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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/7/2026 has been entered.
Response to Amendment
The amendment filed January 7, 2026 has been entered.
Claims 1-2, 4-18, 20, 33-38, and 40-41 remain pending and examined in the application. Claims 3, 19, 21-32, and 39 are canceled.
Based on Applicant’s amendments and remarks, the previous prior art rejection has been modified to address the claim amendments.
Information Disclosure Statement
The information disclosure statement (IDS) received on 1/7/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 33 is objected to because of the following informalities:
Regarding claim 33, the claim recites, “wherein the axle coupled to a motor, and…”, which is grammatically incorrect. The above limitation needs to be amended to recite, “wherein the axle is coupled to a motor, and…” to be grammatically correct.
Appropriate correction is required.
Claim Interpretation
The limitation “a refrigeration unit” in at least claim 1 has been examined as any region of space or device capable of both storing and cooling reagents.
In claim 6, the limitation “wherein the refrigeration unit is one of a plurality of refrigeration units of the reagent vault system” has been interpreted as requiring that a plurality of refrigeration units are present in the reagent vault system.
The limitation “a waste unit” in claim 12 has been examined as a region of space or device capable of storing waste.
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.
Claims 1-2, 5-7, 10-11, 13-14, 20, 34-35, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Katsumi et al. (US Pub. No. 2011/0223064; hereinafter Katsumi; already of record) in view of Hamel et al. (US Pub. No. 2003/0031542; hereinafter Hamel; already of record), Higo et al. (US Pat. No. 4,751,184; hereinafter Higo; already of record), and Blanchard (US Pub. No. 2022/0259546; already of record)
Regarding claim 1, Katsumi discloses a reagent vault system for use in cell processing ([0060], see Fig. 6 at reagent storage 40). The system comprises:
a refrigeration unit configured to store one or more cell processing reagents ([0035]-[0036], [0060]-[0061], [0074], see Figs. 2, 6 at coolers 80, and reagent container racks 310, 320. The reagent container racks, in combination with the coolers, act as refrigeration units, as described in the Claim Interpretation section of this instant Office action. Each set of racks associated with one of the coolers can be considered a refrigeration unit under broadest reasonable interpretation. See MPEP 2111).
A rotating carousel within the refrigeration unit configured to receive a fluid device, wherein the fluid device is configured to store the one or more cell processing reagents ([0035]-[0036], see Fig. 6 at first reagent table 21 and second reagent table 22, which can be rotation driven independently. The tables are capable of receiving multiple fluid devices (e.g. reagent containers 300). Further, the one or more fluid devices are not positively recited).
A scanner system comprising a scanner [0041], see Fig. 6 at reagent barcode reader 33).
Katsumi fails to explicitly disclose:
the refrigeration unit comprises a door;
the rotating carousel comprises a radially arranged plurality of discrete columns, each column comprising a plurality of vertically stacked slots, wherein each slot is configured to receive the fluid device;
the scanner system is within the refrigeration unit and comprises:
a rail coupled to a sidewall of the refrigeration unit and extending in a direction along an axle of the rotating carousel and having a length about equal to a length of the axle; and
a scanner movable along the rail and configured to scan a fluid device received in each slot;
a sensor configured to measure a decontaminant concentration within the refrigeration unit; and
a controller configured to prevent opening of the door when the measured decontaminant concentration is above a threshold.
Hamel is in the analogous field of storage of materials used in reagent dispensing (Hamel; [0001], [0054]-[0060], see Figs. 1-3 at carousel 202 including stackers 222 in compartments 222, where magazines 300 can be loaded into stackers 222 via rails 230 so that magazines 300 are vertically stacked in the stackers 222. The magazines hold pipette tips 310). Hamel teaches a rotating carousel comprising a radially arranged plurality of discrete columns, each column comprising a plurality of vertically stacked slots, each slot configured to receive a fluid device (Hamel; [0054]-[0060], see Figs. 1-3 at carousel 202 including stackers 222 in compartments 222, where magazines 300 can be loaded into stackers 222 via rails 230 so that magazines 300 are vertically stacked in the stackers 222). A scanner system within a unit and comprising a rail coupled to a sidewall of the unit and extending in a direction along an axle of a rotating carousel, and a scanner movable along the rail and configured to scan a fluid device received in each slot (Hamel; [0050], [0054], [0068], see Figs. 3-4, 9A-9J, especially at sensor on upper gripper head 26, where gripper moves up and down on vertical rails 109, and Fig. 3 at axle 218 for carousel 202). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of Katsumi with the teachings of Hamel so that the rotating carousel comprises a radially arranged plurality of discrete columns, each column comprising a plurality of vertically stacked slots, where each slot is configured to receive a fluid device. The motivation would have been to provide a carousel having a configuration where the carousel can easily be rotated so that a desired fluid device can be retrieved from inside the carousel for use (Hamel; [0054]-[0060], see Figs. 1-3). Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to choose the claimed carousel configuration, as taught by Hamel, from a finite number of identified, predictable ways to store components within a rotating carousel. The motivation would have been to allow an operator or gripping device to access all slots within a column at once, which would be beneficial if reagents for similar uses are grouped into a common column. Further, It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Katsumi with the teachings of Hamel so that the scanner system is within the refrigeration unit and comprises a rail coupled to a sidewall of the refrigeration unit and extending in a direction along an axle of the rotating carousel, and a scanner movable along the rail and configured to scan a fluid device received in each slot. The motivation would have been to be able to retrieve a new, unused fluid device from a slot in the carousel as desired (Hamel; [0050], [0068], see Figs. 3-4, 9A-9J).
