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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/20/2025 has been entered.
Response to Amendment
This is an office action in response to applicant's arguments and remarks filed on 11/20/2025. Claims 1-18 are pending in the application.
Status of Objections and Rejections
All rejections from the previous office action are withdrawn in view of Applicant's amendment.
New grounds of rejection under 35 U.S.C. 103 are necessitated by the amendments.
Response to Arguments
Applicant’s arguments with respect to claims 1-18 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-5 and 7-18 are rejected under 35 U.S.C. 103 as being unpatentable over Pais et al. (US 20190001325 A1).
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Annotated Fig. 4
Regarding claim 1, Pais et al. teaches a fluidic device (microfluidic device 401, see Fig. 4 and comprising:
a substrate (fluidic cartridge 405, see Fig. 4 and [0117]) comprising a plurality of fluid conduits built into fixed positions within the substrate, each fluid conduit including a first conduit portion separated from a second conduit portion and each fluid conduit being fluidically isolated from each other fluid conduit (see annotated Fig. 4, where the conduits are separated by camshaft 403, see [0117] – [0118]);
at least one transport body that is movably positioned to intersect each fluid conduit between the first conduit portion and the second conduit portion of each fluid conduit, wherein the at least one transport body has at least two different positions relative to the plurality of conduits (camshaft 403 is movable between the first and second conduit portions, see Fig. 4 and [0117] – [0118]), wherein the at least one transport body includes:
at least one port adapted to be aligned with a first conduit portion and a second conduit portion of at least one first conduit so as to fluidly couple the first conduit portion with the second conduit portion (slot 414 for aligning channel, see [0117] – [0118]);
at least one blocking body portion adapted to be aligned with a first conduit portion and a second conduit portion of at least one second conduit so as to fluidly isolate the first conduit portion from the second conduit portion of the at least one second conduit (see annotated Fig. 4, where when the slots are not linked to the channels, the conduits are isolated from each other, see [0117] – [0118]);
wherein the at least one transport body is movable relative to the plurality of conduits such that the at least one port is selectively alignable with the plurality of fluid conduits and the at least one blocking body portion is selectively alignable with the plurality of fluid conduits (the blocking portion of the camshaft and the slots 414 are rotatable to align to the channel 408, and are therefore selectively aligned, see [0117]-[0118]),
wherein each port of the at least one port aligns with one of the plurality of fluid conduits at a time (see Fig. 4 and [0117] – [0118]).
However, the current embodiment of Pais et al. does not teach that the device comprises at least one magnetic member magnetically associated with the at least one port, the at least one magnetic member attached to the transport body under the at least one port or embedded in the transport body and configured to move with the transport body.
However, a later embodiment of the invention teaches a comparable sample-to-answer device where it was known to use a rotatable actuator with magnetic members 703 embedded within each chamber of the rotatable shaft to spin and isolate magnetic particles for analysis, see Fig. 7, [0127], and [0164]. While the invention does not explicitly teach an embodiment where the inventions of Fig. 4 and Fig. 7 are used together, it was known that the magnetic and mechanical forms of actuation are usable together for providing an automated sample-to-answer platform, see [0044] and [0120].
Therefore, one of ordinary skill in the art before the effective filing date of the claimed invention would have recognized that the improvement of using a magnet to spin fluid located within a chamber taught by the later embodiment of the invention would have been capable of being applied to the transport body of the previous embodiment. Additionally, the results would have been predictable to one of ordinary skill in the art because the first embodiment of Pais et al. teaches that specific camshafts can be designed and built for a variety of different assays, see [0117], and is therefore ready for the improvement of magnetized fluidic chambers within the rotatable shaft for mixing and agitating fluid inside a fluidic chip.
2. (Original) The fluidic device of claim 1, wherein the magnetic member is configured to move with the at least one transport body to be magnetically associated with the at least one port of the at least one transport body at the at least two different positions relative to the plurality of conduits (the magnets 703 are located within the chamber and are therefore configured to move with the transport body and its associated ports at both locations, see Fig. 4 and Fig. 7).
Regarding claim 3, modified Pais et al. teaches the fluidic device of claim 1, wherein the at least one transport body includes the at least one magnetic member (modified cam shaft 403 contains magnets 703, see Fig. 4 and Fig. 7).
Regarding claim 4, modified Pais et al. teaches the fluidic device of claim 1, wherein a body having the plurality of conduits includes the at least one magnetic member (modified cam shaft 403 contains magnets 703, see Fig. 4 and Fig. 7, where the cam shaft is a part of the microfluidic cartridge 405).
