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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/05/2025 has been entered.
Claim Status
The amendment of 12/05/2025 has been entered. Claims 71-72, 74-78, 80-82, 84-85, 87, and 90-104 are currently pending in this US patent application and were examined on their merits.
Claim Interpretation
The preambles of independent claims 71, 81, and 94 recite a method of increasing propagation or fermentation of a desirable microorganism, a method of reducing glycerol production in a fermentation mixture, and a method of improving yeast vitality, respectively. Claim 99 recites the intended result of practicing the method of claim 71. MPEP § 2111.04 states that a clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited. MPEP § 2111.02 (II) states that, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. The Examiner notes that the preamble merely states the intended use of the recited method, which is fully and intrinsically set forth in the body of claims 71, 81, and 94. As such, any prior art method that performs the steps of claims 71, 81, and 94 will be interpreted to read on the entireties of claims 71, 81, and 94, respectively. Similarly, any prior art that reads on claim 71 will be interpreted to read on claim 99 as well.
Claim Objections
Claims 75-77, 85, 90, 93, and 95-96 are objected to because of the following informalities:
The claim status identifiers for these claims in the amendment of 12/05/2025 is “withdrawn.” The “withdrawn” claim status applies to claims that are currently not under examination as a result of a restriction requirement. No restriction requirement has been made in the instant application. As such, all pending claims are currently under examination, making the “withdrawn” status identifier inappropriate.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 95-96 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 95-96 depend from claim 94 and recite limitations of “the fermentation product;” claim 95 further recites “and/or the byproducts.” Claim 94 does not recite a fermentation product or a byproduct. As such, claims 95-96 lack clear antecedent basis to the claim from which they depend, which causes confusion because it is unclear which step of claim 94 is to be further limited by limitations of “the fermentation product” or “the byproducts.” Accordingly, one of ordinary skill in the art would be unable to determine the metes and bounds of claims 95-96, rendering them indefinite, and claims 95-96 are rejected under 35 U.S.C. 112(b).
In the interest of compact prosecution, the Examiner has interpreted claims 95 and 96 to state that the mixture of claim 94 is distilled to produce a fermentation product and/or byproducts, followed by the specific limitations of claims 95-96.
Claim Rejections - 35 U.S.C. § 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 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 71-72, 74-78, 80-82, 84-85, 87, 90, 92, 94, and 96-104 are rejected under 35 U.S.C. § 103 as being unpatentable over US patent 8772002 filed by Chapman et al., issued 07/08/2014, in view of US patent application 2010/0324137 filed by Coughlin, published 12/23/2010.
Regarding claims 71, 81, 94, 99, and 103 (see above under Claim Interpretation for the Examiner’s interpretation of claim 99, which recites the intended result of the process of claim 71), Chapman teaches that during the propagation, conditioning or fermentation process, the mash or the fermentation mixture can become contaminated with other microorganisms, such as spoilage bacteria where such microorganisms compete with the desired species of yeast for fermentable sugars and retard the desired bio-chemical reaction resulting in a lower product yield and also produce unwanted chemical by-products, which can cause spoilage of entire fermentation batches (column 2, lines 12-19; i.e., initial levels contaminating microorganism can propagate and then cause spoilage to the fermentation). During any of these three processes, the yeast can become contaminated with undesirable yeast, bacteria or other undesirable microorganisms, where this can occur in one of the many vessels used in propagation, conditioning or fermentation (e.g., propagation tanks, conditioning tanks, starter tanks, fermentation tanks, and piping and heat exchanger; column 2, lines 29-35).
As noted by Chapman, although antibiotics can be utilized in the process to address contamination by undesirable microorganisms, antibiotics are expensive, can add greatly to the costs of large-scale production, and are not effective against all strains of bacteria, such as antibiotic-resistant strains of bacteria, where overuse of antibiotics can lead to the creation of additional variants of antibiotic-resistant strains of bacteria (column 3, lines 23-30). Chapman also teaches that antibiotic residues and establishment of antibiotic-resistant strains is a concern with regard to distiller’s grains that are used for animal feed (column 3, lines 31-35). Distiller’s grain is the grain residue of the fermentation process, where byproducts of an ethanol plant (i.e., distiller’s grain) are not allowed to be sold as animal feed if antibiotics are used in the facility (column 3, lines 35-38).
