Appeal No. 2002-1740
Application No. 08/447,398
daltons in the vaccinating agent by using a Millipore filter with a molecular weight cutoff
of 30,000 to concentrate the extracellular products (page 4782, column 2, line 43, and
Figure 2).” Id. The examiner finds, however, that Pal uses isolated but not purified
components. Id.
The examiner indicates Pal establishes that “a subunit vaccine against
tuberculosis is feasible, and that extracellular molecules of M. tuberculosis are potential
candidates for a subunit vaccine.” Answer, page 6. According to Pal, “a subunit
vaccine may induce a higher level of immune protection than whole mycobacterial
vaccine. Second, if a subunit vaccine excludes the structural surface proteins of the
bacterium, the subunit vaccine theoretically should not induce opsonizing antibody,
which may enhance infection by promoting uptake of M. tuberculosis into host cells in
which the bacteria multiply. Third, because it need contain only one or a few molecules
or submolecular fragments, a subunit vaccine is likely to be less toxic than a whole
bacterial vaccine that contains thousands of different molecular species. Finally, in
contrast to a live vaccine, a subunit vaccine would not cause disseminated disease in
immunocompromised persons.” Pal, page 4791, column 1.
As indicated in our claim interpretation set forth above, we do not fully agree with
the examiner’s characterization that Pal uses isolated but not purified components. We
find that isolation or fractionation is a form of purification encompassed by the pending
claims.
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