Appeal No. 2006-1036
Application No. 10/191,760
DISCUSSION
Claims 6, 12, 13, and 17 stand rejected under 35 U.S.C. § 112, first
paragraph, “because the specification, while being enabling for practicing
the claimed method by intravenous or local delivery to the liver of a high-
capacity adenoviral vector (HC-Ad) that expresses Factor VIII (FVIII) to
generic immunodeficient hemophiliac mammals; to generic
immunocompetent hemophiliac mammals pre-treated with clodronate
liposomes to deplete the mammal of macrophages; or specifically to
hemophiliac dogs, does not reasonably provide enablement for other
embodiments embraced by the claims. The specification does not enable
any person skilled in the art to which it pertains, or with which it is most
nearly connected, to use the invention commensurate in scope with these
claims” (Answer 3-4).
The examiner asserts that the issue “is whether the specification
combined with the well-known knowledge of the prior art would have
enabled one to broadly practice the method at the lower doses required by
the claimed invention.” Id. at 4. The examiner states that in the working
examples, only intravenous delivery of HC-Ad was examined, and only the
lowest dose was within the range required by the claims. Id. at 5. However,
according to the examiner, “the important results were that physiologically
or therapeutically relevant levels of serum FVIII were NOT obtained at
doses less than 1010 i.u. per kg of body mass in immunocompetent
hemophiliac mice unless the mice were pretreated with clodronate
liposomes.” Id. at 6.
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