DCT
1:23-cv-02221
ResMed Corp v. Cleveland Medical Devices Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: ResMed Corp. (Minnesota)
- Defendant: Cleveland Medical Devices, Inc. (Ohio)
- Plaintiff’s Counsel: DLA Piper LLP (US)
- Case Identification: 1:23-cv-02221, S.D. Cal., 03/20/2023
- Venue Allegations: Plaintiff ResMed Corp. alleges that venue is proper in the Southern District of California because Defendant Cleveland Medical Devices, Inc. is subject to personal jurisdiction in the district for this action and therefore "resides" there for venue purposes. Plaintiff also notes that it has a principal place of business in the district, and that relevant witnesses and evidence are located there.
- Core Dispute: Plaintiff seeks a declaratory judgment that its continuous positive airway pressure (CPAP) devices and ventilators do not infringe Defendant's patent related to systems for remotely diagnosing and treating sleep disorders.
- Technical Context: The technology concerns networked medical devices for treating sleep apnea, where a patient's device communicates with a cell phone and a remote server to enable automated, data-driven adjustments to therapy.
- Key Procedural History: This declaratory judgment action was filed in the context of an ongoing patent infringement lawsuit in the District of Delaware, where Defendant has accused Plaintiff's parent company (ResMed Inc.) of infringing related patents. Plaintiff asserts that the patent-in-suit here, which recently issued from the same family, was drafted in an attempt to cover Plaintiff's products, creating an immediate controversy.
Case Timeline
| Date | Event |
|---|---|
| 2005-11-04 | Earliest Priority Date for U.S. Patent No. 11,602,284 |
| 2022-06-16 | Delaware Action filed by CleveMed against ResMed Inc. |
| 2023-03-14 | U.S. Patent No. 11,602,284 Issues |
| 2023-03-20 | Complaint for Declaratory Judgment of Noninfringement Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 11,602,284 - Devices and Methods for Sleep Disorder Diagnosis and Treatment
- Patent Identification: U.S. Patent No. 11,602,284, issued March 14, 2023.
The Invention Explained
- Problem Addressed: The patent's background section describes conventional methods for diagnosing and treating sleep disorders as being either subjective, or requiring expensive and inconvenient all-night stays at specialized clinics (’284 Patent, col. 1:48-63). It further notes that existing treatment devices, such as basic CPAP machines, are often "largely ineffective" because they cannot be adjusted based on a patient's real-time physiological state or symptoms (’284 Patent, col. 2:32-45).
- The Patented Solution: The invention is an "integrated sleep diagnosis and treatment" system that aims to create a "closed loop system" for patient care (’284 Patent, col. 2:50-54, Abstract). The system uses physiological sensors to collect data from a patient, a processor to analyze this data and determine the severity of a sleep disorder, and a treatment device (e.g., a CPAP machine) that can be automatically adjusted based on the analysis, all potentially without direct human intervention (’284 Patent, col. 3:1-13). A central feature is the communication architecture, which involves a local patient device, a cell phone, and a remote internet site (’284 Patent, Claim 1).
- Technical Importance: This technology represents a move toward automated, data-driven, and remote management of chronic sleep disorders, intended to improve therapeutic outcomes and patient convenience (’284 Patent, col. 2:46-59).
Key Claims at a Glance
- The complaint focuses its non-infringement arguments on independent claim 1 and several dependent claims (Compl. ¶¶36-40).
- The essential elements of independent claim 1 are:
- A positive airway pressure (PAP) sleep disorder treatment system comprising a non-transitory computer readable medium with software for a cell phone, the cell phone itself (with a "first radio frequency wireless transceiver"), a PAP device, and a remote internet site.
- The PAP device includes an enclosure containing a blower, an airflow sensor, a "second processor" for calculating symptom severity and usage data, and a "second radio frequency wireless transceiver" for transmitting this data.
- The remote internet site is adapted to receive the data that was generated by the PAP device and "transmitted via the at least one second radio frequency wireless transceiver."
- The complaint seeks a declaratory judgment of non-infringement for all claims 1-20 of the ’284 patent (Compl. ¶34).
III. The Accused Instrumentality
Product Identification
- The "ResMed Accused Products" are identified as the ResMed Astral and Stellar ventilators, and the AirSense 10, AirCurve 10, AirSense 11, and AirMini CPAP devices (Compl. ¶21).
Functionality and Market Context
- The complaint describes the accused products as ventilators and CPAP devices used to treat sleep-disordered breathing (Compl. ¶¶2, 21). The non-infringement allegations focus on the specific hardware components and data communication pathways of these products. For instance, the complaint alleges that the Astral and Stellar ventilators lack any wireless transceiver in their enclosure, a required component of the claimed PAP device (Compl. ¶36). For the AirMini CPAP device, the complaint alleges that data is sent to a cell phone via Bluetooth, and any subsequent transmission to a remote server is performed by the cell phone’s transmitter, not by a "second" transmitter located within the AirMini device itself (Compl. ¶¶36, 38). The complaint positions ResMed as a "global leader in digital health and cloud-connected medical devices" (Compl. ¶2).
