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 .
Response to Amendment
Applicant’s response of 12/04/2025 has been received and entered into the application file. Claims 19, 22-23, 25-33, 36-37, and 39-46 are pending in this 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 19, 22-23, 25-33, 36-37, and 39-46 are rejected under 35 U.S.C. 103 as being unpatentable over Blake (US 2020/0000721 A1), Dino et al. (WO 2016/007331 A1), Zhang et al. (Layered Double Hydroxide-Based Nanocarriers for Drug Delivery, pharmaceutics, 2014), and Naoi et al. (US 2020/0375874 A1, priority 04/26/2017).
Blake discloses compositions comprising rheology modifier comprising a water-swelling polymer and a co-emulsifier that are suitable for preparing cream formulation containing an oil (Abstract). The cream can comprise a plant extract such as cannabidiol (CBD) oil ([0018]). In one embodiment, the cannabis oil is a CBD oil that contains less than 10 ppm THC ([0056]). In one embodiment, the aqueous composition comprises between 1% and 5% (w/w) of the rheology modifier ([0044]). The oil can be between about 1% and 18% (w/w) of the composition ([0062]). The rheology modifier further comprises a carrier oil and an emollient. The rheology modifier can comprise an emollient that is not PPG-3 benzyl ether ethylhexanoate ([0046]). Blake discloses the use of emollient Crodamol SFX (PPG-3 Benzyl Ether Ethylhexanoate) in combination with glycerin resulted in improved skin feel and absorption characteristics relative to the other emollients ([0085]). Furthermore, one of ordinary skill in the art would experiment with different concentrations of an emollient within a skin formulation.
Blake does not explicitly mention organoclay with a quaternary ammonium cation.
Dino discloses an organoclay composition where a phyllosilicate clay is exchanged with quaternary ammonium ions having a formula of [NR1R2R3R4]+ wherein at least one of R1, R2 and R3 is a mixture of branched alkyl groups (Abstract). In one embodiment, an organoclay composition comprises: a phyllosilicate clay; and quaternary ammonium ions having a formula of [N-R1R2R3R4]+ wherein one or more of R1, R2 and R3 is a mixture of branched alkyl groups, each branched alkyl group having 12-22 total carbon atoms, a linear backbone and one or more C1 to C3 branching alkyl groups, wherein the branching alkyl groups are distributed at different carbon positions along the linear backbone of the branched alkyl group (page 2). Organoclays may be used in a variety of applications; as a rheology modifier and may be used as an additive in consumer products such as lipstick, deodorant, nail polish and the like (page 25, lines 20-24).
Above references do not disclose layered double hydroxide organoclay delivery system.
Zhang teaches that biocompatible clay materials have attracted particular attention as the efficient drug delivery systems (DDS). Zhang reviews developments in the use of layered double hydroxides (LDHs) for controlled drug release and delivery (Abstract). Some layered materials are excellent candidates for use in DDS since their lamellar structures provide a suitable interlayer spacing for drug molecules which can be incorporated, by a process such as ion-exchange. In the case of natural smectite type clays, cationic species may be intercalated in the interlayer galleries, whereas in the case of LDHs anionic species may be intercalated. LDHs/polymers/anions hybrid systems have been explored for pharmaceutical applications of LDHs especially involving the biocompatibility and toxicity of LDHs and anti-cancer drugs intercalated LDH materials (page 299). There are three main attractive features of LDH-based drug carriers: convenient synthesis, structural and morphological tunability, and their low toxicity and good biocompatibility (page 300). The synthesis of drug-LDH composite materials involves the assembly of organic ions/molecules in the interlayer galleries of the LDH host via electrostatic interactions or hydrogen bonds; in addition to the size of the guest species, arrangement (monolayer or bilayer), size, and orientation of the guests as well as the interactions between the negatively charged guest and positively charged host are all critical factions (page 301).
Naoi discloses a transparent composition having UV protection effect (Abstract). It is preferred that the composition contains an oil component thickener appropriate from materials that are used in cosmetics ([0068-0069]) such as amino acid-based gelling agents dibutyl lauroyl glutamide, dibutyl ethylhexanoyl glutamide, polyamide-8 ([0073]). Regarding claim 8, Naoi discloses vegetable oils that are often used in cosmetic compositions ([0082]). Naoi discloses vitamins A, B1, B2, B6, C, and E which are often included in cosmetic compositions ([0091]). Naoi discloses optional component polyglyceryl ester surfactants that can be used in cosmetic compositions ([0087]). Naoi teaches that the option component may be contained in amounts within a range where transparency of the composition is not impaired ([0081]). Additionally, one of ordinary skill in the art would experiment with various concentrations of a surfactant within a composition.
Blake discloses skin formulations comprising CBD, rheology modifier, emollient. Dino discloses organoclay exchanged with a quaternary ammonium cation. Zhang discloses LDHs for controlled drug release and delivery. Naoi discloses thickeners routinely used in cosmetics. Therefore, it would have been obvious to one of ordinary person in the art before the effective filing date of the claimed invention to have combined the skin formulation taught by Blake with organoclay and LDH for controlled drug delivery. This is taking some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Regarding claims 22-23 and 25-26, all the limitations are discussed above.
