DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
Receipt of the Response and Amendment after Non-Final Office Action filed 23 June 2026 is acknowledged.
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 18-41
Withdrawn claims: None
Previously canceled claims: None
Newly canceled claims: 1-17
Amended claims: 18
New claims: 27-41
Claims currently under consideration: 18-41
Currently rejected claims: 18-41
Allowed claims: None
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 39 and 41 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 39 recites the limitation, “The method of claim 35, wherein the animal fat…”. There is insufficient antecedent basis for “the animal fat” in the claim because no “animal fat” was previously recited in claim 35 or independent claim 18 from which claims 35 and 39 depend. However, claim 38 recites “wherein the hybrid meat substitute further comprises at least 1% animal fat by weight”. For purposes of examination, claim 39 is construed as being dependent from claim 38.
The term “near zero level” in claim 41 is a relative term which renders the claim indefinite. The term “near zero level” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For example, a “near zero level” could be 5%, 2%, 1%, 0.5%, 0.1%, 0.01%, 0.001%, etc. Therefore, the scope of the amount of endogenous heme containing protein present in the animal cell is indefinite.
Regarding animal cells having a near zero level of endogenous heme containing protein, the instant specification at paragraph [0073] provides:
The low heme-containing protein content problems of traditional hybrid meat products are further complicated when using cultivated cells. Cultivated cells have been reported to produce significantly lower levels of heme-containing proteins than their harvested meat counterparts. Moreover, cultivated cells that are not fully differentiated into muscle or organ tissue (e.g., have not developed muscle fibers) have near zero contents of heme-containing proteins. In some embodiments, the hybrid meat substitute products of the present disclosure are not fully differentiated, and have low levels of endogenous (naturally produced within the cell) heme- containing protein.
Therefore, for purposes of examination, prior art utilizing cultured animal cells that are not fully differentiated into muscle or organ tissue is construed as meeting the limitation, “wherein the animal cell contains a near zero level of endogenous heme containing protein”.
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 18, 20-23, 26-41 are rejected under 35 U.S.C. 103 as being unpatentable over Savir et al. (US 2020/0100525 A1, cited on the IDS filed on 2 October 2023).
Regarding claim 18, Savir teaches a method of producing a hybrid substitute meat product – “According to an aspect of some embodiments of the present invention there is provided a method of preparing a hybrid foodstuff…” ([0038]). “According to some embodiments of the invention, the foodstuff is a meat substitute.” ([0062]).
comprising mixing cultured animal cells and an exogenous heme-containing protein with a plant-based meat dough – The method of Savir comprises:
a) “providing a plant-originated substance” ([0039]). The plant-originated substance fraction is considered to be a plant-based meat dough given that the foodstuff may comprise about 70% to 99.7% (w/w) plant originated substances and additives thereof (e.g., gum, binding, thickening, aroma, flavor additives) ([0279]). This is supported by, for instance, Example 2, which comprises soy protein tissue, soy protein isolate, sodium caseinate, potato starch, corn starch, water, gluten, guar gum, and methylcellulose (MC) ([0368] – [0369]), which are all typical components of a plant-based meat dough.
b) “providing cultured meat, cells and substances thereof” ([0040]). The term “cultured meat” is interchangeably used with “cultured animal cells”. ([0150]). Savir teaches that “According to some embodiments of the invention, at least about 50% of cultured meat portion is cultured meat cells selected from a group consisting of heme-proteins (HPs), hepatocytes, myoblasts…and any combinations thereof.” ([0055]). Therefore, at least about 50% of the cultured meat portion may be heme proteins, alone or in combination with cultured animal cells. Savir teaches that heme proteins are cultured in various methods and various sources, including several types of cells that can differentiate into a variety of cell types ([0309]; see also [0050], [0322]) and that hepatocytes are enriched by hemoglobin and myoglobin and thus provide meat-like foods with improved organoleptic properties including meat-like color, texture, mouthfeel, odor, flavor, and appearance ([0310]). Savir uses hepatocytes in Example 2 ([0370]) as a source of heme proteins. Savir further teaches that “cultured cells can be used in their native form in the hybrid foodstuff or treated or genetically engineered to enrich a certain trait/phenotype e.g., level of expression of HPs [i.e., heme proteins].” ([0312]).
Regarding “exogenous heme-containing protein”, the instant specification provides the following in paragraph [0056]:
In some embodiments, the exogenous heme- containing protein is provided as part of another ingredient in the hybrid meat substitute product (e.g., in a complex extract or within cells that artificially express the heme-containing product). When provided within a cell, the exogenous heme-containing protein is 1) expressed in the cell from an exogenous gene (i.e., the protein does not exist in the wild type cells); and/or 2) is expressed at super physiological levels due to one or more genetic modification(s) to the cells (e.g., by adding extra copies of a gene encoding a heme-containing protein, or genetically engineering the gene loci encoding the native heme-containing protein for overexpression).
