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 June 10, 2026. The amendments therein have been thoroughly reviewed and entered. Any previous objection/ rejection not repeated herein has been withdrawn.
Applicant's arguments have been thoroughly reviewed but are deemed moot in view of the amendments, withdrawn rejections, and new and/or modified grounds for rejection, necessitated by the amendments as discussed below.
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 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) 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):
(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). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) 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). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) 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) 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) 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) 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:
i. “stirring unit(s)”, as recited in the claims has/have been interpreted as having a piezoelectric element 202 comprising a plurality of segmented electrodes, a jig 203 for attaching the piezoelectric element 202 to a constant temperature bath 117, a reflector 223 that reflects the ultrasonic waves transmitted through the reaction container 114 or the like toward the reaction container 114 (see para [0029] et seq. in applicant’s corresponding US published 2024/0402200, hereinafter ‘200), or structural equivalents thereof; and
ii. “impedance measuring unit” as recited in the claims has been interpreted as including the components shown in Fig. 3, detection resistor 305, an operation amplifier 306, a logarithmic amplifier 307, micro control unit (hereinafter, abbreviated as “MCU”) 310, wiring 308 and 309, and when the MCU 310 including an A/D converter with a higher resolution is adopted, a linear amplifier may also be used instead of the logarithmic amplifier (see para [0039] et seq. of ‘200) or structural equivalents thereof.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f), 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) applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f): (1) 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).
Note: the claimed “control unit” in claims 9-12 has been interpreted by the examiner as a computer or equivalents thereof. That is, the “control unit” has been interpreted in the context of the underlying specification and field of the art (see MPEP 2111.01). Looking to applicant’s specification, the “control unit” has been defined as a computer or structural equivalents thereof rather than a mechanical type of control unit (e.g., switch). This interpretation is consistent with applicant’s specification which states “…the automatic analyzer further includes a control unit (host computer) that is configured by an electronic circuit or a storage device, and the operation of each of the units and each of the mechanisms is controlled by the control unit”, (see para [0025] of ‘200). Thus, the claimed controller cannot be reasonably interpreted as a mechanical type controller, such as valve or a discrete electronic device (e.g., solenoid, transistor, etc.)
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.
Claims 9-12 remain 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.
Claims 9 and 12 now recite “wherein the control unit is configured to continue or terminate operation of the automatic analyzer based on whether a correct connection exists”. It is not clear from these claim what the recitation “a corrected connection exist” refers to. The scope of these claims now recite two alternative connection determinations (1) stirring unit and power amplifier, and/or (2) stirring unit and impedance measuring unit. Thus, a recitation of a “correct connection” is indefinite. Specifically, it is not clear whether operation is continued/terminated based on: (a) the first connection; (b) the second connection; (c) either connection; (d) both connections being correct; or (e) the particular connection that happened to be tested. Accordingly, the metes and bounds of the claimed control operation in claims 9 and 12 are unclear.
Claim Rejections - 35 USC § 101
The instant claims now appear to be patent eligible under 35 U.S.C. 101. Specifically, the instant amendments integrate the “determining step” into a practical application because the determination is based on electrode-specific electrical impedance measurements obtained from particular piezoelectrical stirring hardware in an automatic analyzer and is used to control the operation of said automatic analyzer.
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 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Suzuki et al. (JP 2007-040843, hereinafter "Suzuki"- already of record) in view of Tsuda (US 2010/0135352, hereinafter "Tsuda"- already of record).
Regarding claims 9 and 12, Suzuki teaches an automatic analyzer having a stirring unit for stirring a sample and reagent in a reaction container by irradiation with ultrasonic waves and an abnormality determination method for an automatic analyzer (see Suzuki, para [0021] et seq., and Figs. 1-2). Suzuki teaches a piezoelectric ultrasonic sound source and providing a plurality of electrodes on the same sound source (Suzuki, paras [0012], [0032]). In the embodiment of Fig. 5, Suzuki teaches a plurality of electrodes arranged in an array on sound source 207 and are individually selectable by electrode selecting means 501 (see para [0046] et seq. and Fig. 5), thereby teaching or suggesting a piezoelectric element having a plurality of segmented electrodes. Suzuki further teaches driver 208 for applying a driving voltage to the sound source and impedance measuring means 601, (Suzuki- para [0028] et seq. and Fig. 2). When the sound source includes the array electrodes, Suzuki teaches selecting an electrode to be measured and measuring the impedance of the selected electrode (Suzuki- para [0056] et seq. and Fig. 6). Suzuki teaches respective impedance characteristics associated with electrodes X, Y and Z (Suzuki- para [0055] et seq. and Fig. 6), and using measured impedance characteristics diagnostically to determine changes or deterioration of the sound source (Suzuki- para [0063] et seq.) Suzuki therefore teaches individually obtaining electrical impedance information associated with the respective segmented electrode paths of a piezoelectric ultrasonic stirring unit.
