DETAILED ACTION
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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/01/2022 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election with traverse of Group I, claims 1-9 in the reply filed on 09/09/2025 is acknowledged. The traversal is on the ground(s) that the Office has not demonstrated that the claims are obviated by any combination of the asserted references. This is not found persuasive because the present restriction is filed under 35 U.S.C. § 371 and no showing of obviousness is required. Further, it is noted that 35 U.S.C. § 103 was not applied in the restriction requirement dated 04/10/2025. Claims 10-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 09/09/2025.
The requirement is still deemed proper and is therefore made FINAL.
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 7-9 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.
Claim 7 recites the limitations “the optical shutter” in line 15 and “the multi-path white light/fluorescence switching control system” in lines 16 and 17. There is insufficient antecedent basis for these limitations in the claim.
Claims 8 and 9 depend on claim 7 and are therefore, rejected for the same reason.
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.
Claim(s) 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al. (hereinafter Huang) CN 106085842 A in view of Huang et al. (hereinafter Huang) CN 108913599 A cited in the IDS filed 04/01/2022.
Regarding claim 1, Huang ‘842 discloses a nucleic acid amplification in-situ real-time detection system using a microfluidic chip through optical fiber sensing, wherein, the system comprises: one or more white light sources (In a preferred embodiment, as shown in FIG. 5 (b), the optical detecting system comprises an excitation light source LED), one or more first optical fiber sensors (In1 to In20), one or more detection optical paths (CCD area array detector), one or more microfluidic chips (microfluidic chips MC), a multi-path PID temperature control system (temperature control system MPIDS), a CAN-bus multi-axis motion control system (multi-axis motion control system MMDS), one or more second optical fiber sensors (In1 to In20), and a spectrum acquisition, processing and display module (data collection processing and display system DSCXS/MSCXS) as discussed in at least Examples 1 and 2; and shown in Figs. 1, 7 and 8; wherein each of the white light sources is configured to generate white light; the first optical fiber sensors connect a white light source and a detection optical path; the detection optical path is configured to transmit the white light generated by the white light source to a microfluidic chip and then transmit an optical signal made by the microfluidic chip to the spectrum acquisition, processing and display module (each optical fiber unit adopts 1 inlet 2 outlet of the fiber bundle arrangement, 1-path inlet end of the optical fiber unit (In) to microfluidic chip MC, in 2 path outlet end of the optical fiber unit path (such as Out1-1 to Out1-20) by means of an excitation filter (e.g. F1-1 to F1-20) is connected with the excitation light source (such as LED1 to LED20). the other path (e.g., Out2-1 to Out2-20) are arranged in area array (e.g. Out2-1 to Out2-20) is directly coupled through the emission filter or through a lens imaging onto a photosensitive sensor of CCD area array detector); the microfluidic chip is configured to carry out biochemical reaction (the nucleic acid sample to be analyzed is dissolved reagent for nucleic acid detection), and a sample to be detected in the microfluidic chip is subjected to no fluorescence-labeling; the microfluidic chip is further connected to a temperature controller as shown in Figs. 1 and 6, the multi-path PID temperature control system is configured to regulate a temperature of the microfluidic chip, and the multi-path PID temperature control system is connected to the CAN-bus multi-axis motion control system; the second optical fiber sensors are configured to transmit the optical signal of the microfluidic chip to the spectrum acquisition, processing and display module as discussed in at least Examples 1 and 2; and the spectrum acquisition, processing and display module includes an optical fiber scanner for receiving the optical signal transmitted by the second optical fiber sensors(the optical fiber bundle is fixed on the 1 one-dimensional motion control scanner, by one-dimensional translational or rotational motion control scanner a plurality of fiber beam of the other end (such as Out1 to Out20) sequentially through the detection window of the photoelectric detector); the spectrum acquisition, processing and display module analyzes the optical signal and generates visualized biochemical reaction real-time dynamic change signal curves (the micro-fluidic chip in the MC to a nucleic acid sample under the excitation light source LED is excited to generate fluorescence by double focal plane imaging lens group reaches the optical diffraction limit the fluorescence collecting efficiency; fluorescence is condensed on the photoelectric detector PMT into an analogue signal, the photoelectric detector PMT transmits the generated analog signal to the data collection, processing and display system DSCXS generates a real-time fluorescent detection signal, and displaying in real time fluorescence detection signal curve) discussed in at least Examples 1 and 2. Also see whole document.
Huang ‘842 does not explicitly disclose that the LED light source is a white light source.
