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 of Group I, claims 58-73 and 79 in the reply filed on April 21, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 74-78, (Groups II and III, drawn to the process of preparation and the method of treatment), are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicant additionally elects the species of penetrator compound: (i) propylene glycol and (ii) propylene glycol and pentylene glycol; elects the ingredient: wound healing compound (but does not elect a single specific compound); and the further cannabinoid: CBG.
Claims 58-73 and 79 are under examination and are the subject of this office action.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 21, 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner, please refer to the signed copy of Applicant’s PTO-1449 form, attached herewith.
Claim Objections
8. Claims 59-72 are objected to for missing the article “The” before the term “composition” at the beginning of each claim.
9. Claim 59 is objected to because the phrase “wherein the CBD used in the provision of the CBD-comprising composition has a purity…” is clunky and superfluous. The claim should read “wherein the CBD has a purity…”.
10. Claim 73 is objected to for using the article “A” before “composition” in line 1. The article “The” should be used instead.
Claim 73 is also missing the term “or” before the term “around 61%” at the end of line 3, and the claim is missing the term “or” before the term “around 61%” at the end of line 25.
11. Claim 79 is objected to for using the article “a” before “wound treatment composition” in lines 1-2. The article “the” should be used instead. Claim 79 is also missing a period at the end of the claim.
Claim Rejections - 35 USC § 112(b)
12. 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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
13. Claims 58-73 and 79 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, 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.
14. Claim 58 is rejected as being indefinite because a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 58 recites the broad recitation of the range “a) 0.1-5% … cannabidiol (CBD)”, and the claim also recites the ranges “0.2-2%,” or “0.3-1%,” or “0.4-0.75%” and the explicit amount of “or around 0.5% (w/w)” which are the narrower statements of the range/limitation.
The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
15. Claim 59 is rejected as being indefinite in the following aspects
(a) Claim 59 depends from claim 58 and recites the limitation of: “the provision of the CBD-comprising composition” in lines 1.2. However there is insufficient antecedent basis for the limitation of “the provision” and “the CBD-comprising composition” because there is no prior recitation of the limitations of “the provision” or “the CBD-comprising composition” in claim 58.
(b) Claim 59 depends from claim 58 and recites the limitation of: “the crystals.” There is insufficient antecedent basis for the limitation of “the crystals” because there is no prior recitation of the limitation of “the crystals” in claim 58.
16. Claim 62 is indefinite in the following aspects:
(a) Claim 62 is rejected as being indefinite regarding the recitation “wherein the composition is formulated as a gel,” in lines 1-2 because it is not clear if the claim intends for the formulation of claim 60 to be in the form of gel or if this is an additional, as-yet unrecited step of preparing a gel composition.
(b) Claim 62 is rejected as being indefinite because a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 62 recites the broad recitation of the range of the amount of gelators of “0.1-5%”, and the claim also recites the ranges “0.2-3%,” or “0.5-2%,” or “0.6-1.0%” and the explicit amount “around 0.8% (w/w)” which are the narrower statements of the range/limitation.
The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
17. Claim 68 is rejected as being indefinite because a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 68 recites the broad recitation of the range of the concentration of wound healing compounds of “0.1-5%”, and the claim also recites the ranges “0.2-2%,” or “0.3-1%,” or “0.4-0.75%” and the explicit amount “around 0.5% (w/w)” which are the narrower statements of the range/limitation.
The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
18. Claim 69 is rejected as being indefinite because a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 69 recites the broad recitation of the range of the concentration of propylene glycol penetrators of “0.1-60%”, and the claim also recites the ranges “5-55%,” or “10-50%,” or “30-50%,” or “35-35%” and the explicit amount “around 30% (w/w)” which are the narrower statements of the range/limitation.
The claim additionally recites the broad recitation of the range of the concentration of pentylene glycol penetrators of “0.1-15%”, and the claim also recites the ranges “0.5-12%,” or “1.0-10%,” or “1.5-7.5%,” or “2.0-6.0%” or “2.5-4.0%” and the explicit amount “around 5% (w/w)” which are the narrower statements of the range/limitation.
The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
19. Claim 70 is rejected as being indefinite because a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 70 recites the broad recitation of the range of the concentration of antimicrobial agents of “0.01-2.5%”, and the claim also recites the ranges “0.025-1.0%,” or “0.05-.5%,” or “0.075-0.2%,” and the explicit amount “around 0.1% (w/w)” which are the narrower statements of the range/limitation.
The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
20. Claim 71 is rejected as being indefinite because a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 71 recites the broad recitation of the range of the concentration of panthenol of “0.1-5%”, and the claim also recites the ranges “0.15-3.0%,” or “0.2-1.5%,” or “0.5-0.8%,” and the explicit amount “around 0.65% (w/w)” which are the narrower statements of the range/limitation.
The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
21. Claim 72 is rejected as being indefinite because a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 72 recites the broad recitation of the range of the concentration of allantoin of “0.01-5%”, and the claim also recites the ranges “0.05-2.0%,” or “0.1-1%,” or “0.2-0.5%,” and the explicit amount “around 0.3% (w/w)” which are the narrower statements of the range/limitation.
The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
22. Claim 73 is rejected as being indefinite in the following aspects:
(a) Claim 73 is rejected because a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the claim 73, each of the components “a”-“j” in formula (I) and each of the components “a”-“j” in formula (II) recites the broad recitation of the range of the concentration of the component, followed by a narrower statement of the range/limitation, followed by the explicit amount “or around __%” of the component, which are even narrower statements of the range/limitation.
The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language for each component “a”-“j” of formula (I) and each component “a”-“j” of formula (II) is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claim.
(b) Claim 73 depends from claim 60 and recites the limitation of: “a. 20-85% (w/w), 40-75% (w/w), 50-70% (w/w), 55-65% (w/w), around 61% (w/w) water” in formula (I). There is insufficient antecedent basis for the limitation because claim 60 is dependent upon claim 58, which recites the amount of water: “b) 25-85 %, 35-75 %, 45-70 % or 55-65 % (w/w) water”. Therefore there is no prior recitation of “a. 20-85% (w/w), 40-75% (w/w), 50-70% (w/w), 55-65% (w/w), around 61% water” in claim 58.
(c) Claim 73 also recites the limitation of: “a. 55-65% (w/w), around 61% (w/w) water” in formula (II). There is insufficient antecedent basis for the limitation because claim 60 is dependent upon claim 58, which recites the amount of water: “b) 25-85 %, 35-75 %, 45-70 % or 55-65 % (w/w) water”. Therefore there is no prior recitation of “around 61% water” in claim 58.
(d) Claim 73 also recites the limitation of: “e. 0.1-5% (w/w), 0.15-2% (w/w), 0.2-1% (w/w), 0.25-0.75% (w/w), or around 0.5% (w/w) CBD” in formula (I). There is insufficient antecedent basis for the limitation because claim 60 is dependent upon claim 58, which recites the amount of CBD: “a) 0.1-5%, 0.2-2%, 0.3-1%, 0.4-0.75%, or around 0.5% (w/w) cannabidiol (CBD)”. Therefore there is no prior recitation of the limitation of “e. 0.1-5% (w/w), 0.15-2% (w/w), 0.2-1% (w/w), 0.25-0.75% (w/w), or around 0.5% (w/w) CBD” in claim 58.
(e) Claim 73 also recites the limitation of: “e. 0.25-0.75% (w/w), or around 0.5% (w/w) CBD” in formula (II). There is insufficient antecedent basis for the limitation because claim 60 is dependent upon claim 58, which recites the amount of CBD: “a) 0.1-5%, 0.2-2%, 0.3-1%, 0.4-0.75%, or around 0.5% (w/w) cannabidiol (CBD)”. Therefore there is no prior recitation of the limitation of “e. 0.25-0.75% (w/w), or around 0.5% (w/w) CBD” in claim 58.
Claim Rejections - 35 USC § 101
23. 35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
24. Claims 58-73 and 79 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more.
25. Claim 58 recites a composition formulated as a wound treatment composition for topical application comprising by weight:
(a) 0.1-5%, 0.2-2%, 0.3-1%, 0.4-0.75%, or around 0.5% (w/w) cannabidiol (CBD)
(b) 25-85%, 35-75%, 45-70% or 55-65% (w/w) water; and
(c) one or more penetrator(s),
which is a product of nature.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant’s claim 58 is directed to a product; thus, the answer to Step 1 is Yes.
The analysis then moves to Step 2A, Prong One, which asks if a claim recites a product of nature. In this case, Applicant’s claim recites a composition formulated as a wound treatment composition for topical application comprising by weight:
(a) 0.1-5%, 0.2-2%, 0.3-1%, 0.4-0.75%, or around 0.5% (w/w) cannabidiol (CBD)
(b) 25-85%, 35-75%, 45-70% or 55-65% (w/w) water; and
(c) one or more penetrator(s).
Cannabidiol, water, and one or more terpenes are all naturally occurring. Cannabis terpenes are naturally occurring permeation enhancers, e.g., 1,8-cinieole (eucalyptol), d-limonene, and/or l-menthol, that can be found in cannabis plants (see Chen et al., Molecules (2016), Vol 16, page 2, under “2. Skin Penetration Enhancement Effect,” as well as the webpage printout of The Semi-Complete List Of Cannabis Terpenes | The Healing Clinics Medical Marijuana Doctors, (2024)). Thus, the claim does recite a product of nature. MPEP § 2106.04(b) states that “When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A.”
MPEP § 2106.04(c)(I) states that “if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception…”. To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states “The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties…”.
In this case, cannabidiol, water, and one or more terpene penetrator(s) naturally occur in a cannabis plant. Thus, the closest naturally occurring counterpart for the claimed composition is cannabis itself. Thus, the claimed composition reads directly on the cannabis plant itself. Thus, there is not considered to be a marked distinction between the claimed product and naturally occurring cannabidiol, water, and one or more terpene penetrators. Thus, the claimed composition as a whole does not display markedly different characteristics in comparison with the naturally occurring counterparts. Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. In this case, applicant’s claims are directed to a composition with an intended use of topical application for wound treatment. MPEP § 2106.04(d)(2) specifically states that a claim is only directed to “an intended use of a claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the ‘treatment or prophylaxis’ consideration.” Therefore, applicant’s intended use is not sufficient to integrate the judicial exception into a practical application. Thus, the answer to Step 2A, Prong Two, is No.
