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 .
Claims 29-48 are pending and under consideration.
Information Disclosure Statement
The Information Disclosure Statements (IDSs) filed on 2/29/2004, 8/28/2025, 3/9/2026 and 7/8/2026 have been considered.
Priority
The instant application if a CON of US Application No. 18/084,088, now US Pat. No. 12,054,528.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 29-30 and 32-48 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating diabetes in a subject having diabetes comprising administering a GLP-1 receptor-amylin receptor co-agonist and a pharmaceutically acceptable excipient, wherein the co-agonists are recited in claim 29, does not reasonably provide enablement for a method of treating diabetes in a subject not having diabetes, or a method of delaying progression of diabetes in any subject (who may not be at risk or a subject who may be only a day or a month old and not diagnosed to be at risk of developing diabetes) comprising administering a GLP-1 receptor-amylin receptor co-agonist and a pharmaceutically acceptable excipient, wherein the co-agonists are recited in claim 29. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
In In re Wands, 8USPQ2d, 1400 (CAFC 1988) page 1404, the factors to be considered in determining whether a disclosure would require undue experimentation include: (1) Nature of the invention, (2) the state of the prior art, (3) the predictability or lack thereof in the art, (4) the amount of direction or guidance present, (5) the presence or absence of working examples, (6) the breath of the claims, (7) the quantity of experimentation needed, (8) relative skill of those in the art.
The instant disclosure fails to meet the enablement requirement for the following reasons:
Claims 29-30 and 32-48 are broadly drawn to a method of treating diabetes in a subject (not having diabetes), or a method of delaying progression of diabetes in any subject (who may not be at risk or a subject may be only a day or a month old) comprising administering a GLP-1 receptor-amylin receptor co-agonist and a pharmaceutically acceptable excipient, wherein the co-agonists are recited in claim 29.
The state of the prior art and the predictability or lack thereof in the art:
Perfetti et al. (Eur. J. Endocr. 143, 717-725, 2000) teach that the glucagon-like polypeptide-1 (GLP-1) is a 30 amino acid derivative of proglucagon (PG) hormone. Mammalian PG is 160 amino acid residues in length and gives rise to glucagon, GLP-1 (aa 78-107), GLP-1 and other peptides (IP-1 and IP-2) of unknown biological activity (page 717). Perfetti et al. teach that the amino acid sequence of GLP-1 is 100% homologous in all mammalian species and highly homologous in many lower vertebrates. The L-cells of large intestine (the ileum, colon and rectum) produce GLP-1 which is cleaved to form the biologically active GLP-1 (7-37), which is then C-terminally truncated and amidated to form the GLP-1 (7-36) amide. Kieffer et al. (Endocr. Rev. 20: 876-913, 1999) teach that essentially the entire amino acid sequence of GLP-1 is required for full biological activity (page 880, right column). Nevola et al. (IDS, Int. J. Molecular Sci. 2023) teach that GLP-1 analogs are useful in treating diabetes and now they are being used for reducing body weight and treating NASH. Rasmus et al. (EP3271381) teach that amylin reduces body weight is beneficial in treating metabolic disorders ( see paragraph [0002]). Levy et al. (IDS, US Pub. No. 2006/0094652) teach a fusion protein between exendin and amylin that reduces body weight in a subject. Claudia et al. (IDS of 3/9/2026) teach that amylin/GLP-1 promotes long lasting weight loss. Therefore, the art supports amylin and GLP-1 combination for treating diabetes or reducing body weight. ). However, the art does not teach that administering GLP-1 and amylin fusion protein or a combination thereof to any subject (who does not have diabetes) or to any subject including an infant, child, or any subject who may or may not be at risk of developing diabetes to delay progression of diabetes. The art does not teach administering either GLP-1, amylin or a fusion thereof to delay the progression of diabetes in any subject including infants, children or any subject not in need thereof. Therefore, it is unpredictable and would require a large amount of experimentation to delay progression of diabetes in any subject or treating any subject who may not have diabetes comprising administering a GLP-1 receptor-amylin receptor co-agonist and a pharmaceutically acceptable excipient, wherein the co-agonists are recited in claim 29.
The amount of direction and guidance present and the presence or absence of working examples: Given the teachings found in the art, detailed teachings are required to be present in the disclosure in order to enable the skilled artisan to practice the invention as claimed. These teachings are absent. The specification of pages 246-263 disclose in vitro binding assay for different GLP-1/amylin fusion using GLP-1 receptor and amylin receptor. The specification does not teach administering GLP-1/amylin co-agonist to any subject that demonstrates delaying progression of diabetes or treating a subject who do not have diabetes and the subject is not in need of treatment. The art or the specification is devoid of any example where the administration of GLP-1 receptor agonist and amylin receptor co-agonist can delay progression of diabetes and is analogous to preventing diabetes in any subject. Therefore, it is unpredictable how one of the skill in the art can practice the instantly claimed invention.
