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`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`NEVRO CORP.
`Petitioner
`
`v.
`
`BOSTON SCIENTIFIC NEUROMODULATION CORP.
`Patent Owner
`
`_____________________
`
`Case IPR No. IPR2018-00147
`U.S. Patent 8,650,747
`_____________________
`
`DECLARATION OF MICHAEL PLISHKA
`
`Nevro Corp.
`Ex. 1003
`U.S. Patent No. 8,650,747
`
`

`

`TABLE OF CONTENTS
`
`I.
`Introduction ...................................................................................................... 1
`Summary of my opinions ................................................................................ 1
`II.
`III. Qualifications ................................................................................................... 1
`IV. Materials considered ........................................................................................ 3
`V.
`Relevant legal standards .................................................................................. 4
`A.
`Level of ordinary skill ........................................................................... 5
`B.
`Claim construction ................................................................................ 6
`C.
`Obviousness ........................................................................................... 8
`VI. The ’747 patent ................................................................................................ 9
`A. Overview of implantable stimulation leads ........................................... 9
`B.
`Overview of the claimed invention ..................................................... 12
`VII. Overview of the prior art. .............................................................................. 26
`A.
`Stolz overview ..................................................................................... 26
`B.
`Ormsby overview ................................................................................ 34
`C.
`Verness overview ................................................................................ 36
`D.
`Black overview .................................................................................... 37
`E.
`The Modern Plastics Encyclopedia overview ..................................... 40
`VIII. The combination of Stolz, Ormsby, and Black renders obvious claims 1-
`19 of the ’747 patent. ..................................................................................... 41
`A.
`Independent claim 1 ............................................................................ 43
`1.
`“A stimulation lead assembly for making a lead, the
`assembly comprising:” .............................................................. 43
`“a lead body defining a central lumen extending along the
`lead body and a plurality of conductor lumens disposed
`circumferentially around the central lumen and extending
`along the lead body;” ................................................................ 44
`“a plurality of electrically conductive contacts disposed
`along an end of the lead body, wherein a portion of each of
`the conductor lumens is disposed radially underneath the
`conductive contacts;” ................................................................ 45
`
`2.
`
`3.
`
`
`
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`- i -
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`

`

`5.
`
`6.
`
`“a plurality of conductor wires disposed in the conductor
`lumens, wherein at least one of the conductor wires is
`electrically connected to each conductive contact, wherein
`each conductor lumen comprises an occupied portion within
`which at least one of the conductor wires is disposed and an
`unoccupied portion in which none of the conductor wires is
`disposed, the unoccupied portion extending from an end of
`the conductor lumen; and” ........................................................ 48
`“a solid, non-conductive material disposed, at least in part,
`radially underneath the conductive contacts and filling the
`unoccupied portion of at least one of the conductor lumens,” . 51
`“wherein the non-conductive material is thermally fused
`with the lead body from heat applied to the lead assembly,
`which heat is at a temperature to cause the non-conductive
`material to thermally reflow or melt.” ...................................... 61
`Claim 2 ................................................................................................ 64
`1.
`“The lead assembly of claim 1,” ............................................... 64
`2.
`“comprising a plurality of spacers disposed between
`adjacent pairs of the conductive contacts.” ............................... 64
`Claim 3 ................................................................................................ 65
`1.
`“The lead assembly of claim 2,” ............................................... 65
`2.
`“wherein the spacers and the non-conductive material arc
`[sic] thermally fused together from heat applied to the lead
`assembly.” ................................................................................. 65
`Claim 4 ................................................................................................ 66
`1.
`“The lead assembly of claim 3,” ............................................... 66
`2.
`“wherein a material of the spacers and the non-conductive
`material are a same material.” ................................................... 67
`Claim 5 ................................................................................................ 68
`1.
`“The lead assembly of claim 3,” ............................................... 68
`2.
`“wherein a material of the spacers and the non-conductive
`material are different materials.” .............................................. 68
`Claim 6 ................................................................................................ 69
`1.
`“The lead assembly of claim 1,” ............................................... 69
`
`4.
`
`B.
`
`C.
`
`D.
`
`E.
`
`F.
`
`
`
`
`- ii -
`
`

