DETAILED ACTION
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 13 is withdrawn.
Claims 1-3, 5-12, 14-15, and 18-23 are pending and represent all claims currently under consideration.
Response to Amendment
The amendment filed 04/27/2026 has been entered.
Claims 1, 8, and 11 were amended. Claims 4 and 16-17 were canceled. Claims 18-23 were newly added. No new material was added.
The terminal disclaimer filed on 04/27/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of Application No. 18/257,796 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Applicant’s amendments have overcome the previous rejections on the ground of nonstatutory double patenting and under 35 U.S.C. 112.
The previous rejections of claims 4 and 16-17 are moot, because the claims were canceled.
The rejections of claims 1-3, 5-12, and 14-15 under 35 U.S.C. 103 have been modified to address the amendments and maintained.
Claims 18-23 are newly rejected under 35 U.S.C. 103.
Response to Arguments
Applicant's arguments filed 04/27/2026 have been fully considered but they are not persuasive.
Applicant argues that there is no teaching in Bevier that a polysaccharide could contribute to vesicle deformability or be used to enhance skin penetration through modulation of vesicle mechanics, and that Pacchetti is also silent to the effect on vesicle deformability and transdermal delivery performance (Remarks, pages 7-8). This argument is not persuasive, because while Bevier and Pacchetti do not measure an enhanced penetration as compared to a composition comprising a cannabinoid in an oil-based vehicle, Bevier specifically teaches a vesicle such as a niosome serves as a penetration enhancer (Bevier, page 4, paragraph 0044). The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise. Therefore, absent evidence to the contrary, the composition of Bevier and Pacchetti would be expected to result in the claimed enhanced penetration. The deformability index of niosomes as claimed is considered to be a property of the claimed invention. A chemical composition and its properties are inseparable. See MPEP § 2112.01(II). Bevier and Pacchetti teach the claimed composition as stated in the rejection below. Therefore, the composition of Bevier and Pacchetti would be expected to result in the claimed deformability index.
Applicant argues that the increase in permeation observed in Examples 3-4 represents an unexpected technical effect (Remarks, page 8). This argument is not persuasive, because the evidence referenced by the Applicant compares a niosome composition to a non-niosome solution of cannabidiol (instant specification, pages 14-16). As stated above, Bevier specifically teaches a vesicle such as a niosome serves as a penetration enhancer (Bevier, page 4, paragraph 0044). Therefore, the increased in permeation resulting from niosomes is not unexpected.
Applicant argues that the combination of the main references with Synytsya and/or Blume appears to be based on hindsight, because Blume does not teach incorporating polysaccharides such as beta-glucans to influence the mechanical properties of vesicles, and Synytsya provides only general background on glucan structures (Remarks, pages 8-9). This argument is not persuasive, because Synytsya is referenced as evidentiary support that cellulose is known in the field to be a beta glucan. Bevier, Pacchetti, and Blume are all considered to be analogous to the claimed invention, because all are in the same field of topical compositions comprising niosomes comprising polymers. It has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Blume is in the same field of topical compositions comprising niosomes comprising polymers, as previously mentioned in the Office Action mailed 01/26/2026. Therefore, the rejection over Bevier, Pacchetti, and Blume is proper.
New Claim Rejections - 35 USC § 112
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.
Claims 1-3, 5-12, 14-15, and 18-23 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.
Regarding claims 1 and 11, the term “oil-based” is a relative term which renders the claim indefinite. The term “oil-based” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what amount of oil would need to be present to be considered an oil-based vehicle.
Regarding claims 2-3, 5-10, 14-15, and 18, each claim is dependent on the rejected claim 1 and does not cure its deficiencies, and therefore is deficient for the same reasons as above.
Regarding claims 12 and 19-23, each claim is dependent on the rejected claim 11 and does not cure its deficiencies, and therefore is deficient for the same reasons as above.
