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 .
Detailed Action
Status of Application
1. Receipt of the Request for Continued Examination (RCE) under 37 C.F.R. 1.114, the Amendment and Applicants’ Arguments/Remarks, all filed 3 June 2026 are acknowledged.
Claims 1-6, 14, and 17 are currently pending. Claims 7-13, 15-16, and 18-19 have been cancelled. Claims 1 and 14 have been amended. Claims 1-6, 14, and 17 are examined on the merits within.
Continued Examination Under 37 C.F.R. 1.114
2. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3 June 2026 has been entered.
Withdrawn Rejections
3. Applicant’s arguments, filed 3 June 2026, with respect to 35 U.S.C. 102 Rejections have been fully considered and are persuasive. The 35 U.S.C. 102(a)(1) Rejections of claims 1, 6, and 8-18 have been withdrawn. The 35 U.S.C. 103 Rejections of claims 1-6 and 8-19 have been withdrawn in view of the claim amendments. However, upon further consideration, a new rejection is made in view of McElvany (U.S. Patent Application Publication No. 2018/0207213).
New Rejections
Claim Rejections – 35 U.S.C. 112(a) New Matter
4. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
5. Claims 1-6, 14, and 17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
6. Claim 1 recites “at least one essential oil”. The specification recites “For example, dispersants such as antioxidants, film forming agents, oils, essential oils, sunscreens, preserving agents, fragrances, flavorants, fillers, neutralizing agents, cosmetic and dermatological active agents such as, for example, emollients, moisturizers, vitamins, essential fatty acids, surfactants, and mixtures thereof can be added, by way of example. See paragraph [0060]. The specification also recites “Lavender and Tea Tree Oil” as essential oils in Example 1. However, this does not provide support for “at least one essential oil” which reads on values of one or more, up to infinity. Recitation of the presence of essential oils, or two specific essential oils, does not provide support for the entire range of at least one essential oil. This deficiency may be remedied by reciting “an essential oil in an amount of…”
Claim Rejections – 35 U.S.C. 103
7. 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.
8. Claim(s) 1-6, 14, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over McElvany (U.S. Patent Application Publication No. 2018/0207213) in view of Mainella (U.S. Patent Application Publication No. 2021/0378950).
McElvany teaches antiviral pharmaceutical compositions comprising one or more cannabinoid compounds in the form of lip balms, creams and ointments. See abstract. The topical composition may be prepared in a form of a stick. The composition may comprise an astringent, such as tea tree oil and vitamin E. See paragraph [0010]. The composition may comprise from 5% to 20% cannabinoids. See paragraph [0011]. The cannabinoid may be THC or cannabidiol (CBD). See paragraph [0017]. Acceptable carriers include beeswax and coconut oil. See paragraph [0023]. The formulations may comprise waxes, such as beeswax and hydrogenated coconut oil to provide a robust stick structure while being relatively inexpensive. See paragraph [0050]. The wax may be present from 50 to 95%. See paragraph [0051]. The optional oils and/or waxy compounds can constitute from 0.5% to 99.9% of the total weight of the composition. The amount of oil and/or wax depends on the actual form or physical state of the composition. See paragraph [0063]. Flavorings include vanilla in amounts of 0.1% to 5%. . See paragraph [0054]. Tea tree oil or other essential oils may be used, with up to 2% tea tree oil. See paragraph [0076].
Extraction processes capable of preparing substantially pure cannabinoid forms, or products enriched in essentially any cannabinoids or cannabinoid acids which occur naturally in plant material (including free cannabinoid forms of naturally occurring cannabinoid acids) are described in U.S. Pat. No. 8,846,409, which is incorporated herein by reference. See paragraph [0047]. The term “substantially” and its variations are defined as being largely but not necessarily wholly what is specified as understood by one of ordinary skill in the art, and refers to ranges within 10%, within 5%, within 1%, or within 0.5%. See paragraph [0027]. Thus substantially pure reads on purity of 90 to 99.5%.
McElvany does not teach 1 to 10% vitamin E.
Mainella teaches a topical composition comprising at least one cannabinoid and at least one pharmaceutically active component which reduces pain and inflammation beyond the benefits provided by the at least one cannabinoid alone. The topical composition can be in the form of a stick or rub. See abstract. Thickeners includes cocoa butter, bees wax, shea butter, vegan wax and wax. See paragraph [0024]. Thickeners may be present in amounts of 20 to 96%. See paragraph [0038]. The cannabinoid is present in an amount of 1 to 30%. See paragraph [0038]. The cannabinoid is in liquid or solid form and can be a cannabidiol oil. See claims 12-13. Examples 1 and 2 show that the formulation does not require/include water. The composition can comprise tea tree oil or lavender oil. See paragraph [0026]. Example 1 of the instant specification uses lavender and tea tree oil as essential oils. The composition may comprise eucalyptus oil, lavender oil, garlic extract, marigold extract, oregano extract, menthol, lavender, rose hip, rose petals, fennel, and tea leaves (i.e., perfume or flavorant). See claims 10 and 14. The composition comprises vitamin E. See paragraph [0026]. The active ingredient may be present in amounts of 0.1 to 45% by weight. See paragraph [0034]. The active ingredient includes Vitamin E. See paragraph [0026]. The composition is applied topically and provides pain relief. See paragraph [0045].
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to use 1 to 10% vitamin E in the formulation of McElvany because Mainella teaches this is a known effective amount used in combination with cannabidiol and waxes in a stick formulation, wherein the vitamin E provides additional therapeutic benefit. It would have been well within the purview of the skilled artisan to modify the amounts of coconut oil and beeswax because McElvany teaches the amount is dependent on the physical state and form of the formulation desired. It would have been obvious to substitute vanilla crème for vanilla to yield the same flavor while also optimizing the desired physical state and form. It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to use the stick made obvious by McElvany and Mainella in the treatment of pain because Mainella teaches the effectiveness of the same combination of ingredients in providing pain relief.
Correspondence
9. No claims are allowed at this time.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WORSHAM whose telephone number is (571)270-7434. The examiner can normally be reached Monday-Friday (8-5).
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/JESSICA WORSHAM/Primary Examiner, Art Unit 1615
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