Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 1 of 78 PageID #: 367 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE

Transcription

1 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 1 of 78 PageID #: 367 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE Boston Scientific Corp. and Boston Scientific Neuromodulation Corp., Plaintiffs, v. C.A. No GMS Nevro Corp., JURY TRIAL DEMANDED Defendant. FIRST AMENDED COMPLAINT Plaintiffs Boston Scientific Corp. ( BSC ) and Boston Scientific Neuromodulation Corp. ( BSNC ) (collectively, Boston Scientific ), by their attorneys, hereby complain against Defendant Nevro Corp. ( Nevro ) and allege as follows: OVERVIEW OF THE ACTION 1. This is a patent infringement action arising from Nevro s infringement of Boston Scientific s U.S. Patent No. 6,895,280 (the 280 patent ), U.S. Patent No. 7,428,438 (the 438 patent ), U.S. Patent No. 7,437,193 (the 193 patent ), U.S. Patent No. 7,587,241 (the 241 patent ), U.S. Patent No. 7,891,085 (the 085 patent ), U.S. Patent No. 8,019,439 (the 439 patent ), U.S. Patent No. 8,644,933 (the 933 patent ), U.S. Patent No. 8,646,172 (the 172 patent ), U.S. Patent No. 8,650,747 (the 747 patent ), and U.S. Patent No. 9,370,664 (the 664 patent ) (collectively, the Asserted Patents ) via the manufacture, use, sale, offer to sell, exportation, and/or importation, in whole or in part, of Nevro s Senza Spinal Cord Stimulation System (the Senza System ). -1-

2 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 2 of 78 PageID #: 368 THE PARTIES 2. Plaintiff BSC is a corporation organized and existing under the laws of the State of Delaware and having a principal place of business at 300 Boston Scientific Way, Marlborough, Massachusetts Plaintiff BSNC is a corporation organized and existing under the laws of the State of Delaware and having a principal place of business at Rye Canyon Loop, Valencia, California BSNC is a wholly-owned subsidiary of BSC. 4. Upon information and belief, Defendant Nevro is a corporation organized and existing under the laws of the State of Delaware and having a principal place of business at 1800 Bridge Pkwy, Redwood City, California, JURISDICTION AND VENUE 5. This action arises under the Patent Laws of the United States, Title 35 of the United States Code. 6. This Court has subject matter jurisdiction over the causes of action asserted herein pursuant to 28 U.S.C. 1331, 1338(a), and 2201 et seq. 7. This Court has personal jurisdiction over Nevro. Upon information and belief, Nevro is a resident of this judicial district, has systematic and continuous contacts in this judicial district, regularly transacts business within this district, and regularly avails itself of the benefits of this district. Upon information and belief, Nevro also sells and distributes the Senza System in this district. Upon information and belief, Nevro derives substantial revenues from sales in this district. 8. Venue is proper in this District under 28 U.S.C. 1391(a), 1391(c), and 1400(b). -2-

3 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 3 of 78 PageID #: 369 BOSTON SCIENTIFIC S BACKGROUND 9. Boston Scientific is a leading medical device manufacturer across a range of medical specialties, including interventional cardiology, radiology, peripheral interventions, neuromodulation, neurovascular intervention, electrophysiology, cardiac surgery, vascular surgery, endoscopy, oncology, urology, and gynecology. Boston Scientific is a pioneer and innovator in the Spinal Cord Stimulation ( SCS ) industry, and has been developing and selling SCS systems for the treatment of chronic pain for over a decade. 10. Boston Scientific entered the SCS system market in 2004 when it launched its Precision SCS System, the first rechargeable SCS platform with unique current steering technology, wireless remote, and wireless charger. In 2007, Boston Scientific launched its improved Precision Plus SCS System, the first with EGL Scan technology, which displayed the relative position of the implanted leads to increase programming accuracy. In 2013, Boston Scientific launched the Precision Spectra SCS System, the world s first and only SCS platform with 32 contacts, to offer unprecedented coverage and a new level of flexibility intended to provide therapy to a broader spectrum of patients. The Precision Spectra SCS System included Illumina 3D Programming Technology, which provided advanced controls including the ability to account for the environment of the lead placed in the epidural space of the spine, with the design objective to optimize stimulation and pain relief. Boston Scientific next introduced the Precision Montage and Precision Montage MRI SCS System which allows patients to undergo a full-body MRI in Each of these systems and their technological advances provided drastic improvements in the care and treatment of patients with chronic pain. 11. Boston Scientific s position as a leader and innovator in the SCS industry has resulted in the development and patenting of core technologies that are essential to SCS systems, -3-

4 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 4 of 78 PageID #: 370 including battery charging, battery monitoring, zero volt recovery ( ZVR ) circuits, determining and transmitting indications of errors, telemetry systems, and percutaneous leads. These technologies form the foundation of every SCS system on the market, including Nevro s Senza System. NEVRO S INFRINGING SENZA SYSTEM 12. Nevro s Senza System is a neuromodulation device designed to deliver electrical stimulation to spinal cord nerves for the treatment of chronic intractable pain. The Senza System delivers stimulation using percutaneous leads and a rechargeable, implantable pulse generator ( IPG ). The percutaneous leads are implanted within the spinal column, and deliver stimulation to nerves through electrodes located on the distal portion of the percutaneous leads. The IPG is implanted in a subcutaneous pocket and is designed to produce current-regulated, chargebalanced, biphasic, capacitively-coupled, rectangular output pulses. The IPG is transcutaneously recharged using an external charger and is controlled by a patient remote control and/or clinician programmer. Other components of the Senza System include an external trial stimulator, lead extensions, adaptors, operating room ( OR ) cables, and surgical accessories. 13. The Senza System received CE Mark approval in Europe in 2010 and TGA approval in Australia in In that same year, Nevro launched the Senza System in Europe and Australia. In 2015, the Senza System received FDA approval and Nevro launched the product in the United States shortly thereafter. Currently, Nevro is on the market in Europe, Australia, and the United States Upon information and belief, C.C.C. Del Uruguay S.A. ( CCC ), a subsidiary of Greatbatch Ltd., is Nevro s single-source manufacturer of its IPG. Upon information and belief, 1 Source: -4-

5 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 5 of 78 PageID #: 371 CCC also manufactures Nevro s external chargers, external trial stimulators, and programmer wands. 2 Upon information and belief, CCC s manufacturing facility is located in Montevideo, Uruguay. 15. Upon information and belief, Stellar Technologies, Inc. ( Stellar, currently organized under the name Cirtec Medical LLC) is Nevro s single-source supplier of its percutaneous leads. 3 Stellar previously manufactured Boston Scientific s percutaneous leads. Upon information and belief, Stellar manufactures Nevro s leads with the same tool that it previously used to manufacture Boston Scientific s leads. Upon information and belief, Stellar s manufacturing facility is located in Brooklyn Park, Minnesota. 16. Upon information and belief, EaglePicher Medical Power LLC ( EaglePicher ) is Nevro s single-source supplier of its IPG s battery and related products. 4 Upon information and belief, EaglePicher is headquartered in Joplin, Missouri. 17. Upon information and belief, Pro-Tech Design and Manufacturing, Inc. ( Pro-Tech ) is Nevro s single-source supplier for conducting the inspection, labeling, packaging and sterilization of its Senza System. 5 Upon information and belief, Pro-Tech has two manufacturing facilities: one in Arlington, Texas and one in Santa Fe Springs, California. 6 Upon 2 Source: d102615d10k.htm. 3 Source: d102615d10k.htm. 4 Source: d102615d10k.htm. 5 Source: d102615d10k.htm. 6 Source: -5-

6 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 6 of 78 PageID #: 372 information and belief, Pro-Tech delivers the Senza System to Nevro FCA (Incoterms 2000) Pro- Tech s Santa Fe Springs, California manufacturing facility. 7 BOSTON SCIENTIFIC S PRE-SUIT INVESTIGATION 18. Boston Scientific engaged in an extensive pre-suit investigation to determine that Nevro s Senza System infringed the core SCS technologies claimed in the Asserted Patents. In addition to analyzing publicly available information regarding the Senza system, Boston Scientific acquired and examined Nevro IPGs, external chargers, remote controls, external trial stimulators, and percutaneous leads. As part of its examination, Boston Scientific disassembled Nevro s components to devise circuit schematics and part lists. Boston Scientific also performed chemical testing and extensive bench testing. Photographs and x-rays were taken throughout the process. Boston Scientific substantially completed its investigation by November NEVRO S KNOWLEDGE OF THE ASSERTED PATENTS 19. Upon information and belief, Nevro had actual and constructive knowledge of the Asserted Patents prior to the filing of the original Complaint or willfully blinded itself to the existence of those patents. In any event, Nevro had actual knowledge of the Asserted Patents no later than the filing of the original Complaint. 20. Upon information and belief, Nevro obtained actual and constructive knowledge of the Asserted Patents or willfully blinded itself to the existence of those patents through competitive intelligence of its direct competitor, Boston Scientific. The SCS market primarily consists of only four competitors: Boston Scientific, Nevro, Medtronic, and St. Jude. Nevro itself routinely identifies Boston Scientific as a direct competitor and the companies compete for 7 Source: a zex-10_3.htm. -6-

7 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 7 of 78 PageID #: 373 the same business from physicians, hospitals, and other health care providers. For instance, Nevro stated the following in its February 29, 2016 Form 10-K filing: Our competitors in both the United States and abroad, many of which have substantially greater resources and have made substantial investments in patent portfolios and competing technologies, may have applied for or obtained or may in the future apply for and obtain, patents that will prevent, limit, or otherwise interfere with our ability to make, use, sell, and/or export our products. For example, our major competitors, Medtronic plc, Boston Scientific Corporation and St. Jude Medical, Inc., each have significant patent portfolios covering systems, sub-systems, methods, and manufacturing processes. These competitors may have one or more patents for which they can threaten and/or initiate patent infringement actions against us and/or any of our third-party suppliers. 8 Moreover, Nevro participated in an FDA-monitored randomized controlled trial in a head-tohead comparison against Boston Scientific s Precision SCS System. As evidenced by Nevro s statement above, it is standard practice in the SCS industry to monitor competitors patent portfolios. Upon information and belief, Nevro monitored the patent portfolio of Boston Scientific, whereby Nevro obtained actual and constructive knowledge of the Asserted Patents. 21. Upon information and belief, Nevro obtained actual and constructive knowledge of the Asserted Patents or willfully blinded itself to the existence of those patents through a presuit investigation of Boston Scientific. In May 2015, Boston Scientific filed two Petitions for Inter Partes Review of Nevro s U.S. Patent No. 8,359,102. In November 2016, Nevro filed a Complaint for Patent Infringement and Declaratory Judgment against certain of Boston Scientific s SCS Systems in the United States District Court for the Northern District of California (Nevro Corp. v. Boston Scientific Corp. and Boston Scientific Neuromodulation Corp., 8 Source: d102615d10k.htm. -7-

