UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`NEVRO CORP.
`Petitioner
`
`v.
`
`BOSTON SCIENTIFIC NEUROMODULATION CORP.
`Patent Owner
`
`_____________________
`
`Case IPR2018-00143
`U.S. Patent 7,891,085
`_____________________
`
`DECLARATION OF MICHAEL PLISHKA
`
`
`
`
`
`
`
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`
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`
`
`Nevro Corp.
`Ex. 1003
`U.S. Patent No. 7,891,085
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`TABLE OF CONTENTS
`
`I. 
`Introduction ...................................................................................................... 1 
`Summary of my opinions ................................................................................ 1 
`II. 
`III.  Qualifications ................................................................................................... 2 
`IV.  Materials considered ........................................................................................ 4 
`V. 
`Relevant legal standards .................................................................................. 5 
`A. 
`Level of ordinary skill ........................................................................... 6 
`B. 
`Claim construction ................................................................................ 7 
`C. 
`Obviousness ........................................................................................... 8 
`VI.  The ’085 patent ................................................................................................ 9 
`A.  Overview of implantable stimulation leads ......................................... 10 
`B. 
`Overview of the claimed invention ..................................................... 13 
`1. 
`The claims define a stimulation lead having certain features. .. 14 
`2. 
`The claims are method claims directed to a method for
`manufacturing the described stimulation lead. ......................... 20 
`VII.  Overview of the prior art. .............................................................................. 27 
`A. 
`Stolz overview ..................................................................................... 27 
`B. 
`Ormsby overview ................................................................................ 35 
`C. 
`Verness overview ................................................................................ 36 
`D. 
`Black overview .................................................................................... 38 
`E.  Wessman overview .............................................................................. 40 
`F. 
`The Modern Plastics Encyclopedia overview ..................................... 42 
`G. 
`Saab overview ..................................................................................... 42 
`VIII.  The combination of Stolz, Ormsby, Black, and the knowledge of a POSA
`renders obvious claims 1-3, 6-12, and 14-17 of the ’085 patent. .................. 43 
`A. 
`Independent claim 1 ............................................................................ 45 
`1. 
`“A method of manufacturing a stimulation lead having a
`proximal end and a distal end, comprising:” ............................ 45 
`“providing a plurality of conductive contacts located at an
`end of a lead body of the stimulation lead;” ............................. 46 
`
`2. 
`
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`B. 
`
`C. 
`
`D. 
`
`E. 
`
`F. 
`
`6. 
`
`7. 
`
`8. 
`
`3. 
`
`4. 
`
`5. 
`
`“disposing a plurality of conductor wires in a plurality of
`conductor lumens formed in the lead body;” ............................ 47 
`“connecting at least one of the plurality of conductor wires
`to each of the conductive contacts;” ......................................... 49 
`“placing spacers between pairs of adjacent conductive
`contacts,” ................................................................................... 52 
`“wherein portions of the conductor lumens are located
`beneath the plurality of conductive contacts and the
`spacers;” .................................................................................... 52 
`“inserting monofilament into at least one portion of at least
`one of the conductor lumens of the lead body that is not
`occupied by the conductor wires;” ............................................ 54 
`“reflowing at least one of the spacers or monofilament into
`at least one portion of at least one of the conductor lumens
`not occupied by the conductive wires by heating the spacers
`and monofilament to a temperature to cause thermal flow or
`melting of at least one of the spacers or monofilament.” ......... 63 
`Claim 2 ................................................................................................ 68 
`1. 
`“The method of claim 1,” .......................................................... 68 
`2. 
`“wherein either the spacers or monofilament is
`polyurethane.” ........................................................................... 68 
`Claim 3 ................................................................................................ 70 
`1. 
`“The method of claim 2,” .......................................................... 70 
`2. 
`“wherein the monofilament is a thermoplastic material.” ........ 70 
`Claim 6 ................................................................................................ 71 
`1. 
`“The method of claim 1,” .......................................................... 71 
`2. 
`“wherein the spacers are oversized in diameter, relative to a
`predetermined final diameter of the lead.” ............................... 71 
`Claim 7 ................................................................................................ 72 
`1. 
