DETAILED 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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 16 January 2026 has been entered.
Response to Amendment
This is an office action in response to Applicant’s arguments and remarks filed on 16 January 2026. Claims 2-4 and 6-9 are currently pending in the application. Claims 7-9 are new claims. Claims 1 and 5 have been cancelled. Claims 2-4 and 6-9 are being examined herein.
Examiner notes because claim 6 is the new independent claim, it’s examination will be presented first before the dependent claims.
Status of Objections and Rejections
The rejection of claim 1 under 35 U.S.C. § 103 in view of Carter, et. al. (US 20070245810 A1; previously presented) in view of Nielson, et. al. (US 20190151848 A1; previously presented) and Perdigones Sanchez, et. al. (US 20190070603 A1; hereinafter Sanchez) are withdrawn in view of the cancellation.
The rejection of claim 5 under 35 U.S.C. § 103 in view of Carter in view of Nielson and Sanchez in further view of Dirckx, et. al. (US 20140342350 A1) are withdrawn in view of the cancellation.
The rejection of claims 2-4 under 35 U.S.C. § 103 in view of Carter in view of Nielson and Sanchez are withdrawn in view of amendments.
The rejection of claim 6 under 35 U.S.C. § 103 in view of Carter in view of Nielson, Sanchez, and Dirckx are withdrawn in view of amendments.
Response to Arguments
Applicant’s arguments, see Remarks pages. 6-9, filed 16 January 2026, with respect to the rejection(s) of claim(s) 1-4 under U.S.C. § 103 in view of Carter in view of Nielson and Sanchez and claims 5-6 under 35 U.S.C. § 103 in view of Carter in view of Nielson, Sanchez, and Dirckx 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 Therefore, the rejection has been withdrawn.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 in view of Carter, et. al. (US 20070245810 A1) in view of Fujimoto (US 20180043358 A1).
Applicant primarily argues against the use of Sanchez in combination with Carter because of the operational differences (Remarks, pg. 7, par. 04 – pg. 8, par. 02). Examiner agrees with Applicant regarding the operation differences of Carter and Sanchez.
Carter teaches a cartridge for analysis of fluids by movement through and mixing in chambers (Abstract). Carter teaches a cartridge that comprises two modules where a fluid is introduced with each module containing a chamber and a plunger, the plunger is moved by a mechanical device like a piston (Fig. 1).
Fujimoto teaches a microfluidic chip with plungers for introducing fluid into a fluid space (Abstract). Fujimoto teaches the microfluidic device comprises a driving apparatus to drive plungers to move fluid from fluid spaces into microchannels and ultimately to reaction space where all the fluids mix together (Fig. 1)
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 6, 2-4, 7, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Carter, et. al. (US 20070245810 A1) in view of Fujimoto (US 20180043358 A1).
Regarding claim 6, Carter teaches a cartridge for analysis of fluids by movement through and mixing in chambers (Abstract). Carter teaches a cartridge that comprises two modules 480 where a fluid is introduced with each module containing a chamber 486 and a plunger 481, the plunger 481 is moved by a mechanical device like a piston (Fig. 6; par. 0137) (a lab-on-a-chip with an upper… comprising a fluid driving area provided with at least two fluid driving systems). The cartridge additionally comprises a staging chamber 420 and a detection chamber 430 downstream the modules (Fig. 6) (a lower… comprising a microfluidic mixing area, for mixing such fluids). Carter teach parts of cartridge in contact with fluids are made of biocompatible materials (silicon) (par. 0138) (both the upper… and lower… being made of a biocompatible material). Carter teaches the respective upper and lower area/regions but does not explicitly disclose layers. Carter teaches these areas are adhered together by any suitable adhesive 424 to provide a fluid-tight seal (Fig. 6; par. 0125).
