DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 22, 23, 25-27, 30, 31, 33-36, and 38-46, submitted on 23 January 2026, represent all claims currently under consideration.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Priority
This application is a continuation of PCT/US2022/078202, filed 17 October 2022, which claims priority to provisional US 63/378,383, filed 5 October 2022 and provisional US 63/375,909, filed 16 September 2022. The effective filing date is 16 September 2022.
Information Disclosure Statement
Three Information Disclosure Statements (IDSs), submitted on 15 August 2024 and 26 January 2026 (2), are acknowledged and have been considered.
Double Patenting
Claims 22, 23, 25-27, 30, 31, 33-36, and 38-46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10, 12, and 15-18 of copending Application No. 19/538,314 (Amended Claims of 12 February 2026) (‘314).
Claim 10 of ‘314 claims a ready-to-drink vigabatrin liquid pharmaceutical composition comprising 10 wt% vigabatrin or a pharmaceutically acceptable salt thereof, 0.125 wt% methylparaben, 0.0125 wt% propylparaben, 0.25 wt% sucralose, and 0.003 wt% peppermint flavor, wherein the liquid pharmaceutical composition does not require reconstitution or dilution prior to administration to a patient and is stable up to at least six months at room temperature and refrigerated conditions. Claim 12 of ‘314 claims he composition of Claim 10 wherein the liquid pharmaceutical composition has total impurities of not more than 0.04% at or prior to six months. Claim 15 of ‘314 claims a method of treatment of a condition, comprising administering to a patient in need thereof a therapeutically effective amount of the ready-to-drink vigabatrin composition of Claim 10, wherein the condition is selected from the group consisting of refractory complex seizures, infantile spasms, and tuberous sclerosis, and wherein the patient is an adult patient or a pediatric patient. Claim 16 of ‘314 claims a method of treatment of a condition comprising administering to a patient in need thereof a therapeutically effective amount of the ready-to-drink vigabatrin liquid pharmaceutical composition of Claim 10 wherein the condition is refractory complex partial seizures and wherein the patient is an adult patient or a pediatric patient. Claim 17 of ‘314 is drawn to a method of the treatment of a condition, comprising administering to a patient in need thereof a therapeutically effective amount of the ready-to-drink vigabatrin liquid composition of Claim 10, wherein the condition is infantile spasms. Claim 18 is drawn to a method for the treatment of a condition, comprising administering to a patient in need thereof a therapeutically effective amount of the ready-to-drink vigabatrin liquid pharmaceutical composition of Claim 10, wherein the condition is tuberous sclerosis and wherein the patient is an adult patient or a pediatric patient.
The claims at issue are not identical but are not patentably distinct because the claims of ‘314 claim a method of treating the identical conditions as claimed in the examined application, using a composition of vigabatrin which has amounts of vigabatrin, preservative, flavoring agent, and sweetener which falls within the range of what is claimed in the examined application, and thus is prima facie obvious due to the overlapping range (See MPEP § 2144.05 I). This formulation also has the same stability properties as those claimed in the examined application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Relevant Close Art
Nagar (WO 2019/186515; Publication Date: 3 October 2019) (See IDS, 15 August 2024) discloses a ready- to-drink liquid pharmaceutical composition (page 5, line 3, ready to use, liquid compositions of an antiepileptic drug; page 36, lines 1-2, a liquid composition comprising Vigabatrin or its pharmaceutically acceptable salts) comprising vigabatrin, or a pharmaceutically acceptable salt thereof (page 36, lines 1-2, a liquid composition comprising Vigabatrin or its pharmaceutically acceptable salts), in the range from about 0.1 wt % to about 20 wt % (page 36, lines 1-2, a liquid composition comprising Vigabatrin or its pharmaceutically acceptable salts; page 32, Table-1, Active pharmaceutical ingredient (antiepileptic drug) 0.01-25% w/v); at least one preservative in the range from about 0.001 to about 1.0 wt%; at least one sweetening agent in the range from about 0.05 wt% to about 40.0 wt%; at least one flavoring agent in the range from about 0.001 wt% to about 10.0 wt%; and quantum satis (q.s.) purified water (page 5, lines 18-25, The solution dosage forms according to the present invention comprises an antiepileptic drug or pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients or additives selected from the group comprising of vehicles, solvents/co-solvents, solubilizers, surfactants, pH adjusting agents and/or pH modifying agents and/or buffering agents or any combination thereof. The solution dosage forms according to the present invention may further comprise one or more agents selected from the group comprising of preservatives, sweetening agents, flavoring agents and coloring agents or any combination thereof; page 21, line 10, Vehicles may be aqueous; page 32, Table-1, Preservative(s) 0.01-10%; Sweetening agent(s) 0.01-5%; Flavoring agent(s) 0.01-5%; Vehicle Q.S.; also see Processes 1-5 at pages 32-34 suggesting dosage forms comprising preservative and/or sweetening agent and/or flavoring agent); wherein the pharmaceutical composition (i) is a ready to use premixture that does not require reconstitution or dilution prior to administration to a patient (page 5, line 3, ready to use, liquid compositions of an antiepileptic drug; page 7, lines 5-8, method for the treatment of epilepsy and/or convulsion and/or seizure and/or a disease or a condition that can be treated by antiepileptic drugs comprising administering to a patient, such as human, an effective dosage amount of a liquid pharmaceutical composition); and (ii) is stable for at least six months at room temperature or refrigerated conditions (page 17, lines 27-33, the term “storage conditions” as used herein without limitation include typical storage conditions such as 2°C-8°C, 40°C+-2°C/754+-5 9RH, 30°C+-2°C/65+-%RH, 25°C +-2°C/404+-59RH, i-e., at room temperature, ...the liquid pharmaceutical compositions of the present invention are stable for at least 1 month, at least 3 months, at least 6 months or at least 12 months when stored under storage conditions). However, Nagar does not fairly teach or suggest the a method of treating the claimed conditions using a vigabatrin composition wherein the composition consists of the particular combination of vigabatrin, preservative, sweetening agent, flavoring agent, and water in the amounts as claimed (Page 32, Table-1, pages 32-34, which suggests compositions comprising other excipients in addition to preservative, sweetening agent, and flavoring agent), and wherein such a combination results in a composition which is stable for at least six months at room temperature or refrigerated conditions, and wherein the total impurities are not more than 0.04%. Additionally, Applicant’s data in the specification as filed demonstrates the criticality of the particular combination of excipients claimed (i.e., preservative, sweetening agent, and flavoring agent, in amounts claimed, which are free of buffering agents, antioxidants, and solubilizers) to obtain the instantly claimed properties of stability along with the lower amount of impurities.
Conclusion
Claims 22, 23, 25-27, 30, 31, 33-36, and 38-46 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP MATTHEW RZECZYCKI whose telephone number is (703)756-5326. The examiner can normally be reached Monday Thru Friday 730AM-5PM EST.
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/P.M.R./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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