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
Preliminary amendment filed on 07/18/2024 is acknowledged. Claims 1-11 were amended and claim 12 was cancelled. Claims 1-11 are pending in the instant application and are examined on the merits herein.
Priority
This application is a National Stage Application of PCT/KR2023/001008 filed on 01/20/2023 and claims foreign priority to REPUBLIC OF KOREA 10-2022-0008671 filed on 01/20/2022.
Information Disclosure Statement
The information disclosure statements (IDS) dated 07/18/2024, 09/04/2025, 11/17/2025, and 12/02/2025 comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, the IDS documents have been placed in the application file and the information therein has been considered as to the merits.
Claim Rejections - 35 USC § 103
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.
Claims 1 and 4-11 are rejected under 35 U.S.C. 103 as being unpatentable over Washburn et al. (US 2008/0234367 A1, published 09/25/2008, IDS dated 09/04/2025) and Melnick et al. (WO 2021/207723 A1, published 10/14/2021, PTO-892).
Washburn teaches treating obesity or causing weight loss in a mammalian subject or patient, wherein a therapeutically effective amount of an SGLT2 inhibitor alone or in combination with another anti-obesity agent is administered to a mammalian subject. In addition, Washburn teaches a pharmaceutical composition comprising an SGLT2 inhibitor, alone or in combination with another anti-obesity agent, and a pharmaceutically acceptable carrier (abstract). Washburn teaches that hyperglycemia is a hallmark of diabetes. Plasma glucose is normally filtered in the kidney in the glomerulus and actively reabsorbed in the proximal tubule. Sodium-dependent glucose transporter SGLT2 appears to be the major transporter responsible for the reuptake of glucose at this site. Long term (6 month) treatment of Zucker diabetic rats with an SGLT2 inhibitor has been reported to improve insulin response to glycemia, improve insulin sensitivity, and delay the onset of nephropathy and neuropathy in these animals, with no detectable pathology in the kidney and no electrolyte imbalance in plasma. Selective inhibition of SGLT2 in diabetic patients would be expected to normalize plasma glucose by enhancing the excretion of glucose in the urine, thereby improving insulin sensitivity and delaying the development of diabetic complications, meeting the limitation of reduced serum insulin concentration in instant claim 9 (paragraph 0003). Inhibition of SGLT2 would be predicted to reduce plasma glucose levels via enhanced glucose excretion in diabetic patients (paragraph 0004). Washburn teaches a method for promoting, increasing or enhancing glucosuria in a mammalian subject or patient to effect weight loss, which includes the step of administering to a mammalian subject or patient in need of such treatment a therapeutically effective (glucosuria-enhancing or weight-reducing) amount of an SGLT2 inhibitor (paragraph 0010). The subject may be obese (paragraph 0011). The mammalian subject may be a dog (paragraph 0147). The compounds may be administered orally or parenterally (paragraph 0147). Washburn teaches that the amount of drug required for therapeutic effect varies with the agent chose, the nature and severity of the condition, and the mammal undergoing treatment, and is ultimately at the discretion of the physician. The optimal quantity and spacing of individual dosages of a drug is determined by the nature and extent of the weight loss desired, the form, route, and site of administration, the particular mammal or patient being treated. In one embodiment, Washburn teaches that the SGLT2 inhibitor dose for adults is between 1 and 350 mg per day which can be administered in a single dose or in the form of individual doses from 1-4 times per day. Further, the optimal course of treatment, that is, the number of doses given, can be ascertained by those skilled in the art using conventional course of treatment determination tests (paragraph 0148). The SGLT2 inhibitors that would be suitable for the method include C-aryglucosides such as a compound shown below, which would meet the limitation of being empagliflozin when A is a CH2, R2a and R1 together form an annelated five membered heterocycle containing an oxygen, R4 is a cycloaklyl, and R2 and R3 are hydrogens (paragraphs 0073-0075).
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Washburn (paragraph 0080).
