DCT
2:25-cv-10036
UAB Pulsetto v. Electrocore Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: UAB Pulsetto (Lithuania)
- Defendant: electroCore, Inc. (Delaware)
- Plaintiff’s Counsel: Haug Partners LLP
- Case Identification: 2:25-cv-10036, D.N.J., 06/11/2025
- Venue Allegations: Venue is predicated on Defendant electroCore, Inc. having its principal place of business in Rockaway, New Jersey.
- Core Dispute: Plaintiff seeks a declaratory judgment that its Pulsetto® non-invasive neuromodulation device does not infringe Defendant's patent related to a stimulator for use with a mobile device.
- Technical Context: The technology concerns non-invasive vagus nerve stimulation (nVNS) devices, a therapeutic market in which the two parties are alleged to be direct competitors.
- Key Procedural History: This declaratory judgment action was filed in response to an Amazon Patent Evaluation Express (APEX) Notice initiated by Defendant electroCore. The APEX Notice alleged that Plaintiff's product infringed claim 27 of the patent-in-suit, which resulted in the product's removal from the Amazon platform. Filing a declaratory judgment action is one of the procedural options available to a seller under the APEX program to contest an infringement allegation and potentially keep its products listed for sale pending a court resolution.
Case Timeline
| Date | Event |
|---|---|
| 2013-01-15 | '491 Patent Priority Date |
| 2022-09-20 | '491 Patent Issue Date |
| 2025-05-22 | Defendant files Amazon APEX Notice |
| 2025-06-04 | Accused Product removed from Amazon (on or before this date) |
| 2025-06-11 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 11,446,491 - "Stimulator for use with a mobile device"
- Patent Identification: U.S. Patent No. 11,446,491, "Stimulator for use with a mobile device," issued September 20, 2022.
The Invention Explained
- Problem Addressed: The patent describes the challenges associated with existing electrical stimulation therapies, which often require surgically implanted devices. For non-invasive, self-administered therapies, it notes difficulties in ensuring the patient correctly positions the device and maintains the stimulation protocol without professional assistance (’491 Patent, col. 1:40-44; col. 5:56-65).
- The Patented Solution: The invention addresses these problems by proposing a system where a nerve stimulator is coupled to a mobile device, such as a smartphone. The mobile device runs a software application that can receive wireless signals and control the stimulator's operation, which in turn delivers electrical impulses through electrodes to a target nerve beneath the patient's skin (’491 Patent, Abstract; col. 7:45-54). This integration aims to leverage the processing power, user interface, and connectivity of a mobile phone to manage the therapy.
- Technical Importance: This approach makes non-invasive, self-administered nerve stimulation more accessible and controllable, allowing for complex therapy protocols to be managed through a common consumer device (’491 Patent, col. 3:9-22).
Key Claims at a Glance
- The complaint identifies independent claim 27, which was the subject of the underlying Amazon APEX Notice, and independent claim 1 as the two independent claims of the patent (’491 Patent, col. 51:1-52:45; Compl. ¶36).
- Independent Claim 27 recites the following essential elements:
- A system comprising: one or more electrodes configured for contacting an outer skin surface of a patient;
- a stimulator coupled to the one or more electrodes and configured for coupling to a mobile device configured to receive a wireless signal;
- and wherein the stimulator is configured to transmit an electrical impulse from the electrodes through the outer skin surface to a target site within a patient.
- The complaint seeks a declaration of non-infringement for all claims of the patent, thereby implicitly reserving the right to contest any dependent claims as well (Compl. ¶35).
III. The Accused Instrumentality
Product Identification
The Pulsetto® device, identified as the "Accused Product" (Compl. ¶¶14-15).
Functionality and Market Context
- The complaint describes the product as a "non-invasive neuromodulation product designed to support, inter alia, stress reduction, sleep, and focus" (Compl. ¶14).
- The product is sold throughout the United States, including via Amazon.com, which is alleged to be a "source of significant sales" (Compl. ¶¶15, 29).
