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 .
This office action is in regard to the application filed on January 25, 2022 and in response to Applicant’s Amendments and Arguments/Remarks filed on May 11, 2026.
Status of Application
The amendment filed May 11, 2026 has been entered. Claims 1, 2, and 5-11 are currently pending in the application. Claims 1 and 7 have been amended; claims 3 and 4 are canceled. Claims 1, 2, and 5-11 are hereby examined on the merits.
The previous 112(b) rejection of claim 7 and the previous claim objection of claim 1 have all been withdrawn in view of Applicant’s claim amendments.
Claim Rejections - 35 USC § 103
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.
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 and 2 are rejected under 35 U.S.C. 103 as being unpatentable over Mackay et al. (US PG Pub. 2018/0199593) as evidenced by Kõiv et al. (“Gluten-degrading bacteria: availability and applications,” Applied Microbiology and Biotechnology, 2021, vol. 105, pp. 3045-3059) and in view of Jiao et al. (“Radio-Frequency Applications for Food Processing and Safety,” Annual Reviews of Food Science and Technology, 2018, vol. 9, pp. 105-127), herein after referred to as Mackay, Kõiv, and Jiao, respectively.
Regarding claims 1 and 2, Mackay teaches a process for producing a protein product (i.e., a food product) from a mixture of brewers spent grains and water (i.e., a wet mass of waste materials arising from the production process for producing beer), the process includes the steps of:
adding glucoamylase and an alkaline protease enzyme to the mixture (claim 1; Fig. 1);
raising the temperature of the mixture to 75-100 °C (i.e., boiling temperature) and holding at that temperature for 2.5-30 minutes [0027];
separating the mixture via a liquid/solid separator to obtain a liquid stream and a solids-containing stream [0027], wherein the separator can be a centrifuge [0034] (i.e., centrifuging the waste materials to eliminate most of the water present therein);
drying the solids-containing stream until substantially all remaining water is driven off;
milling the dried solids to obtain a fiber flour product [0031].
The proteases (a.k.a. peptidases) used by Mackay are enzymes that degrade gluten, as evidenced by Kõiv (Kõiv p. 3048). Thus, the protease added to the mixture of Mackay is an enzyme that breaks down gluten residues.
Mackay teaches that the product is milled (i.e., ground) to a particle size of 0.05-0.5 mm [0034], which overlaps with the claimed range of 1-0.2 mm. 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).
Mackay teaches one milling (i.e., grinding and micronizing) step, wherein the mixture is milled until the average grain particle size is any size less than about 500 microns [0024], which overlaps with the claimed range of 100-400 microns. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985).
The instant claim requires that the micronizing step occurs after the grinding step, while Mackay teaches only one step to reduce the particle size, specifically that micronizing occurs as a part of the milling (i.e., grinding) step. Mackay teaches that all of the grinding occurs in a continuous cycle in the particle reduction zone as a part of the particle size reduction stage [0024]. However, the selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results. In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946). See MPEP 2144.04.IV.C. Furthermore, it would have been obvious to one of ordinary skill in the art to mill in one step rather than two to obtain the same particle size as claimed, between 100-400 microns, absent any evidence of criticality for reducing the particle size in two steps.
Mackay does not explicitly teach that the enzyme is activated for 15-30 minutes. However, Mackay does teach that an effective amount of the protease is added to the mixture and kept until a desired degree of protein hydrolysis is achieved (i.e., the enzyme is active for a length of time) [0026]. One of ordinary skill would have recognized that the degree of hydrolysis depends on not only the temperature, but the duration of the enzymatic treatment as well. One of ordinary skill, through no more than routine experimentation, would have been able to have arrived at the claimed time for treating, depending on the extent of hydrolysis desired. Where 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). See MPEP 2144.05.II.A.
Mackay does not explicitly teach that the mixture is cooled after the boiling step. However, Mackay teaches that the mixture is raised to a boiling temperature and held there for a finite amount of time [0027]. The mixture is not expected to stay at the boiling temperature when it is no longer being heated – the temperature of the mixture after boiling is cooler than the boiling temperature. Thus, since the temperature of the mixture peaks at the boiling temperature, Mackay is considered to teach cooling the mixture after the boiling step.
