DETAILED ACTION
In application filed on 05/26/2023, Claims 1-20 are pending. The claim set submitted on 03/29/2026 is considered because this is the most recent claim set. Claims 1-10 and 20 are considered in the current office action.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/13/2023 and 05/29/2024 are in compliance with the provisions of 37 CFR 1.17(p). Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 12/12/2025 is acknowledged. Claims 11-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/12/2025.
Group I, Claims 1-10 and 20 are considered on the merits below.
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 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over McKeon et al (US20100086919A1, submitted in IDS, 02/24/2026) in view of Tisone et al. (US20130150266A1).
Regarding Claim 1, McKeon teaches a micro fluidic system comprising:
a dispense head (See Annotated Fig. 3) comprising:
a first dispenser (referred to as one or more inlet modules [Para 0114; Fig. 3]) to dispense a first biological cell type (See Para 0115…a droplet encapsulating one or more cells, thereby teaching “a first biological cell type”; See Para 0130…a plurality of B cells expressing a desired immunoglobulin) and a second dispenser (referred to as one or more inlet modules [Para 0114; Fig. 3]) to dispense a second biological cell type (See Para 0115…a droplet encapsulating one or more cells, thereby teaching “a second biological cell type”; See Para 0130… a plurality of immortalized cells (e.g., myeloma cells));
a first dispenser channel (referred to as a first inlet channel [Para 0130]) to load cells (See Para 0103… a plurality of B cells expressing a desired immunoglobulin, through a first inlet channel) into a first cell staging chamber (See Annotated Fig. 1) to be dispensed (See Para 0122… where the dispersed phase fluid is immiscible with the continuous phase fluid) by the first dispenser channel (referred to as one or more inlet modules [Para 0114; Fig. 3]), and a second dispenser channel (referred to as a second inlet channel [Para 0130]) to load cells (See Para 0130…a plurality of immortalized cells (e.g., myeloma cells) through a second inlet channel) into a second cell staging chamber (See Annotated Fig. 1) to be dispensed See Para 0122… where the dispersed phase fluid is immiscible with the continuous phase fluid) by the second dispenser(referred to as one or more inlet modules [Para 0114; Fig. 3]); and
one or more sensing circuits (referred to as detection module [Para 0114; Fig.3]) to detect single cells (See Para 0114…a detection module including a detection apparatus for evaluating the contents and/or characteristics of the coalesced droplets produced in the coalescence module; See Para 0122…interrogating the nanoreactor for a predetermined characteristic of the cells (such as fluorescence) within a detection module) in the first dispenser channel (referred to as one or more inlet modules [Para 0114; Fig. 3]) and in the second dispenser channel (referred to as a second inlet channel [Para 0130]); and
microfluidic control (See Para 0020…wherein at least one of the steps 1), 2), or 3) is performed under microfluidic control ;See Para 0106…the term “microfluidic control” refers to the use of a microfluidic system comprising microfluidic channels as defined herein to direct or otherwise control the formation and/or movement of microcapsules (or “droplets”) in order to carry out the methods of the present invention; see Para 0169…other means of control of the microcapsules, in addition to charge, can also be incorporated onto the microfluidic device) to use the dispense head (See Annotated Fig. 3) to dispense (See Para 0033…Exemplary devices and methods of transferring cells from a collection device to an expansion device), in each individual well of a multiwell plate (See Para 0147…Alternatively, the microfluidic devices may have a cell expansion module, in which each of collected immortalized antibody-producing cells (e.g., hybridoma cells) are placed in a separate well; See Para 0148…The cell expansion device 120 comprises a structure 121 defining a plurality of wells 122 with adjacent), an individual first cell (See Para 0147… each of collected immortalized antibody-producing cells (e.g., hybridoma cells) are placed in a separate well; See Para 0128… each B cell expressing a desired immunoglobulin as a cell-surface bound immunoglobulin is placed a microtiter well, together with the requisite number of immortalized cells (e.g., myeloma cells)) from the first cell staging chamber (See Annotated Fig. 1) and an individual second cell (See Para 0128…is placed a microtiter well, together with the requisite number of immortalized cells (e.g., myeloma cells; See Para 0147… each of collected immortalized antibody-producing cells (e.g., hybridoma cells;) are placed in a separate well) from the second dispenser cell staging chamber (See Annotated Fig. 1).
