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 .
Status of the Application
Receipt of the Response and Amendment after Non-Final Office Action filed 16 January 2026 is acknowledged.
Applicant has overcome the following by virtue of amendment of the claims: (1) the objections to the claims have been withdrawn; (2) the 112(b) rejection of claims 22-36 have been withdrawn.
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 22, 24-39
Withdrawn claims: 37-39
Previously canceled claims: 1-21
Newly canceled claims: 23
Amended claims: 37
New claims: None
Claims currently under consideration: 22 and 24-36
Currently rejected claims: 22 and 24-36
Allowed claims: None
Information Disclosure Statement
Receipt of the outstanding copy of WO 2020/159357 A1 in the information disclosure statement filed on 16 January 2026 is acknowledged. The information therein has been considered.
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 22 and 25-36 are rejected under 35 U.S.C. 103 as being unpatentable over Holst et al. (US 2019/0320672 A1, cited on the IDS filed on 24 April 2023) as evidenced by Vedantu (Calorific Value. (2020, August 4). Vedantu. Retrieved October 9, 2025, from https://web.archive.org/web/20200804175554/https://www.vedantu.com/biology/calorific-value).
Regarding claim 22, Holst teaches a nutritional composition comprising 3 to 7 g lipid/100 kcal, 1.25 to 5 g protein/100 kcal and 6 to 18 g digestible carbohydrate/100 kcal – Holst teaches a nutritional product, being an infant formula, comprising 35-70% (w/w TS) carbohydrate, 5-15% (w/w TS) protein, 20-40% (w/w TS) lipid (claim 20). As weight percentages of total solids, the disclosed percentages equate to g/100 g of the composition. As evidenced by Vedantu, the energy (kcal) in 1 g of these macronutrients is 4 kcal/g of carbohydrate, 4 kcal/g of protein, and 9 kcal/g of lipid (p. 2, Table). Therefore, 100 g of the disclosed composition with the lowest energy density contains 20 g lipid and 80 g total of protein and carbohydrate. The energy content in 100 g of this composition is:
(20 g lipid x 9 kcal/g lipid) + (80 g protein plus carbohydrate x 4 kcal/g protein plus carbohydrate) = 180 kcal lipid + 320 kcal protein plus carbohydrate = 500 kcal in 100 g
The content of macronutrients defined as g/100 kcal in a composition comprising 20 g lipid, 10-15 g protein and 65-70 g carbohydrate (to add up to the 100 g composition) is:
Lipid: (20 g lipid/500 kcal) x 100 = 4 g lipid/100 kcal
Protein: (10-15 g protein/500 kcal) x 100 = 2-3 g protein/100 kcal
Carbohydrate: (65-70 g carbohydrate/500 kcal) x 100 = 13-14 g carbohydrate/100 kcal
Holst teaches that, “While other carbohydrates may be added to the milk feed, it is preferred that the carbohydrate of the milk feed comprises at least 95% milk saccharide, and even more preferred essentially consists of milk saccharide” ([0081]), and “…even more preferably at least 95% (w/w) digestible milk saccharide relative to the total amount of carbohydrate” ([0386]). Therefore, up to 100% of the carbohydrate may be digestible milk saccharide. The disclosed values lie inside the claimed ranges of 3 to 7 g lipid/100 kcal, 1.25 to 5 g protein/100 kcal and 6 to 18 g digestible carbohydrate/100 kcal.
