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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/6/24 is being considered by the examiner.
Claim Status
Claims 69-88 are pending and are examined. Claims 1-68 are cancelled.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 69, 70, 71, 72, 75, 76, 77, 78, 80, 81, 82, 83, 84, 85, 86, and 87 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang (EP 3505613).
Regarding Claim 69, Wang teaches an apparatus (FIG. 2A and FIG. 2B are schematic views of a cell culture carrier of a cell culture module) comprising:
a) a vessel having an exterior surface and an interior surface defining a sealed cell culture chamber, the vessel having a longitudinal axis, and a plurality of fluid inlet ports and a plurality of fluid outlet ports (cell culture module 100A may be disposed on one end portion of the reactor 110. When only one single inlet/outlet T12 is disposed in the cell culture module 100A, the inlet/outlet T12 may be used both for entry and exit of a liquid such as a culture medium and a buffer solution and for cell collection.);
b) a cell scaffold secured to a mount, wherein the mount and the cell scaffold are disposed within the sealed cell culture chamber and configured to move along a longitudinal axis of the vessel, wherein the cell scaffold is not fixed to the sealed cell culture chamber, wherein the mount comprises a magnetically responsive material (FIG. 1A and FIG. 1B are respectively schematic views of cell culture carriers of a cell culture module in a twisted state and an untwisted state according to an exemplary embodiment. Referring to FIG. 1A and FIG. 1B, a cell culture module 100A of the present embodiment includes a reactor 110, a first fixer 120, a second fixer 130A and a plurality of cell culture carriers 140. The reactor 110 has a chamber C10 and at least one inlet/outlet T12. The chamber C10 is configured to provide space for culturing cells. The inlet/outlet T12 communicates with the chamber C10. The first fixer 120 is fixed to the reactor 110 and located in the chamber C10. The second fixer 130A is disposed in the chamber C10 and is movable relative to the first fixer 120. Two ends of the cell culture carriers 140 are respectively fixed to the first fixer 120 and the second fixer 130A.); and
c) one or more external magnets disposed along the exterior surface of the vessel and configured to magnetically engage the mount upon coupling to the magnetically responsive material (Figs. 2A and 2B, it should be noted that the cell culture module 100B of the present embodiment further includes a magnetic control part 160A. Correspondingly, a second fixer 130B of the present embodiment has magnetism. Accordingly, the magnetic control part 160A may control the second fixer 130B to move, using magnetic force such as magnetic attractive force or magnetic repulsive force. As shown in FIG. 2A, when the magnetic control part 160A magnetically controls the second fixer 130B to move to a position away from the first fixer 120, the cell culture carriers 140 are rendered in the untwisted state. As shown in FIG. 2B, when the magnetic control part 160A controls the second fixer 130B to move to a position close to the first fixer 120, the cell culture carriers 140 are rendered in the twisted state.).
Regarding Claim 70, Wang teaches the apparatus of claim 69, wherein the mount and the cell scaffold are configured to be selectively movable between at least a first position and a second position relative to the vessel along the longitudinal axis (In the present embodiment, since the second fixer 130A is movably disposed in the chamber C10, when the reactor 110 is placed in the state of FIG. 1A, the second fixer 130A moves downward to a position close to the first fixer 120 due to its own gravity.).
Regarding Claim 71, Wang teaches the apparatus of claim 69, wherein the vessel is cylindrical in shape and has a top end and a bottom end (the reactor of the cell culture module is cylindrical, but is not limited thereto.), wherein the bottom end is removably fixed to a base mechanism, and the top end is removable (The second fixer 130 is disposed in the chamber C10 and is movable relative to the first fixer 120.).
Regarding Claim 72, Wang teaches the apparatus of claim 71, wherein the base mechanism is configured to move relative to the mount and the cell scaffold (The second fixer 130A is disposed in the chamber C10 and is movable relative to the first fixer 120.).
