of the subject matter of the count is to insert the catheter into
a body passage for performing some operation in the body passage.
Rowland did not test the three-lumen catheter to ensure that it
could be inserted into a body passage, or to ensure that tissue
can be cut and contrast fluid can be injected in the body
passage.
Rowland argues that testing in humans was not necessary,
since inventors Eddy and Vergano and noninventor Bell believed
that the three-lumen catheter device would be used, and would
work in the same manner as the two-lumen catheter device (Finding
19). Instead the inventors, along with Ms. Bell, performed a
bench test to confirm that the tips of the three-lumen catheter
were oriented in the same fashion as in the two-lumen catheter,
and that the cutting tool would work the same as a cutting tool
in a two-lumen catheter (Finding 20).
The problem with Rowland's argument is that Rowland simply
asks us to take the inventors' and Ms. Bell's word that the
three-lumen catheter device was so similar to the two-lumen
catheter device that testing in humans was not necessary.
Rowland fails to direct us to evidence to support the assertion.
Obviously, the two devices are not the same. Yet, Rowland
provides no adequate explanation as to why testing of the three
lumen catheter in a body passage was not necessary despite the
three-lumen catheter's being a different device from the two
13
Page: Previous 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Next
Last modified: November 3, 2007