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 .
Election/Restrictions
Applicant's election with traverse of Boswellia carteri (claim 7), emulsifying agents (claim 8), between 7.5x10-4 and 7% by weight of emulsifying agent (claims 9-10); salicylic acid (claim 11), coconut oil (claim 12), myristate esters (claim 13), medium chain triglycerides (claim 14), butylated hydroxytoluene (claim 15); benzyl alcohol (claim 18); and cannabidiol (claim 19) in the reply filed on 07/06/2026 is acknowledged. The traversal is on the ground(s) that no election of species are required to meet the standard for unity of invention. This is not found persuasive because the species recited in the Markush groups are not linked as to form a single general inventive concept under PCT Rule 13.1. For example, the Markush group in claim 7 lists a large variety of different herbal extracts, all of which has different sources, different structures, and potentially different mechanisms of action within a skin care formulation. Therefore, this Markush group does not form a single general inventive concept.
The requirement is still deemed proper and is therefore made FINAL.
Priority
The instant application filed on 12/20/2023 is a 371 of PCT/CA2022/051012 filed on 06/23/2022 and claims priority to provisional application 63/213,812 filed on 06/23/2021. PRO 63/213,812 finds support for the instantly claimed invention; therefore, the effective filing date of the instant application is 06/23/2021.
Information Disclosure Statement
No Information Disclosure Statement (IDS) has been filed in this Application. Applicant is reminded that each individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the U.S. Patent and Trademark Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability (see 37 C.F.R. § 1.56).
Claim Objections
Claim 1 is objected to because of the following informalities: “ahyaluornate” should be “a hyaluronate”. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: “1x104 % by weight” should be “1x10-4 % by weight”. Appropriate correction is required.
Claims 3 and 7 are objected to because of the following informalities: all Latin names (i.e., genus and species) should be italicized and the genus should be capitalized. Appropriate correction is required.
Claim 9 objected to because of the following informalities: “between 2x1 O5 and 5% by weight of antioxidant” should be “between 2x10-5 and 5% by weight of antioxidant”. Additionally, “between 5x10-3 and 15% by weight of stabilizer” should be “between 5x10-3 and 15% by weight of stabilizer”. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: “between 2x1O-5 and 1% by weight of antioxidant” should be “between 2x10-5 and 1% by weight of antioxidant”. Appropriate correction is required.
Claims 22 and 24 are objected to because of the following informalities: a-Linolenic acid” should be α-Linolenic acid. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b), Indefiniteness
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.
Claims 7 and 13 rejected under 35 U.S.C. 112(b) 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 7 recites “(e.g. b-caryophyllene)” in parentheses; however, it is unclear if what is in parentheses is part of the claimed invention or a preferred embodiment. Additionally, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For the purposes of applying prior art, the Examiner has interpreted what is recited in parentheses to be a preferred embodiment and not part of the instantly claimed invention.
Claim 13 recites “(Tricaprylin)” in parentheses; however, it is unclear if what is in parentheses is part of the claimed invention or a preferred embodiment. For the purposes of applying prior art, the Examiner has interpreted what is recited in parentheses to be a preferred embodiment and not part of the instantly claimed invention.
Claim Rejections - 35 USC § 102, Anticipation
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 8-9, 14, and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kuang (CN 112137922; Date of Publication: December 29, 2020).
Kuang’s general disclosure relates to “an industrial hemp leaf eye cream for removing dark circles, resisting allergy and diminishing inflammation, which comprises the following specific components in 100 parts by weight: 40-80% of water, 1-10% of glycerol, 1-10% of angelica sinensis extract, 1-10% of pseudo-ginseng extract and 0.05-3% of astragalus membranaceus extract” (see, e.g., Kuang, English Translation, Abstract).
Regarding claim 1 pertaining to the skin care formulation, Kuang teaches an eye cream composition comprising cannabidiol CBD, Opuntia dillenii stem extract, and 0.05-05% by weight of sodium hyaluronate (see, e.g., Kuang, English Translation, claims 1-2).
Regarding claim 2 pertaining to the skin care formulation, Kuang teaches Caprylic/capric triglyceride at 0.1-6% by weight, which acts as both a skin penetration enhancer and an oleaginous base (see, e.g., Kuang, English Translation, claim 1 & pg. 2, paragraph 3). Additionally, Kuang teaches cannabis leaf extract as an emollient (see, e.g., Kuang, English Translation, claim 1 & pg. 3, paragraph 2).
Regarding claim 3 pertaining to the herbal extract, Kuang teaches Opuntia dillenii stem extract (see, e.g., Kuang, English Translation, claim 1).
Regarding claim 8 pertaining to the emulsifier, Kuang teaches “the PPG-10 cetyl ether phosphate, di-C12-15 alkanol polyether-8 phosphate, C20-22 alcohol phosphate and acrylic acid/C12-22 alkanol methacrylate copolymer are taken as an emulsifier” (see, e.g., Kuang, English Translation, pg. 2).
Regarding claims 9-10 pertaining to the weight of the emulsifier in the skin care formulation, Kuang teaches PPG-10 cetyl ether phosphate 0.2-2%, Di C12-15 Alkanopolyether-8 phosphate 0.2-2%, C20-22 alcohol phosphate 0.5-3%, and Acrylic acid (ester)/C12-22 alkanol methacrylate copolymer 0.5-3% (see, e.g., Kuang, English Translation, claim 1).
Regarding claim 14 pertaining to the oleaginous base, Kuang teaches Caprylic/capric triglyceride within the composition (see, e.g., Kuang, English Translation, claim 1), which are medium chain triglycerides.
Regarding claim 18 pertaining to the solubilizing agent, Kuang teaches 0.1 to 1% of benzyl alcohol within the skin care composition (see, e.g., Kuang, English Translation, claim 1).
Regarding claims 19-20 pertaining to the cannabinoid, Kuang teaches that the eye cream composition comprises cannabidiol CBD (see, e.g., Kuang, English Translation, claim 2).
Claim Rejections - 35 USC § 103, Obviousness
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 4-6, 12, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Kuang as applied to claims 1-3, 8-9, 14, and 18-20 above, and further in view of Rawlings (U.S. Patent No. 5,439,935; Date of Publication: August 8, 1995).
Kuang’s general disclosure is discussed above.
However, Kuang does not teach: the skin care formulation comprising an extract from a papaya species (claim 4); or wherein the extract from the papaya species comprises one or more proteolytic enzymes (claim 5); or wherein the one or more proteolytic enzymes are one or both papain and bromelain (claim 6); or wherein the UV blocking agent is coconut oil (claim 12); or wherein the antioxidant is butylated hydroxytoluene (claim 15).
Rawling’s general disclosure relates to “A composition for topical application to the skin for alleviation or prevention of dry flaky skin conditions, dandruff or acne comprising: (1) a glycosidase; and (2) a protease the components (1) and (2) being present simultaneously in the composition or being separately presented with indication for the application of component (1) before component (2)” (see, e.g., Rawlings, abstract).
