DCT

8:18-cv-02001

Masimo Corp v. True Wearables Inc

Log In

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 to be 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 within the district.
  • Core Dispute: Plaintiffs allege that Defendants’ Oxxiom pulse oximeter infringes six patents related to physiological monitoring, and further allege that Defendant Lamego, a former executive of Plaintiffs, misappropriated trade secrets and breached contractual and fiduciary duties to develop the accused products.
  • Technical Context: The technology relates to noninvasive physiological monitoring, specifically pulse oximetry, which measures parameters such as blood oxygen saturation and perfusion index for use in medical and consumer health applications.
  • Key Procedural History: The complaint does not reference prior litigation or administrative patent challenges; however, it extensively details the employment history of Defendant Lamego at Masimo and Cercacor, alleging he was given access to Plaintiffs' confidential information and trade secrets, which forms the basis for the allegations of willful infringement and trade secret misappropriation.

Case Timeline

Date Event
1999-08-26 Priority Date for U.S. Patent No. 7,186,966
2000-06-26 Defendant Lamego signs first employment agreement with Masimo
2001-07-02 Priority Date for U.S. Patent No. 7,295,866
2003-01-28 Defendant Lamego signs second employment agreement with Masimo
2005-01-31 Defendant Lamego signs third employment agreement with Masimo
2006-10-12 Priority Date for U.S. Patent Nos. 8,983,564 and 10,194,847
2007-03-06 U.S. Patent No. 7,186,966 Issues
2007-11-13 U.S. Patent No. 7,295,866 Issues
2009-05-19 Defendant Lamego signs employment agreement with Cercacor
2009-07-29 Priority Date for U.S. Patent Nos. 8,886,271 and 10,194,848
2012-09-26 Patent application leading to '564 Patent filed
2013-06-17 Patent application leading to '271 Patent filed
2014-01-01 Defendant Lamego resigns from Cercacor (approx. date)
2014-11-11 U.S. Patent No. 8,886,271 Issues
2015-03-17 U.S. Patent No. 8,983,564 Issues
2018-04-26 Patent application filed by Defendant Lamego published
2019-02-05 U.S. Patent No. 10,194,847 Issues
2019-02-05 U.S. Patent No. 10,194,848 Issues
2019-06-17 Complaint Filed

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

U.S. Patent No. 8,983,564: "Perfusion Index Smoother" (Issued Mar. 17, 2015)

The Invention Explained

  • Problem Addressed: The patent describes that physiological measurements like Perfusion Index (PI) can be corrupted by motion-induced noise, which often causes the measured PI value to be erroneously high (U.S. Patent No. 8983564, col. 3:5-14). This could mislead a caregiver into believing a patient's blood perfusion is better than it actually is, potentially masking a serious medical issue (Id., col. 2:20-27).
  • The Patented Solution: The invention proposes systems and methods to "smooth" the PI measurement to reduce error. One described solution involves calculating PI using at least two different techniques and then determining a final, more accurate PI value by analyzing the results, for instance by selecting the lowest value or performing a statistical analysis ('564 Patent, Abstract; col. 4:27-33). Another solution involves establishing a "baseline PI" during periods of high signal quality and using that baseline to correct or replace measurements taken during periods of noise (Id., col. 3:17-24).
  • Technical Importance: This technology aims to improve the clinical reliability of the perfusion index, a key diagnostic parameter, particularly in environments with patient motion where data integrity is a challenge ('564 Patent, col. 2:18-27).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1 (Compl. ¶119).
  • Essential elements of independent claim 1 include:
    • A method of determining an indication of perfusion index in a patient monitor.
    • Receiving plethysmograph (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.
    • The final indication is determined based on signal quality, the lowest determined value of the at least two indications, an average of the indications, and a statistical analysis of the indications.
  • The complaint asserts claims 1-3, which includes dependent claims (Compl. ¶119).

