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 .
Response to Amendment
Rejection of Claim(s) 1-23 under 35 U.S.C. 102(a)(1) as being anticipated by Mehta (WO 2010/008563) has been withdrawn in light of applicant’s amendments.
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.
Claim(s) 1-23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chang (US 2003/0143727).
Regarding claim 1, Chang teaches a cell cultivating device comprising a cell growth chamber (first chamber); a cell trap in fluid communication with the cell growth chamber, wherein the cell trap (second chamber) includes a cell outlet (1646), a cell inlet (1645), and a fluid inlet (1647). Applicants further recite “wherein the cell trap prevents cells from re-entering the cell growth chamber” This limitation is considered a process and/or intended use limitation, which do not further delineate the structure of the claimed apparatus (i.e. from apparatus claim 1) from that of the prior art. Since claim 1, etc. are drawn to an apparatus statutory class of invention, it is the structural limitations of the apparatus, as recited in the claims, which are considered in determining the patentability of the apparatus itself. This recited process or intended use limitation is accorded no patentable weight to an apparatus. Process limitations are not germane to patentability to a structure, which is not distinguished from the prior art. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The cell trap of Chang is capable of preventing cells from re-reentering the cell growth chamber by depressed piston or balloon or 1630. Chang further teaches a fluid flow system (1648) configured to selectively switch between a first mode of operation and a second mode of operation; wherein, in the first mode of operation the fluid flow system is configured to direct fluid through the cell growth chamber towards the cell trap such that cells from the cell growth chamber are collected in the cell trap by entering the cell trap by the cell inlet, and in the second mode of operation the fluid flow system is configured to direct fluid to the cell trap via the fluid inlet and through the cell outlet to thereby harvest cells collected in the cell trap. Chang teaches in paragraphs [138 and 139], “The medium-exchange system is meant to work in two different modes: medium-exchange mode and growth mode. In growth mode, valves 1643 and 1644 are closed, thereby closing connectors 1645 and 1646. Also, valve and air inlet 1647 are open to allow air exchange with the embodiment of FIG. 1 through air filter 160 (not shown). In this state, the growth medium cannot enter nor exit the cell-cultivating device. Once the medium is spent and/or sufficient secreted protein is produced by the cell culture, it is desirable to collect the spent medium for harvesting the protein and also to replenish the spent medium with fresh medium. In medium exchange mode, valve and air inlet 1647 are closed. Further, valve 1643 is closed. Using the remaining gas pressure of the first chamber 110 in cooperation with compressing the second chamber 130 (e.g. bellow), valve 1644 is opened, which allows for the release of the spent medium out through connector 1646 and into storage container 1642. Following release of the spent medium, valve 1644 is closed. Next, by opening valve 1643, a suction is formed to draw the fresh medium contained in a storage container 1641 into second chamber 1630 through connector 1645. This expansion of second chamber 130 draws in fresh medium from storage flask 1641 through connector 1645 into the cell-cultivating device. Once a sufficient amount of fresh medium has been delivered, valve 1643 is closed. To reestablish normal growth mode, valve and air inlet 1647 are opened. All valve controls can be powered by an electronic device such as a computer 1648. The process can be automated or manually operated.”
Regarding claim 2, the system further comprises at least one reservoir (1641) for introducing fluids into the fluid flow system.
Regarding claim 3, in the first mode of operation the fluid flow system is configured to direct fluid from the cell trap towards a fluid waste outlet or back through the cell growth chamber. (Refer to paragraphs [0138 and 0139])
Regarding claim 4, the cell trap comprises a filter (1991) configured to prevent passage of cells towards the fluid waste outlet or back through the cell growth chamber.
Regarding claim 5, in the second mode of operation the fluid flow system is configured such that fluid by-passes the cell growth chamber. (Refer to paragraphs [0138 and 0139])
Regarding claim 6, a valve assembly (1643,1644, and 1647) configured to selectively switch between a first configuration corresponding to the first mode of operation and a second configuration corresponding to the second mode of operation.
Regarding claim 7, in the first configuration the valve assembly is configured to prevent flow of fluid directly to the cell trap without first passing through the cell growth chamber. (refer to paragraph [0046])
Regarding claim 8, in the first configuration the valve assembly is configured to allow flow of fluid from a fluid reservoir to the cell growth chamber. (Refer to paragraphs [0138 and 0139])
Regarding claim 9, in the second configuration the valve assembly is configured to prevent flow of fluid from a fluid reservoir to the cell growth chamber. (Refer to paragraphs [0138 and 0139])
Regarding claim 10, in the second configuration the valve assembly is configured to allow flow of fluid from a fluid reservoir directly to the cell trap. (Refer to paragraphs [0138 and 0139])
Regarding claim 11, the valve assembly (1643,1644, and 1647) comprises a first valve configured to selectively control flow of fluid to the cell growth chamber and the cell trap, and a second valve configured to selectively allow flow of fluid through the cell outlet. (Refer to paragraphs [0138 and 0139])
Regarding claim 12, a by-pass conduit (figure 16) configured for passage of fluid to the cell trap from a fluid reservoir.
Regarding claim 13, a growth chamber inlet conduit (1645) configured for passage of fluid from a fluid reservoir (1641) to the growth chamber (1630).
Regarding claim 14, at least one pump (1743) for pumping fluid through the fluid flow system.
Regarding claim 15, the at least one pump (1743) is not positioned between the cell growth chamber and the cell trap. (figure 17a)
Regarding claim 16, a collection container (1642) fluidly coupled to the cell trap for collecting harvested cells from the cell trap.
Regarding claim 17, the collection container (1642) is detachable from the system.
Regarding claim 18, the cell growth chamber (first chamber) comprises an inlet (1645), an outlet (1646), and one or a plurality of cell culture plates (growth substrate [0072]) positioned between the inlet and the outlet.
Regarding claim 19, the plurality of cell culture plates (growth substrate [0072]) are arranged in a stacked configuration defining a plurality of flow channels through the cell growth chamber, and are oriented such that, in use, cells detached from the cell culture plates travel along the flow channels and through the outlet.
Regarding claim 20, at least one sensor (1648) configured to monitor at least one fluid property of fluid in the system.
Regarding claim 21, a sensor (1648) configured to monitor the volume of cells within the cell trap.
Regarding claim 22, a controller (1648) configured to automatically control the fluid flow system to switch between the first mode of operation and the second mode of operation.
Regarding claim 23, the controller (1648) is configured to automatically switch the fluid flow system to the second mode of operation when a quantity of cells collected in the cell trap reaches a predetermined threshold.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-23 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Refer to rejection above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
/JYOTI Mutreja/ Primary Examiner, Art Unit 1798
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