DCT

2:18-cv-00134

Omni MedSci Inc v. Apple Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:18-cv-00134, E.D. Tex., 04/06/2018
  • Venue Allegations: Plaintiff alleges venue is proper because Apple maintains two regular and established places of business in the district and sells the accused products at those locations.
  • Core Dispute: Plaintiff alleges that Defendant’s Apple Watch products infringe patents related to using optical sensors, such as near-infrared light-emitting diodes, to non-invasively measure physiological parameters.
  • Technical Context: The technology at issue involves wearable optical sensors for physiological monitoring, a central feature in the commercially significant smartwatch and personal health device market.
  • Key Procedural History: The complaint alleges a history of communications between Plaintiff's principal and Apple personnel between June 2014 and July 2016, during which Plaintiff’s patent-pending technology was discussed and an opportunity to license was allegedly declined. Plaintiff further alleges it explicitly notified Apple of the issued patents in December 2017. These allegations form the basis for the claim of willful infringement.

Case Timeline

Date Event
2012-12-31 Priority Date for all Patents-in-Suit
2014-06-11 Meeting alleged between Dr. Islam and Apple employees
2015-02-05 Meeting alleged between Dr. Islam and approximately ten Apple employees
2016-07-14 Email exchange alleged between Apple employee and Dr. Islam
2016-07-18 Meeting alleged between Dr. Islam and Apple employees
2017-05-16 U.S. Patent No. 9,651,533 Issues
2017-09-12 U.S. Patent No. 9,757,040 Issues
2017-12-21 Plaintiff alleges providing notice of issued patents to Apple
2018-01-09 U.S. Patent No. 9,861,286 Issues
2018-02-06 U.S. Patent No. 9,885,698 Issues
2018-04-06 Complaint Filed

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

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

  • Patent Identification: U.S. Patent No. 9,651,533, “Short-Wave Infrared Super-Continuum Lasers for Detecting Counterfeit or Illicit Drugs and Pharmaceutical Process Control,” Issued May 16, 2017.

The Invention Explained

  • Problem Addressed: The patent's specification describes challenges in non-invasively monitoring blood constituents, such as glucose, noting that weak signals and spectral artifacts from skin and other blood components complicate accurate measurement (’533 Patent, col. 4:1-14).
  • The Patented Solution: The invention describes a measurement system, which can be embodied in a wearable device, that uses a light source with multiple semiconductor light-emitting diodes (LEDs) to generate a near-infrared optical beam. The system is configured to improve the signal-to-noise ratio by increasing the light intensity and pulse rate of the LEDs, allowing for more reliable detection of physiological parameters from light reflected by the user's tissue ('533 Patent, Abstract; Fig. 24).
  • Technical Importance: The described methods aim to enhance the signal quality and accuracy of non-invasive physiological monitoring, a critical factor for the reliability and utility of wearable health-tracking devices (Compl. ¶11).

Key Claims at a Glance

  • The complaint asserts independent claim 5 (Compl. ¶36).
  • Essential elements of Claim 5 include:
    • A measurement system comprising a light source with a plurality of LEDs.
    • The LEDs are configured to generate a near-infrared optical beam (700-2500 nm).
    • The light source is configured to increase the signal-to-noise ratio by increasing light intensity and pulse rate.
    • An apparatus with lenses to deliver the beam to a sample.
    • A receiver, synchronized to the light source, to process the reflected beam and generate a signal.
    • A personal device (e.g., smartphone) to receive, process, and display the signal.
    • The personal device is configured to transmit the processed signal over a wireless link.
    • A remote device (e.g., cloud server) to receive, process, and store data from the wireless link.
  • The complaint reserves the right to assert additional claims, including dependent claims 7-10, 13, 16, and 17 (Compl. ¶36).

U.S. Patent No. 9,757,040 - “Short-Wave Infrared Super-Continuum Lasers for Early Detection of Dental Caries”

  • Patent Identification: U.S. Patent No. 9,757,040, “Short-Wave Infrared Super-Continuum Lasers for Early Detection of Dental Caries,” Issued September 12, 2017.

The Invention Explained

  • Problem Addressed: While the patent title refers to dental caries, the broader technical problem addressed in the asserted claims relates to obtaining accurate physiological measurements using wearable optical sensors in the presence of ambient light and other noise sources (’040 Patent, Background and Summary).
  • The Patented Solution: The invention is a wearable device that improves the signal-to-noise ratio of its optical measurements using two primary techniques. First, it increases the intensity of the light emitted from its LEDs. Second, it employs a specific noise-cancellation method where the receiver captures a signal when the LEDs are off (ambient light) and another when they are on (ambient light + reflected signal), then improves the signal-to-noise ratio by differencing the two signals ('040 Patent, Abstract; col. 4:50-59).
  • Technical Importance: This approach seeks to improve the reliability of wearable sensors by actively canceling ambient light interference, a significant challenge for devices used in varied real-world lighting conditions (Compl. ¶11).

