DCT

2:26-cv-00470

Omni MedSci Inc v. Fossil Group Inc

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Amended Complaint
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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:24-cv-01070, E.D. Tex., 06/12/2026
  • Venue Allegations: Venue for foreign defendants (Samsung Electronics, Co. Ltd., OnePlus, and Õura) is alleged under 28 U.S.C. § 1391(c)(3). Venue for domestic defendants (Samsung Electronics America, Fossil) is alleged under 28 U.S.C. § 1400(b) based on their purported regular and established places of business and product sales within the Eastern District of Texas.
  • Core Dispute: Plaintiff alleges that Defendants' wearable smart devices (smartwatches and smart rings), along with associated smartphones, applications, and cloud services, infringe seven patents related to the non-invasive optical measurement of physiological parameters.
  • Technical Context: The lawsuit concerns the core technology of modern consumer health wearables, which use light-based sensors to measure biological markers such as heart rate and blood oxygen levels, and then process and display this data through a connected ecosystem.
  • Key Procedural History: The complaint alleges extensive pre-suit knowledge of the asserted technology and patents by Samsung, stemming from a series of meetings between Plaintiff's principal, Dr. Islam, and various Samsung executives and managers from 2017 to 2023. Notice is also alleged against Õura through its own patenting activities. Plaintiff alleges notice for all defendants at least upon service of the original or amended complaints in this action.

Case Timeline

Date Event
2010-01-01 Omni MedSci founded by Dr. Islam
2012-12-31 Earliest priority date for '868, '533, '484, '304, '455, '790, and '475 Patents
2015-06-16 U.S. Patent No. 9,055,868 issues
2017-04-10 Dr. Islam allegedly meets with Samsung SDS President, discusses '868 Patent
2017-05-16 U.S. Patent No. 9,651,533 issues
2017-07-17 Dr. Islam allegedly meets with Samsung Senior Manager, discusses '868 and '533 Patents
2019-12-31 U.S. Patent No. 10,517,484 issues
2020-12-29 U.S. Patent No. 10,874,304 issues
2021-08-26 Dr. Islam allegedly meets with Samsung automotive division manager, discusses '533, '484, '304 Patents
2021-10-22 Dr. Islam allegedly meets with Samsung managers, discusses '484 and '304 Patents
2021-11-02 U.S. Patent No. 11,160,455 issues
2023-03-02 Dr. Islam allegedly meets with Samsung manager, discusses '533, '484, '304, '455 Patents
2025-01-14 U.S. Patent No. 12,193,790 issues
2025-04-08 U.S. Patent No. 12,268,475 issues
2025-05-05 Plaintiff alleges Defendants had actual notice of '475 Patent
2026-06-12 Third Amended Complaint filed

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

U.S. Patent No. 9,055,868 - System and Method for Voice Control of Medical Devices

The Invention Explained

  • Problem Addressed: The complaint alleges the invention provides improvements over prior art optical diagnostic systems that lacked flexibility and convenience in operation and control, as well as enhanced data processing and storage capabilities Compl. ¶74
  • The Patented Solution: The invention is a system for non-invasive optical measurement and processing of physiological data Compl. ¶76 It combines an optical measurement device with a wirelessly connected remote control system that accepts voice and manual inputs, and a host system for receiving, storing, and processing the data (Compl. ¶74, citing '868 Patent, 1:39-63). This host system can then communicate the user's status to other remote display devices (Compl. ¶74, citing '868 Patent, 1:63-2:33).
  • Technical Importance: The technology aimed to integrate non-invasive optical sensing with remote control and data management, providing greater operational flexibility for users and enhanced data processing capabilities at different locations Compl. ¶74

Key Claims at a Glance

  • The complaint asserts at least independent claim 7 and dependent claim 9 Compl. ¶177
  • The asserted claims, as summarized in the complaint, comprise a physical system with the following essential components Compl. ¶75:
    • A light source with semiconductor diodes for generating an input light beam.
    • A lens system to direct the light onto a user's body part containing blood.
    • A software application associated with a control system for generating physiological data.
    • The control system itself, featuring touch-screen, voice, and manual inputs, along with circuitry for obtaining position information and a wireless transceiver.
    • A host with a digital file, control logic to process wireless data and generate a user status, and an output for communicating that status to remote display devices.

