Appeal No. 2002-1740
Application No. 08/447,398
Borremans is relied on for the disclosure of the gene and protein sequence of a
32kD antigen from Mycobacterium tuberculosis. Borremans found the 32 kD
extracellular protein to be a major stimulant of cellular and humoral immunity against
mycobacterium (abstract). Answer, page 7.
Salata teaches a purified Mycobacterium 30kD extracellular protein. From
guinea pig skin testing Salata concluded that the “30,000 dalton antigen of M.
tuberculosis may possess greater tuberculin sensitivity than PPD-S [tuberculin-purified
protein derivative].” Salata, page 594, column 2. Wallis teaches a purified
Mycobacterium 58kD extracellular protein, Verbon teaches purified Mycobacterium 24,
16 and 12kD extracellular proteins, Zhang teaches a purified Mycobacterium 23kD
extracellular protein, and Munk teaches purified Mycobacterium 71 and 12 kD
extracellular proteins. Answer, pages 7-8.
The examiner summarizes (Answer, page 8):
It would have been obvious at the time the invention was made to a
person having ordinary skill in the art to follow the teachings and
suggestions of Pal et al concerning subunit vaccines by using individual,
purified extracellular proteins of the other cited references in order to
reduce any unwanted side effects caused by inclusion of components
which may result in unwanted and/or unnecessary immune responses
while providing an agent for vaccination.
Upon review of the evidence of record, we agree that the examiner
has provided sufficient evidence to support a prima facie case of obviousness. In
particular, Pal discloses a “purified”, e.g., isolated EP extracellular protein fraction from
Mycobacterium tuberculosis. The EP extracellular protein fraction was filtered,
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