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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 April 23, 2026 has been entered.
Claims 2 and 14-22 have been canceled, Claims 32-33 have been added. Claims 1, 3-13 and 23-33 are pending, Claims 1 and 3-9 have been withdrawn, and Claims 10-13 and 23-33 have been considered on the merits. All arguments have been fully considered.
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 10-13, 23-29 and 31-33 are rejected 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.).
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, wherein upon the culturing, the microorganism is adhered to the substrate; and lyophilizing the adhered microorganism.
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). Support materials suitable for immobilization include natural and synthetic carriers represented by porous glass, silica-based materials, and ceramics (p.31 col right – para 2), and the main feature of the carriers is mechanical resistance, which allows to the recovery, regeneration and reuse of biocatalyst in bioremediation processes (p.33 col right – para 5).
Dzionek does not explicitly teach culturing the microorganism in the presence of a solid, porous substrate comprising a glass-based material (claim 10), and modifying the buoyancy of the solid, porous substrate (claims 28-29), wherein the substrate comprises citreous components contained at least partially within the pores of the substrate (claim 31), the microorganism is present in a microbial consortium of sessile microorganisms that have established a three-dimensional community including a combination of prokaryotic or eukaryotic cells embedded in a microbially produced matrix of extracellular polymeric substances (claim 32), and the microorganism is incubated for 24 hours or more after the step of culturing the microorganism and prior to the step of lyophilizing the adhered microorganism (claim 33).
However, Dzionek does teach porous glass seem to be promising materials for immobilization (p.34 col left – para 3), application of immobilized cell systems in bioremediation indicates several advantages over the usage of free microorganisms: prolonged activity, stability of biocatalyst, feasibility of continuous processing, increased tolerance to high toxic compounds concentration, easier recovery, possibility of regeneration and reuse of biocatalyst, reduction of microbial contamination risk and ability to use smaller bioreactors with simplified process, because each support has its own requirements in terms of the microorganisms used and the degraded compounds, the support selection is a key step which influences the success of bioremediation process (p.33 col right – para 4). 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). 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 (a microbial consortium of sessile microorganisms that have established a three-dimensional community including a combination of prokaryotic or eukaryotic cells 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 consortia) (col.9 line 18-20, col.19 line 50-51, col.25 line 60-62). 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. 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 open-pore glass granular material is suitable for immobilizing microorganisms (col.5 line 2-3). 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). In addition, Hust teaches a support comprises vitreous materials (para 0013), wherein the support has closed cell structures and/or open cell structures (such that passageways extend from a first external surface to an interior and to a second external surface) (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 culture a microorganism in the presence of a solid, porous substrate comprising a glass-based material, since Dzionek and Ruf both disclose microbial immobilization, and Ruf specifically discloses culturing a microorganism in the presence of a solid, porous substrate comprises a glass-based material. Therefore, a skill in the art would incorporate a solid, porous substrate comprises a glass-based material to immobilize microorganisms. 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 culture a microorganism in the presence of a solid, porous substrate comprising a glass-based material with a reasonable expectation of success.
References cited above do not teach lyophilizing the adhered microorganism (claim 10), wherein the solid, porous substrate and the adhered lyophilized microorganism are stored and 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).
However, Dzionek does teach soil bioremediation can be carried out at the place of contamination (p.29 col left – para 7), and microorganisms are introduced into the polluted environment as immobilized inoculum (p.29 col right – para 2), which implies that immobilized microorganisms are stored and transported to the contamination site. Dzionek does teach the main feature of the immobilization support allows the recovery, regeneration and reuse of biocatalyst in bioremediation process, 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).
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 microorganism at standard temperature and pressure conditions, since it was well-known in the art that lyophilization guarantees the genetic stability and viability of the organisms, 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 microorganism at a site, since Dzionek does teach immobilized microorganisms are introduced into a contamination site and immobilization of microorganisms are capable of degrading specific contaminants, Ruf discloses that nutrient facilitates a growth of microorganisms, and Escobar discloses that lyophilization guarantees the genetic stability and viability of the microorganisms. In other words, a 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 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.
