The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
CONTINUING DATA
This application is a CON of 17/073,827 10/19/2020 ABN
17/073,827 is a CON of 16/658,542 10/21/2019 ABN
16/658,542 is a CON of 15/902,643 02/22/2018 ABN
15/902,643 is a CON of 14/949,986 11/24/2015 ABN
14/949,986 is a CON of 13/484,506 05/31/2012 ABN
FOREIGN APPLICATIONS
EP 11168641.6 06/03/2011
EP 12153052.1 01/30/2012
This office action is in response to Applicant’s amendment submitted June 12, 2026. Claims 1, 4-12, 15-18, 21-25, 28-32, and 35-37 are pending.
The rejection of claim 12 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is withdrawn because the narrower limitations were removed from claim 12.
The rejection of claim(s) 1, 4-5, 7-9, 18, 21-22, 24-26, 28-29, 31-32, and 35-36 is/are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Keil is withdrawn because Keil does not teach the method using the compound of claim 1 (previously in claim 3, which was not rejected over Keil).
The terminal disclaimer filed June 12, 2026 is sufficient to overcome the double patenting rejections made in the previous office action.
The following rejection is maintained.
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 of this title, 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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1, 4-12, 15-18, 21-25, 28-32, and 35-37 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lieberman (Prim Care Companion J Clin Psychiatry 2004;6 (suppl 2), pp. 8-13) and Wu et al. (JAMA, January 9/16 2008 – Vol 299, No. 2, pp. 185-193) in view of Himmelsbach et al. (CA 2557801, October 2005).
Lieberman teaches that the use of antipsychotics is associated with weight gain, impaired glucose metabolism, exacerbation of existing type I and type 2 diabetes, new onset of type 2 diabetes, and diabetic ketoacidosis, and increases the probability of metabolic syndrome. See paragraph bridging pages 8-9. Features of Metabolic Syndrome include impaired glucose metabolism or diabetes, obesity, raised blood pressure, raised plasma triglyceride and LDL levels, and low HDL cholesterol levels. See Table 1. Hyperglycemia and impaired glucose levels are often seen in patients suffering from diabetes or metabolic
syndrome. Atypical antipsychotics can increase the risk of hyperglycemia and impaired glucose levels and subsequently increase the risk of metabolic syndrome. Page 9, Hyperglycemia and Glucose Levels. Antipsychotics include conventional antipsychotics, clozapine, risperidone (a benzisoxazole), quetiapine, or olanzapine. See page 11, top of second column. The induction of obesity by antipsychotic agents has been documented for many years. See introduction.
Wu also teaches that weight gain is a common adverse effect of antipsychotic medications and is associated with medical comorbidities, such as weight gain, hyperlipidemia, and glucose intolerance. See page 185, context. Wu teaches that metformin was effective for treating antipsychotic-induced weight gain. See page 185, Conclusions. Antipsychotics include clozapine, olanzapine, quetiapine, risperidone, ziprasidone, and apriprazole. See paragraph bridging pages 185-186.
Lieberman and Wu do not teach administration of an SGLT2 inhibitor with the neuroleptic agent.
Himmelsbach teaches the use of the following SGLT2 inhibitors for treating metabolic disorders. See abstract.
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A preferred compound is the following, recited on page 29 and illustrated on page 74. This preferred compound is empagliflozin.
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The metabolic disorders to be treated include diabetes, metabolic syndrome, insulin resistance, and obesity. See page 46. Additional therapeutic agents such as metformin may be included. See page 47.
It would have been obvious to one of ordinary skill in the art to administer an SGLT2 inhibitor to treat a metabolic disorder in a patient being treated with a neuroleptic agent, such as a patient being treated for a psychotic disorder. Metabolic disorders which are common in patients who are taking antipsychotics include weight gain, type 2 diabetes, hyperglycemia, and metabolic syndrome. SGLT2 inhibitors are known for treating metabolic disorders such as diabetes, metabolic syndrome, and obesity. The skilled artisan would have administered SGLT2 inhibitors to patients taking neuroleptics because SGLT2 inhibitors treat the metabolic disorders that neuroleptics cause. Metformin has been used to treat weight gain in patients taking antipsychotics and metformin is also used in combination with SGLT2 inhibitors. The skilled artisan would have had a reasonable expectation of success in replacing metformin with an SGLT2 inhibitor or combining the metformin with an SGLT2 inhibitor because they are used for the same purpose and are known to be used in combination. The administration would have been in combination, or alternation, or sequential because there is no other way to administer two different drugs.
Response to Arguments
Applicant argues that the combination of Wu and Lieberman does not suggest SGLT2 inhibitors such as those described in Himmelsbach. This argument is not persuasive because Wu and Lieberman teach that neuroleptic agents cause obesity, metabolic syndrome, etc., and Himmelsbach teaches that SGLT2 inhibitors treat those very conditions. The motivation to use SGLT2 inhibitors is found in the combination of Wu and Lieberman with Himmelsbach.
Applicant argues that Wu only teaches the use of metformin, which is different from SGLT2 inhibitors. This argument is not persuasive because Himmelsbach teaches that SGLT2 inhibitors treat metabolic syndrome, etc., and that they can be used in combination with metformin. The skilled artisan would have used an SGLT2 inhibitor alone because SGLT2 inhibitors treat metabolic syndrome, etc. as discussed in the preceding paragraph. The skilled artisan would have used the combination of SGLT2 inhibitors and metformin because SGLT2 inhibitors can be used along with metformin, and each treats the same disorders.
Applicant argues that the skilled artisan would have had to choose the compound recited in claim 1 from hundreds of thousands of compounds taught by Himmelsbach, or from a list of 17 preferred compounds. This argument is not persuasive because Himmelsbach teaches that the claimed compound is a preferred compound. Applicant argues that Himmelsbach does not teach, anywhere, that the claim 1 compound is a more preferred compound. MPEP 2143 states that an example of rationales that support a conclusion of obviousness includes choosing from a finite number of identified, predictable solutions with a reasonable expectation of success. 17 compounds is a finite number, and the results would have been predictable because all are of the same class and are all taught to be useful for treating metabolic syndrome, obesity, etc.
It is noted that the examiner reviewed the current specification and did not find any evidence of unexpected results which could overcome the rejection.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAYLA D BERRY whose telephone number is (571)272-9572. The examiner can normally be reached on 7:00-3:00 CST, M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached on 571-270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAYLA D BERRY/Primary Examiner, Art Unit 1693
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