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 the Claims
Claims 1-2, 4-5, 7-8, and 10-13 have been amended. Claims 1-2 and 4-13 are currently examined herein.
Status of the Rejection
All U.S.C. 112(f) interpretations and U.S.C. 112(b) rejections from the previous office action are withdrawn in view of the amendments.
New grounds of claim objection and 35 U.S.C. § 112(b) are necessitated by Applicant’s amendments.
All 35 U.S.C. § 101 and 35 U.S.C. § 103 rejections are essentially maintained and modified only in response to Applicant’s amendments.
Claim Objections
Claim 6 is objected to because of the following informalities:
Claim 6, please amend “wherein the electrophoresis apparatus is configured to measure a plurality of the objects-to-be-measured, and in a case” to -- wherein .
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.
Claims 1-2 and 4-13 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 1, “the device error” lacks antecedent basis. In addition, the limitation “an error, the error including the apparatus error and the analysis error” is unclear if “the error” can include only the analysis error, only the apparatus error, or both the analysis error and the apparatus error. In addition, claim 1 recites “a correspondence in an identifiable manner”, and it is unclear if “the correspondence” is the same or different from “the error, including the apparatus error and the analysis error”. Claims 2 and 4-11 are further rejected by virtue of their dependence upon and because they fail to cure the deficiencies of indefinite claim 1.
Regarding Claim 12, “the device error” lacks antecedent basis. In addition, the limitation “an error, the error including the apparatus error and the analysis error” is unclear if “the error” can include only the analysis error, only the apparatus error, or both the analysis error and the apparatus error. In addition, claim 12 recites “a correspondence in an identifiable manner”, and it is unclear if “the correspondence” is the same or different from “the error, including the apparatus error and the analysis error”.
Regarding Claim 13, “the device error” lacks antecedent basis. In addition, the limitation “an error, the error including the apparatus error and the analysis error” is unclear if “the error” can include only the analysis error, only the apparatus error, or both the analysis error and the apparatus error. In addition, claim 13 recites “a correspondence in an identifiable manner”, and it is unclear if “the correspondence” is the same or different from “the error, including the apparatus error and the analysis error”.
Claim Rejections - 35 USC § 101
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-2 and 4-13 are rejected under 35 U.S.C. 101.
Regarding Independent Claim 1, claim 1 is rejected under 35 U.S.C 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claim 1 is directed to an electrophoresis system with an analysis apparatus that “in a case where at least one of the apparatus error or the analysis error is detected, the analysis apparatus is configured to display an abnormality detection indication that indicates types of the detected abnormalities so that the apparatus error and the analysis error are mutually identifiable” and “the analysis apparatus is configured to display a correspondence in an identifiable manner and to display the device error and the analysis error in an identifiable manner, the correspondence being between each of the plurality of the well position displays displayed on the display or each of the plurality of the gel image displays, and an error, the error including the apparatus error and the analysis error”, which are abstract concepts that can be done mentally. The additional structural limitations such as an “electrophoresis system”, “electrophoresis apparatus”, “analysis apparatus”, “abnormality detector”, and “a display” are known as evidenced by the prior art of ABI 3130xl (Applied Biosystems 3130/3130xl Genetic Analyzers, May 2012) in the prior art rejection of claim 1 below, and are conventional structures previously known to the pertinent industry that serve to obtain the measured values of electrophoresis signals, analysis of the measured signals, and display the analysis results. Furthermore, the additional elements are used to gather data and analyzing/classifying data (i.e., an abnormality) and are insignificant. Section 2106.04(a)(2) of MPEP states: “Certain Methods of Organizing Human Activity, including managing relationships and legal obligations, advertising and marketing, managing human behavior, and collecting, analyzing, classifying, and storing data” is directed to an abstract idea.
Claim 1 is Ineligible due to the following analysis:
Step 1 (Statutory Category): Claim 1 is directed to an electrophoresis system, therefore, it is directed to a statutory category, i.e., an apparatus (Step 1: YES).
Step 2A, Prong-1 (the claim is evaluated to determine whether it is directed to a judicial-exception/abstract-idea): Claim 1 recites: “in a case where at least one of the apparatus error or the analysis error is detected, the analysis apparatus is configured to display an abnormality detection indication that indicates types of the detected abnormalities so that the apparatus error and the analysis error are mutually identifiable” and “the analysis apparatus is configured to display a correspondence in an identifiable manner and to display the device error and the analysis error in an identifiable manner, the correspondence being between each of the plurality of the well position displays displayed on the display or each of the plurality of the gel image displays, and an error, the error including the apparatus error and the analysis error”, which are abstract ideas since the analysis apparatus just uses measured values, such as signals from an electrophoresis run, to determine if an abnormality exists, thus is a mental step, and then displays the error as either and apparatus error or and analysis error. Therefore, it is directed to a judicial exception/abstract-idea (Step 2A, Prong-1: YES).
Step 2A, Prong-2 (the claim is evaluated to determine whether the judicial-exception/abstract-idea is integrated into a Practical Application): the abstract idea related to “in a case where at least one of the apparatus error or the analysis error is detected, the analysis apparatus is configured to display an abnormality detection indication that indicates types of the detected abnormalities so that the apparatus error and the analysis error are mutually identifiable” and “the analysis apparatus is configured to display a correspondence in an identifiable manner and to display the device error and the analysis error in an identifiable manner, the correspondence being between each of the plurality of the well position displays displayed on the display or each of the plurality of the gel image displays, and an error, the error including the apparatus error and the analysis error”, is not used into a practical application, and do not belong to a particular technological environment, industry or field since nothing is done after the mental step. Data gathering to be used in the abstract idea is insignificant extra-solution activity, and not a particular practical application. Furthermore, displaying analysis results and an abnormality detection indication is not a practical application, which is more like the alarm in Parker V. Flook. Consequently, the aforesaid abstract idea is not integrated into a practical application and/or apply, rely on, and/or use to an additional element or elements in a manner that imposes a meaningful limit, thus, monopolizing the steps (Step 2A, Prong-2: NO, because there is no integration of the abstract idea into a practical application).
