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 .
Remarks
The amendments and remarks filed on 05/16/2025 have been entered and considered. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior office action. The rejections and/or objections presented herein are the only rejections and/or objections currently outstanding. Any previously presented objections or rejections that are not presented in this Office Action are withdrawn. Claims 1-20 are pending; Claims 1-8 and 10-20 are amended; Claims 14-20 are withdrawn; and Claims 1-13 are under examination.
Priority
This application, U.S. Application number 18/503854, was filed as a DIV of U.S. Application number 16/689978, filed on 11/20/2019 and now issued as U.S. Patent No. 11845927, which claims benefit under 35 U.S.C. 119(e) to U.S. provisional application No. 62/770,554 filed on 11/21/2018.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/16/2025 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97 and has been considered by the examiner.
Withdrawal of Objection
The objection to the drawings (Figures 53 and 54) is withdrawn due to the replacement of the drawings submitted on 05/16/2025.
Withdrawal of Rejections
The rejection of claims 1-13 under 35 U.S.C. 112(b) in the previous office action is withdrawn due to the amendment to the claims.
The rejections of claims 1-13 on the ground of nonstatutory obvious-type double patenting over claims of U.S. Patent No. 11845927 in view of Semprini et al., Kuntz et al., Emblem, Dai et al., and/or Gao et al. are withdrawn due to the granting of DIV status to the instant application, as indicated in Examiner’s interview summary dated 02/20/2025 and Applicant’s response filed on 05/16/2025 (pages 7 and 13).
Claim Rejections - 35 USC § 112(b), or 112, Second Paragraph
Claim 12 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 12 is indefinite due to the recitation of “the orthosilicate induces production of an enzyme by the bacterium species …”. It is noted that the recited “bacterium species” is not a bacterium, rather it stands for classification of bacteria, wherein a specific bacterium is classified as belonging to a specific bacterial species. Further, an enzyme can only be produced by bacterial cells. It is unclear how the claimed enzyme can be produced by a non-physical bacterium species. For the purpose of examination, the recited phrase is interpreted as “the orthosilicate induces production of an enzyme by the one or more microbial cells …” to be consistent with the base claim 1.
Claim Rejections - 35 USC § 103
Claims 1-4 and 8-13 are rejected under 35 U.S.C. 103 as being unpatentable over Semprini et al. (US 6472198, 2002; cited in the IDS) in view of Dai et al. (CN 105087540 A, 2015, cited in IDS, English translated version of record in parent application No. 16/689978) and Razavi-Shirazi et al. (Water Environmental Res., 2000, 72(4): 460-468, cited in IDS, of record in the parent application). This rejection is maintained.
This is a rejection of the GENERIC claims with respect to the specie of microbial cells in the presence of an orthosilicate.
Semprini teaches a composition and a method of using the composition for bioremediation of contaminates, the composition comprising a microorganism and at least one slow release compound having at least one hydrolysable organic acid capable of forming an organic acid or an alcohol upon hydrolysis, wherein the organic acid and alcohol generated from the hydrolysis are used by the microorganism as nutrient/energy supply for degrading contaminates; wherein the hydrolysis occurs over an extended period of time (abstract, col. 3/para 2, col 5/lines 5-15, the para spanning col. 3 and col 4); wherein the at least one slow release compound is a organometallic or organosilicon compound preferred to be an alkoxysilane having a formula Si(OR)4 (para spanning cols. 7 and 8, col. 8/lines 7-21), which is exampled as: TKEBS, i.e. tetrakis(2-ethylbutoxysilane) or tetra-2-ethylbutanol orthosilicate (col. 9/lines 1-7 and 31-55, Claim 33, Table 1/the entry of compound “3”) (Note: this compound reads on the orthosilicate of formula 1 recited in Claims 1-3) as well as tetrakis(1-methylethoxy) silane, i.e. tetraisopropoxysilane, that