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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 IPR2018-00148
`U.S. Patent 8,646,172
`_____________________
`
`DECLARATION OF MICHAEL PLISHKA
`
`Nevro Corp.
`Ex. 1003
`U.S. Patent No. 8,646,172
`
`

`

`TABLE OF CONTENTS
`
`I. 
`Introduction ...................................................................................................... 1 
`Summary of my opinions ................................................................................ 1 
`II. 
`III.  Qualifications ................................................................................................... 2 
`IV.  Materials considered ........................................................................................ 4 
`V. 
`Relevant legal standards .................................................................................. 4 
`A. 
`Level of ordinary skill ........................................................................... 5 
`B. 
`Claim construction ................................................................................ 6 
`C. 
`Obviousness ........................................................................................... 8 
`VI.  The ’172 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 ..................................................................................... 27 
`B. 
`Ormsby overview ................................................................................ 35 
`C. 
`Verness overview ................................................................................ 36 
`D. 
`Black overview .................................................................................... 38 
`E. 
`The Modern Plastics Encyclopedia overview ..................................... 40 
`VIII.  The combination of Stolz, Ormsby, and Black renders obvious claims 1-5
`of the ’172 patent. .......................................................................................... 41 
`A. 
`Independent claim 1 ............................................................................ 43 
`1. 
`“a method of manufacturing a stimulation lead comprising:” .. 43 
`2. 
`“providing a lead body comprising an insulation section, the
`insulation section defining a central lumen extending along
`the insulation section and a plurality of conductor lumens
`extending along the insulation section and arranged around,
`and external to, the central lumen,” .......................................... 44 
`“the lead body further comprising a plurality of conductive
`contacts located along an axial end of the lead body, and a
`plurality of conductor wires, wherein each of the conductor
`wires is disposed within one of the plurality of conductor
`lumens and each of the conductor lumens of the plurality of
`
`3. 
`
`
`
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`- i -
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`

`

`5. 
`
`4. 
`
`conductor lumens has at least one of the conductor wires of
`the plurality of conductor wires disposed therein, wherein a
`portion of the conductor lumens is disposed radially beneath
`the conductive contacts” ........................................................... 46 
`“after providing the lead body, conductively coupling at
`least one of the plurality of conductor wires to each of the
`conductive contacts” ................................................................. 50 
`“after providing the lead body, placing non-conductive
`material into a portion of at least one of the conductor
`lumens of the lead body, wherein at least a portion of the
`non-conductive material is disposed radially beneath the
`conductive contacts” ................................................................. 53 
`Claim 2 ................................................................................................ 64 
`1. 
`“The method of claim 1,” .......................................................... 64 
`2. 
`“further comprising heating the non-conductive material to
`cause the non-conductive material to thermally reflow or
`melt” .......................................................................................... 64 
`Claim 3 ................................................................................................ 67 
`1. 
`“The method of claim 1” ........................................................... 67 
`2. 
`“wherein placing non-conductive material comprises placing
`the non-conductive material into a portion of each of the
`conductor lumens of the lead body, wherein at least a
`portion of the non-conductive material in each of the
`conductor lumens is disposed radially beneath the
`conductive contacts” ................................................................. 67 
`Claim 4 ................................................................................................ 68 
`1. 
`“The method of claim 1” ........................................................... 68 
`2. 
`“further comprising placing spacers between pairs of
`adjacent conductive contacts” ................................................... 69 
`Claim 5 ................................................................................................ 69 
`1. 
`“The method of claim 4” ........................................................... 69 
`2. 
`“further comprising heating the non-conductive material and
`spacers to cause the non-conductive material to thermally
`reflow or melt and to cause the non-conductive material and
`spacers to thermally fuse together” ........................................... 70 
`
`B. 
`
`C. 
`
`D. 
`
`E. 
`
`
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`- ii -
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`