The modules each contain a chamber 486 where the fluid enters (wherein each fluid driving system is provided with at least one fluid inlet hole) and a plunger 481 attached to a mechanical device to move fluid through the module (Fig. 6; par. 0137) (and respective moving plungers, each plunger attached to a driver for moving the plungers forward and backward). Downstream the module, Carter teaches chamber 430 with micrometer dimensions (Fig. 6; par. 0067) wherein the fluid path between chamber 430 can include features to improve mixing (par. 0121-0122) (wherein the lower microfluidic mixing area is provided with at least one microfluidic mixing channel). Carter teaches between the module 480 and detection chamber is an opening 420 (Fig. 6) (and the fluid inlet holes and the microfluidic mixing channel are directly connected by a vertical communication hole).
Carter additionally teaches the plungers associated with the driving system of the modules are controlled by actuator 90 located on the cartridge (wherein the microfluidic device further comprises an actuator platform connected to the drivers) (Fig. 1; par. 0137). The module also includes, at the end of the plunger 1681, is a tip 1683 that mates with the opening 1682 opening to the staging chamber (Fig. 8C; par. 0135) (wherein the fluid inlet holes are provided with a closing plug inside). Carter teaches the plungers, are driven by a mechanical device (motor) that is controlled by the actuator (par. 0137). Carter teaches connector 54 (an electronic board) connects sensor 50 to a controller or “other system that may supply control signals” (a processor) to the device (par. 0058, 0092) (wherein the actuator platform comprises an electronic board with a processor and a motor for actuating the drivers to carry out several processes within the device at the same time).
Carter teaches a connector system 54 connecting sensor(s) to a controller or system to that supplies signals to and from the sensors and to other device components such as the valves and fluid monitors (par. 0058). Additionally, the device includes sensors 20 and fluid monitors 27 (one or more sensors) that are electrically connected to the actuators to provide a feedback loop, and wherein the actuators may be automated (Fig. 1; par. 0058, par. 0092-0094, par. 0098) (electronic connections for connecting the one or more sensor to the processor for controlling the actuation of the drivers based on data provided by the one or more sensors).
Carter is silent to the fluid driving area being in a layer and the microfluidic mixing area being on a separate layer and the two fluid driving systems being in a same horizontal plane.
Fujimoto teaches a microfluidic chip with plungers for introducing fluid into a fluid space (Abstract). Fujimoto teaches the microfluidic device comprises a driving apparatus 2 to drive plungers 21, 22, 23 to move fluid from fluid spaces S1, S2, and S3 into microchannels L1, L2, L3, and ultimately to reaction space S6 where all the fluids mix together (Fig. 1). Fujimoto teaches these elements can all be formed in layers with first member 51, making up the fluid spaces S1, S2, S3 that hold the plungers 21, 22, 23 and partially defines fluid space S5 where all the fluid mix together, and second member 52, which defines fluid space S5 (Fig. 3; par. 41). Fujimoto teaches keeping the microfluidic chip assembly primarily comprising of a first member and a second member, or two simple layers, the production of the microfluidic chip remains easy to produce, while still maintaining a complex internal structure (par. 0041).
While Fujimoto does teach first member 51 is a lower layer and second member 52 is an upper layer, Fujimoto does establish that the plunger-containing layer is separate from the mixing channel-container layer. Carter establishes the fluid driving area is provided in an upper area and the microfluidic mixing area is in a lower area (see above). Fujimoto teaches these areas can be made within a layered format to make the microfluidic chip easier to produce (par. 0041).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the upper fluid driving area and lower mixing area of Carter to be established in distinct layers as taught by Fujimoto in order to make the microfluidic chip more simplistic to produce, while still maintaining a complex internal structure. Because both microfluidic devices have chambers for plungers that are actuated for the moving fluid through a microfluidic device where they meet in a mixing chamber/channel, modifying the two areas to be located in two distinct layers as provided by Fujimoto, provides likewise sought functionality with reasonable expectation of success. MPEP 2143(I)(G).
Modified Carter is silent to wherein the upper layer and the lower layer are layered and welded together and to wherein the fluid inlet holes, the microfluidic mixing channel, and the vertical communication holes are drilled, molded, or cut by laser into the biocompatible material.