Mackay is silent as to that the moisture content of the product, at the end of the drying step, is 2-14% by weight.
However, where Mackay teaches that “substantially all remaining water is driven off,” that is considered to be close to the claimed range. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). The difference between the claimed range and that taught by Mackay is virtually negligible absent any showing of unexpected results or criticality. One of ordinary skill in the art would have expected the final composition to have the same properties as a composition with the claimed amounts. Therefore, Mackay renders obvious the instant claims.
Mackay teaches that any suitable drying technology will work in the invention [0030], as well as that the grains are subjected to ultrasonic energy to improve the efficiency of the protein extraction [0035]. Mackay does not teach that a radio frequency dryer is used to dry the mixture at a temperature between 70-100 °C for a time between 60-120 minutes.
Jiao, in the same field of invention, teaches drying a food product by a radio frequency dryer at a temperature of 50-80 °C for a time of 20-120 minutes at a frequency of 27.12 MHz (Table 3 p. 113). The temperature taught by Jiao overlaps with the claimed range of 70-100 °C and the time and frequency taught by Jiao encompasses the respective claimed ranges of 60-120 minutes and 15-100 MHz. 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).
Jiao offers the motivation that drying by a radio frequency dryer is a suitable drying means for food applications because it protects the food from being overheated, reduces the variation in moisture content, controls mold growth, and prevents loss of volatile components due to high drying temperature (p. 109). Jiao also provides suitable temperatures, times, and frequency for drying a food product (Table 3 p. 113) where Mackay is silent. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have incorporated the radio frequency dryer and temperatures/times of Jiao into the process of Mackay as the drying step, thereby arriving at the claimed invention. One would have been motivated to make this modification for the benefit of using a dryer that improves the properties of the final food product.
Modified Mackay is silent as to that the fiber content of the product after drying is 20-50% by weight.
However, where the claimed and prior art products are substantially identical in structure or composition, a prima facie case of obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). Since the method and composition of modified Mackay is substantially identical to that of the claimed method and composition, the prior art product must necessarily possess the same properties and characteristics as the composition claimed. Therefore, the composition taught by modified Mackay is considered to possess the fiber content as claimed because the method of making the composition is substantially the same and thus the product made therefrom must necessarily exhibit the same properties.
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Mackay et al. (US PG Pub. 2018/0199593) as evidenced by Kõiv et al. (“Gluten-degrading bacteria: availability and applications,” Applied Microbiology and Biotechnology, 2021, vol. 105, pp. 3045-3059) and in view of Jiao et al. (“Radio-Frequency Applications for Food Processing and Safety,” Annual Reviews of Food Science and Technology, 2018, vol. 9, pp. 105-127), as applied to claim 1 above, and further in view of Stojceska et al. (“The recycling of brewer’s processing by-product into ready-to-eat snacks using extrusion technology,” Journal of Cereal Science, 2008, vol. 47, pp. 469-479; listed on IDS dated Jan. 25, 2022), herein after referred to as Stojceska.
Modified Mackay teaches the method for obtaining a food product as set forth above with regard to claim 1.
Mackay teaches that the brewers spent grains are placed in an enclosed stainless steel tank after collection and prior to further processing [0022].
Modified Mackay does not teach that before adding the enzyme, the waste materials are stored in a container at a temperature below room temperature of 20-25°C for a period not exceeding 48 hours.
Stojceska, in the same field of invention, teaches refrigerating brewers spent grain (i.e., storing waste materials in a container at a temperature below room temperature of 20-25°C) immediately after collection and prior to any further processing (e.g., prior to adding an enzyme). The brewers spent grain is processed the following day (2.1. Preparation of dry BSG) and is therefore considered to be stored for a period less than 48 hours.
Therefore, as it was known in the art to produce a food product from waste materials of beer production, it would have been obvious to have produced a food product with the method as claimed, by modifying the method of modified Mackay, as Stojceska teaches that waste materials are known to be stored in thermally insulated/cooled containers for a period of less than 48 hours prior to further processing.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Mackay et al. (US PG Pub. 2018/0199593) as evidenced by Kõiv et al. (“Gluten-degrading bacteria: availability and applications,” Applied Microbiology and Biotechnology, 2021, vol. 105, pp. 3045-3059) and in view of Jiao et al. (“Radio-Frequency Applications for Food Processing and Safety,” Annual Reviews of Food Science and Technology, 2018, vol. 9, pp. 105-127) and Sureties (GB Application 1909 16651).
