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
Information Disclosure Statement
The information disclosure statement (IDS) filed on 10/11/2024 has been considered here.
Status of Claims
Claims 1-11 are now pending and will be examined on the merits herein.
Specification
The use of the term “Carbopol” (see page 7, line 1 of specification as filed), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 1 and 6 are objected to because of the following informalities: Fucus vesiculosus seaweed should read “Fucus vesiculosus seaweed”. 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 10-11 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.
Regarding claims 10-11, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For purposes of search and consideration, the claims are understood to be read without the “such as claim” (e.g., The kit according to claim 1, wherein said photo-activator gel comprises an antimicrobial agent in a weight percentage comprised between 0.1% and 1% relative to the total weight of the photo-activator gel).
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.
Claims 1-2 and 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over US PGPUB 20080260660 1 (Engelbrecht, 2008).
In regards to claims 1 and 4-5, Engelbrecht teaches a light activated teeth whitening composition (see Engelbrecht, abstract). The composition is taught to comprise an oxidizing agent such as peroxide gel (see Engelbrecht, paragraphs 0020-0022), a bleaching agent (see Engelbrecht, paragraph 0019), and an activator (see Engelbrecht, paragraph 0022). It is taught that all of these components are in the form of a gel (see Engelbrecht, paragraphs 0019-0023). It is also taught that the composition is a two-component material in which the activator and the peroxide gel are separate, with the bleaching agent being in either part (see Engelbrecht, paragraph 0025). Further, it is taught that the two components of the composition are mixed immediately before being used for bleaching teeth (see Engelbrecht, paragraph 0029). The bleaching agent is taught to be riboflavin (i.e., vitamin B) (see Engelbrecht, paragraphs 0019 and 0036-0037) and used in an amount from 0.005-15% by weight and more preferably in an amount from 0.05-5% by weight (see Engelbrecht, paragraph 0027). MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Further in regards to claim 1, the peroxide gel is taught to comprise hydrogen peroxide (see Engelbrecht, paragraph 0032). The gels are taught to comprise demineralized water (i.e., purified water), glycerol (i.e., glycerin), and gel formers or thickeners (i.e., gelling agents) (see Engelbrecht, paragraphs 0033-0035).
In regards to claim 2, Engelbrecht teaches that the dye FD&C Red 40 (i.e., Allura Red) used in a bleaching composition (see Engelbrecht, paragraph 0012).
Further, as the combination of teachings of Engelbrecht would yield an identical composition as instantly claimed, the properties, such as the photo-activators substances acting as catalysts when they are exposed to blue light, in a decomposition reaction of the hydrogen peroxide into water and oxygen, increasing the generation of reactive oxygen species, of the composition would be the same. "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658. As the prior art teaches an identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Engelbrecht does not teach with sufficient specificity to anticipate and so the claims are obvious. It would be obvious to one with ordinary skill in the art before the effective filing date to rearrange the teachings of Engelbrecht with a reasonable expectation of success to obtain the composition of the instant claims.
A reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. “[W]hen 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. A person of ordinary skill in the art who is not an automaton is capable of producing the composition of the instant claims with predictable results.
Claims 3 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over US PGPUB 20080260660 1 (Engelbrecht, 2008) as applied to claims 1-2 and 4-5 above, and further in view of EP 1224925 A2 (Banerjee, 2002).
The teachings of Engelbrecht have been described supra.
The teachings of Engelbrecht are silent on the amount of FD&C Red 40 dye claimed by claim 3 and a chelating agent as claimed b claim 11.
In regards to claims 1 and 3, Banerjee teaches a dental bleaching gel composition comprising dye and a chelating agent (see Banerjee, abstract; Table 1). Banerjee teaches that the dye is FD&C Red 40 (i.e., Allura Red) (see Banerjee, paragraph 0017) in an amount from 0.015-0.04% w/v (see Banerjee, Table 1). MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
The composition is also taught to comprise a chelating agent (i.e., edetate disodium) (see Banerjee, paragraph 0016) in an amount from 0.1-0.05% w/v (see Banerjee, Table 1). MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
In regards to claims 3 and 11, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Engelbrecht and Banerjee to formulate the composition as instantly claimed as Engelbrecht teaches that the use of a dye in a bleaching gel is known in the art and Banerjee teaches the amounts for the dye to be used in a bleaching gel. Further, the chelating agent is taught to be a stabilizer for the composition providing the benefit of acting as scavengers of errant metal ions, which can potentially destabilize the hydrogen peroxide (see Banerjee, paragraph 0016). "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). One with ordinary skill in the art would be motivated to combine the gel of Engelbrecht with the dye and chelating agent of Banerjee according to the known method of making a two part gel dental whitening composition (see Engelbrecht, paragraphs 0039-0043) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over US PGPUB 20080260660 1 (Engelbrecht, 2008) as applied to claims 1-2 and 4-5 above, and further in view of US PGPUB 20120258058 A1 (Herrmann, 2012) as evidenced by El-Beltagi (2022).
