`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria1 Virginia 22313- 1450
`wwwusptogov
`
`APPLICATION NO.
`
`
`
`
`
` F ING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`
`
`
`
`CONF {MATION NO.
`
`12/865,243
`
`07/29/2010
`
`Toshifumi Nakamura
`
`201070916A
`
`1478
`
`52349
`
`7590
`
`12/31/2013
`
`WENDEROTH,L1ND&pONACK L112.
`1030 15th Street, NW.
`Suite 400 East
`
`Washington, DC 20005-1503
`
`ROSENWALD, STEVEN ERIC
`ART UNIT
`PAPER NUMBER
`
`1759
`
`
`
`NOT *ICATION DATE
`
`DELIVERY MODE
`
`12/31/2013
`
`ELECTRONIC
`
`Please find below and/0r attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`Notice of the Office communication was sent electronically on above—indicated "Notification Date" to the
`following e—mail address(es):
`ddalecki @wenderoth.com
`eoa@ wenderoth.com
`
`PTOL—90A (Rev. 04/07)
`
`

`

`
`
`Applicant(s)
`Application No.
` 12/865,243 NAKAMURA ET AL.
`
`Examiner
`Art Unit
`AIA (First Inventor to File)
`Office Action Summary
`
`1759STEVEN ROSENWALD [SENS
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
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`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE 3 MONTHS FROM THE MAILING DATE OF
`THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR1. 136( a).
`after SIX () MONTHS from the mailing date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.
`-
`- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1 .704(b).
`
`In no event, however, may a reply be timely filed
`
`Status
`
`1)IZI Responsive to communication(s) filed on 01 October 2013.
`El A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`2b)|:l This action is non-final.
`2a)|Z| This action is FINAL.
`3)I:I An election was made by the applicant in response to a restriction requirement set forth during the interview on
`
`; the restriction requirement and election have been incorporated into this action.
`
`4)|:| Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
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`closed in accordance with the practice under Exparte Quay/e, 1935 CD. 11, 453 O.G. 213.
`
`Disposition of Claims*
`
`5)IZI Claim(s) 26 27 31 32 35-47 and 50-54 is/are pending in the application.
`5a) Of the above claim(s)
`is/are withdrawn from consideration.
`
`is/are allowed.
`6)I:I Claim(s)
`
`7)|Z| Claim(s) 26 2731 32 35-47 and 50-54 is/are rejected.
`
`8)|:I Claim(s)_ is/are objected to.
`* If any)claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway program at a
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`()
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`are subject to restriction and/or election requirement.
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`participating intellectual property office for the corresponding application. For more information, please see
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`:/'/\WNI.LIsoto. ovI’ atentS/init events/
`hI/index.‘s orsend an inquiryto PPI-iieedback{®usgto.00v.
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`htt
`
`Application Papers
`
`10)I:l The specification is objected to by the Examiner.
`11)I:l The drawing(s) filed on
`is/are: a)I:I accepted or b)I:I objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`
`Priority under 35 U.S.C. § 119
`
`12)I:| Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`
`a)I:l All
`
`b)|:l Some” c)I:l None of the:
`
`1.I:I Certified copies of the priority documents have been received.
`2.|:l Certified copies of the priority documents have been received in Application No.
`3.|:| Copies of the certified copies of the priority documents have been received in this National Stage
`
`application from the International Bureau (PCT Rule 17.2(a)).
`** See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`
`3) D Interview Summary (PTO-413)
`1) E Notice of References Cited (PTO-892)
`Paper No(s)/Mai| Date.
`.
`.
`4) I:I Other'
`2) I] InformatIon DIsclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mai| Date
`US. Patent and Trademark Office
`PTOL—326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mai| Date 20131217
`
`