In view of the above, Chapman teaches that, as part of the fermentation process, distiller’s grain is a grain product produced during the fermentation process. If the mash or the fermentation mixture can become contaminated with other microorganisms, such as spoilage bacteria, where such microorganisms compete with the desired species of yeast for fermentable sugars and can cause spoilage of entire fermentation batches (column 2, lines 12-19), the distiller’s grain can also be contaminated with spoilage bacteria, where initial levels contaminating microorganism can propagate during the fermentation process and be carried along with the distiller’s grain, which would make the grain product unusable as a feed product.
Chapman additionally teaches that reducing the concentration of contaminating microorganisms will encourage yeast propagation and/or conditioning and increase yeast efficiency, making it possible to attain and exceed ethanol production yields (column 2, lines 36-45). In view of the above, this will also provide a benefit of producing distiller’s grain as a feed product free from contaminating (spoilage) microorganisms.
Chapman teaches that organic acids have many applications, including being used as acidifiers, buffers, synergists, and antimicrobials, as well as used as preservatives because of their effect on bacteria (column 3, lines 63-68). Antimicrobials are used to eliminate, reduce or otherwise control the number of microbes in aqueous systems (column 4, lines 12-15).
Regarding claims 71, 81, and 94, Chapman teaches methods for controlling undesirable microorganism concentration in an aqueous solution employed in a fermentation process (column 4, line 59, to column 5, line 13; Chapman claims 1 and 9). The methods teach the use of antimicrobial compounds within the fermentation process for improved antimicrobial efficacy and for improved results in the production of final products (e.g., cellulosic ethanol, distiller’s grain; column 3, lines 35-38, column 7, lines 2-4; column 8, lines 1-3). Specifically, the method comprises the steps of: (a) introducing a fermentable carbohydrate to the aqueous system; (b) introducing at least one desirable microorganism that is capable of fermenting the fermentable carbohydrate to the aqueous system; (c) introducing at least one hops acid extract into the aqueous system; and (d) introducing at least one organic acid into the aqueous system; wherein the organic acid is citric acid or its salts. Through the use of hops acid and organic acid, less or no antibiotic can be used in the fermentation process (Chapman claims 1, 3, 9 and 11; column 5, line 1, to column 6, line 2; cf. instant claim 72; cf. instant claim 71, lines 1-10, and instant claim 81, lines 1-9; the Examiner notes that using no antibiotic in the fermentation process, as suggested by Chapman, would intrinsically result in a fermentation system, fermentation mixture, fermentation product, and byproducts that are “substantially free of antibiotics” as recited in instant claims 71, 81, 94, 97-98, and 102).
Chapman also teaches that other fermentation products could employ the combination of hops acids and organic acids (e.g., citric acid) could include distilled spirits, beer, wine, pharmaceuticals, pharmaceutical intermediates, baking products, nutraceuticals, industrial chemical feedstocks, and enzymes (column 7, lines 5-15).
With regard to the amount of organic acids, Chapman teaches that the addition of hops acid extracts in conjunction with the addition of organic acids results in improved antimicrobial efficacy (column 7, lines 2-4; cf. claims 72 and 82).
The hops acid and organic acid can be added at various points in the propagation, conditioning and/or fermentation processes (column 7, lines 31-33). The hops acids and the organic acids can be added sequentially or separately to the system to be treated (column 9, lines 51-53). The organic acid can be added to cook vessels, fermentation tanks, propagation tanks, conditioning tanks, starter tanks or during liquefaction or added directly to the corn mash (column 7, lines 33-37).
