MY Health Inc v. DeVilbiss Healthcare LLC

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: My Health, Inc. (Delaware)
  • Defendant: DeVilbiss Healthcare, LLC (Delaware)
  • Plaintiff’s Counsel: Pia Anderson Dorius Reynard & Moss; Capshaw DeRieux, L.L.P.
• Case Identification: 2:16-cv-00544, E.D. Tex., 05/20/2016
• Venue Allegations: Venue is based on Defendant allegedly transacting business and committing acts of infringement in the Eastern District of Texas. This includes distributing products through dozens of local healthcare facilities, employing sales representatives in the state, selling products online to district residents, and sponsoring a clinical trial involving a principal investigator who resides and works in the district.
• Core Dispute: Plaintiff alleges that Defendant’s respiratory therapy products, which remotely monitor patients and adjust treatment, infringe a patent related to methods and systems for monitoring and treating patients with chronic conditions.
• Technical Context: The technology relates to remote healthcare systems that collect both objective and subjective patient data, use established medical guidelines to assess a patient's condition, and automatically update treatment plans.
• Key Procedural History: Plaintiff alleges that Defendant has had actual knowledge of the patent-in-suit since at least June 2014, when Plaintiff's licensing agent allegedly provided Defendant with a copy of the patent and a preliminary claim chart. The complaint also notes that the patent was assigned from the University of Rochester to the Plaintiff and that Plaintiff has licensed the patent to over 40 other companies.

Case Timeline

Date	Event
2001-02-26	’985 Patent Priority Date
2003-09-02	’985 Patent Issue Date
2014-06-01	Alleged Pre-Suit Notice to Defendant
2016-05-20	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 describes the challenge of providing consistent, guideline-based care for patients with chronic illnesses like asthma, who are often managed remotely. It notes that prior art systems failed to incorporate subjective patient-reported data, did not customize treatment based on a patient's specific medical history, and could not directly notify emergency services when necessary (’985 Patent, col. 1:12-32, col. 2:5-12).
• The Patented Solution: The invention is a networked healthcare system that determines a "current assessment" of a patient's condition by combining objective data (e.g., from a medical device) and subjective data (e.g., patient-reported symptoms) with pre-existing "assessment guidelines" (’985 Patent, Abstract). Based on this assessment, the system automatically updates an existing treatment plan and transmits it back to the remote patient, creating a closed-loop system for managing chronic care (’985 Patent, col. 4:1-20, FIG. 4).
• Technical Importance: The claimed approach sought to improve remote care by automating the application of established clinical guidelines (e.g., from the NIH) to individual patient data, thereby personalizing treatment and improving compliance for chronic conditions (’985 Patent, col. 4:21-30).

Key Claims at a Glance

• The complaint asserts independent method claim 1, independent system claim 4, and independent computer-readable medium claim 7 (Compl. ¶30, ¶32).
• The 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 one or more assessment guidelines.
  • Updating an existing treatment plan based on the existing plan, the current assessment, and treatment guidelines to generate an updated plan.
  • Reviewing the updated treatment plan.
  • Determining if changes are needed to the reviewed plan.
  • Changing the plan if changes are needed.
  • Providing the patient with the reviewed treatment plan.
  • Generating and providing compliance data based on the updated and reviewed treatment plans.
• The complaint reserves the right to assert additional claims (Compl. ¶30).

III. The Accused Instrumentality

Product Identification

The DeVilbiss Healthcare Sleep Cube Models and Smart Link (Compl. ¶30).

Functionality and Market Context

The complaint alleges these are respiratory medical products used for CPAP therapy (Compl. ¶13, ¶31c). The system is alleged to perform "remote monitoring and assessment of a patient's sleep and breathing activities" (Compl. ¶31a). A core accused feature is an "autoadjusting algorithm that responds to apnoeas, hypopnoeas, and snoring to deliver the most effective therapy whilst sleeping" (Compl. ¶31b). The system is also described as a "comprehensive therapy management system" that records usage, evaluates therapy effectiveness, and provides "insightful data that can be used to determine the patients' compliance" (Compl. ¶31c, ¶31g).

