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`UNITED STATES DISTRICT COURT
`CENTRAL DISTRICT OF CALIFORNIA
`SOUTHERN DIVISION
`
`Case No. 8:19-cv-02115-DOC-JDE
`
`REDACTED VERSION OF
`DOCUMENT PROPOSED TO BE
`FILED UNDER SEAL
`
`MEDTRONIC, INC.; MEDTRONIC
`PUERTO RICO OPERATIONS CO.;
`MEDTRONIC LOGISTICS, LLC;
`MEDTRONIC USA, INC.,
`
`Plaintiff,
`
`v.
`
`AXONICS MODULATION
`TECHNOLOGIES, INC.,
`
`Defendant.
`
`DECLARATION OF DR. PEDRO IRAZOQUI IN SUPPORT OF AXONICS’
`OPENING CLAIM CONSTRUCTION BRIEF
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`IRAZOQUI DECLARATION
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`CASE NO. 8:19-CV-02115-DOC-JDE
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`Axonics Exhibit 1031
`Axonics, Inc. v. Medtronic, Inc.
`IPR2020-00712
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`I.
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`TABLE OF CONTENTS
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`INTRODUCTION ......................................................................................... 1
`A.
`Education and Professional Experience .............................................. 1
`B.
`Compensation ...................................................................................... 3
`C. Materials Reviewed and Relied Upon ................................................. 3
`D.
`Legal Principles ................................................................................... 3
`E.
`Level of Ordinary Skill in the Art ....................................................... 5
`1.
`314 and 756 Patents .................................................................. 5
`2.
`324 Patent .................................................................................. 8
`3.
`148 and 758 Patents .................................................................. 8
`II.
`OVERVIEW OF PATENTS-IN-SUIT ......................................................... 9
`III. CLAIM CONSTRUCTION ........................................................................ 13
`A. Disputed Term: “plurality of tine elements” (756 Patent claim 14;
`314 Patent claims 1, 7, 11, 18, 20, 21) .............................................. 13
`B.
`Disputed Term: “indicative of” (324 Patent claims 1, 12, 20) .......... 18
`C.
`12) ..................................................................................................... 23
`
`Disputed Term: “value associated with said current” (148 Patent
`Claims 3, 6, 9, 12, 15, 18; 758 Patent Claims 1, 2, 4, 5, 6, 8, 9, 10,
`
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`IRAZOQUI DECLARATION
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`I.
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`I, Dr. Pedro Irazoqui, declare as follows:
`INTRODUCTION
`1.
`Counsel for Axonics, Inc. (“Axonics”) have retained me as an expert in
`this matter to offer opinions regarding certain claim construction issues for U.S. Patent
`Nos. 8,626,314 (“the 314 Patent”), 8,036,756 (“the 756 Patent”), 9,463,324 (“the 324
`Patent”), 8,738,148 (“the 148 Patent”), and 8,457,758 (“the 758 Patent”).
`2.
`I submit this declaration based on my personal knowledge and in support
`of Axonics’ proposed claim constructions. If called upon as a witness, I could
`competently testify to the truth of each statement herein.
`3.
`This declaration contains statements of my opinions formed to date and
`the bases and reasons for those opinions. I may offer additional opinions based on
`further review of materials in this case, to rebut opinions offered by any Medtronic
`expert, and to address issues raised by Medtronic in claim construction briefing to the
`extent permitted by the Court.
`4.
`In forming my opinion expressed herein, I have reviewed the above-
`mentioned patents, as well as their prosecution histories, along with dictionaries both
`technical and non-technical, and other sources that I identify in the paragraphs below.
`A. Education and Professional Experience
`5. My qualifications and credentials are fully set forth in my curriculum
`vitae, attached as Attachment 1. I am both an electrical and a biomedical engineer and
`the Professor and Head of Electrical and Computer Engineering at the Johns Hopkins
`University.
`6.
`I received a Bachelor of Science degree in Electrical Engineering in 1997
`from the University of New Hampshire. In 1999, I received a Master of Science degree
`in Electrical Engineering from the University of New Hampshire. In 2003, I received a
`Ph.D. in Biomedical Engineering from the University of California, Los Angeles.
`7.
