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
The status of the claims stands as follows:
Pending claims: 1-9, 13, 14, and 16-24
Canceled claims: 10-12, 15, and 25
Currently rejected claims: 1-9, 13, 14, and 16-24
Allowed claims: None
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.
Claims 3, 14, 15, and 19-22 are 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 3, 14, 15, and 19-22 recite numerous instances of a broad recitation of a range followed by one or more narrower ranges. The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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 1-9, 13, 14, and 16-24 are rejected under 35 U.S.C. 103 as being unpatentable over Tikanmaki et al. (U.S. 2014/0017332 A1) in view of Dunker et al. (U.S. 2004/0040448 A1).
Regarding claim 1, Tikanmaki et al. discloses a method for making a yogurt product ([0025]) having a weight ratio of whey protein to casein protein from 40:60 to 80:20 ([0015]), the method comprising:
ultrafiltering a milk product ([0031]-[0032]);
nanofiltering the UF permeate ([0040]);
diafiltering the UF retentate through a microfiltration membrane ([0041], where “a suitable fraction obtained from the membrane filtrations” is considered to implicitly disclose diafiltration of the UF retentate);
combining the NF retentate ([0042]), skim milk ([0040]), and a fat-rich fraction ([0023], [0042], [0035], where the casein-containing material may comprise full-fat milk or cream) to form a dairy composition; and
heat treating the composition ([0039]).
Tikanmaki et al. does not specifically disclose (i) the milk product subjected to ultrafiltration as having a whey protein to casein protein from 15:85 to 25:75; (ii) subjecting the NF retentate to reverse osmosis and incorporating the RO retentate into the combined dairy composition as one of the “at least three” ingredients; (iii) nanofiltering the MF/DF permeate to produce second NF permeate/retentate fractions; or (iv) inoculating the dairy composition with a yogurt culture and fermenting to produce the yogurt product.
Regarding the protein ratio in the starting material, Dunker et al. discloses that milk comprises 3% protein and 0.65% whey ([0004]), which indicates the ratio of whey to casein in milk falls within the claimed range of 15:85 and 25:75. Tikanmaki et al. discloses broadly that the whey protein product can be produced from a method utilizing “[t]wo or more techniques…including microfiltration, ultrafiltration, nanofiltration, and reverse osmosis” ([0029]). Although a preferred method involved performance of a microfiltration step on “a milk-based raw material” ([031]) that may be skim milk ([0049]), omission of the microfiltration in the performance of a method involving only two or three of the listed filtration steps would implicitly involve performance of the ultrafiltration step directly on the skim milk. For such an embodiment, the ultrafiltration step would be performed on a milk product having a whey protein to casein protein ratio in the range of from 15:85 to 25:75.
Regarding the step of subjecting the NF retentate to reverse osmosis, Tikanmaki et al. does disclose subjecting the NF permeate to reverse osmosis in order to concentrate the minerals ([0040], [0052]). The reference also indicates that the NF retentate comprises sugars ([0040]). Since reverse osmosis is discloses as simply concentrating components in a fraction, applying reverse osmosis to the NF retentate would be obvious in order to concentrate the sugars therein and minimize the volume of the component in the interest of optimizing costs related to handling and storing the component. Further, concentration of the NF retentate via the performance of reverse osmosis would result in an RO retentate comprising essentially the same components as the NF retentate. Adding such an RO retentate as an ingredient in place of an NF retentate would be obvious, since the same components would comprise both fractions, while simply being more concentrated in the RO retentate.
Regarding the step of nanofiltering a MF/DF permeate, the UF retentate would comprise primarily protein, as well as some lactose and ash (Tikanmaki et al., [0055], Table 1). Diafiltration is described only as “enhancing” the fractions ([0041]) but it is known in the art that diafiltration facilitates removal of certain relatively small compounds that are expelled through a filter while maintaining the concentration of larger compounds that are retained by the filter by replacing the solvent as it is passes through the filter. Diafiltration of the UF retentate would thus be expected to merely lower the lactose and ash concentrations, where such components would be expelled in the MF/DF permeate. Tikanmaki et al. indicates nanofiltration retains lactose and expels ash/minerals ([0040]). Performing a nanofiltration step on a MF/DF permeate would thus allow for harvesting additional sugars and minerals from the UF retentate, thus optimizing the efficiency of the separation methods. As such, performing a nanofiltration step on a MF/DF permeate would be obvious to a skilled practitioner.
