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
Amendment filed on 08/19/2025 is acknowledged.
Claims 4, 8-9, and 13 are cancelled.
Claims 1-3, 5, 10, 12 are amended. No new matter was added.
Claims 1-3, 5-7, and 10-12 are pending and being examined on merits herein.
Priority
The instant application, filed on 12/13/2021, is a 371 of PCT/CN2020/088209, filed on 04/30/2020.
Withdrawn Objections and Rejections
Previous claim objections and rejections under 35 U.S.C. 112 in non-final office action filed on 06/03/2025 are withdrawn, because applicants’ claim amendments filed on 08/19/2025 have overcome these objections/rejections.
New Rejections
The following set of rejection overrides the previous rejections, necessitated by applicant’s claim amendments filed on 08/19/2025.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 5-7, and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Zhu et al. (CN110818270, 02/21/2020, machine translated English copy in record or 06/03/2025), in view of Byun (KR20080090808, 10/09/2008, machine translated English copy uploaded, PTO-892) and Wang et al. (CN107261203, 10/20/2017, machine translated English copy in record of 06/03/2025).
Zhu teaches a method for preparing bioglass powder with different particle sizes and biological activity (Abstract). Zhu teaches that silicate-based bioactive glass (Bioactive glass, BG) is a bioactive ceramic material with excellent bioactivity, biocompatibility, biodegradability and other properties, and the prepared bioglass materials require a specific surface area and various pore sizes to overcome challenges in clinical applications on medical and health issues [0004] (corresponding to instant claims 2, 10-12).
Zhu indicates that the chemical composition of the bioglass powder is convenient and adjustable, that is, it is adjusted by controlling the type and quality of the solute (tetraethyl orthosilicate, triethyl phosphate, calcium nitrate tetrahydrate, and other nitrates such as manganese nitrate tetrahydrate (MnNT), copper nitrate trihydrate (CuNT), cobalt nitrate hexahydrate (CoNT), zinc nitrate hexahydrate (ZnNT), iron nitrate nonahydrate (FeNT), magnesium nitrate hexahydrate (MgNT), cerium nitrate hexahydrate (CeNT), strontium nitrate (SrNT) added to the solvent when preparing the precursor solution (e.g., Claim 1-3; [0017]; [0025]) and preferably, the mass percentage of all solutes in the precursor solution is 5-35% (e.g., Claim 5; [0018]). As common knowledge in chemistry, chemical compounds in different hydration forms, e.g., tetrahydrate, trihydrate, or hexahydrate do not change compound properties in a solution while weighing amounts for target concentrations are adjusted in a composition.
Zhu teaches that bioglass powders with different particle size ranges can be achieved by adjusting three process parameters: gas flow rate, feed rate, and mass concentration of precursor solution, and changing the mass concentration of the precursor solution means that the viscosity of the solution will change, while other conditions remain unchanged, and that the higher the mass concentration, the wider the particle size range of the obtained bioglass powder will be and overall particle size will also increase [0023]. Zhu points out that the preferred embodiment cannot be used to limit the scope of rights of the invention, and for ordinary technicians in the technical field, several improvements and changes can be made without departing from the principle of the invention, and the improvements and changes are regarded as the protection scope of the scope of the invention (e.g., [0121]). Zhu exemplifies compositions in Examples 5-7, indicating methods and components of compositions are conveniently adjustable [0083-0109], and selecting some components out of the many taught by Zhu is obviousness. Moreover, because adjusting the mass percentage of components can result in powder size changes based upon Zhu’s teaching, adjusting tetraethyl orthosilicate or other components due to intended needs of powder size ranges is a routine experimentation in the field of art, and Zhu’s invention is not limited by examples and preferred embodiments. “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), and "A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments." Merck & Co. v.Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), and "Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments." In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). Therefore, Zhu teaches all the components except yeast selenium in instant claims 1 and 3.
