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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`NEVRO CORP.
`Petitioner
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`v.
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`BOSTON SCIENTIFIC NEUROMODULATION CORP.
`Patent Owner
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`PETITION FOR INTER PARTES REVIEW
`OF U.S. PATENT NO. 8,646,172
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`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent & Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`

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`
`
`TABLE OF CONTENTS
`
`2.
` 
`
`I. 
`Introduction ...................................................................................................... 1 
`Statement of Unpatentability Grounds for Claims 1-11 of the ’172 Patent .... 6 
`II. 
`III.  Level of Ordinary Skill in the Art ................................................................... 7 
`IV.  Claim Construction .......................................................................................... 8 
`V. 
`Summary of the Unpatentability Argument for Independent Claim 6 .......... 10 
`A.  Overview of the ’172 Patent ................................................................ 11 
`B. 
`The Prosecution History ...................................................................... 17 
`C. 
`Independent Claim 6 is Unpatentable Over Stolz, Ormsby, and
`Black .................................................................................................... 18 
`1.
`The steps of manufacturing the stimulation lead assembly
` 
`described by the ’172 patent claims were well-known by
`January 2005. ............................................................................ 19 
`Placing non-conductive material in empty portions of a
`conductor lumen, including radially beneath conductive
`contacts, and then heating and reflowing the non-conductive
`material would have been obvious by January 2005. ............... 23 
`VI.  Ground 1: The Combination of Stolz, Ormsby, and Black Renders
`Obvious Claims 1-5 of the ’172 Patent ...................................................... 28 
`A. 
`Independent Claim 1 ......................................................................... 28 
`1.
`“a method of manufacturing a stimulation lead comprising” ... 28 
` 
`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,” .......................................... 28 
`“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
`
`3.
` 
`
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`- i -
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`

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`
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`portion of the conductor lumens is disposed radially beneath
`the conductive contacts” ........................................................... 31 
`“after providing the lead body, conductively coupling at
`least one of the plurality of conductor wires to each of the
`conductive contacts” ................................................................. 34 
`“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” ................................................................. 37 
`Claim 2 ................................................................................................ 46 
`1.
`“The method of claim 1” ........................................................... 46 
` 
`2.
`“further comprising heating the non-conductive material to
` 
`cause the non-conductive material to thermally reflow or
`melt” .......................................................................................... 46 
`C.  Claim 3 ................................................................................................ 48 
`1.
`“The method of claim 1” ........................................................... 48 
` 
`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” ................................................................. 48 
`D.  Claim 4 ................................................................................................ 49 
`1.
`“The method of claim 1” ........................................................... 49 
` 
`2.
`“further comprising placing spacers between pairs of
` 
`adjacent conductive contacts” ................................................... 50 
`Claim 5 ................................................................................................ 51 
`1.
`“The method of claim 4” ........................................................... 51 
` 
`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” ........................................... 51 
`
`B. 
`
`E. 
`
`4.
` 
`
`5.
` 
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`- ii -
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`

