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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/20/2026 has been entered.
Status of Claims
Claim 12, 17-18, and 22 are pending and under examination.
Claims 1-11, 13-16, and 19-21 have been canceled.
Response to Amendment
Based on the amended claims, new claim objection(s) have been set forth.
Based on the amended claims and remarks received on 05/20/2026, the previous prior art rejection over Yasuaki has been withdrawn and a new prior art rejection is set forth (see below).
Claim Objections
Claim 12 is objected to because of the following informalities:
Claim 12 lines 5-6 recite “the first and second analysis modules and configured to conveying a specimen rack” which appears to be a grammatical/clerical mistake and should recite “the first and second analysis modules and configured to convey.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 12 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Yasuaki et al. (machine translation of JP 2010223810A; already of record – hereinafter “Yasuaki”) in view of Shibuya et al. (US Patent No. 7,842,237 – hereinafter “Shibuya”).
Regarding claim 12, Yasuaki disclose an automatic analysis device (Yasuaki; fig. 1, #1, [0032]) comprising:
first and second analysis modules for analyzing specimens (Yasuaki; fig. 1, #4a, #4b, [0032, 0034]);
a module (Yasuaki; fig. 1, #2, [0032]);
a display section rotatably mounted on the sampler module, the display section configured to display a first screen for displaying information of both the first and second analysis modules and being rotatable in a first direction to face toward one of the first and second analysis modules and in a second direction, opposite from the first direction, to face toward another one of the first and second analysis modules (Yasuaki disclose a display section 7 rotatably mounted to module 2, and displays information relating to reagent processing units 6a & 6b of the first and second analysis modules 4a and 4b when the display device 7 is rotated to a region corresponding to position B; figs. 1 & 8, [0039-0040, 0091, 0093, 0096]. With respect to the embodiment shown in figure 8, Yasuaki disclose a rotary encoder as the rotation detection sensor 18 which generates a pulse and detects when the support shaft 16 is rotated by a minute predetermined rotation angle; fig. 8, [0095], and the control 9 may be configured with a plurality of detection positions (P1, P2, P3, … Pn) having a plurality of memory units (9d1, 9d2, 9d3, … 9dn and 9e1, 9e2, 9e3, … 9en) which link a specific position (Dn1) of the sensor; fig. 5, [0063] to a designated function (9eb) and address (9ea) to stop displaying the first screen and to display a second screen; figs. 5-6, [0061, 0064-0065, 0068-0069]. Yasuaki also disclose “A rotation detection sensor 18 that detects the amount and direction of rotation of the support shaft 16 is provided at the lower end portion of the support shaft 16. For example, a rotary encoder is used as the rotation detection sensor 18 generates a pulse every time the support shaft 16 rotates by a minute predetermined rotation angle, and by integrating the number of pulses, detects the rotation amount of the support shaft and also detects the rotation direction.” See paragraph [0095]. Further, Yasuaki disclose in paragraph [0096] “The memory unit 9e and the database 9f can be the same as those in the first embodiment. The memory unit 9e and the database 9f are assigned to the divided areas of the rotation amount of the support shaft 16 detected by the rotation detection sensor 18.”. Accordingly, the rotation amount of the shaft 16 is detected by the sensor 18, and the display screen is switched between a plurality of screens based on the angle of rotation of the shaft 16);
a control section for controlling operations of the first and second analysis modules and the display section (Yasuaki; fig. 1, #9, [0060]); and
an angle detector for detecting an angle of the display section (Yasuaki; fig. 8, #18, [0095-0096]), wherein the control section is configured to cause the display section to:
stop displaying the first screen and display a second screen for displaying information when angle information detected by the angle detector indicates that the display section has been rotated in the first direction to face toward the one of the first and second analysis modules by a predetermined angle or more (Yasuaki disclose a display section 7 rotatably mounted to module 2, and displays information relating to the currently unmeasured sample when the display device 7 is rotated to a region corresponding to position A; figs. 1 & 8, [0039-0040, 0091, 0093, 0096]. With respect to the embodiment shown in figure 8, Yasuaki disclose a rotary encoder as the rotation detection sensor 18 which generates a pulse and detects when the support shaft 16 is rotated by a minute predetermined rotation angle; fig. 8, [0095], and the control 9 may be configured with a plurality of detection positions (P1, P2, P3, … Pn) having a plurality of memory units (9d1, 9d2, 9d3, … 9dn and 9e1, 9e2, 9e3, … 9en) which link a specific position (Dn1) of the sensor; fig. 5, [0063] to a designated function (9eb) and address (9ea) to stop displaying the first screen and to display a second screen; figs. 5-6, [0061, 0064-0065, 