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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
  • PTAB · May 16, 2025 · IPR2024-00215 · APJ Jason M Repko · IPR · Final written decision

    Claims 1–10 are unpatentable as obvious over Foster and Hayhurst; the Board did not reach the anticipation and obviousness grounds based on Orsini.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “had at least a bachelor’s degree in computer science, computer engineering, or a related field, with three years of experience in the area of securing data from unauthorized access or use.” Pet. 6 (citing Ex. 1003 ¶¶ 37–38). Petitioner also asserts that a “higher level of education may substitute for less experience.” Id. 2 Available at https://www.uspto.gov/TrialPracticeGuideConsolidated. Patent Owner submitted the Declaration of Dr. Rubin in support of its Response, and in that Declaration, Dr. Rubin accepted Petitioner’s definition. Ex. 2033 ¶¶ 20–21. For the reasons given, we apply the same level of ordinary skill in the art that we did in the Institution Decision. Inst. Dec. 4.” slip op. at 6

    • Expert testimonyPetitioner expert creditedPatent owner expert discountedMixed

      “See Section II.C.3.a.ii supra. Although Dr. Rubin calls Hayhurst’s security benefits “ancillary” (Ex. 2033 ¶¶ 108–109, quoted in PO Resp. 40), this does not align with Hayhurst (see Ex. 1007 ¶¶ 2, 7, 8, 21). For example, Hayhurst describes the security measures in the Technical Field section (id. ¶ 2) and the Summary of the Invention section (id. ¶¶ 7, 8). Hayhurst also discusses piracy deterrence in both the Summary of the Invention section (id. ¶ 8) and the invention’s detailed description (id. ¶ 21). Because Dr. Rubin does not give sufficient weight to Hayhurst’s discussion of piracy deterrence and security, we do not credit Dr. Rubin’s testimony on this issue. See Ex. 2033 ¶¶ 108–109. Thus, we agree with Petitioner that Hayhurst is reasonably pertinent to the network-security problem that the inventors were trying to solve. See Reply 5–6.” slip op. at 15

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

      “Neither party explicitly proposed constructions during trial, and we do not see the need for construing any terms in this Decision.” slip op. at 8

    • Obviousness (§103) › Analogous artAnalogous artDecided for petitioner

      “3. Claim 1 a. Analogous Art “To be considered within the prior art for purposes of the obviousness analysis, a reference must be analogous.” Circuit Check Inc. v. QXQ Inc., 795 F.3d 1331, 1335 (Fed. Cir. 2015) (citing Wang Lab. v. Toshiba Corp., 993 F.2d 858, 864 (Fed. Cir. 1993)). “Two separate tests define the scope of analogous prior art: (1) whether the art is from the same field of endeavor, regardless of the problem addressed and, (2) if the reference is not within the pertinent to the particular problem with which the inventor is involved.” Sanofi-Aventis Deutschland Gmbh v. Mylan Pharms. Inc., 66 F.4th 1373, 1377 (Fed. Cir. 2023) (quoting In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004) (citations omitted)).” slip op. at 9

    Patent outcomesUS 10,452,854 unpatentable
    Claim construction§ 103 obviousnesscites Phillips
    Patents in suitUS 10,452,854
  • 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 23, 2023 · IPR2023-00698 · APJ Thomas L Giannetti · IPR · Institution

    The Board instituted review of claims 7–11, 13, and 19–21 on all asserted grounds, finding a reasonable likelihood of prevailing for claims 11 and 13.