Modified Katsumi fails to explicitly disclose:
the refrigeration unit comprises a door;
the rail has a length about equal to a length of the axle;
a sensor configured to measure a decontaminant concentration within the refrigeration unit; and
a controller configured to prevent opening of the door when the measured decontaminant concentration is above a threshold.
Higo is in the analogous field of automatic analyzers (Higo Col. 1 Lns. 7-12). Higo teaches a rail that has a length approximately equal to the length of a processing area (Higo; Col. 4 Lns. 11-23, Col. 5 Lns. 7-17, see Fig. 1 at rail 46b on which movable scanning body 47 travels, where the rail is approximately the same length as test pack trays 41). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of modified Katsumi with the teachings of Higo so that the rail has a length about equal a length of the axle, so that the scanner can scan each fluid device within the system for retrieval, while also minimizing the size of the system, thereby conserving space.
Modified Katsumi fails to explicitly disclose:
the refrigeration unit comprises a door;
a sensor configured to measure a decontaminant concentration within the refrigeration unit; and
a controller configured to prevent opening of the door when the measured decontaminant concentration is above a threshold.
Blanchard is in the analogous field of cell culture incubators (Blanchard [0005]) and teaches a unit that comprises a door (Blanchard; [0076]-[0081], see Fig. 1 at cell culture incubator 10 having an external door 12 and an internal door 14). A sensor is configured to measure a decontaminant concentration within the unit (Blanchard [0045]). A controller is configured to prevent opening of the door when the measured decontaminant concentration is above a threshold (Blanchard; [0045], [0063]). The controller is a hydrogen peroxide sensor (Blanchard [0045]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of modified Katsumi with the teachings of Blanchard so that the refrigeration unit comprises a door, a sensor configured to measure a decontaminant concentration within the refrigeration unit, and a controller configured to prevent opening of the door when the measured decontaminant concentration is above a threshold, where the controller is a hydrogen peroxide sensor. The motivation would have been to be able to decontaminate items passing into the internal chamber of the refrigeration unit using a transfer chamber, while also ensuring that the decontaminant used in the decontamination operation does not enter the internal chamber, thereby preventing decontamination and reducing undesirable condition fluctuations in the internal chamber (Blanchard; [0045], [0021]-[0022]). Further, hydrogen peroxide can be used as a sterilizing gas (Blanchard [0005]).
Note: The instant Claims contain a large amount of functional language (ex: “configured to store one or more cell processing reagents…”, “configured to receive a fluid device…”, “configured to measure a decontaminant concentration…”, etc.). However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
Further, with regards to the preamble including the limitation “for use in cell processing”, see MPEP 2111.02, which states that, “if the body of a claim fully and intrinsically sets forth all the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.”
Regarding claim 2, modified Katsumi discloses the reagent vault system of claim 1. Modified Katsumi further discloses that the sensor is a hydrogen peroxide sensor (see Claim 1 above at Blanchard teaching the hydrogen peroxide sensor in [0045]). Modified Katsumi further discloses that the reagent vault system further comprises a temperature sensor, a pressure sensor, a particulate sensor, a relative humidity sensor, or a combination thereof (Katsumi [0137]).
Regarding claim 5, modified Katsumi discloses the reagent vault system of claim 1, and all limitations recited therein.
Modified Katsumi fails to explicitly disclose that the decontaminant comprises a sterilant, and wherein the reagent vault system further comprises a sterilization nozzle to provide the sterilant to the fluid device.
Blanchard further teaches that the decontaminant comprises a sterilant (Blanchard; [0045], [0005], hydrogen peroxide solutions may be connected to or included in the incubator, [0027], the system may comprise hydrogen peroxide monitors). The system further comprises a sterilization dispensing means to provide the sterilant to a fluid device (Blanchard; [0045], [0005], [0027]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of modified Katsumi with the further teachings of Blanchard so that the decontaminant comprises a sterilant, and wherein the reagent vault system further comprises a sterilization nozzle to provide the sterilant to the fluid device. The motivation would have been to ensure that any reagents that are introduced into the reagent vault system are not contaminated, thereby ensuring that any processes that subsequently use the reagents are not contaminated.
Further, with regards to the sterilization dispensing means being a sterilization nozzle, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to select a nozzle for use to dispense a sterilant. The motivation would have been that nozzles are well known tools for dispensing fluids.
Regarding claim 6, modified Katsumi discloses the reagent vault system of claim 1. Modified Katsumi further discloses that the refrigeration unit is one of a plurality of refrigeration units of the reagent vault system (Katsumi; [0035]-[0036], [0060]-[0061], [0074], see Figs. 2, 6 at coolers 80, and reagent container racks 310, 320. The reagent container racks, in combination with the coolers, act as refrigeration units, as described in the Claim Interpretation section of this instant Office action. Each set of racks associated with one of the coolers can be considered a refrigeration unit under broadest reasonable interpretation. See MPEP 2111).
Regarding claim 7, modified Katsumi discloses the reagent vault system of claim 1. Modified Katsumi further discloses that the fluid device is one of a plurality of fluid devices of different sizes configured to be received in each slot (the fluid devices are not positively recited. Nevertheless, Katsumi teaches fluid devices of different size in [0063]).
Regarding claim 10, modified Katsumi discloses the reagent vault system of claim 1. Modified Katsumi further discloses a just-in-time feedthrough for loading one or more time-sensitive reagents into the reagent vault system (Katsumi; [0071], see Figs. 6-7 at reagent aspirating holes 71. These holes are capable of being used as feedthroughs for loading one or more time-sensitive reagents into the reagent vault system).
