DETAILED ACTION
Claims 2, 4, 7, 10-11, 14-15, 20-22, 26, 39-41, 43-45, 48 are pending in the instant application.
The rejection of claims 2, 4, 7, 10-11, 14-15, 20-22, 26, 39-41, 43-45, 48 under 35 U.S.C. 102(a)(1) and 102(a)(2) over Small et al., WO 2009127878 is maintained for reason of record.
Applicants argue that Small et al. relates to a non-pressurized pharmaceutical liquid solution spray formulation comprising: (i) buprenorphine; (ii) a solvent comprising ethanol; and (iii) one or more antioxidants each of a molar ratio of antioxidant: buprenorphine between 0.2:1 and 25:1.
It is Examiner’s position that et al. discloses the compound buprenorphine on page 3. The compound buprenorphine combines with antioxidants include (BHA) and (BHT) on page 5. The above formulation can be d to treat pain on page 16. Small discloses the most common formulation of buprenorphine is sublingual tablets containing 0.4, 2 and 8 mg buprenorphine hydrochloride on page 2. Therefore, the rejection is maintained.
The rejection of claims 2, 4, 7, 10-11, 14-15, 20-22, 26, 39-41, 43-45, 48 under 35 U.S.C. 102(a)(1) and 102(a)(2) over Booles et al., US 2009/0270438 is maintained for reason of record.
Applicants argue that Booles et al. relates to a non-pressurized pharmaceutical liquid solution spray formulation comprising: (i) buprenorphine; and a solvent comprising ethanol which composition is substantially free of chloride.
It is Examiner’s position that et al. discloses the compound buprenorphine on abstract. The compound buprenorphine combines with antioxidants include (BHA) and (BHT) on page 3, paragraph 555. The above formulation can be d to treat pain on page 1. Booles discloses the most common formulation of buprenorphine is sublingual tablets containing 0.4, 2 and 8 mg buprenorphine hydrochloride on page 1. Therefore, the rejection is maintained.
The rejection of claims 2, 4, 7, 10-11, 14-15, 20-22, 26, 39-41, 43-45, 48 under 35 U.S.C. 102(a)(1) and 102(a)(2) over Amancha et al., US 9,216,175 is maintained for reason of record.
Applicants argue that Amancha et al. relates to a non-pressurized pharmaceutical liquid solution spray formulation comprising (i) buprenorphine, a pharmaceutically acceptable salt thereof, or a derivative thereof.
It is Examiner’s position that et al. discloses the compound buprenorphine on abstract and column 1. The compound buprenorphine combines with antioxidants include (BHA) and (BHT) on column 3 and 49. The above formulation can be d to treat pain on page 1. Amancha discloses the pharmaceutically acceptable salts that can be used with the current inventio include hydrochloride and it is preferred on column 7. Therefore, the rejection is maintained.
The rejection of claims 2, 4, 7, 10-11, 14-15, 20-22, 26, 39-41, 43-45, 48 under 35 U.S.C. 102(a)(1) and 102(a)(2) over Amancha et al., US 9,918,981 is maintained for reason of record.
Applicants argue that Amancha et al. relates to a non-pressurized pharmaceutical liquid solution spray formulation comprising (i) buprenorphine, a pharmaceutically acceptable salt thereof, or a derivative thereof.
It is Examiner’s position that et al. discloses the compound buprenorphine on abstract and column 1. The compound buprenorphine combines with antioxidants include (BHA) and (BHT) on column 3 and 10. The above formulation can be d to treat pain on abstract. Amancha discloses pharmaceutically acceptable salts that can be used with the current inventio include hydrochloride and it is preferred on column 9. Therefore, the rejection is maintained.
THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicants are reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for replying 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.
7. 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/ Primary Examiner, Art Unit 1691
08/25/2026
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