releases iso-propanol/2-propanol as a hydrolysis product (see the entry of compound “18”, last 2 lines of Table 1) (Note: this compound reads on the orthosilicate of formula 1 recited in Claims 1-3 and also tetraisopropoxysilane (T2POS) recited in Claim 4); wherein the at least one slow release compound can be encapsulated (col 11/lines 2-4); wherein the microorganism and slow release compound in the composition degrade environmental contaminants, including those in soil, sediment, sludge, water, or combination thereof, such as chlorinated hydrocarbons in subsurface water, e.g., ground water (col. 3/lines 53-61, col. 4/lines 55-68, col 12 - col 22/Examples); and the bioremediation treatment can be in situ or ex situ where the microorganism can be added to a contaminated sample (col 3/lines 59-61, col. 4/lines 55-68); and wherein the microorganism is anerobic or aerobic, and is a bacterium such as a methanogen, acetogen, dehalogenating bacterium (col 3/lines 50-52, col. 6/lines 39-55), which induces or produces enzymes such as monooxygenases, dioxygenases, hydrolases or mixtures thereof, and exampled monooxygenases include methane monooxygenases, propane monooxygenases, butane monooxygenases, and mixtures thereof (col. 6/lines 46-52) (Note: these enzymes read on the SCAM monooxygenases recited in Claim 12). Semprini also teaches that the environmental contaminants include halogenated organic compounds, wherein the halogenated organic compounds have saturated aliphatic groups, and contaminants can be chlorinated ethene or ethane, including trichloroethene (TCE), vinyl chloride (VC), cis-dichloroethene (cis-DCE), tetrachloroethene (col. 3/lines 41-43, col 1/lines 10-35, col 5/last para, col. 6/lines 1-4 and 9-20) (Note: these read on or render obvious the chlorinated ethene recited in the instant claims 10 and/or 11). Semprini further teaches, in Examples 1-5, that activated aerobic sludge and microbial culture after being enriched effectively degrade contaminants (including TCE, DCE) with orthosilicate TKEBS or TBOS.
Semprini does not teach that the bacterium along with the orthosilicate is encapsulated with an encapsulating material (e.g. alginate, recited in instant claim 8) in macrobeads having one dimension of at least 1 mm or greater (recited in instant claim 9), where a column is packed with encapsulated bacterium along with the orthosilicate (recited in instant claim 13).
Dai et al. teach a composition (microorganism embedding and repairing agent) for degrading petroleum pollutant and bioremediating estuary, seaport, sandy beach and wetland, comprising porous particles (i.e. beads), where the porous particles comprise microorganisms, nutrients for the microorganism, and cross-linked alginate gel (embedded skeleton), wherein the microorganisms and nutrients are internally embedded/encapsulated in the cross-linked alginate gel/embedded skeleton; wherein the particle has a particle size of 2-6 mm; wherein the particle has porosity 70-96%; and wherein the microorganism is a bacterium in the genus of Rhodococcus or Brevibacterium (see abstract, pages 1-2). Dai et al. also teach that the embedded/encapsulated microorganism is protected from external environment, can survive for a long term of time period, and it is safe and well tolerant for external environment, effective for degrading petroleum pollutant, thus having broad applications for bioremediation; and that during preparation of particles, the sizes of the particle diameter can be effectively controlled for obtaining microorganism-embedded particles with uniform particle diameter (page 3/paras 1-3, page 5/last para – page 6/para 4). Dai et al. further teach that process of preparing the microorganism-embedding particle/bead in their invention is simple and easy, and the prepared agent is suitable for large-scale production and environmental protection field; and particles have highly developed pore system and low mass transfer resistance in the particles, thus allowing effective diffusion of microbial metabolic products from the encapsulated microorganism and crude oil pollutants to the encapsulated microorganism (page 2/para 2, page 3/paras 1-2, page 6/paras 2 and 4).
