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  • PTAB · Jun 11, 2026 · IPR2025-00115 · APJ Annette R Reimers · IPR · Final written decision

    Claims 1–4, 10, 11, 14, 17, 21, 22, 24, 26, 28–30, 32, 33, and 35 are unpatentable; claim 15 is not shown unpatentable, based on the four asserted obviousness grounds.

    RulingsFinal written decision
    • ExcludeMotion to exclude, deniedDenied

      “IV. PATENT OWNER’S MOTION TO EXCLUDE Patent Owner seeks to exclude portions of Dr. Wieselthaler’s Declaration (Exhibit 1041), portions of Mr. Crosby’s Reply Declaration (Exhibit 1042), portions of the deposition transcript of Dr. Wieselthaler (Exhibit 2028), and the exhibits “upon which that testimony is based” (Exhibits 1015, 1038, 1044, 1046, 1049, and 1050). Mot. 1. According to Patent Owner, the Motion was made “to preserve objections previously made in the record.” Id. (citations omitted). Patent Owner did not timely move to strike any of the evidence at issue as being outside the scope of reply evidence. Patent Owner asserts that because an inter partes review must be based on prior art consisting of patents or printed publications (citing 35 U.S.C. § 311(b)), the testimony of Mr. Crosby and Dr. Wieselthaler concerning “various physical devices allegedly known” to a person of ordinary skill in the art is inadmissible, along with all of the exhibits (consisting of printed materials such a journal abstracts, press releases, and papers) related to those physical devices. Id. at 3–4; see also Mot. Reply 1–4 (arguing that “devices that Petitioner’s witnesses assert were in public use prior to the claimed inventions, are not prior art that can form the basis of an inter partes review”). According to Patent Owner, Dr. Wieselthaler was unable to “link two of these physical devices to the printed prior art asserted in this [inter partes review], but those attempts fell apart during his cross examination.” Id. at 4. Patent Owner further reasons that because the evidence “cannot be the basis” of an inter partes review, it “has probable,” “is irrelevant and not admissible,” “presents substantial danger of confusing the issues, causing undue delay, and wasting time in this trial,” and “are not ‘based on sufficient facts[,] the product of reliable principles and methods[, or] ‘a reliable application of the principles and methods to the facts of the case.’” Id. at 7 (citing Fed. R. Evid. 401–403, 702) (modification in original). With regard to Exhibits 1015, 1038, 1044, 1046, 1049, and 1050, Petitioner argues, and we agree, that Patent Owner identifies no plausible legal theory for their inadmissibility based on the contention that they discuss physical devices. See Mot. Resp. 3. We also agree with Petitioner that the exhibits are not “the basis for any ground” asserted in this proceeding, and may be properly relied upon by Dr. Wieselthaler and Mr. Crosby as support for their rebuttal testimony directed to Patent Owner’s arguments disputing Petitioner’s asserted motivation to combine the prior art relied upon in the instituted grounds. See id. at 3–4. In regard to the disputed testimony of Dr. Wieselthaler and” slip op. at 80

    • Skill levelSkill level board ownOther

      “B. Level of Ordinary Skill in the Art In determining the level of ordinary skill in the art, various factors” slip op. at 14

    • Expert testimonyPetitioner expert discountedDecided for patent owner

      “‘electronics for power and control’”). According to Mr. Crosby, a person of ordinary skill in the art “would have understood based on the disclosure of this setup that these speed and motor parameters were monitored by a sensor providing feedback to the controller.” Ex. 1003 ¶ 725. Mr. Crosby identifies no support for this opinion, which we give little weight to. The mere fact that Bourque’s pump used software to control speed and motor parameters does not show that Bourque used “one or more sensors” to provide feedback signals to the external control unit. Indeed, Petitioner fails to identify any evidence that Bourque used any “sensor” to monitor “speed and motor parameters.” Mr. Crosby also states that “[e]ach of the ‘ultrasonic flow probe’ and the ‘solid-state catheter-type pressure transducer’ described in [Bourque] is a ‘sensor’ as recited in Claim 33 that provides feedback signals to the external control unit (e.g., ‘electronics for power and control’ and ‘data acquisition’).” Id. ¶¶ 581, 726. Mr. Crosby’s opinion is again unsupported by the evidence, because, as explained above, there is no teaching in Bourque that either the “ultrasonic flow probe” or the “pressure transducers” used in the “in vitro characterization” studies were part of the heart assist pump device. Based on our review and consideration of Petitioner’s arguments and evidence directed to claim 11, we find that Petitioner has not shown by a preponderance of the evidence that the asserted combination of Bourque and Wampler teaches or suggests each of the limitations of dependent claim 11. We reach the same conclusion for the same reasons with regard to claim 33.” slip op. at 48

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

      “1. “magneto coupling” Claim 1 recites, in relevant part, a second magnetic device “positioned” slip op. at 25

    Patent outcomesUS 11,674,517 mixed
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 11,674,517
  • PTAB · Jun 11, 2026 · IPR2025-00096 · APJ James A Tartal · IPR · Final written decision

    Claims 1–4, 6, 7, 10, 12, and 13 are unpatentable as obvious over Schima and Akamatsu; claim 5 was not shown unpatentable.

    RulingsFinal written decision
    • ExcludeMotion to exclude, deniedDenied

      “consequence in determining the action.” Fed. R. Evid. 401. Fed. R. Evid. 702 serves “a ‘gatekeeping role,’ the objective of which is to ensure that expert testimony admitted into evidence is both reliable and relevant.” Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356, 1360 (Fed. Cir. 2008). There is no question that the disputed testimony of Dr. Wieselthaler and Mr. Crosby is relevant to the asserted motivation to combine and reliable, only whether it becomes “not relevant” or “unreliable,” in light of limited scope upon which grounds of unpatentability may be based under 35 U.S.C. § 311(b), because the testimony is based on, or supported by, knowledge of physical devices and publications discussing physical devices. Patent Owner directs us to no support for the notion that an expert’s testimony in an inter partes review must be limited to only the prior art relied upon as grounds for unpatentability and may not take into account any knowledge of, or publications concerning, other “physical devices” that would have been known to a person of ordinary skill at the relevant time. See generally Mot.25 In sum, we find that Patent Owner has 25 Patent Owner improperly asserts for the first time in its Reply in support of the Motion that “Petitioner in this case is improperly relying on non-prior art evidence.” Mot. Reply 3. This argument was not made in the Motion, and Patent Owner fails to identify what “non-prior art evidence” it seeks to exclude. We recognize that Petitioner appears to raise the argument that “non-prior art evidence” may be relied upon by an expert, but Petitioner also fails to identify what evidence it is referring to and that argument was not responsive to any issue Patent Owner raised in the Motion. See Mot. Resp. 5. To the extent the Parties intend “non-prior art evidence” to refer to the testimony of Dr. Wieselthaler and Mr. Crosby, we view the issue as pertaining to the weight afforded that testimony, in light of the supporting evidence relied upon, rather than one of admissibility. for the exclusion of evidence in this proceeding and deny the Motion.” slip op. at 83

