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`Matthew D. Powers (Bar No. 104795)
`matthew.powers@tensegritylawgroup.com
`William P. Nelson (Bar No. 196091)
`william.nelson@tensegritylawgroup.com
`Natasha M. Saputo (Bar No. 291151)
`natasha.saputo@tensegritylawgroup.com
`TENSEGRITY LAW GROUP, LLP
`555 Twin Dolphin Drive, Suite 650
`Redwood Shores, CA 94065
`Telephone: (650) 802-6000
`Facsimile:
`(650) 802-6001
`
`Azra Hadzimehmedovic (Bar No. 239088)
`azra@tensegritylawgroup.com
`Aaron M. Nathan (Bar No. 251316)
`aaron.nathan@tensegritylawgroup.com
`Samantha A. Jameson (Bar No. 296411)
`samantha.jameson@tensegritylawgroup.com
`Stephen K. Shahida (admitted Pro Hac Vice)
`stephen.shahida@tensegritylawgroup.com
`Alton L. Hare (admitted Pro Hac Vice)
`alton.hare@tensegritylawgroup.com
`TENSEGRITY LAW GROUP, LLP
`8260 Greensboro Drive, Suite 260,
`McLean, VA 22102
`Telephone: (703) 940-5031
`Facsimile:
`(650) 802-6001
`
`Attorneys for Defendant AXONICS, INC.
`
`
`UNITED STATES DISTRICT COURT
`CENTRAL DISTRICT OF CALIFORNIA
`SOUTHERN DIVISION
`
`
`MEDTRONIC, INC.; MEDTRONIC
`PUERTO RICO OPERATIONS CO.;
`MEDTRONIC LOGISTICS, LLC;
`MEDTRONIC USA, INC.,
`
`
`Plaintiff,
`
` Case No. 8:19-cv-02115-DOC-JDE
`
`AXONICS, INC.’S OBJECTIONS
`TO THE TECHNICAL SPECIAL
`MASTER REPORT AND
`RECOMMENDATION ON
`CLAIM CONSTRUCTION (DKT.
`NO. 163-1)
`
`Judge: Hon. David O. Carter
`Special Master: David Keyzer
`
`
`AXONICS MODULATION
`TECHNOLOGIES, INC.,
`
`
`v.
`
`Defendant.
`
`
`
`
`
`OBJS. TO CLAIM CONSTR. R&R.
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`Case No. 8:19-cv-02115-DOC-JDE
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`Axonics Exhibit 1025
`Axonics, Inc. v. Medtronic, Inc.
`IPR2020-00712
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`TABLE OF CONTENTS
`
`Axonics’ Objections To Certain Claim Constructions In Special Master’s
`
`
`
`I.
`II.
`
`INTRODUCTION .......................................................................................... 1
`Report And Recommendation ........................................................................ 2
`A.
`“plurality of tine elements” (756 and 314 Patents) .............................. 2
`B.
`“indicative of” (324 Patent Claims 1, 12, 20) .................................... 14
`C.
`“programmable limit” (112 Patent Claims 1, [8], 22) ....................... 17
`D.
