Trials@uspto.gov
`571-272-7822
`
`Paper No: 7
`Entered: May 17, 2018
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`NEVRO CORP.,
`Petitioner,
`
`Vv.
`
`BOSTON SCIENTIFIC NEUROMODULATION CORP.,
`Patent Owner.
`
`Case No. IPR2018-00148
`Patent No. 8,646,172 B2
`
`Before HUBERT C. LORIN, MICHAEL W.KIM,and
`AMANDAF. WIEKER,Administrative Patent Judges.
`
`LORIN,Administrative Patent Judge.
`
`DECISION
`DenyingInstitution of Inter Partes Review
`35 US.C. § 314
`
`
`571-272-7822
`
`Paper No: 7
`Entered: May 17, 2018
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`NEVRO CORP.,
`Petitioner,
`
`Vv.
`
`BOSTON SCIENTIFIC NEUROMODULATION CORP.,
`Patent Owner.
`
`Case No. IPR2018-00148
`Patent No. 8,646,172 B2
`
`Before HUBERT C. LORIN, MICHAEL W.KIM,and
`AMANDAF. WIEKER,Administrative Patent Judges.
`
`LORIN,Administrative Patent Judge.
`
`DECISION
`DenyingInstitution of Inter Partes Review
`35 US.C. § 314
`
`
`
`IPR2018-00148
`Patent 8,646,172 B2
`
`I. INTRODUCTION
`A. Background
`
`Nevro Corp. (“Petitioner”) filed a Petition requesting inter partes
`
`review of claims 1-11 of U.S. Patent No. 8,646,172 B2 (Ex. 1001, “the °172
`
`patent”) pursuant to 35 U.S.C. §§ 311-319. Paper 2 (“Pet.”). Boston
`
`Scientific Neuromodulation Corp.(‘Patent Owner’’) filed a Preliminary
`
`Response to the Petition (Paper6, “Prelim. Resp.”’).
`
`Wehave authority under 35 U.S.C. § 314.
`
`Uponconsideration of the arguments and evidence presented by
`
`Petitioner and Patent Owner, we are not persuadedthat Petitioner has
`
`demonstrated, under 35 U.S.C. § 314(a), a reasonable likelihood thatit
`
`would prevail in showing the unpatentability of any of the challenged
`claims. Accordingly, we do notinstitute an inter partes review of any claim.
`
`B. Related Proceedings
`
`Petitioner notifies us that “[t]he ’172 patent is the subject of one civil
`
`action: Boston Scientific Corporation et al. v. Nevro Corp., Case No.1:16-
`
`cv-01163 (D. Del.), filed December 9, 2016.” Pet. 66; see also Paper3, 2
`
`(indicating the same).
`
`C. The ’172 patent (Ex. 1001)
`
`1. Effective Filing Date
`Petitioner indicates that the earliest priority date of the ’172 patentis
`
`January 11, 2005. Pet. 5. This is in accord with the information recited on
`
`the cover of the ’172 patent. Ex. 1001, (60).
`
`
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`IPR2018-00148
`Patent 8,646,172 B2
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`2. Disclosure
`
`The ’172 patent, titled “Electrode Array Assembly and Methodof
`
`Making Same,” discloses manufacturing a stimulation lead related to
`implantable leads for providing electrical stimulation usedto treat a variety
`
`of maladies. Ex. 1001, (57), 1:15-24. Accordingto the patent,
`
`(iJn general, it is desirable to makethe lead efficiently, with the
`fewest number of process steps, maximize the manufacturing
`yield, and hence reduce the cost of goods of buildingthe leads.
`There is thus a continual need to improve the design of a
`percutaneous lead in order to improve its performance and to
`improve the method of manufacturingthe lead.
`Ex. 1001, 2:2-8.
`
`In one embodiment, relevant to whatis claimed, during manufacture,
`
`a void space in a part of a lead assemblyis filled with nonconductive
`material (e.g., a monofilament) and “then placed into a heat.” Ex. 1001,
`
`6:17-20.
`
`3. Claims
`
`The °172 patent has 11 claims, all of which are challenged.
`
`Independentclaim1is illustrative.
