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 January 20, 2026. The amendments therein have been 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 Any previous objection/ rejection not repeated herein has been withdrawn.
Applicant's arguments have been thoroughly reviewed but are deemed moot in view of the amendments, withdrawn rejections, and new and/or modified grounds for rejection, necessitated by the amendments, as discussed below.
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: “cleaner” and “detector”.
The rules of the PTO require that application claims must “conform to the invention as set forth in the remainder of the specification and the terms and phrases used in the claims must find clear support or antecedent basis in the description so that the meaning of the terms in the claims may be
ascertainable by reference to the description.” 37 CFR 1.75(d)(1).
As Applicant appreciates, the terminology of the original claims follows the nomenclature of the specification, but sometimes in amending the claims or in adding new claims, new terms are introduced that do not appear in the specification. The use of a confusing variety of terms for the same thing should not be permitted. New claims and amendments to the claims already in the application should be scrutinized not only for new matter but also for new terminology. While an applicant is not limited to the nomenclature used in the application as filed, he or she should make appropriate amendment of the specification whenever this nomenclature is departed from by amendment of the claims so as to have clear support or antecedent basis in the specification for the new terms appearing in the claims. This is necessary in order to insure certainty in construing the claims in the light of the specification. See 37 CFR 1.75, MPEP §608.01(i) and § 1302.01. Note that examiners are to ensure that the terms and phrases used in claims presented late in prosecution of the application find clear support or antecedent basis in the description so that the meaning of the terms in the claims may be ascertainable by reference to the description, see 37 CFR 1.75(d)(1).
The specification remains objected to because of the following informalities: the “Brief Description of the Drawings” section does not include separate references to Fig. 4a-d, which in the examiner’s experience, may (or may not) result in this case being returned to the examiner by the allowance department, should this case be found allowable in the future, and possibly impacting the issue date.
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:
“detector configured to measure the electrical impedance for an electrode” in claims 1, 3, and 7, which the examiner believes corresponds to the previously claimed “detection unit”, see para [0045] of applicant’s US 2025/0067588; hereinafter ‘588), which is confusing as it appears to be either a sensor, which contradicts the purpose of the invention as discussed further below or software in the controller to apply applicant’s Formula 1, see ‘588 para [0051] et seq.; and
“cleaner configured to clean the reaction vessel” now recited in claims 1 and 8, appears to correspond to the “cleaning portion configured to clean the reaction vessel”, disclosed in ’588 at para [0042].
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 1-13 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 specification does not support the change in the preamble of the claims to a general “system” or “method” in claims 8-13. This amendment broadens the claims to any system and method beyond use in a chemical analyzer and chemical method. Thus, the scope of the instant claims does not find support in the specification as filed. The instant amendments to the preamble in the claims are considered new matter.
The current scope of amended claims 1 and 8, does not find support in the specification as file. The scope to the detector can reasonably be interpreted to measure a single impedance from that same single electrode, which is used by controller to estimate a liquid level height in the reaction vessel based on an amount of change in the electrical impedance from a single electrode. This does not find support in the specification. This considered new matter.
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 1-13 remain 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.
As discussed above, the claim limitations “detector” and “cleaner” invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structures, materials, or acts for performing the entire claimed functions and to clearly link the structures, materials, or acts to the function. It is not clear what elements are included the newly claimed cleaner. It is not clear if this a brush, wash, etc. The scope of the claim cannot be determined. Also it is unclear if the “detector” is part of the controller (i.e., part of the controller software) or a structural element separate from the controller as implied by the claims.
Therefore, the claims are indefinite and rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
As discussed above, the claimed detector is configured to measure an electrical impedance for an electrode of the plurality electrodes in a state where the reaction vessel faces the piezoelectric element. The current scope of the claims only requires measuring a single electrical impedance from a single electrode. It is unclear how controller can then estimate a liquid level height in the reaction vessel based on the “amount of change of the electrical impedance” base on the single measured impedance of the single electrode. This is confusing and indefinite.
In addition, the controller now include steps in response to determining a presence of liquid in the reaction vessel based on the estimated liquid level height,
1. apply, using the piezoelectric element, ultrasonic waves to the reaction vessel to stir the liquid or cause the cleaner to clean the reaction vessel, and
in response to determining an absence of the liquid in the reaction vessel based on the liquid level height,
2. cause the cleaner to clean the reaction vessel.