McKeon does not explicitly teach “a controller”.
In the analogous art of a quantitative cell dispensing apparatus using liquid droplet manipulation, for quantitatively dispensing cells from hydrophilic suspension containing a plurality of cells, Tisone teaches a controller (See Para 0017… a controller).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the microfluidic system of McKeon in having a controller, as taught by Tisone for the benefit of providing relative motion between the dispensers and the substrate medium on which an array is formed to manufacture a substrate structure for assaying, where in the controller further monitors and controls said dispensers and the relative motion between the dispensers and the array substrate (Tisone, Para 0017-0018), allowing for the provision of novel and improved systems and methods for high speed arraying, hybridization, quantitative development and/or assaying (Tisone, Abstract).
In addition, Claim 1 recites a dispense head, a first dispenser, a first dispenser channel, a second dispenser, a second dispenser channel, one or more sensing circuits and a controller and then recites how these structures function. Claim 1 is an apparatus claim and MPEP 2114 recites that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Regarding Claim 2, the microfluidic system of claim 1 is obvious over McKeon in view of Tisone.
McKeon does not explicitly teach the controller further moving the multiwell plate to a cell incubator after dispensing cells into the individual wells of the multiwell plate.
In the analogous art of a quantitative cell dispensing apparatus using liquid droplet manipulation, for quantitatively dispensing cells from hydrophilic suspension containing a plurality of cells, Tisone teaches that the controller (referred to as controller [Para 0017; Fig. 2C, ref. 514]; See Para 0093… A wide variety of software systems may be used to control and coordinate the operation of the dispensing system 400′; See Para 0132… computer software program is interfaced with the controller 514 (FIG. 2C) to guide dispensing (and/or aspirating) for different modes of operation and different applications) further moving (See Para 0138… the platform 512 are movable in the X, X-Y or X-Y-Z directions to allow for precision dispensing at predetermined locations. Multiple targets 511 may be placed on the table 512,) the multiwell plate (referred to as target substrate [Para 0128; Fig. 2C, ref. 511]; See Para 0124… The target 511 can comprise …such as one or more single-well receptacles, vials or tubes. ) to a cell incubator (referred to as incubation module [Para 0279; Fig. 25, ref. 266]) after dispensing cells (See Para 0113…The BioJet Plus system can be used to dispense buffers, antibodies, enzymes or cells, among others) into the individual wells of the multiwell plate (See Para 0289… dispenses the sample to the test array followed by incubation and reading.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the microfluidic system of McKeon to have the controller further moving the multiwell plate to a cell incubator after dispensing cells into the individual wells of the multiwell plate, as taught by Tisone for the benefit of providing for the hybridization process to take place after application of the sample with master mix (Tisone, Para 0302) allowing for the provision of novel and improved systems and methods for high speed arraying, hybridization, quantitative development and/or assaying (Tisone, Abstract).
In addition, Claim 2 recites a controller and then recites how this structure functions. Claim 2 is an apparatus claim and MPEP 2114 recites that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Regarding Claim 3, the microfluidic system of claim 2 is obvious over McKeon in view of Tisone.
McKeon does not explicitly teach the controller further moving the multiwell plate to a plate reader after moving the multiwell plate to the cell incubator.
