DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
Receipt of the Response and Amendment after Non-Final Office Action filed 05/08/2026 is acknowledged.
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1-9 and 19-29
Withdrawn claims: None
Previously canceled claims: 10-18
Newly canceled claims: None
Amended claims: None
New claims: None
Claims currently under consideration: 1-9 and 19-29
Currently rejected claims: 1-9 and 19-29
Allowed claims: None
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 2, 4, 5, 7-9, and 19-29 are rejected under 35 U.S.C. 103 as being unpatentable over McCormick et al. (U.S. 2020/0120947 A1) in view of Anastasiadis et al. (U.S. 10,638,770 B2).
Regarding claim 1, McCormick et al. discloses a method of making a zero-sugar and zero-net carb dairy product, the method comprising (i) providing a fermented dairy material having sugars and organic acids ([0037]-[0038]), (ii) adding a first volume of a dilution liquid to the material to form a first diluted dairy slurry ([0039]), and (iii) separating the first diluted dairy slurry into a first washed fermented dairy material and a first filtrate ([0040]-[0042]).
McCormick et al. does not disclose adding a second volume of the dilution liquid to the first washed fermented dairy material to form a second diluted diary slurry and separating the second diluted dairy slurry into a second washed fermented dairy material and a second filtrate.
However, Anastasiadis et al. discloses straining a yogurt product from two to eight consecutive times (C3, L64 – C4, L28) in order to obtain desired physiochemical features in the final product in terms of protein, fat, and total solids content (Abstract).
It would have been obvious to one having ordinary skill in the art to repeat the washing step of McCormick et al. as suggested in the method of Anastasiadis et al. Since McCormick et al. teaches that the washing step results in a reduced carbohydrate content ([0041]) and that the material obtained after the first wash may be further processed ([0043]), a skilled practitioner would be motivated to consult Anastasiadis et al. in order to determine that a process step may be performed repeatedly in order to further refine a product. As such, repetition of the wash step in order to further reduce the carbohydrate content would be obvious to a skilled practitioner. The subsequent method steps of adding a second volume of the dilution liquid to the first washed fermented dairy material to form a second diluted diary slurry and separating the second diluted dairy slurry into a second washed fermented dairy material and a second filtrate would thus be obvious. The instruction in McCormick et al. that the carbohydrate content may be reduced by “at least 5%” and “at least 95%” ([0075]) further suggests more intense processing may be necessary to remove carbohydrates over such a range of relative concentrations. Further, achieving a carbohydrate reduction of “at least 95%” is interpreted as effectively encompassing a reduction in carbohydrate content of 100%, which would result in a zero-sugar and zero-net carb dairy product.
As for claim 2, McCormick et al. discloses the fermented dairy material as being an animal-derived yogurt ([0071]-[0072]).
As for claim 4, a skilled practitioner would recognize that upon separation of the first diluted dairy slurry that some portion of the matter originally in the fermented dairy material would be separated into the first filtrate, such that the first washed fermented dairy material would have less material than the original fermented dairy material. Accordingly, the second wash would be presumed to necessitate less dilution liquid. Performing the second wash with a second volume of dilution liquid that is smaller than the first volume of dilution liquid would thus be obvious.
As for claim 5, McCormick et al. discloses combining 4 volumes of the fermented liquid dairy product with at least 1 volume of water ([0039]), which would cause the water to be 20% of the volume of the fermented dairy material, thus rendering the claimed range of 15-50% obvious.
As for claim 7, McCormick et al. discloses the first separation step as being performed by centrifugation ([0056]).
As for claim 8, McCormick et al. discloses the separation as being performed via ultrafiltration ([0056]), which renders the performance of the first and second filtration steps using one or more ultrafiltration membranes obvious.
As for claim 9, Anastasiadis et al. disclosed repeating a straining step from two to eight repetitions (C4, L23-L28), which renders the claimed method steps of adding a third volume of the dilution liquid to the second washed fermented dairy material to form a third diluted diary slurry and separating the third diluted dairy slurry into a third washed fermented dairy material and a third filtrate obvious.
As for claim 19, Anastasiadis et al. disclosed repeating a straining step from two to eight repetitions (C4, L23-L28), which renders the claimed method steps of adding a fourth volume of the dilution liquid to the third washed fermented dairy material to form a fourth diluted diary slurry and separating the fourth diluted dairy slurry into a fourth washed fermented dairy material and a fourth filtrate obvious.
