DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 July 23, 2026 has been entered.
Claim 25 is new. Claims 1-11, 13 and 18-25 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.
Claim 25 is 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.
New claim 25 requires “wherein the additional enzymes include a first enzyme comprising an endoprotease, a second enzyme comprising a first exopeptidase, and a third enzyme comprising a second exopeptidase, and wherein the enzymatic hydrolysis step further makes use of a cellulase.”
The present specification states “in the process according to the invention the hydrolysis is carried out with additional enzymes with different functionalities such as alpha amylase, other fiberases and lipases (p. 10/L1-4). The present specification also states “[i]n yet an embodiment of the present invention the proteases contain at least one endoprotease and two exopeptidases” (p. 10/L20-21) . There is no support to claim the “additional enzymes” contain at least one endoprotease and two exopeptidases.
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 1-11, 13 and 18-24 are rejected under 35 U.S.C. 103 as being unpatentable over Te Biesebeke et al. (US 2014/0017356) in view of Long et al. (US 2017/0327855) as evidenced by Novonesis (“Flavourzyme®”, https://www.novonesis.com/en/biosolutions/food-and-beverages/other-foods/animal-co-products/flavourzyme, downloaded December 31, 2025) and Merz et al. (“Flavourzyme, an Enzyme Preparation with Industrial Relevance: Automated Nine-Step Purification and Partial Characterization of Eight Enzymes”, Journal of Agricultural and Food Chemistry, Vol. 63, (2015), pp. 5682-5693).
Regarding claims 1, 6, 9, 10 and 22, Te Biesebeke et al. disclose a process for making a whole grain cereal based extract comprising the steps of: (a) providing a whole grain cereal; (b) subjecting the whole grain cereal to a first grinding; (c) mixing the ground whole grain with water to make a slurry; (d) subjecting the slurry of whole grain cereal to hydrolysis to a obtain a modified whole grain cereal; (e) separating the soluble fraction of the modified whole grain cereal from an insoluble fraction of the modified whole grain cereal ([0013]-[0018], [0043], Figure 1).
Te Biesebeke et al. disclose the hydrolysis is conducted by adding one or more endogenous enzyme(s) and/or by the addition of one or more exogenous enzymes(s) ([0080]). Te Biesebeke et al. disclose that in one embodiment, at least one of the endogenous enzymes and/or exogenous enzymes is a protease and/or an amylase (i.e., wherein the amylase is considered an “additional enzyme” -[0083]). Te Biesebeke et al. disclose the amylase may be an α-amylase ([0085]). Te Biesebeke et al. also disclose the use of dextrinases, cell-wall hydrolyzing enzymes and amyloglucosidases can be used in the hydrolysis step ([0081]).
Te Biesebeke et al. disclose the method for separating the soluble fraction from the insoluble fraction is selected from the group consisting of by filtration, centrifugation, decanting or a combination thereof ([0088]).
While Te Biesebeke et al. disclose the use of cell-wall hydrolyzing enzymes, the reference does not explicitly disclose lytic polysaccharide monooxygeneases (LPMOs).
Long et al. teach a process of for treating crop kernels (i.e., whole grain cereal) with enzymes to obtain a soluble fraction ([0021]-[0022], [0024]-[0025], [0079]-[0085], [0138], claim 1). Long et al. teach treating soaked and milled crop kernels with an enzyme composition comprising a protease and a cellulolytic composition comprising (A)(i) a cellobiohydrolase I (i.e., additional enzyme) (ii) a cellobiohydrolase II and an AA9 polypeptide (i.e., a lytic polysaccharide monooxygenase) having cellulolytic enhancing activity.
Te Biesebeke et al. and Long et al. are combinable because they are concerned with the same field of endeavor, namely treating whole grain cereals with hydrolyzing enzymes to obtain a soluble fraction. Given Te Biesebeke et al. disclose a process wherein hydrolysis can be conducted using cell-wall hydrolyzing enzymes, since Long et al. teach is known to hydrolyze whole grain cereal with a combination of cellulolytic enzymes including an AA9 polypeptide (i.e., lytic polysaccharide monooxygenease-LPMO), it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the present application to have used the cellulolytic composition of Long et al. in the method of Te Biesebeke et al. to obtain improved recovery of the soluble fraction from whole grain cereal.
