Sotera Wireless Inc v. Masimo Corp

1. Case Identification

• Case #: IPR2020-01033
• Patent #: RE47,249
• Filed: June 3, 2020
• Petitioner(s): Sotera Wireless, Inc.
• Patent Owner(s): Masimo Corporation
• Challenged Claims: 1-24

2. Patent Overview

• Title: ALARM SUSPEND SYSTEM
• Brief Description: The ’249 patent relates to a physiological monitoring system that activates an alarm when a parameter, such as oxygen saturation (SpO2), exceeds a predetermined threshold. The system allows a user to temporarily hold or suspend an alarm for a parameter-specific period of time, after which the alarm may reactivate if the triggering condition persists.

3. Grounds for Unpatentability

Ground 1: Obviousness over Baker-1 and Batchelder - Claims 1-2, 6-9, 13-15, and 18-24 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: Petitioner argued that Baker-1 teaches a method for reducing nuisance alarms in physiological monitors by delaying alarm activation until an integral value, representing a combination of the amount and duration by which a parameter exceeds a threshold, is reached. Baker-1 discloses distinct integral algorithms for both SpO2 and pulse rate (PR), resulting in different, parameter-specific alarm delay periods. To the extent Baker-1 does not explicitly teach that a user can adjust the thresholds to alter these delay periods, Batchelder supplies this element. Batchelder discloses a graphical user interface that allows a user to adjust alarm thresholds (e.g., SpO2 and "SatSeconds" integration thresholds), which explicitly changes the resulting alarm delay times.
  • Motivation to Combine: A POSITA would combine Batchelder's user-adjustable interface with the system of Baker-1 to achieve the predictable result of enabling a caregiver to customize alarm sensitivity for a particular patient. This combination would leverage the known advantages of reducing false alarms while ensuring patient safety through tailored monitoring.
  • Expectation of Success: The combination would predictably yield a system with user-adjustable, parameter-specific alarm delays, as both references operate in the same field of pulse oximetry and address the same problem of nuisance alarms.

Ground 2: Obviousness over Baker-1, Batchelder, and Baker-2 - Claims 1-2, 6-9, 13-15, and 18-24 are obvious over Baker-1 and Batchelder in view of Baker-2.

• Prior Art Relied Upon: Baker-1 (Patent 5,865,736), Batchelder (Application # 2009/0247851), and Baker-2 (Patent 8,792,949).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground builds on the combination of Baker-1 and Batchelder. Petitioner argued that if the challenged claims are interpreted to require pre-set "alarm hold periods of time," Baker-2 teaches this feature. Baker-2 discloses reducing nuisance alarms by delaying an alarm based on measurement accuracy, where the delay period "may be selected from one or more predetermined delay periods." For example, if a calculated accuracy is within a certain range, a predetermined 5-second delay may be used.
  • Motivation to Combine: A POSITA would be motivated to substitute the dynamically calculated alarm delays of the Baker-1/Batchelder system with the pre-set delay periods taught in Baker-2. This would be a simple substitution of one known method for another to achieve the same predictable result—nuisance alarm reduction—while providing the added clinical advantage of more predictable alarm behavior.
  • Expectation of Success: Incorporating pre-set delay times into the Baker-1/Batchelder system would have been straightforward, as it represents choosing from a finite number of known and predictable solutions for alarm management.

Ground 3: Obviousness over Saidara and Malangi - Claims 1-2, 6-9, 13-15, and 18-24 are obvious over Saidara in view of Malangi.

• Prior Art Relied Upon: Saidara (Application # 2005/0038332) and Malangi (a 2003 thesis on computer-assisted resuscitation algorithms).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground addresses a "post-alarm suspension" interpretation of the claims. Petitioner asserted that Saidara discloses a system that, after an initial alarm, prevents subsequent alarms for a user-selectable "alarm repeat delay period." Saidara teaches different sets of selectable delay periods for different conditions (e.g., hypoglycemia vs. hyperglycemia), thereby disclosing parameter-specific alarm suspensions. Malangi teaches silencing alarms in a blood pressure (BP) monitor for different, pre-set time periods based on the severity of the specific alarm condition (e.g., a "Falling Patient BP" alarm has a 2-minute silence time, while a less severe alarm has a 5-minute time).
  • Motivation to Combine: A POSITA would modify Saidara's system, which already contemplates monitoring multiple parameters like SpO2, to incorporate the parameter-specific alarm silence features of Malangi for parameters like BP. Combining the references would predictably result in a multi-parameter monitor applying known, differing suspension periods based on the specific parameter and its severity, a well-known method to improve patient monitoring and reduce caregiver distraction.
  • Expectation of Success: Combining the teachings would have predictably yielded a multi-parameter monitor with parameter-specific alarm suspension times, as both references teach applying different time delays based on the nature and severity of physiological events.
• Additional Grounds: Petitioner asserted additional obviousness challenges, including combinations with Hickle (Application # 2003/0135087) for its teaching of user-friendly pop-up windows for alarm settings.

4. Key Claim Construction Positions

• The petition identified the term "alarm hold period of time" as the central disputed term. Petitioner argued that the patent owner asserts in co-pending litigation that this term covers pre-alarm delays (where alarm activation is held off until a condition persists). Petitioner contended the term should be limited by the specification to its only disclosed embodiment: post-alarm suspensions (where an already active alarm is temporarily silenced). The petition advanced invalidity arguments under both interpretations, with Grounds 1-4 directed at the pre-alarm delay construction and Grounds 5-6 at the post-alarm suspension construction.

5. Arguments Regarding Discretionary Denial

• Petitioner argued against discretionary denial under 35 U.S.C. §325(d), asserting that the prior art and arguments presented were not substantially the same as those considered during prosecution.
• For Grounds 1-4, Petitioner stated the primary references (Baker-1, Batchelder, Baker-2) teach pre-alarm delays, a concept materially different from the post-alarm suspension art the Examiner considered. These key references were either not before the Examiner or not substantively reviewed.
• For Grounds 5-6, Petitioner argued that while Saidara was previously considered, it was only as a secondary reference. The petition's new combination of Saidara (as primary) with Malangi (never considered) presents a stronger, more direct case for obviousness and constitutes a different argument than that reviewed by the Examiner, who also allegedly erred in his initial evaluation of Saidara.

6. Relief Requested

• Petitioner requests institution of an inter partes review and cancellation of claims 1-24 of Patent RE47,249 as unpatentable.