DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The Amendment filed December 15, 2025 has been entered. Claims 1-22 are pending.
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 1-19, 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Mimouni et al. (WO 2025/073700).
Regarding claims 1-3, 6, 8, 9, 12 and 17, Mimouni et al. disclose a method for preparing a gel (i.e., substitute dairy product) comprising the steps of : (a) providing an aqueous solution comprising from 3 to 15% w/w recombinant β-lactoglobulin protein (rBLG); (b) heating the aqueous solution of rBLG to a temperature from 65° to 95°C for 1 to 30 minutes; (c) cooling the heated aqueous solution of rBLG; to a temperature lower than the denaturation temperature to obtain a cold gellable composition; (d) adding lipid to the cold gellable composition and (e) acidifying the solution of the cold gellable composition by adding glucono-delta-lactone, culture microorganisms such as lactic acid bacteria (i.e., cheese-making culture) or food grade acid to form a gel (i.e., substitute dairy product – p.3/L1-9, p. 9/L6-13, p. 12/L1-p.13/L18, p. 17/L23-p.19/L25, p. 27/L5-26).
While Mimouni et al. disclose adding lipid to the cold gellable composition, the reference is silent with respect to an amount. Given Mimouni et al. disclose a step of making a gel (i.e., substitute dairy product) from the cold gellable composition, one of ordinary skill in the art would have been motivated to adjust, in routine processing, the amount of lipid in the cold gellable composition to obtain a gel having the desired flavor and nutritional properties while maintaining the gel structure.
Given Mimouni et al. disclose a method for preparing a cold gellable composition substantially similar to that presently claimed, including heating an aqueous solution of rBLG under temperature and time conditions overlapping those of the present disclosure, inherently the heating would cause the claimed denaturation and viscosity increase.
Regarding claim 4, Mimouni et al. disclose all of the claim limitations as set forth above. Mimouni et al. disclose the aqueous protein solution of step (a) is adjusted to a pH in the range of 5 to 8 (p. 13/L15). The present specification ([0075]) states a pH substantially different from the isoelectric point includes a pH about 6.2 and below a pH of 3.8. Mimouni et al. disclose a pH substantially different from the isoelectric point of the rBLG.
Regarding claim 5, Mimouni et al. disclose all of the claim limitations as set forth above. Given Mimouni et al. disclose an aqueous solution of rBLG identical to that presently claimed, inherently the composition would comprise less than about 0.05% w/w calcium.
Regarding claim 7, Mimouni et al. disclose all of the claim limitations as set forth above. Mimouni et al. disclose heating the aqueous solution of rBLG to a temperature from 65° to 95°C for 1 to 30 minutes ( p. 17/L23-p.19/L25).
Given Mimouni et al. disclose a process of heating the aqueous solution of rBLG at a range of temperatures and time overlapping with those of the claimed method, it follows that the minimum denaturation required to achieve a gel (i.e., substitute dairy product) with a cheese-like texture would be dependent on the protein level.
Regarding claim 10, Mimouni et al. disclose all of the claim limitations as set forth above. Given Mimouni et al. disclose the formation of a gel (i.e., substitute dairy product) from rBLG, it necessarily follows the gel would comprise one of a crumbly, smooth or elastic texture.
Regarding claim 11, Mimouni et al. disclose all of the claim limitations as set forth above. While, Mimouni et al. disclose that hardness of gels formed from a solution of 7% cold gellable rBLG is about 3.1 N (p. 44/Table 5 – where 1 g = 0.0098066 N), the reference is silent with respect to gels having a hardness of 15N. However, given the data from Table 5 of Mimouni et al. shows that as protein concentration increases (e.g., from 5 to 7% w/w), hardness increases, 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 adjusted the protein concentration of the aqueous cold gellable composition to obtain a gel (i.e., substitute dairy product) having a desired hardness.
Regarding claim 13, Mimouni et al. disclose all of the claim limitations as set forth above. Mimouni et al. disclose lipids including lipids from non-animal sources (p. 29/L12-23).
Regarding claim 14, Mimouni et al. disclose all of the claim limitations as set forth above. Mimouni et al. also disclose an embodiment including a step of drying the cold gellable composition before the acidification step to obtain a dry cold gellable composition. Mimouni et al. disclose dissolution of the dry cold gellable composition includes a step of homogenizing with a mix of other food ingredient, e.g., lipids (p. 27/L1-4).
Regarding claim 15, Mimouni et al. disclose all of the claim limitations as set forth above. While Mimouni et al. disclose adding lipids to the cold gellable composition, the reference also discloses the aqueous solution of rBLG may comprise one or more lipids in a concentration lower than 1% w/w (p. 17/L15-21).
Regarding claim 16, Mimouni et al. disclose all of the claim limitations as set forth above. Mimouni et al. disclose adding salt, e.g., calcium, at the acidification step (p. 27/L27-p. 28/L2). Mimouni et al. is silent with respect to aggregation. Here, limited aggregation is considered to include no aggregation.
Regarding claim 18, Mimouni et al. disclose all of the claim limitations as set forth above. Mimouni et al. also disclose adjusting the pH of the cold gellable composition to a pH of 4 and 6 during the acidification step (p. 27/L5-7).
Regarding clam 19, Mimouni et al. disclose all of the claim limitations as set forth above. Mimouni et al. disclose wherein the cold gellable composition is processed into a cheese, e.g., soft, semi-soft, hard and soft ripened cheeses (p. 7/L22-p.8/L10).
Regarding claim 21, Mimouni et al. disclose all of the claim limitations as set forth above. Mimouni et al. disclose adding nutrients, including vitamins and minerals that can be found in a mammal-produced milk (p. 30/L17-p. 31/L5).
