DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on August 15, 2025 has been entered.
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 .
Priority
This Application filed on 05/30/2024 is a continuation of 18/648,049 filed on 04/26/2024, which is a continuation of 17/449,785 filed on 10/01/2021 which is a continuation of PAT 11135214 filed on 05/13/2019 , which has a PRO 62/670,253 filed on 05/11/2018.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed on 8/15/25 is in compliance with the provisions of S7 CFR 1.97. Accordingly, the IDS is being considered by the Examiner.
Response to Arguments
The rejection of claims 117-120, 125, 130, 134-139, 143-144, and 146-149 under 35 U.S.C. 102(a)(1) as being unpatentable over Vernier et al. ( US20110003850 A1) is persuasive. The rejection is herewith modified.
The rejection of claims 121, 126-128, 131-133, and 140 under 35 U.S.C. 103(a) as being unpatentable over Vernier et al. ( US20110003850 A1) is not persuasive. The rejection is herewith maintained.
The rejection of claims 122-123 and 141-142 under 35 U.S.C. 103(a) as being unpatentable over Vernier et al. ( US20110003850 A1), as applied to as applied to claims 117-121, 125-128, 130-140, 143-144, and 146-149 above in view Johannessen et al. (Management of Focal-Onset Seizures. Qrugs, 2006, Volume 66, Number 13, Page 1704) depends on the validity of the previous arguments which were not found persuasive.. The rejection is herewith maintained.
Applicant argues “the presently pending claims relate to the administration of Compound A via a method that does not comprise dose titration.” The Examiner states similarly Vernier does not require dose titration, as the reference does not teach or specify titrating the formulation. The Examiner points out that the reference only discusses daily administering compound A: amount of from about 10 mg to about 2000 mg per day to a patient and does not refer to titration. If the prior art refers to administering compound A:
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in an amount of from about 10 mg to about 2000 mg per day to a patient [0337] and does not describe titrating the formulation. Therefore, the prior art renders obvious the claimed limitation “does not comprise dose titration.” Applicant’s arguments are not persuasive.
Applicant’s state that the provisional ODP rejection be held in abeyance until patentable subject matter is determined. The rejection is herewith maintained.
ODP rejection U.S. Applic. No. 17449785 is withdrawn in view of abandonment of claims and ODP rejection over provisional U.S. Applic. No. 18/248, 661 is withdrawn in view of arguments.
The following rejections are made:
Claim Rejections - 35 USC § 103
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 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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 117-128, 130-140, 143-144, and 146-149 are rejected under 35 U.S.C. 103 as being unpatentable over Vernier et al. ( US20110003850 A1).
Vernier et al. teaches a method of treating or preventing a disease, disorder, or condition that is affected by modulation of at least one potassium ion channel selected from KCNQ2/3, KCNQ4, and KCNQ5, such as treating or preventing a seizure disorder in a patient comprising administering compound A:
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in an amount of from about 10 mg to about 2000 mg per day to a patient. [0337] Tests examples show oral administration of the compound. [0529]. The prior art does not require titration.
Vernier et al. teaches daily administration of the formulation and a range of about 10 mg to about 2000 mg per day of the compound but does not specify 6 days, or the specific amount of 15 mg, 20 mg, 25 mg, as claimed.
It would have been obvious to one of ordinary skill in the art at the time of filing to treat the patient within the dosage range. The motivation to treat the patient for 6 days, at a dosage of 15 mg, 20 mg, 25 mg is because Vernier et al. teaches administering compound A in an amount of from about 10 mg to about 2000 mg per day which results in treating or preventing a disease, disorder, or condition that is affected by modulation of at least one potassium ion channel selected from KCNQ2/3, KCNQ4, and KCNQ5, such as a seizure disorder. Hence, a skilled artisan would have had reasonable expectation of successfully achieving similar results.
Claims 122-123 and 141-142 are rejected under 35 U.S.C. 103 as being unpatentable over Vernier et al. ( US20110003850 A1), as applied to as applied to claims 117-121, 125-128, 130-140, 143-144, and 146-149 above in view Johannessen et al. (Management of Focal-Onset Seizures. Qrugs, 2006, Volume 66, Number 13, Page 1704}.
Vernier et al. fail to specify seizure focal onset.
Johannessen et al. teaches focal onset selzures are manifestations of abnormal epileptic firing of brain cells in a localized area or areas of the brain.
