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
Claims 1-6 and 8-20 are pending in the application in consideration of Applicant’s preliminary claim amendments submitted 01/05/2024. It is noted that the markings to show changes to instant claim 4 is improper. See MPEP 714(II)(C)(B) for further information on the manner of making amendments. Claims 22-29 are cancelled. Claims 1-6 and 8-20 are examined herein.
Priority
This application is a 371 of PCT/IB2021/061335 filed 12/03/2021, which claims priority to provisional applications PRO 63/142,820 filed 01/28/2021 and PRO 63/121,076 filed 12/03/2020.
Information Disclosure Statement
The information disclosure statement submitted 01/05/2024 has been considered. The submission is in compliance with the provisions of 37 CFR 1.97.
Claim Objections
Claim 13 is objected to because of the following informalities:
In claim 13, line 1, the preposition “to” is missing between “according” and “claim 1”. It is suggested Applicants amend claim 13 to “The method [[according ]]of claim 1” for consistency of claim language.
(Similarly, Applicants may amend claims 5-6 to “The method [[according to]]of claim 1” for consistency of claim language.)
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 20 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 20, the claim depends from itself, which is improper.
For the purpose of applying prior art, claim 20 has been interpreted as being dependent from claim 19.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim interpretation
The instant specification does not define the term “about” recited in claim 6. The term “about” in instant claim 6 has been interpreted to be inclusive of a range of ±10% of the recited effective amount.
Claim Rejections - 35 USC § 102
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 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 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.
Claims 1-3, 6, 12-14 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fleury-Teixeira et al. (Effects of CBD-Enriched Cannabis sativa Extract on Autism Spectrum Disorder Symptoms: An Observational Study of 18 Participants Undergoing Compassionate Use, 31 October 2019, hereinafter Fleury-Teixeira, in the IDS).
Regarding instant claims 1-3, Fleury-Teixeira teaches the treatment of 18 individuals diagnosed with Autism Spectrum Disorder (ASD) by orally administering cannabidiol-enriched (CBD) Cannabis Sativa extract (CE) (Abstract; Pg. 3, first column, last paragraph – Pg. 3, second column, continued paragraph). Fleury-Teixeira teaches five epileptic patients among the cohort, of which two were diagnosed to have refractory epilepsy (Pg. 3, first column, first paragraph). Fleury-Teixeira teaches impressive results for the control of seizures in the five epileptic patients, with seizure reduction of 50% in three cases and 100% in the other two cases (Pg. 5, second column, continued paragraph; TABLE 2; FIGURE 1A) (this aligns with the definition of “treating” as defined in Para. [0032] of the instant specification – “mitigating, improving, relieving, or alleviating”). Fleury-Teixeira teaches the cohort of 18 ASD patients were aged 6-17 years (Pg. 3, first column, first paragraph; TABLE 1). Therefore, the disclosure of Fleury-Teixeira anticipates the 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, as in instant claims 1-3.
Regarding instant claim 6, Fleury-Teixeira teaches administering CBD at a 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, and is therefore, considered anticipated.
Regarding instant claim 12, Fleury-Teixeira teaches an administration schedule of two daily doses (Pg. 3, second column, first full paragraph; TABLE 1).
Regarding instant claims 13-14, 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). Therefore, Fleury-Teixeira anticipates the limitations of instant claims 13-14.
Regarding instant claim 17, Fleury-Teixeira teaches the CBD as a CBD-enriched Cannabis Sativa extract (CE) (Pg. 3, second column, continued paragraph – second full paragraph; Pg. 7, second column, fourth paragraph). Therefore, Fleury-Teixeira anticipates botanically derived CBD.
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 4-5, 8-11, 15-16 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Fleury-Teixeira et al. (Effects of CBD-Enriched Cannabis sativa Extract on Autism Spectrum Disorder Symptoms: An Observational Study of 18 Participants Undergoing Compassionate Use, 31 October 2019, hereinafter Fleury-Teixeira, in the IDS) as applied to claims 1-3, 6, 12-14 and 17 above, and further in view of Gutterman et al. (US 2019/0083388 A1, 21 March 2019, hereinafter Gutterman).
The teachings of Fleury-Teixeira are set forth in the anticipation rejection above and incorporated herein by reference.
