DETAILED ACTION
Request for reconsideration of the application filed on 09/17/2026, is acknowledged. No amendment was made to the claims. Claims 1-2, 4, 6-7, 10-20, 24-27 and 38 are pending in the application and are considered on merits.
In response to reconsideration, the examiner maintains rejections over prior art established in the previous Office 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 .
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Gerlinghaus is not limited to only one fixed distributed-instrument configuration. Gerlinghaus teaches that “the same consumable cartridge can be received by different instruments” and that “[t]he system 500 may comprise a modular design to accommodate different instrument configurations.” (par [0257]). Gerlinghaus also teaches that cartridges include “one or more modules configured to interface with an instrument or instruments,” (par [0258]), and that the robot may move “a cartridge and/or instrument” to perform one or more processing steps (par [0258]). Therefore, Gerlinghaus itself supports reconfiguring the arrangement of the corresponding instrument interfaces.
Further, consolidating known corresponding processing interfaces into a single docking station would have been an obvious engineering design choice. The claimed docking station does not require a new cell-processing operation beyond the same known processing interfaces already taught by Gerlinghaus. Rather, the distinction concerns whether those known corresponding interfaces are distributed among separate instruments or arranged together in one docking station. MPEP § 2144.04(V)(B) recognizes, citing In re Larson, that using a one-piece construction instead of several parts rigidly secured together can be a matter of obvious engineering choice when the structures perform the same known function. Here, arranging Gerlinghaus’s known corresponding bioreactor, MACS, FACS, electroporation, CCE, and sterile-transfer interfaces together as docking station modules would have predictably performed the same cell-processing functions on the corresponding cartridge modules.
Gerlinghaus’s disclosure of throughput and parallel-processing benefits for a distributed embodiment does not criticize, discredit, or discourage a single-cartridge configuration. Gerlinghaus teaches that “a plurality of cell processing steps may be performed within a single cartridge,” (par [0213]), and further teaches that the cartridge may include the claimed types of cell-processing modules. Gerlinghaus also teaches that the cartridge may be a “self-contained device capable of performing one or more cell processing steps,” with modules integrated into a fixed configuration or configurable/moveable within the cartridge (par [0259]).
A skilled artisan would have recognized the claimed arrangement as a predictable tradeoff: Gerlinghaus’s distributed configuration may provide higher parallel throughput, while a single docking station receiving a single cartridge would reduce the need to move the cartridge among separate instruments, reduce docking/undocking events, simplify control for single-cartridge processing, and provide a compact integrated arrangement. Choosing a lower-throughput but more integrated configuration does not render the modification nonobvious, particularly where Gerlinghaus already teaches modular cartridge/instrument interfaces and different instrument configurations.
Gerlinghaus teaches a workcell containing the corresponding instruments in a common interior zone and a robot configured to move cartridges “from any instrument to any other instrument or reagent vault.” (par [0249]). Gerlinghaus further teaches that the cartridge is closed and can move through a non-sterile field without contamination, and may undergo automated decontamination (par [0251]). Thus, Gerlinghaus provides the reason to reduce transfer complexity and preserve sterile automated processing. Consolidating the known corresponding interfaces into a single docking station for receiving a single cartridge would have been a predictable implementation of Gerlinghaus’s modular cartridge and corresponding instrument-interface teachings.
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.
Response to Arguments
Applicant's arguments filed 09/17/2026 have been fully considered but they are not persuasive.
Applicant argues that Gerlinghaus fails to teach or suggest the claimed “single docking station comprising a plurality of docking station modules corresponding to the plurality of cartridge modules and sized and shaped to receive a single cartridge.” Applicant further argues that, in Gerlinghaus, “each instrument corresponds to a single cartridge module, and the cartridge is moved among a plurality of such separate instruments,” which Applicant characterizes as the “structural inverse” of the claimed docking station. (remark, page 7).
Examiner respectfully disagrees. Claim 1 recites “a docking station comprising a plurality of docking station modules corresponding to the plurality of cartridge modules,” but claim 1 does not recite that the plurality of docking station modules must engage the cartridge simultaneously, nor does claim 1 recite that the cartridge must remain stationary during all cell-processing operations.
