CTNF 18/717,936 CTNF 76060 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Applicant's election with traverse of Group I (Claims 1-15) in the reply filed on May 11, 2026 is acknowledged. Applicant’s argument for the traversal of the restriction requirement was carefully considered but was not found to be persuasive because even if one were to say that the inventions of Groups I-III commonly require the technical feature of an oral care composition comprising an orally acceptable vehicle, hyaluronic acid and one or more benefit agents, the Examiner already established below that such shared technical feature is taught by Ansari (WO’771) and thus, the shared technical feature is not a special technical feature as it does not make a contribution over the prior art. Also, applicant’s benzyl alcohol/taurate formulation system cannot be a special technical feature for the purpose of instant restriction requirement because the benzyl alcohol/taurate formulation system is not a commonly shared feature among the Groups I-III. The requirement is still deemed proper and is therefore made FINAL. 08-05 Claims 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on May 11, 2026. Claim Objections 07-29-01 AIA Claim 10 is objected to because of the following informalities: on line 3, applicant need to delete “is” in front of “less than” . Appropriate correction is required. 07-29-01 AIA Claim 11 is objected to because of the following informalities: on line 2, applicant need to change “one or more of a zinc source” to --- one or more zinc sources ---. Appropriate correction is required. 07-29-01 AIA Claim 15 is objected to because of the following informalities: on line 2, applicant need to change “comprises” to --- further comprises ---. Appropriate correction is required. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claim 2 is 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. Applicant recite “a derivative of hyaluronic acid” in line 2. However, applicant do not define such term in present specification, thus rendering the scope of the claim indefinite since the metes and bounds for the term is unclear. 07-34-01 Claim 3 is 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. A broad limitation together with a narrow limitation that falls within the broad limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 3 recites the broad recitation “an amount effective to treat, prevent or inhibit inflammation of the oral cavity”, and the claim also recites “preferably, . . . in an amount of from about 0.05 to about 0.5 wt.% based on the total weight of the composition.” which is the narrower statement of the limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Claim 4 is 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. Applicant define what they mean b “low-molecular weight hyaluronic acid” in [0037] of present specification. However, it is unclear what applicant mean by “ at least low-molecular weight hyaluronic acid.” 07-34-01 Claims 5-13 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. 07-34-05 AIA Claim 5 recites the limitation " the thickening agent, the humectant, the solvent, the pH modifying agent, and the flavorant " in lines 2-3 . There is insufficient antecedent basis for this limitation in the claim. 07-34-01 Claims 11-13 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 11, 12 and 13 recites the limitation "the benefit agents" or “the benefit agent” in line 1 of each of these claims. There is insufficient antecedent basis for this limitation in the claim. Applicant need to change "the benefit agents" or “the benefit agent” in each of these claims to --- the one or more benefit agents ---. 07-34-01 Claim 12 is 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 12 recites the limitation "the zinc source" in line 3. There is insufficient antecedent basis for this limitation in the claim. Applicant need to change "the zinc source" to --- the one or more zinc sources ---. 07-34-01 Claim 15 is 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 15 recites the limitation "the benefit agent " in line 1. There is insufficient antecedent basis for this limitation in the claim. Applicant need to change "the benefit agent" to --- the one or more benefit agents ---. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – 07-08-aia AIA (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. 07-15 AIA Claim (s) 1-3 and 11 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Ansari et al (WO 2018/212771 A1) . Ansari teaches (abstract, [0008]-[0009]) an oral care composition comprising hemp seed oil, capryl glycol and optionally, hyaluronic acid and aloe vera for providing effective relief of dry mouth discomfort (xerostomia). In Table 1b, Ansari teaches Mouthwash Formulation E, a mouthwash composition comprising 0.05 wt.% hyaluronic acid (which teaches instant range of claim 3 for the amount of the hyaluronic acid ), 71.0124 wt.% demineralized water ( instant vehicle of claim 1 that is a solvent ), 7.5 wt.% glycerin ( instant vehicle of claim 5 that is a humectant ), 0.03 wt.% citric acid ( instant vehicle of claim 5 that is a pH modifying agent ), 1.4 wt.% peppermint type LC flavor ( instant vehicle of claim 5 that is a flavorant ) and 1.0 wt.% hemp seed oil ( instant benefit agent of claims 1 and 11 ). Thus, Ansari teaches instant claims 1-3 and 11 . Claim Rejections - 35 USC § 103 07-20-02-aia AIA 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. 07-20-aia AIA 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. 