Regarding instant claims 4-5, Fleury-Teixeira anticipates the method of treating refractory seizures in a human subject diagnosed with autism spectrum disorder (ASD), as in instant claim 1. Fleury-Teixeira do not teach wherein one or more refractory seizure type that is treated is selected from the group consisting of focal impaired awareness seizures (FIAS), generalized tonic-clonic seizures (GTCS), or focal to bilateral tonic-clonic seizures (FBTCS); wherein the CBD is administered transdermally.
Gutterman teaches a method of reducing seizure frequency in a subject having epilepsy by transdermally administering an effective amount of cannabidiol (CBD) to the subject wherein the seizure frequency is reduced (Para. [0002]; Para. [0046]; Claim 1). Gutterman teaches reducing focal impaired awareness seizures, focal onset seizures with generalized tonic-clonic seizures (Para. [0008]; Para. [0066]; Claim 6; Claim 7) and drug resistant (i.e., refractory) epilepsy (Para. [0009]; Claim 9). Gutterman teaches various benefits of transdermal administration of CBD, such as, it avoids first-pass liver metabolism, with higher bioavailability and improved safety profile, avoids the gastro intestinal (GI) tract, lessening the opportunity for GI related adverse events and the potential degradation of CBD by gastric acid into THC, which may be associated with unwanted psychoactive and/or euphoric effects (Para. [0049]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, in view of the teachings of Fleury-Teixeira and Gutterman, to have substituted the oral dosage of CBD with a transdermal dosage as taught by Gutterman in a method of treating refractory seizures in a human subject diagnosed with ASD, to arrive at the instant mode of administration with a reasonable expectation of success. Moreover, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, in view of the teachings of Fleury-Teixeira and Gutterman, wherein the refractory seizure being treated in a human subject diagnosed with ASD, is focal impaired awareness seizure/generalized tonic-clonic seizure, to arrive at the instant method claims with a reasonable expectation of success. The motivation being to broaden the scope of treatment and avoid psychoactive and/or euphoric effects and/or GI related adverse events, thereby improving treatment outcomes (Gutterman, Para. [0049]).
Regarding instant claims 8-11, Fleury-Teixeira anticipates the method of treating refractory seizures in a human subject diagnosed with autism spectrum disorder (ASD), as in instant claim 1. Fleury-Teixeira do not teach wherein the effective amount of CBD is 500 mg total daily; wherein the effective amount of CBD is 750 mg total daily; wherein the effective amount of CBD is 1000 mg total daily; wherein the CBD is administered in a single daily dose. Fleury-Teixeira teaches administering CBD at a daily dose ranging from 100 mg/day to 350 mg/day (TABLE 1). Fleury-Teixeira teaches standardized CE doses were established individually by a titration process within a dose range based on CBD doses previously reported for use of CBD-enriched CEs for treatment of refractory epilepsy associated with regressive autism (Pg. 3, second column, first full paragraph).
Gutterman teaches an effective amount of CBD can be between about 195 mg and about 780 mg total daily (Para. [0012]; Claim 12) and wherein the CBD is administered in a single daily dose (Para. [0012]; Claim 22).
According to MPEP 2144.05(II)(A), "[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). Therefore, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed amounts of CBD/claimed treatment schedule of a single daily dose, in the absence of any criticality of the recited amounts/schedules. The optimal dosing would have been determined taking into consideration a variety of factors, such as the age, weight, sex, diet, severity of the medical condition of the patient and pharmacological considerations, such as activity, efficacy, pharmacokinetics and toxicology profiles. This is well within the skill of a person of ordinary skill in the pharmaceutical arts.
Regarding instant claims 15-16 and 18-20, Fleury-Teixeira anticipates the method of treating refractory seizures in a human subject diagnosed with autism spectrum disorder (ASD), as in instant claim 1. Fleury-Teixeira do not teach wherein the CBD is a synthetic CBD; wherein the CBD is a pure CBD; wherein the cannabidiol is (-)-cannabidiol; wherein the CBD is formulated as a gel; wherein the CBD is formulated as a permeation-enhanced gel.
