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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/30/2025 has been entered.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10/30/2025 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. However, the non-patent literature publication titled, “13 Milk and Milk Products” is not legible and no concise explanation of relevance for the non-English information has been provided. According to 37 CFR 1.98 Content of information disclosure statement, it is required to submit a legible copy of each non-patent literature publication or that portion which caused it to be listed and to further include a concise explanation of relevance for non-English information. The information referred to in the non-patent literature document is not legible and no concise explanation of relevance for non-English information has been provided. Thus, the non-patent literature publication has not been considered.
Status of Claims
Claims 1-41 are pending in this application. Claims 1-16 and 41 are under examination. Claims 17-40 are withdrawn from consideration. Any objections or rejections not repeated below have been withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 3 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites, “wherein the casein protein is selected from the group consisting of alpha-caseins, beta-casein, and kappa caseins.” However, beta-casein is already required in the composition, as stated in claim 1. It is unclear if there is additional casein added to the composition. Is the Applicant wanting to further limit the type of casein, as these are already the types of casein that are naturally present in dairy milk? Does the Applicant mean to claim wherein the casein protein further comprises alpha-casein and kappa-casein? For the purpose of examination, as long as the prior art composition has alpha-casein, kappa-casein, and beta-casein, it will be considered to meet the claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 1-7 and 11-16 are rejected under 35 U.S.C. 103 as being unpatentable over Harju et al. US 20110097442 in view of Kanda et al. WO 2015037720.
Please note the rejection below is based off of paragraph numbers added to the English translation of Kanda et al. reference and supplied previously on 01/30/2024.
Regarding claims 1 and 7 Harju teaches a protein-containing beverage comprising water, as required by claim 1 [0013], [0056]. Harju discloses the beverage contains between 2.5 wt.% to 8wt.% protein based on the total weight of the protein-containing beverage [0019]. This is within the claimed range of 2 wt.% to 8 wt.% protein based on total weight of the beverage, as required by claim 1.
Harju discloses the protein component comprises undenatured whey protein, as required by claim 1, and excludes thermally denatured whey proteins, as required by claim 1 (the whey protein product is produced from fractions obtained by means of membrane filtration of raw milk and subjecting at least a portion to ultrafiltration to provide a whey protein concentrate; [0018], [0028], [0030]).
It is noted the process of producing protein fractions through filtration does not denature the whey protein but produces an undenatured whey protein [0007]. Additionally, the instant specification outlines the process of taking nonfat milk and subjecting it to one or more filtration steps to separate proteins [0046], where the filtration is able to separate the milk components without denaturing [0049-0050]. This is the same process used by Harju to take skim milk and subjecting it to filtration processes to produce the ideal whey and casein concentrate without the use of heat treatment ([0029], [0033], Example 1 [0042-0045], Claim 6). Therefore, Harju, which uses filtration techniques to produce protein fractions and does not denature the whey protein, but produces an undenatured whey protein ([0007], Example 1 [0042-0045]), is identical to the claimed whey protein ingredient and is considered to comprise greater than 70 wt.% undenatured whey protein, as required by claim 1, absent convincing arguments or evidence to the contrary. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (MPEP §2112.01 (I)).
Regarding the recitation in claim 1, wherein the whey protein ingredient includes at least 12 wt.% leucine based on total weight of the whey protein; Harju teaches the composition is an undenatured whey protein concentrate produced by means of filtration of raw milk [0028], [0030]. The Applicant’s specification states the protein ingredient may include native proteins, which are undenatured proteins, produced using filtration processes on milk [0041]. Both whey protein ingredients of Harju and the instant application are produced using filtration processes and are undenatured. Thus, the undenatured whey protein concentrate of Harju is identical to the claimed whey protein ingredient and is considered to include at least 12 wt.% leucine based on total weight of the whey protein, absent convincing arguments or evidence to the contrary.
As stated in In re Best, 562 F.2d 1252, 1255 (CCPA 1977): Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. [citation omitted] Whether the rejection is based on "inherency" under 35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products.
