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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-11 and newly added claims 21-27) in the reply filed on 27 August 2025 is acknowledged.
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 1-11, 21-22, and 24-27 are rejected under 35 U.S.C. 103 as being unpatentable over Ajami et al. (herein referred to as Ajami, US 20170105438 A1) in view of Savir et al. (herein referred to as Savir, US 20200100525 A1).
With regard to Claim 1, Ajami teaches food products that have structures, textures, and other properties comparable to those of animal meat, and that may therefore serve as substitutes for animal meat. Also provided are processes for production of such ground meat-like food products (abstract). Ajami teaches forming an emulsion containing an oil and a hydrocolloid ([0158], [0162], [0164]). Ajami teaches the emulsion can include cell wall materials ([0190]). Ajami teaches adding a hydration mixture to a textured protein ([0106], Example 2, [0276]), thus forming a hydrated textured subcomponent. Ajami teaches contacting the hydrated textured subcomponent with the emulsion mixture to produce a food product and forming the product into a patty (Example 5 [0298]-[0299]).
However, although Ajami teaches the emulsion of step a can include cell wall materials, the reference is silent to the emulsion containing a hydrated cell mass.
Savir teaches a cultured meat-containing hybrid food ([0001]). Savir teaches utilizing cultured animal cells to enhance a meat organoleptic and/or mean nutritional property in the hybrid foodstuff (abstract, [0066]). Savir teaches adding the cultured animals cells to oil and a hydrocolloid ([0362]).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Ajami in view of Savir to include cultured animal cells (i.e., hydrated cell mass) to enhance a meat organoleptic and/or mean nutritional property in the hybrid foodstuff. Savir teaches the cells are produced in a suspension culture ([0171]) meaning the cell mass would be hydrated.
With regard to Claim 2, Ajami is silent to the hydration mixture further comprises a hydrated second cell mass.
Savir teaches an embodiment wherein a cell mass is added to an emulsion mixture (step a) as well as adding a cell mass to a hydration mixture ([0357], [0360]) Savir teaches utilizing cultured animal cells to enhance a meat organoleptic and/or mean nutritional property in the hybrid foodstuff (abstract, [0066]).
Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Ajami in view of Savir to include a cell mass in the hydration mixture because Savir shows cell mass has been successfully used in a hydration mixture for producing a cell-based food product and published at the time of filing, which means it was within the skill of one with ordinary skill in the art to add a cell mass to the hydration mixture on the basis of its suitability for a similar intended use. See MPEP 2144.07 that discussed that when the prior art recognizes something is suitable for a similar intended use/purpose, such a thing is obvious. In addition, it would be advantageous to include the cell mass in the hydration mixture to enhance a meat organoleptic and/or mean nutritional property in the hybrid foodstuff.
With regard to Claim 3, Ajami is silent to the hydrated first and second cell masses comprising non-human cells harvested from one or more suspension cultures.
Savir teaches the non-human cells are produced in a suspension culture ([0148], [0171]).
Savir imparts reasoning for obviousness because the teaching shows suspension cultures were known to have been successfully used in a method to produce a cell-based food product and published at the time of filing, which means it was within the skill of one with ordinary skill in the art to select the use of suspension culture on the basis of its suitability for a similar intended use. See MPEP 2144.07 that discussed that when the prior art recognizes something is suitable for a similar intended use/purpose, such a thing is obvious.
With regard to Claim 4, Ajami is silent to the hydrated first cell mass comprising poultry cells having phenotypes of fibroblasts, myofibroblasts, and myogenic cells, or a combination thereof.
Savir teaches the cultures cells are from domesticated animals such as chicken ([0166]) and include fibroblasts ([0055]).
Savir imparts reasoning for obviousness because the teaching shows fibroblasts from poultry cells were known cultured cells to have been successfully used in a food product and published at the time of filing, which means it was within the skill of one with ordinary skill in the art to select poultry cells with the phenotype fibroblast on the basis of its suitability for a similar intended use. See MPEP 2144.07 that discussed that when the prior art recognizes something is suitable for a similar intended use/purpose, such a thing is obvious.
With regard to Claim 5, Ajami teaches the term “controlled conditions” which refers to conditions that are defined by a human, such as, for example, level of oxygenation, pH, salt concentration, temperature, and nutrient (e.g., carbon, nitrogen, sulfur) availability. A non-animal source grown under controlled conditions may produce a distribution of protein, carbohydrate, lipid, and other compounds that are not native to the non-animal source ([0037]).
Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to utilize desired controlled conditions, such as temperature, to achieved or maintain the desired properties of the hydrated cell mass. See MPEP 2144.05(II)(A) "[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).
With regard to Claim 6, Ajami teaches the use of controlled conditions. Controlled conditions is defined by conditions that are defined by a human, such as, for example, level of oxygenation, pH, salt concentration, temperature, and nutrient (e.g., carbon, nitrogen, sulfur) availability. A non-animal source grown under controlled conditions may produce a distribution of protein, carbohydrate, lipid, and other compounds that are not native to the non-animal source ([0037]).
It would be obvious to one with ordinary skill in the art to control the temperature of the cell mass prior to forming to achieve the desired properties during processing.
With regard to Claim 7, Ajami teaches the oil is present in an amount of about 30% and about 85%, between about 40% and about 70%, between about 50% and about 60%, or at least about 50% by weight of lipid. In some such embodiments, the emulsions comprise oils in amounts of between about 1% and about 50%, between about 3% and about 40%, between about 5% and about 20%, between about 5% and 10%, between about 5% and about 40%, between about 5% and about 60%, or between about 10% and about 30% by weight of the emulsion mixture ([0162]). See MPEP 2144.05(I) In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.
With regard to Claim 8, Ajami teaches the oil can be soybean oil as well as other oils cited in paragraph 0162 ([0162]).
With regard to Claim 9, Ajami teaches the hydrocolloids is present in an amount between about 0.1% to about 10.0%, between about 0.5% to about 8.0%, between about 2% and about 4%, or between about 1.5% to about 6.5% by weight of the emulsion ([0164]). See MPEP 2144.05(I) In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.
With regard to Claim 10, Ajami teaches the hydrocolloid can be locust bean gum and guar gum as well as other hydrocolloids shown listed in paragraph 164. ([0164]).
With regard to Claim 11, Ajami teaches freezing the food product either in uncooked, partially cooked, or cooked state ([0104]).
However, Ajami is silent to coating the frozen food product with batter and breading.
Savir teaches an embodiment wherein a cell-based food product is coated with batter and breading prior to being frozen ([0376]-[0385]). Per MPEP 2144.04(IV)(C) See In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results);.
Therefore, in the absence of new or unexpected results, Savir imparts reasoning for obviousness because the teaching shows coating a cell-based food product with batter and breading was known to have been successfully utilized and published at the time of filing, which means it was within the skill of one with ordinary skill in the art to coat a cell-based food product with batter and breading on the basis of its suitability for a similar intended use. See MPEP 2144.07 that discussed that when the prior art recognizes something is suitable for a similar intended use/purpose, such a thing is obvious. The examiner would like to the note that the claim does not limit the order in which the freezing and coating steps are to be performed. Thus, as explained above, Savir reads on the claimed limitations.
With regard to Claim 21, Ajami teaches the emulsion comprises oil in amounts of between about 1% and about 50% by weight ([0162]) and a hydrocolloid in an amount about 0.1% to about 10.0% by weight ([0164]). Ajami teaches the dispersed system components of the agent release systems comprised in the meat-like food products provided may be cell wall materials, wherein the dispersed system is part of the emulsion ([0190]) In addition, Ajami teaches a variety of ingredients in varying quantities can be added to the emulsion to enhance taste, flavor, aroma, and nutrition of the meat-like product to resemble a meat product ([0165]-[0168]).
Savir teaches utilizing cultured animal cells to enhance a meat organoleptic and/or meat nutritional property in the hybrid foodstuff (abstract, [0066]).
Savir shows that cultured animals cells function to enhance a meat organoleptic property when used in an emulsion. See MPEP 2144.06 discusses combining or substituting equivalents known for the same purpose. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.
Therefore it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Ajami in view of Savir to substitute cultured animals cells in place of the cell wall material in an amount sufficient to achieve the desired properties to enhance a meat organoleptic property (i.e., enhance taste, flavor, aroma, and nutrition) in the hybrid foodstuff because, as stated in the rationale above, the cell wall material and cultured animal cells act as equivalents known for the same purpose.
With regard to Claim 22, Ajami is silent to the food product comprising at least 35% by weight cell mass.
