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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/3/2025 has been entered.
Claims 121, 125, 127, 130, 134-136, 141-171 are pending.
The outstanding rejection under 35 USC 103a is withdrawn in view of the applicant’s arguments filed 12/3/2025 with regard to the unpredictability of fat-rich diet and the bioavailability of the instant compound.
The outstanding double patenting rejections over the conflicting patent application 17/782,362, 18/550,724, 18/838,781, 18/839, 147, and 18/978,431 are withdrawn in view of the applicant’s arguments filed 12/3/2025 with regard to the unpredictability of fat-rich diet and the bioavailability of the instant compound.
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 121, 125, 127, 130, 134-136, 141-144, 160-165 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11, 23, 35-38, 83-101 of copending Application No. 17/251,475 (‘475) (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘475 teaches the use of the same compound to treat PPD (see claim 11). ‘475 teaches the co-administration of food and the dosing regimen of the compound 1 (see claims 88, 96-98 for example). ‘475 teaches the reduction of HAM-D score (see claim 83).
‘475 reads on the herein claimed invention of claims 21, 125, 127, 130, 134-136, 141-144.
‘475 does not expressly teach the specific calories in the food.
It would have been obvious to one of ordinary skill in the art at the time of filing to adjust the calories of the food in the method of treating postpartum depression.
One of ordinary skill in the art would have been motivated to adjust the calories of the food in the method of treating postpartum depression. In a daily recommended diet of about 2000 – 3000 calories for adults, the calories taken along with the drug is considered about 1/3 of the daily intake. So in other words, it is almost equivalent to taking the medicine with one of three meals. Therefore, since taking the medicine with food is taught in ‘475, the calories intake would therefore, be reasonably expected to be met.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 145-159, 166-171 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAN MING R HUI whose telephone number is (571)272-0626. The examiner can normally be reached Mon - Fri 9:30-5:30.
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/SAN MING R HUI/Primary Examiner, Art Unit 1627