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  • PTAB · Feb 17, 2026 · IPR2024-01261 · APJ Jamie T Wisz · IPR · Final written decision

    Claims 1–20 were not shown unpatentable because the asserted combinations did not teach the claimed predetermined cycle for controlling distal fluid flow.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “(1) a person with a B.S. in engineering or an equivalent field, with two-four years of academic or industry experience in aspiration embolectomy and thrombectomy or comparable industry experience who would, where appropriate, work or consult with others, including a physician, to develop embolectomy or thrombectomy devices; or (2) an interventional neurosurgeon with at least three years of experience developing and/or using medical devices in embolectomy or thrombectomy procedures, and who would, where appropriate, work or consult with others, including an engineer, to develop such a medical device. Pet. 11 (citing Ex. 1005 ¶ 48). Petitioner also contends that, “[a] person with less education but more relevant practical experience, or more relevant education but less practical experience, may also meet this standard.” Id. Patent Owner states that for purposes of its PO Response, it “accepts ¶ 44). We adopt Petitioner’s characterization because it is consistent with the level of skill in the art at the time of the invention as reflected by the ’402 patent and the cited prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 8

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

      “specification explicitly includes sensors similar to those in the prior art in support of their argument that the claimed “predetermined cycle” must not exclude the use of such sensors. Pet. Reply 15 (citing Ex. 1001, 32:55–33:7, 40:66–41:5, 44:9–29). We reviewed the portions of the specification cited by Petitioner. We agree with Patent Owner that one excerpt discussing sensor use appears to be directed to triggering the predetermined cycle rather than causing timing changes during the cycle itself (Ex. 1001, 32:55–66) (describing use of a pressure sensor to “determine when the vacuum channel 3 is clogged by a thrombus and automatically perform the unclogging procedures described herein”), while another excerpt discusses a sensor that Petitioner that the ’402 patent discusses the use of sensors to “tune” the system and that such “tuning” can be done statically (setting the cycle timing in advance) or dynamically (adjusting the timing during the cycle itself). See Ex. 1001, 48:19–49:50. Overall, we find that these disclosures involving sensors demonstrate that sensors may be used in various ways in different embodiments. However, none of these disclosures explicitly discuss the use of sensors in conjunction with a “pre-determined cycle.” Therefore, we find that the ’402 patent specification’s discussion of “sensors” are not particularly informative as to the appropriate construction of a “predetermined cycle” and do not outweigh the other explicit disclosures of “predetermined cycle” in the patent. We next turn to the other intrinsic evidence discussed by the parties — the prosecution history. As discussed by Patent Owner, in the Notice of Allowance, the Examiner found that Garrison did not teach or suggest a “predetermined cycle” because Garrison’s controller “changed the cycle of opening and closing the valves based on feedback from sensors.” Ex. 1004, 86. We acknowledge that the patent applicant filed subsequent comments during prosecution in which they stated that they “do[] not concede that the Examiner’s characterizations of the terms of the claims and the prior art are correct.” Id. at 29. However, we agree with Patent Owner that the importance of the Examiner’s statement in the Notice of Allowance does not rely on it being an express disclaimer (a standard which it does not meet). PO Sur-reply 8. We also considered Petitioner’s contention that the Examiner’s interpretation of Garrison may have been in error (PO Resp. 16); however, even if this were true, the Examiner’s statement still provides helpful insight into how the Examiner was interpreting the term sensors to change the opening and closing of valves during a cycle was not a “predetermined cycle.” Id. at 86. In sum, we find that Patent Owner’s proposed construction is consistent with the usage of the term “predetermined cycle” in the ’402 patent specification and prosecution history. Thus, after considering all of the cited evidence, we construe “predetermined cycle” to mean that “the timing of the sequence of valve operations in the cycle is determined beforehand, i.e., fixed, rather than varying based on feedback after operation begins.”” slip op. at 14

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

      “2. Other Terms The parties also provided proposed constructions for the limitations of “[limited/limiting] to a positive amount of exit flow” and “control[ling] fluid flow in and out from the distal end of the catheter.” See Pet. 15–16; Pet. Reply 1–8; PO Resp. 22–24; PO Sur-Reply 2–6. However, having evaluated the arguments and evidence before us, we determine that construction of these terms is not necessary for purposes of this Decision. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”)).” slip op. at 16

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableNot shown unpatentable

      “We agree with Patent Owner that neither Petitioner nor Mr. Brown propose any combination of Yang and Mullins that does not include Mullins’s pressure sensor in order “to control fluid flow in and out from the distal end of the catheter.” Indeed, in addressing the “predetermined cycle” limitation, Mr. Brown contends that Mullins discloses a “cycling controller that ‘varies aspiration pressure according to sensed pressure within the catheter lumen.’” Ex.1005 ¶¶ 131–32 (citing, e.g., Ex.1008, 27:40–28:20 (“[a] novel aspect of this pump system is the incorporation of feedback into the pump algorithm in order to produce more effective pressure cycling”)). This use of a sensor to change pressure during a cycle, is not a “predetermined cycle” under our construction. combinations is its discussion of distal end flow control, not for its sensors.” Pet. Reply 17 (citing Ex. 1035 ¶ 83). However, Petitioner’s obviousness grounds rely on the combination of Yang and Mullins, especially with regard to Mullins’s disclosure of “a controller” in order “to control fluid flow in and out.” As discussed above, Mullins relies on the sensor-feedback approach in order to control flow and we find that Petitioner has not presented persuasive evidence of how the combined disclosures of Yang and Mullins would control flow without using Mullins’s sensor feedback approach. See W.L. Gore & Assocs., Inc. v. Garlock, Inc., 721 F.2d 1540, 1550 (Fed. Cir. 1983) (error to “consider[] … references in less than their entireties, i.e., in disregarding disclosures in [them] … that diverge from and teach away from the invention”). Therefore, we determine that Petitioner has not sufficiently shown that the combination of Yang and Mullins discloses or renders obvious “a controller configured to open and close the vacuum valve and the vent valve in a predetermined cycle to change a level of vacuum at the distal end of the catheter and to control fluid flow in and out from the distal end of the catheter.” Accordingly, having considered the parties’ respective evidence and arguments, we find that Petitioner has not shown by a preponderance of the evidence that claim 1 of the ’402 patent would have been unpatentable as obvious over the combination of Yang and Mullins.” slip op. at 27

    Patent outcomesUS 11,406,402 not shown unpatentable
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 11,406,402
  • PTAB · Feb 2, 2026 · IPR2024-01467 · APJ David Cotta · IPR · Final written decision

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

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

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

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

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

    • Expert testimonyPetitioner expert discountedDecided for patent owner

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

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

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

    Patent outcomesUS 11,906,508 not shown unpatentable
    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,906,508
  • PTAB · Mar 18, 2025 · IPR2023-01383 · APJ Kimberly Mcgraw · IPR · Final written decision

    Claims 1–5 were not shown unpatentable because Petitioner did not sufficiently establish a reason to modify the asserted prior art.