As for claim 20, McCormick et al. discloses the carbohydrate content may be reduced by at least 95% ([0075]), which renders achieving a reduction in sugars of at least 60% relative to the starting fermented dairy material obvious. As for the organic acid content, McCormick et al. indicates the separated liquid is an acid whey ([0042], [0079]), where repeated wash steps would progressively lower the organic acid content. Since Anastasiadis et al. discloses repeated cycling of the separation, the organic acid content is considered a result-effective variable dependent on the number of wash cycles performed, as well as the organic acid content in the starting material and the efficiency of the wash cycles. Achieving any concentration of organic acid content lower than that of the starting material would thus be obvious, which renders the claimed organic acid content of 0.7 wt.% or less obvious.
Regarding claim 21, McCormick et al. discloses a method of making a zero-sugar and zero-net carb dairy product, the method comprising (i) providing a fermented dairy material having sugars and organic acids ([0037]-[0038]), (ii) performing a first wash cycle comprising adding a volume of a dilution liquid to the material to form a diluted dairy slurry ([0039]), and separating the diluted dairy slurry into a washed fermented dairy material and a filtrate ([0040]-[0042]).
McCormick et al. does not disclose performing one or more additional wash cycles.
However, Anastasiadis et al. discloses straining a yogurt product from two to eight consecutive times (C3, L64 – C4, L28) in order to obtain desired physiochemical features in the final product in terms of protein, fat, and total solids content (Abstract).
It would have been obvious to one having ordinary skill in the art to repeat the washing step of McCormick et al. as suggested in the method of Anastasiadis et al. Since McCormick et al. teaches that the washing step results in a reduced carbohydrate content ([0041]) and that the material obtained after the first wash may be further processed ([0043]), a skilled practitioner would be motivated to consult Anastasiadis et al. in order to determine that a process step may be performed repeatedly in order to further refine a product. As such, repetition of the wash step in order to further reduce the carbohydrate content would be obvious to a skilled practitioner. The subsequent method wash cycles of adding a volume of the dilution liquid to the first washed fermented dairy material to form a second diluted diary slurry and separating the second diluted dairy slurry into a second washed fermented dairy material and a second filtrate would thus be obvious. The instruction in McCormick et al. that the carbohydrate content may be reduced by “at least 5%” and “at least 95%” ([0075]) further suggests more intense processing may be necessary to remove carbohydrates over such a range of relative concentrations. Further, achieving a carbohydrate reduction of “at least 95%” is interpreted as effectively encompassing a reduction in carbohydrate content of 100%, which would result in a zero-sugar and zero-net carb dairy product.
As for claim 22, McCormick et al. discloses the treated dairy material as having a weight ratio of protein to carbohydrate of at least 7.8:1 ([0192]). As for the organic acid content, McCormick et al. indicates the separated liquid is an acid whey ([0042], [0079]), where repeated wash steps would progressively lower the organic acid content. Since Anastasiadis et al. discloses repeated cycling of the separation, the organic acid content is considered a result-effective variable dependent on the number of wash cycles performed, as well as the organic acid content in the starting material and the efficiency of the wash cycles. Achieving any concentration of organic acid content lower than that of the starting material would thus be obvious, which renders the claimed organic acid content of 0.7 wt.% or less obvious.
As for claim 23, McCormick et al. discloses the carbohydrate content may be reduced by at least 95% ([0075]), which renders achieving a reduction in sugars of at least 60% relative to the starting fermented dairy material obvious.
As for claim 24, McCormick et al. discloses the carbohydrate content may be reduced by at least 95% ([0075]), which renders achieving a reduction in sugars of at least 90% relative to the starting fermented dairy material obvious.
As for claim 25, McCormick et al. indicates the separated liquid is an acid whey ([0042], [0079]), where repeated wash steps would progressively lower the organic acid content. Since Anastasiadis et al. discloses repeated cycling of the separation, the organic acid content is considered a result-effective variable dependent on the number of wash cycles performed, as well as the organic acid content in the starting material and the efficiency of the wash cycles. Achieving any concentration of organic acid content lower than that of the starting material would thus be obvious, which renders the claimed relative concentration of at least 80% fewer organic acids in the treated material compared to the fermented dairy material obvious.
