PTAB

IPR2019-00408

Cardiovascular Systems Inc v. Shockwave Medical Inc

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Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Shockwave Balloon Catheter with Multiple Shockwave Sources
  • Brief Description: The ’673 patent relates to an angioplasty catheter system using multiple shockwave sources, comprising pairs of electrodes, located within a fluid-fillable balloon. When a high-voltage pulse is applied, the electrodes generate shockwaves in the fluid to treat calcified plaque in blood vessels.

3. Grounds for Unpatentability

Ground 1: Obviousness over Hawkins/Kunis Combination - Claims 1, 2, 5-8, 15, 16, 19, and 20 are obvious over Hawkins ’020 in view of Hawkins ’768 and Kunis.

  • Prior Art Relied Upon: Hawkins ’020 (Application # 2010/0114020), Hawkins ’768 (Application # 2009/0312768), and Kunis (Patent 7,850,685).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Hawkins ’020, which shares an inventor with the ’673 patent, discloses the foundational shockwave balloon catheter system with a plurality of electrode pairs. The petition contended that the primary limitations added during prosecution to overcome rejections based on Hawkins ’020 were: (1) a series electrical connection between electrode pairs, and (2) one electrode in each pair having a larger surface area than the other. Petitioner asserted that Hawkins ’768, also from the same inventor, taught the use of electrodes with different surface areas, such as a parabolic reflector electrode that is inherently larger than its corresponding coaxial center electrode. To address the series connection, Petitioner relied on Kunis, which teaches ablation catheters with multiple electrodes and explicitly discloses connecting them in series, parallel, or combinations thereof.
    • Motivation to Combine (for §103 grounds): A person of ordinary skill in the art (POSITA) would combine the teachings of Hawkins ’020 and Hawkins ’768 because they are from the same inventive entity and address the same technical problem. A POSITA would have been motivated to look to analogous arts, such as the ablation catheters in Kunis, to solve the known problem of managing wiring for multiple electrodes in a confined intravascular space. Kunis taught that a series connection was a known solution to reduce the number and bulk of conductors, providing a clear motivation to apply this established electrical principle to the multi-electrode system of Hawkins ’020.
    • Expectation of Success (for §103 grounds): A POSITA would have a reasonable expectation of success in implementing these modifications, as they involved applying well-understood electrical engineering principles (series connections) and known component designs (asymmetrical electrodes) to a shockwave catheter, resulting in a predictable and functional device.

Ground 2: Obviousness with Multiplexer - Claims 3, 4, 9-14, 17, and 18 are obvious over Hawkins ’020 in view of Hawkins ’768, Kunis, and Lesh.

  • Prior Art Relied Upon: Hawkins ’020 (Application # 2010/0114020), Hawkins ’768 (Application # 2009/0312768), Kunis (Patent 7,850,685), and Lesh (Application # 2005/0251131).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground built upon the combination in Ground 1 to address claims requiring additional electrode pairs and a multiplexer for selective activation. Petitioner argued that the addition of more electrode pairs was a simple and obvious duplication of parts to treat larger lesion areas, a concept also taught by Kunis. The key addition for this ground, Lesh, was cited for its explicit teaching of using a multiplexer to selectively connect a power source to different electrodes in an intravascular device. Petitioner noted that the Patent Owner admitted during prosecution that it did not invent multiplexing.
    • Motivation to Combine (for §103 grounds): A POSITA, having combined the Hawkins references with Kunis to create a system with multiple serially-connected electrode pairs, would be motivated to incorporate a multiplexer for enhanced control. Lesh provided a known method for selectively activating different sets of electrodes, which would be a desirable feature for treating specific sections of a vessel. The motivation was to improve the functionality and control of the multi-electrode device using a standard, well-known switching component.
    • Expectation of Success (for §103 grounds): Integrating a multiplexer into an electrical circuit for an intravascular device was a routine design choice well within the skill of a POSITA. The function of a multiplexer is predictable, and its successful implementation in the proposed catheter system would have been reasonably expected.

4. Relief Requested

  • Petitioner requests institution of an inter partes review (IPR) and cancellation of claims 1-20 of the ’673 patent as unpatentable under 35 U.S.C. §103.