By: David A. Caine (Reg. No. 52,683)
`Arnold & Porter Kaye Scholer LLP
`3000 El Camino Real
`Five Palo Alto Square, Suite 500
`Palo Alto, California 94306-3807
`Telephone: 650.319.4500
`Facsimile: 650.319.4700
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`NEVRO CORP.
`Petitioner,
`
`v .
`
`BOSTON SCIENTIFIC NEUROMODULATION CORP.
`Patent Owner
`
`Inter Partes Review No. 2018-00148
`U.S. Patent No. 8,646,172
`
`PATENT OWNER’S PRELIMINARY RESPONSE
`
`

`

`IPR No. 2018-00148
`Patent No. 8,646,172
`
`TABLE OF CONTENTS
`
`I.
`
`STATEMENT OF PRECISE RELIEF REQUESTED ....................................... 1
`
`II.
`
`INTRODUCTION ............................................................................................... 1
`
`III. THE ’172 PATENT .......................................................................................... 4
`
`IV. THE ASSERTED REFERENCES .................................................................11
`
`A.
`
`B.
`
`Stolz .............................................................................................................11
`
`Black ............................................................................................................14
`
`C. Ormsby ........................................................................................................17
`
`V. STATEMENT OF THE LAW ..........................................................................19
`
`VI. CLAIM CONSTRUCTION ...........................................................................22
`
`VII. GROUND 1: THE COMBINATION OF STOLZ, ORMSBY, AND BLACK
`DOES NOT RENDER OBVIOUS CLAIMS 1-11 .................................................23
`
`A. Claims 1 and 6: Neither Stolz, Ormsby, nor Black Disclose, Teach, or
`Suggest “Placing Non-Conductive Material Into a Portion of at Least one of the
`Conductor Lumens of the Lead Body, Wherein at Least a Portion of the Non-
`Conductive Material is Disposed Radially Beneath the Conductive Contacts” ..23
`
`1.
`
`2.
`
`3.
`
`Stolz ..........................................................................................................24
`
`Black .........................................................................................................26
`
`Ormsby .....................................................................................................28
`
`Claim 6: Neither Stolz, Black, Ormsby, nor Modern Plastics Encyclopedia
`B.
`Disclose, Teach or Suggest the Step of “Heating the Nonconductive Material at a
`Temperature in a Range of 140 to 250 Degrees Celsius for a Period in a Range of
`
`i
`
`

`

`IPR No. 2018-00148
`Patent No. 8,646,172
`15 to 120 Seconds to Cause the Non-Conductive Material to Thermally Reflow
`or Melt” .................................................................................................................29
`
`Stolz, Black and Ormsby do not disclose, teach or suggest the heating
`1.
`step. 30
`
`The Modern Plastics Encylopedia and Cartmell do not disclose, teach or
`2.
`suggest the specific recited parameters for the heating step. ............................30
`
`Claims 2-5 and 7-11: The Cited References do not Render Dependent
`C.
`Claims 2-5 or 7-11 Obvious .................................................................................32
`
`Petitioner has not Identified a Sufficient Reason to Combine its Cited
`D.
`References.............................................................................................................33
`
`Stolz Discloses That its Multi-Lumen Lead Body Addresses the Alleged
`1.
`Advantages Conferred by Ormsby’s Back-Fill.................................................33
`
`The Alleged Reasons to Modify Stolz Using Black are Already
`2.
`Addressed by Stolz ............................................................................................40
`
`VIII. RESERVATION OF RIGHTS ....................................................................40
`
`ii
`
`

