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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 11, 2026 has been entered.
Claims 21-32 are new. Claims 1-6 and 21-32 are pending examination.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 27-30 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
New claim 27 recites “where said protein profile has a substantially open cell structure.”. There is no support in the claims or specification, as originally filed, for this limitation. Nowhere in the present specification is the cell structure of the protein or fortified high protein food disclosed.
Claims 28-30 are rejected because they are dependent from a rejected base claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-6, 26 and 28-32 are rejected under 35 U.S.C. 103 as being unpatentable over Ning et al. (US 2008/0102165).
Regarding claims 1-4, Ning et al. disclose an extruded high protein product comprising protein, a leavening agent (wherein the leavening agents includes sodium bicarbonate) and water ([0018], [0020], [0039], [0044] – wherein water can be introduced into the extruder barrel, [0050]). Ning et al. disclose the extruded high protein product can comprising about 60% protein and about 40% starch ([0036]).
Ning et al. disclose where the protein can be a dairy protein selected from the group consisting of casein, caseinates and whey protein and mixtures thereof ([0020]).
Given Ning et al. disclose an extruded high protein product comprising about 60% protein wherein the protein can be a dairy protein, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the present application to have used any combination of the disclosed dairy proteins, including casein and whey in any proportion including wherein the protein content comprises from 15% to 35% by weight whey protein and from 65% to 85% by weight casein with a reasonable expectation of success.
While Ning et al. does not explicitly disclose using acid casein to make the extruded high protein product, given the claims are directed to a product and the claimed product comprises casein, the process of obtaining the casein from acid casein is not determinative of patentability. Here, the determination of patentability is based on the product itself and not defined by the process (see MPEP §2113).
Ning et al. also disclose the extruded high protein product comprises a nutrient such as a vitamin and a mineral ([0075]. Ning et al. disclose suitable vitamins including vitamins A, B, C, D and E and examples of minerals including the salts of aluminum, ammonium calcium magnesium and potassium ([0075]).
Regarding claim 5, Ning et al. disclose all of the claim limitations as set forth above. Ning et al. disclose the extruded high protein product has a moisture content of about 9% to about 12% ([0061]).
Regarding claim 6, Ning et al. disclose all of the claim limitations as set forth above. Ning et al. disclose the extruded high protein product has a bulk density from 0.2 g/cm3 to 0.4 g/cm3 (i.e., 200-400 g/L - [0054]).
Regarding claims 21-24, 26 and 28-30, Ning et al. disclose an extruded high protein product comprising protein, a leavening agent (wherein the leavening agents includes sodium bicarbonate) and water ([0018], [0020], [0039], [0044] – wherein water can be introduced into the extruder barrel, [0050]). Ning et al. disclose the extruded high protein product can comprising about 60% protein and about 40% starch ([0036]).
Ning et al. disclose where the protein can be a dairy protein selected from the group consisting of casein, caseinates and whey protein and mixtures thereof ([0020]).
Given Ning et al. disclose an extruded high protein product comprising about 60% protein wherein the protein can be a dairy protein, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the present application to have used any combination of the disclosed dairy proteins, including casein and whey in any proportion including wherein the protein content comprises from 15% to 35% by weight whey protein and from 65% to 85% by weight casein with a reasonable expectation of success.
While Ning et al. does not explicitly disclose using acid casein to make the extruded high protein product, given the claims are directed to a product and the claimed product comprises casein, the process of obtaining the casein from acid casein is not determinative of patentability. Here, the determination of patentability is based on the product itself and not defined by the process (see MPEP §2113).
Ning et al. disclose the extruded high protein product has a bulk density from 0.3 g/cm3 to 1.5 g/cm3 (i.e., 300-1500 g/L - [0054]). While Ning et al. does not disclose the precisely claimed bulk density, a prima facie case of obviousness exists where the claimed ranges or amounts does not overlap with the prior art but are merely close (MPEP §2144.05). With regards to claims to claim 26, while Ning et al. does not disclose a bulk density value of less than 300 g/L, a prima facie case of obviousness exists where the claimed ranges or amounts does not overlap with the prior art but are merely close (MPEP §2144.05).
Ning et al. also disclose the extruded high protein product comprises a nutrient such as a vitamin and a mineral ([0075]. Ning et al. disclose suitable vitamins including vitamins A, B, C, D and E and examples of minerals including the salts of aluminum, ammonium calcium magnesium and potassium ([0075]).
Regarding claims 25 and 31, Ning et al. disclose all of the claim limitations as set forth above. Ning et al. disclose the extruded high protein product has a moisture content of about 9% to about 12% ([0061]).
Regarding claim 32, Ning et al. disclose all of the claim limitations as set forth above. While Ning et al. disclose an extruded high protein product having a bulk density ranging from 300 to 1500 g/L, the reference is silent with a bulk density of between 150 and 200 g/L.
