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 .
This office action is in regard to the application filed on December 23, 2021 and in response to a Request for Continued Examination filed on December 3, 2025.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on December 3, 2025 has been entered.
Status of Application
The amendment filed December 3, 2025 has been entered. Claims 19, 21, 23, and 25-32 are currently pending in the application. Claims 1-18, 20, 22, and 24 are canceled. Claims 19, 23, and 27 have been amended. Claims 19, 21, 23, and 25-32 are hereby examined on the merits.
The previous claim objection to claim 27 has been withdrawn in view of applicant’s claim amendments.
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.
Claims 19, 21, 23, and 25-32 are rejected under 35 U.S.C. 103 as being unpatentable over Bilet et al. (US PG Pub 2014/0147555; cited on PTO-892 dated Feb, 29, 2024) in view of Corral et al. (“Antimicrobial Activity of Sodium Bicarbonate”, Journal of Food Science, Vol. 53, No. 3, pp. 981-982; 1988; cited on PTO-892 dated Feb, 29, 2024), Enrione et al. (“Edible Scaffolds Based on Non-Mammalian Biopolymers for Myoblast Growth.” Materials, 10, 1404. 2017; cited on PTO-892 dated Feb, 29, 2024), and Rowat et al. (WO 2020/219755; cited on PTO-892 dated Feb. 25, 2025), herein after referred to as Bilet, Corral, Enrione, and Rowat, respectively.
Regarding claims 19 and 26, Bilet teaches a method of forming a porous scaffold that is a framework for depositing cells (i.e., a porous scaffold) [0085], the method comprising:
combining soy protein isolate (i.e., plant-derived protein isolate [0039]), other ingredients (i.e., agar (a porogen) [0078] and glycerol (an emulsifier) [0052]), and water (i.e., a solvent) to prepare a mixture (i.e., stirring the mixture to produce a stirred mixture) [0093];
molding the mixture through an extruder [0093];
coating the mixture with a flavored coating (i.e., an antimicrobial agent) to produce a coated mixture ([0094]; [0058-0059]); and
drying the coated mixture [0095].
Bilet is silent as to after coating the mixture, allowing the coated mixture to sit at room temperature for 4 hours for absorption. However, Bilet does teach that after the strands are coated, the mixture can be “dried, fried, frozen, sterilized, heated, or otherwise treated” [0095]. Thus, where it was known in the art to treat a coated mixture, it would have been obvious to have let the coated mixture sit in order for the coating to penetrate the mixture. Absent any evidence or showing of criticality for the claimed room temperature and time limit, the parameters taught by Bilet are considered to render obvious the claimed limitation.
Bilet does not teach that the mixture is coated with sodium bicarbonate. Bilet does teach that the mixture (i.e., the dietary strands) are coated with an antimicrobial agent [0058-0059].
Corral, in the same field of invention, teaches that sodium bicarbonate prevents the growth of various bacteria associated with food safety and is thus an effective antimicrobial agent (Results & Discussion). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have used sodium bicarbonate of Corral as the antimicrobial agent of Bilet, thereby arriving at the claimed invention, with the reasonable expectation that sodium bicarbonate is a suitable antimicrobial agent and coating.
Bilet does not teach freeze-drying the stirred mixture after molding the mixture to produce a freeze-dried mixture, wherein freeze-drying comprises:
freezing the molded mixture to produce a frozen mixture; and
adding a coagulant to the freeze-dried mixture to form the porous muscle cell scaffold.
Enrione, in the same field of invention, teaches preparing a scaffold through freeze-drying, wherein after the solution (i.e., mixture) is poured and molded into a petri dish, the solution is frozen to produce a frozen mixture and then undergoes lyophilization (i.e., freeze drying), after which calcium chloride (i.e., a coagulant) is added to the freeze-dried mixture to form a porous scaffold (2.4. Scaffold Preparation). Enrione offers the motivation that freeze-drying is a conventional method to produce three-dimensional porous scaffolds (2.1. Experimental Strategy) and that freeze-drying sublimes out ice formed during freezing (2.4. Scaffold Preparation). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the scaffold production method of Bilet by incorporating the freeze-drying steps of Enrione after the molding step of Bilet, thereby arriving at the claimed invention, with the reasonable expectation that freeze-drying the mixture will result in a suitable three-dimensional porous scaffold.
