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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/17/2026 has been entered.
Response to Amendment
The Amendment filed 05/17/2026 has been entered. Claims 1-3 and 7-8 remain pending in the application. Applicant’s amendments to the specification and claims have overcome each and every objection and 112(b) rejections previously set forth in the Non-Final Office Action mailed 01/16/2026. New grounds of rejections necessitated by amendments are discussed below.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “wherein the excitation light source module further comprises a light source rotating device, which is configured to enable the PCB with a plurality of light emitting units to rotate“ (claim 1) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 Objections
Claim 3 is objected to because of the following informalities: It is suggested to include a comma after “claim 2” in line 1. 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 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Yu (CN 104677870 A; cited in the IDS 08/22/2022; see machine translation) in view of Kajihara et al. (US 20130034857 A1), Sun et al. (CN 102588818 A; see machine translation), Joseph et al. (US 20060030037 A1), and Kim et al. (US 20220228988 A1; effectively filed 05/31/2019).
Regarding claim 1, Yu teaches a polymerase chain reaction (PCR) detector (abstract and Figs. 2-5 teaches a ultra-miniaturized multi-channel real-time fluorescence spectrum detection device, which is structurally capable of being used for PCR detection), comprising an excitation light source module (Fig. 5, excitation light source 20), a chip device (sample cell 10) and a detection part (spectrum sensor 20), wherein the excitation light source module sends excitation light with a preset wavelength to the chip device (Fig. 5 and paragraph [0024] teaches the excitation light source generated excitation light to excite the sample cell with a wavelength; paragraph [0012]), and when performing an amplified reaction, the detection part (Fig. 5, spectrum sensor 40) is arranged at one side of a reaction bin of the chip device (Fig. 5 shows spectrum sensor 40 arranged at one side of a reaction bin of the sample cell 10);
the chip device comprises the reaction bin (Fig. 5 and paragraph [0025] teach sample cell 10 comprises a sample for a reaction, therefore comprises the reaction bin), in which a detected sample is contained (paragraph [0025]), wherein the detected sample is a nucleic acid fragment solution including a fluorescence mark (paragraph [0025] teaches a CNT sample and associated with a sample concentration, and sample target nucleic acid fragments and fluorescent substance);
the excitation light source module is configured to emit the excitation light (Fig. 5; paragraph [0025]), and the excitation light emitted by the excitation light source module is capable of illuminating the detected sample arranged in the reaction bin (Fig. 5; paragraph [0024]);
the excitation light source module is capable of emitting the excitation light of at least two different frequency bands at a same time (paragraphs [0012],[0030] teach the light source comprises a plurality of different selected excitation light sources of different frequency, thus is capable of emitting the excitation light of at least two different frequency bands at a same time);
wherein the reaction bin is arranged in an emitting direction of the excitation light of the excitation light source module (Fig. 5 shows a reaction bin or area of the sample cell 10 arranged in a direction of excitation light from light source 20), the detection part is arranged at the one side of the reaction bin (Fig. 5 shows spectrum sensor 40 arranged at one side of the reaction bin of the sample cell 10), and emitting light formed after the excitation light illuminates the reaction bin is capable of being detected by the detection part (Fig. 5 and paragraph [0026] teach fluorescence signal from the sample cell is collected and transmitted to the sensor 40); and the detection part is configured to detect the emitting light emitted by the detected sample in a vertical direction due to illumination of the excitation light (Fig. 5 shows the sensor 40 configured to detect emitted light in a vertical direction); and
the detection part comprises a spectrograph (paragraph [0028] teaches the multispectral sensor 40 detection multiple different wavelengths, therefore is a spectrograph), and the spectrograph is capable of detecting the excitation light and the emitting light (Fig. 5 teaches a multispectral sensor, which is structurally capable of detecting the excitation light and the emitting light; MPEP 2112.01(I));
wherein the excitation light source module includes at least one light emitting diode (paragraph [0012]); and
wherein the at least one light emitting diode is configured to emit the excitation light of at least two different frequency bands (paragraph [0012] teaches at least one excitation light to generate excitation light at different frequencies, the light source is a LED; paragraph [0030] teaches controllable frequency range of the excitation light and different selected excitation light sources of different frequencies).
