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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. 7,891,085
`
`
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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
`
`
`
`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 7,891,085
`
`TABLE OF CONTENTS
`
`2.
` 
`
`2.
` 
`
`3.
` 
`
`I. 
`Introduction ...................................................................................................... 1 
`Statement of Unpatentability Grounds for Claims 1-19 of the ’085 Patent .... 4 
`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 ’085 patent ................................................................ 10 
`B. 
`The prosecution history ....................................................................... 15 
`C. 
`Independent claim 1 is unpatentable over Stolz, Ormsby, Black,
`and the knowledge of a POSA. ........................................................... 16 
`1.
`The stimulation lead structure described by the ’085 patent
` 
`claims was well-known. ............................................................ 16 
`The claimed method of manufacturing the lead in the ’085
`patent would have been obvious by January 2005. .................. 19 
`VI.  Ground 1: The combination of Stolz, Ormsby, Black and the
`knowledge of a POSA renders obvious claims 1-3, 6-12, and 14-17 of
`the ’085 patent. ............................................................................................. 24 
`A. 
`Independent claim 1 .......................................................................... 24 
`1.
`“A method of manufacturing a stimulation lead having a
` 
`proximal end and a distal end, comprising:” ............................ 24 
`“providing a plurality of conductive contacts located at an
`end of a lead body of the stimulation lead;” ............................. 24 
`“disposing a plurality of conductor wires in a plurality of
`conductor lumens formed in the lead body;” ............................ 26 
`“connecting at least one of the plurality of conductor wires
`to each of the conductive contacts;” ......................................... 27 
`“placing spacers between pairs of adjacent conductive
`contacts,” ................................................................................... 30 
`“wherein portions of the conductor lumens are located
`beneath the plurality of conductive contacts and the
`spacers;” .................................................................................... 31 
`
`4.
` 
`
`5.
` 
`
`6.
` 
`
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`- i -
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`

`

`7.
` 
`
`8.
` 
`
`B. 
`
`Petition for Inter Partes Review of
`U.S. Patent No. 7,891,085
`“inserting monofilament into at least one portion of at least
`one of the conductor lumens of the lead body that is not
`occupied by the conductor wires;” ............................................ 32 
`“reflowing at least one of the spacers or monofilament into
`at least one portion of at least one of the conductor lumens
`not occupied by the conductive wires by heating the spacers
`and monofilament to a temperature to cause thermal flow or
`melting of at least one of the spacers or monofilament.” ......... 39 
`Claim 2 ................................................................................................ 45 
`1.
`“The method of claim 1,” .......................................................... 45 
` 
`2.
`“wherein either the spacers or monofilament is
` 
`polyurethane.” ........................................................................... 46 
`C.  Claim 3 ................................................................................................ 47 
`1.
`“The method of claim 2,” .......................................................... 47 
` 
`2.
`“wherein the monofilament is a thermoplastic material.” ........ 47 
` 
`D.  Claim 6 ................................................................................................ 47 
`1.
`“The method of claim 1,” .......................................................... 47 
` 
`2.
`“wherein the spacers are oversized in diameter, relative to a
` 
`predetermined final diameter of the lead.” ............................... 47 
`Claim 7 ................................................................................................ 49 
`1.
`“The method of claim 1,” .......................................................... 49 
` 
`2.
`“wherein conductive contacts are in the form of rings.” .......... 49 
` 
`Claim 8 ................................................................................................ 50 
`1.
`“The method of claim 1,” .......................................................... 50 
` 
`2.
`“wherein the conductive contacts are electrode contacts on
` 
`the lead.” ................................................................................... 50 
`G.  Claim 9 ................................................................................................ 50 
`1.
`“The method of claim 1,” .......................................................... 50 
` 
`2.
`“wherein the conductive contacts are connector contacts on
` 
`the proximal end of the lead.” ................................................... 50 
`H.  Claim 10 .............................................................................................. 51 
`
`E. 