Regarding the fermentation step, Dunker et al. discloses producing yogurt by inoculating a dairy composition with a yogurt culture and fermenting to produce a yogurt product ([0045]).
It would have been obvious to one having ordinary skill in the art to produce yogurt as disclosed in Tikanmaki et al. according to the conventional fermentation process taught in Dunker et al. Since Tikanmaki et al. indicates yogurt may be produced without specifying actual process steps ([0025]), a skilled practitioner would be motivated to consult Dunker et al. The instruction in Dunker et al. regarding the production of yogurt from a dairy composition renders the claimed step of inoculating the dairy composition with a yogurt culture and fermenting to produce a yogurt product obvious.
As for claim 2, Tikanmaki et al. discloses that diafiltering the UF retentate comprises diafiltering a mixture of the target fraction (e.g., the UF retentate fraction) and water and/or the NF permeate ([0041]).
As for claim 3, “the mixture” apparently refers to “a mixture of the UF retentate fraction and water/NF permeate fraction as claimed in claim 2, where the mixture is subject to diafiltration. However, diafiltration generally involves the addition and subsequent removal of the water/NF permeate fraction in order clarify/remove small compounds from the target fraction being treated. As such, adding any amount of water (and NF permeate fraction to the extent it would be available) would be obvious in order to simply achieve the desired degree of clarification, which renders essentially any solids content in the mixture of the target fraction and water obvious. The claimed solid content of from 5-20 wt.% would thus be obvious.
As for claim 4, Tikanmaki et al. discloses subjecting the NF permeate fraction to a reverse osmosis step to produce RO permeate/retentate fractions ([0040], [0052]).
As for claim 5, combining the RO permeate fraction (i.e., essentially water) with the other components of the mixed dairy composition would be obvious merely to adjust the solids content of the mixture.
Regarding claim 6, Tikanmaki et al. discloses a method for making a yogurt product ([0025]) having a weight ratio of whey protein to casein protein from 40:60 to 80:20 ([0015]), the method comprising:
ultrafiltering a milk product ([0031]-[0032]);
diafiltering the UF retentate through a microfiltration membrane ([0041], where “a suitable fraction obtained from the membrane filtrations” is considered to implicitly disclose diafiltration of the UF retentate);
nanofiltering the UF permeate ([0040]);
subjecting the NF permeate fraction to reverse osmosis ([0040], [0052]);
combining the NF retentate ([0042]), skim milk ([0040]), and a fat-rich fraction ([0023], [0042], [0035], where the casein-containing material may comprise full-fat milk or cream) to form a dairy composition; and
heat treating the composition ([0039]).
Tikanmaki et al. does not specifically disclose (i) the milk product subjected to ultrafiltration as having a whey protein to casein protein from 15:85 to 25:75; (ii) ultrafiltering the MF/DF permeate fraction (i.e., ultrafiltering after the diafiltration step); (iii) subjecting the NF retentate to reverse osmosis and incorporating the RO retentate into the combined dairy composition as one of the “at least three” ingredients; or (iv) inoculating the dairy composition with a yogurt culture and fermenting to produce the yogurt product.
Regarding the protein ratio in the starting material, Dunker et al. discloses that milk comprises 3% protein and 0.65% whey ([0004]), which indicates the ratio of whey to casein in milk falls within the claimed range of 15:85 and 25:75. Tikanmaki et al. discloses broadly that the whey protein product can be produced from a method utilizing “[t]wo or more techniques…including microfiltration, ultrafiltration, nanofiltration, and reverse osmosis” ([0029]). Although a preferred method involved performance of a microfiltration step on “a milk-based raw material” ([031]) that may be skim milk ([0049]), omission of the microfiltration in the performance of a method involving only two or three of the listed filtration steps would implicitly involve performance of the ultrafiltration step directly on the skim milk. For such an embodiment, the ultrafiltration step would be performed on a milk product having a whey protein to casein protein ratio in the range of from 15:85 to 25:75.
Regarding the step of ultrafiltering the MF/DF permeate fraction, MPEP 2144.04 VI B indicates that the duplication of parts is prima facie obvious absent a new/unexpected result. Repeating an ultrafiltration step in order to optimize the separation of components and resultant yield would be obvious, especially where the claim does not even require any subsequent utilization of the second UF permeate fraction or second UF retentate fraction.
