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 .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 4-8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 4 and 5 recite that the first and second treatment agents are “configured to be mixed…to provide a transparent tooth surface treatment”. The only mention of transparency in the disclosure is in regard to the appearance of the particles when mixed with a first treatment, not the appearance of the resulting composite composition (see specification paragraph 15). This transparency is discussed concerning hydroxyapatite particles not agglomerating with one another. Likely due to their size being less than the wavelength of visible light, the particles would appear more transparent if not agglomerated. This is not a commentary on the transparency of a composite composition comprising an organic acid and the particles, given that there is no discussion of the transparency of the first treatment agent. An opaque first treatment agent would be able to host transparent hydroxyapatite particles and still yield an opaque composite composition. As a result the artisan of ordinary skill would not have deemed the applicant to be in possession of the invention as currently recited at the time of filing.
This is a new matter rejection.
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.
Claims 4-8 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 4 recites that the first and second treatment agents are “configured to be mixed…to provide a transparent tooth surface treatment”. The structure of the treatment compositions that correspond to the scope is unclear as is what other actions are necessary to be taken upon the compositions in order to be “configured” to provide a transparent treatment composition. The only recited components are citric acid in a liquid and hydroxyapatite particles. In addition, the only mention of transparency in the disclosure is in regard to the appearance of the particles when mixed with a first treatment, not the appearance to the resulting composite composition. Thus the structure by the “configured to” recitation concerning transparency and the resulting scope of the claimed two part kit is unclear. Also, there are no clear structural limitations placed upon the composition via the recitation “configured to be mixed at a ratio of 0.02 g to 0.2 g of the second treatment agent per ml of the first treatment agent” because any first and second treatment agents could be mixed in this ratio. When related to the transparency of the composition, the structure (e.g., composition components and proportions) implied by the mixing ratio is not evident. Therefore the scope of compositions required by the recitation is unclear.
Claim 5 recites “the first treatment is adapted for application to a tooth surface as a cleaning agent”. The scope of structures that correspond to a treatment agent being “adapted” for the recited purpose is not clear. In one interpretation, the recitation appears to require nothing more than the structure that is already recited for the first treatment agent. In another interpretation the recitation could imply added ingredients, physical properties (e.g., viscosity), or application components. As a result, the scope of the claim is unclear.
For the sake of compact prosecution and the application of prior art, kit components that meet the recited structural limitations of the first treatment agent and second treatment agent will be deemed sufficient to meet the “configured to” and “adapted to” limitations, Clarification is still required.
Claims that are rejected but are not elaborated upon are also indefinite because they depend from an indefinite claim and do not add clarity.
Claim Rejections - 35 USC § 102/103
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.
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.
Claims 4-5 and 7-8 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Yuan et al. (International Journal of Nanomedicine 2019:14 5243–5256) as evidenced by the Citric Acid Safety Data Sheet (2026).
Yuan et al. disclose a treatment system that is used to treat teeth (see abstract and page 5244 second column third-fourth full paragraphs). They detail a 10 wt% (0.5 M) citric acid solution (as calculated by the examiner) whose existence implies its presence in some sort of container or packaging (see page 5244 second column). 10 wt% citric acid solution has a pH of 1.7 (see the Citric Acid Safety Data Sheet page 6). Deionized water is employed as a diluent (see page 5244 second column last partial paragraph). They also teach 80 nm hydroxyapatite particles in a dentifrice at 3 wt% that is subsequently used to treat the tooth (see page 5245 first column first-second full paragraphs). The existence of the dentifrice, once again, implies its presence in some sort of container or packaging. Alternatively, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the citric acid as an aqueous solution and hydroxyapatite containing dentifrice in separate containers, given that water is disclosed as a treatment solution diluent, the citric acid and dentifrice contain components that can flow (e.g., liquid and nanoparticles) and the citric acid and dentifrice are used separately at different times during the treatment process of Yuan et al. Instant claim 8 recites that the hydroxyapatite particles are manufactured from a biologically derived raw material. This recitation is a product-by-process. “’[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.’ In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)….The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979)” (see MPEP 2113). Therefore when no structure is implied, the product-by-process recitation does not add any limitations that affect patentability. Here it is not evident that the recited process implies any structure, thus the hydroxyapatite particles of Yuan et al. fulfill the limitations of the hydroxyapatite recitation of instant claim 8. Therefore claim 4-5 and 7-8 are anticipated by or, alternatively, are obvious over Yuan et al. as evidenced by the Citric Acid Safety Data Sheet).
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 4-5 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Allred et al. (previously cited) in view of Belikov et al. (previously cited) and Yoshiyama et al. (previously cited).
