• Guardant Health, Inc. v. University Of WashingtonNo claims unpatentable
  PTAB · Oct 14, 2026 · IPR2022-00817 · APJ Zhenyu Yang · IPR · Remand

  On remand, the Board found Travers ’075 did not enable RCR amplification followed by SMRT sequencing and held claims 1–30 not shown unpatentable under the asserted obviousness grounds.

  RulingsRemand decision

  • RemandOther

    “B. Scope on Remand On remand, we are bound by the terms of the Federal Circuit’s mandate. Intell. Pixels Ltd. v. Sony Interactive Ent. LLC, 181 F.4th 1216, 1220 (Fed. Cir. 2026) (“An administrative agency is bound by the mandate of a reviewing court much as a lower court is bound by the mandate of a higher court.”). According to the Federal Circuit, on appeal, Patent Owner “UW argues that ‘Travers ’075 does not enable the sequencing of an RCR concatemer using PacBio’s SMRT sequencing,’ and therefore because paragraph 122 is not enabled, it cannot be relied on for disclosing amplification followed by sequencing.” Paper 50, 14. Because “[t]he Board did not reach this issue,” the Federal Circuit “remand[ed] the case for consideration of this issue by the Board in the first instance.” Id. Thus, consistent with the court’s mandate, we must decide “whether Travers ’075 enabled RCR amplification followed by SMRT sequencing.” Id. at 8.” slip op. at 4

  • BurdenNot shown unpatentable

    “A prior art reference is presumed to be enabled. Amgen, Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1355 (Fed. Cir. 2003) (holding that “a presumption arises that both the claimed and unclaimed disclosures in a prior art patent are enabled”); In re Antor Media Corp., 689 F.3d 1282, 1288 (Fed. Cir. 2012) (extending the presumption to prior art printed publications). A patent owner, however, may present persuasive evidence that the relevant disclosures of a prior art are not enabled and therefore are not pertinent prior art. Amgen, 314 F.3d at 1355; In re Antor Media, 689 F.3d at 1289 (discussing the applicant’s burden to submit rebuttal evidence of nonenablement during prosecution); Apple Inc. v. Corephotonics, Ltd., 861 Fed. App’x. 443, 450 (Fed. Cir. 2021) (“[R]egardless of the forum, prior art patents and publications enjoy a presumption of enablement, and the patentee/applicant has the burden to prove nonenablement for such prior art.”). “[T]here is no absolute requirement for a relied-upon reference to be self-enabling in the § 103 context, so long as the overall evidence of what was known at the time of invention establishes that a skilled artisan could have made and used the claimed invention.” Raytheon Techs. Corp. v. Gen. Elec. Co., 993 F.3d 1374, 1376–77 (Fed. Cir. 2021). But, “if an obviousness case is based on a non-self-enabled reference, and no other prior art reference or evidence would have enabled a skilled artisan to make the claimed invention, then the invention cannot be said to have been obvious.” Id. at 1377.” slip op. at 15

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached

    “The Federal Circuit stated that “the elements of the challenged claim are expressly taught by Travers ’075. Travers ’075 discloses performing RCR amplification followed by SMRT sequencing in a single embodiment.” Paper 50, 14. As a result, “no finding regarding a motivation to combine to arrive at those claimed elements is required.” Id. at 9. In addition, it was error to require Petitioner to show that a skilled artisan “would have had a reasonable expectation of success in performing RCR replication of SMRTbell templates followed by SMRT sequencing.” Id. at 13. “Unless remanded by [an appellate] court, all issues within the scope of the appealed judgment are deemed incorporated within the mandate and thus are precluded from further adjudication.” Engel Indus., Inc. v. Lockformer Co., 166 F.3d 1379, 1383 (Fed. Cir. 1999). Therefore, the only issue for us to decide is “whether Travers ’075 enabled RCR amplification followed by SMRT sequencing.” Paper 50, 8.” slip op. at 14

  • Expert testimonyPatent owner expert creditedDecided for patent owner

    “polymerase-template complexes in the same ZMW.” Id. (citing Ex. 1035, 39). Citing the Larrea Declaration, Petitioner contends that loading of multiple templates “is easily mitigated.” Id. at 18 (citing Ex. 1033 ¶ 19; Ex. 1035, 39). We are not persuaded by this argument either. Dr. Larrea testifies that one of the two methods to “easily mitigate[]” loading multiple templates into a single ZMW is “bioinformatically trimming the read to only the high-quality region (HQR).” Ex. 1033 ¶ 19. Dr. Larrea, however, provides no support for this testimony. In fact, he does not even explain what a “high-quality region (HQR)” is. We, thus, accord little weight to this testimony. See Xerox Corp. v. Bytemark, Inc., IPR2022-00624, Paper 9 (August 24, 2022) (precedential) (holding “conclusory and unsupported” declaration testimony is entitled to little weight).” slip op. at 26

