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 .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/23/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 1-4, 6-7 and 9 and 11-21 are pending with claims 1-4, 6-7, 9 and 21 being examined and claims 11-20 are withdrawn. Claims 5, 8 and 10 are canceled.
Response to Amendments
Applicant’s arguments, filed on 07/08/2026, along with the amendments have been fully considered and are persuasive.
The drawing objection is withdrawn. Applicant amended the specification to correct the heating element to be element 110 in figure 1.
As to the arguments and remarks, the Examiner has found Applicant’s arguments not persuasive. The previous rejection has been modified in accord with the amendment.
Claims 1 and 2 are rejected under 35 U.S.C. 103 as being unpatentable over
Hansen et al. (US 20200332357 A1; hereinafter; “Hansen” already of record), in view of Handler et al. (US 20040141880 A1; hereinafter “Handler” already of record), further in view of Barany (US 20200038871 A1; hereinafter “Barany” already of record) and Halverson et al. (US 20160025637 A1; hereinafter “Halverson”).
Regarding claim 1, Hansen teaches a system for pathogen detection (Hansen; [0184] “the system can be used to analyze bacteria cells”) comprising:
a pathogen detection device (Hansen; fig. 5 and [0028]) comprising:
an inlet (Hansen; fig. 46B (I));
an outlet (Hansen; [0091 “each chamber will have an outlet”); and
a reactive chamber (Hansen; fig. 2A. 31);
an imaging system (Hansen; [0193] “the system comprises an imaging device”).
Hansen fails to teach the reactive chamber having one or more square microwells, wherein the one or more square microwells have dimensions of about 116 micrometers (pm) by about 116 pm.
However, Halverson teaches the analogous art of a device for pathogen detection (Halverson; [0077]-[0078]) that includes a reactive chamber (Halverson; fig. 2A, 200) having one or more square microwells (Halverson; fig. 2. 222, and [094] “the wells can be square”) wherein the one or more square microwells have dimensions of about 116 micrometers (pm) by about 116 pm (Halverson; [0099]).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Hansen’s reactive chamber to include one or more square microwells having dimensions of about 116 micrometers (pm) by about 116 pm as taught by Halverson because Halverson teaches a device for pathogen detection (Halverson; [0077]-[0078]) that includes a reactive chamber (Halverson; fig. 2A, 200) having one or more square microwells (Halverson; fig. 2. 222, and [094] “the wells can be square”) wherein the one or more square microwells have dimensions of about 116 micrometers (pm) by about 116 pm (Halverson; [0099]).
The modification allows the introduction of the necessary reactants into the wells (Halverson; [0089]).
Hansen fails to teach the imaging system comprises: an excitation source; and
a fluorescence detection system ;a substrate; and a heating element;
excite, via the excitation source of the imaging system, the solution and the probe; and detect, via the fluorescence detection system, an emission of the one or more fluorescence dyes.
However, Handler teaches the analogous art of a system for processing a biological sample (Handler; Title) that includes an imaging system (Handler; fig. 10. 51) wherein the imaging system comprises an excitation source (Handler; fig. 10. 52), and a fluorescence detection system (Handler; [0027]); a substrate (Handler; [0002]); and a heating element (Handler; fig. 2. 38).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Hansen’s imaging system to include an excitation source, a fluorescence detection system, a substrate and a heating element as taught by Handler because Handler teaches an imaging system (Handler; fig. 10. 51) wherein the imaging system comprises an excitation source (Handler; fig. 10. 52), and a fluorescence detection system (Handler; [0027]); a substrate (Handler; [0002]); and a heating element (Handler; fig. 2. 38).
The modification allows for imaging and measuring fluorescence generated (Handler; [0027]).
