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 .
Examiner Note
Any objections and/or rejections that are made in the previous actions and are not repeated below, are hereby withdrawn.
In view of the appeal brief filed on 03/11/2026, PROSECUTION IS HEREBY REOPENED. New Ground of rejection are set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791
Claim status
Claims 21, 23-29, 31-32 and 35 are pending in the application and are previously presented. Claims 22, 30, 33, 34, 36, 37 and 38 remain cancelled. Claims 21, 23-29, 31-32 and 35 are hereby examined on the merits.
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 21, 23-29, 31-32 and 35 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 21 recites in the preamble “a flavor ferment with an umami brothy flavor of similar to processed American cheese”. One of the ordinary skill in the art is not apprised the scope of the limitation because it is unclear what kind of umami brothy flavor an American cheese must have such that a flavor ferment is similar to the umami flavor of a processed American cheese. To this end, it does not appear there is consensus on what kind of umami brothy flavor a processed American cheese must have. It is further unclear what standard is applied to measure whether a flavor ferment is “similar to” the umami flavor of a processed American cheese. Clarification is required.
For the same reason above, “an umami brothy flavor of processed American cheese” as recited in the last clause of claim 21 is rejected too. Clarification is required.
Claim 21 recites the ratio of glutamic acid to the total amino acids is 10-15%. It is unclear whether the percent is weight percent or molar percent. For the purpose of examination, it is interpreted that the percent is molar percent. Clarification is required.
Claim 21 recites “with an ingredient statement identical to natural cheese” in the last clause. However, it is unclear what a natural cheese encompasses. Does it limit the way the cheese is produced? Does it limit the ingredients a cheese needs to include or exclude? Note that there are numerous natural cheeses in the world the ingredients of which vary. It is further unclear what the “ingredient statement” means. Does it mean what ingredients are in the flavor ferment? Claim 31 is rejected for the same reason. Clarification is required.
Claims 23-29 depend from claim 21, and claim 32 depends from claim 31, thus necessarily incorporate the indefinite subject matter therein. Appropriate correction is required.
Claim 35 recites “producing an umami flavor ferment from the same ingredients as the natural cheese” in the preamble. It is unclear what a natural cheese must have such that the flavor ferment is produced from the same ingredient of a natural cheese. Does it limit the way the cheese is produced? Does it limit the ingredients a cheese need to include or exclude? Note that there are numerous natural cheeses in the world and their ingredients vary. Clarification is required.
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.
Claims 21, 24, 28, 29, 31, 32 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Crow US Patent Application Publication No. 2005/0123646 A1 (hereinafter referred to as Crow) in view of Brown CA 2280551 A1 (hereinafter referred to as Brown), Bagnasco, “Use of food-grade protease to recover umami protein-peptide mixtures from rice middlings”, Food Research International 2013, 50, pages 420-427 (hereinafter referred to as Bagnasco), Dias US Patent Application Publication No. 2005/0112238 A1(hereinafter referred to as Dias) and OH US Patent Application Publication No. 2016/0113315 A1 (hereinafter referred to as OH).
Regarding claim 21, Crow teaches a method for producing a flavor ferment (e.g., cheese flavor ingredient; 0007) for enhancing the flavor of cheese (0073), the method comprising the steps of: providing a milk substrate (0008; 0013-0014, a mixture of dairy protein and water, where the dairy protein is one or more of whole milk powder, milk protein concentrate, a casein, etc.); pasteurizing the milk substrate (0058; the reaction mixture is heated at a temperature of 93 °C for 15 min to inactivate microbes); adding an enzyme (e.g., protease) to the pasteurized milk substrate and then incubating to produce an enzyme mixture (0009; 0061; 0020); inactivating the enzyme in the enzyme mixture (0021) and necessarily a cooling step follows since the enzyme mixture will be removed from the heating source for pasteurization; inoculating the enzyme mixture with a starter culture to produce a pre-fermentation mixture (0010); fermenting the pre-fermentation mixture at temperature of 25-50 °C to produce a fermented mixture (0011); and pasteurizing the fermented mixture to produce the flavor ferment (0068, terminating the fermentation by heating at a temperature of 93 °C for 15 min; according to 0058, such a heating condition is able to inactive microbes as well, thus reading on the limitation about the pasteurization).
Crow teaches that the starter culture includes Enterococcus faecium, Enterococcus faecalis, Enterococcus casseliflavus, etc., (0010), thus being silent regarding Lactobacillus helveticus. Crow is further silent regarding the flavor ferment having an umami brothy flavor.
