throbber
Trials@uspto.gov
`571-272-7822
`
`
`
`
`
`Paper No: 7
`Entered: May 3, 2018
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`NEVRO CORP.,
`Petitioner,
`
`v.
`
`BOSTON SCIENTIFIC NEUROMODULATION CORP.,
`Patent Owner.
`__________
`
`Case No. IPR2018-00147
`Patent No. 8,650,747 B2
`___________
`
`
`Before HUBERT C. LORIN, MICHAEL W. KIM, and
`AMANDA F. WIEKER, Administrative Patent Judges.
`
`LORIN, Administrative Patent Judge.
`
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`
`

`

`IPR2018-00147
`Patent 8,650,747 B2
`
`
`I. INTRODUCTION
`A. Background
`
`Nevro Corp. (“Petitioner”) filed a Petition requesting inter partes
`
`review of claims 1–19 of U.S. Patent No. 8,650,747 B2 (Ex. 1001, “the ’747
`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 (Paper 6, “Prelim. Resp.”).
`
`We have authority under 35 U.S.C. § 314.
`
`Upon consideration of the arguments and evidence presented by
`Petitioner and Patent Owner, we are not persuaded that Petitioner has
`demonstrated, under 35 U.S.C. § 314(a), a reasonable likelihood that it
`would prevail in showing the unpatentability of any of the challenged
`claims. Accordingly, we do not institute an inter partes review of any claim.
`
`
`B. Related Proceedings
`Petitioner notifies us that “[t]he ’747 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. 62; see also Paper 4, 2
`(indicating the same).
`
`
`C. The ’747 patent (Ex. 1001)
`1. Effective Filing Date
`
`Petitioner indicates that the earliest priority date of the ’747 patent is
`January 11, 2005. Pet. 5. This is in accord with the information recited on
`the cover of the ’747 patent. Ex. 1001, (60).
`
`
`2
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`

`IPR2018-00147
`Patent 8,650,747 B2
`
`2. Disclosure
`
`The ’747 patent, titled “Electrode Array Assembly and Method of
`Making Same,” discloses a “stimulation lead assembly for making a lead”
`related to implantable leads for providing electrical stimulation used to treat
`a variety of maladies. Ex. 1001, (57), 1:14–22. According to the patent,
`[i]n general, it is desirable to make the lead efficiently, with the
`fewest number of process steps, maximize the manufacturing
`yield, and hence reduce the cost of goods of building the leads.
`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 manufacturing the lead.
`Ex. 1001, 1:67–2:6.
`
`In one embodiment, relevant to what is claimed, during manufacture,
`a void space in a part of a lead assembly is filled with nonconductive
`material (e.g., a monofilament) and “then placed into a heat.” Ex. 1001,
`6:11–17.
`
`3. Claims
`
`The ’747 patent has 19 claims, all of which are challenged.
`
`Independent claim 1 is illustrative.
`1.
`A stimulation lead assembly for making a lead, the
`assembly comprising:
`
`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;
`
`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;
`
`3
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`

`

`IPR2018-00147
`Patent 8,650,747 B2
`
`
`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; and
`
`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;
`
`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 nonconductive material to
`thermally reflow or melt.
`Claim 11 is also directed to “[a] stimulation lead assembly for making
`
`a lead.” Claims 1 and 11 parallel each other, except that claim 11 is broader;
`for instance, while claim 11 calls for “a solid, non-conductive material
`disposed . . . within portions of the conductor lumens not occupied by
`conductor wire,” claim 1 further requires “the unoccupied portion extending
`from an end of the conductor lumen.” Compare Ex. 1001, 8:21–46, with id.
`at 9:4–21.
`
`Claims 2–10 depend from claim 1, and claims 12–19 depend from
`claim 11.
`
`
`D. Asserted References
`Petitioner relies on the following references:
`
`
`
`
`Name
`
`Stolz
`
`Reference
`U.S. Patent Application Publication No.
`2003/0199950 A1, published Oct. 23, 2003
`
`Ex. No.
`
`1005
`
`4
`
`

