Appeal No. 1996-1916
Application 07/912,122
sequences” of the 3.4 kb cDNA transcript, and appellant concludes that the 1.9 kb
transcript encodes a secreted, soluble form of Flk-2 (specification, pages 2 and 9).
Soluble Flk-2 lacks 59% of the extracellular domain of the Flk-2 transmembrane receptor,
thus, the examiner considers it to be “extremely unpredictable that an extracellular domain
consisting of only 41% of the previously known receptor would retain ligand binding
function” or “be able to achieve a conformation such as to form structures necessary for
antibody recognition.” Further, the examiner believes “[i]n the absence of any structural or
functional characterization of the encoded protein, it would require undue experimentation
to use the claimed DNA to make protein, make antibodies to that protein, determine the
individual specificities of all such antibodies, and then determine how to use such based
upon those specificities.” Accordingly, claims 1 through 4 and 7 stand rejected under 35
U.S.C. § 112, first paragraph, as the specification “does not enable how to use the
claimed DNA or protein.” Examiner’s Answer, page 4.
It is well settled that the specification need only teach one skilled in the art how to
make and use the claimed invention, and that it is the examiner’s initial burden to provide
reasons why a supporting disclosure does not enable a claim. As stated in
In re Marzocchi, 439 F.2d 220, 223, 169 USPQ 367, 369-70 (CCPA 1971):
[A] specification disclosure which contains a teaching of the manner and
process of making and using the invention in terms which correspond in
scope to those used in describing and defining the subject matter sought to
be patented must be taken as in compliance with the enabling requirement
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