Appeal No. 2005-2739 Page 3
Application No. 09/966,893
that are present on macrophage membranes but which are not normally present on the
membranes of other cells” Id.
The Claims
Claims 8-13 are the subject of appeal. Claims 1-7 and 14-20 are also pending,
but have been withdrawn from consideration. Claims 8-13 stand rejected under
35 U.S.C. § 112, first paragraph, as lacking enablement and adequate written descriptive
support. In addition, claims 8-13 stand rejected under 35 U.S.C. § 102(a) as anticipated
by Sharp. Claims 8-13 read as follows:
8. A pharmaceutical composition comprising a protein useful for treating a
lysosomal storage disorder other then Fabry disease that is selectively imported into
macrophages when administered to a subject and a pharmaceutically acceptable carrier,
wherein said protein is produced in an insect cell culture.
9. The composition of claim 8 wherein said lysosomal storage disorder is
Galactosialidosis.
10. The composition of claim 8 wherein said protein is protective
protein/cathepsin A (PPCA).
11. The composition of claim 8 wherein said insect cell culture comprises cells
derived from the species selected from the group consisting of Spodoptera frugiperda
and Tricoplusia ni.
12. The composition of claim 11 wherein said cells are Spodoptera frugiperda
Sf9 cells.
13. The composition of claim 8 wherein said protein is produced in the cell culture
using a baculovirus expression system.
Discussion
Written Description
The examiner rejected claims 8-13 under 35 U.S.C. § 112, first paragraph, “as
failing to comply with the written description requirement.” Examiner’s answer, page 3.
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