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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/17/2026 has been entered.
Response to Amendment
The amendments received 02/17/2026 have been entered. Claims 37, 39, 41, 43, 51-53, and 55-60 are pending. Any objections or rejections previously set forth in the Office Action mailed 09/16/2025 not maintained herein have been overcome and are withdrawn.
The declaration under 37 CFR 1.132 filed 02/17/2026 (hereafter “the Tam declaration”) is sufficient to overcome the rejection of claims 37, 39, 41, 43, 45, 47-53, and 55-56 based upon the rejection under 35 U.S.C. 103. Examiner has considered the evidence and arguments set forth in the Tam declaration and finds them persuasive, in that Applicant has established the lack of predictability in translating in silico and in vitro efficacy of PPAR agonists to in vivo models of non-alcoholic fatty liver disease (NAFLD). One of ordinary skill in the art would not, in view of the state of the art, have a reasonable expectation of success in combining cannabidiol and cannabigerol for the treatment of NAFLD. The rejection under 35 U.S.C. 103 is withdrawn.
Information Disclosure Statement
The Information Disclosure Statement filed on 02/17/2026 is in compliance with the provisions of 37 CFR 1.97 and has been considered in full. A signed copy of list of references cited from the IDS is included with this Office Action.
Claim Objections
Claims 51-53 and 55 are objected to because of the following informalities:
Claim 51: “each to the exclusion of any other cannabinoid” is redundant as the claim later recites “wherein the method excludes administration of any other cannabinoid”;
Claim 52: “for reversing accumulation of fat in hepatocyte cells” is redundant as the claim later recites “wherein said administering step reverses accumulation of fat in hepatocyte cells”, Examiner suggests amending the claim to recite “The method according to claim 51, wherein said administering step induces an anti-steatotic effect in the subject”;
Claim 53: “for reversing accumulation of fat in hepatocyte cells” is redundant as the claim later recites “wherein said administering step reverses accumulation of fat in hepatocyte cells”, Examiner suggests amending the claim to recite “The method according to claim 51, wherein said administering step reverses accumulation of fat in hepatocyte cells in the subject”;
Claim 55: “for reducing fat mass or increasing lean mass” is redundant as the claim later recites “wherein said administering step reduces fat mass or increases lean mass in the subject”, Examiner suggests amending the claim to recite “The method according to claim 51, wherein said administering step reduces fat mass or increases lean mass in the subject”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claims 41, 43, 51, and 56 are 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 41 recites “the ratio between CBD and CBG”. This limitation lacks antecedent basis. Examiner suggests amending “wherein the ratio between CBD and CBG is between 0.1:1 and 1:0.1, CBD : CBG” in claim 41 to recite “wherein the CBD and CBG are administered at a ratio between 0.1:1 and 1:0.1, CBD : CBG”. Claim 43 is rejected for requiring the limitation at issue but “the ratio is 1:1” does not require amendment if Applicant adopts the suggested amendment to claim 41.
Claim 51 recites “each to the exclusion of any other cannabinoid”. It is unclear what this limitation means (can CBD increase effectiveness of CBG, but not vice-versa?) and could be interpreted as contradictory.
Claim 56 recites “wherein CBG is administered as a sole active ingredient”. This limitation causes confusion as claim 37, from which claim 56 depends, requires that CBG and CBD be administered as a combination. It is unclear if the limitation at issue means that CBG is administered alone, or if CBG is administered with CBD but CBD is not administered in a therapeutic amount/in an amount sufficient to be an active ingredient.
Allowable Subject Matter
Claims 37 and 39 are allowed. Claims 57-60 are objected to as being dependent upon a rejected base claim.
Conclusion
Claims 37 and 39 are allowed. Claims 52-53, 55, and 57-60 are objected to. Claims 41, 43, 51, and 56 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MADELINE E BRAUN whose telephone number is (703)756-4533. The examiner can normally be reached M-F 8:30am-5:00pm ET.
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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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/M.E.B./Examiner, Art Unit 1624 04/23/2026
/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624
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