In the analogous art of a quantitative cell dispensing apparatus using liquid droplet manipulation, for quantitatively dispensing cells from hydrophilic suspension containing a plurality of cells, Tisone teaches that the controller (referred to as controller [Para 0017; Fig. 2C, ref. 514]; See Para 0093… A wide variety of software systems may be used to control and coordinate the operation of the dispensing system 400′; See Para 0132… computer software program is interfaced with the controller 514 (FIG. 2C) to guide dispensing (and/or aspirating) for different modes of operation and different applications) further moving (See Para 0138… the platform 512 are movable in the X, X-Y or X-Y-Z directions to allow for precision dispensing at predetermined locations. Multiple targets 511 may be placed on the table 512,) the multiwell plate (referred to as target substrate [Para 0128; Fig. 2C, ref. 511]; See Para 0124… The target 511 can comprise …such as one or more single-well receptacles, vials or tubes) to a plate reader (See Para 0289…HYBRIDIZATION/READER MODULE: This module dispenses the sample to the test array followed by incubation and reading) after moving (See Para 0125… to move either the dispenser 528 and/or the carrier platform or table 512 having target 511) the multiwell plate (referred to as target substrate [Para 0128; Fig. 2C, ref. 511]; See Para 0124… The target 511 can comprise …such as one or more single-well receptacles, vials or tubes) to the cell incubator (referred to as incubation module [Para 0279; Fig. 25, ref. 266]) (See Para 0289… dispenses the sample to the test array followed by incubation and reading.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the microfluidic system of McKeon to have the controller further moving the multiwell plate to a plate reader after moving the multiwell plate to the cell incubator, as taught by Tisone for the benefit of having the test array read with the reader module (Tisone, Para 0289) allowing for the provision of novel and improved systems and methods for high speed arraying, hybridization, quantitative development and/or assaying (Tisone, Abstract).
In addition, Claim 3 recites a controller and then recites how this structure functions. Claim 3 is an apparatus claim and MPEP 2114 recites that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Regarding Claim 4, the microfluidic system of claim 1 is obvious over McKeon in view of Tisone.
McKeon does not explicitly teach a stage that is movable by the controller, the stage holding the multiwell plate.
In the analogous art of a quantitative cell dispensing apparatus using liquid droplet manipulation, for quantitatively dispensing cells from hydrophilic suspension containing a plurality of cells, Tisone teaches a stage (referred to as platform [Para 0124; Fig. 2C, ref. 512]) that is movable (See Para 0125… one or more position stepper motors 523, 524 or the like, which are operable to move either the dispenser 528 and/or the carrier platform or table 512 relative to one another in the X, X-Y or X-Y-Z directions; See Para 0135…the platform 512 are movable in the X, X-Y or X-Y-Z directions to allow for precision dispensing at predetermined locations) by the controller (referred to as controller [Para 0017; Fig. 2C, ref. 514]; See Para 0093… A wide variety of software systems may be used to control and coordinate the operation of the dispensing system 400′; See Para 0132… computer software program is interfaced with the controller 514 (FIG. 2C) to guide dispensing (and/or aspirating) for different modes of operation and different applications), the stage (referred to as platform [Para 0124; Fig. 2C, ref. 512]) holding (See Fig. 2c) the multiwell plate (referred to as target substrate [Para 0128; Fig. 2C, ref. 511]; See Para 0124… The target 511 can comprise …such as one or more single-well receptacles, vials or tubes).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the microfluidic system of McKeon to have a stage that is movable by the controller, the stage holding the multiwell plate., as taught by Tisone for the benefit of having the platform 512 to be movable in the X, X-Y or X-Y-Z directions to allow for precision dispensing at predetermined locations (Tisone, Para 0135), allowing for the provision of novel and improved systems and methods for high speed arraying, hybridization, quantitative development and/or assaying (Tisone, Abstract).
In addition, Claim 4 recites a controller and then recites how this structure functions with respect to the stage. Claim 4 is an apparatus claim and MPEP 2114 recites that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Regarding Claim 5, the microfluidic system of claim 1 is obvious over McKeon in view of Tisone.
McKeon does not explicitly teach a plate reader to detect signals from the individual wells of the multiwell plate a predetermined time after dispensing cells into the multiwell plate.
