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 .
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 1 and 108-112 are rejected under 35 U.S.C. 103 as being unpatentable over Elfenbein et al. (herein referred to as Elfenbein, US 20200140821 A1) in view of Cox et al. (herein referred to as Cox, US 5219599 A) and Simsa et al (herein referred to as Simsa, “Extracellular Heme Proteins Influence Bovine Myosatellite Cell Proliferation and the Color of Cell-Based Meat”.)
With regard to Claim 1, Elfenbein teaches systems and methods for producing cell cultured food products (abstract). Elfenbein teaches the product comprises a fat replica ([0069] Elfenbein reads such that the product may contain adipose cells) and a muscle replica ([0069]). Elfenbein teaches the muscle and fat replicas are present together wherein the myocytes and adipocytes are combined at a ratio of at least 1:1, 2:1, 3:1, 4:1, 5:1, 6:1, 7:1, 8:1, 9:1, 10:1, 11:1, 12:1, 13:1, 14:1, 15:1, 16:1, 17:1, 18:1, 19:1, 20:1, 21:1, 22:1, 23:1, 24:1, 25:1, 26:1, 27:1, 28:1, 29:1, 30:1, 35:1, 40:1, 45:1, 50:1, 60:1, 70:1, 80:1, 90:1, or at least 100:1 ([0003], [0006], [0153]). 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).
With regard to the mass of the tissue, the culture method taught by Elfenbein produces a batch of cultured cells having at least a certain mass. Sometimes, the mass is measured as dry weight with excess media or supernatant removed. Usually, a bioreactor system produces a batch of cultured cells of about 1 kg to about 10,000 kg ([0141]). Elfenbein teaches after culturing the cells, they are harvested to produce a desired consistency and/or texture. In some cases, the harvested cells are processed to achieve particular tastes, textures and other culinary properties that are indistinguishable from the high-quality meats they are intended to reproduce ([0069]). One with ordinary skill in the art would recognize that size and quantity are examples of other culinary properties that would make the product indistinguishable from the meats they are intended to reproduce. 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 the size and quantity of the product taught by Elfenbein, including 10g as instantly claimed, to achieve the desired weight for the desired product.
However, Elfenbein is silent to the fat replica comprising a fat emulsion and hydrogel comprising non-human blood plasma.
Cox teaches a meat product with substantially less cholesterol as a result for substituting natural adipose for an artificial adipose (abstract). Cox teaches the artificial adipose comprises a fat emulsion and a hydrogel comprising crosslinked non-human blood plasma. (col 4. Lines 11-25 col 5 lines 15-33, Col 6 lines 26-61).
It would have been obvious to one with ordinary skill in the art to substitute the artificial adipose taught by Cox, which comprises a fat emulsion and a hydrogel comprising crosslinked non-human blood plasma, for the adipose cells used by Elfenbein to reduce the cholesterol/saturated fat content of the meat product.
In addition, Elfenbein teaches the use of microcarriers and scaffolding ([0037], [0225]). But Elfenbein is silent to the muscle replica comprising a microcarrier comprising fibrin.
Simsa teaches a cultivated meat product (1. Introduction, page 1). Simsa teaches microcarriers comprising fibrin (1. Introduction, page 2). The microcarriers (i.e., hydrogels) were used to grow cells for tissue formation (1. Introduction, page 2). Simsa teaches myosatellite cells (muscle cells) can be harvested and then grown in 3D to form bioartificial muscle constructs by growth in hydrogels (1. Introduction, page 2). Simsa teaches three-dimensional growth of skeletal muscle in hydrogels along agarose pillars was the basis of the first demonstration of a cell-based meat prototype (1. Introduction, page 2).
Therefore, Simsa imparts reasoning for obviousness because the teaching shows that the claimed fibrin microcarrier was known for such a thiung to have been successfully achieved and published at the time of filing, which means it was within the general skill of one with ordinary skill in the art to select a fibrin microcarrier for myocyte cell growth because it would be obvious to one of skill in the art to do such a thing 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 108, Elfenbein is silent to the plasma comprising crosslinked fibrinogen.
