Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 16/797163 (PAT 10610489), fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Application 16/797163 does not appear to provide adequate support for the specific combination of empagliflozin and metformin. Accordingly, this application does not have the priority filing date of application 16/797163.
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 1, 2, 9-11 and 13-16 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 1 and 2 recited the limitation “a pharmaceutical composition comprising empagliflozin, metformin, and one or more pharmaceutical excipients or a pharmaceutical dosage form comprising said pharmaceutical composition.” Is metformin required in the pharmaceutical composition here? First, there was no “and” or “combination” or “mixture” to indicate that both empagliflozin and metformin are required in the composition. Second, the phrase one or more pharmaceutical excipients or a pharmaceutical dosage form comprising said pharmaceutical composition makes the claims unclear as to whether or not both active agents are required.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 1-11 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Manuchehri et al. US 2016/0030385 A1, in view of Friedl et al. US 9,155,705 B2.
This rejection has been withdrawn in view of the Amendment filed 03/04/2026.
Claims 1, 2, 9-11 and 13-16 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Mayoux et al. AU 2013237557 B2, in view of Manuchehri et al. US 20160030385 A1.
Mayoux teaches a method and/or use according to this invention is advantageously applicable in those patients who show one, two or more of the following conditions: (a) insufficient glycemic control with diet and exercise alone; (b) insufficient weight control despite therapy with an antiobesity drug; (c) insufficient weight control despite therapy with empagliflozin; (d) insufficient glycemic control despite oral monotherapy with metformin, in particular despite oral monotherapy at a maximal recommended or tolerated dose of metformin. Furthermore, the method or use according to this invention is advantageously applicable in those patients who show one, two or more of the following conditions: (a) a fasting blood glucose or serum glucose concentration greater than 100 mg/dL, in particular greater than 125 mg/dL; (b) a postprandial plasma glucose equal to or greater than 140 mg/dL; (c) an HbA1 c value equal to or greater than 6.5 %, in particular equal to or greater than 7.0 %, especially equal to or greater than 7.5 %, even more particularly equal to or greater than 8.0 %. See page 19. Therefore, a particularly preferred embodiment of the present invention provides a method for therapy, preferably oral therapy, for improvement, especially long term improvement, of glycemic control in patients with pre-diabetes or type 2 diabetes mellitus in particular in patients additionally diagnosed of overweight, obesity (including class I, class II and/or class III obesity), visceral obesity and/or abdominal obesity. See page 20. According to one embodiment empagliflozin and the one or more antiobesity drugs are administered in combination, i.e. simultaneously, for example in one single formulation or dosage form or in two separate formulations or dosage forms, or in alternation or sequentially, for example successively in two separate formulations or dosage forms. Hence, the administration of one combination partner, i.e. empagliflozin or the one or more antiobesity drugs, may be prior to, concurrent to, or subsequent to the administration of the other combination partner. In one embodiment, for the combination therapy according to this invention empagliflozin and the one or more antiobesity drugs are administered in different formulations or different dosage forms. In another embodiment, for the combination therapy according to this invention empagliflozin and the one or more antiobesity drugs are administered in the same formulation or in the same dosage form. See page 20, last paragraph. Preventing manifest type 2 diabetes mellitus mellitus is found in Examples 3-4.
Mayoux does not expressly teach combination with a second drug that includes metformin.
Manuchehri teaches a method for treating metabolic disorder selected from the group consisting of type 1 diabetes mellitus, type 2 diabetes mellitus, impaired glucose tolerance, hyperglycemia, postprandial hyperglycemia, overweight, obesity, including class I obesity, class II obesity, class III obesity, visceral obesity and abdominal obesity, and the metabolic syndrome. See paragraphs 0029-0031 and 0054-0056. The method comprises administering to a patient in need thereof a composition comprising SGLT-2 inhibitor and a biguanide such as metformin. See abstract, paragraphs 0057, 0141 and 0153-0158. The composition can be formulated into oral dosage form including tablet. See paragraph 0160. Dosing amounts of SGLT-2 inhibitor and metformin are found in paragraphs 0161 and 0180, respectively. Example A, shows tablet with no ingredients added that would retard release, therefore this is an immediate release tablet that is monolayer.
Thus, it would have been prima facie obvious for one of ordinary skill in the art to, by routine experimentation combining empagliflozin and metformin given the teachings in Mayoux and Manuchehri with the expectation to obtain a composition useful for the treatment of metabolic disorder and/or to improve glycemic control. This is because Mayoux teaches the desirability for combining empagliflozin with a partner drug for the treatment of type 2 diabetes mellitus, and similarly, Manuchehri teaches combination of emagliflozin with a partner drug that includes metformin for the same treatment. Moreover, one of the skills in the art would have been motivated to combine empagliflozin and metformin in view of the teaching in Manuchehri because Manuchehri teaches combining empagliflozin and metformin is known in the art.
Response to Arguments
Applicant’s arguments filed 03/04/2026 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSAN T TRAN whose telephone number is (571)272-0606. The examiner can normally be reached Monday-Friday, 8:30 am-5:30 pm.
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/SUSAN T TRAN/Primary Examiner, Art Unit 1615