U.S. Patent No. 9,651,533 - Short-Wave Infrared Super-Continuum Lasers for Detecting Counterfeit or Illicit Drugs and Pharmaceutical Process Control

The Invention Explained

  • Problem Addressed: The patent addresses the "unmet need for non-invasive physiological measurement techniques such as glucose monitoring" and the failure of conventional non-invasive systems to provide "adequate sensitivity, selectivity, and repeatability" (Compl. ¶84, citing '533 Patent, 3:47-63).
  • The Patented Solution: The patent discloses using "brighter light sources" with near-infrared wavelengths to increase the signal from blood constituents, thereby improving the signal-to-noise ratio (Compl. ¶84, citing '533 Patent, 5:35-47). The system includes a wearable measurement device, a personal device (e.g., a smartphone) to receive and process data, and a remote device (e.g., a cloud platform) for storage and further transmission (Compl. ¶¶85-86, Compl. ¶citing '533 Patent, Compl. ¶¶5:54-6:3; '533 Patent, Compl. ¶¶26:27-56). The system also uses techniques like spectral fingerprinting to identify different blood constituents (Compl. ¶84, citing '533 Patent, 4:18-28).
  • Technical Importance: The invention claims to provide more "accurate and reliable non-invasive measurements of physiological parameters" by using signal processing and brighter light sources to achieve a greater signal-to-noise ratio than the prior art Compl. ¶87

Key Claims at a Glance

  • The complaint asserts at least independent claims 11 and 12 Compl. ¶197
  • The asserted claims, as summarized in the complaint, comprise a physical system with the following components Compl. ¶86:
    • A light source with light emitting diodes generating an optical beam in the 700-2500 nanometer wavelength range.
    • A plurality of lenses to deliver an analysis beam to a sample.
    • A receiver to process the reflected beam and generate an output signal.
    • A personal device to receive, process, store, and display the signal.
    • A remote device to receive a wirelessly transmitted status and process it.

U.S. Patent No. 10,517,484 - Semiconductor Diodes-Based Physiological Measurement Device with Improved Signal-to-Noise Ratio

  • Technology Synopsis: The patent addresses the need for non-invasive measurement of bodily functions with sufficient sensitivity and repeatability (Compl. ¶96, citing '484 Patent, 2:57-3:15). It proposes to solve this by synchronizing a detection system to a light source, modulating the light source on and off, and comparing signals to account for ambient light, thereby increasing the signal-to-noise ratio Compl. ¶¶96-97 The system also discloses pattern matching and wireless communication of data to handheld devices and the cloud Compl. ¶98
  • Asserted Claims: Claims 3, 8, 9, and 10 Compl. ¶238
  • Accused Features: The complaint alleges infringement by Defendants' integrated systems, comprising wearable devices, smartphones/tablets, and cloud platforms Compl. ¶99 Compl. ¶238

U.S. Patent No. 10,874,304 - Semiconductor Source Based Near Infrared Measurement Device with Improved Signal-to-Noise Ratio

  • Technology Synopsis: As a continuation related to the '484 Patent, this patent expands on solutions for non-invasive physiological parameter measurement Compl. ¶109 The technology involves a system with a light source, a receiver to capture reflected light from tissue, and a smartphone/cloud platform for data processing Compl. ¶110 It further claims to increase the signal-to-noise ratio by modulating the light source or differencing signals generated when the source is on versus off Compl. ¶111
  • Asserted Claims: Claims 1, 2, 11, 14, 19, and 20 Compl. ¶269
  • Accused Features: The complaint alleges infringement by Defendants' wearable devices and associated systems that incorporate a light source, receiver, smartphone, and cloud computing platform Compl. ¶110 Compl. ¶269

U.S. Patent No. 11,160,455 - Multi-Wavelength Wearable Device for Non-Invasive Blood Measurements in Tissue

  • Technology Synopsis: Also related to the '484 Patent family, this patent discloses solutions for non-invasive physiological measurements Compl. ¶120 The system comprises a light source, lenses, a detection system with spaced detectors, and a smartphone/tablet for processing the signal Compl. ¶121 Signal-to-noise ratio is allegedly improved by increasing light intensity or comparing on/off signals from the semiconductor sources Compl. ¶122
  • Asserted Claims: Claims 1, 2, 3, and 8 Compl. ¶314
  • Accused Features: The complaint alleges infringement by Defendants' systems that include a light source, detection system, and a smartphone/tablet for processing physiological data Compl. ¶121 Compl. ¶314

U.S. Patent No. 12,193,790 - Wearable Devices Comprising Semiconductor Diode Light Sources With Improved Signal-to-Noise Ratio

  • Technology Synopsis: Related to the '484 and '455 Patents, this patent discloses an optical system with a wearable device for a user's wrist Compl. ¶¶131-132 The system uses a semiconductor diode light source, lenses, and spaced detectors to measure physiological parameters from light reflected off the skin Compl. ¶132 It claims to improve signal-to-noise ratio by increasing light intensity and comparing signals from when the light source is on versus off Compl. ¶133
  • Asserted Claims: Claim 7 Compl. ¶345
  • Accused Features: The complaint alleges infringement by Defendants' wrist-worn smartwatches and associated optical systems Compl. ¶132 Compl. ¶345

