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 February 5, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 – New Matter (New Rejection)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3, 5 and 7-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Although the instant specification discloses 62.85 to 77.13, this does not support the full range of “at least” 14.28, which encompasses higher amounts. Therefore it appears the limitations are New Matter.
Claim Rejections - 35 USC § 103 – Obviousness (Maintained Rejections)
1) Claims 1, 3, 5 and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Masters et al. (WO 2009/140577).
Masters et al. disclose oral compositions that may be toothpastes. The compositions comprise a fluoride ion source such as amine fluoride (paragraph 0029). Abrasives include silica and ranges from 1 to 75% (paragraph 0021). Surfactants include cocoamidopropyl betaine and comprise 0.1 to 3% by weight of the composition (paragraph 0031-0032). The compositions may also comprise amino acids such as arginine (paragraph 0040) and zinc salts (paragraph 0041). The compositions have a PCR value ranging from 80-105 (paragraph 0022). Example 3 comprises 22.8% silica, sodium lauryl sulfate, 0.4% cocoamidopropyl betaine and 0.2% sodium fluoride.
Although Masters et al. does not disclose a specific example comprising all the components of the instant claims, it does teach that these components may be used in the compositions disclosed therein and therefore suggests using these components together. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness See MPEP 2144.07. Therefore, it would have been obvious to one of ordinary skill in the art prior to the filing of the instant application to have combined an amine fluoride as the fluoride source, cocoamidopropyl betaine without an anionic surfactant as the surfactant, and a silica abrasive as the abrasive in a composition of Masters et al. because they are suitable for use and because they are suggested by Masters et al.
In order to rely on equivalence as a rationale supporting an obviousness rejection, the equivalency must be recognized in the prior art, and cannot be based on applicant’s disclosure or the mere fact that the components at issue are functional or mechanical equivalents. See MPEP 2144.06, II. It would also have been obvious to have used amine fluoride in place of sodium fluoride and have used cocoamidopropyl betaine alone in the compositions of EXAMPLE 3 because they are taught as equivalents to sodium fluoride and sodium lauryl sulfate, respectively.
Response to Arguments
The Examiner submits that Masters discloses all the components recited by the instant claims and suggests using these components together. Masters discloses using cocoamidopropyl betaine specifically and uses it in an example. One of ordinary skill in the art would reasonably conclude that amounts of cocoamidopropyl betaine encompassed by Masters would meet the limitation of the amended claims, having at least about 14 PCR points higher than 0.57%, because they may be used in higher amounts such as 1.1 to 1.5%. In regards to the motivation, the compositions of Masters comprise cocoamidopropyl betaine. It appears that the PCR is dependent on the cocoamidopropyl betaine. Therefore, a composition comprising above 1.1%, which is encompassed by the range of Masters, would meet the limitation of “at least 14 PCR points”. Further, Masters teaches a range of cocoamidopropyl betaine of 0.1 to 3%, therefore the higher range and the amounts recited in the instant claims are contemplated in Masters and would meet the PCR points limitation. Although Masters does not explicitly disclose this function, one would reasonably expect PCR points would increase due to the increase in cocoamidopropyl betaine because surfactants have a detergent action that also breaks up dental plaque and loosens any sticky food particles that are attached to the teeth (as evidenced by Royal Dental Care, 2022). Therefore impermissible hindsight was not used. In regards to the range achieving unexpected results, it would not appear that the results are unexpected because it appears surfactants are disclosed to affect PCR by their cleaning function. Therefore increasing the amount would increase the PCR value. In regards to the amount of betaine used, the reference is relied on for all it encompasses. See MPEP 2123. Masters discloses betaines may be used in higher amounts. Therefore, one of ordinary skill in the art would be motivated to use higher amounts of betaine because it is suggested by Masters. As stated above, in regards to Applicant increasing the betaine, Master discloses higher amounts. Royal Dental Care discloses surfactants breaks up dental plaque and loosens sticky food particles. One would reasonably conclude that this would in turn indirectly increase PCR. Therefore one would reasonably conclude that PCR would increase with only raising the amount of surfactant.
2) Claims 1, 3, 5, 7 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Brunella et al. (WO 2017/116444).
