DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/04/2025 has been entered.
Remarks
This office action fully acknowledges Applicant’s remarks and amendments filed on 04 November 2025.
Claims 1 and 3-9 are pending.
Claim 2 is cancelled.
No claims are withdrawn.
No claims are newly added.
Claims 1, 4, and 6-7 are amended.
Claim Interpretation
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitation(s) is/are:
“a sample dispensing mechanism configured to move the probe” as in Claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Those structures provided as seen through pars.[0016,0017,0049,0060] and figs. 1,5A-B, 6 of Applicant’s pre-grant publication US2023/009785, and equivalents thereof.
Further, the recited “sample dispensing mechanism that includes the probe and is configured to move the probe” is construed as those structure found in the cited disclosure above, wherein it is also seen that the probe itself provides the inferred “dispensing” functionality as such probe is recited as “performs suction and discharge…” and wherein the “sample dispensing mechanism…configured to move the probe” is the movable element that affords the probe to perform suction/discharge at different locations.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
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 and 2-9 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.
Further regarding Claim 1, the claim recites in relevant part: “a controller configured with the probe, the cleaning nozzle and the sample dispensing mechanism to start a first discharge of the cleaning water from the cleaning nozzle when a tip end of the probe is at a first height position, which is below a bottom edge of a flow of the cleaning water from the cleaning nozzle, and start a second discharge of the cleaning water from the cleaning nozzle when the tip end of the probe is at a second height position above the first height position, such that the tip end of the probe is arranged within the flow of the cleaning water from the cleaning nozzle”.
Therein, the “a first height position” and the “a second height position” are indefinitely defined given that the controller is not provided with a means for identifying/sensing and/or confirming that the particular first/second height has been met such that the selective action of starting the flow of cleaning water may be controllably initiated therewith.
Applicant provides the first/second height positions relative to a prospective flow of cleaning water which would not behave in the simplified manner as in Applicant’s instant Fig. 3 such that one skilled in the art would be able to understand the metes and bounds of the claim. Applicant may wish to provide a sensor(s) for ascertaining and relaying signal(s) of such height positions and wherein the controller receives such signal(s) to compare against the sought threshold of this height positions and does or does not command the “sample dispensing mechanism...configured to move the probe” to move the probe to the first/second height positions prior to starting the flow of cleaning water for either of the first and second discharges.
Claim 6 recites the limitation "the cleaning of the probe". There is insufficient antecedent basis for this limitation in the claim. Applicant may wish to amend the claim to merely recite “cleaning of the probe” without including the “the”.
Claim Rejections - 35 USC § 102
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 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sugimura et al. (US 2011/0293474 A1), referred to hereinafter as “Sugimura”.
Regarding Claim 1, Sugimura teaches an automatic analysis device 18 comprising:
a probe 16 that performs suction and discharge of a sample or a reagent (Fig. 2 and [0054]: “The sample probe 16 dispenses the sample in each dispensing cycle.”),
a cleaning nozzle 311c/d that discharges cleaning water toward the outside of the probe 16 (Fig. 8 shows two nozzles 311c and 311d which direct washing/cleaning water toward the outside of the probe 16. -- [0075]: “Water supply holes 311 c, detergent supply holes 311 d, upper waste liquid holes 311 e, and a lower waste liquid hole 311 f are formed in the main body 311.”),
a sample dispensing mechanism 41a that includes the probe and is configured to move the probe (Fig. 3 and [0059]: “The sample probe 16 changes in its horizontal position when the sample arm 10 is rotated by the arm driving mechanism 41a. The sample probe 16 changes in its vertical position when the sample arm 10 is vertically moved by the arm driving mechanism 41a.”); and
a controller 80 configured with the probe, the cleaning nozzle, and the sample dispensing mechanism ([0036]) to:
