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 .
Remarks
This office action fully acknowledges Applicant’s remarks and amendments filed on 02 July 2026.
Claims 1-6 are pending.
Claims 1, 3, and 5 are amended.
No claims are cancelled.
No claims are withdrawn.
No claims are newly added.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Niiyama et al. (JP 2014/134484 A), hereinafter “Niiyama”, in view of Nakasawa et al. (US 2015/0044096 A1), hereinafter “Nakasawa”.
Regarding Claim 1, Niiyama teaches an automatic analyzer comprising:
a reagent bottle installation unit 100 (Fig. 1) that comprises a nozzle 106 (Fig. 10), a nozzle drive (Given that Figs. 10 and 12 show the probe 107 (corresponding to the nozzle 106 given that both the nozzle and the stirrer pass through the opening 110: “When the dispensing mechanism 106 accesses the reagent container 101 on the reagent disk 102 or when the magnetic particle agitation mechanism 107 accesses the reagent container 101, the dispensing hole lid 300 does not become an obstacle, and smooth dispensing and stirring operations can be performed.”) being driven through the opening 110, the nozzle 106 must necessarily comprise a nozzle drive for effecting such movement.), a stopper 300 (Fig. 10), and a stopper drive (“When a load clockwise in the R direction in FIG. 4 is applied to the dispensing hole lid 300 by the arm 210 of the reagent container moving mechanism 105, the spring 304 contracts, and the dispensing hole 109 and the stirring hole 110 are blocked by the dispensing hole lid 300.”), wherein the reagent bottle installation unit 100 is configured to install a reagent bottle 101 containing a reagent used for analysis (Figs. 1 and 6, and [0016]: “The reagent disk 102 is a device for storing and storing a large number of reagent containers 101”); wherein:
the nozzle 106 provides a supply flow path that connects a location where the reagent is used and an inside of the reagent bottle 101 installed in the reagent bottle installation unit 102 to the reagent bottle 101 (Fig. 1 and [0028]: “The reagent dispensing mechanism 106 is a mechanism that sucks a predetermined amount of reagent from the reagent container 101 stored in the reagent container storage device 100 and discharges the reagent to the reaction container on the reaction container holder 111 in the horizontal and vertical directions.”);
the stopper 300 is disposed on a movement path of the nozzle 106 and configured to prevent the nozzle from being inserted into the reagent bottle 101 when in a first position (Fig. 10), and further to allow the muzzle to be inserted into the reagent bottle when in a second position (Fig. 12) (See also [0023]: “When a load clockwise in the R direction in FIG. 4 is applied to the dispensing hole lid 300 by the arm 210 of the reagent container moving mechanism 105, the spring 304 contracts, and the dispensing hole 109 and the stirring hole 110 are blocked by the dispensing hole lid 300. As a result, the outside air and the air in the reagent container storage device 100 can be blocked.” – Fig. 10 shows the stopper 300 as blocking a movement path of the nozzle, blocking it from insertion into the reagent bottle. -- “When the dispensing mechanism 106 accesses the reagent container 101 on the reagent disk 102 or when the magnetic particle agitation mechanism 107 accesses the reagent container 101, the dispensing hole lid 300 does not become an obstacle, and smooth dispensing and stirring operations can be performed.”),
the nozzle drive moves the nozzle on the movement path from above the stopper to a position in which the nozzle is inserted into the reagent bottle when the stopper is in the second position (Figs. 10 and 12: the hole lid 300 is actuated by the rotation base 201.), and
a control unit (Fig. 1: “control device 130”),
as in Claim 1.
Further regarding Claim 1, Niiyama does not specifically teach the automatic analyzer discussed above wherein the control unit is configured to control the stopper drive that drives the stopper by: determining, based at least in part on reagent information associated with the reagent bottle, whether the reagent bottle comprises a reagent bottle desired to be installed or a reagent bottle undesired to be installed; in response to determining that the reagent bottle comprises a reagent bottle undesired to be installed, controlling the stopper drive that drives the stopper to restrict a movement of the nozzle, wherein controlling the stopper drive that drives the stopper to restrict the movement of the nozzle comprises fastening the stopper at a lock position; and in response to determining that the reagent bottle comprises a reagent bottle desired to be installed, controlling the stopper drive that drives the stopper to forgo restricting the movement of the nozzle; and control the nozzle drive that moves the nozzle by fastening a reagent aspiration nozzle at a rise position, as in Claim 1.
