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 .
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-16 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Pang et al. (US20190204262A1).
The applied reference has a common assignee and inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding Claim 1, Pang et al. teaches a digital microfluidic nucleic acid detection chip (See the Abstract, the electrochemical detection chip, and the Claim(s) 1-17 in [0004]-[0020], [0031]-[0088] in Fig. 1-9) comprising: a first substrate (See the combination of layers attached to the first substrate 10 in [0035] in Fig. 1); and
a second substrate (See the second substrate 20 in [0035] in Fig. 1), assembled with the first substrate, wherein a cavity formed between the first substrate and the second substrate comprises a functional region (See in [0035]-[0086] in Fig. 1-9),
the functional region is configured to perform a nucleic acid detection processing on a droplet to be detected and obtain a hybridization color development signal for indicating whether a target gene exist in the droplet to be detected (See the detection electrodes 21,22 and see how at least one small droplet is separated from the liquid, and the at least one small droplet is driven to move to at least one driving electrode 11 at at least one detection position in [0038] in Fig. 1-9);
the first substrate at least comprises a plurality of drive units arranged in an array, the plurality of drive units are configured to drive the droplet to be detected to move (See how the multiple driving electrodes 11 can drive a droplet of the liquid to be tested and a droplet of the analytical reagent to move to a same driving electrode 11 along a same or two different paths, so as to mix the droplet of the analytical reagent and the droplet of the liquid to be tested, and make the droplet of the liquid to be tested in contact with the first detection electrode 21 and the second detection electrode 22 on the second substrate 20 that are directly opposite the driving electrode 11 before and after they are mixed with the droplet of the analytical reagent in [0038], [0057], [0084] in Fig. 1-9), a volume of the droplet to be detected is 10 µl to 200 µl, and a dimension of a drive unit is 2 mm to 100 mm in a moving direction of the droplet to be detected (See in [0034]-[0041], [0050], [0067] [0084]).
Regarding Claim 2, Pang et al. teaches the detection chip limitations of claim 1.
Pang et al. further teaches a digital microfluidic nucleic acid detection chip (See the Abstract, the electrochemical detection chip, and the Claim(s) 1-17 in [0004]-[0020], [0031]-[0088] in Fig. 1-9), wherein on a plane parallel to the digital microfluidic nucleic acid detection chip, the first substrate at least comprises: an electrode region, a bonding region located on a side of the electrode region in a first direction, and a lead region located on a side of the electrode region in a second direction, wherein the first direction intersects with the second direction (See the plurality of independent driving electrodes 11, the first detection electrodes 21 and the second detection electrodes 22 in [0035]-[0044] in Fig. 1-9; Also, see the plurality of first bonding electrodes 15 disposed on the first substrate and configured to bond a circuit board 100, and the plurality of second bonding electrodes 19 in [0061]-[0075] in Fig. 3);
the plurality of drive units are disposed in the electrode region (See the plurality of independent driving electrodes 11 in [0038], [0057], [0084] in Fig. 1-9), each of the drive units comprises a plurality of control electrodes arranged in an array, the bonding region comprises a plurality of bonding pins, the lead region comprises a plurality of signal leads, and each bonding pin is respectively connected with control electrodes at a same position in the plurality of drive units through the signal leads (See the plurality of wires in the first signal wiring layer 13 are electrically connected with the plurality of driving electrodes 11 through via holes formed in the first dielectric layer 14 to transmit signals to the driving electrodes in [0053], [0074 in Fig. 1-3).
Regarding Claim(s) 3-6, Pang et al. teaches the detection chip limitations of claim 2.
