Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
2. Applicants’ arguments and amendments filed 1/14/2026, overcomes the rejections of record. Even if the amended independent claim 1 and dependent claim 3 are amended further, however, examiner made a new ground of rejection by considering a new primary prior art and one new secondary prior art to strengthen motivation for exopolysaccharide production to make better rejection.
Therefore, the following action is made non-final.
Any objections and/or rejections made in the previous action, and not repeated below, are hereby withdrawn.
Status of the application
3. Claims 1-20 are pending in this application.
Claims 1-20 have been rejected.
Claim Rejections - 35 USC § 103
4. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
5. The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
6. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
a. Determining the scope and contents of the prior art.
b. Ascertaining the differences between the prior art and the claims at issue.
c. Resolving the level of ordinary skill in the pertinent art.
d. Considering objective evidence present in the application indicating obviousness or non-obviousness.
7. Claim 1, 2, 4, 6, 7, 8, 10, 11-13, 15 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Lyons et al. US 2010/0248320 A1 in view of Dawley et al. US 2003/0232109 in view of Thorne et al. EP 0538049 A1.
8. Regarding claim 1, 2, 7, Lyons et al. discloses that an ethanologenic feedstock e.g. corn cob (at least in [0013], [0016], ) can be used to ferment with the ethanologenic organism e.g. S. cerevisiae yeast to make ethanol (at least in [0013], [0016], [0039]). Lyons et al also discloses that the lignocellulosic feedstock originated from alcohol industry as by-product ([0070]). Lyons et al. also discloses that fermentation of fibrous by-product or residue filamentous fungus which increases the protein content of lignocellulosic feedstock further to make more nutritionally enriched high protein containing animal feed composition ([0020]). Lyons et al. also discloses that the lignocellulose feedstock can be DDGS ([0007]) and filamentous fungus can be Aurebasidium spp ([0009], [0038]). It is to be noted that this second fermentation using Aurebasidium spp would have obvious the more biomass production to enhance further protein content and is also disclosed by Lyons et al. ([0020]).
However, Lyons et al. does not specifically disclose about (i) specific fermentation condition to make claimed the claim limitation of “wherein the concentration contain at least 45% protein content” during a secondary microbial fermentation of DDGS and (ii) the specific fermentation condition, which allows Aurebasidium spp. to use DDGS to make exopolysaccharide production and the second fermentation is distinct from first ethanolic fermentation as claimed in amended claim 1.
With respect to (i), firstly, it is to be noted that Dawley et al. discloses that after the fermentation process using yeast organism using fermentable sugar from lignocellulosic material, the separated insoluble solid rich in high protein e.g. 55-65% and in one example, it is 63.6% can be achieved ( at least in Abstract, claim 1 of Dawley et al.).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Lyons et al. to include the teaching of Dawley et al. at the step of making ethanol using yeast organism mediated method which provides the separated insoluble solid rich in high protein e.g. 55-65% content after fermentation step ( at least in Abstract, [0047]).
It is to be noted that Dawley et al. discloses that ethanolic fermentation make DDGS having protein 55-65% by weight (Claim 1 of Dawley et al.).
Therefore, the methods of Lyons et al. in view of Dawley et al. would have obvious higher protein content containing end product after the end of second fermentation by A pullulans because Lyons et al. discloses that fermentation of fibrous by-product or residue including DDGS ( [0007], [0020], [0039]) fermented by filamentous fungus e.g. Aureobasidium spp increases the biomass which increase the protein content of lignocellulosic feedstock further to make more nutritionally enriched high protein containing animal feed composition ([0020]). This is more than 55% by weight and, therefore, would meet HP-DDGS as claimed in claim 1.
Secondly, it is also to be noted that the amount of protein in HP-DDGS depends on the degree of drying. It is, therefore, optimizable.
Absent showing of unexpected results, the specific amount of protein content in the fermented by-product distiller’s grain is not considered to confer patentability to the claims. As the moisture content is variable that can be modified, among others, by adjusting the drying condition, the precise amount would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the amount of protein content to make HP-DDGS in Lyons et al., to amounts, including that presently claimed, in order to obtain the desired effect e.g. desired HP-DDGS (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
With respect to (ii), regarding exopolysaccharide formation, it is to be noted that Lyons discloses that the lignocellulose feedstock can be DDGS ([0007]) which can be fermented by filamentous fungus including Aurebasidium spp ([0009]).
