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 Group I, claims 1-13 in the reply filed on 11/18/25 is acknowledged. Group III claims 16-22 have been amended to now depend from claim 1 but are still directed to a different invention of a formulation of a liquid used to collect a saliva or nasal fluid. Claim 16 has recite a device including a formulation but the specification is silent regarding a device including a formulation. The specification states the formulation is a sample collection formulation or solution 16 (mouthwash/nasal spray or wash) which is not a device. Group III, claims 16-22 are still directed to a different invention and will not be examined due to restriction requirement filed 9/22/2025.
Claim Rejections - 35 USC § 102
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.
Claims 1-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Glezer et al. (US 2012/0178091).
Regarding claim 1, Glezer discloses a device (fig. 2a, 5b-7) comprising:
a sample port (21) or chamber (sample chamber 27) for receiving therein a sample-containing mixture containing therein a biological sample (the sample containing mixture containing a biological sample is not positively stated in the instant claims as it can be added to the device at a later time);
a solid-state membrane (membrane, para 115-116, fig. 3a discloses a membrane filter which captures a nucleic acid thereon) in fluid communication with the sample port or chamber (see fig. 2a and 3a; all the chambers and membrane are in fluid communication with each other as seen in fig. 2a and 3a) and configured to receive the sample-containing mixture therefrom, and allow the sample-containing mixture to pass across the membrane and capture nucleic acids in the biological sample on the membrane (this limitation does not further structurally limit the instant claim; the solid state membrane in the purification zone is in fluid communication with the sample port or chamber and receives the sample containing mixture; the membrane captures nucleic acid thereon; para 115-116);
a first pump (para 160, high volume and pressure diaphragm pump) in fluid communication with the solid-state membrane (see fig. 2a, 5b-7) and a waste chamber (see fig. 2a, waste chamber which is in fluid communication with all the ports and chambers) in fluid communication with the pump, wherein actuation of the first pump causes the sample containing mixture to flow across the solid-state membrane and into the waste chamber (the high volume and pressure diaphragm pump is structurally capable of performing this function and the first pump is connected to the sample inlet and is used to move fluid and air to the membrane and into the waste chamber);
an eluent chamber (lysis reagent chamber; one of the reagent chambers 26) configured to contain or containing an eluent therein (para 116);
an eluent reservoir (detection zone or PCR reaction zone or reconstitution chambers, any of these chambers receive the eluent from the membrane) in fluid communication with the solid-state membrane (purification zone having membrane therein); and
a second pump (linear actuator driving an air cylinder pump, para 160) in fluid communication with the solid-state membrane and the eluent chamber, wherein actuation of the second pump causes the eluent to flow from the eluent chamber across the solid-state membrane, elute captured nucleic acids from the solid-state membrane, and flow with the captured nucleic acids into the eluent reservoir (the eluent flows from the eluent chamber across the membrane and removes the captured nucleic acids from the membrane and transports them to the detection zone ; para 159-161, 170).
Regarding claim 2, device as defined in claim 1, wherein the first pump is a syringe containing a barrel and a plunger received within the barrel (para 177, air cylinder syringe), the barrel defines the waste chamber therein (empty chamber of syringe), and movement of the plunger draws or pulls the sample-containing mixture across the solid-state membrane and into waste chamber of the barrel.
Regarding claim 3, a device as defined in claim 2, wherein the second pump is movable between a non-actuated position and an actuated position (linear actuator driving an air cylinder pump, para 159-160), the eluent chamber includes a frangible or breakable wall (ampoule breaker, pump valve manifold is connected thereto) that is breakable by movement of the second pump between the non-actuated position and the actuated position to pump eluent from the eluent chamber across the solid-state membrane and into the eluent reservoir.
Regarding claim 4, a device as defined in claim 3, wherein the second pump is a plunger (para 90, syringe includes a plunger), movement of the plunger from the non-actuated position to the actuated position breaks the frangible or breakable wall of the eluent chamber and pushes the eluent across the solid-state membrane and into the eluent reservoir.
Regarding claim 5, a device as defined in claim 2, wherein the second pump is a syringe (para 90, syringe includes a plunger) including a barrel and a plunger received within the barrel (a syringe inherently includes a barrel and a plunger received within the barrel), and movement of the plunger pushes the eluent across the solid-state membrane and into the eluent reservoir (this limitation does not further structurally limit the instant claim).
