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. 2018-00143
`U.S. Patent No. 7,891,085
`
`PATENT OWNER’S PRELIMINARY RESPONSE
`
`

`

`TABLE OF CONTENTS
`
`IPR No. 2018-00143
`Patent No. 7,891,085
`
`Page
`
`I.
`
`II.
`
`III.
`
`IV.
`
`STATEMENT OF PRECISE RELIEF REQUESTED ................................... 1
`
`INTRODUCTION ........................................................................................... 1
`
`THE ’085 PATENT ......................................................................................... 4
`
`THE ASSERTED REFERENCES ................................................................10
`
`A.
`
`B.
`
`C.
`
`Stolz .....................................................................................................10
`
`Black ....................................................................................................12
`
`Ormsby ................................................................................................15
`
`D. Wessman .............................................................................................18
`
`E.
`
`Saab .....................................................................................................19
`
`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 1-3, 6-12, OR
`14-17 ..............................................................................................................23
`
`A.
`
`Claim 1: Neither Stolz, Ormsby nor Black Discloses, Teaches or
`Suggests “Inserting Monofilament Into at Least one Portion of at
`Least one of the Conductor Lumens of the Lead Body that is not
`Occupied by the Conductor Wires” ....................................................23
`
`1.
`
`2.
`
`3.
`
`Stolz...........................................................................................24
`
`Black .........................................................................................25
`
`Ormsby ......................................................................................27
`
`B.
`
`Claim 1: Neither Stolz, Black or Ormsby Discloses, Teaches or
`Suggests “Heating the Spacers and Monofilament to a Temperature
`
`

`

`C.
`
`D.
`
`E.
`
`F.
`
`IPR No. 2018-00143
`Patent No. 7,891,085
`to Cause Thermal Flow or Melting of at Least one of the Spacers or
`Monofilament” ....................................................................................28
`
`Claims 2-3, 6-12, and 14-17: The Cited References do not Render
`Dependent Claims 2-3, 6-12, and 14-17 Obvious. ..............................30
`
`Claims 3, 11-12, 17: The Cited References do not Render
`Dependent Claims 3, 11-12, and 17 Obvious. ....................................31
`
`Claim 7: The Petition Fails to Establish that Stolz’s “Conductive
`Contacts are in the Form of Rings” .....................................................31
`
`Petitioner has not Identified a Sufficient Reason to Combine its
`Cited References ..................................................................................32
`
`1.
`
`2.
`
`3.
`
`Stolz Discloses That its Multi-lumen Lead Body Addresses
`the Alleged Advantages Conferred by Ormsby’s Back-Fill .....32
`
`The Alleged Reasons to Modify Stolz Using Black are
`Already Addressed by Stolz ......................................................38
`
`The Petition Fails to Establish That a POSA Would
`Substitute Monofilament for the Non-Conductive Materials
`Disclosed in the Prior Art .........................................................39
`
`VIII. GROUND 2: THE COMBINATION OF STOLZ, ORMSBY, BLACK,
`AND THE MODERN PLASTICS ENCYCLOPEDIA DOES NOT
`RENDER OBVIOUS CLAIMS 4, 5, OR 13 OF THE ’085 PATENT .........43
`
`A.
`
`B.
`
`Claims 4, 5, and 13: The Cited References do not Render
`Dependent Claims 4, 5, and 13 Obvious Because They Do Not
`Render Independent Claim 1 Obvious. ...............................................43
`
`Claims 4, 5, and 13: The Modern Plastics Encyclopedia Fails to
`Supply Missing Elements of Claims 4, 5, and 13. ..............................44
`
`IX. GROUND III: THE COMBINATION OF STOLZ, ORMSBY, BLACK,
`AND WESSMAN DOES NOT RENDER OBVIOUS CLAIM 18 OF
`THE ’085 PATENT .......................................................................................46
`
`A.
`
`Claim 18: The Cited References do not Render Dependent Claim
`18 Obvious. .........................................................................................46
`
`ii
`
`

`

`X.
`
`IPR No. 2018-00143
`Patent No. 7,891,085
`GROUND IV: THE COMBINATION OF STOLZ, ORMSBY, BLACK,
`WESSMAN, AND SAAB DOES NOT RENDER OBVIOUS CLAIM 19
`OF THE ’085 PATENT .................................................................................47
`
`A.
`
`Claim 19: The Cited References do not Render Dependent Claim
`19 Obvious. .........................................................................................47
`
`XI. RESERVATION OF RIGHTS ......................................................................49
`
`iii
`
`