Razavi-Shirazi teaches the removal of 2,4,6-trichlorophenol (TCP) from groundwater using PVA-immobilized cells using column studies under various operating conditions to stimulate a biological trench permeable barrier. It was found that the PVA- immobilized cells completely dehalogenated TCP (abstract). The diameter of the immobilized cells were 3 to 5 mm in the column studies (page 461, right column, second full paragraph). Razavi-Shirazi further teaches that the entrapped microorganisms are protected against toxic chemicals compared to free cells (page 460/last para/lines 2-4 from bottom).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to encapsulate the bacterium and the orthosilicate of Semprini in an alginate particle/macrobead having at least one dimension of at least 1 mm for preparing a bioremediation composition to be used in the method of Semprini for degrading environmental contaminants, as taught by Dai et al. and Razavi-Shirazi. The ordinary artisan would have been motivated to do so because Semprini expressively teaches encapsulating the slow release orthosilicate, which acts as a nutrient/energy source to the microorganism/bacterium after hydrolyzation, and that a combination of the bacterium and orthosilicate is required for effectively environmental contaminants. In addition, it had been well known in the art that encapsulated microorganisms have the advantages of being protected against toxic chemicals, a long term of survival, and being well tolerant for external environment, compared to free cells, as supported by Dai et al. and Razavi-Shirazi. Furthermore, it had been well known in the art to co-encapsulate both microorganisms and their nutrients in the same particles/beads for effectively degrading contaminates and bioremediating environment, as supported by Dai et al. Moreover, it had been demonstrated in the art that macro beads (alginate macrobeads) having at least one dimension of at least 1 mm have a low mass transfer resistance and are efficient for removing pollutants in external environments, such as water, subsurface water, sediments, wetland, and soil, as supported by Dai et al. and Razavi-Shirazi. These applications are applicable to the purposes of Semprini which is the decontamination of water, subsurface water (e.g., ground water), sediments, sludge or soil. The ordinary artisan would have had a reasonable expectation at modifying the composition of Semprini by adopting the teachings of Dai et al. and Razavi-Shirazi for obtaining an alginate macrobead that encapsulates the bacterium/microorganism and an orthosilicate co-substrate for bioremediating purposes, because both the cited prior art and Semprini are directed to using microorganisms for degrading contaminants and bioremediating environments. The ordinary artisan would have had a reasonable expectation for preparing an alginate microbead with a dimension of at least 1 mm containing an orthosilicate and a microbial cell, because Dai et al. teach the process of preparing alginate beads containing microbial cells and their nutrients is simple and easy, and the size of the beads can be effectively controlled for obtaining macrobeads having uniform diameters/sizes.
Regarding Claim 13, Semprini does not teach a column is packed with the composition of the bacterium . However, it would have been obvious to pack a column with the macrobeads suggested by Semprini, Dai et al., and Razavi-Shirazi for degrading contaminates and bioremediating environment, because it had been well known in the art that macrobeads are suitable for column decontamination, as supported by Razavi-Shirazi. The column decontamination would be well suitable to the purposes of Semprini, given Semprini teaches the bioremediation treatment can be in situ or ex situ.
Regarding Claim 10, Semprini and Dai et al. teach applying a combination of microorganisms and their nutrients/orthosilicate to a contamination site or a sample having contaminants of concern; and Dai et al. further teach the contaminants can be diffused into the beads containing the microorganisms and their nutrients. Thus, it would have been obvious for the composition containing the encapsulated microbial cells and the orthosilicate, suggested by Semprini, Dai et al., and Razavi-Shirazi, to further comprises a contaminant of concern, such that the encapsulated microbial cells can act on and degrade the contaminant.
Regarding Claim 12, the further limitation recited in the claim is directed to what the orthosilicate does to the bacterium. Semprini teaches the bacterium induces and produces SCAM alkane monooxygenases, and the slow release orthosilicate acts as a nutrient/energy source to the bacterium. Given the orthosilicate promotes growth of bacterial cells, more SCAM enzymes would be induced from growing bacterial cells in the presence of orthosilicate.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention.
Claims 1-5 and 8-13 are rejected under 35 U.S.C. 103 as being unpatentable over Semprini et al. (US 6472198, 2002; cited in the IDS) in view of Dai et al. (CN 105087540 A, 2015, cited in the IDS, English translated version of record in parent application No. 16/689978) and Razavi-Shirazi et al. (Water Environmental Res., 2000, 72(4): 460-468, cited in the IDS, of record in the parent application), as applied to Claims 1-4 and 8-13, further in view of Gao et al. (CN 100427594C, 2008, cited in IDS, English translated version of record in parent application). This rejection is maintained.
The disclosure of Semprini as modified by Dai et al. and Razavi-Shirazi et al. is discussed supra.
Regarding Claim 5, the modified Semprini does not teach that orthosilicate (the slow-release compound) is co-encapsulated with the microbial cells at a high mass loading 5% (w/w) or greater.
