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 .
Response to Arguments
Applicant’s arguments, see Remarks page 7, filed 18 May 2026, with respect to the rejection of the claims under 35 U.S.C. 101 have been fully considered and are persuasive in light of the amendments to the claims. The rejection of the claims has been withdrawn.
Applicant’s addition of the limitations in claim 1 that the system is caused to “aspirate a volume of liquid from the reagent vessel at the actual location for that reagent vessel,” in claim 16 of a system “aspirating, using the pipettor, the volume of liquid from the reagent vessel at an actual location for that reagent vessel,” and in claim 17 of “aspirating a volume of liquid from at least one reagent vessel at an actual location for the at least one reagent vessel” provide a particular, practical application. Accordingly, the claims are directed to eligible subject matter.
Applicant’s arguments, see Remarks page 13, filed 18 May 2026, with respect to the rejections of claims 1, 3-5, 6-13, 15, and 17 under 35 USC 103 have been fully considered and are persuasive in light of the amendments to the claims. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Davis et al in view of Klumph et al and further in view of Wasson et al.
Applicant's arguments filed 18 May 2026, with respect to the rejections of claims 14 and 16 have been fully considered but they are not persuasive.
The disclosure of Davis et al teaches a device which images an automated laboratory apparatus to verify the location of components. Davis et al does explicitly teach that the apparatus may include automated fluid handling features (e.g. [0030]), that the automated fluid handling may operate off of a protocol ([0008], “…a fluid handling system for preparing a sample according to a programmed protocol.”), and that the protocol may be updated (([0079], “…deck setup instructions may be dynamically modified in response to component verification…”; [0043], “…the instructions module may be configured for generating the programmed protocol.”). However, the disclosure of Davis et al focuses on providing instructions to a user, and nowhere does Davis et al explicitly teach directing the fluid module to an updated location specified in a protocol. As such, the examiner agrees that the amendments filed 18 May 2026 overcome the previously applied rejection of Davis et al in view of Klumph.
However, the examiner disagrees with applicant’s arguments regarding Wasson et al. Wasson et al teaches that an automated fluid handling system may track the location of a reagent vessel, and then direct the fluid handling system to select individual reagents (see e.g. [1200]). This teaching reads on the broadest reasonable interpretation of amended claim 1’s limitation that the system is controlled to “aspirate a volume of liquid from the reagent vessel at the actual location for that reagent vessel.” Ultimately, the system of Davis et al in view of Klumph et al teaches an automated workstation that can track reagents, and Wasson et al teaches that an automated workstation which tracks reagent locations can access the reagents at their actual location. Please see the detailed rejection of claims 1, 14, 16, and 17 for further details.
Status of Claims
Applicant's amendments to the claims filed 18 May 2026 have been entered. Applicant's remarks filed 18 May 2026 are acknowledged.
Claims 1, 16, and 17 are in status “Currently amended.” Claims 3 – 15 are in status “Original” or “Previously presented.” Claim 2 is canceled.
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 – 17 are rejected under 35 U.S.C. 103 as being unpatentable over Davis et al (US 20220276274 A1, effectively filed 23 August 2019) in view of Klumph et al (WO 2017095702 A1) and further in view of Wasson et al (US 20160124009 A1, cited on the IDS filed 25 April 2025.).
