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 .
Specification
The previous specification objection is withdrawn in light of the amendments.
Claim Objections
Claim 31 is objected to because of the following informalities:
Regarding claim 31, in line 3, the term “staggered operation” is in the line twice; please omit one instance of this term.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The previous 35 U.S.C. § 112(b) rejection is withdrawn in light of the amendments.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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-10, 15, and 24-31 are rejected under 35 U.S.C. 103 as being unpatentable over Jadhav (US 20250257371) (previously cited) in view of Alibek (US 20190309248) (previously cited) and Moll (US 20110189755) (previously cited).
Regarding claim 1, Jadhav discloses a system for propagating two or more microorganisms (paragraphs [0039] and [0053]) to mitigate mycotoxin contamination (paragraphs [0195]-[0196] and [0233]), wherein the system is configured to couple to one or more points of a process in a bioprocessing facility (Fig. 1B and paragraph [0047]) to inoculate at least a portion of the propagated composition and/or a composition derived from the propagated composition (Fig. 1B and paragraph [0047]) into one or more process compositions (Fig. 1B and paragraph [0047]) to mitigate mycotoxin contamination (paragraphs [0195]-[0196] and [0233]), wherein the bioprocessing facility is configured to produce one or more bioproducts from biomass (Fig. 1B and paragraph [0047]; “liquid CO2”, “ethanol”, “high protein concentrate”, and “fiber”).
Jadhav does not disclose:
expressing one or more enzymes to mitigate mycotoxin contamination
wherein the system comprises two or more propagation tanks, wherein each of the two or more propagation tanks comprises at least one microorganism expressing one or more enzymes to mitigate mycotoxin contamination, wherein at least one of the two or more propagation tanks comprises at least one microorganism that expresses one or more enzymes to mitigate mycotoxin contamination that is different from at least one microorganism that expresses one or more enzymes to mitigate mycotoxin contamination that is present in another propagation tank, wherein the system is configured to propagate the at least one microorganism that is present in each of the two or more propagation tanks and form a propagated composition comprising the at least one microorganism expressing one or more enzymes to mitigate mycotoxin contamination
Alibek discloses:
wherein the system comprises two or more propagation tanks (paragraph [0020]), wherein each of the two or more propagation tanks comprises at least one microorganism (paragraph [0078]) expressing one or more microbe-based compositions (paragraphs [0035]-[0036]), wherein at least one of the two or more propagation tanks comprises at least one microorganism that expresses one or more microbe-based compositions (paragraphs [0035]-[0036]) that is different from at least one microorganism that one or more microbe-based compositions (paragraphs [0035]-[0036]) that is present in another propagation tank (paragraph [0020]), wherein the system is configured to propagate the at least one microorganism that is present in each of the two or more propagation tanks and form a propagated composition comprising the at least one microorganism expressing one or more microbe-based compositions (paragraphs [0035]-[0036]).
In the analogous art of fermentation systems and methods, it would have been obvious to one skilled in the art before the effective filing date to modify the apparatus of Jadhav with the at least two tank system of Alibek in order to grow two different microorganisms and combine the resulting harvested material (Alibek, paragraphs [0036]-[0037]).
Moll discloses:
expressing one or more enzymes to mitigate mycotoxin contamination (paragraph [0022]).
In the analogous art of enzymatic decomposition of mycotoxins, it would have been obvious to one skilled in the art before the effective filing date to modify the system of modified Jadhav with the enzymes of Moll in order to degrade mycotoxins during the production of bioethanol in the mash for the production of alcohol, or to degrade and render harmless mycotoxins during the production of foods directly in the production process (Moll, paragraph [0010]).
Additionally, for clarity, regarding the limitation “at least one microorganism expressing one or more enzymes to mitigate mycotoxin contamination, wherein at least one of the two or more propagation tanks comprises at least one microorganism that expresses one or more enzymes to mitigate mycotoxin contamination that is different from at least one microorganism that expresses one or more enzymes to mitigate mycotoxin contamination that is present in another propagation tank”, Jadhav discloses at least two microorganisms, and modified Jadhav in view of Alibek describes two or more propagation tanks, each with microorganisms. It would have been obvious to one skilled in the art before the effective filing date to modify the apparatus of Jadhav to have at least two propagation tanks as in Alibek in order to grow two different microorganisms and combine the resulting harvested material.
