DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
Receipt of the Request for Continued Examination (RCE under 37 CFR 1.114), the Response, and Amendment filed 01/08/2026 is acknowledged.
Applicant has overcome the following rejections by cancellation of the claims: (1) the 35 U.S.C. §103 rejections of claims 17, 26, and 34 over Schlothauer and Payne have been withdrawn; and (2) the 35 U.S.C. §103 rejections of claims 8-14 and 18-23 over Schlothauer, Payne, and Folkenberg have been withdrawn.
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1-7, 15, 27-31, 35-52, 86-88
Withdrawn claims: None
Previously cancelled claims: 16, 24-25, 32-33, 53-85
Newly cancelled claims: 8-14, 17-23, 26, 34
Amended claims: 1, 15
New claims: 86-88
Claims currently under consideration: 1-7, 15, 27-31, 35-52, 86-88
Currently rejected claims: 1-7, 15, 27-31, 35-52, 86-88
Allowed claims: None
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/08/2026 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 43, 44, 45, 46, 47, and 48 are rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 43, 44, 45, 46, 47, and 48 recite concentrations of protein in the milk that are outside of the 3.5-4.0 wt.% recited in present claim 1. These claims recite minimum concentrations of protein (e.g., at least about 3.7 wt.% in claim 45), but do not recite maximum concentrations of protein so that the maximum concentrations of protein permitted by these claims include concentrations greater than the 4.0 w.% recited in claim 1. The concentrations of protein recited in claims 43 and 44 also include amounts below the minimum 3.5 wt.% protein recited in claim 1 since the term “about” implies a ±5% deviation from the recited percentage per line 30 in page 10 of the present specification.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-7, 15, 27-31, 35-52, and 86-88 are rejected under 35 U.S.C. 112(b) 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.
Claims 1 and 86 recite the limitations “said sweetened milk” or "the sweetened milk". There is insufficient antecedent basis for these limitations in the claims.
For the purpose of this examination, “said sweetened milk” and “the sweetened milk” will be interpreted as being the milk comprising 2-8 wt.% sucrose.
Regarding claim 88, the parentheses render the claim indefinite because it is unclear whether the limitations within the parentheses are part of the claimed invention. See MPEP § 2173.05(d).
For the purpose of this examination, the claim will be interpreted meaning filling at 24°C.
Claims 2-7, 15, 27-31, 35-52, and 87 are rejected by reason of dependency from claim 1.
Claim Rejections - 35 USC § 103
Claims 1-7, 15, 27-31, 35-39, and 86 are rejected under 35 U.S.C. 103 as being unpatentable over Schlothauer (US 2006/0057704; IDS citation) in view of Folkenberg (US 2014/0348980; IDS citation) and Payne (US 2015/0004650; previously cited) as evidenced by Ladder (“Whey Protein Isolate vs. Concentrate: Which is Better?, 2023, Ladder, https://ladder.sport/pages/whey-protein-isolate-vs-concentrate/; previously cited).
Regarding claims 1 and 15, Schlothauer teaches a method of making a yogurt product having increased thickness (corresponding to viscosity) and increased mouthfeel [0157]. Schlothauer teaches that the method comprises the steps of: providing dairy milk from an animal [0099]; adding sucrose to the milk to form sweetened milk (corresponding to sucrose fortified milk) [0157]; contacting the sweetened milk with an isolated glucosyltransferase (corresponding to the components of the composition including the enzyme being prepared in isolation ([0103]; [0157]; page 17, claim 35)); and fermenting the sweetened milk to provide the yogurt product having an improved texture comprising increased thickness and increased mouthfeel compared to a product not comprising the enzyme [0076], [0157]. Glycosyltransferase uses sugar molecules to produce exo-polysaccharides (EPS) [0022]-[0024] which causes the increase in viscosity and the increase in mouthfeel in a yogurt product compared to a product not comprising the enzyme [0019], [0157]. Since the yogurt is produced by fermenting the sweetened milk containing the glucosyltransferase [0157], then the method of Schlothauer comprises a step of inoculating the milk with a starter culture prior to fermentation.
Schlothauer also teaches that the amount of glucosyltransferase present in the milk will depend on the product to be treated, the method of contacting the product with the composition, the intended use of the product [0136]; and exemplifies an amount of glucosyltransferase of about 0.1% to about 10% in the yogurt milk [0157]. As the amount of glucosyltransferase in the milk is a variable that can be modified, among others, by adjusting the type of product to be treated, the method of contacting the product with the enzyme, and the intended use of the product, the concentration of glucosyltransferase in the milk would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed concentration of glucosyltransferase cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the concentration of glucosyltransferase in the milk using a concentration of about 0.1% to about 10% as a guide to obtain the desired viscosity and mouthfeel in the resulting yogurt as taught by Schlothauer [0136] (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). “[W]here 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 In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.). Therefore, the claimed glucosyltransferase concentration in the milk is rendered obvious. Schlothauer teaches that the glucosyltransferase [0076] converts sucrose into polymers [0102] comprising glucose saccharides [0078]-[0081]; therefore, Schlothauer teaches that the glucosyltransferase forms a glucose polymer.
