Claims for Patent: 10,018,625

Summary for Patent: 10,018,625

Title:	Use of female mammal\'s urine for determination of fetal gender related characteristics
Abstract:	The present invention provides a method for determining the gender of a fetus by assaying the sex hormones, evaluating the overall reducing/oxidizing (redox) activity, and/or evaluating the radical scavenging capacity of the maternal urine or other body fluid. The method can be used to determine fetal gender at any time point during the entire pregnancy. The body fluid may be processed before assaying. Processing may involve aging the body fluid, or purification of various fractions. The methods of the present invention also provide for a means for pre-conception offspring gender planning by assaying the sex hormones, evaluating the overall reducing/oxidizing (redox) activity, and/or evaluating the radical scavenging capacity of the urine or other body fluid from a non-pregnant female. The sex hormone profiles, the overall redox activity, and/or the radical scavenging capacity of a urine sample correlates with the gender specific compatibility of the ovum being released during a particular menstrual cycle. Therefore, assaying aforementioned parameters from a non-pregnant female\'s urine will help a couple or an animal breeder have an offspring of a desired gender. The present invention also provides a method of conceiving a baby of a desired gender in a female by applying to the female a pharmaceutical formulation with a specific sex hormone composition.
Inventor(s):	Verma; Kuldeep C. (Livonia, MI)
Assignee:	Urobiologics LLC (Livonia, MI)
Application Number:	14/312,534
Patent Claims:	1. A method of determining the gender of an unborn child carried by a pregnant female or determining gender specific compatibility of an ovum released in a menstrual cycle of a non-pregnant female, the method comprising: obtaining a urine sample fluid from the pregnant female carrying the unborn child or the non-pregnant female; aging the urine sample at ambient temperature for at least about 2 days; passing the aged urine sample over a solid surface comprising antibodies specific to an estrogen, antibodies specific to testosterone, antibodies specific to progesterone, and antibodies specific to human chorionic gonadotropin beta subunit (hCG-beta); contacting the solid surface with at least one redox indicator, wherein the at least one redox indicator is selected from the group consisting of: sodium salicylate, methylene blue, a heteropoly acid or its salt, a chromogenic chemical, a fluorophore, a redox sensitive polymer, a free radical, and combinations thereof; detecting a net redox activity of the estrogen, testosterone, progesterone, and hCG-beta retained on the solid surface by the antibodies specific to the estrogen, the antibodies specific to testosterone, the antibodies specific to progesterone, and the antibodies specific to hCG-beta, wherein the net redox activity is detected by a change in a chemical property of the at least one redox indicator; comparing the net redox activity with a known net redox activity of at least one standard, wherein the at least one standard comprises a second pregnant female carrying a second unborn child of known gender or a second non-pregnant female carrying a second ovum of known gender specific compatibility; and determining the gender of the unborn child or the gender specific compatibility of the ovum released in the menstrual cycle of the non-pregnant female based on the comparison of the detected net redox activity to the known net redox activity of the at least one standard. 2. The method of claim 1, wherein the heteropoly acid is phospho-24-tungstic acid. 3. The method of claim 1, wherein the chromogenic chemical is selected from the group consisting of ferric tripyridyltriazine (Fe(III)-TPTZ) complex and potassium ferricyanide. 4. The method of claim 1, wherein the free radical is a hydroxyl radical. 5. The method of claim 1, wherein sodium salicylate or methylene blue is used as the at least one redox indicator. 6. The method of claim 1, wherein the net redox activity is measured by Ferric reducing/antioxidant power (FRAP) assay or Ferric reducing/antioxidant power using ferric tripyridyltriazine (FRAP-TPTZ) assay. 