`
`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
`
`05/01/2013
`
`WENDEROTH,L1ND&p0NACK LLP.
`1030 15th Street, NW.
`Suite 400 East
`
`Washington, DC 20005-1503
`
`ROSENWALD, STEVEN ERIC
`ART UNIT
`PAPER NUMBER
`
`1759
`
`
`
`NOT *ICATION DATE
`
`DELIVERY MODE
`
`05/01/2013
`
`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 Inventorto File)
`Office Action Summary
`
`1759STEVEN ROSENWALD first“
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE 3 MONTH(S) OR THIRTY (30) DAYS,
`WHICHEVER IS LONGER, FROM THE MAILING DATE OF THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR 1.136(a).
`In no event however may a reply be timely filed
`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).
`
`-
`-
`
`Status
`
`1)IXI Responsive to communication(s) filed on 29 July 2010.
`[I A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`2b)lX| This action is non-final.
`a)I:| 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)|:I Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under EX parte Quay/e, 1935 CD. 11, 453 O.G. 213.
`
`Disposition of Claims
`5)|XI Claim(s) 26-50 is/are pending in the application.
`5a) Of the above claim(s) 28-30 and 43-45 is/are withdrawn from consideration.
`6)|:l Claim(s) _ is/are allowed.
`
`7)IZ| Claim(s) 26 27 31-42 and 46-50 is/are rejected.
`8)I:I Claim(s)_ is/are objected to.
`
`9)|:l Claim((s)
`are subject to restriction and/or election requirement.
`* If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway program at a
`
`participating intellectual property office for the corresponding application. For more information, please see
`htt
`://www.usoto. ov/ atentS/init events"
`
`
`
`h/index.‘s or send an inquiry to PF"I-Ifeedback{<‘buspto.qov.
`
`Application Papers
`
`10)I:I The specification is objected to by the Examiner.
`11)|:I 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)IZI Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`
`b)I:I Some * c)I:I None of the:
`a)le AII
`1.I:I Certified copies of the priority documents have been received.
`2.I:I Certified copies of the priority documents have been received in Application No.
`3.|:I 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.
`
`Interim copies:
`
`a)|:l AII
`
`b)I:I Some
`
`c)I:I None of the:
`
`Interim copies of the priority documents have been received.
`
`Attachment(s)
`
`1) E Notice of References Cited (PTO-892)
`
`3) I] Interview Summary (PTO-413)
`
`Paper NOISIIMa” Date' —
`PTO/SB/08
`t
`St t
`I
`D'
`t'
`f
`2 IXI I
`
`4) I:I Other:
`a emen (s)(
`Isc osure
`n orma Ion
`)
`)
`Paper No(s)/Mai| Date 7/29/2010 6/18/2012 12/03/2012.
`
`US. Patent and Trademark Office
`PTOL-326 (Rev. 03-13)
`
`Part of Paper No./Mai| Date 20130417
`
`Office Action Summary
`
`

`

`Application/Control Number: 12/865,243
`
`Page 2
`
`Art Unit: 1759
`
`DETAILED ACTION
`
`Claims 26-50 are presented for examination.
`
`Election/Restrictions
`
`Applicant’s election of invention I, claims 26, 27, 31 -42, and 46-50 in the reply
`
`filed on 27 December 2012 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 § 818.03(a)).
`
`Claims 28-30 and 43-45 are currently withdrawn. Examination proceeds on
`
`claims 26, 27, 31 -42, and 46-50.
`
`Claim Objections
`
`Claims 27 and 42 are objected to because of the following informalities: Claim
`
`27 recites the limitation “apply a voltage that is ‘higher’ than the certain level“ in line 3,
`
`and claim 42 recites the limitation “a voltage that is ‘higher’ is applied” in lines 23
`
`Examiner notes that -O.1 V is "higher" than -O.2 V, while -O.2 V is of greater magnitude
`
`than -O.1 V. Appropriate correction is required.
`
`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.
`
`

