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 .
The Amendment filed Feb. 9, 2026 has been entered. Claims 1-24 are pending. Claim 18 has been amended.
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 1-24 are rejected under 35 U.S.C. 103 as being unpatentable over Vein (US 2005/00190965) in view of Lelkes (US 2012/0058090).
Regarding claims 1 and 7, Vein discloses a non-human tissue engineered meat product and a method for producing such meat product. Vein teaches that the meat product comprises muscle cells and is used for food consumption. (Abstract)
Vein discloses that a population of muscle cells are grown in culture into muscle tissues that are attached to a support structure such as two or three-dimensional scaffold or support structure. [0012]
Vein discloses the use of two- or three-dimensional scaffolds (supports) for growing animal cells into muscle tissue as described above, and further teaches using electric or oscillating current to increase similarity in texture between the cultered meat and meat derived from whole animals, but fails to specifically teach that the scaffold comprises electrospun polymer fibers.
Lelkes discloses alimentary protein-based scaffolds. The scaffolds are produced from plant products. The engineered biomaterials are able to support the growth of animal cells. (Abstract) Lelkes further discloses that plant material is electrospun to produce electrospun fibers. [0013-0014] Lelkes teaches of using various natural and/or synthetic polymers for producing the scaffolds. [001-0012, 0018-0019]
As Lelkes teaches that it is well known in the art to grown muscle cells on a scaffold comprising electrospun polymer fibers, it would have been obvious to have the scaffold of Vein comprise electrospun polymer fibers. Lelkes teaches that this type of scaffold has the advantage of providing a unique mix of mechanical and physical properties that facilitate cell penetration and proliferation within the scaffolds ([0034]-[0035]) and therefore would expectedly provide the same advantages to the scaffold of Vein.
With respect to the cultered meat product having a thickness as claimed, Vein teaches that the scaffold may be sculpted into different sizes, shapes, and forms, as desired to provide the shape of form to resemble the meat product being made ([0013]). It is well known in the art that meat products vary is size and thickness.
It would have been obvious to one of ordinary skill in the art to vary the size and shape of the scaffold of Vein to result in a cultured meat product having a desired thickness. The prior art clearly teaches that the scaffold size/length can vary depending on the desired meat product being mimicked and therefore it is well within the ordinary skill to vary the thickness.
Further, as stated in MPEP 2144.04, a change in size is merely an obvious variant over the prior art.
Regarding claim 2, Vein teaches that the support structure, or scaffold, can be made from natural or synthetic biomaterials, including collagen, alginate and copolymers thereof ([0015]).
Lelkes teaches that the electrospun polymer fibers can also be made from collagen and alginate, and further fibrin, fibronectin, a plant protein, along with a variety of synthetic materials ([0110]-[0115]).
Regarding claims 3-5, as stated above, Vein in view of Lelkes teaches the use of electrospun polymer fibers for the scaffold, and both references further teach the use of the same materials for the scaffold as claimed.
Vein teaches that the support structure, or scaffold, can be made from natural or synthetic biomaterials, including collagen, alginate and copolymers thereof ([0015]).
Lelkes teaches that the electrospun polymer fibers can also be made from collagen and alginate, and further fibrin, fibronectin, a plant protein, along with a variety of synthetic materials ([0110]-[0115]).
Therefore, the polymers taught by the prior are would be “configured” to degrade to produce a byproduct as claimed or degrade upon exposure to saliva as claimed as the polymer of the prior art and that of the instant invention are the exact same.
As stated in In re Best, 562 F.2d 1252, 1255 (CCPA 1977): Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on "inherency" under 35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products.
Regarding claim 6, Lelkes further teaches that the scaffold comprises multiple electrospun polymer fibers aligned in a desired direction ([0148]). Lelkes teaches that the alignment is dependent on the desired application and can be vary between a single direction, criss-cross alignment in orthogonal directions, or more complicated fiber architecture in order to more closely match the product/application it is being used for.
As Vein teaches that the scaffold may be sculpted into different sizes, shapes, and forms, as desired to provide the shape of form to resemble the meat product being made ([0013]), it would have been obvious to one of ordinary skill in the art, based upon the teachings of both Vein and Lelkes, to align the electrospun polymer fibers substantially parallel to one another is desired.
Regarding claims 8-9, Vein teaches that the cultured meat product is configured to mimic a property of a traditional slaughtered meat, such as shape, size, and texture ([0013], [0019]).
Regarding claim 10, Vein teaches that the muscle cells are derived from embryonic mesenchymal stem cells that give rise to muscle cells. The muscle cells may also be derived from other tissues. [0011]
Regarding claim 11, Vein teaches that the scaffold may be sculpted into different sizes, shapes, and forms, as desired to provide the shape of form to resemble the meat product being made ([0013]).
Lelkes further teaches that the scaffold may be shaped into different sizes depending on the application ([0121]).
Both, however, fail to teach a plurality of electropsun fiber fragments having a maximum length of about 10 mm.
