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 .
The amendment filed June 9, 2025 is acknowledged. Claims 76-98 are pending in the application. Claims 1-75 have been cancelled. Claim 94 is withdrawn from consideration.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 76-82, 85-93, and 95-98 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pandya et al. US 20170273328 (hereinafter “Pandya”).
With respect to claim 76, Pandya teaches food products (paragraphs [0002], [0035], [0042], [0228], [0229], and [0253]).
Regarding the limitation of comprising a coagulated colloid, wherein the coagulated colloid comprises α casein protein and κ casein protein associated in a micellar form, wherein at least one of the α (alpha) casein protein and κ (kappa) casein protein is recombinantly produced, and wherein the micellar form does not contain β (beta) casein protein as recited in claim 76, Pandya teaches the food product includes casein milk proteins. At least two types of casein proteins are in a micellar formation, and the casein proteins are recombinantly produced. The casein proteins are selected from κ-casein, α-S1-casein, α-S2-casein, and β-casein (paragraphs [0035], [0057], [0068], [0114], [0129], [0193], [0194], [0230], and [0253]). Thus, an edible composition comprising recombinant α casein protein and recombinant κ casein protein in a micellar form that does not contain β casein as presently claimed can be “at once envisaged” from the disclosure of Pandya. See MPEP 2131.02
With respect to claim 77, Pandya is relied upon for the teaching of the composition of claim 76 as addressed above.
Regarding the limitation of wherein the recombinantly produced casein is produced from a bacterial host cell as recited in claim 77, Pandya teaches the casein proteins are produced from a bacterial host cell (paragraphs [0035], [0191], and [0193]).
With respect to claim 78, Pandya is relied upon for the teaching of the composition of claim 77 as addressed above.
Regarding the limitation of wherein the bacterial host cell is selected from the group consisting of Lactococci sp., Lactococcus lactis, Bacillus subtilis, Bacillus amyloliquefaciens, Bacillus licheniformis and Bacillus megaterium, Brevibacillus choshinensis, Mycobacterium smegmatis, Rhodococcus erythropolis and Corynebacterium glutamicum, Lactobacilli sp., Lactobacillus fermentum, Lactobacillus casei, Lactobacillus acidophilus, Lactobacillus plantarum, Synechocystis sp. 6803 and E.coli as recited in claim 78, Pandya teaches the bacterial host cell is E. coli (paragraphs [0035], [0191], [0193], and [0317]).
With respect to claim 79, Pandya is relied upon for the teaching of the composition of claim 76 as addressed above.
Regarding the limitation of wherein the α casein protein completely lacks or is substantially reduced in post-translational modification as compared to animal-derived α casein as recited in claim 79, Pandya teaches the recombinant α casein protein lacks glycosylation and/or expresses the same phosphate groups as compared to animal-derived casein protein (paragraphs [0026], [0110], and [0194]).
With respect to claim 80, Pandya is relied upon for the teaching of the composition of claim 76 as addressed above.
Regarding the limitation of wherein the α casein protein completely lacks or is substantially reduced in phosphorylation as compared to animal-derived α casein as recited in claim 80, Pandya teaches the recombinant α casein protein expresses the same phosphate groups as compared to animal-derived casein protein (paragraph [0110]).
With respect to claim 81, Pandya is relied upon for the teaching of the composition of claim 76 as addressed above.
Regarding the limitation of wherein the κ casein protein completely lacks or is substantially reduced in post-translational modification as compared to animal-derived κ casein as recited in claim 81, Pandya teaches the recombinant κ casein protein lacks glycosylation and/or expresses the same phosphate groups as compared to animal-derived casein protein (paragraphs [0026], [0110], and [0194]).
With respect to claim 82, Pandya is relied upon for the teaching of the composition of claim 81 as addressed above.
