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 .
Status of the Claims
The Amendment filed 01/27/2026 has been entered. Claims 1-2 and 4 have been amended. Claims 3 and 6-7 were previously withdrawn. Claims 5 and 8 were previously canceled. Claims 1-4 and 6-7 are currently pending and Claims 1-2 and 4 are examined herein.
Status of the Rejection
The claim objections have been overcome by the applicant's amendments.
New grounds of claim objections and claim interpretation under 35 U.S.C. § 112(f) are necessitated by the amendments as outlined below.
All 35 U.S.C. § 112(a) rejections from the previous office action are withdrawn in view of the Applicant’s amendments.
The 35 U.S.C. § 112(b) rejections are essentially maintained and modified in response to the amendment. New grounds of rejection under 35 U.S.C. § 112(a) and 112(b) are necessitated by the amendments as outlined below.
All 35 U.S.C. § 102 rejections from the previous office action are withdrawn in view of the Applicant’s amendments.
New grounds of rejection under 35 U.S.C. § 103 are necessitated by the amendments as outlined below.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1, line 18: please amend “with pure water” to –with the pure water --.
Claim 1, line 21: please amend “feeding the reference electrode” to – feeding [[the]]a reference electrode --.
Claim 1, line 23: please amend “and reagent having” to – and the reagent having --.
Claim 1, line 24-25: please amend “measuring the electromotive” to – measuring [[the]]an electromotive --.
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.
Claim 1, “a dilution and restoration unit for diluting the concentrated internal standard solution having a concentration higher than a predetermined ion concentration with the pure water to generate the reagent having the predetermined ion concentration”, is being interpreted under 35 U.S.C. 112(f). Prong 1: a dilution and restoration unit (uses the generic placeholder), prong 2: for diluting … (functional language), prong 3: sufficient structure for performing the function not recited. Therefore, claim 1 invokes 112(f). However, the scope of the term “a dilution and restoration unit” is unclear due to the specification not clearly disclosing the corresponding structure. An explanation is provided in the 35 USC 112(b) rejection below.
Claim 1, “a specimen dispensing mechanism for dispensing the specimen by the specimen dispensing mechanism into the dilution tank”, is being interpreted under 35 U.S.C. 112(f). Prong 1: a specimen dispensing mechanism (uses the generic placeholder), prong 2: for dispensing … (functional language), prong 3: sufficient structure for performing the function not recited. Therefore, claim 1 invokes 112(f). However, the scope of the term “a specimen dispensing mechanism” is unclear due to the specification not clearly disclosing the corresponding structure. An explanation is provided in the 35 USC 112(b) rejection below.
Claim 4, “a specimen dilution unit for diluting a specimen to be analyzed with pure water to generate a diluted specimen”, is being interpreted under 35 U.S.C. 112(f). Prong 1: a specimen dilution unit (uses the generic placeholder), prong 2: for diluting a specimen … (functional language), prong 3: sufficient structure for performing the function not recited. Therefore, claim 1 invokes 112(f). However, the scope of the term “specimen dilution unit” is unclear due to the specification not clearly disclosing the corresponding structure. An explanation is provided in the 35 USC 112(b) rejection below.
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 1-2 and 4 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.
Claim 1 has been amended to recite an analysis unit including a reference electrode solution bottle. However, the instant specification discloses “the analysis unit 102 includes the dilution tank 10, a sipper nozzle 12, a diluent nozzle 18, an internal standard solution nozzle 19, a waste liquid suction nozzle 20, an ion selective electrode (ISE) 1, a reference electrode 2, a pinch valve 17, a voltmeter 25, an amplifier 26, and a computer 27” [see Para. 0022 of the instant specification]. The specification does not disclose the reference electrode solution bottle as part of the analysis unit. In contrast, the specification discloses it is the reagent unit 103 which includes the reference electrode solution bottle: “the reagent unit 103 supplies a reagent used for measurement or cleaning, and includes a concentrated internal standard solution bottle 3, a diluent bottle 4, a reference electrode solution bottle 5, a degassing mechanism 6, filters 15, and a dilution and restoration unit 24 [see Para. 0028 and Fig. 3 of the instant specification]. Therefore claim 1 is new matter. Claims 2 and 4 are further rejected by virtue of its dependence upon claim 1.