`“value associated with said current” (148 and 758 Patents) .............. 19
`III. CONCLUSION ............................................................................................ 25
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`Cases
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`TABLE OF AUTHORITIES
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`Amgen Inc. v. Coherus BioSciences, Inc.,
` 931 F.3d 1154 (Fed. Cir. 2019) ............................................................................ 7, 11
`Cohesive Techs., Inc. v. Waters Corp.,
`543 F.3d 1351 (Fed. Cir. 2008) ................................................................................. 22
`e.Digital Corp v. Futurewei Techs., Inc.,
`772 F.3d 723 (Fed. Cir. 2014) ................................................................................... 22
`Genuine Enabling Tech. LLC v. Nintendo Co.,
`29 F.4th 1365 (Fed. Cir. 2022) .................................................................................... 9
`Gracenote, Inc. v. Musicmatch, Inc.,
` No. C 02-3162 CW, 2004 WL 5645196 (N.D. Cal. Feb. 2, 2004) ........................... 22
`ICU Med., Inc. v. Alaris Med. Sys.,
`558 F.3d 1368 (Fed. Cir. 2009) ................................................................................. 15
`Interval Licensing LLC v. AOL, Inc.,
` 766 F.3d 1364 (Fed. Cir. 2014) ............................................................................... 23
`O2 Micro Int’l Ltd. v. Beyond Innovation Tech. Co.,
`521 F.3d 1351 (Fed. Cir. 2008) ................................................................................. 25
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) ........................................................................... 13, 16
`Praxair, Inc. v. ATMI, Inc.,
`543 F.3d 1306 (Fed. Cir. 2008) ................................................................................. 15
`Southwall Techs., Inc. v. Cardinal IG Co.,
`54 F.3d 1570 (Fed. Cir. 1995) ................................................................................... 11
`Wilson Sporting Goods Co. v. Hillerich & Bradsby Co.,
`442 F.3d 1322 (Fed. Cir. 2006) ................................................................................. 24
`
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`OBJS. TO CLAIM CONSTR. R&R
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`I.
`
`INTRODUCTION
`While the Special Master’s Report and Recommendation (“R&R”; Dkt. No.
`163-1) properly adopts some of Axonics’ proposed constructions, it commits legal
`error when rejecting others. For example, the R&R’s erroneous construction of
`“plurality of tine elements” to include a single structure—i.e., not a plurality—within
`its scope permits Medtronic to contend that it covers structures it clearly and
`unmistakably told the Patent Office were not a “plurality of tine elements” — a result
`neither the R&R nor Medtronic can explain. And the R&R’s erroneous construction of
`“indicative of” merely substitutes a word (“sign”) that has no meaning in this context,
`is not in the intrinsic record, and is contrary to the purposes of the claimed invention.
`Accordingly, adoption of the R&R’s erroneous constructions would not only invite
`reversal on appeal, but also fail to inform the jury regarding the scope of important
`claim terms and make the case more difficult to try.
`Axonics respectfully refers the Court to, and incorporates here the arguments set
`forth in: the claim construction briefing submitted to the Special Master and filed with
`the Court (Axonics’ Opening Claim Construction Brief (Dkt. No. 111), Axonics’
`Responsive Claim Construction Brief (Dkt. No. 138)); and the arguments and
`demonstrative materials presented at the September 12, 2022, Hearing (Ex. 49
`(9/12/22 Transcript)); Exs. 40 - 45 (Axonics’ demonstrative slides), including inventor
`testimony that was obtained after the claim construction briefing was completed.
`Axonics respectfully objects to the R&R as to the following terms: “plurality of
`tine elements”; “indicative of”; and “value associated with said current.” The Court
`should adopt Axonics’ proposed constructions for these terms as set forth in the claim
`construction briefing, and below. For the term “programmable limit,” to the extent the
`Court adopts the R&R’s reasoning that “‘programmable limit’ requires that the
`relevant limit must be programmable after the apparatus is shipped to distributors or
`customers for use,” and adopts the Special Master’s statement at the Claim
`Construction hearing that no argument contrary to that reasoning should be permitted,
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`then Axonics does not object to the R&R’s construction, although it proposes below a
`modification that makes this reasoning clear in the construction itself.
`Axonics respectfully submits that the Court should adopt the R&R as to Terms
`C (“adjustable assembly . . .”) and F (“wherein said [predetermined] current . . .
`declines as said voltage . . . increases during a charging cycle”).
`II. AXONICS’ OBJECTIONS TO CERTAIN CLAIM CONSTRUCTIONS IN
`SPECIAL MASTER’S REPORT AND RECOMMENDATION
`A.
