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/US2021/057938, filed Nov. 3, 2021.
The Application claims domestic priority benefit of 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. None of these domestic applications, however, disclose the claimed method of treating an autoimmune disease.
The effective filing date of the claimed invention is Nov. 3, 2021.
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.
Status of the Claims – Response to Restriction/ Election Requirement
Claims 1-35 are currently pending.
Applicant’s election of (i) cannabidiol (20-70 wt. %), mannitol (5-35 wt. %), and a mixture of sucralose and acesulfame-K (0-10 wt. %) as the composition, and (ii) rheumatoid arthritis as the indication, in the reply filed on Nov. 20, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
The Applicant merely presents a broad allegation that “the subject matter possess a corresponding inventive concept” but does not explain why there is an inventive concept required for unity of invention. A mere broad allegation that the requirement is in error does not comply with the requirement of 37 CFR 1.111 that the applicant distinctly and specifically point out the supposed errors in the restriction requirement (MPEP § 818.01(a)).
Claims 1-12, 15, and 18-23 read on the elected invention. Claims 13-14, 16-17 and 24-35 are withdrawn.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
“A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.”
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-9, 15, and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over “Catalent to Partner with Ethicann on New Fast-Dissolve Cannabinoid-Based Treatment for Multiple Sclerosis Spasticity” (Catalent, p. 1-3, Dec. 3, 2019) (herein “Catalent”) (of record, cited in prior office action) in view of Grother et al. (US 2023/0364013 A1; published Nov. 16, 2023; effectively filed Oct. 8, 2020), Monteith et al. (US20080152712A1; published June 26, 2008) and Amipara & Gupta (Journal of Drug Delivery & Therapeutics; 2013, 3(1), 85-92)
Claim 1 is directed towards a method of treating an autoimmune disease and/or inflammatory condition 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 thereof.
Catalent discloses an orally disintegrating tablet (ODT) comprising CBD using Zydis technology for the treatment of the autoimmune disease multiple sclerosis (Catalent, p. 1-2). Catalent teaches that “CBDs and THCs are notoriously insoluble and poorly bioavailable so a Zydis sublingual dosage form provides a drug delivery solution by avoiding first pass metabolism.” (Catalent, p. 3).
While Catalent does not teach that the ODT comprises mannitol and gelatin, one of ordinary skill in the art would have a reasonable expectation of success to formulate the ODT using gelatin and mannitol because Zydis technology is commonly known in the art to comprise gelatin and mannitol.
For example, Grother teaches Zydis Epinephrine, a freeze dried oral dispersible or disintegrating dosage form (Grother, Specification, ¶ 0096), 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 (¶ 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).
For example, Monteith teaches Zyprexa Zydis and Claritin RediTabs made with Zyprexa technology, both comprising gelatin and mannitol:
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Monteith, Specification, p. 9, (¶ 0063).
In an interview with the Applicant for related Applications, (18/252,668 and 18/317,964) the Applicant asserted that an ordinary artisan would not know how to use Zydis technology with CBD because CBD is insoluble. These arguments were fully considered but are not persuasive. Insoluble solid forms are well known to be the preferred APIs for use with Zydis technology. For example, Amipara teaches that the ideal API is a water insoluble solid form:
The freeze-drying technique has demonstrated improved absorption and increase in bioavailability. The Zydis formulations consist of a drug physically trapped in a water-soluble matrix (saccharine mixture and polymer), which is freeze dried to produce a product that dissolves rapidly when placed in mouth. The ideal candidate for Zydis technology should be chemically stable and water insoluble and particle size preferably less than 50 micron. Water soluble drugs might form eutectic mixtures and not freeze adequately, so dose is limited to 60 mg and the maximum drug limit is 400 mg for water insoluble drug as large particle sizes might present sedimentation problems during manufacture.
Amipara, p. 86-87.
One of ordinary skill in the art would clearly have no difficulty in applying the teachings of Catalent to develop a CBD Zydis formulation. Zydis technology is well known and characterized in the art, particularly for solid water-insoluble substances, as demonstrated by Grother, Monteith and Amipara.
