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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-9 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 1 recites "a cleaning position" and "a first adjustment position" followed by reference to "the position". It is unclear which position is being referred to as the "position".
Claim 1 recites "a tip of the dispensing probe" twice. It is unclear if these are the same tips or different tips.
Claims 1, 4 and 9 recites “check results”, However, claims 1, 4 and 9 recite multiple “check” steps/adjustments and does not define anything as being a “result” of the check steps/adjustments. Therefore, it is unclear what “check results” are referring to.
Claims 1 and 9 recites "a position at which the horizontal distance from the cleaning nozzle is more distant than the first adjustment position" A distance is a measurement of length while a position is a point in space. Therefore, while the distance can be greater than another distance, it cannot be more distant than a position. As a result, it is unclear what the specific metes and bounds are of the positions and distances recited.
Claims 2 and 4 similarly to claims 1 and 9 recites a “distance” that is “more distant” and are unclear for the same reasons as claims 1 and 9.
The term “quasi-normal range” in claims 3 and 5 is a relative term which renders the claim indefinite. The term “quasi-normal range” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification describes “the liquid amount of probe cleaner is likely to be a minimum (quasi-normal) amount to the degree that the liquid barely contacts the tip of the sample dispensing probe 111b or is likely to be an excessive amount to the degree that the liquid contacts the sample dispensing probe 111b above beyond a predetermined height range”. However, the dictionary definition of quasi is “as if," "almost," or "resembling," used to indicate something that is similar to, but not exactly, the thing described. The specification appears to indicate “quasi” would be outside the desired and normal operating parameters whereas the general understanding of the term “quasi-normal” would be within or close to normal. Therefore, the metes and bounds of what is encompassed by “quasi-normal” are unclear.
Claims 2-8 are rejected as being dependent on an indefinite claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1 recites “the control unit determines a setting of the liquid amount adjustment means required to set a liquid amount of probe cleaner to the reference liquid amount based on check results”, this could be mental steps including judgment steps. The courts do not distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer (MPEP 2106.04(a)(2) section Ill). The limitations of “determine” as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitations in the mind. That is, nothing in the claim element precludes the steps from practically being performed in the mind. For example, but for the “control unit” language, “determine” in the context of this claim encompasses the user mentally judging how to set the liquid amount adjustment means based data collected from the detection means.
This judicial exception is not integrated into a particular practical application because once the judgment and/or decision is made nothing is done with the determination and therefore the abstract idea is not integrated into a particular practical application.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The claim recites an automated analyzer including controller for operating the probe cleaning, which are well understood, routine and conventional in automated analyzer operation, as discussed below. Claim 1 is therefore not patent eligible.
Claim 2 recites “the control unit ....determines the setting of the liquid amount adjustment means based on a movement amount from the first adjustment position”, this could be mental steps including judgment steps. The courts do not distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer (MPEP 2106.04(a)(2) section Ill). The limitations of “determine” as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitations in the mind. That is, nothing in the claim element precludes the steps from practically being performed in the mind. For example, but for the “control unit” language, “determine” in the context of this claim encompasses the user mentally judging how to set the liquid amount adjustment means based data collected from the detection means.
This judicial exception is not integrated into a particular practical application because once the judgment and/or decision is made nothing is done with the determination and therefore the abstract idea is not integrated into a particular practical application.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The claim recites an automated analyzer including controller for operating the probe cleaning, which are well understood, routine and conventional in automated analyzer operation, as discussed below. Claim 2 is therefore not patent eligible.
Claim 4 recites “the control unit determines the setting of the liquid amount adjustment means based on the determined degree of liquid contact”, this could be mental steps including judgment steps. The courts do not distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer (MPEP 2106.04(a)(2) section Ill). The limitations of “determine” as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitations in the mind. That is, nothing in the claim element precludes the steps from practically being performed in the mind. For example, but for the “control unit” language, “determine” in the context of this claim encompasses the user mentally judging how to set the liquid amount adjustment means based data collected from the detection means.
This judicial exception is not integrated into a particular practical application because once the judgment and/or decision is made nothing is done with the determination and therefore the abstract idea is not integrated into a particular practical application.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The claim recites an automated analyzer including controller for operating the probe cleaning, which are well understood, routine and conventional in automated analyzer operation, as discussed below. Claim 4 is therefore not patent eligible.
