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 . Claims included in the prosecution are claims 1, 4, 5, 8, 9, 11, 12, 15-23, 35 and 36.
Applicants' arguments, filed 06/12/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
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, 4, 5, 8, 9, 11, 12, 15-23, 35 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Stettler et al. (US 2016/0317414, Nov. 3, 2016) (hereinafter Stettler) in view of Sasaki et al. (US 2005/0118273, Jun. 2, 2005) (hereinafter Sasaki).
Stettler discloses method of enhancing a beneficial oral bacteria and decreasing harmful oral bacteria comprising administering oral care compositions comprising a saccharide prebiotic (abstract). Stettler tested a large number of sugar derivatives to identify substrates that would selectively favor the growth of beneficial bacteria while directly or indirectly suppressing the growth of harmful bacteria (¶ [0006]). The oral care composition comprising a saccharide prebiotic is found to increase the growth of Streptococcus mitis, Streptococcus salivarius, Streptococcus sanguinis, Actinomyces viscosus, Veillonella parvula, Streptococcus gordonii, Capnocytophaga sputigena and Actinomyces naeslundii. The saccharide prebiotics negatively affect the growth of Streptococcus mutans, Prevotella intermedia, Porphyromonas gingivalis, Fusobacterium nucleatum, Tannerella forsythia, Aggregatibacter actinomycetemcomitans, and Streptococcus sobrinus (¶ [0007]). The composition can further comprise at least one species of bacteria that has beneficial effects on oral health, such as Streptococcus mitis, Streptococcus salivarius, Streptococcus sanguinis, Actinomyces viscosus, Veillonella parvula, Streptococcus gordonii, Capnocytophaga Sputigena, Actinomyces naeslundii and combinations thereof (¶ [0026]-[0027]). The oral care composition may be a mouthwash, toothpaste, tooth gel, tooth powder, non-abrasive gel, mousse, foam, mouth spray, lozenge, oral tablet, or dental implement (¶ [0041]). The amount of saccharide prebiotic is 0.1% to 5% by weight of the composition (claim 6). The oral care composition selectively promotes 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 (¶ [0081]). Additionally, the oral care composition selectively promotes biofilm formation by bacteria that have beneficial effects on oral health, relative to biofilm formation by pathogenic oral bacteria (¶ [0082]). Further provided is a method of preventing or mitigating one or more of gingivitis, periodontitis, peri implantitis, peri-implant mucositis, necrotizing gingivitis, necrotizing periodontitis and caries in a subject, by selectively promoting, in an oral cavity of a subject: 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, the method comprising contacting an oral cavity of the subject with the oral care composition (¶ [0076]). The composition comprises a surfactant (¶ [0098]). The surfactant is at least one selected from sodium lauryl sulfate, cocamidopropyl betaine, and combinations thereof (¶ [0030]).
Stettler differs from the instant claims insofar as not disclosing D-(+)-trehalose or D-(+)-raffinose as the saccharide prebiotic.
However, Sasaki discloses wherein sweeteners (including saccharides) include monosaccharides, disaccharides, oligosaccharides, sugar alcohols and high intensity sweeteners. Disaccharides include trehalose (i.e., D-(+)-trehalose per PubChem reference of record). Oligosaccharides include raffinose (i.e., D-(+) raffinose per PubChem reference of record) (¶ [0126]).
Stettler discloses testing various sugar derivatives to identify substrates that would selectively favor the growth of beneficial bacteria while directly or indirectly suppressing the growth of harmful bacteria. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated D-(+)-trehalose or D-(+)-raffinose as the saccharide prebiotic in order to test their effectiveness since they are known saccharide sugars as taught by Sasaki.
In regards to instant claims 15-18, since the composition of the prior art comprises substantially the same saccharide prebiotic as claimed, the composition of the prior art necessarily has the properties recited in claims 15-18.