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, ¶ 0164). For example, Amipara teaches that Zydis tablets are formulated to dissolve in 2-3 seconds when placed in the mouth:
Zydis, the best known of the fast-dissolving/disintegrating tablet preparations, was the first marketed new technology tablet. The tablet dissolves in the mouth within seconds after placement on the tongue. A Zydis tablet is produced by lyophilizing or freeze-drying the drug in a matrix usually consisting of gelatin. The product is very lightweight and fragile, and must be dispensed in a special blister pack. Patients should be advised not to push the tablets through the foil film, but instead peel the film back to release the tablet. The Zydis product is made to dissolve on the tongue in 2 to 3 seconds. The Zydis formulation is also self-preserving because the final water concentration in the freeze-dried product is too low to allow for microbial growth. The Zydis formulation utilizes flavors and sweeteners to optimize the taste of the dosage form. In addition, it utilizes microencapsulation with specialized polymers or complexation with ion exchange resins to mask the bitter tasting drug. The combination of lyophilization and taste masking creates a product that is both pleasing to the eye and also to the senses of taste and touch. A major claim of the Zydis product is increased bioavailability compared to traditional tablets. Because of its dispersion and dissolution in saliva while still in the oral cavity, there can be a substantial amount of pregastric absorption from this formulation. Buccal, pharyngeal and gastric regions are all areas of absorption of the Zydis formulation.
Amipara, p. 88-89 (emphasis added).
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, ¶ 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)).
For example, Monteith teaches that a 10 mg Claritin RediTab comprises 33.8% Gelatin NF and 27.1 % Mannitol USP (Monteith, Specification, p. 9, (¶ 0063), Table 3, shown above in the rejection of claim 1).
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. One of ordinary skill in the art would have a reasonable expectation of success to use bovine gelatin as the form of gelatin because Zydis tablets are commonly made with bovine gelatin. For example, 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 (Grother, Specification, ¶ 0160, Table 1).
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 claims 1, 5 and 7 above, one of ordinary skill in the art would have a reasonable expectation of success to use mannitol in a CBD Zydis wafer because it is commonly known in the art to formulate Zydis wafers with mannitol. For example, see the teachings of Grother and Monteith above.
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, ¶ 0145). For example, Monteith teaches that a 10 mg Claritin RediTab comprises 37.6% loratadine (API) (Monteith, Specification, p. 9, (¶ 0063), Table 3, shown above in the rejection of claim 1).
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 15 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 18 is directed towards the method of claim 15, 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, for example sucralose and acesulfame K because it is commonly known in the art to include such sweeteners in Zydis ODTs.
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). Suitable sweeteners include sucralose and acesulfame K (Grother, Specification, ¶ 0103).
Therefore, claims 15 and 18 were prima facie obvious at the time of filing.
Claim 19 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 19 was prima facie obvious at the time of filing.
Claim(s) 1-12, 15, and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over “Catalent to Partner with Ethicann on New Fast-Dissolve Cannabinoid-Based Treatment for Multiple Sclerosis Spasticity” (Catalent, p. 1-3, Dec. 3, 2019) (herein “Catalent”) (of record, cited in prior office action) in view of Grother et al. (US 2023/0364013 A1; published Nov. 16, 2023; effectively filed Oct. 8, 2020), Monteith et al. (US20080152712A1; published June 26, 2008) and Amipara & Gupta (Journal of Drug Delivery & Therapeutics; 2013, 3(1), 85-92), as applied to claims 1-9, 15 and 18-19 above, and further in view of Marco (CBD Mania, Jan. 26, 2021, pp. 1-16).
The rejection of claims 1-9, 15 and 18-19 above as unpatentable over Catalent in view of Grother, Monteith and Amipara is incorporated herein by reference.
Claim 10 is directed towards the method of claim 1, wherein the rapidly infusing composition is formulated with a solid form of the CBD. While Catalent does not teach that the Zydis CBD ODTs are formulated with a solid form of 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 solid/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, Amipara teaches that the ideal candidate for Zydis technology is a water insoluble compound with a particle size of less than 50 microns (e.g. it is a solid nanoparticle):
The freeze-drying technique has demonstrated improved absorption and increase in bioavailability. The Zydis formulations consist of a drug physically trapped in a water-soluble matrix (saccharine mixture and polymer), which is freeze dried to produce a product that dissolves rapidly when placed in mouth. The ideal candidate for Zydis technology should be chemically stable and water insoluble and particle size preferably less than 50 micron. Water soluble drugs might form eutectic mixtures and not freeze adequately, so dose is limited to 60 mg and the maximum drug limit is 400 mg for water insoluble drug as large particle sizes might present sedimentation problems during manufacture.
Amipara, p. 86-87.
CBD is an ideal candidate for Zydis technology because it is a water insoluble compound which can be readily extracted as a crystalline solid form which can be micronized for incorporation into the Zydis ODT. For example, Marco teaches crystalline CBD, a highly pure cannabidiol extract, which can be taken by a sublingual route (Marco, p. 3-5). Marco teaches that CBD crystals are very popular due to their versatility and ability to be incorporated into a variety of dosage forms:
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.
Therefore, claim 10 was prima facie obvious at the time of filing.
