or proximity sensors, human-machine interaction and 3 The Leahy-Smith America Invents Act (“AIA”) included revisions to 35 U.S.C. § 103 that became effective on March 16, 2013. Because the ’850 patent issued from an application filed before March 16, 2013, we apply the pre-AIA version of the statutory basis for unpatentability. 4 US 2003/0034439 A1, published Feb. 20, 2003 (Ex. 1010, “Reime”). 5 US 2002/0021278 A1, published Feb. 21, 2002 (Ex. 1011, “Hinckley”). Petitioner lists the combination of Reime and Hinckley as a separate asserted ground for claim 26. We combine these two asserted grounds into one as they rely on the same combination. additional education substituting for experience and vice versa.” Final Dec. 8–9. This definition for one having ordinary skill was not the subject of appeal, and we maintain it for purposes of this Final Written Decision on Remand. Moreover, it is consistent with the ’850 patent and the asserted prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 8

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

    “PO Resp. 17–29; Pet. Reply 8–15; PO Sur-reply 6–11. We construed this term in the Final Written Decision. Final Dec. 10–24. In particular, we concluded that (i) “detector assembly” means “two or more detector elements that detect electromagnetic radiation,” and (ii) a detector assembly is not required to be physically separate from (i.e., not interspersed with) a pixel array. Id. at 20, 22. The Federal Circuit found the first part of our construction erroneous. Appeal Dec. 7–10. In particular, the Federal Circuit concluded that “[t]he element.” Id. at 8. In addition, to guide the Board’s analysis on remand, the Federal Circuit construed “the terms ‘at an edge’ and ‘at least one edge’ [to] require a detector assembly to be arranged along one or more edges of a viewing plane defining plate.” Id. at 10–11. In other words, the Federal Circuit “clarif[ied] that arranging a detector assembly ‘at,’ ‘along,’ or ‘about’ ‘at least one edge’ or ‘an edge’ does not limit the detector assembly to being arranged entirely on ‘one edge.’” Id. at 12.” slip op. at 9

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

    “the Federal Circuit already has concluded that claim 15 is obvious in view of Reime. Appeal Dec. 9–10. Claim 17 further recites “wherein the detector assembly comprises: a support substrate, and an arrangement of detector elements.” Ex. 1001, 67:15–18. We agree with Petitioner and find that Reime teaches these further limitations. Pet. 34–35; Pet. Remand 2–4; Pet. Resp. Remand 1–3. First, as we found in the Final Written Decision, Reime’s receivers 30 and 32 are two detector elements that detect electromagnetic radiation (i.e., light), and Reime’s receivers 30 and 32, collectively, comprise a detector assembly. Final Dec. 27–28 (citations omitted). Moreover, Reime’s two receivers 30 and 32 comprise a detector assembly having multiple detector elements (e.g., two receivers) to teach “an arrangement of detector elements.” Ex. 1010 ¶¶ 73, 86, Figs. 9A–9C; Ex. 2060,7 127:17–18; Pet. 32–33; Pet. Reply 20; Pet. Remand 3. In addition, as we found in the Final Written Decision, Reime teaches that each of receivers 30 and 32 are centered on opposite edges of the plate. 7 Deposition Transcript of Dr. Benjamin Bederson (Apr. 7, 2022). Ex. 1010, Fig. 6A, ¶ 82) (affirming that Reime teaches having one light receiver (e.g., 30 or 32) on each side of a four-sided touch pad). In further support, we agree with Petitioner and find that Reime teaches that receivers 30 and 32 “are mounted in the peripheral area surrounding the LCD 92.” Pet. 32–33; Ex. 1010 ¶ 86; see also id. at Figs. 9A–9C (showing that the receivers are positioned at the edge of the LCD screen); infra annotated Fig. 9E (showing receivers 30 and 32 along edges of the LCD). Accordingly, we find Reime’s detector assembly that comprises receivers 30 and 32 is arranged along two edges (one edge for each receiver) of the LCD, which meets the Federal Circuit’s construction for being arranged at at least one edge. See supra Section III (concluding “at least one edge” means “arranged along one or more edges”) (emphasis added).” slip op. at 12

  Patent outcomesUS 8,624,850 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 8,624,850
• Lenovo (United States) Inc. v. Intellectual Ventures, II LLCAll claims unpatentable
  PTAB · Feb 18, 2026 · IPR2024-00124 · APJ John D Hamann · IPR · Final written decision

