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 .
Election/Restrictions
Acknowledgement is made to Applicant’s response filed 03/05/2026.
Claims 1-8, 10-14, 16, 29-30, 32, 36-37, 44, 48-49, and 63 are pending.
Claim 63 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 03/05/2026.
Claims 1-8, 10-14, 16, 29-30, 32, 36-37, 44, and 48-49 are currently under consideration to the extent that they read upon Applicant’s elected species.
NOTE: Applicant elected –
Active ingredient - Cannabinoid or a pharmaceutically acceptable salt thereof
Cannabinoid - a cannabidiol (CBD) or a pharmaceutically acceptable salt thereof
Coating material - hydroxypropyl methylcellulose acetate succinate (HPMCAS)
Capsule Coating - an enteric coating
Second active ingredient - a cannabigerol (CBG)
Ingredient form - powder
Particle diameter - about 50 micrometers to about 150micrometers
Active ingredient amount - 2 mg to about 50mg
Disease or condition - an inflammation
First capsule size - Size 3
Second capsule size -Size 00.
Upon further search and examination the species election over coating material is broadened to include maltodextrin and hydroxypropyl methylcellulose. The first capsule size is broadened to include 1, 2, 4, or 5. As well as the second capsule is size is broadened to include 000, 0, or 1.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/13/2023, 12/13/2023, 02/13/2024, 07/25/2024, 01/06/2025, 02/18/2025, and 11/24/2025 are being considered by the examiner. The submission is in compliance with the provisions of 37 CFR 1.97.
Claim Rejections - 35 USC § 112
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 1 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.
Claim 1 is indefinite for reciting “wherein within the plurality of spray dried particles the plurality of spray dried particles ….”. It is not clear what the difference is between -within the plurality of spray dried particles- and -the plurality of spray dried particles-. Thus, it is not clear why this statement is recited twice.
Claims 2-8, 10-14, 16, 29-30, 32, 36-37, 44, and 48-49 are rejected as depending from claim 1 without resolving the issue.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-7, 10-14, 16, 36, and 44 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Wilkhu (US11160757B1).
Wilkhu discloses a microparticulate comprising one or more cannabinoids and a pH dependent release polymer (see entire document, for instance, Abstract).
Wilkhu teaches a composition that can be in a form of powder comprising coated microparticles of one or more cannabinoid, and wherein the composition comprises excipients (see entire document, for instance, column 6, lines 50-53 and claims 9-11). Wilkhu discloses a method of preparing the said microparticulate cannabinoid containing formulation comprising spray drying the formulation (see entire document, for instance, column 3, lines 64-67 and Example 3). Wilkhu teaches that the pH dependent release polymer is selected from the group consisting of: hydroxypropyl methyl cellulose acetate succinate (HPMCAS), hydroxypropyl methyl cellulose phthalate (HPMCP) (see entire document, for instance, column 2, lines 53-67 and claim 4). Wilkhu discloses the pharmaceutical formulation of the present invention may be prepared by any well-known methods in the art, such as encapsulating (column 26, lines 10-15).
Wilkhu teaches that the said formulation comprises a microparticulate comprising one or more cannabinoids, and one or more pharmaceutically acceptable excipients see entire document, for instance, column 7 lines 20-22). The cannabinoid is selected from the group consisting of: cannabichromene (CBC), cannabidiol (CBD), cannabidivarin (CBDV), cannabigerol (CBG), tetrahydrocannabinol (THC), (see entire document, for instance, column 7, lines 18-40). In a preferred embodiment, the formulation comprises at least two cannabinoids, selected from the group consisting of, cannabidiol (CBD), tetrahydrocannabinol (THC), cannabigerol (CBG) (see entire document, for instance, column 7, lines 53-57).
Wilkhu discloses oil-based formulations with two different actives; CBD alone or a combination of THC and CBD (column 39, lines 50-55). WILKHU teaches cannabinoid containing formulations which were gastric resistant and able to deliver cannabinoids to the enteric or colonic areas (see entire document, for instance, column 2, lines 7-10). WILKHU discloses the microparticulates include a component which enables targeted delivery to the colon or intestines (see entire document, for instance, column 2, lines 17-21).
