Case 8:19-cv-02115-DOC-JDE Document 139 Filed 07/15/22 Page 1 of 29 Page ID #:8075
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`Nimalka Wickramasekera (SBN: 268518)
`NWickramasekera@winston.com
`Joe S. Netikosol (SBN: 302026)
`JNetikosol@winston.com
`WINSTON & STRAWN LLP
`333 S. Grand Avenue
`Los Angeles, CA 90071-1543
`Telephone: (213) 615-1700
`Facsimile:
`(213) 615-1750
`
`George C. Lombardi (pro hac vice)
`GLombard@winston.com
`J.R. McNair (pro hac vice)
`JMcNair@winston.com
`Vivek V. Krishnan (pro hac vice)
`VKrishnan@winston.com
`WINSTON & STRAWN LLP
`35 W. Wacker Drive
`Chicago, IL 60601-9703
`Telephone: (312) 558-5600
`Facsimile:
`(312) 558-5700
`
`Attorneys for Plaintiffs
`MEDTRONIC, INC.; MEDTRONIC PUERTO RICO OPERATIONS CO.;
`MEDTRONIC LOGISTICS, LLC; MEDTRONIC USA, INC.
`
`
`
`UNITED STATES DISTRICT COURT
`CENTRAL DISTRICT OF CALIFORNIA
`
`Case No. 8:19-cv-02115-DOC-JDE
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`PLAINTIFFS’ RESPONSIVE CLAIM
`CONSTRUCTION BRIEF
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`MEDTRONIC, INC.; MEDTRONIC
`PUERTO RICO OPERATIONS
`CO.; MEDTRONIC LOGISTICS,
`LLC; MEDTRONIC USA, INC.,
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`Plaintiffs,
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`v.
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`AXONICS, INC.,
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`Defendant.
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`PLAINTIFFS’ RESPONSIVE CLAIM CONSTRUCTION BRIEF
`CASE NO. 8:19-CV-02115-DOC-JDE
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`Axonics Exhibit 1027
`Axonics, Inc. v. Medtronic, Inc.
`IPR2020-00712
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`Page 1 of 29
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`Case 8:19-cv-02115-DOC-JDE Document 139 Filed 07/15/22 Page 2 of 29 Page ID #:8076
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`TABLE OF CONTENTS
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`3.
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`Page
`I.
`INTRODUCTION ................................................................................................ 1
`II.
`LEVEL OF ORDINARY SKILL IN THE ART .................................................. 1
`III. ARGUMENT........................................................................................................ 2
`A.
`“Plurality of Tine Elements” ...................................................................... 2
`B.
`“Indicative of” ............................................................................................ 7
`1.
`“Indicative of” has a clear meaning in the intrinsic record ....... 8
`2.
`“Indicative of” does not mean “accurately measuring (to within
`a 0.1º C margin)” ...................................................................... 10
`The “relevant temperature” is not the output of the temperature
`sensor ........................................................................................ 13
`“adjustable assembly adapted to adjust efficiency of energy
`transfer between the primary coil and the secondary coil” ...................... 13
`“Programmable Limit” ............................................................................. 14
`“Associated With” .................................................................................... 20
`1.
`“Associated with” does not mean “proportional to” ................ 20
`2.
`“Associated with” is not indefinite .......................................... 21
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`F.
`“Current … declines as said voltage … increases” ................................. 23
`IV. CONCLUSION .................................................................................................. 25
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`C.
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`D.
`E.