Gao teaches a silica gel particle (an orthosilicate) encapsulated with an enzyme or microbial cells where the diameter of the gel particle is from 2 to 5 mm (abstract). Microbial cells can be photosynthetic bacteria that are active for sewage treatment (page 3, second paragraph). In Example 2, 13 ml (12.2 g; see Example 1 for the equivalence) was combined with 1.26 ml of distilled water (1.26 g) and 0.09 ml of acetic acid (0.094 g) until a sol was formed. 0.2 g of photosynthetic bacteria were dissolved in 5 ml of Tris buffer (5.0 g) until particles were formed. Thus, the amount of the orthosilicate and bacteria (12.4 g) compared to the total of all of the components (18.754 g) is 12.4/18.754) 0.66 or 66% (w/w) which is greater than 5% (w/w). The particles removed phenol from water samples.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to co-encapsulate the slow release orthosilicate and microbial cells of modified Semprini at a loading mass of 5% or greater. The ordinary artisan would have been motivated to do so and had a reasonable expectation of results because Gao teaches the employment of an orthosilicate/microbial cell particle with a mass loading of 66% which is effective for the decontamination of phenol from water samples.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention.
Claims 1-4 and 6-13 are rejected under 35 U.S.C. 103 as being unpatentable over Semprini et al. (US 6472198, 2002; cited in the IDS) in view of Dai et al. (CN 105087540 A, 2015, cited in IDS, English translated version of record in parent application No. 16/689978) and Razavi-Shirazi et al. (Water Environmental Res., 2000, 72(4): 460-468, cited in IDS, of record in parent application), as applied to Claims 1-4 and 8-13, further in view of Kuntz et al. (J. Ind. Microbial. Biotechnol., 2002, 30: 651-655, cited in IDS, of record in parent application). This rejection is maintained.
The disclosure of Semprini as modified by Dai et al. and Razavi-Shirazi et al. is discussed supra.
Regarding Claims 6 and 7, Modified Semprini does not teach that the bacterium is R. rhodochrous ATCC 21198.
Kuntz et al. teach that vinyl chloride (VC) is a human carcinogen and listed as a priority pollutant (page 251, right column, lines 1-3), and that R. rhodochrous ATCC 21198 grown on isopropanol or acetone (as carbon source) induces vinyl chloride (VC) degradation via induction of enzymes, and the fact that isopropanol-grown cells suggests that an oxygenase is involved in their metabolism (abstract, table 1, page 652/right column first paragraph, page 653/the para spanning right and left columns).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add R. rhodochrous ATCC 21198 to a tetraisopropoxysilane (T2POS)-containing macrobead of modified Semprini for bioremediation of environmental contaminants. The ordinary artisan would have been motivated to do so, because modified Semprini teaches using tetraisopropoxysilane (T2POS) as a slow-release orthosilicate for providing a hydrolysis product of alcohols as a nutrient/energy source to bacteria/microorganisms for their bioremediating contaminates including vinyl chloride (VC), wherein the hydrolysis product of T2POS is 2-propanol (i.e. iso-propanol). Furthermore, it is well known in the art that R. rhodochrous ATCC 21198 grown on isopropanol as a nutrient/energy source induces vinyl chloride degradation, as supported by Kuntz et al. The ordinary artisan would have a reasonable expectation of success at applying the teachings of Kuntz et al. to modified Semprini et al. for arriving at the claimed composition, because both the composition/method of Kuntz et al. and the composition/method of modified Semprini et al. are directed to bioremediation of environmental contaminants including vinyl chloride (VC) by using bacteria.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention.
Double Patenting
Claims 1-4 and 8-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-51 of U.S. Patent No. 6472198 in view of Dai et al. (CN 105087540 A, 2015, cited in the IDS, English translated version of record in the parent application No. 16689978) and Razavi-Shirazi et al. (Water Environmental Res., 2000, 72(4): 460-468, cited in IDS, of record in parent application). This rejection is maintained.