WILKHU teaches that the said excipients include carriers, diluents and fillers such as sugar, polyethylene glycol, alginic acid or a salt thereof such as sodium alginate, cellulose, dextrin, etc. (see entire document, for instance, column 24, line 16 to column 25, line 12). The said lactose may be lactose monohydrate or lactose anhydrous (see entire document, for instance, column 24, line 16 to column 25, line 12). WILKHU discloses hydroxypropyl methylcellulose (column 26, line 29). WILKHU teaches the unit dose comprises ranging from about 5 mg and about 5000 mg of cannabinoid, for example, about 5 mg, about 10 mg, about 20 mg, about 30 mg, about 40 mg, about 50 mg (column 10, lines 53-56).
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.
Claim(s) 1-7, 10-14, 16, 36, 44, and 48-49 are rejected under 35 U.S.C. 103 as being unpatentable over Wilkhu (US11160757B1).
Wilkhu discloses a microparticulate comprising one or more cannabinoids and a pH dependent release polymer (see entire document, for instance, Abstract).
Wilkhu teaches a composition that can be in a form of powder comprising coated microparticles of one or more cannabinoid, and wherein the composition comprises excipients (see entire document, for instance, column 6, lines 50-53 and claims 9-11). Wilkhu discloses a method of preparing the said microparticulate cannabinoid containing formulation comprising spray drying the formulation (see entire document, for instance, column 3, lines 64-67 and Example 3). Wilkhu teaches that the pH dependent release polymer is selected from the group consisting of: hydroxypropyl methyl cellulose acetate succinate (HPMCAS), hydroxypropyl methyl cellulose phthalate (HPMCP) (see entire document, for instance, column 2, lines 53-67 and claim 4). Wilkhu discloses the pharmaceutical formulation of the present invention may be prepared by any well-known methods in the art, such as encapsulating (column 26, lines 10-15).
Wilkhu teaches that the said formulation comprises a microparticulate comprising one or more cannabinoids, and one or more pharmaceutically acceptable excipients see entire document, for instance, column 7 lines 20-22). The cannabinoid is selected from the group consisting of: cannabichromene (CBC), cannabidiol (CBD), cannabidivarin (CBDV), cannabigerol (CBG), tetrahydrocannabinol (THC), (see entire document, for instance, column 7, lines 18-40). In a preferred embodiment, the formulation comprises at least two cannabinoids, selected from the group consisting of, cannabidiol (CBD), tetrahydrocannabinol (THC), cannabigerol (CBG) (see entire document, for instance, column 7, lines 53-57).
Wilkhu discloses oil-based formulations with two different actives; CBD alone or a combination of THC and CBD (column 39, lines 50-55). WILKHU teaches cannabinoid containing formulations which were gastric resistant and able to deliver cannabinoids to the enteric or colonic areas (see entire document, for instance, column 2, lines 7-10). WILKHU discloses the microparticulates include a component which enables targeted delivery to the colon or intestines (see entire document, for instance, column 2, lines 17-21).
WILKHU teaches that the said excipients include carriers, diluents and fillers such as sugar, polyethylene glycol, alginic acid or a salt thereof such as sodium alginate, cellulose, dextrin, etc. (see entire document, for instance, column 24, line 16 to column 25, line 12). WILKHU discloses hydroxypropyl methylcellulose (column 26, line 29). WILKHU teaches the unit dose comprises ranging from about 5 mg and about 5000 mg of cannabinoid, for example, about 5 mg, about 10 mg, about 20 mg, about 30 mg, about 40 mg, about 50 mg (column 10, lines 53-56).
