DCT
1:25-cv-01351
Cleveland Medical Devices Inc v. ResMed Inc
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Cleveland Medical Devices Inc. (Ohio)
- Defendant: ResMed Inc. (Delaware)
- Plaintiff’s Counsel: Potter, Anderson & Corroon LLP
- Case Identification: 1:25-cv-01351, D. Del., 11/05/2025
- Venue Allegations: Plaintiff alleges venue is proper in the District of Delaware because Defendant is incorporated in Delaware and has committed acts of infringement within the district.
- Core Dispute: Plaintiff alleges that Defendant’s home sleep apnea testing products and associated software platforms infringe six patents related to remote sleep and signal analysis technology.
- Technical Context: The technology concerns portable systems for conducting sleep studies in a patient's home, aiming to provide a more convenient, cost-effective, and accurate alternative to traditional in-laboratory testing for disorders like obstructive sleep apnea.
- Key Procedural History: The complaint alleges that ResMed was aware of the asserted patents due to a prior lawsuit filed by Plaintiff in June 2022 in the same court, which asserted the same patents against ResMed's ApneaLink product line. Plaintiff further alleges that despite this knowledge, ResMed deliberately expanded its accused product portfolio by acquiring VirtuOx in May 2025.
Case Timeline
| Date | Event |
|---|---|
| 2007-06-08 | Earliest Priority Date for all Asserted Patents |
| 2016-01-01 | ResMed acquires Brightree (approximate date) |
| 2018-07-24 | U.S. Patent No. 10,028,698 Issues |
| 2019-10-01 | U.S. Patent No. 10,426,399 Issues |
| 2021-02-23 | U.S. Patent No. 10,925,535 Issues |
| 2021-07-20 | U.S. Patent No. 11,064,937 Issues |
| 2021-12-21 | U.S. Patent No. 11,202,603 Issues |
| 2022-02-01 | U.S. Patent No. 11,234,637 Issues |
| 2022-06-16 | Plaintiff files prior lawsuit against ResMed |
| 2023-03-20 | ResMed files related declaratory judgment action |
| 2025-05-01 | ResMed acquires VirtuOx |
| 2025-11-05 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 10,426,399 - Method and Device for In-Home Sleep and Signal Analysis
The Invention Explained
- Problem Addressed: The patent describes the drawbacks of traditional, laboratory-based sleep studies, which are noted as being expensive, having long waiting lists, and potentially yielding inaccurate results due to the unfamiliar testing environment (the "first night effect") ( Compl. Ex. 1, ’399 Patent, col. 1:17-2:4). Unattended home tests, meanwhile, historically lacked the ability to transmit data for real-time quality checks, leading to a high rate of unusable studies ( Compl. Ex. 1, ’399 Patent, col. 1:17-2:4).
- The Patented Solution: The invention is a method for conducting sleep analysis at home. It involves providing a patient with a portable interface box worn on the torso, which connects to sensors that measure physiological data such as airflow, respiratory effort, and blood oxygenation. The device collects, digitizes, and stores this data locally, and then transfers it to a remote location where a computer analyzes it to identify events indicative of a sleeping disorder (Compl. Ex. 1, ’399 Patent, Abstract; col. 3:5-20).
- Technical Importance: This approach sought to make the diagnosis of sleep disorders more accessible, affordable, and accurate by moving the study from a specialized laboratory into the patient's own home (Compl. ¶10).
Key Claims at a Glance
- The complaint asserts independent claim 1 (Compl. ¶69).
- The essential steps of Claim 1 include:
- Providing a subject with a portable patient interface box and associated sensors (nasal cannula, respiratory belt, pulse oximeter).
- Applying and connecting the sensors and interface box to the subject.
- Measuring and collecting airflow, respiratory effort, body position, and oxygenation data while the subject sleeps at home.
- Digitizing and storing the collected data in the interface box's nonvolatile memory.
- Transferring the collected data to a remote location.
- Providing a computer at the remote location to analyze the data to identify physiological or technological events indicative of a sleeping disorder.
- Performing further analysis to determine if the subject suffers from a sleeping disorder.
- The complaint does not explicitly reserve the right to assert dependent claims for this patent.
U.S. Patent No. 10,925,535 - Method and Device for In-Home Sleep and Signal Analysis
The Invention Explained
- Problem Addressed: The patent addresses the same challenges as the ’399 Patent: the high cost, inconvenience, and potential inaccuracy of in-lab sleep studies, and the unreliability of prior-art unattended home tests (Compl. Ex. 2, ’535 Patent, col. 1:17-2:4).