Fujimoto teaches a microfluidic chip with plungers for introducing fluid into a fluid space (Abstract). Fujimoto teaches the microfluidic device comprises a driving apparatus 2 to drive plungers 21, 22, 23 to move fluid from fluid spaces S1, S2, and S3 into microchannels L1, L2, L3, and ultimately to reaction space S6 where all the fluids mix together (Fig. 1). Carter teaches these elements can all be formed in layers by injection molding with the finer elements like vent holes and openings being formed by cutting after injection molding (par. 0044) (wherein the fluid inlet holes, the microfluidic mixing channel, and the vertical communication holes are drilled, molded, or cut by laser into the biocompatible material). Fujimoto teaches the individually formed layers of the same material are then adhered together by thermally fusing the layers together after heating the surfaced that will be joined together to a melting point and pressing them together (par. 0045) (wherein the upper layer and the lower layer are layered and welded together). Fujimoto teaches injection molding is an easy method for producing microfluidic devices with complex structures (par. 0044).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the production of the microfluidic device of Carter to be produced by injection molding and cutting and then thermally fusing the layers together as taught by Fujimoto because those are easy and well known production methods for microfluidic devices. Because both microfluidic devices have chambers for plungers that are actuated for the moving fluid through a microfluidic device where they meet in a mixing chamber/channel, modifying the production of the microfluidic device to be by injection molding, cutting, and welding together as provided by Fujimoto, provides likewise sought functionality with reasonable expectation of success. MPEP 2143(I)(G).
Modified Carter is silent to the one or more sensors embedded at a base of the upper layer at a position above the microfluidic mixing channel of the lower layer.
Carter teaches fluid monitor 27, a sensor that can take the form of, but not limited to, electrodes for the real-time monitoring of fluid presence in the microfluidic cartridge 10 (par. 0090). Carter teaches an initial example of the fluid monitor 27 (sensor) for monitoring chamber 30 (microfluidic mixing channel) by being placed on a lower surface of the chamber 30 (Fig. 1; par. 0091).
However, Carter teaches wherein the singular or multiple fluid monitors 27 can be installed in many different locations within the cartridge 10 (par. 0091). Specifically, Carter teaches the fluid monitor 27 is most advantageous when it is located at a position within the interior volume of the cartridge 10 that will allow the fluid monitor to be employed as the start of a feedback loop (par. 0091-0092). Since this particular parameter is recognized as a result-effective variable (i.e. a variable which achieves a recognized result), the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See MPEP 2144.05 (II)(A). Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to move the fluid monitor (sensor) to an area that best triggers the feedback loop, like embedded at a base of the upper layer at a position above the microfluidic mixing channel of the lower layer.
Regarding claim 2, modified Carter teaches the cartridge comprises a vent/vented opening 478 that can be located at multiple positions along the device in order to combat the changing pressure within the device (Carter, Fig. 6; par. 0111-0113) (wherein each of the fluid inlet holes is provided with a purge hole). Because the goal of the vent 478 is to reduce pressure within the device and is capable of being placed along the device, placing it in an area, like the fluid inlet hole, that needs the most correction or best corrects for pressure change.
Regarding claim 3, modified Carter teaches the plunger within a module has a tip 683 that is designed to pierce seals between the fluid inlet chamber and the staging chamber (Carter, Fig. 8A, 8B; par. 0131) (wherein each of the closing plugs is provided with piercing elements).
Regarding claim 4, modified Carter teaches the detection chamber of the device has one side that comprises a fluid monitor 27 (Carter, par. 0090) and at least one of a sensor 50 but can contain multiple sensors of a multiple types like acousto-mechanical sensor or electrochemical detection or conductivity sensors (Carter, Fig. 1; par. 0020-0021, 0098) (said one or more sensors are selected from the group consisting of: physical sensors, chemical sensors, and combinations thereof).
