Drug – bio-affecting and body treating compositions – Inorganic active ingredient containing – Phosphorus or phosphorus compound
Reexamination Certificate
2002-08-23
2003-05-20
Pak, John (Department: 1616)
Drug, bio-affecting and body treating compositions
Inorganic active ingredient containing
Phosphorus or phosphorus compound
C426S073000, C426S074000, C426S800000, C514S052000, C514S075000, C514S167000, C514S168000, C514S184000, C514S249000, C514S251000, C514S276000, C514S345000, C514S356000, C514S387000, C514S458000, C514S474000, C514S492000, C514S494000, C514S499000, C514S500000, C514S502000, C514S505000, C514S563000, C514S725000, C514S763000, C514S885000, C514S904000, C514S905000, C424S600000, C424S602000, C424S603000, C424S604000, C424S605000, C424S606000, C424S630000, C424S631000, C424S632000, C424S633000, C424S634000, C424S
Reexamination Certificate
active
06565891
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to nutritional supplements, and more particularly relates to nutritional supplements optimized for administration to children. The invention further relates to nutritional supplements optimized for enhanced immunological response in children.
BACKGROUND OF THE INVENTION
In the U.S., Canada, Western Europe, Japan, and other industrialized affluent countries, our exposure to “malnutrition” comes from the print and audiovisual media, and visual images in newspapers, magazines, and television. These highlight the problem of nutritional deficiencies that are widely observed in less developed countries and in underprivileged populations in general. In addition to protein-energy malnutrition, deficiencies of individual nutrients are widespread throughout the world. In particular, deficiencies of iron, vitamin A and iodine are endemic in some regions in all continents. It has been estimated that at least 600 million individuals suffer from such deficiencies.
It is surprising that nutrient deficiencies may also be seen in particular age groups in the U.S., Canada, and other affluent countries. Iron deficiency was very common in infants and young children but the advent of iron-fortified infant formulas and of cereals has reduced its incidence dramatically. However, these problems have not disappeared.
Factors other poverty can lead to nutrient deficiencies in children age 4-12 years. During the rapid growth phase, the needs for nutrient deficiencies are enhanced. Secondly, many children are fussy eaters and in spite of the best efforts of their parents, they do not consume an adequate amount and variety of foods.
Furthermore, it has been demonstrated recently that additional amounts of some nutrients may reduce the severity of some illnesses and reduce the number of complications.
It is now recognized that certain age groups and some physiological states require additional amounts of nutrients. A case in point is pregnancy. Pregnant women are recognized to need a greater amount of various nutrients not only to maintain their own good health but also ensure an adequate growth and satisfactory state of the unborn baby. These needs have been addressed, for example, in U.S. Pat. No. 4,994,283 directed to nutritional mineral supplements which include iron and calcium compounds in combination with citrates or tartrates, ascorbates, and fructose in an effort to reduce the tendency of calcium to inhibit the bioavailability of iron, so that the conjoint bioavailability of these two minerals is enhanced.
Another group with special nutrient needs is the elderly. Their numbers are increasing and their health needs are much greater than those of younger individuals because they are ill more often and each episode of illness, such as pneumonia or fracture, requires a longer time to recover from. It has been estimated that at least one-third of the elderly in the US and Canada and Europe have objective evidence of nutritional deficiencies. The prior art described in U.S. Pat. No. 5,556,644 addressed these concerns and special needs, and is hereby incorporated by reference.
The special nutrient needs of children are recognized. This is consequent on their rapid growth and increased needs of vitamins and minerals for various physiological systems. U.S. Pat. Nos. 5,719,133 and 5,719,134 have addressed this to some extent but these are food compositions for children with various diseases where the protein, amino acid, mineral, fat, and carbohydrate needs are very different from those of normal children. Such compositions are not for oral administration and are not directed to optimizing the health of normal children and children in need of nutritional supplementation to enhance immune responses and to prevent the problem of general malnutrition and specifically to prevent vitamin, mineral and trace element deficiencies.
