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 3, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 Objections
Claims 4-5, 8-10, 14, 17 and 20 are objected to because of the following informalities: The claims recite “2’-HOPP” without first defining the acronym. Appropriate correction is required.
Claim Rejections - 35 USC § 103 – Obviousness (Maintained Rejection)
Claims 4-5, 8-10, 14, 17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Greenberg (US 5795616) in view Shiley et al. (1979).
Greenberg discloses 2’-hydroxypropionphenone is used as a flavorant to enhance the flavor of wintergreen-flavored products and contribute a wintergreen note to non-wintergreen-flavored products (Abstract). The products comprise zinc salt such a zinc oxide (Example 8). The 2'-hydroxypropiophenone is used as an enhancement, or as complete or partial replacement for methyl salicylate in chewing gum, foods, dentifrices, mouthwashes and other orally consumable compositions. Methyl salicylate itself is known to be toxic at dosage levels well above those found in oral products. While products flavored with methyl salicylate have gained widespread consumer acceptance, the use of such a compound with pharmaceutical properties and a degree of toxicity poses a potential risk of adverse publicity or governmental regulation which could limit the level at which it may be used, or prohibit it entirely. The availability of a replacement compound for methyl salicylate would be highly desirable (col. 1, lines 13-35). The composition had a good taste (Example).
Greenberg differs from the instant claims insofar as it does not disclose Methyl 4-fluoro-2-hydroxybenzoate.
Shirely et al. disclose fluoroaromatic compounds are used as agrichemicals. The fluoroaromatics include methyl-2-fluoro-6-hydroxybenzoate. They are used to keep plants healthy. Plants include those that are used as food, making them orally acceptable.
Methyl-2-fluoro-6-hydroxybenzoate has a structure similar to that of methyl salicylate, where a fluorine is substitutes a hydrogen on the aromatic ring. When chemical compounds have “very close” structural similarities and similar utilities, without more a prima facie case may be made. Stated alternatively, obviousness may be based solely upon structural similarity (an established structural relationship between a prior art compound and the claimed compound, as with homologs). Methyl salicylate has been disclosed to be toxic when used in higher amounts. Therefore, it would have been obvious to one of ordinary skill in the art to have substituted methyl-2-fluoro-6-hydroxybenzoate for methyl salicylate in the composition of Greenberg comprising 2'-hydroxypropiophenone motivated by the desire to use a compound that has less toxicity and structurally similar to methyl salicylate. One would reasonably expect the methyl-2-fluoro-6-hydroxybenzoate to have a wintergreen aroma because they are similar structure to methyl salicylate.
Greenberg does not disclose the components of claims 8-10, 14, 17 and 20. Therefore, the compositions would be essentially free of these components.
Response to Arguments
The Examiner submits that Greenberg discloses compositions with a certain flavor profile. Therefore, one would conclude that it would mask bitter off taste. Further, the claims recite a composition and not a method. Masking the taste is intended use. Therefore a composition with the active would meet the limitation of the instant claims. The secondary reference was used to show that the compound was known in the art and would be safe to be used in an oral composition. One of ordinary skill in the art would recognize the structural similarity and would be motivated to use it because of its structural similarity. The substitution is supported by MPEP 2144.09. “A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." Due to the close similarity, one would reasonably expect that the compound of Shiley would have the same properties as methyl salicylate when looking for a safer alternative for methyl salicylate, absent of evidence to the contrary. In regards to Shiley not being analogous art, it was used to show the compound has already been made and is safe to use on orally consumed products. This shows it is suitable for oral compositions. Therefore the rejection is maintained.
Conclusion
Claims 4-5, 8-10, 14, 17 and 20 are rejected.
Claims 1-3, 6, 15 and 18 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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