Thorne et al. discloses that pullulan is water soluble exopolysaccharide which is made by growing A pullulans (Abstract ) biomass under aerobic condition and having its use in diversified applications including food (SEE first and second paragraphs under Description and see Last claim, See last paragraph under claims).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Lyons et al. in view of Dawley et al. to consider further second fermentation using separated insoluble solid containing high protein DDGS produced at the first fermentation step of ethanol production step ([0007]) and by selecting the filamentous fungus Aureobasidium spp. (at least in [0009]) from the many equivalent broadly disclosed filamentous fungus microorganisms of Lyons et al. (at least in [0009], [0013], [0026], [0027], [0066], [0070]) by including the teaching of Thorne et al. EP 0538049 A1 who discloses that pullulan a water soluble exopolysaccharide which is made by growing A pullulans under aerobic condition and having its use in diversified applications including food (SEE first and second paragraphs under Description and see Last claim, See last paragraph under claims).
Therefore, Lyons et al. in view of Dawley et al. and Thorne et al. meet the amended claim limitation of “polysaccharide produced during a secondary microbial fermentation of DDGS” as claimed in claim 1. Lyons et al. in view of Dawley et al. and Thorne et al. disclose two separate fermentation steps, first anaerobic fermentation to make ethanol by Saccharomyces cerevisiae and second one is separate fermentation to make exopolysaccharide by using separate organism A. pullulans under aerobic fermentation condition which meets “ at least two separately employed microbes” and “ a second , separately employed microbe ferments the DDGS in a subsequent fermentation step to generate the protein concentrate , wherein said secondary fermentation is distinct from ethanol fermentation” as claimed in amended claim 1.
9. Regarding claim 4, 6, both Lyons et al. and Dawley et al. discloses the steps and method provides fermenting the enzyme treated mash with yeast after liquefaction step, followed by separating the insoluble and soluble solids by centrifugation method (At least in [0033]), which were dried separately. Dawley et al. also discloses that the separated insoluble solid is rich in fat (7.3%), crude fiber (4.5%) and high protein (63.6%) (at least in [0047]).
As discussed above, for method claim 4, which depends on product claim 1, Dawley et al. discloses a method of making high protein DDGS (55-65% by weight) from corn endosperm (Abstract), the method provides fermenting the enzyme treated mash with yeast after liquefaction step, followed by separating the insoluble and soluble solids by centrifugation method, which were dried separately. Dawley et al. also discloses that the separated insoluble solid is rich in fat (7.3%), crude fiber (4.5%) and high protein (63.6%) (at least in [0047]). Therefore, Dawley et al. meets step (a) and (b) of claim 4.
As discussed for claim 1 above, Thorne et al. EP 0538049 A1 discloses that pullulan is water soluble exopolysaccharide which is made by growing A pullulans under aerobic condition and having its use in diversified applications including food (SEE first and second paragraphs under Description and see Last claim, See last paragraph under claims). Therefore, it
As discussed for claim 1 above, Lyons et al. discloses separation step to separate ethanol from fermentation residues ([0018]). It is within the skill of one of ordinary skill in the art to perform the separation step using any conventional method to separate and collect supernatant and solids at the step of (d) of claim 4.
Therefore, Lyons et al. in view of Dawley et al. teach substantially the same product produced by substantially the same method as instantly claimed by applicant; where the claimed and prior art products are produced by substantially identical processes, a prima facie case of obviousness has been established. To switch the order of performing process steps, i.e. the order of the addition of the ingredients into the final mixture, would be obvious absent any clear and convincing evidence and/or arguments to the contrary (MPEP 2144.04 [R-1]). “Selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results". Therefore, absent evidence to the contrary, it would have been obvious to one of ordinary skill in the art to add the salt to the wheat flour and the rice flour before adding the hot water.
Regarding claim 6, claim 6 depends on claim 4. Claim 6 recites “ optionally”. Therefore, refractionating step is not addressed.