`

`IPR2018-00147
`Patent 8,650,747 B2
`
`
`Ormsby
`
`Black
`
`
`
`PCT Application Publication No. WO 00/35349,
`published June 22, 2000
`U.S. Patent No. 6,216,045 B1, granted Apr. 10,
`2001
`
`1006
`
`1008
`
`E. Grounds Asserted
`Petitioner contends that claims 1–19 of the ’747 patent are
`
`unpatentable under the following ground:
`
`
`Claims
`
`1–19
`
`Prior Art
`Stolz, Ormsby, and Black
`
`Basis
`§ 103
`Pet. 5.
`
`Petitioner also relies on the Declaration of Michael Plishka (Ex. 1003)
`as support for the various contentions.
`
`
`II. ANALYSIS
`A. Claim Construction
`This Decision requires construing the claim phrase “radially
`
`underneath.” This is so because a major contention in this case is whether
`the cited prior art discloses “a solid, non-conductive material disposed, at
`least in part, radially underneath the conductive contacts.” See Ex. 1001,
`claim 1 (similarly claim 11).
`
`The ’747 patent specification does not provide an express definition
`for “radially underneath.” The phrase is 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
`RADIAL as “2 of or situated like a radius”). Given that a circle’s radius
`
`5
`
`

`

`IPR2018-00147
`Patent 8,650,747 B2
`
`extends from the circle’s center to its circumference, it follows that any point
`along a radius that is below, for example, the circle’s circumference is
`“radially underneath” the circumference. See id. (defining RADIUS as “any
`straight line extending from the center to the periphery of a circle or
`sphere”).
`
`The ’747 patent supports construing “radially underneath” as used in
`claims 1 and 11 consistent with this ordinary meaning.
`
`Figures 6A and 6B of the ’747 patent are reproduced below.
`
`6
`
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`

`

`IPR2018-00147
`Patent 8,650,747 B2
`
`
`FIG. 6A depicts “a close-up, partial, longitudinal view of [a] lead
`assembly at [a] distal portion of the 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, 3:30–34.
`“FIG. 6A shows a ring-like electrode contact 17.” Ex. 1001, 5:63–64. This
`corresponds to “conductive contacts” (claims 1 and 11). Element 60 in
`Figures 6A and 6B corresponds to “a solid, non-conductive material”
`(claims 1 and 11). Ex. 1001, 5:61–6:30. Figures 6A and 6B show the
`“solid, non-conductive material” 60 situated below the “conductive
`contacts” 17, e.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 underneath,” in
`the claim limitations “a solid, non-conductive material disposed, at least in
`part, radially underneath the conductive contacts” (claim 1, similarly claim
`11), is reasonably construed to mean that the non-conductive material is
`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 of the 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 contact or into the patient.” Ex. 1005 ¶ 5. Stolz
`accomplishes this by providing “[a]n implantable lead with an isolated
`
`7
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`

`IPR2018-00147
`Patent 8,650,747 B2
`
`contact connection for connecting a conductor to a contact.” Ex. 1005 ¶ 6.
`
`2. Ormsby
`
`Ormsby relates to guidewires with imaging capabilities for use in
`over-the-wire catheters. Ex. 1006, 1:3–17.
`
`3. Black
`
`Black discloses an implantable lead having spacers in between
`adjacent electrodes and terminals. Ex. 1008, 6:19–36.
`
`
`C. Ground I
`Petitioner challenges claims 1–19 as obvious under 35 U.S.C.
`
`§ 103(a) over Stolz, Ormsby, and Black. Pet. 16–55.
`
`Claim 1
`
`Petitioner contends that claim 1 of the ’747 patent is unpatentable
`under § 103 over Stolz, Ormsby, and Black.
`
`The issue is whether it would have been obvious to one of ordinary
`skill in the art, at the time of the invention, to provide “a solid, non-
`conductive material disposed, at least in part, radially underneath [ ]
`conductive contacts and filling [an] unoccupied portion of at least one [ ]
`conductor lumen[ ]” (claim 1), “wherein each conductor lumen comprises an
`occupied portion within which at least one [ ] conductor wire[ ] 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”
`(claim 1) over the combined disclosures of Stolz, Ormsby, and Black.
`
`8
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`