`In 2005, I became a Professor of Biomedical Engineering at Purdue
`University. While there, I founded the Center For Implantable Devices (“CID”), an
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`internationally recognized research center in implantable medical devices. Founded in
`2010, the Center for Implantable Devices (CID) leads in the research, development,
`and translation of implantable medical devices through collaborations between Purdue
`University faculty and national and international clinical and commercial partners.
`Over the course of my time there, CID grew to include more than 20 faculty members,
`including five new tenure-track faculty hires, and over $30M in extramural funding. In
`2021, I joined Johns Hopkins University as Professor and Head of Electrical and
`Computer Engineering in the Whiting School of Engineering.
`8.
`Since 1999, my work has focused on the modular design and use of
`biological implants for the study and treatment of neural pathologies. Module types
`include those for: single and population neural recording; cortical and peripheral nerve
`excitation, inhibition, and blocking; muscle, including cardiac, digestive, and
`peripheral activity recording and control; and biochemical marker sensing. During that
`time, I have researched and worked on engineering challenges in: open and closed-
`loop sensing and/or stimulation; wireless power, storage, and data transfer; and
`machine learning for autonomous personalized therapy. When combined into distinct
`embedded systems, these modules enable us, in partnership with scientists and
`clinicians working with our lab, to conduct high impact and heretofore impracticable
`experiments. Specific research and clinical applications explored include epilepsy,
`glaucoma, gastric motility, and photopharmacology.
`9.
`I have continued to teach courses in biomedical engineering, electrical
`engineering, bioelectricity, medical device design, analog integrated circuit design for
`biomedical applications, and biomedical signal processing. In addition, I have an
`active funded research program at Johns Hopkins, which involves undergraduate and
`graduate students.
`10.
`I have published more than 124 papers in refereed and peer-reviewed
`journals and conference proceedings, written 5 book chapters, and given over 50
`invited talks. This includes talks on neuromodulation therapy for urinary incontinence,
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`including P. Irazoqui, “Modulating Urinary Incontinence,” Glaxo-Smith Kline, Los
`Angeles, CA, Spring 2015. In 2015, I also received a grant from Glaxo Smith Kline in
`2015 to study closed-loop neuromodulation of urinary incontinence.”
`11.
`I am a named inventor on 13 granted U.S. patents and numerous pending
`patents. I have also served as an Associate Editor of the Journal of Neural Engineering
`from 2016-2021, Associate Editor of the flagship IEEE Transactions on Biomedical
`Engineering since 2006, and in 2023 will be Conference Chair of the IEEE Neural
`Engineering conference. I was made a Fellow of the American Institute for Medical
`and Biological Engineering in 2016, and received the College of Engineering Faculty
`Excellence Award for Research at Purdue in 2019.
`B. Compensation
`12.
`I am being compensated for my time in connection with this case at my
`standard legal consulting rate, which is $695 per hour. I have no personal or financial
`interest in the outcome of this proceeding.
`C. Materials Reviewed and Relied Upon
`13.
`In formulating my opinions, I have considered the 314, 756, 324, 112,
`148, 758, and 069 Patents (attached hereto as Exhibits 1-71), their corresponding file
`histories, all documents cited in this declaration, and the Joint Claim Construction
`Chart and the documents attached thereto. If the parties alter any of the proposed
`constructions after this declaration is submitted, I may submit a supplemental
`declaration addressing any new constructions, as appropriate and if permitted.
`D. Legal Principles
`14.
`I am not a lawyer. I have been provided with an understanding of the legal
`principles that govern claim construction and patent validity. I have conducted my
`analysis in conformance with these principles. I set forth those understandings below.
`
`1 Exhibits (“Ex. #”) are attached to the Declaration of William P. Nelson, filed
`concurrently herewith.
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`IRAZOQUI DECLARATION
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`15.
`I understand that claim construction begins with the language of the claim
`and asks how a person of ordinary skill in the art, reading in light of the specification,
`would have understood the claim terms at the time of invention.
`16.
`I understand that various sources are available that may help show what a
`claim term should mean. These sources include the text of the claims themselves, the
`patent’s specification, the prosecution history of the patent, and the prior art cited in a
`patent or in the prosecution history. Together, I understand that these sources are called
`“intrinsic” evidence. I also understand that other sources for example concerning
`relevant scientific principles, dictionaries or technical dictionaries, and other
`information concerning the state of the art is called “extrinsic” evidence. I understand
`that extrinsic evidence may not be used to contradict the claim language.
