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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 27, 2026 has been entered.
Claims 6, 21, 22, 31-33 and 41-43 have been cancelled. Claims 1-5, 8, 11, 12, 23-30, 34-40 and 44-51 are pending examination.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-5, 8, 11, 12, 23-30, 34-40 and 44-51 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1-3 require residual matter from a yeast; and cell lysate from a cell lysate of a bacteria engineered to express a mycotoxin-mitigating enzyme.
Paragraph [0067] provides the support to claim that two different microorganisms can be used in the process of making the claimed livestock feed. The disclosure says genes encoding the mycotoxin mitigating enzyme can be engineered into a separate microorganism, e.g., yeast or bacteria (i.e., a second microorganism), that is co-fermented with the production yeast (i.e., a first microorganism).
The specification does not provide support to claim the livestock feed comprises residual matter from the yeast or residual matter from a cell lysate of the bacteria. The specification says the fermentation product is distilled and dehydrated to recover ethanol and that the “residual matter” comprising water, soluble components, oil, and unfermented solids that can be further processed to separate out desirable fermentation by-products, for example dried distillers’ grains, mash, beer, whole stillage, thin stillage, wet caked, syrup, etc., used for animal feed ([0061]). . There is nothing in the disclosure that defines what “residual matter” from a yeast or a bacteria embodies. Is the residual matter from the yeast or the bacteria considered the unfermented solids?
Claim 48 requires (a) residual matter comprising amino acids from the yeast; and (b) residual matter comprising amino acids from the bacteria. In this case, while there is support to claim the microorganism (e.g., bacteria) expressing mycotoxin mitigating enzyme may add to the amino acid profile of the protein in an animal feed, there is no support in the specification to claim what the residual matter comprising amino acids from yeast and bacteria encompasses or that that the amino acids contribute to the amino acid profiles of the protein in livestock feed. For example, what amino acid profile would meet the limitations of “residual matter comprising amino acids from the yeast? If there is one type of amino acid found in the livestock feed, would the limitation of claim 48 be satisfied?
Claims 4, 5, 8, 11, 12, 23-30, 34-40, 44-47 and 49-51 are rejected because they are dependent from a base claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 1-5, 8, 11, 12, 23-30, 34-40 and 44-51 are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al. (CN-102827881-Machine Translation).
Regarding claims 1-4, 8, 24, 25, 27, 28, 35, 37, 38 and 45-51, Wu et al. discloses when grains contaminated with mycotoxins are used to produce ethanol, the toxins are concentrated in a large number of by-products such as distiller’s grain obtained from fermentation. These distiller’s contain mycotoxins such deoxynivalenol (DON), zearalenone (ZEN) and fumonisin (FUM) [0006].
Wu et al. disclose engineered bacteria with suzyme gene can effectively degrade the mycotoxins in the fermentation product while producing the fermentation product ([0008]). Wu et al. discloses the genes and the resulting enzymes for degrading mycotoxins [0021].
Wu et al. discloses that contaminated grains are fermented using Saccharomyces cerevisiae strains containing mycotoxin-degrading enzyme genes. Such enzyme genes may be zearalenone degrading enzyme genes, deoxynivalenol degrading enzyme genes and fumonisin degrading enzyme gene [0014].
Wu et al. discloses an experiment wherein a mycotoxin- contaminated wheat is used as the raw material [0068]. The yeast used comprises three genes for ZEN, DON, and FUM degradation [0071]. The mycotoxin content of DDGS after fermentation is determined. Wu et al. disclose that the mycotoxin contaminated wheat comprised 725 µg/kg ZEN, 2560 µg/kg DON and 1453 µg/kg FUM ([0068]. Wu et al. discloses changes of mycotoxin content in distiller’s dried grains soluble (DDGS) in ethanol fermentation [0028]. Specifically, Wu et al. discloses that the degradation rate for ZEN is 97%, for DON is 94% and for FUM is 93% [0080]. Therefore, the distillers grain of Wu et al. would comprise less than 2 ppm mycotoxin (wherein 1 ppm = 1000 µg/kg).
While Wu et al. disclose mycotoxin mitigating enzymes derived from the same microorganism used to generate the distiller’s grain, given claims 1-3 are directed to a livestock feed composition with a reduced level of mycotoxins and not a method of producing livestock feed composition, the patentability of a product does not depend on its method of production if the product in the product-by-process claim is the same as or obvious from a product of the prior art (MPEP §2133). Here, Wu et al. clearly disclose livestock feed compositions comprising distiller’s grain having low levels of mycotoxins. Moreover, given Wu et al. disclose a microorganism, Saccharomyces cerevisiae, containing mycotoxin-degrading enzyme genes that are used to ferment the distillers grain, inherently the livestock feed would comprise residual content, including amino acids from the yeast. Given claims 1, 3 and 48 do not require that the residual content have specific components or specific ratios of amino acids, the livestock feed composition of Wu et al. comprising distiller’s grain and having low levels of mycotoxins, would be considered to have the disclosed residual matter.