Hansen fails to teach wherein the pathogen detection system is configured to: receive, at the inlet of the pathogen detection device, a solution containing at least one of DNA or RNA;
route the solution to the reactive chamber of the pathogen detection device;
heat, via the heating element, the solution; receive, at the inlet of the pathogen detection device, at least one of a DNA or RNA probe, the probe containing one or more fluorescence dyes
However, Barany teaches the analogous art of pathogen detection (Barany; [0033]) that includes a cartridge (device) (Barany; fig. 3. 104) that includes an inlet (Barany; fig. 3. 102), wherein the pathogen detection system is configured to receive, at the inlet of the pathogen detection device, a solution containing at least one of DNA or RNA; route the solution to the reactive chamber of the pathogen detection device (Barany; [0296] “fluid enters through inlet 104”, and [0022] “inlet receives material to identify nucleic acids”, “wherein the cartridge defines a reaction chamber”); heat, via the heating element, the solution (Barany; [0107]) ; receive, at the inlet of the pathogen detection device, at least one of a DNA or RNA probe (Barany; [0028]).
Barany does not explicitly teach the probe contains one or more fluorescence dyes. Barany teaches a process of identifying nucleic acid molecules [0027] wherein the nucleic acid molecules are copied onto the immobilized capture probes (Barany; [0028]) wherein the probes comprise a fluorescent group (Barany; [0027]).
It would have been obvious to include one or more fluorescent dues to the nucleic acid probe in order to enhance detection of the nucleic acids.
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Hansen’s pathogen detection system to receive, at the inlet of the pathogen detection device, a solution containing at least one of DNA or RNA; route the solution to the reactive chamber of the pathogen detection device; heat, via the heating element, the solution; receive, at the inlet of the pathogen detection device, at least one of a DNA or RNA probe as taught by Barany because Barany teaches pathogen detection (Barany; [0033]) that includes a cartridge (device) (Barany; fig. 3. 104) that includes an inlet (Barany; fig. 3. 102), wherein the pathogen detection system is configured to receive, at the inlet of the pathogen detection device, a solution containing at least one of DNA or RNA; route the solution to the reactive chamber of the pathogen detection device (Barany; [0296] “fluid enters through inlet 104”, and [0022] “inlet receives material to identify nucleic acids”, “wherein the cartridge defines a reaction chamber”); heat, via the heating element, the solution (Barany; [0107]) ; receive, at the inlet of the pathogen detection device, at least one of a DNA or RNA probe (Barany; [0028]).
The modification allows to denature the double helix structure for amplification.
Regarding claim 2, Modified Hansen teaches the system of claim 1 (see above) to include a heating element (see above).
Modified Hansen fails to teach the heating element includes at least one of: a Peltier device; a heating block; a thermal electric cooling device; a hot plate; or a resistive heater.
However, Barany teaches the analogous art of pathogen detection (Barany; [0033]) that includes a heating element (Barany; [0039] “heating element that allows for thermocycling”) wherein the heating element includes a thermal electric cooling device (Barany; [0211] “heating elements to provide heating/cooling”).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Hansen’s heating element to includes at least one of a Peltier device; a heating block; a thermal electric cooling device; a hot plate; or a resistive heater as taught by Barany because Barany teaches pathogen detection (Barany; [0033]) that includes a heating element (Barany; [0039] “heating element that allows for thermocycling”) wherein the heating element includes a thermal electric cooling device (Barany; [0211] ‘heating elements to provide heating/cooling”).
The modification allows to perform temperature cycling that is essential for DNA amplification.
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over
Hansen, Handler, Barany and Halverson as applied to claim 1, further in view of Woolley et al. (US 10597289 B1; hereinafter “Woolley” already of record).
Regarding claim 3, modified Hansen teaches the system of claim 1 (see above) to include a detection device (see above).
Modified Hansen fails to teach the pathogen detection device is manufactured using three-dimensional (3D) printing.
However, Woolley teaches the analogous art of manufacturing 3D microfluidic (detection) device printing (Woolley; Abstract) wherein the detection device is manufactured using three-dimensional (3D) printing (Woolley; Abstract).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Hansen’s detection device to be manufactured using three-dimensional (3D) printing as taught by Woolley because Woolley teaches manufacturing 3D microfluidic (detection) device printing (Woolley; Abstract) wherein the detection device is manufactured using three-dimensional (3D) printing (Woolley; Abstract).
