DCT
2:14-cv-00654
MY Health Inc v. Cardiomedix Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: My Health, Inc. (Delaware)
- Defendant: Cardiomedix, Inc. (Illinois)
- Plaintiff’s Counsel: Capshaw Derieux, L.L.P.; Polasek, Quisenberry & Errington, L.L.P.; Pia Anderson Dorius Reynard & Moss, LLC; The Wolford Law Firm LLP
- Case Identification: 2:14-cv-00654, E.D. Tex., 06/02/2014
- Venue Allegations: Plaintiff alleges venue is proper because Defendant conducts business and has allegedly infringed within the district, and because an inventor of the patent-in-suit resides in the district.
- Core Dispute: Plaintiff alleges that Defendant’s remote patient monitoring services infringe a patent related to a method and system for monitoring and treating a patient.
- Technical Context: The technology concerns internet-based systems for managing chronic illnesses by collecting patient data, automatically assessing the patient's condition against guidelines, and updating a treatment plan.
- Key Procedural History: The patent-in-suit was assigned from the University of Rochester to Plaintiff My Health, Inc., which is alleged to provide Plaintiff with the right to sue for past and present infringement.
Case Timeline
| Date | Event |
|---|---|
| 2001-02-26 | '985 Patent Priority Date |
| 2003-09-02 | '985 Patent Issue Date |
| 2014-06-02 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 6,612,985 - Method and system for monitoring and treating a patient
Issued September 2, 2003.
The Invention Explained
- Problem Addressed: The patent identifies a challenge in medicine where patients with chronic illnesses like asthma often do not receive consistent, ongoing follow-up care in accordance with recommended guidelines, leading to preventable symptoms, hospitalizations, and deaths (’985 Patent, col. 1:12-32). Existing internet-based monitoring systems were noted as having limitations, such as failing to incorporate subjective data or customize treatment plans (’985 Patent, col. 2:5-8).
- The Patented Solution: The invention is a method and system for remote patient care where a central system receives both objective (e.g., from a medical device) and subjective (e.g., patient-reported symptoms) data from a remotely located patient. This data is used to determine a "current assessment" of the patient's condition based on pre-defined "assessment guidelines." The system then updates an "existing treatment plan" based on this new assessment and transmits the updated plan back to the patient for implementation (’985 Patent, Abstract; col. 2:15-32). The process is illustrated in flowcharts, such as FIG. 2, which shows the steps of obtaining data, and FIG. 4, which shows the logic for modifying a treatment plan.
- Technical Importance: This approach sought to automate and individualize chronic disease management, potentially improving patient compliance and health outcomes while reducing costs associated with emergency visits, by creating a dynamic feedback loop between patient status and treatment protocols (’985 Patent, col. 1:40-51; col. 4:21-30).
Key Claims at a Glance
- The complaint asserts independent claim 7 and dependent claims 1 and 4. Claim 7 is a computer-readable medium claim, whose patentability is tied to the underlying method. The core method steps are articulated in independent claim 1.
- Independent Claim 1 (Method Claim) Elements:
- determining a current assessment of one or more diagnosed conditions in a patient based on data about each of the diagnosed conditions from the patient who is at a remote location and on one or more assessment guidelines for each of the diagnosed conditions;
- updating an existing treatment plan for each of the diagnosed conditions based on the existing treatment plan, the current assessment, and on one or more treatment guidelines for each of the diagnosed conditions to generate an updated treatment plan for each of the diagnosed conditions;
- reviewing the updated treatment plan for each of the diagnosed conditions;
- determining if one or more changes are needed to the reviewed treatment plan for each of the diagnosed conditions;
- changing the reviewed treatment plan if the one or more changes are determined to be needed;
- providing the patient with the reviewed treatment for each of the diagnosed conditions; and
- generating and providing compliance data based on the updated treatment plan and the reviewed treatment plan for each of the diagnosed conditions.
- The complaint reserves the right to assert other claims (’985 Patent, col. 15:52-16:12; Compl. ¶22).
III. The Accused Instrumentality
Product Identification
- The "Telehealth/Cardiac Event Remote Monitoring Services" (the "Accused Product") offered by Cardiomedix, Inc. (Compl. ¶22).
Functionality and Market Context
- The complaint provides no specific technical details on the operation of the Accused Product. It is identified as a service for remote monitoring and is alleged to have generated "significant sales" (Compl. ¶10, ¶22). The allegations suggest the Accused Product is a system or method that Cardiomedix makes, uses, sells, or offers for sale (Compl. ¶22). No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint alleges infringement in a conclusory manner without mapping specific features of the Accused Product to claim elements. The following chart summarizes the allegations for the lead independent method claim by mapping the single, overarching description of the Accused Product to each claim element as implicitly alleged by the complaint.
