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 .
DETAILED ACTION
Election/Restrictions
1. Applicant’s election of Group 1, Claims 1-9 in the reply filed on 07/29/26 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)). Therefore, claim 10 have been withdrawn acknowledged.
Priority
2. Applicant is reminded that in order for a patent issuing on the instant application to obtain the benefit of priority based on priority papers filed in parent Application No. (CN) 2022115884141 under 35 U.S.C. 119(a)-(d) or (f), a claim for such foreign priority must be timely made in this application. To satisfy the requirement of 37 CFR 1.55(a)(2) for a certified copy of the foreign application, applicant may simply identify the application containing the certified copy.
Drawings
3. The drawings filed on 12/04/23 are objected because some elements in the specification are not described clearly in drawings. For example, detection control mechanism, quartz cuvette, and connection body, are not described in the drawings.
Figure 1 disclosed aptamer fluorescence sensor 3, excitation light source 103, signal acquisition and photoelectric conversion module 104, signal chain processing module 105, microcontroller 102, Bluetooth module 106, detection control mechanism. However, it is not clear how can these elements connect and work with fluorescence rapid detection mechanism 2 in figures 2-4? Where are these elements being disclosed in figures 2-4? In the other words, the drawings must disclose the relationships/positions of the elements in figure 1 with the device in figures 2-4.
Further, what is the relationship of excitation light source 103 in figure 1, with fixing holes 210, 209, thread fixing hole 215, and emitted-light receiving hole 217, in figures 2-4, in order to emit/receive excitation light to irradiate the solution to be detected in the quartz cuvette?
Appropriate correction is required.
Claim/Specification Objections
4. Claim 9 and specification are objected to because of the following informalities: the equation of the base sequence of the used oligonucleotides aptamer is not disclosed appropriately. Specification paragraph [0070] has the same problem. Therefore, claim 9 is not searchable. Appropriate correction is required.
Claim Rejections - 35 USC § 112
5. 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.
6. Claims 1-9 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 pre-AIA the applicant regards as the invention.
Figure 1 disclosed aptamer fluorescence sensor 3, excitation light source 103, signal acquisition and photoelectric conversion module 104, signal chain processing module 105, microcontroller 102, Bluetooth module 106, detection control mechanism. However, it is not clear how can these elements connect and work with fluorescence rapid detection mechanism 2 in figures 2-4? Where are these elements being disclosed in figures 2-4? In the other words, the drawings must disclose the relationships/positions of these elements in figure 1 with the device in figures 2-4.
Further, what is the relationship of excitation light source 103 in figure 1 with fixing holes 210, 209, thread fixing hole 215, and emitted-light receiving hole 217, in figures 2-4, in order to emit/receive excitation light to irradiate the solution to be detected in the quartz cuvette?
Moreover, there is no definition/structure in the specification for the following elements: detection control mechanism, signal acquisition and photoelectric conversion module 104, signal chain processing module 105, microcontroller 102. Are these elements chips? Or circuits? Or instruction programs? These wordings render the claims indefinite because the wordings are not defined by the claims, and the specification does not provide a standard definition/explanation/structure for ascertaining the requisite degree that one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In the other words, the claims do not meet the threshold requirements of clarity and precision set forth in the statute, not whether more suitable language or modes of expression are available. The claims are required to be cast in clear—as opposed to ambiguous, vague, indefinite—terms.
Claim Rejections - 35 USC § 103
7. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
8. 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 of this title, 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.
9. Claim(s) 1, 2, 7, 8, is/are rejected under 35 U.S.C. 103 as being unpatentable over Choe et al. (KR 20200085499) in view of Mckee et al. (U.S. Pat. No. 20140312247), further in view of Tai et al. (U.S. Pub. No. 2015/0309011). Hereafter “Choe”, “Mckee”, “Tai”. (Please see attached files for Choe’s reference).
