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 June 29, 2026 has been entered. Claims 1-11, 13-16, 19-20, 23-27, and 31-33 are pending. No claims have 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 1-11, 13-16, 19-20, 23-27, and 31-33 are rejected under 35 U.S.C. 103 as being unpatentable over Enrione et al. (“Edible Scaffolds Based on Non-Mammalian Biopolymers for Myoblast Growth”, Materials MDPI, Published 8 December 2017; made of record by applicant) in view of Oei (EP 2835058 A1; made of record by applicant) and Dehghani et al. (“Engineering porous scaffolds using gas-based techniques”, Current Opinion in Biotechnology, 2011, 22:661-666; Retrieved from Internet URL: https://annabilab.ucla.edu/wp-content/uplaods/2025/01/J12-Engineering-porous-scaffolds-using-gas-based-technologies.pdf).
Regarding claim 1, Enrione discloses a method of making a meat-based food product comprising providing a 3D edible scaffold comprising an edible matrix having pores, or voids. Enrione teaches that the 3D edible scaffold comprising a porous structure allows for better cell adhesion and growth, which high cell proliferation, viability and adequate cell distribution throughout (Abstract). Enrione teaches that the 3D edible scaffold is obtained by providing a continuous edible matrix, which is then converted into the 3D scaffold by introducing voids via foaming (e.g. adjusting the volume; and lyophilization or freeze-drying) (Section 2.4 Scaffold Preparation). Enrione teaches that the edible matrix comprises micro- or macronutrients required for growth (Sections 1 and 2).
Enrione further teaches adhering the 3D edible scaffold with a myoblast culture to generate an inoculated scaffold, and growing the inoculated scaffold at growth conditions that allow for growth of the myoblast culture so that it grows through the scaffold to form an in-vitro meat-based food product (Sections 1-2).
Enrione teaches the process as described above, wherein myoblasts are grown on a 3D edible scaffold to form in-vitro meat product, but fails to teach using fungus instead of myoblast, wherein the 3D edible scaffold is inoculated with at least one fungus and incubated to allow for mycelium grown to form a fungus-based food product.
Oei discloses a meat substitute composition and method thereof, wherein an edible substrate is inoculated with at least one fungus and incubated to allow the mycelium to grow for a period sufficient to provide a meat substitute product ([0010]).
As Oei teaches that it is known in the art to use a similar method as Enrione, adhering fungus instead of myoblast to a substate, or scaffold, it would have been obvious to one of ordinary skill in the art to use fungus in the method of Enrione, such that the 3D edible scaffold of Enrione is inoculated with at least one fungus. Doing so would allow the method of Enrione to provide a meat substitute product and would have been obvious to one of ordinary skill in the art if a meat substitute product was desired. This is merely a substitute of adhering one known culture for another onto a substrate and would have been obvious in order to product a fungus based, or meat substitute, food product.
As stated above, Enrione teaches that the 3D edible scaffold is obtained by providing a continuous edible matrix, which is then converted into the 3D scaffold by introducing voids via foaming (e.g. adjusting the volume; and lyophilization or freeze-drying) (Section 2.4 Scaffold Preparation), but fails to specifically teach that the foaming comprises dispersing gas or dissolving gas under pressure followed by bubble nucleation.
Dehghani teaches different methods for engineering porous, or 3D, scaffolds, wherein one of the methods can include gas-based techniques, such as gas foaming. Dehghani teaches that gas foaming utilized the nucleation and grown of gas bubbles dispersed through a continuous matrix to product porous scaffolds (pg 661).
As such method of foaming comprising dispersing gas or dissolving gas under pressure followed by bubble nucleation is well known in the art for producing 3D scaffolds as taught by Dehghani, it would have been obvious to use such foaming method in the Enrione for producing the 3D edible scaffold of Enrione. Dehghani teaches that gas foaming has advantages over freeze-drying, such that it provides better control over porosity, the shape of the pores, and pore interconnectivity (pg 661), and therefore would further have been obvious to use the gas foaming technique of Dehghani in the method of Enrione.
Regarding claim 2, Enrione discloses a 3D scaffold comprising a multitude of voids that are partly interconnected so as to allow growth into the scaffold and through it (See Fig. 3).
Regarding claim 3, Enrione discloses that the voids can be bound by at least a concave surface of the scaffold (See Fig. 3).
Regarding claim 4, Enrione teaches that the 3D porous structure, or scaffold, allows for better cell adhesion and cell growth (Section 2.7).
