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 . Claims 1-12 and 14-20 are pending; claims 1-12 and 14 are examined; and claims 15-20 are currently withdrawn in accordance with the election detailed in the Office action of 07/16/2025.
Applicant’s arguments, filed 03 June 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03 June 2026 has been entered.
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 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Webb et al. (US 2022/0054446, 02/24/2022, IDS reference) (hereinafter Webb) in view of Drennan (US 2022/0226241 A1, 07/21/2022).
Regarding claims 1 and 12, Webb discloses topicals including lotions, creams and salves comprising essential oils and oils of cannabinoids and terpenes ([0021]), including more than one of the various components ([0022]), derived from Cannabis plants including Cannabis sativa (i.e. hemp) ([0004]), a base cream ([0003]) that prevents separation of the components ([0022]), and magnesium chloride lotion. The magnesium chloride lotion is prepared by mixing magnesium chloride flakes with water and mixing by hand or mechanically until the components are fully incorporated into each other ([0023]). The terpenes may include limonene, which is a terpene found in abundance in many Cannabis strains and possesses antifungal and antibacterial properties ([0008]). The essential oils may include lavender essential oil and black pepper essential oil ([0015]). The CBD may be 3-7% (claim 9) by volume of the total composition ([0024]-[0025]); the magnesium chloride lotion may be 10-20% (claim 6); the base cream may be 65-95% (claim 4); the black pepper oil may be 0.2-2.10%; and the lavender essential oil may be 0.2-2.10% (claim 13). The topical may further comprise additional antiseptic or antifungal compounds or moisturizing or protective agent compound ([0025]).
Webb differs from the instant claim insofar as it does not explicitly disclose wherein the composition comprises an additional claimed species of cannabinoid or turmeric oil.
However, Drennan discloses cannabinoid oil-containing compositions as topical formulations (Abs) including balms, butters, or salves ([0091]), comprising cannabinoids including cannabidiol (CBD) and cannabidiviran (CBDV) ([0101]) and essential oils including turmeric oil ([0129]) having antioxidant properties ([0091]). The essential oils may each be about 0.1-10% by weight of the composition ([0131]).
Accordingly, it would have been obvious to one of ordinary skill in the art to have CBD and CBDV as the cannabinoids in the composition of Webb, since “it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose… [T]he idea of combining them flows logically from their having been individually taught in the prior art" as supported by MPEP § 2144.06(I).
Webb discloses wherein the salve comprises one or more essential oils. Accordingly, it would have been obvious to one of ordinary skill in the art to have formulated the topical salves of Webb with about 0.3-2.0% by weight of turmeric oil, since it is a known and effective essential oil suitable for cannabinoid-containing topical formulations as taught by Drennan. As such, the instantly claimed amounts (i.e. instant claim 10) would have been obvious.
Regarding claim 1 reciting a “broad-spectrum, concentrated” hemp oil, as noted by para. [0020] of the instant Specification, hemp oil contains cannabinoids with or without terpenes. The hemp oil may be concentrated by extraction with a heat source and solvent, resulting in a higher amount of CBD in the resulting hemp oil. The hemp oil may be broad spectrum, meaning there are multiple terpenes and multiple cannabinoids present in the hemp oil. Thus, under the broadest reasonable interpretation, the Examiner has interpreted ”broad-spectrum, concentrated hemp oil” as comprising multiple cannabinoids and terpenes that were extracted from Cannabis plant. Accordingly, absent explicit recitation of additional components encompassed by the term “hemp oil,” the compositions of Webb, comprising one or more cannabinoids and terpenes obtained by extraction from Cannabis plant, appear to meet the limitations of a “broad-spectrum” (i.e. containing more than one cannabinoids and terpenes), “concentrated” (i.e. extracted) hemp oil (i.e. extracted from Cannabis plant) as instantly claimed, consistent with the instant Specification.
Regarding the claimed magnesium oil, according to paragraph [0009] of the instant Specification, magnesium oil is made by processing magnesium chloride flakes with water. As discussed above, Webb discloses wherein the magnesium chloride lotion is prepared by mixing magnesium chloride flakes with water. Accordingly, the magnesium chloride lotion of Webb meets the limitation of magnesium oil as claimed.
