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 .
Election/Restrictions
Applicant’s election without traverse of Claims 1-13 in the reply filed on 1/7/2026 is acknowledged.
Claims 9-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/7/2026.
Claims 1-13 are pending examination in this response.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 5 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 recites “one magnetically active region positioned upstream of the optical inspection region”. This limitation is indefinite since claims 1 and 4 do not previously recite an order of operations other than “an optical analysis of the sample containing the eluted DNA/RNA previously captured on the magnetic beads” in claim 1, and it is unclear if “one magnetically active region” is referring to the location where the DNA/RNA is captured by the magnetic beads.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 1-4, 6, and 7 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Jovanovich et. al. (US 20150136602 A1).
Regarding claim 1, Jovanovich teaches “A chip for use in a real-time qPCR system” (Abstract and para [0269], The cartridge can comprise a fluidic manifold having macrofluidic chambers mated with microfluidic chips that route the liquids between chambers. This includes DNA extraction, qPCR.); “comprising: at least one port for receiving a sample into the chip; at least one channel in fluidic communication with the at least port: (Para [0035] In another aspect of the invention, provided herein is a device comprising: (a) a sample channel having a channel inlet and a channel outlet); “a plurality of magnetically active beads disposed within the at least one channel that capture DNA/RNA from the sample as the sample passes through the at least one channel” (Para [0181], [0225], and [0227], The chamber can be used to capture magnetic particles such as magnetic beads, paramagnetic beads, solid phase extraction material, monoliths, or chromatography matrices. The beads can be used to capture, concentrate, and then purify specific target antigens, proteins, carbohydrates, toxins, nucleic acids, cells, viruses, and spores. The beads can have a specific affinity reagent, typically an antibody, aptamer, or DNA that binds to a target. The devices of the invention can accommodate the use of magnetic beads. For example, beads or bead slurry can be supplied to a port of a cartridge. The beads can be mixed or suspended in solution within the cartridge using pumping, magnetic fields, or external mixers. The beads can then be pumped to desired chambers or reservoirs within the microfluidic device or cartridge. Beads can be captured within a chamber using a magnetic field.); “and an optical inspection region in fluidic communication with the at least one channel for performing an optical analysis of the sample containing the eluted DNA/RNA previously captured on the magnetic beads.” (Para [0024], and [0028] In another aspect, the invention provides an optical system comprising: (a) a plurality of optically transparent channels; (b) a light source configured to direct to the plurality of optically transparent channels; (c) a dispersive element that disperses light passing through the optically transparent channels in a wavelength dependent manner; and (d) a detector configured to receive the dispersed light. An optical sub-assembly configured to detect signal from the at least one separation channel.).
Regarding claim 2, Jovanovich teaches all of claim 1 as above in addition to “farther comprising at least one additional port for receiving at least one of wash fluid and elution fluid into the chip.” (Para [0155] and [0455], Valves in the microfluidic device can then be configured to route a volume, e.g., a non-microfluidic volume, of wash solution into the chamber. The solution is moved between the Elution valve and the Capture valve to facilitate mixing, ending with the solution in the Elution valve.).
Regarding claim 3, Jovanovich teaches all of claim 1 as above in addition to “further comprising at least one inlet corresponding to and in fluidic communication with the at least one port and located on a top surface of the chip.” (Para [0170] and [0175], (FIG. 3 and FIG. 4) the cartridge (1) can comprise one or more ports (4, 5, 6, 7, 8, 9) to external fluids, air, or vacuum. Functions of the ports can be for waste (4), reagent entry (5), vent (6), sample input (7), product output (8). The cartridge (1) can contain one or more sample input or reaction chambers, (7) and (3). Lead to channels in the cartridge (14, 15, 16, 17, 18, and 19) respectively.).
Regarding claim 4, Jovanovich teaches all of claim 1 as above in addition to “further comprising at least one magnetically active region configured to be magnetically active with the magnetically active beads.” (Para [0230], For example, the reaction module can comprise a chamber in communication with a magnetic force that is adapted to immobilize magnetically responsive particles on which the analyte is captured.).
