Boston Scientific Corp v. Nevro Corp

1. Case Identification

• Case #: IPR2020-01562
• Patent #: 9,002,460
• Filed: September 8, 2020
• Petitioner(s): Boston Scientific Corporation, and Boston Scientific Neuromodulation Corporation
• Patent Owner(s): Nevro Corporation
• Challenged Claims: 1-24

2. Patent Overview

• Title: Devices for Controlling Spinal Cord Modulation for Inhibiting Pain, and Associated Systems and Methods, Including Controllers for Automated Parameter Selection
• Brief Description: The ’460 patent relates to systems for controlling spinal cord stimulation (SCS) therapy. The invention centers on a programmer with a graphical user interface that displays images of a patient's vertebra and an implanted signal delivery device (lead), and allows a user to adjust the axial length of the vertebral image to better match the patient’s specific anatomy for programming stimulation parameters.

3. Grounds for Unpatentability

Ground 1: Obviousness over Bradley857 and Polefko - Claims 1-14 and 18-21 are obvious over Bradley857 in view of Polefko.

• Prior Art Relied Upon: Bradley857 (Application # 2012/0083857) and Polefko (Patent 9,358,390).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Bradley857 discloses all elements of the challenged claims except for the "Axial Length Limitation"—receiving a user input to change the axial length of the displayed vertebra image. Bradley857 teaches an SCS programming system that displays a generic spinal image where a user can superimpose lead images to establish their location. Polefko allegedly remedies this deficiency by teaching the use of a "scaling parameter," derived from patient information like height and weight, to adjust the dimensions of a vertebral image to make it "anatomically correct" relative to the lead images.
  • Motivation to Combine: A Person of Ordinary Skill in the Art (POSA) would combine Polefko's vertebral scaling with Bradley857's system to improve its accuracy and efficacy. The art recognized that creating an anatomically-correct model of lead placement improves the programmer's ability to determine effective stimulation parameters. Applying Polefko's specific technique for achieving this was a logical and predictable improvement to the system taught in Bradley857.
  • Expectation of Success: A POSA would have a reasonable expectation of success because Bradley857 and Polefko describe systems with substantially similar hardware and both model lead locations using a graphical spine. Implementing Polefko's scaling feature into Bradley857 would have been a routine matter of software programming.

Ground 2: Obviousness over Bradley857 and Davis - Claims 1-14 and 18-21 are obvious over Bradley857 in view of Davis.

• Prior Art Relied Upon: Bradley857 (Application # 2012/0083857) and Davis (Application # 2011/0093051).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground presented an alternative to Ground 1, with Davis providing the missing Axial Length Limitation. Petitioner asserted that Davis, like Polefko, teaches generating an anatomically-correct model for programming stimulation. Davis discloses a system where a user can drag-and-drop lead images onto an anatomical image and then separately "scale" or resize the vertebral image using on-screen tools to ensure the lead images reflect their correct locations relative to the patient's vertebrae.
  • Motivation to Combine: Similar to the motivation for combining with Polefko, a POSA would have been motivated to incorporate Davis's scaling technique into Bradley857 to improve the accuracy of the lead location model. Davis explicitly teaches that accurately defining a lead image relative to an anatomical target is helpful for programming, providing a clear reason to add this functionality to a system like Bradley857's.
  • Expectation of Success: The combination was argued to be predictable because both systems use similar hardware and drag-and-drop functionality. Davis provides explicit instructions for scaling vertebrae relative to leads, making the modification a routine software task with a high likelihood of success.

Ground 3: Obviousness over Bradley857, Polefko, and Alataris316 - Claims 15-17 and 22-24 are obvious over Bradley857 in view of Polefko and Alataris316.

• Prior Art Relied Upon: Bradley857 (Application # 2012/0083857), Polefko (Patent 9,358,390), and Alataris316 (Application # 2010/0274316).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground built upon the combination of Bradley857 and Polefko to address dependent claims reciting specific high-frequency stimulation ranges (e.g., 1.5 kHz to 100 kHz). Petitioner contended that while the base combination teaches the core programmable system, Alataris316 explicitly discloses the therapeutic use of high-frequency SCS within the exact frequency ranges recited in the claims to treat pain without producing paresthesia.
  • Motivation to Combine: A POSA would be motivated to program the Bradley857/Polefko system to operate at the high frequencies taught by Alataris316 to provide an alternative, effective therapy for patients who receive minimal benefit from traditional low-frequency SCS. Alataris316 identifies a specific patient population and provides a solution, motivating its application to other SCS systems.
  • Expectation of Success: Success was predictable as the systems use substantially the same hardware. The only change required would be programming the stimulation to operate at a different frequency, a known and straightforward adjustment.
• Additional Grounds: Petitioner asserted additional obviousness challenges based on combinations including Zhu (Application # 2011/0054551) for automatically updating stimulation parameters upon lead migration, and using Davis instead of Polefko in the high-frequency combination with Alataris316.

4. Arguments Regarding Discretionary Denial

• Petitioner argued that discretionary denial under §314(a) based on the Fintiv factors would be inappropriate. The petition asserted that the co-pending district court litigation was in its early stages, with minimal discovery conducted regarding the ’460 patent, and that a trial date was still over a year away and subject to potential delay. Petitioner also noted that the court had previously stayed related litigation pending IPR outcomes. Furthermore, the IPR challenges all 24 claims of the patent, whereas the district court case involves only a subset, meaning the IPR provides a more efficient and complete resolution. Petitioner stipulated that it would not pursue the same invalidity grounds in district court if the IPR was instituted.

5. Relief Requested

• Petitioner requests institution of an inter partes review and cancellation of claims 1-24 of the ’460 patent as unpatentable under 35 U.S.C. §103.