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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/08/2026 has been entered.
Response to Amendment
Applicant's amendment and argument filed 04/08/2026, in response to the final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 1-26 are pending of which claims 7, 9, 17-23 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made with traverse in the reply filed on 01/31/2025.
Claims 1-6, 8, 10-16 and 25-26 are being examined on the merits.
Claim Rejections - 35 USC § 103
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 1-3, 5-6, 8, 11-16 rejected under 35 U.S.C. 103 as being unpatentable over McNamara et. al. (US20110224299A1). This rejection is maintained with slight modifications due to arguments and amendments filed on 04/08/2026.
McNamara’s general disclosure is to stabilized wax compositions (see abstract).
Regarding claim 1, McNamara teaches of compositions which comprise of two waxes having different melting points. McNamara teaches, (i) at least 25% by weight of a first wax component capable of melting on contact with human skin and (ii) a second wax component having a melting point greater than about 50° C. in an amount sufficient to stabilize said first wax such that said composition exists as a self-supporting solid or semi-solid at 30° C. (see claim 1). McNamara teaches “Low melt materials used in the various embodiments of the instant invention are generally stabilized by combination with a high melt wax.” (see 0029).
McNamara also teaches many suitable low melt waxes are emollients and therefore are useful as skin moisturizers (see 0025) and teaches that compositions of the present invention may include one or more additional emollients (see 0058). McNamara teaches the formulation as a lip balm or solid stick balm (see 0012, 0056) and teaches the composition may include soothing agents (see 0058).
Regarding claims 2-3, McNamara teaches using rice bran wax (see 0032, table 2).
Regarding claims 5 and 8, McNamara teaches using cocoa butter as a low melt wax with a melting point 31-35° C. (see 0028) and this would act as the emollient as claimed because McNamara also recognizes that low melt waxes are also emollients (see 0025). With the broadest reasonable interpretation, cocoa butter is considered a botanical butter.
Regarding claim 11, McNamara teaches using menthol to create a cooling sensation (see 0060-0061).
Regarding the limitations wherein the composition has a specific penetration value, McNamara teaches how to stabilize and control the consistency of the composition. For instance, McNamara teaches wherein “low melt materials used in the various embodiments of the instant invention are generally stabilized by combination with a high melt wax component. “Stabilized,” and related terms such as “stable,” “stability,” “stabilized,” “heat-stabilized,” and the like, refer to the ability of compositions comprising low melt materials to remain as self-supporting solids or semi-solids at room temperature and elevated temperatures (e.g., ˜40° C., ˜45° C., ˜50° C., etc.) while maintaining their integrity; and/or the ability of product forms comprising the compositions to regain their form (size, shape, texture, etc) and desired properties after exposure to elevated temperatures. “Stability” also refers to having a hardness sufficient for forming self-supporting forms, such as sticks and the like. “Elevated temperatures” refers herein to temperatures of about 40° C., about 45° C., about 47° C., about 49° C., about 50° C., or about 53° C. Preferably, stability can be maintained at elevated temperatures without material softening so as to not be self-supporting for extended periods of time, such as, e.g., a few minutes, an hour, preferably a few hours, more preferably a day, a few days, and still more preferably a week, a few weeks, a few months, or more, including for an indefinite period of time.
In some embodiments, the compositions comprise at least one low melt wax and a small proportion of at least one high melt wax, by which is meant below 40% by weight. A high melt wax refers to one having a higher melting point than that of a low melt material, typically at least 10° C. higher, at least 15° C. higher, at least 20° C. higher, or at least 25° C. higher, and preferably a melting point that is at least about 50° C. More preferably the melting point of the high melt wax is at least about 55° C., at least about 60° C., at least about 65° C., at least about 70° C. at least about 75° C., at least about 80° C., at least about 85° C., at least about 90° C., at least about 95° C., at least about 100° C., or higher. High melt waxes also typically, though not necessarily, have a softening point between about 50° C. and 90° C. One of skill in the art will recognize that high melt waxes are generally hydrophobic, and not considered water-soluble materials.” (see 0029-0030).
McNamara also teaches “a material's melting point, enthalpy of fusion, and melting temperature range can vary depending on the purity of the material. For example, such parameters can be used in purity determinations” (see 0024).
McNamara also teaches “when a low melt wax, for example having melting point slightly less than that of human skin, is applied to the skin, the wax melts absorbing heat from the skin. The absorption of heat can translate to a cooling sensation on the external surface of the skin.” “Without wishing to be bound by theory, the effective amount of a low melt wax to produce a cooling sensation may depend on, for example, its enthalpy of fusion, melting temperature range, and/or purity, as described in more detail below.” (see 0039).
McNamara does not specifically teach the first and second waxes are both within the instantly claimed melting point ranges however McNamara teaches compositions comprising of a first wax being within the melting point of greater than 50° C. (which is within the instantly claimed range), and teaches wherein this wax is in amounts enough to stabilize the lower melting wax. McNamara also teaches of including emollients and teaches wherein lower melting waxes can be emollients.
