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 the Claims
The Office Action is in response to the application filed August 28, 2023. Amended claims 1-14 are being examined on the merits herein.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of US 11,207,292 in view of Arnold (WO 2019/071302) of record. Although the claims at issue are not identical, they are not patentably distinct from each other. The instant claims are drawn to a method for treating seizures associated with a BRAF mutation comprising administering a cannabidiol (CBD) preparation. The patented claims are drawn to CBD containing pharmaceutical compositions embraced by the instant invention and methods of treating epilepsy employing said compositions. The patented claims do not specifically teach the patient population is associated with a CLCN4 mutation.
Guy does not teach the patient population is associated with a CLCN4 mutation.
Arnold teaches CLCN4 as a genetic marker indicative of a risk of seizure (page 15, lines 4-10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have employed compositions containing CBD for the treatment of epilepsy as taught by Guy and employed said treatments on patient populations with a CLCN4 mutation. The motivation, provided by Arnold, teaches CLCN4 as a genetic marker indicative of a risk of seizure. Thus, the skilled artisan would have found it obvious to treat seizures with CBD comprising compositions to patients possessing a CLCN4 mutation since this patient population is known to be at a risk of seizures.
Thus, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time it was made.
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of US 11,207,292 in view of Arnold (WO 2019/071302) of record. Although the claims at issue are not identical, they are not patentably distinct from each other. The instant claims are drawn to a method for treating seizures associated with a BRAF mutation comprising administering a cannabidiol (CBD) preparation. The patented claims are drawn to pharmaceutical compositions embraced by the instant invention and methods of treating epilepsy employing said compositions. The patented claims do not specifically teach the patient population is associated with a CLCN4 mutation.
Guy does not teach the patient population is associated with a CLCN4 mutation.
Arnold teaches CLCN4 as a genetic marker indicative of a risk of seizure (page 15, lines 4-10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have employed compositions containing CBD for the treatment of epilepsy as taught by Guy and employed said treatments on patient populations with a CLCN4 mutation. The motivation, provided by Arnold, teaches CLCN4 as a genetic marker indicative of a risk of seizure. Thus, the skilled artisan would have found it obvious to treat seizures with CBD comprising compositions to patients possessing a CLCN4 mutation since this patient population is known to be at a risk of seizures.
Thus, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time it was made.
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 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.
Claims 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Guy (GB 2531282) of record in view of Arnold (WO 2019/071302) of record.
Guy teaches cannabidiol (CBD) for use in the treatment of epilepsy, wherein the epilepsy is treatment-resistant epilepsy (TRE), and wherein the epilepsy to be treated is characterized by atonic seizures, is provided (abstract).
Guy teaches the main symptom of epilepsy is repeated seizures [0010].
Guy teaches the CBD is preferably for use in combination with one or more concomitant anti-epileptic drugs (AED), in particular clobazam, levetiracetam, topiramate, stiripentol, phenobarbital, lacosamide, valproic acid, zonisamide, perampanel and fosphenytoin, wherein the dose of the anti-epileptic drug/s that is/are used in combination with CBD is reduced (abstract; [0035]; claim 8).
Guy teaches the CBD is present as a highly purified extract of cannabis which comprises at least 98% (w/w) CBD. Preferably the extract further comprises up to 1% CBDV (cannabidivarin) and less than 0.15% THC (tetrahydrocannabinol) (abstract; claims 1-7).
Guy teaches the dose of CBD is from 5mg/kg/day to 25mg/kg/day (abstract; [0037]; claim 11).
Guy teaches the phytocannabinoids can be isolated from plants to produce a highly purified extract or can be reproduced synthetically ([0003]; [0042]).
Guy teaches generalized seizures involve the whole brain and can also be subdivided into types: Absence (petit mal) Seizures; Myoclonic Seizures; Clonic Seizures; Tonic Seizures; Tonic Clonic (grand mal) seizures; and Atonic Seizures [0012].
Regarding the limitation of claim 4, wherein there is less than or equal to 2% (w/w) of other cannabinoids comprising the cannabinoids tetrahydrocannabinol (THC); cannabidiol-C1 (CBD-C1); cannabidivarin (CBDV); and cannabidiol-C4 (CBD-C4), and wherein the THC is present as a mixture of trans-THC and cis-THC. “Less than” can be interpreted as zero THC present in the mixture as trans-THC and cis-THC, thereby meeting the limitations of the instant claim.
Guy teaches the dose of CBD is from 5mg/kg/day to 25mg/kg/day.
Guy does not teach the patient population is associated with a CLCN4 mutation.
Arnold teaches CLCN4 as a genetic marker indicative of a risk of seizure (page 15, lines 4-10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have employed compositions containing CBD for the treatment of epilepsy as taught by Guy and employed said treatments on patient populations with a CLCN4 mutation. The motivation, provided by Arnold, teaches CLCN4 as a genetic marker indicative of a risk of seizure. Thus, the skilled artisan would have found it obvious to treat seizures with CBD comprising compositions to patients possessing a CLCN4 mutation since this patient population is known to be at a risk of seizures.
Regarding the specific percentages of CBD and other cannabinoid present in the composition is considered, generally, mere optimization. Such optimization of ranges will not support the, patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "When the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimal or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also In re Peterson, 315 F. 3d at 1330, 65 USPQ 2d at 1382 "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." MPEP 2114.04.
Thus, based on the foregoing reasons, the instant claims are deemed unpatentable over the cited reference.
Conclusion
Claims 1-14 are not allowed.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAHAR JAVANMARD whose telephone number is (571)270-3280. The examiner can normally be reached on Monday-Friday, 9:00-5:00 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Alstrum-Acevedo can be reached on (571) 272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/SAHAR JAVANMARD/Primary Examiner, Art Unit 1627