`“plurality of tine elements” (756 and 314 Patents)
`Medtronic’s Proposed
`Axonics’ Proposed
`Special Master’s R&R
`Construction
`Construction
`Construction
`Two or more parts or
`Two or more
`two or more parts or portions
`portions that include
`structures to which
`(each of which includes one or
`tines along the length
`one or more tines are
`more tines) that are positioned
`of the lead body and
`attached
`along the length of the lead body
`which may form a
`and that may be formed as a single
`single structure
`structure or as multiple structures
`The term “plurality of tine elements” is recited in every independent claim of the
`314 and 756 Patents, and there is no dispute that a “tine element” is a structure from
`which “tines”—protuberances which project from an implantable lead to fix the lead in
`human tissue—extend. See, e.g., Dkt. No. 111-3, Ex. 1 (314 Patent) at 10:12-18,
`10:25-29 (“Each tine element . . . comprises at least one flexible, pliant, tine”).
`Figure 3 of the shared specification depicts an example of a tine element, with tines
`145, 150, 155, and 160 attached to a mounting band 175, and Figure 2 depicts four tine
`elements (i.e., a “plurality” of them) attached to a medical lead.
`
`
`The parties disputed whether the claimed plurality of tine elements could
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`encompass a single structure, in view of the intrinsic evidence—that is, whether the
`claim limitation expressly requiring two or more distinct things could be met by only
`one, as Medtronic contended. The R&R erroneously sides with Medtronic,
`recommending the term be construed as “two or more parts or portions”—whatever
`“parts or portions” means—“(each of which includes one or more tines) that are
`positioned along the length of the lead body and that may be formed as a single
`structure or as multiple structures.” Axonics objects to the R&R’s construction.
`The surest indication that the R&R’s construction is wrong is that it would
`permit Medtronic to contend the term should encompass prior art tine configurations
`Medtronic unmistakably told the Patent Office were not a “plurality of tine elements,”
`thereby disclaiming them from the scope of the invention. Specifically: during
`prosecution of earlier U.S. App. No. 11/589,407 (the “407 Application”), a patent
`application in the same family, and with the same specification as the 314 and 756
`Patents, Medtronic sought claims that would have encompassed a single structure, by
`reciting “a tine element,” under the conventional meaning of “a” as referring to “one or
`more.” Dkt. No. 111-22, Ex. 20 at MDT-00136385 (10/30/2006 submitted claims at
`20). Dkt. Nos. 111-1, 125 (Irazoqui Decl.) at ¶50. Original Claim 1 is presented below:
`
`1. An implantable medical lead comprising:
`a lead body extending between a proximal end and a distal end;
`an electrode disposed proximate to the distal end of the lead body;
`a tine element extending from the lead body; and
`a marker positioned on the lead body proximate the tine element.
`Dkt. No. 111-22, Ex. 20 at MDT-00136385.
`The Examiner rejected those claims in view of U.S. Patent No. 5,902,330
`(“Ollivier”) (Dkt. No. 111-25, Ex. 23), a reference which discloses a structure with
`two tines along the lead, indisputably formed as a single structure1, finding that
`
`1 Neither Medtronic nor its expert disputes that Ollivier’s tine configuration is formed
`as a single structure. See, e.g., Dkt. No. 139-7 (Decl. of Medtronic Expert Dr. Chai)
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`“Ollivier discloses tine elements, 26.” Dkt. No. 111-22, Ex. 20 at MDT-00136321-323
`(6/1/2009 Office Action at 6-8.). The relevant figure in Ollivier is presented below:
`Medtronic To the Patent Office: Ollivier is not “a plurality of tine elements”
`
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`Dkt. No. 111-25, Ex. 23 (Ollivier), Fig. 1. See Ex. 40 at 16-24.
`To distinguish Ollivier, Medtronic amended the claims to recite “a plurality of
`tine elements,” [Dkt. No. 111-22, Ex. 20 at MDT-00136296 (9/1/09 Amendment at 2)]
`and told the PTO that “Ollivier fails to disclose or suggest an implantable medical lead
`comprising a plurality of tine elements extending from a lead body . . . as required by
`independent claims 1 and 14 as amended.” Id. at MDT-00136302-304. When
`Medtronic told the PTO that Ollivier was not a “plurality of tine elements,” it thereby
`clearly and unmistakably excluded from the scope of “plurality of tine elements”
`single structures with tines like Ollivier. Dkt. No. 113-1, Irazoqui Decl. ¶¶51-56.
