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  • Apple Inc. v. Masimo CorporationSome claims unpatentable
    PTAB · Jul 3, 2025 · IPR2024-00290 · APJ Richard H Marschall · IPR · Final written decision

    Claims 1–3, 6, 11–17, 21, 22, 27, 28, 32, 34, 36, 37, and 42–44 are unpatentable as obvious; claims 4 and 18–20 were not shown unpatentable.

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

      “In our Institution Decision, we deemed the differences in the parties’ proposals not material due to their substantial overlap, adopted Patent Owner’s proposal for purposes of that Decision, noted that the outcome of the Decision would not change if we adopted Petitioner’s proposal, and instructed the parties to “explain the differences and their relevance to the patentability issues in this case, and state whether any issue in the case turns on those differences” if either party continued to propose differing proposals during trial. Inst. Dec. 10–11. After institution, neither party has explained the materiality of the differences in their proposals or argued that any issues in this case turn on those differences. Based on our review of the parties’ proposals, we find Patent Owner’s proposal consistent with the level of skill exemplified by the prior art of record and the disclosure of the ’223 patent. Accordingly, we apply Patent Owner’s proposal in our analysis in this Decision. See Okajima, 261 F.3d at 1355 (“[T]he prior art itself” may reflect an appropriate level of the ordinary level of skill in the art. (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). The outcome of this Decision would not change if we applied Petitioner’s proposed definition.” slip op. at 9

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

      “persuasive and reject Patent Owner’s argument that we should construe the limitation as requiring the absence of one parameter from the display prior to the replacement and the absence of the other parameter after the replacement. We do not view either requirement proposed by Patent Owner as justified based on our review of the claims, specification, and prosecution history.” slip op. at 16

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

      “preponderance of the evidence that the combination of Naghavi, Hochstedler, and Burnes discloses all of the limitations of claim 1 and that a POSITA would have been motivated to combine the references in the manner Petitioner proposes with a reasonable expectation of success. See Pet. 9–30. Accordingly, we determine that Petitioner proves by a preponderance of the evidence that claim 1 would have been obvious based on Naghavi, Hochstedler, and Burnes.” slip op. at 58

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

      “proposed combination based on the argument that a POSITA would have been motivated to switch the layout responsive to a parameter value changing. Pet. 11–15 (citing Ex. 1003 ¶¶ 35–40, 47–52). For example, we agree with Petitioner that a motivation exists to change the layouts to “best suit the condition of [the] patient” because Naghavi expressly describes an “interactive and dynamic” GUI that “may automatically detect changes in health status . . . and automatically react and rearrange the available options to best suit the condition” of the patient. Ex. 1005 ¶ 63. The supporting expert testimony persuasively relies on this aspect of Naghavi when concluding that “such a change in the severity of a parameter can indicate a change in the patient’s health that may require close monitoring” and a POSITA “would have been motivated to implement this approach of the combination in order to achieve” Naghavi’s objectives. Ex. 1003 ¶ 48 (citing Ex. 1005 ¶ 63); see also Pet. Reply 23 (“[T]he rearrangement of parameters, as already suggested by Naghavi and implemented according to Hochstedler, advantageously ensures an easy-to-use user interface, e.g., by highlighting information that has changed to warrant user attention.” (citing Pet. 13–14; Ex. 1003 ¶¶ 42–43)); Ex. 1003 ¶¶ 42–43.” slip op. at 51

    Patent outcomesUS 8,190,223 mixed
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 8,190,223
  • 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 · Aug 27, 2024 · IPR2023-00521 · APJ Jon B Tornquist · IPR · Final written decision

    Claims 19–61, 63–77, and 79 are unpatentable as anticipated by Doud; claims 78, 80, and 81 are not shown unpatentable. The contingent motion to amend is granted in part and denied in part.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner contends that a person of ordinary skill in the art “would have at least a Ph.D. in chemistry, metallurgy, or material science or material engineering” or, in the alternative, “would have a Bachelor of Science or Master of Science degree in one of these disciplines plus experience involving the use and design of dissolvable metal alloys for use in creating tools and other downhole parts for well drilling or completion activities.” Pet. 13–14. Patent Owner does not oppose Petitioner’s contentions regarding the level of ordinary skill in the art. PO Resp. 12 n.4. Upon review of the prior art of record and the parties’ arguments, we adopt Petitioner’s unopposed definition of the ordinarily skilled artisan as it is consistent with the prior art of record.” slip op. at 7

