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 1-20 and 22 are pending and under examination in this application. Any objections or rejections not repeated below have been withdrawn.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.
Claim 22 is 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.
Claim 22 recites, “…processed in 20 hours in the liquid whey composition.” Upon further review of the specification, no recitation is found regarding processing time of 20 hours or any amount of processing time for the microfiltration process. Paragraphs [0026-0027] in the specification discuss the microfiltration system and the size of the microfilter membrane surface area but these paragraphs do not discuss the amount of time for processing. Therefore, the limitation is considered new matter as it is not disclosed in the specification.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-16 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Penttla et al. US 20120201839 (cited on IDS dated 01/29/2024).
Regarding claim 1, Penttla teaches a method of making an undenatured pre-acidified whey protein isolate (acidifying a soluble protein-containing component to produce a whey protein extract, where denaturation is optional; Abstract, [0042], [0148]).
Penttla teaches taking a liquid whey composition (whey protein-containing solution; [0047]) that has been subjected to various separation steps, separating the soluble whey protein from the insoluble whey protein. Penttla discloses acidifying the whey protein permeate (soluble whey protein; [0047-0050]). Penttla teaches reducing (acidifying) the pH of the whey protein permeate (soluble whey protein or solubilized protein-containing component) to a pH of at least about 2.5 [0115]. This overlaps the claimed pH of less than 3.8. 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).
Penttla teaches after reducing the pH of the whey protein permeate (whey protein extract comprising an acid treated aqueous soluble whey protein containing component; [0126]) further processes or modifications may be applied to the reduced pH whey protein permeate (whey protein extract), such as additional filtration methods using membrane filtration technology [0126-0134].
Penttla teaches different filtration methods can be applied throughout the process to selectively separate or concentrate the whey into larger and smaller molecules based on the pore sizes of the membranes used. Penttla states that ultrafiltration, microfiltration, nanofiltration and diafiltration are all membrane technologies that can be used in the process, among other filtration techniques [0135-0139]. However, Penttla is silent as to the specific membrane filtration sequence of ultrafiltration, microfiltration before pH reduction and then ultrafiltration, diafiltration and an optional nanofiltration after pH reduction.
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 Penttla by ultrafiltering a liquid whey composition, microfiltering the liquid whey protein retentate, and then after pH reduction to ultrafilter and diafilter the reduced pH whey protein and optionally nanofiltering because there is a prima facie case of obviousness for a change in sequence in the order of prior art process steps. See Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959). The selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results. See In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) and MPEP 2144.04(IV). Additionally, Penttla recognizes that these different filtration methods can be applied throughout the process to selectively separate or concentrate the whey into larger and smaller molecules based on the pore sizes of the membranes used [0135-0139].
Regarding claim 2, Penttla teaches spray drying the undenatured pre-acidified whey protein isolate, forming an undenatured pre-acidified whey protein isolate powder (the whey protein extract may be provided in a solid form by a suitable drying method, including spray drying; [0125]).
Regarding claim 3, modified Penttla teaches a microfiltered whey protein permeate, as discussed above in claim 1. Therefore, since the method of modified Penttla is a substantially identical process to the claimed process and forms a substantially identical microfiltered whey protein permeate to the claimed permeate, then the microfiltered whey protein permeate of modified Penttla is considered to possess the property of having a total solids content from 1.5 to about 3.5 wt.%, absent convincing arguments or evidence to the contrary. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (MPEP §2112.01 (I)).
Regarding claim 4, Penttla teaches different filtration methods can be applied throughout the process to selectively separate or concentrate the whey into larger and smaller molecules based on the pore sizes of the membranes used. Penttla states that membrane technologies that can be used in the process include reverse osmosis, as well as other membrane technologies [0135]. However, Penttla is silent as to the specific membrane filtration sequence of using reverse osmosis on the microfiltered whey protein permeate prior to reducing the pH.
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 Penttla by using reverse osmosis on the microfiltered whey protein permeate prior to reducing the pH because there is a prima facie case of obviousness for a change in sequence in the order of prior art process steps. See Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959). The selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results. See In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) and MPEP 2144.04(IV). Additionally, Penttla recognizes that these different filtration methods can be applied throughout the process to selectively separate or concentrate the whey into larger and smaller molecules based on the pore sizes of the membranes used [0135-0139].
