DETAILED ACTION
Previous Rejections
Applicant’s arguments, filed June 18, 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Information Disclosure Statement
In the remarks dated June 18, 2026, Applicant asserts that no information disclosure statement size fee under 1.17(v) is required for the IDS submitted April 15, 2025. Therefore, the information disclosure statement dated April 15, 2025 has been considered by the Examiner.
Claim Status
Claims 18 and 19 are cancelled.
Claims 21 and 22 are newly added.
Claims 1 – 17 and 20 – 22 are examined here-in.
Claim Rejections - 35 USC § 103 (New, Necessitated by Amendment)
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 non-obviousness.
Claims 1 – 17, 20, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Constantine (US 2022/0241180 A1) in view of Mikkelsen (US 2010/0034871 A1, of record).
Constantine teaches an oral care product for cleaning the teeth that “can substantially sustain its physical shape” while “being sufficiently soft” (abstract, paragraphs 0002, 0008). Constantine teaches the composition is preferably in the form of a semi-solid such as a jelly that can sustain its physical shape when unsupported but is sufficiently soft that it may be applied directly to the teeth of the user (paragraph 0023).
Constantine teaches a composition comprising a sugar alcohol, water, and a gelling agent (abstract, paragraph 0009).
Constantine teaches the sugar alcohol is selected from sorbitol and xylitol, or a combination thereof in an amount of 5 to 70% by weight of the composition (paragraphs 0043 – 0047). Constantine teaches the combination of a sugar alcohol with water and a gelling agent results in a composition having a semi-solid, jelly-like texture (paragraph 0054).
Constantine teaches the composition includes water in an amount of 20 to 60% by weight of the composition (paragraph 0057).
Constantine teaches gelling agents including starch, agar, carrageenan, pectin, gellan gum, alginate, methyl cellulose, and hydroxypropyl methylcellulose (paragraphs 0063 – 0064). Constantine teaches gelling agent in an amount of 0.1 to 5% by weight of the composition (paragraph 0077).
Constantine teaches the composition may further include humectants other than sorbitol and xylitol, such as glycerin, propanediol, and propylene glycol, among others (paragraphs 0079 – 0081).
Constantine teaches the composition further comprises one or more cosmetically acceptable additives, such as surfactants (paragraphs 0135, 0141). Constantine teaches surfactants such as sodium lauryl sulfate and cocamidopropyl betaine are suitable for inclusion in the composition in an amount of 0.1 to 40% by weight of the composition (paragraphs 0141 – 0142).
Constantine does not teach the composition is a single-dose unit or that the composition includes one or more coating ingredients.
Mikkelsen teaches the missing elements of Constantine.
Mikkelsen teaches a center-filled chewing gum product that includes functional agents, wherein the chewing gum substances encloses a center filling, and the center filling includes a toothpaste (abstract).
Mikkelsen teaches the center-filled chewing gum product may be used for dental care treatment of the teeth in a manner that is comparable to that achieved with a toothbrush (paragraph 0017). Mikkelsen teaches that the dental care provided is gentle for the teeth and gingiva, and thus avoids damage that is generally experienced as a result of tooth brushing (paragraphs 0018 – 0019).
Mikkelsen teaches the center filling has an outer coating that protects the product and provides it with a consumer friendly appearance and sensation (paragraphs 0143, 0159 – 0161). Mikkelsen teaches the coating ingredient may be a wax, noting that carnauba wax is a suitable encapsulant (paragraphs 0161, 0266). Mikkelsen also notes that the coating may include anti-sticking components (paragraph 0385).
The combination of Constantine and Mikkelsen’s teachings renders claims 1 – 17, 20, and 22 prima facie obvious as combining prior art elements according to known methods to yield predictable results (MPEP 2143(i)(a)). A person of ordinary skill in the art would have been motivated to modify Constantine’s teaching for an oral care product that “can substantially sustain its physical shape” while “being sufficiently soft” (abstract, paragraphs 0002, 0008, 0023) to be a single-dose unit like Mikkelsen’s chewing gum for consumer convenience and ease of use. The combination of Constantine and Mikkelsen’s teachings would be expected to yield nothing more than predictable results (e.g., a unit-dose toothpaste composition with humectant, gumming, and surfactant ingredients) to one of ordinary skill in the art which is prima facie obvious according to MPEP 2143(i)(a).
The combination of Constantine’s teaching for an oral care product that “can substantially sustain its physical shape” while “being sufficiently soft” which comprises a sugar alcohol, water, a gelling agent, and a surfactant (abstract, paragraphs 0002, 0008 – 0009, 0023, 0135, 0141 – 0142) with Mikkelsen’s teaching for a center-filled chewing gum product (i.e. a single-dose unit) that includes an anti-sticking agent (abstract, paragraphs 0062, 0068 – 0069, 0143, 0159 – 0161, 0275, 0378, 0385, claim 23) reads on instant claim 1.
Constantine’s teaching that the composition includes a sugar alcohol selected from sorbitol and xylitol, or a combination thereof in an amount of 5 to 70% by weight of the composition (paragraphs 0043 – 0047) reads on the one or more humectant ingredients in an amount of 63 to 70% by weight of the composition as recited in instant claims 2 and 5. Claimed ranges that overlap teachings of the prior art are prima facie obvious according to MPEP 2144.05(i). A person of ordinary skill in the art would be motivated to include sorbitol or xylitol in the range taught by Constantine because Constantine teaches that the specific combination of a sugar alcohol with water and a gelling agent results in a composition having a semi-solid, jelly-like texture (paragraph 0054).
