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 .
Response to Amendment
Applicant’s remarks and amendments filed 11/18/2025, in response to the non-final rejection mailed 8/19/2025, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn. Applicant’s amendment to the claims is acknowledged. This listing of the claims replaces all prior versions and listings of the claims.
Claims 1-28, 34, 40, and 44-45 have been cancelled. Claims 29-33, 35-39, 41-43, and 46-49 are pending. Claims 46-48 remain withdrawn. Claim 49 is new.
Claims 29-33, 35-39, 41-43, and 49 have been examined on the merits.
Response to Arguments
Applicant’s arguments, see pages 8-17 of the remarks filed 11/18/2025, with respect to the prior rejections of claims 29-31 and 35-43 under 35 U.S.C. § 103 as being obvious over the cited art of record have been fully considered. The declaration of Dr. Rotem Tidhar under 37 CFR 1.132 filed 11/18/2025 is sufficient to overcome the rejection of claims 29 and 34-42 as being obvious over the combined teachings of Otto (US Patent No. 8,119,376), in view of Uchida et al. (WO2005100543) and “Tartu” (WO2008043368).
The arguments and declaration as evidence are persuasive in view of the amendment to the claims to recite the mixed food waste as a fermentation substrate, which is not taught in the previously cited art. Therefore, the rejection has been withdrawn.
However, upon further consideration, new grounds of rejection are made herein in view of additional consideration and further searching of the art, necessitated by Applicant's amendments.
In response to Applicant’s arguments pertaining to the relevant portions of the art previously applied and presented in the new rejections, the following responses are noted.
First, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that at least one or more of the features upon which applicant relies (i.e., that there is direct inoculation without activation steps) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The claims recite that the dried composition of spores is inoculated into the substrate, but the claims are comprising-type claims and claims 29 and 49 each recite “incubating the mixture in the fermentation reactor to saccharify the organic waste and induce germination of the spores... ”. Although the presented arguments indicate that there are no such activation steps, the claimed invention recites that the activation steps occur simultaneously with the saccharification, which amounts to a change in sequence of steps or sequence of process steps. MPEP 2144.04.IV.C. describes that such rearrangement of steps are obvious in the absence of unexpected results (i.e. it would have been obvious to perform the activation after inoculation to coincide with the saccharification, because both steps are known in the art and require heating, and the predictable result is that the steps are accomplished together). See “Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959) (Prior art reference disclosing a process of making a laminated sheet wherein a base sheet is first coated with a metallic film and thereafter impregnated with a thermosetting material was held to render prima facie obvious claims directed to a process of making a laminated sheet by reversing the order of the prior art process steps.). See also In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results); In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.)”.
In the instant case, although Applicant argues that the invention is different from that taught in “Tartu” because the prior art teaches heat activation of spores, this is not considered a persuasive argument because the heat activation still occurs in the instantly claimed method, just at a different step/time. Uchida was cited, in part, due to the teachings therein that spores of a related species can germinate and grow quickly when the environmental conditions are adjusted such that preliminary culture does not need to be performed before lactic acid fermentation. Applying the method of adding spores taught in Uchida, to any known similar spore-producing species of lactic acid bacillus would thus amount to a predictable improvement to one of ordinary skill. See MPEP § 2143.I, KSR Rationale C.
In response to applicant's argument that the combination of the teachings of Otto, Uchida, and Tartu does not teach or suggest the use of the dried endospores for fermenting waste to produce lactic acid, it is noted that 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).
In the instant case, these references have been cited as to provide knowledge regarding the different means of applying B. coagulans endospores (as in Tartu) or those of a closely related useful species (the Bacillus “SANK” species described in Uchida). However, the portion of Uchida cited by the Applicant does not represent a teaching away, and instead the reference is relied upon to establish the level of ordinary skill in the art and to demonstrate that one having ordinary skill would be well aware of useful lactic acid bacteria, their endospores, and means to utilize these spores. Further, one having ordinary skill would be motivated to optimize the methods taught in Otto, Uchida, and Tartu. These references describe various parameters suited for optimization when seeking to improve fermentation producing L-lactic acid.