`

`IPR No. 2018-00148
`Patent No. 8,646,172
`
`TABLE OF AUTHORITIES
`
`CASES
`Agrinomix, LLC v. Mitchell Ellis Products, Inc.,
`
`IPR2017-00525, Paper 8, (PTAB Jun. 14, 2017) ............................ 17, 19, 20, 29
`
`Page(s)
`
`Belden Inc. v. Berk-Tek LLC,
`805 F.3d 1064 (Fed. Cir. 2015) .......................................................................... 21
`
`Broadcom Corp. v. Emulex Corp.,
`732 F.3d 1325 (Fed. Cir. 2013) .................................................................... 22, 23
`
`CFMT, Inc. v. YieldUp Int’l Corp.,
`349 F.3d 1333 (Fed. Cir. 2003) .......................................................................... 20
`
`DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc.,
`567 F.3d 1314 (Fed. Cir. 2009) .......................................................................... 20
`
`Graham v. John Deere Co.,
`383 U.S. 1 (1966) ................................................................................................ 20
`
`In re Kahn,
`441 F.3d 977 (Fed. Cir. 2006) ............................................................................ 20
`
`In re Rijckaert,
`9 F.3d 1531 (Fed. Cir. 1993) .............................................................................. 20
`
`InTouch Techs., Inc. v. VGO Commc’ns, Inc.,
`751 F.3d 1327 (Fed. Cir. 2014) .......................................................................... 21
`
`Kinetic Concepts, Inc. v. Smith & Nephew, Inc.,
`688 F.3d 1342 (Fed. Cir. 2012) .................................................................... 21, 22
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ...................................................................................... 20, 21
`
`Oil States Energy Services, LLC v. Greene’s Energy Grp.,
`639 F. App’x 639 (Fed. Cir. 2016), cert. granted, 137 S. Ct. 2239
`(2017) ............................................................................................................ 40, 41
`
`iii
`
`

`

`IPR No. 2018-00148
`Patent No. 8,646,172
`
`Pers. Web Techs., LLC v. Apple, Inc.,
`848 F.3d 987 (Fed. Cir. 2017) ............................................................................ 21
`
`St. Jude Med., Inc. v. Access Closure, Inc.,
`729 F.3d 1369 (Fed. Cir. 2013) .......................................................................... 20
`
`Trivascular, Inc. v. Samuels,
`812 F. 3d 1056 (Fed. Cir. 2012) ......................................................................... 36
`
`STATUTES
`
`35 U.S.C. § 325(d) ................................................................................................... 19
`
`iv
`
`

`

`IPR No. 2018-00148
`Patent No. 8,646,172
`STATEMENT OF PRECISE RELIEF REQUESTED
`
`I.
`
`On November 3, 2017, Nevro Corp. (“Petitioner”) submitted a Petition for
`
`Inter Partes Review (“Petition”) challenging claims 1-11 (“Challenged Claims”) of
`
`U.S. Patent No. 8,646,172 (“the ’172 Patent”) (Ex. 1001). Boston Scientific
`
`Neuromodulation Corp. (“Patent Owner”) hereby responds to the Petition and
`
`explains below that Petitioner has not demonstrated that a reasonable likelihood
`
`exists that it would prevail as to any Challenged Claim.
`
`II.
`
`INTRODUCTION
`
`The Petition challenges the patentability of the Challenged Claims with one
`
`primary reference, Stolz. The claims recite assemblies for manufacturing leads for
`
`use in spinal cord stimulation (SCS) systems, which are used to treat chronic pain
`
`by providing electrical stimulation pulses to an electrode array at the lead end,
`
`placed epidurally near a patient’s spine. The leads are detachably connected to an
`
`implantable pulse generator (IPG). Because the leads are implantable medical
`
`devices, their components and dimensions must be carefully selected for
`
`biocompatibility and precision. It is also important, however, to produce SCS
`
`leads reliably and cost-effectively. To address this, the ’172 Patent combines
`
`several features into unique assemblies that are especially useful for the
`
`manufacture of SCS leads. These features include a multi-lumen body with
`
`conductor lumens arranged around a central stylet lumen, the use of multiple
`
`1
`
`

