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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/03/2026 has been entered.
Priority
This application is a CON of 18/339,305 filed on 06/22/2023. 18/339,305 is a CON of 17/306,782 filed on 05/03/2021 now Patent 11738086. 17/306,782 is a CON of 16/461,329 filed on 05/15/2019 now Patent 11020484. 16/461,329 is a 371 of PCT/US2017/062838 filed on 11/21/2017. PCT/US2017/062838 has PRO 62/517,065 filed on 06/08/2017. PCT/US2017/062838 has PRO 62/424,979 filed on 11/21/2016.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement filed 10/17/2025, fails to comply with the provisions of 37 CFR 1.97(a) because it lacks the appropriate size fee set forth in 37 CFR 1.17(v). It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
The information disclosure statements submitted on 11/04/2025, 03/26/2026 and 08/03/2026 have been considered by the examiner.
Claim Status
Claims 1-4, 7-21 are pending. Claims 1 is amended. Claims 5-6 are canceled. Claims 1-4, 7-21 are being examined on the merits in this office action.
Claim Rejections - Withdrawn
The rejection of claims 1-4, 7-21 under 35 U.S.C. 103 as being unpatentable over by Kolterman et al. (US6902744B1 – hereinafter “Kolterman”) in view Stoffers et al. (US20080269130A1 – hereinafter “Stoffers”) is withdrawn in view of the claim amendments.
The rejection of claims 1-3, 10-11, 14-17 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 29-34, 38-47 of copending Application No. 18/339,305 is withdrawn in view of the approved Terminal Disclaimer.
The rejection of claims 1-4, 10, 14-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-10, 14-15, 17-21, 24, 31 of U.S. Patent No. US10993992B2 in view of Young et al. (WO2000041546A2 – hereinafter “Young”) is withdrawn in view of the claim amendments.
The rejection of claims 1-3, 7, 10, and 14-18 on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-10,15-21 and 24 of U.S. Patent No. US10993991B2 in view of Young et al. (WO2000041546A2 – hereinafter “Young”) is withdrawn in view of the claim amendments.
The rejection of claims 1-3, 7, 10, and 14-18 on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 6-13, 14-15, 19-23 of U.S. Patent No. US10639354B2 in view of Young et al. (WO2000041546A2 – hereinafter “Young”) is withdrawn in view of the claim amendments.
The rejection of claims 1-3, 10, and 14-20 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-4, 7, 10-12, 14, 16-17 of U.S. Patent No. US12220444B2 in view of Young et al. (WO2000041546A2 – hereinafter “Young”) is withdrawn in view of the claim amendments.
The rejection of claims 1-3, 10, 14-18 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 32-36, and 39 of copending application 18/745,091 in view of Young et al. (WO2000041546A2 – hereinafter “Young”) is withdrawn in view of the claim amendments.
Claim Rejections - 35 USC § 103 – New
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 7-21 remain rejected under 35 U.S.C. 103 as being unpatentable over by Kolterman et al. (US6902744B1 – hereinafter “Kolterman”) in view Stoffers et al. (US20080269130A1 – hereinafter “Stoffers”) and Sarubbi (US20100016229A1).
Kolterman teaches exendin (9-39) analogs and teaches formulations that comprise the exendin and a buffer such as acetate buffer and an iso-osmolality modifier preferably mannitol (Col. 3, line 1-40; Col. 88, line 53-61; Col. 5, line 20-30; Col. 7, line 55-58). Kolterman teaches that the formulation has a pH of between 4.0 to about 6.0 (Col. 5, line 56). Kolterman teaches the formulation comprising up to 50 mg/ml of exendin (Col. 7, line 55-58).
The difference between the Kolterman and the instant claims is that the Kolterman does not specifically teach that the exendin 9-39 is used with the combination of the recited agents in a particular formulation and does not teach the concentration of 100mg/ml.
Stoffers teaches compositions and methods (Abstract), wherein the composition comprises the GLP-1R antagonist exendin (9-39) [0062, 0064, 0085, 0099-0103]. Stoffers teaches the composition comprises mannitol [0106], and buffers such as acetate buffer [0109]. Stoffers teaches that the composition is subcutaneously administered [0100, 0104, 0108]. Stoffers teaches the composition for treating hypoglycemia in subjects with hyperinsulinism [0014-0017].
Sarubbi teaches GLP-1 formulation that comprise mannitol and buffers such as acetate buffer (Abstract; [0142-0144, 0151]. Sarubbi teaches that the GLP-1 compounds include Exendin fragments which are polypeptides obtained after truncation of one or more amino acids from the N-terminus and/or C-terminus of Exendin or an Exendin analog [0111], and that an N-terminally truncated derivative of Exendin, is known as Exendin (9-39 amino acids) [0107]. Sarubbi teaches that the GLP-1 can be in the concentration of 100 mg/ml [0162].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Kolterman and Stoffers and use exendin 9-39 in the composition of Kolterman as the peptide of both Kolterman and Stoffers are similar. Additionally, it would have been obvious to have the exendin (9-39) in the concentration of 100 mg/ml since Sarubbi teaches formulations that include exendin (9-39) at the instantly taught concentration. One of ordinary skill in the art would be motivated and would have had a reasonable expectation of success in preparing such a composition so as to treat hypoglycemia. The disclosures render obvious claim 1.
