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 .
Priority
This Application is a 371 of PCT/US2021/057931, filed Nov. 3, 2021. The effective filing date of the instant invention is Nov. 3, 2021.
This application claims priority to U.S. Patent Application No. 17/225,738 filed April 08, 2021, which claims priority to U.S. Provisional Application No. 63/114,194 filed November 16, 2020; U.S. Provisional Application No. 63/114,181 filed November 16, 2020; U.S. Provisional Application No. 63/147,453 filed February 09, 2021; U.S. Provisional Application No. 63/172,343 filed April 08, 2021; U.S. Provisional Application No. 63/172,362 filed April 08, 2021; U.S. Provisional Application No. 63/172,386 filed April 08, 2021; U.S. Provisional Application No. 63/172,368 filed April 08, 2021; and U.S. Provisional Application No. 63/180,193 filed April 27, 2021; however, none of these applications provide support for the primary claim limitation of administering the composition comprising CBD for the treatment of symptoms of autism spectrum disorder.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on May 11, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 1, 3-10 and 12-34 are currently pending and subject to examination.
Claim Rejections - 35 USC § 112(b) – Previously Presented
The following is a quotation of 35 U.S.C. 112(b):
“(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.”
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
“The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.”
The rejection of claims 21, 25, 27 and 31-32 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 is maintained.
Response to Arguments
The Applicant argues that claims 21, 25, and 27 specify the amount of the drug administered to the patient and not the amount of drug present in the composition (Remarks, p. 6-8). These arguments were fully considered but are not persuasive. The therapeutically effective amount specifically refers to the amount of CBD present within the composition (claim 1). The therapeutically effective amount of claims 21, 25, and 27 defines that amount using units (mg/kg/day or mg/day) that do not actually describe what is in the composition, but describe an administration parameter. The therapeutically effective amount of CBD in the composition (the therapeutically effective amount of CBD as in claim 1) is different than the therapeutically effective amount of CBD as the administration parameter as in claims 21, 25 and 27, as admitted by the Applicant “mg/kg/day and mg/day… are not… recitations of the composition’s unit dose content” (Remarks, p. 7). Therefore, the claims are at least indefinite for a lack of antecedent basis for “the therapeutically effective amount” because the Applicant admits this is not the “a therapeutically effective amount” as in claim 1.
The Applicant argues that claims 31-32 are definite because they use a quantitative metric (Remarks, p. 8-9). These arguments were fully considered but are not persuasive. The quantitative metric is not a metric as to a physical property of the composition. The quantitative metric refers to an outcome following the administration of the composition. The boundaries of the claim are unclear because one of ordinary skill in the art would not know what structures and administration steps lead to the claimed outcome. The specification describes numerous doses and administration regimens and it is unclear which of these compositions and regimens, if any, would lead to the claimed outcome. The specification does not provide any experimental data for the treatment of ASD or seizures. Therefore, in reading the claims and the specification, one of ordinary skill in the art would not know what methods would reduce the total convulsive frequency of the subject by at least 50% or 70% and how these functional requirements are further limiting to the method of claim 1.
Reiterated Rejection
Claims 21, 25, 27 and 31-32 are 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.
One of ordinary skill in the art cannot determine the metes and bounds of claims 21, 25 and 27 because claim 1 is directed towards a method of treating symptoms of autism spectrum disorder comprising administering a composition comprising (b) a therapeutically effective amount of cannabidiol and claim 23 further states that the composition further comprises an effective amount of an antipsychotic but claims 21, 25, and 27 list the therapeutically effective amount of CBD or antipsychotic in terms of mg/kg/day or mg/day. A composition does not contain a dose in the form of mg/day but rather in terms of mg. It is possible to administer a dosage to a patient in terms of mg/ day but it does not make sense to have a composition comprised of mg/day or mg/kg/day. Appropriate correction is required.
One of ordinary skill in the art cannot determine the metes and bounds of claims 31-32 because these claims merely recite a problem to be solved or a functional result achieved by the invention (convulsive frequency reduced by 50% or 70%), but do not provide a clear cut indication of how the composition or steps recited by the method of claim 29 are further limited. “For example, when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear. Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1255, 85 USPQ2d 1654, 1663 (Fed. Cir. 2008) (noting that the Supreme Court explained that a vice of functional claiming occurs "when the inventor is painstaking when he recites what has already been seen, and then uses conveniently functional language at the exact point of novelty") (quoting General Elec. Co. v. Wabash Appliance Corp., 304 U.S. 364, 371 (1938)).” (MPEP § 2173.05(g)).
Appropriate correction is required.
Claim Rejections – 35 USC § 103 – Previously Presented
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.
The rejection of claim(s) 1, 3-10, 16-22 and 28-34 under 35 U.S.C. 103 as being unpatentable over Fleury-Teixeira et al. (Front. Neurol., 30 October 2019, Sec. Neuropharmacology, Volume 10, No. 1145, p. 1-8) in view of “Catalent to Partner with Ethicann on New Fast-Dissolve Cannabinoid-Based Treatment for Multiple Sclerosis Spasticity” (Catalent, Dec 03, 2019, p. 1-4) (herein “Catalent”) and Grother et al. (; published Nov. 16, 2023; effectively filed Oct. 8, 2020) is maintained.
The rejection of claim(s) 1, 3-10, 12-13, 16-22 and 28-34 under 35 U.S.C. 103 as being unpatentable over Fleury-Teixeira et al. (Front. Neurol., 30 October 2019, Sec. Neuropharmacology, Volume 10, No. 1145, p. 1-8), “Catalent to Partner with Ethicann on New Fast-Dissolve Cannabinoid-Based Treatment for Multiple Sclerosis Spasticity” (Catalent, Dec 03, 2019, p. 1-4) (herein “Catalent”) and Grother et al. (US 2023/0364013 A1; published Nov. 16, 2023; effectively filed Oct. 8, 2020), as applied to claims 1-10, 16-22 and 28-34 above, and further in view of Marco (CBD Mania, Jan. 26, 2021, pp. 1-16) is maintained.
The rejection of claim(s) 1, 3-10, 14-22 and 28-34 under 35 U.S.C. 103 as being unpatentable over Fleury-Teixeira et al. (Front. Neurol., 30 October 2019, Sec. Neuropharmacology, Volume 10, No. 1145, p. 1-8), “Catalent to Partner with Ethicann on New Fast-Dissolve Cannabinoid-Based Treatment for Multiple Sclerosis Spasticity” (Catalent, Dec 03, 2019, p. 1-4) (herein “Catalent”) and Grother et al. (US 2023/0364013 A1; published Nov. 16, 2023; effectively filed Oct. 8, 2020), as applied to claims 1-10, 16-22 and 28-34 above, and further in view of Rock et al. (Psychopharmacology, vol. 237, pages 2621–2631, (2020), published 02 June 2020) is maintained.
The rejection of claim(s) 1, 3-10 and 16-34 under 35 U.S.C. 103 as being unpatentable over Fleury-Teixeira et al. (Front. Neurol., 30 October 2019, Sec. Neuropharmacology, Volume 10, No. 1145, p. 1-8), “Catalent to Partner with Ethicann on New Fast-Dissolve Cannabinoid-Based Treatment for Multiple Sclerosis Spasticity” (Catalent, Dec 03, 2019, p. 1-4) (herein “Catalent”) and Grother et al. (US 2023/0364013 A1; published Nov. 16, 2023; effectively filed Oct. 8, 2020), as applied to claims 1-10, 16-22 and 28-34 above, and further in view of Kikuchi et al. (US9017737B2, published April 28, 2015), Hobbs et al. (Drugs in R&D, Volume 13, pages 281–288, (2013), Published: 30 October 2013) and Grother et al. (JP2012121850A; published June 28, 2012) (herein “Otsuka”) citing to “Catalent Announces Commencement of Supply of Abilify® Orally Disintegrating Tablets to Otsuka Pharmaceutical Co. Ltd. and Extensive Investments to its Zydis® to Technology Capabilities in Swindon, UK” (American Pharmaceutical Review, July 25, 2012, p. 1-5) (herein “American Pharmaceutical Review”) is maintained.
Response to Arguments
The Applicant argues that Zydis ODT wafers are not known to provide increased oral mucosa uptake for insoluble drugs such as CBD and therefore one of ordinary skill in the art would not have a reasonable expectation of success to arrive at the claimed invention (Remarks, p. 12-14). These arguments were fully considered but are not persuasive. Catalent teaches CBD Zydis wafers. As demonstrated by Seager, cited by the Applicant, all Zydis wafers disintegrate in the mouth and the drug particles coat the oral cavity:
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Seager, Fig. 7.
Therefore, during the normal and usual operation of administering Zydis wafers, the CBD would be absorbed through the oral mucosa. The Applicant does not present a new and unique structure or method.
The Applicant argues that CBD is insoluble and cannot be dissolved by pH adjustment in an aqueous premix and therefore the method of Grother is inapplicable to CBD Zydis (Remarks, p. 12-14). The Applicant argues that there is no reasonable expectation of success because one of ordinary skill in the art could not have substituted insoluble CBD for soluble epinephrine in the method of Grother (id., p. 15). These arguments were fully considered but are not persuasive. One of ordinary skill in the art would have a reasonable expectation of success to substitute CBD for epinephrine in the method of Grother because Grother teaches that the API is in a solid form and should not dissolve in the pre-mix.