Thus, the analysis must move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by “Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself.” In this case, claim does not recite additional elements.
In addition, applicant’s intended use of topical application for wound treatment is not considered to amount to significantly more. As discussed in MPEP § 2106.05(I)(A), “Generally linking the use of the judicial exception to a particular technological environment or field of use” is not considered to be enough to qualify as significantly more. An intended use of a claimed composition only generally links the exception to the field of use. Therefore, the additional elements are not considered to amount to significantly more. Thus, the answer to Step 2B is No. Consequently, claim 58 is not directed to patent eligible subject matter.
26. Claim 59 is drawn to claim 58, wherein the CBD used in the provision of the CBD-comprising composition has a purity of at least 95% (w/w), 98% (w/w), 99% (w/w), 99.5 (w/w), or more than 99.8% (w/w) and is crystalline; and wherein the CBD crystals are selected from one or more of:
needle-like crystals; crystals not provided by an extraction method comprising critical CO2 extraction; and crystals provided by a method comprising extraction with a C3-C4 alcohol, and one or more crystallisations steps with a C6-C8 alcohol; or
any combination thereof.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant’s claim 59 is directed to a product; thus, the answer to Step 1 is Yes.
The analysis then moves to Step 2A, Prong One, which asks if a claim recites to a product of nature. In this case, Applicant’s claim recites the cannabidiol composition of claim 58, wherein the CBD used in the provision of the CBD-comprising composition has a purity of at least 95% (w/w), 98% (w/w), 99% (w/w), 99.5 (w/w), or more than 99.8% (w/w) and is crystalline; and wherein the CBD crystals are selected from one or more of:
needle-like crystals; crystals not provided by an extraction method comprising critical CO2 extraction; and crystals provided by a method comprising extraction with a C3-C4 alcohol, and one or more crystallisations steps with a C6-C8 alcohol; or any combination thereof.
Cannabidiol, water, and one or more terpenes are all naturally occurring and can be found in cannabis plants. The purity and crystallinity of the cannabidiol are appropriate “chemical structure and form” characteristics resulting from isolating the naturally occurring product, cannabidiol. Thus, the claim does recite a product of nature. MPEP § 2106.04(b) states that “When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A.”
MPEP § 2106.04(c)(I) states that “if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception…”. To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states “The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties…”.
In this case, cannabidiol, water, and one or more terpene penetrator(s) naturally occur in a cannabis plant. The step of isolating the naturally occurring compound cannabidiol from the natural product of cannabis is not a markedly different characteristic because isolated but otherwise unchanged natural products are not eligible, because they are not different enough from what exists in nature. Thus, there is not considered to be a marked distinction between the claimed product, further defined by purity and crystallinity, and naturally occurring cannabidiol. See MPEP § 2106.04(c)(II)(C)(2). Thus, the claimed composition as a whole does not display markedly different characteristics in comparison with the naturally occurring counterparts. Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. In this case, applicant’s claims are directed to a composition with an intended use of topical application for wound treatment. MPEP § 2106.04(d)(2) specifically states that a claim is only directed to “an intended use of a claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the ‘treatment or prophylaxis’ consideration.” Therefore, applicant’s intended use is not sufficient to integrate the judicial exception into a practical application. Thus, the answer to Step 2A, Prong Two, is No.
Thus, the analysis must move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by “Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself.” In this case, the claim recites the limitation that the CBD crystals are not provided by an extraction method comprising critical CO2 extraction, which does not amount to an additional element.
In addition, applicant’s intended use of topical application for wound treatment is not considered to amount to significantly more. As discussed in MPEP § 2106.05(I)(A), “Generally linking the use of the judicial exception to a particular technological environment or field of use” is not considered to be enough to qualify as significantly more. An intended use of a claimed composition only generally links the exception to the field of use. Therefore, the additional elements are not considered to amount to significantly more. Thus, the answer to Step 2B is No. Consequently, claim 59 is not directed to patent eligible subject matter.
27. Claim 60 is drawn to claim 58, further comprising one or more components selected from:
i. One or more gelator(s); ii. One or more skin moisturizer(s), skin conditioner(s), or skin moisturizer(s) and skin conditioner(s); iii. One or more further wound healing compound(s); iv. One or more anti-microbial agent(s); v. One or more pH stabilizer(s); and vi. One or more chelating agent(s); or vii. any combination(s) of (i)-(vi), which is a product of nature.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant’s claim 60 is directed to a product; thus, the answer to Step 1 is Yes.
The analysis then moves to Step 2A, Prong One, which asks if a claim recites a product of nature. In this case, Applicant’s claim recites the composition of claim 58, comprising cannabidiol, water, and one or more terpenes, which are all naturally occurring, as well at least one skin moisturizer, at least one wound healing compound, and at least one antimicrobial agent. Filipiuc et al. teach the therapeutic effects of other terpenoids and cannabinoids derived from cannabis: e.g., CBG and CBGV, naturally occurring cannabinoids found in cannabis treat dry skin: “both CBG and cannabigerovarin (CBGV) exert potential in the treatment of skin dryness” and teach that cannabinoids including CBD and CBG are naturally occurring antimicrobial agents that exist in cannabis: “CBD and CBG may be promising topical antimicrobial agents for different skin conditions,” and teach that CBD and Cannabis sativa extract are beneficial for wound repair (Filipiuc et al., Pharmaceuticals 2023, p. 3, second paragraph, p.3, last paragraph and p.14, third paragraph). Filipiuc et al. go on to teach that “Topical formulations containing natural cannabinoids have shown local analgesic, antipruritic, anti-inflammatory, cicatrizing, or antibacterial actions,” (page 26, second paragraph). Thus, the claim does recite a product of nature. MPEP § 2106.04(b) states that “When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A.”
MPEP § 2106.04(c)(I) states that “if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception…”. To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states “The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties…”.
In this case, cannabidiol, water, one or more terpene penetrator(s), and additional cannabinoids including CBG, CBGV, and other cannabis extracts naturally occur in a cannabis plant. Thus, the closest naturally occurring counterpart for the claimed composition is cannabis itself. Thus, the claimed composition reads directly on the cannabis plant itself. Thus, there is not considered to be a marked distinction between the claimed product and naturally occurring cannabidiol, water, and one or more terpene penetrators. Thus, the claimed composition as a whole does not display markedly different characteristics in comparison with the naturally occurring counterparts. Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. In this case, applicant’s claims are directed to a composition with an intended use of topical application for wound treatment. MPEP § 2106.04(d)(2) specifically states that a claim is only directed to “an intended use of a claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the ‘treatment or prophylaxis’ consideration.” Therefore, applicant’s intended use is not sufficient to integrate the judicial exception into a practical application. Thus, the answer to Step 2A, Prong Two, is No.
Thus, the analysis must move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by “Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself.” In this case, claim recites additional elements comprising at least one skin moisturizer, at least one wound healing compound, and at least one antimicrobial agent, which are also naturally occurring products occurring in cannabis.
However, MPEP § 2106.05(d) states that well-understood, routine, and conventional activities are not sufficient to show that the claims amount to significantly more than the judicial exception. The addition of the naturally occurring components/ cannabinoids already present in cannabis itself does not amount to significantly more than a combination of judicial exception because said cannabinoid components are well-understood, routine and conventional in the field (as taught by Filipiuc et al., above). Thus, combining the CBD composition of claim 58 with an additional natural product such as CBG or CBGV, also found in cannabis, does not amount to significantly more than a combination of judicial exception because mixing compounds is well-understood, routine, and conventional in the field.
In addition, applicant’s intended use of topical application for wound treatment is not considered to amount to significantly more. As discussed in MPEP § 2106.05(I)(A), “Generally linking the use of the judicial exception to a particular technological environment or field of use” is not considered to be enough to qualify as significantly more. An intended use of a claimed composition only generally links the exception to the field of use. Therefore, the additional elements are not considered to amount to significantly more. Thus, the answer to Step 2B is No. Consequently, claim 60 is not directed to patent eligible subject matter.
28. Claims 61, 62, 65, and 68-73 are drawn to claim 60, wherein the one or more components (i)-(vi) are defined as follows:
Claim 61 is drawn to claim 60, wherein the composition comprises 10% (w/w) or less, 5% (w/w) or less, 2% (w/w) or less, 1% (w/w) or less, or 0.5% (w/w) or less, 0.25 % (w/w) or less, or 0.1% or less C1-C4 alcohol selected from one or more of: methanol, ethanol, propanol, butanol, including any isomers and combinations thereof.
Claim 62 is drawn to claim 60, wherein the composition is formulated as a gel comprising one or more gelator(s) selected from: polyacrylic acid/polyacrylate, 2-propeonic acid homopolymer, and Carbomer, including any combination thereof, wherein the one or more gelator(s) is provided in a concentration of 0.1-5%, 0.2-3% (w/w), 0.5-2% (w/w), 0.6-1.0 % (w/w), or around 0.8 % (w/w).
Claim 65 is drawn to claim 58, wherein the composition comprises less than 1.0, 0.5 or 0.1 % (w/w) oil.
Claim 68 is drawn to claim 60, wherein the one or more further wound healing compound(s) is or comprises hyaluronic acid or its salt; and wherein the one or more further wound healing compound(s) is provided in a concentration of 0.1-5% (w/w), 0.2-2% (w/w), 0.3-1% (w/w), 0.4-0.75% (w/w), or around 0.5 % (w/w).
Claim 69 is drawn to claim 60, wherein the one or more penetrator(s) is or comprises propylene glycol, pentylene glycol, or both propylene glycol and pentylene glycol; said propylene glycol being provided in a concentration of 0.1-60% (w/w), 5-55% (w/w), 10- 50% (w/w), 30-50% (w/w), 35-45 % (w/w), or around 30 % (w/w); and said pentylene glycol being provided in a concentration of 0.1-15% (w/w), 0.5-12% (w/w), 1.0-10% (w/w), 1.5-7.5% (w/w), 2.0-6.0 % (w/w), 2.5-4.0 % (w/w), or around 5 % (w/w).
