DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/22/2026 has been entered.
Applicants' arguments, filed 01/22/2026 have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 .
Priority
The instant application claims domestic priority to PRO 63/150,257 filed 02/17/2021.
Claim Interpretation
“The term “D-mannose” is understood to refer to molecules of mannose that rotate plane-polarized light in a dextrorotatory manner. This is the enantiomer of mannose that occurs naturally. Prior art teachings of “mannose” will be understood to read on the required “D-mannose” because it is the dextrorotatory enantiomer that occurs naturally. See e.g. the instant specification on page 11, paragraph [0018], which appears to indicate that mannose and D-mannose refer to the same compound. The examiner understands that mannose in an amount of 0.1% to 1% is an effective amount to promote the growth of beneficial and endogenous bacteria in the oral cavity.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
A) Claims 1, 6-7, 9-11, 13-17, 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Stettler et al. (US Patent Application Publication 2016/0317414 A1) in view of Fruge et al. (US Patent Application Publication 20060140879 A1).
Stettler recites an oral care composition comprising an effective amount of at least one saccharide prebiotic for use in selectively promoting, in an oral cavity: growth, metabolic activity or colonization of bacteria that have beneficial effects on oral health, relative to growth, metabolic activity or colonization of pathogenic oral bacteria (Stettler at claim 1). Stettler further recites wherein the saccharide prebiotic can be N-acetyl-D-mannosamine (Stettler at claim 5). Stettler recites wherein the composition promotes the growth in the oral cavity of one or more beneficial endogenous bacterial species, wherein said species are one or more selected from the group consisting of Streptococcus mitis, Streptococcus salivarius, Streptococcus sanguinis, Actinomyces viscosus, Veillonella parvula, Streptococcus gordonii, Capnocytophaga sputigena and Actinomyces naeslundii (Stettler at claim 8). Stettler recites wherein the composition negatively affects the growth in the oral cavity of one or more pathogenic bacterial species, wherein said species are one or more selected from the group consisting of: Streptococcus mutans, Prevotella intermedia, Porphyromonas gingivalis, Fusobacterium nucleatum, Tannerella forsythia, Aggregatibacter actinomycetemcomitans, and Streptococcus sobrinus (Stettler at claim 9). Stettler recites wherein the composition further comprises at least one species of bacteria that has beneficial effects on oral health (Stettler at claim 10). Stettler further recites wherein the species of bacteria that has beneficial effects on oral health is selected from Streptococcus mitis, Streptococcus salivarius, Streptococcus sanguinis, Actinomyces viscosus, Veillonella parvula, Streptococcus gordonii, Capnocytophaga sputigena, Actinomyces naeslundii and combinations thereof (Stettler at claim 11). Stettler recites wherein the composition is a mouthwash, toothpaste, tooth gel, tooth powder, non-abrasive gel, mousse, foam, mouth spray, lozenge, oral tablet, dental implement, or pet care product (Stettler at claim 12). Stettler recites a method for selectively promoting, in an oral cavity: growth, metabolic activity or colonization of bacteria that have beneficial effects on oral health, relative to growth, metabolic activity or colonization of pathogenic oral bacteria, comprising administering to the oral cavity an oral care composition comprising an effective amount of at least one saccharide prebiotic (Stettler at claim 18). Stettler recites a method for selectively promoting, in an oral cavity, biofilm formation by bacteria that have beneficial effects on oral health, relative to biofilm formation by pathogenic oral bacteria, comprising administering to the oral cavity an oral care composition comprising an effective amount of at least one saccharide prebiotic (Stettler at claim 15). Stettler recites a method for preventing or mitigating one or more of gingivitis, periodontitis, peri-implantitis, peri-implant mucositis, necrotizing gingivitis, necrotizing periodontitis and caries in a subject in need thereof, by selectively promoting in the oral cavity of the subject the growth, metabolic activity or colonization of bacteria that have beneficial effects on oral health, relative to growth, metabolic activity or colonization of pathogenic oral bacteria, comprising administering to the oral cavity an oral care composition comprising an effective amount of at least one saccharide prebiotic(Stettler at claim 16). Stettler further discloses two compositions as example embodiments seen below wherein the saccharide prebiotic may be N-acetyl-D-mannosamine;
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(Stettler at [0148]).
The teachings of Stettler differ from that of instant claim 1 insofar as they do not teach the use of D-mannose. The teachings of Fruge cure this deficit.
Fruge teaches a toothpaste (Fruge at abstract). Fruge further teaches the use of mannose as a sweetener in a range of optionally from about 0.01% to about 1% (Fruge at [0044]).