Brunella et al. disclose dentifrice compositions that may be toothpastes. The compositions comprise a fluoride ion source such as amine fluoride (paragraph 0007). The amine fluoride is an organic fluoride and comprises 0.05% to 3% by weight of the composition. The amine fluoride used is N,N,N’-tris(2-hydroxyethyl)-N’-octadecyl-1,3-diaminopropate dihydrofluoride (Olaflur) (paragraph 0034). Abrasives include hydrated silica abrasives (paragraph 0008). The hydrated silica comprises 5 to 30% by weight (Table 1). Foaming agents used include cocoamidopropyl betaine and comprise 0.01 to about 3% by weight of the composition (paragraph 0045). The compositions may also comprise zinc. Table 1 comprises a composition and the range of each component. The compositions may comprise 25-35% water, 0.05 to 3% amine fluoride, 5-30% hydrated silica and 0.5 to 5% cocoamidopropyl betaine (Table 1). An example comprises 1.84% amine fluoride, 15.5% hydrated silica, 2% cocoamidopropyl betaine and no anionic surfactant (Table 2).
In regard to the pellicle cleaning ratio (PCR), the compositions comprise a combination of amine fluoride, cocoamidopropyl betaine and silica in the amount recited by the instant claims. Therefore, compositions of Brunella et al. would have the same PCR as that of the instant claims because the composition of Hinrichs comprises the combination recited by the instant claims.
Brunella et al. disclose dentifrice compositions that may be toothpastes comprising amine fluoride, silica and cocoamidopropyl betaine; and are discussed above.
Brunella et al. differ from the instant claim insofar as they do not exemplify a composition comprising zinc.
The selection of a known material based on its suitability for its intended use supported a prima facie obviousness See MPEP 2144.07. Therefore, it would have been obvious to one of ordinary skill in the art prior to the filing of the instant application to have added zinc to a composition of Hinrichs et al. because it is suitable for use as a neutralizing agent and because it is suggested by Brunella et al.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. The amounts disclosed in Brunella et al. overlap those of the instant claims. Therefore, the claims are obvious over Brunella et al.
Response to Arguments
The Examiner submits that Brunella discloses all the components recited by the instant claims and suggests using these components together. Brunella discloses using cocoamidopropyl betaine specifically and uses it in an example. One of ordinary skill in the art would reasonably conclude that the amount used in Brunella would meet the limitation of the amended claims, having at least 14 PCR higher than 0.57% because the composition comprises 2% betaine surfactant, which is more than 1.1%. In regards to the motivation, the compositions of Brunella comprise cocoamidopropyl betaine. Therefore one of ordinary skill in the art would be motivated to use betaine in the amounts, which includes 1.1%, disclosed therein. Further, Brunella teaches a range of cocoamidopropyl betaine of 0.5 to 5%. It appears that the PCR is affected by the amount cocoamidopropyl betaine. Therefore the higher range and the amounts recited in the instant claims are contemplated in Brunella and would meet the PCR points limitation. One would reasonably expect the PCR points would increase due to the increase in cocoamidopropyl betaine because surfactants have a detergent action that also breaks up dental plaque and loosens any sticky food particles that are attached to the teeth (as evidenced by Royal Dental Care, 2022). Therefore impermissible hindsight was not used. In regards to a reasonable expectation of success, one would expect an increase in PCR points with the addition of more surfactant because surfactants also breaks up dental plaque and loosens any sticky food particles that are attached to the teeth. Therefore, one would expect an increase in the pellicle cleaning ratio.
In regards to the alleged unexpected results, as stated above surfactants have a detergent action that also breaks up dental plaque and loosens any sticky food particles that are attached to the teeth (as evidenced by Royal Dental Care, 2022). One would reasonably conclude that the amount of betaine surfactant would indirectly affect the PCR. Further, Brunella discloses higher amounts of betaine in their example. Applicant does not appear to show that 2% would not give the same or even better results for the PCR. The motivation to change the amount of betaine is found in the references themselves. Each reference discloses a range that encompasses the range of the instant claims. Therefore one would be motivated to vary the amounts of betaine because surfactants affect cleaning. Therefore, impermissible hindsight was not use.
Conclusion
Claims 1, 3, 5 and 7-10 are rejected.
Claims 13-14 are withdrawn.
No claims 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 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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