Regarding Claim(s) 1, Choe a BNP aptamer fluorescence detection device (page 2, lines 8), comprising a detection control mechanism, a fluorescence rapid detection mechanism and an aptamer fluorescence sensor (figure 1, microcontroller 70 is not different from a detection control mechanism. Figure 2 is not different from a fluorescence rapid detection mechanism. Figure 1, photodiode 50 is not different from aptamer fluorescence sensor. Please see the Objection/Rejection in paragraphs 3-5 above); wherein the detection control mechanism includes a power supply module, a microcontroller, an excitation light source, a signal acquisition and photoelectric conversion module, a signal chain processing module, (figures 1, 2, a power supply module 90; a microcontroller 70; microcontroller 70 is not different from a signal chain processing module. Please see the Objection/Rejection in paragraphs 3-5 above), which outputs a power supply voltage to the power supply module, and supplies power to the detection control mechanism (figure 1, power supply module 90, microcontroller 70 is not different from a detection control mechanism. Please see the Objection/Rejection in paragraphs 3-5 above); the microcontroller is connected with the excitation light source, the signal acquisition and photoelectric conversion module and the signal chain processing module by way of signals (figures 1, 2, light source 10, the microcontroller 70 is not different from the signal acquisition and photoelectric conversion module and the signal chain processing module); the excitation light source is configured to turn on and off according to the control signal of the microcontroller, and generate excitation light with a set wavelength (page 4, lines 21-23. It is inherent that excitation light must have a set wavelength); the signal acquisition and photoelectric conversion module is configured to capture a fluorescence signal generated form the solution to be detected according to the control signal of the microcontroller, and convert the fluorescence signal into an electrical signal, which is transmitted to the microcontroller (Abstract; Page 4, lines 19-23); the signal chain processing module is configured to receive electrical signals transmitted by the microcontroller, and transmit processed results to the microcontroller (figure 1, it is inherent that the microcontroller 70 receive, transmit and process electrical signals);
the fluorescence rapid detection mechanism is configured to place the aptamer fluorescence sensor to detect BNP under the control of the detection control mechanism (figure 1, element 70 is not different from fluorescence rapid detection mechanism, photodetector 50 is not different from fluorescence sensor); the fluorescence rapid detection mechanism includes a main box, detection operation and result display (figure 1, element 70 is not different from fluorescence rapid detection mechanism; Figure 2, house 20 is not different from a main box); the inside of the main box is provided with an inner shell, which is distanced from the main box to a certain extent (figure 2, house portion is not different from the main box, seating portion 24 is not different from an inner shell); the signal acquisition and photoelectric conversion module and a main control circuit board are fixed and installed on the inner shell, which is provided with a fixing hole of excitation light sources (figures 1, 2, element 70 is not different from the signal acquisition and photoelectric conversion module, element 60 is not different from a main control circuit board, seating portion 24 is not different from an inner shell, a fixing hole 25 of excitation light sources 10); the main control board integrates the power supply module, the microcontroller, the signal chain processing module (figures 1, 2, circuit board is not different from the main control board, power supply unit 90 is not different from the power supply module, element 70 is not different from the signal chain processing module); a fluorescent signal reaction table is arranged inside the inner shell, the portion of the fluorescence signal reaction table far away from the fixing hole of excitation light sources is provided with a fluorescence signal reaction cell, which is used to place a quartz cuvette containing the solution to be detected (the following figures 1, 2, sample holder portion 21 is not different from a fluorescent signal reaction table, seating portion 24 is not different from an inner shell, light source insert part is not different from the fixing hole of excitation light sources 10, receiving space is not different from a quartz cuvette, element CC is not different from fluorescence signal reaction cell); the portion of the fluorescence signal reaction table close to the fixing hole of excitation light sources is provided with a thread fixing hole for excitation light, which communicates with the fluorescence signal reaction cell, and is coaxial with the fixing hole of excitation light sources, so that the fixing hole of excitation