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 .
Status of Application
Receipt of the Preliminary Amendment dated October 14, 2025 is acknowledged.
Claims 1-14 and 16-24 are pending in this application.
Claims 1 and 12-14 have been amended.
Claim 15 is cancelled.
Claims 16-24 are new.
All pending claims are under examination in this application.
Information Disclosure Statement
Receipt of the Information Disclosure Statement filed on October 16, 2025 is acknowledged. A signed copy is attached to this office action.
Withdrawn Objections/Rejections
Claim Objections
The objection to claim 1 because the claim recites the acronym CBD for cannabidiol has been withdrawn in view of the amendment to the claim to recite “cannabidiol (CBD)”.
Claim Rejections - 35 USC § 102
The rejection of claims 1-2 and 7-14 under 35 U.S.C. 102(a)(1) as being anticipated by Gu et al. (Cannabidiol attenuates seizures and EEG abnormalities in Angelman syndrome model mice, The Journal of Clinical Investigation, Vol 129, Number 12, December 2019), as evidenced by Rotaru et al. (Angelman Syndrome: From mouse models to therapy, Neuroscience Review, 45 (2020) 172-189) has been withdrawn in view of the amendment to claim 1 to recite a 15q11.2 microdeletion.
Claim Rejections - 35 USC § 103
The rejection of claims 1-4 and 7-14 under 35 U.S.C. 103 as being unpatentable over Gu et al. (Cannabidiol attenuates seizures and EEG abnormalities in Angelman syndrome model mice, The Journal of Clinical Investigation, Vol 129, Number 12, December 2019), as evidenced by Rotaru et al. (Angelman Syndrome: From mouse models to therapy, Neuroscience Review, 45 (2020) 172-189) in view of Guy et al. (WO 2019/207319) has been withdrawn in view of the amendment to claim 1 to recite a 15q11.2 microdeletion.
The rejection claims 1-2 and 5-14 under 35 U.S.C. 103 as being unpatentable over Gu et al. (Cannabidiol attenuates seizures and EEG abnormalities in Angelman syndrome model mice, The Journal of Clinical Investigation, Vol 129, Number 12, December 2019), as evidenced by Rotaru et al. (Angelman Syndrome: From mouse models to therapy, Neuroscience Review, 45 (2020) 172-189) in view of Shaaya et al. (Seizure treatment in Angelman syndrome: A case series from the Angelman Syndrome Clinic at Massachusetts General Hospital, Epilepsy and Behavior, 60(2016)138-141) has been withdrawn in view of the amendment to claim 1 to recite a 15q11.2 microdeletion.
Newly Applied Rejections
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 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 1-8, 11-14, and 16-24 are rejected under 35 U.S.C. 103 as being unpatentable over JP 2017519758 (hereinafter referred to as JP’758) in view of Szaflarski et al. (Higher cannabidiol plasma levels are associated with better seizure response following treatment with a pharmaceutical grade cannabidiol, Epilepsy and Behavior 95 (2019) 131-136).
JP’758 discloses the use of cannabidiol (CBD) in the treatment of absence seizures, specifically in the Lennox-Gastaut syndrome, tuberous sclerosis complex, Drave syndrome, Douce syndrome, CDKL5, Dup15q, Jebons syndrome, myoclonic absence epilepsy, neuronal ceroid lipofuscinosis (NCL) and brain abnormalities (abstract).
Regarding claim 2, as noted above, absence seizures are disclosed.
Regarding claims 3-4, the CBD used is in the form of a high purity extract of cannabis such that the CBD is present in more than 98% (w / w) of the total extract and the other constituents of the extract are characterized. Specifically, the cannabinoid tetrahydrocannabinol (THC) has been substantially removed to levels below 0.15% (w / w), and the propyl analog of CBD, cannabinivalin (CBDV) are present in an amount of up to 1% (technical field).
Regarding claim 5, JP’758 discloses the use of CBD in combination with one or more antiepileptic drugs (AED) (abstract).
Regarding claim 6, All patients in the study were taking at least one combination AED. These AEDs include clobazam, clonazepam, chlorazepic acid, desmethylclobazam, diazepam, ethosuximide, ferbamate, gabapentin, ketogenic diet, lacosamide, lamotrigine, levetiracetam, lorazepam, midazolam, N-desmethylclobazam pentozentol, pendantazole , Topiramate, trazodone, vagus nerve stimulation, valproic acid, vigabatrin, and zonisamideRegarding claims 7-8, CBD was obtained from cannabis sativa L. plant (Materials and Methods).
Regarding claims 11-14 and 16, dosing schedules start at 5 mg/kg/day and are increased by increments of 2-5 mg/kg until tolerability occurred or until the maximum dose reached 25 mg/kg/day (Materials and Method).
While JP’758 discloses CBD for the treatment of epilepsy characterized by absence seizures in addition to other general and/or focal seizures, JP’758 does not disclose the seizures are caused by one of the gross chromosomal mutation recited in claim 1 or newly presented claims 18-24.
Szaflarski discloses seizure control with the use of a cannabidiol (CBD) (abstract).
The study of Szaflarski discloses they found evidence of a linear correlation between CBD dosage and plasma levels, and that higher dose/levels are associated with a higher response rate for seizure improvement (conclusion).
Regarding claim 17, Szaflarski showed a positive correlation between CBD dosage ranges of 5-50 mg/kg/day (results).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have tried administration of CBD to patients with the chromosomal mutations recited in the instant claims since it is widely disclosed to be a useful treatment for a variety of other chromosomal mutations and the treatment of seizures in general. The skilled artisan would have a reasonable expectation of success with the knowledge that CBD is known to treat seizures in generalized epilepsy, as well as in numerous chromosomal mutations.
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over JP 2017519758 (hereinafter referred to as JP’758) in view of Szaflarski et al. (Higher cannabidiol plasma levels are associated with better seizure response following treatment with a pharmaceutical grade cannabidiol, Epilepsy and Behavior 95 (2019) 131-136) as applied to claims 1-8, 11-14, and 16-24 above, and further in view of Vistasol Medical Group (Synthetic CBD may be a safe treatment for seizures, June 3, 2019).
The teachings of JP’758 and Szaflarski are discussed above.
The combination does not disclose the CBD is synthetic.
Vistasol discloses a nonintoxicating form of cannabidiol that chemists can make from inexpensive non-cannabis ingredients can treat seizures just as effectively as herbal cannabidiol.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have used a synthetic version of CBD in the formulations of JP’758 and Szaflarski since Vistasol discloses it to be just as effective as natural CBD.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA S MERCIER whose telephone number is (571)272-9039. The examiner can normally be reached M-F 6:30 am to 4 pm EST.
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/MELISSA S MERCIER/Primary Examiner, Art Unit 1615