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 .
Status of the Application
Claims 30-49 filed in a preliminary amendment on 4/2/2025 are pending in the application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/25/2026, 9/15/2025 and 8/30/2024 were filed before the first office action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claim 30, 44 and dependent claims 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.
Claim 30 recites a chewing gum comprising sodium hexametaphosphate wherein the sodium hexametaphosphate in the gum is in an amount of from 0.2 wt.% to less than about 2 wt.%. As “chewing gum “ is a formulated product wherein “gum” is an ingredient, it is unclear whether the weight percentages are calculated based on the chewing gum of unspecified composition or the gum ingredient. One of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Appropriate correction is required. A chewing gum composition is applied in examination.
Claim 44 recites a method for the prevention of tooth staining in a consumer, the method comprising chewing a gum of claim 30 wherein the gum provides at least 16.5 mg of sodium hexametaphosphate per serving. The actual dose of sodium hexametaphosphate is not clear. The claim does not recite how many servings should be chewed, and no upper limit for dosing is provided. One of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Appropriate correction is required.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 30-32, 34-36 and 38- 49 are rejected under 35 U.S.C. 103 as being unpatentable over Saito et al. (JP2018115212A, machine translation) in view of Santhanam et al. (WO2020113184A1 cited in an IDS).
Regarding claim 30-32, Saito discloses a chewing gum comprising sodium metaphosphate (polyphosphate) wherein the sodium metaphosphate in the gum is 0.33 wt.% to 2.0 wt.%, which overlaps or encompasses the claimed levels of SHMP in a chewing gum, and wherein the gum upon chewing removes tooth stains.
Regarding claims 34-36, Saito discloses citric acid, malic acid in the composition which are fruity acids per claim 35.
Saito does not specifically call out sodium hexametaphosphate in the broadly recited “sodium metaphosphate”.
Santhanam however discloses a confectionery composition (mints) for tooth stain removal, comprising up to 10 wt.% sodium hexametaphosphate, and 0.1-4.0 wt.% food-grade acid, encompassing the claimed ranges of acidulant. Santhanam cites prior use of sodium hexametaphosphate in chewing gum for removal of stains from teeth and preventing formation of new stains [0032][0033], and further discloses (Example 4) that addition of citric acid improves tooth stain removal [0088] detailing a mechanism whereby the sodium hexametaphosphate specifically has this effect.
As both Saito and Santhanam are directed to oral compositions for tooth stain removal, it would have been obvious to one of ordinary skill in the art to specifically use sodium hexametaphosphate in a chewing gum composition for tooth stain removal in Saito with a reasonable expectation of success.
Regarding the claimed alternative ranges for sodium hexametaphosphate and acids in the composition, applicant has not shown unexpected results with specific combinations.
It has been previously held that “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claims 38-42 Saito discloses preparing the chewing gum in various shapes and forms (last paragraph in the machine translation) including center-filled and coated. Absent a showing of unexpected results with a particular shape or form, a patentable distinction is not discerned. Regarding claim 43, the dimensions claimed fall within the conventional for chewing gum products and do not provide a patentable distinction, absent a claim to unexpected results with a specific composition, shape and size.
Regarding claims 44-49, Saito discloses an exemplary dosing schedule of 2 pieces of the gum of that invention for 7 times a day for 7 days. One of ordinary skill in the art would have experimentally determined the consumption regimen of the gum in modified Saito to effect tooth stain removal, with a reasonable expectation of success.
Claims 33 and 37 are rejected under 35 USC 103 as being unpatentable over Saito in view of Santhanam as applied to claim 30 above and further in view of Gebreselassie et al. (US 9198448 B2, cited in an IDS).
Regarding claims 33 and 37, Saito in view of Santhanam does not specifically disclose encapsulated polyphosphates and acids as claimed. However, Gebreselassie discloses the successful application of encapsulated polyphosphates and acids in oral compositions (see abstract). Gebreselassie discloses that specifically, polyphosphates, such sodium hexametaphosphate (SHMP), react with stability-limiting acids (e.g., citric acid)., reducing the shelf-life of the oral composition, and results in the production of undesirable by-products. One of ordinary skill in the art would have been motivated to encapsulate the sodium hexametaphosphate and acids in a chewing gum composition with a reasonable expectation of successfully producing a stable chewing gum product comprising SHMP and fruity acids, in modified Saito.
Claims 30-49 are therefore prima facie obvious in view of the art.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Subbalakshmi Prakash whose telephone number is (571)270-3685. The examiner can normally be reached Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Emily Le can be reached at (571) 272-0903. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUBBALAKSHMI PRAKASH/Primary Examiner, Art Unit 1793
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