DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
Claims 1-21 are pending as of the response filed 06/11/2026. Applicant’s election of group I claims is maintained. Claims 1-9 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 10-21 are examined herein.
The objection to the specification and title of previous record is withdrawn in consideration of amendments to the specification.
In view of the pending claims, the 35 U.S.C. 101 rejection of record is maintained and updated to reflect claim amendments. Applicant’s arguments have been carefully considered and are addressed below.
The terminal disclaimer filed on 06/11/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of any patent granted on Application No 18/329,496 has been reviewed and is accepted. The terminal disclaimer has been recorded. The nonstatutory double patenting rejection of record is hereby withdrawn.
In view of the pending claims, new 35 U.S.C. 103 rejections are made, necessitated by the claim amendments. The new grounds of rejection addresses all the limitations of the amended claim. Applicant’s arguments are rendered moot since they are based on the rejection of previous record.
Claim Objections
Claim 18 is objected to because of the following informalities:
In claim 18, lines 1-2, it is suggested to amend the claim to read “… wherein the penetration enhancer further comprises hyaluronic acid” for improved clarity of claim language since claim 18 depends from claim 16, which already recites specific penetration enhancers.
Appropriate correction is required.
Claim Rejections - 35 USC § 101 – Maintained and updated
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.
Claims 10-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more.
The instant claims recite a composition for oral supplementation comprising: an ingestible pill comprising, or capsule containing, therapeutically effective amounts of: a plurality of cannabinoid compounds; a penetration enhancer; and a plurality of prebiotic polyphenols; and citicoline and 5-methyltetrahydrofolate (5-MTHF), wherein the citicoline, the 5-methyltetrahydrofolate, and the cannabinoid compounds are present in amounts that together enhance a cognitive effect of the cannabinoid compounds to a greater degree than the cannabinoid compounds alone; AND a composition for transdermal supplementation, comprising: an aqueous gel comprising therapeutically effective amounts of: a plurality of cannabinoid compounds; a penetration enhancer comprising eucalyptus oil and peppermint oil, wherein the eucalyptus oil and the peppermint oil are present in a combined amount that synergistically enhances penetration relative to either oil alone; a plurality of prebiotic polyphenols. The compositions comprise components, all of which are products of nature. For instance, cannabinoid compounds are products of nature. The instant specification, in Para. [0266], teaches penetrations enhancers comprise natural phytochemicals, such as eucalyptol, menthol, peppermint oil, all of which are derived from nature. The instant specification discloses embodiments in which the prebiotic polyphenols comprise resveratrol or other stilbenes, which are derived from plants, i.e., are a product of nature. The instant specification, in Para. [0040], teaches citicoline as a compound that is naturally produced in the body. The instant specification, in Para. [0039], teaches 5-MTHF as a naturally occurring form of folate. While the claims recite a pill, capsule or aqueous gel, the specification teaches the formulations may be homeopathic formulations (Para. [0265]) (homeopathic formulations frequently use natural excipients, which are generally non-toxic, biocompatible, and biodegradable, sourced from plants, minerals, or animals). Overall, the components of the recited compositions can be derived from natural sources. Moreover, the recitation of specific amounts of the prebiotic polyphenols (as in instant claim 15 and claim 21) does not affect this analysis because it does not markedly change the characteristics of the prebiotic polyphenols in the composition, and it continues to have the same properties in the composition as it did alone. Even though the Applicant claims synergistic enhancement of cognitive effect or synergistic enhancement of penetration, the ingredients are behaving exactly how they would naturally behave when placed together. Synergy is an expected result of combining these naturally occurring ingredients (as discussed in the rejections below). Thus, the claim is not meaningfully limited to amount to significantly more than the judicial exception.
The instant claims are directed to a natural product and nothing more. The claimed composition does not contain anything markedly different from its closest naturally occurring counterpart and thus is a product of nature judicial exception. This judicial exception is not integrated into a practical application because the claims are drawn to a composition, that at its broadest, only comprises one or more naturally occurring substances that are mixed together. Therefore, claims 10-21 are deemed patent ineligible subject matter.