Modified/Maintained 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 1-3, 5-9, 11-12, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Bevier (US 20130011484 A1), further in view of Pacchetti (US 20170281481 A1; IDS reference, 08/31/2022), and evidenced by Synytsya (Annals of Translational Medicine, 2014). The references were previously cited by the Examiner.
Regarding claim 1, Bevier teaches a composition comprising niosomes encapsulating a cannabinoid receptor binding agent (claim 13), which can be cannabidiol (i.e., at least one cannabinoid; page 14, paragraph 0147, table 2), and is aqueous (page 14, paragraph 0147, table 2), and exemplifies such niosomes to be 150-300 nm in size (i.e., smaller than 500 nm; Bevier, page 11, paragraph 0119, formulation 9). Bevier teaches nanoparticles may be coated with a polymer or polysaccharide (Bevier, page 5, paragraph 0057), and teaches natural polymers which can be cellulose (i.e., a beta-glucan as evidenced by Synytsya, table 1; Bevier, page 8, paragraph 0086). Bevier teaches the composition is for topical use (Bevier, page 1, paragraph 0002) and further teaches the use of excipients (Bevier, page 5, paragraph 0060) which should be compatible with the intended functionality (i.e., the excipient should be topically acceptable; Bevier, page 6, paragraph 0060).
Bevier does not specifically teach a polyglycerol which is esterified with a fatty acid, but does teach the use of non-ionic surfactants as permeation enhancers (Bevier, page 7, paragraph 0073) and further teaches permeation enhancers can be encapsulated within the vesicle with the cannabinoid (Bevier, page 5, paragraph 0051). Pacchetti teaches a topical composition comprising niosomes having a size of smaller than 500 nm and comprising a topically acceptable excipient (Pacchetti, abstract), wherein the niosomes comprise esters of linear or branched polyglycerols with saturated or monounsaturated linear fatty acids (Pacchetti, page 2, paragraph 0026). Pacchetti defines the esterified linear or branched polyglycerols as non-ionic surfactants (Pacchetti, claim 6).
Bevier and Pacchetti do not measure an enhanced penetration as compared to a composition comprising a cannabinoid in an oil-based vehicle. However, Bevier teaches a vesicle such as a niosome serves as a penetration enhancer (Bevier, page 4, paragraph 0044). The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise. Therefore, absent evidence to the contrary, the composition of Bevier and Pacchetti would be expected to result in the claimed enhanced penetration.
Bevier and Pacchetti are considered to be analogous to the claimed invention, because both are in the same field of topical compositions comprising niosomes comprising polymers. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Bevier to have included esters of linear or branched polyglycerols with saturated or monounsaturated linear fatty acids (Pacchetti, page 2, paragraph 0026) as taught by Pacchetti, because Bevier teaches the use of non-ionic surfactants to enhance permeation (Bevier, page 7, paragraph 0073), while Pacchetti teaches esters of linear or branched polyglycerols as particularly preferred surfactants in niosome production (Pacchetti, page 2, paragraph 0039).
Regarding claim 2, Bevier and Pacchetti together teach all the elements of the current invention as applied to claim 1. Bevier further teaches the use of natural or synthetic cannabinoids (Bevier, page 2, paragraph 0029).
Regarding claim 3, Bevier and Pacchetti together teach all the elements of the current invention as applied to claim 1. Bevier further teaches the polysaccharide is a natural polymer (Bevier, page 8, paragraph 0086).
Regarding claim 5, Bevier and Pacchetti together teach all the elements of the current invention as applied to claim 1. As above, Bevier does not specifically teach a polyglycerol which is esterified with a fatty acid, but does teach the use of non-ionic surfactants as permeation enhancers (Bevier, page 7, paragraph 0073) and further teaches permeation enhancers can be encapsulated within the vesicle with the cannabinoid (Bevier, page 5, paragraph 0051). Pacchetti teaches niosomes comprising esters of linear or branched polyglycerols with saturated or monounsaturated linear fatty acids (Pacchetti, page 2, paragraph 0026), and further teaches the polyglycerol is preferably triglycerol, tetraglycerol, hexaglycerol, octaglycerol, or decaglycerol (Pacchetti, page 2, paragraph 0042). Pacchetti defines the esterified linear or branched polyglycerols as non-ionic surfactants (Pacchetti, claim 6). As above, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Bevier to have included a preferred polyglycerol ester (Pacchetti, page 2, paragraph 0026) as taught by Pacchetti, because Bevier teaches the use of non-ionic surfactants to enhance permeation (Bevier, page 7, paragraph 0073), while Pacchetti teaches esters of linear or branched polyglycerols as particularly preferred surfactants in niosome production (Pacchetti, page 2, paragraph 0039).