Gutterman teaches wherein the CBD is a synthetic CBD (Para. [0011]; Claim 24); wherein the CBD is a pure CBD (Para. [0011]; Claim 25); wherein the cannabidiol is (-)-cannabidiol (Para. [0011]; Claim 11); wherein the CBD is formulated as a gel (Para. [0015]; Claim 20); wherein the CBD is formulated as a permeation-enhanced gel (Para. [0015]; Claim 21). Gutterman teaches the permeation-enhanced gel is designed to provide controlled drug delivery transdermally with once- or twice-daily dosing (Paras. [0050]-[0051]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, in view of the teachings of Fleury-Teixeira and Gutterman, to have formulated synthetic CBD/pure CBD/(-)-cannabidiol (the active naturally occurring enantiomer obtained from the Cannabis plant) for use in a method of treating refractory seizures in a human subject diagnosed with autism spectrum disorder (ASD), with a reasonable expectation of success. The motivation being to avoid the unwanted psychoactive and/or euphoric effects of THC (Gutterman, Para. [0049]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, in view of the teachings of Fleury-Teixeira and Gutterman, to have formulated and a permeation-enhanced gel, for use in a method of treating refractory seizures in a human subject diagnosed with autism spectrum disorder (ASD) as instantly claimed, with a reasonable expectation of success. The motivation being to provide an exemplary formulation with good safety profile, optimal tolerability profile and controlled delivery of CBD, thereby improving treatment outcomes (Gutterman, Para. [0085]; [0089]).
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 3, 5-6, 8-16 and 18-20 are provisionally rejected on the ground of obviousness type nonstatutory double patenting as being unpatentable over claims 1, 3-4, 6-11, 13-15 and 21 of co-pending Application No 18/362,092.
Although the claims at issue are not identical, both sets of claims are drawn to a method of treatment in a human subject having Autism spectrum disorder (ASD) co-morbid with a refractory type of seizure, comprising administering an effective amount of cannabidiol (CBD) to the subject in need thereof.
The instant 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.
The claims of the co-pending Application No 18/362,092 are drawn to method of treating sleep disturbances in a human subject, the method comprising: administering an effective amount of cannabidiol (CBD) to the human in need thereof to treat the sleep disturbances.
Claim 21 of the reference ‘092 application teaches a subject afflicted with DEE-ASD (i.e., developmental and epileptic encephalopathy, wherein the subject has a refractory type of seizure)/autism spectrum disorder. Claim 21 of the reference ‘092 application anticipates the patient population of instant claim 1. Claim 3 of the reference ‘092 application anticipates the transdermal administration of CBD of instant claim 5. Claim 4 of the reference ‘092 application anticipates the dosages of CBD as in instant claims 6-10. Claims 6-7 of the reference ‘092 application anticipates the treatment schedule of CBD as in instant claims 11-12. Claims 1 and 8-9 of the reference ‘092 application anticipates treating sleep-related symptoms as in instant claims 13-14. Claims 10-11, 13-15 of the reference ‘092 application anticipates the forms/dosage formulations of CBD as in instant claims 15-16, 18-20.
Consequently, carrying out the method of claim 21 of the reference ‘092 application, would necessarily result in the method of instant claim 1.
Therefore, instant claims 1, 3, 5-6, 8-16 and 18-20 and claims 1, 3-4, 6-11, 13-15 and 21 of co-pending Application No 18/362,092 are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3-6, 8-12 and 15 are provisionally rejected on the ground of obviousness type nonstatutory double patenting as being unpatentable over claims 1, 9 and 11-14 of co-pending Application No 17/697,629 in view of Fleury-Teixeira et al. (Effects of CBD-Enriched Cannabis sativa Extract on Autism Spectrum Disorder Symptoms: An Observational Study of 18 Participants Undergoing Compassionate Use, 31 October 2019, hereinafter Fleury-Teixeira, in the IDS).
Although the claims at issue are not identical, both sets of claims are drawn to a method of treatment in a subject having a refractory type of seizure, comprising administering an effective amount of cannabidiol (CBD) to the subject in need thereof.
The instant 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.
The claims of the co-pending Application No 17/697,629 are drawn to method of treating behavioral problems and seizures in a subject having developmental and epileptic encephalopathy (DEE), the method comprising: transdermally administering an effective amount of cannabidiol (CBD) to the subject, wherein behavioral problems are treated in the subject; and wherein the seizures treated are focal impaired awareness seizures (FIAS).
