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 .
This office action is in response to the reply filed 7/6/2026.
Election/Restrictions
Claims 12-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group and/or species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 10/17/2024.
Response to Arguments
All of Applicant arguments filed 7/6/2026 have been fully considered and are not persuasive.
112 Rejections
In view of the filed amendments, the 112b rejections presented in the office action mailed 4/6/2026 have been overcome and are thus withdrawn.
103 Rejections
Applicant argues that the claims require a weight ratio between components (a) and (b) that is not disclosed by the cited references and there is no motivation to have selected the claimed amounts to improve long-lasting cooling profile and remarks that the claimed ratio is not a result of routine optimization as neither reference identified the relative amount of phenylalkenal to homovanillic ester as a result effective variable.
This is not persuasive. As discussed below, Lages teaches that the phenylalkenals for formula (I) are preferably used in amounts ranging from 1-99% and the cooling agents such as menthol are used in amounts of 99-1% [0034-0035], which overlap with the amounts recited by the instant claims. Backes exemplifies that the homovanillic acid esters should be used in amounts which increase pleasant taste sensation of the cooling agent, but in amounts which are not sufficient to a warm or pungent effect on the tongue or in the oral cavity and these are typically 100-100,000 mg/kg based in the total weight of the composition. (Backes – claims 6-7 and 10). It would have been prima facie obvious to optimize the amounts of 2-phenyl-2-(4-hydroxy-3-methoxyphenyl) acetate used in the composition, along with the amounts of phenyalkenals, to ensure adequate increased taste sensation without allowing for a warm or pungent effect on the tongue or in the oral cavity and to ensure adequate cooling effect. This makes obvious optimizing the weight ratio between components (a) and (b) to obtained an adequate cooling effect and/or taste sensation. MPEP 2144.05 II: "Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.)"
Applicant argues that the previously filed declaration demonstrates the improved long-lasting cooling that is not achievable by the individual or binary comparative compositions.
This is not persuasive. In order to establish unexpected results, Applicant must compare the instant invention to the closest prior art which is Lages who teaches the claimed components (a) and (c), this corresponds to table 4 of the declaration. As such the examiner will focus her discussion on comparing the data of tables 4 and 5. While there does seem to be some improved effect with respect to the intensity of the cooling sensation after 5 min and after 10 min, the data is not persuasive. The data presented in not commensurate in scope with the claims. Applicant have tested 2 species of phenylalkenyl (phenyl butenal and phenyl pentenal) with 1 species of homovanillic acid ester and a limited number of additional physiological cooling agents all in one concentration amount. The claims are directed to a much broader genus of all of these components. It is also noted that components (a) : (b) and (c) : (b) are always tested at a 1:5 ratio, but the claims do not reflect this. The data presented lacks a nexus to the claimed invention as the claims only require components (a), (b) and (c) however the examples tested comprise a multitude of unclaimed ingredients. Applicant also provides no evidence that the differences shown in the tables are statistically significant. Applicant has provided no error bars or other explanation of the data suggesting the results represent a single experiment. See McNeil-PPC, Inc. V. L. Perrigo Co., 337 F.3d 1362, 1370 (Fed. Cir. 2003) (Finding evidence unpersuasive that "was based on the results of a study involving only nine participants and thus did not rise to the level of statistical significance" and finding the studies were "not shown to be reproducible."). Therefore "even assuming that the test methodology were valid, the test results were not statistically significant. These are all determinations of credibility, reliability, and weight." Novartis Pharm. Corp. V. Watson Labs., Inc., 611 Fed. Appx. 988, 999 (Fed. Cir. 2015).
Maintained Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-9 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lages (US 2015/0139918) and Backes (WO2015/158677).
For ease of examination, the Examiner relied upon US Publication 2019/0276386 as an equivalent English translation of the German WO 2015/158677 publication. All citations henceforth to Backes are locations in the US Patent.
Lages teaches mixtures having improved cooling (this reads on cooling preparation as recited by instant claim 1). The mixtures contain at least one phenylalkenal of formula (I) and at least one physiological cooling agent (Abs).
Lages teaches the phenylalkenal to have the formula:
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475
666
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[0006].