It is important to note that the controller is configured to estimate a liquid level and determine the presence or absence of liquid in the reaction container and based on a single impedance measurement and control the ultrasonic stirring mechanism or the cleaner. However, the claimed controller is no recited as configured to control the ultrasonic stirring mechanism or the cleaner. Thus, it not clear how the controller would cause stirring or cleaning in the reaction vessel.
Also, the claims do not clearly link the estimated liquid height to determining a presence or absence of the liquid in the reaction action. The controller determines (without a threshold) based on an estimated liquid height whether or not to stir by applying ultrasonic waves (more than one wave) using an the change in the amount of impedance in a single electrode to then stir the liquid in the reaction vessel. It is not clear what happens if the estimated liquid level present in the reaction vessel is almost empty (i.e., which would include an estimated liquid level height, but possibly below the lowest electrode on the piezoelectric element). According to applicant’s specification see para [0010] of ‘588, absence of sufficient reaction vessel liquid corresponding to the liquid level of the piezoelectric element (which is the source of stirring using the ultrasonic waves from the electrodes), the piezoelectric element may be damaged by unintended ultrasonic waves reflected from a peripheral portion of a reaction vessel accommodating portion. In other words, the controller is configured to estimate the liquid level height in the reaction vessel based on an amount of change in a single electrical impedance from a single electrode measured by the detector. It is unclear how a liquid level height in the reaction vessel can be estimated by the controller “based on an amount of change in impedance” from a single impedance measurement of a single electrode since one measurement does not provide any change relative to time. Also it is not clear if the change in the impedance is even based on time.
In addition, if the controller estimates a presence of liquid in the reaction vessel, it is not clear how the cleaner is configured to clean a reaction vessel that contains reaction liquids therein. Similarly, with respect to the last controller step, it not clear how the cleaner cleans the reaction container in the absence of liquid in the vessel. Looking to applicant’s specification, the cleaning portion 16 merely disclosed as “cleaning the reaction vessel”, see paras [0003], [0005], [0042] [0044], [0078] of ‘588. At the very least, applicant’s specification should include elements that make up the claimed cleaner and how the cleaner is configured to clean vessels full of a reaction liquid and those empty of reaction liquid, as such a cleaner is not considered well-known in the automatic analyzer art. Also, applicant’s specification cites beginning at para [0010] of ‘588, PTL 1-4 that it is conventionally known in the art that when ultrasonic waves are repeatedly irradiated into the air (such as would happen in the case of an empty vessel), the piezoelectric element itself may be damaged due to heat generation of the piezoelectric element.
It is noted the disclosed improvement of the invention is to implement a stirring function, by using an ultrasonic element in a reaction solution based on estimating/determining the presence or absence of the reaction liquid (i.e. ,a liquid level height of the reaction liquid) without using a means such as a sensor and a visual inspection, see ‘588 para [0010]-[0028]. However, as best understood, this is exactly what the current claims recite but for claiming a “detector” instead of a “sensor”. Applicant admits that use of “sensor/detector” to measure an electrical impedance for an electrode is known in the prior art. Since the specification does not disclose how the claimed “detector” distinguishes from a prior art “sensor”, the examiner considers them structural equivalents as they both are configured to perform the same function in substantially the same way (measure the electrical impedance of an electrode). In other words, the claims are incapable performing the disclosed improvement of estimating presence or absence of a reaction liquid (liquid level height of the reaction liquid) without use of a sensor/detector.
Applicant is respectfully reminded MPEP 2106.04(a) details that the claims must reflect the disclosed improvement. Note specifically MPEP 2106.05(a), 4th paragraph recites the claim must include the components or steps of the invention that provide the improvement described in the specification. Beginning at page 9 of the “Remarks”, the applicant cites para [0028]-[0030] for support of embodiments that allow for estimating presence or absence of liquid (liquid level height in a reaction vessel) without a sensor or visual inspection, thereby automating performance of abnormality diagnosis of an ultrasonic stirring mechanism. However, claimed the techniques do not provide any technical improvement as argued since the instant claims require a sensor (detector) which provides measurement upon which the controller uses to estimate the liquid level and hence, the presence or absence of liquid in a vessel. Thus, the claims do not include elements (or lack thereof) that achieve the improvement as described in the specification or argument that would be capable of estimating presence or absence of liquid without a sensor. It is important to note that the examiner recognizes that the claims do not need to explicitly recite the improvement; the key is that the claims include elements that achieve the improvement described in the specification. In this case the claim require a sensor/detector just like the known prior art, and therefore, cannot achieve the improvement over the known prior art as described in the specification.
