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 .
Applicant should note that the instant application has been reassigned to a new examiner in Art Unit 1617.
Election/Restrictions
Applicant’s election of Group III in the reply filed on 03/05/2026 is acknowledged. Because applicant did not distinctly and specifically point out any errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-13 and 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/05/2026.
Claims 14-16 are under current examination.
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 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (CN110179862A; publication date: 08/30/2019; citing the English machine translation) in view of Jones (US 20060112584; publication date: 06/01/2006).
With regard to claim 14, Liu discloses a method of forming a cannabidiol (a cannabinoid) inclusion compound with cyclodextrin (abstract) comprising a step of dissolving the cannabidiol in ethanol, dissolving cyclodextrin in water, and adding the ethanol/cannabidiol solution to the aqueous solution of cyclodextrin (page 1) after which an inclusion complex (i.e. cannabinoid-cyclodextrin complex) is formed. This product is then dried.
Liu does not disclose that the complex is dried by refractance window dryer.
Jones teaches that refractance window drying is a newer dehydration technology (0003) that produces a dehydrated product with a density similar to that obtained by spray-drying, but with a retention in heat-labile constituents similar to that obtained via freeze-drying (0010).
It would have been prima facie obvious dry the cannabinoid-cyclodextrin complex disclosed by Liu by refractance window drying. The artisan of ordinary skill would have been motivated to do so in order to reduce thermal degradation of the product and would have had reasonable expectation of success because this would merely require following the method described by Jones.
With regard to claim 15, Liu discloses that the cyclodextrins may be gamma-cyclodextrin, alpha cyclodextrin, beta-cyclodextrin, or hydroxypropyl-beta-cyclodextrin (page 2).
With regard to claim 16, the complex may be formulated (i.e. mixed with) into oral agents, injection, solid gum wafer, tablet, suppository, can be used for any dosage form of food addition, all of which contain excipients.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE PEEBLES whose telephone number is (571)272-6247. The examiner can normally be reached Monday through Friday: 9 am to 3 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE PEEBLES/Primary Examiner, Art Unit 1617