Regarding Claim 75, Wang teaches the apparatus of claim 69, wherein the mount is configured to be selectively movable relative to the vessel between at least a first position and a second position along the longitudinal axis (The sheet-shaped carrier member is in an open state or a folded state according to a variation in a distance between the first fixer and the second fixer due to a movement of the second fixer), and wherein movement of the one or more external magnets between the first position and the second position is capable of moving the mount within the sealed cell culture chamber between the first position and the second position (Moreover, the magnetic control part 160A itself is movable, thereby driving the second fixer 130B to move.).
Regarding Claim 76, Wang teaches the apparatus of claim 69, wherein the cell scaffold comprises one or more of a plurality of hollow fibers, flat sheet membrane, matrix, cage with macro carriers, and porous membrane bag with macro carriers, or any combination thereof (A material of the cell culture carriers 140 includes, for example, polyester (PET), nylon, polyethylene (PE), polypropylene (PP), polyvinyl chloride (PVC), polystyrene (PS), polycarbonate (PC), ethylene vinyl acetate (EVA), polyurethane (PU) or the like. However, the disclosure is not limited thereto, and any material having fiber drawing properties may be used as the material for the cell culture carrier of the disclosure. In addition, each of the cell culture carriers 140 may be in the shape of a striped sheet, a threadlike sheet, or in any other suitable shape.).
Regarding Claim 77, Wang teaches the apparatus of claim 76, wherein the plurality of hollow fibers, flat sheet membrane, matrix, cage with macro carriers, and porous membrane bag with macro carriers comprise a surface configured to receive cell seeding (A material of the cell culture carriers 140 includes, for example, polyester (PET), nylon, polyethylene (PE), polypropylene (PP), polyvinyl chloride (PVC), polystyrene (PS), polycarbonate (PC), ethylene vinyl acetate (EVA), polyurethane (PU) or the like. However, the disclosure is not limited thereto, and any material having fiber drawing properties may be used as the material for the cell culture carrier of the disclosure. In addition, each of the cell culture carriers 140 may be in the shape of a striped sheet, a threadlike sheet, or in any other suitable shape. The surface would be capable of receiving cell seeding).
Regarding Claim 78, Wang teaches the apparatus of claim 76, wherein the plurality of hollow fibers are semipermeable and define an intracapillary space and an extracapillary space, and wherein the intracapillary space is configured to contain a first fluid, and the extracapillary space is configured to contain a second fluid ((the disclosure is not limited thereto, and any material having fiber drawing properties may be used as the material for the cell culture carrier of the disclosure. The spaces would be configured to have a first fluid or a second fluid).
Regarding Claim 80, Wang teaches the apparatus of claim 69, wherein the plurality of fluid inlet ports and the plurality of fluid outlet ports are individually controlled to regulate liquid and gas flow (The casing has a chamber (C10) and at least one inlet/outlet (T12, T14, T16, T18, T21, T23). See Abstract).
Regarding Claim 81, Wang teaches the apparatus of claim 69, wherein the mount has a top surface and a bottom surface (the mount inherently has a top surface and a bottom surface), and the cell scaffold is removably secured to the bottom surface of the mount (The second fixer is disposed in the chamber and is movable relative to the first fixer.).
Regarding Claim 82, Wang teaches the apparatus of claim 69, wherein the vessel further comprises a sampling port configured for aseptically extracting cell culture media (The casing has a chamber (C10) and at least one inlet/outlet (T12, T14, T16, T18, T21, T23). See Abstract).
Regarding Claim 83, Wang teaches a cell scaffold cartridge comprising: a mount configured to be disposed within a cell culture chamber of a vessel and move along a longitudinal axis of the vessel (The second fixer is disposed in the chamber and is movable relative to the first fixer.), wherein the mount comprises a magnetically responsive material (Correspondingly, a second fixer 130B of the present embodiment has magnetism. Accordingly, the magnetic control part 160A may control the second fixer 130B to move, using magnetic force such as magnetic attractive force or magnetic repulsive force. As shown in FIG. 2A, when the magnetic control part 160A magnetically controls the second fixer 130B); and a cell scaffold secured to the mount and configured to move along the longitudinal axis of the vessel, wherein the cell scaffold is not fixed to the cell culture chamber (The first fixer is fixed to the casing and located in the chamber. The first fixer is not fixed to the chamber since it is located in the chamber).