Claims 2-7 and 9-13 are confusing and do not clarify how the controller estimates and performs failure diagnosis of the piezoelectric element based on a relationship set in advance between the electrical impedance and the liquid level height. It appears that some specific diagnosis algorithm or determination standard are not specified in the claims, and the means for executing the diagnosis is unclear; therefore, the scope of the claims are unclear. Looking to the specification, the specification recites that "a failure is determined by comparison with the amount of change in the electrical impedance of a nearby segment" (see, in particular, para [0075]), and that "when the estimated value of the liquid level height is significantly different from that of the surrounding (nearby) segment, a failure of the corresponding segment is diagnosed" (see, in particular, para [0076]). In view of the specification, it is recognized that the comparison of the measurement results of the electrical impedance between the surrounding (nearby) segments would be necessary to diagnose a failure of the piezoelectric element. Therefore, it is not clear how the analysis unit can use a preset relationship to determine a failure diagnosis.
Claims 5 and 11 now recite the step of determining that the amount of change in the electrical impedance is greater than a “normal state” to determine failure of the piezoelectric element. The term “normal ” is a relative term which renders the claim indefinite. The term “normal” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The claims have not defined what amount of change applicant considers a normal state, and how that is used to determine the failure of the piezoelectric element. This is confusing and indefinite.
Claims 6 and 12 recite a frequency of the voltage to be applied (which does not require actually voltage to be applied) from the power supply to the (single electrode) be swept and the (single) electrical impedance is measured by integrating the electrical impedances (from somewhere) in a measurement range of the swept frequency. Note: that the parent claims 1 and 8 do not require any previous determination or storage of “electrical impedances” in a measurement range of the swept frequency. The measurement of the electrical impedance has already been performed in the parent claims. Also, these steps are not performed by the controller, thus, it unclear how much patentable weight these steps should receive.
Claims 7 and 13 recite “a reference electrical impedance is measured in advance when there is no liquid in the reaction vessel is used as a reference value”. It is not clear from the claim what period of time applicant considers “in advance” and the measurement of the empty vessel is not required. Also, the phrase “is used as a reference value” is confusing. It is not clear to what reference value applicant is referring. It is not clear from the claim how the single electrical impedance from a single electrode (already measured by the detector in the parent claims) is then again measured by integrating a difference between the electrical impedance measured by the detector (which electrical impedance?) and the reference electrode impedance. It is not clear where the “reference electrode” is located relative to the reaction vessel, cleaner, piezoelectric element, other plurality of electrodes, power supply and detector.
The instant claims are confusing and indefinite.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-13, as best understood, remain rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The instant rejection reflects the Guidance published in the Federal Register notice titled 2019 Revised Patent Subject Matter Eligibility Guidelines (Vol. 84, No. 4, Monday January 7, 2019 at 50) and the October 2019 Updated Subject Matter Eligibility Guidance (hereinafter both referred to as the “Guidance”).
Framework with which to Evaluate Subject Matter Eligibility:
(1) Are the claims directed to a process, machine, manufacture or composition of matter;
(2A) Are the claims directed to a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea (Prong One); If the claims are directed to a judicial exception under Prong One, then is the judicial exception integrated into a practical application (Prong Two); and
(2B) If the claims are directed to a judicial exception and do not integrate the judicial exception, do the claims provide an inventive concept.
Framework Analysis as Pertains to the Instant Claims:
With regard to (1), the instant claims recite “a chemical analysis apparatus” (claim 1) and method (claim 8), and therefore the answer is "yes".
