DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 17 December 2025 has been entered.
3. Applicant's arguments and amendments to the claims presented in the reply of 17 December 2025 have been fully considered but do not place the application in condition for allowance. All rejections not reiterated herein are hereby withdrawn.
Claim Status
4. Claims 54, 55, 59 and 60 are pending and have been examined herein. The claims have been examined to the extent that they read on the elected species of the variant of 5:96394941:G:A and the elected MC4R agonist of setmelanotide. The claims encompass the non-elected species of methods in which the PCSK1 variant genomic nucleic acid is one of the variants listed in claim 54 other than 5:96394941:G:A and claims 54, and 59-60 encompass non-elected MC4R agonists. Prior to the allowance of claims, any non-elected subject matter which has not been rejoined with the elected subject matter will be required to be removed from the claims.
Claim Interpretation
5. The claims recite “the subject is heterozygous for a proprotein convertase subtilisin/kexin type 1 (PCSK1) variant genomic nucleic acid molecule associated with an increased risk of developing obesity and/or elevated BMI…wherein the PCSK1 variant genomic nucleic acid molecule comprises 5:96393172:A:C…”. In the reply of 17 December 2025, Applicant states “Applicant's specification provides ample guidance for determining whether any particular subject is heterozygous for one of the specific PCSK1 variant genomic nucleic acid molecules recited in claim 54.” It is argued that “a subject may have had a genotype performed prior to being treated with the MC4R agonist.” Consistent with Applicant’s arguments, the claims have been interpreted as requiring that the subject is one in which it has been determined that the subject has the PCSK1 variant genomic nucleic acid molecule prior to performing the administering step. The claims are considered to exclude methods wherein the recited MC4R agonist, and particularly setmelanotide, is administered to a subject that is not known to have one of the listed PCSK1 variant genomic nucleic acid molecules. For example, Kuhnen et al (N Engl J Med. 2016. 375: 240-246; cited in the IDS of 09/04/2024) teaches “Setmelanotide, an eight-amino-acid cyclic peptide also known as RM-493, is a melanocortin-4 receptor agonist (50% effective concentration [EC50], 0.27 nM). Setmelanotide has been administered to more than 200 obese patients who were not known to have genetic defects” (p. 241, col. 1). The claimed method does not read on the method of Kuhnen because Kuhnen does not teach administering setmelanotide to obese subjects known to have / previously determined to have one of the listed PCSK1 variant genomic nucleic acid molecules.
Maintained Rejection - Double Patenting
6. 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 54, 55, 59 and 60 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 12,049,670 (previously cited). Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims and the claims of ‘670 are both inclusive of methods of treating a subject having obesity and/or elevated body mass index (BMI), wherein the subject is heterozygous for a proprotein convertase subtilisin/kexin type 1 (PCSK1) variant genomic nucleic acid molecule associated with an increased risk of developing obesity and/or elevated BMI, the method comprising: administering an MC4R agonist to a subject that has been determined to be heterozygous for the PCSK1 variant genomic nucleic acid molecule associated with an increased risk of developing obesity and/or elevated BMI, wherein the PCSK1 variant genomic nucleic acid molecule is 5:96394941:G:A, and wherein the MC4R agonist is setmelanotide. Note that the present claims recite the open claim language of comprising and thereby may include additional steps, such as the step of “detecting the presence of a PCSK1 variant genomic nucleic acid molecule associated with an increased risk of developing obesity and/or elevated BMI in a biological sample from the subject” recited in claim 1 of ‘670. Response to Remarks:
The response states: “Applicant intends to file a Terminal Disclaimer upon an indication of allowable claims in the present application.”
It is noted that a terminal disclaimer has not been filed and Applicant did not otherwise traverse the nonstatutory double patenting rejection. The rejection is maintained for the reasons set forth above.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARLA J MYERS whose telephone number is (571)272-0747. The examiner can normally be reached M-Th 6:30-5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu-Cheng (Winston) Shen can be reached on 571-272-0731. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CARLA J MYERS/Primary Examiner, Art Unit 1682
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