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 .
DETAILED ACTION
The Applicant’s reply filed on 9/17/26 is acknowledged. Claims 1-19 and 21 are pending. Claims 9 and 20 (now canceled) have been withdrawn. Claims 1, 17, and 18 have been amended. Claim 21 is new.
Claims 1-8, 10-19, and 21 are under consideration to the extent that the composition comprises the elected species of nitric acid as the species of mineral acid and FD&C green 3 as the species of caries indication dye.
Objections Withdrawn
The objections of the Abstract, Drawings, and Specification are withdrawn in view of the amendments.
Rejections Withdrawn
The rejection of Claims 17 and 18 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite are withdrawn in view of the amended claims.
Rejections Maintained and New Grounds of Rejections
Claim Objections
Claims 9 and 18 are objected to because of the following informalities:
Claim 9 includes an incorrect status identifier and should read “Withdrawn”.
Claim 18 has been amended to include “indication” but has not struck through “indicator”.
Appropriate correction is required.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-8, 10, 12-14, and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Hagne (WO 98/46194) in view of Vista Apex (“Clean & Boost® Dentin and Enamel Cleanser”; 2021) as evidenced by Intermed 2019 (“Clean & Boost SDS”; 2019) and InterMed 2020 (“510(k) Summary for Vista Dyes”; 2020).
Hagne teaches etching and detection composition for conditioning dental cavities in a single step, comprising a component a) which is an etching compound and a component b) which is a caries detector (e.g. abstract). Hagne teaches that use of these different solutions (i.e. separate steps of etching and caries indicating) is time consuming and sometimes impractical, and their invention comprises a solution to the aforesaid problems and it is possible to etch and detect in a single step, thus eliminating the aforesaid problems while simultaneously gaining time and cutting costs (e.g. pages 2-3). Hagne exemplify a composition comprising phosphoric acid (i.e. at least one mineral acid), at least one caries indication dye, and water (e.g. page 4).
Hagne does not teach the elected species of nitric acid as the species of mineral acid or FD&C green 3 as the species of indication dye, or the inclusion of at least one alcohol. This is made up for by the teachings of Vista Apex and Intermed 2020.
Vista Apex teaches that “Clean & Boost® Dentin and Enamel Cleanser” is a water based cleanser designed to remove contaminant from the surface of a tooth prior to bonding, while being kinder to tissues than phosphoric acid etchants (e.g. page 1). Vista Apex teaches that the composition comprises nitric acid, isopropyl alcohol, water, and HEMA (e.g. pages 1-2).
InterMed 2020 teaches that Vista Dyes are colored agents that when applied to the suspected carious areas of the tooth stains the carious dentin (e.g. page 1). InterMed 2020 teaches that Vista Dyes comprise propylene glycol and 1% FD&C green (e.g. page 2).
Regarding Claims 1-4, 8, 10, 12 and 13, it would have been obvious to one of ordinary skill in the art at the time of filing to combine the etchant of Vista Apex and the stain of Intermed 2020 as suggested by Hagne. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results. One of ordinary skill in the art would have predicted success as all of the compositions are useful as dental compositions and one of ordinary skill would have been motivated in order to provide the benefits of a single step composition as taught by Hagne, with an etchant that is kinder to tissues, as taught by Vista Apex, and the dye of Intermed 2020. In addition, it would have been obvious to one of ordinary skill in the art at the time of filing to combine the compositions of Hagne, Vista Apex, and InterMed 2020 to form a new composition. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
“When a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Regarding the limitation, “wherein the composition simultaneously indicates carious dentin, etches dentin, and cleanses the dentin prior to the application of a bonding agent”, this is directed to an intended use of the product. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The claimed compositions are met as described supra. Nevertheless, Hagne discloses etching and detection composition for conditioning dental cavities in a single step (e.g. abstract; Claim 1).
Regarding Claim 5, Hagne further teaches the inclusion of a viscosity-enhancing agent (i.e. a thickening agent) (e.g. page 4, line 11-15).
Regarding Claim 6, Hagne further teaches the inclusion of benzalkonium chloride (i.e. a surfactant) (e.g. Examples).
Regarding Claim 7, Both Hagne and Intermed 2020 teach the inclusion of propylene glycol (i.e. a humectant) (e.g. Examples).
Regarding Claim 14, Hagne further teaches the inclusion of preservatives (e.g. Examples).
Regarding Claim 16, Hagne teaches that the pH is preferably 0.5-1.5 (e.g. page 4, lines 16-17).
Regarding Claim 17, as evidenced by Intermed 2019, “Clean & Boost” comprises 0.5-3 wt% of nitric acid, which is within the claimed range (e.g. page 2).
Regarding Claim 18, Intermed 2020 teaches that the FD&C is present at 1%, which is within the claimed range (e.g. page 3).
Claims 11, 15, 19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Hagne (WO 98/46194) in view of Vista Apex (“Clean & Boost® Dentin and Enamel Cleanser”; 2021) as evidenced by Intermed 2019 (“Clean & Boost SDS”; 2019) and InterMed 2020 (“510(k) Summary for Vista Dyes”; 2020), as applied to Claims 1-8, 10, 12-14, and 16-18, and further in view of Wang et al. (US 2017/0202751).
Regarding Claims 1-8, 10, 12-14 and 16-18, the teachings of Hagne, Vista Apex, and Intermed 2020 are described supra. Hagne teaches the inclusion of 1-5 wt% of a viscosity-enhancing agent (e.g. Example), but does not teach that the agent is a polyvinyl alcohol polymer. This is made up for by the teachings of Wang et al.