Zhu indicates the main traditional methods for preparing bioglass powder are melting method and sol-gel method (acid catalysis, co-precipitation) while it discloses an improved method from the perspective of preparation cycle and economy [0005]. Zhu describes the method comprising the following steps in abstract and in specification: adding a certain amount of tetraethyl orthosilicate into an acidic solution and stir to hydrolyze until the solution becomes clear [0010] (corresponding to pre-hydrolyzing in instant claim 3); adding a certain amount of triethyl phosphate, and continuing stirring and hydrolyzing [0011]; adding a certain amount of calcium nitrate tetrahydrate, and carrying out stirring and hydrolyzing to obtain a precursor solution [0012] (shown as adding other ingredients and stirring to form a sol in instant claim 3); carrying out spray drying on the precursor solution to obtain precursor powder [0013] (as aging the sol to form a gel, drying to obtain powder in instant claim 3); calcining the precursor powder at a certain temperature, and naturally cooling the precursor powder to obtain the bioglass powder [0014] (calcined the powder to obtain the assembled jade activation material as in instant claim 3). Zhu specifies that preferably the acidic solution in pre-hydrolyzing tetraethyl orthosilicate step is a hydrochloric acid or nitric acid solution with a pH of 1-3 ([0014]; Claim 2). Zhu illustrates the preparation method in detailed steps in examples 1-8 [0041-0117]. As discussed above, Zhu points out that the preferred embodiment cannot be used to limit the scope of rights of the invention, and for ordinary technicians in the technical field, several improvements and changes can be made without departing from the principle of the invention, and the improvements and changes are regarded as the protection scope of the scope of the invention (e.g., [0121]). Zhu exemplifies compositions in Examples 5-7, indicating methods and components of compositions are conveniently adjustable [0083-0109], and therefore, adjusting components, e.g., eliminating triethyl phosphate, in the process can be routinely experimented.
Zhu specifies that the molar ratio of M : Ca : Si : P in the precursor solution is 0-10 : 5-45 : 50-80 : 5, wherein M is at least one of Mn, Cu, Co, Zn, Fe, Mg, Ce, and Sr ([0016]; Claim 4). Taking molecular weights of Si, Ca, Mg, Zn as roughly 28, 40, 24, 63 g/mol in a total 100 moles per liter solution into calculation, the molar ratio results in Si is 28 g/mol * (50 to 80 mol/L) = 1.4 to 2.24 g/mL =1,400 -2,240 ug/mL, Ca is 200-1,800 ug/mL, Mg is 0-240 ug/mL, Zn is 0-630 ug/mL (corresponding to concentrations in instant claim 2).
Zhu indicates in example 1 [ 0041], 13.4 g of tetraethyl orthosilicate is dissolved in 340 g hydrochloric acid at room temperature for 1 hour (overlapping time 20-60 min as recited in instant claim 5) [0042] (=340 g/ 36.46 g.mol-1= ~9 mol ) while the bioglass precursor solution was indicated as wt. 5% with the total components at 357.66 g (calculated as: 13.4 g tetraethyl orthosilicate + 340 g hydrochloric acid + 1.46 g triethyl phosphate + 2.80 g calcium nitrate tetrahydrate = 357.66 g, based on ingredient details [0041-0044]), thus the solution amount is 357.66 g /5% = 7,153 g, or about 7,153 ml when considering water density is 1 g/ml, that results in hydrochloric acid concentration 9 mol/7.153 L = about 1.25 M of acid, overlapping with the acid solution molar concentration range 1-2 mol/L in instant claim 5. Considering HCl (molar volume is 30.624 ml/mol, molecular weight is 36.46 g/mol) 340 g equals to 285.6 mL solution. Therefore, the molar ratio can be calculated as tetraethyl orthosilicate 13.4 g /(MW 208.33 gmol-1)=0.064 : water 0.2856 = about 1 : 4.5 (corresponding to the molar ratio 1:8 -1:12 in instant claim 5).