Savir teaches utilizing cultured animal cells to enhance a meat organoleptic and/or mean nutritional property in the hybrid foodstuff (abstract, [0066]). Savir teaches adding the cultured animals cells in an amount of 0.3% to about 30% (w/w) ([0017]). See MPEP 2144.05(I) A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985)
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Ajami in view of Savir to include a cell mass in an amount which would achieved the desired properties to enhance a meat organoleptic and/or meat nutritional property in the hybrid foodstuff.
With regard to Claim 23, Ajami teaches characterizing the food product in view of its “doneness”. Ajami teaches the term “doneness” as used herein refers to a state in which a meat-like food product as provided herein after heating has obtained one or more similar or superior meat-like attributes compared to cooked animal meat (e.g., rare cooked animal meat, medium cooked animal meat, well done cooked animal meat). Specifically, a food product is “done” when compared to cooked animal meat if it has obtained similar or superior color, aroma, taste, chewiness, gumminess, springiness, cohesiveness, resilience, adhesiveness, hardness, MC, juiciness, internal temperature, cook loss, or head space GCMS ([0044]). Specifically, Ajami teaches the food product has a hardness of between about 1000 g and about 6000 g ([01217], see applicant specification paragraph [0070]). Ajami teaches variables that can be titrated to modulate the hardness of the meat-like food products provided herein include but are not limited to lipid content, structured protein products with different densities, MC, and binding agents with different viscoelastic properties, and pH ([0055]).
It would have been obvious to one with ordinary skill in the art that through routine optimization to modify variable such as lipid content, structured protein products with different densities, MC, and binding agents with different viscoelastic properties, and pH in order to achieve the desired harness of the food product. See MPEP 2144.05(I) which states a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) and MPEP 2144.05(II)(A) which states "[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).
With regard to the water activity Ajami teaches the term “moisture content” refers to the amount of water in a food product calculated as percentage change in mass following the evaporation of water from a sample. Variables that can be titrated to modulate the MC of the meat-like food products provided herein include but are not limited to humectant content (e.g., sorbitol), structured protein products with different water absorbing characteristics, lipid content, and/or binding agents with different water retention characteristics ([0068]). Per the applicants specification paragraph 29, the moisture content of the food product is indicated by the water activity.
Therefore, because Ajami teaches a method of calculating the moisture content (i.e., evaporation of water from a sample) and
With regard to Claim 24, Ajami teaches the food product comprises an emulsion in an amount of 1% to about 40% (Claims 16 and 19), a hydration mixture in an amount of 22.77% to 40% by weight (Table 7), texture protein in an amount of 30 to about 55% by weight (Claim 72), and a dry blend in the amount of 1.91% to 5.17% by weight (Table 7). See MPEP 2144.05 In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.
With regard to Claim 25, Ajami is silent to the packed cell volume and water content of the first hydrated cell mass.
Savir teaches culture the cells in a suspension culture ([0171]) and culturing the cells to a desired density ([0189]).
One with ordinary skill in the art would recognize the density of a culture is directly related to the cultures packed cell volume and water content. Therefore, it would have been obvious to one with ordinary skill in the art to optimize the cultures growing conditions through routine experimentation to achieve the desired culture density (i.e., packed cell volume and water content) for the downstream application in the cell-based food product. See MPEP 2144.05(II)(A) "[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).
With regard to Claim 26, Ajami teaches the food product comprises water in an amount of 22.77% to 40% by weight (Table 7). Ajami teaches dry taste agents in an amount of about 1.82% to 5% by weight (table 7). Ajami teaches taste agents include multiple types of salts including sodium chloride ([0090]). In addition to the taste agent, Ajami teaches taste enhancers which are compounds that enhances the activity of taste agents or increases the sensitivity of taste-receptors in the gustatory system ([0090]). One with ordinary skill in the art would recognize a taste enhancer is equivalent to a flavor agent and one could include the taste enhancer in an amount which achieved the desired taste result and more than one taste enhancer to achieve the desired result. See MPEP 2144.05(II)(A) "[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).
