Appeal No. 2001-2316 Page 11
Application No. 08/187,879
the effective filing date of the application shows by factual evidence
that any administration of any SIV or HIV antigen expressing
plasmid vector as disclosed by the as-filed specification by any
delivery route so as to generate a protective response against SIV
and/or HIV can be reasonably reproduced in a representative
number of SIV or HIV infectious mammals including humans.
VI. The predictability or unpredictability of the art/ the quantity of
experimentation necessary:
To demonstrate the unpredictability of the art at the time the invention was
made the examiner relies on Haynes (Answer, bridging paragraph, pages 14-15),
to teach
immune correlates for protection against HIV are not known, that
there is no animal model that mirrors human HIV infection, and that
current animal models for HIV infection do not develop AIDS
symptoms or anti-HIV immune responses analogous to those of
HIV-infected humans, so that it is impossible to determine whether
observation of a given immune response to an immunodeficiency
virus vaccine in an animal model indicates that any HIV antigen
expressing DNA vaccine plasmid vector would actually confer any
protection against HIV infection in any infectious mammal including
humans….
In addition, the examiner notes that similar to the claims on appeal here, the
claims in In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir.
1993), encompassed “vaccines against AIDS viruses and that, because of the
high degree of genetic, antigenic variations in such viruses, no one has yet …
developed a generally successful AIDS virus vaccine.”
In response to the examiner’s findings, appellants rely on Gardner3 and
McClure4, arguing (Reply Brief, page 8), “SIV-infected nonhuman primates are an
excellent animal model system for studies which include studies of vaccines.”
3 Gardner, Dev. Biol. Stand., Vol. 72, pp. 259-66 (1990). We were unable to locate a copy of this
reference in the administrative file.
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