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 1-2 and 4 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.
Regarding claim 1, claim 1 recites “higher than a predetermined ion concentration” in lines 8-9. However, it is unclear if the predetermined ion concentration is the same as the predetermined ion concentration recited in lines 2-3 or a different, newly recited predetermined ion concentration, such as a second predetermined ion concentration. Applicant should clarify the relationship between these two predetermined ion concentrations. Therefore, the scope of claim 1 is indefinite. Claims 2 and 4 are further rejected by virtue of its dependence upon and because it fails to cure the deficiencies of claim 1.
Regarding claim 1, the claim limitation “a dilution and restoration unit” invokes 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. The specification merely discloses “a dilution and restoration unit 24” [such as in Para. 0028 of the instant specification]. 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 and 4 are further rejected by virtue of its dependence upon and because it fails to cure the deficiencies of claim 1.
Regarding claim 1, the claim limitation “a specimen dispensing mechanism” invokes 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. The specification merely discloses “a specimen dispensing mechanism 13” [such as in Para. 0020 of the instant specification]. 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 and 4 are further rejected by virtue of its dependence upon and because it fails to cure the deficiencies of claim 1.
Regarding claim 1, claim 1 recites the limitation "the concentrated internal standard solution” in line 7 of claim 1. There is insufficient antecedent basis for this limitation in the claim. Therefore, the scope of claim 1 is indefinite. Claims 2 and 4 are further rejected by virtue of its dependence upon and because it fails to cure the deficiencies of claim 1.
Regarding claim 1, claim 1 recites the limitation "the generated reagent” in line 19 of claim 1. There is insufficient antecedent basis for this limitation in the claim. Furthermore, it is unclear if the generated reagent is the same as the reagent having the predetermined ion concentration obtained by the dilution as recited in claim 1, lines 29-30, or if it refers to a reagent having a predetermined ion concentration as previously recited in claim 1, or if the generated reagent is a newly recited, different element. Therefore, the scope of claim 1 is indefinite. Claims 2 and 4 are further rejected by virtue of its dependence upon and because it fails to cure the deficiencies of claim 1.
Regarding claim 1, claim 1 recites “an analysis unit including….a computer configured to analyze the specimen with the ion selective electrode” in lines 14-16. Due to the wording of the claim, it is unclear if the analysis unit is configured to analyze the specimen or if the computer is configured to analyze the specimen. The examiner suggests applicant to amend the claim to recite “wherein [the computer or the analysis unit] is configured to analyze…”. Therefore, the scope of claim 1 is indefinite. Claims 2 and 4 are further rejected by virtue of its dependence upon and because it fails to cure the deficiencies of claim 1. For the purposes of examination, the claim is interpreted to be at least any of the previously mentioned options.
Regarding claim 1, claim 1 recites “and measuring the electromotive force corresponding to the concentration of the specific ion in the specimen generated by the ion selective electrode” in lines 24-26. However, the claim language is confusing and it is unclear if the applicant means to claim 1) the specimen is generated by the ion selective electrode, 2) the concentration is generated by the ion selective electrode or 3) the electromotive force is generated by the ion selective electrode. Applicant should amend to clarify the claim language in this limitation. Therefore, the scope of claim 1 is indefinite. Claims 2 and 4 are further rejected by virtue of its dependence upon and because it fails to cure the deficiencies of claim 1. For the purposes of examination, the claim is interpreted to be at least any of the previously mentioned options.
Regarding claim 4, claim 4 recites “pure water” in line 2. However, it is unclear if the pure water of line 2 in claim 4 is the same as the pure water recited in line 6 of claim 1 (on which claim 4 depends) or a different, newly recited element of pure water. Applicant should clarify the relationship between these two pure waters. Therefore, the scope of claim 4 is indefinite.
