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 .
Response to Amendment
The amendment filed June 8, 2026 has been entered.
Claims 1, 3-4, 6, 15, 18, 21, 25, 27, 32-33, and 35 remain pending and examined in the application. Claims 36-37, 40, 42, and 48-53 remain pending and withdrawn. Claims 54-56 are newly added, and are pending and examined. Claims 2, 5, 7-14, 16-17, 19-20, 22-24, 26, 28-31, 34, 38-39, 41, and 43-47 are canceled.
Applicant’s amendments to the Specification and Claims have overcome each and every objection previously set forth in the Non-Final Office Action mailed March 9, 2026.
Based on Applicant’s amendments and remarks, the previous prior art rejection has been modified to address the claim amendments.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3-4, 15, 18, 21, 27, 32, and 54-56 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US Pub. No. 2020/0283712; hereinafter Wang; already of record) in view of Thon et al. (WO Pub. No. 2020/018950; hereinafter Thon; already of record) and Goral (US Pub. No. 2020/0181553; already of record).
Regarding claim 1, Wang discloses a cultivation system for cell and/or tissue cultivation ([0111], [0130]-[0140], see Figs. 14-16C). The system comprises:
at least one cell culture bioreactor ([0111], [0130]-[0140], see Figs. 14-16C). The bioreactor comprises:
at least one scaffold unit comprising a plurality of scaffolds, wherein each scaffold is separated from its neighboring scaffolds to form spaces therebetween enabling liquid flow, wherein at least part of each scaffold comprises cells and/or tissue ([0111], [0130]-[0140], see Figs. 14-16C at bridge 1740 having grooves and grooves 1720 in the rotor for supporting scaffold screens. See also [0078]-[0079], which states that the fibers of the scaffold are seeded with cells).
at least one pump (0145], see Fig. 11 at pump 1140).
Wang fails to explicitly disclose:
that the bioreactor comprises a first surface comprising an inlet port, a second surface comprising an outlet port, and at least one bioreactor wall, wherein the at least one bioreactor wall is extending from the first surface towards the second surface and is defining the internal chamber, and an inlet manifold fluidly coupled to the inlet port and an outlet manifold fluidly coupled to the outlet port, wherein each manifold comprises openings positioned therealong configured to direct a flow of a liquid;
wherein the manifolds are fluidly coupled to the at least one pump, and wherein the at least one pump is configured to control a flow rate of liquid flowing through the at least one scaffold unit and to circulate the liquid within the system,
wherein the at least one scaffold unit is disposed within the internal chamber of the bioreactor, so that at least one of the openings of each manifold is positioned directly opposing a corresponding space between neighboring scaffolds of the scaffold unit, in order to enable direct liquid flow therethrough, and
wherein the at least one pump controls a liquid level above an upper scaffold of the scaffold unit within the cell culture bioreactor, and wherein the liquid level within the cell culture bioreactor is at least about 0.1 mm above the upper scaffold.
Thon is in the analogous field of bioreactors (Thon [0003]). Thon teaches a bioreactor that comprises a first surface comprising an inlet port, a second surface comprising an outlet port, and at least one bioreactor wall, where the at least one bioreactor wall is extending from the first surface towards the second surface and defines an internal chamber (Thon; [0007], [00101], see Fig. 13A at stacked bioreactor 700). An inlet manifold is fluidly coupled to the inlet port and an outlet manifold is fluidly coupled to the outlet port, where each manifold comprises openings positioned therealong configured to direct a flow of liquid (Thon; [0007], [00101], see Fig. 13A). Thon further teaches manifolds that are fluidly coupled to at least one pump, that the at least one pump is configured to control the flow rate of liquid flowing through at least one scaffold unit and to circulate liquid within a system (Thon; [0007]-[0008], [0128], see Fig. 22). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Wang with the teachings of Thon so that the bioreactor comprises a first surface comprising an inlet port, a second surface comprising an outlet port, and at least one bioreactor wall, wherein the at least one bioreactor wall is extending from the first surface towards the second surface and is defining the internal chamber, and an inlet manifold fluidly coupled to the inlet port and an outlet manifold fluidly coupled to the outlet port, wherein each manifold comprises openings positioned therealong configured to direct a flow of a liquid, as Thon teaches that this configuration can be used to provide a substantially equal flow rate of fluid through the scaffolds (Thon [0007]). Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of modified Wang with the further teachings of Thon so that the manifolds are fluidly coupled to the at least one pump, and the at least one pump is configured to control the flow rate of liquid flowing through the at least one scaffold unit and to circulate the liquid within the system, in order to control the flow rates and pressures within the bioreactor (Thon; [0007]-[0008], [0128], see Fig. 22).
