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
The office acknowledges Applicants filling of the claim amendments on 8/9/2024. Claims 1-11, 13-17, 20-23 are pending and are examined based on the merits herein.
Application Priority
This application filed on 07/26/2023 is a National Stage entry of PCT/IB2022/ 050781, International Filing Date: 01/28/2022, PCT/IB2022/050781 Claims Priority from Provisional Application 63142835, filed 01/28/2021.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed on 8/9/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the Examiner.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 4, 23 are rejected under 35 U.S.C. 102(A)(1) as being anticipated by Guy et al. (US 20100035978).
Guy’s teaching anticipate claim 1, by teaching a method of treating sleep disturbance caused by peripheral neuropathic pain in a human patient comprising administering to a patient in need thereof a therapeutically effective amount of a combination of a combination of cannabinoids cannabidiol (CBD) and delta-9-tetrahydrocannabinol (THC), wherein the ratio of CBD:THC by weight is between 10:1 and 1:10 (See claim 28).
Guy anticipates claim 4 by teaching the maximum daily dosage dose of each cannabinoid is less than or equal to 120 mg of CBD (See claim 37).
Guy anticipates claim 23 because administration of the same agent, herein in same set of subjects with sleep disturbances will result in the same pharmacological effects of circadian rhythm is maintained or improved.
Claims 1, 3-11, 14, 23 are rejected under 35 U.S.C. 102(A)(2) as being anticipated by Sebree et al. (CA 3151171A1)
Claims 1, 3, 14 are anticipated by Sebree’s teaching of the method of treating behavioral problems and seizures in a subject having developmental and epileptic encephalopathy (DEE) by transdermally administering an effective amount of cannabidiol (CBD) gel, ZYN-002 to the subjects wherein behavioral problems are treated in the subject; the treatment includes a meaningful decrease in sleep disturbance as determined by an improvement of the Sleep (See Abstract, claims 1, 3, Table 5, [0058], [0080]).
Claims 4-7 are anticipated by Sebree’s teaching of administration of cannabidiol to subjects as a single daily dose or two daily doses (See claims 12-13) in an effective amount of 250, 500, 750, 1000 mg, (See claim 11), total dose of 500 mg CB (250 mg/sachet, administered twice daily) (See [0059]).As to the dose in claim 5, if
Sabree anticipates claims 8-9 by teaching improved sleep by administration of cannabidiol in subjects with sleep disturbances (Table 5).
Sabree anticipates claims 10-11 by teaching that CBD Is purified or synthetic CBD (See claims 14-16).
Sabree anticipates claim 23 because administration of the same agent, herein in same set of subjects with sleep disturbances will result in the same pharmacological effects of circadian rhythm is maintained or improved.
Claim(s) 1, 4, 23 are rejected under 35 U.S.C. 102(A)(1) as being anticipated by Levine et al. (US 20200289460).
Levine anticipates claim 1 by teaching method for treatment of a sleep disorder, the method comprising administering to a subject in need thereof a therapeutically effective amount of a composition comprising cannabidiol (CBD), 3.75 mg/kg wherein the sleep disorder is selected from the group consisting of: decreased sleep duration, prolonged sleep onset, increased number of transient awakenings during a sleep session, aberrant sleep-awake cycles, aberrant sleep architecture, parasomnia, and insomnia (claims 1, 9, 15). For e.g. increased number of awakenings or aberrant sleep awake cycle are sleep disturbances in a subject. As to claim 4, 3.75 mg/kg of CBD administered daily to an average subject weighting 70 kg would correspond to 262.5 mg which falls within the claimed range of 250-1000 mg/total daily.
Levine anticipates claim 23 because administration of the same agent, herein in same set of subjects with sleep disturbances will result in the same pharmacological effects of circadian rhythm is maintained or improved.
Claims 1, 3, 20 are rejected under 35 U.S.C. 102(A)(1) as being anticipated by Schleider (IDS: WO2019224824).
Schleider anticipates claims 1, 3, 20 by teaching treatment of autism spectrum disorders (ASD) by administering a composition comprising cannabidiol and at least one symptom treated include sleep disturbances; the composition is for transdermal administration (Abstract, claims 1-2, 5, 7, 12-13). As to the effective amount, effective amount is being administered as the method treats ASD symptoms.