Regarding claim 4, the claim limitation “a specimen dilution unit” invokes 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 specification states “The specimen dispensing unit 101, the dilution tank 10 of the analysis unit 102, the reagent unit 103, and the mechanism unit 104 form a specimen dilution unit for diluting a specimen to be analyzed with a diluent to generate a diluted specimen” in Para. 0042. However, it is unclear if the reagent unit 103 and the mechanism unit 104 of the specimen dilution unit is the same or different as the reagent unit and mechanism unit included in the reagent generation unit, as claimed in claim 1 [see 112f analysis above]. Furthermore, it is unclear how other units which make up the reagent generation unit can also be included in the specimen dilution unit and what are the structures that are overlapping or different between all the claimed units. It is unclear what exactly entails the specimen dilution unit and the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Therefore, the corresponding structure for performing the functional limitation is not described in the specification and without clearly linking the structure to the function and the claim is subsequently indefinite and is 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.
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(s) 1-2 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kishioka et al. (WO-2018020880-A1, references herein made with respect to US equivalent US-20190265187-A1) in view of Hashimoto et al. (JP-2019148572-A, English translation).
Regarding claim 1, an electrolyte analysis apparatus (Kishioka teaches an electrolyte concentration measurement device 400 [Abstract, Fig. 4 and Para. 0096]), the limitation “which measures a concentration of a specific ion in a specimen based on a result of measuring a reagent having a predetermined ion concentration with an ion selective electrode and a result of measuring the specimen with the ion selective electrode” is a functional recitation. Apparatus claims cover what a device is, not what a device does [MPEP 2114(II)]. 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. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, Kishioka teaches the above electrolyte concentration measurement device as shown in Fig. 4 that is specifically configured to perform the functional limitations above (Kishioka teaches measuring the concentration of a specimen and internal standard liquid by ion selective electrodes 101, 102 and 103 and the reference electrode 104 [Paras. 0127-0133 and Fig. 4-5] where the specimen to be analyzed may be serum or urine [Para. 0003, 0071] with the plurality of ion selective electrodes (ISE) corresponding to ions to be detected “specific ions” in order to simultaneously analyze a plurality of ions (sodium ions, potassium ions, calcium ions, chloride ions or the like) [Para. 0004], the electrolyte analysis apparatus which measures the concentration in the specimen based on the result of measuring the internal standard liquid [corresponding to a reagent having a predetermined ion concentration as the internal standard liquid is within a set concentration range, Para. 0124] with the ion selective electrodes and a result of measuring the specimen with the ion selective electrodes [Paras. 0124-0133 and Fig. 4-5], and thus is capable of performing the functional limitations above), comprising:
a reagent generation unit (Kishioka teaches an internal standard liquid preparation unit 440 [Para. 0096-0098 and Fig. 4]) including a concentrated internal standard solution bottle (Kishioka teaches including a drug substance supply unit 448 corresponding to the reagent accommodated in the bottle that supplies a drug substance 447 where the drug substance in the form of concentrated liquid may be used [the drug substance is in a form of concentrated liquid and corresponds to a concentrated internal standard solution] [see e.g., claim 6, Para. 0097 and 0147, Fig. 4]), an internal standard solution syringe connected to pure water (Kishioka teaches an internal standard liquid syringe pump 131 that is connected to pure water through the pure water supply pump 481 that introduces pure water into each preparation container with electromagnetic valves 421 and 424 to which the internal standard liquid syringe pump 131 is connected [Fig. 4, Para. 0161, 0049, 0097]), a dilution and restoration unit for diluting the concentrated internal standard solution having a concentration higher than a predetermined ion concentration with the pure water to generate the reagent having the predetermined ion concentration (Kishioka teaches an internal standard liquid preparation container A441 and an internal standard liquid preparation container B442 “dilution and restoration unit” for diluting and preparing the reagent by introducing pure