The claims 44-45 and 48-51 of the ‘198 patent are drawn in part to a kit for bioremediation of environmental contaminant in a sample containing microorganisms, comprising at least one slow release compounds having at least one hydrolysable organic group in an amount sufficient to from at least one alcohol, at least one organic acid or a combination thereof. The remaining claims of the ‘198 patent are drawn in part to a method for degrading one or more environmental contaminants (specifically halogenated organic compound) in a sample containing microorganisms, comprising: contacting a sample containing microorganisms and a contaminant with a liquid or solid form of at least one slow release compounds having at least one hydrolysable organic group in an amount sufficient to from at least one alcohol, at least one organic acid or a combination thereof for the microorganisms to degrade the environmental contaminant, wherein claims 10-11 and 32 of ‘198 define that the slow release compound is an organosilicate, such as tetrapropoxysilane, tetrakis(2-ethylbutoxy) silane, tetrakis(2-methylbutoxy) silane, tetrakis(1-methylpropoxy) silane, tetrakis(2-methylpropoxy) silane, tetrakis(1-methylethoxy) silane (i.e. tetraisopropoxysilane or T2POS), and tetrakis(1-hydroxypropoxy) silane (meeting the instant formula I and reading on those recited in claim 1 and/or claims 2-4); wherein the claims 5-6 and 31-32 of ‘198 define that the contaminant(s) is/are halogenated organic compound(s) or chlorinated hydrocarbon(s), such as cis-dichlorocthene, vinyl chloride, trichloroethene, tetrachloroethene, or trichlorofluoroethylene, as in instant claims 10-11; wherein the claims 16-20 of ‘198 define the microorganisms as dehalogenating bacteria or bacteria that produce or induced enzymes selected from monooxygenases, dioxygenases, hydrolases and mixtures thereof, and the monooxygenases are methane monooxygenases, propane monooxygenases, butane monooxygenases, or mixtures thereof (reading on the enzymes recited in instant claim 12); wherein the claims 23-25 and 35-37 of ‘198 define that the bioremediation is carried out in situ or ex situ and the sample is an environmental one that contains sludge, soil or sediment that can be groundwater. Overall, the claims of the ‘198 patent specify compositions and methods of using the compositions having the instantly claimed limitations, including the bacterial microorganisms, co-metabolism orthosilicate substrate, and contaminants.
The claims of ‘198 do not teach that the bacterium along with the orthosilicate is encapsulated with an encapsulating material (e.g. alginate, recited in instant claim 8) in macro beads having one dimension of at least 1 mm or greater (recited in instant claim 9), where a column is packed with encapsulated bacterium along with the orthosilicate (recited in instant claim 13).
The teachings of Dai and Razavi-Shirazi are discussed supra.
It would have been obvious to one of ordinary skill in the art to encapsulate the bacterium and the slow-release orthosilicate of the claims of ‘198 in an alginate particle/macro bead having at least one dimension of at least 1 mm for preparing a bioremediation composition for degrading environmental contaminants, as taught by Dai et al. and Razavi-Shirazi. The ordinary artisan would have been motivated to do so because the claims of ‘198 teach the slow release orthosilicate after hydrolyzation supports the microorganism/bacterium to degrade environmental contaminants. In addition, it had been well known in the art that encapsulated microorganisms have the advantages of being protected against toxic chemicals, a long term of survival, and being well tolerant for external environment, compared to free cells, as supported by Dai et al. and Razavi-Shirazi. Furthermore, it had been well known in the art to co-encapsulate both microorganisms and their nutrients in the same particles/macrobeads for effectively degrading contaminates and bioremediating environment, as supported by Dai et al. Moreover, it had been demonstrated in the art that macrobeads (alginate macrobeads) having at least one dimension of at least 1 mm have a low mass transfer resistance and are efficient for removing pollutants in external environments, such as water, subsurface water, sediments, wetland, and soil, as supported by Dai et al. and Razavi-Shirazi, and these applications are applicable to the purposes of decontamination of ‘198. The ordinary artisan would have had a reasonable expectation at modifying the composition suggested by the claims of ‘198 by adopting the teachings of Dai et al. and Razavi-Shirazi for preparing an alginate macrobead with a dimension of at least 1 mm which encapsulates the bacterium/microorganism and orthosilicate co-substrate for bioremediating purposes. This is because Dai et al. teach the process of preparing beads containing microbial cells and their nutrients is simple and easy, and the size of the beads can be effectively controlled for obtaining macrobeads having uniform diameters/sizes.
Regarding Claim 13, the claims of ‘198 do not teach a column is packed with the composition of the bacterium . However, it would have been obvious to pack a column with the macrobeads suggested by the claims of ‘198, Dai et al., and Razavi-Shirazi for degrading contaminates and bioremediating environment, because it had been well known in the art that macrobeads are suitable for column decontamination, as supported by Razavi-Shirazi. The column decontamination would be well suitable to the purposes of the claims of ‘198, because the claims of ‘198 teach the bioremediation treatment can be in situ or ex situ.
Regarding Claim 10, the claims of ‘198 and Dai et al. teach applying a combination of microorganisms and orthosilicate/nutrients to a contamination site or an orthosilicate/nutrients to a sample containing the microorganisms/bacteria and contaminants of concern; and Dai et al. further teach the contaminants can be diffused into the beads containing the microorganisms and their nutrients. Thus, it would have been obvious for the composition containing the encapsulated bacterial cells and the orthosilicate, suggested by the claims of ‘198, Dai et al., and Razavi-Shirazi, to further comprises a contaminant of concern, such that the encapsulated bacterial cells can act on and degrade the contaminant.
