Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Heterocyclic carbon compounds containing a hetero ring...
Reexamination Certificate
1999-05-03
2003-05-27
Travers, Russell (Department: 1617)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Heterocyclic carbon compounds containing a hetero ring...
C514S252140, C514S345000, C424S682000
Reexamination Certificate
active
06569857
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention is directed to novel nutritional compositions, particularly nutritional compositions for men and women planning to conceive children, and methods of using said compositions prior to and during pregnancy to augment the possibility of conception occurring and/or increase nutritional stores for aiding the development of healthy embryos and child growth.
2. Description of the Related Art
Infertility is a serious problem in the United States and throughout the world, in both industrialized and unindustrialized nations. In the United States alone, infertility affects an estimated 20 million families (i.e., approximately 20% of all U.S. families). See
The Merck Manual
, 1768 (16
th
Ed. 1992). In about 40% of these cases, the infertility is attributable to the male and in about 40-50% of these cases, the infertility is attributable to the female (note: the cause of infertility in about 10-20% of the cases is indeterminate). See McGraw-Hill
Encyclopedia of Science and Technology
, 17:417 (6
th
Ed. 1987).
Evidence indicates that the general health of both males and females prior to conception has a direct impact upon the ability to conceive. See
Understanding Nutrition
, 479-480 (Whitney and Rolfes eds., 6
th
Ed., 1993). Further, studies of both men and women have shown that the underlying cause of infertility in a marked proportion of individuals may be attributed to a nutritional factor. See Id. In fact, it has been suggested that the inability to reproduce is one of the first signs of imperfect nutrition. See Id.
Infertility in men is primarily associated with low sperm count, decreased sperm motility, sperm agglutination, impotence and ejaculatory disorders. See
The Merck Manual
, 1768 (16
th
Ed. 1992). Animal studies suggest that dietary ascorbate (vitamin C) levels directly affect sperm quality and influence male fertility in scurvy-prone vertebrates. It is believed that high concentrations of ascorbic acid in semen play a key role in maintaining the genetic integrity of sperm cells by preventing oxidative damage to sperm DNA. See Dabrowski, “Ascorbic acid protects against male infertility in teleost fish”,
Experientia
, 52(2):97-100 (1996). There is also evidence that daily vitamin C therapy is useful in the treatment and/or mitigation of decreased sperm motility and agglutination. Gonzalez, “Sperm swim singly after vitamin C therapy”,
JAMA
, 249(20):2747, 2751 (1983).
Various studies suggest that vitamin E is also effective in treating male infertility. For example, one study involving the oral dosing of vitamin E over a three month period resulted in a 50 percent increase in spermatozoal zona binding. See Kessopoulou, “A double-blind randomizing placebo cross-over controlled trial using the antioxidant vitamin E to treat reactive oxygen species associated male infertility”,
Fertil Steril
, 64(4): 825-31 (1995). Another study found that treatment of male infertility patients with oral vitamin E significantly decreased malondialdehyde concentrations, high levels of which are indicia of decreased sperm motility. Suleiman, “Lipid peroxidation and human sperm motility: protective role of vitamin E”,
J Androl
, 17(5):530-7 (1996); See also, Vezina, “Selenium-vitamin E supplementation in infertile men. Effects on semen parameters and micronutrient levels and distribution”,
Bio Trace Elem Res
, 53(1-3):65-83 (1996).
Infertility in women is primarily associated with dysfunction of ovulation, abnormal fallopian tube function and low cervical mucus receptivity.
The Merck Manual
, 1770-1772 (16
th
Ed. 1992). Infertility in women has also been linked to abnormally low red cell magnesium levels, and such cases have been successfully treated with dietary supplementation of oral magnesium. See Howard, “Red cell magnesium and glutathione peroxidase in infertile women-effects of oral supplementation with magnesium and selenium”,
Magnes Res
, 7(1):49-57 (1994).
