DETAILED ACTION
This office action is in response to applicant’s filing dated July 8, 2025.
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 Claims
Claims 32-51 are pending in the instant application. Acknowledgement is made of Applicant's remarks and amendments filed July 8, 2025. Acknowledgement is made of Applicant's amendment of claim 42. Claims 1-31 were previously canceled.
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to a compound represented by the structure of Formula (I) in the reply filed on July 8, 2025 is acknowledged.
Claims 43-51 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 8, 2025.
Applicant’s election without traverse of Formula (III) (compound 1, EPM310):
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and a formulation of no additional components as the formulation species in the reply filed on July 8, 2025 is acknowledged.
EPM310 is construed as a compound of Formula (I) wherein R1 is C1 alkyl and R2 is a linear C5 alkyl.
Claims 35, 38, 41 and 42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 8, 2025.
Claims 32-34, 36, 37, 39, and 40 are presently under examination as they relate to the elected species:
EPM310
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Priority
The present application is a 371 of US Application No. PCT/IL2021/050663 filed on June 3, 2021, which claims benefit of US Provisional Application No. 63/033,851 filed on June, 3, 2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on January 17, 2023 and July 8, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 103
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 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 32-34, 36, 37, 39, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Travis (US 2003/0158191 A1, cited in the IDS filed January 17, 2023).
Travis teaches cannabinol derivatives (title); in on aspect, the invention provides a method for treating a disease associated with immune dysfunction; in accordance with the method, a pharmacologically acceptable composition including at least one compound including cannabigerol derivatives [0012]; the inventive method is particularly effective in combating HIV disease [0013]. Moreover, Travis teaches a compound within the pharmacologically acceptable composition can be cannabigerol or a derivative thereof having a Formula (II) [0084]:
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Cannabigerol has the structure:
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Travis does not explicitly teach cannabigerol derivative compound of Formula (II) is the elected compound EPM310.
However, Travis teaches compounds of Formula (II) wherein R1 includes O-C1-5 alkyl (preferably OCH3) [0086-0091]; R2 includes C1 carboxy [0100] or -OCOCH3 [0097]; R3 includes a C5 alkyl [0111]; R5 includes O-CH3 [0117]; R6 includes C1 alkyl [0122]; and R7 includes C1 alkyl [0133]. It would have been prima facie obvious to one of ordinary skill in the art to select from the variables taught by Travis to arrive at the elected compound with a reasonable expectation of success. The skilled artisan would have been motivated to select from the variables disclosed to arrive at additional compounds having the similar properties and functional activity.
Taken together, all this would result in the compound and compositions of claims 32-34, 36, 37, 39, and 40 with a reasonable expectation of success.
Conclusion
Claims 32-34, 36, 37, 39, and 40 are rejected.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAYNA B RODRIGUEZ whose telephone number is (571)272-7088. The examiner can normally be reached 8am-5:00pm, Monday - Thursday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Rayna Rodriguez/ Primary Examiner, Art Unit 1628