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 .
Status of Claims
Claims 1-14 are pending and examined below.
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.
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.
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 1-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20130210130 A1 (“Larcher”).
As per Claim 1, Larcher discloses a cell production system, comprising:
a robot configured to assist in cell production (¶ 7—“automated cell culture arrangement”; Abstract—“at least one additional tool module, which is configured or configurable to act upon or to monitor the contents of a bioreactor and is movable relative to the at least one closed cell culture module or it is movable relative to one or several components of the at least one closed cell culture module”);
a plurality of cell production devices, which includes a closed culture vessel and which is affected by the robot in a one-to-many manner (¶ 19—"the at least one closed cell culture module comprises a manifold, interconnecting tubing and a plurality of valves connecting a plurality of vessels, forming a closed system”; ¶ 11—“allows a tool module to act upon or to monitor several bioreactors or their contents of the at least one closed cell culture module”; ¶ 17—“shared and automatic use of movable tools, such as microscopes, sensors, centrifuges etc., which without disrupting the closed system of the closed cell culture module act upon or monitor different bioreactors”); and
a wall structure in which the plurality of cell production devices is disposed spatially separating a hazardous area side in which the robot operates and a safe area side opposite to the hazardous area side (¶ 20—“comprises at least two units, a cell maintenance unit…and a processing unit (or cell processing unit) for cell growth and cell processing”; ¶ 23—“cell processing unit and the cell maintenance unit are separated by an insulating separation wall element”), wherein
each of the plurality of cell production devices comprises a double-sided structure with the hazardous area side and the safe area side (¶ 11—“The relative movement of the at least one closed cell culture module with respect to at least one tool module of the automated cell culture arrangement is possible without opening the at least one closed cell culture module or disconnecting it from the arrangement”), and
each of the plurality of cell production devices is configured to be maintained from the safe area side regardless of a state of operation of the robot (¶ 27—“The cell processing rack, which preferably fits into the cell processing unit of the housing is removable from the housing for easier installation of the cell culture module, for cleaning and service purposes”).
As per Claim 2, Larcher further discloses wherein each of the plurality of cell production devices further comprises a removable cell production cartridge facing the hazardous area side (¶ 19—“individual vessels of the closed cell culture system are preferably movable both with respect to one another and with respect to various tools for manipulation, observation, thermal treatment, irradiation etc. while the system remains closed”), and
a driving base facing the safe area side and configured to drive the removable cell production cartridge (¶ 12—“tool modules include manipulator tool modules such as, shakers, peristaltic pumps, actuators for opening and closing valves, actuators or moving mechanisms for displacing modules or other components of the closed cell culture module and/or the tool modules relative to each other”).
As per Claim 3, Larcher further discloses wherein the removable cell production cartridge is disposable (¶ 19—“the at least one closed cell culture module comprises a manifold, interconnecting tubing and a plurality of valves connecting a plurality of vessels, forming a closed system”), and
the driving base is reusable (¶ 27—“The cell processing rack, which preferably fits into the cell processing unit of the housing is removable from the housing for easier installation of the cell culture module, for cleaning and service purposes”).
As per Claim 4, Larcher further discloses wherein a removable cell production cartridge has a window allowing observation of a cell production step by a sensor from the hazardous area side (¶ 12—“monitoring tool modules for monitoring the process and the cell cultures in the bioreactors, such monitoring modules being, a cell imaging device (e.g. comprising a microscope and a camera)”).
As per Claim 5, Larcher further discloses:
an airflow control system in a space on the hazardous area side, wherein the airflow control system comprises a filtration filter on a discharge side of the wall structure (¶ 20—“In each unit the ambient physical conditions are adjustable individually such as for example temperature and humidity”; ¶ 24—“Preferred embodiments of the housing are designed leak tight and made of appropriate material such that they can be sterilized with hydrogen peroxide vapor”), and
an exhaust fan configured to discharge clean air provided by the filtration filter to an outside of the wall structure (¶ 23—“the openings or channels connecting the processing with the maintenance units comprise insulating material such as foamed polystyrene, through which the tubings are lead”), and
the airflow control system is configured to control downflow of air flowing from above to below the wall structure, orcontrol upflow of air flowing from below to above the wall structure (¶ 23—“the openings or channels connecting the processing with the maintenance units comprise insulating material such as foamed polystyrene, through which the tubings are lead”).
As per Claim 6, Larcher further discloses wherein
the plurality of cell production devices is configured to be removed to the safe area side (¶ 27—“The cell processing rack, which preferably fits into the cell processing unit of the housing is removable from the housing for easier installation of the cell culture module, for cleaning and service purposes”).
