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 07/06/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 1-4, 12, 17, 19-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rangnekar et al (Intl J of Pharmaceutics 570 (2019) 118689).
Rangnekar et al discloses powders formed by mixing bedaquiline with 0, 5%, and 20% L-leucine and combinations of bedaquiline, moxifloxacin, and pyrizasomode with 0, 5%, and 20% L-leucine in a co-solvent system of ethanol-water, mixing via sonification and moderate shaking, and then spray drying the combinations (pg 2, sec 2.3 Powder production by spray drying). It was found that 20% L-leucine provided the best aerosolization performance of the bedaquiline process (Id.). All the spray dried powders produced sphereical particles (pg 6, 3.2 Surface morphology).
With regards to claim 12, the particles were all about 2.0 µm in diameter (pg 6, sec 3.3 Particle size).
With regards to claim 17, the claimed method requires dissolving the two components in two solvents. As the process disclosed by Rangnekar et al includes an ethanol-water cosolvent system, it appears the instant limitation is satisfied where the two components are dissolved in two solvents, and mixed.
With regards to claim 21, the outlet temp of the spray drier was set between 47-53 oC (pg 3, left column, about lines 26-27).
Claim Rejections - 35 USC § 103
Claims 1-12 and 14-25 are rejected under 35 U.S.C. 103 as being unpatentable over Rangnekar et al (Intl J of Pharmaceutics 570 (2019) 118689) in view of Vehring (Pharmaceutical Particle Engineering via Spray Drying. Pharm Res 25, 999–1022 (2008)).
Rangnekar et al is discussed above but does not teach other excipients.
Vehring teaches it was well known to use dipalmitoylphosphatidycholine (DPPC) in combination with albumin and saccharides (pg 106, 2nd to last ¶). Also taught are phospholipids to formulate nanoparticles with actives incorporated in the continuous phase (pg 1007, right column, last ¶). Additional well materials include polylacide-co-glyco9lide and chitosan (pg 1008, right column, 2nd to last ¶). The use of organic solvents is taught (pg 108, left column, 2nd to last ¶).
It would have been obvious to one of ordinary skill in the art to modify the method of Rangnekar et al by using well known excipients for the spray dry process, such as taught by Vehring.
It would also have been obvious to use multiple excipients, where Vehring teaches spray drying formulations with multiple excipients. When combining the excipients, it would be obvious to optimize the various parameters, such as concentration and temperature to produce particles having a size and shape consistent with those taught by Rangnekar et al.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Rangnekar et al (Intl J of Pharmaceutics 570 (2019) 118689) in view of Vehring (Pharmaceutical Particle Engineering via Spray Drying. Pharm Res 25, 999–1022 (2008)) and Modi (US 6,294,153).
Rangnekar et al and Vehring are discussed above, but do not teach flavoring agents.
Modi teaches it was known to produce aerosols for pulmonary delivery comprising flavoring agents (claim 14).
It would have been obvious to add a flavoring agent, as taught by Modi, into the formulations made obvious by Rangnekar et al and Vehring where the resulting composition will have a better taste during administration.
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 9:30am-6:30pm + mid-day flex.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. 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
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