Regarding claim 6, Bevier and Pacchetti together teach all the elements of the current invention as applied to claim 1. As above, Bevier does not specifically teach a polyglycerol which is esterified with a fatty, but does teach the use of non-ionic surfactants as permeation enhancers (Bevier, page 7, paragraph 0073) and further teaches permeation enhancers can be encapsulated within the vesicle with the cannabinoid (Bevier, page 5, paragraph 0051). Pacchetti, however, teaches esters of linear or branched polyglycerols with saturated or monounsaturated linear fatty acids (Pacchetti, page 2, paragraph 0026), wherein the fatty acid comprises a monocarboxylic acid having from 4-32 carbon atoms, including stearic acid (Pacchetti, page 3, paragraph 0044). As above, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Bevier to have included a preferred polyglycerol/fatty acid ester (Pacchetti, page 2, paragraph 0026) as taught by Pacchetti, because Bevier teaches the use of non-ionic surfactants to enhance permeation (Bevier, page 7, paragraph 0073), while Pacchetti teaches that an ester of the two is particularly preferred for niosome production (Pacchetti, page 2, paragraph 0039).
Regarding claim 7, Bevier and Pacchetti together teach all the elements of the current invention as applied to claim 1. As above, Bevier does not specifically teach a polyglycerol which is esterified with a fatty, but does teach the use of non-ionic surfactants as permeation enhancers (Bevier, page 7, paragraph 0073) and further teaches permeation enhancers can be encapsulated within the vesicle with the cannabinoid (Bevier, page 5, paragraph 0051). Pacchetti, however, teaches esters of linear or branched polyglycerols with saturated or monounsaturated linear fatty acids (Pacchetti, page 2, paragraph 0026), wherein the fatty acid comprises a monocarboxylic acid having from 4-32 carbon atoms, including stearic acid (Pacchetti, page 3, paragraph 0044). As above, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Bevier to have included a preferred polyglycerol/fatty acid ester (Pacchetti, page 2, paragraph 0026) as taught by Pacchetti, because Bevier teaches the use of non-ionic surfactants to enhance permeation (Bevier, page 7, paragraph 0073), while Pacchetti teaches that an ester of the two is particularly preferred for niosome production (Pacchetti, page 2, paragraph 0039).
Regarding claim 8, Bevier and Pacchetti together teach all the elements of the current invention as applied to claim 1. As above, Bevier does not specifically teach a polyglycerol which is esterified with a fatty acid, but does teach the use of non-ionic surfactants as permeation enhancers (Bevier, page 7, paragraph 0073) and further teaches permeation enhancers can be encapsulated within the vesicle with the cannabinoid (Bevier, page 5, paragraph 0051). Pacchetti, however, teaches esters of linear or branched polyglycerols with saturated or monounsaturated linear fatty acids (Pacchetti, page 2, paragraph 0026), wherein the fatty acid comprises a monocarboxylic acid having from 4-32 carbon atoms, including myristoleic acid (Pacchetti, page 3, paragraph 0046). As above, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Bevier to have included a preferred polyglycerol/fatty acid ester (Pacchetti, page 2, paragraph 0026) as taught by Pacchetti, because Bevier teaches the use of non-ionic surfactants to enhance permeation (Bevier, page 7, paragraph 0073), while Pacchetti teaches that an ester of the two is particularly preferred for niosome production (Pacchetti, page 2, paragraph 0039).