Regarding claim 6, Jovanovich teaches all of claim 1 as above in addition to “further comprising at least one heated region.” (Para [0231], In one embodiment the temperature modulator uses a Peltier thermoelectric module external to the reaction channel to heat and cool the PCR reaction sample as desired.).
Regarding claim 7, Jovanovich teaches all of claim 6 as above in addition to “wherein one heated region is positioned on each side of the optical inspection region.” (Paras [0024], [0028], [0231], and [0035], An optical system comprising: (a) a plurality of optically transparent channels; (b) a light source configured to direct to the plurality of optically transparent channel. The temperature modulator uses a Peltier thermoelectric module external to the reaction channel to heat and cool the PCR reaction sample as desired. The reaction channel is clear or transparent.). Therefore, the heat region is on the sides of the reaction channels which are transparent channels and the optical system is directed to optically transparent channels.
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.
Claims 5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Jovanovich et. al. (US 20150136602 A1) in view of claim 4 as above and further in view of Chiu et. al. (WO 2019199499 A1).
Regarding claim 5, Jovanovich teaches all of claim 4 as above but does not explicitly teach “wherein one magnetically active region is positioned upstream of the optical inspection region.”.
Chui teaches systems, and devices for performing analyses of biological nanoparticles with magnetic element or field in addition to “wherein one magnetically active region is positioned upstream of the optical inspection region.”.(Para [0280], Flow may be regulated with one of the following either upstream or downstream of the detection volume: a valve, a bubble, an electric field, a magnetic field, an optical field).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine, through routine experimentation, to select the magnetically active region upstream the optical inspection region as Chui teaches both the magnetically active region and the optical inspection region can either be in the upstream or downstream location.
Regarding claim 8, Jovanovich teaches all of claim 1 as above but does not explicitly teach “further comprising at least one filter disposed within the at least one channel.”. However, Jovanovich does teach a separation channel and a standard/eluent input port within (Paras [0024 and [0455]).
Chui teaches “further comprising at least one filter disposed within the at least one channel.” (Paras [0039] and [0163] The device further comprises a filter. An apparatus provided herein may further comprise a filter. In a particular embodiment, the filter element may be in the form of microposts, microimpactors, microsieves, channels with apertures larger than bionanoparticles, channels with apertures such that a bionanoparticle may freely pass through the filter, but larger matter or debris in the fluid sample is blocked by the filter, microbeads, porous membranes, protrusions from the walls, adhesive coating, woven or non-woven fibers (such as cloth or mesh) of wool, metal.).
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 Jovanovich to incorporate the teachings of Chui wherein the chip has at least one filter disposed within the at least one channel. Doing so increases processing time, and decreases chances of clogging.
Claim 9 are rejected under 35 U.S.C. 103 as being unpatentable over Jovanovich et. al. (US 20150136602 A1) in view of claim 1 as above and further in view of Giri et. al. (WO 2016122645 A1).
Regarding claim 9, Jovanovich teaches all of claim 1 as above but does not explicitly teach “wherein the at least one channel is 0.5 mm deep and 0.5 mm wide.”. However, Jovanovinch does teach a 0.5 volume within the channel within (Para [0166], A cartridge reservoir or chamber can have a volume of at least about 0.1, 0.5, 1, 5, 10, 50, 100, 150, 200, 250, 300, 400, 500, 750, 1000, 2000, 3000, 4000, 5000 or more .mu.L. The relative volume of a chamber or reservoir can be about 1, 2, 5, 10, 20, 50, 100, 200, 500, 1000, 2000, 5000, 10000 or more greater than a channel or valve within the microfluidic microchip. The size of the chambers and reservoirs of the cartridge, which can be mated to the microfluidic microchip, can be chosen such that a large volume of sample, such as a sample greater than about 1, 5, 10, 50, 100, 500, 1000, 5000, 10000, 50000 or more .mu.L, can be processed.).
Giri teaches a fluid testing chip and cassette with magnetic beads in addition to “wherein the at least one channel is 0.5 mm deep and 0.5 mm wide.” (Para [0096], In the example illustrated, microfluidic reservoir has a mouth or top opening having a width W of less than 1 mm and nominally 0.5 mm. Reservoir 1030 has a depth D of between 0.5 mm and 1 mm and nominally 0.7 mm. As will be described hereafter, microfluidic chip 1030 comprises pumps and sensors along a bottom portion of chip 1030 in region 1033.).