Yu fails to teach:
the emitting direction of the excitation light is located below the detection part;
a wavelength scope of a spectrum detected by the spectrograph is 340-850 nm;
wherein the excitation light source module includes a printed circuit board (PCB) board, an optical fiber pump combiner, and at least one optical fiber corresponding to each light emitting diode;
wherein the light emitting diode is arranged at one side of the PCB, an optical fiber coupler is arranged at an output end of each light emitting diode, each optical fiber coupler is respectively coupled to one optical fiber, and the excitation light with the corresponding wavelength is coupled to the optical fiber through the optical fiber coupler and transmitted through the optical fiber;
wherein the optical fiber pump combiner arranges and combines various optical fibers integrally according to a preset method, and an optical fiber collimator is also arranged at an output end of the optical fiber pump combiner, so as to transform the excitation light in the optical fiber into collimating light;
wherein no mutually overlapped frequency scope is in a frequency scope of the excitation light of at least two different frequency bands;
wherein the excitation light source module further comprises a light source rotating device, which is configured to enable the PCB with a plurality of light emitting units to rotate.
Kajihara teaches an optical analysis apparatus including a light source, reaction areas, and a detection system for detecting light beams emitted from the reaction areas (Figs. 1-2; abstract). Kajihara teaches the apparatus is for a PCR apparatus (paragraph [0123]). Kajihara teaches an emitting direction of an excitation light is located below a detection part (Figs. 1-2) shows light sources 2 emits excitation light in an emitting direction which is located below detection system 6. Kajihara teaches a plurality of light sources for generating light beams having different wavelengths so that the optical analysis apparatus can be developed into an apparatus for multi-color detection (paragraph [0011]), and an optical analysis for different wavelengths can be carried out (paragraph [0032]). Kajihara teaches the detection system comprises a light detector, such as spectroscopic detector (paragraph [0061]). Kajihara teaches the detection wavelength is in a range of 300 to 800 nm (paragraph [0116]).
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 emitting direction or the detection part of Yu to incorporate the teachings of a detection system located above an emitting direction of excitation light of Kajihara (Figs. 1-2) to provide: the emitting direction of the excitation light is located below the detection part. Doing so would have a reasonable expectation of successfully positioning the excitation light or detection part in relation to each other for proper optical analysis of the chip device, as taught by Yu (Figs. 1-2). Additionally, doing so would be an obvious rearrangement of parts, wherein the particular placement of the excitation light or detection part is an obvious matter of design choice that would not have modified the operation of the detector (MPEP 2144.04(VI)(C)).
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 spectrograph of Yu to incorporate the teachings of detection wavelengths of Kajihara (paragraph [0116]) to provide: a wavelength scope of a spectrum detected by the spectrograph is 340-850 nm. Doing so would have a reasonable expectation of successfully detecting desired wavelength ranges to improve multi-color detection as taught by Kajihara (paragraph [0011]).
Modified Yu fails to teach:
wherein the excitation light source module includes a printed circuit board (PCB) board, an optical fiber pump combiner, and at least one optical fiber corresponding to each light emitting diode;
wherein the light emitting diode is arranged at one side of the PCB, an optical fiber coupler is arranged at an output end of each light emitting diode, each optical fiber coupler is respectively coupled to one optical fiber, and the excitation light with the corresponding wavelength is coupled to the optical fiber through the optical fiber coupler and transmitted through the optical fiber;
wherein the optical fiber pump combiner arranges and combines various optical fibers integrally according to a preset method, and an optical fiber collimator is also arranged at an output end of the optical fiber pump combiner, so as to transform the excitation light in the optical fiber into collimating light;
wherein no mutually overlapped frequency scope is in a frequency scope of the excitation light of at least two different frequency bands;
wherein the excitation light source module further comprises a light source rotating device, which is configured to enable the PCB with a plurality of light emitting units to rotate.
Kajihara teaches a plurality of light sources for generating light beams having different wavelengths so that the optical analysis apparatus can be developed into an apparatus for multi-color detection (paragraph [0011]). Kajihara teaches a plurality of fluorescent pigments, which are each excited at a specific one of different wavelengths in one of the reaction areas, each emit fluorescent light at the respective wavelength (paragraph [0062]).
