DCT
0:25-cv-03643
Trackcore LLC v. Biomedical Synergies Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: TrackCore LLC (Delaware)
- Defendant: Biomedical Synergies, Inc. (Minnesota)
- Plaintiff’s Counsel: Paul, Weiss, Rifkind, Wharton & Garrison LLP; Stinson LLP
- Case Identification: 0:25-cv-03643, D. Minn., 09/12/2025
- Venue Allegations: Venue is based on Defendant BSI being a Minnesota corporation with its principal place of business in the District of Minnesota.
- Core Dispute: Plaintiff seeks declaratory judgments that its software does not infringe Defendant’s patents, and that the patents are invalid and unenforceable due to prosecution misconduct and failure to claim patentable subject matter.
- Technical Context: The dispute concerns software systems used by hospitals to track and manage human tissues and medical implants, a field with significant patient safety and regulatory compliance implications.
- Key Procedural History: The action was filed in response to cease-and-desist letters sent by Defendant (BSI) to Plaintiff (TrackCore) and its customers. The complaint alleges that during prosecution of the patents-in-suit, BSI failed to disclose material prior art, including competing commercial systems and established FDA and Joint Commission standards. The complaint also references a 2020 Patent Trial and Appeal Board decision in a related BSI application, which found claims of a similar scope invalid as directed to an abstract idea.
Case Timeline
| Date | Event |
|---|---|
| 2005-02-18 | Launch of competing SafeNET software alleged as prior art |
| 2005-05-20 | FDA issues Current Good Tissue Practice regulations |
| 2006-03-01 | Launch of competing GraftTracker® software alleged as prior art |
| 2006-07-10 | Launch of competing ImplantMotion software alleged as prior art |
| 2006-09-21 | Priority Date for ’762 and ’706 Patents (Provisional App. No. 60/826,492 filed) |
| 2006-11-01 | Plaintiff's TrackCore® Operating Room software first launched |
| 2014-03-04 | U.S. Patent No. 8,666,762 Issues |
| 2020-06-02 | U.S. Patent No. 10,671,706 Issues |
| 2020-07-22 | PTAB issues decision in related BSI patent application appeal |
| 2025-05-16 | BSI sends cease-and-desist letter to TrackCore |
| 2025-06-16 | TrackCore responds to BSI, asserting non-infringement and invalidity |
| 2025-08-28 | BSI reiterates demands to TrackCore and sends letters to TrackCore's customers |
| 2025-09-12 | Complaint for Declaratory Judgment filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,666,762 - "Tissue Management System"
The Invention Explained
- Problem Addressed: The patent describes safety problems and regulatory compliance failures in hospitals related to the handling of transplantable tissues, noting that hospitals often lack established procedures for receiving, storing, and tracking these critical materials, which can lead to adverse patient outcomes like infections (’762 Patent, col. 3:5-14; col. 4:58-67).
- The Patented Solution: The invention is a computer-based system that prompts and verifies that hospital staff handle transplantable materials in a safe and regulatory-compliant manner. It creates an integral record to trace the material from its receipt by the hospital to its implantation in a patient, with the software program being "built upon the standard operating procedures" of the medical establishment to ensure compliance (’762 Patent, Abstract; col. 5:58-61).
- Technical Importance: The technology purports to solve the problem of fragmented and unreliable paper-based or ad-hoc tracking methods by providing a comprehensive, auditable electronic record that enforces compliance with established safety protocols (’762 Patent, col. 7:1-9).
Key Claims at a Glance
- The complaint identifies independent claims 1 and 12 as asserted by BSI (Compl. ¶16, 36).
- Claim 1 (System):
- A tissue management system with a database, processor, and software program.
- The system contains organized instructions for tracking the internal processing of transplantable material.
- The system includes "means for assigning a unique identification code" to the material upon receipt.
- The system includes "means for prompting an inspection" of the material for an unsafe condition.
- The system includes "means for processing such entered data by the software program which is built upon the standard operating procedures adopted by the medical establishment."
- The system includes means for prompting patient assessment and investigating and reporting adverse reactions.
- Claim 12 (System):
- A tissue management system with a database, processor, and software program.
- The system contains organized instructions for tracing transplantable material throughout its internal life until implantation.
- The system includes means for documenting processing steps (e.g., login, handling, storage), the location of the material, the identity of staff, and the date/time of each step.