Thus, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the composition as described by WILKHU. It would be within the purview of the skilled artisan to manipulate amounts of active ingredients within said ranges by routine experimentation, with a reasonable expectation of success. It is noted that MPEP 2144.05 states: "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).” In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05). In this case, it would be within the purview of the ordinarily skilled artisan to select amounts of each active ingredients from within the disclosed ranges, including amounts instantly claimed, by routine experimentation, with a reasonable expectation of success.
It is noted that WILKHU et al teaches the instantly claimed components, wherein it is further noted that anticipation is the greatest form of obviousness. Additionally, it would be obvious at the time the invention was filed to rearrange the components of WILKHU and obtain additional embodiments of the invention as claimed. A reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. Where, as here, the specific combination of features claimed is disclosed within the broad teachings of the reference but the reference does not disclose the specific combination of variables (for example, capsule size), in a specific embodiment or in a working example, “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989).
However, "when 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." (Id.). 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.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention was made to rearrange the disclosed elements and embodiments of WILKHU et al., to include an example capsule size, to prepare the claimed composition. Such a rearrangement by a person of ordinary skill in the art who is not an automaton to yield the instantly claimed compositions and methods is within the purview of the ordinary skilled artisan upon reading WILKHU et al., as cited above, and would yield predictable results.
Claim(s) 1-8, 10-14, 16, 36 -37, 44, and 48-49 are rejected under 35 U.S.C. 103 as being unpatentable over Wilkhu (US11160757B1) as applied to claims 1-7, 10-14, 16, 36, 44, and 48-49 above, and further in view of Appel et al (US 20090142404 A1; as submitted on IDS of 6/13/2023).
The teachings of Wilkhu et al have been set forth above. However, they do not expressly disclose specifics such as the particle diameter of the active agent. Appel remedy this deficiency.
Appel discloses a drug in a solubility-improved form and in the form of particles at least partially coated with the precipitation-inhibiting polymer (see entire document, for instance abstract). Appel teaches using a spray drying process to form particles of a drugs coated with HPMCAS ([0132]). Appel discloses the particles are in the size from 0.1 to 500 µm ([0015]). Appel teaches the drug and polymer are mixed with excipients ([0010]). Appel discloses the drug and polymer can be formulated into capsules ([0085]). Appel teaches sodium alginate and crospovidone, while binders include guar gum ([0091-0092]).
Thus, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the composition as described by teachings of Appel et al with that of Wilkhu et al. It would be within the purview of the skilled artisan to manipulate amounts of active ingredients within said ranges by routine experimentation, with a reasonable expectation of success. It is noted that MPEP 2144.05 states: "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).” In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05). In this case, it would be within the purview of the ordinarily skilled artisan to select amounts of each active ingredients from within the disclosed ranges, including amounts instantly claimed, by routine experimentation, with a reasonable expectation of success.
It would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to have combined the teachings of Appel et al with that of Wilkhu et al to arrive at the instant invention. Wilkhu discloses a powdery composition comprising one or more cannabinoids. Wilkhu teaches that the formulation comprises coated microparticles comprising the cannabinoid for optimum delivery and that the coating material provides for a pH dependent release of the active agent. Wilkhu et al however is silent with regard to the particle sizes. Thus, one of ordinary skill in the art is motivated to look for these specifics to ensure an effective delivery of the formulations. Appel teaches a drug in a solubility-improved form and in the form of particles at least partially coated with the precipitation-inhibiting polymer (see entire document, for instance abstract). Appel provides guidance for particle size range for the active agent.
Claim(s) 1-7, 10-14, 16, 36 -37, 44, and 48-49 are rejected under 35 U.S.C. 103 as being unpatentable over Wilkhu (US11160757B1) as applied to claims 1-7, 10-14, 16, 36, 44, and 48-49 above, and further in view of HELLER (US 20200054702 A1; as submitted on IDS of 6/13/2023).
The teachings of Wilkhu et al have been set forth above. However, they do not expressly disclose specifics such as the excipient. HELLER remedy this deficiency.