    • Skill levelOther

      “B. Level of Ordinary Skill in the Art In determining the level of ordinary skill in the art, various factors” slip op. at 10

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Other

      “D. Claim Construction In this proceeding we construe claims using the same claim” slip op. at 20

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

      “5. Rationale in Support of Asserted Combination Petitioner shows, and there is no dispute, that Bourque and Wampler” slip op. at 48

    Patent outcomesUS 11,351,356 mixed
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 11,351,356
  • PTAB · Jun 10, 2026 · IPR2025-00114 · APJ Annette R Reimers · IPR · Final written decision

    Claims 1, 2, 4, 5, 7, 8, 11, 12, 14–16, 18, and 19 are unpatentable under §103; claim 20 was not shown unpatentable.

    RulingsFinal written decision
    • Expert testimonyDenied

      “IV. PATENT OWNER’S MOTION TO EXCLUDE Patent Owner seeks to exclude portions of Dr. Wieselthaler’s Declaration (Exhibit 1041), portions of Mr. Crosby’s Reply Declaration (Exhibit 1042), portions of the deposition transcript of Dr. Wieselthaler (Exhibit 2028), and the exhibits “upon which that testimony is based” (Exhibits 1015, 1038, 1044, 1046, 1049, and 1050). Mot. 1. According to Patent Owner, the Motion was made “to preserve objections previously made in the record.” Id. (citations omitted). Patent Owner did not timely move to strike any of the evidence at issue as being outside the scope of reply evidence. Patent Owner asserts that because an inter partes review must be based on prior art consisting of patents or printed publications (citing 35 U.S.C. § 311(b)), the testimony of Mr. Crosby and Dr. Wieselthaler concerning “various physical devices allegedly known” to a person of ordinary skill in the art is inadmissible, along with all of the exhibits (consisting of printed materials such a journal abstracts, press releases, and papers) related to those physical devices. Id. at 3–4; see also Mot. Reply 1–4 (arguing that “devices that Petitioner’s witnesses assert were the basis of an inter partes review”). According to Patent Owner, Dr. Wieselthaler was unable to “link two of these physical devices to the printed prior art asserted in this [inter partes review], but those attempts fell apart during his cross examination.” Id. at 4. Patent Owner further reasons that because the evidence “cannot be the basis” of an inter partes review, it “has no tendency to make any fact of consequence in this trial more or less probable,” “is irrelevant and not admissible,” “presents substantial danger of confusing the issues, causing undue delay, and wasting time in this trial,” and “are not ‘based on sufficient facts[,] the product of reliable principles and methods[, or] ‘a reliable application of the principles and methods to the facts of the case.’” Id. at 7 (citing Fed. R. Evid. 401–403, 702) (modification in original). With regard to Exhibits 1015, 1038, 1044, 1046, 1049, and 1050, Petitioner argues, and we agree, that Patent Owner identifies no plausible legal theory for their inadmissibility based on the contention that they discuss physical devices. See Mot. Resp. 3. We also agree with Petitioner that the exhibits are not “the basis for any ground” asserted in this proceeding, and may be properly relied upon by Dr. Wieselthaler and Mr. Crosby as support for their rebuttal testimony directed to Patent Owner’s arguments disputing Petitioner’s asserted motivation to combine the prior art relied upon in the instituted grounds. See id. at 3–4. In regard to the disputed testimony of Dr. Wieselthaler and” slip op. at 77

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

      “1. “magneto coupling” Claim 1 recites, in relevant part, “a second magnetic device . . . positioned to magnetically drive rotation of the magnetically driven rotor via a magneto coupling with the first magnetic device.” Ex. 1001, 5:34–37. Claim 11 recites, in relevant part, “the second magnetic device positioned axially closer to the first magnetic device than to the magnetically driven rotor so as to magnetically drive rotation of the magnetically driven rotor relative to the one or more walls via a magneto coupling with the first magnetic device.” Id. at 6:42–48. Petitioner argues that “magneto coupling” means “a transfer of torque from one rotating permanent magnetic component to another rotating permanent magnetic component via a magnetic field.” Pet. 8–9 (citing Ex. 1003 ¶¶ 68–87). According to Petitioner, this construction is consistent with the ’879 patent, which describes “a coupling between two rotating ‘bar magnets’—a drive wheel rotates one bar magnet which causes another bar magnet (connected to a rotor) to rotate.” Id. (citing Ex. 1003 ¶¶ 54–55 (analyzing Ex. 1001, 2:28–52, 4:44–64, Fig. 2)). Patent Owner argues that “magneto coupling” should be afforded “its plain and ordinary meaning, which would encompass a magnetic coupling through both rotating magnets and the use of a rotating magnetic Owner directs us to the testimony of Mr. Leschinsky, who explains that a person of ordinary skill in the art would have understood the ’879 patent to use “magneto coupling” to generally describe “a way to couple the rotor to a drive element while sealing the two from one another and avoiding use of a direct mechanical coupling.” Ex. 2015 ¶ 67. According to Patent Owner, “Petitioner provides no recognizable basis for limiting the plain meaning of magnetic coupling to one type of magnet and excluding another type of magnet.” PO Resp. 6–7 (citing Johnson Worldwide Associates, Inc., v. Zebco Corp., 175 F.3d 985, 989–992 (Fed. Cir. 1999)). We agree with Patent Owner that Petitioner does not provide a sufficient basis for limiting the plain meaning of “magneto coupling.” That the ’879 patent describes embodiments using bar magnets does not serve to require the use of permanent magnets for the recited “magneto coupling.” See Sisvel Int’l S.A. v. Sierra Wireless, Inc., 81 F.4th 1231, 1236 (Fed. Cir. 2023) (quoting Phillips, 415 F.3d at 1323 (“[A]lthough the specification often describes very specific embodiments of the invention, we have repeatedly warned against confining the claims to those embodiments.”)). Moreover, the claim language here is not so limited. 13 Patent Owner notes that Petitioner’s grounds of unpatentability based on Wampler and Bourque depend on the disclosure only of electromagnetic drives in each reference, implying that “Petitioner does not believe its own proposed narrower construction.” PO Resp. 6; see also Pet. 8 (Petitioner alleging that in the Parallel Proceeding Patent Owner “conflates ‘magneto coupling’ . . . with a stator drive using a stationary electromagnet, instead of a rotating magnet, to rotate the rotor magnet,” and asserting that as the basis for Petitioner’s reliance on Wampler and Bourque as teaching a “magneto coupling” in this proceeding (citing Ex. 1019, 7; Ex. 1003 ¶¶ 84–87)).” slip op. at 24