MPEP 2141.II.C describe that: "A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR, 550 U.S. at 421, 82 USPQ2d at 1397. "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle."Id. at 420, 82 USPQ2d at 1397. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ."Id. at 418, 82 USPQ2d at 1396.
Regarding the concentration of the spores, MPEP § 2144.05 describes that the determination of a suitable or effective concentration of previously known composition, or performing a known method, can be determined by one of ordinary skill in the art through the use of routine or manipulative experimentation to obtain optimal results, as concentration is a well-known variable parameter within the art. “Where 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).”
Thus, although the Applicant’s argue that the cited references would have not rendered obvious the claimed invention using dried endospores of B. coagulans for mixed substrate fermentation, these teachings are considered relevant for all the reasons previously stated.
Claim Rejections - 35 USC § 103
(New and/or Modified as necessitated by Amendment)
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 29, 35-39, 41-42, and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Otto (US Patent No. 8,119,376) in view of Sakai and Yutaka (“Open L-lactic acid fermentation of food refuse using thermophilic Bacillus coagulans and fluorescence in situ hybridization analysis of microflora.” Journal of bioscience and bioengineering vol. 101,6 (2006): 457-63. doi:10.1263/jbb.101.457, termed herein after “Sakai”), “Uchida” (WO2005100543), and “Tartu” (WO2008043368, of record).
Otto pertains to a method for the production of lactic acid or a salt thereof comprising a process of simultaneous saccharification and fermentation, the method comprising saccharifying a starch in a medium comprising at least a glucoamylase and simultaneously fermenting the starch using a microorganism (Abstract, claim 1). Otto teaches that “glucoamylase' means an enzyme belonging to the functional-class with the EC number 3.2.1.3 and that other names include γ-amylase, lysosomal C-glucosidase, a glucoamylase, acid maltase, exo-1,4-O-glucosidase, glucozyme, AMG®, or GAM (Col 2, lines 20-28). Otto also teaches a system that combine saccharification and fermentation, which are known as “simultaneous saccharification and fermentation” (SSF) processes (Col 2, lines 29-43).
Otto teaches that the raw material to obtain the starch energy sources may be milled (whole) cereals or rasped, shredded roots (potato, tapioca), tubers, whole grains, corns, cobs, wheat, barley, rye, milo, sugar-containing raw materials, such as molasses, fruit materials, sugar, cane or sugar beet, potatoes, cellulose-containing materials, such as wood or plant residues (Col 7, lines 1-13). Thus Otto suggests, inter alia, that the material may include organic waste or residue that has been treated (i.e. milled or shredded) with a reduction in size.
Otto teaches in one example performing simultaneous saccharification and fermentation using a glucoamylase (AMG® from Novozymes®) with Bacillus coagulans in a controlled jacketed stirred reactor fermenter (e.g. a fermentation reactor) and the temperature was controlled at 54-56°C, the pH set point was a compromise between the optimum pH of the enzyme and the optimum for Bacillus coagulans, adapted to pH 5.65, and the culture occurred for 30-40 hours (Col 7, line 55 – Col 8, line 67). Otto teaches that Bacillus coagulans had the highest lactic acid yield of the organisms tested therein, with a high purity (Table 2, first row).
Otto teaches that a starch slurry or slurry of a starch-containing material or liquefied starch is fed into a fermenter with a microbial inoculum and nutrients, and that during the fermentation a suitable base such as calcium hydroxide, sodium hydroxide, potassium hydroxide, magnesium hydroxide, magnesium oxide, ammonia, ammonium hydroxide or a suitable carbonate may be added for pH control (Col 6, lines 49-58).
