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 .
This action is in response to applicant’s “Remarks”, filed July 09, 2026. The amendments therein have been thoroughly reviewed and entered. Any previous objection/ rejection not repeated herein has been withdrawn. Because the instant claims are materially different from those previously examined, applicant’s amendments necessitated the modified/new ground(s) of rejection presented in this Office action. Accordingly, this action is Final. See MPEP § 706.07(a).
Applicant's arguments have been thoroughly reviewed but are deemed moot in view of the amendments, withdrawn rejections, new and/or modified grounds for rejection, necessitated by the amendments discussed below.
Claim Interpretation
Applicant's response to the 112(f) discussion is persuasive. The “cleaning mechanism” limitation identified in the previous action was deleted. The original 112(f) issue with respect to this limitation is therefore moot. See MPEP 2181. The Office has interpreted the “controller configured to” as a computer or equivalents thereof. That is, the “controller configured” has been interpreted in the context of the underlying specification and field of the art (see MPEP 2111.01). The claimed “controller configured to” cannot be reasonably interpreted as a mechanical type controller, such as valve or a discrete electronic device (e.g., solenoid, transistor, etc.) Functional/process limitations following the “controller configured to” have been considered and received patentable weight. See MPEP 2114 and 2173.05(g).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claim 7 is rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention.
Regarding amended claim 7, applicant’s original disclosure (US 2025/0044311) states that deterioration causes the peak value of electrical impedance to decrease and that a fault is determined when the peak value is lower than a threshold. See the published specification, see Figs 6A-7 and the accompanying description of the normal, deteriorated, and fault states at para [0052] et seq. The disclosure also describes predicting future impedance from its change over time and outputting a deterioration or maintenance time. It does not describe an electrode, or its impedance peak, deteriorating by exceeding a fault threshold. Claim 7 now recites the opposite threshold direction, which is considered new matter. See MPEP 2163 and 2163.06.
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.
Claims 1-3 and 5-9 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Applicant’s instant amendments to the claims overcome most of the original rejections under 112(b). However, claim 1 now recites “a controller configured to…determine that the reaction container into which a detergent or water has been dispensed by the reagent dispensing mechanism is in an empty state”. The scope of “empty state” remains unclear. A container containing detergent or water is literally not empty. The claim does not specify whether the phrase means that 1) no sample has been dispensed, 2) no sample-reagent mixture is present, 3) that the container was empty immediately before detergent or water was dispensed, or 4) the container presently contains only detergent or water. The examiner recommends claim 1 include control step in which the reagent dispenser removes the sample-reagent mixture to create an empty container before the step of “determining that the reaction container…is in an empty state”. The scope of the claim cannot be determined.
Claim 2 recites the phrases “the reaction containers”, “at least some of the reaction containers”, and “other reaction containers”, which lack clear antecedent basis because parent claim 1 only positively recites “a reaction container”. This lack of agreement regarding the number and identity of containers is confusing and indefinite. Also, the phrase “the controller is further configured to perform ... and measures an electric impedance” should be corrected to --and to measure-- or --and measure-- for clarity. Further it remains is unclear from the claim what elements/steps are included in the “immersion cleaning”.
Claim 3 recites controller configured to… measure an electric impedance of the one or more segmented electrodes”. Claim 1 and the written description describe measuring the impedance of the piezoelectric element through a selected segmented electrode. The recitation in claim 3 that the impedance is “of” one or more of the segmented electrodes is unclear whether the claim requires the intrinsic impedance of an electrode or the piezoelectric element impedance corresponding to the selected electrode. Claim 3 also recites the confusing plural reaction container terminology and the unclear contents of the reaction container.
Claim 5 also recites the use plural reaction containers without antecedent basis. The claim recites “one of the first voltage or the second voltage” while a reaction container containing only detergent or water is stopped at the stirring position. Claim 1 appears to require the smaller second voltage under that condition. The first-voltage alternative in claim 5 is therefore unclear in relation to the limitations in claim 1.
Claim 7 now recites “the controller is further configured to predict and output a time at which one of the segmented electrodes will deteriorate and exceed a fault determination threshold”. This is confusing and indefinite since an electrode does not itself “exceed” a threshold, and the claim does not identify the measured quantity that allegedly exceeds the threshold. As discussed above, the threshold direction is also inconsistent with the disclosed decrease of the impedance peak toward a below threshold fault state. Thus, it is unclear of the predicted event is an impedance value rising above a threshold, lowering below a threshold, or a separate deterioration measure crossing a threshold. Clarification is required.
New claim 8 recites “the reaction containers into which only the detergent or the water is dispensed”, which lacks a clear antecedent basis for the reasons delineated above. The numerical comparison is also operation dependent without defining the relevant group of reaction containers or the time at which their number is determined.
