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 .
DETAILED ACTION
2. Applicants’ arguments and amendments filed on 8/25/2025, have been fully considered but are not persuasive. Therefore, the following action is final.
Any objections and/or rejections made in the previous action, and not repeated below, are hereby withdrawn.
Status of the application
3. Claims 1 and 3-10 are pending in this office action.
Claims 1,3,8 and 10 have been amended.
Claim 2 has been cancelled.
Claims 1 and 3-10 have been rejected.
Claim Rejections - 35 USC § 103
4. 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.
5. 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.
6. 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 non-obviousness.
7. Claims 1, 3-5, 7-10 are rejected under 35 U.S.C. 103(a) as being unpatentable over Kino et al. (JP 2014082976 A) in view of Ito et al. (KR 20160130211 A; 2016-11-10) and further in view of NPL Hellwig et al. (in J. Agric. Food Chem, 64: pages 7234-7243, 2016).
8. Regarding claim 1, 4, 5, 7-10, Kino et al. discloses a flavor improving agent for beer-like beverage and this “flavor-improving agent” is added to a beer-like beverage for which the flavor is to be improved is a beer-like non-alcoholic beverage (at least in claims 1-6 of Kino et al.).
Kino does not specifically mention the claim limitation of
(a) “a grain-derived protein” as claimed in claims 1, 7 and 8.
(b) “a glycated protein which is grain-derived protein has a ‘glycated amino group of lysine’, and has a molecular weight of 3 to 50 kDa” as claimed in claims 1,7 and 8.
With respect to (a), it is to be noted that Kino et al. also discloses that the flavor improvement method of a beer flavor drink characterized by adding the flavor improving agent for the beer flavor drink to make beer-flavored beverage wherein the beer-flavored beverage is a non-alcohol beer-flavored beverage (at least in claims 6,7 of Kino et al.) to meet claim limitation of “having an alcohol content of less than 1.0% “as claimed in claims 1, 7-10.
Regarding grain-derived protein, it is to be noted that grain is used for such a process as disclosed by Kino et al. (i.e., starch hydrolyzed) (Under Background-art, paragraphs 2, 3, Under “TECH-SOLUTION, paragraph 8) in making such a beer-flavored alcohol. Even if it is in background section, however, this disclosure is considered because it is known and as disclosed by other prior arts of record (i.e., as mentioned in Background section) that grain is used in such a process.
Examiner has considered Ito et al. to link Ito’s teaching that grain-derived protein degradation product can be incorporated into such non-fermented (i.e., non-alcoholic) beer (at least on page 5, paragraph 6). Ito et al. also discloses that the grain can be barley, wheat, corn or soybean (at least on page 5, paragraphs 6, 7) to meet claim 5.
As mentioned above, Kino’s disclosure has (i) flavor improving agent for beer-like beverage obtained by freeze-drying a beer-like alcohol containing liquid produced by a fermentation step and (ii) a beer-like beverage for which the flavor is to be improved is a beer-like non-alcoholic beverage (at least in claims 1-6 of Kino et al.). Therefore, non-alcoholic beverage can be non-fermented beer or diluted fermented beer which is sufficiently diluted to make minimal (<1% alcohol). Therefore, non-alcoholic beverage can be non-fermented beer or diluted fermented beer which is sufficiently diluted to make minimal (<1% alcohol). Therefore, Kino and Ito are combinable.
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Kino et al. with the teaching of Ito et al. to make the flavor improving agent” from grain derived protein obtained by freeze-drying a beer-like alcohol containing liquid produced by a fermentation step in order to add into non-alcoholic beer of Kino et al. because it provides further enhancement of feeling of satisfaction felt in the neck when added to the non-fermented beer flavored beverage drink and it provides additionally bubble retention effect (i.e. looks like natural beer) in the final product as taught by Ito et al. ((at least on page 5, paragraph 6).
Therefore, one of ordinary skill in the art would have been motivated to make “the flavor improving agent” from grain derived protein in order to add into non-alcoholic beer of Kino et al. with a reasonable expectation of success to have further enhancement of feeling of satisfaction felt in the neck when drinking non-fermented beer flavored beverage with an additional bubble retention effect (i.e. looks like natural beer) in the final product as taught by Ito et al. ((at least on page 5, paragraph 6).
With respect to (b) NPL Hellwig et al. discloses that such product is in glycated form with amino acids including lysine with the sugar (moiety) bound form (glucose, maltose etc.) in a peptide-bound form (at least in page 7237, col 2 last paragraph) which includes peptide >14 kDa (page 7239 col 1 under “Protein bound MRPs in Beer, 5th line). Therefore, it meets claim 4.