Regarding the step of subjecting the NF retentate to reverse osmosis, Tikanmaki et al. does disclose subjecting the NF permeate to reverse osmosis in order to concentrate the minerals ([0040], [0052]). The reference also indicates that the NF retentate comprises sugars ([0040]). Since reverse osmosis is discloses as simply concentrating components in a fraction, applying reverse osmosis to the NF retentate would be obvious in order to concentrate the sugars therein and minimize the volume of the component in the interest of optimizing costs related to handling and storing the component. Further, concentration of the NF retentate via the performance of reverse osmosis would result in an RO retentate comprising essentially the same components as the NF retentate. Adding such an RO retentate as an ingredient in place of an NF retentate would be obvious, since the same components would comprise both fractions, while simply being more concentrated in the RO retentate.
Regarding the fermentation step, Dunker et al. discloses producing yogurt by inoculating a dairy composition with a yogurt culture and fermenting to produce a yogurt product ([0045]).
It would have been obvious to one having ordinary skill in the art to produce yogurt as disclosed in Tikanmaki et al. according to the conventional fermentation process taught in Dunker et al. Since Tikanmaki et al. indicates yogurt may be produced without specifying actual process steps ([0025]), a skilled practitioner would be motivated to consult Dunker et al. The instruction in Dunker et al. regarding the production of yogurt from a dairy composition renders the claimed step of inoculating the dairy composition with a yogurt culture and fermenting to produce a yogurt product obvious.
As for claim 7, Tikanmaki et al. discloses that diafiltering the UF retentate comprises diafiltering a mixture of the target fraction (e.g., the UF retentate fraction) and water ([0041]).
Regarding claim 8, Tikanmaki et al. discloses a method for making a yogurt product ([0025]) having a weight ratio of whey protein to casein protein from 40:60 to 80:20 ([0015]), the method comprising:
ultrafiltering a milk product ([0031]-[0032]);
diafiltering the UF retentate through a microfiltration membrane ([0041], where “a suitable fraction obtained from the membrane filtrations” is considered to implicitly disclose diafiltration of the UF retentate);
nanofiltering the UF permeate ([0040]);
subjecting the NF permeate fraction to reverse osmosis ([0040], [0052]);
combining the NF retentate ([0042]), skim milk ([0040]), and a fat-rich fraction ([0023], [0042], [0035], where the casein-containing material may comprise full-fat milk or cream) to form a dairy composition; and
heat treating the composition ([0039]).
Tikanmaki et al. does not specifically disclose (i) the milk product subjected to ultrafiltration as having a whey protein to casein protein from 15:85 to 25:75; (ii) ultrafiltering the MF/DF permeate fraction (i.e., ultrafiltering after the diafiltration step); (iii) nanofiltering the second UF retentate fraction; (iv) subjecting the NF retentate to reverse osmosis and incorporating the RO retentate into the combined dairy composition as one of the “at least three” ingredients; or (v) inoculating the dairy composition with a yogurt culture and fermenting to produce the yogurt product.
Regarding the protein ratio in the starting material, Dunker et al. discloses that milk comprises 3% protein and 0.65% whey ([0004]), which indicates the ratio of whey to casein in milk falls within the claimed range of 15:85 and 25:75. Tikanmaki et al. discloses broadly that the whey protein product can be produced from a method utilizing “[t]wo or more techniques…including microfiltration, ultrafiltration, nanofiltration, and reverse osmosis” ([0029]). Although a preferred method involved performance of a microfiltration step on “a milk-based raw material” ([031]) that may be skim milk ([0049]), omission of the microfiltration in the performance of a method involving only two or three of the listed filtration steps would implicitly involve performance of the ultrafiltration step directly on the skim milk. For such an embodiment, the ultrafiltration step would be performed on a milk product having a whey protein to casein protein ratio in the range of from 15:85 to 25:75.
Regarding the step of ultrafiltering the MF/DF permeate fraction, MPEP 2144.04 VI B indicates that the duplication of parts is prima facie obvious absent a new/unexpected result. Repeating an ultrafiltration step in order to optimize the separation of components and resultant yield would be obvious, especially where the claim does not even require any subsequent incorporation of the second UF permeate or second UF retentate fractions into the finished product.
