PATENT CLAIM ANALYSIS

Application Number: 16030141
Application Type: Utility
Filing Date: 2018-07
Publication Date: 2019-03
Patent Classification: ["424", "499000"]

Abstract:
The disclosure relates to obeticholic acid formulations with improved stability, dissolution, and/or solubility, methods of preparing the same for use and methods of treating various diseases and conditions.

Claim (Index 56):
A method of treating nonalcoholic steatohepatitis (NASH) in a patient in need thereof, said method comprising administering a tablet comprising an intra-granular portion and an extra-granular portion, the intra-granular portion comprising obeticholic acid or a pharmaceutically acceptable salt, ester, or amino acid conjugate thereof in an amount of about 1 to about 50 mg, and one or more additional pharmaceutically acceptable excipients, and the extra-granular portion comprising one or more pharmaceutically acceptable excipients,\n wherein obeticholic acid or a pharmaceutically acceptable salt, ester, or amino acid conjugate thereof is in the form of particles, and wherein at least 50% of the particles have a diameter of 200 \u03bcm or less; wherein at least one pharmaceutically acceptable excipient having an alcohol content of less than about 6% (w/w); wherein the amount is a starting dose, an adjusted dose or a re-adjusted dose; and wherein the tablet can be administered daily (QD), every other day (Q2D), once a week (QW), twice a week (BID), three times a week (TIW), once a month (QM), or twice a month (Q2M).

Metadata:
- Claim Count in Document: 59.0
- Percentile: 95.0
- Lexical Diversity: 1.18519
- Patent Class: 424.0
- Transitional Phrase Type: open
- Component Type: 1
- Foreign Priority: False
- Related Applications: ['15139138', '13919734', '14947658', '14947680', '15496398']

Analysis Scores:
- 35 USC 101 Eligibility (BERT): 0.7290285000268543
- 35 USC 102 Novelty (BERT): 0.5930417006188985
- Combined Prediction Score: 0.7154298200860587
- Mean Citation Score: 342.533518
- Max Citation Score: 592.7554
- Similarity Product: 416.83053332812784

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

Dataset: test