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

      “With respect to claim 19, Petitioner proposes constructions for the terms “in situ precipitate” and “a plurality of particles of said in situ precipitate having a size of no more than 50 µm.” Pet. 11–12. With respect to claims 76–81, Petitioner proposes a construction for the term “wherein said additive material includes one or more metal materials selected from the group consisting of 0.1–35 wt. % copper, 0.1–24.5 wt. % nickel and 0.1–20 wt. % cobalt.” Id. at 13. Patent Owner contends no claims require construction for purposes of this Decision. PO Resp. 12 n.4, 17–18; Mot. 16–17. Upon review of the prior art of record, we determine that no claim terms require express construction for purposes of this Final Written Decision. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those 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 8

    • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateWritten description adequateMixed

      “Ex. 2027, 20:25–21:5 (emphasis added). The disclosure that the “magnesium composite” of “[t]he present invention” “includes at least 50 wt% magnesium” is unambiguous and constitutes strong evidence that the inventors were not in possession of a magnesium composite with less than 50 wt. % magnesium, or additive concentrations above 50 wt. %. See SciMed Life Systems, Inc. v. Advanced Cardiovasular Systems, Inc., 242 F.3d 1337, 1343 (Fed. Cir. 2001) (noting that a description of the “present invention” as having a particular structure “is strong evidence that the claims should not be read to encompass the opposite structure”). Consistent with this conclusion, the original claims of the ’295 application all limited the additive material in the composite to 0.05 wt %–45 wt %. Ex. 2027, 26:1– 13, 29:9–15. Likewise, in each example where copper, nickel, or cobalt additives are used in the range recited in the proposed substitute claims, the magnesium composite is “over 50 wt% magnesium,” and any claims that do not require this range of magnesium are limited to an additive range of “about 0.05 wt%–45 wt% of said mixture.”8 Ex. 2027, 6:13–7:4, 7:16–19, 8 Written description support is considered from the view point of the ordinarily skilled artisan. Ariad Pharms., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). Patent Owner, bearing the burden to show written description support in any priority application for which it seeks the benefit of its filing date, provides no testimony from an ordinarily skilled artisan regarding written description support in the ’295 application, or any evidence to show what such an artisan would conclude from the express disclosures of the ’295 application. Lectrosonics, Paper 15 at 7; In re NTP, 654 F.3d 1268, 1276 (Fed. Cir. 2011) (noting that “a patent’s claims are not entitled to an earlier priority date merely because the patentee claims priority . . . Rather, for a patent’s claims to be entitled to an earlier priority date, the patentee must demonstrate that the claims meet the requirements of 35 U.S.C. § 120”). Where there is any ambiguity in the disclosures of the ’295 application, the absence of supporting testimony tends to cut against 26:2–31:2; see Ex. 1005 ¶¶ 12, 13, 18, 19, 16–21, 26, 28, claims 16–21, 26– 28. In view of the foregoing, we are not persuaded that Patent Owner has demonstrated that the inventors of the priority applications were in possession of a magnesium cast composite that included less than 50 wt. % magnesium, or greater than 50 wt. % additives. As proposed substitute claim 104 encompasses a magnesium cast composite with up to 90 wt. % additives, and therefore as little as 10 wt. % magnesium, Patent Owner has not demonstrated that the full scope of this claim finds written description support in any application prior to the ’915 application, filed on October 12, 2018.” slip op. at 17

    • Disclosure Requirements (§112) › Definiteness (Nautilus)DefiniteIndefiniteMixed

      “The definiteness requirement of § 112(a) is satisfied when “a patent’s claims, viewed in light of the specification and prosecution history, inform those skilled in the art about the scope of the invention with reasonable clarity.” Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 910 (2014); see 37 C.F.R. § 42.100(b) (changing the claim construction standard used to review a claim proposed in a motion to amend from the broadest reasonable construction to the “same construction standard that would be used to construe the claim in a civil action under 35 U.S.C. [§] 282(b)”). Proposed substitute claim 104 generically requires “in situ precipitate” and also a specific type of in situ precipitate: “in situ galvanically-active intermetallic precipitate.” Mot. Appendix A. Although this claim would have best been clarified by Patent Owner after seeking preliminary guidance on its Motion to Amend, upon review of the written description, claims, and figures of the ’740 patent, as well as Patent Owner’s clarification in its Reply to the Opposition, we agree with Patent Owner that one of ordinary skill in the art would have understood that the “in situ galvanically-active intermetallic precipitate” is merely a more complete description of the “in situ precipitate” mentioned earlier in the sentence. Mot. Reply 4. As such, we do not find that this part of proposed substitute claim renders claim 104 indefinite.” slip op. at 22

