DCT
3:25-cv-04866
DiLorenzo Biomedical LLC v. NeuroPace Inc
I. Executive Summary and Procedural Information
- Case Name: DiLorenzo Biomedical, LLC v. NeuroPace, Inc.
- Parties & Counsel:
- Plaintiff: DiLorenzo Biomedical, LLC (Washington)
- Defendant: NeuroPace, Inc. (California)
- Plaintiff’s Counsel: Liston Abramson LLP; Cypress LLP
- Case Identification: 3:25-cv-04866, N.D. Cal., 06/09/2025
- Venue Allegations: Venue is alleged to be proper based on Defendant having one or more regular and established places of business within the Northern District of California and having committed acts of infringement in the district.
- Core Dispute: Plaintiff alleges that Defendant’s RNS® System, an implantable neurostimulation device for treating epilepsy, infringes patents related to closed-loop neural sensing and modulation.
- Technical Context: The technology resides in the field of active implantable medical devices that monitor brain activity and deliver electrical stimulation to treat neurological disorders.
- Key Procedural History: The complaint notes that U.S. Patent No. 7,209,787 expired on December 28, 2019, limiting infringement claims for this patent to past damages.
Case Timeline
| Date | Event |
|---|---|
| 1998-08-05 | Earliest Priority Date for ’787 and ’880 Patents |
| 2007-04-24 | U.S. Patent No. 7,209,787 Issues |
| 2016-05-24 | U.S. Patent No. 9,345,880 Issues |
| 2019-12-28 | U.S. Patent No. 7,209,787 Expires |
| 2025-06-09 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 7,209,787 - "Apparatus and Method for Closed-Loop Intracranial Stimulation for Optimal Control of Neurological Disease" (Issued Apr. 24, 2007)
The Invention Explained
- Problem Addressed: The patent describes conventional neurostimulation treatments as being limited by their lack of responsiveness to a patient's changing neurological condition. Such systems required a pre-set stimulus or manual reprogramming, which could result in periods of over- or under-treatment (Compl. ¶13; ’787 Patent, col. 2:36-52).
- The Patented Solution: The invention is a "closed-loop" neurological control system that uses implanted sensors to monitor a patient's neural signals for characteristics indicative of a neurological condition. This sensory feedback is then used to automatically determine and deliver an appropriate neural modulation signal, creating a system that adapts therapy in response to the patient's real-time state (’787 Patent, Abstract; col. 4:8-21).
- Technical Importance: This approach allows for a dynamic therapy that can be tailored to a patient's specific needs, in contrast to static, open-loop stimulation methods (Compl. ¶1, 13).
Key Claims at a Glance
- The complaint asserts at least independent claim 1 (Compl. ¶17).
- The essential elements of Claim 1 are:
- At least one intracranial stimulating electrode arranged to deliver a neural modulation signal to a nervous system component.
- At least one sensor arranged to sense a parameter indicative or predictive of a seizure.
- A stimulating and recording unit arranged to generate the neural modulation signal based upon a neural response sensed by the sensor in response to a previously delivered neural modulation signal.
- The complaint does not explicitly assert dependent claims.
U.S. Patent No. 9,345,880 - "Closed-Loop Feedback-Driven Sympathetic Neuromodulation for Affect Control" (Issued May 24, 2016)
The Invention Explained
- Problem Addressed: The patent addresses the need for a system that can modulate a patient's "affect," or emotional state, by interfacing with the autonomic nervous system, specifically the sympathetic nervous system (’880 Patent, Abstract).
- The Patented Solution: The patent discloses a closed-loop system comprising a sensor array, signal conditioning and processing circuits, a control circuit, and a stimulating electrode array. The system is designed to estimate the neural state of a component of the sympathetic nervous system, which the patent defines as being "representative of affect," and then generate a signal to modulate that affect (’880 Patent, Abstract; Fig. 2).