0068-0069]. Yasuaki also disclose “A rotation detection sensor 18 that detects the amount and direction of rotation of the support shaft 16 is provided at the lower end portion of the support shaft 16. For example, a rotary encoder is used as the rotation detection sensor 18 generates a pulse every time the support shaft 16 rotates by a minute predetermined rotation angle, and by integrating the number of pulses, detects the rotation amount of the support shaft and also detects the rotation direction.” See paragraph [0095]. Further, Yasuaki disclose in paragraph [0096] “The memory unit 9e and the database 9f can be the same as those in the first embodiment. The memory unit 9e and the database 9f are assigned to the divided areas of the rotation amount of the support shaft 16 detected by the rotation detection sensor 18.”. Accordingly, the rotation amount of the shaft 16 in the first direction would change the display to correspond to the currently unmeasured sample screen indicated by position A in figure 1); and
stop displaying the first screen and display a third screen for displaying information when angle information detected by the angle detector indicates that the display section has been rotated in the second direction to face toward the another one of the first and second analysis modules by the predetermined angle or more (Yasuaki disclose a display section 7 rotatably mounted to module 2, and displays information relating to the currently measured sample when the display device 7 is rotated to a region corresponding to position C; figs. 1 & 8, [0039-0040, 0091, 0093, 0096]. With respect to the embodiment shown in figure 8, Yasuaki disclose a rotary encoder as the rotation detection sensor 18 which generates a pulse and detects when the support shaft 16 is rotated by a minute predetermined rotation angle; fig. 8, [0095], and the control 9 may be configured with a plurality of detection positions (P1, P2, P3, … Pn) having a plurality of memory units (9d1, 9d2, 9d3, … 9dn and 9e1, 9e2, 9e3, … 9en) which link a specific position (Dn1) of the sensor; fig. 5, [0063] to a designated function (9eb) and address (9ea) to stop displaying the first screen and to display a second screen; figs. 5-6, [0061, 0064-0065, 0068-0069]. Yasuaki also disclose “A rotation detection sensor 18 that detects the amount and direction of rotation of the support shaft 16 is provided at the lower end portion of the support shaft 16. For example, a rotary encoder is used as the rotation detection sensor 18 generates a pulse every time the support shaft 16 rotates by a minute predetermined rotation angle, and by integrating the number of pulses, detects the rotation amount of the support shaft and also detects the rotation direction.” See paragraph [0095]. Further, Yasuaki disclose in paragraph [0096] “The memory unit 9e and the database 9f can be the same as those in the first embodiment. The memory unit 9e and the database 9f are assigned to the divided areas of the rotation amount of the support shaft 16 detected by the rotation detection sensor 18.”. Accordingly, the rotation amount of the shaft 16 in the second direction would change the display to correspond to the currently measured sample screen indicated by position C in figure 1).
Yasuaki does not explicitly teach displaying information of only the one of the first and second analysis modules in the first direction, or displaying information of only the another one of the first and second analysis modules in the second direction.
However, Yasuaki does teach a rotary encoder as the rotation detection sensor 18 which generates a pulse and detects when the support shaft 16 is rotated by a minute predetermined rotation angle; fig. 8, [0095], and the control 9 may be configured with a plurality of detection positions (P1, P2, P3, … Pn) having a plurality of memory units (9d1, 9d2, 9d3, … 9dn and 9e1, 9e2, 9e3, … 9en) which link a specific position (Dn1) of the sensor; fig. 5, [0063] to a designated function (9eb) and address (9ea) to stop displaying the first screen and to display a second screen; figs. 5-6, [0061, 0064, 0068-0069].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the controller configuration and memory units 9d/9e to link the second and third position with dedicated memory units comprising an address and function configured to display information of only the one of the first and second analysis modules when angle information detected by the angle detector indicates that the display section has been rotated in the first direction, and information of only the another one of the first and second analysis modules when angle information detected by the angle detector indicates that the display section has been rotated in the second direction, because linking the dedicated rotary position of the sensor 18 with dedicated memory units comprising an address and function configured to display information of only one or the other of the first and second analysis module would provide concise status information for an individual module, thereby allowing an operator to quickly obtain information and make decisions. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since Yasuaki teach setting defining additional positions (Pn) and memory areas (9pn, 9en) with the sensor and memory unit.