`“The method of claim 1,” .......................................................... 72 
`2. 
`“wherein conductive contacts are in the form of rings.” .......... 72 
`Claim 8 ................................................................................................ 73 
`1. 
`“The method of claim 1,” .......................................................... 73 
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`2. 
`
`G. 
`
`H. 
`
`I. 
`
`J. 
`
`“wherein the conductive contacts are electrode contacts on
`the lead.” ................................................................................... 73 
`Claim 9 ................................................................................................ 74 
`1. 
`“The method of claim 1,” .......................................................... 74 
`2. 
`“wherein the conductive contacts are connector contacts on
`the proximal end of the lead.” ................................................... 74 
`Claim 10 .............................................................................................. 75 
`1. 
`“The method of claim 1,” .......................................................... 75 
`2. 
`“wherein the step of connecting a conductor wire to each of
`the electrode contacts is accomplished by welding each
`conductor wire to each respective contact.” ............................. 75 
`Claim 11 .............................................................................................. 76 
`1. 
`“The method of claim 1” ........................................................... 76 
`2. 
`“wherein the monofilament is a different material than the
`spacers.” .................................................................................... 77 
`Claim 12 .............................................................................................. 77 
`1. 
`“The method of claim 1,” .......................................................... 77 
`2. 
`“wherein the monofilament is the same material as the
`spacers.” .................................................................................... 78 
`Claim 14 .............................................................................................. 78 
`1. 
`“The method of claim 1,” .......................................................... 78 
`2. 
`“wherein the plurality of electrically conductive contacts are
`located on the proximal end of the stimulation lead.” .............. 78 
`Claim 15 .............................................................................................. 79 
`1. 
`“The method of claim 1,” .......................................................... 79 
`2. 
`“wherein the plurality of electrically conductive contacts are
`located on the distal end of the stimulation lead.” .................... 79 
`M.  Claim 16 .............................................................................................. 79 
`1. 
`“The method of claim 1,” .......................................................... 79 
`2. 
`“wherein the plurality of electrically conductive contacts and
`the spacers form a substantially cylindrical body and
`wherein the conductor lumens are defined within the
`substantially cylindrical body.” ................................................ 80 
`
`K. 
`
`L. 
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`N. 
`
`Claim 17 .............................................................................................. 81 
`1. 
`“The method of claim 1,” .......................................................... 81 
`2. 
`“wherein the monofilament is disposed in an orientation
`parallel to the conductor wires.” ............................................... 81 
`IX.  The combination of Stolz, Ormsby, Black, and the knowledge of a
`POSA, further in view of the Modern Plastics Encyclopedia, renders
`obvious claims 4, 5, and 13 of the ’085 patent. ............................................. 82 
`A. 
`Claim 4 ................................................................................................ 84 
`1. 
`“The method of claim 3,” .......................................................... 84 
`2. 
`“wherein the heat applied is between about 140 to 250
`degrees Celsius.” ....................................................................... 85 
`Claim 5 ................................................................................................ 86 
`1. 
`“The method of claim 4,” .......................................................... 86 
`2. 
`“wherein the heat is applied for between about 15 to 120
`seconds.” ................................................................................... 86 
`Claim 13 .............................................................................................. 89 
`1. 
`“The method of claim 5,” .......................................................... 89 
`2. 
`“wherein the heat applied is about 160 degrees Celsius for
`about 40 seconds.” .................................................................... 89 
`The combination of Stolz, Ormsby, Black, the knowledge of a POSA,
`further in view of Wessman, render obvious claim 18 of the ’085 patent. ... 89 
`A. 
`Claim 18 .............................................................................................. 90 
`1. 
`“The method of claim 1,” .......................................................... 90 
`2. 
`“placing a heat shrink tubing around the spacers, conductive
`contacts, and monofilament and removing the heat shrink
`tubing after reflowing at least one of the spacers or
`monofilament.” ......................................................................... 90 
`XI.  The combination of Stolz, Ormsby, Black, the knowledge of a POSA,
`and Wessman, further in view of Saab, renders obvious claim 19 of the
`’085 patent. .................................................................................................... 92 
`A. 
