throbber
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. 8,650,747
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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
`
`Introduction ...................................................................................................... 1
`I.
`Statement of Unpatentability Grounds for Claims 1-19 of the ’747 Patent .... 5
`II.
`III. Level of Ordinary Skill in the Art ................................................................... 6
`IV. Claim Construction .......................................................................................... 7
`V.
`Summary of the Unpatentability Argument for Independent Claim 1. ........... 9
`A. Overview of the ’747 patent ................................................................ 10
`B.
`The prosecution history ....................................................................... 16
`C.
`Independent claim 1 is unpatentable over Stolz, Ormsby, and
`Black. ................................................................................................... 18
`1.
`The basic parts of the stimulation lead assembly described
`
`by the ’747 patent claims were well-known by January
`2005. .......................................................................................... 19
`Disposing solid, non-conductive material radially
`underneath the conductive contacts and filling unoccupied
`portions of the conductor lumens would have been obvious
`by January 2005. ....................................................................... 24
`VI. Ground 1: The combination of Stolz, Ormsby, and Black renders
`obvious claims 1-19 of the ’747 patent. ...................................................... 27
`A.
`Independent claim 1 .......................................................................... 27
`1.
`“A stimulation lead assembly for making a lead, the
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`assembly comprising:” .............................................................. 27
`“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;” ................................................................ 28
`“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,” ................................................................ 29
`“a plurality of conductor wires disposed in the conductor
`lumens, wherein at least one of the conductor wires is
`
`4.
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`- i -
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`2.
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`2.
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`3.
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`

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`5.
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`6.
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`
`B.
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`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” ........................................................ 32
`“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,” . 36
`“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.” ...................................... 44
`Claim 2 ................................................................................................ 47
`1.
`“The lead assembly of claim 1,” ............................................... 47
`
`2.
`“comprising a plurality of spacers disposed between
`
`adjacent pairs of the conductive contacts.” ............................... 47
`C. Claim 3 ................................................................................................ 48
`1.
`“The lead assembly of claim 2,” ............................................... 48
`
`2.
`“wherein the spacers and the non-conductive material arc
`
`[sic] thermally fused together from heat applied to the lead
`assembly” .................................................................................. 48
`D. Claim 4 ................................................................................................ 49
`1.
`“The lead assembly of claim 3,” ............................................... 49
`
`2.
`“wherein a material of the spacers and the non-conductive
`
`material are a same material.” ................................................... 49
`Claim 5 ................................................................................................ 50
`1.
`“The lead assembly of claim 3,” ............................................... 50
`
`2.
`“wherein a material of the spacers and the non-conductive
`
`material are different materials.” .............................................. 50
`Claim 6 ................................................................................................ 52
`1.
`“The lead assembly of claim 1,” ............................................... 52
`
`
`E.
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`F.
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`- ii -
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`

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`2.
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`2.
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`3.
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`
`4.
`
`
`“wherein the plurality of electrically conductive contacts are
`located on a proximal end of the stimulation lead.” ................. 52
`G. Claim 7 ................................................................................................ 52
`1.
`“The lead assembly of claim 1,” ............................................... 52
`
`2.
`“wherein the plurality of electrically conductive contacts are
`
`located on a distal end of the stimulation lead.” ....................... 52
`H. Claim 8 ................................................................................................ 53
`1.
`“The lead assembly of claim 1,” ............................................... 53
`
`2.
`“wherein the non-conductive material is Polyurethane.” ......... 53
`
`Claim 9 ................................................................................................ 54
`1.
`“The lead assembly of claim 1” ................................................ 54
`
`2.
`“wherein the plurality of conductor lumens is exactly eight
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`conductor lumens.” ................................................................... 54
`Claim 10 .............................................................................................. 55
`1.
`“The lead assembly of claim 1,” ............................................... 55
`
`2.
`“wherein the non-conductive material fills the unoccupied
`
`portion of each of the conductor lumens.” ................................ 55
`Independent claim 11 ........................................................................ 56
`1.
`“A stimulation lead assembly for making a lead, the
`
`assembly comprising:” .............................................................. 56
`“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;” ................................................................ 56
`“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;” ................................................................ 57
`“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” .......... 57
`
`I.
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`J.
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`K.
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`- iii -
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`5.
