Boston Scientific Corporation et al. vs Nevro Corp.

Notice: refund approved

Petitioners Request for Refund of Post-Institution Fee

Settlement Prior to Institution of Trial

Joint Motion to Terminate

Highly Confidential Settlement Agreement

Joint Request That The Settlement Agreement Be Treated As Business Confidential Information

Exhibit 3001

Patent Owner's Sur-Reply

Petitioners' Reply to Patent Owner's Preliminary Response

U.S. Patent No. 9,724,513

U.S. Patent No. 10,463,861

Diedrichs, H., et al., Symptomatic Relief Precedes Improvement of Myocardial Blood Flow in Patients Under Spinal Cord Stimulation, Current Controlled Trials in Cardiovascular Medicine 6:7 (2005)

Wu, M. et al., Putative Mechanisms Behind Effects of Spinal Cord Stimulation on Vascular Diseases: A Review of Experimental Studies, 138 Autonomic Neurosci. 9-23 (2008)

Webster���s New World Medical Dictionary, 317-318, 420 (Wiley Publishing, Inc.) (3d ed.)

Petitioners' Updated Exhibit List

Patent Owner's Preliminary Response

Patent Owner Response to Petitioner Statement on Parallel Petitions

Patent Owner's Exhibit List

C.V. of Peter Crosby

Declaration of Peter Crosby

FDA Summary of Safety and Effectiveness Data, PMA P130022, Senza Spinal Cord Stimulation (SCS) System

Oakley, John, Spinal Cord Stimulation in Axial Low Back Pain: Solving the Dilemma, 7 Pain Medicine Number, S1 (2006)

Nevro Senza Spinal Cord Stimulator (SCS) System Patient Manual (2021)

C.V. of Michael Fishman, M.D.

Declaration of Michael Fishman, M.D.

Boston Scientific, Precision Spinal Cord Stimulator System Clinician Manual (2017)

St. Jude Medical, Eon Mini Rechargeable IPG

Medtronic, Medtronic Pain Therapy: Using neurostimulation for chronic pain, Information for prescribers (2017)

Perruchoud et al., Analgesic Efficacy of High-Frequency Spinal Cord Stimulation: A Randomized Double-Blind Placebo-Controlled Study, 16 Neuromodulation 363-369 (2013)

Linderoth et al., Chapter 25, Mechanisms of Spinal Cord Stimulation in Neuropathic and Ischemic Pain Syndromes, Neuromodulation 2009

Kumar et al., The Effects of Spinal Cord Stimulation in Neuropathic Pain Are Sustained: A 24-month Follow-up of the Prospective Randomized Controlled Multicenter Trial of the Effectiveness of Spinal Cord Stimulation, 63 Neurosurgery, 762-770 (2008)

Nevro Corp. v. Boston Scientific Corp., 955 F.3d 35 (Fed. Cir. 2020)

Nevro Corp. v. Boston Scientific Corp., No. 16-cv-06830-VC, 2018 WL 4676501 (N.D. Cal. July 24, 2018)

Van Buyten et al., High-Frequency Spinal Cord Stimulation for the Treatment of Chronic Back Pain Patients: Results of a Prospective Multicenter European Clinical Study, 16 Neuromodulation 59-66 (2013)

Al-Kaisy et al., Sustained Effectiveness of 10 kHz High-Frequency Spinal Cord Stimulation for Patients with Chronic, Low Back Pain: 24-Month Results of a Prospective Multicenter Study, 15 Pain Medicine 347-354 (2014)

Lempka et al., Computational Analysis of Kilohertz Frequency Spinal Cord Stimulation for Chronic Pain Management, 122 Anesthesiology 1362-76 (2015)

Tiede et al., Novel Spinal Cord Stimulation Parameters in Patients with Predominant Back Pain, 16 Neuromodulation 370-375 (2013)

Nevro Corp. v. Boston Scientific Corp., No. 3:16-cv-6830, Dkt. 1, Complaint for Patent Infringement and Declaratory Judgment, Demand for Jury Trial (N.D. Cal. Nov. 28, 2016)

Nevro Corp. v. Boston Scientific Corp., No. 3:16-cv-06830-VC, Dkt. 554, Stipulation and [Proposed] Order of Dismissal (N.D. Cal. Dec. 14, 2020)

