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 .
Response to Arguments
Applicant’s arguments with respect to claims 1-8 have been considered but are moot in view of the amendments filed 7/13/2026. All rejections and objections have been withdrawn in view of amendment and new rejections have been issued. The arguments in the response filed 7/13/2026 will be addressed below to the extent that they apply to the current rejections.
Regarding Applicant’s assertion that assembling the claimed components at the recited amounts could be accomplished only by impermissible hindsight, as noted in MPEP 2145, any obviousness rejection is in a sense necessarily a reconstruction based on hindsight reasoning and is not improper if it takes into account only knowledge within the level of ordinary skill in the art at the time the claimed invention was made. Applicants have provided no evidence that any rejection was not based on knowledge available to those of ordinary skill in the art.
Claim Rejections - 35 USC § 112
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 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.
Claim 9 recites “A cooling formulation for topical application, said cooling formulation comprising: a concentrate comprising, by volume … ”. The scope of the claim is indefinite as it is unclear if the percentages recited are by volume of the concentrate or by volume of the total formulation. Additionally, the relative amounts of the concentrate and propellant phase are never defined. It is never recited if, for example, the concentrate is 90% by volume of the total formulation and the propellant phase is 10% by volume of the total formulation. As a result, it is unclear what percentages of each component are present in the total formulation, i.e. the resulting structure of the final composition. For purposes of compact prosecution, the recited percentages are being interpreted as percentages by volume of the total formulation, as suggested in the instant Specification at, for example, paragraph 0014.
Claim 10 recites “relative amounts”. This renders the scope of the claim indefinite as it is unclear what the amounts are relative to, for example, if they are relative to the propellant phase or to the entire composition. Furthermore, claim 10 recites amounts of each propellant “in parts” but does not specify if the parts refer to, for example, parts by weight or parts by volume, mole fraction etc. Additionally, it is unclear if the recited values are meant to express a ratio, or if the recited values are “per hundred parts” as is sometimes used to express a percentage. For purposes of compact prosecution, if the prior art teaches the claimed values, it will be considered to meet the instant claim limitations.
Examiner Comments
The Examiner has cited particular columns and line numbers, paragraphs, or figures in the references as applied to the claims for the convenience of the Applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested from the Applicant, in preparing the responses, to fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner.
The instant claims recite amounts in percentages by volume. The prior art conventionally recites concentrations and amounts in percentages by weight/mass, instead of volume, since volume changes with environmental conditions whereas mass is constant independent of temperature and pressure. As a result, the Examiner has used the following values as approximate equivalents of the claimed amounts, wherein the volumes have been converted to percent by mass using the densities of the individual components (see attached Substance Details for densities).
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Calculations were performed by representing the claimed volume percentages as volumes in mL, resulting in a total concentrate volume of 97.5 mL, with the volume of the total cooling formulation being assumed to be 100 mL to accommodate for the propellant phase and other unrecited elements, as allowed for by “comprising” language.
Example Calculation:
Ethanol: 75 mL x 0.789 g/mL = 59.175 g
Total weight of the concentrate = 80.1615 g
59.175 g / 80.1615 g x 100 = 73.81973% by weight of the total composition
As discussed above in the 112(b) rejection of claim 9, the amounts are being interpreted as percentages with respect to the total composition. Paragraph 0014 of the Specification recites 2.0% chamomile oil, wherein the recited percentage is of total final volume, thus, the calculated values should be consistent with the claimed values (i.e. the calculations are performed using 2 mL of chamomile oil out of 100 mL of the total composition, which is equivalent to 2% chamomile oil by volume of the total composition, as indicated in the Specification).
New Claim Rejections - 35 USC § 103
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.
Claims 9-13 and 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Flugge-Berendes et al. (US 2008/0085290 A1, published 4/10/2008), in view of Lynch et al. (US 2021/0315784 A1, published 10/14/2021), Rusch et al. (published online 6/8/2016), Patron et al. (US 2019/0177308, published 6/13/2019), Kuper et al. (US 2019/0099342 A1, published 4/4/2019), Bucks et al. (US 2021/0100759 A1, published 4/8/2021), and Singh et al. (US 2009/0305876 A1, 12/10/2009).
Examiner would first like to note that the instant recitation of “for topical application” in the preamble of claim 9 is interpreted as intended use and does not constitute a functional limitation. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. MPEP 2111.02. In the instant case, the preamble does not add a structural distinction to the claim. As the prior art makes obvious anticipates the claimed composition, the limitations of the claim are considered to have been met.
Additionally, for all rejections, the concentrations/amounts taught in the prior art will be considered to read on the instantly claimed volume percentages if they read on the equivalent calculated mass percentage values in the table above, as discussed in the Examiner Comments.
