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
`
`15/920,135
`
`03/13/2018
`
`Mie TAKAHASHI
`
`065933-0738
`
`8567
`
`MCDERMOTT WILL & EMERY LLP
`
`THE MCDERMOTT BUILDING
`500 NORTH CAPITAL STREET, NW.
`WASHINGTON, DC 20001
`
`BROWN MELANIE W
`
`1641
`
`PAPER NUMBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`07/31/2019
`
`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
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`following e—mail address(es):
`
`ipdoeketmwe @ mwe. com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`0/7709 A0170” Summary
`
`Application No.
`15/920,135
`Examiner
`MELANIE BROWN
`
`Applicant(s)
`TAKAHASHI, Mie
`Art Unit
`AIA (FITF) Status
`1641
`Yes
`
`- 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).
`
`Status
`
`1). Responsive to communication(s) filed on 16 May 2019.
`[: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.
`
`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.
`
`Disposition of Claims*
`5)
`Claim(s)
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`1—15 is/are pending in the application.
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`5a) Of the above claim(s) 3—12 and 15 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) 1—2 and 13—14 is/are rejected.
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`C] Claim(s) _
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`is/are objected to.
`
`) ) ) )
`
`6 7
`
`8
`
`
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`are subject to restriction and/or election requirement
`[:1 Claim(s)
`9
`* 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
`
`http://www.uspto.gov/patents/init events/pph/index.'sp or send an inquiry to PPeredback@uspto.gov.
`
`Application Papers
`10):] The specification is objected to by the Examiner.
`
`11). The drawing(s) filed on 13 March 2018 is/are: a). accepted or b)l:] 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). Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`
`a). All
`
`b)|:] Some**
`
`c)C] None of the:
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`1.. Certified copies of the priority documents have been received.
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`2.|:] Certified copies of the priority documents have been received in Application No.
`
`3D Copies of the certified copies of the priority documents have been received in this National Stage
`application from the International Bureau (PCT Rule 17.2(a)).
`
`** See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`
`1)
`
`Notice of References Cited (PTO-892)
`
`Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`2)
`Paper No(s)/Mail Date m.
`U.S. Patent and Trademark Office
`
`3) C] Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`4) CI Other-
`
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mai| Date 20190726
`
`

`

`Application/Control Number: 15/920,135
`Art Unit: 1641
`
`Page 2
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`DETAILED ACTION
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`Notice of Pre-AIA or AIA Status
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`The present application, filed on or after March 16, 2013, is being examined
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`under the first inventor to file provisions of the AIA.
`
`Election/Restrictions
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`1.
`
`Applicant’s election without traverse of group I and species group A-i) in the reply
`
`filed on 16 May 2019 is acknowledged. The elected species reads on claims 1, 2, 13
`
`and 14.
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`Claims 3-12 and 15 are withdrawn as being drawn to non-elected inventions.
`
`Claim Rejections - 35 USC § 1 12
`
`The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
`
`(a) IN GENERAL—The specification shall contain a written description of the
`invention, and of the manner and process of making and using it, in such full, clear, concise,
`and exact terms as to enable any person skilled in the art to which it pertains, or with which it
`is most nearly connected, to make and use the same, and shall set forth the best mode
`contemplated by the inventor orjoint inventor of carrying out the invention.
`
`The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
`
`The specification shall contain a written description of the invention, and of the
`manner and process of making and using it, in such full, clear, concise, and exact terms as to
`enable any person skilled in the art to which it pertains, or with which it is most nearly
`connected, to make and use the same, and shall set forth the best mode contemplated by the
`inventor of carrying out his invention.
`
`2.
`
`Claim 2 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first
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`paragraph, as falling to comply with the written description requirement. The claim(s)
`
`contains subject matter which was not described in the specification in such a way as to
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`

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`Application/Control Number: 15/920,135
`Art Unit: 1641
`
`Page 3
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`reasonably convey to one skilled in the relevant art that the inventor or a joint inventor,
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`or for pre-AIA the inventor(s), at the time the application was filed, had possession of
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`the claimed invention.
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`In the specification, applicant has disclosed separate
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`embodiments where the first liquid supply port and first exhaust hole are arranged with
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`the analyte trap interposed therebetween in the first flow channel and the second liquid
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`supply port and the second exhaust hole are arranged with the analyte trap interposed
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`therebetween in the second flow channel (Figures 20-22) and the second liquid supply
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`port also serving as the first exhaust hole (Figures 3 and 4), but does not disclose an
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`embodiment where both conditions are met together. Furthermore, the structural
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`differences between the embodiments would prohibit both the second liquid supply port
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`serving as the first exhaust hole AND the analyte trap to be interposed between a) the
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`first liquid supply port and first exhaust hole and b) the second liquid supply port and
`
`second exhaust hole. Therefore the specification fails to provide adequate written
`
`description for the limitations of claim 2.
`
`Claim Rejections - 35 USC § 102
`
`The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that
`
`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 —
`
`(a)(1) the claimed invention was patented, described in a printed publication, or in public use,
`on sale or otherwise available to the public before the effective filing date of the claimed
`invention.
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`3.
`
`Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by
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`Blankenstein et al. (US 2004/0096358).
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`

