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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/21/2026 has been entered.
Response to Amendment
The Amendment filed 01/07/2026 has been entered. Claims 1-3 and 5-15 remain pending in the application. Claims 9-15 are withdrawn. New grounds of rejections necessitated by amendments are discussed below.
Claim Objections
Claim 1 is objected to because of the following informalities: in line 26, it is suggested to recite “the plurality of sample” as “the plurality of samples”. Appropriate correction is required.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3 and 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Gubatayao (US 20140045186 A1; cited in the IDS) in view of Kreifels et al. (US 20160202184 A1).
Regarding claim 1, Gubatayao teaches a method (abstract) for detecting a target nucleic acid in a sample (abstract teaches nucleic acid detection), the method comprising:
(a) positioning a first sample set in a first reaction area of a nucleic acid reaction detection device (paragraph [0066] teaches a sample to be tested includes nucleic acid samples, which are delivered, i.e. positioned, to reaction chambers of the cartridge of the diagnostic apparatus, i.e. a nucleic acid reaction detection device; Figs. 3A and 6 and paragraph [0093] teaches rows and columns of reaction chambers 1703, with corresponding detectors 207, wherein one column of reaction chambers 1703 is interpreted as a first reaction area; the samples delivered to the column of reaction chambers are interpreted as a first sample set) and a second sample set in a second reaction area of the nucleic acid reaction detection device (paragraph [0066] teaches a sample to be tested includes nucleic acid samples, which are delivered, i.e. positioned, to reaction chambers of the cartridge of the diagnostic apparatus; Figs. 3A and 6 and paragraph [0093] teaches rows and columns of reaction chambers 1703, with corresponding detectors 207, wherein another column of reaction chambers 1703 is interpreted as a second reaction area; the samples delivered to the another column of reaction chambers are interpreted as a second sample set) and performing a nucleic acid reaction (paragraph [0066], “amplification reaction”; paragraph [0077] teaches each chamber performs independent amplification reactions);
wherein the nucleic acid reaction detection device comprising a sample reaction module comprising the first reaction area and the second reaction area thermally independent from each other (Fig. 3A and paragraph [0077] teaches chambers 1703 of a microfluidic cartridge, i.e. a sample reaction module, perform independent amplification reactions; Fig. 8 and paragraph [0101] teaches chambers 1703 are thermally controlled separately, where thermal units 1605 are thermally disconnected from one another; therefore, the columns of chambers are thermally independent from each other), an optical module comprising a light source and a detector (paragraph [0077], “detector head” that comprises a “light source-photodetector pair”; Fig. 6 teaches light sources 201 and photodetectors 207) configured to detect nucleic acid reaction of samples in the first reaction area and the second reaction area (paragraph [0077] teaches chambers performing independent amplification reactions and each chamber may receive light from a separate light source and be observed by a separate photodetector simultaneously, therefore the photodetectors are configured to detect nucleic acid reaction of samples in each column of chambers; paragraph [0093],[0096] teaches detectors that allow for detections of each column), and a controller (paragraphs [0012] and [0121], teach a computer processor); wherein temperatures of the first reaction area and the second reaction area are controlled according to different protocols (paragraph [0012] teaches a computer processor for performing protocols, such as simultaneously performing a plurality of thermal cycling reactions; paragraph [0102] teaches thermal units successively heat and/or cool their corresponding chamber in agreement with a protocol specified for each chamber, thus temperatures of the different columns of chambers, i.e. first and second reaction areas, are controlled according to different protocols; paragraphs [0114]-[0115] teach different protocols operating simultaneously in different reaction chambers, which includes different temperature/time contours in different reactors); wherein each of the first reaction area and the second reaction area comprises a plurality of receiving spaces, each receiving space being configured to receive a respective sample (Figs. 3A and 6 and paragraph [0093] teaches each column includes at least two reaction chambers 1703, i.e. receiving spaces; paragraph [0066] teaches a sample to be tested includes nucleic acid samples, which are delivered to reaction chambers);