In the same field of endeavor, Brown teaches a method of producing a flavored component for use in cheese manufacture, the method comprising adding an enzyme system to a milk substrate which is an aqueous dairy protein source (page 5, line 12-25), wherein the dairy protein source includes milk protein concentrate, whey protein concentrate and non-fat dry milk (page 6, line 10-14), wherein the enzyme system includes 0.2-0.4% protease in powdered form (e.g. , Flavourzyme) by weight of the milk substrate (page 8, first para.) and a peptidase source (e.g., Lactobacillus helveticus) (page 8, 2nd para.). Further, Brown includes an example in which the pasteurized milk substrate is treated with Flavorzyme first, followed by incubating the enzyme-treated milk substrate with Lactobacillus helveticus and an inactivation step (page 11, Example 1).
Bagnasco teaches that treating a substrate containing protein (e.g., rice middlings) with Flavourzyme will result in composition having umami flavor, due to the proteolytic activity of the enzyme on the protein (Abstract; Fig. 4; page 424 right hand column, para. 1-3).
Dias in the same field of endeavor teaches a method of making a cheese flavoring system comprising fermenting a milk substrate with a starter culture comprising Lactobacillus helveticus in the presence of a protease (0069-0070; 0075), additionally, Dias teaches that Lactobacillus helveticus is a LAB with aminopeptidase activity, and the aminopeptidase in concert with the protease creates a high concentration of free amino acids and small peptides that contributes to the cheese flavor (0075).
Crow, Brown and Dias are all directed to treating a milk substrate with a protease and a lactic acid bacteria to produce a flavoring composition; wherein Brown teaches treating a substrate comprising protein with Flavourzyme, Bagnasco teaches that treating a protein-containing substrate with Flavourzyme will result in composition having umami flavor; and wherein Brown teaches treating a milk substrate with Lactobacillus helveticus, Dias teaches that Lactobacillus helveticus is a LAB with aminopeptidase activity, and the aminopeptidase in concert with the protease creates a high concentration of free amino acids and small peptides that contributes to the flavor (0075). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified Crow by replacing the protease of Crow with Flavorzyme protease for making a flavor fermenting with umami flavor, and replacing the starter culture of Crow with Lactobacillus helveticus so as to create a high concentration of free amino acids and small peptides that contributes to the flavor the flavor ferment.
Further, MPEP 2144.06 II states that substituting equivalents known for the same purpose is prima facie obvious thus in the instant case, where prior art has established that Flavourzyme, Protease A, Neutrase and Flavorpro 192P are functional enzyme equivalents in cleaning milk protein for imparting flavor, and Lactobacillus helveticus, Enterococcus faecium, Enterococcus faecalis and Enterococcus casseliflavus are functional bacterial equivalents in fermenting milk substrate for imparting flavor, therefore, it would have been obvious to substitute one for another for the same purpose).
Crow as modified by Brown, Bagnasco and Dias teaches a flavor ferment having an umami flavor, but is silent regarding the ratio of free glutamic acid to the total free amino acids in the flavor ferment.
OH in the field of flavor art teaches that glutamic acid is the main contributor of an umami flavor (0029). On the other hand, the amino acids profile of a product resulting from protease incubation and LAB fermentation of a milk substate is necessarily a parameter of the protein composition in the milk substrate, the enzymatic reaction condition (e.g., dosage, temperature, duration, etc.), or the fermentation condition (e.g., inoculum size, duration of fermentation), given that protease enzyme and the enzyme from LAB work individually or together to cleave the milk protein in the milk substrate. Therefore, one of ordinary skill in the art would have been motivated to manipulate the above conditions to ensure that the amount of free glutamic acid in the flavor ferment is such that a desired umami flavor intensity is obtained for the flavor ferment. As such, the ratio of free glutamic acid to total free amino acids as recited in claim 21 is merely an obvious variant of the prior art.
Crow as modified with Brown, Bagnasco, Dias and OH teaches treating a milk substrate with Flavourzyme which will produce a flavor ferment having umami flavor. Further, cited arts in combination teaches treating a milk substrate with Flavorzyme and Lactobacillus helveticus which is the same as the claimed invention. Therefore, the limitation about the flavor ferment having an umami brothy flavor of processed American cheese is met by the cited arts in combination. Note that the instant specification (0031 and Table 3) recites that treating a milk substrate with such a combination will result in a flavor ferment having an umami savory brothy flavor.
Given that Crow as modified with Brown, Bagnasco, Dias and OH arrives at the claimed method (e.g., inoculating the same milk substrate with an enzyme followed by inactivation and fermenting the enzyme treated milk substrate with the same culture), it logically follows that the method as disclosed by prior art would have resulted in a flavor ferment with an ingredient statement identical to a natural cheese. See In re Best.
