DCT
4:23-cv-01800
DiLorenzo Biomedical LLC v. LivaNova Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: DiLorenzo Biomedical, LLC (Washington)
- Defendant: LivaNova, Inc. (California) and LivaNova USA, Inc. (Delaware)
- Plaintiff’s Counsel: Jackson Walker LLP
- Case Identification: 4:23-cv-01800, S.D. Tex., 05/17/2023
- Venue Allegations: Plaintiff alleges venue is proper in the Southern District of Texas because Defendants maintain regular and established places of business in the district and have committed the alleged acts of infringement, including offering for sale and selling the Accused Products, within the district.
- Core Dispute: Plaintiff alleges that Defendant’s VNS Therapy™ systems, which provide neurostimulation to treat epilepsy, infringe patents related to closed-loop neural modulation systems that adjust stimulation based on sensor feedback.
- Technical Context: The technology concerns implantable medical devices that automatically adapt therapeutic electrical stimulation in response to real-time physiological signals, aiming to improve treatment efficacy for neurological disorders.
- Key Procedural History: The complaint outlines a complex chain of title for two of the patents-in-suit. The inventor assigned the patents to BioNeuronics Corporation, and Defendants are alleged to be the successors-in-interest to BioNeuronics. However, Plaintiff alleges it was granted an exclusive license to the patents within a specific "Exclusive Field of Use," which it contends covers the accused activity, thereby granting it standing to sue for infringement.
Case Timeline
| Date | Event |
|---|---|
| 1998-08-05 | Earliest Priority Date for ’813, ’787, and ’880 Patents |
| 2002-04-02 | U.S. Patent No. 6,366,813 Issued |
| 2005-05-23 | Exclusive License Granted to Plaintiff's Predecessor |
| 2007-04-24 | U.S. Patent No. 7,209,787 Issued |
| 2016-05-24 | U.S. Patent No. 9,345,880 Issued |
| 2023-05-17 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 6,366,813 - "Apparatus and Method for Closed-Loop Intracranical Stimulation for Optimal Control of Neurological Disease"
The Invention Explained
- Problem Addressed: The patent’s background section describes prior art treatments for neurological disorders, such as drug therapy and constant-amplitude electrical stimulation, as being limited by their inability to respond to changes in a patient's condition or treatment needs over time (’813 Patent, col. 2:39-43).
- The Patented Solution: The invention is a "closed-loop" neurological control system that uses one or more sensors to monitor a patient's condition, processes those sensor signals to determine a "disease state," and automatically adjusts stimulation parameters based on that feedback (’813 Patent, col. 3:36-52; Fig. 2). This allows the therapy to be modulated in response to the patient's real-time needs.
- Technical Importance: This approach represented a shift from static, pre-programmed neurostimulation to a dynamic, adaptive therapy that could automatically optimize treatment magnitude (’813 Patent, col. 4:44-55).
Key Claims at a Glance
- The complaint asserts independent claim 1 (Compl. ¶25).
- The essential elements of claim 1 are:
- a signal conditioning circuit;
- a sensor array in electronic communication with the signal conditioning circuit;
- a signal processor in electronic communication with the signal conditioning circuit that performs disease state estimation;
- a control circuit in electronic communication with the signal processor;
- an output stage circuit in electronic communication with the control circuit; and
- a stimulating electrode array in electronic communication with the output stage circuit.
U.S. Patent No. 7,209,787 - "Apparatus and Method for Closed-Loop Intracranial Stimulation for Optimal Control of Neurological Disease"
The Invention Explained
- Problem Addressed: As a continuation-in-part of the application leading to the ’813 Patent, this patent addresses the same problem: conventional neurostimulation therapies are not responsive to fluctuations in patient symptomatology (’787 Patent, col. 2:40-42).
- The Patented Solution: The invention is a control system that delivers neural modulation, senses the patient's neural response to that modulation, and then uses that sensed response as feedback to modulate parameters for a subsequent neural modulation signal (’787 Patent, Abstract). This creates a feedback loop where the therapy is adjusted based on its observed effect.
- Technical Importance: This method provides a closed-loop system where the therapeutic output is dynamically controlled based on its measured effect on the patient, rather than on a pre-set program (’787 Patent, col. 4:54-61).
Key Claims at a Glance
- The complaint asserts independent claim 7, a means-plus-function claim (Compl. ¶36).