8 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 8 of 78 PageID #: 374 Case No. 3:16-cv VC (N.D. Cal.)). It is standard practice to conduct competitive intelligence when sued and to conduct a pre-suit investigation prior to initiating a lawsuit. Upon information and belief, Nevro investigated Boston Scientific s patent portfolio no later than after Boston Scientific filed its Petitions for Inter Partes Review and before filing its Complaint in the Northern District of California, whereby Nevro obtained actual and constructive knowledge of the Asserted Patents. 22. Upon information and belief, Nevro obtained actual and constructive knowledge of the Asserted Patents or willfully blinded itself to the existence of those patents through the knowledge of current Nevro employees that previously worked for Boston Scientific, including employees that staffed critical Boston Scientific SCS product development and management positions responsible for its neuromodulation patent portfolio. For example, upon information and belief, Kerry Bradley is currently the Director of Clinical Science & Research at Nevro. Mr. Bradley worked for Boston Scientific (and its predecessors) from 2000 to 2012 as a Principal Biomedical Systems Engineer, Senior Principal Biomedical Systems Engineer, Fellow in Research & Development, and Manager II. During his time at Boston Scientific, Mr. Bradley was an inventor or co-inventor on numerous neuromodulation patents and was a subject matter expert reviewer of neuromodulation patents. 23. Upon information and belief, Jim Thacker is currently the Director of Field Clinical Engineering at Nevro. Mr. Thacker worked for Boston Scientific (and its predecessors) from 2000 to 2006 as Manager of Field Clinical Engineering. During his time at Boston Scientific, Mr. Thacker led Boston Scientific s field clinical engineering group, which helped to develop, administer, and analyze clinical studies, de-bugged SCS systems, and worked in conjunction with Boston Scientific s research & development group to develop, test, and -8-

9 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 9 of 78 PageID #: 375 commercialize its core SCS technologies. Mr. Thacker was an inventor or co-inventor on numerous neuromodulation patents. 24. Upon information and belief, Dongchul Lee is currently the Director of Theoretical Research at Nevro. Mr. Lee worked for Boston Scientific from 2006 to 2013 as a Senior Biomedical System Engineer and Principal Research Scientist. During his time at Boston Scientific, Mr. Lee developed numerous core SCS technologies, including stimulation algorithms and sub-perception stimulation. Mr. Lee was an inventor or co-inventor on numerous neuromodulation patents. 25. Upon information and belief, Messrs. Bradley, Thacker, and Lee had an extensive knowledge of Boston Scientific s neuromodulation patent portfolio, including many of the Asserted Patents, their applications, and/or their patent families. Upon information and belief, Nevro institutionalized this knowledge, whereby Nevro obtained actual and constructive knowledge of the Asserted Patents. 26. Upon information and belief, at least 48 past employees of Boston Scientific are currently employed by Nevro, including: Lisa Earnhardt, Member Board of Directors; Doug Alleavitch, Vice President, Quality; Reynaldo Nossa, Director of Technical Services; Andreas Koenig, Sr. Clinical Affairs Manager; David Marco, Sr. Field Clinical Engineer; Tamara Baynham, Sr. Field Clinical Engineer; Dan Hestera, Regional Sales Director; Jeff Orr, Regional Sales Director; Jim Sackleh, Regional Sales Director; Richard James, Regional Sales Director; Angela Holley, District Sales Manager; Laurie Cigan, District Sales Manager; Heather Moss- Gad, District Sales Manager; Anthony Puglisi, District Sales Manager; Cable Hawkins, District Sales Manager; Matt Goldstone, District Sales Manager; Phil Almeida, District Sales Manager; Ryan Livingston, District Sales Manager; Chris White, District Sales Manager; Lindsay Molden, -9-

10 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 10 of 78 PageID #: 376 District Sales Manager; Christine Biello, District Sales Manager; Chad Sellers, District Sales Manager; Brian Warriner, District Sales Manager; Scott Shoultz, District Sales Manager; Croix Paquin, District Sales Manager; Ashley Bailey, Therapy Consultant; Danielle Pronesti, Therapy Consultant; Mandy Cash, Therapy Consultant; Gretchen Thomas, Therapy Consultant; Will Windauer, Therapy Consultant; Kate Ginter, Therapy Optimization Specialist; and Kelly Engle, Therapy Support Specialist. (Source: linkedin.com.) Many of these Nevro employees are intimately familiar with Boston Scientific s SCS systems and core SCS technologies, which Boston Scientific has been developing for decades. Upon information and belief, Nevro strived to acquire information regarding Boston Scientific s SCS systems and core SCS technologies, and its institutional knowledge of the SCS market and SCS business practices. 27. Upon information and belief, Nevro obtained actual and constructive knowledge of the Asserted Patents or willfully blinded itself to the existence of those patents through the prosecution of its own patent portfolio. For example, the 280 patent is cited on the face of numerous U.S. Patents assigned to Nevro, including U.S. Patent No. 9,403,013; U.S. Patent No. 8,849,410; U.S. Patent No. 8,255,057; U.S. Patent No. 8,509,906; U.S. Patent No. 9,399,137; U.S. Patent No. 9,409,019; U.S. Patent No. 9,295,840; and U.S. Patent No. 9,517,344. Mr. Thacker, previously an employee of Boston Scientific, is a co-inventor on U.S. Patent No. 9,295,840. Mr. Bradley, previously an employee of Boston Scientific, is the only named inventor on U.S. Patent No. 9,517, The 193 patent is cited on the face of numerous U.S. Patents assigned to Nevro, including U.S. Patent No. 9,227,076; U.S. Patent No. 9,409,020; and U.S. Patent No. 9,517,344. Mr. Bradley, previously an employee of Boston Scientific, is the only named inventor on U.S. Patent No. 9,517,344. The 193 patent is the parent of the 241 patent. -10-

11 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 11 of 78 PageID #: The 439 patent is cited on the face of numerous U.S. Patents assigned to Nevro, including U.S. Patent No. 9,403,020; U.S. Patent No. 8,805,519; U.S. Patent No. 9,358,388; U.S. Patent No. 9,345,891; U.S. Patent No. 8,965,482; and U.S. Patent No. 9,308,022. Mr. Thacker, previously an employee of Boston Scientific, is a co-inventor on U.S. Patent No. 8,805,519; U.S. Patent No. 9,358,388; U.S. Patent No. 9,345,891; and U.S. Patent No. 8,965,482. The 439 patent is the child of the 085 patent. 30. Upon information and belief, Nevro was aware of the references cited on the face of Nevro patents, whereby Nevro obtained actual and constructive knowledge of the Asserted Patents. 31. To the extent that Nevro lacked actual and constructive knowledge of the Asserted Patents prior to the filing of the original Complaint, then Nevro willfully blinded itself to the existence of those patents. Upon information and belief, Nevro monitored and investigated Boston Scientific s patent portfolio, institutionalized the extensive knowledge of Boston Scientific s patent portfolio from past employees of Boston Scientific, and knew that certain of the Asserted Patents were cited on the face of Nevro patents. 32. Despite Nevro s actual and constructive knowledge of the Asserted Patents, it continues its infringing conduct to this day. COUNT I: INFRINGEMENT OF U.S. PATENT NO. 6,895, Boston Scientific realleges paragraphs 1-32 above as if fully set forth herein. 34. The 280 patent, entitled Rechargeable Spinal Cord Stimulator System, is a valid, enforceable patent that was duly issued by the United States Patent and Trademark Office ( USPTO ) on May 17, 2005 in full compliance with Title 35 of the United States Code. A true and correct copy of the 280 patent is attached as Exhibit A. -11-

12 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 12 of 78 PageID #: BSNC is the assignee of the 280 patent with ownership of all substantial rights in the 280 patent, including the right to exclude others and to enforce, sue, and recover damages for past and future infringements. BSC is the exclusive licensee of the 280 patent. 36. The claims of the 280 patent cover spinal cord stimulation systems. Claim 8 is illustrative of the claims of the 280 patent and is directed to a spinal cord stimulation system comprising a multi-channel IPG, which includes a replenishable power source, processing circuitry, and a housing that contains the processing circuitry. The IPG provides a multiplicity of stimulation channels, each of which is independently programmable with different stimulation parameters. The system includes an implantable electrode array detachably connected to the IPG and having a multiplicity of electrodes, wherein the number of stimulation channels is equal to or less than the number of electrodes. The system includes an external trial stimulator and a percutaneous extension which temporarily connects the external trial stimulator with the implantable electrode array. 37. Nevro has directly infringed, and continues to directly infringe, at least claim 8 of the 280 patent in violation of 35 U.S.C. 271(a) by, for example and without limitation, making, using, offering to sell, selling, and/or importing in and into the United States the Senza System. 38. The Senza System is a spinal cord stimulation system comprising a multi-channel IPG, implantable electrode array, and external trial stimulator. Boston Scientific, through its investigation of the Senza System via publicly available information and an examination of Nevro s IPG, has determined that the Senza System meets every element of at least claim 8 of the 280 patent, either literally or under the doctrine of equivalents: -12-

13 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 13 of 78 PageID #: 379 Claim Element A spinal cord stimulation system comprising: Senza System The Senza System is a spinal cord stimulation system, which delivers electrical stimulation to the spinal cord via percutaneous leads. a multi-channel implantable pulse generator (IPG) having a replenishable power source, the IPG having a housing which contains IPG processing circuitry; Source: The Senza System includes a multi-channel (see below) IPG having a rechargeable battery ( replenishable power source ) and a hermetic IPG titanium enclosure ( housing ), which contains circuitry for recharging the battery and providing stimulation pulses, among other processes. Source: Upon information and belief derived from Boston Scientific s investigation of the Senza System, the hermetic IPG titanium enclosure contains circuitry for recharging the battery and providing stimulation pulses, among other processes. an implantable electrode array detachably connected to the IPG, the electrode array having a multiplicity of n Source: The Senza System includes percutaneous leads ( implantable electrode arrays ) that are designed to connect to and disconnect from the IPG ( detachably connected ). -13-

14 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 14 of 78 PageID #: 380 electrodes (En) thereon; Source: The percutaneous leads include up to 16 electrodes ( multiplicity of n electrodes (En) thereon ). a multiplicity of m stimulation channels provided by the IPG, wherein each stimulation channel is independently programmable with different stimulation parameters, Source: System/default.aspx The IPG includes 16 output channels capable of stimulating the spinal cord nerves through electrode leads ( stimulation channels ), each of which can be independently programmed to deliver stimulation with different parameters, including amplitude, voltage, pulse width, and frequency, among other parameters. -14-

15 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 15 of 78 PageID #: 381 wherein m is equal to or less than n, and m is 2 or greater; Source: Source: an external trial stimulator (ETS); and The number of output channels (16) is equal to the number of electrodes (16). The Senza System includes an external trial stimulator. a percutaneous extension which temporarily couples the ETS Source: The Senza System includes OR cables ( percutaneous extension ) that make electrical and mechanical connections between the trial stimulator and the percutaneous leads. -15-