The examiner reiterates, as noted before, that Applicant may amend the claims to include non-naturally occurring components, such as a penetration enhancer OR a composition drawn to an emulsion, that has 112(a) support in the specification to overcome this rejection. The examiner also previously noted that the claims directed to a method of treatment are devoid of a 35 U.S.C. 101 rejection, since it is integrated into a practical application.
Response to Arguments
Applicant argues on pages 6-7 of the response dated 06/11/2026 that “The Office Action did not identify a naturally occurring counterpart to the claimed compositions, nor did it analyze those compositions as a whole. Instead, the rejection identified individual components that may be derived from natural sources and concluded, from the character of those individual components, that the claimed compositions were products of nature. That approach does not establish that the claimed compositions, considered as complete manufactured dosage compositions, are not markedly different from any naturally occurring counterpart”. Applicant argues “Amended claim 16 recites an aqueous gel comprising, among other things, a penetration enhancer comprising eucalyptus oil and peppermint oil, wherein the eucalyptus oil and peppermint oil are present in a combined amount that synergistically enhances penetration relative to either oil alone. As described at [0266], the combination of eucalyptol and menthol provides penetration enhancement greater than the sum of the penetration enhancements provided by the two oils individually, and may improve transdermal penetration by a factor of 10 to 20 times”. Applicant argues “Amended claim 10 likewise recites an oral supplementation composition further comprising citicoline and 5-methyltetrahydrofolate, wherein the citicoline, 5-methyltetrahydrofolate, and cannabinoid compounds are present in amounts that together enhance a cognitive effect of the cannabinoid compounds to a greater degree than the cannabinoid compounds alone. As described at Para [0041], and further supported by Paras.[0039]-[0040], the combination of citicoline with 5-methyltetrahydrofolate provides synergistic effects on cognitive function and mood regulation, and combining citicoline with cannabinoids may enhance cognitive benefits of cannabinoids, including memory and attention span. This enhanced cognitive effect is a functional characteristic of the claimed combination as a whole, not a property of the cannabinoid compounds alone”.
Applicant's arguments have been fully considered but they are not persuasive.
As discussed in the rejection above, while the claims recite a pill, capsule or aqueous gel, the specification teaches the formulations may be homeopathic formulations with natural excipients. Simply mixing together naturally derived components does not change their fundamental character. The examiner recognizes that the courts have emphasized that to show a marked difference, a characteristic must be changed as compared to nature, and cannot be an inherent or innate characteristic of the naturally occurring counterpart or an incidental change in a characteristic of the naturally occurring counterpart. There is no indication that the natural products have been altered by any way that caused active components of the natural products to have any characteristics that are different from the naturally occurring components. So, the composition as a whole is drawn to a natural product without significantly more.
Although Applicant has amended claim 10 and claim 16 to recite synergistic enhancement of cognitive effect or penetration respectively, Applicant has not established “markedly different characteristics” of the synergistic combination. The examiner notes that mixing the natural ingredients does not structurally change the individual components themselves. The individual components simply perform their inherent, natural function and synergy is a natural physical consequence of the two components interacting. Even if the synergistic interaction were considered a functional characteristic of the claimed combination, there is no indication of any amounts for the claimed synergistic combination. Without showing the specific amounts (such as concentrations, amounts, or synergy factors), there is no way to evaluate if the effect is a true technical synergy or just a minor fluctuation caused by random experimental variation.
Applicant has not established that the claimed compositions are markedly different from their closest naturally occurring counterparts. Therefore, the 35 U.S.C. 101 rejection is maintained.
Claim Rejections - 35 USC § 103 - New
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over the combined teachings of Griffin (US 2023/0050379 A1, 16 February 2023, of previous record), Alves-Santos et al. (Prebiotic effect of dietary polyphenols: A systematic review, 21 September 2020, hereinafter Alves-Santos, of previous record), Marshall (US 2020/0397717 A1, 24 December 2020) and Perez et al. (A unique combination of micronutrients rejuvenates cognitive performance in aged mice, 2017, hereinafter Perez).