McNamara does not teach the waxes are in a 1:1 ratio however McNamara teaches “without wishing to be bound by theory, it is believed that the combination of high melt wax with low melt wax allows for stabilization of the low melt material, while the use of a small amount of the high melt material compared to the low melt material allows for optimization of certain desirable properties of the low melt material. That is, using the proportions of low melt to high melt wax taught herein can produce synergistic combinations, such that only a small proportion of high melt wax, e.g., 5-30% by weight, 7.5-25% by weight, or 10-20% by weight based on the entire composition, or a weight ratio of low melt wax to high melt wax of greater than about 3:2, greater than about 2:1, greater than about 5:2, greater than about 3:1, or greater than about 4:1, can effectively impart stability to the composition” (see 0032).
Therefore, it would have been obvious to persons skilled in the art before the effective filing date to optimize the waxes and emollients to be within the instantly claimed ranges because McNamara teaches that higher melting waxes are used to stabilize the lower melting waxes. Lower melting waxes can also act as emollients and thus one would also optimize the amounts to control for a smoother skin feel. Additionally, McNamara teaches ratios directly outside of 1:1, and also teaches when combining high melt and low melt materials that one needs to optimize for certain desirable properties. It is prima facie obvious to optimize directly outside of known parameters. Furthermore as discussed in MPEP section 2144.05(II)(A), “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).”
Furthermore, one would optimize the amount of low melt wax for creating varying cooling sensations as discussed by McNamara.
Selecting rice bran wax would have been a matter of judicious selection given the prior arts teachings.
It would have also been obvious to optimize the consistency of the waxes to create a composition within the claimed penetration values because McNamara teaches how to stabilize the composition using waxes with different melting points and teaches wherein the hardness is sufficient for forming self-supporting forms, such as sticks and the like. Thus one skilled in the art could optimize the consistency to create dome shaped balms as claimed. Also these parameters appear to be a mere matter of judicious selection which any person skilled in the art could optimize given the relied upon art. The applicant also recognizes that artisans can easily rely on the European Pharmacopoeia, for measurement of consistence by penetrometry, Ph. Eur. Edition 10, method 2.2.15. (see applicants own spec at page 9), in order to determine the penetrance values of the balm.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over McNamara et. al. (US20110224299A1) as applied to claims 1-3, 5-6, 8, 11-16 above, and further in view of Happi (www.happi.com/breaking-news/berry-good-news-from-kahlwax (2016)). This rejection is maintained with slight modifications due to arguments and amendments filed on 04/08/2026.
McNamara teaches the skin-care balm however is silent on wherein the second wax is rhus verniciflua peel cera.
Happi’s general disclosure is a web-based article about KahlWax (see article).
Happi teaches “Rhus Verniciflua Peel Cera. Berry Wax is harvested from the fruit of the “Rhus Verniciflua” tree, which is native to East Asia (China, Korea and Japan). The wax is extracted by boiling the skin of the fruit. Berry wax is a cream white coloured wax with a high chemical content of triglycerol ester of C16/18 Fatty Acid. According to the company, Berry Wax feels very silky and soft compared to classic emollient and melts at temperatures <30°C. In addition, Berry wax produces very smooth textures and improves significantly the sensory characteristics of O/W emulsions. Furthermore it is an excellent additive for oleogels, and is suitable for lip balms, body butters, and anhydrous sun care formulations. Melted in castor oil it forms a semi-transparent oleogel structure which can also be used as a base for weather protection or baby products. This combination is also available in a product called VegoJelly 7036PLUS.” (see first two para.).
Therefore it would have been obvious to persons skilled in the art before the effective filing date to use rhus verniciflua peel cera as the second wax in the formulation taught by McNamara because as Happi teaches it creates a very silky and soft feel and acts as an emollient which is suitable in balms and butters and can act as the lower melting wax because it has a melting point of less than 30°C.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over McNamara et. al. (US20110224299A1) as applied to claims 1-3, 5-6, 8, 11-16 above, and further in view of Rheins et. al. (WO2017091653A1). This rejection is maintained with slight modifications due to arguments and amendments filed on 04/08/2026.
McNamara teaches the skin-care balm however is silent on wherein the skin soothing agent is Zanthoxylum bungeanum fruit extract.
Rheins’ general disclosure is to lip protectant for cold sore sufferers (see abstract).
Rheins teaches using Zanthoxylum bungeanum fruit extract as a botanical anti-inflammatory extract (see claim 5 and 7) in formulations.
Therefore it would have been obvious to persons skilled in the art before the effective filing date to use Zanthoxylum bungeanum fruit extract in McNamara’s formulation in order to create a balm which has anti-inflammatory properties.
Claims 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over McNamara et. al. (US20110224299A1) as applied to claims 1-3, 5-6, 8, 11-16 above, and further in view of Keith Edgett and Louis DeFranco (US10342756B2) hereinafter Edgett. This rejection is maintained with slight modifications due to arguments and amendments filed on 04/08/2026.
McNamara teaches a skin-care balm as claimed however is silent on the ratio of low-melt wax to high-melt wax.
McNamara also teaches wherein the second wax has a melting point greater than about 60° C (see claim 6), greater than about 70° C. (see claim 7) and greater than about 80° C. (see claim 8).