As set forth above in the rejection with regard to claim 1, modified Mackay teaches that a flour (Mackay: claim 16) made from brewers spent grain is obtained by the method according to claim 1.
Modified Mackay also teaches that the flour is made from spent barley grains (Mackay: claim 3), thus this flour is considered to be barley malt flour.
Modified Mackay is silent as to that the flour also contains hop flour.
Sureties, in the same field of invention, teaches flour made from spent hops (p. 1 lines 7-10) that is mixed with other flour to produce a food product mixture (p. 1 lines 16-17); Sureties teaches that this mixture contains about 25 wt.% hop flour and about 75 wt.% other material (p. 1 lines 20-21). Sureties offers the motivation that hop flour is useful as a digestive, a poultice, a worm cure, and an appetite stimulant (p. 1 lines 11-15). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have incorporated the hop flour of Sureties into the flour of modified Mackay. One would have been motivated to make this modification for the dietic and medicinal benefits that hop flour possesses.
While Sureties disclose a mixture comprising about 25 wt.% hop flour, the reference is silent with respect to the claimed range of between 1% and 10%. However, where Sureties teaches combining hop flour with other flours and hop flour is known to be used for medicinal purposes, one of ordinary skill in the art would have found in obvious to adjust by no more than routine optimization the amount of added to hops flour used in the flour of modified Mackay to obtain desired medicinal effects while maintaining the sensory properties of the food product 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. Where 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). See MPEP 2144.05.II.A.
As a note, although Sureties does teach mixing the flours, the claim itself is directed to a product, and the patentability of a product does not depend on its method of production, rather the determination of patentability is based on the product itself. See MPEP 2113.I.
Claims 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Awolu et al. (“Antioxidant, function and rheological properties of optimized composite flour, consisting wheat and amaranth seed, brewers’ spent grain and apple pomace,” Journal of Food Science and Technology, 27 Nov. 2015, vol. 53, pp. 1151-1163; listed in IDS dated Jan. 25, 2022), herein after referred to as Awolu, in view of Mackay et al. (US PG Pub. 2018/0199593) as evidenced by Kõiv et al. (“Gluten-degrading bacteria: availability and applications,” Applied Microbiology and Biotechnology, 2021, vol. 105, pp. 3045-3059) and in view of Jiao et al. (“Radio-Frequency Applications for Food Processing and Safety,” Annual Reviews of Food Science and Technology, 2018, vol. 9, pp. 105-127).
Regarding claim 8, Awolu teaches a composite flour (i.e., food product) made from wheat flour, amaranth flour (i.e., cereal flours), and brewers spent grain flour (i.e., flour made from waste materials arising from the production process for producing beer) (p. 1152, left column, last paragraph). Awolu teaches that the composite flour is composed of 65% wheat flour, 30% amaranth flour (total 95% cereal flours), and 2% brewers spent grain flour (Table 2, run 11). The taught amount of cereal flour and brewers spent grain flour lies within the respective claimed ranges of 40-99% by weight and 1-60% by weight.
Awolu does not teach that brewers spent grain flour is obtained with the method according to claim 1.
As set forth above in the rejection with regard to claim 1, modified Mackay teaches that a flour (claim 16) made from brewers spent grain is obtained by the method according to claim 1. Both Awolu and modified Mackay teach a product made from brewers spent grain for use as a flour. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have substituted the brewers spent grain flour of modified Mackay in place of the brewers spent grain flour of Awolu, as the two flours are equivalents known for the same purpose.
Regarding claim 9, Awolu teaches that the cereal flour is a combination of wheat flour and amaranth flour (Tables 1 and 2).
Regarding claims 10 and 11, the claims are met through the rejection of claim 8 as set forth above with regard to cereal flour. Claim 8 requires the selection of cereal flour, vegetable flour, or animal flour; by selecting cereal flour to meet claims 8 and 9, claims 10 and 11 are also considered to be met.