Step 2B (the claim is evaluated to determine whether recites additional elements that amount to an inventive concept, or also, the additional elements are significantly more than the recited the judicial-exception/abstract-idea): Claim 1 recites the additional element(s): “an electrophoresis system, an electrophoresis apparatus, a channel, a separation channel, a measurer, an analysis apparatus, an abnormality detector, a display, and a plurality of objects-to-be-measured”, which are routine and conventional structures previously known to the pertinent industry that serve to obtain measurement signals from an electrophoretic run and electrophoresis apparatus instrument parameters, which are used to determine if the electrophoresis signal and/or apparatus system parameters are operating normally, by an arithmetic device such as CPU executing software based on the mathematical equation(s). Therefore, claim 1 does not include additional element(s) significantly more, and/or, does not amount to more than the judicial-exception/abstract-idea itself and the claim is not patent eligible (Step 2B: NO).
Regarding dependent claims 2 and 4-11, claims 2 and 4-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 2 and 4-11 depend on the independent claim 1, therefore, have the abstract idea of claim 1 and also have the routine and conventional structures above of claim 1.
Claim 2 recites “the electrophoresis apparatus is configured to output an apparatus error signal” and “display the abnormality detection indication on the display”. Outputting error signal and displaying abnormality detection indication are not a practical application, which is more like the alarm in Parker V. Flook.
Claims 4-5 recite different ways to display the abnormality (Claim 4 – different display mode depending on degree of importance; Claim 5 – display using color-coding or an icon image), which are just mental steps and ways of classifying the data. Outputting error signal and displaying abnormality detection indication are not a practical application, which is more like the alarm in Parker V. Flook.
Claim 6 recites “the electrophoresis apparatus is configured to measure a plurality of the objects-to-be-measured”, which is known in the prior art as electrophoresis systems can use, for example, a capillary array measuring multiple samples simultaneously (see claim 6 rejection below). Furthermore, data gathering to be used in the abstract idea is insignificant extra-solution activity, and not a particular practical application.
Claim 7 recites “the analysis apparatus is configured to display…a standby indication indicating the object-to-be-measured”, which is a mental step and a different way of classifying the data. Outputting error signal and displaying abnormality detection indication are not a practical application, which is more like the alarm in Parker V. Flook.
Claim 8 recites “display, on the display, a well position display… and a gel image display”, which are common displays used in electrophoresis instruments (see claim 8 rejection below). Claim 8 also recites “display the abnormality detection that allows identification of the object-to-be-measured”, which are just mental steps and ways of classifying the data. Outputting error signal and displaying abnormality detection indication are not a practical application, which is more like the alarm in Parker V. Flook.
Claims 9-10 recite variations on how to display the abnormality (Claim 9 recites “display the abnormality detection in the gel image including a well number”; Claim 10 recites “display the abnormality detection indication in each of the plurality of analysis displayed side by side in the gel image display”), which are just mental steps and additional ways of classifying the data. Outputting error signal and displaying abnormality detection indication are not a practical application, which is more like the alarm in Parker V. Flook.
Claim 11 recites an additional structure of “an operation unit”, which is well known in the art (for example, a keyboard and mouse as outlined in the claim 11 rejection below), and further recites “the analysis apparatus is configured to display, on the display, the well position display…and display the abnormality detection indication when an abnormality is detected, for each of the plurality of wells arranged in the grid pattern in the well position display”, which are just mental steps and ways of classifying the data. Outputting error signal and displaying abnormality detection indication are not a practical application, which is more like the alarm in Parker V. Flook
In summary, dependent claims 2 and 4-11 do not include additional steps that are sufficient to amount to significantly more than the judicial exception.
Regarding Independent Claim 12, claim 12 is rejected under 35 U.S.C 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claim 12 is directed to an electrophoresis apparatus that “in a case where at least one of the apparatus error or the analysis error is detected, the analysis apparatus is configured to display an abnormality detection indication that indicates types of the detected abnormalities so that the apparatus error and the analysis error are mutually identifiable” and “the analysis apparatus is configured to display a correspondence in an identifiable manner and to display the device error and the analysis error in an identifiable manner, the correspondence being between each of the plurality of the well position displays displayed on the display or each of the plurality of the gel image displays, and an error, the error including the apparatus error and the analysis error”,, which are abstract concepts that can be done mentally. The additional structural limitations such as an “electrophoresis apparatus”, “measurer”, and “a display” are known as evidenced by the prior art of ABI 3130xl in the prior art rejection of claim 12 below, and are conventional structures previously known to the pertinent industry that serve to obtain the measured values of electrophoresis signals, analysis of the measured signals, and display the analysis results. Furthermore, the additional elements are used to gather data and analyzing/classifying data (i.e., an abnormality) and are insignificant. Section 2106.04(a)(2) of MPEP states: “Certain Methods of Organizing Human Activity, including managing relationships and legal obligations, advertising and marketing, managing human behavior, and collecting, analyzing, classifying, and storing data” is directed to an abstract idea.
Claim 12 is Ineligible due to the following analysis:
Step 1 (Statutory Category): Claim 12 is directed to an electrophoresis apparatus, therefore, it is directed to a statutory category, i.e., an apparatus (Step 1: YES).
Step 2A, Prong-1 (the claim is evaluated to determine whether it is directed to a judicial-exception/abstract-idea): Claim 12 recites: “in a case where at least one of the apparatus error or the analysis error is detected, the analysis apparatus is configured to display an abnormality detection indication that indicates types of the detected abnormalities so that the apparatus error and the analysis error are mutually identifiable” and “the electrophoresis apparatus is configured to display a correspondence in an identifiable manner and to display the device error and the analysis error in an identifiable manner, the correspondence being between each of the plurality of the well position displays displayed on the display or each of the plurality of the gel image displays, and an error, the error including the apparatus error and the analysis error”, which are abstract ideas since the electrophoresis apparatus just uses measured values and abnormality detection unit, such as measured values from the measurement unit, to determine if an abnormality exists, thus is a mental step. Therefore, it is directed to a judicial exception/abstract-idea (Step 2A, Prong-1: YES).
