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, 7, 8, 12, 13, 15 and 16.
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/30/2026 has been entered.
Applicants' arguments, filed 06/30/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 1, 2, 4, 7, 8, 12, 13, 15 and 16 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. Claim 4 recite wherein the composition comprises one or more active compounds and further 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 further comprises 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).
Response to Arguments
Rejection is maintained since removing the phrase “one or more additional” does not address the indefiniteness issue.
2. Claim 1 recite wherein the composition comprises one or more active compounds and an orally acceptable ingredient. 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 claim is indefinite since it is unclear what active compounds are excluded from the composition since the composition further comprises an orally acceptable ingredient, which includes active compounds, such as anti-inflammatory agent, but are not recited within the Markush group.
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, 7, 8, 12, 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. mutans (¶ [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 1, 12, and 13 reciting killing or inhibiting growth of Streptococcus mutans, this is merely a recitation of the intended use of the claimed composition. As noted in paragraph [0021] of the instant specification, mixing components (a), (b) and (c) kills or inhibits the growth of Streptococcus mutans. Thus, since the composition of Doyle comprises oxanone (i.e., raspberry ketone) (component (a)), triclosan (component (b)), and peptide (component (c)), the composition is capable of killing or inhibiting the growth of Streptococcus mutans, whether the prior art discloses such use or not.
In regards to instant claim 13 reciting an oral care product susceptible to growth of microorganisms, Doyle discloses in paragraph [0046] wherein the composition is effective in killing microorganisms which cause topically-treatable infections and diseases of the oral cavity. Thus, the composition of Doyle is susceptible to growth of microorganisms.
In regards to instant claims 13 and 16 reciting about 0.01 wt. to about 15.0 wt. % of the antimicrobial composition, the antimicrobial composition of instant claim 1 comprises raspberry ketone, triclosan, and anti-inflammatory agent. Doyle discloses about 0.04% to about 2% oxanone (raspberry ketone), at least about 0.01% triclosan, and about 0.001% to about 5% of anti-inflammatory agents. The combined amount of oxanone triclosan, and anti-inflammatory 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 claim 16 reciting preserving a composition, 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 within the composition and thus preserves the composition from bacterial growth. Also, Doyle discloses in paragraph [0080] wherein the composition may comprise preservatives.
Response to Arguments
Applicant argues that there is no motivation to re-target Doyle’s periodontal compositions to Streptococcus mutans and further modify the compositions to achieve the specifically claimed antimicrobial effect against Streptococcus mutans.
The Examiner does not find Applicant’s argument to be persuasive. Doyle discloses in paragraph [0046] wherein the antimicrobials are effective against S. mutans. Thus, the composition of Doyle does have an antimicrobial effect against Streptococcus mutans and Applicant’s argument is unpersuasive.
Applicant argues that Doyle’s disclosure of oxanone is expressly in the context of a flavoring agent, whereas Doyle’s antimicrobial teaching is directed to treating bacteria-mediated conditions in the oral cavity.
The Examiner does not find Applicant’s argument to be persuasive. Applicant’s recitation of killing or inhibiting growth of S. mutans is merely a recitation of intended use. As noted in paragraph [0021] of the instant specification, mixing components (a), (b) and (c) kills or inhibits the growth of Streptococcus mutans. Thus, since the composition of Doyle comprises oxanone (i.e., raspberry ketone) (component (a)), triclosan (component (b)), and peptide (component (c)), the composition is capable of killing or inhibiting the growth of Streptococcus mutans, whether the prior art discloses such use or not. Doyle disclosing wherein oxanone is a flavoring agent does not affect the composition from comprising oxanone and making the composition capable of killing or inhibiting the growth of Streptococcus mutans. As such, Applicant’s argument is unpersuasive.
Applicant argues that Doyle’s primary teaching is directed to antimicrobial activity in the oral cavity, not preservation of the product during storage.
The Examiner does not find Applicant’s argument to be persuasive. Claim 16’s recitation of preserving a composition is merely a recitation of intended use. 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 within the composition and thus preserves the composition from bacterial growth. Applicant has not shown wherein the composition of Doyle is incapable of being preserved. As such, Applicant’s argument is unpersuasive.
Applicant argues that Doyle’s statement that preservatives may be included does not teach or suggest nor does it provide a reasoned basis to equate therapeutic antimicrobial use with the claimed in-product preservation objectives.
The Examiner does not find Applicant’s argument to be persuasive. Claim 16 recites a method of preserving a composition. An antimicrobial composition comprising a preservative would necessarily form a preserved composition, which meets the claim limitation of preserving a composition. As such, Applicant’s argument is unpersuasive.
Applicant argues that Doyle and the present subject matter are not merely directed to different bacteria, they are directed to microorganisms with fundamentally different roles in the oral microbiome.
The Examiner does not find Applicant’s argument to be persuasive. As discussed above. Doyle does teach Streptococcus mutans. As such, Applicant’s argument is unpersuasive.
Applicant argues that the present subject matter demonstrates a specific and unexpected antimicrobial effect against Streptococcus mutans, as evidenced by Table 1.
The Examiner does not find Applicant’s argument to be persuasive. It is not clear how Table 1 shows unexpected results. Applicant has not made any comparisons with a single antimicrobial compound. Also, even if Applicant did make such a comparison, Applicant has not shown wherein the result would be through synergy and not an additive effect. As such, Applicant’s argument is unpersuasive.
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 rejection does not explain why a person of ordinary skill would have selected the specific salt form from Brown for use in Doyle’s formulations.
The Examiner does not find Applicant’s argument to be persuasive. As discussed in the rejection, 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. Such rationale is proper since 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. Applicant has not shown wherein the inclusion would not be suitable. As such, Applicant’s argument is unpersuasive.
Applicant argues that Brown does not suggest combing chlorhexidine with raspberry ketone for antimicrobial enhancement.
The Examiner does not find Applicant’s argument to be persuasive. As this is a 103 obviousness rejection, no one piece of prior art is required to teach each and every claim limitation. Therefore, it is not necessary for Brown to teach raspberry ketone. Also, 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). As such, Applicant’s argument is unpersuasive.
Applicant argues that Doyle does not attribute any antimicrobial effect to raspberry ketone.
The Examiner does not find Applicant’s argument to be persuasive. The instant claims do not require the antimicrobial effect to be from raspberry ketone. The instant claims recite wherein the oral care antimicrobial composition is used for killing or inhibiting growth of S. mutans. As such, Applicant’s argument is unpersuasive.
Applicant argues that neither reference addresses cariogenic bacteria (S. mutans).
The Examiner does not find Applicant’s argument to be persuasive. As discussed above, Doyle does teach S. mutans. As such, Applicant’s argument is unpersuasive.
Conclusion
Claims 1, 2, 4, 7, 8, 12, 13, 15 and 16 are rejected.
No claims are allowed.
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/TRACY LIU/Primary Examiner, Art Unit 1614
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