- The system includes "means for processing such entered data by the software program which is built upon the standard operating procedures" to ensure compliance before the next step can be undertaken.
- The complaint notes that the asserted claims consist almost entirely of means-plus-function elements (Compl. ¶16).
U.S. Patent No. 10,671,706 - "Tissue Management System"
The Invention Explained
- Problem Addressed: The patent addresses the same technical problem as its parent ’762 patent: the risk of infection, rejection, or other adverse patient outcomes due to improper handling, storage, or tracking of transplantable materials within a medical facility ('706 Patent, col. 2:64-col. 3:2).
- The Patented Solution: The invention is a computer-implemented tracing system that uses a plurality of graphical user interfaces (GUIs) to require staff members to document specific steps in the lifecycle of a transplantable material, such as login, handling, and storage conditions. The system is programmed to force staff to complete required data entry for one step before allowing them to proceed to the next, thereby creating a reliable electronic audit trail from supplier to patient ('706 Patent, Abstract; col. 8:8-17). The system's software incorporates a "comprehensive set of standard operating procedures adopted by the specific medical establishment" ('706 Patent, col. 29:56-59).
- Technical Importance: This technology aims to replace error-prone manual processes with a guided, software-enforced workflow, improving compliance with safety standards mandated by regulatory bodies like the FDA and JCAHO ('706 Patent, col. 4:58-67).
Key Claims at a Glance
- The complaint identifies independent claim 1 as asserted by BSI (Compl. ¶18, 36).
- Claim 1 (System):
- A computer-implemented tissue tracing management system for tracing a piece of transplantable material.
- The system includes a database, a central processing unit, and a memory unit incorporating a software program.
- The software program includes GUIs with fields and check boxes for data input by a staff member.
- The software program incorporates "a comprehensive set of standard operating procedures adopted by the specific medical establishment" for documenting the material's location and handling.
- The system is programmed to assign a unique identification code upon receipt, require data entry for each processing step, and trace the material back to the supplier or forward to the patient.
- The system is programmed to prevent a user from proceeding to a subsequent step if data for a prior required step has not been entered.
III. The Accused Instrumentality
Product Identification
TrackCore® Operating Room software (Compl. ¶34).
Functionality and Market Context
The complaint describes the accused product as "tissue and implant tracking software, which enables hospitals to enhance patient safety, streamline inventory management, and ensure compliance with stringent regulatory standards" (Compl. ¶2). The software is alleged to eliminate manual processes through features like "custom barcodes" for "automated and consistent data entry" (Compl. ¶3). The complaint states that TrackCore is a "leading provider" of such software to over 1,300 healthcare facilities nationwide (Compl. ¶4). No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
This is a declaratory judgment action where the Plaintiff, TrackCore, alleges its products do not infringe. The following chart summarizes TrackCore's stated basis for non-infringement.
’762 Patent Infringement Allegations
| Claim Element (from Independent Claims 1 and 12) | Alleged Non-Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| ...means for processing such entered data by the software program which is built upon the standard operating procedures [adopted by the medical establishment]... | The TrackCore software has its own operating procedures for processing tissues; it is not built upon and does not incorporate standard operating procedures adopted by the health care facility where it is installed. | ¶45 | col. 5:58-61 |
| ...a comprehensive set of standard operating procedures adopted by the medical establishment... | The TrackCore software is alleged to be a standalone product with its own pre-defined procedures, rather than a system built upon or customized to a specific hospital's existing procedures. | ¶45 | col. 5:48-51 |
’706 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Non-Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| ...software program incorporating a comprehensive set of standard operating procedures adopted by the specific medical establishment. | The TrackCore software has its own operating procedures for processing tissues; it is not built upon and does not incorporate the standard operating procedures adopted by the health care facility where it is installed. | ¶45 | col. 29:56-59 |
- Identified Points of Contention:
- Scope Questions: The central dispute appears to be definitional: does a software product that comes with its own standardized workflow satisfy a claim limitation requiring a program that is "built upon" or "incorporating" the pre-existing, "adopted" procedures of the specific hospital where it is installed? The case may turn on whether "incorporating" means the software must be customized to each hospital's unique procedures or if providing a comprehensive, compliant procedure set is sufficient.