The teaching of Savir that hepatocytes (or other cultured cells) used in the hybrid foodstuff may be genetically engineered to enrich a level of expression of heme proteins is deemed to be in accordance with Applicant’s description of “exogenous heme-containing proteins”, and thus meets the requirement for an exogenous heme-containing protein.
c) “interconnecting the plant-originated substance with the cultured meat, cells and substances thereof” ([0041]). The term “interconnecting” includes mixing the components ([0213]).
wherein the hybrid substitute meat product contains at least 1% by weight cultured animal cells – “According to some embodiments of the invention, the cultured meat, cells and substances thereof is from about 0.5% to about 18% (w/w).” ([0044]). The claimed range of at least 1% overlaps the disclosed range. In a case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists, MPEP § 2144.05(I).
and between 0.1%-1.0% by weight exogenous heme-containing protein – Savir teaches “[a] chicken-flavored cultured-meat containing foodstuff, where the differentiated hepatocytes cells are cultivated to provide about 0.1% to about 0.7% HPs [ i.e., heme proteins]” ([0311]). See also Table 3 ([0315]), which provides examples of different products comprising weight percentages of heme proteins within the claimed range.
Savir does not explicitly discuss that the cultured animal cells and the exogenous heme-containing protein synergistically improve the meaty flavor of the hybrid meat substitute product.
However, Savir discloses the claimed step of mixing the claimed ingredients in the claimed amounts. When the method steps recited in the prior art reference are substantially identical to those of the claims, claimed properties of the resulting composition are presumed to be present in the composition of the prior art. The burden of proof shifts to the applicant to provide objective evidence (i.e., test data) to the contrary. See In re Best, 562, F.2d 1252, 1254, 195 USPQ 403, 433 (CCPA 1977). MPEP § 2112.01(I).
As such, the property that the cultured animal cells and the exogenous heme-containing protein synergistically improve the meaty flavor of the hybrid meat substitute product is presumed to be present in the hybrid meat substitute of Savir.
Claim 18 is therefore rendered obvious.
Regarding claim 20, Savir teaches the method of claim 18, wherein plant-based meat dough is at least 30% by weight – The plant-originated substance fraction, considered to be a plant-based meat dough, is from about 70% to 99.7% (w/w) plant originated substances and additives thereof (e.g., gum, binding, thickening, aroma, flavor additives) ([0279]).
and wherein the exogenous heme-containing protein is at least 0.50% by weight in the hybrid substitute meat product – Savir teaches “[a] beef-flavored cultured-meat containing foodstuff, where the differentiated hepatocytes cells are cultivated to provide about 0.75 to about 2.5% HPs [ i.e., heme proteins]” ([0311]). See also Table 3 ([0315]), which provides examples of different products comprising weight percentages of heme proteins within the claimed range.
Claim 20 is therefore rendered obvious.
Regarding claim 21, Savir teaches the method of claim 20, wherein the hybrid substitute meat product further comprises at least 0.1% animal fat by weight – Paragraph [0055] of the instant specification states, “In some embodiments, the animal fat is provided in the form of adipocyte cells.” Savir teaches that “adipocytes may be used to confer a non-meat food with a meaty taste and/or texture (e.g., beef or chicken) when cooked or grilled.” ([0067]). Savir teaches that “at least about 50% of the cultured meat portion is cultured meat cells selected from a group consisting of …lipoblasts…mesenchymal stem cells…and any combinations thereof.” ([0055]). Lipoblasts are immature adipocytes. Savir teaches that mesenchymal stem cells may be differentiated into adipocytes ([0161], [0163]), and also teaches differentiation of chicken adipocytes from ES cells ([0176] – [0180]). Regarding the amount, Savir states, “According to some embodiments of the invention, the cultured meat, cells and substances thereof is from about 0.5% to about 18% (w/w).” ([0044]). The adipocytes alone or in combination with the other disclosed types of cultured animal cells therefore may be within the range from about 0.5% to about 18% (w/w). This range lies inside the claimed range.
Claim 21 is therefore rendered obvious.
Regarding claim 22, Savir teaches the method of claim 18, wherein the exogenous heme-containing protein improves olfactory appeal factors, visual appeal factors, and/or flavor appeals – Savir teaches, “The two main heme proteins (HPs), hemoglobin and myoglobin, are important factors determining meat quality aspects such as color…” ([0308]), and “[h]epatocytes are enriched by those two main HPs and thus provide meat-like foods with improved organoleptic properties including meat-like color, texture, mouth feel, odor, flavor and appearance.” ([0310]).
Claim 22 is therefore rendered obvious.
