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 October 20, 2025, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 § 103 – Obviousness (Maintained Rejections)
1) Claims 1-4, 6, 8-13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Nakatsu et al. (US 2003/0215532) in view of Oertling et al. (US 9,446,267).
Nakatsu et al. disclose new sensate compositions comprising at least one cooling sensate, warming, sensate and tingling sensate. The cooling sensate includes menthol and 3-(1-methoxy)propane-1,2-diol. The warming agent includes vanillyl butyl ether (paragraph 0022). The compositions include mouthwashes meeting dentifrice. The vanillyl butyl ether is present in the composition from {fraction (1/200)} to 1 times the amount of the cooling agent on a weight basis (paragraph 0024). The sensate composition comprises 0.001 to 20% of the final product. Products include personal care products such as toothpaste and mouthwashes (Examples). An example includes a combination of 0.5% menthol, 0.50 3-(1-methoxy)propane-1,2-diol and 0.05% vanillyl butyl ether. The amounts of menthol and vanillyl butyl ether (0.1) falls within the range recited in the instant claims (0.0833 to 0.1667).
The combination of the cooling and warming sensates signaled prolonged cooling effects to the user. Thus, the burning, tingling or bitter sensations associated with this warming sensate were able to convey to the user a better appreciation of the cooling sensate. One would reasonably conclude that the warming sensation was perceived first and therefore the cooling sensation was then appreciated by the user.
Nakatsu et al. differ from the instant claims insofar as they do not disclose the compositions comprise an abrasive or 1,2-alkane diols, but do disclose the compositions may be formulated into toothpaste.
Oertling et al. disclose products comprising a flavoring agent composition. The compositions are used for cleaning the teeth and include toothpastes (Abstract). A flavoring agent composition comprises peppermint oil, 0.5% methane carboxylic acid-N-(4-methoxyphenyl)-amide (WS-12, a TRPV1 agonist), cinnamaldehyde (TRPV1 agonist) and 40% menthol (Example 5.2). These amounts meet the ratio of the instant claims. A toothpaste comprising 5.2 comprises 36.39% water, 20% glycerin, sodium monofluorophosphate, 1% flavor (meets the amounts of menthol and TRPV1 agonist), 3% silica (an abrasive) and sodium carboxymethyl cellulose (Example 12). Combinations of WS-12 with diols are desired as a sugar substitute. The diols include 1,2-alkane diols such as 1,2-octanediol.
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. The composition of Nakatsu et al. may be used in oral care compositions such as toothpaste. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have used WS-12, 1,2-octanediol, silica and glycerin in the compositions of Nakatsu et al. for their suitability as a flavor, a sugar substitute, an abrasive and a humectant, respectively, in toothpaste compositions.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05. Nakatsu discloses vanillyl butyl ether is present in the composition from fraction (1/200) to 1 times the amount of the cooling agent on a weight basis. This overlaps the ratio of 5:60 to 10:60. Therefore the range of Nakatsu makes the range of the instant claims obvious.
Response to Arguments
The Examiner submits that although Nakatsu discloses no discernible warming effect, it does disclose the composition does have an initial warming effect, which would encompass the limitation of the instant claims. Further, it is disclosed that this is preferable making this a preferred embodiment and not the only embodiment. It was also disclosed that panelist described a composition having a fuller warming, tingling effect as compared to the comparative example (Comparative Example 1 and ref. claim 1). This indicates that the examples of the Nakatsu also have an initial warming effect as recited by the instant claims. In regards to the ratio, Nakatsu discloses the taste profiles may be changed based on the amount of each component. Therefore, it would have taken no more than the relative skill of one of ordinary skill in the art to have adjusted the amount of each component to obtain the desire warming or cooling effects. Further, the amounts used in Nakatsu are encompassed by the ratio range of the instant claims. In regards to WS-12 and cinnamaldehyde, these are disclosed in the secondary reference. It is agreed that them being TRPV1 agonist are not disclosed in Oertling et al. However Nakatsu discloses vanillyl butyl ether and therefore the combination still meets the limitations of the instant claims. In regards to the ratio, Nakatsu discloses vanillyl butyl ether in an amount of 0.05% and menthol in an amount of 0.5%, which would be a 1:10 ratio. This falls within the range recited by instant claim 1. Therefore the combination of Nakatsu and Oertling would have the proper weight ratio. Further Nakatsu does discuss the initial warming effect of its compositions. In regards to the alleged unexpected results, the claims are not commensurate in scope with the results. Claim 1 recited 5:60 to 10:60. The amount in an example of Nakatsu falls within this range. Therefore, the composition of Nakatsu meets this limitation and one would reasonably conclude that it would have substantially the same warming and cooling effects.
2) Claims 5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Nakatsu et al. (US 2003/0215532) in view of Oertling et al. (US 9,446,267) in further view of Modak et al. (US 2015/0265666).
Nakatsu et al. in view of Oertling et al. is discussed above and differs from the instant claims insofar as it does not disclose a hexanediol or the pH.
Modak et al. disclose antimicrobial compositions that may be formulated into toothpaste (paragraph 0020). The pH of the compositions ranges from 2 to 6 (paragraph 0061). Antimicrobials include alkanediol including hexanediol and octanediol, and combinations thereof, at a concentration of between about 0 and 10% w/w (paragraph 0067), this would meet the ratio of the TRPV1 and the alkanediol.
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. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have used hexanediol or a combination of hexanediol and octanediol in the compositions of Nakatsu et al. in view of Oertling et al. for their suitability and to obtain the antimicrobial activity.
Response to Arguments
The Examiner submits that Modak cures the deficiencies of Nakatsu et al. in view of Oertling et al. by disclosing hexanediol and octanediol. Therefore the rejection is maintained.
Conclusion
Claims 1-13 and 15 are rejected.
Claim 14 is 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 on Monday-Friday 11:00-7:30.
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/LEZAH ROBERTS/ Primary Examiner, Art Unit 1612