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 .
Status of Claims
Pursuant to the amendment filed on May 14, 2026, claims 1, 17 and 18 have been cancelled. Claims 2-16 and 19-23 have been amended. New claims 24 and 25 have been added.
Claims 2-16 and 19-25 are pending.
Terminal Disclaimer
The two terminal disclaimers filed on May 6, 2026 have been acknowledged and approved for copending applications 18/128,816 and 18/228,881.
Priority
This application claims priority to US Provisional Application 63/423,968 filed on 9 November 2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6 December 2023; 31 January 2024; 11 September 2024; 30 October 2024 are acknowledged and have been considered.
Response to Arguments
The amendment filed on May 14, 2026 has been entered and fully considered.
With respect to the Specification, the drawing has been omitted from the specification and the graph has been updated so that the data points are discernible from one another. The objection to the specification is hereby withdrawn.
With respect to the claim objections, the amendment of claim 16 and cancellation of claims 17-18 are enough to overcome the objections and are hereby withdrawn.
With respect to the rejection under 35 U.S.C. 112(b), the cancellation of claims 1 and 17-18, and the amendment of claim 15 are enough to overcome the rejection and is hereby withdrawn.
With respect to the rejection under 35 U.S.C. 102(a)(1), the cancellation of claim 1 and amendment of claim 2 to include the transition phrase “consisting essentially of” is enough to overcome the rejection and is hereby withdrawn.
With respect to the rejection under 35 U.S.C. 103, the amendment of claim 2 to recite the transition phrase “consisting essentially of” is sufficient to overcome the current rejection as Applicant’s assertion that US20190247299 (“Cameron”) does not teach a composition “consisting essentially of” plant oils, namely meadowfoam seed oil and squalane is persuasive. However, the amendment to claim 2 namely recitation of the plant oils "consist essentially of meadowfoam seed oil and squalane" (Remarks, p. 9), narrows the scope of the claim and therefore is an amendment that may necessitate a new ground of rejection.
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.
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.
Claims 2-16, 19-20, and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over WO2021092340 (“Chan”) in view of US Patent No. 6,136,330 (“Soliman”).
Chan teaches compositions containing squalane or mixtures of squalane and hemisqualane and that the compositions may serve as the base for the preparation of various cosmetics of various pharmaceuticals (Abstract). The composition taught contains a carrier and one or more cannabinoids, wherein the carrier contains squalene (p. 2, 2nd indented ¶). The squalane is in the amount from 10% w/w to 99.9% w/w of the composition and the cannabinoids are selected from the group consisting of cannabidiol (CBD), tetrahydrocannabinol (THC), etc. (p. 2, 4th indented ¶). Chan also teaches a cosmetic containing a carrier and a cannabinoid wherein the carrier is squalane and the cosmetic also contains one or more excipient selected from natural oil, synthetic oils, emulsifiers, emollients, moisturizers, etc. (p. 2, 5th indented ¶). Chan states: “However, one skilled in the art will readily appreciate, embodiments of the cosmetic of the invention may include other carriers or vehicles (hereinafter "cosmetic base(s)") in addition to squalane or squalane/hemisqualane.” The additional carrier may be an oleaginous base and can include C11-40 carboxylic acid in an amount from 0.1% to 20% (p. 12, 3rd and 5th indented ¶¶). The composition can also include vitamins like vitamin C, E, etc. (p. 15, 1st indented ¶). Based on Example 1, 1% CBD in squalane (Neossance Squalane) led to marked penetration and delivery of CBD into the skin cells of the in vitro model over a 24-hour time period (pp. 17-19). Table 7 shows comparisons between 1% CBD in squalane, sunflower oil, hemp seed oil, and caprylic/capric triglyceride, wherein the results demonstrate that squalane has the heightened ability to deliver cannabinoid to skin compared to other known carrier oils (p. 22).
Chan does not explicitly teach meadowfoam seed oil as an additional excipient in the composition.