U.S. Patent No. 8,886,271: "Non-Invasive Physiological Sensor Cover" (Issued Nov. 11, 2014)

The Invention Explained

  • Problem Addressed: The patent notes that physiological sensors are often left attached to monitors even when not actively applied to a patient (U.S. Patent No. 8886271, col. 1:24-28). In this state, the sensor can detect ambient light, leading to false readings and distracting alarms, and is also susceptible to contamination or damage (Id., col. 1:28-45).
  • The Patented Solution: The invention is a cover for the sensor that is configured to block the sensor's light detector from receiving light when the sensor is not in use. The cover is described as being made of an opaque material and may include a protruding, non-adhesive portion (or "tab") to make it easier for a clinician to remove before applying the sensor to a patient ('271 Patent, Abstract; col. 2:5-14).
  • Technical Importance: The invention provides a practical solution to prevent false alarms and reduce sensor contamination in clinical settings, thereby improving workflow efficiency and patient safety ('271 Patent, col. 1:32-35).

Key Claims at a Glance

  • The complaint asserts at least independent claims 1 and 10 (Compl. ¶133, ¶135).
  • Essential elements of independent claim 10 include:
    • A sensor cover for use with a noninvasive optical physiological sensor.
    • An opaque portion attachable to the sensor and configured to block optical readings.
    • A non-adhesive portion that protrudes from the sensor to facilitate removal of the sensor cover.
    • The sensor itself comprises a light source and a detector.
    • The opaque portion is configured to prevent the detector from receiving light during sensor activation.
  • The complaint asserts claims 1-2, 6-11, and 15-18, which includes dependent claims (Compl. ¶133).

U.S. Patent No. 7,295,866: "Low Power Pulse Oximeter" (Issued Nov. 13, 2007)

  • Technology Synopsis: This patent addresses the need for reduced power consumption in portable, battery-operated pulse oximeters (’866 Patent, col. 1:55-61). The invention discloses a system that adaptively samples the physiological signal, such as by reducing the duty cycle of the light-emitting components, to conserve power while being capable of increasing sampling rates to maintain performance during critical events like patient motion or oxygen desaturation ('866 Patent, Abstract).
  • Asserted Claims: Claims 10-12 are asserted, including independent claim 10 (Compl. ¶144).
  • Accused Features: The complaint alleges that the Oxxiom device's emitter driver (Texas Instruments AFE4403) and controller (Nordic Semiconductor nRF51422) are configured to switch between at least two 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 Mar. 6, 2007)

  • Technology Synopsis: This patent addresses the problem that medical sensors require periodic replacement due to wear, damage, or soiling, and that reliance on operators for timely replacement is problematic (’966 Patent, col. 2:6-16). The invention provides a system for automatically tracking the cumulative amount of use of a sensor and activating an indicator, such as a visual alarm or a power-down function, when a predetermined usage limit has been reached to prompt replacement ('966 Patent, Abstract).
  • Asserted Claims: Claims 1, 4, 15, and 19 are asserted, including independent claims 1 and 15 (Compl. ¶157).
  • Accused Features: The complaint alleges that the Oxxiom device and its associated application track the cumulative use of the sensor and, after a predetermined period of twenty-four hours, activate an indication (a red "X" on the application's battery icon) to signal that the probe has expired (Compl. ¶¶159-161).

U.S. Patent No. 10,194,847: "Perfusion Index Smoother" (Issued Feb. 5, 2019)

  • Technology Synopsis: As a member of the same family as the ’564 patent, this patent addresses the same technical problem of inaccurate Perfusion Index (PI) measurements caused by motion noise (’847 Patent, col. 3:5-14). It discloses methods for determining a more reliable PI value by determining first and second indications of amplitude from plethysmograph data and then calculating a final indication based on factors such as signal quality and statistical analysis ('847 Patent, Abstract; col. 4:32-56).
  • Asserted Claims: Claims 1-4 are asserted, including independent claim 1 (Compl. ¶170).
  • Accused Features: The complaint alleges the Oxxiom device and application determine a final PI value by determining first and second amplitude indications from pleth data and then performing a statistical analysis based on a signal quality indication (Compl. ¶174).

