`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria1 Virginia 22313- 1450
`www.uspto.gov
`
`APPLICATION NO.
`
`
`
`
`
` F ING DATE
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`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`
`
`
`
`CONF {MATION NO.
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`13/609,305
`
`09/11/2012
`
`Shoji Miyazaki
`
`55220/1053
`
`2566
`
`1912
`
`7590
`
`09/25/2013
`
`AMSTER,ROTHSTEIN&EBENSTEIN LLP
`90 PARK AVENUE
`NEW YORK, NY 10016
`
`KESSEL, MARIS R
`
`PAPER NUMBER
`
`ART UNIT
`
`1759
`
`
`
`
`NOT *ICATION DATE
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`DELIVERY MODE
`
`09/25/2013
`
`ELECTRONIC
`
`Please find below and/or 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):
`PTODOCKET @ ARELAWCOM
`
`PTOL—90A (Rev. 04/07)
`
`

`

`
`
`Applicant(s)
`Application No.
` 13/609,305 MIYAZAKI ET AL.
`
`Examiner
`Art Unit
`AIA (First Inventor to File)
`Office Action Summary
`
`1759MARIS R. KESSEL its“
`
`-- 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)IZI Responsive to communication(s) filed on 6/4/13.
`El A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
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`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
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`; the restriction requirement and election have been incorporated into this action.
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`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
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`5)IZI Claim(s) 34 35 and 37-42 is/are pending in the application.
`5a) Of the above claim(s)
`is/are withdrawn from consideration.
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`is/are allowed.
`6)I:I Claim(s)
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`7)|Z| Claim(s) 34 35 and 37-42 is/are rejected.
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`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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`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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`:/'/\W¢W.LISI>I‘.0. ovI’ atentS/init events/
`h/index.‘s orsend an inquiryto PPI-iieedback{®usgtc.00v.
`
`hit
`
`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
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`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)
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`1) E Notice of References Cited (PTO-892)
`
`3) D Interview Summary (PTO-413)
`
`Paper N°ISI/Ma" Date' —
`PTO/SB/08
`t
`t
`St
`I
`D'
`I'
`f
`2 IZI I
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`)
`4) I:I Other:
`Isc osure
`n orma Ion
`)
`a emen (s) (
`Paper No(s)/Mai| Date 6/4/13' 9/11/12.
`
`U.S. Patent and Trademark Office
`PTOL—326 (Rev. 08-13)
`
`Part of Paper No./Mai| Date 20130918
`
`Office Action Summary
`
`

`

`Application/Control Number: 13/609,305
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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-AIA first to invent
`provisions.
`
`Response to Amendment
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`This is a final office action in response to applicant's arguments and remarks filed
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`on June 4, 2013. Claims 34, 35 and 37-42 are pending in the application.
`
`Status of Objections and Rejections
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`All rejections from the previous office action are withdrawn in view of Applicant's
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`amendment.
`
`New grounds of rejection under 35 U.S.C. 103(a) are necessitated by the
`
`amendments.
`
`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
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`be found in a prior Office action.
`
`1.
`
`Claims 34 and 35 are rejected under 35 U.S.C. 103(a) as being unpatentable
`
`over White et al. (US 5,405,511) (hereinafter “White”).
`
`Regarding claim 34, White teaches a method of measuring a quantity of a
`
`substrate (col. 4, lns. 36-43), comprising: providing a biosensor to which sample liquid
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`