Regarding claim 5, modified Penttla teaches a microfiltered whey protein permeate, as discussed above in claim 4. Therefore, since the method of modified Penttla is a substantially identical process to the claimed process and forms a substantially identical microfiltered whey protein permeate to the claimed permeate, then the microfiltered whey protein permeate of modified Penttla is considered to possess the property of having a total solids content of the protein permeate, after reverse osmosing, from about 3.5 to about 6 wt.%, absent convincing arguments or evidence to the contrary. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (MPEP §2112.01 (I)).
Regarding claim 6, Penttla teaches the liquid whey composition is obtained from a cheesemaking process (the whey protein-containing composition includes sweet whey, which is derived from the manufacture of cheeses; [0062-0063]).
Regarding claim 7, modified Penttla teaches the ultrafiltering of the liquid whey composition, as discussed above in claim 1. Penttla teaches diafiltration can be used with ultrafiltration but that ultrafiltration can be used on its own [0135], [0137]. Thus, modified Penttla teaches ultrafiltering of the liquid whey composition (whey protein-containing solution; [0047-0048]) does not include diafiltrating [0135], [0137].
Regarding claim 8, Penttla teaches reducing (acidifying) the pH of the microfiltered whey protein permeate (soluble whey protein or solubilized protein-containing component) to a pH of at least about 2.5 [0115]. This overlaps the claimed pH of less than or about 3.5. See MPEP 2144.05(I).
Regarding claim 9, modified Penttla teaches the reduced pH whey protein permeate, as discussed above in claim 1. While Penttla does not state that the acid used to reduce or acidify the whey protein permeate is a food-grade acidulant, the reference would have necessarily taught only using food-grade ingredients, including a food-grade acidulant, since the end product is a pre-acidified whey protein isolate (whey protein extract) that may be used in infant formula, as a dietary supplement or foodstuff (Abstract), all of which are food items requiring food-grade ingredients. See MPEP 2112. "In relying upon the theory of inherency, the examiner must provide a basis in fact and/or technical reasoning to reasonably support the determination that the allegedly inherent characteristic necessarily flows from the teachings of the applied prior art." Ex parte Levy, 17 USPQ2d 1461, 1464 (Bd. Pat. App. & Inter. 1990).
Regarding claims 10-16, modified Penttla teaches the undenatured pre-acidified whey protein isolate, as discussed above in claim 1. Therefore, since the method of modified Penttla is a substantially identical process to the claimed process and forms a substantially identical undenatured pre-acidified whey protein isolate to the claimed isolate, then the undenatured pre-acidified whey protein isolate of modified Penttla is considered to possess the following claimed properties of: greater than or about 18 wt.% solids, as required by claim 10; greater than or about 90 wt.% protein on a dry basis, as required by claim 11; a pH of less than or about 3.5, as required by claim 12; less than or about 5 wt.% ash, as required by claim 13; less than or about 2 wt.% minerals, as required by claim 14; from about 0.5 to about 2 wt.% lactose, as required by claim 15; and a turbidity of less than or about 10 NTU at a solids content of greater than or about 15 wt.%, as required by claim 16, absent convincing arguments or evidence to the contrary. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (MPEP §2112.01 (I)).
Regarding claim 18, Penttla teaches a method of making an acidified protein fortified beverage (an infant formula, follow on formula, dietary supplement or foodstuff that comprises the whey protein extract and is mixed with water; [0149], [0152]).
Penttla teaches taking a liquid whey composition (whey protein-containing solution; [0047]) that has been subjected to various separation steps, separating the soluble whey protein from the insoluble whey protein. Penttla discloses acidifying the whey protein permeate (soluble whey protein; [0047-0050]). Penttla teaches reducing (acidifying) the pH of the whey protein permeate (soluble whey protein or solubilized protein-containing component) to a pH of at least about 2.5 [0115]. This overlaps the claimed pH of less than 3.8. 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).
