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 .
Applicants' arguments, filed December 31, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims
Claim Rejections - 35 USC § 112 – Indefiniteness (New Rejection)
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 1-13, 16-17 and 19 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. Claim 1 recites “an antioxidant selected from ascorbyl phosphate, ascorbate, butylated hydroxytoluene (BHT), and butylated hydroxyanisole (BHA)“, then further recites “the mouthwash having a molar ratio of the ascorbyl phosphate to the stannous ion source of 0.05 to 0.1”. It is not clear if the ascorbyl phosphate is required by the instant claim since is a part of a group. Further, it is not clear if the ratio is the ratio range or the actual ratio.
Claim Rejections - 35 USC § 103 – Obviousness (Modified Rejection)
Claims 1-13, 16-17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over North et al. (US 2022125786).
North et al. disclose oral care compositions comprising ascorbic acid derivatives. The oral care composition comprises an ascorbic acid derivative, includes (+) sodium L-ascorbate, and sodium ascorbyl phosphate (paragraph 0007). The ascorbyl phosphate comprises 0.5% by weight to 5% by weight of the total composition (paragraph 0027). The oral care composition of the disclosure is in a form selected from a toothpaste, a dentifrice, a mouthwash, a mouthrinse, a topical oral gel and a denture cleanser (paragraph 0008). The composition further comprises a stannous ion source (paragraph 0057). Stannous ion sources include stannous fluoride, stannous chloride and organic stannous carboxylate salts (paragraph 0076). The stannous ion source comprises 0.1 wt.% to 2 wt.% of the total composition (paragraph 00108, section 1.6). The oral care compositions may comprise at least one stain prevention agent in addition to an ascorbic acid derivative and includes tetrasodium pyrophosphate (TSPP), disodium pyrophosphate (SAPP), sodium tripolyphosphate (STPP), sodium hexametaphosphate (SHMP), or zinc citrate (paragraph 0059). They comprises 0.1 to about 60% by weight of the composition (paragraph 0060) also 0.5 to 5% by weight (paragraph 00108, section 1.40-1.42). The oral care composition may comprise at least one zinc ion source. Zinc ions may act as anti-malodor agents and include zinc oxide, zinc citrate, and/or combinations thereof (paragraph 0077). The oral care composition may comprise at least one antioxidant agent. The antioxidant agent includes butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), and, ascorbic acid (paragraph 0071). The oral care composition may comprise at least one erosion prevention agent including sodium fluoride, arginine, arginine phosphate, arginine hydrochloride, arginine bicarbonate, zinc oxide, zinc citrate and zinc citrate trihydrate). Optionally the composition comprises water (paragraph 0009). Mouthwashes comprise water (paragraphs 0016-0017). The terms “mouthwash” or "mouthrinse" refer to oral care compositions that are substantially liquid in character, such as a spray, or rinse. In such a preparation, the oral care composition typically has an aqueous phase comprising water or a water and alcohol mixture. Generally, the weight ratio of water to alcohol is in is most preferably 4:1 to 6:1. The total amount of water and alcohol mixture in this type of preparation is typically in an amount from 70% by weight to 99.9% by weight of the preparation. The erosion prevention agent or combinations thereof may be present in the oral care composition in an amount ranging from about 0.2 % by weight to about 10.0% by weight (paragraph 0072). The pH of the compositions range from 5 to 11 (paragraph 00120). A composition comprises zinc phosphate, 1 to 5% sodium ascorbyl phosphate, 0.1 to 2% stannous fluoride and arginine. This composition may comprise other oral care components.
North et al. is not anticipatory insofar as it they do not specifically disclose an example comprising sodium ascorbyl phosphate in combination with a stannous compound and tetrasodium pyrophosphate. 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. Therefore, it would have been obvious to one of ordinary skill in the art to have added tetrasodium pyrophosphate to one of the examples comprising ascorbyl phosphate and stannous fluoride because the combination is suggested by North et al.
In regards to the amounts, the ascorbate derivative may comprise 0.5% by weight to 5% by weight of a composition. The stannous may comprise 0.1 wt.% to 2 wt.% and tetrasodium pyrophosphate may comprises 0.05 to about 5% by weight. These ranges overlap those recited by the instant claims. Therefore the ratios encompassed by North et al. overlap those of the instant claims. It is well-settled, that even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05. Accordingly, since an overlap plainly exists here, it would have been obvious to have selected values within the overlap.
In regards to claim 19, generally, the weight ratio of water to alcohol is in is most preferably 4:1 to 6:1. The total amount of water and alcohol mixture in this type of preparation is typically in an amount from 70% by weight to 99.9% by weight of the preparation. When the ratio is 6:1 at 70%, the amount of water would be 60% meeting instant claim 19.
Response to Arguments
The Examiner submits that North discloses mouthwash compositions meeting the limitation of a mouthwash of the amended claims. In regards to the molar ratio, in regards to claim 1, it is not clear if 0.05 to 0.1 is the actual ratio or the ratio range. It is further noted that claim 5 has a stannous ion source to tetrasodium pyrophosphate to antioxidant ratio of 1:0.5-1.5:0.05-0.1, which does not appear to be encompassed by the ratio in claim 1 when the antioxidant is ascorbyl phosphate (see Indefiniteness rejection). In regards to the ratios, when looking to the instant specification for guidance, the amount used in the examples fall within the range of that disclosed by North. Therefore one would reasonably conclude that the ranges encompassed by North either encompass or overlap that of the instant claims. In regards to the improper reconstruction of the claims, North discloses a combination of ascorbyl phosphate, stannous fluoride and zinc salt. North further discloses tetrasodium pyrophosphate may be added to the compositions in an amount ranging from about 1-2% (section 1.6). Therefore, it would have been obvious to have added tetrasodium pyrophosphate in an amount from 1-2 (which encompasses the amount in the examples of the instant specification) to the examples of North because it is suggested. Accordingly, since the amounts disclosed by North encompass/overlap that disclosed and recited by the instant specification/claims, one of ordinary skill in the art would reasonably conclude that North also encompass and overlap the molar ratios of the instant claims. It is further noted that in Table 1 a ratio is disclosed for SnF2:TSPP:antioxidant of 1:1:0.3. In this case, the amount of sodium ascorbyl phosphate was 1.2425 g and stannous fluoride is 2.0037 g. Sodium ascorbyl phosphate may be used in an amount from about 0.5% to 5% (paragraph 0027) (which would encompass 1.24%) and stannous fluoride may be used in an amount of 2% in the compositions of North. One would reasonably conclude that the percentages would encompass substantially the same ratio as grams. Therefore when the ratio is 1:1:0.1, it would appear sodium ascorbyl would be in an amount of about 0.41 g (about 0.5). A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05, I. Therefore the amounts are close enough where one of ordinary skill would conclude that they would exhibit substantially the same properties. See MPEP 2144.05, I.
In regards to new claim 19, as stated above the total amount of water and alcohol mixture in this type of preparation is typically in an amount from 70% by weight to 99.9% by weight of the preparation. When the ratio is 6:1 at 70%, the amount of water would be 60% meeting instant claim 19.
Conclusion
Claims 1-13, 16-17 and 19 are rejected.
No claims 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 LEZAH ROBERTS whose telephone number is (571)272-1071. The examiner can normally be reached Monday-Friday 11:00-7:30.
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/LEZAH ROBERTS/Primary Examiner, Art Unit 1612
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