DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-33, submitted on 7 November 2022, represent all claims currently under consideration.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Priority
This application is a 371 of PCT/EP2020/062086, filed 11 May 2020.
The effective filing date is 11 May 2020.
Information Disclosure Statement
One Information Disclosure Statement (IDS), submitted 20 November 2023, is acknowledged and has been considered.
Specification
The use of the term “KOLLIPHOR P188”, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 7 and 9 are objected to because of the following informalities: there is an extraneous “and” in the listing of symptoms. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims does/do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to a natural product (cannabidiol) without significantly more. The claims recite “a cannabinoid for the treatment of a patient suffering from an infection with SARS-CoV-2” and specifies that the cannabinoid is cannabidiol (CBD) in Claim 2. CBD is a natural product, and the intended use language of the claim does not result in a structural difference between the natural product CBD and what is claimed; the claim is written in such a way that the natural product CBD is claimed. This judicial exception is not integrated into a practical application because the intended use of the claim does not result in a structural difference between what is claimed and the natural product itself, and as the natural product CBD meets the limitations of what is claimed, it necessarily must function in the same manner. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims are directed to CBD directly.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 18 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Factors to be considered
in making the determination as to whether one skilled in the art would recognize that
applicant was in possession of the claimed invention as a whole at the time of filing
include : (a) Actual reduction to practice; (b) Disclosure of drawings of structural
chemical formulas; (c) Sufficient identifying characteristics such as: (i) Complete structure, (ii) Partial structure, (iii) Physical and/or chemical properties or (iv) Functional
characteristics when coupled with a known or disclosed correlation between function
and structure; (d) Method of making the claimed invention; (e) Level of skill and
knowledge in the art and (f) Predictability in the art. While all of these factors are
considered, a sufficient number for a prima facie case are discussed below:
Claim 18 is directed to the cannabinoid according to claim 1, wherein the cannabinoid is applied in combination with a drug against idiopathic pulmonary fibrosis; or in combination with a drug against blood clots or a drug against cardiac arrhythmias. The specification does not provide a representative class of compounds or structure that can be used as a drug against idiopathic pulmonary fibrosis, blood clots, or cardiac arrhythmias. The specification does not describe these compounds other than what they accomplish when administered to the patient. The artisan would only be able to determine what compounds fall within each of those classes from a posteriori testing and analysis, and would not be able to know prior to using the compound in conjunction with CBD if the compound will perform as claimed. There is no specific core structure or class of compounds defined that will provide the basis for the breadth of the claims. The artisan would generally understand what each compound functionally does, but without specific guidance from the specification as to what compounds or classes of compounds can be used as claimed in the invention, there would be no expectation of predictability for practicing this invention. Thus, there is no support in the specification that applicant was in possession of the claimed invention as a whole at the time of filing.
Claim Rejections - 35 USC § 112(b)
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.
Claim 6 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The term “non-severe symptomatic period” is defined in the specification as “virus detectable” (Page 3). However, this is a relative term as “non-severe” is not defined, and can encompass a broad range of symptoms. What defines when the patient has moved from the non-severe symptomatic period to the severe respiratory symptomatic stage (Stage II to Stage III)? There are no criteria defined in the specification that would guide the artisan to know when this has occurred, rendering the metes and bounds of the claims undefined, and therefore, indefinite.
Claim 17 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Regarding claim 17, the phrase "in particular " renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 33 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The claim is indefinite because it is not clear how “and” in the term “and/or” modifies the claim. It is unclear if the term “and” is suggesting wherein all requirements are met. If this is not the case then it is not clear how the term “and” differs from the term “or”.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 24-33 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 24-33 depend on Claim 1, which claims a cannabinoid. Claims 24-33 are directed to a composition, which is broader than Claim 1, which only claims a cannabinoid, and thus these claims are not further limiting. Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims comply with the statutory requirements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang (Preprints, doi:10.20944/preprints202004.0315.v1, Posted: 19 April 2020).