wherein the protein fraction comprises a native whey protein composition comprising whey protein and beta-casein, and is substantially devoid of alpha-casein and kappa-casein – Holst teaches that the nutritional composition further comprises 30-70% (w/w) whey protein relative to total protein, and 30-70% (w/w) casein relative to total protein (claim 20), and wherein at least 90% (w/w) (i.e., 90-100%) of the casein is beta-casein (claim 21). A nutritional composition comprising 70% of the total protein as whey protein and 30% of the total protein as casein, where 90% of the casein is beta-casein, contains 30% casein x 90% = 27% of the total protein as beta-casein. This means that the protein fraction of the nutritional composition contains 70% whey protein, 27% beta-casein, and 3% casein other than beta-casein. The range of “at least 90% (w/w) of the casein is beta-casein” as disclosed by Holst includes an embodiment wherein 100% of the casein is beta-casein, and therefore no casein other than beta-casein. As such, Holst discloses a range of casein other than beta-casein of 0-3%. As provided by the instant specification at paragraph [0024], “The native whey protein composition according to the invention is substantially devoid of alpha-casein and kappa-casein, preferably comprising less than 6 wt.% of the sum of alpha-casein and kappa-casein”. Therefore, where Holst teaches that the casein that is not beta-casein is as much as 3 wt%, the sum amount of alpha-casein and kappa-casein is 3% or less. In other words, Holst teaches that the protein fraction of the nutritional composition is substantially devoid of alpha-casein and kappa-casein as claimed.
wherein the ratio of whey protein to beta-casein is in the range between 85:15 and 55:45 – Holst teaches that the nutritional composition further comprises 30-70% (w/w) whey protein relative to total protein, and 30-70% (w/w) casein relative to total protein (claim 20), and wherein at least 90% (w/w) (i.e., 90-100%) of the casein is beta-casein (claim 21). Therefore, Holst teaches a ratio of whey protein to beta-casein from 70:30 to 30:70. The claimed range overlap the disclosed range. In a 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).
wherein the protein fraction has been pasteurized – Holst teaches that the nutritional product, thereby also the protein fraction of the nutritional product, may be pasteurized having an F0 value equivalent to at least 72 degrees C for 15 seconds ([0274]). Holst also teaches that the milk source/milk feed is pasteurized at 73 degrees C for 15 sec ([0470], [0477], [0486], [0497]). The protein fraction is obtained from the milk source/milk feed, and as such, is pasteurized. Holst further teaches that the microfiltration permeate ([0140]) and/or nanofiltration retentate ([0177]) may be subjected to pasteurization. Holst teaches that beta-casein and milk serum proteins (i.e., whey proteins) are in these fractions ([0122], [0133], [0135]).
and wherein the whey protein has a nativity of more than 80% – Holst teaches that in preferred embodiments, the milk serum protein (i.e., whey protein) of the milk feed is present in undenatured, native form, i.e., the same form as in raw milk, which has not been subjected to denaturing heat treatment, and that the milk feed has not been subjected to conditions resulting in significant protein denaturation, such as high temperature for prolonged durations ([0087]). Holst defines significant protein denaturation as when the degree of denaturation of beta-lactoglobulin (a whey protein) is at least 10% (w/w) ([0087]). It is noted that the pasteurization conditions disclosed by Holst (73 degrees C, 15 sec) are mild temperature, short time. Therefore, Holst teaches that the whey protein should be at least 90% in the native form.
wherein the nutritional composition comprises less than 2 wt% of the sum of alpha-casein and kappa-casein, based on the total protein weight of the protein fraction – As described above, Holst discloses a range of casein other than beta-casein of 0-3%, based on the total protein weight of the protein fraction. This range includes any alpha-casein and kappa-casein. The claimed range of less than 2 wt% overlaps the disclosed range of 0-3 wt% (less than 3 wt%). In a 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).
Holst does not teach that the nutritional composition comprises added free amino acids. However, this limitation is optional, and is therefore not required in the claimed invention.
Therefore, claim 22 is rendered obvious.
Regarding claim 25, Holst teaches the nutritional composition according to claim 22.
Holst also teaches that the ratio of whey protein to beta-casein is in the range between 80:20 and 60:40 – Holst teaches that the nutritional composition further comprises 30-70% (w/w) whey protein relative to total protein, and 30-70% (w/w) casein relative to total protein (claim 20), and wherein at least 90% (w/w) (i.e., 90-100%) of the casein is beta-casein (claim 21). Therefore, Holst teaches a ratio of whey protein to beta-casein from 70:30 to 30:70. The claimed range overlaps the disclosed range. In a 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).
