lumens 16 and 17 having ports 14 and 65 at the distal end of the
catheter (Fig. 9) (RR 007, 1 12; 012, $ 9; and 016, $ 7).
19. Inventors Eddy and Vergano and noninventor Bell
testified that there was no need for testing in a human of the
three-lumen catheter device, since they believed that the three
lumen catheter device (three-lumen Sphincterotome) could be used
in the same manner as a commercially available two-lumen catheter
device (two-lumen Ultratome) (RR 007, 1 12; 012, $ 9; and 017,
9).
20. Although they believed that testing in a human was not
necessary, Eddy, Vergano, and Bell did -test" the three-lumen
catheter by (1) confirming that the tips of the catheter were
articulated and oriented in the same way as the tips of the two
lumen catheter; and (2) cutting pieces of raw cow liver to
confirm that the cutting wire could cut through tissue in the
same manner as a cutting tool used in the two-lumen catheter (RR
007, $ 12; 012, $ 9; and 017, 1 9).
21. Rowland alternatively argues that if actual use in
humans is required to establish an actual reduction to practice,
then such testing was performed on 8 February 1994 (Paper 96 at
22).
22. Rowland alleges that it sent three-lumen catheter
devices to physicians for their evaluation, and that one of these
devices went to Dr. David Carr-Locke at Brigham and Women's
8
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