Harju teaches the protein-containing beverage comprises casein protein, as required by claim 1 [0015]. Harju does not specify the proportion of β-casein relative to a total amount of casein proteins is higher than a proportion of β-casein relative to a total amount of casein proteins in dairy milk, as required by claim 1. However, Harju does disclose the whey protein to casein protein weight ratio ranges from 50:50 to 90:10 and is preferably 80:20 whey protein to casein (Claim 1 and 2, [0015]). This is within the claimed range of whey protein to casein protein ratio ranging from 70:30 to 95:5, as required by claim 1; and within the claimed range of 75:25 to 95:5, as required by claim 7.
Kanda teaches a product having casein protein, that can be in the form of a protein containing beverage (a muscle synthesis promoter in liquid form; [0020]). The casein protein can come from purified casein products such as β-casein, α-caseins, or κ-caseins [0014], [0020]. Kanda teaches it is desirable to have casein protein in a protein product since casein protein is slowly and continuously metabolized when compared to whey protein [0003], allowing a longer release of protein.
Harju teaches the protein-containing beverage has a certain weight ratio range of casein (Claim 1 and 2, [0015]) and would allow any type of casein to be present in any amount within that wide range. Kanda teaches that casein protein can come from a purified source such as β-casein [0014], [0020]. Kanda discloses that casein is added to provide a protein product that allows a longer release of protein, since casein protein is slowly and continuously metabolized when compared to whey protein [0003]. Therefore, it would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Harju in view of Kanda to have added more casein to the formulation of Harju in order to improve the metabolization of the protein product taught by Harju. Also, it would have also been obvious for one of ordinary skill in the art to have selected any casein protein to add to the composition of Harju, including adding β-casein in a purified form, as taught by Kanda, within the claimed proportion of β-casein relative to a total amount of casein, as required by claim 1, since Kanda recognizes β-casein as one of the purified casein products that can be added [0014] allowing for slow and continuous metabolization when compared to whey protein [0003].
Regarding claim 2, Harju teaches the undenatured whey protein is 50% to 95%, preferably 75% to 85% of the protein [0019]. This is within the claimed range of 70% to 99.9% whey protein based on the weight of the protein.
Regarding claim 3, Harju does not state the casein protein is from either α-caseins, β-casein or κ-caseins. However, it is noted that these caseins all naturally occur in skim milk which is the preferred milk raw material for the protein product [0018].
Kanda teaches a product having casein protein, where the casein protein can come from purified casein products such as α-caseins, β-casein or κ-caseins [0014], [0020], and is desirable to have in a protein product since casein protein is slowly and continuously metabolized when compared to whey protein [0003], allowing a longer release of protein.
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Harju in view of Kanda to further incorporate the teachings of Kanda by having the casein protein be selected from the group consisting of α-caseins, β-casein or κ-caseins, since these casein proteins are slowly and continuously metabolized when compared to whey protein [0003].
Regarding claim 4, Harju discloses the casein protein remains in solution (the stability of the whey protein product is good with no settling [0017], meaning the casein within the whey protein product does not come out of solution and settle to the bottom of the beverage but remains in solution).
Regarding claim 5, Harju teaches the casein protein is 6% to 50% weight of the protein [0019]. This encompasses the claimed range of 0.1% to 30% casein based on the weight of the protein.
Regarding claim 6, Harju teaches the casein protein is 6% to 50% weight of the protein [0019]. This overlaps the claimed range of 5% to 13% casein based on the weight of the protein. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I)
Regarding claim 11, Harju teaches the beverage contains no glycomacropeptides (whey protein product does not have the release of glycomacropeptides within the product; [0017], [0036). It is noted glycomacropeptides are produced by enzymatically hydrolyzed casein proteins, as discussed in the specification of the instant application, [0011], and are present in conventional cheese making process, as stated by Harju [0017].
Regarding claim 12, Harju discloses the beverage is a lactose free product where the lactose content being at most 0.21% [0023]. This is within the claimed range of a lactose content of 1 wt.% or less.