Regarding claims 4-6 pertaining to the proteolytic enzymes derived from a papaya species, Rawlings teaches the composition comprises proteases, such as bromelain and papain, which are derived from papaya (see, e.g., Rawlings, col 2, lines 8-19).
Regarding claim 12 pertaining to coconut oil, Rawlings teaches that coconut oil can be used in the composition (see, e.g., Rawlings, col 2, line 53).
Regarding claim 15 pertaining to butylated hydroxytoluene (BHT), Rawlings teaches butyl hydroxy toluene as an antioxidant (see, e.g., Rawlings, col 6, lines 66-67).
It would have been obvious to one of ordinary skill in the art before the effective filing date to produce Kuang’s eye cream composition, wherein the composition comprises proteases, such as bromelain and papain, as well as coconut oil and BHT, as taught by Rawlings. One would have been motivated to do so because Rawlings teaches that proteases, such as bromelain and papain, can be used within skin care formulations in order to alleviate or prevent dry flaky skin (see, e.g., Rawlings, abstract & col 1, lines 44-49). Additionally, Rawlings teaches coconut oil as an emollient (see, e.g., Rawlings, col 2, line 53) and BHT as an antioxidant (see, e.g., Rawlings, col 6, lines 66-67). Moreover, Kuang teaches a skin care formulation “for removing dark circles, resisting allergy and diminishing inflammation, which comprises the following specific components in 100 parts by weight: 40-80% of water, 1-10% of glycerol, 1-10% of angelica sinensis extract, 1-10% of pseudo-ginseng extract and 0.05-3% of astragalus membranaceus extract” (see, e.g., Kuang, English Translation, Abstract). Furthermore, Kuang teaches that sodium hyaluronate can be used within the skin care formulation in order to moisturize the skin and CBD can be used within the formulation as an emollient, which would further moisturize the skin (see, e.g., Kuang, English Translation, pg. 4). Kuang also teaches that CBD has anti-oxidation properties (see, e.g., Kuang, English Translation, pg. 4). Therefore, based on the teachings of Kuang and Rawlings, it would have been obvious to include bromelain and papain in a skin care composition because these proteases will alleviate or prevent dry flaky skin, while also providing moisturization via the coconut oil and anti-oxidative properties via BHT. One would have expected success because Kuang and Rawlings both teach production of skin care formulations.
Claims 7 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Kuang and Rawlings as applied to claims 1-6, 8-9, 12, 14-15, and 18-20 above, and further in view of Li (CN 105496994; Date of Publication: April 20, 2016).
The references of Kuang and Rawlings are discussed above.
However, the references not teach: wherein the skin care formulation comprises Boswellia carteri (frankincense) (claim 7); or wherein the antioxidant is one or more stilbene antioxidant derivatives (claim 16); or wherein the one or more stilbene antioxidant derivatives are one or both piceatannol and resveratrol (claim 17).
Li’s general disclosure relates to an external skin preparation comprising “components including a pseudo-ceramide compound, a steroid, fatty acid and N-acylethanolamine and contains no grease” (see, e.g., Li, English Translation, Abstract).
Regarding claim 7 pertaining to the composition additionally comprising frankincense, Li teaches that the skin care composition comprises Olibanum extract (see, e.g., Li, English translation, pg. 3, paragraph 4), which is also known as frankincense.
Regarding claims 16-17 pertaining to the antioxidant, Li teaches that the composition comprises resveratrol as an antioxidant (see, e.g., Li, English Translation, pg. 3, paragraph 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce Kuang and Rawlings eye cream composition, wherein the composition comprises frankincense and resveratrol, as taught by Li. One would have been motivated to do so because Li teaches that Olibanum extract, also known as frankincense, comprises anti-inflammatory activity and suppresses sebum (see, e.g., Li, English Translation, pg. 2). Additionally, Li teaches that resveratrol also is an anti-inflammatory that suppresses the production of sebum, but that also exhibits anti-oxidation function (see, e.g., Li, English Translation, pg. 2). Moreover, Kuang teaches an eye cream formulation that “comprises the following specific components in 100 parts by weight: 40-80% of water, 1-10% of glycerol, 1-10% of angelica sinensis extract, 1-10% of pseudo-ginseng extract and 0.05-3% of astragalus membranaceus extract” and wherein the formulation exhibits anti-allergic and anti-inflammatory properties (see, e.g., Kuang, English Translation, Abstract). Rawlings teaches “A composition for topical application to the skin for alleviation or prevention of dry flaky skin conditions, dandruff or acne comprising: (1) a glycosidase; and (2) a protease” (see, e.g., Rawlings, abstract), wherein the composition can include BHT as an antioxidant (see, e.g., Rawlings, col 6, lines 66-67). Therefore, based on the teachings of Kuang, Rawlings, and Li, it would have been obvious to include frankincense and resveratrol in the formulation in order to produce a skin care formulation that also exhibits anti-oxidative effects and suppresses sebum. One would have expected success because Kuang, Rawlings, and Li both teach skin care formulations that have anti-inflammatory properties.
Claims 11 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Kuang as applied to claims 1-3, 8-9, 14, and 18-20 above, and further in view of Ghalili (US 2017/0042791; Date of Publication: February 16, 2017).
Kuang’s general disclosure is discussed above.
However, Kuang does not teach: wherein the exfoliating agent is salicylic acid (claim 11); or wherein the cannabinoid is hemp oil (claim 21).
Ghalili’s general disclosure relates to “a topical composition for treating skin that comprises a therapeutically effective amount of at least one cannabinoid and a therapeutically effective amount of a hydroxy acid in a topically acceptable carrier” (see, e.g., Ghalili, [0008]).
Regarding claim 11 pertaining to salicylic acid, Ghalili teaches salicylic acid as the hydroxy acid in the composition (see, e.g., Ghalili, [0008]). Additionally, Ghalili teaches that salicylic acid is a beta hydroxy acid, which is lipid-soluble and acts as a chemical exfoliant (see, e.g., Ghalili, [0008] & [0028]-[0029]).
Regarding claim 21 pertaining to the cannabinoid, Ghalili teaches that the cannabinoid in the composition is hemp oil (see, e.g., Ghalili, [0009]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce Kuang’s eye cream composition, wherein the composition comprises salicylic acid, as taught by Ghalili. One would have been motivated to do so because Ghalili teaches that salicylic acid is a beta hydroxy acid, which is lipid-soluble and acts as a chemical exfoliant (see, e.g., Ghalili, [0008] & [0028]-[0029]). Moreover, Kuang teaches an eye cream formulation that “comprises the following specific components in 100 parts by weight: 40-80% of water, 1-10% of glycerol, 1-10% of angelica sinensis extract, 1-10% of pseudo-ginseng extract and 0.05-3% of astragalus membranaceus extract” and wherein the formulation exhibits anti-allergic and anti-inflammatory properties (see, e.g., Kuang, English Translation, Abstract). Therefore, based on the teachings of Kuang and Ghalili, it would be obvious to include salicylic acid in the skin care composition in order for the composition to provide exfoliant properties. One would have expected success because Kuang and Ghalili both teach skin care compositions comprising cannabidiol.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Kuang as applied to claims 1-3, 8-9, 14, and 18-20 above, and further in view of Bonina (US 2017/0100447; Date of Publication: April 13, 2017), Rousseau (WO 2021/087314; Date of Publication: May 5, 2021), Stinchcomb (US 2011/0052694; Date of Publication: March 3, 2011), Rawlings (U.S. Patent No. 5,439,935; Date of Publication: August 8, 1995 – cited above), and Morariu (US 2006/0216251; Date of Publication: September 28, 2006), as evidenced by Aremu (What are humectants, and what do they do?; 2022), Lauren (What is a wetting agent and where are they used?; 2025), and Cleveland Clinic (Emollients; 2022).
