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 .
Remarks
This Office Action fully acknowledges applicant’s remarks filed 05/11/2026. Claims 11-23 are pending. Claims 11-13 and 20 have been amended.
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 11, 13, 14, 16, 18, and 19 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.
Claim 11 recites “the control unit dispenses a corresponding standard solution with priority over the emergency sample” in the last line.
The dispensing mechanism dispenses samples (not the control unit).
For the purpose of examination, the limitation will be interpreted as “the control unit controls the dispensing mechanism to dispense a corresponding standard solution with priority over the emergency sample” for clarity and consistency with the specification.
Claims 13, 14, 16, 18, and 19 are rejected as being dependent on independent claim 11.
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.
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.
1. Claim 11, 13, 14, 16, 18 and 19 are rejected under 35 USC 103 as being unpatentable over Japanese Patent Application Publication No. H0835970 to Nishida et al. (cited by applicant)
Nishida et al. teaches an automatic analyzer that includes a disk-shaped sample holder 7 and a dispensing mechanism 4 shown in Fig. 1.
Nishida et al. teaches that the operation is controlled by a computer (“control unit”). [0007]
Nishida et al. teaches that the sample vessels contain multiple quality control samples, multiple standard sample and multiple emergency samples. (claim 1)
Nishida et al. teaches that the operator sets the measurement conditions involved in collecting samples from the sample containers and the mechanisms of the sample holding unit and the analysis and data processing which inherently involves prioritizing dispensing of the various samples based on user input, so that the computer control unit dispenses sample having a highest priority. [0007]. Note, Nishida et al. teaches providing samples on predetermined positions of the sample containers, which is interpreted as providing for locating different samples in desired locations before use. [0004]
Nishida et al. teaches that standard samples are dispensed at regular intervals. [0004].
Accordingly, standard samples would periodically be dispensed with priority over subsequent emergency samples. Further, since analysis of standard samples are used as a baseline for comparative purposes, it would otherwise be obvious to dispense and analyze standard samples before processing emergency samples for purposes of being able to evaluate analysis of emergency samples as compared to standard samples.
As to the newly added limitations that the control unit is configured to control based on the information on the priority and the information on the constraint condition, the operation of the sample disk and the dispensing mechanism, in Nishida et al. it would have been obvious for an operator to determine and select desired priorities and constraint conditions that determine how the dispensing mechanism is controlled by the computer to arrange a desired order of dispensing.
I.) Regarding applicant’s claim 11, as noted above Nishida et al. renders all the elements of claim 11 obvious.
Therefore, Nishida et al. renders claim 11 obvious.
II.) Regarding applicant’s claim 13, as noted above Nishida et al. renders claim 11 obvious from which claim 13 depends.
Claim 13 recites that the sample containers can be installed at any position on the sample disk regardless of the type of the samples.
As noted above, Nishida et al. teaches that samples can provided on predetermined positions on the sample disk which is interpreted as providing for locating different samples in desired locations before use.
It would have been obvious to one skilled in the art that since the positions of the samples are predetermined, samples can be installed at any position on the sample disk regardless of the type of the samples and their positions can be predetermined by the operator and computer controller.
Therefore, Nishida et al. renders claim 13 obvious.
III.) Regarding applicant’s claim 14, as noted above Nishida et al. renders claim 13 obvious from which claim 14 depends.
Claim 14 recites that the sample disk is provided with a region in which only the emergency sample can be installed.
As noted above, Nishida et al. teaches that samples can provided on predetermined positions on the sample disk which is interpreted as providing for locating different samples in desired locations before use.
It would have been obvious to one skilled in the art to provide emergency samples only in a desired predetermined location on the sample disk as a matter of choice.
Therefore, Nishida et al. renders claim 14 obvious.
IV.) Regarding applicant’s claim 16, as noted above Nishida et al. renders claim 11 obvious from which claim 16 depends.
Claim 16 recites a display unit configured to display the information stored in the storage unit, wherein the control unit causes the display unit to display an input screen on which an operator sets the priority.
