Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim status
Claims 1-13 are pending.
Claims 1-7, and 9 have been amended.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
The term “the” should be inserted in the limitation to read as “wherein the plurality of displayed measurement timings” for consistency.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “wherein (the) plurality of displayed measurement timings include recognition of the rack in which the accuracy control sample is loaded, dispensing of the standard sample is complete, after analysis of the standard sample is started, and completion of measurement of the standard sample” on Pg. 2, lines 1-4.
However, support in applicant’s specification was not found for the following displayed measurement timings: 1) recognition of the rack in which the accuracy control sample is loaded; and 2) dispensing of the standard sample is complete.
Specifically, although the specification describes recognition of the rack (paras. [0070], [0072]-[0075]), support could not be found for displayed measurement time corresponding to recognition of the rack at a time in which the accuracy control sample is loaded (an amendment to the limitation is suggested to read as “recognition of the rack containing the accuracy control sample”)
Regarding when dispensing of the standard sample is complete, the specification (Para [0070]) and Fig. 5 describe the screen to select the measurement timing for the accuracy control sample but does not mention the displayed measurement timings are related to the standard sample. Although Fig. 2 describes the display for the standard sample, the specification does not support a displayed measurement timing specifically for when the dispensing of the standard sample is completed.
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Although Applicant refers to Fig. 5 which is a display of the measurement timings for the accuracy control sample, a displayed measurement timing related to recognition of the rack at a loading time of the accuracy control sample or when dispensing of the standard sample is complete, as recited in the claim, was not found in the specification.
Claims 2-13 are rejected as being dependent on independent claim 1.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 7, and 11-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nakamura et. al. (US 20080056944 A1).
Regarding Claim 1, Nakamura teaches “An automatic analyzer that analyzes a specimen, comprising:” (Para [0002], The present invention relates to an automated analyzer for the quantitative and qualitative analysis of biological samples.);
“an analysis unit that analyzes the specimen;” (Paras, [0025], [0027], and [0022], The analyzer modules 5, 6, 7 and 8). Although the analyzer modules 5, 6, 7 and 8 of this embodiment are biochemical analyzer modules, the automated analyzer may be provided with gene analyzer modules and immunity analyzer modules in combination with the analyzer modules.;
“a display;” (Para [0011], [0018] It is preferable that this automated analyzer includes an output device that displays. Display unit, 51, 61, 71 and 81.);
“a control unit, coupled to the display, programmed to: control operation of devices in the analyzer including the analysis unit,” (Paras, [0011], [0018], [0021], [0027], and [0028], The main control computer. The analyzer modules 5, 6, 7 and 8 are provided with analyzer module control computers 12, 13, 14 and 15, respectively. The analyzer module control computers 12, 13, 14 and 15 control processes to be carried out by the analyzer modules 5, 6, 7 and 8, respectively. It is preferable that this automated analyzer includes an output device that displays the name of the quality control material as a warning when it is expected that the amount of the quality control material is insufficient to prompt an operator to set a new quality control material. A display unit 19 for displaying results of analysis.)