Regarding claim 23, Savir teaches the method of claim 18, wherein the cultured animal cells are cultivated in a cultivation infrastructure – Paragraph [00219 of the instant specification states, “A ‘cultivation infrastructure’ refers to the environment in which the cell population (i.e., cellular biomass) are cultured. A cultivation infrastructure may be a tube, a cylinder, a flask, a petri-dish, a multi-well plate, a dish, a vat, an incubator, a bioreactor, an industrial fermenter and the like. A cultivation infrastructure may be a culture medium in which metazoan cells are cultured.” Where Savir teaches cultured animal cells, the cells necessarily are cultivated in a cultivation infrastructure. Savir also teaches that in chicken adipocyte differentiation from ES cells, cells are cultivated in tissue culture dishes and flasks using a variety of cell culture media ([0176] – [0180]).
Claim 23 is therefore rendered obvious.
Regarding claim 26, Savir teaches the method of claim 18, wherein the cultured animal cells are cultivated in a suspension culture – “According to a specific embodiment, the cells are produced in a suspension culture.” ([0171]).
Claim 26 is therefore rendered obvious.
Regarding claims 27-30, Savir teaches the method of claim 18.
Paragraph [0309] of Savir provides:
It is well in the scope of the invention where HPs are cultured in various methods, various sources, including, e.g., liver, bone marrow, mesenchymal cells or any other multipotent stromal cells that can differentiate into a variety of cell types, including osteoblasts (bone cells), chondrocytes (cartilage cells), myocytes (muscle cells) and adipocytes (fat cells)…
Additionally, paragraph [0322] of Savir provides:
In other embodiment of the present invention, the hybrid food comprises ex vivo produced cells (cultured animal cells) selected in a non-limiting manner from a group consisting of myoblasts, osteoblasts, fibroblasts, lipoblasts, odontoblasts, adult neuronal progenitor cells, neural stem cells, multipotent stem cells from subventricular forebrain region, ependymal-derived neural stem cells, hematopoietic stem cells, liver-derived hematopoietic stem, marrow-derived stem cell, adipo-fibroblasts, adipose-derived stem cells, islet-cells producing stem cells, pancreatic-derived pluripotent islet-producing stem cells, mesenchymal stem cells, bone marrow stromal cells, muscle side population cells, bone marrow-derived recycling cells, blood-derived mesenchymal precursor cells, bone-marrow derived side population cells, muscle precursor cells, circulating skeleton stem cells, neural progenitor cells, multipotent adult progenitor cells, mesodermal progenitor cells, spinal cord progenitor cells and spore-like cell, mixtures or any combinations thereof..
Therefore, Savir teaches that the cultured animal cells are selected from at least myoblasts, fibroblasts, mesenchymal stem cells, and adipose progenitor cells regarding claim 27; myoblasts regarding claim 28; undifferentiated cultivated myoblast cells (cultured myoblasts, which are undifferentiated) regarding claim 29, and fibroblasts regarding claim 30.
Claims 27-30 are therefore rendered obvious.
Regarding claim 31, Savir teaches the method of claim 18.
Savir also teaches embodiments wherein the cultured animal cells are not hepatocytes – Paragraph [0309] of Savir provides:
It is well in the scope of the invention where HPs are cultured in various methods, various sources, including, e.g., liver, bone marrow, mesenchymal cells or any other multipotent stromal cells that can differentiate into a variety of cell types, including osteoblasts (bone cells), chondrocytes (cartilage cells), myocytes (muscle cells) and adipocytes (fat cells); yet for convenient and in a non-limiting manner, one set of examples will be hereto disclosed.
Although Savir uses the example of hepatocytes ([0310] – [0312]), Savir discloses many other suitable cultured animal cell types that can be used in the invention ([0309]; [0322]).
MPEP § 2123(I) states, “‘The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.’ In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989).”
Furthermore, MPEP § 2144.07 states, “The selection of a known material based on its suitability for its intended use support[s] a prima facie obviousness determination”.
Since Savir discloses that the cultured animal cell types other than hepatocytes are suitable for use in preparing the hybrid meat substitute product, it would have been prima facie obvious to select any of the other cultured animal cell types disclosed by Savir.
Claim 31 is therefore rendered obvious.
Regarding claim 32, Savir teaches the method of claim 18.
Savir also teaches that the hybrid substitute meat product contains between 2%-30% by weight cultured animal cells – “According to some embodiments of the invention, the cultured meat, cells and substances thereof is from about 0.5% to about 18% (w/w).” ([0044]). The claimed range of between 2%-30% overlaps the disclosed range. In a case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists, MPEP § 2144.05(I).
Claim 32 is therefore rendered obvious.
Regarding claim 33, Savir teaches the method of claim 18.
Savir also teaches that the cultured animal cells are non-human animal cells – “As used herein ‘animal cells’ refer to ‘non-human cells’.” ([0092]).
Claim 33 is therefore rendered obvious.
Regarding claims 34-35, Savir teaches the method of claim 18.
Savir does not explicitly discuss that the hybrid substitute meat product exhibits at least 10% (re: claim 34) or at least a 30% (re: claim 35) increase in meaty flavor scores compared to an analogous product containing animal cells but lacking an exogenous heme-containing protein.