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

      “reasons discussed above. See supra Section III.D.3. Accordingly, because Petitioner’s contentions are premised on an unsupported claim construction that we reject, Petitioner fails to show how Wampler teaches or suggests “a magnetically driven rotor . . . axially adjacent to a first magnet device,” as required by claims 1 and 11, as well as by claims 2, 4, 5, 7, 8, 11, 12, 14– 16, and 18–20, which depend from either claim 1 or claim 11. In its Reply, Petitioner suggests that “[u]nder [Patent Owner’s] construction from the [Patent Owner Response], Wampler also teaches or suggests this limitation,” because Patent Owner “concedes [that] ‘axially adjacent’ components ‘have” slip op. at 36

    Patent outcomesUS 11,572,879 mixed
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 11,572,879
  • Fluidmaster, Inc. v. Danco, Inc.Some claims unpatentable
    PTAB · Mar 5, 2026 · IPR2024-00634 · APJ Meredith C Petravick · IPR · Final written decision

    Claims 1, 3, 8–13, 15, 16, and 19–24 are unpatentable over Brown and Ho, with claims 16 and 19 also relying on the Quick Connection Art; the remaining challenged claims were not shown unpatentable.

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

      “Patent Owner proposes that: A [person of ordinary skill in the art (“POSITA”)] in the field to which the ’105 Patent is directed would have had at least a Bachelor of Science degree in mechanical engineering or a related field or, as a substitute, at least two years of work or” slip op. at 9

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

      “of “integrally molded with” as “molded together as a single structure.” Paper 21, 15.” slip op. at 11

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

      “Patent Owner responds that: a POSITA would not have been motivated to make the proposed modification, nor does the Petition include any analysis regarding why a POSITA would be motivated to move from a vertical extended portion to a radial extended portion. Indeed, a radial extended portion is directly counter to the stated goals of Brown (e.g., reducing noise caused by turbulence), at least insofar as it introduces another sudden directional change into the fluid flow system. PO Resp. 58–59 (citing Ex. 2013 ¶ 242).” slip op. at 32

    • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner

      “Patent Owner argues that the ’105 patent claims were “fully supported as of the filing date of at least the ’606 Application . . . March 11, 2004” because the ’606 Application discloses regulating water flow and a POSITA would know that appropriate devices for regulating water flow includes nonadjustable waterflow restrictors. PO Resp. 63–65; PO Sur-reply 26–29. Patent Owner’s argument is persuasive. The ’606 Application discloses: [W]hen the toilet fill valve 100 is open and water flows from the water inlet 103 to the water outlets 106 and into a toilet tank, an amount of water is also supplied to the bowl fill valve inlet 113 that flows through the bowl fill valve 109 and out the bowl fill valve outlet 116. By virtue of the manual setting of handle 119 of the bowl fill valve 109, the flow of water through the bowl fill valve 109 is regulated. In this manner, the flow of water is regulated so that enough water flows out of the bowl fill valve 109 to fill a toilet bowl without wasting any water down a drain. seen from the passage above, the ’606 Application discloses regulating an amount of water supplied to a toilet bowl using a valve (i.e., a water flow regulator). Ex. 2013 ¶ 288. Further, the ’606 Application states: The bowl fill valve 109 may be, for example, a ball valve, a gate valve, a globe valve, a plug valve, a diaphragm valve, a butterfly valve, a needle valve, a sliding gate, a quick turn valve, a knife valve or any other appropriate type of valve as can be appreciated by those with ordinary skill in the art.” slip op. at 42

    Patent outcomesUS 9,103,105 mixed
    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
    Patents in suitUS 9,103,105
  • Fluidmaster, Inc. v. Danco, Inc.Some claims unpatentable
    PTAB · Dec 15, 2025 · IPR2024-00633 · APJ Meredith C Petravick · IPR · Final written decision

    Claims 1, 7–15, 19, and 20 are unpatentable over Brown and Ho; claims 2–6 and 16–18 were not shown unpatentable on the asserted grounds.

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

      “Brown’s adapter tube 23 (i.e., the extended portion) does not extend radially from a longitudinal axis of valve assembly 13 (i.e., the toilet fill valve). Ex. 1021, Fig. 1. Mr. Jobin testifies that a POSITA would not be motivated to move adapter tube 23 from a vertical position to a radial position because “a radial extended portion is directly counter to the stated goals of Brown (e.g., reducing noise caused by turbulence), at least insofar system.” Ex. 2013 ¶ 251; see Ex. 1021, 1:9–62. Patent Owner’s argument is persuasive. Petitioner’s analysis and Dr. Cameron’s testimony is conclusory and does not sufficiently explain why a POSITA would be motivated to make the proposed modification to Brown. For example, Petitioner does not sufficiently explain how such a modification would result in a more compact toilet fill valve system that could be adapted to fit in more toilet tank designs. Further, neither Petitioner nor Dr. Cameron sufficiently address Mr. Jobin’s testimony regarding Brown’s desire for a quieter toilet. See Pet. Reply 23; Ex. 1036 ¶ 84. Petitioner fails to meet its burden to show by a preponderance of the evidence that claim 2 is unpatentable over Brown and Ho.” slip op. at 35

    • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner

      “description is an objective inquiry into the four corners of the specification from the perspective of a POSA. Using this test, the invention must be described in a manner sufficient to demonstrate that the inventor actually invented the claimed invention. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010). “One shows that one is ‘in possession’ of the invention by describing the invention, with all its claimed limitations, not that which makes it obvious.” Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997). Written description is a question of fact judged as of the relevant filing date. Falko–Gunter Falkner v. Inglis, 448 F.3d 1357, 1363 (Fed. Cir. 2006). An ipsis verbis disclosure, however, is not necessary to satisfy the written description requirement. Vas–Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991). The disclosure need only reasonably convey to a POSA that the inventor had possession of the subject matter in question, even if every nuance of the claims is not explicitly described in the specification. Id.; see Ariad, 598 F.3d at 1351. Patent Owner argues that the ’993 patent claims were “fully supported as of the filing date of at least the ’606 Application . . . March 11, 2004” because the ’606 Application discloses regulating water flow and a POSITA would know that appropriate devices for regulating water flow includes nonadjustable waterflow restrictors. PO Resp. 68; PO Sur-reply 28–30. Patent Owner’s argument is persuasive. The ’606 Application discloses: [W]hen the toilet fill valve 100 is open and water flows from the water inlet 103 to the water outlets 106 and into a toilet tank, an amount of water is also supplied to the bowl fill valve inlet 113 that flows through the bowl fill valve 109 and out the bowl fill valve outlet 116. By virtue of the manual setting of handle 119 valve 109 is regulated. In this manner, the flow of water is regulated so that enough water flows out of the bowl fill valve 109 to fill a toilet bowl without wasting any water down a drain. Ex. 1012, 47, ¶ 8 (emphasis added); see also Ex. 1001, 2:28–39. As can be seen from the passage above, the ’606 Application discloses regulating an amount of water supplied to a toilet bowl using a valve (i.e., a water flow regulator). Ex. 2013 ¶ 288.” slip op. at 48

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

      “1. Analysis of Claims 1–18 Schuster is available as prior art if the ’993 patent is only entitled to its January 27, 2014, filing date and not entitled to claim priority to earlier filing dates of the parent applications. On its face, the ’993 patent claims priority to a number of earlier parent applications, including Application No. 12/786,904 (the ’904 Application) filed May 25, 2010, and the Application code 63. Petitioner contends that the ’993 patent is not entitled to claim priority to the filing date of the earlier parent applications, and, thus, Schuster, a parent application of the ’993 patent, is available as prior art.15 Pet. 91–92. Petitioner alleges that the earlier parent applications, specifically Application No. 12/786,904 (the ’904 Application), do not provide written description support for the ’993 patent’s claim term “water flow regulator.” According to Petitioner, “water flow regulator” encompasses both adjustable devices for restricting the flow of water (i.e., valves) and fixed devices for restricting the flow of water (i.e., restrictors). Pet. 15. Petitioner contends that the ’904 Application does not provide support for water flow restrictors and, thus, does not provide support for the broader claim term water flow regulators. Id. at 14–15, 91–92. Petitioner argues that only adjustable water flow devices (i.e., valves) are supported by the ’904 Application. Id. Petitioner, thus, asserts that earliest effective filing date of the ’993 patent’s claims is the filing date of its application, January 27, 2014. Id. at 92. To be entitled to claim the benefit of an earlier filing date under 35 U.S.C. § 120 each application in the priority chain must comply with the written description requirement of 35 U.S.C. § 112(a). See Hollmer v. 14 The parties do not dispute that the ’993 patent and the earlier parent applications, including the ’904 Application and the ’606 Application, have the same pertinent portions of their specifications. See PO Resp. 71, n.16; Ex. 1004 ¶ 324. 15 Schuster issued on January 31, 2012, from Application No. 12/786,904, filed on May 25, 2010. Ex. 1029, code (21), (22), (45). Schuster, thus, issued more than one year prior to January 27, 2014.” slip op. at 46

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

      “2. Analysis of Claims 19 and 20 Claim 19 depends from claim 14 and additionally recites, “wherein the waterflow regulator comprises an adjustable water flow regulator that is configured to adjust the flow rate of the second portion of the water based at least in part on a setting of the adjustable water flow regulator.” Ex. 1001, 12:16–20. Claim 20 depends from claim 14 and recites the same additional limitation. Id. at 12:21–24. Claims 19 and 20, thus, require the water flow regulator to be an adjustable water flow regulator. Petitioner indicates that the earlier parent applications provide written description support for an adjustable water flow regulator. Pet. 91 (“[T]he ’904 application specification makes it clear that the adjustability of the bowl fill valve is a desirable and essential feature of the invention”); PO Surreply 28. Accordingly, Petitioner fails to meet its burden to show, by a preponderance of the evidence, that claims 19 and 20 are unpatentable over Schuster.” slip op. at 50

    Patent outcomesUS 9,139,993 mixed
    § 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
    Patents in suitUS 9,139,993
  • Axonics, Inc. v. Medtronic, Inc.Some claims unpatentable
    PTAB · Mar 21, 2024 · IPR2020-00679 · APJ Brent M Dougal · IPR · Remand

    On remand, claims 1, 2, 4, 7, 10–12, 14, 22, and 23 were held unpatentable over Young, Gerber, and Lindegren; claims 18–21 and 24 were not shown unpatentable.

    RulingsRemand decision
    • RemandOther

      “First, the Federal Circuit stated that “[o]nly the Board’s findings about the combination of Young and Gerber are presented for review in this appeal.” Axonics, 73 F.4th at 954. Thus, the Federal Circuit does not address our prior determination that Petitioner has not shown, by a preponderance of the evidence, that claims 1, 2, 4, 7, 10–12, 14, and 18–24 are unpatentable over the combination of Gerber, Hauser, and Akerström. See FWD 38–59. Second, the Federal Circuit summarized their holding and provided guidance as follows: First, even if the Board was correct to treat the Medtronic patents at issue as limited in the problem they address to the sacral-nerve context, the Board committed a fundamental legal error in confining the motivation inquiry to whether a motivation would exist to make the proposed combination for use in the Young-specific trigeminal-nerve context—to which the Medtronic patents are not limited. Second, the Board was incorrect in its view that “the relevant art is medical leads specifically for sacral neuromodulation,” J.A. 13, as the Medtronic patents’ claims are not limited to the sacral-nerve context and the shared specification, properly read, is not so limited either. Axonics, 73 F.4th at 957 (emphases added). We now reevaluate our findings and determinations involving the grounds with both Young and Gerber.” slip op. at 4

    • Skill levelSkill level board ownDecided for patent owner

      “neuromodulation.” FWD 15. Consistent with the Federal Circuit decision and our finding of the relevant art, the experience of one of ordinary skill is not limited to “sacral neuromodulation.” Rather, the level of ordinary skill in the art requires experience in the relevant art, which is medical leads. Petitioner argues that one of ordinary skill in the art should not be limited to the art of “implantable medical leads,” but should include the broader area of “active, implantable medical devices.” Pet. PR 4. Petitioner explains that this is because this broader area is “not . . . limited to [the] constraints of specific anatomies,” consistent with the Federal Circuit’s decision. Id. However, this is also true for the relevant art of medical leads. A person of ordinary skill in the art of medical leads will have knowledge of specific anatomies, but knowledge of any one particular anatomy is not required. We see no reason to expand the required experience to areas related to, but outside of, the relevant field. As noted above, Petitioner essentially agrees with what we have found to be the relevant field. Id.; Pet. PR Reply 4. However, Petitioner does not provide any convincing argument explaining why one of ordinary skill in the art should not be required to have skill in the defined art. We also note that Petitioner does not argue that such a finding would impact any aspect of our decision.” slip op. at 10

