Appeal No. 95-0371
Application 07/965,304
humans which are not suffering from an autoimmune disease. Rather, claims 4 and 10 are
directed to administering fludarabine to humans in general in order to prevent or
prophylactically treat an autoimmune disease. Depending upon whether the amount of
fludarabine administered to the humans in Boldt would be considered an effective amount
for the purposes of this invention, Boldt may anticipate claims such as claims 4 and 10.
See In re Woodruff, 919 F.2d 1575, 1578, 16 USPQ 1934, 1936 (Fed. Cir. 1990) (“It is a
general rule that merely discovering and claiming a new benefit of an old process cannot
render the process again patentable.”)
Upon return of the application, the examiner should determine whether the amounts
of fludarabine administered in Boldt fall within the metes and bounds of the
“effective amount” required by claims such as claims 4 and 10. If so, the examiner should
then determine whether or not Boldt constitutes an anticipation of these claims.
Carrera is relevant for its discussion of the use of 2-chloro-deoxyadenosine in the
treatment of rheumatoid arthritis (an autoimmune disease). Of most significance, is the
disclosure in the last full paragraph of the left hand column of page 1486 of Carrera which
appears to indicate that fludarabine may function in a similar manner to the active agent
under investigation.
Upon return of the application, the examiner should consider the full text of Carrera
and determine whether or not it suggests that fludarabine would be useful in treating
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