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 .
Status of the Claims
Claims 1-6, 9, 11, 12, and 14-23 are pending. Acknowledgment is made of the amendment of claims 1 and 6, the cancellation of claims 7, 8, 10, and 13, and the addition of new claims 21-23, in the reply filed 12/11/2025.
Withdrawn Rejections
Applicant’s amendment to the claims, filed 12/11/2025, overcomes the rejection of claims 1, 7, and 8 on the ground of nonstatutory double patenting over U.S. Patent No. PP34802 P2. The rejection of claims 1, 7, and 8 has been withdrawn.
Applicant’s amendment to the claims, filed 12/11/2025, overcomes the rejection of claims 1, 2, 5-7, 9, 10, and 17-20 under 35 U.S.C. 101 as being directed to a product of nature. The rejection of claims 1, 2, 5-7, 9, 10, and 17-20 has been withdrawn.
Applicant’s amendment to the claims, filed 12/11/2025, overcomes the rejection of claims 1, 3-6, 9-11, and 13-16 under 35 U.S.C. 102(a)(1) as being anticipated by Faraci et al. (US 20200037638 A1). The rejection of claims 1, 3-6, 9-11, and 13-16 has been withdrawn.
Applicant’s amendment to the claims, filed 12/11/2025, overcomes the rejection of claims 2, 7, 8, 12, and 17-20 under 35 U.S.C. 103 as being unpatentable over Faraci et al. (US 20200037638 A1) further in view of Schatz (US PP34802 P2). The rejection of claims 2, 7, 8, 12, and 17-20 has been withdrawn.
New Rejections
Necessitated by Claim Amendment
Claim Rejections - 35 USC § 103
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, 3-6, 9, 12, and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Wendschuh et al. (US 20160250270 A1), and further in view of Chistov (US 12,029,722 B2) with an effective filing date of 06 May 2019.
Wendschuh et al. teaches, in paragraph [0009], compositions comprising new combinations of purified cannabinoids in combination with purified terpenes. Examples 5-7 teach specific formulations comprising THC (37.5-62.5 wt%), CBD (12.5 wt%), CBG (12.5 wt%), b-Mycrene (.0125-.03125 wt%), and limonene (.0125 wt%), as in instant claims 9, 12, and 14-16.
Wendschuh et al. fails to teach the dosage form comprising a plasticizer, bulking agent, diluent, and synthetic excipient.
However, Chistov teaches, in claim 1, an orally administered drug delivery film, comprising: a polymer of about 20% to about 50%; a plasticizer of about 6% to about 9%; a defoamer of about 0.2% to about 0.5%; an antioxidant of about 0% to about 3%; a β-cyclodextrin; and a cannabinoid, as in instant claims 1 and 3-6. Chistov teaches, in claim 28, that the composition comprises one or more of polyethylene glycol, hydroxypropylmethylcellulose and polyvinylpyrrolidone, which could act as a bulking agent and synthetic excipient, glycerol as the plasticizing agent, and sucrose as taste masking agent. Applicant defines the diluent and bulking agent, in paragraph [0097], as including sucrose. The terpenes and cannabinoids used in this composition are taught in claims 17 and 18 to include myrcene, limonene, carophyllene, linalool, Δ-9 THC, Δ-9 CBD, cannabigerol, cannabidigerolic acid, cannabichromene, and others.
It would be obvious to use the active ingredients taught in the composition by Wendschuh et al. in the dosage form taught by Chistov that includes the plasticizer, bulking agent, diluent, and synthetic excipient, because it is taught by Chistov that this method of delivery using dosage delivery films “have proven particularly effective for a class of patients with phagophobia, a fear of swallowing, pnigophobia, a fear of choking, and dysphagia, difficulty swallowing.” Therefore, one would be motivated to use this dosage delivery film in order to treat patients who have difficulty swallowing or a fear of swallowing.
One would have a reasonable expectation of success in using the composition taught by Wendschuh et al. in the dosage film taught by Chistov because the active ingredients in both compositions are taught to include cannabinoids and terpenes, with the only difference being the formulation of the delivery method.
Claims 2, 11, and 17-23 are objected to as being dependent upon a rejected claim.
Advisory Notice
Claims 2, 11, and 17-23 appear allowable if written in independent form.
Conclusion
Claims 1, 3-6, 9, 12, and 14-16 are rejected.
Claims 2, 11, and 17-23 are objected to.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RILLA M SAMSELL whose telephone number is (703)756-5841. The examiner can normally be reached Monday-Friday, 7-3.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.M.S./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624