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
Newly submitted claim 7 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: claim 7 is drawn to a dental polishing apparatus, which is a materially different design, mode of operation, function, or effect, from the elected polishing paste. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 7 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Rejections - 35 USC § 112—New Matter
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 13, 14 remain 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. This rejection also applies to newly added claims 24, 26-27.
Claims 13, 14, 24 and 26-27 have been amended to recite wherein the composition further comprises “lithium disilicate”. These amendments require ingredients unintended for the claimed dental polishing paste. Nowhere in the instant specification is there support for adding lithium disilicate to the dental polishing paste, as ingredients. Lithium disilicate is disclosed as part of the ceramic to be polished by the dental polishing paste (see Summary at p. 3, lines 7-14); and the felt cone is the means by which the dental polishing paste is applied to the teeth (see p. 4, line 3). Accordingly, the amendments of claims 13, and 14 constitute new matter, insofar as they are not supported by the specification as originally filed.
Applicant postulates, “the claims are not directed to the ‘addition’ of lithium disilicate to the dental polishing paste. The claims are directed to a dental polishing paste that further includes lithium disilicate” (p. 7), which are present only after polishing of a lithium disilicate dental ceramic with the claimed polishing paste (p. 8).
However, the name of the game is the claim. Claim construction makes lithium disilicate a required component of the inventive paste, which is new matter. The polishing paste of amended claims continue to require lithium disilicate, as opposed to being the result of a future use of the product on a particular substrate, as postulated by applicant. Accordingly, the claims remain rejected as new matter.
112, 2nd Paragraph--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.
Claims 22-25 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.
The term “configured” in claims 22-25 is a relative term which renders the claim indefinite. The term “configured” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The term configured suggests some type modification to the compositions. Because the term is unsupported by the original disclosure it is unclear the degree to which the composition is “configured” in the claim to satisfy the wherein clause.
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.
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) Claim(s) 17-18, 20 remain rejected under 35 U.S.C. 103 as being unpatentable over Herman (EP 2883532, pub. 2015).
Herman teaches, “A diamond, precious or semi-precious dust polishing agent for home use and professional use in the care of natural tooth enamel and dental veneers comprised of a quantity of diamond dust coated with a lubricant in conjunction with a paste for carrying the lubricant coated diamond precious or semi-precious non-toxic abrasive dust, this dust being made of particles of a size comprised between 500 nanometers and 5 nanometers” (Abstract).
Since the particles are taught to fall with in 500 and 5 nanometers, it would have been obvious for the diamond particles to have a mean particle size of 5 to 25 nm, as per claims 17, 20-24.
“The present invention is based upon the discovery that when a dentifrice component and an abrasive containing dentifrice component which abrasive is retained within the composition, are combined and applied to the surface of the teeth, an enhanced whitening effect is obtained, when the teeth are brushed, as a result of the combined presence of the carrier and abrasive ingredients” (p. 3, para. [0017]).
“Preferably, an advantageous concentration of coated diamond dust, in relation to the volume of toothpaste, is comprised between (about) 10% and (about) 20%, preferably of about 15% of the overall volume of the composition (or agent)” (p. 4, para. [0020]).
“In the practice of the present invention, the dentifrice components in which the abrasive diamond dust material is included is generally prepared using a vehicle which contains water, humectant, surfactant and thickener” (p. 4, para. [0032]; clm. 18), wherein the humectant is “glycerine” (p. 5, para. [0033]), which may be present “in the range of (about) 10% to (about) 80% by weight” (Id. para. [0034]); wherein the surfactant is “sodium lauryl sulfate” (Id. para. [0036]); wherein the thickener can be “xanthan gum” and “sodium carboxymethyl cellulose” (cellulose gum) (Id. para. [0035]). The compositions may further comprise calcium carbonate (below), tetrasodium pyrophosphate insofar as the reference teaches “tetra alkali metal and ammonium pyrophosphate and tripolyphosphate salts” (p. 7, para. [0052]), and “sodium saccharin” (below).
The prior art teaches specific embodiments below:
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(p. 5-6, Examples 1 through 3).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to provide a dental composition comprising between 60 to 90% glycerin, 7.5 to 17.5 wt% diamond inorganic nanoparticles having ament particle size of 5 to 25 nm, and an additive (e.g. water) in view of Herman et al.
The prior art is not anticipatory insofar as it does not require the claimed amount glycerin; however, it would have been obvious to provide glycerin withing the claimed range since the prior art teaches adding glycerin as humectant within the range of about 10 to 80% by weight. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05).
