Case 8:19-cv-02115-DOC-JDE Document 163-1 Filed 09/13/22 Page 1 of 86 Page ID
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`DAVID KEYZER (SB# 248585)
`david@keyzerlaw.com
`LAW OFFICE OF DAVID KEYZER, P.C.
`5170 Golden Foothill Parkway
`El Dorado Hills, CA 95762
`Telephone: (916) 243-5259
`Facsimile: (916) 404-0436
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`UNITED STATES DISTRICT COURT
`CENTRAL DISTRICT OF CALIFORNIA
`SOUTHERN DIVISION
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` Case No. 8:19-CV-02115-DOC-JDE
`
` Hon. David O. Carter
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` Special Master David Keyzer
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` SPECIAL MASTER
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` REPORT AND RECOMMENDATION
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` ON CLAIM CONSTRUCTION
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`MEDTRONIC, INC., et al.,
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`AXONICS MODULATION
`TECHNOLOGIES, INC.,
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`Plaintiffs,
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`Defendant.
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`The undersigned, having been appointed Special Master pursuant to Rule 53 of the
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`Federal Rules of Civil Procedure to conduct claim construction proceedings in the
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`above-captioned case, submits this Report and Recommendation on Claim Construction.
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`SPECIAL MASTER REPORT AND RECOMMENDATION ON CLAIM CONSTRUCTION - 1
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`
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`Axonics Exhibit 1024
`Axonics, Inc. v. Medtronic, Inc.
`IPR2020-00712
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`Page 1 of 86
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`Table of Contents
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`I. INTRODUCTION ................................................................................................... 2
`II. THE PATENTS-IN-SUIT ..................................................................................... 4
`III. LEGAL STANDARDS ........................................................................................ 6
`IV. AGREED TERMS ................................................................................................ 7
`V. LEVEL OF ORDINARY SKILL IN THE ART ................................................. 9
`VI. THE DISPUTED TERMS ................................................................................. 11
`A. “plurality of tine elements” ......................................................................... 11
`B. “indicative of” .............................................................................................. 28
`C. “adjustable assembly adapted to adjust efficiency of energy transfer
`between the primary coil and the secondary coil” ............................................ 42
`D. “programmable limit” .................................................................................. 50
`E. “value associated with said current” ............................................................ 63
`F. “wherein said [predetermined] current [passing through / in] said
`internal power source declines as said voltage of said internal power source
`increases during a charging cycle” .................................................................... 75
`VII. CONCLUSION ................................................................................................. 86
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`I. INTRODUCTION
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`Plaintiffs Medtronic, Inc., Medtronic Puerto Rico Operations Co., Medtronic
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`Logistics LLC, and Medtronic USA, Inc. (“Plaintiff” or “Medtronic”) asserts seven
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`patents against Defendant Axonics, Inc. (“Defendant” or “Axonics”). (Dkt. 122 at 1; see
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`Dkt. 28.) Medtronic submits: “The patented inventions are embodied by Medtronic’s
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`innovative rechargeable, implantable sacral neuromodulation system known as InterStim
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`Micro, which is used by patients across the country to help to control symptoms of
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`overactive bladder, non-obstructive urinary retention, and chronic fecal incontinence
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`through direct modulation of sacral nerve activity.” (Dkt. 122 at 1.) Axonics submits:
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`“Each of the asserted patents concerns a narrow purported improvement to
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`implantable medical devices for neurostimulation.” (Dkt. 111 at 1.)
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`The patents-in-suit are United States Patents No. 8,036,756 (“the ’756 Patent”),
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`8,626,314 (“the ’314 Patent”), 9,463,324 (“the ’324 Patent”), 9,821,112 (“the ’112
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`Patent”), 8,738,148 (“the ’148 Patent”), 8,457,758 (“the ’758 Patent”), and 7,774,069
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`(“the ’069 Patent”). Dkt. 122 at 1; see Dkt. 28, Amended Complaint.
