Chemistry: molecular biology and microbiology – Vector – per se
Reexamination Certificate
1994-12-15
2001-11-06
Prouty, Rebecca E. (Department: 1652)
Chemistry: molecular biology and microbiology
Vector, per se
C536S023700, C435S069100, C435S252300, C435S325000, C530S350000
Reexamination Certificate
active
06312944
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates, in general, to pneumococcal fimbrial protein A (PfpA). In particular, the present invention relates to a DNA segment encoding a pneumococcal fimbrial protein A gene (pfpA); polypeptides encoded by the DNA segment; recombinant DNA molecules containing the DNA segment; cells containing the recombinant DNA molecule; a method of producing a pneumococcal fimbrial protein A polypeptide; antibodies specific to pneumococcal fimbrial protein A; and a method of measuring the amount of pneumococcal fimbrial protein A in a sample.
2. Background Information
Disease caused by
Streptococcus pneumoniae
(pneumococcus) is an important cause of morbidity and mortality in the United States and developing countries (Sorensen, J. et al. (1986) Scand. J. Infect. Dis. 18:329-335; Wall, R. A. et al. (1986) The Gambia. Bull. WHO 64-4:553-558; Walsh, J. A., and K. S. Warren (1979) N. Eng. J. Med. 301:967-974; Williams, W. W. et al. (1988) Ann. Intern. Med. 108:616-625; Yolken, R. H. et al. (1984) J. Clin. Microbiol. 20:802-805). Pneumococcal disease is very prevalent among the very young, the elderly, and immunocompromised persons. Despite its prevalence, diagnosis of the disease continues to be a problem.
Several tests have been developed to detect pneumococcus antigens and/or antibodies as a means of diagnosing pneumococcus infections (Coonrod, J. D., and M. W. Rytel (1973) J. Lab Clin. Med. 81:778-786; Holmberg, H. et al. (1985) J. Clin. Microbiol. 22:111-115; Ingram, D. L. et al. (1983) J. Clin. Microbiol. 18:1119-1121; Jalonen, E. et al. (1989) J. Infect. 19:127-134; Kanclerski, K. et al. (1988) J. Clin. Microbiol. 26-1:96-100; Makela, P. H. (1982) Scand. J. Infect. Dis. Suppl. 36:111-113; Perlino, C. A. (1984) J. Infect. Dis. 150:139-144; Sippel, J. E. et al. (1984) J. Clin. Microbiol. 20:884-886; Whitby, M. et al. (1985) J. Clin. Pathol. 38:341-344; Yolken, R. H. et al. (1984) J. Clin. Microbiol. 20:802-805). The sensitivity of existing antigen detection tests utilizing body fluids such as serum and urine, remains very low (Ajello, G. W. et al. (1987) J. Clin. Microbiol. 25:1388-1391; Anhalt, J. P., and P. K. W. Yu (1975) J. Clin. Microbiol. 2:510-515; Bartram, C. E. Jr. et al. (1974) J. Lab. Clin. Med. 83:591-598; congeni, B. L. et al. (1984) Ped. Infect. Dis. 3:417-419; Coonrod, J. D. (1983) Proceedings of the American Journal of Medicine Symposium, Jul. 28, 1983, Am. J. Med. 75:85-92; Coovadia, Y. B. and K. K. Naidu (1985) J. Clin. Pathol. 38:561-564; Dilworth, J. A. (1975) J. Clin. Microbiol. 2:453-455; Doskeland, S. O., and B. P. Berdal (1980) J. Clin. Microbial. 11:380-384; Martin, S. J. et al. (1987) J. Clin. Microbiol. 25:248-250), except for antigen detection in cerebrospinal fluids (Henrichsen, J. et al. (1980) J. Clin. Microbiol. 11:589-592; Ingram, D. L. et al. (1983) J. Clin. Microbiol. 18:1119-1121; Lenthe-Eboa, S. et al. (1987) Eur. J. Clin. Microbiol. 6:28-34; Tilton, R. C. et al. (1984) J. Clin. Microbiol. 20:231-234; Yolken, R. H. et al. (1984) J. Clin. Microbiol. 20:802-805). The measurement of antibody response to pneumolysin by enzyme immunoassay (ELISA) appears to be promising for presumptive etiologic diagnosis (Jalonen, E. et al. (1989) J. Infect. 19:127-134; Kalin, M. et al. (1987) J. Clin. Microbiol. 25:226-229; Kanclerski, K. et al. (1988) J. Clin. Microbiol. 26-1:96-100), but the sensitivity and specificity of the test need improvement.