Prior art
Note the MPEP 2173.06(II) states, where there is a great deal of confusion and uncertainty as to the proper interpretation of the limitations of a claim, it would not be proper to reject such a claim on the basis of prior art. A rejection should not be based on considerable speculation about the meaning of terms employed in a claim or assumptions that must be made as to the scope of the claims. However, in the interest of compact prosecution, the examiner will apply the closest prior art against claims 1-3 and 5-9, as best understood.
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.
Claims 1-3, 5, 6, 8 and 9, as best understood, are rejected under 35 U.S.C. 103 as being unpatentable over Inabe (JP 201096638) in view of Sugiyama et al., (US 2011/0020949; hereinafter “Sugiyama”) and Nakasawa et al., (US 2019/0346468; hereinafter “Nakasawa”).
Regarding claim 1, Inabe teaches an automatic analyzer comprising:
a reaction container 6;
a sample dispensing mechanism 18 that dispenses a sample into a reaction container;
a reagent dispensing mechanism 19 that dispenses a reagent into the reaction container to form a mixture of the sample and reagent;
a stirring mechanism 14 that includes a piezoelectric element 4 and a plurality of segmented electrodes 5, and electrode selector 3, and individual or selected combination impedance measurements see [0018]-[0024], Figures 1 and 3;
a reaction disk 13 that rotates and stops the reaction container;
a measurement unit 15 configured calculate a component of the sample;
an impedance measuring circuit configured to measure electrical impedance of the piezoelectric element (Inabe teaches detector 9 and recording unit 10 measuring and storing the voltage/current waveform and electrical impedance of piezoelectric element 4, including frequency characteristics at and near resonance, see Inabe [0009] et seq.),
and
a controller 1 configured to:
determine that the reaction container is stopped at a stirring position (Inabe moves the reaction container 6 from the sample and reagent discharge position to the stirring position 22 before mixing and analysis, see Figs. 2 and 4 and corresponding Best Mode discussion).
apply a first voltage to stir the sample and reagent mixture with ultrasonic waves when the reaction container stops at the stirring position (Inabe teaches applying a drive voltage to piezoelectric element 4 to generate sound waves that mixes the sample and reagent at stirring position 22, see para [0015] et seq., and Fig. 4),
cause (apply) a second voltage that is smaller than the first voltage to the one or more plurality of segmented electrodes and measure electrical impedance (Inabe teaches applying a diagnostic voltage to the piezoelectric element before stirring, measuring the electrical impedance, and making the applied diagnostic voltage lower than the sound-output/stirring voltage to avoid deterioration from reflected waves (see Inabe, paras [0016] et seq., and Figs 1, 3 and 4); and during operation determine a sample-free or “empty state” reaction container into which detergent or water is dispensed by the reagent dispensing mechanism and perform the impedance measurement instead of stirring when that container stops at the stirring position.
Inabe does not specifically teach relocating its diagnostic to a sample-free detergent/water maintenance container or substituting the diagnostic voltage for the stirring operation in that maintenance cycle.
In the related art of automatic analyzers, Nakasawa teaches that, while analysis continues, the controller selects a cleaning-target reaction container, does not dispense a sample, and has reagent dispensing mechanism 9 dispense undiluted detergent from the reagent disk into the reaction container. Nakasawa expressly calls the vessel an "empty reaction container." The detergent containing container then repeatedly rotates and stops during soaking. Purified water is subsequently delivered and a blank measurement is performed. Maintenance is performed during the operation state while other containers undergo sample analysis. (see Nakasawa [0038] et seq. and Figs 4-5). Nakasawa further teaches that agitation of the detergent at step S50 is not indispensable. Thus, Nakasawa identifies an existing maintenance interval at the agitation position in which stirring may be omitted, while Inabe identifies the known low-voltage impedance diagnostic performed at the stirring position. Since the intensity of the reflected wave in the reaction vessel 6 in Inabe is different depending upon its contents, it is inherent that the control unit in Inabe is capable of determining when a difference occurs in the electrical impedance based on whether the reaction vessel includes water/ detergent supplied by the cleaning mechanism 16 or reaction solution liquid. Inabe discloses that this configuration improves the reliability of the piezoelectric element based on the difference of the electric impedance of a measured reflected soundwave received by the control unit with respect to the contents of the reaction container and stopping output of the sound wave after comparing them to thresholds to determine whether there exists an abnormality (deterioration) in the electrode.
