DCT

1:22-cv-00794

Cleveland Medical Devices Inc v. ResMed Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:22-cv-00794, D. Del., 06/16/2022
  • Venue Allegations: Venue is alleged as proper in the District of Delaware because Defendant ResMed Inc. is a Delaware corporation.
  • Core Dispute: Plaintiff alleges that Defendant’s sleep apnea diagnostic and treatment products, including its ApneaLink home sleep testing devices and AirSense positive airway pressure devices, infringe a portfolio of eight U.S. patents related to remote sleep disorder diagnosis and therapy.
  • Technical Context: The technology concerns systems and methods for conducting sleep studies outside of a traditional laboratory, enabling at-home diagnosis and remote monitoring and adjustment of therapy for conditions like obstructive sleep apnea.
  • Key Procedural History: The complaint alleges a history of pre-suit interactions, including meetings between the parties starting in 2017 to discuss potential partnerships, during which Plaintiff allegedly provided Defendant with an overview of its patented technology. The complaint further alleges that Plaintiff provided Defendant with specific notice of U.S. Patent No. 10,076,269 in 2018 and U.S. Patent Nos. 10,426,399 and 10,478,118 in November 2019, which forms the basis for the allegations of willful infringement.

Case Timeline

Date Event
2005-11-04 Priority Date for U.S. Patent No. 10,076,269
2007-06-08 Priority Date for seven asserted patents ('399', '535', '937', '698', '118', '603', '637')
2016-Early ResMed acquires Brightree
2017-Starting Plaintiff and Defendant allegedly begin meetings to discuss technology and patents
2018-07-24 U.S. Patent No. 10,028,698 Issues
2018-09-04 Earliest alleged date of Defendant's knowledge of the '269' Patent
2018-09-18 U.S. Patent No. 10,076,269 Issues
2019-10-01 U.S. Patent No. 10,426,399 Issues
2019-11-19 U.S. Patent No. 10,478,118 Issues
2019-November Defendant allegedly receives notice of '399 and '118 Patents
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 Complaint Filed

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 10,076,269 - Devices and Methods for Sleep Disorder Diagnosis and Treatment

The Invention Explained

  • Problem Addressed: The patent addresses the limitations of existing sleep apnea treatments, noting that available devices could not adjust a patient's therapy based on their current physiological state or symptoms as they occurred. (’269 Patent, col. 2:27-34).
  • The Patented Solution: The invention is a sleep disorder treatment system that integrates a therapeutic device, such as a positive airway pressure (PAP) machine, with diagnostic sensors like an airflow sensor and a pulse oximeter. (’269 Patent, col. 3:5-24). A processor analyzes sensor data to calculate the severity of sleep disorder symptoms, and a wireless transceiver transmits this data to a separate device, such as a cellular phone, which can then display the data and retransmit it to a remote site, enabling potential adjustment of the therapy device. (Compl. ¶¶ 34-35; ’269 Patent, col. 4:1-17).
  • Technical Importance: This approach enables near real-time monitoring and remote adjustment of sleep apnea therapy based on a patient's actual physiological condition during sleep, aiming to improve treatment efficacy and compliance. (Compl. ¶¶ 35-36).

Key Claims at a Glance

  • The complaint asserts at least independent claim 15. (Compl. ¶ 81).
  • The essential elements of Claim 15, a system claim, include:
    • A Positive Airway Pressure (PAP) device with a blower and an internal airflow sensor.
    • A processor for receiving airflow sensor data and calculating symptom severity data.
    • A first radio frequency wireless module transceiver.
    • A base station, cellular phone, or PDA comprising a second wireless transceiver, a processor, software, and a display.
    • The base station, cellular phone, or PDA is adapted to display the symptom data and retransmit it to a remote internet site.
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 10,426,399 - Method and Device for In-Home Sleep and Signal Analysis