Although a positive blood culture is diagnostic for pneumococcus disease, most patients with bacterial pneumonia do not have bacteremia (Austrian, R. (1974) Prev. Med. 3:443-445; Austrian, R., and I. Gold (1964) Ann. Intern. Med. 60:759-776; Kalin, M. and A. A. Lindberg (1983) Scand. J. Infect. Dis. 15:247-255). The value of sputum cultures has also been questioned because of contamination of the specimens with pharyngeal flora that can include pneumococci (Barrett-Cooner, E. (1971) Ann. Rev. Resp. Dis. 103:845-848). Thus, clinical laboratories are rarely successful in establishing a firm bacterial etiology for those patients with respiratory infections diagnosed presumptively as pneumococcus pneumonia. Researchers have been in constant search for immunodiagnostic markers or tests to aid in the early diagnosis of pneumococcus infections.
SUMMARY OF THE INVENTION
It is a general object of this invention to provide pneumococcal fimbrial protein A (PfpA) (a 37-kilodalton protein).
It is a specific object of this invention to provide a DNA segment which encodes a pneumococcal fimbrial protein A gene (pfpA).
It is a further object of the invention to provide a polypeptide corresponding to a pneumococcal fimbrial protein A gene (pfpA).
It is another object of the invention to provide a recombinant DNA molecule comprising a vector and a DNA segment encoding a pneumococcal fimbrial protein A gene (pfpA).
It is a further object of the invention to provide a cell that contains the above-described recombinant molecule.
It is another object of the invention to provide a method of producing a polypeptide encoding a pneumococcal fimbrial protein A gene (pfpA).
It is a further object of the invention to provide antibodies having binding affinity to a pneumococcal fimbrial protein A gene (pfpA), or a unique portion thereof.
It is a further object of the invention to provide a method of measuring the amount of pneumococcal fimbrial protein A in a sample.
Further objects and advantages of the present invention will be clear from the description that follows.
In one embodiment, the present invention relates to a DNA segment coding for a polypeptide comprising an amino acid sequence corresponding to a pneumococcal fimbrial protein A gene.
In another embodiment, the present invention relates to a polypeptide free of proteins with which it is naturally associated and comprising an amino acid sequence corresponding to a pneumococcal fimbrial protein A gene.
In a further embodiment, the present invention relates to a recombinant DNA molecule comprising a vector and a DNA segment that codes for a polypeptide comprising an amino acid sequence corresponding to a pneumococcal fimbrial protein A gene.
In yet another embodiment, the present invention relates to a cell that contains the above-described recombinant DNA molecule.
In a further embodiment, the present invention relates to a method of producing a polypeptide comprising an amino acid sequence corresponding to a pneumococcal fimbrial protein A gene.
In yet another embodiment, the present invention relates to an antibody having binding affinity to a polypeptide encoding a pneumococcal fimbrial protein A gene, or a unique portion thereof.
In a further embodiment, the present invention relates to a method of measuring the amount of pneumococcal fimbrial protein A in a sample, comprising contacting the sample with the above-described antibodies and measuring the amount of immunocomplexes formed between the antibodies and any pneumococcal fimbrial protein A in the sample.
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Russell et al., “Monoclonal Antibody Recognizing a Species-Specific Protein formStreptococcus pneumoniae”, Journal of Clinical Microbiology, vol. 28, No. 10, Oct. 1990, pp. 2191-2195.*
Lee et al., “Generation of cDNA Probes Directed by Amino Acid Sequence: Cloning of Urate Oxidase”, Science, vol.239, Mar. 1988, pp. 1288-1291.*
Ganeshkumar et al., “Nucleotide Sequence of a Gene Coding for a Saliva-sinding Protein (SsaB) fromStreptococcus sanguis12 and Possible Role of the Protein in Coaggregation with Actinomyces”,Inspection and Immunity, vol. 59, No. 3, 1093-1099, Mar. 1991.
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Fenno et al. “Nucleotide Sequence Analysis of a Type 1 Fimbrial Gene ofStreptococcus sanguisFW213”Infec. & Immun. 57(
O'Connor Steven P.
Russell Harold
Sampson Jacquelyn
Needle & Rosenberg P.C.
Prouty Rebecca E.
The United States of America as represented by the Department of
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