Note: Skuratovich (US 20170231948) cannabinoid alcoholic drink to aid sleep.
Claim Rejections - 35 USC § 112
Claim 5 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 5 recites the limitation ‘the effective dose of CBD’ in lines 1-2. It is noted that claim 5 depends on claim 1 and claim 1 do not recite any limitation regarding to effective dose. There is insufficient antecedent basis for this limitation in the claim.
Note: For the sake of compact prosecution, claim 5 has been examined based on the interpretation that the limitation is to the effective amount is in the range of 10-25 mg/kg.
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.
Claim(s) 6-11, 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Guy et al. (US 20100035978).
Guy as discussed above and the reference is incorporated herein.
As to claims 6-7, Guy teaches daily dosage administration of the cannabinoid. It is within the skill of an artisan to administer an effective amount of cannabidiol once or twice a day depending on factors such as condition, age, other medications or other conditions being treated etc. Dosage regimen is routine and it is within the skill of an artisan.
As to claims 8-9, as to the treatment including improvement in sleep related impairment, e.g. sleep quality, administration of the same of the same agent, herein in same set of subjects with sleep disturbances will result in the same pharmacological effects including sleep quality, total sleep etc.
Guy teaches that cannabinoid, e.g. cannabidiol is substantially pure and can be synthetic (see claims 59-60) thus addressing claims 10-11.
As to claim 13, the reference teaches cannabidiol in general and that includes both the racemic forms. It is well known in the art to separate the racemic mixtures to different forms and is within the skill of an artisan to use (-) cannabidiol in the method.
Guy further teach the pharmaceutical formulation comprising the cannabinoid, cannabidiol in the form of a gel (See claim 39) thus addressing claim 14.
Claim(s) 6-11, 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Levine et al. (US 20200289460).
Levine as discussed above and the reference is incorporated herein.
As to claims 6-7, Levine teaches 75 mg/kg of CBD administered daily for treating sleeping disorder. It is within the skill of an artisan to administer an effective amount of cannabidiol once or twice a day depending on factors such as condition, age, other medications or other conditions being treated etc. Dosage regimen is routine and it is within the skill of an artisan.
As to claims 8-9, as to the treatment including improvement in sleep related impairment, e.g. sleep quality, administration of the same of the same agent CBD, herein to the same set of subjects with sleep disturbances will result in the same pharmacological effects including sleep quality, total sleep etc.
Levine teaches that cannabinoid, e.g. cannabidiol can be isolated from plant matter source or can be synthetic (see [0016]). A person skilled in the art would have found it obvious to obtain pure CBD by plant extraction or use synthetic cannabinoid in the method with a reasonable amount of success, thus addressing claims 10-11.
As to claim 13, the reference teaches cannabidiol in general and that includes both the racemic forms. It is well known in the art to separate the racemic mixtures to different forms and is within the skill of an artisan to use (-) cannabidiol in the method.
Levine further teach the pharmaceutical formulation comprising the cannabinoid, cannabidiol in the form of a gel ([0017]) thus addressing claim 14.
Claims 1, 2, 5-11, 13, 16, 23 are rejected under 35 U.S.C. 103 as being unpatentable over Macphail (WO 2020014776 A1).
As to claims 1-2, Macphail teach that an oral dispersible film strip comprising a cannabinoid (for example, cannabidiol) and melatonin can be used to treat and/or prevent sleep disorders and sleep disturbances such as sleep apnea (See p 21, lines 19-21). A person skilled in the art would have found it obvious to administer an effective amount of cannabidiol composition to the subject with sleep disturbances, e.g. sleep apnea from Macphail. A person skilled in the art would have been motivated to arrive the instantly claimed method with a reasonable amount of success and to derive therapeutic effects.
As to claim 5, the reference teaches about 20 mg/kg of cannabinoid can be delivered with the oral strip. A person skilled in the art would have found it obvious to administer for e.g. 20 mg/kg of cannabidiol to the subject with sleep apnea to derive therapeutic effects.
As to claims 6-7, It is within the skill of an artisan to administer an effective amount of cannabidiol once or twice a day depending on factors such as condition, age, other medications or other conditions being treated etc. Dosage regimen is routine and it is within the skill of an artisan.
As to claims 8-9. 23, administration of the same agent, herein in same set of subjects with sleep disturbances will result in the same pharmacological effects of sleep improvement (e.g. total sleep), circadian rhythm is maintained or improved.