Soliman teaches deposition of vitamins, such as vitamins A, C, and E and precursors of the same vitamins can be substantially increased by the inclusion of meadowfoam oil or its derivatives within the composition (col. 1, lines 15-23). The deposition is through an emulsion and provides an additional skin feel benefit through the presence of the oily emollient in the composition (col. 1, lines 24-30). The meadowfoam seed oil is commonly found in its native state in Limnanthes Alba as triglyceride with fatty acids being a mix of alkenoic fatty acids, mostly C20., i.e., 5-eicosenoic acid, others being C21 i.e., 5,13-heneicosenoic acid while still others being a mix of C22, i.e., 5-docosenoic acid and C22, i.e. 13-docosenoic acid (col. 6, lines 24-32). Soliman also teaches that meadowfoam seed oil contains 60-65% of a twenty-carbon terminal mono-carboxy acid, 12-20% of a twenty-two carbon terminal mono carboxy acid, and 15-28% of a twenty two carbon terminal mono carboxy acid (col. 6, lines 38-49).
Chan and Soliman are considered analogous art to the claimed invention because they are in the same field of optimizing delivery of active ingredients in compositions. Therefore, it would have been prima facie obvious to a person having ordinary skill in the art (PHOSITA), before the effective filing date of the claimed invention, to modify the composition containing squalane and CBD in Chan to include meadowfoam seed oil taught by Soliman because meadowfoam seed oil contains fatty acids with carbon chains ranging from C20-22 and is also taught by Soliman to have enhanced deposition properties. Based on the teachings of Chan, the composition containing squalane and CBD can further include unsaturated carboxylic acids as an additional oleaginous ointment base wherein the acids are C11-40 in carbon length. The teachings of Chan further teach inclusion of vitamins in the composition, and based on the teachings of Soliman, a PHOSITA would have been motivated to use meadowfoam seed oil to enhance the deposition properties of similar vitamins taught, namely vitamins E and C (vide supra). Accordingly, claims 2, 14, and 24 are prima facie obvious.
Regarding claims 3-5, Chan teaches an additional carrier can contain a combination of C11-40 carboxylic acids in the range of 0.1% to 20% by weight of the composition (vide supra). Modifying the composition in Chan to include meadowfoam seed oil, based on the teachings of Soliman, is prima facie obvious as discussed above; the ranges claimed in Chan overlap with the ranges instantly claimed and therefore would have been prima facie obvious for a PHOSITA to arrive at those concentration ranges (MPEP §2144.05(I)).
Regarding claims 6-7, Chan teaches squalane can be present in the range of 10% to 99.9% by weight (vide supra). Modifying the composition in Chan to include meadowfoam seed oil, based on the teachings of Soliman, is prima facie obvious as discussed above; the ranges claimed in Chan overlap with the ranges instantly claimed and therefore would have been prima facie obvious for a PHOSITA to arrive at those concentration ranges (MPEP §2144.05(I)).
Regarding claims 8-9, Chan teaches squalene can be present in the range of 10% to 99.9% by weight of the composition (vide supra). While this range falls outside the ranges instantly claimed, can be arrived at through routine optimization because the amount of squalane is also based on the solubility of the CBD in the composition (p. 11, 2nd indented ¶, last two sentences). In other words, the squalane concentration is a result-effective variable and would have been increased or decreased by a PHOSITA based on how much CBD is solubilized. Therefore, the ranges instantly claimed would have been prima facie obvious to a PHOSITA to arrive at (MPEP §2144.05(II)(A)).
Regarding claims 10-12 and 15-16 Chan teaches one or more cannabinoids selected from CBD, THC, etc. are included in the composition (vide supra). The cannabinoids may present in the amount of 0.01% to 10% by weight of the composition. With respect to instant claim 16, Chan teaches that one or more cannabinoids, which includes both CBD and THC, can be present in the composition. Therefore, the range of CBD alone and/or the ranges of CBD and THC, overlap with the ranges instantly claimed and would have been prima facie obvious to a PHOSITA to arrive at those concentration ranges (MPEP §2144.05(I)).
Regarding claim 13, Chan teaches THC as one of the cannabinoids taught to be present in the composition. Modifying the composition in Chan to include meadowfoam seed oil, based on the teachings of Soliman, is prima facie obvious as discussed above, and including THC as the cannabinoid of choice, based on the teachings of Chan, would have been prima facie obvious.
Regarding claims 19-20, Chan teaches the cosmetic, i.e., any substance or mixture intended to be placed in contact with various external parts of a subject’s body (epidermis, hair systems, etc.) (p. 11, last indented ¶), may contain one or more excipients such as moisturizers, condition agents, preservatives, etc. (p. 12, 1st indented ¶).
