DCT

2:23-cv-00141

Research Foundation for State University Of New York v. Samsung Electronics Co Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:23-cv-00141, E.D. Tex., 04/03/2023
  • Venue Allegations: Venue is alleged to be proper based on Defendants having regular and established places of business within the Eastern District of Texas, committing acts of infringement in the district, and, for foreign defendant Samsung Electronics Co., Ltd., under 28 U.S.C. § 1391(c)(3).
  • Core Dispute: Plaintiffs allege that Defendant’s Samsung Galaxy smartwatches infringe nine U.S. patents related to algorithms for monitoring physiological functions, including methods for detecting atrial fibrillation and for detecting and removing motion artifacts from biomedical sensor data.
  • Technical Context: The technology at issue involves signal processing for wearable health monitoring devices, a rapidly growing consumer electronics market focused on providing users with real-time health data.
  • Key Procedural History: The complaint alleges a prior working relationship between the named inventor, Dr. Ki Chon, and Samsung from 2015 to 2018, during which Samsung was allegedly given access to Dr. Chon's research, data, and patented algorithms. Communication reportedly ceased in 2018, and Samsung subsequently launched its first watches with atrial fibrillation detection capabilities in September 2020. This history forms the primary basis for Plaintiffs' allegations of willful infringement.

Case Timeline

Date Event
2007-08-02 U.S. Patent No. 8,417,326 Priority Date
2010-10-12 U.S. Patent No. 8,718,753 Priority Date
2011-01-21 U.S. Patent No. 9,713,428 Priority Date
2013-04-09 U.S. Patent No. 8,417,326 Issued
2013-05-01 U.S. Patent No. 9,408,576 Priority Date
2014-05-01 U.S. Patent No. 9,986,921 & 10,285,601 Priority Date
2014-05-06 U.S. Patent No. 8,718,753 Issued
2015-01-29 U.S. Patent No. 10,653,362 Priority Date
2015-06-09 U.S. Patent No. 9,872,652 & 10,278,647 Priority Date
2015-06 Dr. Chon meets with Samsung representative
2016 - 2018 Dr. Chon and Samsung collaborate on research
2016-08-09 U.S. Patent No. 9,408,576 Issued
2017-07-25 U.S. Patent No. 9,713,428 Issued
2018-01-23 U.S. Patent No. 9,872,652 Issued
2018-06-05 U.S. Patent No. 9,986,921 Issued
2018 Communication between Dr. Chon and Samsung ceases
2019-05-07 U.S. Patent No. 10,278,647 Issued
2019-05-14 U.S. Patent No. 10,285,601 Issued
2020-05-19 U.S. Patent No. 10,653,362 Issued
2020-09 Samsung releases Health Monitor app with AF detection for Galaxy Watch3 and Active2
2023-04-03 Complaint Filed

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 8,417,326 - “RR Interval Monitoring Method and Blood Pressure Cuff Utilizing Same”

The Invention Explained

  • Problem Addressed: The patent addresses the need for an ambulatory, real-time method for detecting Atrial Fibrillation (AF) (Compl. ¶36). A key limitation of prior methods was the need to use large databases of training data to achieve accurate AF detection (Compl. ¶127).
  • The Patented Solution: The invention is a method that analyzes heart beat intervals using a combination of three distinct statistical techniques: Turning Points Ratio (TPR), Root Mean Square of Successive Differences (RMSSD), and Shannon Entropy (SE) (’326 Patent, col. 2:54-62; Compl. ¶114). This combination of metrics is alleged to allow for accurate AF detection without the need for training data (Compl. ¶127).
  • Technical Importance: The claimed approach purports to enable accurate, real-time AF detection in ambulatory devices by combining statistical techniques that do not require prior training data, which could improve the efficiency and accessibility of such monitoring (Compl. ¶127).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1 (Compl. ¶110).
  • Essential elements of independent claim 1 include:
    • An Atrial Fibrillation (AF) analysis method comprising:
    • obtaining an output that includes a heart beat;
    • deriving a heart beat interval;
    • analyzing a number (N) of heart beat intervals from the output; and
    • detecting a likelihood of AF by: calculating a Turning Points Ratio (TPR), calculating a root mean square of successive (RMSSD) heart beat intervals, and calculating Shannon Entropy (SE) of the N heart beat intervals.
  • The complaint reserves the right to assert additional claims (Compl. ¶134).

Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
An Atrial Fibrillation (AF) analysis method comprising: obtaining an output that includes a heart beat; The Accused Watches' ECG App obtains a recording of the heart's electrical activity, which includes heart beats. ¶116 col. 4:55-58
deriving a heart beat interval; The Accused Watches use the ECG recording to determine heart rate and analyze heart rhythm. This necessarily involves deriving heart beat intervals. ¶117 col. 4:55-58
analyzing a number (N) of heart beat intervals from the output; and The algorithm used by the Accused Watches analyzes the derived heart beat intervals to determine the presence of AF. ¶118 col. 4:59-60
detecting a likelihood of AF by: calculating a Turning Points Ratio (TPR) of the N heart beat intervals; calculating a root mean square of successive (RMSSD) heart beat intervals; and calculating Shannon Entropy (SE) of the N heart beat intervals. The complaint alleges on information and belief that the algorithm used by the Accused Watches detects AF by performing these specific three calculations (TPR, RMSSD, and SE). The complaint provides a screenshot from a Samsung document showing that the ECG app can classify a recording as "Atrial Fibrillation (AFib)". ¶119, ¶115, p. 22 col. 4:61-67
  • Identified Points of Contention:
    • Technical Questions: A central question will be evidentiary: what proof demonstrates that the Accused Watches' proprietary software performs the specific three-part statistical analysis (TPR, RMSSD, and SE) required by claim 1? The complaint alleges this on "information and belief" and supports it with marketing materials showing the device can detect "Atrial Fibrillation," which is the output of the claimed method, not a direct description of the method itself (Compl. ¶119, p. 22).
    • Scope Questions: Does the "output that includes a heart beat" as described in the patent, which was filed in 2007 in the context of ECGs and blood pressure cuffs, read on the specific type of sensor data generated by the Accused Watches' "BioActive Sensor" which combines optical heart rate, electrical heart signal, and bioelectrical impedance analysis sensors? (Compl. p. 23).

U.S. Patent No. 8,718,753 - “Motion and Noise Artifact Detection for ECG Data”

The Invention Explained

  • Problem Addressed: The patent describes the problem of motion and noise (MN) artifacts corrupting electrocardiogram (ECG) signals, which can reduce the accuracy of identifying cardiac conditions like paroxysmal atrial fibrillation (AF) (Compl. ¶43). Prior art methods could result in distortions leading to incorrect classifications (Compl. ¶156).
  • The Patented Solution: The invention provides a method for detecting these artifacts by receiving an ECG segment and mathematically decomposing it into a sum of "intrinsic mode functions." By isolating the functions associated with motion and noise, and then comparing their "randomness and variability characteristic values" to a threshold, the method determines if the original ECG segment is corrupted by motion artifacts (’753 Patent, col. 2:25-45; Compl. ¶141).
  • Technical Importance: This technology aims to improve the accuracy of AF detection in ECG signals by providing a real-time method to identify and account for signal distortions caused by user movement (Compl. ¶156).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1 (Compl. ¶137).
  • Essential elements of independent claim 1 include:
    • A method for detecting motion and noise artifacts in an electrocardiogram (ECG) recording, comprising:
    • receiving an ECG segment;
    • decomposing the received ECG segment into a sum of intrinsic mode functions;
    • isolating intrinsic mode functions associated with motion and noise artifacts present within the ECG segment;
    • determining randomness and variability characteristic values associated with the isolated intrinsic mode functions;
    • comparing the randomness and variability characteristic values to threshold values; and
    • determining that the received ECG segment includes motion and noise artifacts if the characteristic values exceed the threshold values.
  • The complaint reserves the right to assert additional claims (Compl. ¶163).

Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for detecting motion and noise artifacts in an electrocardiogram (ECG) recording, comprising: receiving an ECG segment; The Accused Watches' ECG App is used to "record an ECG" for analysis. ¶143 col. 2:25-28
decomposing the received ECG segment into a sum of intrinsic mode functions; The complaint alleges on information and belief that the algorithm performs this specific mathematical decomposition. ¶144 col. 2:29-31
isolating intrinsic mode functions associated with motion and noise artifacts present within the ECG segment; The complaint alleges on information and belief that the algorithm isolates the specific functions associated with motion. The complaint provides a screenshot showing the watches can detect "unnecessary movements as exercise". ¶145, p. 48 col. 2:32-34
determining randomness and variability characteristic values associated with the isolated intrinsic mode functions; The complaint alleges on information and belief that the algorithm determines these characteristic values. ¶146 col. 2:35-37
comparing the randomness and variability characteristic values to threshold...values; and The complaint alleges on information and belief that the algorithm performs this comparison. ¶147 col. 2:38-40
determining that the received ECG segment includes motion and noise artifacts if the...values exceed the threshold...values. The complaint alleges on information and belief that the algorithm makes this determination, pointing to user guidance that instructs users to "not move your arms or talk" to avoid "inaccurate or no ECG results." ¶148, p. 42 col. 2:40-45
  • Identified Points of Contention:
    • Technical Questions: What evidence shows that Samsung's general-purpose motion detection features (e.g., for workout detection or for ensuring a clean ECG reading) employ the specific, mathematically-defined process of "decomposing" a signal into "intrinsic mode functions" and isolating them as claimed?
    • Scope Questions: Can the term "isolating intrinsic mode functions associated with motion and noise artifacts" be construed to cover a system that provides general user guidance like "You do not move your arms or talk" to improve signal quality, or does the claim require a specific internal software process of mathematical isolation and analysis? (Compl. p. 42).