Claim 25 is therefore rendered obvious.
Regarding claim 26, Holst teaches the nutritional composition according to claim 22.
Holst also teaches that the whey protein has a nativity of more than 90% – Holst teaches that in preferred embodiments, the milk serum protein (i.e., whey protein) of the milk feed is present in undenatured, native form, i.e., the same form as in raw milk, which has not been subjected to denaturing heat treatment, and that the milk feed has not been subjected to conditions resulting in significant protein denaturation, such as high temperature for prolonged durations ([0087]). Holst defines significant protein denaturation as when the degree of denaturation of beta-lactoglobulin (a whey protein) is at least 10% (w/w) ([0087]). It is noted that the pasteurization conditions disclosed by Holst (73 degrees C, 15 sec) are mild temperature, short time. Therefore, Holst teaches that the whey protein should be at least 90% in the native form.
Claim 26 is therefore rendered obvious.
Regarding claim 27, Holst teaches the nutritional composition according to claim 22.
Holst also teaches that the nutritional composition is selected from a preterm formula, an infant formula and a follow-on formula – Holst teaches that the nutritional composition is an infant formula (claim 20).
Furthermore, it is noted that the clause, “wherein the nutritional composition is selected from a preterm formula, an infant formula, and a follow-on formula” is a directed toward an intended use of the nutritional composition. A statement with regard to intended use is not further limiting insofar as the structure of the product is concerned. In order to patentably distinguish the claimed invention from the prior art, a claimed intended use must result in a structural difference between the claimed invention and the prior art. See MPEP §§ 2111.02(II) and 2111.04(I). In the present case there is no structural difference between the nutritional composition suggested in the prior art and the claimed nutritional composition. The clause is therefore not limiting.
Therefore claim 27 is rendered obvious.
Regarding claim 28, Holst teaches the nutritional composition according to claim 22.
Holst does not explicitly teach that the native whey protein composition has a protein solubility of more than 55% based on the total amount of protein in the native whey protein composition at acidic pH conditions.
However, Holst teaches that the protein fraction comprises 70% whey protein (claim 20) and that the denaturation of proteins from the milk feed should be less than 10% (i.e., is at least 90% native) ([0087]). Holst further teaches that the milk feed is not subjected to conditions resulting in significant protein denaturation, such as high temperature for prolonged durations ([0087]), but that the milk source/milk feed is pasteurized at 73 degrees C for 15 sec ([0470], [0477], [0486], [0497]), which is a mild temperature and short time. As evidenced by the instant specification at paragraph [0111], “all milk proteins except native whey proteins precipitate at pH 4.6” (i.e., acidic pH). Since Holst discloses a nutritional composition comprising 70% whey protein with at least 90% nativity (i.e., at least 63% native whey protein), it follows that the native whey protein composition of Holst has a protein solubility of at least 63% (i.e., more than 55%) based on the total amount of protein in the native whey protein composition at acidic pH conditions, as claimed.
Claim 28 is therefore rendered obvious.
Regarding claim 29, Holst teaches the nutritional composition according to claim 22.
Holst also teaches that the native whey does not originate from acid whey or from sweet whey – Holst teaches that the milk feed comprises, or even consists of, whole milk, skim milk, fat-free milk, low fat milk, full fat milk, or concentrated milk (claim 4), none of which is acid whey or sweet whey.
Additionally, it is noted that the limitation, “wherein the native whey does not originate from acid whey or from sweet whey” is a product-by-source limitation. Such limitations are unpatentable if the structure of the claimed product is identical to or obvious from a product of the prior art, even if the source or origin of the elements is different. Since Holst teaches a nutritional composition comprising all elements of claim 22, including native whey proteins, the native whey in the product disclosed by the prior art is patentably indistinguishable from the whey proteins in the nutritional composition as claimed.