However, it would have been obvious to one of ordinary skill in the art to vary the length of the fiber fragments depending on the desired shape and size of the scaffold. The prior art clearly teaches that the scaffold size/length can vary depending on the desired use and therefore it is well within the ordinary skill to vary the length of each fragment in order to obtain a scaffold of desired size.
Further, as stated in MPEP 2144.04, a change in size is merely an obvious variant over the prior art.
Regarding claims 12 and 20, Vein discloses a method of producing a cultured meat product comprising preparing a scaffold comprising polymer fibers, placing the scaffold into a bioreactor, adding a population of cells to the bioreactor, culturing the populating of cells in the bioreactor for a period of time to form a cultured meat product, and removing the cultured meat product from the bioreactor ([0013]-[0019], See Examples).
Vein discloses the use of two- or three-dimensional scaffolds (supports) for growing animal cells into muscle tissue as described above, and further teaches using electric or oscillating current to increase similarity in texture between the cultered meat and meat derived from whole animals, but fails to specifically teach that the scaffold comprises electrospun polymer fibers.
Lelkes discloses alimentary protein-based scaffolds. The scaffolds are produced from plant products. The engineered biomaterials are able to support the growth of animal cells. (Abstract) Lelkes further discloses that plant material is electrospun to produce electrospun fibers. [0013-0014] Lelkes teaches of using various natural and/or synthetic polymers for producing the scaffolds. [001-0012, 0018-0019]
As Lelkes teaches that it is well known in the art to grown muscle cells on a scaffold comprising electrospun polymer fibers, it would have been obvious to have the scaffold of Vein comprise electrospun polymer fibers. Lelkes teaches that this type of scaffold has the advantage of providing a unique mix of mechanical and physical properties that facilitate cell penetration and proliferation within the scaffolds ([0034]-[0035]) and therefore would expectedly provide the same advantages to the scaffold of Vein.
With respect to the cultured meat product having a thickness as claimed, Vein teaches that the scaffold may be sculpted into different sizes, shapes, and forms, as desired to provide the shape of form to resemble the meat product being made ([0013]). It is well known in the art that meat products vary is size and thickness.
It would have been obvious to one of ordinary skill in the art to vary the size and shape of the scaffold of Vein to result in a cultured meat product having a desired thickness. The prior art clearly teaches that the scaffold size/length can vary depending on the desired meat product being mimicked and therefore it is well within the ordinary skill to vary the thickness.
Further, as stated in MPEP 2144.04, a change in size is merely an obvious variant over the prior art.
Regarding claims 13-14, Vein discloses the method as described above, wherein the cells are cultured in the bioreactor for a period of time to form the cultured meat product, but fails to specifically disclose the claimed period of time.
However, it would have been obvious to one of ordinary skill in the art to determine the optimum period of time depending on the type of meat product being meat and the rate of growth on the scaffold. This is merely routine experimentation that is well within the ordinary skill in the art.
Regarding claim 15, Vein teaches that the support structure, or scaffold, can be made from natural or synthetic biomaterials, including collagen, alginate and copolymers thereof ([0015]).
Lelkes teaches that the electrospun polymer fibers can also be made from collagen and alginate, and further fibrin, fibronectin, a plant protein, along with a variety of synthetic materials ([0110]-[0115]).
Regarding claims 16-18, as stated above, Vein in view of Lelkes teaches the use of electrospun polymer fibers for the scaffold, and both references further teach the use of the same materials for the scaffold as claimed.
Vein teaches that the support structure, or scaffold, can be made from natural or synthetic biomaterials, including collagen, alginate and copolymers thereof ([0015]).
Lelkes teaches that the electrospun polymer fibers can also be made from collagen and alginate, and further fibrin, fibronectin, a plant protein, along with a variety of synthetic materials ([0110]-[0115]).
Therefore, the polymers taught by the prior are would be “configured” to degrade to produce a byproduct as claimed or degrade upon exposure to saliva as claimed as the polymer of the prior art and that of the instant invention are the exact same. Further, as Vein teaches that the product is a meat product, which is intended to be eaten, it would have bene obvious for the method to further comprise exposing the fiber to saliva.
As stated in In re Best, 562 F.2d 1252, 1255 (CCPA 1977): Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on "inherency" under 35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products.
Regarding claim 19, Lelkes further teaches that the scaffold comprises multiple electrospun polymer fibers aligned in a desired direction ([0148]). Lelkes teaches that the alignment is dependent on the desired application and can be vary between a single direction, criss-cross alignment in orthogonal directions, or more complicated fiber architecture in order to more closely match the product/application it is being used for.
As Vein teaches that the scaffold may be sculpted into different sizes, shapes, and forms, as desired to provide the shape of form to resemble the meat product being made ([0013]), it would have been obvious to one of ordinary skill in the art, based upon the teachings of both Vein and Lelkes, to align the electrospun polymer fibers substantially parallel to one another is desired.
Regarding claims 21-22, Vein teaches that the cultured meat product is configured to mimic a property of a traditional slaughtered meat, such as shape, size, and texture ([0013], [0019]).