16 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 16 of 78 PageID #: 382 with the implantable electrode array. Source: Nevro has actively induced others to infringe at least claim 8 of the 280 patent in violation of 35 U.S.C. 271(b) by causing, instructing, urging, encouraging, and/or aiding others, including physicians, hospitals, other health care providers, and patients, to directly infringe at least claim 8 of the 280 patent by making, using, offering to sell, selling, and/or importing in and into the United States the Senza System, as detailed above. Nevro s active inducement includes, for example and without limitation, marketing, selling, and offering to sell the Senza System, providing instructions on how to use the Senza System, and promoting the use of the Senza System. For example, Nevro encourages physicians, hospitals, other health care providers, and patients to use the Senza System by means of marketing materials 9 and videos 10. Nevro also instructs physicians, hospitals, other health care providers, and patients on how to use 9 Exemplary marketing materials: Exemplary marketing videos:

17 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 17 of 78 PageID #: 383 the Senza System by means of physician and patient manuals 11. Upon information and belief, Nevro also has a clinical engineer, sales representative, therapy consultant, therapy optimization specialist, and/or therapy support specialist present in the operating room, as is customary in the SCS industry. These Nevro employees will provide guidance and instruction to the physicians during and after surgery, including by advising on lead placement, setting the stimulation parameters of the external trial stimulator or IPG, and otherwise programming the external trial stimulator or IPG and familiarizing the patient with the Senza System. Upon information and belief, Nevro knows or is willfully blind to the existence of the 280 patent, knows or is willfully blind to the fact that Nevro s actions will induce infringement thereof, and has induced such infringement with the intent that one or more claims of the 280 patent be infringed. 40. The foregoing actions by Nevro also constitute infringement of at least claim 8 of the 280 patent in violation of 35 U.S.C. 271(f)(1), wherein Nevro has supplied and/or caused to be supplied in or from the United States, and it continues to supply and/or cause to be supplied in or from the United States, the Senza System. Upon information and belief, Nevro has exported the Senza System from the United States to at least Europe and Australia. 41. Nevro has contributed to infringement by others of at least claim 8 of the 280 patent in violation of 35 U.S.C. 271(c) by offering to sell, selling, and/or importing the Senza System and/or one or more components of the Senza System to physicians, hospitals, and other health care providers, which, as detailed above, are components of a patented combination and which constitute a material part of the inventions claimed in the 280 patent, including without limitation the invention in at least claim 8 of the 280 patent. Nevro has offered to sell, 11 Physician Manual: Patient Manual:

18 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 18 of 78 PageID #: 384 sold, and/or imported the Senza System and/or one or more components of the Senza System knowing the same to be especially made or especially adapted for use in an infringement of at least claim 8 of the 280 patent, and that the Senza System and/or one or more components of the Senza System are not staple articles or commodities of commerce suitable for substantial noninfringing use. 42. For example, Nevro has offered to sell, sold, and/or imported its IPG and external trial stimulator (both of which, as detailed above, are components of a patented combination) to others, including physicians, hospitals, and other health care providers. The physicians, hospitals, and other health care providers then make, use, sell, or offer to sell systems that incorporate one or more of Nevro s components (e.g., incorporation of Nevro s IPG or external trial stimulator with other manufacturers leads 12 ) to directly infringe at least claim 8 of the 280 patent. Upon information and belief, Nevro, as detailed above, knows or is willfully blind to the existence of the 280 patent, knows or is willfully blind to the fact that Nevro s actions will contribute to the infringement thereof, and has contributed to such infringement with the intent that one or more claims of the 280 patent be infringed. Moreover, as detailed above, Nevro s IPG and external trial stimulator are a material part of the invention claimed in claim 8 of the 280 patent and, upon information and belief, Nevro knows that these components are especially made and/or especially adapted for use in infringing claim 8 of the 280 patent. Upon information and belief, these components are not staple articles or commodities of commerce suitable for substantial non-infringing use at least because Nevro s IPG and external trial stimulator have no use apart from, and are components of a medical device that is not approved for any purpose other than, making the infringing SCS system. 12 Source:

19 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 19 of 78 PageID #: The foregoing actions by Nevro also constitute infringement of at least claim 8 of the 280 patent in violation of 35 U.S.C. 271(f)(2), wherein Nevro has supplied and/or caused to be supplied in or from the United States, and it continues to supply and/or cause to be supplied in or from the United States, the Senza System. Upon information and belief, Nevro has exported the Senza System from the United States to at least Europe and Australia. 44. Upon information and belief, Nevro had actual and constructive knowledge of the 280 patent prior to the filing of the original Complaint. Nevro has continued to infringe at least claim 8 of the 280 patent. Nevro s infringement is reckless, knowing, deliberate, and willful. 45. Boston Scientific has been damaged as a result of Nevro s infringing conduct and is entitled to recover damages that adequately compensate it for Nevro s infringement, which, by law, cannot be less than a reasonable royalty, together with interest and costs as fixed by this Court under 35 U.S.C COUNT II: INFRINGEMENT OF U.S. PATENT NO. 7,428, Boston Scientific realleges paragraphs 1-45 above as if fully set forth herein. 47. The 438 patent, entitled Systems And Methods For Providing Power To A Battery In An Implantable Stimulator, is a valid, enforceable patent that was duly issued by the USPTO on September 23, 2008 in full compliance with Title 35 of the United States Code. A true and correct copy of the 438 patent is attached as Exhibit B. 48. BSNC is the assignee of the 438 patent with ownership of all substantial rights in the 438 patent, including the right to exclude others and to enforce, sue, and recover damages for past and future infringements. BSC is the exclusive licensee of the 438 patent. 49. The claims of the 438 patent cover implantable stimulators comprising ZVR circuits and devices, systems, and methods for providing power to implantable stimulators comprising ZVR circuits. Claim 1 is illustrative of the claims of the 438 patent and is directed -19-

20 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 20 of 78 PageID #: 386 to a system for providing power to a rechargeable battery in an implantable stimulator, wherein the system comprises a first coil that emits a first magnetic field and an implantable stimulator that includes a second coil that receives the first magnetic field and is tuned to the frequency of a second magnetic field, which provides power to the rechargeable battery (the ZVR circuit). 50. Nevro has directly infringed, and continues to directly infringe, at least claim 1 of the 438 patent in violation of 35 U.S.C. 271(a) by, for example and without limitation, making, using, offering to sell, selling, and/or importing in and into the United States the Senza System. 51. The Senza System is a system that provides power to a rechargeable battery in an implantable stimulator. Boston Scientific, through its investigation of the Senza System via publicly available information and an examination of Nevro s IPG, has determined that the Senza System meets every element of at least claim 1 of the 438 patent, either literally or under the doctrine of equivalents: Claim Element A system for providing power to a rechargeable battery in an implantable stimulator, said system comprising: Senza System The Senza System includes an external charger that recharges the Li-Ion battery located within the IPG. Source:

21 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 21 of 78 PageID #: 387 a first coil configured to emit a first magnetic field; Source: The Senza System includes a charger comprising a charging coil ( first coil ). Source: Source: Upon information and belief derived from Boston Scientific s investigation of the Senza System, the charger s charging coil emits -21-

22 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 22 of 78 PageID #: 388 electromagnetic fields as part of the Senza System s recharging scheme, which uses the charger s charging coil to transmit energy transcutaneously to recharge the IPG s Li-Ion battery. Source: a second coil in said stimulator configured to receive said first magnetic field; and Source: The Senza System includes a charging coil ( second coil ) in the IPG header. Source:

23 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 23 of 78 PageID #: 389 Source: NewsroomResources/1-1.jpg Upon information and belief derived from Boston Scientific s investigation of the Senza System, the IPG s charging coil receives electromagnetic fields as part of the Senza System s recharging scheme, which uses the IPG s charging coil to receive energy transcutaneously to recharge the IPG s Li-Ion battery. Source: a zero volt recovery (ZVR) circuit in said stimulator configured to use Source: Upon information and belief derived from Boston Scientific s investigation of the Senza System, the IPG includes a ZVR circuit that enables a portion of the IPG s charging coil (in the case of a depleted battery) to accept power from a very wide band of frequencies ( first -23-

24 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 24 of 78 PageID #: 390 said first magnetic field to cause said second coil in said stimulator to be tuned to a frequency of a second magnetic field, said second magnetic field used to provide said power to said battery. magnetic field ) and then, once the battery recovers to a certain threshold voltage, enables the processor and circuitry to tune the entire charging coil to a final frequency ( second magnetic field ) to charge the Li-Ion battery. 52. Nevro has actively induced others to infringe at least claim 1 of the 438 patent in violation of 35 U.S.C. 271(b) by causing, instructing, urging, encouraging, and/or aiding others, including physicians, hospitals, other health care providers, and patients, to directly infringe at least claim 1 of the 438 patent by making, using, offering to sell, selling, and/or importing in and into the United States the Senza System, as detailed above. Nevro s active inducement includes, for example and without limitation, marketing, selling, and offering to sell the Senza System, providing instructions on how to use the Senza System, and promoting the use of the Senza System. For example, Nevro encourages physicians, hospitals, other health care providers, and patients to use the Senza System by means of marketing materials 13 and videos Exemplary marketing materials: Exemplary marketing videos: Footnote continued on next page -24-

25 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 25 of 78 PageID #: 391 Nevro also instructs physicians, hospitals, other health care providers, and patients on how to use the Senza System by means of physician and patient manuals 15. Upon information and belief, Nevro also has a clinical engineer, sales representative, therapy consultant, therapy optimization specialist, and/or therapy support specialist present in the operating room, as is customary in the SCS industry. These Nevro employees will provide guidance and instruction to the physicians during and after surgery, including by advising on lead placement, setting the stimulation parameters of the external trial stimulator or IPG, and otherwise programming the external trial stimulator or IPG and familiarizing the patient with the Senza System. Upon information and belief, Nevro knows or is willfully blind to the existence of the 438 patent, knows or is willfully blind to the fact that Nevro s actions will induce infringement thereof, and has induced such infringement with the intent that one or more claims of the 438 patent be infringed. 53. The foregoing actions by Nevro also constitute infringement of at least claim 1 of the 438 patent in violation of 35 U.S.C. 271(f)(1), wherein Nevro has supplied and/or caused to be supplied in or from the United States, and it continues to supply and/or cause to be supplied in or from the United States, the Senza System. Upon information and belief, Nevro has exported the Senza System from the United States to at least Europe and Australia. Footnote continued from previous page Physician Manual: Patient Manual:

26 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 26 of 78 PageID #: Nevro has contributed to infringement by others of at least claim 1 of the 438 patent in violation of 35 U.S.C. 271(c) by offering to sell, selling, and/or importing the Senza System and/or one or more components of the Senza System to physicians, hospitals, and other health care providers, which, as detailed above, are components of a patented combination and which constitute a material part of the inventions claimed in the 438 patent, including without limitation the invention in at least claim 1 of the 438 patent. Nevro has offered to sell, sold, and/or imported the Senza System and/or one or more components of the Senza System knowing the same to be especially made or especially adapted for use in an infringement of at least claim 1 of the 438 patent, and that the Senza System and/or one or more components of the Senza System are not staple articles or commodities of commerce suitable for substantial noninfringing use. 55. For example, Nevro has offered to sell, sold, and/or imported its IPG and external charger (both of which, as detailed above, are components of a patented combination) to others, including physicians, hospitals, and other health care providers. The physicians, hospitals, and other health care providers then make, use, sell, or offer to sell systems that incorporate one or more of Nevro s components (e.g., incorporation of Nevro s IPG and external charger with other manufacturers leads 16 ) to directly infringe at least claim 1 of the 438 patent. Upon information and belief, Nevro, as detailed above, knows or is willfully blind to the existence of the 438 patent, knows or is willfully blind to the fact that Nevro s actions will contribute to the infringement thereof, and has contributed to such infringement with the intent that one or more claims of the 438 patent be infringed. Moreover, as detailed above, Nevro s IPG and external charger are a material part of the invention claimed in claim 1 of the 438 patent and, upon 16 Source:

27 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 27 of 78 PageID #: 393 information and belief, Nevro knows that these components are especially made and/or especially adapted for use in infringing claim 1 of the 438 patent. Upon information and belief, these components are not staple articles or commodities of commerce suitable for substantial non-infringing use at least because Nevro s IPG and external trial stimulator have no use apart from, and are components of a medical device that is not approved for any purpose other than, making the infringing system for providing power to a rechargeable battery in an implantable stimulator. 56. The foregoing actions by Nevro also constitute infringement of at least claim 1 of the 438 patent in violation of 35 U.S.C. 271(f)(2), wherein Nevro has supplied and/or caused to be supplied in or from the United States, and it continues to supply and/or cause to be supplied in or from the United States, the Senza System. Upon information and belief, Nevro has exported the Senza System from the United States to at least Europe and Australia. 57. Upon information and belief, Nevro had actual and constructive knowledge of the 438 patent prior to the filing of the original Complaint. Nevro has continued to infringe at least claim 1 of the 438 patent. Nevro s infringement is reckless, knowing, deliberate, and willful. 58. Boston Scientific has been damaged as a result of Nevro s infringing conduct and is entitled to recover damages that adequately compensate it for Nevro s infringement, which, by law, cannot be less than a reasonable royalty, together with interest and costs as fixed by this Court under 35 U.S.C COUNT III: INFRINGEMENT OF U.S. PATENT NO. 7,437, Boston Scientific realleges paragraphs 1-58 above as if fully set forth herein. 60. The 193 patent, entitled Microstimulator Employing Improved Recharging Reporting And Telemetry Techniques, is a valid, enforceable patent that was duly issued by the -27-

28 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 28 of 78 PageID #: 394 USPTO on October 14, 2008 in full compliance with Title 35 of the United States Code. A true and correct copy of the 193 patent is attached as Exhibit C. 61. BSNC is the assignee of the 193 patent with ownership of all substantial rights in the 193 patent, including the right to exclude others and to enforce, sue, and recover damages for past and future infringements. BSC is the exclusive licensee of the 193 patent. 62. The claims of the 193 patent cover implantable neural stimulator modules. Claim 1 is illustrative of the claims of the 193 patent and is directed to an implantable neural stimulator module comprising an hermetically-sealed housing containing an electronic subassembly and a rechargeable power source, and electrodes external to the hermetically-sealed housing. The electronic subassembly measures a voltage of the rechargeable power source when the power source is being recharged and when no stimulation is being provided, and wirelessly transmits the measured voltage to an external device. 63. Nevro has directly infringed, and continues to directly infringe, at least claim 1 of the 193 patent in violation of 35 U.S.C. 271(a) by, for example and without limitation, making, using, offering to sell, selling, and/or importing in and into the United States the Senza System. 64. The Senza System includes an implantable neural stimulator module. Boston Scientific, through its investigation of the Senza System via publicly available information and an examination of Nevro s IPG, has determined that the Senza System meets every element of at least claim 1 of the 193 patent, either literally or under the doctrine of equivalents: Claim Element An implantable neural stimulator module, comprising: Senza System The Senza System s IPG is an implantable neural stimulator module, which delivers electrical stimulation to the spinal cord via its percutaneous leads. -28-

29 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 29 of 78 PageID #: 395 an hermeticallysealed housing; Source: The IPG includes a hermetic IPG titanium enclosure ( hermetically-sealed housing ). an electronic subassembly housed within said hermetically-sealed housing; Source: Upon information and belief derived from Boston Scientific s investigation of the Senza System, the hermetic IPG titanium enclosure contains an electronic subassembly for recharging the battery and providing stimulation pulses, among other processes. a rechargeable power source contained within said hermeticallysealed housing and operatively connected to said electronic subassembly for providing operating power to said electronic subassembly; Source: The IPG includes a Li-Ion rechargeable battery ( rechargeable power source ) contained within the hermetic IPG titanium enclosure and connected to the electronic subassembly to provide power to the IPG. Source:

30 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 30 of 78 PageID #: 396 Source: a first electrode external to said hermetically-sealed housing and electrically coupled to said electronic subassembly; and Source: The IPG includes percutaneous leads, which include up to 16 electrodes ( first electrode ). Source: Source: System/default.aspx -30-

31 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 31 of 78 PageID #: 397 The percutaneous leads (including electrodes) are implanted near the patient s spine ( external to said hermetically-sealed housing ) and are connected to the IPG such that electrical energy can travel from the IPG and through the leads near the spine ( electrically coupled ). Source: a second electrode external to said hermetically-sealed housing and electrically coupled to said electronic subassembly, Source: The IPG includes percutaneous leads, which include up to 16 electrodes ( second electrode ). Source:

32 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 32 of 78 PageID #: 398 Source: System/default.aspx The percutaneous leads (including electrodes) are implanted near the patient s spine ( external to said hermetically-sealed housing ) and are connected to the IPG such that electrical energy can travel from the IPG and through the leads near the spine ( electrically coupled ). Source:

33 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 33 of 78 PageID #: 399 wherein the electronic subassembly measures a voltage of the rechargeable power source during recharging of the rechargeable power source via an external charging field, and wirelessly transmits the measured voltage to at least one external device, wherein the measured voltage is measured when no stimulation is being provided by the electronic subassembly. Source: Upon information and belief derived from Boston Scientific s investigation of the Senza System, the IPG s electronic subassembly measures the battery level ( measures a voltage ) of the IPG s Li-Ion rechargeable battery during transcutaneous recharging of the battery and transcutaneously transmits this measurement to the Senza System s external charger and remote control. The Li-Ion rechargeable battery s battery level is indicated on the battery level indicators found on the charger and remote control. Source: Source: Upon information and belief derived from Boston Scientific s -33-

34 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 34 of 78 PageID #: 400 investigation of the Senza System, the IPG s electronic subassembly measures the battery level when no stimulation is being provided by the electronic subassembly, e.g., when the patient turns off the stimulation. Source: Nevro has actively induced others to infringe at least claim 1 of the 193 patent in violation of 35 U.S.C. 271(b) by causing, instructing, urging, encouraging, and/or aiding others, including physicians, hospitals, other health care providers, and patients, to directly infringe at least claim 1 of the 193 patent by making, using, offering to sell, selling, and/or importing in and into the United States the Senza System, as detailed above. Nevro s active inducement includes, for example and without limitation, marketing, selling, and offering to sell the Senza System, providing instructions on how to use the Senza System, and promoting the use of the Senza System. For example, Nevro encourages physicians, hospitals, other health care providers, and patients to use the Senza System by means of marketing materials 17 and videos Exemplary marketing materials: Exemplary marketing videos: Footnote continued on next page -34-

35 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 35 of 78 PageID #: 401 Nevro also instructs physicians, hospitals, other health care providers, and patients on how to use the Senza System by means of physician and patient manuals 19. Upon information and belief, Nevro also has a clinical engineer, sales representative, therapy consultant, therapy optimization specialist, and/or therapy support specialist present in the operating room, as is customary in the SCS industry. These Nevro employees will provide guidance and instruction to the physicians during and after surgery, including by advising on lead placement, setting the stimulation parameters of the external trial stimulator or IPG, and otherwise programming the external trial stimulator or IPG and familiarizing the patient with the Senza System. Upon information and belief, Nevro knows or is willfully blind to the existence of the 193 patent, knows or is willfully blind to the fact that Nevro s actions will induce infringement thereof, and has induced such infringement with the intent that one or more claims of the 193 patent be infringed. 66. The foregoing actions by Nevro also constitute infringement of at least claim 1 of the 193 patent in violation of 35 U.S.C. 271(f)(1), wherein Nevro has supplied and/or caused to be supplied in or from the United States, and it continues to supply and/or cause to be supplied in or from the United States, the Senza System. Upon information and belief, Nevro has exported the Senza System from the United States to at least Europe and Australia. Footnote continued from previous page Physician Manual: Patient Manual:

36 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 36 of 78 PageID #: Nevro has contributed to infringement by others of at least claim 1 of the 193 patent in violation of 35 U.S.C. 271(c) by offering to sell, selling, and/or importing the Senza System and/or one or more components of the Senza System to physicians, hospitals, and other health care providers, which, as detailed above, are components of a patented combination and which constitute a material part of the inventions claimed in the 193 patent, including without limitation the invention in at least claim 1 of the 193 patent. Nevro has offered to sell, sold, and/or imported the Senza System and/or one or more components of the Senza System knowing the same to be especially made or especially adapted for use in an infringement of at least claim 1 of the 193 patent, and that the Senza System and/or one or more components of the Senza System are not staple articles or commodities of commerce suitable for substantial noninfringing use. 68. For example, Nevro has offered to sell, sold, and/or imported its IPG, external charger, and remote control (all of which, as detailed above, are components of a patented combination) to others, including physicians, hospitals, and other health care providers. The physicians, hospitals, and other health care providers then make, use, sell, or offer to sell systems that incorporate one or more of Nevro s components (e.g., incorporation of Nevro s IPG with other manufacturers leads 20 ) to directly infringe at least claim 1 of the 193 patent. Upon information and belief, Nevro, as detailed above, knows or is willfully blind to the existence of the 193 patent, knows or is willfully blind to the fact that Nevro s actions will contribute to the infringement thereof, and has contributed to such infringement with the intent that one or more claims of the 193 patent be infringed. Moreover, as detailed above, Nevro s IPG, external charger, and remote control are a material part of the invention claimed in claim 1 of the 20 Source:

37 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 37 of 78 PageID #: patent and, upon information and belief, Nevro knows that these components are especially made and/or especially adapted for use in infringing claim 1 of the 193 patent. Upon information and belief, these components are not staple articles or commodities of commerce suitable for substantial non-infringing use at least because Nevro s IPG, external charger, and remote control have no use apart from, and are components of a medical device that is not approved for any purpose other than, making the infringing implantable neural stimulator module. 69. The foregoing actions by Nevro also constitute infringement of at least claim 1 of the 193 patent in violation of 35 U.S.C. 271(f)(2), wherein Nevro has supplied and/or caused to be supplied in or from the United States, and it continues to supply and/or cause to be supplied in or from the United States, the Senza System. Upon information and belief, Nevro has exported the Senza System from the United States to at least Europe and Australia. 70. Upon information and belief, Nevro had actual and constructive knowledge of the 193 patent prior to the filing of the original Complaint. Nevro has continued to infringe at least claim 1 of the 193 patent. Nevro s infringement is reckless, knowing, deliberate, and willful. 71. Boston Scientific has been damaged as a result of Nevro s infringing conduct and is entitled to recover damages that adequately compensate it for Nevro s infringement, which, by law, cannot be less than a reasonable royalty, together with interest and costs as fixed by this Court under 35 U.S.C COUNT IV: INFRINGEMENT OF U.S. PATENT NO. 7,587, Boston Scientific realleges paragraphs 1-71 above as if fully set forth herein. 73. The 241 patent, entitled Method For Controlling Telemetry In An Implantable Medical Device Based On Power Source Capacity, is a valid, enforceable patent that was duly -37-