Claim 29 is therefore rendered obvious.
Regarding claim 30, Holst teaches the nutritional composition according to claim 22.
Holst also teaches that the native whey protein composition is obtainable by cold membrane-filtration based technology – Holst also teaches that the temperature of the milk feed during the microfiltration of microfiltration/diafiltration may be in the range of 5-10 degrees C ([0121]). Holst further teaches that beta casein dissociates from the casein micelles at low temperature, and when cooled milk feed is fractionated by microfiltration or microfiltration/diafiltration at low temperature, the dissociated beta-casein is transferred to the microfiltration permeate ([0122]). Milk serum proteins (i.e., whey proteins), lactose, and minerals are also enriched in the microfiltration permeate ([0111]). Therefore, Holst teaches that the native whey protein composition (whey protein and beta-casein) is obtainable by cold membrane filtration.
Furthermore, it is noted that the clause, “wherein the native whey protein composition is obtainable by cold membrane-filtration based technology” is a product-by-process limitation.
MPEP § 2113(I) states, “Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. ‘[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.’ In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).”, and “The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979).”
MPEP § 2113(III) states, “The use of 35 U.S.C. §§ 102 and 103 rejections for product-by-process claims has been approved by the courts. ‘[T]he lack of physical description in a product-by-process claim makes determination of the patentability of the claim more difficult, since in spite of the fact that the claim may recite only process limitations, it is the patentability of the product claimed and not of the recited process steps which must be established. We are therefore of the opinion that when the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable. As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith. In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).’”.
In the present case, since Holst teaches a nutritional composition comprising all elements of claim 22, including the native whey protein composition as claimed, the product disclosed by the prior art is patentably indistinguishable from the claimed nutritional composition.
Therefore claim 30 is rendered obvious.
Regarding claim 31, Holst teaches the nutritional composition according to claim 22.
Holst also teaches that the native whey protein composition has been pasteurized at 72 - 74 °C for 15 to 30 seconds – Holst teaches that the nutritional product, thereby also the native whey protein composition of the nutritional product, may be pasteurized having an F0 value equivalent to at least 72 degrees C for 15 seconds ([0274]). Holst also teaches that the milk source/milk feed is pasteurized at 73 degrees C for 15 sec ([0470], [0477], [0486], [0497]). The native whey protein composition is obtained from the milk source/milk feed, and as such, is pasteurized. Holst further teaches that the microfiltration permeate ([0140]) and/or nanofiltration retentate ([0177]) may be subjected to pasteurization. Holst teaches that beta-casein and milk serum proteins (i.e., the native whey protein composition) are in these fractions ([0122], [0133], [0135]).
Claim 31 is therefore rendered obvious.
Regarding claim 32, Holst teaches the nutritional composition according to claim 22.
Holst does not explicitly teach that the nutritional composition exhibits an alkaline phosphatase activity of at most 350 mU/L.
However, Holst teaches that the nutritional product may be pasteurized having an F0 value equivalent to at least 72 degrees C for 15 seconds ([0274]). Holst also teaches that the milk source/milk feed is pasteurized at 73 degrees C for 15 sec ([0470], [0477], [0486], [0497]). As evidenced by the instant specification at paragraph [0020], “Pasteurized compositions are substantially free of alkaline phosphatase activity…the term substantially free of alkaline phosphatase activity means that …the alkaline phosphatase activity is below 350 mU/L”. Since Holst discloses a nutritional composition that has been pasteurized, it necessarily follows that the nutritional composition would exhibit an alkaline phosphatase activity of at most 350 mU/L as claimed.
Claim 32 is therefore rendered obvious.
