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 with traverse of Group 1 (claims 1-16) in the reply filed on 03/09/2026 is acknowledged. The traversal is on the ground(s) that Ladtkow does not teach a magnetic cell isolation holder or a stopcock manifold of a call processing kit. This is not found persuasive because these limitations are not positively recited and deemed to read on the slot formed around the perimeter of the bottom portion capable of receiving a magnetic cell isolation holder (Figs. 9-10) and the inlet port 804 is capable of receiving a stopcock manifold (Figs. 9-10), respectively.
The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/24/2023, 07/31/2023, 02/05/2024, 06/04/2025, 10/28/2025, 03/05/2026 were filed after the mailing date of the FAOM. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is 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 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ladtkow et al (US20160296943A1 published 10/13/2016; hereinafter Ladtkow).
Regarding claim 1, Ladtkow teaches an apparatus for magnetic cell isolation comprising:
a base (a bottom portion 816 – Fig. 10 and paragraph 56);
a stopcock manifold interface located on the base (an inlet port 804 located on the bottom portion 816 – Fig. 10 and paragraph 56) and configured to receive a stopcock manifold of a cell processing kit (the inlet port 804 is capable of receiving a stopcock manifold – Fig. 9-10);
a magnetic field generator located within the base (magnets 832A-I located in the bottom portion 816 – Fig. 10); and
a slot formed in the base (a slot formed around the perimeter of the bottom portion – Figs. 9-10), the slot configured to removably receive a magnetic cell isolation holder (the slot is capable of removably receiving a magnetic cell isolation holder – Figs. 9-10);
wherein the magnetic field generator is movable into and out of engagement with the magnetic cell isolation holder (the magnets 832A-I are capable of moving into and out of engagement with a removable magnetic cell isolation holder – Figs. 9-10).
Regarding claim 2, Ladtkow teaches the apparatus of claim 1 wherein the magnetic cell isolation holder is a removable handle that contains a magnetic retention element (the slot is capable of removably receiving a removable handle that contains a magnetic retention element – Figs. 9-10).
Regarding claim 3, Ladtkow teaches the apparatus of claim 2 wherein the magnetic retention element is a column (the slot is capable of removably receiving a removable handle that contains a column – Figs. 9-10).
Claims 1, 5-6, 10, 12-13, and 15-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Griffin et al (WO2019106207A1 published 06/06/2019; hereinafter Griffin)
Regarding claim 1, Griffin teaches an apparatus for magnetic cell isolation comprising:
a base (a base 910 – Fig. 78);
a stopcock manifold interface located on the base (a central portion of the base 910 – Fig. 78) and configured to receive a stopcock manifold of a cell processing kit (the central portion of the base 910 holding a stopcock manifold 918);
a magnetic field generator located within the base (the base includes a magnetic field generator 962 of a magnetic cell isolation holder 960 – paragraph 249 and Fig. 78); and
a slot formed in the base (a slot between the top and bottom of the base 910 – Fig. 78), the slot configured to removably receive a magnetic cell isolation holder (the slot is capable of receiving the magnetic cell isolation holder 960 – paragraph 249);
wherein the magnetic field generator is movable into and out of engagement with the magnetic cell isolation holder (The magnetic cell isolation holder 960 may be removably coupled to a magnetic field generator 962 – paragraph 249).
Regarding claim 5, Griffin teaches the apparatus of claim 1 wherein the stopcock manifold interface comprises: a plurality of stopcock pins driven by at least one stopcock motor within the base (a respective actuator of a pinch valve array – paragraph 113).
Regarding claim 6, Griffin teaches the apparatus of claim 5 wherein the plurality of stopcock pins includes six stopcock pins driven by six stopcock motors (at least six pinch valves pinch valves of the flow with respective actuators (e.g., solenoids) that operate/act against a corresponding anvil while the fluid path/line is in between to “pinch off’ the line to prevent fluid flow therethrough – paragraph 133) (the actuator and anvil of each pinch valve is deemed to read on the claimed stop cock motor and stopcock pin, respectively).
Regarding claim 10, Griffin teaches the apparatus of claim 1 further comprising: a hangar assembly for supporting one or more cell processing bags (T-shaped hanger assembly 924 that extends from the base 910 and includes a plurality of hooks 926 for suspending a plurality of processing and/or source vessels or bags – paragraph 248 and Fig. 78).