Wang et al. teach dental etchant compositions comprising at least one acid, processes for making the same, and methods for using the dental etchant compositions (e.g. abstract). Wang et al. teach that “the acid in the dental etchant compositions may be damaging to the tissues adjacent to the tooth. Accordingly, in such aspects, in an attempt to minimize the flow of the dental etchant compositions from the tooth surface to the surrounding tissues it may be desirable to increase the viscosity of the dental etchant compositions, e.g., by formulating the dental etchant composition as a gel or a paste…Any rheology modifiers known to one skilled in the art can be used as long as such a rheology modifier does not interfere with the function of the dentin collagen cross-linking agents and/or the acid. For example…polyvinyl alcohol” (e.g. paragraph 0026).
Regarding Claims 11 and 15, it would have been obvious to one of ordinary skill in the art at the time of filing to select the polyvinyl alcohol of Wang et al. as the thickener of Hagne. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results. Simple substitution of one known element for another to obtain predictable results is obvious. In addition, one of ordinary skill in the art would have been motivated to select polyvinyl alcohol in order to obtain a viscosity high enough to minimize the flow of the dental etchant compositions from the tooth surface to the surrounding tissues, as taught by Wang et al.
Regarding Claims 19 and 21, as evidenced by Intermed 2019, “Clean & Boost” comprises 1-10 wt% hydroxyethyl methacrylate, 1-5 wt% isopropanol, and 0.5-3 wt% of nitric acid, which are within or overlap the claimed ranges (e.g. page 2). Hagne teaches the inclusion of 1-5 wt% of a viscosity-enhancing agent, which overlaps with the claimed range (e.g. Example). And Intermed 2020 teaches that the FD&C is present at 1%, which is within the claimed range (e.g. page 3). 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) (MPEP 2144.05.I). Hagne teaches that the pH is preferably 0.5-1.5 (e.g. page 4, lines 16-17).
Response to Arguments
Applicant's arguments filed 9/17/26 have been fully considered but they are not persuasive.
Applicant argues that because the Examiner relied on four references they relied on impermissible hindsight reasoning.
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 the instant case, it would have been obvious to one of ordinary skill in the art at the time of filing to combine the etchant of Vista Apex and the stain of Intermed 2020 as suggested by Hagne. Hagne discloses the motivation for and the combination of an indicator and etching composition to be used simultaneously. One of ordinary skill in the art would have predicted success as all of the compositions are useful as dental compositions and one of ordinary skill would have been motivated in order to provide the benefits of a single step composition as taught by Hagne, with an etchant that is kinder to tissues, as taught by Vista Apex, and the dye of Intermed 2020.
Applicant further argues that the Examiner's motivation to combine is insufficient because Vista Apex (Clean & Boost) and InterMed 2020 (Vista Dyes) are separate products designed for separate functions.
This is not found persuasive. As described supra, Hagne discloses the motivation for and the combination of an indicator and etching composition to be used simultaneously. “When a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Applicant further argues that Hagne's composition performs only two functions (etching and detection), not the three simultaneous functions (etching, cleansing, and caries indication) recited in the amended claims.
This is not found persuasive. Applicant is arguing the intended use of the claimed composition. As described supra, the claimed ingredients and amounts thereof are disclosed by Hagne, Vista Apex, and InterMed 2020 as evidenced by Intermed 2019. If additional ingredients or amounts thereof are required for cleaning they should be recited in the claim. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Applicant argues the specification further discloses that the claimed compositions achieve unexpected results. Specifically, as disclosed in paragraph [006] and the Figure, the claimed composition (Formula A) provides improved shear bond strength of greater than 35% compared to a conventional protocol using a 37% phosphoric acid etch. This result is unexpected because a person of ordinary skill in the art would predict that a milder acid such as nitric acid would produce equal or lesser bond strength compared to the stronger phosphoric acid etchant.
This is not found persuasive. The Figure and [006] compare Formula A to a standard protocol where a 37% phosphoric acid etch is used. First, the instant Specification does not disclose the ingredients of the standard protocol composition, therefore it is unclear if Applicant has compared to the closest prior art. Second, Applicant has not provided standard deviation or statistical analysis. It is unclear if a normalized shear bond measurement of around 1.3 vs around 1 is a significant and unexpected difference. Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The evidence relied upon should establish “that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance.” Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). In addition, it was known in the art that nitric acid was an effective mineral acid, as it is used in the composition of Vista Apex (“Clean & Boost® Dentin and Enamel Cleanser”).
Applicant further argues that Wang to the combination makes the reconstruction even more attenuated by requiring five separate teachings drawn from four references to arrive at the claimed invention. This increasing complexity is strong evidence of impermissible hindsight reasoning.
This is not found persuasive. In response to applicant's argument that the examiner has combined an excessive number of references, reliance on a large number of references in a rejection does not, without more, weigh against the obviousness of the claimed invention. See In re Gorman, 933 F.2d 982, 18 USPQ2d 1885 (Fed. Cir. 1991). As described supra, it would have been obvious to one of ordinary skill in the art at the time of filing to select the polyvinyl alcohol of Wang et al. as the thickener of Hagne. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results. Simple substitution of one known element for another to obtain predictable results is obvious. In addition, one of ordinary skill in the art would have been motivated to select polyvinyl alcohol in order to obtain a viscosity high enough to minimize the flow of the dental etchant compositions from the tooth surface to the surrounding tissues, as taught by Wang et al.
Accordingly, the rejections are maintained.
Conclusion
No claim is allowed.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE PLOURDE BABSON whose telephone number is (571)272-3055. The examiner can normally be reached M-Th 8-4:30; F 8-12:30.
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/NICOLE P BABSON/ Primary Examiner, Art Unit 1619