Multi-Patent Capsules

  • U.S. Patent No. 9,408,576: Titled “Detection and Monitoring of Atrial Fibrillation,” issued August 9, 2016. This patent is directed to an algorithm for discriminating between different types of heart rhythms, including normal sinus rhythm (NSR), AF, premature ventricular contractions (PVC), and premature atrial contractions (PAC) (Compl. ¶50). It asserts at least claim 1 (Compl. ¶166). The complaint alleges the Accused Watches use this method to discriminate between AF, PVC, and PACs (Compl. ¶171).
  • U.S. Patent No. 9,713,428: Titled “Physiological Parameter Monitoring with a Mobile Communication Device,” issued July 25, 2017. This patent describes systems and methods for physiological monitoring that detect motion artifacts to ensure reported results are of acceptable quality (Compl. ¶56). It asserts at least claim 1 (Compl. ¶199). The Accused Watches are alleged to perform physiological parameter monitoring and detect motion artifacts using this method (Compl. ¶204, ¶207).
  • U.S. Patent No. 9,872,652: Titled “Method and Apparatus for Heart Rate Monitoring Using an Electrocardiogram Sensor,” issued January 23, 2018. The patent is directed to a method that uses a time-varying spectral analysis to reconstruct an ECG signal that includes motion artifacts (Compl. ¶62). It asserts at least claim 1 (Compl. ¶229). The Accused Watches are alleged to reconstruct a heart-related signal from a biomedical sensor by pre-processing the signal and using a time-varying spectral analysis (Compl. ¶234-236).
  • U.S. Patent No. 9,986,921: Titled “Detection and Monitoring of Atrial Fibrillation,” issued June 5, 2018. This patent discloses a method for real-time arrhythmia discrimination in smartphones by analyzing pulsatile time series collected from the device's camera to distinguish between NSR, AF, PACs, and PVCs (Compl. ¶68). It asserts at least claim 1 (Compl. ¶256). The Accused Watches are alleged to utilize this method for real-time arrhythmia discrimination (Compl. ¶264).
  • U.S. Patent No. 10,278,647: Titled “Method and Apparatus for Removing Motion Artifacts from Biomedical Signals,” issued May 7, 2019. This patent describes a method for reconstructing a heart-related signal containing motion artifacts by using a time-varying spectral analysis of both the heart-related signal and a motion signal from a motion sensor (Compl. ¶74, ¶285). It asserts at least claim 1 (Compl. ¶281). The complaint alleges the Accused Watches use this method to reconstruct a heart-related signal by analyzing both the signal itself and a motion signal (Compl. ¶287).
  • U.S. Patent No. 10,285,601: Titled “Detection and Monitoring of Atrial Fibrillation,” issued May 14, 2019. This patent is directed to a system for discriminating between normal sinus rhythm and various arrhythmias (AF, PVC, PAC) using processors configured to obtain and compare statistical metrics like RMSSD, Shannon entropy, and turning point ratio to predetermined thresholds (Compl. ¶80, ¶311). It asserts at least claim 1 (Compl. ¶307). The Accused Watches are alleged to contain processors that perform this discrimination (Compl. ¶312, ¶313).
  • U.S. Patent No. 10,653,362: Titled “Motion and Noise Artifact Detection and Reconstruction Algorithms for Photoplethysmogram and Equivalent Signals,” issued May 19, 2020. This patent is directed to a pulse oximeter with a motion and noise artifact detection algorithm based on extracting time-varying spectral features (Compl. ¶86). It asserts at least claim 1 (Compl. ¶336). The Accused Watches are alleged to use this method for physiological parameter monitoring using a PPG signal (Compl. ¶341, ¶354).