    RulingsFinal written decision
    • Expert testimonyPatent owner expert creditedDecided for patent owner

      “We disagree with Petitioner’s argument because it fails to address Dr. Schubert’s academic and other experience with GaN transistors. Dr. Schubert is currently a tenured full professor in the Department of Electrical Computer, and Systems Engineering at Rensselaer Polytechnic Institute and was previously a tenured full professor in the Department of Electrical and Computer Engineering at Boston University. Ex. 2001, 129. Additionally, Dr. Schubert was the director of Boston University’s Semiconductor Devices Research Laboratory. Ex. 2001, 129. Dr. Schubert persuasively explains that his general expertise is in the field of electrical engineering and applied physics, including semiconductors, processing, and devices and his specific expertise is in the field of semiconductor materials (such as GaN), semiconductor devices, semiconductor integrated circuits, ohmic contacts, Schottky contacts, HEMTs, and optoelectronic devices such as light-emitting diodes (LEDs). Ex. 2001 ¶ 11, App’x A pp.129–137. His experience includes “the design, growth, fabrication, and testing of semiconductor devices as well as the employment of these devices in a variety of applications” and he is “familiar with both the design of such transistors [HEMTs] and the manufacturing processes used for FETs. Ex. 2001 ¶ 11, App’x A, pp. 129–137. He is an author or co-author of numerous text books and articles, and co-inventor of numerous patents, including those dealing with HEMT transistors and GaN devices. Ex. 2001 ¶ 13, App’x A, pp. 129–137. Petitioner fails to present any persuasive argument or evidence that Dr. Schubert’s extensive education and experience regarding GaN transistors is insufficient or lacking such that his testimony should be given little weight. Finally, we disagree with Petitioner’s additional argument that that its expert’s testimony (Dr. Shealy) should be given more weight than Patent Owner’s expert’s testimony (Dr. Schubert) because “[u]nlike Dr. Schubert, Dr. Shealy is one of the pioneer scientists in the field of GaN transistors.” Reply 34 (stating that Dr. Shealy’s research lab built the first GaN HEMT device on silicon in 1999 and citing Ex. 2002, 87:19–238). Obviousness is determined through the lens of a “person of ordinary skill in the art,” not through the lens of a person with extraordinary skill or a pioneer in the field. Given Dr. Schubert’s extensive relevant education and experience, Petitioner does not persuasively explain why Dr. Shealy’s testimony on any specific topic, or his testimony in general, should be given more weight than Dr. Schubert’s.” slip op. at 16

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “understanding of a person of ordinary skill in the art (sometimes abbreviated herein as “POSITA”). Graham, , 383 U.S. at 17–18. Petitioner argued that a person of ordinary skill in the art would have had a “at least a four-year degree in electrical engineering, chemical engineering, physics, or material science or a closely related field and at least two years of experience in semiconductor device design or fabrication, including the processing of semiconductor materials, analysis of device operation, or the development of new device topologies. Additional education could substitute for professional experience and vice versa.” Pet. 11 (citing Ex 1003 ¶ 69). Patent Owner did not dispute this proposed definition prior to institution. See generally Prelim. Resp. In our Decision on Institution, we adopted Petitioner’s proposal. After institution, Patent Owner asserted a slightly different definition of a POSITA, namely someone who “would have possessed at least a four-year degree in electrical engineering, physics, material science, or a closely related field, and three years of professional work experience in the epitaxial growth, design, and fabrication of semiconductor electronic devices, including those of GaN.” Resp. 17. Relevant graduate education could substitute for the professional work experience. Id. Upon review of the full record, we see no reason to modify, and we thus maintain, the definition of a POSITA applied in our Decision on Institution. We also determine that our decision would be the same under either of the parties’ proposed definitions.” slip op. at 14

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Not reached

      “During the proceeding, the parties also dispute the proper construction of “etching away the doped GaN layer, except a portion of the doped GaN layer beneath the gate contact” as recited in step [1e4] and provided briefing on this issue. Papers 35, 36, 37, 38. Because, as explained below, our determination rests upon Petitioner’s failure to show a sufficient reason to modify the asserted art, which is not dependent upon any particular claim construction, we need not, and do not, address these claim construction issues. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)) (holding that only claim terms in controversy need to be construed, and only to the extent necessary to resolve the controversy).” slip op. at 13

    • ExcludeDenied

      “III. PETITIONER’S MOTION TO EXCLUDE EXHIBIT 2008 Petitioner filed a Motion to Exclude (Paper 25, “Mot.”) Exhibit 2008, which is a hearing transcript from the parallel ITC investigation. Mot. 1. Because we do not rely upon Exhibit 2008 in our Decision, we dismiss Petitioner’s motion as moot.” slip op. at 47

    Patent outcomesUS 8,404,508 not shown unpatentable
    Claim construction§ 103 obviousnesscites Phillips · KSR
    Patents in suitUS 8,404,508
  • Intel Corporation v. Besang Inc.No claims unpatentable
    PTAB · Dec 11, 2024 · IPR2023-00991 · APJ Jon B Tornquist · IPR · Final written decision

    The Board held claims 1 and 13–17 not unpatentable, finding the asserted obviousness grounds deficient in claim limitations or motivation to combine.