`Claim 19 .............................................................................................. 92 
`1. 
`“The method of claim 18,” ........................................................ 92 
`
`B. 
`
`C. 
`
`X. 
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`2. 
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`“wherein the heat shrink tubing is made from a material
`selected from the group consisting of PTFE or polyester heat
`shrink material.” ........................................................................ 92 
`XII.  Other evidence relevant to obviousness ........................................................ 94 
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`I, Michael Plishka, declare as follows:
`
`I.
`
`Introduction
`1.
`
`I have been asked by Nevro Corp. (“Nevro”) to provide my opinions
`
`in the above-captioned Inter Partes Review proceeding involving U.S. Patent No.
`
`7,891,085 (“the ’085 patent,” Ex. 1001), which is titled “Electrode Array
`
`Assembly and Method of Making Same.”
`
`2.
`
`I am being compensated on an hourly basis for the time I spend in
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`connection with this proceeding. My compensation is not dependent in any way on
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`the substance of my opinions or in the outcome of this proceeding.
`
`II.
`
`Summary of my opinions
`3.
`
`To assist and orient the reader in reviewing this declaration, I have
`
`provided a summary of my main opinions below. A person of ordinary skill in the
`
`art at the time of the alleged invention (“ a POSA”) would have found the subject
`
`matter of the following claims obvious in view of the prior art:
`
`4.
`
`Claims 1-3, 6-12, and 14-17 would have been obvious over U.S.
`
`Patent App. Pub. No. 2003/0199950 to Stolz et al. (“Stolz,” Ex. 1005) in view of
`
`Int’l. Patent App. Pub. No. WO 00/35349 to Ormsby et al. (“Ormsby,” Ex. 1006),
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`U.S. Patent No. 6,216,045 to Black et al. (“Black,” Ex. 1008), and the knowledge
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`of a POSA;
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`5.
`
`Claims 4, 5, and 13 would have been obvious over Stolz in view of
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`Ormsby, Black, and the knowledge of a POSA, and in further view of the 1986-87
`
`edition of the Modern Plastics Encyclopedia, published by McGraw Hill (“the
`
`Modern Plastics Encyclopedia,” Ex. 1010);
`
`6.
`
`Claim 18 would have been obvious over Stolz in view of Ormsby,
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`Black, and the knowledge of a POSA, and in further view of U.S. Patent App. Pub.
`
`No. 2002/0143377 to Wessman et al. (“Wessman,” Ex. 1009); and
`
`7.
`
`Claim 19 would have been obvious over Stolz in view of Ormsby,
`
`Black, the knowledge of a POSA, and Wessman, and in further view of Mark
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`Saab, “Using Thin-Wall Heat-Shrink Tubing in Medical Device Manufacturing,”
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`Medical Device & Diagnostic Industry Magazine (April 1999). (“Saab,” Ex. 1011).
`
`III. Qualifications
`8.
`A copy of my curriculum vitae is provided as Ex. 1004.
`
`9.
`
`During the course of my career, I have been exposed to multiple
`
`experiences that have equipped me to provide expert opinions on this case.
`
`10.
`
`I hold a Bachelor of Science in Mechanical Engineering from the
`
`University of Illinois at Chicago, and a Master of Arts from Loyola University of
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`Chicago.
`
`11.
`
`I am an author of several publications, including publications related
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`to electrical stimulation technologies, and am a named inventor on several U.S. and
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`foreign utility and design patents, along with several currently pending patent
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`applications.
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`12.
`
`I also have deep design and engineering experience, working with
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`clinicians to develop, test, prototype, and design numerous medical devices.
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`13.
`
`In particular, at the Hines VA/Loyola position listed on my
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`curriculum vitae, I designed and developed surface and implantable electrodes
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`made from silicone and conductive wires and mesh. These were successfully used
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`for monitoring and stimulating people and animals in medical studies. These
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`electrodes were used to both monitor and stimulate various nerves (both on the
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`surface of the skin, and implanted) that control the bladder and colon. These
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`electrodes helped spinal cord injured patients control their bodily functions such as
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`defecation and micturition.
