Appeal No. 1997-3275
Application No. 07/963,329
Background
Applicants describe the claimed invention at page 5 of the Specification as being
directed to a method of enhancing the survival of mammalian retinal neuronal cells at risk
of dying, by administering to the mammal an effective dose of at least one insulin-like
1
growth factor (IGF) and particularly type 1 insulin-like growth factor (IGF-1) . Claim 1, on
appeal, is directed to enhancing the survival of photoreceptors in danger of dying.
The rejection under 35 U.S.C. § 112, first paragraph
The examiner has rejected claim 1 under 35 U.S.C. § 112, first paragraph as being
based on a disclosure which is not enabling in that it fails to teach how to use the claimed
invention. In so doing, the examiner has withdrawn that portion of her arguments in support
of this rejection to the extent that they rely on the lack of predictability of IGF-I being able to
cross the Brain Blood Barrier (BBB). (Supp. Examiner's Answer, page 1).
The examiner, initially, argues that the specification lacks adequate guidance for
the dose of IGF-1 to be used in the claimed method because a dose appropriate for
intraorbital administration might not be effective for subcutaneous administration.
(Answer, page 5). The examiner, further, urges that the specification lacks adequate
guidance for the use of IGF-1 in promoting survival of mammalian photoreceptor cells. The
examiner appears to take the position that since the examples of the specification are in
1The type 1 insulin-like growth factor is referenced in this record and the references
relied on by the examiner as alternatively IGF-1 and IGF-I. For purposes of this appeal, we
note that which ever designation is used, the underlying material is the same.
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