start a first discharge of the cleaning water from the cleaning nozzle when a tip end of the probe is at a first height position, which is below a bottom edge of the flow of the cleaning water from the cleaning nozzle (See Fig. 5 Sa2 and Sa5 showing the steps of lowering and washing the probe, and Fig. 7 showing the probe at the first height position receiving cleaning water through ports 311d. – Further, as the flow of water from the cleaning nozzle, as seen through Fig. 8, flows downward over the probe 16 and to the waste liquid port 311f, the tip end of the probe is thereby arranged within the flow of the cleaning water from the cleaning nozzle. – Further, as the probe 16 of Sugimura is positioned below a lower edge of the washing water supply ports in the first height position (Fig. 8), this first height position satisfies the tip end of the probe as being below a bottom edge of the flow of the cleaning water from the cleaning nozzle despite the “flow” flowing downwards to the waste port 311f given that Applicant’s instant invention must necessarily comprise such a flow given that the instant drawings Fig. 3 shows cleaning water contacting the side of the probe, wherein such water must necessarily flow downward along the probe ant to the waste tank 208 commensurately as in the prior art. – Further, in as much as is claimed, Sugimura commensurately provides the controller as starting a discharge of cleaning water when the probe is at a first height position, given that said first height position remains as not being particularly defined. At present, the instant recitation bases the first height position on a prospective flow which would not behave in the simplified manner Applicant has argued regarding the drawings Fig. 3. The claims provide no particular means for the first height position to be confirmed by the controller so as to start the flow of cleaning water (a signal-generating structure to signal the controller, or a pre-programming of the controller to move the probe to the first height position) and thereby indefinitely define the first height position. See further the 35 USC 112 section above.), and
start a second discharge of the cleaning water from the cleaning nozzle when the tip end of the probe is at a second height position above the first height position, such that the tip end of the probe is arranged within the flow of the cleaning water from the cleaning nozzle (See Fig. 5 Sa7 and Sa8 showing the steps of raising the probe and washing with cleaning water, and Fig. 8 showing the probe at the second height position receiving cleaning water through ports 311c. -- Further, as the flow of water from the cleaning nozzle, as seen through Fig. 8, flows downward over the probe 16 and to the waste liquid port 311f, the tip end of the probe is thereby arranged within the flow of the cleaning water from the cleaning nozzle. – Further, similarly as above, the second height position is not particularly defined, being based on a simplified prospective flow. See further the 35 USC 112 section above.),
wherein the first discharge of the cleaning water is stopped before the second discharge of the cleaning water begins (See Fig. 5 Sa6 – “stop detergent supply”.),
as in Claim 1.
Regarding Claim 3, the prior art meets the limitations of Claim 1 as discussed above. Further, Sugimura teaches the automatic analysis device discussed above wherein the first height position is below a lower end of a flow of the cleaning water (Fig. 6 shows a distal end length of the sample probe (interpreted as the tip of the probe) as below the height of the detergent supply ports 311d supplying a flow of cleaning water.), as in Claim 3.
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 4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Sugimura in view of Fürst et al. (US PAT 6,422,248 B1), hereinafter “Fürst”.
Regarding Claim 4, the prior art meets the limitations of Claim 1 as discussed above. Further, Sugimura does not specifically teach the automatic analysis device discussed above further comprising one or more additional discharges of the cleaning water when the tip end of the probe is higher than the first height position and lower than the second height position, as in Claim 4.
However, Fürst teaches a respective automated probe washing system wherein the probe is washed with additional discharge of cleaning water as it is raised from a cleaning cavity (thereby having a height between an upper and a lower height position) so as to ensure further decontamination of the probe (col. 3, line 13: “It is advantageous for the spraying to take place while the item to be washed is lifted out of the cavity.”).
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 analysis device of Sugimura such that one or more additional discharges of the cleaning water occur when the tip of the probe is higher than the first height position and lower than the second height position, such as suggested by Fürst, so as to ensure further decontamination of the probe; and would have a reasonable expectation of success therein.
Regarding Claim 6, the prior art meets the limitations of Claim 1 as discussed above. Further, Sugimura does not specifically teach the automatic analysis device discussed above wherein the cleaning of the probe with the cleaning water is ended by moving the probe upward during the second discharge of the cleaning water from the cleaning nozzle, as in Claim 6.
