DCT
2:19-cv-07261
Wiesel v. Apple Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Joseph Wiesel (New York)
- Defendant: Apple Inc. (Delaware)
- Plaintiff’s Counsel: Gabriel & Pelaez, PLLC
- Case Identification: 2:19-cv-07261, E.D.N.Y., 12/27/2019
- Venue Allegations: Venue is alleged to be proper based on the Plaintiff's residence within the district and Defendant’s operation of established, regular places of business within the district.
- Core Dispute: Plaintiff alleges that the "irregular rhythm notification" feature in Defendant's Apple Watch product line infringes a patent related to methods and systems for detecting possible atrial fibrillation by analyzing pulse rate irregularity.
- Technical Context: The lawsuit concerns the field of consumer wearable health technology, specifically the use of optical sensors for automated, non-clinical screening of cardiac arrhythmias.
- Key Procedural History: The complaint alleges that Plaintiff provided Defendant with pre-suit notice of infringement, including an initial letter and subsequent claim charts, beginning in September 2017. This alleged notice pre-dates the launch of several of the accused products and forms the basis for the willfulness allegations.
Case Timeline
| Date | Event |
|---|---|
| 1999-12-20 | ’514 Patent Priority Date |
| 2006-03-28 | ’514 Patent Issue Date |
| 2016-09-16 | Apple Watch Series 1 and Series 2 Launch |
| 2017-09-20 | Alleged First Notice Letter to Defendant |
| 2017-09-22 | Apple Watch Series 3 Launch |
| 2018-12-06 | Apple Watch Series 4 Launch |
| 2019-09-20 | Apple Watch Series 5 Launch |
| 2019-12-27 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 7,020,514 - "Method of and apparatus for detecting atrial fibrillation," issued March 28, 2006
The Invention Explained
- Problem Addressed: The patent's background section identifies a need for a reliable method for laypersons to screen for atrial fibrillation (AFib) outside of a clinical setting. It notes that prior art devices for measuring pulse rate were not designed to specifically detect the "random pattern of beats found almost exclusively in atrial fibrillation" and could not reliably distinguish it from less serious arrhythmias or normal variations in heart rate (Compl. ¶12; ’514 Patent, col. 2:47-51, col. 3:33-41).
- The Patented Solution: The invention proposes a method and apparatus that automatically detects and analyzes a "succession of time intervals" between sequential pulse beats to determine if the pattern is irregular in a manner indicative of AFib (’514 Patent, Abstract). The system can acquire pulse data using technologies like a blood pressure cuff or, as depicted in Figure 2, a photoplethysmograph (PPG) that measures changes in light transmission through a body part, such as a finger (’514 Patent, col. 7:1-14). After analyzing the beat-to-beat data, the device provides an indication to the user about the possible presence of AFib (’514 Patent, col. 1:57-63).
- Technical Importance: The claimed invention addresses a shift from simple pulse counting to a more sophisticated, automated analysis of beat-to-beat timing variability, aiming to provide a specific screening tool for AFib suitable for home use (’514 Patent, col. 4:26-30).
Key Claims at a Glance
- The complaint asserts independent claims 1 (a method) and 12 (an apparatus).
- Independent Claim 1 (Method) requires the steps of:
- detecting irregular pulse rhythms from a succession of time intervals each corresponding to a respective interval of time between successive pulse beats of a sequence of the pulse beats;
- analyzing the detected irregular pulse rhythms to make a determination of possible atrial fibrillation; and
- indicating the possible atrial fibrillation from the determination.
- Independent Claim 12 (Apparatus) requires:
- a detector configured to detect irregular pulse rhythms from a succession of time intervals corresponding to intervals between successive pulse beats;
- a processor configured to analyze the detected irregular pulse rhythms for making a determination of possible atrial fibrillation; and
- an indicator configured to indicate the possible atrial fibrillation based on the determination.
- The complaint reserves the right to assert dependent claims, including claims 7, 10, 16, 17, and 18 (Compl. ¶39; Prayer for Relief ¶A).
III. The Accused Instrumentality
Product Identification
The accused instrumentalities are the Apple Watch Series 1, 2, 3, 4, and 5, and specifically their "irregular rhythm notification" feature (Compl. ¶¶19, 34).
Functionality and Market Context
The complaint alleges that the accused watches use an optical heart sensor (a form of photoplethysmograph, or PPG) to detect the user's pulse wave at the wrist (Compl. ¶¶36, 44). This sensor data is then used to measure "beat-to-beat intervals" (Compl. ¶37). An algorithm analyzes this data in the background to identify rhythms that are suggestive of AFib. If the algorithm repeatedly detects such an irregularity, the watch provides a notification to the user on its display (Compl. ¶¶44, 50). The complaint highlights the feature's importance by citing Defendant's marketing materials and an FDA submission that describes the feature's ability to "identify episodes of irregular heart rhythms consistent with atrial fibrillation" (Compl. ¶37).
IV. Analysis of Infringement Allegations
The complaint includes a visual chart comparing Apple Watch models, which indicates that Series 1 through 4 watches are equipped with an "Optical heart sensor / PPG" and are capable of providing an "Irregular Rhythm Notification" (Compl. p. 12).
