Appeal No. 2006-1036
Application No. 10/191,760
amount of experimentation required is ‘undue.’” In re Vaeck, 947 F.2d 488,
495, 20 USPQ2d 1438, 1444 (Fed. Cir. 1991).
In this case, the examiner has done a thorough and commendable job
of explaining the reasons for believing that practicing the claimed method
would have required undue experimentation. The examiner has also
provided evidence to support that position and clearly explained the
relevance of the evidence to the claimed method. Notwithstanding the
examiner’s diligence, however, we conclude that the rejection is based on an
improperly stringent legal standard and must be reversed.
The examiner’s rejection as it relates to the use of
immunocompromised mice or mice pretreated with clodronate has been
considered, but we do not agree with the examiner’s reasoning that the claim
is only enabled for methods of administration in which the mammal is
immunocompromised, as there is an example in the specification that uses a
model that is not immunocompromised, and that is example 8, which is a
canine study.
As noted by the abstract of Connelly,5 of record, the canine model
closely mimics the human disease, and later states on that same page that
canine hemophilia A “has been thoroughly characterized as a model of
hemophilia A in humans.” In addition, Brown 20046 states that “murine
5 Connelly et al. (Connelly), Complete Short-Term Correction of Canine
Hemophilia A by In Vivo Gene Therapy, 88 Blood 3846, (1996)
6 Brown et al. (Brown 2004), Helper-dependent adenoviral vectors mediate
therapeutic factor VIII expression for several months with minimal
accompanying toxicity in a canine model of severe hemophilia A, 103 Blood
804, 805 col. 1 (2004).
6
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