UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria, Virginia 2231371450
`www.uspto.gov
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`15/643,432
`
`07/06/2017
`
`Hirofumi EZAKI
`
`PHC-US100931-A
`
`3953
`
`05/01/2018
`
`7590
`91218
`Shinjyu Global IP
`1-4-19 Minamimori-maehi, Kita-ku
`South Forest Building, 11th Floor
`Osaka, 530-0054
`JAPAN
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`EXAMINER
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`DLNH, BACH T
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`PAPER NUMBER
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`ART UNIT
`1726
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`NOTIFICATION DATE
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`DELIVERY MODE
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`05/01/2018
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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
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`following e—mail address(es):
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`shinjyuefiling @ gmail.eom
`teammurai @ giplaw-osaka.eo.jp
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`PTOL-90A (Rev. 04/07)
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`

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`Off/09 A0170” Summary
`
`Application No.
`15/643,432
`Examiner
`BACH T DINH
`
`Applicant(s)
`EZAKI et al.
`Art Unit
`1756
`
`AIA Status
`No
`
`- The MAILING DA TE of this communication appears on the cover sheet wit/7 the correspondence address -
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE g MONTHS 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 (6) MONTHS from the mailing date of this communication.
`|f 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). Responsive to communication(s) filed on 07/06/2017.
`[:1 A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
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`2a)D This action is FINAL.
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`2b)
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`This action is non-final.
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`3)[:] 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.
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`4)[:] 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 Expat/7e Quay/e, 1935 CD. 11, 453 O.G. 213.
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`Disposition of Claims*
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`5)
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`Claim(s) fl is/are pending in the application.
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`5a) Of the above claim(s)
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`is/are withdrawn from consideration.
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`E] Claim(s)
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`is/are allowed.
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`Claim(s) fl is/are rejected.
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`[:1 Claim(s) _ is/are objected to.
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`) ) ) )
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`6 7
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`8
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`
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`are subject to restriction and/or election requirement
`[j Claim(s)
`9
`* If any claims have been determined aflowabte. you may be eligible to benefit from the Patent Prosecution Highway program at a
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`participating intellectual property office for the corresponding application. For more information, please see
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`http://www.uspto.gov/patents/init events/pph/index.jsp or send an inquiry to PPeredback@uspto.gov.
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`Application Papers
`10)[:] The specification is objected to by the Examiner.
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`11)[:] The drawing(s) filed on
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`is/are: a)D accepted or b)l:] 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).
`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):] Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
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`a)D All
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`b)I:J Some”
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`c)C] None of the:
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`1.[:]
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`Certified copies of the priority documents have been received.
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`2.[:]
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`Certified copies of the priority documents have been received in Application No.
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`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)).
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`** See the attached detailed Office action for a list of the certified copies not received.
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`Attachment(s)
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`1)
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`Notice of References Cited (PTO-892)
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`Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`2)
`Paper No(s)/Mail Date_
`U.S. Patent and Trademark Office
`
`3) C] Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`4) CI Other-
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`PTOL-326 (Rev. 11-13)
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`Office Action Summary
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`Part of Paper No./Mai| Date 20180426
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`

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`Application/Control Number: 15/643,432
`Art Unit: 1726
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`Page 2
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`DETAILED CORRESPONDENCE
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`Notice of Pre-AIA or AIA Status
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`1.
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`The present application is being examined under the pre-AIA first to invent provisions.
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`Summary
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`2.
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`3.
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`This is the initial Office Action based on the 15/643432 application filed on 07/06/2017.
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`Claims 1-4 are currently pending and have been fully considered.
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`4.
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`The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form
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`Claim Rejections - 35 USC § 102
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`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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`5.
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`Claim(s) 1-4 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Nankai et al.
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`(US 5,120,420).
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`Addressing claim 1, Nankai discloses a sensor (fig. 12) comprising:
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`a cavity 8 including a side wall and a back wall;
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`a suction opening 10 from an outside of the sensor to an inside of the cavity;
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`a working electrode 42 disposed inside the cavity;
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`a counter electrode 5 disposed inside the cavity;
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`a detecting electrode 41 disposed inside the cavity toward the suction opening from the
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`back wall and spaced apart from the side wall of the cavity (fig. 12);
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`