- Technical Questions: A key factual question will be how the TrackCore software is implemented and operates in practice. Does it merely replace a hospital's procedures, or does it, in fact, ingest, codify, or otherwise "incorporate" the hospital's mandated workflows as part of its configuration and operation? The complaint's assertion that the software has its "own operating procedures" suggests a fundamental operational mismatch with the claim language (Compl. ¶45).
V. Key Claim Terms for Construction
The Term: "means for processing such entered data by the software program which is built upon the standard operating procedures adopted by the medical establishment" (’762 Patent, Claim 1).
Context and Importance: This is a means-plus-function limitation under 35 U.S.C. § 112(f). Its scope is not limitless but is confined to the specific algorithm or "structure" described in the patent's specification for performing the claimed function, and its equivalents. The complaint alleges the patent specifications "do not disclose how the claimed systems work or how, technologically or by algorithm, the various claimed functions and features are performed," raising the possibility of an indefiniteness challenge (Compl. ¶19).
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification describes the system in functional terms, stating it "will refuse to permit the staff members to enter data into the system for a critical processing step unless data from a previous critical processing step has already been entered" (’762 Patent, col. 7:65-col. 8:3). This functional description could be argued to cover any software that performs sequential step validation.
- Evidence for a Narrower Interpretation: The structure corresponding to this "means" appears to be a general-purpose computer and software, without disclosure of a specific algorithm ('762 Patent, Fig. 2; col. 10:46-51). An accused infringer may argue that because no specific algorithm is disclosed, the claim is indefinite for failing to disclose corresponding structure.
The Term: "built upon" / "incorporating" [a medical establishment's standard operating procedures] (’762 Patent, Claim 1; ’706 Patent, Claim 1).
Context and Importance: This phrase is the crux of TrackCore’s non-infringement argument (Compl. ¶45). The definition will determine whether an off-the-shelf software with its own best-practice workflow can infringe claims directed at a system that integrates a specific facility's existing procedures.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: BSI may argue that any software system that performs functions which are consistent with or required by a hospital's procedures is "built upon" or "incorporates" them, even if the software provides those procedures itself. The specification states the system is "tailored to the specific medical establishment and its handling and use of transplant materials" (’762 Patent, col. 9:18-20).
- Evidence for a Narrower Interpretation: TrackCore will likely argue that "built upon" and "incorporating" require the software to be actively configured using a hospital's pre-existing, written SOPs as a direct input or structural basis. The patent repeatedly refers to procedures "adopted by the medical establishment," suggesting the procedures exist independently of the patented software system (’762 Patent, col. 5:58-61).
VI. Other Allegations
- Indirect Infringement: TrackCore seeks a declaratory judgment that it has not actively induced or contributed to the infringement of any claim (Compl. ¶44). This preempts a potential claim from BSI, which could be based on BSI's allegation that TrackCore sells an infringing system to hospitals that then use it in an infringing manner. BSI's letters to TrackCore's customers also suggest an intent to pursue infringement claims against direct users (Compl. ¶40).
- Unenforceability / Inequitable Conduct: TrackCore makes detailed allegations supporting a declaratory judgment of unenforceability based on inequitable conduct (Compl. ¶¶ 51-54). The complaint alleges BSI and its inventors intentionally misled the USPTO by failing to disclose known, material prior art during prosecution, including: (1) competing commercial software systems like SafeNET and GraftTracker that were launched before the patents' priority date (Compl. ¶¶ 12, 23-24); and (2) rules and standards from the FDA and the Joint Commission that allegedly disclosed most of the claimed functions (Compl. ¶22).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of validity and enforceability: Can the patents survive substantive challenges based on allegations of inequitable conduct for failure to disclose material prior art? The complaint's detailed recitation of specific competing systems and regulatory standards known to the inventors during prosecution suggests this will be a central battleground (Compl. ¶¶ 22-24).
- A second key issue is one of definitional scope and non-infringement: Can the claim terms "built upon" and "incorporating" be construed to cover a software product that provides its own pre-packaged, standardized workflow, as TrackCore alleges its software does, rather than one that is customized based on a specific hospital's existing procedures? (Compl. ¶45).
- A third question will be one of claim construction under § 112: For the means-plus-function limitations in the ’762 patent, does the specification disclose adequate corresponding algorithms or structure to render the claims definite, or are they invalid for indefiniteness, as the complaint suggests? (Compl. ¶19).