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 .
DETAILED ACTION
Claims 1-13 are pending and are under consideration in the instant office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/21/2023 (2) 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 as to the merits. See attached copy of the PTO-1449.
Priority
This application is a U.S. National Phase application, filed under 35 U.S.C. § 371(c), of International Application No. PCT/EP2021/069834, filed July 15, 2021, which claims priority to, and the benefit of, United Kingdom Patent Application No. 2011127.4, filed July 20, 2020
Claim Rejections - 35 USC § 103
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-13 are rejected under 35 U.S.C. 103(a) as being unpatentable over by Arnold et al. (WO 2019/071302) and Farfel et al. (US 2019/247333) and Porter et al (Epilepsy and Behaviour, Volume 29, no 3, 201, pages 574-577) further in view of Guy et al. (WO 2019/207319) (all references are cited in Instant IDS 11/21/2023)
Instant claims are drawn to a method of treating seizures associated with PCDH19 mutation comprising administering a cannabidiol (CBD) preparation, wherein the CBD preparation comprises greater than 95% (w/w) CBD and not more than 0.15% (w/w) tetrahydrocannabinol (THC).
Arnold et al discloses the utility of cannabigerolic acid (CBGA) in the treatment of seizures including tonic-clonic seizures alone or in combination with other cannabinoids such as cannabidiol (abstract). They disclose that the seizures may be associated with epileptic syndrome selected from a group consisting of idiopathic epilepsy, Dravet syndrome, Lennox-Gastaut syndrome, epilepsy characterized by infantile spasms, febrile seizures, childhood absence seizures and other forms of phrmocoresistant epilepsy (page 3, lines 12-16). They further disclose the individual requiring treatment is determined to have a gene mutation, Interr alia the PCDH19 mutation (page 15, lines 11-15). They disclose that their CBGA may be derived rom the purified extract of cannabis (plant based) (page 2, lines 5-17) . They disclose their extract to contain less than 1% w/w of tetrahydrocannabinol (THC) and/or tetrahydrocannabinol acid (THCA) (page 22, lines 27-30). They disclose where in the cannabinoid is synthetically produced (page 23, lines 5-8). They further disclose that the CBGA can be administered in conjunction with another anticonvulsant drug which is another cannabinoid such as Cannabidiol (CBD) (page 25, lines 20-24). They also disclose that CBGA can be used concomitantly with one or more of other anticonvulsant drugs such as aceazolamid, carbamazepine, clonazepam, gabapentin, topiramate, phenytoin etc. (page 25, lines 5-19, claim 9)
Farfel et al. discloses a method of reducing convulsive frequence in a human patient diagnosed with Dravet syndrome, comprising administering to the patient fenfluramine and cannabidiol [0053, 0168, 0250]. They further disclose that PCDH19 genes have been linked to Dravet syndrome [0057].
Porter et al. discloses a study where children with Dravet syndrome, were treated with cannabidiol enriched cannabis, which resulted in reduced seizures, better mood, increased alertness, better sleep and decreased self-stimulation, They also disclose in Table 1, section 3, that a patient diagnosed with EFMR, also known as PCDH19 gene related epilepsy, had a seizure frequence reduction of Circa 80%. The administration of the CBD enriched cannabis resulted in the administration of 7mg/kg/day CBD and 0.5 mg/kg/day THC (entire document).
The references above does not specifically disclose where in the CBD preparation comprises greater than 90% w/w CBD or the dose of CBD as recited in instant claims 10-13
However, Guy teaches that cannabinoids are natural (from plant abstract) and synthetic (see 0005) wherein the preparation of the CBD is greater than 98% (see 0025) and comprises less than 2% of the other cannabinoids i.e., CBD-C1 etc (see 0026) and the CBD is administered from 0.1 mg/kg/day for example 20, 25, and 50 mg per day (see 00207-00208, as required by instant claims 11-14.
As such it would have been prima facia obvious to a person of ordinary skill in the art to arrive at the instant claims motivated and guided by the combined teachings of Arnold et al,. Farfel et al. , Proter et al. and Guy. An ordinarily skilled artisan would be motivated from Arnold et al. Farfel et al. and Porter et al. to utilize cannabidiol in the treatment of seizures associated with PCDH19 mutations as they all disclose the utility of Cannabidiol in treating these type of seizures, Guy et al discloses CBD preparations as instantly claimed and since the CBD preparations are already known in the art and the utility of CBD in treating seizures associated with PCDH19 is already known in the art, a person of ordinary skill in the art would consider using CBD preparation as defined by Guy et al. in the treatment methods taught by Arnold et al. farfel et al. and Porter et al. As such a person of ordinary skill in the art would be imbued with a reasonable expectation of success in treating all the the instantly claimed type of seizure with cannabidiol absence of evidence to the contrary.