Grother teaches a suspension based product wherein the API is not dissolved in the pre-mix because this has improved properties with regards to a physical and chemical stability as compared to a solution based pre-mix (Grother, Specification, paragraph [0006]). Grother teaches that the pre-mix is prepared by mixing the solvent, matrix former, and structure former, adding a pH modifier to make the pH neutral to basic, and then adding the API to form a suspension (Grother, Specification, paragraph [0014]). Grother explicitly states that the formulation strategy was altered (with the pH modifier) to target a “freeze-dried, suspension-based epinephrine product… As used herein, a “suspension-based” formulation is a formulation in which the majority of the epinephrine is present within the formulation as undissolved, solid particles following mixing and prior to freezing and subsequent processing. This strategy was selected because the epinephrine API is known to be stable when in its solid (crystalline) state.” (id., paragraph [0009] (emphasis added)). The pH modifier is used to keep the epinephrine in suspension and undissolved in the pre-mix similar to an insoluble drug (id., Specification, paragraph [0113]), Therefore, one of ordinary skill in the art would know that suspensions are preferred as compared to solutions and that CBD Zydis wafers can be prepared using essentially the same method as Grother. The Applicant has demonstrated that the instantly claimed CBD wafers are made in essentially the same way as Grother’s wafers. The Applicant made a pre-mix with water, gelatin and mannitol and then suspended the solid crystalline CBD in the pre-mix prior to lyophilization (Specification, p. 54-55).
The Applicant argues that homogenizer-suspension based processing at a temperature of 20 to 35°C is absent from Grother and Marco (Remarks, p. 14). These arguments were fully considered but are not persuasive. Grother teaches that the suspension with the pre-mix plus API is maintained at a temperature of 5 to 35v (Grother, Specification, paragraph [0112]), overlapping the desired range in the instant invention. Grother also teaches that homogenization may improve the qualities of the drug product in terms of agglomeration and improved particle size distribution and should be tested during the optimization of this type of drug product (Grother, Specification, paragraph [0268]). Homogenization is clearly recognized by Grother as a result-effective variable for Zydis wafers.
The Applicant argues that the additional cited references fail to cure the above deficiencies (Remarks, p. 15-17). These arguments were fully considered but are not persuasive because the above deficiencies were addressed.
Furthermore, Otsuka teaches fast orally dissolving composition of aripiprazole using the Zydis system (Otsuka, Abstract). Aripirazole is an insoluble drug substance. Otsuka teaches that Aripirazole Zydis wafers can be prepared in substantially the same way as in the instant way as in the instant invention. Otsuka teaches that Aripiprazole Zydis wafers can be prepared by adding gelatin and mannitol to pure water, mixing and then cooling the mixture, adding the API and homogenizing the mixture at 23 °C:
A rapidly dissolving oral pharmaceutical composition containing aripiprazole was prepared as follows.
Gelatin and mannitol were added to pure water in a mixing vessel, which was then heated to about 60 ° C. with mixing. Mixing was continued in vacuo until the gelatin was completely dissolved. The mixture was cooled.After cooling, aripiprazole, anhydrous citric acid and aspartame were added to the mixture. This mixing was continued until the soluble components were dissolved and the drug particles were completely dispersed and homogenized at room temperature (about 23 °C.).
Table 1 shows the ratio of each component.
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(Table 1 translated with google translate image translator)
The resulting suspension was divided into blister pockets, frozen and lyophilized to complete the dosage form.
The disintegration test was conducted using the current Japanese Pharmacopoeia general test method Disintegration test method (1) immediate release preparation. Water was used as the test solution, and no auxiliary panel was used.
For each of the six tests, the disintegration time was recorded in seconds.
Results of disintegration test: 0 to 4 seconds.
Otsuka, Specification, Translation, p. 2-3 (cited in the prior office action).
Given the above teachings, it is clearly well within the level of ordinary skill in the art to prepare a CBD Zydis wafer and to administer them to the oral cavity of the patient where they rapidly disintegrate for uptake of the API by the mucous membranes of the patient.
Reiterated Rejection
Claim(s) 1, 3-10, 16-22 and 28-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fleury-Teixeira et al. (Front. Neurol., 30 October 2019, Sec. Neuropharmacology, Volume 10, No. 1145, p. 1-8) in view of “Catalent to Partner with Ethicann on New Fast-Dissolve Cannabinoid-Based Treatment for Multiple Sclerosis Spasticity” (Catalent, Dec 03, 2019, p. 1-4) (herein “Catalent”) and Grother et al. (US 20230364013 A1; published Nov. 16, 2023; effectively filed Oct. 8, 2020).
Claim 1 is directed towards a method of treating symptoms of autism spectrum disorder in a subject, comprising: administering to the subject in need thereof, via the oral mucosa, a rapidly infusing composition comprising (a) a pharmaceutically acceptable binder and/or excipient system comprising gelatin and a sugar alcohol, and (b) a therapeutically effective amount of cannabidiol (CBD) or a derivative/analog thereof.
Fleury-Teixeira teaches cannabidiol for the treatment of autism spectrum disorder and its associated symptoms:
Autism Spectrum Disorders comprise conditions that may affect cognitive development, motor skills, social interaction, communication, and behavior. This set of functional deficits often results in lack of independence for the diagnosed individuals, and severe distress for patients, families, and caregivers. There is a mounting body of evidence indicating the effectiveness of pure cannabidiol (CBD) and CBD-enriched Cannabis sativa extract (CE) for the treatment of autistic symptoms in refractory epilepsy patients. There is also increasing data support for the hypothesis that non-epileptic autism shares underlying etiological mechanisms with epilepsy. Here we report an observational study with a cohort of 18 autistic patients undergoing treatment with compassionate use of standardized CBD-enriched CE (with a CBD to THC ratio of 75/1). Among the 15 patients who adhered to the treatment (10 non-epileptic and five epileptic) only one patient showed lack of improvement in autistic symptoms. Due to adverse effects, three patients discontinued CE use before 1 month. After 6–9 months of treatment, most patients, including epileptic and non-epileptic, showed some level of improvement in more than one of the eight symptom categories evaluated: Attention Deficit/Hyperactivity Disorder; Behavioral Disorders; Motor Deficits; Autonomy Deficits; Communication and Social Interaction Deficits; Cognitive Deficits; Sleep Disorders and Seizures, with very infrequent and mild adverse effects. The strongest improvements were reported for Seizures, Attention Deficit/Hyperactivity Disorder, Sleep Disorders, and Communication and Social Interaction Deficits
Fleury-Teixeira, Abstract.
Fleury-Teixeira teaches that the CBD was administered orally in capsules containing 25 or 50 mg of CBD and ∼0.34 or 0.68 mg of THC, respectively (col. 2, p. 3).
While Fleury-Teixeira does not specifically teach a rapidly infusing composition administered via the oral mucosa comprising gelatin, sugar alcohol, and a therapeutically effective amount of CBD, one of ordinary skill in the art would have a reasonable expectation of success to apply such a composition for the treatment of COVID-19 because rapidly infusing compositions comprising CBD, gelatin and sugar alcohol are commonly known in the art.
For example, Catalent teaches that Ethicann Pharmaceuticals Inc. and Catalent are “using Catalent's proven Zydis® orally disintegrating tablet technology to develop a new combination pharmaceutical-grade cannabidiol (CBD) and tetrahydrocannabinol (THC) product.” (Catalent, p. 1). It is well known that the Zydis technology is an orally disintegrating tablet (ODT) technology for delivery via the oral mucosa that comprises mannitol, gelatin and active pharmaceutical ingredient (API) which are freeze dried and compressed to yield a dissolvable wafer.
For example, Grother teaches Zydis Epinephrine, a freeze dried oral dispersible or disintegrating solid dosage form (Grother, Specification, ¶ 0096), comprising solid epinephrine, 10-40 wt.% of a matrix former and 10-40 wt.% of a structure former wherein the matrix former comprises gelatin and the structure former comprises mannitol (¶ 0010). Grother teaches that the dosage form is placed in the oral cavity, such as under the tongue or in the buccal region (¶ 0011) and rapidly dissolves to allow sublingual absorption (¶ 0100). The Zydis technology involves a lyophilized (freeze-dried) composition (Grother, Specification, ¶ 0002).
Therefore, claim 1 was prima facie obvious at the time of filing.
Claim 3 is directed towards the method of claim 1, wherein the rapidly infusing composition has a disintegration time of approximately 1 to 30 seconds in deionized water maintained at 37°C. Claim 4 is directed towards the method of claim 1, wherein the rapidly infusing composition has a disintegration time of approximately 1 to 5 seconds in deionized water maintained at 37°C.
One of ordinary skill in the art would have a reasonable expectation that the CBD Zydis wafer would disintegrate in 1 to 30 seconds or 1 to 5 seconds in 37°C water because it is commonly known in the art that Zydis tablets can disperse in seconds. For example, Grother teaches that Epinephrine Zydis wafers can disperse in less than 7 seconds (fish gelatin) and less than 2 seconds (bovine gelatin) in 20°C water (Grother, Specification, ¶ 0164). Therefore, claims 3-4 were prima facie obvious at the time of filing.