Regarding claims 5, 11, 12, 26, 29, 30, 36, 39 and 40. Wu et al. disclose all of the claim limitations as set forth above. Wu et al. discloses Saccharomyces cerevisiae strains containing mycotoxin-degrading enzyme genes wherein the enzyme genes can be zearalenone degrading enzyme genes, deoxynivalenol degrading enzyme genes and fumonisin degrading enzyme gene [0014].
While Wu et al. does not explicitly disclose the claimed enzymes, Wu et al. clearly disclose yeast strains engineered to exhibit the action of for example deoxynivalenol hydroxylase, a deoxynivalenol degrading enzyme or zearalenone hydrolase, a zearalenone degrading enzyme.
Regarding claims 23, 34 and 44, Wu et al. disclose all of the claim limitations as set forth above. Wu et al. disclose engineered bacteria with suzyme gene can effectively degrade the mycotoxins in the fermentation product while producing the fermentation product (i.e., producing ethanol -[0008]). Wu et al. discloses Saccharomyces cerevisiae strains containing mycotoxin-degrading enzyme genes wherein the enzyme genes can be zearalenone degrading enzyme genes, deoxynivalenol degrading enzyme genes and fumonisin degrading enzyme gene [0014].
While Wu et al. does not disclose bacterium, given Wu et al. disclose a composition comprising distiller’s grain having low levels of mycotoxins, the fact that the mycotoxin is reduced using an engineered yeast rather than a bacterium is not determinative of patentability. The patentability of a composition does not depend on its method of production if the product in the product-by-process claim is the same as or obvious from the product (MPEP §2113).
Response to Arguments
Applicant's arguments filed January 27, 2026 have been fully considered but they are not persuasive.
Rejection under 35 U.S.C. 112 (a) –
Applicant submits “[b]y necessity, the soluble components and unfermented solids would comprise (i) residual matter of the ground grain feedstock (or post-fermentation stillage, wet cake, and/or syrup stream or the deer [sic]); (ii) residual matter from the yeast; and (iii) residual matter from the bacteria, or the cell lysate of the bacteria, or the cell lysate of the bacteria.” soluble components and unfermented solids would comprise amino acids from the yeast and bacteria. Likewise, the soluble components and unfermented solids would comprise amino acids from the yeast and the bacteria.” Applicant notes paragraph [0063] of the specification which states the microorganism may add to the amino acid profile of the protein in the animal feed.
Here, the present specification states “residual matter” comprises water, soluble components, oil, and unfermented solids. The present specification also states the “residual matter” can be further processed to separate out desirable fermentation by-products, for example dried distillers’ grains with solubles , mash, beer, whole stillage, thin stillage, wet cake, syrup, etc. used for animal feed. The specification does not consider what is in the soluble components or unfermented solids. If constituents of the yeast and bacteria are indeed part of the disclosed “residual matter” identity of those constituents are unknown. Does the “residual matter” of the yeast include, for example amino acids? Are the amino acids discernable from amino acids from a bacteria or grain feedstock?
Rejection under 35 U.S.C. 103-
Applicant explains Wu et al. mentions a single engineered yeast strain that both produces ethanol and enzymes that degrade mycotoxin” and “fails to teach or suggest the residual elements of claims 1-3. Applicant argues “Wu et al. neither teach nor suggest a livestock feed composition comprising residual matter from both a yeast and a bacteria.”
While Wu et al. disclose mycotoxin mitigating enzymes derived from the same microorganism used to generate the distiller’s grain, given claims 1-3 are directed to a livestock feed composition with a reduced level of mycotoxins and not a method of producing livestock feed composition, the patentability of a product does not depend on its method of production if the product in the product-by-process claim is the same as or obvious from a product of the prior art (MPEP §2133). Here, Wu et al. clearly disclose livestock feed compositions comprising distiller’s grain having low levels of mycotoxins. Moreover, given Wu et al. disclose a microorganism, Saccharomyces cerevisiae, containing mycotoxin-degrading enzyme genes that are used to ferment the distillers grain, inherently the livestock feed would comprise residual content, including amino acids from the yeast. Given claims 1, 3 and 48 do not require that the residual content have specific components or specific ratios of amino acids, the livestock feed composition of Wu et al. comprising distiller’s grain and having low levels of mycotoxins, would be considered to have the disclosed residual matter. There is no evidence on the record demonstrating a material difference between the claimed livestock feed composition and that disclosed by Wu et al.
Conclusion
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ELIZABETH A. GWARTNEY
Primary Examiner
Art Unit 1759
/ELIZABETH GWARTNEY/Primary Examiner, Art Unit 1759