PTAB

IPR2021-00972

Apple Inc v. AliveCor Inc

Log In
Key Events
Petition
petition Intelligence

1. Case Identification

2. Patent Overview

  • Title: DISCORDANCE MONITORING
  • Brief Description: The ’941 patent relates to a cardiac monitoring system, such as a smartwatch, that detects potential arrhythmia. The system senses a user's heart rate parameter and activity level and determines if a "discordance" exists between the two values, such as an elevated heart rate during a period of rest, to indicate a possible arrhythmia.

3. Grounds for Unpatentability

Ground 1: Claims 1, 5, 7-9, 11, 12, 16, 18-20, 22, and 23 are obvious over Shmueli in view of Osorio.

  • Prior Art Relied Upon: Shmueli (WO 2012/140559) and Osorio (Application # 2014/0275840).
  • Core Argument for this Ground:
    • Prior Art Mapping: Shmueli disclosed a wrist-worn device that continuously monitors for an irregular heart condition using a PPG sensor (oximetry) and, upon detection, prompts the user to take a confirmatory ECG measurement. Osorio disclosed improving arrhythmia detection by monitoring a user's activity level with a motion sensor and comparing heart rate variability (HRV) against established non-pathological ranges that vary with activity (e.g., distinct ranges for sleeping, resting, and walking). The combination teaches all elements of independent claims 1 and 12, including sensing activity, sensing a heart rate parameter, and determining a "discordance" when the measured heart rate parameter falls outside the expected, activity-specific range.
    • Motivation to Combine: A POSITA would combine Osorio’s activity-based analysis with Shmueli’s device to improve accuracy and reduce false positives. Shmueli's PPG-based detection did not account for activity level, a well-known variable affecting heart rate, and Osorio explicitly taught using activity level to avoid "false diagnoses" in arrhythmia detection.
    • Expectation of Success: A POSITA would have a high expectation of success, as the combination involved integrating a known component (an activity sensor) and a known analysis technique (activity-level-dependent thresholds) into a known device type (a wrist-worn cardiac monitor) to achieve a predictable improvement in reliability.

Ground 2: Claims 2-4, 6, 13-15, and 17 are obvious over Shmueli in view of Osorio and Lee-2013.

  • Prior Art Relied Upon: Shmueli (WO 2012/140559), Osorio (Application # 2014/0275840), and Lee-2013 (a 2013 article in the International Journal of Bioelectromagnetism).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground builds on the Shmueli-Osorio combination. Lee-2013 taught using specific statistical methods (e.g., Root Mean Square of Successive Differences) to analyze PPG data from a mobile device to detect atrial fibrillation (AF). This teaching supplies the limitation in dependent claims requiring the detected arrhythmia to be AF.
    • Motivation to Combine: The base Shmueli-Osorio combination detected general arrhythmias. A POSITA would be motivated to add Lee-2013's specific AF detection method to provide a more precise diagnosis, particularly since AF is the most common type of sustained arrhythmia. This modification would add significant clinical value to the base device.
    • Expectation of Success: Success was predictable as it involved applying Lee-2013's known software-based analysis to the PPG data already being collected by the Shmueli-Osorio device.

Ground 3: Claims 10 and 21 are obvious over Shmueli in view of Osorio and Chan.

  • Prior Art Relied Upon: Shmueli (WO 2012/140559), Osorio (Application # 2014/0275840), and Chan (Patent 7,894,888).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground also builds on the Shmueli-Osorio combination. While Shmueli’s device included a display, it provided no detail on how ECG results should be presented. Chan disclosed a wristwatch device that displays a real-time "ECG rhythm strip" on its screen. This directly maps to the claim limitation requiring the display of such a strip.
    • Motivation to Combine: A POSITA would look to prior art for methods of displaying the ECG data collected by the Shmueli-Osorio device. Chan provided a finite, well-known, and logical solution: displaying the ECG waveform as a rhythm strip, allowing the user to view the measurement in real-time.
    • Expectation of Success: Success would be expected, as it involved incorporating a known display feature from one wrist-worn cardiac monitor (Chan) into a similar device (Shmueli-Osorio) to provide necessary user feedback.

4. Key Claim Construction Positions

  • "Discordance" (Claims 1, 12): Petitioner argued this term should be construed as "when a first sensed parameter value would not be expected to coincide with a second sensed parameter value." This construction, taken directly from the ’941 patent’s specification, supports the argument that a heart rate value falling outside an activity-level-dependent normal range (taught by Osorio) constitutes a discordance.

5. Arguments Regarding Discretionary Denial

  • Petitioner presented extensive arguments that discretionary denial under the Fintiv factors would be inappropriate.
  • Factor 1 (Stays): The related district court case is already stayed pending an ITC investigation, and Petitioner intends to move for a stay in the ITC upon IPR institution.
  • Factor 2 (Timing): The petition was filed very early, before the ITC target date was set, and the IPR’s Final Written Decision is expected to issue around the same time as the ITC’s final determination, weighing against denial.
  • Factor 3 (Investment): The parallel proceedings are in their infancy, with minimal investment of time and resources by the parties or the court.
  • Factor 4 (Overlap): Petitioner stipulated it would not pursue invalidity in the parallel proceedings based on any ground utilizing Shmueli, Osorio, Lee-2013, or Chan, creating "zero overlap" between the IPR and other proceedings.
  • Factors 5 & 6 (Other): The parties are the same, making Factor 5 neutral. The Board has not previously considered these grounds, and the IPR provides the unique remedy of claim cancellation, favoring institution.

6. Relief Requested

  • Petitioner requests institution of an inter partes review and cancellation of claims 1-23 of the ’941 patent as unpatentable.