ResMed Corp v. Cleveland Medical Devices Inc

1. Case Identification

• Case #: IPR2025-00246
• Patent #: 11,857,333
• Filed: January 10, 2025
• Petitioner(s): ResMed Corp.
• Patent Owner(s): Cleveland Medical Devices, Inc.
• Challenged Claims: 15-29

2. Patent Overview

• Title: Method of Treating Sleep Apnea
• Brief Description: The ’333 patent describes a networked system for treating sleep apnea where a Positive Airway Pressure (PAP) or Continuous Positive Airway Pressure (CPAP) device collects physiological data from a subject, analyzes it, and transmits the data to a cellular phone and a remote station for further analysis and review by a clinician.

3. Grounds for Unpatentability

Ground 1: Claims 15-17, 20-24, and 26-29 are obvious over Toge in view of Kumar.

• Prior Art Relied Upon: Toge (Japan Patent Application Pub. No. P2002-291889A) and Kumar (Application # 2002/0198473).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Toge disclosed a remote telemedicine system for treating sleep apnea using a PAP device with an integrated processor and sensors (flow meter, pressure gauge). Toge’s system collects data, such as tidal volume (a "quantified level of severity"), and transmits it via a network to a physician’s computer ("remote station") or mobile terminal ("cellular phone"). Petitioner contended that Kumar supplied the teaching of a browser-based, network-accessible remote engine for storing, replaying, and analyzing physiological data. The combination of Toge’s PAP system with Kumar’s remote data management engine was alleged to render the core data collection, analysis, and transmission steps of independent claim 15 obvious.
  • Motivation to Combine: A POSITA would combine Kumar’s remote monitoring and secured storage features with Toge’s PAP system to gain significant benefits. These included creating a secure data backup, enabling later access for detailed analysis or expert consultation on difficult cases, and tracking patient data trends over time, all of which were known goals in telemedicine.
  • Expectation of Success: Petitioner asserted a POSITA would have had an expectation of success because Kumar expressly taught that its system could easily incorporate "virtually any device." The combination involved integrating known wireless communication and data management technologies with a standard PAP device to achieve the predictable result of a remotely monitored sleep apnea therapy system.

Ground 2: Claims 15-18, 20-24, and 25-29 are obvious over Toge in view of Kumar and Norman.

• Prior Art Relied Upon: Toge, Kumar, and Norman (Application # 2005/0268912).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground augmented the Toge/Kumar combination with Norman to address specific limitations related to automated therapy adjustment. Petitioner argued that Norman disclosed a CPAP system with an "automatic titration device" that analyzes airflow data to detect respiratory events (apnea, hypopnea) and determine their counts or indexes. This analysis was used to indicate the "efficacy of the pressure administered" and automatically adjust therapy, thereby teaching the limitations of determining "therapy efficacy data" (claim 15.e.1) and a more detailed "quantified level of severity data" (claim 15.c). Norman’s teaching of collecting data over multiple nights to enhance accuracy was asserted to render claim 18 ("rich data set") obvious.
  • Motivation to Combine: A POSITA would be motivated to add Norman’s automated titration method to the Toge/Kumar system to improve the accuracy and efficacy of the CPAP treatment. This would enhance the system’s ability to tailor therapy to a patient's specific, changing needs, thereby improving patient compliance and satisfaction—a well-understood goal in the field.
  • Expectation of Success: Norman taught that its automated titration features could be implemented in "any variety of PAP systems." Therefore, a POSITA would have reasonably expected to successfully integrate Norman's analytical and titration logic into the processor of the Toge/Kumar system to create a more advanced, adaptive therapy device.

Ground 3: Claim 19 is obvious over Toge in view of Kumar and Burton.

• Prior Art Relied Upon: Toge, Kumar, and Burton (WO 2004/032719A2).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground challenged dependent claim 19, which required the method to "identify and distinguish between obstructive, central and complex sleep apneas." Petitioner argued that Burton disclosed an adaptive algorithm for PAP therapy specifically designed to address this. Burton’s system used various data inputs to identify different types of apnea events and automatically adjust therapy based on indices for "Mixed Sleep Apnea events," "Central Sleep Apnea events," and "Obstructive sleep apnea," directly teaching the claimed limitation.
  • Motivation to Combine: A POSITA would incorporate Burton's sophisticated diagnostic algorithm into the Toge/Kumar base system to provide more accurate and effective treatment. By distinguishing between apnea types, the system could avoid improper pressure changes that cause transient arousals, thereby improving the patient's overall sleep quality, a primary objective of sleep apnea therapy.
  • Expectation of Success: Burton stated its features were "adapted for use with a CPAP machine" and could be "easily adapted for use with, or incorporated within, other known therapeutic devices." This express teaching, combined with the predictable nature of implementing software algorithms on a processor, would have provided a POSITA with a high expectation of success.
• Additional Grounds: Petitioner asserted a fourth ground that claim 19 is obvious over the combination of Toge, Kumar, Norman, and Burton, relying on similar reasoning for combining the references.

4. Key Claim Construction Positions

• For the purposes of the IPR proceeding, Petitioner adopted the Patent Owner's proposed constructions from parallel district court litigation for the key terms "transmitting" (as recited in limitation 15.d) and "therapy efficacy data" (as recited in limitation 15.e.1), while reserving the right to argue alternative constructions in other proceedings.

5. Arguments Regarding Discretionary Denial

• Petitioner argued that discretionary denial under §325(d) would be inappropriate because the primary prior art references (Toge, Kumar, Norman, and Burton) and the combinations thereof were never presented to or considered by the USPTO during the original prosecution.
• Petitioner also asserted that denial under the Fintiv factors was inapplicable at the time of filing, as there was no trial scheduled in the parallel district court litigation.

6. Relief Requested

• Petitioner requested institution of an inter partes review and cancellation of claims 15-29 of the ’333 patent as unpatentable under 35 U.S.C. §103.