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 Claims
Receipt of Remarks/Amendments filed on 06/30/2026 is acknowledged. Claims 1-2, 5-7, 9-10, and 12-28 are pending. Claims 3-4, 8, and 11 are cancelled. Claims 17-23 are non-elected claims, and are withdrawn. Claims 1-2, 7, 9-10, 14-16, and 24-27 have been amended. Claim 28 is new. Claims 1-2, 5-7, 9-10, 12-16, and 24-28 are presented for examination on the merits for patentability.
Rejection(s) not reiterated from the previous Office Action are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set of rejections presently being applied to the instant application.
Modified Rejection As Necessitated by the Amendment Filed 06/30/2026
Claim Objections
Claims 1, 2, 5, 7, 9, 12, 14, and 27-28 objected to because of the following informalities:
In some cases, the liquid composition in the claim set is referred to as “liquid dairy composition”, and in some cases, they are not. For consistency, Applicant is requested to recite “dairy” when reciting “liquid composition” in Claims 1, 2, 5, 9, 12, 14, and 27-28.
Similarly for Claim 7, the “solid ingredient” should be amended to “solid dairy food ingredient” to be consistent with Claim 1.
Appropriate correction is required.
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 1-2, 5-7, 9-10, 12-16, and 24-28 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.
Amended Claim 1 and new Claim 28 recite “a mass ratio of the total nitrogenous matter…80%” and “a mass ratio of the micellar caseins…80%”, which appears to refer to ratios of TNM to TDM, and micellar caseins to TNM, respectively. However, the values are presented in percentages, and it is particularly unknown what the denominator is. For example, for “a mass ratio of the total nitrogenous matter…80%”, one skilled in the art would not know if the 80% is based on the total composition, the TDM, TDM plus TNM, or something else. Clarification is required. All claims depending from Claim 1 are also rejected.
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.
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, 5-6, 10, 14-16 and 24-28 are rejected under 35 U.S.C. 103 as being unpatentable over Boursier et al. (US 2015/0237885 A1; Of record), hereinafter Boursier, in view of Cuksey et al. (WO 2005/013710 A1, cited in the IDS), hereinafter Cuksey.
Boursier discloses a method of producing an assembly of at least one dairy protein and at least one vegetable protein (Abstract). The composition may be in solid or liquid form (Claim 1). The invention relates to gelling and viscosifying agents useful in preparation of dairy products, for example, cheeses (Claims 15 and 17).
Regarding Claim 1 step i), Boursier teaches producing protein assemblies using a milk fraction, which contain 92% caseins micelles based on the total nitrogenous matter, and is in liquid form (retentate at 15% dry matter), and pea proteins (Example 1). In one preferred embodiment, the protein isolate/concentrate in the composition is casein, and the dairy protein isolates has a total protein of at least 85% on dry matter, which meets the TNM greater than or equal to 80% in Claims 1 and 10 [0102]. A solution of the micellar casein (PROMILK 852 B milk protein) was prepared at 64mg/mL, and pea protein at 16 mg/mL, and the two solutions mixed at 50/50 ratio (Example 1). By Examiner’s calculation, the micellar casein is present at ~80% of the total dry mass of proteins. Boursier also teaches the combination of caseins and caseinates with other products such as demineralized whey, permeates milk or whey, wherein whey contains 10-13% soluble proteins ([0095], [0109]). Boursier does not require fat, and teaches skimmed milk, and caseins being obtained from skimmed milk, which reads on the at most 10 wt% and 5 wt% fat in Claims 1 and 9, respectively [0104].
Regarding Claim 1 step ii), Boursier teaches the usefulness of transglutaminases in improving properties in its invention comprising proteins, such as by crosslinking the proteins, which facilitates gelation [0158]. However, Boursier does not teach the claimed concentration of TG, and the conditions for the addition of transglutaminase.
Cuksey discloses a process of producing a protein composition comprising whey protein and casein, and wherein transglutaminase (TG) is added (Abstract; Claim 1). Cuksey teaches adding transglutaminase at a rate of about 0.5 and 10, preferably between about 0.5 and 5, units of enzyme per gram of milk protein, which overlaps with the claimed TG concentration (Claim 14). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", a prima facie case of obviousness exists. See MPEP 2144.05. As such, the feature in Claim 24 is also obvious.
Regarding Claim 1 step iii) and iv), Cuksey expressly teaches adding a transglutaminase enzyme to a dairy stream while maintaining the pH between 6-8 and the temperature within the range of 20°C to 65°C for a time sufficient to form a protein composition and then deactivating the tranglutaminase enzyme (p. 5, lines 5-14). The stream is cooled, and the casein coagulated, which reads on the solid dairy ingredient in steps v) and vi) (p. 5, lines 15-24). Cuksey also expressly teaches precipitating protein from milk heating milk to 50°C and adding TG enzyme a ratio of 1:2500 enzyme:protein, and holding the temperature for approximately 2.5 hours at 50°C (Example 5, lines 18-21). As such, Claims 2 and 27 are also rendered obvious.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine the teachings of Cuksey with that of Boursier, and use the conditions and concentration taught by Cuksey for the transglutaminase when coagulating the proteins to make cheese, for example. It can be expected that using the concentration and conditions for adding transglutaminase to the casein-containing liquid composition would lead to successful coagulation. Applying a known technique to a known method ready for improvement to yield predictable results is the rationale supporting obviousness. See MPEP § 2143 and KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007).
Regarding Claim 5, Boursier teaches pasteurization and thermization of the solution to destroy microorganism pathogens [0114]-[0115].
Regarding Claim 6, Boursier teaches spray drying of the liquid to turn it into dry powder [0202]-[0204].