Regarding claim 11, modified Katsumi discloses the reagent vault system of claim 1. Modified Katsumi further discloses a cartridge feedthrough for loading one or more cartridges into the reagent vault system (Katsumi; [0070]-[0072], see Figs. 6-7 at movable lid 66. When this movable lid is opened, cartridges can be fed into the reagent storage 40).
Regarding claim 13, modified Katsumi discloses the reagent vault system of claim 1. Modified Katsumi further discloses that the refrigeration unit, the rotating carousel, and the sensor are housed within a single unit (Katsumi; [0035]-[0036], [0060]-[0061], [0074], [0137], the temperature sensor is arranged in the reagent storage, see Fig. 6 at coolers 80, and reagent container racks 310, 320 (i.e. the refrigeration units) and first reagent table 21 and second reagent table 22 (i.e. the rotating carousel) within the housing of reagent storage 40).
Modified Katsumi fails to explicitly disclose that the unit comprises an outer door for user access to the rotating carousel and an inner door for access to cell processing instruments within a sterile workcell.
Blanchard further teaches a unit that comprises an outer door for access to a first region, and an inner door for access to instruments within a sterile workcell (Blanchard; [0006], [0076], see Fig. 1 at external door 12 and transfer chamber door 14). An interlock locks the outer door when the inner door is open (Blanchard [0023]-[0026]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of modified Katsumi with the further teachings of Blanchard so that the unit comprises an outer door for user access to the rotating carousel and an inner door for access to cell processing instruments within a sterile workcell, where an interlock locks the outer door when the inner door is open. The motivation would have been to decrease the exposure of the internal chamber to the external environment, thereby preventing contamination within the system (Blanchard; [0004], [0006], [0023]-[0026], [0076], see Fig. 1).
Regarding claim 14, modified Katsumi discloses the reagent vault system of claim 13. Modified Katsumi further discloses an interlock, wherein the interlock locks the outer door when the inner door is open (see Claim 13 above at Blanchard teaching the interlock in [0023]-[0026]).
Regarding claim 20, modified Katsumi discloses the reagent vault system of claim 1, and all limitations recited therein. Modified Katsumi further discloses the controller, the sensor (see Claim 1 above at Blanchard teaching the sensor and controller in [0045], [0063]), and activating the sensor (in order for the sensor to be operational, it must intrinsically be activated).
Modified Katsumi fails to explicitly disclose that the controller is configured to activate the sensor and one or more of the scanner, an interlock, an alarm, and a robotic arm.
Blanchard further teaches a controller that is configured to activate a sensor and an interlock (Blanchard; [0045], [0063]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of modified Katsumi with the further teachings of Blanchard so that the controller is configured to activate the sensor and the interlock, as activating the sensor and the interlock can be used to decontaminate items passing into the internal chamber of the refrigeration unit using a transfer chamber, while also ensuring that the decontaminant used in the decontamination operation does not enter the internal chamber, thereby preventing decontamination and reducing undesirable condition fluctuations in the internal chamber (Blanchard; [0045], [0063], [0021]-[0022]).
Regarding claim 34, modified Katsumi discloses the reagent vault system of claim 1, and all limitations recited therein.
Modified Katsumi fails to explicitly disclose that each slot comprises an index feature configured to align with a corresponding index feature of the fluid device.
Blanchard further teaches an index feature in a storage area that is configured to align with a corresponding index feature of a fluid device (Blanchard [0122]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of modified Katsumi with the further teachings of Blanchard so that each slot comprises an index feature configured to align with a corresponding index feature of the fluid device, as Blanchard teaches that corresponding index features in a fluid device and a storage location can be used to securely hold a fluid device in place (Blanchard [0122]).
Regarding claim 35, modified Katsumi discloses the reagent vault system of claim 1. Modified Katsumi further discloses that the fluid device comprises a storage volume of 0.5 L or 1 L (the fluid device is not positively recited).
Regarding claim 41, modified Katsumi discloses the reagent vault system of claim 1, and all limitations recited therein.
Modified Katsumi fails to explicitly disclose that the decontaminant comprises one or more of ionized hydrogen peroxide, vaporized hydrogen peroxide, chlorine dioxide, or isopropyl mist.
Blanchard further teaches that the decontaminant comprises vaporized hydrogen peroxide (Blanchard [0045]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of modified Katsumi with the further teachings of Blanchard so that the decontaminant comprises vaporized hydrogen peroxide, as Blanchard teaches that vaporized hydrogen peroxide can be used to sterilize items in a laboratory setting (Blanchard [0045]).
Claims 1-2, 8-9, 12-14, 20, 33-38, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Buse et al. (US Pub. No. 2016/0060680; hereinafter Buse; already of record) in view of Hamel, Higo, and Blanchard.
Regarding claim 1, Buse discloses a reagent vault system for use in cell processing ([0244]-[0259], see Fig. 18 at reagent pack storage compartment 740, which includes a housing 742 that defines a temperature controlled chamber for cooling the compartment 740). The system comprises:
a refrigeration unit comprising a door and configured to store one or more cell processing reagents ([0244]-[0259], the storage apparatus has a door for a carousel access opening, see Fig. 18. The temperature controlled chamber within the reagent pack storage compartment 740 acts as a refrigeration unit, as described in the Claim Interpretation section of this instant Office action).
A rotating carousel within the refrigeration unit and comprising a radially arranged plurality of stacked slots, wherein each slot is configured to receive a fluid device, and wherein the fluid device is configured to store the one or more cell processing reagents ([0244]-[0259], see Fig. 18 at reagent pack storage compartment 740 holding reagent packs 760, which are arranged on storage carousel 744 having two levels. Further, see Fig. 16, which shows that carousels include reagent packs 760 that are radially arranged).
