Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving antigen-antibody binding – specific binding protein...
Reexamination Certificate
2011-08-09
2011-08-09
Cook, Lisa (Department: 1641)
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving antigen-antibody binding, specific binding protein...
C435S002000, C435S007100, C436S501000, C436S518000, C436S522000, C422S050000, C530S300000, C530S350000, C424S130100
Reexamination Certificate
active
07993858
ABSTRACT:
The present invention provides a method of predicting pregnancy outcome in a subject by determining the amount of an early pregnancy associated molecular isoform of hCG in a sample. The present invention further provides a method for determining the amount of early pregnancy associated molecular isoforms of human chorionic gonadotropin (hCG) in a sample. The present invention also provides a diagnostic kit for determining the amount of early pregnancy associated hCG in a sample. The present invention additionally provides an antibody which specifically binds to an early pregnancy associated molecular isoform of human chorionic gonadotropin. Finally, the present invention provides methods for detecting trophoblast or non-trophoblast malignancy in a sample.
REFERENCES:
patent: 4444879 (1984-04-01), Foster et al.
patent: 4514505 (1985-04-01), Canfield et al.
patent: 5260421 (1993-11-01), Chappel et al.
patent: 6133048 (2000-10-01), Penfold et al.
patent: 6339143 (2002-01-01), Krichevsky et al.
patent: 6429018 (2002-08-01), Cole et al.
patent: 6500627 (2002-12-01), O'Connor et al.
patent: 6627457 (2003-09-01), Pandian et al.
patent: 6927034 (2005-08-01), O'Connor et al.
patent: 7198954 (2007-04-01), O'Connor et al.
patent: 7285391 (2007-10-01), O'Connor et al.
patent: 7399636 (2008-07-01), O'Connor et al.
patent: 04300896 (1992-10-01), None
patent: WO 88/04779 (1988-06-01), None
patent: WO 92/07272 (1992-04-01), None
patent: WO 99/41584 (1999-08-01), None
patent: WO 00/70094 (2000-11-01), None
U.S. Appl. No. 09/918,297, filed Jul. 30, 2001, Pandian, M.R. and Yu J.Y.
Bogart et al., (1989) AHuman Chorionic Gonadotropin Levels in Pregnancies with Aneuploid Fetuses@,Prenat.Diagn.9: 379-384.
Bogart et al., (1987) AAbnormal Maternal Serum Chorionic Gonadotropin Levels in Pregnancies with Fetal Chromosome Abnormalities@, Prenat.Diagn. 7: 623-630.
Cole et al., (1997) AOligosaccharide Variants of hCG-related Molecules: Potential Screening Markers for Down Syndrome@,Prenat.Diagn.17: 1188-1190.
Cole et al., (1998) AHyperglycosylated hCG, A Potential Alternative To hCG in Down Syndrome Screening@,Prenat.Diagn.18: 926-933.
Cole et al., (1997) A Urine β-Core Fragment, a Potential Screening Test for Ectopic Pregnancy and Spontaneous Abortion@,Fetal.Diagn.Ther.12: 336-339.
Forest et al., (1995) AScreening for Down Syndrome During the First and Second Trimesters: Impact of Risk Estimation Parameters@,Clin.Biochem.28: 443-449.
Kovalevskaya et al., (1999) AEarly Pregnancy Human Chorionic Gonadotropin (hCG) Isoforms Measured By An Immunometric Assay for Choriocarcinoma-like hCG@,J.Endocrinol.161: 99-106.
Spencer et al., (1996) AUrine Free beta-hCG and Beta Core in Pregnancies Affected by Down=s Syndrome@,Prenat.Diagn.16: 605-613.
Spencer et al., (1993) AStability of Intact Chorionic Gonadotropin (hCG) in Serum, Liquid Whole Blood, and Dried Whole-Blood Filter-Paper Spots: Impact on Screening for Down Syndrome by Measurement of Free β-hCG Subunit@,Clin.Chem.39: 1064-1068.
Spencer et al., (1997) ABiochemical Markers Markers of Trisomy 21 in Amniotic Fluid@,Prenat.Diagn.17: 31-37.
Valerio et al., (1996) AMaternal Serum Screening of Fetal Chromosomal Abnormalities by AFP, UE3, hCG and free-βhCG@,Minerva.Ginecol.48: 169-173.
Wald et al., (1994) AFour-Marker Serum Screening For Down=s Syndrome@,Prenat.Diagn.14: 707-716.
Wald et al., (1994) AFirst Trimester Biochemical Screening for Down=s Syndrome@,Ann.Med.26: 23-29.
Zimmermann et al., (1996) AAge-Independent Indices in Second-Trimester Serum Screening for Down=s Syndrome Are Useless@, Prenat.Diagn. 16: 79-82.
Birken et al., (1993) ASeparation of Nicked Human Chorionic Gonadotropin (hCG), Intact hCG, and hCG Beta Fragment From Standard Reference Preparations and Raw Urine Samples@,Endocrinology133:1390-1397.
Birken et al., (1996) AMetabolism of hCG and hLH to Multiple Urinary Forms@,Mol. Cell Endocrinol.125: 121-131.