Regarding claim 33, Holst teaches the nutritional composition according to claim 22, wherein the native whey protein composition and optionally at most 2 wt% of added free amino acids based on the total weight of protein in the nutritional composition are the sole protein sources for the nutritional composition – Holst teaches that the nutritional composition further comprises 30-70% (w/w) whey protein relative to total protein, and 30-70% (w/w) casein relative to total protein (claim 20), and wherein at least 90% (w/w) of the casein is beta-casein (claim 21). Holst therefore discloses an embodiment comprising 70% whey protein and 30% beta-casein, since “at least 90% (w/w) of the casein is beta-casein” includes an embodiment wherein 100% of the casein is beta-casein.
The claimed amino acids are optional, and therefore not required.
Claim 33 is therefore rendered obvious.
Regarding claims 34-36, Holst teaches the nutritional composition according to claim 22.
The limitations of claims 34-36 are product-by-process limitations.
MPEP § 2113(I) states, “Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. ‘[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.’ In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).”, and “The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979).”
MPEP § 2113(III) states, “The use of 35 U.S.C. §§ 102 and 103 rejections for product-by-process claims has been approved by the courts. ‘[T]he lack of physical description in a product-by-process claim makes determination of the patentability of the claim more difficult, since in spite of the fact that the claim may recite only process limitations, it is the patentability of the product claimed and not of the recited process steps which must be established. We are therefore of the opinion that when the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable. As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith. In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).’”.
In the present case, since Holst teaches a nutritional composition comprising all elements of claim 22, the product disclosed by the prior art is patentably indistinguishable from the claimed nutritional composition.
Therefore, claims 34-36 are rendered obvious.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Holst et al. as applied to claim 22 above, and further in view of Lien (Lien, E.L. (2003). Infant formulas with increased concentrations of alpha-lactalbumin. Am J Clin Nutr, 77(6), 1555S-8S.).
Regarding claim 24, Holst teaches the nutritional composition according to claim 22.
Holst does not teach that the ratio beta-lactoglobulin to alpha-lactalbumin is below 7:3.
However, Lien teaches that human milk contains a much larger proportion of alpha-lactalbumin than does bovine milk or whey-dominant formula, and that beta-lactoglobulin is not found in human milk (p. 1555S, col. 2, ¶ 2; p. 1556S, Figure 1). Lien also teaches that it is desired to improve the quality of infant formula to make it more like human milk (p. 1555S, col. 1, ¶ 2). Lien teaches an alpha-lactalbumin-enriched formula, wherein alpha-lactalbumin is present in a greater quantity than beta-lactoglobulin (p. 1556S, Figure 1; p. 1557S, col. 1, ¶ 3 – col. 2, ¶ 1).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the nutritional composition of Holst with the teachings of Lien to provide a nutritional composition comprising a greater quantity of alpha-lactalbumin than beta-lactoglobulin (i.e., wherein the ratio of beta-lactoglobulin to alpha-lactalbumin is below 7:3). One of ordinary skill in the art would have been motivated to do so in order to produce a formula more similar to human milk. One of ordinary skill in the art would have had a reasonable expectation of success in doing so because Lien teaches an alpha-lactalbumin-enriched formula that more closely resembles human milk (p. 1556S, Figure 1), and that feeding such a composition to infants results in normal growth (p. 1557S, col. 2, ¶ 1).
Claim 24 is therefore rendered obvious.
Response to Arguments
Claim Rejections – 35 U.S.C. § 103: Applicant’s arguments filed on 16 January 2026 have been fully considered, but they are not persuasive.
Applicant first argued that the inventors found that the protein composition as claimed comprising native whey subjected to mild heat treatment significantly improved GI tolerance (improved gastric emptying, increased the rate of gastric emptying, and reduced the rate and extent of gastric coagulation) in a preclinical piglet model, referencing Examples 5, 6, and 9 of the instant specification. (p. 7, ¶¶ 1-4). Applicant argued that the protein composition as claimed is ideally suited to be incorporated into infant formulas because the positive effects of native whey proteins are preserved when casein is beta-casein and when the composition is substantially devoid of alpha- and kappa-casein (pp. 7-8, bridging ¶).