`1,
`A method of manufacturing a stimulation lead comprising:
`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 alongthe insulation section and arranged around, and
`external to, the central lumen, 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 oneofthe plurality of
`conductor lumens and each of the conductor lumens of the
`plurality of conductor lumenshas at least one of the conductor
`
`
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`IPR2018-00148
`Patent 8,646,172 B2
`
`wires of the plurality of conductor wires disposed therein,
`wherein a portion of the conductor lumensis disposed radially
`beneath the conductive contacts;
`
`after providing the lead body, conductively coupling at
`least one of the plurality of conductor wires to each of the
`conductive contacts; and
`after providing the lead body, placing non-conductive
`material into a portion ofat least one of the conductor lumens of
`the lead body, wherein at least a portion of the non-conductive
`materialis disposed radially beneath the conductive contacts.
`Claim 6 is also directed to “a method of manufacturing a stimulation
`
`lead.” Claims 1 and6parallel each other, except that claim 6 includes, after
`placing the non-conductive material into a portion ofat least one ofthe
`conductor lumensofthe lead body, heating the non-conductive material “to
`
`cause the non-conductive material to thermally reflow or melt.” Compare
`
`Ex. 1001, 8:20-44, with id. at 8:61-10:3.
`Claims 2-5 depend from claim 1, and claims 7-11 depend from claim
`
`D. Asserted References
`
`Petitioner relies on the following references:
`
`
`
`Stolz
`
`1005
`
`1006
`1008
`
`US. Patent Application Publication No.
`2003/0199950 Al, published Oct. 23, 2003
`PCT Application Publication No. WO 00/35349,
`published June 22, 2000
`Ormsby
`
`
`USS.Patent No. 6,216,045 B1, granted Apr. 10,
`Black
`2001
`
`
`
`
`Modern Plastics Encyclopedia, 1986-1987,
`Modern
`1010
`Plastics
`published by McGraw-Hill, Inc., October
`
`
`Encyclopedia|1986, Volume 63, Number 10A,pp. 3, 540
`
`
`
`
`
`
`
`
`
`
`
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`IPR2018-00148
`Patent 8,646,172 B2
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`E. Grounds Asserted
`
`Petitioner contendsthat claims 1 -11 of the ’172 patent are
`
`unpatentable under the following two grounds:
`
`
`
`
`
`
`§ 103
`
`
`
`Stolz, Ormsby, and Black
`
`6-11
`Stolz, Ormsby, Black, and
`
`Modern Plastics Encyclopedia
`
`
`
`Pet. 6.
`
`Petitioneralso relies on the Declaration of Michael Plishka (Ex. 1003)
`
`as support for the various contentions.
`
`Il. ANALYSIS
`
`A. Claim Construction
`
`This Decision requires construing the claim phrase “radially beneath.”
`This is so because a major contentionin this case is whether the cited prior
`art discloses “non-conductive material is disposed radially beneath the
`
`conductive contacts.” See Ex. 1001, claim 1 (similarly claim 6).
`The ’172 patent specification does not provide an express definition
`for “radially beneath.” The phraseis recited in the Abstract and in some of
`the claims, but is not otherwise mentioned. However,“radially” is
`commonly and ordinarily understood to mean like a radius. See Webster's
`New World Dictionary, Third College Edition, 1988, p. 1107 (defining
`RADIALas “2 ofor situated like a radius”). Given that a circle’s radius
`
`extends from the circle’s centerto its circumference, it follows that any point
`
`along a radiusthat is below, for example, the circle’s circumterenceis
`“radially beneath” the circumference. See id. (defining RADIUSas “any
`
`
`
`IPR2018-00148
`Patent 8,646,172 B2
`
`straight line extending from the center to the periphery of a circle or
`
`sphere”).
`The ’172 patent supports construing “radially beneath” as used in
`
`claims 1 and 6 consistent with this ordinary meaning.
`
`Figures 6A and 6B ofthe ’172 patent are reproduced below.
`
`CUECRNge
`
`34
`
`OMMFLMMALPAaaaA aAaaA
`
`FIG. 6A depicts “a close-up,partial, longitudinal view of[a] lead
`assembly at[a] distal portion ofthe lead; and FIG. 6B depicts how
`polyurethane monofilament[60] or a thermoplastic material is used to
`fill the voids and is incorporated into the lead by applying heat.”