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`Application/Control Number: 13/609,305
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`Page 3
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`Art Unit: 1759
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`containing a substrate is supplied (sample strip 18, analyte containing fluid sample is
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`placed, col. 3, lns. 14-22); providing a measuring device which includes a temperature
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`measuring unit measuring a temperature inside the measuring device (biosensing meter
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`10 includes a temperature sensor 30, col 3., lns. 27-31); and canceling a process of
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`measuring the quantity of the substrate based on a magnitude of a change of the
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`temperatures measured at the given intervals even if the biosensor is inserted into the
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`measuring device (If Tambiem is not within proper operating limits then the test is aborted,
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`Tambiem is based on difference between Tnew and Told, col. 7, lns. 14-25).
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`White teaches measuring the temperature at given intervals before the testing
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`the analyte sample while the biosensor is inserted (Fig. 4, col. 4, In. 63- col. 5, ln. 5, col.
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`5, In. 65 - col. 6, In. 24, Tnew, Told) but fails to teach measuring the temperature at given
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`intervals before the biosensor is inserted into the measuring device. White teaches that
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`it is undesirable for the user to wait for forty minutes to obtain an accurate glucose
`
`reading (col. 5, lns. 25-27). White teaches that it has been determined that accurage
`
`glucose reading can be obtained by estimating the ambient termparature from a few
`
`temperature reading from the sensor (col. 5, lns. 27-31) and so as not require a user to
`
`wait for two temperature readings to be obtained, the meter is caused to take
`
`temperature readings at periodic intervals even when it is in the off state (col. 5, lns. 39-
`
`42). White teaches that the blood sample is placed in the well once the meter is turned
`
`on (col. 4 lns, 27-36). White teaches taking temp reading for around 10 while the meter
`
`is in the off position (Fig. 4). It would have been obvious to one of ordinary skill in the art
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`at the time the invention was made to modify the method of White to insert the
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`

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`Application/Control Number: 13/609,305
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`Page 4
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`Art Unit: 1759
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`biosensor after the meter has taken several readings in the off position because doing
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`so would cause less waiting and inconvenience to the user.
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`Regarding claim 35, White teaches further comprising: measuring the
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`temperature of the biosensor after the biosensor is inserted into the measuring device
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`(Fig. 4, col. 4, In. 63- col. 5, ln. 5, col. 5, In. 65 - col. 6, In. 24, Tnew, Told). Modified White
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`teaches detecting a temperature change between the temperature measured before the
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`biosensor is inserted into the measuring device and the temperature measured after the
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`biosensor is inserted into the measuring device (Fig. 4, col. 4, In. 63- col. 5, ln. 5, col. 5,
`
`In. 65 - col. 6, In. 24, Tnew, Told); determining, according to the temperature change,
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`whether the quantity of the substrate is measured or not (using Tambiem operating limits
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`to perform temperature correction for glucose measurements, col. 7, lns. 26-30); and
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`stopping measurement of the substrate when the temperature change exceeds a
`
`predetermined threshold (lf Tambiem is not within proper operating limits then the test is
`
`aborted, Tambiem is based on difference between Tnew and Told, col. 7, lns. 14-25).
`
`2.
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`Claim 37 is rejected under 35 U.S.C. 103(a) as being unpatentable over White as
`
`applied to claim 34 above, and further in view of Demmin et al. (US 5,554,273)
`
`(hereinafter "Demmin").
`
`Regarding claim 37, White fails to teach teaches wherein the temperature
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`measuring unit of the measuring device comprises a plurality of temperature measuring
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`sections for measuring values of the temperature inside the measuring device.
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`

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`Application/Control Number: 13/609,305
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`Page 5
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`Art Unit: 1759
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`However, Demmin teaches a method for correcting an output from an electrochemical
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`cell sensor (abstract) wherein the cell includes multiple temperature sensors (col. 14,
`
`lns. 14-17). It would have been obvious to one of ordinary skill in the art at the time the
`
`invention was made to substitute the single sensor as taught by White with the multiple
`
`sensors as taught by Demmin because doing so would increase the accuracy of
`
`temperature readings and compensate for the thermal gradient (col. 14, lns. 14-17).
`
`Regarding claim 38, White fails to teach teaches wherein the temperature
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`measuring unit of the measuring device comprises a plurality of temperature measuring
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`sections for measuring values of the temperature inside the measuring device.
`
`However, Demmin teaches a method for correcting an output from an electrochemical
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`cell sensor (abstract) wherein to assure that the cell is isothermic, the cell includes
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`multiple temperature sensors (col. 14, lns. 14-17). It would have been obvious to one of
`
`ordinary skill in the art at the time the invention was made to substitute the single sensor
`
`as taught by White with the multiple sensors as taught by Demmin because doing so
`
`would increase the accuracy of temperature readings and compensate for the thermal
`
`gradient (col. 14, lns. 14-17).
`
`Regarding claim 39, Modified White teaches using the temperature measured
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`before the biosensor is inserted into the measuring device or the temperature measured
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`after the biosensor is inserted into the measuring device as rejected in claim 34 and
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`selecting from the temperatures measured (Fig. 4, col. 4, In. 63- col. 5, ln. 5, col. 5, ln.
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`