Regarding the limitation of wherein the κ casein protein completely lacks or is substantially reduced in glycosylation, phosphorylation or both glycosylation and phosphorylation as compared to animal-derived κ casein as recited in claim 82, Pandya teaches the recombinant κ casein protein lacks glycosylation and/or expresses the same phosphate groups as compared to animal-derived casein protein (paragraphs [0026], [0110], and [0194]).
With respect to claim 85, Pandya is relied upon for the teaching of the composition of claim 76 as addressed above.
Regarding the limitation of wherein the α casein protein is αS1 or αS2 as recited in claim 85, Pandya teaches the α-casein protein is α-S1-casein or α-S2-casein (paragraphs [0035], [0057], [0114], [0125]-[0128], [0194], and [0230]).
With respect to claim 86, Pandya is relied upon for the teaching of the composition of claim 76 as addressed above.
Regarding the limitation of wherein the α casein protein has an amino acid sequence comprising one of SEQ ID NO. 1-26 or a variant thereof with at least 80% sequence homology as recited in claim 86, Pandya teaches the α-casein protein has an amino acid sequence of SEQ ID NO. 1 (variants: No.48-99.4%, No. 52-86.5%, and No. 70-87.6% homology), 2 (variants: No.48-99.3%, No. 52-86.0%, and No. 70-86.8% homology), 3 (variants: No.48-88.8%, No. 52-96.4%, and No. 70-99.5% homology), 4 (variants: No.48-88.1%, No. 52-96.6%, and No. 70-99.5% homology), 5 (variants: No. 48-87.6%, No. 52-97.0%, and No. 70-97.1% homology), 6 (variants: No.48-86.8%, No. 52-97.2%, and No. 70-96.9% homology), 7 (variants: No.48-94.6%, No. 52-83.9%, and No. 70-85.1% homology), 8 (variants: No.48-94.2%, No. 52-83.3%, and No. 70-84.1% homology), 9 (No. 57), 9 (variants: No. 54-99.5% and No. 56-98.3% homology), 10 (No. 57), 10 (variants: No. 54-99.4% and No. 56-98.1% homology), 11 (variant: No. 50-94.9% homology), 12 (variant: No. 50-94.6% homology), 13 (variant: No. 61-99.6% homology), 14 (variant: No. 61-99.6% homology), 15 (variants: No.78-99.1%, No. 80-87.5%, and No. 88-88.3% homology), 16 (variants: No.78-99.1%, No. 80-86.6%, and No. 88-87.4% homology), 17 (No. 88), 17 (variants: No.78-85.4% and No. 80-98.4% homology), 18 (No. 88), 18 (variants: No.78-84.5% and No. 80-98.3% homology), 19 (No. 80), 19 (variants: No.78-84.3% and No. 88-98% homology), 20 (No. 80), 20 (variants: No.78-83.3% and No. 88-97.8% homology), 21 (variants: No.78-94.2%, No. 80-89.1%, and No. 88-89.9% homology), and 22 (variants: No.78-93.8%, No. 80-88.4%, and No. 88-89.2% homology) (paragraphs [0125]-[0128] and [0174]; and P67-P75, P79-P80, P84-P86, and P89-P90).
With respect to claim 87, Pandya is relied upon for the teaching of the composition of claim 76 as addressed above.
Regarding the limitation of wherein the κ casein protein has an amino acid sequence comprising one of SEQ ID NO. 27-40 or a variant thereof with at least 80% sequence homology as recited in claim 87, Pandya teaches the κ-casein protein has an amino acid sequence of SEQ ID NO. 27 (variants: No.1-98.6%, No. 3-84.5%, and No. 15-83.4% homology), 28 (variants: No.1-98.4%, No. 3-82.7%, and No. 15-81.5% homology), 29 (No. 15), 29 (variants: No.1-82% and No. 3-96.8% homology), 30 (No. 15), 30 (variants: No.1-80% and No. 3-96.5% homology) or 31 (No. 3), 31 (variants: No.1-83.1% and No. 15-96.7% homology), 32 (No. 3), 32 (variants: No.1-81.2% and No. 15-96.3% homology), 33 (variants: No.1-93%, No. 3-87.1%, and No. 15-85.8% homology) 34 (variants: No.1-92.2%, No. 3-85.6%, and No. 15-84.2% homology), 39 (No. 7), and 40 (No.7) (paragraphs [0123]-[0124 and [0174]]; and P40-P41, P43-P44, and P47-P48).
