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 September 19, 2025 is acknowledged. Claims 1-30 are pending in the application.
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 1-30 are rejected under 35 U.S.C. 103 as being unpatentable over Anchel WO 2016077457 (hereinafter “Anchel”) in view of Rodriguez US 20150313269 (hereinafter “Rodriguez”).
With respect to claim 1, Anchel teaches a liquid egg replacement composition (paragraphs [0018], [0031], [0033], [0034], [0107], [0133], [0135], [0136], and [0145]).
Regarding the limitation of comprising (a) one or more recombinant egg-white proteins comprising at least recombinant ovalbumin (rOVA) as recited in claim 1, Anchel teaches the composition comprises at least one recombinant egg-white protein including recombinant ovalbumin (paragraphs [0006], [0007], [0010], [0015], [0081], [0082], [0088], and [0095]).
Regarding the limitation of comprising (b) one or more gelation agents and/or one or more thickening agents as recited in claim 1, Anchel teaches the composition comprises one or more additives including binding agent, emulsifier, and thickener (paragraphs [0083], [0146], [0149], [0152], and [0155]).
Regarding the limitation of comprising (c) a lipid component at a weight percent to the composition from about 2% to about 15% on a w/w or w/v basis as recited in claim 1, Anchel teaches the composition comprises less than 10% fat and overlaps with the presently claimed range (paragraphs [0099] and [0146]). 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).
Regarding the limitation of comprising (d) lecithin at a weight percent to the composition of from about 0.1% to about 1% on a w/w or w/v basis as recited in claim 1, Anchel teaches the composition comprises one or more additives including lecithin (paragraph [0146]).
However, Anchel does not expressly disclose the lecithin content in the composition.
Rodriguez teaches a liquid egg-substitute composition comprising from about 0.01 to about 10% of lecithin (paragraphs [0009], [0039], [0048], and [0062]-[0063]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select any portions of the disclosed range, including the instantly claimed range of lecithin, from the range disclosed in the prior art with the expectation of successfully preparing an egg replacement composition. One of ordinary skill in the art would have been motivated to do so because Anchel and Rodriguez similarly teach liquid egg replacement compositions comprising lecithin, Anchel teaches the lecithin additives improve functional performance and/or physical characteristics (paragraph [0146]), and Rodriguez teaches the egg-substitute composition may have one or more qualities of natural eggs, such as emulsifying (paragraph [0108]). There would have been a reasonable expectation of success. "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages " In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.
Regarding the limitation of comprising (e) water as recited in claim 1, Anchel teaches the composition further comprises water (paragraphs [0015], [0080], and [0098]).
Regarding the limitation of wherein the weight percent of rOVA to the composition is at least 2% on a w/w basis as recited in claim 1, Anchel teaches the composition comprises at least one recombinant egg-white protein including recombinant ovalbumin, and the composition comprises approximately 10% recombinant egg-white protein (paragraphs [0006], [0007], [0010], [0015], [0079]-[0082], [0088], and [0095]).
With respect to claim 2, modified Anchel is relied upon for the teaching of the composition of claim 1 and addressed above.
Regarding the limitation of wherein the weight precent of rOVA to the composition is 8% to 11% on a w/w basis as recited in claim 2, Anchel teaches the composition comprises at least one recombinant egg-white protein including recombinant ovalbumin, and the composition comprises approximately 10% recombinant egg-white protein (paragraphs [0006], [0007], [0010], [0015], [0079]-[0082], [0088], and [0095]).
With respect to claim 3, modified Anchel is relied upon for the teaching of the composition of claim 1 and addressed above.
Regarding the limitation of wherein the weight percent of the lipid component to the composition is from about 2% to about 5% on a w/w or w/v basis as recited in claim 3, Anchel teaches the composition comprises less than 5% fat and encompasses the presently claimed range (paragraphs [0099] and [0146]). 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 4, modified Anchel is relied upon for the teaching of the composition of claim 1 and addressed above.
Regarding the limitation of wherein the composition lacks any animal-derived substances or any animal-derived components as recited in claim 4, modified Anchel teaches this limitation since Anchel teaches the composition is animal-free product (paragraphs [0004] and [0078]).
With respect to claim 5, modified Anchel is relied upon for the teaching of the composition of claim 1 and addressed above.
Regarding the limitation of wherein when the liquid whole egg substitute composition and a whole hen's egg are prepared as a scramble, the scrambled liquid whole egg substitute composition provides sensory attributes that are comparable to those of the scrambled whole hen's egg; wherein the sensory attributes comprise one or more of flavor, smell, color, chewiness, texture, fluffiness, springiness, hardness, adhesiveness, fracturability, cohesiveness, gumminess, softness, graininess, mouthfeel, appearance, likeability, bite, and aftertaste as recited in claim 5, the composition of modified Anchel would naturally display the claimed characteristics since modified Anchel teaches a composition that is substantially similar to the presently claimed composition as addressed above in claim 1, absent any clear and convincing evidence to the contrary. 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 6, modified Anchel is relied upon for the teaching of the composition of claim 1 and addressed above.
Regarding the limitation of wherein when the liquid whole egg substitute composition and a composition comprising a protein component consisting of proteins obtained from a plant are prepared as a scramble, the scrambled liquid whole egg substitute composition provides better sensory attributes than those of a scrambled composition comprising a protein component consisting of proteins obtained from a plant; wherein the sensory attributes comprise one or more of flavor, smell, color, chewiness, texture, fluffiness, springiness, hardness, adhesiveness, fracturability, cohesiveness, gumminess, softness, graininess, mouthfeel, appearance, likeability, bite, and aftertaste as recited in claim 6, the composition of modified Anchel would naturally display the claimed characteristics since modified Anchel teaches a composition that is substantially similar to the presently claimed composition as addressed above in claim 1, absent any clear and convincing evidence to the contrary. 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 7, modified Anchel is relied upon for the teaching of the composition of claim 1 and addressed above.