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to configure Inabe's controller to perform its known lower-voltage piezoelectric-impedance diagnostic on Nakasawa's scheduled, sample-free detergent-containing reaction container when the container reaches the stirring position since Nakasawa teaches the same type of automatic analyzer, the same reaction-disk transport, an empty/sample-free cell supplied by the reagent dispenser, continued analysis in other cells, and an optional detergent-agitation step. Replacing that optional agitation with lnabe's diagnostic impedance measurement operation is a substitution of one known stirring station operation for another and predictably tests the stirrer during an already available maintenance cycle. The modification avoids consuming a sample-containing cell and avoids adding a separate diagnostic cycle for increased throughput reasons (see Nakasawa para [0038], [0044]-[0045], [0056]-[0058], and [0079]).
The examiner believes that Inabe teaches the stirring mechanism comprises a plurality of segmented electrodes 5 and a piezoelectric element 4. However, if not then Sugiyama specifically teaches a piezoelectric element 30 divided into segments (multiple electrodes 32) used as sound sources, and selection of different segments (see para [0022] et seq. and Fig. 2). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used Sugiyama's divided piezoelectric element in Inabe since both references use a piezoelectric sound source in the same automatic-analyzer environment. Sugiyama teaches that multiple segments permit the irradiation position and applied intensity to be selected for liquid amount and properties (see Sugiyama paras [0031] et seq.) Inabe already teaches an electrode selector and individual electrode impedance measurement (see Inabe claim 1). The substitution therefore retains each element's established electrical and acoustic function and predictably permits electrode-specific stirring and diagnosis. See MPEP 2143.
Regarding claim 2, Nakasawa teaches component analysis, detergent containers accessible to reagent dispensing mechanism 9; omission of sample dispensing into cleaning target cells; dispensing of detergent into those cells; optional agitation; repeated rotation and stopping during soaking; aspiration of the detergent; delivery of purified water; and analysis in other cells at the same time (see Nakasawa [0026], [0038]-[0045], [0056)-[0058], [0074), [0079), Figs 1, 4, and 5. Thus, applying lnabe's diagnostic impedance measurement operation to the Nakasawa maintenance cell for the reasons stated for claim 1 yields a background-maintenance arrangement.
Regarding claim 3, Inabe teaches multiple electrodes on the piezoelectric element 3, applying voltage to a selected electrode 5, and individually measuring electrode-associated impedance, (see Inabe para [0018] et seq. and Figs 1 and 3, and claims 1 and 4). As discussed above, Sugiyama expressly teaches a segment piezoelectric element and selection or reselection of different segments based on liquid amount and properties (see Sugiyama para [0031] et seq. and Fig. 5). Nakasawa supplies the common sample free detergent container for the reasons stated above. Sequentially selecting the electrodes while that maintenance container is stopped would predictably obtain electrode specific diagnostic values under the same controlled liquid load and would avoid container-to-container variability.
Regarding claim 5, Sugiyama teaches that high throughput automatic analyzers commonly use a plurality of stirring mechanisms 7b-1 and 7b-2 at respective stirring positions (see Sugiyama para [0034] et seq. and Figs. 6-7). Nakasawa teaches distributing cleaning-target containers among analysis containers to preserve throughput, (see Nakasawa [0038] et seq.). It would have been obvious to operate Inabe's diagnostic impedance measurement at the respective available stirring stations as scheduled sample free maintenance cells arrive, including concurrently when the disk geometry places different maintenance cells at different stations. Parallel use of already provided stirrers performs the same diagnostic step independently and predictably minimizes maintenance time.
Regarding claim 6, Inabe teaches establishing and storing the normal impedance frequency characteristic at or near resonance, measuring the current impedance characteristic, comparing the result with the normal state, and declaring an abnormality when the impedance difference exceeds a predetermined value (see para [0019] et seq. and Fig. 3). Representing a resonance-frequency characteristic by its peak value and setting a corresponding normal state threshold are predictable implementations of Inabe's express normal-curve comparison. The choice reports the same diagnostic information in a suitable form for the controller and produces no new function.
Regarding claim 8, Sugiyama teaches ten piezoelectric segments Nakasawa ·teaches assigning a maintenance cell only periodically, for example, one cleaning target every five operation cycles while other cells remain in analysis (see Nakasawa para [0038] et seq., and Figs 4 and 7. In the combined analyzer, the ten segmented electrodes therefore exceed the number of detergent only containers presented in an individual maintenance interval. Measuring multiple segments during the available stop is the predictable electrode by electrode diagnostic operation for the reasons delineated with respect to claim 3.
Regarding claim 9, Inabe teaches the controller switches the measurement electrode 5 with electrode selector 3 and explains that an electrode located at a height where the reaction container is not filled produces a different impedance because the reflected wave condition differs (see para [0022] et seq. and Figure 3(d)). Sugiyama
teaches selecting piezoelectric segments according to the amount and properties of liquid in the reaction vessel and expressly uses a ten-segment vertical arrangement (see Sugiyama para [0031] et seq. and Figure 5). Applying that known height-responsive selection to Nakasawa's detergent filled maintenance cell predictably selects segments acoustically loaded by the liquid and avoids segments above the liquid level.