Kuang’s general disclosure is discussed above.
Regarding claim 22 pertaining to the skin care formulation, Kuang teaches an eye cream comprising 0.05-3% cannabidiol (see, e.g., Kuang, English Translation, Claim 1), 0.1 to 1% of benzyl alcohol (see, e.g., Kuang, English Translation, claim 1), 0.1-6% caprylic/capric triglycerides which are medium chain triglycerides (see, e.g., Kuang, English Translation, claim 1); and 40-80% water as the solvent (see, e.g., Kuang, English Translation, Claims 1-2).
However, Kuang does not teach: 2500 mg of opuntia fruit extract (claim 22); or 0.1 mg of hyaluronic acid (claim 22); or 0.75 mg of sorbitan monostearate (claim 22); or 3 mg of tween 60 (claim 22); or 6 mg of cetostearyl alcohol (claim 22); or 5 mg of propylene glycol (claim 22); or 0.14 mg of methyl paraben (claim 22); or 0.02 mg of butylated hydroxytolene (claim 22); or 2 mg of eicosapentaenoic acid (claim 22); or 2 mg of α-Linolenic acid (claim 22); or 5 mg of isopropyl myristate (claim 22).
Bonina’s general disclosure relates to “nutraceutical, cosmetic or pharmaceutical compositions based on a combination of vegetal extracts from flowers or fruits of Opuntia ficus and Oryza sativa (Black rice) for inhibition of the 5-alpha reductase” (see, e.g., Bonina, abstract). Moreover, Bonina, discloses extracts of Opuntia Ficus Indica flower and/or fruit has been studied in literature for its effects on acne and skin disorders (see, e.g., Bonina, [0016]).
Regarding claim 22 pertaining to Opuntia fruit extract, Bonina teaches cosmetic compositions comprising “an extract of flowers and/or fruits of Opuntia Ficus Indica” (see, e.g., Bonina, [0024]), wherein for topical administration the concentration range can vary between 0.5-5% (see, e.g., Bonina, [0029]).
Rousseau’s general disclosure relates to “A medicinal, cosmetic or dermatologic product is described made from a reconstituted cannabis material. The reconstituted cannabis material forms a sheet-like layer that can be shape configured to cover a portion of a user's body. The product can be used as a face mask, as a wound dressing, or the like” (see, e.g., Rousseau, abstract).
Regarding claim 22 pertaining to the skin care formulation, Rousseau teaches “One or both of the plant extract and the fibrous plant product may further comprise a matrix of a texturing agent, such as a non-crosslinked hydrocolloid polymer of natural or synthetic origin, preferably of natural origin”, wherein the texturing agent can be hyaluronic acid (see, e.g., Rousseau, [0088]). Additionally, Rousseau teaches that the composition can also comprise a humectant, wherein the humectant can be propylene glycol in an amount from about 2% to about 25% by weight (see, e.g., Rousseau, [0015]). Moreover, Rousseau teaches that another humectant that can be used within the composition is isopropyl myristate (see, e.g., Rousseau, [0079]), wherein “the humectant is present on the reconstituted plant material in an amount less than about 25% by weight, such as in an amount less than about 20% by weight, and generally in an amount less than about 15% by weight. The humectant may be present on the plant material in an amount greater than about 3% by weight, such as in an amount greater than about 5% by weight” (see, e.g., Rousseau, [0080]).
Stinchcomb’s general disclosure relates to “microneedle drug delivery systems comprising a pharmaceutical compositions comprising pharmaceutically active agents (e.g., cannabidiol and prodrugs of cannabidiol)” (see, e.g., Stinchcomb, abstract). Moreover, Stinchcomb discloses a pharmaceutical composition comprising a cannabinoid, wherein the pharmaceutical composition can be applied to the skin surface as a gel or hydrogel for treatment of diseases or disorders (see, e.g., Stinchcomb, [0003]-[0004]).
Regarding claim 22 pertaining to the skin care formulation, Stinchcomb teaches that the pharmaceutical composition can comprise a surfactant for use as a wetting agent, such as sorbitan monostearate, wherein the wetting agent can be in the amount of about 0.25% to 15% (see, e.g., Stinchcomb, [0111]). Stinchcomb teaches penetration enhancers, such as nonionic surfactants including tween 60, can be included in the composition (see, e.g., Stinchcomb, [0092]). Moreover, Stinchcomb teaches that the penetration enhancer can be present in the amount of about 0.1% to 95% (see, e.g., Stinchcomb, [0098]). Stinchcomb teaches that the pharmaceutical composition can comprise emollients, such as cetostearyl alcohol, in the amount by weight of about 1% to about 30% (see, e.g., Stinchcomb, [0114]). Stinchcomb teaches methyl paraben, which is an antimicrobial preservative, can be added to the pharmaceutical composition, wherein the antimicrobial preservative is present in the amount of about 0.1% to about 5% (see, e.g., Stinchcomb, [0116]).
Rawling’s general disclosure is discussed above.
Regarding claim 22 pertaining to butylated hydroxytoluene, Rawlings teaches butyl hydroxy toluene as an antioxidant at a percentage of 0.01% w/w (see, e.g., Rawlings, col 6, lines 66-67).
Morariu’s general disclosure relates to a skin care formulation comprising “a lipoic acid, a carnitine, and a carnosine in a suitable vehicle for topical application” (see, e.g., Morariu, abstract), wherein the skin care formulation is “useful in improving the appearance of aged skin characterized by wrinkles and loss of elasticity” (see, e.g., Morariu, abstract).
Regarding claim 22 pertaining to the skin care formulation, Morariu teaches that the skin care composition can comprise eicosapentaenoic acid, which has collagenase inhibitor activities (see, e.g., Morariu, [0086]). Morariu teaches that the skin care composition can comprise α-linolenic acid, which is an anti-inflammatory agent (see, e.g., Morariu, [0108]).
