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 .
Status of the Claims
This Office Action is in response to Applicant's Restriction Requirement remarks filed on December 1, 2025. Claim(s) 41-68 are pending. Claim(s) 67-68 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant's election of Group I drawn to an oral pharmaceutical formulation without traverse of the restriction requirement in the reply is acknowledged. The requirement is deemed proper and is therefore made FINAL. Claim(s) 41-66 are examined herein insofar as they read on the elected invention and species.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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Claims 41-66 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 12-24 and 36-37, 40-44, 46-47 of copending Application No. 15/640,033. Although the claims at issue are not identical, they are not patentably distinct from each other. The copending claims are drawn to an oral pharmaceutical formulation comprising: at least one cannabinoid, which is present in an amount from about 10 wt. % to about 50 wt. %, based on the total formulation; at least one poloxamer, which is present in an amount from about 25 wt. % to about 75 wt. %, based on the total formulation; and a solvent, which is present in an amount from about 20 wt. % to about 50 %, based on the total formulation; wherein the solvent is diacetin, propylene glycol, triacetin, monoacetin, propylene glycol diacetate, triethyl citrate or mixtures thereof, wherein the solvent comprises the at least one cannabinoid and the at least one poloxamer, and wherein the formulation is substantially oil-free. The instant claims are drawn to an oral pharmaceutical formulation comprising: at least one cannabinoid; at least one poloxamer of formula II; and a solvent, wherein the solvent comprises diacetin, propylene glycol, triacetin, monoacetin, propylene glycol diacetate, triethyl citrate, or a mixture thereof. The claims of both applications overlap highly in scope.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 41-66 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 9-22, 25-26, and 35-37 of copending Application No. 16/959,357. Although the claims at issue are not identical, they are not patentably distinct from each other. The copending claims are drawn to an oral pharmaceutical formulation, comprising: a first cannabinoid, comprising tetrahydrocannabinol (THC), and an analogue thereof, or a mixture thereof, a second cannabinoid, comprising cannabidiol (CBD), and an analogue thereof, or a mixture thereof; at least one poloxamer; and a solvent of formula (1). The instant claims are drawn to an oral pharmaceutical formulation comprising: at least one cannabinoid; at least one poloxamer of formula II; and a solvent, wherein the solvent comprises diacetin, propylene glycol, triacetin, monoacetin, propylene glycol diacetate, triethyl citrate, or a mixture thereof. The claims of both applications overlap highly in scope.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 41-66 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-11, 13-23, 26, and 28-30 of copending Application No. 16/959,354. Although the claims at issue are not identical, they are not patentably distinct from each other. The copending claims are drawn to an oral pharmaceutical composition comprising: a pharmaceutical formulation; and at least one modified-release agent; wherein the pharmaceutical formulation comprises: at least one cannabinoid; at least one poloxamer; and a solvent, wherein the solvent is diacetin, propylene glycol, triacetin, monoacetin, propylene glycol diacetate, triethyl citrate, or mixtures thereof, and wherein the pharmaceutical formulation is substantially oil-free, and wherein the oral pharmaceutical composition comprises a tablet, powder, liquid gel capsule, solid capsule, granule, or extrudate. The instant claims are drawn to an oral pharmaceutical formulation comprising: at least one cannabinoid; at least one poloxamer of formula II; and a solvent, wherein the solvent comprises diacetin, propylene glycol, triacetin, monoacetin, propylene glycol diacetate, triethyl citrate, or a mixture thereof. The copending claims are embraced by the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 41-66 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 and 15 of US Patent 11,806,319. Although the claims at issue are not identical, they are not patentably distinct from each other. The patented claims are drawn to an oral pharmaceutical formulation comprising: at least one cannabinoid, which is present in an amount from about 10 wt. % to about 50 wt. %, based on the total formulation; at least one poloxamer, which is present in an amount from about 25 wt. % to about 75 wt. %, based on the total formulation; and a solvent, which is present in an amount from about 20 wt. % to about 50 %, based on the total formulation; wherein the solvent is diacetin, propylene glycol, triacetin, monoacetin, propylene glycol diacetate, triethyl citrate or mixtures thereof, wherein the solvent comprises the at least one cannabinoid and the at least one poloxamer, and wherein the formulation is substantially oil-free. The instant claims are drawn to an oral pharmaceutical formulation comprising: at least one cannabinoid; at least one poloxamer of formula II; and a solvent, wherein the solvent comprises diacetin, propylene glycol, triacetin, monoacetin, propylene glycol diacetate, triethyl citrate, or a mixture thereof. The instant claims are embraced by the copending claims.
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 of this title, 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.
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 41-57 and 59-66 are rejected under 35 U.S.C. 103(a) as being unpatentable over by Murty (US 2016/0184258) of record (IDS 2/28/24, reference #127).
Regarding claims 41-45, 48-57, 65, and 66, Murty teaches oral dosage forms of cannabinoids and 10 to 60% of a surfactant (Abstract; claim 1) comprising: about 1 to 60 wt.% cannabinoids THC, CBD, CBDV, for example (claims 1 and 6), which are pure or synthetic [0271], which is sufficiently specific to the instantly claimed from about 10 to 50 wt.%; at least one poloxamer 124 or 188 (claim 12); solvent according to the formula propylene glycol (claim 13).