  Claims 1–4, 6, 7, 10–14, and 16 are unpatentable as obvious over the Neufeld grounds; the Board found the IPMI and Lawrence grounds insufficient.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “time it was made, we consider the level of ordinary skill in the pertinent art at the time of the invention. Graham v. John Deere Co., 383 U.S. 1, 17 (1966). In assessing the level of ordinary skill in the art, various factors may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC, Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (citing Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962–63 (Fed. Cir. 1986)). “[O]ne or more factors may predominate.” Id. In our Decision on Institution, we adopted the definition Petitioner proposes for one having ordinary skill in the art at the time of the invention of the ’140 patent. Dec. on Inst. 7–8. Namely, we found that one of ordinary skill in the art “would have had a Bachelors’ degree in electrical or computer engineering or a comparable field of study, plus approximately two to three years of professional experience in the field of computer and/or” slip op. at 7

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

    “same claim construction standard that would be used in a civil action under 35 U.S.C. § 282(b), following the standard articulated in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc). 37 C.F.R. § 42.100(b); 83 Fed. Reg. 51,340, 51,340–41, 51,343 (Oct. 11, 2018). In applying such standard, claim terms generally are given their ordinary and customary meaning, as would be understood by a person of ordinary skill in the art, at the time of the invention and in the context of the entire patent disclosure. Phillips, 415 F.3d at 1312–13. “In determining the meaning of the disputed claim limitation, we look principally to the intrinsic evidence of record, examining the claim language itself, the written description, and the prosecution history, if in evidence.” DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 469 F.3d 1005, 1014 (Fed. Cir. 2006) (citing Phillips, 415 F.3d at 1312–17). in claim 1 means “said managed network device.” Pet. 9. Patent Owner does not dispute this construction. We adopt Petitioner’s proposed construction for this term as it appears to be consistent with the Specification’s use of “element” as referring to networked devices, and with the overall claim. See generally Ex. 1002.” slip op. at 8

  • Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)Term construed petitioner construction§112(f) appliesDecided for petitioner

    “First, Petitioner argues that “an out of band access connection means” is a means-plus-function term with the recited function being “connecting said one or more network services or remote users with said secure management access controller for management of said network device.” Id. at 10. Petitioner argues that the function’s corresponding structure is “one or more of the following networks: a Public Switched Telephone Network (PSTN) (2:45–57, 3:2–4, 12:37-61), an Integrated Services Digital Network (ISDN) (2:45–57), a cellular network (6:14–21, 7:60–62, 12:37–61), an Ethernet network (12:37–61), a wireless network, and/or a Digital Subscriber Line (DSL) (12:37–61, 15:55–60), where the one or more networks use one or more of the following protocols: [Simple Network Management Protocol (“SNMP”)], TFTP, FTP, DNS, SysLog, Telnet, SSH, HTTP, HTTPs, point to point IP, and/or XML (8:30–38).” Id. Second, Petitioner argues that “virtual management interface connection means” is a means-plus-function term with the following recited with said secure management access controller’; (ii) ‘provides logical separation of management data from user data,’ and (iii) ‘utilizes user interfaces of said managed network element for connecting said one or more network services or remote users with said secure management access controller.’” Id. at 10–11. Petitioner argues that the functions’ corresponding structure is a VPN. Id. at 11 (citing Ex. 1002, 6:22–44, 6:63– 7:5, 12:5–21).” slip op. at 9

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

    “Lastly, we determine that we do not need to construe any other terms to resolve the disputes between the parties. See, e.g., Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 and only to the extent necessary to resolve the controversy.’”).” slip op. at 11

  Patent outcomesUS 7,325,140 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 7,325,140
• Lenovo (United States) Inc. v. Intellectual Ventures, II LLCAll claims unpatentable
  PTAB · Feb 18, 2026 · IPR2024-00109 · APJ John D Hamann · IPR · Final written decision