07-23-aia AIA 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. 07-21-aia AIA Claim (s) 5-10 are rejected under 35 U.S.C. 103 as being unpatentable over Ansari et al (WO 2018/212771 A1) . With respect to instant claims 5, 6 and 8, as discussed above, Ansari’s Mouthwash E formulation discussed above contains instant humectant, solvent, pH modifying agent and flavorant . As to the thickening agent , Ansari further teaches ([0063]-[0064]) that its oral care formulations can also include additional polymers, such as 1:1 copolymer of acrylic acid with methyl acrylate, so as to adjust the viscosity of the formulation or enhance the solubility of other ingredients. It would be obvious to one skilled in the art to further include the 1:1 copolymer of acrylic acid with methyl acrylate ( instant acrylate copolymer of claim 6 ) in Ansari’s Mouthwash E formulation with a reasonable expectation of adjusting the viscosity of the formulation or enhancing the solubility of other ingredients in the formulation. Thus, Ansari renders obvious instant claims 5, 6 and 8 (the glycerin in Ansari’s formulation discussed above teaches instant humectant of claim 8). With respect to instant claim 7 , Ansari teaches ([0068]) that thickening agents can be used in its formulation in the amount of 0.5 wt.% - 5 wt.% based on the total weight of the formulation. Thus, Ansari renders obvious instant claim 7 . With respect to instant claim 9 , Ansari’s Mouthwash E formulation does not contains instant amount for the humectants (glycerin). However, Ansari teaches ([0071]) that its humectants may be present in the amount of 10-40 wt.% in its formulation. Such range overlaps with instant range of claim 9 (about 25 to about 55 wt.%), thus rendering instant range prima facie obvious. In the case “where the [claimed] ranges overlap or lie inside ranges disclosed by the prior art,” a prima facie case of obviousness would exist which may be overcome by a showing of unexpected results, In re Wertheim , 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Thus, Ansari renders obvious instant claim 9 . With respect to instant claim 10 , Ansari’s Mouthwash E formulation has a ratio of water to glycerin of 9.5 which does not teach instant range of claim 10 (less than or equal to 1.6). However, since Ansari teaches ([0071]) that its humectant amount can range from 10 to 40 wt.%, assuming that the entire amount of humectant consists of glycerin, and the amount of water plus glycerin is constant in Mouthwash E formulation, this means that the ratio of water to glycerin can range from 1.1 (44.0124 divided by 40) to 7.4 (74.0124 divided by 10). Such range overlaps with instant range of less than or equal to 1.6, thus rendering instant range prima facie obvious. In re Wertheim, supra . Thus, Ansari renders obvious instant claim 10 . 07-21-aia AIA Claim (s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Ansari et al (WO 2018/212771 A1) in view of Toda et al (JP2019-11300 A and its English translation) . Ansari does not teach the molecular weight of its hyaluronic acid. Toda teaches ([0001], [0002] and [0019]) that in oral compositions containing both cetylpyridinium chloride and water, cetylpyridinium chloride has a tendency to precipitate out of the solution at low temperatures. Toda teaches if hyaluronic acid with a Mw range of 1,000 to 700,000 Da is used, such precipitation can be prevented. Since Ansari’s Mouthwash E formulation contains cetylpyridinium chloride and water, it would be obvious to one skilled in the art to use hyaluronic acid having a Mw range of 1,000 to 700,000 Da with a reasonable expectation of preventing the precipitation of cetylpyridinium chloride. The paragraph [0037] of present specification states that the molecular weight for the low molecular weight hyaluronic acid ranges from 400,000 to 1,000,000 Da. Toda’s Mw range overlaps with instant range, thus rendering instant range prima facie obvious. Thus, Ansari in view of Toda renders obvious instant claim 4 . 07-21-aia AIA Claim (s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Ansari et al (WO 2018/212771 A1) in view of SIMON et al (US 2021/0059914 A1) and REGE (US 2019/0110965 A1) . Ansari does not teach instant zinc phosphate hydrate. Simon teaches (abstract) an oral care composition such as mouthwash comprising zinc phosphate wherein the zinc phosphate is added as pre-formed salt. Simon teaches ([0006]) that zinc phosphate, when combined with a thickener and placed in a formulation, can dissolve sufficiently to provide enough zinc ions to the tooth enamel, thereby protecting the enamel against erosion, reducing bacterial colonization and biofilm development. Simon further teaches ([0007] and [0019]) that its zinc phosphate is added as a pre-formed salt. As evidenced by Rege ([0017]), zinc phosphate hydrate is a pre-formed salt of zinc phosphate. Since Ansari teaches (see [0013], [0036], [0037] and claim 16) that an objective of its oral care formulation is to improve oral health by reducing bacterially generated biofilm and plaque and also teaches ([0061] and [0072]) that anti-plaque and anti-calculus agents, such as phosphates, may be added to its oral care formulations, it would be obvious to one skilled in the art to add zinc phosphate hydrate to Ansari’s Mouthwash E formulation with a reasonable expectation of protecting the tooth enamel against erosion, reducing bacterial colonization and biofilm development. Simon further teaches ([0018]-[0019]) that the pre-formed salt of zinc (zinc phosphate hydrate) should be added in the amount of 0.05 – 0.5 wt.