However, Savir discloses the claimed step of mixing the claimed ingredients in the claimed amounts. When the method steps recited in the prior art reference are substantially identical to those of the claims, claimed properties of the resulting composition are presumed to be present in the composition of the prior art. The burden of proof shifts to the applicant to provide objective evidence (i.e., test data) to the contrary. See In re Best, 562, F.2d 1252, 1254, 195 USPQ 403, 433 (CCPA 1977). MPEP § 2112.01(I).
As such, the property that the hybrid substitute meat product exhibits at least a 10% or at least a 30% increase in meaty flavor scores is presumed to be present in the hybrid meat substitute of Savir.
Therefore, where claim 18 is obvious, claims 34-35 are also rendered obvious.
Regarding claims 36 and 37, Savir teaches the method of claims 18 and 33, respectively.
Savir also teaches that the exogenous heme-containing protein is a myoglobin – Savir teaches examples of “[a] chicken-flavored cultured-meat containing foodstuff, where the differentiated hepatocytes cells are cultivated to provide about 0.1% to about 0.3% myoglobin” ([0311]). See also Table 3 ([0315]), which provides examples of different products comprising in vitro produced myoglobin ([0314] – [0316]).
Claims 36-37 are therefore rendered obvious.
Regarding claims 38-39, Savir teaches the method of claim 18, wherein the hybrid substitute meat product further comprises at least 1% animal fat by weight (re: claim 38), wherein the animal fat is provided in the form of fat cells or as an exogenous fat (re: claim 39) – Paragraph [0055] of the instant specification states, “In some embodiments, the animal fat is provided in the form of adipocyte cells.” Savir teaches that “adipocytes may be used to confer a non-meat food with a meaty taste and/or texture (e.g., beef or chicken) when cooked or grilled.” ([0067]). Savir teaches that “at least about 50% of the cultured meat portion is cultured meat cells selected from a group consisting of …lipoblasts…mesenchymal stem cells…and any combinations thereof.” ([0055]). Lipoblasts are immature adipocytes. Savir teaches that mesenchymal stem cells may be differentiated into adipocytes ([0161], [0163]), and also teaches differentiation of chicken adipocytes from ES cells ([0176] – [0180]). Regarding the amount, Savir states, “According to some embodiments of the invention, the cultured meat, cells and substances thereof is from about 0.5% to about 18% (w/w).” ([0044]). The adipocytes alone or in combination with the other disclosed types of cultured animal cells therefore may be within the range from about 0.5% to about 18% (w/w). The claimed range of at least 1% by weight overlaps the disclosed range. In a case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists, MPEP § 2144.05(I).
Claims 38-39 are therefore rendered obvious.
Regarding claim 40, Savir teaches a method of producing a hybrid substitute meat product – “According to an aspect of some embodiments of the present invention there is provided a method of preparing a hybrid foodstuff…” ([0038]). “According to some embodiments of the invention, the foodstuff is a meat substitute.” ([0062]).
comprising mixing cultured animal cells and an exogenous heme-containing protein with a plant-based meat dough – The method of Savir comprises:
a) “providing a plant-originated substance” ([0039]). The plant-originated substance fraction is considered to be a plant-based meat dough given that the foodstuff may comprise about 70% to 99.7% (w/w) plant originated substances and additives thereof (e.g., gum, binding, thickening, aroma, flavor additives) ([0279]). This is supported by, for instance, Example 2, which comprises soy protein tissue, soy protein isolate, sodium caseinate, potato starch, corn starch, water, gluten, guar gum, and methylcellulose (MC) ([0368] – [0369]), which are all typical components of a plant-based meat dough.
b) “providing cultured meat, cells and substances thereof” ([0040]). The term “cultured meat” is interchangeably used with “cultured animal cells”. ([0150]). Savir teaches that “According to some embodiments of the invention, at least about 50% of cultured meat portion is cultured meat cells selected from a group consisting of heme-proteins (HPs), hepatocytes, myoblasts…and any combinations thereof.” ([0055]). Therefore, at least about 50% of the cultured meat portion may be heme proteins, alone or in combination with cultured animal cells. Savir teaches that heme proteins are cultured in various methods and various sources, including several types of cells that can differentiate into a variety of cell types ([0309]; see also [0050], [0322]) and that hepatocytes are enriched by hemoglobin and myoglobin and thus provide meat-like foods with improved organoleptic properties including meat-like color, texture, mouthfeel, odor, flavor, and appearance ([0310]). Savir uses hepatocytes in Example 2 ([0370]) as a source of heme proteins. Savir further teaches that “cultured cells can be used in their native form in the hybrid foodstuff or treated or genetically engineered to enrich a certain trait/phenotype e.g., level of expression of HPs [i.e., heme proteins].” ([0312]).