- The complaint asserts that Plaintiff and Defendant are competitors in the "non-invasive vagus nerve stimulation market" (Compl. ¶7).
- No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
As this is a declaratory judgment action, the analysis focuses on the Plaintiff's asserted bases for non-infringement.
Claim Chart Summary
| Claim Element (from Independent Claim 27) | Plaintiff's Non-Infringement Position | Complaint Citation | Patent Citation |
|---|---|---|---|
| one or more electrodes configured for contacting an outer skin surface of a patient; | The complaint does not contest this element, describing the Accused Product as a "non-invasive neuromodulation product." | ¶14 | col. 21:7-13 |
| a stimulator coupled to the one or more electrodes and configured for coupling to a mobile device configured to receive a wireless signal; | Plaintiff asserts that the Accused Product does not include a stimulator with this configuration. | ¶39 | col. 7:27-34 |
| and wherein the stimulator is configured to transmit an electrical impulse from the electrodes through the outer skin surface to a target site within a patient. | Plaintiff's denial of this element is tied to its assertion that the Accused Product lacks the specific "stimulator" recited in the preceding limitation. | ¶39 | col. 7:35-41 |
Identified Points of Contention
- Scope Questions: The complaint’s denial of infringement focuses squarely on the "stimulator" limitation. This raises the question of how broadly the term "configured for coupling to a mobile device" will be interpreted. The dispute will likely center on whether the architecture of the Pulsetto® device, particularly its relationship with any associated mobile application, falls within the scope of this claim language.
- Technical Questions: The complaint provides no technical details about how the Pulsetto® device operates. A central question for the court will be what evidence demonstrates the actual functionality of the device. Does it operate entirely standalone, or does it have a wireless connection to a mobile device for functions that could be construed as "coupling" under the patent's claims?
V. Key Claim Terms for Construction
- The Term: "a stimulator... configured for coupling to a mobile device configured to receive a wireless signal"
- Context and Importance: This limitation is the explicit basis for Plaintiff's non-infringement argument (Compl. ¶39). The construction of this phrase is therefore central to the dispute. Practitioners may focus on this term because its interpretation will determine whether the Accused Product's architecture, which is not detailed in the complaint, can be found to infringe.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim language itself does not specify the purpose or type of coupling. The specification discloses general wireless communication, such as Bluetooth, which could support an argument that any functional wireless link for data exchange meets the "coupling" requirement (’491 Patent, col. 29:25-33).
- Evidence for a Narrower Interpretation: The patent’s detailed description and figures consistently portray the mobile device as an integral part of controlling the stimulation therapy itself, for example, by running a software application that generates and transmits the stimulation waveform to the electrodes (’491 Patent, col. 7:45-54; FIG. 3A). This could support a narrower construction where "coupling" requires a direct, functional link for controlling the core therapeutic output, not merely for ancillary functions like data logging or user support.
VI. Other Allegations
- Indirect Infringement: The complaint makes a blanket denial of infringing "either directly or indirectly" but offers no specific facts or arguments related to theories of induced or contributory infringement (Compl. ¶38).
- Willful Infringement: As a declaratory judgment action filed by the accused infringer, the complaint does not contain allegations of willfulness. However, the complaint establishes that Defendant electroCore put Plaintiff on notice of the patent via the Amazon APEX Notice on May 22, 2025 (Compl. ¶19). This pre-suit knowledge would be a foundational fact for any subsequent counterclaim for willful infringement brought by Defendant.
VII. Analyst’s Conclusion: Key Questions for the Case
This case appears poised to turn on the resolution of two primary questions:
- A core issue will be one of definitional scope: Will the court construe the phrase "a stimulator... configured for coupling to a mobile device," which is central to the asserted claim, to require deep functional integration for therapeutic control as suggested by the patent's embodiments, or will any form of wireless data link between the device and a mobile phone suffice?
- A key evidentiary question will be one of technical reality: The complaint offers only a conclusory denial of infringement. Discovery will be critical to establish the actual architecture and operational characteristics of the Pulsetto® device and determine whether its features meet the limitations of the patent's claims as they are ultimately construed by the court.