In the analogous art of a quantitative cell dispensing apparatus using liquid droplet manipulation, for quantitatively dispensing cells from hydrophilic suspension containing a plurality of cells, Tisone teaches a plate reader (See Para 0289…HYBRIDIZATION/READER MODULE: This module dispenses the sample to the test array followed by incubation and reading) to detect signals from the individual wells of the multiwell plate (referred to as target substrate [Para 0128; Fig. 2C, ref. 511]; See Para 0124… The target 511 can comprise …such as one or more single-well receptacles, vials or tubes). a predetermined time (See Para 0014… wherein it is desirable to achieve test and read times typically less than 10 minutes.) after dispensing cells (See Para 0124…as shown in FIG. 2C, a substrate or target 511 is mounted on a carrier platform, table or carriage 512 to receive reagent or liquid dispensed from the dispenser 528; See Para 0113…The BioJet Plus system can be used to dispense buffers, antibodies, enzymes or cells, among others.) into the multiwell plate (referred to as target substrate [Para 0128; Fig. 2C, ref. 511]; See Para 0124… The target 511 can comprise …such as one or more single-well receptacles, vials or tubes).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the microfluidic system of McKeon to have a plate reader to detect signals from the individual wells of the multiwell plate a predetermined time after dispensing cells into the multiwell plate, as taught by Tisone for the benefit of having the PCR substrate(s) 80 c to be read at the read, reading or reader station, module or system. This substantially completes the PCR assaying process (Tisone,Para 0312) allowing for the provision of novel and improved systems and methods for high speed arraying, hybridization, quantitative development and/or assaying (Tisone, Abstract).
In addition, Claim 5 recites a plate reader and then recites how the plate reader functions with respect to the multiwall plate. Claim 5 is an apparatus claim and MPEP 2114 recites that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Regarding Claim 6, the microfluidic system of claim 1 is obvious over McKeon in view of Tisone.
McKeon does not teach the controller further to identify one of the individual wells in the multiwell plate for holding cells exhibiting a characteristic, and dispensing contents of the identified individual well into a multiwell receiver plate.
In the analogous art of a quantitative cell dispensing apparatus using liquid droplet manipulation, for quantitatively dispensing cells from hydrophilic suspension containing a plurality of cells, Tisone teaches the controller (referred to as controller [Para 0017; Fig. 2C, ref. 514]; See Para 0093… A wide variety of software systems may be used to control and coordinate the operation of the dispensing system 400′; See Para 0132… computer software program is interfaced with the controller 514 (FIG. 2C) to guide dispensing (and/or aspirating) for different modes of operation and different applications) further to identify one of the individual wells in the multiwell plate (referred to as target substrate [Para 0128; Fig. 2C, ref. 511]; See Para 0124… The target 511 can comprise …such as one or more single-well receptacles, vials or tubes) for holding cells (See Para 0078, 0081…cell transfection arrays; See Para 0007…The arrays can be based on a wide range of sensor molecules that include, but are not limited to, …cells…) exhibiting a characteristic (See Para 0369… quantitate miRNA targets varying from a few copies to millions of copies in the same experiment…different cells, tissue types, and disease states, thereby teaching “a characteristic”), and dispensing contents (See Para 0083… ; spotting onto customized targets, thereby teaching “dispensing contents”) of the identified individual well (See Para 0083… MALDI-MS sample preparation and target loading; accurate dilution series or addition of tiny aliquots of and/or to samples; printing chemical libraries, thereby teaching “identified individual well”) into a multiwell receiver plate (referred to as customized targets, e.g. disc format (round targets or radial designs) [Para 0083]; See Para 0080… High-quality arrays can be desirably loaded, for example, MALDI targets or biosensors, among others, with efficacy).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the microfluidic system of McKeon to have the controller further to identify one of the individual wells in the multiwell plate for holding cells exhibiting a characteristic, and dispensing contents of the identified individual well into a multiwell receiver plate, as taught by Tisone for the benefit of accurately quantitating miRNA targets varying from a few copies to millions of copies in the same experiment. This is an important factor given the wide range of miRNA concentrations within and across different cells, tissue types, and disease states (Tisone, Para 0369) allowing for the provision of novel and improved systems and methods for high speed arraying, hybridization, quantitative development and/or assaying (Tisone, Abstract).
