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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 1 is objected to because of the following informalities: in line 2, “the device” should read “the electrolyte analysis device”. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: in line 2, “the specimen” should read “the specimen solution”. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: in lines 2-3, “the specimen” should read “the specimen solution”. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: in line 5, “ions” should read “ion”. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: in line 1, “the solution” should read “the specimen solution”. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: in line 2, “the specimen” should read “the specimen solution”. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: in lines 5-6, “the ion-selective electrodes” should read “the N ion-selective electrodes”. Appropriate correction is required.
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: “storage unit” in claim 1, “interfering ion analysis unit” in claims 1-4 and 6, “output unit” in claim 12, and “input unit” in claims 13-14. There is no corresponding structure in the instant specification for these limitations.
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 claims recite the limitations “storage unit” in claim 1, “interfering ion analysis unit” in claims 1-4 and 6, “output unit” in claim 12, and “input unit” in claims 13-14 which 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 structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The disclosure is devoid of any structure that performs the function in the claim. Therefore, these means-plus-function limitations lack adequate written description. MPEP § 2181(IV). Claims 2-15 are rejected as dependent thereon.
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.
Claim limitations “storage unit” in claim 1, “interfering ion analysis unit” in claims 1-4 and 6, “output unit” in claim 12, and “input unit” in claims 13-14 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 structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The disclosure is devoid of any structure that performs the function in the claim. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Claims 2-15 are rejected as dependent thereon.
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.
The term “high-density” in claim 8 is a relative term which renders the claim indefinite. The term “high-density fixed charges” 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. Although the specification discloses at para. [0112] of the instant US PGPub that a membrane having high-density fixed charges has high concentrations of cations and counter anions, “high concentration” is also a relative term and the specification has not provided a standard for ascertaining the requisite degree. Although the specification also discloses at para. [0133] of the instant US PGPub that a person skilled in the art can determine whether a membrane having high-density fixed charges is used as the sensitive membrane based on the type of membrane, there is still no standard for ascertaining the requisite degree of “high-density” and therefore the scope of the invention is indefinite.
The term “high concentration” in claim 10 is a relative term which renders the claim indefinite. The term “high concentration” 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. Although the specification discloses at para. [0132] of the instant US PGPub that the standard of “high concentration” may be an upper limit or a higher value of the concentration range of the ions to be measured that is usually assumed to be contained in the specimen or that can be measured by the electrolyte concentration measurement device, the specification does not further disclose the concentration range of the ions to be measured that is usually assumed to be contained in the specimen or that can be measured by the electrolyte concentration measurement device, so there is still no standard for ascertaining the requisite degree of “high concentration” and therefore the scope of the invention is 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 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 1 recites detecting an influence of the interfering ion in a specimen solution based on the potential change over time.
The limitation of detecting an influence of the interfering ion in a specimen solution based on the potential change over time, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind. Nothing in the claim precludes the limitations from practically being performed in the mind. The “detect” and “based on” language in the context of the claim encompasses the user mentally determining an influence of the interfering ion based on the obtained potential change over time. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim recites the additional elements of: an electrolyte analysis device comprising an ion-selective electrode, a storage unit, and an interfering ion analysis unit. These elements are recited at a high-level of generality such that they amount to no more than mere data gathering elements linked to the judicial exception. Accordingly, these additional elements do not integrate the abstract ideas into a practical application because they do not impose any meaningful limits on practicing the abstract ideas as they are insignificant extra-solution activity. MPEP § 2106.05(g). The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of an electrolyte analysis device comprising an ion-selective electrode, a storage unit, and an interfering ion analysis unit amount to no more than mere data gathering elements in conjunction with the judicial exception. Mere data gathering steps and insignificant extra-solution activity linked to the judicial exception cannot provide an inventive concept, particularly when the activity is well-understood or conventional. Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978). See MPEP § 2106.05(g). For example: Kishioka et al. (JP 2020041968 A) (references herein made with respect to US equivalent US 2021/0318266 A1) teaches an electrolyte concentration measurement device 10 comprising an ion-selective electrode 101, a data storage unit 184, and a potential response curve analysis unit 183 (Fig. 1, para. [0027]-[0028], [0036]). The claims do not invoke any of the considerations that courts have identified as provided significantly more than an exception. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, claim 1 as a whole does not amount to significantly more than the exception itself. The claims are not patent eligible.
