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 .
Election/Restriction
Applicant’s election of group I in the reply filed on 10/16/2025 is acknowledged. It is noted that group I encompasses claims 1-7 and 10-13. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
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”).
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.
Matti et al. teaches phenolic acids present in cereal malts (abstract), where DIMBOA-hex or DIMBOA-hex-hex are present in beverages such as wheat beer (page 401 figure 1; page 405 Table 2). The reference also teaches the concentration of benzoxazinoids 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 in order 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, and to combine prior art elements according to known methods to yield predictable results in substance quantification.
Regarding the concentration of the DIMBOA component, 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 values in the malted wheat of the prior art cited above. Further, duration of processing and variety of wheat used would have been expected to have a result on the DIMBOA content of the final malted wheat. It would have been obvious to one of ordinary skill in the art to modify the malted wheat to have the claimed DIMBOA concentration 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. Therefore, it would have been further obvious to modify the amount of the components to obtain the claimed effect for the same reasons. 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 argument, see page 11, filed 10/16/2025, with respect to the rejection of claim 1 under 35 USC 112(b) has been fully considered and are persuasive. The rejection has been withdrawn.
Applicant’s arguments, see pages 12-13, with respect to the rejection of claim 1 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, new grounds of rejection are made in view of Cambier et al., which explicitly teaches DIMBOA-glc (hex) concentration is elevated after germination and increases for a period of time afterward.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRYAN KIM whose telephone number is (571)270-0338. The examiner can normally be reached 9:30-6.
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If attempts to reach the examiner by telephone are unsuccessful, the 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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/BRYAN KIM/Examiner, Art Unit 1792