NPL Hellwig et al. also discloses the method of isolating /separating specific size and specific glycated protein fragment having desired degree of glycation (at least in page 7237 col 2 last paragraph, page 7239 col 1 under “Protein bound MRPs in Beer, 5th line) in order to its use in a proportionate amount for having desired concentration for different type of beer. Therefore, NPL Hellwig et al. discloses the flavor enhancing agent including lysine glycated product can be made to be used to enhance the desired specific flavor for specific type of beer. It is also to be noted that the disclosed >14 kDa (page 7239 col 1 under Protein bound MRPs in Beer). In the case 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Kino et al. in view of Ito et al. with the teaching of NPL Hellwig et al. to make “a glycated protein having glycated amino group of lysine” in order to serve as desired flavor enhancing property , color etc. in different type of beer” (at least in page 7237 col 2 last paragraph, page 7239 col 1 under “Protein bound MRPs in Beer, 5th line and Table 6). However, the amount of glycation and size (MW) are optimizable and discussed below.
It is also to be noted that the method comprising disclosed identical flavor enhancing agent which is identical to the claimed flavor enhancing agent having glycated protein including 30-35 kDa MW containing glycated amino group of lysine, therefore, the disclosed method containing identical flavor enhancing agent will have identical enhancement of rich flavor as claimed in claim 8 and will perform identical “sour flavor reducing property” as claimed in claims 1, 9 and the method of reducing sour flavor is “sour flavor reducing method” as claimed in claim 10.
9. Regarding amended claims 1, 10 and claim 3, it is to be noted that even if Kino et al. specifically does not mention the claim limitations of claims 1, 10 and claim 3, however, it is within the skill of one of ordinary skill in the art would have been motivated consider the flavor improving agent having the presence of peptide fragment having sufficient lysine which takes part in glycation in order to have the presence of glycated protein fragment having MW 35 kDa to 50 kDa and having glycated lysine content more than 4.7 nmol/ml as claimed in amended claims 1, 10 and greater than 9.4 nmol/ml or more as claimed in claim 3. One of ordinary skill in the art would have been motivated to consider the specific glycated protein with the glycated amino group of lysine having MW 35 kDa to 50 kDa and having glycated lysine content more than 4.7 nmol/ml, greater than 9.4 nmol/ml or more with reasonable expectation of success to make desired rich flavor improving effect of the final non-alcoholic beer in spite of its absence/minimal, less than 1% of alcohol. This amount of glycation as claimed in claims 1,3 and 10 are optimizable.
Absent showing of unexpected results, the specific amount of glycation and size of MW is not considered to confer patentability to the claims. As the taste, texture are variables that can be modified, among others, by adjusting the amount of glycation and size of the glycated protein, the precise amount would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the amount of glycated lysine in the peptide having 35-50 kDa size in Kino et al., to amounts, including that presently claimed, in order to obtain the desired effect e.g. desired enriched beer-taste flavor (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
10. Claim 6 is rejected under 35 U.S.C. 103(a) as being unpatentable over Kino et al. (JP 2014082976 A) in view of Ito et al. (KR 20160130211 A; 2016-11-10) and further in view of NPL Hellwig et al. (in J. Agric. Food Chem, 64: pages 7234-7243, 2016) as applied to claim 4 and further in view of Nakamori et al. (EP 1840201A1).
11. Regarding claim 6, Kino is silent about “beverage contains no wort”.
Nakamori et al. discloses that such a product containing “flavor enhancing agent” when diluted to make a beverage, wort is diluted to have its presence as nil after dilution or not used ([0048]).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Kino et al. with the teaching of Nakamori et al. discloses that such a product containing “flavor enhancing agent” when diluted to make a beverage, wort is diluted to have its presence as nil after dilution or not used ([0048]) to make beer-taste beverage without wort.
Response to Arguments
12. Applicants argued on first page “ As demonstrated in Table 1 (see paragraph [0053]) of the specification, when the content of glycated lysine in a non-alcoholic beer-taste beverage 1s 4.7 nmol/mL or more, sour flavor is reduced, and when the content of glycated lysine in a non-alcoholic beer-taste beverage is 9.4 nmol/mL or more, rich flavor is enhanced”.
