DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-19, drawn to a composition) in the reply filed on 5/26/2026 is acknowledged. The traversal is on the ground(s) that the cited references do not make obvious a hydrophilic core-multishell nanocarrier comprising a hyperbranched dendritic polyglycerol polymer and a cannabis active agent. This is not found persuasive because the shared technical feature of the claims as amended is a hydrophilic nanocarrier comprising a core-multishell nanocarrier comprising a hyperbranched dendritic polymer and a cannabinoid (see independent claim 24). Additionally, the recitation of a hydrophilic core-multishell nanocarrier comprising a hyperbranched dendritic polyglycerol is known in the art. Fleige et al. (2013) (cited on the 8/14/2024 IDS) teaches core-multishell (CMS) nanocarriers comprising dendritic polyglycerol [Abstract; pg.2] that may be used as drug delivery platforms for both hydrophilic and hydrophobic molecules [Introduction]. It would be obvious to modify the CMS nanocarriers of Fleige to encapsulate a drug molecule of interest, such as an active cannabinoid agent. Fleige also teaches that use of polyglycerol dendrons results in cavities in the nanocarrier structure, allowing for increased transport capacity [pg. 2] Thus, it would also be obvious to modify the teachings of Aljayyoussi (cited in the Restriction Requirement dated 3/26/2026) with that of Fleige to arrive at the claimed technical feature as amended, in order to achieve a greater drug transport capacity. The requirement is still deemed proper and is therefore made FINAL.
Claims 20 and 24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 5/26/2026.
Specification
The disclosure is objected to because of the following informalities:
Pg. 13 recites “Middle chain triglycerids” instead of “Middle chain triglycerides”
Pg. 16 recites “aspartam” instead of “aspartame”
Pg. 16 recites “glas vials” instead of “glass vials”
Pg. 25 para. 6 recites “ethanol ad 100%”
Pg. 26 #2 recites “und” instead of “and”
Appropriate correction is required.
The use of terms such as DendroSol and Sativex, which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore, the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 5 and 8 are objected to because of the following informalities:
Claim 5 recites “CBC (cannobichromene),,”.
Claim 8 recites “comprising b) THC and CBD”. Examiner suggests amending to “wherein the plurality of cannabis active agents comprises THC and CBD” to avoid confusion over the alphabetical listing/grouping of elements.
Appropriate correction is required.
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 5 and 10-19 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.
Claim 5 recites “wherein the cannabis active agent is THC (tetrahydrocannabinol), … THCP (tetrahydrocannabiphorol) and CBDV (cannabidivarin) or a synthetic cannabinoid selected from the group comprising Nabilone (synthetic THC), biosynthetic cannabigerol, biosynthetic cannabidiol, and synthetic THCV, or a terpene selected from the group comprising β-myrcene, … bisabolol and (E)-β-farnesene.”
The use of “and” in the first set of cannabis active agents, followed by the two groupings of synthetic cannabinoids and terpenes which are seemingly expressed in the alternative (i.e. “selected from”) creates confusion as to whether all the compounds listed in the first set of cannabis active agents are required to be present, or if they may be also selected in the alternative. Additionally, the recitations of “selected from the group comprising … and” are improper Markush language and render the claim indefinite. "Comprising" is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim. MPEP 2111.03. A "Markush" claim recites a list of alternatively useable members. If a Markush grouping requires a material selected from an open list of alternatives (e.g., selected from a group "comprising of" the recited alternatives), then the claim is unclear as to what other alternatives are intended to be encompassed by the claim. See In re Kiely, 2022 USPQ2d 532 at 2* (Fed. Cir. 2022). When materials recited in a claim are so related as to constitute a proper Markush groups, listed alternatives may be set forth in a Markush grouping as "a material selected from the group consisting of A, B, and C" or "wherein the material is A, B, or C". MPEP 2173.05(h).
Claim 5 also recites “the cannabis active agent”. There is insufficient antecedent basis for this limitation in the claim. Claim 5 depends from claim 1, which recites “a plurality of cannabis active agents”. Therefore, it is unclear if “the cannabis active agent” refers to one cannabis active agent, more than one cannabis active agent, or all cannabis active agents within the plurality of claim 1.
The parenthetical recitation of “(synthetic THC)” also renders the claim indefinite because it is unclear whether the recitation in parentheses is part of the claimed invention. Since Nabilone is structurally distinct from THC, and there is more than one variation of synthetic THC (see Vuckovic pg. 4), the parenthetical casts confusion as to the scope of the claim.
