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 .
DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/06/2026 has been entered.
Status of Claims
The amendments and arguments filed on 07/06/2026 are acknowledged and have been fully considered. Claims 1 and 3-8 are now pending.
Claims 1 and 3-8 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Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn.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.
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, 3-4, 6, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Carley et al. (US 20120231083; as filed on IDS of 10/27/2020) in view of “CaCO3 templated micro-beads and -capsules for bioapplications” (Volodkin, 2014) as evidenced by NPL1 (Mydayis, 2020; screenshot of https://www.mydayis.com/adhd-treatment/how-it-works) (as submitted on IDS of 11/15/2021).
In regards to claims 1, 3-4, and 8, Carley teaches and claims medicament comprising a cannabinoid partitioned in an immediate release compartment and in a delayed release compartment ([0018], claim 1). The composition is taught to be an oral dosage ([0020]-[0023]). The cannabinoid is dronabinol (claim 17). Further, 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 ([0039]) and that the composition comprises an additional therapeutic agent, such as serotonin reuptake inhibitors or antihistamines among others ([0150]). Example 12 specifically teaches a plurality of pellets composition, wherein the immediate release compartment is a plurality of solid pellets (or microspheres) comprising dronabinol (THC) , dispersed in sodium lauryl sulfate (surfactant) and charged into Neusilin US2 (i.e. a silica core) and coated with ethylcellulose (release-controlling polymer) ([0272]).
Further in regards to claims 3-4, 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 ([0017]). The delayed release compartment maybe a solid, semisolid or liquid compartment and form a plurality of microparticles (claims 14 and 15). Carley also teaches the use of glyceryl monostearate ([0138]), soybean oil ([0102]), propylene glycol ([0130]), carboxypolymethylene ([0116]), hydroxypropylcellulose, hydroxypropyl methylcellulose ([0115]), carboxymethylcellulose, alginates ([0136]), chitosan ([0112]), acacia ([0135]), and carrageenan ([0145]), all of which are listed as gel-forming agents in the instant specification as filed (see instant specification as filed, [0019]). Carley also teaches the use of ethylcellulose ([0125]), copolymers of methacrylic acid, polyacrylates, among others ([0126]), which are listed as release-controlling polymers in the instant specification as filed (see instant specification as filed, [0091]).
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 ([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).
Carley is silent on the core of the composition comprising a calcium carbonate bead.
Volodkin teaches calcium carbonate microsphere as a core material for microparticles for drug delivery (see Volodkin, abstract). Volodkin teaches that porous calcium carbonate in the form of vaterite is a popular core for particle templating as it has a simple preparation procedure, low costs, biocompatibility, and mild decomposition conditions (see Volodkin, page 307, column 1, paragraph 4). The calcium carbonate microbeads are useful as cores and are used for loading of biological molecules (see Volodkin, pages 310-311, 2.3 bioapplications).
In regards to claims 1, 3-4, and 6, 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 formulate the composition of the instant claims using the teachings of Carley and Volodkin as Volodkin teaches that the porous calcium carbonate microcores are better than silica cores (the neusilin of Carley) as the silica cores have restricted utilization for biological applications (see Volodkin, page 307, column 1, paragraph 3) and require the use of harsh conditions for decomposition (see Volodkin, page 307, column 2, paragraph 4). Further, it is taught that the porous calcium carbonate cores have superior performance when compared to the silica cores (see Volodkin, page 311, column 1, paragraph 4). It would be obvious to one with ordinary skill in the art to combine the teachings of Carley with the porous core of Volodkin according to the known method of making porous calcium carbonate microbeads as cores (see Volodkin, 2.1 Fabrication and Properties) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Carley et al. (US 20120231083; as filed on IDS of 10/27/2020) in view of “CaCO3 templated micro-beads and -capsules for bioapplications” (Volodkin, 2014) as applied to claims 1, 3-4, 6, and 8 above, and further in view of WO 2006133941 A2 (Kupper, 2006; Machine translation provided from FIT via PE2E) as evidenced by NPL1 (Mydayis, 2020; screenshot of https://www.mydayis.com/adhd-treatment/how-it-works) (as submitted on IDS of 11/15/2021) and “An overview on in situ micronization technique – An emerging novel concept in advanced drug delivery” (Vandana et al., 2014).
The teachings of Carley and Volodkin have been described supra.
The teachings of Carley and Volodkin are silent on ratio of the pore volume to the particle size of the core.
