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 papers filed December 31, 2025. The amendments have been thoroughly reviewed and entered. Any previous objection/ rejection not repeated herein has been withdrawn. New and/or modified grounds for rejection, necessitated by the amendments, are discussed.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the new limitation in claims 1 and 11 “each of the at least one folded first electrode and the at least one second electrode is divided by a predetermined length and width to create a (plurality) of divided electrodes” does not find support in the specification. This can be reasonably interpreted as both the first and second electrode are divided…to create plurality of divided electrodes. However, the specification discloses an electrode 210 (interpreted as corresponding to the first electrode) on the constant temperature water 209 side of the piezoelectric element 201 is folded back to the opposite side along the lower end surface of the element as illustrated in FIG. 2. An electrode (second electrode) on the surface opposite to the constant temperature water 209 side is divided by predetermined length and width as illustrated in the diagram inside the broken line. Each divided electrode 211 is connected to each pin of the connector 112 on a one-to-one basis.
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.
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:
“maintenance kit” in claims 1, 6 and 11, corresponds maintenance kit shown in FIGS. 3 and 4, which includes a digital direct synthesizer 401, output terminal 403, amplifier 402, a connector 306, wiring 405, 409, resistor 406, log amplifier 408, operational amplifier 407, and a micro control unit 410, see at least para [0046] of applicant’s US 2024/0230693 and structural equivalents thereof;
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.
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 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 1-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) 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, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The new limitation recited in the independent claims 1 and 11 that “each of the at least one folded first electrode and the at least one second electrode is divided by a predetermined length and width to create a (plurality) of divided electrodes” does not find support in the specification. The scope of the claim can be reasonably interpreted as both the first and second electrode are divided to create a plurality of divided electrodes. However, applicant’s specification discloses an electrode 210 (interpreted as corresponding to the first electrode 210) disposed on the constant temperature water 209 side and along the lower end surface of the piezoelectric element as illustrated in FIG. 2. However, the first electrode 210 itself is not disclosed as “divided”. That is, the first electrode is a continuous electrode. The second electrode 211 is defined as the “divided electrode”, wherein divided second electrode includes multiple portions capable of connecting with multiple pins on the connector 112 in a one-on-one basis, as shown as the broken line of reference number 211, in Fig. 2. While both the first electrode 210 and second 211 electrode are disposed on the same piezoelectric element 201, both electrodes 210, 211 they are separated from each other by predetermined length and width on the same piezoelectric element but do not find support as constituting the “divided electrodes”. Only the second electrode 211 is the “divided electrode” configured to connect to a respective pin on the connector 112 in a one-to-one basis (Fig 2. and see para [0041] et seq.) These amendments are considered new matter.
Similarly, independent claim 6 recites “the automatic chemical analyzer including…a stirring mechanism including a piezoelectric element… the piezoelectric element including divided electrodes”. However, thr scope of this claim does not find support in the specification as filed. The piezoelectric element includes separated a first and second electrode, wherein only the second electrode is divided. The broader recitation that the piezoelectric element includes divided electrodes is considered new matter.
In addition, the claims now recite the piezoelectric element includes at least one first electrode and at least one second electrode. This use of multiple first and second electrodes on the same piezoelectric elements does not find support in the specification as filed.
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 1-15 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.
Independent claims 1 and 11 are now directed to an “automatic chemical analyzer capable of determining an internal abnormality” and an “automatic chemical maintenance method for determining an abnormality”, respectively. However, it is unclear how the automatic chemical analyzer and automatic chemical maintenance method are capable of performing the intended use (i.e., chemical analysis) since the body of the claims does not include any means to analyze a chemical. The specification recites the analyzer and method measures/analyzes the absorbance characteristics of a mixture of specimen and the reagent using an absorbance meter 110. The analyzer and method alone do not determine an internal abnormality. It only upon the connection of a maintenance kit to the stirring mechanism in the chemical analyzer which detects any abnormality of the divided electrodes used to mix the chemicals in a reaction vessel. The examiner recommends applicant positively recite an absorbance meter to the body of claims 1 and 11 that is configured to perform chemical analysis. Claims must include an element capable of performing the intended purpose (i.e., chemical analysis). The determination of an internal stirring abnormality is not performed by chemical analysis. Rather, it is the maintenance kit in conjunction with a stirring mechanism in the automatic chemical analyzer that work to determine a stirring abnormality, not some vague “internal abnormality”.