As per Claim 7, Larcher further discloses wherein the wall structure comprises
an opening to place a corresponding cell production device of the plurality of cell production devices (¶ 23—“the openings or channels connecting the processing with the maintenance units comprise insulating material such as foamed polystyrene, through which the tubings are lead”), and
a shutter configured to move between an open position and a closed position (¶ 23—“the collection of tubings one or more openings or channels for collections of tubings are preferably positioned at an easily accessible location”), and
when the corresponding cell production device is inserted into the opening, the shutter is configured to move to the open position by a forward movement of the corresponding cell production device and the corresponding cell production device closes the opening (¶ 11—“relative movement of the at least one closed cell culture module with respect to at least one tool module of the automated cell culture arrangement is possible without opening the at least one closed cell culture module”), and
when the corresponding cell production device is removed out from the opening, the shutter is configured to move to the closed position due to a retraction of the corresponding cell production device and close the opening (¶ 27—“The cell processing rack, which preferably fits into the cell processing unit of the housing is removable from the housing”).
As per Claim 8, Larcher further discloses wherein
the wall structure is a cell surrounding a robot (¶ 20—“the automated cell culture arrangement comprises at least two units, a cell maintenance unit…and a processing unit”).
As per Claim 9, Larcher further discloses wherein the wall structure is parallel to a line on which the robot is self-propelled (¶ 34—“stacking of multiple cell maintenance racks and/or cell processing racks”).
As per Claim 10, Larcher further discloses:
a shuttle configured to transport the plurality of cell production devices between a stationing location of the robot and storage locations of the plurality of cell production devices (¶ 34—“a movable carrier such as an elevator”; ¶ 92—“transports the cell imaging device 1104 and the cell wash/concentration device 1105 to each cell processing unit level”), wherein
the wall structure is provided at the stationing location of the robot or at the storage locations of the plurality of cell production devices (¶ 27—“The cell processing rack, which preferably fits into the cell processing unit of the housing”; ¶ 34—“stacking of multiple cell maintenance racks and/or cell processing racks”).
As per Claim 11, Larcher further discloses wherein
the driving base comprises
a driving unit (¶ 12—“peristaltic pumps, actuators for opening and closing valves, actuators or moving mechanisms for displacing modules or other components”), and
an outside air blocking member covering the driving unit (¶ 24—“the housing are designed leak tight and made of appropriate material such that they can be sterilized”), and
the cell production system is configured to be maintained by removing the outside air blocking member (¶ 27—“The cell processing rack, which preferably fits into the cell processing unit of the housing is removable from the housing for easier installation of the cell culture module, for cleaning and service purposes”).
As per Claim 12, Larcher further discloses wherein
the robot comprises a first sensor near an end-effector (¶ 12—“monitoring tool modules for monitoring the process and the cell cultures in the bioreactors, such monitoring modules being, a cell imaging device (e.g. comprising a microscope and a camera), or any kind of sensor technology device such as a pH and temperatures sensors”), and
the first sensor is configured to carry out at least one of a confirmation of a state of the driving base, a correction of target position and posture for mounting of the removable cell production cartridge onto the driving base, a confirmation of true or false of a content that is housed in a fluid feeder, a correction of a target position and a posture for mounting of the fluid feeder on the removable cell production cartridge, a confirmation of fluid level change in at least one of the fluid feeder or the removable cell production cartridge, a confirmation of separation of a source cell to be induced, a confirmation of mixture of an inducing factor, a color tone analysis of culture medium pH, or a confirmation of a state of the removable cell production cartridge (¶ 12—“monitoring tool modules for monitoring the process and the cell cultures in the bioreactors, such monitoring modules being, a cell imaging device (e.g. comprising a microscope and a camera), or any kind of sensor technology device such as a pH and temperatures sensors”).
As per Claim 13, Larcher further discloses wherein
the robot is configured to carry a second sensor that is a camera or an ultrasonic sensor comprising high-magnification lens, to the removable cell production cartridge (¶ 12—“a cell imaging device (e.g. comprising a microscope and a camera)”), and
cells or cell mass in the removable cell production cartridge are measured using the second sensor (¶ 18—“can monitor cell growth in a large number of bioreactors”).
As per Claim 14, Larcher further discloses wherein the robot is configured to carry out at least one of mounting and unmounting of the removable cell production cartridge onto the driving base, or mounting of a fluid feeder to the removable cell production cartridge (¶ 12—"actuators or moving mechanisms for displacing modules or other components of the closed cell culture module and/or the tool modules relative to each other”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BASIL T JOS whose telephone number is (571)270-5915. The examiner can normally be reached 11:00 - 8:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, THOMAS WORDEN can be reached at (571) 272-4876. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Basil T. Jos/Primary Examiner, Art Unit 3658
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