Appeal No. 2006-2451 Page 3
Application No. 09/988,150
Obviousness
Claims 11-13 and 15-19 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Smith2 in view of Bomberger and Almeida.3
Smith provides a composition for oral administration of proteins. Smith, page 1,
lines 3-6. The composition comprises a protein, an antibody which specifically binds to
the protein, and polymer beads. Id., page 4, lines 11-16. The composition is targeted
to M cells, a type of cell which occurs “in the epithelial lining of the Peyer’s patch
lymphoid follicles of the intestine.” Id., page 2, lines 19-20. “M cells are able to
endocytose small amounts of particulate matter from the gut lumen for presentation to
the gut associated lymphoid tissue (GALT).” Id., page 2, lines 27-30. “The theory
behind the use of such a composition is that an antibody raised against a biologically
active peptide or protein will not only bind specifically to that peptide or protein but will
also bind non-specifically to the M cell surface so allowing a bead or particle carrying
the peptide or protein and the antibody to be carried into and across M cells.” Id.,
page 4, lines 18-24. Examples of proteins that can be orally administered include
hormones, interferons, blood factors, and antigenic proteins for eliciting an immune
response. Id., page 6, line 5-31. “The biologically active material [protein] will generally
be adsorbed onto the surface of the beads and the antibody is added so as to form a
complex between the material and the antibody and to leave part of the antibody free for
non-specific binding to the M cells.” Id., page 7, lines 5-9.
2 Smith et al. (Smith), WO 94/28879, published Dec. 22, 1994
3 Almeida et al. (Almeida), Journal of Drug Targeting, 3:455-467, 1996
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