DETAILED ACTION
1. Claims 1, 4-5, 7, 9-10, 15-18, 20, 30, 44, 54, 73, 76, 79, 136-137, 153 are pending in the instant application.
2. The rejection of claim 137 under 35 U.S.C. 112, first paragraph is withdrawn in view of applicant’s amendment and argument in paper dated on 06/02/2026.
3. The rejection of claims 1, 4-5, 7, 9-10, 15-18, 20, 30, 44, 54, 73, 76, 79, 136-137, 153 under 35 U.S.C. 103(a) over Keswani et al., US 2016/0220710 and Fink et al., US 7,971,588 is maintained for reason of record.
Applicants argue that just because two compounds may have similar uses, that does not alone suggest that they would be combined together to provide a composition that is efficacious and beneficial. The amended claims recite that clofazimine is deposited on the surface of the amikacin. Such a structure configuration is not the result of merely physical mixing the two drug, and is nowhere suggested in either Keswani et al. or Fink et al.
It is Examiner’s position that the combination of Clofazimine and amikacin can be used to treat lung disease. Clofazimine and amikacin show significant activity against both rapidly and slowly growing nontuberculous mycobacteria. The combination of Clofazimine and amikacin increase the antimycobacterial activity of the intensive phase of treatment. They increase influx of amikacin, possibly by attaching to clofazimine. (Ingen et al., Antimicrobial Agents and Chemotherapy, 2012, volume 56, Number 12, pages 6324-6327). Therefore, it is obvious that clofazimine is deposited on the surface of the amikacin to treat diseases.
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 extension fee 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 date of this final action.
4. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Niloofar Rahmani whose telephone number is
571-272-4329. The examiner can normally be reached on Monday through Friday from 8:30 am to 5:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor, can be reached on 571-272-8394. The fax phone number for the organization where this application or proceeding is assigned is 703-872-9306.
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/NILOOFAR RAHMANI/
06/11/2026
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