Regarding claim 9, Bevier and Pacchetti together teach all the elements of the current invention as applied to claim 1. Bevier teaches the use of glycols (Bevier, page 3, paragraph 0037) such as propylene glycol (Bevier, page 8, paragraph 0085), but does not specify a glycol having from 4-16 carbon atoms. Pacchetti, however, teaches glycols to include both propylene glycol and butylene glycol (i.e., a glycol with 4 carbon atoms; Pacchetti, page 4, paragraph 0077). It would have been prima facie obvious to one of ordinary skill in the art to utilize butylene glycol in place of the propylene glycol taught by Bevier, because Pacchetti teaches the two chemicals to be reasonable alternatives (Pacchetti, page 4, paragraph 0077).
Regarding claim 11, Bevier teaches a composition comprising niosomes encapsulating a cannabinoid receptor binding agent (claim 13), which can be cannabidiol (i.e., at least one cannabinoid; page 14, paragraph 0147, table 2), and is aqueous (page 14, paragraph 0147, table 2), and exemplifies such niosomes to be 150-300 nm in size (i.e., smaller than 500 nm; Bevier, page 11, paragraph 0119, formulation 9). Bevier teaches nanoparticles may be coated with a polymer or polysaccharide (Bevier, page 5, paragraph 0057), and teaches natural polymers which can be cellulose (i.e., a beta-glucan as evidenced by Synytsya, table 1; Bevier, page 8, paragraph 0086). Bevier teaches the composition is for topical use (Bevier, page 1, paragraph 0002) and further teaches the use of excipients (Bevier, page 5, paragraph 0060) which should be compatible with the intended functionality (i.e., the excipient should be topically acceptable; Bevier, page 6, paragraph 0060).
Bevier does not specifically teach a polyglycerol which is esterified with a fatty acid, but does teach the use of non-ionic surfactants as permeation enhancers (Bevier, page 7, paragraph 0073) and further teaches permeation enhancers can be encapsulated within the vesicle with the cannabinoid (Bevier, page 5, paragraph 0051). Pacchetti teaches a topical composition comprising niosomes having a size of smaller than 500 nm and comprising a topically acceptable excipient (Pacchetti, abstract), wherein the niosomes comprise esters of linear or branched polyglycerols with saturated or monounsaturated linear fatty acids (Pacchetti, page 2, paragraph 0026). Pacchetti defines the esterified linear or branched polyglycerols as non-ionic surfactants (Pacchetti, claim 6).
Bevier further teaches glycols including propylene glycol (Bevier, page 8, paragraph 0085), but does not specify a glycol having from 4-16 carbon atoms. Pacchetti, however, teaches glycols including either propylene glycol and butylene glycol (i.e., a glycol with 4 carbon atoms; Pacchetti, page 4, paragraph 0077).
Bevier and Pacchetti do not measure an enhanced penetration as compared to a composition comprising a cannabinoid in an oil-based vehicle. However, Bevier teaches a vesicle such as a niosome serves as a penetration enhancer (Bevier, page 4, paragraph 0044). The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise. Therefore, absent evidence to the contrary, the composition of Bevier and Pacchetti would be expected to result in the claimed enhanced penetration.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Bevier to have included esters of linear or branched polyglycerols with saturated or monounsaturated linear fatty acids (Pacchetti, page 2, paragraph 0026) as taught by Pacchetti, because Bevier teaches the use of non-ionic surfactants to enhance permeation (Bevier, page 7, paragraph 0073), while Pacchetti teaches esters of linear or branched polyglycerols as particularly preferred surfactants in niosome production (Pacchetti, page 2, paragraph 0039). Further, it would have been obvious to utilize butylene glycol in place of the propylene glycol taught by Bevier, because Pacchetti teaches the two chemicals to be reasonable alternatives (Pacchetti, page 4, paragraph 0077).
Regarding claim 12, Bevier and Pacchetti together teach all the elements of the current invention as applied to claim 11. Bevier teaches the composition is in the form of a solution in water (i.e., an aqueous solution; Bevier, page 11, paragraph 0113, formulation 3).