    RulingsInstitution decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

      “Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless the information presented in the petition “shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” For the reasons stated below, we determine that Petitioner has established a reasonable likelihood that it would prevail with respect to at least one claim. We, therefore, institute inter partes review as to all of the challenged claims of the ’202 patent and all of the asserted grounds of unpatentability.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “The two proposals are materially similar in the education requirement, but differ marginally in professional experience required (three versus five years). See supra. While we are persuaded, on the present record, that both Petitioner’s and Patent Owner’s proposals are consistent with the problems Petitioner’s proposal is a better reflection of the level of skill in the prior art, and we therefore adopt it for this decision. Our decision would not change, however, if we had applied Patent Owner’s proposed level of ordinary skill.” slip op. at 12

    • BurdenMixed

      “Figure 6 of Rauhala has been annotated by Patent Owner to show that the parallel connection (outlined in red) including resistors R1, R2. R3 and switches ka, kb is outside the signal path (highlighted in yellow) through differential amplifier 61. Prelim. Resp. 38. Petitioner identifies R1, R2, R3 and switches ka and kb as the claimed variable impedance. See, e.g., Pet. 39–41. The Petition (and the supporting Baker Declaration) do not explain adequately how, under this interpretation by Petitioner and its expert, Rauhala meets the adjusting an impedance “in the signal path” limitation. See Prelim. Resp. 39–41. For the reasons given, therefore, even if we were to disagree with Patent Owner’s construction of “impedance,” we agree with Patent Owner that Petitioner fails to demonstrate sufficiently that Rauhala meets the limitation in claims 7 and 19 requiring “dynamically adjusting one or more of an impedance . . . in the [receiver] signal path.” For the reasons given, we determine that Petitioner has demonstrated a reasonable likelihood of prevailing on its challenge to claims 11 and 13 as anticipated by Rauhala. We further determine that Petitioner has not demonstrated a reasonable likelihood of prevailing on its challenge to claims 7 and 19 as anticipated by Rauhala.” slip op. at 26

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

      “We disagree. Noting in the language of the claims requires that these method steps be performed by separate components, or that these method steps “provide two different channel indications at once” (Prelim. Resp. 38), only that they be performed as stated in the claim. In that respect, this case is distinguished from In re Robertson, where the Federal Circuit determined that the “third fastening means” required by the claims was not inherently disclosed by the prior art. Robertson, 169 F.3d at 745 (“The [prior art] patent does not expressly include a third fastening means for disposal of the diaper, as claim 76 requires.”). In further contrast to this case, Robertson addressed mechanical elements of a product (fasteners for disposable diaper), not steps in a process. More pertinent to our facts is the Federal Circuit’s decision in Microsoft Corporation v. Uniloc, 2017 LLC, No. 2021- 2039, 2022 WL 11531235 (Fed. Cir. Oct. 20, 2022), that addresses steps in a method claim. Reversing the Board’s determination that a petitioner had 6 See Ex. 1001, 14:5–6 (claim 7), 14:41–42 (claim 11), 15:18–19 (claim 13), and 17:28–29 (claim 19). Circuit concluded that the Board had misconstrued the claims to require separate acts: We agree with [petitioner] that the Board misconstrued the claims to require that the comparing and determining step are performed by two separate acts in a certain order. Nothing in the intrinsic record requires such a narrow construction, and neither party presented this construction to the Board. Without any such evidence, we decline to impose such a narrow claim construction. Microsoft Corp., 2022 WL 11531235, at *3 (citation and footnote omitted). We find that at this stage, Petitioner has made a sufficient showing that this limitation is met by Rauhala. Pet. 31–33; Baker Decl. ¶¶ 111–114.” slip op. at 22

    § 102 anticipation§ 103 obviousnesscites Graham
    Patents in suitUS 10,524,202
  • 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 · Apr 10, 2023 · IPR2021-01598 · APJ Thomas L Giannetti · IPR · Final written decision

    Claims 1–9 and 11–20 are unpatentable as obvious over either asserted combination; the motion to amend is granted for substitute claims 29, 31, and 32.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Prelim. Resp. 5. At the institution stage, we adopted Petitioner’s more general formulation, with a qualification. We stated “[w]e would also expect a person of ordinary skill to also have at least some experience in wireless cellular network protocols, as suggested by Patent Owner.” Institution Dec. 16. We reasoned that our review of the ’637 patent and the cited prior art does not suggest that specific experience with data privacy policies and protection models would be required, given the focus of the ’637 patent on more general principles of cellular communications and signaling. Id. However, we observed that the arguments presented by the parties did not depend on the definition of the person or ordinary skill, and, therefore, our decision would be the same under either formulation. Id. at 16–17.” slip op. at 10