However, Nakasawa teaches a respective automatic analyzer comprising an RFID reader that reads RFID information associated with reagent bottles/containers so as to determine if the reagent bottle is correct before performing further operations involving the reagent container ([0043]: “In step S520, the determination unit 20A confirms the reagent container information to be loaded from the reagent container information read by the RFID reader 32. Thereafter, in step S530, the drive control unit 20B controls the reagent container transport mechanism 17 to take out the target reagent container from the second reagent disk 16.”), wherein this arrangement reduces error related to an incorrect reagent container being installed.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the automatic analyzer of Niiyama wherein the control unit is configured to control the stopper drive that drives the stopper by: determining, based at least in part on reagent information associated with the reagent bottle, whether the reagent bottle comprises a reagent bottle desired to be installed or a reagent bottle undesired to be installed; in response to determining that the reagent bottle comprises a reagent bottle undesired to be installed, controlling the stopper drive that drives the stopper to restrict a movement of the nozzle, wherein controlling the stopper drive that drives the stopper to restrict the movement of the nozzle comprises fastening the stopper at a lock position; and in response to determining that the reagent bottle comprises a reagent bottle desired to be installed, controlling the stopper drive that drives the stopper to forgo restricting the movement of the nozzle, such as suggested by Nakasawa so as to reduce errors related to incorrect reagent use in assays requiring particular reagent.
Further as in Claim 1, Regarding the “lock position,” Niiyama [0022]–[0024] and Figures 3–6 show that arm 210 applies a load to lid 300 to move it across and close dispensing hole 109, thereby physically preventing the dispensing nozzle from entering the reagent container. More specifically, Niiyama [0029] expressly discloses that the closed lid remains closed while a constant load is applied, that the drive may employ either a motor that holds torque or a push-to-lock mechanism, and that reagent-container moving mechanism 105 is “locked” at its standby position so that lid 300 remains closed, even after power is turned off. Niiyama [0061] further discloses that control device 130 outputs a signal that moves mechanism 105 to the standby position, causes lid 300 to close the dispensing opening, maintains that condition, and locks movement at that position.
Thus, Niiyama expressly teaches fastening or retaining the stopper at a lock position. Therein, a skilled artisan providing the response-effective engaging of the reagent container of Nakasawa, in response to if the correct container has been inserted, would maintain the “lock position” of the stopper in Niiyama as the position is specifically held to prevent contamination.
Further as in Claim 1, regarding the “rise position,” Niiyama [0035] discloses that reagent dispensing mechanism 106 aspirates reagent from container 101 and includes a vertical movement mechanism. Niiyama [0020] identifies dispensing hole 109 as the opening through which dispensing mechanism 106 accesses the reagent container, while [0024] states that such access becomes possible only after lid 300 slides away from the opening. Niiyama’s operating sequence in [0043]–[0046] likewise opens lid 300 before dispensing, performs dispensing while the lid is open, and thereafter returns the system to the standby condition and closes the lid. Because lid 300 physically occupies and locks across the nozzle’s insertion path when closed, the vertically movable aspiration nozzle necessarily must be withdrawn and retained above the lid before the lid can close. That withdrawn upper position reads on the claimed “rise position.” The claim does not require a particular fastening structure, height, or type of latch for the nozzle. Accordingly, controlling the vertical drive to stop and retain the aspiration nozzle at its withdrawn position accounts for “fastening” the nozzle at the rise position.
At minimum, retaining the nozzle in that raised position would have been an obvious and necessary implementation of Niiyama’s disclosed sequence to prevent interference between the nozzle and the closing lid. Thus, a skilled artisan providing the response-effective engaging of the reagent container of Nakasawa, in response to if the correct container has been inserted, would maintain the “rise position” of the stopper in Niiyama as the position is specifically held to allow reagent aspiration.
Regarding Claim 2, the prior art meets the limitations of Claim 1 as discussed above. Further, as best understood by the claim, Niiyama teaches the automatic analyzer discussed above wherein the stopper is disposed on the movement path where a length from an upper end to a lower end of the nozzle is equal to a movement distance of the nozzle, when the nozzle moves from above the stopper to the position where the nozzle is inserted into the reagent bottle (Figs. 10 and 12 show the nozzle having an upper-end to lower-end length equal to the movement distance of the nozzle respective to the position of the stopper 300 which plugs the hole 110 through which the nozzle is inserted, thereby defining the upper and lower end lengths – see further para. [0010]. Further note, as discussed above, while the figures show stirring mechanism 107 as being inserted, the stirring mechanism merely represents an option of several probes as shown in Fig. 1, including the nozzle 106. – Further note that the amended recitation “when the nozzle moves from above the stopper to the position where the nozzle is inserted into the reagent bottle” converts the claim to a conditional process recitation not positively required by the claim and thereby not afforded patentable weight.), as in Claim 2.
