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 .
In view of the Appeal Brief filed on 8/26/25, PROSECUTION IS HEREBY REOPENED. New grounds of rejection are set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
Status of the Claims
Claims 1-19 are pending and have been examined on the merits
Withdrawn Rejections
The 103(a) rejections of claims 1-4, 12, 13, 14, 15, 17 and 18 over Kinley et al. (US 2005/0136520) in view of Reppas et al. (WO 2012/071547) have been withdrawn.
The 103(a) rejection of claim 5 over Kinley et al. (US 2005/0136520) in view of Reppas et al. (WO 2012/ 071547) and in further view of Blotsky et al. (US 2014/0030228) and Tanaka et al. (US 2007/0020250) has been withdrawn.
The 103(a) rejection of claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Kinley et al. (US 2005/0136520) in view of Reppas et al. (WO 2012/ 071547) and in further view of Medoff (US 2010/0124583) and De Vos et al. (EP 0228726) has been withdrawn.
The 103(a) rejection of claim 7 over Kinley et al. (US 2005/0136520) in view of Reppas et al. (WO 2012/ 071547) and in further view of Blank et al. (US 2002/0034815) has been withdrawn.
The 103(a) rejections of claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Kinley et al. (US 2005/0136520) in view of Reppas et al. (WO 2012/ 071547) and in further view of Turano et al. (US 2009/0077693) have been withdrawn.
The 103 (a) rejection of claim 11 over Kinley et al. (US 2005/0136520) in view of Reppas et al. (WO 2012/ 071547) and in further view of Medoff (AU 2014/256919) has been withdrawn.
The 103(a) rejections of claims 16 and 19 over Kinley et al. (US 2005/0136520) in view of Reppas et al. (WO 2012/071547) and in further view of Borst et al. (US 20190185885) have been withdrawn.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-4, 12, 13, 14, 15, 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Kinley et al. (US 2005/0136520) in view of Reppas et al. (WO 2012/071547) and Dysvik et al. Co-fermentation Involving Saccharomyces cerevisiae and Lactobacillus Species Tolerant to Brewing-Related Stress…” Frontiers in Microbiology February 2020 vol. 11.
Regarding Claims 1 and 13: Kinley discloses subjecting a biomass to fermentation in the presence of microorganisms including lactic acid bacterium and yeasts [0008; 0065; 0117; 0118]. Kinley discloses that the microorganisms can be recombinant microorganisms [0008; 0038]. Kinley discloses the formation of residuals (whole stillage) and ethanol (fermentation product) and that the ethanol is separated in the distillation and dehydration steps [0074-0075].
Kinley does not disclose that the recombinant bacteria is lactic acid bacteria.
Kinley does not disclose contacting the biomass with both a lactic acid bacteria and a yeast.
Kinley does not disclose wherein the recombinant LAB host cell is capable of expressing one or more first heterologous enzyme for converting the biomass into the fermentation product; and wherein the whole stillage obtained after step (b) has a different nutritional content than a control whole stillage submitted to step (a) in the absence of the recombinant LAB host cell.
Reppas discloses recombinant lactic acid bacteria and recombinant yeast [0019; 00105; 00106]. Reppas discloses using the recombinant lactic acid bacteria and recombinant yeast to ferment a biomass [00138]. Reppas discloses that the recombinant microorganism is able to express one or more heterologous enzymes [0007-0009; 0021].
Dysvik discloses the co-fermentation of Lactobacillus sp. and Saccharomyces sp. [abstract]. Dysvik discloses the production of alcohol from the co-fermentation process [abstract]. Dysvik discloses the Lactobacilli as able to withstand the stress of low pH, the presence of ethanol, and hops (has anti-microbial properties) [abstract]. Dysvik discloses fermentation with different species of lactobacilli resulted in beer with varying but desirable flavor attributes [abstract]. Dysvik discloses
“lactobacilli seemingly produced g-aminobutyric acid (GABA), as this amino acid accumulated in the co-fermented beers (Table 1)” [pg. 9]. Dysvik discloses “Overall, these data suggest that lactobacilli influenced the beer fermentation in different ways. While L. plantarum contributes to the fermentation by depleting amino acids and carbohydrates quickly, its presence did not disrupt the yeast fermentation extensively, as the final ethanol concentration and ADF are similar to the reference beer.” [pg. 9]. Dysvik acknowledges a difference in fermentation products from yeast and lactic acid co-fermentation versus yeast alone/reference beer.
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the method of Kinley to include recombinant LAB as in Reppas since Kinley discloses the use of recombinant bacteria as generally useful in the production of fermented products from biomass and since Reppas also utilized recombinant LAB in the formation of a biomass.
