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 .
This office action has written in response to the Applicants Remarks filed 11/6/25. Applicants claims were revived on 11/6/25. Claims 209-239 are pending and have been examined on the merits. Claim 239 is new.
Withdrawn Rejections
The 103(a) rejections of claims 209, 210, 220-223, 226, 227, and 233-237over Lucey et al. (US 2009/0311407), Enohara (JP 2007/143485) and Pandya (US 9,924,728) have been withdrawn in view of the amendments to claim 209.
The 103(a) rejections of claims 211-219, 232, 237-238 over Lucey et al. (US 2009/0311407), Enohara (JP 2007/143485), Pandya (US 9,924,728) and Geistlinger et al. (WO 2018/039632) have been withdrawn in view of the amendments to claim 209.
The 103(a) rejections of claims 224, 225, 226, and 228-231 over Lucey et al. (US 2009/0311407), Enohara (JP 2007/143485) and Pandya (US 9,924,728) and Rodriguez et al. (WO 2015/170172) have been withdrawn in view of the amendments to claim 209.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 209, 210, 211-223, 226, 227, and 232-239 are rejected under 35 U.S.C. 103 as being unpatentable over Lucey et al. (US 2009/0311407) in view of Enohara (JP 2007/143485) 6/2007 Machine Translation and Pandya (US 9,924,728) and Geistlinger et al. (WO 2018/039632).
Regarding Claims 209, 210, and 239: Lucey discloses a protein-polysaccharide conjugate containing beta-lactoglobulin and a polysaccharide [Abstract; 0008; 0009]. Lucey discloses the polysaccharides including gums and starches [0005; 0053; 0032; 0039]. Lucey discloses 10-40% polysaccharide and 1-30% protein [claim 1]. Lucey discloses starches [0036; 0039]. Lucey does not disclose the composition as an egg replacer. However, Lucey discloses the composition as an emulsifying agent and for stabilizing compositions [0005; 0009; 0011] and it is known in the art that eggs provide these features in foods. Lucey discloses food compositions containing the beta-lactoglobulin and a polysaccharide with reduced allergenicity [0016; claim 23, 24]. Lucey discloses 1-30% protein; 5-20% and 10% protein [0038].
Lucey does not disclose “the egg replacer being suitable as a standalone substitute for egg-based food product, wherein the egg replacer imparts on the egg based food product an attribute imparted by egg in a comparable composition wherein the attribute is rise, taste, flavor, and eating quality.
Lucey does not disclose wherein the β-lactoglobulin is a recombinant β- lactoglobulin.
Lucey does not disclose a milk protein component consisting essentially of recombinant ß-lactoglobulin comprising at least one milk protein repeat of at least 10 amino acids that is at least 95% identical to a contiguous sequence of bovine ß-lactoglobulin, the repeat conferring enhanced foaming and gelling behavior.
Enohara discloses using β-lactoglobulin in a baked food product that is free of egg protein and where the product is comparable to a baked product made with egg, since the same “swelling” is found as with eggs [abstract; pg. 2]. Enohara discloses that the composition provides moderate elasticity and moist and soft texture [pg. 1]. Lucey does not disclose wherein the β-lactoglobulin is a recombinant β- lactoglobulin.
Pandya discloses a recombinant β- lactoglobulin and obtaining β- lactoglobulin in a composition that is able to provide binding and stabilizing and emulsifying properties to a food product [col. 11, lines 8-21; claim 1].
Geistlinger discloses a recombinant β-lactoglobulin that comprises milk protein repeats [pg. 5, lines 12-25; pg. 11, lines 14-20]. Geistlinger discloses glycosylation [pg. 4, lines 3-12]. Geistlinger discloses that the reduction of allergens, improvement in nutrient contents [pg. 9, lines 3-16]. Geistlinger discloses foam forming ability and gels [pg. 25, lines 14-25]. Geistlinger discloses a carbohydrate component between 0.001% and 25% derived from plants [pg. 34, lines 1-21].