Regarding claim 24, Crow as modified with Brown, Bagnasco, Dias and OH as recited above teaches an enzyme dosage of 0.2-0.4%, the upper bound of which is very close to 0.5% as claimed that one skilled in the art would have expected them to have the same properties, given that both claimed invention and prior art are directed to treating a milk substrate with a protease to make a flavor ferment. It has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (MPEP 2144.05).
Of note is that where prior art teaches a dosage of enzyme in powdered form, the claimed invention does not shed light on whether the enzyme dose is based on solid or liquid.
Further, the dosage of an enzyme in an enzymatic reaction is among the general conditions known by one of ordinary skill in the art to affect the amount product (e.g., free amino acids) generated as the flavor component (see Brown page 9 para. 2). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have optimized the dose of the enzyme through routine experimentation to so as to ensure that sufficient amount of umami flavor component is produced. Generally, differences in concentration or temperature will not support the patentability of the subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 “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”. (See MPEP 2144.05 II).
Regarding claim 28, Crow teaches a fermentation pH of 5-8 for using Enterococcus faecium, Enterococcus faecalis, Enterococcus casseliflavus, etc. (0010-0011); further, Brown teaches that the pH of fermentation using Lactobacillus helveticus occurs at a level of 4-6 (page 6, 2nd para. from the bottom; page 8, 2nd para.). therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have controlled the pH at a range of 4-6 for desired fermentation.
Regarding claim 29, Crow teaches a fermentation time of 20-100 hours till the desired ingredient has been produced, using Enterococcus faecium, Enterococcus faecalis, Enterococcus casseliflavus, etc. (0066; 0010); further, Brown teaches that the milk substrate is treated with the enzyme system (e.g., Flavorzyme, lipase and Lactobacillus helveticus, page 7 bottom para. and page 8 para. 1-2) for a period of from 12-240 hours to reach desired flavor level, as judged organoleptically or by measuring the concentrations of free fatty acids and amino acids (page 9, 2nd para.); in particular, a first enzyme treatment is conducted for 2-6 hours, and a second enzyme treatment is conducted for 6-240 hours (page 10, 2nd para. from the bottom) (in example 1, Flavorzyme treatment is conducted for 4 hours and Lactobacillus helveticus + esterase is done for 48 hours). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have manipulated the fermentation time till the desired flavor is reached. As such, the limitation about the fermentation time are merely obvious variants of the prior art.
Regarding claim 31, Crow as modified with Brown, Bagnasco, Dias and OH teaches a method of producing a flavor ferment in connection with claim 21, which is incorporated by reference. Note that Flavorzyme is the aminopeptidase has a CAS no. 9001-61-0.
Further, the reasoning as relied upon in rejecting the claim 21 limitation about the ratio of free glutamic acid to the total free amino acids is applicable to the limitation about the concentration of the free glutamic acid in the flavor ferment as recited in claim 31. Further, the concentration of free glutamic acid is also a parameter of the dry matter amount especially the protein dry matter amount in the milk substate, therefore, one of ordinary skill in the art would have been motivated to manipulate the protein dry matter content in the milk substrate besides manipulating the enzymatic conditions and fermentations condition so as to ensure the final flavor ferment has a desired intensity of umami flavor. As such, the free glutamic acid content as recited in claim 31 is merely an obvious variant of the prior art.
Regarding claim 32, Crow teaches a milk substrate which is a mixture of dairy protein and water, where the dairy protein is one or more of whole milk powder, milk protein concentrate, casein, etc. (0008; 0013-0014). Crow is silent regarding adding non-fat dry milk to the milk substrate form a mixture.
Brown teaches that the dairy protein source includes milk protein concentrate, whey protein concentrate and non-fat dry milk (page 6, line 10-14).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified Crow by including non-fat dry milk in the milk substate of Crow with reasonable expectation of success, for the reason that prior art has established that non-fat dry milk is an art-recognized dairy protein source suitable for making a flavor ferment. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See MPEP 2144.07. Additionally, one of ordinary skill in the art would have been motivated to combine whole milk powder, milk protein concentrate or casein with non-fat dry milk because "it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Regarding claim 35, Crow as modified with Brown, Bagnasco, Dias and OH teaches a method of producing a flavor ferment in connection with claim 21, which is incorporated by reference.
Further, the reasoning as relied upon in rejecting the claim 21 limitation about the ratio of free glutamic acid to the total free amino acids is applicable to the limitation that the free glutamic acid in mass being greater than any other free amino acids in the flavor ferment as recited in claim 35. In particular, knowing that glutamic acid is the main contributor of an umami flavor, and that the amino acid profile of a product resulting from protease incubation and LAB fermentation of a milk substate is necessarily a parameter of the protein composition of the milk substrate, the enzymatic reaction condition (e.g., dosage, temperature, duration, etc.), or the fermentation condition (e.g., inoculum size, duration of fermentation), one of ordinary skill in the art would have been motivated to manipulate the above conditions to ensure the main umami component glutamic acid is dominant among all the free amino acid. As such, the limitation that the free glutamic acid is in a mass that is greater than other free amino acid is merely an obvious variant of the prior art.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Crow as modified with Brown, Bagnasco, Dias and OH as applied to claim 21 above, and further in view of Eisele US Patent Application Publication No. 2018/0042253 A1 (hereinafter referred to as Eisele).