Penttla teaches after reducing the pH of the whey protein permeate (whey protein extract comprising an acid treated aqueous soluble whey protein containing component; [0126]) further processes or modifications may be applied to the reduced pH whey protein permeate (whey protein extract), such as additional filtration methods using membrane filtration technology [0126-0134].
Penttla teaches different filtration methods can be applied throughout the process to selectively separate or concentrate the whey into larger and smaller molecules based on the pore sizes of the membranes used. Penttla states that ultrafiltration, microfiltration, nanofiltration and diafiltration are all membrane technologies that can be used in the process, among other filtration techniques [0135-0139]. However, Penttla is silent as to the specific membrane filtration sequence of ultrafiltration, microfiltration before pH reduction and then ultrafiltration, diafiltration and an optional nanofiltration after pH reduction.
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 Penttla by ultrafiltering a liquid whey composition, microfiltering the liquid whey protein retentate, and then after pH reduction to ultrafilter and diafilter the reduced pH whey protein and optionally nanofiltering because there is a prima facie case of obviousness for a change in sequence in the order of prior art process steps. See Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959). The selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results. See In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) and MPEP 2144.04(IV). Additionally, Penttla recognizes that these different filtration methods can be applied throughout the process to selectively separate or concentrate the whey into larger and smaller molecules based on the pore sizes of the membranes used [0135-0139].
Regarding the limitation, “acidified protein fortified beverage” the specification states in paragraph [0063] that regardless of additional ingredients, an example of forming a protein fortified beverage is mixing water, or a pre-mixed beverage, with the undenatured pre-acidified whey protein isolate, which forms the protein fortified beverage. Thus, for the purpose of examination, “an acidified protein fortified beverage” will be viewed as mixing water, or a pre-mixed beverage, with the undenatured pre-acidified whey protein isolate, to form the acidified protein fortified beverage, no additional acid or a specific pH is required.
Penttla teaches mixing the undenatured pre-acidified whey protein isolate (blending the whey protein extract; [0152]) with a beverage (with water to form a liquid mixture; [0152]), to form the acidified protein fortified beverage.
Regarding claim 19, modified Penttla teaches the protein fortified beverage, as discussed above in claim 18. Therefore, since the method of modified Penttla is a substantially identical process to the claimed process and forms a substantially identical protein fortified beverage to the claimed beverage, then the protein fortified beverage of modified Penttla is considered to possess the property of and a turbidity of less than or about 30 NTU at a concentration of 5 wt.% protein in the protein fortified beverage, absent convincing arguments or evidence to the contrary. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (MPEP §2112.01 (I)).
Regarding claim 20, Penttla teaches spray drying the undenatured pre-acidified whey protein isolate (the whey protein extract may be provided in a solid form by a suitable drying method, including spray drying; [0125]) prior to mixing with the beverage (water may be mixed in to form a liquid mixture; [0152]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Penttla et al. US 20120201839 as applied to claim 1 above, and further in view of Holst et al. WO 2009112036 (cited on IDS dated 06/06/2023).
Regarding claim 17, Penttla teaches a protein fortified beverage (an infant formula, follow on formula, dietary supplement or foodstuff that comprises the whey protein extract; [0149], [0152]). Penttla discloses blending the undenatured pre-acidified whey protein isolate (whey protein extract) with water [0152]. Penttla does not disclose how much pre-acidified whey protein isolate should be in the protein fortified beverage but only states that it should be blended together in appropriate proportions with other ingredients that may be added [0152].
Holst teaches a protein fortified beverage (a whey protein beverage; Abstract, Claim 1, pg. 21 L18-21). Holst discloses the beverage comprises undenatured pre-acidified whey protein isolate (whey protein isolate manufactured by treating with an acidulant to adjust the pH value to below 3.8; pg. 20 L13-21) and water (pg. 23 L20-21). Holst states that whey protein isolate is a valuable source of nutrition for individuals with special nutritional needs, can be a valuable component of a diet program, and is a rich source of essential branched chain amino acids (pg. 1 L16-26). Holst teaches the beverage comprises from 0.5-15% by weight whey protein and a shielding agent, where the shielding agent is between 0.05% to 1% weight of the beverage and the whey protein would be between 0.45% to 14.95% by weight of the beverage (claims 1 and 7). This encompasses the claimed range from about 2 to about 10 wt.% whey protein isolate. See MPEP 2144.05(I).
