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 .
Drawings
Figure 10 should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liu (WO 0171331 A1).
In regards to claim(s) 1, Liu discloses a microchip electrophoresis (title) method comprising: in order, a preparation step of preparing a chip for electrophoresis including a sample introduction channel (102; Fig. 1b) extending in a first direction and a sample separation channel (101; Fig. 1b) extending in a second direction intersecting the first direction (at 103; Fig. 1b);
a filling step of filling the sample introduction channel and the sample separation channel with a separation medium for electrophoresis (“During a typical microchip electrophoretic operation, the migration channels 101-103 are first filled with suitable buffer.”; p. 2, lines 25-27)
an introduction step of introducing a sample into the sample introduction channel and applying voltage to the sample introduction channel so as to generate potential gradient in the first direction in the sample introduction channel, and thus filling the entire sample introduction channel with the sample (“A voltage is applied across channel 102 between holes 113 and 114 for a specified period of time, which allows dispersion of the sample across channel 102 and, especially, into channel 103.”; p. 2, lines 28-31);
and a separation step of separating a target substance in the sample by applying voltage into the sample separation channel so that potential gradient is generated in the second direction in the sample separation channel (“A higher voltage is then applied across the main separation channel 101 between holes 111 and 112”; p. 2, lines 31-33),
wherein the sample introduction channel includes: an upstream side channel (top channel 102; “A sample is then injected into channel 102 through hole 113.”; Figs. 1a-1b; p. 2, lines 27-28) extending in the first direction; a cross channel (103; Fig. 1b) extending in the second direction from a first direction downstream side end portion of the upstream side channel; and a downstream side channel (bottom channel 102; Fig. 1b) extending in the first direction from a second direction downstream side end portion of the cross channel, the sample separation channel (101 flows from 111 to 112, Figs. 1a-1b; “The bands will be detected at a detection position (not shown) near the end of channel 101/hole 112” p. 2, line 35 to p. 3, line 2) shares the cross channel in a middle thereof (103),
and in the introduction step, voltage is applied to the sample separation channel such that potential in the cross channel is higher than potential on the second direction upstream side and the second direction downstream side of the cross channel, and such that potential gradient on the second direction upstream side of the cross channel is larger than potential gradient on the second direction downstream side of the cross channel (in the introduction step of Liu, voltage is applied between holes 113 and 114 and no voltage is applied yet between 111 and 112; thus potential is higher in the cross channel than the either of the left 101 or the right 101. Additionally, since the value of the potential is “x” and no potential is applied yet to 111 or 112, both 111 and 112 are zero. The distance to the left (111; upstream) is far less than the distance to the right (112; downstream). Since the potential gradient is calculated as potential difference / distance, the gradient to the upstream/left side (111) is greater than to the downstream/right side (112).
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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.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu (WO 0171331 A1) in view of Kinoshita (JP 2019148564 A).
In regards to claim(s) 2, Liu discloses the potential gradient difference between the left/upstream side and the right/downstream side as explained for claim 1. However, Liu does not disclose the actual distance values of the upstream channel and the downstream channel, nor the sample injection voltage.
Kinoshita pertains to electrophoresis (abstract) and is therefore in the same field of endeavor as Liu. Kinoshita discloses “On the other hand, as the voltage at the time of sample introduction or electrophoresis, an optimal voltage was experimentally selected from the voltage programs installed in the software incorporated in the microchip electrophoresis apparatus used.” (p. 5). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have optimized the sample injection voltage based upon experimentation as suggested by Kinoshita. Since well known equipment was used (MCE-202 manufactured by Shimadzu Corporation used as microchip electrophoresis), achieving the instantly claimed differential of 20 V/cm to 70 V/cm would have been expected. See MPEP 2144.05 II.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu (WO 0171331 A1) in view of Shahrokh (US 20160032273 A1)
In regards to claim(s) 3, Liu does not disclose wherein the target substance is short-chain RNA, nor is there a thermal denaturation step to perform heating to straighten the target substance.
Shahrokh pertains to electrophoresis (abstract) and is therefore in the same field of endeavor as Liu. Shahrokh discloses analyzing a target substance of siRNAs ([0108]). Shahrokh discloses thermal denaturation ([0143]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have select siRNA as the target substance as suggested by Shahrokh as it is a common target of interest and it would have been obvious to thermal denature the target because Shahrokh teaches such is a preferred method of denaturing the RNA for analytical purposes (Shahrokh, [0143]).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu (WO 0171331 A1) in view of Arai (US 20190101508 A1).
In regards to claim(s) 4, Liu does not disclose that the separation medium contains a water-soluble cellulose derivative and sugar alcohol.
Arai pertains to electrophoresis (abstract) and is therefore in the same field of endeavor as Liu. Arai discloses that the separation medium contains a water-soluble cellulose derivative and sugar alcohol (abstract). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the separation medium of Liu with Arai’s separation medium because all claimed elements were known, each element merely performs the same function as it does separately (allows separation of a target substance) and one of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143 I (A).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICHOLAS A SMITH whose telephone number is (571)272-8760. The examiner can normally be reached M-F 7:30am-3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Srilakshmi Kumar can be reached at (571)272-7769. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICHOLAS A SMITH/Supervisory Primary Examiner, Art Unit 1752
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