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`The parties submitted their respective Opening Claim Construction Briefs on
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`July 1, 2022 (Dkt. 111 (Axonics); Dkt. 122 (Medtronic)). The parties submitted their
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`respective Responsive Claim Construction Briefs on July 15, 2022 (Dkt. 138 (Axonics);
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`Dkt. 139 (Medtronic)). Also before the Special Master is the parties’ July 1, 2022 First
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`Amended Joint Claim Construction Statement (Dkt. 110).
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`Pursuant to the Court’s April 26, 2022 Amended Order Appointing Special Master
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`(Dkt. 100), the Special Master entered orders regarding the claim construction
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`proceedings1 and conducted a claim construction hearing on September 7, 2022. (See
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`Dkt. 158-1, Special Master Minutes.) Also, on September 6, 2022, the Special Master
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`provided counsel for both sides with a Tentative Special Master Report and
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`1 (Dkt. 108-1, June 9, 2022 Special Master Order No. SM-1 (setting deadlines for claim
`construction briefing and setting claim construction hearing); Dkt. 143-1, July 30, 2022
`Special Master Order No. SM-7 (resetting claim construction hearing).)
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`Recommendation on Claim Construction to assist the parties in focusing their oral
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`arguments. The tentative constructions are noted below within the discussion for each
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`term.
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`Based on the above-cited briefing as well as the oral arguments presented by
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`counsel at the September 7, 2022 hearing, the Special Master construes the disputed
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`terms as set forth herein.
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`II. THE PATENTS-IN-SUIT
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`The ’756 Patent, titled “Implantable Medical Electrical Stimulation Lead Fixation
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`Method and Apparatus,” issued on October 11, 2011, and bears an earliest priority date
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`of August 31, 2001. The ’314 Patent resulted from a continuation of a continuation of
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`the ’756 Patent. Medtronic refers to these as “the tined lead patents” and submits that
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`these patents “relate to a method and apparatus for stimulation of the sacral nerves.”
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`Dkt. 122 at 2. The Abstract of the ’756 Patent, for example, states:
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`An implantable medical electrical lead particularly for stimulation of the
`sacral nerves comprises a lead body extending between a distal end and a
`proximal end, and the distal end having at least one electrode of an
`electrode array extending longitudinally from the distal end toward the
`proximal end. The lead body at its proximal end may be coupled to a pulse
`generator, additional intermediate wiring, or other stimulation device. A
`fixation mechanism is formed on or integrally with the lead body proximal
`to the electrode array that is adapted to be implanted in and engage
`subcutaneous tissue, particularly muscle tissue, to inhibit axial movement of
`the lead body and dislodgement of the stimulation electrodes.
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`The ’324 Patent, titled “Inductively Rechargeable External Energy Source,
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`Charger, System and Method for a Transcutaneous Inductive Charger for an Implantable
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`Medical Device,” issued on October 11, 2016, and bears an earliest priority date of
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`October 2, 2003. The ’112 Patent resulted from a continuation of the ’324 Patent.
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`Medtronic refers to these as “the temperature sensitive recharge patents” and submits
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`that these patents relate to using an external device to charge an implanted medical
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`device transcutaneously and doing so with the aid of a temperature sensor to limit the
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`temperature of the external device. Dkt. 122 at 3–4. The Abstract of the ’324 Patent
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`states:
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`A mechanism for transferring energy from an external power source to an
`implantable medical device is disclosed. A sensor may be used to measure
`a parameter that correlates to a temperature of the system that occurs during
`the transcutaneous coupling of energy. For example, the sensor may
`measure temperature of a surface of an antenna of the external power
`source. The measured parameter may then be compared to a programmable
`limit. A control circuit such as may be provided by the external power
`source may then control the temperature based on the comparison. The
`programmable limit may be, for example, under software control so that the
`temperature occurring during transcutaneous coupling of energy may be
`modified to fit then-current circumstances.