Regarding claim 14, Bevier and Pacchetti together teach all the elements of the current invention as applied to claim 1. Bevier further teaches the composition comprises cannabidiol (Bevier, page 11, paragraph 0119, formulation 9).
Regarding claim 15, Bevier and Pacchetti together teach all the elements of the current invention as applied to claim 2. Bevier further teaches the composition comprises cannabidiol (Bevier, page 11, paragraph 0119, formulation 9).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Bevier (US 20130011484 A1) and Pacchetti (US 20170281481 A1; IDS reference, 08/31/2022) as applied to claims 1-3, 5-9, 11-12, 14-15, further in view of Blume (US 9211238 B2). The references were previously cited by the Examiner.
Regarding claim 10, Bevier and Pacchetti together teach all the elements of the current invention as applied to claim 9. Bevier teaches the use of glycols (Bevier, page 3, paragraph 0037) such as propylene glycol (Bevier, page 8, paragraph 0085), but does not specify a glycol having from 4-16 carbon atoms. Pacchetti teaches glycols to include both propylene glycol and butylene glycol (i.e., a glycol with 4 carbon atoms; Pacchetti, page 4, paragraph 0077), but does not specifically state the butylene glycol is 1,2-butanediol. Blume teaches vesicles such as niosomes (Blume, column 1, line 25) comprising polymers (Blume, column 5, line 31), fatty acids (Blume, column 3, line 44), and polysaccharides (Blume, column 6, line 14) for topical application (Blume, column 3, line 33), and further teaches suitable solvents include propylene glycol and 1,2-butylene glycol (i.e., 1,2-butanediol; Blume, column 7, lines 65-66).
Bevier, Pacchetti, and Blume are considered to be analogous to the claimed invention, because all are in the same field of topical compositions comprising niosomes comprising polymers. It would have been prima facie obvious to one of ordinary skill in the art to utilize butylene glycol in place of the propylene glycol taught by Bevier, because Pacchetti and Blume teach the two chemicals to be reasonable alternatives (Pacchetti, page 4, paragraph 0077).
New Claim Rejections - 35 USC § 103
Claims 18-23 are rejected under 35 U.S.C. 103 as being unpatentable over Bevier (US 20130011484 A1), further in view of Pacchetti (US 20170281481 A1; IDS reference, 08/31/2022), and evidenced by Synytsya (Annals of Translational Medicine, 2014), as applied to claims 1-3, 5-9, 11-12, and 14-15. The references were previously cited by the Examiner.
Regarding claim 18, Bevier and Pacchetti together teach all the elements of the current invention as applied to claim 1. Bevier and Pacchetti do not measure a deformability index as claimed. However, this is considered to be a property of the claimed invention. A chemical composition and its properties are inseparable. See MPEP § 2112.01(II). Therefore, the composition of Bevier and Pacchetti would be expected to result in the claimed deformability index.
Regarding claim 19, Bevier and Pacchetti together teach all the elements of the current invention as applied to claim 11. As above, Bevier does not specifically teach a polyglycerol as claimed, but does teach the use of non-ionic surfactants as permeation enhancers (Bevier, page 7, paragraph 0073) and further teaches permeation enhancers can be encapsulated within the vesicle with the cannabinoid (Bevier, page 5, paragraph 0051). Pacchetti teaches niosomes comprising esters of linear or branched polyglycerols with saturated or monounsaturated linear fatty acids (Pacchetti, page 2, paragraph 0026), and further teaches the polyglycerol is preferably triglycerol, tetraglycerol, hexaglycerol, octaglycerol, or decaglycerol (Pacchetti, page 2, paragraph 0042). Pacchetti defines the esterified linear or branched polyglycerols as non-ionic surfactants (Pacchetti, claim 6). As above, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Bevier to have included a preferred polyglycerol ester (Pacchetti, page 2, paragraph 0026) as taught by Pacchetti, because Bevier teaches the use of non-ionic surfactants to enhance permeation (Bevier, page 7, paragraph 0073), while Pacchetti teaches esters of linear or branched polyglycerols as particularly preferred surfactants in niosome production (Pacchetti, page 2, paragraph 0039).