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

      “No terms require express construction. 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 11

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

      “between the multiple electrodes and the tines. Dec. 35 (“Young discloses multiple active sites near the tip, not at the tip or distal to the tines”). Young is in fact silent on this relationship. Young states that “[t]he electrode could be improved to provide multiple active stimulation sites near the tip. [This could allow treatment of] . . . patients with pain in all three trigeminal divisions.” Ex. 1010, 10. At the same time, Young shows two tine elements separate and distal of the electrode in Figure 1. Further, Petitioner relies on Gerber for teaching multiple electrodes at the distal end and distal to the anchoring mechanism. See Pet. 23–24. We find that Gerber teaches or at least suggests multiple electrodes distal to the anchoring devices. See Ex. 1012, 3:39–48, 4:13–52, 5:33–50, Figs. 1–3, 6. Still further, Mr. Pless’s testimony is uncontroverted that “it had been a common practice to add electrodes at the distal tip of the lead for percutaneous implantations before 2001.” Ex. 1003 ¶ 90. In view of the teachings of Young, Gerber, and the testimony of Mr. Pless, Petitioner has shown that one of skill in the art would have been motivated to add electrodes to the distal end of Young, distal to the tines.” slip op. at 20

    Patent outcomesUS 8,626,314 mixed
    Claim construction§ 103 obviousnesscites KSR
    Patents in suitUS 8,626,314
  • PTAB · Dec 18, 2023 · IPR2022-01086 · APJ Patrick M Boucher · IPR · Final written decision

    Claims 1, 3, 5, 9, 12, 13, and 15 are unpatentable over Sonohara; claims 20 and 21 were not shown unpatentable because Sonohara’s assignment rule is based on timestamps.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Patent Owner’s expert, Dr. Goodrich, proposes what Patent Owner characterizes as “a somewhat different level,” namely “an individual with at least a bachelor’s degree in Computer Science or related area and two years of experience developing software tools and/or computer systems for use in the area of audio or video creation, encoding, and/or distribution.” PO Resp. 13; Ex. 2007 ¶ 50. Although we agree that the respective articulations are “somewhat different,” they are generally similar, and our Decision does not depend on nuanced distinctions regarding the level of ordinary skill. Indeed, Dr. Goodrich describes his proposed articulation as “approximate,” such that “more work experience could compensate for less education or more education could compensate for less work experience.” Ex. 2007 ¶ 50. Because we find Petitioner’s proposal reasonable, consistent with the level of skill reflected by the prior art, and supported by Dr. Freedman’s testimony, we adopt it for this Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art). We nevertheless note that we would reach the same ultimate conclusion that claims 1, 3, 5, 9, 12, 13, and 15 (but not claims 20 and 21) have been shown to be unpatentable by a preponderance of the evidence were we to adopt Patent Owner’s proposal. See PO Resp. 13 (“this Response establishes that Petitioner’s arguments fail even under its preferred definition of the level of ordinary skill”).” slip op. at 12

    • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notNot reached

      “We need not resolve this dispute because we reach the same ultimate conclusion that Petitioner shows, by a preponderance of the evidence, that claims 1, 3, 5, 9, 12, 13, and 15 are unpatentable, but not that claims 20 and 21 are unpatentable, even if we apply Patent Owner’s proposed construction that the preambles are limiting and the first and second data files must be different. See Reply 15 (Petitioner asserting that “there is no need to construe the preambles as the prior art meets them even if construed”); Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). For purposes of this Decision, we accordingly treat the preambles of independent claims 1 and 9 as limiting, and with the recited “first data file” and “second data file” as distinct data files.4” slip op. at 14

    • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for patent owner

      “We agree with Patent Owner’s contention that the emphasized sentence defines the term “content-related.” See PO Resp. 15–16 (Patent Owner arguing that “[t]here are thus three strong indications of lexicography: (1) ‘content-related’ is set off by quotation marks; (2) the patentee used the word ‘is’ to describe the term ‘content-related’; and (3) the patentee states what ‘content-related’ is ‘understood to mean.’” Nor does Petitioner disagree that the sentence is definitional. See Tr. 8:15–16 (referring to the “term content-related as it’s defined in the specification”). Indeed, in the Starz litigation, the district court also treated the sentence as definitional, a fact that we find significant as a matter of comity. See Ex. 1018, 111:24–112:1 (district court judge stating at Markman hearing, “I’m going to adopt . . . the express definition provided in the specification”). But like the district court, we discern insufficient reason to adopt the additional gloss that Patent Owner seeks to apply to the definition of “content-related.” That is, Patent Owner proposes that we additionally construe the phrase “syntactical meaning” within the definitional statement to arrive at Patent Owner’s proposed construction. PO Resp. 16–20. According to Patent Owner, “[t]he specification makes clear, through its use of consistent and repeated examples, that ‘syntactical meaning’ requires a specific relationship between the data segments within a data file: succeeding data segments within a data file must be ordered so as to present the content in its intended sequence when rendered.” Id. at 17 (citing VirnetX Inc. v. Cisco Sys., Inc., 767 F.3d 1308, 1317–19 (Fed. Cir. 2014); Alloc, Inc. v. ITC, 342 F.3d 1361, 1368–71 (Fed. Cir. 2003)). Patent Owner adds that the claims, the context provided by the problems solved by the ’794 patent, and the cross-examination testimony of Petitioner’s expert, Dr. Freedman, all support this additional aspect of Patent Owner’s proposed construction. Id. at 18–20. Relying on additional direct testimony by Dr. Freedman, Petitioner counters this position as “improperly import[ing] limitations from the specification that are not required by the claims” and “render[ing] other portions of claim 1 superfluous.” Reply 3 (citing Ex. 1016 ¶ 22); see Tr. 10:18–20 (Petitioner explaining at oral hearing that “the syntax information is simply just identification information which is used to find out what the order of the files is. But the identification information does not by itself indicate the order. It’s just an identifier.”). We agree with Petitioner that it would be imprudent to adopt Patent Owner’s additional gloss because, “[w]hile claims must be construed in light of the specification, . . . limitations from the specification are not to be read into the claims, . . . for ‘[i]t is the claims that measure the invention.’” Golight, Inc. v. Wal-Mart Stores, Inc., 355 F.3d 1327 (Fed. Cir. 2004) (quoting SRI Int’l v. Matsushita Elec. Corp. of Am., 775 F.2d 1107, 1121 (Fed. Cir. 1985) (other citations omitted). It is apparent that the Applicant for the ’794 patent understood how to define terminology recited in the claims, but chose to limit its definition of “content-related” in terms of the broader phrase “syntactical meaning” rather than through narrower specific reference to presentation order. In addition, claims 1 and 9 already specify “sequentially outputting the first and second data segments according to their chronological sequence,” which supports Petitioner’s observation that requiring an additional sequential order to “content-related . . . data segments” renders other portions of claim 1 superfluous. See Reply 3. We accordingly adopt the definitional construction provided by the” slip op. at 16

    • Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalDisclaimer not foundDecided for petitioner

      “As a basic principle of claim interpretation, prosecution disclaimer promotes the public notice function of the intrinsic evidence and protects the public’s reliance on definitive statements made during prosecution.” Omega Engineering, Inc. v. Raytek Corp., 334 F.3d 1314, 1323 (Fed Cir. 2003) (citing Digital Biometrics, Inc. v. Identix, Inc., 149 F.3d 1335, 1347 (Fed. Cir. 1998)) (emphasis added). As such, a statement during prosecution qualifies as a disavowal of claim scope only if it is “so clear as to show reasonable clarity and deliberateness” and “so unmistakable as to be unambiguous evidence of disclaimer.” Id. at 1325 (citations omitted). “Consequently, for prosecution disclaimer to attach, [Federal Circuit] precedent requires that the alleged disavowing actions or statements made during prosecution be both clear and unmistakable.” Id. at 1325–26. “The party seeking to invoke prosecution history disclaimer bears the burden of proving the existence of a clear and unmistakable disclaimer that would have been evident to one skilled in the art.” Mass. Inst. of Tech. v. Shire Pharms., Inc., 839 F.3d 1111, 1119 (Fed. Cir. 2016). And “[s]tatements by the patent owner are not considered in a vacuum; rather, the skilled artisan would look at the record as a whole in assessing claim scope.” Galderma Lab’s v. Amneal Pharma, 806 F. App’x 1007, 1010 (Fed. Cir. 2022) (citing Wang Labs., Inc. v. Toshiba Corp., 993 F.2d 858, 867 (Fed. Cir. 1993) (“The prosecution history must be examined as a whole in determining whether estoppel applies.”)). We have reviewed the prosecution history, which we summarize supra § I.A.3., and we have particularly reviewed those portions highlighted by Patent Owner. See PO Resp. 32–40. We reach the same conclusion as the district court in the Starz litigation that the standard for attachment of prosecution disclaimer is not met. See Ex. 1018, 109:15–22 (district court stating at Markman hearing, “I’ve also carefully reviewed the portions of the prosecution history relied on by VideoLabs, including the patentee’s arguments regarding the Shin and Rosenau references, and I’m up [sic: not6] persuaded there was a clear and unmistakable disclaimer of all assignment rules that perform assignments by using exact timing information”). slip op. at 20

    Patent outcomesUS 8,605,794 mixed
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 8,605,794
  • PTAB · Nov 28, 2023 · IPR2022-00943 · APJ Sharon Fenick · IPR · Final written decision

    Claims 1–7, 9–13, 15, and 16 are unpatentable as obvious; claims 8 and 14 were not shown unpatentable.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner argues that: On or before 7/12/2017, [one of ordinary skill in the art] would have had a bachelor’s degree in computer science, in electrical engineering, or a related field, and approximately three years of experience or equivalent study in voice-controlled devices in smart home systems. Additional graduate education could 2 Neither party presents arguments or evidence relating to such objective evidence of nonobviousness. in the field could substitute for formal education. Pet. 18. We adopted this definition for the purposes of the Decision on Institution. Dec. on Inst. 8–9. Patent Owner adopts Petitioner’s definition. PO Resp. 4. We again adopt Petitioner’s definition, which is consistent with the level of skill as reflected in the prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 8

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

      “Absent a recitation of order, or an order mandated by grammar or logic, the steps of a method claim are not construed to require a particular order. See, e.g., Altiris, Inc. v. Symantec Corp., 318 F.3d 1363, 1369 (Fed. Cir. 2003). Patent Owner argues that the steps of claim 1, a method claim, must be performed in sequential order. PO Resp. 13–16. Without commenting on or conceding Patent Owner’s proposal, Petitioner contends that “the trial grounds meet this proposed construction.” Pet. Reply 24–25; Tr. 8:25–11:16. Our record does not reflect any indication that Patent Owner’s proposed construction requiring the sequential ordering of the method steps is not at least encompassed by the correct construction of claim 1. Because of this, and because Petitioner agrees that the arguments in the Petition meet this construction, we accept Patent Owner’s construction as correct for the purposes of this Decision.” slip op. at 10

