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 final rejection. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/03/2026 has been entered.
Status of the Claims
Claims 1-4 and 10-16 are withdrawn. Claims 7, 9 and 19 are cancelled. Claims 5 and 17 have been amended. Claims 5-6, 8, 17-18, and 20-31 are presented for examination on the merits for patentability.
Rejection(s) not reiterated from the previous Office Action are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set of rejections presently being applied to the instant application.
Claim Objections
Claim 17 is objected to because of the following informalities: the claim recites “between 0, 1 and 20% by weight” in the second bullet point. The comma still needs to be changed to a period and the space needs to be removed to indicate 0.1, i.e. “between 0.1 and 20% by weight”. Appropriate correction is required.
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 17-18, 20, and 27-31 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.
Claims 17, and 27-31 are rejected for indefiniteness because the claims are drawn to a “dry, pre-mixed sugar-coated composition”, with the composition comprising a sweetening agent and starch based on the total mass of solids that comes to 100% by weight. It appears that the claims are drawn to coating composition premixes, and not a “pre-mixed-coated composition” because the weight of the material being coated, i.e. the core, is not included in the weight calculation if the sugar-coated core material is a part the composition. In order to move prosecution forward, the Examiner will interpret the phrase “dry, pre-mixed sugar-coated composition” to refer to a dry, pre-mixed coating composition comprising sugar. All claims depending from Claim 17 are also rejected.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 5-6, 8, 17-18, and 20-31 are rejected under 35 U.S.C. 103 as being unpatentable over Boua et al. (CN 103189434 B, machine translated in IP.com, Of record), hereinafter Boua in view of Cherukuri et al. (GB 2115672 A), hereinafter Cherukuri.
Regarding Claims 5-6, 17, 23 and 27, Boua discloses the invention of polysaccharide powder and polyol, primarily in crystalline form, which reads on the claimed mixture (p. 23, Invention overview). The polyol/polysaccharide ratio of the powder is between 95/5 and 30/70, preferably between 90/10 and 40/60, and even more preferably between 85/15 and 50/50, which reads on the claimed amounts in the mixture. Boua teaches the preferable polysaccharide inter alia natural pregelatinized starch (p. 24, bottom section; p. 25, 3rd paragraph; p. 53, Claim 5). Boua relates that pregelatinized starch is one of the most attractive biopolymers as an excipient for controlled release matrices because it can be produced on a large scale with high purity and low cost; is biocompatible, biodegradable, non-toxic and is useful as a binder etc. (p. 20, last paragraph). Boua does not require gum arabic.
Boua recognizes the utility of its composition in the food, pharmaceutics field etc. but does not teach a chewing gum product comprising a center homogeneously coated with a hard crystalline coating comprising the above mixture (p. 31, 1st paragraph). The invention of Boua is particularly for preparing solid forms of active ingredients with controlled release.
Cherukuri discloses applying a sugarless coating to chewing gum, pills, and tablets comprising applying to center portion a coating syrup comprising a sweet hygroscopic material, a binder, an anti-sticking compound, and a dispersing agent, and then applying a coating dusting mix (p. 1; p. 7, Claim 1). The steps of applying the coating syrup and dusting mix are repeated according to desired thickness, and provides good sweetness and flavor release properties (p. 6, lines 24-26).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine the teachings of Boua and Cherukuri and use the mixture of pregelatinized starch and sweetener of Boua in a chewing gum coating composition because pregelatinized starch has many advantageous properties. Furthermore, Boua has taught that its mixture is useful in controlling release of actives, which would be desirable in chewing gum compositions that contains actives or flavors.
Regarding Claims 8 and 18, Boua teaches natural pregelatinized starch, which the Examiner interprets to be the same as native pregelatinized starch (p. 24).
Regarding Claims 20 and 31, Boua teaches its powder have a particle size of between 50 µm and 500 µm, preferably between 80 µm and 300 µm, and even more preferably between 100 µm and 250 µm.
Regarding Claim 21, Cherukuri teaches the coating comprises about 35% of the coated chewing gum tablet, which is within the claimed range (p. 4, lines 1-4).
Regarding Claims 22, 25-26, and 29-30 Cherukuri teaches sugarless chewing gum and teaches the sweetener in the coating syrup may comprise sugar alcohols such as sorbitol, xylitol, and/or mannitol (p. 3, lines 7-10; p. 4, lines 59-60). The composition of Boua also teaches use of maltitol, sorbitol, and isomaltitol, which are known sugar substitutes is sugar-free products (Boua p. 21, 8th paragraph; p. 25, 4th paragraph; and Cherukuri, p. 1). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to make a sugarless chewing gum for various reasons, including for dietary reasons. Therefore, the composition of Boua would still be useful as coating composition in a sugarless chewing gum.
Regarding Claims 24 and 28, Boua teaches pregelatinized waxy corn starch (p. 33).
Response to Remarks:
Applicant traversed the 103 rejections over McKown; over McKown in view of De Meuter; and McKown in view of Scheick.
Applicant’s arguments have been considered but are moot because the new search based on the amendment resulted in the use of Boua as primary art, which is a closest prior art, in the rejection supra. McKown, De Meuter and Scheick are no longer relied upon for any teaching or matter specifically challenged in the arguments.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANICE Y SILVERMAN whose telephone number is (571)272-2038. The examiner can normally be reached M-F, 10-6 EST.
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/JANICE Y SILVERMAN/Examiner, Art Unit 1792
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