Pang et al. further teaches a digital microfluidic nucleic acid detection chip (See the Abstract, the electrochemical detection chip, and the Claim(s) 1-17 in [0004]-[0020], [0031]-[0088] in Fig. 1-9), wherein the drive unit comprises a plurality of control electrodes forming m electrode rows and an electrode columns, and control electrodes of an i-th row and a j-th column in the plurality of drive units are respectively connected with a same bonding pin through the signal leads, wherein 1≤i≤m, 1≤j≤n, and m and n are positive integers (See in [0035]-[0086] in Fig. 1-9 and in Claim(s) 1-20);
wherein m is 5 to 50 and n is 5 to 50 (See in [0035]-[0086] in Fig. 1-9);
wherein a quantity of the signal leads is the same as a quantity of control electrodes in the drive unit (See in [0035]-[0086] in Fig. 1-9);
wherein the electrode region further comprises a plurality of connection lines (See the at least one connection electrode 12a disposed on the base substrate 10 in [0017],[0059] in Fig. 3; Also, see the electric connection structures 60 disposed in a connection region 30 in [0076] in Fig. 7-9) a first end of at least one connection line is respectively connected with the control electrodes at the same position in the plurality of drive units, and a second end of the connection line is connected with a first end of a signal lead after extending to the lead region, and a second end of the signal lead is connected with the bonding pin after extending to the bonding region (See in [0035]-[0086] in Fig. 1-9).
Regarding Claim(s) 7-9, Pang et al. teaches the detection chip limitations of claim 6.
Pang et al. further teaches a digital microfluidic nucleic acid detection chip (See the Abstract, the electrochemical detection chip, and the Claim(s) 1-17 in [0004]-[0020], [0031]-[0088] in Fig. 1-9), wherein the electrode region further comprises a plurality of via groups arranged in an array, each via group comprises a plurality of vias arranged in an array, and a first end of at least one connection line is connected with the control electrodes at the same position in the plurality of drive units, respectively, through vias at a same position in the plurality of via groups (See the electric connection structures 60 disposed in a connection region 30 in [0076]-[0084] in Fig. 7-9);
wherein the via group comprises a plurality of vias forming m via rows and n via columns, and a first end of at least one connection line is respectively connected with control electrodes of an i-th row and a j-th column in the plurality of drive units through vias of the i-th row and the j-th column in the plurality of via groups, 1≤i≤m, 1≤j≤n, and m and n are all positive integers (See in [0035]-[0086] in Fig. 1-9 and in Claim(s) 1-20);
wherein a control electrode comprises a first side and a second side oppositely disposed in the first direction, and a third side and a fourth side oppositely disposed in the second direction; in the first direction, distances between a plurality of vias in each via row and first sides of corresponding control electrode are disposed to be gradually increased or gradually decreased; in the second direction, distances between a plurality of vias in each via column and third sides of corresponding control electrode are equal; and distances between vias at a same position in each via group and first sides of corresponding control electrode are equal (See in [0035]-[0086] in Fig. 1-9 and in Claim(s) 1-20).
Note that what is discussed in MPEP § 2144 VI. concerning the rearrangement of parts of a claimed invention in comparison to the prior art. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice). The instant application recites the limitations of a "plurality of drive units", "plurality of via groups", and "control electrodes" in relation to columns and rows on a chip. However, the configuration of these technical components would not change the function of the detection chip and would be anticipated in view of the prior art.
Regarding Claim(s) 10-14, Pang et al. teaches the detection chip limitations of claim 6.
