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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 14 January 2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09 December 2025 and 16 January 2026 were filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Applicant's arguments filed 14 January 2026 regarding the rejections under 35 U.S.C. 101 have been fully considered but they are not persuasive.
Applicant’s arguments regarding Step 2A Prong 1 hinge on the claim that a human mind could not recognize visual indicators, identify a reagent, or determine if a reagent matched a specified list. While the claimed system uses computer components to perform these tasks, nothing in the claim language or the nature of the task as claimed prevents it from being performed in the human mind. Applicant recites In re Bilski in support of their interpretation. However, the device represented in the independent claim is not recited in sufficient detail to be “a particular machine or apparatus” and all recited functions can be performed on a general purpose computer. Unlike calculating the position of a GPS satellite, the human mind is capable of recognizing a visual indicator in a picture and updating a list.
The examiner appreciates applicant’s arguments regarding recognizing the indicator while the vial is being rotated. However, this is not commensurate with the scope of the claims. The broadest reasonable interpretation of the instructions, given the open language of the claims, allows the system to rotate the pedestal, stop the pedestal, and then capture an image. As the claim language encompasses this interpretation, arguments relying on a human mind being unable to recognize an indicator in an image of an actively rotating vial are not persuasive.
Regarding applicant’s arguments that the judicial exception is integrated by updating the programmed protocol, this is held to be insignificant post-solution activity, or akin to instructions to merely apply the judicial exception. Please see the 101 rejection below for a more detailed discussion on the integration of the judicial exception.
Regarding applicant’s arguments that the elements of the claims are not well-understood, routine, and conventional, please see the updated prior art rejections of record. Applicant’s arguments that the ordered combination are unique are not entirely persuasive. Ultimately, the system moves a component into view, checks the position of the component, and then double-checks a list. This process is well-understood, routine, and conventional in the art of inventory management.
The examiner appreciates the change of language from “adapt” to “update.” The examiner believes that “updating” does not recite a mental process, and the 101 rejections have been updated accordingly.
The examiner recognizes applicant’s claim that Wasson et al does not teach a rotating pedestal, though the examiner holds that the current claim language could be read on something such as a centrifuge (which is disclose in Wasson et al). In the interest of compact prosecution and in light of the amendments to the claims, a new grounds of rejection has been brought forward under Davis et al in view of Klumph et al.
Status of Claims
Applicant's amendments to the claims filed 14 January 2026 have been entered. Applicant's remarks filed 14 January 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 cancelled.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 1 is directed to the mental processes grouping of abstract ideas. Claim 1 recites an apparatus.
The limitations of “recognize the visual indicators” in line 21, “determine if appropriate reagents have been loaded into the vessel holder” in line 23, and “determine if a loaded location of the reagent vessel […] corresponds to an expected location for that reagent vessel…” in line 25 are processes that, under their broadest reasonable interpretation, cover performance of the limitations in the mind but for the recitation of generic computer components. Aside from reciting “computer readable instructions that cause the fluid handling system to”, nothing in the claim element precludes these limitations from practically being performed in the mind. For example, but for the “computer readable instructions” language, “recognize” in the context of this claim encompasses an individual visually reviewing the visual indicator in the image and identifying the reagent. According to a similar analysis, “determine” in the context of this claim encompasses an individual visually reviewing the identified image and checking that reagents have been loaded according to a protocol.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “mental processes” grouping of abstract ideas. Accordingly, the claim recites abstract ideas.
The judicial exception is not integrated into a practical application. Regarding the abstract ideas, the recognizing and determining are performed by a processor, which is a general purpose computer and not a particular machine. While the claim recites that the computer readable instructions “cause the fluid handling system to […] recognize [… and] determine…” no details in the claim or specification indicate that the recognizing and determining are applied using more than conventional computer functions. Performing the abstract ideas on a general-purpose computer does not integrate the abstract idea into a practical application; please see MPEP 2016.05(b).
