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 12/07/2023 and 10/07/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
The abstract of the disclosure is objected to because the abstract submitted contains more than 150 words. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b). Additionally, it appears a second abstract, also submitted on 12/07/2023 is inappropriate, since it contains a portion of a missing claim and continues with claims 6-8 of the instant application.
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
Claim Objections
Claim 10 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 5. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim 9 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 3. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2, 5-8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0155887 A1-Chiba et al (hereinafter, “Chiba”), and further in view of US 2014/0349385 A1-Erdenberger et al (hereinafter, “Erdenberger”).
Regarding claim 1, Chiba discloses a cell culture device (cell culture device 900, para. [0024], line 1, Fig. 1) comprising: a cell culture vessel (cell culture vessel 100, para. [0024], lines 2-3, Fig. 1) that is a substantially cylindrical body having (a cylindrical body of vessel 100, para. [0024], lines 2-3, Fig. 1), at a lower end (cell culture vessel 100 includes a lower end, para. [0025], line1-3, Fig. 1), a bottom that is flat (cell culture vessel 100 includes a flat bottom part 120, para. [0025], lines 1-2, Fig. 1), and having a hollow space (vessel 100 includes a hollow space 130, para. [0025], lines 3-4, Fig. 1) to be filled with a scaffold for culturing cells (space 130 filled with a scaffold that allows for cells to be cultured, para. [0025], lines 3-5, Fig. 1);
Chiba discloses a dish-shaped body (dish-shaped body 200, para. [0024], line 4, Fig. 1) having, in a periphery, a plurality of first magnetic bodies each made of a ferromagnetic material at equal intervals (the approximately cylindrical body as the cell culture vessel, the dish-shaped body including a plurality of magnetic attraction members made of magnets or ferromagnets arranged at equal intervals at a circumferential portion of the dish shaped body, para. [0009], lines 6-11), the dish-shaped body having a substantially disk shape with a diameter slightly smaller than a diameter of the substantially cylindrical body of the cell culture vessel so as to be disposed horizontally in the hollow space of the cell culture vessel without contact with an inner wall of the cell culture vessel (the dish-shaped body 200 is horizontally arranged in the hollow space of the cell culture vessel 100. The dish-shaped body 200 that is approximately a disc-shaped body has a diameter that is slightly smaller than the diameter of the cell culture vessel 100 that is approximately a cylindrical body, para. [0031], lines 20-25, Fig. 1);
Chibs discloses an annular body (annular body 300, para. [0032], line 1, Fig. 1) having a plurality of second magnetic bodies (magnetic attraction members 310, para. [0032], line 7-8, Fig. 2) each made of a magnet corresponding to an associated one of the first magnetic bodies of the dish-shaped body to attract the first magnetic bodies of the dish-shaped body by a magnetic force (each magnetic attraction member 310 made of magnets, each of which corresponds to associated one of the magnetic attraction members 210 of the dish-shaped body 200, para. [0032], lines 8-10, Fig. 1), the annular body having a substantially ring shape (annular body 300 is a ring-shaped body, para. [0032], line 6-7, Figs. 1 and 2) and positioned outside the cell culture vessel (annular body 300that is approximately a ring-shaped body is positioned outside the cell culture vessel 100 so that the cell culture vessel 100 can be positioned inside the ring, para. [0032], lines 1-4) to have the cell culture vessel located inside a ring of the cell culture vessel (culture vessel 100 can be positioned inside the ring, para. [0032], lines 3-4), the annular body being configured to move upward to cause the dish-shaped body to move upward in conjunction with the annular body due to the magnetic force (annular body 300 is supported by a lifting device 320 and is moved vertically. The annular body 300 is moved vertically, and the dish-shaped body 200 also moves vertically since the dish-shaped body 200 moves in conjunction with the annular body 300 due to a magnetic force, para. [0034], lines 1-5), thereby pushing up the scaffold that fills the hollow space of the cell culture vessel from below, and move downward to cause the dish-shaped body to move downward in conjunction with the annular body due to the magnetic force, thereby making the scaffold that fills the hollow space of the cell culture vessel fall by gravity (when the dish - shaped body 200 is moved upward , the scaffold filling the hollow space 130 of the cell culture vessel 100 and the cells adhered to the scaffold are pushed up from below by the dish-shaped body 200 and moved upward, para. [0039], lines 9-13; when the dish-shaped body 200 moves down ward, the scaffold and the cells adhered to the scaffold fall with gravity, para. [0041], lines 5-7).
Regarding claim 1, Chiba teaches the invention discussed above. Further, Chiba also teaches an annular body and that moves downward. However, Chiba does not explicitly teach a storage made of a ferromagnetic material and configured to store the annular body.
For claim 1, Erdenberger teaches systems may comprise vessels and/or unit operations or components of cell culture, cell containment, bioreactor (para. [0236], lines 10-12), and Erdenberger teaches a ferromagnetic plate 219 (where the plate thus facilitates storage of the bottom of the vessel) can be inserted beneath the bag support structure wall, para. [0235], lines 17-18), which reads on the instant claim limitation of teach a storage made of a ferromagnetic material and configured to store the annular body.
