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 .
Response to Amendment
The Amendment filed 11/21/2025 has been entered. Claims 1-3 and 7-13 remain pending in the application. Claims 9-13 are withdrawn.
Specification
The disclosure is objected to because of the following informalities: It is suggested to recite the terms PCR (specification, paragraph [0001]), LED (paragraph [0004]), PCB (paragraph [0018]), and LD (paragraph [0025]) in an unabbreviated form to establish the acronym.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: It is suggested to recite “PCR” in line 1 in an unabbreviated form to establish the acronym. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: It is suggested to recite “the PCB board” in line 25 as “the PCB”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3 and 7-8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, claim 1 recites the limitation "the optical fiber collimator" in line 31. There is insufficient antecedent basis for this limitation in the claim. Claims 2-3 and 7-8 are rejected by virtue of their dependency on claim 1.
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) and Joseph et al. (US 20060030037 A1).
Regarding claim 1, Yu teaches a 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); and 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 the 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 the 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 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 the 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 the 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 340-850nm;
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 board, 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 the 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; and
wherein no mutually overlapped frequency scope is in the frequency scope of the excitation light of at least two different frequency bands.
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 340-850nm. 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 board, 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 the 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; and
wherein no mutually overlapped frequency scope is in the frequency scope of the excitation light of at least two different frequency bands.
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 board, 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 the 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: the 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.
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: the 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.
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 spectrograph detects the frequency band and intensity of the excitation light of at least two different frequency bands 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, and Joseph 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 the 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 and cy5.5, wherein the detected sample of the cy5 and 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 and cy5.5 (i.e. FAM, CY5.5), wherein the detected sample of the cy5 and 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 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, and Joseph 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 a 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 a 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 page 8, filed 11/21/2025, 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 08/29/2025 have been withdrawn.
Applicant's arguments, see pages 9-10, filed 11/21/2025 have been fully considered but they are not persuasive.
In response to applicant’s argument that the references fails to disclose: “the optical fiber pump combiner arranges and combines various optical fibers integrally according to a preset method, and the 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” (Remarks, page 9), the examiner disagrees. The examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
In this case, as discussed above in the rejection of claim 1 under 35 U.S.C. 103, Yu fails to teach: “the optical fiber pump combiner arranges and combines various optical fibers integrally according to a preset method, and the 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” as discussed in the applicant’s argument. Sun provides teachings of a multi-spectrum LED light source system for generating multiple different wavelengths to direct towards a sample (Fig. 1; paragraph [0024; abstract); an optical fiber pump combiner (Fig. 1 and paragraph [0024], element 5, which combines optical fibers 4); and 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). Kajihara provides 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 (paragraph [0011]).
It would have been obvious to one of ordinary skill in the art 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 board, 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 the 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: “the 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” as argued by the applicant (Remarks, page 9). 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 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: the 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.
Therefore, there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art to have arrived at the argued claim limitations of: “the optical fiber pump combiner arranges and combines various optical fibers integrally according to a preset method, and the 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”.
Additionally, applicant’s argument that the reference documents do not disclose “the optical fiber pump combiner arranges and combines various optical fibers integrally according to a preset method, and the 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” (Remarks, pages 9-10) is a mere conclusory statement and fails to specifically point out how the language of the claims patentably distinguishes them from the references, or why it would not be obvious to combine the references.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “without using a filter”, Remarks, page 9; “detect different multi-channel spectrum…detecting a plurality of fluorescence marks at the same time…detecting various different nucleic acids at the same time”, Remarks, page 9; the “detection method…for solving the Ct value”, Remarks, page 10) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758