Schlothauer does not teach that: (A) the provided milk comprises 2-8 wt.% sucrose and 3.5-4.0 wt.% protein; (B) the glucosyltransferase enzyme has at least 95% sequence identity to SEQ ID NO:2 (GTF300); (C) the glucosyltransferase enzyme is GTF300; (D) the glucose polymer is an insoluble glucose polymer comprising alpha-1,3-glucan having at least 50% alpha-1,3 linkages and a DPw of 5-1600; (E) the starter culture is native and does not encode GTF300; or (F) the yogurt product has a thickness and mouthfeel that is each increased by at least 50% when compared to a control sample as recited in present claim 1, wherein the thickness is measured using the process recited in present claim 1.
However, Folkenberg discloses that yogurt is an old and well-known example of a food produced by the fermentation of lactic acid bacteria [0002]. Folkenberg discloses a well-known method of making yogurt comprising inoculating milk with a starter culture [0004]. Folkenberg teaches a method [0001] of making a yogurt product [0009], [0038] having improved texture in terms of increased thickness (corresponding to high viscosity and high gel stiffness) [0009] and increased mouthfeel [0054]. Folkenberg teaches that the method of making such a yogurt product comprises the step of: providing a milk substrate; adding sucrose to the milk substrate to form sweetened milk [0045]; contacting the sweetened milk substrate with a glucosyltransferase (corresponding to fermenting the milk substrate with Lactobacillus fermentum that produces glycosyltransferase); inoculating the milk substrate with a starter culture; and fermenting the milk substrate (corresponding to fermenting the milk substrate with Streptococcus thermophilus after fermentation with a Lactobacillus species) [0012]-[0013]. Folkenberg teaches that sucrose is added to the milk substrate so that the sucrose constitutes 5 wt.% of the milk substrate [0045], which falls within the claimed sucrose concentration. Folkenberg also teaches that the milk substrate may be a solution of cow’s milk and whey protein concentrate [0028], [0030]. Whey protein concentrate contains 25-89 wt.% protein as evidenced by Ladder (page 1, third paragraph under “Whey Protein Isolate vs. Concentrate”). A solution containing milk and whey protein concentrate can comprise protein in an amount greater than 0 wt.% to an amount less than 89 wt.%, which encompasses the claimed protein concentration. It would have been obvious to one of ordinary skill in the art to select any portions of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art references, particularly in view of the fact that; "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages" In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.I.
It would have been obvious for a person of ordinary skill in the art to have modified the method of Schlothauer to use a native starter culture not encoding GTF300. Since yogurt-making is an old and well-known process as disclosed by Folkenberg [0002], [0004], yogurt has long been produced by native starter cultures not comprising engineered enzymes such as GTF300 since such engineering technology to produce recombinant cultures and enzymes did not exist until the late 1900s. Therefore, it would have been obvious to use a native starter culture not encoding GTF300 since such cultures are well-known and have long been used in yogurt-making, thereby rendering the claimed native starter culture obvious. MPEP 2143.I.A.
It also would have been obvious for a person of ordinary skill in the art to have modified the method of Schlothauer to use milk comprising sucrose and protein to produce yogurt having improved thickness and mouthfeel as taught by Folkenberg. Since Schlothauer teaches that the fermentation medium is dairy milk from an animal, wherein the milk is sweetened with sucrose [0099], [0157], but does not disclose an animal from which to obtain the milk or an amount of sucrose in such milk, a skilled practitioner would have been motivated to consult an additional reference such as Folkenberg in order to determine a suitable animal source of milk and a suitable amount of sucrose to add to the milk to produce yogurt having improved thickness and mouthfeel, thereby rendering the claimed sucrose content obvious. In consulting Folkenberg, the practitioner would also find that the milk comprises protein in an amount which encompasses the claimed protein content, thereby rendering the claimed protein content obvious.
The combination of Schlothauer and Folkenberg does not teach that: the glucosyltransferase enzyme has at least 95% sequence identity to GTF300; the glucosyltransferase enzyme is GTF300; the glucose polymer is an insoluble glucose polymer comprising alpha-1,3-glucan having at least 50% alpha-1,3 linkages and a DPw of 5-1600; or that the yogurt product has a thickness and mouthfeel that is each increased by at least 50% when compared to a control sample as recited in present claim 1, wherein the thickness is measured using the process recited in present claim 1.
However, Payne teaches glucosyltransferases that catalyze sucrose to create glucose polymers [0015], [0019]; and teaches that a glucosyltransferase is GTF300 (corresponding to GTF Enzyme 6855 (SEQ ID NO:4)) [0082]. Payne teaches that the glucosyltransferases are isolated from the medium in which they are produced (corresponding to purified and/or isolated) [0057]-[0058] and form insoluble alpha-1,3-glucan [0066] having at least 50% alpha-1,3 glycosidic linkages and a DPw of at least about 100 [0035]-[0036], such as 440 (Table 2 under [0133]). This disclosed amount of alpha-1,3 glycosidic linkages and this exemplified DPw falls within the claimed ranges.