Nevro Corp. v. Boston Scientific Corp., No. 1:21-cv-00258-UNA, Dkt. 1, Complaint (D.Del. Feb. 23, 2021)

Nevro Corp. v. Stimwave Technologies, Inc., No. 1:19-cv-00325-UNA, Dkt. 1, Complaint for Patent Infringement, Declaratory Judgment of Patent Infringement, Violation of the Lanham Act, and Deceptive Trade Practices (D. Del Feb. 14, 2019)

Nevro Corp. v. Stimwave Technologies, Inc., No. 1:19-cv-00325-CFC, Dkt. 98, Stimwave Answering Brief in Opposition to Plaintiff Nevro Motion for a Preliminary Injunction (D.Del. June 6, 2019)

Nevro Corp. v. Stimwave Technologies, Inc., No. 1:19-cv-00325-CFC, Dkt. 231, Stipulated Consent Judgment and Permanent Injunction (D.Del. Mar. 2, 2020)

Email from Jim Cassidy to Rafael Carbunaru, Jordi Parramon, Kerry Bradley, Ewan Gillespie, and Jesse Feinkind re: High frequency Nevro, dated Apr. 17, 2012

Switch to Nevro Study Final Report, Medtronic Loyalists Transition to Nevro, Prepared for: Boston Scientific Neuromodulation, dated Nov. 4, 2016

Email from Rafael Carbunaru to Maulik Nanavaty re: Kerry Bradley, dated May 1, 2012 (No. 3:16-cv-06830-VC, Dkt. 202-8, Exhibit B, Unredacted Version of Document Sought to be Sealed (Nov. 16, 2017)

Ex parte Knudson, Appeal No. 2021-001841, Decision on Appeal (PTAB Oct. 26, 2021)

Nevro Corp. v. Nalu Medical, Inc., No. 20-291 (CFC)(JLH), Nevro Corp. Response to Defendant Nalu Medical, Inc. First Set of Interrogatories (Nos. 1-10) (D.Del. May 7, 2021)

U.S. Patent No. 8,359,102 B2 to Alataris et al.

Boston Scientific Neuromodulation Corporation v. Nevro Corporation, IPR2015-01203, Paper 10, Decision Denying Institution of Inter Partes Review (PTAB Nov. 30, 2015)

Nevro, Neurosurgery Selects the SENZA-RCT 24-Month Outcomes Publication as the Top Pain Paper of the Year (June 15, 2017)

Kapural et al., Comparison of 10-kHz High-Frequency and Traditional Low-Frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain: 24-Month Results From a Multicenter, Randomized, Controlled Pivotal Trial

Nevro Corp. v. Nalu Medical, Inc., No. 1:20-cv-00291-CFC, Dkt. 14, First Amended Complaint for Patent Infringement (D. Del June 1, 2020)

Weinstein et al., Nevro, Let the Launch Begin: Senza Approved, Raising PT to $54, J.P. Morgan (May 10, 2015)

Lewis et al., Nevro Corp, Fundamentals are Very Much Intact, Morgan Stanley (Nov. 8, 2016)

Lewis et al., Disrupting Neuromodulation ��� Abbott & Nevro are the Winners, Morgan Stanley (Feb. 22, 2017)

Mills et al., Compelling growth engine with plenty of fuel in the tank; initiate at BUY, $120 target, Canaccord Genuity (Mar. 23, 2017)

WaveWriter Alpha Spinal Cord Stimulator System wins Best Overall Medical Device Solution Award (May 24, 2021)

Boston Scientific, Boston Scientific Launches WaveWriter Alpha Spinal Cord Stimulator Systems in U.S. (Jan. 14, 2021)

Nevro Corp. v. Stimwave Technologies, Inc., No. 19-325-CFC, 2019 WL 3322368 (D.Del. July 24, 2019)

Nevro Corp. v. Nalu Medical, Inc., No. 1:20-cv-00291-UNA, Dkt. 1, Complaint for Patent Infringement (D.Del. Feb. 28, 2020)

U.S. Patent and Trademark Office, Applicant-Initiated Interview Summary, Application No. 13/831,057 (Jan. 13, 2014)

Foletti et al., Neurostimulation technology for the treatment of chronic pain: a focus on spinal cord stimulation, Expert Rev. Med. Devices 4(2), 201-214 (2007)

EQ-5D-3L, About, available at https://euroqol.org/eq-5dinstruments/eq-5d-3l-about/

