DETAILED ACTION
Preliminary Amendment filed on 04/22/2024 is acknowledged. Claims 3, 5,8-9, 21-23 and 28-37 are cancelled. Claims 1-2, 4, 6-7, 10-2024-27 and 38 are pending in the application and are considered on merits.
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 .
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.
Claim(s) 1-2, 4, 6-7, 10-12, 14-18, 20, 24-27 and 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Garlinghaus et al (US 2021/0283565, IDS) (Garlinghaus).
Regarding claim 1, Garlinghaus discloses an automated system for cell processing (abstract), comprising:
a cartridge (par [0008]) comprising
a plurality of cartridge modules including
a bioreactor module, a counterflow centrifugal elutriation module, and at least one of an electroporation module, a magnetic-activated cell selection module, a fluorescence-activated cell selection module (FACS), or a spinoculation module (par [0008]),
at least one sterile liquid transfer port (par [0009]), and
a liquid transfer bus fluidically coupled to each cartridge module (par [0009]); and
a plurality of docking station modules (instruments) corresponding to the plurality of cartridge modules (par [0006]), each of the plurality of docking station modules being independently configured to perform one or more cell processing operations upon the cartridge in coordination with a respective cartridge module (par [0006][0010] [0011]).
Gerlinghaus does not expressly disclose that all of the corresponding instruments/interfaces are arranged together as one docking station having a plurality of docking station modules and being sized and shaped to receive a single cartridge, as claimed. However, it would have been obvious to one of ordinary skill in the art to arrange Gerlinghaus’s corresponding instrument interfaces as modules of a single docking station configured to receive one cartridge. Gerlinghaus already teaches the same cartridge modules, corresponding processing instruments, and cartridge/instrument coordination. Consolidating the corresponding interfaces into a single docking station would have predictably reduced or eliminated robotic movement of the cartridge between separate instruments, simplified automated control, reduced system footprint, and reduced opportunities for contamination or handling error while performing the same known cell-processing operations on the same cartridge modules.
Regarding claim 2, Garlinghaus discloses that wherein the liquid transfer bus is fluidically coupled to each cartridge module by fluid conduits arranged between ports on the liquid transfer bus and respective ports of each cartridge module (par [0009]).
Regarding claim 4, Garlinghaus discloses that the system of claim 1, further comprising a sterile liquid transfer device configured to facilitate transfer of liquid between the cartridge and a closed volume fluid device (par [0009]).
Regarding claim 6, Garlinghaus discloses that wherein the sterile liquid transfer device comprises at least one actuator (pump) (par [0009]).
Regarding claim 7, Garlinghaus discloses that wherein the actuator actuates one of the at least one sterile liquid transfer port of the cartridge and a corresponding sterile liquid transfer port of a closed volume fluid device (par [0231]).
Regarding claim 10, Garlinghaus discloses that wherein the plurality of cartridge modules comprises the electroporation module (par [0008]).
Regarding claim 11, Garlinghaus discloses that wherein the plurality of cartridge modules comprises the magnetic-activated cell selection module (par [0008]).
Regarding claim 12, Garlinghaus discloses that wherein the plurality of cartridge modules comprises the fluorescence-activated cell selection module (FACS) (par [0008]).
Regarding claim 14, Garlinghaus discloses that wherein the plurality of docking station modules comprises a corresponding bioreactor module (par [0008]).
Regarding claim 15, Garlinghaus discloses that wherein the plurality of docking station modules comprises a corresponding magnetic-activated cell selection module (par [0008]).
Regarding claim 16, Garlinghaus discloses that wherein the plurality of docking station modules comprises a corresponding fluorescence-activated cell selection module (fluorescence-activated cell sortimg instrument) (par [0011]).
Regarding claim 17, Garlinghaus discloses that wherein the plurality of docking station modules comprises a corresponding electroporation module (electroporation instrument) (par [0011]).
Regarding claim 18, Garlinghaus discloses that wherein the plurality of docking station modules comprises a corresponding counterflow centrifugal elutriation module (counterflow centrifugal elutriation instrument) (par [0011]).
Regarding claim 20, Garlinghaus discloses that wherein the cartridge comprises a pump fluidically coupled to the liquid transfer bus (par [0009]).
Regarding claim 24, Garlinghaus teaches an automated cell processing method (abstract) comprising:
performing at least two cell processing operations within a cartridge positioned in a docking station model (an instrument) (par [0008]), wherein the cartridge comprises a plurality of cartridge modules (par [0008]), at least one sterile liquid transfer port, and a liquid transfer bus fluidically coupled to each cartridge module (par [0009]), and a plurality of docking station modules (instruments) corresponding to the plurality of cartridge modules (par [0007][0010][0011]),
wherein the plurality of cartridge modules comprises a bioreactor module, a counterflow centrifugal elutriation module, and at least one of an electroporation module, a magnetic-activated cell selection module, a fluorescence-activated cell selection module, or a spinoculation module (par [0008]), and
wherein the cell processing operations are automatic upon execution of a set of received instructions (par [0040]).
