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 .
Status of Claims
The claim set submitted on 02 DECEMBER 2025 is acknowledged and considered. In the claim set, Claims 1-3 are ‘Currently Amended’ ; and Claims 4-8 are ‘New’.
Current pending claims are Claims 1-8 and are considered on the merits below.
Response to Amendment
Applicant’s arguments with respect to Claims 1-3 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over NAGAI, EP 3 168 287 , published 17 MAY 2017, in view of LAFFERTY, US Patent 6,866,824 B2
Applicant’s invention is directed to a device, a nucleic acid amplification device.
Regarding Claim 1, the reference NAGAI discloses a nucleic acid amplification device on which a nucleic acid amplification chip is placed, abstract, Figure 2, [0019, 0020], the device comprising:
a micro-flow channel comprising an open system, Figure 2, [0019, 0020, 0045, 0046], microchannels;
temperature regulation units forming a denaturation temperature zone of the micro-flow channel and an extension and annealing temperature zone of the micro-flow channel, Figure 2, regions encompassed by dotted line, [0039];
liquid delivery mechanisms that equalize air pressures of an air suction portion and an air discharge portion when liquid delivery is stopped to reciprocally move the sample solution in the micro-flow channel between the denaturation temperature zone and the extension and annealing temperature zone, [00100019, 0020, 0022-0024, 0035, 0036, 0042], ;
a detection unit that is arranged to detect a sample solution in the micro-flow channel of the nucleic acid amplification chip, [0010, 0020, 0021, 0030, 0035, 0044, 0045]; and
a control unit that is arranged to control the liquid delivery mechanisms based on a detection result of the detection unit, [0020, 0024, 0032, 0036, 0082], wherein the detection unit includes an light source that is arranged to emit light, [0009, 0048], and a light detection element that is arranged to detect the light, [0009, 0048, 0069].
The NAGAI reference discloses the claimed invention but is silent in regards to wherein light source is an infrared light source to emit a infrared ray. In NAGAI, the light emits fluorescent light, [0009, 0048, 0069], Claim 5.
However, LAFFERTY teaches that is well known in the art to screen and identify bioactivities and bioactive molecules of interest, which can be read on nucleic acids. The device can be used for nucleic acid amplification, abstract, Column 13 line 50-56, Figure 2, the device comprising : a micro-flow channel, Figure 3, capillary, Column 21 line 12-20, a temperature regulation unit, Column 19 line 54-56, Column 21 line 9-11, Column 23 line 4-15; a detection unit that is arranged to detect a sample solution in the micro-flow channel of the nucleic acid amplification chip; and wherein the detection unit includes an infrared light source that is arranged to emit an infrared ray, Column 24 line 13-38; and a control unit, Column 65 line 32-34.
It would be obvious to one having ordinary skill in the art before the effective filing date to modify the NAGAI reference with the detection unit that includes an infrared light source that is arranged to emit an infrared ray as taught by LAFFERTY to provide precise control over the amplification process and detailed analysis over structural properties of the nucleic acid. In addition, the use of infrared light allows for detection of specific nucleic acid components and provides insights into the time dependent chemistry of DNA.
Additional Disclosures Included are: Claim 4: wherein the nucleic acid amplification device of claim 1, wherein the liquid delivery mechanisms comprise a microblower, [0019, 0020, 0024, 0035, 0036, 0042]. ; Claim 5: wherein the nucleic acid amplification device of claim 1, wherein the liquid delivery mechanisms comprise a fan, [0019, 0020, 0021, 0024]. ; Claim 6: wherein the nucleic acid amplification device of claim 1, wherein the infrared light source and the infrared detection element are disposed to face each other with a detection region of the micro-flow channel interposed therebetween, [0009], Figure 1 and 2, LAFFERTY Figure 3. ; Claim 7: wherein the nucleic acid amplification device of claim 6, wherein the detection region is disposed between the denaturation temperature zone and the extension and annealing temperature zone, [0020, 0032, 0039, 0045], Figure 2. ; and Claim 8: wherein the nucleic acid amplification device of claim 6, wherein the infrared detection element is arranged to detect infrared radiation that is transmitted through the micro-flow channel, LAFFERTY, Column 24 line 13-38. It would be obvious to one having ordinary skill in the art before the effective filing date to modify the NAGAI reference with the infrared detection element is to detect infrared radiation through the micro-flow channel as taught by LAFFERTY to provide precise control over the amplification process and detailed analysis over structural properties of the nucleic acid. In addition, the use of infrared light allows for detection of specific nucleic acid components and provides insights into the time dependent chemistry of DNA.
