2:25-cv-04444
Biotraceit Corp v. Dullen
I. Executive Summary and Procedural Information
Parties & Counsel:
- Plaintiff: BioTraceIT Corporation (New York)
- Defendant: Deborah Dullen (United States / Canada) and Los Dud, Inc. (Pennsylvania)
- Plaintiff’s Counsel: Axenfeld Law Group, LLC
Case Identification: 2:25-cv-04444, E.D. Pa., 09/05/2025
Venue Allegations: Plaintiff alleges venue is proper in the Eastern District of Pennsylvania because a substantial part of the events giving rise to the claims occurred in the district, including Defendant Dullen's business activities from a Philadelphia-based office, the formation of Defendant Los Dud, Inc. as a Pennsylvania corporation, and patent-related filings directed from Pennsylvania.
Core Dispute: Plaintiff seeks a declaratory judgment that it is the rightful owner of patents related to medical pain-monitoring technology, alleging the patents were misappropriated by its former President through fraudulent assignments and other misconduct.
Technical Context: The technology relates to systems and methods for objectively quantifying a patient's pain by measuring autonomic nervous system activity, aiming to supplement or replace subjective patient-reported pain scales.
Key Procedural History: The complaint alleges a multi-year scheme by the defendant, a former president, to transfer ownership of company-developed intellectual property to herself and a shell corporation. Central allegations include the execution of an unauthorized patent assignment in 2015, the procurement of an "Inventorship Removal Acknowledgement" in 2016 through alleged misrepresentation, and an attempt to grant herself ownership of all company IP via a 2019 employment agreement. The plaintiff asserts these actions are void and that it has taken corrective measures, including filing a corrective assignment in 2025.
Case Timeline
| Date | Event |
|---|---|
| 2006-06-06 | Plaintiff's predecessor, Biographs LLC, is formed. |
| 2014-05-01 | Defendant Dullen executes an employment agreement with Biographs LLC. |
| 2015-01-10 | Earliest Priority Date for '877, '438, and '203 Patents (Provisional Application filing). |
| 2015-01-26 | Defendant Los Dud, Inc. is formed. |
| 2015-03-12 | Dullen allegedly executes an unauthorized assignment of the patent application to Los Dud, Inc. |
| 2016-01-10 | Non-provisional application leading to the '203 Patent is filed. |
| 2016-01-10 | Dullen allegedly procures an "Inventorship Removal Acknowledgement" from co-inventor Shore. |
| 2017-05-16 | A Los Dud Shareholders' Agreement is signed. |
| 2019-08-13 | U.S. Patent No. 10,376,203 is issued. |
| 2022-11-15 | U.S. Patent No. 11,497,438 is issued. |
| 2023-05-23 | U.S. Patent No. 11,653,877 is issued. |
| 2025-02-10 | BioTraceIT terminates Dullen's employment. |
| 2025-06-20 | BioTraceIT founder Shore executes a corrective "Assignment of Invention" reaffirming company ownership. |
| 2025-09-05 | First Amended Complaint is filed. |
II. Technology and Patent(s)-in-Suit Analysis
No probative visual evidence provided in complaint.
U.S. Patent No. 11,653,877 - "Method and Apparatus for the Measurement of Autonomic Function for the Diagnosis and Validation of Patient Treatments and Outcomes"
The Invention Explained
- Problem Addressed: The patent documentation describes the lack of a valid and reliable method for objectively quantifying an individual's pain, noting that clinicians typically rely on subjective and often inaccurate patient self-reporting (e.g., numerical rating scales) ('203 Patent, col. 1:30-44).
- The Patented Solution: The invention is a pain measurement and diagnostic system (PMD) that objectively measures "pain matrix" activity by analyzing the autonomic nervous system. This is accomplished by using medical devices with sensors placed on a patient to detect biosignals, which are then integrated with biological, psychological, and social factors to improve the diagnosis and evaluation of pain, disease states, and treatment options ('203 Patent, Abstract; '203 Patent, col. 2:15-29). The complaint states that the patents-in-suit share substantially identical disclosures (Compl. ¶ 26).
- Technical Importance: The technology purports to provide an objective, biophysical data point for pain, a historically subjective experience, potentially aiding in more accurate diagnoses, treatment validation, and management of pain medications ('203 Patent, col. 4:5-16).
Key Claims at a Glance
The complaint asserts ownership over the entire patent portfolio and does not allege infringement of specific claims (Compl. ¶¶ 5, 77-79). To illustrate the technology's patented scope, representative independent Claim 1 of the related '203 Patent is summarized below.
- A bioanalytical analysis system comprising:
- A device for measuring pain matrix activity with a sensor set configured for contralateral placement and at least one sensor for ipsilateral placement.
- The device is configured to measure voltage or current differentials from the contralateral sensors to detect a pain matrix response, and to measure impedance or other electrical properties from the ipsilateral sensor to calibrate the contralateral signal.
- A controller to collect and derive pain matrix activity data.
- A non-transitory computer-readable medium with instructions to access the pain data and "BioTrace Factors" (biophysical, demographic, etc.), identify a population with similar factors, and correlate treatments and outcomes to the pain data to determine treatment effectiveness.