It would have been obvious for a person of ordinary skill in the art to have modified the method of Schlothauer to use the glucosyltransferase disclosed by Payne. Since Schlothauer teaches that the glucosyltransferase catalyzes sucrose [0085] and produces glucose polymers [0078]-[0081], but does not disclose a specific sequence of a glucosyltransferase that performs such functions, a skilled practitioner would have been motivated to consult an additional reference such as Payne in order to determine a suitable enzyme to catalyze sucrose polymerization and produce glucose polymers. In consulting Payne, the practitioner would find that its disclosed glucosyltransferases include a glucosyltransferase having 100% sequence identity to GTF300 [0082]; and that the disclosed glucosyltransferases synthesize insoluble alpha-1,3-glucan [0066] having at least 50% alpha-1,3 glycosidic linkages and a DPw of at least about 100 [0035]-[0036], such as 440 (Table 2 under [0133]). Therefore, the claimed glucosyltransferase and the claimed insoluble glucose polymer recited in present claims 1 and 15 are rendered obvious.
The combination of Schlothauer, Folkenberg, and Payne does not teach that the yogurt product has a thickness and mouthfeel that is each increased by at least 50% when compared to a control sample as recited in present claim 1, wherein the thickness is measured using the process recited in present claim 1. However, since the combination of prior art teaches the same method steps as claimed and instantly disclosed, the yogurt product produced by the method of the prior art would necessarily have the claimed increased thickness and mouthfeel. “It has long been the law that it can be assumed that a product produced by a process that is substantially identical to the process used to produce the claimed product inherently has the same properties as the claimed product. In re Spada, 911, F.2d 705, (Fed. Cir. 1990); In re King, 801 F.2d 1324, 1327 (Fed. Cir. 1986); In re Best, 562 F.2d 1252, 1255, 195 (CCPA 1977).” The Courts have held that it is well settled that where there is a reason to believe that a functional characteristic would be inherent in the prior art, the burden of proof then shifts to the applicant to provide objective evidence to the contrary. See In re Schreiber, 128 F .3d at 1478, 44 USPQ2d at 1478, 44 USPQ2d at 1432 (Fed. Cir. 1997). MPEP §2112.I.
Regarding claims 2, 3, and 4, modified Schlothauer teaches the invention as described above in claim 1, including the milk is cow’s milk (Folkenberg [0030]); and that the milk may be raw milk (Folkenberg [0028]).
Regarding claim 5, modified Schlothauer teaches the invention as described above in claim 3, including the method comprises the additional steps of homogenization and pasteurization of the milk (Folkenberg [0031]).
Regarding claim 6, modified Schlothauer teaches the invention as described above in claim 5, including the method comprises the additional steps of homogenization and pasteurization of the milk substrate prior to fermentation (Folkenberg [0031]). Folkenberg teaches that the milk substrate may be fermented with a first lactic acid bacteria and then subsequently fermented with a second lactic acid bacteria, wherein either the first or second lactic acid bacteria produces the glucosyltransferase (corresponding to fermenting the milk substrate with Streptococcus thermophilus before or after fermentation with a Lactobacillus species wherein the Lactobacillus species produces glucosyltransferase) [0013]. Since Folkenberg discloses homogenization and pasteurization of the milk substrate as occurring prior to fermentation; and discloses that glucosyltransferase is introduced into the milk substrate during fermentation, Folkenberg at least suggests a method wherein homogenization and pasteurization occur prior to contacting the milk substrate with glucosyltransferase, especially wherein it is known and practiced in the art to homogenize and pasteurize a substrate to be fermented with starter culture to denature unwanted proteins and to prevent organisms not part of the starter culture from interfering with the fermentation process. Therefore, Folkenberg teaches that the step of contacting the milk substrate with glucosyltransferase is performed after the steps of homogenization and pasteurization; thereby rendering the claim obvious.
Regarding claim 7, modified Schlothauer teaches the invention as described above in claim 5, including the method comprises heating the yogurt after fermentation to inactivate the bacteria (Folkenberg [0035]); and homogenizing the yogurt after fermentation to produce a stirred-type yogurt (Folkenberg [0037]). Folkenberg discloses pasteurization as being a heat treatment process used to inactivate bacteria [0033]. Folkenberg teaches that the milk substrate may be fermented with a first lactic acid bacteria and then subsequently fermented with a second lactic acid bacteria, wherein either the first or second lactic acid bacteria produces the glucosyltransferase (corresponding to fermenting the milk substrate with Streptococcus thermophilus before or after fermentation with a Lactobacillus species wherein the Lactobacillus species produces glucosyltransferase) [0013]. Since Folkenberg discloses that glucosyltransferase is introduced into the milk substrate during fermentation [0013]; and discloses homogenization and heat treatment of the yogurt after fermentation, wherein the heat treatment may be pasteurization [0033], [0035], [0037], Folkenberg at least suggests that the method may further comprise homogenization and pasteurization of the yogurt after contacting the milk substrate with the glucosyltransferase, thereby rendering the claim obvious.