Claim 1 of the reference ‘629 application teaches a method of treating a refractory type seizure (DEE) in a subject by administering transdermally administering an effective amount of cannabidiol (CBD) to the subject, wherein the seizures treated are focal impaired awareness seizures (FIAS). The reference ‘629 application does not teach the subject having DEE is also diagnosed to have ASD.
Fleury-Teixeira teaches the treatment of 18 individuals diagnosed with Autism Spectrum Disorder (ASD) by orally administering cannabidiol-enriched (CBD) Cannabis Sativa extract (CE) (Abstract; Pg. 3, first column, last paragraph – Pg. 3, second column, continued paragraph). Fleury-Teixeira teaches five epileptic patients among the cohort, of which two were diagnosed to have refractory epilepsy (Pg. 3, first column, first paragraph). Fleury-Teixeira teaches impressive results for the control of seizures in the five epileptic patients, with seizure reduction of 50% in three cases and 100% in the other two cases (Pg. 5, second column, continued paragraph; TABLE 2; FIGURE 1A).
The teachings of the reference ‘629 application in view of Fleury-Teixeira would motivate a person of ordinary skill in the art to treat a subject with a refractory type seizure and further diagnosed with ASD, comprising administering an effective amount of cannabidiol (CBD) to the human in need thereof, to arrive at the instant method claims with a reasonable expectation of success. Claims 1 and 9 of the reference ‘629 application in view of Fleury-Teixeira renders obvious the limitations of instant claims 1 and 3-5. Claims 11-14 of the reference ‘629 application in view of Fleury-Teixeira renders obvious the form of CBD and dosages of CBD as in instant claims 6, 8-12 and 15.
Therefore, instant claims 1, 3-6, 8-12 and 15 and claims 1, 9 and 11-14 and 21 of co-pending Application No 17/697,629 are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3 and 5 are provisionally rejected on the ground of obviousness type nonstatutory double patenting as being unpatentable over claim 1 of co-pending Application No 18/765,056 in view of Fleury-Teixeira et al. (Effects of CBD-Enriched Cannabis sativa Extract on Autism Spectrum Disorder Symptoms: An Observational Study of 18 Participants Undergoing Compassionate Use, 31 October 2019, hereinafter Fleury-Teixeira, in the IDS).
Although the claims at issue are not identical, both sets of claims are drawn to a method of treatment in a subject having epilepsy, comprising administering an effective amount of cannabidiol (CBD) to the subject in need thereof.
The instant 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.
The claims of the co-pending Application No 18/765,056 are drawn to method of reducing seizure frequency in a subject having epilepsy, the method comprising: transdermally administering an effective amount of cannabidiol (CBD) to the subject wherein the seizure frequency is reduced.
The reference ‘056 application does not teach treating a subject having a refractory seizure and diagnosed with ASD.
Fleury-Teixeira teaches the treatment of 18 individuals diagnosed with Autism Spectrum Disorder (ASD) by orally administering cannabidiol-enriched (CBD) Cannabis Sativa extract (CE) (Abstract; Pg. 3, first column, last paragraph – Pg. 3, second column, continued paragraph). Fleury-Teixeira teaches five epileptic patients among the cohort, of which two were diagnosed to have refractory epilepsy (Pg. 3, first column, first paragraph). Fleury-Teixeira teaches impressive results for the control of seizures in the five epileptic patients, with seizure reduction of 50% in three cases and 100% in the other two cases (Pg. 5, second column, continued paragraph; TABLE 2; FIGURE 1A).
The teachings of the reference ‘056 application in view of Fleury-Teixeira would motivate a person of ordinary skill in the art to treat a subject with a refractory type seizure and further diagnosed with ASD, comprising administering an effective amount of cannabidiol (CBD) to the human in need thereof to arrive at the instant method claims, with a reasonable expectation of success. Claim 1 of the reference ‘056 application in view of Fleury-Teixeira renders obvious the limitations of instant claims 1, 3 and 5.
Therefore, instant claims 1, 3 and 5 and claim 1 of co-pending Application No 18/765,056 are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3 and 5 are provisionally rejected on the ground of obviousness type nonstatutory double patenting as being unpatentable over claim 1 of co-pending Application No 19/039,288 in view of Fleury-Teixeira et al. (Effects of CBD-Enriched Cannabis sativa Extract on Autism Spectrum Disorder Symptoms: An Observational Study of 18 Participants Undergoing Compassionate Use, 31 October 2019, hereinafter Fleury-Teixeira, in the IDS).