Cox teaches the artificial adipose comprises crosslinked non-human blood plasma. (col 4. Lines 11-25 col 5 lines 15-33, Col 6 lines 26-61). Cox teaches fibrinogen within in the plasma is crosslinked and the fat is captured in interstices of the complex cross-linked (Col 11 lines 14-16). Cox teaches the fibrinogen and albumin fractions of blood plasmas are both reactionable proteins, making the plasma a superb emulsificant for oils or fats added later to produce artificial adipose tissue (Col 11 lines 40-43).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Elfenbein in view of Cox to utilize cross-linked fibrinogen to capture the fat within the interstices of the cross-linked complex and the fibrinogen is a superb emulsificant for oils or fats added later to produce artificial adipose tissue.
With regard to Claim 109, Elfenbein teaches the cells may comprise pig cells ([0127])
With regard to Claim 110, Elfenbein teaches the cells comprise chicken cells ([0127], [0150]),.
With regard to Claim 111, Elfenbein is silent to the fat replica comprising a fat emulsion comprising animal fat.
Cox teaches a meat product with substantially less cholesterol as a result for substituting natural adipose for an artificial adipose (abstract). Cox teaches the artificial adipose comprises a fat emulsion and a hydrogel comprising crosslinked non-human blood plasma. (col 4. Lines 11-25 col 5 lines 15-33, Col 6 lines 26-61). Cox teaches the fat emulsion can contain virtually any fat, edible oil, or other lipid or fat or oil substitute such as animal fat (Col 6 lines 20-26).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Elfenbein in view of Cox to use a fat emulsion that contains animal fat to reduce the cholesterol/saturated fat content of the meat product.
With regard to Claim 112, Elfenbein is silent to the fat replica comprising a fat emulsion comprising a plant-based fat.
Cox teaches a meat product with substantially less cholesterol as a result for substituting natural adipose for an artificial adipose (abstract). Cox teaches the artificial adipose comprises a fat emulsion and a hydrogel comprising crosslinked non-human blood plasma. (col 4. Lines 11-25 col 5 lines 15-33, Col 6 lines 26-61). Cox teaches the fat emulsion can contain virtually any fat, edible oil, or other lipid or fat or oil substitute such as vegetable oil (Col 6 lines 20-26).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Forgacs in view of Cox to use a fat emulsion that contains a plant-based fat (i.e., vegetable oil) to reduce the cholesterol/saturated fat content of the meat product.
Claim 107 is rejected under 35 U.S.C. 103 as being unpatentable over Elfenbein (US 20200140821 A1) in view of Cox (US 5219599 A), Simsa et al ( “Extracellular Heme Proteins Influence Bovine Myosatellite Cell Proliferation and the Color of Cell-Based Meat”.) , and Forgacs et al. (herein referred to as Forgacs, US 20130029008 A1).
With regard to Claim 107, Elfenbein teaches after culturing the cells, they are harvested to produce a desired consistency and/or texture. In some cases, the harvested cells are processed to achieve particular tastes, textures and other culinary properties that are indistinguishable from the high-quality meats they are intended to reproduce ([0069]). But Elfenbein is silent to the tissue mass being a ground beef replica.
Forgacs teaches the engineered meat products are produced, packaged, frozen, stored, distributed, marketed, advertised, and sold as, for example, food products for human beings, components or ingredients of food products for human beings, food products for non-human animals, or components or ingredients of food products for non-human animals ([0048]). Forgacs teaches in some embodiments, the shape of a meat product is selected to resemble a traditional meat product such as a hamburger patty or a meatloaf. In other embodiments, the engineered meat products are ground ([0118]). One with ordinary skill in the art would recognize that a hamburger patty and meat loaf are both produced traditionally with ground beef. Therefore, because the product taught by Forgacs can be ground and is used to replicate products made utilizing ground beef than one with ordinary skill in the art would recognize the product taught by Forgacs is a ground beef replica.
Therefore, Simsa imparts reasoning for obviousness because the teaching shows that the claimed fibrin microcarrier was known for such a thiung to have been successfully achieved and published at the time of filing, which means it was within the general skill of one with ordinary skill in the art to select a fibrin microcarrier for myocyte cell growth because it would be obvious to one of skill in the art to do such a thing 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.
Claims 113-115 and 117-118 are rejected under 35 U.S.C. 103 as being unpatentable over Simsa ( “Extracellular Heme Proteins Influence Bovine Myosatellite Cell Proliferation and the Color of Cell-Based Meat”.) in view of Cox (US 5219599 A) and Antipova et al. (herein referred to as Antipova, RU 2126215 C1)
With regard to Claim 113, Simsa teaches a cultivated meat product (1. Introduction, page 1). Comprising microcarriers comprising fibrin (1. Introduction, page 2) and non-human cells (2.1. Bovine Satellite Cell Isolation and Cell Culture).
