DETAILED ACTION
Amendments made October 7, 2025 have been entered.
Claims 1-9, 11-13, 16-21, and 23 are pending.
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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The rejection of claim 8 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joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention has been withdrawn in light of applicant’s amendments made October 7, 2025.
Claim Rejections - 35 USC § 103
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, 9, 11-13, 16-21, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Von Niessen (US 2012/0244258) in view of Igoe et al (Dictionary of Food Ingredients 4th Edition, pages 40, 71, 72, 75, 88, and 139) and Fennema (Fenenma’s Food Chemistry 4th Edition pages 129, 130, and 726), and as evidenced by Indiana Sugars (“Bulk Corn syrup” https://www.sugars.com/product-catalog/all-products/corn-syrup pages 1-14) and Think USA Dairy (https://www.thinkusadairy.org/products/milk-powders/milk-powder-categories/dry-whole-milk-and-whole-milk-powder pages 1-2) and Shakerdi et al (“Determination of the lactose and galactose content of common foods: Relevance to galactosemia” pages 3789-3800).
Von Niessen teaches a core confection comprising: a) 0.5-10% protein selected from gelatin which hydrocolloid or whey protein which is a milk solid; b) preferably 65-82% carbohydrates in the form of crystalline and non-crystalline carbohydrates; c) 10-30% water (abstract and paragraphs 8 and 51); and preferably 0.1-44% of at least one additional component e) selected from the group including powdered milk (paragraphs 36 and 37). It is noted that although the water in the non-crystalline carbohydrate phase is in addition to the water identified in feature c, as Von Niessen teaches in an especially preferred embodiment the dry matter of the core confection is 70-90% (paragraphs 19 and 20), the teachings of Von Niessen still encompass a total water content of 10-30%.
Regarding the composition as comprising 15.0-35.0% milk solids as recited in claim 1, preferably 18.0-35.0% milk solids as recited in claim 12, Von Niessen teaches the core confection comprising: a) 0.5-10% protein which is whey protein which is a milk solid and preferably 0.1-44% of at least one additional component e) selected from the group including powdered milk (paragraphs 22, 36, 37 and 51). Thus, it would have been obvious suggestion of the prior art to use known powdered milks, including skim or whole milk powder. As evidenced by Think USA Dairy, dry whole milk or whole milk powder was known to typically contain 36.0-38.5% fat, 36.0-38.5% lactose, and 66-72% milk solids (protein, lactose and ash) (table, page 1). Thus, the addition of 0.1-44% milk solids as taught by Von Niessen would contribute 0.066-31.68% milk solids to the core confectionary composition, and the core composition would comprise a total of 0.566-41.68% milk solids from the protein and/or the additional milk solid ingredient. The teachings of Von Niessen encompass an overlapping range of milk solids. 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.
Regarding the composition as comprising less than 25% sucrose as recited in claim 1, preferably less than or equal to 19% as recited in claim 4, or greater than or equal to 5.0% as recited in claim 2, or greater than or equal to 10.0% as recited in claim 3; 20.0-45.0% of a combination of at least two L-glucose, D-glucose (i.e. dextrose), fructose, maltose, and maltotriose as recited in claim 1, preferably 22.0-40.0% of the combination as recited in claim 9; 10.0-25.0% dextrose as recited in claim 16, or 5.0-25.0% fructose as recited in claim 17, or 0.02-2.5% maltose as recited in claim 18, or 0.02-2.5% maltotriose as recited in claim 19, 2.5-15.0% glucose syrup with a DE of 35-95 as recited in claim 6, or corn syrup, i.e. glucose syrup as recited in claim 5, or 45.0-65.0% non-milk based carbohydrates as recited in claim 21, Von Niessen teaches the crystalline carbohydrate comprises saccharose, i.e. sucrose, and glucose, i.e. dextrose or D-glucose, and/or isomaltulose (paragraph 10), wherein in a preferred embodiment the weight of sucrose in the crystalline carbohydrate phase is 40-45% (paragraph 13), and in a preferred embodiment the weight of glucose, i.e. dextrose is from 5-25% of the crystalline carbohydrate phase (paragraph 17). Von Niessen teaches the non-crystalline carbohydrate is preferably glucose syrup (paragraph 10), but may be selected from the group including invert sugar syrup, high fructose corn syrup, glucose syrup, or a combination thereof (paragraph 54), and that the non-crystalline carbohydrate phase has a dry matter content of 60-90% (paragraph 19). Von Niessen teaches the carbohydrate component comprises 60-90% crystalline carbohydrate and 10-40% non-crystalline carbohydrate based on the dry weight of carbohydrate component (paragraphs 11 and 12).
