PTAB

IPR2017-00062

Fisher & Paykel Healthcare Ltd v. ResMed Ltd

Log In
Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: CPAP Mask System
  • Brief Description: The ’931 patent relates to continuous positive airway pressure (CPAP) mask systems for treating sleep-disordered breathing. The disclosed systems include a cushion module with a frame and seal, a shroud module that connects to headgear, and an elbow for air delivery.

3. Grounds for Unpatentability

Ground 1: Obviousness over D'Souza, Ultra Mirage, Barnett, and Matula-II - 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 (a ResMed product brochure), Barnett (Patent 6,412,488), and Matula-II (Application # 2007/0044804).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that the prior art collectively discloses all limitations of the challenged claims. D’Souza was asserted to teach the core two-part mask assembly, comprising a shroud module (skeleton frame) and a cushion module that removably interlock via a snap-fit mechanism. To address features not explicitly in D’Souza, Petitioner contended that Ultra Mirage, a commercial mask, teaches a protruding vent arrangement at the nasal bridge for CO2 washout and removable headgear clips for user convenience. Barnett was cited for its disclosure of a 360-degree rotatable elbow attached to the mask frame to provide control over tubing. Finally, Matula-II was argued to teach specific features for improving the mask's seal and connection, including one or more folds in the nasal bridge portion of the cushion for flexibility and a plurality of snap-fingers for a more robust snap-fit connection.
    • Motivation to Combine: A POSITA would combine these references to incorporate well-known, desirable features into D'Souza's basic mask design. The motivation was to improve user convenience (rotatable elbow, removable clips), therapeutic efficacy (CO2 washout vent), comfort (flexible cushion folds), and manufacturability by using known connection methods (snap-fingers). All references address common problems in the same field of CPAP mask design.
    • Expectation of Success: A POSITA would have an expectation of success because combining these simple mechanical components from other CPAP masks would involve predictable design choices and yield predictable results.

Ground 2: Obviousness over D'Souza, Ultra Mirage, Barnett, Matula-II, and FlexiFit - Claim 60 is obvious over the combination of prior art in Ground 1 in view of FlexiFit.

  • Prior Art Relied Upon: D’Souza (WO 2007/041751), Ultra Mirage (brochure), Barnett (Patent 6,412,488), Matula-II (Application # 2007/0044804), and FlexiFit (a Fisher & Paykel product manual).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground built upon the combination in Ground 1, adding FlexiFit to teach the specific headgear connector limitations of claim 60. Petitioner argued that FlexiFit discloses upper headgear connectors that include slots for receiving headgear straps, a common and simple design choice. It also teaches removable lower headgear clips, similar to Ultra Mirage, reinforcing that this was a known feature.
    • Motivation to Combine: A POSITA would be motivated to incorporate the slotted connectors from FlexiFit as a simpler and more cost-effective design alternative for attaching upper straps compared to clip mechanisms. Using clips for lower straps, which are under more tension when donning the mask, while using simpler slots for upper straps, was presented as a known and logical design trade-off to simplify manufacturing and reduce parts.
    • Expectation of Success: Incorporating a known strap attachment method (slots) into the mask assembly of D'Souza/Ultra Mirage was argued to be a straightforward modification with predictable results.

Ground 3: Obviousness over D'Souza, Ultra Mirage, Barnett, Matula-II, FlexiFit, and Jaffre - Claims 43, 48-50, and 70 are obvious over the combination of prior art in Ground 2 in view of Jaffre.

  • Prior Art Relied Upon: All references from Ground 2, plus Jaffre (Patent 6,851,425).

  • Core Argument for this Ground:

    • Prior Art Mapping: This ground added Jaffre to teach features of the air delivery elbow recited in claims 43 and 70. Petitioner asserted that while Ultra Mirage and Barnett teach a rotatable elbow, Jaffre specifically discloses an anti-asphyxia valve (AAV) within the elbow. The AAV in Jaffre includes a flap portion that selectively closes a port, allowing a patient to breathe ambient air if the CPAP flow generator fails. Ultra Mirage was also cited for teaching an elbow with a "quick release swivel," which Petitioner mapped to the swivel limitation.
    • Motivation to Combine: A POSITA would combine Jaffre's AAV with the rotatable, swiveling elbow of Ultra Mirage/Barnett to enhance patient safety. Providing an AAV was a known safety feature in CPAP masks to prevent rebreathing of CO2 and asphyxiation during a power failure. Integrating this known safety feature into the D'Souza mask design would have been a common-sense improvement.
    • Expectation of Success: Adding a known safety valve like the one in Jaffre to a standard CPAP elbow was argued to be a routine and predictable modification for a POSITA.

  • Additional Grounds: Petitioner asserted additional obviousness challenges, including grounds adding Gunaratnam-II (Application # 2004/0226566) to teach specific headgear configurations, such as adjustable buckles for top straps and a closed-loop design. These grounds relied on similar motivations to combine known features for improved fit, stability, and user adjustment.

4. Arguments Regarding Discretionary Denial

  • Petitioner argued that this petition was not redundant under 35 U.S.C. §325(d) despite the concurrent filing of three other IPR petitions against the same ’931 patent. Petitioner contended that the petitions were necessary because they challenge different sets of claims or rely on different primary prior art references (e.g., D'Souza vs. Barnett). This strategy was employed to preemptively address potential arguments from the Patent Owner regarding the prior art status of D'Souza, which might be subject to a "swearing behind" challenge, whereas a reference like Barnett would not be.

5. Relief Requested

  • Petitioner requests institution of an inter partes review and cancellation of claims 43, 46, 48-51, 53-58, 60-65, 68-71, and 77-79 of the ’931 patent as unpatentable.