- The Patented Solution: This patent claims a system for at-home sleep analysis. The system comprises a portable, wearable patient interface box (with a processor, memory, transceiver, and specific sensors) that collects physiological data, and a remote database connected to software that is configured to receive the data and automatically analyze it to identify events indicative of a sleeping disorder (Compl. Ex. 2, ’535 Patent, Abstract; col. 3:5-20).
- Technical Importance: The claimed system provides the integrated hardware and software architecture to enable the reliable remote sleep testing method described in related patents (Compl. ¶10).
Key Claims at a Glance
- The complaint asserts independent claim 8 (Compl. ¶99).
- The essential components of the system of Claim 8 include:
- A portable patient interface box worn on the torso, comprising a battery, kinetic sensor, nonvolatile memory, pressure transducer, air port, and a processor.
- At least three sensors to be applied to a subject: a nasal cannula/facemask, a respiratory effort belt, and a fingertip pulse oximeter.
- A database that is remote from the subject and adapted for receiving the collected data from a transceiver.
- Software stored on a computer-readable medium, adapted to automatically analyze the collected data from the database to identify physiological or technological events indicative of a sleeping disorder.
- The complaint also asserts Claim 15 (an indirect infringement claim) (Compl. ¶114).
Multi-Patent Capsule: U.S. Patent No. 11,064,937
- Patent Identification: U.S. Patent No. 11064937, Method and Device for In-Home Sleep and Signal Analysis, issued July 20, 2021 (Compl. ¶16).
- Technology Synopsis: The patent describes a system for remote sleep testing using a specified set of sensors (nasal cannula, respiratory effort belt, pulse oximeter), a portable interface box with a processor and memory, a remote database, and software to analyze the collected data for events indicative of a sleeping disorder (Compl. ¶17).
- Asserted Claims: Claim 13 (Compl. ¶127).
- Accused Features: The complaint alleges infringement by the ResMed HST Solutions, which are said to embody the claimed system for conducting remote sleep analysis (Compl. ¶132).
Multi-Patent Capsule: U.S. Patent No. 10,028,698
- Patent Identification: U.S. Patent No. 10028698, Method and Device for Sleep Analysis, issued July 24, 2018 (Compl. ¶18).
- Technology Synopsis: The patent is directed to a method for remote sleep analysis that involves applying at least two sensors to a subject, connecting them to an interface box that collects and transmits data to a remote electronic interface, and analyzing the data to identify events for medical diagnosis (Compl. ¶19).
- Asserted Claims: Claim 14 (Compl. ¶156).
- Accused Features: The complaint alleges the use of the ResMed HST Solutions constitutes performance of the claimed method of remote sleep analysis and diagnosis (Compl. ¶161).
Multi-Patent Capsule: U.S. Patent No. 11,202,603
- Patent Identification: U.S. Patent No. 11202603, Method and Device for Sleep Analysis, issued December 21, 2021 (Compl. ¶20).
- Technology Synopsis: The patent describes sleep diagnostic systems and methods involving sensors that measure airflow/snore, respiratory effort, and blood oxygenation. The data is then analyzed for a medical professional (Compl. ¶21).
- Asserted Claims: Claim 8 (Compl. ¶187).
- Accused Features: The complaint alleges the ResMed HST Solutions embody the claimed sleep diagnostic system, functioning as portable, wearable patient interface boxes with the required sensors, remote database, and analysis software (Compl. ¶¶193-201).
Multi-Patent Capsule: U.S. Patent No. 11,234,637
- Patent Identification: U.S. Patent No. 11234637, Method and Device for In-Home Sleep and Signal Analysis, issued February 1, 2022 (Compl. ¶22).
- Technology Synopsis: The patent discloses systems for conducting home sleep analysis using devices that obtain airflow, respiratory effort, blood oxygenation, and body position data. This data can be transmitted to software that identifies events indicative of a sleeping disorder (Compl. ¶23).
- Asserted Claims: Claim 1 (Compl. ¶219).
- Accused Features: The complaint alleges the ApneaLink Air solution embodies the claimed system, providing a portable interface box with the specified sensors and software for remote analysis (Compl. ¶¶225-231).
III. The Accused Instrumentality
Product Identification
The accused instrumentalities are ResMed’s ApneaLink Air Solution and Alice NightOne Solution, collectively referred to as the "HST Solutions" or "VirtuOx Solutions" (Compl. ¶35). These solutions include hardware devices (ApneaLink Air, Alice NightOne) and associated software and data management platforms (ApneaLink Software, AirView Cloud Platform, Sleepifi) (Compl. ¶¶40, 53).