38 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 38 of 78 PageID #: 404 issued by the USPTO on September 8, 2009 in full compliance with Title 35 of the United States Code. A true and correct copy of the 241 patent is attached as Exhibit D. 74. BSNC is the assignee of the 241 patent with ownership of all substantial rights in the 241 patent, including the right to exclude others and to enforce, sue, and recover damages for past and future infringements. BSC is the exclusive licensee of the 241 patent. 75. The claims of the 241 patent cover methods for controlling an implantable medical device. Claim 1 is illustrative of the claims of the 241 patent and is directed to a method for controlling an implantable medical device comprising monitoring a voltage of a power source within the implantable medical device. If the voltage is above a first threshold, the implantable medical device listens for a first type of telemetry from a first external component, listens for a second type of telemetry from an external charging component, and provides stimulation to device electrodes. If the voltage falls below the first threshold, the implantable medical device discontinues listening for the first type of telemetry and discontinues providing stimulation, but continues to listen for the second type of telemetry from the external charging component. 76. Nevro has directly infringed, and continues to directly infringe, at least claim 1 of the 241 patent in violation of 35 U.S.C. 271(a) by, for example and without limitation, making, using, offering to sell, selling, and/or importing in and into the United States the Senza System. Nevro s use of the Senza System, alone or jointly with physicians, hospitals, other health care providers, and/or patients, practices each step of at least the method of claim 1 of the 241 patent. 77. The Senza System practices the method of controlling an implantable medical device. Boston Scientific, through its investigation of the Senza System via publicly available -38-

39 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 39 of 78 PageID #: 405 information and an examination of Nevro s IPG, has determined that the Senza System practices every step of at least claim 1 of the 241 patent, either literally or under the doctrine of equivalents, when used by Nevro, physicians, hospitals, other health care providers, and/or patients: Claim Element A method for controlling an implantable medical device, comprising: Senza System Use of the Senza System practices a method for controlling Nevro s IPG. monitoring a voltage of a power source within the implantable medical device; Source: The Senza System monitors the battery level of the IPG s Li-Ion rechargeable battery ( monitoring a voltage of a power source ). -39-

40 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 40 of 78 PageID #: 406 if the voltage is above a first threshold, enabling the following functions: listening for a first type of telemetry from a first external component; Source: Upon information and belief derived from Boston Scientific s investigation of the Senza System, the IPG s functionality is dependent upon its rechargeable battery s voltage. If the battery level is above a voltage threshold ( first threshold ), the IPG is fully operational. The Senza System includes telemetry schemes between the IPG and external components, e.g., Nevro s remote control communicates with the IPG via a radio-frequency telemetry scheme. Upon information and belief derived from Boston Scientific s investigation of the Senza System, this telemetry scheme is enabled when the IPG s battery is above a certain threshold. -40-

41 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 41 of 78 PageID #: 407 Source: listening for a second type of telemetry from an external charging component, wherein the external charging component is used to wirelessly charge the power source; and Source: The Senza System includes telemetry schemes between the IPG and the external charger, which is used to transcutaneously charge the IPG s Li- Ion rechargeable battery. Upon information and belief derived from Boston Scientific s investigation of the Senza System, this telemetry scheme is enabled when the IPG s battery is above a certain threshold. Source:

42 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 42 of 78 PageID #: 408 providing stimulation to device electrodes using the power source; and Source: The IPG stimulates the spinal cord nerves through electrode leads. Upon information and belief derived from Boston Scientific s investigation of the Senza System, the IPG s stimulation is enabled when the IPG s battery is above a certain threshold. if the voltage falls below the first threshold, discontinuing listening for the first type of telemetry from the first external component and discontinuing providing stimulation to device electrodes using the power source, while continuing listening for the second type of telemetry. Source: Upon information and belief derived from Boston Scientific s investigation of the Senza System, the IPG s functionality is dependent upon its rechargeable battery s voltage. If the battery level falls below a voltage threshold ( first threshold ), the IPG discontinues listening for the telemetry from the remote control and discontinues stimulation. If the battery level falls below the voltage threshold, the IPG continues to listen for the telemetry from the external charger. Source: Source:

43 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 43 of 78 PageID #: 409 Source: Nevro has actively induced others to infringe at least claim 1 of the 241 patent in violation of 35 U.S.C. 271(b) by causing, instructing, urging, encouraging, and/or aiding others, including physicians, hospitals, other health care providers, and patients, to directly infringe at least claim 1 of the 241 patent by using the Senza System, as detailed above. Nevro s active inducement includes, for example and without limitation, marketing, selling, and offering to sell the Senza System, providing instructions on how to use the Senza System, and promoting the use of the Senza System. For example, Nevro encourages physicians, hospitals, other health care providers, and patients to use the Senza System by means of marketing materials 21 and videos 22. Nevro also instructs physicians, hospitals, other health care providers, 21 Exemplary marketing materials: Exemplary marketing videos: Footnote continued on next page -43-

44 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 44 of 78 PageID #: 410 and patients on how to use the Senza System by means of physician and patient manuals 23. Upon information and belief, Nevro also has a clinical engineer, sales representative, therapy consultant, therapy optimization specialist, and/or therapy support specialist present in the operating room, as is customary in the SCS industry. These Nevro employees will provide guidance and instruction to the physicians during and after surgery, including by advising on lead placement, setting the stimulation parameters of the external trial stimulator or IPG, and otherwise programming the external trial stimulator or IPG and familiarizing the patient with the Senza System. Upon information and belief, Nevro knows or is willfully blind to the existence of the 241 patent, knows or is willfully blind to the fact that Nevro s actions will induce infringement thereof, and has induced such infringement with the intent that one or more claims of the 241 patent be infringed. 79. Nevro has contributed to infringement by others of at least claim 1 of the 241 patent in violation of 35 U.S.C. 271(c) by offering to sell, selling, and/or importing the Senza System and/or one or more components of the Senza System to physicians, hospitals, and other health care providers, which, as detailed above, are components of a patented combination and which constitute a material part of the inventions claimed in the 241 patent, including Footnote continued from previous page Physician Manual: Patient Manual:

45 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 45 of 78 PageID #: 411 without limitation the invention in at least claim 1 of the 241 patent. Nevro has offered to sell, sold, and/or imported the Senza System and/or one or more components of the Senza System knowing the same to be especially made or especially adapted for use in an infringement of at least claim 1 of the 241 patent, and that the Senza System and/or one or more components of the Senza System are not staple articles or commodities of commerce suitable for substantial noninfringing use. 80. For example, Nevro has offered to sell, sold, and/or imported its IPG, external charger, and remote control (all of which, as detailed above, are components of a patented combination) to others, including physicians, hospitals, and other health care providers. The physicians, hospitals, and other health care providers then use systems that incorporate one or more of Nevro s components (e.g., incorporation of Nevro s IPG, external charger, and remote control with other manufacturers leads 24 ) to directly infringe at least claim 1 of the 241 patent. Upon information and belief, Nevro, as detailed above, knows or is willfully blind to the existence of the 241 patent, knows or is willfully blind to the fact that Nevro s actions will contribute to the infringement thereof, and has contributed to such infringement with the intent that one or more claims of the 241 patent be infringed. Moreover, as detailed above, Nevro s IPG, external charger, and remote control are a material part of the invention claimed in claim 1 of the 241 patent and, upon information and belief, Nevro knows that these components are especially made and/or especially adapted for use in infringing claim 1 of the 241 patent. Upon information and belief, these components are not staple articles or commodities of commerce suitable for substantial non-infringing use at least because Nevro s IPG, external charger, and remote control have no use apart from, and are components of a medical device that is not 24 Source:

46 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 46 of 78 PageID #: 412 approved for any purpose other than, practicing the claimed method for controlling an implantable medical device. 81. Upon information and belief, Nevro had actual and constructive knowledge of the 241 patent prior to the filing of the original Complaint. Nevro has continued to infringe at least claim 1 of the 241 patent. Nevro s infringement is reckless, knowing, deliberate, and willful. 82. Boston Scientific has been damaged as a result of Nevro s infringing conduct and is entitled to recover damages that adequately compensate it for Nevro s infringement, which, by law, cannot be less than a reasonable royalty, together with interest and costs as fixed by this Court under 35 U.S.C COUNT V: INFRINGEMENT OF U.S. PATENT NO. 7,891, Boston Scientific realleges paragraphs 1-82 above as if fully set forth herein. 84. The 085 patent, entitled Electrode Array Assembly And Method Of Making Same, is a valid, enforceable patent that was duly issued by the USPTO on February 22, 2011 in full compliance with Title 35 of the United States Code. A true and correct copy of the 085 patent is attached as Exhibit E. 85. BSNC is the assignee of the 085 patent with ownership of all substantial rights in the 085 patent, including the right to exclude others and to enforce, sue, and recover damages for past and future infringements. BSC is the exclusive licensee of the 085 patent. 86. The claims of the 085 patent cover methods of manufacturing stimulation leads. Claim 1 is illustrative of the claims of the 085 patent and is directed to a method of manufacturing a stimulation lead having a proximal end and a distal end. A plurality of conductive contacts located at an end of a lead body of the stimulation lead are provided and a plurality of conductor wires are disposed in a plurality of conductor lumens formed in the lead -46-

47 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 47 of 78 PageID #: 413 body. At least one of the plurality of conductor wires is connected to each of the conductive contacts and spacers are placed between pairs of adjacent conductive contacts, wherein portions of the conductor lumens are located beneath the plurality of conductive contacts and the spacers. Monofilament is inserted 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 at least 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 the spacers and monofilament to a temperature to cause thermal flow or melting of at least one of the spacers or monofilament. 87. Nevro has directly infringed, and continues to directly infringe, at least claim 1 of the 085 patent in violation of 35 U.S.C. 271(a) by, for example and without limitation, making in the United States the Senza System s percutaneous leads. Nevro s manufacturing of the Senza System s percutaneous leads, alone or jointly with manufacturers, including Stellar, practices each step of at least the method of claim 1 of the 085 patent. 88. Manufacturing the Senza System s percutaneous leads practices the method of manufacturing a stimulation lead having a proximal end and a distal end. Boston Scientific, through its investigation of the Senza System via publicly available information and an examination of Nevro s percutaneous leads, has determined that manufacturing the Senza System s percutaneous leads practices every step of at least claim 1 of the 085 patent, either literally or under the doctrine of equivalents. The Senza System s percutaneous leads have a proximal end and a distal end and a plurality of electrodes located at an end of the lead body are provided. Upon information and belief, a plurality of electrode wires are disposed in a plurality of lumens formed in the lead body. Upon information and belief, at least one of the electrode wires is connected to each of the electrodes and spacers are placed between pairs of adjacent -47-

