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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMIVHSSIONER FOR PATENTS
`PO. Box 1450
`Alexandria1 Virginia 22313-1450
`wwwusptogov
`
`
`
`
`
`14/666,231
`
`03/23/2015
`
`Koichi KOBAYASHI
`
`092122—0040
`
`4429
`
`20277
`7590
`0mm”
`MCDERMOTT WILL&EMERY LLP —
`The McDermott Building
`BOWERS, NATHAN ANDREW
`500 North Capitol Street, NW.
`WASHINGTON, DC 20001
`
`PAPER NUMBER
`
`1799
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`01/18/2017
`
`ELECTRONIC
`
`Please find below and/0r 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
`following e—mail address(es):
`
`ipdocketmwe @ mwe.com
`
`PTOL—90A (Rev. 04/07)
`
`

`

`
`Application No.
`Applicant(s)
`
` 14/666,231 KOBAYASHI ET AL.
`Examiner
`Art Unit
`AIA (First Inventorto File)
`Office Action Summary
`
`1799NATHAN BOWERS $233
`
`-- The MAILING DA TE of this communication appears on the cover sheet with 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).
`after SIX (6) MONTHS from the mailing date of this communication.
`If 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).
`
`In no event, however, may a reply be timely filed
`
`-
`-
`
`Status
`
`1)IXI Responsive to communication(s) filed on 23 March 2015.
`[I A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
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`2b)lX| This action is non-final.
`2a)I:| This action is FINAL.
`3)I:I An election was made by the applicant in response to a restriction requirement set forth during the interview on
`
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`; the restriction requirement and election have been incorporated into this action.
`
`4)|:I 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 EX parte Quay/e, 1935 CD. 11, 453 O.G. 213.
`
`3) D Interview Summary (PT0_413)
`1) E Notice of References Cited (PTO-892)
`Paper No(s)/Mai| Date.
`.
`.
`—
`4) I:I Other'
`2) E Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mai| Date See Continuation Sheet.
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mai| Date 20161006
`
`Disposition of Claims*
`5)|XI CIaim(s)1-_15is/are pending in the application.
`5a) Of the above claim(s)
`is/are withdrawn from consideration.
`6 III Claim s) _ is/are allowed.
`s 1-_15 is/are rejected.
`
`is/are objected to.
`
`) )
`
`_
`
`
`are subject to restriction and/or election requirement.
`9)|:l Claim(s
`)
`* 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
`htt ://\va.usoto. ov/ atents/init events"
`h/index.‘s
`
`
`
`
`
`, or send an inquiry to PF"I-Ifeedback{<‘buspto.qov.
`
`Application Papers
`
`10)I:I The specification is objected to by the Examiner.
`11)|:I The drawing(s) filed on _ is/are: a)I:I accepted or b)I:I 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)IZI Acknowledgment is made of a claim for foreign priority under 35 U.S.C. §119(a)-(d) or (f).
`Certified copies:
`
`b)I:I Some” c)I:I None of the:
`a)le All
`1.IZI Certified copies of the priority documents have been received.
`2.I:I Certified copies of the priority documents have been received in Application No.
`33.le Copies of the certified copies of the priority documents have been received in this National Stage
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`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)
`
`
`
`

`

`Continuation Sheet (PTOL-326)
`
`Application No. 14/666,231
`
`Continuation of Attachment(s) 2). Information Disclosure Statement(s) (PTO/SB/08), Paper No(s)/Mai| Date :3/23/2015, 5/2/2016,
`10/27/2015.
`
`

`

`Application/Control Number: 14/666,231
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`Page 2
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`Art Unit: 1799
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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.
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`Claim Rejections - 35 USC § 103
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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. Patentability shall not be
`negated by the manner in which the invention was made.
`
`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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`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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`

`

`Application/Control Number: 14/666,231
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`Page 3
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`Art Unit: 1799
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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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`Claims 1, 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable
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`over Yokoi (US 20100189607) in view of Ortner (US 20120040600).
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`With respect to claim 1, Yokoi discloses an isolator system comprising a main
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`body case include a substantially box-shaped work space (Figure 1 :10) isolated from its
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`surroundings. A spray device (Figure 1:200) to spray a sterilizing mist into the work
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`space. A diffusion fan (Figure 1 :48) is mounted within the main body and diffuses the
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`sterilizing mist after it has been sprayed into the work space. A control device (Figure
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`1:300, 310) is configured to control the operation of the spray device and the diffusion
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`fan. This is described in at least paragraphs [0024]-[0026]. The diffusion fan may be
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`programmed to be activated intermittently during the spray process and continuously
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`following the spray process. One of ordinary skill would have found it obvious to
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`continue operating the fan following spraying in order to thoroughly circulate the
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`sterilizing mist.
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`It is not completely clear whether the sterilizing supply port (Figure 1 :42)
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`is configured as a nozzle mounted within the main body case.
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`Ortner discloses a clean room comprising a main body case having a box-
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`shaped work space (Figure 1 :150). At least paragraph [0118] states that conduits
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`(Figure 2:266) are provided for delivering a chemical decontamination medium to the
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`