Claim 5 is directed towards the method of claim 1, wherein the gelatin is present in the rapidly infusing composition in an amount of 10 to 35 wt.%, based on a total weight of the rapidly infusing composition on a dry basis. Claim 8 is directed towards the method of claim 1, wherein the sugar alcohol is present in the rapidly infusing composition in an amount of 5 to 35 wt.%, based on a total weight of the rapidly infusing composition on a dry basis.
One of ordinary skill in the art would have a reasonable expectation of success to include the gelatin in an amount of 10 to 35 wt% and mannitol in an amount of 5 to 35 wt% because it is commonly known in the art to include gelatin in Zydis wafers in an amount of about 10 to 35 wt% and mannitol in an amount of 5 to 35 wt%.
For example, Grother teaches Zydis Epinephrine dosage form comprising epinephrine, 10-40 wt.% of a matrix former and 10-40 wt.% of a structure former wherein the matrix former comprises gelatin and the structure former comprises mannitol (Grother, Specification, ¶ 0010). In the specific examples, gelatin and mannitol are the only matrix formers and structure formers used (¶ 0147-0179). Grother teaches a specific example wherein the wafer consists of 4% w/w bovine gelatin, 3% w/w mannitol and 4% epinephrine prior to lyophilization (¶ 0160, Table 1), which would be about but less than 36% gelatin, about but less than less than 27% mannitol and about but less than less than 36% epinephrine after freeze drying to remove the water because there is also an undisclosed but small amount of citric acid which was used for pH adjustment (The pH modifier is present in an amount of 1-10 wt.% , about 1-5 wt.%, about 1-3 wt.%, about 2-3 wt.%, or about 2.51-2.57 wt.% (¶ 120)). Because the prior art ranges closely overlap the claimed ranges and the specific examples are so close to the claimed ranges, a prima facie case of obviousness exists (MPEP § 2144.05).
Therefore, claims 5 and 8 were prima facie obvious at the time of filing.
Claims 6-7 are directed towards the method of claim 1, wherein the gelatin is mammalian gelatin or bovine gelatin, respectively. As shown in the rejection of claim 5, Grother teaches bovine gelatin.
Therefore, claims 6-7 were prima facie obvious at the time of filing.
Claim 9 is directed towards the method of claim 1, wherein the sugar alcohol comprises mannitol. As shown in the rejection of claim 8, Grother teaches mannitol.
Therefore, claim 9 was prima facie obvious at the time of filing.
Claim 10 is directed towards the method of claim 1, wherein the CBD is present in the rapidly infusing composition in an amount of 20 to 70 wt.%, based on a total weight of the rapidly infusing composition on a dry basis.
One of ordinary skill in the art would have a reasonable expectation of success to include the CBD in an amount of 20 to 70 wt.% because it is commonly known in the art to formulate Zydis wafers with similar amounts of active ingredient.
For example, Grother teaches, “the dosage form (i.e., post lyophilization) can include about 10-75 wt.%, about 10-70 wt.%, about 15-70 wt.%, about 20-65 wt.%, about 25-65 wt.%, or about 26.03-60.86 wt.% API (e.g., epinephrine)” (Grother, Specification, ¶ 0145). Fleury-Teixeira teaches a very small amount of THC in the composition as compared to CBD (75:1 ratio; 25 or 50 mg of CBD and ∼0.34 or 0.68 mg of THC (Fleury- Teixeira, col. 2, p. 3)), so an insignificant percentage the API could be present as THC. These ranges are overlap or lie within the claimed range of 20 to 70% so a prima facie case of obviousness exists (MPEP § 2144.05).
Therefore, claim 10 was prima facie obvious at the time of filing.
Claim 16 is directed towards the method of claim 1, wherein the rapidly infusing composition further comprises at least one selected from the group consisting of a sweetener, a flavorant, and a colorant. Claim 17 is directed towards the method of claim 16, wherein the rapidly infusing composition comprises the flavorant, and the flavorant comprises lemon-lime flavor. Claim 18 is directed towards the method of claim 16, wherein the rapidly infusing composition comprises the colorant, and the colorant comprises FD&C Yellow #5. Claim 19 is directed towards the method of claim 16, wherein the rapidly infusing composition comprises the sweetener, and the sweetener comprises a mixture of sucralose and acesulfame-K.
One of ordinary skill in the art would have a reasonable expectation of success to further include a sweetener, a flavorant, and a colorant for example lemon-lime flavor, FD&C yellow #5 and sucralose and acesulfame K because it is commonly known in the art to include such sweeteners, flavorants, and colorants in orodispersable compositions.
For example, Grother teaches that the formulation can also include “coloring agents, flavoring agents, pH modifiers, sweeteners, taste-masking agents, and combinations thereof.” (Grother, Specification, ¶ 0102). Grother teaches suitable coloring agents include “red, black and yellow iron oxides and FD & C dyes” and flavoring agents include citrus such as orange, lemon, grapefruit (id.). Suitable sweeteners include sucralose and acesulfame K (Grother, Specification, ¶ 0103).
Therefore, claims 16-19 were prima facie obvious at the time of filing.
Claim 20 is directed towards the method of claim 1, wherein the rapidly infusing composition is administered to the subject via the buccal mucosa.
One of ordinary skill in the art would have a reasonable expectation of success to administer the composition to the subject via the buccal mucosa because it is commonly known in the art to administer ODTs via the buccal mucosa. For example, Grother teaches to administer the dosage form via the buccal region (Grother, Specification, ¶ 0011).
Therefore, claim 20 was prima facie obvious at the time of filing.
Claim 21 is directed towards the method of claim 1, wherein the therapeutically effective amount of CBD or derivative/analog thereof is from 0.1 mg/kg/day to less than 5 mg/kg/day.
One of ordinary skill in the art would have a reasonable expectation of success that the therapeutically effective amount of CBD is from 0.1 mg/kg/day to less than 5 mg/kg/day because Fleury-Teixeira teaches that the average therapeutically effective dose was 4.55 mg/kg/day (col. 2, p. 3).
Therefore, claim 21 was prima facie obvious at the time of filing.
Claim 22 is directed towards the method of claim 1, wherein the rapidly infusing composition is administered to the subject 1 to 3 times per day.
One of ordinary skill in the art would have a reasonable expectation of success to administer the composition 1 to 3 times per days because Fleury-Teixeira teaches to administer the composition twice daily in the morning and evening (Table 1, col. 1, p. 3).
Therefore, claim 22 was prima facie obvious at the time of filing.
Claim 28 is directed towards the method of claim 1, wherein the subject presents with at least one symptom selected from the group consisting of stereotypic behavior, underdeveloped motor skills, atypical nonverbal behaviors, self-injurious behavior (SIB), restlessness, hyperactivity, sleep deprivation, lethargy, anxiety, psychosis, seizures, disruptive behaviors, irritability or severe mood dysregulation, aggression, agitation, challenges with social interaction, impaired communication, noncompliance, resistance to change in routine, and unusual sensory reactivity.
One of ordinary skill in the art would have a reasonable expectation of success to treat a patient presenting with these symptoms because Fleury-Teixeira teaches cannabidiol for the treatment of autism spectrum disorder and its associated symptoms including Attention Deficit/Hyperactivity Disorder; Behavioral Disorders (ADHD); Motor Deficits (MD); Autonomy Deficits (AS); Communication and Social Interaction Deficits (CSID); Cognitive Deficits (CD); Sleep Disorders (SD) and Seizures (SZ) (Fleury-Teixeira, Abstract, Table 2, Fig. 1). Furthermore, Fleury-Teixeira teaches significant improvements in these categories:
At least 60% of patients showed improvements of 20% or more in ADHD, MD, CSID, BD, SD, and SZ. From the 15 patients who presented BD, eight (53.3%) had improvements equal to or above 20% in this symptom category. In AD, only four (26.7%) had improvements equal to or above 20%. The most robust results were found for ADHD, SD, and SZ, with more than 80% of patients presenting improvements equal to or above 30%.
Fleury-Teixeira, col. 2, p. 5.
Therefore, claim 28 was prima facie obvious at the time of filing.
Claim 29 is directed towards the method of claim 1, wherein the subject is comorbid with both ASD and epilepsy.
One of ordinary skill in the art would have a reasonable expectation of success to treat patients comorbid with both ASD and epilepsy because Fleury-Teixeira teaches to treat patients comorbid with both ASD and epilepsy:
Among the 15 patients who remained in the study, 05 had a diagnosis of epilepsy and had had seizures in the month preceding CE treatment, while the remaining 10 had never been diagnosed with epilepsy or had not had any clinical seizures for more than 12 months before treatment with CE. Among the five epileptic patients, one was diagnosed with Dravet’s syndrome, two had epilepsy associated with cerebral palsy, and two had refractory epilepsy of undetermined etiology.
Fleury-Teixeira, col. 1, p. 3;
The results were particularly impressive 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.
Fleury-Teixeira, col. 2, p. 5.
Therefore, claim 29 was prima facie obvious at the time of filing.
Claim 30 is directed towards the method of claim 29, wherein the epilepsy is one or more of childhood epilepsy, drug resistant epilepsy, and epilepsy that presents with atonic seizures.