It would have been obvious to one of ordinary skill, in the art at the time, to further include a storage made of a ferromagnetic material and configured to store the annular body as taught by Erdenberger, because Erdenberger teaches the ferromagnetic plate to provide an attractive coupling force for the encapsulated magnets 2804 (para. [0235], lines 18-19).
Regarding claim 2, Chiba teaches the invention discussed above in claim 1. Further, Chiba teaches an annular body. However, Chiba does not explicitly teach a storage which includes a bottom peripheral wall and an outer peripheral wall and an inner peripheral wall provided inside the bottom peripheral wall.
For claim 2, Erdenberger teaches systems may comprise vessels and/or unit operations or components of cell culture, cell containment, bioreactor (para. [0236], lines 10-12), and Erdenberger teaches a ferromagnetic plate (where the plate thus facilitates storage of the bottom of the vessel) can be inserted beneath the bag support structure wall, para. [0235], lines 17-18), additionally, Fig. 2 shows plate 219 having a bottom peripheral wall (the bottom of plate 219, Fig. 2); outer peripheral wall (the outer region or outside of plate 129, shown in Fig. 2), inner peripheral wall (the inside of plate 219, shown in Fig. 2), which reads on the instant claim limitation of a storage which includes a bottom peripheral wall and an outer peripheral wall and an inner peripheral wall provided inside the bottom peripheral wall.
It would have been obvious to one of ordinary skill, in the art at the time, to further include a storage made of a ferromagnetic material and configured to store the annular body as taught by Erdenberger, because Erdenberger teaches the ferromagnetic plate to provide an attractive coupling force for the encapsulated magnets 2804 (para. [0235], lines 18-19).
Regarding claim 5, Chiba discloses wherein the housing (depicted below in annotated Fig. 2a, denoted 2a for distinguishing purposes) includes a columnar hollow portion that extends in a radial direction of the annular body (Fig. 2 below shows a columnar hollow portion extending in a radial direction of annular body 300, Fig. 2) and a widened portion (depicted below in annotated Fig. 2b, denoted 2b for distinguishing purposes) positioned radially outside the columnar hollow portion, the columnar hollow portion restricting a motion of the second magnetic bodies (shown in Fig. 2 and annotated Fig. 2 below, magnetic body 310 is restricted in motion) other than sliding in a radial direction of each of the second magnetic bodies due to close contact between an inner surface of the columnar hollow portion and an outer surface of each of the second magnetic bodies.
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Regarding claim 6, Chiba discloses wherein each of the second magnetic (magnetic bodies 310, Fig. 2) bodies has a stopper (shown below in annotated Fig. 2) at an outer end in the radial direction of the annular body, the stopper being positioned in the widened portion, the widened portion has a larger cross-sectional area perpendicular to the radial direction of the annular body than the stopper (shown below in annotated Fig. 2), and the stopper has a larger cross-sectional area perpendicular to the radial direction of the annular body than the columnar hollow portion (show above in annotated Fig. 2b).
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Regarding claim 7, Chiba discloses wherein the scaffold that fills the cell culture vessel (cell culture vessel 100 includes a hollow space 130 filled with a scaffold, para. [0025], lines 3-4) is an aggregate of a plurality of small pieces supporting cells (the scaffold is made of an aggregate of a plurality of small pieces that support the cells, para. [0030], lines 12-13).
Regarding claim 8, Chiba discloses wherein the cells to be cultured are mesenchymal stem cells (the cells to be cultured are not limited to any particular cells, para. [0026], lines 1-2; bone marrow-derived mesenchymal stem cells, para. [0026], line 7).
Regarding claim 10, Chiba discloses wherein the housing (depicted below in annotated Fig. 2a, denoted 2a for distinguishing purposes) includes a columnar hollow portion that extends in a radial direction of the annular body (Fig. 2 below shows a columnar hollow portion extending in a radial direction of annular body 300, Fig. 2) and a widened portion (depicted below in annotated Fig. 2b, denoted 2b for distinguishing purposes) positioned radially outside the columnar hollow portion, the columnar hollow portion restricting a motion of the second magnetic bodies (shown in Fig. 2 and annotated Fig. 2 below, magnetic body 310 is restricted in motion) other than sliding in a radial direction of each of the second magnetic bodies due to close contact between an inner surface of the columnar hollow portion and an outer surface of each of the second magnetic bodies.