Modified Yasuaki does not teach the first analysis module performing a first type of inspection and the second analysis module performing a second type of inspection different from the first type of inspection or the module is a sampler module located between the first and second analysis modules and configured to conveying a specimen rack having one or more specimens to either one of the first and second analysis modules.
However, Shibuya teach the analogous art of an automatic analysis device (Shibuya; figs. 1 & 8, col. 2 lines 37-46 and col. 9 line 64 through col. 10 line 3), comprising first and second analysis modules for analyzing specimens (Shibuya; fig. 8, #2a, #2b, col. 9 line 64 through col. 10 line 3), the first analysis module performing a first type of inspection and the second analysis module performing a second type of inspection different from the first type of inspection (Shibuya; fig. 8, #2a, #2b, col. 11 lines 22-32), and a sample module located between the first and second analysis modules and configured to convey a specimen rack having one or more specimens to either one of the first and second analysis modules (Shibuya; fig. 8, #1, col. 2 line 60 through col. 3 line 5 and col. 10 lines 54-57).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the first and second analysis modules of Yasuaki to perform different inspections, and to modify the module of Yasuaki with the sampler module located between the first and second analysis modules, as taught by Shibuya, because Shibuya teach the different inspections allows a wider range of analysis to be performed on the samples and the sample module located between the first and second analysis modules reduces the transport time/length when transferring a rack to either one of the first and second analysis module for testing (Shibuya; col. 10 lines 54-57 and col. 11 lines 22-32). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Yasuaki and Shibuya both teach transporting sample racks containing specimens to multiple modules for analysis and testing in a clinical environment.
Regarding claim 22, modified Yasuaki teach the automatic analysis device according to claim 12 above, wherein the control section is configured to prevent transitioning from the first screen to the second screen or the third screen if the first screen is being used to perform system settings (Yasuaki; [0083-0088]).
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Yasuaki in view of Shibuya, and further in view of Naik (WO 2018213400 A1; hereinafter “Naik”; already of record) where US 2020/0192465 is used as the corresponding document.
Regarding claim 17, modified Yasuaki teach the automatic analysis device according to claim 12 above, wherein the control section is configured to cause the display section to display reagent information on the first screen the second screen and the third screen (The modification of the controller configuration and memory units 9d/9e to link the second and third position with dedicated memory units comprising an address and function configured to display information of only the one of the first and second analysis modules when angle information detected by the angle detector indicates that the display section has been rotated in the first direction, and information of only the another one of the first and second analysis modules when angle information detected by the angle detector indicates that the display section has been rotated in the second direction has previously been discussed in claim 12 above. Yasuaki additionally teach the control section configured to display reagent information stored in memory unit 9e that includes database 9f that stores reagent information used for creating various current status information screens; [0036, 0059, 0071, 0073]).
Modified Yasuaki does not explicitly teach the reagent information includes at least any one of reagent information among a remaining amount of a reagent required for analysis, a validity period of the reagent, and a target module using the reagent.
However, Naik teach the analogous art of an automatic analysis device (Naik; figs. 1-2) comprising: first and second analysis modules for analyzing specimens (Naik disclose a laboratory environment 14 comprising a multitube of diagnostic analyzer 16; figs. 1-2, #16, [0003, 0029]), a display section for displaying a first screen for displaying information of both the first and second analysis modules and being rotatable between the first and second analysis modules (Naik disclose image display device 34 for selectively generating a display of at least a portion of a captured optical image 20 on the display device 34 using an image capture device 18; [0029-0030]. A laboratory manager 42 is in communication with the multitude of diagnostic analyzers 16 for receiving status information 44 therefrom and for selectively directing an image processor 36 to embed a rendered graphical element 46 within the generated display 34 in response to the status information 44; fig. 2, #34 [0031]. The graphical element 46 is for communicating status information 44 regarding one or more of the plural diagnostics analyzers 16 within the laboratory environment 14 to a user 50 viewing the display 52 on the image display device 34; [0031]. Accordingly, a user may position the first and second diagnostic analyzer’s 16 in the field of view of the image capture device 18 to capture and display status information 44 on both diagnostic analyzer’s 16 (i.e. a first screen), or a user may rotate the field of view of the image capture device 18 to capture and display status information 44 on only the first diagnostic analyzer 16 or the second diagnostic analyzer 16; [0031]), and a control section for controlling operations of the first and second analysis modules and the display section (Naik disclose Atellica software which allows laboratory personnel to remotely control instruments and monitor testing progress and onboard inventory; [0027]), wherein the control section is configured to cause the display section to display at least any one of reagent information among a remaining amount of a reagent required for analysis, a validity period of the reagent, and target module using the reagent on the first screen and the second screen (Naik disclose a graphical status indicator 61 that shows a low reagent level associated with at least one of the multitude of diagnostic apparatus 16 of the laboratory environment 14; fig. 4, [0033]. The alphanumerical data is associated with at least one of the multitudes of diagnostic apparatus 16 of the laboratory environment 14; [0033]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the display section of modified Yasuaki to display at least any one of reagent information among a remaining amount of a reagent required for analysis, a validity period of the reagent, and a target module using the reagent, as taught by Naik, because Naik teach the display configured to display a remaining amount of a reagent required for analysis alerts the laboratory manager of a shortage (Naik; [0033]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Yasuaki and Naik both teach displaying reagent information for a plurality of analysis units.
