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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 8/2/2023 and 10/25/2023 have been considered by the examiner.
Election/Restrictions
Applicant’s election of Group I, claims 1-8, in the reply filed on 9/12/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Objections
Claims 3-5 and 7 are objected to because of the following informalities:
In claim 3 lines 5-6, “measuring a potential” should be amended to --measuring [[a]] the potential--
In claim 4 line 5, “an abnormality” should be amended to --[[an]] the abnormality--
In claim 5 line 3, “an abnormality” should be amended to --[[an]] the abnormality--
In claim 7 line 3, “an abnormality” should be amended to --[[an]] the abnormality--
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:
Claim 1, “a measurement unit configured to measure a potential difference between the ion-selective electrode and the reference electrode” is being interpreted under 35 U.S.C. 112(f). Prong 1: a measurement unit (uses the generic placeholder), prong 2: configured to measure a potential difference (functional language), prong 3: sufficient structure for performing the function not recited. Therefore, claim 1 invokes 112(f). However, the corresponding structure for performing the functions is described in the specification (paragraphs [0045, 0128] and Fig. 2) such as voltmeter 129.
Claim 1, “a second measurement unit configured to perform a measurement of a measurement item different from that of the electrolyte concentration measurement unit” is being interpreted under 35 U.S.C. 112(f). Prong 1: a second measurement unit (uses the generic placeholder), prong 2: configured to perform a measurement of a measurement item different from that of the electrolyte concentration measurement unit (functional language), prong 3: sufficient structure for performing the function not recited. Therefore, claim 1 invokes 112(f). However, the corresponding structure for performing the functions is described in the specification (paragraphs [0024, 0041] and Fig. 1) such as photometry mechanism 8.
Claim 1, “a dispensing unit configured to perform dispensing of the sample into the electrolyte concentration measurement unit or the second measurement unit” is being interpreted under 35 U.S.C. 112(f). Prong 1: a dispensing unit (uses the generic placeholder), prong 2: configured to perform dispensing of the sample into the electrolyte concentration measurement unit or the second measurement unit (functional language), prong 3: sufficient structure for performing the function not recited. Therefore, claim 1 invokes 112(f). However, the corresponding structure for performing the functions is described in the specification (paragraphs [0018, 0020, 0128] and Fig. 1) such as sampling mechanism 5.
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 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 1-8 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 1 states “a control unit configured to control an operation of each device” in lines 14-15. This limitation is considered indefinite, as it is unclear what “each device” refers to. The only instance of “device” to establish antecedent basis is “An electrolyte measurement device” in line 1. However, this does not establish antecedent basis for a plurality of devices, which is inherent in the statement of “each device,” such that it is unclear what the control unit is configured to control. Claims 2-8 are further rejected by virtue of their dependence upon and because they fail to cure the deficiencies of claim 1.
Claim 6 states “a state of the potential is set to a slope of a temporal change of the measurement potential” in lines 3-4. This limitation is considered indefinite, as it is unclear which of the “potentials each measured by a respective one of the ion-selective electrodes” (see claim 4 lines 6-7) is being referred to as “the potential” and “the measured potential” in this limitation. Claim 7 is further rejected by virtue of its dependence upon and because it fails to cure the deficiencies of claim 6.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Kanehara (JP 2020012823 A, referencing previously furnished machine translation).
Regarding claim 1, Kanehara teaches an electrolyte measurement device (analysis unit 10 in Fig. 2 measures the concentration of a specific ion contained in a solution [0006, 0015]) comprising:
an electrolyte concentration measurement unit (second measurement section 27 including detection unit 40 and signal processing unit 32 in Fig. 3) including an ion-selective electrode (ISE) (detection unit 40 in Figs. 3 and 4 includes three ion selective electrodes 451-453 [0040]) to be supplied with a sample or an internal standard solution (sample or post-calibration liquid flows through detection section 40 via hole 45a to contact each ion selective electrode 451-453 in Fig. 4 [0039, 0042, 0079, 0102], wherein the post-calibration liquid is an internal standard solution with a known concentration), a reference electrode serving as a reference of a potential (reference electrode 454 in detection unit 40 in Fig. 4 provides a reference to generate potentials between each electrode 451-453 [0040-0042]), and a measurement unit (signal processing unit 32 in Fig. 3 [0049]);
a second measurement unit (first measurement section 26 in Fig. 2 [0020]);
a dispensing unit (sample dispensing arm 20 in Fig. 3 [0017, 0023]); and
a control unit configured to control an operation of each device (system control unit 38 in Fig. 1 controls the entire system and performs calculations via calculation unit 34 according to the flowchart in Fig. 15 [0014, 0024-0025, 0037, 0146]), wherein
the control unit measures a potential in a state in which the ion-selective electrode is filled with the internal standard solution (the potentials of the ISEs are measured when the ISEs are filled with the post-calibration solution after a test sample is measured [0149]), and determines presence or absence of an abnormality in the electrolyte concentration measurement unit based on measurement data (calculation unit 34 calculates the slopes of the post calibration signals based on the measured potential over time and determines the presence or absence of an interferent second component in the ISE assembly based on the calculated slope, see Fig. 10 [0093, 0151, 0159]).
