Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The Amendment filed 09/03/2026 has been entered. Claims 1-5 and 7-18 remain pending in the application. Claim 18 is withdrawn. Applicant’s amendments to the specification, drawings, and claims have overcome each and every objection and 112(b) rejections previously set forth in the Non-Final Office Action mailed 06/03/2026. New grounds of rejections necessitated by amendments are discussed below.
Claim Rejections - 35 USC § 103
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.
Claims 1-5 and 7-17 are rejected under 35 U.S.C. 103 as being unpatentable over Selden et al. (US 20170260567 A1; cited in the IDS filed 12/01/2022) in view of Coarsey et al. (Coarsey C, Coleman B, Kabir MA, Sher M, Asghar W. Development of a flow- free magnetic actuation platform for an automated microfluidic ELISA. RSC Adv. March 12, 2019; 9(15):8159-8168; cited in the IDS filed 12/17/2023; also see Supplemental Information of Coarsey).
Regarding claim 1, Selden teaches an automated platform (abstract and [0022],[0122] teaches a microfluidic biochip that can performed automated steps) for the detection of a virus, bacteria, and/or other organism of interest from a clinical sample (interpreted as an intended use, see MPEP 2114; [0149],[0369], [0378] teaches interrogation of pathogens, such as bacteria in blood; [0119] teaches detection of DNA from human, bacterial, and viral clinical and research samples), said automated platform comprising:
a disposable microfluidic chip ([0015],[0119] teaches a biochip including microfluidic features; [0130] teaches the biochip is disposable) for receiving the clinical sample therethrough ([0017] teaches a chamber to receive a sample; [0119] teaches a sample is inserted into the biochip) for isolating, purifying and amplifying the virus, bacteria, and/or other organism of interest in the clinical samples ([0119] teaches purification, amplification, and separation, i.e. isolation, of human, bacterial, and viral clinical and research samples);
a magnetic actuation platform ([0132] and [0145] teach magnetic drive mechanisms to drive, i.e. actuate, fluids throughout the biochip; [0134] teaches magnetic subsystems); said magnetic actuation platform being activated to convey the clinical sample through said disposable microfluidic chip ([0132] and [0145] teach magnetic drive mechanisms to drive fluids throughout the biochip; therefore, the magnetic drive mechanisms is capable of being activated to convey samples through the biochip); and
a surface heater ([0144], “heating elements”; [0252] teaches heaters and heater plates) for heating the clinical samples ([0122]-[0123], [0198], [0252]).
Selden fails to teach: wherein the disposable microfluidic chip comprises a plurality of independent aqueous chambers, and wherein elution and amplification of the virus, bacteria, and/or organism of interest takes place within one chamber of the plurality of independent aqueous chambers.
Selden teaches the biochip includes at least one chamber to receive a sample and an amplification chamber ([0017]). Selden teaches the biochip includes various chambers, such as reaction chambers and detection regions ([0144]). Selden teaches flow control steps that includes washing ([0199]). Selden teaches a wash solution from a wash reagent chamber is introduced to a chamber ([0310]). Selden teaches a pneumatic subsystem to release an elution solution stored in the microfluidic processing subassembly to release the bound DNA from a purification system to generate an eluate containing purified DNA ([0024]). Selden teaches elution buffer driven from an elution reagent chamber into an eluate holding chamber ([0341]). Selden teaches DNA purification and amplification of samples including human, bacterial, and viral clinical and research samples ([0119]). Selden teaches an example of purifying bacterial nucleic acids and performing amplification on the purified DNA ([0387]).
Coarsey teaches an automated platform (abstract and Figs. 1-3 teaches a microfluidic immunoassay detection platform for automated microfluidic assays) for the detection of a virus, bacteria, and/or other organism of interest from a clinical sample (abstract; page 8167, “Conclusions”), said automated platform comprising: a disposable microfluidic chip (Figs. 1-3 teach a microfluidic chip, which is interpreted as “disposable” since the chip is structurally capable of being disposed) for receiving the clinical sample (page 8162, left column, first full paragraph teaches loading a sample into a reaction well of the microfluidic chip; therefore, the microfluidic chip is capable of receiving a clinical sample); a magnetic actuation platform (Fig. 3); said magnetic actuation platform being activated to convey samples through the disposable microfluidic chip (pages 8160-8161, section, “Platform automation and bead control”). Coarsey teaches wherein the disposable microfluidic chip (Figs. 1-3 and 6; page 8160, section, “Microfluidic chip design”) comprises plurality of independent aqueous chambers (Figs. 1-3 and 6 page 8160, section, “Microfluidic chip design” teach reagent wells), the plurality of independent aqueous chambers comprising: an inlet chamber (Fig. 1, interpreted as the primary well); at least one washing buffer chamber (Fig. 1, interpreted as the well where beads are mixed with a second antibody); an amplification chamber (Fig. 1, interpreted as the well for assay color development); and an unconnected oval-shaped sensor chamber (Fig. 1 and page 8162, right column, teaches a larger oil retention well, which is interpreted as the right most oval-shaped sensor chamber; Fig. 1 and “Microfluidic chip design” teach elliptical mineral oil wells are separated by reagent wells, therefore the right most oval-shaped sensor chamber is interpreted as at least unconnected from the first reagent well since it is separated from the first reagent well via other aqueous reagent wells, elliptical mineral oil wells, and channels). Coarsey teaches the chip is cost-effective, requires small reagent microfluidic volumes, provides quick assay turnaround and quantitative results, and therefore is beneficial for potential point of care applications (page 8167, “Conclusion”); and the highly versatile platform for magnetic bead-based assays can be developed for detection of viral and bacterial pathogens (page 8167, “Conclusion”).