SUMMARY OF THE INVENTION
The present invention overcomes the shortcomings of preparations that contain single nutrients or a combination of a limited number of nutrients. This invention is specifically tailored for administration to children age 4 to 12 years to meet their special needs, and provides a method for maintaining the optimal health and immunological function of children by administration of the same. The formulation of the invention has been found to benefits of vitamin and mineral supplementation for children and at the same time minimizing undesirable side effects that accrue from the administration of single nutrients and large doses of nutrients.
The composition of the invention is uniquely optimized to sustain physical and mental health of children age 4 to 12 years, and in particular to maximize their immunological function.
Thus, the invention provides a multivitamin, mineral and trace element supplement for administration to children age 4 to 12 years, which comprises calcium in the amount of about 255 to about 345 mg; chromium in the amount of about 17 to about 23 &mgr;g; copper in the amount of about 263.5 to about 356.5 &mgr;g; fluoride in the amount of about 0.935 to about 1.265 mg; iodine in the amount of about 76.5 to about 103.5 &mgr;g; iron in the amount of about 12.75 to about 17.25 mg; magnesium in the amount of about 25.5 to about 34.5 mg; manganese in the amount of about 1.275 to about 1.725 mg; molybdenum in the amount of about 229.5 to about 310.5 &mgr;g; phosphorus in the amount of about 255 to about 345 mg; selenium in the amount of about 85 to about 115 &mgr;g; zinc in the amount of about 5.95 to about 8.05 mg; beta-carotene in the amount of about 0.765 to about 1.035 mg; vitamin A in the amount of about 467.5 to about 632.5 &mgr;g; vitamin C in the amount of about 34 to about 46 mg; vitamin D in the amount of about 6.8 to about 9.2 &mgr;g; vitamin E in the amount of about 13.6 to about 18.4 mg; thiamin in the amount of about 1.36 to about 1.84 mg; riboflavin in the amount of about 0.935 to about 1.265 mg; niacin in the amount of about 10.2 to about 13.8 mg; vitamin B
6
in the amount of about 1.445 to about 1.955 mg; folic acid in the amount of about 204 to about 276 &mgr;g; vitamin B
12
in the amount of about 2.38 to about 3.22 &mgr;g; pantothenic acid in the amount of about 1.105 to about 1.495 mg; and biotin in the amount of about 18.7 to about 25.3 &mgr;g.
An advantage of the present invention is that the nutritional supplement of the present invention supplies the right amount of the necessary nutrients including vitamins and minerals to children to assure optimal intake of nutrients needed for health and maximal immunological response and protection against nutritional losses and deficiencies due to lifestyle factors and inadequate dietary patterns.
Another advantage of the present invention is that the nutritional supplement of the present invention provides the necessary vitamins and minerals to allow children using the supplement to maintain their present health and positively influence their future health.
Another advantage of the present invention is that the nutritional supplement of the present invention increases and/or optimizes the immunological responses of children that are users of the supplement, such immunological responses including lymphocyte response to PHA, interleukin-2, antibody response and thymulin activity.
Still another advantage of the present invention is that the nutritional supplement of the present invention reduces the occurrence of common infections in the children that are using the supplement.
These and other advantages and benefits of the present invention will be apparent to those skilled in the art upon reading and understanding the following detailed description of the invention.
REFERENCES:
patent: 4070488 (1978-01-01), Davis
patent: 4237118 (1980-12-01), Howard
patent: 4994283 (1991-02-01), Mehansho et al.
patent: 5556644 (1996-09-01), Chandra
patent: 5561160 (1996-10-01), Walaszek et al.
patent: 5571441 (1996-11-01), Andon et al.
patent: 5719133 (1998-02-01), Schmidl et al.
patent: 5719134 (1998-02-01), Schmidl et al.
patent: 5770215 (1998-06-01), M
Liniak Berenato & White
Pak John
TSAR Health Private Ltd.
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