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 .
Restriction/Election
Applicant’s election without traverse of Group I, claims1-8 and the species SEQ ID NO: 502, in the reply filed on 05/11/26 is acknowledged.
Claims 9-21 have been canceled as of the amendment of 05/11/26. New composition claims 22-30 were added. A search of the elected species was free of the art, except for NSDP rejections that follow, and the search was extended to all claims and species. As such, all of claims 1-8 and 22-30 are pending and all are under examination. An Office action on the merits follows.
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 1-8 and 22-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,516,095. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 is drawn to the genus:
PNG
media_image1.png
672
612
media_image1.png
Greyscale
PNG
media_image2.png
112
316
media_image2.png
Greyscale
Formula I of claim 1 meets the limitations of instant claim 1 because each of the options for X-W-Y1-Y2 overlap with the claimed genus. The instantly claimed genus of peptides drawn to SEQ ID NO: 528 are met where the fully defined positions have the same positions as designated:
PNG
media_image3.png
154
726
media_image3.png
Greyscale
Where each of the variable Xaa1-Xaa42 have the same claimed residues, and where instantly claimed Z is met by Y2, having the same optional amino acids and the same option for the ɛ-amino of lysine to be attached to the instantly claimed variable Z. Instant claims 2-4 and 24-29 are met because the same variables are taught for each of the narrower species of variables Xaa1-Xaa42 and Z (See claims 2-10 and 13). Instant claim 5 is met by claim 14 teaching C-terminal amidation. Instant claims 6-8 are met by claims 15, 18 and 19 teaching additional therapeutic agents in pharmaceutically acceptable salts.
Claims 1-8 and 22-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,516,095 in view of Wilson (US2013/0303436).
The difference between ‘095 and the instant claim 30 is that ‘095 does not teach acetate salts.
However, Wilson teaches GLP-1 variants, analogues, or pharmaceutically acceptable salts thereof, alone or in combination with one or more active agents, such as D-Arg-2'6'-Dmt-Lys-Phe-NH.sub.2 to be used in therapeutic applications, compositions or medicaments in pharmaceutically acceptable acetate salts [0296].
It would have been obvious at the filing date of the invention to have taken the GLP-1 pharmaceuticals of ‘095 and used the acetate salt of Wilson because Wilson teaches similar pharmaceutical compositions comprising GLP-1 variants. One would be motivated to do so because both references teach pharmaceutical salts and Wilson teaches that acetate is a preferable salt form of such formulations for therapeutic administration. As such, there is a reasonable expectation of success that the GLP-1 peptide of ‘095 can be effectively used as an acetate salt for therapeutic administration for treating GLP-1 related conditions.
As such, claims 30 is rendered obvious.
Claims 1-4, 6-8, 22-23 and 25-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 12,497,438. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-4 of ‘438 are drawn to the following:
PNG
media_image4.png
746
610
media_image4.png
Greyscale
This meets the limitations of instant claims 1-4, 22, 23 and 25-29 by teaching a species that anticipates the genera of peptides that fall within SEQ ID NO: 528, where each of Xaa1-Xaa42 is the above listed position and where Z is the same group with a R as a C18 alkyl.
Instant claims 7-8 and 30 are met by claims 2, 3, 5-8 which teach acetate salts and pharmaceutical formulations for subcutaneous administration.
Claim 6 is met because the additional therapeutic agent may be administered separately, which is not a part of the composition as claimed. Because the instant claims are not drawn to a method of administration, the broadest reasonable interpretation of the claimed formulation is on that has only the claimed peptide in a pharmaceutical carrier. The limitation “for simultaneous, sequential or separate administration” applies to the therapeutic agent as a separate formulation that is not part of the claimed formulation, but part of a method of treatment.
Claims 1-8, 22-23 and 25-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 12,497,438 in view of Wilson (US2013/0303436).
The difference between ‘438 and the instant claim 5 is that ‘438 does not teach that the C-terminus may be amidated.
Wilson teaches that the C-terminal amino acid is preferably amidated in GLP-1 variants, analogues, or pharmaceutically acceptable salts thereof, alone or in combination with one or more active agents, such as D-Arg-2'6'-Dmt-Lys-Phe-NH.sub.2 to be used in therapeutic applications, compositions or medicaments as pharmaceutically acceptable acetate salts [0296, 0066].
It would have been obvious at the filing date of the invention to have taken the GLP-1 pharmaceuticals of ‘438 and used the acetate salt and amidation method of Wilson because Wilson teaches similar pharmaceutical compositions comprising GLP-1 variants. One would be motivated to do so because both references teach GLP-1 pharmaceutical salt formulations and Wilson provides motivation to amidate the C-terminus as the preferable form of such GLP-1 peptide formulations for therapeutic administration. As such, there is a reasonable expectation of success that the amidated form of the GLP-1 peptide of ‘438 can be effectively used for therapeutic administration in methods of treatment of GLP-1 related conditions.
As such, claim 5 is rendered obvious.
Claims 1-4, 6-8 and 22-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of copending Application No. 19/364,944 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 teaches:
PNG
media_image5.png
746
306
media_image5.png
Greyscale
PNG
media_image6.png
372
294
media_image6.png
Greyscale
Formula I of claim 1 meets the limitations of instant claim 1 because each of the options for X-W-Y1-Y2 overlap with the claimed genus. The instantly claimed genus of peptides drawn to SEQ ID NO: 528 are met where the fully defined positions have the same positions as designated:
PNG
media_image3.png
154
726
media_image3.png
Greyscale
Where each of the variable Xaa1-Xaa42 have the same claimed residues, and where instantly claimed Z is met by Y2, having the same optional amino acids and the same option for the ɛ-amino of lysine to be attached to the instantly claimed variable Z. Instant claims 2-4 and 24-29 are met because the same variables are taught for each of the narrower species of variables Xaa1-Xaa42 and Z that fall within the genus of formula I. Instant claims 6-7 are met by claims 3-4, teaching additional therapeutic agents in pharmaceutically acceptable salts and carriers. Claim 8 is met because claim 5 of ‘944 teaches a syringe formulation for subcutaneous administration.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-8 and 22-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of copending Application No. 19/364,944 (reference application) in view of Wilson (US2013/0303436).
The difference between ‘944 and instant claims 5 and 30 is that ‘944 does not teach amidated C-termini or acetate as the preferred pharmaceutical salt.
However, Wilson teaches GLP-1 variants, analogues, or pharmaceutically acceptable salts thereof, alone or in combination with one or more active agents, such as D-Arg-2'6'-Dmt-Lys-Phe-NH.sub.2 to be used in therapeutic applications, compositions or medicaments in pharmaceutically acceptable acetate salts [0296].
It would have been obvious at the filing date of the invention to have taken the GLP-1 pharmaceuticals of ‘944 and used the amidated GLP-1 acetate salt of Wilson because Wilson teaches similar pharmaceutical compositions comprising GLP-1 variants. One would be motivated to do so because both references teach pharmaceutical salts and Wilson teaches that amidated form and acetate salts are preferable forms of such formulations for therapeutic administration. As such, there is a reasonable expectation of success that the amidated GLP-1 peptide of ‘944 can be effectively used as an acetate salt for therapeutic administration for treating GLP-1 related conditions.
As such, claims 5 and 30 are rendered obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEANETTE M LIEB whose telephone number is (571)270-3490. The examiner can normally be reached M-F 10-7.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached on 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JEANETTE M LIEB/Primary Examiner, Art Unit 1654
Prosecution Insights