“and, when an accuracy control sample is put in after input of a standard sample and upon recognizing a rack in which the accuracy control sample is loaded, automatically request measurement of the input accuracy control sample on the same measurement item as a measurement item requested for the standard sample” (Abstract and Paras [0011], [0045] – [0047], and [0005], In addition to In step 411, a sample rack holding a container containing the quality control material indicated at 502 stored in the buffer 91 is fed to the analyzer module 5 subsequently to feeding the rack holding the standard sample in step 408. In step 412, the biochemical values of the item name A of the standard sample and the quality control material supplied to the analyzer module 5 are measured. The measurement of the quality control material is performed immediately after the measurement of the standard sample for the reagent. The automated analyzer includes an input/output device for selecting either of an automatic measuring mode);
“receive a selection, via the display, selecting a measurement timing among a plurality of displayed measurement timings (Para [0011], It is preferable that this automated analyzer includes an output device that displays the name of the quality control material as a warning when it is expected that the amount of the quality control material is insufficient to prompt an operator to set a new quality control material.) for the automatic measurement of the accuracy control sample on the same item as the requested measurement item for the standard sample,” (Paras [0006], [0011], [0012], [0039] and [0049], An input/output device for selecting either of an automatic measuring mode and a manual measuring mode for the quality control measurement of a reagent when a request for a standard sample and the selection of a quality control material relevant to the reagent are executed.) measurement of the standard sample and the quality control material is needed at time after the passage of a set time. The automated analyzer of the present invention automatically executes the measurement of a reagent using a quality control material at proper time subsequently to the measurement of the reagent using a standard sample without requiring request from the operator. In step 402, "Request" is selected for an item indicated at 601 in FIG. 5 for requesting the measurement of the standard sample. When measurement is requested, a mark indicated at 602 is displayed and a mark indicated at 602 is displayed when measurement is not requested. "Request registration" indicated at 604 is depressed to complete setting selected items. If the manual quality control material measuring mode indicated at 504 is selected in step 407, the operator can request the measurement of the quality control material using the reagent at optional time to perform an analysis.)
Therefore the input/ output device (display) in the manual measuring mode can receive a selection of the request of the quality control material at optional time and this time is subsequent to the measurement of the standard sample as that happens first.
Also taught “automatically start measurement of the accuracy control sample when the selected timing is reached.” (Paras [0006], [0012] [0025], and [0040], Automatically executes the measurement of a reagent using a quality control material at proper time subsequently to the measurement of the reagent using a standard sample without requiring request from the operator. The operation in the manual quality control material measuring mode is performed when the operator requests it at an optional time. The measurement of the standard sample and the quality control material is needed not only for the periodical control of the accuracy of analysis, but also at time after the passage of a predetermined time since the unsealing of a reagent container, when reagents are changed and when a measurement of the reagent measured for quality control exceeds a predetermined value, from a standpoint of the accuracy control of the result of analysis. A buffer 91 is placed in the carrying line 3 or the rack recirculating line 4. The sample rack holding an assay sample can be stored for an optional time in the buffer 91. The sample rack is delivered from the buffer 91 at a desired time to the analysis module or the sample rack recovering unit 10. A sample rack holding quality control materials and standard samples which are to be analyzed at specified times can be stored in the buffer 91 and can be delivered to the analyzer modules at specified times.).
For purpose of examination, “wherein plurality of displayed measurement timings include recognition of the rack in which the accuracy control sample is loaded” will be interpreted as “recognition of the rack in which the standard sample is loaded”. is disclosed in Figs. 4 and 5 that shows the position which indicates the rack when the sample is loaded.
The recitation “dispensing of the standard sample is complete” is disclosed in Fig. 5 and Para [0040], shows how much was used which cannot be performed unless the analysis was complete.
The recitation “wherein plurality of displayed measurement timings include…after analysis of the standard sample is started, and completion of measurement of the standard sample.” (Para [0040] In step 403, either of an automatic quality control material measuring mode or a manual quality control material measuring mode shown in a radio box 504 is selected for the standard sample. The operation in the manual quality control material measuring mode is performed when the operator requests it at an optional time. If the automatic quality control material measuring mode is selected, the item name of the quality control material indicated at 501 to be tested by using the reagent for testing the standard sample requested and registered in step 402, the quality control material indicated at 502 and the amount used of the standard sample indicated at 503 are displayed. If the manual quality control material measuring mode is selected, manually selected items, the quality control material and the amount used of the quality control material are displayed. In FIG. 4, the automatic quality control material measuring mode is selected, the amount used of the quality control material is represented by the number of tests performed by way of example. In FIG. 4, the number of tests performed is twenty. When a print button indicated at 605 is depressed, the item, the quality control material and the amount used of the quality control material are printed by an output device.).
Therefore when the display shows how much was used for the test this indicates that analysis was started and is complete.
