PATENT CLAIM ANALYSIS

Application Number: 16393697
Application Type: Utility
Filing Date: 2019-04
Publication Date: 2019-08
Patent Classification: ["424", "400000"]

Abstract:
Stable formulation of L-cysteine hydrochloride amenable to terminal sterilization; a terminally sterilized stable formulation of L-cysteine hydrochloride; a process of manufacturing a stable formulation of L-cysteine hydrochloride amenable to terminal sterilization; and a container comprising the formulations of the invention.

Claim (Index 20):
A process of manufacturing a terminally steam sterilized pharmaceutical composition, wherein the composition comprises L-cysteine hydrochloride, the process comprising the following steps:\n (i) adding a pharmaceutically acceptable vehicle to a batch container comprising:\n (a) a top side comprising an opening; and \n (b) a pressurizing means, \n (ii) purging the batch container with nitrogen gas; (iii) mixing the drug vehicle; (iv) adding L-cysteine hydrochloride monohydrate to the pharmaceutically acceptable vehicle to create the pharmaceutical composition; (v) mixing the pharmaceutical composition until the L-cysteine hydrochloride monohydrate is dissolved in the pharmaceutically acceptable vehicle; (vi) sealing the opening of the top side of the batch container; (vii) pressurizing the batch container with nitrogen gas; (viii) optionally, sterilizing stoppers, preferably in sterilization bags, preferably at about 121\u00b0 C. and preferably for 30 minutes; (ix) optionally, sterilizing filling equipment, preferably at about 121\u00b0 C., preferably for 30 minutes, and preferably wrapping filling equipment prior to sterilization; (x) optionally, washing vials with water for injection and depyrogenating vials in a depyrogenation oven; (xi) optionally, filling a product container with the pharmaceutical composition from the batch container using filling equipment; (xii) optionally, stoppering the product container; and (xiii) optionally, capping the product container.

Metadata:
- Claim Count in Document: 3.0
- Percentile: 100.0
- Lexical Diversity: 1.91304
- Patent Class: 424.0
- Transitional Phrase Type: open
- Component Type: 1
- Foreign Priority: False
- Related Applications: ['16355028', '16248460', '16373255', '14959651', '15703758']

Analysis Scores:
- 35 USC 101 Eligibility (BERT): 0.6469989618903134
- 35 USC 102 Novelty (BERT): 0.5011650156845375
- Combined Prediction Score: 0.6324155672697358
- Mean Citation Score: 196.58396800000003
- Max Citation Score: 220.09993
- Similarity Product: 144.88704412665368

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