    RulingsFinal written decision
    • Skill levelSkill level patent owner adoptedDecided for patent owner

      “The parties proposed definitions differ in that Petitioner would permit a degree in “materials science” and require three years, as opposed to two years, of relevant experience. Compare Pet. 9 with PO Resp. 14. On this record, we adopt Patent Owner’s proposed definition, as it is more consistent with the prior art of record and the disclosures of the ’702 patent. We note, however, that neither party contends that the outcome of this case depends on the slight differences in the proposed definitions of a person of ordinary skill in the art.” slip op. at 9

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

      “1996) (“It is well-settled that, in interpreting an asserted claim, the court should look first to the intrinsic evidence of record, i.e., the patent itself, including the claims, the specification and, if in evidence, the prosecution history.”). Upon review of the parties’ arguments and the intrinsic record, we agree with Petitioner that the ’702 patent does not support a construction of “stackable add-on layer” that encompasses memory cells formed by sequential deposition on a substrate without being formed and then added to a separately formed substrate. Pet. 11–12. First, the plain language of the claim does not require merely a “layer” having a plurality of vertically oriented semiconductor memory cells, but rather “a stackable add-on layer” having a plurality of vertically oriented semiconductor memory cells; that plurality is bonded to the dielectric layer. Ex. 1001, 12:29–32. A construction that gives meaning to all words of the claim is preferred. Merck & Co., Inc. v. Teva Pharm. USA, Inc., 395 F.3d 1364, 1372 (Fed. Cir. 2005) (“A claim construction that gives meaning to all the terms of the claim is preferred over one that does not do so.”).” slip op. at 12

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

      “As discussed above, we do not understand a “stackable add-on layer” to include memory cells that are formed by sequential deposition on or above a substrate without being added to a separately formed substrate. It is undisputed, and indeed it is Petitioner’s assertion, that Lee’s memory devices are formed by sequential deposition. Pet. 16, 29 n.11, 51 (“In Lee, each level 3104 is deposited on the underlying level of array 3101.”). Therefore, Petitioner has not shown that Lee discloses every limitation of independent claim 13 under our claim construction. Thus, Petitioner does not demonstrate by a preponderance of the evidence that claim 13 would have been obvious in view of Lee. 3. Analysis: Claims 14–17 Claims 14–17 each depend, directly or indirectly, from claim 13. Petitioner’s arguments with respect to these claims do not remedy the deficiencies noted above with respect to claim 13. Pet. 31–41. Accordingly, Petitioner does not demonstrate by a preponderance of the evidence that claims 14–17 would have been obvious over Lee.” slip op. at 19

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

      “We agree with Patent Owner that Petitioner has not demonstrated that Aspar would improve Lee, would solve a problem in Lee, and that Petitioner is proposing to use Aspar in a way that is not disclosed in the reference. PO Resp. 49–50 (citing Ex. 2029 ¶¶ 153–162); Tr. 57:24–58:12; Pet. 61; KSR, 550 U.S. at 417 (asking whether a technique “would improve similar devices in the same way”), 420 (asking whether there was a known problem in the art), 421 (asking whether one of ordinary skill in the art had reason to “pursue the known options”); Intel, 61 F.4th at 1381 (explaining that obviousness may be demonstrated by showing that there was a known problem in the art (“cache coherency in multiprocessor systems”) and that a person of ordinary skill in the art would recognize that that the prior art solution to this problem (“global segmented secondary cache”) would improve the system of another prior art reference). Petitioner does not persuasively show that there was any known problem in the art with respect to Lee or its monolithic method of constructing memory arrays. Nor does Petitioner provide persuasive argument or evidence that Aspar’s wafer bonding would improve Lee’s memory device.10 For example, Petitioner states in a conclusory fashion that Aspar would address the known problem of “fabricating 3D structures,” but does not explain what those problems were or why Lee fails to solve them. Pet. 61. Dr. Sechen’s testimony merely parrots the Petition, providing no further analysis or explanation of what problem might exist in Lee when fabricating its 3D structures. Ex. 1003 ¶ 212. The Petition notes that Aspar transfers “thin layers of very good thickness homogeneity and with a high crystalline quality,” but the Petition never asserts that Lee’s direct deposition method fails to provide these same or similar qualities. Pet. 60–61.” slip op. at 27

    Patent outcomesUS 7,378,702 not shown unpatentable
    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 7,378,702
  • PTAB · Nov 13, 2024 · IPR2023-00900 · APJ Jon B Tornquist · IPR · Final written decision

    Claims 13–17 were not shown unpatentable: Lee-based grounds fail on the stackable add-on layer limitation, and Watanabe-based grounds fail on nonvolatile memory, enablement, or motivation to combine.

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

      “meaning in the art. See Irdeto Access, Inc. v. Echostar Satellite Corp., 383 F.3d 1295, 1300 (Fed. Cir. 2004) (stating that, absent an accepted meaning in the art, “we construe a claim term only as broadly as provided for by the patent itself”). Thus, we must attempt to discern the meaning of this term from the claim language itself and from the remainder of the intrinsic record. See Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996) (“It is well-settled that, in interpreting an asserted claim, the court should look first to the intrinsic evidence of record, i.e., the patent itself, including the claims, the specification and, if in evidence, the prosecution history.”). Upon review of the parties’ arguments and the intrinsic record, we agree with Petitioner that the ’702 patent does not support a construction of “stackable add-on layer” that encompasses memory cells formed by sequential deposition on a substrate without being formed and then added to a separately formed substrate.” slip op. at 10

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

      “As discussed above, we construe “stackable add-on layer” to not include memory cells that are formed by sequential deposition on or above a substrate without being added to a separately formed substrate. It is undisputed, and indeed it is Petitioner’s assertion, that Lee’s memory devices are formed by sequential deposition. See Pet. 52 (asserting that in Lee “the layers of the array are directly deposited on the layers of each underlying level, and the array is deposited on the interlayer insulating layer formed over a substrate”); see also id. at 70 (“Lee discloses forming vertical memory devices through layer-by-layer sequential deposition on the substrate . . . .”). Therefore, Petitioner does not show that Lee discloses every limitation of independent claim 13 under our claim construction. Thus, Petitioner does not demonstrate by a preponderance of the evidence that claim 13 would have been obvious in view of Lee. 3. Claims 14 and 15 Claims 14 and 15 depend from claim 13. Ex. 1001, 12:35–42. Petitioner’s arguments for these claims do not remedy the deficiencies noted above with respect to independent claim 13. Pet. 54–59. Accordingly, Petitioner does not demonstrate by a preponderance of the evidence that claims 14 and 15 would have been obvious in view of Lee alone. E. Claims 16 and 17 over Lee and Endoh Petitioner contends the subject matter of claims 16 and 17 would have been obvious over the combined disclosures of Lee and Endoh. Pet. 59–69. Petitioner’s arguments with respect to these claims, however, do not remedy the deficiencies noted above with respect to Lee and its monolithic, sequentially deposited memory array. Accordingly, Petitioner does not demonstrate by a preponderance of the evidence that claims 16 and 17 would have been obvious over Lee and Endoh.” slip op. at 18