Wang (See IDS, 20 November 2023) provides an analysis of the relationship between cannabidiol use and modulation of expression of the receptor angiotensin-converting enzyme II (ACE2), which the SARS-CoV2 virus uses to gain entry into cells. Wang discloses a cannabinoid (cannabidiol) that can be used for the treatment of a patient suffering from an infection with SARS-CoV-2. As the claims are written with intended use language, the limitations which follow “the cannabinoid” in each claim does not result in a structural difference from what is taught by Wang. The prior art structure is capable of performing the intended use, meeting the limitations of the claim (See MPEP § 2112.02 (II)).
Claims 1-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Byrareddy (Brain Behav. Immun, 2020 April 28; 87:120-121).
Byrareddy (See IDS, 20 November 2023) provides a review of the use of cannabinoids to treat SAR-CoV2 induced respiratory distress. Byrareddy discloses a cannabinoid (cannabidiol) that can be used for the treatment of a patient suffering from an infection with SARS-CoV-2. As the claims are written with intended use language, the limitations which follow “the cannabinoid” in each claim does not result in a structural difference from what is taught by Byrareddy. The prior art structure is capable of performing the intended use, meeting the limitations of the claim (See MPEP § 2112.02 (II)).
Claims 1-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mamber (Preprints, 27 April 2020).
Mamber (See IDS, 20 November 2023) describes four unconventional but commercially accessible immunomodulatory agents that could be employed in clinical trials to evaluate their effectiveness at alleviating disease symptoms and severity: low dose oral interferon-α, microdose DNA, low-dose thimerosal, and phytocannabinoids (Abstract). Phytocannabinoids such as cannabidiol (CBD) have been shown to inhibit inflammatory and Th1 cytokines, and promote an anti-inflammatory and Th2 immune response both in vitro and in vivo. Mamber discloses a cannabinoid (cannabidiol) that can be used for the treatment of a patient suffering from an infection with SARS-CoV-2. As the claims are written with intended use language, the limitations which follow “the cannabinoid” in each claim does not result in a structural difference from what is taught by Mamber. The prior art structure is capable of performing the intended use, meeting the limitations of the claim (See MPEP § 2112.02 (II)).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-29 are rejected under 35 U.S.C. 103 as being unpatentable over Byrareddy (Brain Behav. Immun, 2020 April 28; 87:120-121) in view of Faraci (WO 2018/152334; Publication Date: 23 August 2018).
Byrareddy, as described previously, teaches that the cannabinoid CBD has promise as a treatment of COVID-19 due to its immunomodulatory capabilities and states that its use in conjunction with remdesivir should be explored and considered.
Byrareddy does not disclose formulations of cannabidiol.
Faraci discloses cannabinoid formulations, including self-emulsifying formulations and micellar dispersions as well as methods of making and using the same. The formulations comprise a cannabinoid and surfactant. The invention provides for formulations comprising at least one active ingredient, including self-emulsifying formulations and micellar dispersions, as well as methods of making and using the same. The formulations comprise at least one active ingredient and surfactant (Abstract). The present invention relates to compositions comprising at least one active ingredient, e.g., a cannabinoid, cannabinoid extract, terpene, terpene extract, or other active ingredient and surfactant. The compositions include self-emulsifying formulations and formulations that form micelle solution/dispersions (Page 1, Lines 8-10). In one embodiment, the at least one active ingredient is selected from a cannabinoid, cannabinoid extract, terpene, or terpene extract. In another embodiment, the composition is a non-aqueous formulation. In another embodiment, the composition is a pharmaceutical composition, preferably an oral dosage form, more preferably a solid or semi-solid oral dosage form (Page 3, Lines 5-9). A composition of the present invention may further comprise an additional surfactant, antioxidant, viscosity modifying agent, cytochrome P450 metabolic inhibitor, P-GP efflux inhibitor, or semi-solid inducer. Viscosity modifying agents include… hydroxymethylpropyl cellulose…(Page 44, Lines 4-15). In one embodiment, the composition comprises a cannabinoid or cannabinoid extract and a surfactant. The compositions of the present invention form emulsions, preferably nanoemulsions, microemulsions, or micelle dispersions in an aqueous solution (Page 11, Lines 23-27). In some embodiments, the surfactant is selected from… polyethylene-polypropylene glycol (poloxamer 188)… hydroxypropyl methylcellulose (HPMC)… or a combination thereof (Page 14, Lines 12-25). In compositions of the present invention are preferably for oral administration (Page 33, Line 15). In one embodiment, the composition of the present invention is self-emulsifying in an aqueous solution. In a further embodiment, the composition forms a micellar dispersion in an aqueous solution (Page 34, Lines 23-25). In an embodiment of the invention, the cannabinoid is THC or CBD (Page 42, Line 8).
