DCT

1:18-cv-00691

Masimo Corp v. True Wearables Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 8:18-cv-02001, C.D. Cal., 06/17/2019
  • Venue Allegations: Venue is alleged as proper in the Central District of California because Defendant Lamego resides in the district and Defendant True Wearables has a regular and established place of business in the district.
  • Core Dispute: Plaintiffs allege that Defendants’ Oxxiom pulse oximeter infringes six patents related to pulse oximetry technology, including methods for improving signal processing accuracy and features of sensor design.
  • Technical Context: Pulse oximetry is a non-invasive method for monitoring a person's arterial oxygen saturation (SpO2), a critical physiological parameter in both clinical and consumer health settings.
  • Key Procedural History: The complaint alleges that Defendant Marcelo Lamego is a former high-level engineer and Chief Technical Officer for Plaintiffs, where he was allegedly exposed to the confidential information and patented technology now asserted against him and his new company, True Wearables. These allegations of prior knowledge form the basis for Plaintiffs' claims of willful infringement.

Case Timeline

Date Event
1999-08-26 Priority Date for ’966 Patent
2001-07-02 Priority Date for ’866 Patent
2006-10-12 Priority Date for ’564 and ’847 Patents
2007-03-06 ’966 Patent Issued
2007-11-13 ’866 Patent Issued
2009-07-29 Priority Date for ’271 and ’848 Patents
2014-11-11 ’271 Patent Issued
2015-03-17 ’564 Patent Issued
2019-02-05 ’847 Patent Issued
2019-02-05 ’848 Patent Issued
2019-06-17 Complaint Filing Date

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

U.S. Patent No. 8,983,564 - "Perfusion Index Smoother"

  • Issued: March 17, 2015

The Invention Explained

  • Problem Addressed: The patent describes that in pulse oximetry, motion-induced noise and signal distortion can cause the calculated perfusion index (PI)—a measure of blood flow—to be erroneously high, which may incorrectly suggest to a caregiver that a patient has better perfusion than is actually the case (’564 Patent, col. 3:5-14).
  • The Patented Solution: The invention claims to solve this problem by providing a "smoother" that processes physiological data. This system can use a baseline PI value established during periods of good signal quality to correct for noisy measurements, or it can calculate PI using multiple different techniques and then select or determine a final value, for example, by choosing the lowest calculated value, which tends to be more accurate when noise is present (’564 Patent, col. 3:15-24; col. 4:8-14). Figure 7 of the patent depicts a system using multiple PI calculators to feed a PI selector that determines the final output (’564 Patent, Fig. 7).
  • Technical Importance: This technology aims to provide more reliable and accurate perfusion index measurements, which can be a critical diagnostic tool for predicting illness severity, particularly in neonatal patients (’564 Patent, col. 2:18-27).

Key Claims at a Glance

  • The complaint asserts infringement of at least Claims 1-3 of the ’564 patent (Compl. ¶119). Independent Claim 1 includes the following essential elements:
    • A method of determining an indication of perfusion index in a patient monitor
    • receiving pleth data
    • calculating at least two indications of perfusion index using at least two different calculation techniques
    • determining a final indication of perfusion index based on the at least two indications of perfusion index

U.S. Patent No. 8,886,271 - "Non-Invasive Physiological Sensor Cover"

  • Issued: November 11, 2014

The Invention Explained

  • Problem Addressed: The patent's background section notes that physiological sensors, like pulse oximeters, are often left attached to monitors in clinical settings even when not actively in use on a patient. This can lead to the sensor detecting ambient light and generating false readings or nuisance alarms, which can be distracting to medical personnel (’271 Patent, col. 1:20-31).
  • The Patented Solution: The invention is a sensor cover that is at least partially opaque and is configured to be adhered to the sensor. The cover blocks the sensor's detector from receiving light when the sensor is not in use, thereby preventing false readings. The cover also includes a "protruding portion" designed to make it easy for a user to remove it before applying the sensor to a patient (’271 Patent, Abstract; col. 2:34-40).
  • Technical Importance: The claimed sensor cover improves the utility of sensors in clinical environments by reducing false alarms and can also help prevent contamination or damage to the sensor components before use (’271 Patent, col. 2:32-46).

Key Claims at a Glance

  • The complaint asserts infringement of at least Claims 1-2, 6-11, and 15-18, with a specific example citing Claim 10 (Compl. ¶¶133, 135). Independent Claim 1 includes the following essential elements:
    • A sensor covering system comprising a pulse oximeter sensor and a sensor cover
    • The sensor cover is configured to be adhered to the pulse oximeter sensor and removed before use
    • The sensor cover is at least partially opaque
    • At least a portion of the sensor cover protrudes from the pulse oximeter sensor to facilitate removal
    • When adhered, the sensor cover covers at least one sensing component and blocks at least a portion of light from being received by the detector

Multi-Patent Capsules

  • U.S. Patent No. 7,295,866 - "Low Power Pulse Oximeter"

    • Issued: November 13, 2007.
    • Technology Synopsis: The patent addresses the need for reduced power consumption in portable, battery-operated pulse oximeters. The described solution involves adaptively sampling the physiological signal, such as by varying the duty cycle of the drive current to the sensor's light emitters, in order to lower power usage during stable conditions while maintaining performance during critical events like oxygen desaturations (’866 Patent, Abstract).
    • Asserted Claims: Claims 10-12 are asserted, with Claim 10 being independent (Compl. ¶144).
    • Accused Features: The complaint alleges that the Oxxiom device's controller (Nordic nRF51422) configures its emitter driver (Texas Instruments AFE4403) to switch between different duty cycles, thereby varying power consumption (Compl. ¶¶146-147).