Regarding claim 5, modified Pais et al. teaches the fluidic device of claim 1, wherein at least one substrate adjacent to the at least one transport body includes the at least one magnetic member (modified cam shaft 403 contains magnets 703, see Fig. 4 and Fig. 7, where the cam shaft is a part of the microfluidic cartridge 405, which is the substrate).
Regarding claim 7, modified Pais et al. teaches the fluidic device of claim 1, wherein the at least one transport body is adapted to be rotatable relative to the plurality of conduits to move between the at least two different positions relative to the plurality of conduits (the cam shaft 403 is rotatable to move between the positions between conduits, see Fig. 4).
Regarding claim 8, modified Pais et al. teaches the fluidic device of claim 1, wherein the magnetic member is a magnet, see [0127].
The difference between Pais et al. and the instant claims is that Reference A does not teach that the magnetic member is an electromagnet.
However, the difference between Reference A and the claimed invention was a known variation. Specifically, Reference A teaches that electromagnets can be used instead of permanent magnets within the microfluidic cartridges of the invention, see [0172].
Further, there were design incentives for implementing the claimed variation. Specifically, electromagnets may be pulsed alternatively, so as to achieve mixing and resuspension of the beads in a reaction well. Further, Pais et al. teaches that although the electromagnets require electric power supply and an electronic controller for switching ON and OFF, thus complicating the instrumentation requirements, the use of the electromagnets allows for the controlled sequencing of bead operations, as is the goal of the instant invention. Therefore, as of the effective filing date of the claimed invention, the use of electromagnets in the place of permanent magnets would have been recognized as predictable to one of ordinary skill in the art.
Regarding claim 9, modified Pais et al. teaches the fluidic device of claim 1, wherein the magnetic member is a permanent magnet (magnets 703 are permanent, see Fig. 7, [0066], and [0102]).
Regarding claim 10, modified Pais et al. teaches the fluidic device of claim 1, further comprising at least one actuator adapted to move the at least one transport body between the at least two different positions relative to the plurality of conduits (wind-up spring actuator for rotating the camshaft, see [0097] and [0117]).
Regarding claim 11, modified Pais et al. teaches the fluidic device of claim 1, further comprising at least one fluid reservoir for each conduit (reagent filled pouches 406, see annotated Fig. 4 and [0117]).
Regarding claim 12, modified Pais et al. teaches a kit (fluidic chip with fluid filled blisters 401, see Fig. 4) comprising:
the fluidic device of claim 1 (401, see annotated Fig. 4 and [0117]- [0118]); and
a plurality of magnetically-responsive particles (magnetic bead sample, see [0114], where the sample used in this example is the same as the previously referenced embodiment, see [0117]- [0119]).
Regarding claim 13, modified Pais et al. teaches the kit of claim 12, wherein the plurality of magnetically-responsive particles (magnetized beads, see [0114]), but does not specifically disclose that the beads include a capture agent on an external surface thereof.
However, the difference between Pais et al. and the claimed invention was a known variation. Specifically, Pais et al. teaches that the beads may be coupled with a biomolecule to provide an affinity for a target molecule, see [0183].
Further, there were design incentives for implementing the claimed variation. Specifically, DNA selectively binds to the functionalized surface of magnetic beads, see [0162], therefore the microfluidic chip would have applications in DNA analysis. Further, Reference A teaches that while some DNA molecules are attracted to magnets, pre-coupling the magnetized bead to another affinity probe would have the result of attaching the bead to an analyte of interest. Therefore, as of the effective filing date of the claimed invention, the use of pre-coupled beads with a biomolecule within the sample-to-answer cartridge would have been recognized as predictable to one of ordinary skill in the art.
Regarding claim 14, modified Pais et al. teaches the kit of claim 13, wherein the plurality of magnetically-responsive particles are magnetic (magnetic bead sample, see [0114]).