U.S. Patent No. 10,194,848: "Non-Invasive Physiological Sensor Cover" (Issued Feb. 5, 2019)

  • Technology Synopsis: As a member of the same family as the ’271 patent, this patent addresses the same issues of preventing false readings and contamination from sensors that are active but not in use (’848 Patent, col. 1:20-32). The invention is a sensor cover system including a cover portion configured to be adhered to the sensor and a protruding portion that facilitates its removal before use ('848 Patent, Abstract).
  • Asserted Claims: All claims (1-29) are asserted, with a specific example provided for claim 9 (Compl. ¶182, ¶184).
  • Accused Features: The Oxxiom device is alleged to include a cover portion that adheres to the sensor and a "protruding portion (Tab '2')" that facilitates removal of the cover before the sensor is applied to a patient (Compl. ¶184). An annotated image from the Oxxiom User Guide is provided to illustrate these components (Compl. ¶184).

III. The Accused Instrumentality

  • Product Identification: The accused instrumentality is the "Oxxiom" pulse oximeter and its corresponding software application, sold by Defendant True Wearables (Compl. ¶4, ¶119).
  • Functionality and Market Context: The Oxxiom is a wearable pulse oximeter designed to noninvasively monitor physiological parameters including arterial oxygen saturation (SpO2), pulse rate (PR), and perfusion index (PI) (Compl. ¶¶121-122). The device contains an optical sensor (Osram SFH7050) with light emitters and a detector, an emitter driver (Texas Instruments AFE4403), and a controller with a Bluetooth transceiver (Nordic Semiconductor nRF51422) (Compl. ¶122, ¶¶146-147). The device communicates with a corresponding application that displays the measured parameters (Compl. ¶121). The complaint alleges the product is intended to compete directly with Plaintiffs' products (Compl. ¶4).

IV. Analysis of Infringement Allegations

8,983,564 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
receiving pleth data The Oxxiom device receives plethysmograph ("pleth") data from a signal received from its optical detector. ¶122 col. 4:11
calculating at least two indications of perfusion index using at least two different calculation techniques When the Oxxiom device is tapped or rubbed while attached to a user, the perfusion index readings allegedly demonstrate the use of at least two different calculation techniques. ¶123 col. 4:27-29
determining a final indication of perfusion index based on the at least two indications... The Oxxiom application displays a resulting, final indication of perfusion index, labeled as "PI," as shown in a screenshot from the True Wearables website. ¶121, ¶123 col. 4:29-30
the final indication determined based on... the lowest determined value of the at least two indications... When the device is tapped or rubbed, it allegedly demonstrates the choice of a calculation technique that results in the lowest perfusion index value. ¶124 col. 4:5-8
  • Identified Points of Contention:
    • Scope Questions: A central question may be whether a user physically "tapping or rubbing" the device, allegedly causing a change in readings, meets the claim limitation of "utilizing... two different calculation techniques." The dispute may focus on whether this is a deliberate, programmatic selection by the device or merely an artifact of a single algorithm processing noisy data.
    • Technical Questions: What evidence supports the allegation that two distinct "calculation techniques" are employed upon tapping the device? The complaint makes this allegation "on information and belief," raising the question of what factual basis exists for this theory of operation.