Regarding claim 13, Harju teaches a product that does not contain food-grade acid or has 0 wt.% food-grade acid (Table 5 pg. 5 [0057]). This is within the claimed range of 2 wt.% or less of food-grade acid content.
Regarding claim 14, as noted above, Harju teaches the protein-containing beverage has a total protein content of between 2.5-8% by weight of the beverage, the protein is undenatured whey protein produced from fractions obtained by means of membrane filtration of raw milk and has a preferred whey to casein ratio of 80:20 [0015] [0018-0019], [0028] (Claims 1-2). The claimed protein-containing beverage as stated in claim 1, comprises a broader range of protein between 2-8 wt.%, comprises undenatured protein, and comprises a broader range of whey to casein ratio of between 70:30 to 95:5. Thus, the composition of Harju is identical to the composition in claim 1. Therefore, the identical composition of Harju is considered to possess the claimed property of a viscosity of 5 cP or less at room temperature, as required by claim 14 absent convincing arguments or evidence to the contrary. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977).
Regarding claim 15, Harju teaches the protein is derived from milk raw material by various membrane techniques and the preferred milk raw material is skim milk [0018]. Skim milk has not been subjected to the cheesemaking process. Therefore, the proteins derived from skim milk are proteins not derived from a cheesemaking process.
Regarding claim 16, Harju teaches the protein containing beverage further comprises at least one ingredient selected from the group consisting of a flavoring agent (the milk raw material may be supplemented with sugar fractions; [0018]). It is noted, adding sugar fractions to the milk raw material would change the sweetness profile of the overall end product, which is part of the flavor profile. Therefore, sugar fractions are considered a flavoring agent since the sweetness they impart influences the flavor.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Harju et al. US 20110097442 in view of Kanda et al. WO 2015037720 as applied to claim 1 above, and further in view of Bell US 20160073653.
Regarding claims 8 and 9, Harju teaches the protein-containing beverage includes minerals of milk origin ranging from 0.5% to 1.5% and the minerals can be supplemented, or added back into the product if lower than desired [0018], [0021]. Harju does not teach the specific amounts of sodium and potassium within the protein-containing beverage.
Bell teaches a protein containing beverage (nutritional beverage comprising whey; Abstract, [0034]). Bell discloses the beverage can contain between 30 mg to about 60 mg of sodium per 100 grams of nutritional beverage [0032], which is 0.03-0.06% sodium based on the total weight of the beverage. This is within the claimed range of less than 0.45 wt.% sodium based on the total weight of the beverage, as required by claim 8. Bell further discloses the beverage can contain between about 100 mg to 150 mg of potassium per 100 grams of beverage [0031], which is about 0.1-0.15% potassium based on the total weight of the beverage. This is within the claimed range of 0.02-3 wt.% potassium based on the total weight of the beverage, as required by claim 9.
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Harju in view of Kanda to incorporate the teachings of Bell by having the beverage contain sodium and potassium minerals within the range of Bell because athletes desire beverages that contain electrolytes and consuming potassium and sodium replaces the electrolytes loss from sweating [0037].
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Harju et al. US 20110097442 in view of Kanda et al. WO 2015037720 as applied to claim 1 above, and further in view of DeWille et al. US 6475539.
Regarding claim 10, Harju teaches the protein-containing beverage includes minerals of milk origin ranging from 0.5% to 1.5% and the minerals can be supplemented, or added back into the product if lower than desired [0018], [0021]. Harju does not teach the specific amount of calcium within the protein-containing beverage.
DeWille teaches a protein containing beverage (nutritional beverage comprising high levels of protein; C4 L58-61). DeWille discloses the beverage can contain 0.05-1.0% calcium by weight (C14 L50-55). This overlaps within the claimed range of 0.4-1.65 wt.% calcium based on the total weight of the beverage.
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Harju in view of Kanda to incorporate the teachings of DeWille by having the beverage contain calcium in the upper range of DeWille, in order to be meet calcium levels of 25-50% of the Recommended Daily Intake (RDI) for an average adult and delivering significant levels of bioavailable calcium in relatively little volume, as recognized by DeWille (C14 L55-57). DeWille notes that the amount of calcium can be adjusted according to the RDI desired, so if 75% RDI for calcium is desired it is within the purview of the artisan to obtain the recited value and adjust the amount of calcium within the beverage accordingly (C5 L27-40).
Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over Harju et al. US 20110097442 in view of Nair et al. US 20110159165.
Regarding claim 41 Harju teaches a protein-containing beverage comprising water [0013], [0056]. Harju discloses the beverage contains between 2.5 wt.% to 8wt.% protein based on the total weight of the beverage [0019]. This overlaps the claimed range or 2 wt.% to 5.5 wt.% protein based on total weight of the beverage. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Harju discloses the protein component comprises undenatured whey protein, (the whey protein product is produced from fractions obtained by means of membrane filtration of raw milk and subjecting at least a portion to ultrafiltration to provide a whey protein concentrate; [0018], [0028], [0030]).
It is noted the process of producing protein fractions through filtration does not denature the whey protein but produces an undenatured whey protein [0007]. Additionally, the instant specification outlines the process of taking nonfat milk and subjecting it to one or more filtration steps to separate proteins [0046], where the filtration is able to separate the milk components without denaturing [0049-0050]. This is the same process used by Harju to take skim milk and subjecting it to filtration processes to produce the ideal whey and casein concentrate without the use of heat treatment ([0029], [0033], Example 1 [0042-0045], Claim 6). Therefore, Harju which uses filtration techniques to produce protein fractions, which does not denature the whey protein, but produces an undenatured whey protein ([0007], Example 1 [0042-0045]), is identical to the claimed whey protein ingredient and is considered to comprise at least 50 wt.% undenatured whey protein, absent convincing arguments or evidence to the contrary. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (MPEP §2112.01 (I)).
Regarding the recitation, wherein the whey protein ingredient includes at least 12 wt.% leucine based on total weight of the whey protein; Harju teaches the composition is an undenatured whey protein concentrate produced by means of filtration of raw milk [0028], [0030]. The Applicant’s specification states the protein ingredient may include native proteins, which are undenatured proteins, produced using filtration processes on milk [0041]. Both whey protein ingredients of Harju and the instant application are produced using filtration processes and are undenatured. Thus, the undenatured whey protein concentrate of Harju is identical to the claimed whey protein ingredient and is considered to include at least 12 wt.% leucine based on total weight of the whey protein, absent convincing arguments or evidence to the contrary. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977).
Harju teaches the protein-containing beverage comprises casein protein. Harju discloses the whey protein to casein protein weight ratio ranges from 50:50 to 90:10, and is preferably 80:20 whey protein to casein (Claim 1 and 2, [0015]). This is within the claimed range of whey protein to casein protein ratio ranging from 70:30 to 95:5.
Harju teaches the protein product can be used in preparation of all kinds of product including acidified fresh products [0024] but does not teach a pH of 4.6 or less for the protein-containing beverage.
Nair teaches a protein product with whey and casein proteins in their undenatured protein micellar form [0008]. Nair teaches the protein-containing beverage (acidified milk drink) has a pH between 3.9 to 4.2 [0124-0125] and recognizes that in order to guarantee protein stabilization in the protein-containing beverage (acidified milk beverage) the pH must be between 3.5-4.5 [0008]. This is within the claimed pH range of 4.6 or less.
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Harju in view of Kanda to incorporate the teachings of Nair by having the protein-containing beverage have a pH within the claimed range, specifically a pH between 3.5-4.5, in order to guarantee protein stabilization in the protein-containing beverage, as recognized by Nair [0008].
Response to Arguments
Applicant’s arguments, see pg. 8, filed 10/30/2025, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of 35 U.S.C. 103 as being unpatentable over Harju et al. US 20110097442 in view of Kanda et al. WO 2015037720. This combination of references makes obvious the newly added limitation on the proportion of beta-casein in the beverage.
Applicant’s arguments with respect to claim(s) 41 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/S.R.G./Examiner, Art Unit 1791
/ELIZABETH GWARTNEY/Primary Examiner, Art Unit 1759