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`The ’069 Patent, titled “Alignment Indication for Transcutaneous Energy
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`Transfer,” issued on August 10, 2010, and bears an earliest priority date of April 29,
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`2005. The ’758 Patent resulted from a continuation of a division of the ’069 Patent. The
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`’148 Patent resulted from a continuation of the ’758 Patent. Medtronic refers to these as
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`“the charge control patents” and submits that “[t]o improve the efficiency of recharge,
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`the patent[s] describe[], among other things, automatically varying the power output of
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`this external charging device based on two or more values associated with the current
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`through the internal battery of the implantable medical device (i.e., values such as, but
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`not limited to, current and voltage).” Dkt. 122 at 4.
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`The Abstract of the ’069 Patent states:
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`System for transcutaneous energy transfer. An implantable medical device,
`adapted to be implanted in a patient, has componentry for providing a
`therapeutic output. The implantable medical device has an internal power
`source and a secondary coil operatively coupled to the internal power
`source. An external power source, having a primary coil, provides energy
`to the implantable medical device when the primary coil of the external
`power source is placed in proximity of the secondary coil of the implantable
`medical device and thereby generates a current in the internal power source.
`An alignment indicator reports the alignment as a function of the current
`generated in the internal power source with a predetermined value
`associated with an expected alignment between the primary coil and
`secondary coil.
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`III. LEGAL STANDARDS
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`The Court has set forth relevant legal principles in, for example, Spigen Korea Co.
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`Ltd. v. Lijun Liu, et al., No. 2:16-CV-09185-DOC-DFM, Dkt. 215, 2018 WL 8130608,
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`slip op. at 10–11 (C.D. Cal. Dec. 12, 2018), and Limestone Memory Systems, LLC v.
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`Micron Technology, Inc., No. 8:15-CV-00278-DOC-KES, Dkt. 242, 2019 WL 6655273,
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`slip op. at 2–8 (C.D. Cal. Sept. 11, 2019). For example, the Court noted that “[i]t is a
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`bedrock principle of patent law that the claims of a patent define the invention to which
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`the patentee is entitled the right to exclude.” Spigen Korea, No. 2:16-CV-09185-DOC-
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`DFM, Dkt. 215, slip op. at 10 (quoting Phillips v. AWH Corp., 415 F.3d 1303, 1312
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`(Fed. Cir. 2005) (en banc)). The Court also noted that “the terms must be read in the
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`context of the entire patent.” Id. (citing Phillips, 415 F.3d at 1314).
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`IV. AGREED TERMS
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`In their July 1, 2022 First Amended Joint Claim Construction Statement, the
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`parties submit the following agreed-upon constructions:
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`Term
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`Agreed Construction
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`“[wherein] said [external power
`source/charging unit] automatically
`[varies/varying] its power output based
`on a value associated with said current
`passing through said internal battery”
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`“wherein said [external power source/
`automatically varying step] automatically
`varies its power output based on a signal
`proportional to said current passing
`through said internal battery”
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`(’148 Patent, Claims 3, 9, 15)
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`“[wherein] said [external power
`source/charging unit] automatically
`[varies/varying] its power output based
`on a value associated with said current
`passing through said internal battery”
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`“wherein said [external power source/
`automatically varying step] automatically
`varies its power [source] output based on
`a measured voltage associated with said
`current passing through said internal
`battery”
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`(’148 Patent, Claims 6, 12, 18)
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`These claims each require two
`separate inputs to the external power
`source or charging unit.
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`These limitations in combination
`require both (1) “a value associated
`with said current passing through said
`internal battery” and (2) “a signal
`proportional to said current passing
`through said internal battery.”
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`These claims each require two
`separate inputs to the external power
`source or charging unit.
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`These limitations in combination
`require both (1) “a value associated
`with said current passing through said
`internal battery” and (2) “a measured
`voltage associated with said current
`passing through said internal battery.”