Regarding the limitation of wherein the rOVA is selected from the group consisting of duck OVA, ostrich OVA, quail OVA, and chicken OVA as recited in claim 7, modified Anchel teaches this limitation since Anchel teaches the recombinant ovalbumin may be derived from a bird selected from the group consisting of chicken, quail, duck, and ostrich (paragraphs [0015] and [0095]).
With respect to claim 8, modified Anchel is relied upon for the teaching of the composition of claim 1 and addressed above.
Regarding the limitation of wherein the glycosylation pattern of rOVA is different from a glycosylation pattern of chicken OVA as recited in claim 8, modified Anchel teaches this limitation since Anchel teaches the recombinant ovalbumin may have a glycosylation pattern different from the pattern of chicken ovalbumin (paragraphs [0010], [0089], and [0127]).
With respect to claim 9, modified Anchel is relied upon for the teaching of the composition of claim 1 and addressed above.
Regarding the limitation of, wherein the recombinant egg-white proteins further comprise a recombinant ovomucoid (rOVD) as recited in claim 9, modified Anchel teaches this limitation since Anchel teaches the composition further comprises recombinant ovomucoid (paragraphs [0006], [0007], [0010], and [0015]).
With respect to claim 10, modified Anchel is relied upon for the teaching of the composition of claim 1 and addressed above.
Regarding the limitation of wherein the composition comprises from about 25% to about 90% water as recited in claim 10, modified Anchel teaches this limitation since Anchel teaches the composition comprises up to 90% water (paragraphs [0015], [0079], [0098], and [0179]) and encompasses 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 11, modified Anchel is relied upon for the teaching of the composition of claim 1 and addressed above.
Regarding the limitation of wherein the amino acid profile of the recombinant egg-white proteins is closer to a whole hen's egg than the amino acid profile of a protein component consisting of proteins obtained from a plant as recited in claim 11, the composition of modified Anchel would naturally display the claimed characteristics since modified Anchel teaches a composition that is substantially similar to the presently claimed composition as addressed above in claim 1 and Anchel teaches liquid egg replacement compositions with at least 80% sequence identity comprising recombinant ovalbumin derived from a chicken (paragraphs [0015], [0067], and [0095]), absent any clear and convincing evidence to the contrary.
With respect to claim 12, modified Anchel is relied upon for the teaching of the composition of claim 1 and addressed above.
Regarding the limitation of wherein the recombinant egg-white protein comprises a fraction of cysteine, methionine, and/or lysine amino acids that is closer to the fraction in a whole hen's egg than the fraction in a protein component consisting of proteins obtained from a plant as recited in claim 12, the composition of modified Anchel would naturally display the claimed characteristics since modified Anchel teaches a composition that is substantially similar to the presently claimed composition as addressed above in claim 1 and Anchel teaches liquid egg replacement compositions comprising recombinant ovalbumin derived from a chicken and methionine, cysteine, and lysine residues (paragraphs [0012], [0015], [0062], [0090], and [0095]; and Fig. 1), absent any clear and convincing evidence to the contrary.
With respect to claim 13, modified Anchel is relied upon for the teaching of the composition of claim 1 and addressed above.
Regarding the limitation of further comprising a coloring agent as recited in claim 13, modified Anchel teaches this limitation since Anchel teaches the composition comprises coloring (paragraphs [0146]-[0147]).
With respect to claim 14, modified Anchel is relied upon for the teaching of the composition of claim 1 and addressed above.
Regarding the limitation of wherein the composition comprises at least 1% gelation agents as recited in claim 14, Anchel teaches the composition comprises one or more additives including binding agent, emulsifier, and thickener (paragraphs [0083], [0146], [0149], [0152], and [0155]).
However, Anchel does not expressly disclose the claimed quantity of at least 1%.
Rodriguez teaches a liquid egg-substitute composition comprising from about 0.5 to about 20% of gelling/thickening agent(s) (paragraphs [0009], [0039], [0048], [0078], and [0080]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select any portions of the disclosed range, including the instantly claimed range of gelation agents, from the ranges disclosed in the prior art reference with the expectation of successfully preparing an egg replacement composition. One of ordinary skill in the art would have been motivated to do so because Anchel and Rodriguez similarly teach liquid egg replacement compositions comprising gelling/thickening agents, Anchel teaches the concentration of the additives (gelation agent) may vary depending upon the formulation and can produce variations in consistency and palatability of the product (paragraphs [0178]-[0179]), and Rodriguez teaches the egg-substitute composition may have one or more qualities of natural eggs (paragraph [0108]). There would have been a reasonable expectation of success. "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages " In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.
With respect to claim 15, modified Anchel is relied upon for the teaching of the composition of claim 1 and addressed above.
Regarding the limitation of wherein the rOVA is recombinantly produced in a yeast host cell or in a fungal host cell as recited in claim 15, modified Anchel teaches this limitation since Anchel teaches the recombinant ovalbumin is produced by a yeast host cell or a fungi host cell (paragraphs [0025], [0127], [0167], and [0168]).
With respect to claim 16, modified Anchel is relied upon for the teaching of the composition of claim 15 and addressed above.