The organic acid can be added directly into the fermentation mixture (cereal grains such as corn or wheat or materials such as distiller’s grains; columns 1, lines 64-67, column 2, line 20, column 3, lines 34-36; Example 4) by adding the organic acid in conjunction with the yeast or other desirable microorganism and fermentable carbohydrate (column 7, lines 41-45; cf. instant claims 71, 74, 81, 84, and 94).
Further, Chapman teaches that the organic acid is introduced into the fermentation at a temperature of 32°C (Example 3, column 13, lines 3-8).
Regarding instant claims 76-78 and 81, Chapman teaches that hops acid extract dosages are least 0.5 ppm and less than 120 ppm and the organic acid dosages is between 100 and 2000 ppm or greater, which can be added directly into the fermentation mixture (column 7, lines 47-55; claims 12, 13, 15 and 16; column 6, lines 60-66; i.e., the above are the at least one acid at the claimed concentrations). That is, with regard to the amount of organic acid is 100 and 2000 ppm or greater, such amounts of acid are applied to the cellulosic material such as corn, wheat, or distiller’s grain. Further, Chapman teaches that the amount of organic acid can be used in amounts of from 12500 ppm down to 100 ppm that is applied to the cellulosic material (e.g., such as corn, wheat, or distiller’s grain; column 1, lines 64-67, column 2, line 20, column 3, lines 34-36; Example 4; column 9, lines 58-59). Chapman further teaches that a person of ordinary skill in the art using the described teachings can determine the concentration of the composition required to achieve acceptable microbial control, and that the concentration is dependent on the matrix (column 10, lines 14-17). In view of the above, Chapman teaches that the organic acid can be applied to the cellulosic material within the fermentation (e.g., distiller’s grain), which encompasses the ranges of the amounts of acid within claims 76-78 and 86-88.
Regarding the steps recited in lines 7-10 of claim 81, Chapman teaches embodiments in which slurries comprising corn flour that were inoculated with Saccharomyces cerevisiae and fermented to produce ethanol were then subjected to centrifugation to remove solids, filtered, and submitted to HPLC testing (column 12, line 34, to column 13, line 22; cf. claims 92 and 96). The step of centrifugation constitutes “separating ethanol from whole stillage byproducts of fermentation and distillation processes” recited in claim 81. The container holding the solids and ethanol post-centrifugation can be interpreted as “storing the separated ethanol, whereby the separated ethanol is substantially free of man-made antibiotics”. Chapman also teaches that ethanol is recovered from fermentation processes by distillation (column 8, lines 53-55; cf. claim 71 [“…distilling and separating a fermentation product from one or more byproducts”])
Regarding claims 74 and 84, Chapman teaches that the desirable microorganism is selected from the group consisting of a yeast, a fungus, a bacteria, or combinations thereof (claim 17; column 7, lines 17-30).
Regarding claims 75 and 85, Chapman teaches that the steps are performed sequentially (claim 10; column 5, lines 29-51).
However, although Chapman teaches methods for controlling undesirable microorganism concentration in an aqueous solution employed in a fermentation process and indicates the amounts of organic acids that can be utilized that fall within the range of instant claim 1, Chapman does not teach introducing at least one ethyl lauroyl arginate compound into the aqueous system.
Regarding instant claims 71, 80-81, 90, and 94, Coughlin teaches lauric arginate as a contact antimicrobial and a food preservative (see entire document, including title and page 1, paragraph 0002). Coughlin teaches that an antimicrobial effect of lauric arginate can be enhanced by the addition of one of more compounds which includes citric acid (paragraph 3). The composition of Coughlin is also known as ethyl lauroyl arginate or lauric arginate ethyl ester (page 1, paragraph 0006). Coughlin teaches that the LAE-citric acid composition can be used as a contact antimicrobial, in particular to kill bacteria on surfaces and can be incorporated into a surface cleaning composition (paragraph 4). Coughlin teaches that lauric arginate ethyl ester (LAE) is combined with a second component (e.g., citric acid) to provide an aqueous disinfecting (antimicrobial) solution which is applied to a surface to disinfect the surface (paragraphs 6 and 7). Coughlin teaches that LAE is commercially available as a water-soluble powder and is combined with one of the second components (e.g., citric acid), and dissolved in water to form a disinfecting (antimicrobial) solution (paragraph 8).