It would have been obvious to one of ordinary skill in the art to have the fungal mycelium contained in at least 10% of the voids in the scaffold at the end of the incubation step. Enrione teaches the benefits of having a 3D porous scaffold as it allows for better cell growth and therefore it would have been obvious to one of ordinary skill in the art to incubation for a sufficient amount of time to allow the mycelium to grow and occupy at least 10% of the voids in order to generate a food product having a desired tissue structure or desired texture.
Regarding claim 5, Enrione teaches that the 3D scaffold is configured to create a food product having fiber-like meat texture as it produces tissue for meat consumption to mimic animal-derived meat products (Section 1: Introduction).
Regarding claim 6, as stated above, Enrione teaches a scaffold comprising voids. Enrione further teaches that the average size of the voids is about 200 um (Abstract), thus falling within the claimed range of between 20 um to 4 cm.
Regarding claim 7, Enrione does not teach the use of extrusion to create macrostructures or filaments.
Regarding claim 8, Enrione further teaches that that edible scaffold is not formed by assembling filaments.
Regarding claim 9, as stated above, Enrione teaches the 3D edible scaffold formed by the process of claim 1. Enrione further teaches that voids are introduced into the edible matrix, the edible matrix is introduced into a mold (e.g. petri dish), and the edible matrix is solidified in the mold, wherein the edible matrix is introduced into the mold before being formed into a macrostructure (Section 2.4 Scaffold Preparation).
With respect to the exact order of processing steps, it would have been obvious to foam the edible matrix first before pouring into a mold if desired as it would not result in a difference in the method and final product. This is merely an obvious variant over the prior art (See MPEP 2144.04).
Regarding claim 10, Enrione does not teach the use of extrusion to create macrostructures or filaments before being introduced into the mold.
Regarding claim 11, Enrione further teaches that the distribution of voids, or pores, in the scaffold is fixed upon solidification (Section 2.4 Scaffold Preparation).
Regarding claim 13, Enrione teaches that the voids are introduced into the matrix by foaming (e.g. adjusting the volume; and lyophilization or freeze-drying) and the foam is solidified by gelation (Section 2.4 Scaffold Preparation).
Regarding claim 14, Enrione teaches that the edible matrix is volume adjusted, or foamed, in the petri dish, or mold, which is then cooled down to induce gelation (Section 2.4 Scaffold Preparation).
With respect to the exact order of processing steps, it would have been obvious to foam the edible matrix first before pouring into a mold if desired as it would not result in a difference in the method and final product. This is merely an obvious variant over the prior art (See MPEP 2144.04).
Regarding claim 15, it would have been obvious to carry out steps a and b in a single step if desired as it would not have resulted in a different product.
Regarding claim 16, Enrione further teaches the edible scaffold comprising more than 0.1% by weight protein from salmon gelatin (Section 1. Introduction and Table 1)
Regarding claim 19, as stated above, Enrione teaches that the edible matrix comprises a gel-forming polysaccharide or protein, wherein the gel is formed upon cooking as the edible matrix is cooled down to induce gelation (Section 1. Introduction and Table 1, Section 2.4 Scaffold Preparation).
Regarding claim 20, Enrione teaches that the edible scaffold contains at least a percentage of components which cannot be consumed by the fungus as Enrione teaches that the scaffold structure is maintained during the growth period (Section 2.4 Scaffold Preparation).
Regarding claim 23, Enrione teaches that the growth of the at least one culture is stopped by changing the water activity (e.g. the scaffold is removed from the growth media, Section 2.7 in Enrione, , and therefore the water activity is changed after removal from the growth media).
Regarding claims 24-25, Oei further teaches exposing the meat substitute food product to a liquid so that the food product absorbs the liquid, wherein the liquid can be lipids or fat ([0039]-[0040]).
Regarding claim 26, Oei teaches that the fungus-based food product is cut to a desired size and shape to mimic animal-derived meat products (See Examples).
Regarding claim 27, the prior art as described above with respect to claim 1 renders obvious a fungus-based food product obtainable by the method of claim 1.
Regarding claim 31, as stated above, Enrione teaches that the voids have a size of about 200 um. The prior art, however, fails to teach the diameter not being larger than double the growth height of the fungus in the free space.
It would have been obvious to one of ordinary skill in the art to vary the diameter of the voids by varying the processing conditions of making the voids in order to result in a desired size. Ensuring the diameter is an appropriate size allows for a desired formation of tissue mimicking a desired food product.