Sun teaches a multi-spectrum compact LED light source system (abstract; Fig. 1). Sun teaches an excitation light source module (Fig. 1) comprises a PCB board (Fig. 1 and paragraph [0024], “control circuit module”, which is interpreted as a PCB board since it comprises control circuitry), an optical fiber pump combiner (Fig. 1 and paragraph [0024], element 5, which combines optical fibers 4), and at least one optical fiber corresponding to each light emitting diode (Fig. 1, optical fibers 4 which correspond to each LED 2); the light emitting diode (Fig. 1, LEDs 2) is arranged at one side of the PCB board (Fig. 1), an optical fiber coupler is arranged at an output end of each light emitting diode (Fig. 1, light coupling element 3 at an output end of each LED 2), each optical fiber coupler is respectively coupled to one optical fiber (Fig. 1 shows light coupling elements 3 coupled to respective optical fibers 4), and the excitation light with the corresponding wavelength is coupled to the optical fiber through the optical fiber coupler and transmitted through the optical fiber (Fig. 1; paragraph [0024]); the optical fiber pump combiner arranges and combines various optical fibers integrally according to a preset method (Fig. 1 shows element 5 arranges and combines optical fibers 4 integrally). Sun teaches direction different wavelengths of LED to a sample (Fig. 1; paragraph [0024]).
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 excitation light source module of modified Yu to incorporate the teachings of a multi-spectrum LED light source system for generating multiple different wavelengths to direct towards a sample of Sun (Fig. 1; paragraph [0024; abstract) and the teachings of plurality of light sources for generating light beams having different wavelengths so that the optical analysis apparatus can be developed into an apparatus for multi-color detection of Kajihara (paragraph [0011]) to provide: wherein the excitation light source module includes a printed circuit board (PCB) board, an optical fiber pump combiner, and at least one optical fiber corresponding to each light emitting diode; wherein the light emitting diode is arranged at one side of the PCB, an optical fiber coupler is arranged at an output end of each light emitting diode, each optical fiber coupler is respectively coupled to one optical fiber, and the excitation light with the corresponding wavelength is coupled to the optical fiber through the optical fiber coupler and transmitted through the optical fiber; wherein the optical fiber pump combiner arranges and combines various optical fibers integrally according to a preset method; and wherein no mutually overlapped frequency scope is in a frequency scope of the excitation light of at least two different frequency bands. Doing so would have a reasonable expectation of successfully utilizing known optical structures to improve multi-spectrum generation of different wavelengths to the sample and allow for multi-color detection.
Modified Yu fails to teach: an optical fiber collimator is also arranged at an output end of the optical fiber pump combiner, so as to transform the excitation light in the optical fiber into collimating light; wherein the excitation light source module further comprises a light source rotating device, which is configured to enable the PCB with a plurality of light emitting units to rotate.
Joseph teaches instruments for conducting chemical reactions (abstract), such as for amplification of nucleic acids (abstract). Joseph teaches the apparatus performs PCR (paragraph [0018]). Joseph teaches an optical excitation element as the source of excitation beams that encompasses optical sources that generate light beams of different wavelengths, which includes LEDs (paragraph [0072]). Joseph teaches optical transmission elements to collect and direct optical excitation sources to chips, wherein the optical transmission elements include optical fibers, multiplexers, and collimators (paragraph [0073]). Joseph teaches optical fibers and beam collimators connected to the excitation source are employed to illuminate the chip, wherein collimated beams provide uniform energy distribution across the chip (paragraph [0081]).
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 excitation light source module of modified Yu to incorporate the teachings of beam collimators of Joseph (paragraphs [0073],[0081]) to provide: an optical fiber collimator is also arranged at an output end of the optical fiber pump combiner, so as to transform the excitation light in the optical fiber into collimating light. Doing so would have a reasonable expectation of successfully improving control and direction of desired light beams from the excitation light source module and towards the chip.
Modified Yu fails to teach: wherein the excitation light source module further comprises a light source rotating device, which is configured to enable the PCB with a plurality of light emitting units to rotate.
Kim teaches a device for detecting light in reaction regions using a light detection device including a movable optical module for irradiating reaction regions with lights of a plurality of wavelengths, and detectors for detecting lights emitted from the reaction regions (abstract). Kim teaches the optical module is configured to be rotatable, where the light source units are rotated about a rotatable axis to change areas irradiated by the lights (paragraph [0080]). Kim teaches use of the optical module in which the light source units are rotated allows for efficient light detection not only when two reaction regions individually reach the light detection time but also when the two reaction regions simultaneously reach the light detection time (paragraph [0217]). Kim teaches distribution of light to a reaction region must be uniform (paragraph [0236]) and the light source wheel allows for a light source to radiate uniformly on the reaction region (paragraph [0238]).
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 excitation light source module of modified Yu to incorporate Kim’s teachings of a rotatable optical module rotate light source units for efficient light detection and uniform radiation of a reaction region (paragraphs [0080], [0217], [0236], [0238]) to provide: wherein the excitation light source module further comprises a light source rotating device, which is configured to enable the PCB with a plurality of light emitting units to rotate. Doing so would have a reasonable expectation of successfully improving control and positioning of the light emitting units to optimize and enhance efficiency and uniformity of light excitation and detection.
