Boston Scientific Corp v. Nevro Corp

1. Case Identification

• Case #: IPR2022-00512
• Patent #: 10,576,286
• Filed: February 15, 2022
• Petitioner(s): Boston Scientific Corporation, and Boston Scientific Neuromodulation Corporation
• Patent Owner(s): Nevro Corporation
• Challenged Claims: 1-12

2. Patent Overview

• Title: Spinal Cord Modulation for Inhibiting Pain Via Short Pulse Width Waveforms, and Associated Systems and Methods
• Brief Description: The ’286 patent discloses methods and systems for spinal cord stimulation (SCS) to inhibit pain without causing paresthesia (a tingling sensation). The technology involves programming an implantable pulse generator to deliver a therapy signal with specific parameters, including short pulse widths, to the patient's dorsal column.

3. Grounds for Unpatentability

Ground 1: Obviousness over Alataris675 and Lee459 - Claims 1-12 are obvious over Alataris675 in view of 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, like the ’286 patent, taught an SCS system for providing pain relief without paresthesia. Alataris675 allegedly disclosed all limitations of independent claim 1 except for the specific frequency range. It disclosed using short pulse widths (e.g., 30-35 µs) and low amplitudes (e.g., 1-4 mA) to deliver non-paresthesia-producing therapy via leads placed near the spinal cord midline. Petitioner asserted that Lee459 explicitly taught using the claimed frequency range (less than 1,500 Hz, encompassing 500-1,200 Hz) in combination with the claimed pulse widths (preferably 10-50 µs) for the express purpose of generating non-paresthesia-producing therapy.
  • Motivation to Combine: A Person of Ordinary Skill in the Art (POSA) would combine these references to solve a known problem. Petitioner contended that the high-frequency therapy in Alataris675 consumed excessive energy, a problem Lee459 recognized and solved by proposing a lower-frequency therapy (below 1,500 Hz) while maintaining the same effective short pulse widths (10-50 µs) to minimize energy consumption without sacrificing the non-paresthetic effect.
  • Expectation of Success: A POSA would have a strong expectation of success because both references described using standard, commercially available SCS hardware. The combination involved modifying only known, programmable parameters (frequency, pulse width) in a predictable manner to achieve the desired, explicitly stated result of energy-efficient, non-paresthesia-producing pain relief.

Ground 2: Obviousness over Alataris675 and Shaw - Claims 1-12 are obvious over Alataris675 in view of Shaw.

• Prior Art Relied Upon: Alataris675 (Patent 8,170,675) and Shaw (a 2012 conference publication).
• Core Argument for this Ground:
  • Prior Art Mapping: Similar to the first ground, Petitioner argued Alataris675 provided the foundational SCS system for non-paresthesia therapy but lacked the claimed frequency. Shaw was alleged to supply this missing element, as it described programming a Boston Scientific SCS system to deliver non-paresthesia-producing therapy using a specific frequency of 1,200 Hz and a pulse width of 40 µs—parameters that fall squarely within the ranges of challenged claim 1. Shaw also disclosed placing a bipole lead close to the midline to deliver the therapy, mapping to the claim limitation of transmitting the signal to the dorsal column.
  • Motivation to Combine: A POSA would combine Alataris675 with Shaw to find alternative, effective parameters for non-paresthesia therapy. Shaw expressly stated that using 1.2 kHz sub-sensory threshold stimulation "may offer benefits to patients that are not satisfied with treatment at lower frequencies." This provided a direct suggestion to a POSA to try the specific parameters taught in Shaw with a known non-paresthesia SCS system like the one described in Alataris675 to improve patient outcomes.
  • Expectation of Success: The combination was a predictable application of known techniques. Shaw demonstrated successful pain relief using a commercially available SCS system, confirming the viability of its parameters. A POSA would reasonably expect that applying Shaw's successful 1,200 Hz / 40 µs parameter set to the non-paresthesia therapy method of Alataris675 would yield the expected result of effective pain relief without paresthesia.

Ground 3: Obviousness over Lee459 Alone - Claims 1-12 are obvious over Lee459.

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

• Core Argument for this Ground:

  • Prior Art Mapping: Petitioner argued that Lee459 alone rendered all challenged claims obvious because it taught every claimed element. Specifically, Lee459 disclosed a programmable SCS system for reducing pain without paresthesia by using a frequency "less than 1500 Hz" (which inherently discloses the 500-1,200 Hz range) and a pulse width "most preferably equal to or less than 50 µs" and "greater than 10 µs." Lee459 further taught programming the amplitude to a sub-threshold level to avoid paresthesia, which would inevitably fall within the broad 0.5-20 mA claimed range. Finally, Petitioner asserted that Lee459's disclosure of placing leads "as close to the anatomical midline as possible" would be understood by a POSA to result in transmitting the therapy signal to the dorsal column.
  • Key Aspects: This ground asserted that no combination was necessary because a single reference taught the entire claimed method. Petitioner argued that the ’286 patent provided no details beyond what was already disclosed in Lee459 regarding how to program the device to achieve the claimed therapy.

• Additional Grounds: Petitioner asserted additional obviousness challenges, including combinations adding Eddicks (a 2007 journal article) to provide more detailed instructions on achieving sub-threshold, non-paresthetic stimulation, and a combination of Lee459 and Shaw. These grounds relied on similar rationales for combining known parameters to achieve predictable results.

4. Arguments Regarding Discretionary Denial

• Petitioner argued that the Board should not exercise its discretion to deny institution under 35 U.S.C. §314(a) or §325(d).
• Fintiv Factors (§314(a)): Petitioner contended that the co-pending district court litigation was in its infancy, with a trial date more than a year away and well after a Final Written Decision in the inter partes review (IPR) would be due. Therefore, the IPR would be a more efficient resolution.
• Same Art or Arguments (§325(d)): Petitioner argued that the key prior art (Lee459 and Shaw) was not substantively considered by the Examiner during prosecution. While Lee459 was mentioned in an interview, there was no evidence of its full consideration, and Shaw was buried within a 198-page syllabus cited in an Information Disclosure Statement. Petitioner asserted the Examiner erred by accepting the Patent Owner's arguments, which were directly contradicted by these unconsidered references.

5. Relief Requested

• Petitioner requests institution of IPR and cancellation of claims 1-12 of the ’286 patent as unpatentable.