8,886,271 Infringement Allegations

Claim Element (from Independent Claim 10) Alleged Infringing Functionality Complaint Citation Patent Citation
an opaque portion attachable to the sensor and configured to block optical readings by the sensor The Oxxiom device includes a sensor cover with an opaque portion that is attachable to the sensor and blocks optical readings. ¶135 col. 2:5-7
a non-adhesive portion that protrudes from the sensor to facilitate removal of the sensor cover The sensor cover includes a feature labeled "tab 2," which is described as a non-adhesive portion that protrudes from the sensor to facilitate its removal. ¶135 col. 2:12-14
wherein the sensor comprises a light source... and a detector The Oxxiom device is a sensor containing a light source (multiple LEDs) and a detector within an Osram SFH7050 component. ¶135 col. 1:33-37
wherein the opaque portion is configured to prevent the detector from receiving light during sensor activation The opaque portion of "Tab 2" is shown in instructions to prevent the detector from receiving light during the sensor's activation. An instructional diagram is provided as evidence. ¶135 col. 2:7-9
  • Identified Points of Contention:
    • Scope Questions: The infringement analysis may turn on whether the single-use, integrated adhesive pull-tab on the accused device (labeled "Tab 2") can be construed as a "sensor cover" within the meaning of the claims. The patent specification includes embodiments describing separate, potentially reusable components, which may create a dispute over the intended scope of the term.
    • Technical Questions: Does the "protruding portion" ("Tab 2") meet the "non-adhesive" limitation? While it is designed to be pulled away, it is part of the sensor's overall adhesive backing, which may raise a factual question about its properties and construction.

V. Key Claim Terms for Construction

  • Term from '564 Patent: "utilizing... two different calculation techniques"

    • Context and Importance: This term is critical because the infringement theory rests on the allegation that tapping or rubbing the accused device causes it to switch between different PI calculation methods. The definition will determine whether this alleged behavior constitutes infringement.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification states the processor "utilizes both calculation techniques" or is "configured to select the calculator which calculates the lowest indication," language that does not inherently limit how this utilization or selection must occur (U.S. Patent No. 8,983,564, col. 4:27-33).
      • Evidence for a Narrower Interpretation: Embodiments like FIG. 7 depict a distinct "PI Selector" module (706) that programmatically chooses between outputs of different "PI Calculator" modules (702, 704). This could support an argument that the claim requires a deliberate, algorithmic selection process rather than a passive reaction to external physical stimuli.

  • Term from '271 Patent: "sensor cover"

    • Context and Importance: The viability of the infringement allegation depends on whether the accused product's disposable pull-tab falls within the definition of a "sensor cover."
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The patent's abstract describes a cover that "reduce[s] or eliminate[s] false readings from the sensor when the sensor is not in use," a function served by a pre-use pull-tab ('271 Patent, Abstract). The specification also mentions that the cover can be "removed before placement at a measurement site" (Id., col. 4:10-11).
      • Evidence for a Narrower Interpretation: The specification contains multiple references suggesting reusability, such as "the sensor cover can be reused," "restorable adhesive," and being "reattached once the sensor...is not in use" (Id., col. 4:58-62). Figures 5A-8 depict the cover as a distinct component designed to be attached to a sensor, not as an integrated part of a disposable adhesive backing.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that True Wearables induced infringement of the asserted patents by marketing, selling, and providing directions, manuals, and other materials that instruct customers and end-users on how to use the Oxxiom device in an infringing manner (Compl. ¶¶126, 137, 150, 163, 175, 185).
  • Willful Infringement: Willfulness is alleged based on Defendant Lamego's prior executive roles at Masimo and Cercacor, during which he allegedly had knowledge of Plaintiffs' patent strategy and the specific patent applications that matured into the patents-in-suit (Compl. ¶¶125, 136, 149, 162). The complaint alleges that Defendants knew or should have known their activities would infringe, and that they continued to infringe after becoming aware of the patents, including after the filing of the complaint (Compl. ¶¶129, 140, 153, 166, 178, 188).

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

  • A core issue will be one of definitional scope: can the term "sensor cover," which the patent specification often describes in the context of reusable or re-attachable components, be construed to read on the single-use, integrated adhesive pull-tab of the accused Oxxiom device?
  • A key evidentiary question will be one of functional operation: does the accused device's response to being physically tapped or rubbed constitute the claimed method of "utilizing... at least two different calculation techniques" to determine a perfusion index, or is this merely an artifact of a single algorithm reacting to motion-induced noise?
  • A central theme of the case will be the nexus between the patent infringement claims and the parallel allegations of trade secret misappropriation. The dispute will likely focus on the extent to which Plaintiffs can link the accused infringement to Defendant Lamego’s alleged prior access to confidential information, particularly in establishing the knowledge and intent required for willfulness and indirect infringement.