ResMed brings infringement suit over sleep apnea treatment devices

Figure 1 from U.S. Patent No. 9,027,556.

Figure 1 from U.S. Patent No. 9,027,556.

On Wednesday, August 17th, respiratory health device developer ResMed Inc. (NYSE:RMD) of San Diego, CA, announced that it had filed multiple legal actions against Fisher & Paykel Healthcare (NZE:FPH) of Auckland, New Zealand. ResMed is alleging that multiple Fisher & Paykel products are infringing upon multiple patents and is seeking an injunction banning the importation of those products. ResMed filed actions with the U.S. International Trade Commission (ITC) and the U.S. District Court for the Southern District of California (S.D. Cal.) as well as courts in Germany and New Zealand.

ResMed argues that Fisher & Paykel is infringing upon patents it holds related to modular mask systems, headgear design and cushion design with products such as the Simplus full face mask for sleep apnea patients. ResMed is also targeting the Eson and Eson 2 nasal masks marketed by Fisher & Paykel. The devices are designed to provide therapeutic benefits to sleep apnea patients while allowing full motion of the head for comfortable sleep.

ResMed is attempting to assert its rights on four patents in its portfolio:

  • cushionU.S. Patent No. 8944061, which is titled Cushion to Frame Assembly Mechanism. It protects a mask assembly for treatment of sleep disordered breathing by delivering a flow of pressurized gas to a patient including a cushion forming a seal around a patient’s mouth and nose, a frame molded to the cushion and a skeleton frame removably attached to the frame.
  • U.S. Patent No. 8950404, titled Headgear for Masks. It claims a headgear system for holding a respiratory mask in a position on a face of a patient to enhance a mask seal with the patient’s face. The innovative configuration increases the ease of use and lessens the tendency of producing facial marks after wear.
  • headgearU.S. Patent No. 9027556, issued under the title Mask System. It protects a mask system for delivery of a supply of gas at positive pressure to a patient for medical treatment. This invention is intended to enhance the efficacy of treatment for sleep disordered breathing and the modular design allows for a customizable mask.
  • U.S. Patent No. 9381316, entitled Interchangeable Mask Assembly. It discloses an interchangeable mask system for delivering breathable gas to a patient and having multiple cushion components interchangeably interfacing with a common frame to optimize both fit and comfort.

The lawsuit filed by ResMed notes multiple aspects of Fisher & Paykel’s sleep apnea treatment devices which infringe upon its patents-in-suit. The RollFit seal frame utilized by the Simplus face mask, for example, infringes the ‘061 patent by providing a seal for the delivery of a flow of pressurized gas to a mask wearer using a cushion which is more flexible than the mask’s frame. ErgoForm headgear technology marketed by Fisher & Paykel infringes on the ‘404 patent by providing a plurality of straps which enhance a mask’s seal when worn on the face.

Interestingly, two days after ResMed filed its infringement suit, it filed a notice of voluntary dismissal without prejudice, effectively ending its suit. ResMed’s counsel noted that it will argue infringement through counterclaims to a lawsuit filed by Fisher & Paykel in S.D. Cal. on the same day as ResMed’s infringement suit. This decision was made to “simplify the procedural structure,” the motion reads.

There are nine patents-in-suit in Fisher & Paykel’s infringement action. They include:

  • breathing assistanceU.S. Patent No. 8443807, which is titled Breathing Assistance Apparatus. It protects a patient interface having a mask body with two nasal pillows to form a seal against a nare, or nostril, as well as a headgear assembly with two side straps, a top strap and a back strap.
  • U.S. Patent No. 8479741, same title as above. It also claims a patient interface with a mask body made of a substantially flexible plastics material and having nasal pillows which are cylindrical and angled toward each other.
  • U.S. Patent No. 8186345, titled Apparatus for Supplying Gases to a Patient. The apparatus this claims includes a gases supply, a delivery conduit with a heater wire and a controller which applies power to the heater wire. It provides higher reliability for temperature control of gases delivered to a patient with sleep apnea.
  • supplying gasesU.S. Patent No. 8453641, entitled Apparatus for Measuring Properties of Gases Supplied to a Patient. The apparatus claimed here has an electrical circuit in communication with a delivery conduit which provides feedback to a controller when properties of gases vary.
  • U.S. Patent No. 8550072, which is titled Apparatus for Delivering Humidified Gases. It claims an apparatus having a heater base, a pressurized gases outlet in fluid connection with an inlet of a water chamber, a humidified gases return and a blower for generating a supply of pressurized gases.

Fisher & Paykel’s suit targets continuous positive airway pressure (CPAP) technology market by ResMed as the AirSense 10 series. For example, Fisher & Paykel argues that ResMed’s ClimateLine Air technology infringes upon the ‘345 patent as it is an apparatus supplying gases to a patient. Fisher & Paykel also believes that technology used by AirSense 10 devices infringes upon the ‘641 patent because it measures properties of gas for patient delivery, such as humidity and temperature. ResMed’s AirCurve 10 sleep disordered breathing treatment apparatus is also targeted in the suit.

A close examination of ResMed’s suit which was voluntarily dismissed gives a decent idea of how the company will look to challenge Fisher & Paykel’s own infringement charges. ResMed filed claims for relief seeking declaratory judgements of non-infringement and invalidity for each of the nine patents upon which Fisher & Paykel are trying to enforce their rights. ResMed argues that the ‘741 patent is invalid as obvious in light of multiple U.S patent applications as well as one issued patent, U.S. Patent No. 4919128, titled Nasal Adaptor Device and Seal and issued in April 1990 to University Technologies International of Alberta, CA. ResMed argues that the ‘345 patent is rendered obvious by Fisher & Paykel’s MR810 Respiratory Humidifier Technical Manual as well as multiple patents, including U.S. Patent No. 6953354, titled Connector for Breathing Conduits and issued to Fisher & Paykel in October 2005.


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