`IPR2018-00147
`Patent 8,650,747 B2
`
`
`
`“radially underneath”
`Petitioner argues that Stolz discloses disposing a solid, non-
`
`conductive material, at least in part, radially underneath conductive
`contacts. Pet. 36–38.
`
`Stolz discloses that the isolation space 506 can include a
`“fill material” (such as epoxy)—which a POSA would have
`understood to be nonconductive— further filling an unoccupied
`portion of the conductor lumen that is radially underneath the
`conductive contacts. Id. [0046]. Stolz’s FIG. 13 show the
`isolation space 506 is radially underneath Stolz’s conductive
`contacts.
`Id. at 37.
`Petitioner provides annotated and color-coded versions of Figures 12
`and 13 of Stolz, which are reproduced below. Id. at 38.
`
`Petitioner’s annotated and color-coded versions of
`Figures 12 and 13 of Stolz.
`
`
`
`9
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`

`IPR2018-00147
`Patent 8,650,747 B2
`
`Thus, Petitioner contends that Stolz discloses “a solid, non-conductive
`
`material disposed, at least in part, radially underneath the conductive
`contacts.” Pet. 38.
`
`Patent Owner disagrees, arguing that
`
`the isolation space (506) is not “radially beneath” the
`conductive contacts; it is below the weld (504) and the contact
`coupling portion of the coupling element (502). (Id. ¶ 47, figs.
`14, 15 (“[T]he isolation space 506 is provided by the specific
`geometry of the contact coupling 502 and more specifically the
`non-welded material between the conductor 34 and the weld 504
`to the contact 36.”); accord id. Fig. 7.) This arrangement can be
`seen clearly in Figures 14 and 15[, which are reproduced below]:
`
`
`Further, the structure of the coupling element and the
`
`conductive contacts shows that the isolation space is not “radially
`underneath” the conductive contacts. As shown in Figure 14,
`Stolz’s conductive contacts have a slot so that the coupling
`element (112), which contains the isolation space (506), can be
`slid into that slot, and the weld (508) can be made at the edge of
`the slot so that it does not accidently draw in material from the
`conductor, which is crimped into place in the circular hole
`running through the coupling element. Because the isolation
`space is below the contact coupling portion rather than the
`conductive contact,
`the
`isolation space
`is not “radially
`underneath” the conductive contacts.
`
`10
`
`

`

`IPR2018-00147
`Patent 8,650,747 B2
`
`Prelim. Resp. 25–26.
`
`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 ¶ 46). Nor is there any dispute that epoxy is a
`non-conductive material. The dispute is over whether the epoxy, when it
`fills the isolation space 506, is “radially underneath” the conductive contact
`36.
`Figure 13 shows isolation space 506 having a geometry such that, if it
`
`“include[d] a fill material such as epoxy” (Ex. 1005 ¶ 46), the fill material
`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 underneath” the conductive contacts, as that
`claim phrase is reasonably broadly construed. See Section II.A. above.
`
`However, Figure 13 of Stolz does not show the “solid, non-conductive
`material . . . filling [an] unoccupied portion of at least one [ ] conductor
`lumen[ ]” (claim 1), the unoccupied portion being that “in which none of the
`conductor wires is disposed, the unoccupied portion extending from an end
`of the conductor lumen” (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 504 to substantially prevent the conductor 34 from contacting the
`weld 504.” Ex. 1005 ¶ 46. “The coupling 112 has a conductor coupling 500
`
`11
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`