In addition, Claim 6 recites a controller and then recites how the controller functions. Claim 6 is an apparatus claim and MPEP 2114 recites that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Regarding Claim 7, the microfluidic system of claim 1 is obvious over McKeon in view of Tisone.
McKeon does not teach that the controller uses a well plate dispensing element to dispense the contents of the identified individual well into the multiwell receiver plate, the well plate dispensing element comprising at least one of a laser, an air jet nozzle, or a surfactant dispenser.
In the analogous art of a quantitative cell dispensing apparatus using liquid droplet manipulation, for quantitatively dispensing cells from hydrophilic suspension containing a plurality of cells, Tisone teaches that the controller (referred to as controller [Para 0017; Fig. 2C, ref. 514]; See Para 0093… A wide variety of software systems may be used to control and coordinate the operation of the dispensing system 400′; See Para 0132… computer software program is interfaced with the controller 514 (FIG. 2C) to guide dispensing (and/or aspirating) for different modes of operation and different applications) uses a well plate dispensing element (See Para 0115…that uses pressurized air to atomize the fluid passing through the nozzle can be utilized to create a quantitative spray format where a dot or line can be quantitatively generation on a continuous basis; See Para 0117… by adjusting the air pressure or exit orifice size (for an air brush dispenser)) to dispense the contents (See Para 0083… ; spotting onto customized targets, thereby teaching “dispensing contents”) of the identified individual well (See Para 0083… MALDI-MS sample preparation and target loading; accurate dilution series or addition of tiny aliquots of and/or to samples; printing chemical libraries, thereby teaching “identified individual well”) into the multiwell receiver plate(referred to as customized targets, e.g. disc format (round targets or radial designs) [Para 0083]; See Para 0080… High-quality arrays can be desirably loaded, for example, MALDI targets or biosensors, among others, with efficacy), the well plate dispensing element (See Para 0115…that uses pressurized air to atomize the fluid passing through the nozzle can be utilized to create a quantitative spray format where a dot or line can be quantitatively generation on a continuous basis) comprising at least one of a laser, an air jet nozzle, or a surfactant dispenser (See Para 0115…that uses pressurized air to atomize the fluid passing through the nozzle can be utilized to create a quantitative spray format where a dot or line can be quantitatively generation on a continuous basis; See Para 0117… by adjusting the air pressure or exit orifice size (for an air brush dispenser), thereby teaching “air jet nozzle”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the microfluidic system of McKeon to have that the controller uses a well plate dispensing element to dispense the contents of the identified individual well into the multiwell receiver plate, the well plate dispensing element comprising at least one of a laser, an air jet nozzle, or a surfactant dispenser, as taught by Tisone for the benefit of using pressurized air to atomize the fluid passing through the nozzle can be utilized to create a quantitative spray format where a dot or line can be quantitatively generation on a continuous basis (Tisone, Para 0115), allowing for the provision of novel and improved systems and methods for high speed arraying, hybridization, quantitative development and/or assaying (Tisone, Abstract).
In addition, Claim 7 recites a controller and then recites how the controller functions. Claim 7 is an apparatus claim and MPEP 2114 recites that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Regarding Claim 8, the microfluidic system of claim 1 is obvious over McKeon in view of Tisone.
McKeon does not teach a third dispenser to dispense a reagent into the individual wells of the multiwell plate.
In the analogous art of a quantitative cell dispensing apparatus using liquid droplet manipulation, for quantitatively dispensing cells from hydrophilic suspension containing a plurality of cells, Tisone teaches a third dispenser (referred to as one of the three of the dispensers [Fig. 2D, ref. 528) to dispense a reagent (See Para 0124…As shown in FIG. 2C, a substrate or target 511 is mounted on a carrier platform, table or carriage 512 to receive reagent or liquid dispensed from the dispenser 528) into the individual wells of the multiwell plate (referred to as target substrate [Para 0128; Fig. 2C, ref. 511]; See Para 0124… The target 511 can comprise …such as one or more single-well receptacles, vials or tubes).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the microfluidic system of McKeon to have a third dispenser to dispense a reagent into the individual wells of the multiwell plate, as taught by Tisone for the benefit of having target 511 receive reagent or liquid dispensed from the dispenser 528 (Tisone, Para 0124), allowing for the provision of novel and improved systems and methods for high speed arraying, hybridization, quantitative development and/or assaying (Tisone, Abstract).