The modification provides the ability to produce a detection device with complex geometries.
Regarding claim 4, modified Hansen teaches the system of claim 1 (see above) to include a pathogen detection device (see above).
Modified Hansen fails to teach the pathogen detection device comprises a resin, the resin comprising: poly(ethylene glycol) diacrylate (PEGDA); bis(2,4,6-trimethylbenzoyl)-phenylphosphineoxide (Irgacure 819); and avobenzone.
However, Woolley teaches the analogous art of manufacturing 3D microfluidic (detection) device printing (Woolley; Abstract) wherein the detection device comprises a resin (Woolley; Title), the resin comprising: poly(ethylene glycol) diacrylate (PEGDA); bis(2,4,6-trimethylbenzoyl)-phenylphosphineoxide (Irgacure 819) (Woolley; Col. 20 lines 59-66), and avobenzone (Woolley; Col. 7 line 14).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Hansen’s detection device to comprises a resin, the resin comprising: poly(ethylene glycol) diacrylate (PEGDA); bis(2,4,6-trimethylbenzoyl)-phenylphosphineoxide (Irgacure 819); and avobenzone as taught by Woolley because Woolley teaches of manufacturing 3D microfluidic (detection) device printing (Woolley; Abstract) wherein the detection device comprises a resin (Woolley; Title), the resin comprising: poly(ethylene glycol) diacrylate (PEGDA); bis(2,4,6-trimethylbenzoyl)-phenylphosphineoxide (Irgacure 819) (Woolley; Col. 20 lines 59-66), and avobenzone (Woolley; Col. 7 line 14).
The modification allows for control over material formation as PEGDA is easily malleable.
Claims 6-7 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Barany (US 20200038871 A1; hereinafter “Barany” already of record), in view of Halverson et al. (US 20160025637 A1; hereinafter “Halverson”), further in view of Handler et al. (US 20040141880 A1; hereinafter “Handler” already of record).
Regarding claim 6, Barany teaches a device (Barany; [0022] “system”) comprising:
a detection device (Barany; [0022] “the system comprises a cartridge”) configured to:
receive, at an inlet (Barany; fig. 3. 102) of the detection device, a solution containing at least one of DNA or RNA (Barany; [0171] “the contacted sample is blended with a one or more oligonucleotides primer sets”);
route the solution to a reactive chamber of the detection device (Barany; [0164] “aqueous solution comprising target, PCR primers, moved into the reaction chamber”);
heat, via a heating element, the solution (Barany; [0164] “after the PCR thermocycling step”);
receive, at the inlet of the detection device, at least one of a DNA or RNA probe (Barany; [0296] “fluid enters through inlet 104”).
Barany does not explicitly teach the probe contains one or more fluorescence dyes. Barany teaches a process of identifying nucleic acid molecules [0027] wherein the nucleic acid molecules are copied onto the immobilized capture probes (Barany; [0028]) wherein the probes comprise a fluorescent group (Barany; [0027]).
It would have been obvious to include one or more fluorescent dyes in the nucleic acid probe in order to enhance detection of the nucleic acids.
Barany fails to teach wherein the reactive chamber includes one or more square microwells having dimensions of about 116 micrometers (pm) by about 116 pm.
However, Halverson teaches the analogous art of a device for pathogen detection (Halverson; [0077]-[0078]) that includes a reactive chamber (Halverson; fig. 2A, 200) having one or more square microwells (Halverson; fig. 2. 222, and [094] “the wells can be square”) wherein the one or more square microwells have dimensions of about 116 micrometers (pm) by about 116 pm (Halverson; [0099]).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Hansen’s reactive chamber to include one or more square microwells having dimensions of about 116 micrometers (pm) by about 116 pm as taught by Halverson because Halverson teaches a device for pathogen detection (Halverson; [0077]-[0078]) that includes a reactive chamber (Halverson; fig. 2A, 200) having one or more square microwells (Halverson; fig. 2. 222, and [094] “the wells can be square”) wherein the one or more square microwells have dimensions of about 116 micrometers (pm) by about 116 pm (Halverson; [0099]).