Regarding claim 2, Jadhav does not disclose wherein the composition derived from the propagated composition in each of the two or more propagation tanks is chosen from a concentrated propagation broth, a lysate of the at least one microorganism, a concentrated lysate of the at least one microorganism, enzyme that is isolated from a propagation broth of the at least one microorganism, enzyme that is isolated from a lysate of the at least one microorganism, and combinations thereof.
Alibek discloses wherein the composition derived from the propagated composition in each of the two or more propagation tanks is chosen from a concentrated propagation broth (paragraph [0035]), a lysate of the at least one microorganism (paragraph [0035]), a concentrated lysate of the at least one microorganism (paragraphs [0035] and [0110]), and an enzyme that is isolated (paragraph [0042]).
In the analogous art of fermentation systems and methods, it would have been obvious to one skilled in the art before the effective filing date to modify the apparatus of Jadhav with the at least two tank system of Alibek in order to grow two different microorganisms and combine the resulting harvested material (Alibek, paragraphs [0036]-[0037]).
Regarding the phrase “enzyme that is isolated from a propagation broth of the at least one microorganism, enzyme that is isolated from a lysate of the at least one microorganism, and combinations thereof”, these limitations are recited in the alternative. Because the limitation has been met already, the remaining limitations need not be rejected at this time.
Regarding claim 3, Jadhav discloses a bioprocessing facility is configured to produce one or more bioproducts from biomass (Fig. 1B and paragraph [0047]; “liquid CO2”, “ethanol”, “high protein concentrate”, and “fiber”).
Jadhav does not disclose wherein the system is configured to be movable as a single unit among two or more bioprocessing facilities, wherein each bioprocessing facility is configured to produce one or more bioproducts from biomass.
Alibek discloses wherein the system is configured to be movable as a single unit (paragraphs [0064]-[0065]).
In the analogous art of novel fermentation systems and methods, it would have been obvious to one skilled in the art before the effective filing date to modify the system of modified Jadhav with the movability of Alibek (for instance, with wheels) in order to steer, push, pull, and transport the apparatus onto the back of a semi-truck trailer or any other kind of truck or trailer for portability (Alibek, paragraphs [0064]-[0065]).
Regarding the phrase “two or more bioprocessing facilities, wherein each bioprocessing facility is configured to produce one or more bioproducts from biomass”, Jadhav already discloses one of these bioprocessing facilities. The limitation is obvious under duplication of parts. Mere duplication of parts has no patentable significance unless a new and unexpected result is produced. MPEP § 2144.04(VI)(B). It would have been obvious to one skilled in the art before the effective filing date to modify the system of modified Jadhav to be used with two or more bioprocessing facilities in order to maximize the amount of probiotic culture that can be spread to the feedstock among several facilities so that the optimal total catabolism of mycotoxins can be achieved from any single probiotic culture system.
Regarding the limitation “among two or more bioprocessing facilities, wherein each bioprocessing facility is configured to produce one or more bioproducts from biomass”, the manner of operating or intended use of a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II). The device of modified Jadhav would be fully capable of operating in this manner given the at least two movable tanks of modified Jadhav.
Regarding claim 4, Jadhav discloses wherein the each of the two or more propagation tanks has a volumetric capacity of 10,000 gallons or less (paragraph [0233] “1 or 2 L volumes of 0.35 TSB in a to 1 tube to 1 L ratio”).
If it is deemed that Jadhav does not disclose the volumetric capacity above, Alibek discloses wherein the each of the two or more propagation tanks has a volumetric capacity of 10,000 gallons or less (claim 3).
In the analogous art of novel fermentation systems and methods, it would have been obvious to one skilled in the art before the effective filing date to modify modified Jadhav with the volumetric capacity of Alibek in order to scale the culture effectively depending on application, for instance, 50 gallons or smaller for bioremediation (Alibek, paragraph [0054]).