U.S. Patent No. 12,268,475 - Wearable Device for Differential Measurement on Pulse Rate and Blood Flow

  • Technology Synopsis: Related to the '790, '455, '484, and '533 Patents, this patent is directed to a wearable apparatus with a light source (LEDs), lenses, optical detectors, and a processor Compl. ¶¶142-143 The system alleges improvement to the signal-to-noise ratio by comparing signals when the semiconductor sources are on versus off, synchronizing the detection system, and modulating the light source Compl. ¶144
  • Asserted Claims: Claims 1, 5-8, and 11-13 Compl. ¶376
  • Accused Features: The complaint alleges infringement by Defendants' wearable devices (smartwatches and rings) that incorporate the claimed physical components and signal processing capabilities Compl. ¶143 Compl. ¶376

III. The Accused Instrumentality

Product Identification

The accused instrumentalities are wearable devices and their associated ecosystems sold by the Defendants. These include, among others, the Samsung Galaxy Watch series and Galaxy Ring (Compl. ¶¶163, 166); the OnePlus Watch series (Compl. ¶167); the Fossil Gen 1 through Gen 6 series smartwatches (Compl. ¶170); and the Õura Gen 1 through Gen 4 series smart rings (Compl. ¶173). The accused systems also include the Defendants' respective smartphones, tablets, software applications (e.g., Samsung Health App, OHealth app, Fossil Smartwatches App, Õura app), and cloud computing platforms (e.g., Samsung Cloud, OnePlus Cloud, Õura Cloud) (Compl. ¶164; Compl. ¶165; Compl. ¶166; Compl. ¶167; Compl. ¶168; Compl. ¶169; Compl. ¶170; Compl. ¶171; Compl. ¶172; Compl. ¶173; Compl. ¶174; Compl. ¶175).

Functionality and Market Context

The complaint alleges that when a user wears one of the accused smartwatches or smart rings, the device measures physiological parameters like heartbeat and blood oxygen level using hardware components such as optical sensors (e.g., Samsung's "BioActive sensor") (Compl. ¶163, Compl. ¶165, Compl. ¶167, Compl. ¶170, Compl. ¶173, Compl. ¶175). The devices are configured to transfer this information to a compatible mobile application running on a smartphone or tablet (Compl. ¶165, Compl. ¶169, Compl. ¶172, Compl. ¶175). This information can then be transferred to a cloud computing platform for storage, processing, and display (Compl. ¶165, Compl. ¶169, Compl. ¶175). The complaint alleges Defendants actively market and support these products as integrated systems for measuring and monitoring physiological parameters (Compl. ¶¶163, 167, 170, 173).

IV. Analysis of Infringement Allegations

The complaint does not contain claim chart exhibits, instead referring to them as separate docket entries that were not provided for this analysis. Therefore, a prose summary of the infringement allegations is provided in lieu of a table.

U.S. Patent No. 9,055,868 Infringement Allegations

Plaintiff alleges that the Defendants' accused systems directly infringe at least claims 7 and 9 of the '868 Patent Compl. ¶177 The infringement theory posits that the combination of a Defendant's smartwatch/ring, a smartphone/tablet with a health application, and a cloud-based server constitutes an "integrated diagnostic system" that embodies the claimed invention Compl. ¶177 The complaint alleges that these systems possess all the claimed physical components, including an optical measurement device, a wirelessly connected control system (the smartphone/tablet) with various input methods (touch, voice), and a host (the cloud) for processing and storing data Compl. ¶177
No probative visual evidence provided in complaint.

U.S. Patent No. 9,651,533 Infringement Allegations

Plaintiff alleges that Defendants' systems directly infringe at least claims 11 and 12 of the '533 Patent Compl. ¶197 The infringement theory centers on the assertion that the accused "measurement systems," comprising a smartwatch or ring, a smartphone/tablet, and a cloud server, embody the claimed inventions Compl. ¶197 The complaint alleges these systems contain the claimed components, such as a light source with near-infrared wavelengths, lenses, a receiver, a personal device for processing, and a remote device for storage and further processing, which collectively operate to perform non-invasive physiological measurements Compl. ¶86 Compl. ¶197
No probative visual evidence provided in complaint.