`

`
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`VII.  Ground 2: The Combination of Stolz, Ormsby, Black, and Modern
`Plastics Encyclopedia Renders Obvious Claims 6-11 of the ’172
`Patent ............................................................................................................ 52 
`A. 
`Independent Claim 6 ......................................................................... 52 
`1.
`“A method of making a stimulation lead, comprising” ............ 56 
` 
`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” .............................. 56 
`“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” ........................................................... 57 
`“after providing the lead body, conductively coupling at
`least one of the plurality of conductor wires to each of the
`conductive contacts” ................................................................. 57 
`“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” ................................................................. 57 
`“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” .......................................................................................... 58 
`Claim 7 ................................................................................................ 61 
`1.
`“The method of claim 6” ........................................................... 61 
` 
`
`3.
` 
`
`4.
` 
`
`5.
` 
`
`6.
` 
`
`B. 
`
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`- iii -
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`
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`2.
` 
`
`“wherein the plurality of conductor lumens is exactly eight
`conductor lumens” .................................................................... 61 
`C.  Claim 8 ................................................................................................ 62 
`1.
`“The method of claim 6” ........................................................... 62 
` 
`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” ................................................................. 62 
`D.  Claim 9 ................................................................................................ 62 
`1.
`“The method of claim 6” ........................................................... 62 
` 
`2.
`“further comprising placing spacers between pairs of
` 
`adjacent conductive contacts” ................................................... 63 
`Claim 10 .............................................................................................. 63 
`1.
`“The method of claim 9” ........................................................... 63 
` 
`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” ............................................................................ 63 
`Claim 11 .............................................................................................. 63 
`1.
`“The method of claim 6” ........................................................... 63 
` 
`2.
`“wherein the non-conductive material comprises
` 
`polyurethane” ............................................................................ 64 
`VIII.  Nevro is Unaware of Any Secondary Considerations of Non-Obviousness . 65 
`IX.  Standing (37 C.F.R. § 42.104(a)) .................................................................. 65 
`X.  Mandatory Notices (37 C.F.R. § 42.8) .......................................................... 65 
`A. 
`Real Party In Interest ........................................................................... 65 
`B. 
`Related Matters .................................................................................... 66 
`C. 
`Lead and Back-up Counsel ................................................................. 66 
`
`E. 
`
`F. 
`
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`- iv -
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`D. 
`
`D.
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`Service Information ............................................................................. 67 
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`Service Information ............................................................................. 67
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`- v -
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`EXHIBIT LIST
`
`Exhibit No.
`
`Description
`
`1001
`
`1002
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`1003
`
`1004
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`1005
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`1006
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`1007
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`1008
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`1009
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`1010
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`1011
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`1012
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`1013
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`1014
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`1015
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`1016
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`1017
`
`U.S. Patent No. 8,646,172 to Kuzma et al.
`
`U.S. Patent No. 8,646,172 File History
`
`Declaration of Michael Plishka
`
`Curriculum Vitae of Michael Plishka
`
`U.S. Patent Publication No. 2003/0199950 to Stolz et al.
`
`WO 00/35349 to Ormsby et al.
`
`U.S. Patent Publication No. 2004/0215300 to Verness
`
`U.S. Patent No. 6,216,045 to Black et al.
`
`Intentionally Left Blank
`
`Modern Plastics Encyclopedia, Volume 63, Number 10A
`(October 1986)
`
`Intentionally Left Blank
`
`Intentionally Left Blank
`
`Intentionally Left Blank
`
`Intentionally Left Blank
`
`U.S. Patent No. 4,710,175 to Cartmell et al.
`
`U.S. Patent No. 6,473,653 to Schallhorn et al.
`
`U.S. Patent Publication No. 2002/0013537 to Rock
`
`- vi -
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`

`

`Petitioner Nevro Corporation (“Nevro”) requests inter partes review of
`
`Petition for Inter Partes Review of
`U.S. Patent No. 8,646,172
`
`
`claims 1-11 of U.S. Patent No. 8,646,1721 (“the ’172 patent”) (Ex. 1001), which is
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`assigned to Boston Scientific Neuromodulation Corporation (“BSNC”).
`
`I.
`
`Introduction
`
`The independent claims of the ’172 patent are directed to a “method of
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`manufacturing a stimulation lead”—namely, an implantable lead that provides
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`electrical stimulation therapy. In its most basic form, the stimulation lead described
`
`in the ’172 patent has an electrode array at a distal end, and a plurality of
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`corresponding conductive contacts at a proximal end. The distal-end electrodes
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`stimulate the area where the lead is implanted, and the contacts at the proximal end
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`are typically coupled to an implantable pulse generator. A plurality of conductive
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`wires run the length of the lead body to couple the proximal end contacts to their
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`corresponding distal end electrodes. As applied herein, BSNC interprets this claim
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`in the co-pending district court litigation to require a plurality of conductive wires
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`that run the length of the lead body to couple the proximal end contacts to their
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`corresponding distal end electrodes. The conductive wires run inside conductor
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`
`1 The ’172 patent issued from an application filed January 25, 2011 and was
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`thus filed prior to the enactment of the America Invents Act (“AIA”). Accordingly
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`this petition applies the pre-AIA versions of 35 U.S.C. §§ 102, 103, 112.
`
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`
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` - 1 -
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`