light sources and the thread fixing hole for excitation light jointly fix a LED excitation light source (figures 1, 2, sample holder portion 21 is not different from a fluorescent signal reaction table, light source insert part is not different from the thread fixing hole, light sources 10); the connection of the thread fixing hole for excitation light and the fluorescence signal reaction cell is provided with an excitation filter groove, which is used to accommodate an excitation filter (figures 1, 2, light source insert part is not different from the thread fixing hole, excitation filter groove accommodated with excitation filters 30, 40); a connection body is set between the fluorescence signal reaction table and the inner shell, and an emitted-light receiving hole is opened inside the connection body (the following figure 2, sample holder portion 21 is not different from a fluorescent signal reaction table, seating portion is not different from the inner shell, light source insert part is not different from emitted-light receiving hole, the connection body AA); the emitted- light receiving hole communicates with the fluorescence signal reaction cell, and the emitted-light receiving hole and the thread fixing hole for excitation light are vertical with each other in the horizontal direction at the fluorescence signal reaction cell (the following figures 1, 2, the emitted- light receiving hole BB, element CC is not different from fluorescence signal reaction cell, light source insert part is not different from the emitted-light receiving hole and the thread fixing hole); the connection between the emitted-light receiving hole and the fluorescence signal reaction cell is provided with an emission filter slot, which is used to accommodate a emission filter (the following figures 1, 2, the emitted-light receiving hole BB, element CC is not different from fluorescence signal reaction cell, emission filter slot DD); thus, the excitation light with a preset wavelength generated from the excitation light source irradiates the fluorescence signal reaction cell via the excitation filter, and the solution to be detected in the quartz cuvette inside the fluorescence signal reaction cell generates a fluorescent signal, which is transmitted to the signal acquisition and photoelectric conversion module through the emitted-light receiving hole after passing through the emission filter (the following figures 1. 2, fluorescence signal reaction cell CC; element 70 is not different from the signal acquisition and photoelectric conversion module; the excitation filter 30, 40; the emitted-light receiving hole BB. It is inherent that the excitation light is a preset wavelength);
However, Choe does not teach smart phone, Bluetooth, the input end of the power supply module is configured to connect with the USB interface of a smart phone, perform analog-to-digital conversion and filter amplification on the electrical signal, the Bluetooth module is configured to transmit a command signal of a smart phone to the microcontroller, and transmit processed results obtained by the microcontroller to a smart phone to display, and a smart phone support, the smart phone support is configured to place a smart phone to carry out power supply.
Mckee teaches smart phone (abstract), Bluetooth ([0020], lines 1-4), the input end of the power supply module is configured to connect with the USB interface of a smart phone ([0035]), the Bluetooth module is configured to transmit a command signal of a smart phone to the microcontroller, and transmit processed results obtained by the microcontroller to a smart phone to display (figures 1, 3, smartphone 101, display screen 350. It is inherent that smartphone must has Bluetooth module and microcontroller), and a smart phone support, the smart phone support is configured to place a smart phone to carry out power supply (figure 3, smartphone 301, surface of assembly 375 is not different from the smart phone support).
Further, Choe as modified by Mckee, teaches all limitations as stated above except for perform analog-to-digital conversion and filter amplification on the electrical signal. Tai discloses perform analog-to-digital conversion and filter amplification on the electrical signal ([060], lines 10-11).
Choe as modified by Mckee and Tai does not teach the aptamer fluorescence sensor being prepared by using oligonucleotides marked by carboxy fluorescein as an aptamer and carboxylated graphene oxide as a fluorescence quencher for the BNP detection, so as to obtain the signal response relation between the BNP concentration and fluorescence intensity according to the analysis of multi-groups of experimental data. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify method or device of Choe as modified by Mckee and Tai with oligonucleotides marked by carboxy fluorescein as an aptamer and carboxylated graphene oxide as a fluorescence quencher, 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 intended use as a matter of obvious design choice. in re Leshin, 125 USPQ 416.
