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 .
DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on December 23, 2025 has been entered.
Status of the Claims
Claims 1, 3, 5-6, 8, 10, 12, 14, 16, 18, and 20-24 are currently pending and are examined on the merits herein.
Application Priority
This application filed 05/05/2019 claims priority to PCT/US2017/060248, filed 11/06/2017 and provisional application 62/418,756 filed 11/07/2016.
Information Disclosure Statement
No new information disclosure statement(s) (IDS) has been filed.
Response to Arguments
Applicant’s arguments over the 35 U.S.C. 103 rejection of claims 1, 3, 5-6, 10, 12, 14, 16, 18, and 20-24 over Kleidon et al. (WO 2016094810 A2) is not persuasive. The rejection is herewith maintained. Applicant argues the claimed topical formulation delivers a skin protecting/enhancing agent not encapsulated and a microencapsulated cannabinoid to the surface of the skin. Furthermore, the prior art does not teach a bimodal carrier.
In response, the Examiner points out that the prior art clearly teaches the encapsulation of the cannabionoid and further teaches microcapsules of compositions disclosed herein can further be processed into forms including but not limited to solids, powders, liquids, suspensions, gels, tablets, foods, lotions, cosmetics, and other forms discussed in this disclosure. [0098] Additionally, an encapsulated cannabinoid processed into forms including but not limited to solids, powders, liquids, suspensions, gels, tablets, foods, lotions, cosmetics. Additionally, Kleidon teaches the use of cannabinoids in cosmetics or personal care products, such as soaps (e.g., solid, bar, liquid, or foaming), hand sanitizer, lotions, massage oils masks, makeup, moisturizers, sunscreen provides benefits including reduction of inflammation in a subject [00110]. The teachings read on an encapsulated cannabionoid and a non-encapsulated skin protecting/enhancing agent.
Applicant’s arguments over the 35 U.S.C. 103 rejection of claim 8 over Kleidon et al. (WO 2016094810 A2), as applied to claims 1, 3, 5-6, 10, 12, 14, 16, 18, and 20-24 in view of Tripathi et al. (Analysis of free and bound aroma compounds of pomegranate (Punica granatum L.)LWT - Food Science and Technology Volume 59, Issue 1, November 2014, Pages 461-466) is not persuasive. The rejection is herewith maintained. Applicant’s argument over claim 8 rejections depends on the validity of the previous arguments which were not found persuasive.
The rejection is as below:
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 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.
Claims 1, 3, 5-6, 10, 12, 14, 16, 18, and 20-24 are rejected under 35 U.S.C. 103 as being unpatentable over Kleidon et al. (WO 2016094810 A2).
Kleidon et al. teaches a cannabinoid composition, encapsulated (e.g., microencapsulated) administered to a subject, such as through oral consumption or topical treatment. (abstract) Microencapsulation processes can be conducted with the aid of one or more emulsifiers or surfactants. Emulsifiers and surfactants can include but are not limited to saponins, sodium stearoyl lactylate, polysorbate 20, and combinations thereof. [00103] (reads on an emulsifier and wetting agent). Various antioxidants are taught by Kleidon et al. [0068] [0071]- [0076] [0079] [0081] [0083] [0085] [0088] -[0091] The formulations are taught to comprise compounds that relieve skin conditions, improve skin healing. [0081] [0082] Microcapsules of compositions disclosed herein can further be processed into forms including but not limited to solids, powders, liquids, suspensions, gels, tablets, foods, lotions, cosmetics, and other forms discussed in this disclosure. [0098] The reference does not require a lecithin or soy; phospholipids, skin penetration enhancers or solvents. The compositions of the present disclosure can be provided as cosmetics or personal care products, such as soaps (e.g., solid, bar, liquid, or foaming), hand sanitizer, lotions, massage oils masks, makeup, moisturizers, sunscreen [00110] Microcapsules of compositions disclosed herein can further be processed into forms including i.e. lotions, reads on a formulation having biomodal compatibility – an encapsulated cannabinoid and non-encapsulated skin/protection enhancing ingredient (i.e. a lotion). Cannabinoids utilized in the compositions disclosed