It would have been first obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce Kuang’s eye cream composition, wherein the composition further comprises Opuntia fruit extract, as taught by Bonina. One would have been motivated to do so because Bonina teaches that Opuntia ficus fruit extract inhibits 5-alpha reductase, which is beneficial in prevention or treatment of androgenic alopecia and acne (see, e.g., Bonina, abstract). Moreover, Kuang teaches an eye cream formulation that “comprises the following specific components in 100 parts by weight: 40-80% of water, 1-10% of glycerol, 1-10% of angelica sinensis extract, 1-10% of pseudo-ginseng extract and 0.05-3% of astragalus membranaceus extract” and wherein the formulation exhibits anti-allergic and anti-inflammatory properties (see, e.g., Kuang, English Translation, Abstract). Therefore, based on the teachings of Kuang and Bonina, it would have been obvious to include Opuntia ficus fruit extract within the skin care formulation in order to produce a composition that prevents or treats androgenic alopecia and acne, while also exhibiting anti-allergic and anti-inflammatory properties. One would have expected success because Kuang and Bonina both teach skin care formulations comprising extracts from different parts of Opuntia species.
It would have been secondly obvious to one of ordinary skill in the art to produce Kuang’s eye cream composition, wherein the composition further comprises hyaluronic acid, propylene glycol, and isopropyl myristate, as taught by Rousseau. One would have been motivated to do so because Rousseau teaches a skin care composition comprising cannabis (see, e.g., Rosseau, abstract). Rousseau teaches that hyaluronic acid is a texturing agent, such as “emulsifiers or stabilizers or phosphates or dough conditioners, can be used to add or modify the overall texture, color, or surface of products” (see, e.g., Rousseau, [0023]). Additionally, Rousseau teaches that propylene glycol and isopropyl myristate are humectants (see, e.g., Rousseau, [0011], [0079]), which is inherently a water-attracting substance that can relieve dry skin, reduce thickened skin, and strengthen the skin barrier (see, e.g., Aremu, Art of Record). Moreover, Kuang teaches an eye cream formulation that “comprises the following specific components in 100 parts by weight: 40-80% of water, 1-10% of glycerol, 1-10% of angelica sinensis extract, 1-10% of pseudo-ginseng extract and 0.05-3% of astragalus membranaceus extract” and wherein the formulation exhibits anti-allergic and anti-inflammatory properties (see, e.g., Kuang, English Translation, Abstract). Therefore, based on the teachings of Kuang and Rousseau, it would have been obvious to produce a skin care formulation hat comprises hyaluronic acid, propylene glycol, and isopropyl myristate because the hyaluronic acid would allow for one of ordinary skill in the art to modify the texture, color, or surface of the composition, while the propylene glycol and isopropyl myristate would increase the moisturizing capability of the formulation. One would have expected success because Kuang and Rousseau both teach skin care formulations comprising cannabidiol.
It would have been thirdly obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce Kuang’s eye cream composition, wherein the composition further comprises sorbitan monostearate, tween 60, cetostearyl alcohol, and methyl paraben, as taught by Stinchcomb. One would have been motivated to do so because Stinchcomb teaches a pharmaceutical composition comprising cannabidiol for the treatment of diseases and disorders (see, e.g., Stinchcomb, abstract). Furthermore, Stinchcomb teaches that sorbitan monostearate is a surfactant for use as a wetting agent (see, e.g., Stinchcomb, [0111]), wherein wetting agents, otherwise known as surfactants, inherently lower the surface tension of water allowing liquid to spread across solid surfaces evenly (see, e.g., Lauren, Art of Record). Additionally, Stinchcomb teaches tween 60 is a nonionic penetration enhancer, wherein “Nonionic surfactants enhance penetration in part by emulsifying the sebum and enhancing the thermodynamic activity or solubility of the active” (see, e.g., Stinchcomb, [0092]). Stinchcomb teaches that cetostearyl alcohol is and emollient (see, e.g., Stinchcomb, [0114]), wherein an emollient inherently softens and sooths skin, and contains ingredients such as creams, lotions, or ointments (see, e.g., Cleveland Clinic, Art of Record). Lastly, Stinchcomb teaches methyl paraben, which is an antimicrobial preservative, can be added to the pharmaceutical composition, (see, e.g., Stinchcomb, [0116]). Moreover, Kuang teaches “an industrial hemp leaf eye cream for removing dark circles, resisting allergy and diminishing inflammation” (see, e.g., Kuang, English Translation, Abstract). Therefore, based on the teachings of Kuang and Stinchcomb, it would have been obvious to produce a skin care formulation that comprises sorbitan monostearate, tween 60, cetostearyl alcohol, and methyl paraben. One would have expected success because Kuang and Stinchcomb both teach topical pharmaceutical compositions comprising cannabidiol.
It would have been fourthly obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce Kuang’s eye cream composition, wherein the composition further comprises butyl hydroxy toluene, as taught by Rawlings. One would have been motivated to do so because Rawlings teaches that butyl hydroxy toluene is an antioxidant (see, e.g., Rawlings, col 6, lines 66-67). Moreover, Kuang teaches “an industrial hemp leaf eye cream for removing dark circles, resisting allergy and diminishing inflammation” (see, e.g., Kuang, English Translation, Abstract). Therefore, based on the teachings of Kuang and Rawlings, it would have been obvious to produce a skin care formulation comprising butyl hydroxy toluene in order for the skin care composition to exhibit antioxidant properties. One would have expected success because Kuang and Rawlings both teach skin care compositions exhibiting antioxidant properties.
It would have been fifthly obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce Kuang’s eye cream composition, wherein the composition further comprises eicosapentaenoic acid and α-linolenic acid, as taught by Morariu. One would have been motivated to do so because Morariu teaches that eicosapentaenoic acid has collagenase inhibitor activities (see, e.g., Morariu, [0086]) and α-linolenic acid has anti-inflammatory agent (see, e.g., Morariu, [0108]). Moreover, Kuang teaches an eye cream formulation that “comprises the following specific components in 100 parts by weight: 40-80% of water, 1-10% of glycerol, 1-10% of angelica sinensis extract, 1-10% of pseudo-ginseng extract and 0.05-3% of astragalus membranaceus extract” and wherein the formulation exhibits anti-allergic and anti-inflammatory properties (see, e.g., Kuang, English Translation, Abstract). Therefore, based on the teachings of Kuang and Morariu, it would have been obvious to include eicosapentaenoic acid and α-linolenic acid in the skin care composition in order for the composition to exhibit collagenase inhibitor activities and anti-inflammatory activities. One would have expected success because Kuang and Morariu both teach skin care formulations with anti-inflammatory properties.