`

`Application/Control Number: 12/865,243
`
`Page 3
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`Art Unit: 1759
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`1.
`
`Claims 26, 27, 31-36, 37-42, and 46-50 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 pre-AIA the applicant regards as the invention.
`
`Claim 26 recites the limitation “two kinds of second voltage” in line 7. Voltage is
`
`the difference in charge between two electrodes and can be expressed mathematically
`
`as V=iR (voltage equals current times resistance). It is unclear how there can be
`
`another "kind" of voltage. For examination purposes, the limitation will be considered to
`
`be met by two different voltages (potentials), or two different voltage wave forms.
`
`Claims 27, 31 -36, 37-40 are rejected due to their dependency from, and
`
`therefore containing all of the limitations of, claim 26.
`
`Claim 31 recites the limitation "the first voltages" in lines 3 and 6. There is
`
`insufficient antecedent basis for this limitation in the claim.
`
`Claim 32 recites the limitation "current values measured under voltages of
`
`different level" in lines 3-4. It is unclear if the voltages of different level are the first and
`
`one of the second voltage applications, or two voltages of the second voltage
`
`application.
`
`Claim 41 recites the limitation “two kinds of second voltage” in line 7. Voltage is
`
`the difference in charge between two electrodes and can be expressed mathematically
`
`as V=iR (voltage equals current times resistance). It is unclear how there can be
`
`another "kind" of voltage. For examination purposes, the limitation will be considered to
`
`be met by two different voltages (potentials), or two different voltage wave forms.
`
`

`

`Application/Control Number: 12/865,243
`
`Page 4
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`Art Unit: 1759
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`Claims 42 and 46-50 are rejected due to their dependency from, and therefore
`
`containing all of the limitations of, claim 26.
`
`Claim 41 recites the limitation "the current value" in line 5. There is insufficient
`
`antecedent basis for this limitation in the claim. Claims 42 and 46-50 depend from and
`
`therefore contain all limitations recited in claim 41 and are rejected for the same reason.
`
`Claim 46 recites the limitation “the first voltages” in line 3. There is insufficient
`
`antecedent basis for this limitation in the claim.
`
`Claim 47 recites the limitation "the amount of change per unit of time" in line 2.
`
`There is insufficient antecedent basis for this limitation in the claim.
`
`Claim 48 recites the limitation "the amount of change" in line 2. There is
`
`insufficient antecedent basis for this limitation in the claim.
`
`Claim 49 recites the limitation "the amount of change" in line 2. There is
`
`insufficient antecedent basis for this limitation in the claim.
`
`Claim Rejections - 35 USC § 103
`
`The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all
`
`obviousness rejections set forth in this Office action:
`
`(a) A patent may not be obtained though the invention is not identically disclosed or described as set
`forth in section 102 of this title, if the differences between the subject matter sought to be patented and
`the prior art are such that the subject matter as a whole would have been obvious at the time the
`invention was made to a person having ordinary skill in the art to which said subject matter pertains.
`Patentability shall not be negatived by the manner in which the invention was made.
`
`The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148
`
`USPQ 459 (1966), that are applied for establishing a background for determining
`
`obviousness under 35 U.S.C. 103(a) are summarized as follows:
`
`1.
`
`Determining the scope and contents of the prior art.
`
`

`

`Application/Control Number: 12/865,243
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`Page 5
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`Art Unit: 1759
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`2.
`3.
`4.
`
`Ascertaining the differences between the prior art and the claims at issue.
`Resolving the level of ordinary skill in the pertinent art.
`Considering objective evidence present in the application indicating
`obviousness or nonobviousness.
`
`This application currently names joint inventors.
`
`In considering patentability of
`
`the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of
`
`the various claims was commonly owned at the time any inventions covered therein
`
`were made absent any evidence to the contrary. Applicant is advised of the obligation
`
`under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was
`
`not commonly owned at the time a later invention was made in order for the examiner to
`
`consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g)
`
`prior art under 35 U.S.C. 103(a).
`
`2.
`
`Claims 26, 27, 33-35, 39, 41, and 48 are rejected under 35 U.S.C. 103(a) as
`
`being unpatentable over Davies et al. (U.S. 2005/0109618 A1 , hereinafter ‘618) and
`
`further in view of lkeda et al. (U.S. 6,212,417 B1).
`
`Regarding claim 26, ‘61 8 teaches a measurement device (Title “meter”) for
`
`measuring the concentration of a target substance in a sample deposited on a
`
`biosensor (par. 0017 “measurement of analytes”, par. 0019 “sample placed on a test
`
`strip”) having first and second electrode systems, the measurement device comprising
`
`(claim 1):
`
`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
`
`