10. Regarding claim 5 , Thorne et al. discloses pullulan is exopolysacchariod which is made by growing A pullulans under aerobic condition (SEE second paragraph under Description and see Last claim, See last paragraph under claims).
11. Regarding claim 8, it is to be noted that Lyons et al. discloses another second microbe from genus Aureobasidium spp., to provide a source of glucoamylase enzyme to provide fermentable sugar. Therefore, the disclosed Aureobasidium spp. includes any sub spp. of Aureobasidium produce exopolysaccharide This includes anyone or all of the claimed Aureobasidium spp. having respective NRRL Nos as claimed in claim 8.
12. Regarding claim 10, Dawley et al. discloses that the high protein product contains 7.3% fat (at least in [0047]) and it meets claim 8.
13. Regarding claim 11, 12, 13, Lyons et al. discloses that the feed or feed supplement can be used in animal feed for animal nutrition ([0020], [0021], [0022]) including fish, human food also ([0022]). It is to be noted that “at least 20% by weight” as claimed in claim 11 can be interpreted as it can be 100% by weight also. Therefore, modified Lyons et al. meets claims 11-13.
14. Regarding claim 15, as discussed for claims 1 and 11 above , in detail, Lyons et al. in view of Dawley et al. and Thorne et al. disclose one S. cerevisiae used in first fermentation for ethanol production and the second one is A pullulans used in second fermentation for polysaccharide production which meets the claim limitation of “ at least two separately employed microbes” as claimed in claim 15.
15. Regarding claim 20, Dawley et al. discloses that the addition of enzymes can include cellulase to produce fermentable sugar from endosperm fraction of corn before fermentation (at least in [0031], [0032]).
One of ordinary skill in the art, before the effective filling date of the claimed invention, would have been motivated to modify Silver et al. by introducing the teaching of Dawley et al. to make fermentable sugar from endosperm fraction of corn before fermentation (at least in [0031], [0032]) which is suitable for fermentation to make further high protein DDG (55-65% by weight) and low carbohydrate containing high nutritional product.
16. Claims 3, 9, are rejected under 35 U.S.C. 103 as being unpatentable over Lyons et al. US 2010/02483200 A1 in view of Dawley et al. US 2003/0232109 in view of Thorne et al. EP 0538049 A1 as applied to claim 2 and further in view of Gay et al. USPN 3958015.
17. Regarding claims 3, 9 Lyons et al. in view of Dawley et al. and Thorne et al. are specifically silent about the claim limitation of high quality soy protein concentrate as claimed in claim 3.
Claim 3 depends on claim 2 and claim 2 depend on claim 1. Therefore, claim 3 can be interpreted as in addition to claimed HP-DDGS (>45% protein), it includes high quality Soy protein concentrate (HQSPC).
Gay is used to consider HQSPC. Gay discloses that same fermentation using soy protein material and same yeast microbe(s) can produce (HQSPC).
Gay et al. discloses a plant protein product intended for human or animal food (claim 1 of Gay et al.) wherein the carbohydrates are first hydrolyzed using enzymes like cellulase etc. (col 3 lines 30-32) and the hydrolyzed proteinaceous material is then fermented by yeast (at least in Abstract). Gay et al. also discloses that soy can be soy meal as starting raw material (at least in claim 5 of Gay et al.) to meet claim 9. Gay et al. also discloses that the plant material can be corn also (at least in Example 5). Therefore, Gay et al. is combinable. It is also to be noted that the corn endosperm is also treated with the enzymes like cellulase etc. to make fermentable sugar as disclosed by Dawley et al. ([0031], [0032]), therefore, both the starting raw materials (corn endosperm for DDGS [0031], [0032] of Dawley et al. and col 3 lines 30-35) have similar conditions and can be processed together at the first step of making fermentable sugar which is metabolizable by commonly used fermenting microorganism yeast.