Von Niessen is silent to the type of corn syrup used, however, Fennema teaches that a DE of 42 is most common and these syrups are stable because crystallization does not occur easily in such mixtures (page 130 first paragraph). It would have been obvious to one of ordinary skill in the art for the generally disclosed corn syrup of Von Niessen to be the most common, i.e. one with a DE of about 42 as taught by Fennema as it was stable because crystallization does not occur. As no limitations were placed on the corn syrup component, to use a known and common corn syrup would have been obvious to one of ordinary skill in the art. As evidenced by Indiana Sugars 42DE corn syrup contains by dry weight 20% dextrose, 13% maltose, and 12% maltotriose (page 2), and 80.5% solids (page 9), and thus by total weight, the corn syrup contains 16.1% dextrose, 10.465% maltose and 9.66% maltotriose.
With the corn syrup type identified, the core confectionary composition taught by Von Niessen can be calculated, and based on those teachings, the prior discloses overlapping ranges. It is noted that as the crystalline carbohydrate is a dry product it was calculated as having negligible moisture; and that a range of 0% sucrose is encompassed by the sucrose values recited in claims 1 and 4. For example, at 65% of the carbohydrate composition composed of about 47.37% crystalline carbohydrates and about 52.63% non-crystalline carbohydrates, i.e. corn syrup, with a solids content of 60%, the carbohydrate component would comprise about 60% dry weight crystalline carbohydrates and about 40% non-crystalline carbohydrates, and the core confection would comprise about 12% sucrose (from 45% sucrose in the crystalline sugar), and about 20% dextrose, maltose, and maltotriose, including about 13.2% dextrose (from corn syrup, i.e. glucose syrup, and 25% dextrose in the crystalline carbohydrate). 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.
Furthermore, the teachings of Von Niessen disclose various ranges of sucrose and dextrose as crystalline sugars as well as various ranges of dextrose, maltose, maltotriose, and fructose, which are contributed from the disclosed non-crystalline carbohydrates in varying amounts.
Fennema teaches that hydrolysis of starch produces sugar syrup, wherein hydrolysis DE values of 20-60 gives corn syrups which are mildly sweet (page 129 last paragraph) and continued hydrolysis produces a mixture of D-glucose, maltose, and other malto-oligosaccahrides (page 130, first paragraph). Fennema teaches that a DE of 42 is most common and these syrups are stable because crystallization does not occur easily in such mixtures (page 130 first paragraph). Fennema additionally teaches that as greater hydrolysis occurs there is less viscosity and body, less sugar crystallization prevention, more sweetness, more hygroscopicity and humectancy, and greater flavor enhancement (page 129, Table 3.7). Fennema teaches that in intermediate moisture foods, i.e. foods with a moisture content of 15-30%, sucrose and glucose are of value because they are sufficiently effective at lowering water activity and being tolerable organoleptically (page 726, paragraph 1).
Igoe et al (Igoe) teaches corn syrup contains maltose, dextrose, and other polysaccharides; that although less sweet, corn syrup is used to replace sucrose; and that it can control crystallization in candy making (page 40). Igoe teaches high-fructose corn syrup contains varying concentrations of fructose in mixture with dextrose, maltose, and other saccharides (pages 71-72). Igoe teaches invert sugar is a mixture of glucose and fructose, is more soluble, sweeter, and crystalizes less readily than sucrose (page 75). Igoe teaches sucrose is a universal sweetener because of its intense sweetness and solubility (page 139). Igoe teaches maltose was a sweetener consisting of dextrose which is less sweet and more stable than sucrose (page 88).