Continuing, Ajami teaches the food product contains at least about 25% by weight of one or more meat structured protein products ([0113]) wherein some embodiments comprise two or more meat structured protein products having different attributes such as different color, aroma, taste, protein content, lipid content, carbohydrate content, edible fiber content, protein type, lipid type, carbohydrate type, edible fiber type, MC, pH, percentage of protein fibers that are substantially aligned, TPA parameters, diameter, and length. ([0114]). Ajami teaches the two or more meat structured protein products having different attributes are present in different proportions in the meat-like food products ([0114]). Therefore, one with ordinary skill in the art would reasonably deduce to include a first, second, and third textured protein with the desired attributes in amounts in which would achieve the desired characteristics in the final food product.
Ajami teaches an emulsion containing an oil ([0162]) and a hydrocolloid ([0164]) wherein the emulsion comprise oils in amounts of between about 1% and about 50% ([0162]) and the emulsion comprises between about 0.1% to about 10.0% by weight of the hydrocolloid ([0164]). The emulsion is present in the food product in an amount of about 1-40% by weight (Claims 16 and 49). See MPEP 2144.05(I) In the case where the claimed ranges "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).
However, Ajami is silent to the first and second cell mass.
Savir teaches a cultured meat-containing hybrid food ([0001]). Savir teaches utilizing cultured animal cells to enhance a meat organoleptic and/or mean nutritional property in the hybrid foodstuff (abstract, [0066]).Savir teaches the utilization of multiple cell masses in the food product ([0055]).
Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Ajami in view of Savir to include and first and second cell mass in an amount in which the food product has the desired meat organoleptic and/or mean nutritional properties.
With regard to Claim 27, Ajami is silent to the second cell mass comprising a second population of cultured poultry cells.
Savir teaches the cultures cells are from domesticated animals such as chicken ([0166]) and more than one cell mass maybe be utilized in a cell-based food product ([0055]).
Therefore, Savir imparts reasoning for obviousness because the teaching shows poultry cells were known cultured cells to have been successfully used in a food product and published at the time of filing and it was known to utilize two cell mass in a cell-based food product, which means it was within the skill of one with ordinary skill in the art to select poultry cells for the second cell mass on the basis of its suitability for a similar intended use. See MPEP 2144.07 that discussed that when the prior art recognizes something is suitable for a similar intended use/purpose, such a thing is obvious.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Ajami (US 20170105438 A1) in view of Savir (US 20200100525 A1) and Zotter et al. (herein referred to a Zotter, WO 2021248047 A1)
With regard to Claim 23, Ajami teaches characterizing the food product in view of its “doneness”. Ajami teaches the term “doneness” as used herein refers to a state in which a meat-like food product as provided herein after heating has obtained one or more similar or superior meat-like attributes compared to cooked animal meat (e.g., rare cooked animal meat, medium cooked animal meat, well done cooked animal meat). Specifically, a food product is “done” when compared to cooked animal meat if it has obtained similar or superior color, aroma, taste, chewiness, gumminess, springiness, cohesiveness, resilience, adhesiveness, hardness, MC, juiciness, internal temperature, cook loss, or head space GCMS ([0044]). Specifically, Ajami teaches the food product has a hardness of between about 1000 g and about 6000 g ([01217], see applicant specification paragraph [0070]). Ajami teaches variables that can be titrated to modulate the hardness of the meat-like food products provided herein include but are not limited to lipid content, structured protein products with different densities, MC, and binding agents with different viscoelastic properties, and pH ([0055]).
It would have been obvious to one with ordinary skill in the art that through routine optimization to modify variable such as lipid content, structured protein products with different densities, MC, and binding agents with different viscoelastic properties, and pH in order to achieve the desired harness of the food product. See MPEP 2144.05(I) which states a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) and MPEP 2144.05(II)(A) which states "[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).
However, Ajami is silent to the water activity of the food product.
Zotter teaches food products resembling whole muscle meat and seafood (title). Zotter teaches water activity is a measure of free or unbound water in a food product ([0138]). Zotter teaches the water activity of a hydrocolloid gel may influence its physical properties and thus its cooking behavior, including its melting temperature ([0138]) Zotter teaches the water activity of raw animal meat is typically between 0.97 and 0.99. In another embodiment, the water activity level of a plant-based meat analog, including a plant- based bacon is at least 0, at least 0.1, at least 0.2, at least 0.3, at least 0.4, at least 0.5, at least 0.6, at least 0.7, at least 0.8, at least 0.9 or at least 1.0 ([0206]-[0207]).
Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Ajami to include the water activity as taught by Zotter to include the desired water activity to influence the physical properties of the food product.
Conclusion
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/K.I.D./Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792