`

`2.
`
`G.
`
`H.
`
`I.
`
`J.
`
`K.
`
`“wherein the plurality of electrically conductive contacts are
`located on a proximal end of the stimulation lead.” ................. 69
`Claim 7 ................................................................................................ 70
`1.
`“The lead assembly of claim 1,” ............................................... 70
`2.
`“wherein the plurality of electrically conductive contacts are
`located on a distal end of the stimulation lead.” ....................... 71
`Claim 8 ................................................................................................ 71
`1.
`“The lead assembly of claim 1,” ............................................... 71
`2.
`“wherein the non-conductive material is Polyurethane.” ......... 72
`Claim 9 ................................................................................................ 73
`1.
`“The lead assembly of claim 1” ................................................ 73
`2.
`“wherein the plurality of conductor lumens is exactly eight
`conductor lumens.” ................................................................... 73
`Claim 10 .............................................................................................. 74
`1.
`“The lead assembly of claim 1,” ............................................... 74
`2.
`“wherein the non-conductive material fills the unoccupied
`portion of each of the conductor lumens.” ................................ 74
`Independent claim 11 .......................................................................... 75
`1.
`“A stimulation lead assembly for making a lead, the
`assembly comprising:” .............................................................. 75
`“a lead body defining a central lumen extending along the
`lead body and a plurality of conductor lumens disposed
`circumferentially around the central lumen and extending
`along the lead body;” ................................................................ 76
`“a plurality of electrically conductive contacts disposed
`along an end of the lead body, wherein a portion of each of
`the conductor lumens is disposed radially underneath the
`conductive contacts;” ................................................................ 76
`“a plurality of conductor wires disposed in the conductor
`lumens, wherein at least one of the conductor wires is
`electrically connected to each conductive contact; and” .......... 76
`“a solid, non-conductive material disposed, at least in part,
`radially underneath the conductive contacts within portions
`of the conductor lumens not occupied by conductor wire.” ..... 77
`
`2.
`
`3.
`
`4.
`
`5.
`
`
`
`
`- iii -
`
`

`

`L.
`
`O.
`
`P.
`
`N.
`
`Claim 12 .............................................................................................. 77
`1.
`“The lead assembly of claim 11,” ............................................. 77
`2.
`“wherein the non-conductive material is thermally fused
`with the lead body from heat applied to the lead assembly,
`which heat is at a temperature to cause the non-conductive
`material, to thermally reflow or melt.” ..................................... 78
`M. Claim 13 .............................................................................................. 78
`1.
`“The lead assembly of claim 11,” ............................................. 78
`2.
`“comprising a plurality of spacers disposed between
`adjacent pairs of the conductive contacts.” ............................... 78
`Claim 14 .............................................................................................. 78
`1.
`“The lead assembly of claim 13,” ............................................. 78
`2.
`“wherein the spacers and the non-conductive material are
`thermally fused together from heat applied to the lead
`assembly.” ................................................................................. 79
`Claim 15 .............................................................................................. 79
`1.
`“The lead assembly of claim 11,” ............................................. 79
`2.
`“wherein a material of the spacers and the non-conductive
`material are a same material.” ................................................... 79
`Claim 16 .............................................................................................. 79
`1.
`“The lead assembly of claim 11,” ............................................. 79
`2.
`“wherein a material of the spacers and the non-conductive
`material are different materials.” .............................................. 80
`Claim 17 .............................................................................................. 80
`1.
`“The lead assembly of claim 11,” ............................................. 80
`2.
`“wherein the plurality of electrically conductive contacts are
`located on a proximal end of the stimulation lead.” ................. 80
`Claim 18 .............................................................................................. 80
`1.
`“The lead assembly of claim 11,” ............................................. 80
`2.
`“wherein the plurality of electrically conductive contacts are
`located on a distal end of the stimulation lead.” ....................... 81
`Claim 19 .............................................................................................. 81
`1.
`“The lead assembly of claim 11,” ............................................. 81
`- iv -
`
`Q.
`
`R.
`
`S.
`
`
`
`
`