In addition, the claim limitation is obvious under MPEP § 2144.04(IV)(A), which states that “where the only difference between the prior art and the claims was a recitation of relative dimensions … [and the claimed device] would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device”. It would have been obvious to one skilled in the art before the effective filing date to modify modified Jadhav with the volumetric capacity of Alibek in order to scale the culture effectively depending on application, for instance, 50 gallons or smaller for bioremediation (Alibek, paragraph [0054]).
Regarding claim 5, Jadhav discloses wherein the each of the two or more propagation tanks has a volumetric capacity of 3,000 gallons or less (paragraph [0233] “1 or 2 L volumes of 0.35 TSB in a to 1 tube to 1 L ratio”).
If it is deemed that Jadhav does not disclose the volumetric capacity above, Alibek discloses wherein the each of the two or more propagation tanks has a volumetric capacity of 3,000 gallons or less (claim 3).
In the analogous art of novel fermentation systems and methods, it would have been obvious to one skilled in the art before the effective filing date to modify modified Jadhav with the volumetric capacity of Alibek in order to scale the culture effectively depending on application, for instance, 50 gallons or smaller for bioremediation (Alibek, paragraph [0054]).
In addition, the claim limitation is obvious under MPEP § 2144.04(IV)(A), which states that “where the only difference between the prior art and the claims was a recitation of relative dimensions … [and the claimed device] would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device”. It would have been obvious to one skilled in the art before the effective filing date to modify modified Jadhav with the volumetric capacity of Alibek in order to scale the culture effectively depending on application, for instance, 50 gallons or smaller for bioremediation (Alibek, paragraph [0054]).
Regarding claim 6, Jadhav does not disclose wherein the two or more propagation tanks comprises three or more propagation tanks, wherein each of the three or more propagation tanks comprises at least one microorganism expressing one or more enzymes to mitigate mycotoxin contamination, wherein at least one of the three or more propagation tanks comprises at least one microorganism that expresses one or more enzymes to mitigate mycotoxin contamination that is different from at least one microorganism that expresses one or more enzymes to mitigate mycotoxin contamination that is present in another propagation tank, wherein the system is configured to propagate the at least one microorganism that is present in each of the three or more propagation tanks and form a propagated composition comprising the at least one microorganism expressing one or more enzymes to mitigate mycotoxin contamination, and wherein the system is configured to couple to one or more points of a process in a bioprocessing facility to inoculate at least a portion of the propagated composition and/or a composition derived from the propagated composition from each of the three or more propagation tanks into one or more process compositions to mitigate mycotoxin contamination, wherein the bioprocessing facility is configured to produce one or more bioproducts from biomass.
Alibek discloses at least two propagation tanks (paragraph [0020]).
In the analogous art of fermentation systems and methods, it would have been obvious to one skilled in the art before the effective filing date to modify the apparatus of Jadhav with the at least two tank system of Alibek in order to grow at least two different microorganisms and combine the resulting harvested material (Alibek, paragraphs [0036]-[0037]).
Moll discloses at least three different enzyme sequences for mycotoxin decontamination (paragraph [0010]).
In the analogous art of enzymatic decomposition of mycotoxins, it would have been obvious to one skilled in the art before the effective filing date to modify the system of modified Jadhav with the enzymes of Moll in order to degrade mycotoxins during the production of bioethanol in the mash for the production of alcohol, or to degrade and render harmless mycotoxins during the production of foods directly in the production process (Moll, paragraph [0010]).
Additionally, regarding the limitation, mere duplication of parts has no patentable significance unless a new and unexpected result is produced. MPEP § 2144.04(VI)(B). It would have been obvious to one skilled in the art before the effective filing date to modify modified Jadhav with a third propagation tank in accordance with the claim limitation in order to provide a third enzyme for mycotoxin decontamination.
Regarding claim 7, Jadhav does not disclose wherein the system is configured to remove and adjustably combine at least a portion of the contents of at least two propagation tanks in a volumetric ratio of 1:1 or different than 1:1.
Alibek discloses wherein the system is configured to remove and adjustably combine at least a portion of the contents of at least two propagation tanks (paragraph [0020] via “tubing”) in a volumetric ratio of 1:1 or different than 1:1 (inherent to a ratio of 1:1 or a ratio other than 1:1 to combining two volumes).
