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 .
Claim Rejections - 35 USC § 112
Note that dependent claims will have the deficiencies of base and intervening claims.
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 10-13 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. In claim 10 the limitation “in the reference electrode, the surface of the electrode unit is covered with a protective film, . . .” is ambiguous as it is not clear what is actually covered here with a protective film. Does Applicant mean -- in the reference electrode, its surface is covered with a protective film, . . . – or -- in the reference electrode, its surface within the electrode unit is covered with a protective film, . . . --?
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, 9, 14, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Amano et al. JP 10276762 A based on an EPO machine-generated English language translation (hereafter “Amano”) and in view of Miyahara et al. US 2008/0197023 A1 (hereafter “Miyahara”) and Wieder et al. US 2009/0057148 A1 (hereafter “Wieder”) or Saito et al. JP 2001066275 based on an EPO machine-generated English language translation (hereafter ‘Saito”).
Addressing claim 1, Amano discloses a sample measurement device (see
Figure 1 and paragraph [0017] (“FIG. 1 is a schematic view showing an embodiment of the cell activity measuring apparatus of the present invention.“)), comprising:
an electrode unit (22 in Figure 2 (excluding the lead wires 22e and the external connection terminal 22f) and any of the projecting portions of 22 in Figure 3) including at least a working electrode (22b; paragraph [0018]), a counter electrode (22c; paragraph [0018]), and a reference electrode(22d; paragraph [0018]) of a sample measurement sensor (all of Figure 2 or all of Figure 3) in a state in which the electrode unit is immersed in a sample (this feature may be inferred from Figures 4 and 5 noting that 23 denotes a measurement cell in which sample is understood to have been placed. See also paragraph [0024]. Also see the first sente of paragraph [0020].);
a current measurement unit configured to measure a current flowing through the sample measurement sensor by the voltage applied to the electrode unit (although not shown, this current measurement unit may be inferred from Figure 7 which shows current versus time curves for measurements made under different conditions (see paragraph [0026]) and from the following in paragraph [0020], “Therefore, an oxygen electrode is inserted into each measurement cell of the cassette 1 by the electrode
insertion unit 18, and an electrical connection is made between the oxygen electrode and the data processing unit 16 by the electrode connection unit 15. In FIG. 3, the electrical signal output from the oxygen electrode can be input to perform predetermined data processing, and the cell activity measurement result can be output. [italicizing by the Examiner]”);
a concentration measurement unit configured to calculate a concentration of an analyte contained in the sample on the basis of a measurement result from the current measurement unit (this concentration measurement unit is understood to be part of data processing unit 16 as Amano states, “ . . . ., and a data processing unit 16 for performing predetermined data processing by inputting an electrical signal
output from the oxygen electrode and outputting a cell activity measurement result…” (paragraph [0017]), and “. . . ., the effective concentration of the drug is measured. [paragraph [0013]”).
Amano does not explicitly disclose “a voltage application unit configured to apply voltage to” the electrode unit, although this may be reasonably inferred as Amano does disclose, as indicated above an electrode unit including at least a working electrode, a counter electrode, and a reference electrode; a current measurement unit configured to measure a current flowing through the sample measurement sensor by the voltage applied to the electrode unit; and a concentration measurement unit configured to calculate a concentration of an analyte contained in the sample on the basis of a measurement result from the current measurement unit.
Miyahara discloses an oxygen sensor for use with microorganisms (see the title, Figures 2 and 3, and paragraph [0001]), the oxygen sensor comprising a voltage application unit configured to apply voltage to an electrode unit (implied by “an oxygen electrode at a predetermined temperature and at a predetermined constant voltage. [italicizing by the Examiner]“ See also the first sentence of paragraph [0044] and
claim 9.) including at least a working electrode (22; paragraph [0045]), a counter electrode (21; paragraph [0045]), and a reference electrode (23; paragraph [0045]) of a sample measurement sensor (1 in Figure 3 and paragraph [0044]); a current measurement unit (3 in Figure 2) configured to measure a current flowing through the sample measurement sensor by the voltage applied to the electrode unit (“The oxygen electrode 2 is connected to a current measurement unit 3 through the output terminal 24.” See paragraph [0044]. Also see paragraph [0046] and claim 9.).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to provide a voltage application unit as taught by Miyahara to apply voltage to the electrode unit of Amano, if in fact not already intended, because this will be prima facie obvious as simple substitution of one known element (means to cause a measurement current for an oxygen sensor comprising a working electrode, a counter electrode, and a reference electrode) for another to obtain predictable results. See MPEP 2143(I)(B).