Washburn does not exemplify that the SGLT2 inhibitor is enavogliflozin.
Melnick is drawn to methods of treating diabetic kidney disease comprising administering atrasentan and a SGLT-2 inhibitor to a subject in need thereof (abstract). Melnick teaches that an SGLT-2 inhibitor provides a benefit to patients by reducing fluid retention which thereby reduces the subjects’ weight (paragraph 006). Melnick teaches that enavogliflozin is an SGLT2 inhibitor (claim 30).
It would have been prima facie obvious to combine the teachings of Washburn and Melnick before the effective filing date of the claimed invention to substitute the enavogliflozin as the SGLT2 inhibitor as taught by Melnick in the method for treating obesity in a subject that is canine as taught by Washburn to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to select enavogliflozin as the SGLT2 inhibitor in the method for treating obesity in a subject that is canine as taught by Washburn because Washburn teaches that an SGLT2 inhibitor with a formula structure that meets the limitation of enavogliflozin may be used and Melnick teaches that enavogliflozin is an SGLT2 inhibitor. One of ordinary skill in the art would have a reasonable expectation of success because Washburn teaches that an SGLT2 inhibitor with a formula structure that meets the limitation of enavogliflozin may be used for weight loss in dogs and Melnick teaches that enavogliflozin is an SGLT2 inhibitor that may reduce weight in a subject.
Regarding instant claims 4-7, it would have been prima facie obvious to combine the teachings of Washburn and Melnick before the effective filing date of the claimed invention to optimize the amount of enavogliflozin as taught by Melnick administered to be between 1 mg and 350 mg once a day for the length of time as determined by a physician as taught by Washburn to arrive at the claimed invention. It would have been prima facie obvious for a person of ordinary skill in the art to optimize the amount of enavogliflozin to between 1 mg and 350 mg once a day for the length of time as determined by a physician because Washburn teaches that the optimal quantity and spacing of individual dosages of a drug is determined by the nature and extent of the weight loss desired, the form, route, and site of administration, the particular mammal or patient being treated and gives an example of treating an adult with a daily dose of 1 mg to 350 mg of an SGLT2 inhibitor. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). (MPEP § 2144.05(I)) Moreover, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). (MPEP § 2144.05(II)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003).
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Washburn et al. (US 2008/0234367 A1, published 09/25/2008, IDS dated 09/04/2025) as applied to claim 1 above, and further in view of Kley et al. (US 2016/0361289 A1, published 12/15/2016, PTO-892)
Claim 1 is rejected as discussed above.
The teachings of Washburn are discussed above. Washburn does not teach wherein the canine animals have a body condition score (BCS) of 6 or more.
Kley is drawn to the treatment of metabolic disorders in canine animals (title). Kley teaches the use of a SGLT2 inhibitor in treating a metabolic disorder in a canine animal wherein the metabolic disorder is selected from a group that comprises obesity and hyperglycemia (abstract). Kley teaches that in an obese canine, the canine has a body condition score (BCS) of larger than 7.
It would have been prima facie obvious to combine the teachings of Washburn and Kley before the effective filing date of the claimed invention by apply the method of treating obese canines with the SGLT2 inhibitor enavogliflozin as taught by Washburn to obese canines with a body condition of 7 or greater as taught by Kley to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to apply the method of treating obese canines with the SGLT2 inhibitor enavogliflozin as taught by Washburn to obese canines with a body condition of 7 or greater as taught by Kley because both Washburn and Kley are directed to the treatment of obese canines with an SGLT2 inhibitor. One of ordinary skill in the art would have a reasonable expectation of success because Washburn teaches the treatment of obese canines with the SLGT2 inhibitor, enavogliflozin, and Kley teaches the treatment of obese canines with a body composition of 7 or greater with an SLGT2 inhibitor. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). (MPEP § 2144.05(I)) Moreover, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). (MPEP § 2144.05(II)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003).
Conclusion
No claims are allowed.
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/S.L.S./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693
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