ResMed Corp v. Cleveland Medical Devices Inc

Prosecution History analysis

Examiner Search analysis

Invalidity Framework analysis

Petition

Petition Analysis

## 1. Case Identification
- Case Number: [IPR2025-00246](https://ai-lab.exparte.com/case/ptab/IPR2025-00246)
- Patent #: [11,857,333](https://ai-lab.exparte.com/patent/11857333)
- Filed: January 10, 2025
- Petitioner(s): [ResMed Corp](https://ai-lab.exparte.com/party/resmed-corp).
- Patent Owner(s): [Cleveland Medical Devices, Inc](https://ai-lab.exparte.com/party/cleveland-medical-devices-inc).
- Challenged Claims: 15-29

## 2. Patent Overview
- Title: Method of Treating a Subject's Sleep Apnea
- Brief Description: The [’333](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1001) patent discloses methods for treating sleep apnea using a Positive Airway Pressure (PAP) or Continuous Positive Airway Pressure (CPAP) device. The system involves collecting physiological data from integrated sensors, analyzing it to determine a quantified level of severity, and transmitting the data to a remote station and/or a cellular phone for further analysis and therapy adjustment.

## 3. Grounds for Unpatentability

#### Ground 1: Obviousness over Toge and Kumar - Claims 15-17, 20-24, and 26-29 are obvious over Toge in view of Kumar.
- **Prior Art Relied Upon:** Japan Patent Application # [P2002-291889A](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1044) ([Toge](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1044)), Application # [2002/0198473](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1008) ([Kumar](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1008)).
- **Core Argument for this Ground:**
  - **Prior Art Mapping:** Petitioner asserted that [Toge](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1044), a telemedicine system for treating sleep apnea, discloses the core elements of independent claim 15. [Toge](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1044) teaches a PAP device with an integrated processor and sensors (flow meter, pressure gauge) that collects data during therapy, analyzes it to determine a quantified level of severity (e.g., tidal volume), and transmits this data to a mobile terminal (cellular phone) and a physician-side computer (a remote station). Petitioner argued that [Kumar](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1008), a network-based physiological monitoring system, explicitly teaches the use of a browser-based engine on a central server as a "remote station" for receiving, storing, and analyzing patient data from a patient-side device.
  - **Motivation to Combine:** A Person of Ordinary Skill in the Art (POSITA) would combine [Toge](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1044) and [Kumar](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1008) to implement a more robust remote monitoring feature. [Kumar](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1008)’s browser-based remote station would enable the PAP device in [Toge](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1044) to wirelessly transmit treatment data for beneficial purposes taught by [Kumar](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1008), such as creating a secure data backup, allowing later analysis, integrating data into electronic medical records, and enabling expert consultation on difficult cases.
  - **Expectation of Success:** A POSITA would have a reasonable expectation of success because [Kumar](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1008) expressly states that "virtually any device may be easily incorporated into the system." The combination involved integrating known wireless communication and data storage methods with a known type of PAP device to achieve the predictable result of a networked system with enhanced data access and analysis capabilities.

#### Ground 2: Obviousness over Toge, Kumar, and Norman - Claims 15-18, 20-24, and 25-29 are obvious over the combination of Toge, Kumar, and Norman.
- **Prior Art Relied Upon:** [Toge](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1044), [Kumar](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1008), and Application # [2005/0268912](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1059) ([Norman](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1059)).
- **Core Argument for this Ground:**
  - **Prior Art Mapping:** To the extent the [Toge](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1044)-[Kumar](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1008) combination does not fully render the claims obvious, Petitioner argued that [Norman](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1059) supplies the remaining limitations. [Norman](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1059) discloses an improved CPAP system with "automated titration" that analyzes airflow data to detect respiratory events (apnea, hypopnea) and automatically adjusts therapy pressure. Petitioner contended that [Norman](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1059)’s method of analyzing counts and indexes of respiratory events to determine the efficacy of administered pressure teaches the "quantified level of severity data" (limitation 15.c) and "therapy efficacy data" (limitation 15.e.1) limitations. [Norman](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1059) also teaches collecting data over multiple nights to create a "rich data set" (claim 18) and determining "total sleep time" (claim 25).
  - **Motivation to Combine:** A POSITA would be motivated to incorporate [Norman](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1059)’s automated titration into the [Toge](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1044)-[Kumar](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1008) system to improve the accuracy and efficacy of the CPAP therapy. This would enhance the system’s ability to evaluate the effectiveness of pressure adjustments and improve patient compliance and satisfaction, which are explicit goals of [Norman](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1059).
  - **Expectation of Success:** Success was expected because [Norman](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1059) teaches its features can be implemented in "any variety of PAP systems." Combining [Norman](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1059)'s known automated titration algorithms with the networked PAP device of [Toge](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1044)-[Kumar](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1008) was a predictable integration of known technologies to improve treatment efficacy.