In response, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Holst renders the claimed composition obvious, as described in the rejection. Applicant’s argument is therefore not persuasive.
Applicant next argued that the claimed composition is not obvious over Holst because the document centers on improvements and simplifications of the production of the nutritional product rather than any health effects associated therewith or any medical indication connected to gastrointestinal intolerance (p. 8, ¶ 2).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., health effects and medical indications) are not recited in the rejected claim(s). 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). Moreover, the instant claims are toward a nutritional composition. Obtaining health effects or assigning medical indications of the composition are intended uses of the composition. A statement with regard to intended use is not further limiting insofar as the structure of the product is concerned. In order to patentably distinguish the claimed invention from the prior art, a claimed intended use must result in a structural difference between the claimed invention and the prior art. See MPEP § 2111.02(II). In the present case there is no difference between the composition suggested in the prior art and the claimed composition. Applicant’s argument is therefore not persuasive.
Applicant next argued that Holst does not teach or suggest a nutritional composition comprising a pasteurized and native whey protein composition with a nativity of above 80% and less than 2 wt% of the sum of alpha-casein and kappa-casein (p. 8, ¶ 2). Applicant argued that the claimed feature of the composition comprising less than 2 wt% of the sum of alpha-casein and kappa-casein based on total protein weight is not taught and cannot be inferred from the teachings of Holst (p. 8, ¶ 3). Applicant argued that the Examiner used an inherency argument that requires the claimed feature to be necessarily present in the prior art, not merely possibly or probably present, and that the Examiner has not provided evidence that practicing the prior art as taught would inevitably result in a composition according to claim 22 (Id.).
In response, and as described in the rejection of claim 22 hereinabove, Holst teaches that the nutritional composition further comprises 30-70% (w/w) whey protein relative to total protein, and 30-70% (w/w) casein relative to total protein (claim 20), and wherein at least 90% (w/w) (i.e., 90-100%) of the casein is beta-casein (claim 21). These are claimed embodiments of the nutritional product of Holst. A nutritional composition comprising 70% of the total protein as whey protein and 30% of the total protein as casein, where 90% of the casein is beta-casein, contains 30% casein x 90% = 27% of the total protein as beta-casein. This means that the protein fraction of the nutritional composition contains 70% whey protein, 27% beta-casein, and 3% casein other than beta-casein. The range of “at least 90% (w/w) of the casein is beta-casein” as disclosed by Holst includes an embodiment wherein 100% of the casein is beta-casein, and therefore no casein other than beta-casein. As such, Holst discloses a range of casein other than beta-casein of 0-3 wt%. This range includes any alpha-casein and kappa-casein. The claimed range of less than 2 wt% overlaps the disclosed range of 0-3 wt% (less than 3 wt%). In a 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). These calculations indicate that the claimed composition is obvious in view of Holst, even if Holst does not explicitly identify alpha-casein and kappa-casein. Where Holst discloses and claims an embodiment of the composition wherein 100% of the casein is beta-casein, it necessarily flows that no alpha-casein or kappa-casein is present in such an embodiment. Applicant’s argument is therefore not persuasive.
Applicant next argued that the claimed features of whey protein nativity of more than 80%, the protein composition comprising less than 2 wt% of the sum of alpha-casein and kappa-casein based on the total protein weight and the protein fraction being pasteurized are all required to obtain the beneficial results on gastrointestinal tolerance, and that these results are wholly unexpected based on the prior art (pp. 8-9, bridging ¶). Applicant argued that Holst is completely silent on any effect on gastrointestinal intolerance, and therefore nothing in Holst teaches that the feature of the composition being substantially devoid of alpha-casein and kappa-casein would be result effective, citing MPEP § 2144.05(III)(C) (pp. 8-9, bridging ¶).
