PATENT CLAIM ANALYSIS

Application Number: 16324365
Application Type: Utility
Filing Date: 2019-02
Publication Date: 2019-06
Patent Classification: ["435", "006140"]

Abstract:
The present technology relates to methods for excluding Lynch syndrome as a possible diagnosis in patients suffering from colorectal cancers or endometrial cancers. These methods are based on detecting the methylation status of the MLH1 promoter ‘C’ region in colorectal and endometrial cancer patients using an improved and highly sensitive methylation-specific multiplex ligation-dependent probe amplification (MS-MLPA) assay.

Claim (Index 1):
A method for detecting methylation of a target nucleic acid sequence in the promoter of MLH1 in a sample comprising\n (a) incubating the sample comprising double-stranded genomic DNA with a methylation-sensitive restriction enzyme, wherein\n (i) the methylation-sensitive restriction enzyme cleaves the double-stranded genomic DNA at unmethylated recognition sites for the methylation-sensitive restriction enzyme, leaving methylated recognition sites for the methylation-sensitive restriction enzyme intact; \n (ii) a first target nucleic acid sequence in the promoter of MLH1 in the sample comprises a recognition site for the methylation-sensitive restriction enzyme; and \n (iii) a second target nucleic acid sequence at Chr7:5534789-5534896 in the ACTB (beta-actin) gene in the sample comprises a recognition site for the methylation-sensitive restriction enzyme; \n (b) incubating the sample with a plurality of probes for querying a plurality of target nucleic acids in the sample, wherein the plurality of probes comprises\n (i) a first locus specific probe comprising a first target specific region complementary to the first target nucleic acid sequence in the promoter of MLH1; and \n (ii) a second locus specific probe comprising a second target specific region complementary to the second target nucleic acid sequence at Chr7:5534789-5534896 in the ACTB gene, wherein the first locus specific probe and second locus specific probe are detectably labelled; \n (c) hybridizing the plurality of probes to the plurality of target nucleic acids in the sample to form a plurality of hybridization complexes; (d) amplifying the plurality of hybridization complexes to produce a plurality of amplicons, wherein amplification is carried out with a plurality of primer sets comprising\n (i) a first forward primer comprising a region that is complementary to a nucleic acid sequence located 5\u2032 from the first target nucleic acid sequence in the promoter of MLH1; \n (ii) a first reverse primer comprising a region that is complementary to a nucleic acid sequence located 3\u2032 from the first target nucleic acid sequence in the promoter of MLH1; \n (iii) a second forward primer comprising a region that is complementary to a nucleic acid sequence located 5\u2032 from the second target nucleic acid sequence at Chr7:5534789-5534896 in the ACTB gene; and \n (iv) a second reverse primer comprising a region that is complementary to a nucleic acid sequence located 3\u2032 from the second target nucleic acid sequence at Chr7:5534789-5534896 in the ACTB gene; and \n (e) detecting the plurality of amplicons, wherein detecting an amplicon comprising the first target nucleic acid sequence in the promoter of MLH1 indicates methylation of the first target nucleic acid sequence in the promoter of MLH1 in the sample.

Metadata:
- Claim Count in Document: 58.0
- Percentile: 99.0
- Lexical Diversity: 1.16667
- Patent Class: 435.0
- Transitional Phrase Type: open
- Component Type: 1
- Foreign Priority: False
- Related Applications: ['15300399', '10971339', '12476981', '11518353', '14775876']

Analysis Scores:
- 35 USC 101 Eligibility (BERT): 0.5871809498575397
- 35 USC 102 Novelty (BERT): 0.5223695618803894
- Combined Prediction Score: 0.5806998110598246
- Mean Citation Score: 321.436012
- Max Citation Score: 329.37662
- Similarity Product: 260.18278044097417

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

Dataset: test