Claims 2-15 are rejected under 35 U.S.C. 101 as dependent thereon and also do not include additional elements that are sufficient to amount to significantly more or integrate the exception into a practical application. Appropriate correction is requested.
Claims 2-3 and 6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 2 recites identifying a type of the interfering ion in the specimen based on a direction of a change in a potential waveform. Claim 3 recites calculating a concentration of the interfering ion in the specimen based on a slope of a change in a potential waveform. Claim 6 recites comparing a potential waveform of the ion-selective electrode with a potential waveform of an electrode that responds to an ion having an opposite electric charge to an electric charge of an ion to be measured.
The limitations of identifying a type of the interfering ion in the specimen based on a direction of a change in a potential waveform, calculating a concentration of the interfering ion in the specimen based on a slope of a change in a potential waveform, and comparing a potential waveform of the ion-selective electrode with a potential waveform of an electrode that responds to an ion having an opposite electric charge to an electric charge of an ion to be measured, as drafted, are processes that, under its broadest reasonable interpretation, cover performance of the limitations in the mind. Nothing in the claim precludes the limitations from practically being performed in the mind. The “identify,” “calculate,” “based on,” and “compare” language in the context of the claims encompass the user mentally identifying the type of interfering ion based on a direction of change in a potential waveform, calculating a concentration of the interfering ion based on a slope of a change in a potential waveform, and comparing potential waveforms. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea. The limitation of calculating a concentration of the interfering ion in the specimen based on a slope of a change in a potential waveform, as drafted, is a process that, under its broadest reasonable interpretation, covers mathematical concepts such as mathematical calculations and equations. The “calculating” and “slope” language in the context of the claim encompasses mathematical calculations that can be performed by a user. If a claim limitation, under its broadest reasonable interpretation, covers mathematical calculations, then it falls within the “Mathematical Concepts” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of the interfering ion analysis unit and the ion-selective electrode. These elements are recited at a high-level of generality such that they amount to no more than mere data gathering elements linked to the judicial exception. Accordingly, these additional elements do not integrate the abstract ideas into a practical application because they do not impose any meaningful limits on practicing the abstract ideas as they are insignificant extra-solution activity. MPEP § 2106.05(g). The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of the interfering ion analysis unit and the ion-selective electrode amount to no more than mere data gathering elements in conjunction with the judicial exception. Mere data gathering steps and insignificant extra-solution activity linked to the judicial exception cannot provide an inventive concept, particularly when the activity is well-understood or conventional. Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978). See MPEP § 2106.05(g). For example: Kishioka et al. (JP 2020041968 A) (references herein made with respect to US equivalent US 2021/0318266 A1) teaches the ion-selective electrode 101 and the potential response curve analysis unit 183 (Fig. 1, para. [0028], [0036]). The claims do not invoke any of the considerations that courts have identified as provided significantly more than an exception. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, claims 2-3 and 6 as a whole do not amount to significantly more than the exception itself. The claims are not patent eligible.
Claim 4 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 4 recites calculating a concentration of an ion to be measured, correcting the influence, and calculating the concentration of the ion to be measured based on the influence.
The limitations of calculating a concentration of an ion to be measured, correcting the influence, and calculating the concentration of the ion to be measured based on the influence, as drafted, are processes that, under its broadest reasonable interpretation, cover performance of the limitations in the mind or performing the calculations with pen and paper. Nothing in the claim precludes the limitations from practically being performed in the mind or with pen and paper. The courts consider a mental process that can be performed by a human using a pen and paper to be an abstract idea. See MPEP § 2106.04(a)(2)(III). The “calculate,” “correct,” and “based on” language in the context of the claims encompass the user mentally calculating a concentration of an ion to be measured, correcting the influence, and calculating the concentration of the ion to be measured based on the influence. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea. The limitations of calculating a concentration of an ion to be measured and calculating the concentration of the ion to be measured based on the influence, as drafted, are processes that, under its broadest reasonable interpretation, cover mathematical concepts such as mathematical calculations and equations. The “calculating” language in the context of the claim encompasses mathematical calculations that can be performed by a user. If a claim limitation, under its broadest reasonable interpretation, covers mathematical calculations, then it falls within the “Mathematical Concepts” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim recites the additional elements of a concentration calculation unit and the interfering ion analysis unit. These elements are recited at a high-level of generality such that they amount to no more than mere data gathering elements linked to the judicial exception. Accordingly, these additional elements do not integrate the abstract ideas into a practical application because they do not impose any meaningful limits on practicing the abstract ideas as they are insignificant extra-solution activity. MPEP § 2106.05(g). The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of a concentration calculation unit and the interfering ion analysis unit amount to no more than mere data gathering elements in conjunction with the judicial exception. Mere data gathering steps and insignificant extra-solution activity linked to the judicial exception cannot provide an inventive concept, particularly when the activity is well-understood or conventional. Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978). See MPEP § 2106.05(g). For example: Kishioka et al. (JP 2020041968 A) (references herein made with respect to US equivalent US 2021/0318266 A1) teaches a concentration calculation unit 172 and the potential response curve analysis unit 183 (Fig. 1, para. [0036]). The claims do not invoke any of the considerations that courts have identified as provided significantly more than an exception. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole do not amount to significantly more than the exception itself. The claims are not patent eligible.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3 and 5-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kishioka et al. (JP 2020041968 A) (references herein made with respect to US equivalent US 2021/0318266 A1).