Huang ‘599 discloses the use of white light sources as discussed in at least the abstract and claims 2 and 4. Also see whole document.
Therefore, absent unexpected results, it would have been prima facie obvious to one of ordinary skill to modify the LED light source of Huang ‘842 with the white light sources as taught by Huang ‘599, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. See MPEP §2144.07.
Regarding claim 2, the optical detection system (ODS) of Huang‘842 as modified is capable of performing white light interfered hyperspectral non-label real-time detection for a trace sample placed within a reaction unit of the microfluidic chip, and sends a detection result to the spectrum acquisition, processing and display module in real time discussed in at least Examples 1 and 2. Also see whole document.
The optical fiber scanner (1 one-dimensional motion control scanner) of Huang‘842 as modified is capable of controlling a plurality of the optical fiber sensors in a rotational or translational scanning manner so that white light interfered hyperspectral signals received from a plurality of the detection optical paths are transmitted to the spectrum acquisition, processing and display module one by one, so as to enable high-throughput parallel nucleic acid amplification non-label in-suit real-time detections by a plurality of the microfluidic chips through optical fiber sensing discussed in at least Examples 1 and 2; and shown in Fig. 1. Also see whole document.
Regarding claim 3, Huang ‘842 discloses wherein, the microfluidic chip is arranged inside a thermostatic airtight cavity (drawer) which is provided inside with a heater (heating film and insulating cover), a temperature sensor, and a temperature controller (MPIDS), wherein the heater is arranged at upper and lower surfaces of the microfluidic chip and heats the microfluidic chip though a flowing heating method using a sub-millimeter thin-layer air bath (The invention adopts reaction system of micro-fluidic chip can realize single target nucleic acid detection within 1.5 Mu L, detection limit reaches 10 nucleic acid molecule copies and uses thin air bath flow heating mode for heating the microfluidic chip); the temperature controller is configured to control the temperature of the microfluidic chip; opening/closing of the thermostatic airtight cavity is controlled by the CAN-bus multi-axis motion control system to facilitate loading/unloading of the microfluidic chip (insulating disc is covered with insulating cover form a constant seal cavity, insulation disc and the insulating cover are respectively provided with a heating film and a temperature sensor, a heating film is respectively connected with multiple PID temperature control system and temperature sensor. the photoelectric switch is set in rotational motion locating shaft, a driving motor for controlling the rotation initial position, the drawer is further fixed optical detection system) discussed in at least Example 2; and shown in Fig. 6. Also see whole document.
Regarding claim 4, Huang‘842 discloses wherein, a center of the microfluidic chip is in shaft connection with a first motor, and the CAN-bus multi-axis motion control system controls rotation of the first motor to drive the microfluidic chip to rotate, so that uniformity of temperature in the thermostatic airtight cavity is ensured, driving of a fluid switching control unit on the microfluidic chip is implemented, and a need for step-by-step control of sample preparation, nucleic acid or protein sample separation and purification, and nucleic acid amplification is met (nucleic acid amplification detection sub module chip comprises an insulating disc, an insulating cover, a microfluidic chip, a rotational motion, a locating shaft, a driving motor, a photoelectric switch, an optical detection system, more than one heating film and more than one temperature sensor, an insulating cover top center is provided with a through hole. the base of driving motor is fixedly provided with a fixed rotation motion locating shaft is connected to the output shaft of the driving motor, the rotation movement position shaft passes through from the center hole of the insulating disc, micro-fluidic chip is fixed in the rotation movement position shaft end, insulating disc is covered with insulating cover form a constant seal cavity, insulation disc and the insulating cover are respectively provided with a heating film and a temperature sensor, a heating film is respectively connected with multiple PID temperature control system and temperature sensor. the photoelectric switch is set in rotational motion locating shaft, a driving motor for controlling the rotation initial position…an optical detection system of the present embodiment with the structure of the optical detection system of the embodiment 1 have the same structure, here the multi-axis motion control system for controlling each driving motor drives the rotation locating shaft motion, multi-channel PID temperature control system for temperature of the microfluidic chip to adjust and control.) discussed in at least Examples 1 and 2; and shown in Fig. 4. Also see whole document.
Allowable Subject Matter
Claims 5 and 6 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Prior art of record does not disclose in the claimed environment a nucleic acid amplification in-situ real time detection system of claim 1 further limited by the features in claim 5.
Conclusion
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/LYDIA EDWARDS/Primary Examiner, Art Unit 1796