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
Pursuant to the preliminary amendment dated 4/25/2024, claim 10 is amended and claims 11-14 are newly added. No claims are canceled.
Claims 1-14 are pending in the instant application and are examined on the merits herein.
Priority
This application is a National Stage Application of PCT/KR2022/016601, filed on 10/27/2022. The instant application claims foreign priority to KR 10-2021-0144625 filed on 10/27/2021. Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). The certified copy has been filed in the instant application on 4/25/2024.
Information Disclosure Statement
The information disclosure statements (IDS) dated 4/25/2024, 5/28/2025 and 5/28/2026 comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609, except where noted. 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 § 112—Second Paragraph
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 7-9 are rejected for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 7 recites the limitation, “lowering blood pressure of an angiotensin receptor blocker”, which renders the claim and its dependents indefinite because an angiotensin receptor blocker does not have blood so blood pressure cannot be measured.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et al. (US 2020/0054656A1, Feb 2020, PTO-892).
Kim et al. discloses a orally administered pharmaceutical composition, for treating hypertension, comprising an SGLT-2 inhibitor, specifically dapagliflozin, and an angiotensin receptor blocker, specifically olmesartan, where dapagliflozin:olmesartan is exemplified in a ratio of 1:6.5 or 1:4. (Claims 1-8, Examples 1-2) Kim further discloses that: 1) the pharmaceutical composition of the present invention is effective not only for the treatment of hypertension, but also for the treatment of diabetes. Therefore, the pharmaceutical composition of the present invention may be used to treat both hypertension and diabetes, and thus the pharmaceutical composition of the present invention may be advantageously administered not only to hypertensive patients, but also to patients with both hypertension and diabetes. (¶0023); and 2) the pharmaceutical composition of the present invention may be formulated as sustained-release formulations or enteric-coated formulations so as to exhibit various drug release profiles, and may also be formulated into various dosage forms, including a single-layer tablet, a multi-layer tablet composed of two or more layers, a core tablet, and the like. (¶0027)
Accordingly, the instant claims are anticipated by the prior art.
Claims 1-9 and 11-13 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Jia et al. (US 2023/0346817A1, filed 2020, PTO-892).
Jia et al. exemplifies an orally administered multi-layer, adjuvant tablet composition, effective for treating hypertension, comprising an SGLT-2 inhibitor as active ingredient B, in a first layer, and an angiotensin receptor blocker (ARB), as active ingredient A, in a second layer, where SGLT2:ARB ratio is most preferably 50:4.1, 44.8:3.7, 32.5:2.7, 150:23.3, 75:12.3 (i.e. ~6:1 to 12:1). (Claims 1, 4-12 and 15; Examples 1-42) Jia discloses that active ingredient A is selected from the group consisting of irbesartan, candesartan, valsartan, telmisartan, losartan, iprasartan, olmesartan, azilsartan, and a mixture thereof and active ingredient B is selected from the group consisting of dapagliflozin, canagliflozin, empagliflozin, ipragliflozin, luseogliflozin, tofogliflozin, ertugliflozin, janagliflozin, bexagliflozin, sotagliflozin, henagliflozin, tianagliflozin, remogliflozin, alligliflozin, remogliflozin etabonate, (1R,2S,3S,4R,5S)-5-(4-chloro-3-(4-ethoxybenzyl)phenyl)-1-((R)-1-hydroxyethyl)-6,8-dioxabicyclo[3.2.1]octane-2,3,4-triol, and a mixture thereof. (Claim 1) Jia further discloses that the multi-layer, adjuvant tablet composition may be used in a method of treating hypertension and diabetes. (¶0006, 0013, 0052)
Accordingly, the instant claims are anticipated by the prior art.
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 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 of this title, 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.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 4-6 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 2020/0054656A1, Feb 2020, PTO-892).
The disclosure of Kim is referenced as discussed above. Kim does not exemplify or claim a composition which is formulated as a composite comprising a first agent and second agent.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the composition of Kim could be modified to be a composite tablet composed of multiple layers, where one layer comprises the SGLT-2 inhibitor and another layer comprises the angiotensin receptor blocker, because Kim suggests that the tablet may be formulated as a multi-layer tablet composed of two or more layers.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claims 10 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 2020/0054656A1, Feb 2020, PTO-892), in view of Shukla et al. (US 2020/0306231A1, PTO-892).
The disclosure of Kim is referenced as discussed above. Kim does not teach a food composition.
Shukla et al. discloses a food composition comprising SGLT2 inhibitors, such as dapagliflozin, and other active agents. (Claim 21)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the composition of Kim could be formulated as a food product, because Shukla teaches that it is known in the art to formulate therapeutic compositions comprising SGLT2 inhibitors as food products. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at ___, 82 USPQ2d at 1395; Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claims 10 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Jia et al. (US 2023/0346817A1, filed 2020, PTO-892), in view of Shukla et al. (US 2020/0306231A1, PTO-892).
The disclosure of Jia is referenced as discussed above. Jia does not teach a food composition.
Shukla et al. discloses a food composition comprising SGLT2 inhibitors, such as dapagliflozin, and other active agents. (Claim 21)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the composition of Jia could be formulated as a food product, because Shukla teaches that it is known in the art to formulate therapeutic compositions comprising SGLT2 inhibitors as food products. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at ___, 82 USPQ2d at 1395; Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claims 7-9 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 2020/0054656A1, Feb 2020, PTO-892), in view of Jia et al. (US 2023/0346817A1, PTO-892).
The disclosure of Kim is referenced as discussed above. Kim does not teach an adjuvant composition. The disclosure of Jia et al. is also referenced as discussed above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the composition of Kim could be formulated as a pharmaceutical adjuvant, because Jia teaches that it is known in the art to formulate therapeutic compositions comprising SGLT2 inhibitors and angiotensisn receptor blockers, as adjuvants. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at ___, 82 USPQ2d at 1395; Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DALE R MILLER whose telephone number is (571) 272-6146. The examiner can normally be reached on M-F 7:00 AM – 3:30 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached on (571) 270-5341. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DALE R MILLER/Primary Examiner, Art Unit 1693
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