UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 2231371450
`www.uspto.gov
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`15/941,836
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`03/30/2018
`
`HirOShi SAIKI
`
`20249.0083USD2
`
`7094
`
`52835
`
`759°
`
`12/13/20”
`
`HAMRE, SCHUMANN, MUELLER & LARSON, P.C.
`45 South Seventh Street
`Suite 2700
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`Minneapolis, MN 55402-1683
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`KWAK' DEAN P
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`1798
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`PAPER NUMBER
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`NOTIFICATION DATE
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`DELIVERY MODE
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`12/13/2019
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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):
`PTOMail@hsml.eom
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`PTOL-90A (Rev. 04/07)
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`

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`0/7709 A0170” Summary
`
`Application No.
`15/941,836
`Examiner
`DEAN KWAK
`
`Applicant(s)
`SAIKI, Hiroshi
`Art Unit
`1798
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`AIA (FITF) Status
`No
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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 31 October 2019.
`El 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) D 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 Expade 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)
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`10,21 and 24—25 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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`
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`[:1 Claim(ss)
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`is/are allowed.
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`8)
`Claim(s 10, 21 and 24—25 is/are rejected.
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`D Claim(ss_) is/are objected to.
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`) ) ) )
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`S)
`are subject to restriction and/or election requirement
`[:1 Claim(s
`* If any claims have been determined aflowable. 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
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`10)|:l The specification is objected to by the Examiner.
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`11). The drawing(s) filed on 30 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).
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`Priority under 35 U.S.C. § 119
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`12). Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
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`a). All
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`b)C] Some**
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`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. 14692315.
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`SD 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) C] Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mail Date_
`U.S. Patent and Trademark Office
`
`3) E] 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 20191206
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`

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`Application/Control Number: 15/941,836
`Art Unit: 1798
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`Page 2
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`DETAILED ACTION
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`Notice ofPre-AIA 0r AIA Status
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`The present application is being examined under the pre—AIA first to invent provisions.
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`Drawings
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`The drawings are objected to under 37 CFR l.83(a). The drawings must show every
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`feature of the invention specified in the claims. Therefore, the measurement spot of the
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`microchannel structure must be shown or the feature(s) canceled from the claim(s). No new
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`matter should be entered.
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`Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to
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`the Office action to avoid abandonment of the application. Any amended replacement drawing
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`sheet should include all of the figures appearing on the immediate prior version of the sheet,
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`even if only one figure is being amended. The figure or figure number of an amended drawing
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`should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure
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`must be removed from the replacement sheet, and where necessary, the remaining figures must
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`be renumbered and appropriate changes made to the brief description of the several views of the
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`drawings for consistency. Additional replacement sheets may be necessary to show the
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`renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an
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`application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet”
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`pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will
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`be notified and informed of any required corrective action in the next Office action. The
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`objection to the drawings will not be held in abeyance.
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`

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`Application/Control Number: 15/941,836
`Art Unit: 1798
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`Page 3
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`Claim Interpretation
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`Regarding claims 10, 21 & 25, the “connecting passage” is being interpreted as the
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`“siphon—shaped connecting passage” of claim 10/L12.
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`Claim Rejections - 35 US C § 112
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`The following is a quotation of 35 USC. 112(b):
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`(b) CONCLUSION.7The specification shall conclude with one or more claims particularly pointing
`out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the
`invention.
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`The following is a quotation of 35 USC. 112 (pre—AIA), second paragraph:
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`The specification shall conclude with one or more claims particularly pointing out and distinctly
`claiming the subject matter which the applicant regards as his invention.
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`Claims 10, 21, 24 & 25 are rejected under 35 USC. 112(b) or 35 USC. 112 (pre—AIA),
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`second paragraph, as being indefinite for failing to particularly point out and distinctly claim the
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`subject matter which the inventor or a joint inventor, or for pre—AIA the applicant regards as the
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`invention.
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`Claim 10 recites the limitation "the connecting passage" in L16. There is insufficient
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`antecedent basis for this limitation in the claim.
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`Claim 21 recites the limitation "the connecting passage" in L1. There is insufficient
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`antecedent basis for this limitation in the claim.
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`Claim 25 recites the limitation "the connecting passage" in L2. There is insufficient
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`antecedent basis for this limitation in the claim.
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`Claim 10 is rejected under 35 USC. 112(b) or 35 USC. 112 (pre—AIA), second
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`paragraph, as being incomplete for omitting essential structural cooperative relationships of
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`elements, such omission amounting to a gap between the necessary structural connections. See
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`

