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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/28/2023 and 04/03/2025 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claims 1, 5 and 10 objected to because of the following informalities:
Claim 1 recites “the pharmaceutically acceptable salt thereof” which should recite “a pharmaceutically acceptable salt thereof”
Claims 5 and 10 recite "alky" which should recite "alkyl".
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 1-3, 5-6, 8, 10-12 and 15-21 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.
The recitation “A is a residue of an amino acid” is unclear. The specification at Para. [0042] indicates that the entirety of
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is the amino acid residue whereas the claims refer to A itself as a residue of an amino acid. It is therefore unclear whether A refers to an entire residue of an amino acid encompassing the connecting moieties or whether A only refers to the side chain and alpha carbon or other connecting groups. Dependent claims referring to A as specific amino acids and not residues thereof further render the claims unclear. Dependent claims which do not rectify indefiniteness are included in this rejection.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2-3 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 2 and 3 recite “wherein A is alanine …” and “wherein A is valine”, respectively, whereas claim 1 recites “A is a residue of an amino acid”. Amino acids and their residues are distinct from each other, and the language of claims 2-3 refers to free amino acids which are not encompassed by the residue of claim 1. Applicant may cancel the claims, amend them to place them in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims comply with the statutory requirements.
The broadest reasonable interpretation given to claim 1 is wherein
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is a residue of an amino acid, including non-canonical amino acids (any compound with an amino and carboxylic acid group which would have been incorporated into the corresponding NH and CO moieties, respectively, of the above residue). Claims 2-3 are interpreted that A of the amino acid residue corresponds to the alpha carbon of the amino acid and the corresponding side chain. An amendment to easily overcome the rejection while both avoiding new matter and retaining the broadest reasonable interpretation given is not readily apparent and therefore none has been suggested. Applicant is invited to contact the Examiner to discuss any proposed amendments to overcome the rejection.
Allowable Subject Matter
Claims 1-6 and 8-21 are considered to be free of the prior art. The closest prior art is WO 2022/213200 A1 which teaches O-substituted cannabichromene derivatives as prodrugs (formula (1d), Para. [0011]). The exemplary compounds CBCp1 and CBCp3 are taught at Para. [0046]. The instantly claimed compounds differ in that they require substitution with an amino acid residue and further substitution with CN-R-COOH. There is no teaching nor suggestion in the prior art to derivatize cannabichromene with such a group.
Claims 4, 9 and 13-14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Claims 1-3, 5-6, 8 are rejected.
Claims 4, 9 and 13-14 are objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JED A KUCHARCZK whose telephone number is (571)270-5206. The examiner can normally be reached Mon-Fri 7:30 to 5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JED A KUCHARCZK/Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
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