PTAB

IPR2022-01560

Apple Inc v. AliveCor Inc

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Methods and Systems for Arrhythmia Tracking and Scoring
  • Brief Description: The ’956 patent relates to methods for evaluating a user's heart health by analyzing heart rate and other physiological information received from a wearable computing device.

3. Grounds for Unpatentability

Ground 1: Obviousness over Shmueli and Almen - Claims 1, 4-5, 7, and 9-13 are obvious over Shmueli in view of Almen.

  • Prior Art Relied Upon: Shmueli (WO 2012/140559) and Almen (Patent 7,460,899).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Shmueli taught a wrist-worn heart monitoring device with photoplethysmography (PPG) and electrocardiogram (ECG) sensors. Shmueli's device continuously monitors physiological data and triggers an ECG measurement upon detecting an "intermittent irregular heart-related event." Almen taught a wrist-worn monitor that specifically analyzes heart rate variability (HRV) to detect cardiovascular conditions like arrhythmia. The proposed combination would use Almen's method of calculating an irregular HRV value from the heart rate data gathered by Shmueli's PPG sensor and would use that irregular HRV value as the trigger for initiating an ECG measurement, as taught by Shmueli.
    • Motivation to Combine: A Person of Ordinary Skill in the Art (POSITA) would combine the references to improve the functionality of Shmueli's device. Almen provided a more specific and medically recognized method (HRV analysis) for detecting the very type of "irregular heart-related event" Shmueli sought to identify. Incorporating Almen’s teachings would result in a more accurate and reliable trigger for the ECG measurement, achieving the shared goal of both references to monitor cardiac health.
    • Expectation of Success: A POSITA would have a high expectation of success because the combination merely involved implementing Almen's known HRV calculation algorithms as software on the conventional hardware (processor, memory, sensors) already disclosed in Shmueli's device.

Ground 2: Obviousness over Shmueli-Almen and Ong - Claims 2-3, 6, 8, and 14 are obvious over Shmueli and Almen in view of Ong.

  • Prior Art Relied Upon: Shmueli (WO 2012/140559), Almen (Patent 7,460,899), and Ong (Application # 2014/0257122).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground built upon the Shmueli-Almen combination. Ong taught a system for determining a cardiac risk score, or "Heart Health Score," using parameters that explicitly include HRV and ECG analysis. Petitioner argued that the Shmueli-Almen combination provided the necessary HRV and ECG data inputs, and Ong taught how to process these inputs to generate a quantitative score. This score could then be displayed on the wearable device, meeting limitations related to generating and displaying a score based on HRV and ECG data.
    • Motivation to Combine: A POSITA would be motivated to further modify the Shmueli-Almen device with Ong's teachings to provide a more useful and clinically relevant output to the user. Rather than just providing a binary alert, a risk score offers a more nuanced, easy-to-understand assessment of heart health. This would improve the device's utility for self-monitoring, a goal consistent with all three references.

Ground 3: Obviousness over Shmueli-Almen and Osorio - Claims 18-21 are obvious over Shmueli and Almen in view of Osorio.

  • Prior Art Relied Upon: Shmueli (WO 2012/140559), Almen (Patent 7,460,899), and Osorio (Application # 2014/0275840).

  • Core Argument for this Ground:

    • Prior Art Mapping: This ground also built upon the core Shmueli-Almen combination. Osorio taught a monitoring technique that improves the accuracy of arrhythmia detection by correlating HRV data with a patient's physical activity level, which is determined using an activity sensor like an accelerometer. Petitioner argued that the combination would integrate Osorio's activity monitoring into the Shmueli-Almen device, allowing it to compare a user's determined HRV value with their concurrent activity level to more accurately determine the presence of atrial fibrillation.
    • Motivation to Combine: A POSITA would combine Osorio's teaching to enhance the reliability of the underlying Shmueli-Almen device. It was well-known that heart rate and HRV are affected by physical exertion. By incorporating an activity sensor, the combined device could distinguish between pathological irregularities and normal physiological responses to exercise, thereby reducing the incidence of false positive diagnoses.
    • Expectation of Success: A POSITA would have a reasonable expectation of success in integrating an activity sensor and related software into the Shmueli-Almen device, as both were directed to body-worn medical devices and Osorio's method was a known way to improve the quality of data from such devices.

  • Additional Grounds: Petitioner asserted an additional obviousness challenge for claims 14-17 based on the combination of Shmueli, Almen, and Asl (a 2008 journal article teaching a specific support vector machine-based algorithm for arrhythmia classification using HRV signals).

4. Relief Requested

  • Petitioner requests institution of an inter partes review (IPR) and cancellation of claims 1-21 of Patent 9,420,956 as unpatentable.