Byrareddy and Farci are considered analogous to the claimed invention as all are involved in the therapeutic application of cannabinoids, in particular, cannabidiol. Therefore, it would have been prima facie obvious to one of ordinary skill in the art the time of the effective filing date of the instant application to apply the formulations of cannabidiol disclosed by Farci for the treatment of COVID-19, as taught by Byrareddy, arriving at the claimed invention. The application formulation of CBD, and subsequent application for the treatment of COVID-19 is prima facie obvious combination of prior art elements according to known methods to yield predictable results (See MPEP § 2143 I (A)); Byrareddy discloses a cannabinoid (CBD), while Farci discloses formulations of CBD which meet the limitations of those claimed; the artisan would recognize this, and would be motivated to combine these teachings as the formulations of Farci provided improved pharmacokinetic properties; CBD is highly lipophilic and poorly water soluble. The formulations disclosed by Farci lead to improved solubility, allowing for more consistent dosing and improved therapeutic outcomes for the patient in need of treatment.
Regarding Claims 1-29, the claims are written with intended use language; the limitations which follow “the cannabinoid” in each claim does not result in a structural difference from what is taught by Byrareddy. The prior art structure is capable of performing the intended use, meeting the limitations of the claim (See MPEP § 2112.02 (II)).
Regarding Claim 29, Farci does not explicitly demonstrate that their particles will perform as described in the claim. However, the examples provided (Tables 3, 4, 5, 6 and 7) demonstrate that the alteration of the concentrations and ratios of the various components of the formulation alter the solubility and other performance characteristics of said formulation. It flows from the art that these parameters could be adjusted within routine experimentation and optimization that is normally done during formulation work to arrive at a formulation that performs as claimed in Claim 29 (See MPEP § 2144.05 II (A)); the artisan would be motivated to perform this optimization in order to develop a formulation with an improved dissolution profile, allowing for more rapid delivery of the therapeutic.
Claims 1-33 are rejected under 35 U.S.C. 103 as being unpatentable over Byrareddy (Brain Behav. Immun, 2020 April 28; 87:120-121) in view of Nowak (WO 2020/016653; Publication Date: 23 January 2020).
Byrareddy, as described previously, teaches that the cannabinoid CBD has promise as a treatment of COVID-19 due to its immunomodulatory capabilities and states that its use in conjunction with remdesivir should be explored and considered.
Byrareddy does not disclose formulations of cannabidiol.