- The essential elements of claim 7 are:
- means for monitoring at least one parameter that is indicative or predictive of a seizure;
- means for delivering neural modulation signals to a nervous system component when the monitoring indicates seizure onset;
- means for sensing a neural response to the delivered signals; and
- controller means for modulating a parameter of a subsequent signal based on the sensed neural response to a previously delivered signal.
U.S. Patent No. 9,345,880 - "Closed-Loop Feedback-Driven Sympathetic Neuromodulation for Affect Control"
- Patent Identification: U.S. Patent No. 9,345,880, "Closed-Loop Feedback-Driven Sympathetic Neuromodulation for Affect Control," issued May 24, 2016.
- Technology Synopsis: The ’880 Patent describes a system for controlling affect (e.g., mood or emotional state) by modulating the sympathetic nervous system. It comprises a sensing module to detect an input related to affect, a processor that calculates a "neural state," and a control module that generates a modulating signal in response (’880 Patent, Abstract). The complaint alleges that treating epileptic seizures, which impact the sympathetic nervous system, falls within the scope of controlling affect (Compl. ¶22, ¶48).
- Asserted Claims: At least independent claim 56 is asserted (Compl. ¶45).
- Accused Features: The complaint accuses the VNS Therapy™ systems' functionality of monitoring heart rate to detect seizure onset and stimulating the vagus nerve in response. This is alleged to be a form of modulating the sympathetic nervous system to control affect by reducing the effects of seizures (Compl. ¶46-48).
III. The Accused Instrumentality
Product Identification
- LivaNova Aspire SR™ (Model 106), SenTiva™ (Model 1000), and SenTiva Duo™ (Model 1000-D) VNS Therapy™ systems ("Accused Products") (Compl. ¶2).
Functionality and Market Context
- The Accused Products are implantable neurostimulation devices designed to treat drug-resistant epilepsy (Compl. ¶21). They operate by applying "neural modulation to the vagus nerve" (Compl. ¶25). The complaint alleges these devices incorporate "closed-loop" features, where they monitor a patient's heart rate via lead electrodes and, upon detecting a relative increase indicative of a seizure, automatically deliver therapeutic stimulation (Compl. ¶2, ¶28, ¶38). The complaint references a diagram from the product's physician's manual, "Fig. 6 of Exhibit D," to identify an "Input/Output" block for signal amplification and a "Logic and Control" block for processing and control (Compl. ¶26, ¶28). The complaint alleges this closed-loop capability provides a "significant advantage in the field of nerve stimulation therapy" (Compl. ¶21).
IV. Analysis of Infringement Allegations
U.S. Patent No. 6,366,813 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| (A) a signal conditioning circuit | The "Input/Output" block, which provides "amplification of cardiac signals." | ¶26 | col. 14:1-4 |
| (B) a sensor array in electronic communication with said signal conditioning circuit | "lead electrodes" that sense cardiac signals. | ¶27 | col. 14:5-8 |
| (C) a signal processor in electronic communication with said signal conditioning circuit, wherein said signal processor performs disease state estimation | The "Logic and Control" block, which performs "Heartbeat Detection by detecting the R-wave of the ECG morphology." | ¶28 | col. 15:53-54 |
| (D) a control circuit in electronic communication with said signal processor | A circuit within the "Logic and Control" block. | ¶29 | col. 15:56-58 |
| (E) an output stage circuit in electronic communication with said control circuit | A circuit reflected in the "Input/Output" block. | ¶30 | col. 17:15-17 |
| (F) a stimulating electrode array, in electronic communication with said output stage circuit | The "lead electrodes" used to deliver stimulation. An image of these electrodes is referenced as "Fig. 7 of Exhibit D" (Compl. ¶31). | ¶31 | col. 17:26-28 |
U.S. Patent No. 7,209,787 Infringement Allegations
| Claim Element (from Independent Claim 7) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| means for monitoring at least one parameter that is indicative or predictive of a seizure | The system's components, including the "Logic and Control" block and leads, which monitor heart rate by detecting R-waves. | ¶37 | col. 4:10-14 |
| means for delivering neural modulation signals to at least one nervous system component when said means for monitoring indicates or predicts the onset of the seizure | The system's components delivering vagus nerve stimulation in response to a relative increase in the patient's heart rate. | ¶38 | col. 4:15-19 |
| means for sensing a neural response to said neural modulation signals | The system's ability to continue monitoring R-wave signals through the leads after delivering stimulation to sense a change in heart rate. | ¶39 | col. 4:15-19 |
| controller means for modulating at least one parameter of a subsequent neural modulation signal based upon the sensed neural response... | The "Logic and Control" block, which allegedly modulates subsequent vagus nerve stimulation signals based on the heart rate response to a previously delivered signal. | ¶40 | col. 4:15-19 |
Identified Points of Contention
- Scope Questions: The infringement theory for the ’813 Patent raises the question of whether the accused product’s function of "Heartbeat Detection" meets the claim requirement of "disease state estimation." The patent specification describes disease state estimation as a potentially complex process involving the aggregation of multiple sensor inputs, which may create a dispute over the proper scope of the term (’813 Patent, Fig. 10).