As shown in the rejection of claim 29, Fleury-Teixeira teaches that the patients had Dravet syndrome (childhood epilepsy) and refractory epilepsy (drug resistant epilepsy).
Therefore, claim 30 was prima facie obvious at the time of filing.
Claim 31 is directed towards method of claim 29, wherein a total convulsive frequency of the subject is reduced by at least 50%, relative to the total convulsive frequency observed prior to administration of the rapidly infusing composition. Claim 32 is directed towards the method of claim 29, wherein a total convulsive frequency of the subject is reduced by at least 70%, relative to the total convulsive frequency observed prior to administration of the rapidly infusing composition.
One of ordinary skill in the art would have a reasonable expectation of success to reduce seizure frequency by at least 50% or 70% because as shown in the rejection of claim 29, Fleury-Teixeira teaches that there was a seizure reduction of 50% in three cases and 100% in the other two cases.
Therefore, claims 31-32 were prima facie obvious at the time of filing.
Claim 33 is directed towards the method of claim 1, wherein the rapidly infusing composition is administered in combination with a second therapeutic agent. Claim 34 is directed towards the method of claim 33, wherein the second therapeutic agent is an antidepressant, an anxiolytic, an antipsychotic, a stimulant, a cognition-enhancing medication, or an antiepileptic drug.
One of ordinary skill in the art would have a reasonable expectation of success to administer the rapidly infusing composition in combination with a second therapeutic agent wherein the second therapeutic agent is an antidepressant, an anxiolytic, an antipsychotic, a stimulant, a cognition-enhancing medication, or an antiepileptic drug because Fleury-Teixeira teaches that some patients were administered a second neuropsychiatric agent with CBD:
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Fleury-Teixeira, Table 3, p. 6.
Therefore, claims 33-34 were prima facie obvious at the time of filing.
Claim(s) 1,3-10, 12-13, 16-22 and 28-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fleury-Teixeira et al. (Front. Neurol., 30 October 2019, Sec. Neuropharmacology, Volume 10, No. 1145, p. 1-8), “Catalent to Partner with Ethicann on New Fast-Dissolve Cannabinoid-Based Treatment for Multiple Sclerosis Spasticity” (Catalent, Dec 03, 2019, p. 1-4) (herein “Catalent”) and Grother et al. (US 2023/0364013 A1; published Nov. 16, 2023; effectively filed Oct. 8, 2020), as applied to claims 1-10, 16-22 and 28-34 above, and further in view of Marco (CBD Mania, Jan. 26, 2021, pp. 1-16).
The rejection of claims 1-10, 16-22 and 28-34 as obvious over Fleury-Teixeira, Catalent and Grother is incorporated herein by reference.
Claim 12 is directed towards the method of claim 1, wherein the rapidly infusing composition is formulated with a solid form of the CBD having a purity between 95 and 99.9 wt.%.
While Fleury-Teixeira does not teach the form of the CBD in the capsules, one of ordinary skill in the art would have a reasonable expectation of success to formulate the CBD ODTs with the solid form of CBD because it is commonly known in the art to formulate ODTs with crystalline APIs and crystalline CBD is commonly known in the art.
For example, Grother teaches to use crystalline epinephrine in the ODTs because it is stable (Grother, Specification, ¶ 0009). For example, Marco teaches crystalline CBD, a highly pure cannabidiol extract, which can be taken by a sublingual route (Marco, p. 3-5). For example, Marco teaches:
CBD crystals are becoming increasingly popular due to their versatility, which leaves plenty of room for customisation when it comes to how they are taken. The main advantages of this type of cannabis derivative include the ability to easily mix the active ingredient into drinks or edible preparations, to apply it topically or to take it simply under the tongue, for example, just like CBD oil.
Marco, p. 4.
One of ordinary skill in the art would have a reasonable expectation of success to formulate the composition with CBD having a purity between 95 and 99.9 wt.% because Marco teaches that CBD crystals have a purity level of around 99%: “CBD crystals are a pure cannabidiol extract with a purity level of around 99% “(Marco, p. 3).
Therefore, claim 12 was prima facie obvious at the time of filing.
Claim 13 is directed towards The method of claim 1, wherein the rapidly infusing composition is formulated with a solid form of the CBD that has been micronized to have a D50 diameter between 1 and 50 µm.
One of ordinary skill in the art would have a reasonable expectation of success to formulate the composition with a solid form of the CBD that has been micronized to have a D50 diameter between 1 and 50 µm because Grother teaches to micronize the API to a diameter of about 10-40 microns (Grother, Specification, ¶ 0123), and teaches examples with a D50 of e.g. 38.024 microns and 21.495 microns (batch 3, Fig. 76).
Therefore, claim 13 was prima facie obvious at the time of filing.
Claim(s) 1, 3-10, 14-22 and 28-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fleury-Teixeira et al. (Front. Neurol., 30 October 2019, Sec. Neuropharmacology, Volume 10, No. 1145, p. 1-8), “Catalent to Partner with Ethicann on New Fast-Dissolve Cannabinoid-Based Treatment for Multiple Sclerosis Spasticity” (Catalent, Dec 03, 2019, p. 1-4) (herein “Catalent”) and Grother et al. (US 2023/0364013 A1; published Nov. 16, 2023; effectively filed Oct. 8, 2020), as applied to claims 1-10, 16-22 and 28-34 above, and further in view of Rock et al. (Psychopharmacology, vol. 237, pages 2621–2631, (2020), published 02 June 2020).
The rejection of claims 1-10, 16-22 and 28-34 as obvious over Fleury-Teixeira, Catalent and Grother is incorporated herein by reference.
Claim 14 is directed towards the method of claim 1, wherein the rapidly infusing composition is formulated with a CBD derivative/analog. Claim 15 is directed towards the method of claim 14, wherein the CBD derivative/analog is cannabidiolic acid methyl ester.
While Fleury-Teixeira does not teach a CBD derivative/ analog such as cannabidiolic acid methyl ester, one of ordinary skill in the art would have a reasonable expectation of success to include a CBD derivative/ analog as the form of CBD because it is commonly known in the art that CBD derivative/ analogs such as cannabidiolic acid methyl ester are structurally related to CBD and have similar properties.
For example, Rock teaches that cannabidiolic acid methyl ester is structurally related to CBD and produces similar effects at the 5-HT1A receptor:
When acutely administered intraperitoneally, the non-psychoactive cannabinoid cannabidiol (CBD), its acidic precursor cannabidiolic acid (CBDA) and a stable methyl ester of CBDA (HU-580) reduce lithium chloride (LiCl)–induced conditioned gaping in male rats (a selective preclinical model of acute nausea) via activation of the serotonin 1A (5-HT1A) receptor…
Both acute and repeated (7 day) s.c. administrations of CBD (5 mg/kg), CBDA (1 μg/kg) and HU-580 (1 μg/kg) similarly reduced LiCl-induced conditioned gaping, and these effects were blocked by 5HT1A receptor antagonism. When administered over 4 weekly conditioning trials, the anti-nausea effectiveness of each of these compounds was also maintained. Repeated CBD (5 mg/kg, s.c.) maintained its anti-emetic efficacy in S. murinus. Acute CBD (5 and 20 mg/kg, s.c.) administration reduced LiCl-induced conditioned gaping similarly in male and female rats.
Rock, Abstract.
Therefore, claims 14-15 were prima facie obvious at the time of filing.
Claim(s) 1, 3-10 and 16-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fleury-Teixeira et al. (Front. Neurol., 30 October 2019, Sec. Neuropharmacology, Volume 10, No. 1145, p. 1-8), “Catalent to Partner with Ethicann on New Fast-Dissolve Cannabinoid-Based Treatment for Multiple Sclerosis Spasticity” (Catalent, Dec 03, 2019, p. 1-4) (herein “Catalent”) and Grother et al. (US 2023/0364013 A1; published Nov. 16, 2023; effectively filed Oct. 8, 2020), as applied to claims 1-10, 16-22 and 28-34 above, and further in view of Kikuchi et al. (US9017737B2, published April 28, 2015), Hobbs et al. (Drugs in R&D, Volume 13, pages 281–288, (2013), Published: 30 October 2013) and Grother et al. (JP2012121850A; published June 28, 2012) (herein “Otsuka”) citing to “Catalent Announces Commencement of Supply of Abilify® Orally Disintegrating Tablets to Otsuka Pharmaceutical Co. Ltd. and Extensive Investments to its Zydis® to Technology Capabilities in Swindon, UK” (American Pharmaceutical Review, July 25, 2012, p. 1-5) (herein “American Pharmaceutical Review”).
The rejection of claims 1-10, 16-22 and 28-34 as obvious over Fleury-Teixeira, Catalent and Grother is incorporated herein by reference.
Claim 23 is directed towards the method of claim 1, wherein the rapidly infusing composition further comprises a therapeutically effective amount of an antipsychotic agent.