Note: The examiner notes that citicoline and citicholine have been used interchangeably in the claims and specification and are considered to represent the same compound.
Regarding instant claims 10-14, Griffin teaches a cannabis-containing composition comprising at least one cannabinoid, provided in a gel formulation, the at least one cannabinoid includes Δ9-tetrahydrocannabinol (THC) and cannabidiol (CBD) (i.e., a plurality of cannabinoid compounds and satisfies the limitation of instant claim 11) (Para. [0006]; Para. [0021]; Para. [0038]; Claim 1), and wherein the composition is formulated in unit dosage forms suitable for oral administration, among other routes (Para. [0006]; Para. [0021]; Claim 1). Griffin teaches the oral dosage forms include a tablet or capsule (Para. [0022]). Griffin teaches the compositions further comprise flavonoids (flavonoids are a large family of polyphenolic plant compounds) and additional active ingredients, such as hyaluronic acid, Boswellia serrata extract and resveratrol (a stilbene polyphenol) (Para. [0007]; Claim 14) (i.e., a plurality of polyphenols and satisfies the limitations of instant claims 12-14).
According to MPEP 2141.02(V), "In determining whether the invention as a whole would have been obvious under 35 U.S.C. 103, we must first delineate the invention as a whole. In delineating the invention as a whole, we look not only to the subject matter which is literally recited in the claim in question... but also to those properties of the subject matter which are inherent in the subject matter and are disclosed in the specification. . . Just as we look to a chemical and its properties when we examine the obviousness of a composition of matter claim, it is this invention as a whole, and not some part of it, which must be obvious under 35 U.S.C. 103." In re Papesch, 315 F.2d 381, 391, 137 USPQ 43, 51 (CCPA 1963) ("From the standpoint of patent law, a compound and all its properties are inseparable.").
In the instant case, hyaluronic acid, by virtue of its inherent property, is capable of functioning as a penetration enhancer. Resveratrol, by virtue of its inherent property, is a prebiotic polyphenol. Griffin teaches the compositions can be administered in any amount, including but not limited to a physiologically effective or acceptable dosage, i.e., a therapeutically effective dosage useful for nutritional purposes (i.e., for supplementation) (Para. [0031]).
Griffin does not explicitly teach wherein the plurality of polyphenols are prebiotic polyphenols; wherein the composition comprises citicoline and 5-methyltetrahydrofolate, wherein the citicoline, the 5-methyltetrahydrofolate, and the cannabinoid compounds are present in amounts that together enhance a cognitive effect of the cannabinoid compounds to a greater degree than the cannabinoid compounds alone.
Alves-Santos teaches that dietary polyphenols act as prebiotics based on preclinical studies, by stimulating the growth of beneficial gut microorganisms recognized as prebiotic targets (Lactobacillus spp., Bifidobacterium spp., Akkermansia spp., Roseburia spp., and Faecalibacterium spp.), and increase the production of short-chain fatty acids (SCFA), including butyrate (Abstract; Pg. 8, first column, last paragraph). Alves-Santos teaches the prebiotic effect of the flavanols (epigallocatechin gallate, epigallocatechin, epicatechin gallate, epicatechin), a flavonoid subclass (Pg. 3, first column, last paragraph – second column, continued paragraph).
Marshall teaches novel neuroprotective preparations of hemp oil and a proprietary blend of synergistic nutrients delivered in a highly-efficacious, lipophilic, oral (and topical) delivery system for cognitive enhancement (Title; Abstract; Para. [0008]). Marshall teaches a proprietary neurosupportive blend that comprises methyl-folate (methyl folate is a common name for 5-MTHF). Marshall teaches exemplary compositions that comprise cannabidiol and methyl-folate (i.e., MTHF) (Claim 10; Claim 11; Claim 12; Claim 13; Claim 14; Claim 15). Marshall teaches the synergistic effects of a broad-spectrum cannabinoid (hemp) extract (i.e. hemp oil) and magnesium are effectively coupled to a proprietary blend of synergistic, antioxidant, anti-inflammatory nutrients to create an optimal therapeutic effect with no undesirable, adverse effects (i.e. side-effects) (Para. [0028]).
