Chemistry: molecular biology and microbiology – Micro-organism – tissue cell culture or enzyme using process... – Recombinant dna technique included in method of making a...
Reexamination Certificate
2001-01-03
2004-07-20
Smith, Lynette (Department: 1645)
Chemistry: molecular biology and microbiology
Micro-organism, tissue cell culture or enzyme using process...
Recombinant dna technique included in method of making a...
C435S069300, C435S071100, C435S184000, C435S320100, C435S325000, C536S023100, C536S023700, C530S350000, C514S002600, C424S251100, C424S234100, C424S192100, C424S190100
Reexamination Certificate
active
06764834
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to polynucleotides, (herein referred to as “BASB019 polynucleotide(s)”), polypeptides encoded by them (referred to herein as “BASB019” or “BASB019 polypeptide(s)”), recombinant materials and methods for their production. In another aspect, the invention relates to mol for using such polypeptides and polynucleotides, including vaccines against bacterial infections. In a further aspect, the invention relates to diagnostic assays for detecting infection of certain pathogens.
BACKGROUND OF THE INVENTION
Moraxella catarrhalis
(also named
Branhamella catarrhalis
) is a Gram negative bacteria frequently isolated from the human upper respiratory tract. It is responsible for several pathologies the main ones being otitis media in infants and children, and pneumonia in elderlies. It is also responsible of sinusitis, nosocomial infections and less frequently of invasive diseases.
Otitis media is an important childhood disease both by the number of cases and its potential sequelae. More than 3.5 millions cases are recorded every year in the United States, and it is estimated that 80% of the children have experienced at least one episode of otitis before reaching the age of 3 (Klein, J O (1994) Clin.Inf.Dis 19:823). Left untreated, or becoming chronic, this disease may lead to hearing losses that could be temporary (in the case of fluid accumulation in the middle ear) or permanent (if the auditive nerve is damaged). In infants, such hearing losses may be responsible for a delayed speech learning.
Three bacterial species are primarily isolated from the middle ear of children with otitis media:
Streptococcus pneumoniae
, non typeable
Haemophilus influenza
(NTHi) and
M. catarrhalis
. They are present in 60 to 90% of the cases. A review of recent studies shows that
S. pneumoniae
and NTHi represent both about 30%, and
M. catarrhalis
about 15% of the otitis media cases (Murphy, T F (1996) Microbiol.Rev 60:267). Other bacteria could be isolated from the middle ear (
H. influenza
type B,
S. pyogenes
etc) but at a much lower frequency (2% of the cases or less).
Epidemiological data indicate that, for the pathogens found in the middle ear, the colonization of the upper respiratory tract is an absolute prerequisite for the development of an otitis; other are however also required to lead to the disease (Dickinson, D P et al. (1988) J. Infect.Dis. 158:205, Faden, H L et al. (1991) Ann.Otorhinol.Laryngol. 100;612). These are important to trigger the migration of the bacteria into the middle ear via the Eustachian tubes, followed by the initiation of an inflammatory process. These factors are unknown to date. It has been postulated that a transient anomaly of the immune system following a viral infection, for example, could cause an inability to control the colonization of the respiratory tract (Faden, H L et al (1994) J. Infect.Dis. 169:1312). An alternative explanation is that the exposure to environmental factors allow a more important colonization of some children, who subsequently become susceptible to the development of otitis media because of the sustained presence of middle ear pathogens (Murphy, T F(1996) Microbiol.Rev. 60:267).
The immune response to
M. catarrhalis
is poorly characterized. The analysis of strains isolated sequentially from the nasopharynx of babies followed from 0 to 2 years of age, indicates that they get and eliminate frequency new strains. This indicates that an efficacious immune response against this bacteria is mounted by the colonized children (Faden, H L et al (1994) J. Infect.Dis. 169:1312).
In most adults tested, bactericidal antibodies have been identified (Chapman, A J et al. (985) J. Infect.Dis. 151:878). Strains of
M. catarrhalis
present variations in their capacity to resist serum bactericidal activity: in general, isolates from diseased individuals are more resistant than those who are simply colonized (Hol, C et al. (1993) Lancet 341:1281, Jordan, K L et al. (1990) Am.J.Med 88 (suppl. 5A):28S). Serum resistance could therfore be considered as a virulence factor of the bacteria. An opsonizing activity has been observed in the sera of children recovering from otitis media.