Functionality and Market Context
The accused products are "type III HSAT (home sleep apnea test) devices" that a patient wears at home to record physiological data, including respiratory effort, pulse, oxygen saturation, and nasal flow (Compl. ¶¶35, 41). The ApneaLink Air device is shown worn around a patient's torso to detect events indicative of sleep apnea (Compl. ¶41, Ex. 26 at 2). The collected data is transferred from the hardware devices to software platforms, which automatically analyze the data, generate reports, and share the results with medical professionals (Compl. ¶¶36, 48, 51). The complaint includes a sample report from the ApneaLink software showing a detailed analysis of a patient's sleep, including an Apnea-Hypopnea Index (AHI) chart (Compl. ¶49, Ex. 17 at 4). ResMed is alleged to offer these solutions through its subsidiary VirtuOx, a diagnostic testing facility acquired to address a "bottleneck" in the U.S. sleep testing market (Compl. ¶¶33-34).
IV. Analysis of Infringement Allegations
U.S. Patent No. 10,426,399 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| providing a subject with a portable patient interface box worn on its torso and a nasal cannula or a facemask, a respiratory effort belt and a fingertip pulse oximeter... | ResMed provides subjects with the ApneaLink Air and Alice NightOne devices, which are portable patient interface boxes worn on the torso, along with a nasal cannula, respiratory effort belt, and pulse oximeter. | ¶74 | col. 27:35-51 |
| applying and connecting the nasal cannula or facemask, the respiratory effort belt and the fingertip pulse oximeter to the subject, and further the patient interface box to the subject's torso | ResMed provides instructions and the devices are designed for patients or providers to apply and connect the sensors and interface box to the subject's torso. | ¶76 | col. 27:52-56 |
| measuring and collecting data through the patient interface box of the airflow, respiratory effort, body position or orientation and oxygenation of the subject while the subject attempts to sleep at home | The ApneaLink Air and Alice NightOne devices measure and collect data on airflow, respiratory effort, body position, and oxygenation while the subject sleeps at home. | ¶77 | col. 27:57-62 |
| digitizing and storing the collected data from the subject in the nonvolatile digital memory of the patient interface box | The ApneaLink Air and Alice NightOne devices digitize and store the collected data in their internal nonvolatile digital memory. | ¶78 | col. 27:63-66 |
| transferring the collected data to a location remote from the subject's home | The devices transfer the collected data to a computer at a remote location running software platforms like AirView, ApneaLink Software, and Sleepifi. | ¶79 | col. 27:67-28:1 |
| providing a computer or a processor at the remote location for analyzing the transferred collected data to identify and draw attention to physiological or technological events in the data indicative of a sleeping disorder | The remote software platforms (AirView, ApneaLink Software, Sleepifi) analyze the data to identify and highlight physiological and technological events. | ¶80 | col. 28:2-7 |
| and further analyzing at a minimum the transferred collected data and/or the identified physiological and technological events... to determine whether the subject suffers from a sleeping disorder. | The software provides further analysis, reports, and customizable tools to determine if the subject has a sleeping disorder. | ¶81 | col. 28:8-13 |
U.S. Patent No. 10,925,535 Infringement Allegations
| Claim Element (from Independent Claim 8) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a portable patient interface box adapted to be worn by the subject on their torso... comprising a battery, at least one kinetic sensor for measuring body position, a nonvolatile digital memory, a pressure transducer, an air port... and a processor... | The ApneaLink Air device is a portable interface box worn on the torso that includes a battery, a kinetic sensor for body position, nonvolatile digital memory, a pressure transducer, an air port, and a processor. | ¶105 | col. 29:39-51 |
| at least three sensors adapted to be applied to a subject... comprising: a nasal cannula or a facemask... a respiratory effort belt... and a fingertip pulse oximeter... | The ApneaLink Air system includes a nasal cannula for measuring airflow, a respiratory effort belt, and a fingertip pulse oximeter for measuring oxygenation. | ¶104 | col. 29:52-58 |
| a database adapted to be remote from the subject for receiving the collected data transferring from the transceiver on the portable patient interface box; | The ApneaLink Software, AirView, and Sleepifi platforms contain a database remote from the subject that receives the collected data from the ApneaLink Air's transceiver. | ¶107 | col. 29:59-62 |
| and software stored on a computer readable storage medium and when executed... to automatically analyze the collected data from the database to identify and draw attention to physiological or technological events in the data indicative of a sleeping disorder. | The ApneaLink Software, AirView, and Sleepifi platforms are software that automatically analyze the received data to identify and highlight events indicative of a sleeping disorder, such as generating reports on apnea-hypopnea indices. | ¶108 | col. 29:63-30:2 |
Identified Points of Contention
- Scope Questions: For method claim 1 of the ’399 Patent, which requires actions by both ResMed (providing the device) and the end-user (applying and using it), a central issue may be divided infringement. The analysis will question whether the complaint’s allegations that ResMed "directs and controls the methods" (Compl. ¶73) are sufficient to hold ResMed liable for direct infringement for steps it does not perform itself.