Regarding claim 1, Kishioka teaches an electrolyte analysis device having an ion-selective electrode and using potential measurement (an electrolyte concentration measurement device 10 comprising an ion-selective electrode 101 and using potential measurement, Fig. 1, para. [0027]-[0028]), the device comprising:
a storage unit configured to store a relationship of a potential change over time with respect to an interfering ion (a data storage unit 184 for storing library data related to the feature value of the potential response curve which is a transient change in the potential of the ion-selective electrode 101, Fig. 1, para. [0036], [0095]-[0096]; a potential response curve may include an aqueous solution containing interfering ions, Fig. 6, para. [0103]); and
an interfering ion analysis unit configured to detect an influence of the interfering ion in a specimen solution based on the potential change over time obtained from the ion-selective electrode while the specimen solution is stationary after the specimen solution comes in contact with the ion-selective electrode (a potential response curve analysis unit 183 that analyzes the potential response curve generated by a potential monitoring unit 181, the potential response curve being a transient change in the potential of the ion-selective electrode 101 after introduction of the liquid into the flow path of the ion-selective electrode 101, Fig. 1, para. [0036], [0038]-[0039], [0095], [0097]; the potential response curve analysis unit 183 determines contamination of a surface of the ion-selective electrode 101 based on a waveform of the potential response curve at the time of stopping movement of the liquid in the flow path of the ion-selective electrode 101, Fig. 1, para. [0039], [0095], [0097], the liquid including an ion solution containing interfering ions, Fig. 6, para. [0093], [0103]).
The limitations “using potential measurement,” “store a relationship of a potential change over time with respect to an interfering ion,” and “detect an influence of the interfering ion in a specimen solution based on the potential change over time obtained from the ion-selective electrode while the specimen solution is stationary after the specimen solution comes in contact with the ion-selective electrode” are interpreted as intended use and/or functional language. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP § 2114. The electrolyte concentration measurement device disclosed by Kishioka teaches all of the structural limitations of the claim and thus is configured for and capable of the intended use and/or functional language in the claim.
Examiner further notes that Kishioka teaches that the electrolyte concentration measurement device 10 is configured to measure a potential difference between electrodes (Fig. 1, para. [0027]), so the electrolyte concentration measurement device 10 is capable of the recitation “using potential measurement.” Kishioka also teaches that the data storage unit 184 stores library data related to the feature value of the potential response curve which is a transient change in the potential of the ion-selective electrode 101 (Fig. 1, para. [0036], [0038], [0095]-[0096]), and a potential response curve may include an aqueous solution containing interfering ions (Fig. 6, para. [0103]), so the data storage unit 184 is capable of the recitation “store a relationship of a potential change over time with respect to an interfering ion.” Kishioka also teaches that the potential response curve analysis unit 183 analyzes the potential response curve generated by a potential monitoring unit 181 after introduction of the liquid into the flow path of the ion-selective electrode 101 and determines contamination of a surface of the ion-selective electrode 101 based on a waveform of the potential response curve at the time of stopping movement of the liquid in the flow path of the ion-selective electrode 101 (Fig. 1, para. [0036], [0038]-[0039], [0095], [0097]), the liquid for the potential response curve including an ion solution containing interfering ions (Fig. 6, para. [0093], [0103]), so the potential response curve analysis unit 183 is capable of the recitation “detect an influence of the interfering ion in a specimen solution based on the potential change over time obtained from the ion-selective electrode while the specimen solution is stationary after the specimen solution comes in contact with the ion-selective electrode.”