It would have been obvious for a person of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Penttla to incorporate the teachings of Holst by having the beverage comprise the claimed amount of whey protein isolate because whey protein isolate is a valuable source of nutrition for individuals with special nutritional needs, can be a valuable component of a diet program, and is a rich source of essential branched chain amino acids, as recognized by Holst (pg. 1 L16-26).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Penttla et al. US 20120201839 as applied to claim 1 above, and further in view of Hurt et al. Factors that influence the membrane area of a multistage microfiltration process required to produce a micellar casein concentrate, Journal of Dairy Science 98:2222-2233, Year 2015. Hereinafter, Hurt.
Regarding claim 22, Penttla teaches the method of claim 1, as disclosed above. Penttla does not teach the microfilter has a total membrane surface area of less than or about 600 square meters per 1,000 pounds of protein processed in 20 hours in the liquid whey composition.
Hurt teaches a method to determine the minimum amount of membrane area needed to process a given mass of milk in a given time, specifically 150,000 kg of skim milk or it’s protein equivalent in 18 hours (pg. 2226 Materials and Methods, Minimization of MF Permeate paragraph 4, pg. 2226 Results and Discussion, Binding Constraints paragraph 1). Hurt teaches reducing the microfiltration membrane area by 36% by first ultrafiltering a liquid composition and then microfiltering the liquid retentate (feeding the microfiltration (MF) process with a diluted ultrafiltration retentate (DUR) diluted to the protein concentration of skim milk; Abstract). Hurt discloses the microfiltration (MF) membrane surface area required when feeding the microfiltration with an ultrafiltration retentate is 312 m2 for a 2-stage process (pg. 2228 Results and Discussion, UF of SM paragraph 1 and Figure 2) when processing 150,000 kg of skim milk or it's protein equivalent (having 3.2% protein, see Table 2) in 18 hrs, or in other words a microfilter having a total membrane surface area of 312 m2 per 10,580 pounds of protein processed in 18 hours in the liquid feed composition (a liquid feed with the protein composition of skim milk or DUR; pg. 2226 Materials and Methods, Minimization of MF Permeate paragraph 4, pg. 2226 Results and Discussion, Binding Constraints paragraph 1, pg. 2228 Results and Discussion, UF of SM paragraph 1 and Figure 2). This is within the claimed range of less than or about 600 m2 per 1,000 pounds of protein processed in 20 hours in the liquid whey composition.
While it is noted that the publication of Hurt was focused on micellar casein concentrate by processing the ultrafiltration retentate with microfiltration, the same principles would apply to using filtration to process a liquid whey protein retentate, namely that the microfiltration feed affects the membrane area, and when the feed for the microfiltration process has previously gone through an ultrafiltering process, then the membrane surface area for the microfilter can be reduced (pg. 2233 Conclusion).
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 Penttla to incorporate the teachings of Hurt by applying the same principles of reducing the membrane size surface area within the claimed range because ultrafiltering followed by microfiltration allows for the reduction of membrane surface area required, as recognized by Hurt (pg. 2222 Abstract and pg. 2233 Conclusion).
Therefore, when Penttla is modified by Hurt to have the microfilter membrane surface area within the claimed range, the microfiltering process steps of modified Penttla are substantially identical to the claimed method. Thus, modified Penttla would necessarily perform the claimed method of a microfilter having a total membrane surface area of less than or about 600 square meters per 1,000 pounds of protein processed in 20 hours in the liquid whey composition, absent convincing arguments or evidence to the contrary. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977), In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986), and MPEP §2112.02 (I).
Response to Declaration
The declaration under 37 CFR 1.132 filed 03/04/2026 is insufficient to overcome the rejection of claims 1-20 and 22 based upon the combination of references applied under 35 U.S.C 103 as set forth in the Office action.
