Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from zingiberaceae
Reexamination Certificate
2000-02-25
2001-06-05
Lilling, Herbert J. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
Containing or obtained from zingiberaceae
C424S451000, C424S452000, C424S455000, C424S464000, C424S465000, C424S489000, C424S773000, C424S777000, C514S023000, C514S027000, C514S627000, C514S825000, C514S827000, C514S886000
Reexamination Certificate
active
06242012
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates to herbal compositions. More particularly, this invention relates to an herbal composition which can promote pre- and postmenopausal hormonal balance in women. The present invention further relates to methods of using such composition to promote hormonal balance.
From the commencement of menstruation until the termination of menopause, the female body can experience wide fluctuations in baseline hormonal levels. When such fluctuations cause an imbalance in the hormonal composition, certain chemical reactions occur which cause what are commonly referred to as PMS and/or menopausal symptoms. These symptoms include headaches, cramping, nausea, inflammation, increased agitation, anxiety, tension, restlessness, decreased digestive tract activity, depression, moodiness and severe mood swings.
Hormone Replacement Therapy (RWI) and conventional treatments for hormonal imbalance conditions like PMS in women are the subject of countless articles and controversy. Few would question that the treatment protocols are fraught with acute side effects and potential long term health concerns. A search for historically safe and effective hormonal health/balance programs with a basis in modern science is of great need for women today.
According to a growing body of research, the eicosanoid cascade plays a critical role in women's health and hormonal balance. An imbalance correlates not only with uncomfortable menstrual cycles, resulting in conditions like PMS, but also might relate to serious degenerative conditions like osteoporosis, heart disease and cancer. Historical and scientific research confirms that herbal alternatives exist which can safely bring more comfort and balance to a women's hormonal cycles.
Herbs which are known to be useful in alleviating symptoms associated with hormonal balance in women include, e.g., schizandra, ginger, black cohosh, and vitex extract.
Compounds in schizandra called schizandrins have been found to have comparable or stronger free radical scavenging capability than vitamins C and E. Reference is made, e.g., to
Cell Biol Int Rep
February 1990;14(2):99-109 Scavenging effect of schizandrins on activeoxygen radicals. Zhao B L, Li X J, Liu G T, Jia W J, Xin W J Institute of Biophysics, Academia Sinica, Beijing, China.; and
Free Radic Biol Med
1990;9(2):99-104 Scavenging effects on active oxygen radicals by schizandrins with different structures and configurations. Li X J, Zhao B L, Liu G T, Xin W J Institute of Biophysics, Academic Sinica, Beijing, China. Relief of oxidative stress is important in a number of health conditions associated with hormonal health.
Ginger contains at least one constituent which is active against 5-lipoxygenase. Reference is made, e.g., to
Chem Pharm Bull
(Tokyo) February 1992;40(2):387-91 Inhibition of prostaglandin and leukotriene biosynthesis by ginerols and diarylheptanoids. Kiuchi F, Iwakami S, Shibuya M, Hanaoka F, Sankawa U Faculty of Pharmaceutical Sciences, University of Tokyo, Japan;
Prostaglandins Leukot Med
October 1986;24(2-3);195-8 Inhibition of human neutrophil 5-lipoxygenase activity by gingerdione, shogaol, capsaicin and related pungent compounds. Flynn D L, Rafferty M F, Boctor A M;
Nippon Yakurigaku Zasshi
October 1986;88(4):263-9 [Pharmacological studies on ginger. IV. Effect of (6)-shogaol on the arachidonic cascade]. Suekawa M, Yuasa K, Isono M, Sone, H, Ikeya Y, Sakakibara I, Aburada M, Hosoya E;
Cancer Res
February 1991;51(3):813-9 Inhibitory effects of curcumin on in vitro lipoxygenase and cyclooxygenase activities in mouse epidermis. Huang M T, Lysz T, Ferraro T, Abidi T F, Laskin J D, Conney A H Department of Chemical Biology and Pharmacognosy, College of Pharmacy, Rutgers, State University of New Jersey, Piscataway, N.J. 0885-0789; and
Prostaglandins Leukot Med
June 1986;22(3):357-60 Inhibition of 5-hydroxy-eicosatetraenoic acid (5-HETE) formation in intact human neutrophils by naturally-occurring diarylheptanoids: inhibitory activities of curcuminoids and yakuchinones. Flynn D L, Rafferty M F, Boctor A M. Thus, ginger has been found to exhibit anti-inflammatory properties.