IV. Analysis of Infringement Allegations

The complaint's infringement theory is narratively mapped to the steps of method claim 1 (Compl. ¶31). 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 accused product determines an assessment through remote monitoring of a patient's sleep and breathing activities.	¶31a	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... to generate an updated treatment plan...	The system uses an "autoadjusting algorithm that responds to apnoeas, hypopnoeas, and snoring" to update the therapy plan.	¶31b	col. 2:25-30
reviewing the updated treatment plan for each of the diagnosed conditions	The system provides a "comprehensive therapy management system for monitoring and recording CPAP usage and evaluating the effectiveness of CPAP therapy."	¶31c	col. 4:15-17
determining if one or more changes are needed to the reviewed treatment plan...	The system determines if changes are needed by sensing breathing patterns and, upon detecting a sleep event, automatically adjusting pressure.	¶31d	col. 12:44-54
changing the reviewed treatment plan if the one or more changes are determined to be needed	The system changes the treatment plan by "autoadjusting pressure and other aspects of the treatment plan upon detection of a sleep event."	¶31e	col. 13:1-11
providing the patient with the reviewed treatment plan for each of the diagnosed conditions	The system provides the patient with information such as pressure, leak rate, and breathing parameters via its communication system.	¶31f	col. 13:16-23
generating and providing compliance data based on the updated treatment plan and the reviewed treatment plan for each of the diagnosed conditions	The platform generates data "that can be used to determine the patients' compliance" and provides parameters to "optimize patient therapy management."	¶31g	col. 4:17-20

• Identified Points of Contention:
  • Scope Questions: A central dispute may concern whether the defendant's "autoadjusting algorithm," which allegedly responds to immediate physiological events like snoring, qualifies as being based on "assessment guidelines" as that term is used in the patent. The complaint does not specify what "guidelines" the accused product uses, raising the question of whether its function aligns with the patent's focus on established clinical protocols.
  • Technical Questions: The complaint relies on marketing descriptions from the defendant's website. A factual question will be whether the accused product's actual operation performs each of the discrete method steps as claimed. For example, does the system's function of "monitoring and recording CPAP usage" (Compl. ¶31c) constitute "reviewing the updated treatment plan" for the purpose of deciding on further changes, as required by the sequence of claim 1?

V. Key Claim Terms for Construction

• "assessment guidelines"
  • Context and Importance: The construction of this term is critical to infringement. The case may turn on whether the accused product's internal, real-time pressure-adjustment algorithm constitutes an "assessment guideline." Practitioners may focus on this term because the patent's specification appears to contemplate a different type of guideline than what a standard auto-CPAP machine might use.
  • Intrinsic Evidence for a Broader Interpretation: The patent states that an algorithm can be "based upon or adapted from existing guidelines" (’985 Patent, col. 3:56-59), which could suggest that any rule-based system for assessment, however simple, falls within the claim scope.
  • Intrinsic Evidence for a Narrower Interpretation: The specification repeatedly provides examples of formal, published standards, such as the "NIH Guidelines" for asthma (’985 Patent, col. 1:49-56). This may support an argument that "assessment guidelines" must be a set of established clinical standards, not merely the internal logic of a device's feedback loop.
• "compliance data"
  • Context and Importance: Claim 1 concludes with a step of "generating and providing compliance data." The nature of this data is central to determining if the accused system performs the full, claimed method. The infringement allegation rests on the accused product providing data to "determine the patients' compliance" (Compl. ¶31g).
  • Intrinsic Evidence for a Broader Interpretation: This could be read to cover any data reflecting patient usage of the device, such as the number of hours a CPAP machine was used per night.
  • Intrinsic Evidence for a Narrower Interpretation: The patent links compliance not just to patient actions, but also to physician adherence to "prescribed treatment guidelines" and provides for analysis by third parties like HMOs and review boards (’985 Patent, col. 4:55-61, col. 14:1-11). This suggests "compliance data" may require more than simple usage logs, potentially including information that compares patient and provider actions against a formal treatment protocol.

VI. Other Allegations

• Indirect Infringement: The complaint alleges both induced and contributory infringement (Compl. ¶33-35). The allegations are based on claims that Defendant knew its products would be used to infringe, intended to encourage such use by its end users, and that the products were especially adapted for infringement with no substantial non-infringing uses (Compl. ¶34-35).
• Willful Infringement: Willfulness is alleged based on pre-suit knowledge. The complaint asserts that Defendant received "actual notice" of the ’985 Patent in June 2014 from Plaintiff's licensing agent, who allegedly provided a copy of the patent and a "preliminary claim chart" (Compl. ¶14, ¶34).

VII. Analyst’s Conclusion: Key Questions for the Case

• A core issue will be one of definitional scope: can the term "assessment guidelines," which the patent specification repeatedly associates with formal clinical protocols like those from the NIH, be construed to cover the proprietary, real-time physiological feedback algorithm alleged to be in the accused auto-adjusting CPAP device?
• A key evidentiary question will be one of functional performance: does the accused system, in its actual operation, perform each discrete step of the claimed method in sequence? Specifically, what evidence will show that the system performs a "reviewing" step that informs a decision to make changes, and does it generate "compliance data" that aligns with the patent's concept of tracking adherence to broader treatment regimens, or do the allegations conflate general data logging with these specific claimed functions?