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 in the reply filed on 10/14/2025 is acknowledged. Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 05/19/2023, 08/02/2023, 11/03/2025, 03/02/2026 and 03/10/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 1-7 and 9-21 are pending with claims 1-7, 9-10 and 21 being examined, claims 11-20 are deemed withdrawn. Claim 8 is canceled.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “106” has been used to designate both outlet and the heating element. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-2 and 5 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”).
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 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 to measure the fluorescence measurements.
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.
Regarding claim 5, 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 further includes one or more microwells, wherein the microwells have dimensions of at about 116 micrometers (pm) by about 116 pm.
However, Barany teaches the analogous art of pathogen detection (Barany; [0033]) that includes micro-wells (Barany; [0022] “an array of a plurality of micro-wells”) wherein the microwells have dimensions of at about 116 micrometers (pm) by about 116 pm (Barany; [0146] “micro-wells may be 50 micron diameter”).
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 device as taught by Barany because Barany teaches a pathogen detection device (Barany; [0033]) that includes micro-wells (Barany; [0022] “an array of a plurality of micro-wells”), wherein the microwells have dimensions of at about 116 micrometers (pm) by about 116 pm (Barany; [0146] “micro-wells may be 50 micron diameter”).
The modification allows to provide more vivo-like microenvironments.
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over
Hansen, Handler, and Barany 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, 10 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Barany (US 20200038871 A1; hereinafter “Barany”), 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 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 cartridge (detection device) for processing a biological sample (Handler; Title) that includes an imaging system (Handler; fig. 10. 51) and an excitation source (Handler; fig. 10. 52) that excites the solution (Handler; fig. 10 and what appears to be a fluorescent probe (Handler; [0027]); and detect, via a fluorescence detection system (Handler; [0087] “optical means for fluorescence detection of the detection device”), an emission of the one or more fluorescence dyes (Handler; [0027]).
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 include an excitation source of an imaging system of the detection system, the solution; and detect, via a fluorescence detection system of the detection device, an emission of the one or more fluorescence dyes as taught by Handler because Handler teaches a cartridge (detection device) for processing a biological sample (Handler; Title) that includes an imaging system (Handler; fig. 10. 51) and an excitation source (Handler; fig. 10. 52) that excites the solution (Handler; fig. 10 and what appears to be a fluorescent probe (Handler; [0027]); and detect, via a fluorescence detection system (Handler; [0087] “optical means for fluorescence detection of the detection device, an emission of the one or more fluorescence dyes (Handler; [0027]).
The modification allows to enhance detection of the nucleic acids.
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 10, modified Barany teaches the device of claim 6 (see above), wherein the detection device further includes one or more microwells (Barany; [0022] “an array of a plurality of micro-wells”), wherein the microwells have dimensions of at about 116 micrometers (pm) by about 116 pm (Barany; [0146] “micro-wells may be 50 micron diameter”).
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”) in view of Handler et al. (US 20040141880 A1; hereinafter “Handler” already of record), further in view of 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.
Conclusion
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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