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`Application/Control Number: 14/666,231
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`Page 4
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`Art Unit: 1799
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`interior of the work space. Paragraphs [0036] and [0088] indicate that the
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`decontamination medium may be sprayed into the work space in a gaseous form or as
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`an aerosol using a spray head or nozzle.
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`Before the effective filing date of the claimed invention, it would have been
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`obvious to spray sterilizing mist into the Yokoi work space using a nozzle mounted
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`within the main body case. As evidenced by Ortner, spray heads, misters, nozzles, etc.
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`for carrying out a decontamination process are well known in the art. Combining prior
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`art elements according to known methods to yield predictable results is prima facie
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`obvious. See MPEP 2143.
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`With respect to claim 4, Yokoi and Ortner disclose the combination as described
`
`above. As previously stated, it would have been obvious to spray the sterilizing mist at
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`essentially any time (for example, intermittently). Alternatively, it is noted that
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`recitations of an intended use (here, when/how the spray nozzle can be operated) are
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`not afforded significant patentable weight when presented in the context of an
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`apparatus claim. Apparatus claims cover what a device is, not what a device does. A
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`claim containing a recitation with respect to the manner in which a claimed apparatus is
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`intended to be employed does not differentiate the claimed apparatus from a prior art
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`apparatus if the prior art apparatus teaches all the structural limitations of the claim.
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`See MPEP 2114.
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`

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`Application/Control Number: 14/666,231
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`Page 5
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`Art Unit: 1799
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`With respect to claim 5, Yokoi and Ortner disclose the combination as described
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`above. Yokoi teaches that a gas intake device (Figure 1 :18) is provided at an upper
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`portion of the main body case. A gas discharge device (Figure 1 :20) also provided.
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`Although the discharge device is shown as being at a lower portion of the main body
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`case, it would not function differently if it were provided at a different location, for
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`example at an upper portion of the main body case. Mere rearrangements of parts that
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`do not substantially affect device operation are considered to be prima facie obvious.
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`See MPEP 2144.04. The discharge device is fully capable of being used to release
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`pressure within the main body case during the spray process.
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`Claims 2, 3 and 6 are rejected under 35 U.S.C. 103 as being unpatentable
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`over Yokoi (US 20100189607) in view of Ortner (US 20120040600) as applied to
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`claim 1, and further in view of McVey (US 20050084415).
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`With respect to claim 2, Yokoi and Ortner disclose the isolator system in claim 1.
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`Although Yokoi describes that fans are used to distribute the sterilizing mist throughout
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`the main body case, Yokoi do not expressly state that the fans are positioned to spray
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`the mist substantially diagonally from an upper right or left location.
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`McVey discloses an isolator system comprising a main body case (Figure 1 :10)
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`and a vaporizer (Figure 1 :34) for delivering a hydrogen peroxide sterilizing mist into the
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`main body case. Paragraphs [0033]—[0038] state that a plurality of fans (Figure 1 :44)
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`are configured to distribute the mist throughout the isolator. From at least Figs. 1 and
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`8b, it is apparent that at least one fan is mounted the "upper right" side of the main body
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`

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`Application/Control Number: 14/666,231
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`Page 6
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`Art Unit: 1799
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`case. Paragraphs [0049], [0050] and [0062] describe how the operation of the fans is
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`regulated using a computer controller.
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`Before the effective filing date of the claimed invention, it would have been
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`obvious to arrange additional fans within the Yokoi isolator at essentially any location,
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`including at upper left and right corners of the main body case. As evidenced by
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`McVey, fans can be located and controlled to affect sterilizing mist dispersion in a
`
`desired manner.
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`Indeed, combining prior art elements according to known methods to
`
`yield predictable results is prima facie obvious. See MPEP 2143.
`
`With respect to claim 3, Yokoi, Ortner and McVey disclose the combination as
`
`described above. McVey additionally teaches that the spray device includes a water
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`suction tube controlled by a liquid delivery device — Le. a pump (Figure 9:122) —
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`configured to adjust the flow rate of the sterilizing liquid supplied from a container
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`(Figure 9:120). A nozzle at the flash evaporator (Figure 9:34) and/or injection port
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`(Figure 9:130) is configured to convert the liquid into a mist. A compressor (Figure
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`9:126, 100) is configured to deliver air into the nozzle to cause the sterilizing liquid to be
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`sprayed from the nozzle.
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`With respect to claim 6, Yokoi, Ortner and McVey disclose the combination as
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`described above. As previously described above, Yokoi shows in at least Fig. 8b that
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`fans 44 can cause airflow in at least two different directions.
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`