Regarding the limitation of wherein the yeast host cell is selected from a Pichica species and a Saccharomyces species, and the fungal host cell is selected from a Trichoderma species and an Aspergillus species as recited in claim 16, modified Anchel teaches this limitation since Anchel teaches the yeast host cell may be selected from the group consisting of Pichia spp. and Saccharomyces spp., and the fungi host cell may be selected from the group consisting of Aspergillus spp. And Trichoderma spp. (paragraphs [0025], [0127], and [0168]).
With respect to claim 17, modified Anchel is relied upon for the teaching of the composition of claim 1 and addressed above.
Regarding the limitation of wherein the composition does not comprise any natural egg white proteins or a natural egg white as recited in claim 17, modified Anchel teaches this limitation since Anchel teaches the composition does not comprise natural egg white or natural egg white proteins (paragraph [0099]).
With respect to claim 18, modified Anchel is relied upon for the teaching of the composition of claim 1 and addressed above.
Regarding the limitation of further comprising one or more plant proteins as recited in claim 18, modified Anchel teaches this limitation since Anchel teaches the composition may further comprise plant proteins (paragraphs [0025], [0075], [0077], [0127], and [0146]).
With respect to claim 19, Anchel teaches a liquid egg replacement composition (paragraphs [0018], [0031], [0033], [0034], [0107], [0133], [0135], [0136], and [0145]).
Regarding the limitation of comprising (a) recombinant egg-white proteins comprising at least recombinant ovalbumin (rOVA), wherein the rOVA is at a weight percent to the composition of at least 2% on a w/w or w/v basis as recited in claim 19, Anchel teaches the composition comprises at least one recombinant egg-white protein including recombinant ovalbumin. The composition comprises approximately 10% recombinant egg-white protein, and in one embodiment the protein comprises about 54% ovalbumin (about 5.4% recombinant ovalbumin in the composition) (paragraphs [0006], [0007], [0010], [0015], [0079]-[0082], [0088], [0095], and [0179]).
Regarding the limitation of comprising (b) a lipid component at a weight percentage from about 2% to about 5% on a w/w or w/v basis as recited in claim 19, Anchel teaches the composition comprises less than 5% fat and encompasses the presently claimed range (paragraphs [0099] and [0146]). 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).
Regarding the limitation of comprising (c) lecithin at a weight percent to the composition of from about 0.1% to about 1% on a w/w or w/v basis as recited in claim 19, Anchel teaches the composition comprises one or more additives including lecithin (paragraph [0146]).
However, Anchel does not expressly disclose the lecithin content in the composition.
Rodriguez teaches a liquid egg-substitute composition comprising from about 0.01 to about 10% of lecithin (paragraphs [0009], [0039], [0048], and [0062]-[0063]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select any portions of the disclosed range, including the instantly claimed range of lecithin, from the range disclosed in the prior art with the expectation of successfully preparing an egg replacement composition. One of ordinary skill in the art would have been motivated to do so because Anchel and Rodriguez similarly teach liquid egg replacement compositions comprising lecithin, Anchel teaches the lecithin additives improve functional performance and/or physical characteristics (paragraph [0146]), and Rodriguez teaches the egg-substitute composition may have one or more qualities of natural eggs, such as emulsifying (paragraph [0108]). There would have been a reasonable expectation of success. "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages " In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.
Regarding the limitation of comprising (d) water at a weight percent to the composition of from about 25% to about 90% on a w/w or w/v basis as recited in claim 19, Anchel teaches the composition comprises up to 90% water (paragraphs [0015], [0079], [0080], [0098], and [0179]) and encompasses 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).
Regarding the limitation comprising (e) gum at a weight percent to the composition of from about 0.5% to about 2% on a w/w or w/v basis as recited in claim 19, Anchel teaches the composition comprises one or more additives including gums (paragraphs [0083], [0146], [0149], and [0155]).
However, Anchel does not expressly disclose the claimed quantity of from about 0.5% to about 2% on a w/w or w/v basis.
Rodriguez teaches a liquid egg-substitute composition comprising from about 0.5 to about 20% of gum(s) (paragraphs [0009], [0039], [0048], [0078], and [0080]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select any portions of the disclosed range, including the instantly claimed range of gum, from the range disclosed in the prior art reference with the expectation of successfully preparing an egg replacement composition. One of ordinary skill in the art would have been motivated to do so because Anchel and Rodriguez similarly teach liquid egg replacement compositions comprising gum, Anchel teaches the concentration of the additives (gelation agent) may vary depending upon the formulation and can produce variations in consistency and palatability of the product (paragraphs [0178]-[0179]), and Rodriguez teaches the egg-substitute composition may have one or more qualities of natural eggs (paragraph [0108]). There would have been a reasonable expectation of success. "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages " In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.
Regarding the limitation of comprising (f) a salt at a weight percent to the composition of from about 0.1% to about 2% on a w/w or w/v basis as recited in claim 19, Anchel teaches the composition comprises one or more additives including salt (paragraphs [0015], [0083], [0098], [0146], and [0150]).
Anchel does not expressly disclose the claimed quantity of salt.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the amount of salt present in the composition of Anchel through routine experimentation with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Anchel teaches the concentration of salt may vary depending upon the formulation and can produce variations in consistency and palatability of the product (paragraphs [0146] and [0178]-[0179]), and it is understood that, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. There would have been a reasonable expectation of success. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05 II).
Regarding the limitation of comprising (g) baking powder at a weight percent to the composition of from about 0.1% to about 1% on a w/w or w/v basis as recited in claim 19, Anchel teaches the composition may comprise additives such as sodium bicarbonate (paragraphs [0146] and [0148]).
However, Anchel does not expressly disclose the composition comprises from about 0.1% to about 1% of baking powder.