Regarding claim 27, Blake teaches moisturizers to be included such as squalene (Table 3).
Regarding claim 28, squalene is a plant-based emollient that can be derived from sugar cane and other plant sugar. Therefore, sugar derivatives are taught by Blake.
Regarding claim 29, Blake discloses ethylhexylglycerin to be included in the formulation ([0038]).
Regarding claim 30, Dino discloses film forming polymers are selected from the group consisting of sulfopolyester resins, water dispersible, noncrosslinked acrylic resins, polyvinyl acetate/polyvinyl alcohol resins, polyvinyl pyrrolidone (PVP), PVP/VA copolymers and mixtures thereof (page 27, lines 10-24).
Regarding claim 31, Blake discloses that the cream formulation comprises a medicinal ingredient – a natural or synthetic plant extract such as cannabis oil ([0073]). In one embodiment, the essential oil is prepared from cannabis, tea tree (melaleuca), frankincense, lavender, Melissa, sandalwood, cassia, cinnamon bark, clove, oregano, thyme, bergamot, black pepper, eucalyptus, ginger, and/or peppermint ([0053]).
Regarding claim 32, Zhang discloses the LDH materials have been assembled including antioxidant drugs (page 320). Naoi discloses antioxidants such as tocopherol, dibutylhydroxytoluene ([0092]).
Regarding claim 33, an active emulsified delivery system comprising a rheology modifier, emollient, polyglyceryl ester surfactant and more actives are discussed above.
Regarding claim 36-37 and 39-46, limitations of these claims are discussed above.
Response to Arguments
Applicant’s arguments filed 12/04/2025 have been fully considered but they are not persuasive.
On pages 8-11 of remarks, applicant argues that Blake does not disclose a rheology modifier (organoclay), and that Blake’s composition comprises a specific rheology modifier. Per MPEP 2145 (IV), Where a rejection of a claim is based on two or more references, a reply that is limited to what a subset of the applied references teaches or fails to teach, or that fails to address the combined teaching of the applied references may be considered to be an argument that attacks the reference(s) individually. Blake is relied upon to teach that rheology modifier, of any kind, is important when preparing a formulation comprising CBD; rheology modifier is linked to desirable sensory characteristics such as skin feel ([0026]). Blake shows, in Table 4, the importance of viscosity in such a formulation – 0.5% - 7.5% (w/w) concentrations of ViscOptima (rheology modifier) are experimented. Of note, 2%, 3%, 4%, and 5% concentrations showed suitable consistency; good mixing with oil (Table 4). One of ordinary skill in the art would immediately envisage that ~2-5% of rheology modifier within CBD formulation would prove to be useful, which falls within the range of claim 19 of instant application. Applicant argues that Blake requires the presence of a specific rheology modifier, but claim 19 does not exclude such a modifier. Additionally, Blake is not limited to only sodium polyacrylate. In one embodiment, the aqueous composition comprises a rheology modifier comprising sodium acrylate and a co-emulsifier, optionally a non-ionic surfactant. In some embodiments, the rheology modifier may also include an oil such as ethylhexyl cocoate and/or emollient such as PPG-3 benzyl ether myristate ([0016]). In Tables 1-3 of Blake, other components are used as thickeners such as cetearyl alcohol, jojoba flakes.
On page 12 of remarks, applicant argues that it is not obvious to include an organoclay in the compositions taught in Blake. However, Dino discloses that the organoclay compositions can be used in vegetable oil-based systems such as soybean oil, rapeseed oil, canola oil, palm oil, rice bran oil and the like. In one embodiment, the organoclay compositions of the present invention can be dispersed into the organic composition (such as CBD compositions) to provide improved viscosity characteristics (pg 26, lines 23-28). One of ordinary skill in the art would be motivated to use organoclays as additives in consumer products such as lipstick, deodorant, nail polish and the like as taught by Dino. The instant application also points to other rheology modifiers such as ethylcellulose, dibutyl lauroyl glutamide, dibutyl ethylhexanoyl glutamide which are taught by Naoi discussed above. The instant application does not show why the use of organoclay as a rheology modifier is superior to these other modifiers.
On page 13 of remarks, applicant argues that Dino’s composition would not be used in Blake’s composition. But as discussed above, one of ordinary skill in the art would be motivated to use organoclays as additives in consumer products such as lipstick, deodorant, nail polish and the like as taught by Dino, regardless of formulation types.
On page 14 of remarks, the applicant argues that Blake does not teach the emollient wt %. However, Naoi discloses that the composition can comprise an emollient (moisturizing agent) in an amount within a range where transparency of the composition is not impaired ([0081]). One of ordinary skill in the art would immediately envisage that the wt % or concentration of an emollient is routinely varied. Furthermore, the instant specification does not disclose any specific examples of the gelled delivery system to show why the 50-90 wt. % of an emollient is claimed.
Therefore, the rejection is maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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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/JOHN SEUNGJAI KWON/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615