`

`3. 
`
`4. 
`
`5. 
`
`F. 
`
`G. 
`
`H. 
`
`Independent Claim 6 ........................................................................... 71 
`1. 
`“A method of making a stimulation lead, comprising” ............ 73 
`2. 
`“providing a lead body comprising a [sic] insulation section,
`the insulation section defining a central lumen extending
`along the insulation section and a plurality of conductor
`lumens extending along the insulation section and arranged
`around, and external to, the central lumen” .............................. 73 
`“the lead body further comprising a plurality of conductive
`contacts located along an axial end of the lead body, and a
`plurality of conductor wires, wherein each of the conductor
`wires is disposed within one of the plurality of conductor
`lumens and each of the conductor lumens of the plurality of
`conductor lumens has at least one of the conductor wires of
`the plurality of conductor wires disposed therein, wherein a
`portion of the conductor lumens is disposed radially beneath
`the conductive contacts” ........................................................... 73 
`“after providing the lead body, conductively coupling at
`least one of the plurality of conductor wires to each of the
`conductive contacts” ................................................................. 74 
`“after providing the lead body, placing non-conductive
`material into a portion of at least one of the conductor
`lumens of the lead body, wherein at least a portion of the
`non-conductive material is disposed radially beneath the
`conductive contacts” ................................................................. 74 
`“after placing the non-conductive material, heating the non-
`conductive material at a temperature in a range of 140 to 250
`degrees Celsius for a period in a range of 15 to 120 seconds
`to cause the non-conductive material to thermally reflow or
`melt” .......................................................................................... 74 
`Claim 7 ................................................................................................ 79 
`1. 
`“The method of claim 6” ........................................................... 79 
`2. 
`“wherein the plurality of conductor lumens is exactly eight
`conductor lumens” .................................................................... 79 
`Claim 8 ................................................................................................ 80 
`1. 
`“The method of claim 6” ........................................................... 80 
`
`6. 
`
`
`
`
`- iii -
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`

`

`2. 
`
`I. 
`
`J. 
`
`“wherein placing non-conductive material comprises placing
`the non-conductive material into a portion of each of the
`conductor lumens of the lead body, wherein at least a
`portion of the non-conductive material in each of the
`conductor lumens is disposed radially beneath the
`conductive contacts” ................................................................. 80 
`Claim 9 ................................................................................................ 80 
`1. 
`“The method of claim 6” ........................................................... 80 
`2. 
`“further comprising placing spacers between pairs of
`adjacent conductive contacts” ................................................... 80 
`Claim 10 .............................................................................................. 81 
`1. 
`“The method of claim 9” ........................................................... 81 
`2. 
`“wherein heating the non-conductive material comprises
`heating the non-conductive material and spacers to cause the
`non-conductive material to thermally reflow or melt and to
`cause the non-conductive material and spacers to thermally
`fuse together” ............................................................................ 81 
`Claim 11 .............................................................................................. 81 
`1. 
`“The method of claim 6” ........................................................... 81 
`2. 
`“wherein the non-conductive material comprises
`polyurethane” ............................................................................ 81 
`IX.  Other evidence relevant to obviousness ........................................................ 83 
`
`
`K. 
`
`
`
`
`- iv -
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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.
`
`8,646,172 (“the ’172 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 1-5 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). Claims 6-11 would have been
`
`obvious over Stolz, Ormsby, Black, and Modern Plastics Encyclopedia, Volume
`
`63, Number 10A (October 1986) (“Modern Plastics Encyclopedia,” Ex. 1010.)
`
`- 1 -
`
`

`

`III. Qualifications
`5.
`A copy of my curriculum vitae is provided as Ex. 1004.
`
`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
`
`stimulating people and animals in medical studies. These electrodes were used to
`
`both monitor and stimulate various nerves (both on the surface of the skin, and
`
`implanted) that control the bladder and colon. These electrodes helped spinal cord
`
`injured patients control their bodily functions such as defecation and micturition.
`
`- 2 -
`
`

`

`10. Following this, at Manan Medical Products, I designed and developed
`
`medical devices (e.g., interventional catheters and needles) and their
`
`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
`
`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
`
`knowledge at Allegiance Healthcare, designing similar processes, including tipping
`
`catheters and backfilling lumens.
`
`- 3 -
`
`

`

`IV. Materials considered
`13.
`In formulating my opinions, I have relied upon my training,
`
`knowledge, and experience that are relevant to the ’172 patent. Furthermore, I have
`
`specifically considered the following documents, in addition to any other
`
`documents cited in this declaration:
`
` The ’172 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
`14.
`In forming my opinions, I have also relied upon various legal
`
`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
`
`- 4 -
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`

`

`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
`
`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
`17.
`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.
`
`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 ’172 patent
`
`because that is the earliest filing date on the face of the ’172 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
`
`- 5 -
`
`

`

`of the technology; and (5) the educational level of active workers in the field of the
`
`patent.
`
`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 ’172 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 ’172 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
`21.
`I have been informed by Nevro’s counsel that, in this proceeding, the
`
`claims of an unexpired patent—like the ’172 patent—are given their broadest
`
`reasonable interpretation as understood by a POSA in light of the patent
`
`- 6 -
`
`