Regarding “exogenous heme-containing protein”, the instant specification provides the following in paragraph [0056]:
In some embodiments, the exogenous heme- containing protein is provided as part of another ingredient in the hybrid meat substitute product (e.g., in a complex extract or within cells that artificially express the heme-containing product). When provided within a cell, the exogenous heme-containing protein is 1) expressed in the cell from an exogenous gene (i.e., the protein does not exist in the wild type cells); and/or 2) is expressed at super physiological levels due to one or more genetic modification(s) to the cells (e.g., by adding extra copies of a gene encoding a heme-containing protein, or genetically engineering the gene loci encoding the native heme-containing protein for overexpression).
The teaching of Savir that hepatocytes (or other cultured cells) used in the hybrid foodstuff may be genetically engineered to enrich a level of expression of heme proteins is deemed to be in accordance with Applicant’s description of “exogenous heme-containing proteins”, and thus meets the requirement for an exogenous heme-containing protein.
c) “interconnecting the plant-originated substance with the cultured meat, cells and substances thereof” ([0041]). The term “interconnecting” includes mixing the components ([0213]).
wherein the hybrid substitute meat product contains at least 1% by weight cultured animal cells – “According to some embodiments of the invention, the cultured meat, cells and substances thereof is from about 0.5% to about 18% (w/w).” ([0044]). The claimed range of at least 1% overlaps the disclosed range. In a case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists, MPEP § 2144.05(I).
between 0.1%-1.0% by weight exogenous heme-containing protein – Savir teaches “[a] chicken-flavored cultured-meat containing foodstuff, where the differentiated hepatocytes cells are cultivated to provide about 0.1% to about 0.7% HPs [ i.e., heme proteins]” ([0311]). See also Table 3 ([0315]), which provides examples of different products comprising weight percentages of heme proteins within the claimed range.
and at least 1% by weight animal fat – Paragraph [0055] of the instant specification states, “In some embodiments, the animal fat is provided in the form of adipocyte cells.” Savir teaches that “adipocytes may be used to confer a non-meat food with a meaty taste and/or texture (e.g., beef or chicken) when cooked or grilled.” ([0067]). Savir teaches that “at least about 50% of the cultured meat portion is cultured meat cells selected from a group consisting of …lipoblasts…mesenchymal stem cells…and any combinations thereof.” ([0055]). Lipoblasts are immature adipocytes. Savir teaches that mesenchymal stem cells may be differentiated into adipocytes ([0161], [0163]), and also teaches differentiation of chicken adipocytes from ES cells ([0176] – [0180]). Regarding the amount, Savir states, “According to some embodiments of the invention, the cultured meat, cells and substances thereof is from about 0.5% to about 18% (w/w).” ([0044]). The adipocytes alone or in combination with the other disclosed types of cultured animal cells therefore may be within the range from about 0.5% to about 18% (w/w). The claimed range of at least 1% by weight overlaps the disclosed range. In a case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists, MPEP § 2144.05(I).
Savir does not explicitly discuss that the cultured animal cells and the exogenous heme-containing protein synergistically improve the meaty flavor of the hybrid meat substitute product.
However, Savir discloses the claimed step of mixing the claimed ingredients in the claimed amounts. When the method steps recited in the prior art reference are substantially identical to those of the claims, claimed properties of the resulting composition are presumed to be present in the composition of the prior art. The burden of proof shifts to the applicant to provide objective evidence (i.e., test data) to the contrary. See In re Best, 562, F.2d 1252, 1254, 195 USPQ 403, 433 (CCPA 1977). MPEP § 2112.01(I).
As such, the property that the cultured animal cells and the exogenous heme-containing protein synergistically improve the meaty flavor of the hybrid meat substitute product is presumed to be present in the hybrid meat substitute of Savir.
Claim 40 is therefore rendered obvious.
Regarding claim 41, Savir teaches a method of producing a hybrid substitute meat product – “According to an aspect of some embodiments of the present invention there is provided a method of preparing a hybrid foodstuff…” ([0038]). “According to some embodiments of the invention, the foodstuff is a meat substitute.” ([0062]).
comprising mixing cultured animal cells and an exogenous heme-containing protein with a plant-based meat dough – The method of Savir comprises:
a) “providing a plant-originated substance” ([0039]). The plant-originated substance fraction is considered to be a plant-based meat dough given that the foodstuff may comprise about 70% to 99.7% (w/w) plant originated substances and additives thereof (e.g., gum, binding, thickening, aroma, flavor additives) ([0279]). This is supported by, for instance, Example 2, which comprises soy protein tissue, soy protein isolate, sodium caseinate, potato starch, corn starch, water, gluten, guar gum, and methylcellulose (MC) ([0368] – [0369]), which are all typical components of a plant-based meat dough.
b) “providing cultured meat, cells and substances thereof” ([0040]). The term “cultured meat” is interchangeably used with “cultured animal cells”. ([0150]). Savir teaches that “According to some embodiments of the invention, at least about 50% of cultured meat portion is cultured meat cells selected from a group consisting of heme-proteins (HPs)…myoblasts, osteoblasts, fibroblasts, lipoblasts, odontoblasts…and any combinations thereof.” ([0055]; [0322]). Therefore, at least about 50% of the cultured meat portion may be heme proteins, alone or in combination with cultured animal cells. It is noted that the vast majority of the suitable cell types disclosed by Savir are undifferentiated cells. Savir teaches that heme proteins are cultured in various methods and various sources, including several types of cells that can differentiate into a variety of cell types ([0309]; see also [0050], [0322]) and that “cultured cells can be used in their native form in the hybrid foodstuff or treated or genetically engineered to enrich a certain trait/phenotype e.g., level of expression of HPs [i.e., heme proteins].” ([0312]).