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`SPECIAL MASTER REPORT AND RECOMMENDATION ON CLAIM CONSTRUCTION - 7
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`These claims each require two
`separate inputs to the external power
`source or charging unit.
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`These limitations in combination
`require both (1) “a value associated
`with said current passing through said
`internal power source” and (2) “a
`measured current associated with said
`current passing through said internal
`power source.”
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`Each wherein clause of these
`dependent claims requires a separate
`input from those in the independent
`claims.
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`Plain and ordinary meaning; not
`subject to 35 U.S.C. § 112(f).
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`“[wherein] said [external power
`source/charging unit] automatically
`[varies/varying] its power output based
`on a value associated with said current
`passing through said internal power
`source”
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`“wherein said [external power
`source/automatically varying step]
`automatically varies its power output
`based on a measured current associated
`with said current passing through said
`internal power source”
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`(’758 Patent, Claims 1, 5, 9)
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`“wherein said [external power source/
`automatically varying step] automatically
`varies its power output based on a
`[current/voltage] proportional to said
`current passing through said internal
`battery”
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`(’148 Patent, Claims 4, 5, 10, 11, 16, 17)
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`“an external charging device configured
`to transcutaneously transfer energy to the
`implantable medical device”
`(’112 Patent, Claim 1)
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`“transferring, via an external charging
`device, energy transcutaneously to an
`implantable medical device”
`(’112 Patent, Claim [8])
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`(Dkt. 110 at 2–3 (footnotes omitted).)
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`V. LEVEL OF ORDINARY SKILL IN THE ART
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`Axonics submits: “A person of ordinary skill in the art (‘POSITA’) in the field of
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`the 314 and 756 Patents by November 9, 2001, would have had (1) at least a bachelor’s
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`degree in biomedical engineering, electrical engineering, mechanical engineering, or
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`equivalent coursework, and (2) at least two years of experience researching or
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`developing active, implantable medical devices.”
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`Medtronic submits:
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`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, 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.
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`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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`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
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`experience in the industry working with implantable medical devices such
`as cardiac pacemakers or defibrillators.” Ex. CC, IPR2020-00712 FWD at
`15–16.
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`(Dkt. 139 at 1–2.)
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`Axonics argues: “Although the parties dispute the level of ordinary skill, a person
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`of ordinary skill in the art under either proposal would reach the same conclusion
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`regarding the meaning of disputed terms.” (Dkt. 111 at 2 n.2 (citing Dkt. 125, July 1,
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`2022 Irazoqui Decl. at ¶ 32).)
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`The PTAB addressed the level of ordinary skill in the art primarily in relation to
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`evaluating arguments regarding invalidity such as obviousness. The different proposals
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`presented by the parties regarding level of ordinary skill in the art do not significantly
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`affect the present claim construction analysis. That is, under either side’s proposal for
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`the level of ordinary skill in the art, the same claim constructions would be reached
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`herein.
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`VI. THE DISPUTED TERMS
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`A. “plurality of tine elements”
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`Medtronic’s Proposal
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`“plurality of tine elements”
`’756 Patent, Claim 14;
`’314 Patent, Claims 1, 7, 11, 18, 20, 21
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`Axonics’s Proposal
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`Two or more structures to which one or
`more tines are attached
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`Two or more parts or portions that
`include tines along the length of the
`lead body and which may form a
`single structure
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`(Dkt. 110 at 4; Dkt. 111 at 2; Dkt. 122 at 5; Dkt. 138 at 1; Dkt. 139 at 2.)
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`On September 6, 2022, the Special Master provided the parties with the following
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`tentative construction: “two or more parts or portions (each of which includes one or
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`more tines) that are positioned along the length of the lead body and that may be formed
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`as a single structure or as multiple structures.”
