DCT
0:24-cv-04091
DiLorenzo Biomedical LLC v. Medtronic Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: DiLorenzo Biomedical, LLC (Washington)
- Defendant: Medtronic, Inc. (Minnesota)
- Plaintiff’s Counsel: Avantech Law, LLP; Liston Abramson LLP
- Case Identification: 0:24-cv-04091, D. Minn., 10/31/2024
- Venue Allegations: Venue is alleged to be proper in the District of Minnesota because Defendant Medtronic, Inc. is incorporated in the state.
- Core Dispute: Plaintiff alleges that Defendant’s spinal cord stimulation (SCS) products infringe patents related to closed-loop neural stimulation systems that automatically modulate therapy based on sensor feedback.
- Technical Context: The technology involves implantable medical devices that treat chronic pain by delivering electrical stimulation, with systems designed to adjust treatment parameters in real-time based on a patient's condition or activity.
- Key Procedural History: The complaint notes that both asserted patents expired prior to the filing of the lawsuit. This indicates that the primary remedy sought will be monetary damages for past infringement rather than an injunction against future sales.
Case Timeline
| Date | Event |
|---|---|
| 1998-08-05 | Earliest Priority Date for ’813 and ’597 Patents |
| 2002-04-02 | ’813 Patent Issued |
| 2014-07-15 | ’597 Patent Issued |
| 2019-06-25 | ’813 Patent Expired |
| 2022-02-23 | ’597 Patent Expired |
| 2024-10-31 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 6,366,813 - "Apparatus and Method for Closed-Loop Intracranial Stimulation for Optimal Control of Neurological Disease," Issued April 2, 2002
The Invention Explained
- Problem Addressed: Prior to the invention, electrical neurostimulation therapies required manual or periodic external adjustments, which could be difficult for patients and failed to respond to dynamic changes in a patient’s condition, leading to periods of over- or under-treatment (Compl. ¶11; ’813 Patent, col. 2:31-48).
- The Patented Solution: The patent describes a "closed-loop" neurological control system that uses a sensor array to detect signals indicative of a patient's "disease state." This sensory feedback is processed to automatically adjust the electrical stimulation delivered to the patient, thereby optimizing the therapy in real-time without manual intervention (’813 Patent, Abstract; Fig. 2; col. 4:5-19).
- Technical Importance: The invention's approach sought to automate the determination of an optimal treatment magnitude, making the therapy responsive to the patient's fluctuating needs and reducing reliance on clinician visits for adjustments (’813 Patent, col. 4:46-59).
Key Claims at a Glance
- The complaint asserts infringement of at least independent claim 1 (Compl. ¶15).
- 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, where the processor 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
- A stimulating electrode array in electronic communication with the output stage circuit
- The complaint does not explicitly reserve the right to assert dependent claims.
U.S. Patent No. 8,781,597 - "Systems for Monitoring a Patient's Neurological Disease State," Issued July 15, 2014
The Invention Explained
- Problem Addressed: The ’597 Patent addresses the same core problem as the ’813 Patent: conventional neurostimulation systems are not responsive to changes in a patient’s condition and require protracted, manual adjustments (’597 Patent, col. 2:35-52).
- The Patented Solution: This patent also describes a closed-loop system for modulating therapy based on sensor feedback that estimates a "neurological disease state." A key feature added in this patent is a "patient interface module" that is external to the patient's body and communicates information about the estimated disease state to the patient, facilitating monitoring by the patient or a healthcare provider (’597 Patent, Abstract; Fig. 2; col. 11:11-23).
- Technical Importance: The addition of an external interface module provides a means for patients and clinicians to monitor the performance of the automated therapy system and to potentially adjust control parameters without direct invasive access (’597 Patent, col. 12:44-56).
Key Claims at a Glance
- The complaint asserts infringement of at least independent claim 1 (Compl. ¶26).
