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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 06/03/2024 has been entered.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 17, 18 and 20-27 are rejected under 35 U.S.C. 103 as being unpatentable over Nyambura et al. US 2021/0386666 A1, in view of Piskorz US 20120042886.
Nyambura teaches a method for the preparation of an organic-in-aqueous liquid emulsion for spray drying so as to form the spray dried particles as defined herein, said method comprising (a) providing (i) an aqueous liquid composition comprising an alginate oligomer as defined herein and an aqueous liquid composition comprising an anti-adherent compound as defined herein or (ii) an aqueous liquid composition comprising an alginate oligomer as defined herein and an anti-adherent compound as defined herein, (b) providing an organic liquid composition comprising a phospholipid as defined herein, (c) combining a volume of the organic liquid composition with a volume of the aqueous liquid compositions of (i) or the aqueous liquid composition of (ii), wherein the volume of the organic liquid composition is smaller than the total volume of the aqueous liquid composition with which it is combined, and (d) homogenising the combination so formed at any time during step (c) or on upon completion of step (c) to form the organic-in-aqueous liquid emulsion for spray drying so as to form the spray dried particles as defined herein. See paragraphs 0126-0132. The aqueous liquid composition comprising said alginate oligomer and/or said anti-adherent compound may be formed upon the dissolution of the alginate oligomer and/or anti-adherent compound in any pharmaceutically acceptable aqueous liquid. Conveniently this liquid will be water, preferably substantially pure water, e.g. distilled water or filtered water, however, some additional compounds (e.g. salts, organic acids, buffers) may also be present so long as such compounds are present in amounts that will not result in spray dried particles containing more than 10% of said compounds and do not interfere with particle formation. The method of the invention may include further steps of preparing the aqueous liquid composition(s). These steps may involve dissolving the alginate oligomer and/or the anti-adherent compound in the aqueous liquid at the same time or sequentially, or adding one of those two ingredients to an aqueous liquid already containing the other. See paragraph 0143. Homogenization can be achieved by any convenient means, e.g. by mechanical means and/or ultrasonic means, for example by high shear mixing. Apparatus for performing such a homogenization (e.g. a homogenizer) is widely known and available in the art, for example a Silverson homogenizer, which may be operated at 10,000 rpm. Homogenization is preferably performed for such time as a complete emulsion is formed to the naked eye. Homogenization may be performed as the two liquid phases are combined, or after all of the liquid phases have been combined. In other embodiments homogenization may begin once a part of each phase has been combined. See paragraph 0146 and Example 1.
Nyambura does not expressly teach dissolving carrier to form a first solution and contacting with nicotine to form a second mixture in the first solution.
Piskorz teaches a method for preparing nicotine particle comprises dissolving sugar and nicotine in a solvent such as water. The sugar and nicotine can be dissolved in solvent in any order to form a solution or solutions. The solutions are then homogenized and spray dried to form a nicotine particle having particle diameter of about 5 µm. See paragraphs 0041 and 0044-0048. Spray drying condition and temperatures is found in paragraphs 0064-0065.
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to optimize the teaching of Nyambura in view of the method in the Piskorz reference with the expectation to obtain a nicotine-containing powder having uniform particle size useful in pharmaceutical art. This is because Piskorz teaches dissolving sugar and nicotine to form two different solutions or in any order is known in the art.
Correspondence
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/SUSAN T TRAN/Primary Examiner, Art Unit 1615