Regarding claim 15, Pais et al. teaches a fluidic device (microfluidic device 401, see Fig. 4 and comprising:
a substrate (fluidic cartridge 405, see Fig. 4 and [0117]) comprising a plurality of fluid conduits built into fixed positions within the substrate, each fluid conduit including a first conduit portion separated from a second conduit portion and each fluid conduit being fluidically isolated from each other fluid conduit (see annotated Fig. 4, where the conduits are separated by camshaft 403, see [0117] – [0118]);
at least one transport body that is movably positioned to intersect each fluid conduit between the first conduit portion and the second conduit portion of each fluid conduit, wherein the at least one transport body has at least two different positions relative to the plurality of conduits (camshaft 403 is movable between the first and second conduit portions, see Fig. 4 and [0117] – [0118]), wherein the at least one transport body includes:
at least one port adapted to be aligned with a first conduit portion and a second conduit portion of at least one first conduit so as to fluidly couple the first conduit portion with the second conduit portion (slot 414 for aligning channel, see [0117] – [0118]);
at least one blocking body portion adapted to be aligned with a first conduit portion and a second conduit portion of at least one second conduit so as to fluidly isolate the first conduit portion from the second conduit portion of the at least one second conduit (see annotated Fig. 4, where when the slots are not linked to the channels, the conduits are isolated from each other, see [0117] – [0118]);
wherein the at least one transport body is movable relative to the plurality of conduits such that the at least one port is selectively alignable with the plurality of fluid conduits and the at least one blocking body portion is selectively alignable with the plurality of fluid conduits (the blocking portion of the camshaft and the slots 414 are rotatable to align to the channel 408, and are therefore selectively aligned, see [0117]-[0118]),
wherein each port of the at least one port aligns with one of the plurality of fluid conduits at a time (see Fig. 4 and [0117] – [0118]).
However, the current embodiment of Pais et al. does not teach that the device comprises a magnetic means of retaining a particle in the at least one port while allowing a carrier fluid to flow from each port, the magnetic means configured to move with the at least one transport body.
However, a later embodiment of the invention teaches a comparable sample-to-answer device where it was known to use a rotatable actuator with magnetic members 703 embedded within each chamber of the rotatable shaft to promote sample mixing and . While the invention does not explicitly teach an embodiment where the inventions of Fig. 4 and Fig. 7 are used together, it was known that the magnetic and mechanical forms of actuation are usable together for providing an automated sample-to-answer platform, see [0044] and [0120].
Therefore, one of ordinary skill in the art before the effective filing date of the claimed invention would have recognized that the improvement of using a magnet to spin and isolate magnetic particles in fluid located within a chamber taught by the later embodiment of the invention would have been capable of being applied to the transport body of the previous embodiment. Additionally, the results would have been predictable to one of ordinary skill in the art because the first embodiment of Pais et al. teaches that specific camshafts can be designed and built for a variety of different assays, see [0117], and is therefore ready for the improvement of magnetized fluidic chambers within the rotatable shaft for mixing and agitating fluid inside a fluidic chip.
Regarding claim 16, modified Pais et al. teaches the fluidic device of claim 15, wherein the means of retaining a particle in the at least one port while allowing a carrier fluid to flow from each port is at least one blocking structure at least partially spanning a lateral cross-section of the at least one port (magnet 703 spans a cross section of the cylindrical cam shaft, see Fig. 7).
Regarding claim 17, modified Pais et al. teaches the fluidic device of claim 15, wherein the means of retaining a particle in the at least one port while allowing a carrier fluid to flow from each port is a member that permits flow of carrier fluid and blocks particles (magnet 703 captures magnetic particles to allow oil phase to pass through fluidic circuit, see Fig. 7 and [0160]- [0163]).
Regarding claim 18, modified Pais et al. teaches the fluidic device of claim 15, wherein the means of retaining a particle in the at least one port while allowing a carrier fluid to flow from each port is a magnetic member (magnet 703 captures magnetic particles to allow oil phase to pass through fluidic circuit, see Fig. 7 and [0160]- [0163]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Pais et al. (US 20190001325) as applied above, and further in view of Berndt et al. (US 20070154355).
Regarding claim 6, modified Pais et al. teaches the fluidic device of claim 1, wherein the at least one transport body is adapted to move between the at least two different positions relative to the plurality of conduits (see Fig. 4 and [0117] – [0118]), but does not teach that the transport body is adapted to be slidable relative to the plurality of conduits.
However, in the analogous art of microfluidic devices used to control the timing of reagent exposure, Berndt et al. teaches a microfluidic device 1 with a transport body (slider 21) configured to slide to match flow path 23 up to each of the plurality of conduits, see Fig. 1 and [0031] – [0032]. The modification of an auxiliary microfluidic insert with slots to slide to engage with a plurality of channels was therefore known in the art before the effective filing date of the instant invention as exemplified by Berndt et al.
Therefore, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the cam shaft of Pais et al. to slidably engage with the microfluidic platform, as exemplified by Berndt et al. for the benefit of transporting different reagent and sample mixes to each individual channel of the microfluidic device, see [0021] – [0023] in Berndt et al. The modification of Pais et al. to include the sliding motion of the transport body as exemplified by Berndt et al. would have had a reasonable expectation of successfully facilitating the controlled addition of fluids to a microfluidic platform, as is required by the instant invention.
Conclusion
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/A.N.M./ Examiner, Art Unit 1758
/SAMUEL P SIEFKE/ Primary Examiner, Art Unit 1758