  • U.S. Patent No. 7,186,966 - "Amount of Use Tracking Device and Method for Medical Product"

    • Issued: March 6, 2007.
    • Technology Synopsis: The patent addresses the need for timely replacement of medical sensors that have a limited usable life. The invention is a system that monitors the amount of use for a sensor and activates an indicator (such as a visual alarm or a power-down function) when a predetermined amount of use has been exceeded (’966 Patent, Abstract).
    • Asserted Claims: Claims 1, 4, 15, and 19 are asserted, with Claims 1 and 15 being independent (Compl. ¶157).
    • Accused Features: The complaint alleges the Oxxiom device and its application track the cumulative amount of use and provide an alert, such as a red "X" on the battery icon, when a predetermined time (e.g., twenty-four hours) has expired (Compl. ¶¶159, 161).

  • U.S. Patent No. 10,194,847 - "Perfusion Index Smoother"

    • Issued: February 5, 2019.
    • Technology Synopsis: Related to the ’564 Patent, this invention also concerns methods for improving the accuracy of perfusion index (PI) measurements from a pulse oximeter. It describes processing plethysmograph data to determine amplitude, using signal quality and statistical analysis to determine a final indication of amplitude, and outputting that as the PI (’847 Patent, Abstract).
    • Asserted Claims: Claims 1-4 are asserted, with Claim 1 being independent (Compl. ¶170).
    • Accused Features: The Oxxiom device is accused of determining first and second indications of amplitude from pleth data and using a signal quality indication and statistical analysis to determine a final indication of amplitude, which is output as the perfusion index (Compl. ¶174).

  • U.S. Patent No. 10,194,848 - "Non-Invasive Physiological Sensor Cover"

    • Issued: February 5, 2019.
    • Technology Synopsis: Related to the ’271 Patent, this invention describes a cover for a non-invasive physiological sensor. The cover is designed to block light from reaching the sensor's detector to prevent false readings when the sensor is not in use, and it includes a protruding portion to facilitate its removal before the sensor is applied to a patient (’848 Patent, Abstract).
    • Asserted Claims: All claims (1-29) are asserted, with Claims 1 and 9 being independent (Compl. ¶182).
    • Accused Features: The Oxxiom device is alleged to have a cover portion configured to be adhered to the sensor and a protruding portion ("Tab 2") that facilitates removal of the cover before use (Compl. ¶184).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is the "Oxxiom" pulse oximeter device and its corresponding software application, manufactured and sold by Defendant True Wearables, Inc. (Compl. ¶¶4, 119).

Functionality and Market Context

  • The Oxxiom is a wireless, disposable pulse oximeter that receives photoplethysmograph ("pleth") data from an integrated sensor component (identified as an Osram SFH7050) (Compl. ¶122). The device and its application process this data to determine and display a user's blood oxygen saturation (SpO2), pulse rate (PR), and perfusion index (PI) (Compl. ¶121). The complaint includes a screenshot from the True Wearables website showing the Oxxiom application's user interface displaying these physiological parameters (Compl. ¶121). The device is alleged to contain a controller (Nordic Semiconductor nRF51422) and an emitter driver (Texas Instruments AFE4403) that enable it to vary its power consumption (Compl. ¶¶146–147). It also includes a removable cover with a tab to protect the sensor before use and a software function to track its usage duration (Compl. ¶¶135, 161).
  • The complaint alleges that the Oxxiom device is intended to compete directly with Plaintiffs' own pulse oximetry products (Compl. ¶4).

IV. Analysis of Infringement Allegations

U.S. Patent No. 8,983,564 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of determining an indication of perfusion index...comprising receiving pleth data The Oxxiom device receives plethysmograph ("pleth") data based on a signal from a detector within the device. ¶122 col. 1:41-43
calculating at least two indications of perfusion index using at least two different calculation techniques On information and belief, when the Oxxiom device is tapped or rubbed, its perfusion index readings demonstrate the use of at least two different PI calculation techniques. ¶123 col. 4:8-14
determining a final indication of perfusion index based on the at least two indications... The Oxxiom application displays a "resulting indication of perfusion index" and allegedly chooses a calculation technique that results in a lower PI value. ¶¶123-124 col. 4:10-12
  • Identified Points of Contention:
    • Technical Questions: A primary question may be evidentiary. The complaint alleges "upon information and belief" that the device uses two different calculation techniques, based on observing its readings when "tapped or rubbed" (Compl. ¶123). Discovery will need to establish whether the device's software architecture actually contains two or more distinct PI calculation algorithms, or if the observed behavior is merely the output of a single algorithm reacting to motion artifact.