The applied reference has a common assignee and inventors with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
With regards to claim 1, Davis et al teaches;
The claimed “A fluid handling system” has been read on the taught ([0007], “…the laboratory workstation may include a fluid handling system.”);
The claimed “a processor” has been read on the taught ([0007], “The workstation may further include a processor…”);
The claimed “a vessel holder comprising a plurality of pedestals including a pedestal” has been read on the taught ([0032], “The deck 104 may include a platform or surface configured for receiving samples, reagents, vials, and/or other labware.”; [0007], “The labware item may include a […] carousel…”; A carousel reads on a pedestal. A deck configured to receive carousels reads on a vessel holder comprising a plurality of pedestals.);
The claimed “the vessel holder being configured to receive the plurality of reagent vessels at a corresponding plurality of pedestal locations including a reagent vessel received at the pedestal” has been read on the taught ([0008], “Determining whether the loaded item of labware has been loaded in accordance with the programmed protocol may include […] identifying a location on the deck of the loaded item…”; A location on the deck reads on a plurality of pedestal locations.);
The claimed “each reagent vessel having visual indicators of identifying features located on an identification label” has been read on the taught ([0061], “…the verification module may be configured to read barcodes, quick response (QR) codes, or other codes, labels, or identifiers in an image…”; Labels or identifiers read on the reagent vessels having visual indicators. See also [0081] teaching a reaction vessel with a barcode indicator.);
The claimed “an imaging device” has been read on the taught ([0007], “The workstation may additionally include an imaging device configured to monitor the deck of the laboratory workstation by creating one or more images of the deck.”);
The claimed “a non-transitory, computer-readable storage medium including a programmed protocol for processing the sample including a listing of reagents, and comprising computer readable instructions” has been read on the taught ([0007], “…the programmed protocol may call for a plurality of items of labware to be arranged on the deck…”; [0041], “…the database 110 may be a remote or local storage device. The database 110 may store programmed protocols, each associated with a particular deck setup configuration.”);
The claimed instructions to “capture a plurality of images of the plurality of reagent vessels using the imaging device; recognize the visual indicators in the plurality of images and each image and to identify a reagent in each of the plurality of reagent vessels based on the recognized visual indicators; determine if appropriate reagents have been loaded into the vessel holder as specified in the listing of reagents; determine if a loaded location of the reagent vessel for each identified reagent corresponds to an expected location for that reagent vessel as specified in the programmed protocol” has been read on the taught ([0009], “The method may additionally include monitoring the deck by creating one or more images of the deck using an imaging device. The method may further include, from the one or more images of the deck, identifying an item of labware loaded onto the deck by an operator. The method may include, from the one or more images of the deck, determining whether the item of labware is arranged on the deck in accordance with the programmed protocol…”);
The claimed instructions to “when the loaded location of at least one reagent vessel does not correspond to the expected location for that reagent vessel, update the programmed protocol to direct the fluid handling system to access that reagent vessel at an actual location for that reagent vessel” has been read on the taught ([0079], “…deck setup instructions may be dynamically modified in response to component verification…”; [0043], “…the instructions module may be configured for generating the programmed protocol.”; Generating the programmed protocol reads on updating the programmed protocol to direct the fluid handling system.).
However, Davis et al does not explicitly teach a motor configured to rotate the pedestal or instructions to rotate the pedestal and reagent vessel using a motor, and to aspirate a volume of liquid from the reagent vessel at the actual location for that reagent vessel.
In the analogous art of fluid handling systems including imaging devices, Klumph et al teaches;
The claimed “a vessel holder comprising a plurality of pedestals including a pedestal” has been read on the taught ([0004], “…a compounder system is provided that includes a vial tray having a vial opening for receiving a vial containing a drug…”);
The claimed “a motor configured to rotate the pedestal” has been read on the taught ([0004], “…a second motor configured to rotate the vial while the camera captures images of a label on the vial…”);
The claimed “instructions that cause the fluid handling system to rotate the pedestal and reagent vessel using the motor; capture a plurality of images of the plurality of reagent vessels using the imaging device” has been read on the taught ([0005], “a method is provided that includes […] rotating the vial while the vial is in the vial tray at the imaging location; capturing at least one image of the label while rotating the vial; and determining at least one of a lot number and an expiration date from the at least one image.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device including a carousel as taught by Davis et al with the motor configured to rotate and instructions including rotation as taught by Klumph et al, for the benefit of an improved system which can scan a vial label regardless of the initial orientation of the vial (Klumph et al, [0073], “…the inserted vial 18 may be rotated within its position in vial tray 22 using a vial rotation motor 2602 to allow the vial label to be scanned.”).
However, Davis et al in view of Klumph et al does not explicitly disclose wherein the system includes instructions that cause the fluid handling system to aspirate a volume of liquid from the reagent vessel at the actual location for that reagent vessel.
