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 .
Preliminary Amendments
Applicant’s preliminary amendment filed on December 3, 2024 is acknowledged. Claims 1-6 are currently pending.
Claim Objections
Claim(s) 1-2 is/are objected to because of the following informalities:
Claim 1, lines 5-6: “a pre-run” should be “the first pre-run step”
Claim 1, line 8: “the pre-run” should be “the first pre-run step”
Claim 2, lines 5-6: “a pre-run” should be “the first pre-run step”
Claim 2, line 8: “the pre-run” should be “the first pre-run step”
Appropriate correction is required.
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.
Claim(s) 1 and 3-4 is/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 pre-AIA the applicant regards as the invention.
Claim 1 recites the limitation " a pre-run " in lines 12-13. It is unclear whether this pre-run is the first pre-run or the second pre-run. It is suggested to be “the second pre-run step.”
Dependent claim(s) 3-4 is/are rejected based on rejected claim 1.
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Imai (JPH11-108889, machine translation used for citation).
Regarding claim 2, Imai teaches a method for continuously using a separation medium (¶5: the apparatus is repeatedly used for a plurality of analyses without replacing a gel; ¶29: the overall operation of the electrophoresis analysis apparatus), the method comprising:
a separation medium filling step of filling a capillary with the separation medium (¶6: capillary filled with an electrophoresis medium);
a first pre-run step of applying a voltage (¶29: preliminary electrophoresis before measurement is performed when the standard sample and the analysis sample are not introduced) in the same direction as that in which electrophoresis is to be performed to the capillary filled with the separation medium to perform a pre-run (¶29: in the preliminary migration, the voltage applied from the power source is 120V/cm; ¶33: the separation electrophoresis voltage is 120V/cm; thus the voltages are in the same direction);
a first sample injection step of injecting a first-time sample into the capillary subjected to the pre-run (¶31: the sample is introduced);
a first electrophoretic step of applying a voltage to the capillary into which the first-time sample has been injected to perform first electrophoresis (¶30: the sample introduced into the capillary is separated by electrophoresis);
a second sample injection step of injecting a next-time sample into the capillary after the first electrophoretic step; and a second electrophoretic step of applying a voltage to the capillary into which the next- time sample has been injected to perform next electrophoresis (¶35: when the analysis of the sample in the sample tray 100A is completed, the samples in the sample trays 100B and 100C are introduced into the capillary and separated by electrophoresis in the same procedure),
wherein, after repeatedly performing the second sample injection step and the second electrophoretic step a preliminarily set number of times, the method ends analysis (¶36: since it takes about two hours to analyze one sample, by installing three sample trays 100A, 100B, 100C on the sample tray holder, automatic analysis of about six hours becomes possible).
Imai does not explicitly disclose the method ends analysis using the separation medium with which the capillary is filled in the separation medium filling step performed once, then returns to the separation medium filling step to replace the separation medium in the capillary, and performs each of the steps including and subsequent to the first pre-run step by using a new separation medium an intended number of times.
However, Imai teaches in the conventional method, the filled gel is consumed for each measurement and is replaced every time, which requires time and is difficult to automatically analyze a plurality of samples (¶3). When the same gel is repeatedly used a plurality of times, the reliability of data cannot be ensured due to deterioration in performance (¶4). Imai’s invention ensures the reliability of data even when the apparatus is repeatedly used for a plurality of analyses without replace the gel (¶5) with capillary determination means to determining whether the state of the capillaries is good or bad (¶6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Imai by refilling a new separation medium when a new gel is required, i.e., after a certain number of runs using the sample separation medium in the capillary and determining the state of the capillary is not good, because it is a known technique to determine if a new separation medium is required for refilling to maintain the separation performance and applying a known technique to a known method ready for improvement to yield predictable results is prima facie obvious. MPEP 2141(III)(D). Here, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP 2143(I)(A).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Imai in view of Bancaud (US 2015/0204816).
Regarding claim 5, Imai discloses all limitation of claim 2, but fails to teach wherein the separation medium is a liquid polymer.
However, Bancaud teaches a separating matrix is in fact a medium such as a gel or a polymer solution which allows an electrophoretic separation to be carried out (¶80).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Imai by substituting the separation medium with one of polymer solution as taught by Bancaud. The suggestion for doing so would have been that polymer solution is a suitable material for separation matrix of electrophoresis and the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. MPEP § 2144.07.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Imai in view of Terakado (US 2020/0249199).
Regarding claim 6, Imai discloses all limitation of claim 2, but fails to teach wherein a frequency of filling with the separation medium in the separation medium filling step is set via a graphical user interface.
However, Terakado teaches the sieving matrix information is displayed by the GUI and the user may read the information, removing the old and attaching new sieving matrix cartridge, and pressing a filling start button on a screen for starting a filling (Fig. 5; ¶48). The filling is started and a filling rate of the sieving matrix is displayed at any time till the filling rate reaches 100% (Fig. 5; ¶48). Thus, Terakado teaches using a graphical user interface (GUI) to instruct the apparatus to operate the capillary electrophoresis apparatus, so that continuous use such as automatic filling and exchanging of a sieving matrix has been possible (¶3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Imai by instructing the capillary electrophoresis apparatus to operate via GUI as taught by Terakado because it would enable the operation in a continuous and automatic operation. Since the GUI allows for inputting instructions, for example, reading the sieving matrix information, exchanging cartridge, starting filling the sieving matrix, etc., it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to inputting the instruction on the frequency of filling with the separation medium. Here, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP 2143(I)(A).
Allowable Subject Matter
Claim(s) 1 and 3-4 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The prior art does not disclose nor render obvious all of the cumulative limitations of claims 1 and 3-4 with particular attention to the limitations:
a second pre-run step of applying a voltage in the same direction as that in which electrophoresis is to be performed to the capillary after the first electrophoretic step to perform a pre-run (claim 1).
Here, Imai teaches a method for continuously using a separation medium (¶¶5, 29), the method comprising: a separation medium filling step of filling a capillary with the separation medium (¶6: capillary filled with an electrophoresis medium); a first pre-run step of applying a voltage (¶29: preliminary electrophoresis before measurement is performed when the standard sample and the analysis sample are not introduced) in the same direction as that in which electrophoresis is to be performed to the capillary filled with the separation medium to perform a pre-run (¶29: in the preliminary migration, the voltage applied from the power source is 120V/cm; ¶33: the separation electrophoresis voltage is 120V/cm; thus the voltages are in the same direction); a first sample injection step of injecting a first-time sample into the capillary subjected to the pre-run (¶31: the sample is introduced); a first electrophoretic step of applying a voltage to the capillary into which the first-time sample has been injected to perform first electrophoresis (¶30: the sample introduced into the capillary is separated by electrophoresis); a second sample injection step of injecting a next-time sample into the capillary after the first electrophoretic step; and a second electrophoretic step of applying a voltage to the capillary into which the next- time sample has been injected to perform next electrophoresis (¶35: when the analysis of the sample in the sample tray 100A is completed, the samples in the sample trays 100B and 100C are introduced into the capillary and separated by electrophoresis in the same procedure), wherein, after repeatedly performing the second sample injection step and the second electrophoretic step a preliminarily set number of times (¶36: since it takes about two hours to analyze one sample, by installing three sample trays 100A, 100B, 100C on the sample tray holder, automatic analysis of about six hours becomes possible). However, Imai does not teach a second pre-run of applying a voltage in the same direction in which electrophoresis is to be performed.
Conclusion
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/C. SUN/Primary Examiner, Art Unit 1795
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