Regarding claim 12, Griffin teaches the apparatus of claim 1 further comprising: a manual mechanism (a back plate of the magnetic field generator 962 – Fig. 78) configured to selectively move the magnetic field generator into or out of engagement with the magnetic cell isolation holder in the event of a power loss (the back plate can be used to pull the magnetic field generator 962 in and out of engagement with the magnetic cell isolation holder 960 – Fig. 78).
Regarding claim 13, Griffin teaches the apparatus of claim 1 further comprising: an air bubble sensor located on the base (one of the sensor 920 may be a bubble detector or an optical detector – paragraph 271).
Regarding claim 15, Griffin teaches the apparatus of claim 1 further comprising: an air inlet filter located on the base (a top port 1118 having a filter so that sterile air may be introduced into the system – paragraph 268 and Fig. 78).
Regarding claim 16, Griffin teaches the apparatus of claim 1 further comprising: a data communications port (The apparatus 900 may be under control of a controller (e.g., controller 110), operating according to instructions executed by a processor and stored in memory – paragraph 249).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Ladtkow in view of Griffin.
Regarding claim 4, Ladtkow teaches the apparatus of claim 1.
However, Ladtkow does not teach an electric motor located within the base and configured to selectively bring the magnetic field generator in operative contact with the magnetic cell isolation holder.
Griffin teaches an electric motor located within the base (the bed plate 746 includes an actuator mechanism 761 (e.g., a motor) to lift the attached bioreactor – Figs. 28 and 41) and configured to selectively bring the magnetic field generator in operative contact with the magnetic cell isolation holder (the motor is capable of bringing a magnet in contact with a magnetic cell isolation holder – Fig. 41). Griffin teaches to use the actuator mechanism 761 to tilt the bioreactor vessel atop the bed plate to provide for agitation and/or to assist draining of the bioreactor vessel (paragraph 176).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the flowcell 800, as taught by Ladtkow, with the actuator mechanism 761, taught by Griffin, to provide for agitation and/or to assist draining of the flow cells 800. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Ladtkow and Griffin teach devices for magnetic cell separation.
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Griffin.
Regarding claim 7, Griffin teaches the apparatus of claim 1.
However, Griffin does not teach a locking mechanism on the base to secure a removable cell processing kit to the apparatus.
Griffin teaches another embodiment (Figs. 34, 37) a locking mechanism on the base to secure a removable cell processing kit to the apparatus (a solenoid array 736 for clamping’s tubing pinch valve anvil 744 capable of secure a kit 600 – Fig. 37-38). Griffin teaches a controller that operates the solenoid array 736 as automated pinch valves so that processing can be substantially automated (paragraph 112 and 133).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device, as taught by Griffin (Fig. 78), with the solenoid array and controller 210, to automate the controls and pinch valves. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Griffin teaches different embodiments of the same invention.
Regarding claim 8, Griffin, modified by Griffin, teaches the apparatus of claim 7 wherein the locking mechanism comprises at least one fixation clamp (a solenoid array 736 for clamping’s tubing pinch valve anvil 744 capable of secure a kit 600 – Fig. 37-38).
Regarding claim 9, Griffin, modified by Griffin, teaches the apparatus of claim 7 wherein the locking mechanism provides automated locking (the controller 210 is configured to provide substantially automated control – paragraph 112).
Claims 11 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Griffin in view of Handique et al (US20140272965A1 published 09/18/2014; hereinafter Handique)
Regarding claim 11, Griffin teaches the apparatus of claim 1.
However, Griffin does not teach a cooling fan located within the base.
Handique teaches a cell capture device comprising a cooling fan located within the base (a fan blower coupled to the plate 173 to provide forced air cooling as necessary – paragraph 58). Handique further teaches to use a temperature control module 171 or any other suitable element configured to facilitate temperature control with a resolution of 1˚C.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the base, as taught by Griffin, with the fan blower and temperature control module, taught by Handique, to facilitate temperature control with a resolution of 1˚C. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Griffin and Handique teach cell capture and purification systems.
Regarding claim 14, Griffin teaches the apparatus of claim 1.
However, Griffin does not teach a line pressure sensor located on the base.
Handique teaches a cell capture device comprising a line pressure sensor located on the base (pump 160 can also comprise a pressure sensor 161, which functions to enable measurement of a pressure provided by the pump 160 – Fig. 1B and paragraph 50).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device, as taught by Griffin, with the pump, pressure sensor, and controller, taught by Handique, to enable measurement of a pressure provided by the pump. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Griffin and Handique teach cell capture and purification systems.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TINGCHEN SHI whose telephone number is (571)272-2538. The examiner can normally be reached M-F 9am-6pm.
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/T.C.S./Examiner, Art Unit 1796
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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