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`lumens, which are hollow bores within the insulated lead body. Insulating spacers
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`Petition for Inter Partes Review of
`U.S. Patent No. 8,646,172
`
`
`are disposed between individual adjacent distal-end electrodes and individual
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`proximal-end contacts.
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`Part of this basic and well-known structure is set forth by the method of the
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`’172 patent’s independent claim 1:
`
`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.
`
`
`
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` - 2 -
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`

`

`The last step [c] of claim 1 of the ’172 patent, focuses very narrowly on
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`Petition for Inter Partes Review of
`U.S. Patent No. 8,646,172
`
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`placing non-conductive material into at least a portion of one of the conductor
`
`lumens. The last element of claim 1 is reproduced below:
`
`[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.
`
`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,
`
`
`
`
` - 3 -
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`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 8,646,172
`
`
`[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;
`[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.
`
`*
`
`*
`
`*
`
`By January 11, 2005 (the earliest possible priority date for the ’172 patent),
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`the field of implantable leads for providing electrical stimulation to a body was
`
`already mature. Ex. 1003, Declaration of Michael Plishka, ¶¶1-33. Many prior-art
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`implantable leads at that time had the exact same basic structure recited in
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`independent claims 1 and 6 of the ’172 patent, including the conductor lumen
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`structure that the patentee relied upon to distinguish the primary Black reference
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`during prosecution. The claimed features, including the conductor lumen
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`
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` - 4 -
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`