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

      “combined Lee and Watanabe to achieve improved integration density. Pet. 71. Petitioner concedes, however, that the benefits of Lee’s design related to 3-D integration and improved integration density would be obtained if Lee’s memory structures are formed using either Lee’s monolithic construction method or Watanabe’s alternative stacking method. Pet. Reply 13–14 (citing Ex. 1041 ¶ 34). Thus, we are not persuaded that improved integration density provides a sufficient rationale for Petitioner’s combination of Lee’s memory device and Watanabe’s stacking method. Petitioner argues that Watanabe’s stacking method “improves the accuracy of the wiring” because the wiring is made “for each planar member.” Pet. 72 (citing Ex. 1005, 6:1–3). Watanabe also states that its disclosed methods provide “a low interconnection wire resistance.” Ex. 1005, 6:20–23. Petitioner does not, however, explain sufficiently how Watanabe’s stacking method would improve Lee’s device. For example, Petitioner does not address whether the alleged wiring benefit already existed in Lee’s monolithic array or explain how this benefit would also apply to Lee’s particular memory array, which differs in construction and elements from Watanabe’s device. This diminishes Petitioner’s benefits-based motivation to combine arguments. In general, a petitioner need not demonstrate that a particular alternate method would improve a prior art device in order to show a motivation to combine. Intel Corp. v. PACT XPP Schweiz AG, 61 F.4th 1373, 1380–81 (Fed. Cir. 2023); see Pet. Reply 20 (citing Intel). But here, Petitioner affirmatively invokes improvement of Lee’s device as a reason for the combination, and we must evaluate Petitioner’s contention. Moreover, any relative lack of improvement or benefits must be weighed against any problems the alternative method would introduce. See Intel Corp. v. Qualcomm Inc., 21 F.4th 784, 795–96 (Fed. Cir. 2021) (noting that simultaneous advantages and disadvantages to a proposed combination must be analyzed to determine whether the disadvantages “outweighed any reason to combine”). Here, as discussed above in more detail with respect to the ground based on Watanabe, the evidence shows that one of ordinary skill in the art would have expected Watanabe’s bonding temperature of 900– 1000° C to damage the electronic devices in an underlying substrate. Ex. 2029 ¶¶ 75–76; Ex. 2028, 123:13–124:7; Ex. 2027, 715. The expected damage to Lee’s device, when balanced against the limited evidence of a benefit to the combination,7 outweighs the reason to combine Lee and Watanabe set forth in the Petition. Accordingly, Petitioner does not demonstrate by a preponderance of the evidence that claim 13 would have been obvious over Lee and Watanabe. 2. Analysis – Claims 14 and 15 Claims 14 and 15 both depend directly from independent claim 13. Ex. 1001, 12:35–42. Petitioner’s arguments with respect to claims 14 and 15 do not remedy the deficiencies noted above with respect to independent claim 13. Pet. 73. Accordingly, Petitioner does not demonstrate by a preponderance of the evidence that these claims would have been obvious over Lee and Watanabe.” slip op. at 40

    • Expert testimonyPatent owner expert creditedOther

      “We credit the testimony of Dr. Przybylski that one of ordinary skill in the art would have understood that Watanabe’s stacked structure would be severely impacted if bonded at a temperature above 900° C, as disclosed in Watanabe. Ex. 2029 ¶¶ 76–77. Dr. Przybylski’s opinion is supported by Dr. Lee’s testimony (Ex. 2028, 123:13–124:7, 125:6–126:7), as well as Watanabe (Ex. 1005, 6:6–14) and Batude (Ex. 2027, 715). As further discussed below, we find that Petitioner has not rebutted Patent Owner’s showing of nonenablement, and Patent Owner has carried its burden to demonstrate that Watanabe was not enabled for bonding temperatures of 900–1000° C, as of the 2004 filing date of the ’702 patent.” slip op. at 32

    Patent outcomesUS 7,378,702 not shown unpatentable
    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 7,378,702
  • PTAB · May 25, 2023 · IPR2022-00101 · APJ Scott Raevsky · IPR · Final written decision

    Claims 1–7, 11, 12, and 14 were not shown unpatentable: the asserted obviousness combinations failed to establish required LED voltage matching or a clear, workable combination.

    RulingsFinal written decision
    • Skill levelSkill level patent owner adoptedDecided for patent owner

      “We are persuaded that Patent Owner’s proposal is more consistent with the problems and solutions in the ’583 patent and prior art of record. We agree that Petitioner’s proposal is overbroad in that it encompasses artisans without LED circuit design experience (“and two or more years of experience with LED devices and/or related circuit design . . .” (emphasis added)). Patent Owner’s definition, in contrast, requires “two or more years of experience with LED devices and related LED circuit design.” We therefore adopt Patent Owner’s definition of the level of skill, but we note that the outcome here would not have changed had we adopted Petitioner’s level of skill.” slip op. at 7

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

      “preliminarily agreed with Patent Owner that “substrate” may mean “a surface where ‘LEDs, capacitors and/or resistors are formed or mounted.’” Pet. 7; Dec. 19 (quoting Prelim. Resp. 22). We instructed the parties to address the meaning of “substrate” more fully at trial. Dec. 19–20 n.13. Post-institution, the parties propose the following competing constructions for the term “substrate”:” slip op. at 8

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

      “(2) Our analysis We agree with Patent Owner. Patent Owner’s plain reading of limitation 1(c) is correct, and under this reading, the combination of Shackle and Birrell fails to disclose or suggest limitation 1(c). Limitation 1(c) states in part: “at least one LED circuit having any number of LEDs . . . needed to approximately match the forward voltage drop of a first input voltage to the LED driver.” Ex. 1001, 27:22–25 (emphasis added). We have omitted the language “connected in series or series parallel” to highlight the grammatical relationship between the noun phrase “any number of LEDs” and the verb phrase “needed to approximately match.” The plain reading of this limitation is that the at least one LED circuit has any number of LEDs needed to approximately match the forward voltage drop of the LED driver input. Petitioner’s reading, that “the at least one LED circuit,” rather than “any number of LEDs,” must approximately match the forward voltage drop of the LED driver input, is strained and not grammatically plausible. See Reply 1–3. Petitioner does not assert there is an express disclaimer or disavowal in the specification that supports its position; Petitioner instead relies on examples disclosed in the specification to support its faulty interpretation of limitation 1(c). See Reply 2–3. These arguments are unpersuasive. It is axiomatic that we must not “limit[] the claimed invention to preferred embodiments or specific examples in the specification.” Williamson v. Citrix Online, LLC, 792 F.3d 1339, 1346–47 (Fed. Cir. 2015). Not only that, but Petitioner’s citations to the specification better support Patent Owner’s position. In Petitioner’s view, the specification requires other non- LED components to be combined with one or more LEDs to “appropriately match the voltage.” Reply 2. The main example Petitioner relies on describes 38 LEDs having a total voltage drop of 114 V in a circuit with a bridge rectifier having a 6 V voltage drop. Id. at 2–3 (citing Ex. 1001, 16:64–17:7). Yet the 114 V voltage drop of the LEDs alone “approximately matches” the input voltage of 120 V, without the contribution of the bridge rectifier (6 V). Id. Indeed, 114 V out of 120 V is a 95% match. Thus, this example supports Patent Owner’s view that it is the voltage drop of the LEDs themselves, not the LED circuit as a whole, that must approximately match the LED driver input. See Sur-reply 6–7.” slip op. at 16