HELLER discloses a cannabinoid formulation that comprises encapsulated cannabinoids entrapped in a polymer matrix (see entire document, for instance, [0010]). HELLER teaches cannabinoids such as: delta-9-tetrahydrocannabinolic acid (THCa), delta-9-tetrahydrocannabinol (THC), cannabidiol acid (CBDa), cannabidiol (CBD), cannabinol (CBN), cannabigerol (CBG), cannabichromene (CBC), tetrahydrocannabivarin (THCV), cannabidivarin (CBDV) (see entire document, for instance, [0012]).HELLER discloses component, interchangeably referred to herein as the active ingredient, can include oils ([0012] ).HELLER teaches cannabis oil can also be encapsulated with a polymer coating and embedded into a matrix upon which they can be converted into a powder as described herein ([0067] ). HELLER discloses maltodextrin (a coating material per instant specification) is an illustrative example of a suitable polymer matrix ([0241]). HELLER teaches the encapsulated cannabinoid emulsion can be combined with an aqueous solution of maltodextrin ([0241]). The emulsion and the aqueous maltodextrin are completely, or at least substantially miscible ([0241]). In this way the encapsulated cannabinoids can be homogeneously distributed or dispersed throughout the solution ([0241]). HELLER discloses encapsulated cannabinoids into maltodextrin can be performed in a manner that prevents aggregation of particles and maintains adequate particle sizes of the encapsulated cannabinoids ([0241]). Encapsulated cannabinoid particle sizes can be established and maintained between 50 nm and 20 microns ([0241]). HELLER teaches edible dosage forms can be made with the encapsulated cannabinoid powder ([0387]). HELLER teaches the honey is mixed in easily and does not phase separate ([0390]).
It would have been obvious to utilize honey as taught in HELLER in the composition of Wilkhu. One would have been motivated to do so HELLER teaches that teaches honey is mixed in easily and does not phase separate (a substantially homogenous mixture). There would be a reasonable expectation of success since Wilkhu and HELLER are both drawn to compositions for cannabinoids.
Claim(s) 1-8, 10-14, 16, 36 -37, 44, and 48-49 are rejected under 35 U.S.C. 103 as being unpatentable over Wilkhu (US11160757B1) as applied to claims 1-7, 10-14, 16, 36, 44, and 48-49 above, and further in view of Temtsin-Krayz (WO 2019038756 or US 20200368156; as submitted on IDS of 6/13/2023).
The teachings of Wilkhu et al have been set forth above. However, they do not expressly disclose specifics such as the particle diameter of the active agent. Temtsin-Krayz remedy this deficiency.
Temtsin-Krayz discloses a pharmaceutical composition comprising solid particles of at least one active agent and solid particles of a diluent, said pharmaceutical composition being substantially free of excipients other than the solid diluent, wherein said pharmaceutical composition having at least 90% of the particles of said at least one active agent with a mean particle size of 10 micron to 30 microns and the particles of said diluent have a mean particle size of 30-200 microns (see entire document, for instance, abstract). The said formulation prepared by spray drying method to prepare (see entire document, for instance, abstract). Temtsin-Krayz teaches the pharmaceutical composition may be administered in oral solid dosage form ([0036]). Temtsin-Krayz discloses the active agent may be cannabis active compound (see entire document, for instance, [0018], [0093], [0109] and claim 4). Temtsin-Krayz teaches the particles are spray dried and that the powders may be powder microspheres, coated powder microspheres, liposomal dispersions and combinations thereof (see entire document, for instance, [0034] and [0100]).
Thus, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the composition as described by teachings of Temtsin-Krayz et al with that of Wilkhu et al. It would be within the purview of the skilled artisan to manipulate amounts of active ingredients within said ranges by routine experimentation, with a reasonable expectation of success. It is noted that MPEP 2144.05 states: "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).” In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05). In this case, it would be within the purview of the ordinarily skilled artisan to select amounts of each active ingredients from within the disclosed ranges, including amounts instantly claimed, by routine experimentation, with a reasonable expectation of success.