The skilled artisan would have been motivated to have combined the sweetener of Fruge with the composition of Stettler because Stettler teaches a sweetener, as of paragraph [0114] of Stettler, and Fruge indicates that mannose is a sweetener. As such, the skilled artisan would have been motivated to have added the mannose of Fruge to the composition of Stettler to have predictably sweetened the composition of Stettler with a reasonable expectation of success. See MPEP 2144.07. In the alternative, the skilled artisan would have been motivated to have substituted the mannose of Fruge in place of the compound used by Stettler for sweetening purposes in order to have predictably sweetened the composition of Stettler with a reasonable expectation of success. See MPEP 2143, Exemplary Rationale B.
Regarding instant claim 1, Stettler recites an oral care composition comprising an effective amount of at least one saccharide prebiotic for use in selectively promoting, in an oral cavity: growth, metabolic activity or colonization of bacteria that have beneficial effects on oral health, relative to growth, metabolic activity or colonization of pathogenic oral bacteria (Stettler at claim 1). Stettler further recites wherein the saccharide prebiotic can be N-acetyl-D-mannosamine (Stettler at claim 5). Stettler recites a method for preventing or mitigating one or more of gingivitis, periodontitis, peri-implantitis, peri-implant mucositis, necrotizing gingivitis, necrotizing periodontitis and caries in a subject in need thereof, by selectively promoting in the oral cavity of the subject the growth, metabolic activity or colonization of bacteria that have beneficial effects on oral health, relative to growth, metabolic activity or colonization of pathogenic oral bacteria, comprising administering to the oral cavity an oral care composition comprising an effective amount of at least one saccharide prebiotic (Stettler at claim 16). Fruge teaches a toothpaste (Fruge at abstract). Fruge further teaches the use of mannose as a sweetener in a range of optionally from about 0.01% to about 1% (Fruge at [0044]). It would have been prima facie obvious to have combined the sweetener of Stettler with the sweetener of Fruge for the predictable result of a sweetened prebiotic oral care composition. See MPEP 2144.06. Stettler teaches wherein the amount of sweetener 0.005 to 10 weight % of a sweetener, e.g., 0.01 to 10 weight % of a sweetener, e.g., 0.1 to 10 weight % of a sweetener, e.g., from 0.1 to 5 weight % of a sweetener, e.g., from 0.1 to 3 weight % of a sweetener, e.g., from 0.1 to 1 weight % of a sweetener, e.g., from 0.1 to 0.5 weight % of a sweetener (Stettler at [0114]), which overlaps with the instantly claimed range of 0.1% to 1%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I). Stettler teaches wherein the amount of saccharide prebiotic is at least 0.1%, e.g., 0.1% to 5%, e.g., about 0.5%, 1% or 2% by weight of the composition, which overlaps with the instantly claimed range of 0.1% to 1%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
As to claim 1, the examiner notes that the 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 MPEP 2144(IV). In this case, the skilled artisan would have been motivated to have used mannose, as of Fruge, in the composition administered by the method of Stettler in order to have acted as a sweetener. This does not appear to be the same reason for the use of mannose recited by the instant claims. Nevertheless, as the mannose of the prior art appears to be the same as the mannose recited by the instantly claimed invention (and in amounts that overlap with the claimed amounts), the subject matter of the prior art is understood to render the claimed subject matter prima facie obvious despite the fact that the mannose in the prior art was used for a different purpose than the mannose in the claimed invention.
Regarding instant claim 6, Stettler recites wherein the composition promotes the growth in the oral cavity of one or more beneficial endogenous bacterial species, wherein said species are one or more selected from the group consisting of Streptococcus mitis, Streptococcus salivarius, Streptococcus sanguinis, Actinomyces viscosus, Veillonella parvula, Streptococcus gordonii, Capnocytophaga sputigena and Actinomyces naeslundii (Stettler at claim 8).
Regarding instant claim 7, Stettler recites wherein the composition negatively affects the growth in the oral cavity of one or more pathogenic bacterial species, wherein said species are one or more selected from the group consisting of: Streptococcus mutans, Prevotella intermedia, Porphyromonas gingivalis, Fusobacterium nucleatum, Tannerella forsythia, Aggregatibacter actinomycetemcomitans, and Streptococcus sobrinus (Stettler at claim 9).
Regarding instant claim 9, Stettler recites wherein the composition further comprises at least one species of bacteria that has beneficial effects on oral health (Stettler at claim 10).