Although the claims at issue are not identical, both sets of claims are drawn to a method of treatment in a subject having epilepsy, comprising administering an effective amount of cannabidiol (CBD) to the subject in need thereof.
The instant 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.
The claims of the co-pending Application No 19/039,288 are drawn to method of reducing seizure frequency in a subject having epilepsy, the method comprising: transdermally administering an effective amount of cannabidiol (CBD) to the subject wherein the seizure frequency is reduced.
The reference ‘288 application does not teach treating a subject having a refractory seizure and diagnosed with ASD.
Fleury-Teixeira teaches the treatment of 18 individuals diagnosed with Autism Spectrum Disorder (ASD) by orally administering cannabidiol-enriched (CBD) Cannabis Sativa extract (CE) (Abstract; Pg. 3, first column, last paragraph – Pg. 3, second column, continued paragraph). Fleury-Teixeira teaches five epileptic patients among the cohort, of which two were diagnosed to have refractory epilepsy (Pg. 3, first column, first paragraph). Fleury-Teixeira teaches impressive results for the control of seizures in the five epileptic patients, with seizure reduction of 50% in three cases and 100% in the other two cases (Pg. 5, second column, continued paragraph; TABLE 2; FIGURE 1A).
The teachings of the reference ‘288 application in view of Fleury-Teixeira would motivate a person of ordinary skill in the art to treat a subject with a refractory type seizure and further diagnosed with ASD, comprising administering an effective amount of cannabidiol (CBD) to the human in need thereof to arrive at the instant method claims, with a reasonable expectation of success. Claim 1 of the reference ‘288 application in view of Fleury-Teixeira renders obvious the limitations of instant claims 1, 3 and 5.
Therefore, instant claims 1, 3 and 5 and claim 1 of co-pending Application No 19/039,288 are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3, 5-6, 8-10, 12 and 15-17 are provisionally rejected on the ground of obviousness type nonstatutory double patenting as being unpatentable over claims 1, 12 and 14-20 of co-pending Application No 19/224,281 in view of Fleury-Teixeira et al. (Effects of CBD-Enriched Cannabis sativa Extract on Autism Spectrum Disorder Symptoms: An Observational Study of 18 Participants Undergoing Compassionate Use, 31 October 2019, hereinafter Fleury-Teixeira, in the IDS).
Although the claims at issue are not identical, both sets of claims are drawn to a method of treatment in a subject having autism spectrum disorder, comprising administering an effective amount of cannabidiol (CBD) to the subject in need thereof.
The instant 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.
The claims of the co-pending Application No 19/224,281 are drawn to 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.
The reference ‘281 application does not teach treating a subject having a refractory seizure and diagnosed with ASD.
Fleury-Teixeira teaches the treatment of 18 individuals diagnosed with Autism Spectrum Disorder (ASD) by orally administering cannabidiol-enriched (CBD) Cannabis Sativa extract (CE) (Abstract; Pg. 3, first column, last paragraph – Pg. 3, second column, continued paragraph). Fleury-Teixeira teaches five epileptic patients among the cohort, of which two were diagnosed to have refractory epilepsy (Pg. 3, first column, first paragraph). Fleury-Teixeira teaches impressive results for the control of seizures in the five epileptic patients, with seizure reduction of 50% in three cases and 100% in the other two cases (Pg. 5, second column, continued paragraph; TABLE 2; FIGURE 1A).
The teachings of the reference ‘281 application in view of Fleury-Teixeira would motivate a person of ordinary skill in the art to treat a subject with a refractory type seizure and further diagnosed with ASD, comprising administering an effective amount of cannabidiol (CBD) to the human in need thereof to arrive at the instant method claims, with a reasonable expectation of success. Claim 1 of the reference ‘281 application in view of Fleury-Teixeira renders obvious the limitations of instant claims 1 and 3. Claim 12 of the reference ‘281 application in view of Fleury-Teixeira renders obvious the limitations of instant claim 5 drawn to a transdermal administration of CBD. Claims 14-16 of the reference ‘281 application renders obvious the dosage/treatment schedule of the CBD administered as in instant claims 6, 8-10 and 12. Claims 17-20 of the reference ‘281 application renders obvious the limitations of instant claims 15-17 drawn to the type of CBD administered.