`

`2.
`
`“wherein the non-conductive material is thermally fused
`with the lead body.” .................................................................. 81
`IX. Other evidence relevant to obviousness ........................................................ 81
`
`
`
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`- v -
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`

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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.
`
`8,650,747 (“the ’747 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
`
`connection with this proceeding. My compensation is not dependent in any way on
`
`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 1-19 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), and U.S. Patent No.
`
`6,216,045 to Black et al. (“Black,” Ex. 1008).
`
`III. Qualifications
`A copy of my curriculum vitae is provided as Ex. 1004.
`5.
`
`- 1 -
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`

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`6.
`
`During the course of my career, I have been exposed to multiple
`
`experiences that have equipped me to provide expert opinions on this case.
`
`7.
`
`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
`
`Chicago.
`
`8.
`
`I am an author of several publications, including publications related
`
`to electrical stimulation technologies, and am a named inventor on several U.S. and
`
`foreign utility and design patents, along with several currently pending patent
`
`applications.
`
`9.
`
`I also have deep design and engineering experience, working with
`
`clinicians to develop, test, prototype, and design numerous medical devices. In
`
`particular, at the Hines VA/Loyola position listed on my curriculum vitae, I
`
`designed and developed surface and implantable electrodes made from silicone and
`
`conductive wires and mesh. These were successfully used for monitoring and
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`stimulating people and animals in medical studies. These electrodes were used to
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`both monitor and stimulate various nerves (both on the surface of the skin, and
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`implanted) that control the bladder and colon. These electrodes helped spinal cord
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`injured patients control their bodily functions such as defecation and micturition.
`
`10. Following this, at Manan Medical Products, I designed and developed
`
`medical devices (e.g., interventional catheters and needles) and their
`
`- 2 -
`
`

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`manufacturing processes. These devices, and their manufacturing techniques,
`
`utilized various types of thermoplastic polyurethanes, and techniques to bond
`
`components together. Specifically, I developed manufacturing processes that
`
`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,
`
`thermoplastic tray forming and injection molding – processes that relied upon the
`
`melting and reflowing of polymers. I also experimented with heat shrink tubing as
`
`a means for holding and bonding plastics.
`
`11. At Manan, I also designed multi-lumen tubes to be used in medical
`
`devices, and built prototype devices using the heat joining processes described
`
`above. This included designing manufacturing processes and fixtures, and selecting
`
`particular materials for components to be joined, e.g., based on the properties of
`
`different types of materials.
`
`12. Following my tenure at Manan, I utilized and built upon this
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`knowledge at Allegiance Healthcare, designing similar processes, including tipping
`
`catheters and backfilling lumens.
`
`IV. Materials considered
`In formulating my opinions, I have relied upon my training,
`13.
`
`knowledge, and experience that are relevant to the ’747 patent. Furthermore, I have
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`- 3 -
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`

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`specifically considered the following documents, in addition to any other
`
`documents cited in this declaration:
`
`• The ’747 patent, Ex. 1001;
`
`• Stolz, Ex. 1005;
`
`• Ormsby, Ex. 1006;
`
`• Verness, Ex. 1007;
`
`• Black, Ex. 1008;
`
`• Modern Plastics Encyclopedia, Ex. 1010;
`
`• Cartmell, Ex. 1015;
`
`• Schallhorn et al., Ex. 1016; and
`
`• Rock, Ex. 1017.
`
`V. Relevant legal standards
`In forming my opinions, I have also relied upon various legal
`14.
`
`principles (as explained to me by Nevro’s counsel). My understanding of these
`
`principles is summarized below.
`
`15.
`
`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
`
`proceeding Nevro has the burden of proving that the challenged claims would have
`
`been unpatentable over the prior art by a preponderance of the evidence. I
`
`- 4 -
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`

