UNITED STATES PATENT AND TRADEMARK OFFICE
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`
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`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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`15/323,001
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`12/29/2016
`
`Masayuki SAIKI
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`096534-0014
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`3657
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`MCDERMOTT WILL & EMERY LLP
`
`THE MCDERMOTT BUILDING
`500 NORTH CAPITAL STREET, NW.
`WASHINGTON, DC 20001
`
`NAGPAUL JYOTI
`
`1798
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`PAPER NUMBER
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`NOTIFICATION DATE
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`DELIVERY MODE
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`06/03/2019
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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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`ipdoeketmwe @ mwe. com
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`PTOL-90A (Rev. 04/07)
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`

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`0/7709 A0170” Summary
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`Application No.
`15/323,001
`Examiner
`JYOTI NAGPAU L
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`Applicant(s)
`SAIKI et al.
`Art Unit
`1798
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`AIA (FITF) Status
`Yes
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`- The MAILING DA TE of this communication appears on the cover sheet wit/7 the correspondence address -
`Period for Reply
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`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
`[: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)C] 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*
`5) E] Claim(s)
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`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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`[3 Claim(s)
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`is/are allowed.
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`Claim(s) 1—13 and 15—21 is/are rejected.
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`C] Claim(s) _
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`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
`[: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
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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.'sp 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)C] accepted or b)E] 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).
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`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)I:] All
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`b)C] Some**
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`c)C] None of the:
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`1C] Certified copies of the priority documents have been received.
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`2C] Certified copies of the priority documents have been received in Application No.
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`31:] 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
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`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 20190528
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`

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`Application/Control Number: 15/323,001
`Art Unit: 1798
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`Page 2
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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.
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`In the event the determination of the status of the application as subject to AIA 35
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`U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any
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`correction of the statutory basis for the rejection will not be considered a new ground of
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`rejection if the prior art relied upon, and the rationale supporting the rejection, would be
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`the same under either status.
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`This application currently names joint inventors. In considering patentability of the
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`claims the examiner presumes that the subject matter of the various claims was
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`commonly owned as of the effective filing date of the claimed invention(s) absent any
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`evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to
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`point out the inventor and effective filing dates of each claim that was not commonly
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`owned as of the effective filing date of the later invention in order for the examiner to
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`consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2)
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`prior art against the later invention.
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`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:
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`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. Patentabiiity shall not be
`negated by the manner in which the invention was made.
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`

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`Application/Control Number: 15/323,001
`Art Unit: 1798
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`Page 3
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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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`Claims 1-13 and 15-21 is/are rejected under 35 U.S.C. 103 as being
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`unpatentable over Burtis (US 5173262) in view of Saiki (US 2010/0255589).
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`Regarding claim 1, Burtis teaches a substrate for sample analysis used for
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`causing a binding reaction between an analyte and a ligand in a liquid sample, the
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`substrate for sample analysis comprising a base substrate (228) having a rotation axis
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`and a predetermined thickness; a chamber (270) located in the base substrate and
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`configured to hold a liquid sample containing an analyte and a ligand immobilized on a
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`surface of magnetic particles; at least one magnet (226) arranged at a position where
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`the magnetic particles are captured in the chamber by the magnet.
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`Burtis fails to teach a balancer arranged at a position where, when the at least
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`one magnet is attached, a center of gravity of the substrate generally coincide with the
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`rotation axis.
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`Saiki teaches an analyzing device comprising a balancer (142) for ensuring
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`balance during rotation.
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`

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`Application/Control Number: 15/323,001
`Art Unit: 1798
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`Page 4
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`It would have been obvious to one having ordinary skill in the art to provide the
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`device of Burtis with a balancer arranged at a position where, when the at least one
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`magnet is attached for ensuring balance during rotation.
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`Regarding claim 2, the at least one magnet (226) is provided at a position in the
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`vicinity of a bottom surface of the chamber.
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`Regarding claim 3, the at least one magnet (226) is provided at a position in the
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`vicinity of a wall surface of the chamber of the base substrate; and the wall surface is a
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`surface whose normal extends in a direction in which a centrifugal force due to rotation
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`is exerted.
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`(Refer to Figure 25-27)
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`Regarding claim 4, the at least one magnet (226) is provided at a position in the
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`vicinity of a wall surface of the chamber of the base substrate; and the wall surface is a
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`surface on one side where the liquid sample is supported against a centrifugal force due
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`to rotation.
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`(Refer to Figure 25-27)
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`Regarding claim 5, the at least one magnet (226) is detachably attached to the
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`base substrate.
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`Regarding claim 6, the base substrate (228) includes an upper surface and a
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`lower surface; and the at least one magnet (226) is attached at the upper surface so as
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`to be detachable off the upper surface.
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`(Refer to Figures 25-27)
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`Regarding claim 7, the base substrate (228) includes an accommodating
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`chamber in the upper surface for accommodating the at least one magnet.
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`(Refer to
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`Figure 25)
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`