Regarding “exogenous heme-containing protein”, the instant specification provides the following in paragraph [0056]:
In some embodiments, the exogenous heme- containing protein is provided as part of another ingredient in the hybrid meat substitute product (e.g., in a complex extract or within cells that artificially express the heme-containing product). When provided within a cell, the exogenous heme-containing protein is 1) expressed in the cell from an exogenous gene (i.e., the protein does not exist in the wild type cells); and/or 2) is expressed at super physiological levels due to one or more genetic modification(s) to the cells (e.g., by adding extra copies of a gene encoding a heme-containing protein, or genetically engineering the gene loci encoding the native heme-containing protein for overexpression).
The teaching of Savir that (undifferentiated) cultured animal cells used in the hybrid foodstuff may be genetically engineered to enrich a level of expression of heme proteins is deemed to be in accordance with Applicant’s description of “exogenous heme-containing proteins”, and thus meets the requirement for an exogenous heme-containing protein.
c) “interconnecting the plant-originated substance with the cultured meat, cells and substances thereof” ([0041]). The term “interconnecting” includes mixing the components ([0213]).
wherein the animal cell contains near zero level of endogenous heme containing protein – As stated above, the vast majority of the suitable cell types disclosed by Savir are undifferentiated cells. As evidenced by the instant specification at paragraph [0073], “…cultivated cells that are not fully differentiated into muscle or organ tissue (e.g., have not developed muscle fibers) have near zero contents of heme-containing proteins.”
It is therefore expected that the undifferentiated cells disclosed by Savir have a “near zero” amount of endogenous heme expression. As such, Savir meets the limitation, “wherein the animal cell contains near zero level of endogenous heme containing protein”.
Claim 41 is therefore rendered obvious.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Savir et al. as applied to claim 18 above, and further in view of Vrljic et al. (US 2021/0051977 A1, cited on the IDS filed on 2 October 2023).
Regarding claim 19, Savir teaches the method of claim 18.
Savir does not discuss that the exogenous heme-containing protein is provided as an isolated ingredient.
However, Vrljic teaches methods and compositions for the production of non-meat consumable products, e.g., a meat substitute (Abstract). Vrljic teaches “a method for imparting a beef like flavor to consumable product, comprising adding to the consumable composition a heme-containing protein, wherein after cooking, a beef-like flavor is imparted to the consumable composition.” ([0045]). “In some embodiments, heme-containing proteins are isolated and purified from other components of the source material…” ([0139]). The heme-containing protein may be a hemoglobin, or a myoglobin, among others ([0130]).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute the genetically engineered hepatocytes of Savir with the isolated heme-containing protein of Vrljic by simple substitution of one known element for another to obtain predictable results. See MPEP § 2143(I)(B). First, Savir teaches “According to some embodiments of the invention, at least about 50% of cultured meat portion is cultured meat cells selected from a group consisting of heme-proteins (HPs), hepatocytes, myoblasts…and any combinations thereof.” ([0055]). Therefore, at least about 50% of the cultured meat portion may be heme proteins, alone or in combination with cultured animal cells. Savir teaches that heme proteins are cultured in various methods and various sources ([0309]) and that hepatocytes are enriched by hemoglobin and myoglobin and thus provide meat-like foods with improved organoleptic properties including meat-like color, texture, mouthfeel, odor, flavor, and appearance ([0310]). Savir uses hepatocytes in Example 2 ([0370]) as a source of heme proteins. Savir further teaches that “cultured cells can be used in their native form in the hybrid foodstuff or treated or genetically engineered to enrich a certain trait/phenotype e.g., level of expression of HPs [i.e., heme proteins].” ([0312]).
Vrljic teaches adding a heme-containing protein to a meat substitute, wherein after cooking, a beef-like flavor is imparted to the consumable composition.” ([0045]), and that the heme-containing proteins may isolated and purified from other components of the source material…” ([0139]). The heme-containing protein may be a hemoglobin, or a myoglobin, among others ([0130]).
Therefore, one of ordinary skill in the art would have recognized that substituting the isolated heme protein (hemoglobin/myoglobin) of Vrljic for the genetically engineered hepatocytes overexpressing heme proteins (hemoglobin/myoglobin) would have achieved the predictable result of providing the hybrid meat substitute with beef-like flavor and other organoleptic properties.
Claim 19 is therefore rendered obvious.