Murty teaches various cannabinoids can be used alone or in combination to achieve synergistic effects. Suitable cannabinoid compounds which can be used either alone or in combination include tetrahydrocannabinol, Δ9-tetrahydrocannabinol (THC), Δ8-tetrahydrocannabinol, standardized marijuana extracts, Δ8-tetrahydrocannabinol-DMH, Δ9-tetrahydrocannabinol propyl analogue (THCV), 11-hydroxy-tetrahydrocannabinol, 11-nor-9-carboxy-tetrahydrocannabinol, 5′-azido-Δ8-tetrahydrocannabinol, AMG-1, AMG-3, AM411, AM708, AM836, AM855, AM919, AM926, AM938, cannabidiol (CBD), cannabidiol propyl analogue (CBDV), cannabinol (CBN), cannabichromene (CBC), cannabichromene propyl analogue, cannabigerol (CBG), cannabicyclol (CBL), cannabielsoin (CBE), cannabinodiol (CBDL), and cannabitriol (CBTL), among others [0088].
Murty teaches surfactants wherein preferred polyoxyethylene-polyoxypropylene block copolymers, which can be used include poloxamers (108, 124, 182, 183, 188, 212, 217, 238, 288, 331, 338, 335, and 407), and mixtures thereof [0067].
Regarding claims 59, 60, and 61, Murty teaches that the oral dosage form comprises about 1-70 wt.% co-solvent and about 0.01-15 wt.% antioxidants such as ascorbyl palmitate, tocopherol and propyl gallate (claims 13 and 14). The range of about 1-70 wt.% co-solvent is sufficiently specific to the instant claimed range of about 10 to 80 wt.%.
Regarding claim 62, Murty teaches a semi-solid inducer thus making a solid composition at 20° C and 1 atm (claims 3-5) especially at the higher amounts of semi-solid inducer that can make an isotropic semi-solid or waxy solid phase [0033-0034] that is melted and allowed to cool in a capsule [0154-0159] which would then solidify.
Regarding claims 63, Murty teaches a genus of oral dosage forms (claim 1) and exemplifies capsules (Examples 6-16; Tables 15 and 16) including hard gelatin capsules [0204], thus making semi-solid matrix or liquid filled gel capsules [0214].
Murty teaches concentrations of cannabinoid, surfactant (specifically poloxamer), and solvent that overlaps partially to the instantly claimed range. MPEP 2144.05 states: 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).
Murty does not specifically teach the ratio of the first and second cannabinoid in the range of 100:1 to 1:100 or 1:1, as required by the limitations of claims 46 and 47, respectively or the amount of water, as required by claim 64.
It would have been obvious to one of ordinary skill in the art at the time the claimed invention was filed to have employed cannabinoids in the oral formulations as taught by Murty and varied the ratios of the cannabinoids or the presence/absence of water. The specific combination of features claimed is disclosed within the broad generic ranges taught by the reference but such "picking and choosing" within several variables does not necessarily give rise to anticipation. Corninq Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989). Where, as here, the reference does not provide any motivation to select this specific combination of variables, anticipation cannot be found. That being said, however, it must be remembered that "[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious". KSR v. Teleflex, 127 S, Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). "[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious", the relevant question is "whether the improvement is more than the predictable use of prior art elements according to their established functions." (Ida). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." KSR v. Teleflex, 127 S, Ct. 1727, 1741 (2007). The Court emphasized that "[a] person of ordinary skill is... a person of ordinary creativity, not an automaton." Id. at 1742. Consistent with this reasoning, it would have obvious to have selected various combinations of various disclosed ingredients from within a prior art disclosure, to arrive compositions "yielding no more than one would expect from such an arrangement".
Thus, based on the foregoing reasons, the instant claims are deemed unpatentable over the cited reference.
Claim 58 is rejected under 35 U.S.C. 103(a) as being unpatentable over by Murty (US 2016/0184258) of record (IDS 2/28/24, reference #127) as applied to claims 41-57 and 59-66 in the 103 rejection above of record in view of Rigassi (US 2008/0279940) of record (IDS 2/28/24, reference #90).
Murthy is discussed above.
Murty does not specifically teach triethyl citrate as solvent.
Rigassi teaches the equivalence of propylene glycol and triethyl citrate as hydrophilic solvent component (claim 6) as well as other hydrophilic substances [0085] for spontaneously dispersible pharmaceutical compositions (Abstract).
It would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to use propylene glycol as a solvent in the formulations as taught by Murty and also have used triethyl citrate. The motivation, provided by Rigassi, teaches the functional equivalence of propylene glycol and triethyl citrate for the same purpose. "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007). Moreover, “Where two known alternatives are interchangeable for a desired function, an express suggestion to substitute one for the other is not needed to render a substitution obvious." In re Fout, 675 F.2d 297, 301 (CCPA 1982). Thus, the ordinary artisan would have a reasonable expectation of success in employing triethyl citrate or other analogous hydrophilic compounds taught in the art in the oral dosage form of Murty.
Thus, based on the foregoing reasons, the instant claims are deemed unpatentable over the cited reference.
Conclusion
Claims 41-66 are not allowed.
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/SAHAR JAVANMARD/Primary Examiner, Art Unit 1622