Apple Inc. v. Masimo Corporation

1. Case Identification

• Case #: IPR2024-00290
• Patent #: 8,190,223
• Filed: December 12, 2023
• Petitioner(s): Apple Inc.
• Patent Owner(s): Masimo Corporation
• Challenged Claims: 1-4, 6, 11-22, 27-28, 32, 34, 36-37, and 42-44

2. Patent Overview

• Title: Noninvasive Multi-Parameter Patient Monitor
• Brief Description: The ’223 Patent relates to patient monitors that display measurements derived from optical sensors. The core invention involves a display capable of showing multiple physiological parameters, where the display of one parameter is replaced by another based on an event, such as a parameter approaching a threshold indicative of a worsening patient state.

3. Grounds for Unpatentability

Ground 1A: Obviousness over Naghavi, Hochstedler, and Burnes - Claims 1-4, 6, 11-18, and 20-22 are obvious over Naghavi in view of Hochstedler and Burnes.

• Prior Art Relied Upon: Naghavi (Application # 2002/0184055), Hochstedler (Patent 6,707,476), and Burnes (Application # 2006/0064020).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Naghavi taught a personal healthcare management system with a graphical user interface (GUI) that acquires data from medical sensors and can change its display (e.g., icon color, shape, order) based on the severity of a patient's condition. Hochstedler taught a patient monitoring system GUI with configurable layouts composed of "parameter blocks" for displaying real-time vital signs. It explicitly disclosed automatically switching between layouts to display different parameter blocks. Burnes taught a patient monitoring GUI that categorizes parameter values based on predefined thresholds (e.g., "out of range," "near out of range") and triggers automatic display changes, such as alarms or visual highlighting, when these thresholds are crossed. Petitioner contended that combining these references would result in a patient monitor meeting the limitations of independent claims 1, 13, 15, 18, and 21, which require replacing one parameter display with another in a common display area based on an event indicative of a worsening patient state.
  • Motivation to Combine: A POSITA would combine these references to implement Naghavi's flexible health management system with the specific, well-understood GUI layouts from Hochstedler. Burnes would be incorporated to provide a known method for triggering display changes based on clinically relevant events (parameters crossing thresholds), which Naghavi generally contemplated. This combination would predictably improve the display of clinically relevant information, relieve data analysis burden on clinicians, and was merely an application of known techniques to a known system.
  • Expectation of Success: Success was predictable because integrating known display techniques (layout switching, threshold-based alerts) into a standard medical monitoring device was a conventional and well-understood design choice.

Ground 1B: Obviousness over Naghavi, Hochstedler, Burnes, and Hayashi - Claims 19, 27-28, 32, 34, 36-37, and 42-43 are obvious over the combination of Ground 1A in view of Hayashi.

• Prior Art Relied Upon: Naghavi (Application # 2002/0184055), Hochstedler (Patent 6,707,476), Burnes (Application # 2006/0064020), and Hayashi (Patent 6,151,518).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground builds on the combination in Ground 1A by adding Hayashi, which described a non-invasive instrument for measuring blood constituents (e.g., oxyhemoglobin, carboxyhemoglobin) using a light source and a light-sensitive optical detector that measures light attenuated by body tissue. Petitioner argued that incorporating Hayashi's optical sensor technology into the patient monitor of Ground 1A would render obvious the limitations of claims 19, 27, and 28, which require determining physiological parameters from an output signal of a light-sensitive detector. Dependent claims for storing trend data (claim 34) and providing alarms (claims 36-37) were argued to be taught by the base combination.
  • Motivation to Combine: A POSITA would be motivated to add Hayashi's technology to the base combination to gain the clinical utility of monitoring specific blood constituents, which provides more detailed, actionable information about a patient's oxygenation status. Using non-invasive optical methods as taught by Hayashi was a known, low-risk, and advantageous way to monitor such parameters.
  • Expectation of Success: Success was expected because monitoring blood constituents was common, and both Naghavi and Hochstedler described flexible systems designed to incorporate various types of sensors and display their data.

Ground 1C: Obviousness over Naghavi, Hochstedler, Burnes, Hayashi, and Mortz - Claims 32 and 42-44 are obvious over the combination of Ground 1B in view of Mortz.

• Prior Art Relied Upon: Naghavi (Application # 2002/0184055), Hochstedler (Patent 6,707,476), Burnes (Application # 2006/0064020), Hayashi (Patent 6,151,518), and Mortz (Patent 6,385,471).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground builds on the combination in Ground 1B by adding Mortz, which described a pulse oximeter probe that computes and displays pulse rate. Petitioner argued that adding a common pulse rate sensor, as taught by Mortz, to the multi-parameter monitor of Ground 1B would render obvious the limitations of claim 42, which requires a second display capable of displaying a pulse rate. Dependent claims 43 and 44, which require displaying the pulse rate on the second display while the first displays a blood parameter, were argued to be an obvious implementation for concurrently presenting multiple data types.
  • Motivation to Combine: A POSITA would be motivated to include pulse rate monitoring as taught by Mortz due to its significant clinical advantages for early warning of medical issues. Pulse oximeters were common, simple, and inexpensive. Incorporating this functionality into a multi-parameter monitor was a predictable improvement.
  • Expectation of Success: A POSITA would have expected success because patient monitoring systems with pulse oximetry were common, and the base system from Naghavi and Hochstedler was explicitly flexible regarding sensor inputs.

4. Arguments Regarding Discretionary Denial

• Petitioner argued that discretionary denial under 35 U.S.C. §314(a) based on Fintiv factors would be inappropriate. The petition asserted that a Final Written Decision (FWD) would issue months before any potential trial in the parallel district court litigation, whose trial date is not yet set and is statistically unlikely to occur before mid-2025. Petitioner also presented a comprehensive stipulation, promising not to pursue in the district court any invalidity ground that utilizes any of the prior art asserted in the IPR, thereby eliminating overlap between the proceedings.
• Petitioner also argued against denial under §325(d), contending that the primary prior art references (Naghavi, Hochstedler, Burnes) were never applied or discussed by the examiner during prosecution, and thus the petition raises art and arguments not previously considered by the USPTO.

5. Relief Requested

• Petitioner requests institution of an inter partes review and cancellation of claims 1-4, 6, 11-22, 27-28, 32, 34, 36-37, and 42-44 of the ’223 patent as unpatentable.