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`14. Following this, at Manan Medical Products, I designed and developed
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`medical devices (e.g., interventional catheters and needles) and their
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`manufacturing processes. These devices, and their manufacturing techniques,
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`utilized various types of thermoplastic polyurethanes, and techniques to bond
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`components together. Specifically, I developed manufacturing processes that
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`utilized heat to join disparate pieces of polyurethane together. I also gained
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`experience in ultrasonic welding, solvent bonding, plastic film welding,
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`thermoplastic tray forming and injection molding – processes that relied upon the
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`melting and reflowing of polymers. I also experimented with heat shrink tubing as
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`a means for holding and bonding plastics.
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`15. At Manan, I also designed multi-lumen tubes to be used in medical
`
`devices, and built prototype devices using the heat joining processes described
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`above. This included designing manufacturing processes and fixtures, and selecting
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`particular materials for components to be joined, e.g., based on the properties of
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`different types of materials.
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`16. Following my tenure at Manan, I utilized and built upon this
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`knowledge at Allegiance Healthcare, designing similar processes, including tipping
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`catheters and backfilling lumens.
`
`IV. Materials considered
`17.
`In formulating my opinions, I have relied upon my training,
`
`knowledge, and experience that are relevant to the ’085 patent. Furthermore, I have
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`specifically considered the following documents, in addition to any other
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`documents cited in this declaration:
`
` The ’085 patent, Ex. 1001;
`
` Stolz, Ex. 1005;
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` Ormsby, Ex. 1006;
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` Verness, Ex. 1007;
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` Black, Ex. 1008;
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` Wessman, Ex. 1009;
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` Modern Plastics Encyclopedia, Ex. 1010;
`
` Saab, Ex. 1011;
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` Huepenbecker, Ex. 1012;
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` Mahurkar, Ex. 1013;
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` Whitfill, Ex. 1014;
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` Cartmell, Ex. 1015; and
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` Schallhorn et al., Ex. 1016.
`
`V. Relevant legal standards
`18.
`In forming my opinions, I have also relied upon various legal
`
`principles (as explained to me by Nevro’s counsel). My understanding of these
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`principles is summarized below.
`
`19.
`
`I understand that a patent claim defines the scope of an alleged
`
`invention. I further understand that a claimed invention must be new, useful, and
`
`non-obvious over the prior art for it to be patentable. I understand that in this
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`proceeding Nevro has the burden of proving that the challenged claims would have
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`been unpatentable over the prior art by a preponderance of the evidence. I
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`understand that “a preponderance of the evidence” is evidence sufficient to show
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`that a fact is more likely true than it is not.
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`20.
`
`In determining the patentability of a claim, I understand that the first
`
`step is to understand the claim from the perspective of a POSA to determine its
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`meaning and scope. With that understanding, I will consider the claims at issue
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`here against the prior art from the perspective of a POSA, as further summarized
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`below.
`
`A. Level of ordinary skill
`21.
`I understand that a claim must be analyzed from the perspective of a
`
`POSA at the time the claimed invention was allegedly invented by the patentee.
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`Nevro’s counsel has informed me to consider the time period shortly before
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`January 11, 2005, as the potential date of invention of the claims of the ’085 patent
`
`because that is the earliest filing date on the face of the ’085 patent.
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`22.
`
`In ascertaining the appropriate level of ordinary skill in the art of a
`
`patent, I understand that several factors should be considered including (1) the
`
`types of problems encountered in the art; (2) the prior art solutions to those
`
`problems; (3) the rapidity with which innovations are made; (4) the sophistication
`
`of the technology; and (5) the educational level of active workers in the field of the
`
`patent.
`
`23.
`
`I further understand that a POSA is a person who is presumed to be
`
`aware of the pertinent art as of the time of the alleged invention, thinks along the
`
`line of conventional wisdom in the art, and is a person of ordinary creativity.
`
`Accordingly, a POSA of the ’085 patent would have had general knowledge of
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`implantable medical devices and various related technologies as of January 11,
`
`2005.