Regarding instant claim 10, Stettler recites wherein the composition further comprises at least one species of bacteria that has beneficial effects on oral health (Stettler at claim 10). Stettler further recites wherein the species of bacteria that has beneficial effects on oral health is selected from Streptococcus mitis, Streptococcus salivarius, Streptococcus sanguinis, Actinomyces viscosus, Veillonella parvula, Streptococcus gordonii, Capnocytophaga sputigena, Actinomyces naeslundii and combinations thereof (Stettler at claim 11).
Regarding instant claim 11, Stettler recites wherein the composition is a mouthwash, toothpaste, tooth gel, tooth powder, non-abrasive gel, mousse, foam, mouth spray, lozenge, oral tablet, dental implement, or pet care product (Stettler at claim 12).
Regarding instant claim 13-17, Stettler teaches two compositions (Stettler at [0147-0148]) with identical compositions to that of the instant applications specification Example 5. The compositions with identical compositions would have the same inherent properties, including decreasing gene expressions in bacteria and keratinocytes. See MPEP §2112(II). Further, because Stettler teaches an identical composition the new discovery of decreased gene expression would not make the instant composition patentable. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. See MPEP §2112 (I).
Regarding instant claim 19, Stettler recites a method for selectively promoting, in an oral cavity: growth, metabolic activity or colonization of bacteria that have beneficial effects on oral health, relative to growth, metabolic activity or colonization of pathogenic oral bacteria, comprising administering to the oral cavity an oral care composition comprising an effective amount of at least one saccharide prebiotic (Stettler at claim 18).
Regarding instant claim 20, Stettler recites a method for selectively promoting, in an oral cavity, biofilm formation by bacteria that have beneficial effects on oral health, relative to biofilm formation by pathogenic oral bacteria, comprising administering to the oral cavity an oral care composition comprising an effective amount of at least one saccharide prebiotic (Stettler at claim 15). Stettler further recites wherein the saccharide prebiotic can be N-acetyl-D-mannosamine (Stettler at claim 5). Fruge teaches a toothpaste (Fruge at abstract). Fruge further teaches the use of mannose as a sweetener in a range of optionally from about 0.01% to about 1% (Fruge at [0044]). It would have been prima facie obvious to have combined the sweetener of Stettler with the sweetener of Fernando for the predictable result of a sweetened prebiotic oral care composition. See MPEP 2144.06. Stettler teaches wherein the amount of sweetener 0.005 to 10 weight % of a sweetener, e.g., 0.01 to 10 weight % of a sweetener, e.g., 0.1 to 10 weight % of a sweetener, e.g., from 0.1 to 5 weight % of a sweetener, e.g., from 0.1 to 3 weight % of a sweetener, e.g., from 0.1 to 1 weight % of a sweetener, e.g., from 0.1 to 0.5 weight % of a sweetener (Stettler at [0114]), which overlaps with the instantly claimed range of 0.1% to 1%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 21, Stettler recites a method for preventing or mitigating one or more of gingivitis, periodontitis, peri-implantitis, peri-implant mucositis, necrotizing gingivitis, necrotizing periodontitis and caries in a subject in need thereof, by selectively promoting in the oral cavity of the subject the growth, metabolic activity or colonization of bacteria that have beneficial effects on oral health, relative to growth, metabolic activity or colonization of pathogenic oral bacteria, comprising administering to the oral cavity an oral care composition comprising an effective amount of at least one saccharide prebiotic (Stettler at claim 16). Stettler further recites wherein the saccharide prebiotic can be N-acetyl-D-mannosamine (Stettler at claim 5). Fruge teaches a toothpaste (Fruge at abstract). Fruge further teaches the use of mannose as a sweetener in a range of optionally from about 0.01% to about 1% (Fruge at [0044]). It would have been prima facie obvious to have combined the sweetener of Stettler with the sweetener of Fernando for the predictable result of a sweetened prebiotic oral care composition. See MPEP 2144.06. Stettler teaches wherein the amount of sweetener 0.005 to 10 weight % of a sweetener, e.g., 0.01 to 10 weight % of a sweetener, e.g., 0.1 to 10 weight % of a sweetener, e.g., from 0.1 to 5 weight % of a sweetener, e.g., from 0.1 to 3 weight % of a sweetener, e.g., from 0.1 to 1 weight % of a sweetener, e.g., from 0.1 to 0.5 weight % of a sweetener (Stettler at [0114]), which overlaps with the instantly claimed range of 0.1% to 1%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
B) Claims 1, 6-7, 9-11, 13-17, 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Stettler et al. (US Patent Application Publication 2016/0317414 A1) in view of Garcia-Rodenas et al (US Patent Application Publication 20180280454A1).