Regarding claim 22, the recitation “antimicrobial composition” does not further limit the structural elements making up the composition because the same components are present as in claim 2. Furthermore, the intended result of the cannabinoids topically penetrating the skin does not provide further structural limitation to the claim (MPEP §2111.04). Thus, modification of the composition in Chan to include meadowfoam seed oil, based on the teachings of Soliman, as discussed above, would have been prima facie obvious to a PHOSITA.
Regarding claim 23, Chan teaches the cosmetic may be applied to the skin of a subject, i.e., human or a domestic animal (p. 4, 3rd indented ¶), in need of treatment (p. 16, 1st indented ¶). Example 1 of Chan teaches that squalane is more effective than other carrier oils at providing heightened ability to deliver CBD to the skin of a subject. The addition of an excipient is taught by Chan, which can include meadowfoam seed oil, as taught by Solomon, for the reasons discussed above. Thus, the claim is prima facie obvious.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Chan in view of Soliman, further in view of Sharon Laboratories webpage, https://www.specialchem.com/cosmetics/product/sharon-laboratories-beautyderm-k10 (accessed 13 January 2026) (last updated 19 July 2022) (“Sharon”).
The teachings of Chan and Soliman are discussed above and are incorporated by reference herein.
Regarding claim 21, Chan and Soliman do not teach a composition including a waterproof shield on skin.
Sharon product page teaches components cetearyl alcohol, cetearyl glucoside, and sorbitan olivate make up the emulsifier Beautyderm K10. (p. 1, [Description]). Beautyderm K10 is explicitly stated to “Exhibit moisturizing and water-resistant properties. Beautyderm K10 is used to formulate creams and milks.”
Chan, Soliman, and Sharon are considered analogous art to the claimed invention because they are in the same field of optimizing delivery of active ingredients in compositions. Therefore, it would have been prima facie obvious to a person having ordinary skill in the art (PHOSITA), before the effective filing date of the claimed invention, to modify the composition containing squalane and CBD in Chan to include meadowfoam seed oil, taught by Soliman, because meadowfoam seed oil contains fatty acids with carbon chains ranging from C20-22 and is also taught by Soliman to have enhanced deposition properties. The inclusion of another emulsifier, Beautyderm K10, would have been prima facie obvious to a PHOSITA to include, because Chan teaches the composition can include additional excipients like emulsifiers, natural oils, etc. (p. 12, 1st indented ¶). The addition of the components that make up Beautyderm K10 (vide supra) would have been prima facie obvious to include, because a PHOSITA would have been motivated to ensure the active ingredients remain for extended periods of time at the necessitated site of treatment for a presumed subject.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Chan in view of Soliman, further in view of US20190247299 (“Cameron”).
The teachings of Chan and Soliman are discussed above and are incorporated by reference herein.
Regarding claim 25, Chan and Soliman do not teach including antibiotics, antifungals, antiseptics, or analgesics to compositions.
Cameron teaches compositions comprising sunflower oil (a type of plant oil), coconut oil (a type of vegetable oil), and cannabidiol (a type of cannabinoid) (¶ [0008]) to treat various skin related diseases including eczema, pruritic, dry skin, etc. (Abstract). Specific embodiments are taught where the topical compositions consist of squalane and cannabidiol (Example 6, ¶ [0322]). Cameron also teaches that the composition may include other skin care agents like antifungals, lidocaine, etc. (¶ [0115]).
Chan, Soliman, and Cameron are considered analogous art to the claimed invention because they are in the same field of optimizing delivery of active ingredients in compositions. Therefore, it would have been prima facie obvious to a person having ordinary skill in the art (PHOSITA), before the effective filing date of the claimed invention, to modify the composition containing squalane and CBD in Chan to include meadowfoam seed oil, taught by Soliman, because meadowfoam seed oil contains fatty acids with carbon chains ranging from C20-22 and is also taught by Soliman to have enhanced deposition properties. A PHOSITA would have been motivated to add an analgesic, like lidocaine, because Chan teaches the composition can include additional excipients (vide supra) and that reducing pain is one of the uses of the composition (Abstract; p. 27, claim 26).
Conclusion
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 SAHIL CHANDER AGGARWAL whose telephone number is (571)272-7755. The examiner can normally be reached 7am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAHIL CHANDER AGGARWAL/Examiner, Art Unit 1623
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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