`17.
`I understand that claim terms should be given their ordinary meaning
`unless the patentee has clearly set forth a different meaning in the specification or the
`prosecution history, e.g., by acting as his or her own lexicographer.
`18.
`I understand that the context in which a claim term is used can be highly
`instructive. Other claims of the patent in question, both asserted and not asserted, can
`also be valuable sources as to the meaning of a claim term. Because claim terms are
`normally used consistently throughout the patent, the usage of a term in one claim can
`often illuminate the meaning of the same term in other claims. Differences among
`claims can also be a useful guide in understanding the meaning of particular claim
`terms.
`19.
`I understand that a person of ordinary skill in the art is deemed to read a
`claim term not only in the context of the particular claim in which the disputed term
`appears, but also in the context of the entire patent, including the specification. The
`specification is the primary basis for construing the claims and is considered the single
`best guide to the meaning of a disputed term. For this reason, the words of the claim
`must be interpreted in view of the specification. The interpretation of a term can only
`be determined and confirmed with a full understanding of what the inventors actually
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`invented and intended to cover within the claim.
`20. A claim term should not be interpreted to exclude embodiments disclosed
`in the specification absent probative evidence on the contrary. I further understand
`that, in general, the claimed invention is not limited to a preferred embodiment, even if
`the specification does not describe any other embodiment.
`21.
`I understand that claim terms must inform, with reasonable certainty,
`those skilled in the art about the scope of the invention, when read in light of the patent
`and the prosecution history. I understand that if they fail to do so, such claim terms are
`indefinite.
`22.
`In addition to consulting the specification, one should also consider the
`patent’s prosecution history, if it is available. The prosecution history consists of the
`complete record of the proceedings before the Patent Office and includes cited prior
`art. The prosecution history can inform the meaning of the claim language by
`demonstrating how the inventor understood the invention. I understand that the prior
`art cited in a patent or the prosecution history of the patent also constitutes intrinsic
`evidence.
`23.
`I have been asked to offer my opinion regarding the level of ordinary skill
`in the art at the time of the invention or the effective filing date. I have considered the
`types of problems encountered in the art, the prior solutions to those problems found in
`prior art references, the rapidity with which innovations are made, the sophistication of
`the technology, the level of education of active workers in the field and my own
`experience working with those of skill in the art at the time of inventions.
`E.
`Level of Ordinary Skill in the Art
`1.
`314 and 756 Patents
`24.
`In my opinion, a person of ordinary skill in the art (“POSITA”) in the
`field of the 314 and 756 Patents at the time of the alleged invention, would have had
`(1) at least a bachelor’s degree in biomedical engineering, electrical engineering,
`mechanical engineering, or equivalent coursework, and (2) at least two years of
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`experience researching or developing active, implantable medical devices.
`25.
`I am well qualified to determine the level of ordinary skill in the art. I am
`very familiar with the technologies of the 314 and 756 Patents as of their earliest
`possible priority date (August 2001) and times thereafter. By that time, I had already
`spent two years working on my Ph.D. thesis, concerning a transcutaneous, inductively-
`powered neural recording system.
`26.
`I understand that Medtronic has contended a different level of ordinary
`skill in the art for the 314 and 756 Patents. Specifically, I understand that Medtronic
`contends that a POSITA at the time of the invention:
`would have been a physician with at least two years of experience in
`sacral neuromodulation, or an implantable medical lead designer with at
`least three years of experience designing and researching leads for use in
`sacral neuromodulation, and working in close collaboration with a
`physician having two years of experience in sacral neuromodulation.
`More education can substitute for practical experience and vice versa.
`
`
`Medtronic’s 3/21/22 Response to Axonics’ Interrogatory No. 9 at 10.
`27.
`I disagree with Medtronic’s proposed level of ordinary skill in the art. It is
`not clear to me why the requirements for a practicing physician would be two years of
`experience in sacral neuromodulation, but an implantable medical lead designer would
`need at least three years of experience in the same field. Nor is it clear to me why a
`physician with experience in sacral neuromodulation would be deemed a person of
`ordinary skill in the art with respect to the design of implantable medical devices.
`28. More fundamentally, I disagree with the proposed requirement of years of
`specific experience in sacral neuromodulation, for several reasons. First, none of the
`claims of the 314 and 756 Patents appear to be limited to sacral neuromodulation; they
`do not recite sacral neuromodulation, or the sacral nerves.
