throbber
Case 1:16-cv-01163-CFC-CJB Document 215 Filed 03/16/18 Page 1 of 27 PageID #: 6673
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`BOSTON SCIENTIFIC CORP. and
`BOSTON SCIENTIFIC
`NEUROMODULATION CORP.,
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`C.A. No. 16-1163-GMS
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`
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`
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`
`
`Plaintiffs,
`
`v.
`
`Defendant.
`
`
`
`
`NEVRO CORP.,
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`
`
`
`
`CORRECTED PLAINTIFFS’ ANSWERING BRIEF
`IN OPPOSITION TO NEVRO CORP.’S MOTION FOR LEAVE TO AMEND ITS
`ANSWER TO ASSERT AN AFFIRMATIVE DEFENSE AND COUNTERCLAIM OF
`UNENFORCEABILITY DUE TO INEQUITABLE CONDUCT
`
`
`OF COUNSEL:
`
`Matthew M. Wolf
`Edward Han
`Marc A. Cohn
`William Z. Louden
`ARNOLD & PORTER KAYE SCHOLER LLP
`601 Massachusetts Ave., NW
`Washington, DC 20001-3743
`(202) 942-5000
`matthew.wolf@arnoldporter.com
`ed.han@arnoldporter.com
`marc.cohn@arnoldporter.com
`william.louden@arnoldporter.com
`
`Krista M. Carter
`Edmond K. Ahadome
`ARNOLD & PORTER KAYE SCHOLER LLP
`3000 El Camino Real
`Five Palo Alto Square | Suite 500
`Palo Alto, CA 94306-2112
`(650) 319-4500
`krista.carter@arnoldporter.com
`edmond.ahadome@arnoldporter.com
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`01:22959293.1
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`
`
`Karen L. Pascale (#2903)
`Pilar G. Kraman (#5199)
`YOUNG CONAWAY STARGATT & TAYLOR, LLP
`Rodney Square
`1000 North King Street
`Wilmington, Delaware 19801
`(302) 571-6600
`kpascale@ycst.com
`pkraman@ycst.com
`
`Attorneys for Plaintiffs Boston Scientific
`Corporation and Boston Scientific
`Neuromodulation Corp.
`
`March 16, 2018
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`

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`Case 1:16-cv-01163-CFC-CJB Document 215 Filed 03/16/18 Page 2 of 27 PageID #: 6674
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`
`
`I.
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`II.
`
`III.
`
`IV.
`
`TABLE OF CONTENTS
`
`INTRODUCTION ...............................................................................................................1
`
`NATURE OF THE PROCEEDINGS ..................................................................................2
`
`SUMMARY OF THE ARGUMENT ..................................................................................2
`
`STATEMENT OF THE FACTS .........................................................................................3
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`The Pioneering Inventions Claimed in the ’280 Patent .......................................... 3
`
`BSC Secured Patents By Claiming a Novel SCS System, Not By Contending that
`Rechargeable Batteries Were Unknown ................................................................. 4
`
`BSC Prevailed in the IPR by Demonstrating that the Challenged Claims were
`Not Obvious Over the References Nevro Cited ...................................................... 7
`
`Nevro Misrepresents the Parties’ Meet and Confers Regarding the
`Confidentiality Designation of Mr. Meadows’ Transcript ..................................... 9
`
`Nevro Failed to Take Discovery on a Potential Inequitable Conduct Claim
`Before the Deadline to Amend ............................................................................. 10
`
`V.
`
`ARGUMENT .....................................................................................................................11
`
`A.
`
`B.
`
`C.
`
`Legal Standards ..................................................................................................... 11
`
`Nevro Cannot Show Good Cause for Granting Leave to Amend ......................... 13
`
`Even if Good Cause Did Exist (Which It Does Not), the Court Should
`Exercise Its Discretion to Deny Leave to Amend ................................................. 15
`
`1.
`
`2.
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`3.
`
`4.