Nowak discloses compositions for the extended release of one or more cannabinoids, in which the compositions comprise a population of particles. Each particle may comprise the one or more cannabinoids, one or more drug-releasing agents, and a core. The APIs may be a cannabinoid, such as CBD or THC. The core may comprise an inert material. The one or more cannabinoids may comprise THC, cannabidiol, or a combination thereof (Abstract). The invention provides multi-particulate solid oral dosage forms comprising one or more cannabinoids. These dosage forms can be administered as capsules, tablets (regular tablets, orally-disintegrating tablets, self-disintegrated tablets, chewable tablets), sachets, sprinkles, or stick pack. The system may comprise particles having a size that may range from about 30µm to about 1500 µm (Paragraph 0017). In some embodiments, the core may comprise an inert material selected from the group consisting of microcrystalline cellulose, celluloses, starches, saccharides, and mixtures thereof. In some embodiments, the core may comprise a coating that comprises one or more cannabinoids and the one or more drug-releasing agents. In certain embodiments, the core may comprise a coating that comprises the one or more cannabinoids, the one or more drug releasing agents, the one or more solubilizers, and the one or more surfactants (Paragraph 0021). In some embodiments, the one or more surfactants in the compositions of the invention may comprise… poloxamers…(Paragraph 0047). The compositions of the present invention may further comprise one or more stabilizing agents, including tocopherols, ascorbic acid, butylated hydroanisole, and other antioxidants (Paragraph 0048). Examples of binders include but are not limited to hydroxypropylmethyl cellulose (Paragraph 0051). According to embodiments of the present invention, compositions comprising one or more cannabinoids according to the present invention may be prepared by dispersing the one or more cannabinoids in one or more solubilizers (such as an ethanol and water mixture) along with one or more drug-releasing agents (such as one or more release-controlling polymers and/or one or more release-accelerating polymers) (and optionally one or more stabilizing agents), and the drug dispersion may then be applied onto cores (such as microcrystalline cellets or sugar spheres). According to these embodiments, the one or more cannabinoids may be mixed in the one or more solubilizers to form a homogenous dispersion. The one or more drug-releasing agents (e.g., one or more release-controlling polymers and/or one or more release-accelerating polymers) (and optionally one or more stabilizing agents) may be then mixed with the dispersion using, for example, a vortex mixer, until a homogenous mixture is formed. The mixture may be then loaded onto the cores. In some embodiments, the mixture may be sprayed onto the cores using, for instance, a fluid bed processor. The particle size and size distribution of the cores can be narrowed/adjusted to achieve uniform drug distribution and targeted delivery profile (Paragraph 0060).
Byrareddy and Nowak are considered analogous to the claimed invention as all are involved in the therapeutic application of cannabinoids, in particular, cannabidiol. Therefore, it would have been prima facie obvious to one of ordinary skill in the art the time of the effective filing date of the instant application to apply the formulations of cannabidiol disclosed by Nowak for the treatment of COVID-19, as taught by Byrareddy, arriving at the claimed invention. The application formulation of CBD, and subsequent application for the treatment of COVID-19 is prima facie obvious combination of prior art elements according to known methods to yield predictable results (See MPEP § 2143 I (A)); Byrareddy teaches the use of CBD for the treatment of COVID-19, while Nowak discloses formulations of CBD which meet the limitations of those claimed; the artisan would recognize this, and would be motivated to combine these teachings as the formulations of Nowak provided improved pharmacokinetic properties; CBD is highly lipophilic and poorly water soluble. The formulations disclosed by Nowak lead to improved solubility, allowing for more consistent dosing and improved therapeutic outcomes for the patient in need of treatment.
Regarding Claims 1-33, the claims are written with intended use language; the limitations which follow “the cannabinoid” in each claim does not result in a structural difference from what is taught by Byrareddy. The prior art structure is capable of performing the intended use, meeting the limitations of the claim (See MPEP § 2112.02 (II)).
Regarding Claims 29 and 33, Nowak does not explicitly disclose formulations which have the dissolution parameters as claimed. However, Figures 3A, 3B, 4A, 4B, 5A, and 5B demonstrate that the release profile of the formulations of the invention, demonstrating that by altering the ratios of various components, the release rate of the cannabinoid can be altered. It flows from the art that these parameters could be adjusted within routine experimentation and optimization that is normally done during formulation work to arrive at a formulation that performs as claimed in Claim 29 (See MPEP § 2144.05 II (A)); the artisan would be motivated to perform this optimization in order to develop a formulation with an improved dissolution profile, allowing for more rapid delivery of the therapeutic.
Regarding Claims 30 and 32, the optimization of the amounts and ratios of excipients such as the film former can be determined through routine experimentation that is done during formulation work, as is standard during the development of an extended release formulation. Determining the exact ratio of the excipients in the formulation is prima facie routine optimization through routine experimentation (See MPEP § 2144.05 II (A)); the artisan would be motivated to perform this optimization in order to develop a formulation with an improved dissolution profile, allowing for more rapid delivery of the therapeutic.