A scanner system comprising a scanner ([0244]-[0259], a barcode scanner scans each reagent pack).
Buse fails to explicitly disclose:
the rotating carousel comprises a radially arranged plurality of discrete columns, each column comprising a plurality of vertically stacked slots;
the scanner system is within the refrigeration unit and comprises:
a rail coupled to a sidewall of the refrigeration unit and extending in a direction along an axle of the rotating carousel and having a length about equal to a length of the axle; and
a scanner movable along the rail and configured to scan a fluid device received in each slot;
a sensor configured to measure a decontaminant concentration within the refrigeration unit; and
a controller configured to prevent opening of the door when the measured decontaminant concentration is above a threshold.
Hamel is in the analogous field of storage of materials used in reagent dispensing (Hamel; [0001], [0054]-[0060], see Figs. 1-3 at carousel 202 including stackers 222 in compartments 222, where magazines 300 can be loaded into stackers 222 via rails 230 so that magazines 300 are vertically stacked in the stackers 222. The magazines hold pipette tips 310). Hamel teaches a rotating carousel comprising a radially arranged plurality of discrete columns, each column comprising a plurality of vertically stacked slots (Hamel; [0054]-[0060], see Figs. 1-3 at carousel 202 including stackers 222 in compartments 222, where magazines 300 can be loaded into stackers 222 via rails 230 so that magazines 300 are vertically stacked in the stackers 222). A scanner system within a unit and comprising a rail coupled to a sidewall of the unit and extending in a direction along an axle of a rotating carousel, and a scanner movable along the rail and configured to scan a fluid device received in each slot (Hamel; [0050], [0054], [0068], see Figs. 3-4, 9A-9J, especially at sensor on upper gripper head 26, where gripper moves up and down on vertical rails 109, and Fig. 3 at axle 218 for carousel 202). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of Buse with the teachings of Hamel so that the rotating carousel comprises a radially arranged plurality of discrete columns, each column comprising a plurality of vertically stacked slots. The motivation would have been to provide a carousel having a configuration where the carousel can easily be rotated so that a desired component can be retrieved from inside the carousel for use (Hamel; [0054]-[0060], see Figs. 1-3). Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to choose the claimed carousel configuration, as taught by Hamel, from a finite number of identified, predictable ways to store components within a rotating carousel. The motivation would have been to allow an operator or gripping device to access all slots within a column at once, which would be beneficial if reagents for similar uses are grouped into a common column. Further, It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Buse with the teachings of Hamel so that the scanner system is within the refrigeration unit and comprises a rail coupled to a sidewall of the refrigeration unit and extending in a direction along an axle of the rotating carousel, and a scanner movable along the rail and configured to scan a fluid device received in each slot. The motivation would have been to be able to retrieve a new, unused fluid device from a slot in the carousel as desired (Hamel; [0050], [0068], see Figs. 3-4, 9A-9J).
Modified Buse fails to explicitly disclose:
the rail has a length about equal to a length of the axle;
a sensor configured to measure a decontaminant concentration within the refrigeration unit; and
a controller configured to prevent opening of the door when the measured decontaminant concentration is above a threshold.
Higo is in the analogous field of automatic analyzers (Higo Col. 1 Lns. 7-12). Higo teaches a rail that has a length approximately equal to the length of a processing area (Higo; Col. 4 Lns. 11-23, Col. 5 Lns. 7-17, see Fig. 1 at rail 46b on which movable scanning body 47 travels, where the rail is approximately the same length as test pack trays 41). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of modified Buse with the teachings of Higo so that the rail has a length about equal a length of the axle, so that the scanner can scan each fluid device within the system for retrieval, while also minimizing the size of the system, thereby conserving space.
Modified Buse fails to explicitly disclose:
a sensor configured to measure a decontaminant concentration within the refrigeration unit; and
a controller configured to prevent opening of the door when the measured decontaminant concentration is above a threshold.
Blanchard is in the analogous field of cell culture incubators (Blanchard [0005]) and teaches a unit that comprises a door (Blanchard; [0076]-[0081], see Fig. 1 at cell culture incubator 10 having an external door 12 and an internal door 14). A sensor is configured to measure a decontaminant concentration within the unit (Blanchard [0045]). A controller is configured to prevent opening of the door when the measured decontaminant concentration is above a threshold (Blanchard; [0045], [0063]). The controller is a hydrogen peroxide sensor (Blanchard [0045]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of modified Buse with the teachings of Blanchard so that the refrigeration unit comprises a door, a sensor configured to measure a decontaminant concentration within the refrigeration unit, and a controller configured to prevent opening of the door when the measured decontaminant concentration is above a threshold, where the controller is a hydrogen peroxide sensor. The motivation would have been to be able to decontaminate items passing into the internal chamber of the refrigeration unit using a transfer chamber, while also ensuring that the decontaminant used in the decontamination operation does not enter the internal chamber, thereby preventing decontamination and reducing undesirable condition fluctuations in the internal chamber (Blanchard; [0045], [0021]-[0022]). Further, hydrogen peroxide can be used as a sterilizing gas (Blanchard [0005]).
Further, with regards to the preamble including the limitation “for use in cell processing”, see MPEP 2111.02, which states that, “if the body of a claim fully and intrinsically sets forth all the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.”
Regarding claim 2, modified Buse discloses the reagent vault system of claim 1. Modified Buse further discloses that the sensor is a hydrogen peroxide sensor (see Claim 1 above at Blanchard teaching the hydrogen peroxide sensor in [0045]). Modified Buse further discloses that the reagent vault system further comprises a temperature sensor, a pressure sensor, a particulate sensor, a relative humidity sensor, or a combination thereof (Buse [0244]-[0259], a temperature sensor is located within the reagent pack storage compartment).