Modified Wang fails to explicitly disclose:
the at least one scaffold unit is disposed within the internal chamber of the bioreactor, so that at least one of the openings of each manifold is positioned directly opposing a corresponding space between neighboring scaffolds of the scaffold unit, in order to enable direct liquid flow therethrough, and
wherein the at least one pump controls a liquid level above an upper scaffold of the scaffold unit within the cell culture bioreactor, and wherein the liquid level within the cell culture bioreactor is at least about 0.1 mm above the upper scaffold.
Goral is in the analogous field of a cell culture vessel (Goral [0002]). Goral teaches a cell culture unit disposed within an internal chamber of a bioreactor, so that at least one of the openings of each manifold is positioned directly opposing a corresponding space between neighboring cell culture subunits of the cell culture unit, in order to enable direct liquid flow therethrough (Goral; [0038], see Fig. 2). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of modified Wang with the teachings of Goral so that the at least one scaffold unit is disposed within the internal chamber of the bioreactor, so that at least one of the openings of each manifold is positioned directly opposing a corresponding space between neighboring scaffolds of the scaffold unit, in order to enable direct liquid flow therethrough. The motivation would have been to ensure that liquid is applied to each scaffold of the scaffold unit without any obstructions.
Further, with regards to the at least one pump controlling a liquid level above an upper scaffold of the scaffold unit within the cell culture bioreactor, and wherein the liquid level within the cell culture bioreactor is at least about 0.1 mm above the upper scaffold, the system of modified Wang is identical to the instantly claimed invention. Therefore, absent persuasive evidence, the system of modified Wang is capable of keeping liquid level within the cell culture bioreactor at least about 0.1 mm above the upper scaffold of the scaffold unit, particularly as Wang teaches parallel flow of culture medium in a bioreactor, where the flow of liquid would be pumped to pass over all scaffolds, i.e. the scaffolds would be immersed in the culture medium (Wang; [0158]-[0170], see Figs. 14-16C). Therefore, the system of Wang would be capable of flowing liquid in this controlled manner, particularly when using the pump that utilizes a controlled flow rate of liquid as in Thon.
Note: The instant Claims contain a large amount of functional language (ex: “configured to direct a flow of a liquid…”, “enabling liquid flow…”, “configured to control a flow rate of liquid…”, etc.). However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
Regarding claim 3, modified Wang discloses the cultivation system of claim 1. Modified Wang further discloses that each of the scaffolds comprises at least two surfaces facing opposite directions along and/or in parallel to a longitudinal axis of said scaffold, and wherein none of the surfaces defines an enclosed perimeter across any cross-section thereof, and the plurality of scaffolds are aligned in the same direction in parallel to the longitudinal axis (Wang; [0111], [0130]-[0140], see Figs. 14-16C at bridge 1740 having grooves and grooves 1720 in the rotor for supporting scaffold screens. When the scaffolds are inserted into the grooves, none of the surfaces of the scaffolds will define an enclosed perimeter across any cross-section, as the scaffolds are spaced apart from each other).
Regarding claim 4, modified Wang discloses the cultivation system of claim 3. Modified Wang further discloses that upon operation of the at least one pump, the liquid flows on at least one surface of each scaffold, within the spaces between neighboring scaffolds, or a combination thereof (Wang; [0111], [0130]-[0140], [0145], see Figs. 11, 14-16C).
