DETAILED ACTION
Claims 9-10, 13-16 and 21, submitted 15 May 2026, are pending in the application. Claims 13-16 and 21 are under examination in the instant Office Action. Claims 17-20 have been cancelled by the Applicant. Claims 9-10 remain withdrawn.
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 .
EXAMINER’S NOTE
The Examiner regrets to inform the Applicant of the rescinding of the notice of allowable subject matter. During examination, an error was made on behalf of the Examiner and, after careful consideration, the claimed limitations do not meet all of the requirements of allowable subject matter.
Rejections – Modified
The status of the rejected claims of the previous Office Action is set out below.
Rejections under 35 U.S.C. §103
The Applicant’s amendments to claim 13 is not sufficient to overcome the rejections in the previous Office Action.
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.
Modified - Claims 13-16 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Narang et al. (US PG-PUB 2013/0224296 A1).
Narang teaches a pharmaceutical composition comprising a tablet core that
comprises a binder, wetting agent, a lubricant, and at least one antidiabetic or pharmaceutically acceptable salt thereof, wherein the antidiabetic is metformin (paragraph 0052). In that same paragraph, Narang teaches wherein a first layer coats the tablet core and comprises at least one water soluble antioxidant. This reference additionally teaches wherein a variety of water-soluble antioxidants can be used including ascorbic acid, propyl gallate, sodium sulfite, sodium metabisulfite, and sodiumbisulfite (paragraph 0030). Narang does not teach wherein the antioxidants used are an inhibitor of N-nitrosodimethylamine, however, the specification teaches wherein sodium metabisulfite and sodium dithionite are antioxidants on page 5 in Example 2. Thus, the pharmaceutical composition taught by Narang reads on the limitations of the instant claims.
Additionally, Narang teaches what is essentially an identical composition to that of the Applicant’s, said composition comprising metformin and an N-nitrosodimethylamine inhibitor, propyl gallate. As the compositions are identical, logic would follow that the pharmaceutical composition would comprise less than 40 ng N-nitrosodimethylamine regardless of whether the propyl gallate was in the composition for a materially different reason.
With respect to claim 14, Narang teaches wherein a variety of water-soluble antioxidants can be used to include ascorbic acid, propyl gallate, sodium sulfite, sodium
metabisulfite, and sodium bisulfite (paragraph 0030).
With respect to claim 15, Narang teaches wherein the composition comprises excipients where the excipients comprise a binder, a filler, a lubricant, or a release modifier shown in Table 14 below.
Table 14 (pg.18-19)
PNG
media_image1.png
288
512
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Greyscale
Regarding claim 21, Narang teaches wherein the API comprises metformin hydrochloride (paragraph 0077).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN CHRISTOPHER SANCHEZ whose telephone number is (703)756-5336. The examiner can normally be reached Monday -Friday (0730-1700).
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JUSTIN CHRISTOPHER SANCHEZ
Examiner
Art Unit 1622
/J.C.S./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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