Regarding claim 18, modified Yasuaki teach the automatic analysis device according to claim 12 above, wherein the control section displays information of the first and second analysis modules on the first screen, displays the information of only the one of the first and second analysis modules on the second screen, and displays the information including of only the another one of the first and second analysis modules on the third screen (Yasuaki teach the first screen for displaying information relating to reagent processing units 6a & 6b of the first and second analysis modules 4a and 4b when the display device 7 is at position B; [0039-0040]. Furthermore, the modification of the controller configuration and memory units 9d/9e to link the second and third position with dedicated memory units comprising an address and function configured to display information of only the one of the first and second analysis modules when angle information detected by the angle detector indicates that the display section has been rotated in the first direction, and information of only the another one of the first and second analysis modules when angle information detected by the angle detector indicates that the display section has been rotated in the second direction has previously been discussed in claim 12 above).
Modified Yasuaki does not teach the information is maintenance information including progress status of a maintenance.
However, Naik teach the analogous art of an automatic analysis device (Naik; figs. 1-2) comprising: first and second analysis modules for analyzing specimens (Naik disclose a laboratory environment 14 comprising a multitube of diagnostic analyzer 16; figs. 1-2, #16, [0003, 0029]), a display section for displaying a first screen for displaying information of both the first and second analysis modules and being rotatable between the first and second analysis modules (Naik disclose image display device 34 for selectively generating a display of at least a portion of a captured optical image 20 on the display device 34 using an image capture device 18; [0029-0030]. A laboratory manager 42 is in communication with the multitude of diagnostic analyzers 16 for receiving status information 44 therefrom and for selectively directing an image processor 36 to embed a rendered graphical element 46 within the generated display 34 in response to the status information 44; fig. 2, #34 [0031]. The graphical element 46 is for communicating status information 44 regarding one or more of the plural diagnostics analyzers 16 within the laboratory environment 14 to a user 50 viewing the display 52 on the image display device 34; [0031]. Accordingly, a user may position the first and second diagnostic analyzer’s 16 in the field of view of the image capture device 18 to capture and display status information 44 on both diagnostic analyzer’s 16 (i.e. a first screen), or a user may rotate the field of view of the image capture device 18 to capture and display status information 44 on only the first diagnostic analyzer 16 or the second diagnostic analyzer 16; [0031]), and a control section for controlling operations of the first and second analysis modules and the display section (Naik disclose Atellica software which allows laboratory personnel to remotely control instruments and monitor testing progress and onboard inventory; [0027]), wherein the control section displays maintenance information including progress status of a maintenance of the first and second analysis modules on the first screen and displays maintenance information including progress status of a maintenance of only the one of the first and second analysis modules on the second screen (Naik disclose the Atellica software tracks levels of onboard reagents and consumables, alerting operators of low-consumable levels in real-time; fig. 1, [0009]. The software also displays alphanumeric data 60 associated with at least one of the multitude of diagnostic apparatus 16 of the laboratory environment 14; [0033] including percentage of reagent remaining for at least one of the multitude of diagnostic apparatus 16; fig. 4, [0033]. The rendered graphical element 46 being responsive to selective direction (i.e. an angle of the display section) from the laboratory manager 42; [0032]. In response to selective direction from the laboratory manger 42, the rendered graphical element 46 will show status information on touch screen 62 of two or more analysis modules 16 in the laboratory environment 14 (fig. 1) or a single analysis module in the laboratory environment; figs. 2-4, [0033-0034]. Accordingly, a user may position the first and second diagnostic analyzer’s 16 in the field of view of the image capture device 18 to capture and display status information 44 on both diagnostic analyzer’s 16 (i.e. a first screen), or a user may rotate the field of view of the image capture device 18 to capture and display status information 44 on only the first diagnostic analyzer 16 or the second diagnostic analyzer 16 (i.e. a second screen and third screen); [0031]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the display section of modified Yasuaki to display maintenance information including progress status of a maintenance of the first and second analysis modules on the first screen and displays maintenance information including progress status of a maintenance of only the one of the first and second analysis modules on the second screen and third screen, as taught by Naik, because Naik teach the display configured to display maintenance information alerts the laboratory manager before a shortage occurs (Naik; [0033]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Yasuaki and Naik both teach displaying reagent information for a plurality of analysis units.