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

      “We do not agree with Patent Owner that Petitioner’s showing uses the same sound data to teach the “first sound data” of limitation 1.a and the “second sound data” of limitation 1.c. Patent Owner is correct that Rosenberg’s claim 5 describes the determination of a volume threshold based on the volume of the ambient audio signal in which characteristic form(s) (e.g., the name of the user of the media player) are present. Ex. 1006, 13:66–21, 14:28–30. However, the Petition describes using Fu’s “predetermined threshold” in combination with Hart-787’s device, which attenuates audio output of a device upon detecting a user’s utterance intended to gain the attention of the device, in order to “include adjusting the audio output volume of a wirelessly-linked audio-producing device when the voice-controlled device determines that the ambient noise level at the time a Ex. 1004, 2:22–37, 5:61–6:10, 9:18–25; Ex. 1005 ¶¶ 24, 32, 54; Ex. 1003 ¶¶ 88–89). Petitioner further proposes including a threshold that is advantageously based on the environment in which the device is operating as described in Fu, for example to respond to differing levels of noise at different times of day. Id. at 26, 29–30, 40 (citing Ex. 1006, 10:42–67, 14:28–30; Ex. 1003 ¶¶ 48–53, 55, 58, 87, 91, 107–109). We agree with Petitioner that Patent Owner’s arguments address the references individually instead of addressing the combination of the teachings proposed in the Petition. See Pet. Reply 8, 13–14; see also Dec. on Inst. 21–22, 23–24, 25–26. The Petition relies upon a combination of elements of Hart-787 with the predetermined threshold as taught in Fu and with establishing such a threshold based on the operating environment of a device as in Rosenberg. Pet. 26–31, 34–41. Patent Owner is correct that Rosenberg’s threshold is set at the time of the utterance in Rosenberg’s claim 5 and cites Petitioner’s declarant as “conceding” issues regarding how “Rosenberg’s volume threshold is determined.” PO Resp. 20–21. But this argument and the ostensible concession do not squarely address the proposed combination, which combines Fu’s teaching of an adjustment unit that “compares the volume of the ambient noise received . . . to a predetermined threshold” with Rosenberg’s teaching that such “a threshold may be ‘determined based on the volume of [an] ambient audio signal.’” Pet. 39, 40 (emphasis omitted) (quoting Ex. 1006, 14:28–30). While Patent Owner argues that “Petitioner has not proposed using a predetermined/pre-set threshold or a previously established threshold based on environmental noise in the combination of Hart-787 with F[u] and Rosenberg” (PO Resp. 46), we find, on the contrary, that the Petition describes a combination based predetermined threshold” and on a threshold “determined according to an environmental noise level.” Pet. 29–30. Thus, we find Petitioner’s unpatentability grounds do not suffer from the issues Patent Owner argues are a consequence of the purported use of the same sound data for the “first sound data” of claim limitation 1.a and for the “second sound data” of claim limitation 1.c. We do not agree with Patent Owner’s arguments regarding Fu’s teachings with respect to limitation 1.e’s “transition from a first state having a first volume level to a second state having a second volume level that is less than the first volume level” because these arguments similarly do not address the proposed combination. See PO Resp. 26–30. The Petition cites Hart-787 for attenuating the volume of an audio-producing device when a wake word is issued. Pet. 32–34, 43–44. The Petition cites Fu for adjusting volume of an audio-producing device if the level of ambient noise exceeds a predetermined threshold. Id. at 36–39, 44–45. Thus, even if Fu teaches only increasing the volume of an audio-producing device if the predetermined threshold is exceeded, the Petition relies on the combination of teachings of Hart-787 and Fu, and Patent Owner’s argument that neither reference teaches “decreasing a controllable appliance’s volume output when a previously established volume threshold is exceeded” (PO Resp. 30) does not address the combination proposed. Patent Owner’s argument that “Petitioner has not proposed modifying Fu to decrease a controllable appliance’s volume output when a volume threshold is exceeded” (PO Resp. 30) similarly does not address the combination proposed in the Petition. We also find that the preponderance of the evidence supports Petitioner’s showing regarding the motivation to combine the references.” slip op. at 23

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

      “We also find that the preponderance of the evidence supports Petitioner’s showing regarding the motivation to combine the references. transmitted volume down control signals as the means for attenuating audio output, Petitioner contends that Hart-787 “broadly teaches” that a device transmits control command signals to the audio-producing device, relying on the testimony of its declarant. See Pet. 23 (citing Ex. 1004, 5:47–51; Ex. 1003 ¶ 82), 43–44 (citing Ex. 1004, 1:67–2:7, 2:26–27, 5:47–51; Ex. 1003 ¶ 118). In addition, Petitioner shows that these control signals were well-known in the art and would have been known to one of ordinary skill in the art at the time of the invention, supporting its showing with additional testimony from its declarant. Id. at 44 (citing Ex. 10183, 2:39–47, 5:35–38; Ex. 10194 ¶¶ 3, 13; Ex. 1003 ¶¶ 44–45, 118). We conclude Petitioner’s evidence regarding the showing in Hart-787 is sufficient with respect to this point. Hart-787 describes altering a signal sent to the speaker to attenuate the audio from that speaker. Ex. 1004, 1:67– 2:1. Petitioner’s declarant testifies that using transmitted control signals to do this would have been known to one of ordinary skill. Ex. 1003 ¶¶ 44–45, 82, 118. We consider Petitioner’s evidence regarding what one of ordinary skill in the art would have understood from Hart-787’s disclosure to be sufficient for the showing regarding the “causing one or more commands to be automatically issued to the controllable appliance to thereby cause” that appliance to transition to a lower volume level, as required in limitation 1.e. While Patent Owner argues that Petitioner’s declarant “concede[s] that Hart- 787 does not disclose or teach how its voice-controlled device decreases the audio output of the controllable appliance,” the cited portion of the” slip op. at 25

    Patent outcomesUS 10,930,276 mixed
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 10,930,276
  • PTAB · Nov 2, 2023 · IPR2022-00914 · APJ James A Tartal · IPR · Final written decision

    Claims 105 and 106 are unpatentable as obvious over Heller and Mastrototaro; Abbott did not prove claims 49, 80, 81, 85, or 86 unpatentable on the asserted grounds.

    RulingsFinal written decision
    • Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableNot shown unpatentableMixed

      “on the general knowledge of a person of ordinary skill in the art to disclose the predictive relationship limitation of claim 49 not taught by Heller are legally deficient. Resp. 28–38. We agree in that Petitioner’s contentions in the Petition amount to no more than a conclusory assertion that a person of ordinary skill in the art “would have known” the predictive relationship limitation. See Pet. 38–39. Petitioner’s arguments in the Petition are divorced from any analysis of Heller and fail to articulate why a person of ordinary skill in the art would have understood Heller to teach the predictive relationship in light of what was purportedly known more generally in the art. Merely asserting that a particular limitation was “known in the art” does not constitute a legally sufficient basis for establishing obviousness. See, e.g., Deere, 383 U.S. at 17–18. While Petitioner purports to identify multiple references that teach a predictive relationship, Petitioner circumvents a legally sufficient obviousness analysis by choosing not to assert any of the references in combination with Heller, but to instead argue they all collectively show that “predictive relationships” were broadly known in the art. See Pet. 28–33. Rather than establish some broad understanding by persons of ordinary skill in the art concerning the predictive relationship limitation, Petitioner’s arguments make clear that each reference uniquely addressed the relationship between a particular sensor and the in vivo performance of the sensor. For example, Petitioner asserts Gross teaches a sensor for which “the pre-insertion, factory-determined in vitro performance curve and” slip op. at 32

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

      “level in Gross is a “measure of sensor current, not ‘analyte concentration’ is contrary to the express disclosure of Gross. Gross expressly discloses a calibration method that requires, after insertion the in vivo measurement of a saturation level G1 “which can be measured by the sensor and which is of importance for the calibration method.” Ex. 1004, 13:3–18 (further stating that a “voltage V1 (FIG. 4C) applied at time t1 gives a current I1, (FIG. 4B) which corresponds to the saturation level G1 (FIG. 4A) of the enzyme”). Gross explains that “the predetermined stimulus is adapted to saturate the sensor such that the first signal is a maximum signal,” and “[w]hen a sensor is such that it can be saturated by a sufficiently large stimulus, it can be preferable to use this phenomenon in calibrating the sensor as it enables a reproducible first predetermined stimulus, i.e. a saturation stimulus to be provided in all cases, thereby removing uncertainty as to whether the means for providing a predetermined stimulus will in fact achieve exactly the right level of uncertainty.” Id. at 3:17–26.” slip op. at 45