Bilet, Corral, and Enrione do not teach that the coagulant is glucono-delta-lactone and that the porous scaffold is utilized for mass-production of in-vitro meat.
Rowat, in the same field of invention, teaches myocytes (muscle cells) cultured on a porous scaffold with increased production efficiency and upscaled cell culture (i.e., mass-production of in-vitro meat) [0044], wherein the scaffold comprises glucono-delta-lactone (GDL) as a coagulant. Rowat offers the motivation that the scaffold can be produced in a single-batch bioreactor system [0044] and that the GDL crosslinks the nanofibers to form an interconnected scaffold [0093]. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have used the GDL of Rowat as the coagulant of Bilet, Corral, and Enrione. One would have been motivated to make this modification for the benefit of forming an interconnected scaffold.
The method taught by Bilet in view of Corral, Enrione, and Rowat, herein after referred to as modified Bilet, differ from the instant claim in that the process steps are completed in a different order. However, selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results. In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930). As well as that the selection of any order of mixing ingredients is prima facie obvious. Thus, the method of modified Bilet renders obvious the instant claim.
Modified Bilet is silent as to that the porous scaffold has all of properties of:
compressive strength in a range of 80 kPa to 150 kPa;
tensile strength in a range of 40 gf to 70 gf;
yield strength in a range of 18 kPa to 32 kPa;
yield elongation in a range of 10% to 20%;
open porosity in a range of 50% to 80%, wherein the open porosity is a ratio of the volume of pores exposed to a space surrounding the scaffold to the total volume of the porous muscle cell scaffold;
total porosity in a range of 40% to 80%; and
pore interconnectivity in a range of 95% to 99.9%.
Modified Bilet is also silent as to that the porous scaffold has a pore size in a range of 50 μm to 400 μm.
However, per MPEP 2112.01 (I), where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
The properties of the claimed product are expected to be the same as the properties of the composition of the prior art because the products contain the same components and are produced by substantially identical processes. The porous scaffold of modified Bilet contains a plant-based protein isolate, a porogen, an emulsifier, a solvent, a coagulant, and sodium bicarbonate, which are the same components of the porous muscle cell scaffold of the instant claim. The method steps of producing the scaffold of modified Bilet are also substantially similar to that of the instant claim. Further, the present disclosure does not provide any evidence that the specific components or method used in the invention yield different properties in the final product than what is well known and expected in the art. The porous scaffolds of the prior art and the instant claim are produced by substantially identical processes, and thus, the scaffolds are expected to possess the same properties of compressive strength, tensile strength, yield strength, yield elongation, open porosity, total porosity, and pore interconnectivity.
Regarding claims 21 and 23, modified Bilet is silent as to that the porous scaffold has the following properties of:
hardness in a range of 0.4 kgf to 1.0 kgf;
springiness in a range of 0.8 to 1.2;
open porosity in a range of 55% to 60%, and
total porosity in a range of 55% to 60%.
However, per MPEP 2112.01 (I), where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
The properties of the claimed product are expected to be the same as the properties of the composition of the prior art because the products contain the same components and are produced by substantially identical processes. The porous scaffold of modified Bilet contains a plant-based protein isolate, a porogen, an emulsifier, a solvent, a coagulant, and sodium bicarbonate, which are the same components of the porous scaffold of the instant claim. The method steps of producing the scaffold of modified Bilet are also substantially similar to that of the instant claim. Further, the present disclosure does not provide any evidence that the specific components or method used in the invention yield different properties in the final product than what is well known and expected in the art. The porous scaffolds of the prior art and the instant claim are produced by substantially identical processes, and thus, the scaffolds are expected to possess the same properties of hardness, springiness, open porosity, total porosity, pore interconnectivity, and pore size.
Regarding claim 25, modified Bilet teaches that the plant-derived protein isolate is a protein isolated from soybeans (Bilet: [0038]-[0039]).
Regarding claims 27 and 28, modified Bilet teaches a porous scaffold produced by the method of claim 19 and that meat cells are deposited (i.e., dispensed) and induced (i.e., cultured) into the scaffold (Bilet: [0085]) wherein the meat cells are myocytes (muscle cells) (Rowat: [0012]).