Regarding claim 23, Crow teaches a pasteurization time of 15 min at 93 °C for the milk substrate (0058), and Brown teaches a pasteurization time of 5 min at 73°C (e.g., 165 °F) (page 11, example 1). Cited arts are silent regarding the 30 min pasteurization time.
Eisele teaches that a milk substrate can be pasteurized for at least 15 min (0132-0133).
Both Crow and Eisele are directed to pasteurizing a milk substrate. It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified Crow by pasteurizing the milk substrate for at least for 15 min with reasonable expectation of success, for the reason that prior art has establish that it is suitable to pasteurize a milk substrate for at least 15 min to effectively inactive microbes.
The duration of pasteurization as disclosed by Eisele encompasses the time as recited in the claim. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. (MPEP 2144.05 I).
Claims 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Crow in view of Brown as applied to claim 21 above, and further in view of Jaeggi US Patent No. 4,001,437 (hereinafter referred to as Jaeggi).
Regarding claims 25-26, Crow recites a duration of proteolysis reaction for 2-24 hours (0020); further, Brown teaches that the milk substrate is treated with the enzyme system (e.g., Flavorzyme as the protease, lipase and Lactobacillus helveticus, page 7 bottom para. and page 8 para. 1-2) for a period of from 12-240 hours to reach desired flavor level, as judged organoleptically or through measuring the concentrations of free fatty acids and amino acids (page 9, 2nd para.); in particular, a first enzyme treatment is conducted for 2-6 hours, and a second enzyme treatment is conducted for 6-240 hours (page 10, 2nd para. from the bottom) (in example 1, Flavorzyme treatment is conducted for 4 hours and Lactobacillus helveticus + esterase is done for 48 hours).
Further, Jaeggi in the same field of endeavor teaches a process for making a flavorant from milk product (e.g., skim milk) comprising first treating the milk product with a protease followed by lactic acid fermentation (column 1, line 18-22; Table in column 1; column 2, line 4-11), in which the proteolysis is conducted for 1-20 hours for the protease to degrade protein into peptides and (free) amino acids (column 2, line 35-37; 10-11).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have manipulated the enzyme incubation time for desired amount of free amino acid as a flavor components. As such, the incubation time as recited in claim 25 or 26 is merely an obvious variant of the prior art.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Crow as modified with Brown, Bagnasco, Dias and OH as applied to claim 21 above, and further in view of Park, “Production of benzoic acid as a natural compound in fermented skim milk using commercial cheese starter”, J. Dairy Sci. 2017, 100(6), pp. 4269-4275 (hereinafter referred to as Park) and Moser, “Detection and enumeration of Lactobacillus helveticus in dairy products”, International Dairy Journal, 2017, 68, pp. 52-59 (hereinafter referred to as Moser).
Regarding claim 27, Crow as modified with Brown, Bagnasco, Dias and OH teaches Lactobacillus helveticus but is silent regarding the LH13 or LH32 strain, however, where prior art establishes the suitability of Lactobacillus helveticus for use to make a flavor ferment, one of ordinary skill in the art would have been motivated to use any Lactobacillus helveticus strain available such as LH13 and LH32 to use and reasonable expect that the strain is able to ferment milk and to produce a flavor ferment.
Further, Park teaches that Lactobacillus helveticus LH13 is a commercial starter suitable for making cheese (Table 1), and Moser teaches that Lactobacillus helveticus LH32 is a commercial starter suitable for making fermented dairy product (Table 1) Crow, Brown, Park and Moser are all directed to starter cultures. It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have used Lactobacillus helveticus LH13 or LH32 as the Lactobacillus helveticus source with reasonable expectation of success, for the reason that such a strain is commercially available and can be used to ferment milk.
Cited arts are silent regarding the inoculum size for the Lactobacillus helveticus.
Dias in the same field of endeavor teaches a method of making a cheese flavoring system comprising fermenting a milk substrate with a starter culture comprising Lactobacillus helveticus at an inoculum size of 0.01-3% (0017; 0069; 0075).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have used an inoculum size of 0.01-3% with reasonable expectation of success, for the reason that prior art has established that such an inoculum size for Lactobacillus helveticus in the process of producing a flavor ferment is suitable. The inoculum size as disclosed by Dias encompasses the amount as recited in the claim. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. (MPEP 2144.05 I).