Step 2A, Prong-2 (the claim is evaluated to determine whether the judicial-exception/abstract-idea is integrated into a Practical Application): the abstract idea related to “in a case where at least one of the apparatus error or the analysis error is detected, the analysis apparatus is configured to display an abnormality detection indication that indicates types of the detected abnormalities so that the apparatus error and the analysis error are mutually identifiable” and “the analysis apparatus is configured to display a correspondence in an identifiable manner and to display the device error and the analysis error in an identifiable manner, the correspondence being between each of the plurality of the well position displays displayed on the display or each of the plurality of the gel image displays, and an error, the error including the apparatus error and the analysis error”, is not used into a practical application, and do not belong to a particular technological environment, industry or field since nothing is done after the mental step. Data gathering to be used in the abstract idea is insignificant extra-solution activity, and not a particular practical application. Furthermore, displaying analysis results and an abnormality detection indication is not a practical application, which is more like the alarm in Parker V. Flook. Consequently, the aforesaid abstract idea is not integrated into a practical application and/or apply, rely on, and/or use to an additional element or elements in a manner that imposes a meaningful limit, thus, monopolizing the steps (Step 2A, Prong-2: NO, because there is no integration of the abstract idea into a practical application).
Step 2B (the claim is evaluated to determine whether recites additional elements that amount to an inventive concept, or also, the additional elements are significantly more than the recited the judicial-exception/abstract-idea): Claim 12 recites the additional element(s): “an electrophoresis apparatus, a measurer, a channel, a separation channel, an abnormality detector, a display, and a plurality of objects-to-be-measured”, which are just routine and conventional structures previously known to the pertinent industry that serve to obtain measurement signals from an electrophoretic run and electrophoresis apparatus instrument parameters, which are used to determine if the electrophoresis signal and/or apparatus system parameters are operating normally. Data gathering to be used in the abstract idea is insignificant extra-solution activity, and not a particular practical application. Furthermore, displaying an abnormality detection indication is not a practical application, which is more like the alarm in Parker V. Flook. Therefore, claim 12 does not include additional element(s) significantly more, and/or, does not amount to more than the judicial-exception/abstract-idea itself and the claim is not patent eligible (Step 2B: NO).
Regarding Independent Claim 13, claim 13 is rejected under 35 U.S.C 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claim 13 is directed to an electrophoresis analysis method, the method comprising “a step of, in a case where at least one of the apparatus error or the analysis error is detected, displaying an abnormality detection indication that indicates types of the detected abnormalities so that the apparatus error and the analysis error are mutually identifiable” and “the step of displaying the abnormality detection indication on the display includes to display a correspondence in an identifiable manner and to display the device error and the analysis error in an identifiable manner, the correspondence being between each of the plurality of the well position displays displayed on the display or each of the plurality of the gel image displays, and an error, the error including the apparatus error and the analysis error”, which are abstract concepts that can be done mentally. Section 2106.04(a)(2) of MPEP states: “Certain Methods of Organizing Human Activity, including managing relationships and legal obligations, advertising and marketing, managing human behavior, and collecting, analyzing, classifying, and storing data” is directed to an abstract idea.
Claim 13 is Ineligible due to the following analysis:
Step 1 (Statutory Category): Claim 13 is directed to an electrophoresis analysis method, therefore, it is directed to a statutory category, i.e., a method/process (Step 1: YES).
Step 2A, Prong-1 (the claim is evaluated to determine whether it is directed to a judicial-exception/abstract-idea): Claim 13 recites: “a step of, in a case where at least one of the apparatus error or the analysis error is detected, displaying an abnormality detection indication that indicates types of the detected abnormalities so that the apparatus error and the analysis error are mutually identifiable” and “the step of displaying the abnormality detection indication on the display includes to display a correspondence in an identifiable manner and to display the device error and the analysis error in an identifiable manner, the correspondence being between each of the plurality of the well position displays displayed on the display or each of the plurality of the gel image displays, and an error, the error including the apparatus error and the analysis error”, which are abstract ideas in the form of a mental step. Therefore, it is directed to a judicial exception/abstract-idea (Step 2A, Prong-1: YES).
Step 2A, Prong-2 (the claim is evaluated to determine whether the judicial-exception/abstract-idea is integrated into a Practical Application): the abstract ideas related to “a step of, in a case where at least one of the apparatus error or the analysis error is detected, displaying an abnormality detection indication that indicates types of the detected abnormalities so that the apparatus error and the analysis error are mutually identifiable” and “the step of displaying the abnormality detection indication on the display includes to display a correspondence in an identifiable manner and to display the device error and the analysis error in an identifiable manner, the correspondence being between each of the plurality of the well position displays displayed on the display or each of the plurality of the gel image displays, and an error, the error including the apparatus error and the analysis error”, is not used into a practical application, and do not belong to a particular technological environment, industry or field since nothing is done after the mental step. Displaying an abnormality detection indication is not a practical application, which is more like the alarm in Parker V. Flook. Consequently, the aforesaid abstract idea is not integrated into a practical application and/or apply, rely on, and/or use to an additional step or steps in a manner that imposes a meaningful limit, thus, monopolizing the steps (Step 2A, Prong-2: NO, because there is no integration of the abstract idea into a practical application).
Step 2B (the claim is evaluated to determine whether recites additional elements that amount to an inventive concept, or also, the additional elements are significantly more than the recited the judicial-exception/abstract-idea): Claim 13 recites the additional step(s): “a step of analyzing a component of an object-to-be-measured separated by electrophoresis”; “a measurement value obtained by measuring the object-to-be-measured separated by electrophoresis in a channel including a separation channel for separating the object-to-be-measured”; “a step of measuring a plurality of objects-to-be-measured”, which are known to one of or new skill that only serves to collect/gather the data (i.e., gather the electropherogram signal/run), which is then used to perform the mental step of “abnormality detection indication” if an abnormality exits. Section 2106.04(a)(2) of MPEP states “Certain Methods of Organizing Human Activity, including managing relationships and legal obligations, advertising and marketing, managing human behavior, and collecting, analyzing, classifying, and storing data” is directed to an abstract idea. Therefore, the additional step of data collecting, “analyzing a component…separated by electrophoresis”, does not include additional element(s) significantly more, and/or, does not amount to more than the judicial-exception/abstract-idea itself and the claim is not patent eligible (Step 2B: NO).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-2, 4-8, 10, and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable ABI 3130xl (Applied Biosystems 3130/3130xl Genetic Analyzers, May 2012) in view of MultiNA (Microchip Electrophoresis System for DNA/RNA Analysis: Instruction Manual; 2013). ABI 3130xl Troubleshoot (Applied Biosystems 3130/3130xl Genetic Analyzers Maintenance, Troubleshooting, and Reference Guide, 2010) is used as an evidence reference for claim 2. KB Basecaller (Sequencing Analysis Software with KB Basecaller, 2007) is used as an evidence reference for claims 8 and 13.