- Technical Importance: This technology extends the closed-loop feedback concept to the specific domain of autonomic nervous system control for managing affective states, distinct from purely motor-control applications (’880 Patent, Abstract).
Key Claims at a Glance
- The complaint asserts at least independent claim 59 (Compl. ¶25).
- The essential elements of Claim 59 are:
- A sensor array.
- A signal conditioning circuit in communication with the sensor array.
- A signal processor configured to estimate the neural state of a component of the sympathetic nervous system, where the neural state is representative of affect.
- A control circuit configured to generate a signal to modulate affect.
- An output stage circuit in communication with the control circuit.
- A stimulating electrode array configured to interface with a component of the sympathetic nervous system.
- The complaint does not explicitly assert dependent claims.
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is the NeuroPace RNS® System, which includes RNS® Neurostimulator models RNS-300M and RNS-320, various Cortical Strip Lead models, and various Depth Lead models (Compl. ¶1, 10-14).
Functionality and Market Context
- The RNS® System is described as a "closed loop neural sensing and modulation" device that applies electrical modulation within the brain to treat epilepsy (Compl. ¶5, 16). The system uses implanted leads that function as both sensors and stimulating electrodes (Compl. ¶18-19). These leads sense electrocorticographic (ECoG) signal patterns that are indicative of an impending seizure (Compl. ¶19). A processing unit then analyzes these signals and directs the delivery of "responsive electrical stimulation" through the same or other leads to reduce the effect of the seizure (Compl. ¶20, 29). The complaint provides a system block diagram from the user manual showing this sense-process-treat workflow (Compl. p. 7, Fig. 3).
IV. Analysis of Infringement Allegations
’787 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| at least one intracranial stimulating electrode, each constructed and arranged to deliver a neural modulation signal... | The Accused Systems include intracranial stimulating electrodes, such as the Cortical Strip and Depth Leads, designed to deliver electrical modulation to the brain (Compl. p. 5, Figs. 2, 20). | ¶18 | col. 7:15-18 |
| at least one sensor, each constructed and arranged to sense at least one parameter...which is indicative or predictive of a seizure... | The same lead electrodes function as sensors to detect ECoG signal patterns that are indicative or predictive of a seizure. | ¶19 | col. 4:15-18 |
| a stimulating and recording unit constructed and arranged to generate said neural modulation signal based upon a neural response...in response to a previously delivered neural modulation signal. | The system’s "Microprocessor" and "stimulation subsystem" are alleged to generate responsive electrical stimulation based on the neural signals sensed by the lead electrodes. | ¶20 | col. 4:18-21 |
’880 Patent Infringement Allegations
| Claim Element (from Independent Claim 59) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a sensor array | The lead electrodes of the Accused Systems are alleged to constitute a sensor array. | ¶26 | col. 11:59-63 |
| a signal conditioning circuit... | The "sensing front end" of the Accused Systems allegedly performs signal conditioning. | ¶27 | col. 14:5-10 |
| a signal processor, configured to estimate the neural state of a component of the sympathetic nervous system... | The "Digital Processing and Analysis" block in the Accused Systems allegedly estimates a neural state indicative of seizure onset, which the complaint equates with a state of a component of the sympathetic nervous system. | ¶28 | col. 14:11-16 |
| a control circuit...configured to generate a signal to modulate affect | The "Microprocessor" block allegedly generates signals that reduce the effect of seizures, which the complaint alleges constitutes modulating affect. | ¶29 | col. 14:17-20 |
| an output stage circuit... | The "stimulation subsystem" of the Accused Systems allegedly functions as the output stage circuit. | ¶30 | col. 14:21-24 |
| a stimulating electrode array, configured to interface with a component of the sympathetic nervous system... | The lead electrodes allegedly interface with brain structures that comprise sympathetic nervous system components as understood in the context of the patent. | ¶31 | col. 14:25-29 |
- Identified Points of Contention:
- Scope Questions: A central issue for the ’880 Patent may be whether treating epileptic seizures falls within the claimed scope of modulating "affect" by interfacing with the "sympathetic nervous system." The complaint alleges that reducing the effect of a seizure is a form of modulating affect and that the targeted brain structures are components of the sympathetic nervous system as broadly defined in the patent (Compl. ¶29, 31; ’880 Patent, col. 4:34-38). This raises the question of whether the patent's language can be construed to cover epilepsy treatment, or if it is limited to conditions more traditionally associated with "affect," such as mood disorders.