`

`TABLE OF AUTHORITIES
`
`IPR No. 2018-00143
`Patent No. 7,891,085
`
`Agrinomix, LLC v. Mitchell Ellis Products, Inc.,
`IPR2017-00525, Paper 8, (P.T.A.B. Jun. 14, 2017) ........................... 20
`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) ..................................................... 21
`DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc.,
`567 F.3d 1314 (Fed. Cir. 2009) .......................................................... 22
`Graham v. John Deere Co.,
`383 U.S. 1 (1966) ................................................................................ 21
`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, 22
`Kinetic Concepts, Inc. v. Smith & Nephew, Inc.,
`688 F.3d 1342 (Fed. Cir. 2012) .............................................. 21, 22, 23
`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), cert. granted, 137 S. Ct. 2239 (2017)
` ............................................................................................................ 49
`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) ..................................................... 21
`Trivascular, Inc. v. Samuels,
`812 F. 3d 1056 (Fed. Cir. 2016) ......................................................... 34
`
`iv
`
`

`

`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. 7,891,085 (“the ’085 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. Patent Owner therefore
`
`respectfully requests that institution be denied on all Grounds and with respect to
`
`each claim of the ’085 Patent.
`
`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 ’085 Patent combines
`
`several lead features into a process that is especially useful for the manufacture of
`
`-1-
`
`

`

`SCS leads. These features include a multi-lumen body with conductor lumens
`
`arranged around a central stylet lumen, the use of multiple contacts and non-
`
`conductive spacers that fit radially over the conductor lumens at the end of the lead
`
`assembly, the use of monofilament material disposed within those conductor
`
`lumens in portions unoccupied by conductor wires, and reflowing either the
`
`spacers or monofilament by heating both materials. The dependent claims add
`
`limitations regarding the precise heat and time parameters for use during the reflow
`
`process.
`
`Stolz, in combination with either Black and Ormsby (Ground 1) does not
`
`disclose, teach, or suggest a method for manufacturing SCS leads employing these
`
`features, and neither the Modern Plastics Encyclopedia (Ground 2), Wessman
`
`(Ground 3), nor Saab (Ground 4) supplements these teachings to arrive at the
`
`claimed invention.
`
`First, Stolz, Black, and Ormsby fail to disclose, teach, or suggest “inserting
`
`monofilament into at least one portion of at least one of the conductor lumens of
`
`the lead body that is not occupied by the conductor wires” as required by
`
`independent claims 1 and its dependent claims 2-19. None of these references
`
`disclose, teach, or suggest the use of monofilament for any purpose, much less as
`
`material to fill an empty portion of a conductor lumen prior to a thermal reflow
`
`step.
`
`-2-
`
`

`

`Second, none of the cited references disclose, teach, or suggest the limitation
`
`“reflowing at least one of the spacers or monofilament into at least one portion of
`
`at least one of the conductor lumens not occupied by the conductive wires by
`
`heating the spacers and monofilament to a temperature to cause thermal flow or
`
`melting of at least one of the spacers or monofilament,” as required by claims 1-19.
`
`Because none of the references disclose, teach, or suggest the placement of
`
`monofilament in unoccupied portions of the conductor lumens, none of them teach
`
`or suggest heating that monofilament in conjunction with spacers.
`
`Third, Petitioner has not demonstrated a legally sufficient motivation to
`
`combine the asserted references. A POSA would not have been motivated to
`
`modify Stolz for the reasons offered by the Petitioner because a POSA would have
`
`understood that Stolz’s body design did not result in large empty sections in
`
`portions of conductor lumens in a lead body containing multiple conductor lumens.
`
`Accordingly, a POSA would not have been motivated to apply a thermal reflow
`
`step from Black or place Ormsby’s non-conductive material in Stolz’s conductor
`
`lumens.
`
`Ormsby discloses an ultrasound guidewire with a multiple-wire-filled body
`
`that is subject to stresses during use. The stresses experienced by Ormsby’s
`
`ultrasound guidewire are far different from those experienced by an SCS lead, and
`
`Petitioners have not demonstrated a reasonable likelihood that a POSA would have
`
`-3-
`
`

