LivaNova Inc v. Neuro Cardiac Technologies LLC

1. Case Identification

• Case #: IPR2019-00264
• Patent #: 7,076,307
• Filed: November 12, 2018
• Petitioner(s): Livanova, Inc. and Livanova USA, Inc.
• Patent Owner(s): Neuro and Cardiac Technologies, LLC
• Challenged Claims: 1-12 and 18-28

2. Patent Overview

• Title: Method and System for Modulating the Vagus Nerve
• Brief Description: The ’307 patent discloses a method and system for neuromodulation, specifically applying pulsed electrical stimulation to the vagus nerve to treat neurological and neuropsychiatric disorders. The system comprises an implantable pulse generator (IPG) and external programming components.

3. Grounds for Unpatentability

Ground 1: Obviousness over Meadows, Rutecki, and Webster - Claims 1-5, 7-12, and 18-28 are obvious over Meadows in view of Rutecki and Webster.

• Prior Art Relied Upon: Meadows (Patent 6,381,496), Rutecki (Patent 5,330,515), and Webster (a 1995 textbook titled Design of Cardiac Pacemakers).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Meadows taught a programmable IPG for neurostimulation that stores multiple, patient-selectable "operational parameter sets" (i.e., therapy programs) to improve patient convenience. Rutecki taught the specific application of an IPG for vagus nerve stimulation (VNS) to treat chronic pain, a neurological disorder. The combination of Meadows and Rutecki thus disclosed an IPG for VNS that stores multiple therapy programs. Petitioner asserted that Webster, a well-known textbook on the closely related technology of cardiac pacemakers, taught the specific structure for the "programmer means" with bi-directional inductive telemetry recited in independent claims 1 and 18.
  • Motivation to Combine: A person of ordinary skill in the art (POSITA) would combine the teachings of Meadows and Rutecki because both addressed treating chronic neuropathic pain with implantable neurostimulators. A POSITA would have been motivated to apply the patient-convenience features of Meadows (storing multiple, user-selectable therapy programs) to the known VNS therapy of Rutecki to create a more versatile and user-friendly VNS device. Because Meadows described its telemetry functions broadly, a POSITA would have turned to a standard reference like Webster to implement the well-known details of a programmer with bi-directional inductive telemetry, a common feature in the analogous field of pacemakers.
  • Expectation of Success: The combination was predictable, as IPGs for VNS were functionally similar to those for other neuromodulation applications (like in Meadows) and pacemakers (like in Webster). Applying the known programming and telemetry technologies from Webster to the combined Meadows/Rutecki VNS system would have involved only routine engineering.

Ground 2: Obviousness over Meadows, Rutecki, Webster, and Lee - Claim 6 is obvious over the combination of Meadows, Rutecki, and Webster further in view of Lee.

• Prior Art Relied Upon: Meadows (Patent 6,381,496), Rutecki (Patent 5,330,515), Webster (1995 textbook), and Lee (Patent 6,442,432).

• Core Argument for this Ground:

  • Prior Art Mapping: This ground built upon Ground 1 to address the limitations of dependent claim 6, which added "telemetry means for remote device interrogation and/or programming over a wide area network." Petitioner argued that Webster taught the concept of remote programming by suggesting its programmer could be modified with a computer modem for communication over a telephone link to save patients an office visit. Lee provided the explicit implementation details for such a system, disclosing an interface device for remote monitoring and programming of various implantable medical devices, including neurological stimulators, over a wide area network (WAN).
  • Motivation to Combine: A POSITA, seeking to implement the remote programming benefits described in Webster, would have been motivated to consult a reference like Lee. Lee provided a detailed technical blueprint for a networked communication system that achieved the exact functionality Webster proposed. Since Lee explicitly stated its applicability to neurological stimulators, a POSITA would have found it directly relevant for implementing remote capabilities for the VNS system of the primary combination.
  • Expectation of Success: There was a high expectation of success because Lee provided a detailed architecture for networked remote programming, directly addressing the functional concept taught by Webster and solving a known need in the field of implantable device management.

• Additional Grounds: Petitioner asserted additional obviousness challenges (Grounds 3 and 4) that added Salmons (a 2001 technical article) to the primary combinations. These grounds were presented as an alternative to address a potentially narrower claim construction requiring therapy programs to be stored in the IPG before device assembly, a practice explicitly taught by Salmons.

4. Key Claim Construction Positions

• "programmer means for activating and/or programming..." (claims 1 and 18): Petitioner argued this was a means-plus-function term. The claimed function was activating and/or programming the IPG using bi-directional inductive telemetry. The corresponding structure, disclosed in the ’307 patent (e.g., Fig. 47), was asserted to be substantively identical to the programmer structure disclosed in the Webster textbook, which therefore taught this limitation.
• "predetermined/pre-packaged programs" (claims 1 and 18): Petitioner argued for a broad construction where these therapy programs could be stored in the IPG's memory at any time, including after implantation. This position was based on the patent’s specification, the prosecution history, and, critically, the Patent Owner’s own interpretation as revealed in infringement contentions from a related district court case.

5. Arguments Regarding Discretionary Denial

• Petitioner argued that discretionary denial under 35 U.S.C. §314(a) would be inappropriate, despite this being a second IPR petition against the same patent. Petitioner contended that this petition challenged new claims (9 and 24) not included in the first IPR. Furthermore, the petition was filed shortly after the first and before the Patent Owner's Preliminary Response was due, minimizing inefficiency. Crucially, Petitioner argued that the Patent Owner’s recently-served infringement contentions in parallel litigation provided new information clarifying the asserted scope of the "predetermined/pre-packaged programs" term, which directly informed the invalidity arguments presented in this second petition.

6. Relief Requested

• Petitioner requested the institution of an inter partes review and the cancellation of claims 1-12 and 18-28 of the ’307 patent as unpatentable.