    Patent outcomesUS 10,689,740 mixed
    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Graham · Nautilus
    Patents in suitUS 10,689,740
  • Apple Inc. v. Alivecor, Inc.Some claims unpatentable
    PTAB · Oct 26, 2023 · IPR2022-00872 · APJ Jeffrey N Fredman · IPR · Final written decision

    Claims 1, 2, 4–8, 10, 12, and 13 are unpatentable as obvious; claims 3, 9, and 11 were not shown unpatentable because the combinations lacked a persuasive reason to record spoken messages simultaneously with ECG …

    RulingsFinal written decision
    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningDecided for patent owner

      “PO Resp. 9. Patent Owner asserts “a POSA would have understood the plain and ordinary meaning of the term ‘acoustic signal’ [is] a signal that is transmitted as a sound wave through the ambient environment.” Id.; Ex. 2003 ¶ 25. Patent Owner therefore asserts a POSA would have understood the claimed “frequency modulated ECG acoustic signal” is a signal that is transmitted as a sound wave through the ambient environment, [and excludes] signals transmitted by electronic or wireless radio means, because claim 1 requires the acoustic signal to be “received from a built-in microphone of the smartphone.” PO Resp. 9; Ex. 2003 ¶ 26. Petitioner responds by asserting that “a POSITA would have understood that acoustic transmission is a form of wireless transmission.” Pet. Reply 24; Ex. 1021, 46:7–47:5 (citing the Jafari Deposition where Dr. Jafari stated “in the event of an acoustic signal, there is no need to connect a wire”) Having considered the entire record, we do not find there is a substantive dispute over the term “acoustic signal” as both Patent Owner and Petitioner agree that acoustic signals include wireless signals transmitted as a sound wave through the environment. We will apply this understanding in our further analysis.” slip op. at 7

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “A person of ordinary skill in the art (“POSITA”) would have had either (1) at least a bachelor of science in electrical engineering, mechanical engineering, or biomedical engineering, or a related discipline, with at least two years of relevant multidisciplinary work experience designing wearable devices and/or sensors for measuring physiological signals or parameters of mammals, or (2) a medical degree and at least five years of relevant work experience designing wearable devices and/or sensors for measuring physiological signals or parameters of mammals.” slip op. at 5

    • Expert testimonyPetitioner expert creditedPatent owner expert creditedDecided for petitioner

      “interference of sound waves was a known phenomenon at the time of the invention does not demonstrate that the ordinary artisan would have had reason to select particular carrier frequencies for the ECG acoustic signals that avoided human voice frequencies in the absence of any disclosure that such frequencies were known to interfere. Rather, we agree with Patent Owner that this is hindsight reasoning because until the ’882 patent pointed out this concern in the context of claim 1, there is no indication the prior art recognized that human voice interference was an issue.” slip op. at 26

    • Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightMixed

      “that Vyshedskiy’s disclosure of a list of preferred carrier frequencies represents a permissible “obvious to try” situation. In KSR, the Supreme Court stated that a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103. KSR, 550 U.S. at 421. And simply because the prior art “discloses a multitude of effective combinations does not render any particular formulation less obvious.” Merck & Co. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989). The instant facts represent a situation where, at the time of invention in 2010, it would have been obvious to try the known carrier frequencies of Vyshedskiy for modulation of the acoustic ECG signal of Albert in the claimed frequency range of 6 kHz to 20 kHz because these carrier frequencies would have been obvious alternatives to try to address Vyshedskiy’s disclosed design need for simultaneous measurement of heart sound auscultation and ECG heart cycle. See Pet. 17 (citing Ex. 1005 ¶¶ 13– 15).” slip op. at 27

    Patent outcomesUS 8,509,882 mixed
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 8,509,882
  • PTAB · Oct 11, 2023 · IPR2022-00796 · APJ David Cotta · IPR · Final written decision

    Claims 1–13 are unpatentable as obvious over Sun and the Teva Press Release; the Board did not reach the Bigal ground.

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

      “POSA helpful. Moreover, Patent Owner’s definition appears to be consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’434 patent. We do not see a need to specify that the POSA would have experience studying the role of CGRP in migraine. Accordingly, for purposes of this Decision, we accept Patent Owner’s proposed definition of the person of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). The differences between Petitioner’s and Patent Owner’s identification of the POSA do not materially affect our decision. Put another way, we would reach the same decision under either definition.” slip op. at 8