Claims 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Savir et al. as applied to claim 23 above, and further in view of Elfenbein et al. (US 2020/0140821 A1, cited on the IDS filed on 2 October 2023).
Regarding claims 24 and 25, Savir teaches the method of claim 23.
Savir does not discuss that the cultivation infrastructure comprises a bioreactor (re: claim 24) or that the bioreactor ranges from about 1,000 L to about 100,000 L (re: claim 25).
However, Elfenbein teaches systems and methods for producing cell cultured food products (Abstract). The cells include myocytes and adipocytes grown in suspension culture ([0011]), as well as differentiated embryonic stem cells ([0081]). Elfenbein teaches, “scalable bioreactors provide the requisite growth needed for mass production. In some instances, three-dimensional scaffolding is used to provide structural support and guide the growth of the cultured cells into the desired structure and/or texture analogous with the equivalent food product produced using conventional methods. Alternatively, or in combination, micro-scaffolds enable the growth of adherent cells in suspension culture such as in a bioreactor.” ([0069]). A bioreactor system comprises about 1 to about 1000 reaction chambers ([0135]), and the at least one reaction chamber has an internal volume of about 1 L to about 100,000 L ([0136]), including about 1,000 L to about 100,000 L ([0137]).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of Savir with the teachings of Elfenbein to cultivate the cultured animal cells in a bioreactor ranging from 1,000 L to 100,000 L to scale up the production of the cultured animal cells. One of ordinary skill in the art would have had a reasonable expectation of success in doing so because Elefenbein teaches that animal cells, including myoblasts, adipocytes, and differentiated embryonic stem cells can be cultivated in a bioreactor, including one with a capacity of about 1,000 L to about 100,000 L.
Additionally, changes in size or proportion/scaling do not patentably distinguish a claim from the prior art. See MPEP § 2144.04(IV)(A).
Claims 24-25 are therefore rendered obvious.
Response to Arguments
Claim Rejections – 35 U.S.C. § 103: Applicant’s arguments filed on 23 June 2026 have been fully considered, but they are not persuasive.
Applicant first argued that the Examiner’s characterization of Savir’s disclosure of heme proteins is inconsistent with Applicant’s express definition of an “exogenous heme-containing protein” because Savir merely discloses cultured animal cells that endogenously contain heme proteins, whereas amended claim 18 requires an exogenous heme-containing protein that is artificially added to the plant-based meat dough (p. 6, ¶ 6 – p. 7, 3).
Applicant’s argument has been considered, but it is not persuasive. Savir does not merely disclose cultured animal cells that endogenously contain heme proteins as asserted by Applicant. Savir teaches that heme proteins for the invention are cultured in various methods and various sources, including several types of cells that can differentiate into a variety of cell types ([0309]; see also [0050], [0322]) and that “cultured cells can be used in their native form in the hybrid foodstuff or treated or genetically engineered to enrich a certain trait/phenotype e.g., level of expression of HPs [i.e., heme proteins].” ([0312]).
Regarding “exogenous heme-containing protein”, the instant specification provides the following in paragraph [0056]:
The term "exogenous heme-containing protein" as used herein refers to a heme-containing protein that is artificially added to the plant-based meat dough. In some embodiments, the exogenous heme-containing protein is provided as an isolated ingredient. In some embodiments, the exogenous heme-containing protein is expressed as a recombinant protein in non-animal cells such as those from a yeast, fungi, algae, or plant. In some embodiments, the exogenous heme- containing protein is provided as part of another ingredient in the hybrid meat substitute product (e.g., in a complex extract or within cells that artificially express the heme-containing product). When provided within a cell, the exogenous heme-containing protein is 1) expressed in the cell from an exogenous gene (i.e., the protein does not exist in the wild type cells); and/or 2) is expressed at super physiological levels due to one or more genetic modification(s) to the cells (e.g., by adding extra copies of a gene encoding a heme-containing protein, or genetically engineering the gene loci encoding the native heme-containing protein for overexpression).
The teaching of Savir that cultured animal cells used in the hybrid foodstuff may be genetically engineered to enrich a level of expression of heme proteins is clearly in accordance with Applicant’s express definition of “exogenous heme-containing proteins” (i.e., “When provided within a cell, the exogenous heme-containing protein is…2) is expressed at super physiological levels due to one or more genetic modification(s) to the cells…”), and thus meets the requirement for an exogenous heme-containing protein.
Moreover, while Savir uses hepatocytes as an example cell type, the disclosure is not limited to hepatocytes, but includes various other cell types that can be engineered to increase heme protein expression.
MPEP § 2123(I) states, “‘The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.’ In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989).”
Therefore, Savir clearly teaches one of ordinary skill in the art that various cultured animal cell types can be genetically engineered to express heme proteins, meeting Applicant’s requirement for “an exogenous heme-containing protein”.
