DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after September 27, 2024, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
Receipt is acknowledged of Applicants’ claimed invention filed on 09/27/2024 in the matter of Application N° 18/899,322. Said documents are entered on the record. The Examiner further acknowledges the following:
Thus, claims 1-12 represent all claims currently under consideration.
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 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Schlossberg et al. (WO2017165612A1A1), in view of Bagga et al. (US20190099515A1).
Regarding claim 1, Schlossberg et al. teach a method for producing substantially spherical calcium phosphate, magnesium phosphate, or strontium phosphate particles by mixing a dry powder basic anionic reagent with a liquid acidic cationic reagent to form a slurry, dehydrating the slurry to produce a dry cake, reducing the dry cake to a fine powder comprising calcium phosphate, magnesium phosphate, or strontium phosphate particles, adding an initiator to the fine powder to produce a reaction mixture, adding a solution comprising colloidal silica to the reaction mixture to form a paste, and subjecting the paste to dual asymmetric centrifugation (DAC) to produce substantially spherical particles (See paragraphs 0008, 0043, 0049, 0052, and claim 9). Schlossberg et al. further teach dehydrating the material through a drying process comprising microwave irradiation followed by oven drying (See claim 12).
It would have been obvious to one of ordinary skill in the art, prior to the instant effective filing date at the time the invention was made to employ the method taught by Schlossberg et al., including providing a mixture comprising a biological active powder, magnesium phosphate, an initiator, and a colloidal silica solution, rotating the mixture using dual asymmetric centrifugation for a predetermined period time, and drying the resulting material to obtain substantially spherical granules. Optimizing the duration of the DAC mixing step would have been a routine matter of process optimization, as the appropriate mixing time is a result-effective variable that would have been selected by one of ordinary skill in the art to achieve the desired particle morphology and processing characteristics with a reasonable expectation of success.
Regarding claim 2, Schlossberg et al. teach in one non-limiting example, magnesium oxide (MgO) is utilized as the reaction initiator (See paragraph 0047).
Regarding claim 3, Schlossberg et al. teach a method of producing substantially spherical particles, the method comprising at least one of strontium phosphate, to dual asymmetric centrifugation (DAC) to produce substantially spherical particles (See paragraph 0006).
Regarding claim 4, Schlossberg et al. teach in certain embodiments, DAC processing steps that each include 800-1900 revolutions per minute for 20-85 seconds (See paragraph 0007).
Regarding claim 5, Schlossberg et al. teach that the drying (dehydration) step may be carried out using one or more dehydration techniques selected from heating in an oven, microwave irradiation, iterative washing with a low vapor pressure solvent, or lyophilization by sublimation under vacuum (See claim 11). Heating in an oven inherently involves evaporation of liquid from the material under an air atmosphere or another suitable gaseous environment, while lyophilization is likewise a well-known evaporation/dehydration process conducted under controlled atmospheric conditions.
It would have been obvious to one of ordinary skill in the art, prior to the instant effective filing date at the time the invention was made to perform the drying step using an evaporation process under ambient air, a pressurized flow of air, an ambient inert gas, or a pressurized flow of inert gas, as these represent well-known and routine drying environments that could be selected based on the desired drying rate, oxidation control, or processing efficiency. Selecting a particular gaseous drying environment would have been an obvious matter of routine optimization, yielding no more than the predictable result of removing moisture from the granules.
Regarding claim 6, Schlossberg et al. teach that the dehydration (drying) step may be carried out using one or more dehydration techniques selected from heating in an oven, microwave irradiation, iterative washing with a low vapor pressure solvent, and lyophilization by sublimation under vacuum (See claim 11). Lyophilization is a drying process performed under vacuum conditions to remove solvent from the material.
It would have been obvious to one of ordinary skill in the art, prior to the instant effective filing date at the time the invention was made to perform the drying step under vacuum conditions, as expressly taught by Schlossberg et al., because vacuum drying is a known dehydration technique that facilitates efficient solvent removal while preserving the integrity and morphology of the resulting substantially spherical granules. Employing vacuum conditions would have predictably produced the desired dried granules with a reasonable expectation of success.
Regarding claim 7, Schlossberg et al. teach that the dehydration (drying) step may be performed using one or more dehydration techniques selected from heating in an oven, microwave irradiation, repeatedly washing with a low vapor pressure solvent, or lyophilization by sublimation under vacuum (See claim 11). The repeated washing with a low vapor pressure solvent facilitates evaporation of the solvent and removal of moisture from the material during the drying process.
