DCT
2:19-cv-00167
Neuro Cardiac Tech LLC v. Neuronetics Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Neuro and Cardiac Technologies, LLC (Wisconsin)
- Defendant: Neuronetics, Inc. (Delaware)
- Plaintiff’s Counsel: Dilworth Paxson LLP
- Case Identification: 2:19-cv-00167, E.D. Pa., 01/11/2019
- Venue Allegations: Plaintiff alleges venue is proper in the Eastern District of Pennsylvania because Defendant maintains its principal place of business and a permanent physical presence within the district.
- Core Dispute: Plaintiff alleges that Defendant’s NeuroStar TMS Therapy System infringes a patent related to an external stimulator that provides neuromodulation treatment using pre-determined programs.
- Technical Context: The technology concerns external medical devices that use electrical or magnetic pulses to stimulate nerve tissue for the treatment of neurological and neuropsychiatric disorders like major depression.
- Key Procedural History: The complaint alleges that Defendant has had knowledge of the patent-in-suit since at least November 2004, citing numerous instances where the patent was included in Information Disclosure Statements (IDS) during the prosecution of Defendant’s own patents. These allegations form the primary basis for the claim of willful infringement.
Case Timeline
| Date | Event |
|---|---|
| 1998-10-26 | '814 Patent Priority Date |
| 2002-04-02 | '814 Patent Issue Date |
| 2003 | Defendant Neuronetics, Inc. founded |
| 2004-11-22 | Earliest date Defendant allegedly knew of '814 Patent |
| 2008 | First sale of Accused Product (NeuroStar System) |
| 2019-01-11 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 6,366,814 - External Stimulator for Adjunct (Add-On) Treatment for Neurological, Neuropsychiatric, and Urological Disorders
The Invention Explained
- Problem Addressed: The patent addresses drawbacks of fully implanted neurostimulators, which are used to treat disorders like epilepsy and depression. A key problem identified is the limited battery life of such implants, which leads to frequent, costly, and burdensome surgical procedures for replacement, particularly for the younger patient populations who receive nerve stimulation therapy compared to cardiac pacemaker recipients (’814 Patent, col. 10:5-14).
- The Patented Solution: The invention proposes a system where the power source and control circuitry are housed in an external pulse generator, which is then inductively coupled to a smaller, passive implanted lead-receiver (’814 Patent, Abstract). This design is intended to eliminate the need to surgically replace the main power source. The external unit contains a limited number of pre-determined, selectable treatment programs, simplifying operation for the patient or caretaker while allowing therapy to be adjusted within defined limits (’814 Patent, col. 1:17-24; Fig. 4).
- Technical Importance: This technical approach aims to reduce the frequency of surgical interventions, lower therapy costs, and simplify device operation compared to the fully implanted, physician-programmed neurostimulators that were a focus of the prior art (’814 Patent, col. 10:15-52).
Key Claims at a Glance
- The complaint asserts infringement of "one or more claims of the ’814 Patent including at least Claim 1" (Compl. ¶52). Independent claim 1 is the focus of the allegations.
- The essential elements of independent claim 1 are:
- An external pulse generator for neuromodulation treatment of at least one of neurologic, neuropsychiatric, and urological disorders, comprising:
- a) a power source, primary coil, and circuitry to provide electrical signals; and
- b) at least two pre-determined programs to control the electrical signals generated by said pulse generator whereby neuromodulation treatment is provided.
III. The Accused Instrumentality
Product Identification
The NeuroStar TMS Therapy® System ("NeuroStar TMS System") (Compl. ¶19).
Functionality and Market Context
- The accused product is a Transcranial Magnetic Stimulation (TMS) system indicated for the treatment of Major Depressive Disorder in adult patients who have not achieved satisfactory improvement from prior antidepressant medication (Compl. ¶¶19, 27).
- The system is described as a computerized electromechanical instrument that includes an external pulse generator, a power source, and a treatment coil (Compl. ¶¶28, 34, 39). This coil generates a pulsed magnetic field to induce electrical currents in the cerebral cortex (Compl. ¶30).
- The complaint alleges the system includes multiple pre-determined treatment options. Figure 12-7 of the product's user manual shows a "TMS Prescription" window listing several available treatments, such as "Standard," "Week 1," and "Week 2" (Compl. ¶44). The complaint also notes that according to the user manual, the number of "Programmable Pulse Sequences" is limited only by the storage capacity of the system's computer (Compl. ¶45).