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

      “combination. The first is that the proposed combination is not at all clear. Although Petitioner need not propose a bodily incorporation of different embodiments, Petitioner must provide a “reasoned analysis” explaining what the combination is. See DSS Tech. Mgmt., Inc. v. Apple Inc., 885 F.3d 1367, 1377 (Fed. Cir. 2018); In re Keller, 642 F.2d 413, 425 (CCPA 1981); see also Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688 F.3d 1342, 1368 (Fed. Cir. 2012) (“We must be careful not to allow hindsight reconstruction of references to reach the claimed invention without any explanation as to how or why the references would be combined to produce the claimed invention.”) (citation omitted). But the Petition never explains how or where Piepgras’s glass substrate would be combined with Piepgras’s alleged flexible substrate, the rope light of Figure 31. At most, Petitioner suggests incorporating the illumination device 500 of Figure 42 in the rope light of Figure 31. Pet. 48 (“Piepgras provides for configurations where a reflective platform (reflective substrate) mounts lighting system 500 in a manner applicable generally to the inventions of Piepgras . . ., and thus including the rope lighting application discussed above.”). As for the glass substrate, Petitioner merely states that “a POSITA would have found it predictable to configure the Shackle-Piepgras device to implement a flexible substrate mounted to the glass substrate, wherein at least one of the plurality of LED packages is mounted to the flexible substrate.” Id. (citing Ex. 1002 ¶ 150). This vague statement just parrots the claim language and does not explain anything about how the glass substrate would be included in the combination.” slip op. at 28

    Patent outcomesUS 10,750,583 not shown unpatentable
    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 10,750,583
  • Illumina, Inc. v. Ravgen, Inc.No claims unpatentable
    PTAB · Jan 25, 2023 · IPR2021-01271 · APJ David Cotta · IPR · Final written decision

    Claims 1, 3–9, 21, 22, and 24–30 were not shown unpatentable because Illumina did not prove that glucose in the cited ACD samples necessarily impeded cell lysis.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Patent Owner did not expressly contest this definition during trial, noting only that “Dr. Van Ness meets [this] definition” and “confirms [that] his opinions are the same under either party’s definition.” PO Resp. 6 (citing Ex. 2239 ¶¶ 20–25). To the extent there are minor differences in the above 14 definition and the alternative definition offered by Dr. Van Ness (Ex. 2239 ¶ 23), Dr. Van Ness’s proposal is too broad for at least the reason that it does not require the POSA have experience collecting and analyzing cell-free DNA from blood samples—subject matter relevant to the claims and applied art. Accordingly, we continue to apply Petitioner’s proposed definition here.13 In any event, the parties’ technical declarants meet or exceed either definition and there is no indication that their opinions would change depending on which definition was applied, and no argument from the parties to the contrary. Ex. 1056 ¶¶ 5–10 (overview of qualifications and experience); Ex. 2239 ¶¶ 4–7 (same).” slip op. at 14

    • Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languageDisclaimer foundTerm construed board ownDecided for patent owner

      “presents is whether a claimed agent that inhibits cell lysis may be a chelator used as an anticoagulant. The Specification and prosecution history make clear that at least one anticoagulant chelator—EDTA—is excluded from satisfying the claimed agent as recited in claim 1. As discussed above, the Specification describes an example where a sample processed in a tube with only EDTA is described as processing a sample in the “absence” of an agent that inhibits cell lysis. Ex. 1001, 89:35–57 (describing, in contrast, the EDTA + formalin sample as showing an example in the “presence of inhibitors of cell lysis”). If EDTA alone could be read as meeting the “agent” limitation, that example would make no sense. Petitioner provides no persuasive argument otherwise. The prosecution history buttresses the exclusion of the anticoagulant chelator EDTA from being the claimed “agent.” For example, during prosecution of the related ’277 patent, the Examiner at one point expressly 20 identified the EDTA in the tubes of a prior art reference as satisfying the agent term, prompting applicant’s argument that the Office was “incorrect” in doing so, and further distinguishing EDTA as merely “a well-known chelator of calcium and magnesium” that is added to blood “as an anticoagulant due to its ability to chelate calcium.” Ex. 2064, 1196 (arguing “EDTA is clearly referred to as a chelator in Applicant’s specification, not as a cell lysis inhibitor”); supra Section I(E); Ex. 1001, 32:61–64 (listing EDTA and EGTA as chelators). This, in turn, convinced the Examiner to withdraw the finding that EDTA was an “agent” as claimed and move on to art that disclosed formaldehyde as meeting that claim term. Ex. 2064, 1024 (Examiner interview summary noting that “applicant pointed out [that] EDTA could not be defined as a cell lysis inhibitor but rather was simply an anticoagulant”). This colloquy during prosecution evidences a clear and unmistakable disavowal of EDTA as being the claimed “agent.” Having determined that Patent Owner disavowed EDTA as the claimed “agent,” we next consider whether the disavowal extends more broadly to other anticoagulant chelators and, specifically, to ACD. On this record, we find that it does as explained below. In distinguishing EDTA from being the “agent,” Patent Owner relied not on properties that are unique to EDTA, but on the fact that it was a “well-known chelator” used as an anticoagulant in this technical field. Ex. 2064, 1196. Given Patent Owner’s clear intent to exclude EDTA from the scope of the claimed “agent” on the basis that it was simply an anticoagulant chelator, we find that a POSA would also have understood other anticoagulant chelators as subject to Patent Owner’s disavowal.” slip op. at 20

    • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportReference is prior artDecided for petitioner

      “20 Before institution, Patent Owner contested the sufficiency of Petitioner’s showing on whether Landes was entitled to the priority benefit of the filing date of the Landes provisional application. We disagreed that Petitioner’s showing was insufficient. Inst. Dec. 43–47. Patent Owner did not raise any issue during trial about Landes’s prior art status and, thus, has forfeited any argument that Landes is not prior art. On this record, we determine that Landes is § 102(a) prior art based on its July 31, 2003, publication date. On this record, we do not presume the claims of the ’720 patent are entitled to any earlier priority date of other applications listed in its ancestral chain. PowerOasis, Inc. v. T-Mobile USA, Inc., 522 F.3d 1299, 1305 (Fed. Cir. 2008) (explaining that “there is simply no reason to presume that claims in a [CIP] application are entitled to the effective filing date of an earlier filed application”). That is especially true with the patent’s complex priority chain, involving several CIPs leading back to a provisional application filed 26” slip op. at 26