The Invention Explained

  • Problem Addressed: The patent background describes the significant cost, inconvenience, and potential for inaccurate results (due to the "first night effect") associated with traditional, lab-based polysomnography (PSG) tests for diagnosing sleep disorders. (’399 Patent, col. 1:60-2:2).
  • The Patented Solution: The invention is a method for conducting sleep tests at home. It involves providing a patient with a portable, wearable interface box equipped with sensors such as a nasal cannula (airflow), a respiratory effort belt, and a fingertip pulse oximeter. (’399 Patent, Abstract). The interface box measures and collects physiological data while the subject sleeps at home, digitizes it, stores it in nonvolatile memory, and the data is later transferred to a remote location for analysis by a computer or processor to identify events indicative of a sleeping disorder. (Compl. ¶¶ 17, 39-40; ’399 Patent, col. 4:45-53).
  • Technical Importance: This method allows for more convenient, cost-effective, and potentially more accurate diagnosis of sleep disorders by enabling data collection in the patient's natural home environment. (Compl. ¶¶ 40, 42).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1. (Compl. ¶ 108).
  • The essential elements of Claim 1, a method claim, include:
    • Providing a subject with a portable patient interface box and associated sensors (nasal cannula, respiratory effort belt, pulse oximeter).
    • Applying and connecting the sensors and interface box to the subject.
    • Measuring and collecting data from the sensors while the subject sleeps at home.
    • Digitizing and storing the collected data in the interface box's memory.
    • Transferring the data to a location remote from the subject's home.
    • Providing a computer or processor at the remote location to analyze the data and identify physiological or technological events.
  • The complaint does not explicitly reserve the right to assert dependent claims.

Multi-Patent Capsules

  • Patent Identification: U.S. Patent No. 10,925,535, Method and Device for In-Home Sleep and Signal Analysis, issued February 23, 2021.

  • Technology Synopsis: The patent describes a system for at-home sleep testing that includes a portable interface box worn on the torso, connecting to at least three sensors (e.g., nasal cannula, respiratory effort belt, pulse oximeter) and a kinetic sensor. (Compl. ¶ 19). The system includes a remote database for receiving collected data, which is then analyzed to identify physiological or technological events indicative of a sleeping disorder. (Compl. ¶ 145-146).

  • Asserted Claims: At least Claim 15 (independent). (Compl. ¶ 138).

  • Accused Features: The Accused HST Solution, including the ApneaLink Air device, ApneaLink Software, and/or AirView platform. (Compl. ¶ 141).

  • Patent Identification: U.S. Patent No. 11,064,937, Method and Device for In-Home Sleep and Signal Analysis, issued July 20, 2021.

  • Technology Synopsis: The patent discloses a system for remote sleep testing using a portable interface box connected to a nasal cannula, a respiratory effort belt, and a pulse oximeter. (Compl. ¶ 21). The system features a processor for digitizing and storing data, a remote database for receiving the data, and software for analyzing the data to identify events indicative of a sleeping disorder. (Compl. ¶ 21).

  • Asserted Claims: At least Claim 1 (independent). (Compl. ¶ 165).

  • Accused Features: The Accused HST Solution, including the ApneaLink Air device, ApneaLink Software, and/or AirView platform. (Compl. ¶ 168).

  • Patent Identification: U.S. Patent No. 10,028,698, Method and Device for Sleep Analysis, issued July 24, 2018.

  • Technology Synopsis: The patent is directed to methods for remote sleep analysis and diagnosis. (Compl. ¶ 23). The method involves applying at least two sensors to a subject that connect to an interface box, which collects and transmits data to medical personnel at a remote location for analysis and diagnosis. (’698 Patent, Abstract).

  • Asserted Claims: At least Claim 14 (independent). (Compl. ¶ 194).

  • Accused Features: The Accused HST Solution, including the ApneaLink Air device, ApneaLink Software, and/or AirView platform. (Compl. ¶ 197).