`

`IPR No. 2018-00148
`Patent No. 8,646,172
`contacts that fit radially over the conductor lumens at the end of the lead assembly,
`
`a solid, non-conductive material disposed within those conductor lumens and
`
`radially underneath the conductive contacts, and, in some claims, thermal reflow of
`
`the non-conductive material within the conductor lumens. Stolz, Black, and
`
`Ormsby do not disclose, teach or suggest methods for manufacturing SCS leads
`
`employing these features.
`
`First, Stolz, Black, and Ormsby fail to disclose “placing non-conductive
`
`material into a portion of at least one of the conductor lumens of the lead body,
`
`wherein at least a portion of the non-conductive material is disposed radially
`
`beneath the conductive contacts,” as required by claims 1-11. None of these
`
`references disclose the use of a non-conductive material in a conductor lumen prior
`
`to a thermal reflow step.
`
`Second, none of the cited references discloses, teaches or suggests the
`
`limitation “heating the non-conductive material to cause the non-conductive
`
`material to thermally reflow or melt” as required by claim 2; the limitation
`
`“heating the non-conductive material and spacers to cause the non-conductive
`
`material to thermally reflow or melt and to cause the non-conductive material and
`
`spacers to thermally fuse together” as required by claim 5; or the limitation
`
`“heating the nonconductive material at a temperature in a range of 140 to 250
`
`degrees Celsius for a period in a range of 15 to 120 seconds to cause the non-
`
`2
`
`

`

`IPR No. 2018-00148
`Patent No. 8,646,172
`conductive material to thermally reflow or melt,” as required by claims 6-11.
`
`Because none of the references discloses, teaches or suggests the placement of
`
`non-conductive material in unoccupied portions of the conductor lumens, none of
`
`them discloses, teaches or suggests thermally fusing that non-conductive material
`
`to the lead body.
`
`Third, Petitioner has not demonstrated a legally sufficient motivation to
`
`combine the asserted references in Grounds 1 or 2. Petitioner argues that
`
`Ormsby’s disclosure of the use of fill material to increase the kink resistance of the
`
`body of an ultrasonic guidewire provides a motivation to fill void spaces in a
`
`different portion of an SCS lead. A POSA, however, would not have been
`
`motivated to modify Stolz or to apply a thermal reflow step from Black or move
`
`non-conductive material from the body of Ormsby’s guidewire—a medical device
`
`that is substantially different from an SCS lead in function and use—to lumens
`
`undergirding Stolz’s conductive contact arrays, as suggested in both Grounds 1 and
`
`2. As discussed below, a POSA would have understood Stolz’s body design to
`
`have already addressed the problems that Petitioner identifies in the art.
`
`Petitioner’s proposed combination would create redundancies that would serve no
`
`purpose other than hindsight reconstruction of the invention and would increase the
`
`complexity and cost of the device.
`
`3
`
`

`

`IPR No. 2018-00148
`Patent No. 8,646,172
`The Petition thus fails to establish by a preponderance of the evidence that
`
`Petitioner is reasonably likely to demonstrate that any of the Challenged Claims
`
`are unpatentable. Institution should be denied as to both grounds of the Petition.
`
`III. THE ’172 PATENT
`
`The ’172 Patent is titled “Electrode Array Assembly and Method of Making
`
`Same.” The ’172 Patent discloses and claims methods of manufacture for
`
`stimulation leads for use in an SCS system. Once manufactured, the leads are used
`
`to treat chronic pain by conducting electrical stimulation current pulses from an
`
`implantable pulse generator when placed epidurally in close proximity to a
`
`patient’s spine. (Ex. 1001 at 3:46-57; 4:13-16.) Figure 2 of the ’172 Patent shows
`
`this arraignment:
`
`4
`
`

`

`IPR No. 2018-00148
`Patent No. 8,646,172
`
`Prior art methods of constructing leads had both reliability and cost
`
`limitations because manufacturing multi-contact, percutaneous stimulation leads is
`
`an involved process. As the ’172 Patent explains, it is desirable to manufacture
`
`leads “efficiently, with the fewest number of process steps, [to] maximize the
`
`manufacturing yield, and hence reduce the cost of goods of building the leads,” and
`
`there is “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 at 1:66-2:6.)
`
`5
`
`