    • Expert testimonyPetitioner expert creditedDecided for petitioner

      “Resp. 12–14. The fact that Kalanick may not “disclose any problem” arising from the possibility of two passengers in the same area having the same signal does not prove a problem did not exist or that a person of ordinary skill would not be motivated to improve upon the solution for it. See Pet. Reply 5–6. Similarly, we are not persuaded by Patent Owner’s argument that there would be no reasonable expectation of success based on Kemler’s disclosure of a server farm. PO Resp. 24 (“The immense expense and complexity of operating a server ‘farm’ would be a reason to avoid Kemler’s teachings.”). Testimony from Mr. Williams establishes the advantages of such systems. Pet. Reply 7 (citing Williams I Decl. ¶¶ 124); Williams Dep. 82:1–88:25, 92:13–93:1; Williams III Decl. ¶¶ 34–35.5” slip op. at 33

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

      “We find that the Petition and supporting expert testimony sufficiently demonstrate that a person of ordinary skill would have combined the teachings of Kemler and Kalanick with a reasonable expectation of success. Pet. 21–27; Williams I Decl. ¶¶ 113–125; Williams III Decl. ¶¶ 5–17. In addition to the reasons given supra, Petitioner explains that Kalanick’s “on-” slip op. at 30

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

      “The ’637 patent describes an indicator as “a ‘code’ (e.g., a text string or an alphanumeric string), an icon, or other identifier, on the display 130 and on a mobile communication device 140 associated with the user P to enable the user P to identify the vehicle that he/she has requested for a ride service.” Ex. 1001, 4:6–10. Consistent with this description in the specification, we construed the term “indicator” as a code (e.g., a text string or an alphanumeric string), an icon, or other identifier, for display to enable a match between a user/rider and a driver. Institution Dec. 20. We did not see a basis in the claims or specification for Patent Owner’s contention that a “new unique indicator” must be “actively formulate[d] . . . for each rider-driver trip while the driver is in transit.” Id. at 20 (citing Prelim. Resp. 29). Patent Owner does not address the construction of “indicator” in its Response. For the reasons given, therefore, we maintain our construction of this term. We discuss Patent Owner’s contention that a new indicator must be “actively formulated” further in connection with our consideration of the claim term “generate,” infra.” slip op. at 15

    Patent outcomesUS 9,892,637 unpatentable
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 9,892,637
  • 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
  • PTAB · Feb 7, 2023 · IPR2021-01340 · APJ David Cotta · IPR · Final written decision

    Claims 1–17 are unpatentable as obvious over Coronel and Fox because their combination teaches the claimed fault detection and process control features.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedOther

      “Petitioner’s proposal appears to be generally consistent with the level of skill reflected in the specification and in 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, 8 163 (Fed. Cir. 1985)). And we agree with Patent Owner that “additional education can compensate for less work experience and vice versa.” Accordingly, we adopt Petitioner’s proposed definition of the POSA level with the additional clarification proposed by Patent Owner.” slip op. at 8

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

      “Petitioner does not identify any claim terms that require construction. Pet. 15. Patent Owner does not dispute Petitioner’s assertion that no claim terms require construction. PO Resp. 6. We do not find it necessary to provide an express construction for any claim terms. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))); Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy’”).” slip op. at 9