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`
`L.
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`“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.” ..... 57
`Claim 12 .............................................................................................. 58
`1.
`“The lead assembly of claim 11,” ............................................. 58
`
`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.” ..................................... 58
`M. Claim 13 .............................................................................................. 58
`1.
`“The lead assembly of claim 11,” ............................................. 58
`
`2.
`“comprising a plurality of spacers disposed between
`
`adjacent pairs of the conductive contacts.” ............................... 59
`N. Claim 14 .............................................................................................. 59
`1.
`“The lead assembly of claim 13,” ............................................. 59
`
`2.
`“wherein the spacers and the non-conductive material are
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`thermally fused together from heat applied to the lead
`assembly.” ................................................................................. 59
`O. Claim 15 .............................................................................................. 59
`1.
`“The lead assembly of claim 11,” ............................................. 59
`
`2.
`“wherein a material of the spacers and the non-conductive
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`material are a same material.” ................................................... 59
`Claim 16 .............................................................................................. 60
`1.
`“The lead assembly of claim 11,” ............................................. 60
`
`2.
`“wherein a material of the spacers and the non-conductive
`
`material are different materials.” .............................................. 60
`Q. Claim 17 .............................................................................................. 60
`1.
`“The lead assembly of claim 11,” ............................................. 60
`
`2.
`“wherein the plurality of electrically conductive contacts are
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`located on a proximal end of the stimulation lead.” ................. 60
`R. Claim 18 .............................................................................................. 60
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`P.
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`- iv -
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`
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`S.
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`1.
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`2.
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`“The lead assembly of claim 11,” ............................................. 60
`“wherein the plurality of electrically conductive contacts are
`located on a distal end of the stimulation lead.” ....................... 61
`Claim 19 .............................................................................................. 61
`1.
`“The lead assembly of claim 11,” ............................................. 61
`
`2.
`“wherein the non-conductive material is thermally fused
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`with the lead body.” .................................................................. 61
`VII. Nevro is unaware of any secondary considerations of non-obviousness ...... 61
`VIII. Standing (37 C.F.R. § 42.104(a)) .................................................................. 62
`IX. Mandatory Notices (37 C.F.R. § 42.8) .......................................................... 62
`A.
`Real Party In Interest ........................................................................... 62
`B.
`Related Matters .................................................................................... 62
`C.
`Lead and Back-up Counsel ................................................................. 63
`D.
`Service Information ............................................................................. 64
`CERTIFICATION OF SERVICE (37 C.F.R. §§ 42.6(e), 42.105(a)) ....................... 1
`CERTIFICATE OF COMPLIANCE WITH TYPE-VOLUME LIMITATION,
`TYPEFACE REQUIREMENTS, AND TYPE STYLE
`REQUIREMENTS .......................................................................................... 2
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`- v -
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`EXHIBIT LIST
`
`Exhibit No.
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`Description
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`1001
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`1002
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`1003
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`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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`U.S. Patent No. 8,650,747 to Kuzma et al.
`
`U.S. Patent No. 8,650,747 File History
`
`Declaration of Michael Plishka
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`Curriculum Vitae of Michael Plishka
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`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)
`
`1011-1015
`
`Intentionally Left Blank
`
`1016
`
`1017
`
`U.S. Patent No. 6,473,653 to Schallhorn et al.
`
`U.S. Patent Publication No. 2002/0013537 to Rock
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`- vi -
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`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 8,650,747
`Petitioner Nevro Corporation (“Nevro”) requests inter partes review of
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`claims 1-19 of U.S. Patent No. 8,650,747 (“the ’747 patent”) (Ex. 1001), which is
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`assigned to Boston Scientific Neuromodulation Corporation (“BSNC”).
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`I.
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`Introduction
`
`The independent claims of the ’747 patent are directed to a “stimulation lead
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`assembly for making a lead”—namely, an implantable lead that provides electrical
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`stimulation therapy. In its most basic form, the stimulation lead described in the
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`’747 patent has an electrode array at a distal end, and a plurality of corresponding
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`conductive contacts at a proximal end. The distal-end electrodes stimulate the area
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`where the lead is implanted, and the contacts at the proximal end are typically
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`coupled to an implantable pulse generator. As applied herein, BSNC interprets
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`these claims in the co-pending district court litigation to require a plurality of
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`conductive wires that run the length of the lead body to couple the proximal end
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`contacts to their corresponding distal end electrodes. The conductive wires run
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`inside conductor lumens, which are hollow bores within the insulated lead body.