Regarding claim 29, modified Bilet teaches that the production of the porous scaffold is produced in a single-batch bioreactor system which increases production efficiency and scaled-up cell culture (i.e., the porous scaffold is for the mass-production of in-vitro meat) (Rowat: [0044]).
Regarding claim 30, modified Bilet teaches synthetic meat (i.e., in-vitro meat) that comprises the porous scaffold of claim 27 and a cell deposited into the scaffold (Bilet: [0085]).
Regarding claim 31, modified Bilet teaches a three-dimensional muscle cell aggregate for producing in-vitro meat, as the cells are attached and induced (Bilet: [0085]) on a three-dimensional scaffold (Bilet: [0026]), wherein the cells are myocytes (muscle cells) (Rowat: [0012]). Modified Bilet does not specify whether the cells are cultured before or after they are deposited on the scaffold. However, the present invention does not disclose that the steps completed in this order yield new or unexpected results; In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946), the selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results. Therefore, one of ordinary skill in the art would have expected that any order of steps would continue to provide an in-vitro meat product.
Regarding claim 32, modified Bilet teaches an edible composition that comprises the synthetic meat of claim 30 (Bilet: [0085]).
Response to Arguments
Applicant's arguments filed December 3, 2025 have been fully considered but they are not persuasive.
The prior art rejection has been amended in light of applicant’s amendments to the claims, however, the essential prior art rejection has been maintained by the examiner for the following reasons.
Applicant argues that the prior art fails to teach the claimed method and that the claimed method is different from the teachings of the prior art. Specifically, applicant argues that the claimed method steps of freezing, applying sodium bicarbonate, then applying a coagulant are critical in their order because the specific order is essential for controlling the porosity and physical properties of the cell scaffold. Applicant further argues that the order of steps are critical to the formation of a uniform and regular porous structure in the scaffold. Applicant cites an additional reference, Annabi et al., to support these arguments of criticality (remarks, p. 5-9).
This argument is not persuasive. As stated previously and as above in the rejection, the selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results. In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930). Thus, while applicant argues that the claimed method steps are critical because they offer advantageous results not suggested by the prior art, these results are not new or unexpected. These results are not considered to be new or unexpected due to applicant’s own citation of an additional reference, Annabi et al., that contemplates these advantageous results for the specific claimed method steps. Therefore, it would have been obvious to one of ordinary skill in the art, to have performed the method steps taught by the prior art in any order that would result in known desired results. Additionally, where Enrione teaches freeze-drying after molding, it would have been obvious to have incorporated the freeze-drying step after the molding step of Bilet and before the coating step of Bilet.
Moreover, applicant has not shown any evidence that the scaffold and method of the prior art would not also possess these alleged advantages, a showing of which would help successfully rebut the rejection’s rationale.
Applicant argues that the sodium bicarbonate coating of the claimed scaffold has a different purpose than the purpose in the claimed method (remarks, p. 8-9).
This argument is not persuasive. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006). See MPEP 2144.IV. The prior art does not need to suggest that the sodium bicarbonate coating achieves uniform pores and structural integrity as the prior art has its own motivation to combine the references.
Applicant argues that the scaffold of the claimed method has specific properties, such as compressive strength, tensile strength, various other strengths, and various porosity values, that are not present in the scaffold of the prior art. Applicant additionally argues that the scaffold of the claimed invention has significant effects in cell adhesion and proliferation, enables the mass-production of cultured meat, and enables the production of high-quality cultured meat in a short period of time (remarks, p. 10-12).
This argument is not persuasive. Applicant has not provided any evidence or showing that these properties or functions would not also exist in the scaffold of the prior art, which is necessary in overcoming the rejection since compositions that are substantially the same and/or are produced by the substantially same method, are considered to necessarily possess the same characteristics and properties.
In the absence of any further arguments with regard to the rejections of the additional dependent claims, the rejections of these claims are maintained.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAURA E SWEENEY whose telephone number is (571)272-0244. The examiner can normally be reached M-F 8:00-5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nikki Dees can be reached at (571)-270-3435. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.E.S./Examiner, Art Unit 1791
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791