wherein the sample reaction module (Fig. 3A and paragraph [0077] teaches chambers 1703 of a microfluidic cartridge) is configured so that each of the first reaction area and the second reaction area is capable of receiving a plurality of samples using the plurality of receiving spaces (Fig. 3A and 6 and paragraphs [0072],[0077] teaches each column of chambers 1703, i.e. first and second reaction area, having respective inlet ports and fluidic lanes; paragraph [0077] teaches detection of a plurality of target nucleic acids, i.e. a plurality of samples; paragraph [0066] teaches a sample to be tested includes nucleic acid samples, which are delivered to reaction chambers, i.e. receiving spaces; therefore, each chamber of each column is capable of receiving a plurality of samples via the inlet and fluidic lanes); and
wherein the optical module comprises a plurality of light sources (Fig. 6, light sources 201);
(b) measuring optical signals from the first sample set and the second sample set (paragraph [0077] teaches measuring reactions from the chambers, i.e. optical signals from the first and second sample sets in each chamber, using the detector head, where each column of chambers receive light from a separate light source and be observed by a separate photodetector simultaneously; paragraphs [0096], [0098] teaches detection of each column of reaction chambers); wherein the optical signals from the first sample set and the second sample set are measured synchronously (paragraphs [0042],[0077],[0093],[0098] teaches each column of chambers is observed simultaneously or concurrently, i.e. measured synchronously); wherein wavelength bands of the optical signals synchronously measured from the first sample set and the second sample set are different from each other (paragraph [0096] and Table 1 teach each column of detectors measure different wavelength bands; paragraph [0098] teaches a first column of emitters/detectors detects reaction chambers in second group of lanes and a second column of emitters/detectors detects reaction chambers in a first group of lanes, wherein paragraph [0097] teaches each column of emitter/detectors possess a minimal wavelength range overlap with its neighboring emitter/detector pair); wherein the first sample set comprises a plurality of samples (paragraph [0066] teaches a sample to be tested includes nucleic acid samples, which are delivered to reaction chambers; Figs. 3A and 6 and paragraph [0093] teaches rows and columns of reaction chambers 1703, wherein one column of reaction chambers 1703 is interpreted as a first reaction area; therefore, the column of reaction chambers, i.e. first sample set, comprises a sample in each chamber, i.e. a plurality of samples), and wherein measuring an optical signal from the first sample set positioned in the first reaction area is simultaneously measuring optical signals from the plurality of sample included in the first sample set (paragraphs [0042],[0077],[0093],[0098] teaches each column of chambers is observed simultaneously or concurrently; therefore, optical signals of the samples of each chamber of the column, i.e. plurality of sample in the first sample set in the first reaction area, is measured simultaneously); and
(c) detecting the target nucleic acid in the sample included in the first sample set and the second sample set by analyzing the measured optical signals (paragraph [0077] teaches observing reaction results from each reaction chamber, thus detecting of one or more target nucleic acids, which implies the detection of nucleic acid in the reaction chambers is by analyzing the measured optical signals; paragraph [0056] teaches detection of target amplicons in individual reaction chambers by detecting fluorescent emissions).
Gubatayao fails to teach: one of the plurality of light sources simultaneously radiates excitation light to the plurality of samples in one reaction area (Figs. 5-6 shows each light source radiating respective samples of a reaction area).
Kreifels teaches an improved device and system for polymerase chain reaction including a light source and detector, and simultaneously reading multiple light wavelengths (abstract). Kreifels teaches employing less hardware per sample and minimal hardware is required per sample such that the functionality of the components described herein is maximized over a wider number of samples, for example the instrument described herein may require only one light source (or one light source component) for multiple samples (paragraph [0016]). Kreifels teaches each sample block may have multiple light sources, with one or more light sources for each sample well or a shared light source among wells (e.g. one light source optically connected to two or more sample wells) (paragraph [0020]).
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 the plurality of light sources of Gubatayao to incorporate the teachings of minimizing hardware and a shared light source among wells of Kreifels (paragraphs [0016],[0020]) to provide: one of the plurality of light sources simultaneously radiates excitation light to the plurality of samples in one reaction area. Doing so would have a reasonable expectation of successfully minimizing hardware used to excite each sample of the reaction area as taught by Kreifels.