However, Otto does not teach explicitly that dried spores of Bacillus coagulans are added to the vessel for simultaneous saccharification and fermentation, nor that the fermentation substrate is an organic waste comprising a mixed food waste as in the amended claims.
Sakai teaches a method for producing L-lactic acid with fermentation of model kitchen refuse (MKR) inoculated with Bacillus coagulans NBRC12583 under open culture conditions (Title, Abstract). Sakai teaches that L-lactic acid was selectively accumulated by incubation at 50–65°C and that B. coagulans dominated the fermentation at the higher temperatures (Abstract, Figure 4 and Table 2). For the organic waste substrate, Sakai teaches that the model kitchen refuse (MKR) had the following composition (in % w/w): 14% fish residue, 40% vegetables (carrot, potato and Chinese radish peel), 30% fruit (banana, apple and orange peel), 10% cooked rice and 6% green tea residue (pg. 458, right col under “Open fermentation of kitchen refuse”). Sakai states that “MKR was saccharified by glucoamylase for 2 h and fermented by B. coagulans without sterilization at 55°C under continuous pH control at 6.5, 40 g/l L-lactic acid accumulated after 48 h (Fig. 5)” (pg. 461, right col, last paragraph). Sakai teaches that the MKR preparations were inoculated with B. coagulans cells (2.5%, v/v, about 106 cells/ml) (pg. 458, right col under “Open fermentation of kitchen refuse”). Sakai teaches the production of high quality L-lactic acid using such conditions (see Tables 2 and 3), and states that “the spore-forming characteristic of B. coagulans is advantageous for the stocking and distribution of the seed culture. We found that the kitchen refuse fermented with B. coagulans at 55°C could be used as a seed culture for subsequent fermentation reactions” (pg. 462, right col). Thus, Sakai teaches that B. coagulans can successfully ferment a combination of food wastes at conditions the same as that claimed herein. It is noted that the conditions in Sakai are “open fermentation” and thus are nonsterile. However, in the instant invention, the sterilization steps are optional and the specification provides no evidence that sterilization leads to unexpected success.
Uchida teaches a method of producing L-lactic acid by using a novel bacterial strain Bacillus SANK 70182 strain (Abstract), and a process for producing L-lactic acid comprising the first step of hydrolyzing a woody biomass to give a sugar-containing substrate and the second step of subjecting the substrate to lactic acid fermentation using the Bacillus strain (Abstract, Claim 5). Uchida teaches that spores are preferably used (pg 3, 4th paragraph of the English translation). The strain in Uchida is closely related to the spore-forming species Bacillus coagulans (see pg 7 under “4. Genetic characteristics” and Figure 1).
In one embodiment, Uchida states “culturing the SANK 70182 strain in a fermentation medium containing a carbon source substrate, a nitrogen source such as CSL [corn steep liquor], and an inorganic salt such as magnesium sulfate in a fermentation vessel. A liquid, dried cells or spores are added, and the cells are cultured for a certain period of time in the above temperature range. At this time, the pH of the medium is usually 6 to 8. The time for culturing in the above temperature range is not particularly limited, but is usually 20 hours to 50 hours.” (last paragraph of pg 4, and ending on pg 5 of the English translation).
Uchida teaches that the spores germinate and grow quickly while the environmental conditions are adjusted, seed culture (preliminary culture) does not need to be performed before lactic acid fermentation, and fermentation can be performed by adding a certain amount of stock spores. Uchida therefore teaches that through the use of the Bacillus sp. spores, it is possible to reduce the time required for seed culture, energy, equipment such as a preculture tank, and the like, thereby reducing costs and improving production speed (pg 5, paragraphs 5-6 of the English translation). Uchida teaches that the spores are resistant to drying, and the spores can be dried, powdered, and stored and transported, and that the use of such a dried and powdered product not only makes it easy to cope with large-scale culture, but also makes handling easier and reduces the cost of storing and transporting bacteria (pg 5, paragraphs 5-6 of the English translation).