With respect to claim 88, Pandya is relied upon for the teaching of the composition of claim 76 as addressed above.
Regarding the limitation of further comprising at least one salt selected from the group consisting of a calcium salt, a citrate salt and a phosphate salt as recited in claim 88, Pandya teaches the product further includes one or more of a calcium salt, a phosphate salt, and a citrate salt (paragraphs [0129] and [0165]).
With respect to claim 89, Pandya is relied upon for the teaching of the composition of claim 76 as addressed above.
Regarding the limitation of wherein the coagulated colloid is comprised in a dairy replacement product, a cheese, a curd, a renneted curd, or a yogurt as recited in claim 89, Pandya teaches the food product containing the casein proteins may be a dairy substitute, cheese, yogurt, or curd (paragraphs [0002], [0035], [0042], and [0228]-[0230]).
With respect to claim 90, Pandya is relied upon for the teaching of the composition of claim 76 as addressed above.
Regarding the limitation of wherein the edible composition is a cheese and wherein the cheese has one or more of (a) a fat content more than 0% to about 50%, (b) a fat derived from a plant-based source or (c) a sugar derived from a plant-based source as recited in claim 90, Pandya teaches the food product is a cheese and may comprise plant-derived lipids, about 0 weight % to about 45 weight % of one or more lipids, and sweetening agent(s) from plant sources (paragraphs [0002], [0008], [0013], [0035], [0042], [0064], [0148]-[0149], [0156], [0228], [0229], [0234], and [0253]).
With respect to claim 91, Pandya is relied upon for the teaching of the composition of claim 76 as addressed above.
Regarding the limitation of wherein the edible composition is a cheese and wherein the cheese is capable of melting and browning when heated as recited in claim 91, Pandya teaches the food product is a cheese (paragraphs [0002], [0035], [0042], [0228], [0229], and [0253]). Absent any clear and convincing evidence to the contrary, the characteristic of the cheese is capable of melting and browning when heated would naturally occur from said cheese product since Pandya positively recites the claimed combination of ingredients as demonstrated above in claim 76, Pandya teaches the food product retains its functional characteristics (paragraphs [0040]-[0041]), and this characteristic is an intended result of the claimed composition. Additionally, Applicant is reminded that it has been held that the recitation that an element is “capable of” performing a function is not a positive limitation but only requires the ability to so perform. It does not constitute a limitation in any patentable sense. In re Hutchison, 69 USPQ 138. Further, it is noted that there is no structural difference between the composition of claim 91 and the composition of Pandya. Applicant is reminded the broadest reasonable interpretation of a system (or a product) claim having structure that performs a function, which only needs to occur if a condition precedent is met, requires structure for performing the function should the condition occur. The claimed structure must be present in the system regardless of whether the condition is met and the function is actually performed. See MPEP 2111.04.
With respect to claim 92, Pandya is relied upon for the teaching of the composition of claim 76 as addressed above.
Regarding the limitation of wherein the edible composition is a cheese selected from the group consisting of pasta-filata cheese, paneer, cream cheese, cottage cheese, an aged cheese and a renneted cheese as recited in claim 92, Pandya teaches the food product is a cheese such as cottage cheese, cream cheese, mozzarella, Havarti, Munster, Swiss, Jarlsberg, cheddar, brie, and camembert (paragraphs [0228], [0229], and [0253]).
With respect to claim 93, Pandya is relied upon for the teaching of the composition of claim 76 as addressed above.