  Patent outcomesUS 10,760,127 not shown unpatentable
  § 103 obviousness
  Patents in suitUS 10,760,127
• 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
• Candela Corporation v. Nikolai TankovichNo claims unpatentable
  PTAB · Jun 5, 2024 · IPR2023-00234 · APJ Sheridan K Snedden · IPR · Final written decision

  The Board held claims 1–28 not shown unpatentable because the asserted combinations did not establish simultaneous delivery of overlapping and non-overlapping laser beams.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Pet. 19; Ex. 1002 ¶ 77. Patent Owner does not dispute this proposed level of skill, but offers that a “POSA may have alternatively held a degree in electrical engineering.” PO Resp. 10; Ex. 4–10, 13, 15–17. We adopt Petitioner’s proposed level of ordinary skill in the art because it is consistent with the cited prior art and is undisputed on this record, and also consider Patent Owner’s additional proposal. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level).” slip op. at 9

  • Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languageTerm construed patent owner constructionDecided for patent owner

    “In this case, the Specification is devoted to the teaching simultaneous delivery of multiple laser beams. The Specification begins by stating that “[t]here are no lasers or laser handpieces on the market today that can simultaneously deliver two or more wavelengths of laser energy in spacial, fractional form.” Ex. 1001, 1:12–14. The Specification explains that “laser treatment usually requires different modalities of energy in order [to] successfully treat the pathologies to which they are applied,” but that “the sequential application of multiple wavelengths of laser energy compromises the treatment.” Id. at 1:16–25. The Specification then continues to explain various problems associated with the sequential application of multiple wavelengths. Id. at 1:25–52. The Specification concludes its introduction as follows: What is needed in the art therefore is an effective laser therapy system that can simultaneously deliver multiple wavelengths of laser energy through the use of a single laser unit without producing interference between the wavelengths within the treated tissue.” slip op. at 13

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

    “summarized above, we find Patent Owner to have the better position. In particular, we agree with Patent Owner that the combination of Hsia and Black fail to teach or suggest simultaneously delivering non-overlapping beams. The combination also fails to teach or suggest producing beam patterns that include both overlapping and non-overlapping beams. PO Resp. 34. To begin, while we recognize that Hsia discloses overlapping and non-overlapping treatment patterns, those patterns are achieved by the sequential delivery of laser beams as a user physically moves a single handpiece that delivers a single beam across the skin of a patient. Ex. 1004 ¶ 68, Figs. 8 and 9; Ex. 2001 ¶¶ 73–74. Black does not cure that deficiency as Black does not disclose treatment with non-overlapping beams. Ex. 2001 ¶ 99. Black discloses using a “refractive optics, mirror-based optical delivery device” for the simultaneous delivery of multiple overlapping laser beams. Ex. 1006 ¶¶ 12– 13. The beams align on an optical path and, using different laser beam parameters, deliver treatment at various depths within a combined beam path. Id. ¶¶ 54, 58–59. Thus, while Black may be characterized as creating overlapping beams, we do not find sufficient support for a finding that Black teaches or suggests creating non-overlapping beams for simultaneous delivery, and the claims require both. We also do not find sufficient support for Petitioner’s claim that a POSA would have found it obvious to combine Black and Hsia to simultaneously produce both overlapping beams and nonoverlapping beams, based on the disclosures in these references. See, e.g.,” slip op. at 31

  • BurdenFwd all claims patentableNot shown unpatentable

    “Claims Claims Not 35 U.S.C. § Reference(s)/ Claims Shown Shown Basis Unpatentable Unpatentable 1–28 103 Hsia, Black 1–28 Hsia, Black, 23 103 23 Negus Hsia, Black, 27, 28 103 27, 28 Altshuler Altshuler, 1–28 103 1–28 Black Altshuler, 23 103 23 Black, Negus Overall Outcome 1–28 IV. ORDER In consideration of the foregoing, it is hereby: ORDERED that Petitioner has not shown by a preponderance of the evidence that claims 1–28 of the ’481 patent are unpatentable; and” slip op. at 41

