Boston Scientific Corp v. Nevro Corp

1. Case Identification

• Case #: IPR2020-01563
• Patent #: 10,076,665
• Filed: September 8, 2020
• Petitioner(s): Boston Scientific Corporation, Boston Scientific Neuromodulation Corporation
• Patent Owner(s): Nevro Corporation
• Challenged Claims: 1-21

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 ’665 patent discloses systems for controlling spinal cord stimulation (SCS) to inhibit pain. The technology involves a patient treatment system with implanted signal delivery leads that have multiple contacts (electrodes) and a controller that automatically selects therapy parameters based on the established positions of the leads relative to a patient’s anatomy.

3. Grounds for Unpatentability

Ground 1: Anticipation - Claims 1-21 are anticipated by Bradley857 under 35 U.S.C. §102.

• Prior Art Relied Upon: Bradley857 (Application # 2012/0083857), which Petitioner argued incorporates by reference the entire disclosures of Bradley384 (Patent 6,993,384) and Meadows (Patent 6,516,227).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Bradley857, when read to include the full disclosures of the expressly incorporated references, teaches every limitation of the challenged claims. Bradley857 itself was asserted to disclose the overall patient treatment system, including a clinician programmer that receives inputs establishing the positional relationship of implanted leads relative to a patient’s anatomy (e.g., vertebrae). Petitioner contended that the incorporated Bradley384 reference provides the critical limitation of using measured impedance values to "align a computer-based image of the second signal delivery device relative to a computer-based image of the first." Further, the incorporated Meadows reference allegedly discloses identifying contacts for therapy that "have impedance values within a pre-established range," a method for ensuring electrode functionality. Together, Petitioner argued this single, combined reference disclosed automatically identifying signal delivery parameters based on a predetermined correlation between the established lead positions and a database of patient information.
  • Key Aspects: The core of this ground rested on the legal argument that Bradley857’s use of language such as "are expressly incorporated herein by reference" is sufficient to treat the three documents as a single prior art reference for the purpose of anticipation.

Ground 2: Obviousness - Claims 1-21 are obvious over Bradley857 in view of Bradley384 and Meadows under 35 U.S.C. §103.

• Prior Art Relied Upon: Bradley857 (Application # 2012/0083857), Bradley384 (Patent 6,993,384), and Meadows (Patent 6,516,227).
• Core Argument for this Ground:
  • Prior Art Mapping: As an alternative to anticipation, Petitioner argued the claims are obvious over the combination of the three references. Bradley857 provided the primary framework: an SCS system that uses a graphical user interface to establish lead positions relative to the spine and uses a patient database to automatically generate stimulation parameters. Petitioner asserted that Bradley384 taught using interelectrode impedance measurements to determine the relative orientation of implanted leads and to create a corresponding graphic display, a technique directly applicable to the alignment step in the claims. Meadows taught the well-known practice of measuring monopolar impedance for each electrode to confirm its functionality and availability for programming, satisfying the limitation that contacts must have impedance values within a pre-established range.
  • Motivation to Combine: Petitioner argued a person of ordinary skill in the art (POSITA) would combine these references because Bradley857 identified known problems in SCS and expressly pointed to the solutions taught in the other references. Bradley857 noted the need for correct lead placement and suggested using "measured electrical parameters" to define lead orientation, explicitly referencing and incorporating Bradley384 for this purpose. Similarly, Bradley857’s system relied on a functional implantable pulse generator (IPG), and Petitioner argued a POSITA would naturally look to foundational patents like Meadows, also incorporated by reference, for standard techniques like using impedance to verify electrode integrity.
  • Expectation of Success: A POSITA would have a high expectation of success in making this combination. The proposed modifications involved integrating known, proven techniques into a conventional SCS system architecture using standard, compatible hardware components that all three references employed. The combination was alleged to be a predictable implementation of known solutions to solve known problems.

4. Arguments Regarding Discretionary Denial

• Petitioner argued that discretionary denial under 35 U.S.C. §314(a), considering the Fintiv factors, would be inappropriate. The petition asserted that the co-pending district court litigation was in its early stages regarding the ’665 patent, which was asserted in counterclaims for which fact discovery was just beginning and no claim construction briefing had been filed. Petitioner noted that the district court had previously granted stays in related proceedings at the Patent Owner’s request, suggesting a stay would be likely if this IPR were instituted. Furthermore, the IPR challenges all 21 claims while the litigation asserts only 12, arguing that the IPR would be a more efficient forum for resolving the patent’s validity. Petitioner also stipulated that it would not pursue the same invalidity grounds in district court if the IPR is instituted, mitigating concerns of duplicative efforts.

5. Relief Requested

• Petitioner requests institution of an inter partes review and cancellation of claims 1-21 of Patent 10,076,665 as unpatentable.