With regard to (2A), Prong One, under the broadest reasonable interpretation (BRI), the instant claims recite claim steps directed to the judicial exception that is an abstract idea of the type that is in the grouping of “mental process” (See MPEP 2106.04(a)(2) subsections (I) and (III)) because said operations could be performed in the mind, but for the recitation of an analysis unit. Mental operations in the instant claims are recited as: estimating the liquid level height in the reaction vessel based on an amount of change in the electrical impedance measured by the detection unit. The step of estimating of the liquid level in the reaction vessel based on the amount of change in the electrical impedances measured by the detection unit encompasses math as it can be done by a calculation (see for example; formula for Esw, which is calculated by integrating, in a measured frequency range of the ultrasonic waves (from a frequency f1 to a frequency f2), a difference between measurement results of the electrical impedance at different reaction liquid amounts (see para [0039] et seq.) The estimation of the liquid level height based on the measurement from a single electrical impedance is math (see para [0047] et seq.) In summary, the claim(s) recite(s) a system and method for detecting and estimating the liquid level height which is a step that can be performed mentally as a form of an abstract idea. Specifically, a user or laboratory technician could easily, in their mind, estimate the liquid level of the mixture in the vessel as it encompasses math and can be done by a calculation based a detection unit that measures the electrical impedance in a state where a reaction vessel containing a mixture, wherein the mixture faces the piezoelectric element, and calculate an estimate of the liquid level height based on a calculation. In fact, claims 7 and 13 do not appear to require any actual detection but merely a comparison with previously established liquid calibration curve.
Said recited judicial exception steps are directed to measuring an electrical impedance for each of the plurality of electrodes or for any combination of the electrodes. A claim, under its BRI, which covers performance of the limitation in the mind, but for the recitation of generic computer elements, falls within the “mental processes” grouping of abstract ideas (see MPEP 2106.04(a)(2)(III)(C)). MPEP in 2106.04(a)(2)III says: “The courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid (e.g., pen and paper or a slide rule) to perform the claim limitation.”, and also says “[n]or do the courts distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer.” Applicants implicitly rely on a computer (analysis unit) as a tool to perform the abstract idea MPEP 21604(a)(2) III C. In this case, the claims are directed towards detecting electrical impedance for a plurality of electrodes and calculating/estimating a liquid level in the container, and the processes can be done as a mental process with pencil and paper (or a computer).
Because the claims are directed to abstract ideas, they must further be analyzed under Prong Two to determine if said judicial exceptions are integrated into a practical application as determined by further assessment of the “additional steps” recited in the claims. With respect to Prong Two, the additional elements and the rationale pertaining to why the additional elements are not integrated, are as follows:
(a) the claims recite mental steps (judicial exception) which are not integrated into a practical application because the apparatus and method describes measuring electrical impedance a single electrodes and estimating the liquid level height of the reaction vessel as a general mental concept/process, but the system does not describe a resultant action/step that is taken by applying the calculations, and therefore the method does not add a meaningful limitation to the abstract idea. Nor is the estimated liquid level applied in any application much less a practical application, since the disclosed improvement of the invention is estimating presence or absence of a reaction liquid and a liquid level height of the reaction liquid without using a means such as a sensor/detector or a visual inspection, ‘588 para [0010]-[0028]. However, as best understood, this is exactly what the current claims recite but for the nominal change of the word “sensor” which the applicant admits is known in the prior art, to a “detector”. Since the specification does not disclose how the claimed “detector” distinguishes from the prior art “sensor”, the examiner considers them as structural equivalents. That is both perform the same function in substantially the same way to measure the electrical impedance of an electrode. In other words, the claims are incapable performing the disclosed improvement of estimating presence or absence of a reaction liquid and a liquid level height of the reaction liquid without using a detector. Thus, new control steps of determining and applying do not provide for the stated improvement of the instant claims into any practical application.
Furthermore, claims 4 and 10 appear to estimate the liquid level height in the reaction vessel based on a relationship set in advance between the electrical impedance and the liquid level height, which is further evidence that this estimation is merely a mathematical calculation and nothing more.
(b) although the claims recite a reaction vessel, cleaner configured to clean the reaction vessel, an ultrasonic stirring mechanism including a piezoelectric element that includes a plurality of electrodes and a detector configured to measure an electrical impedance for an electrode, the claims do not apply the exception, as the claim does not transform the chemical analysis apparatus to a different state or thing beyond its ordinary purpose because the system and method is used only to stir or clean, as pointed out in the rejection Toshiyuki, cited in applicant’s specification as PTL-3 (See MPEP 2106.05(f) and MPEP 2106.05(c));
(c) the “detector” and “controller” are recited at a high level of generality such that it is no more than mere instructions to apply the exception using a generic chemical analysis apparatus/method and computer/processor (see MPEP 2106.04(a)(2)(III)(C) and MPEP 2106.05(d));
As such, the additional elements do not integrate the abstract idea into a practical application because they do not impose meaningful limits on practicing the abstract idea.