Claim 70 is drawn to claim 60, wherein the anti-microbial agent(s) is or comprises benzalkonium chloride; and wherein the one or more anti-microbial agent(s) is provided in a concentration of 0.01-2.5% (w/w), 0.025-1.0% (w/w), 0.05-0.5% (w/w), 0.075- 0.2% (w/w), or around 0.1 % (w/w).
Claim 71 is drawn to claim 60, wherein the one or more skin moisturizer(s)/skin conditioner(s) is or comprises panthenol; and wherein panthenol is provided in a concentration of 0.1-5% (w/w), 0.15-3.0 % (w/w), 0.2-1.5% (w/w), 0.5-0.8 % (w/w), or around 0.65 % (w/w).
Claim 72 is drawn to claim 60, wherein the one or more skin moisturizer(s), skin conditioner(s), or skin moisturizer(s) and skin conditioner(s) is or comprises allantoin; and wherein allantoin is provided in a concentration of 0.01-5% (w/w), 0.05-2% (w/w), 0.1-1% (w/w), 0.2-0.5% (w/w), or around 0.3 % (w/w).
Claim 73 is drawn to claim 60, comprising:(I) a. 20-85% (w/w), 40-75% (w/w), 50-70% (w/w), 55-65% (w/w), around 61% (w/w) water; b. 0.1-60% (w/w), 5-55% (w/w), 10-50% (w/w), 30-50% (w/w), 35-45 % (w/w), or around 30 % (w/w) propylene glycol; c. 0.1-15% (w/w), 0.5-12% (w/w), 1.0-10% (w/w), 1.5-7.5% (w/w), 2.0-6.0 % (w/w), 2.5-4.0 % (w/w), or around 5 % (w/w) pentylene glycol; d. 0.1-10% (w/w), 0.2-5% (w/w), 0.4-2.0% (w/w), 0.6-1.0% (w/w), or around 0.8% (w/w) gelator(s); e. 0.1-5% (w/w), 0.15-2% (w/w), 0.2-1% (w/w), 0.25-0.75% (w/w), or around 0.5% (w/w) CBD; f. 0.1-5% (w/w), 0.15-3.0 % (w/w), 0.2-1.5% (w/w), 0.3-0.8 % (w/w), or around 0.5 % (w/w) panthenol; g. 0.1-5% (w/w), 0.2-2% (w/w), 0.3-1% (w/w), 0.4-0.75% (w/w), or around 0.5% (w/w) hyaluronic acid, hyaluronate, or hyaluronic acid and hyaluronate; h. 0.01-2.5% (w/w), 0.025-0.1.0% (w/w), 0.05-0.5% (w/w), 0.075-0.2% (w/w), or around 0.1% (w/w) benzalkonium chloride; i. 0.01-5% (w/w), 0.05-2% (w/w), 0.1-1% (w/w), 0.2-0.5% (w/w), or around 0.3 % (w/w) allantoin; and j. 0.01-2.5% (w/w), 0.025-0.1.0% (w/w), 0.05-0.5% (w/w), 0.075-0.2% (w/w), or around 0.1% (w/w) phytic acid, phytate, or phytic acid and phytate; or (II) a. 55-65% (w/w), around 61% (w/w) water b. 35-45 % (w/w), or around 30% (w/w) propylene glycol;c. 2.5-4.0 % (w/w), or around 5 % (w/w) pentylene glycol; d. 0.6-1.00% (w/w), or around 0.8% (w/w) gelator(s); e. 0.25-0.75% (w/w), or around 0.5% (w/w) CBD; f. 0.3-0.8 % (w/w), or around 0.65 % (w/w) panthenol; g. 0.4-0.75% (w/w), or around 0.5% (w/w) hyaluronic acid, hyaluronate, or hyaluronic acid and hyaluronate; h. 0.075-0.2% (w/w), or around 0.1% (w/w) benzalkonium chloride; i. 0.2-0.5% (w/w), or around 0.3 % (w/w) allantoin; and j. 0.075-0.2% (w/w), or around 0.1 (w/w) phytic acid, phytate, or phytic acid and phytate.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant’s claims 61, 62, 65, and 68-73 are directed to a product; thus, the answer to Step 1 is Yes.
The analysis then moves to Step 2A, Prong One, which asks if a claim recites a product of nature. In this case, Applicant’s claims recite the composition of claim 60, comprising cannabidiol, water, and one or more terpenes, which are all naturally occurring, in combination with at least one component of (i)-(vi) recited by claim 60. As the composition of claim 58 comprising cannabidiol, water, and at least one penetrator such as a terpene can exist naturally within a cannabis plant, the claim does recite a product of nature. MPEP § 2106.04(b) states that “When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A.”
MPEP § 2106.04(c)(I) states that “if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception…”. To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states “The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties…”.
In this case, cannabidiol, water, and one or more terpene penetrator(s) naturally occur in a cannabis plant. Thus, the closest naturally occurring counterpart for the claimed composition is cannabis itself. Thus, the claimed composition reads directly on the cannabis plant itself. Thus, there is not considered to be a marked distinction between the claimed product and naturally occurring cannabidiol, water, and one or more terpene penetrators. Thus, the claimed composition as a whole does not display markedly different characteristics in comparison with the naturally occurring counterparts. Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. In this case, applicant’s claims are directed to a composition with an intended use of topical application for wound treatment. MPEP § 2106.04(d)(2) specifically states that a claim is only directed to “an intended use of a claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the ‘treatment or prophylaxis’ consideration.” Therefore, applicant’s intended use is not sufficient to integrate the judicial exception into a practical application. Thus, the answer to Step 2A, Prong Two, is No.
Thus, the analysis must move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by “Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself.” In this case, claim recites additional elements comprising at least one gelator, at least one skin moisturizer and/or skin conditioner, at least one further wound healing compound, and at least one antimicrobial agent, at least on pH stabilizer, and/or at least one chelating agent. However, MPEP § 2106.05(d) states that well-understood, routine, and conventional activities are not sufficient to show that the claims amount to significantly more than the judicial exception. Mixing the naturally occurring cannabidiol composition of claims 58 and 60 with each of the specific compounds of claims 61, 62, 65, and 68-73 does not amount to significantly more than a combination of judicial exception because mixing compounds is well-understood, routine, and conventional in the field (see Henriksen et al., Examples 1 and 2). Thus, combining the cannabidiol composition of claim 60 with at least one additional component of claims 61, 62, 65, and 68-73, does not amount to significantly more than a combination of judicial exception because mixing compounds is well-understood, routine, and conventional in the field.
In addition, applicant’s intended use of topical application for wound treatment is not considered to amount to significantly more. As discussed in MPEP § 2106.05(I)(A), “Generally linking the use of the judicial exception to a particular technological environment or field of use” is not considered to be enough to qualify as significantly more. An intended use of a claimed composition only generally links the exception to the field of use. Therefore, the additional elements are not considered to amount to significantly more. Thus, the answer to Step 2B is No. Consequently, claims 61, 62, 65, and 68-73 are not directed to patent eligible subject matter.
29. Claim 63 is drawn to claim 60, wherein the composition has a pH of 6.5 ± 0.25, 6.25 ± 0.25, or 6.0 ±0.25.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant’s claim 58 is directed to a product; thus, the answer to Step 1 is Yes.
The analysis then moves to Step 2A, Prong One, which asks if a claim recites a product of nature. In this case, Applicant’s claim recites the composition of claim 60 comprising:
(a) cannabidiol (CBD)
(b) water;
(c) one or more penetrator(s),
one or more additional components selected from (i)-(vi),
and further limits the pH.
Cannabidiol, water, one or more terpenes that are naturally occurring permeation enhancers, and an additional component of claim 60 can be found in cannabis plants, as described above (see Chen et al., and the webpage printout of The Semi-Complete List Of Cannabis Terpenes | The Healing Clinics Medical Marijuana Doctors). Thus, the claim does recite a product of nature. MPEP § 2106.04(b) states that “When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A.”
MPEP § 2106.04(c)(I) states that “if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception…”. To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states “The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties…”.
In this case, cannabidiol, water, and one or more terpene penetrator(s) naturally occur in a cannabis plant. Thus, the closest naturally occurring counterpart for the claimed composition is cannabis itself. Thus, the claimed composition reads directly on the cannabis plant itself. Thus, there is not considered to be a marked distinction between the claimed product and naturally occurring cannabidiol, water, and one or more terpene penetrators. Thus, the claimed composition as a whole does not display markedly different characteristics in comparison with the naturally occurring counterparts. Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. In this case, applicant’s claims are directed to a composition with an intended use of topical application for wound treatment. MPEP § 2106.04(d)(2) specifically states that a claim is only directed to “an intended use of a claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the ‘treatment or prophylaxis’ consideration.” Therefore, applicant’s intended use is not sufficient to integrate the judicial exception into a practical application. Thus, the answer to Step 2A, Prong Two, is No.
Thus, the analysis must move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by “Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself.” In this case, the additional element in the claims is the recitation of the pH. However, MPEP § 2106.05(d) states that well-understood, routine, and conventional activities are not sufficient to show that the claims amount to significantly more than the judicial exception. Determining pH of a cannabidiol composition does not amount to significantly more than a combination of judicial exception because pH is well-understood, routine, and conventional in the field (see Henriksen et al., page 13, lines 13-17). Thus, determining the pH of the composition of claim 58 does not amount to significantly more than a combination of judicial exception because mixing compounds is well-understood, routine, and conventional in the field
In addition, applicant’s intended use of topical application for wound treatment is not considered to amount to significantly more. As discussed in MPEP § 2106.05(I)(A), “Generally linking the use of the judicial exception to a particular technological environment or field of use” is not considered to be enough to qualify as significantly more. An intended use of a claimed composition only generally links the exception to the field of use. Therefore, the additional elements are not considered to amount to significantly more. Thus, the answer to Step 2B is No. Consequently, claim 63 is not directed to patent eligible subject matter.