For purposes of compact prosecution, the instant limitation is being interpreted to read “wherein at least one cannabis active agent comprises THC (tetrahydrocannabinol), CBD (cannabidiol), … THCP (tetrahydrocannabiphorol), or CBDV (cannabidivarin); or a synthetic cannabinoid selected from Nabilone, biosynthetic cannabigerol, biosynthetic cannabidiol, or synthetic THCV; or a terpene selected from β-myrcene, β -caryophyllene, … bisabolol, or (E)-β-farnesene.” Examiner also suggests that breaking the groups of compounds into a listed format may be helpful for clarity and readability, for example, “wherein at least one cannabis active agent is (a) selected from …. ; or (b) a synthetic cannabinoid selected from … ; or (c) a terpene selected from …”
Claim 10 recites the limitation "the ratio of THC to CBD". There is insufficient antecedent basis for this limitation in the claim.
Claims 11-17 recite the limitation "the nanocarrier". There is insufficient antecedent basis for this limitation in these claims, as these claims depend from parent claim 1 which recites both “a hydrophilic nanocarrier” and “a core-multishell-nanocarrier”.
Claim 11 recites the limitation "the CBD". There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the THC". There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites “ethanol ad 100%”. This renders the claim indefinite because it is unclear what “ad” means. It is unclear if “ad” was a typographical error and the intent was to write “at” or “ab” (as an abbreviation for “about”). Alternatively, a cursory search suggests that “ad” is used in German to indicate an amount “up to” a certain value. For purposes of compact prosecution, this limitation will be interpreted to read “ethanol up to 100%”.
Claim 19 recites “selected from the group comprising a mucoadhesive agent, a flavouring agent and a palatability enhancer.” As discussed above in the 112(b) rejection of claim 5, the recitation of “selected from the group comprising … and” is improper Markush language and renders the claim indefinite. The language creates confusion as to which elements are required parts of the invention and as to what other alternatives are intended to be encompassed by the claim. For purposes of compact prosecution, the instant limitation is being interpreted to read “selected from a mucoadhesive agent, a flavouring agent, or a palatability enhancer.”
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, 5-11 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Tomalia et al. (WO 2021/257626A1, effectively filed 6/20/2020).
Regarding claims 1 and 5-8, Tomalia teaches hyperbranched/dendritic polymeric host compounds (i.e. nanocarriers) for encapsulation of water-insoluble compounds such as cannabinoids [Brief Summary of the Invention pg. 5-6]. Tomalia defines dendritic polymers as an architectural polymer class including core-shell dendrimers, and discloses that dendrimer generation is indicated by the number of concentric branch shells surrounding the dendrimer core (i.e. multishell) [pg. 14]. The polymeric host compounds may comprise of poly(hydroxylic) compounds including glycerol [pg. 22 line 28-pg. 23 line 2]. Tomalia further teaches that the hyperbranched/dendritic polymeric host compound is suitable for solubilizing cannabinoids [pg. 6 line 1-2], including THC, CBD, CBN, CBNA, CBG, CBC, TCHV, and CBDV [pg. 13 line 20-pg. 14 line 4]. The nanocarriers of Tomalia may be used to incorporate any guest molecules that can spatially fit the interior cavity of the nanocarrier [pg. 57 Example 17]. Thus, it would be obvious to select any combination of cannabinoid guest molecules taught to be suitable for the invention.
Regarding claims 2 and 3, Tomalia teaches that the hyperbranched/dendritic polymeric host compound may be prepared with a solubilizing agent such as ethanol [pg 23. line 27-29].
Regarding claims 9 and 10, Tomalia teaches that the hyperbranched/dendritic polymeric host compound provides protection against external oxidative and photolytic degradation of enclosed cannabinoids [pg. 6 line 1-5]. Tomalia does not explicitly discuss the stability of encapsulated cannabinoids over a period of six months of more, however, the instant limitations recite properties of the claimed composition. Since Tomalia makes obvious the claimed composition, and a composition and its properties are inseparable, the claimed properties are presumed to be inherent. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. See MPEP 2112.01.
Regarding claim 11, Tomalia teaches that guest molecules may be confined in nanocarrier host compound by encapsulation, hydrophobic association, van der Waals association, hydrogen bonding, ionic forces, and dipolar interactions (i.e. non-covalent associations) [pg. 6 line 24-29].
Regarding claim 19, Tomalia teaches that the hyperbranched/dendritic polymeric host compound may be used for the delivery of flavors [pg. 24 line 18].