As the different carbohydrates taught by Von Niessen were known to each respectively contribute different benefits to the final product as shown by Igoe and/or Fennema, it would have been obvious to adjust the carbohydrates disclosed by Von Niessen, including high fructose corn syrup, corn syrup, sucrose, and dextrose depending on the desired sweetness, crystallization prevention, body, water activity, and stability desired. In adjusting the amount of syrup component(s), the compositional amount of the syrup(s) elements, including dextrose, fructose, maltose, and maltotriose would also be adjusted in the final product. It is noted that the claims do not limit the form of the claimed sugars or require that they be in insolated form. In fact, the instant disclosure exemplifies the carbohydrates, such as maltose and maltotriose as added in a syrup form, such as inverted sugar syrup, to reduce crystallization and increase stability (instant application page 1 lines 8-12, page 3 lines 13-19, and examples 1 and 2), and thus it appears applicant is doing nothing more than adjusting known ingredients to produce known results.
Regarding the composition as comprising 1.5-4.5% galactose as recited in claim 1, as discussed above, Von Niessen teaches a core confectionary composition comprising 0.036-16.95% lactose from the use of milk powder. Galactose and glucose form lactose. As evidenced by Shakerdi et al, page 3790, lactose contains 52.63% galactose (526mg/1000mg). Thus, the composition of Von Niessen comprises 0.019-8.87% galactose. It is noted that the claim does not limit the form of the galactose, only that it be present in some manner within the composition. In fact, the instant disclosure exemplifies the galactose as added from milk powder (examples 1 and 2).
Regarding the composition as free of hydrocolloids as recited in claim 11, as the product of Von Niessen does not require the use of hydrocolloids, the product of the prior art would encompass one free of hydrocolloids as claimed. To form the product of the prior art as disclosed and without any additional non-required components would have been an obvious suggestion of the prior art.
Regarding claim 13, as discussed above, Von Niessen teaches a core confectionary composition. Von Niessen teaches that the core confection contains preferably 0.1-44% of at least one additional component e) selected from the group including powdered milk (paragraphs 36 and 37). Thus, it would have been obvious suggestion of the prior art to use known powdered milks, including skim or whole milk powder. As evidenced by Think USA Dairy, dry whole milk or whole milk powder was known to typically contain 36.0-38.5% fat, 36.0-38.5% lactose, and 66-72% milk solids (protein, lactose and ash) (table, page 1). Thus, the addition of 0.1-44% milk solids as taught by Von Niessen would contribute 0.026-17.6% milk fat and 0.036-16.95% lactose to the core confectionary composition.
Regarding claim 20, as discussed above, Von Niessen teaches a core confectionary composition. Von Niessen teaches that the core confection contains: b) preferably 65-82% carbohydrates in the form of crystalline and non-crystalline carbohydrates; and preferably 0.1-44% of at least one additional component e) selected from the group including powdered milk (paragraphs 36 and 37). Thus, it would have been obvious suggestion of the prior art to use known powdered milks, including skim or whole milk powder. As evidenced by Think USA Dairy, dry whole milk or whole milk powder was known to typically contain 36.0-38.5% fat, 36.0-38.5% lactose, and 66-72% milk solids (protein, lactose and ash) (table, page 1). Thus, the addition of 0.1-44% milk solids as taught by Von Niessen would contribute 0.036-16.95% lactose, which is a carbohydrate, to the core confectionary composition, and the core composition would comprise a total of 65.036-98.95% total carbohydrates.
Von Niessen discloses overlapping ranges. 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.
Claims 2-4, 7-9, 11-13, 16-21, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Von Niessen (US 2012/0244258) in view of White (“Straight talk about high-fructose corn syrup: what it is and what it ain’t” American Society for Nutrition 2008, pages 1716S-1721S) and Igoe et al (Dictionary of Food Ingredients 4th Edition, pages 40, 71, 72, 75, 88, and 139) and Fennema (Fenenma’s Food Chemistry 4th Edition pages 129, 130, and 726), and as evidenced by Think USA Dairy (https://www.thinkusadairy.org/products/milk-powders/milk-powder-categories/dry-whole-milk-and-whole-milk-powder pages 1-2) and Shakerdi et al (“Determination of the lactose and galactose content of common foods: Relevance to galactosemia” pages 3789-3800).
