# US 11,029,318 B2 · Methods for predicting and treating patients with increased risk of adverse pregnancy outcome > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,029,318 B2 - Document ID: US11029318B2 - Status: Granted - Kind: B2 - Application number: 15/756,294 - Filed: 2016-08-26 - Published: 2018-09-27 - Granted: 2021-06-08 - Earliest claimed: 2015-08-28 - Assignees: Kypha, Inc. - Applicants: Kypha, Inc. - Inventors: Nicholas Staten; Alfred Kim; Paul Olson - Web page: https://patentgrep.com/patent/US11029318B2 ## CPC - G01N 33/6893: {related to diseases not provided for elsewhere} - A61K 31/573: substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone - A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca - G01N 33/68: involving proteins, peptides or amino acids {(involving lipoproteins G01N33/92)} - G01N 2800/52: Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis - 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) ## Abstract In some embodiments, the present invention provides methods for treating pregnant patients at risk of adverse pregnancy outcome, including, in some embodiments, by measuring one or more of a level of iC3b, intact C3, and total C3. ## Claims ### Claim 1 A method for treating a pregnant human at risk of an adverse pregnancy outcome comprising: (i) detecting in a first sample of blood or urine from the pregnant human a first level of iC3b, intact C3, and/or total C3 at a first time point during the first, second, or third trimester of pregnancy; (ii) detecting in a second sample of blood or urine from the pregnant human a second level of iC3b, intact C3, and/or total C3 at a second time point during the third trimester of pregnancy; (iii) comparing the first and second levels; (iv) diagnosing the pregnant human as being at risk of an adverse pregnancy outcome by determining that the first and second levels are: (a) iC3b and the second level is higher than the first level; and/or (b) iC3b and intact C3 and the ratio of intact C3 to iC3b is the same as or lower than the first level; and/or (c) total C3 and the second level is the same as or lower than the first level; and (v) treating the pregnant human diagnosed as being at risk of an adverse pregnancy outcome with a treatment comprising administration of one or more of steroids, non-steroidal anti-inflammatory drugs (NSAIDs), hydroxychloroquine, chloroquine, quinacrine, methotrexate, azathioprine, cyclophosphamide, chlorambucil, cyclosporine, mycophenolate mofetil, rituximab, belimumab, complement inhibitors, plasmapheresis, delivery of the fetus, aspirin, one or more agents for treatment of hypertension, and/or one or more agents for treatment of eclamptic seizures. ### Claim 2 (depends on 1) The method of claim 1, wherein one or more antibodies is used to determine the first and/or second levels of iC3b, intact C3 and/or total C3 in the first or second samples. ### Claim 3 (depends on 2) The method of claim 2, wherein a lateral flow assay is used to determine the first and/or second levels of iC3b, intact C3 and/or total C3 in the first or second samples. ### Claim 4 (depends on 1) The method of claim 1, wherein the treatment is or comprises part of a combination therapy administered to the subject. ### Claim 5 (depends on 1) The method of claim 1, wherein the blood comprises whole blood, serum, plasma, or any combination thereof. ### Claim 6 A method for treating a pregnant human at risk of an adverse pregnancy outcome comprising: (i) detecting in a sample of blood or urine from the pregnant human a level of iC3b, total C3, and/or iC3b and intact C3, during the first, second, or third trimester of pregnancy; (ii) comparing the level of total C3, iC3b, and/or iC3b and intact C3 from the pregnant human to one or more reference levels; (iii) diagnosing the pregnant human as being at risk of an adverse pregnancy outcome by determining that the level from the pregnant human is outside of a range of normal levels; and (iv) treating the pregnant human diagnosed as being at risk of an adverse pregnancy outcome with a treatment comprising-administration of one or more of steroids, non-steroidal anti-inflammatory drugs (NSAIDs), hydroxychloroquine, chloroquine, quinacrine, methotrexate, azathioprine, cyclophosphamide, chlorambucil, cyclosporine, mycophenolate mofetil, rituximab, belimumab, complement inhibitors, plasmapheresis, delivery of the fetus, aspirin, one or more agents for treatment of hypertension, and/or one or more agents for treatment of eclamptic seizures. ### Claim 7 (depends on 1, 6) The method of claim 1 or claim 6, wherein the risk is determined between about one day and about three months before it occurs. ### Claim 8 (depends on 1, 6) The method of claim 1 or claim 6, wherein, after administration of the one or more treatments, the adverse pregnancy outcome does not occur. ### Claim 9 (depends on 6) The method of claim 6, wherein one or more antibodies is used to determine the level of iC3b, intact C3 and/or total C3 in the sample. ### Claim 10 (depends on 6) The method of claim 6, wherein a lateral flow assay is used to determine the level of iC3b, intact C3 and/or total C3 in the sample. ### Claim 11 (depends on 6) The method of claim 6, wherein the blood comprises whole blood, serum, plasma, or any combination thereof. ### Claim 12 (depends on 6) The method of claim 6 wherein the treatment is or comprises part of a combination therapy administered to the subject.