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 .
Priority
The instant application was filed 15 June 2023 and is the national stage entry of PCT/EP2021/086077 filed 16 December 2021. The Applicant claims priority to foreign application IT102020000031379 filed 18 December 2020. An English copy of the foreign document has not been provided. Therefore, the effective filing date of the instant application is 16 December 2021.
Election/Restrictions
Claims 12 and 13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 09 March 2026.
Applicant's election with traverse of Group I (claims 1-11) in the reply filed on 09 March 2026 is acknowledged. The traversal is on the ground(s) that Moon does not teach niosomes. This is not found persuasive because Moon teaches lipid structured nanoparticles made from phospholipids, such as lecithin (para. 49), which is interpreted as a niosome based on Applicant’s description (instant specification, pg. 12). The Applicant defines niosome as a hydrophilic vesicle formed by a non-ionic surfactant.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 3, 4, 6-9 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moon (WO 2020209902 A1).
Regarding claim 1, Moon teaches topical compositions (para. 43; entire teaching) with lipid structured nanoparticles of encapsulated cannabinoids (paras. 17, 20), which are constructed from phospholipids, such as lecithin (para. 49), which is interpreted as a niosome (hydrophilic vesicle formed by a non-ionic surfactant) based on Applicant’s description (instant specification, pg. 7). Water may be used as a suitable solvent for the nanoparticles (para. 48). A pharmaceutically acceptable excipient may be included (para. 91). The nanoparticles may have a diameter of 1-500 nm (para. 6).
Regarding claim 3, the THC of the cannabinoids is obtained directly from cannabis (naturally) or made synthetically (para. 36).
Regarding claim 4, triglycerides (para. 50) is interpreted as made from a triglycerol group.
Regarding claim 6, the composition may include cellulose (para. 92), which is interpreted as a polysaccharide of natural origin.
Regarding claim 7, the composition may include propylene glycol (para. 92), which is interpreted as addressing a glycol with 4-16 carbons (iii).
Regarding claim 8, the formulation may be in the form of a liquid dosage (para. 96).
Regarding claim 9, the formulation may be an aqueous solution or emulsion (para. 96).
Regarding claim 10, the composition may include gelatin (para. 92).
Regarding claim 11, the amount of active may be 10-100 mg of THC (para. 25) and the composition may include a 10-300 mg dose (para. 9).
Moon does not specifically teach the water-based composition present in an amount of 0.5-20% in claim 11.
Regarding claim 11, the amount of active may be 10-100 mg of THC (para. 25) and the composition may include a 10-300 mg dose (para. 9). That being said and in lieu of objective evidence of unexpected results, the amount can be viewed as a variable that achieves the recognized result of successfully making the cannabinoid niosome composition, which a skilled artisan would have been easily motivated to modify and adjust based on the broad teachings of Moon. The optimum or workable range of the amount can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Applicants provide no evidence of any secondary consideration, such as unexpected results, that would render the optimized amounts of water-based composition as nonobvious.
Claim(s) 1-9 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moon (WO 2020209902 A1) and Sahle et al. (Polyglycerol fatty acid ester surfactant-based microemulsions for targeted delivery of ceramide AP into the stratum corneum: Formulation, characterization, in vitro release and penetration investigation, European Journal of Pharmaceutics and Biopharmaceutics, 2012).
In regards to claim(s) 1, 3, 4, 6-9, and 11, Moon, as applied supra, is herein applied in its entirety for its teachings of a cannabinoid niosome composition.
Moon does not specifically teach a linear or branched polyglycerol esterified with saturated or monounsaturated linear fatty acids in claims 2 and 5.
Sahle teaches that polyglyceryl fatty acid ester surfactants, such as polyglycerol-4 oleate (instant specification, pg. 8), helped to stabilize emulsion structures for topical drug delivery (abs, pg. 147).
