Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical
Reexamination Certificate
1999-07-01
2001-01-16
Pak, John (Department: 1616)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Food or edible as carrier for pharmaceutical
C424S195110, C424S451000, C424S464000, C424S474000, C424S682000, C426S072000, C514S345000, C514S904000, C514S905000, C514S783000
Reexamination Certificate
active
06174542
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to dietary and herbal supplements and snack foods, and more particularly, to chocolate containing dietary, vitamin, mineral and herbal supplements, and food products containing the same, useful for treating, preventing, alleviating or managing symptoms associated with premenstrual syndrome (PMS) in women.
2. Description of Related Art
The term premenstrual syndrome, or PMS, is generally used to describe a group of physical and mental symptoms which occur cyclically beginning about seven to fourteen days prior to menses. Menstruation occurs in women from the age of about twelve to thirteen to, on average, until about forty seven years of age. It occurs at more or less regular intervals except during pregnancy and lactation. The normal menstrual cycle averages about twenty-eight days with some variation based upon the woman's genetic makeup, age, physical and emotional well being, as well as other factors. The duration of menstrual flow is variable but usually is between three and seven days. The symptoms of PMS are often so severe and widespread that the American Psychiatric Association has formally identified the diagnostic criteria for PMS in
Diagnostic and Statistical Manual of Mental Disorders.
The specific etiology of PMS remains unknown, although many theories have been proposed. These theories include, but are not limited to: hormonal imbalances, hormonal deficiencies, vitamin deficiencies, disturbances of autonomic nervous system, salt and water imbalances, altered endogenous opiates such as endorphins and psychosomatic dysfunction, just to name a few. However, up to now, investigative studies of etiology have been inconclusive and sometimes conflicting. Most likely, PMS is multifactorial and probably also involves changes in neurohormones and neurotransmitters, which are difficult to observe, document and isolate in vivo. See, M. Ferin, R. Jewelewicz and M. Warren,
The Menstrual Cycle: Physiology, Reproductive Disorders and Infertility
, pp. 198-204 (1993).
Symptoms of PMS are varied and can range from mild to incapacitating. As many as seventy to ninety percent of all women have recurrent premenstrual syndrome, and as many as twenty to forty percent of these women suffer some degree of temporary physical and/or mental incapacitation. Some examples of mental symptoms a woman suffering from PMS may exhibit include difficulty in concentration, fatigue, change in appetite, irritability and depression. Some examples of physical symptoms a woman suffering from PMS may exhibit are increase or decrease in sleep, joint pain, cramps, bloating, edema, acne, constipation and breast tenderness.
It is theorized that some PMS manifestations such as mood and behavior disorders are induced by a drop in the level of biogenic amines in the central nervous system. Lower brain neurotransmitters such as serotonin have been implicated in the etiology of PMS. See Taylor, D. L. et al., Neuropsychobiology, 12:16 (1984). This can perhaps explain another symptom that many PMS suffers seem to exhibit which is the craving of chocolate or foods containing chocolate. Chocolate is a food that contains, among many other things, fat and sugar. Evidence suggests that a woman's cravings for chocolate lie in the body's biochemical need to increase or boost levels of endorphins and serotonin in the brain; chemicals whose levels are increased in the brain upon ingestion of chocolate. Chocolate also contains other agents such as phenylethylamine, theobromine and magnesium that appear to ameliorate some symptoms of PMS.
The physical, neurological and psychological symptoms of premenstrual syndrome are a major cause of suffering and discomfort to women, and cause substantial loss of time and efficiency in the workplace and can be a major disruption in a women's personal life. A number of prescription and over the counter pharmaceutical preparations, as well as dietary supplements are currently available which are designed to provide relief for one of more of the symptoms of PMS. However, the vast majority of these products include drugs such as antihistamines, nonsteroidal anti-inflammatories and diuretics that fail to provide adequate relief from the symptoms of PMS, including chocolate cravings, and usually have detrimental side effects. Most of the currently available PMS products fail to include the proper combination of herbs, vitamins and minerals delivered in a convenient, appetizing, appealing and ready to eat dietary food product. Examples of various PMS treatments somewhat representative of the prior art follow.
U.S. Pat. No. 5,612,061 issued on Mar. 18, 1997 to Rabkin discloses a composition and a method for the treatment of PMS containing calcium, magnesium, an analgesic and a diuretic.
U.S. Pat. No. 5,569,459 issued on Oct. 29, 1996 to Shlyankevich discloses pharmaceutical compositions for the treatment of PMS consisting of vitamins, minerals and herbal extracts capable of controlling the stimulation of estrogen production in women.
U.S. Pat. No. 5,498,631 issued on Mar. 12, 1996 to Gorbach et al. discloses a method for the treatment of PMS by administering a therapeutic dietary product comprising an effective amount of flavonoids, which are constituents of soy beans and other plants, and are believed to exert an estrogenic effect on the human body.
U.S. Pat. No. 5,654,011 issued on Aug. 5, 1997 to Jackson et al. discloses a method for treating PMS by administering dietary supplements comprising mostly vitamins and minerals.
U.S. Pat. No. 5,707,630 issued on Jan. 13, 1998 to Morrow discloses a tablet of an herbal compound for treating symptoms associated with PMS.
U.S. Pat. No. 5,760,014 issued on Jun. 2, 1998 and U.S. Pat. No. 5,612,320 issued on Mar. 18, 1997, both to Wurtman et al., disclose methods of alleviating or managing carbohydrate craving associated with PMS by administering a blend of rapidly digestible carbohydrates.
The prior art recognizes the multitude of symptoms, as well as the range in the degree of severity of the symptoms, associated with PMS, as attested by the numerous treatments available to woman suffering from PMS. However, none of the above inventions and patents, taken either singly or in combination, are seen to describe the instant invention as claimed; that is, a convenient, appetizing and ready to eat snack food capable of satisfying a woman's craving for chocolate, while delivering an effective amount of herbs, vitamins and minerals useful in treating, preventing, alleviating or managing symptoms of PMS.
SUMMARY OF THE INVENTION
The objects of this invention are achieved by dietary herbal, vitamin and mineral containing snack food products for treating, preventing, alleviating or managing symptoms associated with premenstrual syndrome (PMS) in woman, comprising an effective amount of the following essential ingredients: kava kava root or St. John's wort; cayenne, ginger and ginseng; chickweed or buchu or pyridoxine (vitamin B
6
), and wild yam root. In a preferred embodiment, the snack food products will also contain chocolate, powder chocolate or a combination of ingredients that make up chocolate. Examples of snack food products incorporating an effective amount of these essential ingredients are liquid beverages such as shakes, juices or cappucinos; solid snack foods such as granola or chocolate bars, chocolate cookie, chocolate brownie, chocolate cake, hard or soft candies, or gum; or semi-solid snack foods such as ice cream or yogurt, just to name a few.
Accordingly, it is a principal object of the invention to provide a dietary snack food product that satisfies a PMS sufferer's craving for foods high in fat and sugar, such as chocolate, while delivering herbs, vitamins and minerals that can help alleviate, treat, prevent and manage symptoms associated with PMS.
It is another object of the invention to provide a dietary snack food product capable of alleviating, treating, preventing or managing symptoms associated with PMS that i
Greene Jeri J.
Hinton Deborah A.
Litman Richard C.
Pak John
PMS Mood Food, Inc.
Pryor Alton
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