As to claims 10-11, the reference teach that CBD has been purified to high purity, or synthetically produced (see p 4, last para, before Vitamin B12).
As to claim 13, the reference teaches cannabidiol in general and that includes both the racemic forms. It is well known in the art to separate the racemic mixtures to different forms and is within the skill of an artisan to use (-) cannabidiol in the method.
As to claim 16, obstructive sleep apnea(OSA) is a type of sleep apnea and a skilled artisan would have found it obvious to use cannabidiol from the reference teachings to treat OSA in subjects.
Claims 15, 20-21, are rejected under 35 U.S.C. 103 as being unpatentable over by Sebree et al. (CA 3151171A1)
Sebree teachings as discussed above. The reference and the rejections are incorporated herein.
As to claim 15, Sebree teach that the CBD is formulated as a permeation-enhanced gel (See [0012], [0042] and [0043]). Thus a skilled artisan would have found it obvious to use the permeation enhanced gel in the method as claimed.
Claims 20-21 are addressed by Sebree’s teaching of autistic spectrum disorder as one of the characteristics of SYNGAP1 (See Table 2, p 8-9) and the method of treating behavioral problems including treating sleep disturbances in subjects having epileptic encephalopathy (DEE) having SYNGAP1 encephalopathy. In other words, the subjects with SYNGAP1 with ASD characteristics have sleep disturbances and are treatable with an effective amount of cannabidiol. DEE-ASD subjects are a type of ASD subjects. A person skilled in the art would have found it obvious to administer cannabidiol in patients with ASD with a reasonable amount of success and to derive therapeutic benefits of improvement in sleep.
Note: The claims recite limitation of ASD and DEE-ASD. The specification in page 1, teach that autism spectrum disorder is ASD; developmental and epileptic encephalopathies (DEEs).
Claims 17, 22 are rejected under 35 U.S.C. 103 as being unpatentable over Macphail (WO 2020014776 A1) in view of Jehan et al. (Sleep Med Disord. 2017 ; 1(4)).
Macphail teachings discussed as above. The above rejection is incorporated herein.
Macphail do not teach that obstructive sleep apnea is associated with obesity or overweight condition of the subject or the BMI is greater than 25.
Jehan teachings are directed to obstructive sleep apnea and obesity. The reference teaches that one of the main components contributing to sleep apnea is obesity (abstract). Obesity is defined as a BMI≥ 30, whereas a BMI ≥ 25.0 indicates the person is overweight (see p 2, para 3, line 1). Jehan discusses the relationship between obesity and sleep; people who are obese (with a BMI of more than 30) with shorter sleep duration have twice (see p 2, para 4) as many subjective sleep problems compared to non-obese people
A person skilled in the art would have found it obvious to administer an effective amount of cannabidiol composition to the subject with sleep disturbances, e.g. obstructive sleep apnea from Macphail and Jehan. From Jehan it is obvious that OSA is associated with obesity and overweight (with BMI of >25). A person skilled in the art would have been motivated to administer an effective amount of cannabidiol composition to OSA subjects who are obese and overweight, with a BMI of >25 to provide quality sleep and therapeutic benefits. Thus claims 17, 22 would have been obvious from the combined prior art teachings.
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3-11, 13, 23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 11-14, 18 of co-pending Application No. 17697629 (‘629 reference application).
The instant claims are directed to:
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The dependent claims are limited to specific subjects, dose amounts, dosage regimen, treatment includes sleep-related improvement, pure or synthetic CBD being used in the method, (-)-cannabidiol, gel formulation, effects of administration.
‘629 reference claims are directed to:
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The dependent claims are limited to improvement effects, includes cognition and awareness, reduction in seizures, dosage regimen, amount (250 mg, 500 mg, 700 mg or 1000 mg), synthetic CBD, DEE is Lennox-Gastaut syndrome.