’514 Patent Infringement Allegations (Method Claim 1)
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| (a) detecting irregular pulse rhythms from a succession of time intervals each corresponding to a respective interval of time between successive pulse beats... | Defendant's marketing materials allegedly state the Apple Watch uses its optical sensor to "look for variability in beat-to-beat intervals" and its FDA submission describes measuring "beat-to-beat intervals." | ¶¶37, 44 | col. 1:57-63 |
| (b) analyzing the detected irregular pulse rhythms to make a determination of possible atrial fibrillation | The Apple Watch allegedly uses an algorithm that "repeatedly detects an irregular rhythm suggestive of AFib" and classifies tachograms "to determine if an irregular rhythm may be present." | ¶¶44, 51 | col. 6:44-50 |
| (c) indicating the possible atrial fibrillation from the determination | The Apple Watch is alleged to "send... a notification if it detects an irregular rhythm that appears to be atrial fibrillation" and to "alert you to these irregularities." | ¶¶35, 50 | col. 6:31-35 |
’514 Patent Infringement Allegations (Apparatus Claim 12)
| Claim Element (from Independent Claim 12) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a detector configured to detect irregular pulse rhythms from a succession of time intervals... | The Apple Watch allegedly includes an "optical heart sensor" (PPG) that uses "green LED lights paired with light-sensitive photodiodes to detect the amount of blood flowing through your wrist." | ¶¶36, 48, 51 | col. 8:33-37 |
| a processor configured to analyze the detected irregular pulse rhythms for making a determination of possible atrial fibrillation | The processor in the Apple Watch, which allegedly includes an ASIC, runs "underlying algorithms" to classify heart rhythms based on sensor data to determine if an irregularity is present. | ¶¶51, 53 | col. 6:24-28 |
| an indicator configured to indicate the possible atrial fibrillation based on the determination | The Apple Watch display is allegedly used to show notifications that indicate irregular rhythms. | ¶52 | col. 8:40-45 |
Identified Points of Contention
- Scope Questions: A primary issue may be whether the claim term "analyzing the detected irregular pulse rhythms" is limited to the specific statistical algorithm described in the patent's detailed description (calculating the quotient of the standard deviation over the mean) or if it covers the broader concept of any algorithmic analysis of beat-to-beat intervals used to screen for AFib.
- Technical Questions: The complaint relies on high-level marketing statements and FDA documents to describe the accused functionality. A key evidentiary question will be whether the specific, proprietary algorithm used by Apple actually performs the analysis in a manner that meets the limitations of the claims, as they are ultimately construed by the court.
V. Key Claim Terms for Construction
The Term: "analyzing the detected irregular pulse rhythms"
Context and Importance: This term is the central functional step of the invention. The scope of this term will be critical to the infringement analysis, as it defines the required data processing. Practitioners may focus on this term because the patent discloses a very specific mathematical method for analysis, which could be used to argue for a narrow claim construction.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The plain language of claims 1 and 12 does not specify a particular method of analysis. The abstract similarly uses the general term "analyzing" without further limitation (’514 Patent, Abstract).
- Evidence for a Narrower Interpretation: The specification describes a specific embodiment in which "The mean and standard deviation of these last ten beats was calculated and the quotient of the standard deviation over the mean was determined. This was compared to a threshold value of 0.06" (’514 Patent, col. 6:44-50). A party could argue this detailed disclosure defines and limits the scope of "analyzing."
The Term: "a succession of time intervals"
Context and Importance: This term defines the input data for the "analyzing" step. Its construction will determine what sequence of measurements is required by the claims.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The plain language of the independent claims suggests any sequence of beat-to-beat time intervals could suffice.
- Evidence for a Narrower Interpretation: The specification discloses analyzing "only the last ten beats" and excluding initial beats to compensate for respiratory variation (’514 Patent, col. 6:44-45; col. 8:14-17). This could support an argument that the claimed "succession" must have certain characteristics or be processed in a particular way.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that Defendant induces infringement by providing support materials, marketing, and instructions that encourage and direct Apple Watch users to utilize the accused irregular rhythm notification feature (Compl. ¶¶16, 44, 48).
- Willful Infringement: The complaint alleges that Defendant had actual knowledge of the ’514 Patent since at least September 20, 2017, as a result of a notice letter and subsequent communications that included detailed claim charts (Compl. ¶¶20-22). The complaint further alleges that Defendant continued to infringe, including by launching the Apple Watch Series 4 and 5 after receiving this notice, demonstrating willful and deliberate conduct (Compl. ¶24).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of claim construction: can the term "analyzing", as taught in the patent, be interpreted broadly to encompass any algorithm that assesses beat-to-beat variability for AFib detection, or will it be confined to the specific statistical method (standard deviation over mean compared to a threshold) disclosed in the patent’s only detailed example? The outcome of this question will likely dictate the infringement analysis.
- A second central question will be one of willfulness: given the specific allegations that Plaintiff provided Defendant with pre-suit notice and claim charts well before the launch of the Apple Watch Series 4 and 5, the case may turn on whether Defendant's continued development and sale of products with the accused feature constitutes objective recklessness, which could expose it to enhanced damages.