Uchida demonstrates, in Example 2, that a seed solution comprising spores is added to a fermentation media with an office waste paper solution (after saccharification) and the seed, i.e. the spores, initiated the fermentation without a separate activation step (see Example 2, pgs. 8-9 of the English language translation).
Regarding the organic waste material, Uchida teaches that the provided biomass may include waste paper, wood, agricultural waste, specifically including as some examples: waste wood, waste wood residue, papermaking waste liquid, rice husk, soybean straw, straw, corn stalk, bagasse, and the like (pg 3, paragraphs 10-12). Uchida teaches that the biomass is preferably pretreated in advance for hydrolysis, and teaches pre-treatments wherein waste paper is cut, defibrated, and/or fiberized by dry method (i.e. grinded or pulverized) (on pg 3, paragraph 12). Thus Uchida teaches a pretreatment comprising reduction of the particle sizes.
“Tartu” pertains to obtaining and using endospores of sporogenous fermentable microorganisms, and is usable in microbiological production of lactic acid, where fermentation of sporogenous thermophilic fermentable microorganisms is initiated by an inoculum consisting of endospores (Abstract; page 1, lines 8-14). Tartu teaches a method of using the thermophilic sporogenous fermentable endospores to inoculate fermentation, wherein unimmobilized endospores of Bacillus coagulans are used for the inoculum (claims 5 and 6). In one example, Tartu provides a concentration of the inoculum of the endospores of 10^7 endospores per mL (see page 7, lines 15-17). Tartu also teaches that an inoculum consisting of endospores provides a significant advantage to production rate of lactic acid, wherein a culture based on endospores enables an almost 20% decrease in time of the production cycle, as compared to unsynchronized vegetative cells (see page 7, lines 22-28). Therefore, Tartu teaches that inoculation with spores of Bacillus coagulans is known in the art for initiating lactic acid fermentation.
Therefore, to one of ordinary skill in the art, before the effective filing date of the claimed invention, it would have been prima facie obvious to modify the simultaneous saccharification and fermentation method and system of Otto by selecting the model kitchen refuse taught in Sakai as the carbon source substrate and by incorporating dried spores of the bacteria, including dried spores of Bacillus coagulans as taught in Tartu, instead of the active bacteria used in Otto, for the predictable benefits suggested in Uchida and Sakai, including improving production speed, and it would have been obvious to provide a source of organic waste that had undergone a pretreatment step of size-reduction, as suggested in Otto and Sakai and taught in Uchida.
Sakai pertains to performing fermentation with organic wastes comprising a complex mixture of different kitchen and food wastes (fish residue, vegetables including carrot, potato and Chinese radish peel, fruit, including banana, apple and orange peel, cooked rice and green tea residue). Sakai teaches inoculating such complex waste with B. coagulans to yield high quality L-lactic acid, and determining optimal conditions (which fall within the ranges of claims 35 and 36). Sakai teaches that the use of these wastes for lactic acid production reduces the environmental impact of municipal food waste, can substitute for pure carbon sources (e.g. cornstarch), and may lower the production costs (pg 457, left col of Sakai).
One would have been motivated to provide dried spores of the inoculum, including Bacillus coagulans spores, because Uchida teaches that use of spores reduces the time required for seed culture, eliminates extra equipment such as a preculture tank, and reduces costs and improves production speed. Uchida further teaches that the dried spores can be easily stored and transported, and that the use of such a dried and powdered product makes handling easier and reduces the cost of storing and transporting bacteria. The cited teachings of Tartu demonstrate that the application of dried spores of Bacillus coagulans is known in the art for fermentation that produces lactic acid. Tartu teaches using viable endospores of B. coagulans with a step for activation and synchronization (pg. 7, lines 4-5, heating at 70°C for 30 minutes).