The limitation “while the specimen solution is stationary after the specimen solution comes in contact with the ion-selective electrode” is with respect to an article worked upon (specimen solution) and not a positively recited element of the electrolyte analysis device. Inclusion of the material or article worked upon (specimen solution) by a structure (electrolyte analysis device) being claimed does not impart patentability to the claims. MPEP § 2115.
Regarding claim 2, Kishioka teaches the interfering ion analysis unit (the potential response curve analysis unit 183, Fig. 1, para. [0036]).
The limitation “identify a type of the interfering ion in the specimen based on a direction of a change in a potential waveform” is interpreted as intended use and/or functional language. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP § 2114. The electrolyte concentration measurement device comprising the potential response curve analysis unit disclosed by Kishioka teaches all of the structural limitations of the claim and thus is configured for and capable of the intended use and/or functional language in the claim.
Examiner further notes that Kishioka teaches that the potential response curve analysis unit 183 compares the feature value of the library data with the feature value of the obtained potential response curve to determine contamination of a surface of the ion-selective electrode 101 exposed to an ion solution containing interfering ions, wherein the sign of abnormality is determined by calculating shape features (presence or absence of a convex peak, amplitude thereof, width thereof) of the waveform in the potential response curve and comparing the shape features with a reference value (Figs. 1 & 6, para. [0039], [0093], [0095], [0103]-[0104]), so the potential response curve analysis unit 183 is capable of the recitation “identify a type of the interfering ion in the specimen based on a direction of a change in a potential waveform.”
Regarding claim 3, Kishioka teaches the interfering ion analysis unit (the potential response curve analysis unit 183, Fig. 1, para. [0036]).
The limitation “calculate a concentration of the interfering ion in the specimen based on a slope of a change in a potential waveform” is interpreted as intended use and/or functional language. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP § 2114. The electrolyte concentration measurement device comprising the potential response curve analysis unit disclosed by Kishioka teaches all of the structural limitations of the claim and thus is configured for and capable of the intended use and/or functional language in the claim.
Examiner further notes that Kishioka teaches that the potential response curve analysis unit 183 compares the feature value of the library data with the feature value of the obtained potential response curve to determine contamination of a surface of the ion-selective electrode 101 exposed to an ion solution containing interfering ions, wherein the sign of abnormality is determined by calculating shape features (presence or absence of a convex peak, amplitude thereof, width thereof) of the waveform in the potential response curve and comparing the shape features with a reference value (Figs. 1 & 6, para. [0039], [0093], [0095], [0103]-[0104]), and the concentration of the interfering ions in the sample is calculated at the timing 402 on the potential response curve (Fig. 6, para. [0103]-[0104]), so the potential response curve analysis unit 183 is capable of the recitation “calculate a concentration of the interfering ion in the specimen based on a slope of a change in a potential waveform.”
Regarding claim 5, the limitation “an ion to be measured is an anion” is with respect to an article worked upon (ion to be measured) and not a positively recited element of the electrolyte analysis device. Inclusion of the material or article worked upon (ion to be measured) by a structure (electrolyte analysis device) being claimed does not impart patentability to the claims. MPEP § 2115.
Examiner further notes that Kishioka teaches that an ion to be analyzed is Cl- (para. [0029], [0035], [0037]).
Regarding claim 6, Kishioka teaches the interfering ion analysis unit (the potential response curve analysis unit 183, Fig. 1, para. [0036]).
The limitation “compare a potential waveform of the ion-selective electrode with a potential waveform of an electrode that responds to an ion having an opposite electric charge to an electric charge of an ion to be measured” is interpreted as intended use and/or functional language. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP § 2114. The electrolyte concentration measurement device comprising the potential response curve analysis unit disclosed by Kishioka teaches all of the structural limitations of the claim and thus is configured for and capable of the intended use and/or functional language in the claim.
