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 .
DETAILED ACTION
The election without traverse filed July 1, 2026, is acknowledged.
After further consideration of the prior art and the application as a whole, the species requirements have been withdrawn.
Claims 1-26 are pending in the application and are under examination.
Information Disclosure Statement
The information disclosure statement has been considered.
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 obviousness-type 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); 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 conflicting 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.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of copending Application No 19/534,466 and Carrier et al (WO 2011/109784 A1, IDS). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
The claims of Application ‘466 disclose compositions comprising:
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Carrier et al disclose treating Type II non-insulin dependent diabetes by administering to a subject a therapeutically effective amount of a composition comprising a GLP-1 agonist peptide covalently coupled via a linker to Cys34 amino acid of an albumin, including a conformationally modified albumins and further comprising free albumin (has an unreacted Cys34 group, which would ensure the composition was substantially free of unbound GLP-1).
Accordingly, one of skill in the art would be motivated to use the compositions claimed in the application in the methods of Carrier as they would recognize that these compositions would be effective in treating Type II non-insulin dependent diabetes. These methods would meet the other instantly claimed limitations because the albumin in the ‘141 encompasses albumin with no hydrophobic ligands in any hydrophobic binding pockets and non-insulin dependent diabetes occurs in patients with other diseases such that patients diagnosed with non-insulin dependent diabetes includes patients diagnosed with other diseases such as those instantly claimed.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of US Patent 12,551,541. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
The claims of ‘541 recite:
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Accordingly, these claims anticipate the instant claims such that the instant claims are not patentably distinct.
Claims 1-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of US Patent 12,576,141 and Carrier et al (WO 2011/109784 A1, IDS). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
The claims of ‘141 recite:
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Carrier et al disclose treating Type II non-insulin dependent diabetes by administering to a subject a therapeutically effective amount of a composition comprising a GLP-1 agonist peptide covalently coupled via a linker to Cys34 amino acid of an albumin, including a conformationally modified albumins and further comprising free albumin (has an unreacted Cys34 group, which would ensure the composition was substantially free of unbound GLP-1).
Accordingly, one of skill in the art would be motivated to use the compositions claimed in the application in the methods of Carrier as they would recognize that these compositions would be effective in treating Type II non-insulin dependent diabetes. These methods would meet the other instantly claimed limitations because the albumin in the ‘141 encompasses albumin with no hydrophobic ligands in any hydrophobic binding pockets and non-insulin dependent diabetes occurs in patients with other diseases such that patients diagnosed with non-insulin dependent diabetes includes patients diagnosed with other diseases such as those instantly claimed.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed. The closest prior art is Carrier et al (WO 2011/109784 A1, IDS). Carrier et al disclose treating Type II non-insulin dependent diabetes by administering to a subject a therapeutically effective amount of a composition comprising a GLP-1 agonist peptide covalently coupled via a linker to Cys34 amino acid of an albumin, including a conformationally modified albumins and further comprising free albumin (has an unreacted Cys34 group, which would ensure the composition was substantially free of unbound GLP-1), where the amount can be 500 mcg administered subcutaneously once a week (see entire document, e.g., pages 19, 25-28, 89, 116, 119, 124 and 152 and claims). However, Carrier et al do not appear to disclose or suggest using albumin with no hydrophobic ligands in any hydrophobic binding pockets to make their GLP-1 agonist peptide-albumin conjugates.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brad Duffy whose telephone number is (571) 272-9935. The examiner works a flexible schedule.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Julie Wu can be reached on (571) 272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Respectfully,
Brad Duffy
571-272-9935
/Brad Duffy/
Primary Examiner, Art Unit 1643
July 22, 2026
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