`

`specification. Accordingly, in forming my opinions, I have applied the broadest
`
`reasonable interpretation of the claims of the ’172 patent as I perceive a POSA
`
`would have understood them shortly before January 11, 2005, and in view of the
`
`’172 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 ’172 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 1:36-40.) This construction is consistent with the broadest
`
`reasonable interpretation of the claims of the ’172 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
`
`- 7 -
`
`

`

`tribunal chooses to construe any term, then I reserve my right to review and
`
`potentially modify any opinions below in view of such constructions.
`
`C. Obviousness
`24.
`I have been informed by Nevro’s counsel that a patent claim is
`
`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
`
`- 8 -
`
`

`

`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.
`
`VI. The ’172 patent
`26. The ’172 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 1:15–20.)
`
`A. Overview of implantable stimulation leads
`27.
`Implantable medical devices, including implantable stimulation leads,
`
`were well known long before the alleged invention of the ’172 patent. (Id. at 1:23–
`
`67.) For example, the ’172 patent itself identifies several exemplary implantable
`
`stimulation leads, such as cochlear stimulator systems and spinal cord stimulation
`
`systems. (Id. at 1:23–30.) The ’172 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 1:23–67; 7:60–8:
`
`13.)
`
`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 1:61–46.) The IPG is generally a multi-channel
`
`- 9 -
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`

`

`device that delivers electrical current through the electrode contacts of the lead.
`
`(Id.)
`
`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 microstimulator
`
`Lead with multiple electrodes
`
`
`
`
`(Ex. 1005, “Stolz” at FIG. 1.)
`
`30. The ’172 patent depicts a similar implantable system with a
`
`microstimulator 12 and a lead 18 having multiple electrodes:
`
`
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`- 10 -
`
`

`

`
`(Ex. 1001 at FIGS. 1, 2; 3:48–4:22.)
`
`31. Figures 1 and 2 of the ’172 patent show a transverse, mid-sagittal
`
`
`
`view of a spinal cord and a generalized, implantable, spinal cord stimulation
`
`system. (Id. at FIGS. 1, 2; 3:48–4:22.) 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.)
`
`- 11 -
`
`

`

`32. The ’172 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 1:47–67.) Percutaneous leads have multiple electrode
`
`contacts along the distal portion of an elongate lead. (Id. at 1:57–67.) The ’172
`
`patent generally discusses the tradeoffs between the two types of leads. (Id.)
`
`33. The ’172 patent also generally discusses a method of making a multi-
`
`contact percutaneous lead. The ’172 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
`
`building the leads.” (Id. at 2:2-8.) 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 ’172 patent provides two sets of method claims—claims 1–11,
`
`with claim 1 and claim 6 being the independent claims. The preamble and the
`
`elements, below, simply lay out a few of the most basic parts of a stimulation
`
`- 12 -
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`

`

`lead—namely, the lead body with conductor lumens, a plurality of contacts (e.g.,
`
`electrodes), and conductor wires:
`
`1. A method of manufacturing a stimulation lead comprising:
`[a] providing a lead body comprising an insulation section, the
`insulation section defining a central lumen extending along the
`insulation section and a plurality of conductor lumens extending
`along the insulation section and arranged around, and external to, the
`central lumen,
`
`[a1] the lead body further comprising a plurality of conductive
`contacts located along an axial end of the lead body, and a plurality
`of conductor wires,
`
`[a2] wherein each of the conductor wires is disposed within one
`of the plurality of conductor lumens and each of the conductor
`lumens of the plurality of conductor lumens has at least one of the
`conductor wires of the plurality of conductor wires disposed therein,
`
`[a3] wherein a portion of the conductor lumens is disposed
`radially beneath the conductive contacts;
`[b] after providing the lead body, conductively coupling at least one
`of the plurality of conductor wires to each of the conductive
`contacts;…
`
`Ex. 1001, the ’172 patent, at 8:20-39.
`35. The last step [c] of claim 1 of the ’172 patent, focuses very narrowly
`
`on placing non-conductive material into at least a portion of one of the conductor
`
`lumens. The last element of claim 1 is reproduced below:
`
`- 13 -
`
`

