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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/1/2026 has been entered.
Claim Status
Claims 15-44 are pending.
Claims 1-14 are cancelled.
Claims 15-44 have been examined.
Priority
This application is a CON of 16/097,032 10/26/2018
16/097,032 is a 371 of PCT/EP2017/060160 04/28/2017, claiming foreign priority of EP 16167458.5 filed on 04/28/2016 and EP 16188262.6 filed on 09/12/2016.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7/1/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
New Ground of Rejection
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 15-18, 22-23, 25-27, 30, 34-36, and 39-43 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15, 18-23, 32, 34, 36-38, 40, and 42-44 of copending Application No. 19/735,096 (the ‘096 application, 7/8/2026). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘096 application disclosed a method obvious to the instant application.
Claim 15 of the ‘096 application disclosed a method for reducing the risk of a major adverse cardiovascular event (MACE) selected from cardiovascular (CV) death, non-fatal myocardial infarction (MI), and non-fatal stroke comprising subcutaneous injection of semaglutide to a patient once weekly and the patient has cardiovascular disease with clinical evidence of cardiovascular disease prior to treatment.
Claim 18 of the ‘096 application disclosed the administered semaglutide at a dosage of 0.1 mg to 3.0 mg.
Claim 32 of the ‘096 application disclosed the treated patient further comprising type 2 diabetes.
Thus, claims 15, 18, and 32 of the ‘096 application are obvious to the instant claims 15-16.
Claim 22 of the ‘096 application disclosed the clinical evidence of cardiovascular disease, satisfying the instant claim 17.
Claim 23 of the ‘096 application disclosed the clinical evidence of cardiovascular disease comprises renal impairment as documented by estimated glomerular filtration rate (eGFR) <60 mL/min/l.73m2 per equation eGFR-MDRD, satisfying the instant claim 18.
Claims 15, 19 and 32 of the ‘096 application disclosed the method comprises administering semaglutide once weekly by subcutaneous injection of 0.25 mg semaglutide, satisfying the instant claim 22.
Claims 15, 20 and 32 of the ‘096 application disclosed the method comprises administering semaglutide once weekly by subcutaneous injection of 0.5 mg semaglutide, satisfying the instant claim 23.
Claims 15, 20, 22-23 and 32 of the ‘096 application disclosed subject has clinical evidence of cardiovascular disease prior to treatment, satisfying the instant claims 25-27.
Claims 15, 21 and 32 of the ‘096 application disclosed the method comprises administering semaglutide once weekly by subcutaneous injection of 1 mg semaglutide, satisfying the instant claim 30.
Claims 15, 32, 34 and 36-37 of the ‘096 application disclosed a method of treating a subject with clinical evidence of cardiovascular disease prior to treatment, satisfying the instant claims 34-36.
Claims 15, 32, 38, 40, and 42 of the ‘096 application disclosed the method comprises administering 0.1 mg -5 mg of semaglutide once weekly by subcutaneous injection, satisfying the instant claims 39-40.
Claims 15, 32, 38, 40, 42, and 43-44 of the ‘096 application disclosed the subject has clinical evidence of cardiovascular disease prior to treatment, satisfying the instant claims 41-42.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 19-21, 24, 28-29, 31-33, 37-38, and 43-44 are objected to as being dependent upon a rejected base claim on the ground of nonstatutory double patenting, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
No claim is allowed.
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/J.L/Examiner, Art Unit 1658
24-July-2026
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
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