DCT
3:23-cv-00500
ResMed Corp v. Cleveland Medical Devices Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: ResMed Corp. (Minnesota, with principal place of business in California)
- Defendant: Cleveland Medical Devices, Inc. (Ohio)
- Plaintiff’s Counsel: DLA Piper LLP (US)
- Case Identification: 3:23-cv-00500, S.D. Cal., 03/20/2023
- Venue Allegations: Plaintiff ResMed Corp. alleges that venue is proper in the Southern District of California because Defendant CleveMed is subject to personal jurisdiction in the district for the purposes of this action, and thus is deemed to reside there under the general venue statute applicable to declaratory judgment actions. The complaint also notes that ResMed’s principal place of business, along with relevant witnesses and evidence, are located in the district.
- 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 integrated systems for sleep disorder diagnosis and treatment.
- Technical Context: The technology concerns connected medical devices for treating sleep apnea, which use sensors and wireless communication to transmit patient data between a therapy device, a cell phone, and a remote internet site for monitoring and analysis.
- Key Procedural History: This action was filed six days after the patent-in-suit issued. The complaint states that the patent is part of a family of patents, some of which are the subject of a pending lawsuit filed by CleveMed against ResMed’s parent company, ResMed Inc., in the District of Delaware. ResMed alleges this declaratory judgment action is warranted due to an immediate threat of litigation and that the patent was drafted in an effort to cover ResMed’s products. This procedural posture suggests a preemptive filing by ResMed to secure a favorable forum.
Case Timeline
| Date | Event |
|---|---|
| 2005-11-04 | Earliest Priority Date for the ’284 Patent |
| 2018-09-18 | Issue Date for related ’269 Patent asserted in DE Action |
| 2022-06-16 | CleveMed files Delaware Action against ResMed Inc. |
| 2023-03-14 | U.S. Patent No. 11,602,284 Issues |
| 2023-03-20 | ResMed Corp. files this Complaint for Declaratory Judgment |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 11,602,284 - "Devices and Methods for Sleep Disorder Diagnosis and Treatment," Issued March 14, 2023
The Invention Explained
- Problem Addressed: The patent’s background section identifies limitations in conventional methods for diagnosing and treating sleep disorders like sleep apnea. It notes that diagnostic tests are often inconvenient and that treatment devices, such as CPAP machines, are typically static and cannot automatically adjust therapy based on a patient's real-time physiological condition or symptoms (’284 Patent, col. 1:48-2:45).
- The Patented Solution: The invention proposes an integrated system that combines diagnosis and treatment into a "closed loop system or method" (’284 Patent, col. 2:49-54). The system uses physiological sensors (e.g., airflow sensors, EEG electrodes) to diagnose or assess the severity of a patient's condition and uses that data to automatically adjust a treatment device, such as a CPAP machine, "with or without human intervention" (’284 Patent, col. 3:6-12; Fig. 8). This allows for dynamic, responsive therapy tailored to the patient's immediate needs.
- Technical Importance: The technology aims to create more effective and personalized treatments for sleep disorders by moving away from one-size-fits-all therapy pressures toward an automated, data-driven approach that responds to a patient's changing state during sleep (’284 Patent, col. 2:46-54).
Key Claims at a Glance
- The complaint’s non-infringement arguments focus on independent claim 1.
- The essential elements of independent claim 1 include:
- A "non-transitory computer readable medium" with "first software" for a cell phone to display an "index of treatment efficacy."
- A "cell phone" with a "first radio frequency wireless transceiver."
- A "PAP device" with an enclosure containing a blower, an airflow sensor, a "second processor" for calculating severity and usage data, and a "second radio frequency wireless transceiver" for transmitting that data.
- A "remote internet site" adapted to receive the data transmitted from the PAP device's "second radio frequency wireless transceiver."
- The complaint seeks a declaratory judgment of non-infringement for all claims 1-20 (’284 Patent, col. 23:57-26:43; Compl. ¶34).
III. The Accused Instrumentality
Product Identification
- The "ResMed Accused Products" include the ResMed Astral and Stellar ventilators, as well as the AirSense 10, AirCurve 10, AirSense 11, and AirMini CPAP devices (Compl. ¶7).
Functionality and Market Context
- These are described as "digital health technologies and cloud-connected medical devices" for treating sleep apnea and other chronic respiratory diseases (Compl. ¶2). The complaint alleges specific functionalities relevant to its non-infringement theory. For example, it states that the AirMini device connects and sends data directly to a cell phone via Bluetooth, and that any subsequent transmission to an internet site is performed by the cell phone, not the AirMini device itself (Compl. ¶36). It also alleges that the ResMed cell phone software applications which display treatment data do not support the Astral and Stellar ventilator products (Compl. ¶36). 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 | ResMed cell phone software applications that display treatment data allegedly do not support the Astral and Stellar products or data calculated by them. | ¶36 | col. 23:60-24:10 |
| the PAP device with an enclosure further comprising:...at least one second radio frequency wireless transceiver | The complaint alleges the ResMed Astral and Stellar ventilators do not have transceivers in an enclosure as required by the claim. | ¶36 | col. 24:11-24:17 |
| a remote internet site, the remote internet site adapted to receive the data...generated by the PAP device and transmitted via the at least one second radio frequency wireless transceiver | The complaint alleges the AirMini CPAP device does not meet this limitation because it transmits data to the cell phone (via the "first" transceiver); any data received by a remote site is transmitted by the cell phone, not from the AirMini's "second" transceiver. | ¶36 | col. 24:28-24:35 |
- Identified Points of Contention:
- Scope Questions: The dispute raises the question of whether the claimed "system" requires direct integration between all recited components. ResMed argues that because its Astral and Stellar ventilators do not interface with the specified cell phone software, they do not form part of the claimed system.