2) Claim(s) 8, 19, 22 remain rejected under 35 U.S.C. 103 as being unpatentable over Herman (EP 2883532, pub. 2015) as applied to claim 17 above, and further in view of Joziak et al., (EP 2996669, pub. 2017). This rejection also applies to newly added claims 24, 28.
Herman, which is taught above, differs from claims 8, 19, 22, 24, 28 insofar as it does not teach pumice, sodium monofluorophosphate, nor benzyl alcohol.
Joziak et al. teaches oral care compositions comprising pumice and calcium carbonate (Ti). The composition “provides enhanced cleaning attributes, while maintaining low abrasivity, and which can also optionally assist in the prevention or reduction of tooth sensitivity, in particular in a hypersensitivity treatment” (p. 2, para. [0012]).
The compositions of Joziak et al. further comprise “sodium monofluorophosphate” for anti-cavity benefits (p. 6, para. [0059]) as well as “benzyl alcohol” (p. 9, Table 3, Ex. 2-4).
“The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)” (see MPEP 2144.07).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to add pumice, sodium monofluorophosphate, and benzyl alcohol to the compositions of Herman based on their suitability for their intended use in oral care formulations as taught by Joziak et al. The artisan would have been further motivated to add the ingredients based in the advantage of providing enhanced cleaning attributes, while maintaining low abrasivity, and optionally assisting in the prevention or reduction of tooth sensitivity, as taught by Joziak et al.
Since the paste of Herman is generally prepared using a vehicle which contains water, humectant, surfactant and thickener (p. 4, para. [0032]), it would have been obvious for the compositions to consist of 60-90% glycerin; 7.5-17.5 diamond nanoplatelets, calcium carbonate, water, sodium lauryl sulfate, sodium monofluorophosphate, cellulose gum, tetrasodium pyrophosphate, benzyl alcohol, sodium saccharin, and xanthan gum, as per claim 22.
Since the compositions comprise diamond nanoparticles, the compositions of the prior art are cable of performing the intended use, i.e. polishing a dental ceramic formed of lithium disilicate or zirconia having a mean surface roughness.
3) Claim(s) 17-18, 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Priyadarsini et al. (Journal of Oral Biology and Craniofacial Research, 2017) in view of Herman (EP 2883532, pub. 2015).
Priyadarsini et al. is teaches, “Nanotechnology is used in the dental field as nano dentistry” (Abstract) and identifies “Zirconia” as a type of nanoparticle used in dentistry that “[r]educes bacterial adhesion to the tooth surface, provide protection against dental caries, effective polishing agent” (p. 64, Table 3). “Nanomaterials are used in tooth paste . . .” (p. 64, Conclusion).
Priyadarsini et al. does not teach a particle size for the zirconia nanoparticles, or the contents of the toothpaste.
Herman teaches, “A diamond, precious or semi-precious dust polishing agent for home use and professional use in the care of natural tooth enamel and dental veneers comprised of a quantity of diamond dust coated with a lubricant in conjunction with a paste for carrying the lubricant coated diamond precious or semi-precious non-toxic abrasive dust, this dust being made of particles of a size comprised between 500 nanometers and 5 nanometers” (Abstract).
“The present invention is based upon the discovery that when a dentifrice component and an abrasive containing dentifrice component which abrasive is retained within the composition, are combined and applied to the surface of the teeth, an enhanced whitening effect is obtained, when the teeth are brushed, as a result of the combined presence of the carrier and abrasive ingredients” (p. 3, para. [0017]).
“Preferably, an advantageous concentration of coated diamond dust, in relation to the volume of toothpaste, is comprised between (about) 10% and (about) 20%, preferably of about 15% of the overall volume of the composition (or agent)” (p. 4, para. [0020]).
“In the practice of the present invention, the dentifrice components in which the abrasive diamond dust material is included is generally prepared using a vehicle which contains water, humectant, surfactant and thickener” (p. 4, para. [0032]; clm. 18), wherein the humectant is “glycerine” (p. 5, para. [0033]), which may be present “in the range of (about) 10% to (about) 80% by weight” (Id. para. [0034]); wherein the surfactant is “sodium lauryl sulfate” (Id. para. [0036]); wherein the thickener can be “xanthan gum” and “sodium carboxymethyl cellulose” (cellulose gum) (Id. para. [0035]). The compositions may further comprise calcium carbonate (below), tetrasodium pyrophosphate insofar as the reference teaches “tetra alkali metal and ammonium pyrophosphate and tripolyphosphate salts” (p. 7, para. [0052]), and “sodium saccharin” (below).