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`Nevro’s Allegations Against Mr. Gold and the Inventors Are Futile
`Because They Do Not Show Materiality or Intent to Deceive ................. 15
`
`Nevro’s Allegations Concerning the IPR are Futile Because They
`Fail to Show that BSC Made Any False Statements or Prevented the
`Board from Receiving Material Evidence ................................................ 18
`
`Nevro’s Amendment Is Unduly Delayed and in Bad Faith ...................... 19
`
`Nevro’s Belated Amendment Would Unfairly Prejudice BSC ................. 20
`
`VI.
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`CONCLUSION ..................................................................................................................20
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`TABLE OF AUTHORITIES
`
`Cases
`Abaxis, Inc. v. Cepheid,
`No. 10-CV-02840-LHK, 2011 WL 3741501 (N.D. Cal. Aug. 25, 2011) ........................... 15, 16
`Adv. Cardiovascular Sys., Inc. v. SciMed Life Sys., Inc.,
`989 F. Supp. 1237 (N.D. Cal. 1997) ......................................................................................... 14
`Adv. Neuromod. Systems, Inc. v. Adv. Bionics Corp.,
`E.D.T.X. No. 4:04cv131, Docket No. 284 ................................................................................ 11
`Am. Calcar, Inc. v. Am. Honda Motor Co.,
`768 F.3d 1185 (Fed. Cir. 2014) ................................................................................................ 16
`Apotex Inc. v. UCB, Inc.,
`763 F.3d 1354 (Fed. Cir. 2014) ................................................................................................ 16
`Asahi Glas Co. v. Guardian Indus. Corp.,
`276 F.R.D. 417 (D. Del. 2011) ................................................................................................. 14
`Benihana of Tokyo Inc. v. Benihana Inc.,
`No. 10-1051-SLR, 2011 WL 3861897 (D. Del. Sep. 1, 2011) ................................................. 13
`Biovail Labs. Int’l SRL v. Andrx Pharms., LLC,
`No. 05-586-GMS, D.I. 177 (D. Del. May 4, 2007) .................................................................. 14
`Carman Indus., Inc. v. Wahl,
`724 F.2d 932 (Fed. Cir. 1983) .................................................................................................... 4
`Cornell University v. Illumina, Inc.,
`No. 10-433-LPS-MPT, 2017 WL 89165 (D. Del. Jan. 10, 2017) ............................................. 17
`Depomed, Inc. v. Purdue Pharama L.P.,
`No. 13-571 (MLC), 2017 WL 2804953 (D.N.J. June 28, 2017) .............................................. 19
`E. Minerals & Chems. Co. v. Mahan,
`225 F.3d 330 (3d Cir. 2000) ..................................................................................................... 12
`EMC Corp. v. Zerto, Inc.,
`12-956-GMS, 2014 WL 3809365 (D. Del. July 31, 2014) ....................................................... 19
`Enzo Life Scis., Inc. v. Digene Corp.,
`270 F. Supp. 2d 484 (D. Del. 2003) .................................................................................... 12, 14
`Exergen Corp. v. Wal-Mart Stores, Inc.,
`575 F.3d 1312 (Fed. Cir. 2009) .......................................................................................... 11, 16
`Foman v. Davis,
`371 U.S. 178 (1962) .................................................................................................................. 12
`Lazare Kaplan Int’l, Inc. v. Photoscribe Techs., Inc.,
`628 F.3d 1359 (Fed. Cir. 2010) ................................................................................................ 17
`MagSil Corp. v. Seagate Tech.,
`No. 08-940, 2010 WL 2710472 (D. Del. July 7, 2010) ............................................................ 14
`
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`Case 1:16-cv-01163-CFC-CJB Document 215 Filed 03/16/18 Page 4 of 27 PageID #: 6676
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`Nevro Corp. v. Boston Scientific Corp.,
`No. 16-cv-06830-VC, D.I. 172, (N.D. Cal. Aug. 3, 2017) ....................................................... 18
`Nevro Corp. v. Boston Scientific Corp.,
`No. 16-cv-06830-VC, D.I. 187 (N.D. Cal. Oct. 4, 2017) ......................................................... 18
`Regeneron Pharm., Inc. v. Merus N.V.,
`864 F.3d 1343 (Fed. Cir. 2017) .......................................................................................... 12, 19
`Senju Pharm. Co. v. Apotex, Inc.,
`921 F. Supp. 2d 297 (D. Del. 2013) .......................................................................................... 13
`Sonos, Inc. v. D&M Holdings, Inc.,
`No. 14-1330-RGA, 2017 WL 476279 (D. Del. Feb. 3, 2017) ............................................ 12, 13
`Therasense, Inc. v. Becton, Dickinson & Co.,
`649 F.3d 1276 (Fed. Cir. 2011) .................................................................................... 12, 16, 20
`M-B-W, Inc. v. Multiquip, Inc.,
`756 F. Supp. 2d 1034 (E.D. Wis. 2010) ................................................................................... 16
`
`
`Federal Statutes
`
`Fed. R. Civ. P. 15(a) ....................................................................................................................... 2
`Fed. R. Civ. P. 16(b) ................................................................................................................. 2, 12
`
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`I.