- The essential elements of Claim 1 are:
- One or more sensors that sense a signal indicative of a neurological disease state
- A signal processing assembly that processes the signal to estimate the disease state and adjust a therapy parameter as a function of the estimate
- A treatment assembly that delivers the therapy to a nervous system component
- A patient interface module that communicates the estimated disease state, is in communication with the signal processing assembly, and is external to the patient's body
- The complaint does not explicitly reserve the right to assert dependent claims.
III. The Accused Instrumentality
Product Identification
- The Medtronic RestoreSensor™, Intellis™, and Vanta™ spinal cord stimulation products, along with related components such as external wireless telemetry and communication devices (Compl. ¶15, ¶26).
Functionality and Market Context
- The Accused Products are implantable systems that apply neural modulation to the spinal cord to treat chronic back pain (Compl. ¶15). The complaint alleges that these products incorporate sensors such as accelerometers and gyroscopes to detect a patient's posture (e.g., activity levels, velocity) (Compl. ¶17). This sensor data is allegedly processed to estimate a "disease state," which the complaint links to postural conditions indicative of chronic back pain, and the system then modulates the stimulation therapy based on this estimation (Compl. ¶18, ¶28, ¶29).
- The complaint provides a diagram from a Medtronic patent to illustrate the accused system architecture, showing a sensor, processor, therapy module, and electrodes (Compl. ¶16, FIG. 2). The systems also include external components, such as handheld units or tablets, that communicate wirelessly with the implanted device and provide a user interface (Compl. ¶26, ¶31). A Medtronic publication screenshot describes this as "AdaptiveStim™ technology" that "personalizes treatment based on your body signals" and can "automatically adjust" therapy based on body position (Compl. ¶29, p. 8).
IV. Analysis of Infringement Allegations
’813 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| (A) a signal conditioning circuit | The Accused Products comprise a signal conditioning circuit for conditioning signals input from sensors. | ¶16 | col. 14:1-4 |
| (B) a sensor array in electronic communication with said signal conditioning circuit | The Accused Products incorporate sensor arrays, including accelerometers and gyroscopes, that provide raw signals to the circuit. | ¶17 | col. 14:5-34 |
| (C) a signal processor...wherein said signal processor performs disease state estimation | The Accused Products include a signal processor that performs disease state estimation, for example by estimating patient posture based on sensor inputs. | ¶18 | col. 16:1-4 |
| (D) a control circuit in electronic communication with said signal processor | The Accused Products include a control circuit in electronic communication with the signal processor. | ¶19 | col. 16:14-16 |
| (E) an output stage circuit in electronic communication with said control circuit | The Accused Products comprise an output stage circuit in electronic communication with the control circuit. | ¶20 | col. 17:15-17 |
| (F) a stimulating electrode array, in electronic communication with said output stage circuit | The Accused Products comprise a stimulating electrode array that communicates with the output stage circuit to deliver therapy. | ¶21 | col. 17:25-27 |
’597 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| one or more sensors that sense at least one signal that comprise a characteristic that is indicative of a neurological disease state | The Accused Products comprise sensors that sense signals indicative of a neurological disease state, such as postural conditions indicative of chronic back pain. | ¶28 | col. 14:8-11 |
| a signal processing assembly...that processes the at least one signal...to estimate the neurological disease state and to adjust a parameter of a therapy...as a function of the estimated neurological disease state | The Accused Products comprise a signal processing assembly that estimates the neurological disease state and adjusts a therapy parameter based on that estimate. A provided screenshot shows the system "will remember and automatically adjust" based on the patient's position. | ¶29 | col. 16:1-25 |
| a treatment assembly...wherein said treatment assembly delivers the therapy to a nervous system component of the patient | The Accused Products comprise a treatment assembly that delivers stimulation therapy to a nervous system component of the patient. | ¶30 | col. 17:15-27 |
| a patient interface module that communicates with a patient the estimated disease state...and external to the patient's body | The handheld units, tablets, and telemetry devices of the Accused Products comprise an external patient interface module that communicates with the implanted components. The complaint provides a photo showing an external tablet-like programmer communicating with the implanted device. | ¶31 | col. 11:11-23 |
- Identified Points of Contention:
- Scope Questions: A primary question may be whether adjusting therapy based on a patient's physical posture, as detected by an accelerometer, constitutes performing "disease state estimation" as that term is used in the ’813 Patent. The dispute may center on whether the patent's definition can be read on detecting general physical orientation, or if it is limited to measuring more direct neurological or physiological signals (e.g., EMG, EEG) as described in the patent's specific embodiments.