Regarding claim 22’s amount limitations, those working in the biological and/or pharmaceutical arts would understand that adjustments of particular conventional working conditions (e.g., concentration, amount, percentages, etc., of a compound) is deemed a matter of judicious selection and routine optimization, which is within the purview of the skilled artisan. For example, Kuang teaches that the CBD can initiate various immune responses and oputina stem extract can promote blood circulation, diminish inflammation, detoxify, and promote tissue regeneration (see, e.g., Kuang, English Translation, pg. 3). Additionally, Morariu teaches that eicosapentaenoic acid is a collagenase inhibitor and α-linolenic acid is an anti-inflammatory agent (see, e.g., Morariu, [0086], [0108]). Furthermore, Stinchcomb teaches “It is to be understood that any ranges, ratios and ranges of ratios that can be formed by, or derived from, any of the data disclosed herein represents further embodiments of the present disclosure and are included as a part of the disclosure as though they were explicitly set forth. This includes ranges that can be formed that do or do not include a finite upper and/or lower boundary. Accordingly, a person of ordinary skill in the art most closely related to a particular range, ratio or range of ratios will appreciate that such values are unambiguously derivable from the data presented herein” (see, e.g., Stinchcomb, [0182]). Therefore, one of ordinary skill in the art would reasonably understand that the amount of each component within the skin care formulation would influence its effects on, for example, immune responses, inflammation, tissue regeneration, anti-collagenase activity, etc. This is motivation for someone of ordinary skill in the art to practice or test the parameter widely to find those that are functional or optimal which then would be inclusive or cover the steps as instantly claimed. Absent any teaching of criticality by the Applicant concerning the amounts of each component, it would be prima facie obvious that one of ordinary skill in the art would recognize these limitations are result effective variables which can be met as a matter of routine optimization.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Kuang as applied to claims 1-3, 8-9, 14, and 18-20 above, and further in view of Bonina (US 2017/0100447; Date of Publication: April 13, 2017), Rousseau (WO 2021/087314; Date of Publication: May 5, 2021) Stinchcomb (US 2011/0052694; Date of Publication: March 3, 2011 – previously cited above), and Morariu (US 2006/0216251; Date of Publication: September 28, 2006), as evidenced by Aremu (What are humectants, and what do they do?; 2022), Lauren (What is a wetting agent and where are they used?; 2025), and Cleveland Clinic (Emollients; 2022).
Kuang’s general disclosure is discussed above.
Regarding claim 23 pertaining to the skin care formulation, Kuang teaches an eye cream comprising 0.05-3% cannabidiol (see, e.g., Kuang, English Translation, Claim 1), 0.05 to 0.5% sodium hyaluronate (see, e.g., Kuang, English Translation, Claim 1), 0.1 to 1% of benzyl alcohol (see, e.g., Kuang, English Translation, claim 1), 0.1-6% caprylic/capric triglycerides which are medium chain triglycerides (see, e.g., Kuang, English Translation, claim 1); and 40-80% water as the solvent (see, e.g., Kuang, English Translation, Claims 1-2).
However, Kuang does not teach: 2500 mg of opuntia fruit extract (claim 23); or 500 mg of papain (claim 23); or 0.75 mg of sorbitan monostearate (claim 23); or 3 mg of tween 80 (claim 23); or 6 mg of cetostearyl alcohol (claim 23); or 5 mg of propylene glycol (claim 23); or 0.14 mg of methyl paraben (claim 23); or 1 mg of thymol (claim 23); or 5 mg of isopropyl myristate (claim 23).
Bonina’s general disclosure is discussed above.
Regarding claim 23 pertaining to Opuntia fruit extract, Bonina teaches cosmetic compositions comprising “an extract of flowers and/or fruits of Opuntia Ficus Indica” (see, e.g., Bonina, [0024]), wherein for topical administration the concentration range can vary between 0.5-5% (see, e.g., Bonina, [0029]).
Rousseau’s general disclosure is discussed above.
Regarding claim 23 pertaining to the skin care formulation, Rousseau teaches that the composition can also comprise a humectant, wherein the humectant can be propylene glycol in an amount from about 2% to about 25% by weight (see, e.g., Rousseau, [0015]). Moreover, Rousseau teaches that another humectant that can be used within the composition is isopropyl myristate (see, e.g., Rousseau, [0079]), wherein “the humectant is present on the reconstituted plant material in an amount less than about 25% by weight, such as in an amount less than about 20% by weight, and generally in an amount less than about 15% by weight. The humectant may be present on the plant material in an amount greater than about 3% by weight, such as in an amount greater than about 5% by weight” (see, e.g., Rousseau, [0080]).
Stinchcomb’s general disclosure is discussed above.
Regarding claim 23 pertaining to the skin care formulation, Stinchcomb teaches that the pharmaceutical composition can comprise a surfactant for use as a wetting agent, such as sorbitan monostearate, wherein the wetting agent can be in the amount of about 0.25% to 15% (see, e.g., Stinchcomb, [0111]). Stinchcomb teaches penetration enhancers, such as nonionic surfactants including tween 80, can be included in the composition (see, e.g., Stinchcomb, [0092]). Moreover, Stinchcomb teaches that the penetration enhancer can be present in the amount of about 0.1% to 95% (see, e.g., Stinchcomb, [0098]). Stinchcomb teaches that the pharmaceutical composition can comprise emollients, such as cetostearyl alcohol, in the amount by weight of about 1% to about 30% (see, e.g., Stinchcomb, [0114]). Stinchcomb teaches methyl paraben, which is an antimicrobial preservative, can be added to the pharmaceutical composition, wherein the antimicrobial preservative is present in the amount of about 0.1% to about 5% (see, e.g., Stinchcomb, [0116]).
Morariu’s general disclosure is discussed above.
Regarding claim 23 pertaining to the skin care formulation, Morariu teaches a topical composition that can comprise papain, which has anti-edemic activity (see, e.g., Morariu, [0122]). Moreover, Morariu teaches that the composition can comprise thymol, which has anti-acne activity (see, e.g., Morariu, [0118]).
It would have been first obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce Kuang’s eye cream composition, wherein the composition further comprises Opuntia fruit extract, as taught by Bonina. One would have been motivated to do so because Bonina teaches that Opuntia ficus fruit extract inhibits 5-alpha reductase, which is beneficial in prevention or treatment of androgenic alopecia and acne (see, e.g., Bonina, abstract). Moreover, Kuang teaches an eye cream formulation that “comprises the following specific components in 100 parts by weight: 40-80% of water, 1-10% of glycerol, 1-10% of angelica sinensis extract, 1-10% of pseudo-ginseng extract and 0.05-3% of astragalus membranaceus extract” and wherein the formulation exhibits anti-allergic and anti-inflammatory properties (see, e.g., Kuang, English Translation, Abstract). Therefore, based on the teachings of Kuang and Bonina, it would have been obvious to include Opuntia ficus fruit extract within the skin care formulation in order to produce a composition that prevents or treats androgenic alopecia and acne, while also exhibiting anti-allergic and anti-inflammatory properties. One would have expected success because Kuang and Bonina both teach skin care formulations comprising extracts from different parts of Opuntia species.
It would have been secondly obvious to one of ordinary skill in the art to produce Kuang’s eye cream composition, wherein the composition further comprises propylene glycol, and isopropyl myristate, as taught by Rousseau. One would have been motivated to do so because Rousseau teaches a skin care composition comprising cannabis (see, e.g., Rosseau, abstract). Rousseau teaches that propylene glycol and isopropyl myristate are humectants (see, e.g., Rousseau, [0011], [0079]), which is inherently a water-attracting substance that can relieve dry skin, reduce thickened skin, and strengthen the skin barrier (see, e.g., Aremu, Art of Record). Moreover, Kuang teaches an eye cream formulation that “comprises the following specific components in 100 parts by weight: 40-80% of water, 1-10% of glycerol, 1-10% of angelica sinensis extract, 1-10% of pseudo-ginseng extract and 0.05-3% of astragalus membranaceus extract” and wherein the formulation exhibits anti-allergic and anti-inflammatory properties (see, e.g., Kuang, English Translation, Abstract). Therefore, based on the teachings of Kuang and Rousseau, it would have been obvious to produce a skin care formulation hat comprises propylene glycol and isopropyl myristate because the propylene glycol and isopropyl myristate would increase the moisturizing capability of the formulation. One would have expected success because Kuang and Rousseau both teach skin care formulations comprising cannabidiol.