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`INTRODUCTION
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`In a last ditch effort to deflect from the merits of BSC’s patent infringement case against
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`it, Nevro belatedly moves to amend to add an affirmative defense and counterclaims of
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`inequitable conduct that are not grounded in law or fact.
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`Nevro’s allegations concern the conduct of BSC’s prosecution and litigation counsel
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`during the prosecution and an Inter Partes Review (“IPR”) proceeding relating to U.S. Patent No.
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`6,895,280 (“’280 Patent”), one of BSC’s foundational patents directed to a novel spinal cord
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`stimulation (“SCS”) system. In both instances, the issue before the Patent Office was whether a
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`specific reference disclosed limitations of the claimed inventions. BSC distinguished its claims
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`by demonstrating that those references lacked a required limitation. Nevro’s contentions here
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`however, rest entirely on allegations that BSC failed to inform the Patent Office of what was
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`generally known in the art. As the Patent Trial and Appeal Board (the “Board”) recently
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`reminded Nevro in denying a petition for rehearing in the IPR at issue here,1 “[t]he mere fact that
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`a feature may have been well-known in the prior art is insufficient to establish that it was present
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`in a specific prior art reference.” Ex. A at 4-5.2 In any event, in each proceeding, BSC disclosed
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`and the Patent Office was fully aware of what was known in the art. Because there can be no
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`inference of materiality or intent, Nevro’s proposed claims are futile.
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`Moreover, Nevro offers no justification for filing its motion more than three months after
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`the deadline to amend, nor can it. Its proposed pleadings are based on information that has been
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`in the public record for years, and it delayed in noticing the depositions of the inventors and the
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`
`1 Nevro has filed three IPR petitions challenging certain claims of the ’280 Patent, one of which
`is relevant to the present motion: IPR No. 2017-01811 (“the 1811 IPR”), filed on July 21, 2017.
`D.I. 194, Ex. A.
`2 Exhibits are attached to the Declaration of Karen L. Pascale filed concurrently herewith.
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`prosecuting attorneys. Nevro simply cannot show diligence in moving to amend.
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`For these reasons and those described below, the Court should deny Nevro’s motion.
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`II.
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`NATURE OF THE PROCEEDINGS
`
`BSC filed its Complaint on December 9, 2016, asserting infringement of ten patents
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`against Nevro and Nevro’s Senza® system; among them the ’280 Patent, the subject of this
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`motion. D.I. 1. BSC filed a First Amended Complaint (D.I. 13), and Nevro filed its answer on
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`February 27, 2017 (D.I. 18). Pursuant to the Scheduling Order, the deadline for the amendment
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`of pleadings was November 7, 2017. D.I. 27. Fact discovery closed on March 2, 2018. D.I.
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`186. Nevro previously filed two other Motions to Amend (D.I. 65 and D.I. 91), one of which
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`was filed after the deadline to amend, and both of which were denied. D.I. 73 and D.I. 126.
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`Nevro filed the present Motion for Leave to Amend its Answer on February 20, 2018. D.I. 193.
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`III.
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`SUMMARY OF THE ARGUMENT
`
`1.