Regarding claim 15, modified Wang discloses the cultivation system of claim 1. Modified Wang further discloses that the scaffold unit further comprises a plurality of supportive elements separating each scaffold from its neighboring scaffolds (Wang; [0111], [0130]-[0140], see Figs. 14-16C at bridge 1740 having grooves and grooves 1720 in the rotor for supporting scaffold screens).
Regarding claim 18, modified Wang disclose the cultivation system of claim 4. Modified Wang further discloses that the at least one scaffold unit is disposed within the cell culture bioreactor, so that each of the scaffolds is positioned with the two surfaces being in parallel to a bottom surface of the bioreactor, wherein during the operation of the at least one pump, the liquid passes in parallel to the longitudinal axis within each space along at least one surface of each of the scaffolds, between neighboring scaffolds (Wang; [0111], [0115], [0130]-[0140], see Figs. 14-16C. See also Thon at Fig. 13A. When the scaffold unit of Wang is placed in a bioreactor as in Thon, each of the scaffolds are parallel to a bottom surface of the bioreactor).
Regarding claim 21, modified Wang discloses the cultivation system of claim 1.
Modified Wang fails to explicitly disclose a plurality of pumps, wherein a first pump is configured to deliver liquid into the at least one cell culture bioreactor via the inlet manifold at an inlet flow rate, and wherein a second pump is configured to collect liquid from the cell culture bioreactor via the outlet manifold at an outlet flow rate, and, optionally, wherein a third pump is fluidly coupled to the bioreactor, wherein one or more of the first pump, the second pump, and optionally the third pump control the liquid level within the cell culture bioreactor.
Thon further teaches a plurality of pumps, where a first pump is configured to deliver liquid into the at least one cell culture bioreactor via the inlet manifold at an inlet flow rate, and a second pump is configured to collect liquid from the cell culture bioreactor via the outlet manifold at an outlet flow rate, where one or more of the first pump and second pump control the liquid level within the cell culture bioreactor (Thon; [0007]-[0008], [0128], see Fig. 22). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of modified Wang with the further teachings of Thon to include plurality of pumps, wherein a first pump is configured to deliver liquid into the at least one cell culture bioreactor via the inlet manifold at an inlet flow rate, and wherein a second pump is configured to collect liquid from the cell culture bioreactor via the outlet manifold at an outlet flow rate, wherein one or more of the first pump and the second pump control the liquid level within the cell culture bioreactor, in order to ensure that the bioreactor is filled with enough liquid to cultivate each scaffold within the scaffold unit.
Regarding claim 27, modified Wang discloses the cultivation system of claim 1. Modified Wang further discloses that the liquid is a cell culture medium and that the cultivation system further comprises a medium reservoir for supplying cell culture medium into the at least one cell culture bioreactor, and the medium reservoir is in fluid communication with the at least one cell culture bioreactor (Wang; [0116], see Fig. 14 at reservoir container 1060). The medium reservoir contains a cell culture medium for the cultivation of cells and/or tissues (Wang; [0116], [0155]).
Modified Wang fails to explicitly disclose that the medium reservoir contains a homogenous cell culture medium for the cultivation of cells and/or tissues.
Thon further teaches a medium reservoir that contains a homogenous cell culture medium for the cultivation of cells and/or tissues (Thon; [0009], [00126]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of modified Wang with the further teachings of Thon so that the medium reservoir contains a homogenous cell culture medium for the cultivation of cells and/or tissues, as homogenizing the cell culture medium will ensure that it can be easily pumped from one location to another as desired without the potential for undesired clogging and/or settling.
