Fleur T. Tehrani, ph.d., P.E. v. Hamilton Medical, Inc., and Hamilton Medical, A.G.

331 F.3d 1355, 67 U.S.P.Q. 2d (BNA) 1015, 2003 U.S. App. LEXIS 11687, 2003 WL 21360705
CourtCourt of Appeals for the Federal Circuit
DecidedJune 13, 2003
Docket02-1177, 02-1178, 02-1227
StatusPublished
Cited by17 cases

This text of 331 F.3d 1355 (Fleur T. Tehrani, ph.d., P.E. v. Hamilton Medical, Inc., and Hamilton Medical, A.G.) is published on Counsel Stack Legal Research, covering Court of Appeals for the Federal Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Fleur T. Tehrani, ph.d., P.E. v. Hamilton Medical, Inc., and Hamilton Medical, A.G., 331 F.3d 1355, 67 U.S.P.Q. 2d (BNA) 1015, 2003 U.S. App. LEXIS 11687, 2003 WL 21360705 (Fed. Cir. 2003).

Opinion

BRYSON, Circuit Judge.

Hamilton Medical, Inc., and Hamilton Medical, A.G., (collectively, “Hamilton”) appeal from a final judgment entered by the United States District Court for the Central District of California in a patent case. The appeal focuses on the district court’s grant of summary judgment of infringement to Dr. Fleur T. Tehrani, the owner of U.S. Patent No. 4,986,268 (“the '268 patent”). We vacate and remand.

I

The '268 patent relates to an apparatus and method for automatically controlling a respirator used for mechanical ventilation of a patient who needs assistance in breathing. The claimed apparatus controls the number of breaths delivered to the patient per minute (breath frequency) and the volume of gas delivered with each breath (tidal volume or ventilation). The apparatus calculates the proper breath frequency and tidal volume based on data representing at least five factors: air vis *1357 cosity in the lungs, lung elastance, barometric pressure, oxygen level of the patient, and carbon dioxide level of the patient.

The two independent claims of the '268 patent provide as follows:

1. In a respirator for varying tidal volume and frequency of breaths of a patient, an apparatus for automatically controlling the respirator comprising:
first means for processing data representing at least air viscosity factor in lungs of the patient, barometric pressure, lung elastance factor of the patient and measured levels of carbon dioxide and oxygen levels of the patient, and for providing, based upon said data, digital output data indicative of required ventilation and optimum frequency for a next breath of the patient;
second means operatively coupled to the first means for converting the digital output data to analog data; and, third means operatively coupled to the second means and to the respirator for converting the analog data to timing and control signals and supplying the timing and control signals to the respirator, the timing and control signals automatically and variably controlling the tidal volume and frequency of inhaled gas provided to the patient by the respirator based upon actual ventilation and breathing frequency requirements of the patient as determined by the first means.
16. In a respirator for varying tidal volume and frequency of breaths of a patient, a method of automatically controlling the respirator comprising the steps of:
(a) measuring levels of carbon dioxide and oxygen of the patient and providing a first pair of data signals indicative of the same;
(b) providing data indicative of at least the patients’ lung elastance factor, air viscosity factor in the lungs and barometric pressure;
(c) determining from said first pair of data signals and from the data provided in step (b) the required ventilation and breathing frequency for a next breath of the patient and providing a second pair of data signals indicative of the same; and,
(d) providing, based upon said second pair of data signals, final data signals for automatically and variably controlling the ventilation and breathing frequency of the respirator based upon actual ventilation and breathing frequency requirements of the patient as determined in step (c).

'268 patent, col. 11, 11. 18-41; col. 12, 11. 45-64.

The written description of the '268 patent describes the preferred embodiment in some detail. Oxygen and carbon dioxide sensors detect the levels of those gases in the patient and send data signals to an analog-to-digital converter. From the converter the data is sent to a digital processor, also known as the controller, which includes a microcomputer that uses an algorithm to determine the values for tidal volume and breath frequency based on the carbon dioxide and oxygen data signals and the data for lung elastance, barometric pressure, and air viscosity. Specifically, the data values for carbon dioxide and oxygen in the patient are used in conjunction with the value for barometric pressure to calculate the partial pressures of carbon dioxide and oxygen. Those partial pressures are then used to calculate the dead space volume, which in turn is used to calculate the target values for tidal volume and breath frequency. The controller produces digital signals for those target values, which are converted to analog signals and then sent to a signal generator and timing control circuit. That circuit then *1358 transmits appropriate signals to control the opening and closing of valves in the respirator.

Dr. Tehrani charged Hamilton with infringing claims 1 and 16 of the '268 patent through the manufacture and sale of its Galileo ventilators. The Galileo ventilator allegedly infringes when operating in Adaptive Support Ventilation (“ASV”) mode, a setting in which the device evaluates the patient’s breathing effort. If there is no detected breathing effort, the device provides full mechanical ventilation, but if there is some patient effort, the device supplements that effort to achieve the target ventilation. The Galileo operator’s manual explains that “[t]he target breathing pattern (tidal volume and rate) is calculated using Otis’ equation, based on the assumption that the optimal breath pattern results in the least work of breathing, and hence also in the least amount of ventilator-applied inspiratory pressure when the patient is passive.” Otis’s equation is an algorithm for calculating the tidal volume and frequency of breaths needed to provide proper gas exchange in humans.
The operator of a Galileo ventilator in ASV mode uses keys and knobs to input the patient’s ideal body weight (based on height), the desired positive end expiratory pressure (“PEEP”), and the desired concentration level of inspired oxygen. The PEEP setting on the Galileo ventilator causes the device to apply a selected positive pressure to the patient’s lungs in order to stabilize the alveoli in the lungs during exhalation and to keep them open during the entire ventilation cycle. The oxygen concentration setting affects only the oxygen concentration in the inspired gas; it does not affect the volume of the gas delivered or the frequency of breaths.
The operator of the Galileo ventilator can also select a setting for percent minute volume (“% MinVol”), which allows the device either to provide full ventila-tory support or, at lesser values, to encourage spontaneous breathing by the patient. When the % MinVol control is set at 100 percent, the ventilator delivers 100 milliliters of air per minute per kilogram of weight to an adult patient. The Galileo device contains no sensor to measure the oxygen or carbon dioxide levels in the patient’s blood or expired gas. Rather, the operator of the device is expected to measure the patient’s levels of oxygen and carbon dioxide manually. If the patient’s blood gas levels are not within the desired ranges, the operator can affect those levels by adjusting one of the input settings described above — either PEEP, oxygen concentration, or % MinVol.

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331 F.3d 1355, 67 U.S.P.Q. 2d (BNA) 1015, 2003 U.S. App. LEXIS 11687, 2003 WL 21360705, Counsel Stack Legal Research, https://law.counselstack.com/opinion/fleur-t-tehrani-phd-pe-v-hamilton-medical-inc-and-hamilton-cafc-2003.