`

`IPR No. 2018-00148
`Patent No. 8,646,172
`The ’172 Patent addresses this need by disclosing unique methods for
`
`manufacturing SCS leads in efficiently and reliably. These methods include
`
`several key features that are found in independent claim 1, the broadest claim in
`
`the Patent:
`
`1. A method of manufacturing a stimulation lead comprising:
`[a1] providing a lead body comprising an insulation section, the
`insulation section defining a central lumen extending along the
`insulation section and a plurality of conductor lumens extending along
`the insulation section and arranged around, and external to, the central
`lumen, the lead body further comprising a plurality of conductive
`contacts located along an axial end of the lead body, and a plurality of
`conductor wires, wherein each of the conductor wires is disposed
`within one of the plurality of conductor lumens and each of the
`conductor lumens of the plurality of conductor lumens has at least one
`of the conductor wires of the plurality of conductor wires disposed
`therein, wherein a portion of the conductor lumens is disposed radially
`beneath the conductive contacts;
`[b1] after providing the lead body, conductively coupling at least
`one of the plurality of conductor wires to each of the conductive
`contacts; and
`[c1] after providing the lead body, placing non-conductive material
`into a portion of at least one of the conductor lumens of the lead body,
`wherein at least a portion of the non-conductive material is disposed
`radially beneath the conductive contacts.
`
`6
`
`

`

`IPR No. 2018-00148
`Patent No. 8,646,172
`These claim features are illustrated, for an exemplary lead and lead
`
`assembly, in figures 5A, 5B, and 6A of the ’172 Patent. Figures 5A and 5B show,
`
`in an exemplary lead, several of the limitations found in element [a1]:
`
`The figures show eight conductor lumens extending along the insulation section of
`
`a lead body, identified as element 116. The conductor lumens 116 are disposed
`
`circumferentially around the central stylet lumen 114. (Ex. 1001 at 5:46-53.) The
`
`figures also show the disposition of the conductor wires (122) within the conductor
`
`lumens, as required by limitation [a1]. (Id.)
`
`The remaining elements of claim 1 are shown, in exemplary fashion, in
`
`figure 6A, which shows a cross section of an end of a stimulation lead assembly:
`
`7
`
`

`

`IPR No. 2018-00148
`Patent No. 8,646,172
`
`Conductive contacts (17)
`Conductor wires (122)
`
`Weld
`Non-conductive material (60)
`
`The conductive contacts (element 17 shown in green) are arranged along the
`
`end of the lead assembly with portions of the conductor lumens (filled by the
`
`conductor wires (122) and the non-conductive material (60)) disposed radially
`
`underneath them per element [a1]. The conductor wires are connected to the
`
`contacts on a one-to-one basis via welds shown in red, per element [b1]. Finally, a
`
`solid, non-conductive material (60), highlighted in blue, is shown disposed radially
`
`underneath the conductive contacts (17) as required by claim element [c1].
`
`Independent claim 6 is narrower than claim 1:
`6. A method of manufacturing a stimulation lead comprising:
`[a6] providing a lead body comprising an insulation section, the
`insulation section defining a central lumen extending along the
`insulation section and a plurality of conductor lumens extending along
`
`8
`
`

`

`IPR No. 2018-00148
`Patent No. 8,646,172
`the 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 one of the plurality of conductor lumens and each of the
`conductor lumens of the plurality of conductor lumens has at least one
`of the conductor wires of the plurality of conductor wires disposed
`therein, wherein a portion of the conductor lumens is disposed radially
`beneath the conductive contacts;
`[b6] after providing the lead body, conductively coupling at least
`one of the plurality of conductor wires to each of the conductive
`contacts;
`[c6] after providing the lead body, placing non-conductive material
`into a portion of at least one of the conductor lumens of the lead body,
`wherein at least a portion of the non-conductive material is disposed
`radially beneath the conductive contacts; and
`the
`[d6] after placing
`the non-conductive material, heating
`nonconductive material at a temperature in a range of 140 to 250
`degrees Celsius for a period in a range of 15 to 120 seconds to cause
`the non-conductive material to thermally reflow or melt.
`Claim 6 adds an additional limitation to claim 1: it requires a thermal step
`
`[d6] wherein the non-conductive material is caused to thermally reflow or melt
`
`through the application of an appropriate amount of heat. An exemplary thermal
`
`fusion step is illustrated in figure 6B of the ’172 Patent:
`
`9
`
`