In the analogous art of automated fluid handling systems, Wasson et al teaches;
The claimed “instructions that cause the fluid handling system to […] aspirate a volume of liquid from the reagent vessel at the actual location for that reagent vessel” has been read on the taught ([1388], “The controller may, based on the signals from the sensors, effect a change in a component or maintain the state of a unit. For example, the controller […] determine a protocol to run on a particular assay sample, move a vessel and/or tip, or dispense and/or aspirate a sample.”; [1200], “The location of each reagent unit may be tracked. A reagent unit may be individually selected to receive and/or provide a fluid.”; The reagent unit having a tracked location which may be individually selected reads on the pipettor aspirating a volume of liquid from the reagent vessel at the actual location for that reagent vessel.).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the fluid handling system as taught by Davis et al in view of Klumph with the processor configured to direct a pipettor as taught by Wasson et al. According to MPEP 2143(I)(C), use of a known technique to improve similar devices in the same way may be prima facie obvious. In the case of the instant invention, the prior art of Davis et al in view Klumph et al contains a “base” device of an automated pipetting system, upon which the claimed invention can be seen as an “improvement.” The prior art of Wasson et al contains a “comparable” device that has been improved in the same way as the claimed invention, with tracked locations of various vessels. One of ordinary skill in the art could have applied the known indicator improvement in the same way to the base device, for the predictable result of an improved system which can pipette automatically regardless of the deck set-up.
With regards to claim 3, the device of claim 1 is obvious over Davis et al in view of Klumph et al and further in view of Wasson et al.
Neither Davis et al nor Wasson et al explicitly disclose wherein each of the plurality of reagent vessels loaded into the vessel holder is rotatable along a central axis of the reagent vessel.
Klumph et al additionally teaches the claimed “wherein each of the plurality of reagent vessels loaded into the vessel holder is rotatable along a central axis of the reagent vessel” has been read on the taught (Abstract, “The system may rotate the vial while capturing the images to capture images of the entire vial.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device including a carousel as taught by Davis et al in view of Klumph et al in view of Wasson et al with the device wherein each of the reagent vessels is rotatable along a central axis of the reagent vessel as taught by Klumph et al, for the benefit of creating an improved system which can image the entire vial (Klumph et al, Abstract, “The system may rotate the vial while capturing the images to capture images of the entire vial.”).
With regards to claim 4, the device of claim 3 is obvious over Davis et al in view of Klumph et al and further in view of Wasson et al.
Neither Davis et al nor Wasson et al explicitly disclose wherein the imaging device is configured to produce a composite image of each of the plurality of reagent vessels via slit-scan imaging.
Klumph et al additionally teaches the claimed “wherein the imaging device is configured to produce a composite image of each of the plurality of reagent vessels via slit-scan imaging” has been read on the taught ([0081], “Light source 2702 may be a line- wise light source configured to illuminate a vertical line on the vial while the vial is rotated so that each captured image includes an image of a vertical line on the vial. The vertical line images may be combined using processing circuitry associated with the camera and/or processing circuitry such as one or more processors for the compounder system to form a rectilinear image of the entire vial label.”; Forming a rectilinear image of the entire vial label reads on slit-scan imaging.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device according to claim 3 including an imaging device with the slit-scan imaging as taught by Klumph et al, for the benefit of creating an improved system which can form a single rectilinear image of an entire vial label (Klumph et al, [0081], “The vertical line images may be combined using processing circuitry associated with the camera and/or processing circuitry such as one or more processors for the compounder system to form a rectilinear image of the entire vial label.”).
With regards to claim 6, the device of claim 1 is obvious over Davis et al in view of Klumph et al and further in view of Wasson et al.
Davis et al additionally teaches the claimed “wherein the vessel holder is a reagent carousel rotatable along a central axis of the reagent carousel” as read on the taught ([0032], “The deck 104 may include a platform or surface configured for receiving samples, reagents, vials, and/or other labware.”; [0007], “The labware item may include a […] carousel…”).
With regards to claim 7, the device of claim 1 is obvious over Davis et al in view of Klumph et al and further in view of Wasson et al.
Davis et al additionally teaches the claimed “wherein the imaging device has a field of view configured to simultaneously image the plurality of reagent vessels in the vessel holder” as read on the taught ([0035], “The imaging device 108 may be arranged on or within the deck housing 102 and may be configured to capture images of the deck 104 and/or components arranged on the deck.”; Capturing images of the deck and components arranged on the deck reads on being configured to simultaneously image the plurality of reagent vessels.).
With regards to claim 8, the device of claim 1 is obvious over Davis et al in view of Klumph et al and further in view of Wasson et al.
Neither Davis et al nor Wasson et al explicitly disclose wherein the non-transitory, computer-readable storage medium includes a database including visual indicators for reagent vessels from different manufacturers including a lot number and an expiration date.