Regarding claims 27, 28, 29, 30, 31, 35, 36, 37, 38, and 39, Schlothauer teaches the invention as described above in claim 1, including the glucosyltransferase increases mouthfeel and thickness (corresponding to viscosity) [0157]. Schlothauer also teaches that viscosity can be regulated through adjusting the amounts and ratios of sugars in the medium [0092]. Schlothauer also discloses that the viscosity is controlled through the pH of the fermentation medium [0100]. Schlothauer exemplifies viscosities of from greater than about 0 mPas to about 2500 mPas as a result of various sucrose concentrations (Fig. 5B); and viscosities from about 1600 mPas to about 2700 mPas as a result of various pH conditions (Fig. 15). As the viscosity is a variable that can be modified, among others, by adjusting the ratios of sugars and pH of the substrate, the viscosity would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed viscosity cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the viscosity in the yogurt of Schlothauer using viscosities of from greater than about 0 mPas to about 2700 mPas as a guide (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). MPEP 2144.05.II. Therefore, the claimed increased thickness recited in present claims 27, 28, 29, 30, and 31 are rendered obvious. Furthermore, since viscosity is a component of mouthfeel, mouthfeel is also a result effective variable as described above. Therefore, the claimed increased mouthfeel recited in present claims 35, 36, 37, 38, and 39 are also rendered obvious.
Regarding claim 86, Schlothauer teaches the invention as described above in claim 1, including the isolated glucosyltransferase is added to sucrose-fortified milk prior to fermentation [0157], thereby disclosing contacting the sweetened milk with the isolated glycosyltransferase. Folkenberg discloses that after introduction of the glycosyltransferase to the milk (corresponding to after fermentation of the milk by Lactobacillus species producing the glucosyltransferase), the milk may be fermented by the starter culture [0012]-[0013]. Therefore, the combination of Schlothauer and Folkenberg at least suggests that the step of contacting the sweetened milk with the isolated glucosyltransferase is performed prior to inoculation of the milk with the starter culture and in the absence of the starter culture as presently claimed.
Claims 40-52 and 88 are rejected under 35 U.S.C. 103 as being unpatentable over Schlothauer (US 2006/0057704; IDS citation) in view of Folkenberg (US 2014/0348980; IDS citation) and Payne (US 2015/0004650; previously cited) as evidenced by Ladder (“Whey Protein Isolate vs. Concentrate: Which is Better?, 2023, Ladder, https://ladder.sport/pages/whey-protein-isolate-vs-concentrate/; previously cited) as applied to claim 15 above, and further in view of Dairy (“Milk Pasteurization Process: What is Pasteurized Milk & Why”, 2015, US Dairy, https://www.usdairy.com/news-articles/why-is-milk-pasteurized-4-questions-answered; previously cited) and Hugunin (Hugunin, A., “U.S. Whey Ingredients in Yogurt and Yogurt Beverages”, 2009, U.S. Dairy Export Council).
Regarding claim 40, modified Schlothauer teaches the invention as described above in claim 15, including the method comprises heating the yogurt after fermentation to inactivate the bacteria (Folkenberg [0035]). Folkenberg discloses pasteurization as being a heat treatment process used to inactivate bacteria [0033]. Therefore, a skilled practitioner would readily recognize that the heat treatment after fermentation of the yogurt may be pasteurization. Folkenberg teaches that the process of pasteurization involves rapidly cooling the product [0032]. Folkenberg also teaches that the yogurt product may be a “stirred type product” that is produced by mechanical treatment after fermentation such as pumping, filtering, or homogenization [0037]. Schlothauer teaches that the product is packaged to preserve the yogurt during its shelf life [0077].
The prior art does not teach that the yogurt is chilled to a temperature of 5-10°C; or pouring the chilled yogurt into preformed containers.
However, Dairy teaches that pasteurization involves heating a dairy product to about 72°C and then chilling the product to about 4°C (page 1, paragraph 7).
It would have been obvious for a person of ordinary skill in the art to have modified the method of modified Schlothauer by cooling the yogurt product to 5-10°C as taught by Dairy. Since Folkenberg teaches that the yogurt product may be heat treated after fermentation to inactivate bacteria; pasteurization is a heat treatment that inactivates bacteria; and the product is chilled after pasteurization [0031]-[0032], but does not disclose temperatures for pasteurizing and chilling, a skilled practitioner would have been motivated to consult an additional reference such as Dairy in order to determine suitable temperatures for pasteurizing and chilling a dairy product. In consulting Dairy, the practitioner would understand that pasteurization involves heating the yogurt product to about 72°C and then chilling the product to about 4°C. Therefore, the yogurt product of Folkenberg is chilled to a temperature of 5-10°C on its way to reaching 4°C. Therefore, the claimed temperature of the chilled yogurt is rendered obvious.
The prior art does not teach pouring the chilled yogurt into preformed containers.