Claim 7 recites “the control unit checks whether the probe cleaner detection means has detected the liquid contact”, this could be mental steps including judgment steps. The courts do not distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer (MPEP 2106.04(a)(2) section Ill). The limitations of “check” as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitations in the mind. That is, nothing in the claim element precludes the steps from practically being performed in the mind. For example, but for the “control unit” language, “check” in the context of this claim encompasses the user mentally observing the data collecting from the probe cleaner detection means and deciding if the liquid has made contact.
This judicial exception is not integrated into a particular practical application because once the observation is made it is used to output an alarm based on the mental step(s), which amounts to “applying” the abstract idea generally without integrating it into a particular practical application. The courts have identified limitations that did not integrate a judicial exception into a particular practical application: Merely reciting the words "apply it" (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea, see MPEP 2106.04 (d) I. out putting a generic alarm is equivalent to merely applying the “judicial exception” and therefore does not integrate the judicial exception into a particular practical application.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The claim recites an automated analyzer including controller for operating the probe cleaning, which are well understood, routine and conventional in automated analyzer operation, as discussed below. Claim 7 is therefore not patent eligible.
Claim 9 recites “the control unit determines a setting of a liquid amount adjustment means required to set a liquid amount of probe cleaner to the reference liquid amount based on check results”, this could be mental steps including judgment steps. The courts do not distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer (MPEP 2106.04(a)(2) section Ill). The limitations of “determine” as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitations in the mind. That is, nothing in the claim element precludes the steps from practically being performed in the mind. For example, but for the “control unit” language, “determine” in the context of this claim encompasses the user mentally judging how to set the liquid amount adjustment means based data collected from the detection means.
This judicial exception is not integrated into a particular practical application because once the judgment and/or decision is made nothing is done with the determination and therefore the abstract idea is not integrated into a particular practical application.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The claim recites an automated analyzer including controller for operating the probe cleaning, which are well understood, routine and conventional in automated analyzer operation, as discussed below. Claim 9 is therefore not patent eligible.
The remaining claims further modify the abstract ideas discussed above, do no cure the issues of claims 1, 2, 4, 7 and 9 and/or recite well understood, routine and conventional features in the art of automated analyzer operation and therefore are not patent eligible for the same reasons above.
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.
Claim(s) 1-2 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Horie et al. WO 2021112120 (WO’120) (US 371 filing publication US2022/0299539 cited in the IDS filed 12-31-24 used for citation).
Regarding claim 1, WO’120 teaches an automated analyzer comprising: a dispensing mechanism including a dispensing probe that dispenses a sample or a reagent into a reaction container (automatic analyzer 100, a device that measures a reaction solution subjected to chemical reaction in a reaction container to analyze components, first sample dispensing mechanism 111 including sample dispensing probe 111b, dispenses a sample from the sample vessel 115 to the reaction container 102, para. 31-33, see fig. 1);
a cleaning nozzle configured to eject a probe cleaner to an outer surface of the dispensing probe (fluid discharge port 207/202 discharge the washing fluid such that liquid contact the outer surface of the sample dispensing probe 111b, para. 41-44 and 71-72, see fig. 2-5 and 9);
a liquid amount adjustment means configured to adjust a liquid amount of probe cleaner ejected from the cleaning nozzle (valve 209/2015 dispenses the washing fluid by adjusting the degree of opening, para. 41-44 and 71-73, see fig. 2 and 9);
a probe cleaner detection means provided in the dispensing mechanism and configured to detect a liquid contact to the dispensing probe (liquid level detecting device 210 and pressure sensor 204 that detects the pressure in the passage correspond to the same structure in applicant discloser as providing the probe cleaner detection means, para. 41, 53-55, 63-71, see fig. 2 and 9);
and a control unit configured to control the dispensing mechanism, the liquid amount adjustment means, and the probe cleaner detection means (controller 118, constituted of a computer and connected to the mechanisms to control the operations thereof, para. 38-40 and 82-83, see fig. 1 and 12), wherein,
during cleaning of the dispensing probe, the control unit ejects a reference liquid amount of probe cleaner from the cleaning nozzle in a state where a tip of the dispensing probe is at a cleaning position (washing position 301, the horizontal position of the sample dispensing probe 111b at the time of washing at which discharge is performed in a reference solution amount, para. 75-82, see fig. 10), and wherein,
