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 claims
Pending claims 1-14 have been examined on the merits.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office
action.
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 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Shimojima et al. Hum Genome Var. 2018 Mar 29;5:18007 in view of Guy et al. (WO2019207319) and in further view of Rudzinski et al. J of Investigative Med, vol. 64, no. 6, Aug. 2016, pp. 1087–101.
Regarding claims 1-2, Shimojima (abstract; page 3) teaches “Approximately 50% of patients with PURA-related neurodevelopmental disorders exhibited epilepsy regardless of whether they harbor a 5q31.3 deletion or PURA mutation. Patients with the 5q31.3 deletion or a PURA mutation should be carefully monitored for epileptic seizures.” This suggests that seizure phenotypes do not differ fundamentally from common epilepsies, encompassing a range of focal and generalized seizures such as myoclonic, generalized tonic-clonic, and epileptic spasms. As evidence by Reijnders (page 5) indicates that patients with PURA-related disorders commonly present with seizure types including, but not limited to generalized tonic-clonic seizures and tonic seizures. This clinical similarity infers that a person of ordinary skill in the art (POSITA) would recognize that seizure in PURA mutation patients can be managed using conventional seizure treatment. (Reijnders et al. PMID: 28448108). Shimojima, however, does not teach cannabidiol (CBD).
However, Guy (page 37, [00196] bridged page 38) teaches the use of CBD for treating seizure disorders such as epilepsy. Therefore, it would have been obvious to a POSITA to modify Guy’s teachings in view of Shimojima’s disclosure to include patients with PURA mutations in the scope of treating seizures with CBD preparations, to arrive at the claimed invention. This is because seizures in patients with PURA mutations present no different clinically than typical seizures seeing in other epilepsy disorders.
Regarding claims 3-4, and as applied to claims 1-2, Guy (page 4, [0025])
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Regarding THC, Guy (page 28, [00157]), and as applied to claims 1-2, teaches
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Regarding claims 5-6, the combined teachings of Shimojima and Guy does not teach anti-epileptic drugs (AED).
However, Rudzinski (page 1087 and 1088), and as applied to claims 1-2, teaches the use of EAD, such as levetiracetam, clobazam, and rufinamide to treat seizure, particularly generalized tonic–clonic seizures, as an example. Therefore, it would have been obvious to a POSITA to modify Guy’s teachings in view of Rudzinski and Shimojima’s disclosure to arrive at the claimed invention. This is because, seizures in patients with PURA mutations present no different clinically than typical seizures seeing in other epilepsy disorders; and that the combined teachings of Rudzinski and Guy teach the use of CBD and AED to treat seizures.
Regarding claim 7-8, Guy (page 6, [0036] and [0037]), and as applied to claims 1-2, teaches
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Regarding claim 9-10, Guy (page 7, [0050] and [0051]), and as applied to claims 1-2, teaches
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Regarding claim 11-14, Guy (page 41, [00207] bridged page 42 [00208]), and as applied to claims 1-2, teaches that CBD preparation or a pharmaceutical composition comprising the same is administered as one or more doses to provide about 5 mg/kg/day of CBD; about 20 mg/kg/day of CBD; about 25 mg/kg/day of CBD and about 50 mg/kg/day of CBD.
Claim Objections
Claim 6 recites list of substituents with the phrase “and” instead of “or” to indicate alternative options. However, using the phrase “and” in such a list implies that all substituents must be present together, which may not reflect the intended purpose. Therefore, for clarity and proper interpretation, Applicant is required to correct the claims by replacing “and” with the phrase “or”.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PIERRE PAUL ELENISTE whose telephone number is (571)270-0589. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JAMES H ALSTRUM-ACEVEDO can be reached at (571) 272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.P.E./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622