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 .
Restriction/Election
Applicant’s election without traverse of Group I, claims 1-7 in the reply filed on 12/29/2025 is acknowledged.
Claims 8-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/29/2025.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4 and 5 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 4 and 5 are rejected in using improper Markush language. The addition of the phrase “group consisting of” after “from” in line 2 will overcome the rejection.
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.
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) 1-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abebe et al. (Us 20150238421) in view of MacMahon et al. (20200206246).
The claims are drawn to an oral complex tablet, comprising: a first layer comprising: dry granules containing sitagliptin or a pharmaceutically acceptable salt thereof, or a hydrate thereof, and dapagliflozin or a pharmaceutically acceptable salt thereof, or a hydrate thereof, and colloidal silicon dioxide; and a second layer comprising wet granules containing metformin or a pharmaceutically acceptable salt thereof,
wherein the colloidal silicon dioxide is contained in an amount of 0.5 to 2% by weight based on the total weight of the first layer.
Regarding claim 1, Abebe teaches a bilayer tablet comprising: (1) a first layer wherein the first layer is a metformin hydrochloride extended release formulation; (2) a second layer wherein the second layer is a (SGLT2 inhibitor) formulation comprising dapagliflozin, dapagliflozin (S) propylene glycol hydrate, dapagliflozin (R) propylene glycol hydrate or canagliflozin. See Para [0008] and claim 1. The use of silicone dioxide in layers 1 and 2 is taught in Para [0009] and claim 2. Abebe teaches the use of sitagliptin as a compound, which can be used in combination with metformin and dapagliflozin in Para [0117]. Claim 1 is also drawn to a second layer comprising wet granules containing metformin. Abebe teaches that Metformin HCl, 0.5% magnesium stearate, and sodium carboxymethyl cellulose were combined and mixed into a high shear granulator for one minute. Purified water, using a nozzle, was added with stirring for one minute. The wet granulated material was passed through a mill and then dried until the moisture content was 1.0% or less. The dried material containing metformin HCl, 0.5% magnesium stearate, and sodium carboxymethyl cellulose was passed through a mill and discharge into polyethylene-lined drums to provide milled metformin 1 g bulk granulation. Such teaching reads on the wet granules of the second layer. See Para [0166]. Abebe teaches that Second Layer has the concentration of Silicon Dioxide 1.50%. See table 1. Such concentration is within the scope of the claimed concentration of 0.5-2%. Claim 1 is also directed to a first layer comprising dry granules containing dapagliflozin and sitagliptin. Abebe further teaches Dapagliflozin (S) PGS was blended with microcrystalline cellulose, anhydrous lactose, a portion of crospovidone, and a portion of silicon dioxide in a suitable tumble mixer and passed through a suitable conical mill. A portion of magnesium stearate (screened) was blended into the mixture and then compacted using an appropriate roller compactor. The compacted mixture was reduced to form granules. The granules were blended with the remaining amount of crospovidone and silicon dioxide in a suitable tumble mixer. The granules were then blended with the remaining amount of magnesium stearate in a suitable tumble mixer. See Para [0169]. Such teachings read on the dry granules of first layer.
Abebe teaches the addition of sitagliptin to the tablet, but does not teach the use of sitagliptin in the first layer. However, the determination of using the ingredients in different layers would have been obvious to a person skilled in the art in the absence of evidence to the contrary.
Regarding claim 2, Abebe does not teach the use of sitagliptin phosphate and dapagliflozin propanediol. MacMahon et al. teach pharmaceutical compositions that are useful for the treatment of diabetes and associated conditions, diseases, and disorders. See the abstract. the use of metformin is taught in Para [0025]. The use of dapagliflozin propanediol is taught in paras [0026], [0090] and claim 38. The use of sitagliptin phosphate is taught in claim 40.
It would have been obvious to a person skilled in the art to incorporate dapagliflozin propanediol and sitagliptin phosphate into the composition of Abebe, motivated by the teachings of MacMahon, which teaches the use of dapagliflozin propanediol and sitagliptin phosphate in combination with metformin in an anti-diabetic composition in a tablet form as old and well known.
Regarding claim 3, Abebe teaches a bilayer tablet comprising: (1) a first layer wherein the first layer is a metformin hydrochloride extended release formulation; (2) a second layer wherein the second layer is a (SGLT2 inhibitor) formulation comprising dapagliflozin. See claim 1.
Regarding claim 4, Abebe teaches a bilayer tablet comprising a first layer wherein the first layer is a metformin hydrochloride extended release formulation comprising metformin hydrochloride, sodium carboxymethyl cellulose; hydroxypropyl methylcellulose; magnesium stearate; and optionally silicon dioxide or colloidal silicon dioxide. See claim 4.
Regarding claim 5, Abebe teaches the second layer comprises two or three fillers selected from lactose anhydrous, microcrystalline cellulose, pregelatinized starch, mannitol, and hydroxypropyl cellulose; a disintegrant that is crospovidone; a glidant that is silicon dioxide; and a lubricant that is magnesium stearate. See claim 4.
Regarding claim 6, the determination of total content of dapagliflozin and sitagliptin after being stored under harsh conditions for 4 weeks is considered to be within the skill of artisan in the absence of evidence to the contrary. Further, since the relied upon references teach the combination of dapagliflozin, sitagliptin and metformin in a tablet, therefore the content of such components under the harsh conditions for 4 weeks is the inherent property of the prior art composition. Applicant’s attention is drawn to In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990), where the court states “products of identical chemical composition cannot have mutually exclusive properties”. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Regarding claim 7, Abebe teaches the concentration of metformin being 1000mg, the concentration of dapagliflozin being 0.5-4%, which is 5-40 mg. Such amounts overlap with the claimed amounts. Abebe does not teach the concentration of sitagliptin being 25-100 mg. However, MacMahon teaches pharmaceutical compositions that are useful for the treatment of diabetes and associated conditions, diseases, and disorders. See the abstract. the use of metformin is taught in Para [0025]. The use of dapagliflozin propanediol is taught in paras [0026], [0090] and claim 38. The use of sitagliptin phosphate is taught in claim 40. McMahon teaches the dose of sitagliptin is about 25 mg, which reads on the lower limit of the claimed concentration of 5-100 mg. See tables 2 and 5.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZOHREH A FAY whose telephone number is (703)756-1800. The examiner can normally be reached Monday-Friday 9:30AM-6:00.
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/ZOHREH A FAY/Primary Examiner, Art Unit 1617