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 claims provisional benefit of U.S. Provisional Application No. 63/342,934, filed May 17, 2022.
Claim Status
Claims 1, 3-9 and 11-44 are currently pending and subject to examination.
Withdrawn Rejections – Overcome by Amendment
The rejection of claims 35 and 41 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn.
The above rejection was overcome by Applicant’s amendment to the claims.
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 31-33 and 37 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 the claims are definite because they use a quantitative metric (Remarks, p. 9-10). 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 COVID-19 or the alleviation of COVID-19 symptoms. Therefore, in reading the claims and the specification, one of ordinary skill in the art would not know what methods would reduce the severity of a COVID-19 symptoms by at least 50% or reduce nasal secretions by at least 3-fold or 20-fold as instantly claimed.
The Applicant argues that each listed anti-viral drug in claim 37 achieves the same purpose satisfying MPEP’s standard (Remarks, p. 11). These arguments were fully considered but are not persuasive. Not all of the drugs listed in claim 37 are indicated for the treatment of COVID-19. The compounds of claim 37 are not members of the same recognized class because for example, peginterferon alfa-2a is a form of recombinant interferon used as part of combination therapy to treat chronic Hepatitis C while adapromine is an antiviral drug of the adamantane group for the treatment of influenza. The drugs of claim 37 have very different structures and indications and would not be expected to behave the same way in the context of the claimed invention. They also do not share a substantial structural feature.
Reiterated Rejection
Claims 31-33 and 37 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.
Claims 31-33 are indefinite because they merely define the invention in terms of results to be achieved and do not provide any clear restraints on the method of claim 1. One of ordinary skill in the art cannot determine the metes and bounds of these claims because it is unknown how the outcome of the method of claim 1 is further limiting to claim 1.
The Markush grouping of claim 37 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons:
The compounds of claim 37 are not members of the same recognized class because for example, peginterferon alfa-2a is a form of recombinant interferon used as part of combination therapy to treat chronic Hepatitis C while adapromine is an antiviral drug of the adamantane group for the treatment of influenza. The drugs of claim 37 have very different structures and indications and would not be expected to behave the same way in the context of the claimed invention. They also do not share a substantial structural feature.
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, 3-9, 12-19, 21-22, 26-29, 34, 40 and 44 under 35 U.S.C. 103 as being unpatentable over Esposito et al. (British Journal of Pharmacology, Volume 177, Issue 21: Themed Issue: The Pharmacology of COVID-19, Nov 2020, Pages 4811-5001) in view of “Science” (JOS Pharmaceuticals, Way BackMachine, Nov. 27, 2021) (herein “JOS”) and Grother et al. (WO 2022/074127 A2; Published April 14, 2022) is maintained.
The rejection of claim(s) 1, 3-9, 11-19, 21-22, 26-29, 34, 40 and 44 under 35 U.S.C. 103 as being unpatentable over Esposito et al. (British Journal of Pharmacology, Volume 177, Issue 21: Themed Issue: The Pharmacology of COVID-19, Nov 2020, Pages 4811-5001), “Science” (JOS Pharmaceuticals, Way BackMachine, Nov. 27, 2021) (herein “JOS”) and Grother et al. (WO 2022/074127 A2; Published April 14, 2022), as applied to claim(s) 1-9, 12-19, 21-22, 26-29, 34, 40 and 44 above, and further in view of Marco (CBD Mania, Jan. 26, 2021, pp. 1-16) is maintained.
The rejection of claim(s) 1, 3-9, 12-34, 40 and 44 under 35 U.S.C. 103 as being unpatentable over Esposito et al. (British Journal of Pharmacology, Volume 177, Issue 21: Themed Issue: The Pharmacology of COVID-19, Nov 2020, Pages 4811-5001) in view of “Science” (JOS Pharmaceuticals, Way BackMachine, Nov. 27, 2021) (herein “JOS”) and Grother et al. (WO 2022/074127 A2; Published April 14, 2022), as applied to claims 1-9, 12-19, 21-22, 26-29, 34, 40 and 44 above, and further in view of “CANnabiDiol for CoviD-19 pATiEnts With Mild to Moderate Symptoms (CANDIDATE)” (ClinicalTrials.gov, NCT04467918, Published Sept. 28, 2021, pp. 1-13) (herein “Candidate”) and Nguyen et al. (Science Advances, Volume 8, Issue 8, Feb 2022, pp. 1-18) is maintained.