Regarding claim 8, modified Buse discloses the reagent vault system of claim 1. Modified Buse further discloses a robotic arm for transferring the fluid device from the rotating carousel to one or more instruments within a cell processing workcell (Buse; [0204], the rotary distributor is a 3 axis robot that includes a hook and rail system that pulls or pushes reagent packs into or from a distributor head of the rotary distributor, [0244]-[0259], the rotary distributor transfers reagent packs from the reagent pack input carousel to one or more levels of the storage carousel of the storage compartment).
Regarding claim 9, modified Buse discloses the reagent vault system of claim 8. Modified Buse further discloses that the robotic arm comprises a fluid device engagement feature end effector for coupling to the fluid device (Buse; [0204], [0244]-[0259]).
Regarding claim 12, modified Buse discloses the reagent vault system of claim 1. Modified Buse further discloses a waste unit (Buse [0244]-[0259], see Fig. 14 at waste chute 426).
Regarding claim 13, modified Buse discloses the reagent vault system of claim 1. Modified Buse further discloses that the refrigeration unit, the rotating carousel, and the sensor are housed within a single unit (Buse; [0244]-[0259], the temperature controlled chamber (refrigeration unit), storage carousel 744 (rotating carousel), and temperature sensor are within the storage compartment 740).
Modified Buse fails to explicitly disclose that the unit comprises an outer door for user access to the rotating carousel and an inner door for access to cell processing instruments within a sterile workcell.
Blanchard further teaches a unit that comprises an outer door for access to a first region, and an inner door for access to instruments within a sterile workcell (Blanchard; [0006], [0076], see Fig. 1 at external door 12 and transfer chamber door 14). An interlock locks the outer door when the inner door is open (Blanchard [0023]-[0026]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of modified Buse with the further teachings of Blanchard so that the unit comprises an outer door for user access to the rotating carousel and an inner door for access to cell processing instruments within a sterile workcell, where an interlock locks the outer door when the inner door is open. The motivation would have been to decrease the exposure of the internal chamber to the external environment, thereby preventing contamination within the system (Blanchard; [0004], [0006], [0023]-[0026], [0076], see Fig. 1).
Regarding claim 14, modified Buse discloses the reagent vault system of claim 13. Modified Buse further discloses an interlock, wherein the interlock locks the outer door when the inner door is open (see Claim 13 above at Blanchard teaching the interlock in [0023]-[0026]).
Regarding claim 20, modified Buse discloses the reagent vault system of claim 1, and all limitations recited therein. Modified Buse further discloses the controller, the sensor (see Claim 1 above at Blanchard teaching the sensor and controller in [0045], [0063]), and activating the sensor (in order for the sensor to be operational, it must intrinsically be activated).
Modified Buse fails to explicitly disclose that the controller is configured to activate the sensor and one or more of the scanner, an interlock, an alarm, and a robotic arm.
Blanchard further teaches a controller that is configured to activate a sensor and an interlock (Blanchard; [0045], [0063]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of modified Buse with the further teachings of Blanchard so that the controller is configured to activate the sensor and the interlock, as activating the sensor and the interlock can be used to decontaminate items passing into the internal chamber of the refrigeration unit using a transfer chamber, while also ensuring that the decontaminant used in the decontamination operation does not enter the internal chamber, thereby preventing decontamination and reducing undesirable condition fluctuations in the internal chamber (Blanchard; [0045], [0063], [0021]-[0022]).
Regarding claim 33, modified Buse discloses the reagent vault system of claim 1. Modified Buse further discloses that the axle is coupled to a motor (Buse; [0244]-[0259], see Fig. 18 at shaft 745 coupled to motor 748 for rotating the storage carousel 744).
Modified Buse fails to explicitly disclose that each plurality of stacked slots is arranged along the rotating axle.
Hamel further teaches that each of a plurality of stacked slots is arranged along a rotating axle (Hamel; [0054]-[0060], see Figs. 1-3 at carousel 202 including stackers 222 in compartments 222, where magazines 300 can be loaded into stackers 222 via rails 230 so that magazines 300 are vertically stacked in the stackers 222. The magazines hold pipette tips 310. Each of the stackers 222 are arranged along the rotating axle 218). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of modified Buse with the further teachings of Hamel so that each plurality of stacked slots is arranged along the rotating axle. The motivation would have been to provide a carousel having a configuration where the carousel can easily be rotated so that a desired fluid device can be retrieved from inside the carousel for use (Hamel; [0054]-[0060], see Figs. 1-3). Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to choose the claimed carousel configuration, as taught by Hamel, from a finite number of identified, predictable ways to store components within a rotating carousel. The motivation would have been to allow an operator or gripping device to access all slots within a column at once, which would be beneficial if reagents for similar uses are grouped into a common column.
Regarding claim 34, modified Buse discloses the reagent vault system of claim 1, and all limitations recited therein.
Modified Buse fails to explicitly disclose that each slot comprises an index feature configured to align with a corresponding index feature of the fluid device.
Blanchard further teaches an index feature in a storage area that is configured to align with a corresponding index feature of a fluid device (Blanchard [0122]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of modified Buse with the further teachings of Blanchard so that each slot comprises an index feature configured to align with a corresponding index feature of the fluid device, as Blanchard teaches that corresponding index features in a fluid device and a storage location can be used to securely hold a fluid device in place (Blanchard [0122]).