It would have been thirdly obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce Kuang’s eye cream composition, wherein the composition further comprises sorbitan monostearate, tween 80, cetostearyl alcohol, and methyl paraben, as taught by Stinchcomb. One would have been motivated to do so because Stinchcomb teaches a pharmaceutical composition comprising cannabidiol for the treatment of diseases and disorders (see, e.g., Stinchcomb, abstract). Furthermore, Stinchcomb teaches that sorbitan monostearate is a surfactant for use as a wetting agent (see, e.g., Stinchcomb, [0111]), wherein wetting agents, otherwise known as surfactants, inherently lower the surface tension of water allowing liquid to spread across solid surfaces evenly (see, e.g., Lauren, Art of Record). Additionally, Stinchcomb teaches tween 80 is a nonionic penetration enhancer, wherein “Nonionic surfactants enhance penetration in part by emulsifying the sebum and enhancing the thermodynamic activity or solubility of the active” (see, e.g., Stinchcomb, [0092]). Stinchcomb teaches that cetostearyl alcohol is and emollient (see, e.g., Stinchcomb, [0114]), wherein an emollient inherently softens and sooths skin, and contains ingredients such as creams, lotions, or ointments (see, e.g., Cleveland Clinic, Art of Record). Lastly, Stinchcomb teaches methyl paraben, which is an antimicrobial preservative, can be added to the pharmaceutical composition, (see, e.g., Stinchcomb, [0116]). Moreover, Kuang teaches “an industrial hemp leaf eye cream for removing dark circles, resisting allergy and diminishing inflammation” (see, e.g., Kuang, English Translation, Abstract). Therefore, based on the teachings of Kuang and Stinchcomb, it would have been obvious to produce a skin care formulation that comprises sorbitan monostearate, tween 80, cetostearyl alcohol, and methyl paraben. One would have expected success because Kuang and Stinchcomb both teach topical pharmaceutical compositions comprising cannabidiol.
It would have been fourthly obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce Kuang’s eye cream composition, wherein the composition further comprises papain, and thymol, as taught by Morariu. One would have been motivated to do so because Morariu teaches that papain has anti-edemic activity (see, e.g., Morariu, [0122]) and thymol has anti-acne activity (see, e.g., Morariu, [0118]). Moreover, Kuang teaches “an industrial hemp leaf eye cream for removing dark circles, resisting allergy and diminishing inflammation” (see, e.g., Kuang, English Translation, Abstract). Therefore, based on the teachings of Kuang and Morariu, it would have been obvious to include papain and thymol within the skin care formulation in order to produce a formulation that as anti-edemic and anti-acne activity, as well as ant-allergenic and anti-inflammatory. One would have expected success because Kuang and Morariu both teach skin care formulations with anti-inflammatory properties.
Regarding claim 22’s amount limitations, those working in the biological and/or pharmaceutical arts would understand that adjustments of particular conventional working conditions (e.g., concentration, amount, percentages, etc., of a compound) is deemed a matter of judicious selection and routine optimization, which is within the purview of the skilled artisan. For example, Kuang teaches that the CBD can initiate various immune responses and oputina stem extract can promote blood circulation, diminish inflammation, detoxify, and promote tissue regeneration (see, e.g., Kuang, English Translation, pg. 3). Additionally, Morariu teaches that eicosapentaenoic acid is a collagenase inhibitor and α-linolenic acid is an anti-inflammatory agent (see, e.g., Morariu, [0086], [0108]). Furthermore, Stinchcomb teaches “It is to be understood that any ranges, ratios and ranges of ratios that can be formed by, or derived from, any of the data disclosed herein represents further embodiments of the present disclosure and are included as a part of the disclosure as though they were explicitly set forth. This includes ranges that can be formed that do or do not include a finite upper and/or lower boundary. Accordingly, a person of ordinary skill in the art most closely related to a particular range, ratio or range of ratios will appreciate that such values are unambiguously derivable from the data presented herein” (see, e.g., Stinchcomb, [0182]). Therefore, one of ordinary skill in the art would reasonably understand that the amount of each component within the skin care formulation would influence its effects on, for example, immune responses, inflammation, tissue regeneration, anti-collagenase activity, etc. This is motivation for someone of ordinary skill in the art to practice or test the parameter widely to find those that are functional or optimal which then would be inclusive or cover the steps as instantly claimed. Absent any teaching of criticality by the Applicant concerning the amounts of each component, it would be prima facie obvious that one of ordinary skill in the art would recognize these limitations are result effective variables which can be met as a matter of routine optimization.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Kuang as applied to claims 1-3, 8-9, 14, and 18-20 above, and further in view of Bonina (US 2017/0100447; Date of Publication: April 13, 2017), Rousseau (WO2021/087314; Date of Publication: May 5, 2021), Stinchcomb (US 2011/0052694; Date of Publication: March 3, 2011), Rawlings (U.S. Patent No. 5,439,935; Date of Publication: August 8, 1995 – cited above), Morariu (US 2006/0216251; Date of Publication: September 28, 2006), Finley (US 2016/0346339; Date of Publication: December 1, 2016), and Hossain (US 2019/0142788; Date of Publication: May 16, 2019), as evidenced by Aremu (What are humectants, and what do they do?; 2022) and Lauren (What is a wetting agent and where are they used?; 2025).
Kuang’s general disclosure is discussed above.
Regarding claim 24 pertaining to the skin care formulation, Kuang teaches an eye cream comprising 0.05-3% cannabidiol (see, e.g., Kuang, English Translation, Claim 1), 0.05 to 0.5% sodium hyaluronate (see, e.g., Kuang, English Translation, Claim 1), and 40-80% water as the solvent (see, e.g., Kuang, English Translation, Claims 1-2).
However, Kuang does not teach: 5000 mg of opuntia fruit extract (claim 24); or 250 mg of papaya extract (claim 24); or 5 mg of tween 60 (claim 24); or 5 mg of cetomacrogol emulsifying wax (claim 24); or 0.1 mg of citronellol (claim 24); or 5 mg of propylene glycol (claim 24); or 1 mg of myrrh resin (claim 24); or 0.15 mg of thymol (claim 24); or 0.15 mg of cinnamaldehyde (claim 24); or 0.5 mg of ascorbyl palmitate (claim 24); or 4 mg of fish oil (claim 24); or 2 mg of eicosapentaenoic acid (claim 24); or 2 mg of α-Linolenic acid (claim 24); or 5 mg of isopropyl myristate (claim 24).
Bonina’s general disclosure is discussed above.