`
`F. 
`
`
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`- ii -
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`

`

`1.
` 
`2.
` 
`
`I. 
`
`J. 
`
`Petition for Inter Partes Review of
`U.S. Patent No. 7,891,085
`“The method of claim 1,” .......................................................... 51 
`“wherein the step of connecting a conductor wire to each of
`the electrode contacts is accomplished by welding each
`conductor wire to each respective contact.” ............................. 51 
`Claim 11 .............................................................................................. 53 
`1.
`“The method of claim 1” ........................................................... 53 
` 
`2.
`“wherein the monofilament is a different material than the
` 
`spacers.” .................................................................................... 53 
`Claim 12 .............................................................................................. 54 
`1.
`“The method of claim 1,” .......................................................... 54 
` 
`2.
`“wherein the monofilament is the same material as the
` 
`spacers.” .................................................................................... 54 
`K.  Claim 14 .............................................................................................. 55 
`1.
`“The method of claim 1,” .......................................................... 55 
` 
`2.
`“wherein the plurality of electrically conductive contacts are
` 
`located on the proximal end of the stimulation lead.” .............. 55 
`Claim 15 .............................................................................................. 56 
`1.
`“The method of claim 1,” .......................................................... 56 
` 
`2.
`“wherein the plurality of electrically conductive contacts are
` 
`located on the distal end of the stimulation lead.” .................... 56 
`M.  Claim 16 .............................................................................................. 56 
`1.
`“The method of claim 1,” .......................................................... 56 
` 
`2.
`“wherein the plurality of electrically conductive contacts and
` 
`the spacers form a substantially cylindrical body and
`wherein the conductor lumens are defined within the
`substantially cylindrical body.” ................................................ 57 
`N.  Claim 17 .............................................................................................. 58 
`1.
`“The method of claim 1,” .......................................................... 58 
` 
`2.
`“wherein the monofilament is disposed in an orientation
` 
`parallel to the conductor wires.” ............................................... 58 
`
`L. 
`
`
`
`- iii -
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`

`

`B. 
`
`Petition for Inter Partes Review of
`U.S. Patent No. 7,891,085
`VII.  Ground 2: The combination of Stolz, Ormsby, Black, and the
`knowledge of a POSA, further in view of the Modern Plastics
`Encyclopedia, renders obvious claims 4, 5, and 13 of the ’085 patent. .. 59 
`A.  Claim 4 ................................................................................................ 63 
`1.
`“The method of claim 3,” .......................................................... 63 
` 
`2.
`“wherein the heat applied is between about 140 to 250
` 
`degrees Celsius.” ....................................................................... 63 
`Claim 5 ................................................................................................ 64 
`1.
`“The method of claim 4,” .......................................................... 64 
` 
`2.
`“wherein the heat is applied for between about 15 to 120
` 
`seconds.” ................................................................................... 64 
`C.  Claim 13 .............................................................................................. 66 
`1.
`“The method of claim 5,” .......................................................... 66 
` 
`2.
`“wherein the heat applied is about 160 degrees Celsius for
` 
`about 40 seconds.” .................................................................... 67 
`VIII.  Ground 3: The combination of Stolz, Ormsby, Black, and the
`knowledge of a POSA, further in view of Wessman, render obvious
`claim 18 of the ’085 patent. ......................................................................... 67 
`A.  Claim 18 .............................................................................................. 67 
`1.
`“The method of claim 1,” .......................................................... 67 
` 
`2.
`“placing a heat shrink tubing around the spacers, conductive
` 
`contacts, and monofilament and removing the heat shrink
`tubing after reflowing at least one of the spacers or
`monofilament.” ......................................................................... 68 
`IX.  Ground 4: The combination of Stolz, Ormsby, Black, the knowledge
`of a POSA, and Wessman, further in view of Saab, render obvious
`claim 19 of the ’085 patent. ......................................................................... 70 
`A.  Claim 19 .............................................................................................. 70 
`1.
