DCT
4:18-cv-01517
Neuro Cardiac Tech LLC v. LivaNova Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Neuro and Cardiac Technologies, LLC (Delaware)
- Defendant: LivaNova, Inc. (California) and LivaNova USA, Inc. (Delaware)
- Plaintiff’s Counsel: Nelson Bumgardner Albritton P.C.
- Case Identification: 4:18-cv-01517, S.D. Tex., 05/11/2018
- Venue Allegations: Venue is alleged to be proper in the Southern District of Texas based on Defendants maintaining a permanent physical presence and a regular and established place of business in Houston.
- Core Dispute: Plaintiff alleges that Defendant’s Vagus Nerve Stimulation (VNS) Therapy System, used for treating epilepsy, infringes a patent related to methods and systems for modulating the vagus nerve with electrical pulses using implantable and external components.
- Technical Context: The technology involves implantable neurostimulators that deliver programmed electrical pulses to the vagus nerve to treat neurological and neuropsychiatric disorders.
- Key Procedural History: The complaint alleges that Defendant had pre-suit knowledge of the patent-in-suit since at least 2010, based on its predecessor, Cyberonics, Inc., having cited the patent in Information Disclosure Statements filed during the prosecution of its own patents.
Case Timeline
| Date | Event |
|---|---|
| 2002-05-09 | '307 Patent Priority Date |
| 2006-07-11 | '307 Patent Issue Date |
| 2010-04-30 | Alleged date of Defendant's knowledge of '307 Patent |
| 2017-10-09 | FDA approval for Accused SenTiva Device |
| 2018-05-11 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 7,076,307 - "Method and System for Modulating the Vagus Nerve (10th Cranial Nerve) with Electrical Pulses Using Implanted and External Components, To Provide Therapy Neurological and Neuropsychiatric Disorders"
- Patent Identification: U.S. Patent No. 7,076,307, "Method and System for Modulating the Vagus Nerve (10th Cranial Nerve) with Electrical Pulses Using Implanted and External Components, To Provide Therapy Neurological and Neuropsychiatric Disorders," issued July 11, 2006.
The Invention Explained
- Problem Addressed: The patent describes the need for alternative therapies for various neurological and neuropsychiatric disorders, such as epilepsy and depression, and identifies the vagus nerve as an accessible peripheral route for modulating central nervous system function (’307 Patent, col. 1:41-54).
- The Patented Solution: The invention is a system that uses an implantable pulse generator (IPG) to deliver controlled electrical pulses to the vagus nerve. The IPG contains a microprocessor and memory to store and execute different stimulation programs, which define parameters like pulse amplitude, width, and frequency (’307 Patent, Abstract). A key aspect is the use of an external programmer that communicates with the implant via bi-directional telemetry to activate, program, and modify these therapeutic routines (’307 Patent, col. 7:55-62).
- Technical Importance: This approach provides a programmable and adjustable method for neuromodulation therapy, allowing for treatment to be tailored to individual patients for a range of difficult-to-treat conditions (’307 Patent, col. 6:33-51).
Key Claims at a Glance
- The complaint asserts independent claims 1 (a method claim) and 18 (a system claim) (’307 Patent, col. 33:1-34:28; Compl. ¶76).
- Independent claim 18 recites a system comprising:
- An implantable pulse generator (IPG) with a microprocessor, circuitry, memory, and power source.
- At least two "predetermined/pre-packaged programs" stored in the IPG's memory to control electrical pulses, defining parameters like amplitude, width, frequency, on-time, and off-time.
- An implantable lead connecting the IPG to at least one electrode adapted for contact with the vagus nerve.
- A "means for activating and/or programming" the IPG using bi-directional inductive telemetry to exchange data.
- The complaint also asserts numerous dependent claims and indicates it may pursue other claims not explicitly listed (Compl. ¶76).
III. The Accused Instrumentality
Product Identification
- The "VNS Therapy System" when used with the "SenTiva" implantable pulse generator (also known as "Model 1000") (Compl. ¶¶20-21).
Functionality and Market Context
- The Accused Product is a medical device system used to treat drug-resistant epilepsy through vagus nerve stimulation (Compl. ¶22). It consists of the implantable SenTiva generator, an implantable lead, and an external programming system that includes a computer, software, and a programming wand (Compl. ¶25).
- The SenTiva generator is described as an implantable, multiprogrammable pulse generator containing a microprocessor, memory, CMOS circuitry, and a battery (Compl. ¶¶26, 27, 30, 31). A block diagram from the product's Physician's Manual, "Figure 33. Generator Circuitry," is included in the complaint to illustrate these components (Compl. ¶29).
- The system allows physicians to program multiple therapy settings, including a "Day-Night Programming" feature that enables the generator to deliver two independent sets of therapy parameters at different times during a 24-hour period (Compl. ¶35). The complaint also references a graphic from Defendant's website illustrating three modes of therapy, including a "Standard Mode" for preventative delivery (Compl. ¶37).
- Communication between the external programmer and the implanted SenTiva generator occurs via bi-directional inductive telemetry (Compl. ¶¶56-57).