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`Application/Control Number: 15/941,836
`Art Unit: 1798
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`Page 4
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`MPEP § 2172.01. The omitted structural cooperative relationships are: how the microchannel
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`structure is connected to the measurement spot.
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`Claim Rejections - 35 US C § 102
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`In the event the determination of the status of the application as subject to AIA 35 U.S.C.
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`102 and 103 (or as subject to pre—AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the
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`statutory basis for the rejection will not be considered a new ground of rejection if the prior art
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`relied upon, and the rationale supporting the rejection, would be the same under either status.
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`The text of those sections of Title 35, US. Code not included in this action can be found
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`in a prior Office action.
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`Claim(s) 10, 21, 24 & 25 is/are rejected under pre-AIA 35 U.S.C. 102b as being
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`anticipated by Nagaoka et al. (US 2006/0153735).
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`Regarding claim 10, Nagaoka et al. teach a rotary analyzing device (Abstract)
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`comprising:
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`0
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`a microchannel structure (see Figs. 6 & 8 for example), the microchannel
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`structure of the rotary analyzing device comprising:
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`0
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`a separating cavity (212) capable of separating the sample liquid into a solution
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`component and a solid component by using the centrifugal force;
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`0
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`a siphon—shaped connecting passage (218) having a first end connected to an
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`outermost position of the separating cavity along the radial direction of the rotary
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`analyzing device (see annotation in Fig. 8);
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`0
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`an overflow cavity (320) connected to a second end of the connecting passage
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`(see annotation in Fig. 8), the second end being located at a further outside
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`

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`Application/Control Number: 15/941,836
`Art Unit: 1798
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`Page 5
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`position than the outermost position of the separating cavity (see Fig. 8 for
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`example);
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`0
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`a liquid retaining connecting passage (221) connected directly to the second end
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`of the connecting passage to which the overflow cavity is connected and
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`extending toward an inner periphery of the rotary analyzing device (see Fig. 8 for
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`example);
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`0
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`an opened—to—atmosphere cavity (220) connected to an outlet of the liquid
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`retaining connecting passage (see Fig. 8); and
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`0
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`an air hole (222) disposed in the opened—to—atmosphere cavity (see Figs. 6 & 8 for
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`example), allowing fluid communication between the liquid retaining connecting
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`passage and outside atmosphere through the opened—to—atmosphere cavity (see
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`i.e., “These vessels are connected to the atmosphere by perforating the cover
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`above these vent holes” 11 0050).
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`

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`Application/Control Number: 15/941,836
`Art Unit: 1798
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`Page 6
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`Patent Application Publication Jul. 13. 2006 Sheet 8 of 18
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`US 2006/0153735 A1
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`FIG. 8
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`220
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`621
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`401
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`222
`223
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`tst end
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`inner end
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`250
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`261 263
`:25? .
`252
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`402
`253
`242
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`240 /
`243
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`2nd end
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`outer end
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`41
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`232
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`Regarding claims 10 & 21, the limitations “a separating cavity configured to separate the
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`sample liquid into a solution component and a solid component by using the centrifugal force” &
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`“the connecting passage is configured to transfer the solid component to the overflow cavity” do
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`not further define structural configurations the device. It is noted that reciting a structure without
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`identifying any structural differences between the structure in the claims and the structure
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`disclosed in prior art does not further limit in an apparatus claim. Further, reciting "configured
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`to" without identifying any structural differences between the structure in the claims and the
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`structure disclosed in prior art does not further limit in an apparatus claim.
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`

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`Application/Control Number: 15/941,836
`Art Unit: 1798
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`Page 7
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`With regard to limitations in claim 10 (eg, “for transferring a sample liquid to a
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`measurement spot by a centrifugal force caused by rotation of the rotary analyzing device”),
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`these claim limitations are considered process or intended use limitations, which do not further
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`delineate the structure of the claimed apparatus from that of the prior art. Since these claims are
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`drawn to an apparatus statutory class of invention, it is the structural limitations of the apparatus,
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`as recited in the claims, which are considered in determining the patentability of the apparatus
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`itself. These recited process or intended use limitations are accorded no patentable weight to an
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`apparatus. Process limitations do not add patentability to a structure, which is not distinguished
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`from the prior art. A recitation of the intended use of the claimed invention must result in a
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`structural difference between the claimed invention and the prior art in order to patentably
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`distinguish the claimed invention from the prior art. If the prior art structure is capable of
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`performing the intended use, then it meets the claim. See In re Casey, 152 USPQ 235 (CCPA
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`1967); and In re Otto, 136 USPQ 458, 459 (CCPA 1963). The Courts have held that it is well
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`settled that the recitation of a new intended use, for an old product, does not make a claim to that
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`old product patentable. See In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed.
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`Cir. 1997). The Courts have held that the manner of operating an apparatus does not differentiate
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`an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural
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`limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987) (see MPEP §
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`2114).
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`Regarding claims 24 & 25, Nagaoka et al. further teach the rotary analyzing device:
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`0
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`24.
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`wherein the liquid retaining connecting passage (221) has an elongate
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`body extending from an outer end to an inner end (see annotation in Fig. 8), with
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`