Regarding the claimed natural preservative, since Webb discloses wherein limonene is found in many strains of Cannabis (i.e. natural) and possesses antibacterial and antifungal properties, it would be capable of preserving the topical salve. Thus, limonene would meet the limitation as a natural preservative.
Regarding the claimed amounts of various components, the claimed ranges (i.e. about 5-20% vol. of hemp oil (claim 2); about 5-40% vol. of magnesium oil (claim 3); about 60-80% vol. of carrier oil (claim 4); about 0.5-3% or 0.5-2% vol. of black pepper oil (claims 7 and 8); or about 2-10% vol. of one or more essential oil (claim 11)) would have been obvious to one of ordinary skill in the art since they overlap with the ranges of the prior art (i.e. 3-7% vol CBD, 10-20% magnesium chloride lotion; 65-95% of base cream; 0.2-2.10% of black pepper oil; and 0.2-2.10% of lavender essential oil). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I).
Regarding claims 5 and 6, Webb differs from the instant claim insofar as not explicitly disclosing wherein the base cream comprises beeswax.
However, Drennan further discloses wherein the topical formulation may be made utilizing the base ingredients of natural butters and herbal and/or vegetable/nut/seed oils including beeswax, shea butter, cocoa butter, and jojoba oil ([0090]-[0091]).
Accordingly, it would have been obvious to one of ordinary skill in the art to have included base ingredients such as shea nut butter and beeswax in the topical compositions of Webb, since each is a known and effective base suitable for topical formulations as taught by Drennan. See MPEP § 2144.06(I).
Response to Arguments
Applicant mainly asserts Webb teaches away from using a broad-spectrum Cannabis extract comprising multiple cannabinoids and multiple terpenes as claimed by the Applicant, referring to para. 0020 and 0021 of Webb, on pp. 7-8 of the Remarks dated 03 June 2026.
The Examiner does not find the assertion to be persuasive. The Examiner does not rely on the specific embodiment outlined in para. 0020, lines 23-30 of Webb, and Webb does not teach away from a “broad spectrum Cannabis extract comprising multiple cannabinoids and terpenes.” The fact that Webb discloses alternative sources of obtaining the cannabinoids and terpenes in additional to Cannabis plant does not render cannabinoids and terpenes extracted from Cannabis plant less obvious as a choice of source. See MPEP 2123(II). As highlighted by the Applicant, Webb discloses in para. 0021 that “isolated” should not be interpreted as restricting the meaning to pure isolates, or to restrict the method used to produce the isolation, such as extraction and distillation. Webb further discloses in the same paragraph wherein isolated cannabinoids and terpenes may be derived from the Cannabis plant. Thus Webb does not preclude other embodiments.
Moreover, it is not clear to the Examiner what is meant to be encompassed by the recitation of a “broad-spectrum, concentrated hemp oil.” As noted by para. [0020] of the instant Specification, hemp oil contains cannabinoids with or without terror. The hemp oil may be “concentrated” by extraction with a heat source and solvent, resulting in a higher amount of CBD in the resulting hemp oil. The hemp oil may be “broad spectrum,” meaning there are multiple terpenes and multiple cannabinoids present in the hemp oil. Thus, under the broadest reasonable interpretation, the Examiner has interpreted ”broad-spectrum, concentrated hemp oil” as comprising multiple cannabinoids and terpenes that were extracted from Cannabis plant. Accordingly, absent explicit recitation of additional components encompassed by the term “hemp oil,” the compositions of Webb, comprising one or more cannabinoids and terpenes obtained by extraction from Cannabis plant, reasonably appear to meet the limitations of a “broad-spectrum” (i.e. containing more than one cannabinoids and terpenes), “concentrated” (i.e. extracted) hemp oil (i.e. extracted from Cannabis plant) as instantly claimed, consistent with the instant Specification. As such, Applicant’s assertion is unpersuasive.
Applicant mainly asserts on pages 8-9 of the Remarks that Webb encompasses hundreds of different cannabinoids, whereas Applicant has found that certain cannabinoid compounds, as demonstrated in Examples 1-3 (Tables 1-3) of the instant Specification, are particularly effective for treating certain ailments as described at para. 0035 of the instant Specification. Webb does not provide any guidance as to which cannabinoids would be effective in Applicant’s specific formulation for treating such ailments.