Furthermore, it is not clear what applicant means by “determining an internal abnormality”. It is not clear from the claim what is meant by an internal abnormality versus an external abnormality. This is confusing and indefinite.
In addition, independent claims 1, 6 and 11 recite that the measurement of an impedance spectrum comprising an absolute value (i.e., magnitude) of the impedance in the piezoelectric element and a phase difference between a voltage applied to a “respective divided electrode” and a current is capable of determining whether or not each of the divided electrodes on the second electrode have an abnormality. However, it unclear how measuring the impedance alone without some comparison step between the measured impedance spectrum performed by a maintenance kit and previously stored impedance spectra of “normal” piezoelectric elements would result in any determination of abnormality. It remains unclear what applicant considers a “normal piezoelectric element” and “abnormal piezoelectric element”. The claims should include what measured impedance threshold/range the kit uses to determine whether or not each of the divided electrodes are normal or abnormal relative to previously stored normal measurements. The examiner recommends including at least the limitations of claims 3, 4 and 5 into claims 1, 6 and 11 so that the invention is at least capable of performing the intended use of determining an abnormality (in the stirring mechanism).
Again, the terms “normal” and “abnormal” as recited in the claims are considered relative terms which render the claims indefinite. The terms “normal” and “abnormal” are not defined by the claims, and 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 “reaction vessel” in claims 1 and 5 are not linked to any of the other elements of the claim. It is unclear what purpose the reaction vessel serves in the claims. The examiner recommends applicant structurally link the reaction vessel to the stirring mechanism and thermostatic bath.
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 1-15, as best understood, are rejected under 35 U.S.C. 103 as being unpatentable over Shiga et al., (JP 2015-25678; hereinafter “Shiga”, see attached machine-generated English translation) in view of Katsuhiro et al., (JP 2003-35715, see attached machine-generated English translation).
As to claims 1, 6 and 11, Shiga teaches an automatic chemical analyzer, maintenance kit and method of operating the same comprising:
a reaction vessel 5 capable of accommodating at least a pipetted specimen and a reagent;
a stirring mechanism 12 including a thermostatic bath 7, a function generation circuit, an amplifier circuit, a relay group (all inherent parts of the ultrasonic stirring mechanism 17 and drive unit 19), and a piezoelectric element mounted on the thermostatic bath, the piezoelectric element including at least one first electrode 16 located on a first side of the thermostatic bath and at least one second electrode 18 located on a second opposite side of the thermostatic bath (see Fig. 5),
the at least one of the first electrode 16 and the at least one second electrode 18 are divided (separated) by a predetermined length and width and at least one of the electrodes create a plurality of divided electrodes 15 and 17;
an interface unit 19 or 20 connectable to a maintenance kit.
Note that the maintenance kit is not positively recited in claim 1 and therefor it is considered an intended use in claim 1 and has not received patentable weight. Nevertheless, Shiga teaches a maintenance kit (part of the existing stirring mechanism) measures, for each of divided electrodes, an absolute value of an impedance of the piezoelectric element and a phase difference between a voltage applied to the divided electrode and a current and determines whether or not there is an abnormality of each divided electrode based on a measurement result. That is, Shiga discloses piezoelectric element 16 is driven by the voltage applied to the electrodes which mechanically expands and contracts to generate an ultrasonic wave 20, but at the same time, a voltage is also generated in the applied waveform detection electrode 15 provided in the piezoelectric element 16 by a piezoelectric action, so that it is generated by the applied waveform detection unit. The voltage is measured and fed back to the control unit 23.
Shiga discloses the control unit 23 compares the current output waveform with the comparison waveform set from the output waveform of the applied waveform detection unit 22 when the required stirring state is obtained in advance, and the similarity between both waveforms is set. The voltage applied to the piezoelectric elements 16 and 18 are adjusted based on a command from the control unit 23 until it falls within the range. The current state is grasped from the detected waveform and the control is advanced. Shiga teaches that when it is determined that the number of times outside the threshold is not 1, the number of times outside the threshold is 2 or more, and the control unit 23 cannot perform adjustment, and the operation unit 1 performs the stirring operation during the analysis. An abnormality display is displayed (step S111), and the analysis based on the abnormality information of the stirring operation is terminated because an accurate analysis cannot be performed, and the analysis is started again after the operator or the manager responds.
