Interference No. 104,290
in vitro static sample of explanted tissue, let alone a dynamic
organ. EX-5153, 110. Since the invention has been described as
merely an improvement in a single needle ablation device, it
would seem to be incumbent on the part of the experimenters to
show that multiple electrodes could be accurately and repeatably
deployed at a predesignated location in the target organ.
Furthermore, Hansen states that the ability to deploy the elec
trodes at a designated target is made even more uncertain in that
the tissue in a living patient undergoes movement due to respira
tion, arterial pulsation and peristaltic motion of adjacent
organs. Id. Hence, the simple forcing of the distal end of the
catheter to a random position in the explanted liver, as was
apparently the experimental protocol used here," does not appear
" Apparently, the experiments were undertaken with only a
verbal protocol. LeVeen and Fox agree on this point. LR92;
LR192. Kilzer is of the opinion that some written protocols
existed. LR289-91. Notwithstanding the conclusory sta:tements
of Fox and LeVeen that the experiments were successful, it is
difficult for the junior party to prove the success of any
experiment without evidence of some sort of protocol or criteria
for defining success. Note the following exchange at LR128:
Q Did that [oral] protocol define what was considered a
successful ablation?
A In general--in a general sense, as before, large size and
homogeneity was probably a parenthetical desired outcome, but it
was not a criteria. There were no specific criteria. Criteria
(continued ...
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