`The problem is that neither the R&R nor Medtronic can explain how the
`construction adopted by the R&R would not mean that Ollivier now discloses the same
`“plurality of tine elements” that Medtronic told the Patent Office it does not disclose.
`As shown below, Ollivier could be argued to have two or more arbitrarily designated
`parts or portions—green and blue.2 Each of those portions has one or more tines,
`along the length of the lead body—the tines are indisputably at different longitudinal
`
`¶27 (“[R]egardless of whether the Ollivier reference discloses a tine element as a
`single structure . . .”). Axonics’ expert confirms it. Dkt. No. 113-1, Irazoqui Decl. ¶51.
`2 “Part or portion” has no clear meaning; the R&R’s construction permits Medtronic to
`argue it encompasses any arbitrary division of a single structure.
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`positions on the lead, to the extent that is a requirement of the construction. And they
`are formed as a single structure—a fact not disputed by Medtronic.
`The R&R’s Construction: Ollivier can be “a plurality of tine elements”
`
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`See Ex. 40 at 23-24. Even Medtronic’s named inventor agreed that this construction,
`which amounts to “two or more tines in a certain zone of a lead,” could include
`Ollivier in its scope. Ex. 403 (Slide 57). By permitting Medtronic to recapture what it
`unmistakably surrendered to obtain allowance, the R&R commits legal error.
`The R&R does not dispute that its construction would permit Medtronic to
`sweep into its scope single structures which Medtronic previously said were outside of
`“plurality of tine elements,” even though Axonics identified this problem in its briefing
`(see, e.g., Dkt. No. 138 at 6-8) and at hearing (Ex. 49 at 31:6-33:6, 46:3-49:1; Ex. 40
`at Slides 23, 24, 56, 57). Medtronic itself had no explanation when asked directly by
`the Special Master, demurring that the number of tine elements in any given structure
`was “more appropriate for factual determinations.” Ex. 49 (Tr. at 43:13-44:3). Not so;
`the legal effect of Medtronic’s disclaimer must be decided by the Court.
`Instead, the R&R summarily concludes that “the cited prosecution statements do
`not amount to a clear and unmistakable disclaimer of a plurality of tine elements being
`
`3 Exhibits numbered 40 and above are consecutively numbered after Axonics’ claim
`construction briefing exhibits and attached to the present filing.
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`formed as a single structure,” (R&R at 26), because “[n]owhere in this prosecution
`history regarding the Ollivier reference does Axonics show any statement by
`Medtronic that limited ‘plurality’ to meaning ‘separate’ or that otherwise precluded a
`plurality of tine elements from being formed as a single structure.” R&R at 23.4 The
`record shows otherwise. Axonics specifically demonstrated
`that Medtronic’s
`statements in the prosecution history “precluded a plurality of tine elements from being
`formed as a single structure,” (Ex. 40, slide 15) and the R&R’s insistence that Axonics
`must point to an explicit reference in the prosecution history to “separate” structures to
`show disclaimer misses the point. Disclaiming a single structure is the only thing that
`these unmistakable statements that Ollivier does not disclose a “plurality of tine
`elements” could possibly have meant. Neither the R&R nor Medtronic disputes that
`Ollivier’s tine structure discloses two tines, in different positions, along the length of
`the lead body. Neither the R&R nor Medtronic even suggests, let alone explains how,
`that could not be said to be a plurality of tine elements if a single structure is allowed
`to count as a plurality. As such, the only path left to Medtronic to distinguish Ollivier
`was on the ground it was a single structure, and that is exactly what Medtronic did. By
`1) amending the claims from “a tine element” (e.g., one thing) to a “plurality of tine
`elements” (i.e., two or more things), and 2) telling the Patent Office that Ollivier did
`not disclose a plurality of tine elements, Medtronic clearly, unmistakably, and
`irrevocably established that a single structure, no matter how many tines it has along
`the length of the lead, is not a plurality of tine elements. If a single structure with two
`tines could be a “plurality of tine elements,” then Medtronic’s argument to the Patent
`Office (its only remaining argument) could not have been made.
