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 .
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.
Election/Restrictions
Applicant’s election in the reply filed on 09/25/2025, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant elected complaint species of anti-epileptic drug:
Clobazam
Examiner found prior art of applicant elected species. Therefore, Markush search was not extended to other species of anti-epileptic drug.
Claims 1-2 and 4-12 are examined in this office action.
Current Status of 18/044,941
This Office Action is in response to the amended claims of 09/25/2025.
Claims 1 and 11 are currently amended; and claims 2, 4-10 and 12 are previously presented.
Claims 1-2 and 4-12 are examined in this office action.
Priority
Effective filing date is 09/10/2020.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) were submitted on 05/16/2023, 09/17/2024 and 09/25/2025. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 1-2 and 4-12 are rejected under 35 U.S.C. 103 as being unpatentable over:
Whalley et. al (WO 2013/045891),
In view of
WILKHU (WO 2019/135075),
In further view of
Frost et. al (Electroencephalography and clinical Neurophysiology 106 (1998) 79-83),
and in further view of:
Anisel (Anisel, et.al. “PHARMACEUTICAL DOSAGE FORMS AND DRUG DELIVERY SYSTEMS” 7th edition, 1999).
1. Determining the scope and contents of the prior art.
Whalley et.al. teaches a composition of cannabidivarin (CBDV) and tetrahydrocannabinol (THC) (Page example 3) reduces seizure (examiner interpret this to include focal motor seizures with impairment, focal non-motor seizures with impairment, generalized motor seizures, generalized non-motor seizures, unknown onset motor seizures, and non-motor seizures, using BRI) mortality (paragraph [00148]) partially teaching claims 1. Walley further teaches composition of CBDV comprises of other cannabinoids tetrahydrocannabinol (THC); tetrahydrocannabivarin (THCV); cannabidiol-C 1 (CBD-Cl); cannabidiol (CBD); cannabidivarin acid (CBDVA) and cannabidiol-C4 (CBD-C4) (tables 3.1 and 3.2) partially teaching claim 1-2, 4 and 10-11).
Wilkhu et.al. teaches composition of CBDV to treat Rett Syndrome (reference claim 34) (partially teaching claim 1 and 11-12). Wilkhu further teaches CBDV is synthetic or from natural source (examiner interpret this as plants) (reference claim 18) teaching claims 7-10.
Frost et.al. teaches use of anti-epileptic drugs, valproic acid, phenobarbital, phenytoin, ethosuximide, vigabatrin, felbamate, clobazam (applicant’s elected species) and clonazepam, for treating Rett syndrome (page 80, result section) thus partially teaching claims 5-6.
Anisel et.al. teaches dosages of pharmaceuticals and frequency of the dosage are routinely optimized based on body weight and body surface area (Anisel et.al. page 50).
2. Ascertaining the differences between the prior art and the claims at issue.
Whalley et.al. does not teach method of treating seizure associated with Rett syndrome with anti-epileptic drugs in combination with CBDV. Whalley further does not teach the concentration or the dosage of CBDV.
Wilkhu et.al. does not teach method of treating seizure associated with Rett syndrome with anti-epileptic drugs in combination with CBDV. Wilkhu further does not teach the concentration or the dosage of CBDV.
Frost et.al. does not teach method of treating seizure associated Rett syndrome with anti-epileptic drugs in combination with CBDV. Frost et.al. further does not teach the concentration or the dosage of CBDV.
Anisel et.al. does not teach the dosage of CBDV.
3. Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill is an artisan who have sufficient background in developing treatment for seizure related to Rett syndrome.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
A person skilled in the art would be motivated to use CBDV composition for treating seizure (examiner interpret this to include focal motor seizures with impairment, focal non-motor seizures with impairment, generalized motor seizures, generalized non-motor seizures, unknown onset motor seizures, and non-motor seizures, using BRI) mortality (Whalley et.al. paragraph [00148]) and the composition of CBDV and THC (Whalley et. al. tables 3.1 and 3.2) to treat seizure associated with Rett syndrome. Since seizure associated with Rett syndrome can be treated with CBDV from the prior art of Wilkhu et. al. (Wilkhu et. al. reference claim 34), it would be expected combining CBDV and THC composition (Whalley et. al. tables 3.1 and 3.2) would be able to treat seizure associated with Rett syndrome. Thus, teaching claims 1-2, 4, and 7-12.
Furthermore, a person skilled in the art would be motivated to use anti-epileptic drug clobazam (applicant’s elected species) for treating seizure associated with Rett syndrome (Frost et.al. page 80, result section) with the combined teaching of Wilkhu et. al. and Whalley et. al. (see above). The combination of anti-epileptic drug clobazam with CBDV and THC composition is expected to treat seizures associated with Rett syndrome because combination of anti-epileptic drug clobazam with CBDV and THC to be same or more effective than individual composition. Thus, teaching claims 1-2 and 4-12.
Claims 1,4 and 11-12 are directed to dosage and concentration of the composition of CBDV and THC. Examiner interprets these attributes as variables the artisan would normally be expected to routinely optimize. For example, dosages of pharmaceuticals and frequency of the dosage are routinely optimized based on body weight and body surface area (Anisel et.al. page 50). Generally, dosage will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such attributes are critical. The specification does not indicate the dosage and frequency of the dosage to be critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05(II)(A).
Applicants are asked to provide evidence of secondary considerations, such as surprising/unexpected results, that encompass the full scope of independent claims 1 in order to mitigate the chance that future obviousness rejections can be made.
Conclusion
No Claims are allowable as written.
US. Patent no. 11,207,292 is not a double patenting reference are because reference claims are drawn to preparation of composition of instant claims. But the reference claims not drawn to method of treating seizures associated with Rett syndrome.
Co-pending application no. 18/546,254 is not a double patenting reference because reference claims are drawn to preparation of composition of instant claims. But the reference claims not drawn to method of treating seizures associated with Rett syndrome.
Co-pending application no. 17/770,436 is a not double patenting reference because reference claims are drawn to preparation of composition of the instant claims. But the reference claims are not drawn to method of treating seizures associated with Rett syndrome.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rehana Ismail whose telephone number is (703)756-4776. The examiner can normally be reached Monday-Friday 9:00am-5:00pm.
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/R.I./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625