Appeal 2007-0746
Application 10/139,496
ENABLEMENT UNDER § 112, ¶ 1
The Enablement Issue
According to the Examiner:
The monoclonal antibody, KHRI-3 recited in claim 3
is essential to the claimed invention. The reproduction of
monoclonal antibodies is an extremely unpredictable event.
The monoclonal antibody KHRI-3 and hybridoma producing
said monoclonal antibody, disclosed in the specification,
must be obtainable by a repeatable method set forth in the
specification or otherwise be readily available to the public.
The instant specification does not disclose a repeatable
process to obtain the hybridoma producing monoclonal
antibody KHRI-3, and it is not apparent if the hybridoma is
readily available to the public.
(Answer 3-4.)
The Examiner indicated this ground of rejection could be overcome
by making a deposit pursuant to 37 C.F.R. §§ 1.801-.809. The Examiner
emphasized that a deposit made after the filing date would require a
statement that “the deposit is identical to the biological material described in
the specification and in the applicant’s possession at the time the application
was filed.” (Answer 5.) The Examiner’s position is based on Rule 804(b):
When the original deposit is made after the effective filing
date of an application for patent, the applicant must promptly
submit a statement from a person in a position to corroborate
the fact, stating that the biological material which is
deposited is a biological material specifically identified in the
application as filed.
37 C.F.R. § 1.804(b).
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