Apple Inc v. AliveCor Inc

1. Case Identification

• Case #: IPR2022-01562
• Patent #: 10,159,415
• Filed: September 26, 2022
• Petitioner(s): Apple Inc.
• Challenged Claims: 1-20

2. Patent Overview

• Title: METHODS AND SYSTEMS FOR ARRHYTHMIA TRACKING AND SCORING
• Brief Description: The ’415 patent relates to methods and systems for evaluating a user's heart health by analyzing heart rate data received from a wearable computing device to detect cardiac conditions, including arrhythmia and atrial fibrillation.

3. Grounds for Unpatentability

Ground 1: Obviousness over Shmueli and Almen - Claims 1-2 and 11-12 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 device with a photoplethysmography (PPG) sensor for continuously monitoring a user and an electrocardiogram (ECG) sensor. Upon detecting an "intermittent irregular heart-related event" from the PPG data, Shmueli's device triggered an ECG measurement. Petitioner contended that Almen taught a similar wrist-worn device that specifically used heart rate variability (HRV) analysis, derived from sensor data, to detect cardiovascular conditions like arrhythmia. The combination allegedly met the independent claim limitations by using Shmueli’s hardware framework and replacing its general irregularity detection with Almen’s more specific and well-known HRV analysis to trigger the ECG. Dependent claim 2, requiring a wristband, was allegedly taught by the form factor of both references.
  • Motivation to Combine: A POSITA would combine the references to improve the functionality of Shmueli’s device. Almen explicitly taught that HRV analysis was an effective method for detecting arrhythmias. Incorporating Almen's specific HRV-based detection into Shmueli's system, which already aimed to detect irregularities and trigger an ECG, was presented as a predictable and logical improvement to achieve the shared goal of both references: monitoring heart health.
  • Expectation of Success: A POSITA would have had a high expectation of success because both references described similar wrist-worn devices using comparable hardware (e.g., optical sensors, processors). Implementing Almen's HRV algorithms was characterized as a routine software modification on the hardware platform disclosed by Shmueli.

Ground 2: Obviousness over Shmueli, Almen, and Osorio - Claims 3-7 and 13-17 are obvious over Shmueli and Almen in further 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 built upon the Shmueli-Almen combination from Ground 1. Petitioner argued that Osorio addressed the problem of false positives in arrhythmia detection by teaching the use of an activity sensor (e.g., an accelerometer) to contextualize HRV data. Osorio disclosed determining a non-pathological HRV range that dynamically adjusts based on the user's current activity level (e.g., sleeping, walking, running). An arrhythmia is detected only when the user's current HRV falls outside this activity-adjusted range. This combination allegedly met the limitations of claims 5 and 15, which required sensing an activity level with a motion sensor and comparing the HRV to that activity level.
  • Motivation to Combine: A POSITA would be motivated to add Osorio’s teachings to the Shmueli-Almen combination to improve accuracy and reduce false alarms. It was well-known that physical activity affects heart rate. Osorio's method of using activity level to create dynamic, non-pathological thresholds for HRV offered a clear solution to distinguish between normal heart rate changes due to exercise and pathological arrhythmias, thereby making the base device more reliable.
  • Expectation of Success: The expectation of success was argued to be high. Incorporating an accelerometer and the associated software logic from Osorio into a wearable device like that of Shmueli-Almen was a straightforward and well-understood integration for a POSITA.

Ground 3: Obviousness over Shmueli, Almen, and Asl - Claims 8-10 and 18-20 are obvious over Shmueli and Almen in further view of Asl.

• Prior Art Relied Upon: Shmueli (WO 2012/140559), Almen (Patent 7,460,899), and Asl (a 2008 journal article titled "Support vector machine-based arrhythmia classification using reduced features of heart rate variability signal").
• Core Argument for this Ground:
  • Prior Art Mapping: This ground also built upon the Shmueli-Almen combination. Petitioner asserted that Asl taught using a machine learning algorithm, specifically a support vector machine, to analyze HRV data and classify different types of arrhythmias, including atrial fibrillation. The combination of Shmueli-Almen with Asl allegedly rendered claims 8 and 18 obvious by teaching the use of a machine learning algorithm to determine the presence of an arrhythmia. Claims 9-10 and 19-20, which involved training the algorithm on historical user data, were allegedly made obvious by Asl’s disclosure of training its algorithm on arrhythmia databases.
  • Motivation to Combine: The motivation was to enhance the diagnostic capability of the Shmueli-Almen device. While the base combination could detect an irregularity, Asl provided a known machine-learning-based method to not just detect but also classify the specific type of arrhythmia. This would provide more clinically useful information, a clear goal for such a monitoring device.
  • Expectation of Success: A POSITA would have expected success in implementing Asl's algorithm. Asl's method used HRV data as its input, which was the same data already being generated and analyzed in the Shmueli-Almen combination. Implementing Asl’s algorithm was presented as a software-level task that was well within the ordinary skill in the art.

4. Key Claim Construction Positions

• "irregular heart condition": Petitioner argued that a POSITA would have understood the claim term "irregular heart condition," which is not a standard medical term, to refer to "arrhythmia." This interpretation was allegedly supported by the context of the prior art (Shmueli), which used the term in the context of detecting irregularities with PPG sensors and confirming them with an ECG, a standard diagnostic tool for arrhythmias.

5. Relief Requested

• Petitioner requests institution of an inter partes review and cancellation of claims 1-20 of the ’415 patent as unpatentable.