Claims 1-33 are rejected under 35 U.S.C. 103 as being unpatentable over Byrareddy (Brain Behav. Immun, 2020 April 28; 87:120-121) in view of Temtsin-Krayz (WO 2017/072774; Publication Date: 4 May 2017)
Byrareddy, as described previously, teaches that the cannabinoid CBD has promise as a treatment of COVID-19 due to its immunomodulatory capabilities and states that its use in conjunction with remdesivir should be explored and considered.
Byrareddy does not disclose formulations of cannabidiol.
Temtsin-Krayz discloses a pharmaceutical composition for transmucosal administration of an active lipophilic compound through the oral mucosa comprising a lipophilic active compound, a polymeric matrix formed by two or more water soluble polymers, and a rapid dissolution agent. At least one of the water-soluble polymers is an amphiphilic polymer and at least one is either a hydrophilic polymer or an amphiphilic polymer (Abstract). In a specific embodiment, the lipophilic active compound is a cannabinoid selected from THC and CBD (Paragraph 0013). The pharmaceutical composition of an embodiment of the present application contains the amphiphilic polymer selected from the group consisting of… poloxamers… (Paragraph 0015). In a further embodiment, the transmucosal pharmaceutical composition contains the hydrophilic polymer selected from the group consisting of sodium carboxymethyl cellulose, hydroxyethylcellulose, polyvinyl alcohol, sodium alginate, chitosan, and carrageenan (Paragraph 0016). In a further embodiment, the amphiphilic polymer may be poloxamers…Hypromellose (also known as hydroxypropyl methyl cellulose)… (Paragraph 0033). The pharmaceutical composition of an embodiment may further comprise one or more pharmaceutically acceptable carriers or excipients. The composition may be prepared in a form of a powder, powder microsphere, coated powder microspheres, liposomal dispersions, and combinations thereof. It may be formulated into a dosage form for oral administration selected from capsules, tablets, beads, grains, pills, granulates, granules, powder, pellets, sachets, troches, disks, films, oral suspensions, and aerosol (Paragraph 0019). Exemplary embodiments have the following combinations of polymers, such as three polymers to form the polymeric matrix, two of the polymers being amphiphilic polymers, preferably poloxamer 407 and PVP, and the other polymer being a hydrophilic polymer preferably NaCMC (Paragraph 0035). An exemplary pharmaceutical composition of the application includes cannabidiol, poloxamer 407 NaCMC, and mannitol (Paragraph 0036). It would be within the parameters of what is disclosed to include hypromellose (hydroxypropyl methyl cellulose) within the formulation, and the artisan could arrive at the use of poloxamer 188 through routine experimentation in order to optimize solubilization and dissolution of the pharmaceutical formulation of cannabidiol.
Byrareddy and Temtsin-Krayz are considered analogous to the claimed invention as all are involved in the therapeutic application of cannabinoids, in particular, cannabidiol. Therefore, it would have been prima facie obvious to one of ordinary skill in the art the time of the effective filing date of the instant application to apply the formulations of cannabidiol disclosed by Temtsin-Krayz for the treatment of COVID-19, as taught by Byrareddy, arriving at the claimed invention. The application formulation of CBD, and subsequent application for the treatment of COVID-19 is prima facie obvious combination of prior art elements according to known methods to yield predictable results (See MPEP § 2143 I (A)); Byrareddy teaches the use of CBD for the treatment of COVID-19, while Temtsin-Krayz discloses formulations of CBD which meet the limitations of those claimed; the artisan would recognize this, and would be motivated to combine these teachings as the formulations of Temtsin-Krayz provided improved pharmacokinetic properties; CBD is highly lipophilic and poorly water soluble. The formulations disclosed by Temtsin-Krayz lead to improved solubility and enhanced permeability across the oral mucosa, allowing for more consistent dosing and improved therapeutic outcomes for the patient in need of treatment.
Regarding Claims 1-33, the claims are written with intended use language; the limitations which follow “the cannabinoid” in each claim does not result in a structural difference from what is taught by Byrareddy. The prior art structure is capable of performing the intended use, meeting the limitations of the claim (See MPEP § 2112.02 (II)).