Pang et al. further teaches a digital microfluidic nucleic acid detection chip (See the Abstract, the electrochemical detection chip, and the Claim(s) 1-17 in [0004]-[0020], [0031]-[0088] in Fig. 1-9), wherein on a plane perpendicular to the digital microfluidic nucleic acid detection chip, the first substrate (See the combination of layers attached to the first substrate 10 in [0035] in Fig. 1) comprises: a first base substrate (See the first substrate 10 in [0035] in Fig. 1), a first conductive layer disposed on a side of the first base substrate facing the second substrate (See the first dielectric layer 14 in [0053] in Fig. 1), a first insulation layer disposed on a side of the first conductive layer facing the second substrate, a second conductive layer disposed on a side of the first insulation layer facing the second substrate (See the second dielectric layer 17 in [0064] in Fig. 1), and a first lyophobic layer disposed on a side of the second conductive layer facing the second substrate (See the first hydrophobic layer 16 in [0062] in Fig. 1); and the control electrodes are disposed in the second conductive layer, the connection lines are disposed in the first conductive layer, a via is disposed on the first insulation layer, and a control electrode is connected with a connection line through the via (See in [0035]-[0086] in Fig. 1-9 and in Claim(s) 1-20);
wherein the signal leads are disposed in the first conductive layer or the second conductive layer (See how the first signal wiring layer 13 includes the plurality of wires arranged on the first substrate 10 in a certain wiring manner. The wires are configured to contact the plurality of driving electrodes 11 through via holes formed in the first dielectric layer 14, thereby transmitting signals to the driving electrodes 11 and achieving directional movement of the above droplets in two-dimensional directions in the space between the first substrate 10 and the second substrate 20 in [0055] in Fig. 1-9;
wherein the second substrate comprises a second base substrate, a second structural layer disposed on a side of the second base substrate facing the first substrate, and a second lyophobic layer disposed on a side of the second structural layer facing the first substrate (See the second hydrophobic layer 23 disposed on a side of the second substrate 20 facing toward the first substrate in [0065];
wherein a distance between a surface on a side of the first lyophobic layer close to the second substrate and a surface on a side of the second lyophobic layer close to the first substrate is 2 µm to 2000 µm (See in [0034]-[0041], [0050], [0067] [0084]);
wherein an initial contact angle between the droplet to be detected with at least one of the first lyophobic layer and the second lyophobic layer is 105° to 120° (See in [0062]-[0065] in Fig. 1-9).
Regarding Claim(s) 15-16, Pang et al. teaches the detection chip limitations of claim 1.
Pang et al. further teaches a digital microfluidic nucleic acid detection chip (See the Abstract, the electrochemical detection chip, and the Claim(s) 1-17 in [0004]-[0020], [0031]-[0088] in Fig. 1-9), wherein the drive unit comprises a full-face control electrode or a plurality of control electrodes arranged in an array, and an area of the full-face control electrode is equal to a sum of areas of the plurality of control electrodes arranged in the array (See the plurality of independent driving electrodes 11 in [0038], [0057], [0084] in Fig. 1-9);
wherein the drive unit comprises a plurality of control electrodes and a dimension of a control electrode 1.5 mm to 2 mm in a moving direction of the droplet to be detected (See how the liquid storage electrode 12 is in a range of 1 mm to 10 mm, and see how the size of the second driving electrode 112 is 0.01-1mm in [0050], [0067]).
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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) 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Pang et al. (US20190204262A1) as applied to claim(s) 1 and 6 above, and further in view of Corey et al. (US20210060566A1).
Regarding Claim 17, Pang et al. teaches the detection chip limitations of claim 1.
Pang et al. fails to explicitly teach a digital microfluidic nucleic acid detection chip, wherein the functional region at least comprises: a nucleic acid extraction region, a nucleic acid amplification region, a nucleic acid detection region, a first communication path for communicating the nucleic acid extraction region and the nucleic acid amplification region, and a second communication path for communicating the nucleic acid amplification region and the nucleic acid detection region; the nucleic acid extraction region is configured to form the droplet to be detected under drive of the plurality of drive units, and extract a nucleic acid to be amplified from the droplet to be detected; the nucleic acid amplification region is configured to perform a polymerase chain reaction on the nucleic acid to be amplified under drive of the plurality of drive units to form an amplification product; and the nucleic acid detection region is configured to perform a hybridization reaction and a color development reaction on the amplification product under drive of the plurality of drive units, and obtain a hybridization color development signal for indicating whether a target gene exists in the droplet to be detected.