Allred et al. teach a tooth remineralization system composed of multiple parts (see abstract and claims 30 and 37). The system includes a priming composition that removes organic material from the enamel surface of the tooth and a remineralizing composition of calcium phosphate nanoparticles (see page 2 line 26-page 2 line 3 and claim 30). The two components may be provided in separate packaging such as syringes (see page 6 lines 1-4; instant claims 4-5). The priming composition (first treatment agent) is envisioned as an acidic preparation with a pH of below about 3 or below about 2 that is provided in the form of liquid or viscous gel (gel-like liquid) (see page 3 lines 25-28, page 6 lines 15-16, and claim 3; instant claims 4-5 and 7). They teach the calcium phosphate nanoparticles (second treatment agent) to be sized most preferably at about 100 nm or less (see page 3 lines 29-32; instant claims 5 and 8). Allred et al. go on to compare a composition that combines their priming composition and remineralizing composition to a composition with nano-hydroxyapatite devoid of a priming composition, in regard to how they achieve tooth remineralization and find the presence of the priming agent to yield a superior result (see page 8 line 28-page 12 line 10). They go on to teach kits of their exemplified preparations of priming composition with a remineralizing composition or the comparative composition paired with a priming composition as a kit to provide an envisioned product (see page 12 lines 12-16). A particular acid for the priming agent and an instantly claimed size for the nano-hydroxyapatite are not exemplified .
Belikov et al. teach an aqueous acid solution as part of a tooth rejuvenating system that regrows hard tissue (remineralize) (see abstract, claim 1, and paragraphs 114-116). The acids are envisioned as a variety of edible organic acids that include citric acid and adipic acid (dicarboxylic acid) (see paragraph 116). The acid acts to remove various material from the surface of the tooth including organic material and bacteria (see paragraphs 117-118). The acid has a pH of 0.5 to 5 (see paragraph 116). Further, they teach that the concentration of the citric acid to be within a range of 3 to 50 wt% and preferred at 10 wt% (see paragraph 272). A 10 wt% citric acid solution corresponds to 0.5 M (as calculated by the examiner).
Yoshiyama et al. also teach a composition for regenerating tooth structure (remineralization) (see paragraphs 1 and 12). The product is a system that provides calcium phosphate particles sized at 5 to 200 nm, where hydroxyapatite is an envisioned and preferred variety of calcium phosphate (see paragraphs 14, 17, and 72).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the kit of Allred et al. as separately contained/packaged parts with an acidic priming composition as a liquid in one and the remineralizing composition in another because these choices are suggested. The selection of citric acid at its preferred concentration as an edible organic acid of Belikov et al. for the acid of the priming composition would have been obvious as the simple substitution of one known element for another in order to yield a predictable outcome. Additionally, the selection of 100 nm or less sized hydroxyapatite as the calcium phosphate nanoparticles would have been obvious because 1) Allred et al. teach the utility of nanosized hydroxyapatite and this size for calcium phosphate nanoparticles and 2) Yoshiyama et al. also teach them as a preferred choice for mineralization with calcium phosphate particles of this size. The pH of the liquid and size range of the nanoparticles instantly claimed are obvious due to the overlap in range taught for these parameters via Allred et al. “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed.Cir. 1990)” (see MPEP 2144.05). Instant claim 8 recites that the hydroxyapatite particles are manufactured from a biologically derived raw material. This recitation is a product-by-process. “’[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.’ In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)….The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979)” (see MPEP 2113). Therefore when no structure is implied, the product-by-process recitation does not add any limitations that affect patentability. Here it is not evident that the recited process implies any structure, thus the hydroxyapatite particles of Belikov et al. fulfill the limitations of the hydroxyapatite recitation of instant claim 8. Therefore claims 4-5 and 7-8 are obvious over Allred et al. in view of Belikov et al. and Yoshiyama et al.
Claims 4-8 are rejected under 35 U.S.C. 103 as being unpatentable over Allred et al. in view of Belikov et al. and Yoshiyama et al. as applied to claims 4-5 and 7-8 above, and further in view of Phillips (previously cited).
Allred et al. in view of Belikov et al. and Yoshiyama et al. render obvious the limitations of instant claims 4-5 and 7-8, where the product is a multi-part part remineralization kit that includes a liquid acidic priming component. A liquid fluoride treatment is not explicitly recited as an additional part of the kit.
