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 1-11 are pending in the present application file.
Priority
The following continuity data is acknowledged in the present application file:
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117
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Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 17/426442, filed on July 28, 2021.
Information Disclosure Statement
The Information Disclosure Statement(s) filed 01/15/2025 has been acknowledged by the Examiner. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the Examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 9 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 recites the limitation "the extract" in line 2 of instant claim 9. There is insufficient antecedent basis for this limitation in the claim. Instant claim 1, from which claim 9 depends, does not recite a limitation of “the extract”
Applicant may amend claim 9 to depend upon claim 6, to overcome this rejection.
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 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0231923 A1 (Guy et al.; Publication Date: August 17, 2017; henceforth Guy), in view of Numis (Numis, Adam L., et al. "Lack of response to quinidine in KCNT 1‐related neonatal epilepsy." Epilepsia 59.10 (2018): 1889-1898), and Dilena (Dilena, Robertino, et al. "Early Treatment with Quinidine in 2 Patients with Epilepsy of Infancy with Migrating Focal Seizures (EIMFS) Due to Gain-of-Function KCNT1 Mutations: Functional Studies, Clinical Responses, and Critical Issues for Personalized Therapy: R. Dilena et al." Neurotherapeutics 15.4 (2018): 1112-1126.).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Guy discloses a method of treating seizures associated with Aicardi syndrome, a type of treatment-resistant childhood epilepsy, comprising administering cannabidiol (CBD) to a subject (see paragraphs 34-46). Guy discloses children who undergo frequent seizures in childhood are often left with neurological damage which can cause cognitive, behavioral and motor delays (see paragraphs 7; see instant claim 2). Guy teaches where Aicardi Syndrome is caused by genetic malformation and further teaches where childhood epilepsy in general can be caused by many genetic mutations (see paragraphs 9 and 15).
Guy discloses where the highly purified cannabis extract comprises preferably more the 98% CBD (see paragraphs 2, 38, and 62-63; see instant claim 6). Guy discloses in Table 5 where the composition of the CBD extract product comprises other cannabinoids including 1.0% (w/w) CBDV, 0.5% (w/w) CBD-C4 and 0.15% (w/w) THC (see paragraphs 62-68; see instant claims 7-9). Guy discloses wherein the CBD of the composition may also be present as a synthetic compound (see paragraphs 2, 39 and 50-52; see instant claim 10).
Guy discloses where an example of a highly purified cannabis extract comprising CBD led to a reduction in seizure frequency in patients with treatment resistant epilepsy (TRE) that did not respond well to existing antiepileptic drugs (AED) (see Example 1, paragraphs 97-108). Guy discloses where 14 subjects were treated at a dose of 5/mg/kg/day in addition to their baseline AED regimen (see instant claims 4-5 and 11). Patients showed significant reduction in convulsive seizures, focal seizures with impairment and infantile spasm.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
Guy does not teach a method of treating epilepsy associated with KCNT1 mutation. Guy also does not teach where the epilepsy is Epilepsy of Infancy with Migrating Focal Seizures (EIMFS).
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Numis discloses where patients having EIMFS with onset in the neonatal period, pathogenic variants in the KCNT1 gene, and lack of response to AEDs, received pharmaceutical-grade CBD as part of the course of treatment. See the end of Table 1 on page 1894 for AEDs administered to Case 1 and Case 2.
Dilena discloses clinical, genetic, and in vitro preclinical data on 2 patients with KCNT1-related EIMFS, focusing on some of the critical issues of personalized therapy with quinidine (see page 1125, right column, lines 7-10). Dilena discloses where one of the EIMFS patients received 15 mg/kg/day cannabidiol (see page 1117, left column, lines 2-3).
It would have been prima facie obvious to one of ordinary skill in the art to substitute the CBD extract of Guy in the method of treating epilepsy associated with a KCNT1 mutation. Numis and Dilena teach the administration of CBD to patients having EIMFS associated with a KCNT1 mutation. The prior art teaches examples of highly purified CBD extracts reducing seizure frequency in patients with treatment resistant epilepsy (TRE) that did not respond well to existing antiepileptic drugs (AED), providing a reasonable expectation of success. Guy further discloses where subjects saw a reduction in the amount of focal seizures with impairment as well as infantile spasms (seizures). Guy teaches where Aicardi syndrome and childhood epilepsy can be caused by genetic mutations, further providing motivation for the use of CBD for the treatment of epilepsy associated with mutation.
Therefore, the present claims are prima facie obvious.
Conclusion
Claims 1-11 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUINCY A MCKOY whose telephone number is (703)756-4598. The examiner can normally be reached Monday - Thursday 8:00 - 6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/QUINCY A. MCKOY/
Patent Examiner, Art Unit 1626
/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626
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