Drug – bio-affecting and body treating compositions – Whole live micro-organism – cell – or virus containing – Bacteria or actinomycetales
Reexamination Certificate
2001-09-28
2003-12-09
Lankford, Jr., Leon B. (Department: 1651)
Drug, bio-affecting and body treating compositions
Whole live micro-organism, cell, or virus containing
Bacteria or actinomycetales
C424S076500, C424S076600, C424S076800, C424S439000, C424S442000, C424S813000, C424S814000, C424S815000, C424S823000, C424S824000, C424S825000, C424S829000, C435S252100, C435S822000
Reexamination Certificate
active
06660262
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a new and improved broad spectrum antimicrobial compound for use in treatment of bacterial and viral infections in cattle, horses, pigs, sheep, goats, dogs, cats and other domestic and non-domestic animals and the method of making and using it. More particularly, the present invention relates to a composition formulated from two groups of compounds, when combined and properly administered to infected animals suffering from a broad spectrum of pathogens including fungal, viral or bacterial infections, acts to rapidly relieve the symptoms associated with those infections and diseases. The compounds utilized in the two groups radically depart from conventional treatments.
2. Description of the Related Art
Cattle, pigs, sheep and other domestic animals are a widely used source of protein and wealth in a major portion of the world today. With a number of third world countries struggling to feed a growing number of impoverished people, affordable, efficient treatments for common diseases of domestic as well as non-domestic animals are becoming increasingly important.
One such disease affecting domesticated animals which is of great concern is foot and mouth disease (FMD). FMD is considered to be the most economically devastating livestock disease in the world. Although the United States as well as Central America, Australia, New Zealand and Chile as well as some countries in Europe are considered free of, local, state and federal agencies are on heightened alert against outbreaks of the disease. There have been reports of various types of foot and mouth disease virus in Africa, South America, Asia and part of Europe. The U.S. Department of Agriculture has prohibited the importation of live swine and ruminants and any fresh swine or ruminant meat or products from Great Britain or Northern Ireland and is retroactive to January 2001. In addition, enhanced surveillance of travelers coming from Europe is being enforced. This has potentially devastating ramifications for the economies of those countries as well as presenting a high cost for other countries in terms for surveillance and enforcement of import restrictions.
Foot and mouth disease is a highly contagious and economically devastating disease which may infect cattle, swine, sheep, goats, deer and other cloven-hoofed ruminants. Many affected animals recover, but the disease leaves them debilitated. The disease may cause losses in production of meat and milk and because it spreads rapidly, it is one of the diseases that livestock owners dread most. An outbreak could cost billions of dollars in losses in the first year. The most serious effects of the disease in dairy cattle are loss of milk and yield.
The disease is caused by a virus which can be spread by animals, people, or materials that bring the virus into physical contact with susceptible animals. There are seven different types and more than 60 subtypes of FMD virus, and there is no universal vaccine against the disease. Animals that receive the vaccine usually develop some degree of protection against clinical signs of FMD within 7 to 8 days. Any wide-scale vaccination program would be extremely costly to undertake and would have minimal effects against any strains that were not included in the vaccination series.
The longstanding response to foot and mouth disease includes eradicating the disease by depopulating affected and exposed animals. After confirmation of an outbreak, infected or exposed animals would be quarantined and destroyed.
Foot and mouth disease is only one of a long list of diseases which affect domesticated and wild animals in the United States as well as the world. FMD can also be confused with several similar but less harmful diseases such as vesicular stomatitis, bluetongue, bovine viral diarrhea, and foot rot in cattle, vesicular exanthema of swine, and swine vesicular disease.
Other foreign diseases of concern to livestock producers include African swine fever, African horse sickness, bovine spongiform encephalopathy, classical swine fever, contagious bovine pleuropneumonia, exotic Newcastle disease, Rift Valley fever, rinderpest and swine vesicular disease, among others. In addition, there are numerous domestic diseases that represent suffering for domestic animals as well as economic hardships for owners. In addition, several diseases threaten the fragile existence of endangered species as well. These diseases cause untold hardships on third world countries including contributing to the suffering of inhabitants of already drought and disaster stricken areas of the world least able to afford expensive antibiotic treatments.
As previously discussed, vaccination against most bacterial, viral and fungal infections affecting domestic and non-domestic animals is usually not employed because the cost of vaccination programs is prohibitive. Because of the number of serotypes of pathogenic species, vaccination may not be an effective preventative measure against even one disease causing agent.
Another factor in the treatment of bacterial, viral and fungal infections affecting domesticated and non-domesticated animals is the rise in antibiotic resistant strains. These antibiotic resistant strains of bacteria and other infectious agents are becoming an increasing threat to livestock and are posing a threat to other species as well. In addition, infection by multiple agents causing similar symptoms might render such treatments ineffective. Results from diagnostic laboratories have indicated that several etiologic agents can be simultaneously associated with one afflicted animal. This type of multiple etiology may make any antibiotic treatment ineffective.
The benefits of antimicrobial compounds designed for ameliorating the symptoms of the disease are well known. Examples of different types and kinds of compositions and techniques for treatment of symptoms of various diseases are disclosed in U.S. Pat. Nos. 6,197,763 and 4,782,048.
Antimicrobial treatments for symptoms of viral, bacterial and fungal diseases are known in the prior art. Such a treatment is described in U.S. Pat. No. 6,197,763. This inventive formulation includes dietary metals, selected from zinc, copper, cobalt, manganese and iron and a dietary ligand, either lawsone or topolone. The formulation specifically treats gastrointestinal symptoms and gastrointestinal microbes.
This novel invention was used in conjunction with standard antibiotic therapy which included amoxicillin in clinical trials. While in vitro tests against Helicobacter pylori indicated antimicrobial activity, it is unclear from field studies as to the effectiveness of the novel compound without the addition of the standard antibiotic treatment. It is also unclear as to the length of time from the beginning of treatment to the relief of symptoms from the information provided.
The presence of the amoxicillin also means that normal intestinal flora is probably destroyed as well as the infecting organism. The normal intestinal flora are crucial for proper nutrition for the animal during a period of time when the body is being particularly stressed.
Additionally, tropolone is known to be an amino glycoside inactivating enzyme. Lawsone is an RNA/DNA antimetabolite. Both of these compounds are known to have antibiotic properties. While these compounds may be found in extracts of naturally occurring products, the purified compounds themselves are relatively expensive.
Therefore, it would be highly desirable to have a new and improved broad spectrum antimicrobial compound for use in treatment of bacterial, fungal and viral infections in cattle, horses, pigs, sheep and other domestic and non-domestic animals which would allow rapid relief from the symptoms, which would not depend upon standard antibiotic treatment and which would introduce beneficial micro-organisms to recolonize the intestinal tract in order to provide for needed vitamin and nutritional needs of the animal and provide a bacterial population that would effectively compete with pathog
Bovine Health Products, Inc.
Clarke Richard D.
Lankford , Jr. Leon B.
Ware Deborah K.
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