Zhu points out the spray drying of feed temperature at 180-220°C, inlet air temperature of 180-220°C, feed rate of 1.5-6.0 ml/min, and gas flow rate of 250-1100 L/h [0019], the particle size of the bioglass powder is in the range of 450 nm-60 um [0020], the precursor powder is calcined at 500-800 °C for 3-6 hours and then naturally cooled down to room temperature to obtain the bioglass powder [0022] (corresponding to instant claim 7).
Zhu does not teach yeast selenium as recited in instant claim 1, and it does not specify the jade activation material surface area of 79.6-132.5 m2.g-1, a porosity of 43%-65% as recited in instant claim 2. Zhu does not mention a dispersant is added into the preparation method as recited in instant claim 3 and it is selected from polyvinyl alcohol, glycerol, glycerol glucose, polyethylene glycol-400, polyethylene glycol-600, polyethylene glycol-1000, polyethylene glycol-2000 as recited in instant claim 6.
Byun teaches selenium-containing composition for healthy skin and indicates that selenium has antioxidant power of 1,970 times that of natural vitamin E, providing anti-aging effect (e.g., Pg. 5, middle paragraph). Byun exemplifies composition with 2.0% selenium yeast (containing 0.1% or more of selenium) (e.g., Abstract; Pg. 3, middle paragraph).
Wang teaches a nano biological active glass material and preparation method, dissolving tetraethoxysilane (same as tetraethyl orthosilicate) in an ethanol solution, adjusting the pH by using nitric acid, adding triethyl phosphate, zinc nitrate and a template agent, mixing to obtain a sol solution, mixing calcium nitrate and deionized water, adding a dispersing agent, obtaining a dispersion, mixing the sol solution and the dispersion, adjusting the pH by using ammonia water, standing, centrifuging to obtain precipitates, finally freeze drying the precipitates, calcining, cooling, and discharging the material, thus obtaining the nano biological active glass material. The biological active glass prepared by the invention has the characteristics of uniform particle size, good dispersity, high porosity and large specific area, can effectively improve the biological activity of the material, has relatively good drug loading capacity and is an ideal medical material (Abstract). Wang specifies that the cage -like microsphere structure is prepared by sintering with a template as a core support, a sol prepared from tetraethyl orthosilicate, triethyl phosphate, zinc nitrate, and calcium nitrate as a skeleton, and a dispersant as a shell [0012] with the molar ratio of tetraethyl orthosilicate, triethyl phosphate, zinc nitrate and calcium nitrate is (60-80): (8-10): (1-2): (16-36) [0014].
Wang shows the preparation in detail as the following: Take 0.6-0.8 mol of ethyl orthosilicate, add it to 2.4-3.6 L of 25% ethanol solution, stir at 300-400 r/min for 10-20 min, and adjust the pH to 0.8-1 .0 with nitric acid, then add 0.08-0.10 mol of triethyl phosphate, 0.01-0.02 mol of zinc nitrate, 60-90 g of template agent, continue stirring for 20-30 min to obtain a sol solution, take 0.16-0.36 mol of calcium nitrate, add it to 1.8-2.4 L of deionized water, stir at 300-400 r/min for 20-30 min, then add 240-360 g of dispersant, continue stirring for 20-30min (overlapping with the time in instant claim 6) to obtain a dispersion, drop the sol solution into the dispersion at 5-10 mL/min (resulting in concentration of dispersant amount range 240 g/ (3.6+2.4)L to 360 g/(1.8+2.4)L = 0.04 – 0.07 g/mL, corresponding to dispersant amount in instant claim 6), and continue stirring at 300-400 r/min until the dropwise addition is completed, then add ammonia water to adjust the pH to 12.0-12.5, let it stand for 1-2h, then centrifuge to obtain a precipitate, place the precipitate in a vacuum freeze drying oven, dry it at -30 - -20°C for 20-24h to obtain a freeze-dried powder, place the freeze-dried powder in a muffle furnace, heat it to 600-650°C at 1-5°C/min, calcine it for 4-6h, cool it to room temperature and then discharge it to obtain a nano bioactive glass material [0026]. The template agent is one or two of chitosan, gelatin, glucose and maltose. The dispersant is one of polyvinyl alcohol P6000, polyvinyl alcohol P10000 and polyvinyl alcohol P20000, and the dosage is 40 to 120 times the mass of zinc nitrate [0015, 0026] (corresponding to instant claims 3 and 6). Wang shows the product has specific surface area of 860, 950, 1040 m2/g and apparent porosity at 87.5, 89,6, 91.4% for examples 1-3 respectively ([0035]; Table 1).