Regarding Claims 29 and 33, Temtsin-Krayz does not explicitly disclose formulations which have the dissolution parameters as claimed. However, Table 7 and Figure 5 demonstrate that the release profile of a formulation of cannabidiol compared to unformulated cannabidiol in fasted state simulated intestinal fluid, demonstrating that by altering the ratios of various components, the release rate of the cannabinoid can be altered. It flows from the art that these parameters could be adjusted within routine experimentation and optimization that is normally done during formulation work to arrive at a formulation that performs as claimed in Claim 29 (See MPEP § 2144.05 II (A)); the artisan would be motivated to perform this optimization in order to develop a formulation with an improved dissolution profile, allowing for more rapid delivery of the therapeutic.
Regarding Claims 30 and 32, the optimization of the amounts and ratios of excipients such as the film former can be determined through routine experimentation that is done during formulation work, as is standard during the development of an extended-release formulation. Determining the exact ratio of the excipients in the formulation is prima facie routine optimization through routine experimentation (See MPEP § 2144.05 II (A)); the artisan would be motivated to perform this optimization in order to develop a formulation with an improved dissolution profile, allowing for more rapid delivery of the therapeutic.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 6, 13-16, and 18-31 of copending Application No. 17/923,749 (‘749) (Amended Claims of 7 November 2022).
Claim 1 of ‘749 claims a cannabinoid for treatment of a patient suffering from an inflammatory condition characterized by elevated IL-6 levels. Claim 2 claims the cannabinoid of claim 1 wherein the cannabinoid is cannabidiol. Claim 5 claims that the patient suffers from an inflammatory condition in connection with an infection. Claim 6 claims the cannabinoid according to claim 5 wherein the treatment is for preventing or ameliorating cytokine release syndrome. Claim 13 claims the cannabinoid according to Claim 1 wherein the treatment reduces serum IL-6 levels. Claims 14, 15, and 16 have diagnostic criteria for treatment which are identical to those of Claims 13 and 15 of the examined application. Claim 18 claims the cannabinoid according to claim 1 wherein the cannabinoid is administered orally. Claims 19-22 claim the dosages of the cannabinoid, which overlaps with those claimed in the examined application. Claim 23 claims that the cannabinoid is formulated as a solid dispersion. Claim 24 claims the cannabinoid of Claim 23 wherein the solid dispersion comprises the cannabinoid and a solubilizer which is an amphiphilic block copolymer capable of forming a micellar solution if combined with an aqueous medium. Claim 25 claims the cannabinoid of claim 23 wherein the solubilizer is a block copolymer containing at least one polyoxyethylene block and at least one polyoxypropylene block. Claim 26 claims the cannabinoid according to claim 25 wherein the solubilizer is a poloxamer, and claim 27 claims the cannabinoid according to claim 26 herein the formulation comprises cannabidiol as the active substance, poloxamer 188 as the solubilizer, and optionally an antioxidant. Claim 28 claims the cannabinoid according to claim 23 wherein the formulation, when subjected to an in vitro dissolution test in 0.1N HCl following the USP paddle method, releases at least 60 wt% of the cannabinoid within 60 minutes. Claim 29 claims the cannabinoid according to claim 1 wherein the cannabinoid is incorporated in a formulation comprising a core and a coating on the core, wherein the coating comprises the cannabinoid, one or more water-soluble film formers, and not more than 20 wt% based on the weight of all components, other excipients. Claim 30 claims the cannabinoid according to claim 29 wherein HPMC is used as the water-soluble film former. Claim 31 claims the cannabinoid according to claim 29 wherein the film former/formers, based on the total amount of cannabinoid, are comprised in a total proportion of 0.3-10 wt%. Claim 32 claims the cannabinoid according to claim 29 wherein more than 30 wt% and less than 8- wt% of the cannabinoid is released within two hours; and/or wherein more than 40 wt% and less than 90 wt% of the cannabnoind is released within three hours; and/or wherein more than 50 wt% and less than 95 wt% of the cannabinoid contained is released within four hours.
