DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Amendments after Non-final office action filed on 12/1/2025 and 12/18/2025 are acknowledged.
3. Claim filed on 12/18/2025 is acknowledged.
4. Claims 3, 6-13, 15, 16, 20-25, 29, 31-35, 37-42, 44, 45, 47-49, 52, 53, 56-66 and 69 have been cancelled.
5. Claims 1, 2, 4, 5, 14, 17-19, 26-28, 30, 36, 43, 46, 50, 51, 54, 55, 67 and 68 are pending in this application.
6. Applicant elected with traverse of compound 1 with the structure
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as species of polypeptide or a pharmaceutically acceptable salt thereof; type 2 diabetes as species of disease; and the administration scheme of separately as species of administration scheme in the reply filed on 5/7/2025.
Restriction requirement was deemed proper and made FINAL in the previous office action. The instant claims 1, 2, 4, 5, 14, 17-19, 26-28, 30, 36, 43, 46, 50, 51, 54, 55, 67 and 68 are drawn to a polypeptide comprising the amino acid sequence of SEQ ID NO: 1, wherein at least one of X3 and X5 is Lys; and with the proviso that when X1 is Aib, X2 is not Aib; and wherein the acid group of the C terminal amino acid is a free carboxylic acid group or is amidated as a C-terminal primary amide, or a pharmaceutically acceptable salt thereof; a pharmaceutical composition comprising such polypeptide or a pharmaceutically acceptable salt thereof and one or more of pharmaceutically acceptable excipients; a polypeptide selected from the group consisting of compounds 1-12 or a pharmaceutically acceptable salt thereof; and a method of treating hyperglycemia, type 2 diabetes, impaired glucose tolerance, type 1 diabetes, obesity, hypertension, hyperlipidemia, syndrome X, dyslipidemia, cognitive disorders, atherosclerosis, myocardial infarction, coronary heart disease, stroke, inflammatory bowel syndrome, dyspepsia, alcoholism, or gastric ulcers in a patient in need thereof, wherein the method comprises administering to the patient a therapeutically effective amount of the polypeptide or pharmaceutically acceptable salt thereof according to claim 1. A search was conducted on the elected species; and these appear to be free of prior art. A search was extended to the genus in claims 1, 54 and 67; and these too appear to be free of prior art. Claims 1, 2, 4, 5, 14, 17-19, 26-28, 30, 36, 43, 46, 50, 51, 54, 55, 67 and 68 are examined on the merits in this office action.
Withdrawn Objections and Rejections
7. Objection to the specification is hereby withdrawn in view of Applicant’s amendment to the specification.
8. Objection to claims 1, 2, 4, 5, 14, 17-19, 26-28, 30, 36, 43, 46, 50, 51, 54, 55, 67 and 68 is hereby withdrawn in view of Applicant’s amendment to the claim.
9. Rejection to claims 19, 28 and 30 under 35 U.S.C. 112(d) or 35 U.S.C. 112 (pre-AIA ), 4th paragraph is hereby withdrawn in view of Applicant’s amendment to the claim.
10. Rejection to claims 67 and 68 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph (scope of enablement) is hereby withdrawn in view of Applicant’s amendment to the claim.
Maintained Rejections
Obviousness Double Patenting
11. 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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
12. Claims 1, 2, 4, 5, 14, 17-19, 26-28, 30, 36, 43, 46, 50, 51, 54 and 55 remain provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-24 of co-pending Application No. 18812797.
13. Instant claims 1, 2, 4, 5, 14, 17-19, 26-28, 30, 36, 43, 46, 50, 51, 54, and 55 are drawn to a polypeptide comprising the amino acid sequence of SEQ ID NO: 1, wherein at least one of X3 and X5 is Lys; and with the proviso that when X1 is Aib, X2 is not Aib; and wherein the acid group of the C terminal amino acid is a free carboxylic acid group or is amidated as a C-terminal primary amide, or a pharmaceutically acceptable salt thereof; a pharmaceutical composition comprising such polypeptide or a pharmaceutically acceptable salt thereof and one or more of pharmaceutically acceptable excipients; and a polypeptide selected from the group consisting of compounds 1-12 or a pharmaceutically acceptable salt thereof.