`

`Application/Control Number: 12/865,243
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`Page 2
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`Art Unit: 1759
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`DETAILED ACTION
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`The present application is being examined under the pre-AlA first to invent
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`provisions.
`
`Response to Amendment
`
`This is a final office action in response to applicant's arguments and remarks filed
`
`on 01 October 2013. Claims 26, 27, 31, 32, 35-42, 46, 47, and 50-54 are pending in the
`
`application. Claims 28-30, 33, 34, 43-45, 48, and 49 have been cancelled. Claims 28-30
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`and 43-45 were previously withdrawn.
`
`Status of Objections and Rejections
`
`The objection to the claims has been withdrawn in view of Applicant's
`
`amendment.
`
`The rejection(s) of claims 33, 34, 48, and 49 is obviated by Applicant's
`
`cancellation.
`
`The rejection of claims 26, 27, 31, 32, 35-42, 46, 47, and 50 under 35 USC 112,
`
`second paragraph is withdrawn in view of Applicant's amendment.
`
`All rejections from the previous office action are withdrawn in view of Applicant's
`
`amendment.
`
`New grounds of rejection under 35 U.S.C. 103(a) are necessitated by the
`
`amendments.
`
`Claim Rejections - 35 USC § 1 12
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`The following is a quotation of 35 U.S.C. 112(b):
`
`

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`Application/Control Number: 12/865,243
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`Page 3
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`Art Unit: 1759
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`(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.
`
`1.
`
`Claim 51 is 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 pre-AIA the applicant regards
`
`as the invention.
`
`Claim 51 recites the limitation "the concentration acquisition" in lines 3 and 7.
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`There is insufficient antecedent basis for these limitations in the claim. Examination will
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`proceed with the limitation interpreted as "the concentration acquisition component".
`
`Claim Rejections - 35 USC § 103
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`The text of those sections of Title 35, U.S. Code not included in this action can
`
`be found in a prior Office action.
`
`2.
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`Claims 26, 27, 31, 35, 39, 41, 51, 52, and 54 are rejected under 35 U.S.C. 103(a)
`
`as being unpatentable over Davies et al. (U.S. 2005/0109618 A1) and further in view of
`
`lkeda et al. (U.S. 6,212,417 B1).
`
`Regarding claim 26, Davies teaches a measurement device (Title “meter”,
`
`“electrochemical sensor”) for measuring the concentration of a target substance in a
`
`sample deposited on a biosensor (par. 0017 “measurement of analytes”, par. 0019
`
`

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`Application/Control Number: 12/865,243
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`Page 4
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`Art Unit: 1759
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`“sample placed on a test strip”) having first and second electrode systems (claim 1), the
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`measurement device comprising:
`
`a mounting component configured to be mounted with the biosensor (par. 0062,
`
`“meter interfacing with a test strip”, “connector”);
`
`a voltage application component (par. 0062, “voltage source”) configured to
`
`perform a first voltage application operation of applying a voltage to the first electrode
`
`system (par. 0062 potential E1), and a second voltage application operation of applying
`
`a second voltage to the second electrode system (par. 0062 potential E2);
`
`a concentration acquisition component configured to acquire the concentration of
`
`the target substance on the basis of a current value of the first electrode system when
`
`the voltage is applied to the first electrode system (par. 0006, par. 0062 “E1 [...] may be
`
`used to calculate an analyte current”, par. 0017 “the analyte current [...] corresponds to
`
`the analyte concentration”, par. 0051 “electronics”), and;
`
`a correction component configured to correct the concentration acquired by the
`
`concentration acquisition component on the basis of an amount of a current value of the
`
`second electrode system (Abstract, par. 0038-0042, and see 0051 ).
`
`Davies is silent regarding a voltage application component configured to perform
`
`a second voltage application operation of applying two different voltages of mutually
`
`different levels at mutual/y different timings to the second electrode system and is
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`therefore silent regarding a correction component configured to correct the
`
`concentration acquired by the concentration acquisition component on the basis of the
`
`