Regarding claim 6, a device as defined in claim 1, further comprising a first one-way valve (para 146, solenoid valve controlled micro dispenser) in fluid communication between the sample port or chamber and the solid-state membrane and configured to allow the sample-containing mixture to flow in the direction from the sample port or chamber to the solid-state membrane.
Regarding claim 7, a device as defined in claim 1, further comprising a second valve (para 70 discloses a plurality of valves placed within the cartridge to control fluid flow within) in fluid communication between the solid-state membrane and the eluent reservoir and configured to allow fluid flow in the direction from the solid-state membrane into the eluent reservoir.
Regarding claim 8, a device as defined in claim 1, further comprising at least one reaction chamber (PCR reaction zone 23) and at least one conduit (see fig. 2a) in fluid communication between the eluent reservoir (reconstitution chambers) and the reaction chamber.
Regarding claim 9, a device as defined in claim 8, wherein the at least one conduit is a capillary conduit (para 71-73) configured to allow the eluent with captured nucleic acid to flow by capillary action through the capillary conduit and into the reaction chamber (this limitation does not further structurally limit the instant claims due to the conduit not having any dimension that would allow for capillary flow).
Regarding claim 10, a device as defined in claim 1, further comprising a plurality of reaction chambers (serpentine PCR reaction zone, having 4 chambers) and conduits in fluid communication between the eluent reservoir and each reaction chamber (See fig. 2a), wherein each conduit is configured to allow the eluent with captured nucleic acid to flow through the conduit and into the respective reaction chamber.
Regarding claim 11, a device as defined in claim 8, further comprising a valve (para 70 discloses a plurality of valves placed within the cartridge to control fluid flow within) in fluid communication between the reaction chamber and the ambient atmosphere, wherein the valve allows gas to flow from the reaction chamber into the ambient atmosphere, but prevents liquid flow therethrough.
Regarding claim 12, a device as defined in claim 8, further comprising a heating element (para 104, states a pre heating zone, a membrane heating zone) in thermal communication with the reaction chamber, wherein the heating element defines a first condition where the heating element heats the reaction chamber to an incubation temperature, and a second condition where the heating element does not heat the reaction chamber to the incubation temperature, and the heating element is configured to transition from the first condition to the second condition upon or following actuation of the second pump (this limitation does not further structurally limit the instant claims because the limitations are drawn to process steps. It is recommended to claim processor program limitations in order to positively claim the processor steps).
Regarding claim 13, the device as defined in claim 8, further comprising an optical sensor (para 73, optical fluid sensor 7a) configured to measure at least one of emission wavelength or intensity within the reaction chamber to detect at least one of a positive detection of a targeted nucleic acid or a negative detection of a targeted nucleic acid, and to transmit a signal to a user interface indicative thereof (the optical fluid sensor 7a is structurally capable of performing the above functional limitation).
Conclusion
Pertinent prior art:
US 9,132,398 Zhou is directed to a microfluidic device can comprise a microfluidic device body, wherein the microfluidic device body comprises a sample preparation area, a nucleic acid amplification area, a nucleic acid analysis area, and a network of fluid channels. Each of the sample preparation area, the nucleic acid amplification area and the nucleic acid analysis area are fluidly interconnected to at least one of the other two areas by at least one of the fluid channels. Using the microfluidic device, sample preparation can be combined with amplification of a biologically active molecule, and a suitable biological sample can be provided for analysis and/or detection of a molecule of interest. The small-scale apparatus and methods provided are easier, faster, less expensive, and equally efficacious compared to larger scale equipment for the preparation and analysis of a biological sample.
US 2022/0048026 Choy et al. discloses an apparatus includes a reaction-chamber circuit to process a reagent and a biologic sample for amplification of nucleic acids. The apparatus further includes a plurality of capillaries to pass the reagent and the biologic sample through the microfluidic reaction chamber. A valve control system may selectively control each of a plurality of valves to cause the reagent and the biologic sample to selectively move through the microfluidic reaction chamber for the amplification of the nucleic acids according to a particular timing sequence. In various examples, a trapping region disposed in the microfluidic reaction chamber secures the nucleic acids in the microfluidic reaction chamber for amplification using the reaction-chamber circuit.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL P SIEFKE whose telephone number is (571)272-1262. The examiner can normally be reached Monday, Tuesday, Thursday, Friday, 8-6.
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/SAMUEL P SIEFKE/Primary Examiner, Art Unit 1758