`

`Application/Control Number: 12/865,243
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`Page 6
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`Art Unit: 1759
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`applying a first voltage to the first electrode system (par. 0062 potential E1 or E2), and a
`
`second voltage application operation of applying a second voltage to the second
`
`electrode system (par. 0062 potential E1 or E2);
`
`a concentration acquisition component configured to acquire the concentration of
`
`the target substance on the basis of the current value of the first electrode system when
`
`the first voltage is applied (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 the amount of change in current
`
`value of the second electrode system (Abstract, par. 0038-0042, and see 0051 ), but;
`
`‘618 is silent regarding a voltage application component configured to perform a
`
`second voltage application operation of applying at least two kinds of second voltage of
`
`mutually different levels at mutually different timings to the second electrode system and
`
`is therefore silent regarding a correction component configured to 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.
`
`However, lkeda teaches (col. 10 line 9 “glucose sensor”) a measurement device
`
`for measuring the concentration of a target substance in a sample deposited on a
`
`biosensor having first (col. 10 lines 13-14, “500 mV was applied onto the third electrode
`
`7 using the counter electrode 4 as reference”) and second (col. 10 lines 43-44, “500 mV
`
`

`

`Application/Control Number: 12/865,243
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`Page 7
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`Art Unit: 1759
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`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
`
`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 the 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
`
`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 kinds of second voltage 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 "correct the
`
`concentration acquired by the concentration acquisition component on the basis of the
`
`

`

`Application/Control Number: 12/865,243
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`Page 8
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`Art Unit: 1759
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`amount of change in current value of the second electrode system between the at least
`
`two different timings during the second voltage application operation".
`
`Regarding “first” and “second” voltages, lkeda further teaches (col. 5 lines 11-23)
`
`that the voltages applied are result-effective variables dependent on the intereferent and
`
`redox mediator used, and that the timing of measurement of the current is not limited to
`
`the specific ones given in the examples, i.e. "first" and "second" are considered arbitrary
`
`since the correction is made after both measurements have been made.
`
`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 ‘618 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).
`
`Regarding claim 27, ‘618 and further in view of lkeda is relied upon for the
`
`reasons given above in addressing claim 26, and lkeda teaches wherein the first
`
`voltage is 500 mV (Example 6, col. 10 lines 13-14) and the second voltage is 1,300 mV
`
`(Example 6, col. 10 lines 28-33), and it would be obvious to configure the voltage
`
`application component of ‘618 to apply the second voltages taught by lkeda.
`
`Regarding claims 33 and 34, ‘618 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" (considered to read on "correction amounts") and XG and Y are (par.
`
`0050) voltage effect factors for glucose and interfering compounds, respectively, which
`
`

`

`Application/Control Number: 12/865,243
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`Page 9
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`Art Unit: 1759
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`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). ‘618
`
`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”
`
`(the additional limitation recited in claim 34), 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 ‘618 and further in view of lkeda.
`
`Regarding claim 35, ‘618 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 ‘618 and further in view of lkeda teaches the measurement
`
`device according to claim 26.
`
`Regarding claim 39, ‘618 teaches (par. 0026) the target substance is glucose.
`
`Regarding claim 41, ‘618 teaches (Abstract) 3 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 a first voltage to the first electrode system (par. 0062 potential E1 or E2);
`
`

`

`Application/Control Number: 12/865,243
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`Page 10
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`Art Unit: 1759
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`acquiring the concentration of the target substance on the basis of the current
`
`value of the first electrode system in the first voltage application (par. 0017 “analyte
`
`current [...] corresponds to the analyte concentration”, par. 0062 “calculate an analyte
`
`current”);
`
`applying at least two kinds of second voltage of mutually different levels at
`
`mutually different timings to the second electrode system (par. 0062 potential E1 or E2);
`
`and
`
`correcting the concentration on the basis of the amount of change in current
`
`value of the second electrode system (Abstract, par. 0038-0042, and see 0051 ), but;
`
`‘618 is silent regarding a voltage application component configured to perform a
`
`second voltage application operation of applying at least two kinds of second voltage of
`
`mutually different levels at mutually different timings to the second electrode system and
`
`is therefore silent regarding a correction component configured to 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.
`
`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 (col. 10 lines 13-14, “500 mV was applied onto the third electrode 7 using the
`
`counter electrode 4 as reference”) and second (col. 10 lines 43-44, “500 mV was
`
`applied onto the working electrode 2 using the third electrode 7 as reference”) electrode
`
`systems.
`
`

`

`Application/Control Number: 12/865,243
`
`Page 11
`
`Art Unit: 1759
`
`Referring to Ikeda 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
`
`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”.
`
`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 the instantly
`
`recited “at least two kinds of second voltage 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 kinds of second voltage".
`
`