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`TABLE OF AUTHORITIES
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` Page(s)
`
`Cases
`3M Innovative Props. Co. v. Avery Dennison Corp.,
`350 F.3d 1365 (Fed. Cir. 2003) ............................................................................... 11
`AquaTex Indus., Inc. v. Techniche Solutions,
`419 F.3d 1374 (Fed. Cir. 2005) ............................................................................... 16
`Avid Technology, Inc. v. Harmonic, Inc.,
`812 F.3d 1040 (Fed. Cir. 2016) ............................................................................... 18
`BASF Corp. v. Johnson Matthey Inc.,
`875 F.3d 1360 (Fed. Cir. 2017) ............................................................................... 21
`Bell & Howell Document Mgmt. Prod. Co. v. Altek Sys.,
`132 F.3d 701 (Fed. Cir. 1997) ................................................................................... 7
`DeMarini Sports, Inc. v. Worth, Inc.,
`239 F.3d 1314 (Fed. Cir. 2001) ................................................................................. 6
`Enovsys LLC v. AT&T Mobility LLC,
`2014 WL 12513608 (C.D. Cal. Aug. 22, 2014) ........................................................ 6
`
`Every Penny Counts, Inc. v. Am. Express Co.,
`563 F.3d 1378 (Fed. Cir. 2009) ................................................................................. 2
`Gen. Am. Transp. Corp. v. Cryo-Trans, Inc.,
`93 F.3d 766 (Fed. Cir. 1996) ..................................................................................... 3
`Genuine Enabling Tech. LLC v. Nintendo Co.,
`29 F.4th 1365 (Fed. Cir. 2022) ................................................................................ 17
`Grober v. Mako Products, Inc.,
`686 F.3d 1335 (Fed. Cir. 2012) ............................................................................... 16
`Intel Corp. v. Qualcomm Inc.,
`21 F.4th 801 (Fed. Cir. 2021) .................................................................................... 3
`Intellectual Ventures II LLC v. Commerce Bancshares, Inc.,
`682 F. App’x 891 (Fed. Cir. 2017) ............................................................................ 4
`
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`Jazz Pharm., Inc. v. Amneal Pharm., LLC,
`895 F.3d 1347 (Fed. Cir. 2018) ................................................................................. 4
`Markman v. Westview Instruments, Inc.,
`52 F.3d 967 (Fed. Cir. 1995) ..................................................................................... 7
`Oatey Co. v. IPS Corp.,
`514 F.3d 1271 (Fed. Cir. 2008) ................................................................................. 4
`Packet Intel. LLC v. NetScout Sys., Inc.,
`965 F.3d 1299 (Fed. Cir. 2020) ............................................................................... 22
`Phillips Petroleum Co. v. Huntsman Polymers Corp.,
`157 F.3d 866 (Fed. Cir. 1998) ................................................................................. 19
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) ........................................................................... 3, 21
`Seachange Int’l, Inc. v. C-COR, Inc.,
`413 F.3d 1361 (Fed. Cir. 2005) ................................................................................. 5
`SRI Int’l v. Matsushita Elec. Corp. of Am.,
`775 F.2d 1107 (Fed. Cir. 1985) (en banc) ................................................................. 2
`Trivascular, Inc. v. Samuels,
`812 F.3d 1056 (Fed. Cir. 2016) ................................................................................. 5
`Vita-Mix Corp. v. Basic Holding, Inc.,
`581 F.3d 1317 (Fed. Cir. 2009) ................................................................................. 2
`Vitronics Corp. v. Conceptronic, Inc.,
`90 F.3d 1576 (Fed. Cir. 1996) ............................................................................... 2, 7
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`I.
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`INTRODUCTION
`Axonics’ proposed constructions disregard the intrinsic record—the most
`significant source of a disputed term’s meaning. Instead, Axonics mischaracterizes the
`prosecution histories and relies on inapposite extrinsic evidence, and even the accused
`products, to improperly narrow the claims to avoid infringement. Axonics’ legally and
`factually unsupported, litigation-driven constructions should be rejected. Medtronic’s
`proposed constructions, on the other hand, stay true to the plain and ordinary meaning
`of the claims by looking first to the words of the claims themselves and specifications,
`which are dispositive of the disputed terms’ meanings here.