Yet, it is evident that there would have been a high level of skill in the art, and one having knowledge of the cited prior art would have been motivated to perform the inoculation with endospores for the benefits of the improved storage and reduced problems with transport. Further, the cited teachings of Sakai suggest that to one of ordinary skill in the art, the possibility of using B. coagulans would have been reasonably for the predictable benefits of improved storage (i.e. for “stocking and distribution”).
Regarding claim 35, Otto teaches that the pH, set for a compromise between the optimum pH of the enzyme and the optimum for Bacillus coagulans, was pH 5.65, and that the process was performed at pH 5-6 (see claim 5). Similarly, Sakai teaches performing the fermentation at pH 6.5 for the best L-lactic acid yield. Thus, the instantly claimed pH ranges would have been immediately obvious selections to one of ordinary skill.
Regarding claim 36, Otto teaches that a temperature was controlled at 54-56°C in an example, which is within the instantly claimed range. Other embodiments in Otto teach that the temperature range was found optimal between 55-70° C and Sakai teaches performing the fermentation at a temperature of at least 55° C. The instantly claimed temperature values would have been immediately obvious selections to one of ordinary skill.
In regards to claim 37, Otto teaches performing the process for 30-40 hours, while Sakai teaches high yields of L-lactic acid at 48 hrs is achievable with B. coagulans.
Regarding claims 38 and 39, the enzyme exemplified in Otto is glucoamylase, also known as γ-amylase, an enzyme belonging to the functional-class with the EC number 3.2.1.3. Thus one would have been motivated to use such an amylase for saccharification.
Regarding the concentration of the inoculated spores, Tartu teaches that a suitable and efficient inoculum was 10^7 endospores per milliliter, which is at least 10^4 as in the instant claim 40. Sakai teaches that 10^6 cells per milliliter of B. coagulans is a suitable amount of the inoculum. Regardless, one of ordinary skill in the art would have been motivated to optimize the concentration of spores added when performing the method made obvious by Otto in view of Sakai, Uchida and Tartu, as the concentration of an inoculum is a well-known result effective variable, and thus arriving at an optimum amount of spores to add would have been a case of routine optimization.
In regards to claim 41, Uchida teaches that Bacillus spores are dried, powdered, stored, and transported, and there is no reason to suggest that there is any significant moisture content to the dried and powdered spores. Regardless, the moisture content of the dried product would be subjected to many different factors including but not limited to, the relatively humidity, the storage vessel, and the handling of the powder. Further, the general level of knowledge in the art would motivate one to provide a low moisture powder, as low moisture content is crucial for maintaining the desired texture, preventing clumping, and preserving the spores. There is no evidence for any special results in the instant invention due to the particular moisture content.
Regarding claim 42, a system having all of the recited components for performing the method as presented in claim 29, made obvious by the combined teachings of Otto in view of Sakai, Tartu, and Uchida would have been prima facie obvious for the same reasons described for claim 29. Providing as a carbon source, a source of treated organic wase comprising mixed food waste would have been obvious to one of ordinary skill in view of Sakai, for the predictably benefit of utilizing waste material and lowering costs, as described above. Fermentation reactors, i.e. fermentation vessel or similar bioreactors, are used in each of the cited references for containing and mixing the media, carbon sources, enzymes, and bacterial cells. Thus, the providing of the claim system would have been well-known to one of skill in the art.