`

`Application/Control Number: 12/865,243
`
`Page 12
`
`Art Unit: 1759
`
`Regarding “first” and “second” voltages, lkeda further teaches (col. 5 lines 11-23)
`
`that the voltages applied are result-effective variables dependent on the intereferent and
`
`redox mediator used, and that the timing of measurement of the current is not limited to
`
`the specific ones given in the examples, i.e. "first" and "second" are considered arbitrary
`
`since the correction is made after both measurements have been made.
`
`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 ‘618 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).
`
`Regarding claim 42, ‘618 and further in view of lkeda is relied upon for the
`
`reasons given above in addressing claim 41, and lkeda teaches wherein the first
`
`voltage is 500 mV (Example 6, col. 10 lines 13-14) and the second voltage is 1,300 mV
`
`(Example 6, col. 10 lines 28-33), and it would be obvious to modify the second voltage
`
`of ‘618 by applying the two second voltages taught by lkeda.
`
`Regarding claim 48, Davies teaches (par. 0051) a particular set of values
`
`calibrated for a particular lot of test strips to account for lot-to-lot variations, and (par.
`
`0052) using the corrected glucose current only when a certain threshold is exceeded”,
`
`which reads on the instantly recited "selecting a correction amount corresponding to the
`
`amount of change from among a plurality of correction amounts.
`
`Regarding claim 49, Davies teaches (par. 0052) using the corrected glucose
`
`current only when a certain threshold is exceeded”, which reads on the instantly recited
`
`

`

`Application/Control Number: 12/865,243
`
`Page 13
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`Art Unit: 1759
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`“selecting an amount of the correction according to the amount of change and the
`
`acquired concentration”.
`
`Regarding claim 50, Davies teaches (par. 0004) the target substance is glucose.
`
`3.
`
`Claims 31 and 46 are rejected under 35 U.S.C. 103(a) as being unpatentable
`
`over ‘618 and further in view of lkeda as applied to claims 26 and 41 above, and further
`
`in view of Gross et al (WO 98/58250).
`
`Regarding claim 31, ‘618 and further in view of lkeda is relied upon for the
`
`reasons given above in discussing claim 26, ‘618 teaches (Abstract) a first potential is
`
`applied to a first working electrode, but ‘618 is silent regarding a certain voltage followed
`
`by a voltage that is lower as the first voltages. lkeda does not cure this deficiency.
`
`However, Gross teaches (Title) methods of calibrating and testing a sensor for in
`
`vivo measurement of an analyte (reads on measuring an amount of substrate) which is
`
`a hydrogen peroxide based biosensor. The reference relies on a first voltage application
`
`that is larger than the second voltage application to ensure there is enough oxygen
`
`present in the sample (Fig. 7 and pg. 28, line 17 to pg. 30, line 20), and the second
`
`(lower) voltage application (50) is used to measure glucose concentration (pg. 29 lines
`
`1-9) which reads on “applying a voltage of a certain level and then apply a voltage that
`
`is lower” and “acquire the concentration of the target substance on the basis of the
`
`current value [...] during application of the lower voltage.
`
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`Art Unit: 1759
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`Further, '618 and further in view of lkeda measures glucose concentration during
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`the first voltage application, and Gross measures glucose concentration during this
`
`voltage application, so this is considered to be the instantly recited first voltage(s).
`
`Therefore, it would have been obvious to a person having ordinary skill in the art
`
`at the time the invention was made to utilize the voltage application scheme and timing
`
`of Gross as the first voltages of ‘618 and further in view of Ikeda in order to ensure that
`
`the sample has sufficient oxygen and sufficient time to enable an enzymatic reaction to
`
`occur for generating the hydrogen peroxide, and it would be obvious to a person having
`
`ordinary skill in the art at the time of invention to configure the concentration acquisition
`
`component to do so.
`
`Regarding claim 46, ‘618 and further in view of Ikeda is relied upon for the
`
`reasons given above in discussing claim 41, ‘618 teaches (Abstract) 3 first potential is
`
`applied to a first working electrode, but ‘618 is silent regarding a certain voltage followed
`
`by a voltage that is lower as the first voltages. lkeda does not cure this deficiency.
`
`However, Gross teaches (Title) methods of calibrating and testing a sensor for in
`
`vivo measurement of an analyte (reads on measuring an amount of substrate) which is
`
`a hydrogen peroxide based biosensor. The reference relies on a first voltage application
`
`that is larger than the second voltage application to ensure there is enough oxygen
`
`present in the sample (Fig. 7 and pg. 28, line 17 to pg. 30, line 20), and the second
`
`(lower) voltage application (50) is used to measure glucose concentration (pg. 29 lines
`
`1-9) which reads on “a voltage of a certain level is applied, after which a voltage that is
`
`