`Ex. 1001, 3:32-36.
`
`
`
`IPR2018-00148
`Patent 8,646,172 B2
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`“FIG. 6A showsa ring-like electrode contact 17.” Ex. 1001, 5:65-66. This
`correspondsto “conductive contacts”(claims 1 and 6). Element 60in
`Figures 6A and 6B correspondsto “a solid, non-conductive material”
`(claims 1 and 11). Ex. 1001, 5:61-6:30. Figures 6A and 6B showthe “non-
`
`conductive material’ 60 situated below the “conductive contacts” 17, ¢.g.,
`
`between the lead’s center point and the lead’s conductive contacts, the lead’s
`conductive contacts being located near the lead’s circumference.
`Accordingly, on this record, the claim phrase “radially beneath,” in
`the claim limitation “non-conductive material is disposed radially beneath
`
`the conductive contacts” (claim 1, similarly claim 6), is reasonably
`
`construed to mean that the non-conductive materialis situated between the
`
`lead’s center point and the lead’s conductive contacts, the lead’s conductive
`contacts being located near the lead’s circumference.
`
`B. Overview ofthe Asserted Prior Art References
`
`1. Stolz
`
`Stolz indicates that “there is a need for an implantable lead with
`
`isolated contact couplings to reduce the opportunity for conductor material
`to migrate to the contactorinto the patient.” Ex. 1005 ¥ 5. Stolz
`accomplishes this by providing “[a]n implantable lead with an isolated
`contact connection for connecting a conductorto a contact.” Ex. 1005 { 6.
`
`2. Ormsby
`Ormsby relates to guidewires with imagingcapabilities for use in
`
`over-the-wire catheters. Ex. 1006, 1:3-17.
`
`
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`IPR2018-00148
`Patent 8,646,172 B2
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`3. Black
`
`Black discloses an implantable lead having spacers in between
`
`adjacent electrodes and terminals. Ex. 1008, 6:19-36.
`
`4. Modern Plastics Encyclopedia
`Modern Plastics Encyclopedia discloses a table of properties for
`
`polystyrene and styrene coploymers and polyurethane. Ex. 1010, 540.
`
`C. Ground I
`
`Petitioner challenges claims 1—5 as obvious under 35 U.S.C. § 103(a)
`
`over Stolz, Ormsby, and Black. Pet. 28-52.
`
`Claim 1
`
`Petitioner contends that claim 1 of the ’172 patent is unpatentable
`
`under § 103 over Stolz, Ormsby, and Black.
`The issue is whether it would have been obviousto one of ordinary
`
`skill in the art, at the time of the invention, to “plac[e] non-conductive
`material into a portion ofat least one of . .. conductor lumensof[a] lead
`body, whereinat least a portion of the non-conductive material is disposed
`radially beneath the conductive contacts” (claim 1) over the combined
`disclosures of Stolz, Ormsby, and Black.
`
`“radially beneath”
`Petitioner argues that Stolz discloses disposing a non-conductive
`material radially beneath conductive contacts. Pet. 39.
`
`
`
`IPR2018-00148
`Patent 8,646,172 B2
`
`Stolz discloses that the isolation space 506 can include a
`“fill material” (such as epoxy)—which a POSA would have
`understood to be nonconductive Ex. 1003, §§134—137—further
`filling an unoccupied portion of the conductor lumen that is
`radially beneath the conductive contacts.
`Jd. [0046]. Stolz’s
`FIG. 13 annotated below showtheisolation space 506is radially
`beneath Stolz’s conductive contacts.
`
`Id. at 39.
`
`Petitioner provides annotated and color-coded versions of Figures 12
`
`and 13 of Stolz, which are reproduced below. Jd. at 39.
`
`32
`
`40
`
`GEE Specer «6
`BE Contec: 36
`HEE (220 d00y 32
`GE conctuctor3s
`[CJ] conductorLumen 102
`
`BEEBE conctector Couping soarsv2
`
`102
`
`FIG. 13
`
`Petitioner’s annotated and color-coded versions of
`Figures 12 and 13 of Stolz.
