Drug – bio-affecting and body treating compositions – Whole live micro-organism – cell – or virus containing – Bacteria or actinomycetales
Reexamination Certificate
2001-03-15
2002-04-02
Lankford, Jr., Leon B. (Department: 1651)
Drug, bio-affecting and body treating compositions
Whole live micro-organism, cell, or virus containing
Bacteria or actinomycetales
C424S093450, C424S617000, C424S780000, C435S252100, C435S252900
Reexamination Certificate
active
06365152
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a new and improved scours treatment for young animals and method of using it. More particularly, the present invention relates to a composition composed of two groups of compounds, when combined and properly administered to young animals suffering from diarrhea, infectious diarrhea, scours and dehydration, acts to rapidly relieve the symptoms associated with the disease. The compounds utilized in the two groups radically depart from conventional treatments.
2. Description of the Related Art
Cattle are a major 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 cattle are becoming increasingly important.
Calf scours complex is a worldwide malady affecting calves ranging from birth to three weeks of age with a high mortality rate in untreated cases. Dairy calves are weaned at 3 weeks to 90 days. At the time of weaning, young calves are stressed by the change in diet and other conditions. A significant percentage of calves develop diarrhea, a condition generally referred to as scours. Even in treated calves, there is still an unacceptably high rate of mortality. The loss of young livestock to this cause is a substantial burden to the livestock industry worldwide.
The disease agents are primarily Reovirus and Coronavirus with colibacillosis and Cryptosporidium sp. as contributing factors.
Escherichia coli
is also a major cause of infectious scours in calves. In addition, Salmonella sp. and Clostridium sp. groups have been found associated with outbreaks outside of North America.
Currently, a reovirus vaccine is available and an experimental Coronavirus vaccine may become available for prevention. Treatments consisting of antibiotics are used in virtually all infected herds, even when isolation of infected animals is or is not possible, or in cases where isolation has proven to be ineffective in preventing spread. Often treatment of scours with antibiotics has proven to be slow or even ineffectual. In addition, the withdrawal times required for animals may be lengthy and these antibiotic treatments are relatively expensive to administer.
The lack of response of infectious diarrhea to antibiotic treatment may be attributable to the development of resistant strains of bacteria. 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. In one particular case, a single bovine fecal sample tested positive for
E. coli,
Cryptosporidium and Rotavirus. This type of multiple etiology would make any antibiotic treatment for infectious diarrhea or white scours ineffective.
The benefits of nutritional compound formulations 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 calf scours are disclosed in U.S. Pat. Nos. 6,066,341, 5,614,501, 5,028,437 and 5,009,248.
In general, the currently used compositions used for treatment of symptoms of calf diarrhea contain one or more of the following ingredients: psyllium, amino acids, electrolytes, citrate, and complex carbohydrates. This is especially the case in preparations containing primarily electrolytes for hydration therapy. Such components are found to be useful due to the ease of storage in dry states and convenience of use when re-hydrated.
The use of glucose and electrolytes helps to reverse the effects of dehydration in affected animals. Fibrous components such as psyllium act as a water binding swelling agent in the intestines and reportedly carries with it a lactose decomposing enzyme. Amino acids such as glycine and citrate salts are added to improve palatability, ease of formulation and stability of the compounds.
The reported efficacy of these treatments vary and the mortality rate for the treatments can vary from 4% to 25% depending on the treatment used. Mortality rates in general can range as high as 50%.
Treatments for symptoms of scours in calves are known in the prior art. Such a treatment is described in U.S. Pat. No. 6,066,341. This inventive formulation includes fiber, electrolytes and three energy sources. These energy sources are sugar, medium chain triglycerides and glycine.
This novel invention, while allowing for rehydration of affected animals as well as providing an energy source, does little to fulfill the total nutritional requirements of the animals during the dosing procedure, thus utilizing the treatment period to reverse critical weight loss from nutritional deficiency.
The reported mortality of infected animals after administration of the treatment ranges from 3.4% up to 21.2%. It would be highly desirable to have a treatment with a significantly lower after treatment mortality rate.
The invention does provide for a water binding swelling agent in the intestines but does not provide for any beneficial micro-organisms to recolonize the infected intestinal tract to provide for needed vitamin and nutritional needs as soon as possible. In addition, the introduced bacteria would effectively compete with pathogenic organisms that might be present.
Therefore, it would be highly desirable to have a new and improved formulation and method for using same for a calf scours treatment which would allow rapid relief from the symptoms of diarrhea by providing a more complete nutritional regimen to reverse the effects of malnutrition resulting in 1% or less mortality post treatment and introduce beneficial micro-organisms to recolonize the affected 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 pathogenic organisms which may still be present.
The treatment described in U.S. Pat. No. 5,614,501 addresses the problem of providing for a method of decreasing the amount of harmful bacteria present in the gastrointestinal tract by incorporating polyphenols in the composition. Additionally, the composition provides for hemicelluloses which are preferably used as a nutritional source for beneficial bacteria in the gastrointestinal tract. However, in many cases, the populations of beneficial microorganisms is severely depleted. No provisions have been made in this formulation to innoculate the infected gastrointestinal tract with beneficial microorganisms.
Therefore, it would be highly desirable to have a new and improved formulation and method for using same for a calf scours treatment which would allow rapid relief from the symptoms of diarrhea by providing a more complete nutritional regimen to reverse the effects of malnutrition and introduce beneficial micro-organisms to recolonize the affected 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 pathogenic organisms which may still be present.
U.S. Pat. No. 5,028,437 describes a treatment that addresses the problem of providing for an energy source in the form of carbohydrates, electrolytes and chloride ions. However, the treatment does not address the total nutritional requirements of the animal during the treatment period when milk is withheld. When using the scours treatment that is the subject of this patent application, there is no need to withhold milk from calves during the treatment period, as is the case here for U.S. Pat. No. 5,028,437.
Therefore, it would be highly desirable to have a new and improved formulation and method for using same for a calf scours treatment which would allow rapid relief from the symptoms of diarrhea by providing a more complete nutritional regimen to reverse the effects of malnutrition and introduce beneficial micro-organisms to recolonize the affected intestinal
Bovine Health Products, Inc.
Clarke Richard D.
Lankford , Jr. Leon B.
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