Appeal No. 1997-1849
Application 08/414,180
Fourth, it is incumbent on the PTO, whenever a rejection based on the enablement
requirement of 35 U.S.C. § 112, first paragraph, is made, to explain why it doubts the truth
or accuracy of any statement in a supporting disclosure and to back up assertions of its
own with acceptable evidence or reasoning inconsistent with the contested statement.
This the examiner has not done. For reasons already discussed, we believe that the
evidence of record is consistent with statements in applicants' specification respecting
how to use 1-substituted-phenyl-3-azabicyclo[3.1.0]hexanes for treating a human or animal
suffering from chemical dependence on alcohol or cocaine.
Fifth, the Epstein Declaration, attached to applicants' Appeal Brief, establishes with
the locomotor activity test that 1-(4-methylphenyl)-3-azabicyclo[3.1.0]hexane hydrochloride
shows full antagonism of the stimulant effects of cocaine at 20-25 mg/kg, and has an AD50
of 7.65 mg/kg. The compound 1-(3,4-dichlorophenyl)-3-azabicyclo-[3.1.0]hexane
hydrochloride shows similar effects, although it is not as potent. Both sets of data
constitute evidence of the effective treatment of cocaine abuse, and how to use
representative 1-(substituted-phenyl)-3-azabicyclo[3.1.0]hexanes, consistent with the
disclosure set forth in applicants' specification.
Sixth, in the specification, pages 26-28, applicants describe how to use their
1-(substituted-phenyl)-3-azabicyclo[3.1.0]-hexanes, including specific modes of
administration, dosages, and preparation of dosage forms. All in all, we have no doubt
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