PTAB

IPR2017-00062

Fisher & Paykel Healthcare Limited v. ResMed Limited

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1. Case Identification

2. Patent Overview

  • Title: CPAP Mask Systems
  • Brief Description: The ’931 patent relates to Continuous Positive Airway Pressure (CPAP) mask systems used for treating sleep-disordered breathing. The disclosed systems include a seal that contacts the patient's face, a frame that supports the seal, and headgear to hold the assembly in place on the patient.

3. Grounds for Unpatentability

Ground 1: Claims 57, 58, 61, 65, 68, 69, 71, and 77–79 are obvious over D’Souza in view of Ultra Mirage, Barnett, and Matula-II.

  • Prior Art Relied Upon: D’Souza (WO 2007/041751), Ultra Mirage (Ultra Mirage Full Face Mask Brochure), Barnett (Patent 6,412,488), and Matula-II (Application # 2007/0044804).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that D’Souza, a prior art publication by the Patent Owner, disclosed the core mask assembly of independent claim 57, including a two-part system with a shroud module and a cushion module adapted to removably interlock. Ultra Mirage was cited to teach known features like upper headgear connectors and a 360° rotating elbow. Barnett was also cited for its disclosure of a rotatable elbow. Matula-II was cited to teach specific cushion features, such as a flexible fold in the nasal bridge region for adaptability, and a plurality of snap fingers to create a secure snap-fit connection.
    • Motivation to Combine: A POSITA would be motivated to combine these known features from the CPAP mask art to improve the functionality of the D'Souza mask assembly. Adding a rotatable elbow (Ultra Mirage, Barnett) is a known solution for better tubing management, adding flexible folds to a cushion (Matula-II) is a known way to improve fit and comfort, and using snap fingers (Matula-II) is a common method for creating a robust, removable connection.
    • Expectation of Success: Because all references relate to CPAP mask components, a POSITA would have had a reasonable expectation of success in combining these known mechanical elements, as their function in the combined system would be predictable.

Ground 2: Claim 60 is obvious over D’Souza in view of Ultra Mirage, Barnett, Matula-II, and FlexiFit.

  • Prior Art Relied Upon: D’Souza (WO 2007/041751), Ultra Mirage (Ultra Mirage Full Face Mask Brochure), Barnett (Patent 6,412,488), Matula-II (Application # 2007/0044804), and FlexiFit (FlexiFit Series, HC 431 Full Face Mask, Instructions for Use).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground built upon Ground 1 by adding FlexiFit to address the specific headgear attachment limitations of dependent claim 60. Petitioner argued that FlexiFit taught the claimed features of upper headgear connectors including a slot for a strap, and lower headgear connectors adapted to interlock with removable headgear clips.
    • Motivation to Combine: A POSITA would combine the headgear attachment methods of FlexiFit with the D'Souza mask assembly to improve usability. Using removable clips for the lower straps, as taught by FlexiFit, would allow a user to more easily position and remove the mask without the difficulty of pulling tensioned straps over the head. Using a simple slot for the upper straps was presented as a known design choice that would simplify manufacturing.
    • Expectation of Success: The combination of these standard headgear features with a mask assembly was argued to be a predictable and straightforward design modification.

Ground 3: Claims 62–64 are obvious over D’Souza in view of Ultra Mirage, Barnett, Matula-II, FlexiFit, and Gunaratnam-II.

  • Prior Art Relied Upon: D’Souza (WO 2007/041751), Ultra Mirage, Barnett, Matula-II, FlexiFit, and Gunaratnam-II (Application # 2004/0226566).

  • Core Argument for this Ground:

    • Prior Art Mapping: This ground added Gunaratnam-II to the previous combination to teach the specific headgear configurations recited in claims 62-64. FlexiFit was cited for teaching the overall headgear structure, including upper straps splitting into top crown and rear straps that form a closed loop around the back of the head. FlexiFit also disclosed flexible straps providing padding. Gunaratnam-II was cited to teach the use of a buckle to removably and adjustably couple the top straps.
    • Motivation to Combine: A POSITA would combine these headgear features to create a stable, comfortable, and easily adjustable mask system. The closed-loop design taught by FlexiFit provides stability, while the buckle taught by Gunaratnam-II provides a well-known mechanism for adjusting strap length and securing the headgear.
    • Expectation of Success: Integrating a known headgear design with a buckle for adjustment onto the D'Souza mask frame was argued to be a simple and predictable substitution of known elements.

  • Additional Grounds: Petitioner asserted additional obviousness challenges against claims 43, 46, 48-51, and 53-70. These grounds relied on the same core combination of D'Souza, Ultra Mirage, Barnett, Matula-II, and FlexiFit, but added Jaffre (Patent 6,851,425) to teach an elbow including an anti-asphyxia valve with a flap portion.

4. Arguments Regarding Discretionary Denial

  • Petitioner argued that the Board should not exercise discretionary denial under 35 U.S.C. §325(d) because this petition is not redundant with other co-pending IPRs filed against the same patent. Petitioner explained that the concurrent petitions challenge different sets of claims or rely on different prior art combinations. Specifically, Petitioner noted that another of its petitions relies on Barnett as the primary reference, which is indisputable prior art under §102(b), whereas this petition's primary reference, D'Souza, could be subject to an attempt by the Patent Owner to "swear behind" it. Requesting review on both grounds was argued to be a necessary precaution to ensure a complete review of the patent's validity.

5. Relief Requested

  • Petitioner requests institution of IPR and cancellation of claims 43, 46, 48-51, 53-58, 60-65, 68-71, and 77-79 as unpatentable.