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 upon entry of the present amendment stands as follows:
Pending claims: 1-18
Withdrawn claims: None
Previously cancelled claims: None
Newly cancelled claims: 10-18
Amended claims: 9
New claims: 19-29
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
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, 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
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, 5-9, and 19-28 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 6-9, 20, 23-25, and 27 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEFFREY P MORNHINWEG whose telephone number is (571)270-5272. The examiner can normally be reached 8:30AM-5:00PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Emily Le can be reached at 571-272-0903. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JEFFREY P MORNHINWEG/Primary Examiner, Art Unit 1793