The limitation “configured to measure a potential difference between the ion-selective electrode and the reference 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, Kanehara teaches a measurement unit that is configured to perform the functional limitations above (signal processing unit 32 in Fig. 3 collects signals corresponding to the potential detected by detection unit 40 between reference electrode 454 and electrodes 451-453 [0049]).
The limitation “configured to perform a measurement of a measurement item different from that of the electrolyte concentration measurement unit” is a functional recitation. In the instant case, Kanehara teaches a second measurement unit that is configured to perform the functional limitations above (first measurement section 26 detects optical measurement items [0020], differing from the potential measurement items detected by second measurement section 27).
The limitation “configured to perform dispensing of the sample into the electrolyte concentration measurement unit or the second measurement unit” is a functional recitation. In the instant case, Kanehara teaches a dispensing unit that is configured to perform the functional limitations above (sample dispensing arm 20 dispenses each sample into reaction container 17 in Fig. 3 [0017, 0023]).
Kanehara is silent to the limitation wherein the control unit measures the potential when the sample is dispensed into the second measurement unit by the dispensing unit or when the sample is measured by the second measurement unit (Kanehara is silent regarding the timing of the potential measurements in relation to the sample dispensing/measurement process of first measurement section 26).
Given that there are three possible options in Kanehara for when the control unit measures the potential of the ion-selective electrode filled with internal standard solution and determines the presence or absence of an abnormality (e.g., before the sample is measured by the second measurement unit, during the measurement by the second measurement unit, or after the sample is measured by the second measurement unit), it would have been obvious to try the combination wherein, when the sample is measured by the second measurement unit, the control unit measures a potential in a state in which the ion-selective electrode is filled with the internal standard solution, and determines the presence or absence of an abnormality in the electrolyte concentration measurement unit based on measurement data. Choosing from a finite number of identified, predictable solutions, with a reasonable expectation for success, is likely to be obvious to a person of ordinary skill in the art (MPEP 2143(I)(E)). With this configuration, one of ordinary skill in the art would recognize that performing the potential measurement of the ISEs at the same time as the sample measurement by the second measurement unit would conserve experimental time compared to restricting the two measurements to separate time blocks.
Regarding claim 2, modified Kanehara teaches the electrolyte measurement device according to claim 1, and further teaches wherein
the second measurement unit is a colorimetric measurement unit (first measurement section 26 detects optical measurement items [0020]), and
the control unit measures a potential when the sample is measured by the colorimetric measurement unit (as stated in the rejection of claim 1 above, the control unit in modified Kanehara measures the potential of the ISEs when the sample is measured by the second measurement unit).
Regarding claim 3, modified Kanehara teaches the electrolyte measurement device according to claim 1, and further teaches wherein
the control unit determines the presence or absence of an abnormality in the electrolyte concentration measurement unit based on measurement data obtained by measuring a potential twice or more continuously in a state in which the ion-selective electrode is filled with the internal standard solution (to calculate a slope, at least two continuous potential measurements are required, see Fig. 10 [0094, 0128]).
Regarding claim 4, modified Kanehara teaches the electrolyte measurement device according to claim 1, and further teaches wherein
the electrolyte concentration measurement unit includes a plurality of the ion-selective electrodes (detection unit 40 in Figs. 3 and 4 includes three ISEs 451-453 [0040]), and
the control unit determines an abnormality based on a combination of states of potentials each measured by a respective one of the ion-selective electrodes (the determination of an abnormality is based on the electromotive force measurements of all three ISEs [0059-0060]).
Regarding claim 8, modified Kanehara teaches the electrolyte measurement device according to claim 1, and further teaches the device comprising:
a display device (display unit 36 in Fig. 1 [0035]).
The limitation “configured to display at least one of the measurement data and a result of the determination of the presence or absence of an abnormality in the electrolyte concentration measurement unit” 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, modified Kanehara teaches a display device that is configured to perform the functional limitations above (display unit 36 includes a monitor that displays analysis data, calculation results, and warning information for abnormalities [0035, 0129]).
Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Kanehara, as applied to claim 4 above, and further in view of Hirama et al. (JP 2014041060 A, referencing furnished machine translation).
Regarding claim 5, modified Kanehara teaches the electrolyte measurement device according to claim 4, but is silent to the limitation wherein
the control unit identifies a cause of an abnormality based on whether the measured potentials are out of a reference range for all the ion-selective electrodes.
Kanehara teaches that a potential shift from bubble noise should be differentiated from a potential shift from the interferent second component to correctly identify the abnormality [0095].
Hirama teaches an electrolyte measurement device (electrolyte analyzer for analyzing ionic components in Fig. 1 [0001, 0013]) comprising: an electrolyte concentration measurement unit (see Fig. 1) including an ion-selective electrode to be supplied with a sample or an internal standard solution (three ion selective electrodes 11-13 in Fig. 1 is supplied with diluted sample or internal standard solution in Fig. 1 [0014-0015]), a reference electrode serving as a reference of a potential (reference electrode 16 [0014-0015]), and a measurement unit configured to measure a potential difference between the ion-selective electrode and the reference electrode (control unit 20 measures the electromotive force between ion selective electrodes 11-13 and reference electrode 16 [0016]); and a control unit that measures a potential in a state in which the ion-selective electrode is filled with the internal standard solution (control unit 20 measures the electromotive force between ion selective electrodes 11-13 and reference electrode 16 and implements the control process in Fig. 2 [0016, 0026]), and identifies a cause of an abnormality based on whether the measured potentials are out of a reference range for all the ion-selective electrodes (in step S40 in Fig. 2, the electromotive force of the three ISEs contacting the internal standard solution is measured [0026]. This measurement is compared to an electromotive force measurement of the internal standard solution taken between each of the three ISEs in S20, wherein, if the difference in electromotive measurements of all three ISEs from S20 and S40 is the same and exceeds a threshold, the abnormality is identified as bubble noise in Fig. 2 [0028, 0029]). This control method differentiates the abnormality as systemic bubble noise or sample carryover [0028].
Kanehara and Hirama are both considered analogous to the claimed invention because they are in the same field of electrolyte measurement devices based on ion-selective electrodes. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the control unit in Kanehara by configuring the control unit to identify a cause of an abnormality based on whether the measured potentials are out of a reference range for all the ion-selective electrodes (e.g., by determining if the difference in electromotive measurements of all three ISEs from pre and post-calibration in Kanehara is the same and exceeds a threshold), as taught in Hirama, since this would differentiate the abnormality as bubble noise [0028 in Hirama and 0095 in Kanehara]. Furthermore, Hirama teaches the claimed improvement as a known technique that is applicable to the base device in Kanehara. One skilled in the art could have applied the control step for differentiating bubble noise in Hirama in the same way to the base device in Kanehara, yielding predictable results (MPEP 2143(I)(D)).
Regarding claim 6, modified Kanehara teaches the electrolyte measurement device according to claim 5, and further teaches wherein
a state of the potential is set to a slope of a temporal change of the measurement potential (as stated in the rejection of claim 1 above, calculation unit 34 calculates the slopes of the post calibration signals based on the measured potential over time and determines the presence or absence of an interferent second component in the ISE assembly based on the calculated slope, see Fig. 10 [0093, 0151, 0159 in Kanehara]).
Regarding claim 7, modified Kanehara teaches the electrolyte measurement device according to claim 6, wherein
the control unit determines an abnormality based on the slope of a temporal change of the measurement potential (as stated in the rejection of claim 1 above, calculation unit 34 calculates the slopes of the post calibration signals based on the measured potential over time and determines the presence or absence of an interferent second component in the ISE assembly based on the calculated slope, see Fig. 10 [0093, 0151, 0159 in Kanehara]).
Modified Kanehara is silent to the limitation wherein the control unit determines the abnormality based on the slope when the measurement potentials of all the ion-selective electrodes are within the reference range. However, it would be obvious to one of ordinary skill in the art to perform the abnormality analysis based on the slope if bubble noise is not detected (i.e., when the measurement potentials are within the reference range [0028, 0029 in Hirama]), as the abnormality analysis based on the slope is used to calculate the concentration of an interferent component [0093, 0151, 0159 in Kanehara]. Thus, if bubble noise is not identified as the abnormality in the electrolyte concentration measurement unit, analysis of the abnormality based on the slope of the potential would provide further information regarding the interferent component.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAYLEE Y TSENG whose telephone number is (703)756-5542. The examiner can normally be reached Mon - Fri 9-6 PT.
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/K.T./Examiner, Art Unit 1795
/SHIZHI QIAN/Examiner, Art Unit 1795
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