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

      “adverse event” beyond the portion of the Specification defining “inadequate response” to include when “treatment has to be interrupted because of adverse events that made it intolerable.” Ex. 1045, 6:45–52; PO Resp. 13– 14 (acknowledging that “[t]he ’434 patent does not provide an express definition of an ‘adverse event’” and citing only extrinsic evidence); Pet. Reply 22–25 (citing only extrinsic evidence); PO Sur-Reply 18–19 (citing only extrinsic evidence). Like the parties, we do not find any other intrinsic evidence bearing on the construction of “adverse event.” Accordingly, we turn to the extrinsic evidence provided by the parties. slip op. at 11

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

      “d) Conclusion regarding motivation to combine We find that Petitioner has established, by a preponderance of the” slip op. at 64

    • ExcludeMotion to exclude, deniedMixed

      “A. Exhibits 1065, 1073, 1088, 1089, 1220, and 1221 We do not rely on Exhibits 1065, 1073, 1088, 1089, 1220, and 1221 in our Final Written Decision. Accordingly, we dismiss Patent Owner’s Motion as it relates to these exhibits.” slip op. at 102

    Patent outcomesUS 10,392,434 unpatentable
    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 10,392,434
  • PTAB · Sep 25, 2023 · IPR2022-00739 · APJ David Cotta · IPR · Final written decision

    Claims 1–30 are unpatentable as obvious over Sun, Dodick, and Sharma; the Board did not reach the separate Dodick and Sharma ground.

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

      “(iii) Conclusion with respect to Group I patients In sum, we find that the only difference between Sun’s patients who” slip op. at 33

    • Expert testimonyPetitioner expert creditedOther

      “be advantageous as compared to galcanezumab on the basis that galcanezumab is a “less selective agent” than erenumab. Patent Owner and Dr. Grosberg cite Shi 2016 (Ex. 2049) as teaching the “high selectivity” of erenumab for blocking the CGRP complex as compared to “less selective agents,” and use this teaching to imply that galcanezumab is less selective than erenumab. PO Resp. 22; Ex. 2037 ¶ 218. But, as Dr. Hay explains, “[t]he ‘less selective agents’ that Shi 2016 refers to are the small-molecule CGRP receptor antagonists, Gepants, not galcanezumab.” Ex. 1239 ¶ 29. We find Dr. Hay’s testimony on this point persuasive, as it is consistent with Shi 2016. See Ex. 2049, 2 (discussing concerns regarding small molecule CGRP antagonists that have prevented their approval and opining that “[a] monoclonal antibody may be a preferred modality to target the CGRP receptor”). Moreover, Shi 2016 concludes with a discussion of the advantages of the superior selectivity of mAbs as a class. Id. at 8 (discussing advantages of mAbs over small molecule CGRP-receptor antagonists, noting “[i]n addition to high potency and superior selectivity, which may provide the benefit of fewer off-target side effects, monoclonal antibodies provide advantages that make them better suited for preventive treatment compared with small molecules”); Ex. 1239 ¶ 32 (interpreting Shi as teaching that “antibodies as a class have limited off-target effects as compared to small molecules because they bind to fewer biological targets and are therefore considered more specific.”). Accordingly, the evidence of” slip op. at 50

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner

      “1. “A subject having refractory migraine” The phrase “a subject having refractory migraine” appears in the preamble to claim 1. Ex. 1002, 173:2–3. The parties agree that the preamble is limiting because it provides context and antecedent basis for terms in the body of the claim. Pet. 12 (“Claim 1’s preamble . . . should be construed as limiting at least because it provides context and antecedent [basis] for the claimed ‘therapeutically effective amount.’”); PO Resp. 9 (“There is no dispute that the preamble ‘[a] method of treating or preventing migraine in a subject having refractory migraine, the method comprising’ is reasons expressed by the parties. Rapoport v. Dement, 254 F.3d 1053, 1059 (Fed. Cir. 2001) (finding that the phrase “treatment of sleep apneas” in the preamble of an interference count was limiting because it provided antecedent basis for the phrase “to a patient in need of such treatment” in the body of the interference count); see also Eli Lilly Co. v. Teva Pharmas Int’l GmbH, 8 F.4th 1331, 1340–41 (Fed. Cir. 2021) (discussing construction of claims directed to “methods of using a composition for a specific purpose,” explaining, “while there is no bright-line rule for determining whether a preamble is limiting, we have generally construed statements of intended purpose in such method claims as limiting”). We turn now to the meaning of the phrase “a subject having refractory migraine.” The parties agree that the ’161 patent expressly defines the phrase “a subject having refractory migraine.” Pet. 13; PO Resp. 9. In this regard, the ’161 patent states: As used herein, refractory migraine patients (or “subject having refractory migraine”) are considered refractory if they have a documented inadequate response (in a medical chart or by treating physician’s confirmation) to at least two preventive medications (from a different cluster, defined below). Refractory migraine patients can also be considered refractory if they have a documented inadequate response (in a medical chart or by treating physician’s confirmation) to two to four classes of prior preventive medications (from different cluster[s], as defined below), e.g., inadequate response to two classes of prior preventive medications, inadequate response to three classes of prior preventative medications, or an inadequate response to four classes of prior preventative medications. Ex. 1002, 18:61–19:7. Thus, a “subject having refractory migraine” should be construed as: a migraine patient having a documented inadequate least two preventive medications from a different cluster. Id.” slip op. at 8