In addition, Claim recites a third dispenser and then recites how the third dispenser functions. Claim 8 is an apparatus claim and MPEP 2114 recites that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Regarding Claim 9, the microfluidic system of claim 1 is obvious over McKeon in view of Tisone.
McKeon does not teach a liquid handling robot to move the multiwell plate after cells are dispensed into the individual wells.
In the analogous art of a quantitative cell dispensing apparatus using liquid droplet manipulation, for quantitatively dispensing cells from hydrophilic suspension containing a plurality of cells, Tisone teaches a liquid handling robot (referred to as one or more suitable robot arms [Para 0125]; See Para 0334…liquid handling robotics); See Para 0077…automated ultra-low volume liquid handling of biological samples in diagnostics, genomics and proteomics, among others) to move (See Para 0125… to move either the dispenser 528 and/or the carrier platform or table 512 having target 511) the multiwell plate (referred to as target substrate [Para 0128; Fig. 2C, ref. 511]; See Para 0124… The target 511 can comprise …such as one or more single-well receptacles, vials or tubes) after cells are dispensed (See Para 0124…as shown in FIG. 2C, a substrate or target 511 is mounted on a carrier platform, table or carriage 512 to receive reagent or liquid dispensed from the dispenser 528; See Para 0113…The BioJet Plus system can be used to dispense buffers, antibodies, enzymes or cells, among others.) into the individual wells (See Para 0124… The target 511 can comprise …such as one or more single-well receptacles, vials or tubes).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the microfluidic system of McKeon to have a liquid handling robot to move the multiwell plate after cells are dispensed into the individual wells, as taught by Tisone for the benefit of having the multi-channel dispensing head (e.g. dispensing head 410) advantageously enabling a substantially fully automatic and reproducible control of dispensing head positioning and micro-drop release times based on predetermined program patterns, e.g., using a control computer (Tisone, Para 0105); and this would include the manual or automatic transfer to microtiter plate or other sample containers between the store and hybridization/reader system (Tisone, Para 0299), allowing for the provision of novel and improved systems and methods for high speed arraying, hybridization, quantitative development and/or assaying (Tisone, Abstract).
In addition, Claim 9 recites a liquid handling robot and then recites how liquid handling robot functions. Claim 9 is an apparatus claim and MPEP 2114 recites that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Regarding Claim 10, the microfluidic system of claim 9 is obvious over McKeon in view of Tisone.
McKeon does not teach the liquid handling robot moves the multiwell plate to at least one of a cell incubator or a plate reader.
In the analogous art of a quantitative cell dispensing apparatus using liquid droplet manipulation, for quantitatively dispensing cells from hydrophilic suspension containing a plurality of cells, Tisone teaches that the liquid handling robot (referred to as one or more suitable robot arms [Para 0125]; See Para 0334…liquid handling robotics); See Para 0077…automated ultra-low volume liquid handling of biological samples in diagnostics, genomics and proteomics, among others) moves (See Para 0125… to move either the dispenser 528 and/or the carrier platform or table 512 having target 511) the multiwell plate (referred to as target substrate [Para 0128; Fig. 2C, ref. 511]; See Para 0124…The target 511 can comprise …such as one or more single-well receptacles, vials or tubes) to at least one of a cell incubator or a plate reader (See Para 0289…HYBRIDIZATION/READER MODULE: This module dispenses the sample to the test array followed by incubation and reading).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the microfluidic system of McKeon to have the liquid handling robot moves the multiwell plate to at least one of a cell incubator or a plate reader, as taught by Tisone for the benefit of having the multi-channel dispensing head (e.g. dispensing head 410) advantageously enabling a substantially fully automatic and reproducible control of dispensing head positioning and micro-drop release times based on predetermined program patterns, e.g., using a control computer (Tisone, Para 0105); and this would include the manual or automatic transfer to microtiter plate or other sample containers between the store and hybridization/reader system (Tisone, Para 0299), allowing for the provision of novel and improved systems and methods for high speed arraying, hybridization, quantitative development and/or assaying (Tisone, Abstract).