Regarding claim 2, Kolterman teaches that exendin can also be formulated as pharmaceutically acceptable salt such as acetate (Col. 17, line 65-67, Col. 18, line 11-13).
Regarding claim 3, Kolterman teaches exendin (9-39) analogs and teaches formulations that comprises the exendin and a buffer such as acetate buffer and an iso-osmolality modifier preferably mannitol (Col. 3, line 1-40; Col. 88, line 53-61; Col. 5, line 20-30; Col. 7, line 55-58). Kolterman teaches that the formulation has a pH of between 4.0 to about 6.0 (Col. 5, line 56).
Regarding claim 4, Kolterman teaches the formulation comprises acetate buffer in the amount of 30 Mm[ (col. 7, line 55-58). Examiner notes that the concentration of the active agent is a result effective variable and the determination of the optimum or workable ranges of said variable may be characterized by routine experimentation (See MPEP 2144 II). It would be obvious and routine experimentation to a person of ordinary skill in the art with a reasonable expectation of success to optimize the concentration to arrive at the concentration of the instant claim 4.
Regarding claim 7, Kolterman teaches the formulation comprises mannitol at approximately 1-10% w/v (which is 10-100 mg/ml) (Col. 5, line 57-59) specifically, 4.3% w/v (which is 43mg/ml) (Col. 33, line 55-56).
Regarding claims 8-9, Kolterman teaches exendin (9-39) analogs and teaches formulations that comprises the exendin and a buffer such as acetate buffer and an iso-osmolality modifier preferably mannitol (Col. 3, line 1-40; Col. 88, line 53-61; Col. 5, line 20-30; Col. 7, line 55-58). Kolterman teaches the formulation comprises mannitol at approximately 1-10% w/v (which is 10-100 mg/ml) (Col. 5, line 57-59) specifically, 4.3% w/v (which is 43mg/ml) (Col. 33, line 55-56). Examiner notes that Kolterman discloses the instant concentrations of mannitol that is used to produce the osmolality of the formulation. Thus, the instant osmolality recited in claims 8-9 is achieved by Kolterman since they teach mannitol as the osmolality modifier and teaches the instant concentrations of mannitol rendering the claims obvious. Further, the concentration of the active agent is a result effective variable and the determination of the optimum or workable ranges of said variable may be characterized by routine experimentation (See MPEP 2144 II). It would be obvious and routine experimentation to a person of ordinary skill in the art with a reasonable expectation of success to optimize the concentrations of mannitol to arrive at the osmolality of the instant claims.
Regarding claim 10, Kolterman teaches the composition for subcutaneous administration (Col.10, line 2-4; Col. 12, line 1; Col. 17, line 40-41). Further, Stoffers teaches that the composition is subcutaneously administered [0100, 0104, 0108].
Regarding claim 11-13, Stoffers teaches that the formulation does not aggregate [0114]. Further, Examiner notes that the cited references teach the instant composition which will thus display the same properties of lacking aggregation or precipitation. When the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. MPEP 2112.01 (I). It would have been obvious to combine the teachings of Kolterman and Stoffers to arrive to such a composition.
Regarding claims 14 and 21, Stoffers teaches that the composition is subcutaneously administered [0100, 0104, 0108]. Stoffers teaches the composition for treating hypoglycemia in subjects with hyperinsulinism [0014-0017]. Stoffers teaches that the method was effective in reducing an incidence of hypoglycemia [0007-0009, 0011-0017]. It would have been obvious to combine the teachings of Kolterman and Stoffers to arrive to such a composition for treating hyperinsulinemic hypoglycemia.
Regarding claims 15-17, Stoffers teaches subjects with post-prandial hypoglycemia after Nissen fundoplication or gastric-bypass surgery [0050-0054]. Examiner notes that Nissen fundoplication and gastric-bypass surgery are a type of upper gastrointestinal procedure and post-prandial hypoglycemia after gastric bypass also reads on post-bariatric hypoglycemia which develops after a meal after the surgery.
Regarding claim 18, Kolterman teaches that the formulation is administered 1 or 2 times per day (Col. 8, line 26-27).
Regarding claims 19-20, Stoffer teaches a dose of 200 or 250 or 300 pmol/kg/min [0117-0118]. Examiner notes that dose of 300 pmol/kg/min translates to 0.06 mg/kg/hr, and for an adult of the average weight of about 63 kg, in 24 hours (day), the dose will be about 63x24x0.06 = 92 mg, which reads on claims 19-20.
Response to Arguments
Applicant’s arguments, see Applicant Arguments, filed 08/03/2026, with respect to the rejection(s) of claim(s) 1-21 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Sarubbi et al. (US20100016229A1).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mercy H. Sabila whose telephone number is (571)272-2562. The examiner can normally be reached Monday - Friday 5:00 am - 3:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko G. Garyu can be reached at (571)270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MERCY H SABILA/Examiner, Art Unit 1654
/TARA L MARTINEZ/Primary Examiner, Art Unit 1654
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