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Tomalia et al. (WO 2021/257626A1, effectively filed 6/20/2020), as applied to claim 1 above, and further in view of Deng et al. (US 2018/0256480 A1, published 9/13/2018)
Regarding claim 13, Tomalia does not explicitly teach a nanocarrier that is a hyperbranched dendritic polglycerol-polylactate copolymer. Deng teaches a topical formulation comprising core-shell nanoparticles with a hydrophobic core and a shell/coating of hyperbranched polymers (HPs) [Abstract]. Deng further teaches that the HP shell may be hyperbranched polyglycerol (HPG) coupled to polylactic acid (PLA) (i.e. polylactate, see Scifinder Substance Detail) to form a PLA-HPG copolymer [0092; 0101; 0175].
Deng teaches that the HP shell of the nanoparticles may be chemically modified to form functional groups that can interact with functional groups of tissue/cells, resulting in bioadhesive nanoparticles [0013]. PLA-HPG copolymer, for example, can be functionalized by coupling its hydroxyl groups with a carboxylic group on a ligand [0121]. Deng also teaches that PLA-HPG is a preferred shell material due to its chemical properties that allow for better resistance to non-specific adsorption to biomolecules, its biodegradability, and its long history of clinical use [0178-0179]. Thus, it would be obvious to one of ordinary skill, before the effective filing date of the instantly claimed invention, to modify the teachings of Tomalia with that of Deng, to modify the hyperbranched/dendritic polymeric host compounds of Tomalia to have PLA-HPG shell. A skilled artisan would make this modification with a reasonable expectation of success as the prior art teaches PLA-HPG to be a suitable material for such nanocarrier structures, and be motivated to make this modification as Deng teaches that these bioadhesive nanoparticles have the advantage of being able to adhere to the skin or other material, wherein they are retained at the site of injury to provide sustained treatment [0244].
Claims 1, 5-8, 11-12, and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Fleige et al. (US 2018/0344857A1, published 12/6/2018) and Vuckovic et al. (2018).
Regarding claim 1, Fleige teaches a pharmaceutical composition comprising a hydrophilic nanocarrier comprising a hyperbranched dendritic polyglycerol polymer and an analgesic [claim 1]. The analgesic of the composition mainly has a peripheral effect and thus reduces side effects triggered by the activation of central or intestinal opioid receptors [Abstract]. Fleige teaches that the nanocarriers of the composition can be loaded with a variety of guest molecules, such as opioid analgesics [0012], but does not explicitly teach cannabis active agents. Vuckovic teaches that cannabinoids act as analgesics [pg. 1] and that stimulation of the endocannabinoid system presents a promising approach that may prevent the occurrence of CNS side effects [pg 6]. Thus, the analgesic of Fleige and cannabinoid compounds are taught in the prior art to have equivalent functions. Substituting equivalents known for the same purpose is prima facie obvious. MPEP 2144.06. Thus, it would be obvious to modify the teachings of Fleige with that of Vuckovic and substitute the analgesic of Fleige with cannabinoid compounds and arrive at the instantly claimed composition.
Regarding claims 5-8, Vuckovic teaches that cannabinoid compounds with analgesic effects include CBD, THC, CBC, CBC, and THCV [pg. 3]. In particular, THC and CBD have been demonstrated to act synergistically in contributing to an analgesic effect [pg. 3]. It would be obvious to select any combination of cannabinoids taught to be suitable for providing an analgesic effect.
Regarding claims 11 and 12, Fleige teaches that the analgesic of the composition can be non-covalently associated [0012] or covalently associated with the nanocarrier [0016]. It would be obvious to select from any of the cannabinoids taught to be suitable as analgesics and couple them to the nanocarrier in either of the two ways taught by the prior art.
Regarding claim 14, Fleige teaches that the nanocarrier preferably has a dendritic core and at least two shells, wherein an inner shell is connected through a first linker with the dendritic core and an outer shell is connected to the inner shell through a second linker [0029].
Regarding claims 15-16, Fleige teaches that the nanocarrier preferably has a molecular weight of 1,000 to 100,000 g/mol. The MW taught by Fleige explicitly reads on the limitations of claim 15. Regarding claim 16, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985).
Claims 14 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Tomalia et al. (WO 2021/257626A1, effectively filed 6/20/2020), as applied to claims 1-2 above, and further in view of More (US 2017/0143675 A1, published 5/25/2017, cited on the 2/27/2026 IDS).