  Patent outcomesUS 10,675,481 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 10,675,481
• Bluebird Bio, Inc. v. Sloan Kettering Institute For Cancer ResearchNo claims unpatentable
  PTAB · Apr 22, 2024 · IPR2023-00074 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 1, 2, 5–8, 11, and 15 were not shown unpatentable because the cited May references did not sufficiently disclose or guide a skilled artisan to the claimed LCR fragments.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner does not dispute Petitioner’s description of the level of ordinary skill in the art. See PO Resp. Because Petitioner’s uncontested definition of one of ordinary skill in the art is reasonable and consistent with the ’061 patent and the prior art of record, we adopt Petitioner’s definition for purposes of this Decision.” slip op. at 8

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

    “Petitioner states that “that no term of the ’061 patent requires construction to resolve the challenges in this Petition.” Pet. 25 (citing Ex. 1002 ¶¶ 50–51) (footnote omitted). Patent Owner does not argue for any express claim constructions. See PO Resp. Based upon our review of the current record, we determine that no claim terms require express construction for purposes of this Decision. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, construed, “and only to the extent necessary to resolve the controversy.”).” slip op. at 8

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityReference not prior artNot shown unpatentable

    “represents the inventors’ own work, and thus the May Thesis is not prior art to the ’061 patent. PO Resp. 14–15. The May Thesis is authored by Chad May, who is a listed inventor of the ’061 patent. Id.; Ex. 1004, 3; Ex. 1001, code (75). Thus, the May Thesis represents the work of one of the ’061 inventors and is therefore ineligible as prior art under 35 U.S.C. § 102(a) based on the July 1, 2002 priority date. See, e.g., In re Katz, 687 F.2d 450, 454–455 (CCPA 1982) (a prior publication by inventors or a subset of the inventors does not qualify as prior art under 102(a)). With respect to 35 U.S.C. § 102(b), we find that the May Thesis is ineligible as prior art, even assuming that the Challenged Claims are not entitled to receive benefit of an earlier filing date. Petitioner provides evidence that the May Thesis was publicly available as of November 26, 2001. Pet. 17 (citing Ex. 1036 ¶¶ 1–26; Ex. 1002 ¶ 60). Patent Owner does not dispute that evidence. Based on the undisputed November 26, 2001 public availability date, the May Thesis represents a disclosure less than one year before the asserted effective filing date, i.e., July 1, 2002. Based on that timing and because the disclosure was made by the inventor, the May Thesis is not available as prior art to the Challenged Claims under 35 U.S.C. §102(b).” slip op. at 11

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableInherency not foundNot shown unpatentable

    “summarized above, we determine that the May Article fails to disclose the restriction sites surrounding the BstXI and SnaBI HS2-, BamHI and HindIII HS3-, or BamHI and BanII HS4-spanning nucleotide fragments, as required by the challenged claims. According to Petitioner, that limitation is inherently disclosed by the May Article’s description of the lengths of the HS2, HS3, and HS4 fragments in the TNS9 vector and its depiction of those fragments on a map of the LCR. Pet. 28. To support its inherency argument, Petitioner relies on knowledge in the art, i.e., the availability of the entire map of the LCR region, and the availability of restriction enzymes, including BstX1, SnaBI, BamHI, HindIII, and BanII. Id. at 39–40 (citing Kennametal, 780 F.3d at 1381–83). Based on that combined information, Petitioner contends that a POSA would “have been able to map all of the possible restriction sites in the regions flanking the cores of HS2, HS3, and HS4.” Id. Petitioner asserts further that “[g]iven the May Article’s disclosure regarding the size and location of TNS9’s HS2, HS3, and HS4 fragments, a POSA would have placed these fragments onto the restrictionsite map of the LCR” that was available at the time, and would have identified only six possible combinations of restriction enzyme fragments, including the one recited in claim 1. Id. Upon closer inspection, however, we appreciate from the testimony of Petitioner’s declarant, Dr. Bungert, that the process involved in arriving at those six possible combinations is predicated on numerous assumptions guiding a number of exacting steps to be performed in order to achieve the the claimed LCR fragment would have involved the steps of (a) placing fragments that are the disclosed size of the HS2, HS3, and HS4 fragments from the TNS9 vector in the May Article onto the known restriction-site map of the LCR; (b) comparing those fragments to the “‘drawn to scale’ map” in the May Article; and then (c) identifying various fragments and determining which ones are consistent with the May Article’s description and match up with the fragments on the May Article’s drawn to scale map. Ex. 1002 ¶¶ 143–156. To identify the fragments consistent with the May Article’s description, it was necessary for Dr. Bungert to use certain assumptions that exclude unfavorable enzymes, such as using a range of ± 20 bp in order to identify fragments with lengths that are within 20 bp of the fragments reported in the May Article. Id. In view of the number of assumptions and steps required to get from what is disclosed in the May Article to arrive at the alleged “six possible LCRs (i.e., combination of HS2, HS3, and HS4 fragments based on the TNS9 LCR disclosed in the May Article)—including the LCR recited in claim 1,” Ex. 1002 ¶ 156, we do not find that Petitioner has demonstrated that fragments having the restriction sites recited in claim 1 would have been “at once envisaged” by a skilled artisan as argued by Petitioner. Pet. 39–40.” slip op. at 16