    • ExcludeMotion to exclude, deniedMixed

      “A. Exhibits 1065, 1073, 1088, 1089, 1220, and 1221 We do not rely on Exhibits 1065, 1073, 1088, 1089, 1220, and 1221 in our Final Written Decision. Accordingly, we dismiss Patent Owner’s Motion as it relates to these exhibits.” slip op. at 107

    Patent outcomesUS 11,028,161 unpatentable
    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,028,161
  • PTAB · Sep 25, 2023 · IPR2022-00738 · APJ David Cotta · IPR · Final written decision

    Claims 1–30 are unpatentable as obvious over Sun, Dodick, and Sharma; the Board did not reach the alternative ground.

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

      “B. Level of Ordinary Skill in the Art In determining the level of skill in the art, we consider the problems” slip op. at 6

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

      “1. “A subject having refractory migraine” The phrase “a subject having refractory migraine” appears in the preamble to claim 1. Ex. 1001, 173:2–3. The parties agree that the preamble is limiting because it provides context and antecedent basis for terms in the body of the claim. Pet. 12 (“Claim 1’s preamble . . . should be construed as limiting at least because it provides context and antecedent [basis] for the claimed ‘therapeutically effective amount.’”); PO Resp. 9 (“There is no dispute that the preamble ‘[a] method of treating or preventing migraine in a subject having refractory migraine, the method comprising’ is limits the claim for the reasons expressed by the parties. Rapoport v. Dement, 254 F.3d 1053, 1059 (Fed. Cir. 2001) (finding that the phrase “treatment of sleep apneas” in the preamble of an interference count was limiting because it provided antecedent basis for the phrase “to a patient in need of such treatment” in the body of the interference count); see also Eli Lilly Co. v. Teva Pharmas Int’l GmbH, 8 F.4th 1331, 1340–41 (Fed. Cir. 2021) (discussing construction of claims directed to “methods of using a composition for a specific purpose,” explaining, “while there is no bright-line rule for determining whether a preamble is limiting, we have generally construed statements of intended purpose in such method claims as limiting”). We turn now to the meaning of the phrase “a subject having refractory migraine.” The parties agree that the ’160 patent expressly defines the phrase “a subject having refractory migraine.” Pet. 13; PO Resp. 9. In this regard, the ’160 patent states: As used herein, refractory migraine patients (or “subject having refractory migraine”) are considered refractory if they have a documented inadequate response (in a medical chart or by treating physician’s confirmation) to at least two preventive medications (from a different cluster, defined below). Refractory migraine patients can also be considered refractory if they have a documented inadequate response (in a medical chart or by treating physician’s confirmation) to two to four classes of prior preventive medications (from different cluster[s], as defined below), e.g., inadequate response to two classes of prior preventive medications, inadequate response to three classes of prior preventative medications, or an inadequate response to four classes of prior preventative medications. Ex. 1001, 18:59–19:5. Thus, a “subject having refractory migraine” should be construed as: a migraine patient having a documented inadequate least two preventive medications from a different cluster. Id.” slip op. at 8

    • Expert testimonyPatent owner expert discountedDecided for petitioner

      “understand the term “adverse event” to be limited to “serious” events. Ex. 2004, 1; Ex. 1208, 1; Ex. 1209, 6; Ex. 1210, 8. The only evidence to the contrary is the testimony of Dr. Grosberg. Ex. 2037 ¶ 45. Because Dr. Grosberg’s testimony is inconsistent with the evidence he relies upon, we decline to give it substantial weight. We recognize that the Specification of the ’160 patent includes language imposing some degree of severity on the “adverse event.” Specifically, the adverse event must be significant enough to cause treatment to be “interrupted” because the event made the treatment become “intolerable by the patient.” But, we find no support in the record for imposing an additional severity requirement by effectively limiting the term “adverse event” to “serious adverse events.” Accordingly, we decline to construe the term “adverse event” to mean “a serious undesirable experience associated with the use of a treatment” as proposed by Patent Owner. PO Resp. 12. We do not find it necessary to further construe the term “adverse event” to resolve this dispute.” slip op. at 14

