Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving antigen-antibody binding – specific binding protein...
Reexamination Certificate
2003-02-10
2010-02-02
Allen, Marianne P (Department: 1647)
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving antigen-antibody binding, specific binding protein...
C530S391100, C530S391300
Reexamination Certificate
active
07655410
ABSTRACT:
The present invention provides a method for predicting the likely timing of the onset of menopause for a perimenopausal female subject by determining the amount of hLHβcf in a sample from the subject comprising the steps of: (a) contacting a sample from the subject with an antibody which specifically binds to hLHβcf without substantially cross-reacting with hLH, hLHβ or hLHβcf, under conditions permitting formation of a complex between the antibody and hLHβcf; (b) measuring the amount of complex formed, so as to thereby determine the amount of hLHβcf in the sample; and (c) comprising the amount of hLHβcf in the subject's sample determined in step (b) with either (i) the amount determined for known postmenopausal female subject or (ii) the amount determined for a sample from a known premenopausal female subject, wherein an amount of hLHβcf in the sample similar to the amount of hLHβcf in the known postmenopausal sample indicates temporal proximity to the onset of menopause, and an amount of hLHβcf in the sample similar to the amount of hLHβcf in the known premenopausal sample indicates temporal distance from the onset of menopause for the subject. AS described herein amount is both concentration and pattern of measurement of concentrations in one or more consecutive urine specimens.
REFERENCES:
patent: 4503143 (1985-03-01), Gerber et al.
patent: 4851356 (1989-07-01), Canfield et al.
patent: 5156977 (1992-10-01), Hirth et al.
patent: 5976876 (1999-11-01), Canfield et al.
patent: 6521416 (2003-02-01), Birken et al.
patent: 7034124 (2006-04-01), Canfield et al.
patent: 2003/0059842 (2003-03-01), Birken et al.
Blithe, D.L. et al. 1988. Purification of beta-core fragment from pregnancy urine and demonstration that its carbohydrate moieties differ from those of native human chorionic gonadotropin-beta. Endocrinology 122:173-180.
Burger, H.G. 1994. Diagnostic role of follicle-stimulating hormone (FSH) measurements during the menopausal transition-an analysis of FSH, oestradiol and inhibin [Review]. Eur. J. Endocrinology 130:38-42.
Burger, H.G. et al. 1995. Aspects of current and future inhibin research. [Review]. Reprod. Fertil. Dev. 7:997-1002.
Burger, H.G. 1996. The endocrinology of the menopause. [Review]. Maturitas 23:129-136.
Cole, L.A. et al. 1988. Urinary human chorionic gonadotropin free beta-subunit and beta-core fragment: a new marker of gynecological cancer. Cancer Res. 48:1356-1360.
Cole, L.A. et al. 1990. Urinary gonadotopin fragment, a new tumor marker. II. Differentiating a benign from a malignant pelvic mass. Gynecol. Oncol. 36:391-394.
Cole, L.A. et al. 1988. Urinary gonadotropin fragments (UGF) in cancers in the female reproductive system. I. Sensitivity and specificity, comparison with other markers. Gynecol. Oncol. 31:82-90.
Hee, J. et al. 1993. Perimenopausal patterns of gonadotropins, immunoreactive inhibin, oestradiol, and progesterone. Maturitas 18:9-20.
Iles, R.K. et al. 1992. Immunoreactive beta-core-like material in normal post-menopausal urine: human chorionic gonadotrophin or LH origin? Evidence for the existence of LH core. J. Endocrinol. 133:459-466.
Kato, Y. and G.D. Braunstein, 1988. Beta-core fragment is a major form of immunoreactive urinary chorionic gonadotropin in human pregnancy. J. Clin. Endocrinol. Metab. 66: 1197-1201.
Kovalevskaya, G. et al. 1995. HLH beta core fragment immunoreactivity in the urine of ovulating women: A sensitive and specific immunometric assay for its detection. Endocrine 3: 881-887.
Krichevsky, A. et al. 1991. Development and characterization of a new, highly specific antibody to the human chorionic gonadotropin-beta fragment. Endocrinology 128: 1255-1264.
Krichevsky, A. et al. 1994. The development of a panel of monoclonal antibodies to human luteinizing hormone and its application to immunological mapping and two-site assays. Endocrine 2: 511-520.
Lee, C.L. et al. 1991. The purification and development of a radioimmunoassay for beta-core fragment of human chorionic gonadotrophin in urine: application as a marker of gynaecological cancer in premenopausal and postmenopausal women. J. Endocrinol. 130: 481-489.
Neven, P. et al. 1993. Urinary chorionic gonadotropin subunits and beta-core in nonpregnant women: A study of benign and malignant gynecologic disorders. Cancer 71: 4124-4130.
Neven, P. et al. 1993. Substantial urinary concentrations of material resembling beta-core fragment of chorionic gonadotropin beta-subunit in mid-menstrual cycle. Clin. Chem. 39: 1857-1860.
O'Connor, J.F. et al. 1994. Recent advances in the chemistry and immunochemistry of human chorionic gonadotropin: impact on clinical measurements. [Review]. Endocr. Rev. 15: 650-683.
O'Connor, J.F. et al. 1998. The expression of the urinary forms of human luteinizing hormone beta fragment in various populations as assessed by a specific immunoradiometric assay. Human Reproduction 13: 826-83.
O'Connor, J.F. et al. 1988. Development of highly sensitive immunoassays to measure human chorionic gonadotropin, its beta-subunit, and beta core fragment in the urine: application to malignancies. Cancer Res. 48: 1361-1366.
Santoro, N. et al. 1996. Characterization of reproductive hormonal dynamics in the perimenopause. J. Clin. Endo. Metab. 81: 1495-1501.
Schroeder, H.R. and C.M. Halter, 1983. Specificity of human beta-choriogonadotropin assays for the hormone and for an immunoreactive fragment present in urine during normal pregnancy. Clinical Chemistry 29: 667-671.
Birken Steven
Kovalevskaya Galina I.
Maydelman Yacov
O'Connor John F.
Allen Marianne P
Cooper & Dunham LLP
DeBerry Regina M
The Trustees of Carolina University in the City of New York
White John P.
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