  Patent outcomesUS 8,058,061 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,058,061
• Bluebird Bio, Inc. v. Sloan Kettering Institute For Cancer ResearchNo claims unpatentable
  PTAB · Apr 22, 2024 · IPR2023-00070 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 1, 10, 19, and 22 were not shown unpatentable because the May Thesis was not prior art and the May Article and May Abstract did not establish the claimed LCR fragments.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner does not dispute Petitioner’s description of the level of ordinary skill in the art. See PO Resp. Because Petitioner’s uncontested definition of one of ordinary skill in the art is reasonable and consistent with the ’179 patent and the prior art of record, we adopt Petitioner’s definition for purposes of this Decision.” slip op. at 8

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

    “Based upon our review of the current record, we determine that no claim terms require express construction for purposes of this Decision. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (Only those terms that are in controversy need be construed, “and only to the extent necessary to resolve the controversy.”).” slip op. at 8

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artNot shown unpatentable

    “the ’179 patent. Id.; Ex. 1004, 3; Ex. 1001, code (75). Thus, the May Thesis represents the work of one of the ’179 inventors and is therefore ineligible as prior art under 35 U.S.C. § 102(a) for challenged claims 1, 19, and 22. See, e.g., In re Katz, 687 F.2d 450, 454–455 (CCPA 1982) (a prior publication by inventors or a subset of the inventors does not qualify as prior art under 102(a)). With respect to 35 U.S.C. § 102(b), we find that the May Thesis is ineligible as prior art, even assuming that claims 1, 19, and 22 are not entitled to receive benefit of an earlier filing date. Petitioner provides evidence that the May Thesis was publicly available as of November 26, 2001. Pet. 17 (citing Ex. 1036 ¶¶ 1–26; Ex. 1002 ¶ 60). Patent Owner does not dispute that evidence. Based on the undisputed November 26, 2001 public availability date, the May Thesis represents a disclosure less than one year before the asserted effective filing date, i.e., the July 1, 2002, for claims 1, 19, and 22 challenged with this reference. Based on that timing and because the disclosure was made by the inventor, the May Thesis is not available as prior art to challenged claims 1, 19, and 22 under 35 U.S.C. §102(b). Petitioner has not established that the May Thesis is prior art to claims” slip op. at 11