As shown in the rejection of claims 33-34, Fleury-Teixeira teaches that CBD was administered in combination with an additional therapeutic agent such as the antipsychotic risperidone (Fleury-Teixeira, Table 3, p. 6). While Fleury-Teixeira does not teach that the antipsychotic is formulated in a single orally disintegrating dosage form comprising the CBD, antipsychotic, gelatin and mannitol, one of ordinary skill in the art would have reasonable expectation of success to formulate an orally disintegrating dosage form comprising the CBD, antipsychotic, gelatin and mannitol because it is commonly known in the art to combine CBD and antipsychotics in a single dosage unit for the treatment of neuropsychiatric conditions and it is commonly known to formulate antipsychotics as orally disintegrating tablets using the Zydis technology.
For example, Kikuchi teaches pharmaceutical compositions comprising cannabinoids such as CBD in combination with antipsychotics such as risperidone and aripiprazole:
The invention also encompasses pharmaceutical compositions comprising cannabinoids, or pharmaceutically acceptable salts or derivatives thereof in combination with anti-psychotic medicaments, formulated into pharmaceutical dosage forms, together with suitable pharmaceutically acceptable carriers, such as diluents, fillers, salts, buffers, stabilizers, solubilizers, etc. The dosage form may contain other pharmaceutically acceptable excipients for modifying conditions such as pH, osmolarity, taste, viscosity, sterility, lipophilicity, solubility etc. The choice of diluents, carriers or excipients will depend on the desired dosage form, which may in turn be dependent on the intended route of administration to a patient.
Suitable dosage forms include, but are not limited to, solid dosage forms, for example tablets, capsules, powders, dispersible granules, cachets and suppositories, including sustained release and delayed release formulations.
Kikuchi, col. 7, lines 5-21 (emphasis added);
Preferably the one or more anti-psychotic medicaments are atypical anti-psychotic medicaments.
More preferably the atypical anti-psychotic medicament is taken from the group: aripiprazole; risperidone; paliperidone; ziprasidone; olanzapine; quetiapine; clozapine; sulpiride; amisulpride; iloperidone; cariprazine; asenapine.
More preferably the atypical anti-psychotic medicament is aripiprazole…
Kikuchi, col. 7, lines 52-58 (emphasis added);
By comparison of FIG. 6 a with FIG. 6 b it is apparent that CBD (120 mg/kg, ip) significantly decreased Aripiprazole-induced catalepsy in rats (total, p=0.0286; 8 hr, p=0.0339, by generalized estimating equations). i.e. a combination effect was detected.
From FIG. 7 it is apparent that CBD (120 mg/kg, ip) significantly decreased Aripiprazole-induced ptosis in rats (Drug (CBD), p<0.01; Interaction, p<0.01, by 2-way ANOVA). i.e. a combination effect was detected.
Kikuchi, col. 19, lines 27-31; 50-54.
For example, Hobbs teaches Olanzapine Zydis ODT, which was vastly superior other available antipsychotic ODTs in terms of disintegration time:
The ODT manufacturing method was associated with time to disintegrate; the fastest were freeze dried tablets, followed by soft compressed tablets and then hard/dense tablets. Olanzapine Zydis® was the only ODT that completely disintegrated in less than 4 s for all strengths (5, 10, 15, and 20 mg), followed by 5-mg Prolanz FAST® (12 s) and then risperidone ODT 4 mg (40 s).
Hobbs, Abstract.
For example, Otsuka teaches an orally disintegrating tablet comprising aripiprazole, gelatin and mannitol for the treatment of autism (indications listed on page 2 of the translated specification):
The present invention relates to a pharmaceutical composition for oral administration in the form of a rapid dispersion dosage form comprising aripiprazole as an active ingredient.
Otsuka, Specification, Translation, p. 1;
[S]uch compositions are particularly useful in the treatment of pediatric and elderly patients who dislike such compositions or are difficult to swallow or in the administration of conventional tablets, pills or capsules. If it is not possible, it will have drawbacks. One way to overcome this problem is to administer a solid dosage form that disintegrates rapidly in the oral cavity.
In order to solve such a problem, the present inventors have intensively studied to arrive at the following invention. That is, the present invention is as follows.
(1) A pharmaceutical composition for oral administration comprising aripiprazole as an active ingredient and a carrier, rapidly disintegrating within 10 seconds in contact with a fluid and rapidly releasing the active ingredient. The above-mentioned pharmaceutical composition for oral administration which is in the form of a dispersion dosage form.
(2) The pharmaceutical composition according to (1) above, wherein the carrier is gelatin.
(3) Additional ingredients selected from the group consisting of matrix forming agents, sugars, cyclic sugars, amino acids, preservatives, surfactants, viscosity enhancers, colorants, seasonings, pH adjusters, sweeteners and combinations thereof.
Otsuka, Specification, Translation, p. 2;
The present invention will be described in more detail with reference to the following examples…
A rapidly dissolving oral pharmaceutical composition containing aripiprazole was prepared as follows.
Gelatin and mannitol were added to pure water in a mixing vessel, which was then heated to about 60 ° C. with mixing. Mixing was continued in vacuo until the gelatin was completely dissolved. The mixture was cooled.After cooling, aripiprazole, anhydrous citric acid and aspartame were added to the mixture. This mixing was continued until the soluble components were dissolved and the drug particles were completely dispersed and homogenized at room temperature (about 23 °C.).
Table 1 shows the ratio of each component.
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(Table 1 translated with google translate image translator)
The resulting suspension was divided into blister pockets, frozen and lyophilized to complete the dosage form.
The disintegration test was conducted using the current Japanese Pharmacopoeia general test method Disintegration test method (1) immediate release preparation. Water was used as the test solution, and no auxiliary panel was used.
For each of the six tests, the disintegration time was recorded in seconds.
Results of disintegration test: 0 to 4 seconds.
Otsuka, Specification, Translation, p. 2-3.
Otsuka discloses the Zydis technology as Otsuka is also authored by Grother and Otsuka Pharmaceuticals had an agreement with Catalent to sell Abilify ODT (Abilify is the brand name of Aripiprazole) made using Zydis technology as shown by American Pharmaceutical Review on pages 2-3. After the water is removed by lyophilization, the example as in Table 1 would contain:
Aripiprazole- 27%- 36%
Gelatin - 36-41%
Mannitol- 24-27%
Citric acid- 1.2-1.4%
Aspartame- 2.4-2.7%.
This is very similar to the Epinephrine Zydis taught by Grother.
It clearly well within the level of ordinary skill to combine two substances known to be compatible with Zydis technology, CBD and an antipsychotic such as aripiprazole, to make a combined ODT preparation of these two substances, particularly given that it is well known to combine these substances as demonstrated by Kikuchi.
Therefore, claim 23 was prima facie obvious at the time of filing.
Claim 26 is directed towards the method of claim 23, wherein the antipsychotic agent is aripiprazole. Claim 27 is directed towards the method of claim 26, wherein the therapeutically effective amount of aripiprazole is from 1 mg to 30 mg per day.
The rejection of claim 23 is incorporated herein by reference. As such, it was prima facie obvious to combine aripiprazole with CBD in a ODT dosage unit for the treatment of autism. Furthermore, one of ordinary skill in the art would have a reasonable expectation of success to administer 1 mg to 30 mg of aripiprazole per day because this is a commonly known therapeutically effective dosage. For example, Otsuka teaches that the dosage unit most preferably contains 3 mg to 24 mg of aripiprazole (Otsuka, Specification, translation, p. 2).
Therefore, claims 26-27 were prima facie obvious at the time of filing.
Claim 24 is directed towards the method of claim 23, wherein the antipsychotic agent is risperidone.
As shown in the rejection of claims 33-34, Fleury-Teixeira teaches that CBD was administered in combination with an additional therapeutic agent such as the antipsychotic risperidone (Fleury-Teixeira, Table 3, p. 6).
While Fleury-Teixeira does not teach that the antipsychotic is formulated in a single orally disintegrating dosage form comprising the CBD, risperidone, gelatin and mannitol, one of ordinary skill in the art would have reasonable expectation of success to formulate an orally disintegrating dosage form comprising the CBD, risperidone, gelatin and mannitol because it is commonly known in the art to combine CBD and risperidone in a single dosage unit for the treatment of neuropsychiatric conditions and it is commonly known to formulate antipsychotics as orally disintegrating tablets using the Zydis technology.
For example, as shown in the rejection of claim 23, Kikuchi teaches a pharmaceutical formulation comprising risperidone in combination with a cannabinoid such as CBD.
For example, as shown in the rejection of claim 23, Otsuka teaches an orally disintegrating tablet comprising aripiprazole made using the Zydis technology.
For example, Hobbs teaches that the antipsychotics olanzapine and risperidone are available as orally disintegrating tablets (Hobbs, Abstract). Hobbs teaches that “Olanzapine Zydis® (also known as Velotab®) is manufactured by Catalent Pharma Solutions (Somerset, NJ, USA), and is made by a freeze drying process that provides a low-density, highly porous structure that readily disintegrates in the oral cavity.” (Hobbs, col. 1, p. 282). Hobbs teaches that olanzapine Zydis comprises mannitol, aspartame, gelatin, preservatives, similar to the Abilify ODT taught by Otsuka, and that Olanzapine Zydis outperforms other antipsychotic orally disintegrating tablets:
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Hobbs, p. 285.
Given the superior properties of the Zydis technology for antipsychotic orally disintegrating tablets, it would be obvious to also include risperidone in an orally disintegrating tablet using the Zydis technology which comprises gelatin, CBD and mannitol.
