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 .
Claim Objections
Claim 5 is objected to because of the following informalities:
In line 2 delete “is/are ferulic acid and/or vanillic acid and/or sinapic acid” and insert “are selected from the group consisting of ferulic acid, vanillic acid and sinapic acid” for consistency with the language of claim 1 limitation (i).
Appropriate correction is required.
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, 3-7, 10-13 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Langos et al. “Development of stable isotope dilution assays for the quantitation of free phenolic acids in wheat and barley and malts produced thereof”, hereon referred to as “Langos et al.” in view of Matti Pihlava et al. “Determination of benzoxazinoids in wheat and rye beers by HPLC-DAD and UPLC-QTOF MS”, hereon referred to as “Matti et al.”, and Cambier et al. “Variation of DIMBOA and related compounds content in relation to the age and plant organ in maize”, hereon referred to as “Cambier et al.”
Regarding claim 1, Langos et al. teaches malted wheat (page 638 “Grain and malt samples”) comprising ferulic, vanillic and sinapic acids (page 643 table 3), where the concentration of said acids remarkably increased during wheat malt production (page 641 “Quantitation of free phenolic acids in wheat, barely, and malts produced thereof”). Therefore, the concentration of the above compounds would have been higher than non-malted wheat.
Langos et al. does not teach the malted wheat comprises the components recited by limitation (ii), hereon referred to as “DIMBOA-hex” and “DIMBOA-hex-hex”, respectively, at the claimed concentrations, measured by UPHLC-MS/MS analysis as claimed. For the sake of examination, the alternative “DIMBOA-hex” is chosen.
Matti et al. teaches phenolic acids present in cereal malts (abstract), where DIMBOA-hex is present in beverages such as wheat beer (page 401 figure 1; page 405 Table 2). The reference also teaches the concentration of benzoxazinoids, such as DIMBOA, increases during malting/germination of rye and wheat grains (page 401 left column).
While Langos et al. does not recite measuring DIMBOA by the claimed method, the reference still teaches using HPLC-MS/MS analysis with water dilution assays to quantify the desired acid components (page 639 right column). Therefore, quantification of DIMBOA-hex or DIMBOA-hex-hex using a known analysis method would have been prima facie obvious as a matter of preference and/or availability of a particular method and/or analysis device, to adjust sample concentration for a particular analysis device as is known in the art for dilution assays, and to combine prior art elements according to known methods to yield predictable results in substance detection and quantification.
Regarding the concentration of DIMBOA-hex, the prior art recognizes that malting increases the concentration of benzoxazinoids, including DIMBOA.
Cambier et al. teaches DIMBOA-Glc (DIMBOA-hex) concentration “increases abruptly” after germination (page 224 left column), where the concentration is 11.7 mmol/kg fresh weight and 12.9 mmol/kg fresh weight depending on variety, and the concentration was found to increase after germination (page 224 section 2.1; figure 2a, 2d, 2f, and 2i).
Absent persuasive evidence to the contrary, one of ordinary skill in the art would have reasonably expected similar concentration increase in the malted wheat of Langos et al. above. Further, duration of processing and variety of wheat used would have been expected to affect the DIMBOA content of the final malted wheat.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the malted wheat of Langos et al. to have the claimed DIMBOA-hex concentration since the prior art recognizes malting/germination causes a significant increase in DIMBOA concentration, since the evidence of record does not indicate criticality or unexpected results associated with the claimed features, and since the claimed values would have been used during the course of routine experimentation and optimization procedures due to factors such as those associated with malting as is known in the art.
Regarding claims 3-4, the combination applied to claim 1 above teaches malted wheat (a food product) comprising the claimed substances and renders obvious the claimed concentrations.
It would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the amount of the claimed components to obtain the claimed effect for the same reasons stated for claim 1. Additionally, a compound and its properties are inseparable, In re Papesch, 137 USPQ 43 (CCPA 1963), and therefore one of ordinary skill in the art would have expected to observe similar effects at the claimed concentrations.
Regarding claim 5, Langos et al. teaches the recited acids as stated for claim 1.
Regarding claims 6-7, Langos et al. teaches malted wheat and Matti et al. teaches malting increases benzoxazinoids as stated for claim 1. Matti et al. further teaches wheat contains DIBOA and hexose derivatives, where the amount of DIBOA is lower than that of DIMBOA (table 2 “found” column).
Absent evidence to the contrary, one of ordinary skill in the art would have expected DIBOA and DIMBOA to be present the same relative concentrations in the malted wheat of Langos et al.
Regarding claims 10-11 and 18, the type of wheat claimed e.g., Festival and Stava, are known varieties. It would have been obvious to one of ordinary skill in the art to use the claimed wheat type since there is no evidence of criticality or unexpected results, and therefore as a matter of manufacturing preference and desired flavor, texture/mouthfeel, aroma and nutritional profile of the final product.
Regarding claim 12, the malted wheat taught by Langos et al. is edible, and therefore construed to be a type of “food, feed, a food supplement and/or a nutraceutical”.
Regarding claim 13, the combination above teaches a product that appears to have the same composition as that of the claimed product. Absent persuasive evidence to the contrary, one of ordinary skill in the art would have reasonably expected the product of the prior art combination to have similar effects to that of the claimed composition.
Response to Arguments
Applicant's arguments filed 7/1/2026 have been fully considered but they are not persuasive.