`II. LEVEL OF ORDINARY SKILL IN THE ART
`The level of ordinary skill in the art for the ’756 and ’314 patents (the tined lead
`patents), as determined by the Patent, Trial & Appeal Board (“PTAB”) in IPR2020-
`00715 and IPR2020-00679, is “(1) a bachelor’s degree, or coursework equivalent, in
`biomedical engineering, electrical engineering, or mechanical engineering, or a medical
`degree, and (2) at least two years of experience researching and developing medical
`leads for sacral neuromodulation.” Ex. A, IPR2020-00715 FWD at 16; Ex. AA,
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`IPR2020-00679 FWD at 15. That is because the “art is sophisticated and requires
`knowledge of human anatomy of the sacral area and the surgical procedures involved
`in sacral neuromodulation.” Id. Medtronic agrees. Axonics ignores this level of
`ordinary skill and instead applies a level of skill expressly rejected by the PTAB.
`The level of ordinary skill for the ’324 and ’112 patents (the temperature sensitive
`recharge patents), as determined by the PTAB in IPR2020-00713 of the ’112 patent,
`which is a continuation of the ’324 patent and shares a common specification and
`priority date, is: “a bachelor’s degree in electrical or mechanical engineering and at least
`three years of experience in the industry working with rechargeable medical
`implantable devices; or a bachelor’s of science with at least six years of experience
`designing, manufacturing, or overseeing rechargeable medical implantable systems.”
`Ex. BB, IPR2020-00713 FWD at 11–12.
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`Claim Terms
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`“plurality of tine elements”
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`’756 patent claim 14
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`Axonics’ Proposed
`Construction
`Two or more structures
`to which one or more
`tines are attached
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`The level of ordinary skill for the ’148, ’758, and ’069 patents (the charge control
`patents), the PTAB found, is: “at least a bachelor’s degree in electrical engineering or
`an equivalent as well as at least five years of experience in the industry working with
`implantable medical devices such as cardiac pacemakers or defibrillators.” Ex. CC,
`IPR2020-00712 FWD at 15–16.
`III. ARGUMENT
`A.
`“Plurality of Tine Elements”
`Medtronic’s Proposed
`Construction
`Two or more parts or
`portions that include tines
`along the length of the
`lead body and which may
`’314 patent claims 1, 11, 18
`form a single structure
`Axonics urges the Court to “dispose[] of the infringement issue” and construe the
`claims in view of Axonics’ accused product, incorrectly characterizing it as having “a
`Single ‘tine element.’” (Axonics Br. 3.) This is improper. “[C]laims are not construed
`‘to cover’ or ‘not to cover’ the accused device.” SRI Int’l v. Matsushita Elec. Corp. of
`Am., 775 F.2d 1107, 1118 (Fed. Cir. 1985) (en banc). In fact, “[c]laims are properly
`construed without the objective of capturing or excluding the accused device.” Vita-
`Mix Corp. v. Basic Holding, Inc., 581 F.3d 1317, 1324 (Fed. Cir. 2009). And, contrary
`to Axonics’ invitation, “[a] court may not use the accused products for the sole purpose
`of arriving at a construction of the claim terms that would make it impossible for the
`plaintiff to prove infringement.” Every Penny Counts, Inc. v. Am. Express Co., 563 F.3d
`1378, 1383 (Fed. Cir. 2009). Instead, the Court must begin first with “the words of the
`claims themselves” and then, “second, it is always necessary to review the
`specification.” Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir.
`1996). The claim language and specification are dispositive here, and the file history is
`entirely consistent.
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`First, every independent claim of both the ’756 and ’314 patents requires a
`“plurality of tine elements,”1 but only one, unasserted independent claim 1 of the ’756
`patent, requires that the “plurality of [] tine elements” must be “separate from . . . each
`other.”2 ’756 patent cl. 1 at 13:55, 13:67–14:2. All remaining independent claims of
`both tined lead patents critically omit any such requirement that the “plurality of tine
`elements” also be “separate from . . . each other,” as required in unasserted claim 1.