- Technical Questions: The claims require analysis to "identify and draw attention to physiological or technological events." A technical question is whether the accused software's function of calculating and displaying aggregate indices, such as the Apnea-Hypopnea Index (AHI) shown in an exemplary report (Compl. Ex. 17 at 4), meets this limitation, or if the claim requires the identification of discrete, individual events (e.g., a specific apnea or desaturation event).
V. Key Claim Terms for Construction
- The Term: "analyzing the transferred collected data to identify and draw attention to physiological or technological events in the data indicative of a sleeping disorder" (from ’399 Patent, Claim 1)
- Context and Importance: This term defines the core analytical function required for infringement. Its construction will be critical in determining whether the processing performed by ResMed's software platforms—which includes generating summary indices like AHI—falls within the scope of the claim. Practitioners may focus on whether "identifying events" requires flagging discrete occurrences or if calculating diagnostic scores suffices.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification of the parent ’698 Patent states a goal is the "analysis of the data... to determine whether the patient suffers from a sleep disorder" (’698 Patent, col. 4:48-50). This language may support a construction focused on the overall diagnostic purpose rather than the specific mechanics of event flagging.
- Evidence for a Narrower Interpretation: The specification also describes software that can "alert a individual... when a physiological event (such as a drop in oxygen saturation) or a technological event (such as an electrode becoming disconnected) occurs" (’698 Patent, col. 4:13-17). The complaint itself references a table of specific "default event types automatically detected by the ApneaLink program," including various apneas, hypopnea, and desaturation, which may support a narrower construction requiring the identification of such discrete events (Compl. ¶41, Ex. 27 at 26).
- The Term: "a database that is remote from the subject" (from ’535 Patent, Claim 8)
- Context and Importance: The accused systems involve data transfer from a device to a local computer and then potentially to a cloud-based platform (Compl. ¶¶47, 51). The definition of "database" is important to determine which part of this architecture satisfies the claim limitation. Practitioners may focus on this term because its scope could determine whether infringement occurs at the local software level, the cloud level, or both.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification describes transmitting data to "a sleep analysis unit or lab or to a database accessible to individuals from the sleep analysis unit or lab" (’698 Patent, col. 4:45-48). This could be interpreted broadly to encompass any data repository, including one on a local computer, that is remote from the patient and accessible to clinicians.
- Evidence for a Narrower Interpretation: The patent's figures depict data being transmitted from a "remote station" over the internet to other review stations or a central database (’698 Patent, Fig. 5). This architecture, which separates the initial data aggregation point from the ultimate database, may support a narrower interpretation that the claimed "database" refers to a centralized, cloud-based system like AirView, not local storage.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that ResMed induces infringement by instructing and encouraging customers and users, through user manuals, clinical guides, and other materials, to perform the steps of the asserted method claims (e.g., Compl. ¶¶88-89, 116-117). It further alleges contributory infringement on the basis that ResMed provides essential material components of the inventions—the hardware devices and proprietary software—that are not staple articles of commerce and are specifically adapted for infringing use (e.g., Compl. ¶¶90-91, 118-119).
- Willful Infringement: Willfulness is alleged based on ResMed's purported knowledge of the asserted patents since at least June 2022, stemming from a prior lawsuit filed by CleveMed asserting the same patents against ResMed's ApneaLink product (Compl. ¶¶62, 83). The complaint alleges that ResMed's subsequent acquisition of VirtuOx and expansion of its infringing activities to include the Alice NightOne solution, despite this knowledge, constitutes willful and egregious disregard for CleveMed's patent rights (Compl. ¶¶64, 84).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central legal issue will be one of divided infringement liability: For the asserted method claims, the court will need to determine if Plaintiff can prove that ResMed "directs or controls" the actions of patients and healthcare providers to a degree sufficient to attribute their use of the accused devices to ResMed for the purpose of direct infringement.
- A key question of fact will concern willfulness and damages: Given the allegation of a prior, pending lawsuit involving the same patents, a central issue will be whether ResMed’s post-suit business decisions, including the acquisition of VirtuOx and the launch of additional accused products, constitute willful infringement that would warrant enhanced damages under 35 U.S.C. § 284.
- A core technical question will be one of functional scope: The case may turn on whether the automated analysis performed by ResMed's software, which generates summary reports and diagnostic indices, performs the specific claimed step of "identify[ing] and draw[ing] attention to physiological or technological events," or if a meaningful distinction exists between calculating aggregate scores and identifying discrete events as taught in the patents.