Regarding claim 2, Nakamura teaches all of claim 1 as above. In addition to “wherein the control unit is programmed to receive the selection selecting” (Para [0011] and taught above, Preferably, the automated analyzer includes an input/output device for selecting either of an automatic measuring mode and a manual measuring mode for the quality control measurement of a reagent when a request for a standard sample and the selection of a quality control material relevant to the reagent are executed. In addition to the control computer working with the input/output device.); “two or more of the measurement timings” (Para [0040] and Figs. 4 and 5, (Para [0040] the quality control material indicated at 502 and the amount used of the standard sample indicated at 503 are displayed.). Therefore when the display shows how much was used for the test this indicates that analysis was started and is complete which are measurement timings.
Regarding claim 7, Nakamura teaches all of claim 1 as above in addition to “wherein the control unit is programmed to automatically generate a request for measurement of the accuracy control sample for a reagent to which a measurement result of the standard sample is obtained based on a result of the standard sample measured with another reagent for measurement of the same measurement item.” (Abstract, A set standard sample is identified, and a quality control material relevant to a reagent requested by the standard sample and stored in a buffer is fed automatically to an analyzer module.).
Regarding claim 11, Nakamura teaches all of claim 1 as above in addition to teaching “comprising: a plurality of waiting areas in which the accuracy control sample is temporarily kept waiting, wherein the control unit is programmed to enable selection, via a screen on the display, as to in which waiting area among the plurality of waiting areas the accuracy control sample waits.” (Paras [0022], [0025] -[0029], and [0038-0039], The sample rack feed unit 1 feeds plural sample racks each holding plural assay samples. The sample rack feed unit 1 is provided with a computer 16 for controlling operations of the sample rack unit 1. The sample rack is delivered from the buffer 91 at a desired time to the analysis module or the sample rack recovering unit 10. A sample rack holding quality control materials and standard samples which are to be analyzed at specified times can be stored in the buffer 91 and can be delivered to the analyzer modules at specified times. Upon the transference of the sample rack from the sample rack feed unit to the carrying line 3, the ID reader unit 2 reads the sample ID information and the rack ID information and sends the same to the main control computer 11. Then, the main control computer 11 selects the analyzer modules for carrying out the specified analyses on the basis of the sample ID information and gives the information to the analyzer control computers included in the chosen analyzer modules among the analyzer computers 12, 13, 14 and 15. When each assay sample analyzed by each analyzer module is to be analyzed by another analyzer module, a sample rack storage unit 9 stores temporarily the sample rack holding the assay sample until a decision is made as to whether or not the assay sample is to be analyzed by another analyzer module after the analyzer module has completed dispensation and analysis. Connected also to the main control computer 11 are an operating unit 18 provided with an I/O device for entering necessary information. [0038] Information as shown in FIG. 4 about a quality control material stored in the buffer 91 is displayed in step 401. For example, in FIG. 4, indicated at 501 are reagents A, TSH and T4, and indicated at 502 are stored controls 1, 2 and 3 relevant to the reagent. In step 402, "Request" is selected for an item indicated at 601 in FIG. 5 for requesting the measurement of the standard sample. When measurement is requested, a mark indicated at 602 is displayed and a mark indicated at 602 is displayed when measurement is not requested. "Request registration" indicated at 604 is depressed to complete setting selected items.). Therefore the Input/ output device to enter information in which the operating unit and the main control computer are coupled to in addition to having the (plurality of waiting areas for the accuracy control sample) the plural sample racks within buffer or sample rack recovering unit along with the measurements being controlled at set time as taught above teach to this claim. In order for the accuracy control sample to be measured at set timing it needs to be placed someplace before or after which is controlled by the control computer.
Regarding Claim 12, Nakamura teaches all of claim 1 as above in addition to, “wherein the selection is made from an analyzer definition file or through communication from an external device or an external terminal.” (Para [0028], Connected also to the main control computer 11 are an operating unit 18 provided with an I/O device for entering necessary information, and a display unit 19 for displaying results of analysis.) The input/output device (I/O) device is the selection unit and where the selection is made this device is connected to the main controller and therefore an external device.