Key Claims at a Glance

  • The complaint asserts independent claim 1 (Compl. ¶49).
  • Essential elements of Claim 1 include:
    • A wearable device for use with a smart phone or tablet, comprising a measurement device with multiple LEDs.
    • The device generates a modulated, near-infrared optical beam (700-2500 nm).
    • Lenses deliver the beam to tissue, and a reflective surface redirects a portion of the light reflected from the tissue.
    • A receiver captures a first signal while LEDs are off and a second signal while at least one LED is on.
    • The device improves the signal-to-noise ratio by differencing the first and second signals.
    • The light source further improves the signal-to-noise ratio by increasing the light intensity of the LEDs.
    • The device generates an output signal representing a non-invasive measurement on blood.
    • The device is configured to communicate with a smart phone or tablet, which can process and transmit the data.
  • The complaint reserves the right to assert additional claims, including dependent claims 2 and 4 (Compl. ¶49).

Multi-Patent Capsule: U.S. Patent No. 9,861,286

  • Patent Identification: U.S. Patent No. 9,861,286, “Short-Wave Infrared Super-Continuum Lasers for Early Detection of Dental Caries,” Issued January 9, 2018.
  • Technology Synopsis: The technology is a wearable device for measuring physiological parameters using near-infrared LEDs. It describes improving signal-to-noise ratio by differencing signals captured when the LEDs are on versus off, and by increasing light intensity. This patent's asserted claims specify that the receiver includes a "plurality of spatially separated detectors" (’286 Patent, Claim 16).
  • Asserted Claims: Independent Claim 16 (Compl. ¶65).
  • Accused Features: The Apple Watch's alleged use of multiple, spatially separated photodiode sensors to measure heart rate (Compl. ¶77).

Multi-Patent Capsule: U.S. Patent No. 9,885,698

  • Patent Identification: U.S. Patent No. 9,885,698, “Short-Wave Infrared Super-Continuum Lasers for Detecting Counterfeit or Illicit Drugs and Pharmaceutical Process Control,” Issued February 6, 2018.
  • Technology Synopsis: The technology is a wearable device for measuring physiological parameters using modulated near-infrared LEDs. A key aspect of the asserted claim is the use of a "lock-in technique" where the receiver is configured to detect the specific modulation frequency of the LEDs to enhance signal detection (’698 Patent, Claim 1).
  • Asserted Claims: Independent Claim 1 (Compl. ¶81).
  • Accused Features: The Apple Watch's alleged modulation of its LEDs at a frequency of hundreds of times per second and its receiver's alleged use of a lock-in technique to detect that frequency (Compl. ¶93).

III. The Accused Instrumentality

Product Identification

  • The accused products are Apple's "Apple Watch" line, including "Series 1," "Series 2," "Series 3 GPS," and "Series 3 GPS + Cellular" models (collectively, "Watches") (Compl. ¶20).

Functionality and Market Context

  • The complaint alleges that the Watches are wearable devices that perform non-invasive heart rate measurement using semiconductor LEDs that emit light in the near-infrared spectrum (Compl. ¶¶21-23). The complaint includes a visual of the underside of an Apple Watch showing the arrangement of its optical components (Compl. p. 7). This image depicts the LEDs and photodiode sensors used for heart rate sensing.
  • The accused functionality includes modulating the light emitted from the LEDs, increasing the intensity and pulse rate of the LEDs to improve signal quality, and employing a lock-in technique to detect the modulation frequency (Compl. ¶¶24-27).
  • The Watches are alleged to contain lenses to direct light to the user's skin and detectors to receive the reflected light, which is processed by analog-to-digital converters (Compl. ¶¶28-30).
  • The complaint further alleges the Watches are capable of improving the signal-to-noise ratio by capturing and differencing light signals when the LEDs are on versus off (Compl. ¶32). The Watches communicate wirelessly with other Apple devices, such as an iPhone, for processing, display, and transmission of the physiological data to remote services like iCloud (Compl. ¶¶33, 44-46).

