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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 22 July 2025 has been entered.
Claim Status
Applicant’s claim amendments and arguments in the response filed 22 July 2025 are acknowledged.
Claims 1-6, 12-24, 36, 37, 40-44, 46 & 47 are pending.
No claims are withdrawn.
Claim 47 is new.
Claims 7-11, 25-35, 38, 39 & 45 are cancelled.
Claims 1 & 40 are amended.
Claims 1-6, 12-24, 36, 37, 40-44, 46 & 47 are under consideration.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied and constitute the complete set presently being applied to the instant application.
Examination on the merits is extended to the extent of the following species:
Cannabinoid-cannabidiol (CBD);
Poloxamer- poloxamer 124; and
Solvent- triethyl citrate.
Priority
` Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file. The effective filing date of the instant application is 01 July 2016 based upon the English language foreign priority document.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 22 July 2025 has been fully considered by the examiner. A signed and initialed copy of each IDS is included with the instant Office Action.
New and Maintained Objections/ Rejections
Specification
The disclosure is objected to because of the following:
For the definition of R3 on page 4, the recited substituent "CH2C(O)CH2CH3" appears to be a typographical error for the intended substituent "CH2C(O)OCH2CH3". Indeed, the elected species of solvent is "triethyl citrate", and as presented, the definition of the solvent of formula (I) does not include all the appropriate substituents needed to arrive at triethyl citrate. One could arrive at triethyl citrate, however, if R3 is "CH2C(O)OCH2CH3". Since the specification expressly discloses that the solvent can be triethyl citrate, amending the specification to read that R3 can be "CH2C(O)OCH2CH3", rather than "CH2C(O)CH2CH3", would be treated as correcting an obvious typographical error and not adding new matter. However, Applicant is advised to also carefully review the definition of the solvent of formula (I), and fix any other discrepancies between the definition of the solvent of formula (I) and the actual solvents enumerated in the specification, e.g. diacetin, propylene glycol, triacetin, monoacetin, propylene glycol diacetate, etc.
Appropriate correction is required.
Claim Objections
Claims 15, 40 & 44 are objected to because of the following informalities: Claim 14 defines the abbreviation for each of the recited cannabinoids. Claims 15 & 44 recite both the species of cannabinoid and the abbreviation; the abbreviation should only be used in claims 15 & 44 since claim 14 has already defined them.
Claim 40 recites “wherein the the at least one poloxamer…”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 1-6, 12-24, 36, 37, 40-44, 46 & 47 are 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. This is a new matter rejection. Claim 1 recites a formulation comprising at least one cannabinoid, at least one poloxamer which is at least one of poloxamer 188 and poloxamer 124, and a solvent wherein the solvent is diacetin, propylene glycol, triacetin, monoacetin, propylene glycol diacetate, triethyl citrate or mixtures thereof. Claim 1 recites the formulation is substantially alcohol-free and is homogenous. In the reply filed on 22 July 2025, Applicant’s representative states support is present throughout the specification (reply, pg. 8). This is not persuasive. The concept of homogeneity is addressed on page 19 of the specification in which the formulation is rehydrated with 20 ml of water. However, the instant claims contain no limitations pertaining to the rehydration in water. The concept of a homogenous gel is disclosed in the Example on page 23 of the specification but this is a specific formulation comprising CBD as the cannabinoid, both poloxamers 188 and 124, and diacetin as the solvent. However the claims are generic to the form of formulation (i.e. it is not required to be a gel), generic to the cannabinoid, and generic to the solvent. The concept of the formulation being homogenous when the formulation comprises any cannabinoid, at least one of poloxamer 188 or 124, and the any of the species of the recited genera of solvent is not present. The claim changes the scope of the disclosure; thereby constituting new matter.
Claims 2-6, 12-24, 36, 37, 40-44, 46 & 47 are rejected under 35 USC 112(a)-NEW MATTER because they ultimately depend from claim 1 and do not rectify the issue.
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.
Claims 19 and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 19 and 20 recite “alpha-tocopherol (Vitamin E)”. There are 8 different types of Vitamin E, of which alpha-tocopherol is one. It is unclear whether Applicant is claiming alpha-tocopherol (i.e. a species) or the genus of Vitamin E.
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.