However, Hugunin teaches that stirred type yogurt is packaged after fermentation and mechanical treatment (page 2, Fig. 1); and that yogurt may be packaged in preformed containers (corresponding to cups or squeeze tubes) (page 3, 3rd column, 1st-2nd paragraphs under “Yogurt Packaging”).
It would have been obvious for a person of ordinary skill in the art to have modified the method of Schlothauer by pouring the chilled yogurt into a preformed container as taught by Hugunin. Since Schlothauer teaches that the yogurt product is packaged to preserve the yogurt during its shelf life [0077] and that the yogurt is pasteurized and chilled after fermentation [0035]; and Dairy teaches that the yogurt is chilled to about 4°C after pasteurization (page 1, paragraph 7), but the prior art does not disclose a type of packaging for the chilled yogurt, a skilled practitioner would have been motivated to consult an additional reference such as Hugunin in order to determine a suitable container that would preserve the freshness of the chilled yogurt product. Therefore, the claimed pouring of chilled yogurt into preformed container is rendered obvious.
Regarding claim 41, modified Schlothauer teaches the invention as described above in claim 40, including the containers may provide a single serving of yogurt (Hugunin, page 3, 1st paragraph under “Yogurt Packaging”).
Regarding claim 42, modified Schlothauer teaches the invention as described above in claim 40, including the milk is non-fat milk (corresponding to skim milk) (Folkenberg [0028]).
Regarding claims 43, 44, 45, 46, 47, and 48, modified Schlothauer teaches the invention as described above in claim 42, including that the milk substrate may be a solution of cow’s milk and whey protein concentrate (Folkenberg [0028], [0030]). Whey protein concentrate contains 25-89 wt.% protein as evidenced by Ladder (page 1, third paragraph under “Whey Protein Isolate vs. Concentrate”). A solution containing milk and whey protein concentrate can comprise protein in an amount greater than 0 wt.% to an amount less than 89 wt.%, which encompasses the claimed protein concentration. The selection of a value within this encompassing range renders the claimed concentrations obvious.
Regarding claim 49, Schlothauer teaches the invention as described above in claim 48, including a yogurt produced in according to claim 48 [0157].
Regarding claim 50, Schlothauer teaches the invention as described above in claim 49, including the yogurt further comprising pectin [0135].
Regarding claims 51 and 52, Schlothauer teaches the invention as described above in claim 48, including the milk comprises 10 wt.% lactose (Figures 8-10 on pages 10-12), which falls within the claimed lactose concentrations.
Regarding claim 88, modified Schlothauer teaches the invention as described above in claim 40, including the method comprises heating the yogurt after fermentation to inactivate the bacteria (Folkenberg [0035]). Folkenberg discloses pasteurization as being a heat treatment process used to inactivate bacteria [0033] so that a skilled practitioner would understand that the heat treatment performed after fermentation of the yogurt may be pasteurization. Pasteurization involves heating a dairy product to about 72°C and then chilling the product to about 4°C (Dairy, page 1, paragraph 7). Hugunin discloses filling containers with the chilled yogurt (page 2, Fig.1; page 3, 3rd column, 1st-2nd paragraphs under “Yogurt Packaging”). Therefore, the yogurt product of the prior art is chilled to a temperature of 5-10°C on its way to reaching 4°C; and then the yogurt product is filled into a container.
The prior art does not teach that the cooling of the yogurt product to 5-10°C prior to filling results in no loss of mouthfeel compared to filling at 24°C. However, such a result would be obvious since temperatures are typically inversely correlated to mouthfeel/viscosity of a yogurt product (i.e., the higher the temperature, the lower the mouthfeel/viscosity of the yogurt product so that yogurt at 24°C would have a lower mouthfeel/viscosity than the same yogurt product at 5-10°C).
Claim 87 is rejected under 35 U.S.C. 103 as being unpatentable over Schlothauer (US 2006/0057704; IDS citation) in view of Folkenberg (US 2014/0348980; IDS citation) and Payne (US 2015/0004650; previously cited) as evidenced by Ladder (“Whey Protein Isolate vs. Concentrate: Which is Better?, 2023, Ladder, https://ladder.sport/pages/whey-protein-isolate-vs-concentrate/; previously cited) as applied to claim 1 above, and further evidenced by Biology (“The Lactose Content in Milk and Dairy Products”, 2025, Biology Insights, https://biologyinsights.com/the-lactose-content-in-milk-and-dairy-products/).
Regarding claim 87, modified Schlothauer teaches the invention as described above in claim 1, including that the milk substrate is produced prior to addition of the enzyme (Schlothauer [0157]); and that the milk substrate may be a solution of cow’s milk and whey protein concentrate (Folkenberg [0028], [0030]). Cow’s milk typically contains 4.7-5 wt.% lactose as evidenced by Biology (page 1, 1st paragraph under “Lactose Levels in Various Milk Sources”). A solution containing milk and whey protein concentrate can comprise lactose in concentrations including from greater than 0 wt.% to less than 5 wt.%, which overlaps the claimed lactose concentration. The selection of a value within this overlapping range renders the claimed concentrations obvious. MPEP 2144.05.I.
