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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/17/2026 has been entered.
Status of Claims
The arguments filed on 08/17/2026 are acknowledged and have been fully considered. Claims 1-3 and 6-13 now pending. Claims 4-5 are cancelled; claims 12 and 13 are amended.
Claims 1-3 and 6-13 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Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn.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, 6-9, 10, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018035030 A1 (White, et al, 2018) in view of “CaCO3 templated micro-beads and -capsules for bioapplications” (Volodkin, 2014).
In regards to claims 1-3 and 6, White teaches an extended-release composition such as an extended-release bead multiparticulate comprising a fat-soluble active for oral administration(see White, abstract; paragraph 0013). White teaches that the fat-soluble active are cannabinoids, vitamins, carotenoids, polyunsaturated fatty acids, docosahexaenoic acid, or combinations thereof (see White, paragraph 0015). Further, White specifically teaches the use of tetrahydrocannabinols (i.e., dronabinol) (see White, paragraph 0023-0024). White teaches that the extended-release beads comprise an inert core made of at least one of celluloses, starches, saccharides, or mixtures thereof (see White, paragraph 0028). White teaches the use of a surfactant in the extended-release beads (see White, paragraph 0060). White teaches the use of soybean oil (see White, paragraph 0074), glyceryl monooleate, glycerol monostearate (see White, paragraph 0038), hydroxypropylmethylcellulose, hydroxypropyl cellulose, carboxymethyl cellulose sodium (see White, paragraph 0057), acacia sodium alginate (see White, paragraph 0062), sodium alginate (see White, paragraph 0064), chitosan (see White, paragraph 0057), and carrageenans (see White, paragraph 0049). In regards to the release of the actives, White teaches that not less than 80% of the fat-soluble active is released in about 12 hours (see White, paragraph 0026).
In regards to claim 7, White teaches that the beads have a nutrient layer comprising the fat-soluble active along with a vitamin or mineral, as well as a “performance enhancing component” (see White, paragraphs 0030-0031). The nutrient layer is on the inert core (see White, paragraph 0028).
In regards to claims 8-9, White teaches the composition comprises ethyl cellulose (see White, paragraph 0062), crosslinked polyacrylic acids, polyvinyl alcohol, as well as combinations thereof (see White, paragraph 0057).
White is silent on the core of the composition comprising a calcium carbonate bead.
Volodkin teaches calcium carbonate microspheres 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, 6-9, 10, and 12, 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 White and Volodkin as Volodkin discloses a simple preparation procedure, low costs, biocompatibility, and mild decomposition conditions (see Volodkin, page 307, column 1, paragraph 4). Further, the calcium carbonate microbeads are useful as cores and are used for loading of biological molecules (see Volodkin, pages 310-311, 2.3 bioapplications). It would be obvious to one with ordinary skill in the art to combine the teachings of White 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.
Claims 1-3, 6-9, 11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018035030 A1 (White, et al, 2018) in view of “Porous calcium phosphate glass microspheres for orthobiologic applications” (Hossain, 2018).
The teachings of White have been described supra.
The teachings of White 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, 6-9, 11, and 13, 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 White and Hossain, as Hossain teaches that the phosphate glass microspheres have a known advantage of being fully degradable and that having a porous structure for microparticles is very advantageous, particularly for drug delivery (see Hossain, page 397, column 1, paragraph 3). Using these teachings, it would be obvious to one with ordinary skill in the art to simply substitute the inert core of White with the porous core of Hossain 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.
Response to Arguments
Applicant's arguments filed 08/17/2026 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, Volodkin teaches that calcium carbonate microbeads are useful as cores and are used for loading of biological molecules (see Volodkin, pages 310-311, 2.3 bioapplications). Volodkin also teaches that 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). It would be obvious to one with ordinary skill in the art to combine the teachings of White 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. 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).
Applicant argues that no reason is given to substitute one bead for another, but the argument in the rejection isn’t one of direct substitution, but rather that one with ordinary skill in the art would reasonably combine the teachings of White and Volodkin in order to achieve the in the instant composition. In the instant case, the benefits of using the calcium carbonate beads is discussed in the rejection above.
In regards to applicant’s argument that Hossain or any other prior art does not teach an oral composition, it is pointed out that White does teach orally administered compositions (see White, paragraphs 0004, 0013, 0085). Further, Hossain does teach that the microspheres are used via minimally invasive surgical injection procedures, however the full context of that statement is that “Microspheres (i.e. spherical particles) produced from polymers, bioactive glasses, and ceramics exhibit greater advantages over irregular-shaped particles such as improved flow properties, which would be particularly beneficial for biomedical applications (for example, by enabling improved delivery via minimally invasive surgical injection procedures)” (see Hossain, page 397, column 1, paragraph 3). The injections are mentioned as an example of a route of administration, not as the only method of administration. Further, while it is taught that the microspheres are taught to deliver stem cells, it is also taught that porous microspheres are known to be used for drug delivery as well (see Hossain, page 397, column 1, paragraph 3). "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).
Applicant also argues that Hossain is non-analogous art, as method of making. 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 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 White’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 White 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.
Applicant argues that not all routes of drug delivery are equivalent and that nothing in the cited art teaches that White can be modified to use calcium phosphate glass microspheres while exhibiting the claimed release characteristics, it is pointed out that the claims are drawn to a composition for oral administration, which is the same as the art. While other routes of administration may not be equivalent the art does teach the claimed method of administration. Further, even if the art does not teach directly that the combination of White and Hossain would have the release characteristics as claimed, one with ordinary skill in the art would reasonably expect the composition of the prior art to behave in a manner identically to the instant composition as they are composed of identical compounds in an identical way. As the combination of White and Hossain would yield an identical composition as instantly claimed, the properties, such as the argued release properties, of the composition would be the same. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658. As the prior art teaches an identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
As such, the rejections 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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