Appeal No. 1997-2325
Application No. 08/486,403
THE REJECTION UNDER 35 U.S.C. § 112, FIRST PARAGRAPH:
The examiner bears the initial burden of providing reasons why a supporting
disclosure does not enable a claim. In re Marzocchi, 439 F.2d 220, 223, 169
USPQ 367, 369 (CCPA 1971).
The examiner finds (Answer, page 4) that “in order to practice the claimed
invention, the skilled artisan need be reasonably able to predict not only the amino
acid residue sequence of the hormone binding protein … but the skilled artisan
would also need to have reasonable guidance as to what other amino acid
sequences would work.” The examiner points out (Answer, bridging paragraph
pages 4-5) that “SEQ ID NO:3 [of the specification] clearly shows that 48 of the 71
amino acids are unknown [and therefore] … the skilled artisan ... would have to
screen 4820 … different compounds … such efforts would rise to the level of undue
experimentation.”
Appellants argue (Brief, page 11) that:
Appellants have provided in the specification the entire sequence of
an ultraspiracle receptor … [a]dditionally … determining which amino
acid residues, when present in the X positions in SEQ ID NO:3, result
in functional receptors … is largely irrelevant, as it is the identity and
the position of the specified amino acids (i.e., those other than X) that
are required for a protein to be a functional member of the
steroid/thyroid superfamily of receptors [emphasis in original].
In response to appellants’ argument the examiner states (Answer, page 6)
that “[t]he substitution of a single amino acid can have a profound effect on the
charge, affinity, and conformation of the protein; such features go to the heart of the
claimed invention.”
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