Drug – bio-affecting and body treating compositions – Extract – body fluid – or cellular material of undetermined... – Milk or colostrum
Reexamination Certificate
2001-04-30
2003-01-14
Lankford, Jr., Leon B. (Department: 1651)
Drug, bio-affecting and body treating compositions
Extract, body fluid, or cellular material of undetermined...
Milk or colostrum
C424S529000, C424S093510, C424S093450, C424S600000, C514S168000, C514S052000, C514S167000, C514S251000, C514S276000, C514S458000, C514S474000, C514S725000
Reexamination Certificate
active
06506413
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to compositions of transfer factor in combination with specific nutraceuticals and to the use of these compositions in treating diseases and syndromes.
BACKGROUND OF THE INVENTION
Transfer factor which is produced by leucocytes and lymphocytes are small water soluble polypeptides of about eight amino acids and also associated cofactors that stimulate or transfer cell mediated immunity from one individual to another and across species. Since transfer factors are smaller than antibodies, they do not transfer antibody mediated responses nor do they induce antibody production. The properties, characteristics and processes for obtaining transfer factor or transfer factors are discussed in U.S. Pat. Nos. 4,816,563; 5,080,895; 5,840,700 and 5,883,224, the contents of which are hereby incorporated by reference into the present application. Transfer factor has been described as an effective therapeutic for Herpes simplex virus (Viza, et al.), a treatment for acne blemishes, U.S. Pat. No. 4,435,384 and as a treatment against
C. albicans
(Khan et al.). Transfer factor has also been used to treat intestinal cryptosporidiosis in recipients treated with specific transfer factor (McMeeking, et al.). Still, et al. also showed that chicken pox infections were prevented by pretreatment of children treated with transfer factor from individuals that had chicken pox or who in other words had been sensitized to the varicella antigen. It may be assumed that the individual or animal that is the source of the transfer factor has been sensitized to the antigen of interest. The term antigen is defined herein is anything that will initiate the cell mediated immune response. However, transfer factor as found in commercial bovine colostrum extract coming from a pool of animals (e.g., cows) contains the acquired immunity from all of the pool and therefore provides a type of generalized adoptive transfer of immunity. Transfer factors or transfer factor can be obtained from a dialyzable extract of the lyzed cells or from an extract of extracellular fluid containing transfer factor. Common sources of transfer factors are colostrum, ova, blood and milk. It is common practice to refer to preparations that contain transfer factor by the name of the active component (i.e., transfer factor). Transfer factor extract containing transfer factors is also herein referred to as transfer factor. Transfer factor from bovine colostrum extract is defined as defatted water soluble material from colostrum that will pass through a nominal 10,000 molecular weight filter.
The use of nutraceuticals to treat vitamin and mineral deficiencies is well known. However, the use of nutraceuticals, such as vitamins, minerals and other nutritional components to prevent and treat diseases other than those caused by the deficiency of those nutraceuticals, though still controversial, is receiving more consideration from both laymen and physicians. The following is a list of nutraceuticals and some of their generally acknowledged nutritional and health benefits.
Vitamin A—is important in preventing eye epithileol disorders; deficiency results in night blindness
Vitamin B
2
—is essential to human nutrition relating to the oxidation of carbohydrates and amino acids
Mixed tocopherols—are antioxidants
Choline Chloride—is a member of the vitamin B complex and a dietetic factor for furnishing free methyl groups for transmethylation
Vitamin B
6
—functions in the formation and breakdown of amino acids and is involved in the synthesis of serotonin and norepinephrine. However, exact dietary requirements are uncertain
Vitamin B
12
—is an antipernicious-anemia factor essential for normal hemopoiesis
Vitamin E—is an antioxidant that protects against free radicals.
