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Respironics, Inc. v. Invacare Corp.

August 30, 2006

RESPIRONICS, INC. AND RIC INVESTMENTS, INC., PLAINTIFF,
v.
INVACARE CORP., DEFENDANT.



The opinion of the court was delivered by: Gary L. Lancaster, District Judge

MEMORANDUM and ORDER

This is an action in patent infringement. Plaintiffs, Respironics, Inc. and RIC Investments, Inc. ("Respironics") allege that defendant Invacare Corporation ("Invacare") has infringed several of its patents by making, using, selling, or offering to sell the Polaris EX CPAP with SoftX device. Defendant's SoftX device, and plaintiffs' C-Flex device are both used in the treatment of sleep apnea. Defendant contends that its SoftX product does not infringe plaintiffs' patents, and/or that the patents are invalid. The court is prepared to set forth its claim construction rulings pursuant to Markman v. Westview Instruments, Inc., 52 F.3d 967 (Fed. Cir. 1995) (en banc), aff'd, 517 U.S. 370 (1996).

I. FACTUAL BACKGROUND

A. Dispute between the Parties Plaintiffs specialize in the development, manufacture and marketing of sleep therapy devices for the treatment of obstructive sleep apnea ("OSA"). OSA is a condition that causes a patient's airway to collapse during sleep, interrupting the normal flow of breath and waking the patient throughout the night. There are various types of treatment devices for OSA, including CPAP, bi-level, and exhalation unloading. CPAP, or Continuous Positive Airway Pressure, therapy involves blowing a steady stream of air through a nasal mask into the patient's airway while he sleeps in order to keep the airway open. Bi-level positive airway pressure treatment therapy involves blowing a lower pressure of air into the patient's mask during exhalation in order to relieve the discomfort of having to breathe out against a steady stream of air. Finally, exhalation unloading therapy reduces the pressure each time the patient begins exhaling even more than with bi-level therapy, resulting in even greater comfort for the user.

Plaintiffs own numerous patents in this field of sleep therapy devices. Two sets of patents are at issue in this case: the Early Patents and the Later Patents. Put in simple terms, the Early Patents cover bi-level treatment devices and the Later Patents cover exhalation unloading treatment devices.

1. The Early Patents - the '802 and '193 Patents Plaintiffs assert that defendant has infringed and continues to infringe claims 3 and 24 of United States Patent No. 5,148,802 ("the '802 Patent") and claims 9, 44, and 53 of United States Patent No. 5,433,193 ("the '193 Patent"). These patents cover bi-level treatments. They allow a computer to determine, by measuring and comparing flow rates, even in the presence of leakage, when a patient is exhaling so that the device can switch to a lower pressure magnitude during exhalation in order to increase patient comfort. Respironics, Inc. v. AirSep Corp., No. 96-cv-2129, Opinion at 12-13 (W.D. Pa. Nov. 10, 1997).

2. The Later Patents - the '575 and '517 Patents Plaintiffs assert that defendant has infringed and continues to infringe claims 21, 23, 43, and 44 of United States Patent No. 6,105,575 ("the '575 Patent"). Plaintiffs also assert that defendant infringed claims 29, 30, and 32 of United States Patent No. 6,609,517 ("the '517 Patent") at the MedTrade '03 trade show. These patents cover exhalation unloading treatments. They allow the exhalation pressure to be decreased at the beginning of exhalation, even below the decrease found in bi-level therapy.

The patents teach two methods for causing this pressure decrease:

(1) in conjunction with the depth of a patient's breathing (i.e., proportional); or (2) independently of a patient's breathing (i.e., predetermined).

B. Contested Claims with Disputed Terms or Phrases Highlighted

1. The Early Patents - the '802 and '193 Patents

The claims of the Early Patents that plaintiffs allege defendant's device has infringed are reproduced in full immediately below, with the terms and/or phrases that are in dispute, and allegedly in need of construction by this court, indicated in bold and underlined text. Although these claims are lengthy, the disputed terms are repeated throughout the claims, and need only be construed once.

In short, the court must construe the following terms or phrases of The Early Patents: (1) "selected higher and lower pressure magnitudes"; (2) "flow rate"; (3) "continually detecting the instantaneous flow rate"; (4) "utilizing [and utilizing at least one of] said instantaneous flow rate and said reference indicia to select one of said higher and said lower pressure magnitudes for said flow of breathing gas to be applied in the airway of such a patient."