`Medtronic contended in its responsive brief and at hearing that it had “never
`amended the claims to recite a ‘plurality of tine elements’ to overcome any rejection”
`
`4 Similarly, the R&R further concludes, without explanation, that the “opinions of
`Axonics’s expert regarding this prosecution history” are “unpersuasive.” R&R at 23.
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`based on Ollivier, and had instead amended the claims based “on the location of
`marker positions in relation to the tine elements.” Dkt. No. 139 Medtronic Resp. Br.
`at 5-6 (emphases in original).5 Those assertions do not withstand scrutiny.
`The facts are these: faced with rejection of its claims in view of Ollivier,
`Medtronic indisputably amended the claims to recite a “plurality of tine elements” (in
`yellow, below) and told the Patent Office that “Ollivier fails to disclose or suggest an
`implantable medical lead comprising a plurality of tine elements extending from a
`lead body.” Dkt. No. 111-22, Ex. 20 at MDT-00136296 (9/1/09 Amendment at 2) at
`MDT-00136302-304. At the same time, it separately amended the claims to specify
`certain marker positions (in green, below).
`
`
`Dkt. No. 111-22, Ex. 20 at MDT-001363296. Medtronic’s decision to draw a second,
`separate distinction between its claims and the prior art does not negate its disavowal
`through the first distinction that Ollivier’s single structure is not a “plurality of tine
`elements.” The effect of telling the Patent Office that the claimed invention does not
`include X, and also does not include Y, is to disclaim both X and Y from the scope of
`the claims. See, e.g., Amgen Inc. v. Coherus BioSciences, Inc., 931 F.3d 1154, 1159-60
`
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`5 Medtronic contended at the hearing that this was new argument (Ex. 49. at 33:14-16).
`It was not; Axonics’ briefing demonstrates both the disclaimer, and that the
`construction would recapture surrendered claim scope. See, e.g., Dkt. No. 138 at 6-8.
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`(Fed. Cir. 2019) (“[S]eparate arguments [can] create separate estoppels . . . .”).
`tine
`There
`is more. Medtronic repeatedly disclaimed single-structure
`configurations, each of which Medtronic could contend are now encompassed by the
`R&R’s erroneous construction. Later in the prosecution of the 407 Application, the
`Examiner rejected Medtronic’s amended independent claim 1 (reciting, like the 314
`and 756 Patents, a “plurality of tine elements”) and dependent claim 26 (reciting
`“wherein the plurality of tine elements are longitudinally separated along the lead
`body,”), in view of U.S. Patent No. 5,957,966 (“Schroeppel”) (Dkt. No. 111-23,
`Ex. 21). Pointing to Schroeppel’s Figure 13, the Examiner concluded that Schroeppel
`discloses, inter alia, a “plurality of tine elements (e.g. Fig. 13, tine elements 72).” Dkt.
`No. 111-22, Ex. 20 (12/29/2009 Final Office Action at 2) at MDT-00136267. See also
`id. at MDT-00136207 (6/28/10 Appeal From Final Office Action at 3).
`Schroeppel discloses a cardiac lead with “one or more radially projecting tines
`70” that is “integrally molded” (i.e., a single structure) or coupled to the lead’s sleeve
`or a segment thereof, as shown in Schroeppel’s Figure 13, which shows two tines.
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`“As shown in FIGS. 13 and 14, the lead 10
`may be provided with one or more radially
`projecting tines 70 composed of a shape-
`memory polymeric material and either
`integrally molded with one of the segments,
`e.g. 28, as shown in FIGS. 13 and 14 . . ..”
`Dkt. No. 111-23, Ex. 21 at 8:31-36.
`Neither the R&R nor Medtronic disputes that Schroeppel’s “integrally molded” tine
`configuration is a single structure, as Schroeppel makes plain on its face and as
`confirmed by Axonics’ expert. Compare Dkt. No. 111-1 (Irazoqui Decl.) ¶58 with Dkt.
`No. 139-7 (Declaration of Medtronic expert Chai) ¶¶28-29.