In the analogous art of novel fermentation systems and methods, it would have been obvious to one skilled in the art before the effective filing date to modify modified Jadhav with the combination of the contents of the at least two propagation tanks of Alibek in order to balance the culture levels in each tank and to produce microbe-based compositions that can be used in the oil and gas industry, agriculture, health care and environmental cleanup (Alibek, paragraph [0017] and [0020]).
In addition, regarding the limitation “adjustably combine”, according to MPEP § 2144.04(V)(D), adjustability of a part is not a patentable advance. It would have been obvious to one skilled in the art before the effective filing date to modify the volumetric ratio of the at least two propagation tanks of modified Jadhav in order to balance the culture levels in each tank and to produce microbe-based compositions that can be used in the oil and gas industry, agriculture, health care and environmental cleanup (Alibek, paragraph [0017] and [0020]).
Regarding the volumetric ratio of the limitation, if it is deemed that modified Jadhav does not disclose the limitation “in a volumetric ratio of 1:1 or different than 1:1”, the claim limitation is obvious under MPEP § 2144.04(IV)(A), which states that “where the only difference between the prior art and the claims was a recitation of relative dimensions … [and the claimed device] would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device”. It would have been obvious to one skilled in the art before the effective filing date to modify modified Jadhav with a volumetric ratio in order to combine the microbial compositions located in each tank and to produce microbe-based compositions that can be used in the oil and gas industry, agriculture, health care and environmental cleanup (Alibek, paragraph [0017] and [0020]).
Regarding the limitation, the manner of operating or intended use of a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II). The device of modified Jadhav would be fully capable of operating in this manner given the at least two propagation tanks and the tubing connecting them.
Regarding claim 8, Jadhav discloses coupling to one or more one or more points in the bioprocessing facility (Fig. 1B and paragraphs [0047] and [0098]-[0100]) to receive a composition chosen from a nutrient source, a carbon source, and combinations thereof (paragraph [0052] “feedstock”).
Jadhav does not disclose wherein at least one of the two or more propagation tanks.
However, modified Jadhav already teaches this limitation (see rejection to claim 1 above).
Regarding claim 9, Jadhav does not disclose further comprising a storage system in fluid communication with at least one of the two or more propagation tanks, wherein the storage systems is configured to receive at least a portion of contents directly or indirectly from the at least one of the two or more propagation tanks, wherein the storage system comprises one or more storage containers, wherein each storage container has a capacity of 150 gallons or less.
Alibek discloses at least two propagation tanks in fluid communication (paragraph [0020] via “tubing”), wherein each propagation tank has a capacity of 150 gallons or less (claim 3 and paragraph [0054]).
In the analogous art of fermentation systems and methods, it would have been obvious to one skilled in the art before the effective filing date to modify the apparatus of Jadhav with the at least two tank system of Alibek in order to grow two different microorganisms and combine the resulting harvested material (Alibek, paragraphs [0036]-[0037]).
Regarding the limitation “a storage system in fluid communication with at least one of the two or more propagation tanks, wherein the storage systems is configured to receive at least a portion of contents directly or indirectly from the at least one of the two or more propagation tanks, wherein the storage system comprises one or more storage containers, wherein each storage container has a capacity of 150 gallons or less”, these storage containers that are in fluid communication with the two or more propagation tanks are considered obvious under duplication of parts. Regarding the limitations “containers” and “tanks”, mere duplication of parts has no patentable significance unless a new and unexpected result is produced. MPEP § 2144.04(VI)(B). In addition, the claim limitation is obvious under MPEP § 2144.04(IV)(A), which states that “where the only difference between the prior art and the claims was a recitation of relative dimensions … [and the claimed device] would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device”. It would have been obvious to one skilled in the art before the effective filing date to modify modified Jadhav with the volumetric capacity of Alibek in order to scale the culture effectively depending on application, for instance, 50 gallons or smaller for bioremediation (Alibek, paragraph [0054]).
Regarding claim 10, Jadhav does not disclose further comprising a lysis system in fluid communication with at least one of the two or more propagation tanks, wherein the lysis system is configured to form a lysate with at least a portion of propagated composition from the at least one of the two or more propagation tanks.