The claims are not patentably distinct because COVID-19 is an inflammatory condition that is characterized by, among other manifestations, elevated IL-6 levels. As the claims are written with intended use language, the limitations which follow “the cannabinoid” in each claim does not result in a structural difference from what is claimed in ‘749. The prior art structure is capable of performing the intended use, meeting the limitations of the claim (See MPEP § 2112.02 (II)).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28, 33, 35, 36, 39, 54, 55, 56, and 57 of copending Application No. 17/923,754 (‘754) (Amended claims of 7 November 2022).
Claim 1 of ‘754 claims a cannabinoid for treatment of a patient suffering from infection with SARS-CoV-2 or of a subject at risk to be infected with SARS-CoV-2. Claim 2 claims the cannabinoid of claim 1 wherein the cannabinoid is CBD. Claim 3 claims the cannabinoid according to claim 1 wherein the treatment is for preventing or ameliorating cytokine release syndrome and/or reducing viral load. Claim 4 claims the cannabinoid of claim 3 wherein the treatment is for preventing or ameliorating cytokine release syndrome. Claim 5 claims the cannabinoid of claim 1 wherein the treatment reduces IL-6 serum levels. Claim 6 claims the cannabinoid of claim 1, wherein the treatment is for preventing or ameliorating ARDS. Claim 7 claims the cannabinoid according to claim 1 wherein the treatment is initiated during the non-severe symptomatic period. Claims 8-18 claim the cannabinoid according to claim 1 wherein the treatment is initiated if the patient meets diagnostic criteria identical to those claimed in the examined application. Claim 19 claims the cannabinoid according to claim 1 wherein the cannabinoid is administered with one or more antiviral agents, including remdesivir. Claim 20 claims the cannabinoid according to claim 1 wherein the cannabinoid is administered orally. Claims 21-24 claims the cannabinoid according to claim 1 with dosing that is identical to that claimed in the examined application. Claim 25 claims the cannabinoid according to claim 1 wherein the cannabinoid is formulated as a solid dispersion. Claims 26-28 claim the cannabinoid according to claim 25 wherein the solid dispersion comprises the cannabinoid and a solubilizer capable of forming a micellar solution, and the solubilizer is a poloxamer, particularly poloxamer 188. Claim 33 claims the cannabinoid according to claim 25 wherein the solid comprises a cannabinoid, amphiphilic block copolymer and a water-soluble film former. Claim 35 claims the cannabinoid according to claim 33 wherein the amphiphilic block copolymer is a block copolymer containing at least one polyoxyethylene block and at least one polyoxypropylene block. Claim 36 claims the cannabinoid according to claim 35 wherein the amphiphilic block copolymer is a poloxamer, in particular, poloxamer 188. Claim 39 claims the cannabinoid according to claim 33 wherein the water-soluble film former is hydroxypropyl methyl cellulose. Claim 54 claims the cannabinoid according to claim 1 wherein the cannabinoid is incorporated in a formulation comprising a core and a coating on the core, wherein the coating comprises the cannabinoid, one or more water-soluble film formers and not more than 20 wt% based on the weight of all components, other excipients. Claim 55 claims the cannabinoid according to claim 54 wherein HPMC is used as the film former. Claim 56 claims the cannabinoid according to claim 54 wherein the film former/formers, based on the total weight of cannabinoid, is/are comprised in a total proportion of 0.3-10wt%. Claim 57 claims the cannabinoid according to claim 54 wherein more than 30 wt% and less than 8- wt% of the cannabinoid is released within two hours; and/or wherein more than 40 wt% and less than 90 wt% of the cannabinoid is released within three hours; and/or wherein more than 50 wt% and less than 95 wt% of the cannabinoid contained is released within four hours.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, 6, 13-26, 31, 33, 34, and 52-55 of copending Application No. 17/923,786 (‘786) (Amended Claims of 7 November 2022).
