The Software IP Report

Pump for Monitoring and Controlling Delivery of Fluids to a Patient Held Patent-Eligible

By Mike McCandlish

Categories: Patent Eligibility, Software Patents, The Software IP Report

A complaint alleging infringement of two patents directed to monitoring and controlling an infusion pump has survived a motion to dismiss based on an allegation of unpatentable subject matter under 35 U.S.C. § 101. Baxter International, Inc., v. CareFusion Corp., No. 15-ev-09986 (N.D. Ill. May 13, 2016).  The court found, under the Mayo/Alice test, that the claims are not abstract, but instead are “anchored to a concrete form, and to a particular application,” and therefore are patent eligible.

U.S. Patent No.  5,764,034 is directed to “an infusion pump capable of estimating the amount of time left on a battery by monitoring both the voltage available from the battery and the amount of current flowing from the battery.” A representative claim recites in part

a pump drive mechanism for applying the pumping action to a liquid for infusion in a patient;a battery for

powering the pump drive mechanism;

a circuit which monitors the voltage and current from the battery;

* * *

a circuit responsive to the monitoring circuit which determines the remaining time of charge in the battery; [and]

a battery alarm which occurs when the remaining time of charge in the battery is below a predetermined level.

Defendant CareFusion argued that the ‘034 Patent is directed to the unpatentable abstract idea of calculating the remaining charge on a battery based on well-known voltage and current measurements. According to CareFusion, the claims simply performed these mathematical calculations on a computer.

The court rejected CareFusion’s argument, noting that CareFusion “fails to specify, however, how the human mind would alternately detect voltage output and current flow from a battery to perform the requisite calculation.” Agreeing with plaintiff Baxter, the court noted that the contested claims are not directed to a single element, but include “tangible components within the improved infusion pump.”  These “tangible components,” include “a medical infusion pump, a battery, a battery alarm, a display, and electrical circuits,” and “elevate the ‘034 Patent claims beyond the naked abstract ideas rejected by the courts.”

U.S. Patent No. 6,231,560 (erroneously identified in the opinion as US 6,321,560) is directed to “a method and apparatus for automatically adjusting the medication level for a patient . . . based on the patient’s pain intensity.” A representative claim recites in part

programming the infusion pump with a medication algorithm;

initiating an evaluation of the patient’s medication;

obtaining information pertaining to the patient’s condition;

obtaining information pertaining to the patient’s current medication; and

controlling administration of the patient’s medication based on the evaluation.

Regarding the ‘560 Patent, CareFusion argued that it is directed to the  unpatentable abstract idea of calculating a patient’s medication dose, simply replacing the mental process engaged in by a physician with an algorithm on a processor.

The court again rejected CareFusion’s argument and found that, rather than being directed to an abstract idea, the claims “incorporate physical and tangible components directed towards . . . an improved infusion pump system capable of automatic, dynamic adjustment of a patient’s medicine . . .” The tangible components included a liquid injection device, a conduit, a pumping mechanism, etc.  The hardware a methods function together to respond to a specific patient’s condition and to adjust the medication dosage, all in real time. This improvement in infusion pump technology, the court said, weighs toward a finding of patentability.

This is yet another case illustrating the inconsistent seas of Alice and Section 101 patent-eligibility law.  Certainly the court here could have concluded that the recited hardware was generic, and that there was no technological improvement, e.g., increased efficiency to the generic hardware, in these claims.  But, in this court, at least, this patent owner can carry the fight to another day.