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
Claims 38-44 as amended and new claims 61-72 as filed on 12/18/2025 are pending and under examination in the instant office action.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 38-44 as amended and new claims 61-72 remain/are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0151533 (Downey et al), US 9,932,543 (Hashman et al), US 10,610,552 (Everett et al) and US 10,653,729 (Boyette et al).
As applied to the current first independent claim 38:
US 2011/0151533 (Downey et al) teach a method for methane production wherein the method comprises:
step of feeding a feedstock to the digester; wherein the feedstock materials include food waste and agricultural waste (par. 0072, last 3 lines), plant and crop waste (par. 0003), thereby, “solid” food waste or solid “food manufacturing waste” within the meaning of the claims (claims 38, 62, 66, 70),
step of processing the feedstock with a bacterial consortium including hydrolytic, acidogenic, acetogenic and methanogenic bacteria (par. 0003, 0009, 0019, 0064, 0090) in order to produce gas including methane (0084), and
producing gas including up to 97% of methane (0084);
wherein the bacterial consortium comprises representatives of Bacillus (0090);
wherein microbial nutrients and stimulants are added as intended to facilitate microbial growth and biological function (0093, 0094);
wherein the digestion and/or digester are anaerobic as intended for methane production (0082).
Thus, the cited document US 2011/0151533 (Downey et al) teaches a substantially similar method for methane production from a feedstock by a mixed bacterial consortium in an anaerobic digester by major steps such as feeding feedstock, processing feedstock and producing methane. The cited document clearly teaches the use of a bacterial consortium comprising species of Bacillus (par. 0090)
Now as applied to the claimed steps of forming a “bioaugmentation solution” and dosing the anaerobic digested with the bioaugmentation solution:
It is noted that the cited process is a continuous process, wherein a portion of the whole bacterial mixture or a whole bacterial consortium comprising species of Bacillus, is recirculated to the anaerobic fermentation system (par. 0065, lines 8-10; see figure 1 dotted line between stage 6 and stage). Thus, a generic “bioaugmentation” solution comprising Bacillus is being formed and being dosed repeatedly to the anaerobic digester in the continuous process of methane production.
But the cited document US 2011/0151533 (Downey et al) does not explicitly describe steps of preparing a composition with a bacterial inoculum (claimed “bioaugmentation solution”) comprising Bacillus in an external incubator before addition to the anaerobic digester for production of methane from organic feedstock by bacterial consortium.
However, US 9,932,543 (Hashman et al) discloses a method of making a “bioaugmentation” composition comprising bacterial spores of Bacillus and a germinant (stimulant) for industrial applications including methane production (see col. 1, lines 13-15 and 29-30; see col. 9, lines 10-14; see col. 10, lines 39-57), wherein the composition is produced separately and then added to a waste material (or a feedstock) in the process for producing methane from the waste material (col. 9, lines 10-14). The bioaugmentation composition comprises Bacillus bacteria that are Bacillus licheniformis, Bacillus pumilus, Bacillus subtilis, Bacillus amyloliquefaciens, Bacillus simplex and Bacillus megaterium (col. 3, lines 26-40) as recited in claims (claims 38, 41 and 43 and 61). The cited US 9,932,543 (Hashman et al) explicitly recognizes hydrolysis (breakdown of waste materials) by Bacillus bacteria of the bioaugmentation composition to produce digestion products (or energy source) for methanogenic bacteria (see col. 22, lines 25-28) in anaerobic digestion system for production of methane (col. 22, lines 36-37).
Further, the cited document US 9,932,543 (Hashman et al) explicitly teaches and recognizes that heating induces spore germination (col.14, lines 7-15); that germinative compounds include amino acids and potassium ions (col.13, lines 15-20) and that spore germination and activation involve addition of water in combination with other factors including temperature, pH and salinity (col. 14, lines 29-37). The cited document US 9,932,543 (Hashman et) recognizes that germination of Bacillus spores depends on several conditions including presence of nutrient-germinant composition, temperature, and time. In particular, the germination is shown to be as high as 92% (see table 4) after 45 minutes of heating. However, germination rate increases with time; and, thus, is reasonably expected to be higher than 92% after exposure to the claimed heating time of 60 minutes.