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`Application/Control Number: 15/920,135
`Art Unit: 1641
`
`Page 4
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`Blankenstein et al. teach a sensor comprising:
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`a substrate (plastic body substrate, par. 30);
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`a first chamber positioned inside the substrate (channel section, 48, Fig. 1-7, par.
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`30);
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`a first liquid supply port which communicates between the first chamber and an
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`outside of the substrate and through which a first liquid containing an analyte flows from
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`the outside of the substrate to the first chamber (inlet opening, par. 30);
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`an analyte trap positioned inside the first chamber and structured to capture the
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`analyte in the first liquid (third channel section contains an immobilized antibody for
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`binding to an analyte, par. 22);
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`a first exhaust hole which communicates between the first chamber and the
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`outside of the substrate (42, Fig. 1-7; par. 31-36);
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`a first flow channel positioned inside the first chamber and connecting the first
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`liquid supply port, the analyte trap and the first exhaust hole (channel is described as
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`connecting the inlet, reaction chambers and vent holes, par. 30-36);
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`a second liquid supply port which communicates between the first chamber and
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`an outside of the first chamber (the claims are interpreted in light of the instant
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`specification which describes, at par. 34, that the first liquid supply port may also serve
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`as the second liquid supply port, therefore the first liquid supply port taught by
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`Blankenstein is interpreted as the second liquid supply port, par. 31);
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`a second exhaust hole which communicates between the first chamber and the
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`outside of the substrate and is switchable from a closed state to an opened state (outlet
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`

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`Application/Control Number: 15/920,135
`Art Unit: 1641
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`Page 5
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`opening, 18, is closed, Fig. 1-7, par. 33 and opened when fluid flow out of the outlet is
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`desired, par. 35); and
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`a second flow channel positioned inside the first chamber and connecting the
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`second liquid supply port, the analyte trap and the second exhaust hole (channel
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`connects inlet, reaction chambers and outlet, 14, Fig. 1-7; par. 30),
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`wherein the first liquid supply port and the first exhaust hole are arranged with
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`the analyte trap interposed therebetween in the first flow channel (reaction
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`chamber/analyte trap, 48, is positioned between vent hole, 42, and inlet, 14, Fig. 1-7;
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`par. 30-31),
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`the second liquid supply port and the second exhaust hole are arranged with the
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`analyte trap interposed therebetween in the second flow channel (reaction chamber, 48,
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`between inlet, 14, and outlet, 18, Fig. 1-7),
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`the first liquid is drawn into the first flow channel from the first liquid supply port
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`due to a capillary phenomenon (par. 14) along with discharge from the first exhaust hole
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`and reaches the analyte trap in the closed state of the second exhaust hole (exhaust
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`hole, 42, is uncovered while outlet, 18, remains closed and fluid flows into the reaction
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`chamber/analyte trap, 48, Fig. 4, par. 35), and
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`liquid drawn through the second flow channel due to a capillary phenomenon
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`(par. 14) along with discharge from the second exhaust hole, passes through the
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`analyte trap (48, Fig. 1-7) and removes the first liquid from the analyte trap in the
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`second opened state of the second exhaust hole (par. 35).
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`With respect to the first exhaust hole and the second exhaust hole, Blankenstein
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`does not specifically teach the gas inside the first chamber flowing to the outside of the
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`

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`Application/Control Number: 15/920,135
`Art Unit: 1641
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`Page 6
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`substrate in the opened state, such a limitation is drawn to a functional limitation of the
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`outlet, the prior art teaches the same reaction chamber and outlet are taught which
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`would allow any gas in the chamber to naturally flow out of an opened outlet (par. 35).
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`Blankenstein does not specifically teach a second liquid containing a wash
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`solution flow from the outside of the first chamber to the first chamber and drawn into
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`the second flow channel from the second liquid supply port. However, this limitation is
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`drawn to a functional limitation of the claimed sensor since the second liquid is used in
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`the sensor, but is not part of the sensor. The sensor of Blankenstein must only be
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`capable of performing any recited functional limitation. Because Blankenstein teaches
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`the same first/second liquid supply port, one having ordinary skill in the art would
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`recognize that any liquid could be injected from outside the channel to inside the
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`channel via the inlet to and travel along the channel to the reaction chambers including
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`the claimed analyte trap. The second fluid flowing through the analyte trap would
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`necessarily remove the first liquid since Blankenstein discloses that fluid in the channel
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`flows out of the outlet/second exhaust hole (par. 35). Therefore the inlet taught by
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`Blankenstein is considered capable of receiving a second liquid.
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`Claim Rejections - 35 USC § 103
`
`The following is a quotation of 35 U.S.C. 103 which forms the basis for all
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`obviousness rejections set forth in this Office action:
`
`A patent for a claimed invention may not be obtained, notwithstanding that the claimed
`invention is not identically disclosed as set forth in section 102, if the differences between the
`claimed invention and the prior art are such that the claimed invention as a whole would have
`been obvious before the effective filing date of the claimed invention to a person having
`ordinary skill in the art to which the claimed invention pertains. Patentability shall not be
`negated by the manner in which the invention was made.
`
`