  • Identified Points of Contention:
    • Scope Questions: A primary question for the court may be whether the accused consumer-grade smartwatches and smart rings, which are marketed for general wellness, qualify as "medical devices" or "optical diagnostic systems" as those terms are used in the '868 patent Compl. ¶68 Compl. ¶74 A related question is whether the term "super-continuum lasers" from the title of the '533 patent limits the scope of claims that recite "light emitting diodes," and whether the accused products' LED-based sensors fall within the patent's intended scope (Compl. ¶78, Compl. ¶86).
    • Technical Questions: A key technical question will be whether the accused products' optical sensors and processing methods perform the specific signal-to-noise enhancement techniques recited across several patents, such as increasing light intensity from a baseline, increasing pulse rates, and comparing signals when the light source is on versus off to compensate for ambient light Compl. ¶87 Compl. ¶100 Compl. ¶111 Compl. ¶122 Compl. ¶133 Compl. ¶144 The evidence will need to show that the accused systems' general-purpose sensors perform these specific, claimed functions.

V. Key Claim Terms for Construction

  • For U.S. Patent No. 9,055,868:

    • The Term: "medical device"
    • Context and Importance: The construction of this term is critical because the accused products are mass-market consumer electronics, not traditional, regulated medical hardware. Practitioners may focus on this term because Defendants will likely argue their general-purpose smartwatches are not "medical devices" and therefore fall outside the patent's scope.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The complaint's description of the invention as providing for "non-invasive optical measurement of physiological parameters" could support a functional definition that encompasses consumer wellness devices Compl. ¶76
      • Evidence for a Narrower Interpretation: The patent's title, System and Method for Voice Control of Medical Devices, could suggest a narrower scope limited to devices used in a clinical or diagnostic context, rather than for general consumer wellness Compl. ¶68 The complaint also states the inventor's technology was for "healthcare and medicine applications" Compl. ¶63

  • For U.S. Patent No. 9,651,533:

    • The Term: "light source comprising light emitting diodes"
    • Context and Importance: The patent is titled Short-Wave Infrared Super-Continuum Lasers..., creating a potential tension with the asserted claims that recite "light emitting diodes." Practitioners may focus on this term because the infringement analysis will turn on whether the accused products' conventional LEDs are covered by claims in a patent seemingly directed to a more complex and specific "super-continuum laser" technology.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The complaint's summary of the asserted claims explicitly recites "light source comprising light emitting diodes," which on its face appears broader than the technology in the patent's title Compl. ¶86
      • Evidence for a Narrower Interpretation: The patent's background describes a need for "brighter light sources" to increase signal levels, and the specification allegedly discloses using "near-infrared wavelengths" Compl. ¶84 This context may be used to argue that the claimed "light emitting diodes" must possess the specific high-brightness and wavelength characteristics of the advanced sources taught in the specification, not just any generic LED.

VI. Other Allegations

  • Indirect Infringement: The complaint makes detailed allegations of induced and contributory infringement against all Defendants for all asserted patents. For inducement, Plaintiff alleges Defendants actively encourage infringement by providing instructions, marketing materials, software applications, and technical support that direct end-users to combine the wearable devices with smartphones and cloud platforms to form the complete infringing systems (Compl. ¶¶179-182; ¶199-202). For contributory infringement, Plaintiff alleges the provided components are especially made or adapted for use in an infringing manner and are not staple articles of commerce suitable for substantial non-infringing use (Compl. ¶¶184, 204).
  • Willful Infringement: Willfulness allegations are based on both pre-suit and post-suit knowledge. The complaint alleges specific pre-suit notice to Samsung through a series of meetings and presentations from 2017 to 2023 where the patents and technology were discussed (Compl. ¶¶148-160). It alleges pre-suit notice to Õura based on Õura's own patenting activities that cited the asserted patents (Compl. ¶161). For all defendants, it alleges notice at least from the service of the original and amended complaints, followed by continued infringing conduct (Compl. ¶147, Compl. ¶183, Compl. ¶203).

VII. Analyst's Conclusion: Key Questions for the Case

  • A core issue will be one of definitional scope: can terms like "medical device" and "diagnostic system," rooted in a clinical context, be construed to cover mass-market consumer electronics like smartwatches and smart rings intended for general wellness monitoring?
  • A key evidentiary question will be one of technical operation: does the evidence show that the optical sensors and software in the accused consumer wearables perform the specific, multi-step signal processing methods recited in the patents for improving signal-to-noise ratio, or is there a fundamental mismatch between the claimed techniques and the products' actual functionality?
  • A central legal and factual question will be one of system-level infringement: can the Plaintiff prove that the combination of a wearable device, a smartphone application, and a cloud service-often provided by different entities and used variably by consumers-constitutes a single, complete "system" or "apparatus" that meets all limitations of an asserted system claim?
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