`Medtronic objected to the rejection with the clear statement that Schroeppel’s
`single structure tine configuration was excluded from a “plurality of tine elements”:
`Schroeppel only discloses a single tine element with tines that share a
`longitudinal position along the length of the lead and fails to disclose or
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`suggest that the lead may include a plurality of tine elements, much less
`a plurality of tine elements longitudinally separated along the lead body.
`Dkt. No. 111-22, Ex. 20 at MDT-00136215 (6/28/10 Appeal at 11). In so doing,
`Medtronic, with “clarity and deliberateness”, again unmistakably disclaimed any
`reading of “plurality of tine elements” that would encompass a single tine structure.
`Genuine Enabling Tech. LLC v. Nintendo Co., 29 F.4th 1365, 1374 (Fed. Cir. 2022). In
`fact, Medtronic disavowed structures like Schroeppel repeatedly, later telling the
`Patent Office that “Borkan, Erlebacher, and Kroll fail to overcome the fundamental
`deficiencies in Schroeppel discussed with respect to independent claim 1” in that, like
`Schroeppel, they “fail to disclose or suggest . . . a plurality of tine elements extending
`from the lead body”). See id. at MDT-00136217. See Ex. 40 at 27-33.
`Let there be no mistake: the only way that Medtronic could argue that
`Schroeppel was a “single tine element” and not a “plurality of tine elements” (as it
`undeniably did), is that it was a single structure. It is beyond dispute that Schroeppel
`has multiple tines along the length of the lead; as with Ollivier, that would be a
`plurality of tine elements, if a single structure counts as a plurality. So Medtronic made
`the only argument available to it, which is that one thing is not two things, and that
`argument can only be made if a singular structure with multiple tines is not a “plurality
`of tine elements.” The law is clear that Medtronic is stuck with the result.
`Despite Medtronic’s unmistakable statement, in order to obtain allowance of its
`patents, that Schroeppel “only discloses a single tine element,” not a plurality of them,
`(Dkt. No. 111-22, Ex. 20 at MDT-00136215), the R&R’s construction impermissibly
`would permit Medtronic to argue it can recapture for infringement what it surrendered
`for patentability. Schroeppel now could be a “plurality of tine elements” under the
`R&R’s construction. As shown below, Schroeppel can arbitrarily be said to have two
`or more parts or portions—green and blue. Each of those portions has one or more
`tines, along the length of the lead body. And there is no dispute they are formed as a
`single structure. See Ex. 40 at 55, 53-54.
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`Again, the R&R does not deny or attempt to explain why the unambiguous record
`Axonics explained in detail in its briefing would not permit the R&R’s construction to
`erroneously recapture the very subject matter Medtronic had disclaimed.
`Instead, the R&R asserts that Medtronic’s statements regarding Schroeppel are
`not “a clear and unmistakable disclaimer of a plurality of tine elements being formed
`as a single structure.” R&R at 26. The R&R offers only two bases for this conclusion.
`First, the R&R states without explanation that no disclaimer of claim scope
`occurred because “Medtronic based its argument” to the patent office regarding
`Schroeppel “in part on ‘longitudinal position.’” R&R at 25. The R&R’s conclusion,
`based on arguments made by Medtronic in briefing that it had only distinguished
`Schroeppel on the basis of the longitudinal position of its tines, not that it was a single
`tine element (Dkt. No. 139 at 6), misreads what Medtronic actually said to the PTO.