Regarding instant claims 71, 80-81, 90, 94, 100-101, and 104, Coughlin also teaches LAE compounds where the concentration of LAE will be 5 ppm up to about 50 ppm (paragraph 9). With respect to the citric acid, when it is used with respect to the LAE, the use concentration of LAE will be 40 to 400 ppm (paragraph 9). Further, Coughlin teaches that the ratio of LAE to citric acid will vary from 1:10 to 10:1 by weight (paragraph 8).
Coughlin teaches that the antimicrobial aqueous solution is applied to a surface by any well-known manner (e.g., spraying, immersion, etc.) and can be used for a wide variety of antimicrobial disinfecting applications (paragraph 14).
While Chapman does not teach the inclusion of ethyl lauroyl arginate in the fermentation broth, one of ordinary skill in the art would have been motivated to add the LAE-citric acid antimicrobial composition of Coughlin to the antimicrobial composition of Chapman (at the dosing described in Chapman) because both references teach the use of overlapping antimicrobial compositions for controlling undesirable microorganisms. Chapman teaches methods for controlling contamination from undesirable microorganism in fermentations, which include fermentations to produce ethanol and fermentations within the food industry, while Coughlin teaches that LAE compositions provide an aqueous disinfecting (antimicrobial) solution that is commercially available and combined with citric acid and water to form a contact disinfecting antimicrobial solution that can be applied to a surface by any well-known manner (e.g., immersion, etc.) and can be used for a wide variety of antimicrobial disinfecting applications.
A person of ordinary skill in the art would have had a reasonable expectation of success in adding the LAE-citric acid antimicrobial composition of Coughlin to the antimicrobial composition of Chapman (at the dosing described in Chapman) because doing so would provide an advantage to the Chapman method by providing an expanded, broader spectrum composition or alternative antimicrobial composition that inhibits undesirable microorganisms in fermentation processes without the use of antibiotics and increases production yields while preserving grain product (i.e., distiller’s grain, which is the grain residue of the fermentation process) produced during fermentation.
It is submitted that, based on the above, the use of antimicrobial compositions to control undesirable microorganisms in fermentation processes, food-based processes, and food-based fermentation processes is well known in the art. It would further have been obvious to one having ordinary skill in the art to combine the methodologies taught within Chapman (i.e., methods for controlling undesirable microorganisms in a fermentation processes that introduces a fermentable carbohydrate, at least one desirable microorganism which is capable of fermenting carbohydrates, at least one hops acid extract and organic acid into the aqueous system at the desired dosages within Chapman) with the methodologies in Coughlin (i.e., utilizing lauric arginate-citric acid compositions as a contact antimicrobial) for the purpose of maximizing the benefits of known antimicrobial compositions to control undesirable microorganism contamination of fermentation processes and increase production yields while preserving grain product (such as distiller’s grain) produced during fermentation.
Combinations of multiple products (i.e., antimicrobial compositions for fermentation processes, food-based processes, and food-based fermentation processes that include organic acids as well as contact antimicrobial compositions such as LAE and citric acid and methods to minimize undesirable contaminating microorganisms utilizing such compositions) each known to have the same effect (i.e., antimicrobial and preservative activities against undesirable contaminating microorganisms) to produce a final product (process where there are less contaminating microorganisms present for the fermentation and subsequent downstream grain products such as distiller’s grain) having the same effect (i.e., inhibited or diminished amounts of contaminating microorganisms so that yield production increases and less clean up in the process, while preserving grain product produced during fermentation) is prima facie obvious. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose....[T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850,205 USPQ 1069, 1072 (CCPA 1980) (citations omitted; MPEP2144.06).
