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 .
The amendment filed November 7, 2025 has been entered. Claims 1-20 are pending.
The previous rejection of claims 3-10 and 15-19 under 35 U.S.C. 112(b) have been withdrawn in light of Applicant’s amendment and remarks filed November 7, 2025.
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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Rood et al. (“Control of microbes on barley grains using peroxyacetic acid and electrolysed water as antimicrobial agents”, Food Microbiology, 56, (2018), pp. 103-109). in view of Vaddu et al. (“Impact of pH on efficacy of peroxy acetic acid against Salmonella, Campylobacter, and Escherichia coli on chicken wings”, Poultry Science, Volume 100, Issue 1, (January 2021), pp. 256-262).
Regarding claims 1, 3-6, 12-14, Rood et al. disclose a method of treating barley grains to control microbial growth during the malting process, the method comprising the steps of: (a) obtaining malting grade barley (b) treating the malting grade barley with a solution (100 or 500 ppm) of peroxyacetic acid (PAA)(i.e., peroxyacid) and hydrogen peroxide for 30 minutes (i.e., pre-steep wash – p. 104/Column 2/1. Introduction, 2. Material and methods).
Rood et al. disclose germinating the grains (p. 105/Column/2.5 Germination test).
Given Rood et al. disclose a sanitizing solution comprising peroxyacetic acid and hydrogen peroxide, identical to the claimed sanitizing solution, and wherein the pH has not been adjusted, inherently the pH of the sanitizing solution would fall within the claimed range of
5-12.
Moreover, Vaddu et al. teach the impact of pH on efficacy of peroxyacetic acid (PAA) against microbial contamination (e.g., Salmonella, Campylobacter and Escherichia. coli – Abstract). Vaddu et al. teach the natural pH of PAA is between 4.5 and 6 (Abstract). Vaddu et al. teach increasing the pH of PAA solutions (pH 8.2 and 10) did not affect its efficacy against bacteria on chicken wings (Abstract).
Vaddu et al. and Rood et al. are combinable because they are concerned with the same field of endeavor, namely reducing harmful microorganisms on foodstuff by treating with peroxyacid compositions. It would have been obvious to one of ordinary skill in the art to have treated the malting grade barley of Rood et al. with a sanitizing solution comprising PAA and having a pH at either its natural pH or elevated pH’s, including from pH 8-10, as taught by Vaddu et al, and obtain a malted barley with a reduced presence of harmful microorganisms.
Rood et al. disclose when grain infected with filamentous fungi was treated with 500 ppm PAA the infection was reduced to less than 50% (p. 106/Columns 1-2/3.3 Antimicrobial efficacy of PAA). While Rood et al. is silent with respect to the reduction of deoxynivalenol (DON), given DON is a toxin produced by filamentous fungi, Fusarium (as disclosed in the specification of the instantly claimed invention- p.), since Rood et al. disclose treating malting grade barley with a sanitizing solution of peroxyacetic acid and hydrogen peroxide to reduce filamentous fungi, inherently the treatment would be effective at reducing the amount of DON in the malting barley to a level in the claimed range.
Regarding claims 2 and 15, modified Rood et al. disclose all of the claim limitations as set forth above. Rood disclose treating the malting grade barley with a sanitizing solution of peroxyacetic acid (PAA)(i.e., peroxyacid) and hydrogen peroxide for 30 minutes as part of a pre-steep wash step, absent evidence to the contrary, it would have been obvious to one of ordinary skill in the art to have treated the malting grade barley at any step in the malting process, including during steeping, and arrive at the present invention. Selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results (MPEP §2144.04 IV.C.).
The combination of Rood et al. and Vaddu et al. teach using the PAA at a pH of 8 or 10.
Regarding claims 7 and 16, modified Rood et al. disclose all of the claim limitations as set forth above. Given Rood et al. disclose steps of prewashing and germination, the limitations of claims 7 and 16 are satisfied. Claim 3, from which claims 7 and 16 are ultimately dependent upon, does not require steeping.
Regarding claims 8 -10 and 17-19, modified Rood et al. disclose all of the claim limitations as set forth above. While Rood et al. disclose the sanitizing solution has a concentration of 100 or 500 ppm peroxyacetic acid, the reference is silent with respect to ICT.
Given Rood et al. disclose a concentration of peroxyacid and treatment time substantially similar to that of the presently disclosed invention, it necessarily follows the treatment would be conducted at an ICT in the range presently claimed.