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

      “d) Conclusion regarding Sun’s disclosure of the claimed patients For the reasons discussed supra §§ II.F.1.a–c, we find that Petitioner” slip op. at 40

    Patent outcomesUS 11,028,160 unpatentable
    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,028,160
  • PTAB · May 22, 2023 · PGR2022-00009 · APJ Monica S Ullagaddi · PGR · Final written decision

    Claims 1–5, 7–12, and 14–19 are unpatentable based on lack of written description, anticipation by Bruning, or obviousness over Bruning and Kabel.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “lighting device.” Accordingly, we determine that the level of ordinary skill in the art is “a bachelor’s degree in electrical engineering, or similar technical field, with two years of relevant experience in the field of design and/or development of LEDs and circuits,” as Petitioner proposes and that “the field of design and/or development” would be “in the context of lighting devices” as Patent Owner proposes, in which “[a]n increase in experience could compensate for less education.” Id.; Pet. 24 (citing Ex. 1002 ¶ 46).” slip op. at 15

    • Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalDisclaimer foundDecided for patent owner

      “theoretically fall under the “or greater” portion of the amended claim limitation “forward voltage of 6V or greater,” Applicant distinguished Colby on the basis that the 120V AC voltage from a wall outlet is not “the minimum voltage difference required between the anode and cathode of the LEDs in the claimed circuit to allow current to flow through the LEDs.” See Ex. 1023, 9 (emphasis added). Applicant’s argument specifically identifies the claim language at issue––“forward voltage of 6V or greater”––and specifically states that it is not disclosed because Colby does not disclose the minimum voltage and instead, discloses something else, something larger–– 120V AC voltage. Accordingly, we conclude that Applicant disclaimed any voltage that is more than “the minimum voltage difference required between the anode and cathode of the LEDs in the claimed circuit to allow current to flow through the LEDs” from the scope of “forward voltage.”” slip op. at 25

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

      “4. 35 U.S.C. § 112(a) With respect to the written description requirement, we are persuaded” slip op. at 32

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

      “Basis § Unpatentable Unpatentable Lack of written description, 3, 10, 17 112(a) 3, 10, 17 Lack of enablement 3, 10, 17 112(b) Indefiniteness 3, 10, 17 Lack of written description, 4, 11, 18 112(a) 4, 11, 18 Lack of enablement 4, 11, 18 112(b) indefiniteness 4, 11, 18” slip op. at 77

    Patent outcomesUS 10,932,341 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham · Nautilus
    Patents in suitUS 10,932,341
  • PTAB · May 5, 2023 · IPR2022-00098 · APJ Arthur M Peslak · IPR · Final written decision

    Claims 1, 3, and 4 are unpatentable as obvious over the stated combinations; claim 2 was not shown unpatentable because the driver was not shown configured to receive the rectifier’s forward voltages.

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

      “We agree with Patent Owner that a person of ordinary skill in the art would have had experience in LED devices. For this reason, we apply Patent Owner’s proposed level of ordinary skill in the art because it comports with the level of skill reflected in the ’149 patent and the prior art of record. However, if we were to apply Petitioner’s proposed level of skill, our Decision would not be affected.” slip op. at 9

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

      “Upon review of the entire record, we determine that no claim terms require express construction. 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’”) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 10