Regarding the limitation of wherein the edible composition is a cheese and wherein the texture or hardness of the cheese is comparable to an animal-derived dairy cheese as recited in claim 93, Pandya teaches the product is a cheese and has identical or similar sensory characteristics to traditional dairy-based products such as mouthfeel and texture (paragraphs [0007], [0040]-[0042], [0108], [0228], [0229], and [0253]).
With respect to claim 95, Pandya teaches a milk substitute product (paragraphs [0002], [0035], [0042], and [0228]).
Regarding the limitation of comprising a micellar form, wherein the micellar form comprises a recombinant α casein protein, a recombinant κ casein protein and at least one salt, wherein the micellar form does not include β casein protein as recited in claim 95, Pandya teaches the milk substitute product includes casein milk proteins and at least one salt. At least two types of casein proteins are in a micellar formation, and the casein proteins are recombinantly produced. The casein proteins are selected from κ-casein, α-S1-casein, α-S2-casein, and β-casein (paragraphs [0035], [0057], [0068], [0114], [0129], [0165], [0193], [0194], and [0230]). Thus, a milk substitute comprising recombinant α casein protein and recombinant κ casein protein in a micellar form that does not contain β casein as presently claimed can be “at once envisaged” from the disclosure of Pandya. See MPEP 2131.02
With respect to claim 96, Pandya is relied upon for the teaching of the composition of claim 95 as addressed above.
Regarding the limitation of wherein the α casein protein, κ casein protein or a combination thereof completely lack or are substantially reduced in post-translational modification as recited in claim 96, Pandya teaches the recombinant κ casein protein and the recombinant α casein protein lack glycosylation and/or express the same phosphate groups as compared to animal-derived casein protein (paragraphs [0026], [0110], and [0194]).
With respect to claim 97, Pandya is relied upon for the teaching of the composition of claim 95 as addressed above.
Regarding the limitation of wherein (a) the α casein protein completely lacks or is substantially reduced in phosphorylation as compared to animal-derived α casein, (b) the κ casein protein completely lacks or is substantially reduced in glycosylation as compared to an animal-derived κ casein, (c) the κ casein protein completely lacks or is substantially reduced in phosphorylation as compared to an animal-derived κ casein or (d) any of (a), (b), and (c) as recited in claim 97, Pandya teaches the recombinant κ casein protein and the recombinant α casein protein lack glycosylation and/or express the same phosphate groups as compared to animal-derived casein protein (paragraphs [0026], [0110], and [0194]).
With respect to claim 98, Pandya teaches a yogurt composition (paragraphs [0002], [0035], [0042], and [0229]).
Regarding the limitation of formed from the liquid colloid of claim 95 as recited in claim 98, Pandya teaches a liquid colloid (milk substitute product) as addressed above in claim 95, and the milk substitute product can be incorporated into various food applications including yogurt (paragraphs [0228]-[0229]).
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 83 and 84 are rejected under 35 U.S.C. 103 as being unpatentable over Pandya et al. US 20170273328 (hereinafter “Pandya”) as applied to claim 76 above.
With respect to claim 83, Pandya is relied upon for the teaching of the composition of claim 76 as addressed above.
Regarding the limitation of wherein the ratio of α casein protein to κ casein protein is from 1:1 to 15:1 as recited in claim 83, Pandya teaches the casein composition comprises about 12-15 g/L of α-S1-casein, about 3-4 g/L of α-S2-casein, and about 2-4 g/L of κ-casein, which is equivalent to a ratio of α-S1-casein : κ-casein of 3-7.5 : 1 (calculated from 12-15 g/L / 2-4 g/L), a ratio of α-S2-casein : κ-casein of 0.75-2 : 1 (calculated from 3-4 g/L / 2-4 g/L), and a ratio of (α-S1-casein + α-S2-casein) : κ-casein of 3.75-9 : 1 (calculated from [12-15 g/L + 3-4 g/L] / 2-4 g/L) (paragraph [0230]). The ranges of Pandya overlap with the presently claimed range. As set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
With respect to claim 84, Pandya is relied upon for the teaching of the composition of claim 76 as addressed above.
