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
`
`15/643,432
`
`07/06/2017
`
`Hirofumi EZAKI
`
`PHC-US100931-A
`
`3953
`
`10/09/2018
`
`7590
`91218
`Shinjyu Global IP
`1-4-19 Minamimori-maehi, Kita-ku
`South Forest Building, 11th Floor
`Osaka, 530-0054
`JAPAN
`
`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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`10/09/2018
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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
`1726
`
`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 08/01/2018.
`[:1 A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
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`2a). This action is FINAL.
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`2b) C] 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
`
`8
`
`
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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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`2) E] Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`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 20181002
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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 ACTION
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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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`1.
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`2.
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`This is the response to the communication filed on 08/01/2018.
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`Claims 1-8 remain pending in the application.
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`1.
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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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`2.
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`Claim(s) 1-5 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 first side wall, a second side wall opposite to the first side wall
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`(fig. 2a-2e) and a back wall perpendicular to the first and second side walls;
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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 inside the cavity;
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`a counter electrode 4 inside the cavity;
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`a detecting electrode (the combination of elements 8a, 5a, 2 and 3 constitute the
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`claimed detecting electrode) inside the cavity and extending from the back wall toward the
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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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`suction opening and being spaced apart from the first and second side walls of the cavity (figs. 1
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`and 2a-2e, fig. 1 shows the portions 2 and 5a of the detecting electrode extending from the back
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`wall toward the suction opening 14 and being spaced apart from the first and second side walls
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`of the cavity);
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`a diverter including a convex portion (please see annotated fig. 2a below) being a
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`portion of both the first and second side walls; and wherein
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`the sensor is configured to have the biological sample advance along a path from the
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`suction opening 14 to the detecting electrode,
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`the back wall has a planar shape,
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`the first and second side walls are positioned such that the diverter is configured to
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`extend along the path from 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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`

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`Application/Control Number: 15/643,432
`Art Unit: 1726
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`Page 4
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`Addressing claim 2, Carter further discloses:
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`a substrate 1;
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`a spacer 7 on the substrate; and
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`a cover 13 on the spacer;
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`wherein the cavity further includes:
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`a bottom including the substrate, and
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`a ceiling including the cover;
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`wherein the first and second side walls include the spacer (figs. 1-1a),
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`wherein the working electrode, the counter electrode, and the detecting electrode are
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`on the substrate, and
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`wherein the detecting electrode is disposed at a position in the cavity at a position
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`furthest from the suction opening (in figs. 2c-2d, the detecting electrode 8a is at a position in
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`the cavity that is furthest from the suction opening relative to the working electrode 8, the claim
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`does not specify the relative word ”furthest” in reference to what other elements of the sensor;
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`alternatively, fig. 2 discloses all 3 electrodes are at the same position, which means they are
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`equally position at the furthest position from the suction opening; alternatively, in fig. 2e, the
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`electrode 4 is the structural equivalence to the claimed detecting electrode and the electrode 8a
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`is the structural equivalence to the claimed counter electrode because the words ”detecting”
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`and ”counter” are drawn to the intended use of the electrodes that do not structurally
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`differentiate the claimed electrodes from that of Carter’s; therefore, the electrode 4 is
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`positioned at a position furthest from the suction opening in fig. 2e).
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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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`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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`Addressing claim 4, Carter discloses the electrode strip is used in an electrochemical sensor (col.
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`1|n 66-67), which is the equivalence to the claimed a measurement device.
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`Addressing claim 5, fig. 1 shows the portion 5a of the detecting electrode is tapered at one end
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`thereof.
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`Claim Rejections - 35 USC § 103
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`3.
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`The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness
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`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, 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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`4.
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`The factual inquiries set forth in Graham v. John Deere C0,, 383 U.S. 1, 148 USPQ 459 (1966),
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`that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C.
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`103(a) are summarized as follows:
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`1. Determining the scope and contents of the prior art.
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`2. Ascertaining the differences between the prior art and the claims at issue.
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`3. Resolving the level of ordinary skill in the pertinent art.
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`4. Considering objective evidence present in the application indicating obviousness or
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`nonobviousness.
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`