`

`IPR No. 2018-00148
`Patent No. 8,646,172
`
`(Ex. 1001 at 6:11-25.) During the appropriate application of heat, the non-
`
`conductive material, in this embodiment a monofilament (60), thermally reflows or
`
`melts; as a result of this process, the non-conductive material is thermally fused to
`
`material from the lead body as well as (in some dependent claims) material from
`
`non-conductive spacers placed between conductive contacts (61). (Id.)
`
`The unique combinations of steps, as recited in independent claims 1 and 6,
`
`constitute methods of reliably manufacturing leads quickly and efficiently.
`
`Further, as detailed below, these elements were not present in the prior art.
`
`10
`
`

`

`IPR No. 2018-00148
`Patent No. 8,646,172
`
`IV. THE ASSERTED REFERENCES
`
`A.
`
`Stolz
`
`Stolz was before the patent Examiner during the prosecution of the ’172
`
`Patent. Although the specific patent publication cited by Petitioner, U.S.
`
`Publication No. 2003/0199950, was not before the Examiner, it is the publication
`
`of U.S. Application 10/128,883, which subsequently issued as U.S. Patent
`
`7,184,840 (“Stolz ’840”). Furthermore, U.S. Patent Application 10/411,775, which
`
`claims priority to 10/128,883, was published as U.S. Patent Publication
`
`2004/0024440 (“Cole ’440”). Both Stolz ’840 and Cole ’440 are listed on the face
`
`of the ’172 Patent and marked with an asterisk, indicating that they were cited by
`
`the Examiner during prosecution. (Ex. 1001 at p. 1.)
`
`Stolz discloses stimulation leads—and methods of making isolation spaces
`
`in stimulation leads—wherein the electrical contacts are not welded directly to the
`
`conductor wires to prevent the weld from containing material from the conductor
`
`wires. (Ex. 1005 ¶¶ 6, 46.) Stolz considered this undesirable for a variety of
`
`reasons: conductor material can weaken the weld, increase chance of separation,
`
`cause silver exposure to tissue if silver conductors are used, and potentially cause
`
`corrosion once implanted. (Id. ¶ 4.) Stolz accomplishes this by connecting the
`
`conductor wires to a crimp sleeve contained in a coupling element, as shown in
`
`figure 13 of Stolz:
`
`11
`
`

`

`IPR No. 2018-00148
`Patent No. 8,646,172
`
`Stolz discloses that the coupling element, identified as 112, has both a conductor
`
`coupling, element 500, and a contact coupling, element 502. (Id. ¶¶ 47, 49.) The
`
`sleeve is then inserted into a “contact slot,” element 508, in one of the cylindrical
`
`conductor contacts as shown in figures 14 and 15:
`
`(Id. ¶ 46.) The sleeve is then welded to the conductive contact. (Id.) The
`
`connection sleeve contains an isolation space that, in some embodiments, contains
`
`12
`
`

`

`IPR No. 2018-00148
`Patent No. 8,646,172
`epoxy. (Id. ¶ 46.) Stolz teaches that this isolation space is necessary because
`
`“silver is not wanted in the weld . . . pool because silver potentially weakens the
`
`strength and integrity of a weld” and “it is desirable to avoid having silver contact
`
`the outside surface of the lead to avoid any direct contact with tissue.” (Id.)
`
`Stolz also discloses a thermal tipping procedure. However, as shown in
`
`figures 6 through 9 of Stolz, the Stolz tipping procedure does not result in material
`
`being disposed under Stolz’s conductive contacts:
`
`(Id. at figs. 6-9; see also Petition 36-37.) Rather the material stops short of the
`
`conductors and merely seals the lumens. (Ex. 1005 ¶¶ 33, 35, Figs. 7, 9 (showing
`
`that the proximal flair and the distal tips seal the lumens prior to the first
`
`electrically conductive contact; Fig. 7 in particular shows the lumens unoccupied
`
`by non-conductive material once they reach the proximal-most conductive
`
`contact).)
`
`13
`
`