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

    “summarized above, we determine that the May Article fails to disclose the restriction sites surrounding the BstXI and SnaBI HS2-, BamHI and HindIII HS3-, or BamHI and BanII HS4-spanning nucleotide fragments, as required by the challenged claims. According to Petitioner, that limitation is inherently disclosed by the May Article’s description of the lengths of the HS2, HS3, and HS4 fragments in the TNS9 vector and its depiction of those fragments on a map of the LCR. Pet. 28. To support its inherency argument, Petitioner relies on knowledge in the art, i.e., the availability of the entire map of the LCR region, and the availability of restriction enzymes, including BstX1, SnaBI, BamHI, HindIII, and BanII. Id. at 30–31 (citing Kennametal, 780 F.3d at 1381–83). Based on that combined information, Petitioner contends that a POSA would “have been able to map all of the possible restriction sites in the regions flanking the cores of HS2, HS3, and HS4.” Id. Petitioner asserts further that “[g]iven the May Article’s disclosure regarding the size and location of [TNS9’s] HS2, HS3, and HS4 fragments, a POSA would have placed these fragments onto the restrictionsite map of the LCR” that was available at the time, and would have identified only six possible combinations of restriction enzyme fragments, including the one recited in claim 1. Id. Upon closer inspection, however, we appreciate from the testimony of Petitioner’s declarant, Dr. Bungert, that the process involved in arriving at those six possible combinations is predicated on numerous assumptions guiding a number of exacting steps to be performed in order to achieve the claimed LCR fragment. According to Dr. Bungert, the process for making the claimed LCR fragment would have involved the steps of (a) placing fragments that are the disclosed size of the HS2, HS3, and HS4 fragments from the TNS9 vector in the May Article onto the known restriction-site map of the LCR; (b) comparing those fragments to the “‘drawn to scale’ map” in the May Article; and then (c) identifying various fragments and determining which ones are consistent with the May Article’s description and match up with the fragments on the May Article’s drawn to scale map. Ex. 1002 ¶¶ 112–117. To identify the fragments consistent with the May Article’s description, it was necessary for Dr. Bungert to use certain assumptions that exclude unfavorable enzymes such as using a range of ± 20 bp in order to identify fragments with lengths that are within 20 bp of the fragments reported in the May Article. Id. In view of the number of assumptions and steps required to get from what is disclosed in the May Article to arrive at the alleged “six possible LCRs (i.e., combination of HS2, HS3, and HS4 fragments based on the TNS9 LCR disclosed in the May Article)—including the LCR recited in claim 1,” Ex. 1002 ¶ 117, we do not find that Petitioner has demonstrated that fragments having the restriction sites recited in claim 1 would have been “at once envisage[d]” by a skilled artisan as argued by Petitioner. Pet. 30–31.” slip op. at 16

  Patent outcomesUS 7,541,179 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 7,541,179
• Stryker Corporation / Wright Medical Technology, Inc v. Osteomed LLCNo claims unpatentable
  PTAB · May 30, 2023 · IPR2022-00191 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 15 and 21 were not shown unpatentable because Slater does not disclose the claimed tensile-load transfer, and Falkner with Duncan lacks the claimed arrangement and adequate motivation to modify.

  RulingsFinal written decision

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

    “hole is configured to direct the transfixation screw on a trajectory that is a fixed angle or is configured to allow for “adjustable orientation” based on “a predetermined allowable angular range” such as opening 26 of Slater, identified by Petitioner as the transfixation screw hole. Pet. 16; Ex. 1005, 12:23–25, 11:21–22. Here, I first note the specification does not describe a plate having a hole identified as a transfixation screw hole that would accommodate insertion of a screw at a plurality of angles through the same hole. Rather, the specification repeatedly describes the disclosed plate system as having a transfixation screw hole where it is the inner surface of that hole that is configured to direct a screw at a trajectory, which, according to Mr. Sommers, is language a person of ordinary skill in the art would understand to describe a degree of precision around a single fixed angle. Ex. 1001, 1:26–45, 2:8–14, 2:42–46; Ex. 2002 ¶¶ 50, 94, 96; PO Resp. 16– 19. For example, the specification describes how “increased plate thickness around transfixation screw hole 102 may also enable transfixation screw hole 102 to be machined into bone plate 100 at an angle relative to the top surface of bone plate 100.” Ex. 1001, 9:8–12 (emphasis added). In other embodiments, the central axis of the inner surface of the transfixation screw hole defines the trajectory. Id. at 1:60–61; 6:41–67. By comparison, other holes in the disclosed plates are not disclosed with the same level of effort specification even includes a description of an oblong opening such as the one found in Slater, described as compression hole 132 and serves the purpose of tightening bones so as to “to press together at the interface of joint 106.” Id. at 9:12–9:46. Taken together, the specification, when read as a whole, describes plates with a transfixation screw hole configured at a single trajectory selected to achieve the functional objectives of the plate, namely, joint fusion, where that single trajectory is preferably between 30 and 70 degrees, and more preferably, 50 degrees. Id. at 6:41–55. Petitioner fails to direct us to any example or other disclosure to support its alternative interpretation, namely, a plate configured with a transfixation screw hole 102 configured to permit the placement of a screw at a plurality of trajectories or angles.” slip op. at 51