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 disposable microfluidic chip of Selden to incorporate Selden’s teachings of a biochip including a chamber to receive a sample, an amplification chamber, reaction chambers and detection regions, washing steps, and chambers for washing ([0017],[0144],[0199],[0310]) and elution and amplification of samples such as bacterial and viral samples ([0024],[0119],[0341],[0387]) and Coarsey’s teachings of a microfluidic chip with a plurality of independent aqueous chambers and the chambers including inlet, washing, amplification, and sensor chambers (Figs. 1-3,6; page 8160, section, “Microfluidic chip design”) to provide: wherein the disposable microfluidic chip comprises a plurality of independent aqueous chambers, and wherein elution and amplification of the virus, bacteria, and/or organism of interest takes place within one chamber of the plurality of independent aqueous chambers. Doing so would have a reasonable expectation of successfully improving separation of chambers for microfluidic processing of samples and providing a cost-effective chip that requires small reagent microfluidic volumes, and providing quick assay turnaround and quantitative results, and therefore is beneficial for potential point of care applications (Coarsey, page 8167, “Conclusion”) and improving versatility of the chip for detection of viral and bacterial pathogens (Coarsey, page 8167, “Conclusion”).
Note that “a virus, bacteria, and/or other organism of interest from a clinical sample” and “elution and amplification”, are not positively recited structurally and are interpreted as a functional limitation or intended use of the claimed system. A claim is only limited by positively recited elements; thus, inclusion of the material or article (“a virus, bacteria, and/or other organism of interest from a clinical sample” and “elution and amplification”) worked upon by a structure (automated platform) being claimed does not impart patentability to the claims (see MPEP 2115).
Note that an intended use or functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use or functional limitations, then it meets the claim. See MPEP 2114. The apparatus of modified Selden is identical to the presently claimed structure. Modified Selden discloses the claimed disposable microfluidic chip comprising a plurality of independent aqueous chambers, a magnetic actuation platform, and a surface heater as claimed and therefore, would have the ability to perform the use or function (e.g. “elution and amplification of the virus, bacteria, and/or organism of interest takes place within one chamber of the plurality of independent aqueous chambers”) recited in the claim. See MPEP 2112.01 (I).
Regarding claim 2, Selden fails to teach: wherein the disposable microfluidic chip comprises three layers comprising: a top layer comprised of poly(methyl methacrylate) (PMMA) at a thickness of 750 um; a middle comprised of poly(methyl methacrylate) (PMMA) at a thickness of 1.5 mm; and a bottom layer comprised of poly(methyl methacrylate) (PMMA) at a thickness of 750 um.
Selden teaches the biochip comprises layers that contain microfluidic features ([0144]), and the biochip can incorporate additional layers ([0145]). Selden teaches the biochip may include multiple layers ([0154]-[0156]). Selden teaches the biochips can be fabricated by polymers, such as PMMA ([0152]). Selden teaches driving fluids through a biochip by a magnetic drive mechanism ([0132]).