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`Application/Control Number: 12/865,243
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`Page 5
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`Art Unit: 1759
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`amount of change in current value of the second electrode system between the two
`
`different timings during the second voltage application operation.
`
`However, lkeda teaches a measurement device (col. 10 line 9 “glucose sensor”)
`
`for measuring the concentration of a target substance in a sample deposited on a
`
`biosensor (col. 10 lines 14-17) having application of a voltage to a first electrode system
`
`(electrodes 2 and 7; col. 10 lines 43-44, “500 mV was applied onto the working
`
`electrode 2 using the third electrode 7 as reference”) and application of a voltage to a
`
`second electrode system (electrodes 4 and 7; col. 10 lines 13-14, “500 mV was applied
`
`onto the third electrode 7 using the counter electrode 4 as reference”) and at a different
`
`time application of a different voltage to the second electrode system (electrodes 4 and
`
`7; col. 10 lines 28-34).
`
`Referring to lkeda Example 6 (col. 10), the reference teaches (col. 10 lines 43-
`
`44) “500 mV was applied onto the working electrode 2 using the third electrode 7 as
`
`reference”, which is considered to read on a voltage application to the first electrode
`
`system, (col. 10 lines 45-50) measurement of current between counter electrode 4 and
`
`working electrode 2, and (col. 7 lines 43-60) the amount of current between counter
`
`electrode 4 and working electrode 2 is proportional to glucose plus interferents (e.g.
`
`ascorbic acid), which reads on the instantly recited “acquir(ing) the concentration of the
`
`target substance on the basis of a current value of the first electrode system when the
`
`first voltage is applied”.
`
`lkeda also teaches (Example 6, col. 10 lines 13-14) "500 mV was applied onto
`
`the third electrode 7 using the counter electrode 4 as reference, followed by (Example
`
`

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`Application/Control Number: 12/865,243
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`Page 6
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`Art Unit: 1759
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`6, col. 10 lines 28-33) changing the voltage across third electrode 7 using the counter
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`electrode 4 as reference to -1,300 mV, which is considered to read on the instantly
`
`recited “two different voltages of mutually different levels at mutually different timings to
`
`the second electrode system”, and (col. 10 lines 47-54) measuring the current across
`
`the counter (4) and the third electrode (7) reflects the concentration of interferents (e.g.
`
`ascorbic acid and oxygen) which is used to correct the glucose concentration
`
`measurement (between electrodes 2 and 7), which is considered to read on the
`
`instantly recited "correct the concentration acquired by the concentration acquisition
`
`component on the basis of the amount of change in current value of the second
`
`electrode system between the at least two different timings during the second voltage
`
`application operation".
`
`Therefore, it would have been obvious to a person having ordinary skill in the art
`
`at the time the invention was made to modify the second voltage configuration of the
`
`meter of Davies to provide the first and second voltage applications of lkeda in order to
`
`provide a precise glucose concentration from which the influence of ascorbic acid and
`
`oxygen has been excluded as taught by lkeda (col. 10 lines 47-54), so Davies and
`
`further in view of lkeda teaches the single voltage application to the first set of
`
`electrodes and application of two mutually exclusive voltages at mutually exclusive
`
`times to the second set of electrodes and it would be obvious to substitute these values
`
`into the memory taught by Davies as a table.
`
`Addressing the remaining limitations, Davies further teaches (par. 0051) the
`
`meter has “a particular set of values for XG and Y” in its memory, where XG and Y
`
`

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`Application/Control Number: 12/865,243
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`Page 7
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`Art Unit: 1759
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`"would account for test strip lot-to-lot variations" (considered to read on "correction
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`amounts", where multiple values for XG and Y, stored in memory to account of multiple
`
`lots of test strips, is construed as the instantly recited “table”) and XG and Y are (par.
`
`0050) voltage effect factors for glucose and interfering compounds, respectively, which
`
`is also considered to read on "correction amounts", and (par. 0052) the corrected
`
`glucose current may be used by the meter only when (reads on “correction amount
`
`selector”) a certain threshold (“amount of change”) is exceeded (also see par. 0054,
`
`where selection of none of the correction amounts is considered to be a selection).
`
`Davies further teaches (par. 0052) that if W2 (par. 0044 “first current”) is about 10% or
`
`greater (reads on “select”) than W1 (par. 0045 “second current”) the meter would use eq
`
`8 (see par. 0049, the equation includes XG and Y, which reads on they are “selected”),
`
`which reads on “and the concentration acquired by the concentration acquisition
`
`component”, and it would be obvious to configure the meter of Davies to apply the
`
`selection to the change in current value during the second voltage application operation
`
`of Davies and further in view of lkeda.
`
`Regarding claim 27, Davies and further in view of lkeda is relied upon for the
`
`reasons given above in addressing claim 26, and lkeda teaches a voltage application
`
`component applying voltage to the second electrode system in a range of -1,300 mV to
`
`500 mV to (Example 6, col. 10 lines 28-33; -1,300 mV, Example 6, col. 10 lines 13-14;
`
`500 mV), as well as application of two different voltages to the second electrode
`
`system, so it is obvious that the voltage application component of lkeda could be
`
`