in a case where a first adjustment position is a position at which a horizontal distance from the cleaning nozzle is more distant than the cleaning position, which is lower than the cleaning position, and at which the probe cleaner detection means detects the liquid contact during ejection of the reference liquid amount of probe cleaner from the cleaning nozzle when a tip of the dispensing probe is at the position (liquid amount confirming position 302, positioned on the downstream side to the washing nozzle 202 and desirably away from the washing position 301 at a horizontal distance five times the diameter of the washing nozzle 202 or more, at which the control unit lowers the sample dispensing probe 111b at a place away from the discharge port of the washing nozzle 202, the probe descending distance from a reference position to detection of the washing fluid top end is larger at the liquid amount confirming position 302 than at the washing position 301, para. 75-78, see fig. 10-11),
in the adjustment of the liquid amount of probe cleaner, after the control unit ejects the probe cleaner from the cleaning nozzle to check whether the probe cleaner detection means has detected the liquid contact in a state where the tip of the dispensing probe is at the first adjustment position (S608 to S613, the washing position 301 is moved to the liquid amount confirming position 302, the solenoid valve is opened to start the discharge of the washing fluid, and the dispensing probe is lowered until the liquid level detection signal is detected and the detection height B is recorded in the liquid current detection amount table 511, para. 89, see fig. 7,10 and 13),
the control unit ejects the probe cleaner from the cleaning nozzle to check whether the probe cleaner detection means has detected the liquid contact in a state where the tip of the dispensing probe is at a different position (the liquid amount confirming position 302 may be provided at two places or more, whereby a further confirming position at a greater horizontal distance from the washing nozzle 202 is provided. S621 to S626, the solenoid valve 217 is opened to start the discharge of the washing fluid and the dispensing probe is lowered until the liquid level detection signal is detected and the descending height of the dispensing probe is recorded, para. 76 and 92, see fig. 10 and 14), and
the control unit determines a setting of the liquid amount adjustment means required to set a liquid amount of probe cleaner to the reference liquid amount based on check results (liquid amount detection and adjustment control unit 507, determines the necessity of controlling the proportional valve 215 or the control amount based on information stored in the liquid current detection amount table 511. S622 - S629, the electric current manipulated variable is extracted from the proportional valve control table 513 and the difference between the recorded height B and the design value is calculated and the steps are repeated until the difference is a certain value or less, para. 83-96, see fig. 12, 14 and 16).
WO’120 does not teach the different position is above the first adjustment position or a position at which the horizontal distance from the cleaning nozzle is more distant than the first adjustment position.
However, WO’120 teaches that the sample dispensing mechanism moves the sample dispensing probe 111b by means of a sample dispensing arm 111c, a horizontal displacement mechanism 111d that moves the arm in the horizontal direction, and a perpendicular displacement mechanism 111e that moves the arm in the vertical direction, such that the probe tip is repositionable only along a vertical axis and a horizontal axis relative to the washing nozzle 202 (para. 69, see fig. 8). WO’120 further teaches that the liquid amount confirming position 302 may be provided at two places or more, and that the washing fluid current discharged from the washing nozzle 202 describes a parabola whose top end position exhibits a small change near the nozzle and a large change at a place away from the nozzle, so that detection at the position away from the washing nozzle 202 more easily reveals a change in the wash water amount and improves detection sensitivity (para. 76-78, see fig. 10 and fig. 11). Given a probe movable along only two axes, a second check position selected from the first adjustment position is limited to four directions, up, down, toward the washing nozzle, and away from the washing nozzle, of which the down and toward directions have already been established as wetted at the first adjustment position and therefore return the same detection result, leaving the up and away directions as the only two directions capable of yielding additional information regarding the top end position of the washing fluid current. Performing the ejection and detection operation at such a second position bounds the top end position of the washing fluid current between a position at which liquid contact is detected and a position at which liquid contact is not detected, which permits the liquid amount to be resolved with the improved detection sensitivity that WO’120 attributes to the downstream position (para. 77, see fig. 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of WO’120 to include the different position is above the first adjustment position or a position at which the horizontal distance from the cleaning nozzle is more distant than the first adjustment position because WO’120 teaches four possible directions for the additional testing positions and that the top end of the washing current can be sampled by movements up and away from the washing nozzle and choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success is obvious, see MPEP 2141 III (E).