As MPEP 2112.01.II. states that "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable, for this instance, Zhu and Wang teaches the biologically active bioglass compositions comprising same compounds and prepared by modified or improved sol-gel method same as instant invention, therefore, the bioglass material is jade activation material as inherited property.
It is prima facie obvious for an artisan with ordinary skill in the art prior to filing date to combine teachings from Wang and Zhu of the bioglass composition and preparation and add powerful antioxidant component yeast selenium taught by Byun to arrive at current invention. Because Zhu points out the chemical composition of the bioglass powder is convenient and adjustable [0017], while Wang shows slightly different compositions with dispersant and Byun teaches all the beneficial features of selenium, it would motivate a scientist with ordinary skill in the art to adjust and optimize percentages or molar ratios, and add selenium and dispersant in the preparation for improved outcome. This renders obviousness as “use of known technique to improve similar devices (methods, or products) in the same way” or as “applying a known technique to a known device (method, or product) ready for improvement to yield predictable results”. See MPEP §2143. (I)(C) and (I)(D). Moreover, It is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (MPEP §2144.07). See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
Differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). As discussed above, Zhu points out that the composition is conveniently adjustable, and Wang also states that if bioactive glass powder is desired, the frozen glass can be fractured into small fragments by pouring the molten glass into a liquid medium and it can be followed by grinding and size separation steps to achieve a powder within a specific size range [0005]. Zhu teaches changing the mass concentration of the precursor solution means that the viscosity of the solution will change, while other conditions remain unchanged, and that the higher the mass concentration, the wider the particle size range of the obtained bioglass powder will be and overall particle size will also increase [0023]. Zhu points out that the preferred embodiment cannot be used to limit the scope of rights of the invention, and for ordinary technicians in the technical field, several improvements and changes can be made without departing from the principle of the invention, and the improvements and changes are regarded as the protection scope of the scope of the invention (e.g., [0121]). Based on teaching of Zhu and Wang, adjustments of the weight percentage tetraethyl orthosilicate to higher than preferred embodiments in prior art, and adjusting the sol aging/drying temperature and time have been known as routine experimentation in bioglass preparation. “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), and "A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments." Merck & Co. v.Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), and "Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments." In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). Furthermore, various drying temperatures depending on variations in aging and drying methods with different duration of time can be carried out, e.g., freeze drying in Wang, or spray drying in Zhu, and they do not change the final product property. MPEP §2144.05(I) states that “A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.” See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). “[i]t would have been prima facie obvious for one of ordinary skill in the art to optimize additive amount through nothing more than “routine experimentation,” because of a reasonable expectation of success resulting from the optimization for desirable features of intended use of the composition (MPEP §2144.05 (II)). See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969).
Moreover, claims 3 and 5-7 are product-by-process claims, the patentability is based on the product itself. If the product is the same as a product from the prior art, the claims are unpatentable. The MPEP indicates that the process of making is only relevant “if the process by which a product is made imparts ‘structural and functional differences’ distinguishing the claimed produce from the prior art”. See MPEP 2113:"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Response to Arguments
Applicant only amended claims. The office action presented above responds to the amendments in detail.
Conclusion
No claim is 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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/DX.Z./Examiner, Art Unit 1616
/ERIN E HIRT/Primary Examiner, Art Unit 1617