- Technical Questions: For the ’787 Patent, a key technical question is whether the Accused Products' control logic performs the specific feedback function required by the means-plus-function claim. The analysis may focus on whether the system dynamically modulates subsequent signals based on the sensed response to prior stimulation, as claimed, or if it employs a more direct trigger-and-response mechanism without the claimed feedback element for modulation.
V. Key Claim Terms for Construction
- The Term: "disease state estimation" (from claim 1 of the ’813 Patent)
- Context and Importance: This term is central to the infringement analysis for the ’813 patent. The dispute may turn on whether the accused product's alleged function—detecting an elevated heart rate—is broad enough to constitute "estimation" of a "disease state" as contemplated by the patent. Practitioners may focus on this term because the patent describes potentially more complex estimation processes than what is alleged in the complaint.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent states that a "disease state may be represented as a single value," which could support an argument that a single metric derived from heart rate qualifies (’813 Patent, col. 4:51-52).
- Evidence for a Narrower Interpretation: The detailed description and figures illustrate a "Disease State Estimator Module Array" that processes and aggregates signals from multiple, distinct sensors (e.g., EMG, EEG, accelerometers) to produce an "Aggregate Disease State Estimate" (’813 Patent, Fig. 10; col. 22:9-52). This could support an argument that the term requires a more sophisticated analysis than monitoring a single physiological parameter.
- The Term: "controller means for modulating ... based upon the sensed neural response to a previously delivered neural modulation signal" (from claim 7 of the ’787 Patent)
- Context and Importance: As a means-plus-function limitation, the scope of this term is defined by the corresponding structure described in the specification and its equivalents. The dispute will likely focus on whether the accused product's "Logic and Control" block is structurally equivalent to the patent's disclosed control circuit and performs the identical function of creating a closed feedback loop.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent abstract broadly describes deriving treatment parameters "from a neural response to previously delivered neural modulation signals sensed by one or more sensors," which could be argued to cover any system that adjusts therapy based on a measured physiological effect (’813 Patent, Abstract).
- Evidence for a Narrower Interpretation: The corresponding structure disclosed in the specification is a detailed "Control Law Circuit Block" that includes multiple sophisticated controllers (proportional, adaptive, nonlinear, etc.) that adjust an output based on an error signal between a reference state and an estimated disease state (’813 Patent, Fig. 12; col. 37:58-62). This detailed disclosure could support a narrower construction limited to systems with similar complex, adaptive feedback control logic.
VI. Other Allegations
- Indirect Infringement: The complaint does not plead specific facts to support claims for induced or contributory infringement.
- Willful Infringement: The complaint does not contain allegations of willful infringement or facts related to pre-suit knowledge of the patents-in-suit.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: can the term "disease state estimation," which the patent specification illustrates via multi-sensor aggregation, be construed to cover the accused products’ function of detecting a rapid heart rate, a single physiological indicator of a potential seizure?
- A key evidentiary question will be one of functional equivalence: for the means-plus-function claims of the ’787 patent, does the accused product's control system perform the specific, iterative function required by the claim—modulating subsequent stimulation based on the sensed response to a prior signal—or is there a fundamental mismatch in its technical operation compared to the closed-loop feedback structure disclosed in the patent?
- A potential threshold legal question concerns standing to sue: given that Defendants are alleged successors-in-interest to the original patent owner, the court may first need to resolve whether Plaintiff's "exclusive license" in the specified field of use grants it the necessary rights to bring this infringement action for the '813 and '787 patents.