Examiner further notes that Kishioka teaches that the potential response curve analysis unit 183 compares the feature value of the library data with the feature value of the obtained potential response curve to determine contamination of a surface of the ion-selective electrodes 101A-101C exposed to an ion solution containing interfering ions, wherein the sign of abnormality is determined by calculating shape features (presence or absence of a convex peak, amplitude thereof, width thereof) of the waveform in the potential response curve and comparing the shape features with a reference value (Figs. 1 & 6, para. [0039], [0093], [0095], [0103]-[0104]), and that the ion-selective electrodes 101A-101C include a chlorine ion electrode 101A, a potassium ion electrode 101B, and a sodium ion electrode 101C (Fig. 1, para. [0029]), so the potential response curve analysis unit 183 is capable of the recitation “compare a potential waveform of the ion-selective electrode with a potential waveform of an electrode that responds to an ion having an opposite electric charge to an electric charge of an ion to be measured.”
Regarding claim 7, Kishioka teaches wherein the ion-selective electrode is a flow-type ion-selective electrode (the ion-selective electrode 101 is a flow type ion-selective electrode in the flow type electrolyte concentration measurement device 10, Fig. 1, para. [0027]-[0028]).
Regarding claim 8, Kishioka teaches wherein the ion-selective electrode has a membrane having high-density fixed charges as a sensitive membrane (the ion-selective electrode 101 has an ion-sensitive membrane having an ion balance, Fig. 1, para. [0039], [0105]).
Regarding claim 9, Kishioka teaches wherein the ion-selective electrode has an ion exchange membrane as a sensitive membrane (the ion-selective electrode 101 has an ion-sensitive membrane that changes in surface state and/or ion balance after sample suction where the specimen solution is injected into the ion-selective electrode 101, Fig. 1, para. [0035], [0039], [0105]).
Regarding claim 10, Kishioka teaches wherein the ion-selective electrode has an internal solution (the ion-selective electrode 101 is supplied with an internal standard solution, Fig. 1, para. [0029]), and the internal solution contains high concentration of ions to be measured (the internal standard solution contains a high concentration of the ions to be measured, para. [0037], [0040], [0049]-[0050]).
Regarding claim 11, the limitation “the solution containing ions to be measured is periodically measured” is with respect to an article worked upon (the solution containing ions to be measured) and not a positively recited element of the electrolyte analysis device. Inclusion of the material or article worked upon (the solution containing ions to be measured) by a structure (electrolyte analysis device) being claimed does not impart patentability to the claims. MPEP § 2115.
The limitation “periodically measured” is interpreted as intended use and/or functional language. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP § 2114. The electrolyte concentration measurement device disclosed by Kishioka teaches all of the structural limitations of the claim and thus is configured for and capable of the intended use and/or functional language in the claim.
Examiner further notes that Kishioka teaches that the specific ions in the specimen and the internal standard solution are measured alternately and continuously for continuous analysis (Figs. 1 & 2B, para. [0027], [0041], [0065]-[0066]), so the electrolyte concentration measurement device 10 is capable of the recitation “periodically measured.”
Regarding claim 12, Kishioka teaches an output unit configured to display a detection result of the influence of the interfering ion (an output unit 174 including a display for outputting an arithmetic result of the concentration calculation unit 172 and a deterioration determination result regarding the ion-selective electrode 101, Fig. 1, para. [0037], [0102]).
The limitation “display a detection result of the influence of the interfering ion” is interpreted as intended use and/or functional language. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP § 2114. The electrolyte concentration measurement device disclosed by Kishioka teaches all of the structural limitations of the claim and thus is configured for and capable of the intended use and/or functional language in the claim.
Examiner further notes that Kishioka teaches that the output unit 174 includes a display for outputting an arithmetic result of the concentration calculation unit 172 and a deterioration determination result regarding the ion-selective electrode 101 (Fig. 1, para. [0037], [0102]), so the output unit 174 is capable of the recitation “display a detection result of the influence of the interfering ion.”
Regarding claim 13, Kishioka teaches an input unit (an input unit 176, Fig. 1, para. [0037]).
The limitation “for inputting a characteristic of the ion-selective electrode in the storage unit” is interpreted as intended use and/or functional language. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP § 2114. The input unit disclosed by Kishioka teaches all of the structural limitations of the claim and thus is configured for and capable of the intended use and/or functional language in the claim.
Examiner further notes that Kishioka teaches that the input unit 176 is an interface for inputting various kinds of data or commands to the device control unit 175 which is further connected to the data storage unit 184 (Fig. 1, para. [0036]-[0037]), so the input unit 176 is capable of the recitation “for inputting a characteristic of the ion-selective electrode in the storage unit.”
