Appeal No. 1999-1427
Application No. 08/372,429
anti HIVenv systemic response to mucosal genetic immunization.” Page 34.
One of the immunized mice was assayed for secretory IgA response and the
specification discloses that both bronchial epithelium and colonic mucosa
showed labeling of IgA on mucosal surfaces. Id. The specification concludes
that the “visualization of IgA responses following genetic mucosal immunization
and the binding of HIV envelope proteins from H9/IIB infected cells represents a
specific secretory IgA response to mucosal genetic immunization.” Id.
Discussion
The examiner rejected the claimed method as nonenabled, on the basis
that the specification does not enable those skilled in the art “to afford the
mammal a long-term protective immune response to a pathogen.” Examiner’s
Answer, page 4. The examiner notes that the specification does not include
working examples showing that the claimed method provides protective immunity
to infection. The examiner also cites prior art which she characterizes as casting
doubt on whether mucosal immunity would provide protection from infection,
even if the transfected DNA was expressed properly. Id., page 7.
The examiner acknowledges the working example in the specification but
concludes that is does not provide the required guidance because “[n]o challenge
was performed to test protectivity,” and “[m]ice are not receptive to infection with
HIV and are not an art accepted model for HIV infection.” Id., page 10. In
addition, the examiner notes that only a single mouse was assayed for secretory
IgA response and concludes that “[o]ne cannot extrapolate the results of one
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