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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8/21/2025 has been entered.
Election/Restrictions
Claims 31-32, 34, 39-45, 47 and 51 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/29/2024.
Response to Arguments
All of Applicant arguments/remarks filed 8//21/2025 and 10/22/2025 have been fully considered and are not persuasive. Applicant arguments filed 8/21/2025 are reiterated in the response filed 10/22/2025 as such the page numbers listed below are those found in the 10/22/2025 response.
Additional Claim Amendments and Support
On page 9, Applicant argues that the specification, tables 10-1/10-2, 11-1/11-2 and 12 shows that the instant invention had improved oral bioavailability compared to those formulations with MCT or olive oils.
Applicant data is not persuasive as there is no comparison with the closest prior art. The MCT formulations tested are not SEDDS, while those with tripropionin or tributyrin are SEDDS. However, as explained below Garti teaches SEDDS formulations comprising MCT, as such Applicants have not compared the instant invention with the closest prior art and Applicant have not explained how the data they have provided is closer prior art than Garti. Furthermore, the data presented does not provide for a proper side-by-side comparison has multiple variables have been changed. The type of oil used has been changed, along with the delivery system type (SEDDS vs non-Sedds).
Applicant’s remarks regarding tables 20 and 21 are not persuasive as no comparison with the closest prior art has been provided. The data presented is also not commensurate in scope with the instant claims. While the claims have been limited some to reflect the data presented, the experiments performed comprise THC, Cremophor RH40, PG, glycerin, PEG 400 and ethanol in specific amounts, however, the claims are generic and do not require this specific combination of ingredients.
On page 10, Applicant argues that table 2 shows that formulations without ethanol were more advantageous.
This is not persuasive. While the use of ethanol was show to be less advantageous, there is no comparison with the closest prior art. Garti teaches alternative equivalent solvents which can be used instead of ethanol, thus the data lacks a comparison with compositions containing ethanol alternatives.
103 Rejection over Garti and Lee
All of Applicant’s arguments pertaining to the Garti and Lee rejection have been fully considered and are not persuasive.
In summary, Applicant argues Lee does not teach how to achieve successful formulations with improved oral bioavailability and simply suggest that tripropionin or tributyrin with other MCT oils and does not differentiate between the two and the instant specification shows that the claimed oils provide superior properties over MCT.
This is not persuasive as the data presented in the specification was not persuasive as such the substitution of one oil for the other remains prima facie obvious.
Applicant remarks that the newly introduced feature of “confer the cannabinoid…” distinguishes the claimed subject matter from the prior art.
This is not persuasive, as discussed below the prior art makes obvious the claimed structure, therefore the composition claimed and the composition of the prior art are expected to have the same properties absent evidence to the contrary. The fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Applicant remarks that Garti and Lee teach away from the claimed formulations as they teach ethanol to be a preferred solvent for use.
This is not persuasive as Garti teaches that solvents other than ethanol can be used and the use of a non-preferred embodiment does not teach away as the prior art does not criticize or discredit using solvents which are not ethanol.
Applicant remarks that the exclusion of ethanol and the use of the specifically claimed oil would have minimal expectation of success and require undue experimentation.
This is not persuasive as Garti clearly teaches that solvents other than ethanol can be used, thus it’s obvious to use something other than ethanol with a reasonable expectation of success and undue experimentation and Lee teaches that MCT and the claimed oils are prima facie obvious and its obvious to substitute art recognized equivalents with a reasonable expectation of success and undue experimentation absent persuasive unexpected results.
Modified/Maintained 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.
Claim(s) 29, 52-58 and 60-62 is/are rejected under 35 U.S.C. 103 as being unpatentable over Garti (WO 2018/061007) and Lee (US 2017/0312244). Both references are cited on the 3/16/2022 IDS.
Regarding claim 29: Garti discloses cannabinoid-loaded formulations (Abs). The formulations comprises at least one oil, at least one hydrophilic surfactant, at least one co-surfactant and at least 0.1wt% of at least one cannabinoid (Garti – claim 1). Garti teaches the oil to be present in the formulation in amounts ranging from 0.5-20wt%, this overlaps with the claimed “at least 10wt%.”