It would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to have combined the teachings of Temtsin-Krayz et al with that of Wilkhu et al to arrive at the instant invention. Wilkhu discloses a powdery composition comprising one or more cannabinoids. Wilkhu teaches that the formulation comprises coated microparticles comprising the cannabinoid for optimum delivery and that the coating material provides for a pH dependent release of the active agent. Wilkhu et al however is silent with regard to the particle sizes. Thus, one of ordinary skill in the art is motivated to look for these specifics to ensure an effective delivery of the formulations.
Temtsin-Krayz teaches a dry powder formulation comprising cannabis compounds and one or more suitable excipients and teaches that the said particles may be in the form of coated microparticles. Temtsin-Krayz provides guidance for particle size range for the active agent and excipients and that the inhaler may comprise such formulations in a capsule. Temtsin-Krayz provides guidance for particle size range for the active agent. There would be a reasonable expectation of success since Wilkhu and Temtsin-Krayz are both drawn to compositions for cannabis.
Claim(s) 1-7, 10-14, 16, 29-30, 32, 36 -37, 44, and 48-49 are rejected under 35 U.S.C. 103 as being unpatentable over Wilkhu (US11160757B1) as applied to claims 1-7, 10-14, 16, 36, 44, and 48-49 above, and further in view of He et al (US 20080014257 A1) and DeHaan et al (US 20150136130 A1; as submitted on IDS of 6/13/2023).
The teachings of Wilkhu et al have been set forth above. However, they do not expressly disclose specifics such as the capsule size and hydroxypropylmethyl cellulose. He remedy this deficiency.
He discloses oral dosage form of a pharmaceutically active ingredient comprising: (a) an outer capsule and (b) non-uniform pellets, having a non-uniform shape and/or size, contained within the capsule (see entire document, for instance, abstract). He teaches pharmaceutical compositions for oral administration, including controlled release compositions ([0001]). He teaches capsules made of hydroxypropylmethyl cellulose (HPMC) ([0094]). He discloses the capsules can comprise admixture with one or more other optional ingredients, as discussed herein ([0095]). Exemplary optional ingredients include, but are not limited to, binding agents, filling agents, lubricating agents, suspending agents, sweeteners, flavoring agents, preservatives, buffers, wetting agents, disintegrants, effervescent agents, stabilizers, or other optional ingredients or excipients, examples of which are given below ([0095]). Such excipients are known in the art ([0095]). He teaches a pH dependent polymer and/or a pH independent polymer ([0154]). Specific examples of pH-dependent polymers include hydroxypropyl methylcellulose acetate succinate ([0154]). He discloses a given capsule will contain pellets that exhibit variation in shape and/or size, such that not all of the pellets in a given capsule have the same shape and size ([0097]). He teaches the size can be assessed based on a single dimension, such as diameter, cross-section, weight or volume ([0098]). Those skilled in the art can select the size and shape of pellets to achieve a desired delivery profile, including a controlled and/or extended delivery profile ([0098]).
DeHaan discloses a single dose or multi-dose capsule or cartridge contained in a dry powder inhaler (see entire document, for instance, [0013] and claim 49). DeHaan teaches that preferably, the receptacle is a size 2 or a size 3 capsule (See [0018]). DeHaan discloses the capsules are solid dosage forms in which the drug is enclosed within either a hard or soft soluble container or “shell” ([0279]). The shells are usually formed from gelatin; however, they also may be made from starch, such as hydroxypropyl methylcellulose (HPMC), or other suitable substances ([0279]).
It would have been obvious to utilize He and DeHaan et al with that of Wilkhu et al to arrive at the instant invention. A skilled artisan would have been motivated to do so as He and DeHaan et al teaches improved controlled release or sustained release dosage forms of a pharmaceutically active ingredient, wherein Wilkhu et al also teach that the formulation comprises coated microparticles comprising the cannabinoid for optimum delivery and that the coating material provides for a pH dependent release of the active agent. There would be a reasonable expectation of success since Wilkhu and He and DeHaan et al are both drawn to compositions for optimum delivery and that the coating material provides for a pH dependent release of the active agent.