Regarding claim 35, modified Buse discloses the reagent vault system of claim 1. Modified Buse further discloses that the fluid device comprises a storage volume of 0.5 L or 1 L (the fluid device is not positively recited).
Regarding claim 36, modified Buse discloses the reagent vault system of claim 1, and all limitations recited therein. Modified Buse further discloses that the scanner system further comprises a proximity sensor (Buse [0241]).
Regarding claim 37, modified Buse discloses the reagent vault system of claim 36, and all limitations recited therein.
Modified Buse fails to explicitly disclose that the proximity sensor is configured to detect one or more of a presence, absence, and position of the fluid device within each slot of the plurality of radially arranged and stacked slots.
Higo further teaches a proximity sensor that is configured to detect a presence of a device within a region (Higo; Col. 2 Lns. 14-41, Col. 3 Lns. 10-27, to detect the presence of a test pack within a test pack drawer, an optical detector detects reflected light rays from a top seal of a test pack). The proximity sensor is configured to detect a color on an external surface of the device (Higo; Col. 2 Lns. 14-41, Col. 3 Lns. 10-27, the optical detecting means detects a material painted in a light with color on the top seal of the test pack). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of modified Buse with the further teachings of Higo so that the proximity sensor is configured to detect one or more of a presence, absence, and position of the fluid device within each slot of the plurality of radially arranged and stacked slots, the proximity sensor configured to detect a color on an external surface of the device. The motivation would have been to determine if a fluid device is present for subsequent processing, as well as to determine if a fluid device is already present within a slot to determine if a fluid device can be stored within the slot. Further, Higo teaches that an optical device can detect a surface painted with a color in order to determine the presence or absence of an object (Higo; Col. 2 Lns. 14-41, Col. 3 Lns. 10-27).
Regarding claim 38, modified Buse discloses the reagent vault system of claim 37, and all limitations recited therein. Modified Buse further discloses that the proximity sensor is configured to detect a color on an external surface of the fluid device (see Claim 37 above at Higo teaching the proximity sensor configured to detect a color on an external surface in Col. 2 Lns. 14-41, Col. 3 Lns. 10-27).
Regarding claim 41, modified Buse discloses the reagent vault system of claim 1, and all limitations recited therein.
Modified Buse fails to explicitly disclose that the decontaminant comprises one or more of ionized hydrogen peroxide, vaporized hydrogen peroxide, chlorine dioxide, or isopropyl mist.
Blanchard further teaches that the decontaminant comprises vaporized hydrogen peroxide (Blanchard [0045]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of modified Buse with the further teachings of Blanchard so that the decontaminant comprises vaporized hydrogen peroxide, as Blanchard teaches that vaporized hydrogen peroxide can be used to sterilize items in a laboratory setting (Blanchard [0045]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Katsumi in view of Hamel, Higo, and Blanchard, as applied to claims 1-2, 5-7, 10-11, 13-14, 20, 34-35, and 41 above, further in view of Watari et al. (US Pat. No. 6,891,182; hereinafter Watari; already of record).
Regarding claim 4, modified Katsumi discloses the reagent vault system of claim 1. Modified Katsumi further discloses that the scanner is configured to scan a bar code on the fluid device (Katsumi; [0041], see Fig. 6 at reagent barcode reader 33).
Modified Katsumi fails to explicitly disclose that the scanner is configured to detect a size of the fluid device.
Watari is in the analogous field of automatic analyzers (Watari Col. 1 Lns. 8-10) and teaches a scanner that is configured to scan a bar code and detect a size of a fluid device (Watari Col. 3 Ln. 32-Col. 4 Ln. 41). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of modified Katsumi with the teachings of Watari so that the scanner is configured to detect a size of the fluid device in addition to scanning a bar code, as Watari teaches that a scanner that can perform both functions will eliminate the need for dedicated sensors to perform both functions, thereby reducing operational costs and improving maintenance capacity (Watari Col. 4 Lns. 32-41). Further, there is a need to detect the size of fluid devices in the system of Katsumi, as Katsumi teaches that containers of different sizes should be placed in different racks (Katsumi [0063]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Buse in view of Hamel, Higo, and Blanchard, as applied to claims 1-2, 8-9, 12-14, 20, 33-38, and 41 above, further in view of Watari.
Regarding claim 4, modified Buse discloses the reagent vault system of claim 1. Modified Buse further discloses that the scanner is configured to scan a bar code on the fluid device (Buse [0244]-[0259], a barcode scanner scans each reagent pack).
Modified Buse fails to explicitly disclose that the scanner is configured to detect a size of the fluid device.
Watari is in the analogous field of automatic analyzers (Watari Col. 1 Lns. 8-10) and teaches a scanner that is configured to scan a bar code and detect a size of a fluid device (Watari Col. 3 Ln. 32-Col. 4 Ln. 41). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of modified Buse with the teachings of Watari so that the scanner is configured to detect a size of the fluid device in addition to scanning a bar code, as Watari teaches that a scanner that can perform both functions will eliminate the need for dedicated sensors to perform both functions, thereby reducing operational costs and improving maintenance capacity (Watari Col. 4 Lns. 32-41).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Katsumi in view of Hamel, Higo, and Blanchard, as applied to claims 1-2, 5-7, 10-11, 13-14, 20, 34-35, and 41 above, further in view of Gerlinghaus et al. (US Pub. No. 2021/0283565; hereinafter Gerlinghaus; already of record).
Regarding claim 15, modified Katsumi discloses the reagent vault system of claim 10, and all limitations recited therein.
Modified Katsumi fails to explicitly disclose that decontaminant comprises a sterilant, and that the just-in-time feedthrough comprises a sterilization nozzle to provide sterilant to the one or more time-sensitive reagents.