Regarding claims 11 and 20, modified Rood et al. disclose all of the claim limitations as set forth above. Given Rood et al. disclose treating malting grade barley with PAA at 100 and 500 ppm reduces Pseudomonas spp. heterotrophic bacteria yeasts and filamentous fungi (Abstract), since Rood et al. disclose a treatment with PAA substantially similar to that of the presently disclosed invention, it necessarily follows the treatment would be for a period sufficient to reduce total microbial count (APC) or a yeast and mold count (YM) by at least 80%.
Response to Arguments
Applicant's arguments filed November 7, 2025 have been fully considered but they are not persuasive.
Applicants submit “there is no motivation to combine Rood and Vaddu to arrive at the claimed invention.” Applicants argue “[a] person of ordinary skill in the art (POSA), when faced with the problem of reducing fungal mycotoxins (like DON) during the malting of viable grains, would not have been motivated to a look to a reference concerning the bacterial decontamination of poultry meat for a solution.”
In order for a reference to be proper for use in an obviousness rejection under 35 U.S.C. 103, the reference must be analogous art to claimed invention (MPEP §2144.01(a)). In response to applicant's argument that Vaddu et al. is 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, Vaddu et al. is in the same field of endeavor as Rood et al. and the claimed invention. Rood et al. is directed to controlling microorganisms on barley grains using peroxyacetic acid. Vaddu et al. is directed to the impact of pH on the efficacy of peroxyacetic acid for controlling microorganisms on chicken wings. Both references are directed to controlling microorganisms in food matrices. One of ordinary skill in the art would have reasonably looked to Vaddu et al. to understand the effect of pH on the efficacy of peroxyacetic acid for controlling microorganisms generally.
Applicants submit “Vaddu teaches away from the claimed invention.” Applicants explain “Vaddu explicitly states PAA is a weak acid with a pKa of 8.2 and that at higher pH values, it exists in a dissociated form that “cannot penetrate the cell membrane,” which is the “main mechanism of action for inactivation of microorganism [sic] by weak organic acids”.
While the Introduction section of Vaddu et al. discusses why raising the pH of a PAA solution to above its pKa of 8.2 is thought to be ineffective at inactivating microorganisms, the reference presents data to show that raising the pH from 8.2 to 10 did not affect the antimicrobial activity of PAA.
Applicants submit the “assertation that Rood’s process “inherently” reduced DON to the claimed level of less than 0.6 mg/kg is speculative and improper.”
Here, Rood et al. disclose a method of treating barley grains to control microbial growth during the malting process, the method comprising the steps of: (a) obtaining malting grade barley (b) treating the malting grade barley with a solution (100 or 500 ppm) of peroxyacetic acid (PAA)(i.e., peroxyacid) and hydrogen peroxide for 30 minutes (i.e., pre-steep wash – p. 104/Column 2/1. Introduction, 2. Material and methods). Rood et al. disclose a process substantially similar to that presently claimed including treating barley with a PAA having a concentration overlapping the range disclosed in the present invention (250 – 5000 ppm peroxyacid (p. 2/L25-35) and for a time overlapping the range disclosed in the present invention (i.e., at least 5 minutes or 5 minutes to 60 minutes – p. 3/L1-8). The assertion of inherency is not speculative.
Rood et al. disclose when grain infected with filamentous fungi was treated with 500 ppm PAA the infection was reduced to less than 50% (p. 106/Columns 1-2/3.3 Antimicrobial efficacy of PAA). While Rood et al. is silent with respect to the reduction of deoxynivalenol (DON), given DON is a toxin produced by filamentous fungi, Fusarium (as disclosed in the specification of the instantly claimed invention- p.), since Rood et al. disclose treating malting grade barley with a sanitizing solution of peroxyacetic acid and hydrogen peroxide to reduce filamentous fungi, inherently the treatment would be effective at reducing the amount of DON in the malting barley to a level in the claimed range.
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 ELIZABETH A GWARTNEY whose telephone number is (571)270-3874. The examiner can normally be reached M-F: 9 a.m. - 5 p.m. EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Duane Smith can be reached at 571-272-1166. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
ELIZABETH A. GWARTNEY
Primary Examiner
Art Unit 1759
/ELIZABETH GWARTNEY/Primary Examiner, Art Unit 1759