Appeal No. 2002-0091 Page 5
Application No. 08/479,884
does not provide adequate guidance to allow those skilled in the art to use the
invention commensurate in scope with the claims. See id.
The examiner reasoned that “[i]n order for one of ordinary skill in the art to
use the claimed variants, the skilled artisan must know if the variant is going to
bind to the receptor with increased or decreased affinity.” Id., page 4. The
examiner acknowledged that the specification’s working examples showing
increased or decreased binding affinity, see id., but concluded that the exemplified
variants would not be predictive of other hGH variants, because:
(1) substitution of the same amino acid residue (e.g., alanine) into
different positions can have different effects on binding affinity
(Examiner’s Answer, pages 4-5); and
(2) substitution of different amino acids into the same position can have
different effects on binding affinity (id., page 5).
The examiner concluded that the effect of amino acid substitution(s) on hGH
receptor binding is highly unpredictable and therefore “the specification can
provide no guidance regarding which other amino acid substitutions would be likely
to result in a hGH variant with a desired biological activity.” Id., page 6.
Appellants argue that there is a reasonable expectation that hGH variants
having amino acid substitutions at the specified positions will have altered binding
affinities compared to wild-type hGH. Appeal Brief, pages 8-9. Appellants also
argue that the amount of experimentation needed to make and screen other
variants is not undue. See id., pages 6 and 9-11. Appellants conclude that
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