Nature of the Case
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Facts
At issue is D's Patent No. '917, which was accorded the benefit of its May 15, 1980 parent application. P's application '826, was accorded the benefit of its parent application '202, filed May 15, 1981. The invention is a penile implant for men unable to obtain or maintain an erection. It is a self-contained unit that permits the patient to simulate an erection. The implant contains two reservoirs connected through a valve. The invention operates by shifting the inflating liquid between the two reservoirs. When the penis is flaccid, the invention maintains inflating liquid in a reservoir at the base of the penis. A simulated erection occurs when the liquid shifts through the valve into the elongated reservoir implanted in the forward section of the penis. Prior art involved flexible rods and inflatable devices of different types. P and D had contested related subject matter in an earlier interference. The count of 101,149 was a species of the generic count in this interference. P won that earlier interference. Here, D's application has an earlier filing date than P's. P still has an earlier conception date. P did not present evidence of diligence after conception of his invention. P opted to show an actual reduction to practice before Dr. Finney's date of invention. P's primary evidence of actual reduction to practice was a videotape where a surgeon inserted P's prototype device into the penis of an anesthetized patient. The videotape showed the surgeon manipulating the implanted device. Several times the device simulated an erection when the surgeon manipulated the valve. Several times the fluid-filled the forward reservoir. Several times the surgeon returned the penis to a flaccid condition by draining the fluid back into the rear reservoir. After manipulating the implanted device through the skin to simulate having and losing an erection, the surgeon removed the prototype and inserted a prior art external pump mechanism. P presented evidence of testing for leakage, disclosed that the fabrication material was common in implanted devices, and supplied the testimony of Dr. Drogo K. Montague, an expert in the field. Dr. Montague personally handled the device at issue and viewed the videotape. He testified that the video showed, even with only a single tube, sufficient rigidity for intercourse. Both D and Montague agreed that insertion of two tubes would greatly enhance rigidity. The Board held there was insufficient evidence to show reduction to practice. It ruled that P had not shown utility, i.e., that the device would successfully operate under actual use conditions for a reasonable length of time. The Board required 'testing of an implantable medical device under actual use conditions or testing under conditions that closely simulate actual use conditions for an appropriate period of time.' It ruled that P must test his device in actual intercourse or in similar conditions to intercourse for a proper period of time. D got the verdict and P appealed.
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