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 .
Claims 1-7, 9, 11, 12, 14-19, 23-26 and 30-37 are presented for examination.
Applicant’s amendments and response filed March 6, 2026 have been received and entered.
Applicant’s information disclosure statement filed March 18, 2026 has been received and entered.
Accordingly, the rejection made under 35 USC 112(a) or 35 USC 112 (pre-AIA ), first paragraph (Written Description) as set forth in the previous Office action dated December 29, 2025 at pages 2-4 as applied to claims 9 and 11-21 is hereby WITHDRAWN due to applicant’s amendment to claims 9 and 11.
Accordingly, the rejection made under 35 USC 112(b) or 35 USC 112 (pre-AIA ), second paragraph as being indefinite for failing to particularly point and distinctly claim the subject matter as set forth in the previous Office action dated December 29, 2025 at pages 4-5 as applied to claims 9-22 is hereby WITHDRAWN due to applicant’s amendment to claims 9 and 11.
Accordingly, the rejection made under 35 USC 102(a)(1) as being anticipated by Ifantides (11,738,022 B2) as set forth in the previous Office action dated December 29, 2025 at pages 5-6 as applied to claims 1, 4 and 23-26 is hereby WITHDRAWN due to applicant’s amendment to claims 1, 4 and 23-26 to recite the critical limitation, “orally or parenterally administered”. The prior art does not teach the preferred modes of administration to the patient.
Accordingly, the rejection made under 35 USC 103 as being unpatentable over WO 2018/126182 A1, hereby known as Nandabalan et al. in view of Pasinetti (US 2010/0029654 A1) as set forth in the previous Office action dated December 29, 2025 at pages 6-8 as applied to claims 1,2,4-15 and 17-26 is hereby WITHDRAWN due to applicant’s remarks.
Allowable Subject Matter
Claims 1, 3-7, 9, 11, 12, 14, 16-19, 23-26, 30, 31 and 33-37 are allowable.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 2, 15 and 32 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a New Matter rejection.
The instant specification does not disclose the specific dosage range of dexmedetomidine, or the pharmaceutically acceptable salt is “80 micrograms to 2400 micrograms”. The instant specification shows the ranges of “240 micrograms to 2400 micrograms” on page 18, section [0052].
Claims 2, 15 and 32 are not allowed.
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 KEVIN E WEDDINGTON whose telephone number is (571)272-0587. The examiner can normally be reached M-F 1:30-10:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeff Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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KEVIN E. WEDDINGTON
Primary Examiner
Art Unit 1629
/KEVIN E WEDDINGTON/Primary Examiner, Art Unit 1629