48 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 48 of 78 PageID #: 414 electrodes, wherein portions of the lumens are located beneath the electrodes and spacers. Upon information and belief, monofilament is inserted into at least one portion of at least one of the lumens in the lead body that is not occupied by the electrode wires and at least 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 the spacers and monofilament to a temperature to cause thermal flow or melting of at least one of the spacers or monofilament. 89. Nevro has actively induced others to infringe at least claim 1 of the 085 patent in violation of 35 U.S.C. 271(b) by causing, instructing, urging, encouraging, and/or aiding others, including Stellar, to directly infringe at least claim 1 of the 085 patent by making in the United States the Senza System s percutaneous leads, as detailed above. Nevro s active inducement includes, for example and without limitation, offering and contracting to purchase the Senza System s percutaneous leads 25, and providing instructions on how to make the Senza System s percutaneous leads. Upon information and belief, Nevro knows or is willfully blind to the existence of the 085 patent, knows or is willfully blind to the fact that Nevro s actions will induce infringement thereof, and has induced such infringement with the intent that one or more claims of the 085 patent be infringed. 90. Upon information and belief, Nevro had actual and constructive knowledge of the 085 patent prior to the filing of the original Complaint. Nevro has continued to infringe at least claim 1 of the 085 patent. Nevro s infringement is reckless, knowing, deliberate, and willful. 91. Boston Scientific has been damaged as a result of Nevro s infringing conduct and is entitled to recover damages that adequately compensate it for Nevro s infringement, which, by 25 Source: a zex-10_3.htm. -48-

49 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 49 of 78 PageID #: 415 law, cannot be less than a reasonable royalty, together with interest and costs as fixed by this Court under 35 U.S.C COUNT VI: INFRINGEMENT OF U.S. PATENT NO. 8,019, Boston Scientific realleges paragraphs 1-91 above as if fully set forth herein. 93. The 439 patent, entitled Lead Assembly And Method Of Making Same, is a valid, enforceable patent that was duly issued by the USPTO on September 13, 2011 in full compliance with Title 35 of the United States Code. A true and correct copy of the 439 patent is attached as Exhibit F. 94. BSNC is the assignee of the 439 patent with ownership of all substantial rights in the 439 patent, including the right to exclude others and to enforce, sue, and recover damages for past and future infringements. BSC is the exclusive licensee of the 439 patent. 95. The claims of the 439 patent cover stimulation leads and methods of making stimulation leads. Claim 1 is illustrative of the method claims of the 439 patent and is directed to a method of making a stimulation lead having a proximal end and a distal end. A plurality of conductive terminal contacts are placed at the proximal end of the stimulation lead and a plurality of electrode contacts are placed at the distal end of the stimulation lead. A plurality of conductor wires are connected to the plurality of terminal contacts such that for each of the plurality of terminal contacts a different conductor wire of the plurality of conductor wires connects to the terminal contact, wherein the plurality of conductor wires comprises a first conductor wire and a second conductor wire, wherein the first conductor wire extends within a first conductor lumen of a plurality of conductor lumens defined in a lead body of the stimulation lead, wherein the second conductor wire extends within a second conductor lumen of the plurality of conductor lumens defined in the lead body of the stimulation lead, wherein the lead -49-

50 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 50 of 78 PageID #: 416 body defines a stylet lumen configured and arranged for receiving a stylet, and wherein the plurality of conductor lumens and the stylet lumen each extend along a substantial length of the stimulation lead from the proximal end. A terminal spacer is placed between a pair of adjacent conductive terminal contacts of the plurality of conductive terminal contacts and an epoxy is applied to the proximal end of the stimulation lead such that the epoxy at least partially fills the conductor lumens in proximity to the proximal end of the stimulation lead. 96. Claim 11 is illustrative of the device claims of the 439 patent and is directed to a stimulation lead with proximal and distal ends and an insulative covering. The lead comprises a plurality of electrode contacts on the distal end of the stimulation lead and a plurality of conductive terminal contacts at the proximal end of the stimulation lead. The lead has a lead body extending along a substantial length of the stimulation lead, the lead body defining a plurality of conductor lumens and a stylet lumen. The plurality of conductor lumens and the stylet lumen extend along a length of the lead body and the plurality of conductor lumens comprises a first conductor lumen and a second conductor lumen. The lead has a plurality of conductor wires, each conductor wire of the plurality of conductor wires connecting a different one of the plurality of conductive terminal contacts to one of the electrode contacts. The plurality of conductor wires comprises a first conductor wire and a second conductor wire, wherein the first conductor wire extends along the first conductor lumen and the second conductor wire extends along the second conductor lumen. The lead also has a terminal spacer that is positioned between a first and a second adjacent terminal contacts of the plurality of conductive terminal contacts and epoxy that is within at least some portion of the plurality of conductor lumens in proximity to the proximal end of the stimulation lead. -50-

51 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 51 of 78 PageID #: Nevro has directly infringed, and continues to directly infringe, at least claim 1 of the 439 patent in violation of 35 U.S.C. 271(a) by, for example and without limitation, making in the United States the Senza System s percutaneous leads. Nevro s manufacturing of the Senza System s percutaneous leads, alone or jointly with manufacturers, including Stellar, practices each step of at least the method of claim 1 of the 439 patent. Nevro has directly infringed, and continues to directly infringe, at least claims 11 and 26 of the 439 patent in violation of 35 U.S.C. 271(a) by, for example and without limitation, making, using, offering to sell, selling, and/or importing in and into the United States the Senza System, including its percutaneous leads. 98. Manufacturing the Senza System s percutaneous leads practices the method of making a stimulation lead having a proximal end and a distal end. Boston Scientific, through its investigation of the Senza System via publicly available information and an examination of Nevro s percutaneous leads, has determined that manufacturing the Senza System s percutaneous leads practices every step of at least claim 1 of the 439 patent, either literally or under the doctrine of equivalents. The Senza System s percutaneous leads have a proximal end and a distal end. Upon information and belief, the Senza System s percutaneous leads are manufactured with a plurality of conductive terminals at the proximal end and a plurality of electrodes at the distal end. Upon information and belief, the Senza System s percutaneous leads are manufactured by connecting a plurality of conductor wires to the conductive terminals such that a different wire connects to each terminal. Upon information and belief, the lead body contains a stylet lumen and a plurality of conductor lumens, each extending along a substantial length of the stimulation lead from the proximal end. Upon information and belief, the Senza System s percutaneous leads contain a first and second conductor wire extending within a first -51-

52 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 52 of 78 PageID #: 418 and second conductor lumen, respectively. Upon information and belief, the Senza System s percutaneous leads contain a first and second conductor wire extending within a first and second conductor lumen, respectively. Upon information and belief, the Senza Systems leads have terminal spacers between pairs of adjacent conductive terminals and an epoxy applied to the proximal end of the lead, with the epoxy at least partially filling the conductor lumens near the proximal end of the lead. 99. The Senza System s percutaneous leads have proximal and distal ends and an insulative covering. Boston Scientific, through its investigation of the Senza System via publicly available information and an examination of Nevro s percutaneous leads, has determined that the Senza System s percutaneous leads meet every element of at least claims 11 and 26 of the 439 patent, either literally or under the doctrine of equivalents. An analysis of Nevro s infringement of claim 11, which is illustrative of the device claims of the 439 patent, follows. Upon information and belief, Nevro s leads have electrodes at the distal end and conductive terminals at the proximal end. Upon information and belief, the leads have a lead body that extends along a substantial length of the lead with conductor lumens and a stylet lumen extending along a length of the lead body. Upon information and belief, the leads also have a plurality of conductor wires connecting to the conductive terminals such that a different wire connects to each terminal. Upon information and belief, the Senza System leads contain a first and second conductor wire extending along a first and second conductor lumen, respectively. Upon information and belief, the Senza System leads have terminal spacers between pairs of adjacent conductive terminals and an epoxy within a portion of the conductor lumens near the proximal end of the lead. -52-

53 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 53 of 78 PageID #: Nevro has actively induced others to infringe at least claim 1 of the 439 patent in violation of 35 U.S.C. 271(b) by causing, instructing, urging, encouraging, and/or aiding others, including Stellar, to directly infringe at least claim 1 of the 439 patent by making in the United States the Senza System s percutaneous leads, as detailed above. Nevro s active inducement includes, for example and without limitation, offering and contracting to purchase the Senza System s percutaneous leads 26, and providing instructions on how to make the Senza System s percutaneous leads. Upon information and belief, Nevro knows or is willfully blind to the existence of the 439 patent, knows or is willfully blind to the fact that Nevro s actions will induce infringement thereof, and has induced such infringement with the intent that one or more claims of the 439 patent be infringed Nevro has actively induced others to infringe at least claims 11 and 26 of the 439 patent in violation of 35 U.S.C. 271(b) by causing, instructing, urging, encouraging, and/or aiding others, including physicians, hospitals, other health care providers, and patients, to directly infringe at least claims 11 and 26 of the 439 patent by making, using, offering to sell, selling, and/or importing in and into the United States the Senza System s percutaneous leads, as detailed above. Nevro s active inducement includes, for example and without limitation, marketing, selling, and offering to sell the Senza System s percutaneous leads, providing instructions on how to use the Senza System s percutaneous leads, and promoting the use of the Senza System s percutaneous leads. For example, Nevro encourages physicians, hospitals, other health care providers, and patients to use the Senza System, including its percutaneous leads, by 26 Source: a zex-10_3.htm. -53-

54 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 54 of 78 PageID #: 420 means of marketing materials 27 and videos 28. Nevro also instructs physicians, hospitals, other health care providers, and patients on how to use the Senza System, including its percutaneous leads, by means of physician and patient manuals 29. Upon information and belief, Nevro also has a clinical engineer, sales representative, therapy consultant, therapy optimization specialist, and/or therapy support specialist present in the operating room, as is customary in the SCS industry. These Nevro employees will provide guidance and instruction to the physicians during and after surgery, including by advising on lead placement, setting the stimulation parameters of the external trial stimulator or IPG, and otherwise programming the external trial stimulator or IPG and familiarizing the patient with the Senza System. Upon information and belief, Nevro knows or is willfully blind to the existence of the 439 patent, knows or is willfully blind to the 27 Exemplary marketing materials: Exemplary marketing videos: Physician Manual: Patient Manual:

55 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 55 of 78 PageID #: 421 fact that Nevro s actions will induce infringement thereof, and has induced such infringement with the intent that one or more claims of the 439 patent be infringed The foregoing actions by Nevro also constitute infringement of at least claims 11 and 26 of the 439 patent in violation of 35 U.S.C. 271(f)(1), wherein Nevro has supplied and/or caused to be supplied in or from the United States, and it continues to supply and/or cause to be supplied in or from the United States, the Senza System, including its percutaneous leads. Upon information and belief, Nevro has exported the Senza System from the United States to at least Europe and Australia Upon information and belief, Nevro had actual and constructive knowledge of the 439 patent prior to the filing of the original Complaint. Nevro has continued to infringe at least claims 1, 11, and 26 of the 439 patent. Nevro s infringement is reckless, knowing, deliberate, and willful Boston Scientific has been damaged as a result of Nevro s infringing conduct and is entitled to recover damages that adequately compensate it for Nevro s infringement, which, by law, cannot be less than a reasonable royalty, together with interest and costs as fixed by this Court under 35 U.S.C COUNT VII: INFRINGEMENT OF U.S. PATENT NO. 8,644, Boston Scientific realleges paragraphs above as if fully set forth herein The 933 patent, entitled Techniques For Controlling Charging Of Batteries In An External Charger And An Implantable Medical Device, is a valid, enforceable patent that was duly issued by the USPTO on February 4, 2014 in full compliance with Title 35 of the United States Code. A true and correct copy of the 933 patent is attached as Exhibit G. -55-