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 1-8, 10-14, 16, 29-30, 32, 36-37, 44, and 48-49 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 14-15, 18, 20-21, 23, 25, 28-29, and 31 of copending Application No. 18/031,898 in view of Appel et al (US 20090142404 A1; as submitted on IDS of 6/13/2023). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a provisional nonstatutory double patenting rejection.
The copending claims are directed to a powdery pharmaceutical composition, comprising :i) particles of a pharmaceutically acceptable excipient; and ii) a plurality of spray dried particles, each particle of the plurality of spray dried particles comprising a cannabinoid or a pharmaceutically acceptable salt thereof, substantially encapsulated in a coating material, wherein within the plurality of spray dried particles, the plurality of spray dried particles, individually have a particle diameter ranging from about 1 micrometer to about 10 micrometers, as measured by a particle analyzer using laser diffraction and, wherein the coating material comprises a hydroxypropyl methylcellulose (HPMC), a hydroxypropyl methylcellulose acetate succinate (HPMCAS), a cyclodextrin, a maltodextrin, a povidone, a copovidone or any combination thereof. The powdery pharmaceutical composition, comprising the lactose wherein the lactose comprises a milled lactose, a sieved lactose, a micronized lactose, a spray dried lactose, at least substantially anhydrous lactose, a monohydrate lactose, a pharmaceutically acceptable salt of any of these, or any combination thereof. The powdery pharmaceutical composition, wherein the cannabinoid or pharmaceutically acceptable salt thereof comprises cannabigerol (CBG), cannabichromene (CBC), cannabidivarin (CBDV), cannabidiol (CBD), a tetrahydrocannabinol (THC), cannabinol (CBN) a pharmaceutically acceptable salt of any of these, or any combination thereof.
However, the copending claims do not explicitly teach a particle diameter ranging from about 50 micrometers to about 150 micrometers.
Appel discloses a drug in a solubility-improved form and in the form of particles at least partially coated with the precipitation-inhibiting polymer (see entire document, for instance abstract). Appel teaches using a spray drying process to form particles of a drugs coated with HPMCAS ([0132]). Appel discloses the particles are in the size from 0.1 to 500 µm ([0015]). Appel teaches the drug and polymer are mixed with excipients ([0010]). Appel discloses the drug and polymer can be formulated into capsules ([0085]). Appel teaches sodium alginate and crospovidone, while binders include guar gum ([0091-0092]).
Thus, it would be obvious to an artisan of ordinary skill before the effective filing select a different particle size range for different routes of administration. Thus, the scope of the copending claims anticipates the scope of the instant claims.
Claims 1-8, 10-14, 16, 29-30, 32, 36-37, 44, and 48-49 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-9, 20-23, 26-29, 34-37of copending Application No. 18/561,351 in view of Tamtsin-Krayz (WO 2019038756 or US 20200368156). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a provisional nonstatutory double patenting rejection.