The rejection of claim(s) 1, 3-9, 12-19, 21-22, 26-29 and 34-44 under 35 U.S.C. 103 as being unpatentable over Esposito et al. (British Journal of Pharmacology, Volume 177, Issue 21: Themed Issue: The Pharmacology of COVID-19, Nov 2020, Pages 4811-5001) in view of “Science” (JOS Pharmaceuticals, Way BackMachine, Nov. 27, 2021) (herein “JOS”) and Grother et al. (WO 2022/074127 A2; Published April 14, 2022), as applied to claims 1-9, 12-19, 21-22, 26-29, 34, 40 and 44 above, and further in view of Kleidon (WO 2021/202413 A1; Published Oct. 7, 2021) 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. JOS teaches CBD Zydis wafers. As demonstrated by Seager, cited by the Applicant, 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. 15-16). 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. 17). 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 [0013]). 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 [0222]), 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. 17). These arguments were fully considered but are not persuasive. Grother teaches that the suspension is cooled to 15-30°C after adding the solvent, matrix-former and structure former (Grother, Specification, paragraph [0013]), 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 [0230]). 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. 18-19). These arguments were fully considered but are not persuasive because the above deficiencies were addressed.
Reiterated Rejection
Claim(s) 1, 3-9, 12-19, 21-22, 26-29, 34, 40 and 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Esposito et al. (British Journal of Pharmacology, Volume 177, Issue 21: Themed Issue: The Pharmacology of COVID-19, Nov 2020, Pages 4811-5001) in view of “Science” (JOS Pharmaceuticals, Way BackMachine, Nov. 27, 2021) (herein “JOS”) and Grother et al. (WO 2022/074127 A2; Published April 14, 2022).
Claim 1 is directed towards a method for the treatment of COVID-19 caused by SARS-CoV-2 infection in a subject, the method comprising: administering to the subject in need thereof, via the oral mucosa, a rapidly infusing lyophilized composition comprising (a) a pharmaceutically acceptable binder and/or excipient system comprising gelatin and a sugar alcohol, and (b) a therapeutically effective amount of solid cannabidiol (CBD).
Esposito teaches the treatment of COVID-19 comprising administering an oral dose of cannabidiol (CBD) to the patient:
Identifying drugs effective in the new coronavirus disease 2019 (COVID-19) is crucial, pending a vaccine against SARS-CoV2. We suggest the hypothesis that cannabidiol (CBD), a non-psychotropic phytocannabinoid, has the potential to limit the severity and progression of the disease for several reasons:- (a) High-cannabidiol Cannabis sativa extracts are able to down-regulate the expression of the two key receptors for SARS-CoV2 in several models of human epithelia, (b) cannabidiol exerts a wide range of immunomodulatory and anti-inflammatory effects and it can mitigate the uncontrolled cytokine production responsible for acute lung injury, (c) being a PPARγ agonist, it can display a direct antiviral activity and (d) PPARγ agonists are regulators of fibroblast/myofibroblast activation and can inhibit the development of pulmonary fibrosis, thus ameliorating lung function in recovered patients. We hope our hypothesis, corroborated by preclinical evidence, will inspire further targeted studies to test cannabidiol as a support drug against the COVID-19 pandemic.
Esposito, Abstract;
We suggest that cannabidiol should be given orally, starting at 100 mg•day−1 titrating up to 300 mg•day−1 (2.5 mg•kg−1*day−1).
Esposito, col. 1, p. 4969;
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Esposito, Fig. 1, p. 4969.
Esposito also teaches that CBD can be delivered over the oral mucosa, for example, using a mouth wash:
In a recent paper, high-cannabidiol (CBD) Cannabis sativa extracts have been reported to down-regulate angiotensin-converting enzyme 2 (ACE2) and transmembrane serine protease 2 (TMPRSS2) enzymes, crucial viral gateways in oral, lung and intestinal epithelia constituting important routes of SARS-CoV2 invasion (Wang et al., 2020). By down-regulating ACE2 and TMPRSS2 enzymes, the authors suggested that high-cannabidiol products, such as mouth washes, as a preventative strategy in COVID-19 infection to limit SARS-CoV2 entry into susceptible hosts. While this article puts forward the concept that cannabinoids-containing products may serve as a preventative treatment for topical use…
Esposito, p. 4967-4968.
While Esposito does not teach a rapidly infusing composition comprising CBD, gelatin and sugar alcohol, delivered via the oral mucosa, 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.
JOS teaches se•d8, a wafer comprising CBD with the Zydis wafer technology (JOS, p. 3). It is well known that the Zydis wafer 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 (lyophilized) oral dispersible or disintegrating dosage form (Grother, Specification, ¶ 0095), 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 (¶ 0009). Grother teaches that the dosage form is placed in the oral cavity, such as under the tongue or in the buccal region (¶ 0012) and rapidly dissolves to allow sublingual absorption (¶ 0097). Grother teaches that the API is in a solid form (crystalline) in the ODT (Grother, Specification, ¶ 0009).