With regard to the concentration ranges and ratios of the acid and the LAE compounds within claims 71, 76-78, 80-81, 87, 90, and 94, it would have been within the purview of one of ordinary skill in the art to utilize the combined teachings of Chapman and Coughlin and utilize the LAE compounds within the Chapman methods at the indicated amounts as discussed in Chapman since both Chapman and Coughlin teach the amounts of compounds that can be used to control undesirable microorganisms by utilizing organic acids at the dosages described in Chapman.
As noted above, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP § 2144.05(II)(A).
It is additionally noted that with regard to the order of steps, the instant claims have the transitional phrase “comprising,” which is inclusive or open-ended and does not exclude additional, unrecited elements or method steps (MPEP § 2111.03).
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Therefore, claims 71-72, 74-78, 80-82, 84-85, 87, 90, 92, 94, and 96-104 are rendered obvious by Chapman in view of Coughlin and are rejected under 35 U.S.C. 103.
The Supreme Court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation…103 likely bars its patentability…if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions……the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) (emphasis added).
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. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Allowable Subject Matter
Claims 91 and 93 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The closest prior art to claims 91 and 93 is found in Chapman and Coughlin, as discussed above. However, these references do not teach or suggest the subsequent addition of a second ethyl lauroyl arginate compound to the fermentation product/ethanol and/or to the byproducts following the separation/distillation of the ethanol produced in fermentation. As such, these claims are free of the prior art but are objected to because they depend from rejected base claims. Please note that claim 95 also recites this subject matter, but claim 95 is currently rejected under 35 U.S.C. 112(b) as a result of the amendment of 12/05/2025.
Response to Arguments
Applicant has traversed the above rejection of the claims under 35 USC 103 as being unpatentable over Chapman in view of Coughlin. Applicant states Coughlin teaches the use of ELA as a contact antimicrobial which kills all microorganisms, which Applicant states would be incompatible with Applicant’s aqueous fermentation using ELA to prevent the growth of undesirable microorganisms. Applicant states that, accordingly, one of ordinary skill in the art would not have been motivated to combine Chapman and Coughlin (remarks, pages 8-9). This argument has been fully considered but has not been found persuasive.
The Examiner notes that, contrary to Applicant’s assertion, Coughlin also teaches the use of ELA as a food preservative (Coughlin page 1, paragraph 0002) and that it is used to kill bacteria (page 1, paragraph 0004). The only microbial species that Coughlin shows is affected by ELA is E. coli (page 1, paragraph 0018). At no point does Coughlin suggest that ELA kills “all microorganisms,” as asserted by Applicant. Given that Chapman’s fermentation process uses yeast and that Chapman cites particular challenges associated with the presence of spoilage bacteria in the fermentation mixture (see citations above), the Examiner does not agree that one of ordinary skill in the art would not be motivated to combine Coughlin’s teaching of a food preservative compound that kills bacteria with the fermentation process of Chapman.
Applicant cites the Declaration of Allen Ziegler, submitted in the parent case 15/558700, to state that choosing an antimicrobial for a fermentation process is complex and includes factors that cannot be reasonably predicted. Applicant states that the Declaration notes that ELA improves the health of the yeast, which Applicant states is an unexpected result (remarks, page 9). This argument has been fully considered but has not been found persuasive.
The Examiner notes that a declaration filed in another application cannot be applied to the instant application. The Examiner further notes that the use of ELA in fermentation processes is suggested by the combination of Chapman and Coughlin, which is sufficient for prima facie obviousness. A finding of obviousness requires only a reasonable expectation of success, not an absolute certainty of success. The Examiner further notes that Chapman discusses the effect of antibiotic use on yeast stress, indicating that overusing antibiotics can stress yeast and impact efficiency (Chapman column 3, lines 50-52). As such, the Examiner does not concur that it would be unexpected to one of ordinary skill in the art that yeast would exhibit less stress in a fermentation process using ELA instead of a traditional antibiotic.
Therefore, the Examiner has maintained the rejections presented above.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Erin M. Bowers, whose telephone number is (571)272-2897. The examiner can normally be reached Monday-Friday, 7:30-5:00.
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/Erin M. Bowers/Primary Examiner, Art Unit 1653 01/08/2026