Furthermore, the claimed limitations are obvious because all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements (i.e. one light source radiating multiple samples) by known methods with no change in their respective functions (i.e. simultaneous excitation of each sample), and the combinations yielded nothing more than predictable results (i.e. providing one light source to radiate multiple samples in a reaction area would yield nothing more than the obvious and predictable result of enabling simultaneous excitation of each sample while minimizing hardware). See MPEP 2143(A).
Regarding claim 2, modified Gubatayao fails to explicitly teach wherein the step of measuring the optical signals (as discussed above; paragraphs [0077],[0097]-[0098]) further comprises a step of measuring an optical signal from one of the first sample set and the second sample set without measuring an optical signal from the other of the first sample set and the second sample set.
Gubatayao teaches an embodiment where two separate protocol profiles are performed simultaneously (Fig. 15A; paragraphs [0138]-[0139]). Gubatayao teaches a step of measuring an optical signal from one of the first sample set and the second sample set without measuring an optical signal from the other of the first sample set and the second sample set (Fig. 15A and paragraphs [0138]-[0139] teaches detection 3020a of protocol profile 3001, i.e. measuring optical signal from a first sample set, is at 30 seconds, where the second protocol 3005 is not measured at 30 seconds). Gubatayao teaches measuring optical signals from different protocols at different times, i.e. measuring one sample set without measuring the other sample set (Fig. 15A and paragraphs [0138]-[0139] teaches measurement times 3020a, 3020b of protocol 3001 do not coincide with measurement times 3030a, 3030b of protocol 3005). Gubatayao teaches protocols may introduce offset and duration extensions to achieve more efficient detection behavior (abstract). Gubatayao teaches due to time delay required for the detector head to scan across a chamber column with each of its columns of detector pairs, it is necessary to offset each of the protocols based on the location of the chamber in which they are execute (paragraph [0140]; Fig. 15B).
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 the method of measuring optical signals from the first sample set and the second sample set of modified Gubatayao to incorporate the teachings of measuring optical signals from different protocols at a different time of Gubatayao (Figs. 15A-15B; paragraphs [0138]-[0140]) to provide: the step of measuring the optical signals further comprises a step of measuring an optical signal from one of the first sample set and the second sample set without measuring an optical signal from the other of the first sample set and the second sample set. Doing so would have a reasonable expectation of successfully improving efficiency and optimization of detection of various different protocols as taught by Gubatayao (abstract; paragraph [0140]).
Regarding claim 3, Gubatayao further teaches wherein the measurement of an optical signal for the first sample set is performed by sequentially measuring optical signals of two or more different wavelength bands for the first sample set (paragraph [0097] teaches each column of emitter/detectors possess a minimal wavelength range overlap with its neighboring emitter/detector pair; paragraph [0098] teaches detection of the reaction chambers in the first column is performed using the first column of emitters/detector, and then detection of the reaction chambers in the first column is performed using the second column of emitters/detectors; therefore, the reaction chamber of the first column, i.e. first sample set, is sequentially measured, where at least two wavelengths are measured by the first and second columns of emitters/detectors, which emit/detect different wavelength ranges).
Regarding claim 5, Gubatayao further teaches wherein the controller operates the nucleic acid reaction detection device to perform an operation (paragraph [0012] teaches a computer processor for performing protocols, such as simultaneously performing a plurality of thermal cycling reactions in the reactors, thus the controller operates the cartridge of the diagnostic apparatus, i.e. the nucleic acid reaction detection device, to perform operations) comprising at least one of the steps of: (i) measuring an optical signal for one sample set of the first sample set and the second sample set without measuring an optical signal for the other sample set (interpreted as not required due to the “at least one of the steps” limitation); and (ii) synchronously measuring the optical signals from the first sample set and the second sample set (paragraph [0012] teaches a computer processor for performing protocols, such as detection steps; paragraphs [0042],[0077] teaches each chamber is observed simultaneously or concurrently, i.e. measured synchronously; Figs. 3A and 6 and paragraph [0093] teaches simultaneous detection of the chambers of each columns with multiple detectors 207; paragraph [0098] teaches a first column of emitters/detectors detects reaction chambers in second group of lanes and a second column of emitters/detectors detects reaction chambers in a first group of lanes), wherein the wavelength bands of the optical signals synchronously measured from the first sample set and the second sample set are different from each other (paragraph [0096] and Table 1 teach each column of detectors measure different wavelength bands; paragraph [0098] teaches a first column of emitters/detectors detects reaction chambers in second group of lanes and a second column of emitters/detectors detects reaction chambers in a first group of lanes, wherein paragraph [0097] teaches each column of emitter/detectors possess a minimal wavelength range overlap with its neighboring emitter/detector pair).