The antigens targetted by these different immune responses in humans have not been identified, with the exception of OMP B1, a 84 kDa protein which expression is regulated by iron, and that is recognized by the sera of patients with pneumonia (Sethi, S, et al. (1995) Infect.Immun. 63:1516).
A few other membrane proteins present on the surface of
M catarrhalis
have been characterized using biochemical method, or for their potential implication in the induction of a protective immunity (for review, see Murphy, T F (1996) Microbiol.Rev. 60:267). In a mouse pneumonia model, the presence of antibodies raised against some of them (UspA, CopB) favors a faster clearance of the pulmonary infection. Another polypeptide (OMP CD) is highly conserved among
M. calarrhatis
strains and presents homolgies with a porin of
Pseudomonas aeruginosa
, which has been demonstrated efficacious against this bacteria in animal models.
The frequency of
Moraxella catarrhalis
infections has risen dramatically in the past few decades. This has been attributed to the emergence of multiply antibiotic resistant strains and an increasing population of people with weakened immune systems. It is no longer uncommon to isolate
Moraxella catarrhalis
strains that are resistant to some or all of the standard antibiotics. This phenomenon has created an unmet medical need and demand for new anti-microbial agents, vaccines, drug screening methods, and diagnostic tests for this organism.
SUMMARY OF THE INVENTION
The present invention relates to BASB019, in particular BASB019 polypeptides and BASB019 polynucleotides, recombinant materials and methods for their production. In another aspect, the invention relates to methods for using such polypeptides and polynucleotides, including prevention and treatment of microbial diseases, amongst others. In a further aspect, the invention relates to diagnostic assays for detecting diseases associated with microbial infections and conditions associated with such infections, such as assays for detecting expression or activity of BASB019 polynucleotides or polypeptides.
REFERENCES:
patent: 0 281 673 (1988-09-01), None
patent: WO 95 31215 (1995-11-01), None
patent: WO 0078968 (2000-12-01), None
Rudinger et al, in “Peptide Hormones”, edited by Parsons, J.A., University Park Press, Jun. 1976, p. 6.*
Burgess et al., The Journal of Cell Biology, 111:2129-2138, 1990.*
Lazar et al., Molecular and Cellular Biology, 8(3): 1247-1252, 1988.*
Jobling et al. (Mol. Microbiol. 1991, 5(7): 1755-67.*
McMichael, 2000, Microbes and Infection 2; 561-568.*
Helminen et al 1994 (J.Infec.Dis, 170; 867-872).*
Levinson et al Medical Microbiology & Immunology 1994, p. 293.*
Accession : AX067442 search report.*
Murphy, “Branhamella catarrhalis: Epidemiology, Surface Antigenic Structure, and Immune Response”, Microbiological Reviews, Jun. 1996, pp. 267-279.
Bartos, et al., Comparison of the Outer Membrane Proteins of 50 strains ofBranhamella catarrhalis, Journal of Infectious Diseases, vol. 58, No. 4, Oct. 1988, pp. 761-765.
Lim, et al., “Molecular and Immunological Characterization of OprL, the 18 kDa, outer-membrane peptidoglycan-associated lipoprotein (PAL) ofPseudomonas aeruginosa”, Microbiology, vol. 143, No. 5, May 1997, pp. 1709-1716.
Spinola, et al., “The conserved 18,000-molecular-weight outer membrane protein ofHaemophilus ducreyihas homology to PAL”, vol. 64, No. 6, Jun. 1996, pp. 1950-1955.
Spinola, et al., “Characterization of 18,000-molecular-weight outer membrane protein ofHaemophilus ducreyithat contains a conserved surface-exposed epitope”, Infection and Immunity, vol. 60, No. 2, Feb. 1992, pp. 385-391.
International Search Report from International Application No. PCT/EP99/03038.
Baskar Padma
Meade Eric A.
Smith Lynette
SmithKline Beecham Biologicals (s.a.)
Sutton Jeffrey A.
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