`it would have been obvious to one of ordinary skill in the art, prior to the instant effective filing date at the time the invention was made to perform the drying step by repeatedly washing the material with a solvent having a low vapor pressure, as expressly taught by Schlossberg et al., because this is a recognized dehydration technique for removing residual liquid while preserving the morphology and integrity of the substantially spherical granules. Employing this drying process would have predictably yielded the desired dried granules with a reasonable expectation of success.
Regarding claim 8, Schlossberg et al. teach that the drying (dehydration) step may be performed using one or more dehydration techniques selected from heating in an oven, microwave irradiation, repeatedly washing with a low vapor pressure solvent, or lyophilization by sublimation under vacuum (See claim 11). Heating in an oven constitutes an evaporation process in which liquid is removed from the material through the application of heat.
`it would have been obvious to one of ordinary skill in the art, prior to the instant effective filing date at the time the invention was made to perform the drying step using a heating process, as expressly taught by Schlossberg et al., because heating is a conventional and well-established evaporation technique for removing moisture or solvent from particulate materials. Employing a heating process would have predictably produced dried substantially spherical granules while preserving their desired physical properties, with a reasonable expectation of success.
Regarding claims 9 and 12, Schlossberg et al. teach substantially spherical granules comprising an outer shell including magnesium phosphate and nano-sized (colloidal) silica. Wherein the granules are produced by dual asymmetric centrifugation. However, Schlossberg et al. do not expressly disclose administering the granules for bone regeneration or that the granules include a bioactive core comprising calcium phosphate including hydroxyapatite and beta-tricalcium phosphate and/or bioactive glass having the claimed pore architecture.
Bagga et al. teach administering bioactive porous implants for bone regeneration, wherein the implants include bioactive glass and may comprise combinations of nanopores, macropores, mesopores, and micropores. Bagga et al. explain that these porous structures facilitate bone ingrowth, vascularization, and enhanced osteointegration (See paragraph 0147).
It would have been obvious to one of ordinary skill in the art, prior to the instant effective filing date at the time the invention was made to employ the spherical granules of Schlossberg et al. in a bone regeneration application as taught by Bagga et al., including a bioactive core comprising bioactive glass, because Bagga et al. demonstrate that porous bioactive glass materials promote bone regeneration and osteoconductivity. `it would have been obvious to one of ordinary skill in the art, prior to the instant effective filing date would have reasonably expected that combining the known spherical granule manufacturing process of Schlossberg et al. with the known bioactive glass bone graft materials of Bagga et al. yield a porous bone regeneration material with predictable therapeutic benefits.
Regarding claim 10, Schlossberg et al. teach a slurry comprising a co-precipitate of monosodium phosphate or disodium phosphate, which correspond to sodium phosphate monobasic (NaH2HPO4) and sodium phosphate dibasic (Na2HPO4), respectively (See paragraph 0011 and claim 23). Accordingly, Schlossberg et al. teach a bioactive core that includes at least one of sodium phosphate dibasic and sodium phosphate monobasic.
`it would have been obvious to one of ordinary skill in the art, prior to the instant effective filing date at the time the invention was made to employ sodium phosphate dibasic and/or sodium phosphate monobasic in the bioactive core, as expressly taught by Schlossberg et al., because these phosphate salts are known reactants for forming calcium phosphate and magnesium phosphate compositions and would have predictably contributed to the preparation of substantially spherical bioactive granules with a reasonable expectation of success.
Regarding claim 11, Schlossberg et al. teach a method of producing substantially spherical bioactive granules comprising a bioactive core that includes sodium phosphate monobasic and/or sodium phosphate dibasic, an initiator, a colloidal silica solution, dual asymmetric centrifugation, and a drying step. However, Schlossberg et al. do not expressly disclose that the bioactive glass includes 45S5 or S53P4.
Bagga et al. teach bioactive porous bone graft implants incorporating bioactive glass compositions including 45S5 and S53P4 (See paragraph 0096). Bagga et al. further discloses that the engineered implant, including its outer shell, may be coated with a glass, glass-ceramic, or ceramic coating to enhance bioactivity and osteoconductive performance (See paragraphs 0011, 0096, 0106, and 0110).
It would have been obvious to one of ordinary skill in the art, prior to the instant effective filing date at the time the invention was made to modify the method of Schlossberg et al. by utilizing the bioactive glass compositions 45S5 and/or S53P4 taught by Bagga et al., because these materials were well known for promoting bone regeneration, osteoconductivity, and biological integration in bone graft applications. One of ordinary skill in the art, prior to the instant effective filing date would have had a reasonable expectation that incorporating these recognized bioactive glass compositions into the granules produced by the method of Schlossberg et al. would have predictably enhanced the biological performance of the resulting granules while preserving the known advantages of Schlossberg et al.’s granule manufacturing process.
Conclusion
No claim is allowed.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax, can be reached at telephone number (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KIMBERLY BARBER/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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