%. Such range falls within instant range 0.01-5 wt.% of claim 12 and thus teaches instant range. Thus, Ansari in view of Simon and Rege renders obvious instant claim 12 . 07-21-aia AIA Claim (s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Ansari et al (WO 2018/212771 A1) in view of Montgomery (US 2008/0112903 A1) . Ansari does not teach instant sodium ascorbyl phosphate. Montgomery teaches (abstract, [0022] and [0023]) an oral care composition containing a compound that can scavenge free radicals present in the oral cavity and that can provide for increased tooth surface remineralization. Montgomery teaches ([0061] and [0064]) that its compound is preferably sodium ascorbyl phosphate which can be used in mouthwash compositions in the amount that ranges from 0.01 to 10 wt.% (see Table 1 in [0065]). Since Ansari teaches ([0013], claim 16) that its oral care formulation can be used to improve oral health by promoting remineralization of the teeth and teaches that its formulation can further contain anti-oxidants (see [0047] and [0055]), it would be obvious to one skilled in the art to use sodium ascorbyl phosphate in the amount of 0.01-10 wt.% in Ansari’s Mouthwash E formulation with a reasonable expectation of scavenging free radicals present in the oral cavity and providing for increased tooth surface remineralization as taught by Montgomery. The range taught by Montgomery (0.01-10 wt.%) for the amount of sodium ascorbyl phosphate overlaps with instant range (0.01-5 wt.%) for the amount of sodium ascorbyl phosphate, thus rendering instant range prima facie obvious. In re Wertheim, supra . Thus, Ansari in view of Montgomery renders obvious instant claim 13 . 07-21-aia AIA Claim (s) 14 and 15 rejected under 35 U.S.C. 103 as being unpatentable over Ansari et al (WO 2018/212771 A1) in view of eNatural Healing “Clove Bud Oil Vs Clove Oil Uses Compared!”, an internet article published on December 17, 2012 and obtained from the website: https://naturalingredient.org/wp/wp-content/uploads/Clove-Bud-Oil-Vs-Clove-Oil-Uses.pdf) and STRAND et al (US 2020/0390677 A1) . With respect to instant claim 14, Ansari teaches ([0052]) that flavorants such as clove oil may be used in its formulations. Thus, it would be obvious to one skilled in the art to include clove oil in Ansari’s Mouthwash E formulation with a reasonable expectation of success. Ansari’s clove oil does not teach instant clove bud oil. However, as evidenced by eNatural Healing (see the 2 nd and 3 rd paragraphs), clove oil can be made of stems, leaves and buds of the plant, but clove bud oil is the safest and most preferable of the three. Oil made from the stems and leaves, unlike clove bud oil, can cause skin irritation. Thus, it would be obvious to one skilled in the art to use clove bud oil (instead of clove oil) as the flavorant in Ansari’s Mouthwash E formulation with a reasonable expectation of reducing skin irritation. As to instant benzyl alcohol , Ansari does not teach such compound. However, Ansari teaches ([0095]) that preservatives may be used in its formulations, and as evidenced by Strand et al (abstract and [0071]), it is known in the art that benzyl alcohol may be used as a preservative in oral care compositions comprising hyaluronic acid. Since Ansari’s Mouthwash E formulation is an oral care composition containing hyaluronic acid, it would be obvious to one skilled in the art to use benzyl alcohol as a preservative in Ansari’s formulation with a reasonable expectation of success. Thus, Ansari in view of eNatural Healing and Strand renders obvious instant claims 14 (a mouthwash formulation can be used as a pre-brushing treatment). With respect to claim 15 , Ansari’s Mouthwash E formulation contains cetylpyridinium chloride in the amount of 0.075 wt.%. Although such amount does not teach instant range of claim 15 (0.1 – 2 wt.%), Ansari teaches ([0058]) that antibacterial agents such as cetylpyridinium chloride may be used in the amount of 0.01 – 10 wt.% based on the total weight of the formulation. Such range overlaps with instant range, thus rendering instant range prima facie obvious. In re Wertheim, supra . Thus, Ansari in view of eNatural Healing and Strand renders obvious instant claim 15 . Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIN J. LEE whose telephone number is (571)272-1333. The examiner can normally be reached on M-F 9 am-5:30pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached on 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov . Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice . /SIN J LEE/ Primary Examiner, Art Unit 1613 June 13, 2026 Application/Control Number: 18/717,936 Page 2 Art Unit: 1613 Application/Control Number: 18/717,936 Page 3 Art Unit: 1613 Application/Control Number: 18/717,936 Page 4 Art Unit: 1613 Application/Control Number: 18/717,936 Page 5 Art Unit: 1613 Application/Control Number: 18/717,936 Page 6 Art Unit: 1613 Application/Control Number: 18/717,936 Page 7 Art Unit: 1613 Application/Control Number: 18/717,936 Page 8 Art Unit: 1613 Application/Control Number: 18/717,936 Page 9 Art Unit: 1613 Application/Control Number: 18/717,936 Page 10 Art Unit: 1613 Application/Control Number: 18/717,936 Page 11 Art Unit: 1613 Application/Control Number: 18/717,936 Page 12 Art Unit: 1613 Application/Control Number: 18/717,936 Page 13 Art Unit: 1613 Application/Control Number: 18/717,936 Page 14 Art Unit: 1613
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