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

      “Altogether, considering the argument and evidence of record, Petitioner has shown, at best, that it is possible for glucose to help impede cell lysis by reason of isotonicity and providing a nutrient source. But such possibilities are not enough for Petitioner to prevail on its challenge to the claims as anticipated by Landes. In re Oelrich, 666 F.2d 578, 581 (CCPA 1981) (“Inherency, however, may not be established by probabilities or 41 possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.”) (internal quotation and citation omitted); Guangdong Alison Hi-Tech, 936 F.3d at 1364 (same). Petitioner has not, on this record, met its burden to show that the glucose component of ACD in Landes’s specific method is an “agent that impedes cell lysis” in the manner claimed.” slip op. at 41

    Patent outcomesUS 7,727,720 not shown unpatentable
    Claim construction§ 102 anticipationcites KSR · Graham
    Patents in suitUS 7,727,720
  • PTAB · Dec 12, 2022 · IPR2021-01026 · APJ David Cotta · IPR · Final written decision

    Claims 1–9 and 21–30 were not shown unpatentable: Lee did not establish that ACD dextrose impeded cell lysis, and Sorenson/Rao lacked motivation to combine because formaldehyde was known to damage nucleic acids.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Dr. Van Ness’s proposed POSA level is too broad. Under that proposal, an individual with, for example, an undergraduate degree in microbiology and three years’ work experience studying the habitats of bacteria might qualify as a POSA. It is not clear that such a person would have sufficient, relevant experience in the detection of chromosomal abnormalities, especially through non-invasive methods for detecting fetal 10 genetic abnormalities in maternal samples, as described in the ’720 patent. See, e.g., Ex. 1001, 1:22–5:44 (Field of Invention and Background Art). Petitioner’s proposal of the POSA level is more precise because it requires familiarity with techniques for detecting cell-free DNA in biological samples, which is relevant to the prior art and the claimed technology. Petitioner’s proposal also appears to be more consistent with the cited prior art. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required where the prior art itself reflects an appropriate level and a need for testimony is not shown). Accordingly, we adopt Petitioner’s POSA level here, but note that our other determinations on this record would not change under Patent Owner’s POSA level.12” slip op. at 10

    • Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalTerm construed board ownDisclaimer foundDecided for patent owner

      “Owner relied not on properties unique to EDTA, but on the fact that it was a “well-known chelator” and anticoagulant: [T]he assertion by the Office that EDTA is a cell lysis inhibitor is simply incorrect. . . EDTA is not an “agent that inhibits cell lysis.” Rather, EDTA is a well-known chelator of calcium and magnesium. EDTA is routinely added to blood during the blood collection process as an anticoagulant due to its ability to chelate calcium. Ex. 2064, 1196. Given Patent Owner’s clear intent to exclude EDTA from the scope of the claimed “agent” on the basis that it was a chelator and an anticoagulant, we find that a POSA would have understood other chelators and anticoagulants to also be excluded from the scope of the claimed agent. Consistent with this understanding, during subsequent prosecution of the application that issued as the ’720 patent, Patent Owner argued that the Holodniy reference, which disclosed a method of detecting free nucleic acid in which blood was collected in tubes containing ACD, “fail[ed] to teach or suggest a method for detecting free nucleic acid comprising, inter alia, isolating free nucleic acid from a non-cellular fraction of a sample, wherein an agent that impedes cell lysis has been added.” Ex. 1003, 1428 (emphasis added). On the salient point here, the Examiner agreed, concluding that “Holodniy et al. teach a method of detecting free nucleic acid which comprises all of the limitations of Claim 1, except these authors do not teach that their samples comprise an agent that impedes cell lysis.” Id. at 1344 (emphasis added); see also id. at 1156 (finding that Adams et al., a reference that also collects blood in tubes containing ACD, taught “all of the limitations recited in Claim 1 except these authors do not teach adding an agent that impedes cell lysis to the sample.”). And Patent Owner argues 15 persuasively, without dispute from Petitioner, that ACD is the “only” addition to the collection tubes besides the blood sample itself. Sur-reply 4 (citing Ex. 1016, 2; Ex. 2023, 20:52–54). This supports that neither the Examiner nor the Patent Owner considered ACD as an anticoagulant chelator to be an “agent,” as that term is used in claim 1. Accordingly, we construe the phrase “agent that impedes cell lysis” to” slip op. at 15

    • Strike new argumentNew argument consideredDecided for petitioner

      “function to prevent cell lysis, “by: (1) interacting with and stabilizing the cell membrane; (2) maintaining osmolarity so that the cells do not rupture; and (3) providing a nutrient source.” Reply 3 (citing Ex. 1002 ¶¶ 22–23; 2001 ¶ 169; Ex. 1059 ¶ 5; Ex. 1054, 125:3–127:12; 1057, 3–4, and Ex. 1056, 7– 13, 15–19, 24). Patent Owner argues that the evidence as to how dextrose functions to prevent cell lysis should have been presented in the Petition. Sur-reply 16. On this record, we do not agree. While this evidence could have been included in the Petition, it is responsive to arguments raised in Patent Owner’s response. See PO Resp. 18–22. In any event, consideration of this evidence simply explains how and why dextrose has the capacity to impede cell lysis, and we have already found that the ’720 patent provides 25 evidence that dextrose has this capacity. Under the circumstances, it was therefore reasonable for Petitioner, in the Petition, to rely on such disclosures of the patent itself. Further, consideration of how and why dextrose impedes cell lysis largely benefits Patent Owner, by providing reasons why dextrose might not inhibit cell lysis under the specific circumstance present in Lee.” slip op. at 25