Von Niessen teaches a core confection comprising: a) 0.5-10% protein selected from gelatin which hydrocolloid or whey protein which is a milk solid; b) preferably 65-82% carbohydrates in the form of crystalline and non-crystalline carbohydrates; c) 10-30% water (abstract and paragraphs 8 and 51); and preferably 0.1-44% of at least one additional component e) selected from the group including powdered milk (paragraphs 36 and 37). It is noted that although the water in the non-crystalline carbohydrate phase is in addition to the water identified in feature c, as Von Niessen teaches in an especially preferred embodiment the dry matter of the core confection is 70-90% (paragraphs 19 and 20), the teachings of Von Niessen still encompass a total water content of 10-30%.
Regarding the composition as comprising 15.0-35.0% milk solids as recited in claim 1, preferably 18.0-35.0% milk solids as recited in claim 12, Von Niessen teaches the core confection comprising: a) 0.5-10% protein which is whey protein which is a milk solid and preferably 0.1-44% of at least one additional component e) selected from the group including powdered milk (paragraphs 22, 36, 37 and 51). Thus, it would have been obvious suggestion of the prior art to use known powdered milks, including skim or whole milk powder. As evidenced by Think USA Dairy, dry whole milk or whole milk powder was known to typically contain 36.0-38.5% fat, 36.0-38.5% lactose, and 66-72% milk solids (protein, lactose and ash) (table, page 1). Thus, the addition of 0.1-44% milk solids as taught by Von Niessen would contribute 0.066-31.68% milk solids to the core confectionary composition, and the core composition would comprise a total of 0.566-41.68% milk solids from the protein and/or the additional milk solid ingredient. The teachings of Von Niessen encompass an overlapping range of milk solids. 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.
Regarding the composition as comprising less than 25% sucrose as recited in claim 1, preferably less than or equal to 19% as recited in claim 4, or greater than or equal to 5.0% as recited in claim 2, or greater than or equal to 10.0% as recited in claim 3; 20.0-45.0% of a combination of at least two L-glucose, D-glucose (i.e. dextrose), fructose, maltose, and maltotriose as recited in claim 1, preferably 22.0-40.0% of the combination as recited in claim 9; 10.0-25.0% dextrose as recited in claim 16, or 5.0-25.0% fructose as recited in claim 17, or 0.02-2.5% maltose as recited in claim 18, or 0.02-2.5% maltotriose as recited in claim 19, 20.0-45.0% fructose corn syrup as recited in claim 8, or 45.0-65.0% non-milk based carbohydrates as recited in claim 21, Von Niessen teaches the crystalline carbohydrate comprises saccharose, i.e. sucrose, and glucose, i.e. dextrose or D-glucose, and/or isomaltulose (paragraph 10), wherein in a preferred embodiment the weight of sucrose in the crystalline carbohydrate phase is 40-45% (paragraph 13), and in a preferred embodiment the weight of glucose, i.e. dextrose is from 5-25% of the crystalline carbohydrate phase (paragraph 17). Von Niessen teaches the non-crystalline carbohydrate is preferably glucose syrup (paragraph 10), but may be selected from the group including invert sugar syrup, high fructose corn syrup, glucose syrup, or a combination thereof (paragraph 54), and that the non-crystalline carbohydrate phase has a dry matter content of 60-90% (paragraph 19). Von Niessen teaches the carbohydrate component comprises 60-90% crystalline carbohydrate and 10-40% non-crystalline carbohydrate based on the dry weight of carbohydrate component (paragraphs 11 and 12).
Von Niessen is silent to the type of high fructose corn syrup (HFCS) used; however, White teaches the most common sweetener and important high fructose products are HFCS 42 and 55 (Page 1717S, Table 1 and Composition, paragraph 1). It would have been obvious to one of ordinary skill in the art for the generally disclosed high fructose corn syrup of Von Niessen to be a common high fructose corn syrup, i.e. one with a fructose content of 55%, dextrose content of 42%, and 3% remaining carbohydrates predominantly of maltose and maltotriose, as taught by White (Page 1717S, Table 1 and Composition, paragraph 1). As no limitations were placed on the high fructose corn syrup component, to use a known and common corn syrup would have been obvious to one of ordinary skill in the art.