`Thus, Petitioner contends that Stolz discloses “non-conductive
`material is disposedradially beneath the conductive contacts.” Pet. 39.
`Patent Ownerdisagrees, arguingthat:
`Stolz discloses the use of a non-conductive epoxy material in a
`specific location:
`the isolation space contained within the
`coupling element used to prevent conductor material
`from
`
`
`
`IPR2018-00148
`Patent 8,646,172 B2
`
`(Ex. 1005 at § 46 (“The isolation space
`entering the weld pool.
`506 separates the conductor 34 from the weld 504 to substantially
`prevent the conductor 34 from contacting the weld 504....In
`some embodiments, the isolation space can includea fill material
`such as epoxy.”).) As can be seen in Figures 13 and 14[, which
`are reproduced below,] the epoxy is restricted to a small portion
`of the coupling member(112) and the void space (506).
`
`502
`
`102
`
`FIG. 13
`
`598
`
`112
`
`FIG. 14
`
`Stolz discloses that the isolation space (506) is formed by the geometry
`of the coupling element (112), which is then placed into a notch on
`Stolz’s conductive contacts. Thus, the epoxy in Stolz’s void spacesis
`surrounded by the conductive material of the coupling element (112)
`and is disposed radially beneath that coupling element rather than
`underneath the conductive contact itself.
`
`Prelim. Resp. 24.
`It is not disputed that Stoltz discloses an isolation space (element 506
`in Stolz, FIGS. 13-14, supra) and that the space “can include a fill material
`such as epoxy” (Ex. 1005 4 46). Noris there any dispute that epoxy is a
`non-conductive material. The dispute is over whether the epoxy, whenit
`fills the isolation space 506,is “radially bencath” the conductive contact 36.
`Figure 13 showsisolation space 506 having a geometry suchthat, if it
`“include[d] a fill material such as epoxy” (Ex. 1005 § 46), the fill material
`
`10
`
`
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`IPR2018-00148
`Patent 8,646,172 B2
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`would fill the space not only directly under the weld (504), but also slightly
`
`to the left just under the conductive contact (36). If the fill material is
`epoxy, the epoxy would become disposed between the lead’s center point
`
`and the conductive contacts.
`
`Accordingly, via Figure 13, Stolz discloses sufficiently a non-
`conductive material“radially beneath” the conductive contacts, as that claim
`
`phrase is reasonably broadly construed. See supra Section ILA.
`
`“into a portion ofat least one ofthe conductor lumens”
`However, Figure 13 of Stolz does not show “placing non-conductive
`material into a portion ofat least one of... conductor lumens of[a] lead
`body, whereinat least a portion of the non-conductive material is disposed
`radially beneath the conductive contacts” (claim 1).
`In Figure 13, the “isolation space 506 is created between the
`conductor 34 and the contact 36 to prevent directly welding the conductor 34
`to the contact 36. The isolation space 506 separates the conductor 34 from
`the weld 504to substantially prevent the conductor 34 from contacting the
`weld 504.” Ex. 1005 946. “The coupling 112 has a conductor coupling 500
`and a contact coupling 502.” Ex. 1005 945. “The conductor coupling 500
`is placed over the conductor 34 and attached to the conductor 34
`mechanically. The contact coupling 502 exits the lead body and has a weld
`504 to connect the contact coupling 502 to the contact 36.” Ex. 1005 45.
`AsPetitioner illustrates (via annotated and color-coded FIG. 13, supra),
`coupling 112 formsa barrier that prevents lumen 102 from communicating
`with isolation space 506. Coupling 112, therefore, surrounds isolation space
`
`506.
`
`11
`
`
`
`IPR2018-00148
`Patent 8,646,172 B2
`
`Thus, although Stolz discloses that isolation space 506 within
`coupling 112 could befilled with a non-conductive material, and which,
`uponbeingfilled, would appear to dispose the non-conductive material
`“radially beneath” the conductive contacts, Stolz discloses placing the
`
`nonconductive material into coupling 112, not into a portion of the
`
`conductor lumen 102. Accordingly, Stolz FIG. 13 does not disclose
`“placing non-conductive material into a portionofat least one ofthe
`conductor lumens of [a] lead body”(claim 1), notwithstandingat least a
`portion of Stolz’s non-conductive material is disposed radially beneath the
`
`conductive contacts.