`

`thought it necessary to address kink resistance in an unfilled portion of a small
`
`conductor lumen at the proximal or distal end of a lead. Nor has Petitioner shown
`
`a reasonable likelihood that one skilled in the art would have had any reason to
`
`apply Black’s use of fill to support contacts to Stolz. Unlike Stolz, Black discloses
`
`a lead with a single conductor-lumen design. Stolz would have no need to use
`
`Black’s fill because the material already surrounding the conductor lumens in
`
`Stolz’s multi-conductor lumen body provides axial stability to the lead.
`
`Petitioner’s proposed combination therefore creates redundancies that would serve
`
`no purpose other than hindsight reconstruction of the invention, and would—
`
`contrary to the objective of the ’085 Patent inventors—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 the Challenged Claims
`
`are unpatentable. Institution should be denied as to all grounds.
`
`III. THE ’085 PATENT
`
`The ’085 Patent is titled “Electrode Array Assembly and Method of Making
`
`Same.” The ’085 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
`
`-4-
`
`

`

`epidurally in close proximity to a patient’s spine. (Ex. 1001 at 3:42-53; 4:6-12.)
`
`Figure 2 of the ’085 Patent shows this arraignment:
`
`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 ’085 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
`
`-5-
`
`

`

`percutaneous lead in order to improve its performance and to improve the method
`
`of manufacturing the lead.” (Ex. 1001 at 1:63-2:3.)
`
`The ’085 Patent addresses this need by disclosing unique assembly
`
`procedures for use in manufacturing SCS leads in an efficient and reliable manner.
`
`These procedures include several key features that are found in independent claim
`
`1, the only independent claim in the Patent:
`
`1. A method of manufacturing a stimulation lead having a proximal
`
`end and a distal end, comprising:
`
`[a1] providing a plurality of conductive contacts located at an end of
`
`a lead body of the stimulation lead;
`
`[b1] disposing a plurality of conductor wires in a plurality of
`
`conductor lumens formed in the lead body;
`
`[c1] connecting at least one of the plurality of conductor wires
`
`to each of the conductive contacts; and
`
`[d1] placing spacers between pairs of adjacent conductive contacts,
`
`wherein portions of the conductor lumens are located beneath the
`
`plurality of conductive contacts and the spacers;
`
`[e1] inserting monofilament into at least one portion of at least one of
`
`the conductor lumens of the lead body that is not occupied by the
`
`conductor wires; and
`
`-6-
`
`

`

`[f1] reflowing at least one of the spacers or monofilament into at least
`
`one portion of at least one of the conductor lumens not occupied by
`
`the conductive wires by heating the spacers and monofilament to a
`
`temperature to cause thermal flow or melting of at least one of the
`
`spacers or monofilament.
`
`These claim features are illustrated, for an exemplary lead produced by the
`
`claimed method, in figures 5A, 5B, 6A, and 6B of the ’085 Patent. Figures 5A and
`
`5B show, in an exemplary lead, the limitations found in element [b1]:
`
`The figures show the disposition of the conductor wires (element 122) within eight
`
`conductor lumens, identified as element 116. (Id.)
`
`Several 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-
`
`

`

`The conductive contacts (element 17 shown in green) are arranged along the end of
`
`the lead body, as required by limitation [a1]. The conductor wires, element (122)
`
`shown in yellow, are connected to the contacts on a one-to-one basis via welds
`
`shown in red, per claim limitation [c1]. Spacers, element 61, are distributed
`
`between the conductive contacts, as stated in element [d1]. Non-conductive
`
`monofilament (60) is disposed in portions of the conductor lumens of the lead body
`
`that is not occupied by the conductor wires per element [e1].
`
`-8-
`
`

`

`The final element of claim 1 requires a thermal fusion step [f1] wherein one
`
`of the spacers or monofilament is reflowed into at least one portion of at least one
`
`of the conductor lumens not occupied by the conductive wires by heating those two
`
`elements to a temperature at which at least one of them either melts or thermally
`
`flows. An exemplary thermal fusion step is illustrated in Figure 6B of the ’085
`
`Patent:
`
`(Ex. 1001 at 6:11-25.) After the appropriate application of heat, the monofilament
`
`(60) and/or the spacer material (61), flows into void spaces in the conductor
`
`lumens (70). This reflow step results in a matrix of material from the combined
`
`-9-
`
`