For women planning to conceive children, the role of nutrition is not limited to infertility alone. A mother's body provides the environment in which development of the embryo and fetus occur. See
Understanding Nutrition
, 479-480 (Whitney and Rolfes eds., 6
th
ed., 1993). Accordingly, a mother's nutritional status prior to conception directly impacts the development of the fetus and embryo and is therefore implicated in the risk of birth defects. See Id.
In particular, during the first 20-25 days of pregnancy, the placenta is not yet formed and fetal circulation is not yet established. Therefore, during this period the fetus is nourished via digested maternal uterine cells and the diffusion of blood exudates. See Schorah, “Importance of Adequate Folate Nutrition in Embryonic and Early Fetal Development,”
Vitamins and Minerals in Pregnancy and Lactation
, 167-176 (Berger, ed., Vol. 16, 1988). Thus, it has been suggested that good nutrient supply is not only required in the very early stages of pregnancy, but also in the preconceptional period. See Id. It is believed that a good nutrient supply during the preconceptional period and first 20 to 25 days of pregnancy (i.e., the “histiotrophic nutritional phase”) is necessary to provide optimal concentrations of essential micronutrients to the endometrium, into which the embryo will embed. See Id. Further, inadequate nutrition prior to and at the time of conception causes the placenta, the function of which is to nourish the developing fetus, to develop incorrectly. “Transplacental Nutrient Transfer and Intrauterine Growth Retardation,”
Nutrition News
50 (1992): 56-57.
Increased occurrences of birth defects have been linked to inadequate nutrition in women at the time of conception. Cases of infants born with neural tube defect (NTD), i.e., spina bifida and anacephaly, have been documented in women with various nutritional deficiencies, primarily low blood folic acid and vitamin C concentrations. Smithells, “Vitamin deficiencies and neural tube defects”,
Arch Dis Child
51:944-50 (1976).
Various studies point to a correlation between certain vitamin and mineral deficiencies and the etiologies of specific disease states in humans. See, e.g., Diplock, “Antioxidant Nutrients and Disease Prevention: An Overview,”
Am. J. Clin. Nutr
., 53:189-193 (1991);
Documenta Giegy Scientific Tables
, 457-497 (Diem and Cemtuer eds., 7
th
ed., 1975). In particular, studies designed to test the causal relationship between specific micronutrient deficiencies and resulting birth defects elucidate a correlation between proper folic acid and vitamin C levels and the reduction in the recurrence of NTD in the instances where women have experienced at least one prior pregnancy resulting in a child with NTD. See Schorah, “Importance of adequate folate ntrition in embryonic and early fetal development”,
Vitamins and Minerals in Pregnancy and Lactation
, 167-176 (Berger, ed., Vol. 16, 1988).
Multi-vitamin and mineral supplements for treating specific medical conditions and as general nutritional supplements to promote and maintain good health have been described in various references. In particular, compositions and methods for optimizing the general health of both men and women by supplementing the daily diet with specific and multi-vitamin compositions are disclosed in the following references.
Jansen, U.S. Pat. No. 4,945,083, describes multi-factor hematinic vitamin preparations which provide B
12
and folic acid in a one to one ratio in fully effective daily dosage amounts.
Mehansho, U.S. Pat. No. 4,994,283, describes nutritional mineral supplements comprised of iron compounds and calcium compounds in combination with citrates or tartrates, ascorbates, and optionally, fructose, such that the tendency of calcium to inhibit the bioavailability of iron is reduced, and the conjoint bioavailability of these two important minerals is enhanced.
Briggs et al., U.S. Pat. No. 4,752,479 also describes a multi-vitamin and mineral dietary supplement composition for oral administration. The supplement contains one or more
Hermelin Marc S.
Levinson R. Saul
Drugtech Corporation
Nath Gary M.
Nath & Associates PLLC
Travers Russell
Wang Shengjun
LandOfFree
Dietary supplement does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Dietary supplement, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Dietary supplement will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3085023