Claim 30 is rejected 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.) as applied to claims 10-13, 23-29 and 31-33 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 and the claimed BET surface area (claim 30).
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 incorporate a support / substrate having a desired average pore size and BET surface area, since Dzionek and Ruf both disclose microbial immobilization, Dzionek discloses porous glass seem to be promising materials for immobilization, Ruf specifically discloses culturing a microorganism in the presence of a solid, porous substrate comprises a glass-based material where the size of the pores can in principle be chosen as desired, and Gómez-Tena discloses that glass spheres have the claimed BET surface area, and particle size and microstructure of the materials influence BET surface area. Therefore, a skill in the art would incorporate a support / substrate having a desired average pore size and BET surface area to immobilize microorganisms. 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 a support / substrate having a desired average pore size and BET surface area with a reasonable expectation of success.
Response to Arguments
Applicant argues that Dzionek, on page 31, paragraph 2 states that “[a] significant disadvantage of these carriers [i.e., porous glass] is the presence of a small number of functional groups, which prevents sufficient bonding of the biocatalyst. For that reason they are used in the formation of hybrid carriers, combining natural polymers and synthetic nanoparticles.” Therefore, a person having ordinary skill in the art, in view of Dzionek, would not believe that a porous glass would be a suitable substrate for microorganisms to adhere to because the porous glass “prevents sufficient bonding of the biocatalyst”, and instead directs a person having ordinary skill in the art to hybrid carrier systems incorporating natural polymers. In addition, a person having ordinary skill in the art, in view of Ruf, would not modify Ruf to have an open-celled porosity such that passageways extend from a first external surface to an interior and to a second external surface.
These arguments are not found persuasive because Dzionek does teach inorganic carriers have a high chemical, physical and biological resistance, and can be used in combination with natural polymers and synthetic nanoparticles (p.31 col right – para 2). Ruf does teach the support can be combined with natural polymers (col.11 line 40-55) and nanoparticles (col.17 line 46-47). In addition, Ruf does teach that an open-pore glass granular material is suitable for immobilizing microorganisms (col.5 line 2-3), that 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 that 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 (col.24 line 15-22).
Applicant argues that Dzionek discloses over 30 different carriers, and explicitly states that the porous glass "prevents sufficient bonding of the biocatalyst". Further, Table 1 of Gomez-Tina refers only to the surface areas of reference materials (i.e., silica, alumina, and titania) from a particular study, and page 2, paragraph 3 merely notes that surface area can affect particle size. A person having ordinary skill in the art, in view of these references, would have no motivation to select a glass from the numerous carriers disclosed in Dzionek, or a substrate having an average pore size of from about 100 micrometers to about 500 micrometers and a BET surface area of 5 m²/g or less.
These arguments are not found persuasive because Ruf is relied upon to demonstrate the substrate. Ruf does teach the substrate comprises glass materials having pores, and Gómez-Tena does teach that different materials have different BET surface area, whereas glass spheres have BET surface area of 0.07 m2/g, and that particle size and microstructure of the materials influence BET surface area. Before the effective filing date of the claimed invention, a skill in the art would have been motivated by the cited references and routine practice to optimize the pore size as well as the BET surface area of a selected substrate material to achieve desired outcomes.
Applicant argues that the cited references are silent as to the microorganism is present in a microbial consortium of sessile microorganisms that have established a three-dimensional community including a combination of prokaryotic or eukaryotic cells embedded in a microbially produced matrix of extracellular polymeric substances, and the microorganism is incubated for 24 hours or more after the step of culturing the microorganism and prior to the step of lyophilizing the adhered microorganism. However, these arguments are moot in light of the new rejections above and in view of applicant’s amendments.
Conclusion
No claims are allowed.
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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
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