Simsa teaches the size of constructs depends largely on initial cell number, scaffold volume, and cultivation method (4. Discussion). Simsa teaches larger constructs can be made with different approaches, such as specialized bioreactors, cell-sheet stacking, 3D bioprinting
or coculture systems with endothelial cells (4. Discussion). Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention that the product taught by Simsa can be made in any desirable size and can be modified based on the numerous factors such as the cultivation method.
Simsa is silent to the product comprising a fat emulsion and non-human blood plasma.
Cox teaches a meat product with substantially less cholesterol as a result for substituting natural adipose for an artificial adipose (abstract). Cox teaches the artificial adipose comprises a fat emulsion and a hydrogel comprising crosslinked non-human blood plasma. (col 4. Lines 11-25 col 5 lines 15-33, Col 6 lines 26-61).
It would have been obvious to one with ordinary skill in the art to modify Simsa in view of Cox to utilize the artificial adipose taught by Cox, which comprises a fat emulsion and a hydrogel comprising crosslinked non-human blood plasma, to reduce the cholesterol/saturated fat content of the meat product.
Continuing, Simsa is silent to the cultivated meat product containing a lysate of non-human red blood cells.
Antipova teaches a method for obtaining a food semi-finished product from the blood of slaughtered animals ([0007]). Antipova teaches To achieve uniform coloring of blood products and increase their biological value, the cell walls of red blood cells are first destroyed, causing hemoglobin to transition from bound to free form and be evenly distributed throughout the system ([0010]). Antipova teaches carrying out hemolysis in order to destroy the stromal membranes of cells and increase the attack-ability of proteins by digestive enzymes in the gastrointestinal tract ([0010]). Antipova teaches the hemolysis product ensures further coloration of the finished product and high consumer appeal.
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Simsa in view of Antipova to utilize a hemolysis product (i.e., lysate from red blood cells) to ensures further coloration of the finished product and high consumer appeal.
With regard to Claim 114, Simsa teaches using myosatellite cells which as muscle progenitor cells that have a greater capacity to proliferate and differentiate (1. Introduction page 2). Simsa teaches differentiation of myosatellite cells into adult muscle tissue can be initiated by changing the media conditions, topographical cues, electrical or mechanical stimuli, or other modes (1. Introduction page 2). One with ordinary skill in the art would recognize that a myosatellite cells differentiates into a myoblast. Therefore, it would have been obvious to one with ordinary skill in the art to changing the media conditions, topographical cues, electrical or mechanical stimuli to differentiate the myosatellite cells into adult muscle tissue (i.e., myoblast).
With regard to Claim 115, Sima is silent to the fat emulsion comprising adipose cells.
Cox teaches a meat product with substantially less cholesterol as a result for substituting natural adipose for an artificial adipose (abstract). Cox teaches the artificial adipose comprises a fat emulsion (col 4. Lines 11-25 col 5 lines 15-33, Col 6 lines 26-61). Cox teaches the fat emulsion can contain virtually any fat, edible oil, or other lipid or fat or oil substitute such as animal fat (Col 6 lines 20-26). One with ordinary skill in the art would recognize that animal fat would inherently contain adipose cells.
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Simsa in view of Cox to use a fat emulsion that contains animal fat (i.e., adipose cells) to reduce the cholesterol/saturated fat content of the meat product.
With regard to Claim 117, Simsa teaches the microcarrier comprises a polymer (abstract, Simsa reads such that the microcarrier is a hydrogel).
With regard to Claim 118, Simsa teaches the hydrogel (i.e., microcarrier) comprises fibrin (1. Introduction, page 2). One with ordinary skill in the art would recognize that fibrin is a protein and thus Simsa reads such that the microcarrier comprises a protein.
Claim 116 is rejected under 35 U.S.C. 103 as being unpatentable over Simsa ( “Extracellular Heme Proteins Influence Bovine Myosatellite Cell Proliferation and the Color of Cell-Based Meat”.) in view of Cox (US 5219599 A), Antipova (RU 2126215 C1) and Woerner et al. (herein referred to as Woerner, US 20170339989 A1)
With regard to Claim 116, Simsa is silent to the product comprising non-human blood plasma.