Regarding Claim 13, Nakamura teaches all of claim 1 as above in addition to, “wherein the selection is made by a registered parameter definition of the standard sample.” (Paras [0012] and [0040], Automatically executes the measurement of a reagent using a quality control material at proper time subsequently to the measurement of the reagent using a standard sample without requiring request from the operator. The operation in the manual quality control material measuring mode is performed when the operator requests it at an optional time.) The registered parameter definition of the standard sample is the proper time and that is what the selection is based off of.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 3, 4, 5, 6, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Nakamura et. al. (US 20080056944 A1) in view of Akutsu (US 20130039809 A1).
Regarding claim 3, Nakamura teaches all of claim 1 as above however does not explicitly teach “wherein the control unit is programmed to: determine whether the selected measurement timing is reached when the rack in which the accuracy control sample is loaded has been recognized”
Akutsu teaches an automatic analyzer for performing analysis of a precision control sample in response to external factors in addition to analysis of the accuracy control sample and the standard sample cannot be performed until they are both put into the instrument (Para [0010], If the operator does not input a rack mounting a calibrator and a precision control sample, calibration and precision control cannot be performed.) It would have been clearly within the ordinary skills of an artisan before the effective filing date of the claimed invention to have modified the invention of Nakamura to further include the teachings of Akutsu and to have further modified Akutsu by having the “wherein the control unit is programmed to: determine whether the selected measurement timing is reached when the rack in which the accuracy control sample is loaded has been recognized”. Nakamura already discloses the control unit starts measurement when timing has been reached and Akutsu further teaches the analysis cannot start till the accuracy control sample is put it. Therefore, it would have been a matter of an obvious engineering choice, to have the control unit programmed to determine whether the selected measurement timing is reached when the rack is which the accuracy control sample is loaded has been recognized. In order for the analysis to start the sample has to be present and having the presence recognized by the controller and having it start analysis (timing reached) would allow for no time gaps between analysis of samples which is an obvious improvement within an automatic analyzer. In addition, Nakamura teaches within Para [0012] The automated analyzer of the present invention automatically executes the measurement of a reagent using a quality control material at proper time subsequently to the measurement of the reagent using a standard sample without requiring request from the operator and Figs. 4 and 5 have the position of the rack showing it has been recognized.
If the control unit does not start automatic analysis of the accuracy control sample until the standard sample is complete it would be within obvious improvement to have the device determine the timing after the input of the accuracy control sample which is in the rack in order to not prematurely start the analysis of the accuracy control sample.
Nakamura further teaches “and determine whether the standard sample has a problem.” (Para [0012], Therefore, the appropriateness of the measurement of the standard sample can be verified).
Regarding Claim 4, modified Nakamura teaches all of claim 3 as above. In addition to “wherein the control unit is programmed to, upon determining that the measurement timing is reached and there is no problem with the standard sample, start measurement of the accuracy control sample immediately.” (Para [0012], What has already been taught above with respect to the control unit. The automated analyzer of the present invention automatically executes the measurement of a reagent using a quality control material at proper time subsequently to the measurement of the reagent using a standard sample without requiring request from the operator. Therefore, the appropriateness of the measurement of the standard sample can be verified, and highly reliable measurements can be guaranteed. Moreover, the insufficiency of the sample can be determined before analysis from the amount of the quality control material used for the automatic measurement of the quality control material and the operator can prepare and replenish the quality control material. Therefore, interruption or stoppage of measurement due to the insufficiency of the sample can be avoided and analysis can be continued.)