Again, Gerlinghaus does not expressly disclose that all of the corresponding instruments/interfaces are arranged together as one docking station having a plurality of docking station modules and being sized and shaped to receive a single cartridge, as claimed. However, it would have been obvious to one of ordinary skill in the art to arrange Gerlinghaus’s corresponding instrument interfaces as modules of a single docking station configured to receive one cartridge. Gerlinghaus already teaches the same cartridge modules, corresponding processing instruments, and cartridge/instrument coordination. Consolidating the corresponding interfaces into a single docking station would have predictably reduced or eliminated robotic movement of the cartridge between separate instruments, simplified automated control, reduced system footprint, and reduced opportunities for contamination or handling error while performing the same known cell-processing operations on the same cartridge modules.
Regarding claim 25, Garlinghaus teaches that the method of claim 24, further comprising:
actuating one of the at least one sterile liquid transfer port of the cartridge and a corresponding sterile liquid transfer port of a closed volume fluid device to facilitate transfer of liquid therebetween (par [0009]).
Regarding claim 26, Garlinghaus teaches that wherein facilitating the transfer of liquid between the cartridge and the closed volume fluid device comprises actuating the one of the at least one sterile liquid transfer port and the corresponding sterile liquid transfer port (par [0009]).
Regarding claim 27, Garlinghaus teaches that wherein the transfer of liquid between the cartridge and the closed volume fluid device comprises extraction of at least a portion of a cell processing sample from the cartridge (par [0269]).
Regarding claim 38, Garlinghaus teaches that wherein the two or more cell processing performed within the cartridge are performed upon cells within the cartridge (par [0008]).
Claim(s) 13 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Garlinghaus et al (US 2021/0283565, IDS) (Garlinghaus) in view of Remley et al (Journal of Translational Medicine, 2021) (Remley).
Regarding claim 13, Garlinghaus does not specifically disclose that wherein the plurality of cartridge modules comprises the spinoculation module.
However, Remley teaches automated closed-system spinoculation for cell therapy gene transfer. Remley explains that lentiviral vectors are effectively transferred into lymphocytes or hematopoietic progenitor cells using spinoculation (abstract), and describes an automated closed-system spinoculation method to reduce technician hands-on time and reduce the likelihood of microbial contamination (abstract). Remley further teaches that the Sepax system uses high-speed centrifugation in a closed chamber to transduce T-cells, and that the protocol allows adjustment of volume, cell concentration, spin duration, and g-force (page 2, par 4).
It would have been obvious to one of ordinary skill in the art to modify Gerlinghaus’s cartridge-based automated cell-processing system to include a spinoculation module, as taught by Remley, because Gerlinghaus already teaches a modular cartridge system for automated cell therapy manufacturing, including gene-transfer-related processing such as electroporation/transduction, and Remley teaches that automated closed-system spinoculation was a known cell-processing technique for improving gene transfer while reducing hands-on time and contamination risk. The modification would have involved incorporating a known spinoculation cell-processing function into Gerlinghaus’s modular automated cartridge platform to obtain the predictable benefit of automated, closed-system viral gene transfer.
Regarding claim 19, Garlinghaus-Remley fairly suggest that wherein the plurality of docking station modules comprises a corresponding spinoculation module.
Gerlinghaus teaches the system of claim 1 as discussed above. Gerlinghaus teaches an automated cell-processing system having a plurality of instruments independently configured to perform one or more cell-processing operations upon a cartridge (par [0007]), and further teaches that the instruments interface with the cartridge to perform cell-processing operations (par [0007]). Gerlinghaus also teaches corresponding processing instruments/modules, including bioreactor, MACS, FACS, electroporation, and CCE instruments/modules (par [0010][0011]).
Gerlinghaus does not expressly teach that the plurality of docking station modules comprises a corresponding spinoculation module.
Remley teaches automated closed-system spinoculation for cell therapy gene transfer (abstract). Remley compares Sepax spinoculation, bag spinoculation, and static bag transduction, and teaches that Sepax spinoculation is an automated closed-system process for lentiviral gene transfer (abstract). Remley further teaches that the Sepax system uses high-speed centrifugation in a closed chamber to transduce T-cells, and that the protocol allows adjustment of volume, cell concentration, spin duration, and g-force (page 2, par 4).
It would have been obvious to one of ordinary skill in the art to modify Gerlinghaus’s docking-station/module arrangement to include a corresponding spinoculation module, as taught by Remley, because Gerlinghaus already teaches a modular automated cell-processing platform in which corresponding instruments/modules perform cell-processing operations on cartridge modules. Remley teaches that automated closed-system spinoculation was a known cell-processing operation for gene transfer, and that it reduced hands-on time and contamination risk. Incorporating Remley’s automated spinoculation function as one of Gerlinghaus’s corresponding processing modules would have predictably expanded Gerlinghaus’s modular cell-processing system to perform a known automated gene-transfer operation while maintaining closed-system automated processing.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to XIAOYUN R XU, Ph. D. whose telephone number is (571)270-5560. The examiner can normally be reached M-F 8am-5pm.
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/XIAOYUN R XU, Ph.D./ Primary Examiner, Art Unit 1797
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