PATENT CLAIM ANALYSIS

Application Number: 15861036
Application Type: Utility
Filing Date: 2018-01
Publication Date: 2018-05
Patent Classification: ["530", "300000"]

Abstract:
Methods for analyzing, selecting, characterizing or classifying compositions of a co-polymer, e.g., glatiramer acetate are described. The methods entail analysis of pyro-glutamate in the composition, and, in some methods, comparing the amount of pyro-glutamate present in a composition to a reference standard.

Claim (Index 2):
A method for manufacturing a pharmaceutical composition comprising glatiramer acetate, the method comprising:\n preparing an amino acid copolymer of L-glutamic acid, L-alanine, L-lysine, and L-tyrosine, wherein the preparing step comprises co-polymerizing N-carboxy anhydrides of L-alanine, benzyl-protected L-glutamic acid, trifluoroacetic acid (TFA)-protected L-lysine, and L-tyrosine to generate a first material; treating the first material to deprotect the benzyl-protected L-glutamic acid therein and to partially depolymerize the first material, thereby generating a second material; treating the second material to deprotect the TFA-protected L-lysine to produce a third material; and purifying the third material, to thereby produce the copolymer of L-glutamic acid, L-alanine, L-lysine, and L-tyrosine; measuring the pyro-glutamate content of the second material in a sample of the second material or measuring the pyro-glutamate content of the third material in a sample of the third material copolymer in a sample of the copolymer; processing the copolymer to produce a pharmaceutical composition comprising glatiramer acetate only if the measured pyro-glutamate content in the sample of the second material or the sample of the third material is within 2000-7000 parts per million (ppm) on a dry weight/dry weight basis, thereby producing a pharmaceutical composition comprising glatiramer acetate.

Metadata:
- Claim Count in Document: 39.0
- Percentile: 86.0
- Lexical Diversity: 1.5
- Patent Class: 530.0
- Transitional Phrase Type: open
- Component Type: 1
- Foreign Priority: False
- Related Applications: ['14795867', '14019119', '12408058', '13709586', '12754344']

Analysis Scores:
- 35 USC 101 Eligibility (BERT): 0.7490939507444804
- 35 USC 102 Novelty (BERT): 0.6566508332134761
- Combined Prediction Score: 0.7398496389913799
- Mean Citation Score: 588.759376
- Max Citation Score: 629.3493
- Similarity Product: 623.8580476593373

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