Appeal No. 1999-1427
Application No. 08/372,429
The examiner relies on the following references:
Makela et al., “Animal Models for Vaccines to Prevent Infectious
Diseases,” Vaccine, Vol. 14, pp. 717-731
Marshall, “Gene Therapy’s Growing Pains,” Science, Vol. 269, pp. 1050-
1055 (1995)
Orkin et al., Report and Recommendations of the Panel to Assess the NIH
Investment in Research on Gene Therapy, National Institutes of Health (1995)
Holmgren et al., “Mucosal Immunity: Implications for Vaccine
Development,” Immunobiology, Vol. 184, pp. 157-179 (1992)
Claims 1-7 stand rejected under 35 U.S.C. § 112, first paragraph, as
unsupported by an enabling disclosure.
We reverse.
Background
“Mucosal surfaces represent the major route of entry for most systemic
pathogens with subsequent mucosal immunity usually providing long-term
protection against reinfection.” Specification, page 1. The specification discloses
a “method of inducing a mucosal immune response in a subject, comprising
administering to the mucosa of the subject an amount of antigen-encoding DNA
effective to induce a mucosal immune response complexed to a transfection-
facilitating lipospermine or a lipospermidine.” Id.
The specification includes a working example showing that DNA encoding
the HIV env protein induces a mucosal immune response in mice when
administered, complexed to dioctadecylamidoglycylspermine, via nasal aerosol.
See pages 29-34. The specification states that the experiment produced “a clear
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