Klumph et al additionally teaches the claimed “wherein the non-transitory, computer-readable storage medium includes a database including visual indicators for reagent vessels from different manufacturers including a lot number and an expiration date” as read on the taught ([0097], “…a compounder system may determine whether the read barcode is in a database of known barcodes…”; [0098], “If […] the barcode is in the database, label information associated with that barcode […] may be accessed and […] the system may search for the expiration date and/or lot number…”; [0056], “The lot number and expiration date may be compared with other information such as the current date, recall or other instructions associated with the lot number…”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device as taught by Davis et al in view of Klumph et al in view of Wasson et al to include a database with lot numbers and expiration dates as taught by Klumph et al, for the benefit of creating an improved system which supports productivity reporting and other activities (Klumph et al, [0056], “In this way, the lot number and/or expiration date from an imaged label can be used to support activities, such as productivity reporting. […] As another example, a pharmacist can search the hospital/pharmacy inventory database and determine an inventory level of drugs associated with this lot number and expiration date.”).
With regards to claim 9, the device of claim 8 is obvious over Davis et al in view of Klumph et al and further in view of Wasson et al.
Neither Davis et al nor Wasson et al explicitly disclose wherein the processor is configured to compare visual indicators in the database to decipher the visual indicators in the images.
Klumph et al additionally teaches the claimed “wherein the processor is configured to compare visual indicators in the database to decipher the visual indicators in the images” as has been read on the taught ([0091], “The OCR operations may then include performing OCR operations that are informed by the label information (e.g., by searching for characters in 8 point red font, horizontally oriented, and only in a portion of the image at the bottom right corner of the label image).”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Davis et al in view of Klumph et al in view of Wasson et al to include the processor configured to compare visual indicators in the database to decipher visual indicators in the images. According to MPEP 2143(I)(C), use of a known technique to improve similar devices in the same way may be prima facie obvious. In the case of the instant invention, the prior art of Davis et al in view Klumph et al contains a “base” device of a fluid processing system including a processor, upon which the claimed invention can be seen as an “improvement.” The prior art of Klumph et al contains a “comparable” device that has been improved in the same way as the claimed invention, with a processor configured to compare visual indicators between an image and a database. One of ordinary skill in the art could have applied the known processor improvement in the same way to the base device, for the predictable result of an improved system which can link a variety of visual indicators to pre-determined meanings.
With regards to claim 10, the device of claim 8 is obvious over Davis et al in view of Klumph et al and further in view of Wasson et al.
Davis et al additionally teaches the claimed “wherein the processor is configured to compare the deciphered visual indicators in the images to information in the programmed protocol” as read on the taught ([0007], “The workstation may further include a processor configured to recognize, in the one or more images created by the imaging device, an item of labware loaded onto the deck by an operator. […] The instruction may include a checklist in some embodiments, and the processor may be configured to indicate on the display whether the item of labware loaded onto the deck by the operator is an item on the checklist.”).
With regards to claim 11, the device of claim 1 is obvious over Davis et al in view of Klumph et al and further in view of Wasson et al.
Davis et al additionally teaches the claimed “wherein the fluid handling system is configured to determine a level of liquid within a reagent vessel; and the processor is further configured to confirm sufficient volume of liquid is contained in the reagent vessel according the programmed protocol” as read on the taught ([0007], “…the programmed protocol may call for a plurality of items of labware to be arranged on the deck, and the processor may be configured to recognize each of the plurality of items of labware... The labware item may include a […] liquid level…”; see also [0097], which teaches the determination of a quantity of liquid.).
With regards to claim 12, the device of claim 1 is obvious over Davis et al in view of Klumph et al and further in view of Wasson et al.
Neither Davis et al nor Wasson et al explicitly disclose wherein the recognized visual indicators comprise alphanumeric characters.
Klumph et al additionally teaches the claimed “wherein the recognized visual indicators comprise alphanumeric characters” has been read on the taught ([0091], “…optical character recognition (OCR) operations may be performed to determine a lot number (LOT) and an expiration date (EXP) for the vial from the captured images.”; character recognition reads on the visual indicators comprising alphanumeric characters.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Davis et al in view of Klumph et al in view of Wasson et al with the alphanumeric characters as taught by Klumph et al. According to MPEP 2143(I)(C), use of a known technique to improve similar devices in the same way may be prima facie obvious. In the case of the instant invention, the prior art of Davis et al in view Klumph et al in view of Wasson et al contains a “base” device of a fluid processing system including visual indicators, upon which the claimed invention can be seen as an “improvement.” The prior art of Klumph et al contains a “comparable” device that has been improved in the same way as the claimed invention, with alphanumeric visual indicators. One of ordinary skill in the art could have applied the known indicator improvement in the same way to the base device, for the predictable result of an improved system which can identify common factory labels including letters and numbers.