Regarding claim 2, the modified apparatus of WO’120 teaches the automated analyzer according to claim 1. WO’120 further teaches wherein, in the adjustment of the liquid amount of probe cleaner, the control unit moves the tip of the dispensing probe toward an upper side (the dispensing probe is moved along the vertical direction at the liquid amount confirming position 302 by the perpendicular displacement mechanism 111e while the solenoid valve 217 is opened to discharge the washing fluid, and after the descending operation of the dispensing probe is finished an operation of raising the dispensing probe and returning the dispensing probe to the original position is inserted, para. 84-89, see fig. 8 and 13) until the probe cleaner detection means does detect the liquid contact (liquid level detecting device 210, the descending operation of the dispensing probe is performed until the liquid level detection signal is detected and the detection height of the liquid current of the washing fluid current is recorded as height in the liquid current detection amount table 511, para. 89, see fig. 13), and determines the setting of the liquid amount adjustment means based on a movement amount from the first adjustment position (the probe descending distance from a reference position to detection of a washing fluid top end constitutes the recorded movement amount, and where the difference between the recorded value of the height B and the design value is large it is determined that the adjustment of the liquid amount is necessary, para. 22, 78 and 90, see fig. 11 and fig. 13).
WO’120 does not teaches the tip moves until the detection means does not detect the liquid contact.
However, WO’120 further teaches that the operation of locating the top end position of the washing fluid current at the liquid amount confirming position 302 consists of moving the dispensing probe along the vertical direction while the washing fluid is discharged, and terminating the movement at the boundary at which the state of the liquid level detecting device 210 changes, the traversed distance being recorded as the movement amount used for the subsequent determination (para. 78-90, see fig. 11-13). The movement sequence at the liquid amount confirming position 302 comprises both a descending operation and a raising operation returning the dispensing probe to its original position, so that both directions of travel across the top end position of the washing fluid current are performed in the disclosed confirming operation (para. 84-91, see fig. 13-14). Since the boundary located is the same top end position of the washing fluid current and the distance traversed between the first adjustment position and that boundary is the same distance and provides the same positional data regardless of which end of the segment the movement begins from, selecting to perform the steps as detection to not detection instead of not detection to detection would provide the same positional data and would be an obvious selection of any order of performing steps.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified apparatus of WO’120 to include the tip moves until the detection means does not detect the liquid contact because WO’120 teaches acquiring the positional data based on a change of detection and selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results, see MPEP 2144.04 .IV. (C).
Regarding claim 8, the modified apparatus of WO’120 teaches the automated analyzer according to claim 1. WO’120 further teaches wherein, in the adjustment of the liquid amount of probe cleaner (the confirming operation of the washing fluid amount and the liquid amount adjustment operation by the proportional valve 215, performed in the reset or maintenance operation in which the liquid amount confirming position 302 is used, para. 80-84, see fig. 13 and 14), a speed at which the tip of the dispensing probe moves to a position above from the first adjustment position (dispensing arm vertical displacement unit 505, moves the sample dispensing arm 111c carrying the sample dispensing probe 111b in the vertical direction and is switched between a high speed movement and a low speed movement according to the operating mode by a normal washing mode and liquid amount detection and adjustment mode switching unit 508, such that the movement of the tip in the vertical direction during the adjustment of the washing fluid amount is performed at the low speed irrespective of the direction of travel, para. 81-82, see fig. 8 and 12; the confirming operation at the liquid amount confirming position 302 includes, after the descending operation of the dispensing probe is finished, an operation of raising the dispensing probe from the detection position and returning the dispensing probe to the original position, whereby the tip is moved to a position above the position at which the liquid level detection signal was detected, para. 84-91, see fig. 13 and 14) is slower than a speed at which the tip of the dispensing probe moves during the cleaning of the dispensing probe (at the time of confirming the liquid amount of the washing fluid the control unit slows the speed at which the sample dispensing probe 111b is lowered slower than the speed at which the sample dispensing probe 111b is lowered at the time of washing, para. 79, see fig. 10. Since high speed processing has to be performed at the time of analysis the dispensing arm vertical displacement unit 505 switches the speed such that high speed movement is performed at the time of analysis and low speed movement is performed at the time of adjusting the washing fluid amount, para. 82. see fig. 12; the descending speed of the dispensing probe at the liquid amount confirming position 302 is more slowed than the descending speed of the dispensing probe in the washing operation at the time of analysis, para. 89, see fig. 13).