Amano also does not disclose, as required by claim 1,
a counter electrode terminal voltage measurement unit configured to measure a terminal voltage of the counter electrode included in the electrode unit in a state in which a voltage is being applied by the voltage application unit; and
a measurement error detection unit configured to detect a measurement error on the basis of the terminal voltage of the counter electrode measured by the counter electrode terminal voltage measurement unit.
Wieder discloses a “measuring system for in vivo monitoring of an analyte concentration with malfunction detection, comprises an electrode system, a potentiostat and an evaluation unit. The electrode system has a working electrode, a reference electrode, and a counter electrode.” See the Abstract. This measuring system includes a counter electrode terminal voltage measurement unit configured to measure a terminal voltage of the counter electrode included in the electrode unit in a state in which a voltage is being applied by the voltage application unit. This counter electrode terminal voltage measurement unit is understood to be part of evaluation unit 9 from the following
PNG
media_image1.png
60
426
media_image1.png
Greyscale
PNG
media_image2.png
84
458
media_image2.png
Greyscale
(see Wieder claim 11);
PNG
media_image3.png
140
474
media_image3.png
Greyscale
(see Wieder claim 12);
PNG
media_image4.png
68
440
media_image4.png
Greyscale
;
and
PNG
media_image5.png
148
484
media_image5.png
Greyscale
(see the Wieder Abstract).
Wieder further discloses a measurement error detection unit configured to detect a measurement error on the basis of the terminal voltage of the counter electrode measured by the counter electrode terminal voltage measurement unit. This measurement error detection unit is understood to be part of evaluation unit 9 from the following
PNG
media_image6.png
85
458
media_image6.png
Greyscale
(see Wieder claim 11);
PNG
media_image7.png
140
474
media_image7.png
Greyscale
(see Wieder claim 12);
and
PNG
media_image8.png
148
484
media_image8.png
Greyscale
(see the Wieder Abstract).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to provide a counter electrode terminal voltage measurement unit together with a measurement error detection unit as taught by Wieder in the sample measurement device of Amano as modified by Miyahara because Wieder discloses
PNG
media_image9.png
315
476
media_image9.png
Greyscale
PNG
media_image10.png
135
476
media_image10.png
Greyscale
Alternatively, Saito discloses “. . . . an electrochemical sensor device having a working electrode, a counter electrode and a reference electrode and a
measuring method using the same, and particularly to the above-mentioned three problems such as disconnection or short circuit of an electric wiring system. The present invention relates to a technique for detecting an abnormality of a device caused by a failure of a portion other than an electrode.” See the paragraph [0001]. Saito further discloses a counter electrode terminal voltage measurement unit configured to measure a terminal voltage of the counter electrode included in the electrode unit in a state in which a voltage is being applied by the voltage application unit; and a measurement error detection unit configured to detect a measurement error on the basis of the terminal voltage of the counter electrode measured by the counter electrode terminal voltage measurement unit. This counter electrode terminal voltage measurement unit and measurement error detection unit may be inferred from the following
PNG
media_image11.png
260
740
media_image11.png
Greyscale
PNG
media_image12.png
182
766
media_image12.png
Greyscale
PNG
media_image13.png
110
754
media_image13.png
Greyscale
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to provide a counter electrode terminal voltage measurement unit together with a measurement error detection unit as taught by Saito in the sample measurement device of Amano as modified by Miyahara because this allow any disconnection involving the counter electrode be detected, so that the operator of the sample measurement device may stop the measurement in order to effect a repair so as to avoid erroneous measurement.