Regarding claim 6, Gubatayao further teaches wherein at least two of the plurality of light sources produce excitation lights of different wavelength bands from each other (paragraph [0096] teaches different light emitters corresponding to different dye/assay, i.e. excitation lights of different wavelength bands from each other; paragraph [0096] and Table 1 teach each column of detectors measure different wavelength bands; paragraph [0097] teaches each column of emitter/detectors possess a minimal wavelength range overlap with its neighboring emitter/detector pair, thus at least two emitters produce different excitation lights of different wavelength bands).
Regarding claim 7, Gubatayao further teaches wherein the optical module (Fig. 6) comprises a plurality of detectors (detectors 207), and wherein each of the plurality of detectors detects light emitted from the sample in a predetermined and fixed area of the sample reaction module (paragraph [0077] teaches where each chamber is observed by a separate photodetector simultaneously, i.e. detects light emitted from each sample of each chamber, wherein each chamber is interpreted as comprising a sample in a predetermined and fixed area of the cartridge, i.e. sample reaction module; paragraphs [0096], [0098] teaches detection of each column of reaction chambers; paragraph [0098] teaches a first column of emitters/detectors detects reaction chambers in second group of lanes and a second column of emitters/detectors detects reaction chambers in a first group of lanes).
Regarding claim 8, Gubatayao further teaches wherein the optical module (Fig. 6) comprises a plurality of detectors independently controlled (detectors 207; paragraph [0012] teaches a computer processor for performing protocols; paragraph [0094] teaches each detector pair is configured to independently detect a plurality of fluorescent moieties; paragraph [0098] teaches a process where a first column of emitters/detectors is controlled for detection, and then a next step where a second column of emitters/detectors is additionally controlled for detection; therefore, the detectors are independently controlled), wherein one or more different detectors among the plurality of detectors are assigned to each of the first reaction area and the second reaction area (Figs. 3A and 6 and paragraph [0093] teaches columns of reaction chambers 1703, with corresponding detectors 207 for simultaneous detection of the columns; therefore, the detectors are assigned to each column of chambers, i.e. reaction areas), and wherein optical signals are detected from the first sample set and the second sample set by the one or more different detectors assigned respectively (paragraph [0077] teaches chambers performing independent amplification reactions and each chamber is observed by a separate photodetector simultaneously, i.e. optical signals are observed; Figs. 3A and 6 and paragraph [0093] teaches columns of reaction chambers 1703, with corresponding detectors 207 for simultaneous detection of the columns; paragraph [0098] teaches detection of reaction chambers of each column).
Response to Arguments
Applicant’s arguments, see page 7, filed 01/07/2026, with respect to the claim objection have been fully considered and are persuasive. The claim objection of 08/22/2025 has been withdrawn.
Applicant’s arguments, see pages 7-10, filed 01/07/2026, with respect to the rejection(s) of claim 1 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Gubatayao (US 20140045186 A1; cited in the IDS) in view of Kreifels et al. (US 20160202184 A1).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Schmid et al. (EP 0953838 A1) teaches an apparatus (Fig. 1; abstract) comprising four reaction areas (vessel holders 11.1-11.4) each comprising twenty-four removable reaction-vessels (18). Schmid teaches the fluorescence measuring apparatus for simultaneously monitoring reactions taking place in a plurality of removable reaction vessels containing sample-reagent-mixtures apt to emit fluorescent light when illuminated by an excitation light (paragraph [0001]). Schmid teaches excitation light are transmitted to reaction liquids contained in reaction vessels 18 (paragraph [0019]). Schmid teaches monitoring signals of all vessels 18 are obtained in parallel, i.e. simultaneously (paragraph [0026]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY H NGUYEN whose telephone number is (571)272-2338. The examiner can normally be reached M-F 7:30A-5:00P.
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758