IV. Analysis of Infringement Allegations

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

Claim Element (from Independent Claim 5) Alleged Infringing Functionality Complaint Citation Patent Citation
A measurement system comprising: a light source comprising a plurality of semiconductor sources that are light emitting diodes. The Apple Watch uses multiple LEDs that are semiconductor light sources to measure heart rate. ¶38 col. 4:51-53
...the light emitting diodes configured to generate an output optical beam with...a near-infrared wavelength between 700 nanometers and 2500 nanometers. The Apple Watch's LEDs are infrared and emit wavelengths within the claimed near-infrared range. ¶39 col. 4:53-56
...the light source configured to increase signal-to-noise ratio by increasing a light intensity...and by increasing a pulse rate... The Apple Watch's heart rate sensor allegedly compensates for low signal levels by increasing LED brightness and increasing the sampling rate. ¶40 col. 4:56-59
...an apparatus comprising a plurality of lenses configured to receive a portion of the output optical beam and to deliver an analysis output beam to a sample. The Apple Watch includes a plurality of lenses on its underside, shown in a complaint visual, to deliver the light beam to the user's skin. ¶41 col. 4:59-62
...a receiver configured to receive and process at least a portion of the analysis output beam reflected...from the sample and to generate an output signal. The Apple Watch includes photodiode sensors that receive the light reflected from the skin and generate an output signal containing heart rate information. ¶42 col. 4:63-66
...wherein the receiver is configured to be synchronized to the light source. The receiver in the Apple Watch is alleged to be synchronizable with the watch's LEDs. ¶43 col. 5:19-21
...a personal device comprising a wireless receiver, a wireless transmitter, a display...configured to receive and process...store and display the processed output signal. An Apple iPhone acts as the personal device, which wirelessly receives, processes, stores, and displays heart rate data from the Apple Watch. ¶44 col. 4:66-5:5
...wherein at least a portion of the processed output signal is configured to be transmitted over a wireless transmission link. The personal device (iPhone) transmits the heart rate data over a wireless link to Apple's iCloud service. ¶45 col. 5:5-7
...a remote device configured to receive...an output status...to process the received output status to generate processed data and to store the processed data. Apple's iCloud service acts as the remote device that receives, processes, and stores the heart rate data transmitted from the iPhone. ¶46 col. 5:8-12
  • Identified Points of Contention:
    • Scope Questions: Claim 5 recites a three-part "measurement system" comprising the light source/receiver apparatus (the Watch), a "personal device" (the iPhone), and a "remote device" (iCloud). The analysis may raise the question of whether Apple directly infringes by making or selling this entire system, as the end-user typically provides the personal device and subscribes to the remote service separately.
    • Technical Questions: The complaint alleges that increasing the "sampling rate" meets the claim limitation of "increasing a pulse rate." The infringement analysis may focus on whether these terms describe technically equivalent functions in the context of the patent.

U.S. Patent No. 9,757,040 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A wearable device...comprising: a measurement device including a light source comprising a plurality of light emitting diodes...for measuring one or more physiological parameters. The Apple Watch is a wearable device that uses multiple LEDs to measure physiological parameters, namely heart rate. ¶51 col. 4:40-42
...the measurement device configured to generate, by modulating at least one of the LEDs...an input optical beam...[with a] near-infrared wavelength between 700 nanometers and 2500 nanometers. The Apple Watch modulates its infrared LEDs by fluctuating their brightness to generate an optical beam in the claimed wavelength range. ¶¶52-53 col. 4:42-45
...one or more lenses configured to...deliver a portion of the input optical beam to tissue. The Apple Watch includes lenses to deliver the optical beam to the user's skin, which constitutes tissue. ¶54 col. 4:42-43
...the measurement device further comprising a reflective surface configured to receive and redirect at least a portion of light reflected from the tissue. The Apple Watch allegedly includes mirrors around its LEDs and sensors to receive and redirect light reflected from the skin. ¶56 col. 4:43-45
...a receiver configured to: capture light while the LEDs are off and convert the captured light into a first signal and capture light while at least one of the LEDs is on and convert...into a second signal... The complaint alleges on information and belief that the Apple Watch's sensors capture light when LEDs are off (first signal) and on (second signal). ¶57 col. 4:53-57
...the measurement device configured to improve a signal-to-noise ratio...by differencing the first signal and the second signal. The complaint alleges on information and belief that the Apple Watch improves signal-to-noise ratio by differencing the "first" and "second" signals. ¶58 col. 4:57-59
...the light source configured to further improve the signal-to-noise ratio...by increasing the light intensity...from at least one of the LEDs. The Apple Watch improves the signal-to-noise ratio by increasing the brightness of its LEDs. ¶59 col. 4:45-46
...the smart phone or tablet comprising a wireless receiver, a wireless transmitter, a display...configured to receive and to process...store and display the processed output signal... An iPhone or iPad serves as the smart phone/tablet, which has the recited components and wirelessly communicates with the Watch to receive, process, and display data. ¶62 col. 4:51-53
  • Identified Points of Contention:
    • Scope Questions: The claim requires a "reflective surface." The infringement analysis may question whether the structures alleged to be "mirrors" in the Apple Watch (Compl. ¶56) meet the structural and functional requirements of this term as used in the patent.
    • Technical Questions: The allegations that the Watch performs a specific two-step signal capture (LEDs on/off) and differencing process are made "on information and belief" (Compl. ¶¶57-58). A key evidentiary question will be whether discovery confirms that the accused product operates in this specific manner to cancel ambient noise.