Stettler recites an oral care composition comprising an effective amount of at least one saccharide prebiotic for use in selectively promoting, in an oral cavity: growth, metabolic activity or colonization of bacteria that have beneficial effects on oral health, relative to growth, metabolic activity or colonization of pathogenic oral bacteria (Stettler at claim 1). Stettler further recites wherein the saccharide prebiotic can be N-acetyl-D-mannosamine (Stettler at claim 5). Stettler recites wherein the composition promotes the growth in the oral cavity of one or more beneficial endogenous bacterial species, wherein said species are one or more selected from the group consisting of Streptococcus mitis, Streptococcus salivarius, Streptococcus sanguinis, Actinomyces viscosus, Veillonella parvula, Streptococcus gordonii, Capnocytophaga sputigena and Actinomyces naeslundii (Stettler at claim 8). Stettler recites wherein the composition negatively affects the growth in the oral cavity of one or more pathogenic bacterial species, wherein said species are one or more selected from the group consisting of: Streptococcus mutans, Prevotella intermedia, Porphyromonas gingivalis, Fusobacterium nucleatum, Tannerella forsythia, Aggregatibacter actinomycetemcomitans, and Streptococcus sobrinus (Stettler at claim 9). Stettler recites wherein the composition further comprises at least one species of bacteria that has beneficial effects on oral health (Stettler at claim 10). Stettler further recites wherein the species of bacteria that has beneficial effects on oral health is selected from Streptococcus mitis, Streptococcus salivarius, Streptococcus sanguinis, Actinomyces viscosus, Veillonella parvula, Streptococcus gordonii, Capnocytophaga sputigena, Actinomyces naeslundii and combinations thereof (Stettler at claim 11). Stettler recites wherein the composition is a mouthwash, toothpaste, tooth gel, tooth powder, non-abrasive gel, mousse, foam, mouth spray, lozenge, oral tablet, dental implement, or pet care product (Stettler at claim 12). Stettler recites a method for selectively promoting, in an oral cavity: growth, metabolic activity or colonization of bacteria that have beneficial effects on oral health, relative to growth, metabolic activity or colonization of pathogenic oral bacteria, comprising administering to the oral cavity an oral care composition comprising an effective amount of at least one saccharide prebiotic (Stettler at claim 18). Stettler recites a method for selectively promoting, in an oral cavity, biofilm formation by bacteria that have beneficial effects on oral health, relative to biofilm formation by pathogenic oral bacteria, comprising administering to the oral cavity an oral care composition comprising an effective amount of at least one saccharide prebiotic (Stettler at claim 15). Stettler recites a method for preventing or mitigating one or more of gingivitis, periodontitis, peri-implantitis, peri-implant mucositis, necrotizing gingivitis, necrotizing periodontitis and caries in a subject in need thereof, by selectively promoting in the oral cavity of the subject the growth, metabolic activity or colonization of bacteria that have beneficial effects on oral health, relative to growth, metabolic activity or colonization of pathogenic oral bacteria, comprising administering to the oral cavity an oral care composition comprising an effective amount of at least one saccharide prebiotic(Stettler at claim 16). Stettler further discloses two compositions as example embodiments seen below wherein the saccharide prebiotic may be N-acetyl-D-mannosamine;
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(Stettler at [0148]).
The teachings of Stettler differ from that of instant claim 1 insofar as they do not teach the use of D-mannose. The teachings of Garcia-Rodenas cure this deficit.
Garcia-Rodenas differs from instant claim 1 insofar as it does not specifically teach the specific probiotic bacteria to use in the composition. The teachings of Stettler cure this deficit.
Garcia-Rodenas teaches the prevention or treatment of microbiota dysbiosis, in particular, decreased levels of Actinobacteria and increased levels of Proteobacteria, in young mammals and in the prevention or treatment of disorders associated therewith (Garcia-Rodenas at abstract). Garcia-Rodenas teaches the use of mannose as a prebiotic (Garcia-Rodenas at [0095]) in a range of 0.3% to 10%. Garcia-Rodenas further teaches the treatment of microbiota dysbiosis, includes re-establishing a microbiota not significantly different from that observed healthy young mammals, who are not experiencing microbiota dysbiosis. This means that the various bacterial populations are re-established in their optimal relative abundance. (Garcia-Rodenas at [0017]).