Because the claims fail under (2A), the claims are further evaluated under (2B). The claims herein do not include additional elements that are sufficient to amount to significantly more than the judicial exception under (2B) because, as discussed above with regard to integration of the recited abstract idea into a practical application, the additional elements herein amount to no more than a chemical analysis apparatus that includes generic computer elements (controller), which do not provide an inventive concept as a generic automated analysis apparatus with a computer/processor is well-understood, routine and conventional. Further, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because (1) the cleaner, reaction vessel, piezoelectric element, electrodes, detector, and power supply are being used in their ordinary capacity and are merely tools to execute the abstract idea (See MPEP 2106.05(d)), (2) the additional claim elements detecting the liquid level height encompasses math as it can be done by a calculation (calculation is based on sensed electrical impedance as discussed in para [0039] et seq., of specification and the formula shown). The calculating an liquid level height in the reaction vessel is math, thus, whether considered individually or as a whole, do not meaningfully limit the judicial exception (See MPEP 2106.05(e)), (3) the claims recite insignificant extra-solution activity because the activity of using a reaction vessel, cleaner, a piezoelectric element, electrodes, detector, and power supply to gather data and somehow determine and apply this data to prevent damage to the piezoelectric element by heat generation by repeatedly generating ultrasonic waves in the air (Tech-Problem section of Toshiyuki (cited as known prior art at para [0010] of ‘588). Thus additional structural elements are well-known and conventional and would not provide practical application (See MPEP 2106.05(g)).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the features represent an abstract idea. Dependent claims 2-7 and 9-13, as best understood, amount to no more than performing more calculations of the liquid level height in the reaction vessel, and comparing information, which is an intangible abstract idea, and similarly does not integrate the exception into a practical application or include additional elements that amount to significantly more. The instant claims do not reflect the disclosed improvement over the prior art.
Additionally, see MPEP 2106.04(a)(2)(III)(C) which states that methods of performing a mental process on a generic computer, performing a mental process in a computer environment, or using a computer as a tool to perform a mental process are all claims that recite a mental process. Specifically, because the method claims are directed to determining information, and then comparing information, the steps are directed towards using an implied computer/processor as a tool to determine, compare, estimate information together to apply stirring and/or cleaning the reaction vessel which is full or empty of reaction liquid. Further, because the claims recite the generic use of a computer, the claimed determining and linking information is an action that humans could have performed amongst themselves (or in their own mind).
Thus, in light of the above considerations the claims remain non-statutory, and are thus not patent eligible under 35 U.S.C. 101.
Prior art
Note that 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. As stated in In re Steele, 305 F.2d 859, 134 USPQ 292 (CCPA 1962), a rejection under 35 U.S.C. 103 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 has attempted to apply the closest prior art with respect to the claims 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 1-5, 7-11, and 13, as best understood, are rejected under 35 U.S.C. 103 as being unpatentable over Toshiyuki (JP 2010-96638; hereinafter “Toshiyuki”-already of record) in view of Katahira et al., (JP 11-352131; hereinafter “Katahira”).