    • Expert testimonyPetitioner expert discountedPatent owner expert creditedMixed

      “interact with and stabilize the cell membrane. Reply 3 (citing Ex. 1002 ¶¶ 22–23). In the cited testimony, Dr. Edwards states, “it was known that carbohydrates have a role in membrane stabilization” and that dextrose “is a membrane stabilizer.” Ex. 1002 ¶¶ 22–23. This is consistent with the teaching in the ’720 patent that glucose is “[a]n agent that stabilizes cell membranes.” See e.g., Ex. 1001, 6:49–56. The evidence thus supports that dextrose can help to stabilize cell membranes. However, this evidence is tempered by evidence supporting that the “impact of carbohydrates on biological membranes is extremely complex” and that it is “extremely difficult to predict how solutes such as carbohydrates will affect biological membranes.” Ex. 2231, 60:18–61:2, 83:14–18 (Dr. Edwards testimony). This is because “there’s a finite but long – long list of variables that will impact the – the mechanism by which carbohydrate interacts with the cell membrane.” Id. at 66:20–67:7; see also id. at 66:1–15 (identifying temperature, concentration and pressure as variables that play a role in how carbohydrates interact with biological membranes); id. at 68:1–17 (identifying prior and simultaneous exposure to other substances as variables that play a role in how carbohydrates interact with biological membranes). 26 Petitioner also provides evidence that dextrose helps prevent cell lysis by “maintaining osmolarity so that cells do not rupture.” Reply 3 (citing Ex. 2001 ¶ 169; Ex. 1056, 7–13, 24; Ex. 1059 ¶ 5). We agree that the cited evidence supports that dextrose has the ability to prevent cell rupture by maintaining isotonicity. In particular, Rapoport found that erythrocytes in an acid-citrate glucose solution underwent osmotic hemolysis at a slower rate than erythrocytes in a simple citrate solution. Ex. 1056, 613. However, Patent Owner introduces evidence, which we credit, that the failure to maintain isotonicity does not necessarily cause cell lysis. Ex. 2299, 237:4– 16 (Dr. Edward’s testimony). For example, cells placed in a hypertonic solution may “shrink or kind of shrivel” rather than burst, and cells placed in a hypotonic solution may swell, but will not necessarily lyse. Id. at 245:3– 16, 246:17–247:8.” slip op. at 26

    Patent outcomesUS 7,727,720 not shown unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 7,727,720
  • PTAB · Dec 12, 2022 · IPR2021-00862 · APJ Sheridan K Snedden · IPR · Final written decision

    Claims 1–24 were not shown unpatentable because Petitioner failed to establish the proposed prior-art combinations and the required motivation to combine with a reasonable expectation of success.

    RulingsFinal written decision
    • Skill levelSkill level board ownDecided for patent owner

      “The parties present compelling argument and evidence that one of ordinary skill in the art would include those with experience in ophthalmology, as well as in the research, manufacture, and design of medical optics or medical lasers. Pet. 25; PO Resp. 9–10. The evidence of record also demonstrates that few individuals actually had such comprehensive experience. Rather, teams of individuals with different expertise and various academic degrees (Ph.D.s, B.S.s, and M.D.s) would work together to design laser surgery systems intended to make incisions in the lens of the eye. See, e.g., Ex. 1041 (several authors are M.D.s); Ex. 1042 (the authors’ degrees include Ph.D.s, an M.D., and a B.S.); see also Ex. 1053; Ex. 1054; Ex. 1055; Ex. 2010; Ex. 2019. Thus, we find that the person of ordinary skill in the art would have been either an ophthalmic surgeon or someone with a Ph.D., M.S., or B.S. degree in physics, biomedical engineering, or a related science such as nuclear engineering, having experience in researching, manufacturing, or designing medical optics or medical lasers (e.g., five years of experience for a Ph.D. or more to compensate for lesser degrees), and that such persons would have worked in collaboration with one another to fill any necessary gaps in knowledge (e.g., the engineer would consult the medical doctor on clinical issues or physiology and the medical doctor would consult the engineer on technical issues). This definition marries the two proposed by the parties.” slip op. at 11

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

      “Petitioner does not assert that any claim term requires express construction. See Pet. 6 (stating that it “reserves the right to respond to any constructions that [Patent Owner] submits”). Patent Owner does not present any remarks regarding claim construction. See generally PO Resp. On this record, we determine that no claim terms require express construction because it is not essential to our conclusions on patentability. See Nidec Motor., 868 F.3d at 1017 (quoting Vivid Techs., 200 F.3d at 803 (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”)). 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.” slip op. at 13

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

      “summarized above, we find that the evidence of record does not support a conclusion that it would have been simple, straightforward, or otherwise routine to convert Swinger’s manual HeNe aiming system and Swinger’s surgeon-identification-of-target-tissue step to a computer-controlled, OCT-guided laser system. Even assuming that a person of ordinary skill in the art would have combined the teachings of Swinger and Baikoff to achieve a laser surgical system incorporating an OCT imaging system, that combination still would not have achieved the required “computer system” of the claims and all of its programmed surgical functionality, particularly, using a computer system to construct an anterior capsulotomy cutting region based on the image data. Petitioner relies on the ability of a person of ordinary skill in the art to configure Swinger’s computer control unit with the missing functionality, thus necessitating an electronic conversion of the steps performed using Swinger’s direct visualization method using a HeNe aiming beam to manually identify a surgical treatment region for laser surgery. Ex. 1039, 34:52–57; Ex. 2088 ¶¶ 55–59, 66. That conversion, however, involves the incorporation of OCT imaging technology as the basis for a computer-controlled system to plan and then implement the planned cataract surgery, two technological leaps that the record fails to show were known or suggested. In particular, the evidence of record does not support a conclusion that OCT was a well-known system used routinely, if at all, in the identification of treatment regions in the lens or lens capsule for cataract surgery, and further does not support a conclusion that a computer-controlled system to plan and to implement a planned cataract surgery in the lens was commonplace or even considered before the invention.” slip op. at 25

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

      “The evidence of record demonstrates, however, that modifying an existing corneal surgery system to image and perform surgery on the lens was not the simple task asserted by Petitioner. For example, in a patent application filed in November 2009, Petitioner asserted that due to the different depth ranges for the laser’s focus, “laser systems designed for corneal procedures do not offer solution[s] for the considerable challenges of performing surgery on the lens of the eye.” Ex. 2007, 4:65–67, 5:30–36, code (22). Similarly, in a different patent filed in December 2008, Petitioner outlined the various challenges in developing laser surgery systems for creating incisions in the lens, including the difficulty in focusing a laser beam that propagates through regions of the eye with different optical properties and different curvatures. Ex. 2014, 15:51–16:18, code (22). This patent then states: Because of all the described hard challenges, corneal surgical laser systems are qualitatively simpler than lens surgical lasers. This is well supported by the fact that even though corneal surgical systems were suggested about 40 years ago, none have been adapted successfully for lens surgery to date. Id. at 16:13–18. During prosecution of another patent filed in 2008, and in responses to office actions filed in 2012 and 2013, Petitioner argued that a corneal OCT system “simply will not work” on the lens and that it would not have been obvious to modify such an OCT system to image the lens. Ex. 2015, 898, 1591, 1788. This was because OCT systems designed to image the lens would be required to deliver and scan an imaging beam “to a depth ten times bigger and a depth range ten times bigger” than an OCT system designed to image the cornea. Id. at 1591. According to Petitioner, “it is not obvious” to modify an OCT imaging system to achieve a depth and scanning range that is ten times larger than that disclosed in the art. Id. at 898 (“Increasing a system’s performance by an order of magnitude cannot be regarded as obvious.”), 1590–1591. Petitioner’s arguments presented in its own patents and during their” slip op. at 39