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`Application/Control Number: 15/643,432
`Art Unit: 1726
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`Page 6
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`5.
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`Claim 6 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Carter et al.
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`(US 5,628,890).
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`Addressing claim 6, Carter is silent regarding the claimed shape of the detecting electrode.
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`However, lacking disclosure regarding the significance of the claimed shape of the detecting
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`electrode, the claimed shape is obvious to one of ordinary skill in the art (MPEP 2144.04, section
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`IV. 3.).
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`6.
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`Claims 7-8 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Carter et
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`al. (US 5,628,890) in view of Sato (US 2004/0216516).
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`Addressing claims 7-8, Carter discloses the cavity is defined only in the spacer while the suction
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`opening is defined only in the cover (fig. 1).
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`Carter is silent regarding the cavity and the suction opening is defined only in the spacer.
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`Sato discloses an electrochemical test strip similarly to that of Carter; wherein, in one
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`embodiment (fig. 9), the suction opening 593 is defined only in the cover and the cavity is
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`defined only in the spacer similarly to that of Carter.
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`In a different embodiment (fig. 10), Sato
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`discloses that both the cavity and the suction opening are defined only in the spacer.
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`At the time of the effective filing date of the invention, one with ordinary skill in the art would
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`have found it obvious to modify the known suction opening and cavity configuration of Carter
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`with the known configuration in which both the cavity and the suction opening are defined only
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`by the spacer as disclosed by Sato in order to obtain the predictable result of drawing the
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`biological sample into the cavity for contacting electrode in electrochemical detection. Figs. 9-
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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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`10 of Sato clearly show that either configuration would provide the predictable result of drawing
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`the biological sample into the cavity for contacting electrode in electrochemical detection. The
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`configuration in fig. 10 of Sato includes the openings in the cover layer for enhancing the
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`movement of the biological sample within the cavity (fig. 10, [0052]).
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`Response to Arguments
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`7.
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`Applicant’s arguments, see the Remarks, filed 08/01/2018, with respect to the 35 USC 102(b)
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`rejections of claims 1-4 as being anticipated by Nankai have been fully considered and are persuasive.
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`The 35 USC 102(b) rejection of claims 1-4 based on Nankai has been withdrawn.
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`8.
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`Applicant's arguments filed 08/01/2018 regarding the 35 USC 102(b) rejections of claims 1-4 as
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`being anticipated by Carter have been fully considered but they are not persuasive for the following
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`reasons:
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`a.
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`The Applicants argued that Carter does not disclose that the detecting electrode
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`extending from the back wall toward the suction opening and being spaced apart from the first
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`and second side walls of the cavity. The argument is not persuasive because in figs. 1 and 2a-2e,
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`Carter discloses the detecting electrode, which includes elements 8a, 5a, 2 and 3, extending
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`from the back wall toward the suction opening and being spaced apart from the first and second
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`side walls of the cavity.
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`b.
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`For the reasons above, Examiner maintains the position that claims 1-5 are anticipated
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`by Carter.
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`

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`Application/Control Number: 15/643,432
`Art Unit: 1726
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`Page 8
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`Conclusion
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`9.
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`Applicant's amendment necessitated the new ground(s) of rejection presented in this Office
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`action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the
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`extension of time policy as set forth in 37 CFR 1.136(a).
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`A shortened statutory period for reply to this final action is set to expire THREE MONTHS from
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`the mailing date of this action.
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`In the event a first reply is filed within TWO MONTHS of the mailing date
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`of this final action and the advisory action is not mailed until after the end of the THREE-MONTH
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`shortened statutory period, then the shortened statutory period will expire on the date the advisory
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`action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing
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`date of the advisory action.
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`In no event, however, will the statutory period for reply expire later than
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`SIX MONTHS from the date of this final action.
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`10.
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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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`normally be reached on Mon-Friday 8:00 - 4:30 EST.
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`Examiner interviews are available via telephone, in-person, and video conferencing using a
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`USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use
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`the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor,
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`Keith Hendricks can be reached on (571)-272-1401. The fax phone number for the organization where
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`this application or proceeding is assigned is 571-273-8300.
`
`Information regarding the status of an application may be obtained from the Patent Application
`
`Information Retrieval (PAIR) system. Status information for published applications may be obtained
`
`from either Private PAIR or Public PAIR. Status information for unpublished applications is available
`
`through Private PAIR only. For more information about the PAIR system, see http://pair-
`
`