  Claims 1–3, 6–9, 12, and 14–17 are unpatentable as obvious over grounds involving Neufeld; the Board found the grounds involving IPMI and Huckins insufficient.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “In our Decision on Institution, we adopted the definition Petitioner proposes for one having ordinary skill in the art at the time of the invention of the ’016 patent. Dec. on Inst. 8–9. Namely, we found that one of ordinary skill in the art “would have had a Bachelors’ degree in electrical or computer engineering or a comparable field of study, plus approximately two to three years of professional experience in the field of computer and/or network design and security or other relevant industry experience,” and that “[a]dditional graduate education could substitute for professional experience, and significant experience in the field could substitute for formal education.” Id. (citing Pet. 6 (citing Ex. 1003 ¶ 56)). Patent Owner does not address Petitioner’s definition, nor provide its own. See generally PO Resp. Because Petitioner’s definition of the level of skill in the art is consistent with the ’016 patent and the asserted prior art, we maintain it for purposes of this Final Written Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC, 57 F.3d at 1579; In re Oelrich, 579 F.2d 86, 91 (CCPA 1978).” slip op. at 9

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

    “We determine that we do not need to construe any term to resolve the disputes between the parties. See, e.g., Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. the extent necessary to resolve the controversy.’”).” slip op. at 10

  • Expert testimonyPatent owner expert discountedDecided for patent owner

    “In addition, we find not credible Dr. Mishra’s deposition testimony that Neufeld teaches only out-of-band communication, and it is not possible for a remote management command to come to remote management controller 116 via network N and through NIC 110. See Ex. 1043,22 43:5– 44:6, 49:9–50:7; PO Sur-reply 4–5. This testimony is inconsistent with Neufeld’s express teachings, which we discuss above. Compare Ex. 1043, 43:5–44:6, 49:9–50:7, with Ex. 1005 ¶¶ 11–12, 15, 34–35, 43, Figs. 1–2.” slip op. at 18

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

    “[O]bviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed invention.” See Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015); Polaris Indus., Inc. v. Arctic Cat, Inc., 882 F.3d 1056, 1068−69 (Fed. Cir. 2018) (finding that “the Board focused on what a skilled artisan would have been able to do, rather than what a skilled artisan would have been motivated to do at the time of the invention”). Petitioner’s arguments focus on that the modified version of IPMI could have been made, rather than that one of ordinary skill would have been motivated to combine the teachings to make the proffered combination. For example, Petitioner argues that the modified IPMI version is “one way to implement a side-band connection.” Pet. 62. This argues that the modified IPMI version could have been made. Petitioner also argues that one of ordinary skill in the art would have been motivated to make the combined modifications because “IPMI’s LAN Controller already has the necessary logic and hardware to send packets to [the] managed server via the PCI bus as shown in unmodified version of Fig. 12-1.” Pet. Reply 23; see also id. at 24 (arguing that “implementing the I2C sideband interface taught by IPMI using a PCI-I2C controller/bridge is a simple and logical solution on the PCI bus”). We agree with Patent Owner that Petitioner does not explain why this would be a motivation to add Huckins’s “PCI-I2C Bus Controller/Bridge” to IPMI’s teachings. E.g., PO Resp. 60; PO Sur-reply 20. And, we find persuasive Dr. Mishra’s testimony that “[r]equiring a LAN controller to offload management data onto the PCI bus only to route it back internally via the I/O Controller Hub introduces unnecessary design complexity, reduces system performance, and consumes additional bandwidth and power, all without technical justification.” Ex. 2007 ¶ 148; see also id. ¶¶ 145–146 (testifying to the modified combination’s operation). We also find unavailing Petitioner’s argument that Patent Owner’s criticisms of the modified version of Figure 12-1 “do not defeat the Petition’s showing of obviousness because ‘[i]t’s not necessary to show that a combination is the best option, only that it be a suitable option.’” Pet. Reply 26 (citing Intel Corp. v. PACT XPP Schweiz AG, 61 F.4th 1373, 1380 (Fed. Cir. 2023) (citing Intel Corp. v. Qualcomm Inc., 21 F.4th 784, 799– 800 (Fed. Cir. 2021)). But Petitioner does not address why the modified version of IPMI is suitable. Nor does Petitioner persuasively counter Dr. Mishra’s testimony as to why one of skill in the art would not have made the proposed combination. See Pet. Reply 24–26; Ex. 2007 ¶¶ 145–148. In addition, in our view, Petitioner’s modification of IPMI to add Huckins’s “PCI-I2C Bus Controller/Bridge” is driven by impermissible hindsight and the desire to locate a distinct, second bus (the PCI bus) as required by the claims. Petitioner’s arguments to this end rely impermissibly on the ’016 patent itself as a roadmap. See Grain Processing Corp. v. Am.-Maize Prods. Co., 840 F.2d 902, 907 (Fed. Cir. 1988) (quoting Orthopedic Equip. Co. v. United States, 702 F.2d 1005, 1012 (Fed. Cir. patent in suit as a guide through the maze of prior art references, combining the right references in the right way so as to achieve the result of the claims in suit.”’)); Metalcraft of Mayville, Inc. v. The Toro Co., 848 F.3d 1358, 1367 (Fed. Cir. 2017) (“[W]e cannot allow hindsight bias to be the thread that stitches together prior art patches into something that is the claimed invention.”). slip op. at 37