However, Fürst teaches a respective automated probe washing system wherein the probe is washed with additional discharge of cleaning water as it is raised from a cleaning cavity (thereby having a height between an upper and a lower height position) so as to ensure further decontamination of the probe (col. 3, line 13: “It is advantageous for the spraying to take place while the item to be washed is lifted out of the cavity.”).
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 analysis device of Sugimura wherein the cleaning of the probe with the cleaning water is ended by moving the probe upward during the second discharge of the cleaning water from the cleaning nozzle, such as suggested by Fürst, so as to ensure further decontamination of the probe.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Sugimura in view of Ravalico et al. (US 2014/0290706 A1), hereinafter “Ravalico”.
Regarding Claim 5, the prior art meets the limitations of Claim 1 as discussed above. Further, Sugimura does not specifically teach the automatic analysis device discussed above wherein the second discharge of the cleaning water has a shorter duration than the first discharge of the cleaning water, as in Claim 5.
However, Ravalico teaches a respective automated analyzer probe washing system (Fig. 3) wherein supplemental probe washes are performed to minimize sample carryover between suction and dispensing operations ([0024]). Ravalico further states “Unfortunately, supplemental washes require additional instrument cycles that can degrade system specimen throughput.” ([0024]), wherein one skilled in the art would thus find it obvious to minimize the time spent performing a supplemental wash so as to maintain throughput. Further note that the system of Ravalico “is not limited to a specific timing duration or over-lap time between the termination of internal and external washes.” ([0022]).
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 automated analysis system of Sugimura wherein the second discharge of the cleaning water has a shorter duration than the first discharge of the cleaning water, such as suggested by Ravalico, so as to reduce sample carryover between pipetting operations while maintaining high sample throughput; and would have a reasonable expectation of success therein.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Sugimura in view of Wikholm et al. (US PAT 11,590,491 B2), hereinafter “Wikholm”.
Regarding Claim 7, the prior art meets the limitations of Claim 1 as discussed above. Further, Sugimura does not specifically teach the automatic analysis device discussed above a first acceleration when the tip end of the probe rises from the second height position is higher than a second acceleration when the tip end of the probe rises during suction and discharge, as in Claim 7.
However, as the throughput capability of the device is a property that can be modified by adjusting the speed of probe movement during pipetting operations, as evidenced through Wikholm (“additional control parameters can be derived from the time constant in a manner similar to those described above, such as speed of pipette tip 3 removal from the liquid 61 after the steady state response has been reached.” – “methods described herein comprise confirming in a timely manner that an equilibrium state has be achieved, so that the execution of the pipetting operation can proceed efficiently.”), the precise acceleration and speed value would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed first and second probe speed/acceleration cannot be considered critical. Thus, one of ordinary skill in the art would have optimized through routine experimentation the acceleration of probe movement so as to obtain a maximized throughput (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Further, Wikholm discusses optimizing the device to prevent cavitation and tunneling, both of these issues being explored in the prior art relating to the speed at which a probe ascends and descends to/from a liquid solution. Thus, one skilled in the art would find it obvious to provide a slower speed (of the max throughput speed) during insertion/removal operations so as to prevent tunneling, cavitation, splashing, etc.
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Sugimura in view of Shimase et al. (EP 1,391,734 B1), hereinafter “Shimase”.
Regarding Claim 8, the prior art meets the limitations of Claim 1 as discussed above. Further, Sugimura does not specifically teach the automatic analysis device discussed above further comprising: a flow sensor, including at least one of a liquid contact detection sensor and a pressure sensor; wherein the controller is configured to confirm a range of a flow of the cleaning water based on a signal from the flow sensor, as in Claim 8.
However, Shimase teaches a respective automated analysis device comprising a supply tank 10 for washing water 11, a fluidic line for coupling the washing water 11 to the probe 1, and a pressure sensor 13 configured to confirm the flow of washing water 11 to the probe 1 and detect a clog in the probe and/or fluidic lines for supplying washing water (See para. [0025] and Fig. 1.). Therein, this assembly provides ana arrangement capable of detecting clogs, thereby reducing error due to clogged fluidic lines and/or probes.