Regarding claim 20, Bevier and Pacchetti together teach all the elements of the current invention as applied to claim 11. As above, Bevier does not specifically teach a polyglycerol which is esterified with a fatty acid, but does teach the use of non-ionic surfactants as permeation enhancers (Bevier, page 7, paragraph 0073) and further teaches permeation enhancers can be encapsulated within the vesicle with the cannabinoid (Bevier, page 5, paragraph 0051). Pacchetti, however, teaches esters of linear or branched polyglycerols with saturated or monounsaturated linear fatty acids (Pacchetti, page 2, paragraph 0026), wherein the fatty acid comprises a monocarboxylic acid having from 4-32 carbon atoms (Pacchetti, page 3, paragraph 0046). As above, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Bevier to have included a preferred polyglycerol/fatty acid ester (Pacchetti, page 2, paragraph 0026) as taught by Pacchetti, because Bevier teaches the use of non-ionic surfactants to enhance permeation (Bevier, page 7, paragraph 0073), while Pacchetti teaches that an ester of the two is particularly preferred for niosome production (Pacchetti, page 2, paragraph 0039).
Regarding claim 21, Bevier and Pacchetti together teach all the elements of the current invention as applied to claim 11. As above, Bevier does not specifically teach a polyglycerol which is esterified with a fatty, but does teach the use of non-ionic surfactants as permeation enhancers (Bevier, page 7, paragraph 0073) and further teaches permeation enhancers can be encapsulated within the vesicle with the cannabinoid (Bevier, page 5, paragraph 0051). Pacchetti, however, teaches esters of linear or branched polyglycerols with saturated or monounsaturated linear fatty acids (Pacchetti, page 2, paragraph 0026), wherein the fatty acid comprises a monocarboxylic acid having from 4-32 carbon atoms, including stearic acid (Pacchetti, page 3, paragraph 0044). As above, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Bevier to have included a preferred polyglycerol/fatty acid ester (Pacchetti, page 2, paragraph 0026) as taught by Pacchetti, because Bevier teaches the use of non-ionic surfactants to enhance permeation (Bevier, page 7, paragraph 0073), while Pacchetti teaches that an ester of the two is particularly preferred for niosome production (Pacchetti, page 2, paragraph 0039).
Regarding claim 22, Bevier and Pacchetti together teach all the elements of the current invention as applied to claim 11. As above, Bevier does not specifically teach a polyglycerol which is esterified with a fatty acid, but does teach the use of non-ionic surfactants as permeation enhancers (Bevier, page 7, paragraph 0073) and further teaches permeation enhancers can be encapsulated within the vesicle with the cannabinoid (Bevier, page 5, paragraph 0051). Pacchetti, however, teaches esters of linear or branched polyglycerols with saturated or monounsaturated linear fatty acids (Pacchetti, page 2, paragraph 0026), wherein the fatty acid comprises a monocarboxylic acid having from 4-32 carbon atoms, including myristoleic acid (Pacchetti, page 3, paragraph 0046). As above, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Bevier to have included a preferred polyglycerol/fatty acid ester (Pacchetti, page 2, paragraph 0026) as taught by Pacchetti, because Bevier teaches the use of non-ionic surfactants to enhance permeation (Bevier, page 7, paragraph 0073), while Pacchetti teaches that an ester of the two is particularly preferred for niosome production (Pacchetti, page 2, paragraph 0039).
Regarding claim 23, Bevier and Pacchetti together teach all the elements of the current invention as applied to claim 11. Bevier and Pacchetti do not measure a deformability index as claimed. However, this is considered to be a property of the claimed invention. A chemical composition and its properties are inseparable. See MPEP § 2112.01(II). Therefore, the composition of Bevier and Pacchetti would be expected to result in the claimed deformability index.
Conclusion
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.
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/C.P.J./Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
Prosecution Insights