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`Application/Control Number: 12/865,243
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`Page 8
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`Art Unit: 1759
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`configured to apply the instantly recited first positive voltage to the second electrode
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`system and then a second positive voltage to the second electrode system as the two
`
`different voltages, where the second positive voltage has a magnitude greater than the
`
`first positive voltage. See MPEP 2114 l and II; apparatus claims must be structurally
`
`distinguishable from the prior art, and a manner of operating a device does not
`
`differentiate an apparatus claim from the prior art.
`
`Regarding claim 31, Davies and further in view of lkeda is relied upon for the
`
`reasons given above in addressing claim 26, Davies teaches a concentration acquisition
`
`component as discussed above in addressing claim 26, and lkeda teaches a voltage
`
`application component applying voltage of 500 mV to the first electrode system (col. 6,
`
`lines 49-50) and applying voltage to the second electrode system in a range of -1,300
`
`mV to 500 mV to (Example 6, col. 10 lines 28-33; -1,300 mV, Example 6, col. 10 lines
`
`13-14; 500 mV), as well as application of two different voltages to the second electrode
`
`system, so it is obvious that the voltage application component of lkeda could be
`
`configured to apply the instantly recited positive voltage to the first electrode system for
`
`preprocessing (intended use, not a positive recitation of structure), and then apply the
`
`voltage to the first electrode system to perform the first voltage application operation
`
`(intended use, not a positive recitation of structure), where the voltage applied to the
`
`first electrode system to perform the first voltage application operation is a positive
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`voltage that has a magnitude less than the positive voltage applied to the first electrode
`
`system for preprocessing, and
`
`

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`Application/Control Number: 12/865,243
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`Page 9
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`Art Unit: 1759
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`the concentration acquisition component is configured to acquire the
`
`concentration of the target substance on the basis of the current value of the first
`
`electrode system during application of the voltage applied to the electrode system to
`
`perform the first voltage application operation is taught by Davies (par. 0006, par. 0062
`
`“E1 [...] may be used to calculate an analyte current”, par. 0017 “the analyte current [...]
`
`corresponds to the analyte concentration”, par. 0051 “electronics”).
`
`Regarding claim 35, Davies teaches a biosensor (par. 0017 “measurement of
`
`analytes”, par. 0019 “sample placed on a test strip”) having first and second electrode
`
`systems (claim 1) and Davies and further in view of lkeda teaches the measurement
`
`device according to claim 26.
`
`Regarding claim 39, Davies teaches (par. 0026) the target substance is glucose.
`
`Regarding claim 41, Davies teaches (Abstract) a concentration measurement
`
`method used in a measurement device for measuring the concentration of a target
`
`substance in a sample deposited on a biosensor having first and second electrode
`
`systems, the method comprising:
`
`applying, as a first voltage application operation, a voltage to the first electrode
`
`system (par. 0062 potential E1);
`
`acquiring the concentration of the target substance on the basis of a current
`
`value of the first electrode system when the voltage is applied to the first electrode
`
`system (par. 0017 “analyte current [...] corresponds to the analyte concentration”, par.
`
`0062 “calculate an analyte current”);
`
`