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`Application/Control Number: 13/609,305
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`Page 6
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`Art Unit: 1759
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`65 - col. 6, In. 24, Tnew, Told). Demmin teaches measuring the temperatures by the
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`plurality of temperature measuring sections (col. 14, lns. 14-17).
`
`Regarding claim 40, Modified White teaches using the temperature measured
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`before the biosensor is inserted into the measuring device or the temperature measured
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`after the biosensor is inserted into the measuring device as rejected in claim 34 and
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`selecting from the temperatures measured (Fig. 4, col. 4, In. 63- col. 5, ln. 5, col. 5, In.
`
`65 - col. 6, In. 24, Tnew, Told). Demmin teaches measuring the tempurates by the plurality
`
`of temperature measuring sections (col. 14, lns. 14-17).
`
`3.
`
`Claims 41 and 42 are rejected under 35 U.S.C. 103(a) as being unpatentable
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`over White in view of Demmin as applied to claims 37 and 38 above respectively, and
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`further in view of Wong et al. (US 6,123,827) (hereinafter "Wong”).
`
`Regarding claim 41, Modified Whites teaches wherein the temperature measured
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`before the biosensor is inserted into the measuring device or the temperature measured
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`after the biosensor is inserted into the measuring device as rejected in claim 34.
`
`Demmin teaches measuring temperatures by the plurality of temperature measuring
`
`sections. White fails to teach wherein the temperature measured is an average value of
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`the temperatures measured. However, Wong teaches method for calibrating biosensing
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`such as for glucose concentration through amperometric detection (abstract, col. 1, ln.
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`54-col. 2, lns. 17) like that of White, by correcting outputs by taking temperature
`
`readings wherein the change of temperature is a calibrant and wherein the arithmetic
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`

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`Application/Control Number: 13/609,305
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`Page 7
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`Art Unit: 1759
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`average of the current ambient temperature and the ambient temperature at the time of
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`testing are used for the calculation (col. 9, lns. 9-20). It would have been obvious to one
`
`of ordinary skill in the art the time the invention was made to modify the calculation of
`
`White to include calculating an average as taught by Wong because it was known at the
`
`time of the invention that calculating average can also be used for correction sensor
`
`reading and simple substitution of one known element for another is likely to be obvious
`
`when predictable results are achieved. See KSR International Co. v. Telef/ex Inc., 550
`
`us. _, _, 82 U.S.P.Q.2d 1385, 1395-97 (2007); MPEP 2143 (B).
`
`Regarding claim 42, Modified Whites teaches wherein the temperature measured
`
`before the biosensor is inserted into the measuring device or the temperature measured
`
`after the biosensor is inserted into the measuring device as rejected in claim 34.
`
`Demmin teaches measuring temperatures by the plurality of temperature measuring
`
`sections. White fails to teach wherein the temperature measured is an average value of
`
`the temperatures measured. However, Wong teaches method for calibrating biosensing
`
`such as for glucose concentration through amperometric detection (abstract, col. 1, ln.
`
`54-col. 2, lns. 17) like that of White, by correcting outputs by taking temperature
`
`readings wherein the change of temperature is a calibrant and wherein the arithmetic
`
`average of the current ambient temperature and the ambient temperature at the time of
`
`testing are used for the calculation (col. 9, lns. 9-20). It would have been obvious to one
`
`of ordinary skill in the art the time the invention was made to modify the calculation of
`
`White to include calculating an average as taught by Wong because it was known at the
`
`