Vitamin K—is essential for the formation of prothrombin
Biotin—functions in metabolic processes leading to the formation of fats and utilization of carbon dioxide
Folic Acid—a growth factor involved in the formation of nucleic acids and necessary for the formation of heme
Niacin—a component of the Vitamin B complex, a deficiency results in pellagra
Vitamin D
3
—is important in the absorption of calcium
Pantothenic Acid—is considered essential for growth and well being of animals; deficiency results in growth retardation, skin lesions and graying of hair
Thiamine—is necessary in diet of all animals except ruminants; used to prevent beriberi and important in carbohydrate metabolism
Lysine—is an essential amino acid
Methionine—is a sulfur containing essential amino acid
Arginine—is an amino acid important in the synthesis of urea (principal form in which mammals excrete)
Soy—is a source of proteins
Methyl Sulfonyl Methane—is a form of organic sulfur involved in cell membrane permeability
Zinc—is an essential mineral for growth; deficiency creates susceptibility to various pathogens
Omega 3-, 6-, and 9-Fatty Acids—are essential fatty acids and polyunsaturated fats; a deficiency results in hypertension and high blood pressure; they are believed to improve immune function
Yeast—(e.g., brewers, bakers, etc.) contains beta glucans which appear to increase production and/or activation of natural killer cells
Calcium—is required for bone development
Phosphorus—is required for bone development
Selenium—a deficiency results in heart muscle disease
Iron—is required for formation of hemoglobin; deficiency results in anemia
Magnesium—is an element required for growth in all living organisms
Manganese—is an element required for growth in all living organisms
Copper—is an element required for growth in plants, animals and most microorganisms
Iodine—is an element necessary for the synthesis of hormone production by the thyroid gland
Cobalt—is a trace element essential in the nutrition of ruminants (cattle, sheep) and in the maturation of human red blood cells in the form of Vitamin B
12
Molybdenum—is a trace element believed to be necessary in animal diets but its function in the minimal levels have not been established
Lactic Acid Generating Bacteria—are a digestive aid and growth inhibitor of harmful bacteria
Chrondroitin—is a component of connective tissue which may relieve joint pain and arthritis.
Glucosamine—is a component of micropolysaccharides and glycoprotein which may be helpful in arthritis.
Di-methyl glycine—is a methylated amino acid found in all cells and an antioxidant.
Montmorillonite—is collodial clay containing trace elements which are considered by some to be important for well being and to compensate for elements no longer in foods because of depleted soils (the components are shown below in Table 1)
TABLE 1
Montmorillonite Components
Average Nutrient Content Per Ounce
(1 Tablespoon = 0.36 oz.)
(mg)
Silicon
6933
Tungsten
0.218
Aluminum Silica
2505
Vanadium
0.215
Sodium Chloride
1320
Ruthenium
0.210
Potassium
1293
Baron
0.189
Protein
1116
Bromine
0.140
Calcium
1104
Cobalt
0.129
Sulfur
431
Selenium
0.110
Iron
431
Syprosium
0.107
Magnesium
224
Fluorine
0.102
Chlorine
164
Scandium
0.0997
Titanium
61.9
Samarium
0.0943
Carbon
48.2
Nobelium
0.0754
Sodium
37.2
Copper
0.0593
Barium
10.5
Praseodymium
0.0539
Phosphate
8.62
Erbium
0.0539
Strontium
6.46
Hafnium
0.0539
Cesium
4.93
Ytterbium
0.0377
Manganese
4.04
Lithium
0.0377
Thorium
2.69
Yttrium
0.0323
Uranium
2.69
Holmium
0.0296
Arsenic
1.97
Cadmium
0.0296
Chromium
1.89
Palladium
0.0189
Molybdenum
1.64
Terbium
0.0161
Nickel
1.62
Thulium
0.0161
Iodine
1.28
Gold
0.0161
Lead
1.17
Tantalum
0.0135
Cerium
1.08
Iridium
0.0135
Rubidium
0.983
Lutetium
0.0108
Antimony
0.781
Europium
0.0108
Gallium
0.673
Rhodium
0.0108
Germanium
0.673
Tin
0.0108
Neodymium
0.539
Silver
0.00808
Zinc
0.539
Indium
0.00808
Lanthanum
0.486
Oxygen
0.00539
Bismuth
0.385
Mercury
0.00269
Zirconium
0.269
Tellurium
0.00269
Rhenium
0.269
Beryllium
0.00269
Thallium
0.269
Allopathic medicine is usually used to treat animal diseases. Unfortunately, such medicines often have serious side effects such as nausea, gastritis, diarrhea, maladsorption of vitamins, circulation and respiratory problems and allergic reactions. For example, Cushings dis
Davis Ruth
Dorsey & Whitney LLP
Lankford , Jr. Leon B.
Trecartin Richard F.
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