PTAB

IPR2022-00511

Boston Scientific Corp v. Nevro Corp

Log In
Key Events
Petition

1. Case Identification

2. Patent Overview

  • Title: Spinal Cord Modulation for Inhibiting Pain Via Short Pulse Width Waveforms, and Associated Systems and Methods
  • Brief Description: The ’112 patent is directed to a spinal cord stimulation (SCS) system for inhibiting pain without causing paresthesia. Independent claim 1 recites a system comprising an implantable signal generator that produces a non-paresthesia-producing therapy signal, and a signal delivery device to apply the signal to the patient's dorsal column. The therapy signal is defined by a specific combination of parameters: a frequency from 500 Hz to 1,200 Hz, a pulse width from 10 to 50 microseconds, and a current amplitude from 0.5 mA to 7 mA.

3. Grounds for Unpatentability

Ground 1: Obviousness over Alataris675 and Lee459

  • Prior Art Relied Upon: Alataris675 (Patent 8,170,675) and Lee459 (Patent 9,002,459).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Alataris675 disclosed a complete SCS system for providing non-paresthesia pain relief, teaching all limitations of claim 1 except the specific frequency range. Alataris675 taught using short pulse widths (e.g., 30-35 µs) and amplitudes within the claimed range (e.g., 0.1-6 mA) with standard implantable generators and leads. Lee459 supplied the missing frequency element, teaching the use of frequencies "less than 1,500 Hz" in combination with short pulse widths "preferably in the range of 10 µs-50 µs" for the express purpose of achieving non-paresthesia pain relief. Dependent claims reciting features like duty cycles and square waves were alleged to be disclosed in Alataris675 or otherwise well-known in the art.
    • Motivation to Combine: A POSITA would combine the references to improve upon the high-frequency therapy in Alataris675, which consumed excessive energy. Lee459 expressly identified this energy consumption problem and proposed the solution of using lower frequencies (<1,500 Hz) while maintaining the short pulse widths taught by Alataris675 to achieve the same therapeutic effect with greater efficiency.
    • Expectation of Success: A POSITA would have had a strong expectation of success because both references taught using standard SCS systems and routine programming to achieve non-paresthesia pain relief, and Lee459 expressly disclosed that its proposed frequency and pulse width combinations were effective.

Ground 2: Obviousness over Alataris675 and Shaw

  • Prior Art Relied Upon: Alataris675 (Patent 8,170,675) and Shaw (a 2012 North American Neuromodulation Society abstract and poster).
  • Core Argument for this Ground:
    • Prior Art Mapping: As in the previous ground, Alataris675 provided the baseline non-paresthesia SCS system, including the claimed pulse width and amplitude ranges. Shaw supplied the missing frequency limitation, disclosing a study that used a Boston Scientific SCS system programmed at a frequency of 1,200 Hz with a 40 µs pulse width to provide effective, non-paresthesia pain relief. Shaw also taught the claimed method of delivering the signal to the dorsal column via midline lead placement.
    • Motivation to Combine: Petitioner asserted that Shaw provided an express motivation to combine, stating that "more investigation is needed into these programming parameters" and that its 1.2 kHz stimulation "may offer benefits to patients that are not satisfied with treatment at lower frequencies." This would have motivated a POSITA to apply Shaw's successful parameters to a known non-paresthesia system like that disclosed in Alataris675 to explore improved patient outcomes.
    • Expectation of Success: Success was expected because Shaw demonstrated positive clinical results using the specific parameters, and combining them with Alataris675's system involved only routine programming adjustments on a known device type.

Ground 3: Obviousness over Lee459 alone

  • Prior Art Relied Upon: Lee459 (Patent 9,002,459).

  • Core Argument for this Ground:

    • Prior Art Mapping: Petitioner argued Lee459 alone disclosed all limitations of the challenged claims. It taught an SCS system for non-paresthesia pain relief using frequencies "less than 1500 Hz" and pulse widths "most preferably equal to or less than 50 µs" and "greater than 10 µs," which directly map onto the claimed parameter ranges. For amplitude, Lee459 taught programming below the patient's paresthesia threshold. Petitioner contended that this teaching, when viewed with the knowledge of a POSITA regarding average paresthesia thresholds in the art, rendered the claimed 0.5-7 mA range obvious. Lee459's disclosure of placing leads "as close to the anatomical midline as possible" was argued to inherently deliver the therapy signal to the dorsal column.

  • Additional Grounds: Petitioner asserted additional obviousness challenges, including claims 1-12 over Alataris675, Lee459, and Eddicks; over Alataris675, Shaw, and Eddicks; and over Lee459 and Shaw. These grounds primarily used Eddicks to provide further detail on programming subthreshold amplitudes or Shaw to provide a specific frequency data point, reinforcing the core combination arguments.

4. Arguments Regarding Discretionary Denial

  • Petitioner argued against discretionary denial under 35 U.S.C. §314(a) based on Fintiv, asserting the parallel district court litigation was in its infancy, with a trial date that would occur long after a Final Written Decision, making denial inappropriate.
  • Petitioner also argued against denial under 35 U.S.C. §325(d), contending that the key prior art (Lee459, Shaw, Eddicks) was not substantively considered during prosecution. Petitioner alleged the Patent Owner misrepresented the teachings of Lee459 to the Examiner and failed to highlight the contradictory disclosures in Shaw, leading the Examiner to err in a manner material to patentability by allowing the claims.

5. Relief Requested

  • Petitioner requests institution of an inter partes review and cancellation of claims 1-12 of Patent 10,556,112 as unpatentable.