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 .
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1-4, 6, 15, 18-19, 21, 24-25, 27, 32-33, and 35, drawn to a cultivation system for cell and/or tissue cultivation comprising at least one cell culture bioreactor comprising an inlet manifold, an outlet manifold, and at least one scaffold comprising a plurality of scaffolds.
Group II, claim(s) 36-37, 40, 42, and 48-49, drawn to a method for producing at least one scaffold unit comprising a plurality of scaffolds comprising cultured cells and/or tissues.
Group III, claim(s) 50-53, drawn to a bioreactor configured to deliver a liquid to a plurality of scaffolds, the bioreactor comprising a plurality of cultivation trays and at least one mixing apparatus.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I-III lack unity of invention because even though the inventions of these groups require the technical feature of a bioreactor comprising: (a) at least one bioreactor wall defining an internal chamber and is extending between a bottom surface and an upper surface, wherein the bioreactor is configured to deliver the liquid to a plurality of scaffolds disposed therein, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Orr et al. (US Pub. No. 2008/0293135; hereinafter Orr).
Orr teaches a bioreactor ([0006]). The bioreactor comprises: (a) at least one bioreactor wall defining an internal chamber and is extending between a bottom surface and an upper surface ([0052], see Fig. 2 at culture chambers 10). The bioreactor is configured to deliver the liquid to a plurality of scaffolds disposed therein (The bioreactor needs only to be capable of delivering liquid to a plurality of scaffolds disposed therein to satisfy the claim language, and the plurality of scaffolds are not positively recited. Nevertheless, Orr teaches delivering liquid to a plurality of scaffolds disposed in an internal chamber at [0052], see Fig. 2 at culture chambers 10 each containing a plurality of discrete scaffolds 15).
Note: The instant Claims contain functional language (ex: “configured to deliver the liquid to a plurality of scaffolds disposed therein…”). 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.
During a telephone conversation with Michael Scher on 3/3/2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-4, 6, 15, 18-19, 21, 24-25, 27, 32-33, and 35. Affirmation of this election must be made by applicant in replying to this Office action. Claims 36-37, 40, 42, and 48-53 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species or invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention or species may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected invention or species.
Should applicant traverse on the ground that the inventions have unity of invention (37 CFR 1.475(a)), applicant must provide reasons in support thereof. Applicant may submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. Where such evidence or admission is provided by applicant, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claim Status
Claims 1-4, 6, 15, 18-19, 21, 24-25, 27, 32-33, 35-37, 40, 42, and 48-53 are pending, with claims 1-4, 6, 15, 18-19, 21, 24-25, 27, 32-33, and 35 being examined, and claims 36-37, 40, 42, and 48-53 deemed withdrawn. Claims 5, 7-14, 16-17, 20, 22-23, 26, 28-31, 34, 38-39, 41, and 43-47 are canceled.
Information Disclosure Statement
The information disclosure statement (IDS) received on 8/14/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 4 and 27 are objected to because of the following informalities:
Regarding claim 4, the claim does not end in a period, which is improper. See MPEP 608.01(m).
Regarding claim 27, Ln. 27 recites, “wherein said cultivation system , further comprising…”, which is grammatically incorrect. It appears that the above limitation needs to be amended to recite, “wherein said cultivation system further comprises…” to be grammatically correct.
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 1-4, 15, 18, 21, 24, 27, and 32 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 on the IDS received 8/14/2023) in view of Thon et al. (WO Pub. No. 2020/018950; hereinafter Thon; already of record on the IDS received 8/14/2023).
Regarding claim 1, Wang discloses a cultivation system for cell and/or tissue cultivation ([0111], [0130]-[0140], see Figs. 14-16C). comprising:
at least one cell culture bioreactor ([0111], [0130]-[0140], see Figs. 14-16C). The bioreactor comprises:
an internal chamber configured to accommodate therein at least one scaffold unit ([0111], [0130]-[0140], see Figs. 14-16C at rotor chamber 1600 housing rotor 1700).
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).
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.
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). 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]).
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 the 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 2, modified Wang discloses the cultivation system of claim 1. Modified Wang further discloses at least one pump (Wang; [0145], see Fig. 11 at pump 1140).
Modified Wang fails to explicitly disclose that the manifolds are fluidly coupled to the at least one pump, and wherein 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.
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 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).
Regarding claim 3, modified Wang discloses the cultivation system of claim 2. 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 (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 2.
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 24, modified Wang discloses the cultivation system of claim 21. Modified Wang further discloses that the liquid level within the cell culture bioreactor is at least about 0.1 mm above the upper scaffold of the scaffold unit (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).
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).
Claims 6, 25, 33, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Thon as applied to claims 1-4, 15, 18, 21, 24, 27, and 32 above, and further in view of Pereira-Taveres et al. (US Pub. No. 2023/0012452; hereinafter Pereira-Taveres).
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.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Thon as applied to claims 1-4, 15, 18, 21, 24, 27, and 32 above, and further in view of Goral (US Pub. No. 2020/0181553).
Regarding claim 19, modified Wang discloses the cultivation system of claim 2.
Modified Wang fails to explicitly disclose 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.
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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to John McGuirk whose telephone number is (571)272-1949. The examiner can normally be reached M-F 8am-530pm.
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/JOHN MCGUIRK/Examiner, Art Unit 1798