Drug – bio-affecting and body treating compositions – Inorganic active ingredient containing – Peroxide or compositions of or releasing gaseous oxygen or...
Reexamination Certificate
1999-07-02
2004-03-16
Page, Thurman K. (Department: 1616)
Drug, bio-affecting and body treating compositions
Inorganic active ingredient containing
Peroxide or compositions of or releasing gaseous oxygen or...
C422S001000, C422S022000, C422S024000, C422S026000, C422S027000, C422S028000, C422S036000, C424S666000, C424SDIG006, C432S009000, C514S036000, C514S037000, C514S039000, C514S041000, C514S141000, C514S152000, C514S159000, C514S165000, C514S166000, C514S192000, C514S198000, C514S256000, C514S390000, C514S392000, C514S472000, C514S474000, C514S553000, C514S557000, C514S561000, C514S574000, C514S576000, C514S634000, C514S643000, C514S693000, C514S694000, C514S705000, C514S709000, C514S716000, C514S718000, C514S
Reexamination Certificate
active
06706290
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to methods of disinfecting articles infected with nanobacteria, and methods of treating patients infected with nanobacteria.
2. Description of the Related Art
The formation of discrete and organized inorganic crystalline structures within macromolecular extracellular matrices is a widespread biological phenomenon generally referred to as biomineralization. Mammalian bone and dental enamel are examples of biomineralization involving apatite minerals. Environmental apatite stones have almost the same chemical composition as in bone and dentine. Recently, bacteria have been implicated as factors in biogeochemical cycles for mineral formation in aqueous sediments. The principal constituent of modern authigenic phosphate minerals in marine sediments is carbonate (hydroxy)fluorapatite Ca
10
(PO
4
)
6−x
(CO
3
)
x
(F,OH)
2+x
. Microorganisms are capable of depositing apatite outside thermodynamic equilibrium in sea water. They can segregate Ca from Mg, and actively nucleate carbonate apatite by means of specific oligopeptides under conditions pH <8.5 and [Mg]:[Ca]>0.1. Such conditions are also present in the human body.
Nanobacteria approach the theoretical limit of the self-replicating life with a size of only one hundredth of that of usual bacteria. Nanobacteria can be isolated from mammalian blood and blood products (see, U.S. Pat. No. 5,135,851 to Kajander, the contents of which are incorporated herein by reference). Energy-dispersive X-ray microanalysis and chemical analysis reveals that nanobacteria produce biogenic apatite on their cell envelope. The thickness of the apatite depends mostly on the culture conditions of the nanobacteria. Nanobacteria are the smallest cell walled, apatite forming bacteria isolated from mammalian blood and blood products. Their small size (0.05-0.5 &mgr;m), and unique properties make their detection difficult with conventional microbiological methods. In nanobacteria-infected mammalian cells, electron microscopy revealed intra- and extracellular acicular crystal deposits, stainable with von Kossa staining and resembling calcospherules found in pathological calcification.
The present inventors have discovered nanobacteria in human and cow blood that are cytotoxic in vitro and in vivo. They have been deposited in DSM, Braunschweig, Germany at accession No. 5819-5821. Human and bovine nanobacteria grow similarly, share the same surface antigens, and other special features. They both produce carbonate apatite as well. Nanobacteria possess unusual properties making their detection difficult with standard microbiological methods. Although they typically have diameters of 0.2-0.5 &mgr;m, they also exist in tiny forms (0.05-0.2 &mgr;m) as observed using transmission electron microscopy (TEM). Thus nanobacteria manage to pass through 0.1 &mgr;m filters. Nanobacteria are poorly disruptable, stainable, fixable and exceptionally resistant to heat. Their doubling time is about 3 days. High doses of &ggr;-irradiation or aminoglycoside antibiotics prevented their multiplication. According to the 16S rRNA gene sequence (EMBL X98418 and X98419), nanobacteria fall within the &agr;-2 subgroup of Proteobacteria, which also includes Brucella and Bartonella species. The latter genera include human and animal pathogens that share similarities with nanobacteria, e.g., some of the same antigens and cytopathic effects.