Regarding Claim 84, Wang teaches the cell scaffold cartridge of claim 83, wherein the mount has a top surface and a bottom surface (the mount inherently has a top surface and a bottom surface), wherein the cell scaffold is removably secured to the bottom surface of the mount (The second fixer is disposed in the chamber and is movable relative to the first fixer.).
Regarding Claim 85, Wang teaches the cell scaffold cartridge of claim 83, wherein the cell scaffold is one or more of a plurality of hollow fibers, flat sheet membrane, matrix, cage with macro carriers, porous membrane bag with macro carriers, or any combination thereof (A material of the cell culture carriers 140 includes, for example, polyester (PET), nylon, polyethylene (PE), polypropylene (PP), polyvinyl chloride (PVC), polystyrene (PS), polycarbonate (PC), ethylene vinyl acetate (EVA), polyurethane (PU) or the like. However, the disclosure is not limited thereto, and any material having fiber drawing properties may be used as the material for the cell culture carrier of the disclosure. In addition, each of the cell culture carriers 140 may be in the shape of a striped sheet, a threadlike sheet, or in any other suitable shape.).
Regarding Claim 86, Wang teaches the cell scaffold cartridge of claim 85, wherein the plurality of hollow fibers, flat sheet membrane, matrix, cage with macro carriers, and porous membrane bag with macro carriers comprise a surface configured to receive cell seeding (the surface would be capable of receiving cell seeding. It is also taught by Wang that this is a cell culture carrier thus indicating it carries cell).
Regarding Claim 87, Wang teaches the cell scaffold cartridge of claim 83, wherein the plurality of hollow fibers are semipermeable and define an intracapillary space and an extracapillary space, and wherein the intracapillary space is configured to contain a first fluid, and the extracapillary space is configured to contain a second fluid (the disclosure is not limited thereto, and any material having fiber drawing properties may be used as the material for the cell culture carrier of the disclosure. The spaces would be configured to have a first fluid or a second fluid).
Claim Rejections - 35 USC § 103
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 73 and 74 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (EP 3505613), in view of Eberhart (US Pub 2015/0024436).
Regarding Claims 73 and 74, Wang teaches the apparatus of claim 71.
Wang is silent to the top end of the vessel comprises a magnet and is configured to magnetically engage the mount with a stronger force than the one or more external magnets to secure the mount in the vessel and the magnet comprises one or more of an electromagnet, a strong magnet, a permanent magnet, and a neodymium magnet.
Eberhart teaches on the related art of a sample system for biological system. [0192] In some embodiments, the cassette further comprises a magnetic field application member adjacent to the thermocycling chamber. The magnetic field application member may be configured to apply a magnetic field using a permanent magnet or an electromagnet, in which case the magnetiic field application member includes a permanent magnet or an electromagnet. A permanent magnet can be comprised in the sample cartridge. Alternatively, the magnetic field application member can be a moveable magnet (e.g., permanent magnet or electromagnet) that can be moved to become adjacent to the thermocycling chamber.
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 added a magnet and is configured to magnetically engage the mount with a stronger force than the one or more external magnets to secure the mount in the vessel and the magnet comprises one or more of an electromagnet, a strong magnet, or a permanent magnet, as taught by Eberhart, in the device of Wang, to allow for magnetic beads to be used for cell selection.
Claims 79 and 88 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (EP 3505613), in view of Wang (CN 101199436).
Regarding Claims 79 and 88, Wang (EP ‘613) teaches the apparatus of claim 69.
Wang (EP ‘613) is silent to the mount defines a plurality of holes extending therethrough substantially along the longitudinal axis, and wherein the plurality of holes is of a size to permit the transport of a gas or a nutrient therethrough and prevent the transport of a cell therethrough.
Wang (CN ‘436) teaches in the related art of cell substrates. See Fig. 6 for passage through porous material on the longitudinal axis.
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 added a plurality of holes extending therethrough substantially along the longitudinal axis, as taught by Wang (CN ‘436), to the mount in the device of Wang (EP ‘613), to allow for separating of different sized cells.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE BRAZIN whose telephone number is (571)270-1457. The examiner can normally be reached M-F 8-5.
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/JB/
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798