Therefore, claim 24 was prima facie obvious at the time of filing.
Claim 25 is directed towards the method of claim 24, wherein the therapeutically effective amount of risperidone is from 0.25 mg to 20 mg per day.
While Fleury-Teixeira does not teach the therapeutically effective amount of risperidone, one of ordinary skill in the art would have a reasonable expectation of success to use 0.25 mg to 20 mg per day as the therapeutically effective amount of risperidone because these doses are commonly known in the art. For example, Hobbs teaches that Risperdal M-Tab is available in 2 mg and 4 mg doses (Hobbs, Table 4, p. 285).
Therefore, claim 25 was prima facie obvious at the time of filing.
Given the above teachings, the invention as a whole was prima facie obvious at the time of filing.
Nonstatutory Double Patenting – Previously Presented
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.
Response to Arguments
The Applicant argues that they filed eTerminal Disclaimers to obviate the nonstatutory double patenting rejections and provisional nonstatutory double patenting rejections (Remarks, p. 18). These arguments were fully considered but are not persuasive. No eTerminal Disclaimers are present in the Application file or the corresponding Application files.
Reiterated Rejection
Claim(s) 1-13, 16-22 and 28-34 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-24 and 31-32 of copending Application No. 18/307,228 in view of Fleury-Teixeira et al. (Front. Neurol., 30 October 2019, Sec. Neuropharmacology, Volume 10, No. 1145, p. 1-8).
Although the claims at issue are not identical, they are not patentably distinct because claims 21-24 and 31-32 of the copending application are directed towards the composition as in claims 1-13 and 16-19 of the instant application and Fleury-Teixeira teaches to apply cannabinoid compositions for the treatment of autism spectrum disorder as in the instant application as explained in the 103 rejection of these claims above, incorporated herein by reference.
This is a provisional nonstatutory double patenting rejection.
Claim(s) 1-22 and 28-34 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-24 and 31-32 of copending Application No. 18/307,228 in view of Fleury-Teixeira et al. (Front. Neurol., 30 October 2019, Sec. Neuropharmacology, Volume 10, No. 1145, p. 1-8) and Rock et al. (Psychopharmacology, vol. 237, pages 2621–2631, (2020), published 02 June 2020).
Although the claims at issue are not identical, they are not patentably distinct because claims 21-24 and 31-32 of the copending application are directed towards the composition as in claims 1-13 and 16-19 of the instant application and Fleury-Teixeira teaches to apply cannabinoid compositions for the treatment of autism spectrum disorder as in the instant application as explained in the 103 rejection of these claims above, incorporated herein by reference. Claims 15-16 additionally recite that the CBD is a CBD analog or derivative, but it would be prima facie obvious to substitute CBD for a CBD analog or derivative as shown by the teachings of Rock above, incorporated herein by reference.
This is a provisional nonstatutory double patenting rejection.
Claim(s) 1-13 and 16-34 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-24 and 31-32 of copending Application No. 18/307,228 in view of Fleury-Teixeira et al. (Front. Neurol., 30 October 2019, Sec. Neuropharmacology, Volume 10, No. 1145, p. 1-8), Kikuchi et al. (US9017737B2, published April 28, 2015), Hobbs et al. (Drugs in R&D, Volume 13, pages 281–288, (2013), Published: 30 October 2013) and Grother et al. (JP2012121850A; published June 28, 2012) (herein “Otsuka”) citing to “Catalent Announces Commencement of Supply of Abilify® Orally Disintegrating Tablets to Otsuka Pharmaceutical Co. Ltd. and Extensive Investments to its Zydis® to Technology Capabilities in Swindon, UK” (American Pharmaceutical Review, July 25, 2012, p. 1-5) (herein “American Pharmaceutical Review”).
Although the claims at issue are not identical, they are not patentably distinct because claims 21-24 and 31-32 of the copending application are directed towards the composition as in claims 1-13 and 16-19 of the instant application and Fleury-Teixeira teaches to apply cannabinoid compositions for the treatment of autism spectrum disorder as in the instant application as explained in the 103 rejection of these claims above, incorporated herein by reference. Claims 23-27 additionally recite that the composition additionally comprises an antipsychotic such as risperidone or aripiprazole. One of ordinary skill in the art would have a reasonable expectation of success to include an antipsychotic in the composition as demonstrated by Kikuchi, Otsuka, and Hobbs, the rejection above incorporated herein by reference.
This is a provisional nonstatutory double patenting rejection.
Claim(s) 1-13, 16-22 and 28-34 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 11,672,761 B2 (herein the ‘761 patent) in view of Fleury-Teixeira et al. (Front. Neurol., 30 October 2019, Sec. Neuropharmacology, Volume 10, No. 1145, p. 1-8).
Although the claims at issue are not identical, they are not patentably distinct because the instant claims are directed towards a method of treating autism spectrum disorder with an orally dispersible composition comprising cannabidiol, gelatin, and mannitol. The claims of the ‘761 patent are directed towards a method of treating pain in a subject with the same composition. Given that it was well known in the art to apply cannabidiol to the treatment of autism spectrum disorder as shown by Fleury-Teixeira above, the rejection incorporated herein by reference, one of ordinary skill in the art would have a reasonable expectation of success to apply the composition of the ‘761 patent to the treatment of autism spectrum disorder as well.
Therefore, claims 1-13, 16-22 and 28-34 are rejected on the ground of nonstatutory double patenting.
Claim(s) 1-22 and 28-34 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 11,672,761 B2 (herein the ‘761 patent) in view of Fleury-Teixeira et al. (Front. Neurol., 30 October 2019, Sec. Neuropharmacology, Volume 10, No. 1145, p. 1-8), and Rock et al. (Psychopharmacology, vol. 237, pages 2621–2631, (2020), published 02 June 2020).
Although the claims at issue are not identical, they are not patentably distinct because the instant claims are directed towards a method of treating autism spectrum disorder with an orally dispersible composition comprising cannabidiol, gelatin, and mannitol. The claims of the ‘761 patent are directed towards a method of treating pain in a subject with the same composition. Given that it was well known in the art to apply cannabidiol to the treatment of autism spectrum disorder as shown by Fleury-Teixeira above, the rejection incorporated herein by reference, one of ordinary skill in the art would have a reasonable expectation of success to apply the composition of the ‘761 patent to the treatment of autism spectrum disorder as well.
Claims 15-16 additionally recite that the CBD is a CBD analog or derivative, but it would be prima facie obvious to substitute CBD for a CBD analog or derivative as shown by the teachings of Rock above, incorporated herein by reference.
Therefore, claims 1-22 and 28-34 are rejected on the ground of nonstatutory double patenting.
Claim(s) 1-13 and 16-34 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 11,672,761 B2 (herein the ‘761 patent) in view of Fleury-Teixeira et al. (Front. Neurol., 30 October 2019, Sec. Neuropharmacology, Volume 10, No. 1145, p. 1-8), Kikuchi et al. (US9017737B2, published April 28, 2015), Hobbs et al. (Drugs in R&D, Volume 13, pages 281–288, (2013), Published: 30 October 2013) and Grother et al. (JP2012121850A; published June 28, 2012) (herein “Otsuka”) citing to “Catalent Announces Commencement of Supply of Abilify® Orally Disintegrating Tablets to Otsuka Pharmaceutical Co. Ltd. and Extensive Investments to its Zydis® to Technology Capabilities in Swindon, UK” (American Pharmaceutical Review, July 25, 2012, p. 1-5) (herein “American Pharmaceutical Review”).
Although the claims at issue are not identical, they are not patentably distinct because the instant claims are directed towards a method of treating autism spectrum disorder with an orally dispersible composition comprising cannabidiol, gelatin, and mannitol. The claims of the ‘761 patent are directed towards a method of treating pain in a subject with the same composition. Given that it was well known in the art to apply cannabidiol to the treatment of autism spectrum disorder as shown by Fleury-Teixeira above, the rejection incorporated herein by reference, one of ordinary skill in the art would have a reasonable expectation of success to apply the composition of the ‘761 patent to the treatment of autism spectrum disorder as well.
One of ordinary skill in the art would have a reasonable expectation of success to include an antipsychotic in the composition as demonstrated by Kikuchi, Otsuka, and Hobbs, the rejection above incorporated herein by reference.
Therefore, claims 1-13 and 16-34 are rejected on the ground of nonstatutory double patenting.
Claim(s) 1-13, 16-22 and 28-34 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of copending Application No. 18/252,694 in view of Fleury-Teixeira et al. (Front. Neurol., 30 October 2019, Sec. Neuropharmacology, Volume 10, No. 1145, p. 1-8).
Although the claims at issue are not identical, they are not patentably distinct because the instant claims are directed towards a method of treating autism spectrum disorder with an orally dispersible composition comprising cannabidiol, gelatin, and mannitol. The claims of the copending application are directed towards a method of treating Alzheimer’s Disease in a subject with the same composition. Given that it was well known in the art to apply cannabidiol to the treatment of autism spectrum disorder as shown by Fleury-Teixeira above, the rejection incorporated herein by reference, one of ordinary skill in the art would have a reasonable expectation of success to apply the composition of the copending application to the treatment of autism spectrum disorder as well.
This is a provisional nonstatutory double patenting rejection.
