PTAB

IPR2019-01340

Nevro Corp v. Boston Scientific Neuromodulation Corp

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Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Parameter Context Switching for an Implanted Device
  • Brief Description: The ’496 patent relates to implantable medical devices, such as spinal cord stimulators, that can store and switch between multiple sets of operational parameters. This "context switching" allows a user to change the device's therapeutic output by selecting a different pre-defined parameter set using an external programmer.

3. Grounds for Unpatentability

Ground 1: Obviousness over Shelton and Nappholz - Claims 1-3 and 6 are obvious over Shelton in view of Nappholz.

  • Prior Art Relied Upon: Shelton (Patent 5,387,228) and Nappholz (Patent 5,720,770).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Shelton, a patent on cardiac pacemakers, disclosed all elements of independent claim 1 except for a "plurality of sets of operational parameters." Shelton taught an implantable device with an implantable case, electronic circuitry, a control register for storing a single control set of parameters, and a controller that operates the device based on those parameters. Petitioner asserted that Nappholz, also in the cardiac pacing field, explicitly taught the missing element: storing and using multiple sets of operational parameters corresponding to different patient activities (e.g., sleeping, exercise). Nappholz’s different "modes of operation" were argued to be equivalent to the claimed "plurality of sets of operational parameters."
    • Motivation to Combine: Petitioner argued a person of ordinary skill in the art (POSITA) would combine Nappholz’s teaching of multiple parameter sets with Shelton’s pacemaker system to improve its flexibility and ease of use for the patient. This combination was presented as a predictable solution, using a known technique (multiple parameter sets from Nappholz) to improve a similar device (Shelton's pacemaker).
    • Expectation of Success: Petitioner asserted a POSITA would have a reasonable expectation of success because Shelton itself stated that one of skill in the art could choose from various available programming techniques to practice the invention, and both references operated in the analogous field of implantable cardiac devices.

Ground 2: Obviousness over Nappholz - Claims 8-13 are obvious over Nappholz.

  • Prior Art Relied Upon: Nappholz (Patent 5,720,770).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner contended that Nappholz alone rendered the method claims 8-13 obvious. Independent claim 8 recites a method of changing operational parameters by defining, storing, selecting, and providing a control set of parameters to an implant device. Petitioner mapped these steps to Nappholz's disclosure of a physician using an external "Repeater, Programmer, and Phone" (RPP) to define different "modes of operation" (the sets of parameters), which are then stored in and transmitted to the implantable device. The patient could then select a different mode based on their activity level, thereby changing the device's operation. Dependent claims, such as defining sets within safe operating limits (claim 9) and storing them externally (claim 11), were also argued to be disclosed in Nappholz’s system, which required physician customization for patient safety and utilized an external RPP with memory.

Ground 3: Obviousness over Barreras I - Claim 14 is obvious over Barreras I.

  • Prior Art Relied Upon: Barreras I (Patent 5,591,217).

  • Core Argument for this Ground:

    • Prior Art Mapping: Petitioner argued that Barreras I, which described an implantable tissue simulator system, rendered system claim 14 obvious. Independent claim 14 recites an implant system with an implant device containing electronic circuitry, a first memory for storing operational parameters, and a replenishable power source. It also requires an external control device for transferring control data and an external charging device. Petitioner argued that Barreras I disclosed all of these elements. It taught an implanted stimulator (the implant device) with memory, a rechargeable power source, and telemetry circuits. Barreras I also disclosed an external programmer unit for sending programming data (the control device) and a separate external "refresh-recharge" transmitter for recharging the internal power source (the charging device).

  • Additional Grounds: Petitioner asserted additional obviousness challenges, including claims 4-5 over Shelton, Nappholz, and Mumford (Patent 4,432,360) for adding user-specific access controls; claim 7 over Shelton, Nappholz, and Barreras II (Patent 5,735,887) for adding specific parameter types like ramp rate; claims 15-16 over Barreras I and Nappholz; and claims 17-18 over Barreras I, Nappholz, and Mumford.

4. Key Claim Construction Positions

  • Petitioner argued that no terms required explicit construction beyond their plain and ordinary meaning. However, for several means-plus-function limitations, Petitioner identified the corresponding structure disclosed in the ’496 patent to guide the invalidity analysis.
  • "selection means" (claim 1): Petitioner identified the corresponding structure as the combination of a hand-held programmer (HHP) and the microcontroller within the implanted device, which work together to select and implement a chosen operational parameter set.
  • "memory access control means" (claim 2): Petitioner identified the corresponding structure as the memory access control circuit (element 163 in Fig. 6 of the ’496 patent), which retrieves a selected parameter set from memory and loads it into the control register.
  • "change means" (claim 4): Petitioner identified the corresponding structure as the user interface on the HHP, such as buttons on a keypad or a display screen, that allows a user to select and change parameters.

5. Relief Requested

  • Petitioner requested the institution of an inter partes review and the cancellation of claims 1-18 of the ’496 patent as unpatentable.