The breadth of the claims and the quantity of experimentation needed: Due to the large quantity of experimentation necessary to delay progression of diabetes in any subject (who are not at risk of developing diabetes) and to treat a subject who may not develop diabetes comprising administering GLP-1 receptor- amylin receptor co-agonist of claim 29, the lack of direction/guidance presented in the specification regarding the same, the state of the prior art which establishes the unpredictability about delaying progression of diabetes in any subject (who are not in need thereof), undue experimentation would be required of the skilled artisan to make and/or use the claimed invention in its full scope.
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 29-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 12,054,528. Although the claims at issue are not identical, they are not patentably distinct from each other because a method of treating diabetes in a human subject comprising a glucagon-like peptide-1 (GLP-1) receptor amylin receptor co-agonist selected from the group consisting of: (i) H-Aib- EGTFTS DVS-K([2-[2-[2-[[2-[2-[2-[[(4S)-4-carboxy-4-(17- carboxyheptadecanoylamino)butanoyl]amino]ethoxy]ethoxy]acetyl]amino]ethoxy]ethoxy]acetyl]) YLEEQAAREFIAWLVRGR GGGGGEASELSTAALGRLSA
ELHELATLPRTETGSGSP- amide, and H-Aib-EGTFTSDVSSYLEEQ
AAREFIAWLVRGR-K([2-[2-[2-[[2-[2-[2-[[(4S)-4-carboxy-4-(19- carboxynonadecanoylamino)butanoyl]amino]ethoxy]ethoxy]acetyl]amino]ethoxy]ethoxy]acetyl])-GGGGEASELSTAALGRLSAELHELATLPRTETGSGSP-amide and a method of treating diabetes in a human subject, comprising administering to said human subject a pharmaceutical formulation comprising a Glucagon-Like Peptide-1 (GLP- 1) receptor-amylin receptor co-agonist and a pharmaceutically acceptable excipient, wherein said diabetes is hyperglycemia, type 2 diabetes, impaired glucose tolerance, type 1 diabetes, non-insulin dependent diabetes, MODY (maturity onset diabetes of the young), or gestational diabetes, wherein said patient has one or more diabetes associated comorbidity, wherein said human subject suffers from overweight, wherein said human subject has an initial body mass index (BMI) of 27 or more, wherein said human subject has at least one weight- related comorbidity selected from the group consisting of diabetes, hypertension, dyslipidemia, high cholesterol and obstructive sleep apnea, and wherein said human subject has cardiovascular disease, non-steroidal steatohepatitis or cognitive impairment are taught in claims 1-24 of U.S. Patent No. 12,054,528.
Claims 29-48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3-21 of copending Application No. 19/409,120 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because a method of treating diabetes in a human subject comprising a glucagon-like peptide-1 (GLP-1) receptor amylin receptor co-agonist selected from the group consisting of: (i) H-Aib- EGTFTS DVS-K([2-[2-[2-[[2-[2-[2-[[(4S)-4-carboxy-4-(17- carboxyheptadecanoylamino)butanoyl]amino]ethoxy]ethoxy]acetyl]amino]ethoxy]ethoxy]acetyl]) YLEEQAAREFIAWLVRGR GGGGGEASELSTAALGRLSA
ELHELATLPRTETGSGSP- amide, and H-Aib-EGTFTSDVSSYLEEQ
AAREFIAWLVRGR-K([2-[2-[2-[[2-[2-[2-[[(4S)-4-carboxy-4-(19- carboxynonadecanoylamino)butanoyl]amino]ethoxy]ethoxy]acetyl]amino]ethoxy]ethoxy]acetyl])-GGGGEASELSTAALGRLSAELHELATLPRTETGSGSP-amide and a method of treating diabetes in a human subject, comprising administering to said human subject a pharmaceutical formulation comprising a Glucagon-Like Peptide-1 (GLP- 1) receptor-amylin receptor co-agonist and a pharmaceutically acceptable excipient, wherein said diabetes is hyperglycemia, type 2 diabetes, impaired glucose tolerance, type 1 diabetes, non-insulin dependent diabetes, MODY (maturity onset diabetes of the young), or gestational diabetes, wherein said patient has one or more diabetes associated comorbidity, wherein said human subject suffers from overweight, wherein said human subject has an initial body mass index (BMI) of 27 or more, wherein said human subject has at least one weight- related comorbidity selected from the group consisting of diabetes, hypertension, dyslipidemia, high cholesterol and obstructive sleep apnea, and wherein said human subject has cardiovascular disease, non-steroidal steatohepatitis or cognitive impairment are taught in claims 3-21 of US Application No. 19/409,120.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GYAN CHANDRA whose telephone number is (571)272-2922. The examiner can normally be reached Mon-Friday 8:30AM-5:00P.
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, Vanessa Ford can be reached at 571-272-0857. 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.
/GYAN CHANDRA/Primary Examiner, Art Unit 1674
Prosecution Insights