Regarding claim 2, modified Te Biesebeke et al. disclose all of the claim limitations as set forth above. Te Biesebeke et al. disclose where the whole grain cereal is barley or oat ([0066]). Te Biesebeke et al. does not require the whole grain cereal is malted ([0041], Figure 1).
Regarding claim 3, modified Te Biesebeke et al. disclose all of the claim limitations as set forth above. Te Biesebeke et al. disclose the soluble fraction obtained from the separation step (step (e)) is concentrated ([0089]).
Regarding claim 4, modified Te Biesebeke et al. disclose all of the claim limitations as set forth above. Te Biesebeke et al. disclose the concentrate may comprise at least of 10% and up to 97.5% (w/w) of the soluble fraction before concentration ([0089]).
Regarding claim 5, modified Te Biesebeke et al. disclose all of the claim limitations as set forth above. Te Biesebeke et al. disclose performing the enzymatic hydrolysis at a temperature of 20° to 100°C and once the hydrolysis is completed, inactivating the enzymes by changing the temperature to a temperature in the range of 40° to 130°C ([0003], [0086]).
While Te Biesebeke et al. disclose heating the slurry simultaneously with the hydrolysis step rather than before hydrolysis, selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected properties (MPEP §2144.04 IVC).
Here, regardless of whether the slurry is heated before or during hydrolysis, the starch would be expected to gelatinize.
Regarding claims 11 and 13, Te Biesebeke et al. disclose a whole grain cereal-based extract beverage ingredient comprising on a dry matter basis 10-50% (w/w) of a whole grain cereal-based extract (i.e., soluble fraction wherein the soluble fraction can be concentrated-[0089]), 15-45% (w/w) of a skimmed milk powder, 8-30% (w/w) sucrose; 10-20% (w/w) cocoa; and 5-15% (w/w) fat ([0108]).
Given the combination of Te Biesebeke et al. and Long et al. disclose a whole grain cereal-based extract produced by a method substantially similar to the claimed method (claim 1) and since Te Biesebeke et al. disclose a beverage ingredient comprising the components of claim 13, intrinsically the beverage ingredient would comprise the claimed carbohydrate, protein, total dietary fiber, ash and fat as required by claim 11.
Regarding claims 7 and 8, Te Biesebeke et al. disclose all of the claim limitations as set forth above. Te Biesebeke et al. is silent with respect to the protease containing at least one endoprotease and two exopeptidases.
Long et al. teach using a protease complex from A. oryzae sold under the tradename of Flavourzyme® ([0091]). As evidenced by Novonesis, Flavourzyme® is known to comprise a blend of endo- and exo-peptidases. As evidenced by Merz, the exopeptidases of Flavourzyme include aminopeptidases (Abstract).
Given Te Biesebeke et al. disclose a process of treating whole grain cereal to obtain a soluble fraction wherein ground and soaked whole grain cereal is treated with protease enzyme, since Long et al. disclose a similar process using a protease wherein the protease is a complex from A. oryzae sold under the tradename of Flavourzyme®, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the present application to have used Flavourzyme® as the protease in the process of Te Biesebeke et al. with a reasonable expectation of success.
Regarding claims 18-20, modified Te Biesebeke et al. disclose all of the claim limitations as set forth above. Te Biesebeke et al. disclose a process of preparing a beverage having improved organoleptic and/or improved nutritional value, said process comprising the steps of: (a) providing a whole grain cereal-based extract beverage ingredient of claim 11; and (b) mixing the ingredient with a liquid component to obtain the beverage ([0025], [0033]). Te Biesebeke et al. disclose a beverage comprising the whole grain cereal-based extract beverage ingredient of claim 11 and a liquid component ([0026]). Te Biesebeke et al. disclose the liquid component may be any kind of consumable liquid including water, milk, fruit juice, vegetable juice or any combination thereof ([0118]).
Regarding claim 21, modified Te Beisebeke et al. disclose all of the claim limitations as set forth above. Given the combination of Te Beisebeke et al. and Long et al. disclose a beverage substantially similar to that of the present invention, in follows the beverage would comprise the total energy requirements of claim 21.