At the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to modify the food products of Lucey to include essentially egg free products as in Enohara since Enohara discloses that baked products including cakes can be made using β-lactoglobulin and without egg and the same results can be achieved.
At the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to modify the composition of Lucey to include the β- lactoglobulin of Pandya as it is able to provide binding, stabilizing, emulsifying and other beneficial features to food products in line with what is also desirable in Lucey. Further, selections of alternative sources of β- lactoglobulin would have been within the desire of one of ordinary skill in the art.
At the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to further modify the composition of Lucey to include the β- lactoglobulin comprising a milk protein repeat as in Geistlinger as it is able to provide reduced allergens and improved nutrient content.
Further it would have been obvious to derive the carbohydrates from plants as they are known to be sources of carbohydrates.
Regarding the limitation, “wherein the egg replacer is essentially free of an egg protein, and wherein the egg replacer is essentially free of a gluten, and wherein, upon hydration or whipping. the egg replacer provides foaming overrun of at least 900% and a foam half-life of at least 120 minutes, thereby imparting to a baked food product a cake rise comparable to a product containing egg”, “Products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Regarding the limitation, “wherein the baked food product exhibits a rise within+10% of that of an equivalent cack formulation containing egg”, “Products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Regarding the amounts of carbohydrates, although Lucey does not explicitly disclose less than 20% one having ordinary skill in the art at the effective filing date of the invention would have considered the invention to have been obvious because the range taught by Lucey overlaps the instantly claimed range and therefore is considered to establish a prima facie case of obviousness. In re Malagari 182 USPQ 549,553.
Regarding Claims 211 and 238: Lucey as modified discloses wherein the β-lactoglobulin is a recombinant β- lactoglobulin as discussed above in claim 209.
Lucey as modified does not disclose that the recombinant β-lactoglobulin comprises at least two milk protein repeats consecutively or non-consecutively.
Pandya discloses a recombinant β- lactoglobulin and obtaining β- lactoglobulin in a composition that is able to provide binding and stabilizing and emulsifying properties to a food product [col. 11, lines 8-21; claim 1].
Geistlinger discloses a recombinant β-lactoglobulin that comprises milk protein repeats [pg. 5, lines 12-25; pg. 11, lines 14-20]. Geistlinger discloses glycosylation [pg. 4, lines 3-12]. Geistlinger discloses that the reduction of allergens, improvement in nutrient contents [pg. 9, lines 3-16]. Geistlinger discloses foam forming ability and gels [pg. 25, lines 14-25]. Geistlinger discloses milk protein repeats and therefore discloses at least two milk protein repeats. Geistlinger discloses that the milk protein repeats can be consecutive or non-consecutive [pg. 5, lines 12-25].
At the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to modify the composition of Lucey to include the β- lactoglobulin comprising a milk protein repeat as in Geistlinger as it is able to provide reduced allergens and improved nutrient content.
Regarding Claim 212-214: Lucey discloses as discussed above in claim 209. Lucey does not disclose wherein the recombinant β- lactoglobulin is at least 90% identical to bovine β-lactoglobulin (claim 212); wherein the recombinant β-lactoglobulin is at least 95% identical to bovine β-lactoglobulin (claim 213); wherein the recombinant β-lactoglobulin is at least 99% identical to bovine β-lactoglobulin (claim 214).
Pandya discloses a recombinant β- lactoglobulin that is at least 90%, 95% or 99% identical to mammal produced milk [col. 12, lines 43-52; col. 25, lines 16-27]. Mammalian milk includes bovine [claim 2; col. 25, lines 5-9].
Geistlinger discloses a milk protein that has a sequence that is 90, 95, and 99% identical to the sequence of a protein that is found in milk protein [pg. 5, lines 12-25]. Geistlinger discloses that the milk protein can be derived from a fungal host cell selected from Trichoderma reesei, Aspergillus niger, or Pichia pastoris [pg. 24, lines 23-33]. Geistlinger discloses pH levels of 4.1 to about 5.2 [pg. 59, lines 1-5]. Geistlinger discloses utilizing suitable pH levels and suitable temperatures [pg. 58, lines 6-14].