`“The method of claim 18,” ........................................................ 70 
` 
`2.
`“wherein the heat shrink tubing is made from a material
` 
`selected from the group consisting of PTFE or polyester heat
`shrink material.” ........................................................................ 70 
`
`
`
`- iv -
`
`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 7,891,085
`X.  Nevro is unaware of any secondary considerations of non-obviousness ...... 71 
`XI.  Standing (37 C.F.R. § 42.104(a)) .................................................................. 72 
`XII.  Mandatory Notices (37 C.F.R. § 42.8) .......................................................... 72 
`A. 
`Real Party In Interest ........................................................................... 72 
`B. 
`Related Matters .................................................................................... 72 
`C. 
`Lead and Back-up Counsel ................................................................. 73 
`D. 
`Service Information ............................................................................. 74 
`CERTIFICATION OF SERVICE (37 C.F.R. §§ 42.6(e), 42.105(a)) ..................... 75 
`CERTIFICATE OF COMPLIANCE WITH TYPE-VOLUME LIMITATION,
`TYPEFACE REQUIREMENTS, AND TYPE STYLE
`REQUIREMENTS ........................................................................................ 76 
`
`
`
`
`
`- v -
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`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 7,891,085
`
`EXHIBIT LIST
`
`Exhibit No.
`
`Description
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`1014
`
`1015
`
`1016
`
`U.S. Patent No. 7,891,085 to Kuzma et al.
`
`U.S. Patent No. 7,891,085 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.
`
`U.S. Patent App. Pub. No. 2002/0143377 to Wessman et al.
`
`Modern Plastics Encyclopedia, Volume 63, Number 10A
`(October 1986)
`
`Mark Saab, Using Thin-Wall Heat-Shrink Tubing in Medical
`Device Manufacturing, Medical Device and Diagnostic Industry,
`54-62 (April 1999)
`
`WO2001/032259 to Huepenbecker et al.
`
`U.S. Patent No. 5,374,245 to Mahurkar
`
`U.S. Patent No. 4,005,168 to Whitfill et al.
`
`U.S. Patent No. 4,710,175 to Cartmell et al.
`
`U.S. Patent No. 6,473,653 to Schallhorn et al.
`
`
`
`- vi -
`
`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 7,891,085
`Petitioner Nevro Corp. requests inter partes review of claims 1-19 of U.S.
`
`Patent No. 7,891,0851 (Ex. 1001), which is assigned to Boston Scientific
`
`Neuromodulation Corporation (“BSNC”).
`
`I.
`
`Introduction
`
`The sole independent claim of the ’085 patent is directed to making an
`
`implantable lead that provides electrical stimulation therapy. In its most basic
`
`form, the lead body described in the ’085 patent has an electrode array at a distal
`
`end, and a plurality of corresponding conductive contacts at a proximal end. The
`
`distal-end electrodes stimulate the area where the lead is implanted, and the
`
`contacts at the proximal end are typically coupled to an implantable pulse
`
`generator. As applied herein, BSNC interprets this claim in the co-pending district
`
`court litigation to require a plurality of conductive wires that run the length of the
`
`lead body to couple the proximal end contacts to their corresponding distal end
`
`electrodes. The conductive wires run inside conductor lumens, which are hollow
`
`bores within the insulated lead body. Insulating spacers are disposed between
`
`individual adjacent distal-end electrodes and individual proximal-end contacts.
`
`
`1 The ’085 patent issued on February 11, 2011 and was thus filed well-prior
`
`to the enactment of the America Invents Act (“AIA”). Accordingly this petition
`
`applies the pre-AIA versions of 35 U.S.C. §§ 102, 103, 112.