Claims 1-6, 12-24, 36, 37, 40-44, 46 & 47 are rejected under 35 U.S.C. 103 as being unpatentable over Goskonda [(US 2014/0100269; Published: 04/10/2014; IDS-06/30/2017); as evidenced by Poloxamer (Published: 11/06/2002; previously cited); and as evidenced by Bergeron (US 2015/0080443; previously cited)] in view of Propylene Glycol (https://web.archive.org/web/20040324043604/https://www.inchem.org/documents/pims/chemical/pim443.htm; Published: 03/24/2001) .
*Please note that in the process of searching for the elected embodiment, the examiner found art which reads on the broader recitation of the claims (i.e. propylene glycol a species in the genus to which the elected species of triethyl citrate belongs) and in an effort to expedite prosecution, this art has been applied.
With regard to claim 21, the Examiner notes that page 12 of the specification discloses “[b]y Type IV-like, it is meant that the formulation comprises no oil, for example no triglycerides or mixed glycerides. When a Type IV-like formulation is used, it may comprise more than the 50 wt% of solvent” (pg. 12).
Claim Analysis: With regard to the claim 16 recitation of “the at least one cannabinoid is synthetic or highly purified from its natural source” is a product by process limitation which does not compositionally further limit the formulation. A cannabinoid is a cannabinoid whether it is synthetic, highly purified, or not.
With regard to claims 1, 14, 24, 37 & 47, Goskonda teaches a solution comprising a cannabinoid, preferably, dronabinol, and the following ingredients: (i) from about 0 to about 40% water, (ii) from about 15 to about 65% alcohol, preferably ethanol, and (iii) a co-solvent that is (a) propylene glycol from about 0% to about 50%, (b) polyethylene glycol from about 0 to about 50%, and/or ( c) a combination of (a) and (b), the solution having a combined total of 100% ([0004] & [0006]). With regard to claims 1, 17, 43 & 46, Goskonda teaches the dosage forms comprise “preferably from about 0.1% to about 50% cannabinoid” [0024]. With regard to claims 1-6, 12, 13, 40 & 44, Goskonda teaches inclusion of poloxamer 124 (a=12; b=20), poloxamer 188 (a=80; b=27), triethylcitrate or mixtures thereof as solubilizing agents in an amount of from about 5% to about 85% by weight [0055]. With regard to claims 1-6, 12, 13, 40-44 & 46, it would have been prima facie obvious to the ordinary skilled artisan before the effective filing date to have looked to Goskonda’s teachings and selected a mixture comprising 28.3% poloxamer 124, 28.3% poloxamer 188, and 28.3% triethylcitrate as place to start routine optimization (28.3 *3 = ~ 85%; combined amount of poloxamer 124 and 188 = 56.6%; Math: 28.3 % + 28.3% = 56.6%). With regard to claims 15 & 44, Goskonda teaches “one skilled in the art will appreciate that the present invention is applicable to the class of pharmaceutically acceptable cannabinoids. For purposes of the present invention, the term "cannabinoid” and includes cannabigerol or cannabidiol [0042]. With regard to claims 15 & 44, it would have been prima facie obvious to the ordinary skilled artisan before the effective filing date to have looked to Goskonda’s teachings and selected any one of cannabigerol or cannabidiol as the cannabinoid for use in the solution because Goskonda teaches it as suitable for their invention. With regard to claim 16, Goskonda teaches the cannabinoids of their invention may be synthetic and natural cannabinoids that have been purified ([0042] & [0043]). With regard to claims 18-20, Goskonda teaches inclusion of an anti-oxidant in an amount of from about 0.001 % to about 20% w/w and that the anti-oxidant may be any one for butylated hydroxyanisole (BHA), butylated hydroxytoluene, Vitamin E tocopherol, ascorbyl palmitate, ascorbic acid, sodium ascorbate, propyl gallate, and sodium metabisulphite to stabilize the formulations ([0058] & [0060]). With regard to claims 18-20, it would have been prima facie obvious to have looked to Goskonda’s teachings and added about 0.001 % to about 20% w/w of any one of butylated hydroxyanisole (BHA), butylated hydroxytoluene, Vitamin E tocopherol, ascorbyl palmitate, ascorbic acid, sodium ascorbate, propyl gallate or sodium metabisulphite to the formulation. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to stabilize the formulation. With regard to claim 22, Goskonda does not teach oil as an essential reagent and in the Table 10 water-free formulations teaches these formulations are free of oil (pg. 13). With regard to claims 24 & 36, Goskonda teaches the formulation may be a gel dosage form and teaches inclusion of gelling agents ([0072], [0073] & [0084]). With regard to claim 37, cyclodextrins are taught amongst a list of absorption enhancers, absorption enhancers are not a required reagent, and Goskonda’s exemplary formulations do not include cyclodextrins, as such a person of ordinary skill would not include cyclodextrins in the formulation after looking to Goskonda’s preferred embodiments and examples ([0006]; [0070]; Examples). With regard to claim 47, Goskonda in the Table 10 formulation teaches water-free solutions comprising 37.39-49.39 propylene glycol (pg. 13). With regard to claim 1, the formulation is reasonably homogenous because Goskonda teaches the formulation is a solution and comprises solvents such as propylene glycol and solubilizing agents such as poloxamers and triethyl-citrate to dissolve the cannabinoid ([0051], [0055] & [0084]). With regard to claim 1, Goskonda teaches the solvents, dehydrated alcohol, propylene glycol, polyethylene glycol, and combinations thereof as suitable for the “desired formulation” [0051].