The Examiner does not find the assertion persuasive. The fact that Webb discloses a multitude of effective combinations does not render any particular formulation less obvious. Regarding the additional species of cannabinoids disclosed by Webb, the comprehensiveness of the listing did not negate the fact that a claimed compound was specifically taught, since each compound is “described” by Webb. See MPEP § 2131.02(II). Moreover, para. 0035 of the instant Specification appears to be directed to a method of reducing or treating pain or inflammation and comprises steps of applying the CBD mineral salve. Examples 1-3 disclose an exemplary formulation of a CBD mineral salve, and two additional exemplary hemp oil profiles. Accordingly, it is not clear to the Examiner how para. 0035 and Examples 1-3 support Applicant’s assertion of particular effectiveness of the particular combination discovered by the Applicant in treating certain ailments. Applicant is encouraged to provide objective evidence showing the effectiveness in treatment utilizing the specifically claimed cannabinoids in comparison to other cannabinoids. It is further noted that Example 1 comprises specific compounds in specific amounts, described at paras. [0048-0051] of the instant Specification, and, purely arguendo, even if Applicant were to show unexpected results of statistical and practical significance, they would have been obtained, for example, with a specific combination of specific ratios and amounts of specific compounds, and not with “at least one carrier oil,” “a natural preservative,” or “one or more essential oils” generally. Applicant would have to explain how these specific species and amounts are “reasonably representative” of the much more broadly claimed subject matter of the claims. See MPEP §§ 716.01(c)(ii); 716.02, especially 716.02(b)(II) and 716.02(d); and 2145.
Applicant mainly asserts there is no disclosure or suggestion in Drennan for a composition comprising turmeric oil with cannabinoids and magnesium in a topical cream. Applicant discovered that including turmeric oil amplifies the anti-inflammatory action of the salve, working along different biological pathways.
The Examiner appreciates the explanation but does not find the assertion persuasive. As this is a 103 obviousness rejection, no one piece of prior art is required to teach each and every claim limitation. As discussed in the rejection, Webb discloses a composition comprising a broad-spectrum concentrated hemp oil and magnesium oil, and Drennan teaches one or more essential oils including turmeric oil, suitable for cannabinoid-containing topical formulations. Thus, Drennan provides the motivation to include turmeric oil. Regarding the alleged unexpected results, it is unclear to the Examiner which example demonstrates said alleged synergistic effects. Applicant is encouraged to explain with objective evidence supporting the allegation of unexpected synergy.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Webb et al. (US 2022/0054446, 02/24/2022, IDS reference) (hereinafter Webb) in view of Drennan (US 2022/0226241 A1, 07/21/2022, priority 06/10/2021) as applied to claims 1-12 above, further in view of Motahari (US 2023/0190620 A1, priority 12/16/2021).
Webb and Drennan have been discussed in detail above, and do not explicitly disclose a claimed natural preservative.
However, Motahari discloses natural preservatives useful in topical compositions, including Populus tremuloides bark extract ([0015]).
Accordingly, it would have been obvious to one of ordinary skill in the art to have included Populus tremuloides bark extract in the topicals of Webb, since it is a known and effective natural preservative or antiseptic suitable for topical compositions as taught by Motahari.
Response to Arguments
Applicant mainly asserts Motahari does not disclose using Phytocide elderberry extracts as preservatives, or a combination of plant-derived antimicrobials such as aspen bark, which contains natural salicylates, and fermented radish filtrate, which produces mild peptide antimicrobials. This combination keeps the product shelf-stable and skin-friendly. There is no suggestion or hint in the disclosures that such a natural preservative system is necessary or beneficial for a cannabinoid salve.
The Examiner appreciates Applicant’s explanation but does not find the assertion to be persuasive. As this is a 103 obviousness rejection, no one piece of prior art is required to teach each and every claim limitation. Therefore, it is not necessary for Motahari to disclose all of the components as instantly claimed. Moreover, claim 14 is not limited to Phytocide elderberry extract as preservatives. Therefore, it is not necessary for Motahari to disclose using Phytocide elderberry extracts as preservatives. Additionally, it is noted that the features upon which applicant relies (i.e., shelf-stability or a combination of aspen bark and fermented radish filtrate) are not required in the rejected claim. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Regarding the alleged unexpected benefit, Applicant does not appear to have discussed, in specific detail, objective data supporting increased results on shelf stability parameters. As such, the assertion is unpersuasive. Clarification is kindly requested.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Drennan (US 2022/0226241 A1, 07/21/2022) in view of Webb et al. (US 2022/0054446, 02/24/2022, IDS reference) (hereinafter Webb).