Rodriguez teaches a liquid egg-substitute composition comprising from 0 to about 20% of leavening agents such as sodium bicarbonate and baking powder (paragraphs [0009], [0039], [0048], and [0089]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, given the teachings of Rodriguez, to select baking powder based upon its suitability for its intended purpose in Anchel with the expectation of successfully preparing a functional egg replacement composition. One of ordinary skill in the art would have been motivated to do so because Anchel and Rodriguez similarly teach liquid egg replacement compositions comprising similar ingredients, Anchel teaches the additive is not limited to pH adjusters such as sodium bicarbonate (paragraphs [0146] and [0148]), Rodriguez recognizes the equivalence of sodium bicarbonate and baking powder in egg substitute compositions and teaches the sodium bicarbonate/baking powder may be used as additional leavening agents in the egg substitute composition (paragraphs [0089] and [0108]), and said combination would amount to the use of a known element for its intended use in a known environment to accomplish entirely expected results. There would have been a reasonable expectation of success with said modification. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. (“Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle.” Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) See also In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960) (selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious)) (MPEP 2144.07).
With respect to claim 20, modified Anchel is relied upon for the teaching of the composition of claim 19 and addressed above.
Regarding the limitation of further comprising a natural coloring or a synthetic coloring at a weight percent to the composition of from about 0.1 % to about 2 % on a w/w or w/v basis as recited in claim 20, Anchel teaches the composition comprises one or more additives including natural coloring or synthetic coloring (paragraphs [0083], [0146], and [0147]).
However, Anchel does not expressly disclose the claimed quantity of from about 0.1% to about 2%.
Rodriguez teaches a liquid egg-substitute composition comprising from about 0.1 to about 20% of natural and/or artificial coloring agents (paragraphs [0009], [0039], [0048], and [0091]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select any portions of the disclosed range, including the instantly claimed range of coloring, from the range disclosed in the prior art reference with the expectation of successfully preparing an egg replacement composition. One of ordinary skill in the art would have been motivated to do so because Anchel and Rodriguez similarly teach liquid egg replacement compositions comprising coloring, Anchel teaches the concentration of the additives may vary depending upon the formulation and can produce variations in appearance, consistency, and palatability of the product (paragraphs [0079], [0099], [0178]-[0179]), and Rodriguez teaches the egg-substitute composition may have one or more qualities of natural eggs (paragraph [0108]). There would have been a reasonable expectation of success. "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages " In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.
With respect to claim 21, modified Anchel is relied upon for the teaching of the composition of claim 19 and addressed above.
Regarding the limitation of further comprising a flavoring agent at a weight percent to the composition of from about 0.1% to about 5% on a w/w or w/v basis as recited in claim 21, Anchel teaches the composition comprises one or more additives including flavoring (paragraphs [0083] and [0146]).
However, modified Anchel does not expressly disclose the claimed quantity of from about 0.1% to about 5%.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the amount of flavoring present in the composition of modified Anchel through routine experimentation with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Anchel teaches the concentration of the additives may vary depending upon the formulation and can produce variations in consistency and palatability of the product (paragraphs [0178]-[0179]), and it is understood that, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. There would have been a reasonable expectation of success. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05 II).
With respect to claim 22, modified Anchel is relied upon for the teaching of the composition of claim 19 and addressed above.
Regarding the limitation of wherein: the amino acid profile of the recombinant egg-white proteins is closer to a whole hen's egg than the amino acid profile of a protein component consisting of proteins obtained from a plant; and/or the nutrition value provided by amino acids of the recombinant egg-white proteins is closer to a whole hen's egg than the nutrition value provided by amino acids of a protein component consisting of proteins obtained from a plant; and/or the recombinant egg-white protein comprises a fraction of cysteine, methionine, and/or lysine amino acids that is closer to the fraction in a whole hen's egg than the fraction in a protein component consisting of proteins obtained from a plant; and/or the recombinant egg-white protein comprises a larger fraction of cysteine, methionine, and/or lysine amino acids than the fraction in a composition comprising a protein component consisting of proteins obtained from a plant; and/or the recombinant egg-white protein comprises a fraction of cysteine and methionine amino acids closer to the fraction in a whole hen's egg than the fraction in a protein component consisting of proteins obtained from a plant as recited in claim 22, the composition would naturally display the claimed characteristics since Anchel, as shown above, teaches liquid egg replacement compositions comprising methionine, cysteine, and lysine residues (paragraphs [0012], [0062], and [0090]; and Fig. 1) and modified Anchel teaches egg replacement compositions that are substantially similar to the presently claimed composition, absent any clear and convincing evidence to the contrary.
With respect to claim 23, modified Anchel is relied upon for the teaching of the composition of claim 19 and addressed above.
Regarding the limitation of wherein when the liquid whole egg substitute composition and a whole hen's egg are prepared as a scramble, the scrambled liquid whole egg substitute composition provides sensory attributes that are comparable to those of the scrambled whole hen's egg; wherein the sensory attributes comprise one or more of flavor, smell, color, chewiness, texture, fluffiness, springiness, hardness, adhesiveness, fracturability, cohesiveness, gumminess, softness, graininess, mouthfeel, appearance, likeability, bite, or aftertaste as recited in claim 23, the composition of modified Anchel would naturally display the claimed characteristics since modified Anchel teaches a composition that is substantially similar to the presently claimed composition as addressed above in claim 19, absent any clear and convincing evidence to the contrary. 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 24, modified Anchel is relied upon for the teaching of the composition of claim 19 and addressed above.