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over WO’120 as applied to claim 2 above, and further in view of Mishima et al. US 2011/0171069 (US’069) and Murata et al. JP 2018194301 (JP’301) (machine translation used for citations).
Regarding claim 3, the modified apparatus of WO’120 teaches the automated analyzer according to claim 2.
The modified apparatus of WO’120 does not teach when the movement amount is within in a quasi-normal range, the control unit causes the liquid amount adjustment means to increase the liquid amount of probe cleaner, wherein, when the movement amount is within a normal range larger than the quasi-normal range, the control unit does not change the liquid amount of probe cleaner, and wherein, when the movement amount is within an excessive range larger than the normal range, the control unit decreases the liquid amount of probe cleaner.
US’069 teaches an automatic analyzer having a dispensing nozzle 1 that includes a liquid level detection function that detects contact with a liquid level, a cleaning nozzle 2 that discharges a cleaning liquid flow 3, and an automatic flow selector valve 4 disposed on a cleaning liquid pipeline whose degree of opening is controlled to increase or narrow the flow rate of the discharged cleaning liquid (para. 44-45 and 48, see fig. 6 and fig. 7). US'069 further teaches an executed initialization sequence that moves the dispensing nozzle along the horizontal and vertical axes until the liquid level of the cleaning liquid flow 3 is detected and memorizes the resulting liquid level detection positions 11, 12, and 14. and that further repeats an inching motion of the dispensing nozzle in the minus z direction until the nozzle distal end has become exposed from the cleaning liquid flow and memorizes the detection position 15 at which the distal end became exposed, whereby the executed sequence acquires and stores movement amounts of the nozzle measured to the boundary of the cleaning liquid flow (para. 48-49, see fig. 7). The start of the initialization operation following completion of apparatus power-on the dispensing nozzle moves to the position established by that sequence, and that if the liquid level is not detectible the dispensing nozzle remains in a stopped condition and the automatic flow selector valve 4 is opened to increase the flow rare and keep the path of the cleaning liquid flow 3 constant until the nozzle has detected the liquid level, thereby providing a disclosed program branch that conditions an increase in the discharged liquid amount on the outcome returned at a stored position and that terminates upon detection. The amount of cleaning liquid which adheres to the nozzle can be reduced by maintaining an optimal exit position (para. 53, see fig. 6 and 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified apparatus of WO’120 to include when the movement amount is within in a quasi-normal range, the control unit causes the liquid amount adjustment means to increase the liquid amount of probe cleaner because US’069 teaches it achieves the optimal flow of washing fluid and combining prior art elements according to known methods to yield predictable results is obvious, see MPEP 2141 III (A).
The modified apparatus of WO’120 does not teach wherein, when the movement amount is within a normal range larger than the quasi-normal range, the control unit does not change the liquid amount of probe cleaner, and wherein, when the movement amount is within an excessive range larger than the normal range, the control unit decreases the liquid amount of probe cleaner.