Coarsey teaches an automated platform (abstract and Figs. 1-3 teaches a microfluidic immunoassay detection platform for automated microfluidic assays) for the detection of a virus, bacteria, and/or other organism of interest from a clinical sample (abstract; page 8167, “Conclusions”), said automated platform comprising: a disposable microfluidic chip (Figs. 1-3 teach a microfluidic chip, which is interpreted as “disposable” since the chip is structurally capable of being disposed) for receiving the clinical sample (page 8162, left column, first full paragraph teaches loading a sample into a reaction well of the microfluidic chip; therefore, the microfluidic chip is capable of receiving a clinical sample); a magnetic actuation platform (Fig. 3); said magnetic actuation platform being activated to convey samples through the disposable microfluidic chip (pages 8160-8161, section, “Platform automation and bead control”). Coarsey teaches wherein the disposable microfluidic chip comprises three layers (Fig. 2a; page 8160, section “Microfluidic chip design”) comprising: a top layer comprised of poly(methyl methacrylate) (PMMA) at a thickness of 750 um (Supplemental Information, Table 1, teaches Chips C or D with a top loading layer being 750 um thick); a middle comprised of poly(methyl methacrylate) (PMMA) at a thickness of 1.5 mm (page 8163, left column, first full paragraph teaches 1.5 mm PMMA well depth; Supplemental Information, Table 1, teaches Chips C or D with a middle well layer being 1.5 mm thick); and a bottom layer comprised of poly(methyl methacrylate) (PMMA) at a thickness of 750 um (Supplemental Information, Table 1, teaches Chips C or D with a bottom base layer being 750 um thick). Coarsey teaches the dimensions of the microfluidic chip allowed beads to travel through the chip with minimal bead loss, enabling reliable and optimized quantitation (page 8163, left column, first full paragraph). Coarsey teaches the chip is cost-effective, requires small reagent microfluidic volumes, provides quick assay turnaround and quantitative results, and therefore is beneficial for potential point of care applications (page 8167, “Conclusion”); and the highly versatile platform for magnetic bead-based assays can be developed for detection of viral and bacterial pathogens (page 8167, “Conclusion”).
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 disposable microfluidic chip of Selden to incorporate Selden’s teachings of biochips with multiple layers and fabricated from PMMA ([0145],[0154]-[0156], [0152]) and magnetic drive mechanisms to drive fluids ([0132]) and Coarsey’s teachings of an automated microfluidic chip with three PMMA layers of the claimed thicknesses (Figs. 1-3; page 8160, section “Microfluidic chip design”; page 8163, left column, first full paragraph; Supplemental Information, Table 1) to provide: wherein the disposable microfluidic chip comprises three layers comprising: a top layer comprised of poly(methyl methacrylate) (PMMA) at a thickness of 750 um; a middle comprised of poly(methyl methacrylate) (PMMA) at a thickness of 1.5 mm; and a bottom layer comprised of poly(methyl methacrylate) (PMMA) at a thickness of 750 um. Doing so would have a reasonable expectation of successfully optimizing the layers and dimensions of the microfluidic chip to enable desired materials to travel through the chip with minimal loss of materials such as beads, therefore enabling reliable and optimized quantitation (Coarsey, page 8163, left column, first full paragraph). Additionally, doing so would have a reasonable expectation of providing a cost-effective chip that requires small reagent microfluidic volumes and providing quick assay turnaround and quantitative results, and therefore is beneficial for potential point of care applications (Coarsey, page 8167, “Conclusion”) and improving versatility of the chip for detection of viral and bacterial pathogens (Coarsey, page 8167, “Conclusion”).
Regarding claim 3, Selden fails to teach: wherein the plurality of independent aqueous chambers are separated by a plurality of elliptical shaped valving chambers containing mineral oil which work as valves, the plurality of independent aqueous chambers comprising: an inlet chamber; at least one washing buffer chamber; an amplification chamber; and an unconnected oval-shaped sensor chamber.
Selden teaches the biochip includes a chamber to receive a sample and an amplification chamber ([0017]). Selden teaches the biochip includes various chambers, such as reaction chambers and detection regions ([0144]). Selden teaches flow control steps that includes washing ([0199]). Selden teaches a wash solution from a wash reagent chamber is introduced to a chamber ([0310]).
