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. 2018-00147
`U.S. Patent No. 8,650,747
`
`PATENT OWNER’S PRELIMINARY RESPONSE
`
`
`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. 2018-00147
`U.S. Patent No. 8,650,747
`
`PATENT OWNER’S PRELIMINARY RESPONSE
`
`
`
`TABLE OF CONTENTS
`
`IPR No. 2018-00147
`Patent No. 8,650,747
`
`Page
`
`I.
`
`II.
`
`III.
`
`IV.
`
`STATEMENT OF PRECISE RELIEF REQUESTED .................................. 1
`
`INTRODUCTION .......................................................................................... 1
`
`THE ’747 PATENT ......................................................................................... 4
`
`THE ASSERTED REFERENCES ................................................................11
`
`A. Stolz ...............................................................................................................11
`
`B. Black ..............................................................................................................14
`
`C. Ormsby...........................................................................................................17
`
`V.
`
`STATEMENT OF THE LAW ......................................................................20
`
`VI. CLAIM CONSTRUCTION ..........................................................................23
`
`VII. GROUND 1: THE COMBINATION OF STOLZ, ORMSBY, AND
`
`BLACK DOES NOT RENDER OBVIOUS CLAIMS 1-19 ........................23
`
`A. Claim 1: Neither Stolz, Ormsby, nor Black Disclose, Teach, or Suggest “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 Lumen ...........................................................23
`
`1.
`
`2.
`
`3.
`
`Stolz .....................................................................................................24
`
`Black ....................................................................................................26
`
`Ormsby ................................................................................................28
`
`B. Claim 1: Neither Stolz, Black, or Ormsby Disclose, Teach or Suggest an
`Assembly “Wherein the Non-Conductive Material is Thermally Fused With
`the Lead Body From Heat Applied to the Lead Assembly”..........................30
`
`
`
`IPR No. 2018-00147
`Patent No. 8,650,747
`
`C. Claim 11: Neither Stolz, Ormsby, nor Black Disclose, Teach, or Suggest “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,” .................................................31
`
`D. Claims 2-10 and 12-19: The Cited References do not Render Dependent
`Claims 2-10 or 12-19 Obvious ......................................................................32
`
`E. Petitioner has not Identified a Sufficient Reason to Combine its Cited
`
`References.............................................................................................................36
`
`1.
`
`2.
`
`Stolz Discloses That its Multi-lumen Lead Body Addresses the
`Alleged Advantages Conferred by Ormsby’s Back-Fill .....................36
`
`The Alleged Reasons to Modify Stolz Using Black are Already
`Addressed by Stolz ..............................................................................43
`
`VIII. RESERVATION OF RIGHTS ...................................................................... 44
`
`
`
`TABLE OF AUTHORITIES
`
`IPR No. 2018-00147
`Patent No. 8,650,747
`
`Agrinomix, LLC v. Mitchell Ellis Products, Inc.,
`IPR2017-00525, Paper 8, (P.T.A.B. Jun. 14, 2017) ............... 17, 20, 30
`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
`CFMT, Inc. v. YieldUp Int’l Corp.,
`349 F.3d 1333 (Fed. Cir. 2003) ..................................................... 21
`DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc.,
`567 F.3d 1314 (Fed. Cir. 2009) .......................................................... 21
`Graham v. John Deere Co.,
`383 U.S. 1 (1966) ................................................................................ 20
`In re Kahn,
`441 F.3d 977 (Fed. Cir. 2006) ............................................................ 21
`In re Rijckaert,
`9 F.3d 1531 (Fed. Cir. 1993) ......................................................... 21
`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 Servs., LLC v. Greene’s Energy Grp., LLC,
`639 F. App’x 639 (Fed. Cir. 2016) ..................................................... 44
`Pers. Web Techs., LLC v. Apple, Inc.,
`848 F.3d 987 (Fed. Cir. 2017) ............................................................ 22
`St. Jude Med., Inc. v. Access Closure, Inc.,
`729 F.3d 1369 (Fed. Cir. 2013) ............................................... 20, 21
`Trivascular, Inc. v. Samuels,
`812 F. 3d 1056 (Fed. Cir. 2016) ......................................................... 39
`
`
`
`I.
`
`STATEMENT OF PRECISE RELIEF REQUESTED
`
`On November 2, 2017, Nevro Corp. (“Petitioner”) submitted a Petition for
`
`Inter Partes Review (“Petition”) challenging claims 1-19 (“Challenged Claims”) of
`
`U.S. Patent No. 8,650,747 (“the ’747 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 systems (SCS), 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 ’747 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-
`
`
`
`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 fusion
`
`between material from the lead body and the non-conductive material within the
`
`conductor lumens. Stolz, Black, and Ormsby do not disclose, teach or suggest
`
`assemblies for manufacturing SCS leads employing these features.
`
`First, Stolz, Black, and Ormsby fail to disclose “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,” as required
`
`by Claims 1-10, or “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,” as required by Claims 11-19. None of
`
`these references disclose the use of a solid, non-conductive material to fill an
`
`empty portion of a conductor lumen prior to a thermal reflow step.