  Patent outcomesUS 8,474,016 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 8,474,016
• Luxottica Of America Inc. v. E-Vision Optics, LLCSome claims unpatentable
  PTAB · Dec 23, 2025 · IPR2024-01030 · APJ Richard H Marschall · IPR · Final written decision

  Claims 1–20, 22–31, and 33–37 are unpatentable; claims 21 and 32 were not shown unpatentable, principally because the proposed combinations failed to establish motivation to combine or the required airtight seal.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “We find that the proposals from the parties substantially overlap, such that it remains unclear whether any substantive difference exists. Notably, neither party argues that the minor differences in the proposals lead to a different outcome on any issues in this proceeding. Based on our review of the proposals, we apply Patent Owner’s proposal because it is consistent with the problems and solutions disclosed in the ’483 patent and prior art of record. See, e.g., GPAC, 57 F.3d at 1579 (approving the determination of the level of ordinary skill in the art by appeal to the references of record). The outcome of the issues addressed in this Decision would not change if we applied Petitioner’s proposal.” slip op. at 9

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

    “hermetically sealed” module does not encompass waterproof modules that are not airtight. First, as Petitioner admits, as a general matter, “[s]omething that is hermetically sealed is sealed so as to be airtight.” Pet. 28 (citing Ex. 1002 ¶ 103; Ex. 1010, 269); PO Sur-reply 16. Petitioner later tries to argue that the specification puts a different spin on this meaning, but still acknowledges that “[o]utside the context of the ’483 patent, a hermetic seal is sometimes equated with an airtight seal.” See Pet. Post-hearing 2–3 (citing Ex. 1002 ¶ 103; Ex. 1010, 269). Based on our review of the record, the “ordinary meaning” of “hermetically sealed” means “airtight,” and, as noted above, “airtight” is not the same thing as “waterproof.” Second, the claims support Patent Owner’s position by including dependent claims that separately claim a “hermetically sealed” module (claims 13 and 32) and a “waterproof” module (claims 15 and 34), strongly suggesting that the terms have a different scope to avoid rendering some claims redundant. See Ex. 1001, 11: 65–66, 12:3–4, 12:52–53, 12:55–56. Petitioner argues in its Post-hearing brief that claims requiring waterproof modules are “a narrower species” of hermetic seal, but fails to explain how hermetic, airtight, and waterproof seals would not fall within the scope of both claims using its approach. Pet. Post-hearing Reply 2. Petitioner’s earlier argument in its Reply also seems to cut against this position by asserting that the specification “treats hermitically sealing as conventional and equivalent to waterproofing,” with different dependent claims directed to two allegedly “equivalent” terms making little sense. Pet. Reply 14 (emphasis added). The most natural reading of the claim language suggests that “hermetically sealed” means airtight, and does not encompass modules that are waterproof but not airtight. Third, while the specification does not define “hermetically sealed” and uses “waterproof” and “hermetically sealed” in similar contexts, it does not suggest that “hermetically sealed” does not require an airtight seal consistent with its ordinary meaning. See Pet. Reply 14–15 (citing Ex. 1001, 6:47–53, 9:15–18, 10:47–50). Instead, the specification states that hermetic seals prevent water from contacting electronics, which remains consistent with Patent Owner’s position because airtight hermetic seals are also waterproof. See Ex. 1001, 6:47–53, 9:15–18. The specification also states that “[t]he module preferably houses any of the aforementioned electrical components in a substantially water-proof and wear resistant/moisture resistant environment and is preferably hermetically sealed.” Id. at 10:47–50 (emphasis added). This passage supports Patent Owner’s position by suggesting that the preferable “hermetically sealed” module goes beyond mere water resistance. See PO Sur-reply 16–17. slip op. at 16