Regarding the step of nanofiltering the second UF retentate fraction, there would not likely be any appreciable separation of performing nanofiltration on material that did not pass through an ultrafiltration membrane. All the material that remained in the retentate upon ultrafiltration would be expected to remain in the retentate upon nanofiltration as well. However, to the extent additional clarifying may be achieved via nanofiltration, such a step would be obvious in order to further refine the separation of materials.
Regarding the step of subjecting the NF retentate to reverse osmosis, Tikanmaki et al. does disclose subjecting the NF permeate to reverse osmosis in order to concentrate the minerals ([0040], [0052]). The reference also indicates that the NF retentate comprises sugars ([0040]). Since reverse osmosis is discloses as simply concentrating components in a fraction, applying reverse osmosis to the NF retentate would be obvious in order to concentrate the sugars therein and minimize the volume of the component in the interest of optimizing costs related to handling and storing the component. Further, concentration of the NF retentate via the performance of reverse osmosis would result in an RO retentate comprising essentially the same components as the NF retentate. Adding such an RO retentate as an ingredient in place of an NF retentate would be obvious, since the same components would comprise both fractions, while simply being more concentrated in the RO retentate.
Regarding the fermentation step, Dunker et al. discloses producing yogurt by inoculating a dairy composition with a yogurt culture and fermenting to produce a yogurt product ([0045]).
It would have been obvious to one having ordinary skill in the art to produce yogurt as disclosed in Tikanmaki et al. according to the conventional fermentation process taught in Dunker et al. Since Tikanmaki et al. indicates yogurt may be produced without specifying actual process steps ([0025]), a skilled practitioner would be motivated to consult Dunker et al. The instruction in Dunker et al. regarding the production of yogurt from a dairy composition renders the claimed step of inoculating the dairy composition with a yogurt culture and fermenting to produce a yogurt product obvious.
As for claim 9, Tikanmaki et al. discloses that diafiltering the UF retentate comprises diafiltering a mixture of the target fraction (e.g., the UF retentate fraction) and water ([0041]).
As for claim 13, Tikanmaki et al. discloses the milk product comprises skim milk ([0035], [0049]).
As for claim 14, Dunker et al. discloses that skim milk contains:
from 7-13 wt.% solids;
less than or equal to 0.5 wt.% fat;
from 2-5 wt.% protein;
from 3-6 wt.% lactose; and
from 0.4-1.2 wt.% minerals ([0054], Table 2, line 2).
As for claim 16, Dunker et al. discloses a fat-rich fraction that contains:
from 30-60 wt.% solids;
from 20-50 wt.% fat;
from 1-4 wt.% protein;
from 2-5 wt.% lactose; and
from 0.2-0.9 wt.% minerals ([0054], Table 2, line 3).
As for claim 17, Tikanmaki et al. discloses the heat treatment as comprising pasteurization at a temperature in the range of 63-75°C for a time ranging from 5 seconds to 45 minutes ([0044]).
As for claim 18, Dunker et al. discloses adding a flavorant ([0043]), a sweetener ([0047], or a vitamin/mineral ([0046]) to such a product when combining ingredients.
As for claim 19, Dunker et al. indicates the weight ratio of whey protein to casein protein in the milk product is in the range from 16:84 to 24:76 ([0004]).
As for claim 20, Tikanmaki et al. indicates the weight ratio of whey protein to casein protein in the yogurt product is in the range from 50:50 to 75:25 ([0015], where “about less than 50:50” is considered to touch the claimed range at 50:50).
As for claim 21, Dunker et al. discloses that whole milk and skim have component concentrations that overlap all of the claimed ranges ([0054], Table 2, lines 1-2). Tikanmaki et al. suggests generally that membrane filtration fractions may be combined to form the final products ([0040]). Recombining fractions to obtain component concentrations that are equivalent to those found in milk would at least be obvious, which renders the claimed ranges of from 8-15 wt.% solids, from 1-3 wt.% protein, from 0.05 to 4 wt.% fat, and from 0.1-1 wt.% minerals obvious.
As for claim 22, Tikanmaki et al. discloses the dairy composition contains 4-10 wt.% lactose ([0060], Table 3).
As for claim 23, Tikanmaki et al. discloses treating the dairy composition with lactase enzyme ([0046]).
As for claim 24, Dunker et al. disclose packaging the compositions into a container ([0051]).
Conclusion
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/JEFFREY P MORNHINWEG/Primary Examiner, Art Unit 1793