`
`Second, none of the cited references discloses, teaches or suggests the
`
`limitation “wherein the non-conductive material is thermally fused with the lead
`
`body from heat applied to the lead assembly,” as required by claims 1-10 and 12,
`
`or the limitation “wherein the spacers and the non-conductive material are
`
`thermally fused together” as required by claim 14. Because none of the references
`
`discloses, teaches or suggests the placement of non-conductive material in
`
`-2-
`
`
`
`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 Ground 1. 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 Ground 1. 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.
`
`The Petition thus fails to establish by a preponderance of the evidence that
`
`Petitioner is reasonably likely to demonstrate that any of Claims 1-19 is
`
`unpatentable. Institution should be denied as to the sole ground of the Petition.
`
`-3-
`
`
`
`III. THE ’747 PATENT
`
`The ’747 Patent is titled “Electrode Array Assembly and Method of Making
`
`Same.” The ’747 Patent discloses and claims assemblies for the manufacture of
`
`stimulation leads for use in a spinal cord stimulation system (SCS). 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 ’747 Patent shows this arraignment:
`
`-4-
`
`
`
`Prior art methods of constructing leads, and the assemblies therein, had both
`
`reliability and cost limitations because manufacturing multi-contact, percutaneous
`
`stimulation leads is an involved process. As the ’747 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.)
`
`The ’747 Patent addresses this need by disclosing unique assemblies for use
`
`in manufacturing SCS leads in efficiently and reliably. These assemblies include
`
`several key features that are found in independent claim 11, the broadest claim in
`
`the Patent:
`
`11. A stimulation lead assembly for making a lead, the assembly
`
`comprising:
`
`[a11] 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;
`
`[b11] 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;
`
`-5-
`
`
`
`[c11] a plurality of conductor wires disposed in the conductor
`
`lumens, wherein at least one of the conductor wires is electrically
`
`connected to each conductive contact; and
`
`[d11] 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.
`
`These claim features are illustrated, for an exemplary lead and lead
`
`assembly, in figures 5A, 5B, and 6A of the ’747 Patent. Figures 5A and 5B show,
`
`in an exemplary lead, the limitations found in element [a11]:
`
`The figures show eight conductor lumens, identified as element 116, which 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 [c11]. (Id.)
`
`-6-
`
`
`
`The remaining elements of claim 11 are shown, in exemplary fashion, in
`
`figure 6A, which shows a cross section of an end of a stimulation lead assembly:
`
`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 [b11]. The conductor wires are connected to the contacts on a
`
`one-to-one basis via welds shown in red, per element [c11]. Finally, a solid, non-
`
`conductive material highlighted in blue is shown disposed radially underneath the
`
`conductive contacts within portions of the conductor lumens not occupied by
`
`conductor wire, per element [d11].
`
`Independent claim 1 is narrower than claim 11:
`
`-7-
`
`
`
`1. A stimulation lead assembly for making a lead, the assembly
`
`comprising:
`
`[a1] 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;
`
`[b1] 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;
`
`[c1] 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
`
`[d1] 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;
`
`[e1] wherein the non-conductive material is thermally fused with the
`
`lead body from heat applied to the lead assembly, which heat is at a
`
`-8-
`
`
`
`temperature to cause the nonconductive material to thermally reflow
`
`or melt.
`
`Claim 1 imposes additional restrictions on elements [c11] and [d11]:
`
`element [c1] is narrower, requiring that the conductor lumens must also
`
`“comprise[] 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.”
`
`The non-conductive material must then fill that unoccupied portion per element
`
`[d1]. Claim 1 also requires an additional thermal fusion step [e1] wherein the non-
`
`conductive material is thermally fused with the lead body using an appropriate
`
`amount of heat. An exemplary thermal fusion step is illustrated in figure 6B of the
`
`’747 Patent:
`
`-9-
`
`
`
`(Ex. 1001 at 6:11-25.) After the appropriate application of heat, the non-
`
`conductive material, in this embodiment a monofilament (60), 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 combination of elements, as claimed in independent claims 1
`
`and 11, constitute lead assemblies that can used to reliably manufacture leads in a
`
`quick and efficient manner. Further, as detailed below, these elements were not
`
`present in the prior art.
`
`-10-
`
`
`
`IV. THE ASSERTED REFERENCES
`
`A.
`
`Stolz
`
`Stolz was before the patent Examiner during the prosecution of the ’747
`
`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 ’747 Patent and marked with an asterisk, indicating that they were cited by
`
`the Examiner during prosecution. (Ex. 1001 at pp. 1-2.)
`
`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-
`
`
`
`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-
`
`
`
`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 and acknowledged by the Petitioner, 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-
`
`
`
`Stolz does not disclose any of the following: assemblies for manufacturing
`
`stimulation leads; 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; thermal fusion between the non-conductive
`
`material and the lead body; 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.