IV. Analysis of Infringement Allegations
'814 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An external pulse generator for neuromodulation treatment... | The NeuroStar TMS System is an external pulse generator that provides a therapeutic neuromodulation technique for the treatment of neurologic disorders such as major depression. | ¶¶31, 32 | col. 19:55-59 |
| a) a power source, primary coil, and circuitry to provide electrical signals | The system includes a power source (a 120 VAC, 20A dedicated circuit), a Treatment Coil (alleged to be the "primary coil"), and circuitry to provide electrical signals. A schematic from the user manual is provided as evidence. | ¶¶34, 36-38, 41-42 | col. 19:59-60 |
| b) at least two pre-determined programs to control the electrical signals... whereby neuromodulation treatment is provided | The system includes at least two pre-determined programs for treatment. A screenshot from the user manual shows a "TMS Prescription" window with a list of available treatments to select from. | ¶¶43, 44 | col. 19:60-64 |
Identified Points of Contention
- Scope Questions: A primary question for claim construction will be whether the claims, when read in light of the specification, are limited to systems that include an implanted component. The ’814 patent specification pervasively describes a two-part system with an external generator and an implanted lead-receiver (’814 Patent, Abstract; Fig. 4). The accused NeuroStar TMS system is entirely external. The dispute may turn on whether the term "external pulse generator" as used in claim 1 requires the presence of, or adaptation for use with, an implanted receiver to fall within the scope of the invention as a whole.
- Technical Questions: The complaint alleges the accused system’s "Treatment Coil" meets the "primary coil" limitation of claim 1 (Compl. ¶37). A technical question for the court is whether a TMS coil, which is designed to directly induce current in a patient's brain tissue, is the structural and functional equivalent of the "primary coil" described in the patent, which is designed to inductively transfer power to a corresponding secondary coil in an implanted device (’814 Patent, col. 12:47-56).
V. Key Claim Terms for Construction
The Term: "external pulse generator"
- Context and Importance: This term defines the entire apparatus of claim 1. Its construction will be dispositive, as it determines whether the claim can read on a fully external TMS system or is limited to the generator component of a two-part, implant-based system.
- Intrinsic Evidence for a Broader Interpretation: A party could argue that the plain and ordinary meaning of the term is simply a pulse generator that is external to the body. Claim 1 itself does not recite an implanted component, and limitations from the specification’s preferred embodiments should not be imported into the claims.
- Intrinsic Evidence for a Narrower Interpretation: A party could argue that the patent defines the invention as a system with an implanted component. The abstract states the generator is "adapted to be inductively coupled with an implanted lead-receiver," and the detailed description and figures consistently depict this two-part structure (’814 Patent, Abstract; Fig. 4; col. 12:47-49). This may support an interpretation that an "external pulse generator" under this patent must be one designed for use with an implant.
The Term: "pre-determined programs"
- Context and Importance: This limitation distinguishes the claimed invention from more complex, fully programmable clinical systems. The infringement analysis depends on whether the accused system's selectable treatment protocols are "pre-determined programs" as that term is used in the patent.
- Intrinsic Evidence for a Broader Interpretation: The patent describes these programs as containing a "unique combination of pulse amplitude, pulse-width, frequency of stimulation, and on-off time periods" (’814 Patent, col. 11:1-3). The screenshot from the accused product's manual appears to show selectable options with these differing parameters (Compl. ¶44), which may support a broad reading of the term.
- Intrinsic Evidence for a Narrower Interpretation: The patent repeatedly frames these programs as a "limited number... packaged into the stimulator" to simplify use for a patient or caretaker, and explicitly contrasts this with a more complex "programming station" (’814 Patent, col. 11:1-21). A party may argue that the accused system, which the complaint notes has programmable sequences "Limited only by the storage capacity of the TMS TrakStar computer" (Compl. ¶45), is the type of complex system the patent sought to distinguish itself from, not embody.
VI. Other Allegations
- Indirect Infringement: The complaint alleges inducement, asserting that Defendant sells the NeuroStar system and provides instruction manuals and website information that instruct and encourage customers to use the product in an infringing manner (Compl. ¶79).
- Willful Infringement: The complaint alleges willful infringement based on both pre-suit and post-suit knowledge. The claim of pre-suit knowledge is primarily based on the allegation that Defendant has known of the ’814 patent since "at least November 22, 2004" (Compl. ¶57). This is supported by a detailed list of Defendant's own patent applications in which the ’814 patent was cited to the USPTO in an Information Disclosure Statement (Compl. ¶¶62-71).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: can the claims of the ’814 patent, which arise from a specification entirely focused on a two-part system with an external generator and an internal implant, be construed broadly enough to cover a fully external Transcranial Magnetic Stimulation (TMS) system? The case may turn on whether the absence of an explicit implant limitation in claim 1 is sufficient to overcome the patent's consistent disclosure of a two-part system.
- A key evidentiary and functional question will follow: if the claim scope is found to be broad enough, does the accused NeuroStar system, with its computer-based treatment protocols, embody the "limited number of predetermined programs" for simplified patient use as envisioned by the patent, or does its architecture represent a fundamentally different and more complex type of device than what was claimed?