IV. Analysis of Infringement Allegations
’307 Patent Infringement Allegations
| Claim Element (from Independent Claim 18) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| an implantable pulse generator comprising microprocessor, circuitry, memory, and power source | The Accused Product includes the SenTiva, an implantable pulse generator that comprises a microprocessor, CMOS integrated circuits, internal memory, and a battery as a power source. | ¶26, ¶27, ¶29, ¶30, ¶31 | col. 33:59-67 |
| at least two predetermined/pre-packaged programs of stimulation therapy stored in said memory to control said electrical pulses... | The SenTiva generator supports "Day-Night Programming," which stores and alternates between two independent, physician-defined sets of therapy parameters. It also includes a pre-programmed "Standard Mode." | ¶33, ¶35, ¶36, ¶37 | col. 19:20-33 |
| an implantable lead in electrical contact with said implantable pulse generator wherein said lead comprising at least one electrode adapted to be in contact with said vagus nerve(s) | The VNS Therapy System includes an implantable lead with helical electrodes made of platinum/iridium alloy. The complaint includes "Figure 96. Electrode Placement" from a manual, showing the lead is designed to be placed in contact with a patient's vagus nerve. | ¶45, ¶49, ¶51, ¶52, ¶55 | col. 16:9-23 |
| means for activating and/or programming said implantable pulse generator, wherein bi-directional inductive telemetry is used to exchange data with said implantable pulse generator | The Accused Product includes an external programming system with a wand and tablet that communicates with the SenTiva generator using bi-directional inductive telemetry to program the device and retrieve data. | ¶25, ¶56, ¶57 | col. 26:60-65 |
Identified Points of Contention
- Scope Questions: A primary issue for the court may be the interpretation of "predetermined/pre-packaged programs." The question arises whether the accused product's "Day-Night Programming," which allows a physician to define and store two custom therapy routines, falls within the scope of this term, or if the term is limited to fixed, manufacturer-defined programs like the "LOW, MED, HIGH" examples in the patent specification.
- Technical Questions: The complaint relies heavily on the defendant's own technical manuals and marketing materials, creating a strong factual basis for its infringement allegations. Therefore, disputes may be less about how the accused product operates and more about whether that operation meets the specific limitations of the claims as construed by the court.
V. Key Claim Terms for Construction
The Term: "predetermined/pre-packaged programs"
- Context and Importance: The infringement reading for this element depends on whether a program must be set by the manufacturer ("pre-packaged") or can be defined by a user (e.g., a physician) and then stored for automatic execution ("predetermined"). Practitioners may focus on this term because the accused functionality involves physician-defined parameter sets, which LivaNova may argue are not "pre-packaged."
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent states that "each parameter may be individually programmed and stored in memory," and that the microprocessor "controls the program parameters of the device" such as pulse width and frequency, suggesting that user-programmability is a core feature (’307 Patent, col. 20:13-17, 65-67).
- Evidence for a Narrower Interpretation: The specification provides specific examples of programs as named "states," such as "LOW stimulation state example," "MED stimulation state example," and "HIGH stimulation state example," each with specific parameter values listed (’307 Patent, col. 19:35-64). This could support an argument that the term refers to built-in, non-user-modifiable presets.
The Term: "means for activating and/or programming said implantable pulse generator"
- Context and Importance: As a means-plus-function term, its scope is not limitless but is confined to the structures disclosed in the specification for performing the recited function, and their equivalents. The infringement analysis will depend on whether the accused external programmer (tablet and wand) is structurally equivalent to the programmer disclosed in the patent.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent describes the function broadly as using "bi-directional inductive telemetry" to "exchange data" with an "external programming unit 85" (’307 Patent, col. 26:60-65). This focus on the communication protocol could support a wider range of equivalent hardware structures.
- Evidence for a Narrower Interpretation: The specific structure shown is an "external programmer 85" communicating via telemetry coils (FIG. 34, FIG. 47) and an alternative embodiment using a magnet and reed switch to cycle through states (FIG. 31, FIG. 32). An argument could be made that the scope is limited to these specific types of hardware implementations and their direct equivalents.
VI. Other Allegations
Indirect Infringement
- The complaint alleges induced infringement under 35 U.S.C. § 271(b), asserting that LivaNova provides product manuals and instructions (e.g., the "Physician's Manual") that actively encourage and instruct its customers to use the VNS Therapy System in an infringing manner (Compl. ¶¶62, 77). It also alleges contributory infringement under § 271(c), claiming the SenTiva generator is a material part of the invention, is not a staple article of commerce, and has no substantial non-infringing uses (Compl. ¶64).
Willful Infringement
- Willfulness is alleged based on LivaNova's purported pre-suit knowledge of the ’307 Patent. The complaint claims this knowledge dates back to at least April 30, 2010, and stems from Information Disclosure Statements that cited the ’307 Patent during the prosecution of patents owned by LivaNova or its predecessor, Cyberonics (Compl. ¶¶66, 68-70).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: can the term "predetermined/pre-packaged programs," which the patent illustrates with manufacturer-defined examples, be construed to cover the physician-customized and storable therapy settings of the accused "Day-Night Programming" feature?
- A second central question will be one of structural equivalence: for the means-plus-function claim term "means for activating and/or programming," is the accused system’s modern programmer, comprising a tablet and wireless wand, legally equivalent to the specific programmer and magnet-based hardware configurations disclosed in the 2002-priority-date patent?
- The viability of the willfulness claim will likely depend on an evidentiary determination: does the allegation that the ’307 Patent was cited in Defendant’s own patent prosecution history establish the requisite knowledge and intent for willful infringement, or can Defendant successfully argue it had good-faith beliefs of non-infringement or invalidity?