`

`IPR2018-00147
`Patent 8,650,747 B2
`
`and a contact coupling 502.” Ex. 1005 ¶ 45. “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.
`As Petitioner illustrates (via annotated and color-coded FIG. 13, supra),
`coupling 112 forms a barrier that prevents lumen 102 from communicating
`with isolation space 506. Coupling 112 therefore surrounds the isolation
`space.
`
`Thus, although Stolz discloses isolation space 506 within coupling
`112 could be filled with a non-conductive material and which, upon being
`filled, would appear to dispose a non-conductive material “radially
`underneath” the conductive contacts, Stolz does not disclose filling an
`“unoccupied portion” of the conductor lumen, as claimed.1
`
`“unoccupied portion of at least one of the conductor lumen[]”
`
`Petitioner relies on Stolz, Ormsby, and Black as evidence that it
`
`would have been obvious to fill an unoccupied portion of a conductor lumen.
`
`Regarding Stolz, Petitioner argues, inter alia, that Stolz discloses
`heating a distal tip 300 so that it
`[“]melts the surrounding material into the conductor lumen 102
`and into the stylet lumen 100, completely sealing them from the
`outside.” [Ex. 1005 ¶ 33.] The solid distal tip 300 thus
`“penetrates the lumens 100, 102 of the lead body . . . [and]
`
`
`1 Petitioner admits that “Stolz’s disclosure of filling the isolation space with
`filling material (e.g., epoxy) [ ] may not be sufficient to expressly teach the
`feature of ‘filling the unoccupied portion of at least one of the conductor
`lumens.’” Pet. 39.
`
`12
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`

`

`IPR2018-00147
`Patent 8,650,747 B2
`
`
`reaches no further into the lumens than making contact to the
`enclosed conductors.” Id., [¶ 35].
`Pet. 36. According to Petitioner, Stolz thereby “discloses solid, non-
`conductive [material] disposed in a conductor lumen 102, e.g., to seal it . . .
`[and] thus fills, at least in part, an unoccupied portion of at least one of the
`conductor lumens.” Pet. 36.
`
`However, Petitioner acknowledges that “Stolz’s sealing the end of the
`implantable lead with its distal tip does have some potential
`disadvantages. . . . Specifically, the reflowed portion of Stolz’s distal tip
`may not penetrate very far into the stylet lumen or the conductor lumens.”
`Pet. 38. Petitioner contends that
`some conductor lumens . . . may still have a long, unoccupied
`space between the distal tip and the conductor . . . [and therefore
`the disclosure of heating the distal tip to seal the conductor
`lumens] may not be sufficient to expressly teach the feature of
`“filling the unoccupied portion of at least one of the conductor
`lumens.”
` Pet. 39.
`
`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, ¶¶ 139-141. 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. Id. Finally,
`empty conductor lumens could 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 techniques for filling
`
`13
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`

`

`IPR2018-00147
`Patent 8,650,747 B2
`
`
`the unoccupied portions of the conductor lumens. And to do so,
`a POSA would have thus considered other medical device
`references to identify suitable methods for filling lumens and
`other spaces within elongate structures having conductive wires
`therein.
`Pet. 39–40. 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 be liquid epoxy, “‘[i]n order to
`substantially increase the kink resistance of the flexible elongate tubular
`member 26.’” Pet. 40 (citing Ex. 1006, 7:3–5).
`
`An annotated version of Figure 3 of Ormsby is reproduced below.
`
`
`
`Ormsby FIG. 3 depicts “an enlarged cross-sectional view of the 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. Id. at 3–4. Conductive wires 56, 57, and fill
`material 81, are located in lumen 29. Id. at 5, 7.
`
`But, as the Patent Owner points out (Prelim. Resp. 29), Figure 3
`shows conductive wires 56 and 57 disposed in lumen 29. Material 81 fills
`lumen 29 in a portion occupied by conductive wires 56 and 57. Therefore,
`Figure 3 of Ormsby does not show the “solid, non-conductive material . . .
`filling [an] unoccupied portion of at least one [ ] conductor lumen[ ]”
`
`14
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`