Thus, as applied to the claimed method steps of forming and dosing bioaugmentation solution to the anaerobic digester, the cited document US 9,932,543 (Hashman et) as a whole teaches step of forming a bioaugmentation solution with Bacillus spores in an “external” container/incubator and suggests dosing the bioaugmentation solution to the anaerobic digester for methane production within the broadest reasonable meaning of the claims.
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to add and/or to use in the method of US 2011/0151533 (Downey et al) a separately prepared “bioaugmentation” composition comprising bacterial inoculum including spores of Bacillus and a nutrient-germinant as taught/suggested by US 9,932,543 (Hashman et al) with a reasonable expectation of success in improving performance of microbes in the anaerobic biodigester including microbial methane production biodigester because US 2011/0151533 (Downey et al) recognizes the use of a bacterial consortium including Bacillus in the process of converting organic feedstock material into methane and continuous recirculation or adding bioaugmentation mixture, because the cited US 9,932,543 (Hashman et al) explicitly recognizes hydrolysis (breakdown of waste material) by bacteria to produce digestion products (or energy source) for methanogenic bacteria (see col. 22, lines 25-28) and because US 9,932,543 (Hashman et al) teaches the use of bio-augmentation composition with spores of Bacillus and germinant for hydrolysis of waste materials in applications including methane production.
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
With regard to amounts of claim-recited “liquid nutrient germinant composition” and weight of “spore composition” in a bioaugmentation solution: the cited US 9,932,543 (Hashman et al) discloses concentration range of germinant compounds 0.0001%-17% (col. 13, last line) which overlaps the claimed range 6-10%. However, the weight of “spore composition comprising plurality of Bacillus spores” is a generic composition of unknown contents except for spores, and, thus, the differences, if any, cannot be evaluated. Nevertheless, the “nutrient-spore composition” of the cited US 10,610,552 (Everett et al), used for dispensing into waste water facilities (col. 2, line 43), comprises up to 10% of “nutrient-germinant composition” (col. 5, lines 20-25) and 10-90% of Bacillus spores (col. 5, lines 37-40) which is same and/or overlapping concentration ranges of components of the “nutrient-spore” composition as required for the claimed method (claim 38). Thus, claimed amounts are obvious variants.
With regard to claim-recited heating for spore germination and spore germination rate: the cited US 9,932,543 (Hashman et al) explicitly teaches and recognizes that heating induces spore germination (col.14, lines 7-15). In particular, germination is shown to be as high as 92% (see table 4) after 45 minutes of heating at 37°C. However, germination rate increases with increase of temperature and with increase time (table 5); and, thus, is reasonably expected to be higher than disclosed 92% upon exposure to higher heating temperature (of about 41-44°C as claimed) and/or upon for longer heating time (upon to 60 minutes at higher temperature). One of skill in the art would be obviously able to optimize time periods and temperatures for heat shock germination upon routine experimentation depending of specific materials and designs of operations. Moreover, the “nutrient-germinant composition” of US 10,610,552 (Everett et al) is used in combination with Bacillus spores (abstract; col. 5, lines 37-45) and provides for activation and germination of Bacillus spores upon heat treatment at temperature 41°C - 44°C for 2-60 minutes before dispensing a germinated Bacillus spore solution to a point-of-use (see abstract) including hydrolysis of waste materials (col. 6, lines 1-22). Thus, claimed heat treatment is obvious manipulation for spore germination.
With respect to limitation dawn to frequency and duration (3 or 5 and more doses daily over 30-35 days in claims 38, 40, 42, 71, 72) of adding a “bioaugmentation” composition comprising bacterial inoculum including spores of Bacillus it is noted that frequency/amount would be obviously optimized by one of skill in the art depending on specific feedstock, state of feedstock, conditions of industrial design for methane production from feedstock.