`
`Petitioner relies on Stolz, Ormsby, and Black as evidencethat it
`
`would have been obviousto place non-conductive material in a conductor
`
`lumen.
`
`Regarding Stolz, Petitioner argues, inter alia, that
`Stolz... fills, at least in part, an unoccupied portion ofat least
`one of the conductor lumens. In the described embodiment,“the
`formed distal tip 300 seals the conductor lumens 102 free from
`adhesive or solvents.” [Ex. 1005, 0035]. This is accomplished
`when“[t]he heat conducted from the mold to the lead distal tip
`300 melts the surrounding material into the conductor lumen 102
`and into the stylet lumen 100, completely sealing them from the
`outside.” Jd., [0036]. The solid distal tip 300 thus “penetrates
`the lumens 100, 102 of the lead body... [and] reaches no further
`into the lumens than making contact to the enclosed conductors.”
`Id., [0035]. This material may be a wide range ofelectrically
`isolative (i.e., nonconductive) materials and configurations such
`as silicone rubber, polyurethane, fluoropolymers andthelike.
`Pet. 38.
`
`However, Petitioner acknowledgesthat “Stolz’s sealing the end ofthe
`implantable lead with its distal tip does have somepotential
`
`12
`
`
`
`IPR2018-00148
`Patent 8,646,172 B2
`
`disadvantages. Specifically, the reflowed portion of Stolz’s distal tip may
`
`not penetrate very far into the stylet lumen or the conductor lumens.”
`
`Pet. 40 (citation omitted). Petitioner contends that “some conductor lumens
`
`... maystill have a long, unoccupied space betweenthe distal tip and the
`
`conductor.” Id.
`
`Petitioner argues that
`
`[b]y January 2005, however, a POSA would have
`recognized that leaving long, empty portions of a conductor
`lumen could be an undesirable condition, depending on the
`application. Ex. 1003, J 142. For example, as Nevro’s expert
`explains, a long and empty conductor lumen would be more
`susceptible to perforation, kinking, or other material damage,
`such as during insertion into a human body. Further, having
`empty conductor
`lumens of varying lengths could cause
`variations in the flexibility of the implantable lead. Jd. Finally,
`empty conductor lumenscould increase the chance of separation
`of components of the lead body from one another. Id.
`To prevent
`these potential problems, a POSA would
`therefore have searched for other known techniquesforfilling
`the unoccupied portions of the conductor lumens. Andto doso,
`a POSA would have thus considered other medical devicc
`references to identify suitable methods for filling lumens and
`other spaces within elongate structures having conductive wires
`therein.
`Pet. 40-41. Petitioner cites Ormsby and Black as two such medical device
`
`references.
`
`Relying on Figure 3 of Ormsby,Petitioner argues that Ormsby shows
`filling lumen 29 with filler 81, which can beliquid epoxy,“[i]n order to
`substantially increase the kink resistance of the flexible elongate tubular
`
`member26.” Pet. 42 (quoting Ex. 1006, 7:3-5).
`An annotated version of Figure 3 of Ormsbyis reproduced below.
`
`13
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`
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`IPR2018-00148
`Patent 8,646,172 B2
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`8
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`
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`Ormsby FIG. 3 depicts “an enlarged cross-sectional view ofthe distal
`extremity of the guidewire.” Ex. 1006,2.
`
`Figure 3 shows flexible elongate tubular member 26, of a guidewire for a
`catheter, with lumen 29. Ex. 1006, 7:4. Fill material 81 is located in lumen
`
`29. Id. at 4—S, 8-9.
`Relying on Figure 3 of Black,Petitioner argues that “Black also
`disclosesfilling the unoccupied portion of a conductor lumen,andalso the
`space beneath its conductive contacts, and it provides a different technique
`for doing so. See Ex. 1002 J9152-157.” Pet. 42-43.
`
`Figure 3 of Black is reproduced below.
`
`
`
`Black FIG. 3 depicts a sectional view of an implantablelead.
`Ex. 1008, 3:6—7.