30. Claim 64 is drawn to claim 58, wherein the composition is not formulated as an oil-in-water emulsion or water-in-oil emulsion.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant’s claim 58 is directed to a product; thus, the answer to Step 1 is Yes.
The analysis then moves to Step 2A, Prong One, which asks if a claim recites a product of nature. In this case, Applicant’s claim recites the composition of claim 58 comprising by weight:
(a) 0.1-5%, 0.2-2%, 0.3-1%, 0.4-0.75%, or around 0.5% (w/w) cannabidiol (CBD)
(b) 25-85%, 35-75%, 45-70% or 55-65% (w/w) water; and
(c) one or more penetrator(s),
which is not formulated as an oil-in-water emulsion or water-in-oil emulsion.
Cannabidiol, water, and one or more naturally occurring terpenes can be found in cannabis plants (see Chen et al., and the webpage printout of The Semi-Complete List Of Cannabis Terpenes | The Healing Clinics Medical Marijuana Doctors). Thus, the claim does recite a product of nature. MPEP § 2106.04(b) states that “When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A.”
MPEP § 2106.04(c)(I) states that “if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception…”. To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states “The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties…”.
In this case, a composition comprising the natural products cannabidiol, water, and one or more terpene penetrator(s), wherein the composition is not an oil-in-water or water-in-oil emulsion, naturally occur in a cannabis plant. Thus, the closest naturally occurring counterpart for the claimed composition is cannabis itself. Thus, the claimed composition reads directly on the cannabis plant itself. Thus, there is not considered to be a marked distinction between the claimed product and naturally occurring cannabidiol, water, and one or more terpene penetrators, that is not an oil-in-water or water-in-oil emulsion. Thus, the claimed composition as a whole does not display markedly different characteristics in comparison with the naturally occurring counterparts. Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. In this case, applicant’s claims are directed to a composition with an intended use of topical application for wound treatment. MPEP § 2106.04(d)(2) specifically states that a claim is only directed to “an intended use of a claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the ‘treatment or prophylaxis’ consideration.” Therefore, applicant’s intended use is not sufficient to integrate the judicial exception into a practical application. Thus, the answer to Step 2A, Prong Two, is No.
Thus, the analysis must move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by “Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself.” In this case, claim does not recite additional elements.
In addition, applicant’s intended use of topical application for wound treatment is not considered to amount to significantly more. As discussed in MPEP § 2106.05(I)(A), “Generally linking the use of the judicial exception to a particular technological environment or field of use” is not considered to be enough to qualify as significantly more. An intended use of a claimed composition only generally links the exception to the field of use. Therefore, the additional elements are not considered to amount to significantly more. Thus, the answer to Step 2B is No. Consequently, claim 64 is not directed to patent eligible subject matter.
31. Claims 66 and 67 are drawn to claim 58, further comprising one or more cannabinoids:
Claim 66 is drawn to claim 58, wherein the composition comprises one or more further cannabinoid(s) selected from one or more of: THC (tetrahydrocannabinol), THCA (tetrahydrocannabinolic acid), CBDA (cannabidiolic acid), CBN (cannabinol), CBG (cannabigerol), CBC (cannabichromene), CBL (cannabicyclol), CBV (cannabivarin), THCV (tetrahydrocannabivarin), THCP (tetrahydrocannabiphorol), CBDV (cannabidivarin), CBCV (cannabichromevarin), CBGV (cannabigerovarin), CBGM (cannabigerol monomethyl ether), CBE (cannabielsoin), and CBT (cannabicitran), including any combination(s) thereof.
Claim 67 is drawn to claim 59, wherein the composition comprises less than 1.5, 1.0, 0.5 or 0.1% (w/w) of one or more further cannabinoid(s) selected from one or more of: THC, THCA, CBDA, CBN, CBG, CBC, CBL, CBV, THCV, THCP, CBDV, CBCV, CBGV, CBGM, CBE, CBT, or any combination thereof.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant’s claims 66 and 67 are directed to a product; thus, the answer to Step 1 is Yes.
The analysis then moves to Step 2A, Prong One, which asks if a claim recites a product of nature. In this case, Applicant’s claims recite the composition of claims 58 or 59, comprising cannabidiol, water, and one or more terpenes, which are all naturally occurring, as well at least one further cannabinoid. BiologyInsights.com (webpage printout of List of Cannabinoids and Their Effects - Biology Insights, July 30, 2025) teaches the therapeutic effects of other plant-derived cannabinoids derived from the cannabis plant: e.g., THC, CBD, CBG, CBN, CBC, THCV, and CBDV (see pages 1-2). Thus, the claims do recite a product of nature. MPEP § 2106.04(b) states that “When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A.”
MPEP § 2106.04(c)(I) states that “if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception…”. To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states “The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties…”. In this case, cannabidiol, water, one or more terpene penetrator(s), and additional cannabinoids including THC, CBD, CBG, CBN, CBC, THCV, and CBDV, naturally occur in a cannabis plant. Thus, the closest naturally occurring counterpart for the claimed composition is cannabis itself. Thus, the claimed composition reads directly on the cannabis plant itself. Thus, there is not considered to be a marked distinction between the claimed product and naturally occurring cannabidiol, water, and one or more terpene penetrators. Thus, the claimed composition as a whole does not display markedly different characteristics in comparison with the naturally occurring counterparts. Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. In this case, applicant’s claims are directed to a composition with an intended use of topical application for wound treatment. MPEP § 2106.04(d)(2) specifically states that a claim is only directed to “an intended use of a claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the ‘treatment or prophylaxis’ consideration.” Therefore, applicant’s intended use is not sufficient to integrate the judicial exception into a practical application. Thus, the answer to Step 2A, Prong Two, is No.
Thus, the analysis must move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by “Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself.” In this case, claim recites additional elements comprising at least one cannabinoid selected from THC, THCA, CBDA, CBN, CBG, CBC, CBL, CBV, THCV, THCP, CBDV, CBCV, CBGV, CBGM, CBE, CBT, which are also naturally occurring products found in a cannabis plant. However, MPEP § 2106.05(d) states that well-understood, routine, and conventional activities are not sufficient to show that the claims amount to significantly more than the judicial exception. The addition of the naturally occurring components/ cannabinoids already present in cannabis itself does not amount to significantly more than a combination of judicial exception because said cannabinoid components are well-understood, routine and conventional in the field (as taught by BiologyInsights, above). Thus, combining the CBD composition of claim 58 with an additional natural product such as THC, CBD, CBG, CBN, CBC, THCV, and CBDV, also found in cannabis, does not amount to significantly more than a combination of judicial exception because mixing compounds is well-understood, routine, and conventional in the field.
In addition, applicant’s intended use of topical application for wound treatment is not considered to amount to significantly more. As discussed in MPEP § 2106.05(I)(A), “Generally linking the use of the judicial exception to a particular technological environment or field of use” is not considered to be enough to qualify as significantly more. An intended use of a claimed composition only generally links the exception to the field of use. Therefore, the additional elements are not considered to amount to significantly more. Thus, the answer to Step 2B is No. Consequently, claims 66 and 67 are not directed to patent eligible subject matter.
32. Claim 79 is drawn to a kit comprising an instruction for use and a receptacle comprising a wound treatment composition according to claim 60, said receptacle providing light and UV protection to the wound treatment composition
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant’s claim 58 is directed to a kit (a product); thus, the answer to Step 1 is Yes.
The analysis then moves to Step 2A, Prong One, which asks if a claim recites a product of nature. In this case, Applicant’s claim recites the composition of claim 60 comprising:
(a) cannabidiol (CBD)
(b) water;
(c) one or more penetrator(s),
one or more additional components selected from (i)-(vi),
and an instruction for use and a receptacle.
Cannabidiol, water, one or more terpenes that are naturally occurring permeation enhancers, and an additional component of claim 60 can be found in cannabis plants, as described above (see Chen et al., and the webpage printout of The Semi-Complete List Of Cannabis Terpenes | The Healing Clinics Medical Marijuana Doctors). Thus, the claim does recite a product of nature. MPEP § 2106.04(b) states that “When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A.”
MPEP § 2106.04(c)(I) states that “if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception…”. To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states “The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties…”.
In this case, cannabidiol, water, and one or more terpene penetrator(s) naturally occur in a cannabis plant. Thus, the closest naturally occurring counterpart for the claimed composition is cannabis itself. Thus, the claimed composition reads directly on the cannabis plant itself. Thus, there is not considered to be a marked distinction between the claimed product and naturally occurring cannabidiol, water, and one or more terpene penetrators. Thus, the claimed composition as a whole does not display markedly different characteristics in comparison with the naturally occurring counterparts. Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. In this case, applicant’s claims are directed to a composition with the intended use of an instruction. MPEP § 2106.04(d)(2) specifically states that a claim is only directed to “an intended use of a claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the ‘treatment or prophylaxis’ consideration.” Therefore, applicant’s intended use is not sufficient to integrate the judicial exception into a practical application. Thus, the answer to Step 2A, Prong Two, is No.
Thus, the analysis must move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by “Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself.” In this case, the additional element in the claims is an instruction and a receptable. However, MPEP § 2106.05(d) states that well-understood, routine, and conventional activities are not sufficient to show that the claims amount to significantly more than the judicial exception. A kit comprising the natural product cannabidiol composition of claim 60, an instruction for use and a receptable for said composition does not amount to significantly more than a combination of judicial exception because providing said composition in receptacle in a kit with an instruction is well-understood, routine, and conventional in the field (see Henriksen et al., page 22, lines 11-19). Thus, the recitation of the kit of claim 60 does not amount to significantly more than a combination of judicial exception because providing said naturally occurring composition in a receptacle with an instruction is well-understood, routine, and conventional in the field.
In addition, applicant’s intended use of wound treatment is not considered to amount to significantly more. As discussed in MPEP § 2106.05(I)(A), “Generally linking the use of the judicial exception to a particular technological environment or field of use” is not considered to be enough to qualify as significantly more. An intended use of a claimed composition only generally links the exception to the field of use. Therefore, the additional elements are not considered to amount to significantly more. Thus, the answer to Step 2B is No. Consequently, claim 79 is not directed to patent eligible subject matter.
