PATENT CLAIM ANALYSIS

Application Number: 15967276
Application Type: Utility
Filing Date: 2018-04
Publication Date: 2018-12
Patent Classification: ["540", "555000"]

Abstract:
Disclosed are formulations, including both liquid and lyophilized formulations, comprising a benzodiazepine antibody-drug conjugate (ADC) and a cyclodextrin. Also disclosed are methods of purifying mixtures comprising benzodiazepine antibody-drug conjugates and process drug-related impurities.

Claim (Index 65):
A pharmaceutically acceptable formulation comprised of\n (a) benzodiazepine ADC having the structure of: or a pharmaceutically acceptable salt thereof, wherein Ab is a monoclonal antibody that specifically to an extracellular domain of human CD33, wherein the monoclonal antibody is h2H16ec having a variable light chain sequence comprising the amino acid sequence set forth in SEQ ID NO: 3 and a variable heavy chain sequence comprising the amino acid sequence set forth in SEQ ID NO:4 engineered to have introduced cyteine residues at position 239 (EU index numbering); S represents the sulfur atoms from the engineered cysteine residue; subscript p, which represents the average number of conjugated drug-linker molecules per monoclonal antibody in the formulation, is about 2, wherein conjugation of the drug-linker molecules is to the sulfur atoms of the introduced cyteine residues; and wherein the concentration of the benzodiazepine ADC ranges from 1.3 mg/mL to 3.1 mg/mL; (b) no more that 0.1 \u03bcM of a benzodiazepine-related impurity having the structure of: or a pharmaceutically acceptable salt thereof (c) 6% w/v of a chemically modified cyclodextrin, wherein the chemically modified cyclodextrin is hydroxypropyl-\u03b2-cyclodextrin; (d) a lyoprotectant, wherein the lyoproptectant is 6% w/v sucrose; and (e) a diluent, wherein the diluent is 20 mM KPhos buffer at a pH of 7.3.

Metadata:
- Claim Count in Document: 2.0
- Percentile: 91.0
- Lexical Diversity: 1.34483
- Patent Class: 540.0
- Transitional Phrase Type: open
- Component Type: 1
- Foreign Priority: False
- Related Applications: ['14774372', '15454953', '15038235', '14774348', '10591743']

Analysis Scores:
- 35 USC 101 Eligibility (BERT): 0.6156219975017102
- 35 USC 102 Novelty (BERT): 0.545508332146164
- Combined Prediction Score: 0.6086106309661556
- Mean Citation Score: 232.987138
- Max Citation Score: 371.28378
- Similarity Product: 248.0892385067833

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