Goskonda does not teach motivation towards an alcohol-free formulation.
Propylene Glycol teaches “there is no evidence that propylene glycol has been a substance of abuse. Its actions are similar to those of ethanol (thrice weaker) although it is only one-0third [sic] as potent; propylene glycol could be used as an ethanol substitute if it becomes more readily available or cheaper” (pg. 010). “Considerable toxicity is unlikely after an acute exposure, with the exception of rare but dramatic arrhythmias…after rapid i.v. injection” (pg. 008). Propylene Glycol further teaches “several oral drug formulations contain propylene glycol as a solvent” (pg. 010).
The Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 127 S. Ct. 1727, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper “functional approach” to the determination of obviousness as laid down in Graham. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit.
Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel.
Here at least rationale (B) may be employed in which it would have been prima facie obvious to the ordinary skilled artisan before the effective filing date to have modified Goskonda’s formulation by substituting the dehydrated alcohol with propylene glycol as the solvent as suggested by the combined teachings of Goskonda and Propylene Glycol because Goskonda and Propylene Glycol are directed to oral pharmaceutical formulations and it is obvious to modify similar compositions in the same way. The ordinary skilled artisan would have been motivated to select propylene glycol as the solvent, over dehydrated alcohol, because Goskonda teaches propylene glycol to be a suitable solvent for practicing the invention but propylene glycol does not carry the risk of abuse and intoxication of ethanol and is suitable substitute for ethanol and may be used in oral formulation as taught by Propylene Glycol.
With regard to the recited amounts of the at least one cannabinoid/cannabidiol/dronabinol, at least one poloxamer/poloxamer 124 + poloxamer 188, solvent/polypropylene glycol + triethyl citrate, antioxidant, and the ranges of poloxamer subunits, the combined teachings of Goskonda and Propylene Glycol teach these parameters with values which fall within or overlap with the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, it would have been obvious to one of ordinary skill in the art to have modified the amount of at least one cannabinoid/cannabidiol/ dronabinol, at least one poloxamer/poloxamer 124 + poloxamer 188, solvent/polypropylene glycol + triethyl citrate, antioxidant, and the ranges of poloxamer subunits through routine experimentation to arrive at the claimed combination in order to optimize the resulting product with the ordinary skilled artisan recognizing that the at least one cannabinoid/dronabinol to control nausea and stimulate appetite as taught by Goskonda [0003], the at least one poloxamer/poloxamer 124 + poloxamer 188 are solubilizing agents, the solvent/propylene glycol is a solvent and the recited solvent of triethyl citrate is a solubilizing agent, antioxidant stabilizes the formulation, and the composition is being taught as substantially free of oil. It is obvious to optimize within prior art conditions or through routine experimentation. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
With regard to claim 21, the formulation is necessarily a Type IV-like formulation because the composition suggested by the combined teachings of Goskonda and Propylene Glycol does not comprise oil, triglycerides or mixed glycerides and comprises 28.3% triethylcitrate (i.e. solvent) and 0 to about 50% propylene glycol yielding solvent in a combined amount of 28.3 to about 78.3% (Math: 28.3 + 0 = 28.3; 28.3% + 50 = 78.3%; [0054]). The instant specification discloses “[b]y Type IV-like, it is meant that the formulation comprises no oil, for example no triglycerides or mixed glycerides. When a Type IV-like formulation is used, it may comprise more than the 50 wt% of solvent”.