Regarding claims 9-10, Flugge-Berendes teaches a skin cooling composition [0001] comprising a neurosensory component [0026] and an evaporative cooling component [0036]. The neurosensory component may comprise of menthol, menthol derivatives, methyl salicylate (reads on wintergreen oil, see SciFinder Substance Detail for Wintergreen Oil) and chamomile [0034]. Flugge-Berendes does not explicitly teach menthyl ethylamido oxalate. Lynch teaches that cooling sensates are common ingredients in a variety of topical skincare compositions [0075]. Lynch further teaches that menthol and its derivatives, including menthyl ethylamido oxalate, are suitable equivalents for inclusion in skincare compositions [0079-0082]. The selection of a known material based on its suitability for its intended use is prima facie obvious. MPEP 2144.07. Thus, it would be prima facie obvious to select menthyl ethylamido oxalate as a suitable cooling menthol derivative in the composition of Flugge-Berendes. Additionally, the substitution of equivalents known for the same purpose is prima facie obvious. MPEP 2144.06.
Flugge-Berendes further teaches that the neurosensory component may be present in the amount of about 0.1% to about 5% [0035]. It would be obvious to include any of the neurosensory components in the amounts that neurosensory components are taught to be suitable in. This overlaps and makes obvious the instantly claimed amounts of menthyl ethylamido oxalate, wintergreen oil, and chamomile oil. MPEP 2144.05.
Flugge-Berendes teaches that the composition further comprises an evaporative cooling component, which may comprise of ethanol in the amount of about 5% to about 75% [0037-0038]. This overlaps with and makes obvious the instantly claimed amount of ethanol. MPEP 2144.05. Flugge-Berendes further teaches that the evaporative component may comprise of hydrocarbons [0037]. Flugge-Berendes does not explicitly teach that the hydrocarbon is n-pentane. Rusch teaches that hydrocarbons such as propane, n-butane, and n-pentane are active ingredients in vapocoolant sprays [pg. 78]. The selection of a known material based on its suitability for its intended use is prima facie obvious. MPEP 2144.07. Thus, it would be obvious to modify the teachings of Flugge-Berendes with that of Rusch, and select n-pentane as the hydrocarbon comprising the evaporative cooling component (i.e. vapocoolant) in the composition of Flugge-Berendes. Flugge-Berendes does not explicitly teach an amount of hydrocarbon that may be present in the composition. However, Flugge-Berendes teaches other evaporative cooling components, such as water and alcohols, in amounts ranging from 5% to 95% [0038]. Furthermore, differences in concentration will generally not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. MPEP 2144.05. Flugge-Berendes teaches that the percentage of cooling compounds in the composition may vary depending on the desired application of the composition, and variability in the ingredients is acceptable so long as the cooling composition provides sufficient cooling of the skin (i.e. not critical) [0035]. "[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). In the instant case, Flugge-Berendes teaches that different amount of cooling agents can be used to generate a desired feeling [0017], thus, one of ordinary skill would be able to accordingly adjust and optimize the amount of n-pentane present in the cooling composition and arrive at the instantly claimed amount of about 5% by volume.
Flugge-Berendes does not explicitly teach that the composition comprises about 5% of diisopropyl adipate. Patron teaches cooling compositions comprising TRPM8 channel modulators [0004], and further teaches that cooling compositions may comprise of a skin penetration enhancer such as diisopropyl adipate [0148]. The skin penetration enhancer may be present in the amount of 5% to 30% [0153]. It would be obvious to include diisopropyl adipate, a skin penetration enhancer, in the amount that is taught to be suitable for skin penetration enhancers. The range taught in the prior art overlaps with and makes obvious the instantly claimed range. MPEP 2144.05. It would be obvious to a skilled artisan to modify the teachings of Flugge-Berendes with that of Patron, and formulate the cooling composition with a skin penetration enhancer such as diisopropyl adipate, in order to improve the composition’s ability to penetrate the skin, thus improving the efficacy of the active ingredients in the composition.
Flugge-Berendes does not explicitly teach that the composition comprises about 4.5% of PEG-8 dimethicone. Kuper teaches a topical cooling composition comprising 5-methyl-2-(propane-2-yl)cyclohexyl-N-ethyloxamate (i.e. menthyl ethylamido oxalate) [claim 2] and a silicone, such as PEG-8 dimethicone [0050]. Kuper further teaches that silicone compounds may provide an occlusion effect which results in improved exposure of the skin to the cooling substance, and improve skin moisture which facilitates penetration of the cooling substances [0048]. Thus, it would be obvious to one of ordinary skill, before the effective filing date of the claimed invention, to modify the teachings of Flugge-Berendes with that of Kuper, and add a silicone such as PEG-8 to the composition of Flugge-Berendes to help moisturize the skin and improve the efficacy and penetration of the cooling compounds [0048]. Kuper teaches that for cosmetic (i.e. topical) compositions, silicones may be present in the amount of 1% to 50% by weight of the composition. It would be obvious to include PEG-8 dimethicone in the amount that silicones are taught to be suitable in. The amount taught in the prior art overlaps with and makes obvious the instantly claimed range. MPEP 2144.05.