Claim Rejections - 35 USC § 102
32. 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
33. Claims 58-61, 62, 64, 65, 71 and 79 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Henriksen et al., WO 2021023351 A (published February 11, 2021, cited on Applicant’s IDS of April 21, 2026).
Claim 58 is drawn to a composition formulated as a wound treatment composition for topical application comprising by weight:
a) 0.1-5%, 0.2-2%, 0.3-1%, 0.4-0.75%, or around 0.5% (w/w) cannabidiol (CBD); b) 25-85 %, 35-75 %, 45-70 % or 55-65 % (w/w) water; and
c) one or more penetrator(s), and
further comprising one or more components selected from:
i. One or more gelator(s);
ii. One or more skin moisturizer(s), skin conditioner(s), or skin moisturizer(s) and skin conditioner(s);
iii. One or more further wound healing compound(s);
iv. One or more anti-microbial agent(s);
v. One or more pH stabilizer(s); and
vi. One or more chelating agent(s); or
vii. any combination(s) of (i)-(vi)
(claim 60).
Claim 59 is drawn to claim 58, and limits wherein the CBD used in the provision of the CBD-comprising composition has a purity of at least 95 % (w/w), 98% (w/w), 99% (w/w), 99.5 (w/w), or more than 99.8% (w/w) and is crystalline; and wherein the CBD crystals are selected from one or more of:
needle-like crystals; crystals not provided by an extraction method comprising critical CO2 extraction; and crystals provided by a method comprising extraction with a C3-C4 alcohol, and one or more crystallisation steps with a C6-C8 alcohol; or any combination thereof.
34. Henriksen et al. teach the hydroalcoholic composition of Example 1 for topical application comprising:
(a) Cannabidiol (CBD) crystalline powder in 98% purity, in an amount of 2.0 g/ 100 g, or 2.0 % w/w,
(b) demineralized water in an amount of 55.2 g/100 g, or 55.2 % w/w, which is within the range of 25-85 %, 35-75 %, 45-70 % or 55-65 % (w/w) required by claim 1,
(c) the penetrator isopropyl myristate in an amount of 0.9%, and
additional components:
(ii) the skin moisturizer/ condition Panthenol in an amount of 2.75 g/100 g or 2/75% w/w,
(iii) the wound healing compound tocopheryl acetate (Henriksen et al. evidence that tocopheryl acetate is a wound healing compound: “Further, tocopherol aetate is known to provide improved wound healing and reduces formation of scar tissue when applied topically,” ), and
(v) Henriksen et al. teach the pH stabilizer sodium hydroxide (NaOH) in the composition of Example 1, (Henriksen et al. evidence that alkaline pH regulators include sodium hydroxide) (see pages 23-24).
35. Henriksen et al. additionally teach the hydroalcoholic composition of Example 2 for topical application comprising:
(a) (Cannabidiol (CBD) ) crystalline powder in 98% purity, in an amount of 1.0 g/ 100 g, or 1.0 % w/w,
(b) demineralized water in an amount of 68.34 g/100 g, or 68.34 % w/w, which is within the range of 25-85 %, 35-75 %, or 45-70 % (w/w) required by claim 1,
(c) the penetrator isopropyl myristate in an amount of 0.9%,
(i) the gelator (gelling agent) Lubrizol/Carbopol® Ultrez 20 (aka the tradename for an acrylate copolymer,
(v) Henriksen et al. teach the pH stabilizer sodium hydroxide (NaOH) in the composition of Example 2 (see pages 24-25).
(Henriksen et al. evidence that alkaline pH regulators include commonly used water soluble and non-toxic bases, such as e.g. sodium hydroxide or potassium hydroxide, (page 13, lines 10-11).
36. Regarding the preamble statement reciting the composition is “formulated as a wound treatment composition for topical application” in line 1 of claim 58, a “mere statement of a new use for an otherwise old or obvious composition cannot render a claim to the composition patentable.” In re Zierden, 411 F.2d 1325, 1328 (CCPA 1969). Rather, “‘a preamble is not limiting “where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention.’” Catalina Marketing Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002). Therefore the preamble of claim 58 does not impose any limitation on the product claim.
37. Regarding the recited purity of CBD in claim 59, the compositions of Example 1 and Example 2 comprise 98% pure crystalline CBD powder, which meets the limitation of at least 95 % (w/w), or at least 98% (w/w), required by claim 59. Henriksen et al. do not disclose that the crystals are provided by a critical CO2 extraction method, which meets the limitation of claim 59.
As such, claims 58-60 are anticipated.
Claim 62 is drawn to claim 60, and limits wherein the composition is formulated as a gel comprising one or more gelator(s) selected from: polyacrylic acid/polyacrylate, 2-propeonic acid homopolymer, and Carbomer, including any combination thereof, wherein the one or more gelator(s) is provided in a concentration of 0.1-5%, 0.2-3% (w/w), 0.5-2% (w/w), 0.6-1.0 % (w/w), or around 0.8 % (w/w).
38. Henriksen et al. teach that the hydroalcoholic gel composition of Example 2 contains Lubrizol/Carbopol® Ultrez 20 (aka the tradename for an acrylate copolymer) in an amount of 1.0 g/ 100 g or 1% w/w, which meets the limitation of 0.1-5%, 0.2-3% (w/w), 0.5-2% (w/w), 0.6-1.0 % (w/w), required by claim 62.
As such, claim 62 is anticipated.
Claim 64 is drawn to claim 58, and limits wherein the composition is not formulated as an oil-in-water emulsion or water-in-oil emulsion. Claim 65 is drawn to claim 58, and limits wherein the composition comprises less than 1.0, 0.5 or 0.1 % (w/w) oil.
39. The hydroalcoholic gel compositions of Examples 1 and 2 disclosed by Henriksen et al. are not oil-in-water emulsions or water-in-oil emulsions, which meets the limitation of claim 64. The hydroalcoholic gel compositions of Examples 1 and 2 disclosed by Henriksen et al. do not comprise oil, which meets the limitation of comprising less than 1.0, 0.5 or 0.1 % (w/w) oil required by claim 65.
As such, claims 64 and 65 are anticipated.
Claim 71 is drawn to claim 60, and limits wherein the one or more skin moisturizer(s)/skin conditioner(s) is or comprises panthenol; and wherein panthenol is provided in a concentration of 0.1-5% (w/w), 0.15-3.0 % (w/w), 0.2- 1.5% (w/w), 0.5-0.8 % (w/w), or around 0.65 % (w/w).
40. Henriksen et al. additionally teach that the hydroalcoholic gel composition of Example 1 contains Panthenol in an amount of 2.75 g/100 g or 2.75% w/w, which meets the limitation of 0.1-5% (w/w) or 0.15-3.0 % (w/w), required by claim 71.
As such, claim 71 is anticipated.
Claim 79 is drawn to a kit comprising an instruction for use and a receptacle comprising a wound treatment composition according to claim 60, said receptacle providing light and UV protection to the wound treatment composition.
41. Henriksen et al. additionally teach a kit comprising an instruction for use and a container: “a composition as disclosed herein is part of a kit, comprising an instruction for use, such as an instruction for use disclosed in Example 11 or 12. Often, the composition is packaged in a suitable container, such as a container that can be opened and closed repeatedly or a single use container. In some embodiments, the container is a single use container, such as a sealed bag. In some embodiments, the container is a glass or plastic containers with a lid. In some embodiments, the container is a tube, such as a squeeze and/or collapsible, or another collapsible package known in the art. In some embodiments, a composition as disclosed herein is provided in a container, such as a kit, which may also comprise an instruction for use.” (page 22, lines 11-19). Therefore the limitation of a kit comprising an instruction for use and a receptable are anticipated by Henriksen et al.
Further, the recitation of the instructions is given no patentable weight for the following reasons, the printed matter on a label or package insert of a kit or container does not lend patentable weight as a limitation of the claimed product, composition, or article of manufacture, absent a functional relationship between the label or package insert of a kit and the product, composition, or article of manufacture of a kit or container. See In re Haller 73 USPQ 403 (CCPA 1947), where it is held that application of printed matter to old article cannot render the article patentable. In the opinion text of In re Haller, it is stated that: Whether the statement of intended use appears merely in the claim or in label on the product is immaterial so far as the question of Patentability is concerned. . . In accordance with the patent statutes, an article or composition of matter, in order to patentable, must not only be useful and involve invention, but must also be new. If there is no novelty in an article or composition itself, then a patent cannot be properly granted on the article or composition, regardless of the use for which it is intended. The difficulty is not that there can never be invention in discovering a new process involving the use of an old article, but that the statutes make no provision for patenting of an article or composition which is not, in and of itself, new.
42. And regarding the receptacle “providing light and UV protection to the wound treatment composition,” the function of the receptable also constitutes an “intended use” for that product/kit or article of manufacture. Intended use does not impart patentable weight to a product. See MPEP 2111.03: Intended use recitations and other types of functional language cannot be entirely disregarded. However, in apparatus, article and composition claims, intended use must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In a claim drawn to a process of making, the intended use must result in a manipulative difference as compared to the prior art. In re Casey, 370 F.2d 576, 152 USPQ 235 (CCPA 1967); In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963). In this case, the receptable or container taught by Henriksen et al. is capable of performing the function of protecting the composition from light and UV.
Therefore claim 79 is anticipated.
Claim Rejections - 35 USC § 103
43. 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.
44. 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.
45. Claims 61, 63, 66, and 67 are rejected under 35 U.S.C. 103 as being unpatentable over Henriksen et al., WO 2021023351 A, as applied to claims 58-60, 62, 64, 65, and 71, above.
Claims 58-60 are addressed in detail, above.
Claim 61 is drawn to claim 60, and limits wherein the composition comprises 10% (w/w) or less, 5% (w/w) or less, 2% (w/w) or less, 1% (w/w) or less, or 0.5% (w/w) or less, 0.25 % (w/w) or less, or 0.1% or less C1-C4 alcohol selected from one or more of: methanol, ethanol, propanol, butanol, including any isomers and combinations thereof.