`’756 patent cl. 1 & 14; ’314 patent cl. 1, 11, 18; Phillips v. AWH Corp., 415 F.3d 1303,
`1314 (Fed. Cir. 2005) (“Other claims of the patent in question, both asserted and
`unasserted, can also be valuable sources of enlightenment … [b]ecause claim terms are
`normally used consistently throughout the patent.”). This critical omission supports the
`conclusion that “a plurality of tine elements” alone cannot be solely limited to separate
`structures. Indeed, there is no way to reconcile Axonics’ construction requiring
`“separate” structures because the explicit differences in patentees’ drafted claims show
`that the patentees clearly knew how to—and in fact did—claim “separate” structures in
`one unasserted independent claim, but not in any asserted independent claim. If, as
`Axonics contends, a “‘plurality’ of such tine elements” must already “refer[] to
`multiple, separate tine elements” (Axonics Br. 8), then the further requirement in
`unasserted claim 1 of the ’756 patent that they be “separate from” “each other” would
`be superfluous. Intel Corp. v. Qualcomm Inc., 21 F.4th 801, 810 (Fed. Cir. 2021) (“It is
`highly disfavored to construe terms in a way that renders them void, meaningless, or
`superfluous.”); Gen. Am. Transp. Corp. v. Cryo-Trans, Inc., 93 F.3d 766, 770 (Fed. Cir.
`1996) (rejecting claim construction that was “inconsistent with the specification and
`drawings and rendered superfluous the claim requirement”). Axonics’ proposal directly
`contradicts the claim language and improperly imports the “separate” requirement from
`
`
`1 Unasserted claim 1 of the ’756 patent requires, “a plurality of M tine elements.” All
`remaining independent claims of both the ’756 and ’314 patents require “a plurality of
`tine elements.” ’756 patent cl. 1 & 14; ’314 patent cl. 1, 11, 18.
`2 Unless otherwise noted, all emphasis is added and citations and quotations omitted.
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`unasserted claim 1 of the ’756 patent into all other independent claims.
`Second, even Axonics concedes that the specification expressly states that “it is
`‘within the scope of the present invention to form the tine elements 125, 130, 135 and
`140 or 125′, 130′, 135′ and 140′ and 225, 230, 235, and 240 as a single structure with
`a common tine mounting band extending the length of the tine element array 120.’”
`(Axonics Br. 9.) Unable to dispute these express disclosures that the “plurality of tine
`elements” may, in fact, form a single structure, and need not be physically separate from
`each other, Axonics tries to dismiss them as “passing mentions” that “are merely
`unclaimed embodiments not recited in any claim.” (Axonics Br. 5.) Axonics is wrong,
`and the Federal Circuit has consistently rejected similar arguments dismissing
`disclosures in the specification as mere “unclaimed embodiments.” See, e.g.,
`Intellectual Ventures II LLC v. Commerce Bancshares, Inc., 682 F. App’x 891, 894
`(Fed. Cir. 2017) (rejecting “unclaimed embodiment” argument because “there is no
`basis for treating the specification passage as unclaimed except Intellectual Ventures’
`prior conclusion that the ordinary meaning of the claim language simply cannot include
`the described arrangement”); Jazz Pharm., Inc. v. Amneal Pharm., LLC, 895 F.3d 1347,
`1361 (Fed. Cir. 2018) (rejecting argument because “Jazz provides no persuasive support
`in either the plain meaning of ‘periodic’ or in the written description to exclude an
`embodiment repeatedly highlighted in the specification”). There is no basis to dismiss
`the embodiment of a “plurality of tine elements” formed as a “single structure” as
`unclaimed except for Axonics’ desired but unsupported conclusion that term must mean
`two or more structures. Oatey Co. v. IPS Corp., 514 F.3d 1271, 1276 (Fed. Cir. 2008)
`(courts “normally do not interpret claim terms in a way that excludes embodiments
`disclosed in the specification” unless “those embodiments are clearly disclaimed in the
`specification”).