Applicant argues the experiments reported in Cambier were conducted in maize, not wheat as claimed, and would have had no reasonable expectation that malting wheat would produce the same outcome. Applicant argues one of ordinary skill would not have extrapolated the results to wheat since i) the benzoxazinoid biosynthetic pathway is not fully conserved between wheat and maize, where wheat orthologs of maize biosynthetic genes Bx7 and Bx10-Bx14 have not been identified, and one of ordinary skill would have no basis to assume the compounds produced during maize malting would be produced in equivalent fashion during wheat malting, ii) species-specific differences in benzoxazinoid profiles are well established, where species and tissue specific variation makes clear that an observed increase in a particular compound during maize malting cannot reliably predict the outcome of wheat malting, iii) the double-hexose derivatives are biologically and chemically distinct, where the enzymatic machinery for said compounds has only recently been characterized and there is no basis to predict the specific enzymes required to produce di-hexose conjugates in maize would function comparably or be present in wheat, and iv) wheat-specific transcriptional regulation is distinct and was not understood at the time of the invention, where one of ordinary skill would have lacked any principled basis to predict that wheat would respond to the stress of malting in the same manner as maize.
Regarding argument i), the prior art recognizes “the content of benzoxazinoids increases during germination of rye and wheat grains” as taught by Matti et al. (page 401 left column), where DIMBOA-hex is recognized to be part of the group of benzoxazinoids (page 405 table 2 “benzoxazinoids”). Regarding Cambier, the reference is not relied on to show a direct relationship between DIMBOA-hex concentration increase in maize and wheat. Rather, the reference is cited to teach that “after germination, [DIMBOA] concentration in the plant increases abruptly reaching a maximum and then decreases progressively with plant age” in cereal seeds (page 224 left column). Further, Cambier also teaches wheat contains “hydroxamic acids in high concentrations…depending on varieties and conditions” (page 223 left column), where hydroxamic acids include DIMBOA (abstract). This suggests to one of ordinary skill that DIMBOA concentration in such cereal seeds (including wheat) is a result effective parameter based at least on variety, germination conditions, and age. While the benzoxazinoid pathway may not be fully conserved between wheat and maize, the two are still recognized by the art to be Poaceae that yield increase DIMBOA concentration when malted. Thus, absent evidence of unexpected results or criticality associated with the claimed malted wheat, one of ordinary skill in view of the cited prior art would have reasonably expected similar “abrupt” increase DIMBOA concentration in malted wheat, the concentration depending at least one the parameters stated above. Applicant has not shown evidence of criticality or unexpected results, further explained below.
Additionally, Examiner notes Song et al. (WO 2008/099013 A1) teaches monocotyledonous plants such as wheat (page 91 line 33) can be modified to produce DIMBOA for the advantage of resistance to European corn borer, rootworm and several other insect pests, where “candidate genes that are particularly considered for use in this regard include those genes at the bx locus known to be involved in the synthetic DIMBOA pathway” (page 94 lines 5-11). Thus, the prior art suggests that bx genes were known to be related to DIMBOA production, and provides motivation to modify wheats to produce DIMBOA for the advantages taught by Song et al.
Regarding argument ii) significant increases in DIMBOA concentration is expected for malted wheat as stated above. The evidence of record does not indicate criticality or unexpected results associated with the claimed malted wheat. The closest evidence provided appears to be example 4 table 4 (page 33), which discloses wheat malted under certain conditions. Additionally, the specification discloses DIMBOA concentration increases when the wheat is subjected to, generically, “the malting process as described herein” (page 31 lines 13-14 and 27-28). However, there is no comparison to wheat malted by any other method, including those known in the art. One of ordinary skill would not have been able to determine from the data whether the disclosed conditions are critical to obtaining the claimed DIMBOA concentrations, and if the claimed concentrations cannot be obtained by any generic malting process.
Regarding argument iii), Examiner notes claim 1 recites the limitation “and/or” with respect to the concentration of DIMBOA-hex and DIMBOA-hex-hex. The limitation indicates alternatives, where DIMBOA-hex is chosen for examination, and therefore the concentration of DIMBOA-hex-hex is construed to be optional. The cited prior art recognizes DIMBOA-hex as part of benzoxazinoid compounds in wheat, the concentration of which increases during malting as stated above.
Regarding argument iv), while wheat-specific transcriptional regulation may indeed be distinct and not understood at the time of the invention, the cited prior art still suggests to one of ordinary skill that DIMBOA concentration in wheat significantly increases during malting. Applicant has not shown sufficient evidence that the claimed malted wheat is different from that of known malted wheat, and that the disclosed malting parameters are critical to obtain the claimed DIMBOA concentrations. Since DIMBOA concentration is recognized by the prior art to increase during malting and a result effective parameter based on germination, variety, and age of the plant, one of ordinary skill would have reasonably expected a malted wheat to have the claimed concentration based on routine experimentation and optimization of the above features.
Applicant’s argument against the dependent claims is not persuasive for the same reasons stated above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Song et al. (WO 2008/099013 A1) teaches monocotyledonous plants such as wheat (page 91 line 33) can be modified to produce DIMBOA for the advantage of resistance to European corn borer, rootworm and several other insect pests, where “candidate genes that are particularly considered for use in this regard include those genes at the bx locus known to be involved in the synthetic DIMBOA pathway” (page 94 lines 5-11).
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.
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/B.K/Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792
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