In addition, Claim 10 recites a liquid handling robot and then recites how liquid handling robot functions. Claim 10 is an apparatus claim and MPEP 2114 recites that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over McKeon et al (US20100086919A1, submitted in IDS, 02/24/2026) in view of Yamakami et al. (US20090274840A1)
Regarding Claim 20, McKeon teaches a micro fluidic system comprising:
a dispense head (See Annotated Fig. 3) comprising:
a first dispenser (referred to as one or more inlet modules [Para 0114; Fig. 3]) to dispense (See Para 0122… where the dispersed phase fluid is immiscible with the continuous phase fluid) a first biological cell type (See Para 0115…a droplet encapsulating one or more cells, thereby teaching “a first biological cell type”; See Para 0130…a plurality of B cells expressing a desired immunoglobulin) and a second dispenser (referred to as one or more inlet modules [Para 0114; Fig. 3]) to dispense (See Para 0122… where the dispersed phase fluid is immiscible with the continuous phase fluid) a second biological cell type (See Para 0115…a droplet encapsulating one or more cells, thereby teaching “a second biological cell type”; See Para 0130… a plurality of immortalized cells (e.g., myeloma cells));
a first dispenser channel (referred to as a first inlet channel [Para 0130]) to load cells (See Para 0103… a plurality of B cells expressing a desired immunoglobulin, through a first inlet channel) into a first cell staging chamber (See Annotated Fig. 1) to be dispensed by the first dispenser channel (referred to as one or more inlet modules [Para 0114; Fig. 3]), and a second dispenser channel (referred to as a second inlet channel [Para 0130]) to load cells (See Para 0130…a plurality of immortalized cells (e.g., myeloma cells) through a second inlet channel) into a second cell staging chamber (See Annotated Fig. 1) to be dispensed by the second dispenser(referred to as one or more inlet modules [Para 0114; Fig. 3]); and
one or more sensing circuits (referred to as detection module [Para 0114; Fig.3]) to detect single cells (See Para 0114…a detection module including a detection apparatus for evaluating the contents and/or characteristics of the coalesced droplets produced in the coalescence module; See Para 0122…interrogating the nanoreactor for a predetermined characteristic of the cells (such as fluorescence) within a detection module) in the first dispenser channel (referred to as one or more inlet modules [Para 0114; Fig. 3]) and the second dispenser channel (referred to as a second inlet channel [Para 0130]) to enable one cell at a time (See Para 0130…a plurality of immortalized cells (e.g., myeloma cells) through a second inlet channel) to be dispensed See Para 0122… where the dispersed phase fluid is immiscible with the continuous phase fluid) by the first dispenser (referred to as one or more inlet modules [Para 0114; Fig. 3]) and the second dispenser (referred to as one or more inlet modules [Para 0114; Fig. 3]), respectively.
McKeon does not teach a set of dispense heads; and
wherein the set of dispense heads have a staggered arrangement in which each dispense head in a first subset of the set of dispense heads extends farther out than each dispense head in a second subset of the set of dispense heads.
In the analogous art of an invention relates to an ink jet ink, an ink set, an ink jet recording method, an ink cartridge, a recording unit and an ink jet recording apparatus, Yamakami teaches a set of dispense heads (referred to as nozzle groups 101 including 101a and 101b [Para 0053; Fig. 1]); and
wherein the set of dispense heads (referred to as nozzle groups 101 including 101a and 101b [Para 0053; Fig. 1]) have a staggered arrangement (See Fig. 1 for the large nozzle 101a and small nozzle 101b; Also See Para 0191… a group of nozzles constituted of nozzles of 1 pL each and nozzles of 2 pL each in ejection volume which are arranged at arrangement intervals of 21.6 μm in a staggered manner is disposed along one side of the common liquid chamber) in which each dispense head in a first subset of the set of dispense heads extends farther out (See Fig. 1 for the small nozzles 101b extending out) than each dispense head in a second subset of the set of dispense heads (See Fig. 1 for the large nozzles 101a, thereby teaching “ each dispense head in a second subset…)).