`For the same reasons, Axonics’ reliance on “‘tine elements’ in the plural form”
`to argue otherwise is entirely misplaced. (Axonics Br. 5–6.) The specification
`expressly states that “the tine elements”—plural—can be formed “as a single
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`structure.” ’314 patent, 13:4–11; ’756 patent, 12:54–57. Axonics’ litigation-driven and
`unsupported position improperly conflates “element” with “structure” and is in conflict
`with the intrinsic evidence.
`Desperate to avoid the claim language and specification, Axonics grossly
`misstates the record to argue prosecution history disclaimer. (Axonics Br. 6–8.) “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.” Trivascular, Inc. v. Samuels, 812 F.3d 1056, 1063–64 (Fed. Cir.
`2016); Seachange Int’l, Inc. v. C-COR, Inc., 413 F.3d 1361, 1373 (Fed. Cir. 2005) (“A
`disclaimer must be clear and unambiguous.”). But there was no disclaimer of any
`kind—much less one that is “clear and unmistakable”—during the prosecution of a
`separate application that Axonics refers to, U.S. Application No. 11/589,407,3 regarding
`a “plurality of tine elements.”
`Instead, the ’407 application initially sought claims that identified “a tine
`element” (claims 1, 14, and 20) and a dependent claim that further comprised “a
`plurality of tine elements” (claim 9). (Axonics Ex. 20 at MDT-00136385–89.) But the
`applicant never distinguished these terms from each other on the basis of whether they
`form a single structure. Id. And contrary to Axonics’ assertion, the applicant never
`amended the claims to recite “a plurality of tine elements” to overcome any rejection.
`Instead, the prosecution of these claims centered around markers, a fluoroscopy tool
`that allows physicians to understand when the tines are about to deploy, separate
`limitations that significantly distinguish the claim scope from that of the ’314 and ’756
`patents. (Id. at MDT-00136385–89; see also Chai Decl. ¶ 26.) Accordingly, these
`claims were amended to distinguish the prior art, Ollivier, on the location of marker
`positions in relation to the tine elements, which has nothing at all to do with the structure
`of the tine elements themselves. (Axonics Ex. 20 at MDT-00136296, MDT-00136298.)
`
`
`3 Axonics incorrectly calls the ’407 a “parent” to the ’756 patent. (Axonics Br. 6.)
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`Specifically, to distinguish the prior art, “[i]ndependent claims 1 and 14 [were] amended
`to include the subject matter of claims 3 and 18, respectively,” pertaining to relative
`marker positions, and distinguished Ollivier on the basis of those claim limitations, not
`tine elements. (Id. at MDT-00136302–03; see also Chai Decl. ¶ 27.) In fact, Axonics
`concedes that the examiner stated that “Ollivier discloses tine elements, 26”—plural.
`(Axonics Br. 6–7 (quoting Ex. 20 at MDT-0136321–23).) If Ollivier disclosed tine
`elements, plural, the applicant could not distinguish it by claiming “a plurality of tine
`elements” and supposedly disclaim a single tine structure. That is just illogical.
`Nor, as Axonics suggests, did the applicant distinguish the Schroeppel prior art
`on the basis that it has a single structure. Rather, the applicant noted that Schroeppel
`discloses “a single tine element with tines that share a longitudinal position along the
`length of the lead body.” (Axonics Br. 8.) This distinction is consistent with the ’314
`patent specification’s repeated descriptions of the tine elements as being “along the
`length of the lead body,” as opposed to being located all in one place. ’314 patent, 7:1–
`5; 10:59–64; 13:5–11. The prosecution history that Axonics cites never discusses a
`single versus two or more structures. DeMarini Sports, Inc. v. Worth, Inc., 239 F.3d
`1314, 1326 (Fed. Cir. 2001) (refusing to rely on applicant’s lack of argument during
`prosecution to construe claim); Enovsys LLC v. AT&T Mobility LLC, 2014 WL
`12513608, at *13 (C.D. Cal. Aug. 22, 2014) (“The court may not use unclear
`prosecution history to limit claims.”). Simply put, neither the Applicant nor the Patent
`Office ever characterized “plurality of tine elements” as multiple structures, nor was
`any prior art distinguished on that basis.
