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 09/11/2023 (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/EP2021/069782, filed July 15, 2021, which claims priority to, and the benefit of, United Kingdom Patent Application No. 2011120.9, 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) in view of Caraballo et al. (Seizure, Bailliere Tindall, London GB, Vol 80, 6 June 2020, pages 75-80, referenced in instant IDS) , Sulak et al. (Epilepsy and Behavior, Acedemic press, Vol.70, 2017, pages 328-333, referenced in instant IDS) Gedde, (Marijuana for Medical professionals conference, 2014, pages 1-45, referenced in instant IDS).
Instant claims are drawn to a method of treating seizures associated with Cortical Dysplasia and Cortical Brain Malformation, wherein the seizures associated with Cortical Dysplasia and Cortical Brain Malformation are atonic, tonic, and focal without impairment seizures comprising administering a cannabidiol (CBD) preparation.
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 or the seizures are selected from the group consisting of convulsive, focal, absence, tonic-clonic, tonic, clonic, myoclonic, atonic and reflex (page 3, lines 12-18). The type of seizure syndrome include congenital malformations such as hemimeganeencephaly or resmussen’s encephalitis (page 10, lines 8-10). They disclose cortex epilepsy which are focal (page 12, lines 16-23). 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).
Arnold et al. while it discloses cortex epilepsy does not specifically disclose the utility of CBD in treating seizures associated with cortical dysplasia.
However, Caraballo et al. discloses CBD as effective adjuvant to anti-epileptic therapy in the treatment of drug- resistant epileptic encephalopathies in children, wherein in 3 children with focal cortical dysplasia seizures were reduced by 75-90%, wherein the CBD was administered as cannabis oil (Rideau®) containing more than 95% CBD with a CBD:THC ratio of 27:1 which corresponds to a concentration of approx. 3.5% THC and wherein a CBD dose of 2 mg/kg/day twice daily or 5 mg/kg/day to a maximum dose of 25 mg/kg/day was administered (abstract, page 76, Paragraph 2, tables 1,3).
Sulak et al. discloses the beneficial effects of artisanal, hemp-based CBD or other CBD preparations in the treatment of medically intractable seizures with different etiologies including multiregional cortical dysplasia in the Washington Cohort. Patients recall placed seizure reduction from 20% up to 40%. There did not seem to be a particular seizure type that was altered by CBD (Abstract page 329, paragraph 3.1).
Gedde describes a retrospective study on a cohort of pediatric epileptic patients diagnosed with epilepsy of multiple etiologies including cortical dysplasia. The study showed that the administration of high ratio CBD:THC preparations and low ratio CBD:THC preparations resulted in reduction of seizures. Moreover, the patients reduced other antiepileptic drugs, in particular clobazam, clonazepam, levetiracem,
valproic acid and zonisamide. The document specifies that no difference in outcome among etiologies was observed (pages 1,26,27,30,35,36 and 39)
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 the references above. An ordinarily skilled artisan would be motivated from the teachings of Arnold et al. to treat seizures with CBD which is atonic, focal , Caraballo et al., Sulak et al. , Gedde and Crippa et al. provide motivation to utilize Cannabidiol in the treatment of seizures associated with cortical dysplasia. . As such a person of ordinary skill in the art would consider the use of CBD in the treatment of different types of seizures, including atonic seizures, tonic seizures and focal seizures without impairment in patients with cortical dysplasia with a reasonable expectation of success, The is further confirmed by Sulak et al. who teaches the beneficial effects of CBD in the treatment o medically untraceable seizures with different etiologies, including cortical dysplasia and further teaches that there is no particular seizure type which was not altered by CBD. As such a person of ordinary skill in the art would be imbued with a reasonable expectation of success in treating seizures associated with cortical dysplasia with CBD compound, absence of evidence to the contrary.
Conclusion
Claims 1-13 are rejected. No claims are allowed
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/SAVITHA M RAO/ Primary Examiner, Art Unit 1691