Appeal No. 2005-1442 Page 2
Application No. 09/734,786
modification is enhanced by treating the histocultured tissues with collagenase prior to
genetic modification.” Pages 2-3.
The specification states that
[a]lthough it is advantageous to treat the cultured tissue with collagenase
in order to enhance the ability of the tissue to accept heterologous nucleic
acids, the treatment is not so severe as to destroy completely the integrity
of the three-dimensional array.
The three-dimensional histoculture can be assembled from any tissue,
including skin, especially skin containing hair follicles, lymphoid tissue, or
tumor tissue. The choice of tissue will depend on the nature of the
treatment contemplated. . . .
For example, hair follicles are useful recipients of genes intended to affect
the growth or quality of hair, but also are able to produce immunogens and
other products that may be useful to the organism taken as a whole.
Page 4.
The specification provides a working example in which DNA encoding green
fluorescent protein (GFP) was introduced into hair follicles of histocultured mouse skin;
the percentage of GFP-expressing hair follicles ranged from 22% to 67%. See pages
11-12. In a second working example, hair follicles in skin samples were transfected with
GFP-encoding DNA and grafted onto recipient mice. The results showed that “the
percentage of hair follicles with GFP fluorescence in collagenase-treated skin was 5.7
times greater than in hair follicles of untreated skin.” Pages 14-15. Fluorescence was
detected for at least 10 days after grafting. Figure 3B.
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