`

`spacer, monofilament, and lead body material. (Id.) In the manufacturing methods
`
`of dependent claims 18 and 19, heat shrink tubing (65) is used to contain material
`
`during the reflow step.
`
`The unique combination of elements, as claimed in the ’085 Patent,
`
`constitutes assembly procedures that can be used to reliably manufacture leads in a
`
`quick and efficient manner. Further, as detailed below, these elements were not
`
`present in the prior art.
`
`IV. THE ASSERTED REFERENCES
`
`A.
`
`Stolz
`
`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 (112), as shown
`
`in figure 13 of Stolz:
`
`-10-
`
`

`

`Stolz discloses that the coupling element (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” (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. (Id.) Stolz teaches that this
`
`-11-
`
`

`

`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 does not disclose, teach or suggest any of the following: inserting
`
`monofilament into conductor lumens, reflowing spacers or monofilament into
`
`portions of the conductor lumens, or using heat shrink tubing to manufacture leads.
`
`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, and Black’s disclosures are aimed at a manufacturing process for creating
`
`isodiametric leads. (Ex. 1008 at 1:22-32, 2:50-55.) 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.) The leads utilize a single conductor lumen surrounding a
`
`central stylet lumen.
`
`-12-
`
`

`

`(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.) This overmolding
`
`process helps create the isodiametric qualities that Black teaches are desirable. (Id.
`
`2:50-55.) 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.)
`
`-13-
`
`

`

`Black was discussed extensively during the prosecution of the ’085 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 teach or suggest the
`
`step of placing monofilament within at least a portion of at least one of a plurality
`
`of conductor lumens formed in a lead body.” (See Ex. 1002 at 56.) The Examiner
`
`then allowed the claims after a minor amendment to the ’085 Patent’s abstract.
`
`(See id. 56-57.)
`
`Nevertheless, Petitioner argues that the Examiner “did not appear to
`
`recognize” that Black discloses a thermal reflow step in which Black’s single
`
`conductor lumen is partially filled with spacer material. (Petition 23; 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 claim 1 of the ’085
`
`Patent contains a thermal reflow step that is independent from the step of inserting
`
`a monofilament in the relevant portion of the conductor lumen, i.e., into at least
`
`one portion of at least one of the conductor lumens of the lead body that is not
`
`occupied by the conductor wires. In addition, the thermal reflow step is performed
`
`on “at least one of the spacers or monofilament,” meaning that the thermal reflow
`
`step is performed on monofilament that has been inserted into at least a portion of
`
`at least one of the conductor lumens. Because the insertion of the monofilament is
`
`-14-
`
`

`

`a separate step and is a predicate for the subsequent step of “reflowing . . . by
`
`heating the spacers and monofilament,” Black’s reflowing step itself cannot
`
`constitute “inserting monofilament” within the meaning of claim 1 of the ’085
`
`Patent. Further, as the Petitioner concedes, the Examiner found a coextensive
`
`disclosure elsewhere in the prior art and the thermal flow limitation was not relied
`
`on by the Examiner to distinguish Black and the other prior art of record. (See
`
`Petition 22; Ex. 1002 at 69-70, 56-57.)
`
`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.)
`
`-15-
`
`

`

`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
`
`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. (Id. 7:4-10, 7:27-30.)
`
`Ormsby does not disclose, teach or suggest processes for manufacturing
`
`stimulation leads, providing a plurality of conductive contacts at the end of a
`
`stimulation lead, disposing a plurality of conductor wires in a plurality of
`
`conductor lumens formed in a stimulation lead body, placing spacers between
`
`conductive contacts, inserting monofilament into unoccupied portions of conductor
`
`lumens in the lead body, or the use of thermal flow techniques. In addition, the
`
`Petition fails to establish that one skilled in the art would have consulted Ormsby
`
`when determining how to make spinal stimulation leads. The Petition relies on
`
`-16-
`
`