Regarding claim 14, Kishioka teaches an input unit (an input unit 176, Fig. 1, para. [0037]).
The limitation “for inputting information about the specimen in the storage unit” is interpreted as intended use and/or functional language. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP § 2114. The input unit disclosed by Kishioka teaches all of the structural limitations of the claim and thus is configured for and capable of the intended use and/or functional language in the claim.
Examiner further notes that Kishioka teaches that the input unit 176 is an interface for inputting various kinds of data or commands to the device control unit 175 which is further connected to the data storage unit 184 (Fig. 1, para. [0036]-[0037]), so the input unit 176 is capable of the recitation “for inputting information about the specimen in the storage unit.”
Regarding claim 15, Kishioka teaches wherein the ion-selective electrode includes N ion-selective electrodes having different characteristics (the ion-selective electrode 101 includes a chlorine ion electrode 101A, a potassium ion electrode 101B, and a sodium ion electrode 101C, Fig. 1, para. [0029]).
The limitation “ion concentrations of N+1 or more ion species are measured based on time-series potential waveforms obtained respectively from the ion-selective electrodes” is interpreted as intended use and/or functional language. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP § 2114. The electrolyte concentration measurement device disclosed by Kishioka teaches all of the structural limitations of the claim and thus is configured for and capable of the intended use and/or functional language in the claim.
Examiner further notes that Kishioka teaches that the concentrations of Cl, K, Na ions in the solution can be calculated by measuring the potential differences between the ion-selective electrodes 101A to 101C and generating potential response curve waveforms over time (Fig. 1, para. [0035], [0037]-[0039]), so the electrolyte concentration measurement device 10 is capable of the recitation “ion concentrations of N+1 or more ion species are measured based on time-series potential waveforms obtained respectively from the ion-selective electrodes.”
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Kishioka as applied to claim 1 above, and further in view of Wilke et al. (US 2012/0073989 A1).
Regarding claim 4, Kishioka teaches a concentration calculation unit configured to calculate a concentration of an ion to be measured (a concentration calculation unit 172 calculates a concentration of a specific ion, Kishioka, Fig. 1, para. [0037]).
Kishioka teaches that the concentration calculation unit 172 calculates a concentration of a specific ion based on the potential difference calculated by the potential measuring unit 171 (Kishioka, Fig. 1, para. [0037]). Kishioka teaches that the potential response curve analysis unit 183 analyzes the potential response curve generated by the potential monitoring unit 181 and compares the feature value of the library data with the feature value of the obtained potential response curve to determine contamination of a surface of the ion-selective electrode 101 exposed to an ion solution containing interfering ions (Figs. 1 & 6, para. [0039], [0093], [0095], [0097], [0103]). Kishioka fails to teach wherein the concentration calculation unit is configured to correct the influence and calculates the concentration of the ions to be measured, based on the influence detected by the interfering ion analysis unit.
Wilke teaches a measuring device that determines a measured value of concentration of the measured ion (Wilke, abstract). Wilke teaches that ion-selective electrodes do not respond specifically only to the kind of ion to be measured, but, instead also to other ions, which are referred to as disturbing ions (Wilke, para. [0005]). Wilke teaches that a correction value stored in a data memory is subtracted from each measured value ascertained from a probe measurement signal to compensate for the disturbing influences of disturbing ions and ascertain a corrected measured ion concentration (Wilke, para. [0033]-[0034], [0042], [0049]). Wilke teaches that the correction value is derivable from experiential values or a model of the disturbing influences on the ion selective electrode 2 (Wilke, Fig. 1, para. [0062]). Wilke teaches that this program can be executed by the processor of the data processing system 6 (Wilke, Fig. 1, para. [0062]).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the concentration calculation unit 172 of Kishioka to compensate for the disturbing influences of disturbing ions and correct the measured ion concentration based on the disturbing influences as taught by Wilke because the cross sensitivities of the ion selective electrode may then be compensated and the measured ion concentration is obtained in which corruption by disturbing ions (interfering ions) present is eliminated (Wilke, para. [0014], [0042]).
Conclusion
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/V.T./ Examiner, Art Unit 1794
/JAMES LIN/ Supervisory Patent Examiner, Art Unit 1794