Coarsey teaches an automated platform (abstract and Figs. 1-3 teaches a microfluidic immunoassay detection platform for automated microfluidic assays) for the detection of a virus, bacteria, and/or other organism of interest from a clinical sample (abstract; page 8167, “Conclusions”), said automated platform comprising: a disposable microfluidic chip (Figs. 1-3 teach a microfluidic chip, which is interpreted as “disposable” since the chip is structurally capable of being disposed) for receiving the clinical sample (page 8162, left column, first full paragraph teaches loading a sample into a reaction well of the microfluidic chip; therefore, the microfluidic chip is capable of receiving a clinical sample); a magnetic actuation platform (Fig. 3); said magnetic actuation platform being activated to convey samples through the disposable microfluidic chip (pages 8160-8161, section, “Platform automation and bead control”). Coarsey teaches wherein the disposable microfluidic chip (Figs. 1-3 and 6; page 8160, section, “Microfluidic chip design”) comprises plurality of independent aqueous chambers (Figs. 1-3 and 6 page 8160, section, “Microfluidic chip design” teach reagent wells) separated by a plurality of elliptical shaped valving chambers containing mineral oil which work as valves (Figs. 1-3 and 6 and page 8160, section, “Microfluidic chip design” teach elliptical mineral oil wells, which are interpreted to work as valves as shown in Figs. 1 and 6), the plurality of independent aqueous chambers comprising: an inlet chamber (Fig. 1, interpreted as the primary well); at least one washing buffer chamber (Fig. 1, interpreted as the well where beads are mixed with a second antibody); an amplification chamber (Fig. 1, interpreted as the well for assay color development); and an unconnected oval-shaped sensor chamber (Fig. 1 and page 8162, right column, teaches a larger oil retention well, which is interpreted as the right most oval-shaped sensor chamber; Fig. 1 and “Microfluidic chip design” teach elliptical mineral oil wells are separated by reagent wells, therefore the right most oval-shaped sensor chamber is interpreted as at least unconnected from the first reagent well since it is separated from the first reagent well via other aqueous reagent wells, elliptical mineral oil wells, and channels). Coarsey teaches the chip is cost-effective, requires small reagent microfluidic volumes, provides quick assay turnaround and quantitative results, and therefore is beneficial for potential point of care applications (page 8167, “Conclusion”); and the highly versatile platform for magnetic bead-based assays can be developed for detection of viral and bacterial pathogens (page 8167, “Conclusion”).
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 disposable microfluidic chip of modified Selden to incorporate Selden’s teachings of a biochip including a chamber to receive a sample, an amplification chamber, reaction chambers and detection regions, washing steps, and chambers for washing ([0017],[0144],[0199],[0310]) and Coarsey’s teachings of a microfluidic chip with a plurality of independent aqueous chambers separated by elliptical shaped valving chambers containing mineral oils and the chambers including inlet, washing, amplification, and sensor chambers (Figs. 1-3,6; page 8160, section, “Microfluidic chip design”) to provide: wherein the plurality of independent aqueous chambers are separated by a plurality of elliptical shaped valving chambers containing mineral oil which work as valves, the plurality of independent aqueous chambers comprising: an inlet chamber; at least one washing buffer chamber; an amplification chamber; and an unconnected oval-shaped sensor chamber. Doing so would have a reasonable expectation of successfully improving separation of chambers for microfluidic processing of samples and providing a cost-effective chip that requires small reagent microfluidic volumes, and providing quick assay turnaround and quantitative results, and therefore is beneficial for potential point of care applications (Coarsey, page 8167, “Conclusion”) and improving versatility of the chip for detection of viral and bacterial pathogens (Coarsey, page 8167, “Conclusion”).
Regarding claim 4, modified Selden fails to teach: wherein the top layer of the disposable microfluidic chip contains two pipette inlets above the plurality of independent aqueous chambers.
Coarsey teaches the top layer of the disposable microfluidic chip contains two pipette inlets (0.4 mm diameter) above each chamber (page 8160, section, “Microfluidic chip design” teaches the top layer includes pipette inlets with 0.4 mm diameter for reagent loading and air escape while the wells are filled), which allows for easy access to each well for reagent loading and air escape while wells are filled (page 8160, section, “Microfluidic chip design”).
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 top layer of modified Selden to incorporate Coarsey’s teachings of each well having two pipette inlets for easy access to each well for reagent loading and air escape while wells are filled (page 8160, section, “Microfluidic chip design”) to provide: wherein the top layer of the disposable microfluidic chip contains two pipette inlets above the plurality of independent aqueous chambers. Doing so would have a reasonable expectation of successfully improving access to each well for reagent loading and improving air escape while wells are filled (page 8160, section, “Microfluidic chip design”).
Regarding claim 5, modified Selden further teaches wherein one inlet of the two pipette inlets discharges a fluid into the disposable microfluidic chip and another inlet of the two pipette inlets liberates air out of the plurality of independent aqueous chambers (see above claim 4; modified Selden in view of Coarsey provides the two pipette inlets, one for reagent loading and another for air escape; Coarsey, page 8160, section, “Microfluidic chip design”).
Regarding claim 7, modified Selden fails to teach: wherein the at least one washing buffer chamber comprises a first washing buffer chamber and a second washing buffer chamber.
Coarsey teaches wherein the at least one washing buffer chamber comprises a first washing buffer chamber and a second washing buffer chamber (Supplemental Information, page 6, Chip Loading Diagram S4, teaches wash buffer PBS in chambers 1a and 1c). Coarsey teaches beads were moved through a washing phase, mixed with a secondary antibody, and after a final rinsing stage, the beads are moved to a final reaction well (Fig. 1). Coarsey teaches wash steps to remove oil encapsulation and enhance assay reactions (page 8165, right column, first paragraph).