Therefore, claim 1 was prima facie obvious at the time of filing.
Claim 2 is directed towards the method of claim 1, wherein the rapidly infusing composition is lyophilized. The Zydis technology involves a lyophilized (freeze-dried) composition (Grother, Specification, ¶ 0002). Therefore, claim 2 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, ¶ 0149). 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 7 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, ¶ 0009). In the specific examples, gelatin and mannitol are the only matrix formers and structure formers used (¶ 0140-0157). 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 (¶ 0144, 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.% (¶ 119)). 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 7 were prima facie obvious at the time of filing.
Claim 6 is directed towards the method of claim 1, wherein the gelatin is bovine gelatin. As shown in the rejection of claim 5, Grother teaches bovine gelatin.
Therefore, claim 6 was prima facie obvious at the time of filing.
Claim 8 is directed towards the method of claim 1, wherein the sugar alcohol comprises mannitol. As shown in the rejection of claim 7, Grother teaches mannitol.
Therefore, claim 8 was prima facie obvious at the time of filing.
Claim 9 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, ¶ 0137). 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 9 was prima facie obvious at the time of filing.
Claim 13 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 14 is directed towards the method of claim 13, wherein the rapidly infusing composition comprises the flavorant, and the flavorant comprises lemon-lime flavor. Claim 15 is directed towards the method of claim 13, wherein the rapidly infusing composition comprises the colorant, and the colorant comprises FD&C Yellow #5. Claim 16 is directed towards the method of claim 13, 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 13-16 were prima facie obvious at the time of filing.
Claim 17 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 17 was prima facie obvious at the time of filing.
Claim 18 is directed towards the method of claim 1, wherein the therapeutically effective amount of CBD is from 0.1 mg/kg/day to less than 7 mg/kg/day. Claim 19 is directed towards the method of claim 1, wherein the therapeutically effective amount of CBD 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 to administer about 0.1 mg/kg/day to less than 5 mg/kg/day because Esposito teaches “that cannabidiol should be given orally, starting at 100 mg•day−1 titrating up to 300 mg•day−1 (2.5 mg•kg−1*day−1).” (Esposito, col. 1, p. 4969).
Therefore, claims 18-19 were prima facie obvious at the time of filing.
Claim 21 is directed towards the method of claim 1, wherein CBD is the only active therapeutic ingredient in the rapidly infusing composition.
One of ordinary skill in the art would have a reasonable expectation of success to administer CBD as the only active ingredient in the composition because Esposito teaches administering just CBD to the patient (Esposito, Abstract; Fig. 1, p. 4969).
Therefore, claim 21 was prima facie obvious at the time of filing.
Claim 22 is directed towards the composition of claim 1, wherein the subject is not administered a cannabinoid other than CBD.
One of ordinary skill in the art would have a reasonable expectation of success to administer CBD as the only cannabinoid to the patient because Esposito teaches administering just CBD to the patient (Esposito, Abstract; Fig. 1, p. 4969) and JOS teaches that the CBD Zydis wafer is free of THC (JOS, p. 3 (“JOS Pharmaceuticals nevertheless removes all naturally occurring THC”)).
Therefore, claim 22 was prima facie obvious at the time of filing.
Claim 26 is directed towards the method of claim 1, wherein the subject is asymptomatic. Claim 27 is directed towards the method of claim 1, wherein the subject is first administered the rapidly infusing composition at a time that is 5 days or less from the start of SARS-CoV-2 infection or 5 days or less from receiving a positive test result indicating SARS-CoV-2 infection. Claim 28 is directed towards the method of claim 1, wherein the subject is first administered the rapidly infusing composition at a time that is 3 days or less from the onset of a COVID-19 symptom. Claim 44 is directed towards 44 the method of claim 1, wherein the subject is asymptomatic and had been exposed to SARS-CoV-2 before the administering.
One of ordinary skill in the art would have a reasonable expectation of success to administer the composition when the subject is asymptomatic, at a time less than 5 days or less than 3 days from the start of the COVID-19 infection or onset of symptoms because Esposito teaches that CBD can be used as a preventative treatment to limit SARS-CoV2 entry into susceptible host cells, for example, oral lung and intestinal epithelia (Esposito, p. 4967-68), also displays antiviral activity (Abstract), and to administer at an early stage of the disease to stop cytokine storm (col. 1, p. 4969).
Therefore, claims 26-28 and 44 were prima facie obvious at the time of filing.