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

      “In view of these teachings, we agree with Petitioner and Dr. Hatalis that “[a] POSA would have recognized that applying the teachings of Fox to the system of Coronel, . . . would have promoted the desired objective of increasing process yields by combining fault detection based on multivariate analysis of tool state data with fault detection based on data received from the monitoring equipment of Coronel.” Ex. 1002 ¶ 74; Pet. 35–36. The record supports Dr. Hatalis’s testimony that “applying the methods disclosed in Fox to the system of Coronel would have been straightforward and an application of known techniques to improve a comparable system in the same way.” Ex. 1002 ¶ 75. In this regard, the 17 record supports that multivariate analysis was known and used in the art. Id. ¶ 71 (Dr. Hatalis’s testimony, citing Ex. 1013, 56–57 (article entitled “Practical issues in the deployment of a run-to-run control system in a semiconductor manufacturing facility,” (id. at 52) teaching that “FDC [fault detection and classification] can take many forms in ProcessWORKS, from traditional process monitoring techniques such as statistical process control (SPC) to advanced multivariate analysis based on trace data”)); see also Ex. 1005, 4:7–9 (“The use of the Hotelling’s T2 multivariate analysis is a statistical method well known in the prior art.”). In addition, as Dr. Hatalis explains, “because the methods described in Fox are executed using a computer, they would have been readily applied to the computer, database, and supervisor of Coronel.” Ex. 1002 ¶ 76. Further, “performing fault detection by using T2 values . . . had been previously implemented on an AME 5000 system, which is the same system referenced in Coronel,” and “Fox implements the T2 analysis with the same kind of tool used in Coronel, a plasma etcher.” Id. ¶ 78 (Dr. Hatalis’s testimony). In view of the evidence that multivariate analysis was well-known and in view of the similarities between Coronel and Fox, we agree with Petitioner that a POSA would reasonably have expected success in combining Coronel and Fox. As Dr. Hatalis explains, modifying Coronel’s method to include Fox’s multivariate analysis would have “simply involved adapting the software in the supervisor of Coronel, which already has computing capabilities and storing in its database the T2 values and UCL and LCL boundary values as taught by Fox.” Id. ¶ 83. And we find no evidence that applying Fox’s algorithms or methods to Coronel’s computer would” slip op. at 17

    • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

      “Patent Owner cites the testimony of Mr. Humphrey to support that translating between the different protocols of Coronel and Fox would have brought “an additional degree complexity to the system and compromised its ability to efficiently report faults.” Ex. 2040 ¶ 70. However, the persuasiveness of Mr. Humphrey’s testimony is diminished by the absence of explanation and by the absence of citation to supporting evidence. See In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he 26 Board is entitled to weigh the declarations and conclude that the lack of factual corroborations warrants discounting the opinions expressed in the declarations.”); 37 C.F.R. § 42.65 (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”). Although Mr. Humphrey testifies that translation adds complexity, the evidence of record supports that the translation technique on which Petitioner relies was routine. Ex. 1002 ¶ 90 (Dr. Hatalis testimony that “[i]t was well-known in the art how to transmit data in ASCII format or as numeric data via the SECS II communications protocol”); Ex. 1001, 5:26–33 (explaining that translation between the communication protocol used by “equipment interface 110” and “Common Object Request Broker Architecture Interface Definition Language (COBRAIDL)” is “well known to those of ordinary skill in the art” and, thus will “not be discussed . . . to avoid unnecessarily obscuring the present invention”); see also Ex. 1018, 172 (article cited by Dr. Hatalis describing transmission of ASCII data over SECS II protocol). To the extent Mr. Humphrey’s testimony that translation adds “an additional degree complexity to the system and compromised its ability to efficiently report faults” contradicts Dr. Hatalis’s testimony, we credit Dr. Hatalis over Mr. Humphrey. Moreover, as discussed above, we credit Dr. Hatalis’s testimony that a POSA would have understood that it was necessary to translate from ASCII to SECS II in order to transmit tool state data to the supervisor for fault detection. Ex. 1002 ¶ 90. Given the evidence that the asserted translation was both necessary and routine, we find that the potential for delays that 27” slip op. at 26

    Patent outcomesUS 6,725,402 unpatentable
    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 6,725,402
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