Response to Arguments
Claim Rejections – 35 U.S.C. §103 of claims 1, 17, 26-31, and 34-39 over Schlothauer and Payne: Applicant’s amendments and arguments have been fully considered. Applicant’s amendments are not considered to overcome the current grounds of rejection. Applicant’s arguments are considered unpersuasive or moot in light of the new grounds of rejection.
Applicant canceled claims 17, 26, and 34. Applicant amended claim 1 and argued that the amended claim overcomes the combination of Schlothauer and Payne as the amended claim recites a method that produces rheological outcomes that are not disclosed by the combination of Schlothauer and Payne. Applicant argued that the disclosure of Schlothauer centers on compositions in which lactic acid bacteria, an enzyme produced by that bacteria, and EPS are grown together in a growth medium, not milk as required by the present claims. Applicant pointed to confirmation by the PTAB in the PTAB Decision filed 11/20/2025 for support in this stance. Applicant stated that the amended claim requires contacting a sweetened milk with an isolated glucosyltransferase to produce an insoluble glucose polymer in the milk and to produce a specific viscosity and mouthfeel in the milk, wherein the polymer has the features recited in the amended claim and wherein the thickness and mouthfeel are measured using the method recited in the amended claim. Since the amended claim requires the enzyme to be added to milk, not a growth medium as disclosed by Schlothauer, Applicant argued that the amended claim moves out of Schlothauer’s LAB context (Applicant’s Remarks, page 8, 1st paragraph under section IV – page 9, 1st paragraph).
However, the Examiner points out that the PTAB decision stated that the Examiner’s reliance on Figure 5B for discloses the claimed minimum 50% increase in thickness and mouthfeel was erroneous. The PTAB agreed with the Examiner for reliance on Schlothauer for disclosing the inclusion of an isolated glucosyltransferase in a sweetened milk (PTAB Decision, page 6, 1st-2nd paragraphs). For at least this reason, Schlothauer discloses contacting a sweetened milk with an isolated glucosyltransferase to produce an insoluble glucose polymer in the milk as recited in amended claim 1.
Applicant then stated that amended claim 1 now requires the glucosyltransferase to have at least 95% sequence identify to GTF300. Applicant argued that neither Schlothauer nor Payne discloses GTF300 for forming insoluble α-1,3-glucan in milk. Applicant argued that Payne discloses that many of its GTFs fail to produce insoluble glucan with a high α-1,3 content so that the claimed enzyme selection is not obvious to try. Applicant also argued that the enzyme dose of about 0.3 mg to about 5 mg per 100 ml milk as now recited by amended claim 1 is not trivial optimization as the dosage is tied to the milk-specific performance documented in the present specification (Applicant’s Remarks, page 9, 2nd paragraph).
However, in response to the assertion that neither Schlothauer nor Payne discloses GTF300 for forming insoluble α-1,3-glucan in milk one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). As described above in the rejection of amended claim 1, Schlothauer teaches that the glucosyltransferase used in its sucrose-sweetened milk catalyzes sucrose [0085], [0157] and produces glucose polymers [0078]-[0081], but does not disclose a specific sequence of a glucosyltransferase that performs such functions. Therefore, a skilled practitioner would have been motivated to consult an additional reference such as Payne in order to determine a suitable enzyme to catalyze sucrose polymerization and produce glucose polymers. In consulting Payne, the practitioner would find that the glucosyltransferases disclosed in Payne include a glucosyltransferase having 100% sequence identity to GTF300 (corresponding to GTF Enzyme 6855 (SEQ ID NO:4)) [0082]; and that the disclosed glucosyltransferases synthesize insoluble alpha-1,3-glucan [0066] having at least 50% alpha-1,3 glycosidic linkages and a DPw of at least about 100 [0035]-[0036]. Therefore, the combination of Schlothauer and Payne renders the addition of GTF300 to milk obvious; and Applicant’s arguments regarding that neither Schlothauer nor Payne discloses GTF300 for forming insoluble α-1,3-glucan in milk are unpersuasive.
In response to Applicant’s assertion that Payne discloses that many of its GTFs fail to produce insoluble glucan with a high α-1,3 content so that the claimed enzyme selection is not obvious to try, Payne discloses that GTF300 produced an insoluble glucose polymer comprising 100% alpha-1,3 glycosidic linkages and a DPw of 440 in a sucrose solution ([0132]; Table 2 under [0133]). Since GTF300 produced the highest possible amount of alpha-1,3 glycosidic linkages in a sucrose solution, a skilled practitioner would be further motivated to select GTF300 from the GTFs of Payne to produced alpha-1,3 glycosidic linkages in sucrose-containing milk. Therefore, Applicant’s arguments regarding the claimed enzyme selection is not obvious to try is unpersuasive.
