DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions. Claims included in the prosecution are claims 1-18.
Applicants' arguments, filed 07/23/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 and 4-18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Schick et al. (US 2007/0140992, Jun. 21, 2007) (hereinafter Schick) in view of Douglas (US 2009/0215727, Aug. 27, 2009).
Schick discloses an oral care composition comprising (a) an effective amount of a hydrocolloid selected from alginate (i.e., claimed chelator) or alginic acid derivative, pectin or pectin derivative (i.e., claimed chelator), and mixtures thereof; and (b) about 0.01 weight % to about 5 weight % of essential oils (claim 13). Pectin or pectin derivatives can be present at from about 0.05% to about 5% (¶ [0021]). The composition may additionally comprise flavors. Suitable flavors include mint, citrus, and/or cinnamon (i.e., claimed enhancer). The flavors will be used in amounts from about 0.05 to about 1.0 % (¶ [0033]). Buffering systems may be used to stabilize the pH in the product. Typical buffering systems include phosphate (i.e., claimed another base) (¶ [0035]). The composition may be in the form of a toothpaste, mouthwash, gel, edible film, chewing gum, tablet, or capsule (i.e., meeting direct oral application) (claim 12). Anticalculus agents can be optionally added to the composition (¶ [0032]).
Schick differs from the instant claims insofar as not disclosing wherein the composition comprises pyridoxal-5-phosphate (i.e., claimed base).
However, Douglas discloses treating periodontal disease in a patient in need thereof by administering pyridoxal-5-phosphate (claim 16). The therapeutically effective amount of pyriodoxal-5-phosphate is about 0.5 to about 50 mg/kg body weight (claim 24).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated pyridoxal-5-phoshate into the composition of Schick motivated by the desire to formulate the composition to treat periodontal disease as taught by Douglas.
In regards to instant claim 1 reciting an anti-biofilm composition, this is merely a recitation of the intended use of the claimed composition. Since the composition Schick comprises anti-calculus agents, the composition of Schick would be usable as an anti-biofilm composition whether the prior art discloses such use or not.
In regards to instant claim 1 reciting wherein the chelator and base provide microbial affecting activity, the pectin and pyridoxal-5-phosphate of the prior art appears to be substantially the same chelator and base as claimed, respectively. Thus, one of ordinary skill in the art would reasonably expect that the pectin and pyridoxal-5-phosphate of the prior art provides microbial affecting activity like the claimed invention's pectin and pyridoxal-5-phosphate.
In regards to instant claim 5 reciting about 50 ng to about 1,000 mg chelator, Schick discloses about 0.05 to about 5% pectin. Thus, assuming a 100 g composition comprising 0.5% pectin, it would have been obvious to have a composition comprising 500 mg cyclodextrin.
In regards to instant claim 9 reciting about 50 ng to about 1,000 mg base, Douglas discloses wherein a therapeutic amount of pyridoxal-5-phosphate is about 0.5-50 mg/kg per day. Thus, assuming 0.5 mg/kg is administered to a 150 pound individual, it would have been obvious to have a composition comprising 34.02 mg pyridoxal-5-phosphate.
In regards to instant claim 15 reciting wherein the composition is formulated for administration at least once per day, Schick discloses wherein the composition may be in the form of a toothpaste. Therefore, it would have been obvious to one of ordinary skill in the art that the composition is formulated for administration at least once per day since toothpastes are used at least once per day.
In regards to instant claim 16 reciting wherein the composition is used to promote oral health, since the composition of the prior art comprises pyridoxal-5-phosphate, which treats periodontal disease, it would have been obvious to one of ordinary skill in the art that the composition of the prior art promotes oral health.
In regards to instant claims 17 and 18 reciting wherein the composition is for use following consumption of a phosphoric acid or ascorbic acid containing beverage and for use following consumption of food, respectively, this is merely a recitation of the intended use of the claimed composition. The composition of the prior art may be a toothpaste, which may be used at any time, and thus would be usable following consumption of a phosphoric acid or ascorbic acid containing beverage or consumption of food, whether the prior art recognizes such use or not.
Response to Arguments
Applicant argues that Douglas does not teach the use of P5P to fight microbes.
The Examiner does not find Applicant’s argument to be persuasive. 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). Thus, although Applicant incorporates P5P into the claimed composition to fight microbes, it is not necessary for the prior art to disclose incorporating P5P for the same reason. Furthermore, although instant claim 1 recites wherein the base provide microbial affecting activity, the pyridoxal-5-phosphate of the prior art appears to be substantially the same base as claimed. Thus, one of ordinary skill in the art would reasonably expect that the pyridoxal-5-phosphate of the prior art provides microbial affecting activity like the claimed invention's pyridoxal-5-phosphate, whether the prior art discloses such use or not. As such, Applicant’s argument is unpersuasive.
Applicant argues that all of the teachings of Douglas would be directed to providing relief to inflamed gums and not towards antimicrobial or anti-biofilm activity.
The Examiner does not find Applicant’s argument to be persuasive. As discussed above, it is not necessary for the prior art to disclose incorporating P5P for the same reason as Applicant. As such, Applicant’s argument is unpersuasive.
Applicant argues that Douglas teaches the use of a P5P primarily as an injectable therapeutic or oil. It is not a direct oral application.
The Examiner does not find Applicant’s argument to be persuasive. Douglas discloses in paragraph [0061] wherein P5P can be administered orally. Douglas further discloses in paragraph [0059] wherein P5P can be administered in a solution. Douglas discloses in paragraph [0060] that the specific dosage form is not limited. As such, Douglas does not require P5P to be injectable or to be administered by a pill. Because Douglas discloses wherein P5P may be administered orally and wherein the composition may be a solution, it would have been obvious to one of ordinary skill in the art that P5P is suitable for direct oral application like a mouthwash. As such, Applicant’s argument is unpersuasive.
2. Claim 3 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Schick et al. (US 2007/0140992, Jun. 21, 2007) (hereinafter Schick) in view of Douglas (US 2009/0215727, Aug. 27, 2009), and further in view of Joiner et al. (US 2013/0302393, Nov. 14, 2013) (hereinafter Joiner).
The teachings of Schick and Douglas are discussed above. Schick and Douglas do not disclose wherein the composition comprises amidated pectin.
However, Joiner discloses an oral care composition (abstract). The composition may comprise low-methyl ester pectins. Such material may be amidated (¶ [0041]).
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. Schick discloses wherein the composition may comprise pectin derivatives. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated low-methyl ester pectins, which may be amidated, into the composition of Schick since they are known and effective pectin derivatives for oral care compositions as taught by Joiner.
Response to Arguments
Applicant argues that Joiner does not cure the deficiencies of Schick and Douglas.
The Examiner submits that arguments regarding Schick and Douglas have been addressed above and are unpersuasive. Therefore, this rejection is maintained.
Conclusion
Claims 1-18 are rejected.
Claims 19-26 have been withdrawn.
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.
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
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