It would have been prima facie obvious for one of ordinary skill in the art to have combined the prebiotic sugar of Garcia-Rodenas with the prebiotic sugar of Stettler for the predictable result of a composition with prebiotic sugar. See MPEP2144.06(I). It would have been prima facie obvious for one of ordinary skill in the art to have substituted the prebiotic sugar of Garcia-Rodenas for the prebiotic sugar of Stettler for the predictable result of a composition with prebiotic sugar. See MPEP2144.06(II).
Regarding instant claim 1, Stettler recites an oral care composition comprising an effective amount of at least one saccharide prebiotic for use in selectively promoting, in an oral cavity: growth, metabolic activity or colonization of bacteria that have beneficial effects on oral health, relative to growth, metabolic activity or colonization of pathogenic oral bacteria (Stettler at claim 1). Stettler further recites wherein the saccharide prebiotic can be N-acetyl-D-mannosamine (Stettler at claim 5). Stettler recites a method for preventing or mitigating one or more of gingivitis, periodontitis, peri-implantitis, peri-implant mucositis, necrotizing gingivitis, necrotizing periodontitis and caries in a subject in need thereof, by selectively promoting in the oral cavity of the subject the growth, metabolic activity or colonization of bacteria that have beneficial effects on oral health, relative to growth, metabolic activity or colonization of pathogenic oral bacteria, comprising administering to the oral cavity an oral care composition comprising an effective amount of at least one saccharide prebiotic (Stettler at claim 16). Garcia-Rodenas teaches the use of mannose as a prebiotic (Garcia-Rodenas at [0095]) in a range of 0.3% to 10%. It would have been prima facie obvious for one of ordinary skill in the art to have combined the prebiotic sugar of Garcia-Rodenas with the prebiotic sugar of Stettler for the predictable result of a composition with prebiotic sugar. See MPEP2144.06(I). Stettler teaches wherein the amount of saccharide prebiotic is at least 0.1%, e.g., 0.1% to 5%, e.g., about 0.5%, 1% or 2% by weight of the composition, which overlaps with the instantly claimed range of 0.1% to 1%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 6, Stettler recites wherein the composition promotes the growth in the oral cavity of one or more beneficial endogenous bacterial species, wherein said species are one or more selected from the group consisting of Streptococcus mitis, Streptococcus salivarius, Streptococcus sanguinis, Actinomyces viscosus, Veillonella parvula, Streptococcus gordonii, Capnocytophaga sputigena and Actinomyces naeslundii (Stettler at claim 8).
Regarding instant claim 7, Stettler recites wherein the composition negatively affects the growth in the oral cavity of one or more pathogenic bacterial species, wherein said species are one or more selected from the group consisting of: Streptococcus mutans, Prevotella intermedia, Porphyromonas gingivalis, Fusobacterium nucleatum, Tannerella forsythia, Aggregatibacter actinomycetemcomitans, and Streptococcus sobrinus (Stettler at claim 9).
Regarding instant claim 9, Stettler recites wherein the composition further comprises at least one species of bacteria that has beneficial effects on oral health (Stettler at claim 10).
Regarding instant claim 10, Stettler recites wherein the composition further comprises at least one species of bacteria that has beneficial effects on oral health (Stettler at claim 10). Stettler further recites wherein the species of bacteria that has beneficial effects on oral health is selected from Streptococcus mitis, Streptococcus salivarius, Streptococcus sanguinis, Actinomyces viscosus, Veillonella parvula, Streptococcus gordonii, Capnocytophaga sputigena, Actinomyces naeslundii and combinations thereof (Stettler at claim 11).
Regarding instant claim 11, Stettler recites wherein the composition is a mouthwash, toothpaste, tooth gel, tooth powder, non-abrasive gel, mousse, foam, mouth spray, lozenge, oral tablet, dental implement, or pet care product (Stettler at claim 12).
Regarding instant claim 13-17, Stettler teaches two compositions (Stettler at [0147-0148]) with identical compositions to that of the instant applications specification Example 5. The compositions with identical compositions would have the same inherent properties, including decreasing gene expressions in bacteria and keratinocytes. See MPEP §2112(II). Further, because Stettler teaches an identical composition the new discovery of decreased gene expression would not make the instant composition patentable. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. See MPEP §2112 (I).
Regarding instant claim 19, Stettler recites a method for selectively promoting, in an oral cavity: growth, metabolic activity or colonization of bacteria that have beneficial effects on oral health, relative to growth, metabolic activity or colonization of pathogenic oral bacteria, comprising administering to the oral cavity an oral care composition comprising an effective amount of at least one saccharide prebiotic (Stettler at claim 18).