U.S. Patent No. 11,497,438 - "Method and Apparatus for the Measurement of Autonomic Function for the Diagnosis and Validation of Patient Treatments and Outcomes"
The Invention Explained
- Problem Addressed: As with the related patents, the '438 Patent addresses the challenge of objectively measuring pain, which has historically relied on subjective patient reporting that can be inconsistent and difficult to verify ('203 Patent, col. 1:30-44; Compl. ¶ 26).
- The Patented Solution: The '438 Patent describes an autonomic function monitoring device that includes sensors for measuring pain matrix activity and, distinctly, a pressure measurement device. The system uses the pressure measurement to ensure that contralaterally placed sensors are applied with equal pressure against a patient's skin, thereby improving the reliability of the resulting biosignal measurements used to quantify pain ('438 Patent, Claim 1).
- Technical Importance: By incorporating a pressure measurement component, this aspect of the invention aims to standardize the physical application of the sensors, potentially reducing signal variability and improving the consistency and accuracy of objective pain measurements across different sessions and patients ('438 Patent, Claim 1).
Key Claims at a Glance
The complaint asserts ownership over the entire patent and does not allege infringement of specific claims (Compl. ¶¶ 5, 77-79). To illustrate the technology's patented scope, independent Claim 1 is summarized below.
- An autonomic function monitoring device comprising:
- A pain matrix activity measurement device with a plurality of sensors, including a pressure measurement device configured to measure the pressure of a sensor against the skin.
- A data acquisition system with a computer-readable medium.
- The medium includes instructions to access pressure data and display an indicator to allow a user to adjust for equal pressure across the sensors.
- The medium further includes instructions to access data from the plurality of sensors and identify deflections in that data as quantitative measurements of pain matrix activity.
U.S. Patent No. 10,376,203 - "Method and Apparatus for the Measurement of Autonomic Function for the Diagnosis and Validation of Patient Treatments and Outcomes"
The Invention Explained
- Technology Synopsis: This patent describes a bioanalytical system for diagnosing pain and measuring treatment effectiveness. It addresses the problem of subjective pain reporting by using a device with contralateral and ipsilateral biosensors to objectively measure "pain matrix" activity, and then correlates this data with a plurality of "BioTrace Factors" (e.g., biophysical, demographic, social factors) to create a more holistic and reliable assessment of a patient's condition ('203 Patent, Abstract; '203 Patent, col. 5:10-26).
Key Claims at a Glance
- Asserted Claims: The complaint seeks a declaratory judgment of ownership over the entire patent, not specific claims (Compl. ¶¶ 5(a), 77-86). Claim 1 is the lead independent claim.
- Accused Features: The complaint does not allege infringement of this patent against any product features; rather, it seeks a declaratory judgment of ownership over the patent itself (Compl. ¶¶ 5(a), 77-86).
III. Other Allegations
Declaratory Judgment of Patent Ownership: The primary patent-related cause of action seeks a declaration that BioTraceIT is the sole owner of the patents-in-suit (Compl. ¶¶ 77-86). Plaintiff’s ownership theory is based on the hired-to-invent doctrine and express contractual obligations requiring Defendant Dullen to disclose inventions and grant the company "all benefits" of her work (Compl. ¶¶ 19, 79). The complaint alleges that a 2015 assignment of the foundational patent application to Defendant Los Dud, Inc. is void ab initio for reasons including that it was an assignment of a company-owned invention, lacked corporate authorization and consideration, and was part of a fraudulent scheme (Compl. ¶ 80).
Breach of Fiduciary Duty: The complaint alleges that Defendant Dullen, as a director and officer, breached fiduciary duties of loyalty and candor to BioTraceIT and its shareholders (Compl. ¶¶ 87-95). The alleged breaches include claiming personal ownership of the company's intellectual property, orchestrating fraudulent assignments, and concealing these actions from the Board and investors (Compl. ¶¶ 89-90).
Trade Secret Misappropriation: Plaintiff alleges that Defendant Dullen misappropriated trade secrets in violation of the Defend Trade Secrets Act (Compl. ¶¶ 107-112). The alleged acts include downloading over 26 GB of confidential information, including technical specifications and business plans, and systematically emailing company documents to a personal email account to create a repository for a competing venture (Compl. ¶¶ 62-63, 109).
IV. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of rightful ownership: does the intellectual property at issue vest in BioTraceIT under the hired-to-invent doctrine and the terms of Defendant Dullen's employment agreements, or did subsequent assignments and inventorship acknowledgements validly transfer ownership to the Defendants?
- A key legal question will concern the validity of corporate acts: were the 2015 patent assignment to Los Dud, Inc. and the 2016 Inventorship Removal Acknowledgement void from the outset due to the complaint's allegations of misrepresentation, lack of corporate authority, and breach of fiduciary duty?
- A foundational factual dispute may be the determination of inventive contribution: what evidence exists to support the initial naming of Leonard Shore as a co-inventor on the provisional application, and what was the basis for his subsequent removal, which the complaint alleges was procured through misrepresentation?