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 .
Priority
This application claims priority of PCT/GB2022/051199 filed 05/11/2022.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on 03/20/2026 and 10/03/2024 comply with the provisions of 37 CFR 1.97, 1.98, and MPEP § 609. Accordingly, they have been placed in the application file and the information therein has been considered on the merits.
Status of the claims
4. The claims 24, 26-28, 40-46, 49-50 are pending. Claims 40-46, 49-50 are withdrawn. Claims 24 and 26-28 are currently examined. Examiner notes that Applicant’s response to the Restriction Requirement stated that claim 36 is pending, however claim 36 was previously cancelled.
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.
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Claim 24 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hampson et al., (US6630507B1 published October 07, 2003, see PTO-892). Hampson et al. discloses cannabinoids and related pharmaceutical compositions for the treatment of neurological disorders (e.g., as an anti- epileptic) (see Col. 17, lines 7-11). Specifically, Hampson et al., teach compound the cannabinoid (see Col 5, Line 45) where R19 is a carboxyl group, and R26 is an alkyl group, and R20 is a hydrogen. More specifically, Hampson teach the compounds 44 and 56 which are a cannabinoid and the cannabinoid with a carboxyl group (“CBD-7-oic acid”) (see Example 11, shown below).
Therefore, the compounds of Hampson et al., read on the compound of Formula (II) of instant claim 24.
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.
Claim 24 and 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al., "Overview of Cannabidiol (CBD) and Its Analogues: Structures, Biological Activities, and Neuroprotective Mechanisms in Epilepsy and Alzheimer's Disease," European Journal of Medicinal Chemistry, 112163, Vol. 192, pp. 1-14 (Feb 2020) (see IDS filed 03/20/2026) and in view of Hampson et al., (US6630507B1 published October 07, 2003, see PTO-892).
Regarding claim 24, Li et al. teach analogues of CBD, including the (-)-CBD terpene moiety-modified analogue compound 15 (i.e., (-)-CBD-7-oic acid) (see pg. 5 Section 3.2.1., para. 1, Table 3, Fig. 6; shown below) which is a homolog (i.e., by addition of a -CH2- group in the alkyl chain, as shown by red arrow below) of the compound of formula (II) of instant claim 24.
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MPEP 2144.09 II states “homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. See In reWilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977)”
Therefore, one of skill in the art
Regarding claims 26-28, Hampson et al. discloses a cannabidiol was prepared as a solution and administered via intra-peritoneal injection (ip) in a 90% saline:5% emulphor 620 (emulsifier):5%ethanol vehicle” (see Example 7, Col. 16, lines 31-34).
Hampson et al., further teach methods of treatment for the invention disclosed therein (see Example 9, Col. 19), wherein the “vehicle in which the drug is delivered can include… common carriers, such as sterile saline or glucose solution” (see Col 19, lines 60-61). Additionally, Hampson et al., disclose that “the compounds may also be administered as inhalants, for example in pharmaceutical aerosols utilizing solutions, suspensions, emulsions, powders, and semisolid preparations” (see Col. 20, lines 10-15). Furthermore, Hampson et al. teach that “The compositions are preferably in the form of a unit dose in Solid, Semi-Solid and liquid dosage forms Such as tablets, pills, powders, liquid Solutions or Suspensions, injectable and infusible Solutions, for example a unit dose Vial, or a metered dose inhaler. Effective oral human dosage ranges for cannabidiol are contemplated to vary from about 1-40 mg/kg, for example 5–20 mg/kg, and in particular a dose of about 20 mg/kg of body weight” (see Col. 20, lines 25-33).
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing of the instant application to prepare the compound (e.g., 7-OH-CBD) as a pharmaceutical composition that read on instant claim 24 and 26-28.
Conclusion
Claims 24 and 26-28 are rejected. No claims are allowed in this action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALAN JEROME FOWLER whose telephone number is (571)272-0195. The examiner can normally be reached Monday - Friday 9-5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALAN J FOWLER/ Examiner, Art Unit 1691
/RENEE CLAYTOR/ Supervisory Patent Examiner, Art Unit 1691
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