• Axion Biosystems, Inc. v. Agilent Technologies, Inc.No claims unpatentable
  PTAB · Feb 2, 2026 · IPR2024-01467 · APJ David Cotta · IPR · Final written decision

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

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

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

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

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

  • Expert testimonyPetitioner expert discountedDecided for patent owner

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

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

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

  Patent outcomesUS 11,906,508 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,906,508
• Viant Techology LLC v. Intent Iq, LLCAll claims unpatentable
  PTAB · Oct 14, 2025 · IPR2024-00422 · APJ Scott B Howard · IPR · Final written decision

  The Board held claims 1–152 unpatentable based on the asserted obviousness grounds and struck Section II of Petitioner’s reply claim-construction brief.

  RulingsFinal written decision

  • BurdenFwd all claims unpatentableUnpatentable

    “Decision issues pursuant to 35 U.S.C. § 318(a). For the reasons that follow, we determine that Petitioner has shown by a preponderance of the evidence that the challenged claims are unpatentable.” slip op. at 2

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

    “1. “Contracted to Display a TV Ad Petitioner argues that the term means “contracted to display any form” slip op. at 14

  • Strike new argumentGranted

    “FURTHER ORDERED that Section II of Petitioner’s Reply Claim Construction Brief is stricken from the record; and” slip op. at 80

  Patent outcomesUS 7,861,260 unpatentable
  Claim constructioncites Phillips · KSR · Graham
  Patents in suitUS 7,861,260
• Viant Technology, Inc. v. Intent Iq, LLCAll claims unpatentable
  PTAB · Oct 14, 2025 · IPR2025-00128 · APJ Scott B Howard · IPR · Final written decision

  The Board held claims 1–152 unpatentable based on obviousness grounds and struck Section II of Petitioner’s Reply Claim Construction Brief.

  RulingsFinal written decision

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

    “1. “Contracted to Display a TV Ad Petitioner argues that the term means “contracted to display any form” slip op. at 14

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

    “d) Conclusion Regarding Claim 1 For the reasons set forth above, Petitioner has demonstrated by a preponderance of the evidence that the subject matter of claim 1 would have been obvious over Baig, Costa, and Zwicky. 5. Analysis of Claims 2–5, 7–9, 12, 15, 17, 21, 22, 24, 26–28, 31, 32, 34, 37, 42, 44, 53, 54–58, 61, 62, 69, 71–80, 83, 84, 86–88, 91, 94, 96, 100, 101, 103, 106, 116–119, 122, 125, 128, 135, 137– 145, 147, 148, 151, and 152 Petitioner argues that the combination of Baig, Costa, and Zwicky teaches the limitations recited in claims 2–5, 7–9, 12, 15, 17, 21, 22, 24, 26–28, 31, 32, 34, 37, 42, 44, 53, 54–58, 61, 62, 69, 71–80, 83, 84, 86–88, 91, 94, 96, 100, 101, 103, 106, 116–119, 122, 125, 128, 135, 137–145, 147, 148, 151, and 152 and that a person having ordinary skill in the art would have combined the teachings with a reasonable expectation of success. Pet. 28–60; 422Pet. 29–51. Petitioner’s arguments are supported by citations to the prior art and the testimony of Mr. Lett. See Pet. 28–60; 422Pet. 29–51. We have reviewed Petitioner’s arguments and evidence, agree with them, and, therefore, adopt Petitioner’s arguments and evidence as our own. Patent Owner does not separately address those claims. See PO Resp.; 422PO Resp. Instead, Patent Owner only relies on the arguments discussed above for claim 1. See PO Resp. 13–16; 422PO Resp. 13–16. For the same reason as discussed above in Section II.D.4(b), we do not agree with Patent Owner’s arguments regarding the reason to combine the references. Accordingly, Petitioner has shown by a preponderance of the evidence” slip op. at 50