JP'301 teaches automatic analyzer is a device for measuring components related to test items such as biochemical test items and immunological test items. The control circuit 8 executes the system control function 81 and lowers the tip of the sample dispensing probe 205 from the initial position of the vertical movement until the cleaning liquid level is detected (step SA3). The first descent amount is calculated based on the number of drive pulses that are started from the position and come into contact with the cleaning liquid stored in the cleaning pool (step SA4) the control circuit 8 compares the calculated difference value of the descent amount with a threshold value D2 that is smaller than the preset threshold values D1 and D1, so that the amount of the cleaning liquid supplied to the cleaning pool 208 is a predetermined value (page 11). The program compares that movement amount against a preset threshold DI and a preset threshold D2 smaller than D1 and executes and adjusts the opening degree of the electromagnetic valve 288 where the movement amount exceeds the threshold D1 or smaller than threshold D2 or terminates the routine without changing the liquid amount where the movement amount is not less than the threshold D2 and not more than the threshold D1 (page 10-12). By automatically adjusting the cleaning liquid amount performance degradation from deterioration over time of the pump, single failure, or flow path clogging, can be compensated for (page 2 and 12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified apparatus of WO’120 to include wherein, when the movement amount is within a normal range larger than the quasi-normal range, the control unit does not change the liquid amount of probe cleaner, and wherein, when the movement amount is within an excessive range larger than the normal range, the control unit decreases the liquid amount of probe cleaner because JP’301 teaches By automatically adjusting the cleaning liquid amount performance degradation from deterioration over time of the pump, single failure, or flow path clogging, can be compensated for and combining prior art elements according to known methods to yield predictable results is obvious, see MPEP 2141 III (A).
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over WO’120 as applied to claim 1 above, and further in view of Mishima et al. US 2011/0171069 (US’069).
Regarding claim 6, the modified apparatus of WO’120 teaches the automated analyzer according to claim 1.
The modified apparatus of WO’120 does not teach wherein, when the probe cleaner detection means does not detect the liquid contact at the first adjustment position, the control unit causes the liquid amount adjustment means to increase the liquid amount of probe cleaner until the probe cleaner detection means detects the liquid contact.
US'069 teaches an automatic analyzer having a dispensing nozzle I that includes a liquid level detection function that detects contact with a liquid level, a cleaning nozzle 2 that discharges a cleaning liquid flow 3, and an automatic flow selector valve 4 disposed on a cleaning liquid pipeline that controls the flow rate of the discharged cleaning liquid (para. 44-48, see fig. 6 and fig. 7). US'069 further teaches an executed initialization sequence commencing when the automatic analyzer is powered on, in which the dispensing nozzle I moves in the x-direction until it has detected the liquid level of the cleaning liquid flow 3 and memorizes the liquid level detection position 11, thereafter moves in the minus x-direction until it has detected a current liquid level and memorizes the liquid level detection position 12, and thereafter moves to a position on a perpendicular bisector of the detection positions 11 and 12 and moves in the minus z direction until it has detected a particular liquid level of the cleaning liquid flow 3 and memorizes the liquid level detection position 14, the position 14 thereby being a defined position established by the executed sequence and stored for use in subsequent operation (para. 48, see fig. 7). US'069 further teaches that upon the start of the initialization operation following completion of apparatus power-on the dispensing nozzle I moves to the position 14 established by the dispensing nozzle position control operation, and that if the liquid level is not detectible the dispensing nozzle I remains in a stopped condition and the automatic flow selector valve 4 on the cleaning liquid pipeline is opened to increase the flow rate and keep the path of the cleaning liquid flow 3 constant until the nozzle has detected the liquid level, thereby providing a disclosed program branch that conditions an increase in the discharged liquid amount on a non-detection outcome returned at a defined stored position and that terminates upon detection of the liquid level. The amount of cleaning liquid which adheres to the nozzle can be reduced by maintaining an optimal exit position (para. 53, see fig. 6 and 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified apparatus of WO’120 to include wherein, when the probe cleaner detection means does not detect the liquid contact at the first adjustment position, the control unit causes the liquid amount adjustment means to increase the liquid amount of probe cleaner until the probe cleaner detection means detects the liquid contact because US’069 teaches it achieves the optimal flow of washing fluid and combining prior art elements according to known methods to yield predictable results is obvious, see MPEP 2141 III (A).
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.
Claim(s) 9 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Horie et al. WO 2021112120 (WO’120) (US 371 filing publication US2022/0299539 used for citation).