Regarding the limitation of, wherein when the liquid whole egg substitute composition and a composition comprising a protein component consisting of proteins obtained from a plant are prepared as a scramble, the scrambled liquid whole egg substitute composition provides better sensory attributes than those of a scrambled composition comprising a protein component consisting of proteins obtained from a plant; wherein the sensory attributes comprise one or more of flavor, smell, color, chewiness, texture, fluffiness, springiness, hardness, adhesiveness, fracturability, cohesiveness, gumminess, softness, graininess, mouthfeel, appearance, likeability, bite, or aftertaste as recited in claim 24, the composition of modified Anchel would naturally display the claimed characteristics since modified Anchel teaches a composition that is substantially similar to the presently claimed composition as addressed above in claim 19, absent any clear and convincing evidence to the contrary. 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 25, Anchel teaches a liquid egg replacement composition (paragraphs [0018], [0031], [0033], [0034], [0107], [0133], [0135], [0136], and [0145]).
Regarding the limitation of comprising (a) recombinant egg-white proteins comprising at least recombinant ovalbumin (rOVA), wherein the rOVA is at a weight percent to the composition of 8% to 11% on a w/w or w/v basis as recited in claim 25, Anchel teaches the composition comprises at least one recombinant egg-white protein including recombinant ovalbumin, and the composition comprises approximately 10% recombinant egg-white protein (paragraphs [0006], [0007], [0010], [0015], [0079]-[0082], [0088], and [0095]).
Regarding the limitation of comprising (b) a lipid component at a weight percentage from about 2% to about 5% on a w/w or w/v basis as recited in claim 25, Anchel teaches the composition comprises less than 5% fat and encompasses the presently claimed range (paragraphs [0099] and [0146]). 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).
Regarding the limitation of comprising (c) lecithin at a weight percent to the composition of from about 0.1% to about 1% on a w/w or w/v basis as recited in claim 25, Anchel teaches the composition comprises one or more additives including lecithin (paragraph [0146]).
However, Anchel does not expressly disclose the lecithin content in the composition.
Rodriguez teaches a liquid egg-substitute composition comprising from about 0.01 to about 10% of lecithin (paragraphs [0009], [0039], [0048], and [0062]-[0063]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select any portions of the disclosed range, including the instantly claimed range of lecithin, from the range disclosed in the prior art with the expectation of successfully preparing an egg replacement composition. One of ordinary skill in the art would have been motivated to do so because Anchel and Rodriguez similarly teach liquid egg replacement compositions comprising lecithin, Anchel teaches the lecithin additives improve functional performance and/or physical characteristics (paragraph [0146]), and Rodriguez teaches the egg-substitute composition may have one or more qualities of natural eggs, such as emulsifying (paragraph [0108]). There would have been a reasonable expectation of success. "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages " In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.
Regarding the limitation of comprising (d) water at a weight percent to the composition of from about 25% to about 90% on a w/w or w/v basis as recited in claim 25, Anchel teaches the composition comprises up to 90% water (paragraphs [0015], [0079], [0080], [0098], and [0179]) and encompasses 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).
Regarding the limitation comprising (e) gum at a weight percent to the composition of from about 0.5% to about 1% on a w/w or w/v basis as recited in claim 25, Anchel teaches the composition comprises one or more additives including gums (paragraphs [0083], [0146], [0149], and [0155]).
However, Anchel does not expressly disclose the claimed quantity of from about 0.5% to about 1% on a w/w or w/v basis.
Rodriguez teaches a liquid egg-substitute composition comprising from about 0.5 to about 20% of gum(s) (paragraphs [0009], [0039], [0048], [0078], and [0080]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select any portions of the disclosed range, including the instantly claimed range of gum, from the range disclosed in the prior art reference with the expectation of successfully preparing an egg replacement composition. One of ordinary skill in the art would have been motivated to do so because Anchel and Rodriguez similarly teach liquid egg replacement compositions comprising gum, Anchel teaches the concentration of the additives (gelation agent) may vary depending upon the formulation and can produce variations in consistency and palatability of the product (paragraphs [0178]-[0179]), and Rodriguez teaches the egg-substitute composition may have one or more qualities of natural eggs (paragraph [0108]). There would have been a reasonable expectation of success. "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages " In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.
Regarding the limitation of comprising (f) a salt at a weight percent to the composition of from about 0.1% to about 1% on a w/w or w/v basis as recited in claim 25, Anchel teaches the composition comprises one or more additives including salt (paragraphs [0015], [0083], [0098], [0146], and [0150]).
Anchel does not expressly disclose the claimed quantity of salt.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the amount of salt present in the composition of Anchel through routine experimentation with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Anchel teaches the concentration of salt may vary depending upon the formulation and can produce variations in consistency and palatability of the product (paragraphs [0146] and [0178]-[0179]), and it is understood that, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. There would have been a reasonable expectation of success. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05 II).
Regarding the limitation of comprising (g) baking powder at a weight percent to the composition of from about 0.1% to about 1% on a w/w or w/v basis as recited in claim 25, Anchel teaches the composition may comprise additives such as sodium bicarbonate (paragraphs [0146] and [0148]).
However, Anchel does not expressly disclose the composition comprises from about 0.1% to about 1% of baking powder.
Rodriguez teaches a liquid egg-substitute composition comprising from 0 to about 20% of leavening agents such as sodium bicarbonate and baking powder (paragraphs [0009], [0039], [0048], and [0089]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, given the teachings of Rodriguez, to select baking powder based upon its suitability for its intended purpose in Anchel with the expectation of successfully preparing a functional egg replacement composition. One of ordinary skill in the art would have been motivated to do so because Anchel and Rodriguez similarly teach liquid egg replacement compositions comprising similar ingredients, Anchel teaches the additive is not limited to pH adjusters such as sodium bicarbonate (paragraphs [0146] and [0148]), Rodriguez recognizes the equivalence of sodium bicarbonate and baking powder in egg substitute compositions and teaches the sodium bicarbonate/baking powder may be used as additional leavening agents in the egg substitute composition (paragraphs [0089] and [0108]), and said combination would amount to the use of a known element for its intended use in a known environment to accomplish entirely expected results. There would have been a reasonable expectation of success with said modification. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. (“Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle.” Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) See also In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960) (selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious)) (MPEP 2144.07).