Kapural et al., Novel 10-kHz High-frequency Therapy (HF10 Therapy) Is Superior to Traditional Low-Frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain

Oakley et al., A New Spinal Cord Stimulation System Effectively Relieves Chronic, Intractable Pain: A Multicenter Prospective Clinical Study, 10 Neuromodulation 262-278 (2007)

U.S. Patent and Trademark Office, Declaration of James Thacker, Application No. 13/705/021 (Dec. 4, 2012) (No. 3:16-cv-06830-VC, Dkt. 398-13, Exhibit 12 (May 24, 2018))

Kloth, Luther, Electrical Stimulation Technologies for Wound Healing, Physical Therapy Faculty Research and Publications, Marquette University (Feb. 1, 2014)

Kathuroju et al., Effect of Low Frequency Pulsed DC on Human Skin in Vivo: Resistance Studies in Reverse Iontophoresis, 104 Sensors & Transducers Journal 47-57 (2009)

Nevro Corp. v. Boston Scientific Corp., No. 18-2220, Dkt. 32, Principal and Response Brief for Defendants-Cross-Appellants (Fed. Cir. Jan. 17, 2019)

Bendel, Markus, New Developments in Spinal Stimulation for Pain Management, Mayo Clinic (Nov. 20, 2018)

Perruchoud et al., Analgesic Efficacy of High-Frequency Cord Stimulation: A Randomized Double-Blind Placebo Controlled Study, 16 Neuromodulation 363-369 (2013)

Al-Kaisy et al., Prospective, Randomized, Sham-Control, Double Blind, Crossover Trial of Subthreshold Spinal Cord Stimulation at Various Kilohertz Frequencies in Subjects Suffering From Failed Back Surgery Syndrome (SCS Frequency Study)

Nalu Medical, Inc. v. Nevro Corporation, IPR2021-01023, Patent Owner Preliminary Response (PTAB Sep. 16, 2021)

Boston Scientific Neuromodulation Corporation v. Nevro Corporation, IPR2015-01203, Patent Owner Preliminary Response (PTAB Sep. 1, 2015)

Weinstein et al., Nevro, Welcome to the Future of Spinal Cord Stimulation; Initiating at OW with $34 Price Target, J.P. Morgan (Dec. 1, 2014)

Marcus et al., Nevro, Quarterly Results In-line with Preannouncement; Hiring in Focus for 2H18, J.P. Morgan (Aug. 2, 2018)

Boston Scientific Neuromodulation Corporation v. Nevro Corp., IPR2015-01023, Paper 1, Petition for Inter Partes Review of Claims 1, 2, 11-15, 17-23, 25 and 26 of U.S. Patent No. 8,359,102 (May 14, 2015)

Boston Scientific Neuromodulation Corporation v. Nevro Corp., IPR2015-01024, Paper 1, Petition for Inter Partes Review of Claims 1, 2, 11-15, 17-23, 25 and 26 of U.S. Patent No. 8,359,102 (May 14, 2015)

U.S. Patent No. 8,010,203 B2 to DeMulling et al.

Mironer et al., Pain Tolernace Threshold: A Pilot Study of an Objective Measurement of Spinal Cord Stimulator Trial Results, 1 Pain Medicine 110-115 (2000)

Smits et al., Spinal cord stimulation induces c-Fos expression in the dorsal horn in rats with neuropathic pain after partial sciatic nerve injury, 450 Neuroscience Letters 70-73 (2009)

Struijk et al., Paresthesia Thresholds in Spinal Cord Stimulation: A Comparison of Theoretical Results with Clinical Data, 1 IEEE Transactions on Rehabilitation Engineering 101-108 (1993)

Abejon et al., Effects of Movement and Postural Positions in Spinal Cord Stimulation in the New Rechargeable Systems, 17 Pain Physician 345-352 (2014)

Holsheimer et al., Spinal Geometry and Paresthesia Coverage in Spinal Cord Stimulation, 1 Neuromodulation 129-136 (1998)

Kumar et al., The use of spinal cord stimulation in pain management, 2 Pain Management 125-134 (2012)

Kumar, Krishna, Neuromodulation and Immortality, 17 Neuromodulation 401-403 (2014)

Taylor et al., Spinal cord stimulation in the treatment of refractory angina: systematic review and meta-analysis of randomised controlled trials, 9 BMC Cardiovascular Disorders (2009)