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.%.
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 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 it is commonly known in the art to formulate Zydis tablets with micronized APIs of this particle size. For example, 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). For example, Amipara teaches a particle size of less than 50 microns (Amipara, p. 86-87).
Therefore, claim 12 was prima facie obvious at the time of filing.
Claim(s) 1-9, 15, and 18-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over “Catalent to Partner with Ethicann on New Fast-Dissolve Cannabinoid-Based Treatment for Multiple Sclerosis Spasticity” (Catalent, p. 1-3, Dec. 3, 2019) (herein “Catalent”) (of record, cited in prior office action) in view of Grother et al. (US 2023/0364013 A1; published Nov. 16, 2023; effectively filed Oct. 8, 2020), Monteith et al. (US20080152712A1; published June 26, 2008) and Amipara & Gupta (Journal of Drug Delivery & Therapeutics; 2013, 3(1), 85-92), as applied to claims 1-9, 15 and 18-19 above, and further in view of Elliot et al. (Front. Immunol., 02 August 2018, Sec. Multiple Sclerosis and Neuroimmunology, Volume 9 – 2018, p. 1-12).
The rejection of claims 1-9, 15 and 18-19 above as unpatentable over Catalent in view of Grother, Monteith and Amipara is incorporated herein by reference.
Claim 20 is directed towards the method of claim 1, wherein the therapeutically effective amount of CBD is from 10 to 100 mg of CBD per dose.
While Catalent does not teach the therapeutically effective amount of CBD, one of ordinary skill in the art would have a reasonable expectation of success to include from 10 to 100 mg of CBD as the therapeutically effective dose because it is commonly known in the art that doses from 10 to 100 mg of CBD are therapeutically effective for autoimmune diseases.
For example, Elliot teaches that a therapeutically effective dose for multiple sclerosis is about 96 mg/day for a typical adult:
Multiple sclerosis (MS) is a chronic debilitating autoimmune disease without a cure. While the use of marijuana cannabinoids for MS has recently been approved in some countries, the precise mechanism of action leading to attenuate neuroinflammation is not clear. We used experimental autoimmune encephalomyelitis (EAE), a murine model of MS, to explore the anti-inflammatory properties of cannabidiol (CBD), a non-psychoactive cannabinoid. Treatment with CBD caused attenuation of EAE disease paradigms as indicated by a significant reduction in clinical scores of paralysis, decreased T cell infiltration in the central nervous system, and reduced levels of IL-17 and IFNγ.
Elliot, Abstract.
We chose to use a dose of 20 mg/kg body weight of CBD, which translates to 1.6 mg/kg when converted to human equivalent dose. This adds up to ~96 mg for an average human adult (60 kg).
Elliot, p. 8.
Therefore, claim 20 was prima facie obvious at the time of filing.
Claim 21 is directed towards the method of claim 1, wherein the rapidly infusing composition is administered to the subject 1 to 10 times per day.
While Catalent does not teach how many times per day to administer the rapidly infusing composition, one of ordinary skill in the art would have a reasonable expectation of success to administer the composition 1 to 10 times per day because these dosage regimens are commonly known in the art. For example, Elliot teaches that the CBD was administered daily in the mouse model (Elliot, col. 2, p. 3)
Therefore, claim 21 was prima facie obvious at the time of filing.
Claim(s) 1-9, 15, and 18-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over “Catalent to Partner with Ethicann on New Fast-Dissolve Cannabinoid-Based Treatment for Multiple Sclerosis Spasticity” (Catalent, p. 1-3, Dec. 3, 2019) (herein “Catalent”) (of record, cited in prior office action) in view of Grother et al. (US 2023/0364013 A1; published Nov. 16, 2023; effectively filed Oct. 8, 2020), Monteith et al. (US20080152712A1; published June 26, 2008) and Amipara & Gupta (Journal of Drug Delivery & Therapeutics; 2013, 3(1), 85-92), as applied to claims 1-9, 15 and 18-19 above, and further in view of Booz (Free Radical Biology and Medicine, Volume 51, Issue 5, 1 September 2011, Pages 1054-1061).
Claim 22 is directed towards the method of claim 1, wherein the autoimmune disease and/or inflammatory condition is a systemic autoimmune disease. Claim 23 is directed towards the method of claim 1, wherein the systemic autoimmune disease is rheumatoid arthritis.