Regarding claim 14, Tomalia does not explicitly disclose a nanocarrier with a dendritic core and at least two shells, wherein an inner shell is coupled to the dendritic core via a first linker, and an outer shell is coupled to the inner shell via a second linker. More teaches a composition formulated for transdermal administration comprising a nanocarrier with a dendritic core and at least two shells, wherein an inner shell is coupled to the dendritic core via a first linker, and an outer shell is coupled to the inner shell via a second linker [Abstract]. The dendritic nanocarrier can comprise of hyperbranched polyglycerol (hPG) [0023-0024]. More teaches that this type of nanocarrier structure is preferable when the nanocarrier serves the function of an emulsifier or penetration modulator in the composition [0022]. Thus, it would be obvious to one of ordinary skill, before the effective filing sate of the claimed invention, to modify the teachings of Tomalia with that of More to formulate the polymeric host compound of Tomalia with the multi-shell structure of More, in order to improve the drug-release kinetics/profile and assist with overcoming the dermal barrier [0025].
Regarding claim 17, More teaches that the nanocarrier may comprise 0.05% to 25% by weight of the composition [0028; claim 15]. Where the range taught in the prior art overlaps with the claimed range, a prima facie case of obviousness exists.
Claims 4 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Tomalia et al. (WO 2021/257626A1, effectively filed 6/20/2020) and More (US 2017/0143675 A1, published 5/25/2017, cited on the 2/27/2026 IDS), as applied to claims 14 and 17 above, and further in view of Whittle et al. (US 2003/0021752 A1, published 1/30/2003, corresponding US Patent cited on the 8/14/2024 IDS).
Regarding claim 4, this claim recites the limitation wherein the composition comprises 5%-15% by weight of the core-multishell nanocarrier. More teaches that the nanocarrier may comprise from 0.05% to 25% by weight of the composition [0028; claim 15]. This limitation has been previously made obvious in the 103 rejection of claims 14 and 17; said discussion regarding a nanocarrier composition made obvious over Tomalia and More will be not repeated herein.
Claim 4 also recites the limitation wherein the composition comprises 40-90% alcohol. More teaches that the nanocarrier composition may comprise additional ingredients, such as a carrier comprising ethanol [0029]. More does not explicitly teach alcohol in the amount of 40-90% by weight of the composition. Whittle teaches the transmucosal administration of a lipophilic medicament comprising cannabinoids [Abstract]. The medicament of Whittle comprises of the lipophilic medicament, a self-emulsifying agent, and a mixture of solvents [0056]. Whittle further teaches that transmucosal absorption requires that the cannabinoid be brought into close contact with the surface of mucosal cells [0087], thus, adhesion to the mucosa for a sufficient time is important for controlled release and absorption of the drug agent [0087-0089]. Whittle discloses that ethanol is a suitable solvent for cannabinoid medicament, however, too high of an ethanol concentration produces a stinging sensation that is unpleasant when the medicament is administered transmucosally [0025].
While the composition of Whittle is not explicitly stated to comprise of a core-multishell, hyperbranched polyglycerol nanocarrier, these three references all aim to address the same problems relating to drug solubility and absorption/delivery. Tomalia further teaches that its polymeric nanocarriers are suitable for transmucosal administration (see pg. 9-10 which lists rectal and vaginal administration, i.e. transmucosal). Thus, the teachings of Whittle may be properly applied to those of Tomalia and More. See MPEP 2143(I)(C). Thus, it would be obvious to one of ordinary skill, before the effective filing date of the claimed invention, to modify the composition made obvious by Tomalia and More, with the teachings of Whittle, in order to optimize the amount of ethanol to avoid provoking a stinging sensation when the composition is administered transmucosally [0025-0026]. Whittle further teaches that in a preferred embodiment, the formulation comprises ethanol as a solvent and propylene glycol as a cosolvent in a ratio ranging from 4:1 to 1:4 [0069]. The total amount of so-solvent present in the formulation may be greater than 55% [0056]. Assuming that the total solvent is present in an amount of 55%, this equates to ethanol being present in the composition in an amount of 44% when the ratio of ethanol to polyethylene glycol is 4:1. Where the amounts taught in the prior art overlap with the instantly claimed range, a prima facie case of obviousness exists. MPEP 2144.05.
Regarding claim 18, this claim recites limitations that have been previously addressed and made obvious. The analysis for these limitations will not be repeated herein.
Regarding claim 19, Whittle teaches that viscolising agents with adhesive properties may be added to the formulation to improve facilitate adhesion to the epithelium of the oral cavity (reads on mucoadhesive agent) [0088]. Whittle also teaches that the medicament composition may comprise of flavorings [0073].
Conclusion
No claims are allowed.
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/AMANDA LYNN CHI/Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
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