Applicant’s invention is directed to a method.
Regarding Claim 2 , the NAGAI reference discloses a nucleic acid amplification method using a thermal cycle, abstract, [0007, 0010, 0019, 0020], in which a sample solution is reciprocated between a denaturation temperature zone and an extension and annealing temperature zone, [0020], the method comprising:
a temperature regulation step of forming the denaturation temperature zone and the extension and annealing temperature zone, [0020] ;
a liquid delivery step of moving the sample solution in a micro-flow channel so as to reciprocate between the denaturation temperature zone and the extension and annealing temperature zone by means of liquid delivery mechanisms that equalize air pressures of an air suction portion and an air discharge portion when liquid delivery is stopped, [0020];
a detection step of detecting the sample solution in a nucleic acid amplification chip, [0010, 0020, 0021, 0030, 0035, 0044, 0045]; and
a control step of controlling the liquid delivery mechanisms based on a detection result of the detection step, [0020, 0024, 0032, 0036, 0082], wherein in the detection step, an light source irradiates the micro-flow channel with a light, and an detection element detects the light ray that has transmitted through the micro-flow channel, [0009, 0048], wherein the method is performed on the nucleic acid amplification device of claim 1, see Rejection to Claim 1.
The NAGAI reference discloses the claimed invention but is silent in regards to wherein light source is an infrared light source to emit a infrared ray. In NAGAI, the light emits fluorescent light.
However, LAFFERTY teaches that is well known in the art to screen and identify bioactivities and bioactive molecules of interest, which can be read on nucleic acid. The device can be used for nucleic acid amplification, abstract, Column 13 line 50-56, Figure 2, the device comprising : a micro-flow channel, Figure 3, capillary, Column 21 line 12-20, a temperature regulation unit, Column 19 line 54-56, Column 21 line 9-11, Column 23 line 4-15; a detection unit that is arranged to detect a sample solution in the micro-flow channel of the nucleic acid amplification chip; and wherein the detection unit includes an infrared light source that is arranged to emit an infrared ray, Column 24 line 13-38; and a control unit, Column 65 line 32-34.
It would be obvious to one having ordinary skill in the art before the effective filing date to modify the NAGAI reference with the detection unit that includes an infrared light source that is arranged to emit an infrared ray as taught by LAFFERTY to provide precise control over the amplification process and detailed analysis over structural properties of the nucleic acid. In addition, the use of infrared light allows for detection of specific nucleic acid components and provides insights into the time dependent chemistry of DNA.
Applicant’s invention is directed to a method.
Regarding Claim 3, the reference NAGAI discloses a sample solution position control method , [0007, 0010, 0019, 0020], comprising:
a liquid delivery step of moving a sample solution in a micro-flow channel by means of liquid delivery mechanisms that equalize air pressures of an air suction portion and an air discharge portion when liquid delivery is stopped, [0019, 0020], Claims 4-10;
an light detection step of irradiating the micro-flow channel with an light ray, and detecting the light ray that has transmitted through the micro-flow channel, [0019, 0020], Claims 4-10; and
a position control step of controlling a position of the sample solution in the micro-flow channel by controlling a driving of the liquid delivery mechanisms based on a change in an amount of the light ray detected in the infrared detection step, [0019, 0020], Claims 4-10,wherein the method is performed on the nucleic acid amplification device of claim 1, see Rejection to Claim 1.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE T MUI whose telephone number is (571)270-3243. The examiner can normally be reached M-Th 5:30 -15:30 EST.
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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797