PTAB

IPR2020-00967

Sotera Wireless Inc v. Masimo Corp

Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: ALARM SUSPEND SYSTEM
  • Brief Description: The ’244 patent discloses a physiological measurement system that monitors multiple parameters, such as oxygen saturation (SpO2) and pulse rate (PR). The system is configured to manage alarms by initiating a parameter-specific alarm delay or suspension period when a measurement satisfies an alarm threshold.

3. Grounds for Unpatentability

Ground 1: Claims 1, 6-8, 13-14, 18-19, and 23-26 are obvious over Baker-1.

  • Prior Art Relied Upon: Baker-1 (Patent 5,865,736).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Baker-1 discloses a system for reducing nuisance alarms in medical diagnostic apparatus, such as pulse oximeters. It teaches using separate, distinct integral algorithms for both SpO2 and PR, where an alarm is inhibited based on a combination of the amount of time a parameter is past a threshold and the amount by which it exceeds it. This method inherently creates parameter-specific pre-alarm delay periods; an alarm is generated only after an integral value (based on time and severity) exceeds an integral threshold. The duration of the delay for an SpO2 alarm is thus different from the delay for a PR alarm.
    • Motivation to Combine (for §103 grounds): To the extent Baker-1 does not explicitly teach a single device with both SpO2 and PR integral algorithms, Petitioner asserted a POSITA would combine them. The motivation stems from the fact that pulse oximeters conventionally monitor both crucial parameters, and applying the same nuisance alarm reduction technique to both would be a predictable improvement.
    • Expectation of Success (for §103 grounds): A POSITA would have had a high expectation of success, as it involves applying a known algorithm to a second, commonly measured parameter on the same device to achieve a predictable reduction in false alarms.

Ground 2: Claims 1-2, 6-9, 13-15, and 18-26 are obvious over Baker-1 in view of Batchelder.

  • Prior Art Relied Upon: Baker-1 (Patent 5,865,736) and Batchelder (Application # 2009/0247851).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground built upon Ground 1, adding Batchelder to explicitly teach features Petitioner asserted were implicit in Baker-1. Batchelder discloses a graphical user interface for a pulse oximetry monitor that allows a user to adjust both the alarm threshold (e.g., SpO2 level) and an alarm integration threshold (e.g., "SatSeconds"). Petitioner argued that changing these values via the interface directly alters the resulting pre-alarm delay time, thus explicitly teaching user-selectable elements that correspond to a plurality of parameter-specific alarm delay periods.
    • Motivation to Combine (for §103 grounds): A POSITA would combine Batchelder's user interface with Baker-1's system to gain the known advantage of enabling a caregiver to customize alarm settings for a specific patient and condition. This combination was presented as a predictable integration of a user interface with an underlying alarm-processing system to yield the expected result of user-adjustable alarm delays.

Ground 3: Claims 1-2, 6-9, 13-15, and 18-26 are obvious over Saidara in view of Malangi.

  • Prior Art Relied Upon: Saidara (Application # 2005/0038332) and Malangi (a 2003 thesis from New Jersey Institute of Technology).

  • Core Argument for this Ground:

    • Prior Art Mapping: This ground addressed the alternative claim construction of a "post-alarm suspension." Petitioner argued Saidara teaches a system that monitors physiological characteristics (including blood glucose and SpO2) and uses an "alarm repeat delay period" to temporarily prevent subsequent alarms after a first alarm is triggered. Saidara discloses different delay periods for different severities of the same parameter (e.g., hypoglycemia vs. hyperglycemia). To the extent Saidara does not explicitly provide suspension times for different parameters, Malangi teaches a system with different alarm "silence times" for different blood pressure (BP) alarm conditions based on their priority and severity.
    • Motivation to Combine (for §103 grounds): A POSITA would be motivated to modify Saidara's system to incorporate the teachings of Malangi to create a comprehensive multi-parameter monitor. The combination would predictably apply different, known suspension periods to different measured parameters (e.g., SpO2 from Saidara, BP from Malangi) based on severity to prevent caregiver distraction while still providing intermittent warnings.
  • Additional Grounds: Petitioner asserted additional obviousness challenges, including combining Baker-1 and Batchelder with Baker-2 (Patent 8,792,949) to add pre-set alarm delays, and adding Hickle (Application # 2003/0135087) to any combination to teach a pop-up window interface.

4. Key Claim Construction Positions

  • Petitioner argued that the parties dispute the scope of the term "alarm delay or suspension period of time."
  • Petitioner contended that, based on the ’244 patent's specification which only teaches suspending active alarms, the term should be narrowly construed as a "post-alarm suspension" (like a snooze button).
  • However, Petitioner acknowledged that the Patent Owner construes the term more broadly to also cover "pre-alarm delays" (an "annunciation delay" that is part of the alarm threshold itself). Petitioner asserted the claims were invalid under either construction and therefore presented separate grounds for each interpretation (Grounds 1-4 for pre-alarm delays, Grounds 5-6 for post-alarm suspensions).

5. Arguments Regarding Discretionary Denial

  • Petitioner argued against discretionary denial under §325(d), asserting that the primary prior art and arguments in the petition were not previously presented to or considered by the USPTO.
  • For the "pre-alarm delay" theory (Grounds 1-4), Petitioner stated that the core references, Baker-1 and Batchelder, were never considered by the Examiner during prosecution.
  • For the "post-alarm suspension" theory (Grounds 5-6), Petitioner argued that its proposed combination of Saidara and Malangi is substantially different from the Gibson/Saidara combination the Examiner reviewed. Petitioner contended its combination teaches parameter-specific suspension times for different parameters based on severity, whereas the Examiner was only presented with a combination resulting in different suspension times for a single parameter.

6. Relief Requested

  • Petitioner requested institution of an inter partes review and cancellation of claims 1-26 of the ’244 patent as unpatentable under 35 U.S.C. §103.