DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s amendment and response filed on 8/11/2026 have been received and entered into the case. Claims 2, 11, 14-22, and 32-33 have been canceled, Claims 34-35 have been added. Claims 1, 3-10, 12-13, 23-31, and 34-35 are pending, Claims 1 and 3-9 have been withdrawn, and Claims 10, 12-13, 23-31, and 34-35 have been considered on the merits. All arguments have been fully considered.
Withdrawn Rejections
Rejections of Claims 10-13, 23-29 and 31-33 under 35 U.S.C. 103 as being unpatentable over Dzionek et al (Electronic Journal of Biotechnology. 2016;23:28-36.) in view of Ruf et al (US 8,637,300 B2; 1/28/2014.), Hust et al (US 2022/0145228 A1; 5/12/2022.), and Escobar et al (J Microbiol Biotech Food Sci. 2021;10(4):620-625.) are withdrawn in view of applicant’s amendments.
Rejections of Claim 30 under Dzionek et al (Electronic Journal of Biotechnology. 2016;23:28-36.) in view of Ruf et al (US 8,637,300 B2; 1/28/2014.), Hust et al (US 2022/0145228 A1; 5/12/2022.), Escobar et al (J Microbiol Biotech Food Sci. 2021;10(4):620-625.), and Gómez-Tena et al (Conference: XII FORO GLOBAL DEL RECUBRIMIENTO CERÁMICO. QUALICER 2014.) are withdrawn in view of applicant’s amendments.
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 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 of this title, 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 10, 12-13, 23-29, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Ruf et al (US 8,637,300 B2; 1/28/2014.) in view of Escobar et al (J Microbiol Biotech Food Sci. 2021;10(4):620-625.) and Dzionek et al (Electronic Journal of Biotechnology. 2016;23:28-36.).
The instant claims recite a method for processing a microorganism for delivery to a site of use, the method comprising: culturing the microorganism in the presence of a solid, porous substrate comprising a glass-based material, the substrate comprising a foamed glass ceramic, the substrate including an open-celled porosity such that passageways extend from a first external surface to an interior and to a second external surface, the culturing being conducted for at least 24 hours following inoculation of the solid, porous substrate with the microorganism, wherein a biofilm comprising the microorganism embedded in a microbially produced matrix of extracellular polymeric substances is formed on and adhered to glass surfaces of the foamed glass ceramic; and lyophilizing the adhered microorganism.
Ruf teaches an open-pore foam-glass granular material is suitable for immobilizing microorganisms used in aerobic waste-water treatment (processing a microorganism for delivery to a site of use) (col.5 line 2-5 & 14-16). Ruf teaches a support (a substrate) that is constructed from a solid foam and on which an active component is immobilized (col.7 line 9-11). The support is constructed from a solid foam with a continuous phase which surrounds pores of the solid foam (col.9 line 63-64), the support can have a closed-pore foam structure over the whole of its volume, or a closed-pore structure only in its core or only in one part of its volume (p.16 line 56-61), and the continuous phase is provided by a glass, a silicate glass, a recycled glass (col.23 para 4). The active component includes several species of microorganisms, the microorganisms can be used as cultures or a complex biocoenoses (col.8 para 2, col.9 para 2). At least sections of the support preferably have an irregularly shaped surface, this makes it easier for microorganisms to grow on the surface of the support, the irregular surface can be produced by carefully grinding the support after foaming, with the result that the foamed support is broken, broken-open pores are then obtained at the broken surfaces (such that passageways extend from a first external surface to an interior and to a second external surface) (col.24 line 15-22). The microorganisms actively attach themselves to the surface of the support (col.9 line 15-16), the microorganisms can firstly form colonies on the surface of the support which can combine, upon further growth, to a biofilm, in a particularly preferred embodiment the microorganisms are in the form of a biofilm (comprising the microorganism embedded in a microbially produced matrix of extracellular polymeric substances, see para 0037 of the instant specification) immobilized on the support, and the biofilm particularly preferably includes several species of microorganism (a microbial consortium) (col.9 line 17-20, col.19 line 50-51, col.25 line 60-62). During a start-up phase of fermentation, the microorganisms multiply (col.14 line 26), and the microorganisms have a generation time of more than 24 hours (col.19 line 18-19). The support is coated with a nutrient solution, trace elements or also compounds which facilitate a growth of microorganisms on the support (a culture) (col.8 line 67, col.12 line 20-23). At least in the core of the support the solid foam has a closed-pore structure, the closed pores lend buoyancy to the support when introduced into a liquid (col.15 line 56-60), and the density of the support can be set (col.16 line 39-41), which implies that buoyancy is modified when the solid foam support is introduced into a liquid, since buoyancy is modified by changing the density relative to the surrounding fluid. The open-pore glass granular material is suitable for immobilizing microorganisms (col.5 line 2-3).
