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 response to the application filed on April 23, 2024. The earliest effective filing date of the application is February 2, 2022.
Priority
The present application is a 371 National Stage Application of PCT/JP2023/001966 which has a filing date of January 23, 2023.
Status of Application
The preliminary amendment filed on April 23, 2024 has been entered. The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1 – 5
Withdrawn claims: None
Currently amended claims: 3 – 5
Claims currently under examination: 1 – 5
Claim Objections
Claim 1 and 3 are objected to because of the following informalities:
Claim 1 recites “a tannase activity per 1 g of the cereal-derived powder is from 0.1 to 60 kU/g.” which should be rewritten to show the tannase activity is kU/g cereal-derived powder. For example, the phrase would be rewritten as “a tannase activity per 1 g of the cereal-derived powder is from 0.1 to 60 kU/g cereal-derived powder.” or “a tannase activity cereal-derived powder.”.
Claim 3 recites “having an ash content of 0.7 mass% or greater” which should be rewritten to distinguish the ash content limitation from the type of cereal-derived powder. For example, “having an ash content of 0.7 mass% or greater” could be rewritten similarly to how the ash content is recited in claim 4: “wherein the cereal-derived powder has an ash content of 0.7 mass% or greater”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 – 5 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “cereal-derived powder” which renders the claim indefinite. The term “derived” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what the metes and bounds of “derived” are intended to encompass. Various types of reactions, for example, may be applied to any molecule present in cereal, such as a sugar, to synthesize a given cereal-derived powder, thereby rendering it derived from cereal. For the purpose of examination, “cereal-derived powder” is interpreted to mean any powder obtained by a physical, chemical, or thermodynamic reaction to any substance present in cereal.
Claims 2 – 5 are rejected as dependent on a rejected base claim.
Claim Rejections - 35 USC § 102/103
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Yao et al. (A novel feruloyl esterase from a soil metagenomic library with tannase activity. Journal of Molecular Catalysis B: Enzymatic. Vol 95. Pp. 55 – 61. (2013)) in view of LibreTexts (19.5: Effect of Concentration on Enzyme Activity. LibreTexts Chemistry. (2021) Retrieved from: https://chem.libretexts.org/Courses/Saint_Francis_University/Chem_114%3A_Human_Chemistry_II_(Muino)/19%3A_Enzymes_and_Vitamins/19.05%3A_Effect_of_Concentration_on_Enzyme_Activity).
Regarding claim 1, Yao teaches a feruloyl esterase with tannase activity, Tan410 (p. 55, paragraph 4). Yao teaches a wheat bran (i.e., a cereal flour composition) comprising:
crude wheat bran (i.e., a cereal-derived powder);
Tan410 (i.e., an enzyme belonging to the tannase family); and
xylanase (p. 59, paragraph 2).
Yao teaches when in combination with xylanase, Tan410 can release ferulic acid from crude wheat bran, like other feruloyl esterases (p. 59, paragraph 3).
Regarding the limitation “a tannase activity per 1 g of the cereal-derived powder is from 0.1 to 60 kU/g”, Yao teaches Tan410 can also hydrolyze methyl gallate, tannic acid, epicatechin gallate, and epigallocatechin gallate, which were used to determine its tannase activity (p. 59, paragraph 7). While Yao is not explicit about the exact tannase activity of Tan410, given Tan410 is able to hydrolyze a broad range of tannins, and is able to release ferulic acid from wheat bran with xylanase, the Tan410 added to the crude wheat bran inherently has a tannase activity of 0.1 to 60 kU/g per 1g of crude wheat bran.
Alternatively, LibreTexts teaches when the concentration of an enzyme is significantly lower than the concentration of the substrate, the rate of an enzyme-catalyzed reaction is directly dependent on the enzyme concentration (p. 1, paragraph 4; Figure 19.5.1, (b)). LibreTexts teaches this is true for any catalyst (i.e., enzyme, such as Tan410); the reaction rate increases as the concentration of the catalyst is increased (p. 1, paragraph 4). Figure 19.5.1 is shown below:
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Part (b) of Figure 19.5.1 shows the effect of enzyme concentration on the reaction rate at a constant level of substrate (p. 1, Figure 19.5.1). Furthermore, the instant specification concurs with this fact in Table 1, wherein an increase in tannase No. 1 linearly increases the enzyme activity across Examples 1 – 8 ([0061]; Table 1). Therefore, the activity of an enzyme when the substrate concentration is constant is a result-effective variable.
While Yao does not teach the activity of Tan410 in the crude wheat bran, one of ordinary skill in the art would have adjusted the concentration of Tan410 in the crude wheat bran, thereby adjusting the activity of Tan410, during routine optimization to find the wheat bran with the desired ferulic acid content balanced with the hydrolyzed tannin content. MPEP §2144.05(II) states 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). The claimed tannase enzyme activity, 0.1 to 60 kU/g, would thus be obvious.
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, 2, and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Yoshida et al. (JP 2015171354 – IDS Filed on March 25, 2026) in view of Yao et al. (A novel feruloyl esterase from a soil metagenomic library with tannase activity. Journal of Molecular Catalysis B: Enzymatic. Vol 95. Pp. 55 – 61. (2013)) and LibreTexts (19.5: Effect of Concentration on Enzyme Activity. LibreTexts Chemistry. (2021) Retrieved from: https://chem.libretexts.org/Courses/Saint_Francis_University/Chem_114%3A_Human_Chemistry_II_(Muino)/19%3A_Enzymes_and_Vitamins/19.05%3A_Effect_of_Concentration_on_Enzyme_Activity).
Regarding claim 1, Yoshida teaches a cereal flour composition comprising:
grain flour (i.e., cereal-derived powder – [0009]); and
free ferulic acid ([0011]).