`
`Nevro failed to establish (or even address) “good cause” for leave to amend under
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`Fed. R. Civ. P. 16(b). Nevro knew (or should have known) before the amendment deadline the
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`publicly available facts pleaded in its claims yet offers no adequate explanation as to why it did
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`not file the instant motion until more than three months after the November 7, 2017 deadline.
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`Nevro filed its third motion to amend only after the failure of two other motions to amend and its
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`IPRs; waiting to see if other litigation tactics work is not a legitimate reason for delay.
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`2.
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`Even if good cause did exist (which it does not), this Court should exercise its
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`discretion to deny Nevro’s motion under Fed. R. Civ. P. 15(a). Nevro’s counterclaims and
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`defenses are futile because Nevro pleads no facts showing BSC made any misrepresentation or
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`failed to disclose material information to raise an inference of intent to deceive. Nevro’s bad
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`faith assertion of inequitable conduct allegations prejudices BSC by reopening discovery and
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`subjecting BSC and its counsel to baseless allegations.
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`IV.
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`STATEMENT OF THE FACTS
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`A.
`
`The Pioneering Inventions Claimed in the ’280 Patent
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`In the late 1990’s, the SCS industry was in its infancy. Although many of the individual
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`components of present-day SCS systems existed at the time, they had never been successfully
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`integrated into a single SCS system. Engineers at Advanced Bionics (now BSC) were the first to
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`invent such a combination, filing a provisional application on July 27, 1999, for what became
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`Patent No. 6,516,227 (“’227 Patent”), the parent of the ’280 Patent.
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`Explaining the need for a new system, the common specification for the ’277 and ’280
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`Patents states that “not all of the [presently-known] features are available in one device” and
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`describes the prior SCS systems at that time as:
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`suffer[ing] from one or more shortcomings, e.g., [1] no internal power storage
`capability, [2] a short operating life, [3] none or limited programming features,
`[4] large physical size, [5] the need to always wear an external power source and
`controller, [6] the need to use difficult or unwieldy surgical techniques and/or
`tools, [7] unreliable connections, and the like.
`
`D.I. 1-1 at 2:7-8, 26-32 (emphasis added). The patent disclosed an SCS system “that is superior
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`to existing systems by providing longer life, easier programming and more stimulating features
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`in a smaller package without compromising reliability.” Id. at 2:32-36, 2:45-47. The
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`specification emphasized numerous features, including multichannel electrodes, small size, a
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`simple system for detaching leads, an implantable pulse generator (“IPG”) powered by a
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`rechargeable battery, non-invasive battery recharging, easy programming with more features—
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`all without compromising reliability. Id. at 2:45-4:7. The specification explains that “[a]ll of the
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`above and other features advantageously combine to provide an SCS system that is markedly
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`improved over what has heretofore been available.” Id. at 4:8-10 (emphasis added).
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`BSC’s novel SCS system embodying this combination—the first commercialized SCS
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`system to include a rechargeable battery3—was wildly successful. From 2004 to 2007, BSC
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`went from zero to one-third of the U.S. SCS market. Ex. B (excerpt of 2009 project overview
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`presentation). Others followed BSC’s lead. Within three years of BSC’s market entrance, 75%
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`of all U.S. SCS sales were of SCS systems with rechargeable batteries. Id.
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`B.
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`BSC Secured Patents By Claiming a Novel SCS System, Not By
`Contending that Rechargeable Batteries Were Unknown
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`Nevro’s Proposed Counterclaim asserts that the ’227 and ’280 Patents would not have
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`issued but for BSC deceiving the Examiner into believing that “the use of IPGs with
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`rechargeable batteries was ‘novel’” in the entirety of the art. D.I. 193-2, Ex. 2 ¶ 190. The
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`judicially-noticeable prosecution histories, however, show that BSC’s attorney, Bryant Gold,
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`explained that rechargeable batteries were missing from a single reference—U.S. Patent
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`No. 6,233,488 (“Hess”)—when overcoming an anticipation rejection, and that the Examiner
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`appreciated the significance of the references before him describing IPGs with such batteries.
