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 .
Response to Restriction and Status of Claims
Applicant’s election with traverse of the invention of Group I (Claims 1-16 and 24-27), drawn to a method for producing a solid food ingredient, in the reply filed 11/14/2025, is acknowledged by the Examiner. Applicant argues that the claim set is not obvious over Rudie et al. (WO 00/32055,cited in the International Written Opinion), cited in the previous office action, as amended. However, the Examiner maintains the Unity of Invention restriction requirement as the amended claimed invention is still not above prior arts as described in the rejection herein (Vide infra). Briefly, the shared technical feature lacks novelty or inventive step because De Kort et al. (WO 2015/156672 A1, cited in the International Written Opinion), hereinafter De Kort, has taught the technical feature. De Kort discloses a liquid composition comprising micellar casein, which is cross-linked using transglutaminase (TG) (Abstract; Claim 1). The protein comprises at least 30 wt.%, micellar casein based on total protein (Claim 2; Table 1). The micellar casein solution is preferably filtered in order to remove the whey fraction (p. 22, lines 9-14). De Kort teaches defatted milk is a suitable protein source and teaches a composition with a fat content between 6-25 wt.% (p. 18; lines 6-12; p. 23, lines 17-23). The TG concentration for crosslinking is between 5-100 Units/g protein, which is near the claimed amount(p. 22, lines 27-28). De Kort teaches inactivation of the enzyme, and the composition with cross-linked micellar casein may conveniently be concentrated or dried for further use, rendering the claimed solid ingredient obvious (p. 23, lines 12-15; p. 24, lines 12-14).
As such, the technical feature is not above the prior art, and therefore is not a special technical feature. As the technical feature was known in the art at the time of the invention, this cannot be considered a special technical feature. Therefore, the technical feature claim elements are expressly taught or are rendered obvious by De Kort. The technical feature is not above the prior arts, and therefore is not a special technical feature. The requirement is still deemed proper and is therefore made FINAL.
Claims 17-23 are withdrawn pursuant to 37 C.F.R. 1.142(b) as being drawn to non-elected subject matter. Claims 24-27 are new, and included in Group I. The claims corresponding to the elected subject matter are Claims 1-16 and 24-27, and are herein acted on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/26/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement was considered by the Examiner.
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 3-4 and 7 are 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.
Claim 7 recites the limitation “the degree of cross-linking of proteins”, which lacks antecedent basis because Claim 1 from which it Claim 7 depends does not recite any degree of cross-linking of proteins. The Examiner recommends rephrasing for clarity.
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 1-16 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over De Kort et al. (WO 2015/156672 A1, cited in the IDS), hereinafter De Kort.
De Kort discloses the invention of a liquid composition comprising crosslinked micellar casein, wherein the composition is preferably heat-treated by heat sterilization or pasteurization (Abstract; Claim 1). De Kort relates that casein micelles in milk can be cross-linked using transglutaminase (TG) treatment in order to improve the heat stability of milk (p. 4, lines 23-25).
Regarding Claim 1 step i), De Kort teaches preparing a micellar casein solution having 7 to 15 g micellar casein per 100 ml (p. 22, lines 9-14). De Kort teaches a liquid composition comprising protein between 11 and 25 g per 100 ml, wherein the protein comprises at least 30 wt.%, preferably at least 50 wt.%, more preferably at least 70 wt.% , most preferred at least 85wt% micellar casein based on total protein (Claim 2; Table 1). The micellar casein solution is preferably prepared by filtration of milk protein in order to remove the whey fraction, according to standard procedures known in the art (p. 22, lines 9-14). Because De Kort teaches removal of the whey, De Kort reads on the claimed feature of the whey protein amounting to less than or equal to 20% by mass of total nitrogenous matter (TNM).
Regarding the fat content in step i), De Kort teaches protein sources including micellar casein isolate (MCI), milk protein isolate (MPI) comprising about 80% micellar casein of the total protein content, milk protein concentrate (MPC) which is usually prepared by ultra filtration that also contains about 80 % micellar casein, skimmed milk (defatted milk), and fresh or pasteurized milk (p. 18, lines 6-12). As such, defatted milk, i.e. negligible amount of fat, is a suitable protein source according to De Kort and the composition does not require fat. Furthermore, De Kort teaches a nutritional composition with a fat content between 6-25 wt.% based on total weight of the composition, which overlaps with the claimed fat content (p. 23, lines 17-23).
Regarding Claim 1 step ii), De Kort teaches incubating the protein solution with TG preferably at a final concentration between 5-100 Units/g protein (p. 22, lines 27-28). A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05.