- Technical Questions: A central technical question is whether the data transmission architecture of the accused AirMini product matches the architecture required by the claim. The complaint alleges a mismatch: the claim requires the PAP device's transceiver to transmit to the remote internet site, whereas the AirMini's transceiver (Bluetooth) allegedly transmits only to the cell phone, which then relays the data. The case may turn on whether this indirect transmission path falls within the claim's scope.
V. Key Claim Terms for Construction
1. The Term: "remote internet site... adapted to receive data... transmitted via the at least one second radio frequency wireless transceiver"
- Context and Importance: This term is critical to the non-infringement argument for the AirMini product. ResMed’s position is that the AirMini’s transceiver transmits to the phone, and the phone’s transceiver transmits to the internet site. Therefore, the internet site does not receive data "via" the PAP device's ("second") transceiver. The construction of this data path is central to the dispute.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation (CleveMed's potential view): The specification describes a system where data from sensors is processed and can be relayed to a processor for analysis, potentially through various wireless means, including a "wireless router" that connects to the internet (’284 Patent, col. 8:36-43, col. 19:39-44). A party could argue this supports a more flexible interpretation of the data path, where an intermediate hop through the phone is an unstated but foreseeable implementation detail.
- Evidence for a Narrower Interpretation (ResMed's view): The plain language of claim 1 recites a specific path: data is transmitted "via" the second transceiver to the remote site. Dependent claim 3 adds the limitation that this transmission occurs "via in part by cell towers," which strongly suggests the second transceiver is a cellular modem capable of direct-to-tower communication, not a short-range protocol like Bluetooth that relies on a phone (’284 Patent, col. 24:40-48). The complaint explicitly argues the AirMini "cannot transmit data to a cell tower" (Compl. ¶38).
2. The Term: "at least one second radio frequency wireless transceiver"
- Context and Importance: Practitioners may focus on this term because its technical requirements are defined by its function in the claim. If it must be capable of transmitting to a "remote internet site," as claim 1 requires, its definition may be narrowed to exclude short-range technologies like Bluetooth that cannot do so independently.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation (CleveMed's potential view): The specification broadly refers to wireless technologies, including "Bluetooth wireless technology" (’284 Patent, col. 8:57-59). This could support an argument that any RF transceiver, including Bluetooth, meets the literal terms of the claim.
- Evidence for a Narrower Interpretation (ResMed's view): The function this transceiver must perform—transmitting data to a "remote internet site"—constrains its meaning. As argued in the complaint, a Bluetooth transceiver only transmits to a local device (the phone), not a remote internet site. The explicit mention of "cell towers" in dependent claim 3 further implies that the transceiver in the parent claim is of a type, such as cellular, capable of such communication (Compl. ¶38; ’284 Patent, col. 24:40-48).
VI. Other Allegations
- Indirect Infringement: The complaint preemptively denies indirect infringement, stating that there can be no inducement or contributory infringement because there is no underlying direct infringement of the ’284 patent's claims (Compl. ¶¶42-43). It further argues against contributory infringement by stating the accused products have substantial non-infringing uses (Compl. ¶43).
- Willful Infringement: Willfulness is not formally alleged, as this is a declaratory judgment action filed by the accused infringer. However, the complaint itself establishes pre-suit knowledge of the patent family and of CleveMed’s infringement positions through its detailed recitation of the prior Delaware litigation and communications between the parties (Compl. ¶¶15, 22-26). This history would likely form the basis of a willfulness counterclaim by CleveMed.
VII. Analyst’s Conclusion: Key Questions for the Case
This declaratory judgment action appears designed to resolve specific, targeted non-infringement arguments in a forum of the plaintiff's choosing. The case will likely depend on the court's resolution of the following questions:
- A core issue will be one of architectural equivalence: Does the accused system’s data path (PAP device → Bluetooth → Phone → Internet) satisfy the claim language requiring the PAP device's own transceiver to transmit data to a "remote internet site"? Or does this represent a fundamental technical mismatch?
- The case will also turn on a question of definitional scope: Must the claimed "second radio frequency wireless transceiver" be construed narrowly as a cellular-capable modem, based on its function of transmitting to an internet site and the mention of "cell towers" in a dependent claim? Or can the term be read broadly to cover any RF technology, including the Bluetooth transceiver used in the AirMini?
- Finally, an issue of systemic scope will be dispositive for the ventilator products: Do the claims require functional integration between the therapy device (e.g., ventilator) and the "first software" on the cell phone, such that the absence of such integration for certain products takes them outside the scope of the claimed "system"?