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.
Applicants' arguments, filed 02/05/2025, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
1. Claims 1, 31-34 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Kulke et al. (US 2015/0313820, Filing date: Dec. 12, 2012) (hereinafter Kulke).
Kulke discloses preparations comprising menthol compounds (abstract). Suitable menthol compounds include monomethyl succinate (claim 2). The preparation may be in the form of a toothpaste comprising sodium fluoride (Table 6a).
The prior art discloses a toothpaste (Table 6a) comprising monomethyl succinate (claim 2). Together these would provide a composition as claimed instantly. The prior art is not anticipatory insofar as these combinations must be selected from various lists/locations in the reference. It would have been obvious, however, to make the combination since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP 2143(I)(A).
In regards to 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 Kulke 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 Kulke 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.
In regards to instant claim 31 reciting wherein the composition is for use in preventing one or more of gingivitis, periodontitis, peri-implantitis, peri-implant mucositis, necrotizing gingivitis, necrotizing periodontitis and caries, this is merely a recitation of the intended use. The composition of the prior art, insofar as can be determined, comprises substantially the same monomethyl succinate as the claimed invention and thus would be useable in preventing one or more of gingivitis, periodontitis, peri-implantitis, peri-implant mucositis, necrotizing gingivitis, necrotizing periodontitis and caries, whether the prior art recognizes such use or not.
In regards to 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 Kulke comprises substantially the same monomethyl succinate as the claimed invention. Therefore, one of ordinary skill in the art would reasonably expect the composition of Kulke 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 Kulke et al. (US 2015/0313820, Filing date: Dec. 12, 2012) (hereinafter Kulke) in view of Wikström et al. (US 2009/0324547, Dec. 31, 2009) (hereinafter Wikström).
The teachings of Kulke are discussed above. Kulke does 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.
3. Claims 38 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Kulke et al. (US 2015/0313820, Filing date: Dec. 12, 2012) (hereinafter Kulke) in view of Shastry et al. (US 2005/0210615, Sep. 29, 2005) (hereinafter Shastry).
The teachings of Kulke are discussed above. Kulke does not teach wherein the composition comprises potassium nitrate (i.e., claimed antisensitivity agent) and polyaminopropanesulfonic acid.
However, Shastry discloses a composition comprising an oral care active (abstract). The composition can be a toothpaste (¶ [0063]). Suitable oral care actives include anticalculus agents and desensitizing agents (¶ [0065]). Suitable anticalculus agents include polyaminopropanesulfonic acid (¶ [0085]). Suitable desensitizing agents include potassium nitrate (¶ [0094]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated potassium nitrate (i.e., claimed antisensitivity agent) and polyaminopropanesulfonic acid into the composition of Kulke motivated by the desire to have the composition treat sensitivity and tartar, respectively, as taught by Shastry,
Response to Arguments
Applicant’s arguments have been considered but are moot because new rejections necessitated by Applicant’s amendment have been made.
Conclusion
Claims 1, 30-34 and 38-40 are rejected.
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, 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 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.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TRACY LIU/Primary Examiner, Art Unit 1614