DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Claims Status
Amendments to the Specification and Claims filed 05 May 2023 are acknowledged, claim multiple dependencies have been corrected and no new subject matter has been added.
Claims 1-18 are pending and under current examination in this application.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. § 102(b)(2)(C) for any potential 35 U.S.C. § 102(a)(2) prior art against the later invention.
Claims 1-18 are rejected under 35 U.S.C. § 103 as being unpatentable over Heller (WO2018204326A1; published 08 November 2018) in view of Elsohly (WO2003101357A1; published 11 December 2003).
Regarding instant claims 1, 4, 6, 13 and 15, Heller teaches a composition comprising at least one cannabinoid and permeation enhancer (i.e., terpene) encapsulated in a water-soluble polymer matrix (claim 1), wherein the cannabinoids can be chosen from THC (delta-9-tetrahydrocannabinol), THCV (tetrahydrocannabivarin), CBD (cannabidiol), CBG (cannabigerol), CBN (cannabinol), CBC (cannabichromene), or (claim 2) and sodium alginate as the polymer matrix for cannabinoid encapsulation (¶[00270]) with a viscosity ranging from 0.3 to 250,000 centipoise (cP) (¶[0040]), encompassing a medium viscosity sodium alginate (240-3500 mPas, equivalent to 240-3500 cP).
In addition, Heller teaches wherein cannabinoids and terpene permeation enhancers can be used together ¶[0013]-[0035], or individually (cannabinoids only ¶[0036]; encapsulated terpene permeation enhancers only ¶[0039]) and can be recombine for use in desired ratios (¶[0017]), wherein “any ratios of sufficiently pure cannabinoids and terpenes can be utilized” (¶[0027]), which would encompass the instant claim 7 and 17 range limitation of a molar ratio cannabinoids to permeation enhancer is from about 20:1 to about 1:20 [93.6-94.4% cannabinoids to 5.6-6.4% permeation enhancer to 3.5-4.0% cannabinoids to 96.0-96.5% permeation enhancer, based on the MW range of THCV to CBND and deoxycholic acid]. He further describes where cannabinoids and terpene permeation enhancer can be encapsulated separately or together (¶[0039]- [0040]); ¶[00298]-[00318] separately and ¶[00319]-[00333] together as cannabis oils), as in the limitations of instant claims 2, 9 and 10.
Regarding instant claim 8, 11, 12 and 16, Heller teaches a process for embedding encapsulated cannabinoids (which can include cannabinoids only or terpene permeation enhancers only wherein regardless of whether the components are derived from cannabinoids or terpenes they can be introduced to and dispersed in a polymeric mixture for encapsulation (¶[0040])) in a sodium alginate matrix by mixing an aqueous solution cannabinoid and alginate polymer to form an emulsion (¶[00298]-[00308]), then casting the emulsion into an aqueous solution of the multivalent salt calcium chloride (¶[00313]-[00315]). Heller further teaches the process with a mixture of the permeation enhancer and cannabinoids in the form of cannabis oil using medium chain triglycerides (MCT) as a carrier oil solvent for solubilizing the cannabinoids, as routine in the art (¶[00319]-[00323]).
Heller does not explicitly teach mixing encapsulated cannabinoids and encapsulated terpene permeation enhancers after they have been produced in the processing steps described in ¶[00298]-[00308], but does indicate that it is possible to separate the active ingredients (wherein both cannabinoids and terpene permeation enhancer are considered active ingredients (¶[0011])) into their individual components and then recombine them in the desired ratios (¶[0017]), indicating that the encapsulated permeation enhancer and encapsulated cannabinoid particle can be mixed together after they are produced individually and this is an obvious variant.
Regarding instant claim 3 and 18, Heller teaches applications of the invention to deliver effective amounts of the composition by different routes of administration (¶[00369]-[00395]), more specifically sublingual and buccal dosage forms intended to increase penetration/permeation and bioavailability (¶[00370), having a 5–20-minute first onset of action (¶[00371]-[00378]) and “…a consumer who ingests the cannabinoid, terpene, essential oil, etc., that was formerly encapsulated and dissolved as described herein may experience the onset of an effect of a cannabinoid acting on cannabinoid receptors in cells that alter neurotransmitter release in the brain within 30 min of ingestion.” (¶[[0004]), indicating rapid effects which would be expected to produce a corresponding rapid pharmacological Tmax(brain) of ≤ 1 hour based on known absorption profiles.
Heller teaches alternate embodiments may include other penetration enhancers [00362] and immunostimulatory additives ¶[00363], however does not explicitly specify the use of bile acid as a permeation enhancer or immunostimulant and therefore does not teach the specific limitation of instant claims 1-18, wherein the permeation enhancer is bile acid, or more specifically deoxycholic acid per the limitation of instant claims 5 and 14.
Elsohly teaches a transmucosally delivering a cannabinoid preparation wherein, “The transmucosal preparation will preferably contain a 'penetration enhancer' (which may also be referred to as an absorption enhancer or permeability enhancer). These penetration enhancers may include bile salts, such as sodium deoxycholate [sodium salt of deoxycholic acid], sodium glycodeoxycholate, sodium taurocholate and sodium glycocholate…” (page 9, last paragraph). Further, deoxycholic acid is a well-known bile acid used as a permeation enhancer and it had been disclosed at the time of the claimed invention that, “A combination of drug-bile acid and microencapsulation methods can be one promising strategy to improve the oral delivery of lipophilic drugs.” as evidence in the Abstract by Wagle (evidentiary reference: Wagle, et al. Alginate-based drug oral targeting using bio-micro/nano encapsulation technologies. Expert Opinion on Drug Delivery, 17(10), 1361–1376; published online 23 September 2020).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to substitute deoxycholic acid as a permeation enhancer taught by Elsohly for the terpene permeation enhancer in the invention taught by Heller to arrive at the claimed composition and process with a reasonable expectation of success, since deoxycholic acid was known and used in the art to enhance drug delivery for cannabinoids. One would be motivated to make the substitution to further optimize brain onset speed, permeation enhancement and improve shelf-life compared to more volatile and oxidation prone terpenes.
Conclusion
No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA L. SCOTLAND whose telephone number is (571) 272-2979. The examiner can normally be reached M-F 9:00 am to 5:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached at (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/RL Scotland/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615