Claim 29 is directed towards the method of claim 1, wherein the subject has long COVID. One of ordinary skill in the art would have a reasonable expectation of success to treat long COVID with the method of claim 1 because Esposito teaches CBD for post-infection sequelae:
Recent reports show that a subset of COVID-19 survivors can develop post-infectious sequelae with persistently impaired lung function and pulmonary fibrosis (Ng, Li, Lee, & Ma, 2020). PPARγ receptors represent a potential therapeutic target in fibrotic lung diseases, given their ability of regulating fibroblast/myofibroblast acti-vation and collagen secretion in murine models (Milam et al., 2008).Notably, cannabidiol has been shown to reduce pulmonary inflammation and fibrosis in animal models of asthma (Vuolo et al., 2019). It is therefore conceivable that cannabidiol being a PPARγ receptor agonist, could potentially limit the start of late-onset pulmonary fibrosis in COVID-19-recovered patients.
Esposito, col. 2, p. 4968.
Therefore, claim 29 was prima facie obvious at the time of filing.
Claim 34 is directed towards the method of claim 1, wherein the rapidly infusing composition is administered in combination with an antiviral drug.
Claim 40 is directed towards the method of claim 1, wherein the rapidly infusing composition is administered in combination with a monoclonal antibody.
One of ordinary skill in the art would have a reasonable expectation of success to administer the CBD composition in combination with an antiviral drug or a monoclonal antibody because Esposito suggests administering CBD in combination with antiviral drugs and monoclonal antibodies:
[T]he use of antiviral agents alone may not be sufficient to stop the cytokine storm and respiratory distress in severely ill patients. In the attempt of reducing their overall mortality, it is therefore essential to identify new therapeutics options that are able to mitigatie the cytokine storm (Huang et al., 2020). Nonetheless, redundancies within the complex cytokine network still represent a major obstacle to treatment with monoclonal antibodies. The ideal drug candidate should be already in use for other indications, have a favourable safety profile, a multitargeted action, should be able to synergistically mitigate the cytokine storm and should act as an immunomodulatory rather than an immunosuppressant drug.
In a recent paper, high-cannabidiol (CBD) Cannabis sativa extracts…
Esposito, col. 2, p. 4967.
Therefore, claims 34 and 40 were prima facie obvious at the time of filing.
Claim(s) 1, 3-9, 11-19, 21-22, 26-29, 34, 40 and 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Esposito et al. (British Journal of Pharmacology, Volume 177, Issue 21: Themed Issue: The Pharmacology of COVID-19, Nov 2020, Pages 4811-5001), “Science” (JOS Pharmaceuticals, Way BackMachine, Nov. 27, 2021) (herein “JOS”) and Grother et al. (WO 2022/074127 A2; Published April 14, 2022), as applied to claim(s) 1-9, 12-19, 21-22, 26-29, 34, 40 and 44 above, and further in view of Marco (CBD Mania, Jan. 26, 2021, pp. 1-16).
The rejection of claims 1-9, 12-19, 21-22, 26-29 and 44 above is incorporated herein by reference.
Claim 11 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 Esposito does not teach the form of the CBD, 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).
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 crystally have a purity level of around 99% (Marco, p. 3).
Therefore, claim 11 was prima facie obvious at the time of filing.
Claim 12 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, ¶ 0122), and teaches examples with a D50 of e.g. 38.024 microns and 21.495 microns (batch 3, Fig. 76).
Therefore, claim 12 was prima facie obvious at the time of filing.
Claim(s) 1-9, 12-34, 40 and 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Esposito et al. (British Journal of Pharmacology, Volume 177, Issue 21: Themed Issue: The Pharmacology of COVID-19, Nov 2020, Pages 4811-5001) in view of “Science” (JOS Pharmaceuticals, Way BackMachine, Nov. 27, 2021) (herein “JOS”) and Grother et al. (WO 2022/074127 A2; Published April 14, 2022), as applied to claims 1-9, 12-19, 21-22, 26-29, 34, 40 and 44 above, and further in view of “CANnabiDiol for CoviD-19 pATiEnts With Mild to Moderate Symptoms (CANDIDATE)” (ClinicalTrials.gov, NCT04467918, Published Sept. 28, 2021, pp. 1-13) (herein “Candidate”) and Nguyen et al. (Science Advances, Volume 8, Issue 8, Feb 2022, pp. 1-18).
The rejection of claims 1-9, 12-19, 21-22, 26-29 and 44 above is incorporated herein by reference.
Claim 20 is directed towards the method of claim 1, wherein the rapidly infusing composition is administered to the subject 1 to 3 times per day.
While Esposito teaches to administer the CBD daily (Esposito, col. 1, p. 4969) but not if this is in single or divided doses, one of ordinary skill in the art would have a reasonable expectation of success to administer the CBD 1 to 3 times per day because such dosing is commonly known in the art for the treatment of COVID-19.
