DETAILED ACTION
This office action is in response to the Applicant’s filing dated April 27th, 2026.
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 .
Priority
This application is a 371 of PCT/US2022/031456 filed on May 27th, 2022; and has a PRO of 63/254,438 filed on October 11th, 2021 and 63/194,816 filed on May 28th, 2021.
Status of Claims
Claims 1-3, 7-8, 11, 24, 26, 28, 31, 34, 39, 47-48, 50, 56, 83, 97, 99 and 104 are pending in the instant application. Acknowledgement is made of Applicant’s remarks and amendments filed on April 27th, 2026. Acknowledgment is made of Applicant’s amendment of claims 97 and 104.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on April 27th, 2026 is acknowledged.
Claims 97, 99 and 104 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim.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 April 27th, 2026.
Applicant’s election of species without traverse of the active ingredient 6,6,9-trimethyl-3-pentyl-6a,7,8,10a-tetrahydro6H-benzo[c]chromene-1-ol (herein referred to as THC) shown below:
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as well as the carbohydrate pentane-1,2,3,4,5-pentol (herein referred to as xylitol) and the solvent propane-1,2-diol (herein referred to as propylene glycol) in the reply filed on April 27th, 2026 is acknowledged.
Claims 8, 11, 34, 39 and 56 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on April 27th, 2026.
A prior art search was conducted for the elected species.
This search retrieved prior art.
Therefore, the Examiner’s search will not be extended unnecessarily to additional species in/for/during this Office action.
Claims 1-3, 7, 24, 26, 28, 31, 47-48, 50 and 83 read on the elected species and will be examined herein.
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.
Claims 1-3, 7, 24, 26, 28, 31, 47-48, 50 and 83 are rejected under 35 U.S.C. 103 as being unpatentable over Brunn et al (CA 3040547 A1); as evidenced by Mardawati et al (Industria: Jurnal Teknologi dan Manajemen Agroindustri. (2020), 9, 17-24), cited for evidentiary purposes only; further evidenced by Huestis (Chem Biodivers, (2007), 4(8), 1770-1804), cited for evidentiary purposes only; further evidenced by AGC Chemicals (https://www.agc-chemicals.com/jp/en/products/detail/index.html?pCode=JP-EN-U002; Internet Archive Wayback Machine; November 19th, 2019; captured on June 24th, 2026), cited for evidentiary purposes only; further evidenced by Laroui et al (American Journal of Physiology - Gastrointestinal and Liver Physiology, (2010), 300, G371-G383), cited for evidentiary purposes only.
Regarding claims 1-3, 7, 24, 26, 28, 31, 50 and 83, Brunn teaches a master granule comprising one or more solid particles coated in a thin layer of cannabinoids (page 10, lines 28-31). Brunn teaches that the solid particles comprise sugar alcohols including xylitol (page 12, lines 26-30; page 13, lines 1-5) making up more than 80-95% by weight of the composition (page 14, lines 1-10), which is known in the art as having a solubility of 169g per 100g of water at 20°C (corresponding to 1690g/L) as evidenced by Mardawati et al (page 18, Table 2), cited for evidentiary purposes only; that the cannabinoid can be tetrahydrocannabinol (page 20, lines 1-5), which is known in the art to have an octanol-water partition coefficient above 100 as evidenced by Huestis (page 4, last paragraph), cited for evidentiary purposes only; and the cannabinoid is dissolved in a solvate, wherein the solvate can be propylene glycol (page 9, lines 8-17), which is known in the art to be completely soluble (miscible) in water as evidenced by AGC Chemicals (page 1, Features), cited for evidentiary purposes only. Brunn further teaches that the master granule has a mean diameter of 10-400 µm (page 11, lines 20-21) and thus a mean radius of 5-200 µm, which converts to a radius of 0.000005-0.000200 m; using the conversion formula known in the art of particle size radius to SA/V Ratio SA/V = 3/r as evidenced by Laroui et al (page G373, right column, second paragraph), cited for evidentiary purposes only, the converted SA/V Ratio for the master granules taught by Brunn is 600,000-15,000 per m.
Brunn does not expressly disclose that the concentration by mass of the solvent in the liquid phase is greater than the concentration by mass of any other ingredient in the liquid phase.
It would have been prima facie obvious to one of ordinary skill in the art to formulate the liquid phase of Brunn in such a manner that the solvent is present at a greater concentration by mass than any other individual component of the liquid phase. Brunn expressly teaches dissolving the cannabinoid, such as THC, in a solvent, such as propylene glycol, to product a coating solution. One of ordinary skill in the art would have recognized that the solvent functions as a liquid carrier in which the cannabinoid is dissolved, and would have selected an amount sufficient to dissolve the active ingredient while maintaining the coating solution taught by Brunn. The routine selection of relative proportions of solvent to dissolved solute represents a routine step in formulation development, and would have predictably resulted in the solvent being present at a greater concentration by mass than any other ingredient of the liquid phase because the solvent serves as the liquid carrier while the cannabinoid functions as the dissolved solute.
“[T]he rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395.
Regarding claims 47-48, Brunn renders obvious the composition of claims 1-3, 7, 24, 26, 28, 31, 50 and 83 as described in the above rejection.
Brunn further teaches the cannabinoids, including THC, can be present in an amount of 0.1-400 mg (page 19, lines 14-15).
It would have been prima facie obvious to one of ordinary skill in the art to utilize the amount of THC taught by Brunn as a starting point for optimizing the amount of THC, and thus concentration of THC in the liquid phase, utilized in the formulation because dosage and treatment regimen are result-effective variables, i.e. a variable that achieves a recognized result. Therefore, the determination of the optimum or workable dosages would have been well within the practice of routine experimentation by the skilled artisan. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed dosage range, the determination of the optimum or workable dosing regimen given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Taken together, all of this would result in the composition of instant claims 1-3, 7, 24, 26, 28, 31, 47-48, 50 and 83 with a reasonable expectation of success.
Conclusion
Claims 1-3, 7, 24, 26, 28, 31, 47-48, 50 and 83 are rejected.
No claim is allowed.
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/C.L.J./Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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