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 Objections
Claims 7 and 8 are objected to because of the following informalities: the claims recite “any one of claim 4”. The recitation “any one of” is inconsistent with the rest of the claim when followed by the recitation of a single claim number Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 4-6 have preambles that recite a product. However, the body of claims 4-6 recite limitations for a product then additional recite steps that use the product. For example, claim 4 recites two separately contained product components, then recites a step of mixing these two products together which yields a singe preparation. The product cannot be both separately packaged and a single preparation, as it exists at the end of the recited method step. Claims 5 and 6 also recite use steps that involve application of the product. The mixture of statutory classes makes the scope of the claims unclear, especially in the case of claim 4 where contradictory configurations of the product are recited. For the sake of compact prosecution and the application of prior art, the claims will be construed as product claims such that the process of use recitations do not impact the product. Clarification is still required.
Claims that are rejected but are not explicitly expounded upon are also indefinite because they depend from an indefinite claim and do not add clarity.
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 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Belikov et al. (US PGPub No. 2008/0280260).
Belikov et al. teach a composition for tooth rejuvenation (see abstract). The composition is detailed as an aqueous solution comprising an edible acid selected from a group that includes citric acid and adipic acid (dicarboxylic acid) in which hydroxyapatite particles that are sized at 25 nm 60 mm are also included (see claims 1-12 and paragraph 116). The pH of the solution may be 0.5 to 5 (see claim 6).
While a full example of each embodiment that follows from the teachings of Belikov et al. is not detailed, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select an envisioned edible acid for their composition with the taught hydroxyapatite particles sizes and overall pH. The resulting ranges for the particle size and pH overlap with the instant claimed ranges, thereby rendering the claimed ranges obvious. “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 3 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 3. Therefore claims 1-3 are obvious over Belikov et al.
Claims 1-5 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Allred et al. (WO 2014/151244) in view of Belikov et al. and Yoshiyama et al. (JP 2012077009 - English translation relied upon for translation).
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 is envisioned as an acidic preparation with a pH of about 3 or about 2 that is provided in the form of liquid or viscous gel (gel-like liquid) (see page 6 lines 15-16 and claim 3; instant claims 1 and 4-5). They teach the calcium phosphate nanoparticles to be sized most preferably at about 100 nm or less (see page 3 lines 29-32; instant claims 1, 3,-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 size for the nano-hydroxyapatite is not detailed.
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).
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 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 Allred et al. teach the utility of nanosized hydroxyapatite and this size for calcium phosphate nanoparticles and 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 the cited prior art (see MPEP 2144.05). Instant claims 3 and 8 recite 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 claims 3 and 8. Further claims 4 and 5 are product claims according to their preambles, yet they recite active process of use steps. These recitations do not limit the product and are not required in order to meet the limitations of the product. Therefore claims 1-5 and 7-8 are obvious over Allred et al. in view of Belikov et al. and Yoshiyama et al.
Claims 1-8 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 1-5 and 7-8 above, and further in view of Phillips (US PGPub No. 2006/0216247).
Allred et al. in view of Belikov et al. and Yoshiyama et al. render obvious the limitations of instant claims 1-5 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..
Conclusion
No claim is allowed.
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/CARALYNNE E HELM/ Examiner, Art Unit 1615