`
`14
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`IPR2018-00148
`Patent 8,646,172 B2
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`According to Petitioner,
`
`[t]he conductors 20 are disposed around a center stylet
`100, and stylet tubing 24. Ex. 1008, 5:28-45, 6:5-10, 7:12-23.
`The conductor lumen is the cylindrical (toroidal- or donut-
`shaped) space betweenthestylet tubing 24 and the outer tubing
`22, 23 in which the conductors 20 are disposed. There are spaces
`between the conductorsat this stage of manufacture.
`
`Pet. 42. Petitioner argues that Black
`
`then reflowing non-
`the technique of heating,
`discloses
`conductive lead elements, like its spacers,to fill its empty space
`in the conductor lumen, and beneath the conductive contacts. See
`Ex.
`1008 5:28-45, 6:5-10, 7:12-23. Specifically, Black
`discloses that “electrode spacers 28 and terminal spacers 30 are
`placedin a state of flow, which,at least in part, results in afilling
`of regions between terminals 16/electrodes 18 and stylet guide
`24”—.e., unoccupied portions or spaces in the conductor lumen.
`Ex. 1008, 7:13—16 (emphasis added).
`
`Pet. 43-44.
`
`Black describes a manufacture whereby a “completed assembly
`
`(FIG. 5 [reproduced below]) is then over-molded.” Ex. 1008, 7:5.
`
`
`
`FIG.5 is a plan view of an assembly of elements on a mandrel [150] used to
`form a lead in accordance with Black’s invention.
`
`Black’s manufacture process comprises positioning stylet tubing 24
`over mandrel 150 and arranging and securing conductors 20 relative to stylet
`24 (id. at 5:1-12) by resting the conductors 20 “against the outer diameter of
`stylet tubing 24”(id. at 5:49—50).
`
`15
`
`
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`IPR2018-00148
`Patent 8,646,172 B2
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`tubing 24,
`Once all conductors 20 are secured to stylet
`transitional element 26, electrode(s) 18, electrode spacer(s) 28,
`outer tubing 23, terminal spacer(s) 30, terminal(s) 16, and stylet
`guide 32 are positioned over, and concentrically arranged with,
`stylet tubing24.
`
`Id. at 6:5-9. “Functionally, electrode spacer 28 and terminal spacer 30
`
`accurately defines a space between adjacent electrodes 18 and terminals 16,
`respectively.” Jd. at 6:21-23. The spacers are formed ofaninsulative
`material (id. at 7:55—66, claim 1), such as a polyurethane material (id. at
`6:33). “Outer tubing 23 separates electrodes 18 from terminals 16.” Jd. at
`
`6:37-38.
`
`“Following the assembly of each of the elements described above,
`terminals 16 and electrodes 18 are joined to their respective conductors 20.”
`
`Id. at 6:56—-58.
`
`Generally, each terminal 16 (and eachelectrode 18) is positioned
`relative to exposed conductive material 20a and 20b of a
`conductor 20 and is joined in a mannerthat facilitates a transfer
`of electrical energy, for example, resistance weld or laser weld.
`
`Id. at 6:58-62. Then the completed assembly is over-molded. Jd. at 7:5—9.
`[E]lectrode spacers 28 and terminal spacers 30 are placed in a
`state of flow, which, at least in part, results in afilling ofregions
`between terminals 16/electrodes 18 and stylet guide 24.
`Consequently,
`terminals 16 and electrodes 18 are partially
`surrounded(i.e., along an interior surface) and supported by a
`fused matrix of material.
`
`Id. at 7:13-18 (emphasis added).
`Black’s overmolding process uses “well known injection molding
`techniques.” Jd. at 7:6. The materials used for over-molding andfor the
`outer tubing 23, electrode spacer 28, and terminal spacer 30 have “the
`beneficial effect of unitizing the element assembly to form lead 10.” Jd. at
`
`16
`
`
`
`TPR2018-00148
`Patent 8,646,172 B2
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`7:6-2. Over-molding the outer tubing 23, electrode spacer 28, and terminal
`
`spacer 30 may cause materialto travel into gaps or spaces between outer
`tubing 23, electrode spacer 28, and terminal spacer 30 and conductors 20.