Regarding claim 32, Enrione teaches that step a2 comprises pouring into a mold (e.g. petri dish) (Section 2.4 Scaffold Preparation).
Regarding claim 33, Enrione teaches that step a3 comprises solidifying by gelation (Section 2.4 Scaffold Preparation).
Response to Arguments
Applicant’s arguments with respect to the 103 over Enrione in view of Oei and Dehghani have been fully considered but were not found persuasive.
Applicant argues on pages 6-8 that the “substitution of adhering one known culture for another onto a substrate” is not obvious in the prior art as Enrione grows muscle cells by adhering to the surfaces of the scaffold, wherein the design rational is directed to cell adhesion. Applicant further states that Oei instead grows by connecting the substrate and does not adhere to a surface by grows among the loose substrate ingredients.
This is not found persuasive as Oei is being relied upon to show that growing mycelium on an edible substrate is well known in the art as it produces a meat substitute product. The examiner notes that it would be expected that growing mycelium on the substrate of Enrione would predictably provide cell adhesion. The method of adhering and growing would be depending on the type of substrate or scaffold used.
As Oei teaches that it is known in the art to use a similar method as Enrione, growing fungus instead of myoblast on a substate, or scaffold, to produce a meat type product, it would have been obvious to one of ordinary skill in the art to use fungus in the method of Enrione, such that the 3D edible scaffold of Enrione is inoculated with at least one fungus. Doing so would allow the method of Enrione to provide a meat substitute product and would have been obvious to one of ordinary skill in the art if a meat substitute product was desired.
Again, as Oei suggests the use of mycelium, the combination of Enrione and Oei renders obvious to claimed method, wherein the 3D edible scaffold of Enrione is inoculated with at least one fungus to grown mycelium to form a fungus-based food product. Again, the way the mycelium grows would be dependent on the type of substrate, or scaffold, used. Further, the claims do not require any specific growth pattern. Therefore, the combination of Enrione and Oei suggests adhering fungus to the 3D edible scaffold and allowing the mycelium to grow through cell adhesion as taught by Enrione.
Applicant further argues on pages 8-10 that Enrione does not teach forming the 3D scaffold by foaming or puncturing as claimed. The examiner agrees that Enrione fails to teach foaming by dispersing gas or dissolving gas under pressure as claimed. However, the examiner relies upon the teachings of Dehghani to show that forming 3D scaffolds by dispersing gas or dissolving gas under pressure is well known in the art.
As stated above, Enrione teaches that the 3D edible scaffold is obtained by providing a continuous edible matrix, which is then converted into the 3D scaffold by introducing voids (e.g. adjusting the volume; and lyophilization or freeze-drying) (Section 2.4 Scaffold Preparation), but fails to specifically teach that the voids are introduced by dispersing gas or dissolving gas under pressure followed by bubble nucleation.
Dehghani teaches different methods for engineering porous, or 3D, scaffolds, wherein one of the methods can include gas-based techniques, such as gas foaming. Dehghani teaches that gas foaming utilized the nucleation and grown of gas bubbles dispersed through a continuous matrix to product porous scaffolds (pg 661).
As such method of foaming comprising dispersing gas or dissolving gas under pressure followed by bubble nucleation is well known in the art for producing 3D scaffolds as taught by Dehghani, it would have been obvious to use such foaming method in the Enrione for producing the 3D edible scaffold of Enrione. Dehghani teaches that gas foaming has advantages over freeze-drying, such that it provides better control over porosity, the shape of the pores, and pore interconnectivity (pg 661), and therefore would further have been obvious to use the gas foaming technique of Dehghani in the method of Enrione.
Therefore, the teachings of Dehghani suggest a different method for forming a 3D scaffold than what is taught by Enrione. Using a different known 3D scaffold process would have been obvious as Dehghani teaches that gas foaming has advantages over freeze-drying, such that it provides better control over porosity, the shape of the pores, and pore interconnectivity (pg 661), and therefore would further have been obvious to use the gas foaming technique of Dehghani in the method of Enrione.
The combination of Enrione and Dehghani still uses a 3D scaffold, merely suggests a different process for forming the scaffold, which would not change the final outcome in Enrione and is therefore obvious to one of ordinary skill in the art.
In response to both applicant's arguments above, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
In the instant case the combined teachings suggest growing mycelium on a 3D edible scaffold to produce a meat substitute product, wherein the 3D scaffold is preparing by dispersing gas or dissolving gas under pressure followed by bubble nucleation.
For the reasons stated above, a 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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