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 .
Election/Restrictions
Applicant’s election without traverse of species 1, as drawn to a compound of formula I, in the reply filed on 5/28/2026 is acknowledged.
Claims 1-12, 19-24 and 70-72 are currently pending.
Claims 7-12, 19-24 and 71-72 are withdrawn from consideration as being drawn to non-elected species.
Claims 1-6 and 70 are currently pending and under consideration.
Information Disclosure Statement
The information disclosure statement filed on 5/30/2024 is acknowledged and has been considered except where lined through. It is noted that in order to comply with 37 CFR 1.98(a)(2), a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed.
Claim Objections
Claims 1-2, 4 and 6 are objected to because of the following informalities:
Regarding claims 1-2 and 4, claims 1-2 and 4 recite the phrase “amino acid sugar”. While the specification utilizes the phrase “amino sugar” and provides examples of amino sugars such as in claim 4, a review of the specification does not appear to define what this phrase encompasses. It is suggested that Applicants amend the claims to recite an amino sugar.
Claim 4 is further objected to because it contains an “and” between sialic acid and Daunosamine which should not be there and does not contain an “and” or an “or” separating the two last amino augars.
Regarding claim 6, claim 6 recites that the aminosulfonic acid derivative comprises -CONHCH2CH2SO3H. However, when considering the aminosulfonic acid derivative is R4 which is attached to a carbonyl, it is unclear of whether the “CO” in the formula described in claim 6 is necessary. For example, a review of the specification identifies the following compound
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which contains the aminosulfonic acid derivative. As such, it would appear that the correct formula for the derivative (e.g. R4) is -NHCH2CH2SO3H, wherein the “CO” is already present in already present in (R1 and/or R2). .
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 2 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 2 recites the limitation "amino acid –(R5)" or aminosulfonic acid derivative-(R5). However, there is insufficient antecedent basis for this limitation in the claim, since claim 1, from which claim 2 depends, does not provide support for the amino acid or aminosulfonic acid derivative to be substituted with R5. Since R5 encompasses H, the amino acid-R5 will be interpreted as an amino acid, e.g. an OH, for prior art purposes.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3 and 70 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shandong Luye Pharmaceuticals (WO2022/213931A1, 2022-10-13, Google Patent Translation provided) referred to herein as Shandong.
Shandong teach cannabidiol prodrugs and pharmaceutical compositions comprising said prodrug (Abstract). In particular, Shandong teach a prodrug having the structure
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which reads on the instant claims wherein R1 is glycine, R2 is H and R3 is a linear alkane (See claim 8).
Conclusion
Claim 5 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.
The closest prior art to claim 5 is considered to be to Moustafa (WO2021/155474A1, 2021-08-12) whom teaches cannabinoid sulfate esters, their soluble salts and stable formulations thereof (abstract). The prior art differs from the instant invention in that the sulfonate is produced via an ether linkage vs. the carbonyl as presently claimed and the prior art does not teach or suggest such substitution.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
-Arifian et al. (Molecules 2022; 27: 7631),
-US20190382814A1, and
-WO2021243467A1.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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BRANDON J. FETTEROLF, PHD
Primary Patent Examiner
Art Unit 1626
/BRANDON J FETTEROLF/Primary Examiner, Art Unit 1626
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