Alibek discloses further comprising a lysis system with at least one of the two or more propagation tanks (paragraph [0020]), wherein the lysis system is configured to form a lysate with at least a portion of propagated composition from the at least one of the two or more propagation tanks (paragraphs [0035]-[0036] “lysed”).
In the analogous art of novel fermentation systems and methods, it would have been obvious to one skilled in the art before the effective filing date to modify the system of modified Jadhav with the lysis system of Alibek in order to provide an enzymatic product that can be isolated, purified, and provided in a composition (Alibek, paragraphs [0036] and [0040]-[0042]).
Regarding the limitation “in fluid communication”, this is obvious under integration of parts (such as tubing connecting the two or more propagation tanks with the lysis system). Integration of parts would have been obvious to one of ordinary skill in the art as a matter of obvious engineering choice. MPEP § 2144.04(V)(B). It would have been obvious to one skilled in the art before the effective filing date to modify modified Jadhav with the fluid communication between the propagation tanks and the lysis system in order to make a continuously pumping and operating system throughout the process of fermentation (Alibek, paragraph [0021]).
Regarding claim 15, Jadhav discloses wherein the system is configured to control the temperature of the enzyme present in the system to be 110°F or less (paragraph [0228], incubation with bacteria expressing mycotoxin-degrading enzymes occurs at 30°C; inherently, this temperature is equivalent to 86°F).
If it is deemed that Jadhav does not disclose the limitation above, Alibek discloses wherein the system is configured to control the temperature (paragraphs [0055]-[0059] and [0061]) of the enzyme present in the system to be 110°F or less (paragraph [0088], incubation with microorganisms expressing mycotoxin-degrading enzymes occurs in a range of about 5° to about 100° C).
In the analogous art of novel fermentation systems and methods, it would have been obvious to one skilled in the art before the effective filing date to modify the system of modified Jadhav with the temperature and temperature control of Alibek in order to maintain an appropriate temperature for fermentation and the production of desired metabolites such as enzymes (Alibek, paragraphs [0056], [0118], and [0129]).
Additionally, regarding the limitation, the manner of operating or intended use of a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II). The device of modified Jadhav would be fully capable of operating in this manner given the at least two tanks.
Regarding claim 24, Jadhav does not disclose wherein each of the two or more propagation tanks comprises a respective discharge stream in fluid communication with one or more downstream processes.
Alibek discloses each of the two or more propagation tanks (paragraph [0020]) comprises a respective discharge stream in fluid communication (paragraph [0109] “piped”) with one or more downstream processes (paragraph [0109] addition of further components or additives).
In the analogous art of fermentation systems, it would have been obvious to one skilled in the art before the effective filing date to modify modified Jadhav with further components or additives of Alibek in order to modify the viscosity of the microbe-based composition, add nutrients for plant or microbe growth, and/or food products (such as those for animal feed) (Alibek, paragraph [0109]).
Regarding claim 25, Jadhav discloses a storage system comprising a storage system comprising a storage tank (paragraphs [0268] and [0275]-[0276] “beer well tank”); and, to combine the contents in the storage tank (paragraph [0268]).
Jadhav does not disclose wherein the storage tank is configured to receive contents from each of the two or more propagation tanks and to combine the contents in the storage tank to form an enzyme cocktail.
Alibek discloses wherein storage tanks (paragraph [0166] “20 L or 40 L carboys”) are configured to receive contents from each of the two or more propagation tanks (paragraph [0020]).
In the analogous art of fermentation systems, it would have been obvious to one skilled in the art before the effective filing date to modify the storage tank of modified Jadhav with receiving contents from the propagation tanks of Alibek in order to transport the contents for use (Alibek, paragraph [0109]).
Regarding the limitation “to form an enzyme cocktail”, Moll discloses at least three different enzyme sequences for mycotoxin decontamination (paragraph [0010]).
In the analogous art of enzymatic decomposition of mycotoxins, it would have been obvious to one skilled in the art before the effective filing date to modify the system of modified Jadhav with the enzymes of Moll in order to degrade mycotoxins during the production of bioethanol in the mash for the production of alcohol, or to degrade and render harmless mycotoxins during the production of foods directly in the production process (Moll, paragraph [0010]).