Ruf does not teach lyophilizing the adhered microorganism (claim 10), wherein the solid, porous substrate and the adhered lyophilized microorganism are configured to be stored and/or transported at standard temperature and pressure conditions (claim 13), transporting the solid, porous substrate and the adhered lyophilized microorganism to a site and growing and developing the lyophilized microorganism at the site (claims 23-24), and the site comprises a contaminated soil (claim 26) and a contaminated water (claim 27).
However, Ruf does teach microbial immobilization, wherein microorganisms are used as biocatalysts, and a nutrient solution, trace elements or compounds which facilitate a growth of microorganisms on the support are incorporate (col.8 line 67, col.12 line 20-23). Escobar teaches lyophilization is a long-term conservation method that guarantees the genetic stability and viability of the organisms preserved for periods of 10 or more years, also prevents the occurrence of successive generations, and lyophilized microorganisms are later stored in cold storage or room temperature (p.623 col left – para 4). In addition, Dzionek teaches immobilization of microorganisms capable of degrading specific contaminants significantly promotes bioremediation processes, reduces their costs, and also allows for the multiple use of biocatalysts (Abstract). Bioremediation is a commonly used method to restore the natural and useful values of contaminated sites by microorganism able to degrade, transform, or chelate various toxic compounds (p.29 col left – para 6). Soil bioremediation can be carried out at the place of contamination (p.29 col left – para 7), microorganisms introduced into the polluted environment (a site) as immobilized inoculum should be able to degrade specific contamination and survive in a foreign and unfriendly habitat (p.29 col right – para 2). The polluted environment also comprises a contaminated water (Abstract, p.29 col right – para 5).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to store and transport adhered lyophilized microorganisms at standard temperature and pressure conditions, since it was well-known in the art that lyophilization guarantees the genetic stability and viability of the microorganisms, and lyophilized microorganisms are stored at standard temperature and pressure conditions, as evidenced by Escobar. In addition, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to grow and develop the lyophilized microorganisms at a site, since Ruf discloses immobilization of microorganisms, Dzionek discloses that immobilized microorganisms are introduced into a contamination site and immobilization of microorganisms are capable of degrading specific contaminants, and Escobar discloses that lyophilization guarantees the genetic stability and viability of the microorganisms. In other words, one skill in the art would regrow and develop lyophilized microorganisms following deploying the immobilized microorganisms at the contamination site to degrade specific contaminants that significantly promotes bioremediation processes. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited references to store and/or transport a solid, porous substrate and adhered lyophilized microorganisms to a site, and to grow and develop the lyophilized microorganisms at the site, with a reasonable expectation of success.
References cited above do not teach the support (substrate) is in the form of an aggregate comprising a plurality of individual porous pieces having the claimed cross-sectional size (claim 35).
However, Ruf does teach the support wherein an aggregate is formed (col.12 line 19, col.14 line 30-31), the size of the pores can in principle be chosen as desired (col.16 line 51).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to form an aggregate comprises a plurality of individual porous pieces having a desired cross-sectional size, since Ruf discloses a support wherein an aggregate is formed and pore size can be optimized. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference and routine practice to form an aggregate comprises a plurality of individual porous pieces having a desired cross-sectional size, with a reasonable expectation for successfully obtaining a support.
Claims 30 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Ruf et al (US 8,637,300 B2; 1/28/2014.) in view of Escobar et al (J Microbiol Biotech Food Sci. 2021;10(4):620-625.) and Dzionek et al (Electronic Journal of Biotechnology. 2016;23:28-36.) as applied to claims 10, 12-13, 23-29, and 35 above, further in view of Gómez-Tena et al (Conference: XII FORO GLOBAL DEL RECUBRIMIENTO CERÁMICO. QUALICER 2014.).
References cited above do not teach the claimed average pore size as well as the claimed BET surface area (claims 30 and 34).