56 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 56 of 78 PageID #: BSNC is the assignee of the 933 patent with ownership of all substantial rights in the 933 patent, including the right to exclude others and to enforce, sue, and recover damages for past and future infringements. BSC is the exclusive licensee of the 933 patent The claims of the 933 patent cover external chargers for interfacing with implantable medical devices. Claim 1 is illustrative of the claims of the 933 patent and is directed to an external charger comprising a battery charging circuit for controlling the charging of the charger s battery, a transmitter for controlling a wireless transmission to an implantable medical device, wherein the wireless transmission provides power to charge the medical device s battery, and control circuitry for implementing an algorithm to controllably enable the battery charging circuit and the transmitter Nevro has directly infringed, and continues to directly infringe, at least claim 1 of the 933 patent in violation of 35 U.S.C. 271(a) by, for example and without limitation, making, using, offering to sell, selling, and/or importing in and into the United States the Senza System The Senza System includes an external charger for interfacing with Nevro s IPG. Boston Scientific, through its investigation of the Senza System via publicly available information and an examination of Nevro s IPG, has determined that the Senza System meets every element of at least claim 1 of the 933 patent, either literally or under the doctrine of equivalents: Claim Element An external charger for interfacing with an implantable medical device, comprising: Senza System The Senza System includes an external charger that recharges the IPG s rechargeable battery. Source:

57 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 57 of 78 PageID #: 423 a battery charging circuit for controlling the charging of an external battery in the external charger; Upon information and belief derived from Boston Scientific s investigation of the Senza System, the external charger includes battery charging circuitry that controls the charging of a rechargeable battery contained within the external charger. Source: a transmitter for controlling a wireless transmission to the implantable medical device, wherein the wireless transmission provides power to charge an implant battery in the implantable medical device; Source: Upon information and belief derived from Boston Scientific s investigation of the Senza System, the external charger includes a transmitter that controls electromagnetic fields ( wireless transmission ), which provide energy ( power ) to transcutaneously recharge the IPG s Li-Ion battery as part of the Senza System s recharging scheme. Source: Source: Source:

58 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 58 of 78 PageID #: 424 control circuitry for implementing an algorithm to controllably enable the battery charging circuit and the transmitter in the event that the control circuitry determines that both the external battery and the implant battery require charging. Upon information and belief derived from Boston Scientific s investigation of the Senza System, the external charger includes a control processor for implementing an algorithm that simultaneously charges the external charger s battery and the IPG s battery in the event that the control processor determines that both batteries require charging ( enable charging circuit and the transmitter ). For instance, as long as the external charger is connected to its power source, the control processor s algorithm enables simultaneous charging of both batteries even when the charger s battery level indicator shows less than two bars Nevro has actively induced others to infringe at least claim 1 of the 933 patent in violation of 35 U.S.C. 271(b) by causing, instructing, urging, encouraging, and/or aiding others, including physicians, hospitals, other health care providers, and patients, to directly infringe at least claim 1 of the 933 patent by making, using, offering to sell, selling, and/or importing in and into the United States the Senza System, as detailed above. Nevro s active inducement includes, for example and without limitation, marketing, selling, and offering to sell the Senza System, providing instructions on how to use the Senza System, and promoting the use of the Senza System. For example, Nevro encourages physicians, hospitals, other health care providers, and patients to use the Senza System by means of marketing materials 30 and videos Exemplary marketing materials: Exemplary marketing videos: Footnote continued on next page -58-

59 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 59 of 78 PageID #: 425 Nevro also instructs physicians, hospitals, other health care providers, and patients on how to use the Senza System by means of physician and patient manuals 32. Upon information and belief, Nevro also has a clinical engineer, sales representative, therapy consultant, therapy optimization specialist, and/or therapy support specialist present in the operating room, as is customary in the SCS industry. These Nevro employees will provide guidance and instruction to the physicians during and after surgery, including by advising on lead placement, setting the stimulation parameters of the external trial stimulator or IPG, and otherwise programming the external trial stimulator or IPG and familiarizing the patient with the Senza System. Upon information and belief, Nevro knows or is willfully blind to the existence of the 933 patent, knows or is willfully blind to the fact that Nevro s actions will induce infringement thereof, and has induced such infringement with the intent that one or more claims of the 933 patent be infringed The foregoing actions by Nevro also constitute infringement of at least claim 1 of the 933 patent in violation of 35 U.S.C. 271(f)(1), wherein Nevro has supplied and/or caused to be supplied in or from the United States, and it continues to supply and/or cause to be supplied in or from the United States, the Senza System. Upon information and belief, Nevro has exported the Senza System from the United States to at least Europe and Australia. Footnote continued from previous page Physician Manual: Patient Manual:

60 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 60 of 78 PageID #: Nevro has contributed to infringement by others of at least claim 1 of the 933 patent in violation of 35 U.S.C. 271(c) by offering to sell, selling, and/or importing the Senza System and/or one or more components of the Senza System to physicians, hospitals, and other health care providers, which, as detailed above, are components of a patented combination and which constitute a material part of the inventions claimed in the 933 patent, including without limitation the invention in at least claim 1 of the 933 patent. Nevro has offered to sell, sold, and/or imported the Senza System and/or one or more components of the Senza System knowing the same to be especially made or especially adapted for use in an infringement of at least claim 1 of the 933 patent, and that the Senza System and/or one or more components of the Senza System are not staple articles or commodities of commerce suitable for substantial noninfringing use For example, Nevro has offered to sell, sold, and/or imported its IPG and external charger (both of which, as detailed above, are components of a patented combination) to others, including physicians, hospitals, and other health care providers. The physicians, hospitals, and other health care providers then make, use, sell, or offer to sell systems that incorporate one or more of Nevro s components (e.g., incorporation of Nevro s IPG and external charger with other manufacturers leads 33 ) to directly infringe at least claim 1 of the 933 patent. Upon information and belief, Nevro, as detailed above, knows or is willfully blind to the existence of the 933 patent, knows or is willfully blind to the fact that Nevro s actions will contribute to the infringement thereof, and has contributed to such infringement with the intent that one or more claims of the 933 patent be infringed. Moreover, as detailed above, Nevro s IPG and external charger are a material part of the invention claimed in claim 1 of the 933 patent and, upon 33 Source:

61 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 61 of 78 PageID #: 427 information and belief, Nevro knows that these components are especially made and/or especially adapted for use in infringing claim 1 of the 933 patent. Upon information and belief, these components are not staple articles or commodities of commerce suitable for substantial non-infringing use at least because Nevro s IPG and external charger have no use apart from, and are components of a medical device that is not approved for any purpose other than, making the infringing external charger for interfacing with an implantable medical device The foregoing actions by Nevro also constitute infringement of at least claim 1 of the 933 patent in violation of 35 U.S.C. 271(f)(2), wherein Nevro has supplied and/or caused to be supplied in or from the United States, and it continues to supply and/or cause to be supplied in or from the United States, the Senza System. Upon information and belief, Nevro has exported the Senza System from the United States to at least Europe and Australia Upon information and belief, Nevro had actual and constructive knowledge of the 933 patent prior to the filing of the original Complaint. Nevro has continued to infringe at least claim 1 of the 933 patent. Nevro s infringement is reckless, knowing, deliberate, and willful Boston Scientific has been damaged as a result of Nevro s infringing conduct and is entitled to recover damages that adequately compensate it for Nevro s infringement, which, by law, cannot be less than a reasonable royalty, together with interest and costs as fixed by this Court under 35 U.S.C COUNT VIII: INFRINGEMENT OF U.S. PATENT NO. 8,646, Boston Scientific realleges paragraphs above as if fully set forth herein The 172 patent, entitled Electrode Array Assembly And Method Of Making Same, is a valid, enforceable patent that was duly issued by the USPTO on February 11, 2014 in -61-

62 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 62 of 78 PageID #: 428 full compliance with Title 35 of the United States Code. A true and correct copy of the 172 patent is attached as Exhibit H BSNC is the assignee of the 172 patent with ownership of all substantial rights in the 172 patent, including the right to exclude others and to enforce, sue, and recover damages for past and future infringements. BSC is the exclusive licensee of the 172 patent The claims of the 172 patent cover methods of manufacturing a stimulation lead. Claim 1 is illustrative of the claims of the 172 patent and is directed to a method of manufacturing a stimulation lead. A lead body is provided that comprises an insulation section defining a central lumen extending along the insulation section and a plurality of conductor lumens extending along the insulation section and arranged around, and external to, the central lumen. The lead body further comprises a plurality of conductive contacts located along an axial end of the lead body, and a plurality of conductor wires. Each of the conductor wires is disposed within one of the plurality of conductor lumens and each of the conductor lumens of the plurality of conductor lumens has at least one of the conductor wires of the plurality of conductor wires disposed therein. A portion of the conductor lumens is disposed radially beneath the conductive contacts. After providing the lead body, at least one of the plurality of conductor wires is conductively coupled to each of the conductive contacts and non-conductive material is placed into a portion of at least one of the conductor lumens of the lead body. At least a portion of the non-conductive material is disposed radially beneath the conductive contacts Nevro has directly infringed, and continues to directly infringe, at least claims 1 and 6 of the 172 patent in violation of 35 U.S.C. 271(a) by, for example and without limitation, making in the United States the Senza System s percutaneous leads. Nevro s -62-

63 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 63 of 78 PageID #: 429 manufacturing of the Senza System s percutaneous leads, alone or jointly with manufacturers, including Stellar, practices each step of at least the methods of claims 1 and 6 of the 172 patent Manufacturing the Senza System s percutaneous leads practices the method of manufacturing a stimulation lead. Boston Scientific, through its investigation of the Senza System via publicly available information and an examination of Nevro s percutaneous leads, has determined that manufacturing the Senza System s percutaneous leads practices every step of at least claims 1 and 6 of the 172 patent, either literally or under the doctrine of equivalents. An analysis of Nevro s infringement of claim 1, which is illustrative of the claims of the 172 patent, follows. Upon information and belief, the Senza System s percutaneous leads are manufactured by providing a lead body with an insulation section with a central lumen extending along the insulation section. Upon information and belief, a plurality of conductor lumens extend along the insulation section and are arranged around, and external to, the central lumen. Upon information and belief, the lead body also includes a plurality of conductive contacts along an axial end of the lead body and a plurality of conductor wires. Upon information and belief, each of the conductor wires is disposed within one of the conductor lumens and each of the conductor lumens has at least one of the conductor wires disposed therein. Upon information and belief, a portion of the conductor lumens is disposed radially beneath the conductive contacts. Upon information and belief, after providing the lead body, at least one of the conductor wires is conductively coupled to each of the conductive contacts and non-conductive material is placed into a portion of at least one of the conductor lumens of the lead body with at least a portion of the non-conductive material disposed radially beneath the conductive contacts Nevro has actively induced others to infringe at least claims 1 and 6 of the 172 patent in violation of 35 U.S.C. 271(b) by causing, instructing, urging, encouraging, -63-