In response to the assertion that that the enzyme dose of about 0.3 mg to about 5 mg per 100 ml milk as now recited by amended claim 1 is not trivial optimization as the dosage is tied to the milk-specific performance documented in the present specification, Schlothauer teaches that the amount of glucosyltransferase present in the milk will depend on the product to be treated, the method of contacting the product with the composition, the intended use of the product [0136]. Schlothauer also exemplifies an amount of glucosyltransferase of about 0.1% to about 10% in the yogurt milk [0157]. As the amount of glucosyltransferase in the milk is a variable that can be modified, among others, by adjusting the type of product to be treated, the method of contacting the product with the enzyme, and the intended use of the product, the concentration of glucosyltransferase in the milk would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed concentration of glucosyltransferase cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the concentration of glucosyltransferase in the milk using a concentration of about 0.1% to about 10% as a guide to obtain the desired viscosity and mouthfeel in the resulting yogurt as taught by Schlothauer [0136].
Therefore, the claimed glucosyltransferase concentration in the milk is rendered obvious, especially in light of the present specification: (a) disclosing the enzyme concentration of about 0.005 mg per 100 ml milk to about 15 mg per 100 ml milk to be an optional or preferable amount (specification, page 3, lines 14-17; page 30, lines 21-22); (b) not providing results of any example compositions wherein the concentration of GTF300 in the milk is at, near, or below the claimed minimum concentration of about 0.3 mg per 100 ml milk; and (c) a dose of 7.5 mg enzyme per 100 ml milk (corresponding to double dosage) being the only enzyme concentration outside of the claimed range being tested and the 7.5 mg enzyme per 100 ml milk providing the claimed amount of increased viscosity and mouthfeel. “To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960).” MPEP 716.02(d).II. The single 7.5 mg enzyme per 100 ml milk dosage does not amount to “a sufficient number of tests” outside of the claimed range, especially wherein no concentration at and below the claimed minimum concentration was tested; and the single concentration outside of the claimed concentration range provided the claimed results. For at least these reasons, the claimed enzyme concentration is not considered to be critical to the invention and Applicant’s arguments regarding such are unpersuasive.
Applicant then argued that the features now recited by amended claim 1 distinguish the claimed process from Payne’s buffered systems and Schlothauer’s LAB medium, both of which lack lactose acceptor effects and matrix-dependent rheology. Applicant argued that the use of a starter culture that does not encode GFT300 as now recited by amended claim 1 excludes situations where the lactic acid bacteria give rise to the active enzyme as disclosed by Schlothauer (Applicant’s Remarks, page 9, 3rd paragraph).
However, in the new grounds of rejection necessitated by the rejection of amended claim 1, the features of amended claim 1 are rendered obvious by the combination of Schlothauer, Payne, and Folkenberg as evidenced by Ladder. As described above in the rejection of amended claim 1, since the yogurt of Schlothauer is produced by fermenting the sweetened milk containing the glucosyltransferase [0157], then the method of Schlothauer comprises a step of inoculating the milk with a starter culture prior to fermentation. Yogurt-making is an old and well-known process as disclosed by Folkenberg [0002], [0004] so that yogurt has long been produced by native starter cultures not comprising engineered enzymes such as GTF300 since such engineering technology to produce recombinant organisms and proteins did not exist until the late 1900s. Therefore, it would have been obvious to use a native starter culture not encoding GTF300 since such cultures are well-known and have long been used in yogurt-making, thereby rendering the claimed native starter culture obvious. MPEP 2143.I.A.
In response to Applicant’s assertion that that the features now recited by amended claim 1 distinguish the claimed process from Payne’s buffered systems and Schlothauer’s LAB medium, both of which lack lactose acceptor effects and matrix-dependent rheology, the prior art is shown to use sucrose-containing milk as recited in amended claim 1 (Schlothauer [0157]) as described in the rejection of amended claim 1 and in the responses above. Furthermore, it is noted that amended claim 1 is not required to have lactose acceptor effects as amended claim 1 does not require the milk to contain lactose at all. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant then argued that the amendments of claim 1 foreclose inherency of the claimed improved thickness and mouthfeel of the yogurt product because the prior art does not produce the claimed results under the milk-specific conditions and definitions. Applicant further rebutted the inherency stance by arguing: (1) that the matrix of the prior art is different than the claimed milk matrix; (2) that neither Schlothauer nor Payne disclose measuring viscosity using the protocol recited in amended claim 1; (3) that amended claim 1 requires the enzyme to have at least 95% sequence identity to GTF300 and requires an enzyme concentration of 0.3-5 mg per 100 ml milk; and (4) the examples in the present specification demonstrate that the dual minimum 50% improvement in thickness and mouthfeel are not the natural results of Schlothauer and Payne. Applicant also argued that the specification documents unexpected results in improvement in mouthfeel and thickness that contradict any “routine optimization” theory. Applicant further argued surprising and unexpected results in that the claimed GTF produced at least 50% increases in viscosity and mouthfeel relative to the control samples which did not contain GTF. Applicant argued that this feature is not anticipated by the approaches of Schlothauer and Payne. Applicant argued that this increased thickness and mouthfeel have benefits during pasteurization, homogenization, and cooling prior to filling in real-world yogurt processing (Applicant’s Remarks, page 9, 4th paragraph - page 10, 1st paragraph; page 13-15, sections VI-VII).
