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 Amendment
Applicant’s response of 7/21/2026 has been received and entered into the application file. Claims 1-20 are pending in this application.
Claim Rejections - 35 USC § 103 (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 nonobviousness.
Claims 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Baig et al. (US 2021/0196581 A1), Dong et al. (WO 2020/081049 A1), Chen et al. (Hydroxyapatite in Oral Care Products – A Review, materials, 2021), and Bolli et al. (Hydroxyapatite Functionalized Calcium Carbonate Composites with Ag Nanoparticles: An Integrated Characterization Study, nanomaterials, 2021)
Baig discloses oral care compositions with a fluoride ion source. Oral care compositions with a high average fluoride ion uptake (Abstract). The composition can include the fluoride ion source in an amount sufficient to give a suitable fluoride ion concentration in the composition ([0132]). The composition can comprise about 0.5% to 75% of hydroxyapatite ([0122-0123]), about 1% to about 80% of a polymer (film-forming agent) ([0080-0082]) polyacrylate ([0096]), and adhesives such as polyvinyl alcohol ([0097]). Polyvinyl alcohol can be about 0.1% to about 50% ([0103]). The oral care composition can comprise less than about 5%, less than about 1 %, less than about 0.5%, or less than about 0.01% water by weight of the total composition ([0121]). The oral composition may also be incorporated onto strips or films ([0017]).
Dong discloses oral care film forming compositions (Abstract). The composition may include a hydrophobic copolymer, a fluoride compound, a solvent, a rosin, a cellulose derivative (Abstract). Fluoride compound is present in an amount of from about 0.5 wt % to about 8.5 wt% ([0033]). Film forming agent can be present from about 1 wt % to 9 wt % ([0037]). Adhesive can be present from about 1 wt % to 5 wt % ([0043]).
Above references do not explicitly mention nano- or micro- hydroxyapatite.
Chen discloses that in dentistry and oral care products, hydroxyapatite (HA) is a stable and biocompatible calcium phosphate with low solubility used for various applications such as tooth remineralization, reduction of tooth sensitivity, oral biofilm control, and tooth whitening (Abstract). Chen teaches that nano and micro-HA are routinely used in oral care products (pg 3).
Above references do not explicitly mention functionalized hydroxyapatite.
Bolli discloses that composite materials are very promising for biomedical and pharmaceutical applications. The composites of their work is silver nanoparticles (Ag NPs) in a matrix constituted of calcium carbonate functionalized with hydroxyapatite (HA-FCC). Bolli discloses that the composite combines the unique properties of noble metal nanoparticles with the antibacterial action of silver and biocompatibility of HA-FCC, consequently they could be very promising for application in biomedical and pharmaceutical fields (pg 2).
Therefore, it would have been obvious to one of ordinary person in the art before the effective filing date of the claimed invention to have created an oral care composition comprising a fluoride ion source, hydroxyapatite, film-forming agent, and an adhesive. These components are routinely used in an oral care composition. This is taking some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Regarding claim 2, Dong discloses that the concentration of one or more fluoride compounds may be in an amount of from about 100 ppm to about 50,000 ppm ([0033]).
Regarding claim 3, Dong discloses that the film-forming agent includes acrylate copolymer ([0006]).
Regarding claims 4-6, various hydroxyapatites are discussed above.
Regarding claim 7, Dong discloses that the film-forming agent includes acrylate/octylacrylamide copolymer ([0006]).
Regarding claim 8, rosin as an adhesive is discussed above.
Regarding claims 9-10, Dong discloses that the rosin is at least partially or fully hydrogenated ([0014]). Illustrative rosins may be or include, but are not limited to, rosins from the class of rosins known in the art such as gum rosin ([0035]).
Regarding claim 11, Dong discloses that the adhesives include polyvinylpyrrolidone ([0041]).
Regarding claim 12, Dong discloses that the orally acceptable vehicle may be present in an amount of at least 60 weight % ([0051]).
Regarding claim 13, Dong discloses that the composition includes ethyl acetate (claim 5).
Claims 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over Baig et al. (US 2021/-106581 A1), Dong et al. (WO 2020/081049 A1), Chen et al. (Hydroxyapatite in Oral Care Products – A Review, materials, 2021), and Bolli et al. (Hydroxyapatite Functionalized Calcium Carbonate Composites with Ag Nanoparticles: An Integrated Characterization Study, nanomaterials, 2021) as applied to claims 1-13 above, and further in view of Georges et al. (US 2017/0165192 A1) and Berta et al. (US 2022/0370334 A1).
Georges discloses an oral care composition including ethylcellulose, a binder, a plasticizer, a fluoride compound, a solvent, and fumed silica (Abstract). Plasticizers include citric acid esters ([0025]).
Berta discloses oral care compositions including block copolymer. Low water oral compositions including block copolymer, such as poloxamer, and flavor (Abstract). Berta discloses that one strategy to mitigate reactivity amongst oral care actives can be to use compositions with low water, no added water, or to use anhydrous compositions ([0003]).
Therefore, it would have been obvious to one of ordinary person in the art before the effective filing date of the claimed invention to have combined teachings of above with the plasticizer taught by Georges with low water content taught by Berta to create an oral care composition. This is taking some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Regarding claim 15, Georges discloses that citric acid esters include acetyl tributyl citrate ([0025]).
Regarding claim 16, Dong discloses the wt % of film-forming agent and an adhesive agent. One of ordinary skill in the art would routinely experiment with different weight ratios of components within a composition.
Regarding claim 17, water content is taught above.
Regarding claim 18, Dong discloses that the composition forms a film on the surfaces of the teeth ([0057]). One of ordinary skill in the art would immediately envisage that an oral care composition comprising a film-forming agent would be adapted to form a film ([0057]). One of ordinary skill in the art would routinely experiment with different timeframes to form a film.
Regarding claim 19, Baig discloses that the composition comprises sodium fluoride and amine fluoride or combinations thereof (claim 14). Furthermore, fluoride, hydroxyapatite, film-forming agent, adhesive, low water content are all taught by Baig as discussed above. Furthermore, one of ordinary skill in the art would routinely experiment with these routine ingredients within an oral care composition. One of ordinary skill in the art would freely include or exclude routinely used ingredients as they see fit.
Regarding claim 20, polyvinylpyrrolidone within the oral care composition is discussed above.
Response to Arguments
Applicants’ arguments filed 7/21/2026 have been fully considered and a new reference Baig et al. is incorporated to teach the newly added limitations in claims. Applicant argues unexpected results of increasing soluble fluoride by at least 77% and increase bound fluoride by at least 18% as shown in Table 10 of instant specification. However, the compositions tested are not commensurate in scope with claim 1. The examiner cannot determine if these unexpected characteristics apply only to the tested components or apply also to other routinely used adhesives or film-forming agents.
Claims 1-20 remain rejected.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN SEUNGJAI KWON whose telephone number is (571)272-7737. The examiner can normally be reached Mon - Fri 8:00 - 5:00.
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/JOHN SEUNGJAI KWON/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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