Further it would have been obvious to modify the method of Kinley to utilize both yeast and LAB as in Dysvik since Dysvik discloses that lactobacilli and yeast can be co-fermented to produce ethanol/ sour beer.
Further since, Dysvik discloses that the presence of lactobacilli co-fermented with yeasts produces differing amino acids and more consumption of carbohydrates this indicates a difference in the nutritional content of whole stillage.
However, since Kinley as modified uses the same process and LAB and yeast as recited, it would have been obvious that the whole stillage disclosed in Kinley would have exhibited the same features as presently recited. “products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Regarding Claim 2: Kinley as modified discloses as discussed above in claim 1. Kinley does not disclose wherein the whole stillage has, when compared to the control whole stillage: an increase in protein content; a different amino acid profile; an increase in fiber content; an increase in lipid content; and/or when the biomass comprises starch, a decrease in starch content.
However, since Kinley as modified uses the same process and LAB and yeast as recited, it would have been obvious that the whole stillage disclosed in Kinley would have exhibited the same features as presently recited. “products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Further since, Dysvik discloses that the presence of lactobacilli co-fermented with yeasts produces differing amino acids and more consumption of carbohydrates this indicates a difference in the nutritional content of whole stillage.
Regarding Claim 3: Kinley as modified discloses as discussed above in claim 1. Kinley discloses that the biomass can be derived from corn and that the product can be ethanol [0039, 0040; 0042; 0045].
Regarding Claim 4: Kinley as modified discloses as discussed above in claim 1. Kinley does not disclose that the one or more first heterologous enzyme comprises a polypeptide having pyruvate decarboxylase activity and/or a polypeptide having alcohol dehydrogenase activity and the recombinant LAB host cell has a decreased lactate dehydrogenase activity when compared to a corresponding native LAB host cell.
Reppas discloses that the LAB host cell comprises pyruvate decarboxylase and/or alcohol dehydrogenase and a decreased lactate dehydrogenase [0021; 0039; 0041; 00148; claim 19]. Reppas discloses attenuated lactate dehydrogenase [0042; 0071; claim 22].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art that the LAB of modified Kinley would have had pyruvate decarboxylase and/or alcohol dehydrogenase and a decreased lactate dehydrogenase as it is a feature of the LAB of Reppas.
Regarding Claim 12: Kinley as modified discloses as discussed above in claim 1. Kinley discloses that the yeast can be recombinant yeast from S. cerevisiae [0008].
Regarding Claim 14: Kinley as modified discloses as discussed above in claim 1. Kinley discloses centrifuging to separate the whole stillage and the thin stillage [0075].
Regarding Claim 15: Kinley as modified discloses as discussed above in claim 1. Kinley discloses evaporating thin stillage to obtain a molasses/syrup [Figs. 4 and 5; 0076].
Regarding Claim 17: Kinley as modified discloses as discussed above in claim 1. Kinley discloses whole stillage obtained by the process of claim 1 which as modified comprises a recombinant host LAB [Figs. 4 and 5; 0076].
Regarding Claim 18: Kinley as modified discloses as discussed above in claim 15. Kinley discloses syrup obtained by the process of claim 15 which as modified comprises a recombinant host LAB [Figs. 4 and 5; 0076].
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Kinley et al. (US 2005/0136520) in view of Reppas et al. (WO 2012/ 071547) and Dysvik et al. Co-fermentation Involving Saccharomyces cerevisiae and Lactobacillus Species Tolerant to Brewing-Related Stress…” Frontiers in Microbiology February 2020 vol. 11 as applied to claim 1 above and in further view of Blotsky et al. (US 2014/0030228) and Tanaka et al. (US 2007/0020250).
Regarding Claim 5: Kinley as modified discloses as discussed above in claim 1. Kinley does not disclose wherein the biomass comprises one or more bacteriocin and the recombinant LAB host cell expresses (i) one or more second polypeptide conferring immunity to the one or more bacteriocin and/or (ii) the one or more bacteriocin.
Blotsky discloses using a bacteriocin in a biomass [0020; 0031; 0032; claims 12 and 13].
Tanaka discloses lactic acid bacteria that have resistance to bacteriocin [0015; 0049; 0065].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the biomass of Kinley to include a bacteriocin as in Blotsky in order to help control the growth of undesirable microorganisms. Further, it would have been obvious to incorporate a bacteriocin resistant gene in the recombinant LAB of modified Kinley as in Tanaka in order to retain the viability of the LAB in the biomass when it is in the presence of the bacteriocin.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Kinley et al. (US 2005/0136520) in view of Reppas et al. (WO 2012/ 071547) and Dysvik et al. Co-fermentation Involving Saccharomyces cerevisiae and Lactobacillus Species Tolerant to Brewing-Related Stress…” Frontiers in Microbiology February 2020 vol. 11 as applied to claim 1 above and in further view of Medoff (US 2010/0124583) and De Vos et al. (EP 0228726).
