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 claims 1, 86-96, and 105-108 in the reply filed on September 24, 2025 is acknowledged. The traversal is on the ground(s) that search would not place undue burden on the examiner. This is not found persuasive because the basis for restriction was Unity of Invention and the corresponding technical feature does not make a contribution over the prior art. Additionally, search burden is not the basis for restriction in a 371 application.
Claims 97-104 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claim 106 is objected to because of the following informalities: “the non-human blood plasma protein arise from a cell culture” should read “the non-human blood plasma protein arises from a cell culture”. Appropriate correction is required.
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 1, 86-96, and 105-108 are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Arye et al. (WO 2019/016795 A1) in view of Rajangam et al. (Fibrinogen and fibrin based micro and nano scaffolds incorporated with drugs, proteins, cells, and genes for therapeutic biomedical applications, International Journal of Nanomedicine).
With respect to Claim 1, Ben-Ayre et al. teaches an edible composition comprising myotubes [006] described as a cultured meat for food consumption [057], wherein the invention uses non-human satellite cells. [008] The invention of Ben-Ayre et al. comprises a three-dimensional porous scaffold, incubated with a plurality of cell types in order to induce differentiation into edible cells, [009] wherein the three-dimensional porous scaffold can be derived from non-textured protein [020] and the plurality of cell types are non-human cells from a livestock mammal. [021] Additionally, Ben-Ayre et al. teaches that the scaffold can comprise pores with an average diameter between 20-1,000 um, [020] and can be an animal protein such as collagen. [0101]
The composition of Ben-Ayre et al. reads on a meat product comprising a plurality of microcarrier scaffolds with an average diameter of less than 1mm and non-human animal cells present on the scaffolds, but is silent to the scaffold comprising at least 50% non-human blood plasma protein.
Rajangam et al. teaches the composition and function of a variety of micro and nano structures, specifically with regard to their ability to facilitate tissue growth in conjunction with stem cells, protein, and growth factors. [Abstract] Rajangam et al. teaches that some common biomimetic scaffolds can comprise gelatin, collagen, fibrinogen and fibrin [Pg. 3641, Par. 2] and that the fibrinogen can be derived from bovine. [Pg. 3650, Col. 2, Par. 2]. Additionally, Rajangam et al. teaches that fibrinogen is a blood protein involved in coagulation and, when mixed with thrombin and Ca---2+, form fibrin. [Pg. 3641, Par. 2] Rajangam et al. teaches the scaffolds can come in a variety of forms that can be optimized for size, shape, and porosity depending on the preferred cell culture. [Pg. 3643, Col. 1, Par. 2]
Rajangam et al. teaches a hydrogel scaffold consisting of fibrinogen and thrombin in the presence of Ca2+, and that the pore size of the hydrogel can be controlled by controlling the concentration of thrombin in the solution. [Pg. 3646, Col. 2, Par. 2] It is well-known in the field of endeavor that fibrinogen and thrombin are proteins that exist in blood plasma. Therefore, the hydrogel scaffold consisting of fibrinogen and thrombin in the presence of Ca2+ taught by Rajangam et al. reads on a microcarrier scaffold comprising at least 50% non-human blood plasma protein.
Ben-Ayre et al. and Rajangam et al. exist within the same field of endeavor in that they teach microcarrier scaffolds and their function. Where Ben-Ayre et al. teaches the use of microcarrier scaffolds for culturing meat products for food, Rajangam et al. teaches a variety of microcarrier scaffold compositions comprising the blood plasma protein fibrinogen. Rajangam et al. teaches that the scaffolds made from fibrinogen can be optimized to serve many functions and are excellent for growing organs and tissues by using stem cells and growth factors. Using the teaching of Ben-Ayre et al. of using an animal protein, specifically from a livestock mammal, and the teaching of Rajangam et al. of a fibrinogen microcarrier scaffold, it would have been obvious to one of ordinary skill to use a fibrinogen scaffold comprising non-human blood plasma protein.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to have used the teaching of Ben-Ayre et al. in conjunction with the teaching of Rajangam et al. to produce a culture meat product, comprising a plurality of microcarrier scaffolds with an average diameter of less than 1mm, comprising at least 50% non-human blood plasma proteins and non-human cells on the scaffold, thereby rendering claim 1 obvious.
With respect to Claim 86, Ben-Ayre et al. in view of Rajangam et al. renders obvious the invention recited in claim 1. Additionally, Ben-Ayre et al. teaches that the composition is edible. [006]
With respect to Claim 87, Ben-Ayre et al. in view of Rajangam et al. renders obvious the invention recited in claim 1. Additionally, Rajangam et al. teaches the fibrinogen based microcarrier scaffolds taught are biodegradable. [Pg. 3656, Col. 2, Par. 2]
With respect to Claim 88, Ben-Ayre et al. in view of Rajangam et al. renders obvious the invention recited in claim 1. Additionally, Rajangam et al. teaches that some common biomimetic scaffolds can comprise gelatin, collagen, fibrinogen and fibrin, [Pg. 3641, Par. 2] and that the fibrinogen can be derived from bovine. [Pg. 3650, Col. 2, Par. 2] It is well-known in the field of endeavor that fibrinogen and thrombin are proteins that exist in blood plasma.
