Appeal No. 2002-1740
Application No. 08/447,398
Brief and Reply Brief for the appellant's arguments thereagainst. As a consequence of
our review, we make the determinations which follow.
Background
According to the specification, the invention relates to immunotherapeutic agents
and vaccines against pathogenic organisms such as bacteria, protozoa, viruses and
fungus. Specification, page 1. The specification, page 2, states that “M. tuberculosis
is particularly well suited for demonstrating the principles and advantages of the present
invention.”
“[In] an exemplary embodiment of the present invention, the target pathogen is
M. tuberculosis and the majorly abundant products released extracellularly by M.
tuberculosis into broth culture are separated from other bacterial components and used
to elicit an immune response in mammalian hosts. Individual proteins or groups of
proteins are then utilized in animal based challenge experiments to identify those which
induce protective immunity making them suitable for use as vaccines.” Specification,
page 18.
“More specifically, following the growth and harvesting of the bacteria, by virtue
of their physical abundance the principal extracellular products are separated from
intrabacterial and other components through centrifugation and filtration. If desired, the
resultant bulk filtrate is then subjected to fractionation using ammonium sulfate
precipitation with subsequent dialysis to give a mixture of extracellular products,
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