Regarding Claim(s) 2, Choe as modified by Mckee and Tai, teach the aptamer fluorescence detection device according to claim 1 as stated above except for the output end of the power supply module is configured to connect with the microcontroller, the excitation light source and the signal acquisition and photoelectric conversion module, to output a 3.3V supply voltage to the microcontroller, output a 5V supply voltage to the excitation light source and output a ±5V supply voltage to the signal acquisition and photoelectric conversion module, respectively, and the signal chain processing module and the Bluetooth module are powered under a 3.3V voltage output by the microcontroller. The selection of 3.3V supply voltage or ±5V supply voltage or similar range is well known. It would have been obvious to one having ordinary skill in the art at the time of the invention was made to choose appropriate heating range for the LCD for the benefit of well operated cell gap LCD inspection system. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
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Regarding Claim(s) 7, 8, Choe as modified by Mckee and Tai, teach the aptamer fluorescence detection device according to claim 1 as stated above except for the emitted-light receiving hole is set as a conical hole, the diameter of which gradually shrinks from the fluorescence signal reaction cell to the inner shell, achieving the aggregation of light, and the smart phone support has a slope, a semicircular arc-shaped baffle with an opening is set at the bottom of the slope, and the opening is in correspondence with the position of the USB interface of a smart phone. The difference between the claimed invention and the Choe, Mckee and Tai devices is the shape of the emitted-light receiving hole, a semicircular arc-shaped baffle with an opening is set at the bottom of the slope. Although the Choe, Mckee and Tai devices do not teach the exact shape of the emitted-light receiving hole, a semicircular arc-shaped baffle with an opening is set at the bottom of the slope, as that claimed by Applicant, the shape differences are considered obvious and are not patentable unless unobvious or unexpected results are obtained from these changes. Additionally, the Applicant has presented no discussion in the specification which convinces the Examiner that the particular shape of the hole and baffle is anything more than one of numerous shapes a person of ordinary skill in the art would find obvious for the purpose of providing support. In re Dailey, 149 USPQ 47 (CCPA 1976). It appears that these changes produce no functional differences and therefore would have been obvious.
10. Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Choe et al. (KR 20200085499) in view of Mckee et al. (U.S. Pat. No. 20140312247), further in view of Tai et al. (U.S. Pub. No. 2015/0309011), further in view of Omaa et al. (JP 2515428). Hereafter “Choe”, “Mckee”, “Tai”, “Omaa”. (Please see attached files for Choe’s and Omaa’s references).
Regarding Claim(s) 3, Choe as modified by Mckee and Tai, teach the aptamer fluorescence detection device according to claim 1 as stated above except for black ABS resin by integrated molding. Omaa teaches black ABS resin by integrated molding (page 13, lines 7-11). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention was made to modify Choe as modified by Mckee and Tai by having Choe as modified by Mckee and Tai in order to have a good absorbent layer (Omaa, page 13, lines 7-11).
11. Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Choe et al. (KR 20200085499) in view of Mckee et al. (U.S. Pat. No. 20140312247), further in view of Tai et al. (U.S. Pub. No. 2015/0309011), further in view of Matoba (U.S. Pub. No. 2019/0250104). Hereafter “Choe”, “Mckee”, “Tai”, “Matoba”. (Please see attached files for Choe’s references).
Regarding Claim(s) 5, Choe as modified by Mckee and Tai, teach the aptamer fluorescence detection device according to claim 1 as stated above except for a signal lamp placing hole used to determine whether the main control circuit board functions to power a signal lamp; a wiring port is arranged below the back of the main box, used for the lines led from the inside of the main box. Mckee further teaches a wiring port is arranged below the back of the main box, used for the lines led from the inside of the main box (figure 3, cable 355 arranged below the back of the main box 375). Matoba teaches a signal lamp placing hole ([0108], lines 7-11. Note: the limitation “used to determine whether the main control circuit board functions to power a signal lamp” is just an intended used functional limitation). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention was made to modify Choe as modified by Mckee and Tai by having signal lamp placing hole in order to operate the system efficiently.
12. Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Choe et al. (KR 20200085499) in view of Mckee et al. (U.S. Pat. No. 20140312247), further in view of Tai et al. (U.S. Pub. No. 2015/0309011), further in view of Williamson et al. (U.S. Pat. No. 12,502,669). Hereafter “Choe”, “Mckee”, “Tai”, “Williamson”. (Please see attached files for Choe’s references).
Regarding Claim(s) 6, Choe as modified by Mckee and Tai, teach the aptamer fluorescence detection device according to claim 1 as stated above except for the front plate, rear plate and side plate define the inner shell, the signal acquisition and photoelectric conversion module is fixed on the surface of the front plate by screws, the main control circuit board is embedded on the surface of the back plate, and the fixing hole of excitation light sources is opened in the middle position of the side plate. Choe further teaches the front plate, rear plate and side plate define the inner shell (figure 2, element 24 is not different from inner shelf containing the front plate, rear plate and side plate), the main control circuit board is embedded on the surface of the back plate (figure 2, element 60 is not different from main control circuit board), and the fixing hole of excitation light sources is opened in the middle position of the side plate (figure 2, element 25 is not different from fixing hole). Williamson teaches the module is fixed on the surface of the front plate by screws (column 48, lines 58-64). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention was made to modify Choe as modified by Mckee and Tai by having signal lamp placing hole in order to facilitate removably coupling the module frame, (Williamson, column 48, lines 58-64).
Allowable Subject Matter
13. The following is a statement of reasons for the indication of allowable subject matter: there was no prior art found by the examiner that suggested modification or combination with the cited art so as to satisfy the combination of all the limitations in claim 4, and if rewritten or amended to overcome the Objection and the rejection(s) under 35 U.S.C. 112, set forth in this Office action.
14. As claim 4, the prior art of record taken alone or in combination, fails to disclose or render obvious a BNP aptamer fluorescence detection device based on a smart phone, comprising a detection control mechanism, a fluorescence rapid detection mechanism and an aptamer fluorescence sensor; the detection control mechanism, a signal acquisition and photoelectric conversion module, a signal chain processing module and a Bluetooth module; the fluorescence rapid detection mechanism includes a main box and a smart phone support, the smart phone support, an inner shell, a fixing hole of excitation light sources; the fluorescence signal reaction table, a fluorescence signal reaction cell, which is used to place a quartz cuvette containing the solution to be detected; the connection of the thread fixing hole for excitation light and the fluorescence signal reaction cell is provided with an excitation filter groove, which is used to accommodate an excitation filter; the emitted- light receiving hole communicates with the fluorescence signal reaction cell, and the emitted-light receiving hole and the thread fixing hole for excitation light are vertical with each other in the horizontal direction at the fluorescence signal reaction cell; the connection between the emitted-light receiving hole and the fluorescence signal reaction cell is provided with an emission filter slot; the aptamer fluorescence sensor is prepared by using oligonucleotides marked by carboxy fluorescein as an aptamer and carboxylated graphene oxide as a fluorescence quencher for the BNP detection, so as to obtain the signal response relation between the BNP concentration and fluorescence intensity according to the analysis of multi-groups of experimental data; wherein the top surface of the main box is provided with an opening, at which a light-tight flap is arranged; the rear side of the light-tight flap is hinged with the main box, so as to facilitate the replacement of the solution to be detected during a detection operation; the front, back, and side of the main box are provided with openings, at which a light-tight baffle is installed; the light-tight baffle is inserted and removed by means of a baffle slide set on the main box; in combination with the rest of the limitations of claims 1 and 4.
Fax/Telephone Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRI T TON whose telephone number is (571)272-9064. The examiner can normally be reached on 8am-4pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michelle Iacoletti can be reached on (571)270-5789. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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August 22 2026
/Tri T Ton/
Primary Examiner Art Unit 2877
Prosecution Insights