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 .
Detailed Action
This application is a national stage application of PCT/CN2021/104937, filed July 7, 2021. Claims 1-12 are pending in this application and examined on the merits herein.
Claim Rejections - 35 USC § 112
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 2 and 4-12 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.
These claims all include a limitation defining a first range, followed by a second limitation including the term “preferably” and a second, narrower range. These instances are as follows:
Claim 2 – “to -10 to 30OC, preferably to 0 to 10OC.”
Claim 4 – “a mass ratio of 1-3:1, preferably 1.5-2:1,” “5-15OC, preferably 0-5OC,” and “2-12 hours, preferably 6-10 hours.”
Claim 5 – “15-40%, preferably 25-35%,” and “5-20%, preferably 10-15%.”
Claim 6 – “The oxidation reaction is -10 to 20OC, preferably to 0 to 10OC;” and “1-12h, preferably 6-10h.”
Claim 7 – “the alkaline hydrolysis agent is one or more of ammonia, triethylamine, diethylamine and dimethylamine; preferably, the alkaline hydrolysis agent is dimethylamine,” and “the concentration of dimethylamine is 10%-45 wt%, preferably 30%-40 wt%.”
Claim 8 – “the reaction temperature of the alkaline hydrolysis reaction is set to be -10 to 30°C, preferably 0 to 10°C,” “3-12 h, preferably 6-10 h;” and “7-12, preferably 9-10.”
Claim 9 – “6-8, preferably7, “heating to 30-60°C, preferably 40-50°C,” “the acidic substance is sulfuric acid, acetic acid or hydrochloric acid, preferably hydrochloric acid;” and “10-35%, preferably 25-30%.”
Claim 10 – “0.5-4:1, preferably 1-2:1”
Claim 11 – “30-80°C, preferably 35-55°C;” “-0.050 MPa to -0.99 MPa, preferably from -0.50 MPa to -0.8 MPa;” and “1-2 g/cm³, preferably 1.1-1.5 g/cm³.”
Claim 12 – “2-24 h, preferably 6-12 h;” and “-10 to 15°C, preferably 0 to 5°C.”
Reasons for Allowance
Claims 1 and 3 are seen to be allowable. In particular, Applicant’s attention is directed to PCT international publication WO2008/084498 (Reference included with PTO-892) This publication, representing the closest prior art, describes a process for producing 4,1’,6’-trichlorogalactosucrose, (TGS) which is a synonym for sucralose, by 6-acetylating and then chlorinating sucrose. (p. 1 lines 10-21) This reference is specifically directed to a process for removing coloring impurities from this reaction mass that involves oxidizing the crude reaction mixture with ozone. (p. 2 lines 19-24) This somewhat resembles the claimed process in that it involves removing impurities using an oxidation step. However, even when this ozone treatment is performed on the 6-acetyl TGS, it is unclear whether it has the claimed effect of converting some portion of the impurities in the crude reaction mixture into sucralose-6-ester. Rather, based on the disclosure of WO2008/084498 the intent of the ozone treatment is to remove colored impurities described as “ a mixture of caramel, furfurals, etc.” There is no reason to believe that ozonolysis of these colored compounds followed by alkaline hydrolysis would convert any portion of them into sucralose-6-ester.
Similarly, US pre-grant publication 2010/0160625 (cited in PTO-892) describes a process for the production of sucralose wherein a side product of the chlorination reaction (deacetylated TGS) is reacylated to reform 6’-O-acyl TGS, which is more easily purified from the reaction mixture than its deacylated counterpart. (See p. 1 paragraphs 2-4) However, while conceptually similar to the process of claim 1, this process does not utilize an oxidation or alkaline hydrolysis step.
Conclusion
Claims 2 and 4-12 are rejected. Claims 1 and 3 are seen to be allowable.
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/ANDREA OLSON/Primary Examiner, Art Unit 1693 6/24/2026
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