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`configuration, is readily seen in the Stolz reference. See e.g., Ex. 1005, Stolz at
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`Petition for Inter Partes Review of
`U.S. Patent No. 8,646,172
`
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`FIGs. 4-5.
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`Moreover, the benefits of filling empty spaces in in an implantable lead,
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`such as an empty conductor lumen, were also well-known in the prior art. Indeed,
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`Stolz itself heats and reflows thermoplastic material from its distal tip into an
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`empty portions of its conductor lumens. Ex. 1005, [0035], [0036], [0046]. Stolz
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`also discusses filling an isolation space below its contacts with epoxy. Id. at
`
`[0046]. Further, the Ormsby reference teaches why it is beneficial to fill empty
`
`conductor lumens, see e.g., Ex. 1006, Ormsby at 7:3-10, while the Black reference
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`teaches the specific technique of reflowing a spacer, for example, into the spaces of
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`a conductor lumen beneath a contact, Ex. 1008, Black at 7:12-24. Finally, the time
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`and temperature features of independent claim 6 would have been obvious to a
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`person of ordinary skill in the art, as confirmed by the Modern Plastics
`
`Encyclopedia, Ex. 1010, and Nevro’s expert, Ex. 1003.
`
`Nevro will thus prove in the Petition below that the ’172 patent claims are
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`nothing more than an incremental and obvious modification to well-known prior
`
`art stimulation leads, and their manufacturing techniques, available by January
`
`2005.
`
`
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` - 5 -
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`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 8,646,172
`
`
`Statement of Unpatentability Grounds for Claims 1-11 of the ’172
`Patent
`
`II.
`
`Nevro requests inter partes review of claims 1-11 of the ’172 patent and a
`
`determination that those claims are unpatentable based on the following ground:
`
`Ground Prior Art
`1
`Stolz, Ormsby, and Black
`
`2
`
`Stolz, Ormbsy, and Black,
`further in view of the
`Modern Plastics
`Encyclopedia
`
`Basis
`§ 103
`
`§ 103
`
`Claims Challenged
`
`1-5
`
`6-11 (time and temperature
`parameters for reflowing
`thermoplastic material)
`
`The earliest possible priority date on the face of the ’172 patent is
`
`
`
`January 11, 2005. The prior art references cited for the ground above qualify as
`
`prior art to the ’172 patent under 35 U.S.C. § 102(b) for the following reasons:
`
` Stolz (Ex. 1005): U.S. Patent Publication No. 2003/0199950 to Stolz et
`al. qualifies as prior art under 35 U.S.C. § 102(b) at least because its
`publication date is October 23, 2003, which is more than one year before
`January 11, 2005.
` Ormsby (Ex. 1006): WO 00/35349 to Ormsby et al. qualifies as prior art
`under 35 U.S.C. § 102(b) at least because its international publication
`date is June 22, 2000, which is more than one year before January 11,
`2005.
` Black (Ex. 1008): U.S. Patent No. 6,216,045 to Black et al. qualifies as a
`prior art patent under 35 U.S.C. § 102(b) at least because it issued on
`April 10, 2001, which is more than one year before January 11, 2005.
`
`
`
`
` - 6 -
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`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 8,646,172
`
`
` Modern Plastics Encyclopedia (Ex. 1010): Modern Plastics
`Encyclopedia, 1986-1987, published by McGraw-Hill, Inc. in October
`1986 qualifies as a prior-art printed publication under 35 U.S.C. § 102(b)
`because it was publically available to interested persons for more than
`one year before January 11, 2005.
`
`Nevro also relies on the expert opinions of Michael Plishka (Ex. 1003) to
`
`prove that the challenged claims would have been obvious to a person of ordinary
`
`skill in the art by January 2005. Mr. Plishka’s qualifications are listed in his CV
`
`(Ex. 1004).
`
`III. Level of Ordinary Skill in the Art
`
`Patent claims must be analyzed from the perspective of a person of ordinary
`
`skill in the art (a “POSA”) at the time the claimed invention was allegedly invented
`
`by the patentee. If given the benefit of the earliest possible priority date on the face
`
`of the ’172 patent, this appears to be the time period shortly before January 11,
`
`2005.
`
`Further, in ascertaining the appropriate level of ordinary skill in the art of a
`
`patent, 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. Moreover, a
`
`
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` - 7 -
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`

`

`POSA is presumed to be aware of the pertinent art, thinks along the line of
`
`Petition for Inter Partes Review of
`U.S. Patent No. 8,646,172
`
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`conventional wisdom in the art, and is a person of ordinary creativity.
`
`In view of these factors, a POSA with respect to the ’172 patent disclosure
`
`would have had general knowledge of implantable medical devices and various
`
`related technologies as of January 11, 2005. Further, a POSA 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, and/or methods of their manufacture. See, Ex. 1003,
`
`¶¶17-20.
`
`IV. Claim Construction
`
`In considering the scope and meaning of the claims of an unexpired patent
`
`(such as the ’172 patent) in an inter partes review, the claim terms are to be given
`
`their broadest reasonable interpretation as understood by a POSA in light of the
`
`specification. Cuozzo Speed Techs., LLC v. Lee, 136 S.Ct. 2131, 2144-46 (2016);
`
`37 C.F.R. § 42.100(b). Under this standard, absent any special definitions, claim
`
`terms or phrases are given their ordinary and customary meaning, as would be
`
`understood by a POSA in the context of the entire specification. In re Translogic
`
`Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007).
`
`
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` - 8 -
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`