  • Patent Identification: U.S. Patent No. 10,478,118, Method and Device for Sleep Analysis, issued November 19, 2019.

  • Technology Synopsis: The patent discloses methods of remote sleep analysis using a portable interface box with a nasal cannula, respiratory effort belt, and pulse oximeter. (Compl. ¶ 25). The collected physiological data is digitized, stored, and sent to a remote lab or database for analysis to determine if the subject has a sleeping disorder. (Compl. ¶ 25).

  • Asserted Claims: At least Claim 1 (independent). (Compl. ¶ 225).

  • Accused Features: The Accused HST Solution, including the ApneaLink Air device, ApneaLink Software, and/or AirView platform. (Compl. ¶ 228).

  • Patent Identification: U.S. Patent No. 11,202,603, Method and Device for Sleep Analysis, issued December 21, 2021.

  • Technology Synopsis: The patent describes sleep diagnostic systems and methods using sensors to measure a subject's airflow, respiratory effort, and blood oxygenation. (Compl. ¶ 27). The collected data is analyzed for a medical professional. (Compl. ¶ 27).

  • Asserted Claims: At least Claim 1 (independent). (Compl. ¶ 256).

  • Accused Features: The Accused HST Solution, including the ApneaLink Air device, ApneaLink Software, and/or AirView platform. (Compl. ¶ 259).

  • Patent Identification: U.S. Patent No. 11,234,637, Method and Device for In-Home Sleep and Signal Analysis, issued February 1, 2022.

  • Technology Synopsis: The patent discloses systems for conducting home sleep analysis using devices to obtain airflow, respiratory effort, blood oxygenation, and body position data. (Compl. ¶ 29). The system can transmit the data and includes software that identifies events indicative of a sleeping disorder. (Compl. ¶ 29).

  • Asserted Claims: At least Claim 1 (independent). (Compl. ¶ 287).

  • Accused Features: The Accused HST Solution, including the ApneaLink Air device, ApneaLink Software, and/or AirView platform. (Compl. ¶ 290).

III. The Accused Instrumentality

Product Identification

The complaint accuses two categories of products: ResMed’s Positive Airway Pressure (PAP) Solution and its Home Sleep Testing (HST) Solution. (Compl. ¶ 43).

Functionality and Market Context

  • The Accused PAP Solution comprises PAP devices (e.g., AirSense 10, AirSense 11, AirMini), associated user applications (e.g., myAir App), and cloud-based data management platforms (e.g., AirView, ResScan). (Compl. ¶¶ 44, 49). These devices deliver pressurized air to patients and are equipped with sensors to measure airflow and pressure, memory for data storage, and transceivers (cellular or Bluetooth) to transmit therapy and usage data. (Compl. ¶¶ 50-51). The system calculates clinical indices such as the Apnea-Hypopnea Index (AHI) and transmits this data to platforms like AirView and the myAir App, where it can be analyzed and viewed by clinicians and patients. (Compl. ¶¶ 53-57). The complaint provides a screenshot of the myAir application on a smartphone displaying a "myAir score," usage hours, and "events per hour." (Compl. p. 19).
  • The Accused HST Solution consists of the ApneaLink Air device, ApneaLink Software, and the AirView cloud platform. (Compl. ¶ 59). The ApneaLink Air is a portable device worn on the patient's torso and connects to a nasal cannula, a respiratory effort belt, and a pulse oximeter to record physiological data during sleep at home. (Compl. ¶¶ 60-61). The complaint includes a diagram of the "ApneaLink Air Complete Kit," showing the device and its associated sensors. (Compl. p. 22). Collected data is transferred from the device via USB to a computer running ApneaLink Software or is sent to the AirView cloud platform, where software automatically analyzes the data to generate reports with diagnostic indicators like AHI. (Compl. ¶¶ 66-69).