#### Ground 3: Obviousness over Toge, Kumar, and Burton - Claim 19 is obvious over the combination of Toge, Kumar, and Burton.
- **Prior Art Relied Upon:** [Toge](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1044), [Kumar](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1008), and WIPO Publication # [WO2004032719A2](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1050) ([Burton](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1050)).
- **Core Argument for this Ground:**
  - **Prior Art Mapping:** Claim 19 depends on claim 15 and adds the step of training the PAP device to "identify and distinguish between obstructive, central and complex sleep apneas." Petitioner argued that [Burton](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1050) discloses an adaptive algorithm for PAP devices that does precisely this. [Burton](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1050) teaches using an adaptive algorithm to modify therapy based on detecting and distinguishing between various sleep apnea events, including obstructive, central, and mixed (i.e., complex) apneas, to improve sleep quality by avoiding transient arousals.
  - **Motivation to Combine:** A POSITA would be motivated to implement [Burton](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1050)'s adaptive algorithm into the [Toge](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1044)-[Kumar](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1008) networked device to improve the accuracy of diagnosis and treatment. This would allow the device to be customized for a patient's specific condition, minimizing sleep fragmentation and enhancing the therapeutic benefit, a key goal taught by [Burton](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1050).
  - **Expectation of Success:** [Burton](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1050)'s features are explicitly "adapted for use with a CPAP machine," and the invention is described as "easily adapted for use with, or incorporated within, other known therapeutic devices." Therefore, a POSITA would have reasonably expected success in integrating [Burton](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1050)'s known self-learning algorithm into the processor of the [Toge](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1044)-[Kumar](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1008) device to achieve a more sophisticated, self-adjusting therapy system.

- **Additional Grounds:** Petitioner asserted an additional obviousness challenge against claim 19 based on the combination of [Toge](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1044), [Kumar](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1008), [Norman](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1059), and [Burton](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1050), leveraging the combined teachings of all references.

## 4. Key Claim Construction Positions
- For the purposes of the petition, Petitioner adopted the Patent Owner's proposed constructions from a parallel district court litigation for two key terms:
  - **"transmitting"** (limitation 15.d): Petitioner proceeded under the Patent Owner's interpretation.
  - **"therapy efficacy data"** (limitation 15.e.1): Petitioner adopted the Patent Owner's proposed meaning of data calculated to determine the severity of symptoms and whether the PAP device needs adjustment.
- Petitioner noted this adoption was for the purpose of the IPR proceeding only and did not concede the correctness of the constructions.

## 5. Arguments Regarding Discretionary Denial
- Petitioner argued that the Board should not exercise discretionary denial.
  - **§325(d) (Advanced Bionics):** Denial is inappropriate because the primary references ([Toge](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1044), [Kumar](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1008), [Norman](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1059), [Burton](https://ai-lab.exparte.com/case/ptab/IPR2025-00246/doc/1050)) and the specific combinations argued in the petition were never presented to or considered by the USPTO during the original prosecution.
  - **§314(a) (Fintiv):** Denial under *Fintiv* is inapplicable because, at the time of filing the petition, no trial date was scheduled in the parallel district court litigation.

## 6. Relief Requested
- Petitioner requests the institution of an *inter partes* review and the cancellation of claims 15-29 of Patent [11,857,333](https://ai-lab.exparte.com/patent/11857333) as unpatentable.

ResMed challenges sleep apnea patent with 3 obviousness grounds: Toge & Kumar cited against 15 claims for remote CPAP monitoring & data analysis.