46. Henriksen et al. disclose the hydroalcoholic composition of Example 1 comprising:
(a) (Cannabidiol (CBD) ) crystalline powder in 98% purity, in an amount of 2 % w/w,
(b) demineralized water in an amount of 55.2 % w/w,
(c) the penetrator isopropyl myristate in an amount of 0.9%, and
components (i) and (v) of claim 60, and
Ethanol, (pages 23-25).
47. Henricksen et al. do not disclose in the exemplified composition wherein the amount of ethanol is 10% (w/w) or less, 5% (w/w) or less, 2% (w/w) or less, 1% (w/w) or less, or 0.5% (w/w) or less, 0.25 % (w/w) or less, or 0.1% or less.
48. Yet, Henriksen et al. teach that the composition of Example 1 comprises ethanol in an amount of 15 g/100 g or 15% w/w. And, Henriksen et al. teach alternative preferred hydroalcoholic CBD compositions comprising ethanol in an amount of 10-30% (pages 16-17). Thus it would have been obvious for one skilled in the art before the effective filing date of the claimed invention to start with the about of 15% w/w ethanol and optimize this amount in the same composition taught by Henriksen et al., with a reasonable expectation of success. And, optimization of parameters is a that would be obvious for a person of ordinary skill in the art to employ. It would have been a routine practice for one skilled in the art before the effective filing date of the claimed invention to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect.
As such, claim 61 is prima facie obvious.
Claim 63 is drawn to claim 60, and limits wherein the composition has a pH of 6.5 ± 0.25, 6.25 ± 0.25, or 6.0 ± 0.25.
49. Henriksen et al. disclose the hydroalcoholic compositions of Example 1 and Example 2 comprising:
(a) (Cannabidiol (CBD) ) crystalline powder in 98% purity,
(b) demineralized water,
(c) the penetrator isopropyl myristate, and
one or more components of claim 60,
but do not specify the pH of said compositions.
However, Henriksen et al. additionally teach that: “[p]referably, pH in the hydroalcoholic gel is 5-9, or preferably 6-8.5. In some embodiments, the pH of the gel mimics the pH of the skin, such as a slightly acidic pH. Thus in some embodiments, the pH is 4.5-6.5. In some embodiments, the pH of the hydroalcoholic gel is 4.5-5.5, 5.0-6.0, 5.5-6.5, 6.0-7.0, 6.5-7.5, 7.0-8.0, 7.5-8.5, or 8.0- 9.0,” which meets the limitation of “6.5 ± 0.25, 6.25 ± 0.25, or 6.0 ± 0.25” required by claim 63 (see page 13, lines 13-17). Thus it would have been obvious for one skilled in the art before the effective filing date of the claimed invention to formulate the compositions of Example 1 or Example 2 with a pH of 6.5 ± 0.25, 6.25 ± 0.25, or 6.0 ± 0.25, with a reasonable expectation of success.
As such, claim 63 is prima facie obvious.
Claim 66 is drawn to claim 58, wherein the composition comprises one or more further cannabinoid(s) selected from one or more of: THC (tetrahydrocannabinol), THCA (tetrahydrocannabinolic acid), CBDA (cannabidiolic acid), CBN (cannabinol), CBG (cannabigerol), CBC (cannabichromene), CBL (cannabicyclol), CBV (cannabivarin), THCV (tetrahydrocannabivarin), THCP (tetrahydrocannabiphorol), CBDV (cannabidivarin), CBCV (cannabichromevarin), CBGV (cannabigerovarin), CBGM (cannabigerol monomethyl ether), CBE (cannabielsoin), and CBT (cannabicitran), including any combination(s) thereof. Claim 67 is drawn to claim 59, wherein the composition comprises less than 1.5, 1.0, 0.5 or 0.1% (w/w) of one or more further cannabinoid(s) selected from one or more of: THC, THCA, CBDA, CBN, CBG, CBC, CBL, CBV, THCV, THCP, CBDV, CBCV, CBGV, CBGM, CBE, CBT, or any combination thereof.
50. Henriksen et al. teach the hydroalcoholic compositions of Example 1 and Example 2 comprising:
(a) (Cannabidiol (CBD) ) crystalline powder in 98% purity,
(b) demineralized water,
(c) the penetrator isopropyl myristate, and
one or more components of claim 60,
but do not explicitly disclose comprises one or more further cannabinoid(s) in said compositions.
51. Yet, in Table B, Henriksen et al. teach the presence of related substances in the 98% pure crystalline powder, specifically other cannabinoids: CBDV in an amount of less than or equal to 1.5 % w/w, CBDA in an amount of less than or equal to 1.5 % w/w, CBG in an amount of less than or equal to 1.5 % w/w, CBN in an amount of less than or equal to 1.5 % w/w, and THC in an amount of less than or equal to 0.1 % w/w, which meets the limitations of claims 66 and 67 (Table B, pages 13-14).
52. Thus it would have been obvious for one skilled in the art before the effective filing date of the claimed invention to formulate the compositions of Example 1 or Example 2 wherein the composition comprises less than 1.5 % of CBDV, CBDA, CBG, CBN and/or less than 0.1% THC, with a reasonable expectation of success.
As such, claims 66 and 67 are prima facie obvious.
53. Claims 68, 69, and 72 are rejected under 35 U.S.C. 103 as being unpatentable over Henriksen et al., WO 2021023351 A, as applied to claims 58-60, 61-67 and 71, above, and further in view of Lurya et al., U.S. 20200345657 A1 (cited on Applicant’s IDS of April 21, 2026).
Claim 60 is addressed in detail, above.
Claim 68 is drawn to claim 60, wherein the one or more further wound healing compound(s) is or comprises hyaluronic acid or its salt; and wherein the one or more further wound healing compound(s) is provided in a concentration of 0.1-5% (w/w), 0.2-2% (w/w), 0.3-1% (w/w), 0.4-0.75% (w/w), or around 0.5 % (w/w).
Claim 72 is drawn to claim 60, wherein the one or more skin moisturizer(s), skin conditioner(s), or skin moisturizer(s) and skin conditioner(s) is or comprises allantoin; and wherein allantoin is provided in a concentration of 0.01-5% (w/w), 0.05-2% (w/w), 0.1-1% (w/w), 0.2-0.5% (w/w), or around 0.3 % (w/w).
29.
54. Henriksen et al. disclose the topical hydroalcoholic gel compositions of Example 1 and Example 2 comprising:
(a) (Cannabidiol (CBD) ) crystalline powder in 98% purity,
(b) demineralized water,
(c) a penetrator, and
one or more components of claim 60, including (ii) a skin moisturizer or conditioner, and (iii) a wound healing compound,
but do not teach the inclusion of allantoin or hyaluronic acid.
55. Yet, Lurya et al. teach a topical gel composition for pain relief comprising (a) CBD, (b) Water, (c) a penetrating enhancer, (ii) allantoin in an amount of 0.15% w/w (which meets the limitation of 0.01-5% (w/w), 0.05-2% (w/w), or 0.1-1% (w/w) required by claim 72), and (iii) sodium hyaluronate in an amount of 0.5% w/w (sodium hyaluronate is the salt form of hyaluronic acid), which meets the limitation of 0.1-5% (w/w), 0.2-2% (w/w), 0.3-1% (w/w), 0.4-0.75% (w/w), or around 0.5 % (w/w) required by claim 68.
56. Thus it would have been obvious for one skilled in the art before the effective filing date of the claimed invention to combine the topical gel CBD formulations of Henriksen et al. with components from the topical gel CBD formulation taught by Lurya et al., incorporating the skin moisturizer allantoin and the wound healing compound sodium hyaluronate, with a reasonable expectation of success.
57. The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law, please see In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988); In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992). See also In re Kotzab, 217 F.3d 1365, 1370, 55 USPQ2d 1313, 1317 (Fed. Cir. 2000) (setting forth test for implicit teachings); In re Eli Lilly & Co., 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) (discussion of reliance on legal precedent); In re Nilssen, 851 F.2d 1401, 1403, 7 USPQ2d 1500, 1502 (Fed. Cir. 1988) (references do not have to explicitly suggest combining teachings). Furthermore, MPEP 2144 teaches that the strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination. Please refer to MPEP 2144.06 “I. COMBINING EQUIVALENTS KNOWN FOR THE SAME PURPOSE” wherein Kerkhoven is specifically referenced:
“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.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious).
As stated by the Court in KSR International Co., v. Teleflex Inc., 127 US 1727 (2007), “when a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious” (quoting Sakraida v. AG Pro, Inc., 425 US 273 (1976).
As such, claims 68 and 72 are prima facie obvious.
Claim 69 is drawn to claim 60, wherein the one or more penetrator(s) is or comprises propylene glycol, pentylene glycol, or both propylene glycol and pentylene glycol; said propylene glycol being provided in a concentration of 0.1-60% (w/w), 5-55% (w/w), 10- 50% (w/w), 30-50% (w/w), 35-45 % (w/w), or around 30 % (w/w); and said pentylene glycol being provided in a concentration of 0.1-15% (w/w), 0.5-12% (w/w), 1.0-10% (w/w), 1.5-7.5% (w/w), 2.0-6.0 % (w/w), 2.5-4.0 % (w/w), or around 5 % (w/w).
58. Henriksen et al. disclose the topical hydroalcoholic gel compositions of Example 1 and Example 2 comprising:
(a) (Cannabidiol (CBD) ) crystalline powder in 98% purity,
(b) demineralized water,
(c) a penetrator, and
one or more components of claim 60, including (ii) a skin moisturizer or conditioner, and (iii) a wound healing compound,
but do not teach the inclusion of the penetrator propylene glycol, pentylene glycol or a combination thereof.
59. Yet, Lurya et al. teach a topical gel composition for pain relief comprising (a) CBD, (b) Water, and 45% propylene glycol in the topical CBD formulation for pain relief:
“According to a further aspect is a method for providing lubrication and pain relief and/or a feeling of well-being to a mucosal surface, the method comprising applying a lubricant comprising a cannabinoid stock comprising or consisting of a lipid phase of up to about 10% by weight CBD, about 45% by weight phosphatidylcholine, about 45% by weight propylene glycol and about 0.2% by weight vitamin E/TPGS, to the mucosal surface.” (see paragraph [0069]).