IV. Analysis of Infringement Allegations

U.S. Patent No. 10,076,269 Infringement Allegations

Claim Element (from Independent Claim 15) Alleged Infringing Functionality Complaint Citation Patent Citation
A positive airway pressure (PAP) sleep disorder treatment system, comprising: a PAP device with an enclosure further comprising: a blower having an air output; The Accused PAP Devices (e.g., AirSense 10/11) consist of a device with a blower that generates pressurized air. ¶85 col. 7:46-50
an airflow sensor internal to the PAP device adapted for measuring the respiratory airflow of a subject while using the PAP and outputting airflow sensor data; Accused PAP Devices contain internal flow and pressure sensors to measure the user's respiratory airflow. ¶85 col. 7:51-54
a processor adapted for receiving the airflow sensor data, and calculating both symptom data of a severity of the subject's sleep disorder symptoms and/or an index of a subject's symptoms measured during use of the PAP device and data of usage of the PAP device; The Accused PAP Devices have internal and external processors that receive sensor data and calculate indices of symptom severity, such as the AHI, and usage data. ¶88 col. 7:55-62
a mask or a nasal cannula; The Accused PAP Devices are used with a mask or nasal cannula. ¶85 col. 3:9-11
a first radio frequency wireless module transceiver; The Accused PAP Devices contain transceivers for wireless data transmission, such as cellular and Bluetooth modules. ¶87 col. 4:1-3
and a base station, cellular phone, or PDA; the base station, cellular phone, or PDA comprising a second radio frequency wireless module transceiver, a processor, a software, and a display... The Accused PAP Devices send data to cellular phones or PDAs running ResMed's software (e.g., myAir App), which contain transceivers, processors, and displays. ¶¶89-90 col. 4:3-6
...the base station, cellular phone, or PDA adapted to display the symptom data...and to retransmit the...symptom data...to a remote internet site using the wireless transceiver of the base station, cellular phone, or PDA. The cellular phones/PDAs running ResMed's software are alleged to display the symptom data (e.g., AHI) and retransmit it to remote internet sites like AirView. ¶90 col. 4:6-12
  • Identified Points of Contention:
    • Scope Questions: A central issue may be whether the claimed "system" requires a single, integrated apparatus or if it can be met by a distributed collection of disconnected products owned and operated by different entities (i.e., ResMed's PAP device, the patient's personal smartphone, and ResMed's remote cloud server). The construction of "base station, cellular phone, or PDA" will be critical, specifically whether its claimed functions (display and retransmission to an internet site) must be performed by a single one of those devices as a standalone component of the system.

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 by the subject 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 device, which is a portable interface box worn on the torso, along with a kit including a nasal cannula, respiratory effort belt, and pulse oximeter. ¶113 col. 28:5-13
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 for users to apply and connect the sensors and wear the ApneaLink Air device on their torso. ¶115 col. 28:22-26
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 device is used to measure and collect data on airflow, respiratory effort, body position, and oxygenation while the user sleeps at home. ¶116 col. 28:27-32
digitizing and storing the collected data from the subject in the nonvolatile digital memory of the patient interface box; The ApneaLink Air device digitizes the collected data and stores it in its internal nonvolatile memory. ¶117 col. 28:33-36
transferring the collected data to a location remote from the subject's home; The data is transferred from the ApneaLink Air device, via USB or upload to the AirView cloud, to a remote location for analysis. ¶118 col. 28:37-38
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... The ApneaLink Software and AirView platform run on computers/processors at a remote location to analyze the data and identify sleep disorder events. The complaint provides an example of a report generated by this analysis. (Compl. p. 28). ¶119 col. 28:39-44
  • Identified Points of Contention:
    • Technical Questions: A potential point of contention is the step of "transferring the collected data to a location remote from the subject's home." The complaint alleges this is satisfied by downloading data via USB to a computer. (Compl. ¶¶ 66, 118). It raises the question of whether a computer located inside the subject's home qualifies as a "location remote from the subject's home" as contemplated by the patent.