According to MPEP 2131.02 I, “A generic claim cannot be allowed to an applicant if the prior art discloses a species falling within the claimed genus”. With respect to the limitation of “the microcarriers comprise non-human blood plasma”, the fibrinogen taught by Rajangam et al. would be a species of the larger genus “blood plasma”. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to have used the teaching of Ben-Ayre et al. in view of Rajangam et al. to produce a meat composition according to claim 88, wherein the microcarrier scaffolds comprise non-human blood plasma.
With respect to Claim 89, Ben-Ayre et al. in view of Rajangam et al. renders obvious the invention recited in claim 88. Additionally, Rajangam et al. teaches that fibrinogen is a blood protein. [Pg. 3641, Par. 2] Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have used the teaching of Ben-Ayre et al. in view of Rajangam et al. to have produced the invention recited in claim 89, wherein the blood plasma comprises fibrinogen.
With respect to Claims 90-92, Ben-Ayre et al. in view of Rajangam et al. renders obvious the invention recited in claim 1. Additionally, Ben-Ayre et al. teaches the animal cells may comprise myoblasts, fibroblasts, and progenitor cells, [067] wherein the progenitor cells comprise stem cells. [071] Therefore, Ben-Ayre et al. in view of Rajangam et al. renders claims 90-92 obvious.
With respect to Claims 93, 94, and 96, Ben-Ayre et al. in view of Rajangam et al. renders obvious the invention recited in claim 92. Additionally, Ben-Ayre et al. teaches the progenitor cells may comprise mesenchymal stem cells, embryonic stem cells, [071] as well as adipocyte progenitor cells. [073] The adipocyte progenitor cells read on the limitation of adipose-derived stem cells. Therefore, Ben-Ayre et al. in view of Rajangam et al. renders obvious the claims 93, 94, and 96.
With respect to Claim 95, Ben-Ayre et al. in view of Rajangam et al. renders obvious the invention recited in claim 1. Additionally, Rajangam et al. teaches a composition comprising the fibrin scaffolds with bone marrow cells and mesenchymal stem cells, which propagate into bone cells. [Pg. 3654, Col. 1, Par. 2] The cells grown from the mixture of bone marrow cells and mesenchymal stem cells read on bone marrow derived stem cells.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to have used the teaching of Ben-Ayre et al. in view of Rajangam et al. in order to produce a cultured meat product comprising animal cells, wherein the animal cells are bone marrow derived stem cells, thereby rendering claim 95 obvious.
With respect to Claim 105, Ben-Ayre et al. in view of Rajangam et al. renders obvious the invention recited in claim 1. The recitation of “the microcarrier scaffolds are produced by a process comprising suspending dissolved protein in an acid solution, and coagulating the dissolved protein in a solution” amounts to a product by process limitation. According to MPEP 2113, “even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself.” The microcarrier scaffolds taught by Ben-Ayre et al. in view of Rajangam et al. render obvious the microcarrier scaffolds in claim 1.
Additionally, Rajangam et al. teaches a method of developing fibrinogen-based scaffolds designed by Sell et al. that comprises a fibrinogen and a 1-ethyl-3-(3-dimethylaminopropyl) carbodiimide hydrochloride solution, wherein the EDC causes cross-linking in the fibrinogen, resulting in a microcarrier scaffold. [Pg. 3650, Col. 2, Par. 2] As EDC is acidic, this method reads on the limitation of suspending a protein in an acid solution, and coagulating the dissolved protein.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to have used the teaching of Ben-Ayre et al. in view of Rajangam et al. to produce a microcarrier scaffold produced by the process of dissolving protein in an acid solution and coagulating the dissolved protein in a solution, thereby rendering claim 105 obvious.
With respect to Claim 106, Ben-Ayre et al. in view of Rajangam et al. renders obvious the invention recited in claim 1. Additionally, Ben-Ayre et al. teaches that the invention taught is directed to a composition suitable for cell growth comprising a cell culture medium [066] and that the culturing of cells is performed in the presence of a cell culture medium. [092] Rajangam et al. teaches a blood plasma protein in fibrinogen for use in microcarrier scaffolds. [Pg. 3641, Par. 2]
For the purposes of examination, the recitation of “blood plasma protein arise from a cell culture” will be interpreted as reciting the limitation that any amount of the protein is grown ex-vivo. The hydrogel scaffolds taught by Rajangam et al. are not grown in-vivo, but in a thrombin solution in the presence of Ca2+. [3646, Col. 2, Par. 2] Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to have used the cell culture taught by Ben-Ayre et al. in order to produce the fibrinogen taught by Rajangam et al., thereby rendering claim 106 obvious.
With respect to Claim 107, Ben-Ayre et al. in view of Rajangam et al. renders obvious the invention recited in claim 1. Additionally, Ben-Ayre et al. teaches that the microcarrier scaffolds are porous. [069]
With respect to Claim 108, Ben-Ayre et al. in view of Rajangam et al. renders obvious the invention recited in claim 1. Additionally, Ben-Ayre et al. teaches the animal cells can be derived from bovine cells, [076] and Rajangam et al. teaches the fibrinogen can be derived from bovine. [Pg. 3650, Col. 2, Par. 2] Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to have used the teaching of Ben-Ayre et al. in view of Rajangam et al. in order to produce the invention of claim 108, wherein the animal cells and blood plasma protein are derived from the same non-human species, thereby rendering claim 108 obvious.
Conclusion
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/J.C.M./Examiner, Art Unit 1791
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791