Regarding claim 32, modified Wang discloses the cultivation system of claim 27. Modified Wang further discloses that the flow rate is controlled according to a measure of at least one parameter selected from the group consisting of dissolved oxygen, pH, nutrient concentration of one or more nutrients, concentration of one or more waste products, and any combination thereof (the system of modified Wang is identical to the instantly claimed invention. Therefore, absent persuasive evidence, the system of modified Wang is capable of having its flow rate controlled according to a measure of at least one of the claimed parameters).
Regarding claim 54, modified Wang discloses the cultivation system of claim 1. Modified Wang further discloses that the liquid level within the cell culture bioreactor is in the range of about 0.1mm to about 100mm above the upper scaffold of the scaffold unit, as the system of modified Wang is identical to the instantly claimed invention. Therefore, absent persuasive evidence, the system of modified Wang is capable of keeping liquid level within the cell culture bioreactor at the claimed range, particularly as Wang teaches parallel flow of culture medium in a bioreactor, where the flow of liquid would be pumped to pass over all scaffolds, i.e. the scaffolds would be immersed in the culture medium (Wang; [0158]-[0170], see Figs. 14-16C). Therefore, the system of Wang would be capable of flowing liquid in this controlled manner, particularly when using the pump that utilizes a controlled flow rate of liquid as in Thon.
Regarding claim 55, modified Wang discloses the cultivation system of claim 54. Modified Wang further discloses that the liquid level is in the range of about 0.1mm to 30mm, as the system of modified Wang is identical to the instantly claimed invention. Therefore, absent persuasive evidence, the system of modified Wang is capable of keeping liquid level within the cell culture bioreactor at the claimed range, particularly as Wang teaches parallel flow of culture medium in a bioreactor, where the flow of liquid would be pumped to pass over all scaffolds, i.e. the scaffolds would be immersed in the culture medium (Wang; [0158]-[0170], see Figs. 14-16C). Therefore, the system of Wang would be capable of flowing liquid in this controlled manner, particularly when using the pump that utilizes a controlled flow rate of liquid as in Thon.
Regarding claim 56, modified Wang discloses the cultivation system of claim 1. Modified Wang further discloses that the flow rate of the liquid flowing through the at least one scaffold unit is in a range of about 0.5 to 50 volume exchanges per day (VVD), as the system of modified Wang is identical to the instantly claimed invention. Therefore, absent persuasive evidence, the system of modified Wang is capable of be capable of flowing liquid in this controlled manner, particularly when using the pump that utilizes a controlled flow rate of liquid as in Thon.
Claims 6, 25, 33, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Thon and Goral as applied to claims 1, 3-4, 15, 18, 21, 27, 32, and 54-56 above, and further in view of Pereira-Taveres et al. (US Pub. No. 2023/0012452; hereinafter Pereira-Taveres; already of record).
Regarding claim 6, modified Wang discloses the cultivation system of claim 1.
Modified Wang fails to explicitly disclose that the thickness of each of the scaffolds ranges from about 1 mm to about 5 cm.
Pereira-Taveres is in the analogous field of bioreactors (Pereira-Taveres [0046]). Pereira-Taveres teaches a scaffold thickness that ranges from about 1 mm to about 5 cm (Pereira-Taveres [0186]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of modified Wang with the teachings of Pereira-Taveres so that the thickness of each of the scaffolds ranges from about 1 mm to about 5 cm, as Pereira-Taveres teaches that this scaffold thickness will be suitable for forming a cell layer (Pereira-Taveres [0186]).
Regarding claim 25, modified Wang discloses the cultivation system of claim 1.
Modified Wang fails to explicitly disclose at least one sensor, wherein said at least one sensor is configured to measure one or more of: liquid level within the cell culture bioreactor; liquid presence within the cell culture bioreactor; and at least one liquid parameter selected from the group consisting of: temperature, pH, dissolved oxygen content, concentration of one or more nutrients, and concentration of one or more waste products, and optionally, a control unit in operative communication with the at least one sensor, configured to receive measurements of one or more of the liquid level, presence, or the at least one liquid parameter, and adjust it based on the measurement thereof.