Addressing claim 9, as for “display unit configured to display a detection result for the measurement error in the measurement error detection unit…”, as a first matter note that one of ordinary skill in the art would recognize data processing unit 16 in Amano Figure 1 to be a computer including display unit that is configured to detection result, such as a current versus time graph as shown in Figure 3. Also, Wieder discloses a display unit configured to display a detection result. See Amano Figure 1 and the last sentence of paragraph [0025]. Moreover, the display unit of Wieder is also configured to display a detection result for the measurement error in the measurement error detection unit. See Wieder claim 9 and paragraph [0027](“The malfunction signal may be transmitted to a user as a visual or an acoustic warning signal, for example. [italicizing by the Examiner]“). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to configure the display unit of Amano to also display a detection result for the measurement error in the measurement error detection unit as taught by Wieder because if the malfunction is not temporary than the operator of the sample measurement device will know that the sample measurement should be halted as the measurement results will be erroneous, perhaps significantly so, and that some section of the sample measurement device needs maintenance, repair, or even perhaps to be replaced.
Alternatively, in view of Saito It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to configure the display unit of Amano to also display a detection result for the measurement error in the measurement error detection unit because as stated in the rejection of underlining
claim 1 “. . . .any disconnection involving the counter electrode [can] be detected, so that the operator of the sample measurement device may stop the measurement in order to effect a repair so as to avoid erroneous measurement.
Addressing claim 14, Amano discloses a sample measurement device (see
Figure 1 and paragraph [0017] (“FIG. 1 is a schematic view showing an embodiment of the cell activity measuring apparatus of the present invention.“)), comprising:
an electrode unit (22 in Figure 2 (excluding the lead wires 22e and the external connection terminal 22f) and any of the projecting portions of 22 in Figure 3) including at least a working electrode (22b; paragraph [0018]), a counter electrode (22c; paragraph [0018]), and a reference electrode(22d; paragraph [0018]) of a sample measurement sensor (all of Figure 2 or all of Figure 3) in a state in which the electrode unit is immersed in a sample (this feature may be inferred from Figures 4 and 5 noting that 23 denotes a measurement cell in which sample is understood to have been placed. See also paragraph [0024]. Also see the first sente of paragraph [0020].);
a current measurement unit configured to measure a current flowing through the sample measurement sensor by the voltage applied to the electrode unit (although not shown, this current measurement unit may be inferred from Figure 7 which shows current versus time curves for measurements made under different conditions (see paragraph [0026]) and from the following in paragraph [0020], “Therefore, an oxygen electrode is inserted into each measurement cell of the cassette 1 by the electrode
insertion unit 18, and an electrical connection is made between the oxygen electrode and the data processing unit 16 by the electrode connection unit 15. In FIG. 3, the electrical signal output from the oxygen electrode can be input to perform predetermined data processing, and the cell activity measurement result can be output. [italicizing by the Examiner]”);
a concentration measurement unit configured to calculate a concentration of an analyte contained in the sample on the basis of a measurement result from the current measurement unit (this concentration measurement unit is understood to be part of data processing unit 16 as Amano states, “ . . . ., and a data processing unit 16 for performing predetermined data processing by inputting an electrical signal
output from the oxygen electrode and outputting a cell activity measurement result…” (paragraph [0017]), and “. . . ., the effective concentration of the drug is measured. [paragraph [0013]”).
Amano does not explicitly disclose “a voltage application unit configured to apply voltage to” the electrode unit, although this may be reasonably inferred as Amano does disclose, as indicated above an electrode unit including at least a working electrode, a counter electrode, and a reference electrode; a current measurement unit configured to measure a current flowing through the sample measurement sensor by the voltage applied to the electrode unit; and a concentration measurement unit configured to calculate a concentration of an analyte contained in the sample on the basis of a measurement result from the current measurement unit.
Miyahara discloses an oxygen sensor for use with microorganisms (see the title, Figures 2 and 3, and paragraph [0001]), the oxygen sensor comprising a voltage application unit configured to apply voltage to an electrode unit (implied by “an oxygen electrode at a predetermined temperature and at a predetermined constant voltage. [italicizing by the Examiner]“ See also the first sentence of paragraph [0044] and
claim 9.) including at least a working electrode (22; paragraph [0045]), a counter electrode (21; paragraph [0045]), and a reference electrode (23; paragraph [0045]) of a sample measurement sensor (1 in Figure 3 and paragraph [0044]); a current measurement unit (3 in Figure 2) configured to measure a current flowing through the sample measurement sensor by the voltage applied to the electrode unit (“The oxygen electrode 2 is connected to a current measurement unit 3 through the output terminal 24.” See paragraph [0044]. Also see paragraph [0046] and claim 9.).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to provide a voltage application unit as taught by Miyahara to apply voltage to the electrode unit of Amano, if in fact not already intended, because this will be prima facie obvious as simple substitution of one known element (means to cause a measurement current for an oxygen sensor comprising a working electrode, a counter electrode, and a reference electrode) for another to obtain predictable results. See MPEP 2143(I)(B).