With respect to claim 26, modified Anchel is relied upon for the teaching of the composition of claim 25 and addressed above.
Regarding the limitation of further comprising a natural coloring or a synthetic coloring at a weight percent to the composition of from about 0.1 % to about 2 % on a w/w or w/v basis as recited in claim 26, Anchel teaches the composition comprises one or more additives including natural coloring or synthetic coloring (paragraphs [0083], [0146], and [0147]).
However, Anchel does not expressly disclose the claimed quantity of from about 0.1% to about 2%.
Rodriguez teaches a liquid egg-substitute composition comprising from about 0.1 to about 20% of natural and/or artificial coloring agents (paragraphs [0009], [0039], [0048], and [0091]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select any portions of the disclosed range, including the instantly claimed range of coloring, from the range disclosed in the prior art reference with the expectation of successfully preparing an egg replacement composition. One of ordinary skill in the art would have been motivated to do so because Anchel and Rodriguez similarly teach liquid egg replacement compositions comprising coloring, Anchel teaches the concentration of the additives may vary depending upon the formulation and can produce variations in appearance, consistency, and palatability of the product (paragraphs [0079], [0099], [0178]-[0179]), and Rodriguez teaches the egg-substitute composition may have one or more qualities of natural eggs (paragraph [0108]). There would have been a reasonable expectation of success. "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages " In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.
With respect to claim 27, modified Anchel is relied upon for the teaching of the composition of claim 25 and addressed above.
Regarding the limitation of further comprising a flavoring agent at a weight percent to the composition of from about 0.1% to about 5% on a w/w or w/v basis as recited in claim 27, Anchel teaches the composition comprises one or more additives including flavoring (paragraphs [0083] and [0146]).
However, modified Anchel does not expressly disclose the claimed quantity of from about 0.1% to about 5%.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the amount of flavoring present in the composition of modified Anchel through routine experimentation with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Anchel teaches the concentration of the additives may vary depending upon the formulation and can produce variations in consistency and palatability of the product (paragraphs [0178]-[0179]), and it is understood that, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. There would have been a reasonable expectation of success. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05 II).
With respect to claim 28, modified Anchel is relied upon for the teaching of the composition of claim 25 and addressed above.
Regarding the limitation of wherein: the amino acid profile of the recombinant egg-white proteins is closer to a whole hen's egg than the amino acid profile of a protein component consisting of proteins obtained from a plant; and/or the nutrition value provided by amino acids of the recombinant egg-white proteins is closer to a whole hen's egg than the nutrition value provided by amino acids of a protein component consisting of proteins obtained from a plant; and/or the recombinant egg-white protein comprises a fraction of cysteine, methionine, and/or lysine amino acids that is closer to the fraction in a whole hen's egg than the fraction in a protein component consisting of proteins obtained from a plant; and/or the recombinant egg-white protein comprises a larger fraction of cysteine, methionine, and/or lysine amino acids than the fraction in a composition comprising a protein component consisting of proteins obtained from a plant; and/or the recombinant egg-white protein comprises a fraction of cysteine and methionine amino acids closer to the fraction in a whole hen's egg than the fraction in a protein component consisting of proteins obtained from a plant as recited in claim 28, the composition would naturally display the claimed characteristics since Anchel, as shown above, teaches liquid egg replacement compositions comprising methionine, cysteine, and lysine residues (paragraphs [0012], [0062], and [0090]; and Fig. 1) and modified Anchel teaches egg replacement compositions that are substantially similar to the presently claimed composition, absent any clear and convincing evidence to the contrary.
With respect to claim 29, modified Anchel is relied upon for the teaching of the composition of claim 25 and addressed above.
Regarding the limitation of wherein when the liquid whole egg substitute composition and a whole hen's egg are prepared as a scramble, the scrambled liquid whole egg substitute composition provides sensory attributes that are comparable to those of the scrambled whole hen's egg; wherein the sensory attributes comprise one or more of flavor, smell, color, chewiness, texture, fluffiness, springiness, hardness, adhesiveness, fracturability, cohesiveness, gumminess, softness, graininess, mouthfeel, appearance, likeability, bite, or aftertaste as recited in claim 29, the composition of modified Anchel would naturally display the claimed characteristics since modified Anchel teaches a composition that is substantially similar to the presently claimed composition as addressed above in claim 25, absent any clear and convincing evidence to the contrary. 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 30, modified Anchel is relied upon for the teaching of the composition of claim 25 and addressed above.
Regarding the limitation of, wherein when the liquid whole egg substitute composition and a composition comprising a protein component consisting of proteins obtained from a plant are prepared as a scramble, the scrambled liquid whole egg substitute composition provides better sensory attributes than those of a scrambled composition comprising a protein component consisting of proteins obtained from a plant; wherein the sensory attributes comprise one or more of flavor, smell, color, chewiness, texture, fluffiness, springiness, hardness, adhesiveness, fracturability, cohesiveness, gumminess, softness, graininess, mouthfeel, appearance, likeability, bite, or aftertaste as recited in claim 30, the composition of modified Anchel would naturally display the claimed characteristics since modified Anchel teaches a composition that is substantially similar to the presently claimed composition as addressed above in claim 25, absent any clear and convincing evidence to the contrary. 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.