The teachings of Engelbrecht have been described supra.
The teachings of Engelbrecht are silent on the use of Fucus vesiculosus seaweed as claimed by claim 6.
Herrman teaches a dental gel among other oral compositions (see Herrman, paragraph 0091) comprising Extrapone Seawood, which comprises potassium iodide and Fucus vesiculosus extract in an amount of 2.5% by weight (see Herrman, Table 5, formulation 11 for example). While formulation 11 is not directly taught as a oral composition, El-Beltagi teaches that Fucus vesiculosus is known to have antioxidant activity (see El-Beltagi, Table 1). The composition of Herrman is taught to comprise antioxidants (see Herrman, paragraph 0098) in an amount from 0.01 to 20 wt.% and more preferably from 0.2 to 5 wt.% based on the total weight of the product (see Herrman, paragraph 0208). MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
In regards to claim 6, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Engelbrecht and Herrman to formulate the composition as instantly claimed as the use of antioxidant compounds is known in dental compositions as taught by Herrman. "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). One with ordinary skill in the art would be motivated to combine the gel of Engelbrecht with the Fucus vesiculosus of Herrman according to the known method of making a two part gel dental whitening composition (see Engelbrecht, paragraphs 0039-0043) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over US PGPUB 20080260660 1 (Engelbrecht, 2008) in view of US PGPUB 20120258058 A1 (Herrmann, 2012) as applied to claims 1-2 and 4-6 above, and further in view of US PGPUB 20070190483 A1 (Larsen, 2207) as evidenced by El-Beltagi (2022).
The teachings of Engelbrecht and Herrman have been described supra.
The teachings of Engelbrecht and Herrman are silent on the amount of potassium iodide as claimed by claim 7.
Larsen teaches the use of potassium iodide and hydrogen peroxide in a two part bleach or whitener gel for teeth (see Larsen, abstract; paragraphs 0019 and 0021-0022; figures 1-6). In regards to the amount of potassium iodide, it is noted that that the amount of potassium iodide is based on the amount of hydrogen peroxide as the potassium iodide breaks down the peroxide to form reactive oxygen species to break down organic molecules that produce stains on teeth, while also leaving a negligible amount of free iodine in solution after bleaching is done (see Larsen, paragraphs 0019-0020), one with ordinary skill in the art would understand that the amount of potassium iodide can be changed as needed according to the amount of hydrogen peroxide and final concentration of free iodine. One with ordinary skill in the art would understand that the amount of potassium iodide is considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed amount of potassium iodide cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, amount of potassium iodide Larsen to obtain the desired balance between the amount of hydrogen peroxide and concentration of free iodine as taught by Larsen (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over US PGPUB 20080260660 1 (Engelbrecht, 2008) as applied to claims 1-2 and 4-5 above, and further in view of US PGPUB 20080008729 A1 (Swaine, 2008).
The teachings of Engelbrecht have been described supra.
The teachings of Engelbrecht are silent on the composition comprising citronellol and an antimicrobial agent, as claimed by claims 8-10.
In regards to claims 8-9, Swaine teaches oral care compositions that remove and prevent staining of teeth or provide tooth whitening (see Swaine, paragraph 0003-0004) in the form of a gel (see Swaine, paragraphs 0022-0023). The composition comprises hydrogen peroxide (see Swaine, paragraph 0084). The composition is taught to comprise a flavor oil, such as rose, geranium, or citronella, all of which comprise citronellol (see Swaine, paragraph 0026). The flavoring oil is taught to be used in an amount from 0.001% to about 5% by weight of the composition (see Swaine, paragraph 0035). MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
In regards to claim 10, the composition is taught to comprise an antimicrobial agent in an amount from 0.01% to about 5.0% by weight of the composition. MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
In regards to claims 8-10, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Engelbrecht and Swaine to formulate the composition as instantly claimed as Swaine teaches that citronellol and an antimicrobial agent are known to be used in dental gels, particularly for teeth whitening. "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). One with ordinary skill in the art would be motivated to combine the gel of Engelbrecht with teachings of Swaine according to the known method of making a two part gel dental whitening composition (see Engelbrecht, paragraphs 0039-0043) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
Conclusion
No claims allowed.
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/ISIS A GHALI/Primary Examiner, Art Unit 1611
/A.A.A./ Examiner, Art Unit 1611
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