Competition for nutrients necessary for life is enormous in natural environments and thus clever adaptations and survival strategies for unfavorable conditions are needed. Bacteria can form spores, cysts and biofilm, which help them survive unfavorable periods of time. Bacteria in such forms have significantly slower metabolic functions, but vegetative cells can slow down their metabolism as well. The increased resistance of bacteria in biofilm or as spores is not only because of the slower metabolic rate. The impermeable structures around the organism serve as mechanical barriers blocking the entrance of potentially harmful compounds. Some additional mechanisms are also known which help in the survival of bacteria. The heat resistance of bacterial spores can be attributed to three main factors, these are protoplast dehydration, mineralization and thermal adaptation. Radiation resistance is commonly associated with sophisticated DNA repair systems. Minimizing metabolic rate and multiplication are obviously the main preconditions for bacterial survival, allowing time for the repair of DNA and other damaged cellular components. Very slow metabolism, and ability to form biofilm are also characteristics of nanobacteria. Because of their minimal size, the presence of complicated systems for nucleic acid repair in nanobacteria seems very unlikely. A possible explanation for the observed gamma irradiation resistance may be their very small size, and the peculiarities in their nucleic acid structure.
Apatite may play a key role in the formation of kidney stones. The crystalline components of urinary tract stones are calcium oxalate, calcium phosphate, struvite, purines, or cystine. The majority of urinary stones are admixtures of two or more components, with the primary admixture being calcium oxalate and apatite. Furthermore, fermentor model studies have shown that calcium phosphate nidi are always formed initially, and may subsequently become coated with calcium oxalate or other components. Urinary tract infection, causing struvite and carbonate apatite formation, is a common cause of kidney stones. Conventional therapy has usually consisted of surgical removal of the stone, combined with a short course of antimicrobial therapy. Such treatment is curative in about 50% of cases. Recurrent stone formation and progressive pyelonephritis occur in those who are not cured. The morbidity and expense that result from this disease is significant.
Tissue calcification of carbonate apatite in nature is common in other diseases, e.g., atherosclerotic plaques accumulate calcium phosphate. 25% of atherosclerotic plaques in human aorta specimens were found to contain nanobacterial by immunoassay and immunohistochemical staining. Hemodialysis patients can develop extensive metastatic and tumoral calcification. Acute periarthritis is apatite arthropathy related to intratendinous calcifications. Apatite crystals also cause inflammation when injected into the synovial space. Tissue calcification is also found in several kinds of cancer.
Pulp stones or denticles are polymorphous mineralized bodies of various sizes occasionally found in the pulpal connective tissue of human teeth. Their etiology remains unclear although they have been frequently associated with aging or pathology of the pulp. They may also be present in permanent teeth that are impacted free of pathology for a long time. Although pulp stones have been extensively studied morphologically, their origin is still obscure and little is known about their chemical composition. An histochemical study of pulpal calcifications has shown that the organic matrix consists of reticular connective tissue fibers and a ground substance containing glycoproteins and acid polysaccharides. The mineral phase of pulp calcification has been studied with X-ray energy dispersive spectrometry and chemical analysis, and proven that calcium salts are deposited in the form of apatite, possibly carbonate containing apatite. In fact, there is not much difference between the chemical structure of a tooth and denticles. Bone and tooth formation in the body have similar mechanisms, leaving many unanswered questions. Apatite formation in the body (except in tooth and bone) is called pathologic biomineralization, e.g., dental pulp stones, kidney stones, and joint calcifications.
Malacoplakia is a rare chronic inflammatory disease of unknown cause, but a bacterial factor has been strongly implicated. It may be fatal. The disease is characterized by von Kossa staining positive, calcified laminated or target-shaped bodies termed Michaelis
Ciftcioglu Neva
Kajander Olvai E.
Burns Doane Swecker & Mathis L.L.P.
Choi Frank
Page Thurman K.
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