However, in the analogous art of processing cartridges, Corey et al. teaches a digital microfluidic nucleic acid detection chip (See the Abstract, the multiplex cartridge 10, and the Claim(s) 1-21 in [0004]-[0069], [0137]-[0560] in Fig. 1-60), wherein the functional region (See the sample preparation module 70 in [0153] in Fig. 1-4) at least comprises: a nucleic acid extraction region, a nucleic acid amplification region (See the reaction module 240 in [0158], [0385]-[0404] in Fig. 1-4),
a nucleic acid detection region (See how the upper shroud 12 further includes an inlet optical port 14 and an outlet optical port 16 to enable monitoring of fluid movement through a particular portion of the sample preparation module 70 in [0156] in Fig. 1-4),
a first communication path for communicating the nucleic acid extraction region and the nucleic acid amplification region, and a second communication path for communicating the nucleic acid amplification region and the nucleic acid detection region (See the various channels in [0153]-[0189] in Fig. 1-60);
the nucleic acid extraction region is configured to form the droplet to be detected under drive of the plurality of drive units, and extract a nucleic acid to be amplified from the droplet to be detected (See in [0137]-[0143], [0224]-[0248], [0386]);
the nucleic acid amplification region is configured to perform a polymerase chain reaction on the nucleic acid to be amplified under drive of the plurality of drive units to form an amplification product (See in [0385]-[0404]); and
the nucleic acid detection region is configured to perform a hybridization reaction and a color development reaction on the amplification product under drive of the plurality of drive units, and obtain a hybridization color development signal for indicating whether a target gene exists in the droplet to be detected (See the hybridization zone 370 in [0149], [0227], [0303]-[0404] in Fig. 26-27, 59).
Thus, it would be obvious to one with ordinary skills in the arts to modify the chip of Pang et al. by incorporating a functional region at least comprising: a nucleic acid extraction region, a nucleic acid amplification region, a nucleic acid detection region, and fluid paths (as taught by Corey et al.) for the benefit of performing colorimetric PCR using droplets on a detection chip.
Regarding Claim 18, Pang et al. teaches the detection chip limitations of claim 1.
Pang et al. fails to explicitly teach a digital microfluidic nucleic acid detection apparatus, comprising: a pipetting apparatus, a temperature control apparatus, a magnetic control apparatus, a signal acquisition and processing apparatus, and a digital microfluidic nucleic acid detection chip according to claim l; wherein the pipetting apparatus is configured to transfer a substance to the digital microfluidic nucleic acid detection chip, and the substance comprises: a sample solution or a reagent; the temperature control apparatus is configured to provide a set temperature to the digital microfluidic nucleic acid detection chip; the magnetic control apparatus is configured to provide a set magnetic field to the digital microfluidic nucleic acid detection chip; the signal acquisition and processing apparatus is connected with the digital microfluidic nucleic acid detection chip, and is configured to scan and image the hybridization color development signal formed by the digital microfluidic nucleic acid detection chip for indicating whether a target gene exists in a droplet to be detected to obtain a detection image; and analyze and process the detection image to obtain a detection result, and the detection result comprises a positive detection result for indicating a target gene exists in the droplet to be detected or a negative detection result for indicating no target gene exists in the droplet to be detected.
However, in the analogous art of processing cartridges, Corey et al. teaches a digital microfluidic nucleic acid detection apparatus (See the Abstract, the multiplex cartridge 10, and the Claim(s) 1-21 in [0004]-[0069], [0137]-[0560] in Fig. 1-60), comprising: a pipetting apparatus (See the ports 282, 289 used for injecting in [0208]-[0209] in Fig. 24-27),
a temperature control apparatus (See the thermocycling pathways 364a-d in [0248] in Fig. 59 and the detection Peltier assembly 540 in [0302] in Fig. 45),
a magnetic control apparatus, a signal acquisition and processing apparatus (See the cartridge processing assembly 470 and the processing module 240 in [0278]-[0281] in Fig. 38-41; Also, see the cartridge magnet assembly 552 in [0308]-[0383] in Fig. 49B), and a digital microfluidic nucleic acid detection chip according to claim l;
wherein the pipetting apparatus is configured to transfer a substance to the digital microfluidic nucleic acid detection chip (See the ports 282, 289 used for injecting in [0208]-[0209] in Fig. 24-27), and
the substance comprises: a sample solution or a reagent (See in [0385]-[0404] in Fig. 1-60);