(a) The '802 Patent, Claim 3

A method of medical treatment for a patient comprising the steps of: providing a flow of breathing gas from a source for delivery to the airway of such a patient at selected higher and lower pressure magnitudes at least as great as ambient atmospheric pressure; continually detecting the instantaneous flow rate of said breathing gas flowing between said source and the airway of such a patient; continually processing selected parameters including said instantaneous flow rate to provide a reference indicia corresponding to an average flow rate of breathing gas flowing between said source and said patient; and utilizing said instantaneous flow rate and said reference indicia to select one of said higher and said lower pressure magnitudes for said flow of breathing gas to be applied in the airway of such a patient.

(b) The '802 Patent, Claim 24

A method of treating sleep apnea comprising the steps of: providing a flow of breathing gas from a source for delivery to the airway of a patient at selected higher and lower pressure magnitudes at least as great as ambient atmospheric pressure; continually detecting the instantaneous flow rate of said breathing gas flowing between said source and the airway of a patient; continually processing selected parameters including said instantaneous flow rate to provide a reference indicia corresponding to an average flow rate of breathing gas flowing between said source and said patient; and utilizing said instantaneous flow rate and said reference indicia to select one of said higher and said lower pressure magnitudes for said flow of breathing gas.

(c) The '193 Patent, Claim 9

A method of medical treatment for a patient comprising the steps of: providing a flow of breathing gas from a source for delivery to the airway of such a patient at selected higher and lower pressure magnitudes at least as great as ambient atmospheric pressure and permitting said flow of gas to pass from the patient; monitoring said flow to detect an instantaneous flow rate of such breathing gas; processing selected parameters including said instantaneous flow rate to provide a reference indicia corresponding to an average flow rate of such breathing gas; and utilizing at least one of said instantaneous flow rate and said reference indicia to select one of said higher and said lower pressure magnitudes to be applied in the airway of such a patient.

(d) '193 Patent, Claim 44

A method of treating sleep apnea syndrome comprising the steps of: providing a flow of breathing gas from a source for delivery to the airway of a patient at selected higher and lower pressure magnitudes at least as great as ambient atmospheric pressure; permitting said flow of breathing gas to pass from such a patient; monitoring said flow of breathing gas to detect an instantaneous flow rate of said breathing gas; processing selected parameters including said instantaneous flow rate to provide a reference indicia corresponding to an average flow rate of said breathing gas; and utilizing at least one of said instantaneous flow rate and said reference indicia to select one of said higher and said lower pressure magnitudes for said supply flow of breathing gas.

(e) '193 Patent, Claim 53

A method of treating sleep apnea syndrome comprising the steps of: providing a flow of breathing gas from a source for delivery to the airway of a patient at selected higher and lower pressure magnitudes at least as great as ambient atmospheric pressure; permitting said flow of breathing gas to pass from such a patient; monitoring said flow of breathing gas to detect an instantaneous flow rate of said breathing gas; processing selected parameters including said instantaneous flow rate to provide a reference indicia; and utilizing at least one of said instantaneous flow rate and said reference indicia to select one of said higher and said lower pressure magnitudes for said supply flow of breathing gas.

2. The Later Patents - the '575 and '517 Patents

The claims of the Later Patents that plaintiffs allege defendant's device has infringed are reproduced in full immediately below, with the terms and/or phrases that are in dispute, and allegedly in need of construction by this court, indicated in bold and underlined text. Although these claims are lengthy, several of the disputed terms are repeated throughout the different claims, but need only be construed once. In addition, several of the disputed terms or phrases in these patents will have already been construed by the court in the context of the Early Patents.