In regards to instant claims 19 and 20 reciting wherein the composition is in an amount sufficient to decrease the gene expression of one or more inflammatory biomarker in oral keratinocytes, as noted in the instant specification on page 4, the amount of saccharide prebiotic is about 0.5%, 1% or 2%. Steller discloses the amount of saccharide prebiotic is 0.1% to 5%. As such, since the prior art comprises substantially the same amount of saccharide prebiotic as the claimed invention, the composition of the prior art is in an amount sufficient to decrease the gene expression of one or more inflammatory biomarker in oral keratinocytes.
Response to Arguments
Applicant argues that Sasaki merely disclose trehalose and raffinose as saccharide sweeteners. Not all saccharides exhibit prebiotic activity. Thus, the mere fact that trehalose and raffinose are known saccharides does not mean that one or ordinary skill in the art would expect them to function as prebiotics.
The Examiner does not find Applicant’s argument to be persuasive. Applicant is not considering the teachings of Stettler. Stettler discloses in paragraph [0006] testing a large number of sugar derivatives to identify substrates that would selectively favor the growth of beneficial bacteria while directly or indirectly suppressing the growth of harmful bacteria. Since Stettler tested a large number of sugar derivatives, it is not clear why it would not have been obvious to one of ordinary skill in the art to also test various sugar derivatives, such as trehalose and raffinose. Also, since Stettler tested a number of sugar derivatives to identify substrates that would selectively favor the growth of beneficial bacteria while directly or indirectly suppressing the growth of harmful bacteria, Stettler did not know which of the sugar derivatives would function as prebiotics. Therefore, one of ordinary skill in the art would not need to expect trehalose and raffinose to function as prebiotics in order to test them. As such, Applicant’s argument is unpersuasive.
Applicant argues that mere knowledge that trehalose and raffinose are known saccharides does not establish a reasonable expectation that the saccharides would selectively enhance beneficial oral bacteria while suppressing harmful strains. After evaluating numerous sugar derivatives, Stettler identified only a limited subset that selectively promoted beneficial oral bacteria while inhibiting pathogenic strains. This teaching would lead a skilled person in the art to expect that most saccharides would not necessarily possess the claimed dual activity.
The Examiner does not find Applicant’s argument to be persuasive. As discussed previously, Stettler discloses wherein some saccharides are prebiotic and it would be unreasonable to assume Stettler tested every single known sugar derivative due to the magnitude of sugar derivatives that exists. Therefore, one of ordinary skill in the art would have been motivated to test other saccharides not disclosed by Stettler but are known in the art to see if they are prebiotic. Such selective biological activity may be unpredictable, but there is a reasonable expectation for success since Stettler discloses wherein some saccharides are prebiotic and wherein it is within the skills of one of ordinary skill in the art to test a large number of saccharides. As such, Applicant’s argument is unpersuasive.
Applicant argues that the data in the specification shows that D-(+)-trehalose and D-(+)-raffinose increase the growth of beneficial bacteria and negatively affect the growth of certain pathogenic strains of bacteria (Example 1). This demonstrated selective prebiotic effect of D-(+)-trehalose and D-(+)-raffinose is not taught by Stettler and Sasaki. Therefore, it would not be obvious to modify Stettler’s composition by adding 0.5-1% D-(+)-trehalose or D-(+)-raffinose to arrive at the claimed composition with a reasonable expectation that D-(+)-trehalose or D-(+)-raffinose would provide the dual effect of selectively enhancing beneficial oral bacteria while suppressing harmful strains.
The Examiner does not find Applicant’s argument to be persuasive. As discussed above and in the rejection, it would have been obvious to one of ordinary skill in the art to test trehalose and raffinose to see if they would selectively enhance beneficial oral bacteria while suppressing harmful strains. Since it would have been obvious to have tested trehalose and raffinose, Applicant discovering that trehalose and raffinose can selectively enhance beneficial oral bacteria while suppressing harmful strains is not unexpected. As such, Applicant’s argument is unpersuasive.
Conclusion
Claims 1, 4, 5, 8, 9, 11, 12, 15-23, 35 and 36 are rejected.
No claims are allowed.
THIS ACTION IS MADE FINAL. 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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/TRACY LIU/Primary Examiner, Art Unit 1614
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