- Technical Questions: For the ’597 Patent, a question may arise regarding whether Medtronic's external programmers and telemetry devices, which serve various system functions, meet all the limitations of the claimed "patient interface module," specifically the requirement that it "communicates with a patient the estimated disease state." The evidence required will need to show not just communication between the external and internal parts, but the specific communication of the "estimated disease state."
V. Key Claim Terms for Construction
The Term: "disease state estimation" (’813 Patent, Claim 1)
- Context and Importance: This term is the functional core of the closed-loop invention. Its construction will determine whether the accused functionality—adjusting stimulation based on detected posture—infringes. Practitioners may focus on this term because the complaint's theory equates posture with a "disease state," a connection that may be disputed.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent specification suggests "disease state" can be a broad concept, stating it may be a "quantitative representation of the level or 'state' of the disease" and can be "represented as a single value or a vector or matrix of values" (’813 Patent, col. 4:51-56). This could support an argument that a posture value qualifies.
- Evidence for a Narrower Interpretation: The detailed embodiments in the specification heavily focus on estimating disease state by processing specific biological signals like EMG (tremor), EEG, and neural spikes (’813 Patent, col. 23:30-40; Figs. 5, 6, 9). This may support an argument that "disease state estimation" requires more than just interpreting data from a mechanical sensor like an accelerometer.
The Term: "patient interface module" (’597 Patent, Claim 1)
- Context and Importance: This element is a key limitation of the asserted ’597 claim. The infringement analysis for this patent will depend on whether Medtronic's external programmers and communicators are properly characterized as this claimed module.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification describes the module as a device that can "remain external to the body of the patient" and facilitates functions like "monitoring of disease state" and "adjustment of control parameters" (’597 Patent, col. 11:13-19). This language appears to align with the functionality of the accused external programmers. The complaint includes a photograph showing an external tablet displaying therapy data, which supports this interpretation (Compl. ¶26, p. 6).
- Evidence for a Narrower Interpretation: An opposing argument might suggest that to qualify as the claimed module, a device must perform all functions listed in the specification's description, or that it must be primarily for patient use rather than clinician programming. However, the claim itself only requires that the module "communicates with a patient the estimated disease state," a potentially lower bar than the full suite of functions described in the detailed description.
VI. Other Allegations
The complaint does not contain explicit counts for indirect or willful infringement. The prayer for relief includes a standard request for attorneys' fees and other damages under 35 U.S.C. §§ 284 or 285, but no specific facts are alleged to support a claim of willfulness.
VII. Analyst’s Conclusion: Key Questions for the Case
With both patents having expired, this dispute centers exclusively on establishing liability for past infringement and calculating a reasonable royalty. The outcome will likely depend on the court's interpretation of two central issues:
- A core issue will be one of definitional scope: can the term "disease state estimation," which is described in the patent’s embodiments in the context of direct neurological signals like tremor, be construed to cover the estimation of posture-related pain based on data from accelerometers and gyroscopes?
- A key evidentiary question will be one of functional mapping: do Medtronic's external programmers and communication devices, which serve multiple functions, perform the specific role of a "patient interface module" that "communicates with a patient the estimated disease state," as required by Claim 1 of the ’597 patent?