Regarding Claims 14 and 16, Boursier also teaches enzyme inactivation by heat treatment, coagulation, and drying ([0070], [0111], [0202-[0204]). As discussed above, Cuksey teaches the deactivation temperature for TG to be within the range of 20°C to 65°C (p. 5, lines 5-14). This is the same as the instantly claimed steps, which the inventors observed reduces the quantity of cross-linked caseins having molecular weights greater than 400,000 Daltons; between 10% and 50%, preferably between 20% and 50%, more preferably between 30% and 50%, of the proteins in the liquid composition have molecular weights greater than or equal to 400,000 Daltons (Specification, p. 9, lines 22-35; p. 10, line 36 to p. 11, line 15). Because the prior art and the instant invention teaches the same methods and compositions, one skilled in the art would expect the same composition, i.e. “wherein between 10% and 50% of the proteins of said solid ingredient have molecular weights greater than or equal to 400,000 Daltons” based on the teachings of the prior art.
One of ordinary skill in the art would have found it obvious to adjust the degree of cross-linking, and thereby the molecular weights of the coagulated protein, as a matter of experimentation and optimization. The adjustment of particular conventional working conditions is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
Regarding Claim 15, Boursier teaches cheese, which reads on the solid dairy food ingredient (Claims 15 and 17).
Regarding Claims 25-26 and 28, Boursier teaches that intramicellar cross-linked casein micelles have sizes similar to native casein micelles, i.e. average diameter of about 200 nm, whereas the particle size of intermicellar cross-linked casein will be much larger than 200 nm (p. 12, 1-4; Fig. 1).
Boursier is in a related field and teaches a composition comprising at least one vegetable protein and at least one dairy protein, wherein the dairy protein comprises casein, in particular a micellar casein retentate (Claim 6; Example 1). Boursier teaches a powder form of the composition [0207]. In one embodiment, 50% of the powder (d-50) has a diameter less than 500 µm [0211]. The mean size of the powder obtained can be characterized by its volume mean diameter D4,3, which is preferably between 10 µm and 500 µm [0208]. One would then have optimized the size or cumulative volume of particles depending on the desired functional and/or sensory properties of the powder ingredient as well as the final product.
Claims 7 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Boursier in view of Cuksey, as applied to Claim 1 above, and further in view of De Kort (WO 2015/156672 A1; Of record), hereinafter De Kort.
The teachings of Boursier and Cuksey have been set forth supra. The reference is silent on the degree of crosslinking.
Regarding Claim 7, De Kort teaches an embodiment wherein the powder comprises transglutaminase-treated cross-linked micellar casein (TGMC) wherein the cross-linked micellar casein is present in at least 30 wt.%...even more preferably between 40-100 wt.%...based on the dry weight of the powder, which overlaps with the claimed range (p. 17, lines 1-8). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", a prima facie case of obviousness exists. See MPEP 2144.05.
Boursier already recognizes TG as a particularly advantageous enzyme for modifying the functional properties in its invention comprising micellar casein by crosslinking the proteins.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine the teachings of De Kort, which is in the same field, and also teaches micellar casein, with that of Boursier, and use the concentrations of TG as starting point for crosslinking the caseins, and modifying the degree of crosslinking depending on the desired hardness or strength of gelation/coagulation.
Regarding Claims 12-13, Boursier teaches that whey contains lactose, soluble proteins, vitamins and minerals, which are essentially calcium [0087]. However, Boursier does not teach the amount of calcium. De Kort teaches normal micellar casein contains about 0.8 - 3.4 wt.% calcium based on protein content, and teaches an embodiment wherein the powder composition comprises at least 30 wt.% TGMC ,and less than 0.8 wt.% calcium based on total protein content (p. 19, lines 1-3). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine the teachings of Boursier and De Kort, and refer to the concentration of calcium in De Kort with regards to the amount of calcium, and modifying depending on the calcium need for the product into which the ingredient is being used. Obviousness is established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so. See MPEP § 2143.01 and KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007).
Response to Remarks:
Applicant’s argument with regards to the cited art failing to teach all the elements claimed appears to be centered around the amendment, which now recites that i) the whey proteins in an amount higher than 0% and less than or equal to 20%; ii) the lowered transglutaminase dose; iii) the lowered fat content; iv) the solid food ingredient is solid dairy food ingredient; v) the molecular weight distribution. Applicant argues that these features are not taught by De Kort, and there’s no expectations of success.
Applicant’s arguments have been considered but are moot because the new ground of rejection necessitated by the amendment does not rely on De Kort for any teaching or matter specifically challenged in the argument. De Kort is no longer the primary art, and is now only relied on to teach the calcium amount in Claims 7 and 12-13. Boursier in view of Cuksey teaches the amended features.
Regarding the expectations of success, Applicant reminded that applying a standard of absolute predictability in order to find obviousness is not required. Rather, to find obviousness, only a reasonable expectation of success is required, which is provided. Please MPEP 2143.02 and In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976). From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Jackson et al. (US 2018/0000102 A1), discloses a method for reducing the immunoreactivity of a food including (a) incubating a food that contains at least one protein inter alia casein, with a cross-linking enzyme to form a food that includes at least one cross-linked protein; and (b) fermenting the food (Abstract; Claims 9, 12, 14). Jackson et al. teaches a modified food wherein at least 10% of the polypeptides in the hydrolysate range from about 50,000 daltons and 500,000 daltons (Claim 17).
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 JANICE Y SILVERMAN whose telephone number is (571)272-2038. The examiner can normally be reached M-F, 10-6 EST.
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/J.Y.S./Examiner, Art Unit 1792
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791
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