As for claim 26, McCormick et al. discloses the carbohydrate content may be reduced by at least 95% ([0075]), which renders achieving a reduction in carbohydrates of at least 90% relative to the starting fermented dairy material obvious.
As for claim 27, Anastasiadis et al. discloses performing up to eight repetitions of wash cycles (C4, L24-L28), which effectively renders any number of repetitions obvious in order to achieve a desired degree of component reductions. McCormick et al. teaches achieving less than 2.5% carbohydrates ([0093]), less than 0.5% total sugars ([0093]), and a protein to carbohydrate ratio of at least 7.8:1 ([0192]). As for the organic acid content, McCormick et al. indicates the separated liquid is an acid whey ([0042], [0079]), where repeated wash steps would progressively lower the organic acid content. Since Anastasiadis et al. discloses repeated cycling of the separation, the organic acid content is considered a result-effective variable dependent on the number of wash cycles performed, as well as the organic acid content in the starting material and the efficiency of the wash cycles. Achieving any concentration of organic acid content lower than that of the starting material would thus be obvious, which renders the claimed organic acid content of 0.7 wt.% or less obvious.
As for claim 28, McCormick et al. discloses combining the treated dairy material with a prep ([0214]).
As for claim 29, McCormick et al. discloses the prep as not including sugars or organic acids ([0214], where neither component is listed as being required).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over McCormick et al. (U.S. 2020/0120947 A1) in view of Anastasiadis et al. (U.S. 10,638,770 B2) as applied to claim 1 above, and further in view of Ramage et al. (U.S. 2016/0157503 A1).
As for claim 3, McCormick et al. and Anastasiadis et al. disclose the method of claim 1. McCormick et al. further discloses the product as being an animal-derived fresh cheese ([0071]-[0072]).
The cited prior art does not specifically disclose the fresh cheese as being cream cheese.
However, Ramage et al. discloses a method for processing a fermented dairy product that may be a yogurt or cream cheese ([0012]-[0013]).
It would have been obvious to one having ordinary skill in the art to produce a cream cheese via the method disclosed in McCormick et al. Since McCormick et al. discloses the production of a fresh cheese generally, a skilled practitioner would determine upon consultation of Ramage et al. that production of a cream cheese ([0013]) in particular would be a suitable type of fresh cheese, which renders the production of fresh cheese via the method of McCormick et al. obvious.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over McCormick et al. (U.S. 2020/0120947 A1) in view of Anastasiadis et al. (U.S. 10,638,770 B2) as applied to claim 1 above, and further in view of Kaschmieder et al. (U.S. 2020/0383344 A1).
As for claim 6, McCormick et al. and Anastasiadis et al. disclose the method of claim 1.
The cited prior art does not explicitly disclose recycling at least part of the first filtrate into part or all of the second volume of the dilution liquid.
However, Kaschmieder et al. discloses a method of concentrating fermented dairy products ([0044]), wherein the separated filtrate/whey is recycled into the process by combining the stream with the unseparated starting material ([0005]-[0006]).
It would have been obvious to one having ordinary skill in the art to recycle at least part of the first filtrate of McCormick et al. as modified by Anastasiadis et al. into the dilution liquid for subsequent wash cycles. First, McCormick et al. indicates the separated material is simply a by-product ([0079]). Anastasiadis et al. discloses the separated whey is “collected for other use” (C5, L13). A skilled practitioner would recognize at least some utility for such a product stream, especially should it be generated in large quantities. McCormick et al. additionally suggests that the dilution liquid may be material other than simply water ([0104]). As such, the practitioner would be motivated to consult Kaschmieder et al. to determine a use for the separated material. Since Kaschmieder et al. discloses the separated filtrate/whey may be recycled into the starting material, thus improving efficiency of the process by utilizing a byproduct stream, as well as to minimize fouling of equipment as taught in Kaschmieder et al. ([0007]), the claimed step of recycling at least part of the first filtrate into part or all of the second volume of the dilution liquid would be obvious to a skilled practitioner.
Double Patenting
Claims 1, 2, 5-9, and 19-28 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20, 23-25, 27, 29, 30, 33, 34, 36, and 38 of copending Application No. 18/209,535. Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims merely do not require the inclusion of the fruit-based material but are otherwise essentially equivalent to the claims of the ‘535 application, or are narrower in scope in terms of the claimed component concentration ranges, but would still be obvious in view of the co-pending claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Claim Rejections - 35 U.S.C. § 103 of claims 1, 2, 4, 5, 7-9, and 19-29 over McCormick et al. and Anastasiadis et al.; claim 3 over McCormick et al., Anastasiadis et al., and Ramage et al.; and claim 6 over McCormick et al., Anastasiadis et al., and Kaschmieder et al.: Applicant’s arguments have been fully considered but they are not persuasive.