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`Art Unit: 1759
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`lower is applied” and “the concentration of the target substance is acquired on the basis
`
`of the current value [...] during application of the lower voltage.”
`
`Further, '618 and further in view of lkeda measures glucose concentration during
`
`the first voltage application, and Gross measures glucose concentration during this
`
`voltage application, so this is considered to be the instantly recited first voltage(s).
`
`Therefore, it would have been obvious to a person having ordinary skill in the art
`
`at the time the invention was made to utilize the voltage application scheme and timing
`
`of Gross as the first voltages of ‘618 and further in view of lkeda in order to ensure that
`
`the sample has sufficient oxygen and sufficient time to enable an enzymatic reaction to
`
`occur for generating the hydrogen peroxide.
`
`4.
`
`Claim 32 and 47 are rejected under 35 U.S.C. 103(a) as being unpatentable over
`
`‘618 and further in view of lkeda as applied to claim 26 above, and further in view of
`
`Pottgen et al. (U.S. 6,153,069). Bard and Faulkner (Electrochemical Methods, 1980,
`
`John Wiley and Sons, pp. 136-141) is provided as an evidentiary reference.
`
`Regarding claim 32, ‘618 and further in view of lkeda teaches correction on the
`
`basis of the amount of change in current value measured under voltages of different
`
`level as discussed above in addressing claims 26 and 27, but does not explicitly teach
`
`measurement of the amount of change per unit time.
`
`However, Pottgen teaches (Title) apparatus for amperometric diagnostic analysis
`
`(reads on measurement device) wherein (col. 3 lines 12-39, and see Figs. 7 and 11)
`
`chronoamperometry is used to measure glucose concentration in a sample by
`
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`Art Unit: 1759
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`measurement of a diffusion controlled current at one or more accurately specified times
`
`(col. 3 lines 20-22). Further, single and double-step voltage chronoamperometry are
`
`considered to be voltage application techniques that would have been well known to a
`
`person of ordinary skill in the art at the time of invention (see Bard and Faulkner, a copy
`
`is provided with this office action), so it would have been obvious to provide voltages of
`
`different level.
`
`Therefore, it would have been obvious to a person having ordinary skill in the art
`
`at the time the invention was made to provide the chronoamperometry (measurement of
`
`a diffusion controlled current at one or more accurately specified times) of Pottgen as
`
`the (lkeda col. 10 lines 47-54) measuring the current across the counter and the third
`
`electrode of ‘618 and further in view of lkeda in order to measure current that is
`
`proportional analyte sample as taught by Pottgen (col. 3 lines 36-38) and as a known
`
`means of measuring analyte concentration (see Bard and Faulkner) with a reasonable
`
`expectation of success.
`
`Regarding claim 47, ‘618 and further in view of lkeda teaches correction on the
`
`basis of the amount of change in current value measured under voltages of different
`
`level as discussed above in addressing claims 41 and 42, but does not explicitly teach
`
`measurement of the amount of change per unit time.
`
`However, Pottgen teaches (Title) apparatus for amperometric diagnostic analysis
`
`(reads on measurement device) wherein (col. 3 lines 12-39, and see Figs. 7 and 11)
`
`chronoamperometry is the method used to measure glucose concentration in a sample
`
`by measurement of a diffusion controlled current at one or more accurately specified
`
`

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`Application/Control Number: 12/865,243
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`Art Unit: 1759
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`times (col. 3 lines 20-22). Further, single and double-step voltage chronoamperometry
`
`are considered to be voltage application techniques that would have been well known to
`
`a person of ordinary skill in the art at the time of invention (see Bard and Faulkner, a
`
`copy is provided with this office action), so it would have been obvious to provide
`
`voltages of different level.
`
`Therefore, it would have been obvious to a person having ordinary skill in the art
`
`at the time the invention was made to provide the chronoamperometry (measurement of
`
`a diffusion controlled current at one or more accurately specified times) of Pottgen as
`
`the (lkeda col. 10 lines 47-54) measuring the current across the counter and the third
`
`electrode of ‘618 and further in view of lkeda in order to measure current that is
`
`proportional analyte sample as taught by Pottgen (col. 3 lines 36-38) and as a known
`
`means of measuring analyte concentration (see Bard and Faulkner) with a reasonable
`
`expectation of success.
`
`5.
`
`Claims 36, 37, and 40 are rejected under 35 U.S.C. 103(a) as being
`
`unpatentable over ‘61 8 and further in view of lkeda as applied to claim