`
`UNITED STATES PATENT AND TRADEMARK OFFICE
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`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
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`APPLICATION NO.
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` F ING DATE
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`FIRST NAMED INVENTOR
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`ATTORNEY DOCKET NO.
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`CONF {MATION NO.
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`13/609,305
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`09/11/2012
`
`Shoji Miyazaki
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`55220/1053
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`2566
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`1912
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`7590
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`02/04/2013
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`AMSTER,ROTHSTEIN&EBENSTEIN LLP
`90 PARK AVENUE
`NEW YORK, NY 10016
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`KESSEL, MARIS R
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`PAPER NUMBER
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`ART UNIT
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`1759
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`NOT *ICATION DATE
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`DELIVERY MODE
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`02/04/2013
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`ELECTRONIC
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`Please find below and/or attached an Office communication concerning this application or proceeding.
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`The time period for reply, if any, is set in the attached communication.
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`Notice of the Office communication was sent electronically on above—indicated "Notification Date" to the
`following e—mail address(es):
`PTODOCKET @ ARELAWCOM
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`PTOL—90A (Rev. 04/07)
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`

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`Office Action Summary
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`Application No.
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`Applicant(s)
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` 13/609,305 MIYAZAKI ET AL.
`Examiner
`Art Unit
`MARIS R. KESSEL
`1759
`
`-- 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 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 CFR1. 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).
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`Status
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`1)|:I Responsive to communication(s) filed on
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`.
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`2a)|:l This action is FINAL.
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`2b)IXI This action is non-final.
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`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)|:l 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.
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`Disposition of Claims
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`5)IZ Claim(s) His/are pending in the application.
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`5a) Of the above claim(s) _ is/are withdrawn from consideration.
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`6)|:| Claim(s) _ is/are allowed.
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`7)|Xl Claim(s) His/are rejected.
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`8)|:| Claim(s) _ is/are objected to.
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`9)I:I Claim(s)
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`are subject to restriction and/or election requirement.
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`* 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
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`httn:,I/www usntq. quwua'ertslanr events/
`h/Indexis or send an inquiry to PPeredback us Emmi.
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`Application Papers
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`10)I:| The specification is objected to by the Examiner.
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`11)|:I The drawing(s) filed on _ is/are: a)I:I accepted or b)I:I objected to by the Examiner.
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`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
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`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
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`Priority under 35 U.S.C. § 119
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`12)|:| Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
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`a)I:I All
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`b)|:l Some * c)I:I None of:
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`1.I:I Certified copies of the priority documents have been received.
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`2.|:l Certified copies of the priority documents have been received in Application No. _
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`3.I:I 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)).
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`* See the attached detailed Office action for a list of the certified copies not received.
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`
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`Attachment(s)
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`1) IZI Notice of References Cited (PTO-892)
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`2) D Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mai| Date
`US. Patent and Trademark Office
`PTOL-326 (Rev. 09-12)
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`3) I] Interview Summary (PTO-413)
`Paper No(s)/Mai| Date.
`4) D Other:
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`Office Action Summary
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`Part of Paper No./Mai| Date 20130122
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`

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`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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`Claim Rejections - 35 USC § 112
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`1.
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`The following is a quotation of 35 U.S.C. 112(b):
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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.
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`The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph:
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`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.
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`2.
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`Claims 34-37 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA),
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`second paragraph, as being indefinite for failing to particularly point out and distinctly
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`claim the subject matter which the inventor or a joint inventor, or for pre-AIA the
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`applicant regards as the invention.
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`Regarding claim 34, the limitations “detecting a temperature change between a
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`temperature measured before the quantity of the substrate is measured and a
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`temperature measured when the quantity of the substrate is measured” and
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`“determining, according to the temperature change, whether the quantity of the
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`substrate is measured or not” renders the claim unclear and indefinite. Since the second
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`temperature reading is measured when the quantity of the substrate is measured, it
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`is unclear how according to the temperature change, it is determined whether the
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`quantity of the substrate is measured or not. The quantity of the substrate has been
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`measured at the time the second temperature is detected. Claims 35-37 are rejected as
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`dependent thereon. Appropriate correction is required.
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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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`Claim Rejections - 35 USC § 102
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`3.
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`The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that
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`form the basis for the rejections under this section made in this Office action:
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`A person shall be entitled to a patent unless —
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`(b) the invention was patented or described in a printed publication in this or a foreign country or in
`public use or on sale in this country, more than one year prior to the date of application for patent in
`the United States.
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`4.
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`Claims 34-36 are rejected under 35 U.S.C. 102(b) as being anticipated by White
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`et al. (US 5,405,511) (hereinafter "White").
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`Regarding claim 34, White teaches a method of measuring a quantity of a
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`substrate (col. 4, lns. 36-43), comprising: providing a biosensor to which sample liquid
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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); detecting a temperature
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`change between a temperature measured before the quantity of the substrate is
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`measured and a temperature measured when the quantity of the substrate is measured
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`(Fig. 4, col. 4, In. 63- col. 5, ln. 5, col. 5, In. 65 - col. 6, In. 24, Tnew, Told); and
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`determining, according to the temperature change, whether the quantity of the substrate
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`is measured or not (using Tambiem operating limits to perform temperature correction for
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`glucose measurements, col. 7, lns. 26-30).
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`Regarding claim 35, White teaches further comprising stopping measurement of
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`the substrate when the temperature change exceeds a predetermined threshold (If
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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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`Tambiem is not within proper operating limits then the test is aborted, Tambiem is based on
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`difference between Tnew and Told, col. 7, lns. 14-25).
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`Regarding claim 36, White teaches wherein the step of detecting the temperature
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`change comprises intermittently detecting the temperature measured before the
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`quantity of the substrate is measured (Fig. 4).
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`Claim Rejections - 35 USC § 103
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`5.
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`The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all
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`obviousness rejections set forth in this Office action:
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`(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.
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`6.
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`This application currently names joint inventors.
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`In considering patentability of
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`the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of
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`the various claims was commonly owned at the time any inventions covered therein
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`were made absent any evidence to the contrary. Applicant is advised of the obligation
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`under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was
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`not commonly owned at the time a later invention was made in order for the examiner to
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`consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g)
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`prior art under 35 U.S.C. 103(a).
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`7.
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`Claim 37 is rejected under 35 U.S.C. 103(a) as being unpatentable over White as
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`applied to claim 34 above, and further in view of Demmin et al. (US 5,554,273)
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`(hereinafter "Demmin").
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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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`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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`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. It would
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`have been obvious to one of ordinary skill in the art at the time the invention was made
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`to substitute the single sensor as taught by White with the multiple sensors as taught by
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`Demmin because doing so would increase the accuracy of temperature readings and
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`compensate for the thermal gradient.
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`Conclusion
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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
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`(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.
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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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`/M. R. K./
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`M.R.K.
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`Examiner, Art Unit 1759
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`/LUAN V VAN/
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`Supervisory Patent Examiner, Art Unit 1759
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`