With regards to claim 13, the device of claim 1 is obvious over Davis et al in view of Klumph et al and further in view of Wasson et al.
Davis et al additionally teaches;
The claimed “a deck having source locations and destination locations” has been read on the taught ([0032], “…the deck 104 may include a plurality of platforms. Each platform may have one or more recesses shaped and sized to receive a sample, reagent, vias, and/or other labware.”);
The claimed “a pipettor configured to aspirate liquid from source locations on the deck and to dispense the aspirated liquids to destination locations on the deck” has been read on the taught ([0032], “…the deck housing 102 may also house a controllable pipettor, gripper, one or more robotic arms, and/or other controllable processing equipment configured for processing samples arranged on the deck 104. In some embodiments, such pipettor, gripper, robotic arm, or other processing equipment may be automated or partially automated to perform designated methods, analyses, or processes.”);
The claimed “wherein the programmed protocol further specifies a destination location for the corresponding reagent in each of the plurality of reagent vessels loaded into the vessel holder, and wherein the processor is further configured for each of the plurality of reagent vessels loaded into the vessel holder, to: determine the destination location specified for the identified reagent in the programmed protocol; direct the pipettor to aspirate a volume of liquid from the reagent vessel in the vessel holder, and direct the pipettor to dispense the aspirated volume at the determined destination location for the identified reagent” has been read on the taught ([0032], “…such pipettor, gripper, robotic arm, or other processing equipment may be automated or partially automated to perform designated methods, analyses, or processes.”; One of ordinary skill in the art will recognize that computer-controlled automated fluid processing equipment would be configured as claimed.)
With regards to claim 14, the device of claim 13 is obvious over Davis et al in view of Klumph et al and further in view of Wasson et al.
Davis et al broadly teaches the use of an automated pipetting system, but Davis et al in view of Klumph et al does not explicitly disclose “wherein the processor is further configured, for each reagent vessel loaded into the vessel holder, to direct the pipettor to aspirate the volume of liquid from the reagent vessel and to dispense the aspirated volume at the determined destination location regardless of the position in the vessel holder into which the reagent vessel has been loaded.”
Wasson et al further teaches teaches;
The claimed “wherein the processor is further configured, for each reagent vessel loaded into the vessel holder, to direct the pipettor to aspirate the volume of liquid from the reagent vessel and to dispense the aspirated volume at the determined destination location regardless of the position in the vessel holder into which the reagent vessel has been loaded” has been read on the taught ([1388], “The controller may, based on the signals from the sensors, effect a change in a component or maintain the state of a unit. For example, the controller […] determine a protocol to run on a particular assay sample, move a vessel and/or tip, or dispense and/or aspirate a sample.”; [1200], “The location of each reagent unit may be tracked. A reagent unit may be individually selected to receive and/or provide a fluid.”; The controller which determines a protocol based on signals form sensors to dispense and/or aspirate a sample reads on instructions to prepare the sample by directing the pipettor to move, aspirate, and dispense a given reagent. The reagent unit having a tracked location which may be individually selected reads on the pipettor aspirating a volume of liquid regardless of a location of the reagent vessel in the tube holder.).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the fluid handling system as taught by Davis et al in view of Klumph with the processor configured to direct a pipettor as taught by Wasson et al. According to MPEP 2143(I)(C), use of a known technique to improve similar devices in the same way may be prima facie obvious. In the case of the instant invention, the prior art of Davis et al in view Klumph et al contains a “base” device of an automated pipetting system, upon which the claimed invention can be seen as an “improvement.” The prior art of Wasson et al contains a “comparable” device that has been improved in the same way as the claimed invention, with tracked locations of various vessels. One of ordinary skill in the art could have applied the known indicator improvement in the same way to the base device, for the predictable result of an improved system which can pipette automatically regardless of the deck set-up.
With regards to claim 15, the device of claim 1 is obvious over Davis et al in view of Klumph et al and further in view of Wasson et al.