Therefore, in view of the teachings of the cited prior art, the composition of Claims 1-4 and 8-13 of the instant application is deemed obvious over the composition suggested by Claims 1-51 of U.S. Patent No. 6472198.
Claims 1-5 and 8-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-51 of U.S. Patent No. 6472198 in view of Dai et al. (CN 105087540 A, 2015, cited in the IDS, English translated version of record in the parent application No. 16689978) and Razavi-Shirazi et al. (Water Environmental Res., 2000, 72(4): 460-468, cited in IDS, of record in parent application), as applied to claims 1-4 and 8-13 above, in further view of Gao et al. (CN 100427594C, cited in IDS, English-translated version of record in parent application). This rejection is maintained.
The disclosure of the claims of ‘198 as modified by Dai and Razavi-Shirazi is discussed supra.
Regarding Claim 5, the modified ‘198 does not teach that the slow-release compound is co-encapsulated with the bacterial cells at a high loading 5% (w/w) or greater.
The teachings by Gao is discussed supra.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to co-encapsulate the slow release orthosilicate and bacterial cells of Modified ‘198 at a loading mass of 5% or greater. The ordinary artisan would have been motivated to do so and had a reasonable expectation of results because Gao teaches the employment of an orthosilicate/microbial cell particle with a mass loading of 66% which is effective for the decontamination of phenol from water samples.
Therefore, in view of the teachings of the cited prior art, the composition of Claims 1-5 and 8-13 of the instant application is deemed obvious over the composition suggested by Claims 1-51 of U.S. Patent No. 6472198.
Claims 1-4 and 6-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-51 of U.S. Patent No. 6472198 in view of Dai et al. (CN 105087540 A, 2015, cited in the IDS, English translated version of record in the parent application No. 16689978) and Razavi-Shirazi et al. (Water Environmental Res., 2000, 72(4): 460-468, cited in IDS, of record in parent application), as applied to claims 1-4 and 8-13 above, in further view of Kuntz et al. (J. Ind. Microbial. Biotechnol., 2002, 30: 651-655, cited in IDS, of record in parent application) and Emblem et al. (J. Appl. Chem. Biotechnol., 1971, 21: 317-318, cited in IDS, of record in parent application). This rejection is maintained.
The disclosure of the claims of ‘198 as modified by Dai and Razavi-Shirazi is discussed supra.
Regarding Claims 6 and 7, Modified ‘198 does not teach that the bacterium is R. rhodochrous ATCC 21198.
The disclosure by Kuntz are discussed supra.
Emblem teaches the preparation and hydrolysis of tetraisopropoxysilane (i.e. T2POS) (abstract). The compound is known to undergo slow hydrolysis in the absence of catalyst or undergo hydrolysis under acidic conditions, to release isopropanol (page 318, right column, last paragraph).
It would have been obvious to one of ordinary skill in the art to include R. rhodochrous ATCC 21198 to the tetraisopropoxysilane/T2POS-containing macrobead of Modified ‘198 as the microorganism for bioremediation of environmental contaminants. The ordinary artisan would have been motivated to do so, because the claims of Modified ‘198 teach using tetraisopropoxysilane (T2POS) as a slow-release orthosilicate for providing a hydrolysis product/alcohols to support bacteria/microorganisms for their bioremediating contaminates including vinyl chloride (VC). In addition, Emblem teaches that the hydrolysis product of T2POS is iso-propanol. Furthermore, it is well known in the art that R. rhodochrous ATCC 21198 grown on isopropanol as a nutrient/energy source induces degradation of contaminant vinyl chloride, as supported by Kuntz et al. The ordinary artisan would have a reasonable expectation of success at applying the teachings of Kuntz et al. to Modified ‘198 for arriving at the claimed composition, because both the teachings of Kuntz et al. and the teachings of Modified ‘198 are directed to bioremediation of environmental contaminants including vinyl chloride (VC) by using bacteria.
Therefore, in view of the teachings of the cited prior art, the composition of Claims 1-4 and 6-13 of the instant application is deemed obvious over the composition suggested by Claims 1-51 of U.S. Patent No. 6472198.
