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 Claims
The arguments filed on 08/13/2025 are acknowledged and have been fully considered. Claims 1-2, 5-12, 14-15, 17, 19, 23, and 27-29 are now pending. Claims 3-4, 13, 16, 18, 20-22, and 24-26 are canceled; claims 1, 17,and 23 are amended.
Claims 1-2, 5-12, 14-15, 17, 19, 23, and 27-29 will be examined on the merits herein.
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn.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.
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 1-2, 5-12, 14-15, 17, 19, 23, and 27-29 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. Claims 1 and 23 have been amended to recite “wherein the core is a discrete solid bead” however the introduction of a “discrete solid” bead is not supported in the disclosure. While the specification does teach an inert core such as sugar spheres and microcrystalline cellets (see instant specification as filed, paragraph 0060), this is not the same as a discrete solid bead core. As such, the limitation is new matter and fails to comply with the written description requirement.
Further claim 17 is amended to recite a “first weight” defined as the sum of the one or more cannabinoid plus the weight of the one or more drug-releasing agents plus the weight of the one or more solubilizers, however there is no mention of the “first weight” previously in the disclosure and as such it is considered new matter. It is noted that the ratio by weight of the one or more cannabinoids plus the weight of the one or more drug-releasing agents plus the weight of the one or more solubilizers is taught in the specification (see instant specification as filed, paragraph 0036), so the issue is directed towards the term of the “first weight”.
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.
Claims 1-2, 5-12, 14-15, 17, 19, 23, 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over Carley et al. (US 20120231083; as filed on PTO-892 of 10/08/2020) in view of Bosse et al. (US10179109; as filed on PTO-892 of 10/08/2020) as evidenced by NPL1 (Mydayis, 2020; screenshot of https://www.mydayis.com/adhd-treatment/how-it-works).
In regards to claims 1, 2, 6, 8, 14, and 23 Carley teaches and claims a medicament comprising a cannabinoid partitioned in an immediate release compartment and in a delayed release compartment (claim 1). The delayed release compartment maybe a solid, semisolid or liquid compartment and form a plurality of microparticles (claims 14 and 15). Carley teaches its solid compartment may be a sugar glass compartment (claim 4) and that microspheres made from starch or chitosan may be used (paragraph 0112). The cannabinoid is dronabinol (claim 17). According to Carley its compositions are especially suitable for conditions that are benefitted by therapeutic levels for more than about 5 hours, e.g. about 6 to about 8 hours or for as long as about 8 or about 12 hours (paragraph 0017). Example 12 specifically teaches a plurality of pellets composition, wherein the immediate release compartment is a plurality of solid pellets (or microspheres) and the delayed release compartment is a plurality of solid pellets comprising a delayed release modifier coating comprising dronabinol (THC) dissolved in ethanol (solubilizer), dispersed in sodium lauryl sulfate (surfactant) and charged into Neusilin US2 (i.e. a silica core) and coated with ethylcellulose (drug releasing agent) (paragraph 0272). In regards to the coating over the core, Carley teaches a delayed release dosage compartment is a dosage compartment comprising a release-modifying amount of a release modifier and a cannabinoid partitioned in said delayed release compartment and that a dosage compartment means a discrete layer, sphere, fraction or formulation encompassing a cannabinoid (paragraphs 0036-0037). Therefore it is understood the presence of cannabinoid in a delayed release modifier coating. Example 12 teaches delayed release pellets wherein Neusilin US2 is charged with the required quantity of dronabiniol to a fluid bed coater wherein the ethylcellulose coating dispersion is applied (paragraphs 0291-0296).
Going further into detail in regards to the plurality of the particles, Carley teaches that the “medicament is provided comprising a delayed release compartment and an immediate release compartment contained within the same dose unit. By example, the immediate release compartment is a plurality of solid pellets (or microspheres) and the delayed release compartment is a plurality of solid pellets comprising a delayed release modifier coating” in example 12 (paragraph 0271). As understood in the art, this is a capsule with coated, solid pellets in it. Each individual pellet would have one core. This type of structure understood in the art for delayed release medication as NPL1 shows this in a diagram (see NPL1, page 2). Specifically, “each capsule contains equal amounts of 3 different types of beads—two of which are made with different delayed-release coatings” (see NPL1, page 1). See MPEP 2131.01(II) for use of extrinsic evidence to explain the meaning of terms and phrases used in the reference relied upon as anticipatory of the claimed subject matter. In re Baxter Travenol Labs., 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991).
Regarding instant claim 5, Carley teaches a delayed release compartment comprises a release-modifying amount of a release modifier (release-controlling polymer) and that an immediate release compartment does not contain a release modifier, therefore the release of about 75% of the cannabinoid occurs within 60 minutes (paragraph 0039).
Regarding instant claim 7, Carley teaches the use of polyvinylpirrolidone as an outer layer comprising a cannabinoid to provide a more immediate release of the cannabinoid (paragraph 0116).
Regarding instant claims 9-12 and 15, Carly teaches its composition may be a liquid dosage compartment comprising an aqueous or semi-aqueous liquid component comprising a cannabinoid and organic co-solvents such as ethanol (paragraph 0101), lipophilic medium comprising triglycerides or oils such as borage oil (paragraph 0102) and surfactants such as sorbitan monooleate (paragraph 0138). Example 12 Table 7 further teaches the dronabinol dissolved in ethanol (solubilizer) and dispersed in sodium lauryl sulfate (surfactant).