Davis et al additionally teaches the claimed “wherein the processor is further configured to determine from images of the vessel holder, if caps have been removed from the reagent vessels, and to provide an alarm if a cap has not been removed from a reagent vessel” as read on the taught ([0073], “…a neural network may be used to determine […] whether the RV has a lid and/or seal in accordance with a particular deck setup configuration.”; [0076], “If it is determined that the item 504a is the correct box but contains a lid or other covering, an error may be recorded to alert an operator to remove the lid for processing.”).
With regards to claim 16, Davis et al teaches;
The claimed “A fluid handling system” has been read on the taught ([0007], “…the laboratory workstation may include a fluid handling system.”);
The claimed “a processor” has been read on the taught ([0007], “The workstation may further include a processor…”);
The claimed “a deck having source locations and destination locations” has been read on the taught ([0032], “…the deck 104 may include a plurality of platforms. Each platform may have one or more recesses shaped and sized to receive a sample, reagent, vias, and/or other labware.”);
The claimed “a tube holder located on the deck and configured to receive a reagent vessel” has been read on the taught ([0032], “The deck 104 may include a platform or surface configured for receiving samples, reagents, vials, and/or other labware.”; [0007], “The labware item may include a […] carousel…”; A carousel reads on a tube holder configured to receive a reagent vessel.);
The claimed “a reagent vessel having a label with visual indicators of identifying features” has been read on the taught ([0061], “…the verification module may be configured to read barcodes, quick response (QR) codes, or other codes, labels, or identifiers in an image…”; Labels or identifiers read on the reagent vessels having visual indicators. See also [0081] teaching a reaction vessel with a barcode indicator.);
The claimed “an imaging device” configured to create an image of the label on the reagent vessel in the tube holder” has been read on the taught ([0007], “The workstation may additionally include an imaging device configured to monitor the deck of the laboratory workstation by creating one or more images of the deck.”);
The claimed “a pipettor configured to aspirate liquid from source locations on the deck and to dispense the aspirated liquids to destination locations on the deck” has been read on the taught ([0032], “…the deck housing 102 may also house a controllable pipettor, gripper, one or more robotic arms, and/or other controllable processing equipment configured for processing samples arranged on the deck 104. In some embodiments, such pipettor, gripper, robotic arm, or other processing equipment may be automated or partially automated to perform designated methods, analyses, or processes.”);
The claimed “a non-transitory, computer-readable storage medium including a programmed protocol, the programmed protocol specifying source locations and destination locations for different reagents on the deck, and comprising computer readable instructions that cause the fluid handling system to prepare the sample” has been read on the taught ([0007], “…the programmed protocol may call for a plurality of items of labware to be arranged on the deck…”; [0041], “…the database 110 may be a remote or local storage device. The database 110 may store programmed protocols, each associated with a particular deck setup configuration.”);
The claimed instructions to “capture a plurality of images of the plurality of reagent vessels using the imaging device; recognizing the visual indicators in the plurality of images of the label and to identify a reagent in the reagent vessel based on the recognized visual indicators; determining the destination location specified for the identified reagent in the programmed protocol ([0009], “The method may additionally include monitoring the deck by creating one or more images of the deck using an imaging device. The method may further include, from the one or more images of the deck, identifying an item of labware loaded onto the deck by an operator. The method may include, from the one or more images of the deck, determining whether the item of labware is arranged on the deck in accordance with the programmed protocol…”).
However, Davis et al does not explicitly disclose a motor configured to rotate the tube holder; instructions to prepare the sample by rotating the tube holder and reagent vessel using the motor; directing the pipettor to aspirate a volume of liquid from the reagent vessel regardless of a location of the reagent vessel in the tube holder; aspirating, using the pipettor, the volume of liquid from the reagent vessel at an actual location for that reagent vessel; and directing the pipettor to dispense the aspirated volume at the determined destination location for the identified reagent.