Regarding claim 5, modified Nakamura teaches all of claim 3 as above and therefore teaches to “wherein the control unit is programmed to, upon determining that the measurement timing is not reached, the accuracy control sample is kept at a current position until the selected timing is reached.” Taught within claim 3 is the determination of timing reached happens when the control sample is put in. Therefore if the timing is not reached during the determination (the accuracy control sample is not put in) it would be obvious that the accuracy control sample was waiting until the time was reached because within claim 3 that timing is when the accuracy control sample is put in and the measurement of the accuracy control sample happens automatically after the standard sample as taught within para [0012] of Nakamura.
In addition, Nakamura teaches the selection unit and the control unit do not start the analysis until any insufficiency’s of the sample can be determined (Para [0012], Moreover, the insufficiency of the sample can be determined before analysis from the amount of the quality control material used for the automatic measurement of the quality control material and the operator can prepare and replenish the quality control material. Therefore, interruption or stoppage of measurement due to the insufficiency of the sample can be avoided and analysis can be continued.) It would have been clearly within the ordinary skills of an artisan before the effective filing date of the claimed invention to have further modified the invention of Nakamura “wherein the control unit is programmed to, upon determining that the timing is not reached, the accuracy control sample is kept at a current position until the selected timing is reached.” If the accuracy control sample can be kept until insufficient are avoided it would be obvious engineering choice to have the sample kept until a correct time is met this would stop further analysis until all conditions were met and ensure no addition errors accorded.
Regarding claim 6, modified Nakamura teaches all of claim 3 as above in addition Nakamura teaches “wherein the control unit is programmed to, upon determining that the standard sample has a problem, regardless of whether the measurement timing is reached, stop analysis of the accuracy control sample” (Para [0012], Therefore, the appropriateness of the measurement of the standard sample can be verified, and highly reliable measurements can be guaranteed. Moreover, the insufficiency of the sample can be determined before analysis from the amount of the quality control material used for the automatic measurement of the quality control material and the operator can prepare and replenish the quality control material. Therefore, interruption or stoppage of measurement due to the insufficiency of the sample can be avoided and analysis can be continued.)
Regarding claim 8, modified Nakamura teaches all of claim 7 as above in addition to “wherein the control unit is programmed to enable a selection, via a screen display, as to whether to automatically generate a request for measurement of the accuracy control sample for the reagent to which the measurement result of the standard sample is inherited.” (Para [0011], The automated analyzer includes an input/output device for selecting either of an automatic measuring mode and a manual measuring mode for the quality control measurement of a reagent when a request for a standard sample and the selection of a quality control material relevant to the reagent are executed.) Therefore, the screen display is the input/output device and the control unit programed is taught above.
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Nakamura et. al. (US 20080056944 A1) as applied to claim 1 above, and further in view of Imai et. al (WO 2017038235 A1), machine translation.
Regarding claim 9, Nakamura teaches all of claim 1 as above but does not explicitly teach “wherein the control unit is programed to automatically generate a request for measurement of the accuracy control sample for a reagent to which a measurement result of the standard sample is obtained based on a measurement result of the standard sample for another measurement item with a same reagent”.
Nakamura teaches “wherein the control unit is programed to automatically generate a request for measurement of the accuracy control sample for a reagent to which a measurement result of the standard sample is” requested (Para [0010], The present invention provides an automated analyzer capable of automatically selecting a quality control material relevant to a reagent for testing a standard sample when the measurement of the standard sample for calibration is requested, of displaying at least the name of the reagent for the measurement of the quality control material and a necessary amount of the quality control material, of identifying a standard sample when the standard sample is supplied thereto, of executing the measurement of the selected quality control material immediately after the measurement of the identified standard sample.)
Nakamura does not teach “obtained based on a measurement result of the standard sample for another measurement item with a same reagent”.
Imai teaches an automatic analyzer for automatically analyzing a specific component contained in a biological sample such as serum or urine, and more particularly to a configuration for analyzing a plurality of components for one sample. In addition, Imai teaches “obtained based on a measurement result of the standard sample for another measurement item with a same reagent”. (Page 6, The calibration result of each analysis item (HIV-Ag_c and A-HIV_c) constituting the set item is copied from the individual calibration result (HIV-Ag and A-HIV) of each analysis item. This is because the calibration conditions such as the analysis reagent kit, calibration sample, and measurement conditions used for calibration are all equal for each analysis item constituting the set item and each individual analysis item.)