Perez teaches a unique combination of micronutrients rejuvenates cognitive performance in aged mice (Title). Perez teaches a micronutrient diet composition supplemented with citicholine and 5-methyltetrahydrofolic acid improved cognitive performance in mice (Abstract). Perez teaches that manipulating specific micronutrients in the diet can slow the progression of cognitive decline (Pg. 98, first column, first full paragraph). Perez teaches the active form of vitamin B9, 5-methyltetrahydrofolate, as a preferred choice for supplementation because of its more direct effect on cells (Pg. 98, first column, third full paragraph). Perez teaches citicoline serves as a choline donor in the biosynthesis of acetyl choline neurotransmitter and neuronal membrane phospholipids such as phosphatidylcholine (Pg. 98, first column, third full paragraph). Perez teaches citicoline is included in the micronutrient diet composition owing to its potential for synergistic effects when combined with others (Pg. 98, first column, last paragraph).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, in view of the teachings of Griffin, Alves-Santos, Perez and Marshall, to have formulated a composition for oral supplementation comprising the components as instantly claimed, with a reasonable expectation of success in achieving an enhanced cognitive benefit. Griffin teaches a cannabis-containing gel formulation for oral administration comprising at least one cannabinoid, the at least one cannabinoid includes Δ9-tetrahydrocannabinol (THC) and cannabidiol (CBD). Griffin teaches the compositions further comprises flavonoids and additional active ingredients, such as hyaluronic acid, Boswellia serrata extract and resveratrol. Hyaluronic acid, by virtue of its inherent property, is capable of functioning as a penetration enhancer. Resveratrol, by virtue of its inherent property, is a prebiotic polyphenol. Griffin teaches oral dosage forms, such as a tablet or capsule. Griffin teaches the compositions are useful for nutritional purposes. Alves-Santos teaches that dietary polyphenols act as prebiotics by stimulating the growth of beneficial gut microorganisms. Marshall teaches neuroprotective preparations of hemp oil and a proprietary blend of synergistic nutrients delivered in a highly-efficacious, lipophilic, oral delivery system for cognitive enhancement. Marshall teaches exemplary compositions that comprise cannabidiol and methyl-folate (i.e., MTHF). Marshall teaches the synergistic effects of a broad-spectrum cannabinoid (hemp) extract (i.e. hemp oil) and magnesium are effectively coupled to a proprietary blend of synergistic, antioxidant, anti-inflammatory nutrients to create an optimal therapeutic effect with no undesirable, adverse effects (i.e. side-effects). Perez teaches a unique combination of micronutrients rejuvenates cognitive performance in aged mice. Perez teaches a micronutrient diet composition supplemented with citicholine and 5-methyltetrahydrofolic acid improved cognitive performance in mice. Perez teaches the active form of vitamin B9, 5-methyltetrahydrofolate, as a preferred choice for supplementation because of its more direct effect on cells. Perez teaches citicoline is included in the micronutrient diet composition owing to its potential for synergistic effects when combined with others.
According to MPEP § 2144.05(II)(A), "It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."
Therefore, one of ordinary skill in the art would have been motivated to make the claimed combination since all the claimed elements are taught in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP § 2143 (I)(A). The motivation being to provide a tailored synergistic blend of ingredients for optimal therapeutic effect with no undesirable, adverse effects (i.e. side-effects) (Marshall, Para. [0028]), thereby slow the progression of cognitive decline (Perez, Pg. 98, first column, first full paragraph). Absent any evidence to the contrary, a PHOSITA would have had a reasonable expectation of success that the components would potentiate each other to slow cognitive decline.
