Appeal No. 2002-1740
Application No. 08/447,398
Claim 47 is illustrative of the claims on appeal and reads as follows:
47. A vaccinating agent for use in immunizing a mammalian host susceptible to
disease caused by a pathogen from the genus Mycobacterium, comprising a
recombinant purified Mycobacterium 32 kD extracellular protein, and an adjuvant, with
the proviso that said vaccinating agent does not contain an immunologically protective
amount of unpurified Mycobacterium extracellular protein.
The prior art references relied upon by the examiner are:
Borremans, M., et al., “Cloning, Sequence Determination, and Expression of a 32 -
Kilodalton-Protein Gene of Mycobacterium tuberculosis,” Infection and Immunity, Vol.
57, No. 10, pp. 3123-3130 (1989)
Pal, P.G., et al., “Immunization with Extracellular Proteins of Mycobacterium
tuberculosis Induces Cell-Mediated Immune Responses and Substantial Protective
Immunity in a Guinea Pig Model of Pulmonary Tuberculosis,” Infection and Immunity,
Vol. 60, No. 11, pp 4781-4792 (1992)
Salata, R.A., et al., “Purification and Characterization of the 30,000 dalton Native
Antigen of Mycobacterium tuberculosis and Characterization of Six Monoclonal
Antibodies Reactive with a Major Epitope of This Antigen,” Journal of Laboratory and
Clinical Medicine, Vol. 118, pp. 589-598 (1991)
Wallis, R.S., et al., “Identification by Two-Dimensional Gel Electrophoresis of a 58
Kilodalton Tumor Necrosis Factor-Inducing Protein of Mycobacterium tuberculosis,”
Infection and Immunity, Vol. 61, No. 2, pp. 627-632 (1993)
Zhang, Y., et al., “Genetic Analysis of Superoxide Dismutase, the 23 Kilodalton Antigen
of Mycobacterium tuberculosis,” Molecular Microbiology, Vol. 5, No. 2, pp. 381-391
(1991)
Munk, M.E., et al., “T Cell Responses of Normal Individuals Towards Recombinant
Protein Antigens of Mycobacterium tuberculosis,” European Journal of Immunology,
Vol. 18, pp. 1835-1838 (1988)
Verbon, A., et al., “Ontwikkeling van een seriolgiche test voor tuberculose,” Nederlands
Tudscrift voor Geneeskunde, Vol. 135, No. 4, pp. 134-138 (1991)
Wiegeshaus, E., et al., “Evaluation of Protective Potency of New Tuberculosis
Vaccines,” Reviews of Infectious Diseases, Vol. 11, Suppl. 2, pp. S484-S490 (1989)
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