However, as described above in the rejection amended claim 1, the features of amended claim 1 are now rendered obvious by the combination of Schlothauer, Folkenberg, and Payne as evidenced by Ladder. The combination of Schlothauer, Folkenberg, and Payne does not teach that the yogurt product has a thickness and mouthfeel that is each increased by at least 50% when compared to a control sample as recited in present claim 1, wherein the thickness is measured using the process recited in present claim 1. However, since the combination of prior art teaches the same method steps as claimed and instantly disclosed, the yogurt product produced by the method of the prior art would necessarily have the claimed increased thickness and mouthfeel. “It has long been the law that it can be assumed that a product produced by a process that is substantially identical to the process used to produce the claimed product inherently has the same properties as the claimed product. In re Spada, 911, F.2d 705, (Fed. Cir. 1990); In re King, 801 F.2d 1324, 1327 (Fed. Cir. 1986); In re Best, 562 F.2d 1252, 1255, 195 (CCPA 1977).” MPEP §2112.I. Since the claimed method is rendered obvious by a new combination of prior art and thus, the inherency of the claimed method is rendered obvious by a new combination of prior art, Applicant’s arguments regarding inherency are moot.
In response to Applicant’s assertions that the specification documents unexpected results in improvement in mouthfeel and thickness that contradict any “routine optimization” theory, it is not clear how the results stemming from the inclusion of GTF in the yogurt milk to produce yogurt having increased thickness and mouthfeel are unexpected since it is known in the art that GTF produces EPS and EPS increases viscosity/thickness/mouthfeel in yogurt (Schlothauer [0082], [0085]). Furthermore, in response to Applicant’s assertions that the claimed increased thickness and mouthfeel have benefits during pasteurization, homogenization, and cooling prior to filling in real-world yogurt processing, amended claim 1 does not require such processing steps. For at least these reasons, Applicant’s arguments regarding unexpected results are unpersuasive.
Since the prior art has been shown to render the claims obvious, and Applicant’s arguments have been shown to be unpersuasive or moot, the rejection of the claims stand as written herein.
Claim Rejections – 35 U.S.C. §103 of claims 2-15 and 18-23 over Schlothauer and Folkenberg; Applicant’s arguments have been fully considered and are considered unpersuasive.
Applicant canceled claims 8-14 and 18-23. Applicant argued that Folkenberg does not remedy the aforementioned deficiency of Schlothauer regarding the disclosure of Schlothauer centering on compositions in which lactic acid bacteria, an enzyme produced by that bacteria, and EPS are grown together in a growth medium, not milk as required by the present claims (Applicant’s Remarks, page 10, 2nd-5th paragraphs).
However, as described in the response above, the PTAB agreed with the Examiner for reliance on Schlothauer for disclosing the inclusion of an isolated glucosyltransferase in a sweetened milk (PTAB Decision, page 6, 1st-2nd paragraphs). For at least this reason, Schlothauer discloses contacting a sweetened milk with an isolated glucosyltransferase to produce an insoluble glucose polymer in the milk as recited in amended claim 1. Since there is no deficiency in Schlothauer regarding using the isolated enzyme in milk, Folkenberg is not needed to remedy such a deficiency and Applicant’s arguments regarding such are unpersuasive.
It is noted that the rejections of claims 8-14 and 18-23 are moot due to the cancelation of these claims. The rejections of the remaining claims stand rejected over new grounds of rejection necessitated by the amendment of claim 1.
Claim Rejections – 35 U.S.C. §103 of claims 40-42 over Schlothauer, Payne, Folkenberg, Kennedy, and Dairy: Applicant’s arguments have been fully considered and are considered unpersuasive.
Applicant argued that Kennedy and Dairy do not remedy the aforementioned deficiencies of Schlothauer and Payne as discussed in relation to amended claim 1 (page 10, 6th – page 11, 1st paragraph).
However, in the new grounds of rejection necessitated by the amendment of claim 1, the combination of prior art is shown to render the features of amended claim 1 obvious. Therefore, Applicant’s arguments are unpersuasive and the rejections of the claims stand as written herein.
Claim Rejections – 35 U.S.C. §103 of claims 43-52 over Schlothauer, Payne, Folkenberg, Kennedy, and Dairy as evidenced by Ladder: Applicant’s arguments have been fully considered and are considered unpersuasive.
Applicant argued that Ladder does not remedy the aforementioned deficiencies of Schlothauer and Payne as discussed in relation to amended claim 1 (page 11, 2nd-3rd paragraphs).
However, in the new grounds of rejection necessitated by the amendment of claim 1, the combination of prior art is shown to render the features of amended claim 1 obvious. Therefore, Applicant’s arguments are unpersuasive and the rejections of the claims stand as written herein.
New Claims 86-88: Applicant argued that the new claims recite features not disclosed in the cited prior art (Applicant’s Remarks, page 12, section V).
However, claims 86-88 are rendered obvious as described in their rejections written above.
Conclusion
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/KELLY P KERSHAW/Examiner, Art Unit 1791