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 Claims
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1-26
Withdrawn claims: 1-17
Previously canceled claims: None
Newly canceled claims: None
Amended claims: 18 and 20
New claims: 21-26
Claims currently under consideration: 18-26
Currently rejected claims: 18-26
Allowed claims: None
Election/Restrictions
Applicant’s election without traverse of Group II, claims 18-26 in the reply filed on 10 February 2026 is acknowledged.
Claims 1-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10 February 2026.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 18, 20-23, and 26 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 ([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]).
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).
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.
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.
Conclusion
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/JAMES P. SHELLHAMMER/Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793