`
`-14-
`
`
`
`(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
`
`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 ’747 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 “a lead body
`
`defining a central lumen extending along the lead body and a plurality of conductor
`
`lumens disposed circumferentially around the central lumen,” “a portion of each of
`
`the conductor lumens . . . disposed radially underneath the conductive contacts,” or
`
`“a solid, non-conductive material disposed, at least in part, radially underneath the
`
`-15-
`
`
`
`conductive contacts and filling the unoccupied portion of at least one of the
`
`conductor lumens.” (See Ex. 1002 at 47-49.) The Examiner then allowed the
`
`claims. (See Ex. 1002 at 17.)
`
`Nevertheless, Petitioner argues the “[e]xaminer’s failure 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 1 and 12 of the ’747
`
`Patent contain a thermal reflow limitation that is independent from the non-
`
`conductive material limitation. And, the insertion of the non-conductive material
`
`is a predicate for the subsequent limitation requiring that “the non-conductive
`
`material [be] 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.” Black’s disclosure of spacer material that is reflowed as
`
`a consequence of heat transfer during over-molding thus cannot constitute the
`
`“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” within the meaning of claim 1 of the ’747 Patent. Furthermore,
`
`as the Petitioner concedes, the Examiner found a coextensive disclosure elsewhere
`
`-16-
`
`
`
`in the prior art and the thermal flow limitation was not relied on by the Examiner
`
`to distinguish Black, Stolz, and the other prior art of record. (Petition 17-18.)
`
`Thus, Petitioner does no more than re-present Black in “the same substantive
`
`manner as Petitioner now advocates,” and the Board may “decline to institute inter
`
`partes review on those grounds . . . .” See Agrinomix at 11-12.
`
`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 they 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
`
`-17-
`
`
`
`flexible tip with properties similar to prior art ultrasonic systems. Ormsby
`
`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 distal end is transmitted to the proximal 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 assemblies 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; an occupied portion in each conductor lumen within which at
`
`least one of the conductor wires is disposed and an unoccupied portion in each
`
`conductor lumen in which none of the conductor wires is disposed, the unoccupied
`
`portion extending from an end of the conductor lumen; 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; thermal
`
`fusion between the non-conductive material and the lead body; or selecting exactly
`
`eight conductor lumens. In addition, the Petition fails to establish that one skilled
`
`-18-
`
`
`
`in the art would have consulted Ormsby when determining how to make spinal
`
`stimulation 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 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
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`surrounding tissue. (Ex. 1006 at 7:27-8:6.) Ormsby’s guidewire is therefore not
`
`intended for “stimulation,” as claims 1 and 11 require. The Petition utterly fails to
`
`acknowledge this difference, much less provide any explanation for why a POSA
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`would look to Ormsby in light of the different nature of their intended use.
`
`The Petition’s accompanying expert declaration fails to remedy theses
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`deficiency, as it merely relies on the Petitioner’s counsel for the assertion that
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`Ormsby qualifies as prior art and does not explain why one skilled in the art would
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`have consulted imaging guidewires when designing SCS leads. (See Ex. 1003 ¶¶
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`89-90.)
`
`-19-
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`
`
`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
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`substantially the same prior art or arguments previously were presented to the
`
`Office.” 35 U.S.C. § 325(d); Agrinomix, LLC v. Mitchell Ellis Products, Inc.,
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`IPR2017-00525, Paper 8, at 10 (P.T.A.B. Jun. 14, 2017). Where a reference “was
`
`previously presented to, and considered by, the Office in the same substantive
`
`manner as Petitioner now advocates,” the Office has discretion to “decline to
`
`institute inter partes review on those grounds . . . .” Agrinomix at 11-12. This
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`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
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`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.,
`
`-20-
`
`
`
`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
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`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
`
`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
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`(Fed. Cir. 2006); see InTouch Techs., Inc. v. VGO Commc’ns, Inc., 751 F.3d 1327,
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`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 1064,
`
`1073 (Fed. Cir. 2015); DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567
`
`F.3d 1314, 1326 (Fed. Cir. 2009) (“Although predictability is a touchstone of
`
`-21-
`
`
`
`obviousness, the ‘predictable result’ discussed in KSR refers not only to the
`
`expectation that prior art elements are capable of being physically combined, but
`
`also that the combination would have worked for its intended purpose”). Thus,
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`Petitioner must present a “clear, evidence-supported account of the contemplated
`
`workings of the combination.” Pers. Web Techs., LLC v. Apple, Inc., 848 F.3d
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`987, 994 (Fed. Cir. 2017).
`
`Where each of the references of a purported combination “independently
`
`accomplish similar functions” and “operate[] effectively” to achieve their
`
`purposes, a POSA may have no reason to combine the features of those
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`references. Kinetic Concepts, 688 F.3d at 1369; Broadcom Corp. v. Emulex
`
`Corp., 732 F.3d 1325, 1334 (Fed. Cir. 2013) (“[the prior art reference’s] task and
`
`purpose was to recover the clock data and to phase synchronize the signal—[its]
`
`system accomplished its objective and provided no suggestion to broaden that
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`objective.”
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