In response, it is to be noted that and as discussed in the office action above that it is within the skill of one of ordinary skill in the art to consider the teaching of NPL Hellwig et al. (The flavor enhancing agent including lysine glycated product having >14 kDa MW (at least pages 7235 col 1 and 7239 col 1 ) to optimize the amount of glycated protein fragment having glycated lysine content more than 4.7 nmol/ml or greater than 9.4 nmol/ml within the claimed peptide fragment having MW 35 kDa to 50 kDa in order to establish the desired sour reduction with enriched flavor in the product.
Examiner has also considered applicants arguments about the criticality of the abovementioned content of glycated lysine in a non-alcoholic beer-taste beverage as demonstrated in applicant’s specification (in PGPUB, Table 1 ([0053]) to establish unexpected result above is acknowledged and is considered.
However, the arguments are insufficient to overcome the final rejection because:
(a) Applicants have not established the criticality of the amounts of glycated lysine which is claimed amount of greater than 4.7 nmol/mL or more as claimed in claims 1, 10.
(b) This can be established by comparing the claimed invention to the teachings of the closest prior art reference by Hellwig et al..
(c) Evidence of unexpected results must be commensurate in scope with the subject matter claimed. In re Linder 173 USPQ 356. More importantly, the evidence of unexpected results must be clear and convincing. In re Lohr 137 USPQ 548. To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside (i.e. as well as the upper and lower limits) the claimed range to show the criticality of the claimed range. In re Hill 284 F.2d 955, 128 USPQ 197 (CCPA 1960). See MPEP 716.02.
In this instance, applicants have demonstrated the effect of glycated lysine containing peptide have glycated lysine content is more than 4.7 nmol/ml or more than 9.4 nmol/ml (in PGPUB, Table 1 ([0053]). However, there is no outside value, specifically, immediately below 4.7 nmol/ml by which the criticality of 4.7 nmol/ml can be established.
Therefore, the unexpected result is not sufficient to establish the criticality of the data which commensurate with the scope of the claimed invention.
13. Applicants argued in remarks, on second page, first paragraph that “Kino does not disclose a flavor improving agent obtained by freeze-drying a beer-like alcohol containing liquid produced by a fermentation step. It appears that the Examiner is referring to Kishimoto et al. (JP2013-201976), included in the IDS, rather than Kino. It is respectfully submitted that the Examiner confirm the document number. If the document number was incorrect, the Examiner is requested that any subsequent office action not be final”.
In response, it is to be noted that Kino et al. discloses a flavor improver” (at least in claims of Kino et al. ; each claim recites “A flavor improving agent”: although claims are not numbered, eight paragraphs indicate eight claims ) and it also recites “fermenting it” (at least in fourth paragraph i.e. claim 4 of Kino et al.) and it can be non-alcohol beer-flavored beverage (at least in seven and eight paragraph i.e. claims 7-8 of Kino et al.). It is also to be noted that examiner has considered Kino et al. (JP 2014/082976 A) as primary prior art in the last office action mailed on 3/24/2025. Accordingly, Kino et al. (JP 2014/082976 A) is recorded in PTO-892 on 3/24/2025 under FOR reference and the translated English version is posted on 3/24/2025.
Regarding “freeze-drying”, Kino et al. discloses that the obtained fermented hop extract which is a taste improving agent is freeze-dried (at least on page 4, paragraph 6 and claims 4,5 of Kino et al.). However, independent claim does not claim “freeze-drying” in the claimed invention. Therefore, examiner is deleting “freeze-drying from the above office action (item #1), yet maintaining the finality of the office action.
14. Applicants argued in remarks, on second page, last but one paragraph that
(i) “Hellwig discloses that Maillard reaction positively influences the foaming properties of certain barley proteins (page 7235, left column, the second paragraph), but it does not teach influences of a glycated lysine on sour flavor or rich flavor and
(ii) Hellwig does not suggest that a lysine glycated product can be used to reduce sour flavor or enhance rich flavor. Accordingly, these effects are unpredictable from Hellwig”.
In response to (i) and (ii), it is to be noted that NPL Hellwig et al. also discloses that “a glycated protein having glycated amino group of lysine” positively influences flavor, color and foaming properties of certain barley proteins (at least in page 7235 col 1 second paragraph lines 7-9, 12-14 and also in page 7237 col 2 last paragraph, page 7239 col 1 under “Protein bound MRPs in Beer, 5th line and in Table 6 it recites “ enhancing property in different type of beer”). This of flavor enhancing property etc. is mentioned in the office action above. However, it is also relevant that grain present in beer includes barley grain also as claimed in claim 5 and , therefore, it would have been obvious that foaming property of certain barley proteins present in beer will provide foam beer by glycated lysine. This foaming property is relevant for beer product also.