Drennan discloses stable cannabinoid oil-containing compositions as topical formulations (Abs) including balms, creams, and salves ([0081]). The compositions may comprise cannabinoids and terpenes, provided as Cannabis extracts ([0108]) from sources including hemp ([0117]). Exemplary cannabinoids include cannabidiol (CBD) and cannabidivarin (CBDV) ([0101]). Exemplary terpenes include caryophyllene, linalool, and myrcene ([0126]). The compositions may comprise carrier oils including hemp oil in amounts ranging from about 0.5% to about 99.5% w/w, and may include olive oil ([0135-0136]). The formulations further comprise essential oils or essential oil compounds including black pepper oil, lavender oil, and turmeric oil ([0129]). The composition may comprise about 0.1-10% by weight of each essential oil ([0131]). When formulated as a salve, the formulation may further comprise beeswax ([0091]). The compositions may comprise additional active or passive agents, including a preservative, and pharmaceutical excipients and other additives ([0154]). The compositions may be used to reduce symptoms of muscle cramping ([0197]).
Drennan differs from the instant claims insofar as not explicitly disclosing wherein the composition comprises magnesium chloride.
However, Webb discloses topicals including creams and salves, comprising essential oils and oils of cannabinoids and terpenes ([0021]) including CBD, black pepper essential oil, lavender essential oil, and magnesium chloride lotion for treating leg cramp pain. The magnesium chloride lotion is prepared by mixing magnesium chloride flakes with water, for example, in a 1:1 volume ratio, and mixing by hand or mechanically until the components are fully incorporated into each other ([0023]). The magnesium chloride lotion may be included in amounts of 10-20% by volume of the topicals (claim 6). The topicals may further comprise additional antiseptic or antifungal compounds ([0025]).
Accordingly, it would have been obvious to one of ordinary skill in the art to have included a magnesium chloride lotion in the composition of Drennan since it is a known and effective ingredient compatible with cannabinoids and terpenes and suitable for topical compositions treating cramp symptoms as taught by Webb. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP § 2144.07.
Regarding the instantly claimed magnesium oil, according to paragraph [0009] of the instant Specification, magnesium oil is made by processing magnesium chloride flakes with water. As discussed above, Webb discloses wherein the magnesium chloride lotion is prepared by mixing magnesium chloride flakes with water. Accordingly, the magnesium chloride lotion of Webb meets the limitation of magnesium oil as instantly claimed.
Regarding the claimed mean particle size and uniformly suspended within the carrier oil, as noted by para. [0014] of the instant Specification, the magnesium oil is made from a mixture of magnesium chloride flakes and water. “When these two substances are combined, the resulting liquid has an oily feel, but isn’t technically an oil.” Moreover, para. [0017] further notes that to create the desired texture and suspension, the magnesium oil, which is water-based, may be made from magnesium chloride flakes, by mixing in about a 2:1 to about a 1:2 ratio, or in about a 1:1 ratio, to dissolve the magnesium chloride flakes. The mixture may be agitated by any means until the flakes are dissolved to provide the magnesium oil. Since Webb utilizes substantially the same process to prepare said magnesium chloride lotion, specifically mixing magnesium chloride flakes and warm filtered water at a 1:1 ratio until fully incorporated (Webb: [0023]). Thus, one of ordinary skill in the art would reasonably conclude that the magnesium chloride lotion of Webb would possess substantially the same properties as the claimed magnesium oil, such as a mean particle size of about 500 µm to about 800 µm, and be uniformly suspended within the carrier oil like the claimed invention.
