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 Claims
Claims 22-42 are pending.
Withdrawn rejections
Applicant's amendments and arguments filed 9/18/2025 are acknowledged and have been fully considered as convincing. Any rejection and/or objection not specifically addressed below is herein withdrawn.
Applicant states that a terminal disclaimer was filed, however, it has noted in the disclosure therefore the following NSDP rejection has been made of record.
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 22, 25, 26, 32, 35 and 36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,472,219 (herein ‘219) in view of Goskonda et al. (US 2019/0192428; published June 27, 2019). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending application discloses a method of making a cannabinoid composition for transdermal delivery and the present claim 22 also include a co-solvent in the water phase. It is for this reason that Goskonda et al. is joined.
Goskonda teaches oral cannabinoid formulations which are stable at room or refrigerated temperatures and may possess improved in vivo absorption profiles (abstract). The formulations include one or more co-solvents in an amount effective to substantially solubilize the cannabinoids and the amount of organic solvent can be varied based on the concentration of the cannabinoid [0054]. Goskonda teaches mixing/combining a cannabinoid, a non-ionic surfactant selected from polysorbate 80 (Tween 80) [0046], [0054] and [0059], a co-solvent selected from ethanol, propylene glycol, polyethylene glycol (PEG) or isopropanol [0031] and [0055], water [0004], [0005], [0054], a stabilizer [0061], and a thickening agent such xanthan gum [0073] and [0077]. One of ordinary skill in the art to would therefore obtain an oral cannabinoid composition by mixing the ingredients with the expectation that micelles would form that are capable of having increased bioavailability because Goskonda teaches that the cannabinoid formulations of the present invention improve the delivery of the cannabinoid with respect to extent, rate, and/or consistency of in vivo absorption from the location of administration [0088].
One of ordinary skill would have been motivated to combine the teachings ‘219 with Goskonda to include adding at least one co-solvent to the water phase because Goskonda teaches that adding one or more co-solvents selected from ethanol, propylene glycol, polyethylene glycol (PEG) and isopropanol aid in solubilizing the cannabinoids and non-ionic surfactants preferred include polysorbate 80. Therefore, the claims are prima facie obvious.
Claims 23, 24, 27-31, 33, 34 and 37-32 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIELLE D JOHNSON whose telephone number is (571)270-3285. The examiner can normally be reached Monday-Friday 9:00 am-5:30 pm.
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DANIELLE D. JOHNSON
Examiner
Art Unit 1617
/CRAIG D RICCI/Primary Examiner, Art Unit 1611
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