`

`In this Petition, Nevro challenges the claims of the ’172 patent under their
`
`Petition for Inter Partes Review of
`U.S. Patent No. 8,646,172
`
`
`broadest reasonable interpretations. The patentee did not use any unusual claim
`
`terms. Nor do any claim terms appear to be used outside their ordinary and
`
`customary meaning, as understood by a POSA and in view of the ’172 patent
`
`specification, under the broadest reasonable interpretation. The patentee did not
`
`provide a glossary, and the patentee does not appear to have acted as its own
`
`lexicographer for any term. 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, 1:36-40. This construction is consistent with the broadest
`
`reasonable interpretation of the claims of the ’172 patent.
`
`If the patent owner BSNC asserts that any other claim term or phrase
`
`specifically requires construction for this proceeding, Nevro reserves the right to
`
`challenge such construction, if necessary. And if the Board believes, after
`
`reviewing the Petition or the Patent Owner’s preliminary response, that any claim
`
`term requires additional briefing, Nevro is willing to provide supplemental
`
`briefing. Petitioner Nevro also reserves the right to challenge in a different forum,
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`
`
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` - 9 -
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`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 8,646,172
`
`such as in a U.S. District Court, that a claim of the ’172 patent is indefinite or has a
`
`claim scope that differs from its broadest reasonable interpretation.2
`
`V.
`
`Summary of the Unpatentability Argument for Independent Claim 6
`
`The narrower independent claim 6 has every limitation of the broader
`
`independent claim 1. We thus summarize here Nevro’s argument for why
`
`independent claim 6 is unpatentable under 35 U.S.C. § 103 over Stolz, Ormsby,
`
`and Black. The arguments apply equally for independent claim 1. This summary
`
`explains the motivation to combine the key references. It also serves as an
`
`overview of substantive positions that are explained in detail in the unpatentability
`
`ground set forth in more detail below.
`
`Stolz is the base reference. It discloses a stimulation lead having the same
`
`structure set forth in claim 1. Stolz teaches reflowing its distal tip into at least a
`
`
`2 Specifically, the ’172 patent is part of BSNC’s civil action against Nevro
`
`for patent infringement. See Mandatory Notices, Section X.B. infra. In that case
`
`the parties are currently engaged in claim construction. See Final Joint Claim Chart
`
`filed September 14, 2017, Boston Scientific Corporation et al. v. Nevro Corp.,
`
`Case No. 1:16-cv-01163 (D.E.D.); Revised Final Joint Claim Chart filed October
`
`6, 2017 in the same case; see also Nevro Corp.’s Opening Claim Construction
`
`Brief, filed on October 13, 2017 in the same case.
`
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` - 10 -
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`