Regarding instant claims 17 and 23, Carley teaches a plurality of pellets composition (Example 12, Table 7). Comprising a delayed release compartment and an immediate release compartment contained within the same dose unit. The immediate release compartment is a plurality of solid pellets (or microspheres) and the delayed release compartment is a plurality of solid pellets comprising a delayed release modifier coating. Wherein, the delayed release compartment contains 3.49% dronabinol (i.e. THC), dissolved in 15-65% ethanol (i.e. solubilizer) (disclosed in paragraph 0101), dispersed in 3.49% sodium lauryl sulfate (i.e. surfactant) and charged to 27.91% Neusilin (i.e. core) and coated with 5.30% ethylcellulose. According to Carley its compositions are especially suitable for conditions that are benefitted by therapeutic levels for more than about 5 hours, e.g. about 6 to about 8 hours or for as long as about 8 or about 12 hours (paragraph 0017).
A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close and where claimed ranges “overlap or lie inside ranges disclosed by the prior art” It should be noted that generally difference in concentrations do not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such a concentration is critical. See In re Alter, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Further, optimization of ranges and parameters is a routine practice that would have been prima facie obvious for the skilled artisan to employ and reasonably would expect success. “Where 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.” (see MPEP 2144.05).
Regarding instant claim 19, Carley teaches that the immediate release dosage compartment is the portion of a dosage form that releases greater than 75% of the cannabinoid contained in the portion within 60 minutes, or greater than 50% within 30 minutes in an in vitro dissolution assay (paragraph 0039) and that the release of a cannabinoid partitioned in a delayed release compartment is delayed by about any of: 100%, 150%, 200%, 300%, 400%, 500%, 600%, 700%, or 800%, compared to an immediate release medicament (paragraph 0036). Carley also discloses that a release modifier can act independently or in concert to cause the delayed release of a cannabinoid from a medicament or dosage compartment and/or that slow or delay the absorption of the cannabinoid in the gut (paragraph 0041).
Regarding instant claims 27 and 28, Carley teaches its composition is administered orally to treat cannabinoid-sensitive disorders (abstract), such as sleep apnea anxiety, stress, headache, nausea, pain (paragraph 0019).
Carley does not teach wherein prior to administration, the composition is sprinkled on food or nutrient that is solid, semi-solid, or liquid; into water; or into other types of liquid drink. Carley also does not teach a core consisting of the inert materials as listed in claims 1 and 23.
Bosse claims an oral dosage form comprising a plurality of particulates comprising a core and a layer enclosing the core, wherein said layer comprises an antiemetic (claim 1). Said antiemetic may be dronabinol, tetrahydrocannabinol and cannabinoid (claims 17). According to Bosse the capsules can be broken such that the particulates are sprinkled on soft foods and swallowed without chewing (col 52 lines 9-11). Further, Bosse teaches a particle with a sugar core, wherein at least one component is microcrystalline cellulose (col 1 lines 35-45). Also noting that a sugar core would be made of saccharides.
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 have modified the composition of Carley as disclosed by Bosse by simply substituting the sugar sphere core of Bosse with the core of Carley as both are comprised of similar compounds (i.e., saccharides). One would have been motivated to use the known technique of Bosse and sprinkle the composition of Carley into soft foods to aid in the oral delivery of dosage forms. Such a combination of using a known technique to improve a similar product in the same way is within the purview of the skilled artisan and would yield predictable results. Further it would be obvious to one with ordinary skill in the art to simply substitute the sugar sphere core with the core of Carley to obtain predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to simply substitute one known element for another to obtain predictable results.
Further, it would have been obvious to one of ordinary skill in the art before the effective filing date to manipulate and optimize the amounts of core, cannabinoids, release modifiers, surfactants and solubilizers to reach a target release profile or therapeutic window. As recognized by Carley, the skilled artisan can modify its formulation to meet a target PK profile. Examples of such modifications may include: adjusting drug to release modifier ratio; adjusting concentration of viscosity modifier (typically increasing the concentration slows release); adjusting the grade of the viscosity modifier (using a higher molecular weight polymer typically slows release); using different viscosity modifiers (separate material or combinations of materials) (paragraphs 0266-0270).
A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close and where claimed ranges “overlap or lie inside ranges disclosed by the prior art” It should be noted that generally difference in concentrations do not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such a concentration is critical. See In re Alter, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Further, optimization of ranges and parameters is a routine practice that would have been prima facie obvious for the skilled artisan to employ and reasonably would expect success. “Where 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.” (see MPEP 2144.05).
Response to Arguments
Applicant's arguments filed 08/13/2025 have been fully considered but they are not persuasive in view of the modified grounds of rejection as necessitated by amendment.
In regards to applicant’s arguments that the sugar core of Bosse and the Neusilin of Carley have different properties and would not be equivalent to one another for substitution, it is pointed out that the Neusilin US2 are used in a specific embodiment, however Carley also teaches its solid compartment may be a sugar glass compartment (claim 4) and that microspheres made from starch or chitosan may be used (paragraph 0112). Further, Bosse teaches that the sugar core is comprises sucrose or a mixture of sucrose and starch (see Bosse, col 47 lines 45-51). Using all of the teachings of Carley and Bosse together, it would be within the purview of one with ordinary skill in the art to simply substitute the starch microsphere or the sugar glass compartment of Carley with the sugar sphere of Bosse with a reasonable expectation of success. While the comparison of Neusilin to microcrystalline cellulose is appreciated, the overall teachings of Carley are broader than just the use of Neusilin as a core.
Conclusion
No claims allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/A.A.A./Examiner, Art Unit 1611