Garti teaches that these formulations are self-assembled upon mixing the surfactants and the oil to form water-free reverse micelles. Upon dilution with water or aqueous diluent, water micelles or water-in-oil nanodroplets are forms, being about to invert into bicontinuous mesophases in the presence of an aqueous phase. Upon further dilution they undergo (umbrella type) inversion onto oil-in-water droplets. The transformation to O/W microemulsions is spontaneous, without the need to employ shearing, mechanical forces or excessive heating conditions (Pg. 4).
Regarding the structurant of claim 1 and 60: Garti teaches that the co-surfactant is capable of lowering the interfacial tension between an oil phase and an aqueous phase to almost zero (or zero) allowing for the formation of a homogenous mixture once the formulation is mixed with an aqueous liquid (pg. 5). It is noted that “almost zero” overlaps with the claimed “greater than 0”. Garti teaches that the co-surfactant can be polyols (Garti – claim 10). Suitable polyols for use include glycerol, propylene glycol and polyethylene glycol, these reads on the claimed structurants. These can be used in amounts ranging from 1-50%, preferably 5-45% (pg. 8 and table 1-1).
Regarding the surfactant of claim 1 and 58: Garti teaches the composition to comprise hydrophilic surfactants such as oleoyl macroglycerides, such as Labrafil M 1944 CS, reading on low-HLB polyoxyglycerides (pg. 7 and table 1-5) and these can be used in amounts ranging from 38-80% (pg. 8).
Regarding 1 and “does not contain ethanol”, Garti teaches that co-solvents can be included and these include at least one selected from ethanol, propanol, isopropyl alcohol, etc. (Garti – claim 14). Thus the use of a solvent other than ethanol is prima facie obvious as Garti lists about 9 alternatives that are equivalent to ethanol and thus would be obvious for use.
Regarding claim 52: Garti teaches the formulation to be free of water (Garti – claim 3).
Regarding claim 53: Garti teaches the cannabinoid to be at one of cannabigerolic acid, cannabigerolic acid monomethylether, cannabigerol (CBG), delta-9-tetrahydrocannabinol, etc. (Garti – claims 4-6).
Regarding claim 54: Garti teaches that mixture of oils can be added, this the use of 2 oils is prima facie obvious, reading on “comprising a second oil.” (pg. 7).
Regarding claim 55: Garti teaches that suitable oils for use include MCT, olive oil, sunflower oil, rapeseed oil, castor oil, etc. (pg. 7).
Regarding claim 56: Garti teaches that the oil(s) can be present in amounts ranging from 0.5-20% (pg. 7).
Regarding claim 61: Garti teaches the formulation to comprise at least one co-surfactant (i.e. structurant) (Garti – claim 10), as such it would have been prima facie obvious to use more than one, which reads on at least two with a reasonable expectation of success.
Regarding claim 62: Garti teaches the formulation to have an oil droplet size of 5-100nm, (pg. 12), Garti teaches that upon dilution with a suitable diluent , typically water for injection or saline, the concentrate spontaneously forms microemulsions (pg. 15). While Garti discusses microemulsions, these are taught to have a size of 5-100nm and the instant specification teaches nanoemulsions to be emulsions having a droplet size of 100-800nm, as such the microemulsions of Garti reads on nanoemulsions as claimed.
While Garti teaches that a suitable oil includes medium chain triglycerides (MCT), selected from a finite number of options (pg. 9 and 10-12 and table 1-1), Garti does not teach the oil to be tripropionin or tributyrin.
Lee teaches pharmaceutical formulations for oral administration which comprise MCTs. Exemplary MCTs include tripropionin and tributyrin (Lee – claim 5), selected from a finite number of options.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Garti with those of Lee. One of skill in the art would have been motivated to add tributyrin or tripropionin in the formulation of Garti as Lee teaches that these are types of MCT that are suitable for use in oral formulations and its prima facie obvious for a skilled artisan to pursue the known options within his or her own technical grasp and its prima facie obvious to combine oils individually taught to be used for the same purpose to create a new composition for the same purpose. One of skill in the art would have a reasonable expectation of success as Garti teaches using MCT and teaches the composition to be administered orally (pg. 17).
Claim 1 recites “ thus conferring…improved stability…” this is a recitation of a property of the claimed composition. The prior art makes obvious the claimed structure, therefore the composition claimed and the composition of the prior art are expected to have the same properties absent evidence to the contrary.
Conclusion
No claims are allowable.
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/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613