In the analogous art of fluid handling systems including imaging devices, Klumph et al teaches;
The claimed “a vessel holder comprising a plurality of pedestals including a pedestal” has been read on the taught ([0004], “…a compounder system is provided that includes a vial tray having a vial opening for receiving a vial containing a drug…”);
The claimed “a motor configured to rotate the pedestal” has been read on the taught ([0004], “…a second motor configured to rotate the vial while the camera captures images of a label on the vial…”);
The claimed “instructions that cause the fluid handling system to rotate the pedestal and reagent vessel using the motor; capture a plurality of images of the plurality of reagent vessels using the imaging device” has been read on the taught ([0005], “a method is provided that includes […] rotating the vial while the vial is in the vial tray at the imaging location; capturing at least one image of the label while rotating the vial; and determining at least one of a lot number and an expiration date from the at least one image.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device including a carousel as taught by Davis et al with the motor configured to rotate and instructions including rotation as taught by Klumph et al, for the benefit of an improved system which can scan a vial label regardless of the initial orientation of the vial (Klumph et al, [0073], “…the inserted vial 18 may be rotated within its position in vial tray 22 using a vial rotation motor 2602 to allow the vial label to be scanned.”).
However, Davis et al in view of Klumph et al does not explicitly disclose instructions directing the pipettor to aspirate a volume of liquid from the reagent vessel regardless of a location of the reagent vessel in the tube holder; aspirating, using the pipettor, the volume of liquid from the reagent vessel at an actual location for that reagent vessel; and directing the pipettor to dispense the aspirated volume at the determined destination location for the identified reagent.
In the analogous art of automated fluid handling systems, Wasson et al teaches;
The claimed “instructions that cause the fluid handling system to prepare the sample by; […] directing the pipettor to aspirate a volume of liquid from the reagent vessel regardless of a location of the reagent vessel in the tube holder; aspirating, using the pipettor, the volume of liquid from the reagent vessel at an actual location for that reagent vessel; and directing the pipettor to dispense the aspirated volume at the determined destination location for the identified reagent” has been read on the taught (([1388], “The controller may, based on the signals from the sensors, effect a change in a component or maintain the state of a unit. For example, the controller […] determine a protocol to run on a particular assay sample, move a vessel and/or tip, or dispense and/or aspirate a sample.”; [1200], “The location of each reagent unit may be tracked. A reagent unit may be individually selected to receive and/or provide a fluid.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the fluid handling system as taught by Davis et al in view of Klumph with the processor configured to direct a pipettor as taught by Wasson et al. According to MPEP 2143(I)(C), use of a known technique to improve similar devices in the same way may be prima facie obvious. In the case of the instant invention, the prior art of Davis et al in view Klumph et al contains a “base” device of an automated pipetting system, upon which the claimed invention can be seen as an “improvement.” The prior art of Wasson et al contains a “comparable” device that has been improved in the same way as the claimed invention, with tracked locations of various vessels. One of ordinary skill in the art could have applied the known indicator improvement in the same way to the base device, for the predictable result of an improved system which can pipette automatically regardless of the deck set-up.
With regards to claim 17, Davis et al teaches;
The claimed “programming a protocol for preparing a sample into a controller of the fluid handling system” has been read on the taught ([0041], “An operator may access the database 110 to select among the stored protocols for a particular method or process the operator wishes to run.”; [0007], “…a laboratory workstation for preparing a sample according to a programmed protocol.”);
The claimed “loading multiple reagent vessels into a vessel holder of the fluid handling system” has been read on the taught ([0064], “…a technician or other operator loads components onto a deck…”);
The claimed “capturing a plurality of images of the multiple reagent vessels using the imaging device; imaging individual labels of the multiple reagent vessels with an imaging device to produce label images” has been read on the taught ([0064], “…an imaging device of the present disclosure may capture images of the deck, such that a position and/or identification of the components may be verified from the imaging.”; [0061], “…the verification module may be configured to […] labels, or identifiers in an image.”);
The claimed “comparing information in the label images to identification information located in a database in communication with the controller” has been read on the taught ([0061], “A barcode reading library, such as ZBar for example, may be used to scan images for barcodes or other identifiers.”; the library reads on a database.);
The claimed “determining if appropriate reagents have been leaded into the vessel holder to perform the protocol” has been read on the taught ([0008], “…the processor may be further configured to determine whether the loaded item of labware has been loaded on the deck in accordance with the programmed protocol.”);
The claimed “updating the protocol to access the multiple reagent vessels regardless of a location of each reagent vessel in the vessel holder” has been read on the taught ([0079], “…deck setup instructions may be dynamically modified in response to component verification…”; [0043], “…the instructions module may be configured for generating the programmed protocol.”; Generating the programmed protocol reads on updating the programmed protocol to direct the fluid handling system.).