Constantine’s teaching for gelling agents including starch, agar, carrageenan, pectin, gellan gum, alginate, methyl cellulose, and hydroxypropyl methylcellulose in an amount of 0.5 to 5% by weight of the composition (paragraphs 0063 – 0064, 0077) reads on the gumming ingredients in an amount of 1.25 to 2.5% by weight of the composition, as recited in claims 3 and 6.
Constantine’s teaching for surfactants such as sodium lauryl sulfate and cocamidopropyl betaine in an amount of 0.1 to 40% by weight of the composition (paragraphs 0141 – 0142) reads on surfactants in an amount of 1.5 to 2.0% by weight of the composition, as recited in claims 4 and 7.
Mikkelsen’s teaching that the coating ingredient may be a wax and that carnauba wax is a suitable encapsulant (paragraphs 0161, 0266) reads on instant claim 8.
Mikkelsen’s teaching that the composition may include whitening agents, fresh breath agents, anti-plaque agents, anti-gingivitis agents, re-mineralization agents, or anti-calculus agents (paragraphs 0078 – 0087) reads on instant claim 9.
Mikkelsen’s teaching for hydrogen peroxide as a suitable whitening agent (paragraph 0308) reads on instant claim 10.
Mikkelsen’s teaching for anti-carie and re-mineralization agents including sodium fluorophosphate, sodium fluoride, and nano-hydroxyapatite, among others (paragraphs 0084 – 0086) reads on the one or more anticavity agents of instant claim 11.
Mikkelsen’s teaching for zinc citrate as an appropriate anti-plaque agent to reduce, remove, or inhibit plaque (paragraph 0301) reads on the one or more tartar control agents of claim 12.
Mikkelsen’s teaching for potassium salts as tooth desensitizing agents (paragraph 0290) reads on the one or more sensitivity relief agents of claim 13. Although Mikkelsen does not teach the potassium salt is potassium nitrate specifically, it is within the expertise of a person of ordinary skill in the art to select potassium nitrate as the potassium salt through routine experimentation. A person of ordinary skill in the art would have been motivated to select potassium nitrate from potassium salts because potassium nitrate is well-known and commonly used in toothpaste compositions. Routine optimization is prima facie obvious according to MPEP 2144.05(ii)(a).
Constantine and Mikkelsen each teach that the composition can be made by first combining and mixing the ingredients, extruding or casting into the desired shape, allowing the composition to cool and solidify, then coating the solid (Constantine paragraphs 0184 – 0190, Mikkelsen paragraphs 0392 - 0399, 0412 – 0414) reading on instant claim 14.
Mikkelsen’s teaching for a cooling step that occurs at a temperature below 45 °C (paragraphs 0398, 0404, 0413) overlaps on the instantly claimed range of negative 1 and positive 4 °C as recited in claim 14. Although Mikkelsen does not teach cooling for a specific length of time, Mikkelsen does teach that a person of ordinary skill in the art would have the necessary expertise to choose and optimize parameters such as time (paragraphs 0388, 0399, 0400, 0413). As such, it would be prima facie obvious for a person of ordinary skill in the art to determine an appropriate time for cooling, based on the desired properties of the composition, according to routine experimentation, thus reading on instant claim 14. Routine experimentation is prima facie obvious according to MPEP 2144.05(ii)(a).
Mikkelsen’s teaching that the center-filled product may be shaped into a pellet, a tablet, a chunk, a pill, a ball, or a sphere, and that it will have a mass between 1 and 5 grams (paragraph 0387) reads on instant claims 15 and 16.
Mikkelsen’s teaching that the final center-filled chewing gum products are packaged and labeled with instructions for use (paragraph 0405, claim 103) reads on instant claim 17.
Mikkelsen’s teaching that the coating ingredient may be a wax and that carnauba wax is a suitable encapsulant (paragraphs 0161, 0266) reads on instant claim 20.
Constantine’s teaching that the composition is preferably in the form of a semi-solid such as a jelly that can sustain its physical shape when unsupported but is sufficiently soft that it may be applied directly to the teeth of the user (paragraph 0023) reads on instant claim 22. The limitation “configured to dissolve upon agitation with a wet toothbrush” is viewed an intended use limitation. Constantine’s teaching for a semi-solid jelly oral care composition for brushing teeth appears to be capable of meeting the intended use of dissolving upon agitation with a wet toothbrush because it contains substantially the same ingredients and is targeted to the same final use as that which is instantly claimed.
Examiner’s Reply to Attorney Arguments Dated June 18, 2026
Applicant’s arguments have been considered but are moot because the new grounds of rejection specifically addresses the claims as presently amended.
Applicant’s Declaration Dated June 18, 2026
The Examiner has fully reviewed and considered the Declaration submitted June 18, 2026, setting forth rheology characterization of storage and loss modulus for the jelly-like composition claimed, arguing that these characteristics set the instant invention apart from the Mikkelsen reference (Declaration page 4). According to MPEP 716.02(e), an affidavit or declaration must compare the claimed subject matter with the closest prior art. Therefore, the evidence submitted in the declaration and applicant’s arguments relating thereto have not been found persuasive.
Potentially Allowable Subject Matter
Claim 21 appears to be free of prior art as Constantine and Mikkelsen alone or in combination do not teach or suggest citrus fiber powder as a coating ingredient for the composition. Therefore, claim 21 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Toriana N. Vigil whose telephone number is (571)270-7549. The examiner can normally be reached Monday - Friday 9:00 a.m. - 5:00 p.m. EST.
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/TORIANA N. VIGIL/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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