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 with traverse of Group I (Claims 1 and 107-119) in the reply filed on 12 December 2025 is acknowledged. The traversal is on the ground(s) that a single search and examination covering all claims would not place undue burden on the examiner. This is not found persuasive because the examination of all claims would require different searches for each of the inventions and thus that would place undue burden on the examiner.
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claim 108 is objected to because of the following informalities: “the plasma” should read as “the non-human blood plasma” Appropriate correction is required.
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 and 107-112 are rejected under 35 U.S.C. 103 as being unpatentable over Forgacs et al. (herein referred to as Forgacs, US 20130029008 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, Forgacs teaches a cultivated meat product (abstract) comprising a fat replica ([0011] Forgacs reads such that the product may contain adipose cells) and a muscle replica ([0011] Forgacs reads such that the product contains layers of myocyte cells (cells that form muscle tissue). Forgacs teaches the product contains multiple layers which can contain the fat replica and the muscle replica ([0011]). Forgacs teaches that one can modify the fat replica and muscle replica to achieve the desired flavor texture, thickness, and appearance ([0037]). As such it would have been obvious to one with ordinary skill in the art to modify the ratio and the fat replica and muscle replica to achieve the desired flavor, texture, thickness, and appearance ([0037]).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).
Forgacs teaches advantages of the comestible meat products, layers, multicellular bodies, and methods of making the same disclosed herein include, but are not limited to, production of customized tissues in a reproducible, high throughput and easily scalable fashion while keeping precise control of pattern formation, particularly in cases of multiple cell types, which may result in engineered meat products with appealing flavor, texture, thickness, and appearance ([0037]). Forgacs teaches the product is scalable meaning the product can be made in a variety of sizes and quantities. One with ordinary skill in the art would recognize that size and quantity are directly correlated to the weight of the product. 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 Forgacs, including 10g as instantly claimed, to achieve the desired weight for the desired intent without losing the product’s appealing flavor, texture, thickness, and appearance.
However, Forgacs 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 Forgacs to reduce the cholesterol/saturated fat content of the meat product.
In addition, Forgacs teaches the multicellular bodies also include one or more extracellular matrix, such as fibrin, in addition to the plurality of cells ([0058]). But Forgacs 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).
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 Simsa because Forgacs teaches the use of non-human muscle cells and fibrin together without a carrier while Simsa teaches the use of non-human muscle cells and fibrin in a hydrogel (i.e., microcarrier). Simsa clearly teaches this method of using a hydrogel (i.e., microcarrier) was well known in the art before the effective filing date of the claimed invention and therefore would be a suitable for the same intended purpose (a meat product) as Forgacs. See MPEP 2144.07 and MPEP 2144.06(II).
With regard to Claim 107, 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.
With regard to Claim 108, Forgacs 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 Forgacs 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, Forgacs teaches the cells comprise pig cells ([0055])
With regard to Claim 110, Forgacs teaches the cells comprise chicken cells ([0055]).
With regard to Claim 111, Forgacs 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 Forgacs 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, Forgacs 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.
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 Brown et al. (herein referred to as Brown, WO 2013010042 A1)
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.
Brown teaches a plant based meat substitute which has properties similar to meat (Abstract). Brown teaches the product may contain hemoglobin recycled from the blood from a slaughter house ([00368]). One with ordinary skill in the art would recognize that in order to get hemoglobin it must be lysed from the red blood cells. Thus Brown reads such that the hemoglobin is lysate of non-human red blood cells. Brown teaches hemoglobin from the blood is used to enhance the color of a consumable ([00368]).
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 Brown to use hemoglobin (i.e., lysate of non-human red blood cells) to enhance the color of a consumable.
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), Brown (WO 2013010042 A1) 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), Brown (WO 2013010042 A1) 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARLA I DIVIESTI whose telephone number is (571)270-0787. The examiner can normally be reached Monday-Friday 7am-3pm (MST).
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/K.I.D./Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792