Flugge-Berendes does not explicitly teach that the composition comprises about 2% clove bud oil. Bucks teaches a topical composition comprising analgesic agents and TRPV1 selective agonists [Abstract]. Bucks further teaches that phenolic compounds cool and numb skin on contact [0130], and maybe be included in a topical composition in the amount of up to 4.6% [0130]. Bucks further teaches that clove oil may be used as an alternative equivalent [0131]. Thus, it would be obvious to include clove oil, an alternative for phenolic compounds, in the amount the phenolic compounds are taught to be suitable in. The amount taught in the prior art overlaps with and makes obvious the instantly claimed amount. MPEP 2144.05. Combining equivalents known for the same purpose is prima facie obvious. MPEP 2144.06. Thus, it would be obvious to one of ordinary skill to add clove oil to the cooling composition of Flugge-Berendes, as clove oil also has cooling properties. Furthermore, clove oil has analgesic, anti-inflammatory, and antibacterial effects [0034]. It would be obvious to one of ordinary skill, before the effective filing date of the claimed invention, to modify the teachings of Flugge-Berendes with that of Bucks, to include clove oil in the composition for additional benefits such as analgesic, anti-inflammatory, and antibacterial effects.
Flugges-Berendes teaches that the cooling composition may be administered as an aerosol [0048], but does not explicitly teach the instantly claimed propellant phase. Singh teaches a composition comprising fluorinated alkenes that is suitable for use as a propellant [Abstract; 0226 et seq.]. The composition of Singh may further comprise of 1,1,1,2-tetrafluoroethane (HFC-134a) [0059], 1,1,1,3,3-pentafluoropropane (HFC-245fa) [0063], propane [0229], isobutane [0229], and n-butane [0229]. Singh teaches that the relative amounts of any of components of the propellant composition can vary widely [0067] and further teaches that the composition may comprise from 1-99% by weight of trans- or cis-trifluoromonochloropropene (HFCO- 1233zd) and at least one additional compound, wherein the compound may comprise 1% to 99% of 1,1,1,2-tetrafluoroethane (HFC-134a), 1% to 99% of 1,1,1,3,3-pentafluoropropane (HFC-245fa), 1% to 99% of propane, 1% to 99% of isobutane, and 1% to 99% of n-butane [pg. 13-14, Table: Combinations with HFCO-1234zd]. The ranges taught in the prior art overlap with and make obvious the instantly claimed amounts of instant claim 10. MPEP 2144.05. Singh teaches that its propellant composition is suitable for aerosol applications [0068]. Selection of a known material for its suitability is prima facie obvious, thus one of ordinary skill would modify the teachings of Flugge-Berendes with that of Singh and utilize the composition of Singh as the propellant phase for use in an aerosol application of the cooling composition of Flugge-Berendes. MPEP 2144.07.
Regarding claim 11, Singh teaches that the propellant composition may be formulated as a sprayable composition such as a medicinal/therapeutic composition comprising drugs or biologically active substances [0228]. The composition may also be applied to human tissue for therapeutic purposes such as pain relief or reducing body temperature [0239]. Singh teaches that the evaporation of the composition from the sprayed surface (body part) causes cooling of the surface (i.e. acts as a vapocoolant) [0239].
Regarding claim 12, Singh teaches that the application of the composition for cooling may be provided wherein the composition is contained within a pressurized container having a discharge valve [0239]. Singh further teaches that the propellant composition is preferably an aerosol, and suitable materials to be sprayed include cosmetic and therapeutic/medicinal compositions [0228]. Thus, it would be obvious to use the propellant of Singh in conjunction with the composition of Flugge-Berendes, provided within an aerosol container, as selection of a known material for its suitability is prima facie obvious. MPEP 2144.07.
Regarding claim 13, Flugge-Berendes teaches that the topical composition may comprise of pain relievers [0042]. Under the broadest reasonable interpretation, this is considered to read on topical anesthetic.