Amano also does not disclose, as required by claim 1,
a counter electrode terminal voltage measurement unit configured to measure a terminal voltage of the counter electrode included in the electrode unit in a state in which a voltage is being applied by the voltage application unit; and
a measurement error detection unit configured to detect a measurement error on the basis of the terminal voltage of the counter electrode measured by the counter electrode terminal voltage measurement unit.
Wieder discloses a “measuring system for in vivo monitoring of an analyte concentration with malfunction detection, comprises an electrode system, a potentiostat and an evaluation unit. The electrode system has a working electrode, a reference electrode, and a counter electrode.” See the Abstract. This measuring system includes a counter electrode terminal voltage measurement unit configured to measure a terminal voltage of the counter electrode included in the electrode unit in a state in which a voltage is being applied by the voltage application unit. This counter electrode terminal voltage measurement unit is understood to be part of evaluation unit 9 from the following
PNG
media_image1.png
60
426
media_image1.png
Greyscale
PNG
media_image2.png
84
458
media_image2.png
Greyscale
(see Wieder claim 11);
PNG
media_image3.png
140
474
media_image3.png
Greyscale
(see Wieder claim 12);
PNG
media_image4.png
68
440
media_image4.png
Greyscale
;
and
PNG
media_image5.png
148
484
media_image5.png
Greyscale
(see the Wieder Abstract).
Wieder further discloses a measurement error detection unit configured to detect a measurement error on the basis of the terminal voltage of the counter electrode measured by the counter electrode terminal voltage measurement unit. This measurement error detection unit is understood to be part of evaluation unit 9 from the following
PNG
media_image6.png
85
458
media_image6.png
Greyscale
(see Wieder claim 11);
PNG
media_image7.png
140
474
media_image7.png
Greyscale
(see Wieder claim 12);
and
PNG
media_image8.png
148
484
media_image8.png
Greyscale
(see the Wieder Abstract).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to provide a counter electrode terminal voltage measurement unit together with a measurement error detection unit as taught by Wieder in the sample measurement device of Amano as modified by Miyahara because Wieder discloses
PNG
media_image9.png
315
476
media_image9.png
Greyscale
PNG
media_image10.png
135
476
media_image10.png
Greyscale
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to perform all of the steps set forth in Applicant’s claim 14 because the sample measurement device of Amano as modified by Miyahara and Wieder as just discussed is clearly constructed and intended to perform these steps.
Alternatively, Saito discloses “. . . . an electrochemical sensor device having a working electrode, a counter electrode and a reference electrode and a
measuring method using the same, and particularly to the above-mentioned three problems such as disconnection or short circuit of an electric wiring system. The present invention relates to a technique for detecting an abnormality of a device caused by a failure of a portion other than an electrode.” See the paragraph [0001]. Saito further discloses a counter electrode terminal voltage measurement unit configured to measure a terminal voltage of the counter electrode included in the electrode unit in a state in which a voltage is being applied by the voltage application unit; and a measurement error detection unit configured to detect a measurement error on the basis of the terminal voltage of the counter electrode measured by the counter electrode terminal voltage measurement unit. This counter electrode terminal voltage measurement unit and measurement error detection unit may be inferred from the following
PNG
media_image11.png
260
740
media_image11.png
Greyscale
PNG
media_image12.png
182
766
media_image12.png
Greyscale
PNG
media_image13.png
110
754
media_image13.png
Greyscale
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to provide a counter electrode terminal voltage measurement unit together with a measurement error detection unit as taught by Saito in the sample measurement device of Amano as modified by Miyahara because this allow any disconnection involving the counter electrode be detected, so that the operator of the sample measurement device may stop the measurement in order to effect a repair so as to avoid erroneous measurement.