V. Key Claim Terms for Construction

  • Term: "measurement system" ('533 Patent, Claim 5)

    • Context and Importance: This term is critical because Claim 5 recites a multi-component system comprising the wearable device, a separate "personal device," and a "remote device." Direct infringement requires that a single party makes, uses, sells, or offers to sell the entire claimed system. Practitioners may focus on this term because Apple sells the Watch, but the user typically owns the "personal device" (iPhone) and utilizes the "remote device" (iCloud) as a service, raising questions about whether any single entity directly infringes the complete combination.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The patent specification consistently describes the components as an integrated system designed to work together. Figure 24 explicitly illustrates the wearable device (2401), the personal device (2405), and the cloud/remote device (2407) communicating and functioning as a single unit, which may support an argument that the components are inseparable parts of one offering ('533 Patent, Fig. 24; col. 5:29-33).
      • Evidence for a Narrower Interpretation: The claim language distinctly enumerates three separate components: the light source and receiver apparatus, the personal device, and the remote device ('533 Patent, col. 5:1-12). This explicit separation may support an argument that the claim requires three physically distinct but co-acting parts, and that direct infringement is only possible if one party controls or supplies all three.

  • Term: "receiver configured to: capture light while the LEDs are off and convert...into a first signal and capture light while at least one of the LEDs is on and convert...into a second signal" ('040 Patent, Claim 1)

    • Context and Importance: This functional language defines a specific method for ambient light cancellation that is central to the novelty of the claim. Infringement hinges on whether the Apple Watch performs this exact two-step sequence of capturing and converting distinct signals. Practitioners may focus on this term because the allegation is made "on information and belief," indicating that the precise internal workings of the accused device are not publicly known and will be a subject of discovery.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The patent's abstract and specification describe this process as a means to "increase a signal-to-noise ratio" ('040 Patent, Abstract). This stated purpose could support an interpretation where any mechanism that separately measures ambient and combined light for subsequent differencing would meet the limitation, regardless of the precise implementation.
      • Evidence for a Narrower Interpretation: The claim language recites a specific sequence: "capture...and convert...into a first signal" followed by "capture...and convert...into a second signal," which are then differenced ('040 Patent, col. 4:53-59). This may support a narrower construction requiring the creation of two discrete, digitized signals before any differencing occurs, as opposed to a continuous analog subtraction or another noise-cancellation method.

VI. Other Allegations

  • Willful Infringement: The complaint includes a count for willful infringement, alleging that Apple had pre-suit knowledge of the patents or was willfully blind to its infringement (Compl. ¶¶94-96). The basis for this allegation is a series of communications and meetings between Plaintiff's principal and Apple personnel from 2014 to 2016, where Plaintiff's technology was allegedly discussed (Compl. ¶¶13-17, 95). The claim is further based on an alleged email communication from December 21, 2017, in which Plaintiff purportedly identified the issued patents-in-suit to Apple personnel (Compl. ¶¶18, 95).

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

  • A central issue will be one of system liability: can Plaintiff prove that Apple's sale of the Apple Watch, which functions in concert with user-owned iPhones and Apple-provided iCloud services, constitutes direct infringement of system claims requiring all three components, or does this arrangement preclude a finding of direct infringement by a single party?
  • A key evidentiary question will be one of functional operation: does discovery reveal that the Apple Watch's heart rate sensor performs the specific technical operations recited in the claims, such as the two-step signal capture and differencing for noise cancellation, or does it employ a functionally different, non-infringing method to achieve a similar result?
  • The viability of the willfulness claim will depend on the specificity of pre-suit notice: did the alleged 2014-2016 discussions and the December 2017 email provide Apple with knowledge of the patented technology with sufficient clarity to support a finding that its alleged infringement was knowing or willfully blind?