`

`IPR No. 2018-00148
`Patent No. 8,646,172
`Stolz does not disclose any of the following: a solid, non-conductive
`
`material disposed, at least in part, radially underneath the conductive contacts;
`
`thermal reflow of the non-conductive material; or selecting exactly eight conductor
`
`lumens.
`
`B.
`
`Black
`
`Black identifies that a problem with prior art stimulation leads is that their
`
`manufacturing processes can result in variations in the thickness of the stimulation
`
`lead. (Ex. 1008 at 1:22-32, 2:50-55.) To address this, Black discloses isodiametric
`
`stimulation leads—as well as assemblies for and methods of making such
`
`stimulation leads—having an array of electrodes and spacers at the end of the lead
`
`body. (Id. Figs. 1, 2.) Black’s leads utilize a single conductor lumen surrounding
`
`a central stylet lumen.
`
`(Id. Fig. 3, 4:36-40.) As shown in Figure 3, the single lumen contains all of the
`
`lead’s conductors: the stylet (100) is shown in the central stylet lumen surrounded
`
`14
`
`

`

`IPR No. 2018-00148
`Patent No. 8,646,172
`by stylet tubing (24). The individual conductors (20) are arranged in a single,
`
`empty lumen, which is then surrounded by the outer tubing (23) which forms the
`
`lead body (22). An over-molding process is used to form an isodiametric lead
`
`body, which, in the process, creates a thermally fused matrix of supporting material
`
`out of the spacers. (Id. 7:5-11.) This matrix supports the electrode elements at the
`
`proximal and distal ends of the lead body. (Id. 7:12-24.) Black also discloses that
`
`the prior art taught that “to strengthen the plurality of element interfaces found in
`
`the stimulation/sensing portions and
`
`terminal portions of
`
`these
`
`leads, a
`
`composition, for example, medical grade epoxy, is injected within an interior of the
`
`leads in and about the stimulation/sensing portions and the terminal portions.” (Id.
`
`1:45-50.)
`
`Black was discussed extensively during the prosecution of the ’172 Patent,
`
`and is cited on its face. (Ex. 1001 at References Cited.) During prosecution, the
`
`applicants distinguished Black on the grounds that it does not disclose “placing
`
`non-conductive material into a portion of at least one of the conductor lumens of
`
`the lead body, wherein at least a portion of the non-conductive material is disposed
`
`radially beneath the conductive contacts.” (See Ex. 1002 at 69-70, 85-87.) After
`
`further examination, the Examiner then allowed the claims over Black. (See Ex.
`
`1002 at 40.)
`
`15
`
`

`

`IPR No. 2018-00148
`Patent No. 8,646,172
`Nevertheless, Petitioner argues that the “[e]xaminer’s fail[ed] to appreciate”
`
`that Black discloses a thermal reflow step in which Black’s single conductor lumen
`
`is partially filled with spacer material. (Petition 17; see also Ex. 1008 at 7:12-24.)
`
`Petitioner then argues that Black’s thermal reflow step would have resulted in the
`
`disposition of a non-conductive material radially underneath Black’s contacts.
`
`Petitioner’s argument, however, ignores that both claims 2 and 6 of the ’172 Patent
`
`contain a thermal reflow limitation that is independent from the non-conductive
`
`material limitation. The insertion of the non-conductive material is a predicate for
`
`the subsequent limitation, in claims 2 and 6, requiring that “the non-conductive
`
`material” be heated “to cause the non-conductive material to thermally reflow or
`
`melt,” as required by claim 2, or “heating the nonconductive material at a
`
`temperature in a range of 140 to 250 degrees Celsius for a period in a range of 15
`
`to 120 seconds to cause the non-conductive material to thermally reflow or melt,”
`
`as required by claim 6. (Emphasis added.) Black’s disclosure of spacer material
`
`that is reflowed as a consequence of heat transfer during over-molding thus cannot
`
`constitute “placing non-conductive material into a portion of at least one of the
`
`conductor lumens of the lead body, wherein at least a portion of the non-
`
`conductive material is disposed radially beneath the conductive contacts” within
`
`the meaning of claims 1 and 6 of the ’172 Patent. Furthermore, the thermal flow
`
`limitation was not relied on by the Examiner to distinguish Black, Stolz, and the
`
`16
`
`

