Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from leguminosae
Reexamination Certificate
2002-05-30
2003-08-26
Tate, Christopher R. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
Containing or obtained from leguminosae
C424S725000
Reexamination Certificate
active
06610331
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates generally to a fertility kit used to enhance the natural fertility potential of both the male and female partner. It utilizes naturally occurring vitamins, minerals, herbs, and saccharides to assist with the normal ovulatory cycle in the female, improve the physicochemical properties of the cervical mucus, and improve the production of sperm in men along with improving the quality of the ejaculatory fluid derived from the prostate gland and seminal vesicles.
DISCUSSION OF THE RELATED ART
Approximately 15 % of all married couples experience some form of infertility. Primary infertility occurs in a couple in which a child has not been successfully conceived for a period of greater than one year while performing intercourse during an appropriate schedule. Secondary infertility occurs in a couple which has previously successfully conceived and who has failed to subsequently conceive. Approximately 40 % of all infertility problems are associated with a male factor, 40 % are associated with a female factor, and the remaining 20 % occur in couples when either both partners have an identifiable infertility cause or there is no identifiable reason in either partner that explains their infertility.
Male factor infertility may be the result of complete lack of sperm production, azoospermia, which may be the result of primary testicular failure or secondary testicular failure resulting from a previous disease such as the mumps or secondary to chemotherapy administration. Other causes include obstruction of the vas deferen or ejaculatory ducts. Greatly diminished sperm production, oligospermia, may be the result of similar problems or secondary to spermatogenic problems at the level of the testicles.
The ejaculatory fluid may be greatly diminished in patients with congenital absence of the seminal vesicles or prostate. Spinal cord lesions can also lead to retrograde ejaculation as can various surgical procedures. This results in an overall diminishment in the ejaculatory volume and the number of sperm expelled into the vaginal vault at the time of intercourse. The number, morphology, and motility of the sperm can also be greatly affected by environmental exposures such as that which occurs with cigarette smoking, alcohol intake, excessive heat exposure, and repetitive low-grade trauma to the testicles. Similar findings are seen in subfertile men with varicoceles. Super oxide free radicals can accumulate within the sperm cell, which can then cause degredation of the cellular membrane and nuclear material. Sperm injured by these intracellular oxidative radicals have a greatly reduced fertility potential.
In women, infertility problems are more difficult to detect. Primary infertility may result from bilateral ovarian agenesis, polycystic ovarian disease, congenital chromosomal abnormalities, congenital agenesis of the uterus and vaginal vault, etc. Secondary infertility may result from pelvic inflammatory disease, endometriosis, previous surgery, chemotherapy, etc. Anovulation has also been associated with an increased lean body mass ratio as seen in anorectic females and females partaking in strenuous activities/exercise. Conversely, significantly obese women are also found to be anovulatory. Intracellular oxidative free radicals also decrease the fertility potential of the egg.
Modern methods for infertility evaluation are found only in the clinical setting, typically within a medical practice. There are few books that are readily available to the public regarding information on fertility. Ovulation predictors, which are available over the counter, assess only one aspect of the fertility process and in no way enhance the natural process. To date, there is no readily available product that addresses steps which can be taken to enhance natural fertility without an exhaustive and expensive medical evaluation and treatment plan.
The current procedure in a fertility clinic includes evaluation of both the male and female partner. The male partner is evaluated with an initial sperm analysis which, if abnormal, is collected and analyzed on two additional occasions. At the same time, hormonal parameters associated with natural fertility are assessed. If the male is found to have abnormal seminal parameters with normal hormonal production, an investigation into his reproductive organs including an ultrasound of his testicles along with a prostate examination and possible ultrasound of this organ then ensue. If a varicocele is identified, this is surgically corrected. If this is not present and no obstruction is appreciated, a biopsy of the testicle is then performed. Depending upon the results of the biopsy, sperm may need to be harvested from an intratesticular site versus extratesticular sites such as the epididymis or vas deferens. This sperm would then be artificially introduced into a surgically acquired egg from the female utilizing either intracytoplasmic sperm injection versus in vitro fertilization with subsequent intrauterine or fallopian tube embryo transplantation at a later date.
If no male factor is found, the female proceeds with hormonal evaluation. If this appears normal, a transvaginal ultrasound is obtained to assess the perivaginal structures such as the uterus, fallopian tubes, and ovaries. Evidence for obstruction, endometriosis, pelvic inflammatory disease, etc., is sought. If the exam is unremarkable, a hysterosalpingogram is performed by a radiology specialist. This assesses for obstruction of the oviducts. If this is unremarkable, the female commonly undergoes a laparoscopic surgical procedure to assess for any scarring of the fimbriae of the oviduct which may preclude capture of the ruptured ovarian follicle. Any adhesions and scars are removed at that time. A post-coital test may have also been performed that assess the viability of sperm on the uterine cervix 6-12 hours following intercourse. If these factors all remain normal, the patient is then provided with an antiestrogen regimen typically consisting of clomiphene citrate and human chorionic gonadotropin which induces multiple follicles to enlarge on the ovaries. Another medication is then provided to stimulate ovulation and a washed sperm specimen is then injected into the uterus. If this fails to be successful, multiple follicles can be induced to ovulate once again. These are then surgically retrieved and cultured in-vitro with a sperm sample. Viable conceptions are then evaluated a few days later. Multiple embryos are then inserted in hopes that at least one will remain viable and develop to term. It is not unusual for the cost of these procedures to exceed well over $20,000.
Thus, there is a need for a convenient, inexpensive fertility kit that will enhance a couple's natural fertility processes. There is also a need for a kit that will provide a couple with all the material required and allow them to complete this in the privacy of their own home. There is also a need for educational material to be included within this kit so that a couple can be ensured of maximizing the natural fertility factors to their desired end.
SUMMARY OF THE PRESENT INVENTION
Accordingly, the present invention provides a method and a kit which provide a couple with the ability to maximize their fertility potential by limiting any negative environmental factors or lifestyle factors and by enhancing the natural fertility factors which influence their fertility. Moreover, all materials are provided in a conveniently utilized product which is biologically appropriate, safe to use, inexpensive, and expedient in manner and is provided in an all inclusive fertility kit.
The invention as described above, does not directly create a successful conception. It does not proceed with any artificial measures so as to induce prolonged contact of sperm with the cervical os, as which is done with other conception products, nor does it artificially induce sperm into the female reproductive tract. The fertility kit, as described, does not induce ovulation nor does it induce the maturation of
Sweazy Jill A.
Sweazy Scott M.
Patten Patricia
Smith Moore LLP
Tate Christopher R.
LandOfFree
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