Appeal No. 1997-0483
Application No. 07/648,900
substitutions in these positions. However, since the positions which differ
between species are few, it would require undue experimentation to
determine what other substitutions in conserved positions can be made and
the scope of the claims is not commensurate with the enablement ....
[Answer, p. 4, para. 2.]
Here, the specification provides the CB3 amino acid sequences of thrombomodulin from
several species, i.e., rabbit, bovine and human, and describes which residues within CB3
are conserved. The specification explicitly describes CB3 as being a cysteine-rich, EGF
homology domain. Figure 6 illustrates the crosslink structure of EGFs 5 and 6, i.e., CB3.
The basic and novel characteristics of the claimed invention are narrowly circumscribed to
require the polypeptide be capable of binding thrombin so as to inhibit the clotting activity
of thrombin without affecting, i.e., increasing, protein C activation. The specification
provides specific guidance for determining whether a candidate polypeptide possesses
such capability. Simply stating that it is possible to generate an enormous number of
possible variants (answer, para. bridging pp. 12-13) does not establish that the
experimentation is undue or that one of ordinary skill in the art would necessarily attempt
every mathematically possible permutation of the residues shown to vary between rabbit,
human and bovine CB3 without regard for the EGF-like nature of the polypeptide. The
examiner has not explained why one skilled in the art would have had any particular
difficulty in carrying out appellants’ claimed invention without undue experimentation in view
of this disclosure. Therefore, this rejection is reversed. Since the examiner has not
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