`

`understand that “a preponderance of the evidence” is evidence sufficient to show
`
`that a fact is more likely true than it is not.
`
`16.
`
`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
`
`meaning and scope. With that understanding, I will consider the claims at issue
`
`here against the prior art from the perspective of a POSA, as further summarized
`
`below.
`
`A. Level of ordinary skill
`I understand that a claim must be analyzed from the perspective of a
`17.
`
`POSA at the time the claimed invention was allegedly invented by the patentee.
`
`Nevro’s counsel has informed me to consider the time period shortly before
`
`January 11, 2005, as the potential date of invention of the claims of the ’747 patent
`
`because that is the earliest filing date on the face of the ’747 patent.
`
`18.
`
`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
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`patent.
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`- 5 -
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`

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`19.
`
`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 ’747 patent would have had general knowledge of
`
`implantable medical devices and various related technologies as of January 11,
`
`2005.
`
`20. Based on my experience and my understanding of the legal principles
`
`summarized here, I believe that, in the context of the ’747 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
`I have been informed by Nevro’s counsel that, in this proceeding, the
`21.
`
`claims of an unexpired patent—like the ’747 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 ’747 patent as I perceive a POSA
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`- 6 -
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`

`

`would have understood them shortly before January 11, 2005, and in view of the
`
`’747 patent specification.
`
`22.
`
`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
`
`claim terms a special meaning that differs from the plain and ordinary meaning a
`
`POSA would ascribe to them. The only term that the patentee appears to have
`
`expressly construed in the ’747 patent specification is the term “lead.” And there,
`
`the term is broadly construed as “an elongate device having any conductor or
`
`conductors, covered with an insulated sheath and having at least one electrode
`
`contact attached to the elongate device, usually at the distal portion of the elongate
`
`device.” (Ex. 1001 at 1:34-38.) This construction is consistent with the broadest
`
`reasonable interpretation of the claims of the ’747 patent that I have applied in
`
`forming my opinions. At this time, I do not believe that any other terms in the
`
`challenged claims require an express construction.
`
`23.
`
`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 construe any term, then I reserve my right to review and
`
`potentially modify any opinions below in view of such constructions.
`
`- 7 -
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`

`

`C. Obviousness
`I have been informed by Nevro’s counsel that a patent claim is
`24.
`
`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
`
`the time of the alleged invention. Thus, in assessing whether a claim is obvious, I
`
`understand that I am to consider (1) the scope and content of the prior art; (2) the
`
`level of ordinary skill in the field of the invention; (3) the differences between the
`
`claimed invention and the prior art; and (4) any objective evidence of non-
`
`obviousness.
`
`25. 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
`
`technique to improve similar devices (methods, or products) in the same way, the
`
`claimed invention would likely have been obvious to a POSA. I have taken at least
`
`these rationales under consideration in analyzing the claims at issue here.
`
`- 8 -
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`

`

`VI. The ’747 patent
`26. The ’747 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
`
`electrode contacts and methods of making such leads.” (Ex. 1001 at 1:14–17.)
`
`A. Overview of implantable stimulation leads
`Implantable medical devices, including implantable stimulation leads,
`27.
`
`were well known long before the alleged invention of the ’747 patent. (Id. at 1:21–
`
`65.) For example, the ’747 patent itself identifies several exemplary implantable
`
`stimulation leads, such as cochlear stimulator systems and spinal cord stimulation
`
`systems. (Id. at 1:21–28.) The ’747 patent also references numerous prior art
`
`patents that describe additional stimulation leads, such as deep brain stimulation,
`
`cardiac stimulation, and peripheral nerve stimulation leads. (Id. at 1:21–65; 7:59–8:
`
`11.)
`
`28. Most spinal cord stimulation systems have two implantable
`
`components: “an implantable pulse generator (IPG) and at least one lead connected
`
`to one output of the IPG.” (Id. at 1:29–44.) The IPG is generally a multi-channel
`
`device that delivers electrical current through the electrode contacts of the lead.
`
`(Id.)
`
`- 9 -
`
`

