Appeal No. 2007-1080
Application No. 10/790,658
addressed during prosecution, which raises questions about the adequacy of
the enablement of the claimed invention provided in the application’s
written description. Accordingly, we vacate the rejection and remand the
application to the Examiner to further consider this evidence. In vacating
this rejection, we note that the Examiner’s reasons of record for finding lack
of enablement were not sufficiently developed for us to decide the rejection
on its merits.
Billiau generally establishes that gamma-interferon is known to play
an important regulatory role in the immune response. To study its biological
effects, gamma-interferon has been administered in various in vitro and in
vivo settings (e.g., Billiau at 76-81). Increased levels of gamma-interferon in
these studies did not appear to always augment the immune system response.
For example, Billiau reports that gamma-interferon stimulated rather than
inhibited HIV viral replication (Billiau at 96). This seems to suggest that
increasing gamma-interferon levels to treat AIDS as recited in claims in
claims 37 and 60 would enhance the disease, rather than ameliorate it.
In addition, Billiau describe studies in which gamma-interferon
enhanced tumor growth (Id.). Treatment of cancer is recited in claims 38
and 61.
Although the claims require the immune dysfunction to be associated
with reduced gamma-interferon levels, it is not clear from the record
whether the discordant results reported by Billiau are a consequence of not
being associated with a gamma-interferon defect, or as being an artifact of
the experimental system (e.g., cellular versus whole animal with intact
immune system). Because these issues were not fully addressed on the
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