McNamara teaches adding 25% by weight of low melt wax and teaches wherein the high melt wax wherein the melting point is above 70 or 80 degrees Celsius. This would create a combined wax with a melting point closer to 70 or 80 degrees as there is more of the high melt wax in the composition.
Edgett’s general disclosure is to hydrating lip balm compositions (see abstract).
Edgett teaches “by using low-melt waxes, the present invention is able to provide non-waxy and non-greasy protection to external tissues, while delivering significant emolliency and improved moisture to remediate dry, chapped, or irritated skin” (see detailed description, first para.).
Edgett teaches lip and skin tissue balms comprising of a first low-melt wax, a second low-melt wax and a high-melt wax and teaches wherein the high melt wax has a melting temperature of greater than about 50° C. and is present in an amount of about 18.6% to about 27.0% by weight (see claim 1). Edgett also teaches the low-melt wax is present in an amount of about 15% to about 45% (see claim 3).
Edgett teaches the wherein the ratio of the first and second low-melt waxes to the high-melt wax is about 1:1 (see claim 1).
Regarding claim 25, Edgett teaches including Murmuru butter at 5% (see table 3) which is directly outside the instantly taught range of 6% and teaches using Rhus Vernicflua peel cera (see table 5).
Therefore it would have been obvious to persons skilled in the art before the effective filing date to combine a low-melt wax and high-melt wax in a 1:1 ratio because Edggett teaches balm compositions which include the same ratio as instantly being claimed for controlling of the consistency of the product as one does not want to create a product that is either too stiff or too greasy (see background para.). Including botanical butters at the instantly claimed range is also prima facie obvious as Edgett teaches doing so at directly outside the claimed range. Controlling for the balms melting point is obvious given the prior art. It is known in the art to control for the melting point for consistency of the product and this is a matter of judicious selection and an optimization any person having ordinary skill in the art could do without any undue experimentation.
McNamara teaches adding 25% by weight of low melt wax and teaches wherein the high melt wax wherein the melting point is above 70 or 80 degrees Celsius. This would create a combined wax with a melting point closer to 70 or 80 degrees as there is more of the high melt wax in the composition.
Response to Arguments
Applicant's arguments filed 04/08/2026 have been fully considered but they are not persuasive. The applicant argues that the relied upon art, specifically McNamara does not teach wherein the first wax to second wax is in a 1:1 ratio. The applicant argues McNamara instead teaches away from a 1:1 ratio because McNamar describes using the high melt wax to stabilize the low melt wax in ratios wherein the low melt to high melt is about 3:2 or 2:1. These ratios are directly outside of 1:1 and McNamar teaches wherein the high melt wax is used to stabilize the low melt wax and specifically teaches that these are optimizable parameters as can be appreciated by paragraph 0032. McNamar discusses wherein “while the use of a small amount of the high melt material compared to the low melt material allows for optimization of certain desirable properties of the low melt material. That is, using the proportions of low melt to high melt wax taught herein can produce synergistic combinations, such that only a small proportion of high melt wax, e.g., 5-30% by weight, 7.5-25% by weight, or 10-20% by weight based on the entire composition, or a weight ratio of low melt wax to high melt wax of greater than about 3:2, greater than about 2:1, greater than about 5:2, greater than about 3:1, or greater than about 4:1, can effectively impart stability to the composition.” Here McNamara describes ratios directly outside of what is being claimed and discloses why one would optimize those amounts. In fact McNamara’s entire art teaches it is indeed the goal to stabilize the melting points of the low melt wax through combining it with different amounts (ranges) of high melt waxes. Optimizing these ratios to be directly outside of the prior arts already disclosed ranges is prima facie obvious. Additionally as discussed in MPEP section 2144.05(II)(A), “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).” In the instant case there is no patentable distinction from that of the prior arts teachings. It is obvious to person having ordinary skill in the art to optimize the amount of low melt wax to that of high melt wax for having a more stable product and/or to create products with different consistencies and textures. The low melt waxes are described as being emollients and are discussed as being able to cool the skin through its enthalpy of fusion and thus would be another reason to optimize the ratios.
The applicant argues that the Office has not addressed their argument that McNamara teaches away from optimizing the ratios of waxes to be at 1:1, however this is not the case as these optimizations are well within the purview of any skilled artisan and this ratio does not make a patentable distinction over the prior art because as discussed McNamara teaches ratios directly outside this range and teaches of reasons why one would optimize those ranges of waxes.
The applicant argues that Edgett teaches of low melt wax compositions and therefore would not teach a composition that would have a melting point of 70 to 90 degrees Celsius. McNamara teaches of including high melt waxes wherein their melting points are greater than 70 and 80 degrees Celsius and depending on the amount of high melt wax being included would create compositions with melting points in between these amounts being claimed. For instance, McNamara teaches adding 25% by weight of low melt wax and teaches wherein the high melt wax wherein the melting point is above 70 or 80 degrees Celsius. This would create a combined wax with a melting point closer to 70 or 80 degrees as there is more of the high melt wax in the composition.
Conclusion
Currently no claims are allowed.
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JACOB A BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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