Drug – bio-affecting and body treating compositions – Inorganic active ingredient containing – Selenium or compound thereof
Reexamination Certificate
2001-10-18
2003-04-29
Weber, Jon P. (Department: 1651)
Drug, bio-affecting and body treating compositions
Inorganic active ingredient containing
Selenium or compound thereof
C564S001000, C514S706000, C424S725000
Reexamination Certificate
active
06555140
ABSTRACT:
FIELD OF THE INVENTION
The invention is in the field of male fertility and relates to a composition and method of enhancing male fertility and libido. More particularly, the invention concerns compositions comprising spermine, spermidine and/or selenium and methods of enhancing male fertility with such compositions.
BACKGROUND OF THE INVENTION
Male infertility has been increasingly recognized as a major health concern. Infertility affects an estimated 1 in 5 couples in the United States. (The Merck Manual, p. 1768 (16th Ed. 1992)). About 40 percent of infertilities are due to male deficiency. Infertility refers to the inability to conceive during the course of normal sexual activity. However, a couple is generally not regarded as infertile until they have failed to conceive after one year of unprotected intercourse. Diagnosis and treatment of infertility requires a thorough assessment of both partners (The Merck Manual, p. 1768 (16th Ed. 1992)). The male deficiency most commonly responsible for infertility is a deficiency of sperm production in quantity or quality. (McGraw-Hill Encyclopedia McGraw-Hill Encyclopedia of Science and Technology, p. 417 (6th Ed. 1987). Male infertility has been treated in a miriad of ways including increasing the intracellular synthesis of glutathione within the reproductive system (U.S. Pat. No. 5,389,657); injections of human growth hormone, (hGH) in daily doses (U.S. Pat. No. 5,250,514); or injections of testosterone analogs (U.S. Pat. No. 5,596,004).
There have also been some alternative treatments for male infertility reported. An infusion of lemongrass was reported to increase fertility in rats (Lemongrass infusions increase fertility in rats. Souza Formigoni 1986 J. Ethanopharmacol 17:65-74) and a water extract of the Chinese herb
Astragalus membranaceozis
was found to stimulate human sperm motility (
Astragalits membranaceous
stimulates human sperm motility in vitro. Hong C. Y. et al. 1992 Am. J. Chin. Med. 20:289-294).
The use of radish leaves as a medicine is well-known in the prior art. There are a number of patent documents and non-patent documents which teach the use of radish leaves to treat various ailments. Indeed it was generally known that radishes and radish leaves had a beneficial effect on health in humans. For example, U.S. Pat. No. 4,059,695 describes a type of tea that has radish leaves as one of its ingredients which acts as a general tonic for humans. As well, U.S. Pat. No. 5,498,412 describes a fermented mixture of various things including radish leaves which act as a natural antioxidant. As well, in the popular literature, a publication from 1982 describes the use of black radish in medicine (Slutomski, et al. “Black radish as a source of various phyto pharmaceuticals”) (1982). Another paper describes the inhibition of mutagenicity through use of radish extract (Badrid, S. A. (1994) Cancer Letters 84:1-5). In addition, in the Encyclopedia of Herbal Medicine, radish is listed as having various health keeping properties.
U.S. Pat. No. 5,736,144 to Gideon, S., entitled “Method of Producing a Medicinal Tea For Treating Infertility in Males and For Treating Prostatitis” (filed Dec. 4, 1995 and issued Apr. 7, 1998) relates to methods for treating infertility in males and for treating prostatitis. The invention relates to a natural medicine for treating infertility in males who suffer from germinal epithelium failure and for treating prostatitis in males. In brief, the invention produces a medicinal tea from the stems and leaves of the radish plant and the preferred version of this is the species raphanus sativus. The claims are to a method of treating clinically diagnosed infertility in a mammalian male, and comprise boiling the leafy portion of radish plants of the species raphanus sativus in water for a period of time sufficient to brew a tea and having said male ingest the tea to restore fertility. The invention claimed is also a method of treating diagnosed infertility by pressing the leafy portions of radish plants to produce an extract and having the male so diagnosed ingest the extract in an amount sufficient to restore fertility. Also claimed is a method for treating microbial infections or inflamation in sexual organs of a mammalian male, comprising pressing the leafy portions of radish plants to produce an extract and having the male ingest this extract in an amount sufficient to treat the microbial infection.
However, there is no teaching in this specification of the basis for activity of the tea which is derived from the radish leaf and stem portions, nor whether such tea has any effect in any animal other than humans.
Consequently, while a variety of hormonal and other treatments have been proposed for lack of fertility in males, none have been entirely successful, and there remains a need for identifying improved and/or alternative therapies for enhancing fertility. In particular, improved methods and compositions should be effective and efficiently delivered, have minimum side effects and optionally be compatible with other hormonal treatments. The instant invention addresses this need.
SUMMARY OF THE INVENTION
The present inventors have determined that an effective amount of a composition comprising spermidine and spermine is useful in enhancing the fertility and/or libido of a male mammal. In one embodiment the composition further comprises selenium. The inventors have also developed a method of enhancing fertility of a male mammal comprising administering to the male an effective amount of a composition of the invention.
Accordingly, in one embodiment the present invention provides a composition for use in enhancing the fertility and libido of a male mammal, the composition comprising spermine and spermidine in an amount effective to enhance fertility and libido.
According to another embodiment there is provided a composition for use in enhancing the fertility and libido of a male mammal, the composition comprising spermine, spermidine, and selenium in an amount effective to enhance fertility and libido.
According to another aspect of the present invention there is provided a method of enhancing fertility and increasing libido in a male mammal. According to one embodiment there is provided a method of enhancing fertility and libido of a male mammal comprising administering to the male an effective amount of a composition comprising spermine and spermidine to enhance fertility and libido.
According to another embodiment there is provided a method of enhancing libido of a male mammal comprising administering to the male and effective amount of a composition comprising spermine, spermidine and selenium to enhance libido. According to either embodiment it is prefered that the composition is administered at least once daily.
In an embodiment of the invention according to either the method or composition where the recipient mammal is equine, a prefered composition of spermine, spermidine and selenium is about 25 mg of spernine, about 25 mg of spermidine, and about 1 mg/12 g of a composition where the 1 mg od selenium. Where spermine and spermindine are used in an equine in the absence of selenium, the spermine and spermidine are provided in the amounts of about 25 mg of spermine, about 25 mg of spermidine.
According to prefered embodiments of both the method and the composition the mammal is selected from the group of mammals consisting of equine, porcine, bovine, feline, canine, camel, sheep and human, preferably equine.
With respect to components of the composition for the composition and for the method the spermidine, spermine or selenium may be derived from green plant materials, alternatively the spermidine, spermine or selenium may be synthetically derived.
Where the the source of selenium, spermine and spermidine is from green plants, such plants are preferably selected from the group consisting of radish leaves, corn, oat, and cucumber.
In another aspect of the present invention, the inventors have also determined that a tea prepared from radish leaves when administered to horses, provides an increase i
Bendera Richard J.
Wilson Leanna S.
Licata & Tyrrell P.C.
Patten Patricia
Weber Jon P.
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