Response to Arguments
Applicant's arguments about the rejection of Claims 1-13 under 35 U.S.C. 112(b) in the response filed on 05/16/2025 (page 7) have been fully considered but they are moot, because the rejection has been withdrawn, as indicated above. However, the amended claim 12 submitted on 05/16/2025 raised new issue, and the claim is rejected under 35 U.S.C. 112(b) for the reason indicated above.
Applicant's arguments about the rejection of Claims 1-4, 6, and 8-13 under 35 U.S.C. 103 in the 05/16/2025 response (pages 7-11) have been considered but they are not persuasive for the following reasons.
As a first matter, the prior art reference Dai referred by Applicant in the 05/16/2025 response is an English-language description that is different from the machine-translated English version of record. However, Applicant did not attach this different English version of Dai to the response, and only provided an Espacenet link at the footer of page 8. Examiner has made effort to find this different English version by using the link provided, but without success. Without this English version, it is unclear which specific parts of Dai the paragraph numbers cited by Applicant are referred to. As such, Applicant’s arguments in page 8/para 2 of the response cannot be fully considered.
In pages 7-10 (cited with Exhibits A-D) of the 05/16/2025 response, Applicant asserted that pores in the beads of Dai are “super large”, although Dai expressively teaches the pore sizes of their beads are in a wide range starting from as low as 0.1 mm and up to 200 mm (see abstract); Applicant made assumption that Rhodococcus bacteria in the beads of Dai are under attach and eaten by protozoa through the “super large” pores; and then asserted there is no reasonable expectation of success for bacteria in Dai’s beads to drive bioremediation due to “super large” pores of the beads, and a POSITA would not be motivated to apply Dai to modify Semprini, although Example 6 of Dai clearly demonstrate the Rhodococcus bacteria encapsulated in beads having small pore sizes (i.e. 0.5 – 80 mm) are successful at removing oil contamination (see Example 6 in page 9 of fully English-translated version of Dai, attached to this action). These arguments about Dai et al. are not persuasive, because Applicant’s arguments about pore sizes of beads and protozoa are based on the features not recited in the claims. It is noted that the claims do not recite any limitations to limit pore sizes of the beads in the claimed composition or to define that the claimed composition comprises protozoa, and the claims do not require the claimed composition is capable of driving bioremediation in the presence of protozoa. Furthermore, 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). Given Dai et al. expressively teach the pore sizes of beads are in a range of 0.1 mm to 200 mm and specifically demonstrate that beads with pore sizes of 0.5 mm – 80 mm effectively degrade oil contaminants, a POSITA would not consider the beads of Dai require the “super large” pore sizes. Rather, a POSITA would consider small pore sizes are applicable to the beads of Dai. It would have been obvious to POSITA to apply the teachings of Dai to modify the method of Semprini by encapsulating bacteria and orthosilicate of Semprini in alginate beads for degrading environmental contaminants, with motivation along with a reasonable expectation of success for all the reasons indicated above.
With regard to Applicant’s arguments about cell viability of PVA-immobilized bacterial cells of Razavi-Shirazi et al. in the 05/16/2025 response (pages 10-11), they are not persuasive because they are based on the feature not recited in the claims. Examiner notes that the instant claims do not recite any limitations to define cell viability or require a specific number of viable bacterial cells encapsulated in beads. Rather, the claimed composition is open to comprise any number of bacterial cells (viable or dead) belonging to any bacterial species. In response to Applicant’s arguments based on Exhibit E in last para of page 10, it is noted that the two potential problems are disclosed in the “Introduction” section of Exhibit E for the purpose of reviewing previous studies, however, in the study of Exhibit E these two problems are effectively addressed and resolved. See: page 447/right col/para 3 “In this article, a new cell immobilization technique is described which eliminates the agglomeration problem of the PVA-boric acid method by the addition of a small amount of calcium alginate”; and page 448/last para “It was found that agglomeration of the beads was entirely prevented for PVA to alginate solution ratios of 5:1, 8:1, 10:1, and12.5:1”. Also see Exhibit E successfully applied the techniques for phenol-degrading Pseudomonas bacteria, i.e. “other types of cells” in page 449/last para “Immobilization of living cells of a phenol-degrading Pseudomonas isolate in a PVA-boric acid gel was demonstrated. Cell viability was indicated by degradation of phenol in a fluidized bed reactor of the beads … The successful immobilization of a Pseudomonas