PATENT CLAIM ANALYSIS

Application Number: 15760263
Application Type: Utility
Filing Date: 2018-03
Publication Date: 2018-09
Patent Classification: ["424", "201100"]

Abstract:
The present invention discloses a process for manufacturing a formulation comprising a drug substance, said drug substance comprising a recombinant  Listeria  comprising a human papilloma virus (HPV) antigen fused to a Listeriolysin O (LLO) protein fragment. The invention further discloses methods of using treating, protecting against, and inducing an immune response against cervical cancer comprising administration of the recombinant  Listeria  strain. The present invention also provides methods for inducing an anti-E7 CTL response in a human subject and treating HPV-mediated diseases, disorders, and symptoms, comprising administration of the recombinant  Listeria  strain.

Claim (Index 1):
A process for the manufacturing of a formulation comprising a drug substance, said drug substance comprising a recombinant  Listeria , said recombinant  Listeria  strain comprising a nucleic acid comprising an open reading frame encoding a recombinant polypeptide, said recombinant polypeptide comprising a human papilloma virus (HPV) antigen fused to a Listeriolysin O (LLO) polypeptide, the method comprising the steps of:\n a) Preparing fermentation media and adding said fermentation media into a fermenter system. i. wherein said preparing further comprises adding an antibiotic agent in solution.\n b) Adding a working cell bank (WCB) recombinant  Listeria  into said fermenter system. \n i. initiating the fermentation process until a target optical density (OD) of said drug substance is reached.\n c) Aseptically connecting said fermenter system to a filtration system and concentrating said drug substance to a desired weight by collecting a calculated amount of permeate. \n d) Obtaining a retentate solution comprising said drug substance from step c) and exchanging the fermentation media with an appropriate formulation for human use \n i. measuring the OD of said formulation buffer solution comprising said drug substance.\n e) Diluting said drug substance using said formulation buffer to a target OD, thereby forming a bulk drug substance (BDS). \n f) Transferring said BDS into intermediate product bags. \n i. aseptically filling vials with BDS from said product bags for storage or for drug preparation and administration to a subject.

Metadata:
- Claim Count in Document: 80.0
- Percentile: 90.0
- Lexical Diversity: 1.7931
- Patent Class: 424.0
- Transitional Phrase Type: open
- Component Type: 1
- Foreign Priority: False
- Related Applications: ['11715497', '13314583', '15306289', '11373528', '14883557']

Analysis Scores:
- 35 USC 101 Eligibility (BERT): 0.7815275531147782
- 35 USC 102 Novelty (BERT): 0.5763884718167182
- Combined Prediction Score: 0.7610136449849721
- Mean Citation Score: 486.261764
- Max Citation Score: 538.08765
- Similarity Product: 385.69473511760833

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

Dataset: test