`
`
`
`
` - 1 -
`
`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 7,891,085
`This basic and well-known structure is laid out in the first four steps of
`
`independent claim 1 of the ’085 patent:
`
`1. A method of manufacturing a stimulation lead having a proximal
`end and a distal end, comprising:
`[a] providing a plurality of conductive contacts located at an end of a
`lead body of the stimulation lead;
`[b] disposing a plurality of conductor wires in a plurality of conductor
`lumens formed in the lead body;
`[c] connecting at least one of the plurality of conductor wires to each
`of the conductive contacts;
`[d] placing spacers between pairs of adjacent conductive contacts, wherein
`portions of the conductor lumens are located beneath the plurality of conductive
`contacts and the spacers. Ex. 1001, 8:10-22.
`
`The last two steps of the ’085 patent, focus very narrowly on filling, at least
`
`partially, an empty portion of a conductor lumen. The specific steps in the ’085
`
`patent include inserting monofilament into at least a portion of the lumen, and then
`
`heating the spacers and the monofilaments so that at least one melts or thermally
`
`reflows into the empty space of a conductor lumen. The last two steps are
`
`reproduced below:
`
`[e] inserting monofilament into at least one portion of at least one of
`the conductor lumens of the lead body that is not occupied by the
`conductor wires; and
`[f] reflowing at least one of the spacers or monofilament into at least
`one portion of at least one of the conductor lumens not occupied by
`
`
`
`
` - 2 -
`
`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 7,891,085
`the conductive wires by heating the spacers and monofilament to a
`temperature to cause thermal flow or melting of at least one of the
`spacers or monofilament. Ex. 1001, 8:23-32.
`
`*
`
`*
`
`*
`
`By January 11, 2005 (the earliest priority date for the ’085 patent), the field
`
`of implantable leads for providing electrical stimulation to a body was already
`
`mature. Ex. 1003, ¶¶1-37. Many prior-art implantable leads at that time had the
`
`exact same basic structure as claim 1 of the ’085 patent. This is readily seen in the
`
`Stolz reference. See e.g., Ex. 1005, Stolz, FIGs. 4-5. Moreover, the benefits of
`
`filling empty portions of a conductor lumen in an implantable lead were also well-
`
`known in the prior art. Indeed, Stolz itself heats and reflows thermoplastic material
`
`from its distal tip into the empty portions of its conductor lumens. Ex. 1005,
`
`[0035], [0036], [0046]. The Ormsby reference teaches why it is beneficial to fill
`
`empty conductor lumens, see e.g., Ex. 1006, Ormsby, 7:3-10, while the Black
`
`reference teaches the specific technique of reflowing a spacer into the empty
`
`spaces of a conductor lumen, Ex. 1008, 7:13-24.
`
`Nevro will thus prove in the petition below that the BSNC’s purported
`
`invention in the ’085 patent is nothing more than an incremental and obvious
`
`modification to well-known prior art leads, and lead manufacturing techniques,
`
`available by January 2005.
`
`
`
`
` - 3 -
`
`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 7,891,085
`Statement of Unpatentability Grounds for Claims 1-19 of the ’085
`Patent
`
`II.
`
`Nevro requests inter partes review of claims 1-19 of the ’085 patent and a
`
`determination that those claims are unpatentable based on the following grounds:
`
`2
`
`Ground Prior Art
`1
`Stolz, Ormsby, Black, and
`knowledge of POSA
`Stolz, Ormbsy, Black,
`knowledge of POSA, and
`further in view of the Modern
`Plastics Encyclopedia
`Stolz, Ormbsy, Black,
`knowledge of POSA, and
`further in view of Wessman
`Stolz, Ormbsy, Black,
`knowledge of POSA,
`Wessman, and further in
`view of Saab
`
`3
`
`4
`
`Basis Claims Challenged
`§ 103
`1-3, 6-12, and 14-17
`
`§ 103
`
`§ 103
`
`§ 103
`
`4, 5, and 13 (time and
`temperature parameters for
`reflowing thermoplastic
`material)
`18 (use of heat shrink
`tubing)
`
`19 (heat shrink tubing made
`of PTFE)
`
`
`
`The earliest priority date on the face of the ’085 patent is January 11, 2005.