`
`24. Based on my experience and my understanding of the legal principles
`
`summarized here, I believe that, in the context of the ’085 patent, a POSA shortly
`
`before January 11, 2005 would have had (1) at least a bachelor’s degree in a
`
`relevant life sciences field, mechanical engineering, electrical engineering,
`
`biomedical engineering, or equivalent coursework, and (2) at least one year of
`
`experience researching or developing implantable medical devices, or methods of
`
`their manufacture. Well before January 11, 2005, my level of skill in the art was at
`
`least that of a POSA, as discussed above.
`
`B. Claim construction
`25.
`I have been informed by Nevro’s counsel that, in this proceeding, the
`
`claims of an unexpired patent —like the ’085 patent— are given their broadest
`
`reasonable interpretation as understood by a POSA in light of the patent
`
`specification. Accordingly, in forming my opinions, I have applied the broadest
`
`reasonable interpretation of the claims of the ’085 patent as I perceive a POSA
`
`would have understood them shortly before January 11, 2005, and in view of the
`
`’085 patent specification.
`
`26.
`
`I note that the patentee did not provide a glossary of terms. And after
`
`reviewing the specification, the patentee does not appear to have given any of the
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`claim terms a special meaning that differs from the plain and ordinary meaning a
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`POSA would ascribe to them. The only term that the patentee appears to have
`
`expressly construed in the ’085 patent specification is the term “lead.” And there,
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`the term is broadly construed as “an elongate device having any conductor or
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`conductors, covered with an insulated sheath and having at least one electrode
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`contact attached to the elongate device, usually at the distal portion of the elongate
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`device.” (Ex. 1001 at 1:32-35.) This construction is consistent with the broadest
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`reasonable interpretation of the claims of the ’085 patent that I have applied in
`
`forming my opinions. At this time, I do not believe that any other terms in the
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`challenged claims require an express construction.
`
`27.
`
`I have been informed, however, that claim construction is ultimately a
`
`question of law. Accordingly, I understand that a tribunal may choose to expressly
`
`construe certain terms to provide clarity to the proceeding should any dispute arise
`
`between the parties over how a term should be construed. If the tribunal chooses to
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`construe any term, then I reserve my right to review and potentially modify any
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`opinions below in view of such constructions.
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`C. Obviousness
`28.
`I have been informed by Nevro’s counsel that a patent claim is
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`unpatentable if the differences between the claimed invention and the prior art are
`
`such that the claimed invention as a whole would have been obvious to a POSA at
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`the time of the alleged invention. Thus, in assessing whether a claim is obvious, I
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`understand that I am to consider (1) the scope and content of the prior art; (2) the
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`level of ordinary skill in the field of the invention; (3) the differences between the
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`claimed invention and the prior art; and (4) any objective evidence of non-
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`obviousness.
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`29. Nevro’s counsel has explained to me a number of exemplary
`
`rationales under which a POSA could find a claim to have been obvious. To list
`
`some examples, I understand that if a POSA could have arrived at a claimed
`
`invention by (a) combining prior art elements according to known methods to yield
`
`predictable results; (b) applying a solution from a finite number of identified,
`
`predictable solutions, with a reasonable expectation of success; (c) substituting one
`
`known element for another to obtain predictable results; or (d) using a known
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`technique to improve similar devices (methods, or products) in the same way, the
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`claimed invention would likely have been obvious to a POSA. I have taken at least
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`these rationales under consideration in analyzing the claims at issue here.
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`VI. The ’085 patent
`30. The ’085 patent is titled “Electrode Array Assembly and Method of
`
`Making Same,” and is directed generally to “implantable leads for providing
`
`electrical stimulation and, more particularly, relates to leads having multiple
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`electrode contacts and methods of making such leads.” (Ex. 1001 at 1:11–14.)
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`A. Overview of implantable stimulation leads
`31.
