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
The present application claims foreign priority of PCT/GB2022/051200 filed 05/11/2022 which claims priority of GB 2106786.3 filed 05/12/2021.
Election/Restriction
Applicant’s election of Groups 1, 2, and 3, claims 1-4, 11, 13, and 15-19 without traverse in the reply filed on 05/29/2026 is acknowledged and entered onto the record.
Status of the claims
The claims filed on 05/29/2026, election of groups 1-3 accordingly with the response filed on 05/29/2026 are entered onto the record, claims 1-4, 11, 13-19 are pending. Claims 11 and 15 are withdrawn according to Applicant’s filed amended claims. Examiner notes that claim 11 is directed towards an elected Group but has been withdrawn by Applicant. Claim 13 is also withdrawn as it depends from claim 11. Claims 1-4, 14, and 16-19 are currently examined.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/29/2024 complies with the
provisions of 37 CFR 1.97, 1.98, and MPEP § 609. Accordingly, it has been placed in the application file
and the information therein has been considered on the merits.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 47 of copending Application No. 18/560,341 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. Appln. No.: ‘341 claims Formula V, where R1 is H, R2 and R3 are H, and X1 is Br (see ‘341 claim 47) which reads on instant claims 1, 2, and 14.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 1, 2, 14, 16, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Makriyannis et al., (US 2012/0172339 A1, published Jul. 5, 2012) and in view of Guy et al., (GB2591567A, published 04.08.2021)..
Regarding claim 1, Makriyannis teach resorcinol derivatives of Formula I and pharmaceutical compositions comprising those compounds (see para. [0012]-[0013]). Specifically, Makriyannis teach a compound of Formula I, wherein the resorcinol moiety has R1 and R2 are H, R3 is Br, (see para. [0014], [0016]) and Y is the structure of I 1, wherein R7 and R8 are -OH (see para. [0019], and Table 4, compound 1).
While Makriyannis teach cannabinoid compound resorcinol derivatives, the compounds disclosed therein differ from the instantly claimed compound in that it does not include the -OH group on the substituted cyclohexane.
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In the same field of endeavor of cannabinoid and cannabidiol-like compounds with resorcinol moieties as thereapetuics, Guy et al., teach the cannabidiol (CBD)-type cannabinoid, 6-hydroxy cannabidiol (6-OH-CBD) (see para. [0002]), and its use as medicaments for treating epilepsy (see para. [0034], Example 2; shown below).
6-OH-CBD is one of many known metabolites and analogues of cannabidiol (see para. [0019]-[0020]. 6-OH-CBD differs from the instantly claimed compound by having a 5-carbon alkyl chain on the resorcinol moiety instead of a bromine.
Since Guy teach that 6-hyrdoxy-cannabidiols are used to treat epilepsy, one of skill in the art at the time of filing of the instant application would find it obvious to combine the compound of Makriyannis with the Br substituted resorcinol moiety and the 6-hyrdoxy-cannabidiol of Guy and retain anti-convulsant activities of the compound with a reasonable expectation of success. See MPEP §2143 (I)(E).
Thus claim 1 is obvious in view of Makriyannis and Guy.
Regarding claim 2, which depends from claim 1, the recited limitation of “wherein the compound is (l 'R,2'R,4'S)-4-bromo-5'-methyl-2'-(prop- l-en-2-yl)- l ',2' ,3' ,4'-tetrahydro-[ 1, l '-biphenyl]-2,4' ,6-triol” only further limits the compound of claim 1 to one of two instantly disclosed isomers (see specification, pg, 11, scheme 1) of the compound of claim 1. MPEP§2144.09 (II) states “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In reWilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In reMay, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978)”.
Therefore, claim 2 is obvious in view of Makriyannis and Guy.
Regarding claim 14, which is directed to a process for the production a compound of claim 1, Guy et al., discloses methods of producing 6-hydroxy cannabidiol (see pg. 5, Example 1), which, as discussed above, is structurally similar to the compound of instant claim 1 – namely in that they both contain a substituted cyclohexane and resorcinol moiety and differing only in the alkyl side chain. The reaction methods disclosed by Guy et al, have similar reaction reagents and yield similar intermediates (see pg. 7, reaction scheme; shown below), for example, the use of acetic anhydride and the intermediate indicated by the red arrow below that is similar to the intermediate of the instant disclosure as seen in para. [0036].
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It would have been obvious to a person having ordinary skill in the art before the effective of the claimed invention to apply the methods of Guy et al. used to produce structurally and functionally analogous compounds (i.e., compounds of instant claim 1). Applying a known process to a structurally analogous compound taught by the prior art represents the use of a known technique to improve similar products in the same way, where the results would be predictable to one of skill in the art (see MPEP§ 2143(I)(C).
Therefore, claim 14 is obvious in view of Makriyannis and Guy.
Claims 3-4 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Makriyannis et al., (US 2012/0172339 A1, published Jul. 5, 2012) and Guy et al., (GB2591567A, published 04.08.2021),as applied to claim 1 discussed above, and in further view of Whalley et al. (US 9125859 B2, published 09.08.2015; see IDS filed 05/31/2024).
Regarding claims 3-4, Guy et al., also teach “compositions for use as a medicament comprising 6-hydroxy cannabidiol (6-OH-CBD), and one or more pharmaceutically acceptable excipients” (see para. [0033]). However, Guy et al. does not provide any further teachings on the preparation of the pharmaceutical compositions disclosed therein. In the same field of endeavor of cannabinoid-like compounds (i.e., cannabidivarin) for use in the treatment of epilepsy, Whalley et al., teach pharmaceutical formulations suitable for oral delivery (e.g., capsules and tablets) (see Col. 8, lines 39-42).
Regarding claims 17-18, while Guy et al. does teach the use of the compositions disclosed therein for the treatment of epilepsy there is no disclosure as to seizures. However, Whalley et al. teach the cannabinoid compositions disclosed therein can be used to treat epileptic seizures (see Col. 8, lines 55-57) and preferably “generalized or a temporal lobe seizure (see Col. 9, lines 4-5).
As discussed above, since the instantly claimed compounds are similar in structure to the 6-OH-CBD and other cannabinoid-like compounds - namely by the substituted cyclohexane and resorcinol moiety it would be prima facie obvious to one of skill in the art at the time of filing of the instant application to prepare pharmaceutical compositions comprising a compound of instant claim 1 as capsules and tablets for oral delivery and to apply them for the treatment of epilepsy and epileptic seizures (e.g., generalized seizures) based on the teachings of Whalley et al. See MPEP §2143 (I)(D) and (E).
Thus, claims 3-4 and 17-18 are obvious over Makriyannis and Guy, and in further view of Whalley et al.
Conclusion
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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