7. The method of claim 1, wherein the solid phase is a surface of a cover slip, slide, tube, microtiter well, sheet, chip, reaction tray, strip, membrane, film, fiber, plate, bottle, or box. 8. The method of claim 1, wherein the solid phase is a particle. 9. The method of claim 1, wherein the urine sample of the non-pregnant female is obtained around a time of ovulation or middle of the menstrual cycle. 10. The method of claim 1, wherein the fluorophore is green fluorescent protein (GFP), enhanced GFP (EGFP), fluorescein, or its derivatives. 11. The method of claim 1, wherein the urine sample of the pregnant female is obtained during a period ranging from about a first day of a missed menstruation to about 40 weeks of pregnancy. 12. The method of claim 11, wherein the urine sample is obtained during a period ranging from about 5 weeks to about 15 weeks of pregnancy. 13. The method of claim 1, wherein the chromogenic chemical comprises an oxidation-reduction sensitive metallic ion. 14. The method of claim 13, wherein the metallic ion is selected from the group consisting of copper, iron, chromium, tungsten and molybdenum ions in an oxidized state. 15. The method of claim 1, wherein the net redox activity is measured using an electrochemical sensor. 16. The method of claim 1, further comprising processing the urine sample prior to passing the aged urine sample over the solid surface. 17. The method of claim 16, wherein the urine sample is aged for about 1 week to about 52 weeks at room temperature ranging from about 20.degree. C. to about 30.degree. C. 18. The method of claim 16, wherein the processing comprises chemical, biochemical, physical, or biological means. 19. The method of claim 16, wherein the processing comprises enzymatic treatment. 20. The method of claim 16, wherein the processing comprises extraction. 21. The method of claim 16, wherein the processing comprises purification. 22. The method of claim 16, wherein the processing comprises using adsorbants selected from the group consisting of: talc; silica-based particles such as silica gel, alumina, florisil, charcoal, kaolin, concanavaline A and its conjugates; calcium phosphate; calcium hydroxide; calcium chloride; Cetyltrimethyl ammonium bromide; lectin, protein or glycoprotein hydrolyzing enzymes; glassfiber filter; ion exchange resins; affinity ligands; organic solvents; solid phase extractants; size exclusion sieves; and reverse phase chromatographic materials. 23. The method of claim 16, wherein the processing comprises using precipitants. 24. The method of claim 23, wherein the precipitants comprise heavy metals selected from the group consisting of: barium, lead, molybdenum, and tungsten. 25. The method of claim 23, wherein the precipitants are selected from the group consisting of: barium chloride, barium hydroxide, zinc chloride, mercuric chloride, lead acetate, ammonium sulphate, dextran, acetonitrile, chloroform, sodium hydroxide, trichloroacetic acid, potassium iodate, and their mixtures. 26. The method of claim 1, wherein the at least one redox indicator is methylene blue or the redox sensitive polymer. 27. The method of claim 26, wherein the redox sensitive polymer is polyaniline. 28. The method of claim 16, wherein the processing comprises using hydrochloric acid or sulfuric acid. 29. The method of claim 1, wherein the net redox activity compared to the known net redox activity of the at least one standard indicates a net oxidizing activity. 30. The method of claim 29, wherein the net oxidizing activity indicates a male gender of the unborn child or a male gender specific compatibility of the ovum. 31. The method of claim 1, wherein the net redox activity compared to the known net redox activity of the at least one standard indicates a net reducing activity. 32. The method of claim 31, wherein the net reducing activity indicates a female gender of the unborn child or a female gender specific compatibility of the ovum.

Details for Patent 10,018,625

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	01/15/1974		2028-03-11
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	12/27/1984		2028-03-11
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	02/15/1985		2028-03-11
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	02/16/1990		2028-03-11
Bel-mar Laboratories, Inc.	CHORIONIC GONADOTROPIN	chorionic gonadotropin	Injection	017054	03/26/1974		2028-03-11
Fresenius Kabi Usa, Llc	CHORIONIC GONADOTROPIN	chorionic gonadotropin	For Injection	017067	03/05/1973		2028-03-11