Regarding claim 49 (newly added), the claim recites essentially the same method as that of claim 29, without the saccharification steps happening simultaneously in step (iii). Both Sakai and Uchida teach pretreating the carbon source with a hydrolyzing enzyme, in order to provide a saccharified substrate, ready for fermentation. Sakai explicitly teaches adding a glucoamylase to the mixed kitchen refuse to yield a saccharified refuse extract. Thus, to one of ordinary skill in the art, the providing of saccharified pretreated organic waste when performing a method for producing lactic acid from organic waste with spores of B. coagulans would have been obvious in view of the cited teachings of Otto in view of Sakai, Tartu, and Uchida, for all of the benefits previously described. The art teaches that both pretreating a carbon source comprising organic waste with saccharifying enzymes and simultaneous saccharification of the waste with fermentation are known strategies in the art. The instant disclosure does not provide any evidence that this selection is critical and that one has a better performance than the other. Thus, the choice between these two methods (i.e. pretreatment of saccharification, as in claim 49, or simultaneous saccharification, as in claim 29) would have been a matter of judicious selection to one having ordinary skill in the art. Both would yield the expected result of fermenting the waste to yield lactic acid, as reasonably predicted from the cited teachings.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention, because Otto and Sakai each use B. coagulans inoculums with organic waste materials to make Lactic acid products and Sakai demonstrates using complex mixtures of food wastes for successful fermentation to yield lactic acid. Further, Uchida teaches efficient and successful fermentation when using dried Bacillus spores without any activation steps (in Example 2, on pages 8-9), while Tartu teaches that viable endospores of B. coagulans can successfully be revived and used for lactic acid fermentation.
Further, it is evident there is a high level of skill in the art of enzyme saccharification, fermentation, and lactic acid production including fermentation from organic wastes including the mixed kitchen wastes taught in Sakai.
Therefore, the invention as a whole would have been obvious to one of ordinary skill in the art, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 29-31, 35-39, and 41-43 are rejected under 35 U.S.C. 103 as being unpatentable over Otto (US Patent No. 8,119,376), “Sakai” (Journal of bioscience and bioengineering vol. 101,6 (2006): 457-63, termed herein after “Sakai”), “Uchida” (WO2005100543), and “Tartu” (WO2008043368, of record), as applied to claims 29, 35-39, and 41-42 above, and further in view of Baets et al. (US PGPub No. 20170218408), to include the rejections of claims 30, 31, and 43.
The combination of teachings of Otto, Sakai, Uchida, and Tartu make obvious a process and system for simultaneous saccharification and fermentation of pretreated organic waste using dried spores of Bacillus coagulans, for all of the reasons cited above.
The relevant teachings of Otto, Sakai, Uchida, and Tartu are set forth above.
However, the combination of Otto, Sakai, Uchida and Tartu does not teach a composition of dried spores suspended in a magnesium hydroxide slurry (as in claims 30-31 and claim 43).
Baets teaches a method for preparing a fermentation product lactic acid wherein the saccharification and the fermentation are carried out simultaneously, process including: b) saccharifying treated aqueous lignocellulosic material in the presence of a hydrolytic enzyme to provide a saccharified aqueous lignocellulosic material comprising fermentable carbohydrate and a solid lignocellulosic fraction; c) simultaneously with step b), fermenting the saccharified aqueous lignocellulosic material in the presence of both a lactic acid forming microorganism and caustic magnesium salt to provide an aqueous fermentation broth comprising magnesium lactate and a solid lignocellulosic fraction; and d) recovering magnesium lactate from the broth (Abstract, claim 1). Baets teaches that the caustic magnesium salt is selected from at least one of MgO, Mg(OH)2, MgCO3 and Mg (HCO3)2; the use of at least one of magnesium oxide and magnesium hydroxide in step a) is preferred ([0018]).
Baets specifically teaches “fermenting the saccharified aqueous lignocellulosic biomass in the presence of lactic acid forming microorganism and in the presence of a caustic magnesium salt to provide an aqueous fermentation broth comprising magnesium lactate and a solid lignocellulosic fraction; and, recovering magnesium lactate from the fermentation broth. Saccharification and fermentation steps are carried out simultaneously.” ([0064]). Baets then teaches that the fermentation medium is fermented by means of a lactic acid producing microorganism in the presence of a caustic magnesium salt to provide a fermentation broth containing magnesium lactate ([0073]).