Birken et al., (1996) AIsolation and Characterization of Human Pituitary Chorionic Gonadotropin@,Endocrinology137: 1402-1411.
Cole et al., (1993) AThe Deactivation of hCG by Nicking and Dissociation@,J.Clin.Endocrinol.Metab.76: 704-710.
Cole et al., (1985) AThe Structures of the Serine-linked Sugar Chains on Human Chorionic Gonadotropin@,Biochem.Biophys.Res.Commun.126: 333-339.
Ellish et al., (1996) AA Prospective Study of Early Pregnancy Loss@,Hum.Reprod.11: 406-412.
Hoermann et al., (1994) AImmunological Recognition and Clinical Significance of Nicked Human Chorionic Gonadotropin in Testicular Cancer@,Clin.Chem.40: 2306-2312.
Kovalevskaya et al., (1995) AHLH Beta Core Fragment Immunoreactivity in the Urine of Ovulating Women: A Sensitive and Specific Immunometric Assay for its Detection@, Endocrine 3: 881-887.
O=Connor et al., (1994) ARecent Advances in the Chemistry and Immunochemistry of Human Chorionic Gonadotropin: Impact on Clinical Measurements@,Endocr.Rev.15: 650-683.
O=Connor et al., (1998) ADifferential Urinary Gonadotropin Profiles in Early Pregnancy and Early Pregnancy Loss@,Prenat.Diagn.18: 1232-1240.
O=Connor et al., (1988) ADevelopment 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.
Wilcox et al., (1988) AIncidence of Early Loss of Pregnancy@,N.Engl.J.Med.319: 189-194.
Zinaman et al., (1996) AEstimates of Human Fertility and Pregnancy Loss@, Fertil.Steril. 65: 503-509.
Acevedo et al., (1992) AExpression of Membrane-associated Human Chorionic Gonadotropin, Its Subunits, and Fragments by Cultured Human Cancer Cells@, Cancer 69(7): 1829-1842.
Berger et al., (1993) AVariants of Human Chorionic Gonadotropin from Pregnant Women and Tumor Patients Recognized by Monoclonal Antibodies@, J. Clin. Endocrinol. and Metabolism 77(2): 347-351.
Birken et al., (1999) ADevelopment and Characterization of Antibodies to a Nicked and Hyperglycosylated Form of hCG from a Choriocarcinoma Patient@, Endocrinology 10(2): 137-144.
Cole et al., (1991) AThe Heterogeneity of Human Chorionic Gonadotropin (hCG). III. The Occurrence and Biological and Immunological Activities of Nicked hCG@, Endocrinology 129(3): 1559-1567.
Hoermann et al., (1993) AMolecular Heterogeneity of Human Chorionic Gonadotropin in Serum and Urine from Patients with Trophoblastic Tumors@, Clinical Investigation 71: 953-960.
Kovalevskaya et al., (1999) AEvaluation of Nicked Human Chorionic Gonadotropin Content in Clinical Specimens by a Specific Immunometric Assay@, Clinical Chemistry 45(1):68-77.
Birken et al., (1993) ASeparation of Nicked Human Chorionic Gonadotropin (hCG), Intact hCG, and hCGβ Fragment from Standard Reference Preparations and Raw Urine Samples@, Endocrinology 133(3): 1390-1397.
Ellish et al., (1996) AA Prospective Study of Early Pregnancy Loss@, Human Reproduction 11(2): 407-408.
Hoermann et al., (1994) AImmunological Recognition and Clinical Significance of Nicked Human Chorionic Gonadotropin in Testicular Cancer@ Clinical Chemistry 40(12): 2306-2312.
Knight, (1989) AThe Carbohydrate Frontier@, Biotechnology 7(1): 35 and 39-40.
Cole, L.A. (1998) “hCG, its free subunits and its metabolites. Roles in pregnancy and trophoblastic disease,” J. Reproductive Med. 43(1):3-10.
Huang, S., et al. (1998) “A chromatofocusing study of human chorionic gonadotropin in biological fluids in normal pregnancy, pre-eclampsia and choriocarcinoma,” J. Formos Med. Assoc. 87:1036-44.
Kovalevskaya, G., et al. (2002) “Differential expression of human chorionic gonadotropin (hCG) glycosylation isoforms in failing and continuing pregnancies: preliminary characterization of the hyperglycosylated hCG epitope,” J. Endocrinology 172:497-506.
Rau, B., et al. (1995) “Significance of beta-hCG in the serum as a tumor marker for gastric cancer,” Langenbecks Arch. Cher. 380:359-64.
Aoki, D. et al. (2005) Diagnostic significance of tumor markers for gynecologic malignancies Gan to Kagaku Ryoho, 32(3):411-6 (in the Japanese language).
Cole, L (1997) Immunoassay of Human Chorionic Gondotropin
Birken Steven
Kovalevskaya Galina
O'Connor John
Cook Lisa
Cooper & Dunham LLP
The Trustees of Columbia University in the City of New York
White John P.
LandOfFree
Methods for predicting pregnancy outcome in a subject by hCG... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Methods for predicting pregnancy outcome in a subject by hCG..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Methods for predicting pregnancy outcome in a subject by hCG... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2642230