water through a pure water supply pump 481 into each preparation container where stirring mechanisms 443 and 444 stir and mix the drug substance 447 [the drug substance is in a form of concentrated liquid and corresponds to a concentrated internal standard solution] and the pure water, thus diluting the concentrated internal standard solution having a concentration higher than a predetermined ion concentration with the pure water to generate the reagent/internal standard liquid having the predetermined ion concentration/set concentration range, where the internal standard liquid “reagent” is prepared by supplying pure water to the preparation container A441 using the pure water supply pump 481 while stirring by the stirring unit 443 and the prepared internal standard liquid concentration is calculated (S504) where the ion concentration of the internal standard liquid is within a set concentration range (S505) [see e.g., Paras. 0096-0098, 0101-0102, 0147, 0124-0133 and Figs. 4-5]), wherein the reagent having the predetermined ion concentration is dispensed into a dilution tank (Kishioka teaches the internal standard liquid “reagent” having the predetermined ion concentration/set concentration range is dispensed into the dilution cup 120 [Para. 0103-0110, 0083-0085, 0096 and Figs. 4-5]);
a specimen dispensing mechanism for dispensing the specimen by the specimen dispensing mechanism into the dilution tank (Kishioka teaches a dispensing nozzle for dispensing the specimen into the dilution cup 120 [Para. 0126]);
an analysis unit (Kishioka teaches a measurement unit 470 [Abstract, Para. 0014, 0037-0038, 0161, 0096 claim 1, Figs. 4-5]) including a reference electrode solution bottle (Kishioka teaches including the reference electrode drug substance supply unit 468 that supplies the reference electrode liquid substance 467 which are similar, the drug substance supply unit corresponding to the reagent accommodated in the bottle, where the drug substance in the form of concentrated liquid may be used [Para. 0097, 0147, claim 6, Fig. 4]), the reference electrode (Kishioka teaches the reference electrode 104 [Para. 0127-0128, 0014 and Figs. 4-5]), the dilution tank (Kishioka teaches the dilution cup 120 [Para. 0127-0128, 0014 and Figs. 4-5]), a sipper nozzle (Kishioka teaches sipper nozzle 107 [Para. 0104-0110, 0014 and Figs. 4-5]), the ion selective electrode (Kishioka teaches ion selective electrodes 101, 102 and 103 [Paras. 0102-0110, 0127-0133, 0014 and Fig. 4-5]) and a computer configured to analyze the specimen with the ion selective electrode (Kishioka teaches a control unit 475 that controls the measurement unit, the record and calculation unit, the concentration value correction/determination unit, and the output unit where the measurement unit measuring, by the potential measurement unit, a potential difference when a specimen is supplied to the ion selective electrode and thus the control unit 475 is configured to analyze/measure the specimen with the ion selective electrodes 101, 102, 103 [Para. 0014, 0099, claim 1, Fig. 4-5]);
wherein the computer is configured to control the reagent generation unit for diluting the concentrated internal standard solution with pure water from the internal standard solution syringe (Kishioka teaches the control unit 475 controls the measurement unit 470 which includes as seen in Fig. 4 the internal standard liquid preparation unit 440 and internal standard liquid syringe pump 131 that is connected to pure water through the pure water supply pump 481 that introduces pure water into each preparation container with electromagnetic valves 421 and 424 to which the internal standard liquid syringe pump 131 is connected for diluting and preparing the reagent and the control unit also manages the reagent consumption amount from the analysis frequency, the syringe operation history, or the like [Para. 0161, 0049, 0096-0099, 0101-0102, 0147, 0124-0133, 0014 and Figs. 4-5], thus the control unit is specifically configured to control the reagent generation unit for diluting the concentrated internal standard solution with pure water from the internal standard solution syringe that is connected to pure water through the pure water supply pump 481),
dispensing the generated reagent having the predetermined ion concentration into the dilution tank (Kishioka teaches the control unit 475 controls the measurement unit 470 which includes the internal standard liquid preparation unit 440 and dilution cup 120 as seen in Fig. 4, where the internal standard liquid “generated reagent” having the predetermined ion concentration/set concentration range is dispensed into the dilution cup 120, and the control unit also manages the reagent consumption amount from the analysis frequency, the syringe operation history, or the like [Para. 0096-0099, 0101-0102, 0147, 0124-0133, 0014 and Figs. 4-5], thus the control unit is specifically configured to control dispensing the generated reagent having the predetermined ion concentration into the dilution tank),