Claims 21, 24, 25, 26, 31 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Washizu US Patent No. 8,993,016 B2 (cited in the IDS filed 09/06/2022, hereinafter referred to as Washizu) in view of Bagnasco, “Use of food-grade protease to recover umami protein-peptide mixtures from rice middlings”, Food Research International 2013, 50, pages 420-427 (hereinafter referred to as Bagnasco), and OH US Patent Application Publication No. 2016/0113315 A1 (hereinafter referred to as OH).
Regarding claim 21, Washizu teaches a method for producing a flavor ferment (e.g., a flavor enhancer) comprising the steps: providing a milk substrate (e.g., a total milk protein which is also called milk protein concentrate, column 3, line 51-58); pasteurizing the milk substrate to produce a pasteurized milk substrate (column 7, line 63-65); adding a protease enzyme to the pasteurized milk substrate and then incubating to produce an enzyme mixture, wherein the protease enzyme is one or more of Protease N, Flavourzyme, Protease A, Debitrase, Denapsin 2P, Kokulase P, etc. (column 3, line 41-48; column 5, line 10-32); inactivating the protease by heating at a temperature of 70-90 °C (column 5, line 49-51); inoculating the enzyme treated mixture with a lactic acid bacteria such as Lactobacillus helveticus and fermenting the mixture at a temperature of 25-45 °C to produce a fermented mixture (column 3, line 41-48; column 4, line 25-44; column 5, line 2), and pasteurizing the fermented milk which necessarily produces the flavor ferment (column 8, line 65-column 9, line 1-2). Necessarily a cooled enzyme mixture is formed after heat inactivation but before inoculation, since the moment the enzyme mixture is removed the heat source, the cooling starts, and that the heating inactivation is conducted at a higher temperature than fermentation temperature.
Washizu teaches a flavor ferment made by treating a milk substrate with a protease enzyme such as Protease N, Flavourzyme, Protease A, Debitrase, Denapsin 2P, Kokulase P, etc., but is silent regarding the flavor ferment has an umami brothy flavor.
Bagnasco teaches that treating a substrate containing protein (e.g., rice middlings) with Flavourzyme will result in composition having umami flavor, due to the proteolytic activity of the enzyme (Abstract; Fig. 4; page 424 right hand column, para. 1-3).
Both Washizu and Bagnasco are directed to treating a protein-containing substrate with Flavourzyme. It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified by selecting Flavourzyme among other proteases as the protease to treat the milk substrate so as to obtain a flavor ferment having an umami flavor. One of ordinary skill in the art, before the effective filing date of the claimed invention, would have had a reasonable expectation of success for doing so because prior art has established that treating a protein with Flavourzyme will result in an umami flavor.
Washizu as modified by Bagnasco teaches a flavor ferment having an umami flavor, but is silent regarding the ratio of free glutamic acid to the total free amino acids in the flavor ferment.
OH in the field of flavor art teaches that glutamic acid is the main contributor of an umami flavor (0029). On the other hand, the amino acids profile of a product resulting from protease incubation and LAB fermentation of a milk substate is necessarily a parameter of the protein composition in the milk substrate, the enzymatic reaction condition (e.g., dosage, temperature, duration, etc.), or the fermentation condition (e.g., inoculum size, duration of fermentation), given that protease enzyme and the enzyme from LAB work individually or together to cleave the milk protein in the milk substrate. Therefore, one of ordinary skill in the art would have been motivated to manipulate the above conditions to ensure that the amount of free glutamic acid in the flavor ferment is such that a desired umami flavor intensity is obtained for the flavor ferment. As such, the ratio of free glutamic acid to total free amino acids as recited in claim 21 is merely an obvious variant of the prior art.
Washizu as modified by Bagnasco and OH teaches treating a milk substrate with Flavourzyme which will produce a flavor ferment having umami flavor. Further, cited arts in combination teach treating a milk substrate with Flavourzyme and Lactobacillus helveticus which is the same as the claimed invention. Therefore, the limitation about the flavor ferment having an umami brothy flavor of processed (American) cheese is met by the cited arts in combination. Note that the instant specification (0031 and Table 3) recites that treating a milk substrate with such a combination will result in a flavor ferment having an umami savory brothy flavor.
Given that Washizu as modified by Bagnasco and OH arrives at the claimed method (e.g., inoculating the same milk substrate with an enzyme followed by inactivation and fermenting the enzyme treated milk substrate with the same culture), it logically follows that the method as disclosed by prior art would have resulted in a flavor ferment with an ingredient statement identical to a natural cheese. See In re Best.