For example, Candidate teaches to administer 300 mg/day in divided doses of 150 mg to patients with mild to moderate SARS-CoV-2 infection (Candidate, Detailed Description, ¶ 1-2) and Nguyen teaches twice daily does of CBD for SARS-CoV-2 infected mice and established the preclinical efficacy of CBD as an antiviral drug for SARS-CoV-2 during early stages of infection (Nguyen, col. 1, p. 8).
Therefore, claim 20 was prima facie obvious at the time of filing.
Claim 23 is directed towards the method of claim 1, wherein the subject presents with at least one symptom selected from the group consisting of ageusia, anosmia, cough, diarrhea, fatigue, fever, headache, migraine headache, joint pain, muscle pain, nasal congestion, parosmia, runny nose, shortness of breath, and sore throat.
Esposito teaches to treat patients with active COVID-19 infection to limit its severity and mitigate cytokine release and pulmonary inflammation and fibrosis (Esposito, Fig. 1, p. 4969). As such, Esposito teaches to treat patients presenting with COVID-19 and who have symptoms. While Esposito does not list the symptoms of COVID-19, one of ordinary skill in the art would have a reasonable expectation of success to treat patients with symptoms such as the above because it is commonly known in the art that these are common symptoms of COVID-19.
For example, Candidate teaches the treatment of patients with mild to moderate COVID-19 which may present with fever (Candidate, Detailed Description, ¶ 3) and Nguyen teaches that SARS-CoV-2 causes cold symptoms (Nguyen, col. 1, p. 1).
Therefore, claim 23 was prima facie obvious at the time of filing.
Claims 24-25 are directed towards the method of claim 1, wherein the subject presents with a positive nucleic acid test or antigen test for SARS-CoV-2.
While Esposito does not specifically teach that the subject has a positive test result for COVID-19, one of ordinary skill in the art would have a reasonable expectation of success to treat a patient with a positive nucleic acid test or antigen test because CBD is commonly known in the art for patients who test positive for COVID-19.
For example, Candidate teaches to administer CBD to patients with a positive RT-PCR test result (Candidate, Criteria, No. 1). For example, Nguyen teaches that patients with COVID-19 can be identified by antigen detection (Nguyen, Table S1, concept_id 742224).
Therefore, claims 24-25 were prima facie obvious at the time of filing.
Claim 30 is directed towards the method of claim 1, wherein the SARS-CoV-2 is a variant selected from the group consisting of Alpha, Beta, Gamma, Delta, and Omicron.
While Esposito does not teach the variant of SARS-CoV-2, one of ordinary skill in the art would a have a reasonable expectation of success to treat the variants such as Alpha, Beta, Gamma, Delta, and Omicron because it is commonly known in the art that CBD is effective against such variants.
For example, Nguyen teaches that CBD comparably inhibits the original SARS-CoV-2 strain, as well as the alpha, beta, and gamma variants (Nguyen, col. 2, p. 2).
Therefore, claim 30 was prima facie obvious at the time of filing.
Claim 31 is directed towards the method of claim 1, wherein a severity or a frequency of a COVID-19 symptom is reduced by at least 50%, relative to the frequency or severity observed prior to administration of the rapidly infusing composition.
Esposito teaches to administer CBD for the treatment of COVID-19 and mitigation of acute lung injury. While Esposito does not specifically teach reduction of severity and frequency of severity of symptoms by at least 50%, One of ordinary skill in the art would have a reasonable expectation of success to reduce the severity or frequency of a COVID-19 symptom by at least 50%, relative to the frequency or severity observed prior to administration of the rapidly infusing composition because one would expect most COVID-19 patients to improve over time and because CBD is commonly known in the art for the reduction of COVID-19 symptoms.
For example, Candidate teaches that the primary outcome measure is time to COVID-19 symptom relief and number of participants with negative Clinical CoVid19 symptoms (Candidate, Primary Outcome Measures, No 2). Moreover, Nguyen teaches that “CBD has… the potential not only to act as an antiviral agent at early stages of infection but also to protect the host against an overactive immune system at later stages.” (Nguyen, col. 2, p. 9), “CBD and its metabolite 7-OH-CBD can block SARS-CoV-2 infection at early and even later stages of infection.” (col. 2, p. 8), and “CBD also suppresses cytokine activation in response to viral infection, reducing the likelihood of immune cell recruitment and subsequent cytokine storms within the lungs and other affected tissues” (col. 1, p. 9).
Therefore, claim 31 was prima facie obvious at the time of filing.
Claim 32 is directed towards the method of claim 1, wherein a viral load of the subject as measured by nasal secretion is reduced by at least 3-fold, relative to the viral load prior to administration of the rapidly infusing composition. Claim 33 is directed towards the method of claim 1, wherein a viral load of the subject as measured by lung secretion is reduced by at least 20-fold, relative to the viral load prior to administration of the rapidly infusing composition.