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 analysis device of Sugimura further comprising: a flow sensor, including at least one of a liquid contact detection sensor and a pressure sensor; wherein the controller is configured to confirm a range of a flow of the cleaning water based on a signal from the flow sensor, such as suggested by Shimase, so as to reduce error due to clogged or deteriorated fluidic lines supplying washing water to the outside of the probe; and would have a reasonable expectation of success therein.
Regarding Claim 9, the prior art meets the limitations of Claim 8 as discussed above. Further, Sugimura does not specifically teach the automatic analysis device discussed above wherein positions of both ends in a horizontal direction of the flow are confirmed by detecting a presence or absence of the cleaning water while moving the probe in the horizontal direction, and an upper end position of the flow is confirmed by detecting the presence or absence of the cleaning water while moving the probe in a vertical direction, as in Claim 9.
However, the recitation “positions of both ends in a horizontal direction of the flow are confirmed by detecting a presence or absence of the cleaning water while moving the probe in the horizontal direction, and an upper end position of the flow is confirmed by detecting the presence or absence of the cleaning water while moving the probe in a vertical direction” is drawn to a process recitation. As the claims are drawn to a device, such process recitation is not afforded patentable weight when the prior art device is capable of performing the claimed process. "Apparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc. – MPEP 2114(II). Applicant may wish to amend the Claim to recite “wherein the controller is further configured to...”.
Further, mere duplication of the pressure sensor to confirm a flow at multiple points within the flow conduit of Sugimura, as in the instant Claim 9, is seen as a mere obviouys matter of design choice given that mere duplication of parts has no patentable significance unless a new and unexpected result is produced – see MPEP 2144.04(VI)(B).
Herein, one skilled in the art would find it obvious to provide additional pressure sensors of Shimase to Sugimura so as to provide further redundancy in clog detection, thereby further reducing error related to clogging of fluidic lines, and wherein this arrangement would further allow the device of modified Sugimura to detect a specific location of a clog based on its proximity to members of an array of sensors.
Response to Arguments
35 USC 112
Applicant’s amendments to Claims 1 and 6 sufficiently overcome those 35 USC 112(b) indefiniteness rejections of Claims 1 and 6 set forth in the previous office action. Thus, those indefiniteness rejections of Claims 1 and 6 under 35 USC 112(b) are hereby withdrawn.
Note that a new grounds of rejection under 35 USC 112(b) over Claims 1 and 6 is provided above in the body of the action as necessitated by Applicant’s amendments.
35 USC 102 and 103
Applicant’s arguments are on the grounds that the prior art of Sugimura allegedly does not teach the tip end of the probe as arranged within the flow of the cleaning water from the cleaning nozzle, as required by the amended Claim 1, the probe tip end of Sugimura allegedly being below said flow of cleaning water.
Applicant’s arguments are not persuasive because, as discussed above in the body of the action, the probe tip end of Sugimura is arranged within the flow of the cleaning water as the cleaning water flows along the probe 16 and downwards to the waste port 311f, contacting the probe tip end therebetween as seen through Fig. 8. Applicant may wish to define this spatial relationship through the relative position of the nozzle, which is static, relative to the probe tip end, rather than the flow of cleaning water, which de facto comprises more than the simplified flow shown in Applicant’s drawings Fig. 3.
Thus, Examiner maintains the rejection of Claim 1 under 35 USC 102(a)(1) as anticipated by Sugimura.
Applicant further argues that the dependent claims are allowable for depending from the allegedly allowable Claim 1, and that none of the additional references remedy the alleged deficiency of Claim 1. However, as discussed above, no such deficiency in Sugimura exists in Claim 1 and none of the additional references are depended upon for curing any deficiency in Claim 1. As such, the dependent Claims 3-9 are not patentable merely for their dependence on Claim 1.
Conclusion
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/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798