14. Claims 1-24 of co-pending Application No. 18812797 are drawn to a polypeptide or a pharmaceutically acceptable salt thereof comprising an amino acid sequence of SEQ ID NO: 3, wherein the acid group of the C-terminal amino acid is a free carboxylic acid group or is amidated as a C-terminal primary amide; a pharmaceutical composition comprising such polypeptide or the pharmaceutically acceptable salt thereof and one or more of pharmaceutically acceptable excipient; and a polypeptide or a pharmaceutically acceptable salt thereof selected from the group consisting of compounds 1, 3, 4 and 7.
Claims 1-24 of co-pending Application No. 18812797 recite either a subgenus of instant claimed polypeptide or a pharmaceutically acceptable salt thereof or species of polypeptide or a pharmaceutically acceptable salt thereof that is within the scope of instant claimed polypeptide or a pharmaceutically acceptable salt thereof.
This is a provisional obviousness-type double patenting rejections because the conflicting claims have not in fact been patented.
15. Claims 1, 2, 4, 5, 14, 17-19, 26-28, 30, 36, 43, 46, 50, 51, 54, 55, 67 and 68 remain provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-24 of co-pending Application No. 18812797 in view of Coskun et al (Molecular Metabolism, 2018, 18, pages 3-14, filed with IDS) and Marín-Peñalver et al (World J Diabetes, 2016, 7, pages 354-395, cited and enclosed in the previous office action).
16. Instant claims 1, 2, 4, 5, 14, 17-19, 26-28, 30, 36, 43, 46, 50, 51, 54, 55, 67 and 68 are drawn to a polypeptide comprising the amino acid sequence of SEQ ID NO: 1, wherein at least one of X3 and X5 is Lys; and with the proviso that when X1 is Aib, X2 is not Aib; and wherein the acid group of the C terminal amino acid is a free carboxylic acid group or is amidated as a C-terminal primary amide, or a pharmaceutically acceptable salt thereof; a pharmaceutical composition comprising such polypeptide or a pharmaceutically acceptable salt thereof and one or more of pharmaceutically acceptable excipients; a polypeptide selected from the group consisting of compounds 1-12 or a pharmaceutically acceptable salt thereof; and a method of treating hyperglycemia, type 2 diabetes, impaired glucose tolerance, type 1 diabetes, obesity, hypertension, hyperlipidemia, syndrome X, dyslipidemia, cognitive disorders, atherosclerosis, myocardial infarction, coronary heart disease, stroke, inflammatory bowel syndrome, dyspepsia, alcoholism, or gastric ulcers in a patient in need thereof, wherein the method comprises administering to the patient a therapeutically effective amount of the polypeptide or pharmaceutically acceptable salt thereof according to claim 1.
17. Claims 1-24 of co-pending Application No. 18812797 are drawn to a polypeptide or a pharmaceutically acceptable salt thereof comprising an amino acid sequence of SEQ ID NO: 3, wherein the acid group of the C-terminal amino acid is a free carboxylic acid group or is amidated as a C-terminal primary amide; a pharmaceutical composition comprising such polypeptide or the pharmaceutically acceptable salt thereof and one or more of pharmaceutically acceptable excipient; and a polypeptide or a pharmaceutically acceptable salt thereof selected from the group consisting of compounds 1, 3, 4 and 7.
Claims 1-24 of co-pending Application No. 18812797 recite either a subgenus of instant claimed polypeptide or a pharmaceutically acceptable salt thereof or species of polypeptide or a pharmaceutically acceptable salt thereof that is within the scope of instant claimed polypeptide or a pharmaceutically acceptable salt thereof.
Furthermore, as evidenced by the specification of co-pending Application No. 18812797, the polypeptide or a pharmaceutically acceptable salt thereof recited in claims 1-24 of co-pending Application No. 18812797 is a dual agonist of GLP-1 and GIP receptors (see for example, page 1, lines 11-14 of instant specification).
18. The difference between claims 1-24 of co-pending Application No. 18812797 and instant claims 1, 2, 4, 5, 14, 17-19, 26-28, 30, 36, 43, 46, 50, 51, 54, 55, 67 and 68 is that claims 1-24 of co-pending Application No. 18812797 do not teach the limitations of instant claims 67 and 68.
However, Coskun et al, throughout the literature, teach treating type 2 diabetes with a dual agonist of GLP-1 and GIP receptors, for example, Title.
Furthermore, Marín-Peñalver et al, throughout the literature, teach various drugs that are available for treating type 2 diabetes, include metformin and many others, for example, pages 359 to 371, Sections “Oral Agents” and “Injectable Agents”.