Regarding claim 23, modified Te Biesebeke et al. disclose all of the claim limitations as set forth above. Given the combination of Te Biesebeke et al. and Long et al. disclose a process of making a whole grain cereal based extract substantially similar to claim 1, inherently some insoluble components of the ground grain would be converted to soluble components by way of hydrolysis.
Regarding claim 24, modified Te Biesebeke et al. disclose all of the claim limitations as set forth above. Te Biesebeke et al. disclose a single grinding step prior to enzymatic hydrolysis (see subjecting the ground whole grain cereal to a hydrolysis-[0034]-[0037]).
Response to Arguments
Applicant's arguments filed July 23, 2026 have been fully considered but they are not persuasive.
Applicant argues Long et al. is not from the same field of endeavor as Te Biesebeke et al. Applicant explains that Te Biesebeke et al. is directed to a method of providing a whole grain cereal based extract, while Long et al. is directed to a process that does not use a whole grain cereal (i.e., corn material having had the germ removed).
While Long et al. is not directed to the treatment of whole grain cereal, but rather grain having the germ removed, does not negate the teaching of Long et al. of a process of using composition of cellulolytic enzymes to a soluble fraction ([0021]-[0022], [0024]-[0025], [0079]-[0085], [0138], claim 1). Long et al. teach treating soaked and milled crop kernels with an enzyme composition comprising a protease and a cellulolytic composition comprising (A)(i) a cellobiohydrolase I (i.e., additional enzyme) (ii) a cellobiohydrolase II and an AA9 polypeptide (i.e., a lytic polysaccharide monooxygenase) having cellulolytic enhancing activity.
While Long et al. do not disclose all the features of the present claimed invention, Long et al. is used as teaching reference, and therefore, it is not necessary for this secondary reference to contain all the features of the presently claimed invention, In re Nievelt, 482 F.2d 965, 179 USPQ 224, 226 (CCPA 1973), In re Keller 624 F.2d 413, 208 USPQ 871, 881 (CCPA 1981). Rather this reference teaches a certain concept, namely, treating grain with an enzyme composition comprising a protease and a cellulolytic composition comprising (A)(i) a cellobiohydrolase I (i.e., additional enzyme) (ii) a cellobiohydrolase II and an AA9 polypeptide (i.e., a lytic polysaccharide monooxygenase) having cellulolytic enhancing activity, and in combination with the primary reference, discloses the presently claimed invention.
Applicant explains Long is directed to a process and treatment for “maximum starch recovery” to “provide a high purity starch” or insoluble fraction. Applicant submits that a person having ordinary skill in the art would not have reasonably considered the enzyme treatment of Long to hydrolyze the whole grain cereal of Biesebeke because the treatment of Long is specifically intended to maximize insoluble fraction recovery as opposed to the conversion of insoluble matter to soluble matter to increase the yield of the soluble fraction.”.
In this case, Long et al. teach a process wherein corn is treated with an enzyme composition to separate insoluble solids (i.e., starch and gluten) from dissolved solids ([0253]). In other words, the enzymatic hydrolysis of the corn grain allows the separation of a soluble and insoluble fraction. Te Biesebeke et al. also disclose the separation of a soluble and insoluble fraction from a ground grain by enzymatic hydrolysis ([0013]-[0018], [0043], Figure 1). One of ordinary skill in the art would have reasonably considered the enzyme combination of Long et al. to hydrolyze the ground grain of Te Biesebeke et al. to separate soluble and insoluble fractions.
Regarding claim 24, Te Biesebeke et al. disclose a single grinding step prior to enzymatic hydrolysis (see subjecting the ground whole grain cereal to a hydrolysis-[0034]-[0037]). While Te Biesebeke et al. teach a second grinding step, this step is only conducted on the insoluble fraction, post separation and recovery of the soluble fraction ([0014]).
Conclusion
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ELIZABETH A. GWARTNEY
Primary Examiner
Art Unit 1759
/ELIZABETH GWARTNEY/Primary Examiner, Art Unit 1759