`29. Next, the specification similarly does not limit its description of the
`purported invention to sacral neuromodulation. For example, the “summary of the
`invention” section of the 314 and 756 Patents state that the patents address problems
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`“associated with implanting and maintaining electrical leads in body tissue,
`particularly muscle tissue”:
`The present invention recognizes and provides a solution to the problems
`associated with implanting and maintaining electrical leads in body tissue,
`particularly muscle tissue to maintain one or more lead electrode in
`relation to a particular body site, through use of minimally invasive
`implantation techniques.
`
`
`
`314 Patent at 5:48-53.
`30.
`In addition, the specification explicitly recites uses for its disclosed lead
`outside of sacral neuromodulation, including for use as “an intramuscular lead where
`the tines can engage against muscle and assist in preventing dislodgement of the distal
`electrode(s),” such as in the stomach or in connection with the anal sphincter muscle.
`314 Patent at 13:32-39.
`31. Finally, the specification itself confirms that a POSITA would have more
`general experience with implantable medical leads than a specific focus on sacral
`neuromodulation. The 314 and 756 Patent’s “Description of Related Art” (314 Patent
`at 1:45) discusses implantable medical leads not only in connection with sacral nerves
`(id. at 1:46-4:24), but also in connection with many other types of body tissue, stating
`that the “prior art discloses a number of configurations of implantable medical
`electrical leads other than neurostimulation leads that employ fixation mechanisms to
`maintain a stimulation electrode in relation to a body organ or tissue.” 314 Patent at
`4:24-27. This includes implantable cardiac pacing leads (id. at 4:28-5:8), sensing leads
`for cardiac monitors (id. at 5:9-33), and “certain spinal cord stimulation leads” which
`“have been proposed employing tines and/or vanes as stand-offs to urge the
`stimulation electrode in the epidural space toward the spinal cord . . . and to stabilize
`the stimulation electrode in the epidural space.” 314 Patent at 4:42-48. This confirms
`that, rather than needing to be a sacral neuromodulation specialist, a POSITA would be
`aware of, and draw from, many different implementations of implantable medical
`devices.
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`32. Based on my more than 20 years of experience, I believe that I am an
`expert in the art of implantable medical devices. While I do not fully agree with
`Medtronic’s definition of a person of ordinary skill, my opinions, discussed below,
`remain the same even under Medtronic’s definition of ordinary skill. By 2002, I
`qualified as a person of ordinary skill under both my and Medtronic’s definitions of
`such a person. In my opinion, an ordinarily skilled artisan under either Axonics’
`proposal or Medtronic’s would come to the same conclusion regarding the meaning of
`the disputed terms.
`2.
`324 Patent
`33.
`I understand that in the inter partes review proceedings for these patents,
`Medtronic contended that a POSITA at the time of the invention:
`would have had at least a bachelor’s degree in a relevant field (e.g.,
`electrical, mechanical, or biomedical engineering) with at least two years
`of experience with the design of components (e.g., circuitry) for
`implantable medical devices and associated external devices (e.g., a
`charging unit). (Ex. 2022, 14.) More education can substitute for practical
`experience and vice versa.
`Ex. 32, IPR2020-00713 (112 Patent), Paper 22, at 5-6.
`34.
`I agree with Medtronic’s proposed level of ordinary skill in the art for the
`324 Patent. I am well qualified to determine the level of ordinary skill in the art. Based
`on my more than 20 years of experience, I believe that I am an expert in the art of
`implantable medical devices. I am very familiar with the technologies of the 324 and
`112 Patents as of their earliest possible priority date (October 2003) and times
`thereafter. By that time, I had completed my Ph.D. thesis, concerning a transcutaneous,
`inductively-powered neural recording system. By 2003, I qualified as a person of
`ordinary skill under Medtronic’s proposed level of ordinary skill in the art.
`3.
`148 and 758 Patents
`35.
`I understand that in the inter partes review for these patents, Medtronic
`contended that a POSITA at the time of the invention:
`would have had at least a bachelor’s degree in a relevant field (e.g.,
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`electrical, mechanical, or biomedical engineering) with at least two years
`of experience with the design of components (e.g., circuitry) for
`implantable medical devices and associated external devices (e.g., a
`charging unit). (Ex. 2002 at ¶¶ 21-22.) More education can substitute for
`practical experience and vice versa.