dispensing the specimen by the specimen dispensing mechanism into the dilution tank (Kishioka teaches the control unit 475 controls the measurement unit 470 which includes the dispensing nozzle “specimen dispensing mechanism”, where the dispensing nozzle dispenses the specimen into the dilution cup 120, and the control unit also manages the reagent consumption amount from the analysis frequency, the syringe operation history, or the like [Para. 0096-0099, 0101-0102, 0147, 0124-0133, 0014 and Figs. 4-5], thus the control unit is specifically configured to control dispensing the specimen by the specimen dispensing mechanism into the dilution tank),
feeding the reference electrode solution from the reference electrode solution bottle to the reference electrode (Kishioka teaches the control unit 475 controls the measurement unit 470 which includes the reference electrode 104 and the reference electrode drug substance supply unit 468 “reference electrode solution botte” containing the reference electrode liquid substance 467 as seen in Fig. 4, where the reference electrode liquid is introduced into the flow path of the reference electrode 104 from the reference electrode liquid container A461, and the control unit also manages the reagent consumption amount from the analysis frequency, the syringe operation history, or the like [Para. 0096-0099, 0103, 0147, 0124-0133, 0014 and Figs. 4-5], thus the control unit is specifically configured to control feeding the reference electrode solution from the reference electrode solution bottle to the reference electrode),
feeding the specimen and reagent having the predetermined ion concentration from the dilution tank to the ion selective electrode (Kishioka teaches the control unit 475 controls the measurement unit 470 which includes dilution cup 120 and ion selective electrode 101, 102, 103 as seen in Fig. 4 where the diluted specimen in the dilution cup 120 is sucked from the sipper nozzle 107 and introduced into the flow paths 1011, 1021 and 1031 of the ion selective electrodes 101, 102 and 103, as well as the internal standard liquid “reagent” having the predetermined ion concentration/set concentration range in the dilution cup 120 is sucked from the sipper nozzle 107 and introduced into the flow paths 1011, 1021 and 1031 of the ion selective electrodes 101, 102 and 103; the control unit also manages the reagent consumption amount from the analysis frequency, the syringe operation history, or the like [Para. 0096-0099, 0103, 0147, 0124-0133, 0014 and Figs. 4-5], thus the control unit is specifically configured to control feeding the specimen and reagent having the predetermined ion concentration from the dilution tank to the ion selective electrode), and
measuring the electromotive force corresponding to the concentration of the specific ion in the specimen generated by the ion selective electrode (Kishioka teaches the control unit 475 controls the measurement unit 470 which includes the potential measurement unit 471, the record and calculation unit, the concentration value correction/determination unit, and the output unit as seen in Fig. 4, where the electromotive force is measured by the potential measurement unit 471 corresponding to the concentration of the specific ion in the specimen generated by the ion selective electrode 101, 102, 103 [Abstract, Fig. 4, Para. 0014, 0039, 0104-0146] and thus, the control unit is specifically configured to control measuring the electromotive force corresponding to the concentration of the specific ion in the specimen generated by the ion selective electrode).
Kishioka is silent to wherein the computer is further configured to control the reagent generation unit such that an absolute value of a temperature difference between the reagent having the predetermined ion concentration obtained by the dilution with the pure water, and the pure water is smaller than an absolute value of a temperature difference between the reagent having the predetermined ion concentration obtained by the dilution and the concentrated internal standard solution.
However, Kishioka teaches the control unit controls the measurement unit 470 which includes the internal standard liquid preparation unit 440 “reagent generation unit” as seen in Fig. 4 to generate the reagent/internal standard liquid having the predetermined ion concentration/set concentration ranges by mixing the concentrated internal standard solution having a concentration higher than a predetermined ion concentration with the pure water [see e.g., Paras. 0161, 0049, 0096-0099, 0101-0102, 0147, 0124-0133, 0014 and Figs. 4-5]. Kishioka further teaches temperature adjustment [Para. 0102].