Regarding instant claim 20, Stettler recites a method for selectively promoting, in an oral cavity, biofilm formation by bacteria that have beneficial effects on oral health, relative to biofilm formation by pathogenic oral bacteria, comprising administering to the oral cavity an oral care composition comprising an effective amount of at least one saccharide prebiotic (Stettler at claim 15). Stettler further recites wherein the saccharide prebiotic can be N-acetyl-D-mannosamine (Stettler at claim 5). Garcia-Rodenas teaches the use of mannose as a prebiotic (Garcia-Rodenas at [0095]) in a range of 0.3% to 10%. It would have been prima facie obvious for one of ordinary skill in the art to have combined the prebiotic sugar of Garcia-Rodenas with the prebiotic sugar of Stettler for the predictable result of a composition with prebiotic sugar. See MPEP2144.06(I).
Regarding instant claim 21, Stettler recites a method for preventing or mitigating one or more of gingivitis, periodontitis, peri-implantitis, peri-implant mucositis, necrotizing gingivitis, necrotizing periodontitis and caries in a subject in need thereof, by selectively promoting in the oral cavity of the subject the growth, metabolic activity or colonization of bacteria that have beneficial effects on oral health, relative to growth, metabolic activity or colonization of pathogenic oral bacteria, comprising administering to the oral cavity an oral care composition comprising an effective amount of at least one saccharide prebiotic (Stettler at claim 16). Stettler further recites wherein the saccharide prebiotic can be N-acetyl-D-mannosamine (Stettler at claim 5). Garcia-Rodenas teaches the use of mannose as a prebiotic (Garcia-Rodenas at [0095]) in a range of 0.3% to 10%. It would have been prima facie obvious for one of ordinary skill in the art to have combined the prebiotic sugar of Garcia-Rodenas with the prebiotic sugar of Stettler for the predictable result of a composition with prebiotic sugar. See MPEP2144.06(I).
Relevant Prior Art
Fernando et al. (US Patent Application Publication 20190269740 A1)
Frenando teaches a composition that is applied to the subject that is in the form of a toothpaste (Frenando at claim 11). Frenando further teaches that the composition comprises a prebiotic that can be mannose in an amount from 1g/L to about 10g/L (Frenando at claim 1), assuming a density of 1 g/mL (or 1000 g/L), which is the density of water, would be about 1 to 10 grams of mannose per 1000 grams of composition, which is 0.1% to 10%. Frenando teaches the use of probiotic bacterial strains Aneurinibacillus migulanus and Aneurinibacillus aneurinilyticus and their extracts for inhibiting the growth of Streptococcus bovis, Fusobacterium necrophorum and Acranobacterium (Actinomyces) pyogenes (Frenando at [0002]). Therefore, Frenando teaches a toothpaste composition that increases beneficial bacterial, inhibits detrimental bacteria and uses mannose as a prebiotic.
Hyde et al. (US Patent Application Publication 20150058368 A1)
Hyde teaches the use of mannose as a prebiotic (Hyde at [0061]).
Andersen et al. (US Patent Application Publication 20100104688 A1)
Andersen teaches mannose as a prebiotic “In an embodiment of the invention, said active ingredient comprises a prebiotic, such as fructose, galactose, mannose, insulin or soy.” (Andersen at [0175]). Andersen also teaches the use of mannose as a free-flowing agent (Andersen at Example 6), free flowing agents are used in an amount between 0.01% of the composition (Andersen at [0219-0221]).
Al-Ghazzewi et al. (US Patent Application Publication 20080226603 A1).
Al-Ghazzewi teaches the use of mannose as a prebiotic (Al-Ghazzewi whole document).
The relevant prior art is presented for completeness of the record and compact prosecution. In selecting the references to be used in rejecting the claims, the examiner should carefully compare the references with one another and with the applicant’s disclosure to avoid an unnecessary number of rejections over similar references. The examiner is not called upon to cite all references that may be available, but only the "best." (See 37 CFR 1.104(c).) Multiplying references, any one of which is as good as, but no better than, the others, adds to the burden and cost of prosecution and should therefore be avoided. See MPEP 904.03, third paragraph in section. The examiner takes the position that Fernando, Hyde, Andersen, or Al-Ghazzewi appears to be just as good as Fruge or Garcia-Rodenas. As such, no rejection over Fernando, Hyde, Andersen, or Al-Ghazzewi has been written in view of the provisions of MPEP 904.03.
