Appeal No. 2003-0847 Page 7
Application No. 08/744,685
The rejection also argues that the claims encompass expression in any
mammalian cell, and are not limited to NS/O cells. Moreover, citing Reff and
Delente, the rejection asserts that aberrant glycosylation of recombinant proteins
may be a problem in NS/O cells, and such glycosylation may affect the structure,
stability and solubility of any expressed protein. The rejection concludes:
In view of the insufficient guidance, inadequate examples,
and the lack of predictability of the art as evidenced by Reff [ ],
Paul, Morrison [ ] and Delente [ ] with regard to expressing any
gene coding for a functional protein in any mammalian cell with the
homologous recombination insertional expression vector
encompassed by the scope of the broadly written claims, one
skilled in the art would be forced into undue experimentation in
order to practice the broadly claimed invention.
Id. at 13.
Appellants argue that the Patent Office bears the initial burden of
presenting a prima facie case of unpatentability, and that the examiner has not
met that burden. We agree.
“[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 of the first
paragraph of § 112 unless there is reason to doubt the objective truth of the
statements contained therein which must be relied on for enabling support.” In
re Marzocchi, 439 F.2d 220, 223, 169 USPQ 367, 369 (CCPA 1971) (emphasis
in original). “[It] is incumbent upon the Patent Office, whenever a rejection on
this basis is made, to explain why it doubts the truth or accuracy of any
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