Regarding claim 24 pertaining to Opuntia fruit extract, Bonina teaches cosmetic compositions comprising “an extract of flowers and/or fruits of Opuntia Ficus Indica” (see, e.g., Bonina, [0024]), wherein for topical administration the concentration range can vary between 0.5-5% (see, e.g., Bonina, [0029]).
Rousseau’s general disclosure is discussed above.
Regarding claim 24 pertaining to the skin care formulation, Rousseau teaches that the composition can also comprise a humectant, wherein the humectant can be propylene glycol in an amount from about 2% to about 25% by weight (see, e.g., Rousseau, [0015]). Moreover, Rousseau teaches that another humectant that can be used within the composition is isopropyl myristate (see, e.g., Rousseau, [0079]), wherein “the humectant is present on the reconstituted plant material in an amount less than about 25% by weight, such as in an amount less than about 20% by weight, and generally in an amount less than about 15% by weight. The humectant may be present on the plant material in an amount greater than about 3% by weight, such as in an amount greater than about 5% by weight” (see, e.g., Rousseau, [0080]).
Stinchcomb’s general disclosure is discussed above.
Regarding claim 24 pertaining to the skin care formulation, Stinchcomb teaches penetration enhancers, such as nonionic surfactants including tween 60, can be included in the composition (see, e.g., Stinchcomb, [0092]).
Morariu’s general disclosure is discussed above.
Regarding claim 24 pertaining to the skin care formulation, Morariu teaches that the composition can comprise thymol, which has anti-acne activity (see, e.g., Morariu, [0118]). Additionally, Morariu teaches that ascorbyl palmitate, which is a fatty acid ester of ascorbic acid, has antioxidative action and can be added to the composition (see, e.g., Morariu, [0052]). Morariu teaches that the skin care composition can comprise eicosapentaenoic acid, which has collagenase inhibitor activities (see, e.g., Morariu, [0086]). Morariu teaches that the skin care composition can comprise α-linolenic acid and cinnamaldehyde, which are anti-inflammatory agents (see, e.g., Morariu, [0108]).
Finley’s general disclosure is related to “cannabis oil extracts and compositions thereof, including cannabis oil compositions containing vitamin E, and methods for preparing the extracts and compositions. In some embodiments, the present invention provides a method for preparing a cannabis oil extract comprising eluting cannabinoids from cannabis plant material with a solvent to produce an eluate, filtering the eluate with a filter to produce a filtrate, evaporating the solvent from the filtrate with a distiller to produce a distillate, and purging the distillate under conditions sufficient to remove residual solvent, thereby preparing the extract” (see, e.g., Finley, abstract).
Regarding claim 24 pertaining to the skincare composition, Finley teaches that the composition can comprise a Carica papaya herbal extract (see, e.g., Finley, [0161]). Additionally, the composition can comprise terpenes, which are present in the cannabis oil, such as citronellol (see, e.g., Finley, [0134]). Finley teaches “terpenes are present in the oils of the invention in total amounts ranging from about 0.1% (w/w) to about 15% (w/w)” (see, e.g., Finley, [0136]). Moreover, Finely teaches that the composition can comprise an additional carrier oil added to the cannabis oil, such as fish oil, wherein the carrier oil is present in the amount ranging from about 1% (w/w) to about 95% (w/w) (see, e.g., Finley, [0165]-[0166]). Additionally, Finley teaches myrrh as an essential oil or herbal extract within the composition (see, e.g., Finley, [0160]-[0161])
Hossain’s general disclosure relates to “methods and compositions for the treatment of diseases and conditions that are associated with intermediate filament dysfunction, particularly employing topical application of cannabinoids” (see, e.g., Hossain, [0002]). Moreover, Hossain discloses “various cannabinoids (including mixtures of cannabidiols and cannabinol) upregulate expression of various keratins such that loss of function in other keratin genes may be compensated for. By way of this upregulation, these cannabinoids can be used to treat epidermolysis bullosa and other connective tissue disorders arising from intermediate filament dysfunction” (see, e.g., Hossain, abstract).
Regarding claim 24 pertaining to the cetomacrogol emulsifying resin, Hossain teaches that within the composition, the wetting, solubilizing, or emulsifying agent is typically a surfactant, wherein the surfactant can be cetomacrogol (see, e.g., Hossain, [0188]).
It would have been first obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce Kuang’s eye cream composition, wherein the composition further comprises Opuntia fruit extract, as taught by Bonina. One would have been motivated to do so because Bonina teaches that Opuntia ficus fruit extract inhibits 5-alpha reductase, which is beneficial in prevention or treatment of androgenic alopecia and acne (see, e.g., Bonina, abstract). Moreover, Kuang teaches an eye cream formulation that “comprises the following specific components in 100 parts by weight: 40-80% of water, 1-10% of glycerol, 1-10% of angelica sinensis extract, 1-10% of pseudo-ginseng extract and 0.05-3% of astragalus membranaceus extract” and wherein the formulation exhibits anti-allergic and anti-inflammatory properties (see, e.g., Kuang, English Translation, Abstract). Therefore, based on the teachings of Kuang and Bonina, it would have been obvious to include Opuntia ficus fruit extract within the skin care formulation in order to produce a composition that prevents or treats androgenic alopecia and acne, while also exhibiting anti-allergic and anti-inflammatory properties. One would have expected success because Kuang and Bonina both teach skin care formulations comprising extracts from different parts of Opuntia species.
It would have been secondly obvious to one of ordinary skill in the art to produce Kuang’s eye cream composition, wherein the composition further comprises propylene glycol, and isopropyl myristate, as taught by Rousseau. One would have been motivated to do so because Rousseau teaches a skin care composition comprising cannabis (see, e.g., Rosseau, abstract). Rousseau teaches that propylene glycol and isopropyl myristate are humectants (see, e.g., Rousseau, [0011], [0079]), which is inherently a water-attracting substance that can relieve dry skin, reduce thickened skin, and strengthen the skin barrier (see, e.g., Aremu, Art of Record). Moreover, Kuang teaches an eye cream formulation that “comprises the following specific components in 100 parts by weight: 40-80% of water, 1-10% of glycerol, 1-10% of angelica sinensis extract, 1-10% of pseudo-ginseng extract and 0.05-3% of astragalus membranaceus extract” and wherein the formulation exhibits anti-allergic and anti-inflammatory properties (see, e.g., Kuang, English Translation, Abstract). Therefore, based on the teachings of Kuang and Rousseau, it would have been obvious to produce a skin care formulation hat comprises propylene glycol and isopropyl myristate because the propylene glycol and isopropyl myristate would increase the moisturizing capability of the formulation. One would have expected success because Kuang and Rousseau both teach skin care formulations comprising cannabidiol.