As shown above, Esposito teaches that CBD has antiviral activity. While Esposito does not explicitly teach that the viral load is reduced by at least 3 fold in nasal secretion and 20 fold in lung secretions, one of ordinary skill in the art would have a reasonable expectation of success to observe these results because it is commonly known in the art that CBD can reduce viral loads by these amounts.
For example, Nguyen teaches that:
CBD treatment significantly inhibited viral replication in lungs and nasal turbinates at day 5 after infection in a dose-dependent manner (Fig. 8, B and C). The lower dose of CBD reduced viral load by 4.8-fold in lungs and 3.7-fold in nasal turbinates, while the higher dose decreased viral titers by 40- and 4.8-fold in lungs and nasal turbinates, respectively.
Nguyen, col. 1, p. 8.
Therefore, claims 32-33 were prima facie obvious at the time of filing.
Claim(s) 1-9, 12-19, 21-22, 26-29 and 34-44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Esposito et al. (British Journal of Pharmacology, Volume 177, Issue 21: Themed Issue: The Pharmacology of COVID-19, Nov 2020, Pages 4811-5001) in view of “Science” (JOS Pharmaceuticals, Way BackMachine, Nov. 27, 2021) (herein “JOS”) and Grother et al. (WO 2022/074127 A2; Published April 14, 2022), as applied to claims 1-9, 12-19, 21-22, 26-29, 34, 40 and 44 above, and further in view of Kleidon (WO 2021/202413 A1; Published Oct. 7, 2021).
The rejection of claims 1-9, 12-19, 21-22, 26-29 and 44 above is incorporated herein by reference.
Claim 35 is directed towards the method of claim 34, wherein the antiviral drug is at least one selected from the group consisting of amiodarone, artesunate, chlorpromazine, clemastine, elacridar, favipiravir, lopinavir, molnupiravir, nirmatrelvir, pyronaridine, remdesivir, ribavirin, ritonavir, sertraline, triazavirin, and umifenovir.
Esposito teaches CBD as “a useful addition to the treatment of COVID-19” (col. 1, p. 4970) and that “antiviral agents alone may not be sufficient to stop the cytokine storm” (col. 2, p. 4967), suggesting the use of CBD in combination with existing antiviral therapies.
While Esposito does not explicitly teach CBD in combination with a specific antiviral drug, one of ordinary skill in the art would have a reasonable expectation of success to administer CBD in combination with a specific antiviral drug such as remdesivir because it is commonly known in the art to administer CBD in combination with a specific antiviral drug such as remdesivir to treat viral infections.
For example, Kleidon teaches compositions with reduced first pass metabolism comprising cannabinoids (Kleidon, Specification, ¶0003) such as CBD administered in combination with an additional therapeutic agent (¶0060) for the treatment of viral infections such as COVID-19 (¶0070) wherein the additional therapeutic is useful for the treatment of a viral infection, for example lopinavir, ritonavir, and remdesivir (¶0021).
Therefore, claim 34-35 were prima facie obvious at the time of filing.
Claim 36 is directed towards the method of claim 34, wherein the antiviral drug is an RNA virus antiviral drug. Claim 37 is directed towards the method of claim 36, wherein the RNA virus antiviral drug is at least one selected from the group consisting of adapromine, amantadine, asunaprevir, baloxavir marboxil, beclabuvir, bemnifosbuvir, boceprevir, bulevirtide, ciluprevir, CMX521,daclatasvir, daclatasvir, danoprevir, dasabuvir, deleobuvir, eicar, elbasvir, faldaprevir, favipiravir, filibuvir, galidesivir, glecaprevir, grazoprevir, grazoprevir, GS-441524, GS-6620, IDX-184, interferon alfa 2b, laninamivir, ledipasvir, ledipasvir, lufotrelvir, mericitabine, merimepodib, MK-608, molnupiravir, moroxydine, narlaprevir, nirmatrelvir, NITD008, odalasvir, ombitasvir, ombitasvir, oseltamivir, paritaprevir, paritaprevir, peginterferon alfa-2a, peginterferon alfa-2b, peramivir, pibrentasvir, pibrentasvir, pimodivir, pleconaril, presatovir, radalbuvir, ravidasvir, remdesivir, ribavirin, rimantadine, ritonavir, ruzasvir, samatasvir, setrobuvir, simeprevir, sofosbuvir, sofosbuvir, sofosbuvir, sofosbuvir, sofosbuvir, sovaprevir, taribavirin, tegobuvir, telaprevir, TMC- 647055, triazavirin, umifenovir, uprifosbuvir, valopicitabine, vaniprevir, vedroprevir, velpatasvir, velpatasvir, velpatasvir, voxilaprevir, voxilaprevir, and zanamivir.