Therefore, the limitations of instant claims 10-14 are rendered prima facie obvious.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over the combined teachings of Griffin (US 2023/0050379 A1, 16 February 2023, of previous record), Alves-Santos et al. (Prebiotic effect of dietary polyphenols: A systematic review, 21 September 2020, hereinafter Alves-Santos, of previous record), Marshall (US 2020/0397717 A1, 24 December 2020) and Perez et al. (A unique combination of micronutrients rejuvenates cognitive performance in aged mice, 2017, hereinafter Perez) as applied to claims 10-14 above, and further in view of Lephart (US 2021/0145764 A1, 20 May 2021, of previous record).
The teachings of Griffin, Alves-Santos, Marshall and Perez are set forth in the obviousness rejection above and incorporated herein by reference.
Regarding instant claim 15, the combined teachings of Griffin, Alves-Santos, Marshall and Perez render the composition for oral supplementation as in instant claim 10, prima facie obvious. Griffin, Alves-Santos, Marshall and Perez do not teach wherein the therapeutically-effective amount of prebiotic polyphenols is between 100-500 mg.
Lephart teaches a composition for use as a supplement comprising: cannabidiol, one or more polyphenolic compounds, and one or more other active ingredients selected from the group that includes hyaluronic acid (Abstract; Paras. [0011]-[0012]; Claim 1, Claim 2). Lephart teaches the compositions may be formulated in a form for a gel for transdermal application or a tablet, capsule for oral administration (Para. [0012]). Lephart teaches the polyphenol selected from equol, resveratrol, present in about 0.1 % to 10 % of the composition for topical uses and wherein the racemic or non-racemic equol forms are present from about 1 mg to 15 mg, resveratrol from about 100-500 mg for oral uses (Para. [0012]; Claim 7). Lephart teaches more than one polyphenolic compound may be included to enhance the actions of resveratrol and other polyphenolic compounds and the composition exerts a synergistic benefit (Para. [0049]; Para. [0101]; Para. [0111]).
According to MPEP 2144.05(II)(A), "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Therefore, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed amounts of the prebiotic polyphenol compounds for oral administration, in the absence of any criticality of the recited amounts. The motivation being to provide an exemplary oral composition comprising cannabinoids and polyphenols that exerts additional synergistic benefit of defending against oxidative stress and enhancement of antioxidant protection (Lephart, Para. [0049]; Para. [0101]).
Claims 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over the combined teachings of Griffin (US 2023/0050379 A1, 16 February 2023, of previous record), Guynn (US 2022/0378718 A1, 01 December 2022, of previous record), Alves-Santos et al. (Prebiotic effect of dietary polyphenols: A systematic review, 21 September 2020, hereinafter Alves-Santos, of previous record) and Caliskan et al. (Essential Oils as Skin Permeation Boosters and Their Predicted Effect Mechanisms, 2020, hereinafter Caliskan).
Regarding instant claims 16-20, Griffin teaches a cannabis-containing composition comprising at least one cannabinoid, provided in a gel formulation, the at least one cannabinoid includes Δ9-tetrahydrocannabinol (THC) and cannabidiol (CBD) (i.e., a plurality of cannabinoid compounds and satisfies the limitation of instant claim 17) (Para. [0006]; Para. [0021]; Para. [0038]; Claim 1), and wherein the composition is formulated in unit dosage forms suitable for transdermal administration, among other routes (Para. [0006]; Para. [0021]). Griffin teaches the compositions further comprises flavonoids (flavonoids are a large family of polyphenolic plant compounds) and additional active ingredients, such as hyaluronic acid, Boswellia serrata extract and resveratrol (a stilbene polyphenol) (Para. [0007]; Claim 14) (i.e., a plurality of polyphenols and satisfies the limitations of instant claims 18-20).
According to MPEP 2141.02(V), "In determining whether the invention as a whole would have been obvious under 35 U.S.C. 103, we must first delineate the invention as a whole. In delineating the invention as a whole, we look not only to the subject matter which is literally recited in the claim in question... but also to those properties of the subject matter which are inherent in the subject matter and are disclosed in the specification. . . Just as we look to a chemical and its properties when we examine the obviousness of a composition of matter claim, it is this invention as a whole, and not some part of it, which must be obvious under 35 U.S.C. 103." In re Papesch, 315 F.2d 381, 391, 137 USPQ 43, 51 (CCPA 1963) ("From the standpoint of patent law, a compound and all its properties are inseparable.").
