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, 2, 4-8, 11-13, 15 and 16.
Applicants' arguments, filed 03/06/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 § 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 4, 6, 11 and 12 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.
1. Claims 4 and 12 recite wherein the composition comprises one or more active compounds and one or more additional compounds. The one or more oral care active compounds are selected from a Markush group, which means that the composition can only comprise actives within the Markush group. The claims are indefinite since it is unclear what active compounds are excluded from the composition since the composition comprises additional compounds, which include active compounds, such as peptides, but are not recited within the Markush group. Peptides are active compounds as disclosed in paragraph [0025] of Doyle et al. (US 2005/0163727).
2. Claim 6 recites wherein the composition comprises an anti-inflammatory agent, a pain reliever, an antioxidant, an enzyme, or a cooling agent. These ingredients are active compounds. Claim 1 limits the active compounds to those recited in the Markush group. Therefore, the claim is indefinite since it is unclear what active compounds are excluded from the composition since the composition comprises active compounds not recited within the Markush group.
3. Claim 11 recites oral care antimicrobial composition comprising an amount of the oral care antimicrobial composition. The claims are indefinite since it is unclear how an oral care antimicrobial composition can comprise an amount of itself.
Response to Arguments
Applicant argues that the Examiner has not identify which of those compounds of claim 6 are active compounds as recited in claim 1.
The Examiner does not find Applicant’s argument to be persuasive. All of the compounds in claim 6 are active compounds. An active compound is a compound that produces a specific physiological effect or health benefit in living organisms. An anti-inflammatory agent, a pain reliever, an antioxidant, an enzyme, and a cooling agent all fit this definition. As such, Applicant’s argument is unpersuasive.
The other rejections are maintained because there are still indefinite even with Applicant’s amendment.
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, 2, 4-8, 11-13 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Doyle et al. (US 2005/0163727, Jul. 28, 2005) (hereinafter Doyle), as evidenced by WHO (Oxanone, 2025).
Doyle discloses an oral composition comprising a safe and effective amount of an antimicrobial agent, which effectively controls bacteria-mediated diseased and conditions present in the oral cavity. The antimicrobial agent may be triclosan (i.e., oral care active compound), chlorhexidine, peptides (i.e., additional compound), and mixtures thereof (¶ [0025]). These agents may be present at levels of at least about 0.01% by weight of the composition (¶ [0056]). The composition is effective in treating diseases of the oral cavity, such as plaque, gingivitis, and periodontal disease. Preferred antimicrobials are those that are effective against S. sanguis (¶ [0046]). The composition may may be in the form of a subgingival gel, which may be aqueous or non-aqueous, and comprise about 0.04% to about 2% of a flavoring agent (¶ [0087]) Suitable flavoring agents include oxanone (¶ [0125]). The composition may comprise from about 0.001% to about 5% of anti-inflammatory agents (i.e., orally acceptable ingredient) (¶ [0133]). The composition is made by mixing the ingredients (¶ [0165]).
As evidenced by WHO, oxanone is synonymous with raspberry ketone.
The prior art discloses a composition comprising oxanone (i.e., raspberry ketone) (¶ [0125]), triclosan (i.e., active compound) (¶ [0025]), peptide (i.e., additional compound (¶ [0025]), and anti-inflammatory agent (i.e., orally acceptable ingredient) (¶ [0133]). 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 claims 11, 13 and 16 reciting about 0.01 wt. to about 15.0 wt. % of the antimicrobial composition, the claimed antimicrobial composition comprises raspberry ketone and triclosan. Doyle discloses about 0.04% to about 2% oxanone (raspberry ketone) and at least about 0.01% triclosan. The combined amount of oxanone and triclosan overlaps with the claimed range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 A. In regards to instant claims 13 and 16 reciting killing or inhibiting the growth of bacteria and fungi in the oral care product and preserving the oral care composition, respectively, because the composition of Doyle comprises antimicrobial agents, it would have been obvious to one of ordinary skill in the art that the composition kills or inhibits the growth of bacteria and fungi within the composition and thus preserves the composition. Also, Doyle discloses in paragraph [0080] wherein the composition may comprise preservatives.
2. Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Doyle et al. (US 2005/0163727, Jul. 28, 2005) (hereinafter Doyle) in view of Brown (US 2007/0190090, Aug. 16, 2007), as evidenced by WHO (Oxanone, 2025).
The teachings of Doyle are discussed above. Doyle does not teach wherein the composition comprises chlorhexidine digluconate as the antimicrobial agent.
However, Brown discloses biofilm-responsive oral care products (abstract). Topical antimicrobials include chlorhexidine digluconate (chlorhexidine) (¶ [0097]).
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. Doyle discloses wherein the composition may comprise chlorhexidine as an antimicrobial agent. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated chlorhexidine digluconate into the composition of Doyle since it is a known and effective chlorhexidine antimicrobial agent for oral care compositions as taught by Brown.
Response to Arguments
Applicant argues that the alleged combination does not fairly teach or suggest the claims at issue.
The Examiner does not find Applicant’s argument to be persuasive. With regards to claims 1 and 12, as discussed in the rejection, Doyle still teaches the claimed active compound and additional compound. As such, Applicant’s argument is unpersuasive.
Conclusion
Claims 1, 2, 4-8, 11-13, 15 and 16 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.
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/TRACY LIU/Primary Examiner, Art Unit 1614