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`When the Examiner cited Hess to disallow certain claims of the ’227 Patent as being
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`anticipated, he inaccurately stated that “[i]t would be obvious, if not inherent, for the IPG [in
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`Hess] to utilize a rechargeable internal battery.” D.I. 194-1, Ex. D at NEVRO_DE0289244.
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`Because the Examiner rejected the claims as anticipated, to overcome this rejection, Mr. Gold
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`needed only to show that Hess lacked a single limitation of the ’227 Patent.4 Mr. Gold did so by
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`accurately stating that Hess—not all prior art—failed to disclose a rechargeable battery and, in
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`fact, the only two commercial embodiments of Hess did not use a rechargeable battery. Id.
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`3 On April 28, 2004, Advanced Bionics (now BSC) issued a press release touting the FDA’s
`approval of “the first and only rechargeable implantable spinal cord stimulation (SCS) system
`for the treatment of chronic pain”; namely, BSC’s Precision® SCS system. Ex. C.
`4 Carman Indus., Inc. v. Wahl, 724 F.2d 932, 937 (Fed. Cir. 1983) (“Lacking an element of the
`claims, the reference cannot anticipate them under section 102.”).
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`at NEVRO_DE0289251 – 52. The Examiner agreed, finding the claims allowable over the prior
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`art system “described by Hess ’488.” Id. at NEVRO_DE0289264.
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`Nevro does not allege that Mr. Gold misled the Examiner about whether Hess disclosed a
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`rechargeable battery. Rather, taking Mr. Gold’s statement out of context, Nevro suggests that the
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`statement “one of the features of the system is the novel ability to recharge the battery contained
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`in the IPG” was intended to do far more than overcome the § 102 rejection. Nevro omits Mr.
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`Gold’s ultimate conclusion that, “as Hess does not show a rechargeable or replenishable internal
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`power source, Claims 2, 3, 19, and 20 are not anticipated by Hess ’488.” Id. at NEVRO_
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`DE0289253 (emphasis added). Nevro also omits Mr. Gold’s explanation that it was the “use of
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`such a rechargeable battery source that extends the life of the IPG” that was lacking in Hess.
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`Id. (emphasis added).
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`Contrary to Nevro’s allegation that Mr. Gold intended to deceive the Examiner about the
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`existence of IPGs with rechargeable batteries, Mr. Gold, consistent with BSC’s policy to disclose
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`all known material, non-cumulative art, disclosed at least eight such references.5 For example,
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`the ’624 Patent describes SCS systems that “may include a rechargeable or replenishable energy
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`source, e.g., a rechargeable battery or large capacitor.” See, e.g., Ex. E at 8:38-41. Indeed,
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`Nevro admits that “the Examiner found, by July 1999, ... IPGs that employ a replenishable
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`power source well-known.” D.I. 194, Ex. A. at 7 (emphasis added).
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`Nevro’s Proposed Counterclaims highlight U.S. Patent Nos. 5,560,693 (“Wang”),
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`5 These include U.S. Patent Nos.: 4,197,850 (Schulman); 4,459,989 (Borkan); 4,612,934
`(Borkan); 4,793,353 (Borkan); 5,735,887 (Barreras); 5,941,906 (Barreras); 6,016,449 (Fischell);
`6,052,624 (Mann) (“’624 Patent”). See Ex. D (excerpts of the ’227 prosecution history) at BSC-
`NVRO-DE_00209132-135. Additionally, the examiners themselves cited at least two references
`disclosing IPGs having rechargeable batteries, including U.S. Patent Nos.: 5,235,979 (Adams)
`and 6,185,452 (Schulman). Id. at BSC-NVRO-DE_00209144.
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`5,733,313 (“Barreras”), 6,067,474 (“Schulman ’474”), and 5,411,537 (“Munshi”), which Mr.