In the instant case, hyaluronic acid, by virtue of its inherent property, is capable of functioning as a penetration enhancer. Resveratrol, by virtue of its inherent property, is a prebiotic polyphenol. Griffin teaches the compositions can be administered in any amount, including but not limited to a physiologically effective or acceptable dosage, i.e., a therapeutically effective dosage useful for nutritional purposes (i.e., for supplementation) (Para. [0031]).
Griffin does not explicitly teach wherein the composition for transdermal supplementation is an aqueous gel and wherein the plurality of polyphenols are prebiotic polyphenols; a penetration enhancer comprising eucalyptus oil and peppermint oil, wherein the eucalyptus oil and the peppermint oil are present in a combined amount that synergistically enhances penetration relative to either oil alone.
Guynn teaches transdermal compositions comprising cannabinoids (Para. [0002]). Guynn teaches the cannabinoid component can be water soluble or water dispersible (Para. [0038]). Guynn teaches an aqueous solution or gel of the cannabinoid (in 70% aqueous DMSO) to reduce or minimize skin irritation (Para. [0033]; Para. [0138]). Guynn teaches the composition comprises a terpenoid component selected from a group that includes eucalyptol (Para. [0039]; Para. [0071]; Claim 2).
Alves-Santos teaches that dietary polyphenols act as prebiotics based on preclinical studies, by stimulating the growth of beneficial gut microorganisms recognized as prebiotic targets (Lactobacillus spp., Bifidobacterium spp., Akkermansia spp., Roseburia spp., and Faecalibacterium spp.), and increase the production of short-chain fatty acids (SCFA), including butyrate (Abstract; Pg. 8, first column, last paragraph). Alves-Santos teaches the prebiotic effect of the flavanols (epigallocatechin gallate, epigallocatechin, epicatechin gallate, epicatechin), a flavonoid subclass (Pg. 3, first column, last paragraph – second column, continued paragraph).
Caliskan teaches essential oils as skin permeation boosters/enhancers to increase the permeability of medication through the skin (Abstract). Caliskan teaches that essential oils are successful in increasing skin penetration of both lipophilic and hydrophilic drugs (Abstract) with eucalyptus oil and peppermint oil being exemplified (Table 1). Caliskan teaches essential oils, especially, eucalyptus, peppermint and turpentine oils increased skin penetration of a drug without any permanent change in the structure of skin barriers (Pg. 28, second column, first full paragraph). Caliskan teaches synergistic effects will be observed in formulations chosen according to the biological activities (Pg. 28, first column, last paragraph). Caliskan teaches essential oils are preferred as penetration enhancers because they are natural, do not damage the skin while increasing skin penetration, less toxic, and less allergenic (Abstract; Pg. 28, second column, last paragraph; Pg. 29, first column, last paragraph).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, in view of the teachings of Griffin, Guynn, Alves-Santos and Caliskan, to have formulated a composition for transdermal supplementation comprising the components as instantly claimed, with a reasonable expectation of success in achieving an enhanced skin penetration. Griffin teaches a cannabis-containing composition comprising at least one cannabinoid, provided in a gel formulation, the at least one cannabinoid includes Δ9-tetrahydrocannabinol (THC) and cannabidiol (CBD), wherein the composition is formulated for transdermal administration. Griffin teaches the compositions further comprises flavonoids and additional active ingredients, such as hyaluronic acid, Boswellia serrata extract and resveratrol. Hyaluronic acid, by virtue of its inherent property, is capable of functioning as a penetration enhancer. Resveratrol, by virtue of its inherent property, is a prebiotic polyphenol. Griffin teaches the compositions are useful for nutritional purposes. Guynn teaches transdermal compositions comprising cannabinoids. Guynn teaches an aqueous solution or gel of the cannabinoid (in 70% aqueous DMSO) to reduce or minimize skin irritation. Alves-Santos teaches that dietary polyphenols act as prebiotics by stimulating the growth of beneficial gut microorganisms. Caliskan teaches essential oils as skin permeation boosters/enhancers to increase the permeability of medication through the skin. Caliskan teaches essential oils, especially, eucalyptus, peppermint oils increased skin penetration of a drug without any permanent change in the structure of skin barriers. Caliskan teaches synergistic effects will be observed in formulations chosen according to the biological activities. Caliskan teaches essential oils are preferred as penetration enhancers because they are natural, do not damage the skin while increasing skin penetration, less toxic, and less allergenic.