One of ordinary skill in the art would have a reasonable expectation of success to administer CBD in combination with an RNA virus antiviral drug because it is commonly known in the art to administer CBD in combination with an RNA virus antiviral drug to treat viral infections.
For example, Kleidon teaches to administer CBD in combination with baloxavir, ritonavir, and remdesivir (¶0021).
Therefore, claims 36-37 were prima facie obvious at the time of filing.
Claim 38 is directed towards the method of claim 1, wherein the rapidly infusing composition is administered in combination with an angiotensin-converting-enzyme inhibitor. Claim 39 is directed towards the method of claim 38, wherein the angiotensin-converting-enzyme inhibitor is at least one selected from the group consisting of alacepril, benazepril, captopril, ceronapril, cilazapril, delapril, enalapril, fosinopril, imidapril, lisinopril, moexipril, perindopril, quinapril, ramipril, rentiapril, spirapril, temocapril, trandolapril, and zofenopril.
Esposito teaches that angiotensin converting enzyme 2 (ACE2) is crucial for viral entry in COVID-19 infection (Esposito, p. 4967-4968).
While Esposito does not teach CBD in combination with an ACE inhibitor, one of ordinary skill in the art would have a reasonable expectation of success to administer CBD in combination with ACE inhibitors because it is commonly known in the art to administer CBD in combination with ACE inhibitors.
For example, Kleidon teaches CBD in combination with ACE inhibitors (Kleidon, Specification, ¶0057) including Alacepril, Captopril, Zefnopril, Enalapril, Ramipril, Quinapril, Perindopril, Lisinopril, Benazepril, Imidapril, Tradolapril, Cilazapril, and Fosinopril (¶0058).
Therefore, claims 38-39 were prima facie obvious at the time of filing.
Claim 41 is directed towards the method of claim 40, wherein the monoclonal antibody is at least one selected from the group consisting of bamlanivimab, bamlanivimab/etesevimab, baricitinib, casirivimab, casirivimab/imdevimab, cilgavimab, etesevimab, imdevimab, lenzilumab,regdanvimab, sarilumab, sotrovimab, tixagevimab, tixagevimab/cilgavimab, tixagevimab/cilgavimab, and tocilizumab.
Esposito suggests that CBD would be administered in combination with monoclonal antibodies:
[R]edundancies within the complex cytokine network still represent a major obstacle to treatment with monoclonal antibodies. The ideal drug candidate should be already in use for other indications, have a favourable safety profile, a multitargeted action, should be able to synergistically mitigate the cytokine storm and should act as an immunomodulatory rather than an immunosuppressant drug.
In a recent paper, high-cannabidiol (CBD) Cannabis sativa extracts…
Esposito, col. 2, p. 4967.
While Esposito does specific monoclonal antibodies in combination with the CBD, one of ordinary skill in the art would have a reasonable expectation of success to administer the claimed monoclonal antibody in combination with CBD because it is commonly known in the art to administer these monoclonal antibodies with CBD.
For example, Kleidon teaches CBD in combination with tocilizumab, a monoclonal antibody drug (Kleidon, Specification, ¶0010).
Therefore, claims 40-41 were prima facie obvious at the time of filing.
Claim 42 is directed towards the method of claim 1, wherein the rapidly infusing composition is administered in combination with an angiotensin II receptor blocker. Claim 43 is directed towards the method of claim 42, wherein the angiotensin II receptor blocker is at least one selected from the group consisting of azilsartan, candesartan, eprosartan, fimasartan, irbesartan, losartan, olmesartan, tasosartan, telmisartan, and valsartan.
While Esposito does not teach CBD in combination with an angiotensin II receptor blocker, one of ordinary skill in the art would have a reasonable expectation of success to administer the CBD in combination with an angiotensin II receptor blocker because it is commonly known in the art to administer CBD in combination with angiotensin II receptor blockers.
For example, Kleidon teaches CBD in combination with angiotensin II receptor blockers (ARBs) (Kleidon, Specification, ¶0010), wherein the ARB is Azilsartan, Candesartan, Eprosartan, Irbesartan, Losartan, Olmesartan, Telmisartan, Valsartan, etc. (¶0058).
Therefore, claims 42-43 were 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.
The previously presented nonstatutory double patenting rejections and provisional nonstatutory double patenting rejections presented in the office action dated Sept. 19, 2025 are maintained.
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. 21). 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) 1-9, 12-19, 21-22, 26-29, 34, 40 and 44 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 Esposito et al. (British Journal of Pharmacology, Volume 177, Issue 21: Themed Issue: The Pharmacology of COVID-19, Nov 2020, Pages 4811-5001).