60. “About 45% by weight propylene glycol” meets the limitation of propylene glycol provided in a concentration of 0.1-60% (w/w), 5-55% (w/w), 10- 50% (w/w), 30-50% (w/w), 35-45 % (w/w), required by claim 37. Thus it would have been obvious for one skilled in the art before the effective filing date of the claimed invention to combine the topical gel CBD formulations of Henriksen et al. with components from the topical gel CBD formulation taught by Lurya et al., incorporating the penetrator propylene glycol in an amount of 45% w/w, with a reasonable expectation of success.
As such, claim 69 is prima facie obvious.
61. Claims 70 and 73 are rejected under 35 U.S.C. 103 as being unpatentable over Henriksen et al., WO 2021023351 A, as applied to claims 58-60, 61-67 and 71, above, and further in view of Lurya et al., U.S. 20200345657 A1 (cited on Applicant’s IDS of April 21, 2026), and Stinchcomb et al., WO 2010127033 A1.
Claim 60 is addressed in detail, above.
Claim 70 is drawn to claim 60, wherein the anti-microbial agent(s) is or comprises benzalkonium chloride; and wherein the one or more anti-microbial agent(s) is provided in a concentration of 0.01-2.5% (w/w), 0.025-1.0% (w/w), 0.05-0.5% (w/w), 0.075- 0.2% (w/w), or around 0.1 % (w/w).
62. Henriksen et al. disclose the topical hydroalcoholic gel compositions of Example 1 and Example 2 comprising:
(a) (Cannabidiol (CBD) ) crystalline powder in 98% purity,
(b) demineralized water,
(c) a penetrator,
ethanol, and
one or more components of claim 60,
but do not teach the inclusion of (iv) the antimicrobial compound.
63. Yet, Stinchcomb et al. teach a topical gel composition for pain relief comprising (a) CBD, (b) Water, ethanol, propylene glycol in a topical CBD formulation for pain relief, and suggest the inclusion of an antimicrobial:
“In one embodiment, the compositions described herein comprise an antimicrobial preservative. Illustrative anti-microbial preservatives include acids, including but not limited to benzoic acid, phenolic acid, sorbic acids, alcohols, benzethonium chloride, bronopol, butylparaben, cetrimide, chlorhexidine, chlorobutanol, chlorocresol, cresol, ethylparaben, imidurea, methylparaben, phenol, phenoxyethanol, phenylethyl alcohol, phenylmercuric acetate, phenylmercuric borate, phenylmercuric nitrate, potassium sorbate, propylparaben, sodium propionate, or thimerosal. The anti-microbial preservative, if present, is present in an amount by weight of the composition of about 0.1% to about 5%, about 0.2% to about 3%, or about 0.3% to about 2%, for example about 0.2%, about 0.4%, about 0.6%, about 0.8%, about 1%, about 1.2%, about 1.4%, about 1.6%, about 1.8%, about 2%, about 2.2%, about 2.4%, about 2.6%, about 2.8%, about 3.0%, about 3.2%, about 3.4%, about 3.6%, about 3.8%, about 4%, about 4.2%, about 4.4%, about 4.6%, about 4.8%, or about 5%.” (see paragraph [0080]).
Stinchcomb et al. name additional quaternary ammonium preservatives including benzalkonium chloride in paragraph [0075].
64. Thus it would have been obvious for one skilled in the art before the effective filing date of the claimed invention to combine the topical gel CBD formulation of Henriksen et al. with the topical gel CBD formulation taught by Lurya et al., incorporating the antimicrobial component benzalkonium chloride in an amount of 0.01-2.5% (w/w), 0.025-0.1.0% (w/w), 0.05-0.5% (w/w), 0.075-0.2% (w/w), or around 0.1% (w/w), with a reasonable expectation of success.
As such, claim 70 is prima facie obvious.
Claim 73 is drawn to claim 60, comprising:
(I):
a. 20-85% (w/w), 40-75% (w/w), 50-70% (w/w), 55-65% (w/w), around 61% (w/w) water;
b. 0.1-60% (w/w), 5-55% (w/w), 10-50% (w/w), 30-50% (w/w), 35-45 % (w/w), or around 30 % (w/w) propylene glycol;
c. 0.1-15% (w/w), 0.5-12% (w/w), 1.0-10% (w/w), 1.5-7.5% (w/w), 2.0-6.0 % (w/w), 2.5-4.0 % (w/w), or around 5 % (w/w) pentylene glycol;
d. 0.1-10% (w/w), 0.2-5% (w/w), 0.4-2.0% (w/w), 0.6-1.0% (w/w), or around 0.8% (w/w) gelator(s);
e. 0.1-5% (w/w), 0.15-2% (w/w), 0.2-1% (w/w), 0.25-0.75% (w/w), or around 0.5% (w/w) CBD;
f. 0.1-5% (w/w), 0.15-3.0 % (w/w), 0.2-1.5% (w/w), 0.3-0.8 % (w/w), or around 0.5 % (w/w) panthenol;
g. 0.1-5% (w/w), 0.2-2% (w/w), 0.3-1% (w/w), 0.4-0.75% (w/w), or around 0.5% (w/w) hyaluronic acid, hyaluronate, or hyaluronic acid and hyaluronate;
h. 0.01-2.5% (w/w), 0.025-0.1.0% (w/w), 0.05-0.5% (w/w), 0.075-0.2% (w/w), or around 0.1% (w/w) benzalkonium chloride;
i. 0.01-5% (w/w), 0.05-2% (w/w), 0.1-1% (w/w), 0.2-0.5% (w/w), or around 0.3 % (w/w) allantoin; and
j. 0.01-2.5% (w/w), 0.025-0.1.0% (w/w), 0.05-0.5% (w/w), 0.075-0.2% (w/w), or around 0.1% (w/w) phytic acid, phytate, or phytic acid and phytate;
or (II):
a. 55-65% (w/w), around 61% (w/w) water;
b. 35-45 % (w/w), or around 30% (w/w) propylene glycol;
c. 2.5-4.0 % (w/w), or around 5 % (w/w) pentylene glycol;
d. 0.6-1.00% (w/w), or around 0.8% (w/w) gelator(s);
e. 0.25-0.75% (w/w), or around 0.5% (w/w) CBD;
f. 0.3-0.8 % (w/w), or around 0.65 % (w/w) panthenol;
g. 0.4-0.75% (w/w), or around 0.5% (w/w) hyaluronic acid, hyaluronate, or hyaluronic acid and hyaluronate;
h. 0.075-0.2% (w/w), or around 0.1% (w/w) benzalkonium chloride;
i. 0.2-0.5% (w/w), or around 0.3 % (w/w) allantoin; and
j. 0.075-0.2% (w/w), or around 0.1 (w/w) phytic acid, phytate, or phytic acid and phytate.
65. Stinchcomb et al. additionally teach the penetration enhancer pentylene glycol (i.e. pentane diol) in paragraph [0063], and teach that the penetration enhancer is present in an amount of “about 0.1%, about 0.2%, about 0.3%, about 0.4%, about 0.5%, about 0.6%, about 0.7%, about 0.8%, about 0.9%, about 1.0%, about 1.1%, about 1.2%, about 1.3%, about 1.4%, about 1.5%, about 1.6%, about 1.7%, about 1.8%, about 1.9%, about 2.0%, about 2.1%, about 2.2%, about 2.3%, about 2.4%, about 2.5%, about 2.6%, about 2.7%, about 2.8%, about 2.9%, about 3.0%, about 3.1%, about 3.2%, about 3.3%, about 3.4%, about 3.5%, about 3.6%, about 3.7%, about 3.8%, about 3.9%, about 4.0%, about 4.1%, about 4.2%, about 4.3%, about 4.4%, about 4.5%, about 4.6%, about 4.7%, about 4.8%, about 4.9%, about 5.0%,” which meets the limitation of component (c) of each of composition (I) and (II) of claim 79 (see paragraph [0068]).
66. Regarding component (j) of composition (I) and composition (II) of claim 79, Henriksen et al. additionally suggest the inclusion of phytic acid: “Phytic acid can liberate phosphate ions and is thus able to provide pH stability due to creation of a phosphate buffering effect in the gel. For example, phytic acid (CAS. No: 83-86-3) may be added. Phytic acid can liberate phosphate ions and is thus able to provide pH stability due to creation of a phosphate buffering effect in the gel.” (page 13, first two paragraphs). Henriksen et al. teach an amount of pH regulators of 1-3% (page 12, last paragraph).
67. Thus it would have been obvious to one skilled in the art before the effective filing date in view of the combined prior art of record to prepare an improved CBD composition for topical application comprising:
(a) around 55% or 68% water (taught by Henriksen et al),
(b) 45% propylene glycol, (taught by Lurya et al),
(c) 0.1-5% pentylene glycol (taught by Stinchcomb et al.
(d) 1% acrylates copolymer 1
(e) around 1% or 2% CBD (taught by Henriksen et al),
(f) 2.75% panthenol (taught by Henriksen et al)
(g) sodium hyaluronate in an amount of 0.5% w/w, (taught by Lurya et al)
(h) benzalkonium chloride in an amount of 0.01-2.5% (w/w), 0.025-0.1.0% (w/w), 0.05-0.5% (w/w), 0.075-0.2% (w/w), or around 0.1% (w/w), (taught by Stinchcomb et al)
(i) allantoin in an amount of 0.15% w/w, (taught by Lurya et al)
(j) and about 1% phytic acid (taught by Stinchcomb et al),
with a reasonable expectation of success. And, the rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law, please see In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988); In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992). See also In re Kotzab, 217 F.3d 1365, 1370, 55 USPQ2d 1313, 1317 (Fed. Cir. 2000) (setting forth test for implicit teachings); In re Eli Lilly & Co., 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) (discussion of reliance on legal precedent); In re Nilssen, 851 F.2d 1401, 1403, 7 USPQ2d 1500, 1502 (Fed. Cir. 1988) (references do not have to explicitly suggest combining teachings). Furthermore, MPEP 2144 teaches that the strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination.
Please refer to MPEP 2144.06 “I. COMBINING EQUIVALENTS KNOWN FOR THE SAME PURPOSE” wherein Kerkhoven is specifically referenced:
“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.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious).