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

    “configuration, which relies on Petitioner’s argument that Slater uses a lag screw with threads on its end that only engage the second bone in Slater’s two-bone configuration. See Pet. 26–29; Reply 13–15. We are not persuaded by Petitioner’s argument because Slater does not expressly or inherently disclose how its lag screw threads interact with the first and second bone. Slater’s Figure 4 “shows an elevation view of a second screw type 70” having “a longer shank to increase depth of penetration and has an abbreviated threaded portion to allow the majority of the shank to slide through aligned tibial and talus screw holes finally anchoring in the calcaneus bone.” Ex. 1005, 12:32–13:3. This description of screw type 70 in the three-bone configuration does not state that the screw only engages the third bone, the calcaneus bone, and describes the “majority of the shank” as “slid[ing] through” holes in the first two bones without stating that none of the threads engage a portion of, for example, the end of the second bone adjacent the third bone. See id. More importantly, even if this portion of Slater describes a three-bone embodiment where the threads only engage the third bone, Slater provides insufficient support for Petitioner’s position that the threads of screw type 70 only engage the second bone in Slater’s two-bone embodiment, which Petitioner relies on as the anticipatory embodiment of Slater. See Pet. 21; Ex. 1002 ¶ 108 (arguing that Slater’s Figure 1 shows two-bone embodiment). Slater contains no details on this aspect of its alternative two-bone embodiment, such that the threads of the screw may engage the end of the first bone adjacent the second bone and still provide satisfactory results. At best, Petitioner and Dr. Gall’s related testimony establish that it would have been desirable, and perhaps obvious, to have the threads of screw type 70 only engage the second bone in Slater’s two-bone embodiment to create a vise-like configuration that transfers tensile load as claimed, but that does not establish that Slater expressly or inherently discloses such an embodiment to satisfy the anticipation standard.” slip op. at 25

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

    “Falkner’s single-bone embodiment (e.g., as shown in Figures 1 and 2) by citing various other teachings in Falkner, we see minimal analysis that explains why the POSA would have been motivated to make those modifications with a reasonable expectation of success to arrive at claim 10’s subject matter. Even when only one reference is involved, the mere fact that each claim limitation might be found in such reference’s disclosure does not necessarily prove obviousness without analysis that explains why the skilled artisan would have combined those teachings to arrive at the claimed subject matter. In re Stepan, 868 F.3d 1342, 1345–46 n.1 (Fed. Cir. 2017) (“Whether a rejection is based on combining disclosures from multiple references, combining multiple embodiments from a single reference, or selecting from large lists of elements in a single reference, there must be a motivation to make the combination and a reasonable expectation that such a combination would be successful, otherwise a skilled artisan would not arrive at the claimed combination.”) (emphasis added). We recognize that Falkner discloses that its plates may be designed to traverse a joint between bones. See, e.g., Ex. 1006 ¶¶ 21, 23, 29. But there is a dearth of detail about such a hypothetical plate’s actual design. On this record, it appears to us that making such a plate or modifying the plate of Figure 1 to render it suitable to, for example, spanning a joint between the tibia and talus, would require the person of ordinary skill in the art to make distinct design choices beyond any embodiment explicitly described in Falkner. Even then, it is not a foregone conclusion that all the claim limitations would be met (e.g., surfaces of the first and second ends that conform to a bone geometry, and a thicker bridge portion relative to the ends). Petitioner provides minimal argument and evidentiary support to explain why all the claimed features would be included. Petitioner argues, for example, that Falkner’s Figure 1 shows a portion of a transfixation screw hole that has a depth greater than a portion of the plate’s first and second ends. Pet. 41–43. What Petitioner identifies, however, is not the screw hole but the head of a screw. Id. at 42 (hashed red-circle). Neither the identified bridge portion nor screw hole itself appears to have a depth greater than the plate’s first end—claim 10 recites that the depth be greater than a portion of the first and second ends. Petitioner briefly remarks that Falkner “contemplates reducing the [plate] thickness of the bone plate to minimize irritation of soft tissue in regions such as the ‘first end’ of the plate.” Id. (citing Ex. 1006 ¶¶ 32, 35; Ex. 1002 ¶¶ 151, 174). But, on this record, whether Falkner’s cited disclosures teach or suggest that the plate’s first end, in particular, should be made thinner than the bridge and screw hole portions lacks clarity; and Petitioner does very little to explain why a POSA would have been motivated to decrease the thickness at that specific part of the plate.” slip op. at 41