Regarding Claim 3, the prior art meets the limitations of Claim 1 as discussed above. Further, Niiyama teaches the automatic analyzer discussed above wherein the control unit is further configured to control the stopper drive to fasten the stopper except for a timing at which the reagent bottle is replaced ([0038]: “the control device 130 closes the dispensing hole 109 and the agitation hole 110 with the dispensing hole lid 300 when the operator determines that the operator may leave the device for a long time or the device power-off state, and the reagent.”), as in Claim 3.
Regarding Claim 4, the prior art meets the limitations of Claim 3 as discussed above. Further, Niiyama does not specifically teach the automated analyzer discussed above further comprising: an RFID reader that reads the reagent information, wherein the reagent information is recorded on an RFID tag attached to the reagent bottle, as in Claim 4.
However, Nakasawa teaches a respective automatic analyzer comprising an RFID reader that reads RFID information associated with reagent bottles/containers so as to determine if the reagent bottle is correct before performing further operations involving the reagent container ([0043]: “In step S520, the determination unit 20A confirms the reagent container information to be loaded from the reagent container information read by the RFID reader 32. Thereafter, in step S530, the drive control unit 20B controls the reagent container transport mechanism 17 to take out the target reagent container from the second reagent disk 16.”), wherein this arrangement reduces error related to an incorrect reagent container being installed.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the automatic analyzer of Niiyama further comprising: an RFID reader that reads the reagent information, wherein the reagent information is recorded on an RFID tag attached to the reagent bottle, such as suggested by Nakasawa, so as to reduce error related to an incorrect reagent container being installed; and would have a reasonable expectation of success therein.
Regarding Claim 5, the prior art meets the limitations of Claim 1 as discussed above. Further, Niiyama teaches the automatic analyzer discussed above wherein the control unit is further configured to: control the nozzle drive that moves the nozzle to control the movement of the nozzle, wherein the control unit is further configured to control the nozzle drive that moves the nozzle to fasten the nozzle except for a timing at which the reagent bottle is replaced ([0036]: “The control device 130 creates an analysis plan based on a measurement request from the operator, and based on this plan, an initial preparation operation performed before the analysis process, a dispensing operation of each part, an analysis process of the detection result of the detection unit, etc. The operation of each mechanism of the automatic analyzer is controlled and analysis is performed.”), as in Claim 5.
Regarding Claim 6, the prior art meets the limitations of Claim 5 as discussed above. Further, Niiyama does not specifically teach the automated analyzer discussed above wherein the control unit is further configured to control the nozzle drive that moves the nozzle by: in response to determining that the reagent bottle comprises a reagent bottle desired to be installed, controlling the nozzle drive that moves the nozzle to remain at the position in which the nozzle is inserted into the reagent bottle; and in response to determining that the reagent bottle comprises a reagent bottle undesired to be installed, controlling the nozzle drive that moves the nozzle to move the nozzle to a position at which the nozzle is not inserted into the reagent bottle, as in Claim 6.
However, Nakasawa teaches a respective automatic analyzer comprising an RFID reader that reads RFID information associated with reagent bottles/containers so as to determine if the reagent bottle is correct before performing further operations involving the reagent container ([0043]: “In step S520, the determination unit 20A confirms the reagent container information to be loaded from the reagent container information read by the RFID reader 32. Thereafter, in step S530, the drive control unit 20B controls the reagent container transport mechanism 17 to take out the target reagent container from the second reagent disk 16.”), wherein this arrangement reduces error related to an incorrect reagent container being installed.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the device of Niiyama wherein the control unit is further configured to control the nozzle drive that moves the nozzle by: in response to determining that the reagent bottle comprises a reagent bottle desired to be installed, controlling the nozzle drive that moves the nozzle to remain at the position in which the nozzle is inserted into the reagent bottle; and in response to determining that the reagent bottle comprises a reagent bottle undesired to be installed, controlling the nozzle drive that moves the nozzle to move the nozzle to a position at which the nozzle is not inserted into the reagent bottle, such as suggested by Nakasawa, so as to reduce errors related to incorrect reagent use when an incorrect reagent container is installed.
Response to Arguments
35 USC 103
Applicant’s arguments are on the alleged grounds that Niiyama fails to disclose or suggest a control unit that, in response to identifying an undesired reagent bottle, restricts nozzle movement by “fastening the stopper at a lock position,” and that controls the nozzle drive by “fastening a reagent aspiration nozzle at a rise position.”
Applicant’s argument is not persuasive.