Regarding claim 26, Jadhav discloses wherein the storage system comprises a dedicated storage tank (paragraphs [0268] and [0275]-[0276] “beer well tank”).
Jadhav does not disclose wherein the storage system comprises a dedicated storage tank for each propagation tank.
Alibek discloses wherein the storage system comprises a dedicated storage tank for each propagation tank (paragraph [0166] “either 20 L or 40 L carboys”).
In the analogous art of fermentation systems, it would have been obvious to one skilled in the art before the effective filing date to modify modified Jadhav with the dedicated storage tank for each propagation tank of Alibek in order to compare between batches of fermented harvest material for quality measures.
If it is deemed that modified Jadhav does not disclose this limitation, mere duplication of parts has no patentable significance unless a new and unexpected result is produced. MPEP § 2144.04(VI)(B). It would have been obvious to one skilled in the art before the effective filing date to modify modified Jadhav with the duplicated dedicated storage tank for each propagation tank in order to compare between batches of fermented harvest material for quality measures.
Regarding claim 27, Jadhav discloses wherein the storage system (paragraphs [0268] and [0275]-[0276] “beer well tank”).
Jadhav does not disclose wherein the storage system is configured to temporarily stage a propagated composition or a composition derived from the propagated composition prior to inoculating a process composition in the bioprocessing facility.
Alibek discloses wherein the storage system (paragraph [0166] “20 L or 40 L carboys”) is configured to temporarily stage a propagated composition or a composition derived from the propagated composition prior to inoculating a process composition in the bioprocessing facility (paragraph [0166] “the reactors were inoculated”).
In the analogous art of fermentation systems, it would have been obvious to one skilled in the art before the effective filing date to modify modified Jadhav with the storage system of Alibek in order to hold the propagated composition or a composition derived from the propagated composition in short-term storage for enzymatic stabilization (for proteins) in a refrigerated or cool environment.
Regarding the limitation “temporarily”, the manner of operating or intended use of a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II). The device of modified Jadhav would be fully capable of operating in this manner given the structures of the storage system and its inoculation of the composition.
Regarding claim 28, Jadhav does not disclose wherein the system is configured to control proportionality of the contents received from each of the two or more propagation tanks to form the enzyme cocktail.
Alibek discloses wherein the system is configured to control proportionality (paragraph [0036] “mixtures of microbe-based compositions”) of the contents received from each of the two or more propagation tanks (paragraph [0020]) to form the microbial composition.
In the analogous art of fermentation systems and methods, it would have been obvious to one skilled in the art before the effective filing date to modify the apparatus of Jadhav with the at least two tank system of Alibek in order to grow two different microorganisms and combine the resulting harvested material (Alibek, paragraphs [0036]-[0037]).
Regarding the limitation “enzyme cocktail”, Moll discloses at least three different enzyme sequences for mycotoxin decontamination (paragraph [0010]).
In the analogous art of enzymatic decomposition of mycotoxins, it would have been obvious to one skilled in the art before the effective filing date to modify the system of modified Jadhav with the enzymes of Moll in order to degrade mycotoxins during the production of bioethanol in the mash for the production of alcohol, or to degrade and render harmless mycotoxins during the production of foods directly in the production process (Moll, paragraph [0010]).
Regarding the limitation “control proportionality of the contents received”, the limitation is obvious as a matter of routine optimization, because the proportionality of the contents received is a result-effective variable. The motivation for optimizing this result-effective variable is to create a mixed composition that fulfills the optimal needs for the industry involved that necessitates the microbial composition, e.g. pharmaceutical fields, medical fields, cosmetics, household products, industrial and agricultural uses (Alibek, paragraphs [0003] and [0138]). MPEP § 2144.05(II).
Regarding claim 29, Jadhav discloses the storage tank (paragraphs [0268] and [0275]-[0276] “beer well tank”).
Jadhav does not disclose wherein the two or more propagation tanks and the storage tank are mounted on a skid that is configured to be movable as a single unit.
Alibek discloses wherein the two or more propagation tanks (paragraph [0020]) and storage tanks (paragraph [0166] “20 L or 40 L carboys”) are mounted on a skid that is configured to be movable as a single unit (paragraph [0064] “a frame for supporting the apparatus components … system can include wheels for moving the apparatus”).