Suzuki does not expressly teach determining from the measured impedance a connection condition (correctly connected) between the ultrasonic stirring unit and its electrical driving (power amplifier) or measuring circuitry (impedance measuring unit).
In the related art of automatic analyzers employing sound-wave stirring elements associated with reaction vessels, Tsuda teaches an electrical power-transmitting circuitry, connecting terminals 21b and 4a, and a piezoelectric sound-wave-generating element 23 driven through the electrical connection (Tsuda, Figs. 1, 2 and 4, see description of elements 21, 21b, 4a and 23). Tsuda further teaches the ultrasonic stirrer detects breakage of a signal line or poor connection at a terminal portion based upon an electrical drive signal supplied from a power source. Tsuda therefore expressly recognizes detection of an abnormal electrical connection between the drive circuitry and the ultrasonic sound-wave-generating element as a known diagnostic function of an analyzer ultrasonic stirring system. It would have been obvious to one of ordinary skill in the art at the time the claimed invention was effectively filed to modify the impedance-based diagnostic arrangement of Suzuki to determine whether an electrical connection associated with the ultrasonic stirring unit is normal or abnormal, as taught by Tsuda. One of ordinary skill in the art would have been motivated to make the modification because Suzuki already measures the electrical characteristics of the individual electrode paths of the piezoelectric ultrasonic source and uses those measurements diagnostically, while Tsuda teaches, in the same field of automatic-analyzer ultrasonic stirring, that the electrical path supplying the sound-wave-generating element should be monitored to detect signal-line breakage and poor terminal connection. Applying Tsuda's known connection-fault diagnostic function to Suzuki's existing individual-electrode electrical impedance measurement would predictably permit the analyzer to determine whether an abnormal measured electrical condition resulted from an improper electrical connection associated with the stirring unit.
The modification would not change the principle of operation of Suzuki. Suzuki already includes a piezoelectric ultrasonic source, individually selectable electrode paths, drive circuitry, electrode-selection circuitry, impedance-measuring circuitry, and a controller capable of evaluating the measured electrical impedance. The modification would merely use the electrical impedance information already obtained by Suzuki for the additional known diagnostic purpose taught by Tsuda, determining the integrity of the electrical connection associated with the ultrasonic stirring element.
With respect to the plurality of stirring units, Tsuda teaches an automatic analyzer including a specimen stirrer 20, reagent stirrers 26 and 27, and determining stirrer 28 disposed relative to the reaction table, thereby expressly demonstrating the use of plural ultrasonic stirring units in an automatic analyzer (Tsuda, Figs. 1-2 and corresponding description). Thus, to the extent Suzuki employs a common movable stirring mechanism, it would have been obvious to provide a plurality of instances of Suzuki's known ultrasonic stirring mechanism in the analyzer in view of Tsuda's express use of multiple ultrasonic stirrers, thereby permitting the respective stirring functions to be performed at their respective analyzer locations without repositioning a common stirring mechanism. The applicant is advised that the Supreme Court has clarified that a claim can be proved obvious merely by showing that the combination of known elements was obvious to try. In this regard, the Supreme Court explained that “[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has a good reason to pursue the known options within his or her technical grasp.” An obviousness determination is not the result of a rigid formal disassociated from the consideration of the facts of the case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. Furthermore, the simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR Int’l v. Teleflex Inc., 127 Sup. Ct. 1727, 1742, 82, USPQ2d 1385, 1397 (2007), see MPEP 2143).
Regarding claim 10, Suzuki teaches obtaining the frequency characteristic of the impedance by varying frequency while driving the sound source at a constant voltage (Suzuki, see para [0057] et seq. and Fig. 6). Suzuki teaches that the impedance-frequency characteristics vary depending upon the location of the reflecting interface of reaction liquid and thereby teaches determining variations in electrical impedance from the measured impedance characteristics.