Regarding Claim 1 step iii), De Kort relates that TG catalyzes an acyl-transfer reaction which promotes the crosslinking process (p. 15, lines 4-17). De Kort teaches an embodiment relating a powder comprising transglutaminase-treated cross-linked micellar casein (TGMC) wherein the cross-linked micellar casein is present in at least 30 wt.% based on the dry weight of the powder (p. 17, lines 1-8). In one embodiment, the powder does not comprise any non-cross-linked micellar casein, and in another, the powder comprises between 90-100 wt.% cross-linked micellar casein based on the total weight of the powder (p. 17, lines 1-8).
Regarding Claim 1 steps iv)-vi), De Kort teaches inactivation of the enzyme, and the composition with cross-linked micellar casein may conveniently be concentrated or dried for further use (p. 23, lines 12-15; p. 24, lines 12-14).
Regarding Claim 2, De Kort teaches a pH between 6-8 for the liquid composition comprising the casein, and then subjected to TG treatment (Claim 12).
Regarding Claim 3 and 27, De Kort teaches subjecting said composition to transglutaminase treatment, preferably at a temperature between 37 and 50 °C (Claim 12).
Regarding Claim 4, De Kort expressly teaches the incubation time of 3 h prior to inactivation of the enzyme (p. 24, lines 7-15).
Regarding Claim 5, De Kort teaches that the liquid composition comprising cross-linked micellar casein is preferably heat-treated by heat sterilization or pasteurization (Claim 1). Additionally, De Kort expressly teaches pasteurized milk as the protein source (p. 18, lines 6-11).
Regarding Claim 6, De Kort teaches wherein the cross-linked micellar casein composition is dried to form a powder, preferably by spray drying (Claim 15).
Regarding Claim 7, De Kort teaches an embodiment relating a powder comprising transglutaminase-treated cross-linked micellar casein (TGMC) wherein the cross-linked micellar casein is present in at least 30 wt.% based on the dry weight of the powder, which overlaps with the claimed range (p. 17, lines 1-6).
Regarding Claims 8 and 10, 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 (p. 17, lines 1-8). Herein the TGMC reads on the total nitrogenous matter.
Regarding Claim 9, De Kort teaches skimmed milk, and also teaches that fat and carbohydrates may be added in order to arrive at a low-viscous, high-protein and high-caloric composition indicating that fat is not necessary (p. 17, lines 11-19; p. 18, lines 6-12). Furthermore, De Kort teaches a nutritional composition with a fat content between 6-25 wt.% based on total weight of the composition, which overlaps with the claimed fat content (p. 23, lines 17-23).
Regarding Claim 11, De Kort teaches its composition comprises at least 30 wt.% micellar casein, most preferably between 60-95% crosslinked micellar casein, based on the total weight of the powder (Claim 17; p. 17, lines 1-6).
Regarding Claims 12-13, 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 (p. 17, lines 1-8). 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). A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05.
Regarding Claims 14 and 16, De Kort teaches enzyme inactivation by heating to at least 65 °C for at least 5 minutes, and spray drying (p. 16, lines 19-31). 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 De Kort and the instant invention teaches the same methods and compositions, De Kort would necessarily have low quantity of cross-linked caseins having molecular weights greater than 400,000 Daltons.
Regarding Claim 15, De Kort teaches powder composition which are suitable for energy dense nutritional compositions (p. 4, lines 12-15; Claim 17).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over De Kort, as applied to Claim 1 above, and in view of Rudie et al. (WO 00/32055, cited in the IDS; Of record), hereinafter Rudie.
Regarding Claim 24, De Kort does not teach the claimed dose of less than or equal to 1 unit per gram of total nitrogenous matter (TNM).
Rudie is in the same field and teaches the preparation of an opacifying agent suitable for beverages, such as milk, comprising crosslinked caseinate (Abstract). Rudie teaches its method The method utilizes transglutaminase for crosslinking at about 1 Unit to about 20 Units per gram of caseinate or whey protein (Claim 4).
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 Rudie to De Kort and optimize the amount of TG enzyme for crosslinking micellar casein. One of ordinary skill in the art would find it obvious to adjust the enzyme unit per weight of micellar casein to crosslink 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.
Claims 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over De Kort, as applied to Claim 1 above, and in view of Boursier et al. (US 2015/0237885 A1), hereinafter Boursier.
Regarding Claims 25-26, De Kort 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].
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 to De Kort and prepare intermicellar cross-linked casein starting at a particle size larger than 200 nm, and having d-50 less than 500 µm and a volume mean diameter D4,3, between 10 µm and 500 µm [0208]. One would then optimize 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.
Conclusion
No claims are allowed.
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
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792