In the analogous art of fermentation systems, it would have been obvious to one skilled in the art before the effective filing date to modify modified Jadhav’s system with a skid of Alibek in order to transport the system onto a trailer for transportation to different locations.
Regarding claim 30, Jadhav does not disclose wherein the system is configured to propagate microorganisms in the two or more propagation tanks using two or more different propagation protocols to form different propagated compositions, and wherein the system is configured to combine at least a portion of the different propagated compositions external to the two or more propagation tanks to form a combined product composition.
Alibek discloses wherein the system is configured to propagate microorganisms (paragraphs [0019] and [0078]) in the two or more propagation tanks (paragraph [0020]) using two or more different propagation protocols to form different propagated compositions (paragraph [0023]-[0024]), and wherein the system is configured to combine at least a portion of the different propagated compositions external to the two or more propagation tanks to form a combined product composition (paragraph [0036]).
In the analogous art of fermentation systems, it would have been obvious to one skilled in the art before the effective filing date to modify modified Jadhav during the configuration of the system to combine different compositions of Alibek in order to produce a processed microbe-based composition that is based on a mixture of compositions for the bio-preparations used in food industries, pharmaceuticals, agriculture, mining, environmental remediation, and waste management (Alibek, paragraph [0003]).
Regarding claim 31, Jadhav does not disclose wherein the two or more propagation tanks are configured to be operated relative to each other in a manner chosen from serial operation, parallel operation, staggered operation, and temporarily staged operation.
Alibek discloses wherein the two or more propagation tanks (paragraph [0020]) are configured to be operated relative to each other in a manner chosen from serial operation (paragraph [0044]).
In the analogous art of fermentation systems, it would have been obvious to one skilled in the art before the effective filing date to modify modified Jadhav with the serial operation of the two or more propagation tanks in order to create fermentation tanks that operate at different parameters (such as different enzymes) in order to most optimally reduce mycotoxins.
If it is deemed that the disclosure above does not fulfill the limitation above, rearrangement of parts would have been obvious to one of ordinary skill in the art as an obvious matter of design choice and would not have modified the operation of the device. MPEP § 2144.04(VI)(C). It would have been obvious to one skilled in the art before the effective filing date to modify modified Jadhav with the serial or parallel operation of the two or more propagation tanks in order to create fermentation tanks that operate at different parameters (such as different enzymes) in order to most optimally reduce mycotoxins; parallel operation is obvious as well in order to increase total volume of fermentation harvest.
Regarding the limitation “parallel operation, staggered operation, and temporarily staged operation”, the limitation is phrased in the alternative. Because at least one of the limitations is rejected above, no further rejections are required at this time.
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Jadhav (US 20250257371) (previously cited) in view of Alibek (US 20190309248) (previously cited) and Moll (US 20110189755) (previously cited) as applied to claim 10, further in view of Garnham (US 20210337838) (previously cited).
Regarding claim 11, Jadhav does not disclose further comprising a source of one or more protease inhibitors, wherein the system is configured to combine the one or more protease inhibitors with the lysate.
Garnham discloses comprising a source of one or more protease inhibitors, wherein the system is configured to combine the one or more protease inhibitors with the lysate (paragraph [0191]).
In the analogous art of mycotoxin detoxification, it would have been obvious to one skilled in the art before the effective filing date to modify the system of Jadhav with the protease inhibitor and lysate combination of Garnham in order to preserve the mycotoxin-detoxifying enzymes that could be destroyed by proteases after lysing the microbial cells producing those enzymes.
Regarding claim 12, Jadhav does not disclose wherein the system is configured to combine the one or more protease inhibitors with the lysate at a weight ratio in a range from 1:10,000 to 1:10.
However, the limitation is obvious as a matter of routine optimization, because the weight ratio of protease inhibitor to the lysate is a result-effective variable. The motivation for optimizing this result-effective variable is to promote the preservation of mycotoxin-detoxifying enzymes while requiring a minimal amount of protease inhibitor to do so. MPEP § 2144.05(II).
Regarding claim 13, Jadhav does not disclose wherein the system is configured to combine the one or more protease inhibitors with the lysate at a weight ratio in a range from 1:10,000 to 1:1000.