Baets teaches that the adjustment of pH (in the reactor) is effected by a caustic magnesium salt preferably selected from MgO, Mg(OH)2, MgCO3, Mg(HCO3)2, because the caustic magnesium salt neutralizes the lactic acid excreted by the microorganisms during fermentation, thereby generating a magnesium lactate salt ([0079]).
In regards to claim 31, Baets teaches good results have been obtained where the reaction mixture has a concentration of caustic magnesium salt of from 5 to 25% (w/w) ([0057]).
It would have been prima facie obvious, to one of ordinary skill in the art before the effective filing date of the claimed invention, in light of all of the teachings of Baets and the general level of knowledge in the art, to have modified the method or system made obvious by the combined teachings of Otto in view of Sakai, Uchida and Tartu, to provide the B. coagulans spores with a magnesium hydroxide as a slurry when mixing the solutions in order to maintain the optimal pH level of the acid-producing reaction.
One would have been motivated to do so for the predictable benefits taught in Baets of neutralizing the lactic acid produced by the fermentation and thus resulting in the formation of a lactate salt, while also keeping the pH in the optimal range. The alkaline magnesium hydroxide is a recognized additive for such simultaneous saccharification and fermentation and thus an obvious choice to add to one or more of the components when performing the steps of providing the components for the reaction mixtures, and thus would also ultimately comprise a part of the combined structures comprising the system recited in claim 43.
Further, MPEP §2144.04 Subsection IV.C. describes that changes in sequence of adding ingredients is enumerated as one of the common practices which the courts have held normally require only ordinary skill in the art and hence are considered routine expedients. “See also In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results); In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.).”. Thus, the addition of the neutralizing alkaline Mg(OH)2 with the spore composition, i.e. the inoculum, and then the combination of all of the necessary parts for the simultaneous saccharification and fermentation method/system, would be prima facie obvious, in view of all of the cited teachings above.
The antimicrobial activity of a suitable concentration of alkaline magnesium hydroxide, used in the prior art at an overlapping concentration with the instantly claimed amounts, would intrinsically result in the functional activity of removing microbial contaminants, however many such methods of sterilization are known in the art, including such steps of harsh conditions through which spores can survive while living cells would not. Thus, in the absence of evidence of the criticality and/or unexpected results of the specific order of mixing in the magnesium hydroxide, the instant claims are found obvious over the combination of cited art.
From the teachings of Baets and the previously cited references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention, as the adjustment and buffering of the lactic acid fermentation is well-documented in the art, and the cited art teaches applying magnesium hydroxide for producing magnesium lactate salts in such a fermentation reaction.
Therefore, the invention as a whole would have been obvious to one of ordinary skill in the art, as evidenced by the references, especially in the absence of evidence to the contrary.
Allowable Subject Matter
Claims 32 and 33 are objected to as being dependent upon a rejected base claim, but would likely be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter, as presented in the previous Office action.
In claim 32, the recited step of prolonged incubation of a suspension comprising dried B. coagulans spores and a magnesium hydroxide slurry is not explicitly taught nor reasonably suggested in the relevant art.
Regarding claim 33, the relevant art does not teach nor reasonably suggest providing magnesium lactate with the dried composition of B. coagulans spores prior to any fermentation reaction occurring. Magnesium lactate is a known product that results from fermentation by lactic acid producing bacteria in the presence of magnesium ions, as taught in Baets et al. (US PGPub No. 20170218408). Inclusion of magnesium lactate with dried spores of B. coagulans, prior to the fermentation, as required by claim 33, is not taught nor suggested in the art.
Conclusion
Claims 29-31, 35-39, 41-43, and 49 are rejected herein.
Claims 32 and 33 are presently objected to but recite allowable subject matter.
Claims 46-48 are withdrawn.
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 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW TERRY MOEHLMAN whose telephone number is (571)270-0990. The examiner can normally be reached M-F 9am-5pm EST.
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/A.T.M./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655