The copending claims are directed to a powdery pharmaceutical composition, comprising:i) particles of a pharmaceutically acceptable excipient; andii) a plurality of spray dried particles, each particle of the plurality of spray dried particles comprising:an epinephrine or a pharmaceutically acceptable salt thereof substantially encapsulated in a coating material, wherein: within the plurality of spray dried particles at least a portion of the spray dried particles comprising the epinephrine or the pharmaceutically acceptable salt thereof substantially encapsulated in the coating material, individually have a particle diameter of about 30 micrometers, as measured by a particle analyzer using laser diffraction and, the coating material comprises a hydroxypropyl methylcellulose (HPMC),a hydroxypropyl methylcellulose acetate succinate (HPMCAS), a povidone, a copovidone or any combination thereof. The powdery pharmaceutical composition is in the form of an intranasal pharmaceutical composition. The pharmaceutically acceptable excipient comprises a carbohydrate, an alginate, povidone, a carbomer, a flavor, a natural gum, a silicone, an alcohol, a butter, a wax, a fatty acid, a preservative, a pharmaceutically acceptable salt of any of these, or any combination thereof. The pharmaceutically acceptable excipient or pharmaceutically acceptable salt thereof comprises the carbohydrate or the pharmaceutically acceptable salt thereof, and wherein the carbohydrate or the pharmaceutically acceptable salt thereof comprises lactose, microcrystalline cellulose, cellulose, mannitol, sorbitol, starch, starch glycolate, hydroxypropyl methylcellulose, hydroxypropyl methylcellulose acetate succinate, a cyclodextrin, maltodextrin, croscarmellose sodium, corn starch, carrageenan, sorbitol, maltitol, glucose, a pharmaceutically acceptable salt of any of these, or any combination thereof. The powdery pharmaceutical composition described herein when stored in a sealed container placed in a room at 25° C. and a room atmosphere having about 50 percent relative humidity, retains at least about: 90% of the epinephrine or the pharmaceutically acceptable salt thereof, or the insulin or the derivative thereof after 6 months, as measured by HPLC. The epinephrine or the pharmaceutical acceptable salt thereof is present in an amount ranging from about 0.1 mg to about 0.5 mg.
However, the copending claims do not explicitly teach cannabinoid.
Tamtsin-Krayz teach a powdery formulation comprising an active agent and suitable excipients wherein the active agent may be epinephrine, a cannabinoid (cannabis active compounds), etc. Thus, it would be obvious to select a different active agent for the same formulations as taught by the references. The scope of the copending claims anticipates the scope of the instant claims.
Claims 1-8, 10-14, 16, 29-30, 32, 36-37, 44, and 48-49 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. 19/252,506 in view of He (US 20080014257 A1). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a provisional nonstatutory double patenting rejection.
The copending claims are directed to powdery composition, comprising: a) a plurality of encapsulated spray dried particles, wherein each particle of the plurality of spray dried particles is substantially encapsulated by a first coating, wherein the first coating is substantially encapsulated by one or more additional coatings; and b) wherein the plurality of encapsulated spray dried particles comprise a cannabinoid or a pharmaceutically acceptable salt thereof, wherein within the plurality of encapsulated spray dried particles, the plurality of encapsulated spray dried particles individually have a particle diameter ranging from about 20 micrometers to about 200 micrometers, or have a mean or median particle diameter of about 20 micrometers to about 200 micrometers, as measured by a particle analyzer using laser diffraction, i) wherein the first coating comprises a hydroxypropyl methylcellulose (HPMC), a hydroxypropyl methylcellulose acetate succinate (HPMCAS), a cyclodextrin, a maltodextrin, a povidone, a copovidone or any combination thereof; andii) wherein the one or more additional coatings comprise an enteric coating. The enteric coating comprises a methyl methacrylate (MMA), a methyl acrylate-methacrylic acid copolymer, or both. the cannabinoid or the pharmaceutical acceptable salt thereof is present in an amount ranging from about 1 mg to about 100 mg. The first coating which comprises the cyclodextrin.
However, the copending claims do not explicitly teach a methyl methacrylate (MMA), a methyl acrylate-methacrylic acid copolymer, or both.
He discloses the pH-dependent polymer is selected from the group consisting of methacrylic acid/methyl methacrylate copolymers methacrylic acid/methyl acrylate and methyl methacrylate copolymers (Eudragit FS 30D), cellulose acetate phthalate, cellulose acetate trimellitate, hydroxypropyl methylcellulose acetate succinate, hydroxypropyl methylcellulose phthalate ([0011]). Thus, it would be obvious to select a different e pH-dependent polymer for the same formulations as taught by the references. The scope of the copending claims anticipates the scope of the instant claims.
Conclusion
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/JANET JOSEPH/Patent Examiner, Art Unit 1611
/TREVOR LOVE/Primary Examiner, Art Unit 1611
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