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 .
Response to Election/Restrictions
Applicant’s elections without traverse of Group I in the reply filed on September 5, 2025 and a method of enhancing the hardness of teeth on September 24, 2025 are acknowledged.
Claims 9-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on September 5, 2025 and September 24, 2025.
Note to Applicant: There appears to be a claim after claim 14 that is incomplete.
Claims
Claim Objections
Claims 1-8 are objected to because of the following informalities: the claims comprise capitalized words that aren’t required to be capitalized. Appropriate correction is required.
Claim Rejections - 35 USC § 112 - Indefiniteness
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 8 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 8 recites (Seaweed) and (White Turmeric). It is not clear if the components in the parenthesis are another name for the component each one follows or a species/example of the component each follows. Therefore the claim is indefinite.
Claim Rejections - 35 USC § 102 – Anticipation
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 –
(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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
1) Claims 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Farooq et al. (US 20170319455).
Farooq et al. disclose methods of remineralizing the teeth with toothpaste. The toothpaste may be applied onto a mouth tray and the teeth are contacted with the toothpaste present in the mouth tray wherein the toothpaste includes theobromine and at least one of a bioactive glass and hydroxyapatite (Abstract). The toothpaste may be applied in the form of a gel or hydrogel and comprises polymers. The toothpaste comprises 10 to 30% theobromine based on the weight of the bioactive glass or hydroxyapatite used in a toothpaste composition (paragraph 0008). The hydroxyapatite comprises 5 to 95% wt% based on the weight of the bioactive glass. Preferably, the apatite derivative is crystalline, and may have a nanorod shape. The apatite derivative particle may have a length ranging from 500 nm to 2 μm and a cross section 20-100 nm. This would meet the limitation of nano-hydroxyapatite or micro-hydroxyapatite.
Farooq et al. anticipate the instant claims.
2) Claim(s) 1-4 and 6-8 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Schulze Zur Wiesche et al. (US 2024/0207157, Schulze).
Schulze discloses oral care agents such as toothpaste and mouthwash comprising a methylxanthine and a calcium phosphate compound. The methylxanthine include theobromine. The calcium phosphate compound includes hydroxyapatite. The oral care agent mineralizes already existing, minor caries lesions, and/or repairs microfine defects in the tooth enamel (paragraph 0056). This would enhance the hardness of the teeth. The calcium phosphate comprises 0.1 to 20% by weight of the oral care agent. The volume-based particle size distribution of the calcium phosphate compounds is preferably 100 nm to 5500 nm, which encompasses nano- and micro-hydroxyapatite. Xylitol can minimize the number of caries bacteria and inhibit their growth. Furthermore, xylitol can stimulate the flow of saliva. The increased amount of saliva results in an increased amount of phosphate. This phosphate can react together with the calcium (ions) from the oral care agent according to the invention to form hydroxyapatite. The oral care agent according to the invention can contain xylitol in an amount of from 1 to 10% by weight in relation to the total weight of the oral care agent (paragraph 0132). A composition comprises 20% hydroxyapatite, 0.0005% theobromine, 0.0005% caffeine, 0.1% tocopheryl acetate (a form of vitamin E) and 2% xylitol (Exemplary embodiment 2).
Caffeine is used together or alternatively to theobromine. Caffeine may comprise 0.0005 to 1% (ref. claim 3). Therefore, based on the example, theobromine would also be included in this range.
Schulze anticipates the instant claims.
Claim Rejections - 35 USC § 103 – Obviousness
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.
1) Claims 3-8 are rejected under 35 U.S.C. 103 as being unpatentable over Farooq in view of Farooq et al. (US 20170319455) in view of Cho (KR 20170053073).
Farooq et al. is discussed above and discloses the toothpaste comprises 10 to 30% theobromine based on the weight of the bioactive glass or hydroxyapatite used in a toothpaste composition (paragraph 0008). The hydroxyapatite comprises 5 to 95% wt% based on the weight of the bioactive glass. The amount of hydroxyapatite and theobromine are disclosed in regards to a different component but not in the disclosed compositions.
Therefore, Farooq et al. differ from the instant claims insofar as it does not disclose the amount in the oral care composition.
Cho discloses toothpaste compositions. The composition comprises a xylitol sweetening agent and a bone strengthening agent comprising hydroxyapatite. Hydroxyapatite comprises 0.001 to 20 wt% off the composition. These amounts are used because if the content is less than 0.001% by weight, the effect of re-crystallization is deteriorated and if the content is more than 20% by weight, the properties inherent to the component may be lost. Xylitol comprises 0.001 to 20% by weight. Antioxidants are added and include ascorbic acid and tocopherol. The antioxidants are used to prevent discoloration and toxicity in the composition. The amount of the antioxidants to be used is 0.1 to 1.0% by weight based on the total weight of the dentifrice composition.
It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have used 0.0001 to 20 wt% hydroxyapatite when formulating the toothpaste of Farooq et al. to mineralize the teeth because this is an appropriate amount to obtain its desired function such as bone growth, which would also strengthen the enamel.
The amount theobromine may be based on the hydroxyapatite. Therefore, when hydroxyapatite ranges from 0.0001 to 20%, the amount of theobromine will range from 0.00001 to 6% by weight of the composition. It is well-settled, however, that even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05. Accordingly, since an overlap plainly exists here, it would have been obvious to have selected values within the overlap. Therefore the ranges of the instant claims are obvious over Farooq et al.
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have added tocopherol or ascorbic acid as antioxidant and xylitol as a sweetener in an amount from 0.001 to 20% by weight to the composition of Farooq et al. to use in a method of mineralizing teeth, which would enhance the hardness of teeth, motivated by the desire to prevent discoloration and toxicity in the composition and because xylitol is a suitable sweetening agent for oral care compositions.
2) Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Schulze Zur Wiesche et al. (US 2024/0207157, Schulze) in view of Durhan et al. (Acta Stomatol. Croat., 2021).
Schulze is discussed above and differs from the instant claims insofar as it does not disclose the specific amount of theobromine recited by the instant claims.
However, theobromine containing toothpastes can be considered effective agents in remineralizing white spot lesions and can be used in prevention of early enamel lesions.
Theobromine acts as a remineralizing agent and is used to prevent early enamel lesions, making it a result effective variable. It would have taken no more than the relative skill of one of ordinary skill in the art to have adjusted the amount of theobromine to 0.004 to 0.20% to yield the desired therapeutic effect. See MPEP 2144.05.
Claims 1-8 are rejected.
Claims 9-16 and 23 are withdrawn.
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEZAH ROBERTS whose telephone number is (571)272-1071. The examiner can normally be reached Monday-Friday 11:00-7:30.
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/LEZAH ROBERTS/Primary Examiner, Art Unit 1612