From the reference claims a skilled artisan would have found it obvious that administration of an effective amount of CBD (e.g. 250 mg, in single or two daily doses) transdermally improve sleep in subjects with DEE. This addresses claims 1, 3, 4, 6-9. As to claim 5 if for e.g. 10 mg of CBD is administered to an average subject weighing 70 kg, then 700 mg is administered and this is taught by the reference claim 11. As to claim 10, though pure CBD administration is not taught it is well known in the art that cannabinoids occur in plants and pure CBD can be extracted and used. It is within the skill of an artisan to use pure CBD in the method as claimed with a reasonable expectation of success. As to claim 13, the reference claim teaches the use of cannabidiol in general and that includes both the racemic forms. It is well known in the art to separate the racemic mixtures to different forms and is within the skill of an artisan to use (-) cannabidiol in the method. As to claims 8, 9, 23, administration of the same agent, herein in same set of subjects with sleep disturbances will result in the same pharmacological effects of sleep improvement (e.g. total sleep), circadian rhythm is maintained or improved.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3-11, 13-15, 20 and 23 are provisionally rejected on the ground of obviousness type nonstatutory double patenting as being unpatentable over claims 1, 5-6, 8-20 of co-pending Application No 18/255,816 (‘816).
The instant claims as above.
‘816 reference claims are drawn to a method of treating refractory seizures in a human subject diagnosed with autism spectrum disorder (ASD), the method comprising: administering an effective amount of cannabidiol (CBD) to the human in need thereof to treat the refractory seizures; wherein the human subject further suffers from sleep-related impairment, and wherein the treatment includes an improvement in sleep-related impairment. The dependent claims are limited to specific dosage amounts (250-1000 mg daily), administered single daily or twice daily, pure or synthetic CBD used, (-)-cannabidiol, gel formulation, permeation enhanced gel.
A person skilled in the art would have found it obvious to arrive at the claimed method from the reference claims because it teaches treating ASD patients with an effective amount of CBD (250-1000 mg daily), transdermal administration, and improve the sleep impairment, e.g. quality sleep. Further taught is dosage regimen, pure or synthetic CBD, (-) cannabidiol, permeation enhancer gel. This addresses claims 1, 3-11, 13-15, 20. As to claim 23, administration of the same agent, herein in same set of subjects with sleep disturbances will result in the same pharmacological effects of sleep improvement (e.g. total sleep), circadian rhythm is maintained or improved.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4-11, 13, 20 and 23 are provisionally rejected on the ground of obviousness type nonstatutory double patenting as being unpatentable over claims 1-16
of co-pending application 18642059 (‘059), or claims 1-20 of co-pending application 19/224,281 (‘281) or claim 1 of co-pending application 19/008,407 (‘407) or claims 1-8, 10-16 of co-pending application 17/970,395 (‘395) or claims 1-8 of US 12213951 (‘951) or claims 1-7 of US 10314792 (‘792) or claims 1-8 of US 10568848 (‘848) in view of Fleury-Teixeira et al. (Frontiers in Neurology, 2019).
The instant claims as above.
‘059 reference claims are to a method of treating irritability in a subject diagnosed with autism spectrum disorder (ASD), the method comprising: administering an effective amount of cannabidiol (CBD) to the subject, wherein the subject has a high baseline ABC-C irritability score, and wherein the subject also has a high baseline ABC- CFXS social avoidance score and/or a high baseline Parent Rated Anxiety Scale for ASD (PRAS- ASD), wherein irritability in the subject is treated. The dependent claims are limited to transdermal administration, synthetic or botanical CBD, dose amount of 250-1000 mg, in two daily doses.
‘281 reference claims are to a method of treating one or more symptoms of moderate-to-severe autism spectrum disorder in a subject, the method comprising: administering an effective amount of cannabidiol (CBD) to the subject, wherein the one or more symptoms of moderate-to-severe autism spectrum disorder are treated; wherein the CBD is administered transdermally; wherein the effective amount of CBD is a 250mg, a 500mg, or a 750 mg total daily dose; administered in two daily doses; CBD is synthetic, botanical derived or pure.
‘407 reference claim is directed to a method of treating a human suffering from an autism spectrum disorder comprising: transdermally administering a therapeutically effective amount of synthetic cannabidiol to the human suffering from the autism spectrum disorder to effectively treat the autism spectrum disorder in the human in need thereof.
‘395 reference claims are directed to a method of treating irritability in a subject diagnosed with autism spectrum disorder (ASD), the method comprising: administering an effective amount of cannabidiol (CBD) to the subject, wherein the subject has a high baseline ABC-C irritability score, and wherein the subject also has a high baseline ABC- CFXSsocial avoidance score and/or a high baseline Parent Rated Anxiety Scale for ASD (PRAS- ASD),wherein irritability in the subject is treated; wherein the CBD is administered transdermally; CBD is synthetic; effective amount of CBD is 250-1000 mg daily dose, two daily doses administration.