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`Insulating spacers are disposed between individual adjacent distal-end electrodes
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`and individual proximal-end contacts.
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`Part of this basic and well-known structure is laid out in the first three
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`elements of independent claim 1 of the ’747 patent:
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` - 1 -
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`Petition for Inter Partes Review of
`U.S. Patent No. 8,650,747
`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
`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, 8:21-38.
`
`The last two elements of claim 1 of the ’747 patent, focus very narrowly on
`
`unoccupied portions of the conductor lumen. The last two elements of claim 1 are
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`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
`
`
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` - 2 -
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`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 8,650,747
`temperature to cause the non-conductive material to thermally reflow
`or melt.
`Ex. 1001, 8:39-46.
`
`Independent claim 11 is broader than claim 1 because it does not recite the
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`thermal reflowing of the non-conductive material. It merely defines the basic
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`structure of an implantable lead known in the prior art, with “solid, non-conductive
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`material disposed, at least in part, radially underneath the conductive contacts
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`within portions of the conductor lumens not occupied by conductor wire.” Claim
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`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.
`Ex. 1001, 9:4-21.
`
`
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` - 3 -
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`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 8,650,747
`
`*
`
`*
`
`*
`
`By January 11, 2005 (the earliest possible priority date for the ’747 patent),
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`the field of implantable leads for providing electrical stimulation to a body was
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`already mature. See Ex. 1003, ¶¶1–33. Many prior-art implantable leads at that
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`time had the exact same basic structure recited in independent claims 1 and 11 of
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`the ’747 patent, including the conductor lumen structure that the patentee relied
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`upon to distinguish the Black reference. The claimed features, including the
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`conductor lumen configuration, is readily seen in the Stolz reference. See e.g., Ex.
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`1005, Stolz, FIGs. 4-5.
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`Moreover, the benefits of filling empty portions of a conductor lumen in an
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`implantable lead were also well-known in the prior art. Indeed, Stolz itself heats
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`and reflows thermoplastic material from its distal tip into an empty portions of its
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`conductor lumens. Ex. 1005, [0035], [0036], [0046]. Stolz also discusses filling an
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`isolation space below its contacts with epoxy. Id., [0046]. Further, the Ormsby
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`reference teaches why it is beneficial to fill empty conductor lumens, see e.g., Ex.
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`1006, Ormsby, 7:3-10, while the Black reference teaches the specific technique of
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`reflowing a spacer, for example, into the empty spaces of a conductor lumen
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`beneath a contact, Ex. 1008, 7:12-24.
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`Nevro will thus prove in the petition below that the ’747 patent claims are
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`nothing more than an incremental and obvious modification to well-known prior
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` - 4 -
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`

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`Petition for Inter Partes Review of
`U.S. Patent No. 8,650,747
`art stimulation leads, and lead manufacturing techniques, available by January
`
`2005.
`
`II.
`
`Statement of Unpatentability Grounds for Claims 1-19 of the ’747
`Patent
`
`Nevro requests inter partes review of claims 1-19 of the ’747 patent and a
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`determination that those claims are unpatentable based on the following ground:
`
`Ground Prior Art
`
`Stolz, Ormsby, and Black
`
`
`1
`
`Basis
`
`Claims Challenged
`
`§ 103
`
`1-19
`
`The earliest possible priority date on the face of the ’747 patent is January
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`
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`11, 2005. The prior art references cited for the ground above qualify as prior art to
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`the ’747 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 a 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. and qualifies as a
`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.
`
`
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` - 5 -
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`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 8,650,747
`Nevro also relies on the expert opinions of Michael Plishka (Ex. 1003) to
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`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
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`(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
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`of the ’747 patent, this appears to be the time period shortly before January 11,
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`2005.
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`Further, in ascertaining the appropriate level of ordinary skill in the art of a
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`patent, several factors should be considered including (1) the types of problems
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`encountered in the art; (2) the prior art solutions to those problems; (3) the rapidity
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`with which innovations are made; (4) the sophistication of the technology; and (5)
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`the educational level of active workers in the field of the patent. Moreover, a
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`POSA is a person who is presumed to be aware of the pertinent art, thinks along
`
`the line of conventional wisdom in the art, and is a person of ordinary creativity.
