PATENT CLAIM ANALYSIS

Application Number: 15907470
Application Type: Utility
Filing Date: 2018-02
Publication Date: 2018-09
Patent Classification: ["435", "440000"]

Abstract:
The present invention relates to an improved method for cell line development which is generally applicable to production of any therapeutic protein that can be produced using mammalian Cell lines and in particular Chinese Hamster Ovary (CHO) cells. The method combines site directed integration (SDI), expression construct components improving the post-transcriptional processing of the gene of interest (GOI), novel design of the GOI genome target location and the introduction of a onetime pre-CLD host cell line selection workflow to generate a production competent cell line that can then be used in multiple CLD efforts from that point on.

Claim (Index 13):
A method for mammalian cell line development comprising the following steps:\n (a) providing a cell or cell population from a mammalian cell bank developed according to  claim 1  and (i) having a final template DNA construct with a template protein of interest coding region including promoter(s), a first selection marker coding region including promoter(s) and a sequence z being unique or rare in the total genome sequence of said cell or cell population and wherein said coding regions and said sequence z can be in any order (ii) said final template DNA construct being flanked by two sequence stretches X and Y being unique or rare in the genome of said cell; (b) providing a matching expression vector in the form of a plasmid containing sequence stretches X\u2032 and Y\u2032 being homologous to said sequence stretches X and Y and wherein said sequences X\u2032 and Y\u2032 flanks a desired protein of interest coding region including promoter(s) and a second selection marker coding region including promoter(s); (c) introducing vector(s) coding for a gene editing nuclease with specificity for sequence z together with said expression vector into said cell or cell population and wherein said gene editing nuclease is designed using any available technology platform such as zinc finger nucleases, meganucleases, TALENs or CRISPR/Cas9 designs; (d) said genome editing nuclease generates a double strand break at sequence z catalyzing exchange of the regions flanked by said sequences X and Y in said template DNA construct and sequences X\u2032 and Y\u2032 in said expression vector via cellular DNA repair mechanisms; (e) a cell or cells having undergone correct cassette exchange only are selected via the use of selection marker(s) and/or genetic characterization.

Metadata:
- Claim Count in Document: 24.0
- Percentile: 88.0
- Lexical Diversity: 1.38462
- Patent Class: 435.0
- Transitional Phrase Type: open
- Component Type: 1
- Foreign Priority: True
- Related Applications: ['14967689', '14092786', '13752647', '12793898', '12507252']

Analysis Scores:
- 35 USC 101 Eligibility (BERT): 0.5852642655710985
- 35 USC 102 Novelty (BERT): 0.5186370924441456
- Combined Prediction Score: 0.5786015482584032
- Mean Citation Score: 308.898376
- Max Citation Score: 313.97794
- Similarity Product: 240.4894831206584

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

Dataset: test