Appeal No. 2006-0735
Reexamination Control No. 90/006,036
(‘038, col. 2, lines 38-48).
9. Regarding the localization signal, the examiner directs us to that portion of the ‘038
specification indicating that the localization signal tethered to the therapeutic agent
may be a “viral packaging signal, or other equivalent element, to place the inhibitory
RNA in the same location as the target RNA.” (Examiner’s Answer (“Answer”) at 5,
directing us to col. 2, lines 21-25 of ‘038).
10. Further regarding the localization signal, the ‘038 specification states that
“[l]ocalization signals include any proteinaceous or nucleic acid component which
naturally becomes localized in the desired compartment, for example, a viral
packaging signal or its equivalent (‘038 at col. 3, lines 8-11) and that “[e]xamples of
useful localization signals and cell compartments include viral genomic packaging
signals, for example, for RNA viral genomes, including, retroviruses
(HIV...)...”(‘038 at col. 3, lines 8-30, emphasis added).
11. Regarding antisense RNA as therapeutic agents, the ‘038 specification states that
methods of the invention work by tethering the antisense RNA “to an appropriate
localization signal to sort them to the therapeutically important intracellular and viral
location where the viral replication machinery is active.” (‘038 at 4:1–3).
12. According to the ‘038 specification, the enhanced therapeutic effect is achieved by
“causing the agent to be located in a small defined compartment within the target
(e.g., within a viral particle), or to be located in the same space within a compartment,
e.g., in a nucleus at the location of synthesis of the target”. (‘038 at col. 3, lines 2-7).
13. The ‘038 specification states that, as an example, “to improve ribozyme and other
RNA-based inhibition of HIV replication, the HIV packaging signal...can be placed
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