Therefore, instant claims 1, 3, 5-6, 8-10, 12 and 15-17 and claims 1, 12 and 14-20 of co-pending Application No 19/224,281 are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3 and 5 are provisionally rejected on the ground of obviousness type nonstatutory double patenting as being unpatentable over claim 1 of co-pending Application No 19/008,407 in view of Fleury-Teixeira et al. (Effects of CBD-Enriched Cannabis sativa Extract on Autism Spectrum Disorder Symptoms: An Observational Study of 18 Participants Undergoing Compassionate Use, 31 October 2019, hereinafter Fleury-Teixeira, in the IDS).
Although the claims at issue are not identical, both sets of claims are drawn to a method of treating a subject having autism spectrum disorder, comprising administering an effective amount of cannabidiol (CBD) to the subject in need thereof.
The instant 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.
The claims of the co-pending Application No 19/008,407 are drawn to 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.
The reference ‘407 application does not teach treating a subject having a refractory seizure and diagnosed with ASD.
Fleury-Teixeira teaches the treatment of 18 individuals diagnosed with Autism Spectrum Disorder (ASD) by orally administering cannabidiol-enriched (CBD) Cannabis Sativa extract (CE) (Abstract; Pg. 3, first column, last paragraph – Pg. 3, second column, continued paragraph). Fleury-Teixeira teaches five epileptic patients among the cohort, of which two were diagnosed to have refractory epilepsy (Pg. 3, first column, first paragraph). Fleury-Teixeira teaches impressive results for the control of seizures in the five epileptic patients, with seizure reduction of 50% in three cases and 100% in the other two cases (Pg. 5, second column, continued paragraph; TABLE 2; FIGURE 1A).
The teachings of the reference ‘407 application in view of Fleury-Teixeira would motivate a person of ordinary skill in the art to treat a subject with a refractory type seizure and further diagnosed with ASD, comprising administering an effective amount of cannabidiol (CBD) to the human in need thereof to arrive at the instant method claims, with a reasonable expectation of success. Claim 1 of the reference ‘407 application in view of Fleury-Teixeira renders obvious the limitations of instant claims 1, 3 and 5.
Therefore, instant claims 1, 3 and 5 and claim 1 of co-pending Application No 19/008,407 are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3, 5-6, 8-10, 12 and 15-17 are provisionally rejected on the ground of obviousness type nonstatutory double patenting as being unpatentable over claims 1, 5 and 7-15 of co-pending Application No 18/642,059 in view of Fleury-Teixeira et al. (Effects of CBD-Enriched Cannabis sativa Extract on Autism Spectrum Disorder Symptoms: An Observational Study of 18 Participants Undergoing Compassionate Use, 31 October 2019, hereinafter Fleury-Teixeira, in the IDS).
Although the claims at issue are not identical, both sets of claims are drawn to a method of treatment in a subject having autism spectrum disorder, comprising administering an effective amount of cannabidiol (CBD) to the subject in need thereof.
The instant 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.
The claims of the co-pending Application No 18/642,059 are drawn to 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 irritability in a subject is treated.
The reference ‘059 application does not teach treating a subject having a refractory seizure and diagnosed with ASD.
Fleury-Teixeira teaches the treatment of 18 individuals diagnosed with Autism Spectrum Disorder (ASD) by orally administering cannabidiol-enriched (CBD) Cannabis Sativa extract (CE) (Abstract; Pg. 3, first column, last paragraph – Pg. 3, second column, continued paragraph). Fleury-Teixeira teaches five epileptic patients among the cohort, of which two were diagnosed to have refractory epilepsy (Pg. 3, first column, first paragraph). Fleury-Teixeira teaches impressive results for the control of seizures in the five epileptic patients, with seizure reduction of 50% in three cases and 100% in the other two cases (Pg. 5, second column, continued paragraph; TABLE 2; FIGURE 1A).