According to MPEP § 2144.05(II)(A), "It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."
Therefore, one of ordinary skill in the art would have been motivated to make the claimed combination for transdermal supplementation since all the claimed elements are taught in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP § 2143 (I)(A). The motivation being for enhanced skin penetration of a drug without any permanent change in the structure of skin barriers (Caliskan, Pg. 28, second column, last paragraph; Pg. 29, first column, last paragraph). Absent evidence to the contrary, a PHOSITA would have had a reasonable expectation of success that the components would work synergistically to enhance skin permeation.
Therefore, the limitations of instant claims 16-20 are rendered prima facie obvious.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over the combined teachings of Griffin (US 2023/0050379 A1, 16 February 2023, of previous record), Guynn (US 2022/0378718 A1, 01 December 2022, of previous record), Alves-Santos et al. (Prebiotic effect of dietary polyphenols: A systematic review, 21 September 2020, hereinafter Alves-Santos, of previous record) and Caliskan et al. (Essential Oils as Skin Permeation Boosters and Their Predicted Effect Mechanisms, 2020, hereinafter Caliskan) as applied to claims 16-20 above, and further in view of Lephart (US 2021/0145764 A1, 20 May 2021, of previous record).
The teachings of Griffin, Guynn, Alves-Santos and Caliskan are set forth in the obviousness rejection above and incorporated herein by reference.
Regarding instant claim 21, the combined teachings of Griffin, Guynn, Alves-Santos and Caliskan render the composition for transdermal supplementation as in instant claim 16, prima facie obvious. Griffin, Guynn and Alves-Santos do not teach wherein the therapeutically-effective amount of prebiotic polyphenols is between 100-500 mg.
Lephart teaches a composition for use as a supplement comprising: cannabidiol, one or more polyphenolic compounds, and one or more other active ingredients selected from the group that includes hyaluronic acid (Abstract; Paras. [0011]-[0012]; Claim 1, Claim 2). Lephart teaches the compositions may be formulated in a form for a gel for transdermal application or a tablet, capsule for oral administration (Para. [0012]). Lephart teaches the polyphenol selected from equol, resveratrol, present in about 0.1 % to 10 % of the composition for topical uses and wherein the racemic or non-racemic equol forms are present from about 1 mg to 15 mg, resveratrol from about 100-500 mg for oral uses (Para. [0012]; Claim 7). Lephart teaches more than one polyphenolic compound may be included to enhance the actions of resveratrol and other polyphenolic compounds and the composition exerts a synergistic benefit (Para. [0049]; Para. [0101]; Para. [0111]).
According to MPEP 2144.05(II)(A), "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Therefore, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed amounts of the prebiotic polyphenol compounds for transdermal administration, in the absence of any criticality of the recited amounts. The motivation being to provide an exemplary transdermal composition comprising cannabinoids and polyphenols that exerts additional synergistic benefit of defending against oxidative stress and enhancement of antioxidant protection (Lephart, Para. [0049]; Para. [0101]).
Conclusion
Claims 10-21 are rejected.
Claim 18 is objected to.
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PADMAJA S RAO whose telephone number is (571)272-9918. The examiner can normally be reached on 9:00-5:30pm EDT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney L Klinkel can be reached on (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PADMAJA S RAO/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
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