Regarding claim 24, Washizu teaches that it is desirable that the amount of the protease to be used in carrying out the protease treatment is set to a range from 10 to 3000 units per 1 gram of a milk protein (column 5, line 33-35), given that where prior art teaches a more accurate of enzyme dose but the claimed invention does not shed light on whether the enzyme dose is based on solid or liquid, claim 24 is considered obvious over the teaching of the prior art.
Further, the dosage of an enzyme in an enzymatic reaction is among the general conditions known by one of ordinary skill in the art to affect the amount product (e.g., free amino acids) generated as the flavor component. It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have optimized the dose of the enzyme through routine experimentation to so as to ensure that the sufficient amount umami flavor component is produced. Generally, differences in concentration or temperature will not support the patentability of the subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 “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”. (See MPEP 2144.05 II).
Regarding claims 25-26, Washizu teaches an enzymatic treatment time of 1-96 hours (column 5, line 45-48). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. (MPEP 2144.05 I).
Regarding claim 31, Washizu as modified by Bagnasco and OH teaches a method of producing a flavor ferment in connection with claim 21, which is incorporated by reference. Note that Flavorzyme is the aminopeptidase has a CAS no. 9001-61-0.
Further, the reasoning as relied upon in rejecting the claim 21 limitation about the ratio of free glutamic acid to the total free amino acids is applicable to the limitation about the concentration of the free glutamic acid in the flavor ferment as recited in claim 31. Further, the concentration of free glutamic acid is also a parameter of the dry matter amount especially the protein dry matter amount in the milk substate, therefore, one of ordinary skill in the art would have been motivated to manipulate the protein dry matter content in the milk substrate besides manipulating the enzymatic conditions and fermentations condition so as to ensure the final flavor ferment has a desired intensity of umami flavor. As such, the free glutamic acid content as recited in claim 31 is merely an obvious variant of the prior art.
Regarding claim 35, Washizu as modified by Bagnasco and OH teaches a method of producing a flavor ferment in connection with claim 21, which is incorporated by reference.
Further, the reasoning as relied upon in rejecting the claim 21 limitation about the ratio of free glutamic acid to the total free amino acids is applicable to the limitation that the free glutamic acid in mass being greater than any other free amino acids in the flavor ferment as recited in claim 35. In particular, knowing that glutamic acid is the main contributor of an umami flavor, and that the amino acids profile of a product resulting from protease incubation and LAB fermentation of a milk substate is necessarily a parameter of the protein composition of the milk substrate, the enzymatic reaction condition (e.g., dosage, temperature, duration, etc.), or the fermentation condition (e.g., inoculum size, duration of fermentation), one of ordinary skill in the art would have been motivated to manipulate the above conditions to ensure the main umami component glutamic acid is dominant among all the free amino acid). As such, the limitation that the free glutamic acid is in a mass that is greater than other free amino acid is merely an obvious variant of the prior art.
Response to Arguments
Appellant's arguments filed 03/11/2026 have been fully considered and the examiner’s response is presented below:
The 35 USC 112 (a) rejection is withdrawn, since appellant’s argument on page 5 of the Brief that the parent application 17/385,140 supports the ratio of the glutamic acid to the total amino acids as recited is persuasive.
Appellant argues on pages 6-7 of the Brief that Crow does not teach a cheese flavor ingredient that has the Standard of Identity of a natural cheese due to the addition of an emulsifying salt.
The arguments are considered but found unpersuasive because it is unclear what the Standard of Identity of a natural cheese is referring to. Attention is drawn to the 35 USC 112 (b) rejection of the limitation that an ingredient statement is identical to natural cheese in the instant office action.
On the other hand, it appears that in Crow, the emulsifying salt is used when the substrate is cheese and is for forming an emulsion (see para. 0013 and 0054 of Crown). Crow also includes the embodiment that the substrate is not a cheese or an emulsion. Rather, it could be milk or milk components in which case the emulsifying salt is not needed.
For the reason set forth above, appellant’s argument on pages 9 and 12 of the Brief that Crow is silent regarding Ingredient statement because Crow uses an emulsifying salt is not persuasive.
Appellant argues on page 7 of the Brief that Crow teaches a general cheese flavor profile as opposed to a specific umami flavor.
The argument is piecemeal, since the rejection is over Crow as modified by Brown, Bagnasco, Diaz and Oh. To this end, since the arts in combination disclose treating a milk substrate with Flavourzyme and Lactobacillus helveticus which is the same as the invention as claimed, it thus logically follows that the umami flavor is obtained by prior art.
Appellant argues on pages 7-8 of the Brief that Crow does not teach Lactobacillus helveticus and there is no motivation to modify Crow to use Lactobacillus helveticus and there is no reasonable expectation of success. Appellant further argues that the Office does not provide a reason to use Lactobacillus helveticus.