- Technical Questions: For the ’787 Patent, a key factual question may be whether the accused RNS® System generates stimulation "based upon a neural response... in response to a previously delivered neural modulation signal." The analysis may focus on whether the system's feedback loop is simply reactive to seizure precursors, or if it truly senses and adapts based on the brain's specific response to its own therapeutic stimulation, as the claim language requires.
V. Key Claim Terms for Construction
Term: "neural response sensed... in response to a previously delivered neural modulation signal" (’787 Patent, Claim 1)
Context and Importance: This term defines the specific nature of the closed-loop feedback required by the claim. Infringement will depend on whether the accused system's operational cycle meets this "call and response" structure, where the system analyzes the effect of its own prior therapy to guide subsequent therapy.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent's abstract states that treatment parameters "may be derived from a neural response to previously delivered neural modulation signals," which could be interpreted to cover any system that stimulates, continues to sense the resulting brain state, and uses that ongoing sensing to inform future stimulation (’787 Patent, Abstract).
- Evidence for a Narrower Interpretation: The phrase "in response to" could be construed to require a direct, causal link where the system is programmed to specifically measure the immediate neurological effect of a given stimulation pulse or burst to determine the parameters of the next one, rather than just monitoring the general brain state over time.
Term: "affect" and "component of the sympathetic nervous system" (’880 Patent, Claim 59)
Context and Importance: The applicability of the ’880 patent to an epilepsy treatment device hinges on the scope of these terms. The plaintiff’s infringement theory requires construing "affect" to include the neurological state preceding a seizure and the "sympathetic nervous system" to include the brain regions targeted by the accused device.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The complaint points to language in the patent specification that defines the "sympathetic nervous system" very broadly to include "portions of the cerebral cortex, the hypothalamus, the brainstem, and the spinal cord" (’880 Patent, col. 4:34-38), which may encompass the brain regions targeted for epilepsy treatment. The patent may similarly contain language defining "affect" beyond its common meaning of mood or emotion.
- Evidence for a Narrower Interpretation: The ordinary meaning of "affect" typically relates to mood and emotion. The patent's title, "Affect Control," and potential examples in the specification related to psychiatric conditions could be used to argue for a narrower construction that excludes the electrophysiological events of an epileptic seizure.
VI. Other Allegations
- Indirect Infringement: The complaint does not plead separate counts for induced or contributory infringement. It focuses on allegations of direct infringement under 35 U.S.C. § 271(a) (Compl. ¶16, 24).
- Willful Infringement: The complaint does not contain explicit allegations of willful infringement or plead facts related to pre-suit knowledge of the patents. The prayer for relief includes a request for attorneys' fees and other damages pursuant to 35 U.S.C. §§ 284 or 285, which may be awarded in exceptional cases (Compl. p. 10, ¶3).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: can the terms "affect" and "sympathetic nervous system," central to the ’880 patent's claims, be construed to cover the treatment of epileptic seizures and the corresponding brain regions targeted by the accused RNS® System, or are they limited to psychiatric and autonomic functions?
- A key evidentiary question will be one of functional operation: does the accused RNS® System’s feedback mechanism operate by sensing a neural state that is a specific "response to a previously delivered" stimulation, as required by Claim 1 of the ’787 patent, or does it function as a simpler reactive system that detects a seizure precursor and then delivers a pre-set therapy?