DETAILED ACTION
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 .
Applicants' arguments, filed 11/17/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 2-4 stand rejected under 35 U.S.C. 102(a)(1) as being anticipated by Azevedo et al (WO2018/076090).
Applicants assert the prior art does not teach the use of the compound for the treatments instantly claimed.
Examiner disagrees. As previously noted, claims 2-4 are directed to a compound and composition comprising the compound. The MPEP notes that the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer. See MPEP 2112(I). Here, the claimed compound inherently has the ability to treat the listed conditions, but the conditions need not be recognized by the prior disclosure. See MPEP 2112(II). Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. See MPEP 2112.01(I and II)
In other words, the compound and composition are simply those, compounds and compositions. Adding intended uses or other labels do not render the compound per se non-anticipated over the prior art.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 5 stands rejected under 35 U.S.C. 103 as being unpatentable over Azevedo et al (WO2018/076090) in view of Ohkawa (US 6,034,239).
Applicants present no arguments with regards to Ohkawa, therefore this rejection is maintained for reasons recited above.
Claims 6-7 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Azevedo et al (WO2018/076090) in view of Ohkawa (US 6,034,239), Univ Granda (ES 2711808), and Karamitri et al (Nature Reviews, v15, no2, 2018, 105-125).
Azevedo et al was previously discussed and teaches the compounds show high affinity for the melatonergic receptors, MT1 and MT2 (pgs 77-79, sections 2.1-2.2, and table 1).
Ohkawa is discussed above for teaching salts of pharmaceuticals were well known.
Univ Granda teaches melatonin receptor agonists are useful for treatment of diseases, such as obesity and diabetes (pg 6, lines 2-24).
Karamitri et al teaches melatonin is useful in treating patients with obesity, diabetes, non-alcoholic fatty liver disease, and non-alcoholic steatohepatitis (table 1).
It would have been obvious to one of ordinary skill in the art to use the melatonergic receptors agonists of the primary reference for any known treatment that is accomplished by administration of melatonergic receptors agonists, such as those disclosed in Univ Granda and Karamitri et al
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN J PACKARD whose telephone number is (571)270-3440. The examiner can normally be reached Mon 2-6pm and Tues-Fri (9am-6pm + mid-day flex).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sandy Kaup can be reached at (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BENJAMIN J PACKARD/ Primary Examiner, Art Unit 1612