Regarding Claim 1, ABI 3130xl teaches an electrophoresis system (electrophoresis system including 3130/3130xl electrophoresis instrument and associated equipment illustrated on page 10) comprising:
an electrophoresis apparatus (3130/3130xl Genetic Analyzer [page 10]) including a measurer (laser detection unit to measure fluorescence [page 20]) that measures an object-to-be-measured (object-to-be-measured is a sample, such as a sample of various DNA lengths [see Dye Set E sequencing standard sample as an example on page 60]) separated by electrophoresis in a channel including a separation channel for separating the object-to-be-measured (capillary is used as a channel including a separation channel for separating a sample to be measured [see electropherogram on page 129]), a channel (capillary [page 20]) including a separation channel;
an analysis apparatus (analysis apparatus includes CPU for control, a keyboard and mouse for operation, and a monitor for display [page 10]) that analyzes a component of the object-to-be-measured separated by electrophoresis (CPU analyzes, for example, a four-color DNA sample using an analysis protocol [page 74]), based on a measurement value of the object-to-be-measured that is measured by the measurer (sequence is determined based on DNA peak height [page 75]); and
a display (a monitor [page 10]) that displays an analysis result of the object-to-be-measured by the analysis apparatus (basecalling DNA sequence is displayed, as illustrated on page 74);
the electrophoresis apparatus includes an abnormality detector (EP Current Sensor, EP Voltage, and Oven Temperature Sensors [see Instrument Status pane, page 124]) configured to output a detection signal (as illustrated in instrument status chart on page 126, current is constantly measured throughout the run) for detecting an apparatus error that is an abnormality in the electrophoresis apparatus (current can be monitored in an electrophoresis run to see any errors in current or current leaks) , the abnormality detector provided separately from the measurer (detection cell block, which only includes the laser and capillary windows for measurement [see schematic on page 20 and detection cell on page 167], is isolated in instrument away from other sensors);
the analysis apparatus is configured to:
acquire an analysis error (analysis errors due to poor data are shown via the software [see red error message on page 137]) that is an abnormality in analysis of the component of the object-to-be-measured (poor data shows analysis failed [table on page 137]), in a case where an abnormality occurs in the analysis of the object-to-be-measured, based on the measurement value by the measurement unit (data is taken from the laser measurement unit during an electrophoresis run [data is poor quality data from electrophoresis run [table on page 137], which is taken via the laser detection [laser detection, page 20]),
wherein the electrophoresis apparatus is configured to measure a plurality of the objects to be measured (for example, 16 DNA standard samples are run simultaneously as seen in the spectral calibration on page 54 of ABI 3130xl),
the display is configured to display a plurality of well position displays for each of the plurality of the objects-to-be-measured (well positions for each run are shown in well display on top of page 54 and 129), indicating a position of each of a plurality of wells in which each of the plurality of objects-to-be-measured is placed (well position is displayed [page 129]), or display a plurality of gel image displays for each of the plurality of the objects-to-be-measured (gel electropherograms are displayed side-by-side showing separation of sample [see display readout on page 129]), indicating the analysis result of each of the plurality of the objects-to-be-measured (analysis results displayed in color [page 54, 129]).
ABI 3130xl is silent on the analysis apparatus is configured to:
acquire the apparatus error detected based on the detection signal from the abnormality detector, and in a case where at least one of the apparatus error or the analysis error is detected, the analysis apparatus is configured to display an abnormality detection indication that indicates types of the detected abnormalities so that the apparatus error and the analysis error are mutually identifiable, on the display, and
the analysis apparatus is configured to display the apparatus error and the analysis error in different modes in the abnormality detection indication,
the analysis apparatus is configured to display a correspondence in an identifiable manner and the display the device error and the analysis error in an identifiable manner, the correspondence being between each of the plurality of the well position displays displayed on the display or each of the plurality of gel image displays, and an error, the error including the apparatus error and the analysis error.
MultiNA teaches an electrophoresis system (title), and teaches analysis apparatus is configured to: acquire the apparatus error detected based on the detection signal from the abnormality detection unit (MultiNA control software provides error messages [Section 8.2 Error Messages, page 244]; for example, high voltage [where did the error occur, page 245]), and in a case where at least one of the apparatus error or the analysis error is detected, the analysis apparatus is configured to display an abnormality detection indication that indicates types of the detected abnormalities (error messages list the flag type, for example high voltage [where did the error occur, page 245]) so that the apparatus error and the analysis error are mutually identifiable (as the MultiNA gives various errors, such as fatal [page 246] or warnings [page 256], each type of error is mutually identifiable), on the display (errors are shown on the display, see for example warning [page 256]), and
the analysis apparatus is configured to display the apparatus error and the analysis error in different modes in the abnormality detection indication (apparatus errors can be displayed, for example, as fatal errors are shown with a red X [para. 246]; and reanalysis messages such as ladder validation failed, is given as an example analysis error [page 257]);
the analysis apparatus is configured to display a correspondence in an identifiable manner (correspondence can be, for example, a color within each well where red indicates an error [page 59]) and to display the apparatus error and the analysis error in an identifiable manner (as indicated above, apparatus errors and analysis errors can be identified with symbols, such as a red X, or by color in the well grid)..
ABI 3130xl and MultiNA are considered analogous art to the claimed inventions because they are in the same field of electrophoresis systems. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the analysis apparatus of ABI 3130xI so that the analysis apparatus is configured to: acquire the apparatus error detected based on the detection signal from the abnormality detection unit, and in a case where at least one of the apparatus error or the analysis error is detected, the analysis apparatus is configured to display an abnormality detection indication that indicates types of the detected abnormalities so that the apparatus error and the analysis error are mutually identifiable, on the display, and the analysis apparatus is configured to display the apparatus error and the analysis error in different modes in the abnormality detection indication, the analysis apparatus is configured to display a correspondence in an identifiable manner, and to display the apparatus error and the analysis error in an identifiable manner, as taught by MultiNA, as identifying errors allows for troubleshooting of electrophoresis instrument (MultiNA, page 245). In addition, it would be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to rearrange the correspondence being between each of the plurality of the well position displays displayed on the display or each of the plurality of gel image displays, and also to combine the apparatus error and the analysis error into an error, as rearranging the location of the correspondence on the well grid display and combining the error types on a display are design choices. Rearrangement of parts where both arrangements are known equivalents is a design choice that gives predicable results. 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) [see MPEP 2144.04 (VI)]. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143(I)(A)).