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Allowable Subject Matter
Claims 3-4, 9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: for claim 3, the prior art fails to teach or fairly suggest wherein the annular body includes a housing in which each of the second magnetic bodies is housed with a gap so as to be radially slidable, and a plurality of third magnetic bodies each made of a ferromagnetic material and corresponding to an associated one of the second magnetic bodies, the third magnetic bodies being provided on a radially outer side of the housing, when the annular body moves downward below the bottom of the cell culture vessel and is stored in the storage, the second magnetic bodies are attracted to the third magnetic bodies due to the magnetic force to slide in the housing and move radially outward, and when the annular body moves up and above the bottom of the cell culture vessel to be aligned with the dish-shaped body, the second magnetic bodies are attracted to the first magnetic bodies due to the magnetic force to slide in the housing and move radially inward, where these limitations are in combination with the claim as a whole.
The closest prior US 2021/0155887 A1-Chiba et al (hereinafter, “Chiba”), and US 2014/0349385 A1-Erdenberger et al (hereinafter, “Erdenberger”). Chiba teaches an invention relating to a cell culture device that allows for medium agitation as well as the supply of nutrients to cells and oxygenation of the cells with simple operations, thereby enabling mass cell culture. Erdenberger teaches an invention relating to several improvements over existing magnetic agitation mixing systems for use with flexible container reaction vessels. However, Chiba and Erdenberger does not teach or fairly suggest wherein the annular body includes a housing in which each of the second magnetic bodies is housed with a gap so as to be radially slidable, and a plurality of third magnetic bodies each made of a ferromagnetic material and corresponding to an associated one of the second magnetic bodies, the third magnetic bodies being provided on a radially outer side of the housing, when the annular body moves downward below the bottom of the cell culture vessel and is stored in the storage, the second magnetic bodies are attracted to the third magnetic bodies due to the magnetic force to slide in the housing and move radially outward, and when the annular body moves up and above the bottom of the cell culture vessel to be aligned with the dish-shaped body, the second magnetic bodies are attracted to the first magnetic bodies due to the magnetic force to slide in the housing and move radially inward.
The following is a statement of reasons for the indication of allowable subject matter: for claim 4, the prior art fails to teach or fairly suggest wherein a mass of each of the three magnetic bodies is smaller than a mass of each of the first magnetic bodies, where these limitations are in combination with the claim as a whole.
The closest prior US 2021/0155887 A1-Chiba et al (hereinafter, “Chiba”), and US 2014/0349385 A1-Erdenberger et al (hereinafter, “Erdenberger”). Chiba teaches an invention relating to a cell culture device that allows for medium agitation as well as the supply of nutrients to cells and oxygenation of the cells with simple operations, thereby enabling mass cell culture. Erdenberger teaches an invention relating to several improvements over existing magnetic agitation mixing systems for use with flexible container reaction vessels. However, Chiba and Erdenberger does not teach or fairly suggest wherein a mass of each of the three magnetic bodies is smaller than a mass of each of the first magnetic bodies.
The following is a statement of reasons for the indication of allowable subject matter: for claim 9, the prior art fails to teach or fairly suggest wherein the annular body includes a housing in which each of the second magnetic bodies is housed with a gap so as to be radially slidable, and a plurality of third magnetic bodies each made of a ferromagnetic material and corresponding to an associated one of the second magnetic bodies, the third magnetic bodies being provided on a radially outer side of the housing, when the annular body moves downward below the bottom of the cell culture vessel and is stored in the storage, the second magnetic bodies are attracted to the third magnetic bodies due to the magnetic force to slide in the housing and move radially outward, and when the annular body moves up and above the bottom of the cell culture vessel to be aligned with the dish-shaped body, the second magnetic bodies are attracted to the first magnetic bodies due to the magnetic force to slide in the housing and move radially inward, where these limitations are in combination with the claim as a whole.
The closest prior US 2021/0155887 A1-Chiba et al (hereinafter, “Chiba”), and US 2014/0349385 A1-Erdenberger et al (hereinafter, “Erdenberger”). Chiba teaches an invention relating to a cell culture device that allows for medium agitation as well as the supply of nutrients to cells and oxygenation of the cells with simple operations, thereby enabling mass cell culture. Erdenberger teaches an invention relating to several improvements over existing magnetic agitation mixing systems for use with flexible container reaction vessels. However, Chiba and Erdenberger does not teach or fairly suggest wherein the annular body includes a housing in which each of the second magnetic bodies is housed with a gap so as to be radially slidable, and a plurality of third magnetic bodies each made of a ferromagnetic material and corresponding to an associated one of the second magnetic bodies, the third magnetic bodies being provided on a radially outer side of the housing, when the annular body moves downward below the bottom of the cell culture vessel and is stored in the storage, the second magnetic bodies are attracted to the third magnetic bodies due to the magnetic force to slide in the housing and move radially outward, and when the annular body moves up and above the bottom of the cell culture vessel to be aligned with the dish-shaped body, the second magnetic bodies are attracted to the first magnetic bodies due to the magnetic force to slide in the housing and move radially inward.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LENORA A. ABEL whose telephone number is (571)272-8270. The examiner can normally be reached Monday-Friday 7:00am-4:00pm.
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/L.A.A./ Examiner, Art Unit 1799
/MICHAEL L HOBBS/ Primary Examiner, Art Unit 1799
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