`
`The prior art references cited for each ground above qualify as prior art to the ’085
`
`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.
`
`
`
`
` - 4 -
`
`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 7,891,085
` 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.
` Wessman (Ex. 1009): U.S. Patent App. Pub. No. 2002/0143377 to
`Wessman et al. qualifies as prior art under 35 U.S.C. § 102(b) at least
`because its publication date is October 3, 2002, which is more than one
`year before January 11, 2005.
` 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.
` Saab (Ex. 1011): Using Thin-Wall Heat-Shrink Tubing in Medical
`Device Manufacturing, Medical Device & Diagnostic Industry Magazine
`(April 1, 1999), (available at https://www.mddionline.com/using-thin-
`wall-heat-shrink-tubing-medical-device-manufacturing) 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).
`
`
`
`
` - 5 -
`
`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 7,891,085
`
`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. On the face of the ’085 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
`
`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 ’085 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,
`
`¶¶21-24.
`
`
`
`
` - 6 -
`
`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 7,891,085
`
`IV. Claim Construction
`
`In considering the scope and meaning of the claims of an unexpired patent
`
`(such as the ’085 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 ’085 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 ’085 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 ’085 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
`
`
`
`
` - 7 -
`
`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 7,891,085
`contact attached to the elongate device, usually at the distal portion of the elongate
`
`device.” Ex. 1001, 1:31-35.
`
`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 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, such as in a U.S. District Court, that a
`
`claim of the ’085 patent is indefinite or has a claim scope that differs from its
`
`broadest reasonable interpretation.2
`
`
`2 Specifically, the ’085 patent is part of BSNC’s suit against Nevro. See
`
`Mandatory Notices, Section XII.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.
`
`
`
`
` - 8 -
`
`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 7,891,085
`Summary of the Unpatentability Argument for Independent Claim 1.
`
`V.
`
`Independent claim 1 is unpatentable under 35 U.S.C. § 103 over Stolz,
`
`Ormsby, Black, and the knowledge of a POSA. Nevro first provides a summary of
`
`its unpatentability position 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 each of the four grounds below
`
`in Sections VI-IX.
`
`Stolz (Ex. 1005) is the base reference. It discloses a stimulation lead having
`
`the same structure set forth in claim 1. Stolz is only missing the steps of (1)
`
`“inserting monofilament” into at least a portion of a conductor lumen that is
`
`unoccupied by the conductor wires, and (2) then heating the monofilament and the
`
`spacers to reflow material from either a monofilament or a spacer into those
`
`unoccupied spaces of the conductor lumen. Ormsby (Ex. 1006) provides the
`
`motivation to modify Stolz to fill the unoccupied portions of the conductor lumens.
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`Black (Ex. 1008), which was considered during prosecution of the application
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`which led to the ’085 patent, teaches the technique of heating the spacers between
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`the electrodes to reflow material into the void spaces of a conductor lumen—a
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`teaching the Examiner did not appreciate at the time.
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`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 7,891,085
`
`A. Overview of the ’085 patent
`
`The ’085 patent is generally directed to the lead portion of an implantable
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`system with a microstimulator 12 and a stimulation lead 18 having multiple
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`electrodes 17 at a distal end of the lead. Figure 1 is illustrative and shows an array
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`18 of electrodes 17 at the distal end of lead 16:
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`Ex. 1001, FIG. 1; 3:42–53, 4:6–16.
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`
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`The microstimulator 12 and stimulation lead 16 are typically implanted in a
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`body. Id., 4:6–16. In one embodiment, it provides stimulation to a spine. Id.
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` - 10 -
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`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 7,891,085
`
`
`
`Ex. 1001, FIG. 2.