`Implantable medical devices, including implantable stimulation leads,
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`were well known long before the alleged invention of the ’085 patent. (Id. at 1:18–
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`62.) For example, the ’085 patent itself identifies several exemplary implantable
`
`stimulation leads, such as cochlear stimulator systems and spinal cord stimulation
`
`systems. (Id. at 1:18–25.) The ’085 patent also references numerous prior art
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`patents that describe additional stimulation leads, such as deep brain stimulation,
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`cardiac stimulation, and peripheral nerve stimulation leads. (Id. at 1:18–62; 7:64–8:
`
`4.)
`
`32. Most spinal cord stimulation systems have two implantable
`
`components: “an implantable pulse generator (IPG) and at least one lead connected
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`to one output of the IPG.” (Id. at 1:26–31.) The IPG is generally a multi-channel
`
`device that delivers electrical current through the electrode contacts of the lead.
`
`(Id.)
`
`33. Below is an annotated depiction of an exemplary prior art stimulation
`
`system implanted within a patient, as shown in the prior-art Stolz reference:
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`Implanted
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`Lead with multiple
`
`(Ex. 1005, Stolz at FIG. 1, annotated.)
`
`34. The ’085 patent depicts a similar implantable system with a
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`
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`microstimulator 12 and a lead 18 having multiple electrodes:
`
`
`(Ex. 1001 at FIGS. 1, 2; 4:6–16.)
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`35. Figures 1 and 2 of the ’085 patent show a transverse, mid-sagittal
`
`view of a spinal cord and a generalized, implantable, spinal cord stimulation
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`system. (Ex. 1001 at FIGS. 1, 2; 4:6–16.) In such a spinal cord stimulator (SCS)
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`system, the lead 16 and the electrode array 18 are implanted in the epidural space
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`20 of a patient in close proximity to the spinal cord 19. (Id.) Because of the lack of
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`space where the electrode lead 16 exits the spinal column (the lead exit point 15),
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`the IPG 12 may be implanted in the abdomen or above the buttocks. (Id.) A lead
`
`extension 14 facilitates locating the IPG 12 away from the lead exit point 15. (Id.)
`
`36. The ’085 patent describes two types of leads that may be used with
`
`the IPG—paddle leads and percutaneous leads. Paddle leads have a multiplicity of
`
`electrode contacts spread out over a flat, paddle-like surface that is attached to one
`
`end of the lead. (Id. at 1:42–45.) Percutaneous leads have multiple electrode
`
`contacts along the distal portion of an elongate lead. (Id. at 1:52–54.) The ’085
`
`patent generally discusses the tradeoffs between the two types of leads. (Id. at
`
`1:42–62.)
`
`37. The ’085 patent also generally discusses a method of making a multi-
`
`contact percutaneous lead. The ’085 patent notes the obvious goals of nearly every
`
`manufacturing process, including processes for manufacturing implantable leads:
`
`“it is desirable to make the lead efficiently, with the fewest number of process
`
`steps, maximize the manufacturing yield, and hence reduce the cost of goods of
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`building the leads.” (Id. at 1:63–67.) At the same time, percutaneous stimulation
`
`leads must be reliable, durable, and safe because they are designed to be implanted
`
`in a human body and are therefore not easily repaired or replaced. A POSA at the
`
`time of invention would have understood these goals.
`
`B. Overview of the claimed invention
`38. The ’085 patent provides one set of method claims—claims 1–19.
`
`Claim 1 is the sole independent claim, and is reproduced below with labels [a]
`
`through [f] added for ease of reference:
`
`1. A method of manufacturing a stimulation lead having a proximal
`end and a distal end, comprising:
`
`[a] providing a plurality of conductive contacts located at an end of a
`lead body of the stimulation lead;
`
`[b] disposing a plurality of conductor wires in a plurality of conductor
`lumens formed in the lead body;
`
`[c] connecting at least one of the plurality of conductor wires to each
`of the conductive contacts;
`
`[d] placing spacers between pairs of adjacent conductive contacts,
`wherein portions of the conductor lumens are located beneath the
`plurality of conductive contacts and the spacers;
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`[e] inserting monofilament into at least one portion of at least one of
`the conductor lumens of the lead body that is not occupied by the
`conductor wires; and
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`[f] reflowing at least one of the spacers or monofilament into at least
`one portion of at least one of the conductor lumens not occupied by
`the conductive wires by heating the spacers and monofilament to a
`temperature to cause thermal flow or melting of at least one of the
`spacers or monofilament.