In response to (ii), it is to be noted that the only independent claim 10 claims the above argued property of “glycated lysine reduces sour flavor when it is 4.7 nmol/ml” in beer product. In this instance, it is not an issue whether Hellwig does or does not suggest that the lysine glycated product has the property of “ reducing sour flavor or enhancing rich flavor” . It is sufficient that NPL Hellwig et al. discloses that lysine glycated product is formed in such product (at least on page 7237 col 2 last paragraph and page 7239 col 1, under Protein bound MRPs in Beer ) . However, when combined teaching is proper, it is to be noted that as because the disclosed glycated lysine are identical to the claimed glycated lysine, therefore, the disclosed glycated lysine containing beer product would have identical property of the beer product with the identical claimed glycated lysine containing beer including the property of “ reducing sour flavor or enhancing rich flavor” as argued by the applicants (in remarks, second page last two paragraphs).
15. Applicants argued in remarks, on third page, last two paragraphs and on last page, first paragraph that
(i) Applicants argued in accordance with MPEP 2143.01 (IV) that “A statement………Obviousness requires “a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does.” KSR Int’] Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007)”
(ii) Ito describes that the average molecular weight of the water-soluble fraction contained in the grain-derived protein degradation product is suitably between 550 and 3000, and that if the molecule size is too large, many fractions will form sediments and become insoluble ([0049] of WO2015/132974). According to Ito, the glycated protein disclosed in Hellwig is expected to be insoluble due to the high molecular weight (>14 kDa). Accordingly, a person of ordinary skill in the art would not be motivated to add the glycated protein disclosed in Hellwig to a non-alcoholic beer-taste beverage.
(iii) Moreover, even if a person of ordinary skill in the art is motivated to do so, it cannot be expected that the glycated protein which forms sediments influences the flavor of the beverage disclosed in Kishimoto or Kino. Withdrawal of the rejection is respectfully requested.
In response to (i), as discussed above, NPL Hellwig et al. has disclosed that “a glycated protein having glycated amino group of lysine” positively influences flavor, color and foaming properties of certain barley proteins (at least in page 7235 col 1 second paragraph lines 7-9, 12-14 and Table 6). This reasoning would have prompted a person of ordinary skill in the relevant field to combine the teaching of modifying Kino et al. with the teaching of NPL Hellwig et al. to make “a glycated protein having glycated amino group of lysine” in order to serve as desired flavor enhancing property , color etc. in different type of beer” in the way the claimed new invention does.” KSR Int’] Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007)”
In response to (ii) and (iii), firstly, it is to be noted that Ito et al. is used as secondary prior art . Ito et al. is not used to address the required size of the peptide necessary to meet claimed invention. NPL Hellwig et al. is used in this respect. Regarding the allegation made by the applicants above that “if the molecular size is too large, many fractions will form sediments and become insoluble ([0049] of WO2015/132974)”, it is to be noted that (i) claimed invention claims 35-50 kDa size and combined teaching meets the claim limitation of the independent claim 1 and (ii) (iii) Even if we consider that the alleged size >14 kDa is insoluble as mentioned in the alleged prior art by WO2015/132974, however, claimed invention does not claim any further solubility and/or related limit of solubility and/or transparency and/or sedimentation issue(s) etc. to be claimed in the final product in claim 1 of the presently claimed invention. Therefore, examiner does not find any reason to respond these arguments further.
However, note that while Ito et al. does not disclose all the features of the present claimed invention, Ito et al. is used as teaching reference, and therefore, it is not necessary for this secondary reference to contain all the features of the presently claimed invention, In re Nievelt, 482 F.2d 965, 179 USPQ 224, 226 (CCPA 1973), In re Keller 624 F.2d 413, 208 USPQ 871, 881 (CCPA 1981). Rather this reference teaches a certain concept, namely grain derived protein in beer includes barley in Beer which serves as “the flavor improving agent” and an additional bubble retention effect (i.e. looks like natural beer) in the final product as taught by Ito et al. (at least on page 5, paragraph 6). Ito et al. in combination with the primary reference discloses the presently claimed invention. Therefore, the combined teaching is proper.
It is also to be noted that and as mentioned above that the alleged “ Kishimoto or Kino” should be Kino et al. reference only.
Conclusion
16. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
Any inquiry concerning the communication or earlier communications from the examiner should be directed to Bhaskar Mukhopadhyay whose telephone number is (571)-270-1139.
If attempts to reach the examiner by telephone are unsuccessful, 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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/BHASKAR MUKHOPADHYAY/
Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792