Claim 7, as best understood, is rejected under 35 U.S.C. 103 as being unpatentable over Inabe, Sugiyama, and Nakasawa, as applied to claim 1 above, in further view of Ridolfo (US 6,735,549).
The combination of Inabe, Sugiyama, and Nakasawa teaches recurring electrode specific impedance measurements during scheduled maintenance and comparison with a fault criterion, as set forth above. The combination does not expressly predict the future time at which the criterion will be reached. Ridolfo teaches periodic or continuous acquisition of measurements indicative of component condition, trend analysis of measurement parameters over time, alert thresholds, curve fitting, prediction of remaining component life, and output of a date or time of likely failure (see Ridolfo, Abstract; col. 5, lines 15-55; col. 6, lines 1-45 and Figs 1, 2 and 8-10).
It would have been obvious to one of ordinary skill in the art prior to effective filing date of the claimed invention apply Ridolfo's established trend to threshold predictive maintenance function to the successive electrode specific impedance values produced by the combined analyzer. Inabe already treats impedance as a condition indicator and stores a normal reference, Nakasawa supplies repeated maintenance opportunities and Ridolfo teaches that electrical component measurements can be trended to predict remaining life and schedule service before failure. The modification would predictably output the time at which the measured degradation trend reaches the fault criterion, allowing an electrode to be serviced before it disrupts analysis.
Response to Arguments
Applicant's central eligibility argument in the Remarks filed on July 09, 2026 with respect to the previous 101 rejection is persuasive, notwithstanding repetitive and inapplicable references in applicant’s to “claim 12” (Remarks- see page 67), “a materials research protocol” (see page 66), “plasma processing apparatus” (see page 94) and a “heating apparatus” (see page 95). Claims 1-3 and 5-9 are considered patent eligible under 35 U.S.C. 101. Applicant's argument that neither Sugiyama nor Inabe teaches the complete amended arrangement is persuasive with respect to previous anticipation rejections but does not defeat the new 103 combination. The new rejection identifies the teachings of each reference separately and states why a skilled person would have combined them. The examiner contends that no hindsight dependent has been applied in this rejection. Nakasawa itself teaches the sample free detergent cell, operation state maintenance, continuing analysis in other cells, repeated stopping, and the throughput benefit. No bodily incorporation of the references is required. The proposed modification changes the controller schedule so that Inabe's known diagnostic process is performed during Nakasawa's optional agitation interval, using Sugiyama's known segmented piezoelectric element. The references do not teach away. Nakasawa states that detergent agitation is not indispensable, Inabe teaches a low diagnostic voltage specifically to avoid damage, and Sugiyama teaches selectable segments and drive intensity. Each teaching is compatible with the proposed operation. The modification has a reasonable expectation of success because it uses the same piezoelectric element, drive/measurement path, liquid-loaded reaction-vessel geometry, and stirring position already used by Inabe and Sugiyama. Nakasawa changes the contents and scheduling of the selected cell, not the underlying electrical measurement principle. The asserted throughput advantage is addressed by the prior art itself. Nakasawa distributes maintenance cells and continues ordinary analysis to minimize loss of processing capability, and substituting the diagnostic operation into an existing optional agitation interval preserves that benefit. Applicant’s outstanding response has not provided persuasive evidence of unexpected results, criticality, or another objective indicium sufficient to outweigh the combined teachings.
Citations to art
In the above citations to documents in the art, an effort has been made to specifically cite representative passages, however rejections are in reference to the entirety of each document relied upon. Other passages, not specifically cited, may apply as well.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure include:
i. JP 4408404 (see attached machine-generated English translation) which teaches an automatic analyzer including a rotating reaction disk 36 including reaction vessels 35 therein, and arranged along the circumference of the reaction disk are reagent probes 20, 21, sample probes 15, 16, ultrasonic agitators 30, 31, 32 (which include electric probes), an analyzer unit 50, 51, and a reaction container cleaning mechanism 45 configured to supply cleaning solution or water to the reaction containers, and a control unit 60 configured to control each mechanism.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to P. Kathryn Wright whose telephone number is (571)272-2374. The examiner can normally be reached between9:30am-7:30 pm EST.
Examiner interviews are available via telephone and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
E-mail communication Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS Web (using PTO/SB/439) or Central Fax (571-273-8300):
Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached on (571) 270-36383638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P. Kathryn Wright/Primary Examiner, Art Unit 1798
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