Ginger also exhibits anti-oxidant benefits.
Black cohosh has been found to be a safe, effective alternative to estrogen replacement therapy for those patients in whom estrogen replacement therapt is either refused or contraindicated. Reference is made, e.g., to
Womens Health
June 1998;7(5):525-9 A review of the effectiveness of
Cimicifuga racemosa
(black cohosh) for the symptoms of menopause. Leiberman S University of Bridgport, Conn., USA.; and
Adv Ther
January-February 1998;15(1):45-53 Therapeutic efficacy and safety of
Cimifuga racemosa
for gynecological disorders. Liske E Schaper & Brummer GmbH & Co. KG, International Sales Division, Salzgitter-Ringelheim, Germany.
Vitex extract is effective n treatment of PMS luteal phase defects due to latent hyperprolactinaemia. See, e.g.,
Arzneimittelforshung
July 1993;43(7):752-6 [Vitex agnus castus extract in the treatment of luteal phase defects due to latent hyperprolactinemia. Results of a randomized placebo-controlled double-blind study]. Milewicz A, Sworen H, Sienkiewicz K, Jedrzejak J, Teucher T, Schmitz H Abteilung fur Endokrinologie, Medizinizche Hocschule, Hamburg.
Other References which teach the use of herbs to relieve symptoms caused by female hormonal imbalances are, e.g., U.S. Pat. Nos. 5,569,459; 5,707,630; 5,891,440; 5,565,199; and 5,874,084.
Given the changing characteristics of the hormaonal imbalance during the menstrual cycle and/or menopause, as well as the variations in the specific hormonal inbalance from person to person, it would be advantageous to introduce a compound which adapts to meet the specific needs of each person, both over time and from person to person. Herbs have been found to meet such needs.
The human body is able to identify the chemical components in which it is deficient. An interesting and important feature of herbal interaction with the human body is the fact that the body will only absorb from an herbal compound those chemical components in which the body is deficient. Those chemical components of the herbal compound which are not needed simply pass through the body without undue stress placed on the body.
Thus, although it is known to use certain herbs to relieve symptoms associated with hormonal imbalance in women, the benefits associated with the use of herbs makes it continually desirable to provide alternative herbal compositions for providing such relief.
It is also continually desirable to provide a herbal composition which, in addition to relieving symptoms of hormonal imbalance, is also able to scavenge oxygen free radicals, thus providing antioxidant benefits.
Herbs which are known to possess antioxidant properties include, e.g., ginger and rosemary.
A further desirable characteristic of an herbal composition designed to promote hormonal balance is the ability to inhibit the enzyme 5-lipoxygenase. Recent scientific research has shown that estrogen may promote bone growth by inhibiting this enzyme. According to the USDA Phytochemical Database, ginger and rosemary extracts inhibit 5-lipoxygenase.
Accordingly, a primary object of this invention is to provide an herbal composition which is capable of relieving symptoms associated with pre- and postmenopausal hormonal imbalance.
A further object of this invention is to provide an herbal composition which, in addition to promoting hormonal balance in women, is also capable of providing antioxidant benefits.
Another object of this invention is to provide a hormonal balance promoting herbal composition which is capable of inhibiting the enzyme 5-lipoxygenase, thereby promoting normal bone growth and healthy sexual functioning.
Yet another object of this invention is to provide a hormone-balancing herbal composition which is capable of sustaining warmth and normal fluids for healthy sexual functioning.
A still further object of this invention is to provide an orally, topically or parenterally ad
Newmark Thomas
Schulick Paul
Lilling Herbert J.
Patton & Boggs LLP
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