PATENT CLAIM ANALYSIS

Application Number: 15745207
Application Type: Utility
Filing Date: 2018-01
Publication Date: 2018-12
Patent Classification: ["435", "069700"]

Abstract:
Disclosed in the present invention is a long-acting recombinant human follicle-stimulating hormone-Fc fusion protein (referred to as hFSH-Fc for short) and a preparation method thereof, wherein the hFSH-Fc protein is a dimerized fusion protein and the amino acid sequence thereof successively comprises an hFSHβ subunit, CTP, an hFSHα subunit, a flexible peptide linker and human IgG2 Fc variant from N-terminal to C-terminal. Also disclosed in the present invention is the use of the recombinant hFSH-Fc fusion protein composition in preparing drugs in the animal breeding field.

Claim (Index 6):
A method of preparing the recombinant hFSH-Fc fusion protein of  claim 1 , comprising the following steps:\n i) constructing a gene expression vector encoding the recombinant hFSH-Fc fusion protein: a gene encoding the hFSH-Fc fusion protein is obtained by a DNA synthetic method, and is inserted into a mammalian cell expression vector, and thus an expression plasmid containing the gene encoding the hFSH-Fc fusion protein is obtained; ii) stably expressing the recombinant hFSH-Fc fusion protein in mammalian host cells: the expression vector containing the gene encoding the hFSH-Fc fusion protein is transfected into the mammalian host cells, and a cell strain with stable expression of hFSH-Fc fusion protein is screened; iii) culturing high-density cells for the production of the recombinant hFSH-Fc fusion protein: the above-mentioned screened stable cell strain is transferred into a shake flask or a bioreactor to scale up cell production; when the cell density reaches 1\u00d710 7 /mL, the temperature is reduced from 37\u00b0 C. to 33\u00b0 C., and cultivation is performed at this temperature till the expression yield no longer increases; iv) purifying and preparing the recombinant hFSH-Fc fusion protein: a) Protein A affinity chromatography: performing centrifugation, collecting the supernatant, and performing chromatography using Protein A affinity column according to the characteristics of a protein-coupled Fc fragment of the present disclosure; b) purification by hydrophobic chromatographic column: performing hydrophobic chromatographic purification to further remove the impurities in target protein after Protein A purification; the hydrophobic column includes Butyl Sepharose 4 Fast Flow, Octyl Sepharose 4 Fast Flow, Phenyl Sepharose 6 Fast Flow, Butyl-S Sepharose 6 Fast Flow, Butyl Sepharose 4B, Octyl Sepharose CL-4B, Phenyl Sepharose CL-4B; preferably, Phenyl Sepharose 6 Fast Flow.

Metadata:
- Claim Count in Document: 1.0
- Percentile: 86.0
- Lexical Diversity: 1.59322
- Patent Class: 435.0
- Transitional Phrase Type: open
- Component Type: 1
- Foreign Priority: True
- Related Applications: ['11045022', '10112321', '10119427', '14898698', '11490825']

Analysis Scores:
- 35 USC 101 Eligibility (BERT): 0.6012203867015932
- 35 USC 102 Novelty (BERT): 0.5188484579986186
- Combined Prediction Score: 0.5929831938312957
- Mean Citation Score: 329.981784
- Max Citation Score: 334.7434
- Similarity Product: 242.4207148257375

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

Dataset: test