Yamakami further teaches that in recent years, in such an ink jet recording method, it is required on the one hand to achieve much higher image quality than ever on the images thereby obtainable, and on the other hand it is further required to simultaneously achieve improvement in recording speed. As a method by which ink jet recorded images can be made higher in image quality, it is proposed that first nozzles and second nozzles both having ink channels different in length from each other are arranged in a staggered manner so as to achieve both good refill performance and high-density nozzle arrangement (see Japanese Patent Application Laid-open No. 2006-315395). (Para 0005).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the microfluidic system of McKeon in having a set of dispense heads; and wherein the set of dispense heads have a staggered arrangement in which each dispense head in a first subset of the set of dispense heads extends farther out than each dispense head in a second subset of the set of dispense heads, as taught by Yamakami for the benefit of arranging the nozzles in light of their ejection volumes (Yamakami, Para 0191, 0053), allowing for the provision of an ink jet ink which, when applied to a specific recording head achievable of higher image quality of ink jet recorded images and improvement of recording speed, promises a superior uniformity in color on plain paper, may less cause the positional deviation of satellite droplet impact and also may not damage the durability of the recording head (Yamakami, Para 0013).
In addition, Claim 20 recites a dispense head, a first dispenser, a first dispenser channel, a second dispenser, a second dispenser channel and one or more sensing circuits and then recites how these structures function. Claim 20 is an apparatus claim and MPEP 2114 recites that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Response to Arguments
Applicant's arguments filed on 03/29/2026, with respect to the objections on the drawings have been fully considered and are persuasive.
Applicant submits that FIGs. 2 and 13-15 have been amended to overcome the objection. No new matter is added by way of this amendment. Applicant respectfully requests for the objection to the drawings be withdrawn at least in view of the amendment to FIGs. 2 and 13-15.
Examiner respectfully agrees and the drawing objection is withdrawn.
Applicant’s arguments, see Page 7, filed 03/29/2026, with respect to the 35 U.S.C. §102 (a)(2) rejections on claims 1-8 and §103 on claims 9-10 and 20 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made for claims 1-10 in view of McKeon et al (US20100086919A1, submitted in IDS, 02/24/2026) in further view of Tisone et al. (US20130150266A1); and for Claim 20 in view of McKeon et al (US20100086919A1, submitted in IDS, 02/24/2026) in further view of Yamakami et al. (US20090274840A1).
Applicant submits that these rejections are moot because Shkolnikov does not qualify as prior art under 35 U.S.C. §§ 102 and 103. Pursuant to 35 U.S.C. §102(b)(2)(C) and 37 C.F.R. § 1.130(a), Applicant hereby states that the subject matter relied upon in Shkolnikov and the subject matter of the presently claimed invention were, not later than the effective filing date of the claimed invention, either owned by Hewlett-Packard Development Company, L.P. or subject to an obligation of assignment to Hewlett-Packard Development Company, L.P.
Accordingly, Shkolnikov qualifies at least for the common ownership exception under 35 U.S.C. § 102(b)(2)(C) and does not constitute prior art to the claims of the present application under 35 U.S.C. §§ 102 or 103.
Examiner respectfully agrees and the rejections of claims 1-10 and 20 with respect to Shkolnikov are withdrawn.
However, Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 02/24/2026 prompted the new ground(s) of rejection of Claims 1-10 and 20 presented in this Office action.
Conclusion
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 02/24/2026 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OYELEYE ALEXANDER ALABI whose telephone number is (571)272-1678. The examiner can normally be reached on M-F 7:30am-5:30pm.
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/OYELEYE ALEXANDER ALABI/ Examiner, Art Unit 1797
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