Claim(s) 1-22 and 28-34 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of copending Application No. 18/252,694 in view of Fleury-Teixeira et al. (Front. Neurol., 30 October 2019, Sec. Neuropharmacology, Volume 10, No. 1145, p. 1-8) and Rock et al. (Psychopharmacology, vol. 237, pages 2621–2631, (2020), published 02 June 2020).
Although the claims at issue are not identical, they are not patentably distinct because the instant claims are directed towards a method of treating autism spectrum disorder with an orally dispersible composition comprising cannabidiol, gelatin, and mannitol. The claims of the copending application are directed towards a method of treating Alzheimer’s Disease in a subject with the same composition. Given that it was well known in the art to apply cannabidiol to the treatment of autism spectrum disorder as shown by Fleury-Teixeira above, the rejection incorporated herein by reference, one of ordinary skill in the art would have a reasonable expectation of success to apply the composition of the copending application to the treatment of autism spectrum disorder as well.
Claims 15-16 additionally recite that the CBD is a CBD analog or derivative, but it would be prima facie obvious to substitute CBD for a CBD analog or derivative as shown by the teachings of Rock above, incorporated herein by reference.
This is a provisional nonstatutory double patenting rejection.
Claim(s) 1-13 and 16-34 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of copending Application No. 18/252,694 in view of Fleury-Teixeira et al. (Front. Neurol., 30 October 2019, Sec. Neuropharmacology, Volume 10, No. 1145, p. 1-8), Kikuchi et al. (US9017737B2, published April 28, 2015), Hobbs et al. (Drugs in R&D, Volume 13, pages 281–288, (2013), Published: 30 October 2013) and Grother et al. (JP2012121850A; published June 28, 2012) (herein “Otsuka”) citing to “Catalent Announces Commencement of Supply of Abilify® Orally Disintegrating Tablets to Otsuka Pharmaceutical Co. Ltd. and Extensive Investments to its Zydis® to Technology Capabilities in Swindon, UK” (American Pharmaceutical Review, July 25, 2012, p. 1-5) (herein “American Pharmaceutical Review”).
Although the claims at issue are not identical, they are not patentably distinct because the instant claims are directed towards a method of treating autism spectrum disorder with an orally dispersible composition comprising cannabidiol, gelatin, and mannitol. The claims of the copending application are directed towards a method of treating Alzheimer’s Disease in a subject with the same composition. Given that it was well known in the art to apply cannabidiol to the treatment of autism spectrum disorder as shown by Fleury-Teixeira above, the rejection incorporated herein by reference, one of ordinary skill in the art would have a reasonable expectation of success to apply the composition of the copending application to the treatment of autism spectrum disorder as well.
Claims 23-27 additionally recite that the composition additionally comprises an antipsychotic such as risperidone or aripiprazole. One of ordinary skill in the art would have a reasonable expectation of success to include an antipsychotic in the composition as demonstrated by Kikuchi, Otsuka, and Hobbs, the rejection above incorporated herein by reference.
This is a provisional nonstatutory double patenting rejection.
Claim(s) 1-13, 16-22 and 28-34 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-35 of copending Application No. 18/252,693 in view of Fleury-Teixeira et al. (Front. Neurol., 30 October 2019, Sec. Neuropharmacology, Volume 10, No. 1145, p. 1-8).
Although the claims at issue are not identical, they are not patentably distinct because the instant claims are directed towards a method of treating autism spectrum disorder with an orally dispersible composition comprising cannabidiol, gelatin, and mannitol. The claims of the copending application are directed towards a method of treating an autoimmune disease or inflammatory condition in a subject with the same composition. Given that it was well known in the art to apply cannabidiol to the treatment of autism spectrum disorder as shown by Fleury-Teixeira above, the rejection incorporated herein by reference, one of ordinary skill in the art would have a reasonable expectation of success to apply the composition of the copending application to the treatment of autism spectrum disorder as well.
This is a provisional nonstatutory double patenting rejection.
Claim(s) 1-22 and 28-34 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-35 of copending Application No. 18/252,693 in view of Fleury-Teixeira et al. (Front. Neurol., 30 October 2019, Sec. Neuropharmacology, Volume 10, No. 1145, p. 1-8) and Rock et al. (Psychopharmacology, vol. 237, pages 2621–2631, (2020), published 02 June 2020).
Although the claims at issue are not identical, they are not patentably distinct because the instant claims are directed towards a method of treating autism spectrum disorder with an orally dispersible composition comprising cannabidiol, gelatin, and mannitol. The claims of the copending application are directed towards a method of treating an autoimmune disease or inflammatory condition in a subject with the same composition. Given that it was well known in the art to apply cannabidiol to the treatment of autism spectrum disorder as shown by Fleury-Teixeira above, the rejection incorporated herein by reference, one of ordinary skill in the art would have a reasonable expectation of success to apply the composition of the copending application to the treatment of autism spectrum disorder as well.
Claims 15-16 additionally recite that the CBD is a CBD analog or derivative, but it would be prima facie obvious to substitute CBD for a CBD analog or derivative as shown by the teachings of Rock above, incorporated herein by reference.
This is a provisional nonstatutory double patenting rejection.
Claim(s) 1-13 and 16-34 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-35 of copending Application No. 18/252,693 in view of Fleury-Teixeira et al. (Front. Neurol., 30 October 2019, Sec. Neuropharmacology, Volume 10, No. 1145, p. 1-8), Kikuchi et al. (US9017737B2, published April 28, 2015), Hobbs et al. (Drugs in R&D, Volume 13, pages 281–288, (2013), Published: 30 October 2013) and Grother et al. (JP2012121850A; published June 28, 2012) (herein “Otsuka”) citing to “Catalent Announces Commencement of Supply of Abilify® Orally Disintegrating Tablets to Otsuka Pharmaceutical Co. Ltd. and Extensive Investments to its Zydis® to Technology Capabilities in Swindon, UK” (American Pharmaceutical Review, July 25, 2012, p. 1-5) (herein “American Pharmaceutical Review”).
Although the claims at issue are not identical, they are not patentably distinct because the instant claims are directed towards a method of treating autism spectrum disorder with an orally dispersible composition comprising cannabidiol, gelatin, and mannitol. The claims of the copending application are directed towards a method of treating an autoimmune disease or inflammatory condition in a subject with the same composition. Given that it was well known in the art to apply cannabidiol to the treatment of autism spectrum disorder as shown by Fleury-Teixeira above, the rejection incorporated herein by reference, one of ordinary skill in the art would have a reasonable expectation of success to apply the composition of the copending application to the treatment of autism spectrum disorder as well.
Claims 23-27 additionally recite that the composition additionally comprises an antipsychotic such as risperidone or aripiprazole. One of ordinary skill in the art would have a reasonable expectation of success to include an antipsychotic in the composition as demonstrated by Kikuchi, Otsuka, and Hobbs, the rejection above incorporated herein by reference.
This is a provisional nonstatutory double patenting rejection.
Claim(s) 1-13, 16-22 and 28-34 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-35 of copending Application No. 18/252,741 in view of Fleury-Teixeira et al. (Front. Neurol., 30 October 2019, Sec. Neuropharmacology, Volume 10, No. 1145, p. 1-8).
Although the claims at issue are not identical, they are not patentably distinct because the instant claims are directed towards a method of treating autism spectrum disorder with an orally dispersible composition comprising cannabidiol, gelatin, and mannitol. The claims of the copending application are directed towards a method of treating epilepsy in a subject with the same composition. Given that it was well known in the art to apply cannabidiol to the treatment of autism spectrum disorder as shown by Fleury-Teixeira above, the rejection incorporated herein by reference, one of ordinary skill in the art would have a reasonable expectation of success to apply the composition of the copending application to the treatment of autism spectrum disorder as well.
This is a provisional nonstatutory double patenting rejection.
Claim(s) 1-22 and 28-34 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-35 of copending Application No. 18/252,741 in view of Fleury-Teixeira et al. (Front. Neurol., 30 October 2019, Sec. Neuropharmacology, Volume 10, No. 1145, p. 1-8) and Rock et al. (Psychopharmacology, vol. 237, pages 2621–2631, (2020), published 02 June 2020).
Although the claims at issue are not identical, they are not patentably distinct because the instant claims are directed towards a method of treating autism spectrum disorder with an orally dispersible composition comprising cannabidiol, gelatin, and mannitol. The claims of the copending application are directed towards a method of treating epilepsy in a subject with the same composition. Given that it was well known in the art to apply cannabidiol to the treatment of autism spectrum disorder as shown by Fleury-Teixeira above, the rejection incorporated herein by reference, one of ordinary skill in the art would have a reasonable expectation of success to apply the composition of the copending application to the treatment of autism spectrum disorder as well.
Claims 15-16 additionally recite that the CBD is a CBD analog or derivative, but it would be prima facie obvious to substitute CBD for a CBD analog or derivative as shown by the teachings of Rock above, incorporated herein by reference.
This is a provisional nonstatutory double patenting rejection.