`

`Application/Control Number: 13/609,305
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`Page 8
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`Art Unit: 1759
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`time of the invention that calculating average can also be used for correction sensor
`
`reading and simple substitution of one known element for another is likely to be obvious
`
`when predictable results are achieved. See KSR International Co. v. Telef/eX Inc., 550
`
`us. _, _, 82 U.S.P.Q.2d 1385, 1395-97 (2007); MPEP 2143 (B).
`
`Response to Arguments
`
`In the arguments presented on pages 6 and 7 of the amendment, the applicant
`
`argues that the features claim 34 as amended are not disclosed or suggested in the
`
`cited references. Applicant maintains that White does not suggest or disclose that both
`
`T new and T old are measured before the biosensor is inserted in the measuring device
`
`and therefore the cited references do not anticipate or render obvious the presently
`
`claimed invention.
`
`Examiner respectfully disagrees. White teaches measuring the temperature at
`
`given intervals before the testing the analyte sample while the biosensor is inserted
`
`(Fig. 4, col. 4, In. 63- col. 5, ln. 5, col. 5, In. 65 - col. 6, In. 24, Tnew, Told) but fails to teach
`
`measuring the temperature at given intervals before the biosensor is inserted into the
`
`measuring device. White teaches that it is undesirable for the user to wait for forty
`
`minutes to obtain an accurate glucose reading (col. 5, lns. 25-27). White teaches that it
`
`has been determined that accurage glucose reading can be obtained by estimating the
`
`ambient termparature from a few temperature reading from the sensor (col. 5, lns. 27-
`
`31) and so as not require a user to wait for two temperature readings to be obtained, the
`
`

`

`Application/Control Number: 13/609,305
`
`Page 9
`
`Art Unit: 1759
`
`meter is caused to take temperature readings at periodic intervals even when it is in the
`
`off state (col. 5, lns. 39-42). White teaches that the blood sample is placed in the well
`
`once the meter is turned on (col. 4 lns, 27-36). White teaches taking temp reading for
`
`around 10 while the meter is in the off position (Fig. 4). It would have been obvious to
`
`one of ordinary skill in the art at the time the invention was made to modify the method
`
`of White to insert the biosensor after the meter has taken several readings in the off
`
`position because doing so would cause less waiting and inconvenience to the user.
`
`Conclusion
`
`Applicant's amendment necessitated the new ground(s) of rejection presented in
`
`this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP
`
`§ 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37
`
`CFR1.136(a).
`
`A shortened statutory period for reply to this final action is set to expire THREE
`
`MONTHS from the mailing date of this action.
`
`In the event a first reply is filed within
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`TWO MONTHS of the mailing date of this final action and the advisory action is not
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`mailed until after the end of the THREE-MONTH shortened statutory period, then the
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`shortened statutory period will expire on the date the advisory action is mailed, and any
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`extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of
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`the advisory action.
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`In no event, however, will the statutory period for reply expire later
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`than SIX MONTHS from the date of this final action.
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`

`

`Application/Control Number: 13/609,305
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`Page 10
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`Art Unit: 1759
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to MARIS R. KESSEL whose telephone number is
`
`(571 )270-7698. The examiner can normally be reached on Monday through Thursday,
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`8:30 AM. to 6:30 PM.
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
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`supervisor, Luan Van can be reached on (571) 272—-8521. The fax phone number for
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`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
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`published applications may be obtained from either Private PAIR or Public PAIR.
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`Status information for unpublished applications is available through Private PAIR only.
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`For more information about the PAIR system, see http://pair-direct.uspto.gov. Should
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`
`/M. R. K./
`
`M.R.K.
`
`Examiner, Art Unit 1759
`
`/LUAN V VAN/
`
`Supervisory Patent Examiner, Art Unit 1759
`
`