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 at least one washing buffer chamber of modified Selden to incorporate Coarsey’s teachings of two washing buffer chambers (Fig. 1; Supplemental Information, page 6, Chip Loading Diagram S4) to provide: wherein the at least one washing buffer chamber comprises a first washing buffer chamber and a second washing buffer chamber. Doing so would have a reasonable expectation of successfully improving washing a sample for enhanced assay reactions and detection.
Regarding claim 8, modified Selden fails to teach: wherein the plurality of elliptical shaped valving chambers comprises a first valving chamber, a second valving chamber, and a third valving chamber.
Coarsey teaches wherein the plurality of elliptical shaped valving chambers (Fig. 1; page 8160, section, “Microfluidic chip design”, elliptical mineral oil wells; Supplemental Information, page 6, Chip Loading Diagram S4) comprises a first valving chamber, a second valving chamber, and a third valving chamber (Fig. 1 and Supplemental Information, page 6, Chip Loading Diagram S4, interpreted as any three of the four elliptical mineral oil wells 2e, 2d, 2c, 2b). Coarsey teaches between the diamond reaction phase wells, ovals containing oil prevent any cross-contamination of the reaction (page 8162, left column).
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 plurality of elliptical shaped valving chambers of modified Selden to incorporate Coarsey’s teachings of at least three elliptical mineral oil wells (Figs. 1 and Supplemental Information, page 6, Chip Loading Diagram S4) to provide: wherein the plurality of elliptical shaped valving chambers comprises a first valving chamber, a second valving chamber, and a third valving chamber. Doing so would have a reasonable expectation of successfully improving separation of the aqueous chambers and preventing cross-contamination between the chambers (Coarsey, page 8162, left column).
Regarding claim 9, modified Selden fails to teach: wherein the unconnected oval-shaped sensor chamber is separated from the inlet chamber, the at least one washing buffer chamber, and the amplification chamber.
Coarsey teaches the unconnected oval-shaped sensor chamber is separated from the other chambers (Fig. 1 and page 8162, right column, teaches a larger oil retention well, which is interpreted as the right most oval-shaped sensor chamber; Fig. 1 and “Microfluidic chip design” teach the elliptical mineral oil wells are separated by reagent wells, therefore the right most oval-shaped sensor chamber is interpreted as at least separated from the other wells since there is a physical separation via other wells and channels).
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 disposable microfluidic chip of Selden to incorporate Coarsey’s teachings of a microfluidic chip with a plurality of independent aqueous chambers separated by elliptical shaped valving chambers containing mineral oils and the chambers including inlet, washing, amplification, and sensor chambers (Figs. 1-3,6; page 8160, section, “Microfluidic chip design”) to provide: wherein the unconnected oval-shaped sensor chamber is separated from the inlet chamber, the at least one washing buffer chamber, and the amplification chamber. Doing so would have a reasonable expectation of successfully improving separation of chambers for microfluidic processing of samples and providing a cost-effective chip that requires small reagent microfluidic volumes, and providing quick assay turnaround and quantitative results, and therefore is beneficial for potential point of care applications (Coarsey, page 8167, “Conclusion” and improving versatility of the chip for detection of viral and bacterial pathogens (Coarsey, page 8167, “Conclusion”).
Regarding claim 10, Selden fails to teach: wherein activation of the magnetic actuation platform is executed by at least one small magnet which is enclosed with stepper motor and able to move bidirectionally on stepper motor linear slide rails.
Coarsey teaches magnetic actuation is executed by at least one small magnet which is enclosed with stepper motor and able to move bidirectionally on stepper motor linear slide rails (pages 8160-8161, section “Platform automation and bead control” and Fig. 3 teaches magnets enclosed with a stepper motor that moves in forward and backwards directions on linear slide rails). Coarsey teaches the magnetic actuator allows for automatically moving microparticles through the microfluidic chip (page 8160, section “Platform automation and bead control”). Coarsey teaches the chip is cost-effective, requires small reagent microfluidic volumes, provides quick assay turnaround and quantitative results, and therefore is beneficial for potential point of care applications (page 8167, “Conclusion”); and the highly versatile platform for magnetic bead-based assays can be developed for detection of viral and bacterial pathogens (page 8167, “Conclusion”).
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 disposable microfluidic chip of Selden to incorporate Coarsey’s teachings of a magnetic actuator for automatically moving microparticles through the microfluidic chip (pages 8160-8161, section “Platform automation and bead control” and Fig. 3; page 8167, “Conclusion”) to provide: wherein activation of the magnetic actuation platform is executed by at least one small magnet which is enclosed with stepper motor and able to move bidirectionally on stepper motor linear slide rails. Doing so would have a reasonable expectation of successfully improving automation of movement of desired particles in the chip and therefore improving microfluidic processing of samples and providing a cost-effective chip that requires small reagent microfluidic volumes, and providing quick assay turnaround and quantitative results, and therefore is beneficial for potential point of care applications (Coarsey, page 8167, “Conclusion”) and improving versatility of the chip for detection of viral and bacterial pathogens (Coarsey, page 8167, “Conclusion”).
