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

Patent Owner's Preliminary Response

Patent Owner's Exhibit List

Boston Scientific Corp. v. Nevro Corp., No. 18-644 (CFC), Dkt. 27, Answer, Affirmative Defenses, and Counterclaims to First Amended Complaint (D. Del. Dec. 9, 2019)

Boston Scientific Corp. v. Nevro Corp., No. 16-1163 (CFC) (Consolidated), Dkt. 551, Claim Construction Order (D. Del. Feb. 25, 2021)

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)

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)

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, Dkt. 1, Complaint (D. Del. Feb. 23, 2021)

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)

Boston Scientific Neuromodulation Corporation v. Nevro Corp., IPR2015-01203, 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., IPR2015-01204, 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 Corporation, IPR2015-01203, Paper 10, Decision Denying Institution of Inter Partes Review (PTAB Nov. 30, 2015)

Boston Scientific Neuromodulation Corporation v. Nevro Corp., IPR2015-01204, Paper 10, Decision Denying Institution of Inter Partes Review (PTAB Nov. 30, 2015)

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, 123 Anesthesiology 851-860 (2015)

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

Lee et al., Predicted Effects of Pulse Width Programming in Spinal Cord Stimulation: A Mathematical Modeling Study, 49 Medical & Biological Engineering & Computing 765-774 (2011)

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

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

Patent Owner's Mandatory Notices

Patent Owner's Power of Attorney

Notice: Notice filing date accorded

U.S. Patent No. 10,576,286 ("the '286 Patent")

File History of the '286 Patent (Part 1 of 4)

File History of the '286 Patent (Part 2 of 4)

File History of the '286 Patent (Part 3 of 4)

File History of the '286 Patent (Part 4)

February 15, 2022 Declaration of Marom Bikson, Ph.D.

Curriculum Vitae of Marom Bikson, Ph.D.

U.S. Patent No. 8,170,675 ("Alataris675")

U.S. Patent No. 9,002,459 ("Lee459")

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")

Shaw et al., 1200 Hz Sub-Threshold Epidural Stimulation for Pain Control ("Shaw")

"From Innovation to Reality," North American Neuromodulation Society, 16th Annual Meeting Syllabus, December 6-9, 2012

U.S. Patent No. 10,149,978 ("the '978 Patent")

File History of the '978 Patent (Part 1 of 8)

File History of the '978 Patent (Part 2 of 8)

File History of the '978 Patent (Part 3 of 8)

File History of the '978 Patent (Part 4 of 8)

File History of the '978 Patent (Part 5 of 8)

File History of the '978 Patent (Part 6 of 8)

File History of the '978 Patent (Part 7 of 8)

File History of the '978 Patent (Part 8 of 8)

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")

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) ("Wolter")

February 7, 2022 Declaration of Natalie Bryan

February 14, 2022 Declaration of Dr. Erik Shaw

Provisional Patent Application No. 61/901,255

U.S. Patent No. 8,892,209 ("the '209 Patent")

Abejon et al., Is Impedance a Parameter to be Taken into Account in Spinal Cord Stimulation?, Pain Physician 10:533-540 (2007)

February 15, 2022 Declaration of Michael Henry Verdolin, M.D.

Physician Implant Manual, Implantable Pulse Generator, Model SC1100 (Advanced Bionics 2003), available at https://www.fcc.gov/oet/ea/fccid (search Product Code ���SC-1100;��� then select ���Detail;��� then select ���Physician implant manual���)

Presentation 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

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

U.S. Publication No. 2012/0083857 ("Bradley")

U.S. Patent No. 6,516, 227 ("Meadows")

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

U.S. Patent No. 6,421,566 ("Holsheimer")

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

Falowski et al., Spinal Cord Stimulation: An Update, Neurotherapeutics, Vol. 5 86 (2008)

Congress of Neurological Surgeons 2006 Annual Meeting Preliminary Program

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")

Curriculum Vitae of Michael Henry Verdolin, M.D.

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

U.S. Publication No. 2012/0172946 ("Alataris946")

Curriculum Vitae of Dr. Erik Shaw

February 12, 2022 Declaration of Dr. Richard Boydston North

Curriculum Vitae of Dr. Richard Boydston North

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

News Release: Boston Scientific Announces Launch of New Precision Plus Spinal Cord Stimulation System

PMA P030017-S002, Boston Scientific Corp. Precision Spinal Cord Stimulation (SCS), Stimulator, Spinal-Cord, Totally Implanted for Pain Relief, Model No. SC-1110 (Oct. 1, 2004)

"From Innovation to Reality," North American Neuromodulation Society, 16th Annual Meeting Syllabus, December 6-9, 2012 (Ex. 2033 to Nevro Corporation's Preliminary Patent Owner Response in IPR2015-01203)

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

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

Medtronic Neurostimulation Systems Brochure (1999)

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)

De Jongste MJ, Hautvast RW, Hillege HL, et al. Efficacy of spinal cord stimulation as adjuvant therapy for intractable angina pectoris: a prospective, randomized clinical study. Working Group on Neurocardiology. 23 J Am Coll Cardiology 1592-97 (1994)

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)

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

Response for Certificate of Correction; U.S. Patent No. 9,002,459; dated January 25, 2022

Applicant's Reply to the Response to the Request for Certificate of Correction and Replacement Figure 6; U.S. Patent No. 9,002,459; dated July 28, 2021

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

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

U.S. Patent Publication No. 2008/0051839

U.S. Patent Publication No. 2004/0158298

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)

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

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

Petition for Inter Partes Review of US Patent 10,576,286

Power of Attorney