Diagnostic kit for predicting pregnancy outcome

Chemistry: analytical and immunological testing – Pregnancy or ovulation

Reexamination Certificate

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C422S067000, C435S007100, C435S007500, C435S007920, C435S007940, C436S501000, C436S518000, C436S524000, C436S528000, C436S065000, C436S547000, C436S548000, C530S387500, C530S388240, C530S389200

Reexamination Certificate

active

07399636

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 is 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.

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Kardana, A. et al. (1991) “The heterogeneity of human chorionic gonadotropin (hCG). I. Characterization of peptide heterogeneity in 13 individual preparations of hCG,” Endocrinology 129(3):1541-50 (Exhibit 9).
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Cole, L.A., Cermik, D. and Bahado-Singh, R. (1997) “Oligosaccharide variants of hCG-related molecules: potential screening markers for Down syndrome,”Prenat. Diagn. 17:1188-1190 ( Exhibit 9).
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Birken, S., Krichevsky, A., O'Connor, J., Schlatterer, J., Cole, L., Kardana, A. and Canfield, R. (1999) “Development and characterization of antibodies to a nicked and hyperglycosylated form of hCG from a choriocarcinoma patient,”Endocrinology10(2):137-144.
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Cole, L., Kardana, A., Andrade-Gordon, P., Gawinowicz, M., Morris, J., Bergert, E., O'Connor, J. and Birken, S. (199

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