Phillips teaches a tooth remineralization kit (see abstract). The kit is composed of a first solution that is an acidic aqueous solution to kill bacteria in the mouth and a second aqueous solution for remineralization that comprises fluoride ions (see paragraphs 10 and 12). The fluoride ions facilitate the formation of fluoroapatite in the tooth crystal which is less soluble than the hydroxyapatite that typically occupies the enamel of the tooth and yields a stronger structure (see paragraphs 10-11). Phillips teaches fluoride ions from stannous fluoride or sodium fluoride in the second solution (see claims 1, 9, and 11; instant claim 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the remineralization solution of Phillips to the kit of Allred et al. in view of Belikov et al. and Yoshiyama et al. in a third container as an additional remineralization component to produce stronger enamel. The modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. Therefore claims 1-8 are obvious over Allred et al. in view of Belikov et al., Yoshiyama et al., and Phillips.
Response to Arguments
Applicant's arguments filed June 11, 2026 have been fully considered. In light of the amendment to the claims, the objection and rejection under 35 UC 112 are hereby withdrawn as is the rejection under 35 USC 103 over Belikov et al. as a single relied upon reference. New and modified grounds of rejection are detailed to address the new claim limitations. The applicant’s arguments concerning the previously cited prior art are not persuasive.
Regarding the rejection under 35 USC 103 over Allred et al. in view of Belikov et al. and Yoshiyama et al.:
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The applicant argues that the combination of Allred et al., Belikov et al., and Yoshiyama et al. do not provide any particular organic acid, organic acid concentration, or any particular pH value. To the contrary, Belikov et al. specifically teach 10 wt% citric acid as a particular organic acid for priming/pre-hydroxyapatite treatment for hydroxyapatite based tooth treatment systems. The citric acid inherently contributes a low acidic pH and the pH range of Allred et al., at its narrowest, details a very narrow pH that overlaps with that instantly claimed range. There is no evidence of unexpectedly superior results due to the pH of the composition. Thus the overlap in pH range is sufficient to render the instantly claimed composition obvious
The applicant additionally argues about “loading ratio” limitations. The claims are drawn to two separately packaged compositions in a kit. An intention to combine these compositions at particular ratios does not mean that the composite compositions resulting from their combination at these ratios is also claimed. Thus the prior art is not required to provide the two separately packaged compositions at any particular ratio in order to meet the instant claim limitations.
Further, the applicant discusses the transparency of the combination of the two separately packaged compositions in the claimed kit and cite table 1 of the specification for support. This table appears to speak to the transparency of the hydroxyapatite when added to an embodiment of the instant first treatment agent. There is no clear requirement that the first treatment be transparent in the disclosure or the claims. Instead the transparency of the hydroxyapatite particles is detailed in the specification due to the agglomeration or lack thereof amongst the particles. The applicant appears to argue that the choice of acid impacts the ability of the first treatment agent to disperse the hydroxyapatite particles. While a difference is seen when an inorganic acid is employed in the first treatment agent embodiment instead of an organic acid, the difference is not placed in context in regard to whether this difference is expected or unexpected when the understanding of hydroxyapatite dispersion in inorganic acid versus organic acid is considered.
The applicant also comments on a difference in the uniformity of tooth surface formation after a treatment regimen employed an embodiment of the claimed kit with organic acid versus inorganic acid in the first treatment agent. Again, there is no indication as to whether this outcome is expected or unexpected, relative to the understanding of the hydroxyapatite dispersion state and surface coating uniformity it produces on teeth.
The applicant argues that the “transparent” limitation provides structural distinction of the claimed composition over the prior art. To the contrary, there is no evidence that the prior art composition is not transparent, if combined in the intended manner. Silence in regard to this attribute is not equal to its absence. In addition, the recitation of “transparent’ in the claims does not limit the structure of the claimed kit in a clearly discernible manner.
Additionally, the applicant argues that the prior art did not discuss the desire for non-aggregated hydroxyapatite when their kit component are combined. There is no requirement that the prior art combine the kit components because the claimed product explicitly packages the two claimed treatment agents separately. The applicant’s intension to use these separately packaged compositions in combination or in series does not impact the claimed structure of the two treatment agent compositions. According to MPEP 2144 IV, “[t]he reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006).”
Regarding the rejection under 35 USC 103 over Allred et al. in view of Belikov et al., Yoshiyama et al., and Phillips:
The applicant repeats their arguments against the rejection over Allred et al. in view of Belikov et al. and Yoshiyama et al. These remarks were addressed above and the response is similarly reiterated.
Conclusion
No claim is allowed.
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 CARALYNNE E HELM whose telephone number is (571)270-3506. The examiner can normally be reached Mon-Fri 9-5.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Wax can be reached at (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CARALYNNE E HELM/Examiner, Art Unit 1615
/MELISSA S MERCIER/Primary Examiner, Art Unit 1615
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