Ex parte WENDELL LIM, JOHN DUEBER, and BRIAN YEH (BPAI)
Appeal 2008-3676
Application 10/613,380
Technology Center 1600
Decided: March 18, 2009
The claim at issue:
1. An autoregulated fusion protein comprising an output domain and a plurality of input domains, wherein at least one of the input domains is heterologous to the output domain, and the input domains interact with each other to allosterically and external ligand-dependently regulate the output domain.
The Applicants provided one working example and described how one of skill in the art would use their techniques to screen other "output domain" (catalytic domains) and "input domain" (regulatory domains, i.e. SH3 domain) to create the autoregulated fusion protein. The Examiner, which the Board agreed with, found that the specification did not provide a person to "predictably produce" a desired fusion protein and that an "extremely large amount of experimentation would be required." The Board instead characterized the specification as "an interesting avenue of further research." The Board explained:
They, may have even paved the way for further research
(see e.g., App. Br. 6). What they have not done is provide an enabling
description of the claimed invention that would allow a person of ordinary skill
in the art to practice the claimed invention without undue
experimentation. Other than the recommendation that one do the screens and
figure it out for yourself, Appellants have provided no guidance on how to
successfully select the appropriate plurality of input domains that can be
fused, with or without a linker, to an output domain to successfully obtain a
fusion protein with the properties one would desire.
Applicants had submitted a declaration stating that “[t]hose skilled in the art have recognized that the invention is not limited to a single embodiment, but that Applicants’ teachings ‘…pave the way for creating new signal-response elements by protein design[’]” The Board found this unconvincing because "providing an interesting avenue for further research (e.g., paving the way) is not the same as providing a disclosure that enables a person of ordinary skill in the art to practice the claimed invention without undue experimentation."
Case can be found here.
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