`

`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.)
`
`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
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`section III, deliver electrical stimulation to a patient’s spine. Ormsby’s guidewire,
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`by contrast, uses an ultrasonic transducer to emit ultrasonic energy and then uses
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`the reflected ultrasonic echoes to create an image of the surrounding tissue. (Ex.
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`1006 at 7:27-8:6.) Ormsby’s guidewire is therefore not intended for “stimulation,”
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`as claims 1 and 11 require. The Petition utterly fails to acknowledge this
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`difference, much less provide any explanation for why a POSA would look to
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`Ormsby in light of the different nature of their intended use.
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`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.)
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`-17-
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`

`

`D. Wessman
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`Wessman is directed at methods of manufacturing lead bodies in which the
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`conductors are well insulated from one another. Wessman achieves this through a
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`method for manufacturing a lead body in which one or more conductors are
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`sandwiched between inner and outer insulation layers, as shown in figure 1A:
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`(Ex. 1009.) The conductor element (16) is sandwiched between an inner insulation
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`layer (14) and an outer insulation layer (18). (Id. ¶ 21.) Once the conductors have
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`been suitably wound around the inner insulation layer and the outer layer is placed
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`over that assembly, the outer and inner layers are fused to one another by heating
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`the lead body or the outer insulator. (Id. ¶ 24.) In some limitations, a heat-shrink
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`wrapper is used to surround the lead body during the bonding of one insulation
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`layer to another.
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`-18-
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`

`

`Wessman does not disclose, teach or suggest providing a plurality of
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`conductive contacts at the end of a stimulation lead, disposing a plurality of
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`conductor wires in a plurality of conductor lumens formed in a stimulation lead
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`body, placing spacers between conductive contacts, inserting monofilament into
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`unoccupied portions of conductor lumens in the lead body, or the use of heat-
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`shrink tubing in conjunction with conductive contacts, spacers, or monofilament.
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`E.
`
`Saab
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`Saab discloses general advice regarding the use of heat shrink tubing in the
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`construction of medical devices. Saab discloses that heat shrink tubing can be used
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`as the outer wall of some medical catheters, (Ex. 1011 at 56) as well as for
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`electrical insulation, smoothing rough edges, preventing kinking in braided
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`catheters, joining tubes with different mechanical properties, and forming a
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`smooth, tapered tip at the end of a catheter. (Id. at 57-59.) Saab also discloses
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`using heat shrink tubing as a masking material during the coating of a part. (Id. at
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`61-62.)
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`Saab does not disclose, teach or suggest methods for manufacturing
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`stimulation leads, providing a plurality of conductive contacts at the end of a
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`stimulation lead, disposing a plurality of conductor wires in a plurality of
`
`conductor lumens formed in a stimulation lead body, placing spacers between
`
`conductive contacts, inserting monofilament into unoccupied portions of conductor
`
`-19-
`
`

`

`lumens in the lead body, the use of thermal flow techniques methods of
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`manufacturing stimulation leads, the use of heat-shrink tubing in conjunction with
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`conductive contacts or as a method of containing parts or guiding plastic flow
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`during thermal reflow.
`
`V.
`
`STATEMENT OF THE LAW
`In determining whether to institute an Inter Partes Review, the PTO may
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`“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
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`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
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`previously presented to, and considered by, the Office in the same substantive
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`manner as Petitioner now advocates,” the Office has discretion to “decline to
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`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
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`to be heard against the interests of patent owners, who seek to avoid harassment.”
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`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;
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`(ii) the level of ordinary skill in the art; (iii) the differences between the claimed
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`invention and the prior art; and (iv) secondary considerations of nonobviousness,
`
`-20-
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`

`

`such as commercial success, long-felt need, and the failure of others. KSR Int’l
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`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
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`disclosed in prior art references. See St. Jude Med., Inc. v. Access Closure, Inc.,
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`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.
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`1993).
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`However, “a patent . . . is not proved obvious merely by demonstrating
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`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
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`carefully guarded against. Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688
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`F.3d 1342, 1368 (Fed. Cir. 2012). Thus, it is “important to identify a reason that
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`would have prompted a person of ordinary skill in the relevant field to combine
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`the elements in the way the claimed new invention does.” KSR Int’l Co., 550 U.S.
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`at 418. The rationale must be more than “mere conclusory statements; instead,
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`there must be some articulated reasoning with some rational underpinning to
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`support the legal conclusion of obviousness.” In re Ka