As noted above, Nishida et al. provides for an operator to set the measurement conditions involved in collecting samples from the sample containers and the mechanisms of the sample holding unit and the analysis and data processing which inherently involves a means for the operator to input control instructions into the analysis system. Nishida et al. teaches a display screen [0015]. An input screen for an operator to input control conditions would have involved merely using a known manner of inputting control parameters.
It would have been obvious to provide Nishida et al. with a display unit configured to display the information stored in the storage unit, wherein the control unit causes the display unit to display an input screen on which an operator sets the priority for operator monitoring and control purposes.
Therefore, Nishida et al. renders claim 16 obvious.
V.) Regarding applicant’s claim 18, as noted above Nishida et al. renders claim 16 obvious from which claim 18 depends.
Claim 18 recites that the input screen allows the operator to input any priority.
As noted above, Nishida et al. provides for an operator to set the measurement conditions involved in collecting samples from the sample containers and the mechanisms of the sample holding unit and the analysis and data processing which inherently involves a means for the operator to input control instructions into the analysis system. Nishida et al. teaches a display screen [0015]. An input screen for an operator to input control conditions would have involved merely using a known manner of inputting control parameters.
It would have been obvious to provide Nishida et al. with an input screen that allows the operator to input any priority for control purposes.
Therefore, Nishida et al. renders claim 18 obvious.
VI.) Regarding applicant’s claim 19, as noted above Nishida et al. renders claim 16 obvious from which claim 19 depends.
Claim 19 recites that on the input screen, a combination of a predetermined couple of patterns of priorities is displayed, and one of the displayed patterns is selected.
Nishida et al. teaches a display screen [0015]. An input screen for an operator to input control conditions would have involved merely using a known manner of inputting control parameters.
Nishida et al. does not teach that on the input screen, a combination of a predetermined couple of patterns of priorities is displayed, and one of the displayed patterns is selected.
It would have obvious to modify Nishida et al. to display on an input screen, a combination of a predetermined couple of patterns of priorities for an operator to choose between for control purposes.
Therefore, Nishida et al. renders claim 19 obvious.
2. Claims 12, 17, 20, 21, 22, and 23 are rejected under 35 USC 103 as being unpatentable over Japanese Patent Application Publication No. H0835970 to Nishida et al.
Nishida et al. teaches an automatic analyzer that includes a disk-shaped sample holder 7 and a dispensing mechanism 4 shown in Fig. 1.
Nishida et al. teaches that the operation is controlled by a computer (“control unit”). [0007]
Nishida et al. teaches that the sample vessels contain multiple quality control samples, multiple standard sample and multiple emergency samples. (claim 1)
Nishida et al. teaches that the operator sets the measurement conditions involved in collecting samples from the sample containers and the mechanisms of the sample holding unit and the analysis and data processing which inherently involves prioritizing dispensing of the various samples based on user input, so that the computer control unit dispenses sample having a highest priority. [0007]. Note, Nishida et al. teaches providing samples on predetermined positions of the sample containers which is interpreted as providing for locating different samples in desired locations before use. [0004]
Nishida et al. teaches that standard samples are dispensed at regular intervals. [0004].
Nishida et al. does not teach that the control unit causes the display unit to display an input screen allowing selection of whether to allocate dispensing of both the standard solution and the quality control sample before the emergency sample or allocate only the standard solution when a priority of the emergency sample is set to be higher than that of the standard solution and the quality control sample.
As noted above, Nishida et al. teaches that the operator sets the measurement conditions involved in collecting samples from the sample containers and the mechanisms of the sample holding unit and the analysis and data processing which inherently involves prioritizing dispensing of the various samples based on user input, so that the computer control unit dispenses sample having a highest priority. Nishida et al. teaches a display screen [0015]. An input screen for an operator to input control conditions would have involved merely using a known manner of inputting control parameters.