Therefore, in view of the combined teachings of Coskun et al and Marín-Peñalver et al, it would have been obvious to one of ordinary skilled in the art to apply the polypeptide or a pharmaceutically acceptable salt thereof recited in claims 1-24 of co-pending Application No. 18812797 and develop the method recited in instant claims 67 and 68.
This is a provisional obviousness-type double patenting rejections because the conflicting claims have not in fact been patented.
Response to Applicant's Arguments
19. Applicant argues that “The present application is the first U.S. patent application filed in this patent family. The '797 Application claims priority to the present application and as such is a second-filed patent application in this patent family. Because the present application is the first-filed patent application in this patent family, the '797 Application is not a proper reference patent for double patenting”.
20. Applicant's arguments have been fully considered but have not been found persuasive.
In response to Applicant’s arguments about the ODP rejections over claims of co-pending Application No. 18812797, the Examiner understands that the instant application is the first-filed patent application in this patent family. However, in the instant case, co-pending Application No. 18812797 is a CON of instant application. And both applications have the same effective filing date. Furthermore, in the instant case, both Coskun et al (Molecular Metabolism, 2018, 18, pages 3-14, filed with IDS) and Marín-Peñalver et al (World J Diabetes, 2016, 7, pages 354-395, cited and enclosed in the previous office action) are qualified as prior art references. Therefore, it is unclear to the Examiner how and/or why the board decisions in the cited cases apply to instant rejections. Further clarification is required.
Taken all these together, until a proper terminal disclaimer is filed and approved by the Office, these double patenting rejections are hereby maintained.
Examiner’s Notes
21. As stated in the previous office action, the polypeptide or a pharmaceutically acceptable salt thereof comprising the amino acid sequence of SEQ ID NO: 1, wherein the acid group of the C terminal amino acid is a free carboxylic acid group or is amidated as a C-terminal primary amide and at least one of X3 and X5 is Lys, and with the proviso that when X1 is Aib, X2 is not Aib; a pharmaceutical composition comprising such polypeptide or a pharmaceutically acceptable salt thereof and one or more of pharmaceutically acceptable excipient; a polypeptide or a pharmaceutically acceptable salt thereof selected from the group consisting of compounds 1-12; and a method of treating or preventing hyperglycemia, type 2 diabetes, impaired glucose tolerance, type 1 diabetes, obesity, hypertension, hyperlipidemia, syndrome X, dyslipidemia, cognitive disorders, atherosclerosis, myocardial infarction, coronary heart disease, stroke, inflammatory bowel syndrome, dyspepsia, alcoholism, or gastric ulcers in a patient in need thereof, comprising administering to the patient an effective amount of the polypeptide or pharmaceutically acceptable salt thereof according to claim 1 recited in instant claims 1, 2, 4, 5, 14, 17-19, 26-28, 30, 36, 43, 46, 50, 51, 54, 55, 67 and 68 are free of prior art. The closest prior art is Alsina-Fernandez et al (WO 2016/111971 A1, filed with IDS). Alsina-Fernandez et al, throughout the patent, teach GIP-GLP-1 co-agonist of Formula I, for example, page 3, lines 22-29. The GIP-GLP-1 co-agonist of Formula I in Alsina-Fernandez et al fails to teach the limitation “with the proviso that when X1 is Aib, X2 is not Aib” in instant claimed polypeptide. And there is no teaching, motivation, or other type of suggestion to modify the GIP-GLP-1 co-agonist of Formula I in Alsina-Fernandez et al and arrive at the polypeptide or a pharmaceutically acceptable salt thereof and the pharmaceutical composition recited in instant claims 1, 2, 4, 5, 14, 17-19, 26-28, 30, 36, 43, 46, 50, 51, 54, 55, 67 and 68. Therefore, the polypeptide or a pharmaceutically acceptable salt thereof, the pharmaceutical composition, and the method of using such polypeptide or a pharmaceutically acceptable salt thereof recited in instant claims 1, 2, 4, 5, 14, 17-19, 26-28, 30, 36, 43, 46, 50, 51, 54, 55, 67 and 68 are both novel and unobvious over the prior arts of record. And the claimed polypeptide or a pharmaceutically acceptable salt thereof and pharmaceutical composition are markedly different from what exist in nature.
Conclusion
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.
No claim is allowed.
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/LI N KOMATSU/Primary Examiner, Art Unit 1658