Fisher & Paykel Healthcare Limited v. ResMed Limited

1. Case Identification

• Case #: IPR2017-01789
• Patent #: 8,960,196
• Filed: July 14, 2017
• Petitioner(s): Fisher & Paykel Healthcare Limited
• Patent Owner(s): Resmed Limited
• Challenged Claims: 1-22

2. Patent Overview

• Title: Mask System with Interchangeable Headgear Connectors
• Brief Description: The ’196 patent relates to a mask system for treating sleep-disordered breathing. The system includes a common mask frame and at least two different headgear connectors that can be removably attached to the frame, allowing for patient customization.

3. Grounds for Unpatentability

Ground 1: Obviousness over Ogden, Gunaratnam, and Amarasinghe - Claims 1-3, 6, 7, and 9-22 are obvious over Ogden in view of Gunaratnam and Amarasinghe.

• Prior Art Relied Upon: Ogden (Patent 5,662,101), Gunaratnam (Patent 6,796,308), and Amarasinghe (Application # 2004/0065328).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Ogden disclosed the core structure of independent claim 1: a CPAP mask with a mask frame (rigid shell 3), a separate and removable headgear connector (rigid plate 9), a sealing cushion, and a forehead support. To the extent Ogden did not explicitly teach clip-based headgear attachments or the use of multiple, different headgear connectors, Gunaratnam disclosed lower headgear clip anchors and clips, while Amarasinghe taught providing a user with multiple, interchangeable braces (headgear connectors) for use with a single mask shell to accommodate different patient preferences.
  • Motivation to Combine: A Person of Ordinary Skill in the Art (POSITA) would combine these references to improve upon Ogden’s design. A POSITA would incorporate Gunaratnam’s well-known headgear clips for user convenience, avoiding the need to pull tight straps over the head. A POSITA would also have been motivated by Amarasinghe to provide multiple connector options with different shapes or attachment points for a single frame, allowing patients to choose a preferred fit without purchasing entirely new mask assemblies.
  • Expectation of Success: The combination involved simple, compatible mechanical components common in CPAP masks. A POSITA would have a reasonable expectation of success in integrating known clip features and offering modular connector options, as these were known methods for enhancing user comfort and convenience that would yield predictable results.

Ground 2: Obviousness over Ogden, Gunaratnam, Amarasinghe, and Lovell - Claims 4, 5, and 8 are obvious over Ogden in view of Gunaratnam, Amarasinghe, and Lovell.

• Prior Art Relied Upon: Ogden (Patent 5,662,101), Gunaratnam (Patent 6,796,308), Amarasinghe (Application # 2004/0065328), and Lovell (Patent 6,631,718).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground built upon Ground 1, adding Lovell to teach the limitations of dependent claims 4, 5, and 8. Lovell was cited to teach a headgear connector shaped to conform to the mask frame (claim 4), a mask frame with a peripheral edge for engaging the connector (claim 5), and a non-movable attachment between the frame and connector (claim 8). Petitioner argued that while Ogden's connector pivots, Lovell taught a fixed, non-movable snap-fit connection.
  • Motivation to Combine: A POSITA would have been motivated to incorporate Lovell's teachings to improve the stability and profile of the Ogden mask. Conforming the connector to the frame, as taught by Lovell, would reduce the mask's profile and likelihood of snagging on bedding. A POSITA would also adopt Lovell's non-movable connection to provide a more stable seal, recognizing that any benefit of Ogden's pivoting feature was outdated by advances in cushion design.
  • Expectation of Success: Modifying the Ogden design to include a conforming, non-movable connection as taught by Lovell was a straightforward mechanical integration. A POSITA would expect success in creating a more stable and reliable mask assembly.

Ground 3: Obviousness over Gunaratnam, Lovell, and Amarasinghe - Claims 1-22 are obvious over Gunaratnam in view of Lovell and Amarasinghe.

• Prior Art Relied Upon: Gunaratnam (Patent 6,796,308), Lovell (Patent 6,631,718), and Amarasinghe (Application # 2004/0065328).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground used Gunaratnam as the primary reference, arguing it disclosed a mask assembly nearly identical to the ’196 patent but with a unitary frame and headgear connector. Petitioner contended that the key inventive concept—separating the unitary piece into a distinct mask frame and headgear connector—was obvious in view of Lovell, which explicitly taught separate frame and connector components. Amarasinghe was again relied upon to teach the use of multiple, different connectors with the same frame.
  • Motivation to Combine: A POSITA would be motivated to divide Gunaratnam's unitary frame into two separate parts as taught by Lovell for improved hygiene and usability. This modification would create a removable breathing chamber (frame and cushion) that could be cleaned without detaching the entire headgear apparatus, preserving strap adjustments. A POSITA would then incorporate Amarasinghe’s teaching of multiple connectors to provide patient-specific options for this improved modular design.
  • Expectation of Success: Dividing a single plastic component into two interlocking pieces was a well-known design choice. A POSITA would have a high expectation of success in applying the modular design of Lovell to the Gunaratnam mask to achieve the predictable benefits of easier cleaning and component replacement.

4. Key Claim Construction Positions

• "central bore": Petitioner argued that under a broadest reasonable interpretation, Ogden's bore is "central" as it is located on the horizontal axis of the mask and aligned with the patient's nose. To the extent the term is construed more narrowly to require centering in all dimensions, Petitioner contended it would have been an obvious modification to center the bore to better distribute hose-pull forces and allow 360° swivel.
• "forehead support": Petitioner argued that to the extent this term is narrowly interpreted to require direct contact with the user's forehead (which Ogden's support may not do), it was a well-known feature. A POSITA would have been motivated to modify Ogden's support to contact the forehead, as taught by Gunaratnam, to add a second point of contact for greater stability.

5. Arguments Regarding Discretionary Denial

• Petitioner argued that the Board should not exercise its discretion to deny institution under §314(a) or §325(d). The petition asserted that it was not redundant with prior IPRs filed against the ’196 patent because this petition challenges a different set of claims (1-22 versus 23-86). Furthermore, this petition relied on new prior art (Amarasinghe) not used in the previous petitions to address limitations unique to the challenged claims, specifically the use of multiple, different headgear connectors. Petitioner characterized this filing as a first, necessary challenge to unasserted claims, not an improper "follow-on" petition or an attempt to take "multiple bites at the apple."

6. Relief Requested

• Petitioner requests institution of an inter partes review and cancellation of claims 1-22 of the ’196 patent as unpatentable.