Catalent teaches a CBD ODT for the treatment of the autoimmune disease multiple sclerosis. While Catalent does not teach that the autoimmune disease is a systemic autoimmune disease, or specifically rheumatoid arthritis, one of ordinary skill in the art would have a reasonable expectation of success to treat rheumatoid arthritis with the CBD composition because it is commonly known in the art to treat systemic autoimmune diseases such as arthritis with CBD. For example, Booz teaches that CBD may be an effective treatment for both multiple sclerosis and rheumatoid arthritis:
CBD may prove to have therapeutic utility in a number of conditions involving both inflammation and oxidative stress, including Parkinson disease, diabetes, rheumatoid arthritis, Alzheimer disease, and ischemia–reperfusion injury
Booz, col. 1, p. 1055;
As discussed by the authors [32], the lymphopenic effect of CBD was observed at a concentration shown to be efficacious in a number of animal models of neurodegenerative and inflammatory diseases, including blocking the progression of collagen-induced arthritis in a murine model of rheumatoid arthritis, decreasing damage to pancreatic islets in the nonobese diabetes-prone (NOD) mouse model of type 1 diabetes, lessening hyperalgesia in rat models of neuropathic and inflammatory pain, and preventing cerebral ischemia in gerbils.
Booz, col. 1, p. 1056;
Neuropathic pain is associated with microglia activation in the spinal cord and brain and their subsequent release of proinflammatory cytokines, such as interleukin-6 (IL-6), IL-1β, and TNFα [33]. The etiology of neuropathic pain, which is common in cancer, diabetes, multiple sclerosis, and peripheral nerve injury, is poorly understood, but recent evidence indicates that increased ROS generation by microglial cells is the critical initiating factor [34]. The drug Sativex, which consists of Δ9 -THC and CBD, is approved in several countries for treatment of central and peripheral neuropathic pain and for spasticity associated with multiple sclerosis [35]… The antinociceptive effects of CBD were associated with less of an increase in microglial density and p38 MAPK activity in the dorsal spinal cord. Finally, the anti-inflammatory and immunosuppressive actions of CBD may be of use in treating rheumatoid arthritis and the associated pain [37,38].
Booz, col. 2, p. 1056.
Therefore, claims 22-23 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. One of ordinary skill in the art would have no difficulty in obtaining a CBD Zydis ODT for the treatment of autoimmune conditions based on the teachings above.
Nonstatutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim(s) 1-12, 15 and 18-23 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 “Catalent to Partner with Ethicann on New Fast-Dissolve Cannabinoid-Based Treatment for Multiple Sclerosis Spasticity” (Catalent, p. 1-3, Dec. 3, 2019) (herein “Catalent”) (of record, cited in prior office action), Elliot et al. (Front. Immunol., 02 August 2018, Sec. Multiple Sclerosis and Neuroimmunology, Volume 9 – 2018, p. 1-12), and Booz (Free Radical Biology and Medicine, Volume 51, Issue 5, 1 September 2011, Pages 1054-1061).
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 1-12, 15 and 18 of the instant application and Catalent, Elliot and Booz teach how to apply such a composition for the treatment of autoimmune diseases including multiple sclerosis and rheumatoid arthritis, as shown in the 103 rejection above, incorporated herein by reference.
This is a provisional nonstatutory double patenting rejection.
Claim(s) 1-12, 15 and 18-23 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 “Catalent to Partner with Ethicann on New Fast-Dissolve Cannabinoid-Based Treatment for Multiple Sclerosis Spasticity” (Catalent, p. 1-3, Dec. 3, 2019) (herein “Catalent”) (of record, cited in prior office action), Elliot et al. (Front. Immunol., 02 August 2018, Sec. Multiple Sclerosis and Neuroimmunology, Volume 9 – 2018, p. 1-12), and Booz (Free Radical Biology and Medicine, Volume 51, Issue 5, 1 September 2011, Pages 1054-1061).
Although the claims at issue are not identical, they are not patentably distinct because the instant claims are directed towards a method of treating an autoimmune or inflammatory condition 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 for the treatment of autoimmune and inflammatory conditions, as shown by the teachings of Catalent, Elliot and Booz, whose teachings above are 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 autoimmune or inflammatory conditions as well.
Therefore, claims 1-12, 15 and 18-23 are rejected on the ground of nonstatutory double patenting.
Claim(s) 1-12, 15 and 18-23 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 “Catalent to Partner with Ethicann on New Fast-Dissolve Cannabinoid-Based Treatment for Multiple Sclerosis Spasticity” (Catalent, p. 1-3, Dec. 3, 2019) (herein “Catalent”) (of record, cited in prior office action), Elliot et al. (Front. Immunol., 02 August 2018, Sec. Multiple Sclerosis and Neuroimmunology, Volume 9 – 2018, p. 1-12), and Booz (Free Radical Biology and Medicine, Volume 51, Issue 5, 1 September 2011, Pages 1054-1061).
