Appeal No. 2006-1036
Application No. 10/191,760
models do not necessarily predict treatment outcomes in higher order
mammals,” and “it is important that HD vectors be tested in a large animal
model before future clinical trials are carried out.” Brown, page 805
The examiner discounted the arguments and evidence presented by
appellants, such as the Chuah declaration, that the hemophiliac dog model is
predictive for treatment parameters of human hemophilia (Answer 12-14).
We find that the statements made by Connelly make clear that at the time of
invention, the canine model was an art accepted model. The examiner
references the statement in Brown 2004 at page 809, column 2, that “[w]e do
not believe that current HD technology is ready for the treatment of human
monogenic disease, especially in light of the relatively small therapeutic
index and the significant interindividual variability of toxicity seen in this
project.” Thus, Appellants have provided evidence that the claimed method
is enabled for treating hemophilia in a mammal as claimed.
Moreover, requiring that a pharmaceutical invention be ready for
clinical testing in humans is not the proper standard. “Usefulness in patent
law, and in particular the context of pharmaceutical inventions, necessarily
includes the expectation of further research and development. The stage at
which an invention in this field becomes useful is well before it is ready to
be administered to humans.” In re Brana, 51 F.3d, 1560, 1568
34 USPQ2d 1436, 1442-43 (Fed. Cir. 1995) (citations omitted). While the
Brana court referred to “usefulness,” the rejection on appeal was for
nonenablement. See id. at 1564, 34 USPQ2d at 1439.
Example 8 of the Specification illustrates that an intravenous injection
corresponding to a dose of 3 x 1011 v.p./kg, which is within the claimed
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