herein include but are not limited to cannabigerol-type (CBG), cannabigerolic acid (CBGA), cannabigerolic acid monomethylether (CBGAM), cannabigerol monomethyl ether (CBGM), cannabichromene- type (CBC), cannabichromanon (CBCN), cannabichromenic acid (CBCA), cannabichromevarin-type (CBCV), cannabichromevarinic acid (CBCVA), cannabidiol-type (CBD), tetrahydrocannabinol-type (THC), iso-tetrahydrocannabinol-type (iso-THC), cannabinol-type (CBN), cannabinolic acid (CBNA), cannabinol methylether (CBNM), cannabinol-C4 (CBN-C4), cannabinol-C2 (CBN-C2), cannabiorcol (CBN-Ci), cannabinodiol (CBND), cannabielsoin-type (CBE), cannabielsoic acid A (CBEA-A), cannabielsoic acid B (CBEA-B), cannabicyclol-type (CBL), cannabicyclolic acid (CBLA), cannabicyclovarin (CBLV), cannabicitran-type (CBT), cannabitriol, cannabitriolvarin (CBTV), ethoxy- cannabitiolvarin (CBTVE), cannabivarin-type (CBV), cannabinodivarin (CBVD), tetrahydrocannabivarin-type (THCV), cannabidivarin-type (CBDV), cannabigerovarin-type (CBGV), cannabigerovarinic acid (CBGVA), cannabifuran (CBF), dehydrocannabifuran (DCBF), and cannabiripsol (CBR) cannabinoids. [0043] The compositions of the present disclosure can comprise one or more additional ingredients cacao (e.g., cacao powder, cacao butter) [0093] Compositions for administration to animals can be mixed into feed or water, prepared for spraying application (e.g., mixed in glycerin) [00113] Terpinene can be used as an antioxidant, an anti-inflammatory, an antimicrobial, an antiproliferative, to reduce oxidative stress. [0075]
While the reference teaches a topical formulation with an encapsulated cannabinoid used in cosmetics/lotions/suspensions for topical application comprising wetting/emulsifier ingredients, skin protection/enhancing ingredient, the reference fails to specify the amounts.
It would have been obvious to one of ordinary skill in the art at the time of filing to modify amount of the ingredients based on the generic teachings. . The motivation to modify the amount of cannabinoid and excipients comes from the teaching that the formulations are useful topically. Therefore, a skilled artisan would have reasonable expectation of success in modifying amounts to get the desired effect of treatment. Therefore, a skilled artisan would have reasonable expectation of successfully achieve modifying properties as taught by the prior art.
Claims 1 and 24 are product by process claims. It is well settled in patent law that product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. See MPEP § 2123. The court in In re Thorpe held, “even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” See 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). In this case, the method of making the composition as claimed does not render structural limitations to the claimed composition. Thus, the processes are not given patentable weight.
Claims 21-23 are drawn to methods of use of a composition claim. The method of treatment do not get patentable weight in the composition claim.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Kleidon et al. (WO 2016094810 A2), as applied to claims 1, 3, 5-6, 10, 12, 14, 16, 18, and 20-24 in view of Tripathi et al. (Analysis of free and bound aroma compounds of pomegranate (Punica granatum L.)LWT - Food Science and Technology Volume 59, Issue 1, November 2014, Pages 461-466).
Kleidon et al. is as applied above.
While Kleidon et al. teaches antioxidants such as terpinene, the reference fails to specify the antioxidants recited in claim 8.
Tripathi et al. is solely used to show that pomegranate contains terpinene.
It would have been obvious to one of ordinary skill in the art at the time of filing to incorporate pomegranate (Punica granatum L.) into the formulation. The motivation to incorporate pomegranate (Punica granatum L.) is because Kleidon et al. teaches the use of terpinene as an antioxidant and Tripathi et al. teaches pomegranate contains terpinene. Therefore, a skilled artisan would have reasonable expectation of success in successfully achieving similar efficacy and results.
Conclusion
No claims allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAYLA SOROUSH whose telephone number is (571)272-5008. The examiner can normally be reached on Monday thru Friday; 8:30 AM to 5:00 PM EST.
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/LAYLA SOROUSH/Primary Examiner, Art Unit 1622