Cox teaches the artificial adipose comprises a hydrogel comprising crosslinked non-human blood plasma. (col 4. Lines 11-25 col 5 lines 15-33, Col 6 lines 26-61). Cox teaches the non-human blood plasma contains fibrinogen (Col 8 lines 9-17). One with ordinary skill in the art would recognize that fibrin is the insoluble form of fibrinogen.
However, the combination of Simsa and Cox is silent to the non-human blood plasma comprising fibrin.
Woerner teaches methods of producing meat compositions with reduced salt content (abstract). Woerner teaches using cold binding to bind together sections of meat muscle to create a whole raw meat product into a desired shape, using separate muscles to create a uniform mass ([0006]). Woerner teaches cold-binding agents which are currently known and will be developed may be used in the present system. An example is fibrinogen and thrombin, plasma components that when combined, produce fibrin that binds meat tissue. When referring here to fibrin as a cold-binding agent is also intended to include where the meat is contacted with fibrinogen and thrombin to result in fibrin formation ([0008]).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Simsa and Cox to include non-human blood plasma comprising fibrin as taught by Woerner to act as a binder to bind together sections of meat muscle.
Claim 119 is rejected under 35 U.S.C. 103 as being unpatentable over Simsa ( “Extracellular Heme Proteins Influence Bovine Myosatellite Cell Proliferation and the Color of Cell-Based Meat”). in view of Cox (US 5219599 A), Antipova (RU 2126215 C1) and Gomez-Florit et al. (herein referred to as GF, “Natural-Based Hydrogels for Tissue Engineering Applications”).
With regard to Claim 119, Simsa teaches the microcarrier is a hydrogel (1. Introduction, page 2) but is silent to the microcarrier comprising a plant base material.
GF teaches in the field of tissue engineering hydrogels are used as biomaterials to support cell attachment and promote tissue regeneration due to their unique biomimetic characteristics (abstract). GF teaches the natural materials can be used to conduct multiple structural and biological functions due to their outstanding range of macromolecular designs (1. Natural Polymers in Tissue Engineering). GF teaches natural materials include materials that originated from plants and advantages include higher biocompatibility and can show fibrillar architecture, mimicking the native tissues’ extracellular matrix (1. Natural Polymers in Tissue Engineering).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify the hydrogel taught by Simsa to comprise a plant-based material as taught by GF to have a higher biocompatibility and mimicking the native tissues’ extracellular.
Response to Arguments
Applicant’s arguments, filed 14 July 2026, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Elfenbein et al. (herein referred to as Elfenbein, US 20200140821 A1), Cox et al. (herein referred to as Cox, US 5219599 A) and Simsa et al (herein referred to as Simsa, “Extracellular Heme Proteins Influence Bovine Myosatellite Cell Proliferation and the Color of Cell-Based Meat”.)
The objection to claim 108 has been withdrawn in response to the amendments made 154 July 2026.
First, applicant argues that Forgac’s expressly teaches away from the use of scaffolds. The applicant points to paragraph [0009] of Forgacs which states “The engineered meat does not include any filler bodies, such as may be found in other forms of engineered tissues. For example, filler bodies that act as scaffolding (e.g., support structures) are not necessary, and may be detrimental to the final comestible product”. This argument was found to be persuasive. Forgac’s is no longer relied upon in the rejection. Any further arguments with regard to Forgac are moot in view of the new grounds of rejection.
Further, with regard to claims 113-115 and 117-118 applicant argues that one with ordinary skill in the art would not have been motivated to modify the cultivated meat product taught by Simsa with the hemoglobin reported in Brown. Applicant argues that Simsa expressly teaches that myoglobin has more beneficial outcomes on proliferation and meat coloring than hemoglobin. In this case, because the claim in focused on the product and not the culturing of the cells, the proliferation has would have no effect on the product because the cells are far past the proliferation stage when being incorporated into the product. Thus, we are focusing on the effect of hemoglobin on the final meat product not cell proliferation. As a result, because Brown teaches the hemoglobin used to enhance the color of a consumable (Brown, [00368]), then one with ordinary skill in the art would still be motivated to utilize the hemoglobin as taught by Brown to achieve the desired color of the final product. Therefore, applicant’s argument is not found to be persuasive.
Next, applicant argues that Brown does not teach the use of lysate of red blood cells. Applicant argues that the lysate includes more than the hemoglobin as taught by Brown. Applicant’s arguments have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Simsa Cox, and Antipova. In this case, Antipova is now relied upon to teach the claimed lysate of red blood cells.
Conclusion
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/K.I.D./Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792