Addressing claim 15, Amano discloses a sample measurement device (see
Figure 1 and paragraph [0017] (“FIG. 1 is a schematic view showing an embodiment of the cell activity measuring apparatus of the present invention.“)), comprising:
an electrode unit (22 in Figure 2 (excluding the lead wires 22e and the external connection terminal 22f) and any of the projecting portions of 22 in Figure 3) including at least a working electrode (22b; paragraph [0018]), a counter electrode (22c; paragraph [0018]), and a reference electrode(22d; paragraph [0018]) of a sample measurement sensor (all of Figure 2 or all of Figure 3) in a state in which the electrode unit is immersed in a sample (this feature may be inferred from Figures 4 and 5 noting that 23 denotes a measurement cell in which sample is understood to have been placed. See also paragraph [0024]. Also see the first sente of paragraph [0020].);
a current measurement unit configured to measure a current flowing through the sample measurement sensor by the voltage applied to the electrode unit (although not shown, this current measurement unit may be inferred from Figure 7 which shows current versus time curves for measurements made under different conditions (see paragraph [0026]) and from the following in paragraph [0020], “Therefore, an oxygen electrode is inserted into each measurement cell of the cassette 1 by the electrode
insertion unit 18, and an electrical connection is made between the oxygen electrode and the data processing unit 16 by the electrode connection unit 15. In FIG. 3, the electrical signal output from the oxygen electrode can be input to perform predetermined data processing, and the cell activity measurement result can be output. [italicizing by the Examiner]”);
a concentration measurement unit configured to calculate a concentration of an analyte contained in the sample on the basis of a measurement result from the current measurement unit (this concentration measurement unit is understood to be part of data processing unit 16 as Amano states, “ . . . ., and a data processing unit 16 for performing predetermined data processing by inputting an electrical signal
output from the oxygen electrode and outputting a cell activity measurement result…” (paragraph [0017]), and “. . . ., the effective concentration of the drug is measured. [paragraph [0013]”).
Amano does not explicitly disclose “a voltage application unit configured to apply voltage to” the electrode unit, although this may be reasonably inferred as Amano does disclose, as indicated above an electrode unit including at least a working electrode, a counter electrode, and a reference electrode; a current measurement unit configured to measure a current flowing through the sample measurement sensor by the voltage applied to the electrode unit; and a concentration measurement unit configured to calculate a concentration of an analyte contained in the sample on the basis of a measurement result from the current measurement unit.
Miyahara discloses an oxygen sensor for use with microorganisms (see the title, Figures 2 and 3, and paragraph [0001]), the oxygen sensor comprising a voltage application unit configured to apply voltage to an electrode unit (implied by “an oxygen electrode at a predetermined temperature and at a predetermined constant voltage. [italicizing by the Examiner]“ See also the first sentence of paragraph [0044] and
claim 9.) including at least a working electrode (22; paragraph [0045]), a counter electrode (21; paragraph [0045]), and a reference electrode (23; paragraph [0045]) of a sample measurement sensor (1 in Figure 3 and paragraph [0044]); a current measurement unit (3 in Figure 2) configured to measure a current flowing through the sample measurement sensor by the voltage applied to the electrode unit (“The oxygen electrode 2 is connected to a current measurement unit 3 through the output terminal 24.” See paragraph [0044]. Also see paragraph [0046] and claim 9.).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to provide a voltage application unit as taught by Miyahara to apply voltage to the electrode unit of Amano, if in fact not already intended, because this will be prima facie obvious as simple substitution of one known element (means to cause a measurement current for an oxygen sensor comprising a working electrode, a counter electrode, and a reference electrode) for another to obtain predictable results. See MPEP 2143(I)(B).
Amano also does not disclose, as required by claim 1,
a counter electrode terminal voltage measurement unit configured to measure a terminal voltage of the counter electrode included in the electrode unit in a state in which a voltage is being applied by the voltage application unit; and
a measurement error detection unit configured to detect a measurement error on the basis of the terminal voltage of the counter electrode measured by the counter electrode terminal voltage measurement unit.