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`(1) The Parties’ Positions
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`Medtronic cites disclosure in the specification that tine elements can be formed
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`together as a single structure. Dkt. 122 at 5–6. Medtronic argues that Axonics, despite
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`having argued otherwise in IPR proceedings, “is attempting to limit the claims to only
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`certain depicted embodiments.” Id. at 6. “Moreover,” Medtronic argues, “the claim
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`language itself confirms that the disputed term does not require separate structures.” Id.
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`(citing ’756 Patent at Cls. 1 & 14; citing dictionaries).
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`Case 8:19-cv-02115-DOC-JDE Document 163-1 Filed 09/13/22 Page 12 of 86 Page ID
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`Axonics argues: “Common sense, the plain language of the claims in view of the
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`specification, and the prosecution history all confirm that Medtronic is wrong. Instead, a
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`‘plurality’ of tine elements can be met only by two or more structures to which tines are
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`attached, as Axonics has proposed.” (Dkt. 111 at 2–3; see id. at 3–8.) Axonics also
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`submits that “[a]dopting the proper construction disposes of the infringement issue,
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`because there can be no dispute that the tines of the accused Axonics product are part of
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`a single structure, cut from a single piece of material, that wraps around the Axonics
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`lead.” (Id. at 3 (footnote omitted).)
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`Medtronic responds that consideration of the infringement issues raised by
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`Axonics would be improper as part of these claim construction proceedings, and
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`Medtronic argues that “[t]he claim language and specification are dispositive here, and
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`the file history is entirely consistent.” (Dkt. 139 at 2.) Medtronic emphasizes that
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`“every independent claim of both the ’756 and ’314 patents requires a ‘plurality of tine
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`elements,’ but only one, unasserted independent claim 1 of the ’756 patent, requires that
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`the ‘plurality of [] tine elements’ must be ‘separate from . . . each other.’” (Id. at 3
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`(citation and footnote omitted).) Medtronic argues that Axonics’s proposal cannot be
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`correct because it would render the recital of “separate” superfluous in Claim 1 of the
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`’756 Patent. (Id.) Medtronic also argues that “[t]here is no basis to dismiss the
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`embodiment of a ‘plurality of tine elements’ formed as a ‘single structure’ as
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`unclaimed except for Axonics’ desired but unsupported conclusion that term must mean
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`SPECIAL MASTER REPORT AND RECOMMENDATION ON CLAIM CONSTRUCTION - 12
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`Page 12 of 86
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`Case 8:19-cv-02115-DOC-JDE Document 163-1 Filed 09/13/22 Page 13 of 86 Page ID
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`two or more structures.” (Id. at 4 (citation omitted).)
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`As to the prosecution history cited by Axonics, Medtronic responds that “there
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`was no disclaimer of any kind—much less one that is ‘clear and unmistakable’—during
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`the prosecution of a separate application that Axonics refers to, U.S. Application No.
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`11/589,407, regarding a ‘plurality of tine elements.’” (Dkt. 139 at 5 (footnote omitted);
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`see id. at 5–6.) Finally, Medtronic argues that the opinions of Axonics’s expert should
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`be given no weight because “[c]laim construction is an analysis based on legal principles
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`and is within the province of the Special Master, not an expert,” and “Axonics does not
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`explain how he is qualified to testify about the understanding of a POSITA when the
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`PTAB found that experience in sacral neuromodulation was necessary.” (Id. at 6 & 7
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`(citations omitted).)
