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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/17/2026 has been entered.
Status of the Claims
Per Applicant’s amendment to the claims, submitted on 05/18/2026, claims 1, 14, and 21 are amended, and claims 5, 7-9, 11-13, and 18 are canceled. Currently, claims 1-4, 6, 10, 14-17, and 19-21 are pending in the instant application. Claims 17 and 21 are hereby rejoined. Claims 1-4, 6, 10, 14-17, and 19-21 are pending examination.
Claim Rejections - 35 USC § 112 Se – New Grounds of Rejection
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 21 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 21 is indefinite for reciting “further comprising: e) at least one pharmaceutically acceptable excipient” (underlined for emphasis), because a person of ordinary skill in the art would not reasonably be able to understand the metes and bounds of the claim. Parent claim 19 recites a composition consisting of : a) Synthetic CBD, b) BCP, c) a mixture of C8 and C10 triglycerides, and d) alpha tocopherol. The instant claim provides improper antecedence by attempting to broaden the scope of the parent claim.
Claim Rejections - 35 USC § 103 – Withdrawn
Rejections of claims 1-4, 6, 14-16, and 19-20:
Applicant’s arguments are persuasive. Accordingly, the rejections are hereby withdrawn. The teachings of Friedman are now considered as the closest prior art. While Friedman teaches a compositions comprising pure (i.e., 99.9%) CBD, caryophyllene, emulsifiers, and oily carriers, they do not appear to teach the use of a mixture of C8 and C10 triglycerides having the recited 1:1-1:3 triglyceride ratio.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4, 6, 10, 14-17, and 19-21 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-7, 10-12, 14, 16-18, and 20-22 of copending Application No. 18/265,509 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims at hand contain overlapping subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 of the instant application recites a composition comprising:
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Claim 14 of the instant application recites a method of stabilizing synthetic cannabidiol in an oral composition, the method comprising mixing synthetic CBD having a purity of at least 98.5% with a lipophilic solvent and alpha tocopherol, the solvent consisting of BCP and a mixture of C8 and C10 triglycerides, wherein:
The volume ratio of the BCP to the mixture of C8 to C10 triglycerides is from about 1:1 to about 1:3
The alpha tocopherol is present in an amount from about 0.5% w/w to about 1.5% w/w
Claim 1 of the copending application recites a composition comprising:
CBD in a concentration from about 1% w/w to about 35% w/w
A lipophilic solvent in a concentration from about 60% w/v to about 98.9% w/v wherein the lipophilic solvent comprises ß-caryophyllene (BCP) and a mixture of C8 and C10 triglycerides, wherein the volume ratio of BCP to the mixture of C8 and C10 triglycerides is from about 1:1 to about 1:3; and
a-tocopherol in a concentration from about 0.1% w/v to about 5% w/v
wherein the CBD is a purified botanical isolate that is at least 98 wt.% pure, and wherein the composition is substantially free of tetrahydrocannabinol (THC), other cannabinoids, other terpenes, other solvents, essential oils, surfactants, emulsifiers, alcohols, and other pharmaceutically active ingredients.
Claim 20 of the copending application recites a method of stabilizing botanically sourced CBD in an oral composition containing same, the method comprising dissolving botanically sourced CBD having a purity of at least 98 wt.% in a lipophilic solvent consisting of BCP and a mixture of C8 and C10 triglycerides, adding and mixing in α-tocopherol (vitamin E), wherein:
the volume ratio of the BCP to the mixture of C8 and C10 triglycerides is from about 1:1 to about 1:3
the α-tocopherol is present in an amount from about 0.5 % w/v to about 1.5% w/v.
The claims of the instant application and copending application are essentially drawn to the same subject matter. Namely compositions comprising CBD and a lipophilic solvent, wherein the lipophilic solvent further comprises BCP and a mixture of C8 and C10 triglycerides, and further wherein the CBD is substantially pure and does not contain extraneous cannabinoids. The most significant difference between the claims of the instant application and the claims of the copending application is that the CBD of the instant application is recited to be synthetic, whereas the copending application recites CBD as a botanical isolate. While each application recites a different source for the CBD, it remains that they are reciting presence of the same compound without chemical differentiation. The scope and subject matter of the instant application and the copending application are significantly overlapping, and accordingly cannot be considered as patentably distinct.
Conclusion
Claims 1-4, 6, 10, 14-17, and 19-21 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC TRAN whose telephone number is (571)272-7854. The examiner can normally be reached Mon-Fri 8:00-5:00.
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/ERIC TRAN/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