  • Strike new argumentNew argument disregardedGranted

    “F. Sua Sponte Striking Section II of Petitioner’s Reply Claim Construction Brief Our order allowing post-hearing claim construction briefing stated that “[t]he parties may not address any issues besides claim construction.” Paper 38, 1. Despite that order, Section II of Petitioner’s Reply Claim Construction Brief addresses obviousness under Patent Owner’s proposed construction. See Pet. Reply Post-hearing Br. 2–3 (Titled: “The Petition’s Obviousness Theory Renders Claims 121 and 146 Obvious Even Under Patent Owner’s Improper Construction.”). Because the section is in violation of our order, we sua sponte strike that section. See 37 C.F.R. § 42.12.” slip op. at 74

  Patent outcomesUS 7,861,260 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 7,861,260
• Viant Techology LLC v. Intent Iq, LLCAll claims unpatentable
  PTAB · Oct 14, 2025 · IPR2024-00421 · APJ Scott B Howard · IPR · Final written decision

  The Board held claims 1–152 unpatentable over the asserted prior art and struck Section II of Petitioner’s reply claim construction brief.

  RulingsFinal written decision

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

    “d) Conclusion Regarding Claim 1 For the reasons set forth above, Petitioner has demonstrated by a” slip op. at 50

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

    “1. “Contracted to Display a TV Ad Petitioner argues that the term means “contracted to display any form” slip op. at 14

  • Strike new argumentGranted

    “F. Sua Sponte Striking Section II of Petitioner’s Reply Claim Construction Brief Our order allowing post-hearing claim construction briefing stated that “[t]he parties may not address any issues besides claim construction.” Paper 38, 1. Despite that order, Section II of Petitioner’s Reply Claim Construction Brief addresses obviousness under Patent Owner’s proposed construction. See Pet. Reply Post-hearing Br. 2–3 (Titled: “The Petition’s Obviousness Theory Renders Claims 121 and 146 Obvious Even Under Patent Owner’s Improper Construction.”). Because the section is in violation of our order, we sua sponte strike that section. See 37 C.F.R. § 42.12.” slip op. at 74

  Patent outcomesUS 7,861,260 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 7,861,260
• 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
• 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
• Eli Lilly And Company v. Teva Pharmaceuticals International GmbHAll claims unpatentable
  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
• Eli Lilly And Company v. Teva Pharmaceuticals International GmbHAll claims unpatentable
  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
• Eli Lilly And Company v. Teva Pharmaceuticals International GmbHAll claims unpatentable
  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
• Synthego Corporation v. Agilent Technologies, Inc.All claims unpatentable
  PTAB · May 17, 2023 · IPR2022-00403 · APJ Michael A Valek · IPR · Final written decision

  Claims 1–33 are unpatentable: claims 1–5, 8–21, and 24–33 are anticipated by Pioneer Hi-Bred; the remaining claims are obvious over the stated combinations.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

    “Patent Owner agrees that a POSA would have this educational level. Resp. 23. Patent Owner “also agrees that a POSA would have knowledge of prior art RNA based gene regulating technologies, but disagrees that the teachings of those technologies are relevant in the manner that Dr. Furneaux [and Petitioner] attempt[] to apply them” in the Petition’s grounds. Id. at 23– 24. We find the parties’ agreed understanding of the level of ordinary skill in the art to be supported by the record and apply that description in our analysis herein. To the extent the parties disagree regarding the application of a POSA’s general knowledge of nucleic acids and related prior art techniques to the Petition’s grounds, such disputes are addressed in our analysis below.” slip op. at 9

