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Journal Article Costs Party in Interference

July 12, 2002

Decision icon Decision

Last Month at the Federal Circuit - August 2002

Judges: Dyk (author), Mayer, and Rader

In Manning v. Paradis, No. 01-1431 (Fed. Cir. July 12, 2002), the Federal Circuit affirmed a decision by the Board in an interference between James E. Manning and Norman A. Paradis, entering judgment in favor of Paradis.

The invention at issue is directed to a method of delivering oxygen to a subject’s heart during cardiac arrest. The count of the interference claims: “A method of treating a subject in cardiac arrest comprising: blocking the descending aorta of said subject; and then perfusing the aortic arch of said subject with an oxygen-carrying protective solution in an amount effective to deliver oxygen to the heart of said subject.”

Paradis is the named inventor of U.S. Patent No. 5,334,142 (“the ‘142 patent”), filed on September 9, 1991. Manning holds U.S. application No. 08/452,527, filed on May 30, 1995, and accorded the benefit of U.S. application No. 07/769,132 (“the ‘132 application”), filed on September 30, 1991, and now U.S. Patent No. 5,216,032.

Manning filed an affidavit detailing experiments that he performed using dogs in October 1990. During these experiments, a catheter was inserted into a dog and a balloon on a catheter was inflated to occlude the descending aorta and isolate the aortic arch for perfusion. Approximately 500 mL of Oxypherol® and 2 mg of epinephrine were then infused into the dog’s aortic arch over one minute. Pressure sensors revealed a pressure gradient of 6-64 mm Hg during perfusion.

Manning averred in his affidavit that a pressure gradient of 15 mm Hg during CPR had been shown to be required to provide sufficient blood flow to the heart to allow for successful resuscitation. In addition, Manning asserted that rising pressure observed in the right atrium had confirmed that the oxygenated solution flowed through the heart.

Manning described the results of the experiment in an article submitted on September 6, 1991, to Annals of Emergency Medicine and later published in the September 1992 volume. In the article, Manning stated that he was unsure that perfusion had occurred in an amount effective to deliver a measurable quantity of oxygen to the heart. He also questioned the causes to some of the tested results.

The Board, as Manning contended, construed the count of the interference as only requiring the delivery of oxygen to the heart. Using this interpretation, the Board found that the invention had not been reduced to practice in the October 1990 experiment. The Board found that Manning’s affidavit was contradicted by the statements in the journal article and concluded that Manning had failed to definitively establish substantial myocardial perfusion and delivery of oxygen to the heart.

Alternatively, using an alternative construction that required delivery of an amount of oxygen effective for treatment, the Board found insufficient proof that an effective amount of oxygen was delivered and, therefore, held that the count had not been reduced to practice.

On appeal, since Paradis had conceded that Manning had constructed an embodiment or performed a process that met all the limitations of the interference count, the Court considered whether Manning knew that the invention would work for its intended purpose.

In the Federal Circuit’s view, the Board’s decision could not be sustained if the count was construed as requiring delivery of any amount of oxygen to the heart, since there was considerable evidence that Manning delivered some oxygen to the heart and that he appreciated such. The Court, however, interpreted the count as requiring delivery of oxygen in an amount sufficient to have a therapeutic effect on a subject’s heart during cardiac arrest.

Manning argued that the preamble phrase “treating a subject in cardiac arrest” does not limit the count, and that treatment occurs when any amount of oxygen is delivered, even an infinitesimal amount. The Court, however, concluded that a preamble has the import that the claim as a whole suggests for it. The Court reasoned that the preamble defined the intended purpose of the invention, since the invention would have no purpose unless a therapeutic amount of oxygen was delivered. The Court found that the plain meaning of “treat” requires the invention to be used to achieve a therapeutic effect. In support of this construction, the Court pointed to Manning’s specification, which revealed that one of the invention’s purposes was to sustain cellular survival of heart tissue.

Using its count construction, the Federal Circuit determined that Manning did not appreciate that the invention worked for its intended purpose. First, Manning’s article acknowledged that the observed hemodynamic effects may not have resulted from oxygen. In addition, the article noted that the effects of the epinephrine perfusion may have occurred even if the epinephrine did not enter the heart. The Court was also persuaded by Manning’s admission that the experiments were not undertaken to prove the efficacy of selective aortic-arch perfusion.

Accordingly, the Court found that Manning had failed to appreciate that the invention worked for its intended purpose at the relevant time. The Court, therefore, affirmed the Board’s decision that Manning failed to reduce the invention to practice prior to Paradis’s filing date.