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`Gold disclosed in prosecution of Patent No. 6,553,263 (“the ’263 Patent”), but not in prosecuting
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`the ’280 or ’227 Patents. Nevro fails, however, to mention the ten rechargeable battery
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`references reviewed by the Examiner or to allege that its four references contain material
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`information not included in those ten references. Notably, the ’263 Patent is from a different
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`patent family, involves non-overlapping inventors, and claims very different inventions from the
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`’280 Patent. The ’263 Patent—entitled “Implantable pulse generators using rechargeable zero-
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`volt technology lithium-ion batteries”—is narrowly focused on IPGs and their batteries, not on
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`an entire SCS system, as claimed in the ’280 or ’227 Patents.
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`Unable to plead facts showing that these four references were non-cumulative, Nevro
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`falsely asserts that Mr. Gold “admitted having specific knowledge of key prior art references
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`disclosing IPGs with rechargeable batteries during prosecution of the ’280 and ’227 patents” that
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`he did not disclose. (D.I. 194 (“Op. Brf.”)) at 1-2. In fact, Mr. Gold testified that he would not
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`have necessarily remembered references he cited in prosecution of the ’263 patent when
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`prosecuting the ’227 or ’280 patents, given the large number of prosecutions for which he was
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`responsible. Ex. F at 166:8-16. He further testified that he would have disclosed all material,
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`non-cumulative prior art that he was aware of. Id. at 73:6-22, 175:12-19 (Mr. Gold: “I could
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`have known about it and didn’t cite it because it wasn’t relevant to those particular claims that
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`were being prosecuted and it could be … merely duplicative of what’s in the references cited.”).
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`Nevro implies Mr. Gold’s threat to walk out of the deposition was an admission that “Mr.
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`Gold effectively confirmed his responsibility for the misleading disclosures to the Patent Office.”
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`Op. Brf. at 9. In reality, Mr. Gold—who is in his 70’s, is retired, and has a heart condition—
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`became understandably frustrated after Nevro’s attorney repeatedly asked him to confirm what
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`the documents state6 and badgered him about what references were and were not cited during
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`prosecution—all of which was obvious on the face of the documents.7 Mr. Gold also expressed
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`offense at the suggestion that he committed inequitable conduct, explaining that he wouldn’t do
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`that; his practice was to stay focused on the claims in that case and disclose what was known in
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`that case (id. at 177:11-178:10)—a reasonable response based on Mr. Gold’s more than 35-year
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`career prosecuting patents, during which not one of his patents (to his knowledge) has ever been
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`held unenforceable. Id. at 10:22-25.
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`C.
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`BSC Prevailed in the IPR by Demonstrating that the Challenged
`Claims were Not Obvious Over the References Nevro Cited
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`Nevro alleges that BSC prevailed in the 1811 IPR by preventing Nevro from submitting
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`evidence that detachable leads and external trial stimulators (“ETSs”) preexisted in the art. Op.
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`Brf. at 13. In truth, Nevro submitted such evidence, BSC did not dispute it, and the Board did
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`not base its rejection of Nevro’s Petition on whether detachable leads or ETSs preexisted in the
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`art.
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`In its Petition, Nevro argued that Holsheimer, in view of other references, rendered the
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`challenged ’280 Patent claims obvious. D.I. 194, Ex. A at 8-9. Nevro contended that
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`Holsheimer (and not the other references) disclosed “an implantable electrode array detachably
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`connected to the IPG.” Id. at 26-27. Further, Nevro cited evidence stating that detachable leads
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`and ETSs were generally known in the art. Id. at 7-8.
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`In its Patent Owner’s Response, BSC emphasized that its patent claims an SCS system
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`6 See, e.g., Ex. F at 110:2-111:10, 113:4-12, 116:20-118:24, 120:7-121:4, 122:2-125:17, 126:11-
`129:25, 130:12-131:20, 133:2-10, 134:15-19, 135:4-136:13, 138:3-147:19, 148:4- 149:8, 151:13-
`152:3, 152:25-153:13, 154:5-16, 156:7-158:12.
`7 See, e.g., id. regarding Wang at 160:15-18, 163:7-9, 174:23-25, 175:4-22 ( “I’d object because
`it’s already been answered.... I mean, it seems to me we’re going in circles....”).