    • Expert testimonyPetitioner expert creditedPatent owner expert discountedMixed

      “Dr. Ducharme’s testimony that “the spacing of the chips in Zhang would not likely be so close as to create overheating issues” (Ex. 2002 ¶ 111) is unsupported by any disclosure of the actual spacing of Zhang’s chips. Consequently, his testimony that there would be no overheating concerns in Zhang due to the spacing of the chips is entitled to little, if any, weight. Dr. Ducharme further testifies that the components of Zhang’s driver “could easily increase the temperature of the LED 19 chips on the circuit board, which can cause LEDs to generate less illumination, burn out and otherwise adversely affect their performance.” Ex. 2002 ¶ 126. Dr. Ducharme further testifies that “[i]t is well-known that excessive operational temperatures can reduce the illumination provided by the LEDs, can decrease the operational lifetime of the LEDs, and if the temperature is sufficiently high, it can cause LED junction failure and a burnt-out LED.” Id. We agree with this testimony, which as discussed below, is consistent with Salam. Dr. Ducharme’s testimony concerning overheating issues caused by the driver components contradicts Patent Owner’s ’s contention that there would not be “an overheating issue with Zhang’s LED exit sign circuit in Figure 2.1.” PO Resp. 30. Regardless of whether Zhang’s LEDs in Figure 2.1 have a heat problem or not, Salam teaches the advantages of using a heat sink. Salam teaches that a heat sink will result in a higher efficiency of the LEDs and improved life. Ex. 1006, 16:38–43. The Federal Circuit, in DyStar Textilfarben GmBH & Co v. C.H. Patrick Co., 464 F.3d 1356 (Fed. Cir. 2006), stated that “the desire to enhance commercial opportunities by improving a product or process is universal–and even common-sensical . . . the proper question is whether the ordinary artisan possesses the knowledge and skills rendering him capable of combining the prior art references.” Id. at 1368. Dr. Ducharme testified that a person of ordinary skill in the art “would have an understanding of the generation of heat and using a heat sink to remove unwanted heat from electronics and LED lighting devices.” Ex. 1102, 23:18–24:3. Dr. Ducharme’s testimony is consistent with Petitioner’s contention that the combination of Zhang and Salam “would have been a straightforward combination of known components and technologies, according to known methods, to produce the predictable result of reducing/ mitigating heat effects in a circuit.” Pet. 17 (citing Ex. 1002 ¶ 106). Patent Owner next contends it would be extremely burdensome and costly to modify Zhang to add a heat sink layer because “each of the multiple chips mounted and epoxied to Zhang’s circuit board in the exit sign would have to be modified.” PO Resp. 30 (citing Ex. 2002 ¶ 112). Dr. Ducharme’s testimony repeats the Patent Owner Response verbatim and is entitled to little, if any, weight. Ex. 2002 ¶ 112. Nonetheless, this contention is unavailing because it is based on Patent Owner’s bodily incorporation of Zhang and Salam. Patent Owner next contends that a person of ordinary skill in the art” slip op. at 27

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

      “Regardless of whether Zhang’s LEDs in Figure 2.1 have a heat problem or not, Salam teaches the advantages of using a heat sink. Salam teaches that a heat sink will result in a higher efficiency of the LEDs and improved life. Ex. 1006, 16:38–43. The Federal Circuit, in DyStar Textilfarben GmBH & Co v. C.H. Patrick Co., 464 F.3d 1356 (Fed. Cir. 2006), stated that “the desire to enhance commercial opportunities by improving a product or process is universal–and even common-sensical . . . the proper question is whether the ordinary artisan possesses the knowledge and skills rendering him capable of combining the prior art references.” Id. at 1368. Dr. Ducharme testified that a person of ordinary skill in the art “would have an understanding of the generation of heat and using a heat sink to remove unwanted heat from electronics and LED lighting devices.” Ex. 1102, 23:18–24:3. Dr. Ducharme’s testimony is consistent with Petitioner’s contention that the combination of Zhang and Salam “would have been a straightforward combination of known components and technologies, according to known methods, to produce the predictable result of reducing/ mitigating heat effects in a circuit.” Pet. 17 (citing Ex. 1002 ¶ 106).” slip op. at 27

    Patent outcomesUS 10,517,149 mixed
    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 10,517,149
  • PTAB · Apr 4, 2023 · IPR2021-01565 · APJ Robert A Pollock · IPR · Final written decision

    Claims 1–24 are unpatentable: claims 1–10, 12–22, and 24 as anticipated by Kaiser, and claims 1–24 as obvious under the listed grounds.

    RulingsFinal written decision
    • Skill levelSkill level board ownDecided for petitioner

      “Considering argument and evidence of record, we define a person of ordinary skill in the art as a member of a multidisciplinary team consisting of at least (1) a person (“Engineer POSA”) with either (a) a bachelor’s or master’s degree in mechanical engineering, biomedical engineering or a similar field, as well as two or more years of work experience with catheters or similar medical devices, or (b) a Ph.D. in mechanical or biomedical engineering, or in a similar field; working with (2) a person with an M.D. or analogous degree and five or more years of work experience in interventional cardiology, hemodynamics or a similar discipline (“Clinician POSA”); or an Engineer POSA receiving assistance from a Clinician POSA; or a Clinician POSA receiving assistance from an Engineering POSA; or a single person with the qualifications of both an Engineer POSA and a Clinician POSA. With respect to the parties’ proffered declarants, the record before us demonstrates that Dr. Day and Dr. Garcia are individually well-qualified to opine as to the perspective of an Engineer POSA and a Clinician POSA, respectively; and collectively qualified to opine from the perspective of one of ordinary skill in the art as to all aspects of the claimed invention and relevant prior art. See, e.g., Ex. 1002 ¶¶ 3–15; Ex. 1003 (Dr. Day’s curriculum vitae); Ex. 1004 ¶¶ 4–15; Ex. 1005 (Dr. Garcia’s curriculum vitae). With respect to Patent Owner’s declarant, Dr. Brecker’s experience and credentials as an interventional cardiologist amply qualify him to speak to the perspective of one of ordinary skill in the art as a Clinician POSA. See Ex. 2005 ¶¶ 4–15, Exhibit A. But because there is no evidence that he is an Engineering POSA, or receiving assistance from an Engineering POSA, we accord less weight to his opinions as they relate to the province of an Engineer POSA. See Kyocera Senco Indus. Tools Inc. v. ITC, 22 F.4th 1369, 1377–78 (Fed. Cir. 2022) (holding that “to be qualified to offer expert testimony on issues from the vantage point of an ordinarily skilled artisan in a patent case, an expert must at minimum possess ordinary skill in the art”). C.” slip op. at 32

