Appeal No. 2006-0735
Reexamination Control No. 90/006,036
working embodiment involving a proteinaceous signal sequence tethered to a therapeutic
nucleic acid..” (Answer at 8). The examiner determined that “the skilled artisan would
reasonably conclude that applicants were not in possession of the claimed invention at the
time of filing.” (Answer at 8).
The examiner does not dispute that the ‘038 specification discloses nucleic acid
therapeutic agents and protein localizing agents. The examiner, however, argues that the
combination of a nucleic acid therapeutic agent and a protein localizing signal is not
disclosed in such a way that the patentee possessed that combination.
The examiner first argues that “…the disclosure fails to provide any structural or
functional guidance pertaining to suitable chemical linkages that can be employed in the
aforementioned [at claims 5 and 11] invention.”
In reply, the patentee notes that its specification discloses that “localization
signals may be tethered to the therapeutic agent by any desired procedure, for
example....covalent or ionic bond formation between two moieties” (Brief at 20, citing to
‘038 at 3:15-20). Weighing the arguments, we find that the examiner has not explained
to our satisfaction why such a disclosure would not have conveyed to one skilled in the
art that patentees were in possession of the claimed invention. If it is the examiner’s
position that undue experimentation would have been required to determine the
appropriate procedures for tethering the particular localization signals (e.g., a protein), to
a particular therapeutic agent (e.g., a nucleic acid), then perhaps a rejection for failure to
provide an enabling disclosure might have been in order. However, that is not the
rejection before us.
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