Regarding the limitation of “update the programmed protocol to direct the fluid handling system to access that reagent vessel at an actual location for that reagent vessel,” this is an application of the idea that is not sufficient to amount to a particular practical application. A processor which updates its protocol amounts to “merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea,” as recited by MPEP 2106.04(d). See additional details on using a computer as a tool to perform an abstract idea as discussed in MPEP 2106.05(f). Updating a programmed protocol is not an improvement in the functioning of a computer, and cannot be considered a particular practical application of the abstract idea under those grounds—please see MPEP 2106.04(d) section III.
The addition of generic computer components through the claim limitations of an “imaging device”, “a non-transitory computer-readable storage medium”, and “a processor” do not integrate the abstract idea into a particular machine. The additional machine elements of “a vessel holder comprising a plurality of pedestals” and “a motor configured to rotate the pedestal” are general elements of a machine for fluid handling, and neither the specification nor the claim outlines details of these elements which rely on the abstract ideas for improvements over other methods (i.e., having a human operator verify the location of the reagents for the pipetting system). The limitation of “updating the programmed protocol to direct the fluid handling system to access that reagent vessel” does not “effect a transformation of reduction of a particular article to a different state or thing” as outlined in MPEP 2106.05(c).
Accordingly, the examiner holds that the limitation “updating the programmed protocol to direct the fluid handling system to access that reagent vessel at an actual location for that reagent vessel” do not amount to more that “a recitation of the words “apply it” (or an equivalent) or are more than mere instructions to implement an abstract idea or other exception on a computer” as outlined in MPEP 2106.05(f). As such, claim 1 does not integrate the abstract ideas of “recognizing” and “determining” into a particular practical application.
The additional elements of the claim including a reagent kit with reagent vessels containing liquid reagents, a non-transitory computer-readable storage medium including a programmed protocol with a list of reagents, a vessel holder configured to receive the plurality of reagent vessels, and an imaging device configure to create an image of each of the plurality of reagent vessel are all elements used in data-gathering later used in the recognizing and determining. Data gathering to be used in the abstract idea is insignificant extra-solution activity, and is not a particular practical application; please see MPEP 2160.05(g). These elements are additionally well-understood, routine, and conventional in the art of automated fluid handling apparatuses; please see the prior art rejection of claim 1.
Claims 3 – 8 and 12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The limitations of these claims provide additional details to the structures of the machine, but do not recite any actions taken after the “adapting” step of claim 1. Rather, they are elements used in data-gathering later used in the recognizing and determining, and therefore cannot be considered part of a particular practical application. These elements are well-understood, routine, and conventional in the arts of automated laboratory systems and image processing; please see the prior art rejections of these claims.
Claims 9 and 10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The limitations of these claims provide further actions of the processor. However, comparing visual indicators amounts to data-gathering that is later used in the determining step, and cannot be considered part of a particular practical application. Additionally, the limitations of “compare visual indicators in the database to decipher” and “compare the deciphered visual indicators” recite the abstract mental idea of “comparing,” which appears to be an evaluation or judgment. The limitation of “comparing” follows the analysis of “determining” as discussed in the 101 rejection of claim 1.
Claim 11 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The limitations of these claims provide further actions of the fluid handling system and the processor. However, these limitations are not integrated into the “recognizing” or “determining” steps as recited in claim 1, and as such do not integrate these judicial exceptions into a particular practical application. Additionally, the limitation of “determining” is an abstract idea, following the analysis in the rejection of claim 1.
Claim 13 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The additional machine elements of “a deck”, “a tube holder located on the deck” and “a pipettor” are general elements of a machine for fluid handling, and neither the specification nor the claim outlines details of these elements which rely on the abstract ideas for improvements over other methods (i.e., having a human operator verify the location of the reagents for the pipetting system). The limitation of “directing a pipettor” does not “effect a transformation or reduction of a particular article to a different state or thing” as outlined in MPEP 2106.05(c).
Accordingly, the examiner holds that the limitations of “directing the pipettor to aspirate…” and “directing the pipettor to dispense…” do not amount to more than, “a recitation of the words “apply it” (or an equivalent) or are more than mere instructions to implement an abstract idea or other exception on a computer” as outlined in MPEP 2106.05(f). As such, claim 13 does not integrate the abstract ideas of “recognizing” and “determining” into a particular practical application.