Gay et al. also discloses that the hydrolyzed suspension is then fermented by yeast. The fermented suspension is pasteurized and dried (col. 3, Detailed Description of the Invention). Gay et al. also discloses that the dried concentrate comprises 60% protein and less than 1% reducing sugar (Example 1) and soy protein contain balanced amino acid with enriched lysine (col 1 lines 25-27).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to introduce the hydrolyzed soy material containing a source of modified simple sugar which is metabolized by yeast to provide food for fermentable yeast (col 3 lines 32-35), and make final product with low carbohydrate high protein product (Abstract). Therefore, as because yeast is the common fermentable microorganism, therefore, one of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify the combined fermentation method with the combined starting materials from Lyons et al. in view of Dawley and Thorne et al. and modifying with metabolizable sugar containing soy raw material of Gay et al. (col 3 lines 30-35), to achieve high protein containing HP-DDGS and HQSPC as claimed in claim 3.
18. Claim 14, 17 are rejected under 35 U.S.C. 103 as being unpatentable over Lyons et al. US 2010/0248320 A1 in view of Dawley et al. US 2003/0232109 in view of Thorne et al. EP 0538049 A1 as applied to claim 11 and further in view of Reddy et al. USPN 5225228.
19. Regarding claims 14, 17 Lyons et al. in view of Dawley et al. and Thorne et al. are specifically silent about claim limitations of claims 14, 17.
Reddy et al. discloses that the flavor of DDGS is improved with the addition of sodium carbonate, amino acids, and potato starch (in Reddy et al. (at least in claim 1 of Reddy et al.).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Lyons et al. in view of Dawley et al. and Thorne et al. to include the teaching of Reddy et al. to incorporate sodium carbonate, amino acids, and potato starch to DDGS to improve its flavor at least in claim 1 of Reddy et al.) to be used for food composition.
20. Claims 16 , 18, 19 are rejected under 35 U.S.C. 103 as being unpatentable over Lyons et al. US 2010/0248320 A1 in view of Dawley et al. US 2003/0232109 in view of Thorne et al. EP 0538049 A1 as applied to claims 13, 1, 11 respectively and further in view of Silver et al. (CA 2603281 A1).
21. Regarding claim 16, Lyons et al. discloses that the by-product as concentrate can be used in animal feed ([0021], [0022]) including fish, human food also ([0022]).
`Lyons et al. in view of Dawley et al. and in view of Thorne et al. are silent about specific human food as claimed in claim 16.
Silver et al. discloses that it can be used in foods like cereal, crackers etc. ([0018], [0019]) as claimed in claim 16, and also for claim 16.
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Lyons et al. in view of Dawley and Thorne et al. to include the teaching of Silver et al. in order to use the same by HP-DDGS product to make foods like cereal, crackers etc. ([0018], [0019]) as desired choice of food.
22. Regarding claims 18, 19, Lyons et al. in view of Dawley et al. and Thorne et al. are specifically silent about light color of DDGS as claimed in claims 18,19.
Silver et al. discloses the addition of other ingredients to make light colored DDGS ([0006], [0013]), therefore, can make light colored product to meet claim 18. One of ordinary skill in the art would have been motivated to include ingredients to make light colored DDGS ([0006], [0013]), in order to obtain the desired effect e.g. desired light color compared to the same composition that has undergone Maillard reaction as claimed in claim 18.
Silver et al. also discloses that L value can be 63-70 (pages 15, 16 [0027]) which meets claim 19. Silver et al. also discloses that L value can be 63-70 (pages 15, 16 [0027]) which meets claim 19. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Lyons et al. in view of Dawley and Thorne et al. to include the teaching of Silver et al. to make desired light colored DDGS ([0006], [0013]).
However, it is optimizable. It is within the skill of one of ordinary skill in the art one of ordinary skill in the art would have been motivated to optimize desired light colored DDGS with the addition of the proportionate amount of ingredients and with a reasonable expectation of success because darker colored particles have more bitter taste, with astringent and burned flavors and may be visually objectionable in light colored foods (at least on page 7 last four lines).
Absent showing of unexpected results, the specific amount of lighter color by evaluating Hunter brightness L, a etc. is not considered to confer patentability to the claims. As the intensity of color (dark to light) of DHP-DDGS is variable that can be modified, among others, by adjusting the amount of ingredients used, the precise color intensity would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the intensity of color with the addition of ingredients which can make lighter color in Silver et al., to amounts, including that presently claimed, in order to obtain the desired effect e.g. desired light color compared to the same composition that has undergone Maillard reaction (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Pertinent Note(s)
23. EP 0112661 A 2 discloses that the production of other microbial exopolysaccharides, e.g. the production of pullulan by organisms of the Aureobasidium spp.