However, Davis et al does not explicitly disclose wherein the method comprises rotating the multiple reagent vessels, using a motor; and aspirating a volume of liquid from at least one reagent vessel at an actual location for the at least one reagent vessel.
In the analogous art of fluid handling systems including imaging devices, Klumph et al teaches;
The claimed “rotating the multiple reagent vessels, using a motor” has been read on the taught (([0004], “…a second motor configured to rotate the vial while the camera captures images of a label on the vial…”);
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method as taught by Davis et al with the rotations step as taught by Klumph et al, for the benefit of an improved method which can scan a vial label regardless of the initial orientation of the vial (Klumph et al, [0073], “…the inserted vial 18 may be rotated within its position in vial tray 22 using a vial rotation motor 2602 to allow the vial label to be scanned.”).
However, Davis et al in view of Klumph et al does not explicitly disclose wherein the method comprises aspirating a volume of liquid from at least one reagent vessel at an actual location for the at least one reagent vessel.
In the analogous art of automated fluid handling systems, Wasson et al teaches;
The claimed “aspirating a volume of liquid from at least one reagent vessel at an actual location for the at least one reagent vessel” has been read on the taught ([1388], “The controller may, based on the signals from the sensors, effect a change in a component or maintain the state of a unit. For example, the controller […] determine a protocol to run on a particular assay sample, move a vessel and/or tip, or dispense and/or aspirate a sample.”; [1200], “The location of each reagent unit may be tracked. A reagent unit may be individually selected to receive and/or provide a fluid.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method as taught by Davis et al in view of Klumph with the aspirating step as taught by Wasson et al. According to MPEP 2143(I)(C), use of a known technique to improve similar methods in the same way may be prima facie obvious. In the case of the instant invention, the prior art of Davis et al in view Klumph et al contains a “base” method for preparing a sample upon which the claimed invention can be seen as an “improvement.” The prior art of Wasson et al contains a “method” device that has been improved in the same way as the claimed invention, with aspiration of a sample from tracked locations of various vessels. One of ordinary skill in the art could have applied the known indicator improvement in the same way to the base device, for the predictable result of an improved method which can pipette automatically regardless of the deck set-up.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Davis et al (US 20220276274 A1) in view of Klumph et al (WO 2017095702 A1) in view of Wasson et al (US 20160124009 A1, cited on the IDS filed 25 April 2025) as applied to claim 4, and further in view of Barbieri et al (US 20070291143 A1).
With regards to claim 5, the device of claim 4 is obvious over Davis et al in view of Klumph et al and further in view of Wasson et al.
However, this combination does not explicitly disclose wherein the processor is further configured to calibrate a rotational speed of individual reagent vessels in the vessel holder using a geometric calibration label.
In the analogous art of image processing methods, Barbieri et al teaches;
The claimed “wherein the processor is further configured to calibrate a rotational speed of individual reagent vessels in the vessel holder using a geometric calibration label” has been read on the taught ([0057], “The rotation of the object may be determined by […] a sensor positioned outside the object, for instance a fixed separate camera following the object, wherein the object is provided with a marking, and the sensor measured the rotational speed by following the movement of this marking.”).
While Barbieri does not teach a specifically geometric calibration label, MPEP 2144.04(IV)(B) teaches that changes in shape may be prima facie obvious—see In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid handling system including a processor as taught by Davis et al in view of Klumph et al in view of Wasson et al with the processor configured to calibrate a rotation speed using a label as taught by Barbieri et al. According to MPEP 2143(D), applying a known technique to a known device ready for improvement to yield predictable results may be prima facie obvious. In the case of the instant invention, the prior art contains a rotating sample holder, vessels with labels, and an imaging device. The use of the imaging device to calibrate rotational speeds can be seen as an “improvement”, and the prior art of Barbieri et al contains the known technique of using a camera to calibrate rotational speeds, which is applicable to the base device. One of ordinary skill in the art would have recognized that applying the technique yields a predictable result of an integrated system that can control rotational speeds using feedback from a camera. This results in an improved system which does not require magnetic sensors or other tachometers to measure the speed of the rotating sample holder.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/ALISON CLAIRE GERHARD/ Examiner, Art Unit 1797 /LYLE ALEXANDER/ Supervisory Patent Examiner, Art Unit 1797
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