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 Appeal Brief, filed September 24, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
In view of the Appeal Brief filed on September 24, 2025, PROSECUTION IS HEREBY REOPENED. A new ground of rejection is set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/SAHANA S KAUP/ Supervisory Primary Examiner, Art Unit 1612
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, 3-7 and 9-10 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.
The claims recite “75% of the mint flavor composition is synthetic”. It is not clear what is encompassed by the term “synthetic”. Such does synthetic mean all the components were synthesized, racemic forms of naturally occurring mint components were used or if the amounts of naturally occurring mint components were varied insofar far as the ratios of the components are not found in nature.
Claim Rejections - 35 USC § 103 – Obviousness (Maintained Rejection)
1) Claims 1, 3-7 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Scholz et al. (WO 2007/115593) in view of Bridger et al. (US 2,662,052) in further view of Coleman et al. (J. of Chromatographic Sci., 1998).
Scholz et al. disclose compositions of menthyl lactate and mixtures of menthol as cooling agents (Abstract). The compositions may optionally comprise neoisomenthol, menthol and optionally neoisomenthol and/or isomenthol. The composition may comprise l-menthol, d-menthol or racemic menthol (page 11, lines 20-25). It is well known that menthol, most particularly l-menthol, exhibits the strongest and freshest sensory profile among menthol and its isomers. The menthol concentration can be in the range of 35% to 60%, preferably 40% to 55% (page 13, lines 17-20), which meets the peak area percent. A composition is disclosed comprising a mixture of racemic menthol and racemic menthone.
Scholz et al. differ from the instant claims insofar as they do not disclose the amount of menthone.
Bridger et al. disclose that mint oil comprises menthol and menthone. The oil from Mentha piperita usually contains 40% to 65% of menthol and 14 % to 40% of menthone (col. 1, lines 18-30). The amount of menthol meets the limitation of 40.0 by peak area percent of menthol. The amount 14% to 40% encompasses the amount of menthone, 21 to 26 of the instant claims.
It would have been obvious to one of ordinary skill in the art prior to the filing of the instant application to have used between 14% and 40% menthone in the composition of Scholz et al. because it is an amount found in natural mints such as Mentha piperita.
Further, the menthone is a result effective variable and contributes to the coolness and the flavor of the composition in which it is incorporated into. 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 menthone to obtain the desired coolness and flavor profile.
Scholz et al. in view of Bridger et al. differs from the instant claims insofar as it does not disclose the mints are synthetic.
Coleman et al. disclose that menthol occurs naturally in oils of the Mentha species in the (1R,3R,4S)-(-) form (l-menthol), whereas synthetic menthol is available either in the same form or as a racemic mixture (d- and l-menthol) (Abstract). Synthetic menthol generally does not contain impurities (page 319, col. 1, second paragraph).
It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have used synthetic mint flavor components motivated by the desire to use a menthol with less impurities and to control the amount of each isomer present in the menthol.
The amount of each menthol, comprise l-menthol, d-menthol or racemic menthol, affects the taste and cooling function of the composition into which they are incorporated. This makes them result effective variables. It would have taken no more than the relative skill of one of ordinary skill in the art to have adjusted the amounts of different forms of menthol when used in mixtures to obtain an optimal cooling effect.
In regards to the Lei-Hoke Methods, the composition comprises and suggests the instant claimed percentages and therefore one would reasonably conclude that these would correspond to the peak percentages obtained by the Lei-Hoke Methods of the instant claims.
