IP Library Granted Patent US 12,287,340
Granted Patent B2
US 12,287,340 · App. 18/414,339 · Granted Apr 29, 2025

Kits and methods to distinguish false labor and true labor

Inventors: Adi L. Tarca (South Lyon, MI); Piya Chaemsaithong (Shatin, HK); Tinnakorn Chaiworapongsa (Grosse Pointe Park, MI); Sonia S. Hassan (Novi, MI); Roberto Romero (Grosse Pointe, MI)
Assignees: Wayne State University; The United States of America, as Represented by the Secretary, Department of Health & Human Services
G01N33/689G01N33/543G06F17/18G16B5/00G16B5/20C12Y101/01205C12Y504/02G01N2333/4727G01N2800/368
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 12,287,340
App. No.
18/414,339
Granted
Apr 29, 2025
Kind
B2
Abstract

Kits and methods to distinguish between false and true labor are provided. The kits and methods can utilize differences in abundance and/or differences in the rate of change in abundance of B7-H2, SORC2, TF, C1-Esterase Inhibitor, Ran, IMDH1 and/or PGAM1, as markers of true labor.

Claims (15)

1. A kit comprising: an array that measures tissue factor (TF) in combination with Ras-related Nuclear protein (Ran), Inosine-5′-monophosphate dehydrogenase (IMDH1), and Phosphoglycerate mutase 1 (PGAM1), from a sample obtained from a pregnant female.

2. The kit of claim 1 comprising instructions that direct calculation of changes in abundance (CA) of TF, Ran, IMDH1, and PGAM1 as compared to a reference level calculated from samples derived from a reference population, at a time when members of said reference population were not in true labor.

3. The kit of claim 2 comprising instructions that direct calculation of a true labor score using change of abundance of true labor markers, wherein CA TF , CA Ran , CA IMDH1 , and CA PGAM1 are used in a Linear Discriminant Analysis Model.

4. The kit of claim 3 comprising instructions that direct analysis of the true labor score;

wherein the true labor score comprises two threshold values, X and Y,

wherein a true labor score≤X denotes that the pregnant female is in false labor, and

wherein a true labor score>Y denotes that the pregnant female is in true labor.

5. The kit of claim 1 , comprising instructions that direct sample collection be obtained from a pregnant female between 33 and 40 weeks of the female's pregnancy.

6. The kit of claim 1 , comprising instructions to collect a plasma or serum sample.

7. The kit of claim 1 , comprising instructions to collect the sample when the pregnant female is experiencing symptoms associated with false labor and true labor, wherein the symptoms optionally are contractions.

8. The kit of claim 1 , wherein the array comprises one or more well(s) coated with:

anti-TF antibodies; and/or

anti-Ran antibodies; and/or

anti-IMDH1 antibodies; and/or

anti-PGAM1 antibodies.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 18, 2024
From: TARCA, ADI L.; CHAEMSAITHONG, PIYA; CHAIWORAPONGSA, TINNAKORN; HASSAN, SONIA S.
To: WAYNE STATE UNIVERSITY
Reel/Frame 066163/0373 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 18, 2024
From: ROMERO, ROBERTO
To: THE UNITED STATES OF AMERICA, AS REPRESENTED BY THE SECRETARY, DEPARTMENT OF HEALTH & HUMAN SERVICES
Reel/Frame 066163/0473 →
Continuity (4)
Continuation 17525717 · Nov 12, 2021
Division 15773980
Provisional Application 62251517 · Nov 5, 2015
Related Publication 20240192226A1 · Jun 13, 2024
References Cited (21)
US 4444879A · Foster et al. · 1984 [cited by applicant]
US 5420016A · Boguslaski et al. · 1995 [cited by applicant]
US 5516702A · Senyei et al. · 1996 [cited by applicant]
US 11204354B2 · Tarca · 2021 [cited by examiner]
US 20020095073A1 · Jacobs et al. · 2002 [cited by applicant]
US 20070178605A1 · Mor et al. · 2007 [cited by applicant]
US 20110223622A1 · Smith · 2011 [cited by applicant]
US 20140045915A1 · Skog et al. · 2014 [cited by applicant]
US 20140186332A1 · Ezrin et al. · 2014 [cited by applicant]
US 20170335395A1 · Chen-Plotkin · 2017 [cited by examiner]
US 20180321250A1 · Tarca et al. · 2018 [cited by applicant]
WO WO201202194 · 2012 [cited by applicant]
Dayarian, et al., “Predicting protein phosphorylation from gene expression: top methods from the IMPROVER Species Translation Challenge,” Bioinformatics, vol. 31, No. 4, 2015, pp. 462-470. [cited by applicant]
Di Quinzio, et al., “Proteomic analysis of human cervico-vaginal fluid displays differential protein expression in association with labor onset at term,” Journal of Proteome Research, vol. 7, No. 5, 2008, pp. 1916-1921. [cited by applicant]
Erez, et al., “High tissue factor activity and low tissue factor pathway inhibitor concentrations in patients with preterm labor”, Hournal of Maternal-Fetal & Neonatal Medicine, Aug. 15, 2012, vol. 23, No. 1, pp. 23-33. [cited by applicant]
Heng, et al., “Human cervicovaginal fluid biomarkers to predict term and preterm labor,” Frontiers in Physiology, vol. 6, No. 151, 2015, 18 pages. [cited by applicant]
Keren-Politansky, et al., “The coagulation profile of preterm delivery,” Thrombosis Research, vol. 133, No. 4, 2014, pp. 585-589. [cited by applicant]
Mittal, et al., “Characterization of the myometrial transcriptome and biological pathways of spontaneous human labor at term”, Journal of Perinatal Medicine, Nov. 30, 2010, vol. 38, No. 6, pp. 617-643. [cited by applicant]
Tarca, et al., “Methodological approach from the Best Overall Team in the sbv IMPROVER Diagnostic Signature Challenge,” Systems Biomedicine, vol. 1, No. 4, 2013, pp. 217-227. [cited by applicant]
Tarca, et al., “Strengths and limitations of microarray-based phenotype prediction: lessons learned from the IMPROVER Diagnostic Signature Challenge,” Bioinformatics, vol. 29, No. 22, 2013, pp. 2892-2899. [cited by applicant]
Tarca, et al., “The prediction of early preeclampsia: Results from a longitudinal proteomics study,” PLoS One, vol. 14, No. 6, 2019, 34 pages. [cited by applicant]