Claim(s) 1-13 and 16-34 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-35 of copending Application No. 18/252,741 in view of Fleury-Teixeira et al. (Front. Neurol., 30 October 2019, Sec. Neuropharmacology, Volume 10, No. 1145, p. 1-8), Kikuchi et al. (US9017737B2, published April 28, 2015), Hobbs et al. (Drugs in R&D, Volume 13, pages 281–288, (2013), Published: 30 October 2013) and Grother et al. (JP2012121850A; published June 28, 2012) (herein “Otsuka”) citing to “Catalent Announces Commencement of Supply of Abilify® Orally Disintegrating Tablets to Otsuka Pharmaceutical Co. Ltd. and Extensive Investments to its Zydis® to Technology Capabilities in Swindon, UK” (American Pharmaceutical Review, July 25, 2012, p. 1-5) (herein “American Pharmaceutical Review”).
Although the claims at issue are not identical, they are not patentably distinct because the instant claims are directed towards a method of treating autism spectrum disorder with an orally dispersible composition comprising cannabidiol, gelatin, and mannitol. The claims of the copending application are directed towards a method of treating epilepsy in a subject with the same composition. Given that it was well known in the art to apply cannabidiol to the treatment of autism spectrum disorder as shown by Fleury-Teixeira above, the rejection incorporated herein by reference, one of ordinary skill in the art would have a reasonable expectation of success to apply the composition of the copending application to the treatment of autism spectrum disorder as well.
Claims 23-27 additionally recite that the composition additionally comprises an antipsychotic such as risperidone or aripiprazole. One of ordinary skill in the art would have a reasonable expectation of success to include an antipsychotic in the composition as demonstrated by Kikuchi, Otsuka, and Hobbs, the rejection above incorporated herein by reference.
This is a provisional nonstatutory double patenting rejection.
Claim(s) 1-13, 16-22 and 28-34 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-46 of copending Application No. 18/317,977 in view of Fleury-Teixeira et al. (Front. Neurol., 30 October 2019, Sec. Neuropharmacology, Volume 10, No. 1145, p. 1-8).
Although the claims at issue are not identical, they are not patentably distinct because the instant claims are directed towards a method of treating autism spectrum disorder with an orally dispersible composition comprising cannabidiol, gelatin, and mannitol. The claims of the copending application are directed towards a method of treating a tic disorder in a subject with the same composition. Given that it was well known in the art to apply cannabidiol to the treatment of autism spectrum disorder as shown by Fleury-Teixeira above, the rejection incorporated herein by reference, one of ordinary skill in the art would have a reasonable expectation of success to apply the composition of the copending application to the treatment of autism spectrum disorder as well.
This is a provisional nonstatutory double patenting rejection.
Claim(s) 1-22 and 28-34 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-46 of copending Application No. 18/317,977 in view of Fleury-Teixeira et al. (Front. Neurol., 30 October 2019, Sec. Neuropharmacology, Volume 10, No. 1145, p. 1-8) and Rock et al. (Psychopharmacology, vol. 237, pages 2621–2631, (2020), published 02 June 2020).
Although the claims at issue are not identical, they are not patentably distinct because the instant claims are directed towards a method of treating autism spectrum disorder with an orally dispersible composition comprising cannabidiol, gelatin, and mannitol. The claims of the copending application are directed towards a method of treating a tic disorder in a subject with the same composition. Given that it was well known in the art to apply cannabidiol to the treatment of autism spectrum disorder as shown by Fleury-Teixeira above, the rejection incorporated herein by reference, one of ordinary skill in the art would have a reasonable expectation of success to apply the composition of the copending application to the treatment of autism spectrum disorder as well.
Claims 15-16 additionally recite that the CBD is a CBD analog or derivative, but it would be prima facie obvious to substitute CBD for a CBD analog or derivative as shown by the teachings of Rock above, incorporated herein by reference.
This is a provisional nonstatutory double patenting rejection.
Claim(s) 1-13 and 16-34 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-46 of copending Application No. 18/317,977 in view of Fleury-Teixeira et al. (Front. Neurol., 30 October 2019, Sec. Neuropharmacology, Volume 10, No. 1145, p. 1-8), Kikuchi et al. (US9017737B2, published April 28, 2015), Hobbs et al. (Drugs in R&D, Volume 13, pages 281–288, (2013), Published: 30 October 2013) and Grother et al. (JP2012121850A; published June 28, 2012) (herein “Otsuka”) citing to “Catalent Announces Commencement of Supply of Abilify® Orally Disintegrating Tablets to Otsuka Pharmaceutical Co. Ltd. and Extensive Investments to its Zydis® to Technology Capabilities in Swindon, UK” (American Pharmaceutical Review, July 25, 2012, p. 1-5) (herein “American Pharmaceutical Review”).
Although the claims at issue are not identical, they are not patentably distinct because the instant claims are directed towards a method of treating autism spectrum disorder with an orally dispersible composition comprising cannabidiol, gelatin, and mannitol. The claims of the copending application are directed towards a method of treating a tic disorder in a subject with the same composition. Given that it was well known in the art to apply cannabidiol to the treatment of autism spectrum disorder as shown by Fleury-Teixeira above, the rejection incorporated herein by reference, one of ordinary skill in the art would have a reasonable expectation of success to apply the composition of the copending application to the treatment of autism spectrum disorder as well.
Claims 23-27 additionally recite that the composition additionally comprises an antipsychotic such as risperidone or aripiprazole. One of ordinary skill in the art would have a reasonable expectation of success to include an antipsychotic in the composition as demonstrated by Kikuchi, Otsuka, and Hobbs, the rejection above incorporated herein by reference.
This is a provisional nonstatutory double patenting rejection.
Claim(s) 1-13, 16-22 and 28-34 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-44 of copending Application No. 18/317,964 in view of Fleury-Teixeira et al. (Front. Neurol., 30 October 2019, Sec. Neuropharmacology, Volume 10, No. 1145, p. 1-8).
Although the claims at issue are not identical, they are not patentably distinct because the instant claims are directed towards a method of treating autism spectrum disorder with an orally dispersible composition comprising cannabidiol, gelatin, and mannitol. The claims of the copending application are directed towards a method of treating COVID-19 in a subject with the same composition. Given that it was well known in the art to apply cannabidiol to the treatment of autism spectrum disorder as shown by Fleury-Teixeira above, the rejection incorporated herein by reference, one of ordinary skill in the art would have a reasonable expectation of success to apply the composition of the copending application to the treatment of autism spectrum disorder as well.
This is a provisional nonstatutory double patenting rejection.
Claim(s) 1-22 and 28-34 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-44 of copending Application No. 18/317,964 in view of Fleury-Teixeira et al. (Front. Neurol., 30 October 2019, Sec. Neuropharmacology, Volume 10, No. 1145, p. 1-8) and Rock et al. (Psychopharmacology, vol. 237, pages 2621–2631, (2020), published 02 June 2020).
Although the claims at issue are not identical, they are not patentably distinct because the instant claims are directed towards a method of treating autism spectrum disorder with an orally dispersible composition comprising cannabidiol, gelatin, and mannitol. The claims of the copending application are directed towards a method of treating COVID-19 in a subject with the same composition. Given that it was well known in the art to apply cannabidiol to the treatment of autism spectrum disorder as shown by Fleury-Teixeira above, the rejection incorporated herein by reference, one of ordinary skill in the art would have a reasonable expectation of success to apply the composition of the copending application to the treatment of autism spectrum disorder as well.
Claims 15-16 additionally recite that the CBD is a CBD analog or derivative, but it would be prima facie obvious to substitute CBD for a CBD analog or derivative as shown by the teachings of Rock above, incorporated herein by reference.
This is a provisional nonstatutory double patenting rejection.
Claim(s) 1-13 and 16-34 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-44 of copending Application No. 18/317,964 in view of Fleury-Teixeira et al. (Front. Neurol., 30 October 2019, Sec. Neuropharmacology, Volume 10, No. 1145, p. 1-8), Kikuchi et al. (US9017737B2, published April 28, 2015), Hobbs et al. (Drugs in R&D, Volume 13, pages 281–288, (2013), Published: 30 October 2013) and Grother et al. (JP2012121850A; published June 28, 2012) (herein “Otsuka”) citing to “Catalent Announces Commencement of Supply of Abilify® Orally Disintegrating Tablets to Otsuka Pharmaceutical Co. Ltd. and Extensive Investments to its Zydis® to Technology Capabilities in Swindon, UK” (American Pharmaceutical Review, July 25, 2012, p. 1-5) (herein “American Pharmaceutical Review”).
Although the claims at issue are not identical, they are not patentably distinct because the instant claims are directed towards a method of treating autism spectrum disorder with an orally dispersible composition comprising cannabidiol, gelatin, and mannitol. The claims of the copending application are directed towards a method of treating COVID-19 in a subject with the same composition. Given that it was well known in the art to apply cannabidiol to the treatment of autism spectrum disorder as shown by Fleury-Teixeira above, the rejection incorporated herein by reference, one of ordinary skill in the art would have a reasonable expectation of success to apply the composition of the copending application to the treatment of autism spectrum disorder as well.
Claims 23-27 additionally recite that the composition additionally comprises an antipsychotic such as risperidone or aripiprazole. One of ordinary skill in the art would have a reasonable expectation of success to include an antipsychotic in the composition as demonstrated by Kikuchi, Otsuka, and Hobbs, the rejection above incorporated herein by reference.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is found to be allowable.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/HEATHER DAHLIN/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629