`Unable to support its claim interpretation with intrinsic evidence, Axonics next
`resorts to extrinsic expert testimony. Axonics’ declaration from Dr. Irazoqui regarding
`“how a POSITA would understand certain statements made by the applicants during
`prosecution,” however, should be given no weight. (Irazoqui Decl. ¶ 50.) Claim
`construction is an analysis based on legal principles and is within the province of the
`Special Master, not an expert. Markman v. Westview Instruments, Inc., 52 F.3d 967,
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`983 (Fed. Cir. 1995) (“This testimony about construction, however, amounts to no more
`than legal opinion—it is precisely the process of construction that the court must
`undertake.”); Bell & Howell Document Mgmt. Prod. Co. v. Altek Sys., 132 F.3d 701,
`706 (Fed. Cir. 1997) (“Patents should be interpreted on the basis of their intrinsic record,
`not on the testimony of such after-the-fact ‘experts’ that played no part in the creation
`and prosecution of the patent.”). Even if Dr. Irazoqui’s “opinions” on the prosecution
`history include expert analysis, Axonics does not explain how he is qualified to testify
`about the understanding of a POSITA when the PTAB found that experience in sacral
`neuromodulation was necessary. (See, e.g., Ex. A, IPR2020-00715 FWD at 16; Chai
`Decl. ¶¶ 22, 23.) He also provides “opinions” regarding the file history in a vacuum,
`without any regard or analysis of the claims or specifications, (Irazoqui Decl. ¶¶ 50–60;
`Chai Decl. ¶ 23), which take precedence. See Vitronics, 90 F.3d at 1582.
`Axonics fails to provide any intrinsic, or extrinsic, evidence that supports its
`proposed construction of “a plurality of tine elements,” which should be rejected.
`B.
`“Indicative of”
`
`Medtronic’s
`Proposed
`Construction
`Plain and ordinary
`meaning, which
`is
`synonymous
`with
`“serving as a sign of”
`
`Axonics’
`Proposed
`Construction
`“accurately
`measuring” the
`relevant
`temperature
`
`Claim Terms
`
`“indicative of” in the context of the
`following claim terms:
`
`“a temperature sensor adapted to provide an
`output indicative of a temperature of the
`side of the housing” (’324 patent claims 1
`and 20)
`
`
`
`“providing, via a temperature sensor of the
`external device, output indicative of a
`temperature of the side of the housing.”
`(’324 patent claim 12)
`
`Axonics’ proposal rewrites the claims as follows: a temperature sensor that
`provides an “output indicative of accurately measuring (to within a 0.1º C margin) a
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`temperature of the side of the housing the relevant temperature.” (See, e.g., Irazoqui
`Decl. ¶ 67 (“a POSITA would have understood ‘indicative’ to refer generally to a
`temperature reading accurate to better than 1º C at the very least … It is the most
`stringent requirement (i.e., 0.1º C resolution) that drives the specification”); Axonics
`Br. 11 (relying on “an exemplary dual-range temperature sensor”).) Axonics’ proposal
`should be rejected for at least three critical reasons: (1) “indicative of” has a clear
`meaning that broadly permits placing the claimed temperature sensor in different
`locations on the external charging device, including not directly on the side of the
`housing, while still providing an output that is indicative of the temperature of the side
`of the housing; (2) “indicative of” does not mean “accurately measuring (to within a
`0.1º C margin)” under any reasonable reading of the term; and (3) the “relevant
`temperature” in Axonics’ proposal does not refer to the output of a temperature sensor.
`“Indicative of” has a clear meaning in the intrinsic record
`1.