Experimental evidence:
On pgs. 2-3 of the declaration, the Declarant discusses experimental evidence regarding total membrane size between processes that begin with an ultrafiltration step compared to beginning with a microfiltration step as in the prior art. Declarant states that when the convention sequence of microfiltration is followed by ultrafiltration a total of 286,480 square feet of membrane surface area is required but when ultrafiltration is followed by microfiltration than only 250,220 square feet of membrane surface area is needed to process the same amount of when in the same amount of time with the same percentage of total solids. Declarant discloses that this a 12.66% reduction in total membrane area. Declarant explains that unexpectedly, in addition to a reduced membrane surface area, the process of ultrafiltration followed by microfiltration, exhibited a reduction in time in addition to a reduction in total membrane surface area. Declarant explains the process allowed for an 11.38% reduction in processing time, to a processing time of 17.72 hours. Declarant states the order of process steps of the pending claims allow for improvement in both time and membrane surface area, and that the order of process steps are not trivial. However, the Office disagrees for the following reasons.
While the Office does agree that order of process steps reduces the needed membrane surface area for microfiltration and can reduce the processing time, this result is not unexpected. As shown by the rejection in claim 22, Hurt discusses the principle of how microfiltration feed affects the membrane surface area, and when the feed for the microfiltration process has previously gone through an ultrafiltering process, then the membrane surface area for the microfilter can be reduced and the filtration process can be completed in 18 hours (pg. 2226 Materials and Methods, Minimization of MF Permeate paragraph 4; pg. 2233 Conclusion).
Additionally, as shown by the rejection for claim 1 above, Penttla teaches different filtration methods can be applied throughout the process to selectively separate or concentrate the whey into larger and smaller molecules based on the pore sizes of the membranes used. Penttla states that ultrafiltration, microfiltration, nanofiltration and diafiltration are all membrane technologies that can be used in the process, among other filtration techniques [0135-0139]. While, Penttla is silent as to the specific membrane filtration sequence as claimed, 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 Penttla by ultrafiltering a liquid whey composition, microfiltering the liquid whey protein retentate, and then after pH reduction to ultrafilter and diafilter the reduced pH whey protein and optionally nanofiltering because there is a prima facie case of obviousness for a change in sequence in the order of prior art process steps. See Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959). The selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results. See In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) and MPEP 2144.04(IV). Additionally, Penttla recognizes that these different filtration methods can be applied throughout the process to selectively separate or concentrate the whey into larger and smaller molecules based on the pore sizes of the membranes used [0135-0139].
Turbidity:
On pgs. 3-4 of the declaration, the Declarant discusses the timing of acidification of the protein. Declarant states in prior art products, acidification was conducted after formation of the whey protein isolate, which would reduce the protein concentration level below the threshold for a whey protein isolate. Declarant notes that the claimed method employs an additional ultrafiltration operation after a microfiltering operation, which preserves the high protein content of the ultrafiltration retentate needed for whey protein isolate production. Declarant concludes that by using two ultrafiltration steps, separated by a microfiltration operation, both increased efficiency/reduced waste and provides excellent turbidity in the whey protein isolate. However, the Office disagrees for the following reasons.
The prior art of modified Penttla is a substantially identical process to the claimed process and forms a substantially identical protein fortified beverage to the claimed beverage. Therefore, the protein fortified beverage of modified Penttla is considered to possess the claimed beverage turbidity property, See In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (MPEP §2112.01 (I)).
As shown in the above rejection, Penttla teaches the liquid whey composition undergoes filtration steps, the pH is reduced, and then undergoes more filtration processes, finally producing a pre-acidified whey protein isolate. Specifically, Penttla teaches taking a liquid whey composition (whey protein-containing solution; [0047]) that has been subjected to various separation steps, separating the soluble whey protein from the insoluble whey protein. Penttla discloses acidifying the whey protein permeate (soluble whey protein; [0047-0050]). Penttla teaches reducing (acidifying) the pH of the whey protein permeate (soluble whey protein or solubilized protein-containing component) to a pH of at least about 2.5 [0115]. Penttla teaches after reducing the pH of the whey protein permeate (whey protein extract comprising an acid treated aqueous soluble whey protein containing component; [0126]) further processes or modifications may be applied to the reduced pH whey protein permeate (whey protein extract), such as additional filtration methods using membrane filtration technology [0126-0134]. Thus, the protein fortified beverage of modified Penttla is considered to possess the turbidity property as claimed, absent convincing arguments or evidence to the contrary. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (MPEP §2112.01 (I)).