Given Ning et al. is directed to a crispy snack having a high protein and low fat content ([0007]), it would have been obvious to one of ordinary skill in the art to have adjust parameters in the extrusion process, e.g., temperature, screw speed and moisture to obtain an extruded high protein product with a desired texture (as measured by bulk density), including a bulk density of 200 g/L.
Response to Amendment
The Declaration under 37 CFR 1.132 filed February 11, 2026 is insufficient to overcome the rejection of claims 1-6 based upon Ning et al. (US applied under 35 U.S.C. 103 as set forth in the last Office action.
At paragraph 14a Declarant notes Ning et al. disclose “substantially closed cell structure.” Declarant explains cow milk is not a protein with a substantially closed cell structure.
Here, independent claims 1, 21 and 26 do not require the protein profile have an open cell structure. Regardless, while Ning et al. disclose the expanded extruded protein composition with protein matrices that have a substantially closed cell structure, this is not the same as a protein with a closed cell structure. Ning et al. discusses the cell structured of the expanded and extruded protein composition and not the protein itself. Given Ning et al. disclose a composition comprising dairy protein, i.e., casein and whey, inherently the proteins would exhibit an open cell structure.
Note rejection of claim 27 under 35 U.S.C. 112 (a) set forth above. There is no support to claim the “protein profile has a substantially open cell structure.
At paragraph 14b Declarant submits Ning et al. makes no recognition of a need for a fortified high protein food that has a protein profile similar to that of cow’s milk with a protein content of 15-35% and the only protein source is casein and whey protein.
The Examiner agrees, Ning et al. does not acknowledge the extruded product comprises protein having a profile similar to cow’s milk with a protein content of 15-35% and the only protein source is casein and whey protein.
However, Ning et al. disclose an extruded high protein product comprising protein, a leavening agent (wherein the leavening agents includes sodium bicarbonate) and water ([0018], [0020], [0039], [0044] – wherein water can be introduced into the extruder barrel, [0050]). Ning et al. disclose the extruded high protein product comprises about 60% protein and about 40% starch ([0036]). Ning et al. disclose where the protein can be a dairy protein selected from the group consisting of casein, caseinates and whey protein and mixtures thereof ([0020]).
Given Ning et al. disclose an extruded high protein product comprising about 60% protein wherein the protein can be a dairy protein, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the present application to have used any combination of the disclosed dairy proteins, including casein and whey in any proportion including wherein the protein content comprises from 15% to 35% by weight whey protein and from 65% to 85% by weight casein with a reasonable expectation of success.
In this case, there is no evidence on the record demonstrating the criticality of the claimed ranges on the properties of the claimed fortified high protein food product.
Note, independent claims 1, 21 and 26 do not require a protein content of 15-25%. Rather, the independent claims require the protein content comprise 15-25% by weight whey protein and from 65-85% by weight casein.
At paragraphs 15 and 16 Declarant state “[t]here is minimal discussion of combining dairy proteins and plant proteins and no discussion of how to combine dairy proteins and plant proteins.”
Ning et al. does not require the extruded protein composition comprises a combination of dairy protein and a plant protein. Ning et al. disclose while ingredient comprising proteins derived from plants are typically used, it is also envisioned that proteins derived from other sources, such as animal source, may be utilized without departing from the scope of the invention ([0020]). Ning et al. disclose , for example, a diary protein selected from the group consisting of casein, caseinates, whey protein, milk protein concentrate, milk protein isolate and mixtures thereof may be utilized ([0020]). Nowhere does Ning et al. disclose the extruded protein composition must comprise a plant protein.
Response to Arguments
Applicant's arguments filed February 11, 2026 have been fully considered but they are not persuasive.
See Response to Amendment set forth above.
Regarding new claims 21-32, Applicant submits Ning et al. does not disclose density of less than 300 g/L.
Applicant is directed to paragraph [0054] of Ning et al. disclose the extruded high protein product has a bulk density from 0.3 g/cm3 to 1.5 g/cm3 (i.e., 300-1500 g/L - [0054]). While Ning et al. does not disclose a bulk density value of less than 300 g/L, a prima facie case of obviousness exists where the claimed ranges or amounts does not overlap with the prior art but are merely close (MPEP §2144.05). The claimed bulk density is so close that of the prior art, Ning et al, prima facie one skilled in the art would have expected them to have the same properties of effect.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH A GWARTNEY whose telephone number is (571)270-3874. The examiner can normally be reached M-F: 9 a.m. - 5 p.m. EST.
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ELIZABETH A. GWARTNEY
Primary Examiner
Art Unit 1759
/ELIZABETH GWARTNEY/Primary Examiner, Art Unit 1759
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