`In the context of the claims and specification, a temperature sensor that provides
`
`an “output indicative of a temperature of the side of the housing” means that the claimed
`temperature sensor can be positioned at various locations on the charging device while
`still providing an output that is indicative of the temperature of the side of the housing
`of the charging device. In other words, the claimed temperature sensor need not be
`placed on the side of the housing to provide an output that is indicative of the
`temperature of the side of the housing. (Berger Decl. ¶¶ 22–23.) Indeed, a POSITA at
`the time of the invention reading the specification would have recognized that there are
`practical reasons why it would be valuable to place a temperature sensor in locations
`different from a location of interest such that the output of the temperature sensor serves
`as an acceptable proxy for the temperature of the location of interest. (Id. ¶¶ 23–24.)
`Consistent with this, the specification explains that a temperature “sensor may be
`used to measure a parameter that correlates to a temperature of the system during
`recharge. For example, the measured parameter may be the temperature of a surface
`of an antenna of the external power source during recharge.” ’324 patent, 5:51–54. The
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`specification, thus, discloses that the claimed temperature sensor need not directly
`measure the temperature of the side of the housing, but rather, for example, a surface of
`the antenna that correlates to the temperature of the side of the housing. (Berger Decl.
`¶ 25.) Similarly, the claimed temperature sensor is only required to provide an output
`that is indicative of the temperature of the side of the housing.
`The specification expressly discloses placing sensors in different locations on the
`charging device, as illustrated in Annotated Figure 3 below:
`
`
`
`
`In one exemplary embodiment, the temperature sensor is “located in proximity
`to the AC coil.” ’324 patent, 6:47–48. As illustrated in Figure 3, because this primary
`coil of the charger may not be positioned at the side of housing of the charger, “[i]n a
`specific embodiment, an antenna may house the AC coil and the sensor may be
`thermally-coupled to a surface of the antenna to provide an indication of a temperature
`of the surface of the antenna.” ’324 patent, 6:52–55. Thus, even if the sensor is not
`directly connected to the side of the external charger, it is able to provide an output
`indicative of the temperature of the side of the housing. (Berger Decl. ¶¶ 26–29.)
`In another example illustrated above, the specification describes that the
`temperature sensor “can be positioned in close proximity to the thermally conductive
`material [] in order to obtain reasonably accurate information on the temperature of the
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`external surface of external antenna [] contacting patient.” ’324 patent, 20:11–15. In
`yet a third example illustrated above, the specification describes that “[p]referably, [the]
`temperature sensor [] is affixed to thermally conductive material [] with a thermally
`conductive adhesive.” Id., 20:15–17. In these different locations on the charging
`device, the temperature sensor provides an “output indicative of a temperature of the
`side of the housing” of the external charging device. (Berger Decl. ¶¶ 29–30.)
`“Indicative of” does not mean “accurately measuring (to
`2.
`within a 0.1º C margin)”
`Axonics equates “indicative of” with “accurately measuring (to within a 0.1º C
`margin).” This is plainly an unjustified, wholesale rewrite of the claims. Nothing in
`this term mandates that the claimed temperature sensor provide an output that is the
`temperature of the side of the housing, nor does it require an output that very closely
`tracks (to within a 0.1º C margin) the temperature of the side of the housing. (Berger
`Decl. ¶¶ 31–32.) Axonics’ argument is based the flawed premise that if “indicative of”
`does not mean the exact temperature of the side of the housing or a very “accurate”
`measure of it, “the alleged invention would fail at its stated goal of using the claimed
`temperature sensor to ensure that the sensed temperature does not exceed acceptable
`temperatures.” (Axonics Br. 9.) Axonics falsely and without support asserts that the
`only way to ensure that the temperature of the side of the housing does not exceed a
`certain temperature is for the temperature sensor output to either be the temperature of
`the side of the housing or be a very accurate measure (to within a 0.1º C margin) of it.
`First, there is no logical basis for Axonics’ position. For example, if the output
`of the temperature sensor has a 5º C error margin, the claimed invention would still
`control the transfer of energy to the implantable device based on this output to limit a
`temperature to which a patient is exposed. (Berger Decl. ¶ 33.) If, in this example, the
`temperature limit (of the side of the housing) targeted by the system was 38º C, the
`cont