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 Nakamura to incorporate the teachings of Imai wherein a request for measurement of the accuracy control sample for a reagent to which a measurement result of the standard sample is obtained based on a measurement result of the standard sample for another measurement item with a same reagent is automatically requested. Nakamura teaches to having the accuracy control sample automatically analyzed after the standard sample is requested and measured. The coping of the standard sample (which is used for the calibration) would be that it is based on a measurement result of the standard sample for another measurement item with a same reagent is automatically requested and therefore the control unit would automatically analyze the accuracy control sample. Adding this modification would reduce time and effort for the user to perform unnecessary calibration work as taught in Imai and also not delay subsequent testing’s which would also reduce the time and effort for the user.
Regarding claim 10, modified Nakamura teaches all of claim 9 as above. In addition Nakamura further teaches “wherein the control unit is programmed to enable selection, via a screen on the display, as to whether to automatically generate a request for measurement of the accuracy control sample for the reagent to which the measurement result of the standard sample is copied.” (Para [0011], The automated analyzer includes an input/output device for selecting either of an automatic measuring mode and a manual measuring mode for the quality control measurement of a reagent when a request for a standard sample and the selection of a quality control material relevant to the reagent are executed.) As mentioned above, the request is the copy and above that the control computer programs and enables and works with the input/out device. The input/ output device determines whether or not the quality control material (accuracy control sample) is analyzed based on a request for (copy of) the standard sample.
Response to Arguments
Applicant's arguments filed 6/5/2026 have been fully considered.
Applicant argues that Nakamura does not disclose or suggest the ability to select the timing of measurement of the quality control sample for the same items as those requested for the standard sample.
Examiner maintains its taught within (Paras [0006], [0011], [0012], [0039], [0049], [0012], [0025], and [0040], selecting either of an automatic measuring mode and a manual measuring mode (receive a selection), input/output device (display), Measurement of the standard sample and the quality control material is needed at time after the passage of a set time (measurement timing), for the quality control measurement of a reagent when a request for a standard sample and the selection of a quality control material relevant to the reagent are executed (measurement timing…for the automatic measurement of the accuracy control sample on the same item as the requested measurement item for the standard sample).
Further (Para [0012] and [0040], Automatically executes the measurement of a reagent using a quality control material at proper time subsequently to the measurement of the reagent using a standard sample without requiring request from the operator. The operation in the manual quality control material measuring mode is performed when the operator requests it at an optional time. The operation in the manual quality control material measuring mode is performed when the operator requests it at an optional time.). Under broadest reasonable interpretation of the expression “measurement timings”, the examiner maintains that Nakamura meets the limitations as claimed. Measurement timing is being interpreted as any time in which a measurement takes place.
Applicant further argues that Nakamura does not disclose “receive a selection, via the display, selecting a measurement timing among a plurality of displayed measurement timings, for the automatic measurement of the accuracy control sample on the same item as the requested measurement item for the standard sample, and automatically start measurement of the accuracy control sample when the selected timing is reached, wherein plurality of displayed measurement timings include recognition of the rack in which the accuracy control sample is loaded, dispensing of the standard sample is complete, after analysis of the standard sample is started, and completion of measurement of the standard sample”. Further applicant states Akustu does not teach the stated deficiencies of Nakamura.
Examiner respectfully disagrees. The information shown in Nakamura’s Figs. 4 and 5corresponds to the claimed language of the displayed measurement timings of “recognition of the rack in which the accuracy control sample is loaded, dispensing of the standard sample is complete, after analysis of the standard sample is started, and completion of measurement of the standard sample” (see claim 1 rejection above).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VELVET E HERON whose telephone number is 571-272-1557. The examiner can normally be reached M-F 8:30am – 4:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached on (571) 270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/V.E.H./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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