`

`29. Below is an annotated depiction of an exemplary prior art stimulation
`
`system implanted within a patient, as shown in the prior-art Stolz reference:
`
`Implanted
`
`
`
`Lead with multiple
`
`
`
`
`
`
`
`(Ex. 1005, “Stolz” at FIG. 1.)
`
`30. The ’747 patent depicts a similar implantable system with a
`
`microstimulator 12 and a lead 18 having multiple electrodes:
`
`
`
`
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`- 10 -
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`

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`(Ex. 1001 at FIGS. 1, 2; 3:46-67, 4:1–20.)
`
`31. Figures 1 and 2 of the ’747 patent show a transverse, mid-sagittal
`
`view of a spinal cord and a generalized, implantable, spinal cord stimulation
`
`system. (Id. at FIGS. 1, 2; 3:46-67, 4:1–20.) In such a spinal cord stimulator (SCS)
`
`system, the lead 16 and the electrode array 18 are implanted in the epidural space
`
`20 of a patient in close proximity to the spinal cord 19. (Id.) Because of the lack of
`
`space where the electrode lead 16 exits the spinal column (the lead exit point 15),
`
`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.)
`
`32. The ’747 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 1:45–65.) Percutaneous leads have multiple electrode
`
`contacts along the distal portion of an elongate lead. (Id. at 1:55–65.) The ’747
`
`patent generally discusses the tradeoffs between the two types of leads. (Id.)
`
`33. The ’747 patent also generally discusses a method of making a multi-
`
`contact percutaneous lead. The ’747 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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`- 11 -
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`

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`building the leads.” (Id. at 1:66–2:6.) 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
`34. The ’747 patent provides two sets of device claims—claims 1–19,
`
`with claim 1 and claim 11 being the independent claims.
`
`35. Claim 1 of the ’747 patent is a stimulation lead assembly for making a
`
`lead having the structure described above. The preamble and the elements [a]-[c],
`
`below, simply lay out a few of the most basic parts of a stimulation lead—namely,
`
`the lead body with conductor lumens, a plurality of contacts (e.g., electrodes), and
`
`conductor wires:
`
`1. A stimulation lead assembly for making a lead, the assembly
`comprising:
`
`[a] a lead body defining a central lumen extending along the lead body
`and a plurality of conductor lumens disposed circumferentially around
`the central lumen and extending along the lead body;
`
`[b] a plurality of electrically conductive contacts disposed along an
`end of the lead body, wherein a portion of each of the conductor
`lumens is disposed radially underneath the conductive contacts;
`
`[c] a plurality of conductor wires disposed in the conductor lumens,
`wherein at least one of the conductor wires is electrically connected to
`
`- 12 -
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`

`

`each conductive contact, wherein each conductor lumen comprises an
`occupied portion within which at least one of the conductor wires is
`disposed and an unoccupied portion in which none of the conductor
`wires is disposed, the unoccupied portion extending from an end of
`the conductor lumen;
`
`(Ex. 1001 at 8:21-38.)
`
`36. Claim 1’s final elements [d] and [e] are directed to filling an
`
`unoccupied portion of the conductor lumens with a solid, non-conductive material.
`
`These claim features are reproduced below:
`
`[d] a solid, non-conductive material disposed, at least in part, radially
`underneath the conductive contacts and filling the unoccupied portion
`of at least one of the conductor lumens; …
`
`[e] wherein the non-conductive material is thermally fused with the
`lead body from heat applied to the lead assembly, which heat is at a
`temperature to cause the non-conductive material to thermally reflow
`or melt.
`
`(Id. at 8:39-46.)
`
`37. Claim 1 is directed to an “assembly;” it is not a method claim and it
`
`does not specify how the solid, non-conductive material is “disposed,” only where
`
`it is “disposed.”
`
`38.
`
`Independent claim 11 is also directed to an “assembly.” It is broader
`
`than claim 1. Claim 11, unlike claim 1, does not recite the thermal reflowing of the
`
`- 13 -
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`