Kupper teaches a composition comprising tetrahydrocannabinol (THC) (see Kupper, abstract) in a powdered formulation (see Kupper, page 7, paragraph 5) which can be compressed into a tablet (see Kupper, page 8, paragraph 4) or a solid, orally available, controlled-release dosage form (see Kupper page 8, paragraph 5). It is also taught that the formulation is used in an immediate release form (see Kupper, page 8, paragraph 3). Kupper also teaches that the particle size range effects the properties of the formulation (e.g. the release rate of the active agent) and teaches that the microparticles are about 0.1 to about 10 microns (see Kupper, page 22, paragraph 5) as well as having uniform size distribution from about 1 micron to about 30 microns (see Kupper, page 23, paragraph 2). MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Vandana teaches that the use of micronized drug particles is known to overcome dissolution and bioavailability problems, as well as enhancing the dissolution rate (see Vandana, abstract). Vandana teaches micronization is a term used to describe size reduction technique where the resulting particle size distribution is less than 10µ (see Vandana, page 284, introduction) and more specifically particle size of around 5 microns (see Vandana, page 287, column 1, final paragraph). Vandana teaches that the micronized particles can be used in dry powder inhalers, solids such as capsules, tablets, or pills among other applications (see Vandana, page 287; applications). Further, Vandana teaches the merits of the microparticles such as enhanced wettability, less sedimentation when creating suspensions, improved aerodynamic flow, as well as high drug load (see Vandana, page 287, merits).
In regards to claim 5, 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 formulate the composition of the instant claims using the teachings of Carley and Volodkin with Kupper, as Kupper teaches that having a particle size of 10 microns allows for the intended release rate of the active. Further Vandana teaches the multiple benefits of micronizing the particles for drug delivery, such as enhanced wettability, less sedimentation when creating suspensions, improved aerodynamic flow, as well as high drug load (see Vandana, page 287, merits) as well as enhanced dissolution rate (see Vandana, abstract). It would be obvious to one with ordinary skill in the art at the time of the effective filing date to combine the particle size of Kupper with the composition of Carley and Volodkin according to the method of micronizing taught in Kupper (see Kupper, page 22, paragraphs 6-7) to yield predictable results with a reasonable expectation of success. One with ordinary skill would be motivated to combine prior art elements according to known methods to yield predictable results.
Further, it is noted as the desired target PK profile, where the PK profile achieves a therapeutic level of a cannabinoid during a therapeutic window (see Carley, [0051]) is a variable that can be modified, among others, by adjusting geometry of the tablet (i.e. surface area to volume ratio) and tablet properties (i.e. the porosity of the tablet) (see Carley, [0348]), the PK profile changing as geometry and tablet properties is changed, the geometry and tablet properties would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed geometry and tablet properties cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, geometry and tablet properties in Carley and Volodkin to obtain the desired PK profile as taught by Carley (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). “[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.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
Claims 1, 3-4, and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Carley et al. (US 20120231083; as filed on IDS of 10/27/2020) in view of “Porous calcium phosphate glass microspheres for orthobiologic applications” (Hossain, 2018) as evidenced by NPL1 (Mydayis, 2020; screenshot of https://www.mydayis.com/adhd-treatment/how-it-works) (as submitted on IDS of 11/15/2021).
The teachings of Carley have been described supra.
The teachings of Carley are silent on the core of the composition comprising a calcium phosphate bead.
Hossain teaches that silicates and phosphates are known for being used as bioactive glass in biomedical applications (see Hossain, page 397, column 1, paragraph 2). Hossain also teaches that the calcium phosphate is in the form of a microsphere, particularly a solid core with surface porosity (see Hossain, abstract; page 399, column 1, paragraph 2; 3.2 porosity and surface area analysis). Hossain teaches that porous microspheres are known for applications such as drug delivery (see Hossain, page 397, column 1, paragraph 3).
In regards to claims 1, 3-4, and 6, 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 formulate the composition of the instant claims using the teachings of Carley and Hossain, as Hossain teaches that the phosphate glass microspheres have a known advantage of being fully degradable and having controllable resorption profiles when compared to silicate-based bioglasses (e.g. the neusilin of Carley) (see Hossain, page 397, column 1, paragraph 2). Using these teachings, it would be obvious to one with ordinary skill in the art to combine the teachings of Carley with the porous core of Hossain according to the known method of making porous calcium phosphate microbeads as cores (see Hossain, page 397, 2.1 manufacture of solid and porous calcium phosphate glass microspheres) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Carley et al. (US 20120231083; as filed on IDS of 10/27/2020) in view of “Porous calcium phosphate glass microspheres for orthobiologic applications” (Hossain, 2018) as applied to claims 1, 3-4, and 7-8 above, and further in view of WO 2006133941 A2 (Kupper, 2006; Machine translation provided from FIT via PE2E) as evidenced by NPL1 (Mydayis, 2020; screenshot of https://www.mydayis.com/adhd-treatment/how-it-works) (as submitted on IDS of 11/15/2021) and “An overview on in situ micronization technique – An emerging novel concept in advanced drug delivery” (Vandana et al., 2014).
The teachings of Carley and Hossain have been described supra.
The teachings of Carley and Hossain are silent on ratio of the pore volume to the particle size of the core.
The teaching of Kupper have been described supra.
In regards to claim 5, 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 formulate the composition of the instant claims using the teachings of Carley and Hossain with Kupper, as Kupper teaches that having a particle size of 10 microns allows for the intended release rate of the active. Further Vandana teaches the multiple benefits of micronizing the particles for drug delivery, such as enhanced wettability, less sedimentation when creating suspensions, improved aerodynamic flow, as well as high drug load (see Vandana, page 287, merits) as well as enhanced dissolution rate (see Vandana, abstract). It would be obvious to one with ordinary skill in the art at the time of the effective filing date to combine the particle size of Kupper with the composition of Carley and Hossain according to the method of micronizing taught in Kupper (see Kupper, page 22, paragraphs 6-7) to yield predictable results with a reasonable expectation of success. One with ordinary skill would be motivated to combine prior art elements according to known methods to yield predictable results.