It would have been thirdly obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce Kuang’s eye cream composition, wherein the composition further comprises tween 60, as taught by Stinchcomb. One would have been motivated to do so because Stinchcomb teaches tween 60 is a nonionic penetration enhancer, wherein “Nonionic surfactants enhance penetration in part by emulsifying the sebum and enhancing the thermodynamic activity or solubility of the active” (see, e.g., Stinchcomb, [0092]). Moreover, Kuang teaches “an industrial hemp leaf eye cream for removing dark circles, resisting allergy and diminishing inflammation” (see, e.g., Kuang, English Translation, Abstract). Therefore, based on the teachings of Kuang and Stinchcomb, it would have been obvious to produce a skin care formulation that comprises tween 60 because this would result in enhanced penetration of the active ingredient(s) within the topical formulation. One would have expected success because Kuang and Stinchcomb both teach topical pharmaceutical compositions comprising cannabidiol.
It would have been fourthly obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce Kuang’s eye cream composition, wherein the composition further comprises thymol, ascorbyl palmitate, and cinnamaldehyde, as taught by Morariu. One would have been motivated to do so because Morariu teaches that thymol has anti-acne activity, ascorbyl palmitate has antioxidative properties, and cinnamaldehyde has anti-inflammatory properties (see, e.g., Morariu, [0108]). Moreover, Kuang teaches “an industrial hemp leaf eye cream for removing dark circles, resisting allergy and diminishing inflammation” (see, e.g., Kuang, English Translation, Abstract). Therefore, based on the teachings of Kuang and Morariu, it would have been obvious to include thymol, ascrobyl palmitate, and cinnamaldehyde within the skin care formulation in order to produce a formulation that has anti-acne, anti-oxidative, and anti-inflammatory properties. One would have expected success because Kuang and Morariu both teach skin care formulations with anti-inflammatory properties.
It would have been fifthly obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce Kuang’s eye cream composition, wherein the composition further comprises eicosapentaenoic acid and α-linolenic acid, as taught by Morariu. One would have been motivated to do so because Morariu teaches that eicosapentaenoic acid has collagenase inhibitor activities (see, e.g., Morariu, [0086]) and α-linolenic acid has anti-inflammatory agent (see, e.g., Morariu, [0108]). Moreover, Kuang teaches an eye cream formulation that “comprises the following specific components in 100 parts by weight: 40-80% of water, 1-10% of glycerol, 1-10% of angelica sinensis extract, 1-10% of pseudo-ginseng extract and 0.05-3% of astragalus membranaceus extract” and wherein the formulation exhibits anti-allergic and anti-inflammatory properties (see, e.g., Kuang, English Translation, Abstract). Therefore, based on the teachings of Kuang and Morariu, it would have been obvious to include eicosapentaenoic acid and α-linolenic acid in the skin care composition in order for the composition to exhibit collagenase inhibitor activities and anti-inflammatory activities. One would have expected success because Kuang and Morariu both teach skin care formulations with anti-inflammatory properties.
It would have been sixthly obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce Kuang’s eye cream composition, wherein the composition further comprises papaya extract, citronellol, myrrh, and fish oil, and taught by Finley. One would have been motivated to do so because Finley teaches that papaya extract and myrrh can be added as an essential oil (see, e.g., Finley, [0160]), wherein “one or more essential oils are added to the extracted cannabis oil to provide properties such as improved palatability. Essential oils can also provide antioxidant and preservative properties in the cannabis oil compositions” (see, e.g., Finley, [0154]). Additionally, Finley teaches that fish oil can be a carrier oil that is added to the cannabis oil (see, e.g., Finley, [0165]) and oral administration of the preparation can take the form of a liquid preparation prepared using fish oil (see, e.g., Finley, [0175]). Moreover, Kuang teaches an eye cream formulation that “comprises the following specific components in 100 parts by weight: 40-80% of water, 1-10% of glycerol, 1-10% of angelica sinensis extract, 1-10% of pseudo-ginseng extract and 0.05-3% of astragalus membranaceus extract” and wherein the formulation exhibits anti-allergic and anti-inflammatory properties (see, e.g., Kuang, English Translation, Abstract). Therefore, based on the teachings of Kuang and Finley, it would have been obvious to one of ordinary skill in the art to prepare a skin care composition further comprising papaya extract, citronellol, myrrh, and fish oil due to the anti-oxidant and preservative properties exhibited by these ingredients. One would have expected success because Kuang and Finley both teach skin care formulations comprising cannabidiol.
It would have been seventhly obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce Kuang’s eye cream composition, wherein the composition further comprises cetomacrogol, as taught by Hossain. One would have been motivated to do so because Hossain teaches that within the composition, the wetting, solubilizing, or emulsifying agent is typically a surfactant, wherein the surfactant can be cetomacrogol (see, e.g., Hossain, [0188]). Furthermore, a surfactant inherently lowers the surface tension of water allowing liquid to spread across solid surfaces evenly (see, e.g., Lauren, Art of Record). Moreover, Kuang teaches “an industrial hemp leaf eye cream for removing dark circles, resisting allergy and diminishing inflammation” (see, e.g., Kuang, English Translation, Abstract). Therefore, based on the teachings of Kuang and Hossain, it would have been obvious to include cetomacrogol in the skin care formulation in order to produce a composition that has decreased surface tension thereby allowing the formulation to spread across solid surfaces evenly. One would have expected success because Kuang and Hossain both teach skin care formulations comprising cannabidiol.
Regarding claim 22’s amount limitations, those working in the biological and/or pharmaceutical arts would understand that adjustments of particular conventional working conditions (e.g., concentration, amount, percentages, etc., of a compound) is deemed a matter of judicious selection and routine optimization, which is within the purview of the skilled artisan. For example, Kuang teaches that the CBD can initiate various immune responses and oputina stem extract can promote blood circulation, diminish inflammation, detoxify, and promote tissue regeneration (see, e.g., Kuang, English Translation, pg. 3). Additionally, Morariu teaches that eicosapentaenoic acid is a collagenase inhibitor and α-linolenic acid is an anti-inflammatory agent (see, e.g., Morariu, [0086], [0108]). Furthermore, Stinchcomb teaches “It is to be understood that any ranges, ratios and ranges of ratios that can be formed by, or derived from, any of the data disclosed herein represents further embodiments of the present disclosure and are included as a part of the disclosure as though they were explicitly set forth. This includes ranges that can be formed that do or do not include a finite upper and/or lower boundary. Accordingly, a person of ordinary skill in the art most closely related to a particular range, ratio or range of ratios will appreciate that such values are unambiguously derivable from the data presented herein” (see, e.g., Stinchcomb, [0182]). Therefore, one of ordinary skill in the art would reasonably understand that the amount of each component within the skin care formulation would influence its effects on, for example, immune responses, inflammation, tissue regeneration, anti-collagenase activity, etc. This is motivation for someone of ordinary skill in the art to practice or test the parameter widely to find those that are functional or optimal which then would be inclusive or cover the steps as instantly claimed. Absent any teaching of criticality by the Applicant concerning the amounts of each component, it would be prima facie obvious that one of ordinary skill in the art would recognize these limitations are result effective variables which can be met as a matter of routine optimization.
Conclusion
Claims 1-24 are rejected.
No claims are allowed.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE IANNUZO whose telephone number is (703)756-5559. The examiner can normally be reached Mon - Fri: 8:30-6:00 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached at (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NATALIE IANNUZO/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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