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`Application/Control Number: 12/865,243
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`Page 10
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`Art Unit: 1759
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`applying, as a second voltage application operation, a voltage to the second
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`electrode system (par. 0062 potential E2, not the instantly recited “at least two different
`
`voltage of mutually different levels at mutually different timings“); and
`
`correcting the concentration on the basis of the amount of current value of the
`
`second electrode system (Abstract, par. 0038-0042, and see 0051), but;
`
`Davies is silent regarding applying, as a second voltage application operation, at
`
`least two different voltages of mutually different levels at mutually different timings to the
`
`second electrode system and is therefore silent regarding correcting the concentration
`
`on the basis of an amount of change in a current value of the second electrode system
`
`between the at least two different timings during the second voltage application
`
`operation.
`
`However, lkeda teaches (col. 10 line 9 “glucose sensor”) a method for measuring
`
`the concentration of a target substance in a sample deposited on a biosensor having
`
`first (electrodes 7 and 4; col. 10 lines 13-14, “500 mV was applied onto the third
`
`electrode 7 using the counter electrode 4 as reference”) and second (electrodes 2 and
`
`7; col. 10 lines 43-44, “500 mV was applied onto the working electrode 2 using the third
`
`electrode 7 as reference”) electrode systems.
`
`Referring to lkeda Example 6 (col. 10), the reference teaches (col. 10 lines 43-
`
`44) “500 mV was applied onto the working electrode 2 using the third electrode 7 as
`
`reference”, which is considered to read on the first voltage application operation, (col.
`
`10 lines 45-50) measurement of current between counter electrode 4 and working
`
`electrode 2, and (col. 7 lines 43-60) the amount of current between counter electrode 4
`
`

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`Application/Control Number: 12/865,243
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`Page 11
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`Art Unit: 1759
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`and working electrode 2 is proportional to glucose plus interferents (e.g. ascorbic acid),
`
`which reads on the instantly recited “acquiring the concentration of the target substance
`
`on the basis of the current value of the first electrode system in the first voltage
`
`application”.
`
`lkeda also teaches (Example 6, col. 10 lines 13-14) "500 mV was applied onto
`
`the third electrode 7 using the counter electrode 4 as reference, followed by (Example
`
`6, col. 10 lines 28-33) changing the voltage across third electrode 7 using the counter
`
`electrode 4 as reference to 1,300 mV, which is considered to read on the instantly
`
`recited “at least two different voltages of mutually different levels at mutually different
`
`timings to the second electrode system”, and (col. 10 lines 47-54) measuring the current
`
`across the counter and the third electrode reflects the concentration of interferents (e.g.
`
`ascorbic acid and oxygen) is used to correct the glucose concentration measurement,
`
`which is considered to read on the instantly recited "correcting the concentration on the
`
`basis of the amount of change in current value of the second electrode system between
`
`the at least two different timings during the application of the at least two different
`
`voHagesh
`
`Therefore, it would have been obvious to a person having ordinary skill in the art
`
`at the time the invention was made to modify the second voltage of Davies with the first
`
`and second voltage applications of lkeda in order to provide a precise glucose
`
`concentration from which the influence of ascorbic acid and oxygen has been excluded
`
`as taught by lkeda (col. 10 lines 47-54).
`
`

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`Application/Control Number: 12/865,243
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`Page 12
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`Art Unit: 1759
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`Regarding claim 50, Davies teaches (par. 0004) the target substance is glucose.
`
`Regarding claim 51, Davies and further in view of Ikeda is relied upon for the
`
`reasons given above in discussing claim 26, and the combination of references teaches
`
`all of the structure recited in claim 51 (concentration acquisition component, second
`
`electrode system, correction amount selector, memory), as discussed in addressing
`
`claim 26, so the device of Davies and further in view of Ikeda is considered to obviously
`
`be capable of providing the function and use limitations recited. See MPEP 2114.
`
`Furthermore, Ikeda also teaches (Example 6, col. 10 lines 13-14) "500 mV was
`
`applied onto the third electrode 7 using the counter electrode 4 as reference, followed
`
`by (Example 6, col. 10 lines 28-33) changing the voltage across third electrode 7 using
`
`the counter electrode 4 as reference to -1,300 mV, which is considered to read on “two
`
`different voltages of mutually different levels at mutually different timings to the second
`
`electrode system” recited in claim 26, and (col. 10 lines 47-54) measuring the current
`
`across the counter (4) and the third electrode (7) reflects the concentration of
`
`interferents (e.g. ascorbic acid and oxygen) which is used to correct the glucose
`
`concentration measurement (between electrodes 2 and 7), which is considered to read
`
`on the instantly recited "the correction amounts are associated with the amount of
`
`change, the concentration acquired by the concentration acquisition and a current value
`
`of the second electrode system during the second voltage application operation".
`
`Davies teaches (par. 0051) the meter has “a particular set of values for XG and Y”
`
`in its memory, where XG and Y "would account for test strip lot-to-lot variations"
`
`