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`Application/Control Number: 15/643,432
`Art Unit: 1726
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`Page 3
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`a diverter including a convex portion (please see annotated fig. 12 below) being a
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`portion of the side wall; and wherein
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`the biological sample advances along a path from the suction opening 10 to the
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`detecting electrode 4,
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`the back wall has a planar shape (fig. 12),
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`the side wall is disposed so that the diverter is configured to extend along the path from
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`the suction opening to the detecting electrode 41, and
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`a width (A) of the cavity is smaller than a width (B) of the path on the side of the back
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`wall.
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`
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`Addressing claim 2, Nankai further discloses:
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`a substrate 1;
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`a spacer 7 disposed on the substrate; and
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`a cover 9 disposed on the spacer;
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`the cavity further including:
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`a bottom of the cavity including the substrate, and
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`

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`Application/Control Number: 15/643,432
`Art Unit: 1726
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`Page 4
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`a ceiling of the cavity including the cover; and
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`wherein the side wall includes the spacer,
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`the working electrode 42, the counter electrode 5, and the detecting electrode 41 are
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`formed on the substrate, and
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`the detecting electrode 41 is disposed at a position in the cavity furthest from the
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`suction opening 10.
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`Addressing claim 3, the convex portion in fig. 12 is formed with the spacer, which is formed on
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`the bottom of the cavity; therefore, the convex portion is formed on the bottom of the cavity as
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`claimed.
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`Addressing claim 4, Nankai disclose the biosensor is a disposable biosensor and fig. 7 shows the
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`correlation between the glucose concentration and the response current; therefore, the device
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`that interfaces with the biosensor for measuring the concentration of glucose from the resulting
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`current is the claimed measurement device.
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`6.
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`Claim(s) 1-4 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Carter et al.
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`(US 5,628,890).
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`Addressing claim 1, Carter discloses a sensor comprising:
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`a cavity 12 including a side wall and a back wall;
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`a suction opening 14 from an outside of the sensor to an inside of the cavity;
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`a working electrode 8 disposed inside the cavity;
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`a counter electrode 4 disposed inside the cavity;
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`

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`Application/Control Number: 15/643,432
`Art Unit: 1726
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`Page 5
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`a detecting electrode 8a disposed inside the cavity toward the suction opening from the
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`back wall and spaced apart from the side wall of the cavity (figs . 2-2e);
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`a diverter including a convex portion (please see annotated fig. 2a below) being a
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`portion of the side wall; and wherein
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`the biological sample advances along a path from the suction opening 14 to the
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`detecting electrode,
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`the back wall has a planar shape,
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`the side wall is disposed so that the diverter is configured to extend along the path from
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`the suction opening to the detecting electrode, and
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`a width (A) of the cavity is smaller than a width (B) of the path on a side of the back wall.
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`
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`Addressing claim 2, Carter further discloses:
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`

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`Application/Control Number: 15/643,432
`Art Unit: 1726
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`a substrate 1;
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`Page 6
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`a spacer 7 disposed on the substrate; and
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`a cover 13 disposed on the spacer;
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`the cavity further including:
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`a bottom of the cavity including the substrate, and
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`a ceiling of the cavity including the cover; and
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`wherein the side wall includes the spacer (figs. 1-1a),
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`the working electrode, the counter electrode, and the detecting electrode are formed
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`on the substrate, and
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`the detecting electrode is disposed at a position in the cavity at a position furthest from
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`the suction opening (in figs. 2c-2d, the detecting electrode 8a is at a position in the cavity that is
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`furthest from the suction opening relative to the working electrode 8, the claim does not specify
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`the relative word ”furthest” in reference to what other elements of the sensor; alternatively,
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`fig. 2 discloses all 3 electrodes are at the same position, which means they are equally position
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`at the furthest position from the suction opening; alternatively, in fig. 2e, the electrode 4 is the
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`structural equivalence to the claimed detecting electrode and the electrode 8a is the structural
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`equivalence to the claimed counter electrode because the words ”detecting” and ”counter” are
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`drawn to the intended use of the electrodes that do not structurally differentiate the claimed
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`electrodes from that of Carter’s; therefore, the electrode 4 is positioned at a position furthest
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`from the suction opening in fig. 2e).
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`Addressing claim 3, the convex portion is formed as part of the spacer 7 that is formed on the
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`bottom of the cavity; therefore, the convex portion is formed on the bottom of the cavity.
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`

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`Application/Control Number: 15/643,432
`Art Unit: 1726
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`Page 7
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`Addressing claim 4, Carter discloses the electrode strip is sued in an electrochemical sensor (col.
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`1 In 66-67), which is the equivalence to the claimed a measurement device.
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`Conclusion
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`7.
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`Any inquiry concerning this communication or earlier communications from the examiner
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`should be directed to BACH T DINH whose telephone number is (571)270-5118. The examiner can
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor,
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`Jeffrey Barton can be reached on (571)-272-1307. The fax phone number for the organization where
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