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

    “2. Petitioner’s Anticipation Arguments and Evidence Petitioner argues that Howell-596 discloses every limitation of claims 1, 9, 10, 14, 15, and 18, and points to specific portions of Howell-596 and expert testimony to support its arguments. See Pet. 10–20 (citing Ex. 1002; Ex. 1003). We have reviewed the evidence and arguments of record and find that Petitioner has shown, by a preponderance of the evidence, that the limitations in claims 1, 9, 10, 14, 15, and 18 are disclosed by Howell-596 for the reasons set forth in the Petition, which we adopt as our own. See id.11 Accordingly, we find that Petitioner has established, by a preponderance of the evidence, that Howell-596 anticipates claims 1, 9, 10, 14, 15, and 18.” slip op. at 12

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

    “Based on these undisputed points and the parties’ arguments, we agree with Patent Owner that Petitioner fails to establish that a POSITA would have been motivated to locate Howell-596’s module housing 1700, which contains its UV detection system 1500, behind a user’s ear. Petitioner never squarely addresses the fact that placing Howell-596’s UV detection system behind a user’s ear would negatively impact its performance. Pet. 31–33; Pet. Reply 17–22. As a result, even if we accept Petitioner’s arguments and evidence as to the various advantages when placing electronics behind a user’s ear, it fails to establish a motivation to combine that requires placing Howell-596’s module housing 1700, and therefore its UV detection system, behind a user’s ear. Petitioner never acknowledges the readily apparent disadvantages of placing a UV detection system behind the ear, where it may not work at all. See Pet. 31–33. Nor does Petitioner argue that, in its combination, adjustments would be made to ensure accurate operation of Howell-596’s UV detection system. See id. Similarly, Petitioner notes that both Howell-596 and Howell-833 disclose UV sensors behind the ear of a user, but those teachings do not establish that placing Howell-596’s module behind the ear would ensure proper operation of its UV detection system housed within that module. See Pet. Reply 17–22. Instead, even though Howell-596 discloses a sensor behind the ear of a user, it maintains the UV detection system in a module toward the front of the temple, away from the ear. See id. at 18–19; PO Surreply 21–22; Ex. 1003 ¶ 205 (describing UV detection system 2102), Fig. 21 (showing UV detection system 2102 toward the front of the temple). Moreover, Petitioner’s reliance on the sensor placed behind the ear of the user in Howell-596 lacks weight because that sensor merely indicates that the device “is being worn by a user,” which serves a very different purpose than Howell-596’s UV detection system, which seeks to monitor a user’s exposure to UV radiation, a central purpose of Howell-596’s eyewear. See Ex. 1003 ¶ 205, code (57). Howell-833 also employs a UV sensor behind the ear, but Petitioner does not establish that it operates any differently than the “being worn” sensor in Howell-596, and therefore does not establish that Howell-596’s UV detection system would still work for its intended purposes in Petitioner’s proposed combination. See Pet. Reply 19–20.” slip op. at 29

  Patent outcomesUS 8,708,483 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR
  Patents in suitUS 8,708,483
• Luxottica Of America Inc. v. E-Vision Optics, LLCAll claims unpatentable
  PTAB · Dec 11, 2025 · IPR2024-01071 · APJ Richard H Marschall · IPR · Final written decision

  Claims 1–19 are unpatentable as obvious; the Board found each challenged claim unpatentable under at least one asserted § 103 ground.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “We find that the proposals from the parties substantially overlap, such that it remains unclear whether any substantive difference exists. Notably, neither party argues that the minor differences in the proposals lead to a different outcome on any issues in this proceeding. Based on our review of the proposals, we apply Patent Owner’s proposal because it is consistent with the problems and solutions disclosed in the ’541 patent and prior art of record. See, e.g., GPAC, 57 F.3d at 1579 (approving the determination of the level of ordinary skill in the art by appeal to the references of record). The outcome of the issues addressed in this Decision would not change if we applied Petitioner’s proposal.” slip op. at 9

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

    “Pursuant to 37 C.F.R. § 42.100(b), we apply the claim construction standard set forth in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc). Under that standard, we give the words of a claim their plain and ordinary meaning as would have been understood by one skilled in the art at the time of the invention and in the context of the entire patent disclosure. Id. at 1312–13. Only terms in controversy need be construed, and only to the extent necessary to resolve the controversy. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Here, Petitioner posits that “no claim terms require construction to resolve the obviousness challenges here.” Pet. 12. Patent Owner does not oppose Petitioner’s position or proffer any constructions of its own. See generally PO Resp. We determine that no express construction of any claim element is necessary to resolve the issues in this proceeding.” slip op. at 9