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner

    “Finally, for similar reasons, we find the testimony of Patent Owner’s declarant Mr. Sommers more credible and persuasive than the testimony of Petitioner’s declarant Dr. Gall. For example, Dr. Gall opines that Slater discloses a vise configuration, but fails to point to any portion of Slater disclosing that configuration with respect to the two-bone embodiment. See Ex. 1002 ¶ 117; Ex. 1027 ¶¶ 33–46. Again, this testimony may establish the desirability of such a configuration and that one of ordinary skill in the art, when using Slater’s plate, may do so in the manner Dr. Gall proposes, but that does not establish that Slater expressly or inherently discloses a vise-like configuration due to threaded engagement with only the second bone in Slater’s two-bone embodiment. We view the testimony of Mr. Sommers as more credible because it more accurately tracks Slater’s disclosures. See Ex. 2002 ¶¶ 81–82 (opining that Slater “does not describe whether there would also be threads” in the second of the three bones in the three-bone embodiment, in practice the threads may engage multiple bones, and Slater does not illustrate or describe how the screw would be used on a two-bone configuration), 75, 105–116 (opining that Slater fails to disclose the transfer of tensile load limitations).8” slip op. at 27

  Patent outcomesUS 9,763,716 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness
  Patents in suitUS 9,763,716
• Stryker Corporation / Wright Medical Technology, Inc. v. Osteomed LLCNo claims unpatentable
  PTAB · May 30, 2023 · IPR2022-00190 · APJ Sheridan K Snedden · IPR · Final written decision

  The Board found claim 15 not unpatentable: Slater did not anticipate it, and Petitioner did not show it obvious over Falkner and Duncan.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner

    “Finally, for similar reasons, we find the testimony of Patent Owner’s declarant Mr. Sommers more credible and persuasive than the testimony of Petitioner’s declarant Dr. Gall. For example, Dr. Gall opines that Slater discloses a vise configuration, but fails to point to any portion of Slater disclosing that configuration with respect to the two-bone embodiment. See Ex. 1002 ¶ 112; Ex. 1027 ¶¶ 37–46. Again, this testimony may establish the desirability of such a configuration and that one of ordinary skill in the art, when using Slater’s plate, may do so in the manner Dr. Gall proposes, but that does not establish that Slater expressly or inherently discloses a vise-like configuration due to threaded engagement with only the second bone in Slater’s two-bone embodiment. We view the testimony of Mr. Sommers as more credible because it more accurately tracks Slater’s disclosures. See Ex. 2002 ¶¶ 57–58 (opining that Slater “does not describe whether there would also be threads” in the second of the three bones in the three-bone embodiment, in practice the threads may engage multiple bones, and Slater does not illustrate or describe how the screw would be used on a two-bone configuration), 81–83, 108–120 (opining that Slater fails to disclose the transfer of tensile load limitations).2” slip op. at 24

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “art references themselves. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995). Petitioner proposes that a person of ordinary skill in the art (“POSA” or “POSITA”) at the time of the invention would be an individual having at least a bachelor’s degree in engineering with at least two years of experience in the field, such as experience with the design of surgical implants, or a clinical practitioner with a medical degree and at least two years of experience as an orthopedic surgeon. Pet. 13 (citing Ex. 1002 ¶¶ 35–39). Patent Owner does not dispute Petitioner’s proposal about the POSA’s qualifications. PO Resp. 22. For this Decision, we adopt and apply Petitioner’s proposal for the POSA level, which does not appear to be inconsistent with the level of skill reflected in the asserted prior art.” slip op. at 9

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

    “screw with threads on its end that only engage the second bone in Slater’s two-bone configuration. See Pet. 26–29 (citing Ex. 1002 ¶ 112; Ex. 1005, 11:19–25, 12:32–13:3, 13:21–24); Pet. Reply 13–15 (citing Ex. 1002 ¶ 112; Ex. 1005, 5:28–6:10, 6:18–28, 12:32–13:3, 19:25–26, 22:13–18, 27:11–17; Ex. 1027 ¶¶ 121–123; Ex. 1027 ¶¶ 33–42; Ex. 1031, 67:23–68:7, 68:17– 70:3, 70:16–19, 71:5–9, 74:6–25, 75:5–13, 77:14–22, 106:19–107:17; Ex. 2003, 46:23–48:4, 90:24–91:23). We are not persuaded by Petitioner’s argument because Slater does not expressly or inherently disclose how its lag screw threads interact with the first and second bone. Slater’s Figure 4 “shows an elevation view of a second screw type 70” having “a longer shank to increase depth of penetration and has an abbreviated threaded portion to allow the majority of the shank to slide through aligned tibial and talus screw holes finally anchoring in the calcaneus bone.” Ex. 1005, 12:32–13:3. This description of screw type 70 in the three-bone configuration does not state that the screw only engages the third bone, the calcaneus bone, and describes the “majority of the shank” as “slid[ing] through” holes in the first two bones without stating that none of the threads engage a portion of, for example, the end of the second bone adjacent the third bone. See id. More importantly, even if this portion of Slater describes a three-bone embodiment where the threads only engage the third bone, Slater provides insufficient support for Petitioner’s position that the threads of screw type 70 only engage the second bone in Slater’s two-bone embodiment, which Petitioner relies on as the anticipatory embodiment of Slater. See Pet. 27– 28; Ex. 1002 ¶¶ 111–112 (arguing that Slater’s Figure 1 shows two-bone embodiment). Slater contains no details on this aspect of its alternative twobone embodiment, such that the threads of the screw may engage the end of the first bone adjacent the second bone and still provide satisfactory results. At best, Petitioner and Dr. Gall’s related testimony establish that it would have been desirable, and perhaps obvious, to have the threads of screw type 70 only engage the second bone in Slater’s two-bone embodiment to create a vise-like configuration that transfers tensile load as claimed, but that does not establish that Slater expressly or inherently discloses such an embodiment to satisfy the anticipation standard.” slip op. at 22