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`Axonics responds that “common sense, the plain language of the claims in view of
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`the specification, and the prosecution history all confirm that a ‘plurality’ of tine
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`elements can be met only by two or more structures to which tines are attached, as
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`Axonics has proposed.” (Dkt. 138 at 1.) Axonics argues that the disclosures cited by
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`Medtronic “are at most an unclaimed embodiment,” “[a]nd where the claims recite a
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`‘tine element’ in singular form, they refer to ‘each tine element’ (see, e.g., 314 Claims 1,
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`11, 18; 756 Claim 14), thereby referring to them as distinct, individual structures within
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`a group of multiple such structures.” (Id. at 2 (citation omitted).) Axonics also argues
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`SPECIAL MASTER REPORT AND RECOMMENDATION ON CLAIM CONSTRUCTION - 13
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`Page 13 of 86
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`Case 8:19-cv-02115-DOC-JDE Document 163-1 Filed 09/13/22 Page 14 of 86 Page ID
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`that, during prosecution, “the inventors repeatedly told the Patent Office that a ‘plurality
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`of tine elements’ excludes tine elements formed as a single structure (as Medtronic’s
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`preferred specification passages suggest) and disclaimed any meaning of the term that
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`would include such a structure.” (Id. at 3.) As to Claim 1 of the ’756 Patent, cited by
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`Medtronic, Axonics responds:
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`Claim 1 of the 756 Patent differs substantially from Claim 14, and the
`claims of the 314 Patent, including for example that Claim 1 recites
`additional method steps and claims N tines rather than a “plurality of tines.”
`Moreover, the Federal Circuit has made clear that claim differentiation is
`only a “tool,” and “cannot enlarge the meaning of a claim beyond that
`which is supported by the patent documents or relieve any claim of
`limitations imposed by the prosecution history,” such as the statements
`made by the applicants here, excluding a “single structure” from the scope
`of a “plurality of tine elements.” Indacon, Inc. v. Facebook, Inc., 824 F.3d
`1352, 1358 (Fed. Cir. 2016).
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`(Dkt. 138 at 5.) Axonics argues that Medtronic’s proposed construction would permit
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`arbitrary line-drawing that would encompass what Medtronic referred to as a “single tine
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`element” during prosecution. (Id. at 8.)
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`(2) Analysis
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`Claim 1 of the ’314 Patent, for example, recites (emphasis added):
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`1. A system comprising:
`an implantable medical lead comprising:
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`a lead body extending between a proximal end and a distal end;
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`a plurality of conductors within the lead body;
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`a plurality of electrodes, wherein each electrode is electrically
`connected to a conductor of the plurality of conductors; and
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`a plurality of tine elements extending from the lead body, wherein all
`tine elements of the plurality of tine elements are positioned between a most
`proximal electrode of the plurality of electrodes and the proximal end of the
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`SPECIAL MASTER REPORT AND RECOMMENDATION ON CLAIM CONSTRUCTION - 14
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`Page 14 of 86
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`Case 8:19-cv-02115-DOC-JDE Document 163-1 Filed 09/13/22 Page 15 of 86 Page ID
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`lead body, each tine element comprising a plurality of flexible, pliant tines,
`each tine having a tine width and thickness and extending a tine length from
`an attached tine end to a free tine end, the attached tine end attached to the
`lead body from a tine attachment site and supporting the tine extending
`outwardly of the lead body and proximally toward the lead proximal end,
`wherein the plurality of tines of the plurality of tine elements are adapted to
`be folded inward against the lead body when fitted into and constrained by a
`lumen of an introducer without overlapping one another and deploy
`outward to engage body tissue when the introducer is withdrawn to release
`the plurality of tines, wherein the plurality of tine elements is separate from
`and axially displaced from the plurality of electrodes.
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`On one hand, Axonics submits authority that the word “plurality,” “when used in a
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`claim, refers to two or more items, absent some indication to the contrary.” Dayco
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`Prods. v. Total Containment, Inc., 258 F.3d 1317, 1327–28 (Fed. Cir. 2001) (citing York
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`Prods., Inc. v. Cent. Tractor Farm & Family Ctr., 99 F.3d 1568, 1575 (Fed. Cir. 1996)
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`(“The term means, simply, ‘the state of being plural.’”) (citing dictionary)); see Apple
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`Inc. v. MPH Techs. Oy, 28 F.4th 254, 261–62 (Fed. Cir. 2022) (finding “‘information
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`fields’ is plural and, thus, presumably requires more than one field,” and “[i]n
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`accordance with common English usage, we presume a plural term refers to two or more
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`items”) (citing Leggett & Platt, Inc. v. Hickory Springs Mfg. Co., 285 F.3d 1353, 1357
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`(Fed. Cir. 2002) (“[T]he claim recites ‘support wires’ in the plural, thus requiring more
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`than one welded ‘support wire.’”)).
