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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/26/2026 has been entered.
Status of Claims
The amendments and arguments filed on 05/26/2026 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, 19, 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Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn.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 § 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 on a surface of 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.
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 microcrystalline spheres and sugar spheres.
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 (see Bosse, claim 1). Said antiemetic may be dronabinol, tetrahydrocannabinol and cannabinoid (see Bosse, claims 17). According to Bosse the capsules can be broken such that the particulates are sprinkled on soft foods and swallowed without chewing (see Bosse, col 52 lines 9-11). Further, Bosse teaches a particle with a sugar core, wherein at least one component is microcrystalline cellulose (see Bosse, col 1 lines 35-45).
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 05/26/2026 have been fully considered but they are not persuasive in view of the modified grounds of rejection as necessitated by amendment.
In regard to applicant’s argument that example 12 of Carley does not contain the claimed coated-core structure, it is pointed out that while example 12 was previously cited as it was relevant to the teachings of the claims before the current amendments. However, along with that the teachings of example 12, it was also noted that 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. Using these teachings of Carley, it would be within the purview of one with ordinary skill in the art to envisage a coating comprising both the cannabinoid and the release modifier. In regards to applicant’s argument that this discussion does not supply the missing claimed core and coating, it is pointed out that the rejection is made over Carley in view of Bosse. The combination of both references together teach the claimed composition as discussed in the rejection above.
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 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.
In regard to applicant’s arguments against Mydayis, it is pointed out that the reference is used to show that the structure of the claims is known in the art. It is not used for the basis of the rejection, only as an evidentiary piece of art.
Conclusion
No claims allowed.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/A.A.A./Examiner, Art Unit 1611
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