Regarding Claim 2, modified ABI 3130xl teaches the electrophoresis system according to claim 1; the limitation “the electrophoresis apparatus is configured to output an apparatus error signal indicating that the apparatus error is detected to the analysis apparatus” is a functional limitation. Apparatus claims cover what a device is, not what a device does [MPEP 2114(II)]. A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, as evidenced by ABI 3130xl Troubleshoot, for example, an error message “leak detected” appears on the monitor in the event of a leak within the capillary array (ABI 3130xl Troubleshoot, [page 56]). Thus, the electrophoresis apparatus is capable of performing the claimed function above;
ABI 3130xl teaches the analysis apparatus is configured to display the abnormality detection indication on the display, in at least one of a case where the apparatus error signal is acquired from the electrophoresis apparatus or a case where the analysis error is detected in the analysis of the component of the object-to-be-measured (for example, a red error message for analysis failed due to poor data quality is displayed on the monitor [page 137]).
Regarding Claim 4, modified ABI 3130xl teaches the electrophoresis system according to claim 1.
ABI 3130xl teaches wherein in a case where the apparatus error is detected, the analysis apparatus is configured to display, on the display, the abnormality detection indication with a different display mode depending on a degree of importance of the detected apparatus error (as an example, for analysis extraction results are color-coded based on the type of error, such as failed extraction {red} or a warning for extraction {yellow} [page 134]).
Regarding Claim 5, modified ABI 3130xl teaches the electrophoresis system according to claim 1.
ABI 3130xl teaches wherein in a case where at least one of the apparatus error or the analysis error is detected, the analysis apparatus is configured to display, on the display, the abnormality detection indication that allows identification of the type of abnormality, by at least one of color-coding or an icon image indication according to the type of the detected abnormality (as an example, for analysis extraction results are color-coded based on the type of error, such as failed extraction {red} or a warning for extraction {yellow} [page 134]).
Regarding Claim 6, modified ABI 3130xl teaches the electrophoresis system according to claim 1.
ABI 3130xl teaches in a case where at least one of the apparatus error or the analysis error is detected in any one of the plurality of objects-to-be-measured, the analysis apparatus is configured to display the abnormality detection indication so as to allow identification of the object-to-be-measured in which the abnormality is detected (for example, in the event of an analysis failure, a red color-coded message is displayed along with the capillary number indicating which sample failed analysis [page 136]).
Regarding Claim 7, modified ABI 3130xl teaches the electrophoresis system according to claim 6; the limitation “wherein the electrophoresis apparatus is configured to sequentially measure the plurality of objects-to-be-measured” is a functional recitation. Apparatus claims cover what a device is, not what a device does [MPEP 2114(II)]. A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, the ABI 3130xl can be set up for continuous operation in which multiple samples can be sequentially run over time (ABI 3130xl, [page 199]). Thus, the electrophoresis apparatus (ABI 3130xl) is capable of performing the claimed function above.
ABI 3130xl is silent on the analysis apparatus is configured to display, on the display, a standby indication indicating the object-to-be-measured that is waiting for measurement among the plurality of objects-to-be-measured.
MultiNa teaches a microchip electrophoresis system (title), and teaches an analysis apparatus is configured to display, on the display, a standby indication indicating the object-to-be-measured that is waiting for measurement among the plurality of objects-to-be-measured (as illustrated in the well plate displays on page 59, a well with a green color means the status of the sample in that well is ‘waiting’).
MultiNA and modified ABI 3130xl are considered analogous art to the claimed inventions because they are in the same field of electrophoresis systems. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the analysis apparatus of modified ABI 3130XI to be configured to display, on the display unit, a standby indication indicating the object-to-be-measured that is waiting for measurement among the plurality of objects-to-be-measured, as taught by MultiNA, a standby indicator allows the user to see which samples are upcoming in a run of numerous samples (MultiNA, page 59]).
Regarding Claim 8, modified ABI 3130xl teaches the electrophoresis system according to claim 6.
ABI 3130xl teaches wherein the analysis apparatus is configured to display, on the display, the well position display indicating a position of each of the plurality of wells in which each of the plurality of objects-to-be-measured is placed, and the gel image display indicating the analysis result of each of the plurality of the objects-to-be-measured (a well position display for each well along with a gel image may be displayed by the monitor [page 129]), and
display the abnormality detection indication that allows identification of the object-to-be-measured in which the abnormality is detected, in the well position display (as an example, failed spectral calibration DNA samples shows as failed in the well display [page 54]) and the gel image display displayed on the display (as evidenced by KB Basecaller on Figure 6, page 3, DNA peaks that fail peak quality, are marked in red; note that the Sequence Analysis Software with KB Basecaller is designed to be used with the ABI 3130/3130xl electrophoresis systems [Introduction, page 1]).
Regarding Claim 10, modified ABI 3130xl teaches the electrophoresis system according to claim 8.
ABI 3130xl teaches the analysis apparatus is configured to display the gel image display in which the respective analysis results of the plurality of objects-to-be-measured are displayed side by side, on the display (the ABI 3130xl can display multiple DNA sample can be viewed side-by-side, illustrated on page 128), and
make an arrangement order of the plurality of analysis results in the gel image changeable (electropherograms can be selected and deselected using the check boxes in the capillary viewer [page120]).
ABI 3130xl is silent on display the abnormality detection indication in each of the plurality of analysis results displayed side by side in the gel image display.
MultiNA teaches display the abnormality detection indication in each of the plurality of analysis results displayed side by side (as illustrated on page 59 in the well grid, red circles indicating abnormalities for samples can be displayed side-by-side). Although MultiNA does not explicitly teach the abnormality is displayed in the gel image, MutliNA does teach the plurality of analysis results for a gel image are displayed side-by-side (see Figure on page 63). In addition, each of the gels bands in the gel image have run number and can have associated color, similar to the well grid, providing information to the user on the sample run.
