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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-23 in the reply filed on 3/9/2026 is acknowledged.
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 Mehta (WO 2010/008563).
Regarding claim 1, Metha teaches a bioreactor comprising a cell growth chamber (chamber 5); a cell trap (fluidized bed) in fluid communication with the cell growth chamber, the cell trap including a cell outlet; and a fluid flow system 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, and in the second mode of operation the fluid flow system is configured to direct fluid to the cell trap and through the cell outlet to thereby harvest cells collected in the cell trap. (Refer to claims 1 -6 and claims 22 and 26) (Refer to paragraphs [0114-0119])
Regarding claim 2, the system further comprises at least one reservoir (16) for introducing fluids into the fluid flow system.
Regarding claim 3, wherein 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 [0121-0125])
Regarding claim 4, the cell trap comprises a filter configured to prevent passage of cells towards the fluid waste outlet or back through the cell growth chamber. (Refer to paragraphs [0121-0125])
Regarding claim 5, wherein in the second mode of operation the fluid flow system is configured such that fluid by-passes the cell growth chamber. (Refer to paragraphs [0121-0125])
Regarding claim 6, a valve assembly 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. (Refer to paragraphs [0121-0125])
Regarding claim 7, wherein 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 paragraphs [0121-0125])
Regarding claim 8, wherein in the first configuration the valve assembly is configured to allow flow of fluid from a fluid reservoir to the cell growth chamber.
Regarding claim 9, wherein 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 [0121-0125])
Regarding claim 10, wherein 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 [0114-0119])
Regarding claim 11, the valve assembly 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 [0114-0119])
Regarding claim 12, a by-pass conduit configured for passage of fluid to the cell trap from a fluid reservoir. (Refer to paragraphs [0114-0119])
Regarding claim 13, a growth chamber inlet conduit configured for passage of fluid from a fluid reservoir to the growth chamber. (Refer to claims 1 -6) (Refer to paragraphs [0114-0119])
Regarding claim 14, at least one pump (3) for pumping fluid through the fluid flow system.
Regarding claim 15, wherein the at least one pump (3) is not positioned between the cell growth chamber and the cell trap.
Regarding claim 16, a collection container (9) fluidly coupled to the cell trap for collecting harvested cells from the cell trap. (Refer to Figure 12)
Regarding claim 17, the collection container (9) is detachable from the system.
Regarding claim 18, the cell growth chamber (5) comprises an inlet, an outlet, and one or a plurality of cell culture plates positioned between the inlet and the outlet. (Refer to paragraph [0107])
Regarding claim 19, the plurality of cell culture plates 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. (Refer to Figure 7)
Regarding claim 20, at least one sensor configured to monitor at least one fluid property of fluid in the system. (Refer to paragraphs [0150-0151])
Regarding claim 21, a sensor configured to monitor the volume of cells within the cell trap. (Refer to paragraphs [0150-0151])
Regarding claim 22, a controller configured to automatically control the fluid flow system to switch between the first mode of operation and the second mode of operation. (Refer to claims 1 -6 and claims 22 and 26) (Refer to paragraphs [0114-0119])
Regarding claim 23, the controller 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. (Refer to claims 1 -6 and claims 22 and 26) (Refer to paragraphs [0114-0119])
Conclusion
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/JYOTI Mutreja/Primary Examiner, Art Unit 1798
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