Apple Inc v. Wiesel Joseph

1. Case Identification

• Case #: IPR2020-01540
• Patent #: 7,020,514
• Filed: September 10, 2020
• Petitioner(s): Apple Inc.
• Patent Owner(s): Wiesel
• Challenged Claims: 1-10 and 12-21

2. Patent Overview

• Title: Method and Apparatus for Detecting Atrial Fibrillation
• Brief Description: The ’514 patent relates to a method and apparatus for determining possible atrial fibrillation. The technology involves detecting a sequence of pulse beats, determining if the time intervals between these beats vary irregularly, and evaluating these irregular pulse rhythms to identify possible atrial fibrillation.

3. Grounds for Unpatentability

Ground 1: Claims 1, 5, 6, 10, 12, 14, 15, 17, and 18 are anticipated by or obvious over Forstner.

• Prior Art Relied Upon: Forstner (Patent 6,485,429).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Forstner disclosed all limitations of the challenged claims. Forstner described a method for simultaneously measuring blood pressure and detecting arrhythmia by analyzing "pulse time differences." It detected irregular pulse rhythms by evaluating these differences against a histogram (as shown in its Figure 6) and explicitly taught that a "high degree of variation... might be caused by atrial fibrillation." Petitioner asserted this met the independent claim limitations of detecting irregular pulse rhythms from a succession of time intervals and analyzing them to determine possible atrial fibrillation. The apparatus claims were met by Forstner’s disclosure of a device with a cuff (detector), a "signal processing unit" (processor), and indication means like "signal lamps, LEDs or an LCD display" (indicator).
  • Key Aspects: Petitioner contended that Forstner’s direct statement linking a high degree of pulse variation to potential atrial fibrillation satisfied the claim requirement of making a "determination of possible atrial fibrillation," even if other arrhythmias were also detectable.

Ground 2: Claims 2-4, 8, 13, 19, and 20 are obvious over Forstner in view of Meijler.

• Prior Art Relied Upon: Forstner (Patent 6,485,429) and Meijler (a 1997 publication titled "Role of the Atrioventricular Node in Atrial Fibrillation").
• Core Argument for this Ground:
  • Prior Art Mapping: This ground built upon Forstner by adding a specific quantitative analysis for irregularity. Petitioner argued Meijler taught quantifying the degree of ventricular rhythm irregularity in atrial fibrillation patients using a "coefficient of variation" (CV), defined as the ratio of the standard deviation to the average cycle length (SD/CL). The combination of Forstner's system for measuring pulse time intervals with Meijler's CV calculation allegedly rendered obvious the dependent claims requiring analysis based on ascertaining a mean and standard deviation of time intervals and using a "quotient" (the CV) compared against a threshold.
  • Motivation to Combine: A POSITA would combine Meijler’s quantitative CV metric with Forstner’s arrhythmia detection system to improve its accuracy and provide a more robust, numerical basis for detecting atrial fibrillation, rather than relying solely on a qualitative histogram comparison. Meijler addressed the same problem of characterizing irregularity associated with atrial fibrillation.
  • Expectation of Success: Petitioner argued a POSITA would have a high expectation of success, as calculating a CV is a standard statistical operation that could be readily applied to the pulse time difference data already collected by Forstner's device. The underlying data types (time intervals between cardiac events) were analogous.

Ground 3: Claims 1, 5-7, 10, 12, and 14-18 are obvious over Amano in view of Wilkinson.

• Prior Art Relied Upon: Amano (Patent 6,095,984) and Wilkinson (a 1924 article in The British Medical Journal).

• Core Argument for this Ground:

  • Prior Art Mapping: Petitioner asserted this combination taught the invention using an alternative set of primary references. Amano disclosed a general-purpose "arrhythmia detection apparatus" that detected irregular changes in a pulse waveform but did not specifically identify atrial fibrillation. Wilkinson, a foundational clinical reference, taught that atrial fibrillation is characterized by a pulse that is "irregular in force as well as in time." Amano’s device, which measured pulse waveform changes, inherently detected variations in both amplitude (force) and interval (time).
  • Motivation to Combine: A POSITA would have been motivated to apply the well-established clinical knowledge from Wilkinson to Amano’s general arrhythmia detector to enhance its diagnostic specificity for atrial fibrillation, one of the most common arrhythmias. Detecting this specific condition would improve the device's utility. Both references shared a motivation to provide a simpler diagnostic tool that avoided the complexity of ECGs.
  • Expectation of Success: Success was expected because the combination involved applying known diagnostic criteria (from Wilkinson) to data already being captured by Amano's apparatus. A POSITA would recognize that the irregular waveforms in Amano's figures were characteristic of the atrial fibrillation described by Wilkinson.

• Additional Grounds: Petitioner asserted additional obviousness challenges, including combinations incorporating Van Den Burg (a 1997 journal article) to provide specific CV threshold values for distinguishing between healthy and atrial fibrillation patient groups, and Peel (Patent 5,931,790) to teach the use of an alternative sensor, such as an oximeter, for detecting pulse waves. These were applied to both the Forstner-based and Amano-based primary combinations.

4. Arguments Regarding Discretionary Denial

• Petitioner argued that discretionary denial under Fintiv would be inappropriate. The core reasons asserted were that the parallel district court case was at a very early stage with no trial date set, institution would likely trigger a stay and simplify issues for the court, and Petitioner stipulated it would not pursue the same invalidity grounds in district court, thus avoiding duplicative efforts. Furthermore, the petition challenged a broader set of claims than those asserted in the litigation, and the merits of the unpatentability grounds were presented as being particularly strong.

5. Relief Requested

• Petitioner requested institution of an inter partes review and cancellation of claims 1-10 and 12-21 of the ’514 patent as unpatentable.