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 .
Status of the Claims
Claims 236-251 are pending. Claims 236-251 are rejected.
Priority
This application is a CON of 16/786,160 filed 02/10/2020 PAT 12083131. 16/786,160 is a CON of 15/509,656 filed 03/08/2017 (abandoned). 15/509,656 is a 371 of PCT/US15/48937 filed 09/08/2015. PCT/US15/48937 has PRO 62/213,015 filed 09/01/2015, PRO 62/170,596 filed 06/03/2015, and PRO 62/047,599 filed 09/08/2014.
Information Disclosure Statement
The information disclosure statement(s) (IDS) dated 03/18/2025 has/have been considered.
Non-Statutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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(1 of 2) Claims 236-251 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,083,131. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are drawn to a method for treating postpartum depression comprising a continuous intravenous infusion of allopregnanolone that are nearly identical to those of the pending claims.
Claim 1 in US ‘131 recites that the infusion comprises first, second and third infusions wherein the first infusion is administered at a continuously increasing amount and wherein the third infusion is administered at a continuously decreasing amount. While instant claim 236 does not have the same requirement, patented claim 1 is fully embraced by instant claim 236 since the present claim does not specify whether the individual infusions are increasing, decreasing, or constant. Moreover, the limitations further imposed in patented claims 2-16 are identical to those of instant claims 237-251. Thus, the claims are obvious in view of the patented claims.
(2 of 2) Claims 236-251 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10,940,156, and further in view of Reddy in WO 2013/112605, as cited in IDS dated 04/27/2020 of parent application 16/786,160. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are drawn to a method for treating postpartum depression comprising a continuous infusion of allopregnanolone via a dosing regimen that increases then decreases over a 60 hour time period. The patented claims are also directed to co-administration of the allopregnanolone with sulfobutylether-β-cyclodextrin (see claim 2) and different concentrations of allopregnanolone and volume by weight of the cyclodextrin. The patented claims do not explicitly teach an infusion regimen wherein there is a first, second and third infusion and the second infusion dosage per unit time is higher than that of the first and third dosages.
It would have been obvious to one skilled in the art to administer a continuous infusion of allopregnanolone wherein the infusion comprises administering a first infusion, second infusion, and third infusion to the subject, and wherein the first infusion delivers a smaller amount, as measured in µg/kg/hour, of allopregnanolone/unit time than the second infusion, and wherein the third infusion delivers a smaller amount, as measured in µg/kg/hour, of allopregnanolone /unit time than the second infusion because the optimization of result effect parameters e.g., dosage range, dosing regimens, dosing duration is obvious as being within the skill of the artisan, involving merely routine skill in the art.
Moreover, patented claim 1 is nearly embraced by instant claims 236-242 and 251 wherein the patented
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dose represents the increasing first infusion of the instant claims, the patented
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dose represents the constant second dose of the instant claims, and the patented
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dose represents the decreasing third infusion of the instant claims; all carried out over a period of 60 hours per instant claim 251.
While the patented claims do not teach a “plurality of step doses” for any dosing regimen, it would have been obvious to a person having ordinary skill in the art to administer a continuous infusion of allopregnanolone wherein the first infusion comprises plurality of step doses as in instant claim 237; wherein the third infusion comprises plurality of step doses as in claim 238 because the optimization of result effect parameters e.g., dosage range, dosing regimens, dosing duration is obvious as being within the skill of the artisan, involving merely routine skill in the art. Thus, claims 236-242 and 251 are obvious in view of the patented claims.
Regarding instant claims 243-245 drawn to the method of claim 236 wherein the allopregnanolone is provided in a composition comprising cyclodextrin, patented claims 2 and 7-8 recite an aqueous solution of allopregnanolone and sulfobutylether-β-cyclodextrin wherein the solution comprises about 1% to about 30% (per claim 7) or about 1% to about 15% (per claim 8) by weight of sulfobutylether-β-cyclodextrin per volume of aqueous solution. Thus, claims 243-245 are obvious in view of the patented claims.
Regarding instant claims 246 and 247 drawn to the method of claim 236 wherein the allopregnanolone is provided at a concentration of 0.1 to 10 mg/mL or 1 to 5 mg/mL, patented claims 4 and 5 are drawn to a sterile composition with the same concentration ranges for allopregnanolone. Thus, claims 246 and 247 are obvious in view of the patented claims.
Regarding instant claims 248-250, it would have been obvious to a person of ordinary skill in the art at the time of invention to determine or optimize parameters such as effective amounts of allopregnanolone, and cyclodextrin, e.g., a β-cyclodextrin, e.g., a sulfo butyl ether β-cyclodextrin, to obtain a pharmaceutical composition. The skilled artisan would have been motivated to determine the effective amounts of allopregnanolone, and cyclodextrin employed in the compositions, since the optimization of effective amounts of known agents to be administered, is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art.
Reddy in WO ‘605 teaches several formulations comprising allopregnanolone and a cyclodextrin (preferably CAPTISOL®) used for intramuscular, subcutaneous or intravenous administration. Formulations comprising a neuroactive steroid, e.g., allopregnanolone; and optionally a cyclodextrin, e.g., a β-cyclodextrin, e.g., a sulfo butyl ether β-cyclodextrin, e.g., CAPTISOL.RTM. and methods of use in treating CNS disorders. See abstract. It is taught that the neuroactive steroid, e.g., allopregnanolone, and cyclodextrin, e.g., a β-cyclodextrin, e.g., a sulfo butyl ether β-cyclodextrin, e.g., CAPTISOL.RTM., complex is formulated as an aqueous composition comprising the neuroactive steroid, e.g., allopregnanolone, at a concentration is 1.5 mg/mL (see claim 24), and the cyclodextrin, e.g., a β-cyclodextrin, e.g., a sulfo butyl ether β-cyclodextrin, e.g., CAPTISOL.RTM., at a concentration of 6%, 15%, or 30% (see claims 26-28). Reddy teaches treating traumatic brain injury comprising administering the formulation allopregnanolone and a cyclodextrin. See abstract. Reddy teaches various dosage regimens first, second or third dose or infusions. See pages 34, page 35, line 9; pages 49-51. Reddy teaches that the formulation therein are sterile and can contain buffers such as citrate buffers. See page 85, lines 28-30; page 86.
The skilled artisan would have had a reasonable expectation of success in using a 1.5 mg/mL concentration of allopregnanolone in a formulation with 6% to 30% sulfobutylether-β-cyclodextrin since Reddy teaches such formulations and their administration in mice. See for instance Examples 4-6 on pages 112-113. Thus, instant claims 248-250 are obvious in view of the patented claims.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jalisa H. Ferguson whose telephone number is (703)756-1489. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm.
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/J.H.F./Examiner, Art Unit 1626
/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626
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