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 Claims and Response to Restriction Requirement
Claims 1-21 are pending as of the response filed 02/16/2026. Applicant’s election of group I claims 10-21 without traverse is acknowledged. Claims 1-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 10-21 are examined herein.
Priority
No priority benefit has been claimed. Accordingly, claims 10-21 have an effective filing date of 06/05/2023, the filing date of the instant application.
Specification
The disclosure is objected to because of the following informalities:
In page 2, the title “DETAILED DESCRIPTION OF THE DRAWING FIGURES” should be replaced by “DETAILED DESCRIPTION OF THE INVENTION“, since there are no drawings submitted with the invention.
Appropriate correction is required.
Title of Invention Is Not Descriptive
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. The following title is being suggested: “Composition and methods of treatment using synergistically enhanced supplementation of cannabinoids and prebiotic polyphenols”.
See MPEP 606.01, “Where the title is not descriptive of the invention claimed, the examiner should require the substitution of a new title that is clearly indicative of the invention to which the claims are directed.”
Claim Rejections - 35 USC § 101
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 a composition for transdermal supplementation, comprising: an aqueous gel comprising therapeutically effective amounts of: a plurality of cannabinoid compounds; a penetration enhancer; and 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. 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. The claim is not meaningfully limited to amount to significantly more than the judicial exception.
Thus, 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. Therefore, claims 10-21 are deemed patent ineligible subject matter.
The examiner notes 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. While maintaining the restriction requirement, the examiner notes 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.
Claim Rejections - 35 USC § 103
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) and Alves-Santos et al. (Prebiotic effect of dietary polyphenols: A systematic review, 21 September 2020, hereinafter Alves-Santos).
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.
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).
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 and Alves-Santos, to have arrived at the claimed composition for oral supplementation, with a reasonable expectation of success. 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 oral 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 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.
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).
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), Guynn (US 2022/0378718 A1, 01 December 2022) and Alves-Santos et al. (Prebiotic effect of dietary polyphenols: A systematic review, 21 September 2020, hereinafter Alves-Santos).
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.
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]).
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).
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 and Alves-Santos, to have arrived at the claimed composition for transdermal supplementation, with a reasonable expectation of success. 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.
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. The motivation being to provide an exemplary transdermal composition comprising cannabinoids and polyphenols that minimizes skin irritation, thereby enhancing patient compliance (Guynn, Para. [0033]). See MPEP § 2143 (I)(A) and MPEP § 2143 (I)(G).
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) and Alves-Santos et al. (Prebiotic effect of dietary polyphenols: A systematic review, 21 September 2020, hereinafter Alves-Santos) as applied to claims 10-14 above, and further in view of Lephart (US 2021/0145764 A1, 20 May 2021).
The teachings of Griffin and Alves-Santos are set forth in the obviousness rejection above and incorporated herein by reference.
Regarding instant claim 15, the combined teachings of Griffin and Alves-Santos render the composition for oral supplementation as in instant claim 10, prima facie obvious. Griffin 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 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 a synergistic benefit of defending against oxidative stress and enhancement of antioxidant protection (Lephart, Para. [0049]; Para. [0101]).
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), Guynn (US 2022/0378718 A1, 01 December 2022) and Alves-Santos et al. (Prebiotic effect of dietary polyphenols: A systematic review, 21 September 2020, hereinafter Alves-Santos) as applied to claims 16-20 above, and further in view of Lephart (US 2021/0145764 A1, 20 May 2021).
The teachings of Griffin, Guynn and Alves-Santos are set forth in the obviousness rejection above and incorporated herein by reference.
Regarding instant claim 21, the combined teachings of Griffin, Guynn and Alves-Santos 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 a synergistic benefit of defending against oxidative stress and enhancement of antioxidant protection (Lephart, Para. [0049]; Para. [0101]).
Double Patenting
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 10-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-13 and 18-20 of co-pending Application No 18/329,496 in view of Lephart (US 2021/0145764 A1, 20 May 2021) and Alves-Santos et al. (Prebiotic effect of dietary polyphenols: A systematic review, 21 September 2020, hereinafter Alves-Santos).
Although the claims at issue are not identical, both sets of claims are drawn to a composition for oral supplementation and a composition for transdermal supplementation.
The instant claims are drawn to a composition for oral supplementation as in instant claim 10 and a composition for transdermal supplementation as in instant claim 16.
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The claims of the reference ‘496 application are drawn to a composition for oral supplementation as in claim 11 of the reference application and a composition for transdermal supplementation as in instant claim 18 of the reference application.
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Claims 11-13 and 18-20 of the reference ‘496 application anticipates the components of the composition for oral supplementation and composition for transdermal supplementation with respect to the cannabinoid component and penetration enhancer component, wherein the cannabinoid comprises cannabidiol and the penetration enhancer comprises hyaluronic acid. Moreover, the use of the open-ended transitional phrase “comprises” allows for the inclusion of additional components not recited in the claim.
The claims of the reference ‘496 application does not teach a plurality of prebiotic polyphenols; wherein the plurality of prebiotic polyphenols comprise a stilbene; wherein the stilbene is resveratrol; wherein the therapeutically-effective amount of prebiotic polyphenols is between 100-500 mg.
Lephart teaches a composition comprising: one or more polyphenolic compounds, its isomer or analog and one or more other active ingredients selected from the group that includes hyaluronic acid (Abstract; Para. [0012]; Claim 2). Lephart teaches the composition may also or alternatively include cannabidiol (Abstract; Claim 1). 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 the compositions for use as a supplement (Para. [0012]). 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]).
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).
Therefore, using the same rationale as discussed in the 103 rejection above, one of ordinary skill in the art would have been motivated to make the claimed combination since all the claimed elements are taught by the combined teachings of the reference ‘496 application and the prior art.
The teachings of the reference ‘496 application in view of Lephart and Alves-Santos render obvious the limitations of instant claims 10-21.
Therefore, instant claims 10-21 and claims 11-13 and 18-20 of co-pending Application No 18/329,496 are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Citation of Pertinent Prior Art
The following prior art made of record but not relied upon is pertinent to Applicant's disclosure.
Crisler (US 2022/0347245 A1, 03 November 2022) teaches a composition comprising a plurality of cannabinoids, wherein the cannabinoid may be cannabidiol (2-(6-isopropenyl-3-methyl-5-cyclohexen-1-yl)-5-pentyl-1,3-benzenediol, CBD. Crisler teaches the composition further comprises an antioxidant and a penetration enhancer. Crisler teaches the antioxidants may be one or more polyphenols chosen from resveratrol, hypericin, ellagic acid, oleuropein, polyphenols, magnolol, honokiol, paeonol, or combinations thereof (i.e., a plurality of polyphenols). Crisler teaches the penetration enhancer may be hyaluronic acid (Crisler does not teach an ingestible pill/capsule or aqueous gel form of the instant claims).
Conclusion
Claims 10-21 are rejected.
No claims are allowed.
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/PADMAJA S RAO/Examiner, Art Unit 1627
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