Regarding the limitation of wherein the ratio of α casein protein to κ casein protein is from 1:1 to 5:1 as recited in claim 84, Pandya teaches the casein composition comprises about 12-15 g/L of α-S1-casein, about 3-4 g/L of α-S2-casein, and about 2-4 g/L of κ-casein, which is equivalent to a ratio of α-S1-casein : κ-casein of 3-7.5 : 1 (calculated from 12-15 g/L / 2-4 g/L), a ratio of α-S2-casein : κ-casein of 0.75-2 : 1 (calculated from 3-4 g/L / 2-4 g/L), and a ratio of α-S1-casein and α-S2-casein : κ-casein of 3.75-9 : 1 (calculated from [12-15 g/L + 3-4 g/L] / 2-4 g/L) (paragraph [0230]). The ranges of Pandya overlap with the presently claimed range. As set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Response to Arguments
Applicant’s remarks filed June 9, 2025 are acknowledged.
Due to the amendments to the claims, the claim objections as well as the 35 USC 112 rejection in the previous Office Action have been withdrawn (P6-P8).
Applicant’s arguments have been fully considered, but they are unpersuasive.
Applicant respectfully submits that Pandya does not disclose a micellar form comprising α casein and κ casein in the absence of β casein. Pandya's disclosure is focused primarily on compositions comprising κ casein and β casein. Disclosing micelles comprising β casein and κ casein and listing α casein as a potential additional composition in a composition does not amount to a disclosure of the specifically claimed composition that requires the combination of α casein and κ casein in a micellar form while simultaneously excluding β casein in the micellar form. Thus, Applicant respectfully disagrees with the Examiner's supposition that a micellar form that comprises α casein and κ casein in the absence of β casein can be "at once envisaged" from Pandya, as this fails to address the proper scope of the claims at issue. Based on the state of the art and the disclosures of Pandya, a person of ordinary skill in the art (POSITA) would not have a reasonable expectation of success in producing a micellar form comprising α casein and κ casein without β casein. Casein proteins are not functionally interchangeable. The Office Action appears to operate under a flawed premise that α, β, and κ caseins are functionally interchangeable building blocks. This contradicts established dairy science. These proteins possess distinct structures, and functions crucial for micelle assembly and properties. Because of these fundamental differences, a POSITA would not expect that simply substituting α-casein for the β-casein in Pandya's micelles comprising κ casein and β casein, or omitting β casein entirely from a system relying on α casein and κ casein, would result in a functional micellar structure capable of coagulation into a desirable edible product. Such modification would be expected to fundamentally alter micelle formation, stability, and coagulation in unpredictable ways. In view of the state of the art in dairy science regarding the function of casein proteins and the teachings of Pandya, a POSITA would not be motivated to combine α casein and κ casein without β casein to form micelles, and would not have a reasonable expectation of success in doing so. There is no teaching or suggestion in Pandya, nor was there motivation in the art at the time of filing, to exclude the structurally-significant β casein and specifically combine only α casein and κ casein to form a functional, coagulable micelle for edible products. Pandya's specific selection of and focus on combining κ casein with β casein to form micelles suggests that this combination was considered important for its goals and implicitly argues against interchangeability of the casein proteins. Pandya provides no reason or motivation to pursue combining α casein and κ casein without β casein to form micelles, nor any guidance that such a combination would work. A POSITA would not have had a reasonable expectation that forming stable, coagulable micelles using only α casein and κ casein would be successful based on the state of the art and the teachings of Pandya (P8-P11).
Examiner disagrees. As addressed above, Pandya teaches compositions that are substantially similar to that as presently claimed. Although Pandya teaches a composition comprising κ casein and β casein in one embodiment, Pandya is not limited to this embodiment since the reference also teaches a composition comprising at least two types of casein proteins that are in a micellar formation, and casein proteins are selected from κ-casein, α-S1-casein, α-S2-casein, and β-casein (paragraphs [0035], [0057], [0068], [0114], [0129], [0193], [0194], [0230], and [0253]). Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). Furthermore, "[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).