Response to Amendment
The Declaration under 37 CFR 1.132 filed March 7, 2024 is insufficient to overcome the rejection of claims 1-30 based upon Anchel in view of Rodriguez as set forth in the last Office action because of the following:
“In assessing the probative value of an expert opinion, the Examiner must consider:
1) the nature of the matter sought to be established,
2) the strength of any opposing evidence,
3) the interest of the expert in the outcome of the case, and
4) the presence or absence of factual support for the expert’s opinion.
Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 227 USPQ 657 (Fed. Cir. 1985), cert. denied, 475 U.S. 1017 (1986).”
It is noted that this Declaration was filed for application 18057134 which has been abandoned. Although there is some overlap between the claims in application 18057134 and the instant application, it is noted that the data presented in Table 1 of the Declaration is not commensurate in scope with the invention of claims 19-30 of the instant application (the oil content in Table 1 is greater than the lipid component quantity in the claimed invention; and salt and baking powder as presently claimed is not present in Table 1 of the Declaration).
Additionally, the Declaration was previously addressed for application 18057134 (see the Non-Final Rejection of April 11, 2024). Examiner’s position of the Declaration is maintained and has been provided below:
The Declaration was filed by Shayanti Minj. However, the Declarant is NOT listed as an inventor in the present application. Applicant is reminded in assessing the probative value of an expert opinion, the examiner must consider the nature of the matter sought to be established, the strength of any opposing evidence, the interest of the expert in the outcome of the case, and the presence or absence of factual support for the expert’s opinion. Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 227 USPQ 657 (Fed. Cir. 1985), cert. denied, 475 U.S. 1017 (1986). Where the objectivity of the declarant is an issue in the prosecution, the inventor must disclose the known relationships and affiliations of the declarants so that those interests can be considered in weighing the declarations. Ferring B.V. v. Barr Laboratories, Inc., 437 F.3d 1181, 78 U.S.P.Q.2d (BNA) 1161 (Fed. Cir. 2006).
The Declaration shows experimental data of scrambles made with liquid whole egg substitutes versus control scrambles made in the same manner with native egg. Testers compared the scrambles made with the liquid whole substitutes with the native whole egg scrambles in a sensory evaluation. The results were presented in Tables 1 and 2. The Declaration indicated that it is surprising that for the testers gave a higher sensory rating to the scrambles made with liquid whole egg substitutes that contained much less lipid than native egg, and it is further surprising that the testers rated the formula 1-4 scramble higher than the scramble made with the native egg, indicating that despite only containing about 6.8% lipid content, the liquid whole egg substitute formula 1-4 provided sensory characteristics that were at least equivalent to the native whole egg, and testers preferred the flavor/aftertaste and the mouthfeel of the egg substitute over native whole egg. Additionally, the experiments suggest that low lipid content can provide equivalent or superior sensory and texture characteristics to the liquid whole egg substitute relative to native egg and that the addition of baking powder is associated with the equivalent or improved sensory and texture characteristics of the liquid whole egg substitute formula.
It is Examiner’s position that unexpected results have not been demonstrated in this Declaration. Firstly, it is understood that the sensory attributes measured by the testers (ratings of their likeliness for the scramble made with native whole egg and the scramble made with liquid whole egg substitute) in Tables 1 and 2 are a matter of choice and is the subjective opinion of the person sampling the scramble See MPEP 2173.05(b). In Table 1, while in one instance the scramble of formula 1-4 (present invention) had a sensory rating of 7 (like moderately) which was better than the control (native whole egg) scramble rating of 6 (like slightly), another instance showed the scramble of formula 1-3, which is also of the present invention, having a score of 6 (like slightly) which was lower than the score of the control (native whole egg) scramble rating of 8 (like very much). In Table 2, scrambles prepared from formulas 2-1, 2-2, and 2-3 of the present invention have a firmness and springiness that are less than the scramble prepared from the native whole egg (control). Thus, the evidence of unexpected results is not commensurate in scope with the claimed invention. Applicant is reminded the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support. See MPEP 716.02(d). Further, the Declaration fails to demonstrate the criticality of the claimed ranges in Tables 1 and 2. Applicant is also reminded to establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960).
The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) (Mere conclusions in appellants' brief that the claimed polymer had an unexpectedly increased impact strength "are not entitled to the weight of conclusions accompanying the evidence, either in the specification or in a declaration.").
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of the nonobviousness fails to outweigh the evidence of obviousness.
Response to Arguments
Applicant’s remarks filed September 19, 2025 is acknowledged.
Applicant’s arguments have been fully considered but they are unpersuasive.
Applicant argues Anchel does not describe a whole egg substitute. There is no explanation of what the components are that would go into such an egg replacement product. One of ordinary skill in the art, at the time of the invention, would not have designed the particular liquid whole egg substitute composition formulation with its various components at specified percentage ranges. The Office Action used improper hindsight reconstruction to piece together this composition where it does not exist. There is no explanation of what weight percent to the composition of rOVA to include. One of ordinary skill, at the time of the invention, would not have known to select rOVA at the weight percent claimed. Anchel does not teach a skilled artisan which of these elements to select from the list in paragraph [0146] to include in a liquid whole egg substitute, nor would the skilled artisan have known to use the percentages stated in the claim to achieve a liquid whole egg substitute that was even near to native egg, much less one that performs equivalently or better than native egg. Rodriquez does not even mention ovalbumin, much less recombinant ovalbumin. One of ordinary skill in the art would not have known how to make the claimed rOVA liquid whole egg substitute based on Anchel and Rodriquez combined. There was no explanation in Anchel that water, gum, and salt should be included in an egg replacement product, nor how much to include. Thus, the Office Action cannot simply rely on routine experimentation in lieu of finding a reference providing the claimed rOVA formulation including the percentages of salt. Anchel does not even mention baking powder. Rodriquez does not help to teach the skilled artisan how much baking powder to add to an rOVA liquid whole egg substitute since it does not even describe using ovalbumin (P9-P13).