Wieder discloses a “measuring system for in vivo monitoring of an analyte concentration with malfunction detection, comprises an electrode system, a potentiostat and an evaluation unit. The electrode system has a working electrode, a reference electrode, and a counter electrode.” See the Abstract. This measuring system includes a counter electrode terminal voltage measurement unit configured to measure a terminal voltage of the counter electrode included in the electrode unit in a state in which a voltage is being applied by the voltage application unit. This counter electrode terminal voltage measurement unit is understood to be part of evaluation unit 9 from the following
PNG
media_image1.png
60
426
media_image1.png
Greyscale
PNG
media_image2.png
84
458
media_image2.png
Greyscale
(see Wieder claim 11);
PNG
media_image3.png
140
474
media_image3.png
Greyscale
(see Wieder claim 12);
PNG
media_image4.png
68
440
media_image4.png
Greyscale
;
and
PNG
media_image5.png
148
484
media_image5.png
Greyscale
(see the Wieder Abstract).
Wieder further discloses a measurement error detection unit configured to detect a measurement error on the basis of the terminal voltage of the counter electrode measured by the counter electrode terminal voltage measurement unit. This measurement error detection unit is understood to be part of evaluation unit 9 from the following
PNG
media_image6.png
85
458
media_image6.png
Greyscale
(see Wieder claim 11);
PNG
media_image7.png
140
474
media_image7.png
Greyscale
(see Wieder claim 12);
and
PNG
media_image8.png
148
484
media_image8.png
Greyscale
(see the Wieder Abstract).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to provide a counter electrode terminal voltage measurement unit together with a measurement error detection unit as taught by Wieder in the sample measurement device of Amano as modified by Miyahara because Wieder discloses
PNG
media_image9.png
315
476
media_image9.png
Greyscale
PNG
media_image10.png
135
476
media_image10.png
Greyscale
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to create a sample measurement program as set forth in Applicant’s claim 15 because (1) the sample measurement device of Amano as modified by Miyahara and Wieder as just discussed is clearly constructed and intended to perform these steps, and (2) one of ordinary skill in the art would recognize data processing unit 16 in Amano Figure 1 to be a computer, so at the least, the claimed sample measurement program is prima facie obvious as automating a manual activity. See MPEP 2144.04(III).
Alternatively, Saito discloses “. . . . an electrochemical sensor device having a working electrode, a counter electrode and a reference electrode and a
measuring method using the same, and particularly to the above-mentioned three problems such as disconnection or short circuit of an electric wiring system. The present invention relates to a technique for detecting an abnormality of a device caused by a failure of a portion other than an electrode.” See the paragraph [0001]. Saito further discloses a counter electrode terminal voltage measurement unit configured to measure a terminal voltage of the counter electrode included in the electrode unit in a state in which a voltage is being applied by the voltage application unit; and a measurement error detection unit configured to detect a measurement error on the basis of the terminal voltage of the counter electrode measured by the counter electrode terminal voltage measurement unit. This counter electrode terminal voltage measurement unit and measurement error detection unit may be inferred from the following
PNG
media_image11.png
260
740
media_image11.png
Greyscale
PNG
media_image12.png
182
766
media_image12.png
Greyscale
PNG
media_image13.png
110
754
media_image13.png
Greyscale
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to provide a counter electrode terminal voltage measurement unit together with a measurement error detection unit as taught by Saito in the sample measurement device of Amano as modified by Miyahara because this allow any disconnection involving the counter electrode be detected, so that the operator of the sample measurement device may stop the measurement in order to effect a repair so as to avoid erroneous measurement.
Other Relevant Prior Art
The International Search Report for international application no. PCT/JP2022/046633 cites JP 2001-66275 A as a “X” document against claims 1 and 14-15, and as a “Y” document against claims 2 and 5-9; JP 2001-174436 A is cited as a “Y” document against claims 2 and 5-9; and JP 2011-99717 A is cited as a “Y” document against claims 5-9.
Regarding JP 2001-66275 A, it is Saito applied in the rejections under
35 U.S.C 103 above.
Regarding JP 2001-174436 A, based on an English language translation obtained by the U.S. Examiner it does not disclose a counter electrode terminal voltage measurement unit or a measurement error detection unit as set forth in claim 1 of U.S. application 18/749209 nor the additional features of claims 2 and 5 of the U.S. application.