With the HFCS identified, the core confectionary composition taught by Von Niessen can be calculated, and based on those teachings, the prior discloses overlapping ranges. It is noted that as the crystalline carbohydrate is a dry product it was calculated as having negligible moisture. For example, at about 63% of the dry carbohydrate composition composed of about 6-90% crystalline carbohydrates and about 10-40% non-crystalline carbohydrates, i.e. HFCS as taught by White, the core confection would comprise about 15-26% sucrose (from 40-45% sucrose in the crystalline sugar), and about 9-35% dextrose, maltose, and maltotriose, including about 0.19-0.76% maltose and maltotriose, about 3.5-13.9% fructose, and 5.5-20% dextrose (from the crystalline sugar and HFCS). 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.
Furthermore, the teachings of Von Niessen disclose various ranges of sucrose and dextrose as crystalline sugars as well as various ranges of dextrose, maltose, maltotriose, and fructose, which are contributed from the disclosed non-crystalline carbohydrates in varying amounts.
Fennema teaches that hydrolysis of starch produces sugar syrup, wherein hydrolysis DE values of 20-60 gives corn syrups which are mildly sweet (page 129 last paragraph) and continued hydrolysis produces a mixture of D-glucose, maltose, and other malto-oligosaccahrides (page 130, first paragraph). Fennema teaches that a DE of 42 is most common and these syrups are stable because crystallization does not occur easily in such mixtures (page 130 first paragraph). Fennema additionally teaches that as greater hydrolysis occurs there is less viscosity and body, less sugar crystallization prevention, more sweetness, more hygroscopicity and humectancy, and greater flavor enhancement (page 129, Table 3.7). Fennema teaches that in intermediate moisture foods, i.e. foods with a moisture content of 15-30%, sucrose and glucose are of value because they are sufficiently effective at lowering water activity and being tolerable organoleptically (page 726, paragraph 1).
Igoe et al (Igoe) teaches corn syrup contains maltose, dextrose, and other polysaccharides; that although less sweet, corn syrup is used to replace sucrose; and that it can control crystallization in candy making (page 40). Igoe teaches high-fructose corn syrup contains varying concentrations of fructose in mixture with dextrose, maltose, and other saccharides (pages 71-72). Igoe teaches invert sugar is a mixture of glucose and fructose, is more soluble, sweeter, and crystalizes less readily than sucrose (page 75). Igoe teaches sucrose is a universal sweetener because of its intense sweetness and solubility (page 139). Igoe teaches maltose was a sweetener consisting of dextrose which is less sweet and more stable than sucrose (page 88).
As the different carbohydrates taught by Von Niessen were known to each respectively contribute different benefits to the final product as shown by Igoe and/or Fennema, it would have been obvious to adjust the carbohydrates disclosed by Von Niessen, including high fructose corn syrup, corn syrup, sucrose, and dextrose depending on the desired sweetness, crystallization prevention, body, water activity, and stability desired. In adjusting the amount of syrup component(s), the compositional amount of the syrup(s) elements, including dextrose, fructose, maltose, and maltotriose would also be adjusted in the final product. It is noted that the claims do not limit the form of the claimed sugars or require that they be in insolated form. In fact, the instant disclosure exemplifies the carbohydrates, such as maltose and maltotriose as added in a syrup form, such as inverted sugar syrup, to reduce crystallization and increase stability (instant application page 1 lines 8-12, page 3 lines 13-19, and examples 1 and 2), and thus it appears applicant is doing nothing more than adjusting known ingredients to produce known results.
Regarding the composition as comprising 1.5-4.5% galactose as recited in claim 1, as discussed above, Von Niessen teaches a core confectionary composition comprising 0.036-16.95% lactose from the use of milk powder. Galactose and glucose form lactose. As evidenced by Shakerdi et al, page 3790, lactose contains 52.63% galactose (526mg/1000mg). Thus, the composition of Von Niessen comprises 0.019-8.87% galactose. It is noted that the claim does not limit the form of the galactose, only that it be present in some manner within the composition. In fact, the instant disclosure exemplifies the galactose as added from milk powder (examples 1 and 2).