`

`Application/Control Number: 15/920,135
`Art Unit: 1641
`
`Page 7
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`The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148
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`USPQ 459 (1966), that are applied for establishing a background for determining
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`obviousness under 35 U.S.C. 103 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
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`obviousness or nonobviousness.
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`4.
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`Claim 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over
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`Blankenstein et al. (US 2004/0096358), as applied to claim 1, in view of Hillman et al.
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`(US 4,756,884).
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`Blankenstein et al. teach a substrate that includes a base substrate with the
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`channel formed within the base substrate (par. 30), but fail to teach the substrate
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`including a base substrate, a spacer member and a cover substrate.
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`Hillman et al. teach a sensor comprising a substrate having a chamber with a
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`flow channel and an analyte trap in a reaction chamber (col. 19, lines 54-56) wherein
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`fluids flow by capillary action in a flow channel using exhaust holes switchable from a
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`closed state to an opened state (col. 19, line 52-col. 20, line 2), wherein the substrate is
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`formed from either a) an injection molded plastic piece (col. 23, lines 4-27), similarly to
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`Blankenstein, or b) from three sheets, an upper sheet (cover substrate), a spacing sheet
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`(spacer member) and a lower sheet (base substrate) (col. 19, lines 40-51), wherein the
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`upper sheet is arranged on a surface of the spacing sheet on a side opposite to the
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`base sheet side (col. 19, lines 40-51), wherein the spacing sheet has a slit extending in
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`

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`Application/Control Number: 15/920,135
`Art Unit: 1641
`
`Page 8
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`a plane direction of the spacer member (capillaries and chambers forms slit extending in
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`the plane of the spacing sheet, Fig. 28), and the first chamber is formed by the surface
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`of the base sheet, the surface of the cover sheet and the slit (Fig. 2B, col. 19, lines 40-
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`col. 20, line 2), in order to provide mechanical stability that withstands capillary action
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`(col. 20, lines 5-9).
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`It would have been obvious to one having ordinary skill before the effective filing
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`date of the claimed invention to substitute for the plastic substrate taught by
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`Blankenstein et al., a three sheet substrate including a base substrate, a spacer
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`member and a cover substrate as taught by Hillman et al. One having ordinary skill in
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`the art would have been motivated to make such a change as a mere alternative and
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`functionally equivalent channel formation in a substrate and since the same expected
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`flow of fluid would have been obtained. The use of alternative and functionally
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`equivalent techniques would have been desirable to those of ordinary skill in the art
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`based on the economics and availability of components.
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`One having ordinary skill in the art would have had a reasonable expectation of
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`success in combining the prior art references because Blankenstein and Hillman are
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`similarly drawn to sensors having a substrate, liquid supply port, analyte trap, exhaust
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`holes that control fluid flow and a channel through which fluids flow by capillary action.
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`5.
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`Claim 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over
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`Blankenstein et al. (US 2004/0096358), as applied to claim 1.
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`Blankenstein et al. teach the sensor further comprising a sealing member
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`structured to close the vent openings and capable of removing the sealing member to
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`