V. Key Claim Terms for Construction

  • The Term: "base station, cellular phone, or PDA" (from '269 Patent, Claim 15)

  • Context and Importance: The definition of this element is critical because the infringement theory for the PAP Solution relies on mapping this term to a combination of a patient's own smartphone running an app and/or a remote cloud-based platform like AirView. Practitioners may focus on this term because its construction will determine whether ResMed's distributed, multi-component, multi-user architecture can satisfy a limitation that may have been intended to describe a more localized, integrated device.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent's use of the disjunctive "or" suggests these are alternative, non-limiting examples of communication devices that can receive, display, and retransmit data. (’269 Patent, col. 4:3-6). The specification describes the base station as potentially being a "personal computer" which contains software to program the interface box. (’269 Patent, col. 24:55-60).
    • Evidence for a Narrower Interpretation: The claim requires the same "base station, cellular phone, or PDA" to perform multiple functions: receiving data via its transceiver, displaying it, and retransmitting it to an internet site using its own transceiver. This language may support a narrower reading where a single, discrete device must perform all recited functions, potentially creating a mismatch with an architecture where a phone displays data but the retransmission to the ultimate internet site (AirView) occurs via a separate network path.

  • The Term: "location remote from the subject's home" (from '399 Patent, Claim 1)

  • Context and Importance: This term is central to the method claims asserted against the HST Solution. The infringement allegation appears to rely on data transfer to a local computer within the home to satisfy this step. Practitioners may focus on this term because its definition will determine whether the claim requires data to be transmitted outside the physical premises of the home (e.g., to a clinical server) or merely away from the wearable device itself.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent may not explicitly define the term, which could allow for an interpretation where "remote from the subject's home" simply means not physically on the subject's person or part of the portable testing apparatus.
    • Evidence for a Narrower Interpretation: The patent's background contrasts at-home data collection with analysis performed at a traditional sleep lab. (’399 Patent, col. 1:11-37). This context suggests "remote location" was intended to mean a clinical facility or server physically separate from the residence where the test occurs.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that ResMed induces infringement by instructing and encouraging customers, clinicians, and partners to use the Accused Products in an infringing manner. (Compl. ¶ 79). This encouragement is allegedly provided through user manuals, training materials, software interfaces (e.g., AirView, myAir App), marketing, and advertising. (Compl. ¶¶ 97-98, 127-128). The complaint also alleges contributory infringement, stating that ResMed's software and devices are material components of the claimed inventions and are not staple articles suitable for substantial non-infringing use. (Compl. ¶¶ 99, 129).
  • Willful Infringement: The complaint alleges willful infringement based on Defendant's alleged pre-suit knowledge of the asserted patents. (Compl. ¶¶ 76-77). The basis for this knowledge includes a series of meetings beginning in 2017 where the parties allegedly discussed Plaintiff's patent portfolio, and specific written and verbal notices regarding the '269, '399, and '118 patents provided in 2018 and 2019. (Compl. ¶¶ 71-74, 92, 122).

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

  • A core issue will be one of system architecture: can Plaintiff prove that Defendant's multi-part, cloud-based PAP Solution—which combines a device sold by Defendant, a patient's personal smartphone, and a remote server—constitutes a single infringing "system" as defined by the claims of the '269 Patent, or is there a fundamental mismatch in how the claimed and accused systems are constructed and operate?
  • A key question of claim scope will arise for the HST patents: does the term "location remote from the subject's home" require data to be transmitted to a server or facility physically outside the patient's residence, or can this limitation be met, as alleged, by downloading the data to a local personal computer that is also located within the patient's home?
  • A central factual dispute will concern willfulness: given the detailed allegations of a multi-year business relationship involving discussions of the patented technology and specific notices of asserted patents, the court will need to determine the extent of Defendant's pre-suit knowledge and whether its continued sales of the Accused Products rose to the level of willful infringement.