Although the claims at issue are not identical, they are not patentably distinct because the instant claims are directed towards a method of treating an autoimmune or inflammatory 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 for the treatment of autoimmune and inflammatory conditions, as shown by the teachings of Catalent, Elliot and Booz, whose teachings above are incorporated herein by reference, one of ordinary skill in the art would have a reasonable expectation of success to apply the composition recited in the claims of the copending application to the treatment of autoimmune or inflammatory conditions as well.
This is a provisional nonstatutory double patenting rejection.
Claim(s) 1-12, 15 and 18-23 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13, 16-22 and 28-34 of copending Application No. 18/252,668 in view of “Catalent to Partner with Ethicann on New Fast-Dissolve Cannabinoid-Based Treatment for Multiple Sclerosis Spasticity” (Catalent, p. 1-3, Dec. 3, 2019) (herein “Catalent”) (of record, cited in prior office action), Elliot et al. (Front. Immunol., 02 August 2018, Sec. Multiple Sclerosis and Neuroimmunology, Volume 9 – 2018, p. 1-12), and Booz (Free Radical Biology and Medicine, Volume 51, Issue 5, 1 September 2011, Pages 1054-1061).
Although the claims at issue are not identical, they are not patentably distinct because the instant claims are directed towards a method of treating an autoimmune or inflammatory disorder with an orally dispersible composition comprising cannabidiol, gelatin, and mannitol. The claims of the copending application are directed towards a method of treating Autism Spectrum Disorder in a subject with the same composition. Given that it was well known in the art to apply cannabidiol for the treatment of autoimmune and inflammatory conditions, as shown by the teachings of Catalent, Elliot and Booz, whose teachings above are incorporated herein by reference, one of ordinary skill in the art would have a reasonable expectation of success to apply the composition recited in the claims of the copending application to the treatment of autoimmune or inflammatory conditions as well.
This is a provisional nonstatutory double patenting rejection.
Claim(s) 1-12, 15 and 18-23 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 “Catalent to Partner with Ethicann on New Fast-Dissolve Cannabinoid-Based Treatment for Multiple Sclerosis Spasticity” (Catalent, p. 1-3, Dec. 3, 2019) (herein “Catalent”) (of record, cited in prior office action), Elliot et al. (Front. Immunol., 02 August 2018, Sec. Multiple Sclerosis and Neuroimmunology, Volume 9 – 2018, p. 1-12), and Booz (Free Radical Biology and Medicine, Volume 51, Issue 5, 1 September 2011, Pages 1054-1061).
Although the claims at issue are not identical, they are not patentably distinct because the instant claims are directed towards a method of treating an autoimmune or inflammatory 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 for the treatment of autoimmune and inflammatory conditions, as shown by the teachings of Catalent, Elliot and Booz, whose teachings above are incorporated herein by reference, one of ordinary skill in the art would have a reasonable expectation of success to apply the composition recited in the claims of the copending application to the treatment of autoimmune or inflammatory conditions as well.
This is a provisional nonstatutory double patenting rejection.
Claim(s) 1-12, 15 and 18-23 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 “Catalent to Partner with Ethicann on New Fast-Dissolve Cannabinoid-Based Treatment for Multiple Sclerosis Spasticity” (Catalent, p. 1-3, Dec. 3, 2019) (herein “Catalent”) (of record, cited in prior office action), Elliot et al. (Front. Immunol., 02 August 2018, Sec. Multiple Sclerosis and Neuroimmunology, Volume 9 – 2018, p. 1-12), and Booz (Free Radical Biology and Medicine, Volume 51, Issue 5, 1 September 2011, Pages 1054-1061).
Although the claims at issue are not identical, they are not patentably distinct because the instant claims are directed towards a method of treating an autoimmune or inflammatory 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 for the treatment of autoimmune and inflammatory conditions, as shown by the teachings of Catalent, Elliot and Booz, whose teachings above are incorporated herein by reference, one of ordinary skill in the art would have a reasonable expectation of success to apply the composition recited in the claims of the copending application to the treatment of autoimmune or inflammatory conditions as well.
This is a provisional nonstatutory double patenting rejection.
Claim(s) 1-12, 15 and 18-23 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 an autoimmune or inflammatory 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 for the treatment of autoimmune and inflammatory conditions, as shown by the teachings of Catalent, Elliot and Booz, whose teachings above are incorporated herein by reference, one of ordinary skill in the art would have a reasonable expectation of success to apply the composition recited in the claims of the copending application to the treatment of autoimmune or inflammatory conditions as well.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is found to be allowable.
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/HEATHER DAHLIN/Examiner, Art Unit 1629