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 1-9 and Esposito teaches to apply cannabinoid compositions for the treatment of COVID-19 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) 1-44 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 Esposito et al. (British Journal of Pharmacology, Volume 177, Issue 21: Themed Issue: The Pharmacology of COVID-19, Nov 2020, Pages 4811-5001), Nguyen et al. (Science Advances, Volume 8, Issue 8, Feb 2022, pp. 1-18) and Kleidon (WO 2021/202413 A1; Published Oct. 7, 2021).
Although the claims at issue are not identical, they are not patentably distinct because the instant claims are directed towards a method of treating COVID-19 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 COVID-19 as shown by Esposito, Nguyen and Kleidon above, the rejections 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 COVID-19 as well.
Therefore, claims 1-44 are rejected on the ground of nonstatutory double patenting.
Claim(s) 1-44 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 Esposito et al. (British Journal of Pharmacology, Volume 177, Issue 21: Themed Issue: The Pharmacology of COVID-19, Nov 2020, Pages 4811-5001), Nguyen et al. (Science Advances, Volume 8, Issue 8, Feb 2022, pp. 1-18) and Kleidon (WO 2021/202413 A1; Published Oct. 7, 2021).
Although the claims at issue are not identical, they are not patentably distinct because the instant claims are directed towards a method of treating COVID-19 with an orally dispersible composition comprising cannabidiol, gelatin, and mannitol. The claims of the copending application are directed towards a method of treating Alzheimers in a subject with the same composition. Given that it was well known in the art to apply cannabidiol to the treatment of COVID-19 as shown by Esposito, Nguyen and Kleidon above, the rejections 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 COVID-19 as well.
This is a provisional nonstatutory double patenting rejection.
Claim(s) 1-44 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 Esposito et al. (British Journal of Pharmacology, Volume 177, Issue 21: Themed Issue: The Pharmacology of COVID-19, Nov 2020, Pages 4811-5001), Nguyen et al. (Science Advances, Volume 8, Issue 8, Feb 2022, pp. 1-18) and Kleidon (WO 2021/202413 A1; Published Oct. 7, 2021).
Although the claims at issue are not identical, they are not patentably distinct because the instant claims are directed towards a method of treating COVID-19 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 COVID-19 as shown by Esposito, Nguyen and Kleidon above, the rejections 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 COVID-19 as well.
This is a provisional nonstatutory double patenting rejection.
Claim(s) 1-44 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-34 of copending Application No. 18/252,668 in view of Esposito et al. (British Journal of Pharmacology, Volume 177, Issue 21: Themed Issue: The Pharmacology of COVID-19, Nov 2020, Pages 4811-5001), Nguyen et al. (Science Advances, Volume 8, Issue 8, Feb 2022, pp. 1-18) and Kleidon (WO 2021/202413 A1; Published Oct. 7, 2021).
Although the claims at issue are not identical, they are not patentably distinct because the instant claims are directed towards a method of treating COVID-19 with an orally dispersible composition comprising cannabidiol, gelatin, and mannitol. The claims of the copending application are directed towards a method of treating autism in a subject with the same composition. Given that it was well known in the art to apply cannabidiol to the treatment of COVID-19 as shown by Esposito, Nguyen and Kleidon above, the rejections 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 COVID-19 as well.
This is a provisional nonstatutory double patenting rejection.
Claim(s) 1-44 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 Esposito et al. (British Journal of Pharmacology, Volume 177, Issue 21: Themed Issue: The Pharmacology of COVID-19, Nov 2020, Pages 4811-5001), Nguyen et al. (Science Advances, Volume 8, Issue 8, Feb 2022, pp. 1-18) and Kleidon (WO 2021/202413 A1; Published Oct. 7, 2021).
Although the claims at issue are not identical, they are not patentably distinct because the instant claims are directed towards a method of treating COVID-19 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 COVID-19 as shown by Esposito, Nguyen and Kleidon above, the rejections 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 COVID-19 as well.
This is a provisional nonstatutory double patenting rejection.
Claim(s) 1-44 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 Esposito et al. (British Journal of Pharmacology, Volume 177, Issue 21: Themed Issue: The Pharmacology of COVID-19, Nov 2020, Pages 4811-5001), Nguyen et al. (Science Advances, Volume 8, Issue 8, Feb 2022, pp. 1-18) and Kleidon (WO 2021/202413 A1; Published Oct. 7, 2021).
Although the claims at issue are not identical, they are not patentably distinct because the instant claims are directed towards a method of treating COVID-19 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 COVID-19 as shown by Esposito, Nguyen and Kleidon above, the rejections 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 COVID-19 as well.
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).
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/HEATHER DAHLIN/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629