    • Obviousness (§103) › Objective indicia / secondary considerationsNot reached

      “of ordinary skill in the art; and (4) when in evidence, objective evidence of nonobviousness. 5 Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). An obviousness analysis “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR, 550 U.S. at 418. However, Petitioner cannot satisfy its burden of proving obviousness by employing “mere conclusory statements.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380 (Fed. Cir. 2016). Instead, Petitioner must articulate a reason why a person of ordinary skill in the art would have combined the prior art references. In re NuVasive, 842 F.3d 1376, 1382 (Fed. Cir. 2016); see also Pers. Web Tech., LLC, v. Apple, Inc., 848 F.3d 987, 993–94 (Fed. Cir. 2017) (“[O]bviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed invention”) (quoting Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015)) (alteration in original).” slip op. at 15

    • ExcludeMotion to exclude, deniedDenied

      “In light of the foregoing multiple critical misrepresentations, Petitioner’s MTE is denied regarding sufficiency of Dr. Baura’s qualifications because Petitioner did not timely object to the evidence on the basis asserted in the MTE, fails to refute Patent Owner’s showing that Dr. Baura is sufficiently qualified (see MTE Opp. 3–7; Ex. 2010 ¶ 30), and abandons its argument in its Reply to the MTE.” slip op. at 57

    Patent outcomesUS 11,000,213 mixed
    § 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,000,213
  • PTAB · Nov 2, 2023 · IPR2022-00913 · APJ James A Tartal · IPR · Final written decision

    Claims 1, 20, and 21 are unpatentable as anticipated by Heller; the evidence does not establish claims 4–6, 8, or 23–26 unpatentable on the asserted grounds.

    RulingsFinal written decision
    • Expert testimonyMotion to exclude, deniedDenied

      “In opposition, Patent Owner first argues, and we agree, that Petitioner failed to timely object to Dr. Laura’s declaration with sufficient particularity. MTE Opp. 1–3 (citing 37 C.F.R. § 42.64(b)(1)). Our Rule requires that an “objection must identify the grounds for the objection with sufficient particularity to allow correction in the form of supplemental evidence.” 37 C.F.R. § 42.64(b)(1)). Petitioner’s objection to Dr. Baura’s testimony identifies hundreds of paragraphs from her declaration followed by an objection stating her “testimony is based on insufficient facts or data, is not the product of reliable principles and methods, and does not reliably apply the appropriate principles and methods to the fact of the case.” Paper 25, 2. Petitioner’s boilerplate objection is woefully insufficient to show that Petitioner objected with sufficiently particularity to allow correction in the form of supplemental information, as our Rule requires. We further agree with Patent Owner that Petitioner’s arguments in the MTE are no more than a “transparent attempt to . . . circumvent the word-count limits of its merits briefing by injecting merits arguments in its evidentiary motion.” MTE Opp. 9. In short, Petitioner’s arguments go to the weight to be afforded Dr. Baura’s testimony, not to its admissibility, and are, therefore, an improper basis for seeking the exclusion of hundreds of paragraphs Dr. Baura’s declaration. Accordingly, Petitioner’s MTE is denied.” slip op. at 63

    • Skill levelSkill level petitioner adoptedOther

      “Patent Owner does not dispute Petitioner’s proposed level of ordinary skill. Resp. 9. Dr. Baura, in support of Patent Owner, states that she applied Petitioner’s “definition of the level of ordinary skill in the art, because,” in her opinion, Petitioner’s “and Dr. Smith’s conclusions are incorrect even under this definition.” Ex. 2010 ¶ 29. Thus, Dr. Baura neither adopts as proper nor refutes Petitioner’s proposed level of ordinary skill. We find that the ’213 patent and the cited prior art references reflect the appropriate level of skill at the time of the claimed invention and that the level of appropriate skill reflected in these references and the ’213 patent is consistent with the definition of a person of ordinary skill in the art proposed by Petitioner. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 17

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

      “In view of the issues we address below, including how the claimed subject matter is alleged to have been taught or disclosed in the prior art, we determine that it is not otherwise necessary to address the express interpretation of any claim term. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017); Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy”).” slip op. at 20

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed

      “We agree with Patent Owner that Petitioner’s anticipation argument is insufficiently supported by Heller or the other evidence Petitioner relies upon. Petitioner directs us to no evidence in Heller expressly addressing a predictive relationship between in vitro and in vivo sensitivity, much less any disclosure in Heller of a particular relationship. Instead, Petitioner seeks to stretch a thin disclosure in Heller that “calibration data may simply be factory-determined calibration measurements” to necessarily mean “prior sensitivity information is derived at least in part from a predictive relationship between an in vitro sensor sensitivity to glucose and an in vivo sensor sensitivity to glucose,” as required by claim 23. Pet. 36; Ex. 1005, 77:14–15. Notably, Dr. Smith does not identify any “predictive relationship” disclosed by Heller. Ex. 1002 ¶¶ 148–149. We give little weight to Dr. Smith’s conclusory assertion that a person of ordinary skill in the art would have simply “recognized” Heller’s “factory determined calibration measurements” were necessarily “derived at least in part from a predictive relationship between an in vitro and an in vivo sensor sensitivity to glucose,” particularly where Heller does not expressly preclude in vitro measurements from its “factory determined calibration measurements.” See id. Further, in reply, Petitioner argues again that “(1) Heller discloses that calibration data can ‘simply be factory determined calibration measurements’ . . . and (2) a [person of ordinary skill in the art] would have recognized that this ‘discloses that factory (in vitro) determined sensitivity adequately predicts in vivo sensitivity.’” Reply 6. From Heller’s disclosure preponderance of the evidence that Heller expressly teaches any predictive relationship, even one in which in vitro and in vivo sensitivity are the same. that calibration data can “simply be factory determined calibration measurements,” Petitioner provides no more than speculation to suggest that there necessarily must be some relationship between in vitro measurements and in vivo measurements. See Reply 6–8. Because Petitioner has not shown by a preponderance of the evidence that Heller discloses all of the limitations of clam 23, we determine Petitioner has not shown that Heller anticipates claim 23.” slip op. at 31

    Patent outcomesUS 11,000,213 mixed
    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,000,213
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