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`Application/Control Number: 12/865,243
`
`Page 13
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`Art Unit: 1759
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`(considered to read on "correction amounts", where multiple values for XG and Y, stored
`
`in memory to account of multiple lots of test strips, is construed as the instantly recited
`
`“table”) and XG and Y are (par. 0050) voltage effect factors for glucose and interfering
`
`compounds, respectively, which is also considered to read on "correction amounts", and
`
`(par. 0052) the corrected glucose current may be used by the meter only when (reads
`
`on “correction amount selector”) a certain threshold (“amount of change”) is exceeded
`
`(also see par. 0054, where selection of none of the correction amounts is considered to
`
`be a selection). Davies further teaches (par. 0052) that if W2 (par. 0044 “first current”) is
`
`about 10% or greater (reads on “select”) than W1 (par. 0045 “second current”) the meter
`
`would use eq 8 (see par. 0049, the equation includes XG and Y, which reads on they are
`
`“selected”), which reads on “the concentration acquired by the concentration acquisition
`
`component”, and it would be obvious to configure the meter to apply the selection to
`
`the change in current value during the second voltage application operation of Davies
`
`and further in view of lkeda (see lkeda col. 10, lines 34-37).
`
`Regarding claim 53, Davies and further in view of lkeda is relied upon for the
`
`reasons given above in discussing claim 41 and lkeda teaches (Example 6, col. 10 lines
`
`13-14) "500 mV was applied onto the third electrode 7 using the counter electrode 4 as
`
`reference, followed by (Example 6, col. 10 lines 28-33) changing the voltage across
`
`third electrode 7 using the counter electrode 4 as reference to -1,300 mV, which is
`
`considered to read on “applying, as a second voltage application operation, two different
`
`voltages of mutually different levels at mutually different timings to the second electrode
`
`