‘951 reference claims are directed to a method of treating a human suffering from an autism spectrum disorder comprising: transdermally administering via a gel or cream a therapeutically effective amount of purified cannabidiol to the human suffering from the autism spectrum disorder to effectively treat the autism spectrum disorder in the human in need thereof, wherein the gel or cream is administered to the upper arm; wherein the cannabidiol is (-)-cannabidiol; wherein the therapeutically effective amount of cannabidiol is 250 mg to 500 mg total daily; formulated as permeation enhancement gel, single or two daily doses; effective amount is 50-500 mg total daily.
‘792 reference claims are to a method of treating a human suffering from an autism spectrum disorder comprising: administering a therapeutically effective amount of synthetic cannabidiol to the human suffering from the autism spectrum disorder to effectively treat the autism spectrum disorder in the human in need thereof; wherein the cannabidiol is (-)-cannabidiol; formulated as permeation enhancement gel, single or two daily doses; effective amount is 50-500 mg total daily and transdermally administered.
‘848 reference claims are to a method of treating a human suffering from an autism spectrum disorder comprising: transdermally administering via a gel or cream a therapeutically effective amount of purified cannabidiol to the human suffering from the autism spectrum disorder to effectively treat the autism spectrum disorder in the human in need thereof; wherein the cannabidiol is (-)-cannabidiol; wherein the therapeutically effective amount of cannabidiol is 250 mg to 500 mg total daily; formulated as permeation enhancement gel, single or two daily doses; effective amount is 50-500 mg total daily.
The above reference claims teach a method of treating ASD with an effective amount of cannabidiol. However, the reference claims do not teach that sleep disturbances are treated with cannabidiol in ADS subjects.
Fleury-Teixeira teaches the treatment of 18 individuals diagnosed with Autism Spectrum Disorder (ASD) by administering cannabidiol-enriched (CBD) Cannabis Sativa extract (CE) (Abstract; Pg. 3, col.1, last para, p 4, col. 2, continued paragraph). Fleury-Teixeira teaches robust results in the improvement of sleep disorders in patients who adhered to the treatment (Pg. 5, first column, first paragraph; Pg. 5, second column, continued paragraph; TABLE 2; FIGURE 1A). Fleury-Teixeira teaches an improvement in sleep quality in two patients (Pg. 5, second column, first full paragraph). The reference teach CBD daily dose ranging from 100 mg/day to 350 mg/day (TABLE 1). This overlaps the claimed about 250 mg to about 1000 mg total daily. The reference teaches an administration schedule of two daily doses (Pg. 3, second column, first full paragraph; TABLE 1). The CBD as a CBD-enriched Cannabis Sativa extract (CE) is taught (Pg. 3, col. 2, contd para 2, pg. 7, col. 2, para 4).
From the teachings of Fleury-Teixeira it is obvious that ASD subjects have sleep disorders and they are treated upon administration of cannabidiol. Hence a skilled artisan would have found it obvious to arrive at the instantly claimed method from the reference claims and the prior art. Thus claims 1, 20 would have been obvious. As to the amount in claim 4, it is taught by the prior art. As to claim 5, if 10 mg/kg is administered to 70 kg patient (average weight of a subject), 700 mg is administered. This amount falls within the range that is taught by the prior art. As to claims 6-7, they are to dosage regimen and it can be routinely adjusted by a physician based on the subject’s condition, need etc. As to claims 8-9, 23, administration of the same agent, herein in same set of subjects with sleep disturbances will result in the same pharmacological effects of sleep improvement (e.g. total sleep), circadian rhythm is maintained or improved. As to claims 10-11, a person skilled in the art would have found it obvious to administer pure CBD or synthetic CBD to achieve therapeutic effects in the subject. As to claim 13, the reference claim teaches the use of cannabidiol in general and that includes both the racemic forms. It is well known in the art to separate the racemic mixtures to different forms and is within the skill of an artisan to use (-) cannabidiol in the method.
Conclusion
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/Umamaheswari Ramachandran/ Primary Examiner, Art Unit 1627