At the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to modify the composition of Lucey to include the recombinant β-lactoglobulin of Pandya and Geistlinger as it is able to provide binding, stabilizing, emulsifying and other beneficial features to food products in line with what is also desirable in Lucey. Further, selections of alternative sources of β- lactoglobulin would have been within the desire of one of ordinary skill in the art.
Further regarding the process limitations of claim 213, since there is no evidence that the recited process produces a product that is materially different from what is disclosed in the prior art, claim 213 has been considered regarding its disclosure of 213. “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior art was made by a different process.” In re Thorpe, 777 F.2d 695, 698.
Regarding Claim 215-219: Lucey discloses as discussed above in claim 209. Lucey does not disclose wherein the recombinant β-lactoglobulin is produced in a recombinant host cell selected from the group consisting of a recombinant fungal host cell, a recombinant bacterial host cell, a recombinant algal host cell, or a recombinant plant host cell (claim 215); wherein the recombinant fungal host cell is a recombinant yeast host cell (claim 216); wherein the recombinant yeast host cell is derived from a member of a genus selected from the group consisting of Kluyveromyces, Pichia, Saccharomyces, and Yarrowila (claim 217); wherein the recombinant fungal host cell is a recombinant filamentous fungal host cell (claim 218); wherein the recombinant filamentous fungal host cell is derived from a member of a genus selected from the group consisting of: Aspergillus, Fusarium, Myceliophthora, and Trichoderma (claim 219).
Pandya discloses a recombinant β- lactoglobulin that is produced in a recombinant host cell that is fungal/yeast or bacterial [col. 6, lines 53-58; col. 46, lines 8-18; claim 1]. Pandya discloses that the host cell is derived from a member of Kluyveromyces, Pichia, Saccharomyces, and Yarrowila [col. 6, lines 53-58]. Pandya discloses that the host cell is derived from a member of Kluyveromyces, Pichia, Saccharomyces, Yarrowila, Aspergillus, Fusarium, and Trichoderma [col. 18, lines 8-25].
At the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to modify the composition of Lucey to include the recombinant β-lactoglobulin derived from yeast or fungi or more specifically Kluyveromyces, Pichia, Saccharomyces, Yarrowila, Aspergillus, Fusarium, or Trichoderma of Pandya as it is able to provide binding, stabilizing, emulsifying and other beneficial features to food products in line with what is also desirable in Lucey. Further, selections of alternative sources of β- lactoglobulin would have been within the desire of one of ordinary skill in the art.
Regarding Claims 220 and 222: Lucey discloses as discussed above in claim 209. Lucey does not disclose post-transcriptional modification (claim 220); wherein the post-translational
modification comprises at least one of glycosylation, phosphorylation, alkylation, lipidation, or
hydroxylation (claim 222).
Pandya discloses post-transcriptional modification in the form of glycosylation [col. 12, lines 38-52; col. 13, lines 8-17; col. 25, lines 1-28; col. 46, lines 26-67].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the method of Lucey to include the glycosylation of Pandya to attach a sugar and increased the stability and solubility of the protein.
Regarding Claim 221: Lucey discloses as discussed above in claim 209. Lucey discloses 1-30% protein; 5-20% and 10% protein [0038].
Regarding Claim 223: Lucey discloses as discussed above in claim 222. Lucey discloses 10-40% polysaccharide [claim 1].
Regarding Claim 227: Lucey discloses as discussed above in claim 222. Lucey discloses a mixture of starch and gums (gum Arabic, agar) in more than one type can be used [0038, 0039; 0053].
Regarding Claim 232: Lucey discloses as discussed above in claim 209. Lucey does not disclose that the composition is in the form of a powder.
Pandya discloses the composition containing β- lactoglobulin in a powder form [col. 40, lines 52-57; claim 16].
At the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to further modify the composition of Lucey to provide the composition in powder form as in Pandya in order to provide a stable and easily administered composition.
Regarding Claim 233: Lucey discloses as discussed above in claim 209. Lucey discloses the conjugate composition in a composition [0047; claims 11, 19].
