Organic compounds -- part of the class 532-570 series – Organic compounds – Carbohydrates or derivatives
Reexamination Certificate
1998-11-02
2001-07-03
Smith, Lynette R. F. (Department: 1645)
Organic compounds -- part of the class 532-570 series
Organic compounds
Carbohydrates or derivatives
C536S023700, C536S024330, C536S024300, C435S069100, C435S071100
Reexamination Certificate
active
06255467
ABSTRACT:
BACKGROUND OF THE INVENTION
Field of the Invention
The present invention relates generally to bacteriology and human pathology. More specifically, the present invention relates to a bacterium present in the human blood, the characterization, culturing and diagnostic methodologies therefor and the treatment of pathophysiological states caused by this bacterium.
Description of the Related Art
Infectious agents are a main cause of human disease and the leading cause of death worldwide. Bacterial infections are cause more deaths than any other class of infectious organisms. The single leading cause of death via infectious organisms worldwide remains tuberculosis, caused by the bacterium Mycobacterium tuberculosis; however scores of diseases or disorders caused by infectious agents are present in both developed and undeveloped countries.
Examples of infectious disorders include chronic fatigue syndrome and conditions such as fibromyalgia. These disorders affect about 1,000,000 Americans. There is no known cause or effective treatment for these conditions, nor is there any definitive diagnostic laboratory test. Epidemiologic evidence suggests an infectious agent as the cause; however, no causative infectious agent has been identified.
Multiple sclerosis produces disability to variable degrees and occasional death in about 400,000 Americans. Multiple sclerosis is a disease of unknown cause and has considerable variability, with minimal disability in some patients and almost total disability in others. As with chronic fatigue syndrome, there is no definitive diagnostic laboratory test, and clinical diagnosis is based on a constellation of symptoms and tests. Epidemiologic data suggests that multiple sclerosis has an underlying infectious cause and that the infectious cause is acquired years prior to the development of symptoms.
Another loosely-defined group of diseases are those in the “autoimmune” category such as lupus erythematosis and rheumatoid arthritis. These relatively common diseases are often disabling and the underlying cause of these diseases is unknown. Rheumatoid arthritis is rarely fatal, but lupus erythematosis has a significant mortality rate. Laboratory diagnostic tests for these conditions are satisfactory, but no test is definitive, so a variety of tests in combination with the correlation of clinical symptoms is necessary. A variety of medications are available to control symptoms to some degree and slow progression of the diseases, but no treatment is curative. Certain antibiotics are currently accepted as one therapeutic option for rheumatoid arthritis, but no specific infectious cause has been demonstrated.
Thus, the prior art is deficient in the identification and characterization of the specific bacterium from human blood described herein, methods for culturing it and for diagnosing and treating diseases that result from an increase in the presence of the bacterium in an individual's blood. The present invention fulfills this long-standing need and desire in the art.
SUMMARY OF THE INVENTION
One object of the present invention is to provide a culture system for the human blood bacterium (HBB) described herein. One approach to this culture system is to provide a method for culturing HBB, comprising the steps of: isolating HBB from a sample; adding a medium comprising salts, at least one sugar, and lactalbumin hydrolysate; and incubating said HBB at a temperature which allows for growth of said HBB.
In one embodiment of the present invention, there is provided a method for culturing HBB, comprising the steps of: isolating HBB from a sample; adding a medium comprising CaCl
2
; MgCl
2
(anhydrous); KCl; NaCl; NaH
2
PO
4
(monobasic); lactalbumin hydrolysate; yeast extract, lactose; manganese chloride; and a buffer selected from the group of sodium bicarbonate, Tris, and HEPES; and incubating said HBB at a temperature which allows for growth of said HBB. In a preferred embodiment, the culture medium further contains sodium arachidonate and lipoxidase.
In yet another embodiment of the present invention, there is provided a method for culturing HBB, comprising the steps of: isolating HBB from a sample; adding a medium comprising CaCl
2
; MgCl
2
(anhydrous); KCl; NaCl; NaH
2
PO
4
(monobasic); lactalbumin hydrolysate; yeast extract; manganese chloride; and a sugar selected from the group of glucose, fructose, and sucrose; and incubating said HBB at a temperature which allows for growth of said HBB.
An additional object of the present invention is to provide methods of diagnosing a pathophysiological state in an individual that results from an increase in the presence of the human blood bacterium (HBB) in an individual's blood. Additionally, the methods can be used to identify individuals at risk for developing a pathophysiological state or for monitoring progress of treatment for disease. The methods make use of antibodies capable of reacting with HBB and polynucleotides capable of duplexing with the HBB genome. Infection may be detected by various techniques, particularly nucleic acid hybridization and immunoassays.
In another embodiment of the present invention, there is provided a method for diagnosing a pathophysiological state in an individual resulting from an imbalance in a presence of HBB in the individual's blood, comprising the step of determining a count of HBB from blood of the individual, and comparing the counts between the test and control individuals, wherein the control individual is known to be healthy. If the count of test individual is greater than that of control individual, the test individual has abnormal levels of HBB in its blood. Otherwise, the test individual has normal levels of HBB. Preferably, the count from control individual is no greater than 400/HPF (High power field) after growing its blood for 1 week in medium O or modified RPMI medium. The methods for making this determination include, but are not limited to, a technique selected from the group of quantification by a solid or liquid culture; ELISA assay; flow cytometry; TAQ man; Western blot hybridization; antibody-based tests and nucleic acid-probe based tests including PCR and in situ hybridization. Specifically, probes for in situ hybridization are selected from the group consisting of SEQ ID No: 19 and SEQ ID No:20. Primers used for PCR are selected from the group consisting of SEQ ID Nos: 7-18.
A further object of the present invention is to treat a pathophysiological state that results from an increase in the presence of the bacterium in an individual's blood. In one embodiment of the present invention, there is provided a method for treating a pathophysiological state that results from an imbalance in a presence of HBB in an individual's blood, comprising the step of administering to said individual a therapeutically effective amount of at least one antibiotic from the group consisting of penicillin G, penicillin V, primaquine, Augmentin, dicloxacillin, Ciprofloxacin, Isoniazid, third-generation cephalosporins, azithromycin, clarithromycin, chloroquin, hydroxychloroquin, minocycline, doxycycline. In a preferred embodiment, the antibiotic is administered with a therapeutically effective amount of one or more substances from the group consisting of probecid, Nystatin, Nizoral, Diflucan, steroids, vitamin B-
6
, vitamin C, folic acid, vitamin E, niacin, chromium, zinc, sulfhydryl compounds, steroids, and ibuprofen.
In yet another embodiment of the present invention, there is provided a vaccine generated from HBB or components thereof.
In still yet another embodiment of the present invention, there is provided a method of treating an individual with a disease where toxic metabolites are accumulated in its plasma or serum by administering engineered HBB to the individual. Preferably, the engineered HBB expresses therapeutical gene products selected from the group consisting of hormones, growth regulators, antitumor antigens, antibodies, interleukins and other therapeutical antigens.
Still another project of the present invention is to characterize this
Lindner Luther E.
MacPhee Kathleen
Adler Benjamin Aaron
Lee Li
Pathobiotek Diagnostics Inc.
Smith Lynette R. F.
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