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 .
Claims 1, 7-9, 14-23, 27-31 and 36 are presented for examination.
Applicants’ drawings filed February 27, 2023 have been received and entered.
Applicants’ preliminary amendments filed February 27, 2023 and December 3, 2025 have been received and entered.
Applicants’ information disclosure statement filed March 10, 2023 has been received and entered.
Applicants’ election filed December 3, 2025 in response to the restriction requirement of July 17, 2025 has been received and entered. The applicants elected the invention described in claims 1, 7-9, 14-23 and 36 (Group I) with traverse. Applicants’ traverse is noted, but is not deemed persuasive for reasons set forth in the previous Office action dated July 17, 2025; therefore, the restriction requirement is hereby made Final.
Claims 27-31 are withdrawn from consideration as being drawn to the non-elected invention (37 CFR 1.142(b)).
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Claim Rejections - 35 USC § 102
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 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)(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.
Claim(s) 1, 7-14, 23 and 36 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2010/092163 A2, hereby known as Graefe-Mody et al., taken in evidence with SED Pharma, “Exploring Different Types of Tablets in Pharmacy (2026).
Graefe-Mody et al. teach antidiabetic medications comprising a pharmaceutical composition comprising: a) a DPP-4 inhibitor, and b) a second antidiabetic agent selected from biguanides (particularly metformin), and c) a third antidiabetic agent selected from sulfonylureas (see page 5, lines 3-12 and page 80, claims 1-2).
Note page 1, under Technical Field of the Invention, the antidiabetic medication comprising the said pharmaceutical composition is used in the treatment of type 2 diabetes mellitus (control and management).
Note page 32, lines 10-11,and page 81, claim 7, the DPP-4 inhibitor is selected from vildagliptin.
Note page 33, lines 18-19, the second antidiabetic agent selected from biguanides, preferably metformin (line 24).
Note page 34, lines 17-18, the third antidiabetic agent selected from sulfonylureas, such as glimepiride.
Note page 51, lines 17-23 teaches the dosage amounts of vildagliptin is from 10 to 150 mg daily, in particular from 25 to 150 mg, 25 and 100 mg or 25 and 50 mg or 50 and 100 mg daily. For example, the daily administration is 50 or 100 mg.
Note page 52, lines 25-30 teaches the dosage amounts of metformin is from 250 to 3000 mg, in particular 500 to 2000 mg per day. The preferred range of amounts are 250 to 1000 mg, in particular 500 to 1000 mg. For example, the daily administration is 500, 750 and 850 mg.
Note page 53, lines 25-27 teaches the dosage amounts of glimepiride is from 0.5 to 10 mg, in particular 1 to 6 mg per day. The preferred range amounts are 0.5 to 10 mg. For example, 1, 2, 3, 4, and 6 mg.
Note page 59, lines 20-23 teaches the pharmaceutical composition may be formulated in the form of tablets (conventional), granules, caplets, and pills.
Note page 60, lines 4-5 teaches the tablets may contain conventional excipients such as binding agents, fillers, lubricants, disintegrants, or wetting agents. The tablets may be coated according to methods well-known in the art.
Note page 60, lines 28-33 to page 61, lines 1-21 for the types of binding agents, fillers, lubricants, disintegrants, or wetting agents.
The SED Pharma is cited to show the conventional tablets are also known as immediate-release tablets in the pharmaceutical art.
Clearly, the cited reference, Graefe-Mody et al, anticipates applicants’ instant combination drug; therefore, applicants’ instant combination drug is unpatentable.
Claims 1, 7-14, 23 and 36 are not allowed.
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, 7-9, 14-23 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2010/092163 A2, hereby known as Graefe-Mody et al. in view of Rowe et al., HANDBOOK OF PHAMCEUTICAL EXCIPIENTS,6th Edition, pages 1-917 (2009) and further in view of EP 1208143 B1, hereby known as Jordan et al.
Graefe-Mody et al. were discussed above supra for an antidiabetic medications comprising a pharmaceutical composition comprising: a) a DPP-4 inhibitor, and b) a second antidiabetic agent selected from biguanides (particularly metformin), and c) a third antidiabetic agent selected from sulfonylureas and for the treatment of type 2 diabetes mellitus (control and management) may be formulated in the form of tablets (conventional), granules, caplets, and pills. Wherein the tablets may contain conventional excipients such as binding agents, fillers, lubricants, disintegrants, or wetting agents. The tablets may be coated according to methods well-known in the art.
The instant invention differs from the cited reference in that the cited reference does not teach applications’ preferred diluent, disintegrant, absorbent, binder, solubilizer, lubricant, and coating for a moisture and light barrier (applicants’ claims 15-22). However, the secondary reference, Rowe et al., teaches the applicants’ preferred diluent, disintegrant, absorbent, binder, solubilizer, and lubricant, to formulate tablets are well-known in the art. The tertiary reference, Jordan et al., teaches the film coating of pharmaceutical tablets with the high- performance barrier coating is well-known in the art.
Claims 1, 7-9, 14-23 and 36 are not allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN E WEDDINGTON whose telephone number is (571)272-0587. The examiner can normally be reached M-F 1:30-10:00.
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KEVIN E. WEDDINGTON
Primary Examiner
Art Unit 1629
/KEVIN E WEDDINGTON/Primary Examiner, Art Unit 1629