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`Application/Control Number: 15/323,001
`Art Unit: 1798
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`Page 5
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`Regarding claim 8, with the at least one magnet (226) attached to the base
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`substrate, the at least one magnet is projecting from the upper surface.
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`(Refer to Figure
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`26)
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`Regarding claim 9, the at least one magnet (226) is provided in a magnet unit;
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`and the at least one magnet (226) is attached/detached to/from the base substrate as
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`the magnet unit is attached/detached to/from the base substrate.
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`Regarding claim 10, the magnet unit (226) is attached at the lower surface so as
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`to be detachable off the lower surface.
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`(Refer to Figure 26)
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`Regarding claim 11, wherein with the magnet unit (226) attached to the base
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`substrate, the at least one magnet is arranged at a position in the vicinity of the
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`chamber.
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`(Refer to Figure 25-26)
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`Regarding claim 12, the base substrate (228) includes an accommodating
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`chamber for accommodating the at least one magnet (226) when the magnet unit is
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`attached to the base substrate.
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`Regarding claim 13, the at least one magnet (226) is a plurality of magnets.
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`Regarding claims 15-17, Burtis fails to teach the balancer is a non-magnet.
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`It would have been obvious to one having ordinary skill in the art to provide the
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`balancer of is a non-magnet of Saiki to ensure the balance of rotation.
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`Regarding claim 18, Burtis teaches the sample analysis device comprising a
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`motor (62) that rotates the substrate for sample analysis; a driver circuit (258) that
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`drives the motor; and a detection mechanism (261) that drives detects whether or not
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`the at least one magnet is attached by using at least one of a weight of the substrate for
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`sample analysis, a magnetic characteristic thereof, an optical characteristic thereof, a
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`

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`Application/Control Number: 15/323,001
`Art Unit: 1798
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`Page 6
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`current value or a voltage value in accordance with a rotational load thereof, a rotational
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`acceleration thereof and a steady rotation speed thereof.
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`Regarding claim 19, a signal generation circuit (261) that generates a signal
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`notifying of a detection result when the detection mechanism detects that the at least
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`one magnet is not attached.
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`Regarding claim 20, the signal generation circuit (261) generates a signal for
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`outputting a sound, light or an image.
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`Regarding claim 21, a rotation axis has an angle of 0° or more and 90° or less
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`with respect to a direction of gravity.
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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 JYOTI NAGPAUL whose telephone number is (571 )272-
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`1273. The examiner can normally be reached on M-F 9am to 5pm, EST.
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`Examiner interviews are available via telephone, in-person, and video
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`conferencing using a USPTO supplied web-based collaboration tool. To schedule an
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`interview, applicant is encouraged to use the USPTO Automated Interview Request
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`(AIR) at http://www.uspto.gov/interviewpractice.
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
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`supervisor, Jill Warden can be reached on 571-272-1267. 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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`Information regarding the status of an application may be obtained from the
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`Patent Application Information Retrieval (PAIR) system. Status information for
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`

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`Application/Control Number: 15/323,001
`Art Unit: 1798
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`Page 7
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`published applications may be obtained from either Private PAIR or Public PAIR.
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`Status information for unpublished applications is available through Private PAIR only.
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`For more information about the PAIR system, see http://pair-direct.uspto.gov. Should
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`you have questions on access to the Private PAIR system, contact the Electronic
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`Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a
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`USPTO Customer Service Representative or access to the automated information
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`system, call 800-786-9199 (IN USA OR CANADA) or 571 -272-1 000.
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`/JYOTI NAGPAUL/
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`Primary Examiner, Art Unit 1798
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`