Nevro Senza Spinal Cord Stimulation (SCS) System Physician Implant Manual (2015)

Patent Owner's Mandatory Notices

Patent Owner's Power of Attorney

Notice: Notice filing date accorded

Petitioners' Updated Exhibit List

U.S. Patent No. 8,892,209

File History of U.S. Patent No. 8,892,209 (Part 1)

File History of U.S. Patent No. 8,892,209 (Part 2)

File History of U.S. Patent No. 8,892,209 (Part 3)

Eddicks et al., Thoracic Spinal Cord Stimulation Improves Functional Status and Relieves Symptoms in Patients with Refractory Angina Pectoris: The First Placebo-Controlled Randomized Study, 93 Heart 585 (2007) ("Eddicks")

U.S. Patent No. 7,177,690 ("Woods")

U.S. Patent No. 6,236,892 ("Feler892")

Yearwood and Foster, A Prospective Comparison of Spinal Cord Stimulation (SCS) Using Dorsal Column Stimulation (DCS), Intraspinal Nerve Root Stimulation (INRS), and Varying Pulse Width in the Treatment of Chronic Low Back Pain ("Yearwood")

February 7, 2022 Declaration of Marom Bikson, Ph.D.

Curriculum Vitae of Marom Bikson, Ph.D.

U.S. Provisional Appl. No. 61/171,790

U.S. Provisional Appl. No. 61/176,868

U.S. Patent Publication No. 2007/0073354 ("Knudson")

U.S. Patent No. 5,643,330 ("Holsheimer")

U.S. Patent Publication No. 2011/0184488 ("DeRidder1")

U.S. Patent Publication No. 2006/0004422 ("DeRidder2")

Falowski, et al, Spinal Cord Stimulation: An Update, Neurotherapeutics, The Journal of the American Society for Experimental NeuroTherapeutics. Vol. 5, 88-99, Jan. 2008

U.S. Patent Publication No. 2006/0015153 ("Gliner")

Physician Implant Manual, Implantable Pulse Generator, Model SC1100 (Advanced Bionics 2003)

Wolter et al., Effects of Sub-Perception Threshold Spinal Cord Stimulation in Neuropathic Pain: A Randomized Controlled Double-Blind Crossover Study, 16 European Journal of Pain, 648 (2012)

February 7, 2022 Declaration of Natalie Bryan

Poster for Yearwood and Foster, A Prospective Comparison of Spinal Cord Stimulation (SCS) Using Dorsal Column Stimulation (DCS), Intraspinal Nerve Root Stimulation (INRS), and Varying Pulse Width in the Treatment of Chronic Low Back Pain

U.S. Patent No. 8,774,912

Implant Manual, Model 3487A Pisces Quad, 3887 Pisces Quad Compact, 3888 Pisces Quad Plus (Medtronic 2014)

Summary of Safety and Effectiveness, PMA P030017, PRECISION��� Spinal Cord Stimulator (SCS) System (2004)

U.S. Patent Publication No. 2008/0051839

U.S. Patent Publication No. 2006/0167512

User Manual, Itrel�� EZ��� Model 7434A Patient Programmer (Medtronic 2001)

Implant Manual, Itrel 3 Model 7425 Neurostimulator (Medtronic 2003)

Summary of Safety and Effectiveness, PMA P960009/S7, Medtronic Activa�� Parkinson���s Control Therapy (2002)

PMA P840001-S037, Itrel 3 Spinal Cord Stimulation (SCS) for the Treatment of Chronic Intractable Pain of the Trunk and or Limbs (Aug. 29, 1995)

Technical Manual, Model 7427 Synergy, Model 7437V Synergy Versitrel (Medtronic 2003)

User Manual, Synergy EZ Model 7435 Patient Programmer (Medtronic 1998)

Curriculum Vitae of Michael Henry Verdolin, M.D.