`IPR2018-00147
`Patent 8,650,747 B2
`
`(claim 1), the unoccupied portion being that “in which none of the conductor
`wires is disposed, the unoccupied portion extending from an end of the
`conductor lumen” (claim 1), for which Petitioner relies upon Ormsby.
`
`Petitioner has not shown that Ormsby discloses a material filling an
`unoccupied portion of a conductor lumen as claimed.
`
`Relying on Figure 3 of Black, Petitioner argues that Black
`discloses the technique of heating, then reflowing non-
`conductive lead elements, like its spacers, to fill its lumen space.
`See id. [Ex. 1008 5:28–45, 6:5–10, 7:12–23]; see also Ex. 1003,
`¶¶ 151–156. Specifically, Black discloses that “electrode spacers
`28 and terminal spacers 30 are placed in a state of flow, which,
`at least in part, results in a filling of regions between terminals
`16/electrodes 18 and stylet guide 24”—i.e., unoccupied portions
`or spaces in the conductor lumen. Ex. 1008, 7:13–16 (emphasis
`added).
`Pet. 42.
`
`Figure 3 of Black is reproduced below.
`
`
`Black FIG. 3 depicts a sectional view of an implantable lead.
`Ex. 1008, 3:6–7.
`
`
`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 (toriodal- or donut-
`15
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`