The teachings of the reference ‘059 application in view of Fleury-Teixeira would motivate a person of ordinary skill in the art to treat a subject with a refractory type seizure and further diagnosed with ASD, comprising administering an effective amount of cannabidiol (CBD) to the human in need thereof to arrive at the instant method claims, with a reasonable expectation of success. Claims 1 and 5 of the reference ‘059 application in view of Fleury-Teixeira renders obvious the limitations of instant claims 1 and 3. Claim 7 of the reference ‘059 application renders obvious the limitations of instant claim 5 drawn to a transdermal administration of CBD. Claims 10-14 of the reference ‘059 application renders obvious the dosage/treatment schedule of the CBD administered as in instant claims 6, 8-10 and 12. Claims 8-9 and 15 of the reference ‘059 application renders obvious the limitations of instant claims 15-17 drawn to the type of CBD administered.
Therefore, instant claims 1, 3, 5-6, 8-10, 12 and 15-17 and claims 1, 5 and 7-15 of co-pending Application No 18/642,059 are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3, 5-12, 15 and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 10,314,792 B2 in view of Fleury-Teixeira et al. (Effects of CBD-Enriched Cannabis sativa Extract on Autism Spectrum Disorder Symptoms: An Observational Study of 18 Participants Undergoing Compassionate Use, 31 October 2019, hereinafter Fleury-Teixeira, in the IDS).
Although the claims at issue are not identical, both sets of claims are drawn to a method of treating a subject having autism spectrum disorder, comprising administering an effective amount of cannabidiol (CBD) to the subject in need thereof.
The instant 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.
The claims of the reference ‘792 patent are drawn 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.
The reference ‘792 patent does not teach treating a subject having a refractory seizure and diagnosed with ASD.
Fleury-Teixeira teaches the treatment of 18 individuals diagnosed with Autism Spectrum Disorder (ASD) by orally administering cannabidiol-enriched (CBD) Cannabis Sativa extract (CE) (Abstract; Pg. 3, first column, last paragraph – Pg. 3, second column, continued paragraph). Fleury-Teixeira teaches five epileptic patients among the cohort, of which two were diagnosed to have refractory epilepsy (Pg. 3, first column, first paragraph). Fleury-Teixeira teaches impressive results for the control of seizures in the five epileptic patients, with seizure reduction of 50% in three cases and 100% in the other two cases (Pg. 5, second column, continued paragraph; TABLE 2; FIGURE 1A).
The teachings of the reference ‘792 patent in view of Fleury-Teixeira would motivate a person of ordinary skill in the art to treat a subject with a refractory type seizure and further diagnosed with ASD, comprising administering an effective amount of cannabidiol (CBD) to the human in need thereof to arrive at the instant method claims, with a reasonable expectation of success. Claim 1 of the reference ‘792 patent in view of Fleury-Teixeira renders obvious the limitations of instant claims 1 and 15. Claims 2, 5-6 of the reference ‘792 patent renders obvious the dosage/treatment schedule limitations of instant claims 6, 8-12. Claims 1-2 of the reference ‘792 patent renders obvious the limitations of instant claims 15, 18 drawn to the type of CBD administered. Claim 7 of the reference ‘792 patent renders obvious the limitations of instant claim 5 drawn to transdermal formulation of CBD administered. Claim 4 of the reference ‘792 patent renders obvious the limitations of instant claims 19-20 drawn to the dosage form of CBD administered.
The instant claims 1, 3, 5-12, 15 and 18-20 and claims 1-7 of the ‘792 patent are therefore not patentably distinct.
This is a nonstatutory double patenting rejection.
Claims 1, 3, 5-12, 16 and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 10,568,848 B2 in view of Fleury-Teixeira et al. (Effects of CBD-Enriched Cannabis sativa Extract on Autism Spectrum Disorder Symptoms: An Observational Study of 18 Participants Undergoing Compassionate Use, 31 October 2019, hereinafter Fleury-Teixeira, in the IDS).
Although the claims at issue are not identical, both sets of claims are drawn to a method of treating a subject having autism spectrum disorder, comprising administering an effective amount of cannabidiol (CBD) to the subject in need thereof.
The instant 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.
The claims of the reference ‘848 patent are drawn 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.
The reference ‘848 patent does not teach treating a subject having a refractory seizure and diagnosed with ASD.
