Fisher & Paykel Healthcare Ltd v. ResMed Ltd

1. Case Identification

• Case #: IPR2017-00504
• Patent #: 9,027,556
• Filed: December 16, 2016
• Petitioner(s): Fisher & Paykel Healthcare Limited
• Patent Owner(s): Resmed Limited
• Challenged Claims: 1-66

2. Patent Overview

• Title: Patient Interface
• Brief Description: The ’556 patent discloses a patient interface system, such as a Continuous Positive Airway Pressure (CPAP) mask, for delivering pressurized gas to a patient. The system comprises a frame module, a cushion module that seals against the patient's face, and an elbow module that connects to an air delivery tube.

3. Grounds for Unpatentability

Ground 1: Claims 1, 2, and 4 are obvious over Matula

• Prior Art Relied Upon: Matula (Application # 2007/0044804).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Matula, which describes a CPAP mask with a faceplate (frame), seal member (cushion), and coupling member (elbow), discloses every limitation of independent claim 1. Specifically, Matula was alleged to teach a frame module, a cushion module with a main body and silicone cushion, a rotatable elbow module, and removable headgear. Petitioner contended that any potential differences were either expressly taught or would have been obvious modifications. For instance, Matula's elbow module connects through a channel with no structure to limit rotation, implying 360° rotation. Matula also teaches interlocking shapes, such as an alignment notch and a ball-and-socket interface, that prevent relative rotation between the frame and cushion.
  • Motivation to Combine (for §103 grounds): This ground is based on a single reference. Petitioner argued that to the extent any minor features were not explicitly disclosed, a person of ordinary skill in the art (POSITA) would have been motivated to make simple modifications to Matula's design to achieve predictable results, such as incorporating a 360° rotating elbow for user convenience and tubing management.
  • Expectation of Success (for §103 grounds): A POSITA would have a high expectation of success in implementing these minor modifications, as they involved applying well-known design principles to a standard CPAP mask structure.

Ground 2: Claims 3, 5, 7, 14-16, 19, 22-26, 29, 32-33, 36, 43, 45-52, 54-55, 57-58, 61-64, and 66 are obvious over Matula in view of Ging

• Prior Art Relied Upon: Matula (Application # 2007/0044804) and Ging (Application # 2005/0155604). Note: This ground also relies on Jaffre (Patent 6,851,425), which Petitioner asserted is incorporated by reference into Matula.
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner asserted that Matula provides the foundational CPAP mask structure, while Ging teaches various additional features recited in the dependent claims. These features include: an anti-asphyxia valve (taught by Jaffre), a swivel joint on the air delivery tube connection (taught by Ging), semi-rigid arms with clip structures for removable headgear attachment (taught by Ging's removable side frame members), and the provision of differently-sized cushion modules with a common interface for modularity (taught by Ging). For example, Ging discloses removable side arms with clip structures and strap-receiving slots, addressing the limitations of claim 5.
  • Motivation to Combine (for §103 grounds): A POSITA would combine the teachings of Ging with Matula to improve the functionality and user-friendliness of Matula’s mask. For instance, adding a swivel joint from Ging would provide greater freedom of movement for the patient. Incorporating removable arms with clips would allow the mask to be disassembled for cleaning without readjusting the headgear straps. Providing differently-sized cushions would allow a single frame to fit a wider range of patients, a common and desirable practice in the field.
  • Expectation of Success (for §103 grounds): Because Matula and Ging both disclose similar CPAP mask assemblies, a POSITA would have reasonably expected success in incorporating Ging’s well-known, modular features into Matula’s basic design to achieve their predictable benefits.

Ground 3: Claims 9-13 are obvious over Matula in view of Namey and Gunaratnam

• Prior Art Relied Upon: Matula (Application # 2007/0044804), Namey (Application # 2002/0020416), and Gunaratnam (Patent 6,796,308).

• Core Argument for this Ground:

  • Prior Art Mapping: This ground focused on the materials and manufacturing methods of the cushion module. Petitioner argued Matula discloses using different materials for the main body (more rigid) and cushion (silicone) and suggests a "two-shot molding" process. Namey was cited for its explicit teaching of a "co-molded" connection using a two-shot injection molding process that creates a molecular bond between a rigid mask body and a softer seal member, without a mechanical interlock. Gunaratnam was cited for teaching the use of polycarbonate as a common, rigid material for mask frames.
  • Motivation to Combine (for §103 grounds): A POSITA would have been motivated to apply the co-molding process of Namey to Matula's mask to reduce the need for adhesives, eliminate manual assembly steps, and create a more reliable seal. The choice to use polycarbonate, as taught by Gunaratnam, for the rigid main body would have been a simple design choice from a short list of well-known, suitable materials known to provide strength, rigidity, and durability for CPAP mask components.
  • Expectation of Success (for §103 grounds): A POSITA would have had a clear expectation of success in using co-molding and polycarbonate, as these were conventional manufacturing techniques and materials used for their known advantages in the CPAP mask industry.

• Additional Grounds: Petitioner asserted additional obviousness challenges based on combinations of Matula, Ging, Melidis (Patent 7,827,990), Lithgow (Application # 2004/0118406), Namey, and Gunaratnam to address the remaining claims, which largely represented laundry lists of the features discussed in the grounds above.

4. Arguments Regarding Discretionary Denial

• Petitioner argued that this petition was not redundant under 35 U.S.C. § 325(d) with respect to another co-pending IPR. Petitioner stated that the other petition was based on a different primary reference (Barnett, Patent 6,412,488), leading to a considerably different obviousness analysis, different prior art combinations, and distinct reasons for combining the references.

5. Relief Requested

• Petitioner requests institution of an inter partes review and cancellation of claims 1-66 of the ’556 patent as unpatentable.