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`Application/Control Number: 15/920,135
`Art Unit: 1641
`
`Page 9
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`open the vent openings (adhesive tape is adhered to cover the vent holes, which would
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`seal them, par. 20), but is silent with respect to a sealing member used to close the
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`outlet/second exhaust hole. However, Blankenstein et al. teach the outlet/second
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`exhaust hole being closed (par. 33) and later opened (par. 35). Therefore it would have
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`been obvious to one having ordinary skill in the art to use the same adhesive tape
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`sealing member used for the vent openings as taught by Blankenstein et al., for the
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`outlet, in order to achieve the same desired function of closing an opening that
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`communicates with outside the channel that is capable of being removed to open the
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`opening.
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`No claims are allowed.
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`Conclusion
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`The prior art made of record and not relied upon is considered pertinent to
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`applicant's disclosure.
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`Glezer et al. (US 2012/0178091) teach a sensor comprising a substrate having a
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`chamber positioned therein and an analyte trap in the first chamber, a first liquid supply
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`port that communicates between the first chamber and an outside of the substrate, a
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`first exhaust hole, a first flow channel positioned in the first chamber that connects the
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`first liquid supply port, the analyte trap and the first exhaust hole, a second exhaust hole
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`communicating between the first chamber and the outside of the substrate and
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`switchable from a closed state to an open state, wherein the first liquid is drawn into the
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`first flow channel from the first liquid supply port under capillary action and reaches the
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`analyte trap in the closed state of the second exhaust hole. Glezer et al. fail to teach a
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`

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`Application/Control Number: 15/920,135
`Art Unit: 1641
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`Page 10
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`second liquid supply port that communicates between the first chamber and an outside
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`of the first chamber and the sensor having the capability of drawing a second liquid into
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`the second flow channel and removing the first liquid when the second exhaust hole is
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`in an opened state.
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`Kido et al. (US 2008/0110500) teach a device comprising a substrate having a
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`first chamber positioned therein, a first liquid supply port, a second liquid supply port, a
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`first exhaust hole, a second exhaust hole that is switchable from a closed state to an
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`opened state and first and second flow channels that partially overlap. Kido et al. fail to
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`teach an analyte trap, the second liquid supply port and the second exhaust hole
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`arranged with the analyte trap interposed therebetween and the device arranged such
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`that the first liquid is drawn into the first flow channel due to capillary action and
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`reaching an analyte trap and the second liquid drawn into the second flow channel due
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`to capillary action to remove the first liquid from the analyte trap into the opened when
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`the second exhaust hole is in an opened state.
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`Verhoeckx et al. (US 2017/0120241) teach a sensor comprising a substrate
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`comprising a chamber, a first liquid supply port, an analyte trap, a first exhaust hole, a
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`first flow channel, a second exhaust hole and the first liquid supply port and the first
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`exhaust hole arranged with the analyte trap interposed therebetween in the first flow
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`channel, wherein the sample is drawn into the first flow channel via capillary action.
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`Verhoeckx et al. fail to teach a second supply port, the second flow channel as claimed
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`and the sensor arranged such that the first liquid is drawn into the first flow channel
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`

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`Application/Control Number: 15/920,135
`Art Unit: 1641
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`Page 11
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`when the second exhaust hole is closed and a second is drawn into the second flow
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`channel when the second exhaust hole is open.
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`Tan et al. (US 2011/0120562) teach a sensor comprising a substrate having a
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`first chamber positioned therein, a first liquid supply port, an analyte trap, a first exhaust
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`hole, a first flow channel, a second liquid supply port that is switchable from a closed
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`state to an opened state, a second exhaust hole and a second flow channel. Tan et al.
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`fail to teach the sensor arranged to supply liquid via capillary action and the second
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`liquid drawn into the analyte trap and removing the first liquid by capillary action when
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`the second exhaust hole is in an opened state.
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`Blankenstein et al. (US 2005/0249641) teach a sensor comprising a substrate, a
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`first chamber positioned in the substrate, a first liquid supply port that communicates
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`between the channel and outside the substrate, an analyte trap positioned in the
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`chamber, a first exhaust hole, a first flow channel, a second exhaust hole switchable
`
`from a closed state to an opened state, wherein the first liquid supply port and the first
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`exhaust hole are arranged with the analyte trap interposed therebetween, the first liquid
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`drawn into the first flow channel by capillary phenomenon when the second exhaust
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`hole is in a closed state and the first liquid flowing from the analyte trap in the opened
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`state of the second exhaust hole. Blankenstein et al. fail to teach a second supply port
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`with the analyte trap formed between the second liquid supply port and the analyte trap.
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`

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`Application/Control Number: 15/920,135
`Art Unit: 1641
`
`Page 12
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to MELANIE BROWN whose telephone number is
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`(571)272-2933. The examiner can normally be reached on M-F 6am-3pm.
`
`Examiner interviews are available via telephone, in-person, and video
`
`conferencing using a USPTO supplied web-based collaboration tool. To schedule an
`
`interview, applicant is encouraged to use the USPTO Automated Interview Request
`
`(AIR) at http://www.uspto.gov/interviewpractice.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
`
`supervisor, Bao-Thuy Nguyen can be reached on 571-272—0824. The fax phone
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`number for 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
`
`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.
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`
`

`

`Application/Control Number: 15/920,135
`Art Unit: 1641
`
`/MELAN|E BROWN/
`
`Primary Examiner, Art Unit 1641
`
`Page 13
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`