A preferred phenylalkenal for use includes 2-phenyl-but-2-enal (elected species), which reads on instant claims 1(a), 2 and 3.
Lages teaches that this mixture has an intensified cooling effect, without intensifying the undesirable properties of the physiological cooling agents, such as stinging, burning or bitterness [0008].
Regarding claims 8 and 9: Lages teaches that the physiological cooling agents (b) comprise substances such as menthol, menthyl esters, etc. [0016].
However, Lages does not teach the mixture to further comprise a homovanillic ester of formula (II).
Backes teaches the use of homovanillic esters (Abs). The homovanillic ester are taught to have the formula:
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219
604
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(Backes – claim 1).
A suitable compound for use includes
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297
652
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(reading on elected species and instant claims 1(b) and 4-7).
Backes teaches that the homovanillic acid ester can be used for increasing a pleasant taste sensation, such as a cooling sensation (selected from a finite number of options) [0024-0029].
Backes teaches that the amount of homovanillic acid esters used in the composition is not sufficient to create a warming or pungent effect on the tongue or oral cavity, but is sufficient to mask or reduce an unpleasant taste sensation of unpleasant tasting substances or mixtures of substances [0072].
Backes teaches that the composition can further comprise substances with physiological cooling effects, such as menthol and its derivatives, menthyl ester, etc. [0116].
Backes teaches that flavor composition which comprise homovanillic acid esters and other trigeminally (i.e. such as cooling) substances are advantageous as the trigeminal effect can be advantageously modulated by the homovanillic acid esters. For example, a cooling effect can be amplified [0119].
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Lages with those of Backes. One of skill in the art would have been motivated to add a homovanillic acid ester such as 2-phenyl-2-(4-hydroxy-3-methoxyphenyl) acetate as taught by Backes into the composition of Lages as Backes teaches that the 2-phenyl-2-(4-hydroxy-3-methoxyphenyl) acetate can be used to amplify the cooling effect of cooling substances and Lages teaches cooling mixtures having improved cooling. One of skill in the art would have a reasonable expectation of success as Backes teaches that the homovanillic acid esters can be used in combination with physiological cooling substances, such as menthol, which is also taught by Lages. Furthermore, both Backes and Lages teach using compounds (homovanillic acid ester or phenylalkenyls) in combination with cooling substances such as menthol to provide improved or amplified cooling and its prima facie obvious to combine two compositions which are individually taught to be used for the same purpose (improved cooling) in order to create a new composition for the same purpose.
Regarding weight ratio between components (a) and (b) in claim 1 and the amounts in claim 11: Lages teaches that the phenylalkenals for formula (I) are preferably used in amounts ranging from 1-99% and the cooling agents such as menthol are used in amounts of 99-1% [0034-0035], which overlap with the amounts recited by the instant claims. Backes exemplifies that the homovanillic acid esters should be used in amounts which increase pleasant taste sensation of the cooling agent, but in amounts which are not sufficient to a warm or pungent effect on the tongue or in the oral cavity and these are typically 100-100,000 mg/kg based in the total weight of the composition. (Backes – claims 6-7 and 10). It would have been prima facie obvious to optimize the amounts of 2-phenyl-2-(4-hydroxy-3-methoxyphenyl) acetate used in the composition, along with the amounts of phenyalkenals, to ensure adequate increased taste sensation without allowing for a warm or pungent effect on the tongue or in the oral cavity and to ensure adequate cooling effect. This makes obvious optimizing the weight ratio between components (a) and (b) to obtained an adequate cooling effect and/or taste sensation.
Regarding the limitations of components (a)-(c) adding to 100%, the prior art makes obvious a composition comprising the three claimed ingredients, no other ingredients are required by Lages, as such the amounts of ingredients (a)-(c) would make up 100% of the composition.
Conclusion
No claims are allowable.
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 Jennifer A Berrios whose telephone number is (571)270-7679. The examiner can normally be reached Monday-Thursday from 9am-4pm and Friday 9am-3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached on (571) 272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JENNIFER A BERRIOS/Primary Examiner, Art Unit 1613
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