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

    “Based on our review of the record, we find Petitioner’s arguments and evidence as to the motivation to combine Howell-596 and Howell-158 persuasive. Importantly, the references themselves support the combination because Howell-158 expressly teaches the advantages of using an insulating layer with metal frames and incorporates by reference Howell-596 and its embodiments that disclose all but the insulating layer limitations of claim 1. See Pet. 15–21. While Patent Owner correctly notes that the references do not expressly teach the use of the insulating layer in the Howell-596 embodiments, the references do not teach away from that approach and at least implicitly support Petitioner’s proposed combination, which involves using an advantageous design element (an insulating layer) with another embodiment incorporated into the same document. See id.; Ex. 1006 ¶¶ 3 (incorporating Howell-596), 52–53 (disclosing the use of metal frames and the advantages of using an insulating layer with metal frames). Patent Owner does not dispute that the stated advantages of the insulating layer— preventing short circuits and reducing leakage current—would apply to the embodiments of Howell-596 when those designs incorporate a metal frame. See PO Resp. 18 (arguing that the advantages of the insulating layer only apply if metal frames are implemented in Howell-596’s system). In short, the references themselves amply support Petitioner’s motivation to combine arguments and the expert testimony Petitioner relies on in support of those arguments. See Pet. 21–24; Pet. Reply 2–10; Ex. 1002 ¶¶ 63–69.” slip op. at 19

  • Obviousness (§103) › KSR rationalesMotivation foundUnpatentable

    “POSITA would have found it obvious, through routine optimization, to select a housing module with the claimed thickness of less than or equal to 0.7 mm. See Aller, 220 F.2d at 456; In re Boesch, 617 F.2d 272, 276 (CCPA 1980) (“[D]iscovery of an optimum value of a result effective variable . . . is ordinarily within the skill of the art.”); see also Power- Kennedy Contracting Corp. v. Concrete Mixing & Conveying Co., 282 U.S. 175, 184–85 (1930) (“[O]bviously a mere change in proportion would involve no more than mechanical skill and would not amount to invention.”). Several reasons support Petitioner’s arguments, which we address in turn.” slip op. at 33

  Patent outcomesUS 8,905,541 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,905,541
• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  PTAB · Nov 17, 2025 · IPR2024-00648 · APJ Devon Zastrow Newman · IPR · Final written decision

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

  RulingsFinal written decision

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

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

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

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

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

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

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

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

  Patent outcomesUS 11,643,462 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,643,462
• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  PTAB · Nov 4, 2025 · IPR2024-00624 · APJ Sheridan K Snedden · IPR · Final written decision

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

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

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

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

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

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

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

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

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

  Patent outcomesUS 11,325,975 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,325,975
• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  PTAB · Oct 28, 2025 · IPR2024-00622 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 1–28 are unpatentable: claims 1, 6–11, 13–20, 22–24, and 26–28 as anticipated by the MSI-H Study Record; claims 2–5, 12, 21, and 25 as obvious.

  RulingsFinal written decision

  • BurdenUnpatentable

    “(“the claimed process here is not directed to a new use; it is the same use, and it consists of the same steps as described by [the prior art]. Newly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.”). After analysis of the full record, we are persuaded that the results recited in claim 1 would follow from the steps taught in the MSR, for the reasons and based on the evidence Petitioner cites above. For these same reasons, we are unpersuaded by Patent Owner’s argument that it was unknown whether the amount of pembrolizumab recited in claim 1 would be effective in producing an improved outcome compared to a reference patient without a tumor that was not MSI-H or dMMR, and Patent Owner does not dispute that the amount of pembrolizumab disclosed in the MSR (10 mg/kg every 14 days; see Ex. 1005, 4) is the same as the amount provided in the ’356 patent as being effective (10 mg/kg every 14 days; Ex. 1001, 8:48–52, 13:50–52). Regardless of the inventors’ intent in publishing the MSR as a Stage II clinical trial on the www.clinicaltrials.gov website, as discussed above, we determine that the MSR teaches selecting a patient with a metastatic MSI-H or dMMR tumor and administering an amount of pembrolizumab that would be effective. See, e.g., Ex. 1005, 4 (Arms and Interventions). The result of drug treatment inherently follows its administration. The MSR does not merely suggest that pembrolizumab may be useful in some unidentified subset of patients or suggest that some unidentified drug may be useful for MSI-H cancer patients. Instead, the MSR discloses selecting a patient with a condition recited in claim 1 and treating with the drug at the amount recited in claim 1. Contra Metabolite Labs. Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1367 (Fed. Cir. 2004) (holding that the prior art did not” slip op. at 22