Blanchard further teaches that the decontaminant comprises a sterilant (Blanchard; [0045], [0005], hydrogen peroxide solutions may be connected to or included in the incubator, [0027], the system may comprise hydrogen peroxide monitors). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of modified Katsumi with the further teachings of Blanchard so that the decontaminant comprises a sterilant. The motivation would have been to ensure that any reagents that are introduced into the reagent vault system are not contaminated, thereby ensuring that any processes that subsequently use the reagents are not contaminated.
Modified Katsumi fails to explicitly disclose that the just-in-time feedthrough comprises a sterilization nozzle to provide sterilant to the one or more time-sensitive reagents.
Gerlinghaus is in the analogous field of systems for cell processing (Gerlinghaus [0005]). Gerlinghaus teaches a feedthrough that comprises a sterilization dispensing means to provide sterilant to one or more time-sensitive reagents (Gerlinghaus; [0246], see Fig. 2E at cartridge 250 in feedthrough 206. Chemical sterilizing agents may pass through the feedthrough 206 to sterilize the cartridges, e.g. by spray or washing). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of modified Katsumi with the teachings of Gerlinghaus so that the just-in-time feedthrough comprises a sterilization dispensing means to provide sterilant to the one or more time-sensitive reagents. The motivation would have been to ensure that any reagents that are introduced into the reagent vault system are not contaminated, thereby ensuring that any processes that subsequently use the reagents are not contaminated.
Further, with regards to the sterilization dispensing means being a sterilization nozzle, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to select a nozzle for use to dispense a sterilant. The motivation would have been that nozzles are well known tools for dispensing fluids.
Claims 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Katsumi in view of Hamel, Higo, and Blanchard, as applied to claims 1-2, 5-7, 10-11, 13-14, 20, 34-35, and 41 above, further in view of Chaffey et al. (US Pub. No. 2012/0293338; hereinafter Chaffey; already of record).
Regarding claim 16, modified Katsumi discloses the reagent vault system of claim 2, and all limitations recited therein. Modified Katsumi further discloses that the reagent vault system comprises the temperature sensor (Katsumi [0137]).
Modified Katsumi fails to explicitly disclose an alarm for alerting a user when the temperature sensor measures a temperature greater than a temperature threshold.
Chaffey is in the analogous field of storage systems (Chaffey [0001]), and teaches an alarm for alerting a user when a temperature sensor measures a temperature greater than a temperature threshold (Chaffey; [0007], [0016]-[0023], [0095], [0123]). The alarm is a visual alarm or audible alarm (Chaffey; [0123], [0125]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of modified Katsumi with the teachings of Chaffey to include an alarm for alerting a user when a temperature sensor measures a temperature greater than a temperature threshold, the alarm being a visual alarm or audible alarm, as Chaffey teaches that this alarm can alert a user that appropriate corrective action should be taken to maintain integrity of the stored materials (Chaffey; [0002], [0007], [0016]-[0023], [0095], [0123], [0125]).
Regarding claim 17, modified Katsumi discloses the reagent vault system of claim 16, and all limitations recited therein.
Modified Katsumi fails to explicitly disclose that the temperature threshold is between about 2 degrees C and about 8 degrees Celsius.
However, Katsumi teaches that the ideal temperature for the reagent storage is about 10 degrees Celsius (Katsumi [0060]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of modified Katsumi so that the temperature threshold is between about 2 degrees C and about 8 degrees Celsius, since a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985), and MPEP 2144.05(I). The motivation for providing a threshold temperature that is in this range would be to ensure that an operator is notified when the temperature exceeds this range, thereby enabling an operator to take corrective action to keep the reagents stored at their optimal storage temperature.
Regarding claim 18, modified Katsumi discloses the reagent vault system of claim 16. Modified Katsumi further discloses that the alarm is one or more of an audible alarm, a visual alarm, and a virtual alarm (see Claim 16 above at Chaffey teaching an audible or visual alarm in [0123], [0125]).
Claims 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Buse in view of Hamel, Higo, and Blanchard, as applied to claims 1-2, 8-9, 12-14, 20, 33-38, and 41 above, further in view of Chaffey.
Regarding claim 16, modified Buse discloses the reagent vault system of claim 2, and all limitations recited therein. Modified Buse further discloses that the reagent vault system comprises the temperature sensor (Buse [0244]-[0259], a temperature sensor is located within the reagent pack storage compartment).
Modified Buse fails to explicitly disclose an alarm for alerting a user when the temperature sensor measures a temperature greater than a temperature threshold.
Chaffey is in the analogous field of storage systems (Chaffey [0001]), and teaches an alarm for alerting a user when a temperature sensor measures a temperature greater than a temperature threshold (Chaffey; [0007], [0016]-[0023], [0095], [0123]). The alarm is a visual alarm or audible alarm (Chaffey; [0123], [0125]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of modified Buse with the teachings of Chaffey to include an alarm for alerting a user when a temperature sensor measures a temperature greater than a temperature threshold, the alarm being a visual alarm or audible alarm, as Chaffey teaches that this alarm can alert a user that appropriate corrective action should be taken to maintain integrity of the stored materials (Chaffey; [0002], [0007], [0016]-[0023], [0095], [0123], [0125]).
Regarding claim 17, modified Buse discloses the reagent vault system of claim 16, and all limitations recited therein.
Modified Buse fails to explicitly disclose that the temperature threshold is between about 2 degrees C and about 8 degrees Celsius.