Applicant next argued that Savir does not teach, suggest, or motivate the additional limitations of between 0.10% and 1.0% by weight exogenous heme-containing protein and that the cultured animal cells and the exogenous heme-containing protein synergistically improve the meaty flavor of the hybrid meat substitute product (p. 7, ¶ 4 – p. 8, ¶ 2).
In response, Applicant is referred to the rejection of claim 18 presented hereinabove regarding how these newly claimed features are obvious in view of Savir. The Office maintains that Savir meets the requirement of “an exogenous heme-containing protein” per Applicant’s express definition, including that genetic engineering cells to increase expression of heme-containing proteins as disclosed in Savir constitutes “artificially adding” the exogenous heme-containing protein. To Applicant’s point that “Savir also teaches at least 50% of the cultured meat portion is cultured meat cells selected from a group consisting of heme-proteins.” (p. 7, last ¶), Savir teaches that “According to some embodiments of the invention, the cultured meat, cells and substances thereof is from about 0.5% to about 18% (w/w).” ([0044]), and “According to some embodiments of the invention, at least about 50% of cultured meat portion is cultured meat cells selected from a group consisting of heme-proteins (HPs), hepatocytes, myoblasts…and any combinations thereof.” ([0055]). Therefore, at least about 50% of the cultured meat portion may be heme proteins, alone or in combination with cultured animal cells. Applicant’s argument is therefore not persuasive.
Applicant next argued that Examples 4 and 5 of the instant specification demonstrate that endogenous heme proteins present within animal cells are not functionally equivalent to an exogenous heme-containing protein (p. 8, ¶¶ 3-6).
Applicant’s argument is moot in light of Savir teaching exogenous heme-containing proteins according to Applicant’s express definition and as claimed.
Applicant next argued that Savir does not recognize that separately adding an exogenous heme-containing protein in the claimed concentration range, together with cultured animal cells, would provide a synergistic improvement in meaty flavor, and thus a PHOSITA after reading Savir, would not be motivated to add between 0.10%-1.0% by weight exogenous heme containing protein in a hybrid meat substitute product (pp. 8-9, bridging ¶).
Applicant’s argument has been considered, but it is not persuasive. As described in the rejection of claim 18 hereinabove, the claimed range of between 0.10%-1.0% by weight exogenous heme containing protein is obvious in view of Savir.
As such, Savir discloses the claimed step of mixing the claimed ingredients in the claimed amounts. When the method steps recited in the prior art reference are substantially identical to those of the claims, claimed properties of the resulting composition are presumed to be present in the composition of the prior art. The burden of proof shifts to the applicant to provide objective evidence (i.e., test data) to the contrary. See In re Best, 562, F.2d 1252, 1254, 195 USPQ 403, 433 (CCPA 1977). MPEP § 2112.01(I). Additionally, as provided by MPEP § 2145(II), “[m]ere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979)”, and “‘[t]he fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.’ Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985)”.
Therefore, the property that the cultured animal cells and the exogenous heme-containing protein synergistically improve the meaty flavor of the hybrid meat substitute product is presumed to be present in the hybrid meat substitute of Savir, and recognition of this property cannot be the basis for patentability when the claim is otherwise obvious.
Regarding Applicant’s arguments concerning new claims 40-41 (p. 9, ¶ 3 – p. 10, ¶ 6), Applicant is referred to the rejections of claims 40 and 41 presented hereinabove regarding how these new claims are obvious in view of Savir.
Applicant further argued that claim 19 is allowable for at least the same reasons discussed with respect to amended claim 18, and Vrljic does not cure these deficiencies (p. 10, ¶ 7 – p. 12, ¶ 1).
In response, Applicant’s arguments regarding claim 18 are not persuasive, so neither is this argument regarding claim 19.
Applicant next argued that Savir provides no reason to replace hepatocytes with isolated heme-containing proteins as proposed in the rejection (p. 12, ¶¶ 3-4).
In response, the motivation for the substitution is provided by KSR as described in MPEP § 2143(I)(B), simple substitution of one known element for another to obtain predictable results. This being the case, motivation does not need to come from the reference. Applicant’s argument is therefore not persuasive.
Applicant’s arguments regarding new claims 27-41 in view of Savir and Vrljic (p. 12, ¶ 5 – p. 13, ¶ 3) are moot because these claims are rejected in view of Savir.
Applicant further argued that claims 24-25 are allowable for at least the same reasons discussed with respect to amended claim 18, and Elfenbein does not cure these deficiencies (p. 13, ¶ 4 – p. 14, ¶ 5).
In response, Applicant’s arguments regarding claim 18 are not persuasive, so neither is this argument regarding claims 24-25.
Applicant’s arguments regarding new claims 27-41 in view of Savir and Elfenbein (p. 14, ¶¶ 5-7) are moot because these claims are rejected in view of Savir.
Claims 18-41 are rejected under 35 U.S.C. § 103 as presented hereinabove.
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.
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/JAMES P. SHELLHAMMER/Examiner, Art Unit 1793
/ELIZABETH GWARTNEY/Primary Examiner, Art Unit 1759
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