`

`portion of an unoccupied conductor lumen, and Stolz also discloses using epoxy to
`
`Petition for Inter Partes Review of
`U.S. Patent No. 8,646,172
`
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`fill an isolation space beneath a contact.
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`To the extent that Stolz is missing an express teaching of “after providing
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`the lead body, placing non-conductive material into a portion of at least one of the
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`conductor lumens of the lead body, wherein at least a portion of the non-
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`conductive material is disposed radially beneath the conductive contacts,” any gap
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`is met with the Ormsby and Black references. Specifically, Ormsby (Ex. 1006)
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`provides the motivation to modify Stolz to fill the unoccupied portions of the
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`conductor lumens and thermally fusing the same to the lead body. And Black,
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`which was considered during prosecution of the application which led to the ’172
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`patent, teaches a specific technique of heating the spacers between the electrodes to
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`reflow material into the spaces of a conductor lumen that is radially underneath a
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`conductive contact, and thermally fusing the spacer material with the lead body—a
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`teaching the Examiner did not appreciate at the time. The Modern Plastics
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`Encyclopedia confirms that selecting particular ranges for temperature or time in
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`reflowing or melting operations are well within the grasp of a POSA, as confirmed
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`by Nevro’s expert and supported by well-settled case law.
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`A. Overview of the ’172 Patent
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`The ’172 patent is generally directed to a method for manufacturing the lead
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`portion 18 of an implantable system with a microstimulator 12. The lead portion
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`has multiple electrodes 17 at a distal end of the lead. Figure 1 is illustrative and
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`Petition for Inter Partes Review of
`U.S. Patent No. 8,646,172
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`shows an array 18 of electrodes 17 at the distal end of lead 16:
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`Ex. 1001, FIG. 1; 3:46–57.
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`The microstimulator 12 and stimulation lead 16 are typically implanted in a
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`body. Id., 4:12–22. In one embodiment, it provides stimulation to a spine. Id.
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`Ex. 1001, FIG. 2.
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`Figures 3A, 5A, and 5B from the ’172 patent, annotated below in color,
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`Petition for Inter Partes Review of
`U.S. Patent No. 8,646,172
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`show the basic structure of an implantable lead made by the claimed method:
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`
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`Ex. 1001 at FIGS. 3A, 5A, and 5B (annotated); See also Ex. 1003, ¶¶27-40.
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`Figures 5A and 5B of the ’172 patent show how the conductor lumens 116
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`(yellow) and conductors 122 (orange) are disposed in the stimulation lead body.
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`Ex. 1001, 5:36-62. In the disclosed embodiment, the claimed stimulation lead 16
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`has an electrode array 18 (blue) at its distal end (i.e., the end furthest from the
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`signal generator). Ex. 1001, 4:12-66. The basic structural components are the
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`conductor wires 122 (orange), the conductive contacts (i.e., electrodes) 17 (blue),
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`and the spacers 61 (pink) placed between the conductive contacts. See id. Each
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`electrode contact 17 receives the stimulation signals from an attached conductor
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`122 that runs through a separate conductor lumen 116 (yellow) disposed along the
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`Petition for Inter Partes Review of
`U.S. Patent No. 8,646,172
`
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`length of the interior of the lead body. See Ex. 1003, ¶41.
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`The ’172 patent specification also discloses how to fill void space where the
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`conductors are coupled to the electrode contacts, and how to fill any empty
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`conductor lumen3 in the insulated multi-lumen tube body. For example, the
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`described embodiment consists of placing a monofilament “inside the void space
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`as shown in FIG. 6A, and inside any empty conductor lumens 116,” and then, with
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`the assistance of shrink wrap, heating and reflowing either the monofilament, or
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`the spacer, into the void space. See Ex. 1001, 7:37-46.
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`The specific embodiment in Figures 6A and 6B of the ’172 patent illustrate
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`both the structure and the steps of filling the void space where the conductors are
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`coupled to an electrode contact.
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`3 In the district court litigation, the parties have agreed that the term
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`conductor lumen be construed as “a hollow bore within the lead body for one or
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`more conductor wires” and the term lead body as “an insulated, multi-lumen tube.”
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`See Revised Final Joint Claim Chart filed October 6, 2017, Boston Scientific
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`Corporation et al. v. Nevro Corp., Case No. 1:16-cv-01163 (D.E.D.).
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`Petition for Inter Partes Review of
`U.S. Patent No. 8,646,172
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`
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`Ex. 1001, FIGS. 6A and 6B (annotated); Ex. 1003, ¶¶41-51.
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`In the figures, monofilament 60 (which may be made from non-conductive
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`material) is inserted into the void space up to the point where the conductor 122
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`attaches to the electrode 17 (i.e., the conductive contact). Element 70 denotes the
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`void space near the electrode contact being at least partially filled by the
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`monofilament 60. In the embodiment illustrated in Figure 6B, the structure of
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`Figure 6A—including heat shrink tubing 65, spacer 61, and monofilament 60—is
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`heated at 190 degrees Celsius for 30 seconds. This causes the spacer 61 and/or the
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`monofilament 60 to melt or reflow, and then to fill a portion of the void space 70
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`near the electrode contact 17. Ex. 1001, 6:14-47, see also Ex. 1003, ¶¶ 52-103.
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`Claim 1 of the ’172 patent is broader than the embodiment set forth in
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`Petition for Inter Partes Review of
`U.S. Patent No. 8,646,172
`
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`Figures 6A and 6B. For example, it does not require monofilament. All it requires
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`is that some sort of “non-conductive material” is “placed” in “into a portion of at
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`least one of the conductor lumens of the lead body, wherein at least a portion of the
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`non-conductive material is disposed radially beneath the conductive contacts.” Ex.
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`1001, 8:40-44. On its face, claim 1 puts no restrictions on how the non-conductive
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