Note that the limitations of the excitation light source module and detection part are interpreted as functional limitations. Note that a functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the functional limitations, then it meets the claim. See MPEP 2114. The apparatus of modified Yu is identical to the presently claimed structure. Modified Yu discloses the excitation light source module, chip device and detection part as claimed and therefore, would have the ability to perform the use recited in the claim. See MPEP 2112.01 (I).
Regarding claim 2, Yu further teaches wherein the spectrograph detects the frequency band and intensity of the excitation light of at least two different frequency bands (interpreted as a functional limitation, see MPEP 2114; paragraph [0024] teaches the multispectral sensor 40 detects fluorescent signal intensity of different wavelength fluorescence, therefore is structurally capable of performing the functional limitation), and the emitting light caused by the excitation light illuminating the detection sample (interpreted as a functional limitation, see MPEP 2114; paragraph [0024] teaches the multispectral sensor 40 detects fluorescent signal intensity of different wavelength fluorescence, therefore is structurally capable of performing the functional limitation).
Note that the limitations of the spectrograph are interpreted as functional limitations. Note that a functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the functional limitations, then it meets the claim. See MPEP 2114. The apparatus of modified Yu is identical to the presently claimed structure. Modified Yu discloses the spectrograph as claimed and therefore, would have the ability to perform the use recited in the claim. See MPEP 2112.01 (I).
Claims 3 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Yu in view of Kajihara, Sun, Joseph, and Kim as applied to claim 1 above, and further in view of Jothikumar et al. (Jothikumar, P., Hill, V., & Narayanan, J. (2009). Design of FRET-TaqMan probes for multiplex real-time PCR using an internal positive control. BioTechniques, 46(7), 519–524).
Regarding claim 3, Yu further teaches wherein the frequency band of the excitation light of at least two different frequency bands at least comprises a first excitation light frequency band and a second excitation light frequency band (paragraphs [0012],[0030] teach the light source comprises a plurality of different selected excitation light sources of different frequency, thus comprises at least two excitation light frequency bands), and a frequency band of the emitting light caused by the excitation light of two different frequency bands at least comprises a first emitting light frequency band and a second emitting light frequency band (paragraph [0028] teaches fluorescence of different wavelengths are detected, thus comprises at least two emitting light frequency bands).
While Yu teaches more than two excitation light source to generate excitation light at different frequencies (paragraph [0012]), detection with different wavelength fluorescence intensity (paragraph [0027]), a plurality of fluorescent substance is excited to generate fluorescence of different wavelength (paragraph [0028]), and two excitation wavelength of the excitation light generated by the light source are different, when the sample cell contains multiple kinds of fluorescence, different excitation light can be excited to generate different fluorescence signal (paragraph [0030]), Yu fails to explicitly teach: no mutually overlapped frequency band scope is between any two of the first excitation light frequency band, the second excitation light frequency band, the first emitting light frequency band and the second emitting light frequency band.
Kajihara teaches a plurality of light sources for generating light beams having different wavelengths so that the optical analysis apparatus can be developed into an apparatus for multi-color detection (paragraph [0011]). Kajihara teaches a plurality of fluorescent pigments, which are each excited at a specific one of different wavelengths in one of the reaction areas, each emit fluorescent light at the respective wavelength (paragraph [0062]).
Jothikumar teaches a PCR instrument capable of multiplex real-time PCR assays using different fluorescent dyes (abstract). Jothikumar teaches FAM has an excitation at 495 nm and an emission at 520 nm; and Cy5.5 has a 690-nm excitation and a 705-nm emission (page 523, left column, first paragraph). Jothikumar teaches monitor dual fluorescence emissions through F1 (530 nm) and F3 (705 nm) channels without any spectral overlap in the respective monitoring channels for FAM and Cy5.5 (page 523, left column, first paragraph).
