DCT
2:16-cv-00535
MY Health Inc v. Alr Tech Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: MY Health Inc (Delaware)
- Defendant: Alr Technologies Inc (Nevada)
- Plaintiff’s Counsel: Pia Anderson Dorius Reynard & Moss; Capshaw Derieux LLP
- Case Identification: 2:16-cv-00535, E.D. Tex., 05/19/2016
- Venue Allegations: Plaintiff alleges venue is proper in the Eastern District of Texas because Defendant transacts business, sells products, employs sales representatives, and places accused products into the stream of commerce within the district.
- Core Dispute: Plaintiff alleges that Defendant’s remote patient monitoring system infringes a patent related to methods and systems for monitoring and treating patients with chronic conditions.
- Technical Context: The technology concerns internet-based health management systems that collect patient data remotely, analyze it against clinical guidelines, and facilitate updates to treatment plans.
- Key Procedural History: The complaint alleges that Plaintiff’s licensing agent contacted Defendant in January 2015 and provided a preliminary claim chart, putting Defendant on actual notice of the patent-in-suit. Plaintiff also states it has granted more than 40 licenses to the patent.
Case Timeline
| Date | Event |
|---|---|
| 2001-02-26 | '985 Patent Priority Date |
| 2003-09-02 | '985 Patent Issue Date |
| 2015-01-01 | (approx.) Defendant allegedly received notice of '985 Patent |
| 2016-05-19 | 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’s background section describes the challenge of providing consistent, ongoing care for patients with chronic illnesses like asthma, noting that many patients do not receive treatment in accordance with recommended guidelines, leading to preventable hospitalizations and poor outcomes (’985 Patent, col. 1:11-30).
- The Patented Solution: The invention is a remote health monitoring system that determines a "current assessment" of a patient’s condition by collecting both objective data (e.g., from a medical device) and subjective data (e.g., patient-reported symptoms) from a remote patient. This information is processed against established "assessment guidelines" to update an existing "treatment plan," which is then transmitted back to the patient (’985 Patent, Abstract; col. 2:15-32). The system is designed to automate and individualize patient care between doctor visits, as illustrated in the system flowchart (’985 Patent, Fig. 4).
- Technical Importance: At the time of the invention, internet-based monitoring of chronically ill patients was described as being "in its infancy" but represented an attractive platform for patient surveillance that could potentially lower health costs and reduce emergency room visits (’985 Patent, col. 1:56-65).
Key Claims at a Glance
- The complaint asserts independent method Claim 1, independent system Claim 4, and independent computer-readable medium Claim 7 (Compl. ¶26).
- Essential elements of independent Claim 1 include:
- Determining a current assessment of a patient's condition based on data from the remote patient and on assessment guidelines.
- Updating an existing treatment plan based on the existing plan, the current assessment, and treatment guidelines.
- Reviewing the updated treatment plan.
- Determining if changes are needed to the reviewed plan.
- Changing the reviewed plan if changes are needed.
- Providing the patient with the reviewed treatment plan.
- Generating and providing compliance data based on the updated and reviewed plans.
- The complaint reserves the right to assert additional claims (Compl. ¶26).
III. The Accused Instrumentality
Product Identification
The ALRT Health e-Connect (the "Accused Product") (Compl. ¶26).