The modification allows the introduction of the necessary reactants into the wells (Halverson; [0089]).
Barany fails to teach exciting, via an excitation source of an imaging system of the detection system, the solution and the probe; and
detect, via a fluorescence detection system of the detection device, an emission of the one or more fluorescence dyes.
However, Handler teaches the analogous art of a system for processing a biological sample (Handler; Title) that includes an imaging system (Handler; fig. 10. 51) wherein the imaging system comprises an excitation source (Handler; fig. 10. 52), and a fluorescence detection system (Handler; [0027]); a substrate (Handler; [0002]); and a heating element (Handler; fig. 2. 38).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Hansen’s imaging system to include an excitation source, a fluorescence detection system, a substrate and a heating element as taught by Handler because Handler teaches an imaging system (Handler; fig. 10. 51) wherein the imaging system comprises an excitation source (Handler; fig. 10. 52), and a fluorescence detection system (Handler; [0027]); a substrate (Handler; [0002]); and a heating element (Handler; fig. 2. 38).
The modification allows for imaging and measuring fluorescence generated (Handler; [0027]).
Regarding claim 7, modified Barany teaches the device of claim 6, wherein the heating element (Barany; [0069] “heating element”) includes at least one of: a Peltier device; a heating block; a thermal electric cooling device; a hot plate; or a resistive heater (Barany; [0211] heating elements to provide heating/cooling”).
Regarding claim 21, modified Barany teaches the device of claim 6 (see above), wherein the at least one of the DNA or the RNA includes synthetic DNA or synthetic RNA (Barany; [0130] process of identifying a plurality of nucleic acid molecules, wherein the product is amplified).
It is well known in the art that amplified nucleic acids are considered synthetic nucleic acids.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Barany (US 20200038871 A1; hereinafter “Barany” already of record) in view of Halverson et al. (US 20160025637 A1; hereinafter “Halverson”), further in view of Handler et al. (US 20040141880 A1; hereinafter “Handler” already of record), and Woolley et al. (US 10597289 B1; hereinafter “Woolley” already of record).
Regarding claim 9, modified Barany teaches the device of claim 6 (see above) to include a detection device (see above).
Modified Barany fails to teach the detection device comprises a resin, the resin comprising: poly(ethylene glycol) diacrylate (PEGDA);bis(2,4,6-trimethylbenzoyl)-phenylphosphineoxide (Irgacure 819); and avobenzone.
However, Woolley teaches the analogous art of manufacturing 3D microfluidic (detection) device printing (Woolley; Abstract) wherein the detection device comprises a resin (Woolley; Title), the resin comprising: poly(ethylene glycol) diacrylate (PEGDA); bis(2,4,6-trimethylbenzoyl)-phenylphosphineoxide (Irgacure 819) (Woolley; Col. 20 lines 59-66), and avobenzone (Woolley; Col. 7 line 14).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Barany’s detection device to comprises a resin, the resin comprising: poly(ethylene glycol) diacrylate (PEGDA); bis(2,4,6-trimethylbenzoyl)-phenylphosphineoxide (Irgacure 819); and avobenzone as taught by Woolley because Woolley teaches of manufacturing 3D microfluidic (detection) device printing (Woolley; Abstract) wherein the detection device comprises a resin (Woolley; Title), the resin comprising: poly(ethylene glycol) diacrylate (PEGDA); bis(2,4,6-trimethylbenzoyl)-phenylphosphineoxide (Irgacure 819) (Woolley; Col. 20 lines 59-66), and avobenzone (Woolley; Col. 7 line 14).
The modification allows for control over material formation as PEGDA is easily malleable.
Response to Arguments
Applicant’s arguments with respect to claims 1-4, 6-7, 9 and 21 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.
Conclusion
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 ALEX RAMIREZ whose telephone number is (571)272-9756. The examiner can normally be reached Monday - Friday 8:00 - 5:00.
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/A.R./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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