`

`non-conductive material. It merely defines the basic structure of an implantable
`
`lead known in the prior art, with “solid, non-conductive material disposed, at least
`
`in part, radially underneath the conductive contacts within portions of the
`
`conductor lumens not occupied by conductor wire.” Claim 11 is reproduced for
`
`convenience below:
`
`11. A stimulation lead assembly for making a lead, the assembly
`comprising:
`
`[a] a lead body defining a central lumen extending along the lead body
`and a plurality of conductor lumens disposed circumferentially around
`the central lumen and extending along the lead body;
`
`[b] a plurality of electrically conductive contacts disposed along an
`end of the lead body, wherein a portion of each of the conductor
`lumens is disposed radially underneath the conductive contacts;
`
`[c] a plurality of conductor wires disposed in the conductor lumens,
`wherein at least one of the conductor wires is electrically connected to
`each conductive contact; and
`
`[d] a solid, non-conductive material disposed, at least in part, radially
`underneath the conductive contacts within portions of the conductor
`lumens not occupied by conductor wire.
`
`(Id. at 9:4-21.)
`
`39.
`
`Independent claim 1 results in a stimulation lead assembly for making
`
`a lead (e.g., claim 1 at preamble above). The stimulation lead includes a lead body
`
`(e.g., insulated, multi-lumen tube) having a central lumen and a plurality of
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`- 14 -
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`

`

`conductor lumens (e.g., a hollow bore within the lead body for one or more
`
`conductor wires) disposed circumferentially around the central lumen (e.g., claim
`
`1[a]), conductive contacts disposed along an end of the lead body, where a portion
`
`of the conductor lumens is disposed radially underneath the contacts (e.g., claim
`
`1[b], [c]), conductor wires disposed in the conductor lumens and connected to the
`
`contacts, (e.g., claim 1[c]). This basic structure for a stimulation lead was well-
`
`known in the art, as at least Stoltz (Ex. 1005) and Black (Ex. 1008) show.
`
`40.
`
`In addition, independent claim 1 also describes to filling an
`
`unoccupied portion of the conductor lumens with a solid, non-conductive material;
`
`(e.g., claim 1[d], [e]).
`
`41. The structure of a stimulation lead made by the claimed process is
`
`shown in figures 1 and 2 of the ’747 patent (see above), as well as in figures 3A,
`
`5A, and 5B, which are reproduced below showing the distal end of the stimulation
`
`lead.
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`- 15 -
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`

`

`
`(Ex. 1001 at FIGS. 3A, 5A, and 5B.)1
`
`42. The figures above show an exemplary stimulation lead from several
`
`
`
`perspectives. Figure 3A illustrates lead 16 with multiple electrode contacts 17 and
`
`spacers 61 (highlighted in pink), and a radiopaque marker 30 as a distal tip. (See,
`
`e.g., Ex. 1001 at 4:10-66.) The proximal end is illustrated in FIG. 3B. The
`
`
`1 In this declaration, colors in figures have been added for clarity and
`
`emphasis, unless otherwise indicated.
`
`- 16 -
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`

`

`conductive contacts 40 at the proximal end would typically couple to an
`
`implantable pulse generator, or perhaps a lead extender.
`
`43. Figures 5A and 5B show conductive conductor wire 122, shown in
`
`orange. (Ex. 1001, 5:46-60). The conductive wires 122 are disposed within
`
`conductor lumens 116, highlighted in yellow and surrounding the stylet lumen 114.
`
`(Id., 5:46-60, 7:18-27.) The lead body is formed, in part, by insulation section 112,
`
`shown in purple. (Id.). The conductive wires are coupled to electrode contact 17,
`
`which is highlighted in light blue in Figure 3A. (Id., 5:46-60, 6:11-14.) The
`
`conductive wires couple the electrode contacts 17 at the distal end of the lead to the
`
`conductive contacts 40 at the proximal end of the lead. (Id., FIG. 4; FIG. 6A, 6B,
`
`5:17-30.)
`
`44. Once the lead has been implanted within a patient, the electronics of
`
`the implantable device generate stimulating pulses (i.e., electrical currents) that are
`
`delivered via contacts 17 to the patient’s tissue to provide the desired therapy. (Id.,
`
`3:46–4:9.)
`
`45. Dependent claims