`
`
`Ex. 29, IPR2020-00678 (069 Patent), Paper 15, at 3-4.
`36.
`I agree with Medtronic’s proposed level of ordinary skill in the art for the
`148 and 758 Patents. I am well qualified to determine the level of ordinary skill in the
`art. Based on my more than 20 years of experience, I believe that I am an expert in the
`art of implantable medical devices. I am very familiar with the technologies of the 148,
`758 and 069 Patents as of their earliest possible priority date (April 2005) and times
`thereafter. By that time, I had completed my Ph.D. thesis, concerning a transcutaneous,
`inductively-powered neural recording system. By 2005, I qualified as a person of
`ordinary skill under Medtronic’s proposed level of ordinary skill in the art.
`II. OVERVIEW OF PATENTS-IN-SUIT
`37. The 314 and 756 Patents are directed to an implantable medical electrical
`lead that purports to address “problems associated with implanting and maintaining
`electrical leads in body tissue, particularly muscle tissue to maintain one or more lead
`electrode in relation to a particular body site, through use of minimally invasive
`implantation techniques.” 314 Patent at 5:48-532. For sacral nerve stimulation, the
`preferred embodiments of the 314 and 756 Patent address a purported “need in the art
`for a permanently implantable electrical sacral nerve stimulation lead that is capable of
`being passed percutaneously over a guide wire, and/or through the lumen of an
`introducer from the patient’s skin to locate stimulation electrodes in casual contact
`with a sacral nerve, that provides acute fixation with muscle and tissue layers posterior
`
`
`2 The 314 and 756 Patents are both continuations of U.S. Patent Application No.
`10/004,732; as such, they share the same specification. For purposes of simplicity, I
`will cite to the 314 Patent specification.
`
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`to the sacrum, and that can be bent to extend subcutaneously to the neurostimulator
`IPG without disturbing the fixation so that the stimulation electrodes are less likely to
`be dislodged during the acute recovery phase and the chronic implantation period.” Id.
`at 5:34-44.
`38. The specification of
`the 314 and 756 Patents describes several
`embodiments of an implantable medical lead comprising a lead body 15 and P number
`of electrodes on the distal end (i.e., toward the tip) of the lead body, “where P=one or
`more” electrodes arranged in an array spaced apart from one another. Id., 6:26-30,
`9:25-30; see also id. at 12:51-53 (P=one); Fig. 1. Each electrode (25, 30, 35, 40) is
`electrically coupled to a wire lead conductor within the lead body and the conductor is
`coupled to connector elements (65, 70, 75, 80) at the proximal end (i.e., the back of the
`lead). Id. at 9:41-49; Fig. 1. Those connector elements are adapted to be coupled to an
`IPG, including Medtronic InterStim Neurostimulator Model 3023. Id., 9:62-67.
`39.
`In the disclosed embodiments, the electrodes are affixed through “[t]he
`fixation mechanism compris[ing] a plurality M of tine elements [125, 130, 135, 140]
`arrayed in a tine element array [120]. . . . Each tine element comprises at least N
`flexible, pliant, [sic] tines [145, 150, 155, 160], each tine having a tine width and
`thickness and extending through a tine length from an attached tine end [165] to a free
`tine end [170].” Id., 5:65-6:12; 6:42-47; Id., 10:12-32; 10:42-52; Figs. 1, 3.
`40. The 314 and 756 Patents disclose that their lead is introduced through an
`introducer such that the tines are adapted to be folded inward against the lead body
`when constrained in the introducer lumen. Id., 7:1-35; 10:59-64; 11:22-28; Figs. 5-8.
`The lead is advanced to the stimulation site and the electrode array of the lead is
`“advanced distally out of the introducer lumen.” Id., 7:36-43, 11:28-36. Then, the
`introducer is retracted proximally (and withdrawn completely) and the tines are
`successively released from the introducer lumen to bear against the tissue to inhibit
`proximal retraction. Id., 7:43-55; 11:9-15; 12:6-22.