the temperature control apparatus is configured to provide a set temperature to the digital microfluidic nucleic acid detection chip )(See the detection Peltier assembly 540 in [0302] in Fig. 45);
the magnetic control apparatus is configured to provide a set magnetic field to the digital microfluidic nucleic acid detection chip(See the cartridge magnet assembly 552 in [0308]-[0383] in Fig. 49B);
the signal acquisition and processing apparatus is connected with the digital microfluidic nucleic acid detection chip, and is configured to scan and image the hybridization color development signal formed by the digital microfluidic nucleic acid detection chip for indicating whether a target gene exists in a droplet to be detected to obtain a detection image; and analyze and process the detection image to obtain a detection result, and the detection result comprises a positive detection result for indicating a target gene exists in the droplet to be detected or a negative detection result for indicating no target gene exists in the droplet to be detected (See how the sensors 810, 812 are constructed and arranged to detect (e.g., generate a signal) fluid flow through inlet optical sensing chamber 154 and outlet optical sensing chamber 158 of the sample preparation module 70. Optical sensors 810, 812 may be connected to and at least partially controlled by the LED PCB 466 in [0337], [0373] in Fig. 15 and the Claim(s) 1-21; Also, see how the detector comprises an optical detector comprising an emitter 686 and detector 688 each disposed within a respective pocket on opposite sides of the cartridge holder 652. An optical beam from the emitter 686 to the detector 688 is broken when a multiplex cartridge is inserted into the cartridge holder 652, thereby generating a signal indicating the presence of the cartridge in [0199], [0264], [0282], [0293] in Fig. 2, 15, 38-41, 46 and Claim 14).
Thus, it would be obvious to one with ordinary skills in the arts to modify the chip of Pang et al. by incorporating a pipetting apparatus, a temperature control apparatus, a magnetic control apparatus, a signal acquisition and processing apparatus, and a detection image (as taught by Corey et al.) for the benefit of performing colorimetric PCR using droplets on a detection chip.
Regarding Claim(s) 19-20, Pang et al. teaches the detection chip limitations of claim 1.
Pang et al. fails to explicitly teach a digital microfluidic nucleic acid detection method, comprising: forming a droplet to be detected; and performing a nucleic acid detection processing on the droplet to be detected under drive of a plurality of drive units to obtain a hybridization color development signal for indicating whether a target gene exists in the droplet to be detected; wherein the method further comprises: acquiring a detection image obtained by scanning and imaging the hybridization color development signal by a signal acquisition and processing apparatus; and analyzing and processing the detection image to obtain a detection result, wherein the detection result comprises a positive detection result for indicating a target gene exists in the droplet to be detected or a negative detection result for indicating no target gene exists in the droplet to be detected.
However, in the analogous art of processing cartridges, Corey et al. teaches a digital microfluidic nucleic acid detection method (See the Abstract, the multiplex cartridge 10, and the Claim(s) 1-21 in [0004]-[0069], [0137]-[0560] in Fig. 1-60), comprising: forming a droplet to be detected; and performing a nucleic acid detection processing on the droplet to be detected under drive of a plurality of drive units to obtain a hybridization color development signal for indicating whether a target gene exists in the droplet to be detected; wherein the method further comprises: acquiring a detection image obtained by scanning and imaging the hybridization color development signal by a signal acquisition and processing apparatus; and analyzing and processing the detection image to obtain a detection result, wherein the detection result comprises a positive detection result for indicating a target gene exists in the droplet to be detected or a negative detection result for indicating no target gene exists in the droplet to be detected (See in [0385]-[0560] and the Claim(s) 1-20).
Thus, it would be obvious to one with ordinary skills in the arts to modify the chip of Pang et al. by incorporating a detection method comprising: forming and processing a droplet containing nucleic acids (as taught by Corey et al.) for the benefit of analyzing a colorimetric PCR on a detection chip.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRITNEY N WASHINGTON whose telephone number is (703)756-5959. The examiner can normally be reached Monday-Friday 7:00am - 3:30pm CT.
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/BRITNEY N. WASHINGTON/Examiner, Art Unit 1797
/JENNIFER WECKER/Primary Examiner, Art Unit 1797
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