`

`IPR No. 2018-00148
`Patent No. 8,646,172
`other prior art of record. Thus, Petitioner does no more than re-present Black in
`
`“the same substantive manner,” and the Board may “decline to institute inter
`
`partes review on those grounds . . . .” See Agrinomix, LLC v. Mitchell Ellis Prods.,
`
`Inc., IPR2017-00525, Paper 8, at 11-12 (P.T.A.B. Jun. 14, 2017)
`
`C.
`
`Ormsby
`
`Ormsby addresses the design of a guidewire with sideways-looking
`
`capabilities for use with over-the-wire catheters. The guidewire provides rigidity
`
`for the over-the-wire catheter so that it can be used for “treatment of stenoses in
`
`small vessels with over-the-wire catheters.” (Ex. 1006 at 1:16-17.) This function
`
`means that the guidewire has several specific requirements: a small cross section
`
`and a flexible tip with properties similar to existing guidewires and the ability to
`
`“provide … good torque transmission while retaining both flexibility and kink
`
`resistance.” (Id. 1:13-30; see also id. 8:7-18.) This allows the guidewire to be
`
`advanced through an artery while the physician uses ultrasonic imaging to position
`
`the guidewire appropriately to repair the stenosis. A balloon catheter or stent is
`
`then advanced into the body using the guidewire as a rigid guide. (Id. 9:3-21.)
`
`To address this, Ormsby discloses a guidewire device for ultrasonic imaging
`
`using a rotating ultrasonic transducer, and the disclosures are specifically targeted
`
`at designing a guidewire capable of providing good torque transmission and a
`
`flexible tip with properties similar to prior art ultrasonic systems. Ormsby
`
`17
`
`

`

`IPR No. 2018-00148
`Patent No. 8,646,172
`discloses that the guidewire itself must be made of “a material having high torsion
`
`capabilities,” such as a stainless steel material called a hypotube, so that rotation
`
`applied by the physician at the proximal end is transmitted to the distal end, and
`
`the distal end rotates at a substantially one-to-one ratio with the proximal end. (Id.
`
`7:4-11.) The guidewire has two conductors disposed within a central lumen that is
`
`then filled with a filling material—such as liquid epoxy, resin, or a powdered
`
`polymer that is subsequently melt-formed—to substantially reduce the possibility
`
`of kinking. (See id. 7:4-10, 7:27-30.)
`
`Ormsby does not disclose methods for manufacturing stimulation leads; a
`
`plurality of conductor lumens disposed circumferentially around a central lumen
`
`and extending along the lead body; a plurality of conductor wires disposed in the
`
`conductor lumens; a solid, non-conductive material disposed, at least in part,
`
`radially beneath the conductive contacts; thermal reflow of the non-conductive
`
`material; or selecting exactly eight conductor lumens. In addition, the Petition fails
`
`to establish that one skilled in the art would have consulted Ormsby when
`
`determining how to make SCS leads. The Petition relies on Ormsby as prior art,
`
`but does not establish that one skilled in the art would have looked to ultrasonic
`
`imaging guidewires—which are designed for temporary use and are subject to
`
`different stresses during use due to the necessity of rotating them during
`
`operation—when designing SCS leads. (Petition 40-41.) Nor does the Petition
`
`18
`
`