Yoshida teaches the free ferulic acid is an essential component for imparting excellent dough sagging suppression ability to the cereal flour composition ([0011]).
Yoshida does not teach the cereal flour composition comprises an enzyme of the tannase family.
Yao teaches a feruloyl esterase with tannase activity, Tan410 (p. 55, paragraph 4). Yao teaches a wheat bran (i.e., a cereal flour composition) comprising:
crude wheat bran (i.e., a cereal-derived powder);
Tan410 (i.e., an enzyme belonging to the tannase family); and
xylanase (p. 59, paragraph 2).
Yao teaches when in combination with xylanase, Tan410 can release ferulic acid from crude wheat bran, like other feruloyl esterases (p. 59, paragraph 3). Yao teaches Tan410 can also hydrolyze methyl gallate, tannic acid, epicatechin gallate, and epigallocatechin gallate, which were used to determine its tannase activity (p. 59, paragraph 7).
Yoshida and Yao are combinable because they are concerned with the same field of endeavor, namely, cereal flours comprising ferulic acid. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have added Tan410 and xylanase to the cereal flour composition of Yoshida, as taught by Yao because Tan410 and xylanase are known to release ferulic acid from wheat bran (i.e., provide free ferulic acid to wheat bran, which is a grain flour), thereby imparting desirable dough sagging suppression, and has the added advantage of hydrolyzing tannins.
Regarding the limitation “a tannase activity per 1 g of the cereal-derived powder is from 0.1 to 60 kU/g”, LibreTexts teaches when the concentration of an enzyme is significantly lower than the concentration of the substrate, the rate of an enzyme-catalyzed reaction is directly dependent on the enzyme concentration (p. 1, paragraph 4; Figure 19.5.1, (b)). LibreTexts teaches this is true for any catalyst (i.e., enzyme, such as Tan410); the reaction rate increases as the concentration of the catalyst is increased (p. 1, paragraph 4). Figure 19.5.1 is shown in paragraph 19 above. Part (b) of Figure 19.5.1 shows the effect of enzyme concentration on the reaction rate at a constant level of substrate (p. 1, Figure 19.5.1). Furthermore, the instant specification concurs with this fact in Table 1, wherein an increase in tannase No. 1 linearly increases the enzyme activity across Examples 1 – 8 ([0061]; Table 1). Therefore, the activity of an enzyme when the substrate concentration is constant is a result-effective variable.
While Yoshida does not teach the activity of Tan410 in the cereal flour composition, one of ordinary skill in the art would have adjusted the concentration of Tan410 in the crude wheat bran, thereby adjusting the activity of Tan410, during routine optimization to find the cereal flour composition with the desired ferulic acid content balanced with the hydrolyzed tannin content. MPEP §2144.05(II) states 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). The claimed tannase enzyme activity, 0.1 to 60 kU/g, would thus be obvious.
Regarding claim 2, while Yoshida does not teach the concentration of Tan410 in the cereal flour composition, one of ordinary skill in the art would have adjusted the concentration of Tan410 in the crude wheat bran, thereby adjusting the activity of Tan410, during routine optimization to find the cereal flour composition with the desired ferulic acid content balanced with the hydrolyzed tannin content. MPEP §2144.05(II) states 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). The claimed tannase enzyme concentration, 10 to 10000 ppm, would thus be obvious.
Regarding claim 5, Yoshida teaches the cereal flour composition may be combined with water to form a dough, which is then used to form a food product (i.e., a dough food product – [0019]).
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Yoshida et al. (JP 2015171354 – IDS Filed on March 25, 2026) in view of Yao et al. (A novel feruloyl esterase from a soil metagenomic library with tannase activity. Journal of Molecular Catalysis B: Enzymatic. Vol 95. Pp. 55 – 61. (2013)) and LibreTexts (19.5: Effect of Concentration on Enzyme Activity. LibreTexts Chemistry. (2021) Retrieved from: https://chem.libretexts.org/Courses/Saint_Francis_University/Chem_114%3A_Human_Chemistry_II_(Muino)/19%3A_Enzymes_and_Vitamins/19.05%3A_Effect_of_Concentration_on_Enzyme_Activity), as applied to claim 1 above, and further in view of Mlinotest (What do the Type and Strength of the Flour Mean? Mlinotest 1867. (2021) Retrieved from: https://www.mlinotest.si/wp-content/uploads/2021/03/type-and-strength-of-flour.pdf).
Regarding claims 3 and 4, Yoshida teaches the grain flour (i.e., cereal-derived powder) is, for example, durum wheat flour (i.e., a cereal flour other than wholemeal flour – [0009]).
While Yoshida is silent with respect to the ash content of the durum wheat flour, Mlinotest teaches a durum wheat flour comprising 0.9 to 2.0 wt% ash (p. 1, Slovenian Regulation on the quality of cereal products defines the following types, wheat durum flour).
Yoshida and Mlinotest are combinable because they are concerned with the same field of endeavor, namely, durum wheat flour. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have selected the durum wheat flour of Mlinotest as the durum wheat flour in the cereal flour composition of Yoshida because Mlinotest provides that it was known for durum wheat flour comprising 0.9 to 2.0 wt% ash to exist at the time of filing, which means it was within the general skill of a worker in the art to select the durum wheat flour comprising 0.9 to 2.0 wt% ash as the durum wheat flour in the cereal flour composition of Yoshida, because it would be obvious to one of skill in the art to do such a thing on the basis of its suitability for a similar intended use. See MPEP § 2144.07.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LARK JULIA MORENO whose telephone number is (571)272-2337. The examiner can normally be reached 6:30 - 4:30 M - F.
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/L.J.M./Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793
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