64 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 64 of 78 PageID #: 430 and/or aiding others, including Stellar, to directly infringe at least claims 1 and 6 of the 172 patent by making in the United States the Senza System s percutaneous leads, as detailed above. Nevro s active inducement includes, for example and without limitation, offering and contracting to purchase the Senza System s percutaneous leads 34, and providing instructions on how to make the Senza System s percutaneous leads. Upon information and belief, Nevro knows or is willfully blind to the existence of the 172 patent, knows or is willfully blind to the fact that Nevro s actions will induce infringement thereof, and has induced such infringement with the intent that one or more claims of the 172 patent be infringed Upon information and belief, Nevro had actual and constructive knowledge of the 172 patent prior to the filing of the original Complaint. Nevro has continued to infringe at least claims 1 and 6 of the 172 patent. Nevro s infringement is reckless, knowing, deliberate, and willful Boston Scientific has been damaged as a result of Nevro s infringing conduct and is entitled to recover damages that adequately compensate it for Nevro s infringement, which, by law, cannot be less than a reasonable royalty, together with interest and costs as fixed by this Court under 35 U.S.C COUNT IX: INFRINGEMENT OF U.S. PATENT NO. 8,650, Boston Scientific realleges paragraphs above as if fully set forth herein The 747 patent, entitled Electrode Array Assembly And Method Of Making Same, is a valid, enforceable patent that was duly issued by the USPTO on February 18, 2014 in 34 a zex-10_3.htm. -64-

65 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 65 of 78 PageID #: 431 full compliance with Title 35 of the United States Code. A true and correct copy of the 747 patent is attached as Exhibit I BSNC is the assignee of the 747 patent with ownership of all substantial rights in the 747 patent, including the right to exclude others and to enforce, sue, and recover damages for past and future infringements. BSC is the exclusive licensee of the 747 patent The claims of the 747 patent cover a stimulation lead assembly for making a lead. Claim 1 is illustrative of the claims of the 747 patent and is directed to a stimulation lead assembly for making a lead, the assembly comprising a lead body, a plurality of electrically conductive contacts, a plurality of conductor wires, and a solid, non-conductive material. The lead body defines 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. The plurality of electrically conductive contacts are disposed along an end of the lead body, wherein a portion of each of the conductor lumens is disposed radially underneath the conductive contacts. The plurality of conductor wires are disposed in the conductor lumens, wherein at least one of the conductor wires is electrically connected to each conductive contact, 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. The solid, non-conductive material is disposed, at least in part, radially underneath the conductive contacts and fills the unoccupied portion of at least one of the conductor lumens, wherein the non-conductive material is thermally fused with the lead body from heat applied to the lead assembly, which heat is at a temperature to cause the nonconductive material to thermally reflow or melt. -65-

66 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 66 of 78 PageID #: Nevro has directly infringed, and continues to directly infringe, at least claims 1 and 11 of the 747 patent in violation of 35 U.S.C. 271(a) by, for example and without limitation, making, using, offering to sell, selling, and/or importing in and into the United States the Senza System, including its percutaneous leads The Senza System s percutaneous leads are a stimulation lead assembly. Boston Scientific, through its investigation of the Senza System via publicly available information and an examination of Nevro s percutaneous leads, has determined that the Senza System s percutaneous leads meet every element of at least claims 1 and 11 of the 747 patent, either literally or under the doctrine of equivalents. An analysis of Nevro s infringement of claim 1, which is illustrative of the claims of the 747 patent, follows. Upon information and belief, Nevro s lead assembly comprises a lead body, electrodes, conductor wires, and a solid, nonconductive material. Upon information and belief, the lead body defines 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. The electrodes are disposed along an end of the lead body and, upon information and belief, a portion of each of the conductor lumens is disposed radially underneath the electrodes. Upon information and belief, the conductor wires are disposed in the conductor lumens and at least one of the wires is electrically connected to each electrode. Upon information and belief, each conductor lumen comprises an occupied portion within which at least one of the conductor wires is disposed and an unoccupied portion extending from an end of the conductor lumen in which none of the conductor wires is disposed. Upon information and belief, the solid, non-conductive material is disposed, at least in part, radially underneath the electrodes and fills the unoccupied portion of at least one of the conductor lumens. Upon information and belief, the non-conductive material is thermally fused -66-

67 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 67 of 78 PageID #: 433 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 Nevro has actively induced others to infringe at least claims 1 and 11 of the 747 patent in violation of 35 U.S.C. 271(b) by causing, instructing, urging, encouraging, and/or aiding others, including physicians, hospitals, other health care providers, and patients, to directly infringe at least claims 1 and 11 of the 747 patent by making, using, offering to sell, selling, and/or importing in and into the United States the Senza System s percutaneous leads, as detailed above. Nevro s active inducement includes, for example and without limitation, marketing, selling, and offering to sell the Senza System s percutaneous leads, providing instructions on how to use the Senza System s percutaneous leads, and promoting the use of the Senza System s percutaneous leads. For example, Nevro encourages physicians, hospitals, other health care providers, and patients to use the Senza System, including its percutaneous leads, by means of marketing materials 35 and videos 36. Nevro also instructs physicians, hospitals, other 35 Exemplary marketing materials: Exemplary marketing videos: Footnote continued on next page -67-

68 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 68 of 78 PageID #: 434 health care providers, and patients on how to use the Senza System, including its percutaneous leads, by means of physician and patient manuals 37. Upon information and belief, Nevro also has a clinical engineer, sales representative, therapy consultant, therapy optimization specialist, and/or therapy support specialist present in the operating room, as is customary in the SCS industry. These Nevro employees will provide guidance and instruction to the physicians during and after surgery, including by advising on lead placement, setting the stimulation parameters of the external trial stimulator or IPG, and otherwise programming the external trial stimulator or IPG and familiarizing the patient with the Senza System. Upon information and belief, Nevro knows or is willfully blind to the existence of the 747 patent, knows or is willfully blind to the fact that Nevro s actions will induce infringement thereof, and has induced such infringement with the intent that one or more claims of the 747 patent be infringed The foregoing actions by Nevro also constitute infringement of at least claims 1 and 11 of the 747 patent in violation of 35 U.S.C. 271(f)(1), wherein Nevro has supplied and/or caused to be supplied in or from the United States, and it continues to supply and/or cause to be supplied in or from the United States, the Senza System, including its percutaneous leads. Upon information and belief, Nevro has exported the Senza System from the United States to at least Europe and Australia Upon information and belief, Nevro had actual and constructive knowledge of the 747 patent prior to the filing of the original Complaint. Nevro has continued to infringe at least Footnote continued from previous page Physician Manual: Patient Manual:

69 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 69 of 78 PageID #: 435 claims 1 and 11 of the 747 patent. Nevro s infringement is reckless, knowing, deliberate, and willful Boston Scientific has been damaged as a result of Nevro s infringing conduct and is entitled to recover damages that adequately compensate it for Nevro s infringement, which, by law, cannot be less than a reasonable royalty, together with interest and costs as fixed by this Court under 35 U.S.C COUNT X: INFRINGEMENT OF U.S. PATENT NO. 9,370, Boston Scientific realleges paragraphs above as if fully set forth herein The 664 patent, entitled Signaling Error Conditions In An Implantable Medical Device System Using Simple Charging Coil Telemetry, is a valid, enforceable patent that was duly issued by the USPTO on June 21, 2016 in full compliance with Title 35 of the United States Code. A true and correct copy of the 664 patent is attached as Exhibit J BSNC is the assignee of the 664 patent with ownership of all substantial rights in the 664 patent, including the right to exclude others and to enforce, sue, and recover damages for past and future infringements. BSC is the exclusive licensee of the 664 patent The claims of the 664 patent cover devices and systems that include error modulator circuitry. Claim 1 is illustrative of the claims of the 664 patent and is directed to an implantable medical device comprising a charging coil configured to receive power from an external charger and error modulator circuitry configured to determine a plurality of errors and transmit indications of the errors from the charging coil to the external charger. Each indication is transmitted at one of a plurality of frequencies, wherein each frequency indicates a particular one of the plurality of errors Nevro has directly infringed, and continues to directly infringe, at least claim 1 of the 664 patent in violation of 35 U.S.C. 271(a) by, for example and without limitation, -69-

70 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 70 of 78 PageID #: 436 making, using, offering to sell, selling, and/or importing in and into the United States the Senza System The Senza System includes Nevro s IPG, which includes error modulator circuitry. Boston Scientific, through its investigation of the Senza System via publicly available information and an examination of Nevro s IPG, has determined that the Senza System meets every element of at least claim 1 of the 664 patent, either literally or under the doctrine of equivalents: Claim Element An implantable medical device, comprising: Senza System The Senza System s IPG is an implantable medical device. a charging coil configured to receive power from an external charger; and Source: The IPG includes a charging coil in the IPG header. Source:

71 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 71 of 78 PageID #: 437 Source: NewsroomResources/1-1.jpg Upon information and belief derived from Boston Scientific s investigation of the Senza System, the IPG s charging coil receives electromagnetic fields as part of the Senza System s recharging scheme, which uses the IPG s charging coil to receive energy ( power ) transcutaneously to recharge the IPG s Li-Ion battery. Source: error modulator circuitry configured to determine a plurality of errors Source: Upon information and belief derived from Boston Scientific s investigation of the Senza System, the IPG includes error modulator circuitry that is configured to determine a plurality of errors in the IPG, including loss of charging connection, degradation of charging -71-

72 Case 1:16-cv GMS Document 13 Filed 02/13/17 Page 72 of 78 PageID #: 438 present in the implantable medical device, and configured to transmit indications of the determined errors from the charging coil to the external charger, connection, low battery, and system failure, among other errors. As explained in more detail below, indications of these errors are transmitted from the charging coil to the external charger. Source: wherein each indication is transmitted at one of a plurality of frequencies, wherein each frequency indicates a particular one of the plurality of errors. Source: Upon information and belief derived from Boston Scientific s investigation of the Senza System, the IPG utilizes at least two communications protocols to transmit indications of errors to the external charger. Under normal operating conditions, the IPG communicates via its microcontroller through an embedded radio-frequency transceiver. However, when the IPG s radio-frequency protocol suffers an error that prohibits radio-frequency communication, the IPG communicates fixed error codes via the charging coil ( transmit indications of the determined errors from the charging coil ). Each error code corresponds to a particular frequency, which is set by enabling/disabling individual coil elements. The external charger determines the error code by sensing a change in the coil coupling impedance Nevro has actively induced others to infringe at least claim 1 of the 664 patent in violation of 35 U.S.C. 271(b) by causing, instructing, urging, encouraging, and/or aiding others, including physicians, hospitals, other health care providers, and patients, to directly infringe at least claim 1 of the 664 patent by making, using, offering to sell, selling, and/or importing in and into the United States the Senza System, as detailed above. Nevro s active inducement includes, for example and without limitation, marketing, selling, and offering to sell -72-