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`with “a novel combination of features.” D.I. 194, Ex. B at 1 (emphasis added). In responding
`
`to Nevro’s arguments regarding Holsheimer, BSC never contended that detachable leads were
`
`unknown in the art. Indeed, the ’280 Patent states that the “connector [that detachably secures
`
`the electrode array to the IPG] may be of the type described in U.S. patent application Ser. No.
`
`09/239,926, filed Jan. 28, 1999, now U.S. Pat. No. 6,198,969 or any other suitable design.” D.I.
`
`1-1 at 8:46-52 (emphasis added). Rather, BSC distinguished its claims from Holsheimer based
`
`on what was missing from that reference. Specifically, BSC showed that (1) neither Holsheimer
`
`nor the other 103 reference disclosed or suggested “an implantable electrode array detachably
`
`connected to the IPG,” and (2) a person of ordinary skill would not have been motivated to
`
`modify Holsheimer to include detachable leads. Id. at 22-29. Thus, “[a]lthough different types
`
`of leads may have been known in the art,” detachable leads would not have been used with
`
`Holsheimer’s system. Id. at 27.
`
`The Board acknowledged Nevro’s evidence “that ‘many different types of leads were
`
`known in the art and could be used with the same IPG’ and that ‘leads can be attached and
`
`detached to IPGs.’” D.I. 194, Ex. C at 12. The Board nevertheless denied the Petition because
`
`Nevro failed to show “this particular arrangement disclosed by Holsheimer is detachable.” Id.
`
`(emphasis added).8 Thus, the Board’s decision was not based on whether detachable leads
`
`preexisted in the art. Id. at 12-14.
`
`Nevro petitioned the Board for rehearing, based in part on its contention that the Board
`
`misapprehended or overlooked evidence that detachable leads were well-known. Ex. G at 3.
`
`
`8 Based on Nevro’s failure with respect to Holsheimer, the Board did not need to reach the
`question of whether another reference (Ruteki) taught the required ETS. D.I. 194, Ex. C at 14.
`Notably, however, BSC never disputed that ETSs were known in the art, contending instead that
`the ETS in the Ruteki reference is not suitable for a multi-day trial or use outside the operating
`room, as required by the challenged claims. D.I. 194, Ex. C at 32.
`
`
`01:22959293.1
`
`8
`
`

`

`Case 1:16-cv-01163-CFC-CJB Document 215 Filed 03/16/18 Page 13 of 27 PageID #: 6685
`
`
`
`The Board dismissed Nevro’s argument as immaterial:
`
`[O]ur Decision addresses Petitioner’s argument that detachable connections were
`well-known. As stated in the Decision, the cited evidence does not demonstrate
`persuasively that Holsheimer’s arrangement was detachable. The mere fact that
`a feature may have been well-known in the prior art is insufficient to establish
`that it was present in a specific prior art reference.
`
`Ex. A at 4-5 (citations omitted).
`
`At his deposition, Inventor Meadows was not asked whether the Holsheimer system
`
`disclosed detachable leads, whether the Ruteki ETS would have been a suitable ETS for the ’280
`
`system, or about any other issue in dispute in the IPR. Consequently, Mr. Meadows’ testimony
`
`that detachable leads and ETSs existed in the prior art is irrelevant, as is Nevro’s baseless and
`
`incorrect contention that BSC prevented Nevro from submitting this testimony to the Board.
`
`D.
`
`Nevro Misrepresents the Parties’ Meet and Confers Regarding the
`Confidentiality Designation of Mr. Meadows’ Transcript
`
`While Mr. Meadows’ testimony had no bearing on the IPR issues, BSC addresses
`
`Nevro’s baseless claims about its litigation conduct, to avoid any misimpression by the Court.
`
`Pursuant to Section 5.2(b) of the Stipulated Protective Order (“P.O.”) (D.I. 39), BSC
`
`designated the transcript as “Highly Confidential - Attorneys’ Eyes Only” on January 17, 2018.