III. The Accused Instrumentality

Product Identification

  • The accused products are the Samsung Galaxy Watch3, Galaxy Watch4, Galaxy Watch4 Classic, Galaxy Watch5, Galaxy Watch5 Pro, and Galaxy Watch Active2 devices (collectively, the "Accused Watches") (Compl. ¶111). The Samsung Health Monitor application is also identified as incorporating the infringing technology (Compl. ¶113).

Functionality and Market Context

  • The Accused Watches are smartwatches that can, among other things, "analyze your exercise pattern, manage your health and allows you to use a variety of convenient apps" (Compl. ¶90). A key feature is their function as a "personal health coach," which includes measuring heart rate with photodiode sensors, monitoring sleep, and checking stress levels (Compl. ¶91-92). The complaint highlights the ECG monitoring capability, enabled by the Samsung Health Monitor app, which "detects ECG signals...and determines whether atrial fibrillation or normal sinus rhythm is present" (Compl. ¶120). A diagram from a Samsung user manual shows the location of the heart rate sensor on the back of the watch (Compl. p. 18).

IV. Key Claim Terms for Construction

For the ’326 Patent:

  • The Term: "detecting a likelihood of AF by: calculating a Turning Points Ratio (TPR)...calculating a root mean square of successive (RMSSD)...and calculating Shannon Entropy (SE)"
  • Context and Importance: This term defines the core of the claimed invention. The infringement analysis will turn on whether Samsung's algorithm performs all three of these specific statistical calculations to detect AF. Practitioners may focus on this term because it requires proof of a specific multi-step method, not just a result.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent specification describes the invention as providing "an overall accuracy that refers to detection of AF, irrespective of the duration of AF and beat-to-beat classification" (’326 Patent, Abstract), which may suggest the focus is on the accurate detection outcome rather than a rigid sequence of calculations.
    • Evidence for a Narrower Interpretation: The claim language uses the conjunctive "and," suggesting that all three calculations (TPR, RMSSD, SE) are required steps of the method. The summary of the invention explicitly lists the combination of these three metrics as the basis for AF detection (’326 Patent, col. 2:54-62).

For the ’753 Patent:

  • The Term: "decomposing the received ECG segment into a sum of intrinsic mode functions"
  • Context and Importance: This is a highly technical term of art that describes a specific signal processing technique (Empirical Mode Decomposition). The central infringement question is whether Samsung's method for handling motion artifacts performs this specific decomposition. Practitioners may focus on this term because it appears to claim a precise mathematical process, which Plaintiffs must prove the accused products perform.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent's background describes the general problem of MN artifacts and the need for techniques to "separate clean ECG portions from segments with MN artifacts" (’753 Patent, col. 1:49-52). This broader problem statement could be used to argue that the claims cover various methods of signal separation.
    • Evidence for a Narrower Interpretation: The detailed description specifically defines "intrinsic mode functions" and outlines a multi-step process for decomposition (’753 Patent, col. 3:20-56). The claims repeatedly use this precise term, suggesting it is a critical limitation and not merely an exemplary embodiment.

V. Other Allegations

  • Indirect Infringement: The complaint alleges that Samsung induces infringement by marketing, advertising, and promoting the Accused Watches, and by providing user manuals that instruct end-users on how to use the infringing functionalities, such as the Samsung Health Monitor app to monitor physiological parameters (Compl. ¶133, ¶162).
  • Willful Infringement: The complaint alleges willful infringement based on Samsung's alleged pre-suit knowledge of the patented technology. This knowledge is alleged to have been gained through a multi-year (2015-2018) collaboration with the inventor, Dr. Chon, during which Samsung was allegedly provided access to his data, proprietary algorithms, and was made aware of his intent to file patents. The complaint alleges that after this collaboration ended, Samsung launched products with the same AF detection capabilities (Compl. ¶94-108, ¶122-123).

VI. Analyst’s Conclusion: Key Questions for the Case

  • A core issue will be one of evidentiary proof: Can Plaintiffs produce evidence, likely through discovery and reverse engineering, to demonstrate that the algorithms in Samsung’s "black box" software perform the specific, multi-step mathematical processes recited in the asserted claims (e.g., the combined TPR, RMSSD, and SE analysis of the ’326 patent, or the decomposition into "intrinsic mode functions" of the ’753 patent)? The dispute may hinge on whether Samsung's general health-monitoring functions map directly onto these claimed technical methods.
  • A second central question relates to knowledge and intent: How will the detailed history of collaboration between the inventor and Samsung, including alleged sharing of proprietary data and algorithms, impact the determination of willful infringement? The court will need to examine the extent of Samsung's knowledge derived from this relationship and its potential influence on the development of the Accused Watches after the collaboration ceased.