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

    “Independent claims 1 and 19 recite a guide RNA or crRNA molecule having “gRNA functionality comprising associating with a Cas protein and targeting the gRNA:Cas protein complex to the target sequence.” Ex. 1001, 257:42–44, 259:5–7. This claim language makes clear that the recited “gRNA functionality” requires a molecule that can: (1) associate with a Cas protein, and (2) target that complex to a target sequence in a polynucleotide. To the extent Petitioner suggests that a gRNA “need only bind to the Cas protein” to have “gRNA functionality,” we disagree because the claims additionally recite the above-quoted targeting functionality. See Reply 16 (emphasis added). At the same time, we agree with Petitioner that “a gRNA need not cleave the target DNA” to have the claimed “gRNA functionality.” Reply 16. The Specification defines “gRNA functionality” as “one or more functions of naturally occurring guide RNA, such as associating with a Cas protein, or a function performed by the guide RNA in association with a Cas protein” and lists various gRNA functions, e.g., “associating,” “targeting,” “binding,” “nicking,” and “cleaving,” that may be present “in certain embodiments” of the invention. Ex. 1001, 6:56–7:1. However, as noted above, the claims recite “gRNA functionality comprising” only the associating and targeting functions. Thus, while a molecule may have additional functions such as cleaving a target polynucleotide, it need only exhibit the recited “associating” and “targeting” functions to have the “gRNA functionality” in claims 1 and 19. Our determination that “gRNA functionality” requires the recited “associating” and “targeting” functions, but not additional, unrecited functions such as cleaving, is also consistent with the parties’ position that the claim language has its plain and ordinary meaning. See Pet. 17; Resp. 24. The parties do not dispute the construction of any other terms, nor do we discern that any further claim construction is necessary to resolve the issues in this proceeding. See Nidec Motor Corp. v. Zhongshan Broad OceanMotor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (explaining that it is only necessary to “construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 10

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

    “established that “anticipation does not require actual performance of suggestions in a disclosure.” Novo Nordisk Pharms., Inc. v. Bio-Tech. Gen. Corp., 424 F.3d 1347, 1355 (Fed. Cir. 2005); see also In re Donohue, 766 F.2d 531, 533 (Fed. Cir. 1985). Moreover, the Petition need not assert that “gRNA functionality” is inherently disclosed because Petitioner has shown that Pioneer Hi-Bred’s expressly discloses this limitation. Pet. 25–26 (citing evidence). There is no additional requirement that this express disclosure be backed by test data in order for the reference to be anticipatory. See, e.g., Novo, 424 F.3d at 1355; Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1326 (Fed. Cir. 2005) (“[P]roof of efficacy is not required in order for a reference to be enabled for purposes of anticipation.”).” slip op. at 22

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “Second, even if those sequences were truncated, the record does not support Patent Owner’s argument that a POSA would doubt that they have gRNA functionality. Patent Owner’s argument is premised on Dr. Marshall’s testimony that these sequences “are truncated to a point that would render them nonfunctional.” Ex. 2025 ¶ 200. But the references he cites do not support that position. See Ex. 2025 ¶ 202 (citing Ex. 1033 (“Fu”); Ex. 2044 (“Cencic”); and Ex. 2045 (“Mali”)). To the contrary, Fu evidences that “truncated gRNAs, with shorter regions of target complementarity <20 nucleotides in length” are functional and that truncation to 17 nt is beneficial. Ex. 1033, Abstr.; see also id. at 283 (“[W]e found that [truncated] gRNAs with 17 or 18 nucleotides of complementarity generally function efficiently at the intended target site and have improved specificities.”). Cencic and Mali likewise do not suggest that a 17 nt VT domain would lack gRNA functionality. See Ex. 2025 ¶ 202 (citing Cencic as showing “truncated gRNA tests showed that a guide sequence of only 16 nucleotides” abolished cleavage activity); Ex. 2045, Supp. Fig. 10 (“1-3 bp 5’ [gRNA] 11 Patent Owner asserts that Dr. Furneaux “adopted the definition of ‘truncated gRNAs’ as those with ‘regions of target complementarity <20 nucleotides in length” in paragraph 79 of his opening declaration. Sur-reply 8 n. 1. We disagree. The testimony in paragraph 79 refers to the particular results in Fu. See Ex. 1003 ¶ 78 (citing Ex. 1033). We see nothing there that suggests Dr. Furneaux agrees with Patent Owner’s position that any gRNA with a VT region of less than 20 nt is truncated. truncations are indeed well tolerated, but larger deletions lead to loss of activity”). Accordingly, we credit Dr. Furneaux’s testimony (see, e.g., Ex. 1003 ¶ 78, Ex. 1059 ¶¶ 73–75) over the competing testimony offered by Dr. Marshall on these points.” slip op. at 24

  Patent outcomesUS 10,900,034 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 10,900,034

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