MultiNA and ABI 3130xl are considered analogous art to the claimed inventions because they are in the same field of electrophoresis systems. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the analysis apparatus of ABI 3130XI to be configured to display the abnormality detection indication in each of the plurality of analysis results displayed side by side in the gel image display in the way as the plurality of analysis results for a gel image are displayed side-by-side as taught by MultiNA, since it would alert the user to and error or a failed sample (MultiNA, page 59]). Note that although MultiNA does not explicitly show the abnormality is displayed in the gel image, MultiNA chooses as a design choice to show the abnormality displayed in the well grid instead on the same display [see figure on page 63]. Rearranging the abnormality indication to show on the gel image instead of the well grid would be obvious to one of ordinary skill in the art as way to alert the user of an error. Rearrangement of parts where both arrangements are known equivalents is a design choice that gives predicable results. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Regarding Claim 12, ABI 3130xl teaches an electrophoresis apparatus (3130/3130xl Genetic Analyzer [page 10]) comprising:
a measurer (laser detection unit to measure fluorescence [page 20]), a channel (capillary [page 20]) that measures an object-to-be-measured (object-to-be-measured is a sample, such as a sample of various DNA lengths [see Dye Set E sequencing standard sample as an example on page 60]) separated by electrophoresis in a channel including a separation channel for separating the object-to-be-measured (capillary is used as a separation channel for separating a sample to be measured [see electropherogram on page 129]), a channel (capillary [page 20]) including a separation channel;
an abnormality detector (EP Current Sensor, EP Voltage, and Oven Temperature Sensors [see Instrument Status pane, page 124]) configured to output a detection signal (as illustrated in instrument status chart on page 126, current is constantly measured throughout the run) for detecting an apparatus error that is an abnormality in the electrophoresis apparatus (current can be monitored in an electrophoresis run to see any errors in current or current leaks) , the abnormality detector provided separately from the measurer (detection cell block, which only includes the laser and capillary windows for measurement [see schematic on page 20 and detection cell on page 167], is isolated in instrument away from other sensors);
the electrophoresis apparatus is configured to:
acquire an analysis error (analysis errors due to poor data are shown via the software [see red error message on page 137]) that is an abnormality in analysis of the component of the object-to-be-measured (poor data shows analysis failed [table on page 137]), in a case where an abnormality occurs in the analysis of the object-to-be-measured, based on the measurement value by the measurer (data is taken from the laser measurement unit during an electrophoresis run [data is poor quality data from electrophoresis run [table on page 137], which is taken via the laser detection [laser detection, page 20]),
wherein the electrophoresis apparatus is configured to measure a plurality of the objects to be measured (for example, 16 DNA standard samples are run simultaneously as seen in the spectral calibration on page 54 of ABI 3130xl),
the display is configured to display a plurality of well position displays for each of the plurality of the objects-to-be-measured (well positions for each run are shown in well display on top of page 54 and 129), indicating a position of each of a plurality of wells in which each of the plurality of objects-to-be-measured is placed (well position is displayed [page 129]), or display a plurality of gel image displays for each of the plurality of the objects-to-be-measured (gel electropherograms are displayed side-by-side showing separation of sample [see display readout on page 129]), indicating the analysis result of each of the plurality of the objects-to-be-measured (analysis results displayed in color [page 54, 129]).
ABI 3130xl is silent on the electrophoresis apparatus is configured to:
acquire the apparatus error detected based on the detection signal from the abnormality detector, and in a case where at least one of the apparatus error or the analysis error is detected, the analysis apparatus is configured to display an abnormality detection indication that indicates types of the detected abnormalities so that the apparatus error and the analysis error are mutually identifiable, on the display, and
the analysis apparatus is configured to display the apparatus error and the analysis error in different modes in the abnormality detection indication,
the analysis apparatus is configured to display a correspondence in an identifiable manner and the display the device error and the analysis error in an identifiable manner, the correspondence being between each of the plurality of the well position displays displayed on the display or each of the plurality of gel image displays, and an error, the error including the apparatus error and the analysis error.
MultiNA teaches an electrophoresis system (title), and teaches analysis apparatus is configured to: acquire the apparatus error detected based on the detection signal from the abnormality detection unit (MultiNA control software provides error messages [Section 8.2 Error Messages, page 244]; for example, high voltage [where did the error occur, page 245]), and in a case where at least one of the apparatus error or the analysis error is detected, the analysis apparatus is configured to display an abnormality detection indication that indicates types of the detected abnormalities (error messages list the flag type, for example high voltage [where did the error occur, page 245]) so that the apparatus error and the analysis error are mutually identifiable (as the MultiNA gives various errors, such as fatal [page 246] or warnings [page 256]), on the display unit (errors are shown on the display, see for example warning [page 256]), and
the analysis apparatus is configured to display the apparatus error and the analysis error in different modes in the abnormality detection indication (apparatus errors can be displayed, for example, as fatal errors are shown with a red X [para. 246]; and reanalysis messages such as ladder validation failed, is given as an example analysis error [page 257]);
the analysis apparatus is configured to display a correspondence in an identifiable manner (correspondence can be, for example, a color within each well where red indicates an error [page 59]) and to display the apparatus error and the analysis error in an identifiable manner (as indicated above, apparatus errors and analysis errors can be identified with symbols, such as a red X, or by color in the well grid).
ABI 3130xl and MultiNA are considered analogous art to the claimed inventions because they are in the same field of electrophoresis systems. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the analysis apparatus of ABI 3130xI so that the analysis apparatus is configured to: acquire the apparatus error detected based on the detection signal from the abnormality detection unit, and in a case where at least one of the apparatus error or the analysis error is detected, the analysis apparatus is configured to display an abnormality detection indication that indicates types of the detected abnormalities so that the apparatus error and the analysis error are mutually identifiable, on the display, and the analysis apparatus is configured to display the apparatus error and the analysis error in different modes in the abnormality detection indication, the analysis apparatus is configured to display a correspondence in an identifiable manner and to display the apparatus error and the analysis error in an identifiable manner as taught by MultiNA, as identifying errors allows for troubleshooting of electrophoresis instrument (MultiNA, page 245). In addition, it would be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to rearrange the correspondence being between each of the plurality of the well position displays displayed on the display or each of the plurality of gel image displays, and also to combine the apparatus error and the analysis error into an error, as rearranging the location of the correspondence on the well grid display and combining the error types on a display are design choices by the user. Rearrangement of parts where both arrangements are known equivalents is a design choice that gives predicable results. 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) [see MPEP 2144.04 (VI)]. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143(I)(A)).