    Patent outcomesUS 8,709,001 not shown unpatentable
    Claim construction§ 103 obviousness
    Patents in suitUS 8,709,001
  • PTAB · Dec 12, 2022 · IPR2021-00858 · APJ Sheridan K Snedden · IPR · Final written decision

    Claims 1–19 were not shown unpatentable because Petitioner failed to establish that the asserted prior-art combinations would have been made with a reasonable expectation of success.

    RulingsFinal written decision
    • Skill levelSkill level board ownOther

      “The parties present compelling argument and evidence that one of ordinary skill in the art would include those with experience in ophthalmology, as well as in the research, manufacture, and design of medical optics or medical lasers. Pet. 26; PO Resp. 8–9. The evidence of record also demonstrates that few individuals actually had such comprehensive experience. Rather, teams of individuals with different expertise and various academic degrees (Ph.D.s, B.S.s, and M.D.s) would work together to design laser surgery systems intended to make incisions in the lens of the eye. See, e.g., Ex. 1041 (several authors are M.D.s); Ex. 1042 (the authors’ degrees include Ph.D.s, an M.D., and a B.S.); see also Ex. 1053; Ex. 1054; Ex. 1055; Ex. 2010; Ex. 2019. Thus, we find that the person of ordinary skill in the art would have been either an ophthalmic surgeon or someone with a Ph.D., M.S., or B.S. degree in physics, biomedical engineering, or a related science such as nuclear engineering, having experience in researching, manufacturing, or designing medical optics or medical lasers (e.g., five years of experience for a Ph.D. or more to compensate for lesser degrees), and that such persons would have worked in collaboration with one another to fill any necessary gaps in knowledge (e.g., the engineer would consult the medical doctor on clinical issues or physiology and the medical doctor would consult the engineer on technical issues). This definition marries the two proposed by the parties.” slip op. at 11

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

      “Petitioner does not assert that any claim term requires express construction. See Pet. 7 (stating that it “reserves the right to respond to any constructions that [Patent Owner] submits”). Patent Owner does not present any remarks regarding claim construction. See generally PO Resp. On this record, we determine that no claim terms require express construction because it is not essential to our conclusions on patentability. See Nidec Motor., 868 F.3d at 1017 (quoting Vivid Techs., 200 F.3d at 803 (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”)). 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.” slip op. at 13

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

      “Having considered the parties’ positions and evidence of record, summarized above, we find that the evidence of record does not support a conclusion that it would have been simple, straightforward, or otherwise routine to convert Swinger’s manual HeNe aiming system and Swinger’s surgeon-identification-of-target-tissue step to a computer-controlled, OCTguided laser system. Even assuming that a person of ordinary skill in the art would have combined the teachings of Swinger and Baikoff to achieve a laser surgical system incorporating an OCT imaging system, that combination still would not have achieved the required “control system” of the claims and all of its programmed surgical functionality. Petitioner relies on the ability of a person of ordinary skill in the art to configure Swinger’s computer control unit with the missing functionality, thus necessitating an electronic conversion of the steps performed by a surgeon using Swinger’s direct visualization method using a HeNe aiming beam to manually identify a surgical treatment region for laser surgery. Ex. 1039, 34:52–57; Ex. 2088 ¶¶ 55–59, 66. That conversion, however, involves the incorporation of OCT imaging technology as the basis for a computer-controlled system to plan and then implement the planned cataract surgery, two technological leaps that the record fails to show were known or suggested. In particular, the evidence of record does not support a conclusion that OCT was a well-known system used routinely, if at all, in the identification of treatment regions in the lens or lens capsule for cataract surgery, and further does not support a conclusion that a computer-controlled system to plan and to implement a planned cataract surgery in the lens was commonplace or even considered before the invention. We recognize that Petitioner directs us to the testimony of Dr. Izatt who opines that a person of ordinary skill in the art would have found it obvious to, for example, use a controller to determine the claimed scanning pattern. Ex. 1001 ¶ 159; Pet. 32–33; Reply 3–5; see also Ex. 1123 ¶ 31 (“Once the anterior capsule is identified, it is a relatively simple process to determine the location to place the capsulotomy.”). Here, however, we agree with Patent Owner that the Petition and supporting testimony fails to provide the requisite reasoned analysis with sufficient evidence to support Petitioner’s position on obviousness. In particular, absent some evidentiary support beyond Dr. Izatt’s and Dr. Tipperman’s bare opinions that it would have been obvious to program a controller to bridge the gap between the functionality disclosed in Swinger and the required functionality of the challenged claims, we are unwilling to accept this line of reasoning. PO Resp. 27; Sur-Reply 4–7; Ex. 1001 ¶ 159; see also DSS, 885 F.3d at 1374 (Fed. Cir. 2018) (A skilled artisan’s “common sense” or “common knowledge” can potentially “fill in a missing limitation only when ‘the limitation in question was unusually simple and the technology particularly straightforward.’” (emphasis omitted)).” slip op. at 25

    • Strike new argumentNew argument disregardedDecided for patent owner

      “Inter partes review must proceed in accordance with the Petition and the arguments set forth therein. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1356 (2018). “It is of the utmost importance that petitioners in the IPR proceedings adhere to the requirement that the initial petition identify ‘with particularity’ the ‘evidence that supports the ground for the challenge to each claim.’” Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369 (Fed. Cir. 2016). Arguments made in a different document, such as an expert’s declaration, may not be incorporated-by-reference in the Petition. 37 C.F.R. § 42.6(a)(3); see also General Access Solutions, Ltd. v. Sprint Spectrum L.P., 811 F. App’x 654, 658 (Fed. Cir. 2020) (noting that the Board did not abuse its discretion in enforcing its rules under 37 C.F.R. § 42.6(a)(3)) (non-precedential)).” slip op. at 35

    Patent outcomesUS 8,425,497 not shown unpatentable
    Claim construction§ 103 obviousness
    Patents in suitUS 8,425,497
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