Regarding claim 15, Flugge-Berendes teaches that the composition may comprise of therapeutic agents such as antimicrobial agents, antiseptics, and anti-inflammatories, but does not explicitly teach tea tree oil. Bucks teaches that tea tree oil has analgesic, antiseptic, anti-fungal, anti-bacterial, and anti-inflammatory properties [pg. 11, Table]. The selection of a known material based on its suitability for its intended use is prima facie obvious. MPEP 2144.07. Thus, it would be obvious for a skilled artisan to modify the teachings of Flugge-Berendes with that of Bucks and include tea tree oil in the cooling composition for its aforementioned properties.
Regarding claim 16, this claim recites the limitation wherein the menthyl ethylamido oxalate modulates TRPM8 receptors to active cool skin upon application. This limitation is a recitation of an inherent property. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. MPEP 2112.01.
Regarding claim 17, Flugge-Berendes does not explicitly teach a composition further comprising an agent that blocks TRPV1 receptors. Flugge-Berendes teaches that the cooling composition may comprise of pain relievers [0042]. Bucks teaches a topical composition comprising a TRPV1 selective agonist compound, such as capsaicin, for the treatment of pain [0099]. Bucks further teaches that the combination of a TRPV1 selective agonist with a topical analgesic compound such as methyl salicylate (wintergreen oil) and menthol or other TRPM8 agonists [0104; 0127] helps alleviates the side effects associated with capsaicin such as stinging and burning [0100]. Thus, it would be obvious to one of ordinary skill, before the effective filing date of the claimed invention, to modify the teachings of Flugge-Berendes with that of Bucks and include a TRPV1 receptor agonist such as capsaicin in the cooling composition for pain relief, as (1) selection of a known material based on its suitability for its intended use is prima facie obvious (MPEP 2144.07), and (2) because the prior art teaches that the combination of methyl salicylate and TRPM8 (i.e. the active ingredients in the composition of Flugge-Berendes) with capsaicin helps to alleviate unpleasant side effects of capsaicin.
Regarding claim 18, Flugge-Berendes teaches that neurosensory components such as wintergreen oil and chamomile may be present in the amount of about 0.1% to about 5% [0034-0035]. Bucks teaches that clove oil may be present in the composition in an amount of up to 4.6% [0130-0131]. The discussion on the rationale for combining Flugge-Berendes and Bucks will not be repeated herein, see above rejection of claims 9-10. Flugge-Berendes teaches that the percentage of cooling compounds in the composition may vary depending on the desired application of the composition, and variability in the ingredients is acceptable so long as the cooling composition provides sufficient cooling of the skin (i.e. not critical) [0035]. "[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). In the instant case, Flugge-Berendes teaches that different amount of cooling agents can be used to generate a desired feeling [0017], thus, one of ordinary skill would be able to accordingly adjust and optimize the amount of wintergreen oil, chamomile oil, and clove oil and arrive and the instantly claimed amount of about 5% to about 10% by volume. Furthermore, the amounts taught in the prior art overlap with and make obvious the instantly claimed amount; for example, the prior art teaches ranges that encompass 3% of each of the claimed compounds, which would equate to a total amount of 9%. MPEP 2144.05.
Regarding claim 19, Flugge-Berendes teaches that other additives may be included in the cooling composition including carriers, stabilizers, and preservatives [0044].
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Flugge-Berendes et al. (US 2008/0085290 A1, published 4/10/2008), Lynch et al. (US 2021/0315784 A1, published 10/14/2021), Rusch et al. (published online 6/8/2016), Patron et al. (US 2019/0177308, published 6/13/2019), Kuper et al. (US 2019/0099342 A1, published 4/4/2019), Bucks et al. (US 2021/0100759 A1, published 4/8/2021), and Singh et al. (US 2009/0305876 A1, 12/10/2009), as applied to claim 9 above, and further in view of Zhang et al. US 2014/0113971 A1, published 4/24/2014, cited in the O.A. dated 1/12/2026).
Regarding claims 13-14, Flugge-Berendes teaches that the topical composition may comprise of pain relievers [0042]. Zhang teaches a topical pharmaceutical composition comprising a topical NSAID analgesic and a sensate [0003] such as menthol and menthol derivatives [0038]. Zhang further teaches that the composition may comprise of topical anesthetics such as benzocaine, lidocaine, and tetracaine [0016]. The selection of a known material based on its suitability for its intended use is prima facie obvious. MPEP 2144.07. It would be obvious to a skilled artisan to modify the teachings of Flugge-Berendes with that of Zhang and select any of the disclosed topical anesthetics for inclusion in the composition of Flugge-Berendes to provide pain relief.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 AMANDA LYNN CHI whose telephone number is (571)272-0026. The examiner can normally be reached Monday - Friday 9 am-5pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at 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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/AMANDA LYNN CHI/Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