Regarding claim 7, modified Carter teaches fluid monitor 27, 427 that offers real-time fluid monitoring within the cartridge 10, 410, with Figure 6 showing the fluid monitor 427 at the start of chamber 430 (Carter, Fig. 1, 6; par. 0090-0091) (said one or more sensors are configured to detect a position of a fluid within said microfluidic mixing channel). Carter further teaches fluid monitor 27 is electronically connected to a controller in order to employ a feedback loop to operate actuators 90 as part of modules 80 (Carter, par. 0092) (said one or more sensors are configured to send a control signal to said processor… of said drivers when the fluid reaches a desired position in said microfluidic mixing channel). While the example given by Carter teaches a process to start actuation of actuators 90, it is understood by those of ordinary skill in the art that the only different in the process between starting and stopping the actuators based on the signal from the fluid monitor is how the automated device is programed and if the device can be programmed to start a process based on a signal, it is fully capable of stopping the same process with a signal (to send a control signal to said processor to stop actuation of said drivers).
Regarding claim 9, modified Carter teaches on a side of detection chamber 30 opposite of actuators 90 and modules 80 is chamber 40 wherein fluid moves from chamber 30 to chamber 40 (Carter, Fig. 1; par. 0059-060) (one or more chambers into the microfluidic mixing area for… outlet of one or more complementary fluids).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Carter, et. al. (US 20070245810 A1) in view of Fujimoto (US 20180043358 A1) as applied to claim 6 above, and further in view of Linder, et. al. (US 20110253224 A1).
Regarding claim 8, modified Carter teaches at least one of a sensor 50 but can contain multiple sensors of a multiple types like acousto-mechanical sensor or electrochemical detection or conductivity sensors within chamber 30 (Carter, Fig. 1, 6; par. 0020-0021, 0098). Carter additionally teaches temperature sensors and temperature control elements are also provided within the cartridge 10 (Carter, par. 0058) (said one or more sensors are configured to detect a temperature within said microfluidic mixing channel). Carter teaches sensor 50 can be connected to a controller through connector 54; connector 54 can receive and send electronic signals from sensors and send to a controller wherein additional connectors 54 are connected to other components on the cartridge 10, like modules 80 (Carter, Fig. 1; par. 0058) (said one more sensors are configured to send a control signal to said processor).
Modified Carter is silent to the sent control signal being used to start actuation of said drivers when the temperature reaches a desired temperature in said microfluidic mixing channel.
Linder teaches systems and methods for controlling fluid movement in microfluidic systems based on feedback signals of different processes (Abstract). Linder teaches an embodiment of the microfluidic device that comprises a cassette or cartridge 20 connected to a fluid control source 40 via inlets, a processor/control system 50, detector system 34 and a temperature regulating system 41 (Fig. 1; par. 0026). Linder teaches the control system can control fluids by the use of feedback from events taking place in the system (par. 0028). Linder teaches one such example of the feedback response is detecting a specific even or condition within a specific region of the device, like the temperature within a region of the device (par. 0033), and once this is detected, the signal is received by the control system 50 and the feedback from the control system is used to control another part of the microfluidic device, like the fluid control source (par. 0032) (to start actuation of said drivers when the temperature reaches a desired temperature in said microfluidic mixing channel). Linder teaches the embodiments that utilize feedback control loops to control fluid movement within a microfluidic device help simplify and reduce costs of complex microfluidic systems and provide additional quality control measures (par. 0003).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the temperature sensor and the controller of modified Carter to be directly involved in the feedback loop mechanism to control the fluid actuation as taught by Linder in order to simplify and reduce costs of complex microfluidic systems and provide additional quality control measures to the system. Because both microfluidic systems use a controller/control system to receive sensor signals, process those signals, and send out a signal in response to the received sensor signal, modifying temperatures sensors to provide the initial signal to being fluid actuation as provided by Linder, provides likewise sought functionality with reasonable expectation of success. MPEP 2143(I)(G).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MADISON T HERBERT whose telephone number is (571)270-1448. The examiner can normally be reached Monday-Friday 8:30a-5:00p.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M.T.H./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758