With regard to claim limitation drawn to CFU of Bacillus added to the digesters: Although the cited US 9,932,543 (Hashman et al) does not explicitly teach a dose of bacteria dispensed into biodigester as intended for hydrolysis and increase in methane production, the cited document recognizes that both hydrolysis and methane production are commonly practiced in liquid environments (col. 21, line 15). In particular the cited document suggests that doses for a liquid environment should be at the at least about 103 CFU/ml as claim-recited amount and up to 109CFU/ml (col. 23, line 6). It is obvious that one of skill in the art would/could optimize the CFU doses depending on specific application design and specific materials used upon routine experimentations involving specific materials and amounts of feedstock selected for application.
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
Further and with regard to the claim limitation as drawn to specific ingredients at their specific amounts in a “bioaugmentation” composition for Bacillus (claim 38 and also claims 44, 63, 65, 69, ):
First, as explained above, the cited US 9,932,543 (Hashman et al) discloses a method of making and using a “bioaugmentation” composition comprising bacterial spores of Bacillus and a germinant to improve performance of industrial applications including methane production (see col. 1, lines 13-15 and 29-30; see col. 9, lines 10-14; see col. 10, lines 39-57); wherein Bacillus bacteria include all 6 claim-recited species Bacillus amyloliquefaciens, Bacillus licheniformis, Bacillus pumillus, Bacillus circulans, Bacillus subtilis, Bacillus simplex and Bacillus megaterium (col. 3, lines 26-40). The cited US 9,932,543 (Hashman et al) explicitly recognizes hydrolysis (breakdown of waste material) by bacteria to produce digestion products (or energy source) for methanogenic bacteria (see col. 22, lines 25-28). Further, the cited document US 9,932,543 (Hashman et al) explicitly teaches and recognizes that heating spores induces germination (col.14, lines 7-15); that germinative compounds include amino acids and potassium ions (col.13, lines 15-20) and that spore germination and activation involve addition of water in combination with other factors including temperature, pH and salinity (col. 14, lines 29-37). The cited document US 9,932,543 (Hashman et) recognizes that germination of Bacillus spores depends on several conditions including presence of nutrient-germinant composition, temperature, and time; and that the germination is shown to be as high as 92% (see table 4).
In addition, the additional prior art reference teach the bioaugmentation compositions for various industrial applications as intended to deliver a biologically effective preparation of Bacillus spores that is functional in various systems including hydrolysis of waste materials suitable as feedstock in industrial applications as evidenced by US 10,610,552 (Everett et al) and by US 10,653,729 (Boyette et al) as explained in details below.
For example: see US 10,610,552 (Everett et al) at col. 4, lines 55-67 to col. 5, lines 1-15; wherein the cited document discloses “nutrient-spore composition” comprising spores and “nutrient-germinant composition” that is activated by heating before industrial applications at the point-of-use, wherein the “nutrient-germinant” composition comprises identical ingredients (L-amino acid or alanine, potassium, phosphate, Hepes, Tris, industrial preservatives) at the identical concentrations as recited in the pending claim 1. The “nutrient-germinant composition” of US 10,610,552 (Everett et al) is used in combination with Bacillus spores (abstract; col. 5, lines 37-45) and provides for activation and germination of Bacillus spores upon heat treatment at temperature 41°C - 44°C for 2-60 minutes before dispensing a germinated Bacillus spore solution to a point-of-use (see abstract) including hydrolysis of waste materials (col. 6, lines 1-22). The “nutrient-spore composition” of US 10,610,552 (Everett et al), when used for heating and dispensing, comprises up to 10% of “nutrient-germinant composition” (col. 5, lines 20-25) and 10-90% of Bacillus spores (col. 5, lines 37-40) which is same and/or overlapping concentration ranges of components of the “nutrient-spore” composition as required for the claimed method (claim 38) .