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 system of modified Yu to incorporate the teachings of multiplexing PCR assays using different fluorescent dyes that does not have spectrally overlapping emission and excitation wavelengths, such as FAM and CY5.5 of Jothikumar (abstract; page 523, left column, first paragraph), the teachings different excitation light can be excited to generate different fluorescence signal of different fluorescent substances of Yu (paragraphs [0012],[0027],[0028],[0030]), and the teachings of plurality of fluorescent pigments each excited at a specific different wavelengths each emitting fluorescent light at the respective wavelength of Kajihara (paragraph [0062]) to provide: no mutually overlapped frequency band scope is between any two of the first excitation light frequency band, the second excitation light frequency band, the first emitting light frequency band and the second emitting light frequency band. Doing so would have a reasonable expectation of successfully improving multiplexed excitation and detection of different fluorescence marks with mutually exclusive and distinguishable wavelength ranges.
Regarding claim 8, while Yu teaches a plurality of fluorescent substance is excited to generate fluorescence of different wavelength (paragraph [0028]), and two excitation wavelength of the excitation light generated by the light source are different, when the sample cell contains multiple kinds of fluorescence, different excitation light can be excited to generate different fluorescence signal (paragraph [0030]), Yu fails to explicitly teach: wherein the fluorescence mark is at least two of fam, hex, cy5 or cy5.5, wherein the detected sample of the cy5 and the cy5.5 cannot be detected at the same time, and the detected sample of the fam and hex cannot also be detected at the same time.
Kajihara teaches a plurality of light sources for generating light beams having different wavelengths so that the optical analysis apparatus can be developed into an apparatus for multi-color detection (paragraph [0011]). Kajihara teaches a plurality of fluorescent pigments, which are each excited at a specific one of different wavelengths in one of the reaction areas, each emit fluorescent light at the respective wavelength (paragraph [0062]).
Jothikumar teaches a PCR instrument capable of multiplex real-time PCR assays using different fluorescent dyes (abstract). Jothikumar teaches FAM has an excitation at 495 nm and an emission at 520 nm; and Cy5.5 has a 690-nm excitation and a 705-nm emission (page 523, left column, first paragraph). Jothikumar teaches monitor dual fluorescence emissions through F1 (530 nm) and F3 (705 nm) channels without any spectral overlap in the respective monitoring channels for FAM and Cy5.5 (page 523, left column, first paragraph).
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 fluorescence mark substance of modified Yu to incorporate the teachings of multiplexing PCR assays using different fluorescent dyes that does not have spectrally overlapping emission and excitation wavelengths, such as FAM and CY5.5 of Jothikumar (abstract; page 523, left column, first paragraph), the teachings different excitation light can be excited to generate different fluorescence signal of different fluorescent substances of Yu (paragraphs [0012],[0027],[0028],[0030]), and the teachings of plurality of fluorescent pigments each excited at a specific different wavelengths each emitting fluorescent light at the respective wavelength of Kajihara (paragraph [0062]) to provide: wherein the fluorescence mark is at least two of fam, hex, cy5 or cy5.5 (i.e. FAM, CY5.5), wherein the detected sample of the cy5 and the cy5.5 cannot be detected at the same time, and the detected sample of the fam and hex cannot also be detected at the same time. Doing so would have a reasonable expectation of successfully improving multiplexed excitation and detection of different fluorescence marks with mutually exclusive wavelength ranges.
Note that the limitations of “wherein the detected sample of the cy5 and the cy5.5 cannot be detected at the same time, and the detected sample of the fam and hex cannot also be detected at the same time” are interpreted as intended uses of the PCR detector. Note that an intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. The apparatus of modified Yu is identical to the presently claimed structure. Modified Yu discloses the spectrograph as claimed and therefore, would have the ability to perform the use recited in the claim. See MPEP 2112.01 (I).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Yu in view of Kajihara, Sun, Joseph, and Kim as applied to claim 1 above, and further in view of Floriano et al. (US 20080050830 A1).
Regarding claim 7, while Yu teaches a sample cell (Fig. 5, element 10), modified Yu fails to teach: wherein the chip device comprises a sample adding layer and a pipeline layer, which are arranged in turn from top to bottom, the sample adding layer comprises a sample adding hole and a reagent tube, the sample adding hole is configured to add a sample, and the reagent tube is configured to convey a buffer solution; the pipeline layer comprises the reaction bin, in which a freeze-dried reagent is embedded, the freeze-dried reagent comprises the fluorescence mark, and after being mixed, the sample and the buffer solution in the sample adding hole enter the reaction bin, so as to obtain the detected sample.