Regarding claim 9, WO’120 teaches a method of adjusting a liquid amount of probe cleaner of an automated analyzer that includes a dispensing probe that dispenses a sample or a reagent (automatic analyzer 100, a device that measures a reaction solution subjected to chemical reaction in a reaction container to analyze components, first sample dispensing mechanism 111 including sample dispensing probe 111b, dispenses a sample from the sample vessel 115 to the reaction container 102, para. 31-33, see fig. 1);
a cleaning nozzle that ejects a probe cleaner to an outer surface of the dispensing probe (fluid discharge port 207/202 discharge the washing fluid such that liquid contact the outer surface of the sample dispensing probe 111b, para. 41-44 and 71-72, see fig. 2-5 and 9),
a probe cleaner detection means for detecting a liquid contact to the dispensing probe (liquid level detecting device 210 and pressure sensor 204 that detects the pressure in the passage correspond to the same structure in applicant discloser as providing the probe cleaner detection means, para. 41, 53-55, 63-71, see fig. 2 and 9), and
a control unit that cleans the dispensing probe by ejecting a reference liquid amount of probe cleaner from the cleaning nozzle in a state where a tip of the dispensing probe is at a cleaning position (controller 118, constituted of a computer and connected to the mechanisms to control the operations thereof, para. 38-40 and 82-83, see fig. 1 and 12, washing position 301, the dispensing probe is moved thereto with an instruction from the probe washing control unit 506 to perform the washing process and the opening operation of the solenoid valve starts the discharge of the washing fluid at that position, the discharge is performed in a reference solution amount, para. 75-86, see fig. 10-13),
the method comprising: in a case where a first adjustment position is a position at which a horizontal distance from the cleaning nozzle is more distant than the cleaning position, which is lower than the cleaning position, and at which the probe cleaner detection means detects the liquid contact during ejection of the reference liquid amount of probe cleaner from the cleaning nozzle when the tip of the dispensing probe is at the position (liquid amount confirming position 302, to which the dispensing probe is moved from the washing position 301 during the confirming operation and at which the sample dispensing probe 111b is lowered at a place away from the discharge port of the washing nozzle 202 on the downstream side thereof, the liquid level detection signal being detected there while the washing fluid is discharged. The disclosed process necessarily produces a detection point at the liquid amount confirming position 302 lying below the detection point at the washing position 301, because the liquid current discharged from the washing nozzle 202 describes a parabola due to gravity and the probe descending distance from the reference position to detection of the washing fluid top end is accordingly larger at the liquid amount confirming position 302 than at the washing position 301, which is a result of gravity acting on the discharged stream, para. 76-89, see fig. 10-13),
a step in which the control unit ejects the probe cleaner from the cleaning nozzle to check whether the probe cleaner detection means has detected the liquid contact in a state where the tip of the dispensing probe is at the first adjustment position (Steps S608 to S613 are performed, in which the washing position 301 is moved to the liquid amount confirming position 302, the opening operation of the solenoid valve starts the discharge of the washing fluid, the dispensing probe is lowered until the liquid level detection signal is detected, the detection height B is recorded in the liquid current detection amount table 511, para.89-92, see fig. 13 and 14);
a step in which the control unit ejects the probe cleaner from the cleaning nozzle to check whether the probe cleaner detection means has detected the liquid contact in a state where the tip of the dispensing probe is at a position above the first adjustment position or a position at which the horizontal distance from the cleaning nozzle is more distant than the first adjustment position (as discussed above, the detection is made as position 301 and 302, having different horizontal distances, para. 89-95, see fig. 10, 13 and 15, the examiner notes that the recites steps are not required to be performed in any particular order); and
a step in which the control unit determines a setting of a liquid amount adjustment means required to set a liquid amount of probe cleaner to the reference liquid amount based on check results (liquid amount detection and adjustment control unit 507, determines the necessity of controlling the proportional valve 215 or the control amount based on information stored in the liquid current detection amount table 511. S622 - S629, the electric current manipulated variable is extracted from the proportional valve control table 513 and the difference between the recorded height B and the design value is calculated and the steps are repeated until the difference is a certain value or less, para. 83-96, see fig. 12, 14 and 16).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN FLANAGAN BERGNER whose telephone number is (571)270-1133. The examiner can normally be reached M-F 8:00-5:00.
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/ERIN F BERGNER/Primary Examiner, Art Unit 1713
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