`
`“into a portion ofat least one ofthe conductor lumens” and
`“radially beneath”
`
`Stolz disclosesfilling a portion of at least one of the conductor lumens
`
`with a non-conductive material. Stolz also discloses sufficiently a non-
`
`conductive material “radially beneath” the conductive contacts, as that claim
`
`phrase is reasonably broadly construed. See supra Section II.A. However,
`Stolz does not disclose “placing [the] non-conductive material into a portion
`of at least one of the conductor lumens. .. , wherein at least a portion of the
`non-conductive material is disposed radially beneath the conductive
`
`contacts” (claim 1).
`Although Ormsbydiscloses “placing[filler material 81] into a portion
`of at least one of . .. conductor lumensof[a] lead body”(claim 1), it does
`
`not further disclose that “at least a portion of[filler material 81] is disposed
`
`. conductive contacts” (claim 1).
`.
`radially beneath .
`And,although Black suggests filling spaces within elongate structures
`with non-conductive material, Black does not further disclose filling spaces
`
`radially beneath conductive contacts.
`Petitioner states that “Black teaches complete filling of its conductor
`lumenspace .
`.
`. beneath its conductive contacts.” Pet. 44, citing “729-33.”
`The passage at 7:29-33 of Black reads:
`Pursuantto the described over-molding and grindingofthe entire
`lead assembly, an isodiametric lead is obtained, whichis further
`free of any gaps or voids between insulative material and
`
`17
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`IPR2018-00148
`Patent 8,646,172 B2
`
`conductive material that may otherwise exist in conventional
`devices.
`
`This passage does notdescribe filling a conductor lumen space beneath
`
`conductive contacts.
`
`Black’s over-molding processuses “well knowninjection molding
`techniques.” Jd. at 7:6. The materials used for over-molding andforthe
`outer tubing 23, electrode spacer 28, and terminal spacer 30 have “the
`beneficial effect of unitizing the element assembly to form lead 10.” Jd.at
`
`7:6-12. The reasonable effect of over-molding the outer tubing 23,
`electrode spacer 28, and terminal spacer 30 to unitize the assembly is that
`some material would travel into gaps or spaces between outer tubing 23,
`electrode spacer 28, and terminal spacer 30 and conductors 20. Butthereis
`insufficient evidence that there is a “completefilling of its conductor lumen
`space beneath its conductive contacts,” as argued (Pet. 44).
`Following the statementthat “Black teaches complete filling ofits
`conductor lumen space beneath its conductive contacts”(Pet. 44), Petitioner
`adds that “Black uses spacers 28 that are disposed between electrodes 18.”
`Id. But all that Black discloses is that regions between terminals
`16/electrodes 18 and stylet guide 24 are filled. See Ex. 1006, 7:13-18,
`supra. Thereis no disclosure that, upon over-molding, the spacer material
`fills a conductor lumen space beneath the conductive contacts.
`Petitioner provides no explanation as to how oneofordinary skill in
`the art, given Stolz, Ormsby, and Black, would have been led to place
`nonconductive material in a lumen wherein a portion of said non-conductive
`material is “radially beneath” conductive contacts, as claimed.
`Weare unpersuaded thatthe fact of disposing a non-conductive
`material “radially beneath” the conductive contacts in a coupling(i.e., Stolz)
`
`18
`
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`TPR2018-00148
`Patent 8,646,172 B2
`
`and placingit in an elongatedstructure (i.e., Stolz, Ormsby, and Black) were
`
`knownat the time of the inventionis, in and of itself, a sufficient reason to
`
`render obvious the claimed method comprising placing non-conductive
`
`material into a conductor lumens wherein a portion ofsaid materialis
`
`radially beneath the conductive contacts, as claimed.
`For the above reasons, we are unpersuadedthat the Petition
`
`establishes a reasonablelikelihood that claim 1 is unpatentable overStolz,
`
`Ormsby, and Black.
`
`Claims 2-5
`
`Claims 2—5 each depend from claim 1 and,therefore,also include the
`aforementioned limitation of placing non-conductive material into a
`conductor lumens wherein a portion ofsaid materialis radially beneath the
`conductive contacts, as set forth in claim 1. Petitioner’s position that the
`combination of Stolz, Ormsby, and Black disclosessaid limitation, or thatit
`
`would have been obvious, also applies to claims 2-5. Pet. 46-52.