Fleury-Teixeira teaches the treatment of 18 individuals diagnosed with Autism Spectrum Disorder (ASD) by orally administering cannabidiol-enriched (CBD) Cannabis Sativa extract (CE) (Abstract; Pg. 3, first column, last paragraph – Pg. 3, second column, continued paragraph). Fleury-Teixeira teaches five epileptic patients among the cohort, of which two were diagnosed to have refractory epilepsy (Pg. 3, first column, first paragraph). Fleury-Teixeira teaches impressive results for the control of seizures in the five epileptic patients, with seizure reduction of 50% in three cases and 100% in the other two cases (Pg. 5, second column, continued paragraph; TABLE 2; FIGURE 1A).
The teachings of the reference ‘848 patent in view of Fleury-Teixeira would motivate a person of ordinary skill in the art to treat a subject with a refractory type seizure and further diagnosed with ASD, comprising administering an effective amount of cannabidiol (CBD) to the human in need thereof to arrive at the instant method claims, with a reasonable expectation of success. Claim 1 of the reference ‘848 patent in view of Fleury-Teixeira renders obvious the limitations of instant claims 1 and 5. Claims 3-4 and 6-8 of the reference ‘848 patent renders obvious the dosage/treatment schedule limitations of instant claims 6, 8-12. Claims 1-2 of the reference ‘848 patent renders obvious the limitations of instant claims 16, 18 drawn to the type of CBD administered. Claim 5 of the reference ‘848 patent renders obvious the limitations of instant claims 19-20 drawn to the dosage form of CBD administered.
The instant claims 1, 3, 5-12, 16 and 18-20 and claims 1-8 of the ‘848 patent are therefore not patentably distinct.
This is a nonstatutory double patenting rejection.
Claims 1, 3, 5-12, 16 and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,213,951 B2 in view of Fleury-Teixeira et al. (Effects of CBD-Enriched Cannabis sativa Extract on Autism Spectrum Disorder Symptoms: An Observational Study of 18 Participants Undergoing Compassionate Use, 31 October 2019, hereinafter Fleury-Teixeira, in the IDS).
Although the claims at issue are not identical, both sets of claims are drawn to a method of treating a subject having autism spectrum disorder, comprising administering an effective amount of cannabidiol (CBD) to the subject in need thereof.
The instant 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.
The claims of the reference ‘951 patent are drawn 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.
The reference ‘951 patent does not teach treating a subject having a refractory seizure and diagnosed with ASD.
Fleury-Teixeira teaches the treatment of 18 individuals diagnosed with Autism Spectrum Disorder (ASD) by orally administering cannabidiol-enriched (CBD) Cannabis Sativa extract (CE) (Abstract; Pg. 3, first column, last paragraph – Pg. 3, second column, continued paragraph). Fleury-Teixeira teaches five epileptic patients among the cohort, of which two were diagnosed to have refractory epilepsy (Pg. 3, first column, first paragraph). Fleury-Teixeira teaches impressive results for the control of seizures in the five epileptic patients, with seizure reduction of 50% in three cases and 100% in the other two cases (Pg. 5, second column, continued paragraph; TABLE 2; FIGURE 1A).
The teachings of the reference ‘951 patent in view of Fleury-Teixeira would motivate a person of ordinary skill in the art to treat a subject with a refractory type seizure and further diagnosed with ASD, comprising administering an effective amount of cannabidiol (CBD) to the human in need thereof to arrive at the instant method claims, with a reasonable expectation of success. Claim 1 of the reference ‘951 patent in view of Fleury-Teixeira renders obvious the limitations of instant claims 1 and 5. Claims 3-4 and 6-8 of the reference ‘951 patent renders obvious the dosage/treatment schedule limitations of instant claims 6, 8-12. Claims 1-2 of the reference ‘‘951 patent renders obvious the limitations of instant claims 16, 18 drawn to the type of CBD administered. Claim 5 of the reference ‘951 patent renders obvious the limitations of instant claims 19-20 drawn to the dosage form of CBD administered.
The instant claims 1, 3, 5-12, 16 and 18-20 and claims 1-8 of the ‘951 patent are therefore not patentably distinct.
This is a nonstatutory double patenting rejection.
Conclusion
Claims 1-6 and 8-20 are rejected.
Claim 13 is objected to.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PADMAJA S RAO whose telephone number is (571) 272-9918. The examiner can normally be reached 9:00-5:30 pm EDT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney L Klinkel can be reached on (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Infor