`

`IPR No. 2018-00148
`Patent No. 8,646,172
`account for the differences between the purpose of SCS leads contacts and
`
`Ormsby’s guidewire. SCS leads, as discusses above in section III, deliver
`
`electrical stimulation to a patient’s spine. Ormsby’s guidewire, by contrast, uses
`
`an ultrasonic transducer to emit ultrasonic energy and then uses the reflected
`
`ultrasonic echoes to create an image of the surrounding tissue. (Ex. 1006 at 7:27-
`
`8:6.) Ormsby’s guidewire is therefore not intended for “stimulation,” as claims 1
`
`and 6 require. The Petition utterly fails to acknowledge this difference, much less
`
`provide any explanation for why a POSA would look to Ormsby in light of the
`
`different nature of their intended use.
`
`The Petition’s accompanying expert declaration fails to remedy theses
`
`deficiency, as it merely relies on the Petitioner’s counsel for the assertion that
`
`Ormsby qualifies as prior art and does not explain why one skilled in the art would
`
`have consulted imaging guidewires when designing SCS leads. (See Ex. 1003 ¶¶
`
`89-90.)
`
`V.
`
`STATEMENT OF THE LAW
`In determining whether to institute an Inter Partes Review, the PTO may
`
`“take into account whether, and reject the petition or request because, the same or
`
`substantially the same prior art or arguments previously were presented to the
`
`Office.” 35 U.S.C. § 325(d); Agrinomix, at 10. Where a reference “was previously
`
`presented to, and considered by, the Office in the same substantive manner as
`
`19
`
`

`

`IPR No. 2018-00148
`Patent No. 8,646,172
`Petitioner now advocates,” the Office has discretion to “decline to institute inter
`
`partes review on those grounds ….” Agrinomix at 11-12. This exercise of
`
`discretion is warranted because “the Board weighs petitioners’ desires to be heard
`
`against the interests of patent owners, who seek to avoid harassment.” Id. at 10.
`
`Obviousness is a question of law premised on underlying issues of fact, all
`
`of which must be considered, including: (i) the scope and content of the prior art;
`
`(ii) the level of ordinary skill in the art; (iii) the differences between the claimed
`
`invention and the prior art; and (iv) secondary considerations of nonobviousness,
`
`such as commercial success, long-felt need, and the failure of others. KSR Int’l
`
`Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007); Graham v. John Deere Co., 383
`
`U.S. 1, 17-18 (1966). For a claim to be found obvious, each element must be
`
`disclosed in prior art references. See St. Jude Med., Inc. v. Access Closure, Inc.,
`
`729 F.3d 1369, 1381 (Fed. Cir. 2013); CFMT, Inc. v. YieldUp Int’l Corp., 349
`
`F.3d 1333, 1342 (Fed. Cir. 2003); In re Rijckaert, 9 F.3d 1531, 1534 (Fed. Cir.
`
`1993).
`
`However, “a patent … is not proved obvious merely by demonstrating
`
`that each of its elements was, independently, known in the prior art.” KSR Int’l
`
`Co., 550 U.S. at 418. Hindsight reconstruction of the claimed invention must be
`
`carefully guarded against. Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688
`
`F.3d 1342, 1368 (Fed. Cir. 2012). Thus, it is “important to identify a reason that
`
`20
`
`

`

`IPR No. 2018-00148
`Patent No. 8,646,172
`would have prompted a person of ordinary skill in the relevant field to combine
`
`the elements in the way the claimed new invention does.” KSR Int’l Co., 550 U.S.
`
`at 418. The rationale must be more than “mere conclusory statements; instead,
`
`there must be some articulated reasoning with some rational underpinning to
`
`support the legal conclusion of obviousness.” In re Kahn, 441 F.3d 977, 988
`
`(Fed. Cir. 2006); see InTouch Techs., Inc. v. VGO Commc’ns, Inc., 751 F.3d 1327,
`
`1351 (Fed. Cir. 2014).
`
`It is insufficient to identify reasons why a skilled artisan could make the
`
`alleged combination; the Petitioner must explain why the claimed references would
`
`have been combined and functional. Belden Inc. v. Berk-Tek LLC, 805 F.3d