'985 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| determining a current assessment of one or more diagnosed conditions in a patient based on data about each of the diagnosed conditions from the patient who is at a remote location and on one or more assessment guidelines... | The complaint alleges the Accused Product, identified as Telehealth/Cardiac Event Remote Monitoring Services, performs this step. | ¶22 | col. 15:55-59 |
| updating an existing treatment plan for each of the diagnosed conditions based on the existing treatment plan, the current assessment, and on one or more treatment guidelines...to generate an updated treatment plan... | The complaint alleges the Accused Product, identified as Telehealth/Cardiac Event Remote Monitoring Services, performs this step. | ¶22 | col. 16:1-5 |
| reviewing the updated treatment plan for each of the diagnosed conditions; | The complaint alleges the Accused Product, identified as Telehealth/Cardiac Event Remote Monitoring Services, performs this step. | ¶22 | col. 16:6-7 |
| determining if one or more changes are needed to the reviewed treatment plan...; | The complaint alleges the Accused Product, identified as Telehealth/Cardiac Event Remote Monitoring Services, performs this step. | ¶22 | col. 16:8-10 |
| changing the reviewed treatment plan if the one or more changes are determined to be needed; | The complaint alleges the Accused Product, identified as Telehealth/Cardiac Event Remote Monitoring Services, performs this step. | ¶22 | col. 16:11-12 |
| providing the patient with the reviewed treatment for each of the diagnosed conditions; and | The complaint alleges the Accused Product, identified as Telehealth/Cardiac Event Remote Monitoring Services, performs this step. | ¶22 | col. 16:13-14 |
| generating and providing compliance data based on the updated treatment plan and the reviewed treatment plan for each of the diagnosed conditions. | The complaint alleges the Accused Product, identified as Telehealth/Cardiac Event Remote Monitoring Services, performs this step. | ¶22 | col. 16:15-18 |
- Identified Points of Contention:
- Factual Questions: Given the lack of technical detail in the complaint, a central issue will be evidentiary. The plaintiff will need to produce evidence that the Accused Product actually performs each of the claimed steps, including determining an "assessment," "updating" a plan based on "guidelines," and generating "compliance data."
- Technical Questions: A key question is whether the Accused Product’s functionality matches the specific sequence and logic of the claims. For example, does the service generate what could be legally defined as "compliance data"? Does it automatically "update" a pre-existing plan, or does it simply present data to a human provider who then makes a decision? The complaint does not provide sufficient detail for analysis of these points.
V. Key Claim Terms for Construction
The Term: "assessment guidelines"
- Context and Importance: This term is foundational to the "determining a current assessment" step. The scope of this term will be critical to infringement, as it defines the logic against which patient data must be compared. Practitioners may focus on this term because its definition will determine whether any rule-based system used by the accused service qualifies, or if more formal, clinically-recognized guidelines are required.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent specification refers to algorithms more generally, suggesting any rule set could suffice. For example, it describes making a clinical assessment "using an algorithm" and developing treatment plans using "customized guidelines or algorithms which are based on each patient's particular medical history" (’985 Patent, col. 3:41-42; col. 4:41-44).
- Evidence for a Narrower Interpretation: The background section repeatedly references established, authoritative guidelines, such as the "NIH Guidelines," as the standard for proper care, which could suggest the term implies formal, published clinical standards (’985 Patent, col. 1:44-49).
The Term: "existing treatment plan"
- Context and Importance: The claims require "updating an existing treatment plan." This term’s construction is important because it raises the question of whether the accused service must retrieve and modify a formalized, pre-recorded plan for a specific patient, or if any prior set of instructions could qualify.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent does not appear to explicitly define the term, which may support a plain and ordinary meaning that could encompass any set of prior treatment instructions for the patient.
- Evidence for a Narrower Interpretation: The system logic, particularly the step of comparing an "updated treatment plan with the prior treatment plan" ( Compl. ¶140), suggests the "existing treatment plan" is a formally stored data object within the system that can be retrieved and algorithmically updated, rather than a general concept of care (’985 Patent, col. 12:17-20).
VI. Other Allegations
- Indirect Infringement: The complaint alleges both induced and contributory infringement. Inducement is alleged based on Defendant knowing or having reason to know its acts would cause infringement by its users, with intent to encourage such infringement (Compl. ¶24-25). Contributory infringement is alleged on the basis that the Accused Product is especially made or adapted for use in an infringing combination, is a material part of the infringement, and has no substantial non-infringing uses (Compl. ¶26).
- Willful Infringement: Willfulness is alleged based on Defendant’s knowledge of the ’985 Patent. The complaint pleads knowledge both from "a time prior to Cardiomedix receiving this Complaint" and, at a minimum, from the date of service of the complaint itself (Compl. ¶25, ¶27).
VII. Analyst’s Conclusion: Key Questions for the Case
- An Evidentiary Question of Operation: The primary issue will be establishing the specific functionality of the "Telehealth/Cardiac Event Remote Monitoring Services." Does the service, in fact, perform every step of the claimed method, particularly the automated updating of a pre-existing, stored treatment plan based on an algorithmic assessment against defined guidelines?
- A Definitional Question of Scope: The case will likely turn on the construction of key terms like "assessment guidelines" and "existing treatment plan." The court’s interpretation will determine whether the accused service’s internal logic and data structures fall within the scope of the claims, or if there is a fundamental mismatch between the patented method and the accused service's operation.