Applicant first argued that a practitioner would not have found the performance of multiple wash cycles in which a volume of a dilution liquid is added to the fermented dairy material that is subsequently separated to be obvious (Applicant’s Remarks, p. 6, ¶2). Applicant asserted that Anastasiadis et al. discloses a process for making Greek yogurt that uses multiple straining steps but not dilution of the yogurt prior to straining (Applicant’s Remarks, p. 7, ¶2). Applicant argued that a skilled practitioner would not have combined the straining process of McCormick et al. with the multi-step straining process of Anastasiadis et al., since they are aimed at achieving different goals (Applicant’s Remarks, p. 7, ¶3). Applicant further argued that “further processing” as recited in McCormick et al. applies only to specifically-listed steps that do not include repeating the dilution/separation steps (Applicant’s Remarks, p. 8, ¶1).
However, Anastasiadis et al. is relied only for general instruction regarding the repeated performance of a step to further refine a product. The claim rejection does not rely on incorporating the actual straining steps of Anastasiadis et al. into the process of McCormick et al. Examiner maintains that the combination of references is adequate to deem the claimed repetition of dilution/separation steps obvious. The instruction in McCormick et al. that the carbohydrate content may be reduced by “at least 5%” and “at least 95%” ([0075]) further supports the determination that additional processing would be necessary to remove carbohydrates at the larger degree of reduction. Examiner maintains that repeating the dilution/separation step of McCormick et al. would be obvious in order to remove additional carbohydrates. Applicant’s argument that additional processing is limited only to specifically-listed steps that do not include repeating the dilution/separation steps relies on an improperly narrow reading of McCormick et al. and is consequently unpersuasive.
Applicant next argued that a skilled practitioner combining the two references would result in a process involving repeated straining steps but not repeated dilution/separation steps (Applicant’s Remarks, p. 8, ¶2 - p. 9, ¶3).
As noted previously, the claim rejection is based on combining references in order to deem the repetitio of the dilution/separation steps obvious. The claim rejection does not rely on actually incorporating process steps from the method of Anastasiadis et al. into the process of McCormick et al. Examiner maintains that the combination of references is adequate to deem the claimed process obvious. Applicant’s argument is unpersuasive due to relying on an interpretation of the claim rejection that does not correlate with the claim rejection of record.
Applicant then argued that nothing in McCormick et al. suggests a zero-sugar/zero-net carb dairy product could be obtained via repetition of dilution and separation steps, asserting that the degree of carbohydrate reduction achieved in the examples does not approach the disclosed range of “at least 95%” (Applicant’s Remarks, p. 9, ¶4 – p. 10, ¶1).
However, MPEP 2123 II states: “Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments.” McCormick et al. explicitly states that a carbohydrate reduction of “at least 95%” may be achieved ([0075]). That the examples in the reference do not achieve a comparable degree of carbohydrate reduction does not undermine the claim rejection.
Applicant argued the rejections of claims 3 and 6 were improper due to their dependence on parent claim 1 (Applicant’s Remarks, p. 10, ¶2 – p. 11, ¶1).
Examiner maintains that the rejection of claim 1 is proper and that the rejections of dependent claims 3 and 6 are likewise proper.
The rejections of claims 1-9, and 19-29 have been maintained herein.
Double patenting: Applicant asserted that the present claims differ from those of the ‘535 application due to the co-pending claims reciting that a fruit-based material is added to the fermented dairy material prior to the multiple wash cycles (Applicant’s Remarks, p. 11, ¶2).
However, since the present claims do not require the inclusion or omission of a fruit-based material, the present claims would still be obvious in view of the co-pending claims that additionally include the addition of a fruit-based material. Applicant’s argument is unpersuasive.
The double patenting rejections have been updated (based on amendments to the claims in the co-pending application) and maintained herein.
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.
Claims 1-9 and 19-29 are rejected.
No claims are allowed at this time.
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/JEFFREY P MORNHINWEG/Primary Examiner, Art Unit 1793
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