Regarding claim 2, Drennan further discloses wherein carrier oils, including hemp oil, may be from about 0.5% to about 99.5% w/w ([0136]). Accordingly, it would have been obvious to one of ordinary skill in the art to have selected an amount of hemp oil from the disclosed range of about 0.5-99.5% by weight, which appears to overlap the instantly claimed amounts in volume. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I). Moreover, in any case, the selection of appropriate volume percentages would appear to require no more than routine testing on the part of the skilled artisan, and so alternatively it would have been obvious to determine workable ranges to arrive at the claimed amounts in % by volume. "[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." See MPEP § 2144.05(II)(A).
Regarding claim 3, Drennan differs from the instant claim insofar as not explicitly disclosing an amount of magnesium chloride lotion. However, as discussed above, Webb discloses wherein the magnesium chloride lotion may be included at 10-20% by volume of the topicals. Accordingly, it would have been obvious to one of ordinary skill in the art to have included the magnesium lotion in amounts of 10-20% by volume of composition, since it is a known and effective amount suitable for cannabinoid-containing topical formulations as taught by Webb.
Regarding claim 4, Drennan further discloses wherein the carrier oils may be included in amounts ranging from about 0.5% to about 99.5% w/w ([0136]). Accordingly, it would have been obvious to one of ordinary skill in the art to have selected an amount of carrier oils from the disclosed range of about 0.5-99.5% by weight, which appears to overlap the instantly claimed amounts in volume. See MPEP § 2144.05(I). Moreover, in any case, the selection of appropriate volume percentages would appear to require no more than routine testing on the part of the skilled artisan, and so alternatively it would have been obvious to determine workable ranges to arrive at the claimed amounts in % by volume. See MPEP § 2144.05(II)(A).
Regarding claim 5, Drennan further discloses wherein the carrier oils may include olive oil ([0135]).
Regarding claim 6, Drennan further discloses that the formulation may further comprise beeswax ([0091]). Accordingly, it would have been obvious to one of ordinary skill in the art to have included olive oil and beeswax since each is a known and effective ingredient as taught by Drennan.
Regarding claims 7 and 8, Drennan further discloses wherein the composition may comprise about 0.1-10% by weight of each essential oil ([0131]). Accordingly, it would have been obvious to one of ordinary skill in the art to have selected an amount of black pepper oil from the disclosed range of 0.1-10% by weight, which appears to overlap the instantly claimed amounts in volume. See MPEP § 2144.05(I). Moreover, in any case, the selection of appropriate volume percentages would appear to require no more than routine testing on the part of the skilled artisan, and so alternatively it would have been obvious to determine workable ranges to arrive at the claimed amounts in % by volume. See MPEP § 2144.05(II)(A).
Regarding claims 9 and 10, Drennan discloses turmeric oil as an essential oil. Therefore, claims 9 and 10 are rejected based on same reasons set forth above in rejecting claims 7 and 8 as applied to turmeric oil.
Regarding claim 11, it would have been obvious to one of ordinary skill in the art to have selected amounts of essential oils from the disclosed range of 0.1-10% by weight each, which appears to overlap the instantly claimed amounts in volume. See MPEP § 2144.05(I). Moreover, in any case, the selection of appropriate volume percentages would appear to require no more than routine testing on the part of the skilled artisan, and so alternatively it would have been obvious to determine workable ranges to arrive at the claimed amounts in volume. See MPEP § 2144.05(II)(A).
Regarding claim 12, Drennan further discloses wherein the essential oils or essential oil compounds including lavender oil ([0129]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Drennan (US 2022/0226241 A1, 07/21/2022, priority 06/10/2021) in view of Webb et al. (US 2022/0054446, 02/24/2022, IDS reference) (hereinafter Webb) as applied to claims 1-12 above, further in view of Motahari (US 2023/0190620 A1, priority 12/16/2021).
Drennan and Webb have been discussed in detail above and differ from the instant claim insofar as not explicitly disclosing wherein the preservative comprises Populus tremuloides bark extract.
However, Motahari discloses preservatives useful in topical compositions, including Populus tremuloides bark extract ([0015]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP § 2144.07. Accordingly, it would have been obvious to one of ordinary skill in the art to have included Populus tremuloides bark extract in the compositions of Drennan, since it is a known and effective preservative or antiseptic suitable for topical compositions as taught by Motahari.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUCY TIEN whose telephone number is (571)272-8267. The examiner can normally be reached Monday - Thursday 8:30 AM - 6:30 PM EST.
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/LUCY M TIEN/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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