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`39. As stated in the preamble, claim 1 is a method for manufacturing an
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`implantable medical device—a stimulation lead having a proximal end and a distal
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`end. (Ex. 1001 at 8:10-12.) The characteristics of the stimulation lead itself are
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`described immediately below, followed by a discussion of the claimed method of
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`manufacturing the stimulation lead.
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`1.
`The claims define a stimulation lead having certain
`features.
`40. The method of independent claim 1 results in a stimulation lead with
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`proximal and distal ends (e.g., claim 1 at preamble above). The proximal end is the
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`end closest to the IPG, while the distal end is the end furthest from the IPG. The
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`stimulation lead includes conductive contacts located at one end of the lead body
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`(e.g., claim 1[a]), conductive/conductor wires in conductor lumens formed in the
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`lead body (e.g., claim 1[b], [c]), and spacers between pairs of adjacent conductive
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`contacts (e.g., claim 1[d], [e]). This basic structure for a stimulation lead was well-
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`known in the art, as at least Stoltz (Ex. 1005) and Black (Ex. 1008) show.
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`41.
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`In addition, independent claim 1 also recites inserting a monofilament
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`into a portion of a conductor lumen of the lead body that is not occupied by the
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`conductor wires; (e.g., claim 1[e]); and reflowing at least one of the spacers or
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`monofilament into at least one portion of at least one of the conductor lumens not
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`occupied by the conductive wires by heating the spacers and monofilament to a
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`temperature to cause thermal flow or melting of at least one of the spacers or
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`monofilament (e.g., claim 1 at [f]).
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`42. The structure of a stimulation lead made by the claimed process is
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`shown in figures 1 and 2 of the ’085 patent (see above), as well as in figures 3A,
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`5A, and 5B, which are reproduced below showing the distal end of the stimulation
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`lead.
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`(Ex. 1001 at FIGS. 3A, 5A, and 5B.)1
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`43. The figures above show an exemplary stimulation lead from several
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`perspectives. Figure 3A illustrates lead 16 with multiple electrode contacts 17 and
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`spacers 61 (highlighted in pink), and a radiopaque marker 30 as a distal tip. (See,
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`e.g., Ex. 1001 at 4:17-28.) The proximal end is illustrated in FIG. 3B. The
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`conductive contacts 40 at the proximal end would typically couple to an
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`implantable pulse generator, or perhaps a lead extender.
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`44. Figures 5A and 5B show conductive conductor wire 122, shown in
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`orange. The conductive wires 122 are disposed within conductor lumens 116 (e.g.,
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`a hollow bore within the lead body for one or more conductor wires), highlighted
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`in yellow and surrounding the stylet lumen 114. (Id., 5:30-56; 7:18-22.) The lead
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`body (e.g., insulated, multi-lumen tube) is formed, in part, by insulation section
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`112, shown in purple. (Id. at 5:34-45; 7:18-20.) The conductive wires are coupled
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`to electrode contact 17, which is highlighted in light blue in Figure 3A. (Id. at
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`5:34–56; 6:7-10.) The conductive wires couple the electrode contacts 17 at the
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`distal end of the lead to the conductive contacts 40 at the proximal end of the lead.
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`(Id. at FIG. 4; FIG. 6A, 6B, 5:13-18.)
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`1 In this declaration, colors in figures have been added for clarity and
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`emphasis, unless otherwise indicated.
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`45. Once the lead has been implanted within a patient, the electronics of
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`the implantable device generate stimulating pulses (i.e., electrical currents) that are
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`delivered via contacts 17 to the patient’s tissue to provide the desired therapy. (Id.
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`at 3:42–4:5.)
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`46. Dependent claims 2, 3, 11, and 12 further define materials of either
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`the spacers or monofilament used in the lead produced by the methods of the
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`claims. (Id., 8:32-52.) Those dependent claims require that either the spacers or the
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`monofilament is made of polyurethane, that the monofilament is made of a
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`thermoplastic material, that the monofilament is made from