These additional elements are well-understood, routine, and conventional in the art; please see the prior art rejections of claim 13.
Claim 14 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more, following the analysis claim 13’s limitation of “directing the pipettor”. Additionally, if the system is configured to aspirate and dispense regardless of the position of a reagent vessel, then the broadest reasonable interpretation of this language means that the “determining” and “adapting” steps of claim 1 are not integrated into a practical application. Nothing is done with the information handled in the determining and adapting steps, as the pipettor is directed to act regardless of the location information stored in the protocol.
Claim 15 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The limitation of claim 15 provides further actions of the processor. However, this limitation is not integrated into the “recognizing,” “determining,” or “adapting” steps as recited in claim 1, and as such do not integrate these judicial exceptions into a particular practical application. Additionally, claim 15 recites the abstract idea of “determining,” which is read to be a mental process following the analysis of claim 1. The processor being configured to provide an alarm is not sufficient to integrate the abstract idea into something more. The alarm may be considered insignificant post-solution activity—see Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978).
Claim 16 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 16 is directed to the mental processes grouping of abstract ideas. Claim 16 recites an apparatus.
The limitations of “recognizing the visual indicators” in line 19 and “determining the destination location” in line 21 are processes that, under their broadest reasonable interpretation, covers performance of the limitations in the mind but for the recitation of generic computer components. Aside from reciting “computer readable instructions that cause the fluid handling system to prepare the sample by…”, nothing in the claim element precludes these limitations from practically being performed in the mind. For example, but for the “computer readable instructions,” “recognizing” in the context of this claim encompasses an individual visually reviewing the visual indicator in the image and identifying the reagent. According to a similar analysis, “determining” in the context of this claim encompasses an individual visually reviewing the identified image and checking that reagents have been loaded according to a protocol.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “mental processes” grouping of abstract ideas. Accordingly, the claim recites abstract ideas.
This judicial exception is not integrated into a practical application. Regarding the abstract ideas, the recognizing and determining are performed by a computer/processor, which is a general purpose computer and not a particular machine. No details in the claim or specification indicate that the recognizing and determining are applied using more than conventional computer functions. Performing the abstract ideas on a general-purpose computer does not integrate the abstract idea into a practical application; please see MPEP 2016.05(b).
Regarding the limitations of “directing the pipettor”, these are applications of the idea that are not sufficient to amount to a particular practical application. A processor which directs a pipettor amounts to “merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea”, as recited by MPEP 2106.04(d). See additional details on using a computer as a tool to perform an abstract idea as discussed in MPEP § 2106.05(f). “Directing the pipettor” is not a limitation directed to an improvement in the functioning of a computer or an improvement to another technology, and cannot be considered a particular practical application of the abstract idea under those grounds—please see MPEP 2106.04(d) section III.
The addition of generic computer components through the claim limitations of an “imaging device”, “a non-transitory computer-readable storage medium”, and “a processor” do not integrate the abstract idea into a particular machine. The additional machine elements of “a deck”, “a tube holder located on the deck” and “a pipettor” are general elements of a machine for fluid handling, and neither the specification nor the claim outlines details of these elements which rely on the abstract ideas for improvements over other methods (i.e., having a human operator verify the location of the reagents for the pipetting system). The limitation of “directing a pipettor” does not “effect a transformation or reduction of a particular article to a different state or thing” as outlined in 2106.05(c).
Accordingly, the examiner holds that the limitations of “directing the pipettor to aspirate…” and “directing the pipettor to dispense…” do not amount to more than, “a recitation of the words “apply it” (or an equivalent) or are more than mere instructions to implement an abstract idea or other exception on a computer” as outlined in MPEP 2106.05(f). As such, claim 16 does not integrate the abstract ideas of “recognizing” and “determining” into a particular practical application.
Additionally, if the system is configured to aspirate and dispense regardless of the position of a reagent vessel, then the broadest reasonable interpretation of this language means that the “recognizing” and “determining” steps of claim 16 are not integrated into a practical application. Nothing is done with the information handled in the determining and adapting steps, as the pipettor is directed to act regardless of the location information stored in the protocol.