It would have been obvious to one of ordinary skill in the art to modify Nishida et al. so that control unit causes the display unit to display an input screen allowing selection of whether to allocate dispensing of both the standard solution and the quality control sample before the emergency sample or allocate only the standard solution when a priority of the emergency sample is set to be higher than that of the standard solution and the quality control sample for purposes of allowing an operator to control dispensing of the samples.
As to the newly added limitations that the control unit is configured to control based on the information on the priority and the information on the constraint condition, the operation of the sample disk and the dispensing mechanism, in Nishida et al. it would have been obvious for an operator to determine and select desired priorities and constraint conditions that determine how the dispensing mechanism is controlled by the computer to arrange a desired order of dispensing.
I.) Regarding applicant’s claim 12, as noted above Nishida et al. renders all the elements of claim 12 obvious.
Therefore, Nishida et al. renders claim 12 obvious.
II.) Regarding applicant’s claim 17, as noted above Nishida et al renders claim 12 obvious from which claim 17 depends.
Claim 17 recites that the control unit causes the display unit to display an input screen on which an operator sets the priority.
As noted above, Nishida et al. teaches that the operator sets the measurement conditions involved in collecting samples from the sample containers and the mechanisms of the sample holding unit and the analysis and data processing which inherently involves prioritizing dispensing of the various samples based on user input, so that the computer control unit dispenses sample having a highest priority. Nishida et al. teaches a display screen [0015]. An input screen for an operator to input control conditions would have involved merely using a known manner of inputting control parameters.
It would have been obvious to one of ordinary skill in the art to have the control unit in Nishida et al. cause a display unit to display an input screen on which an operator sets the priority for purposes of control.
III.) Regarding applicant’s claim 20, as noted above Nishida et al renders claim 12 obvious from which claim 20 depends.
Claim 20 recites that the sample containers can be installed at any position on the sample disk regardless of the type of the samples.
As noted above, Nishida et al. teaches that samples can provided on predetermined positions on the sample disk which is interpreted as providing for locating different samples in desired locations before use.
It would have been obvious to one skilled in the art that since the positions of the samples are predetermined, samples can be installed at any position on the sample disk regardless of the type of the samples and their positions can be predetermined by the operator and computer controller.
Therefore, Nishida et al. renders claim 20 obvious.
IV.) Regarding applicant’s claim 21, as noted above Nishida et al renders claim 20 obvious from which claim 21 depends.
Claim 21 recites that the sample disk is provided with a region in which only the emergency sample can be installed.
As noted above, Nishida et al. teaches that samples can provided on predetermined positions on the sample disk which is interpreted as providing for locating different samples in desired locations before use.
It would have been obvious to one skilled in the art to provide emergency samples only in a desired predetermined location on the sample disk as a matter of choice.
Therefore, Nishida et al. renders claim 21 obvious.
V.) Regarding applicant’s claim 22, as noted above Nishida et al. renders claim 17 obvious from which claim 22 depends.
Claim 22 recites that the input screen allows the operator to input any priority.
As noted above, Nishida et al. provides for an operator to set the measurement conditions involved in collecting samples from the sample containers and the mechanisms of the sample holding unit and the analysis and data processing which inherently involves a means for the operator to input control instructions into the analysis system. Nishida et al. teaches a display screen [0015]. An input screen for an operator to input control conditions would have involved merely using a known manner of inputting control parameters.
It would have been obvious to provide Nishida et al. with an input screen that allows the operator to input any priority for control purposes.
Therefore, Nishida et al. renders claim 22 obvious.
VI.) Regarding applicant’s claim 23, as noted above Nishida et al renders claim 17 obvious from which claim 23 depends.
Claim 23 recites that on the input screen, a combination of a predetermined couple of patterns of priorities is displayed, and one of the displayed patterns is selected.
Nishida et al. teaches a display screen [0015]. An input screen for an operator to input control conditions would have involved merely using a known manner of inputting control parameters. Nishida et al. does not teach that on the input screen, a combination of a predetermined couple of patterns of priorities is displayed, and one of the displayed patterns is selected.