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

    “Moreover, to the extent Petitioner’s challenge purports to modify Falkner’s single-bone embodiment (e.g., as shown in Figures 1 and 2) by citing various other teachings in Falkner, we see minimal analysis that explains why the POSA would have been motivated to make those modifications with a reasonable expectation of success to arrive at claim 10’s subject matter. Even when only one reference is involved, the mere fact that each claim limitation might be found in such reference’s disclosure does not necessarily prove obviousness without analysis that explains why the skilled artisan would have combined those teachings to arrive at the claimed subject matter. In re Stepan Co., 868 F.3d 1342, 1345–46 n.1 (Fed. Cir. 2017) (“Whether a rejection is based on combining disclosures from multiple references, combining multiple embodiments from a single reference, or selecting from large lists of elements in a single reference, there must be a motivation to make the combination and a reasonable expectation that such a combination would be successful, otherwise a skilled artisan would not arrive at the claimed combination.”) (emphasis added). Falkner’s cited plate in Figures 1 and 2 is not arranged as claimed. Ex. 1006, Fig. 1. It is not configured to secure two discrete bones (e.g., the tibia and talus) across an intermediate joint between those bones, nor is the plate configured with first and second ends having inner surfaces that substantially conform with a geometry of first and second discrete bones. This is plain from the cross-sectional anatomical views of the tibia, joint, and talus shown in the figure itself. To make the plate so configured would seemingly require redesign or modifications. Petitioner’s obviousness analysis on claim 10 is, however, wanting for detail as noted above (e.g., minimal explanation why the POSA would have modified the Falkner plate with a reasonable expectation of success). We recognize that Falkner discloses that its plates may be designed to traverse a joint between bones, including the ankle joint. See, e.g., Ex. 1006 ¶¶ 21, 23, 29. But there is a dearth of detail about such a hypothetical plate’s actual design. On this record, it appears to us that making such a plate or modifying the plate of Figure 1 to render it suitable to, for example, spanning a joint between the tibia and talus would require the person of ordinary skill in the art to make distinct design choices beyond any embodiment explicitly described in Falkner. Even then, it is not a foregone conclusion that all the claim limitations would be met (e.g., surfaces of the first and second ends that conform to a bone geometry, and a thicker bridge and screw hole portion relative to the ends), and Petitioner provides minimal argument and evidentiary support to explain why all the claimed features would be included. Petitioner argues, for example, that Falkner’s Figure 1 shows a portion of a transfixation screw hole that has a depth greater than a portion of the plate’s first and second ends. Pet. 40–42. What Petitioner identifies, however, is not the screw hole but the head of a screw. Id. at 42 (hashed red-circle). Neither the identified bridge portion nor screw hole itself appears to have a depth greater than the plate’s first end—claim 10 recites that the depth be greater than a portion of the first and second ends. Petitioner briefly remarks that Falkner “contemplates reducing the [plate] thickness of the bone plate to minimize irritation of soft tissue in regions such as the ‘first end’ of the plate.” Id. at 41 (citing Ex. 1006 ¶¶ 32, 35; Ex. 1002 ¶ 133). But, on this record, whether Falkner’s cited disclosures teach or suggest that the plate’s first end, in particular, should be made thinner than the bridge and screw hole portions lacks clarity; and Petitioner does very little to explain why a POSA would have been motivated to decrease the thickness at that specific part of the plate.” slip op. at 40

  Patent outcomesUS 9,351,776 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness
  Patents in suitUS 9,351,776

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.