The argument is considered but found unpersuasive. The motivation to substitute Lactobacillus helveticus for the bacteria of Crow is provided in the para. 21 of the office action issued 08/28/2025 which states that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified Crow by replacing the protease of Crow with Flavorzyme protease for making a flavor fermenting with umami flavor, and replacing the starter culture of Crow with Lactobacillus helveticus so as to create a high concentration of free amino acids and small peptides that contributes to the flavor the flavor ferment. On the other hand, since it is known to use Lactobacillus helveticus to ferment a milk substrate to product flavor ferment, there is a reasonable expectation of success.
Further, MPEP 2144.06 II states that substituting equivalents known for the same purpose is prima facie obvious thus in the instant case, where prior art has established that Flavourzyme, Protease A, Neutrase and Flavorpro 192P are functional enzyme equivalents in cleaving milk protein for imparting flavor, and Lactobacillus helveticus, Enterococcus faecium, Enterococcus faecalis and Enterococcus casseliflavus are functional bacterial equivalents in fermenting milk substrate for imparting flavor, therefore, it would have been obvious to substitute one for another for the same purpose).
Appellant argues on page 8 of the Brief that Crow does not mention an umami flavor.
The argument is piecemeal. Where cited arts in combination arrive at the steps of treating a milk substrate with Flavourzyme and Lactobacillus helveticus, the umami flavor is taught by the arts.
Appellant argues on pages 8 and the para. that bridges pages 11 and 12 of the Brief that one of ordinary skill in the art would not look to the teaching of Bagnasco which treats a non-dairy protein source with Flavourzyme.
Appellant’s arguments are considered but found unpersuasive. Bagnasco is cited to teach that treating a protein substrate with Flavourzyme will result in a composition having umami flavor, due to the proteolytic activity of the enzyme on the protein. Bagnasco is not cited to teach treating milk with Flavourzyme. To this end, it is found out that the feature of treating a milk substrate with Flavourzyme for flavoring purpose is known in the prior art, for example, both Brown and Washizu as cited in the rejection teach cleaving milk protein with Flavourzyme for generating flavor (see Brown page 8, first para and Washizu column 3, line 41-48; column 5, line 10-32). Therefore, given that it is known that Flavourzyme could cleave a milk substrate for creating a flavor ferment, and that Flavourzyme would cleave a protein to produce umami flavor, one of ordinary skill in the art would have chosen Flavourzyme to cleave a milk protein for the purpose of developing flavor ferment having umami flavor.
Appellant argues on pages 8 and 11 of the Brief that the Office action has used impermissible hindsight to reject the claims.
The argument is considered but found unpersuasive. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the instant case, the examiner submits that appellant has not shed light on which limitation in the claims is solely from appellant’s own disclosure.
Appellant argues on pages 8-9 of the Brief that Crow fails to teach an umami flavor of processed American cheese. Appellant further argues that the Office’s conclusion that that the umami flavor of prior art is the same as processed American cheese is not supportable.
The argument is considered but found unpersuasive. The limitation about an umami flavor of processed American cheese is now rejected for being indefinite. See para. 6 of the instant office action.
On the other hand, given that cited arts in combination teach treating a milk substrate with Flavourzyme and Lactobacillus helveticus which is the same as the claimed invention, the limitation about the flavor ferment having an umami brothy flavor of processed American cheese is met by the prior art. Note that the instant specification (0031 and Table 3) recites that treating a milk substrate with such a combination of the enzyme and the bacteria will result in a flavor ferment having an umami savory brothy flavor.
Regarding the limitation about the ratio of free glutamic acid to total free amino acids being in the range of 10-15%, or the limitation that the free glutamic acid is 10000-30000 µM, appellant argues on pages 9-10 and 13 of the Brief that the ratio or the amount of glutamic acid is not an obvious variant of the prior art, rather, it is a specific result of the specific ingredients used in the flavor ferment to produce a specific flavor profile. Appellant further argues that the Office gives no basis for concluding that changing the bacteria, flavor, dry matter content of the substrate, enzymatic reaction conditions, and fermentation conditions will arrive at the ratio as claimed.
The examiner disagrees. It is noted that Crow as modified by Brown, Bagnasco, Dias and OH teaches the same ingredients (e.g., the substrate, enzyme and bacteria) as the claimed invention. Further, where prior art establishes that glutamic acid is the main contributor of an umami flavor and that it is known that the amino acids profile of a product resulting from protease incubation and bacteria fermentation of a milk substate is necessarily a parameter of the protein composition in the milk substrate, the enzymatic reaction condition (e.g., dosage, temperature, duration, etc.), or the fermentation condition (e.g., inoculum size, duration of fermentation), therefore, one of ordinary skill in the art would have been motivated to manipulate the above conditions to ensure that the amount of free glutamic acid in the flavor ferment is such that a desired umami flavor intensity is obtained.