Regarding claim 11, modified Selden fails to teach: wherein the stepper motor linear slide rails are connected to the stepper motor by a power output wire.
Coarsey teaches the magnetic actuator allows for automatically moving microparticles through the microfluidic chip (page 8160, section “Platform automation and bead control”; Fig. 3). Coarsey teaches the stepper motor linear slide rails are connected to the stepper motor by a power output wire (Fig. 3). Coarsey teaches the chip is cost-effective, requires small reagent microfluidic volumes, provides quick assay turnaround and quantitative results, and therefore is beneficial for potential point of care applications (page 8167, “Conclusion”); and the highly versatile platform for magnetic bead-based assays can be developed for detection of viral and bacterial pathogens (page 8167, “Conclusion”).
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 disposable microfluidic chip of Selden to incorporate Coarsey’s teachings of a magnetic actuator for automatically moving microparticles through the microfluidic chip (pages 8160-8161, section “Platform automation and bead control” and Fig. 3; page 8167, “Conclusion”) to provide: wherein the stepper motor linear slide rails are connected to the stepper motor by a power output wire. Doing so would have a reasonable expectation of successfully providing power to the magnetic actuation platform and improving automation of movement of desired particles in the chip, improving microfluidic processing of samples, and providing a cost-effective chip that requires small reagent microfluidic volumes, and providing quick assay turnaround and quantitative results, and therefore is beneficial for potential point of care applications (Coarsey, page 8167, “Conclusion”) and improving versatility of the chip for detection of viral and bacterial pathogens (Coarsey, page 8167, “Conclusion”).
Regarding claim 12, Selden further teaches wherein the surface heater comprises an in-built surface heater ([0144] teaches the biochip includes thermoplastic layers that contain heating elements, i.e. in-built surface heater) to control a temperature required for isothermal amplification (interpreted as an intended use, see MPEP 2114; [0125] teaches scripted process steps for amplification includes repeating cycling of temperatures, which includes 70 °C; therefore, the heater is capable of controlling a temperature required for isothermal amplification); wherein the surface heater is activated starting from an isothermal amplification procedure to a temperature of 70 °C ± 2°C (interpreted as an intended use, see MPEP 2114; [0125] teaches scripted process steps for amplification includes repeating cycling of temperatures, which includes 70 °C; therefore, the heater is capable of activating starting from an isothermal amplification procedure to a temperature of 70 °C).
Note that “to control a temperature required for isothermal amplification; wherein the surface heater is activated starting from an isothermal amplification procedure to a temperature of 70 °C ± 2°C” is interpreted as an intended use or functional limitation. Note that an intended use and functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use or functional limitations, then it meets the claim. See MPEP 2114. The apparatus of modified Selden is identical to the presently claimed structure. Modified Selden discloses the claimed surface heater that can heat at 70 °C as claimed and therefore, would have the ability to perform the use recited in the claim. See MPEP 2112.01 (I).
Regarding claim 13, modified Selden fails to teach: wherein the sensor chamber and the amplification chamber are filled with a reagent and the surface heater is attached to both chambers.
Selden teaches the biochip includes all reagents needed to process a sample ([0021]). Selden teaches various chambers comprising reagents ([0144]). Selden teaches a PCR reaction mix that is heated in a thermal cycling chamber ([0024]). Selden teaches thermal chambers are heated to heat samples ([0122]). Selden teaches a PCR amplification reaction including changing the temperature of a chamber ([0125]). Selden teaches a chamber with a fluid and reaction is heated ([0198]). Selden teaches heating the chip to establish and maintain temperature uniformity ([0252]).
Coarsey teaches various chambers filled with a reagent (Fig. 1 teaches antibody-coated superparamagnetic beads, i.e. reagent, is filled and transported through the reagent wells and mineral oil wells). Coarsey teaches the chip is cost-effective, requires small reagent microfluidic volumes, provides quick assay turnaround and quantitative results, and therefore is beneficial for potential point of care applications (page 8167, “Conclusion”); and the highly versatile platform for magnetic bead-based assays can be developed for detection of viral and bacterial pathogens (page 8167, “Conclusion”).
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 automated platform of modified Selden to incorporate Selden’s teachings of chambers with reagents, heating chambers, and heating the chip to maintain temperature uniformity ([0021], [0024], [0122],[0125],[0144],[0198],[0198]) and Coarsey’s teachings of chambers filled with reagents (Fig. 1) to provide: wherein the sensor chamber and the amplification chamber are filled with a reagent and the surface heater is attached to both chambers. Doing so would have a reasonable expectation of successfully improving sample processing with an appropriate reagent and improving control of temperature in the chambers.