With regard to claim 1, the composition is necessarily a fluid at 37°C and 1 atm because it comprises 0.0 % w/w to 50% of propylene glycol and poloxamer 124 and propylene glycol has a melting point of -60°C (i.e. it is a liquid). With regard to claim 1, this assertion is further supported by Goskonda’s teaching that a the formulation is a solution by stating “the dosage form can be converted from a solution to a suspension...” [0084]. As evidenced by Poloxamer, Poloxamer in Table I teaches the subunits and physical forms of the poloxamers
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150
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(pg. 447). Poloxamer 124 is a liquid (pg. 447). Poloxamer 124 is freely soluble in propylene glycol (Table IV-pg. 448).
With regard to claims 23 & 36 in which the formulation is a solid, the composition suggested by the combined teachings of Goskonda and Propylene Glycol comprises poloxamer 188. As evidenced by Poloxamer in Table I, poloxamer 188 is a solid. Further, Goskonda teaches the compositions of their invention may be a gel and gels are known solids. As evidenced by Bergeron, poloxamer 124 and poloxamer 188 are thermoreversible gelling agents [0097]. Further, pg. 11 of the instant specification states “for the purposes of the invention, a gel is considered to be a solid”.
Response to Arguments
In the traverse of the rejection of claims 1-6, 13, 16-24, 36-38, 40-43 and 46 under 35 U.S.C. 103 over Möschwitzer and Poloxamer, as evidenced by Bergeron, Applicant argues Möschwitzer’s invention is a solid and remains solid at elevated temperatures while the instant invention is a fluid at 37 °C and at atm (reply, pg. 9). Applicant further argues Möschwitzer’s invention is only a homogenous solution in an intermediate step and that there is no reason to modify to a fluid (reply, pg. 11-12). Applicant argues Möschwitzer and Bergeron do not teach formulations that are fluid at 37 °C and solid at 20 °C (reply, pg. 12-13). Applicant further picking and choosing in Möschwitzer has been used to recreate the invention and that procedural differences are critical when analyzing patentability (reply, pg. 14-16).
Applicant’s arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-6, 12-24, 36, 37, 40-44, 46 & 47 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,806,319 (hereinafter ‘319) in view of Moschwitzer (WO 2008/046905; previously cited). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application and the ‘319 are drawn to oral pharmaceutical formulations comprising at least one cannabinoid which may be cannabidiol or cannabidivarin; poloxamer 124 (a =12, b =20) and poloxamer 188 (a=80 and b = 27); a solvent which may be triethyl citrate, diacetin, propylene glycol, triacetin, monoacetin, propylene glycol diacetate or a mixture thereof; and an antioxidant which may be Vitamin E/alpha-tocopherol, ascorbic acid, citric acid or a mixture thereof. The formulations do not require water or alcohol and are recited as being substantially oil free. The formulations may be a solid at 20 °C, oral solution or a liquid gel capsule. The amounts of at cannabidiol or cannabidivarin, poloxamer 124 and poloxamer 188, and solvent are recited with values that overlap or fall within the claimed range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). The ordinary skilled artisan at the time of filing knew that antioxidants were added to products to preserve them. Further, it would have been obvious to one of ordinary skill in the art to have modified the amount of least one cannabinoid/cannabidiol and cannabidivarin; poloxamer 188 and poloxamer 124; solvent/triethyl citrate, and an antioxidant/Vitamin E/alpha-tocopherol/ascorbic acid through routine experimentation to arrive at the claimed combination in order to optimize the resulting product.
The ‘319 does not recite a Type IV formulation.
Moschwitzer teaches that dissolution velocity is a key determinant for bioavailability of orally administered drugs [0001]. Moschwitzer teaches “The pharmaceutical composition is only related to solubilizing mixtures of type IV of the lipid formulation classification system 15 (LFCS), defined by Pouton (see paragraph [0012]) as oil-free formulations based on surfactants and co-solvents and therefore oils are specifically excluded as co-solvents in the present invention” (i.e. the formulation comprises less than 1 wt % of oil based on the total composition’ [0035]). Also excluded are Type I, II, IIIA, and IIIB formulations [0035]. Moschwitzer teaches and claims the poorly soluble active substance is selected from the group consisting of cannabinoid agonists, cannabinoid inverse agonists and cannabinoid antagonists (i.e. cannabinoids, claim 14, [0026] & ][0027]).
