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 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 Claims 17-40 are withdrawn from consideration. Any objections or rejections not repeated below have been withdrawn.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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-16 and 41 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 41 recite, “wherein the protein-containing beverage is transparent.” Upon further review of the specification, it is found that this limitation is never disclosed in the specification. The specification does not discuss the protein-containing beverage being transparent. The specification in paragraph [0051] does discuss the organoleptic qualities of the beverage, stating that the turbidity and transparency of the beverage are considered to be part of these qualities, and explaining that turbidity of the beverage indicates the degree of cloudiness (e.g., opacity). However, the disclosure does not positively state that the beverage is transparent, it does not discuss what the turbidity of the beverage is or state how transparent the beverage is, e.g. zero transparency (opaque) or 100% transparent (clear). Thus, the limitation of claims 1 and 41 are considered new matter since the limitation is not present in the disclosure.
Claims 2-16 are included in the rejection because they depend from a rejected base 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 and Sherwood et al. US 20110183052.
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].
Harju does not state that the protein containing beverage is transparent. Sherwood teaches a protein beverage that comprises protein isolate collected from membrane-filtration and may contain about 0.01-15% by weight protein and a balance of water (Abstract, [0004], [0041]). Sherwood teaches the protein-containing beverage is transparent (the protein beverage is transparent without turbidity and is clear in color; [0068], Claim 6). Sherwood discloses this results in a beverage with superior organoleptic properties [0055].
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 Sherwood by having a transparent beverage because this results in a beverage with superior organoleptic properties, as recognized by Sherwood [0055].
Regarding claim 2, modified Harju discloses the protein containing beverage of claim 1, as discussed above. 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, modified Harju discloses the protein containing beverage of claim 1, as discussed above. Harju does not state the casein protein is from either α-caseins 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 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 and Sherwood to further incorporate the teachings of Kanda by having the casein protein be selected from the group consisting of α-caseins or κ-caseins, since these casein proteins are slowly and continuously metabolized when compared to whey protein [0003].
Regarding claim 4, modified Harju discloses the protein containing beverage of claim 1, as discussed above. 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, modified Harju discloses the protein containing beverage of claim 1, as discussed above. 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, modified Harju discloses the protein containing beverage of claim 5, as discussed above. 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, modified Harju discloses the protein containing beverage of claim 1, as discussed above. 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, modified Harju discloses the protein containing beverage of claim 1, as discussed above. 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, modified Harju discloses the protein containing beverage of claim 1, as discussed above. 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, modified Harju discloses the protein containing beverage of claim 1. 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, modified Harju discloses the protein containing beverage of claim 1, as discussed above. 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, modified Harju discloses the protein containing beverage of claim 1, as discussed above. 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 and Sherwood et al., US 20110183052 as applied to claim 1 above, and further in view of Bell US 20160073653.
Regarding claims 8 and 9, modified Harju discloses the protein containing beverage of claim 1, as discussed above. 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 and Sherwood 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 and Sherwood et al., US 20110183052 as applied to claim 1 above, and further in view of DeWille et al. US 6475539.
Regarding claim 10, modified Harju discloses the protein containing beverage of claim 1, as discussed above. 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 and Sherwood 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 and Sherwood et al., US 20110183052.
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].
Harju does not state that the protein containing beverage is transparent. Sherwood teaches a protein beverage that comprises protein isolate collected from membrane-filtration, may contain about 0.01-15% by weight protein and a balance of water, and has a pH of between about 2 to about 4.6 (Abstract, [0004], [0041]). Sherwood teaches the protein-containing beverage is transparent (the protein beverage is transparent without turbidity and is clear in color; [0068], Claim 6). Sherwood discloses that a clear beverage that does not have protein precipitation results in a beverage with superior organoleptic properties [0055].
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 Sherwood by having a transparent beverage because this results in a beverage with superior organoleptic properties, as recognized by Sherwood [0055].
Response to Arguments
Applicant’s arguments regarding no motivation to modify Harju in view of Kanda with respect to claim(s) 1-16 and 41 have been considered but are moot because the new ground of rejection does not rely on any teaching or matter specifically challenged in the argument.
Additionally, applicant argues on pg. 9 of their remarks that to modify the beverage of Harju to be transparent would destroy the direction of Harju, since the product would no longer look like milk. Applicant also argues that Kanda is also directed to a milk drink and suffers from the same deficiencies as Harju. However, the Office disagrees for the following reasons.
Harju states in [0013] that in “an embodiment of the invention, it is possible to prepare a whey protein beverage that looks and tastes like milk.” However, this is one embodiment of the invention and does not encompass all of the types of whey protein beverages that can be made. Harju teaches in paragraph [0025] that the products of the invention can be nutritional products, food supplements, health food products, and pharmaceutical products, where the form of each of the food product is not particularly limited. Thus, the form of a health food product, like a protein beverage, does not need to be particularly limited to a beverage that looks and tastes like milk. Therefore, modifying the protein beverage of Harju does not destroy the direction of Harju, since only one specific embodiment of Harju requires that the product look and taste like milk, while other embodiments do not require this. A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989). See MPEP 2123.
Similarly, while Kanda does state in a preferred embodiment that their invention may be a milk drink [0032], this is just one embodiment and does not look at all the different embodiments and types of beverages taught Kanda. Kanda states that the present invention can be in the form of a food and drink [0021] and where the food and drink is something that is orally taken and is not particularly limited, giving specific examples of drinks like soft drinks, fruit juice drinks, etc., which are not a milk drink [0025]. See MPEP 2123. Thus, Harju in view of Kanda can be modified by Sherwood to be a protein containing beverage that is transparent, as shown by the rejection above.
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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/S.R.G./Examiner, Art Unit 1791
/ELIZABETH GWARTNEY/Primary Examiner, Art Unit 1759
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