Appeal 2007-2864
Application 10/747,798
(Specification 2-3 (references omitted).)
Thus, as set forth in the “Summary of the Invention,” one of the
objects of the invention is to inhibit “the growth of a papillomavirus-
transformed cell in a hyperplastic lesion in a subject by topically
administering to the subject a composition comprising (a) an expression
cassette comprising a promoter, active in the cells of the lesion, operably
linked to a polynucleotide encoding a p53 polypeptide, and (b) a
pharmaceutical preparation suitable for topical delivery, wherein expression
of the p53 polypeptide inhibits growth of the cell.” (Id. at 4)
As set forth by the Specification,
A “papillomavirus-transformed cell” is defined as a cell
wherein there has been transfer of genetic information from the
papillomavirus into the cell. Thus, for instance, a squamous
epithelial cell containing papillomavirus genetic material in the
nucleus is a papillomavirus-transformed cell. The cell can be a
keratinocyte, an epithelial cell, a skin cell, a mucosal cell, or
any other cell that can undergo transformation by a
papillomavirus. The papillomavirus-transformed cell may
express the E6 and E7 HPV products. The hyperplastic lesion
can be a squamous cell hyperplastic lesion, a premalignant
epithelia lesion, a psoriatic lesion, a cutaneous wart, a
periungual wart, an anogenital wart, epidermodysplasi
verruciformis, an intraepithelial neoplastic lesion, a focal
epithelial hyperplasia, a conjunctival papilloma, a conjunctival
carcinoma, a squamous carcinoma, or any pathologic change in
tissue which demonstrates wherein there is an increase in the
number of cells. In a specific embodiment, the papillomavirus
is a human papillomavirus.
(Id. at 4-5.)
4
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