Regarding JP2011-99717 A, based on an English language translation obtained by the U.S. Examiner it does not disclose a counter electrode terminal voltage measurement unit or a measurement error detection unit as set forth in claim 1 of U.S. application 18/749209 nor the additional features of claims 2 and 5 of the U.S. application.
The Extended European Search Report dated January 22, 2025 issued in the corresponding European Patent Application No. 22924150.0 cites EP 2030561 A as an “X” document against claims 1, 9, 14, and 15 of that application and as a ‘Y” document against claims 2, 3, 5-8, and 10-13; cites JP 2001-174436 A as a “Y” document against claims 2 and 3; cites JP 2021-101643 A as a “Y” document against claims 5-8; cites
JP 2021-185850 A as a “Y” document against claims 1013; and cites JP 2001-066275 A as an “X” document against claims 1, 14, and 15.
Regarding EP 2030561 A, Wieder applied in the rejections under 35 U.S.C. 103 above is an English language equivalent.
Regarding JP 2001-174436 A, it has already been commented upon in the discussion of the International Search Report just above.
Regarding JP 2021-101643 A, based on an English language translation obtained by the U.S. Examiner, while it does disclose using an electrode to determine if there is immersion error caused by improper immersion of a sensor into a sample container, the immersion electrode is not a counter electrode or part of the measurement electrode set, but part of a separate electrical circuit. See paragraphs [0005], [0010], [0016], [0018], [0027], [0050], and Figures 14, 15, 19, 21,and 231.
Regarding JP 2021-185850 A, based on an English language translation obtained by the U.S. Examiner, it does not seem to disclose having the surface of the reference electrode be covered with a protective film, only the reagent on the working elected is covered with a protective film. See paragraphs [0016], [0013], and [0031]. In any event, it seems that even if the surface of the reference electrode were to be covered with a protective film, so would the surface of the counter electrode.
The Japanese Office Action dated February 4, 2025 issued in corresponding Japanese Patent Application No. 2023-576695, with English machine translation cites and applies in rejections JP 2001-66275 A, JP 2001-174436 A, and JP2011-99717 A. These three documents have already been commented upon above in the discussion about the International Search Report
Allowable Subject Matter
Claims 2-8 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 10-13 would be allowable if rewritten to overcome the rejection under
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
a) in claim 2 the combination of limitations includes the following underlined feature
PNG
media_image14.png
128
650
media_image14.png
Greyscale
In contrast, Amano as modified by Miyahara and Wieder discloses
PNG
media_image15.png
116
474
media_image15.png
Greyscale
(see Wieder paragraph [0032]).
In contrast, Amano as modified by Miyahara and alternatively Saito discloses detecting a disconnection involving the counter electrode. See Saito paragraph [0028].
While measurement error detection units capable of detecting a contamination error attributable to an admixture of an impurity other than the sample are known in the electrochemical sensor art they are not “configured to detect a measurement error on the basis of the terminal voltage of the counter electrode measured by the counter electrode terminal voltage measurement unit…” as required by underlying Applicant’s claim 1. For example, Lakshmana et al. US 20190271693 A1 (hereafter “Lakshmana“) discloses “methods, compositions, devices, and kits for detecting bacteriophage contamination in a sample.” See the Abstract. Lakshmana paragraph [0166] states,
PNG
media_image16.png
332
440
media_image16.png
Greyscale
Brown et al. 10,106,847 B1 discloses an electrotechnical method for detecting whether blood or other bodily fluid has been contaminated by skin cells, bacteria, fungi, and phages. The method comprises “electrochemically detecting an amount of hybridization complex above a threshold thereby detecting the viable gram-positive microorganism, and not detecting the nucleic acid from the non-viable gram-positive microorganism present in the blood culture medium.” See the title, col. 2:63 – col. 3:14, col. 48:16-44, and claim 1, step (c).
b) claims 3 and 4 depend directly or indirectly from allowable claim 2.
c) in claim 5 the combination of limitations includes the following underlined feature
PNG
media_image17.png
174
660
media_image17.png
Greyscale
In contrast, Amano as modified by Miyahara and Wieder discloses
PNG
media_image15.png
116
474
media_image15.png
Greyscale
(see Wieder paragraph [0032]).