`
`Ex. H. Nevro has likewise designated every transcript of every Nevro witness as “Highly
`
`Confidential” pursuant to the Sections 5.2 and 5.3 of the P.O. To date, Nevro has not provided
`
`particularized confidentiality designations for, or de-designated, any portion of any deposition.
`
`On January 25, 2018, the parties agreed that, instead of providing particularized
`
`confidentiality designations for each transcript, as set forth in Section 5.2(b) of the P.O., they
`
`would provide designations for portions of transcripts as needed on a case-by-case basis. Ex. I.
`
`Despite this agreement, Nevro requested that BSC de-designate the majority of Mr. Meadows’
`
`transcript, but did not request a response by any particular date or indicate that it believed any of
`
`
`01:22959293.1
`
`9
`
`

`

`Case 1:16-cv-01163-CFC-CJB Document 215 Filed 03/16/18 Page 14 of 27 PageID #: 6686
`
`
`
`the testimony was relevant to the issues in the IPR proceeding. Ex. J. BSC did not agree with
`
`Nevro’s overbroad proposed de-designations and therefore provided more particularized
`
`designations for the entire transcript on February 5, 2018, which was 21 days from receiving the
`
`final transcript and in compliance with the P.O. Ex. K.
`
`Nevro did not dispute BSC’s designations until February 16, 2018, eleven days after the
`
`Board denied Nevro’s IPR Petition. Ex. L at 102:2-25, 104:25-105:2. At that time, Nevro
`
`indicated that it was requesting the de-designation of just 17 lines of the transcript. Id. at 103:16-
`
`20. Within 15 minutes of the request, BSC agreed to de-designate those portions, taken out of
`
`their confidential context. Id. at 103:16-104:19. That same day, Nevro filed a Petition for
`
`Rehearing with the Board but did not even mention Mr. Meadows’ testimony. Ex. G.
`
`Contrary to Nevro’s argument that BSC “actively prevented Nevro from submitting Mr.
`
`Meadows’ testimony to the PTAB to alert the PTAB to the falsity of BSC’s submission” (Op.
`
`Brf. at 13), absent a request for BSC to expedite its response, Nevro could not have expected
`
`BSC’s confidentiality designations before the time period set forth in the P.O. or before the
`
`Board issued its institution decision. Nor did BSC have any reason to understand Nevro’s
`
`request regarding the Meadows transcript to bear any relation to the IPR proceedings since, as
`
`shown above, Mr. Meadows’ testimony was immaterial to the issues before the Board. See
`
`Section IV.D.; see Ex. L at 98:15-100:6, 101:3-11, 102:2-7.
`
`E.
`
`Nevro Failed to Take Discovery on a Potential Inequitable Conduct
`Claim Before the Deadline to Amend
`
`BSC filed this lawsuit on December 9, 2016. D.I. 1. The parties agreed to and the Court
`
`entered a deadline of November 7, 2017 to amend pleadings. D.I. 27. Nevro’s motion does not
`
`describe any actions that Nevro undertook to investigate its inequitable conduct allegations
`
`during this eleven-month period. Op. Brf. at 14-16.
`
`
`01:22959293.1
`
`10
`
`

`

`Case 1:16-cv-01163-CFC-CJB Document 215 Filed 03/16/18 Page 15 of 27 PageID #: 6687
`
`
`
`The inequitable conduct allegations against Mr. Gold and the inventors are based on
`
`publicly available documents: a comparison of the references disclosed for the ’263 Patent
`
`versus the ’227 and ’280 Patents, the prosecution histories of these patents, Mr. Gold’s listing as
`
`the responsible attorney, and the routine affidavits signed by the inventors. Indeed, Nevro’s
`
`allegations that references disclosed in the ’263 prosecution should have been disclosed in the
`
`’227 prosecution appear to be copied directly from those filed in Adv. Neuromod. Systems, Inc. v.
`
`Adv. Bionics Corp., E.D.T.X. No. 4:04cv131, Docket No. 284 (“ANS Litigation”), which have
`
`been publicly available on PACER since 2006. BSC produced a license agreement resulting
`
`from this litigation on September 18, 2017, well within the amendment period.
`
`Nevro contends that it

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