Regarding the “lock position”, Niiyama’s dispensing-hole lid 300 corresponds to the claimed stopper because it is positioned across dispensing hole 109, through which reagent dispensing mechanism 106 must pass to access reagent container 101. Niiyama [0022-0024] and Figs. 3-6 show that arm 210 applies a load to lid 300 to move it across and close dispensing hole 109, thereby physically preventing the dispensing nozzle from entering the reagent container. More specifically, Niiyama [0029] expressly discloses that the closed lid remains closed while a constant load is applied, that the drive may employ either a motor that holds torque or a push-to-lock mechanism, and that reagent-container moving mechanism 105 is “locked” at its standby position so that lid 300 remains closed, even after power is turned off. Niiyama [0061] further discloses that control device 130 outputs a signal that moves mechanism 105 to the standby position, causes lid 300 to close the dispensing opening, maintains that condition, and locks movement at that position. Thus, Niiyama expressly teaches fastening or retaining the stopper at a lock position; the newly added terminology merely describes Niiyama’s already-disclosed locked, nozzle-blocking position.
Regarding the “rise position”, Niiyama [0035] discloses that reagent dispensing mechanism 106 aspirates reagent from container 101 and includes a vertical movement mechanism. Niiyama [0020] identifies dispensing hole 109 as the opening through which dispensing mechanism 106 accesses the reagent container, while [0024] states that such access becomes possible only after lid 300 slides away from the opening. Niiyama’s operating sequence in [0043-0046] likewise opens lid 300 before dispensing, performs dispensing while the lid is open, and thereafter returns the system to the standby condition and closes the lid. Because lid 300 physically occupies and locks across the nozzle’s insertion path when closed, the vertically movable aspiration nozzle necessarily must be withdrawn and retained above the lid before the lid can close. That withdrawn upper position reasonably reads on the claimed “rise position.” The claim does not require a particular fastening structure, height, or type of latch for the nozzle. Accordingly, controlling the vertical drive to stop and retain the aspiration nozzle at its withdrawn position accounts for “fastening” the nozzle at the rise position. At minimum, retaining the nozzle in that raised position would have been an obvious and necessary implementation of Niiyama’s disclosed sequence to prevent interference between the nozzle and the closing lid.
Thus, in view of the above, Niiyama accounts for applicant’s amendmed “lock position” and “rise position”, these positions being implemented with the response-based control of Nakasawa such that they are engaged and disengaged as claimed in response to a correct/incorrect container being present. As such, Examiner maintains the rejection of Claims 1-6 as being unpatentable under 35 USC 103 over Niiyama in view of Nakasawa, the newly added portions above in the body of the rejection being necessitated by Applicant’s amendments.
Applicant’s arguments are further on the alleged grounds that Niiyama and Nakasawa, whether considered individually or in combination, fail to teach the complete information-dependent control recited in amended Claim 1 and therefore fail to establish a prima facie case of obviousness.
Applicant’s argument is not persuasive because it addresses Niiyama as though Niiyama alone were relied upon for the reagent-information determination. Niiyama supplies the physical stopper, locked stopper position, vertically driven aspiration nozzle, raised nozzle position, and control of those components. Nakasawa supplies the reagent-information determination and the resulting authorization or prevention of subsequent reagent operations. Thus, in the proposed combination, Nakasawa’s reagent-information determination controls whether Niiyama’s dispensing access is permitted. When the information identifies an undesired bottle, Niiyama’s lid 300 remains fastened in its locked, nozzle-blocking position and the aspiration nozzle remains fastened at its raised position. When the information identifies a desired bottle, the controller releases and moves lid 300 away from dispensing hole 109 and permits the nozzle to descend through the opening. This applies Nakasawa’s known accept/reject control criterion to Niiyama’s known physical access-control mechanism, predictably preventing an incorrect, expired, unusable, or otherwise undesired reagent from being accessed. The amendments therefore identify operating positions already taught or necessarily required by Niiyama and do not overcome the combination. Thus, Examiner maintains the rejection combining Niiyama and Nakasawa.
Applicant’s arguments are further on the alleged grounds that all claims depending from Claim 1 are allowable because independent Claim 1 is allegedly allowable.
Applicant’s argument is not persuasive because, as discussed above, Claim 1 and itd sependents are maintained as rejected under 35 USC 103 over Niiyama in view of Nakasawa. Applicant presents no separate substantive argument identifying error in the cited teachings or reasoning applied to the additional limitations of Claims 2–6. Because amended Claim 1 remains unpatentable over Niiyama in view of Nakasawa, and the rejection of record separately accounts for the additional limitations of the dependent claims, withdrawal of the rejections of claims 1–6 is not warranted.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798
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