Response to Arguments
Applicant’s arguments filed on 05/20/2026 have been fully considered.
Applicant argues on pages 5-6 of their remarks towards the claim amendments and 103 rejection over Yasuaki in view of Pollack that the Yasuaki reference merely correspond to rotational position of arm 17 with the orientation of the display screen of display device 7 to indicate the location of the display screen as it moves from one analysis unit to another analysis unit. Applicant cites one sentence from paragraph [0095] of Yasuaki to support their argument. The examiner respectfully disagrees and asserts that applicant has mischaracterized the Yasuaki reference by using a single sentence as the basis for their argument to oversimplify the teachings and cited portions of the reference. Specifically, Yasuaki disclose a rotary encoder as the rotation detection sensor 18 which generates a pulse and detects when the support shaft 16 is rotated by a minute predetermined rotation angle; fig. 8, [0095], and the control 9 may be configured with a plurality of detection positions (P1, P2, P3, … Pn) having a plurality of memory units (9d1, 9d2, 9d3, … 9dn and 9e1, 9e2, 9e3, … 9en) which link a specific position (Dn1) of the sensor; fig. 5, [0063] to a designated function (9eb) and address (9ea) to stop displaying the first screen and to display a second screen; figs. 5-6, [0061, 0064-0065, 0068-0069]. With respect to the embodiment in figure 8, Yasuaki disclose “A rotation detection sensor 18 that detects the amount and direction of rotation of the support shaft 16 is provided at the lower end portion of the support shaft 16. For example, a rotary encoder is used as the rotation detection sensor 18 generates a pulse every time the support shaft 16 rotates by a minute predetermined rotation angle, and by integrating the number of pulses, detects the rotation amount of the support shaft and also detects the rotation direction.” See paragraph [0095]. Further, Yasuaki disclose in paragraph [0096] “The memory unit 9e and the database 9f can be the same as those in the first embodiment. The memory unit 9e and the database 9f are assigned to the divided areas of the rotation amount of the support shaft 16 detected by the rotation detection sensor 18.”. Accordingly, the rotation amount of the shaft 16 is detected by the sensor 18, and the display screen is switched between 3 screens corresponding to positions A, B, and C based on the angle of rotation of the shaft 16.
Regarding applicant’s argument towards the amended limitations on pages 7-8 of the remarks with respect to the sampler module as well as the different types of analysis modules, the examiner agrees that Yasuaki does not fully disclose each and every one of the amended limitations. Therefore, the previous prior art rejection has been withdrawn. However, upon further search and consideration, a new ground(s) of rejection is made over Yasuaki in view of Shibuya which the examiner asserts the combination of references teach the amended limitations of claim.
Citations to art
In the above citations to documents in the art, an effort has been made to specifically cite representative passages, however rejections are in reference to the entirety of each document relied upon. Other passages, not specifically cited, may apply as well.
Other References Cited
The prior art of made of record and not relied upon is considered pertinent to Applicant’s disclosure include:
Shibuya et al. (US 2021/0123935) disclose an automatic analyzer and display configured to display a reagent status detail screen for a plurality of analysis units.
Shibuya et al. (US 2020/0049724) disclose an automatic analyzer and display configured to display a reagent status detail screen for a plurality of analysis units.
Makino et al. (US 20200264201) disclose an automatic analyzer with a sampler module between a first and second analysis module.
Conclusion
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/C.A.T./Examiner, Art Unit 1798
/JOHN MCGUIRK/Examiner, Art Unit 1798
Prosecution Insights