`

`IPR2018-00147
`Patent 8,650,747 B2
`
`
`shaped) space between the stylet tubing 24 and the outer tubing
`22, 23 in which the conductors 20 are disposed. There are spaces
`between the conductors at this stage of manufacture.
`Pet. 42.
`
`Black’s conductors 20 are wire strands. Ex. 1008, 4:3–35. They are
`situated in body 22 and outer tubing 23. “[B]ody 22 provides an enclosure
`for each conductor 20 that connects a terminal 16 with one or more
`electrodes 18.” Ex. 1008, 3:57–59. “Outer tubing 23 separates electrodes
`18 from terminals 16.” Ex. 1008, 6:37–38.
`
`Black describes a manufacture whereby a “completed assembly
`(FIG. 5 [reproduced below]) is then over-molded.” Ex. 1008, 7:5. Black
`discloses
`electrode spacers 28 and terminal spacers 30 are placed in a state
`of flow, which, at least in part, results in a filling of regions
`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.
` Ex. 1008, 7:13–18.
`
`
`
`But, as the Patent Owner argues (Prelim. Resp. 27), Black does not
`
`disclose “filling the unoccupied portion of at least one of the conductor
`lumens.” Rather, Black shows filling regions between terminals
`16/electrodes 18 and stylet tubing 24 (to which “conductors 20 are secured”
`(Ex. 1008, 6:5)) with insulative spacer material and fusing the material.
`
`
`
`16
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`IPR2018-00147
`Patent 8,650,747 B2
`
`Given that conductor 20 is disposed within tubing 23, Black insufficiently
`shows a “solid, non-conductive material … filling [an] unoccupied portion
`of at least one [ ] conductor lumen[ ]” (claim 1), the unoccupied portion
`being that “in which none of the conductor wires is disposed, the unoccupied
`portion extending from an end of the conductor lumen” (claim 1).
`
`
`Petitioner has not shown that Black discloses a material filling an
`unoccupied portion of a conductor lumen as claimed.
`
`In citing Ormsby and Black, Petitioner has identified “suitable
`methods for filling lumens and other spaces within elongate structures
`having conductive wires therein.” Pet. 40. But Petitioner has not presented
`sufficient evidence that it would have been obvious to fill an unoccupied
`portion of a conductor lumen, as claimed.
`
`Petitioner argues that “a POSA would have recognized that leaving
`long, empty portions of a conductor lumen could be an undesirable
`condition, depending on the application.” Pet. 39. Petitioner relies on
`Declarant’s testimony, which states, in relevant part, that
`[a]s Ormsby (Ex. 1006) confirms, a POSA would recognize that
`having long portions of a conductor lumen remain empty (as
`opposed to a specifically designed, empty, non-conductor lumen)
`can be an undesirable condition, depending on the application.
`For example, a long and empty conductor lumen would be more
`susceptible to perforation, kinking, or other material damage,
`such as during insertion into the human body. Further, having
`empty conductor lumens of varying lengths could cause
`variations in the flexibility of the implantable lead. Finally,
`empty conductor lumens increase the chance of separation of
`components of the lead body from one another.
`Ex. 1003 ¶ 140.
`
`However, Ormsby’s lumens are not empty. They have conductor
`wires disposed within them. Ormsby discloses that
`
`17
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`IPR2018-00147
`Patent 8,650,747 B2
`
`
`[i]n order to substantially increase the kink resistance of
`the flexible elongate tubular member 26, the lumen 29 therein
`can be filled with a filler 81 of a suitable material such as liquid
`epoxy or resin and permitted to harden. . . . [I]t can be seen that
`the filler 81 fills the void within the lumen and greatly reduces
`the possibility of kinking of the hypotube forming the flexible
`elongate tubular member 26.
`Ex. 1006, 7:3–10. But these disclosures are in the context of filling a void in
`the lumen. Despite the presence of a void, the lumen is nevertheless still
`occupied with conductor wires 56, 57. See Ex. 1006, Fig. 3. This is in
`contrast to what is claimed, which calls for filling an “unoccupied” portion
`of a lumen; that is, a portion “in which none of the conductor wires is
`disposed” (claim 1). Ormsby alone is insufficient as a basis for finding that
`a person of ordinary skill in the art “would recognize that having long
`portions of a conductor lumen remain empty . . . can be an undesirable
`condition.” Pet. 39 (quoting Ex. 1003 ¶ 140).
`
`And, Petitioner’s Declarant’s statements that
`[(a)] a long and empty conductor lumen would be more
`susceptible to perforation, kinking, or other material damage,
`such as during insertion into the human body[; (b)] having empty
`conductor lumens of varying lengths could cause variations in
`the flexibility of the implantable lead[; and, (c)] empty conductor
`lumens increase the chance of separation of components of the
`lead body from one another
`are not supported with underlying facts or data. Ex. 1003 ¶ 140; 37 C.F.R.
`§ 42.65(a). Furthermore, there is insufficient evidence in this record
`showing Stolz’s “unoccupied” lumens exhibit any of the problems Declarant
`has attributed to long and empty lumens.
`
`Stolz discloses disposing a non-conductive material “radially
`underneath” the conductive contacts. But Stolz does not disclose a solid,
`
`18
`
`

`

`IPR2018-00147
`Patent 8,650,747 B2
`
`non-conductive material filling an unoccupied portion of a conductor lumen
`as claimed. Ormsby and Black disclose filling an occupied lumen.
`Petitioner provides no explanation as to how one of ordinary skill in the art,
`given Stolz, Ormsby, and Black, would have been led to both dispose a non-
`conductive material “radially underneath” conductive contacts and fill an
`unoccupied lumen, as claimed.
`
`We are unpersuaded that the fact of disposing a non-conductive
`material “radially underneath” the conductive contacts (i.e., Stolz) and
`filling an occupied lumen (i.e., Ormsby and Black) were known at the time
`of the invention is, in and of itself, a sufficient reason to render obvious the
`claimed method comprising providing a solid, non-conductive material
`disposed radially underneath conductive contacts and filling an unoccupied
`portion of a conductor lumen.
`
`For the above reasons, we are unpersuaded that the Petition
`establishes a reasonable likelihood that claim 1 is unpatentable over Stolz,
`Ormsby, and Black.
`
`Claims 2–10
`
`Claims 2–10 each depend from claim 1 and, therefore, also include
`the aforementioned limitations of providing of a solid, non-conductive
`material disposed radially underneath conductive contacts, and filling an
`unoccupied portion of a conductor lumen, as set forth in claim 1.
`Petitioner’s position that the combination of Stolz, Ormsby, and Black
`discloses said limitation, or that it would have been obvious, also applies to
`claims 2–10. Pet. 47–56.
`
`19
`
`