As to claims 1 and 8, Toshiyuki teaches a chemical analysis apparatus and method of operating the same comprising:
a reaction vessel 6 to receive two or more different liquid amounts (interpreted as able to receive different liquid amounts);
a cleaner (washing unit 16) configured to clean the reaction vessel; and
an ultrasonic stirring mechanism comprising;
a piezoelectric element 4,
a plurality of electrodes 5 arranged on the piezoelectric element,
a power supply unit 2 configured to apply a voltage to each of the electrodes, and
a detector 9 configured to measure an electrical impedance for an electrode of the plurality of electrodes in the state where the reaction vessel faces the piezoelectric element 4 (see Fig. 1), and
a controller 1 configured to estimate the liquid level height in the reaction vessel based on an amount of change in the electrical impedance measured by the detector for an electrode (specifically, as shown in FIG. 3B, the resonance frequency 24 of the frequency characteristic 23 of the impedance of the piezoelectric element 4 in a state where the reaction vessel 6, the reaction liquid 7, and the sound wave propagation medium 8 are normal, or a sine wave in the vicinity thereof, or the resonance frequency. The piezoelectric element 4 is driven by a voltage. The applied voltage waveform or current waveform at this time is measured by the detector 9 and stored in the recording unit 10. Alternatively, the impedance in the state of FIG. 3B is previously incorporated as a circuit constant of the detector 9. Thereafter, the impedance of the piezoelectric element 4 is measured by a measuring method before stirring, and when the impedance difference exceeds a predetermined value, the detection unit 9 determines that there is an abnormality and outputs a sound wave to the stirring control unit 1and issue a stop signal). Furthermore, Toshiyuki teaches the stirrer 14 measures the electrical impedance of the piezoelectric element by applying a voltage to the piezoelectric element before stirring after the reaction vessel 6 to be stirred stops at the stirring position 22. From the results, the presence of the reaction vessel and the reaction liquid, the presence / absence of a medium (liquid) that transmits sound waves, and the presence / absence of temperature abnormality are detected. At this time, the voltage applied to the piezoelectric element is set to a lower voltage than when a sound wave is output, thereby preventing deterioration of the piezoelectric element due to an unintended reflected wave at the time of abnormality. Further, when an abnormality is detected from the detection result, output of sound waves is stopped. In other words, like the instant invention, Toshiyuki teaches that a sensor/detector is configured to monitor the surroundings of the piezoelectric element and thus the sensor/detector is not provided separately from the piezoelectric element, (i.e., separate dedicated sensor/detector is not needed and the sensor/detector in Toshiyuki is a component of the ultrasonic stirring mechanism) using the piezoelectric element itself as a sound source and as a sensor, sound waves are generated from the piezoelectric element without complicating the configuration. Toshiyuki teaches the presence or absence of a reaction vessel and reaction solution can be confirmed. Further, it is possible to detect a change in the electrical impedance emitted from at least one electrode of the piezoelectric element.
Toshiyuki teaches, as shown in FIG. 2, the automatic analyzer includes a cleaning unit 16 controlled by the control unit 1. However, Toshiyuki does not explicitly disclose that the controller determines a presence or absence of liquid in the reaction vessel based on the estimated liquid level height to cause the cleaner to clean the reaction vessel. However, in the related automatic analyzer art, Katahira teaches after detecting the liquid level in a reaction vessel is filled or empty using the detector shown in FIG. 5, the reaction container is positioned at the cleaning position, and the liquid is detected again immediately before the cleaning in the reaction container cleaning section, so that more reliable liquid detection can be performed, (see para [0070] et seq.)
Accordingly, it would have been obvious to one of ordinary skill in the art at the time the claimed invention was effectively filed to have included in analyzer system and method of the control steps in Toshiyuki, the step of detecting whether or not the reaction was full or empty before washing, like that taught in Katahira, for the expected benefit determining how much washing liquid should be introduced to the vessel based the liquid level in order to avoid wasting by possibly using more washing liquid than needed to clean the vessel.
As to claims 2 and 9, modified Toshiyuki teaches the plurality of electrodes are arranged in a height direction of the reaction vessel 6 when the reaction vessel is mounted to the ultrasonic stirring mechanism (see Fig. 1).
As to claim 3, modified Toshiyuki teaches an electrode selector 3 connected between the power supply unit and the electrodes, wherein the voltage is applied from the power supply to the electrode selected by the electrode selector, and the detector measures the electrical impedance for the electrode selected by the electrode selector (specifically, Toshiyuki teaches by measuring the electrical impedance of the piezoelectric element 4 at the resonance frequency 24 in the state of FIG. 3B and the voltage in the vicinity thereof, the presence or absence of the reaction vessel 6 or the presence or absence of the reaction liquid 7, Furthermore, the conditions around the piezoelectric element, such as the presence or absence of a liquid serving as the sound wave propagation medium 8, are estimated, and the output of sound waves can be stopped when an abnormality is detected). The presence or absence of the reaction liquid corresponds to the liquid level height in the reaction vessel.
As to claims 4 and 10, modified Toshiyuki teaches the controller that estimates the liquid level height in the reaction vessel based on a relationship set in advance between the electrical impedance and the liquid level height (specifically, Toshiyuki discloses the impedance in the state of FIG. 3B is previously incorporated as a circuit constant of the detection unit 9. Thereafter, the impedance of the piezoelectric element 4 is measured by the above measuring method before stirring (i.e., based on previously stored relationship between impedance and liquid level height stored in memory 10), and when the impedance difference exceeds a predetermined value, the detection unit 9 determines that there is an abnormality and outputs a sound wave to the stirring control unit 1. Issue a stop signal).