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 Jovanovich to incorporate the teachings of Giri wherein the wherein the at least one channel is 0.5 mm deep and 0.5 mm wide. Doing so would increase robustness and reduce the chances of clogging.
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Jovanovich et. al. (US 20150136602 A1) in view of claim 1 as above and further in view of Wiktor et. al. (US 20160258944 A1).
Regarding claim 10, Jovanovich teaches all of claim 1 as above but does not explicitly teach “farther comprising at least one burst valve.” but does teach a safety mechanism within Para [0326].
Wiktor teaches a microreactor having fluid paths, magnetic beads, in addition to “comprising at least one burst valve” (Para [0089]- In some embodiments a burst valve may be substituted for or combined with the check valve 58 at the inlet port 50 to maintain vacuum before injecting the reagent 40. Pressure at the inlet port 50 may break the burst valve allowing reagent 40 to flow freely into the reagent gap 30 with minimal resistance. A hydrophobic restriction valve 60 at the outlet port 52 may prevent vacuum from sucking reagent 40 from the reagent gap 30 after filling the microreactors 24.).
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 Jovanovich to incorporate the teachings of Wiktor having at least one burst valve. Doing so allows the flow to stop without the use of a user interaction.
Regarding claim 11, Modified Jovanovich teaches all of claim 10 as above but does not explicitly teach “wherein the at least one burst valve is 0.1 mm deep and 0.1 mm wide.”. The specification does not indicate that the depth or width of the burst valve are critical. Without some showing of unexpected results, or statement of criticality, it would have been obvious to one of ordinary skill in the art to determine, through routine experimentation, an optimum depth and width for the burst valve would be determined.
Regarding claim 12, Jovanovich teaches all of claim 1 as above but does not explicitly teach “further comprising at least one chip stop disposed on and protruding from an exterior surface of the chip.”. Jovanovich does teach (Para [0231], Constriction components 709 and 701 can mate with additional constriction components 707 and 705 to facilitate pinching of the reaction channel.) which teaches to some connection component.
Wiktor teaches “further comprising at least one chip stop disposed on and protruding from an exterior surface of the chip.” (Para [0103] With reference to at least FIGS. 2 and 5, the microreactor array system 20 may further include a top 72 and one or more fasteners 74.)
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 Jovanovich to incorporate the teachings of Wiktor wherein the chip has at least one chip stop disposed on and protruding from an exterior surface of the chip. Doing so allows for a fast connection and removal of parts which increases versatility of the chip.
Claim 13 are rejected under 35 U.S.C. 103 as being unpatentable over Jovanovich et. al. (US 20150136602 A1) in view of claim 1 as above and further in view of Handique (US 20120122108 A1).
Regarding claim 13, Jovanovich teaches all of claim 1 as above but does not explicitly teach “further comprising an exit valve for discharging the sample from the chip”. However, Jovanovich teaches valves can be used to route volumes and waste can be removed from the chamber within (Para [0155], The paramagnetic particles can be held in the chamber by magnetic force and the uncaptured sample can be removed as waste, e.g., through a microfluidic channel. Valves in the microfluidic device can then be configured to route a volume, e.g., a non-microfluidic volume, of wash solution into the chamber. The analyte and particles can be washed, immobilized and the waste can be removed.)
Handique teaches microfluidic cartridges with magnetic particles in addition to “further comprising an exit valve for discharging the sample from the chip” (Para [0087], The microfluidic network is configured so that the time required for a microdroplet of sample to pass from the inlet to the second valve is less than 50% of the time required for the sample to travel up to the exit vent.).
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 Jovanovich to incorporate the teachings of Handique wherein the chip has an exit valve for discharging the sample from the chip. Doing so decreases contamination by decreasing the backflow of the fluids within the chip and channel.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VELVET E HERON whose telephone number is (571)272-1557. The examiner can normally be reached M-F.
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/V.E.H./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798