PATENT CLAIM ANALYSIS

Application Number: 15952379
Application Type: Utility
Filing Date: 2018-04
Publication Date: 2018-08
Patent Classification: ["436", "518000"]

Abstract:
Methods and compositions are provided for diagnosing ectopic pregnancy in a mammalian subject by detecting changes in expression of ISM2, ADAM12, PST1, PSG7, PST11, PSG9, PSG2 and other genes identified therein, including combinations thereof. A selected gene, gene transcript or protein/peptide expression product, or profiles or signatures formed by combinations of same, detected in a biological fluid of a subject, enables comparison of the corresponding genes, proteins or profiles from that of a reference or control having a normal intrauterine pregnancy. Detection of characteristic changes in the gene profile or protein expression signature of the subject is correlated with a diagnosis of ectopic pregnancy. Various compositions for use in such diagnosis include PCR primer-probe sets or ligands, labeled or immobilized, which are capable of detecting the changes in expression or translation of these targets.

Claim (Index 1):
A method for diagnosing an ectopic pregnancy in a female mammalian subject comprising:\n (a) measuring in a biological fluid sample of the subject the expression levels of Isthmin2 (ISM2) protein or peptide and one or more proteins or peptides selected from the group consisting of:\n i. the pro-domain or extracellular (EC) domain of ADAM12, \n ii. pregnancy specific beta-1 glycoprotein isoform 1 (PSG1), \n iii. pregnancy specific beta-1 glycoprotein isoform 7 (PSG7), \n iv. pregnancy specific beta-1 glycoprotein isoform 11 (PSG11), \n v. pregnancy specific beta-1 glycoprotein isoform 9 (PSG9), and \n vi. pregnancy specific beta-1 glycoprotein isoform 2 (PSG2); \n wherein the expression level of each said protein or peptide is measured by a ligand which binds to the protein or peptide; and \n (b) optionally, measuring in said biological fluid sample of the subject the expression level of a protein or peptide selected from the group consisting of:\n vii. choriogonadotropin subunit beta precursor (CGB); \n viii. glycoprotein hormones alpha chain precursor (CGA); \n ix. pappalysin-1 precursor (PAPPA); \n x. chorionic somatomammotropin hormone precursor (CSH1); and \n xi. progestagen-associated endometrial protein (PAEP); \n wherein the expression level of each said selected protein or peptide is measured by a ligand which binds to the protein or peptide; and \n (c) comparing said subject's selected protein or peptide expression levels with the levels of the same protein or peptide in the biological fluid of a reference or control female mammalian subject having a normal intrauterine pregnancy (IUP), wherein changes in expression of the subject's selected proteins or peptides from those of the reference or control correlates with a diagnosis of ectopic pregnancy.

Metadata:
- Claim Count in Document: 3.0
- Percentile: 91.0
- Lexical Diversity: 1.80952
- Patent Class: 436.0
- Transitional Phrase Type: open
- Component Type: 1
- Foreign Priority: False
- Related Applications: ['15386714', '13397442', '15884691', '14045452', '13467661']

Analysis Scores:
- 35 USC 101 Eligibility (BERT): 0.6544292291255801
- 35 USC 102 Novelty (BERT): 0.6660228184233649
- Combined Prediction Score: 0.6555885880553586
- Mean Citation Score: 444.073864
- Max Citation Score: 663.9117
- Similarity Product: 658.0377577975987

Labels:
- Claim Label 101: 1
- Claim Label 102: 0
- Claim Label 103: 1
- Claim Label 112: 1
- Combined Label: 0
- Label 101 Adjusted: 1

Dataset: test