The other prior art reference, for example: US 10,653,729 (Boyette et al), teaches that in the applications based in the use of spore-containing products the Bacillus spores are provided as stabilized spore blends in a powdered form with 40-60% of salts and 60-40% of bacterial spores (col. 6, lines 30-33). The cited US 10,653,729 (Boyette et al) also teaches that the composition with bacterial spores (claimed “spore composition”) comprises: 1) acids as preservative including citric acid (col. 8, line 58) in amount 0.01-2% or 0.1-20g L (col. 6, line 16); 2) a thickener (col. 6, line 15) including xanthan gum (col.6, line 40); 3) a spore blend added as a powder in amount 0.1-10% or 1-100 g/L (col. 6, line 33); 4-5) various surfactants in amount up to 3% or 30g/L (col. 6, lines 14-15); and 6) additional acids as preservatives or “industrial preservatives” (col. 8, lines 57-62) in amount 0.01-2% or 0.1-20g L (col. 6, line 16).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to use concentrations of nutrient-germinant ingredients and of Bacillus spores as taught by US 10,610,552 (Everett et al) and by US 10,653,729 (Boyette et al) in the nutrient compositions for microbes including Bacillus spores in the methods of US 9,932,543 (Hashman) and US 2011/0151533 (Downey et al) with a reasonable expectation of success in activating/germinating Bacillus spores for subsequent applications including methane production because US 9,932,543 (Hashman) teaches the use of a composition comprising bacterial spores of Bacillus and germinant nutrients for hydrolysis of waste substrates and improving methane production, because “nutrient-spore” and “nutrient-germinant” compositions of identical contents and amounts as claimed have known and used for hydrolysis of waste materials as evidenced by US 10,610,552 (Everett et al) and by US 10,653,729 (Boyette et al) and because hydrolysis of waste materials by Bacillus spores activated by germinant nutrients has been known and used for subsequent increases in methane production as taught by US 9,932,543 (Hashman).
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
Further, as applied to claims 39, 64 and 68: the anaerobic fermentation system for methane production of US 2011/0151533 (Downey et al) is/can be a single stage digester (par. 0082) and it comprise or obviously would comprises a feedline for dosing or recirculating.
Limitations of claims 40-44, 61-63 are explained above as evidenced by the cited US 10,610,552 (Everett et al) and US 10,653,729 (Boyette et al).
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
Response to Arguments
Applicant's arguments filed on 12/16/2025 have been fully considered but they are not found persuasive.
With regard to claim rejection under 35 U.S.C. 103 as being unpatentable over US 2011/0151533 (Downey et al), US 9,932,543 (Hashman et al), US 10,610,552 (Everett et al) and US 10,653,729 (Boyette et al) Applicants main argument is that claimed method is not obvious because a significant number of possible combinations (taught and/or suggested by prior art as it appears to be argued) is unpredictable (response page 11).
This argument is not found persuasive with respect to the claimed method because claims recite a significant number of limitations that are knonw in the prior art in the field of applications for methane production by a mixed consortium of bacteria including Bacillus as a hydrolytic bacteria.
Applicants also argue that the use of a higher CFU dose was unexpectedly better for increase in methane production than the use of a low CFU dose (response page 11). However, a concept of a high dose advantage vs a low dose is generally considered to be obvious on its face. Most importantly, the scope of the showing must commensurate with the scope of claims to consider evidence probative of unexpected results. In the instant case, nature of the substrate for digestion is a generic food waste, Bacillus species are selected from a long non-specific list, a blend of germinant to provide for 95% germination is not specific. Moreover, the volume of digester and volume of liquid substrate to be digested are generic. The as-filed specification (par. 0043) appears to describe that level of operating capacity of digester is most important when specific dose is considered. It is confusing and unclear as claimed, as argued and as disclosed what provided for unexpected effects, if any. Besides, not a single claim recited a complete combination of all elements described in the specification example (par. 0042-0043). Moreover, criticality of using 6 species of Bacillus recited in claim 43 from 3-8 and more species of Bacillus of claim 38, is not demonstrated, particularly in view that same species of Bacillus are suggested for hydrolysis of waste substates in applications for methane production.
The cited prior art as a whole teaches and suggests the use of the species belonging to Bacillus, the use of germinant nutrients and heat treatment to increase spore germination, similar CFU amounts effective for treatment of liquid food waste systems. Thus, the cited references are in the same field of endeavor and they seek to solve the same problems as the instant application and claims, and one of skill in the art is free to select components available in the prior art, In re Winslow, 151 USPQ 48 (CCPA, 1966).
No claims are allowed.
Conclusion
THIS ACTION IS MADE FINAL. 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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Vera Afremova
February 15, 2026
/VERA AFREMOVA/ Primary Examiner, Art Unit 1653