  • Skill levelSkill level board ownDecided for petitioner

    “Petitioner and Patent Owner characterize one of ordinary skill in the art differently. To Petitioner, the ordinarily skilled artisan would have been a medical doctor, or a professional in a related field, with experience treating cancer or access to those with experience in clinical studies of therapeutics and to a pathologist with this experience. Pet. 11 (citing Ex. 1003 ¶ 19). To Patent Owner, the ordinarily skilled artisan would have had a medical or graduate-level degree, or equivalent work experience, in the fields of immunology, genetics, or a related field and would have experience (i) conducting immunology research relating to oncology, (ii) conducting genetics research relating to oncology, or (iii) developing and conducting clinical trials on novel cancer therapies in those fields. PO Resp. 5–6 (citing Ex. 2072 ¶¶ 31–32, 86–94). Petitioner emphasizes medical and treatment aspects in its characterization of an ordinarily skilled artisan, whereas Patent Owner emphasizes research aspects. The ’356 patent claims a method of treating a human patient with cancer having certain characteristics using pembrolizumab and the main prior art reference cited by Petitioner, MSR, discloses testing Ex. 1005. Accordingly, the relevant field of Patent Owner’s claims is treating human patients for cancer, as well as testing existing compounds for use in treatment modalities. In light of the extent of the relevant field, we determine that the level of skill in the art relevant to the claims of the ’356 patent is not limited to knowledge of and experience with conducting research relating to oncology or developing and conducting clinical trials, but includes knowledge of and experience with treating cancer patients with immunotherapy compounds, identifying the conditions these patients may have, and understanding the literature regarding clinical trials for such colorectal cancers and the associated conditions and immunotherapy.” slip op. at 9

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

    “The parties do not assert constructions of any terms recited in the challenged claims other than that their ordinary and customary meanings should apply. Pet. 10–11; PO Resp. 6. We determine that no express construction of any claim term is necessary to resolve the dispute between the parties. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We construe claims “in accordance with the ordinary and customary meaning of such history pertaining to the patent.” 37 C.F.R. § 42.100(b) (2020).” slip op. at 8

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency foundUnpatentable

    “(“the claimed process here is not directed to a new use; it is the same use, and it consists of the same steps as described by [the prior art]. Newly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.”). After analysis of the full record, we are persuaded that the results recited in claim 1 would follow from the steps taught in the MSR, for the reasons and based on the evidence Petitioner cites above. For these same reasons, we are unpersuaded by Patent Owner’s argument that it was unknown whether the amount of pembrolizumab recited in claim 1 would be effective in producing an improved outcome compared to a reference patient without a tumor that was not MSI-H or dMMR, and Patent Owner does not dispute that the amount of pembrolizumab disclosed in the MSR (10 mg/kg every 14 days; see Ex. 1005, 4) is the same as the amount provided in the ’356 patent as being effective (10 mg/kg every 14 days; Ex. 1001, 8:48–52, 13:50–52). Regardless of the inventors’ intent in publishing the MSR as a Stage II clinical trial on the www.clinicaltrials.gov website, as discussed above, we determine that the MSR teaches selecting a patient with a metastatic MSI-H or dMMR tumor and administering an amount of pembrolizumab that would be effective. See, e.g., Ex. 1005, 4 (Arms and Interventions). The result of drug treatment inherently follows its administration. The MSR does not merely suggest that pembrolizumab may be useful in some unidentified subset of patients or suggest that some unidentified drug may be useful for MSI-H cancer patients. Instead, the MSR discloses selecting a patient with a condition recited in claim 1 and treating with the drug at the amount recited in claim 1. Contra Metabolite Labs. Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1367 (Fed. Cir. 2004) (holding that the prior art did not” slip op. at 22

  Patent outcomesUS 10,934,356 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 10,934,356

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.