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`Application/Control Number: 14/666,231
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`Page 7
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`Art Unit: 1799
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`Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Yokoi
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`(US 20100189607) in view of Ortner (US 20120040600) as applied to claim 1, and
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`further in view of Fanning (US 20100062522).
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`Yokoi and Ortner disclose the isolator system as described above, however do
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`not appear to teach an air conditioning device provided outside the main body case.
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`Fanning discloses an isolator comprising a main body case (Figure 7:10) in
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`communication with an air conditioning unit (Figure 7:700, 702) provided outside of the
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`main body case. Fanning teaches throughout the reference that the air conditioning unit
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`produces cold air to maintain the temperature within the isolator at a desired level.
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`Before the effective filing date of the claimed invention, it would have been
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`obvious to provide the modified Yokoi isolator in communication with an air conditioning
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`device. Fanning teaches that external air conditioning devices may be used to
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`controllably regulate the temperature within an isolator, and that this can be particularly
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`important when the isolator is being used to culture cells. Combining prior art elements
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`according to known methods to yield predictable results is prima facie obvious. See
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`MPEP 2143.
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`Claims 8-15 are rejected under 35 U.S.C. 103 as being unpatentable over
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`Yokoi (US 20100189607) in view of Ortner (US 20120040600) and Fanning (US
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`20100062522) as applied to claim 7, and further in view of McVey (US
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`20050034415)
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`

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`Application/Control Number: 14/666,231
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`Page 8
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`Art Unit: 1799
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`With respect to claims 8, 12 and 13, Yokoi, Ortner and Fanning disclose the
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`isolator system in claim 7. Although Yokoi describes that fans are used to distribute the
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`sterilizing mist throughout the main body case, Yokoi do not expressly state that the
`
`fans are positioned to spray the mist substantially diagonally from an upper right or left
`
`location.
`
`McVey discloses an isolator system comprising a main body case (Figure 1 :10)
`
`and a vaporizer (Figure 1 :34) for delivering a hydrogen peroxide sterilizing mist into the
`
`main body case. Paragraphs [0033]-[0038] state that a plurality of fans (Figure 1 :44)
`
`are configured to distribute the mist throughout the isolator. From at least Figs. 1 and
`
`8b, it is apparent that at least one fan is mounted the "upper right" side of the main body
`
`case. Paragraphs [0049], [0050] and [0062] describe how the operation of the fans is
`
`regulated using a computer controller.
`
`Before the effective filing date of the claimed invention, it would have been
`
`obvious to arrange additional fans within the Yokoi isolator at essentially any location,
`
`including at upper left and right corners of the main body case. As evidenced by
`
`McVey, fans can be located and controlled to affect sterilizing mist dispersion in a
`
`desired manner.
`
`Indeed, combining prior art elements according to known methods to
`
`yield predictable results is prima facie obvious. See MPEP 2143.
`
`With respect to claims 9-11, Yokoi, Ortner, Fanning and McVey disclose the
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`combination as described above. One of ordinary skill would have found it obvious to
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`operate the Yokoi fans at any time periods, including intermittently. This would simply
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`

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`Application/Control Number: 14/666,231
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`Page 9
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`Art Unit: 1799
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`involve programming the controller with a predetermined a start/stop protocol. For
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`example, paragraphs [0049], [0050] and [0062] of McVey describe how it is known in
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`the art to operate isolator fans to disperse sterilizing mist in a predictable manner.
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`With respect to claim 14, Yokoi, Ortner, Fanning and McVey disclose the
`
`combination as described above. McVey additionally teaches that the spray device
`
`includes a water suction tube controlled by a liquid delivery device — Le. a pump (Figure
`
`9:122) — configured to adjust the flow rate of the sterilizing liquid supplied from a
`
`container (Figure 9:120). A nozzle at the flash evaporator (Figure 9:34) and/or injection
`
`port (Figure 9:130) is configured to convert the liquid into a mist. A compressor (Figure
`
`9:126, 100) is configured to deliver air into the nozzle to cause the sterilizing liquid to be
`
`sprayed from the nozzle.
`
`With respect to claim 15, Yokoi, Ortner, Fanning and McVey disclose the
`
`combination as described above. Yokoi teaches that a gas intake device (Figure 1 :18)
`
`is provided at an upper portion of the main body case. A gas discharge device (Figure
`
`1:20) also provided. Although the discharge device is shown as being at a lower portion
`
`of the main body case, it would not function differently if it were provided at a different
`
`location, for example at an upper portion of the main body case. Mere rearrangements
`
`of parts that do not substantially affect device operation are considered to be prima
`
`facie obvious. See MPEP 2144.04. The discharge device is fully capable of being used
`
`to release pressure within the main body case during the spray process.
`
`

`

`Application/Control Number: 14/666,231
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`Page 10
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`Art Unit: 1799
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`Conclusion
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`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to NATHAN BOWERS whose telephone number is
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`(571)272-8613. The examiner can normally be reached on Monday-Friday 7 AM to 4
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`PM.
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
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`supervisor, Michael Marcheschi can be reached on (571) 272-1374. The fax phone
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`number for the organization where this application or proceeding is assigned is 571 -
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`273-8300.
`
`Information regarding the status of an application may be obtained from the
`
`Patent Application Information Retrieval (PAIR) system. Status information for
`
`published applications may be obtained from either Private PAIR or Public PAIR.
`
`Status information for unpublished applications is available through Private PAIR only.
`
`For more information about the PAIR system, see http://pair-direct.uspto.gov. Should
`
`you have questions on access to the Private PAIR system, contact the Electronic
`
`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—1000.
`
`/NATHAN BOWERS/
`
`Primary Examiner, Art Unit 1799
`
`