Regarding Claim 6: Kinley as modified discloses as discussed above in claim 1. Kinley discloses wherein the biomass comprises one or more antibiotic and the recombinant LAB host cell expresses one or more third heterologous polypeptide conferring resistance to the one or more antibiotic or is adapted to be resistant to the antibiotic.
Medoff discloses adding antibiotics to a biomass [0512; 0696].
De Vos discloses providing antibiotic resistant genes in a host cell and that the host cell can be a lactic acid bacteria [abstract; pg. 3, lines 1-6; claims 1, 2].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the biomass of Kinley to include antibiotics as in Medoff in order to help control the growth of undesirable microorganisms. Further, it would have been obvious to incorporate an antibiotic resistant gene in the recombinant LAB of modified Kinley as in De Vos in order to retain the viability of the LAB in the biomass when it is in the presence of the antibiotics.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Kinley et al. (US 2005/0136520) in view of Reppas et al. (WO 2012/ 071547) Dysvik et al. Co-fermentation Involving Saccharomyces cerevisiae and Lactobacillus Species Tolerant to Brewing-Related Stress…” Frontiers in Microbiology February 2020 vol. 11 as applied to claim 1 above and in further view of Blank et al. (US 2002/0034815).
Regarding Claim 7: Kinley as modified discloses as discussed above in claim 1. Kinley discloses wherein the recombinant LAB host cell expresses one or more fourth polypeptide having proteolytic activity, wherein the one or more fourth polypeptide is a native polypeptide or a heterologous polypeptide.
Blank discloses that the recombinant LAB cell is able to produce proteases [0085].
At the effective filing date of the invention it would have been obvious to one of ordinary skill to further modify the LAB of modified Kinley to include the production of protease by the LAB as in Blank in order to hydrolyze the proteins present within the biomass of Kinley.
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Kinley et al. (US 2005/0136520) in view of Reppas et al. (WO 2012/ 071547) Dysvik et al. Co-fermentation Involving Saccharomyces cerevisiae and Lactobacillus Species Tolerant to Brewing-Related Stress…” Frontiers in Microbiology February 2020 vol. 11 as applied to claim 1 above and in further view of Turano et al. (US 2009/0077693).
Regarding Claims 8-10: Kinley as modified discloses as discussed above in claim 1. Kinley does not disclose wherein the recombinant LAB host cell expresses one or more fifth polypeptide involved in the metabolism of one or more amino acid, wherein the one or more fifth polypeptide is a native polypeptide or a heterologous polypeptide (claim 8); wherein the one or more amino acid comprises glutamate/gamma-amino butyrate (claim 9); wherein the one or more fifth polypeptide comprises: a glutamate decarboxylase; and/or a glutamate/gamma-amino butyrate (GABA) transporter (claim 10).
Turano discloses the recombinant production of GABA by lactic acid bacteria and also discloses glutamate decarboxylase [0003; 0004; 0009; 0011; 0058; 0072].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the method of Kinley to include GABA production and production of glutamate decarboxylase as in Turano in order to provide increased tolerance to environmental stress.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Kinley et al. (US 2005/0136520) in view of Reppas et al. (WO 2012/ 071547) Dysvik et al. Co-fermentation Involving Saccharomyces cerevisiae and Lactobacillus Species Tolerant to Brewing-Related Stress…” Frontiers in Microbiology February 2020 vol. 11 as applied to claim 1 above and in further view of Medoff (AU 2014/256919).
Regarding Claim 11: Kinley as modified discloses as discussed above in claim 1. Kinley does not disclose wherein the recombinant LAB host cell is from the genus Lactobacillus sp. and/or from the species Lactobacillus paracasei.
Medoff discloses processing a biomass in the presence of genetically modified/recombinant bacteria including L. paracasei [00092].
At the time of the invention it would have been obvious to one of ordinary skill in the art to modify the method of Kinley to include Lactobacillus paracasei as the host cell as in Medoff since Medoff discloses processing a biomass using recombinant L. paracasei thus showing the modifiability of the species within the genus Lactobacilli, disclosed in Kinley.