Regarding the composition as free of hydrocolloids as recited in claim 11, as the product of Von Niessen does not require the use of hydrocolloids, the product of the prior art would encompass one free of hydrocolloids as claimed. To form the product of the prior art as disclosed and without any additional non-required components would have been an obvious suggestion of the prior art.
Regarding claim 13, as discussed above, Von Niessen teaches a core confectionary composition. Von Niessen teaches that the core confection contains preferably 0.1-44% of at least one additional component e) selected from the group including powdered milk (paragraphs 36 and 37). Thus, it would have been obvious suggestion of the prior art to use known powdered milks, including skim or whole milk powder. As evidenced by Think USA Dairy, dry whole milk or whole milk powder was known to typically contain 36.0-38.5% fat, 36.0-38.5% lactose, and 66-72% milk solids (protein, lactose and ash) (table, page 1). Thus, the addition of 0.1-44% milk solids as taught by Von Niessen would contribute 0.026-17.6% milk fat and 0.036-16.95% lactose to the core confectionary composition.
Regarding claim 20, as discussed above, Von Niessen teaches a core confectionary composition. Von Niessen teaches that the core confection contains: b) preferably 65-82% carbohydrates in the form of crystalline and non-crystalline carbohydrates; and preferably 0.1-44% of at least one additional component e) selected from the group including powdered milk (paragraphs 36 and 37). Thus, it would have been obvious suggestion of the prior art to use known powdered milks, including skim or whole milk powder. As evidenced by Think USA Dairy, dry whole milk or whole milk powder was known to typically contain 36.0-38.5% fat, 36.0-38.5% lactose, and 66-72% milk solids (protein, lactose and ash) (table, page 1). Thus, the addition of 0.1-44% milk solids as taught by Von Niessen would contribute 0.036-16.95% lactose, which is a carbohydrate, to the core confectionary composition, and the core composition would comprise a total of 65.036-98.95% total carbohydrates.
Regarding the claimed ranges, Von Niessen discloses overlapping ranges. 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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 7, 9, 12, 16-19, and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 15 of copending Application No. 18/260,264 (‘264) (reference application) as amended October 7, 2025.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim a confectionary comprising overlapping ranges of components, including: 10.0-30.0% water; 20% to less than 25% sucrose, 20.0-35.0% a combination of at least two of dextrose (D-glucose), fructose, maltose, and maltotriose; and 18.0-35.0% milk solids; 1.5-4.5% galactose (claim 15).
Regarding claims 16-19 and the composition as comprising 10.0-25.0% dextrose, 5.0-25.0% fructose, 0.02-2.5% maltose, or 0.02-2.5% maltotriose respectively, although ‘264 does not specifically recite the ranges in combination with the 1.5-4.5% galactose (claim 15), as ‘264 does recite 14.0-35.0% of at least two dextrose, fructose, maltose, and maltotriose, the claims of ‘264 encompass each of said components from 0% up to less than 35% which overlaps and encompasses the instantly claimed ranges.
Regarding 45.0-65.0% non-milk based carbohydrate as recited in claim 21, as ’264 recites a composition comprising 20.0-35.0% sucrose, and 14.0-35.0% additional non-milk carbohydrates (claim 1), the claims of ‘264 encompass a composition comprising 34.0-70% non-milk based carbohydrates.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 13 and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 15 of copending Application No. 18/260,264 (‘264) (reference application) as amended October 7, 2025, further as evidenced by Think USA Dairy (https://www.thinkusadairy.org/products/milk-powders/milk-powder-categories/dry-whole-milk-and-whole-milk-powder pages 1-2).
As discussed above, although the claims at issue are not identical, they are not patentably distinct from each other because both claim a confectionary comprising overlapping ranges of components, including: 10.0-30.0% water; 20% to less than 25% sucrose, 20.0-35.0% a combination of at least two of dextrose (D-glucose), fructose, maltose, and maltotriose; and 18.0-35.0% milk solids; 1.5-4.5% galactose (claim 15). As ’264 recites a composition comprising 20.0-35.0% sucrose, and 14.0-35.0% additional non-milk carbohydrates (claim 1), the claims of ‘264 encompass a composition comprising 34.0-70% non-milk-based carbohydrates.