Shiga does not explicitly disclose the first electrode is folded from the first side to the second side of the thermostatic bath. In the related art of ultrasonic devices used to stir the contents of reaction vessels in automatic analyzers, Katsuhiro discloses a reaction vessel 21, stirring mechanism 7 including a thermostatic reaction bath 4, sound source drive section 36 is a drive circuit section 1 for generating a voltage waveform to be applied to the power source 14, the piezoelectric element 30 and the relay circuit 3 for selecting the electrode 32 to which the voltage is applied. The stirring mechanism 7 is detachably attached by being immersed in the constant temperature water of the reaction tank 4. Katsuhiro teaches the stirring mechanism comprising a first electrode 31 and a second electrode 32, wherein the first electrode 31 is flexible and capable of folding between a first side and a second side of the thermostatic bath. Katsuhiro teaches that the use of a flexible electrode adds an expanded degree of freedom in layout design of the automatic analyzer such that the system can be downsized.
Accordingly, because both Shiga and Katsuhiro are directed to the detection of abnormal piezoelectric elements that cannot obtain the necessary sound intensity for stirring even when applied power depending on the irradiation condition of sound waves to the object to be stirred, often due to individual differences or deterioration over time of the electrodes, which affects the analysis results. It would have been obvious to one of ordinary skill in the art at the time the claimed invention was effectively filed to have substituted the first electrode of Shiga with the foldable electrode of Katsuhiro, since Katsuhiro indicates the use of foldable electrodes in a stirring mechanism adds an additional degree and adjustability in the overall design of the automatic analyzer.
As to claims 2, 7, and 12, modified Shiga discloses the maintenance kit detects a frequency at which the absolute value of the impedance of the piezoelectric element is minimized and the absolute value of the impedance (wherein the “absolute value” is considered the magnitude), for each of the divided electrodes, and determines whether or not there is the abnormality of each divided electrode. That is, Shiga discloses the variation of the resonance frequency can be absorbed by sweeping the frequency within the range where the resonance frequency is estimated to exist, but with respect to the voltage, it is attempted to simultaneously drive a plurality of ultrasonic wave generation sources. In this case, the driving waveform may change due to a decrease in impedance as a total load and an interaction with an adjacent electrode, and thus the intensity of generated ultrasonic waves may change.
Note that the maintenance kit is not positively recited in the automatic chemical analyzer claims 1-5 and therefore has not received patentable weight. Also with respect to claims 6-15 it has been held that the recitation that an element is "capable of" performing a function is not a positive limitation but only requires the ability to so perform. It does not constitute a limitation in any patentable sense, see MPEP 2114 I.
As to claim 3, 8 and 13, modified Shiga discloses the maintenance kit determines whether or not each of the divided electrodes has an abnormality by using the frequency at which the absolute value (magnitude) of the impedance of the piezoelectric element is a minimum value and a predetermined range of the absolute value of impedance, for each of the divided electrodes set in advance.
As to claims 4, 9, and 14, modified Shiga discloses the maintenance kit measures an impedance spectrum for the plurality of divided electrodes in a predetermined number of normal piezoelectric elements advance to obtain an impedance spectra, and sets the frequency at which the absolute value of the impedance of the piezoelectric element is the minimum value and the normal range of the absolute value of impedance, for each of the divided electrodes, based on the impedance spectrum (sweeping the frequency). Note that maintenance kit is not positively recited in the automatic chemical analyzer set of claims 1-5 and therefor is not given patentable weight. Also the
As to claim 5, 10, and 15, modified Shiga discloses the maintenance kit measures the impedance spectrum for the plurality of divided electrodes in at least on of the predetermined number of the normal piezoelectric element under conditions in water and air, and removes an influence of air reflected wave received in a thermostatic bath by performing a smoothing process on the impedance spectrum measured in water.
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.
Response to Arguments
Applicant's claim amendments and arguments, filed December 31, 2025, have been entered and considered by the examiner. Applicant’s instant amendments to claims 1, 6, and 11 (and the claims depending therefrom) have overcome the previous 35 USC 101 set forth in the Official action filed October 1, 2025. Specifically, the amended claims include now include specialized physical equipment that are integrated into a practice technical application (see pages 11-16 of applicant’s Remarks/Arguments).
Applicant’s arguments with respect to the previous 35 USC 102 rejections of claims 1-20 have been considered but are moot due to the new ground of rejection which does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
No claims are allowed.
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 on 9:30am-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) 270-3638. 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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