`

`[c] after providing the lead body, placing non-conductive material
`into a portion of at least one of the conductor lumens of the lead
`body, wherein at least a portion of the non-conductive material is
`disposed radially beneath the conductive contacts.
`Ex. 1001 at 8:40-44.
`
`36.
`
`Independent claim 6 adds only the step [d] of heating the non-
`
`conductive material at a temperature and time range to cause the non-conductive
`
`material to thermally reflow or melt. Claim 6 is reproduced for convenience below:
`
`6. A method of manufacturing a stimulation lead comprising;
`[a] providing a lead body comprising a [sic] insulation section, the
`insulation section defining a central lumen extending along the
`insulation section and a plurality of conductor lumens extending
`along the insulation section and arranged around, and external to, the
`central lumen,
`
`[a1] the lead body further comprising a plurality of conductive
`contacts located along an axial end of the lead body, and a plurality
`of conductor wires,
`
`[a2] wherein each of the conductor wires is disposed within one
`of the plurality of conductor lumens and each of the conductor
`lumens of the plurality of conductor lumens has at least one of the
`conductor wires of the plurality of conductor wires disposed therein,
`
`[a3] wherein a portion of the conductor lumens is disposed
`radially beneath the conductive contacts;
`
`- 14 -
`
`

`

`[b] after providing the lead body, conductively coupling at least one
`of the plurality of conductor wires to each of the conductive
`contacts;
`[c] after providing the lead body, placing non-conductive material
`into a portion of at least one of the conductor lumens of the lead
`body, wherein at least a portion of the non-conductive material is
`disposed radially beneath the conductive contacts; and
`[d] after placing the non-conductive material, heating the non-
`conductive material at a temperature in a range of 140 to 250
`degrees Celsius for a period in a range of 15 to 120 seconds to cause
`the non-conductive material to thermally reflow or melt.
`Ex. 1001 at 8:61-10:3.
`
`37. The independent claims result in methods of manufacturing a
`
`stimulation lead including providing a lead body (e.g., insulated, multi-lumen tube)
`
`having a central lumen and a plurality of conductor lumens (e.g., a hollow bore
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`within the lead body for one or more conductor wires), conductive contacts
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`disposed along an end of the lead body, where a portion of the conductor lumens is
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`disposed radially underneath the contacts, conductor wires disposed in the
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`conductor lumens and connected to the contacts. This basic structure for a
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`stimulation lead was well-known in the art, as at least Stoltz (Ex. 1005) and Black
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`(Ex. 1008) show.
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`38.
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`In addition, independent claim 1 also describes placing non-
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`conductive material into a portion of at least one of the conductor lumens of the
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`lead body.
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`39. The structure of a stimulation lead made by the claimed process is
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`shown in figures 1 and 2 of the ’172 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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`40. 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 5:36-62.) 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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`41. Figures 5A and 5B of the ’172 patent show how the conductor lumens
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`116 (yellow) and conductors 122 (orange) are disposed in the stimulation lead
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`body. (Ex. 1001, 5:36-62; 7:18-29.) In the disclosed embodiment, the claimed
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`stimulation lead 16 has an electrode array 18 (blue) at its distal end (i.e., the end
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`furthest from the signal generator). (Ex. 1001, 4:12-66; 7:20-29.) The basic
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`structural components are the conductor wires 122 (orange), the conductive
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`contacts (i.e., electrodes) 17 (blue), and the spacers 61 (pink) placed between the
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`conductive contacts. (See id., 4:12-66; 6:14-17; 7:20-29.) Each electrode contact
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`17 receives the stimulation signals from an attached conductor 122 that runs
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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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`through a separate conductor lumen 116 (yellow) disposed along the length of the
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`interior of the lead body (Id. at FIG. 4; FIG. 6A, 6B, 5:19-24.)
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`42. 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 3:48–4:11.)
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`43. The dependent claims cover additional obvious and incremental
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`features. For example, dependent claim 2, restates the general reflowing step
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`already discussed with reference to independent claim 6, but without any
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`temperature or time specification. (Ex. 1001, 8:45-47.)
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`44. Dependent claims 3 and 8 further specify that the material fills the
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`unoccupied portion of each of the conductor lumens, instead of only at least one.
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`(Ex. 1001, 8:48-53; 10:6-11.) Dependent claims 4 and 9 further define spacers
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`placed between pairs of adjacent conductive contacts. (Ex. 1001, 8:54-55; 10:12-
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`13.) This feature is well known and disclosed by both Stolz and Black.
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`45. Dependent claims 5 and 10 further specify that the heating of the non-
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`conductive material and spacers cause them to thermally fuse together—which is
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`obvious in view of the applied art. (Ex. 1001, 8:56-60; 10:14-18.)
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`46. Dependent claim 7 further defines that there is exactly eight conductor
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`lumens. (Ex. 1001, 10:4-5.)This is the same as Stolz’s disclosed embodiment.
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