ilkDETAILED 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 .
Status of Claims
Claims 1-10 are pending in the instant application. Claims 1-10 are amended via the amendment filed October 26th, 2023.
Priority
This is a 35 U.S.C. 371 National Stage filing of International Application No. PCT/KR2022/006120 filed April 28th, 2022, which claims priority under 35 U.S.C. 119(a-d) to KR10-2021-0055992, filed April 29th, 2021. Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d)
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed 10/26/2023 was considered by the Examiner.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-8 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liang et al (US 2017/0290800 A1) in view of Kang et al (WO 2018/111012 A1).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Liang teaches a method of treating type II diabetes mellitus comprising administering to a subject in need thereof a therapeutically effective amount of a pharmaceutical composition comprising a GPR40 agonist and an SGLT2 inhibitor (claim 37). Liang teaches that the SGLT2 inhibitor is dapagliflozin or empagliflozin (claim 21).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
Liang does not teach that the GPR40 agonist is of instant formula 1.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
However, Kang teaches GPR40 agonists. Kang teaches a method for the treatment of a metabolic disorder, such as type 2 diabetes, comprising administering to a subject a pharmaceutical composition comprising the following compound (claim 8, example 27):
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169
408
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This compound is embraced by instant formula 1.
Regarding claim 1, as Liang teaches a method of treating type 2 diabetes mellitus with a combination of a GRP40 agonist and a SGLT2 inhibitor, one of ordinary skill in the art would have been motivated to include the compound of instant formula 1 in the combination as Kang teaches that the compound of instant formula 1 is a GRP40 agonist and treats type 2 diabetes.
Further, as both dapagliflozin or empagliflozin and the compound of instant formula 1 are both known to treat type 2 diabetes mellitus, one of ordinary skill in the art would have been motivated to combine the two to create a third composition for the same purpose. See MPEP 2144.06: "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious); and In re Couvaras, 70 F.4th 1374, 1378-79, 2023 USPQ2d 697 (Fed. Cir. 2023) (That the two claimed types of active agents, GABA-a agonists and ARBs, were known to be useful for the same purpose—alleviating hypertension—alone can serve as a motivation to combine).
Regarding claims 2-3, as seen above, Liang teaches that the SGLT2 inhibitor is dapagliflozin or empagliflozin.
Regarding claims 4-5, Liang teaches that the pharmaceutical composition is administered as a solid oral dosage form such as a tablet or capsule (paragraph [0339]).
Regarding claim 6, Liang teaches that the pharmaceutical composition consists of a pharmaceutically acceptable carrier, excipient and/or diluent (paragraph [0035]).
Regarding claim 7, Liang teaches that the pharmaceutical composition comprises an effective amount of a GPR40 agonist and an effective amount of an SGLT2 inhibitor (paragraph [0039]). Liang further teaches that effective amount refers to an amount of an active compound or pharmaceutical agent that elicits the biological or medicinal response to alleviate the symptoms of the disease or disorder being treated (paragraph [0060]). Liang further teaches that the therapeutically effective amount includes a dose range from about 0.1 mg to about 3000 mg (paragraph [0346]).
While Liang does not teach the explicit ratio of instant claim 7, MPEP 2144.05 states: Generally, 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) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("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 Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art.").
As such, one of ordinary skill in the art would have been motivated to optimize the ranges taught by Liang.
Regarding claim 8, Kang teaches that the compound if instant formula 1 may be prepared by treatment of a free acid (paragraph [87]).
Regarding claim 10, Liang further teaches a process for making a pharmaceutical composition comprising a GPR40 agonist, an SGLT2 inhibitor; and a pharmaceutically acceptable carrier, a pharmaceutically acceptable excipient, and/or a pharmaceutically acceptable diluent (paragraph [0036]).
Claims 1 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Liang et al (US 2017/0290800 A1) in view of Kang et al (WO 2018/111012 A1), as applied to claims 1-8 and 10 above, and in further view of Kim et al (US 10,792,280 B2, published October 6th, 2020).
The 103 rejection of claims 1-8 and 10 over Liang and Kang above are incorporated herein by reference.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Neither Liang nor Kang teach that the method further comprises administering one or more additional drug.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art does not explicitly teach that the method includes administering one or more additional drugs.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
However, Kim teaches a method of treating type 2 diabetes that includes administering to the subject in need a biguanide drug selected from metformin, buformin and phenformin and also dapagliflozin or empagliflozin.
As Kim teaches that biguanide drugs, such as metformin, buformin and phenformin, also treat type 2 diabetes, one of ordinary skill in the art would have been motivated to form an additional composition for the same purpose. See MPEP 2144.06: "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious); and In re Couvaras, 70 F.4th 1374, 1378-79, 2023 USPQ2d 697 (Fed. Cir. 2023) (That the two claimed types of active agents, GABA-a agonists and ARBs, were known to be useful for the same purpose—alleviating hypertension—alone can serve as a motivation to combine).
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anna Grace Kuckla whose telephone number is (703)756-5610. The examiner can normally be reached Monday-Friday 7:30-5.
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/A.G.K./Examiner, Art Unit 1626
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699