Response to Arguments
Applicant's arguments filed May 11, 2026 have been fully considered but they are not persuasive.
Applicant states that the “examiner appears to be treating Mackay and the claimed invention as a product by process whereby the process is immaterial” and that “the final product is not being claimed – the method is” (Remarks, p. 4). This statement in the arguments is not accurate, as the rejection does in fact compare the process of Mackay to the process of the claimed invention, and rejects it as so. In addition to the claimed process steps, the instant claims also claim properties of the product (e.g., moisture content, fiber content, and particle size), both in the intermediate and final steps. It would be impossible to address these limitations without addressing the product made by the claimed process. Since properties of the product, or an intermediate product, of the claimed process of making the composition are indeed claimed, the product as claimed must, in one way or another, be addressed and examined. The properties claimed are yes, a result of each claimed method step, but the properties themselves are also claimed. Thus, Mackay and the claimed invention are being treated as a process, but the product made therefrom, and the respective properties cannot merely be ignored.
Applicant argues that the focus and intent of Mackay is different from that of the claimed invention, and that this matters because the claimed and prior art products are not substantially identical in structure or composition, the expected fiber content would not be within the claimed amount, and the reason for using an enzyme that breaks down gluten is different (Remarks, p. 5-6).
This argument is not persuasive. The focus and intent of the prior art does not provide a patentable distinction where the prior art teaches the claimed process. The reason for modifying the prior art with another prior art reference also does not need to be the same as applicant’s reason. See MPEP 2144.IV., “the reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant.” Furthermore, applicant argues that the focus of Mackay is producing a protein product, while the focus of the claimed invention is producing a food product with a high fiber content. This is not accurate, as Mackay does also teach a process of producing a fiber flour product (i.e., a fiber food product) as a byproduct of the overall process. Mackay focuses on two processes, one that produces a fiber flour product, and one that produces a protein product. The fiber flour product being a byproduct of the protein product process (Mackay: Fig. 1). Thus, the processes and products are substantially identical, and it could be reasonably presumed, given the rationale previously stated in the rejection above, that the fiber flour product of Mackay would have a fiber content within the claimed range. It remains that applicant has not provided convincing arguments or evidence to the contrary.
Regarding the enzyme, the reason for adding the enzyme, outside of breaking down gluten, does not provide a patentable distinction, where both the cited prior art and the claimed invention add an enzyme that breaks down gluten, and for the same reasons as stated above.
Applicant argues that Mackay does not teach actively cooling in addition to centrifuging to reduce the water content (Remarks, p. 6).
This argument is not persuasive. The instant claims do not require that there is active cooling, and that this active cooling happens at the same time as centrifuging. Mackay certainly teaches centrifuging to reduce the water content, as set forth in the rejection. While Mackay does not teach an active cooling step, there is no limitation in the instant claims that there must be an active cooling step, the claim merely recites “cooling.” Given the broadest reasonable interpretation of the term “cooling,” a step in which a composition/material is heated and then the heat source is removed, is considered to be a “cooling” step since the composition/material will necessarily begin cooling after the heat source is removed. For example, taking a pot of boiling water off of a stove and letting it sit is a sufficient cooling step, as the water will no longer be boiling and will begin to cool after it is moved away from the stove.
In various occasions, applicant argues that the examiner merely tries to “explain away” the differences between the prior art and the instant invention in support of finding the invention obvious (Remarks, p. 4-7).
This argument is not persuasive. The differences are not just “explained away;” the reasons for rendering the instant invention obvious are based upon, and reasoned from, legal precedent, established scientific principles, and/or knowledge generally available to one of ordinary skill in the art, all of which are a sufficient and reasonable basis to render an invention obvious. The rationale is explained sufficiently in the rejections of the claims above.
In the absence of any further arguments with regard to the rejections of the additional dependent claims, the rejections of these dependent claims are maintained.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAURA E SWEENEY whose telephone number is (571)272-0244. The examiner can normally be reached M-F 9:00-6:00 EST.
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/M.E.S./Examiner, Art Unit 1791
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791
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