`
`In view of these factors, a POSA with respect to the ’747 patent disclosure
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`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)
`
`
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` - 6 -
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`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 8,650,747
`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
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`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 ’747 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).
`
`In this petition, Nevro challenges the claims of the ’747 patent under their
`
`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 ’747 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
`
`
`
`
` - 7 -
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`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 8,650,747
`lexicographer for any term. The only term that the patentee appears to have
`
`expressly construed in the ’747 patent specification is the term “lead.” And there,
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`the term is broadly construed as “an elongate device having any conductor or
`
`conductors, covered with an insulated sheath and having at least one electrode
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`contact attached to the elongate device, usually at the distal portion of the elongate
`
`device.” Ex. 1001, 1:34-38. This construction is consistent with the broadest
`
`reasonable interpretation of the claims of the ’747 patent.
`
`If the patent owner BSNC asserts that any other term 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
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`reserves the right to challenge in a different forum, such as in a U.S. District Court,
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`that a claim of the ’747 patent is indefinite or has a claim scope that differs from its
`
`broadest reasonable interpretation.1
`
`
`1 Specifically, the ’747 patent is part of BSNC’s suit against Nevro. See
`
`Mandatory Notices, Section IX.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
`
`
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` - 8 -
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`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 8,650,747
`Summary of the Unpatentability Argument for Independent Claim 1.
`
`V.
`
`The narrower independent claim 1 has every limitation of the broader
`
`independent claim 11. We thus summarize here Nevro’s argument for why
`
`independent claim 1 is unpatentable under 35 U.S.C. § 103 over Stolz, Ormsby,
`
`and Black. The arguments apply equally for independent claim 11. This summary
`
`explains the motivation to combine the key references. It also serves as an
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`overview of substantive positions that are explained in detail in the unpatentability
`
`ground set forth in more detail below.
`
`Stolz (Ex. 1005) is the base reference. It discloses a stimulation lead having
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`the same structure set forth in claim 1. Stolz teaches reflowing its distal tip into at
`
`least a portion of an unoccupied conductor lumen, and Stolz also discloses using
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`epoxy, a non-conductive material, to fill an isolation space beneath a contact. To
`
`the extent that Stolz is missing an express teaching of “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,” any gap is
`
`met with the Ormsby and Black references. Specifically, Ormsby (Ex. 1006)
`
`
`(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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` - 9 -
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`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 8,650,747
`provides the motivation to modify Stolz to fill the unoccupied portions of the
`
`conductor lumens and thermally fusing the same to the lead body. And Black (Ex.
`
`1008), which was considered during prosecution of the application which led to the
`
`’747 patent, teaches the specific technique of heating the spacers between the
`
`electrodes to reflow material into the spaces of a conductor lumen that are radially
`
`underneath a conductive contact, and thermally fusing the spacer material with the
`
`lead body—a teaching the Examiner did not appreciate at the time.
`
`A. Overview of the ’747 patent
`
`The ’747 patent is generally directed to the lead portion of an implantable
`
`system with a microstimulator 12 and a stimulation lead 18 having multiple
`
`electrodes 17 at a distal end of the lead. Figure 1 is illustrative and shows an array
`
`18 of electrodes 17 at the distal end of lead 16:
`
`Ex. 1001, FIG. 1; 3:46–57.
`
`
`
`
`
`
` - 10 -
`
`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 8,650,747
`The microstimulator 12 and stimulation lead 16 are typically implanted in a
`
`body. Id., 4:10–20. In one embodiment, it provides stimulation to a spine. Id.
`
`Ex. 1001, FIG. 2.
`
`
`
`Figures 3A and 5A and 5B from the ’747 patent, annotated below in color,
`
`show the basic structure of an implantable lead made by the claimed method:
`
`
`
`
` - 11 -
`
`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 8,650,747
`
`
`
`Ex. 1001 at FIGS. 3A, 5A, and 5B; See also Ex. 1003, ¶¶27–42.
`
`Figures 5A and 5B of the ’747 patent show how the conductor lumens 116
`
`(yellow) and conductors 122 (orange) are disposed in the stimulation lead body.
