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 in the Request for Continued Examination, filed May 11, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Claim 15 is 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 15 is dependent on a cancelled claim. It is not clear as to all the limitations that are encompassed by the claim making it indefinite.
Claim Rejections - 35 USC § 103 – Obviousness (Revised Rejection)
1) Claims 1, 8-13 and 15-16 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). The rejection is withdrawn in regards to claims 3-7.
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.
A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. 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 is close to the ratio of 7:60 to 9:60. One of ordinary skill in the art would reasonably conclude that the compositions of Nakatsu would have similar properties as that of the instant claims. Therefore the range of Nakatsu makes the range of the instant claims obvious.
Response to Arguments
The Examiner submits that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. 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 is close to the ratio of 7:60 to 9:60. One of ordinary skill in the art would reasonably conclude that the compositions of Nakatsu would have similar properties as that of the instant claims. Nakatsu also 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. Therefore, the range of Nakatsu makes the range of the instant claims obvious. The ratios are close enough that one of ordinary skill in the art would reasonably conclude that the composition of Nakatsu would have substantially the same properties, such as having a dominant warming sensation during brushing from 60 to 120 seconds followed by a dominant cooling sensation after expelling the dentifrice. Although this property is not taught, one would reasonably conclude that because the composition of Nakatsu comprises vanillyl butyl ether and menthol, the composition would have substantially the same properties. In regard to the warming happening with cooling, the claims say dominant warming. This does not limit the function of the composition to have only a warming or cooling sensation. Further, Nakatsu discloses the composition does have an initial warming effect, which would encompass the limitation of the instant claims. The claims also do not appear to limit how the warming effect occurs or components in the recited composition. The claims recite that a dominant warming effect occurs, not only a warming effect occurs.
The rejection is withdrawn in regards to claims 3 to 7.
Allowable Subject Matter
Claims 3-7 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Claim 3 recites specific diols providing a function that is not disclosed or suggested by the prior. Although Nakatsu discloses a composition comprising a vanillyl butyl ether and menthol that may also comprise a diol, Nakatsu does not disclose the specific diols. One of ordinary skill in the art would not expect the diol to mitigate against the lowering of a pain threshold in the oral cavity when using vanillyl butyl ether when the diol is added based on the prior art of record.
Applicant is reminded that if the claims are amended to in condition for allowance, any withdrawn claims may be considered if in scope with the allowable claim.
Conclusion
Claims 1, 8-13 and 15-16 are rejected.
Claims 3-7 are objected.
Claim 14 is withdrawn.
No claims allowed.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached on 571-272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LEZAH ROBERTS/ Primary Examiner, Art Unit 1612
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