Response to Arguments
The Examiner submits that in regards the ratio of (-)-menthol and (+)-menthol, Scholz does not appear to give the ratio of the two. Therefore, the ratio of the two is not necessarily 1:1. No where does Applicant point out where a 1:1 enantiomeric ratio is disclosed in Scholz. Scholz prefers racemic mixtures of menthol. Therefore, one of ordinary skill in the art would reasonably conclude that there is a benefit from having (+)-menthol in the disclosed composition and (+)-menthol provides a desired property, or Scholz would have preferred the naturally occurring (-)-menthol form. In regards to l-menthol being the only form imparting a cooling effect, as stated, one would reasonably conclude that there was a benefit in using (+)-menthol with (-)-menthol. Therefore, it would have been obvious to one of ordinary skill in the art to have adjusted the ratio of (+)-menthol and (-)-menthol to get the desired cooling profile. In regards to the data on page 44, it appears inventive Example 2 is comparable to commercially available compositions. It is not clear how this relates to changing the racemic ratio of (+)-menthol and (-)-menthol or how this result is unexpected considering Example 2 comprises components in natural mint oils. In regards to the figures, only Figures 2 and 8 appear to have a ratios of (+)-menthol and (-)-menthol. In regards Figure 2, the peak areas of the examples appear to be comparable to the peak areas of the comparative examples. In regards to Figure 8, it is not clear if the numbers are based on ratios or total amounts. Also, there appears to be no detailed explanation of the figures in the instant specification. In regards to Coleman teaching away from using racemic mixtures, Coleman discloses “Only l-menthol imparts the well-known desired cooling effect”. This does not necessarily mean that (+)-menthol does not have a cooling effect nor does this necessarily teach away from using racemic mixtures, this only indicates that l-menthol has a well-known cooling effect. As can be seen in Scholz et al., racemic mixture are suitable for flavor mixtures. Considering Coleman was published before Scholz et al., Coleman’s teaching do not appear to teach away from using racemic mixtures. In regards to the motivation to make a specific combination, each component would lead to a specific taste and cooling effect. One would be motivated to use a specific combination to obtain as specific effect. In regards to the ratio, this is a result effective variable and would control the cooling effect and also the flavor effect. Therefore it would have taken no more than routine experimentation to arrive at the instantly claimed ratio to get the desired cooling effect. In regards to using synthetic mint flavors, one would be able to create the desired cooling and flavor profile by synthetically making a mint composition. Further, one would be able to avoid impurities found in natural mint oil by making a synthetic mint oil. Therefore, making a synthetic mint oil is obvious. In regards to Coleman only stating l-menthol provides the desired cooling effect, Coleman states the l-menthol provides a well-known cooling effect. This does not teach away from d-menthol having a cooling effect. In regards to a result-effective variable, Coleman teaches the l-menthol has a cooling effect. This indicates that the amount of l-menthol used will affect the cooling profile of a composition making l-menthol a result effective variable. When d-menthol is used in combination with l-menthol such as in a racemic mixture, one of ordinary skill in the art would reasonably conclude that this would affect the cooling profile because it would affect the amount of l-menthol present. Therefore, (+)-menthol and (-)-menthol are result effective variables. In regards to no data in Coleman, (+)-menthol and (-)-menthol have cooling properties. Therefore, one of ordinary skill in the art would recognize that changing their amounts and ratios would affect the cooling profile of a composition. Therefore, it is agreed with Applicant that Coleman does support a finding that the peak area ratio of (+)-menthol and (-)-menthol recited in the instant claims is a result effective variable. Thus, it would have been obvious to one of ordinary skill in the art to adjust the ratio to get the desired effect. In regards to guidance, the references disclose that certain mixtures of components found in mint produce different cooling and flavor profiles. This would prompt one of ordinary skill in the art through routine experimentation to adjust the amounts of components to yield a mint flavor with a specific flavor or cooling profile. Menthone is a result effective variable because it affects the cooling and flavor profile of a mint oil. Further menthone is found in mint oil in a certain amount. Scholz also discloses adding menthone to its compositions. Therefore, it would have been obvious to have used menthone in amount found in natural mint oil to make a mint oil that is similar to one found in nature. Further, menthone is not necessarily being optimized, it is being used in an amount found in natural mint oil. In regards to Bridger, Bridger was purifying menthol. There appears to be no negative disclosure regarding menthone. In regards to the results of making a mint flavor comparable to naturally derived mint oil, this does not seem to be unexpected when using components found in natural mint in amounts found in natural mint. Further, the ratio has more naturally occurring menthol than l-menthol. Therefore, one would conclude that a mint oil similar to a natural mint oil could be made. Therefore the rejection is maintained.
Conclusion
Claims 1, 3-7 and 9-10 are rejected.
Claims 11-24 are withdrawn.
No claims allowed.
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/LEZAH ROBERTS/ Primary Examiner, Art Unit 1612