`
`Ex. 1001, 5:17-60. In the disclosed embodiment, the claimed stimulation lead 16
`
`has an electrode array 18 (blue) at its distal end (i.e., the end furthest from the
`
`signal generator). Ex. 1001, 4:10-66. The basic structural components are the
`
`conductor wires 122 (orange), the conductive contacts (i.e., electrodes) 17 (blue),
`
`and the spacers 61 (pink) placed between the conductive contacts. See id. Each
`
`electrode contact 17 receives the stimulation signals from an attached conductor
`
`
`
` - 12 -
`
`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 8,650,747
`122 that runs through a separate conductor lumen 116 (yellow) disposed along the
`
`length of the interior of the lead body. See Ex. 1003, ¶¶42–52.
`
`The ’747 patent specification also discloses how to fill void space where the
`
`conductors are coupled to the electrode contacts, and how to fill any empty
`
`conductor lumen in the multi-lumen tube body.2
`
`The described embodiment consists of placing a monofilament “inside the
`
`void space as shown in FIG. 6A, and inside any empty conductor lumens 116,” and
`
`then, with the assistance of shrink wrap, heating and reflowing either the
`
`monofilament, or the spacer, into the void space. See Ex. 1001, 7:35–45. See also,
`
`Ex. 1003, ¶¶53-56
`
`The specific embodiment in Figures 6A and 6B of the ’747 patent illustrate
`
`both the structure and the steps of filling void space where the conductors are
`
`coupled to the electrode contacts, and how to fill any empty conductor lumen in the
`
`lead body.
`
`
`2 In the district court litigation, the parties have agreed that the term
`
`conductor lumen be construed as “a hollow bore within the lead body for one or
`
`more conductor wires” and the term lead body as “an insulated, multi-lumen tube.”
`
`See Revised Final Joint Claim Chart filed October 6, 2017, Boston Scientific
`
`Corporation et al. v. Nevro Corp., Case No. 1:16-cv-01163 (D.E.D.).
`
`
`
`
` - 13 -
`
`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 8,650,747
`
`
`
`Ex. 1001 at FIGS. 6A and 6B; Ex. 1003, ¶¶53–70.
`
`In the figures, monofilament 60 (which may be made from non-conductive
`
`material) is inserted into the void space up to the point where the conductor 122
`
`attaches to the electrode 17 (i.e., the conductive contact). Element 70 denotes the
`
`void space near the electrode contact being at least partially filled by the
`
`monofilament 60. In the embodiment illustrated in Figure 6B, the structure of
`
`Figure 6A—including heat shrink tubing 65, spacer 61, and monofilament 60—is
`
`heated at 190 degrees Celsius for 30 seconds. This causes the spacer 61 and/or the
`
`
`
`
` - 14 -
`
`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 8,650,747
`monofilament 60 to reflow, and then to fill a portion of the void space 70 near the
`
`electrode contact 17. Ex. 1001, 6:11-44, see also Ex. 1003, ¶¶52-58.
`
`Claim 1 of the ’747 patent is broader than the embodiment set forth in
`
`Figures 6A and 6B. For example, it does not require insertion of monofilament. All
`
`it requires is that some sort of “solid, non-conductive material” is “disposed, at
`
`least in part, radially underneath the conductive contacts and filling the unoccupied
`
`portion of at least one of the conductor lumens.” Moreover, claim 1 is an
`
`“assembly”—i.e., a structure—and not a method claim. Consequently, claim 1 puts
`
`no restrictions on how the non-conductive material is “disposed, at least in part,
`
`radially underneath the conductive contacts and filling the unoccupied portion of at
`
`least one of the conductor lumens.” See Ex. 1003, ¶ 59.
`
`As noted, independent claim 11 is even broader than claim 1—it has the
`
`same structural features, but does not include claim 1’s “wherein” clause that is
`
`directed to thermally reflowing the non-conductive material disposed in the
`
`conductor lumen into the lead body. So if independent claim 1 is found to be
`
`unpatentable, so is independent claim 11. See id. at ¶ 60.
`
`The dependent claims cover additional obvious and incremental features.
`
`For example, dependent claims 2, 3, 13, and 14 further define inclusion of spacers
`
`and their relati

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