Examiner disagrees. The claimed invention is obvious in view of modified Anchel. Applicant is reminded that it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Additionally, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
As addressed above, Anchel as modified by Rodriguez teaches the claimed invention. Anchel relates to a liquid egg replacement composition comprising at least one recombinant egg-white protein including recombinant ovalbumin, one or more additives including binding agent, emulsifier, and thickener, less than 10% fat, lecithin, water, gum(s), and salt (paragraphs [0006], [0007], [0010], [0015], [0018], [0031], [0033], [0034], [0079]-[0083], [0088], [0095], [0098], [0099], [0107], [0133], [0135], [0136], [0145], [0146], [0149], [0150], [0152], and [0155]). While Anchel does not expressly disclose the lecithin amount, gum amount, and/or baking powder in the composition, Rodriguez is relied upon for these teachings (paragraphs [0009], [0039], [0048], [0062]-[0063], [0078], [0080], and [0089]). Rodriguez does not disclose all the features of the presently claimed invention. However, Rodriguez is used as teaching reference, and therefore, it is not necessary for this secondary reference to contain all the features of the presently claimed invention, In re Nievelt, 482 F.2d 965, 179 USPQ 224, 226 (CCPA 1973), In re Keller 624 F.2d 413, 208 USPQ 871, 881 (CCPA 1981).
One of ordinary skill in the art would have been motivated to select any portions of the disclosed ranges, including the instantly claimed ranges of lecithin and/or gum(s), from the ranges disclosed in the prior art with the expectation of successfully preparing an egg replacement composition because Anchel and Rodriguez similarly teach liquid egg replacement compositions comprising lecithin and gum, Anchel teaches the lecithin additives improve functional performance and/or physical characteristics and the concentration of the additives (gelation agent) may vary depending upon the formulation and can produce variations in consistency and palatability of the product (paragraphs [0146] and [0178]-[0179]), and Rodriguez teaches the egg-substitute composition may have one or more qualities of natural eggs (paragraph [0108]). "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages " In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.
Additionally, one of ordinary skill in the art would have been motivated to select baking powder based upon its suitability for its intended purpose in Anchel with the expectation of successfully preparing a functional egg replacement composition because Anchel and Rodriguez similarly teach liquid egg replacement compositions comprising similar ingredients, Anchel teaches the additive is not limited to pH adjusters such as sodium bicarbonate (paragraphs [0146] and [0148]), Rodriguez recognizes the equivalence of sodium bicarbonate and baking powder in egg substitute compositions and teaches the sodium bicarbonate/baking powder may be used as additional leavening agents in the egg substitute composition (paragraphs [0089] and [0108]), and said combination would amount to the use of a known element for its intended use in a known environment to accomplish entirely expected results. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. (“Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle.” Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) See also In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960) (selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious)) (MPEP 2144.07).
Further, one of ordinary skill in the art would have been motivated to optimize the amount of salt present in the composition of modified Anchel through routine experimentation with the expectation of successfully preparing a functional product because Anchel teaches the concentration of salt may vary depending upon the formulation and can produce variations in consistency and palatability of the product (paragraphs [0146] and [0178]-[0179]), and it is understood that, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. There would have been a reasonable expectation of success. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05 II).
Applicant argues the Declaration of Shayanti Minj pursuant to 37 CFR 1.132 (“Minj Dec.”) that was filed in the parent application is relevant also in this continuation application, so is included with this Response. This Minj Dec. presents additional experimental data showing the performance of different liquid whole egg substitute formulas as compared to native whole egg. The Formulas that performed the best were the ones that fell in the ranges provided in the claim, while others did not perform as well. Even if a skilled artisan made a recombinant formulation hat simply mimicked native whole egg in lipid content, it would not have performed very well, which was a surprising discovery. The low lipid egg substitute formulas also showed equivalent or superior texture characteristics, such as firmness and springiness compared to the native whole egg control. This too is an unexpected result. The Minj Declaration also shows that the amount of water affects performance of the composition. Dr. Minj also presented experimental data in her declaration showing that the addition of baking powder was associated with the improved sensory and texture characteristics of the liquid whole egg substitute formulas (P10-P13).
Examiner disagrees. As previously addressed, modified Anchel teaches the claimed invention, and Applicant has failed to establish the criticality of the claimed ranges. Applicant is reminded the evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) (Mere conclusions in appellants' brief that the claimed polymer had an unexpectedly increased impact strength "are not entitled to the weight of conclusions accompanying the evidence, either in the specification or in a declaration.").
Additionally, it is noted that the Declaration was filed for application 18057134 which has been abandoned. Although there is some overlap between the claims in application 18057134 and the instant application, it is noted that the data presented in Table 1 of the Declaration is not commensurate in scope with the invention of claims 19-30 of the instant application (the oil content in Table 1 is greater than the lipid component quantity in the claimed invention; and salt and baking powder as presently claimed is not present in Table 1 of the Declaration). Further, the Declaration was previously addressed for application 18057134 (see the Non-Final Rejection of April 11, 2024). Examiner’s position of the Declaration is maintained and has been provided above in the “Response to Amendments” section of this Office Action.
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