‘264 does not specifically claim the composition as comprising 7.0-15.0% milk fat and 1.5-7.0% lactose as recited in claim 13, or the total carbohydrate content as between 50.0-70.0 as recited in claim 20.
Regarding the composition as comprising 7.0-15.0% milk fat and 1.5-7.0% lactose as recited in claim 13, ‘264 claims the composition as comprising 18.0-35.0% milk solids. The examiner takes official notice that milk solid ingredient components were known to encompass powdered milks. Thus, it would have been obvious suggestion of the claims of ‘264 to use known powdered milks, including skim or whole milk powder. As evidenced by Think USA Dairy, dry whole milk or whole milk powder was known to typically contain 36.0-38.5% fat and 36.0-38.5% lactose (table, page 1). Thus, the addition of 18.0-35.0% milk solids as claimed by ‘264 would contribute about 6.5-13.5% milk fat and about 6.5-13.5% lactose, a milk carbohydrate, and the product of ‘264 would overlap the product as claimed.
Regarding claim 20, as discussed above, ‘264 claims a product comprising 34.0-70% non-milk-based carbohydrates and about 6.5-13.5% lactose which is a milk-based carbohydrate. Thus, the product claimed by ‘264 encompasses one with about 40.5-83.5% total carbohydrates.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 23 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 15 of copending Application No. 18/260,264 (‘264) (reference application) as amended October 7, 2025, further in view of Von Niessen (US 2012/0244258).
As discussed above, although the claims at issue are not identical, they are not patentably distinct from each other because both claim a confectionary comprising overlapping ranges of components, including: 10.0-30.0% water; 20% to less than 25% sucrose, 20.0-35.0% a combination of at least two of dextrose (D-glucose), fructose, maltose, and maltotriose; and 18.0-35.0% milk solids; 1.5-4.5% galactose (claim 15).
‘264 is silent to the composition of claim 15 as comprising 0.05-1.0% hydrocolloid as recited in claim 23.
Von Niessen teaches a nutritional core confection comprising: a) 0.5-10% protein which is preferably gelatin, i.e. a stabilizer and hydrocolloid; b) 40-82%, preferably 65-82% carbohydrates in the form of crystalline and non-crystalline carbohydrates; and c) 10-30% water (abstract and paragraphs 8, 22, and 51). Von Niessen teaches that the gelatin is a preferred protein in the nutritional product (paragraphs 8, 51).
It would have been obvious for the confection claimed by ‘264 to comprise 0.5-10% gelatin, which is a hydrocolloid, for its nutritional benefits in view of Von Niessen.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed October 7, 2025 have been fully considered but they are not persuasive.
Applicant argues that Von Niessen teaches lactose and thus does not teach a composition comprising galactose as recited in amended claim 1 because lactose and galactose are different. This argument is not convincing to withdrawn the rejection. As stated previously and herein, lactose is composed of galactose, and thus, the lactose within the composition of Von Niessen would provide galactose to the final product. Additionally, the claims do not require the galactose be present outside of another component, such as in an isolated form as argued. The claim does not limit the form of the galactose, only that it be present in some manner within the composition. In fact, the instant disclosure exemplifies the galactose as added from milk powder, i.e. within another component and not added as an individual element (examples 1 and 2). This position is further supported as the disclosure also states that sources of sugar are used when making the product (see for example page 7 lines 19 and 38-40), and thus there is nothing to suggest that the recited sugars must be in an isolated form. Thus, the teachings of lactose, which contains galactose, in the broadest reasonable sense, is considered to encompass a product with galactose as stated above. Additional evidence from dictionary.com is provided herein showing that lactose comprises galactose.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). It is noted that the previous limitations of claim 15 were not considered in combination with the other dependent claims. Additionally, the previous rejection of independent claim 1 was withdrawn in light of the amendments.
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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KELLY BEKKER
Primary Patent Examiner
Art Unit 1792
/KELLY J BEKKER/Primary Patent Examiner, Art Unit 1792