Since Moon does not specifically teach a linear or branched polyglycerol esterified with saturated or monounsaturated linear fatty acids in claims 2 and 5, one of ordinary skill in the art would have been motivated to use Sahle’s teaching of using polyglyceryl fatty acid ester surfactants, such as polyglycerol-4 oleate (instant specification, pg. 8). Moon teaches emulsion compositions (para. 18) comprising cellulose (ii. polysaccharides) with surfactants that are known in the art (para. 50), and Sahle teaches that polyglycerol fatty acid ester surfactants may beneficially increase the stability of compositions formulated as emulsions. Therefore, a skilled artisan would have been led to combine the teachings to improve Moon’s teaching. “Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).”
Claim(s) 1-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moon (WO 2020209902 A1), Sahle et al. (Polyglycerol fatty acid ester surfactant-based microemulsions for targeted delivery of ceramide AP into the stratum corneum: Formulation, characterization, in vitro release and penetration investigation, European Journal of Pharmaceutics and Biopharmaceutics, 2012), and Ham (Designing and developing suppository formulations for anti-HIV drug delivery, Therapeutic Delivery, 2017).
In regards to claim(s) 1-9 and 11, Moon et al., as applied supra, is herein applied in its entirety for its teachings of a cannabinoid niosome composition.
Moon does not specifically teach their formulation in the form of a gel or cream-gel in claim 10.
Ham teaches that gelatin suppositories dissolve slowly and provide long term release of active ingredients (pg. 810).
Since Moon does not specifically teach their formulation in the form of a gel or cream-gel in claim 10, one of ordinary skill in the art would have been motivated to use Ham’s teaching of gelatin suppositories for long term release of active ingredients. Moon teaches suppositories (abs) for controlled release of active ingredients (para. 48), as well as gelatin in their composition (para. 92). It is interpreted that enough gelatin would create a gelatinous consistency. Therefore, a skilled artisan would have been led to combine the teachings to improve Moon’s teaching and form a gel product. “Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).”
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 6, 9, 11, 12 of copending Application No. 17/905,387 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claim 1 recites a topical formulation comprising cannabinoids in niosomes with a particle size of less than 500 nm and an excipient. Claims 1 and 11 of the reference application recites a topical composition comprising a cannabinoid in a niosome with a particle size smaller than 500 nm and an excipient. The niosomes comprise an esterified polyglyerol that is not chemically linked to the cannabinoid. Therefore, instant claim 1 is considered not patentably distinct over claims 1 and 11 of the reference application.
Instant claims 2 and 4 recite a niosome with an esterified polyglyerol and a polysaccharide with a glycerol, tetraglycerol, hexaglycerol, etc. group. Claims 1 and 5 recite an esterified polyglycerol with a triglycerol, tetraglycerol, hexaglycerol, etc. group. Therefore, instant claims 2 and 4 are considered not patentably distinct over claims 1 and 5 of the reference application.
Instant claim 3 recites a natural or synthetic cannabinoid. Claim 2 of the reference application recites a cannabinoid of natural or synthetic origin. Therefore, instant claim 3 is considered not patentably distinct over claim 2 of the reference application.
Instant claim 5 recites polyglycerol with fatty acids with 4-32 carbons. Claim 6 of the reference application recites fatty acids with 4-32 carbons. Therefore, instant claim 5 is considered not patentably distinct over claim 6 of the reference application.
Instant claim 6 recites a natural polysaccharide and claim 3 of the reference application recites a natural polysaccharide. Therefore, instant claim 6 is considered not patentably distinct over claim 3 of the reference application.
Instant claim 7 recites a glycol with 4-16 carbons and claim 9 of the reference application recites a glycol with 4-16 carbons. Therefore, instant claim 7 is considered not patentably distinct over claim 9 of the reference application.
Instant claims 8 and 9 recite a liquid or semi-solid form, a solution, emulsion, etc. Insatnt claim 10 recites a gel or cream-gel form. Claim 12 of the reference application recites an aqueous solution or dispersion, where gel is interpreted as a type of dispersion. Therefore, instant claims 8 and 9 are considered not patentably distinct over claim 12 of the reference application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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