Response to arguments
24. Applicants’ arguments and amendments overcome the rejections of record. Accordingly, a new primary prior art by Lyons et al. is used to address amended
independent claim 1.
The reason is Lyons et al. discloses an ethanologenic feedstock e.g. corn cob (at least in [0013], [0016], ) can be used to ferment with the ethanologenic organism e.g. S. cerevisiae yeast to make ethanol (at least in [0013], [0016], [0039]) which is first fermentation and anaerobic process.
Lyons et al also discloses that the lignocellulosic feedstock can be DDGS ([0007]) which can be fermented by filamentous fungus including Aurebasidium spp. ([0009]). Lyons et al. broadly discloses both types of fermentation.
However, Lyons et al. is silent about (i) high protein -dried distiller’s grain (DDGS) having “at least 45% protein content” (ii) exopolysaccharide production and the second fermentation is distinct from first ethanolic fermentation.
Therefore, Dawley is used to address specifically (i) high protein -dried distiller’s grain (DDGS) having “at least 45% protein content” and Thorne et al. is used to address (ii) exopolysaccharide production and the second fermentation is distinct from first ethanolic fermentation. above. It is discussed in the office action above.
As because, the arguments and amendments of claim 1 overcome the rejection made by using Silver et al. as primary prior art in this office action. Therefore, Silver et al. is not used in this office action. Therefore, the arguments made for Silver et al. is considered as moot.
However, Silver et al. is used as secondary prior art to specifically address the specific claim limitation of specific food as claimed in claim 16 and also the method of making desired light colored DDGS to meet claims 18, 19.
25. Applicants argued that “Dawley et al. do not disclose:
-secondary fermentation of DDGS itself,
-employing a second, separately employed microbe,
producing exopolysaccharide, or
-generating a purified protein concentrate via secondary fermentation.
Dawley's "high protein DDG" is a static by-product of ethanol fermentation, not a
biologically transformed DDGS substrate. Thus, the product of the processes described in Silver et al. and Dawley et al. again, which results in essentially unchanged DDGS, would not be expected by the skilled artisan to be the same as fermented DDGS concentrate”.
In response, as mentioned in the office action above, Dawley et al. is specifically used to modify Lyons et al. to include the teaching of Dawley et al. at the step of making ethanol using yeast organism mediated method which provides the separated insoluble solid rich in high protein e.g. 55-65% content after fermentation step ( at least in Abstract, [0047]). Therefore, Dawley et al. is maintained as secondary prior art.
26. It is to be noted that Thorne et al. discloses that pullulan is water soluble exopolysaccharide which is made by growing A pullulans. Therefore, Thorne et al. is considered to be a secondary prior art to reject independent claim 1 due to amendment in relation to the amended claim limitation of “wherein said secondary fermentation is distinct from ethanol fermentation” and “exopolysaccharide produced during a secondary microbial fermentation of DDGS” and “a second , separately employed microbe ferments the DDGS in a subsequent fermentation step” as claimed in claim 1. The first ethanol fermentation is anaerobic and so it is distinct from A pullulan mediated pullulan exopolysaccharide production by aerobic fermentation method and discussed in the office action above.
As Thorne et al. meets claim 5, therefore, prior used gay secondary prior art is not used to reject claim 5.
27. Applicants’ further arguments made for secondary prior arts by Baez-Vasquez et al. and Landvik et al. are considered as moot because these secondary prior arts are not considered in this office action.
The action is made as non-final.
Conclusion
28. Any inquiry concerning the communication or earlier communications from
the examiner should be directed to Bhaskar Mukhopadhyay whose telephone number is (571)-270-1139.
If attempts to reach the examiner by telephone are unsuccessful,
examiner’s supervisor Erik Kashnikow, can be reached on 571-270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BHASKAR MUKHOPADHYAY/
Examiner, Art Unit 1792
Prosecution Insights