Claim 1 of ‘786 claims a cannabinoid for treatment of a patient suffering from an inflammatory condition characterized by elevated IL-6 levels or being at risk of suffering from such conditions. Claim 2 claims the cannabinoid according to claim 1 wherein the cannabinoid is CBD. Claim 5 claims the cannabinoid according to claim 1 wherein the patient suffers from an inflammatory condition in connection with an infection. Claim 6 claims the cannabinoid according to claim 5 wherein the treatment is for preventing or ameliorating cytokine release syndrome. Claim 13 claims the cannabinoid according to claim 1 wherein the treatment reduces the serum IL-6 level. Claims 14-17 claims the cannabinoid according to claim 1 wherein the treatment occurs if diagnostic criteria are met which are identical to those claimed in the examined application. Claim 18 claims the cannabinoid according to claim 1 wherein the cannabinoid is administered orally. Claims 19-22 claims the cannabinoid according to claim 1 wherein there are dosing patterns identical to those claimed in the examined application. Claim 23 claims the cannabinoid according to claim 1 wherein the cannabinoid is formulated as a solid dispersion. Claim 24 claims the cannabinoid according to claim 23 wherein the solid dispersion comprises the cannabinoid and a solubilizer which is an amphiphilic block copolymer capable of forming a micellar solution if combined with an aqueous medium. Claim 25 claims the cannabinoid according to claim 23 wherein the solubilizer is a block copolymer containing at least one polyoxyethylene block and at least one polyoxypropylene block. Claim 26 claims the cannabinoid according to claim 25 wherein the solubilizer is a poloxamer, in particular poloxamer 188. Claim 31 claims the cannabinoid according to claim 23 wherein the solid dispersion comprises a cannabinoid, an amphiphilic block copolymer and a water soluble film former. Claim 33 claims the cannabinoid according to claim 31 wherein the amphiphilic block copolymer is a block copolymer containing at least one poolyoxyethylene block and at least one polyoxypropylene block, and Claim 34 specifies that it is polyoxamer 188. Claim 52 claims the cannabinoid according to claim 1 wherein the cannabnoind is incorporated in a formulation comprising a core and a coating on the core, wherein the coating comprises the cannabinoid, one or more water-souble film formers and not more than 20 wt% based on the weight of all components, of other excipients. Claim 53 claims the cannabinoid according to claim 52 wherein HPMC is used as the water soluble film former. Claim 54 claims the cannabinoid according to claim 52 wherein the film former/formers based on the total amount of cannabinoid, is/are comrpsied in a total proportion of 0.3-10 wt%. Claim 55 claims the cannabinoid according to claim 52 wherein more than 30 wt% and less than 8- wt% of the cannabinoid is released within two hours; and/or wherein more than 40 wt% and less than 90 wt% of the cannabnoind is released within three hours; and/or wherein more than 50 wt% and less than 95 wt% of the cannabinoid contained is released within four hours.
The claims are not patentably distinct because COVID-19 is an inflammatory condition that is characterized by, among other manifestations, elevated IL-6 levels. As the claims are written with intended use language, the limitations which follow “the cannabinoid” in each claim does not result in a structural difference from what is claimed in ‘749. The prior art structure is capable of performing the intended use, meeting the limitations of the claim (See MPEP § 2112.02 (II)).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3 of copending Application No. 18/287,096 (‘096) (Amended Claims of 12 August 2024) in view of Byrareddy (Brain Behav. Immun, 2020 April 28; 87:120-121).
Claim 1 of ‘096 is directed to a pharmaceutical formulation in the form of a solid dispersion wherein the solid dispersion comprises in admixture a cannabinoid, an amphiphilic block copolymer as a solubilizer, and a water-soluble film former, wherein the components are present in a weight ratio cannabinoid: amphiphilic block copolymer: water soluble film former ratio of 1: 0.11-0.41:0.03-0.33. Claim 3 is directed to the formulation of claim 1 wherein the amphiphilic block copolymer is a block copolymer containing at least one polyoxyethylene block and at least one polyoxypropylene block, wherein the amphiphilic block copolymer preferably is a poloxamer, in particular poloxamer 188.
‘096 does not claim that the cannabinoid is CBD.
Byrareddy, as described previously, teaches that the cannabinoid CBD has promise as a treatment of COVID-19 due to its immunomodulatory capabilities and states that its use in conjunction with remdesivir should be explored and considered.
Byrareddy and ‘096 are considered analogous to the claimed invention as all are involved in the pharmaceutic