Hashimoto discloses an automated analyzer and a dispensing method using pure water to dilute the concentrated reagent to a predetermined concentration, the automated analyzer comprising an electrolyte measurement unit 202 which measures the ion concentration generated from a specific electrolyte [Abstract and Paras. 0001-0004, 0060, 0027]. Hashimoto teaches a control circuit 8 “computer” which calculates the required amount of the first dilution water and the required amount of the second dilution water based on the temperature of the concentrated reagent, the temperature of the first dilution water detected, the temperature of the second dilution water, the dilution ratio of the concentrated reagent, and the reagent volume [Para. 0074-0076]. The control circuit 8 controls the first reagent dispensing unit 25 and dispenses the first diluent water in the amount Y, the second diluent water in the amount Z, and the concentrated reagent in the amount X, all at once from the first reagent dispensing probe 252 into the reaction tube 2111 [Paras. 0081-0084]. Figure 6 shows examples of mixing the concentrated reagent, the first dilution water and the second dilution water [corresponding to diluting the concentrated internal standard solution with pure water to generate the reagent having the predetermined ion concentration] (Para. 0077 and Fig. 6). In the Mixing Example 3, the temperature A of the concentrated reagent, the temperature B of the first dilution water, and the temperature C of the second dilution water are 5°C, 50°C, and 25°C. The difference between the temperature A of the concentrated reagent [the temperature A corresponding to the temperature of the concentrated internal standard solution], the temperature B of the first dilution water [the temperature B corresponding to the temperature of the pure water] and the temperature C of the second dilution water [the temperature C corresponding to the temperature of the pure water] when compared to the target temperature [corresponding to the temperature of the reagent having the predetermined ion concentration obtained by the dilution] is -32ºC, 13ºC, and -12ºC, respectively [Paras. 0077-0080]. Therefore, the absolute value of the temperature difference is 32 ºC, 13 ºC, and 12 ºC, respectively. Thus, the absolute value of a temperature difference between the reagent having the predetermined ion concentration obtained by the dilution [target temperature] and the pure water [the difference is 13 ºC, and 12 ºC] is smaller than an absolute value of a temperature difference between the reagent having the predetermined ion concentration obtained by the dilution [target temperature] and the concentrated internal standard solution [the difference is 32 ºC], because the absolute value of the temperature difference 13 ºC and 12 ºC are smaller both individually and in average compared to the absolute value of the temperature difference 32 ºC. The control circuit 8 controls the reagent generation unit to generate the reagent by mixing the concentrated reagent and pure water in a volume ratio, the volume ratio, for example, of the concentrated reagent, the first dilution water, and the second dilution water being 1:5.6:3.4 [Paras. 0077-0080], such that the absolute value of the temperature differences are obtained as outlined above. Hashimoto further teaches this configuration is suitable for automatic analyzers when processing a large number of samples continuously to perform sample measurements at high speed [Para. 0003-0007].
Kishioka and Hashimoto are considered analogous art to the claimed invention because they are in the same field of automatic analyzer apparatuses [Para. 0003 of Kishioka and Abstract of Hashimoto]. 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 control unit of Kishioka, which controls the reagent generation unit to generate the reagent having the predetermined ion concentration by mixing the concentrated internal standard solution and pure water and performs temperature adjustment, to control the reagent generation unit to perform the mixing of the concentrated internal standard solution and the pure water in a volume ratio such that an absolute value of a temperature difference between the reagent having the predetermined ion concentration obtained by the dilution with the pure water and the pure water is smaller than an absolute value of a temperature difference between the reagent having the predetermined ion concentration obtained by the dilution and the concentrated internal standard solution, as taught by Hashimoto, since Hashimoto teaches this configuration would be suitable for automatic analyzers processing a large number of samples continuously to perform sample measurements at high speed [Para. 0003-0007 of Hashimoto]. Furthermore, the use of a known technique to improve similar devices in the same way is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143 [I][C]).
Regarding claim 2, the electrolyte analysis apparatus according to claim 1, wherein the computer is configured to control the reagent generation unit to generate the reagent having the predetermined ion concentration by mixing the concentrated internal standard solution and the pure water in a volume ratio such that the absolute value of the temperature difference between the reagent having the predetermined ion concentration obtained by the dilution and the pure water is smaller than the absolute value of the temperature difference between the reagent having the predetermined ion concentration obtained by the dilution and the concentrated internal standard solution (As outlined in the rejection of claim 1 above, Modified Kishioka yields the control unit configured to control the reagent generation unit to perform the mixing of the concentrated internal standard solution and the pure water in a volume ratio such that an absolute value of a temperature difference between the reagent having the predetermined ion concentration obtained by the dilution with the pure water, and the pure water is smaller than an absolute value of a temperature difference between the reagent having the predetermined ion concentration obtained by the dilution and the concentrated internal standard solution [see rejection of claim 1 above and see e.g., Paras. 0077-0080 of Hashimoto]).