Regarding claim 22, Moumouni et al. disclose all of the claim limitations as set forth above. Mimouni et al. disclose the gel can comprises one or more of animal-derived milk proteins including β-lactoglobulin, serum albumin, lactoferrin and transferrin (p. 32/L12-30). The resulting gel would necessarily be considered a “hybrid” substitute dairy product because it would comprise both the rBLG and animal-derived proteins.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Mimouni et al. (WO 2025/073700) as applied to claim 1, and further in view of Shaw (“Modern cheesemaking: Soft Cheeses”, in Modern Dairy Technology, R.K Robinson (ed.), Chapman & Hall, 1993, pp. 221-280).
Regarding claim 20, Mimouni et al. disclose all of the claim limitations as set forth above. While Mimouni et al. disclose soft ripened cheese (e.g., brie or camembert-p. 7/L22-p.8/L10), it does not disclose the conditions for ripening.
Shaw teaches cheesemaking processes for soft cheeses (p. 221). Shaw taches that in traditional manufacture of surface mold-ripened softer cheeses such as brie and camembert, the cheeses, after removal from moulds are ripened at a temperature of between 11° and 13°C and relative humidity of 90-95% from 3 weeks to 1 month (p. 251-252/Soft Ripened Cheeses).
Mimouni et al. and Shaw are combinable because they are concerned with the same field of endeavor, namely soft ripened cheeses. Given Mimouni et al. discloses soft ripened type cheeses, 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 ripened the soft ripened cheese product using traditional processes, as taught by Shaw.
Response to Arguments
Applicant's arguments filed December 15, 2025 have been fully considered but they are not persuasive.
Applicant explains “the instantly disclosed and claimed method related to making a food product that would be directly consumed.” Applicant submits “[i]n contrast, Mimouni is focused on method of making a cold-gellable rBLG. Applicant explains “[o]ptionally, the method further comprises cooling, concentrating and/or drying the cold-gellable rBLG, e.g., to provide a dry cold gellable rBLG.” Applicant argues “one of ordinary skill in the art would not consider the cold-gellable rBLG made according to the method of Mimouni the same as a “substitute dairy product” of the instantly claimed method, such as a cheese.”
The present specification states “substitute dairy food product” or “animal-free substitute dairy food product” are intended to include all types of products that contain no milk that comes from cows, goats or other mammals and are devoid of ingredients derived directly from the milk, but yet designed and produced to mimic their corresponding animal -based dairy products. Mimouni et al. teaches a method of not only making a cold-gellable rBLG but also a step of acidifying a solution of the cold-gellable rBLG to produce a gel. Here, there is nothing to suggest the resulting gel could not be directly consumed and would not act as a substitute for cheese. Note, the method of making cold-gellable rBLG gels is substantially similar to the claimed method of producing a substitute dairy food product (claims 1 and 2).
Moreover, Mimouni et al. also disclose the cold-gellable rBLG can be mixed with other food ingredients and can be processed into dairy-type food products, e.g., processed cheese or hard cheese (). The method of claim 1 does not exclude additional steps.
Applicant notes “[i]nstant claim 1 recites a protein concentration of at least about 10% w/w.” Applicant explains “although Mimouni generally describes that the protein concentration of the solution to be heated an be 3 to 15% w/w, the successful working examples of mimouni focus on protein concentrations of 5% w/w or 7% w/w. Applicant notes that Example 5A of Mimouni shows that it was not possible to make a cold-gellable rBLG using a solution of 9.5% w/w BLG.
Note, Example 5A is directed to gelling capacity of rBLG according to the state of the art wherein an aqueous rBLG solution (9.5% w/w) according to the invention was prepared and functionalized according to the process disclosed in Food Hydrocolloid 2005, pages 269-278 (p. 41/L18-p. 42/L7). This is example does not use the presently claimed method of functionalizing a rBLG.
Applicant submits “Mimouni describes that it is preferable that only very small amounts of lipid be present in solution of rBLG. Applicant notes “Mimouni explicitly describes that the lipids are “preferably with a concentration lower than 1% w/w, or even lower than 0.5% w/w).
A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments (MPEP §2123). While amounts of less than 1% w/w are preferred, the reference does not teach away from compositions comprising more than 1% w/w. Note, Mimouni et al. disclose that when making dairy product comprising the cold-gellable rBLG, additional lipid can be added (p. 28/L21-23, p. 29/L12-21, p. 31/L6-19).
Regarding claim 10, Applicant submits one of ordinary skill in the art would understand what is meant by the term “crumbly”, “smooth” and “elastic” in terms of dairy products such as cheeses.
Here, the gel of Mimouni et al. is considered to exhibit one of the claimed texture attributes, i.e., crumbly, smooth or elastic since it is made by a method substantially similar to the claimed method.
Regarding claim 11, Applicant submit, given Mimouni’s attempt to increase protein concentration to 9.5% w/w was not successful in preparing a cold-gellable rBLG, it would not have been obvious to increase the protein concentration significantly above 7% w/w to obtain a desired hardness,
As discussed above, Mimouni et al. does not show that a cold-gellable rBLG cannot be formed at a protein concentration of 9.5% w/w.
Regarding claim 15, Applicant submits one of ordinary skill in the art would not have considered adding 2% w/w lipid to a rBLG solution prior to heating the solution to denature the BLG because emulsions can have different gelation properties.
First, claim 15 does not require that an emulsion be formed between the BLG and lipid prior to the denaturation step. Claim 15 only requires the lipid component be added prior to the denaturation step. Moreover, there is no evidence on the record demonstrating that the cold-gellable rBLG of Mimouni et al. would not gel if lipid was added and emulsified with the rBLG prior to the denaturation step.
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.
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