`41. The 324 Patent describes mechanisms for transferring energy from an
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`44. The temperature sensor 87 and control circuitry incorporated into the
`external charging device 48 are not shown in the above figure. The 324 Patent
`describes the temperature sensor and its function in the following passage:
`In a preferred embodiment, external charging device 48 incorporates
`temperature sensor 87 in external antenna 52 and control circuitry in
`charging unit 50 which can ensure that external antenna 52 does not
`exceed acceptable temperatures, generally a maximum of thirty-eight
`degrees Centigrade (38º C.). Temperature sensor 87 in external antenna
`52 can be used to determine the temperature of external antenna 52.
`Temperature sensor 87 can be positioned in close proximity to thermally
`conductive material 62 in order to obtain reasonably accurate information
`on the temperature of the external surface of external antenna 52
`contacting patient 18. Preferably, temperature sensor 87 is affixed to
`thermally conductive material 62 with a thermally conductive adhesive.
`Thermally conductive material 62 smoothes out any temperatures
`differences which otherwise might occur on the surface of external
`antenna 52 contacting patient 18. Positioning temperature sensor 87 in the
`proximity or touching thermally conductive material 62 enables an
`accurate measurement of the contact temperature.
`
`Id. at 20:4-22.
`45. The 324 patent also describes control circuitry that uses the output from
`the temperature sensor to limit the energy transfer in order to limit the temperature to
`which the patient is exposed. Id. at 20:23-26.
`46. The 148 and 758 Patents describe energy transfer systems for implantable
`medical devices. FIG. 3 of the 148 Patent is a block diagram of the system showing an
`implantable medical device 16 positioned under a cutaneous boundary 38 and an
`external charging device 48.
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`47. As shown in Figure 3, the implantable medical device 16 is paired with an
`external charging device 48 that charges an internal battery 24 via inductance between
`the external primary coil 54 and the internal secondary coil 34. 148 Patent at 8:21-28.
`The charging is controlled by the external charging device 48, which includes a
`charging unit 50 that causes the external primary coil 54 to induce current in internal
`secondary coil 34 when external primary coil 54 is placed in the proximity of internal
`secondary coil 34. Id.
`48. The 148 and 758 Patents claim aspects of the alignment and charging
`process, such as the external charging device varying its power output based on
`multiple inputs, including a value associated with the current flowing through the
`internal battery.
`III. CLAIM CONSTRUCTION
`A. Disputed Term: “plurality of tine elements” (756 Patent claim 14; 314
`Patent claims 1, 7, 11, 18, 20, 21)
`Medtronic’s Proposed Construction
`Axonics’ Proposed Construction
`Two or more parts or portions that include
`Two or more structures to which one or
`tines along the length of the lead body and
`more tines are attached
`which may form a single structure
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`
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`49.
`I understand that Medtronic and Axonics have proposed the constructions
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`in the preceding table for the term “plurality of tine elements” in Claim 14 of the 756
`Patent and Claims 1, 7, 11, 18, 20, and 21 of the 314 Patent. I have considered
`Medtronic’s and Axonics’ proposed constructions for this term. It is my opinion that a
`person of ordinary skill in the art, reading the claims, specifications, and file histories
`of the 314 and 756 Patents, would understand the term “plurality of tine elements”
`recited in the claims to mean “two or more structures to which one or more tines are
`attached” as Axonics proposes.
`50. Here, I provide my opinions concerning how a POSITA would understand
`certain statements made by the applicants during prosecution of this family of patents.
`My opinion is that these statements confirm that a “plurality of tine elements” excludes
`tine elements formed as a single structure. During prosecution of U.S. App. No.
`11/589,407, a “parent” patent application to the 314 and 756 Patents that issued as U.S.
`Patent No. 8,000,805, Medtronic sought allowance of original claim 1, which recited a
`single “tine element”:
`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.
`
`
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`Claim 14 similarly recited “a tine element.” Ex. 20 at MDT-00136385 (10/30/2006
`submitted claims at 20).
`51. The Examiner rejected claims 1 and 14 in view of multiple pieces of prior
`art, including U.S. Patent No. 5,902,330 (“Ollivier”), and found that “Ollivier discloses
`tine elements, 26.” Ex. 20 at MDT-00136321-323 (6/1/2009 Office Action at 6-8.).
`52. Figure 1 of Ollivier shows the distal end, or tip, of a medical lead.
`Attached to the “cylindrical body” 10 of the lead are two tines, each numbered 26.
`
`IRAZOQUI D