Response to Arguments and Affidavit
Applicant's arguments filed 06/25/2025 have been fully considered but they are not persuasive.
Applicant argues that the objective of the method is an element of the claim and therefore the obviousness rejection should be withdrawn.
The Examiner does not agree. The mannose of Fruge would necessarily preform the function of mannose described in the instant invention even as it sweetens the composition. The mannose of Fruge is identical to the mannose of the instant application and it is applied to the mouth. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). See MPEP 2112.01(I). "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP2112.01(II). The mannose of Fruge would necessarily preform the function of mannose described in the instant invention even as it sweetens the composition. Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986) See MPEP 2112.02(I). See also Stettler in view of Garcia-Rodenas. As such, the applicant’s arguments are not persuasive and the obviousness rejection is maintained.
Applicant and Affidavit argue that neither Stettler nor Fruge teach that mannose is prebiotic and that saccharides are not immediately predictable in action as such the obviousness rejection should be withdrawn.
The Examiner does not agree. Fruge teaches a toothpaste (Fruge at abstract). Fruge further teaches the use of mannose as a sweetener in a range of optionally from about 0.01% to about 1% (Fruge at [0044]). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I). It would have been prima facie obvious to have combined the sweetener of Stettler with the sweetener of Fruge for the predictable result of a sweetened prebiotic oral care composition. See MPEP 2144.06. Fruge does not need to teach the mannose for the same reason or to fix the same problem as the instant invention. The 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). See MPEP 2144(IV). The mannose of Fruge would necessarily preform the function of mannose described in the instant invention even as it sweetens the composition. The mannose of Fruge is identical to the mannose of the instant application and it is applied to the mouth. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). See MPEP 2112.01(I). "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP2112.01(II). The mannose of Fruge would necessarily preform the function of mannose described in the instant invention even as it sweetens the composition. Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986) See MPEP 2112.02(I). Stettler further teaches a wide range of prebiotic saccharides
“Saccharide prebiotics for use in the present invention are sugars or sugar derivatives, e.g., amino sugars or sugar alcohols, for example mono-, di- or tri-saccharides (including amino-saccharides and sugar alcohols) which are orally acceptable (i.e., non-toxic at relevant concentrations in an oral care formulation) and which promote the growth of beneficial oral bacteria, while simultaneously negatively affecting the growth of pathogenic oral bacteria. In particular embodiments, the saccharide prebiotic is selected from D-turanose, D-melezitose, D-lactitol, myo-inositol, N-acetyl-D-mannosamine and mixtures thereof. D-turanose is a disaccharide, also known as α-D-glucopyranosyl-(1→3)-α-D-fructofuranose or (3S,4R,5R)-1,4,5,6-tetrahydroxy-3-[(2R,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyhexan-2-one. D-melezitose is a nonreducing trisaccharide also known as melicitose, which can be partially hydrolyzed to provide turanose and glucose. Its IUPAC name is (2R,3R,4S,5S,6R)-2-[[(2S,3S,4R,5R)-4-hydroxy-2,5-bis(hydroxymethyl)-3-[[(2R,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)-2-tetrahydropyranyl]oxy]-2-tetrahydrofuranyl]oxy]-6-(hydroxymethyl)tetrahydropyran-3,4,5-triol. D-lactitol comprises a monosaccharide linked to a sugar alcohol. D-lactitol is also known as 4-O-α-D-galactopyranosyl-D-glucitol. Myo-inositol is a cyclohexane bearing a hydroxyl group on each carbon, and is a metabolite of glucose, having the same elemental composition (C6H12O6). It is formally known as (1R,2R,3S,4S,5R,6S)-cyclohexane-1,2,3,4,5,6-hexol. N-acetyl-D-mannosamine is an acetylated amino-monosaccharide, more formally known as 2-acetamido-2-deoxy-D-mannose”
(Stettler at [0093]) including specialized D-mannose in the form of N-acetyl-D-mannosamine, an acetylated amino-monosaccharide, more formally known as 2-acetamido-2-deoxy-D-mannose. Stettler teaches a wide range of saccharides promote the growth of beneficial oral bacteria, while simultaneously negatively affecting the growth of pathogenic oral bacteria therefore it would be reasonable to try another saccharide. See MPEP2143(I). See also Stettler in view of Garcia-Rodenas. As such, the applicant’s and affidavits arguments are not persuasive and the obviousness rejection is maintained.
Applicant argues that mannose is not in the examples of Fruge, Fruge teaches a wider range of sweeteners that would be optimized for flavor, and that mannose is one of a larger list of sweeteners therefore the obviousness rejection should be withdrawn.