`
`Figures 3A and 5A and 5B from the ’085 patent, annotated below in color,
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`show the basic structure of an implantable lead made by the claimed method:
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` - 11 -
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`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 7,891,085
`
`
`
`Ex. 1001 at FIGS. 3A, 5A, and 5B; See also Ex. 1003, ¶¶40-44.
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`The claimed stimulation lead 16 has an electrode array 18 at its distal end
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`(i.e., the end furthest from the signal generator). Ex. 1001, 4:17-51. The key
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`structural components are the conductor wires 122, the conductive contacts (i.e.,
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`electrodes) 17, and the spacers 61 placed between the conductive contacts. See id.
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`Each electrode contact 17 receives the stimulation signals from an attached
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`conductor 122 that runs through a separate conductor lumen disposed along the
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`length of the interior of the lead body. See Ex. 1003, ¶¶43-45.
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`
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` - 12 -
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`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 7,891,085
`Figures 5A and 5B of the ’085 patent show how the conductor lumens 116
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`and conductors 122 are disposed in the stimulation lead body. Ex. 1001, 5:13-56.
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`In these views, the conductors 122 run through the hollow conductor lumens 116
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`along the length of the lead body. The method of assembly set forth in the sole
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`independent claim 1 of the ’085 patent puts this basic and well-known stimulation
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`lead structure together. Ex. 1003, ¶¶40-45.
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`The ’085 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 multi-lumen tube body. Ex. 1001, 7:18-20, 7:29-31. The
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`described embodiment consists of inserting 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.
`
`
`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.”
`
`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.).
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`
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` - 13 -
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`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 7,891,085
`Figures 6A and 6B of the ’085 patent illustrate both the structure and the
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`steps of filling the void space where the conductors are coupled to an electrode
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`contact.
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`
`
`Ex. 1001 at FIGS. 6A and 6B; Ex. 1003, ¶¶55-56.
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`In the figures, monofilament 60 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
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`
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` - 14 -
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`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 7,891,085
`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,
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`and monofilament 60—is heated at 190 degrees Celsius for 30 seconds. This
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`causes the spacer 61 and/or the monofilament 60 to melt or reflow, and then to fill
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`a portion of the void space 70 near the electrode contact 17. Ex. 1001, 6:7-39, see
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`also Ex. 1003, ¶¶54-67.
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`B.
`
`The prosecution history
`
`The prosecution history is instructive. Prosecution claim 11 became
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`independent claim 1. Ex. 1002, pp. 179, 163-164. Prosecution claim 11 is set forth
`
`below, with step identifiers [a]-[g] added.
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`The primary prior art reference during prosecution of the application that led
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`to the ’085 patent was U.S. Patent No. 6,216,045 to Black et al. (Ex. 1008). Ex.
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`1002, p. 166. The patentee persistently focused on the monofilament and the step
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`of reflowing material from the monofilament or the spacers, in an attempt to get
`
`around the applied art. Id., pp. 149-150, 120-122, 92-93, 56-58.
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`After four attempts to amend and two requests for continued examination
`
`(Id., pp. 113, 63), the patentee completely changed course and amended
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`prosecution claim 11, as shown in issued claim 1 above, to add the step of
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`“disposing a plurality of conductor wires in a plurality of conductor lumens
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`formed in the lead body.” Ex. 1002, p. 52. Prior versions of prosecution claim 11
`
`
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` - 15 -
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`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 7,891,085
`did not include the structural requirement of a plurality of “conductor lumens.” Id.,
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`pp. 215, 146, 116 and 88. The patentee also added the related step that the
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`monofilament be “inserted into at least one portion of at least one of the conductor
`
`lumen.” Id., p. 52. The patentee then argued that Black did not teach the insertion
`
`of a monofilament into the unoccupied portions of those newly added conductor
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`lumens. Id., pp. 56-57. The amended claim was then allowed.
`
`C.
`
`Independent claim 1 is unpatentable ove