Further, it is noted that appellant has not shown by convincing evidence any criticality associates with the ratio or the amount of glutamic acid.
Appellant argues on page 11 of the Brief that according to the Declaration filed 02/06/2025, there is no motivation or reasonable expectation of success to modify Crow to replace the enzyme and the lactic acid ferment of Crow with Flavourzyme and Lactobacillus helveticus.
The examiner disagrees. The Declaration filed 02/06/2025 has been addressed in the office action issued 04/02/2025 (see para. 81-86).
Appellant argues on page 11 of the Brief that Crow reference teaches Enterococcus, Staphylococcus or Pseudomonas as the proper bacteria and a blend of proteinase and peptidase as the enzyme for use, and there is no suggestion to use a different bacteria or enzyme. The examiner cites Brown, Bagnasco and Diaz to teach L. helveticus or an aminopeptidase but the Office does not give reason why a skilled person will modify Crow to use another bacteria such as L. helveticus among the multitude of bacteria available to those skilled in the art.
The argument is considered but found unpersuasive. Contrary to appellant’s opinion, the Office actually provides a reason to modify Crow to use L. helveticus or an aminopeptidase. See para. 21 of the final rejection issued 08/28/2025 which states that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified Crow by replacing the protease of Crow with Flavorzyme protease for making a flavor fermenting with umami flavor, and replacing the starter culture of Crow with Lactobacillus helveticus so as to create a high concentration of free amino acids and small peptides that contributes to the flavor the flavor ferment.
Further, MPEP 2144.06 II states that substituting equivalents known for the same purpose is prima facie obvious thus in the instant case, where prior art has established that Flavourzyme, Protease A, Neutrase and Flavorpro 192P are functional enzyme equivalents in cleaning milk protein for imparting flavor, and Lactobacillus helveticus, Enterococcus faecium, Enterococcus faecalis and Enterococcus casseliflavus are functional bacterial equivalents in fermenting milk substrate for imparting flavor, therefore, it would have been obvious to substitute one for another for the same purpose).
Further, the examiner submits that there is no requirement that the primary reference Crow needs to have a suggestion to use a different enzyme or bacteria. The motivation can be in a secondary reference (e.g., Brown, Bagnasco, Dias in the instant case).
Further, although there might be a multitude of bacteria available to those skilled in the art, the rejection relied upon L. helveticus as specifically taught by the secondary references Brown and Diaz.
Regarding the 35 USC 103 rejection over Washizu in view of Bagnasco and Oh, appellant argues on pages 16-19 of the Brief that where Washizu relates to a flavor enhancer of a fresh milk and a rich feel, there is no suggestion or motivation to modify Washizu to create an umami flavor.
The examiner disagrees. The argument overlooks the facts that the umami flavor as claimed are the result of treating milk with Flavourzyme and fermenting with Lactobacillus helveticus. It just happens that Flavourzyme and Lactobacillus helveticus are among the enzymes and bacteria used by Washizu. As such, the production of umami flavor is encompassed by prior art.
Further, it does not appear that the raw milk flavor as taught by Washizu excludes an umami flavor.
Regarding the limitation about the ratio of free glutamic acid to total amino acids or the amount of glutamic acid, appellant argues on page 17-19 of the Brief that the ratio or the amount of glutamic acid is not an obvious variant of the prior art, rather, it is a specific result of the specific ingredients used in the flavor ferment to produce a specific flavor profile. Appellant further argues that the Office gives no basis for concluding that changing the bacteria, flavor, dry matter content of the substrate, enzymatic reaction condition, fermentation condition will arrive at the ratio as claimed.
The examiner disagrees. It is noted that Washizu as modified by Bagnasco and OH teaches the same ingredients (e.g., the milk substrate, enzyme and bacteria) as the invention as claimed. Further, where prior art establishes that glutamic acid is the main contributor of an umami flavor and that it is known that the amino acids profile of a product resulting from protease incubation and bacteria fermentation of a milk substate is necessarily a parameter of the protein composition in the milk substrate, the enzymatic reaction condition (e.g., dosage, temperature, duration, etc.), or the fermentation condition (e.g., inoculum size, duration of fermentation), therefor, one of ordinary skill in the art would have been motivated to manipulate the above conditions to ensure that the amount of free glutamic acid in the flavor ferment is such that a desired umami flavor intensity is obtained for the flavor ferment.
Further, it is noted that appellant has not shown by convincing evidence any criticality associates with the ratio or the amount of glutamic acid.
Conclusion
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/CHANGQING LI/Primary Examiner, Art Unit 1791
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