The Examiner does not agree. The prior art of Fruge is also good for all it contains including general teachings. "The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983). See MPEP 2123(I). Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). See MPEP2123 (II). It would have been prima facie obvious to have selected a sweetener from a finite list of sweeteners. See MPEP2143(I). Fruge teaches the use of mannose within a finite list in a range overlapping the range taught by the prior art. Fruge further teaches the use of mannose as a sweetener in a range of optionally from about 0.01% to about 1% (Fruge at [0044]). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I). It would have been prima facie obvious to have combined the sweetener of Stettler with the sweetener of Fruge for the predictable result of a sweetened prebiotic oral care composition. See MPEP 2144.06. See also Stettler in view of Garcia-Rodenas. As such, the applicant’s arguments are not persuasive and the obviousness rejection is maintained.
Applicant argues that the range disclosed is specific to the prebiotic dosage range and that Stettler teaches a range for prebiotic saccharides not sweeteners, that the data of the specification provides unexpected results, and that the Examiner used impermissible hindsight and therefore the obviousness rejection should be withdrawn.
The Examiner does not agree. 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).
With regards to the unexpected results. The instant claims do not currently represent the narrower scope of the data provided in the specification. The specification has data on specific ranges of specific bacteria and their specific genes as well as specific toothpaste embodiments that provide for a more detailed list of components and their ranges. Currently, the independent instant claim only requires a composition have 0.1 to 1% mannose. The independent instant claim does not provide for a range of effect on the specific bacteria or the bacteria’s specific genes. Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980). See MPEP 716.02(d). With regards to the unexpected results. A case of unexpected results has not yet been established. 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). See MPEP 716.02(I). The burden is on the applicant to explain the statistical significance and practical significance of the data which to the Examiners understanding has not yet been explained. "[A]ppellants have the burden of explaining the data in any declaration they proffer as evidence of non-obviousness." Ex parte Ishizaka, 24 USPQ2d 1621, 1624 (Bd. Pat. App. & Inter. 1992). See MPEP716.02(b)(II).
With regards to the ranges of mannose, Fruge further teaches the use of mannose as a sweetener in a range of optionally from about 0.01% to about 1% (Fruge at [0044]). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I). It would have been prima facie obvious to have combined the sweetener of Stettler with the sweetener of Fruge for the predictable result of a sweetened prebiotic oral care composition. See MPEP 2144.06. Stettler teaches wherein the amount of sweetener 0.005 to 10 weight % of a sweetener, e.g., 0.01 to 10 weight % of a sweetener, e.g., 0.1 to 10 weight % of a sweetener, e.g., from 0.1 to 5 weight % of a sweetener, e.g., from 0.1 to 3 weight % of a sweetener, e.g., from 0.1 to 1 weight % of a sweetener, e.g., from 0.1 to 0.5 weight % of a sweetener (Stettler at [0114]), which overlaps with the instantly claimed range of 0.1% to 1%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Applicant argues that there is no motivation to combine Stettler and Fruge.
The Examiner does not agree. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the skilled artisan would have been motivated to have combined the sweetener of Fruge with the composition of Stettler because Stettler teaches a sweetener, as of paragraph [0114] of Stettler, and Fruge indicates that mannose is a sweetener. As such, the skilled artisan would have been motivated to have added the mannose of Fruge to the composition of Stettler to have predictably sweetened the composition of Stettler with a reasonable expectation of success. See MPEP 2144.07. In the alternative, the skilled artisan would have been motivated to have substituted the mannose of Fruge in place of the compound used by Stettler for sweetening purposes in order to have predictably sweetened the composition of Stettler with a reasonable expectation of success. See MPEP 2143, Exemplary Rationale B. The prior art is not required to have the exact same manner of use as long as the method, application to the subject, and composition, mannose, are the same. Furthermore, the 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 MPEP 2144(IV). The prior art can use the prebiotic D-mannose for a different reason like as a sweetener. Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. See MPEP 2145(II). The use of d-mannose within the method would have performed the same prebiotic function regardless of whether the D-mannose was intended for that specific purpose because D-mannose is inherently prebiotic which is being applied to the oral cavity. Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. See MPEP 2112.02. As such, the Applicant’s argument is not persuasive and the obviousness rejection stands.
Terminal Disclaimer
The terminal disclaimer filed on 05/16/2023 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of Patent No. 10,328,010 and Patent No. 11,419,806 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Conclusion
No claims are presently allowable.
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/AMANDA MICHELLE PETRITSCH/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612