Additionally, an edible composition comprising α casein protein and κ casein protein in a micellar form that does not contain β casein as presently claimed can be “at once envisaged” from the disclosure of Pandya since Pandya teaches a composition comprising at least two types of casein proteins that are in a micellar formation, and the casein proteins are selected from κ-casein, α-S1-casein, α-S2-casein, and β-casein (paragraphs [0035], [0057], [0068], [0114], [0129], [0193], [0194], [0230], and [0253]), and it is within the ambit of one of ordinary skill in the art to select α casein protein and κ casein and arrive at the presently claimed invention. See MPEP 2131.02. Applicant is reminded that a reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination." Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015) (quoting In re Petering, 301 F.2d 676, 681(CCPA 1962)). In Kennametal, the challenged claim was to a cutting tool requiring a ruthenium binding agent with a physical vapor deposition (PVD) coating. The reference described all the elements of the claimed coated cutting tool but did not explicitly disclose the specific combination of ruthenium binding agent with a PVD coating. However, the reference disclosed that ruthenium was one of five specified binding agents and PVD was one of three suitable coating techniques. The Federal Circuit stated that the reference’s "express ‘contemplat[ion]’ of PVD coatings provided sufficient evidence that a reasonable mind could find that a person of skill in the art… would immediately envisage applying a PVD coating. Thus, substantial evidence supports the Board's conclusion that [the reference] effectively teaches 15 combinations, of which one anticipates pending claim 1. Though it is true that there is no evidence in [the reference] of ‘actual performance’ of combining the ruthenium binder and PVD coatings, this is not required." Kennametal, 780 F.3d at 1383, 114 USPQ2d at 1255 (citations omitted).
Applicant argues the Examples of the specification demonstrate the unexpected result that micelles can successfully be formed using α casein and κ casein in the absence of β casein. These unexpected results are sufficient to rebut any prima facie case of obviousness. These results are surprising and unexpected, as the state of the art and the teachings of Pandya do not teach or provide an expectation of success in combining α and κ casein without β casein to produce micelles. Pandya provides no working examples demonstrating the formation of a colloid comprising casein micelles of α and κ casein without β casein. All of the Examples in Pandya that construct dairy compositions are performed with "dry food-grade purified casein" (Pandya paragraph [0290]) or "powdered micellar casein protein" (Pandya paragraph [0362]), which generally refer to mixtures of all caseins found in milk (i.e., including β casein along with α and κ caseins). In short, Pandya provides no teaching or suggestion that would provide a POSITA with an expectation of success in combining α and κ casein without β casein to produce micelles. Taken together, the results in the specification demonstrate the surprising and unexpected result that α and κ casein, in the absence of β casein, can successfully be used to form micelles capable of forming coagulated colloids (Claim 76), liquid colloids (Claim 95), and products derived therefrom. These results are sufficient to rebut any prima facie case of obviousness (P11-P13).
Examiner disagrees. The features described by Applicant are indeed expected in view of Pandya. As previously addressed, Pandya teaches a composition comprising two types of casein proteins, such as α casein and κ casein, that are in a micellar formation (paragraphs [0035], [0057], [0068], [0114], [0129], [0193], [0194], [0230], and [0253]). Although Pandya teaches dry compositions in some embodiments, Pandya is not limited to these embodiments since Pandya also teaches products that can be used as milk substitutes (paragraphs [0002], [0035], [0042], and [0228]-[0230]). Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). Additionally, any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (differences in sedative and anticholinergic effects between prior art and claimed antidepressants were not unexpected). In other words, the unexpectedness must be sufficient “to secure the validity of the claims in suit.” Syntex (U.S.A.) LLC v. Apotex, Inc., 407 F.3d 1371, 1381 (Fed. Cir. 2005) and MPEP 716.02.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/T.L.M/Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793
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