PATENT CLAIM ANALYSIS

Application Number: 15956385
Application Type: Utility
Filing Date: 2018-04
Publication Date: 2018-10
Patent Classification: ["424", "499000"]

Abstract:
The disclosure provides a sustained release injectable neurosteroid formulation comprising neurosteroid particles having a D50 of less than 10 microns, the neurosteroid particles comprising a neurosteroid of Formula I: or a pharmaceutically acceptable salt thereof, wherein:   is a double or single bond and the variables, e.g., R 1 , R 2 , R 3 , R 4 , R 4a , R 5 , R 6 , R 7 , R 8 , R 9 , R 10 , and R 10a  are described herein. The formulation comprises neurosteroid particles comprising the neurosteroid and a polymeric surface stabilizer and provides an effective plasma concentration of the neurosteroid at steady state for at least 48 hours, and in some embodiments for at least 4 weeks. The sustained release injectable neurosteroid formulation can formulated for intramuscular or subcutaneous administration. The disclosure provides a method of treating a patient having seizures, anxiety, agitation, depression (including post-partum depression), schizophrenia, post-traumatic stress disorder, or tremors by administering the sustained release neurosteroid formulation to the patient. In certain embodiments the neurosteroid is ganaxolone.

Claim (Index 13):
The formulation of  claim 1 , wherein the formulation is an aqueous formulation comprising\n (a) neurosteroid particles having a D50 of 1 to 5 microns, the neurosteroid particles comprising ganaxolone, wherein the weight percent of the ganaxolone is 5 to 20%; (b) a polymeric surface stabilizer selected from hydroxy ethyl starch, dextran, and povidone, wherein the weight percent of the polymeric surface stabilizer is 2 to 50%; (c) an additional surface stabilizer wherein the additional surface stabilizer is an ionic or nonionic surfactant selected from sodium cholate, sodium deoxycholate, and sodium cholesterol sulfate, wherein the weight percent of surfactant is 0.1% to 2.0%; and (d) optionally, an antifoaming agent.

Metadata:
- Claim Count in Document: 50.0
- Percentile: 91.0
- Lexical Diversity: 2.0102
- Patent Class: 424.0
- Transitional Phrase Type: open
- Component Type: 1
- Foreign Priority: False
- Related Applications: ['15700314', '14772726', '11587906', '12041038', '12320539']

Analysis Scores:
- 35 USC 101 Eligibility (BERT): 0.6952791739660696
- 35 USC 102 Novelty (BERT): 0.5106897798393096
- Combined Prediction Score: 0.6768202345533937
- Mean Citation Score: 207.997362
- Max Citation Score: 269.98532
- Similarity Product: 177.01336995090958

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