Regarding Claim 13, ABI 3130xl teaches an electrophoresis analysis method (a method of separating biological components, such as DNA fragments [page 59]) comprising: a step of analyzing a component of an object-to-be-measured separated by electrophoresis (object-to-be-measured is a biologic sample such as DNA [page 59]; as evidenced by KB Basecaller, separated DNA sample is analyzed to basecall a DNA sequence [KB Basecaller Introduction and illustrated in Figures 5 and 6]), based on a measurement value obtained by measuring the object-to-be-measured separated by electrophoresis in a channel including a separation channel for separating the object-to-be-measured (as evidenced by KB Basecaller, Figure 3, analysis is based on measurement signal of fluorescent DNA sample measured by ABI 3130xl instrument); and
a step of outputting a detection signal for detecting an apparatus error that is an abnormality in an electrophoresis apparatus that measures the object-to-be-measured separated by electrophoresis (as illustrated in instrument status chart on page 126, current, temperature, and voltage are constantly measured throughout the run);
a step of acquiring an analysis error (analysis errors due to poor data are shown via the software [see red error message on page 137]) that is an abnormality in analysis of the component of the object-to-be-measured (analysis errors due to poor data are shown via the software [see red error message on page 137]), in a case where an abnormality occurs in the analysis of the object-to-be-measured, based on the measurement value (data is taken from the laser measurement unit during an electrophoresis run [data is poor quality data from electrophoresis run [table on page 137], which is taken via the laser detection [laser detection, page 20]).
acquire an analysis error (analysis errors due to poor data are shown via the software [see red error message on page 137]) that is an abnormality in analysis of the component of the object-to-be-measured (poor data shows analysis failed [table on page 137]), in a case where an abnormality occurs in the analysis of the object-to-be-measured, based on the measurement value (data is taken from the laser measurement unit during an electrophoresis run [data is poor quality data from electrophoresis run [table on page 137], which is taken via the laser detection [laser detection, page 20]),
wherein the electrophoresis analysis method further comprises:
a step of measuring a plurality of the objects to be measured (for example, 16 DNA standard samples are run simultaneously as seen in the spectral calibration on page 54 of ABI 3130xl),
a step of displaying a plurality of well position displays for each of the plurality of the objects-to-be-measured (well positions for each run are shown in well display on top of page 54 and 129), indicating a position of each of a plurality of wells in which each of the plurality of objects-to-be-measured is placed (well position is displayed [page 129]), or display a plurality of gel image displays for each of the plurality of the objects-to-be-measured (gel electropherograms are displayed side-by-side showing separation of sample [see display readout on page 129]), indicating the analysis result of each of the plurality of the objects-to-be-measured (analysis results displayed in color [page 54, 129]).
ABI 3130xl is silent on:
a step of acquiring the apparatus error detected based on the detection signal;
a step of, in a case where at least one of the apparatus error or the analysis error is detected, the analysis apparatus is configured to display an abnormality detection indication that indicates types of the detected abnormalities so that the apparatus error and the analysis error are mutually identifiable, on the display, and
wherein the apparatus error and the analysis error in different modes in the abnormality detection indication;
the step of displaying the abnormality detection indication includes to display a correspondence in an identifiable manner and the display the device error and the analysis error in an identifiable manner, the correspondence being between each of the plurality of the well position displays displayed on the display or each of the plurality of gel image displays, and an error, the error including the apparatus error and the analysis error.
MultiNA teaches an electrophoresis system (title), and teaches a step of acquiring the apparatus error detected based on the detection signal (MultiNA control software provides error messages [Section 8.2 Error Messages, page 244]; for example high voltage [where did the error occur, page 245]), and a step of, in a case where at least one of the apparatus error or the analysis error is detected, the analysis apparatus is configured to display an abnormality detection indication that indicates types of the detected abnormalities (error messages list the flag type, for example high voltage [where did the error occur, page 245]) so that the apparatus error and the analysis error are mutually identifiable (as the MultiNA gives various errors, such as fatal [page 246] or warnings [page 256]), on the display (errors are shown on the display, see for example warning [parge 256]), wherein the apparatus error and the analysis error are displayed in different modes in the abnormality detection indication (apparatus errors can be displayed, for example, as fatal errors are shown with a red X [para. 246]; and reanalysis messages such as ladder validation failed, is given as an example analysis error [page 257]);
the step of displaying an abnormality detection indication on the display includes to display a correspondence in an identifiable manner (correspondence can be, for example, a color within each well where red indicates an error [page 59]) and to display the apparatus error and the analysis error in an identifiable manner (as indicated above, apparatus errors and analysis errors can be identified with symbols, such as a red X, or by color in the well grid).
ABI 3130xl and MultiNA are considered analogous art to the claimed inventions because they are in the same field of electrophoresis systems. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the electrophoresis analysis method of ABI 3130xI by providing a step of acquiring the apparatus error detected based on the detection signal; a step of, in a case where at least one of the apparatus error or the analysis error is detected, the analysis apparatus is configured to display an abnormality detection indication that indicates types of the detected abnormalities so that the apparatus error and the analysis error are mutually identifiable, on the display, and the analysis apparatus is configured to display the apparatus error and the analysis error in different modes in the abnormality detection indication, the step of displaying an abnormality detection indication on the display includes to display a correspondence in an identifiable manner, and to display the apparatus error and the analysis error in an identifiable manner, as taught by MultiNA, as identifying errors allows for troubleshooting of electrophoresis instrument (MultiNA, page 245). In addition, it would be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to rearrange the correspondence being between each of the plurality of the well position displays displayed on the display or each of the plurality of gel image displays, and also to combine the apparatus error and the analysis error into an error, as rearranging the location of the correspondence on the well grid display and combining the error types on a display are design choices by the user. Rearrangement of parts where both arrangements are known equivalents is a design choice that gives predicable results. 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) [see MPEP 2144.04 (VI)]. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143(I)(A)).
Claims 9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over ABI 3130xl and MultiNA, as applied to claim 8 above, and in view of ABI 3500 (Applied Biosystems 3500/3500xL Genetic Analyzer User Guide, 2010). KB Basecaller is used as an evidence reference for Claim 9.
Regarding Claim 9, modified ABI 3130xl teaches the electrophoresis system according to claim 8,
ABI 3130xl teaches the analysis apparatus is configured to display the abnormality detection indication in the gel image display (for example a red color-coded display on the electropherogram when a given peak has poor signal [evidenced by KB Basecaller, Figure 6 on page 3]) including a well number indicating a well of the plurality of wells in which the measured object-to-be-measured is placed (the capillary/array viewer that outputs the gel image along with the well position for the selected capillary [page 129]).
ABI 3130xl is silent on a measurement order number indicating an order of measurement.