In contrast, Amano as modified by Miyahara and alternatively Saito discloses detecting a disconnection involving the counter electrode. See Saito paragraph [0028].
While measurement error detection units capable of detecting an improper immersion error caused by improper immersion in which the electrode unit is not properly immersed in the sample are known in the biological sensor art they are not “configured to detect a measurement error on the basis of the terminal voltage of the counter electrode measured by the counter electrode terminal voltage measurement unit…” as required by underlying Applicant’s
claim 1. For example, Hyde et al. US 4,615,866 (hereafter “Hyde”) discloses a fluid-sampling system and method. See the title and col. 1:1-10. This system includes “serum level detecting means 13 for detecting the proper immersion of the sampler assembly into the serum specimen to be sampled; . . . .” See
col. 4:3-5. Hyde further states,
PNG
media_image18.png
210
418
media_image18.png
Greyscale
PNG
media_image19.png
144
432
media_image19.png
Greyscale
See col. 8:59 – col. 9:8.
Also see Hyde claims 26 and 31.
JP 2021-101643 A, based on an English language translation obtained by the U.S. Examiner, does disclose using an electrode to determine if there is immersion error caused by improper immersion of a sensor into a sample container, it is not a counter electrode or part of the measurement electrode set, but part of a separate electrical circuit. See paragraphs [0005], [0010], [0016], [0018], [0027], [0050], and Figures 14, 15, 19, 21,and 232. So, the additional limitation of claim 5 is not met by this document.
d) claims 6-8 depend directly or indirectly from allowable claim 5.
e) in claim 10 the combination of limitations includes the following underlined feature3
PNG
media_image20.png
346
710
media_image20.png
Greyscale
In contrast, Amano as modified by Miyahara and Wieder does not disclose “in the working electrode, a reagent applied to a surface of the electrode unit is covered with a protective film, . . . .” It would have been obvious to one of ordinary skill in the art to modify the electrode unit of Amano as modified by Miyahara and Wieder to have this feature in light of McAleer et al. US 5,876,577 the title, Abstract, Figures 3, 4a, and 4b, and col. 3:62 – col.4: 43, leaving in the counter electrode, an electrode portion that is exposed to the sample, because then the sample measurement device will be able to use the oxygen electrode of Amano to measure another analyte, such as glucose or toxins or metabolic substrates. However, although in the working electrode, a reagent (active layer 6 adopted from McAleer Figures 4a and 4b) would be applied to a surface of the electrode unit and covered with a protective film (8 in McAleer Figure 4a or 11 in Figure 4b), the reference electrode would not be covered with a protective film (see McAleer Figures 4a and 4b. Note: “The sensing region 7 comprises an active layer 6, counter electrode 3 and reference electrode 4. The counter electrode 3 and reference electrode 4 may be combined as shown or may be provided as separate electrodes.” See McAleer col. 4:2-5.).
JP 2021-185850 A, based on an English language translation obtained by the U.S. Examiner, does not seem to disclose having the surface of the reference electrode be covered with a protective film, only the reagent on the working electrode is covered with a protective film. See paragraphs [0016], [0013], and [0031]. In any event, it seems that even if the surface of the reference electrode were to be covered with a protective film, so would the surface of the counter electrode.
f) claims 11-13 depend directly or indirectly from allowable claim 10.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER STEPHAN NOGUEROLA whose telephone number is (571)272-1343. The examiner can normally be reached on Monday - Friday 9:00AM-5:30 PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Luan Van can be reached on 571 272-8521. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ALEXANDER S NOGUEROLA/ Primary Examiner, Art Unit 1795
1 Note that in the Figure 23 embodiment immersion elecrode22a is used together with working electrode 21a. See paragraph [0103].
2 Note that in the Figure 23 embodiment immersion elecrode22a is used together with working electrode 21a. See paragraph [0103].
3 Note that the Examiner understands the underlined limitation to mean -- in the reference electrode, its surface is covered with a protective film, . . . – or -- in the reference electrode, its surface within the electrode unit is covered with a protective film, . . . --