Appeal No. 2002-1740
Application No. 08/447,398
The examiner provides evidence (Wiesgeshaus), which according to the
examiner, indicates that at “the time of filing of the instant specification, there remained
a lack of correlation of success in animal models with successful vaccination of humans
against mycobacterial disease....” Answer, page 5. The examiner further argues that
“there would not be a reasonable expectation of success that the guinea pig model for
vaccination would correlate to success in humans, and there would not be an
expectation of success using an extracellular 32 KD protein from one species, e.g. M.
xenopi, to vaccinate successfully against disease caused by M. leprae or M.
tuberculosis.” Id.
We disagree with the examiner, and find that the evidence of record supports the
position that the guinea pig model, while agreeably may not be an exact model of
human Mycobacterium tuberculosis, is well accepted and recognized in the art as an
animal model of Mycobacterium tuberculosis which can be reasonably correlated to the
disease in humans. The specification page 6, suggests that the guinea pig model of
Mycobacterium tuberculosis closely resembles the human pathology of the disease. In
addition, several of the cited references, including Pal, Salata and Wiegeshaus also
recognize the guinea pig model. Appellant, similarly proffers Kubica to establish that
the guinea pig model is a recognized model for Mycobacterium tuberculosis. Brief,
pages 10-11.
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