Regarding claim 4, the electrolyte analysis apparatus according to claim 1, further comprising: a specimen dilution unit for diluting the specimen to be analyzed with pure water to generate a diluted specimen (Kishioka teaches a specimen “to be analyzed” dispensed into a dilution cup 120 by the dispensing nozzle, where the diluent in the diluent preparation container A451 is dispensed into the dilution cup 120 by using the diluent syringe pump 132 and the specimen “to be analyzed” is diluted in the set ratio D, thereafter the diluted specimen in the dilution cup 120 is sucked from the sipper nozzle 107 and introduced into the flow paths 1011, 1021 and 1031 of the ion selective electrodes 101, 102 and 103 [Para. 0126-0127]. Kishioka further teaches a diluent preparation unit 450 which prepares the diluent by introducing pure water from the pure water supply 481 into each preparation container as the pure water supply 481 is connected to the diluent preparation unit 450 and the liquid preparation containers 451 and 452 and the diluent preparation unit 450 similarly supplies the diluted drug substance 457 which is diluted by the pure water supply pump 481 that introduces pure water into each preparation container [0096-0098], the structures of the dispensing nozzle, dilution cup 120, diluent syringe pump 132, and the diluent preparation unit 450 corresponding to a specimen dilution unit for diluting a specimen to be analyzed with pure water [the pure water is contained in the diluent which dilutes the specimen, thus the specimen to be analyzed is diluted with pure water to generate the diluted specimen] to generate a diluted specimen [Para. 0126-0127, 0096-0098 and Figs. 4-5]), wherein
Modified Kishioka is silent to the computer controls the specimen dilution unit to generate the diluted specimen such that an absolute value of a temperature difference between the diluted specimen and the pure water is smaller than an absolute value of a temperature difference between the specimen and the diluted specimen.
However, Kishioka teaches the control unit 475 controls the measurement unit 470 which includes the dispensing nozzle, dilution cup 120, diluent syringe pump 132, and the diluent preparation unit 450 corresponding to a specimen dilution unit as seen in Fig. 4 for diluting a specimen to be analyzed with pure water [the pure water is contained in the diluent which dilutes the specimen, thus the specimen to be analyzed is diluted with pure water to generate the diluted specimen] to generate the diluted specimen [Para. 0126-0127, 0096-0098 and Figs. 4-5].
Hashimoto discloses an automated analyzer and a dispensing method using pure water to dilute the concentrated reagent, the automated analyzer comprising an electrolyte measurement unit 202 which measures the ion concentration generated from a specific electrolyte [Abstract and Paras. 0001-0004, 0060, 0027]. Hashimoto teaches a control circuit 8 “computer” which calculates the required amount of the first dilution water and the required amount of the second dilution water based on the temperature of the concentrated reagent, the temperature of the first dilution water detected, the temperature of the second dilution water, the dilution ratio of the concentrated reagent, and the reagent volume [Para. 0074-0076]. The control circuit 8 controls the first reagent dispensing unit 25 and dispenses the first diluent water in the amount Y, the second diluent water in the amount Z, and the concentrated reagent in the amount X, all at once from the first reagent dispensing probe 252 into the reaction tube 2111 [Paras. 0081-0084]. Figure 6 shows examples of mixing the concentrated reagent, the first dilution water and the second dilution water [corresponding to diluting the specimen to be analyzed with pure water to generate the diluted specimen] (Para. 0077 and Fig. 6). In the Mixing Example 3, the temperature A of the concentrated reagent, the temperature B of the first dilution water, and the temperature C of the second dilution water are 5°C, 50°C, and 25°C. The difference between the temperature A of the concentrated reagent [the temperature A corresponding to the temperature of the specimen], the temperature B of the first dilution water [the temperature B corresponding to the temperature of the pure water] and the temperature C of the second dilution water [the temperature C corresponding to the temperature of the pure water] when compared to the target temperature [corresponding to the temperature of the diluted specimen] is -32ºC, 13ºC, and -12ºC, respectively [Paras. 0077-0080]. Therefore, the absolute value of the temperature difference is 32 ºC, 13 ºC, and 12 ºC, respectively. Thus, the absolute value of a temperature difference between the diluted specimen [target temperature] and the pure water [the difference is 13 ºC, and 12 ºC] is smaller than an absolute value of a temperature difference between the specimen and the diluted specimen [target temperature] [the difference is 32 ºC], because the absolute value of the temperature difference 13 ºC and 12 ºC are smaller both individually and in average compared to the absolute value of the temperature difference 32 ºC. Hashimoto further teaches this configuration is suitable for automatic analyzers when processing a large number of samples continuously to perform sample measurements at high speed [Para. 0003-0007].