Regarding claim 23, Vein teaches that the muscle cells are derived from embryonic mesenchymal stem cells that give rise to muscle cells. The muscle cells may also be derived from other tissues. [0011]
Regarding claim 24, Vein teaches that the scaffold may be sculpted into different sizes, shapes, and forms, as desired to provide the shape of form to resemble the meat product being made ([0013]).
Lelkes further teaches that the scaffold may be shaped into different sizes depending on the application ([0121]).
Both, however, fail to teach a plurality of electropsun fiber fragments having a maximum length of about 10 mm.
However, it would have been obvious to one of ordinary skill in the art to vary the length of the fiber fragments depending on the desired shape and size of the scaffold. The prior art clearly teaches that the scaffold size/length can vary depending on the desired use and therefore it is well within the ordinary skill to vary the length of each fragment in order to obtain a scaffold of desired size.
Further, as stated in MPEP 2144.04, a change in size is merely an obvious variant over the prior art.
Response to Arguments
Applicant’s amendment has overcome the 112(b) rejection from the previous Office Action and therefore it has been withdrawn.
Applicant’s arguments with respect to the 103 rejection have been fully considered but were not found persuasive.
Applicant argues on pages 6-8 that Vein and Lelkes address fundamentally different problems in different contexts. Applicant states that Vein is directed towards culturing muscle tissue and does not address oral processing, mastication or interaction with saliva, while Lelkes is directed to electrospun protein-based biomaterials for use as cell scaffolds and is silent to whether the materials are intended to be eaten.
This is not found persuasive. Vein teaches producing meat products for consumption ([0008]-[0011]). While Vein might not specifically teach oral processing, mastication or interaction with saliva, Vein teaches that a human is intended to eat the meat product and therefore Vein is directed towards oral processing, mastication and interaction with saliva.
Lelkes discloses alimentary protein-based scaffolds. The engineered biomaterials are able to support the growth of animal cells. (Abstract) Lelkes further discloses that plant material is electrospun to produce electrospun fibers. [0013-0014] As Lelkes teaches that it is well known in the art to grown muscle cells on a scaffold comprising electrospun polymer fibers, it would have been obvious to have the scaffold of Vein comprise electrospun polymer fibers. Lelkes teaches that this type of scaffold has the advantage of providing a unique mix of mechanical and physical properties that facilitate cell penetration and proliferation within the scaffolds ([0034]-[0035]) and therefore would expectedly provide the same advantages to the scaffold of Vein.
Vein teaches that the support structure, or scaffold, can be made from natural or synthetic biomaterials, including collagen, alginate and copolymers thereof ([0015]). Lelkes teaches that the electrospun polymer fibers can also be made from collagen and alginate, and further fibrin, fibronectin, a plant protein, along with a variety of synthetic materials ([0110]-[0115]).Therefore, the polymers taught by the prior are would be “configured” to degrade to produce a byproduct as claimed or degrade upon exposure to saliva as claimed as the polymer of the prior art and that of the instant invention are the exact same. Further, as Vein teaches that the product is a meat product, which is intended to be eaten, it would have bene obvious for the method to further comprise exposing the fiber to saliva.
As stated in In re Best, 562 F.2d 1252, 1255 (CCPA 1977): Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on "inherency" under 35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products.
Further, the claims do not require any type of oral processing or mastication. As stated above, Vein teaches that the product is intended to be eaten by a human and therefore this argument is not found persuasive.
Applicant further argues on page 8 that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, as stated above, Lelkes teaches advantages of using electrospun fibers in a scaffold. Lelkes teaches that this type of scaffold has the advantage of providing a unique mix of mechanical and physical properties that facilitate cell penetration and proliferation within the scaffolds ([0034]-[0035]) and therefore would expectedly provide the same advantages to the scaffold of Vein.
Applicant’s arguments on page 9 are not found persuasive for the same reasons as previously stated.
Applicant further argues on pages 9-11 with respect to claims 11 and 24 that claimed maximum length is essential to ensure that the scaffold behaves appropriately during chewing and ingestion. Applicant states that limiting the fragment length allows the scaffold to mimic the texture and breakdown characteristics of traditional meat during mastication, which still supporting cell growth during cultivation.
This is not found persuasive as applicant has not shown criticality for the claimed range. The prior art clearly recognizes that the scaffold can vary in shape and size as Vein teaches that the scaffold may be sculpted into different sizes, shapes, and forms, as desired to provide the shape of form to resemble the meat product being made ([0013]).Lelkes further teaches that the scaffold may be shaped into different sizes depending on the application ([0121]).
Therefore, it would have been obvious to one of ordinary skill in the art to vary the length of the fiber fragments depending on the desired shape and size of the scaffold. The prior art clearly teaches that the scaffold size/length can vary depending on the desired use and therefore it is well within the ordinary skill to vary the length of each fragment in order to obtain a scaffold of desired size. Further, as stated in MPEP 2144.04, a change in size is merely an obvious variant over the prior art.
For the reasons stated above, the 103 rejection is maintained.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHANIE A KOHLER whose telephone number is (571)270-1075. The examiner can normally be reached Monday-Friday 8am-5pm.
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/STEPHANIE A KOHLER/Primary Examiner, Art Unit 1791
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