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`Application/Control Number: 12/865,243
`
`Page 14
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`Art Unit: 1759
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`system” recited in claim 41, and (col. 10 lines 47-54) measuring the current across the
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`counter (4) and the third electrode (7) reflects the concentration of interferents (e.g.
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`ascorbic acid and oxygen) which is used to correct the glucose concentration
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`measurement (between electrodes 2 and 7), which is considered to read on the
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`instantly recited "the correction amounts are associated with the amount of change, the
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`acquired concentration, and a current value of the second electrode system during the
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`second voltage application operation".
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`Further, Davies teaches (par. 0051) the meter has “a particular set of values for
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`XG and Y” in its memory, where XG and Y "would account for test strip lot-to-lot
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`variations" (considered to read on "correction amounts", where multiple values for XG
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`and Y, stored in memory to account of multiple lots of test strips, is construed as the
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`instantly recited “table”) and XG and Y are (par. 0050) voltage effect factors for glucose
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`and interfering compounds, respectively, which is also considered to read on "correction
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`amounts", and (par. 0052) the corrected glucose current may be used by the meter only
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`when (reads on “correction amount is selected”) a certain threshold (“amount of
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`change”) is exceeded (also see par. 0054, where selection of none of the correction
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`amounts is also considered to be a selection). Davies further teaches (par. 0052) that if
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`W2 (par. 0044 “first current”) is about 10% or greater (reads on “select”) than W1 (par.
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`0045 “second current”) the meter would use eq 8 (see par. 0049, the equation includes
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`XG and Y, which reads on they are “selected”), which reads on “the correction amount is
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`selected to be used in the correction from [...] the current value of the second electrode
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`system during the second voltage application”.
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`Page 15
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`Regarding claims 52 and 54, Davies and further in view of Ikeda is relied upon
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`for the reasons given above in discussing claims 26 and 41, and it is considered to be
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`obvious that measurement stops when a measurement, such as at the end of the
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`second voltage application of Ikeda (col. 10, lines 28-41, "the application of potential
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`was stopped"), a final response value is obtained.
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`3.
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`Claim 32 and 47 are rejected under 35 U.S.C. 103(a) as being unpatentable over
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`Davies and further in view of Ikeda as applied to claim 26 above, and further in view of
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`Pottgen et al. (U.S. 6,153,069). Bard and Faulkner (Electrochemical Methods, 1980,
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`John Wiley and Sons, pp. 136-141) is provided as an evidentiary reference.
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`Regarding claim 32, Davies and further in view of Ikeda teaches correction on
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`the basis of the amount of change in current value measured under two different
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`voltages in the second voltage application operation as discussed above in addressing
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`claims 26 and 27, but does not explicitly teach measurement of the amount of change
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`per unit time.
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`However, Pottgen teaches (Title) apparatus for amperometric diagnostic analysis
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`(reads on measurement device) wherein (col. 3 lines 12-39, and see Figs. 7 and 11)
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`chronoamperometry is used to measure glucose concentration in a sample by
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`measurement of a diffusion controlled current at one or more accurately specified times
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`(col. 3 lines 20-22). Further, single and double-step voltage chronoamperometry are
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`considered to be voltage application techniques that would have been well known to a
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`Page 16
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`Art Unit: 1759
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`person of ordinary skill in the art at the time of invention (see Bard and Faulkner, a copy
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`is provided with this office action), so it would have been obvious to provide voltages of
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`different level.
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`Therefore, it would have been obvious to a person having ordinary skill in the art
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`at the time the invention was made to provide the chronoamperometry (measurement of
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`a diffusion controlled current at one or more accurately specified times) of Pottgen as
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`the (lkeda col. 10 lines 47-54) measuring the current across the counter and the third
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`electrode of Davies and further in view of lkeda in order to measure current that is
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`proportional analyte sample as taught by Pottgen (col. 3 lines 36-38) and as a known
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`means of measuring analyte concentration (see Bard and Faulkner) with a reasonable
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`expectation of success.
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`Regarding claim 47, Davies and further in view of lkeda teaches correction on
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`the basis of the amount of change in current value measured under voltages of different
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`level as discussed above in addressing claims 41 and 42, but does not explicitly teach
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`measurement of the amount of change per unit time.
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`However, Pottgen teaches (Title) apparatus for amperometric diagnostic analysis
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`(reads on measurement device) wherein (col. 3 lines 12-39, and see Figs. 7 and 11)
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`chronoamperometry is the method used to measure glucose concentration in a sample
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`by measurement of a diffusion controlled current at one or more accurately specified
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`times (col. 3 lines 20-22). Further, single and double-step voltage chronoamperometry
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`are considered to be voltage application techniques that would have been well known to
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`a person of ordinary skill in the art at the time of invention (see Bard and Faulkner, a
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`

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`Page 17
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`Art Unit: 1759
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`copy is provided with this office action), so it would have been obvious to provide
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`voltages of different level.
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`Therefore, it would have been obvious to a person having ordinary skill in the art
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`at the time the invention was made to provide the chronoamperometry (measurement of
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`a diffusion controlled current at one or more accurately specified times) of Pottgen as
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`the (lkeda col. 10 lines 47-54) measuring the current across the counter and the third
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`electrode of Davies and further in view of lkeda in order to measure current that is
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`proportional analyte sample as taught by Pottgen (col. 3 lines 36-38) and as a known
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`means of measuring analyte concentration (see Bard and Faulkner) with a reasonable
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`expectation of success.
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`4.
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`Claims 36, 37, and 40 are rejected under 35 U.S.C. 103(a) as being
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`unpatentable over Davies and further in view of lkeda as applied to claim 26 above, and
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`further in view of Davies et al. (US. 2005/0139469 A1, hereinafter ‘469).
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`Regarding claim 36, Davies and further in view of lkeda is relied upon for the
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`reasons given above in addressing claim 26, and Davies teaches (par. 0056 and Fig. 1)
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`the first electrode system has a first working electrode (12) and a counter electrode (10,
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`reference electrode reads on counter electrode), the second electrode system has a
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`second working electrode (14) and the counter electrode (10), and the biosensor further
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`has a reagent layer (par. 0055, 0058 Fig.1 at 22) disposed over at least the first working
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`electrode.
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`Davies and further in view of lkeda does not teach another reagent layer that is
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`disposed over the second working electrode and includes a different reagent from that
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`of the reagent layer over the first working electrode.
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`However, ‘469 t