U.S. Patent Publication No. 2004/0158298

Medtronic Neurostimulation Systems Brochure (1999)

Spinal Cord Stimulation, Patient Management Guidelines for Clinicians (Medtronic 1999), (Part 1)

Spinal Cord Stimulation, Patient Management Guidelines for Clinicians (Medtronic 1999), (Part 2)

Spinal Cord Stimulation, Patient Management Guidelines for Clinicians (Medtronic 1999), (Part 3)

Physician Lead Manual, Lead Model SC-2108 and Lead Extension Model SC-3108, Precision SCS System (Advanced Bionics 2004)

North et al., Spinal Cord Stimulation for Axial Low Back Pain, 30 Spine 1412-18 (2005)

Barolat et al., Mapping of Sensory Responses to Epidural Stimulation of Intraspinal Neural Structures in Man, 78 J. Neurosurgery 233-39 (1993)

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Aronow WS, Frishman WH, Spinal cord stimulation for the treatment of angina pectoris, 6 Curr. Treatment Options Cardiovascular Med. 79-83 (2004)

Mannheimer C, Eliasson T, Augustinsson LE, et al., Electrical stimulation versus coronary artery bypass surgery in severe angina pectoris: the ESBY Study. 97 Circulation 1157-63 (1998)

U.S. Patent No. 6,000,964 ("Feler964")

September 9, 2021 Deposition Transcript of Robert T. Stone in IPR2020-01562 and -01563

March 5, 2019, Second Preliminary Amendment in U.S. Patent Application No. 16/286,389, Declaration of James Watson, M.D., under 37 C.F.R. �� 1.132

Boston Scientific v. Nevro Corporation, Decision Denying Institution of Inter Partes Review, IPR2015-01204, Paper No. 10 (Nov. 30, 2015)

February 7, 2022 Declaration of Michael Henry Verdolin, M.D.

February 7, 2022 Declaration of Thomas L. Yearwood, M.D., Ph.D.

September 28, 2021, Oral Hearing in U.S. Application No. 16/286,389

U.S. Patent No. 5,776,170 ("MacDonald")

Kilgore and Bhadra, Nerve Conduction Block Utilising High-Frequency Alternating Current, 42 Med. & Bio. Eng. & Comp. 394 (2004) ("Kilgore")

Thomson et al., Effects of Rate on Analgesia in Kilohertz Frequency Spinal Cord Stimulation: Results of the PROCO Randomized Control Trial, 21 Neuromodulation 67-76 (2018)

PROCO RCT Optimal Signal Parameters provided by Wendy Gu, Ph.D.

PROCO RCT Pain Data provided by Wendy Gu, Ph.D.

Nalu Medical, Inc. v. Nevro Corporation, Patent Owner Preliminary Response, IPR2021-01023, Paper No. 11 (Sept. 16, 2021)

U.S. Patent No. 9,333,357

Curriculum Vitae of Thomas L. Yearwood, M.D., Ph.D.

Congress of Neurological Surgeons 2006 Annual Meeting Preliminary Program

U.S. Patent Publication No. 2007/0073354 of U.S. Application No. 16/286,389 ("Knudson389")

January 24, 2014, Amendment in U.S. Patent Application No. 12/765,747.

Bhadra N., et al., Simulation of high-frequency sinusoidal electrical block of mammalian myelinated axons, 22 J. Comput. Neurosci. 313-326 (2007) ("Bhadra (2007)")

Kilgore K.L. & Bhadra, N., Reversible Nerve Conduction Block Using Kilohertz Frequency Alternating Current, 17 Neuromodulation 242-255 (2014) ("Kilgore (2013)")

U.S. Patent No. 8,224,453

February 12, 2014, Notice of Allowance and Fees Due in U.S. Patent Application No. 12/765,747

U.S. Patent No. 6,892,097

Boston Scientific v. Nevro Corporation, Patent Owner's Contingent Motion to Amend, IPR2020-01562, Paper No. 25 (July 2, 2021)

Oakley, J.C., Spinal Cord Stimulation in Axial Low Back Pain: Solving the Dilemna, 7 Pain Medicine S1, S58-S63 (2006)

U.S. Patent No. 6,516,227

January 31, 2022 Declaration of Wendy Gu, Ph.D.

Merrill, D.R, et al., Electrical Stimulation of Excitable Tissue: Design of Efficactious and Safe Protocols 141 J. Neuroscience Methods 171-198 (2005)

Manuscript of Eddicks et al., Thoracic Spinal Cord Stimulation Improves Functional Status and Relieves Symptoms in Patients with Refractory Angina Pectoris: The First Placebo-Controlled Randomised Study, 93 Heart 585 (2007) ("Eddicks Manuscript")

Petition for Inter Partes Review

Boston Scientific Corporation and Boston Scientific Neuromodulation Corporation's Power of Attorney

Petitioners' Statement on Parallel Petitions