PATENT CLAIM ANALYSIS

Application Number: 16215318
Application Type: Utility
Filing Date: 2018-12
Publication Date: 2019-08
Patent Classification: ["424", "468000"]

Abstract:
Sustained release oral dosage forms of a gabapentin prodrug, 1-{[α-isobutanoyloxyethoxy)carbonyl]aminomethyl}-1-cyclohexane acetic acid, are disclosed. The dosage forms are useful for treating or preventing diseases and disorders for which gabapentin is therapeutically effective.

Claim (Index 36):
A method of treating insomnia in a patient, comprising administering to the patient in need of such treatment one or more sustained release oral tablets comprising:\n (a) 10 wt % to 65 wt % of 1-{[\u03b1-isobutanoyloxyethoxy)carbonyl]aminomethyl}-1-cyclohexane acetic acid; (b) 30 wt % to 50 wt % dibasic calcium phosphate; (c) 1 wt % to 50% of a release rate-modifying polymer; wherein wt % is based on the total dry weight of the dosage form, which one or more tablets: when administered to one or more fasted human patients in need of a method of treating insomnia at a dose of 1-{[\u03b1-isobutanoyloxyethoxy)carbonyl]aminomethyl}-1-cyclohexane acetic acid ranging from about 1100 mg to about 1300 mg provides a gabapentin plasma concentration profile characterized by a C max  ranging from about 3 \u03bcg/mL to about 6 \u03bcg/mL, a T max  ranging from about 4 hours to about 7 hours, and a AUC ranging from about 30 \u03bcg\u00b7hr/mL to about 70 \u03bcg\u00b7hr/mL; or when administered to one or more fed human patients in need of a method of treating insomnia at a dose of 1-{[\u03b1-isobutanoyloxyethoxy)carbonyl]aminomethyl}-1-cyclohexane acetic acid ranging from about 1100 mg to about 1300 mg provides a gabapentin plasma concentration profile characterized by a C max  ranging from about 5 \u03bcg/mL to about 8 \u03bcg/mL, a T max  ranging from about 6 hours to about 11 hours, and a AUC ranging from about 60 \u03bcg\u00b7hr/mL to about 110 \u03bcg\u00b7hr/mL.

Metadata:
- Claim Count in Document: 5.0
- Percentile: 98.0
- Lexical Diversity: 1.18421
- Patent Class: 424.0
- Transitional Phrase Type: open
- Component Type: 1
- Foreign Priority: False
- Related Applications: ['14309662', '11269045', '15359321', '13164620', '14206893']

Analysis Scores:
- 35 USC 101 Eligibility (BERT): 0.7601954581152327
- 35 USC 102 Novelty (BERT): 0.6250768726890101
- Combined Prediction Score: 0.7466835995726104
- Mean Citation Score: 496.648788
- Max Citation Score: 623.77496
- Similarity Product: 505.9296711471844

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