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`Application/Control Number: 15/941,836
`Art Unit: 1798
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`Page 8
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`the outer end being located closer to an outer periphery of the rotary analyzing
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`device (see Fig. 8 for example), the outer end of the liquid retaining connecting
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`passage having a radial location corresponding to a radial location of the second
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`end of the connecting passage (see a radial location near the radial position 402 in
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`Fig. 8), and the opened—to—atmosphere cavity with the air hole being disposed at
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`the inner end of the liquid retaining connecting passage (see Fig. 8 for example);
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`and
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`o
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`25.
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`wherein no air hole opened directly to atmosphere is formed in the
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`connecting passage (see ‘J[ 0080 & Fig. 8 for example).
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`Response to Arguments
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`Applicant's arguments filed 10/310/2019 have been fully considered but they are not
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`persuasive.
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`In response to the Applicant’s argument that “Nagaoka et al. fail to teach an opened—to—
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`atmosphere cavity connected to an outlet of the liquid retaining connecting passage, with an air
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`hole disposed in the opened—to—atmosphere cavity, allowing fluid communication between a
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`liquid retaining connecting passage and outside atmosphere through the opened—to—atmosphere
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`cavity”, Examiner disagrees.
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`Nagaoka et al. teach, among other things, an opened—to—atmosphere cavity (220)
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`connected to an outlet of the liquid retaining connecting passage (see Fig. 8); and an air hole
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`(222) disposed in the opened—to—atmosphere cavity (see Figs. 6 & 8 for example), allowing fluid
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`communication between the liquid retaining connecting passage and outside atmosphere through
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`

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`Application/Control Number: 15/941,836
`Art Unit: 1798
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`Page 9
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`the opened—to—atmosphere cavity (see i.e., “These vessels are connected to the atmosphere by
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`perforating the cover above these vent holes” 11 0050).
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`In response to the Applicant’s argument that “Nagaoka et al. merely discuss a perforator
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`13 used to perforate the cartridge cover 22 in that position, which corresponds to the vent hole
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`222 of the lysis reagent vessel 220. See Nagaoka et 211., paragraph [0063]”, the argument is not
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`found persuasive. It is noted that once the perforator is used to perforate the cartridge cover, the
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`present open—to—atmosphere cavity with an air hole required by claim 10 would be taught.
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`In response to the Applicant’s argument to the liquid retaining connecting passage to be
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`connected directly to the second end of the connecting passage to which the overflow cavity is
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`connected and extending toward an inner periphery of the rotary analyzing device, Nagaoka et al.
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`teach a liquid retaining connecting passage (221) connected directly to the second end of the
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`connecting passage to which the overflow cavity is connected and extending toward an inner
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`periphery of the rotary analyzing device (see Fig. 8 for example);
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`The 102 rejection as being anticipated by Saiki et al. is withdrawn.
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`Applicant is thanked for their thoughtful amendments to the claims.
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`Conclusion
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`The prior art made of record and not relied upon is considered pertinent to applicant's
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`disclosure.
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`Burd et al. (W0 91/ 18656) teach a rotor using a siphon 318 as the connecting means to
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`control flow between the metering chamber 292 and separation chamber 300. The elbow 320 of
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`the siphon 318 is positioned so that it is substantially the same distance from the center of the
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`rotor as the radially most inward point of the metering chamber 292 (Abstract & Fig. 24+).
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`

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`Application/Control Number: 15/941,836
`Art Unit: 1798
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`Page 10
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`Applicant's amendment necessitated the new ground(s) of rejection presented in this
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`Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a).
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`Applicant is reminded of the extension of time policy as set forth in 37 CFR l.l36(a).
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`A shortened statutory period for reply to this final action is set to expire THREE
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`MONTHS from the mailing date of this action. In the event a first reply is filed within TWO
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`MONTHS of the mailing date of this final action and the advisory action is not mailed until after
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`the end of the THREE—MONTH shortened statutory period, then the shortened statutory period
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`will expire on the date the advisory action is mailed, and any extension fee pursuant to 37
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`CFR l.l36(a) will be calculated from the mailing date of the advisory action. In no event,
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`however, will the statutory period for reply expire later than SIX MONTHS from the date of this
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`final action.
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to DEAN KWAK whose telephone number is (571)270—7072. The
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`examiner can normally be reached on M—TH, 5:30 am — 3:30 pm EST.
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`Examiner interviews are available via telephone, in—person, and video conferencing using
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`a USPTO supplied web—based collaboration tool. To schedule an interview, applicant is
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`encouraged to use the USPTO Automated Interview Request (AIR) at
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`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 A. 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 Patent
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`Application Information Retrieval (PAIR) system. Status information for published applications
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`

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`Application/Control Number: 15/941,836
`Art Unit: 1798
`
`Page 11
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`may be obtained from either Private PAIR or Public PAIR. Status information for unpublished
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`
`/DEAN KWAK/
`
`Primary Examiner, Art Unit 1798
`
`DEAN KWAK
`
`Primary Examiner
`Art Unit 1798
`
`