Gerlinghaus teaches the same general cartridge-side structure, including a cartridge having a plurality of modules such as a bioreactor, CCE module, magnetic-activated cell selection module, electroporation module, and FACS module, as well as a sterile liquid transfer port and a liquid transfer bus fluidically coupled to each module. Gerlinghaus further teaches corresponding workcell instruments including a bioreactor instrument, MACS/cell-selection instrument, FACS/cell-sorting instrument, electroporation instrument, CCE instrument, and sterile liquid transfer instrument. Thus, Gerlinghaus teaches the claimed cartridge modules and corresponding processing interfaces/instruments, and the difference is the physical arrangement of those corresponding interfaces.
Applicant further argues that a skilled artisan would not have been motivated to modify Gerlinghaus because Gerlinghaus uses separate instruments and moves cartridges between instruments to improve efficiency, throughput, flexibility, and parallel processing (remark, page 7). Applicant also argues that consolidating Gerlinghaus’s corresponding interfaces into one docking station would undermine Gerlinghaus’s distributed, shared-instrument configuration (remark, page 8).
Examiner respectfully disagrees. Gerlinghaus is not limited to only one fixed distributed-instrument configuration. Gerlinghaus teaches that “the same consumable cartridge can be received by different instruments” and that “[t]he system 500 may comprise a modular design to accommodate different instrument configurations.” (par [0257]). Gerlinghaus also teaches that cartridges include “one or more modules configured to interface with an instrument or instruments,” (par [0258]), and that the robot may move “a cartridge and/or instrument” to perform one or more processing steps (par [0258]). Therefore, Gerlinghaus itself supports reconfiguring the arrangement of the corresponding instrument interfaces.
Further, consolidating known corresponding processing interfaces into a single docking station would have been an obvious engineering design choice. The claimed docking station does not require a new cell-processing operation beyond the same known processing interfaces already taught by Gerlinghaus. Rather, the distinction concerns whether those known corresponding interfaces are distributed among separate instruments or arranged together in one docking station. MPEP § 2144.04(V)(B) recognizes, citing In re Larson, that using a one-piece construction instead of several parts rigidly secured together can be a matter of obvious engineering choice when the structures perform the same known function. Here, arranging Gerlinghaus’s known corresponding bioreactor, MACS, FACS, electroporation, CCE, and sterile-transfer interfaces together as docking station modules would have predictably performed the same cell-processing functions on the corresponding cartridge modules.
Applicant’s teaching-away argument is not persuasive. Gerlinghaus’s disclosure of throughput and parallel-processing benefits for a distributed embodiment does not criticize, discredit, or discourage a single-cartridge configuration. Gerlinghaus teaches that “a plurality of cell processing steps may be performed within a single cartridge,” (par [0213]), and further teaches that the cartridge may include the claimed types of cell-processing modules. Gerlinghaus also teaches that the cartridge may be a “self-contained device capable of performing one or more cell processing steps,” with modules integrated into a fixed configuration or configurable/moveable within the cartridge (par [0259]).
A skilled artisan would have recognized the claimed arrangement as a predictable tradeoff: Gerlinghaus’s distributed configuration may provide higher parallel throughput, while a single docking station receiving a single cartridge would reduce the need to move the cartridge among separate instruments, reduce docking/undocking events, simplify control for single-cartridge processing, and provide a compact integrated arrangement. Choosing a lower-throughput but more integrated configuration does not render the modification nonobvious, particularly where Gerlinghaus already teaches modular cartridge/instrument interfaces and different instrument configurations.
Applicant further argues that the Office’s rationale is hindsight because Gerlinghaus already describes a compact workcell and reduced contamination through closed cartridges and sterile fluid transfer (remark, page 8).
Examiner respectfully disagrees. The rationale is based on Gerlinghaus’s own teachings, not Applicant’s disclosure. Gerlinghaus teaches a workcell containing the corresponding instruments in a common interior zone and a robot configured to move cartridges “from any instrument to any other instrument or reagent vault.” (par [0249]). Gerlinghaus further teaches that the cartridge is closed and can move through a non-sterile field without contamination, and may undergo automated decontamination (par [0251]). Thus, Gerlinghaus provides the reason to reduce transfer complexity and preserve sterile automated processing. Consolidating the known corresponding interfaces into a single docking station for receiving a single cartridge would have been a predictable implementation of Gerlinghaus’s modular cartridge and corresponding instrument-interface teachings.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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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