    • Expert testimonyPetitioner expert creditedPatent owner expert discountedMixed

      “demonstrates that Dr. Day and Dr. Garcia are individually well-qualified to opine as to the perspective of an Engineer POSA and a Clinician POSA, respectively; and collectively qualified to opine from the perspective of one of ordinary skill in the art as to all aspects of the claimed invention and relevant prior art. See, e.g., Ex. 1002 ¶¶ 3–15; Ex. 1003 (Dr. Day’s curriculum vitae); Ex. 1004 ¶¶ 4–15; Ex. 1005 (Dr. Garcia’s curriculum vitae). With respect to Patent Owner’s declarant, Dr. Brecker’s experience and credentials as an interventional cardiologist amply qualify him to speak to the perspective of one of ordinary skill in the art as a Clinician POSA. See Ex. 2005 ¶¶ 4–15, Exhibit A. But because there is no evidence that he is an Engineering POSA, or receiving assistance from an Engineering POSA, we accord less weight to his opinions as they relate to the province of an Engineer POSA. See Kyocera Senco Indus. Tools Inc. v. ITC, 22 F.4th 1369, 1377–78 (Fed. Cir. 2022) (holding that “to be qualified to offer expert testimony on issues from the vantage point of an ordinarily skilled artisan in a patent case, an expert must at minimum possess ordinary skill in the art”). C.” slip op. at 32

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

      “activating and adjusting restrictors based on pressure readings to achieve and then maintain target venous blood pressures.” Pet. Sup. Reply 2 (citing Ex. 1001, 15:33–36, 15:36–16:42, Fig. 11A). Implicit in the above analysis, and as expressly discussed at pages 11–12 of the Reply, which we adopt, we understand “maintaining” to refer to keeping intravascular pressure at a target level or range, which may be lower than a normal body pressure. Cf. POR 31–32 (Patent Owner’s argument that “maintaining” is limited to non-hypotensive (i.e., substantially normal) systemic pressure). In view of the above, we adopt and apply Petitioner’s proposed construction of “maintaining intravascular pressure,” to mean “maintaining pressure within blood vessels or a blood vessel.” Our construction is not limited to maintaining a physiologically normal systemic pressure, and encompasses maintaining regions of low pressure in portions of the venous system between occlusion devices, or in the vicinity of one or more occlusion devices. We need not further define the meets and bounds of this term to resolve any dispute between the parties or decide the merits of Petitioner’s challenge. D.” slip op. at 44

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

      “Although Kaiser exemplifies in detail a method involving IVC occlusion, its disclosure makes clear that the method is also applicable to the SVC. See, e.g., Ex. 1007, 6:60–64 (“the adjustable component may create a pressure gradient by . . . adjusting blood flow impedance through the superior vena cava”), 5:64–6:2 (disclosing “systems and methods may be provided to create a pressure differential” using “balloons . . . to increase a pressure drop through the . . . superior vena cava”), Claim 5 (reciting a “flow impedance device implantable within a patient’s inferior vena cava”), Claim 17 (“The method of claim 10, wherein the body lumen within which the adjustable component is positioned is . . . a superior vena cava.”), 6:31–36 (positioning pressure sensor in the superior vena cava); see also Ex. 1010, 19–22 (claims of provisional application directed to reducing blood flow through the superior vena cava); see also Pet. 29–34, 36–39; Reply 14–16; Ex. 1002 ¶¶ 152–153, 156–159, 165, 167–176 (Dr. Day’s testimony regarding the SVC positioning elements). Considering the arguments and evidence of record, including our own reading of Kaiser (see supra Section I.I.1), we find that Kaiser expressly discloses the contested element of Ground 1 relating to use of the restrictor in the SVC.” slip op. at 47

    Patent outcomesUS 10,639,460 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 10,639,460
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