U.S. Patent No. 8,886,271 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A sensor covering system, the sensor covering system comprising: a pulse oximeter sensor...and a sensor cover... The Oxxiom device is a pulse oximeter that includes a sensor and a cover. The complaint provides an instructional diagram from the True Wearables website showing the sensor and its cover components (Compl. p. 34). ¶¶133, 135 col. 1:21-27
the sensor cover is configured to be adhered to the pulse oximeter sensor and removed before use The instructions for the Oxxiom device show a cover portion with a "Pull tab 2" that is removed to prepare the sensor for placement. ¶135 col. 4:10-14
the sensor cover is at least partially opaque The complaint alleges the Oxxiom device includes an "opaque portion attachable to the sensor." ¶135 col. 4:1-2
at least a portion of the sensor cover protrudes from the pulse oximeter sensor to facilitate removal of the sensor cover The complaint identifies "tab 2" on the Oxxiom device as the protruding portion that facilitates removal. ¶135 col. 2:38-40
  • Identified Points of Contention:
    • Scope Questions: The infringement analysis may raise the question of whether the protective backing on the disposable Oxxiom sensor, which is peeled off and discarded before use, constitutes the "sensor cover" as claimed. While the claim language appears to read on this structure, a dispute could arise over whether the patent contemplates a more distinct or reusable component.

V. Key Claim Terms for Construction

  • The Term: "different calculation techniques" (from Claim 1 of the ’564 Patent)
  • Context and Importance: This term is dispositive for infringement of the ’564 and ’847 patents. The core of the infringement allegation is that the Oxxiom device calculates PI using at least two distinct methods. If the device's response to signal noise is determined to be a function of a single, adaptive algorithm rather than a selection between "different techniques," infringement may not be found.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent specification describes using "multiple PI calculation techniques" generally and depicts a system with multiple "PI Calculator" blocks feeding a "PI Selector" without narrowly defining what constitutes a "different" technique (’564 Patent, Fig. 7; col. 6:64-66). This could support a reading where any two algorithms that are not identical qualify.
    • Evidence for a Narrower Interpretation: The specification provides an example where one technique is a "pulse by pulse determination" and another is based on a "fixed or variable interval of pleth data including more than one pulse" (’564 Patent, col. 7:11-21). A defendant may argue that "different techniques" should be construed to require similarly distinct methodological approaches, not just minor variations in filtering or signal processing parameters.
  • The Term: "sensor cover" (from Claim 1 of the ’271 Patent)
  • Context and Importance: Infringement of the ’271 and ’848 patents depends on whether the peel-off backing on the accused Oxxiom sensor meets the definition of the claimed "sensor cover." Practitioners may focus on this term because the accused feature is a common element of disposable adhesive sensors, and its construction will determine the patent's applicability to a wide range of products.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification describes embodiments where the cover can be "peeled off" and can be made from "plastic film," and the claims require it to be "removed before use" (’271 Patent, col. 4:26; col. 4:40-41; Claim 1). This language may support a broad construction that includes disposable adhesive backings.
    • Evidence for a Narrower Interpretation: The figures consistently depict the "sensor cover" as a distinct element (e.g., item 140 in Fig. 2A) that is attached to, but not necessarily integral with, the sensor's primary adhesive layer. A defendant might argue that the term implies a component separate from the standard protective liner of an adhesive strip.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that True Wearables induces infringement by providing "instructions and teachings" and "manuals" that direct customers and end users to operate the Oxxiom device in an infringing manner (Compl. ¶¶126, 137, 150, 163, 175, 185). The user instructions for removing "Tab 2" are provided as a specific example supporting inducement of the ’271 Patent (Compl. ¶135).
  • Willful Infringement: Willfulness is alleged for all asserted patents. The allegations are based on Defendant Lamego's prior role as a high-level executive and Chief Technical Officer at Plaintiffs, where he allegedly had direct knowledge of Plaintiffs' patent portfolio and IP strategy. The complaint specifically alleges that Lamego was employed by Cercacor when the patent applications for the ’564 and ’271 patents were filed and published, giving him pre-suit knowledge of the technology (Compl. ¶¶125, 136, 149, 162).

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

  • A core issue will be one of technical proof: for the signal processing patents (’564, ’847, ’866), what evidence will show that the accused Oxxiom device performs the specific functions claimed, such as using "two different calculation techniques" or varying power consumption via distinct "duty cycles," as opposed to using a single, unified algorithm that adapts to changing signal conditions?
  • A central dispute will be one of intent and prior knowledge: given Defendant Lamego’s extensive history with Plaintiffs, the case will likely focus on whether the accused Oxxiom device was developed with knowledge of and an intent to copy the asserted patents, which will be critical to the question of willful infringement.
  • A key question of claim scope will arise for the sensor cover patents (’271, ’848): can the term "sensor cover," as defined and used in the patents, be construed to read on the disposable adhesive backing of the accused Oxxiom sensor, a common feature in the industry?