`

`IPR2018-00147
`Patent 8,650,747 B2
`
`For the same reasons as set forth above, we are unpersuaded that
`
`Petitioner has shown sufficiently that, one of ordinary skill in the art would
`have found it obvious to provide a solid, non-conductive material disposed
`radially underneath conductive contacts and to fill an unoccupied portion of
`a conductor lumen as claimed. As such, we are unpersuaded that the
`Petition establishes a reasonable likelihood that claims 2–10 are
`unpatentable over Stolz, Ormsby, and Black.
`
`Claim 11
`
`Claim 11 parallels claim 1, but more narrowly requires “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.”
`
`Petitioner relies on the same arguments and evidence as relied on for
`claim 1. Pet. 57–58. Accordingly, our analysis is the same, as set forth
`above for claim 1.
`
`For the above reasons, we are unpersuaded that the Petition
`establishes that it is more likely than not that claim 11 is unpatentable over
`Stolz, Ormsby, and Black.
`
`Claims 12–19
`Claims 12–19 depend ultimately from claim 11 and, therefore, also
`include the aforementioned providing “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.”
`Petitioner’s position that the combination of Stolz, Ormsby, and Black
`
`20
`
`

`

`IPR2018-00147
`Patent 8,650,747 B2
`
`discloses said limitation, or that it would have been obvious, also applies to
`claims 12–19. Pet. 58–61.
`
`For the same reasons as set forth above we are unpersuaded that
`Petitioner has shown sufficiently that, given disposing a non-conductive
`material “radially underneath” the conductive contacts (i.e., Stolz) and
`filling an occupied lumen (i.e., Ormsby and Black), one of ordinary skill in
`the art would have been led to provide a solid, non-conductive material
`disposed radially underneath conductive contacts within portions of a
`conductor lumens not occupied by conductor wire as claimed.
`
`As such, we are unpersuaded that the Petition establishes that it is
`more likely than not that claims 12–19 are unpatentable over Stolz, Ormsby,
`and Black.
`
`III. CONCLUSION
`For the foregoing reasons, we determine that Petitioner has not
`
`demonstrated a reasonable likelihood that it would prevail with respect to the
`claims challenged in the Petition. We do not institute an inter partes review
`of claims 1–19 of the ’747 patent.
`
`
`IV. ORDER
`
`It is
`
`ORDERED that the Petition is denied, and that we do not institute an
`
`inter partes review of claims 1–19 of the ’747 patent.
`
`
`
`
`
`
`
`21
`
`

`

`IPR2018-00147
`Patent 8,650,747 B2
`
`PETITIONER:
`
`Jon E. Wright
`jwright-PTAB@skgf.com
`Ian Soule
`isoule-PTAB@skgf.com
`Richard D. Coller III
`rcoller-ptab@skgf.com
`Nirav Desai
`Ndesai-PTAB@skgf.com
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`Ching-Lee Fukuda
`clfukuda@sidley.com
`Benjamin H. Huh
`bhuh@sidley.com
`SIDLEY AUSTIN LLP
`
`PATENT OWNER:
`
`David Caine
`david.caine@apks.com
`Wallace Wu
`wallace.wu@apks.com
`ARNOLD & PORTER KAYE SCHOLER LLP
`
`22
`
`

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