Claim 16 does not recite any elements which are significantly more than the abstract idea. The additional elements of the claim including a deck, a tube holder located on the deck, a non-transitory computer-readable storage medium, and an imaging device configure to create an image are all elements used in data-gathering later used in the recognizing and determining. Data gathering to be used in the abstract idea is insignificant extra-solution activity, and is not a particular practical application; please see MPEP 2160.05(g). These elements are additionally well-understood, routine, and conventional in the art; please see the prior art rejection of claim 16.
Accordingly, the claim is directed to the mental processes grouping of abstract ideas, reciting the mental processes of “recognizing” and “determining.” The abstract ideas have not been integrated into a particular practical application, and the claim does not recite additional elements which are significantly more than the abstract idea. Therefore, the claim is ineligible.
Claim 17 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 17 is directed to the mental processes grouping of abstract ideas. Claim 17 recites a method.
The limitations of “comparing information” in line 10 and “determining if appropriate reagents have been loaded” in line 12 are processes that, under their broadest reasonable interpretation, cover performance of the limitations in the mind but for the recitation of generic computer components. Aside from reciting “a controller” nothing in the claim element precludes these limitations from practically being performed in the mind. For example, but for the “with the controller” language, “comparing” in the context of this claim encompasses an individual visually reviewing the visual indicator in the image and checking the labels. According to a similar analysis, “determining” in the context of this claim encompasses an individual visually reviewing the identified image and checking that reagents have been loaded according to a protocol.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “mental processes” grouping of abstract ideas. Accordingly, the claim recites abstract ideas.
This judicial exception is not integrated into a practical application because the recognizing and determining steps are not used, as the vessels are accessed regardless of the location of the reagent. The recognizing is performed by a computer/processor, which is a general purpose computer and not a particular machine. No details in the claim or specification indicate that the recognizing is applied using more than conventional computer functions. Performing the abstract ideas on a general-purpose computer does not integrate the abstract idea into a practical application; please see MPEP 2016.05(b).
The additional elements of the claim including programming a protocol into a fluid handling system, loading reagent vessels into a vessel holder of the fluid handling system, and imaging labels with an imaging device are all elements used in data-gathering later used in the comparing and determining. Data gathering to be used in the abstract idea is insignificant extra-solution activity, and is not a particular practical application; please see MPEP 2160.05(g). These elements are additionally well-understood, routine, and conventional in the art of automated fluid handling apparatuses; please see the prior art rejection of claim 17.
Accordingly, the claim is directed to the mental processes grouping of abstract ideas, reciting the mental processes of “recognizing” and “determining.” The abstract ideas have not been integrated into a particular practical application, and the claim does not recite additional elements which are significantly more than the abstract idea. Therefore, the claim is ineligible.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3, 4, 6 – 13, 15, and 17 are rejected under 35 U.S.C. 103 as being obvious over Davis et al (US 20220276274 A1) in view of Klumph et al (WO 2017095702 A1).
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.).
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.
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.”).
With regards to claim 3, the device of claim 1 is obvious over Davis et al in view of Klumph et al.
Davis et al does not 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 with the device wherein each of the reagent vessels is rotatable along a central axis of the reagent vessel as taught by KIumph 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.
Davis et al does not 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.
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.
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.
Davis et al does not 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 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.
Davis et al does not 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 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.
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.
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.
Davis et al does not 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 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 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.
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 15, the device of claim 1 is obvious over Davis et al in view of Klumph 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 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.
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.”).
Claims 14 and 16 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) as applied to claim 13 above, and further in view of Wasson et al (US 20160124009 A1, cited on the IDS filed 25 April 2025.).
With regards to claim 14, the device of claim 13 is obvious over Davis et al in view of Klumph 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.”
In the analogous art of automated fluid handling systems, Wasson et al 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 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; 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; 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; 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.
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) 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.
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 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Sherrill et al (US 20200363439 A1) teaches an imaging system for verifying the deck of a fluid handling device.
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/ALISON CLAIRE GERHARD/Examiner, Art Unit 1797 /LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797