No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
’284 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Non-Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a non-transitory computer readable medium comprising a first software... configured to be used with a cell phone to display... an index of treatment efficacy | Plaintiff alleges that its cell phone software applications do not support the Astral and Stellar products and thus do not display an "index of treatment efficacy" for those devices. | ¶36 | col. 23:60-24:4 |
| the PAP device with an enclosure further comprising: ... at least one second radio frequency wireless transceiver | The complaint asserts that the ResMed Astral and Stellar ventilators do not have any wireless transceiver within their enclosure as required by the claim. | ¶36 | col. 24:25-27 |
| a remote internet site, the remote internet site adapted to receive the data... transmitted via the at least one second radio frequency wireless transceiver | It is alleged that for the AirMini device, data is sent to the cell phone via a first transmitter (Bluetooth). The remote site receives data from the cell phone's transmitter, not from the claimed "second" transceiver within the PAP device. | ¶36 | col. 24:28-35 |
| a second processor adapted... for calculating the data of usage of the PAP device | The complaint alleges the ResMed AirMini CPAP device does not practice this limitation. | ¶36 | col. 24:18-24 |
Identified Points of Contention
- Scope Questions: A central dispute will likely involve the interpretation of the system's required architecture. The disposition of the case may depend on whether the claim term "PAP device with an enclosure further comprising... at least one second radio frequency wireless transceiver" requires the transceiver to be physically located within the main housing of the PAP device. The complaint’s arguments suggest Plaintiff will argue for this narrow, integrated construction (Compl. ¶36).
- Technical Questions: The analysis will raise a factual question about the data communication pathway in the accused systems. What evidence will show whether the remote site receives data "transmitted via" the transceiver in the PAP device, as opposed to being relayed by the cell phone's separate transmitter? The answer will depend on a technical examination of how the products are designed to operate (Compl. ¶38).
V. Key Claim Terms for Construction
"at least one second radio frequency wireless transceiver" (in the PAP device)
- Context and Importance: This term is critical because Plaintiff's non-infringement theory for several products hinges on its absence or its specific function. Practitioners may focus on this term because the court's construction will determine whether the claim requires a distinct hardware component within the PAP device dedicated to remote transmission, or if the system's overall functionality can satisfy the limitation.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party might argue that the specification discloses a variety of wireless transmission schemes and that "second" is merely an ordinal descriptor in a multi-component system, not a strict requirement for a physically separate transmitter from the "first" in the cell phone, as long as the system function is met (’284 Patent, col. 8:50-63).
- Evidence for a Narrower Interpretation: Claim 1 structurally separates the "first radio frequency wireless transceiver" as a component of the "cell phone" from the "at least one second radio frequency wireless transceiver" as a component of the "PAP device" (’284 Patent, col. 24:5-6, 24:25-27). This grammatical structure supports an interpretation that they are two different components in two different devices.
"transmitted via"
- Context and Importance: The meaning of "via" is directly tied to the required data path. Plaintiff's argument for the AirMini product is that data reaching the remote site is not transmitted "via" the PAP device's transceiver but is instead relayed by the cell phone (Compl. ¶36).
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party could argue that "via" should be interpreted broadly to mean "originating from" or "by way of," which could include data that passes through an intermediary like a cell phone.
- Evidence for a Narrower Interpretation: The specification describes a "signal processing module" (analogous to the PAP device) that "transmits the signal 18 by wireless means to a base station 40" (’284 Patent, col. 9:8-11). This language could be used to support an interpretation requiring a more direct transmission path from the PAP device to the remote receiving entity.
VI. Other Allegations
- Indirect Infringement: The complaint asserts that because no direct infringement occurs, there can be no indirect infringement (induced or contributory) (Compl. ¶¶42-43).
- Willful Infringement: Willfulness is not at issue in this declaratory judgment complaint filed by the accused infringer.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of architectural mismatch: does the patent, as a matter of law, require the PAP device to contain its own distinct transceiver for transmitting data to the remote site, or can this limitation be met by a system where the PAP device's data is relayed to the remote site by the cell phone's transceiver?
- A key evidentiary question will be one of operational reality: for each accused product, what is the actual hardware configuration and data communication pathway? The outcome will depend on factual evidence establishing how data travels from the patient's device to the remote server.
- The case may also turn on a definitional scope question: can the phrase "transmitted via the at least one second radio frequency wireless transceiver" be construed to cover a data path that includes an intermediate, relaying transmitter (the cell phone) that is not part of the PAP device?