It would have been obvious to one of ordinary skill in the art at the time of the invention to treat focal onset seizures. The motivation comes from the general teaching that compound A is useful in treatment of seizure disorders. Hence, a skilled artisan would have reasonable expectation of successfully achieving similar efficacy and results.
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 117-123, 125-1128, 130-144 and 146-149 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 117, 119-123, 126-136, 139-144 and 145-151 of U.S. Applic. No. 18/648,049. Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims are drawn to a method of orally administering Compound A to a human in need thereof, wherein Compound A is N-[4-(6-fluoro-3,4-dihydro- 1 H-isoquinolin-2-yl)-2,6- dimethylphenyl]-3,3-dimethylbutanamide; the improvement comprising orally administering an amount of Compound A to the human under fed conditions while the claims herein are drawn to a method of administering Compound A to a human in need thereof; wherein Compound A is N-[4-(6-fluoro-3,4-dihydro- 1 H-isoquinolin-2-yl)-2,6-dimethylpheny1]-3,3- dimethylbutanamide; the improvement comprising administering Compound A to the human without dose titration.
Claims 117-123, 125-1128, 130-144 and 146-149 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 19-34 of U.S. PAT. No. 11957675. Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims are drawn to a Method of treating anhedonia, comprising administering a therapeutically effective amount of Compound A to a human in need thereof; wherein Compound A is N-[4-(6-fluoro-3,4-dihydro-1H-isoquinolin-2-yl)-2,6-dimethylphenyl]-3,3-dimethylbutanamide, wherein Compound A is orally administered to the human from between about 30 minutes before to about 2 hours after eating a meal and Compound A is administered at a dose of 5-150 mg per day to the human , while the claims herein are drawn a method of administering Compound A to a human in need thereof; wherein Compound A is N-[4-(6-fluoro-3,4-dihydro- 1 H-isoquinolin-2-yl)-2,6-dimethylpheny1]-3,3- dimethylbutanamide; the improvement comprising administering Compound A to the human without dose titration.
Claims 117-123, 125-1128, 130-144 and 146-149 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 11135214. Although the claims at issue are not identical, they are not patentably distinct from each other because the US Patented claims are drawn to a method of orally administering Compound A to a human in need thereof, wherein Compound A is N-[4-(6-fluoro-3,4-dihydro-1H- isoquinolin-2-yl)-2,6-dimethylphenyl]-3 ,3-dimethyloutanamide; wherein the improvement comprises orally administering an amount of Compound A to the human from between 30 minutes prior to consuming food until 2 hours after consuming food while the claims herein are drawn a method of administering Compound A to a human in need thereof; wherein Compound A is N-[4-(6-fluoro-3,4-dihydro- 1 H-isoquinolin-2-yl)-2,6-dimethylpheny1]-3,3- dimethylbutanamide; the improvement comprising administering Compound A to the human without dose titration. The claims are rendered obvious.
Claims 117-123, 125-1128, 130-144 and 146-149 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20-22 of U.S. Patent No. 11091441B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the US Patented claims are drawn to method of preparing the pharmaceutical composition of claim 7, the method comprising combining the crystalline form of Compound A with the pharmaceutical excipient, carrier, and/or diluent to form the pharmaceutical composition wherein the crystalline form is administered to the human from between 30 minutes before to 2 hours after eating a meal while the claims herein are drawn to a method of administering Compound A to a human in need thereof; wherein Compound A is N-[4-(6-fluoro-3,4-dihydro- 1 H-isoquinolin-2-yl)-2,6-dimethylpheny1]-3,3- dimethylbutanamide; the improvement comprising administering Compound A to the human without dose titration. The claims are rendered obvious.
Claims 117-123, 125-1128, 130-144 and 146-149 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-116 of U.S. Applic. No. 19008882 – provided in the IDS filed on 3/12/25. Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims are drawn to a method of treating a seizure disorder in a human in need thereof, comprising orally admunistering an amount of Compound A to the human under fed conditions; wherein Compound A is V-[4-(6-fluoro-3,4-diby dro- 1 A-isoquinolin-2-yD-2,6- dimethyiphenyl-3,3-dimethylbutanamide: and wherein the amount of Compound A is from 2 to 200 mg while the claims herein are drawn to a method of administering Compound A to a human in need thereof; wherein Compound A is N-[4-(6-fluoro-3,4-dihydro- 1 H-isoquinolin-2-yl)-2,6-dimethylpheny1]-3,3- dimethylbutanamide; the improvement comprising administering Compound A to the human without dose titration.
Conclusion
Correspondence
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/LAYLA SOROUSH/ Primary Examiner, Art Unit 1622