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, 30-34 and 38-40.
Response to Arguments
In view of the Appeal Brief filed on 07/27/2026, PROSECUTION IS HEREBY REOPENED. New grounds of rejection are set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/ALI SOROUSH/ Supervisory Patent Examiner, Art Unit 1614
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.
1. Claims 1, 31-34 and 38-40 are rejected under 35 U.S.C. 103 as being unpatentable over Boyd et al. (US 2004/0136924, Jul. 15, 2004) (hereinafter Boyd) in view of Tutuncu et al. (US 2003/0118628, Jun 26, 2003) (hereinafter Tutuncu).
Boyd discloses a composition comprising a film or a plurality of film fragments entrained in a carrier. The film or plurality of film fragments can comprise a functional material (abstract). The composition may be a dentifrice, mouthwash, dental gel, liquid toothpaste, or spray. The composition may be used for gingivitis prevention or reduction (¶ [0088]). Suitable functional materials include cooling agents, anti-caries agents, tartar control actives, probiotics, and combinations thereof (¶ [0065]). Suitable anti-caries agents include stannous fluoride (¶ [0071]). Suitable tartar control agents include sodium hexametaphosphate (¶ [0068]). The film may also comprise tooth desensitizers such as potassium nitrate (¶ [0071]).
Boyd differs from the instant claims insofar as not disclosing wherein the composition comprises monomethyl succinate.
However, Tutuncu discloses a confectionery product (abstract). A cooling compound is added to the salivation region of the product to enhance salivation (¶ [0022]). Suitable cooling compounds include monomethyl succinate (¶ [0031]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Boyd discloses wherein the composition comprises cooling agents. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated monomethyl succinate into the composition of Boyd since it is a known and effective cooling agent as taught by Tutuncu.
Regarding instant claim 1 reciting wherein the composition is effective for (a) selectively promoting growth, metabolic activity or colonization of S. mitis bacteria that have beneficial effects on oral health, relative to growth metabolic activity or colonization of pathogenic oral bacterial; (b) selectively promoting biofilm formation by S. mitis bacteria that have beneficial effects on oral health, relative to biofilm formation by pathogenic oral bacteria; or (c) maintaining and/or re-establishing a healthy oral microbiota comprising S. mitis, the composition of the prior art comprises substantially the same active agent (i.e. monomethyl succinate) as the claimed invention. Therefore, one of ordinary skill in the art would reasonably expect that the composition of the prior art is effective for (a) selectively promoting growth, metabolic activity or colonization of S. mitis bacteria that have beneficial effects on oral health, relative to growth metabolic activity or colonization of pathogenic oral bacterial; (b) selectively promoting biofilm formation by S. mitis bacteria that have beneficial effects on oral health, relative to biofilm formation by pathogenic oral bacteria; or (c) maintaining and/or re-establishing a healthy oral microbiota comprising S. mitis like the claimed invention.
Regarding instant claims 32-34 reciting a method of selectively promoting 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 or selectively promoting biofilm formation by bacteria that have beneficial effects on oral health, relative to biofilm formation by pathogenic oral bacteria; a method of maintaining and/or re-establishing a healthy oral microbiota; and a method of preventing one or more of gingivitis, periodontitis, peri-implantitis, peri-implant mucositis, necrotizing gingivitis, necrotizing periodontitis and caries; the composition of the prior art comprises substantially the same monomethyl succinate as the claimed invention. Therefore, one of ordinary skill in the art would reasonably expect the composition of the prior art to selectively promote growth, metabolic activity or colonization of bacteria that have beneficial effects on oral health, relative to growth metabolic activity or colonization of pathogenic oral bacterial or selectively promote biofilm formation by bacteria that have beneficial effects on oral health, relative to biofilm formation by pathogenic oral bacteria; maintain and/or re-establish a healthy oral microbiota; and prevent one or more of gingivitis, periodontitis, peri-implantitis, peri-implant mucositis, necrotizing gingivitis, necrotizing periodontitis and caries like the claimed invention when applied to an oral cavity of a subject.
2. Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Boyd et al. (US 2004/0136924, Jul. 15, 2004) (hereinafter Boyd) in view of Tutuncu et al. (US 2003/0118628, Jun 26, 2003) (hereinafter Tutuncu), and further in view of Wikström et al. (US 2009/0324547, Dec. 31, 2009) (hereinafter Wikström).
The teachings of Boyd and Tutuncu are discussed above. Boyd and Tutuncu do not teach wherein the composition comprises Streptococcus mitis.
However, Wikström discloses an oral composition comprising a combination of probiotic bacteria such as Streptococcus and pH-rising and/or buffering components, which re-establishes an oral microflora associated with good oral health in subjects with a disturbed oral microflora (abstract). Suitable Streptococcus bacteria include Streptococcus mitis (claim 1).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated Streptococcus mitis and pH-rising and/or buffering components into the composition of Kulke motivated by the desire to establish an oral microflora associated with good oral health when using the composition as taught by Wikström. One of ordinary skill in the art would have had a reasonable expectation of success since Boyd discloses wherein the composition comprises probiotics.
Conclusion
Claims 1, 30-34 and 38-40 are rejected.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRACY LIU whose telephone number is (571)270-5115. The examiner can normally be reached Mon-Fri 9 am - 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TRACY LIU/Primary Examiner, Art Unit 1614
Prosecution Insights