Regarding claim 14, modified Selden fails to teach wherein the magnetic actuation platform is coordinated by an automated circuit board and at least one magnetic bead movement from one chamber to another.
Coarsey teaches magnetic actuation is coordinated by an automated circuit board (pages 8160-8161, section “Platform automation and bead control” teaches a microprocessor, such as a PCB, for software control of the magnetic actuation of the microfluidic chip) and the at least one magnetic bead movement from one chamber to another (pages 8161-8162, section “M-ELISA with mechanical actuation platform” teaches the beads were moved between wells, i.e. chambers). Coarsey teaches the chip is cost-effective, requires small reagent microfluidic volumes, provides quick assay turnaround and quantitative results, and therefore is beneficial for potential point of care applications (page 8167, “Conclusion”); and the highly versatile platform for magnetic bead-based assays can be developed for detection of viral and bacterial pathogens (page 8167, “Conclusion”).
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 disposable magnetic actuation platform of modified Selden to incorporate Coarsey’s teachings of a magnetic actuator with a PCB for automatically moving microparticles through wells of the microfluidic chip (pages 8160-8161, section “Platform automation and bead control”; pages 8161-8162, section “M-ELISA with mechanical actuation platform”; Fig. 3; page 8167, “Conclusion”) to provide: wherein the magnetic actuation platform is coordinated by an automated circuit board and at least one magnetic bead movement from one chamber to another. Doing so would have a reasonable expectation of successfully improving automation of movement of desired particles between chambers of the chip, improving microfluidic processing of samples, providing a cost-effective chip that requires small reagent microfluidic volumes, and providing quick assay turnaround and quantitative results, and therefore is beneficial for potential point of care applications (Coarsey, page 8167, “Conclusion”) and improving versatility of the chip for detection of viral and bacterial pathogens (Coarsey, page 8167, “Conclusion”).
Regarding claim 15, Selden further teaches wherein an automated circuit board ([0122] teaches processing steps are performed by automated, computer-controlled scripts; [0134] teaches process control and computer subsystems; [0303] teaches a computer based controller to implement the script automatically; therefore, the platform that includes computer based controllers automated control of scripts are interpreted as an automated circuit board) controls the temperature of reagents enclosed in an amplification chamber of the microfluidic chip ([0122],[0303] teaches a computer based controller to automatically control subsystems; [0122] teaches automated computer-controlled scripts include heating samples within the thermal chambers, therefore is capable of controlling the temperature of reagents enclosed in an amplification chamber; [0123],[0125] teaches automated scripts for heating a chamber for an amplification reaction; [0156] teaches reagents for amplification reactions).
Regarding claim 16, Selden further teaches wherein multiple samples can be tested simultaneously (interpreted as an intended use, see MPEP 2114; [0127] and [0149] teaches processing multiple samples in parallel, therefore allowing for interrogation of a large number of pathogens and cellular processes simultaneously).
Regarding claim 17, note that “virus” of claim 1 and “Dengue Virus (DENY), Zika Virus (ZIKV), Human Immunodeficiency Virus (HIV), coronavirus, and Hepatitis C Virus (HCV)” of claim 17 are not positively recited structurally and is interpreted as an intended use of the claimed system. A claim is only limited by positively recited elements; thus, inclusion of the material or article (“virus”; “Dengue Virus (DENY), Zika Virus (ZIKV), Human Immunodeficiency Virus (HIV), coronavirus, and Hepatitis C Virus (HCV)”) worked upon by a structure (automated platform) being claimed does not impart patentability to the claims (see MPEP 2115).
Note that an intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended uses, then it meets the claim. See MPEP 2114. The apparatus of Selden is identical to the presently claimed structure. Selden discloses the claimed disposable microfluidic chip, magnetic actuation platform, and surface heater (see above claim 1) as claimed and therefore, would have the ability to perform the use recited in the claim (i.e. detection of one of DENY, ZIKV, HIV, coronavirus, and HCV). See MPEP 2112.01 (I).
Response to Arguments
Applicant’s arguments, see pages 8-11, filed 09/03/2026, with respect to the drawing objections, specification objections, claim objections, and rejections under 35 U.S.C. 112(b) have been fully considered and are persuasive. The drawing objections, specification objections, claim objections, and rejections under 35 U.S.C. 112(b) of 06/03/2026 have been withdrawn.