Functionality and Market Context
The complaint alleges the Accused Product is a patient monitoring system that allows healthcare providers to remotely track patient health conditions (Compl. ¶27a). Its functionality is alleged to include reviewing patient data according to "clinician approved protocols" to determine if patients are adhering to their care plan and if their blood glucose levels require intervention (Compl. ¶27b, d). Based on this review, the system allegedly recommends corrections to the patient's care plan, provides coaching, and gives remote medical support (Compl. ¶27b). The complaint describes a key component as "Diabetes Care Facilitators (DCFs)" who regularly review the data and testing frequency (Compl. ¶27d).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in 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 for each of the diagnosed conditions | The system remotely tracks patient health conditions and management activities, monitoring the patient's health status between office visits. | ¶27a | col. 2:18-25 |
| 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 | The system generates an updated treatment plan through facilitators who review data according to clinician-approved protocols to determine if intervention is required. | ¶27b | col. 2:25-30 |
| reviewing the updated treatment plan for each of the diagnosed conditions | The system sends data between the patient and provider for analysis, with population management capabilities allowing facilitators to focus on patients needing attention based on clinician-set criteria. | ¶27c | col. 16:6-9 |
| determining if one or more changes are needed to the reviewed treatment plan for each of the diagnosed conditions | Diabetes Care Facilitators review patient data and testing frequency against clinician-approved protocols to determine if patients are adhering to care plans or require intervention. | ¶27d | col. 17:7-10 |
| changing the reviewed treatment plan if the one or more changes are determined to be needed | The system recommends corrections to the patient's care plan. | ¶27e | col. 17:11-13 |
| providing the patient with the reviewed treatment plan for each of the diagnosed conditions | The system uses a communications platform with secure messaging, text, and email to coordinate communication between patients and providers. | ¶27f | col. 17:14-17 |
| generating and providing compliance data based on the updated treatment plan and the reviewed treatment plan for each of the diagnosed conditions | The system's platform can be queried to see which patients are not adhering to their care plan and includes "metrics and reminders" for performance tracking. | ¶27g | col. 17:18-23 |
Identified Points of Contention
- Scope Questions: A central dispute may arise over the term "guidelines." The patent frequently uses NIH guidelines for asthma as its primary example (’985 Patent, col. 1:40-49). The infringement analysis will raise the question of whether the defendant's "clinician approved protocols" (Compl. ¶27d) fall within the scope of "assessment guidelines" and "treatment guidelines" as contemplated by the patent.
- Technical Questions: The complaint describes "Diabetes Care Facilitators (DCFs)" as "regularly review[ing] the data" (Compl. ¶27d). This raises the question of whether the accused system itself performs the claimed method steps of "determining," "updating," and "reviewing," or if these actions are performed by human facilitators interacting with the system. This could introduce arguments related to divided infringement, where no single entity performs all steps of the claimed method.
V. Key Claim Terms for Construction
- The Term: "assessment guidelines" / "treatment guidelines" (Claim 1)
- Context and Importance: The construction of "guidelines" is critical to the infringement analysis. If the term is construed narrowly to require formal, publicly promulgated standards (like those from the NIH), the allegation that Defendant's internal "clinician approved protocols" (Compl. ¶27d) meet this limitation may be weakened. A broader construction covering any set of predefined rules for patient assessment and treatment would favor the infringement allegation.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claims themselves use the general term "guidelines" without express limitation to a specific source or type (’985 Patent, col. 16:55-65). The specification also refers more generally to "established guidelines" without always tying them to a specific body like the NIH (’985 Patent, col. 9:43-49).
- Evidence for a Narrower Interpretation: The patent specification repeatedly and specifically references the "NIH Guidelines" for asthma as a principal example of the type of guidelines the invention is designed to implement (’985 Patent, col. 1:40-49; col. 4:26-30). A party could argue that this repeated emphasis limits the term's scope to similar, authoritative, and externally-published standards.
VI. Other Allegations
- Indirect Infringement: The complaint alleges both induced and contributory infringement. Inducement is based on allegations that Defendant acted with knowledge and intent to encourage infringement by its users (Compl. ¶¶29-30). Contributory infringement is based on allegations that the Accused Products are especially made or adapted for an infringing use, are a material part of the infringement, and have no substantial non-infringing uses (Compl. ¶31).
- Willful Infringement: Willfulness is alleged based on Defendant’s purported actual knowledge of the ’985 Patent since at least January 2015, when Plaintiff’s licensing agent allegedly contacted Defendant and provided a preliminary claim chart (Compl. ¶¶13, 32). The complaint alleges that Defendant’s infringement has continued despite this knowledge.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: can the term "guidelines," which is exemplified in the patent by formal NIH standards for asthma, be construed to cover the "clinician approved protocols" allegedly used by the accused diabetes management system?
- A key evidentiary question will be one of attribution of action: do the automated functions of the accused ALRT Health e-Connect system perform all the steps of the claimed method, or are essential steps—such as "determining if...changes are needed"—performed by human "Diabetes Care Facilitators" in a manner that could potentially divide the infringing acts between the system and its users, thereby complicating a finding of direct infringement?