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 AlA. 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 |.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 - 13 are provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 15-28 of U.S. Patent Application No. 17611824 in view of Farfel et al. (US 2019/0247333, already of record). Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
The claims of the instant application are drawn to treating seizure associated with PCDH19 mutations by administering CBD in the current application (claims 1- 13) and copending application is drawn to treating a patient suffering from epileptic spasm (claims 15-28) application administering CBD.
Both applications recite using the same compositions and/or derivatives thereof. The compositions recited in the claims are anticipatory of each other. Although the copending application fails to teach the mutations, the cited reference Farfel et al. teaches disclose that PCDH19 genes have been linked to Dravet syndrome, [0057] which is involved or associated with epilepsy spasm. Therefore it would have been obvious to practice the copending invention employing the instant claims with a reasonable expectation of success. Because treating epilepsy would reasonably involve a gene mutation or PCDH19.
In view of the foregoing, the copending application claims and the current application claims are obvious variations.
Claims 1 - 13 are provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 15-28 of U.S. Patent Application No. 18/006,129 in view of Farfel et al. (US 2019/0247333 already of record). Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
The claims of the instant application are drawn to treating seizure associated with PCDH19 mutations by administering CBD in the current application (claims 1- 13) copending application is drawn to treating seizure associated with cortical brain malfuncitions comprising administering a CBD preparation .
Both applications recite using the same compositions and/or derivatives thereof. The compositions recited in the claims are anticipatory of each other. It would have been obvious to one of ordinary skill in the art to have used the instant claims in practicing the copending application because Farfel et al. discloses that epilepsies include malformations of cortical development [0019]. As such the instant claims would have been obvious over the copending as the instant and the copending application both teach treating seizure in a patient with the same agents.. In view of the foregoing, the copending application claims and the current application claims are obvious variations.
. In view of the foregoing, the copending application claims and the current application claims are obvious variations.
Claims 1 - 13 are provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-14 of U.S. Patent Application No. 18005845 in view of Farfel et al. (US 2019/0247333 already of record). Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
The claims of the instant application are drawn to treating seizure associated with PCDH19 mutations by administering CBD in the current application (claims 1- 13) and copending application is drawn to treating seizure associated with GR1N2B and CACNA1 H mutations comprising administering a CBD preparation .
Both applications recite using the same compositions and/or derivatives thereof. The compositions recited in the claims are anticipatory of each other. It would have been obvious to one of ordinary skill in the art to have used the instant claims in practicing the copending application because Farfel et al. discloses that mutations in CACNA1H gene similar to PCDH19 gene mutations are linked to conditions characterized by seizure types including generalized seizures, myoclonic seizures, absence seizures and febrile seizures [0058]. As such the instant claims would have been obvious over the copending as the instant and the copending application both teach treating seizure in a patient with the same agents.. In view of the foregoing, the copending application claims and the current application claims are obvious variations.
Claims 1 - 13 are provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-147 of U.S. Patent Application No. 18/005,843.
Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
The claims of the instant application are drawn to treating seizure associated with PCDH19 mutations by administering CBD in the current application (claims 1- 13) and copending claims are drawn to method of treating seizures associated with gross chromosomal mutations comprising administering a CBD preparation..
Both applications recite using the same compositions and/or derivatives thereof. The compositions recited in the claims are anticipatory of each other. The instant claims of treating PCDH19 mutation is a specie of the gross chromosomal mutations claimed in copending application and therefore are obvious variants of each other.
Claims 1 - 13 are provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 13 and 19-33 of U.S. Patent Application No. 18005848 in view of Farfel et al. (US 20190247333 already of record) . Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
The claims of the instant application are drawn to treating seizure associated with PCDH19 mutations by administering CBD in the current application (claims 1- 13) and copending application is drawn to treating seizure associated with SNYGAP1 mutations comprising administering a CBD preparation (claims 1 -14)
. It would have been obvious to one of ordinary skill in the art to have used the instant claims in practicing the copending application because Farfel et al. discloses that mutations in SYNGAP1 gene similar to PCDH19 gene mutations are linked to conditions characterized by seizure types including generalized seizures, myoclonic seizures, absence seizures and febrile seizures [0058]. As such the instant claims would have been obvious over the copending as the instant and the copending application both teach treating seizure in a patient with the same agents.. In view of the foregoing, the copending application claims and the current application claims are obvious variations.
Claims 1 - 13 are provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over the claims of U.S. Patent Application No’s 18005851; 18225853, 18005868, 18005960, 18225961: 18006121, 18006125, 18006127, 18006129, 18006131; 18006133, 18256307 and 18548003
Although the conflicting claims are not identical, they are not patentably distinct from each other. The referenced teaching in administering the same compounds to the same treatment recipient group, with varying mutations or varying subgroup administering the same compound referenced would make obvious the instant invention.
In looking in continuity data, it is noted that applicant has numerous pending applications encompassing the same or similar subject matter of the instant application. Applicant should review all subject matter considered the same or similar, and submit the appropriate Terminal Disclaimer(s
Conclusion
Claims 1-13 are rejected. No claims are allowed
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/SAVITHA M RAO/ Primary Examiner, Art Unit 1691