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 control unit of Modified Kishioka, which controls the specimen dilution unit to generate the diluted specimen, to control the specimen dilution unit to generate the diluted specimen such that an absolute value of a temperature difference between the diluted specimen and the pure water is smaller than an absolute value of a temperature difference between the specimen and the diluted specimen, as taught by Hashimoto, since Hashimoto teaches this configuration would be suitable for automatic analyzers processing a large number of samples continuously to perform sample measurements at high speed [Para. 0003-0007 of Hashimoto]. Furthermore, the use of a known technique to improve similar devices in the same way is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143 [I][C]).
Response to Arguments
Applicant's arguments, see Remarks Pgs. 8-12, filed 01/27/2026, with respect to the 35 U.S.C. § 102 rejections have been fully considered and all 102 rejections from the previous office action are withdrawn.
Applicant’s Argument #1:
Applicant argues on page 10 that the dilution and restoration unit 24 is provided in a flow path from the concentrated internal standard solution bottle 3 to the dilution tank 10, and is connected to pure water, e.g., supplied from a production device 21 via the flow path.
Examiner’s Response #1:
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the dilution and restoration unit is provided in a flow path from the concentrated internal standard solution bottle 3 to the dilution tank 10, and is connected to pure water, e.g., supplied from a production device 21 via the flow path) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant’s Argument #2:
Applicant argues on page 11 that in the present invention, a dilution ratio in the dilution and restoration unit 24 is controlled in order to generate the internal standard solution at a constant temperature (more specifically, a temperature which can be easily estimated based on a temperature of an environment in which the electrolyte analysis apparatus 100 is provided, and a temperature at which an error that affects the measurement falls within a predetermined acceptable range) by dilution and restoration with pure water regardless of the temperature of the concentrated internal standard solution.
Examiner’s Response #2:
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a dilution ratio in the dilution and restoration unit 24 is controlled… to generate the internal standard solution at a constant temperature, a temperature which can be easily estimated based on a temperature of an environment in which the electrolyte analysis apparatus 100 is provided, and a temperature at which an error that affects the measurement falls within a predetermined acceptable range) by dilution and restoration with pure water regardless of the temperature of the concentrated internal standard solution) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant’s Argument #3:
Applicant argues on page 11 that Kishioka does not disclose controlling a reagent generation unit to dilute a concentrated internal standard solution with pure water to generate a reagent having a predetermined ion concentration, wherein the reagent generation unit is controlled such that an absolute value of a temperature difference between the reagent having the predetermined ion concentration obtained by the dilution with the pure water, and the pure water is smaller than an absolute value of a temperature difference between the reagent having the predetermined ion concentration obtained by the dilution and the concentrated internal standard solution, as claimed in amended claim 1.
Examiner’s Response #3:
Applicant’s arguments have been fully considered, but are moot in view of the new grounds of rejection.
Applicant’s Argument #4:
Applicant argues that the dependent claims are also allowable over the cited combination of documents at least due to the dependency of these claims from an allowable base claim, as well as for the additional features that each recites.
Examiner’s Response #4:
Based on the above responses #1-#3, applicant’s arguments regarding the amended claim 1 are moot in view of the new grounds of rejection.
Regarding applicant’s arguments of the additional features that each of the dependent claims recite, Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/S.Y.O./Examiner, Art Unit 1794
/JAMES LIN/Supervisory Patent Examiner, Art Unit 1794
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