Regarding Claim 234: Lucey discloses as discussed above in claim 233. Lucey discloses the conjugate composition in a composition and the composition does not contain egg protein [0016; 0047; claims 11, 19].
Regarding Claim 235: Lucey discloses as discussed above in claim 233. Lucey discloses the conjugate composition in a composition and the composition is a food product [0060].
Regarding Claims 236 and 237: Lucey discloses as discussed above in claim 235. Lucey does not disclose wherein the food product is selected from the group consisting of a batter, dough, baked/cooked food product, and an egg based food product (claim 236); wherein the composition is a baked food product; wherein the baked food product is essentially free of an egg protein, a gluten, or both; and wherein the baked food product has a similar cake rise/height as a comparable baked food product comprising an egg, protein, a gluten, or both (claim 237).
Enohara discloses using β-lactoglobulin in a baked food product that is free of egg protein and where the product is comparable to a baked product made with egg, since the same “swelling” is found as with eggs [abstract; pg. 2].
At the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to modify the food products of Lucey to include essentially egg free products as in Enohara since Enohara discloses that baked products including cakes can be made using β-lactoglobulin and without egg and the same results can be achieved.
Claims 224, 225, 226, and 228-231 are rejected under 35 U.S.C. 103 as being unpatentable over Lucey et al. (US 2009/0311407) Enohara (JP 2007/143485) 6/2007 Machine Translation, Pandya (US 9,924,728) and Geistlinger et al. (WO 2018/039632) as applied to claims 222, 223, 227 and in further view of Rodriguez et al. (WO 2015/170172).
Regarding Claim 224: Lucey discloses as discussed above in claim 223. Lucey discloses starches [0036; 0039]. Lucey does not disclose wherein the starch is selected from the group consisting of tapioca starch, corn (maize) starch, potato starch, and any mixture of two or more thereof.
Rodriguez discloses an egg replacer composition containing β- lactoglobulin and a flour (which has a high starch content)/starch and that the flour/starch is contained in the composition is one or more of tapioca flour(starch), corn flour (starch), potato starch [abstract; 0077; 0078; 00207 Table X; 00208].
At the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to modify the composition of Lucey to include potato starch as in Rodriguez since Lucey discloses the incorporation of starches and since potato starch is disclosed in Rodriguez as a suitable binder and the selection of such would have been within the skill of one of ordinary skill in the art.
Regarding Claims 225: Lucey discloses as discussed above in claim 222. Lucey discloses the presence of gums [0053]. Lucey does not disclose wherein the egg replacer comprises between about 1% and about 5% by mass of a gum.
Rodriguez discloses an egg replacer composition containing gums at about 0.5 to about 20% and also discloses about 1 to about 5% [abstract; 0082].
At the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to modify the composition of Lucey to include gums at about 1 to 5% as in Rodriguez since Lucey discloses the incorporation of gums and since the amount of gums as disclosed in Rodriguez is able to provide a stabilizing and gelling effect [0080-0083; 0208].
Regarding Claim 226: Lucey discloses as discussed above in claim 225. Lucey discloses gum Arabic, agar [0039; 0053].
Regarding Claim 228: Lucey discloses as discussed above in claim 227. Lucey discloses starches [0036; 0039]. Lucey does not disclose wherein the starch is selected from the group consisting of tapioca starch, corn (maize) starch, potato starch, arrowroot starch, tapioca syrup solids, rice syrup solids, and any mixture of two or more thereof .
Rodriguez discloses an egg replacer composition containing β- lactoglobulin and a flour (which has a high starch content)/starch and that the flour/starch is contained in the composition is one or more of tapioca flour(starch), corn flour (starch), potato starch, arrowroot starch [abstract; 0077; 0078; 00207 Table X; 00208].
At the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to modify the composition of Lucey to include tapioca, corn, potato starch and arrowroot as in Rodriguez since Lucey discloses the incorporation of starches and since potato starch and arrowroot powder is disclosed in Rodriguez as a suitable binder and the selection of such would have been within the skill of one of ordinary skill in the art.