It would have been prima facie obvious to modify the composition recited by the ‘319 claims to produce a Type IV composition as suggested by Moschwitzer because the ‘319 and Moschwitzer are drawn to oral delivery compositions which improve the dissolution of poorly soluble active agents which may be cannabinoid receptor agonists and antagonists (i.e. cannabinoids). The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to improve the dissolution and bioavailability of the cannabinoids
The instant claims are therefore an obvious variant of the claims of the ‘319 patent.
Claims 1-6, 12-24, 36, 37, 40-44, 46 & 47 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 41-66 of copending Application No. 18/477,467 (hereinafter ‘467) in view of Moschwitzer (WO 2008/046905; previously cited). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application and the ‘467 are drawn to oral pharmaceutical formulations comprising at least one cannabinoid including tetrahydrocannabinol (THC), cannabidiol or cannabidivarin; poloxamer 124 (a =12, b =20) and poloxamer 188 (a=80 and b = 27); a solvent which may be triethyl citrate, diacetin, propylene glycol, triacetin, monoacetin, propylene glycol diacetate or a mixture thereof; and an antioxidant which may be Vitamin E/alpha-tocopherol, ascorbic acid, citric acid or a mixture thereof in overlapping amounts. The formulations do not require water and comprises less than 2 wt% water (including 0%), do not require alcohol, and do not require oil (i.e. substantially oil free). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). The ordinary skilled artisan at the time of filing knew that antioxidants were added to products to preserve them. Further, it would have been obvious to one of ordinary skill in the art to have modified the amount of least one cannabinoid/cannabidiol and cannabidivarin; poloxamer 188 and poloxamer 124; solvent/triethyl citrate, and an antioxidant/Vitamin E/alpha-tocopherol/ascorbic acid through routine experimentation to arrive at the claimed combination in order to optimize the resulting product. The formulations may be a solid at 20 °C in that they are taught to be in tablet and powder forms; the formulation is also taught as liquids including solution or a liquid gel capsule.
The ‘319 does not recite a Type IV formulation.
Moschwitzer teaches that dissolution velocity is a key determinant for bioavailability of orally administered drugs [0001]. Moschwitzer teaches “The pharmaceutical composition is only related to solubilizing mixtures of type IV of the lipid formulation classification system 15 (LFCS), defined by Pouton (see paragraph [0012]) as oil-free formulations based on surfactants and co-solvents and therefore oils are specifically excluded as co-solvents in the present invention” (i.e. the formulation comprises less than 1 wt % of oil based on the total composition’ [0035]). Also excluded are Type I, II, IIIA, and IIIB formulations [0035]. Moschwitzer teaches and claims the poorly soluble active substance is selected from the group consisting of cannabinoid agonists, cannabinoid inverse agonists and cannabinoid antagonists (i.e. cannabinoids, claim 14, [0026] & ][0027]).
It would have been prima facie obvious to modify the composition recited by the ‘467 claims to produce a Type IV composition as suggested by Moschwitzer because the ‘467 and Moschwitzer are drawn to oral delivery compositions which improve the dissolution of poorly soluble active agents which may be cannabinoid receptor agonists and antagonists (i.e. cannabinoids). The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to improve the dissolution and bioavailability of the cannabinoids
The instant claims are therefore an obvious variant of the claims of the ‘319 patent.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant requests the double patenting rejection be held in abeyance (reply, pg. 16).
Applicants' request is acknowledged, however, a request to hold a rejection in abeyance is not a proper response to a rejection. Rather, a request to hold a matter in abeyance may only be made in response to an OBJECTION or REQUIREMENTS AS TO FORM (see MPEP 37 CFR 1.111(b) and 714.02). Thus, the double patenting rejection is maintained as no action regarding these rejections has been taken by applicants at this time.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LORI K MATTISON whose telephone number is (571)270-5866. The examiner can normally be reached 9-7 (M-F).
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/LORI K MATTISON/ Examiner, Art Unit 1619
/NICOLE P BABSON/ Primary Examiner, Art Unit 1619
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