Appeal No. 1997-1705
Application 08/211,352
1191), which includes the statement cited above regarding the
effect of botulinum toxin on spasticity in children with
cerebral palsy being studied, Jankovic states that “[f]urther
studies are needed to establish the efficacy and safety of
botulinum toxin in these and other disorders associated with
muscular spasms”. However, in this section Jankovic also
states that “[t]here are no absolute contraindications to
injections of botulinum toxin except a history of
hypersensitivity to the toxin (none yet reported) and
infection at the site of injection. Thus far, no
teratogenicity has been attributed to botulinum toxin, even
though several women have been injected during pregnancy.
Because botulinum toxin acts on the final common pathway,
spasms of any cause could be temporarily relieved by this
treatment.” This teaching would have provided one of ordinary
skill in the art with a reasonable expectation that
administering botulinum toxin A to a child less than seven
years old would not be accompanied by any side effects which
would render such treatment inadvisable. Consequently, we
conclude that such an administration of botulinum toxin A
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