In response, MPEP § 2144.05(III)(C) states, “Applicants may rebut a prima facie case of obviousness based on optimization of a variable disclosed in a range in the prior art by showing that the claimed variable was not recognized in the prior art to be a result-effective variable.” Optimization of a variable disclosed in the range in the prior art is not at hand. Holst teaches and claims embodiments of the composition comprising less than 2 wt% of the sum of alpha-casein and kappa-casein, based on the total weight of the protein fraction as explained above. As described in the rejection of claim 22, Holst also teaches that the whey protein should be at least 90% in the native form and that the protein fraction is pasteurized. Applicant’s argument is therefore not persuasive.
Applicant’s assertion of unexpected technical results (p. 8, ¶ 4 – p. 9, ¶ 2) is acknowledged. Applicant’s argument has been considered, but it is not found to be persuasive. MPEP § 2145 states, “If a prima facie case of obviousness is established, the burden shifts to the applicant to come forward with arguments and/or evidence to rebut the prima facie case. See, e.g., In re Dillon, 919 F.2d 688, 692, 16 USPQ2d 1897, 1901 (Fed. Cir. 1990) (en banc)”, and “[r]ebuttal evidence may include evidence of ‘secondary considerations,’ such as ‘commercial success, long felt but unsolved needs, [and] failure of others.’ Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 4459, 467. See also, e.g., In re Piasecki, 745 F.2d 1468, 1473, 223 USPQ 785, 788 (Fed. Cir. 1984) (commercial success). Rebuttal evidence may also include evidence that the claimed invention yields unexpectedly improved properties or properties not present in the prior art. Rebuttal evidence may consist of a showing that the claimed compound possesses unexpected properties. Dillon, 919 F.2d at 692-93, 16 USPQ2d at 1901. A showing of unexpected results must be based on evidence, not argument or speculation. In re Mayne, 104 F.3d 1339, 1343-44, 41 USPQ2d 1451, 1455-56 (Fed. Cir. 1997)”. However, as provided by MPEP § 2145(II), “[m]ere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979)”, and “‘[t]he fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.’ Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985)”. Furthermore, “[e]vidence of unexpected results must be weighed against evidence supporting prima facie obviousness in making a final determination of the obviousness of the claimed invention. In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978).” See MPEP § 716.02(c)(I). “‘Expected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof.; In re Gershon, 372 F.2d 535, 538, 152 USPQ 602, 604 (CCPA 1967)”. See MPEP § 716.02(c)(II).
“Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the ‘objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.’ In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980)”. See MPEP § 716.02(d).
In the present case, Applicant’s observations that the claimed composition results in beneficial results on gastrointestinal tolerance, and reduced coagulation in Examples 5, 6, and 9 are latent properties and advantages of the composition. Holst renders obvious the composition as claimed, including wherein at least 90% and up to 100% of the casein is beta-casein. “Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979)”, and “‘[t]he fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.’ Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985)”.
Additionally, Applicant’s evidence is not commensurate in scope with the claimed invention. There is no indication of the amount of alpha-casein and kappa-casein in the WPC-AB of Example 9 and no comparative example with the maximum claimed amount of the sum of alpha-casein and kappa-casein of 2 wt% to demonstrate that the alleged unexpected effects are still observed. Furthermore, the claimed ratio of whey protein to beta-casein of between 85:15 and 55:45 is broader than is supported by the examples, and the nativity of the whey protein in Example 5 is over 90%, and the claimed invention recites that the whey protein has a nativity of more than 80%. These examples of the evidence not being commensurate in scope with the claimed invention are not meant to be exhaustive. From the examples provided, it cannot be ascertained whether the alleged unexpected result occurs over the entire claimed ranges and combinations of the claimed ingredients, and none of the claims are directed toward the specific embodiment provided by any of the examples.
Applicant argued that the dependent claims are patentable over the cited references at least by virtue of their dependence from independent claim 22 (p. 9, ¶¶ 3-4).
Where claim 22 is not patentable, neither are the dependent claims.
For at least these reasons, the claims remain rejected under 35 U.S.C. § 103 as presented hereinabove.
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).
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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/JAMES P. SHELLHAMMER/Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793