Applicant’s arguments, see pages 12-14, filed 09/30/2026, with respect to the rejections of claims 1, 12, and 15-17 under 35 U.S.C. 102(a)(1) and 102(a)(2) and claims 2-11 and 13-14 under 35 U.S.C. 103, specifically regarding amended claim 1 including the new limitation of “the disposable microfluidic chip comprises a plurality of independent aqueous chambers, and wherein elution and amplification of the virus, bacteria, and/or organism of interest takes place within one chamber of the plurality of independent aqueous chambers”, have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration of the new limitations of amended claim 1, a new ground(s) of rejection is made in view of Selden et al. (US 20170260567 A1; cited in the IDS filed 12/01/2022) in view of Coarsey et al. (Coarsey C, Coleman B, Kabir MA, Sher M, Asghar W. Development of a flow- free magnetic actuation platform for an automated microfluidic ELISA. RSC Adv. March 12, 2019; 9(15):8159-8168; cited in the IDS filed 12/17/2023; also see Supplemental Information of Coarsey).
Applicant's arguments, see page 13, filed 09/03/2026, regarding the combination of Selden and Coarsey, have been fully considered but they are not persuasive.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references of Selden and Coarsy (Remarks, page 13), the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, and as discussed in detail in the rejection of claim 1 under 35 U.S.C. 103: it would have been obvious to one of ordinary skill in the art to have modified the disposable microfluidic chip of Selden to incorporate Selden’s teachings of a biochip including a chamber to receive a sample, an amplification chamber, reaction chambers and detection regions, washing steps, and chambers for washing ([0017],[0144],[0199],[0310]) and elution and amplification of samples such as bacterial and viral samples ([0024],[0119],[0341],[0387]) and Coarsey’s teachings of a microfluidic chip with a plurality of independent aqueous chambers and the chambers including inlet, washing, amplification, and sensor chambers (Figs. 1-3,6; page 8160, section, “Microfluidic chip design”) to provide: wherein the disposable microfluidic chip comprises a plurality of independent aqueous chambers, and wherein elution and amplification of the virus, bacteria, and/or organism of interest takes place within one chamber of the plurality of independent aqueous chambers. Doing so would have a reasonable expectation of successfully improving separation of chambers for microfluidic processing of samples and providing a cost-effective chip that requires small reagent microfluidic volumes, and providing quick assay turnaround and quantitative results, and therefore is beneficial for potential point of care applications (Coarsey, page 8167, “Conclusion”) and improving versatility of the chip for detection of viral and bacterial pathogens (Coarsey, page 8167, “Conclusion”). Therefore, there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art to have arrived at the claimed invention. Additionally, note that applicant’s arguments regarding the combination of Selden and Coarsy (Remarks, page 13) are conclusory and are not persuasive.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bau et al. (US 20140162244 A1) teaches isolation and concentration of nucleic acids (abstract; [0009]). Bau teaches to simplify cassette operation, the extracted nucleic acid may be amplified in the isolation chamber without a separate step for the elution of the immobilized nucleic acids; and the utility of this integrated cassette was demonstrated by detecting HIV in oral fluids ([0009]).
Goel (US 20160016171 A1) teaches a system for extracting, amplifying, and detecting nucleic acids (abstract). Goel teaches beads retained within a chamber for subsequent amplification or eluting DNA from the beads prior to amplification ([0190]).
Agarwal et al. (US 20130302787 A1) teaches a device for extraction or isolation of an analyte such as a nucleic acid (abstract). Agarwal teaches an elution/processing chamber ([0150], elution/process chamber, i.e. third chamber, 36), wherein the processing chamber or elution chamber 36 is used for amplification and detection of a target nucleic acid ([0179]). Agarwal teaches elution buffer may be introduced into the third chamber ([0176]).
Zhao et al. (Zhao et al., “A simple magnetic nanoparticles-based viral RNA extraction method for efficient detection of SARS-CoV-2”, February 27, 2020, BioRxiv) teaches a chamber (Scheme 2; vial) for extraction and amplification (Scheme 2 and pages 6-7, section “Conventional Real-time…”, teaches a reaction solution as set up containing eluted supernatant; therefore, the setup of eluting and amplifying can be performed within a single chamber).
Kido (US 20070125942 A1) teaches an apparatus for disrupting, separating, and isolating biological materials (abstract). Kido teaches reagents for performing amplification of a nucleic acid can be included in the same chamber as the purification reagents or a different chamber; and elution fluid containing a target nucleic acid can, for example, contact PCR reagents contained in a reaction chamber for PCR amplification and detection ([0068]).
Cao et al. (US 20090215124 A1) teaches methods for purifying nucleic acids from a sample (Abstract). Cao teaches after elution, the purified nucleic acid may be amplified by PCR in the same chamber ([0051]).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY H NGUYEN whose telephone number is (571)272-2338. The examiner can normally be reached M-F 7:30A-5:00P.
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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.
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758
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