However, Buse teaches that the ideal temperature for the reagent storage is between 4 to 14 degrees Celsius (Buse [0246]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of modified Buse so that the temperature threshold is between about 2 degrees C and about 8 degrees Celsius, since a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985), and MPEP 2144.05(I). The motivation for providing a threshold temperature that is in this range would be to ensure that an operator is notified when the temperature exceeds this range, thereby enabling an operator to take corrective action to keep the reagents stored at their optimal storage temperature.
Regarding claim 18, modified Buse discloses the reagent vault system of claim 16. Modified Buse further discloses that the alarm is one or more of an audible alarm, a visual alarm, and a virtual alarm (see Claim 16 above at Chaffey teaching an audible or visual alarm in [0123], [0125]).
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Buse in view of Hamel, Higo, and Blanchard, as applied to claims 1-2, 8-9, 12-14, 20, 33-38, and 41 above, further in view of Gwynn et al. (US Pub. No. 2013/0132006; hereinafter Gwynn; already of record).
Regarding claim 40, modified Buse discloses the reagent vault system of claim 36, and all limitations recited therein.
Modified Buse fails to explicitly disclose that the scanner system further comprises a linear encoder configured to determine a position of one or more of the scanner or the proximity sensor.
Gwynn is in the analogous field of systems and method for processing and analyzing samples (Gwynn [0019]). Gwynn teaches a linear encoder configured to determine a position of one or more of a scanner or a proximity sensor system (Gwynn; [0609], the transport device 110 includes a linear encoder reader that provides positional information and feedback to a controller. Further, the linear encoder reader appears capable of determining a position of a scanner, proximity sensor, or linear encoder within a system). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of modified Buse with the teachings of Gwynn so that the scanner system further comprises a linear encoder configured to determine a position of one or more of the scanner or the proximity sensor. The motivation would have been to be able to provide positional information and feedback to a controller regarding the location of the scanner (Gwynn [0609]), particularly as the scanner of Hamel moves along a rail (Hamel; [0050], [0054], [0068], see Figs. 3-4, 9A-9J, especially at sensor on upper gripper head 26, where gripper moves up and down on vertical rails 109, and Fig. 3 at axle 218 for carousel 202), thereby allowing the positional location of the fluid devices scanned by the scanner to be known for subsequent retrieval and processing.
Response to Arguments
Applicant's arguments filed January 7, 2026 have been fully considered but they are not persuasive.
Applicant argues on Pgs. 7-8 of their Remarks that the prior art of record does not teach a scanner system with a rail movable thereon, where the rail extends in a direction along an axle of the rotating carousel, or where the rail has a length about equal to a length of the axle. The Examiner respectfully disagrees, and points to the references Hamel and Higo already on the record, which teach the above limitations. The Examiner has cited Hamel to teach a rail extending in a direction along an axle of a rotating carousel, and Higo to teach a rail that has a length approximately equal to a length of a processing area. As the length of the processing area of Hamel corresponds to the length of the axle of the rotating carousel of Hamel, Hamel in view of Higo teaches the claimed limitation. For a more detailed explanation, please see the rejections of Claim 1 (one using Buse as a primary reference, the other using Katsumi as a primary reference) in the Claim Rejections-35 USC 103 section of this instant Office Action.
Applicant further argues on Pgs. 8-9 of their Remarks that Higo cannot be used to teach a scanner system with a rail movable thereon, where the rail extends in a direction along an axle of the rotating carousel, or where the rail has a length about equal to a length of the axle, as Higo teaches that the guide rails are oriented horizontally, and do not operate in a vertical orientation. While the Examiner agrees that Higo does not teach vertical rails, Hamel does teach vertical rails, at (Hamel; [0050], [0054], [0068], see Figs. 3-4, 9A-9J, especially at sensor on upper gripper head 26, where gripper moves up and down on vertical rails 109, and Fig. 3 at axle 218 for carousel 202).
Applicant further argues on Pgs. 9-10 of their Remarks that Buse’s storage compartment provides no structural accommodation for the claimed scanning system, as Buse’s carousel is flush with the internal dimensions of the housing. However, this argument amounts to stating that Buse cannot be modified with any prior art teaching the claimed scanning system, as the prior art devices are not physically combinable. However, it is well-established that a determination of obviousness based on teachings from multiple references does not require an actual, physical substitution of elements, but rather depends on whether the claimed inventions are rendered obvious by the teachings of the prior art as a whole. See In re Mouttet, 686 F.3d 1322, 1332, 103 USPQ2d 1219, 1226 (Fed. Cir. 2012), and MPEP 2145(III).
Applicant further argues on Pg. 10 of their Remarks that the barcode reader of Buse is intentionally provided outside of the compartment/housing interior, and therefore there would be no reason to modify Buse to include a movable scanner within the storage compartment itself. Applicant further argues that modifying Buse to include a movable scanner may obstruct reagent pack loading paths, which would render Buse’s system inoperable for its intended use. The Examiner respectfully disagrees on both counts. Hamel teaches a carousel system having a gripper/sensor that moves up and down on vertical rails to retrieve fluid devices within a carousel (Hamel; [0050], [0054], [0068], see Figs. 3-4, 9A-9J, especially at sensor on upper gripper head 26, where gripper moves up and down on vertical rails 109, and Fig. 3 at axle 218 for carousel 202), and provides motivation to modify the device of Buse to include a movable scanner.
Applicant further argues on Pgs. 10-11 of their Remarks that none of the prior art of record teach a rail extending in a direction along an axle of the rotating carousel or to have a length about equal to a length of the axle. However, the Examiner respectfully disagrees. As previously addressed in the Response to Arguments section above, Hamel in view of Higo teaches the claimed limitation.
Conclusion
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/JOHN MCGUIRK/Examiner, Art Unit 1798