ABI 3500 teaches a display process for a plurality of gel images from an electrophoretic run (abstract), and teaches an analysis apparatus configured to display a measurement order number indicating the order of measurement (as illustrated in Array view, the injection number is given by the numbers in the top left corner, three in the example [page 77]).
ABI 3130xl and ABI 3500 are considered analogous art to the claimed inventions because they are in the same field of electrophoresis systems. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the analysis apparatus of ABI 3130xl to output and display a measurement order number indicating the order of measurement, as taught by ABI 3500, as numbering each run allows for tracking of run/injection order (ABI 3500, page 77]).
Regarding Claim 11, modified ABI 3130xl teaches the electrophoresis system according to claim 8.
ABI 3130xl teaches further comprising:
an operation unit that receives an input operation (keyboard and mouse [page 10]), wherein
the analysis apparatus is configured to display, on the display, the well position indicating respective positions of the plurality of wells in a grid pattern so as to correspond to the plurality of wells arranged in a grid pattern (as illustrated on page 129, the plurality of wells are displayed on the monitor and in a grid pattern [page 129]), and display the abnormality detection indication when an abnormality is detected, for each of the plurality of wells arranged in a grid pattern in the well position display (for example, for a failed spectral calibration run, a failed well with be displayed in a different color [page 54]), and
is configured to select the analysis result of each of the plurality of objects-to-be-measured placed in the plurality of wells included in a predetermined area (user can select a well to view the detailed electropherogram [page 129]), based on the reception of a selection operation by the operation unit from among the plurality of wells arranged in a grid pattern in the well position display (user can select a well to view the detailed electropherogram [page 129]).
ABI 3130xl is silent on “a selection operation by the operation unit to surround the predetermined area from among the plurality of wells arranged in a grid pattern in the well position display”.
ABI 3500 teaches a selection operation by the operation unit to surround the predetermined area from among the plurality of wells arranged in a grid pattern (see step 2 in procedure on name samples, page 48; the user can drag and select multiple cells/wells at once).
ABI 3130xl and ABI 3500 are considered analogous art to the claimed inventions because they are in the same field of electrophoresis systems. It would be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the analysis apparatus of ABI 3130xl to allow a selection operation by the operation unit to surround the predetermined area from among the plurality of wells arranged in a grid pattern in the well position display, as taught by ABI 3500, as dragging and selecting provides an alternative method of selecting wells to display ([ABI 3500, page 48]).
Response to Arguments
Applicant's arguments, see Remarks pgs. 11-16, filed 06/09/2026, with respect to the 35 U.S.C 101 and 35 U.S.C 103 rejections and amended claims have been fully considered.
Applicant’s Argument #1:
Applicant argues on pages 11-14 in Remarks dated 06/09/2026 that the ABI 3130xL and MultiNA does not teach the amended limitation “display a correspondence in a identifiable manner and to display the device error and the analysis error in an identifiable manner, the correspondence being between each of the plurality of the well position displays displayed on the display or each of the plurality of the gel image displays, and an error, the error including the apparatus error and the analysis error”, as ABI 3130xl does not provide a mechanism to identify which specific well or gel image corresponds to which specific type of error and MultiNA only displays color of wells based on analysis status using color, MultiNA does not teach a correspondence between each individual well position/gel image and the specific error type such that the apparatus error and the analysis error are identifiable within the context of those specific displays.
Examiner’s Response #1:
Applicant’s arguments have been fully considered, but are not persuasive. As taught by MultiNA, errors can be indicated by color coding the well in each position for analysis errors (see display on page 59 of MultiNA). The display of MultiNA is also capable of displaying apparatus errors along with symbols (see for example, pages 245-246 of MultiNA). ABI 3130xl also teaches errors can be shown on a display (system status shows red for example when a capillary fails spectral calibration [page 127]; and an error box lists errors that have occurred in the current run [page 125]). As such, one of ordinary skill in the art can choose to display a correspondence in an identifiable manner, the correspondence being between each of the plurality of the well position displays displayed on the display or each of the plurality of the gel image displays, and an error, the error including the apparatus error and the analysis error, as this is a rearrangement and combination of error messages taught by combined MultiNA and ABI 3130xl and would be considered an equivalent design choice. Rearrangement of parts where both arrangements are known equivalents is a design choice that gives predicable results. 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) [see MPEP 2144.04 (VI)]. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143(I)(A)).
Applicant’s Argument #2:
Applicant argues on pages 14-16 in Remarks dated 06/09/206 that, for the 101 rejection, the claims are not directed to an abstract idea, as amended claims 1, 12, and 13 have been amended to recite an “abnormality detector configured to output a detection signal…provided separately from the measurer”, and notes that the claimed invention does not merely involve a human looking at data, but the coordination of hardware signals. In addition, even if the claims were found to recite an abstract idea, they are not directed to that idea because the elements are integrated into a practical application that provides a technical improvement. Applicant also cites MPEP 2106.04(d)(1) and USPTO Subject Matter Eligibility Example 47 and BASCOM Global Internet v. AT&T Mobility LLC to further support withdrawal of the 101 rejection.
Examiner’s Response #2:
Applicant’s arguments have been fully considered, but are not persuasive. Although Applicant has amended independent Claims 1, 12, and 13 to recite “abnormality detector configured to output a detection signal…provided separately from the measurer”, the abstract ideas of “in a case where at least one of the apparatus error or the analysis error is detected, the analysis apparatus is configured to display an abnormality detection indication that indicates types of the detected abnormalities so that the apparatus error and the analysis error are mutually identifiable” and “the analysis apparatus is configured to display a correspondence in an identifiable manner and to display the device error and the analysis error in an identifiable manner, the correspondence being between each of the plurality of the well position displays displayed on the display or each of the plurality of the gel image displays, and an error, the error including the apparatus error and the analysis error” is more like the alarm in Parker V. Flook, and the claims of the instant application are directed towards various ways of displaying the apparatus error and the analysis error. Section 2106.04(a)(2) of MPEP states: “Certain Methods of Organizing Human Activity, including managing relationships and legal obligations, advertising and marketing, managing human behavior, and collecting, analyzing, classifying, and storing data” is directed to an abstract idea. Thus, the 101 rejection is maintained.
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.
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/R.L.G./Examiner, Art Unit 1795
/LUAN V VAN/Supervisory Patent Examiner, Art Unit 1795