The prior art teaches specific embodiments below:
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(p. 5-6, Examples 1 through 3).
“The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)” (see MPEP 2144.07).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to provide for the toothpaste of Priyadarsini et al. between 60 to 90% glycerin, 7.5 to 17.5 wt% zirconia inorganic nanoparticles having ament particle size of 5 to 25 nm, and an additive (e.g. water) in view of Herman et al. The artisan would have been motivated to provide the ingredients, their concentrations, and particle sizes based on the art recognized suitability for known ingredients, their concentrations and sizes of nanomaterials for toothpaste formulations, as taught by Herman. The artisan would have been motivated to provide a size for the zirconia in the nano range insofar as the zirconia of Priyadarsini et al. is described as a nanoparticle.
4) Claim(s) 8, 19, 23 remain rejected under 35 U.S.C. 103 as being unpatentable over Priyadarsini et al. (Journal of Oral Biology and Craniofacial Research, 2017) and Herman (EP 2883532, pub. 2015) as applied to claim 17 above, and further in view of Joziak et al., (EP 2996669, pub. 2017). This rejection also applies to newly added claims 25, 29.
The combination of Priyadarsini et al. and Herman, which is taught above, differs from claims 8, 19, 23, 25, 29 insofar as it does not teach pumice, sodium monofluorophosphate, nor benzyl alcohol.
Joziak et al. teaches oral care compositions comprising pumice and calcium carbonate (Ti). The composition “provides enhanced cleaning attributes, while maintaining low abrasivity, and which can also optionally assist in the prevention or reduction of tooth sensitivity, in particular in a hypersensitivity treatment” (p. 2, para. [0012]).
The compositions of Joziak et al. further comprise “sodium monofluorophosphate” for anti-cavity benefits (p. 6, para. [0059]) as well as “benzyl alcohol” (p. 9, Table 3, Ex. 2-4).
“The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)” (see MPEP 2144.07).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to add pumice, sodium monofluorophosphate, and benzyl alcohol to the compositions of Priyadarsini et al. based on their suitability for their intended use in oral care formulations as taught by Joziak et al. The artisan would have been further motivated to add the ingredients based in the advantage of providing enhanced cleaning attributes, while maintaining low abrasivity, and optionally assisting in the prevention or reduction of tooth sensitivity, as taught by Joziak et al.
Since the paste of Herman is generally prepared using a vehicle which contains water, humectant, surfactant and thickener (p. 4, para. [0032]), it would have been obvious for the compositions to consist of 60-90% glycerin; 7.5-17.5 zirconia nanoparticles, calcium carbonate, water, sodium lauryl sulfate, sodium monofluorophosphate, cellulose gum, tetrasodium pyrophosphate, benzyl alcohol, sodium saccharin, and xanthan gum.
Since the compositions comprise zirconia nanoparticles, the compositions of the prior art are cable of performing the intended use, i.e. polishing a dental ceramic formed of lithium disilicate or zirconia having a mean surface roughness
Response to Arguments
Applicant argues, “there is no motivation to select, from the very broad range disclosed in Herman, only particles having a particle size in the very narrow range of 11 to 25 nm recited in the present claims” (p. 8). Applicant further argues that the polishing results shown at Table 3 of the specification provide evidence of unexpected results (p. 9).
Initially, it should be noted that the instant specification does not indicate that polishing results are unexpected.
Where the prior art does not disclose the exact claimed values, even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003).
Generally, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05).
In this case, the particles size of the claimed particles fall within the prior art range for the particle size.
Further, the particle size of the prior art abrasive is a result-effective variable insofar as Herman et al. teaches, “The dust polishing agent permits the user to maintain the polish and luster of natural tooth enamel or dental veneer at home without adversely abrading or damaging the surface thereof” (p. 4, para. [0019]).
Accordingly, applicant’s data at Table 3 is not unexpected insofar as the artisan would have been expected or motivated to modify the particle size to maintain polish and luster of veneers, i.e. dental ceramics, in view of Herman et al.
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.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER E WEBB whose telephone number is (571)270-3287 and fax number is (571) 270-4287. The examiner can normally be reached from Mon-Fri 7-3:30.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Walter E. Webb
/WALTER E WEBB/Primary Examiner, Art Unit 1612
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