`
`For the same reasons as set forth above, we are unpersuadedthat
`
`Petitioner has shownsufficiently that, one of ordinary skill in the art would
`have foundit obvious to place non-conductive material into a portionofat
`least one of a conductor lumensof a lead body, whereinatleast a portion of
`
`the non-conductive material is disposed radially beneath the conductive
`contacts, as claimed. As such, we are unpersuadedthat the Petition
`establishes a reasonable likelihood that claims 2-5 are unpatentable over
`
`Stolz, Ormsby, and Black.
`
`19
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`IPR2018-00148
`Patent 8,646,172 B2
`
`D. Ground II
`
`Petitioner challenges claims 6-11 as obvious under 35 U.S.C.
`§ 103(a) over Stolz, Ormsby, Black, and Modern Plastics. Pet. 52-65.
`
`Claim 6
`
`Petitioner contendsthat claim 6 of the ’172 patent is unpatentable
`under § 103 over Stolz, Ormsby, Black, and ModernPlastics Encyclopedia.
`Like independent claim 1, independent claim 6 requires “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 materialis
`disposed radially beneath the conductive contacts” (claim 6).' Petitioner
`takes the same position as that taken with respect to claim |. Pet. 37, 57.
`For the same reasons, therefore, as set forth above for the
`correspondinglimitation of independent claim 1, the Petition does not
`establish a reasonable likelihood that claim 6 is unpatentable overStolz,
`
`Ormsby, Black, and Modern Plastics Encyclopedia.
`
`Claims 7-11
`
`Claims 7-11 each depend from claim 6 and,therefore, also include
`the aforementionedlimitation of placing non-conductive material into a
`conductor lumens whereinaportion of said material is radially beneath the
`
`' Claim 6 includes, after placing the non-conductive material into a portion
`of at least one of the conductor lumensofthe lead body, “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 secondsto cause the non-
`conductive material to thermally reflow or melt.” ModernPlastics
`Encyclopediais cited to address this limitation. Pet. 54, 60.
`
`20
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`IPR2018-00148
`Patent 8,646,172 B2
`
`conductive contacts, as set forth in claim 6. Petitioner’s position that the
`
`combination of Stolz, Ormsby, and Black disclosessaid limitation,or thatit
`
`would have been obvious, also applies to claims 7-11. Pet. 61-65.
`
`For the same reasonsas set forth above, we are unpersuadedthat
`
`Petitioner has shownsufficiently that, one of ordinary skill in the art would
`have found it obvious to place non-conductive material into a portionofat
`least one of a conductor lumensof a lead body, wherein at least a portion of
`
`the non-conductive material is disposed radially beneath the conductive
`contacts, as claimed. As such, we are unpersuadedthat the Petition
`
`establishes a reasonable likelihood that claims 7-11 are unpatentable over
`
`Stolz, Ormsby, Black, and Modern Plastics Encyclopedia.
`
`II. CONCLUSION
`
`Forthe foregoing reasons, we determinethat Petitioner has not
`demonstrated a reasonable likelihood that it would prevail with respect to the
`claims challenged in the Petition. We do notinstitute an inter partes review
`
`of claims 1-11 of the ’172 patent.
`
`IV. ORDER
`
`It is
`
`ORDEREDthatthe Petition is denied, and that we do notinstitute an
`
`inter partes review of claims 1—11 of the 172 patent.
`
`21
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`IPR2018-00148
`Patent 8,646,172 B2
`
`PETITIONER:
`
`Jon E. Wright
`Richard D. CollerITI
`Nirav Desai
`Ian Soule
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.,
`jwright-PTAB@skgf.com
`rcoller-PTAB@skgf.com
`ndesai-PTAB@skgf.com
`isoule-PTAB@skgf.com
`
`Ching-Lee Fukuda
`Benjamin H. Huh
`SIDLEY AUSTIN LLP
`clfukuda@sidley.com
`bhuh@sidley.com
`
`PATENT OWNER:
`
`David A. Caine
`Wallace Wu
`ARNOLD & PORTER KAYE SCHOLER LLP
`David.Caine@apks.com
`Wallace. Wu@apks.com
`
`22
`
`
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