In short, the court must construe the following phrases of the Later Patents: (1) "A proportional positive airway pressure apparatus"; (2) "predetermined pressure profile"; (3) "wherein a shape of said predetermined pressure profile is set independent of any monitored respiratory characteristics of such a patient"; (4) "fluid characteristic associated with a flow of gas"; (5) "controlling said supply of gas to such a patient during at least a portion of a breathing cycle based on said fluid characteristic signal and said first gain"; (6) "minimally sufficient pressure"; (7) "prevent airway collapse, wherein said minimally sufficient pressure is a summation of a pressure needed to prevent airway collapse and pressure needed to overcome respiratory effort"; (8) "further comprising a step of setting at least one of a magnitude and a duration of said pressure profile"; and (9) "controlling a pressure of the flow of breathing gas delivered to a patient based on a product of the expiratory gain and the fluid characteristic during at least a portion of an expiratory phase of such a patient's breathing cycle, so that a pressure of the flow of breathing gas delivered to the patient during at least a portion of the expiratory phase varies with fluctuations of the fluid characteristic."

(a) '575 Patent, Claim 21

A proportional positive airway pressure apparatus for delivering pressurized breathing gas to an airway of a patient, said apparatus comprising: a gas flow generator; a patient interface adapted to couple said gas flow generator to an airway of a patient; a sensor adapted to detect at least one physiological condition of such a patient, wherein said physiological condition is suitable for use to differentiate between an expiratory phase and an inspiratory phase of a breathing cycle of such a patient and to output a signal indicative thereof; a pressure controller associated with at least one of said gas flow generator and said patient interface to control a pressure of said breathing gas provided by said gas flow generator; control means for controlling said pressure controller so as to cause said breathing gas to be delivered to such a patient at a first pressure level during at least a portion of said inspiratory phase of said breathing cycle and in accordance with a predetermined pressure profile during said expiratory phase of said breathing cycle, wherein a shape of said predetermined pressure profile is set independent of any monitored respiratory characteristics of such a patient.

(b) '575 Patent, Claim 23

A method of providing pressured breathing gas to an airway of a patient, said method comprising the steps of: supplying gas to an airway of such a patient from a source of gas via a patient interface; determining a fluid characteristic associated with a flow of gas within said patient interface and outputting a fluid characteristic signal indicative thereof; establishing a first gain to be applied to said fluid characteristic signal; and controlling said supply of gas to such a patient during at least a portion of a breathing cycle based on said fluid characteristic signal and said first gain so as to deliver said gas to such a patient at a minimally sufficient pressure to perform at least once of the following functions at any given moment during at least a portion of a breathing cycle:

(1) reduce cardiac preload and afterload, wherein said minimally sufficient pressure needed to reduce cardiac preload and afterload in an absence of respiratory loading and a pressure needed to overcome an impact of respiratory loading on cardiac preload and afterload; and

(2) prevent airway collapse, wherein said minimally sufficient pressure is a summation of a pressure needed to prevent airway collapse and pressure needed to overcome respiratory effort.

(c) '575 Patent, Claim 43

A method of delivering pressurized breathing gas to an airway of a patient, said method comprising the steps of: providing a gas flow generator and a patient interface adapted to couple said gas flow generator to an airway of a patient; detecting at least one physiological condition of such a patient, wherein said physiological condition is suitable for use to differentiate between an expiratory phase and an inspiratory phase of a breathing cycle of such a patient and outputting signals indicative thereof; and controlling said gas flow to such a patient at a first pressure level during at least a portion of said inspiratory phase and in accordance with a predetermined pressure profile during said expiratory phase of said breathing cycle, wherein a shape of said predetermined pressure profile is set independent of any monitored respiratory characteristics of such a patient.

(d) '575 Patent, Claim 44

The method of claim 43, further comprising a step of setting at least one of a magnitude and a duration of said pressure profile.

(e) '517 Patent, Claim 29

A method of delivering pressurized breathing gas to an airway of a patient, comprising: generating a flow of breathing gas; sensing a fluid characteristic associated with the flow of breathing gas and outputting a signal corresponding to the fluid characteristic; selecting an expiratory gain; and controlling a pressure of the flow of breathing gas delivered to a patient based on a product of the expiratory gain and the fluid characteristic during at least a portion of an expiratory phase of such a patient's breathing cycle, so that a pressure of the flow of breathing gas delivered to the patient during at least a portion of the expiratory phase varies with fluctuations of the fluid characteristic.

(f) '517 Patent, Claim 30

The method claim 29, wherein generating the flow of breathing gas includes carrying the flow of breathing gas to an airway of a patient via conduit, and wherein controlling the pressure of the flow of ...


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