# US 7,744,864 B2 · Method for identifying a patient at risk of having difficulty in sustaining a pregnancy > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 7,744,864 B2 - Document ID: US7744864B2 - Status: Granted - Kind: B2 - Application number: 12/116,401 - Filed: 2008-05-07 - Published: 2008-09-04 - Granted: 2010-06-29 - Earliest claimed: 2003-10-24 - Assignees: Nora Therapeutics, Inc. - Inventors: Darryl Carter - Web page: https://patentgrep.com/patent/US7744864B2 ## CPC - G01N 33/689: {related to pregnancy or the gonads} - A61K 31/675: having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate - A61K 31/7076: containing purines, e.g. adenosine, adenylic acid - A61K 35/28: Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells - A61K 38/193: {Colony stimulating factors [CSF]} - A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca - A61P 9/12: Antihypertensives - A61P 15/00: Drugs for genital or sexual disorders (for disorders of sex hormones A61P5/24); Contraceptives - A61P 15/06: Antiabortive agents; Labour repressants - A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] - A61P 37/06: Immunosuppressants, e.g. drugs for graft rejection - A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 - C07K 14/535: Granulocyte CSF; Granulocyte-macrophage CSF - G01N 33/6893: {related to diseases not provided for elsewhere} - G01N 2800/368: Pregnancy complicated by disease or abnormalities of pregnancy, e.g. preeclampsia, preterm labour - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS - C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00) ## Abstract Compositions, kits and methods for the prevention of, for example, spontaneous abortion, preeclampsia, preterm labor or implantation failure during assisted reproduction are provided. The compositions, kits and methods provide an effective amount of granulocyte colony stimulating factor to prevent, for example, spontaneous abortion, preeclampsia, preterm labor or implantation failure of an embryo. ## Claims ### Claim 1 A method for identifying and treating a patient at risk of having difficulty in sustaining a pregnancy, having difficulty in having in vitro fertilized embryos implant, having preeclampsia or having premature labor comprising: determining, in a tissue sample from said patient prior to pregnancy, at least one of the parameters selected from the group consisting of the Th1 cell number, Th2 cell number, Th1 cell activity, Th2 cell activity, the amount of a Th1 cell product, and the amount of a Th2 cell product; identifying the patient as one having a high risk of having difficulty in sustaining a pregnancy, having difficulty in having in vitro fertilized embryos implanted, having preeclampsia or having premature labor if the patient meets one or more of the criteria selected from the group consisting of elevated Th1 cell number, elevated Th1 cell activity, elevated amount of a Th1 cell product, decreased Th2 cell number, decreased Th2 cell activity, decreased amount of a Th2 cell product, a higher ratio of Th1 cell number to Th2 cell number, and a higher ratio of Th1 cell activity to Th2 cell activity; and treating the patient with an effective mount of G-CSF, if the patient is identified as having a high risk of having difficulty in sustaining a pregnancy, having difficulty in having in vitro fertilized embryos implanted, or having preeclampsia. ### Claim 2 (depends on 1) The method of claim 1, wherein the Th1 cell product is interferon γ. ### Claim 3 (depends on 1) The method of claim 1, wherein the Th1 cell product is tumor necrosis factor β. ### Claim 4 (depends on 1) The method of claim 1, wherein the Th1 cell product is IL-2. ### Claim 5 (depends on 1) The method of claim 1, wherein the Th2 cell product is selected from the group consisting of IL3, IL-4, IL-5, IL-6, IL-10, IL-13, and combinations thereof. ### Claim 6 (depends on 5) The method of claim 5, wherein the Th2 cell product is IL-3, IL-4, IL-6, IL-10 or combinations thereof. ### Claim 7 (depends on 1) The method of claim 1, wherein said tissue sample is a blood sample. ### Claim 8 (depends on 1) The method of claim 1, wherein said tissue sample is a blood sample. ### Claim 9 A method for identifying and treating a subject with G-CSF to reduce the risk of having difficulty in sustaining a pregnancy, having difficulty in having in vitro fertilized embryos implant, or having preeclampsia, the method comprising: determining, in a tissue sample from said subject, one or more of the parameters selected from the group consisting of the Th1 cell number, Th2 cell number, Th1 cell activity, Th2 cell activity, the amount of a Th1 cell product, and the amount of a Th2 cell product; identifying the subject as a candidate for a G-CSF treatment if the subject meets one or more of the criteria selected from the group consisting of elevated Th1 cell number, elevated Th1 cell activity, elevated amount of a Th1 cell product, decreased Th2 cell number, decreased Th2 cell activity, decreased amount of a Th2 cell product, a higher ratio of Th1 cell number to Th2 cell number, and a higher ratio of Th1 cell activity to Th2 cell activity; and treating the subject with an effective mount of G-CSF, if the subject is identified as a candidate for G-CSF treatment. ### Claim 10 (depends on 9) The method of claim 9, wherein the Th1 cell product is interferon γ. ### Claim 11 (depends on 9) The method of claim 9, wherein the Th1 cell product is tumor necrosis factor β. ### Claim 12 (depends on 9) The method of claim 9, wherein the Th1 cell product is IL-2. ### Claim 13 (depends on 9) The method of claim 9, wherein said tissue sample is a blood sample.