DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The amendments received 06/16/2026 have been entered. Claims 1-13 are pending. Any objection or rejection previously set forth in the Office Action mailed 03/17/2026 not maintained herein has been overcome and is withdrawn.
New grounds for rejection are set forth herein, as necessitated by amendment.
Terminal Disclaimer
The terminal disclaimer filed on 06/16/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent number 11819549 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Information Disclosure Statement
The IDS filed 04/27/2026 has been considered by the Examiner. A signed copy is attached.
Specification
The disclosure is objected to because of the following informalities: paragraph [0064], Table 4, "Waster" should read "Water".
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 1-13 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.
Claim 1 has been amended to recite “adding a pharmaceutically acceptable acid in a fixed amount of 0.1 molar or 1.0 molar”. This causes confusion as the unit “molar” is a concentration rather than an “amount”. It is unclear what quantity is intended by the limitation “in a fixed amount of 0.1 molar or 1.0 molar”. Is the “0.1 molar or 1.0 molar” the fixed amount? If so, no actual “amount” is specified. Is a fixed amount of a 0.1 molar or 1.0 molar solution of a pharmaceutically acceptable acid being added to the solution of ciclesonide and ethanol? Clarification is required. Claims 2-13 do not clarify the limitation at issue and are also rejected.
Conclusion
No claims are allowed.
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 MADELINE E BRAUN whose telephone number is (703)756-4533. The examiner can normally be reached M-F 8:30am-5:00pm ET.
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/M.E.B./Examiner, Art Unit 1624 06/23/2026
/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624
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