Pereira-Taveres teaches at least one sensor, where the sensor is configured to measure at least one liquid parameter selected from the group consisting of: temperature, pH, dissolved oxygen content, concentration of one or more nutrients, and concentration of one or more waste products, and optionally, a control unit in operative communication with the at least one sensor, configured to receive measurements of the at least one liquid parameter, and adjust it based on the measurement thereof (Pereira-Taveres; [0003], [0085], [0087]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of modified Wang with the teachings of Pereira-Taveres so that the system further comprises at least one sensor, wherein said at least one sensor is configured to measure at least one liquid parameter selected from the group consisting of: temperature, pH, dissolved oxygen content, concentration of one or more nutrients, and concentration of one or more waste products, and optionally, a control unit in operative communication with the at least one sensor, configured to receive measurements of the at least one liquid parameter, and adjust it based on the measurement thereof, in order to optimize the system for cell growth (Pereira-Taveres; [0003], [0085], [0087]), as well as to determine when old media needs to be replaced with new media (Pereira-Taveres [0244]).
Regarding claim 33, modified Wang discloses the cultivation system of claim 1.
Modified Wang fails to explicitly disclose that the cells are non-human-animal cells, and that the system is for use in producing cultured food products.
Pereira-Taveres teaches a scaffold comprising non-human-animal cells (Pereira-Taveres [0180]), and a system for use in producing cultured food products (Pereira-Taveres [0180]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of modified Wang with the teachings of Pereira-Taveres so that the cells are non-human-animal cells, and that the system is for use in producing cultured food products, as Pereira-Taveres teaches that such a cultivation system can be used to create synthetic meat products (Pereira-Taveres [0180]).
Regarding claim 35, modified Wang discloses the cultivation system of claim 1.
Modified Wang fails to explicitly disclose that the scaffolds are made of at least one edible material.
Pereira-Taveres teaches scaffolds that are made of at least one edible material (Pereira-Taveres [0180]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of modified Wang with the teachings of Pereira-Taveres so that the scaffolds are made of at least one edible material, as scaffolds made of edible material are suitable as the basis for culturing synthetic meat products (Pereira-Taveres [0180]), and will not require the scaffolds to be removed from the cultured product to be suitable for consumption.
Response to Arguments
Applicant's arguments filed June 8, 2026 have been fully considered but they are not persuasive.
Applicant argues on Pgs. 9-15 of their Remarks that neither Wang nor Thon, either alone or in combination, teach the claimed configuration where the pump controls a liquid level above an upper scaffold to be at least 0.1 mm above the upper scaffold. Applicant argues that neither Wang nor Thon describe any control mechanism that references a minimum height relative to a scaffold surface. The Examiner respectfully disagrees. As currently constructed, the claimed language relating to the pump controlling a liquid level is functional language. However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claim. In this case, the system of Wang as modified by Thon is capable of controlling liquid level via a pump as claimed. For a more detailed explanation, please see the rejection of Claim 1 in the Claim Rejections-35 USC 103 section of this instant Office Action. Further, with regards to Applicant’s arguments within the same pages that Wang teaches away from parallel fluid flow, the Examiner respectfully disagrees. Wang specifically teaches parallel flow as an alternate embodiment, which clearly indicates that Wang considered using parallel flow as viable. Further, with regards to Applicant’s arguments that a person having ordinary skill in the art before the effective filing date of their invention would not have been motivated to combine Wang with Thon, as the two systems have incompatible flow architectures, 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).
Further, with regards to Applicant’s arguments on Pgs. 15-18 of their Remarks that the references Pereira-Taveres and Goral do not teach the claimed pump that controls a liquid level, the Examiner asserts that these references have not been used to teach the claimed pump for controlling a liquid level, and that the teachings of Wang in view of Thon have been used to teach these limitations. For a more detailed explanation, please see the rejection of Claim 1 in the Claim Rejections-35 USC 103 section of this instant Office Action.
Conclusion
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.
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/JOHN MCGUIRK/Examiner, Art Unit 1798
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