Further, it would have been obvious to one of ordinary skill in the art at the time the invention was made to use L. paracasei as the host cell because it can be genetically modified to express the desired heterologous enzymes [00095] and since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious engineering choice. In re Leshin 125 USPQ 416
Claims 16 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Kinley et al. (US 2005/0136520) in view of Reppas et al. (WO 2012/071547) Dysvik et al. Co-fermentation Involving Saccharomyces cerevisiae and Lactobacillus Species Tolerant to Brewing-Related Stress…” Frontiers in Microbiology February 2020 vol. 11 as applied to claim 15 above and in further view of Borst et al. (US 20190185885).
Regarding Claim 16: Kinley discloses as discussed above in claim 15. Linley discloses evaporating the thin stillage to attain a syrup [0076; 0082; 0088].
Kinley does not disclose adding the syrup to the wet cake to obtain distillers wet grains with solubles (DWGS); drying the syrup to obtain dried solubles (DS); and/or further comprising drying the DWGS to obtain distillers dried grains with solubles (DDGS).
Borst discloses a dry milling process where after the production of whole stillage and separation of thin stillage, evaporating the thin stillage to form a syrup and then adding the syrup back to the wet cake to form wet distiller’s grains with solubles and then drying the WDGS to produce DDGS [Fig 1, claim 23].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the method of Kinley to further include the step of adding the syrup to wet cake as in Borst in order to produce WDGS and drying to produce DDGS in order the utilize all of the components of the fermentation process.
Regarding Claim 19: Kinley as modified discloses as discussed above in claim 16. Kinley syrup obtain by the process of claim 16 which as modified comprises a recombinant host LAB [Figs. 4 and 5; 0076].
Response to Arguments
19. The 103(a) rejections of claims 1-4, 12, 13, 14, 15, 17 and 18 over Kinley et al. (US 2005/0136520) in view of Reppas et al. (WO 2012/071547) have been withdrawn.
20. The 103(a) rejection of claim 5 over Kinley et al. (US 2005/0136520) in view of Reppas et al. (WO 2012/ 071547) and in further view of Blotsky et al. (US 2014/0030228) and Tanaka et al. (US 2007/0020250) has been withdrawn.
21. The 103(a) rejection of claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Kinley et al. (US 2005/0136520) in view of Reppas et al. (WO 2012/ 071547) and in further view of Medoff (US 2010/0124583) and De Vos et al. (EP 0228726) has been withdrawn.
22. The 103(a) rejection of claim 7 over Kinley et al. (US 2005/0136520) in view of Reppas et al. (WO 2012/ 071547) and in further view of Blank et al. (US 2002/0034815) has been withdrawn.
23. The 103(a) rejections of claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Kinley et al. (US 2005/0136520) in view of Reppas et al. (WO 2012/ 071547) and in further view of Turano et al. (US 2009/0077693) have been withdrawn.
24. The 103 (a) rejection of claim 11 over Kinley et al. (US 2005/0136520) in view of Reppas et al. (WO 2012/ 071547) and in further view of Medoff (AU 2014/256919) has been withdrawn.
25. The 103(a) rejections of claims 16 and 19 over Kinley et al. (US 2005/0136520) in view of Reppas et al. (WO 2012/071547) and in further view of Borst et al. (US 20190185885) have been withdrawn.
26. The Applicants assert that Kinley and Reppas are non-analogous art because they do not seek to modulate the nutritional properties of whole stillage.
In response to applicant's argument that both Kinley and Reppas are nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, both Kinley and Reppas are in the field of endeavor since the references are directed to fermentation of a biomass with yeasts and/or lactic acid bacteria and products obtained by the fermentation process . ("The field of endeavor is ‘not limited to the specific point of novelty, the narrowest possible conception of the field, or the particular focus within a given field.’") (quoting Unwired Planet, LLC v. Google Inc., 841 F.3d 995, 1001, 120 USPQ2d 1593, 1597 (Fed. Cir. 2016)).
Pertinent Prior Art
27. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Titilayo et al. “Synergistic microbial interactions between lactic acid bacteria and yeasts…” Food Control vol. 110 2020 Available Online October 25 2019; discloses synergistic actions between lactic acid bacteria in yeasts in different fermented foods and beverages [abstract]. Titilayo discloses fermented beverages containing both LAB and yeasts [pg. 3 “2.4”; 4, Food and beverage fermentation by LAB and yeasts”]. Titilayo discloses synergism between LAB and yeasts [pgs. 6-7, “6. LAB-yeast synergistic…”].
Conclusion
28. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FELICIA C TURNER whose telephone number is (571)270-3733. The examiner can normally be reached Mon-Thu 8:00-4:00 pm.
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/Felicia C Turner/Primary Examiner, Art Unit 1793