It would have obvious to modify Nishida et al. to display on an input screen, a combination of a predetermined couple of patterns of priorities for an operator to choose between for control purposes.
Therefore, Nishida et al. renders claim 23 obvious.
3. Claim 15 is rejected under 35 USC 103 as being unpatentable over Japanese Patent Application Publication No. H0835970 to Nishida et al.
Nishida et al. teaches an automatic analyzer that includes a disk-shaped sample holder 7 and a dispensing mechanism 4 shown in Fig. 1.
Nishida et al. teaches that the operation is controlled by a computer (“control unit”). [0007]
Nishida et al. teaches that the sample vessels contain multiple quality control samples, multiple standard sample and multiple emergency samples. (claim 1)
Nishida et al. teaches that the operator sets the measurement conditions involved in collecting samples from the sample containers and the mechanisms of the sample holding unit and the analysis and data processing which inherently involves prioritizing dispensing of the various samples based on user input, so that the computer control unit dispenses sample having a highest priority. [0007]. Note, Nishida et al. teaches providing samples on predetermined positions of the sample containers which is interpreted as providing for locating different samples in desired locations before use. [0004]
Nishida et al. teaches that standard samples are dispensed at regular intervals. [0004].
Nishida et al. does not teach that the control unit causes the display unit to display an input screen allowing selection of whether to allocate dispensing of both the standard solution and the quality control sample before the emergency sample or allocate only the standard solution when a priority of the emergency sample is set to be higher than that of the standard solution and the quality control sample.
As noted above, Nishida et al. teaches that the operator sets the measurement conditions involved in collecting samples from the sample containers and the mechanisms of the sample holding unit and the analysis and data processing which inherently involves prioritizing dispensing of the various samples based on user input, so that the computer control unit dispenses sample having a highest priority. Nishida et al. teaches a display screen [0015]. An input screen for an operator to input control conditions would have involved merely using a known manner of inputting control parameters.
It would have been obvious to one of ordinary skill in the art to modify Nishida et al. so that control unit causes the display unit to display an input screen allowing selection of whether to allocate dispensing of both the standard solution and the quality control sample before the emergency sample or allocate only the standard solution when a priority of the emergency sample is set to be higher than that of the standard solution and the quality control sample for purposes of allowing an operator to control dispensing of the solutions.
I.) Regarding applicant’s claim 15, as noted above Nishida et al. renders all the elements of claim 15 obvious.
Therefore, Nishida et al. renders claim 15 obvious.
Response to Arguments
Applicant's arguments filed 05/11/2026 have been fully considered but they are not persuasive.
On page 9 of applicant’s response applicant includes arguments that reference to the I, II and III modes which not claimed.
Applicant further argues that Office disregards the limitations regarding "information on the priority and the information on the constraint condition" in rejecting claim 11.
As noted above the constraint conditions and priorities are interpreted as operation inputs that an operator of Nishida et al. determines and selects for desired priorities and constraint conditions that determine how the dispensing mechanism is controlled by the computer to arrange a desired order of dispensing.
As for the control unit dispensing a corresponding standard solution with priority over an emergency sample, as noted above in Nishida et al., since analysis of standard samples are used as a baseline for comparative purposes, it would have been obvious to dispense and analyze standard samples before processing emergency samples for purposes of being able to evaluate analysis of emergency samples as compared to standard samples.
On page 12 of applicant’s response applicant argues that Nishida does not disclose "wherein the control unit is configured to control, based on the information on the priority and the information on the constraint condition wherein in the constraint condition, when a priority of the emergency sample is set to be higher than that of the standard solution in a setting of the priority and an item having no valid standard solution data is present among measurement items of the emergency sample, the control unit dispenses a corresponding standard solution with priority over the emergency sample.”
An operator inputting constraint conditions and priorities would cause the computer in Nishida et al. to operate and dispense as programmed – thereby functioning as a control unit. As noted above, an operator can select desired constraint conditions and priorities related to the order of dispensing in Nishida et al.
Conclusion
THIS ACTION IS MADE FINAL. 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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/M.S.G./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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