Floriano teaches an apparatus of detecting types of leukocytes in a sample (abstract), the apparatus comprising a cartridge including a plurality of layers coupled together (paragraph [0010]; Figs. 1-2). Floriano teaches the sample may be moved towards a region for polymerase chain reaction or a detection system (paragraph [0360]). Floriano teaches a chip device (Figs. 1-2) comprising a sample adding layer (Fig. 2, top layer 110) and a pipeline layer (channel layer 112), which are arranged in turn from top to bottom (Fig. 2), the sample adding layer (110) comprises a sample adding hole (120), the sample adding hole (120) is configured to add a sample (Fig. 2; paragraph [0132]); the pipeline layer comprises a reaction bin (Fig. 2, reagent regions 122), in which a freeze-dried reagent is embedded (paragraph [0120] teaches lyophilized reagents are positioned or coated on the reagent region). Floriano teaches reagents can include visualization agents (paragraph [0346]). Floriano teaches fluorescent dyes are used for detection of a sample (paragraph [0314]). Floriano teaches the fluid delivery system can include buffer reservoirs and syringes (paragraph [0087]). Floriano teaches a sample is mixed with buffer solutions in a collection region (paragraph [0126]). Floriano teaches a fluid delivery system delivers reagents to the detection system and facilitate transport of the sample from the sample collection region to the detection system (paragraph [0153]). Floriano teaches a layer comprising syringe tubes, i.e. reagent tube, to delivery fluids to the cartridge (paragraph [0205]; Fig. 26A), and an embodiment using a syringe pump, i.e. reagent tube, to push and pull fluids through the system, such as filling the system with a buffer (paragraph [0207]).
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 chip device of modified Yu to incorporate Floriano’s teachings of a chip comprising a sample adding layer and pipeline layer (Figs. 1-2), lyophilized reagents positioned in regions in the chip (paragraph [0120]), visualization agents and fluorescent dyes (paragraphs [0314],[0346]), a sample mixed with a buffer solution (paragraph [0126]), and the chip comprising a layer comprising syringes to push and full fluids through the system, such as a buffer (paragraphs [0205],[0207]; Fig. 26A) to provide: wherein the chip device comprises a sample adding layer and a pipeline layer, which are arranged in turn from top to bottom, the sample adding layer comprises a sample adding hole and a reagent tube, the sample adding hole is configured to add a sample, and the reagent tube is configured to convey a buffer solution; the pipeline layer comprises the reaction bin, in which a freeze-dried reagent is embedded, the freeze-dried reagent comprises the fluorescence mark, and after being mixed, the sample and the buffer solution in the sample adding hole enter the reaction bin, so as to obtain the detected sample. Doing so would have a reasonable expectation of successfully improving the chip device by incorporating known structures of analysis cartridges or chips for PCR detection as taught by Floriano, thus allowing for improved control of desired fluids, reagents, and sample for appropriate reactions to be performed for analysis.
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. the sample adding layer, pipeline layer, sample adding hole, reagent tube, reaction bin, freeze-dried reagent, fluorescent mark) by known methods with no change in their respective functions (i.e. allowing for introduction of a sample into a chip and allow for mixing of a sample with desired buffers and reagents in the chip), and the combinations yielded nothing more than predictable results (i.e. providing the claimed elements of the chip device would yield nothing more than the obvious and predictable result of improving control of desired fluids, reagents, and sample for appropriate reactions to be performed for analysis). See MPEP 2143(A).
Response to Arguments
Applicant’s arguments, see pages 7-8, filed 05/17/2026, with respect to the specification objections, claim objections, and rejections under 35 U.S.C. 112(b) have been fully considered and are persuasive. The specification objections, claim objections, and rejections under 35 U.S.C. 112(b) of 01/16/2026 have been withdrawn.
Applicant’s arguments, see pages 9-10, filed 05/17/2026, with respect to the rejection(s) of claims 1-3 and 7-8 under 35 U.S.C. 103, specifically regarding amended claim 1, 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 Yu (CN 104677870 A; cited in the IDS 08/22/2022; see machine translation) in view of Kajihara et al. (US 20130034857 A1), Sun et al. (CN 102588818 A; see machine translation), Joseph et al. (US 20060030037 A1), and Kim et al. (US 20220228988 A1; effectively filed 05/31/2019).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Nguyen et al. (US 20040166553 A1) teaches systems for detecting signals from assays (abstract). Nguyen teaches use of light sources, such as a laser coupled to a fiber-optic delivery system (paragraph [0389]). Nguyen teaches methods of measuring cells, such as PCR (paragraph [0479]). Nguyen teaches an illumination source can include light sources and a fiber optic bundle (paragraph [0521]), wherein for a non-uniform light source, samples or the light source can be rotated to ensure even exposure of all samples (paragraph [0521]).
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758
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