Regarding Claim 229: Lucey discloses as discussed above in claim 227. Lucey discloses gum Arabic, agar [0039; 0053].
Rodriguez discloses an egg replacer composition containing β- lactoglobulin and gums including xanthan, locust bean, guar, acacia (gum Arabic)[abstract; 0080; 00207 Table X; 00208].
Regarding Claim 230: Lucey discloses as discussed above in claim 227. Lucey discloses starches [0036; 0039]. Lucey discloses gum Arabic, agar [0039; 0053].
Lucey does not disclose wherein the starch is selected from the group consisting of tapioca starch, corn (maize) starch, potato starch, arrowroot starch, tapioca syrup solids, rice syrup solids, and any mixture of two or more thereof.
Rodriguez discloses an egg replacer composition containing β- lactoglobulin and a flour (which has a high starch content)/starch and that the flour/starch is contained in the composition is one or more of tapioca flour(starch), corn flour (starch), potato starch, arrowroot starch [abstract; 0077; 0078; 00207 Table X; 00208]. Rodriguez discloses an egg replacer composition containing β- lactoglobulin and gums including xanthan, locust bean, guar, acacia (gum Arabic)[abstract; 0080; 00207 Table X; 00208].
At the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to modify the composition of Lucey to include tapioca, corn, potato starch or arrowroot as in Rodriguez since Lucey discloses the incorporation of starches and since potato starch and arrowroot powder is disclosed in Rodriguez as a suitable binder and the selection of such would have been within the skill of one of ordinary skill in the art.
Regarding Claim 231: Lucey discloses as discussed above in claim 227. Lucey discloses starches [0036; 0039]. Lucey discloses gum Arabic, agar [0039; 0053].
Lucey does not disclose wherein the egg replacer comprises between about 10% and about 40% by mass of the starch and between about 1% and about 5% by mass of the gum.
Rodriguez discloses an egg replacer composition containing β- lactoglobulin and that starch is contained in the composition as potato starch and arrowroot powder [abstract; 0078; 00207 Table X; 00208]. Rodriguez discloses an egg replacer composition containing β- lactoglobulin and gums including xanthan, locust bean, guar, acacia (gum Arabic)[abstract; 0080; 00207 Table X; 00208]. Rodriguez discloses starches at 15% to 45% [00207]. Rodriguez discloses stabilizers/gum at about 0.5% to 10% and at about 1 to about 5% [00207; 0082].
At the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to modify the composition of Lucey to include starches and gums at the amounts as disclosed in Rodriguez in order to provide an egg replacer providing binding, moisturizing, leavening, emulsifying, and other properties similar to eggs [00110].
Response to Arguments
The 103(a) rejections of claims 209, 210, 220-223, 226, 227, and 233-237over Lucey et al. (US 2009/0311407), Enohara (JP 2007/143485) and Pandya (US 9,924,728) have been withdrawn in view of the amendments to claim 209.
The 103(a) rejections of claims 211-219, 232, 237-238 over Lucey et al. (US 2009/0311407), Enohara (JP 2007/143485), Pandya (US 9,924,728) and Geistlinger et al. (WO 2018/039632) have been withdrawn in view of the amendments to claim 209.
The 103(a) rejections of claims 224, 225, 226, and 228-231 over Lucey et al. (US 2009/0311407), Enohara (JP 2007/143485) and Pandya (US 9,924,728) and Rodriguez et al. (WO 2015/170172) have been withdrawn in view of the amendments to claim 209.
The Applicants assert Unexpected Results and functional synergy. However, even in view of the amendments the prior art disclose the limitations regarding the structure of the egg replacer and therefore render the claims obvious. The Geistlinger reference discloses the same or substantially similar milk recombinant proteins as recited by Applicants.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FELICIA C TURNER whose telephone number is (571)270-3733. The examiner can normally be reached Mon-Thu 8:00-4:00 pm.
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/Felicia C Turner/Primary Examiner, Art Unit 1793
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