isolate by the PVA-boric acid method indicates that the technique might be applicable to a wide variety of microorganisms” (emphasis added). In response to Applicant’s continuous arguments in paras 1-2 of page 11, it is noted that the bacterial cells recited in the instant claim 1 can be any bacterium, not limited to a Rhodococcus bacterium or the strain of R. rhodochrous ATCC 21198. It is known in the art that Different types of bacteria cells after being PVA-immobilized maintain their cell viability and are capable of driving bioremediation of contaminates, as evidenced by Exhibit E and Razavi-Shirazi et al. As such, one of the ordinary skill in the art would have recognized that these types of PVA-immobilized bacterial cells can be readily applicable in the method of Semprini. With regard to Exhibit F, the paragraphs (page 13: col 1, 1st and last paragraphs) cited by Applicant are in the Discussion section of this publication, where the authors suspected the negative effect of boric acid on cell viability, which, however, are not supported by direct evidence. Examiner notes that the increased rate of oxygen consumption is a clear evidence that PVA-immobilized cells of R. rhodochrous ATCC 21198 are viable and not killed by boric acid during cross-linking process, indicating that viable R. rhodochrous cells are successfully PVA-immobilized. Indeed, the “Conclusions” section of Exhibit F (page 15) teaches that “We have demonstrated the capability of poly(vinyl)-alcohol –alginate beads for the immobilization of ATCC 21198 with a slow-release compound …these beads would provide cells with a stable, durable microenvironment and a constant carbon source. These beads have already been applied in long term column studies and could be applied as an in situ”. Overall, Exhibit F provides positive feedback for using PVA and alginate beads for immobilizing ATCC 21198 with a slow-release compound for bioremediation of contaminates, and the effect of boric acid on cell viability appears to be a minor issue. Furthermore, it would have been obvious to a POSITA to apply other encapsulation techniques for encapsulating bacterial cells in the method of Semprini for bioremediating contaminates, given these techniques are well established in the art, even assuming the bacterium in claim 1 is specifically limited to R. rhodochrous ATCC 21198 and boric acid has negative effect on this bacterium. For example, Dai et al. expressively teach a simple and easy process for encapsulating viable Rhodococcus cells in alginate beads for bioremediating contaminates, in which no boric acid is involved in the process. A POSITA would have recognized that this process is readily appliable for preparing beads encapsulated with bacterial cells and orthosilicate in the method of Semprini (as indicated above). Therefore, in view of the combined teachings of Semprini, Dai et al., and Razavi-Shirazi et al., the claims 1-4 and 8-13 would have been obvious for all the reasons indicated above.
In response to Applicant’s arguments about the rejection of Claims 1-6 and 8-13 under 35 U.S.C. 103 in the 05/16/2025 response (pages 11-12), it is noted that generally, differences in concentration or temperature will not support the patentability of subject matter unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456,105 USPQ 233, 235 (CCPA 1955). The combined teachings of Semprini, Dai et al., and Razavi-Shirazi et al. suggest a composition that meets all the limitations in the claim 1. It is considered that a mass loading of orthosilicate and microbial cells in beads is readily adjustable through optimization. The amount of 5% or higher recited in the claim 5 does not render the claim patentable or non-obvious, in the absence of evidence to support it is critical.
Applicant's arguments about the rejection of Claims 1-4 and 6-13 under 35 U.S.C. 103 in the 05/16/2025 response (page 12) have been fully considered. These arguments are the same as those previously presented arguments about Dai et al. and Razavi-Shirazi, and they are not persuasive for all the reasons indicated above.
Applicant's arguments about the rejections of Claims 1-13 on the ground of obvious-type double patenting over the claims of U.S. Patent No. 6472198 in view of Dai, Razavi-Shirazi, and/or Kuntz in the 05/16/2025 response (pages 12-13) have been fully considered. These arguments are the same as those previously presented arguments about Dai et al. and Razavi-Shirazi, and they are not persuasive for all the reasons indicated above.
Conclusion
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 date of this final action.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Qing Xu, Ph.D., whose telephone number is (571) 272-3076. The examiner can normally be reached on Monday-Friday from 9:30 AM to 5:00 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath N. Rao, can be reached at (571) 272-0939. Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to the receptionist whose telephone number is (571) 272-1600.
/Qing Xu/
Patent Examiner
Art Unit 1656
/MANJUNATH N RAO/Supervisory Patent Examiner, Art Unit 1656