Regarding claim 11, Suzuki teaches evaluating measured impedance characteristics to make a diagnostic determination concerning the ultrasonic source (Suzuki, see para [0054] and Fig. 6), while Tsuda teaches the control unit outputs an alarm when the magnitude of variation is not derivable is present, and/or when the stirring unit where the magnitude of variation exceeds a prescribed value is present. Specifically, Tsuda teaches that the control unit 15 causes a display unit 18 to display a result of the analysis and warning information for announcing an abnormality of the stirrer as well as various information in accordance with a display command input through the input unit 17. The control unit 15 outputs information including the analysis result and the warning information by printing the information on a recording paper sheet or the like through an output unit 19 such as a printer. Furthermore, the control unit 15 controls the start or suspension of an analytical work based on the presence or absence of an abnormality of each of the stirrers determined by a determining unit 16 (impedance measuring unit 16), see Tsuda- para [0026] et seq.
It would have been obvious to one of ordinary skill in the art to configure the control unit to output an alarm when the magnitude of the impedance variation cannot be determined in the combination of Suzuki and Tsuda, since an inability to determine the expected impedance variation prevents completion of the intended diagnostic determination and indicates that the electrical/stirring condition cannot reliably be established. Providing an alarm upon such an indeterminate diagnostic result would predictably inform the operator that the automatic analyzer cannot complete the intended stirring-unit diagnostic determination and that corrective action may be required.
Response to Arguments
Applicant's arguments filed June 10, 2026 have been fully considered but they are not persuasive. Applicant argues that Tsuda does not expressly or inherently disclose the stirring unit includes a piezoelectric element that includes a plurality of segmented electrodes, as currently recited in claims 9 and 12. However, the examiner has modified the rejection to cite Suzuki for the a piezoelectric ultrasonic sound source and providing a plurality of electrodes on the same sound source (Suzuki, paras [0012], [0032]). In the embodiment of Fig. 5, Suzuki teaches a plurality of electrodes arranged in an array on sound source 207 and are individually selectable by electrode selecting means 501 (see para [0046] et seq. and Fig. 5), thereby teaching or suggesting a piezoelectric element having a plurality of segmented electrodes. Suzuki further teaches driver 208 for applying a driving voltage to the sound source and impedance measuring means 601, (Suzuki- para [0028] et seq. and Fig. 2). When the sound source includes the array electrodes, Suzuki teaches selecting an electrode to be measured and measuring the impedance of the selected electrode (Suzuki- para [0056] et seq. and Fig. 6). Suzuki teaches respective impedance characteristics associated with electrodes X, Y and Z (Suzuki- para [0055] et seq. and Fig. 6), and using measured impedance characteristics diagnostically to determine changes or deterioration of the sound source (Suzuki- para [0063] et seq.) Suzuki therefore teaches individually obtaining electrical impedance information associated with the respective segmented electrode paths of a piezoelectric ultrasonic stirring unit. Thus, applicant’s arguments with respect to Tsuda in this regard are considered moot.
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.
Pertinent Prior Art
The following prior art is hereby made of record. Although the prior art is relied upon, the examiner considers the listed prior art relevant to the applicant’s invention and may be relied upon in a future prior art rejection or as general background information related to applicant’s field of endeavor.
i. Beard et al., (US 2008/0255781) teach a piezoelectric transducer self-diagnostics using impedance measurements to determine open, short, missing, damaged, or normal electrical connections, with individual channel/transducer addressing.
ii. JP 62-73165 teaches an apparatus that diagnosis an automatic analyzer from the outside during the analytical operation of said analyzer, by connecting a transmitting interface for self-diagnosis to the control apparatus of the automatic analyzer and releasing the fundamental diagnostic function to an external diagnostic apparatus in a software manner. All of the operational processes of an automatic analyzer are programmed to be stored in a memory apparatus and a central processing unit to allow a mechanism control circuit and a mechanism group to move according to the program. A self-diagnostic communication interface is connected to enable the connection to an external diagnostic apparatus. When there is the diagnostic request from the external diagnostic apparatus and there is no self-diagnostic request, a load is burdened only for the time corresponding to a time required in the practice of diagnosis and a constant treatment time is consumed regardless a self-diagnosis is performed or not (see abstract); and
iii. WO 2021/256027 (already of record) which teaches an automatic chemical analysis apparatus that a plurality of split electrodes (211) provided on a surface of a piezoelectric element (201) and applied with voltage by a power amplifier (203), causing the piezoelectric element to generate sonic waves to be applied to a reactor vessel (107). A host computer and impedance measuring circuit applies voltage to the split electrode to measure the electrical impedance spectrum of the split electrode.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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 between 9:30am-7pm 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.\ 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/P. Kathryn Wright/Primary Examiner, Art Unit 1798
Prosecution Insights