However, the limitation is obvious as a matter of routine optimization, because the weight ratio of protease inhibitor to the lysate is a result-effective variable. The motivation for optimizing this result-effective variable is to promote the preservation of mycotoxin-detoxifying enzymes while requiring a minimal amount of protease inhibitor to do so. MPEP § 2144.05(II).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Jadhav (US 20250257371) (previously cited) in view of Alibek (US 20190309248) (previously cited) and Moll (US 20110189755) (previously cited) as applied to claim 1, further in view of Homan (US 20060147442) (previously cited).
Regarding claim 14, modified Jadhav teaches one or more points in the system (Fig. 1B and paragraph [0047]).
Jadhav does not disclose further comprising a source of one or more stabilizers, wherein the system is configured to combine the one or more stabilizers with at least one propagated composition and/or a composition derived from the at least one propagated composition at one or more points in the system.
Homan discloses further comprising a source of one or more stabilizers, wherein the system is configured to combine the one or more stabilizers with at least one propagated composition and/or a composition derived from the at least one propagated composition (paragraphs [0104], [0337], and [0343]).
In the analogous art of biocides, it would have been obvious to one skilled in the art before the effective filing date to modify the system of modified Jadhav with the one or more stabilizers of Homan in order to increase the solubility of the compounds to allow for the preparation of highly concentrated solutions (Homan, paragraph [0337]).
Additional Prior Art References
The prior art made of record and not relied upon is considered pertinent to Applicant’s disclosure.
Ziegler (US 20080206215) (newly cited) – This invention is a fermentation apparatus that includes chlorine dioxide for the elimination of toxic or wild yeasts, molds, and bacteria.
Response to Arguments
Applicant’s arguments filed 07/02/2026 have been fully considered but they are not persuasive.
Regarding pg. 10 of 18 of Applicant remarks, the specification objection and 112(b) rejections are withdrawn in light of the amendments.
Regarding pg. 11 of 18 of Applicant remarks, the 103 rejection stands as the combination of references, i.e. Jadhav in view of Alibek and Moll, has not been fully rebutted. Moll especially has not been addressed.
Regarding pg. 12 of 18 of Applicant remarks, Alibek is disclosed to show that at least one of the two or more propagation tanks comprises at least one microorganism that express a composition. Applicant’s argument that relies upon the lack of disclosure of “one or more enzymes to mitigate mycotoxin contamination” in Jadhav or in Alibek does not address Moll’s disclosure of “expressing one or more enzymes to mitigate mycotoxin contamination” (Moll, paragraph [0022]), with the motivation to degrade mycotoxins during the production of bioethanol … or to degrade and render harmless mycotoxins during the production of foods directly in the production process (Moll, paragraph [0010]).
Regarding pg. 13 of 18 of Applicant remarks, the Office Action has addressed the reasons for mycotoxin degradation via one or more enzymes, see above.
Regarding pg. 14 of 18 of Applicant remarks, the limitation “that is present in another propagation tank” is also a form of intended use or a manner of operation of the system comprising microorganisms.
Regarding pg. 14 of 18 of Applicant remarks, regarding the dependent claim 3, the reason for modifying the primary reference Jadhav is clearly delineated: in order to transport the apparatus onto a semi-truck trailer or any other truck or trailer for portability (Alibek, paragraphs [0064]-[0065]). Further explanation, such as for portability, could be for the ability to move the apparatus via a road system to another location (as cargo of a semi-truck trailer). In this fashion, the system would be able to be manufactured and transported to multiple sites for bioethanol and safe food production, see Moll’s explanation above.
Regarding pg. 15 of 18 of Applicant remarks, regarding the dependent claim 7, Alibek discloses that there are at least two tanks that are connected to each other by tubing (Alibek, paragraph [0020]), where tanks’ compositions are pumped into each other and provides mixing in a multi-tank reactor. Because there are at least two different tank compositions that are mixing, there is at least a combination of at least a portion of the contents of at least two propagation tanks in a volumetric ratio of 1:1 or different than 1:1.
Regarding the dependent claims, these claims are rejected as the independent claim is still rejected and no further arguments were made regarding the dependent claims.
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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/N.G.E./Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799
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