As stated by the Court in KSR International Co., v. Teleflex Inc., 127 US 1727 (2007), “when a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious” (quoting Sakraida v. AG Pro, Inc., 425 US 273 (1976); see also: Merck v. Biocraft (874 F.2d 804, 807 (Fed. Cir. 1989), indicating that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands; Sundance, Inc. v. DeMonte Fabricated, Ltd., 550 F.3d 1356 (Fed. Cir. 2008): a claimed invention is obvious is it is a combination of known prior art elements that would reasonably have been expected to maintain their respective properties or functions after they had been combined.
68. As such, claim 73 is prima facie obvious.
Double Patenting
69. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
70. Claims 58-73, and 79 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 22-38 of copending Application No. 17/633,006(reference application), in view of
Lurya et al. and Stinchcomb et al.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Applicant’s instant claims are described in detail, above.
71. U.S. Application No. 17/633,006 recites the following hydroalcoholic gel composition:
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72. As such, the claims of Application No. 17/633,006 recite a hydroalcoholic gel CBD composition for topical application comprising pure crystalline CBD in an amount of 0.1-10% w/w, a skin penetrator in an amount of 0.5-1.5% w/w, ethanol in an amount of 10% w/w, and water to total 100% w/w, that does not comprise oil and is not an oil-in-water emulsion or a water-in-oil emulsion, comprises less than 0.1% of an additional cannabinoid component, and comprises additional components: 1-5% skin moisturizer including panthenol (claims 28 and 33-37), 0.4-2% of a thickener including arylate crosspolymer (claim 31), 0.05-0.3% pH stabilizer including phytic acid (claims 32 and 38).
73. The claims of Application No. 17/633,006 do not teach the inclusion of allantoin or hyaluronic acid.
74. Yet, Lurya et al. teach a topical gel composition for pain relief comprising (a) CBD, (b) Water, (c) a penetrating enhancer, (ii) allantoin in an amount of 0.15% w/w, and (iii) sodium hyaluronate in an amount of 0.5% w/w (sodium hyaluronate is the salt form of hyaluronic acid).
75. Thus it would have been obvious for one skilled in the art to combine the topical gel CBD formulation recited by Application No. 17/633,006 with components from the topical gel CBD formulation taught by Lurya et al., incorporating the skin moisturizer allantoin and the wound healing compound sodium hyaluronate, with a reasonable expectation of success.
76. The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law, please see In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988); In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992). See also In re Kotzab, 217 F.3d 1365, 1370, 55 USPQ2d 1313, 1317 (Fed. Cir. 2000) (setting forth test for implicit teachings); In re Eli Lilly & Co., 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) (discussion of reliance on legal precedent); In re Nilssen, 851 F.2d 1401, 1403, 7 USPQ2d 1500, 1502 (Fed. Cir. 1988) (references do not have to explicitly suggest combining teachings). Furthermore, MPEP 2144 teaches that the strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination. Please refer to MPEP 2144.06 “I. COMBINING EQUIVALENTS KNOWN FOR THE SAME PURPOSE” wherein Kerkhoven is specifically referenced:
“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.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious).
As stated by the Court in KSR International Co., v. Teleflex Inc., 127 US 1727 (2007), “when a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious” (quoting Sakraida v. AG Pro, Inc., 425 US 273 (1976).
77. The claims of Application No. 17/633,006 do not recite an antimicrobial.
78. Yet, Stinchcomb et al. teach a topical gel composition for pain relief comprising (a) CBD, (b) Water, ethanol, propylene glycol in a topical CBD formulation for pain relief, and suggest the inclusion of an antimicrobial:
“In one embodiment, the compositions described herein comprise an antimicrobial preservative. Illustrative anti-microbial preservatives include acids, including but not limited to benzoic acid, phenolic acid, sorbic acids, alcohols, benzethonium chloride, bronopol, butylparaben, cetrimide, chlorhexidine, chlorobutanol, chlorocresol, cresol, ethylparaben, imidurea, methylparaben, phenol, phenoxyethanol, phenylethyl alcohol, phenylmercuric acetate, phenylmercuric borate, phenylmercuric nitrate, potassium sorbate, propylparaben, sodium propionate, or thimerosal. The anti-microbial preservative, if present, is present in an amount by weight of the composition of about 0.1% to about 5%, about 0.2% to about 3%, or about 0.3% to about 2%, for example about 0.2%, about 0.4%, about 0.6%, about 0.8%, about 1%, about 1.2%, about 1.4%, about 1.6%, about 1.8%, about 2%, about 2.2%, about 2.4%, about 2.6%, about 2.8%, about 3.0%, about 3.2%, about 3.4%, about 3.6%, about 3.8%, about 4%, about 4.2%, about 4.4%, about 4.6%, about 4.8%, or about 5%.” (see paragraph [0080]). And, Stinchcomb et al. name additional quaternary ammonium preservatives including benzalkonium chloride in paragraph [0075].
79. It would have been obvious for one skilled in the art to combine the topical gel CBD formulation recited by Application No. 17/633,006 with the topical gel CBD formulation taught by Lurya et al., incorporating the antimicrobial component benzalkonium chloride in an amount of 0.01-2.5% (w/w), 0.025-0.1.0% (w/w), 0.05-0.5% (w/w), 0.075-0.2% (w/w), or around 0.1% (w/w), with a reasonable expectation of success.
80. And, in view of the claims of Application No. 17/633,006 and the disclosures of Lurya et al. and Stinchcomb et al. it would have been obvious to one skilled in the art to combine the components of each CBD composition in order to prepare an improved CBD composition for topical application, with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
81. Claims 58-73 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 43-46 and 50-55 of copending Application No. 18/564,550 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
82. Applicant’s instant claims are described in detail above.
83. U.S. Application 18/564,550 recites the following hydroalcoholic gel composition:
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84. As such, the claims of Application No. 18/564,550 recite a hydroalcoholic gel CBD composition for topical application comprising 98% pure crystalline CBD in an amount of 0.05-2.5% w/w, a skin penetrator that is a glycol in an amount of 12-70% w/w, and water to total 100% w/w, that does not comprise oil and is not an oil-in-water emulsion or a water-in-oil emulsion, comprises less than 0.1% of an additional cannabinoid component, and comprises additional components: 0.25-2% skin moisturizer that is panthenol, 0.5-5% of a gelling agent/gelator , 0.02-1% pH stabilizer that is phytic acid, allantoin in an amount of 0.15-1.5% w/w, and hyaluronic acid/salt in an amount of 0.2-2.5%.
85. The claims of Application No. 18/564,550 do not recite an antimicrobial.
86. Yet, Stinchcomb et al. teach a topical gel composition for pain relief comprising (a) CBD, (b) Water, and a glycol in a topical CBD formulation for pain relief, and suggest the inclusion of an antimicrobial:
“In one embodiment, the compositions described herein comprise an antimicrobial preservative. Illustrative anti-microbial preservatives include acids, including but not limited to benzoic acid, phenolic acid, sorbic acids, alcohols, benzethonium chloride, bronopol, butylparaben, cetrimide, chlorhexidine, chlorobutanol, chlorocresol, cresol, ethylparaben, imidurea, methylparaben, phenol, phenoxyethanol, phenylethyl alcohol, phenylmercuric acetate, phenylmercuric borate, phenylmercuric nitrate, potassium sorbate, propylparaben, sodium propionate, or thimerosal. The anti-microbial preservative, if present, is present in an amount by weight of the composition of about 0.1% to about 5%, about 0.2% to about 3%, or about 0.3% to about 2%, for example about 0.2%, about 0.4%, about 0.6%, about 0.8%, about 1%, about 1.2%, about 1.4%, about 1.6%, about 1.8%, about 2%, about 2.2%, about 2.4%, about 2.6%, about 2.8%, about 3.0%, about 3.2%, about 3.4%, about 3.6%, about 3.8%, about 4%, about 4.2%, about 4.4%, about 4.6%, about 4.8%, or about 5%.” (see paragraph [0080]). And, Stinchcomb et al. name additional quaternary ammonium preservatives including benzalkonium chloride in paragraph [0075].
87. Thus it would have been obvious for one skilled in the art to combine the topical gel CBD formulation recited by Application No. 18/564,550 with the antimicrobial component benzalkonium chloride in an amount of 0.01-2.5% (w/w), 0.025-0.1.0% (w/w), 0.05-0.5% (w/w), 0.075-0.2% (w/w), or around 0.1% (w/w), with a reasonable expectation of success.
88. And, the rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law, please see In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988); In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992). See also In re Kotzab, 217 F.3d 1365, 1370, 55 USPQ2d 1313, 1317 (Fed. Cir. 2000) (setting forth test for implicit teachings); In re Eli Lilly & Co., 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) (discussion of reliance on legal precedent); In re Nilssen, 851 F.2d 1401, 1403, 7 USPQ2d 1500, 1502 (Fed. Cir. 1988) (references do not have to explicitly suggest combining teachings). Furthermore, MPEP 2144 teaches that the strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination. Please refer to MPEP 2144.06 “I. COMBINING EQUIVALENTS KNOWN FOR THE SAME PURPOSE” wherein Kerkhoven is specifically referenced:
“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.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious).
As stated by the Court in KSR International Co., v. Teleflex Inc., 127 US 1727 (2007), “when a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious” (quoting Sakraida v. AG Pro, Inc., 425 US 273 (1976).
89. Thus, in view of the claims of Application No. 18/564,550 and the disclosure of Stinchcomb et al. it would have been obvious to one skilled in the art to combine the components of each CBD composition in order to prepare an improved CBD composition for topical application, with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
90. Claims 58-79 are pending in the application. Claims 72-78 are currently withdrawn from consideration. Claims 58-73 and 79 are rejected. No claim is presently allowed.
91. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANET L COPPINS whose telephone number is (571)272-0680. The examiner can normally be reached Monday-Friday 8:30AM-5PM EST.
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/JANET L COPPINS/Examiner, Art Unit 1628
/AMY L CLARK/Supervisory Patent Examiner, Art Unit 1628
Prosecution Insights