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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/19/2023 and 04/04/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 102
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 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 1-6 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US2018/0187139 A1-Patel.
Regarding claim 1, Patel discloses a columnar cell culture vessel (Fig. 1a shows vessel 1a having a columnar configuration) comprising: a cylindrical body having a chamber disposed therein (vessel 1 is a cylindrical container, para. [0071], lines 1-3, Fig. 1a) an inlet disposed through one side in an axial direction (inlet port 1a disposed in an axial direction of vessel 1, para. [0065], line 12, Fig. 1), and an outlet disposed through other side in the axial direction (outlet port 1b disposed at the other side of vessel 1 in the axial direction, para. [0065], line 6, Fig. 1);
Patel discloses a support which is filled in the chamber and to which cells are attached to be cultured (support matrix 2 disposed ion the interior of vessel 1, para. [0065], lines 8-10, Fig. 1);
Patel discloses a first cap coupled to the inlet and having an inflow port disposed therethrough (annotated Fig. 3 below shows a similar cap on inlet port 1a);
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Patel discloses and a second cap (annotated Fig. 3 below shows a similar cap on inlet port 1b coupled to outlet 1b) coupled to the outlet and having a discharge port disposed therethrough, wherein a culture solution is introduced into the chamber through the inflow port and discharged out of the chamber through the discharge port (inlet port 1a for introducing nutrient—culture medium and/or biological cells into and an outlet port 1b for discharging the nutrient—culture medium from the vessel 1, para. [0065], lines 4-7).
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Regarding claim 2, Patel discloses wherein the support is a chip or bead made of a polymer or glass having a hydrophilic surface formed through plasma treatment (polymeric materials in form of particles, capsules, fibers, etc., is of particular interest, para. [0113], lines 15-17; further, due to homogenized condition within support matrix, the substrates can be converted into product or other intermediate by constructing said discs 11 such that the enzymes, catalytic proteins or active sites of these proteins are coated, embedded or encapsulated on the surfaces of the discs, para. [0113], lines 20-25).
Regarding claim 3, Patel discloses wherein the support is a polymer chip or bead having a hydrophilic surface formed through protein or chemical coating (polymeric materials in form of particles, capsules, fibers, etc., is of particular interest, para. [0113], lines 15-17; further, due to homogenized condition within support matrix, the substrates can be converted into product or other intermediate by constructing said discs 11 such that the enzymes, catalytic proteins or active sites of these proteins are coated, embedded or encapsulated on the surfaces of the discs, para. [0113], lines 20-25).
Regarding claim 4, Patel discloses wherein the first cap (first cap shown above in annotated Fig. 3) or second cap comprises: a cylindrical body having (the region of 1a is a cylindrical body, shown in annotated Fig. 3 above) a thread disposed therein (annotated Fig. 3 above shows a threaded cap or cover of 1a);
Patel discloses a connection part coaxially protruding outward from the body and having a decreased diameter (shown below in annotated Fig. 3);
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a retention part (shown below in annotated Fig. 3) coaxially protruding outward from the connection part and having a decreased diameter; and a connection port coaxially which protrudes outward from the retention part, has a decreased diameter, and has a Luer-lock tip (the threading region shown in Fig. 1 provides a Luer-lock tip) protruding outward therefrom.
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Regarding claim 5, wherein the first cap or second cap further comprises: a filter coupled inside the connection part to prevent the support from escaping from the chamber: and a fixing ring coupled inside the body to prevent separation of the filter (all valve and conduit attachments are sealed and filtered to keep the entire vessel air/liquid tight and leak proof, para. [0074], lines 6-8; further, the connectors, tubing, filters and closures are attached to the vessel to create the sterility barrier, para. [0074], lines 11-13; various panels sealed via other techniques, para. [0074], lines 8-11; further, port 1a has a ring in the region of the cap shown in annotated Fig. 3 above).
Regarding claim 6, Patel discloses wherein the first cap or second cap comprises a protrusion protruding from the inside of the body to support the fixing ring (shown below in annotated Fig. 3 of Patel).
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Regarding claim 10, Patel discloses wherein the first cap or second cap is replaceable with a closure cap, the closure cap is configured to seal the inlet or outlet, and the support is carriable or storable while being prevented from escaping from the chamber by the closure cap (annotated Fig. 3 above in claim 1, shows a similar cap on inlet port 1b coupled to outlet 1b; further, the support—support matrix 2 disposed ion the interior of vessel 1, para. [0065], lines 8-10, Fig. 1; the support matrix 2 is enclosed by the vessel 1, para. [0071], lines 13-14; further, Fig. 3 shows the support matrix which includes discs 11, cannot escape vessel 1).
Allowable Subject Matter
Claims 7-9 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 7, the prior art fails to teach or fairly suggest wherein the first cap or second cap is replaceable with a recovery cap, the recovery cap is couplable to an entrance/exit port of a storage vessel for recovering the support, and the support is movable to the storage vessel through the recovery cap, where the limitations are in combination with the claim as a whole.
The closest prior is US 2018/0187139 A1-Patel. Patel teaches an invention relating to a bioreactor system and method thereof wherein support matrix (2) comprises at last one central shaft and plurality of peripheral shaft being radially surrounds central shaft. Arrays of discs (11) are mounted along the shaft by defining interspatial vicinities between two successive plates. However, Patel does not teach or fairly suggest wherein the first cap or second cap is replaceable with a recovery cap, the recovery cap is couplable to an entrance/exit port of a storage vessel for recovering the support, and the support is movable to the storage vessel through the recovery cap.
The following is a statement of reasons for the indication of allowable subject matter: for claim 8, the prior art fails to teach or fairly suggest wherein the recovery cap comprises: a cylindrical first body having a thread disposed therein; and a second body which coaxially protrudes outward from the first body, has an increased diameter, and has a thread disposed therein, where the limitations are in combination with the claim as a whole.
The closest prior is US 2018/0187139 A1-Patel. Patel teaches an invention relating to a bioreactor system and method thereof wherein support matrix (2) comprises at last one central shaft and plurality of peripheral shaft being radially surrounds central shaft. Arrays of discs (11) are mounted along the shaft by defining interspatial vicinities between two successive plates. However, Patel does not teach or fairly suggest wherein the recovery cap comprises: a cylindrical first body having a thread disposed therein; and a second body which coaxially protrudes outward from the first body, has an increased diameter, and has a thread disposed therein.
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 second body has a support ring coaxially protruding outward from the inside thereof and having a decreased diameter, and the entrance/exit of the storage vessel is inserted between the first body and the support ring and is supported thereby, where the limitations are in combination with the claim as a whole.
The closest prior is US 2018/0187139 A1-Patel. Patel teaches an invention relating to a bioreactor system and method thereof wherein support matrix (2) comprises at last one central shaft and plurality of peripheral shaft being radially surrounds central shaft. Arrays of discs (11) are mounted along the shaft by defining interspatial vicinities between two successive plates. However, Patel does not teach or fairly suggest wherein the second body has a support ring coaxially protruding outward from the inside thereof and having a decreased diameter, and the entrance/exit of the storage vessel is inserted between the first body and the support ring and is supported thereby.
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