As to claim 5 and 11, modified Toshiyuki discloses the controller performs failure diagnosis of the piezoelectric element based on a relationship set in advance between the electrical impedance and the liquid level height (Toshiyuki discloses the detection unit 9 determines that there is an abnormality and outputs a sound wave to the stirring control unit 1 and issues a stop signal).
As to claims 7, and 13, modified Toshiyuki discloses the electrical impedance measured in advance when there is no liquid in the reaction vessel is used as a reference value, and the electrical impedance is measured by integrating a difference between the electrical impedance measured by the detection unit and the reference value, (specifically, Toshiyuki discloses the impedance in the state of FIG. 3B is previously incorporated as a circuit constant of the detection unit 9. Thereafter, the impedance of the piezoelectric element 4 is measured by the above measuring method before stirring (i.e., based on previously stored relationship between impedance and liquid level height stored in memory 10), and when the impedance difference exceeds a predetermined value, the detection unit 9 determines that there is an abnormality and outputs a sound wave to the stirring control unit 1 to issue a stop signal).
Claims 6 and 12, as best understood, are rejected under 35 U.S.C. 103 as being unpatentable over Toshiyuki and Katahira, as applied to claims 1 and 7, in further view of Yoichiro et al., (JP 2003-254979; hereinafter “Yoichiro”-already of record).
Toshiyuki and Katahira do not specifically recite a frequency of the voltage to be applied from the power supply to the electrode is swept, and the electrical impedance is measured by integrating the electrical impedances in a measurement range of the swept frequency.
Yoichiro teaches a chemical analysis apparatus and method of operating the same comprising:
an ultrasonic stirring mechanism which includes
a piezoelectric element 110,
a plurality of electrodes arranged on the piezoelectric element (Yoichiro is provided with a plurality of electrodes on one piezoelectric material, and at the same time, a water leakage detection electrode 203 and an applied waveform detection electrode 202 are provided, see Fig. 2),
a power supply unit 120 configured to apply a voltage to each of the electrodes,
a detection unit 204 configured to measure an electrical impedance for each of the plurality of electrodes or for any combination of the electrodes, and
an controller 120 configured to determine a liquid level height in a reaction vessel based on the electrical impedance detected by the detection unit, and
the controller estimates the liquid level height in the reaction vessel based on an amount of change in the electrical impedance measured by the detection unit (specifically, the piezoelectric element selection unit 201 controls the control unit 10 to select the electrode at the height to be irradiated with the ultrasonic wave 111 depending on the liquid amount (i.e., liquid level).
Yoichiro teaches a frequency of the voltage to be applied from the power supply to the electrode is swept, and the electrical impedance is measured by integrating the electrical impedances in a measurement range of the swept frequency (specifically, Yoichiro teaches 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). Accordingly, it would have been obvious to one of ordinary skill in the art at the time the claimed invention was effectively filed to have included in Toshiyuki and Katahira, the providing the applied waveform detecting section taught by Yoichiro since Yoichiro teaches that this configuration can detect the insufficient strength of the generated ultrasonic waves due to deterioration of the ultrasonic source, the presence / absence of ultrasonic output when unnecessary, and the quality of the stirring state. The reliability of the automatic analyzer can be improved.
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 arguments filed January 30, 2026 have been fully considered but they are not persuasive.
Respectfully, it is noted that applicant did not explain how the previous or amended claims avoid or distinguish from the previous 35 U.S.C. 102(a)(1) rejection over Toshiyuki, beginning at item #13 of the previous Official action. Applicant’s arguments with respect to claims have been considered but are moot because the new prior art ground of rejection does not rely on any reference specifically challenged in the applicant’s arguments. In addition, the previous arguments with respect to the 35 USC 112 (b) and 101 have been address above.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure include:
Kourai et al., (US 2021/0270707), which teach a chemical analysis device is provided with: a plurality of ultrasonic elements; a waveform generator which generates an ultrasonic waveform; a determiner which determines the positions and the number of ultrasonic elements to be driven from among the plurality of ultrasonic elements; a variable matching circuit which, on the basis of the determination result, matches impedance between the waveform generator and each of the ultrasonic elements to be driven; and a switch which selects the ultrasonic elements to be driven from among the plurality of the ultrasonic elements.
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.
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/P. Kathryn Wright/Primary Examiner, Art Unit 1798
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