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`Axonics also highlights the usage of the word “each” in these claims, which
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`Axonics argues implies multiple distinct structures. (Dkt. 138 at 2 (citing Medtronic,
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`Inc. v. Guidant Corp., Nos. Civ. 00-1473 (MJD/JGL), Civ. 00-2503 (MJD/JGL), 2004
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`SPECIAL MASTER REPORT AND RECOMMENDATION ON CLAIM CONSTRUCTION - 15
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`Page 15 of 86
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`Case 8:19-cv-02115-DOC-JDE Document 163-1 Filed 09/13/22 Page 16 of 86 Page ID
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`WL 1179338, at *42 (D. Minn. May 25, 2004) (“The ordinary meaning of the word
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`‘each’ is ‘every one of two or more considered individually or one by one.’”).)
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`The specification discloses, for example, a “tine element array 120” that includes
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`“tine elements 125, 130, 135, 140,” each of which includes “tines”:
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`A fixation mechanism is formed on the lead body 15 proximal to the
`electrode array 20 in the distal lead portion 50 that is adapted to be
`implanted in and engage subcutaneous tissue to inhibit axial movement of
`the lead body 15 and dislodgement of the stimulation electrodes 25, 30, 35
`and 40. The fixation mechanism comprises four tine elements 125, 130,
`135 and 140 arrayed in a tine element array 120 in the distal lead portion 50
`of the lead body 15. . . .
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`Exemplary tine elements are depicted in FIGS. 2–4, where M=4 and N=4,
`for example. Each tine element 125, 130, 135 and 140 comprises at least
`one flexible, pliant, tine, and four such tines 145, 150, 155 and 160 or 145',
`150', 155' and 160', are depicted in these examples. * * *
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`In the depicted preferred embodiments, the tine elements 125, 130, 135 and
`140 or 125', 130', 135' and 140' preferably comprise a tine mounting band
`175 or 175' encircling the lead body with the tines extending from
`respective attached tine ends or roots disposed apart from one another,
`preferably at equal spacing, around the tine mounting band 175 or 175'.
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`’756 Patent at 9:61–10:29; see ’314 Patent at 10:12–47; see also id. at Figs. 1, 9 & 10.
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`Figure 2 of the ’756 Patent illustrates the “tine elements 125, 130, 135, 140” as
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`being separated from one another:
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`SPECIAL MASTER REPORT AND RECOMMENDATION ON CLAIM CONSTRUCTION - 16
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`Page 16 of 86
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`Case 8:19-cv-02115-DOC-JDE Document 163-1 Filed 09/13/22 Page 17 of 86 Page ID
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`Axonics urges that the specification describes Figures 3 and 4 of the ’756 Patent
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`as each showing a single “tine element” and discloses that when multiple such elements
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`are “arrayed in a tine element array 120 in the distal lead 15 portion 50 of the lead body
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`15” (id.), they comprise a “plurality of tine elements.” See id. at 6:5–9 (“The fixation
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`mechanism comprises a plurality M of tine elements arrayed in a tine element array
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`along a segment of the lead proximal to the stimulation electrode array.”).
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`On the other hand, the specification further discloses that “tine elements” could be
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`formed “as a single structure”:
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`[I]n FIG. 9, the tine elements 225, 230, 235, and 240 are formed as
`described above with respect to tine elements 125, 130, 135, and 140 or
`125', 130', 135', and 140' as individual elements mounted in the tine element
`array 220 or integrally.
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