`While Medtronic did tell the Patent Office that Schroeppel’s tines were not
`longitudinally separated, that is a second, distinct argument it made to the Patent
`Office, in addition to its first argument—that Schroeppel was only a “single tine
`element,” not a “plurality of tine elements.” Moreover, it made those arguments about
`different limitations in the claim. The Examiner’s rejection in the 407 Application in
`view of Schroeppel was made as to dependent claim 26, which recited “the
`implantable medical lead of claim 1, wherein the plurality of tine elements are
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`longitudinally separated along the lead body.” Dkt. No. 111-22, Ex. 20 at MDT-
`00136223. As a dependent claim, claim 26 incorporated all of the limitations of Claim
`1, including “a plurality of tine elements extending from the lead body,” unmodified
`by any longitudinal requirement. Medtronic made its first argument (“not a plurality of
`tine elements”) with respect to that standalone recitation; it made its second argument,
`regarding longitudinal separation, with respect to the second appearance of “plurality
`of tine elements” in the claim, in conjunction with those very words. As such, when
`Medtronic told the Patent Office that Schroeppel disclosed only a single tine element
`and therefore did not disclose a plurality of tine elements, “much less” a plurality of
`tine elements “longitudinally separated along the lead body”, it clearly and
`unmistakably excluded single structures like Schroeppel from both the “longitudinally
`separated” limitation of Claim 26, and the standalone “plurality of tine elements”
`incorporated from Claim 1. See, e.g., Amgen Inc. v. Coherus BioSciences, Inc., 931
`F.3d 1154, 1159-60 (Fed. Cir. 2019); Southwall Techs., Inc. v. Cardinal IG Co., 54
`F.3d 1570, 1583 (Fed. Cir. 1995) (“separate arguments create separate estoppels.”).
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`Ex. 40 at 27-32. Put simply, when an independent claim recites “apples,” and its
`dependent claim recites “wherein the apples are green apples”, and the applicant tells
`the Patent Office that a prior art reference does not even disclose apples, “much less”
`green apples, the disclaimed claim scope applies to all apples, not just green ones. As a
`matter of common sense and law, that is indisputably what it means here, too.
`Second, the R&R finds no disclaimer because “Medtronic argued that
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`Schroeppel did not disclose a plurality of tine elements at all.” R&R at 25. This is a
`non sequitur. The R&R’s construction is in total contradiction to that statement,
`because, as demonstrated, the construction would permit Medtronic to contend the
`term includes single structures like Schroeppel within its scope. Instead, Medtronic’s
`statements support Axonics’ proposed construction: the only basis for Medtronic to
`argue that Schroeppel was only a “single tine element” and not a “plurality” at all, is
`that Schroeppel was a single structure, and so a plurality of tine elements requires two
`or more structures with tines, not one. In other words, no matter how many tines a
`single structure has, it is not a plurality of tine elements. Only Axonics’ construction
`preserves what Medtronic indisputably surrendered to obtain allowance.
`None of the R&R’s other bases for its erroneous construction of this term
`withstand scrutiny or explain why a construction that permits Medtronic to argue it
`encompasses disclaimed tine configurations can be the correct one. The R&R finds
`that, because Claim 1 of the 756 Patent recites, among other things, that the plurality of
`tine elements are “separate from each other,” this “weighs at least somewhat against
`Axonics’s proposal to imbue every usage of the disputed term with a requirement of
`separateness.” R&R at 18-19. As Axonics explained at the hearing and in its briefing6,
`however, Claim 1 (then Claim 19) of the 756 Patent was amended with that language,
`but not to distinctly claim a multiple-structure embodiment. Instead, the claim was
`amended to recite “wherein the plurality of M tine elements are separate from and
`axially displaced from each other and from each of the P stimulation electrodes” to
`avoid a prior art reference (“Borkan”) which located stimulation electrodes between
`tine elements. That is why, at the same time Medtronic made this amendment, it also
`added to the claim “wherein no electrodes are positioned between adjacent tine
`
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`6 The R&R contends that Axonics’ arguments regarding the prosecution history of the
`756 Patent “were not presented in Axonics’s briefing.” R&R at 21. Of course they
`were. See, e.g., Dkt. No. 138 at 5:15-6:11.
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`elements of the plurality of M tine elements.” Dkt. No. 138-2, Ex. 34 (756 File
`History, 9/7/2010 Amendment, at 2 (MDT-00001004)). It is true that the amendment
`to add “adjacent tine elements” confirms that “tine elements” are separate structures,
`since “adjacent” means “next to or adjoining something else.” However, that
`demonstrates only that the R&R’s construction is wrong, because Medtronic added
`that same “adjacent tine elements