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 .
Applicant’s response filed on 3/9/2026 is acknowledged and fully considered.
Status of Application, Amendments, And/Or Claims
The amendments to claims 31 and 41, and the cancellation of claims 35-36 and 45-46 have been made of record.
Claims 31-34, 37-44 and 47-50 are pending and under examination.
Information Disclosure Statement
The Information Disclosure Statement (IDSs) filed on 12/16/2025 has been considered.
Response to Arguments
Claim Rejections - 35 USC § 103-withdrawn
The rejection of claim(s) 31-50 are rejected under 35 U.S.C. 103 as being unpatentable over Jensen et al. (US 2018/0235888) in view of Mantripragada et al. (US 2018/0271792) and Docherty et al. (US 2023/0301341, filed on 3/22/2022) is withdrawn in view of applicants’ amendments to claim 31 and 41, and the cancellation of claims 35-36 and 45-46.
Double Patenting-withdrawn
The rejection of claims 31-50 on the ground of nonstatutory double patenting as being unpatentable over claims 9-11 of U.S. Patent No. 12,397,042 is withdrawn in view of applicant’s filing of an electronic Terminal Disclaimer on 3/9/2026.
The rejection of claims 31-33, and 35-50 on the ground of nonstatutory double patenting as being unpatentable over claims 10-18 of U.S. Patent No. 12,472,236 is withdrawn in view of applicant’s filing of an electronic Terminal Disclaimer on 3/9/2026.
Double Patenting-maintain
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.
It is noted to applicants that the US Application 18/967,247 and 19/309,513 are copending applications which claims the priority to same provision applications: 63/605,701 filed on 12/4/2023; 63/617,759 filed on 1/4/2024 and 63/622,696 filed on 18/967,247 as the instant application.
Claims 31-34, 37-44 and 47-50 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/967,247 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because a composition for treating diabetes wherein the composition comprising: (a) from about 0.5% to about 20% by weight of one or more GLP-1 agonists; (b) from about 0.5% to about 40% by weight of one or more edible oils; (c) from about 1.5% to about 65% by weight of a bile salt extract; (d) from about 35% to about 65% by weight of sodium bicarbonate; and (e) from about 15% to about 85% by weight of one or more carriers, wherein the GLP-1 agonist is chosen from dulaglutide, exenatide, liraglutide, lixisenatide, semaglutide, and tirzepatide, or mixtures thereof, wherein the one or more edible oils is chosen from olive oil, sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, and peanut oil, or mixtures thereof, wherein the bile salt extract contains from about 45% to about 55% by weight of a bile salt selected from the group consisting of cholic acid, deoxycholic acid, taurocholate, and glycocholic acid, or a mixture thereof, and wherein the one or more carriers are chosen from sodium N-[8-(2-hydroxybenzoyl)amino]caprylate (SNAC), gum Arabic, inulin, mannitol, silicon dioxide, colloidal silicon dioxide, microcrystalline cellulose, D- lactose monohydrate, tapioca starch, tapioca flour, and quillaia, or mixtures thereof are taught by claims 1-20 of copending application No. 18/967,247. The only difference that the instant application is drawn for a method of treating type-2 diabetes which is well known in the art that GLP-1 agonists including liraglutide, semaglutide, tirzepatide, lixisenatide, exenatide treat diabetes and obesity.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 31-32, 35-42 and 45-50 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12-20 of copending Application No. 19,309,513 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because a method of treating type 2 diabetes comprising administering wherein the composition comprising: (a) from about 0.5% to about 20% by weight of one or more GLP-1 agonists; (b) from about 0.5% to about 40% by weight of one or more edible oils; (c) from about 1.5% to about 65% by weight of a bile salt extract; (d) from about 35% to about 65% by weight of sodium bicarbonate; and (e) from about 15% to about 85% by weight of one or more carriers, wherein the GLP-1 agonist is chosen from dulaglutide, exenatide, liraglutide, lixisenatide, semaglutide, and tirzepatide, or mixtures thereof, wherein the one or more edible oils is chosen from olive oil, sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, and peanut oil, or mixtures thereof, wherein the bile salt extract contains from about 45% to about 55% by weight of a bile salt selected from the group consisting of cholic acid, deoxycholic acid, taurocholate, and glycocholic acid, or a mixture thereof, and wherein the one or more carriers are chosen from sodium N-[8-(2-hydroxybenzoyl)amino]caprylate (SNAC), gum Arabic, inulin, mannitol, silicon dioxide, colloidal silicon dioxide, microcrystalline cellulose, D- lactose monohydrate, tapioca starch, tapioca flour, and quillaia, or mixtures thereof are taught by claims 12-20 of copending application No. 19/309,513.
Note: upon inventorship search update, the examiner found a new US Application No. 19/309,513 which is a CIP of US 18/967,259, now US Pat. No. 12,397,042. A new provisional double patenting rejection has been made over the new application No. 19/309, 513.
Claim Claims 31-34, 37-44 and 47-50 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-20 of copending Application No. 19/309,513 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because a method of treating type 2 diabetes comprising administering wherein the composition comprising: (a) from about 0.5% to about 20% by weight of one or more GLP-1 agonists; (b) from about 0.5% to about 40% by weight of one or more edible oils; (c) from about 1.5% to about 65% by weight of a bile salt extract; (d) from about 35% to about 65% by weight of sodium bicarbonate; and (e) from about 15% to about 85% by weight of one or more carriers, wherein the GLP-1 agonist is chosen from dulaglutide, exenatide, liraglutide, lixisenatide, semaglutide, and tirzepatide, or mixtures thereof, wherein the one or more edible oils is chosen from olive oil, sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, and peanut oil, or mixtures thereof, wherein the bile salt extract contains from about 45% to about 55% by weight of a bile salt selected from the group consisting of cholic acid, deoxycholic acid, taurocholate, and glycocholic acid, or a mixture thereof, and wherein the one or more carriers are chosen from sodium N-[8-(2-hydroxybenzoyl)amino]caprylate (SNAC), gum Arabic, inulin, mannitol, silicon dioxide, colloidal silicon dioxide, microcrystalline cellulose, D- lactose monohydrate, tapioca starch, tapioca flour, and quillaia, or mixtures thereof are taught by claims 1-20 of US Application No. 19/309,513.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicants argue that they will file a terminal disclaimer once other rejections are withdrawn and application is in condition for allowance.
Applicants’ arguments have been fully considered but they are not persuasive because the provisional rejection is made under a separate statute and therefore, the rejection is maintained.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GYAN CHANDRA whose telephone number is (571)272-2922. The examiner can normally be reached Mon-Friday 8:30AM-5:00P.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford can be reached at 571-272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GYAN CHANDRA/Primary Examiner, Art Unit 1674
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