However, Ruf does teach the support (the substrate) comprises glass materials, wherein the size of the pores can in principle be chosen as desired (p.16 line 51). Gómez-Tena teaches different materials have different BET surface area, whereas glass spheres have BET surface area of 0.07 m2/g (Table 2), particle size and microstructure of the materials influence BET surface area (p.2 para 3).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to obtain a support (substrate) having a desired average pore size and BET surface area, since Ruf discloses culturing a microorganism in the presence of a solid, porous substrate comprises a glass-based material, wherein the size of the pores can in principle be chosen as desired, and Gómez-Tena discloses that particle size and microstructure of materials influence BET surface area. Therefore, one skill in the art would incorporate a support (substrate) having a desired average pore size and BET surface area for microbial immobilization. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference and routine practice to obtain a support (substrate) having a desired average pore size and BET surface area with a reasonable expectation of success.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Ruf et al (US 8,637,300 B2; 1/28/2014.) in view of Escobar et al (J Microbiol Biotech Food Sci. 2021;10(4):620-625.) and Dzionek et al (Electronic Journal of Biotechnology. 2016;23:28-36.) as applied to claims 10, 12-13, 23-29, and 35 above, further in view of Hust et al (US 2022/0145228 A1; 5/12/2022.).
References cited above do not teach the support (substrate) comprises vitreous components contained at least partially within the pores of the substrate (claim 31).
However, Ruf does teach the support is constructed from a solid foam with a continuous phase which surrounds pores of the solid foam. Hust teaches a support comprises vitreous materials (para 0013), wherein the support has closed cell structures and/or open cell structures (para 0020), and the vitreous materials may increase the structural integrity of a foamed mass, and the foamed mass may exhibit desired bulk densities and absorption capacities (para 0015).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to incorporate vitreous components, since Ruf and Hust both disclose a support, and Hust discloses that vitreous materials may increase the structural integrity of a foamed mass, and the foamed mass may exhibit desired bulk densities and absorption capacities. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference and routine practice to incorporate vitreous components with a reasonable expectation for successfully obtaining a support.
Response to Arguments
Applicant argues that Ruf does not lyophilize the microorganism-bearing support or otherwise preserve the adhered biofilm for storage and subsequent delivery to a site of use, that Hust does not disclose culturing a microorganism on the glass surfaces for at least 24 hours to form the claimed adhered biofilm, that Hust does not disclose lyophilizing the adhered microorganism, that replacing the closed-pore core of the magnetizable support of Ruf with the open-celled structure of Hust would alter the properties that Ruf identifies as advantageous for buoyancy, mechanical stability, and magnetic separation, that Ruf does not associate generation time with preparation of a supported biofilm for lyophilization, nor does Ruf recognize the culturing period preceding lyophilization as a parameter affecting post-lyophilization regrowth.
These arguments are not found persuasive because Escobar is relied upon to demonstrate lyophilizing the adhered microorganism. Furthermore, Ruf does teach culturing a microorganism on the glass surfaces for at least 24 hours to form the claimed adhered biofilm. In addition, Ruf’s support is not entirely closed-pore, and Hust is relied upon to demonstrate vitreous components. Finally, applicant’s arguments regarding culturing period and post-lyophilization regrowth appear to have no connection to the subject at issue, since rejected claims do not recite limitations regarding post-lyophilization regrowth.
Applicant argues that Escobar does not disclose lyophilizing a microorganism while the microorganism remains adhered as a biofilm to glass surfaces of an open-celled foamed glass ceramic.
These arguments are not found persuasive because Ruf does teach immobilization of microorganisms wherein microorganisms are attached as a biofilm to the surface of the support that is constructed from a solid foam with a continuous phase which surrounds pores of the solid foam, and the continuous phase is provided by a glass, a silicate glass, a recycled glass. Dzionek does teach immobilization of microorganisms capable of degrading specific contaminants significantly promotes bioremediation processes, microorganisms introduced into the polluted environment as immobilized inoculum should be able to degrade specific contamination and survive in a foreign and unfriendly habitat. Escobar does teach lyophilization is a long-term conservation method that guarantees the genetic stability and viability of the organisms preserved for periods of 10 or more years. Therefore, one skill in the art would lyophilize microorganism remains attached as a biofilm to glass surfaces of an open-celled foamed glass ceramic to ensure microorganism stability and viability.
Conclusion
No claims are 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 extension fee 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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN Y FAN whose telephone number is (571)270-3541. The examiner can normally be reached on M-F 7am-4pm.
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/Lynn Y Fan/
Primary Examiner, Art Unit 1759