Response to Arguments
Applicant's arguments filed March 4, 2026 have been fully considered but they are not persuasive.
Applicant argues, on pgs. 6-7 of their remarks, that the method steps are critical and have an unexpected technical effect. They state that a person of ordinary skill would have no motivation to arrive at each type of filtration, absent hindsight reliance upon the pending claims. They explain that prior art processes utilize a single ultrafiltration operation after an initial microfiltration operation. Applicant asserts the claimed process even though it has a higher number of steps has 12.66% reduction in membrane surface area and also an 11.38% reduction in processing time. Applicant contends the pending claims are not obvious over the cited art. However, the Office disagrees for the following reasons.
As shown by the rejection above, in relation to the unexpected results of a reduction in membrane surface area and processing time, Hurt discusses the principle of how microfiltration feed affects the membrane surface area. Hurt explains when the feed for the microfiltration process has previously gone through an ultrafiltering process, then the membrane surface area for the microfilter can be reduced and the filtration process can be completed in 18 hours (pg. 2226 Materials and Methods, Minimization of MF Permeate paragraph 4; pg. 2233 Conclusion). Thus, Penttla in view of Hurt teaches a reduced membrane surface area for microfiltering, as required by claim 22.
The method recited in claims 1 and 18 are rendered obvious by modified Penttla, as shown by the rejection above. Additionally, the membrane filtration technology outlined in Penttla is the same technology utilized in the instant specification. A person of ordinary skill in the art would be choosing from a finite number of identified, predictable solutions as to what combination of filtration method steps to apply before acidification of the whey and what filtration method steps to apply after acidification of the whey. Choosing from a finite number of identified, predictable solutions, with a reasonable expectation for success, is likely to be obvious to a person if ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S, 82 USPQ2d 1385, 1395 - 97 (2007) (see MPEP § 2143, E.).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant argues, on pg. 7 of their remarks, contends that the high solids content of claims 3 and 5 are due to the unique order of methods. They state how the method of Penttla would not arrive at the claimed method steps, so claims 3 and 5 are nonobvious over the cited art. However, the Office disagrees for the following reasons.
Modified Penttla teaches a substantially identical process to the claimed process and forms a substantially identical microfiltered whey protein permeate to the claimed permeate, then the microfiltered whey protein permeate of modified Penttla is considered to possess the property of having the claimed total solids content, absent convincing arguments or evidence to the contrary. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (MPEP §2112.01 (I)).
Applicant argues, on pgs. 7-8 of their remarks, that the beverage in claim 18 is an acidic beverage and that Penttla states the composition is neutralized prior to forming a beverage. However, the Office disagrees for the following reasons.
As stated in Penttla, paragraphs [0042-0050] describe the basic embodiments for forming the acidified protein. Penttla states in [0051] the above described methods may include an additional step of neutralizing the acidified soluble whey protein, but this is considered an optional step and is not required by Penttla.
Additionally, it is unclear what the pH of the acidic beverage would be as this is not disclosed in the specification. When you are neutralizing a base you are only reducing the acidic property of the composition but the composition can still be considered an acidic composition if the pH is below 7. If Penttla does have a neutralizing step, which is considered an optional step, Penttla states the final pH of the solubilized protein can still be below a pH of 7, at a pH of 6.5, and would still be considered acidic [0123].
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHANIE GERLA whose telephone number is (571)270-0904. The examiner can normally be reached Mon.-Wed. and Fri. 7-12 pm; Th. 7-2pm.
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/S.R.G./Examiner, Art Unit 1791
/ELIZABETH GWARTNEY/Primary Examiner, Art Unit 1759