Further, it is noted as the desired target PK profile, where the PK profile achieves a therapeutic level of a cannabinoid during a therapeutic window (see Carley, [0051]) is a variable that can be modified, among others, by adjusting geometry of the tablet (i.e. surface area to volume ratio) and tablet properties (i.e. the porosity of the tablet) (see Carley, [0348]), the PK profile changing as geometry and tablet properties is changed, the geometry and tablet properties would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed geometry and tablet properties cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, geometry and tablet properties in Carley and Hossain to obtain the desired PK profile as taught by Carley (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). “[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.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
Response to Arguments
Applicant's arguments filed 07/06/2026 have been fully considered but they are not persuasive.
In regards to applicant’s arguments that the teachings of Volodkin teaches a calcium carbonate “sacrificial core” that is removed in the preparation of the particle, it is pointed out that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In the instant case, there are multiple benefits of using a calcium carbonate core in a particle, such as low costs, biocompatibility, and simple preparation (see Volodkin, page 307, column 1, paragraph 4). Further Volodkin teaches that the porous calcium carbonate microcores are better than silica cores (the neusilin of Carley) as the silica cores have restricted utilization for biological applications (see Volodkin, page 307, column 1, paragraph 3) and require the use of harsh conditions for decomposition (see Volodkin, page 307, column 2, paragraph 4). Further, it is taught that the porous calcium carbonate cores have superior performance when compared to the silica cores (see Volodkin, page 311, column 1, paragraph 4). It would be within the purview of one with ordinary skill in the art to use the teachings of Volodkin and combine them with the teachings of Carley to formulate a particle as instantly claimed as the benefits of a calcium carbonate core versus a silica core are well known in the art. Applicant further argues that the finished pharmaceutical composition does not comprise the calcium carbonate template, however it is noted that one with ordinary skill in the art would understand that it is taught that the core is made of calcium carbonate. "The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983)
In regards to applicant’s argument that Hossain does not teach a pharmaceutical composition, rather a method of making microspheres (i.e., is non-analogous art), although Hossain is not in the same field of endeavor, it is reasonably pertinent to the problem to be solved with regards to using porous glass microspheres for use in drug delivery. A reference is analogous art to the claimed invention if: (1) the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem); or (2) the reference is reasonably pertinent to the problem faced by the inventor (even if it is not in the same field of endeavor as the claimed invention). Note that "same field of endeavor" and "reasonably pertinent" are two separate tests for establishing analogous art; it is not necessary for a reference to fulfill both tests in order to qualify as analogous art. See Bigio, 381 F.3d at 1325, 72 USPQ2d at 1212. When more than one prior art reference is used as the basis of an obviousness rejection, it is not required that the references be analogous art to each other. See Sanofi-Aventis Deutschland GMbH v. Mylan Pharms. Inc., 66 F.4th 1373, 1380, 2023 USPQ2d 552 (Fed. Cir. 2023) and Corephotonics, Ltd. v. Apple Inc., 84 F.4th 990, 1007, 2023 USPQ2d 1202 (Fed. Cir. 2023). In the instant case, Hossain teaches that porous microspheres are known for applications such as drug delivery (see Hossain, page 397, column 1, paragraph 3). Hossain also teaches that the calcium phosphate is in the form of a microsphere, particularly a solid core with surface porosity (see Hossain, abstract; page 399, column 1, paragraph 2; 3.2 porosity and surface area analysis) (i.e., a porous microsphere). Applicant argues that the art would lend one with skill to use porous microspheres, not calcium phosphate beads, however Hossain teaches that the porous glass beads are calcium phosphate glass beads (see Hossain, abstract; page 399, column 1, paragraph 2; 3.2 porosity and surface area analysis). Applicant further argues that it has not been established why one with ordinary skill in the art would look to the teachings of Hossain when selecting the cores of Carley’s pharmaceutical particles, but it is pointed out that one with ordinary skill in the art would know that the calcium phosphate glass beads are known to be used as cores for drug delivery and have the benefits taught in Hossain. Using these teachings, it would be obvious to one with ordinary skill in the art to combine the teachings of Carley with the porous core of Hossain according to the known method of making porous calcium phosphate microbeads as cores (see Hossain, page 397, 2.1 manufacture of solid and porous calcium phosphate glass microspheres) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results. Applicant continues to argue that these benefits are discussed in the context of orthobiologic materials, but again it is taught in Hossain that the porous glass beads are used for drug delivery and such it would be obvious to one with ordinary skill in the art that the benefits listed would also be relevant to their use in drug delivery too.
In regards to applicant’s arguments against the rejections of Carley in view of Volodkin and Kupper and Carley in view of Hossain and Kupper, the rejections are maintained as the main arguments that applicant presented have been rebutted above. As such, the rejections of record are maintained.
Conclusion
No claims allowed.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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
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