`
`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
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`
`
`
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`14/219,660
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`03/19/2014
`
`Yasuhiko YOKOI
`
`061282—0439
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`4840
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`McDermott Will and Emery LLP
`The McDermott Building
`500 North Capitol Street, NW.
`WASHINGTON, DC 20001
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`CONLEY’ SEAN EVERETT
`
`1799
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`PAPER NUMBER
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`NOTIFICATION DATE
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`DELIVERY MODE
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`11/03/2016
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`ELECTRONIC
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`Please find below and/0r 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
`following e—mail address(es):
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`mweipdocket @ mwe.com
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`PTOL—90A (Rev. 04/07)
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`

`

`
`
`Applicant(s)
`Application No.
` 14/219,660 YOKOI ET AL.
`
`Examiner
`Art Unit
`AIA (First Inventor to File)
`Office Action Summary
`
`1799SEAN E. CONLEY its“
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`-- 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 CFR1. 136( a).
`after SIX () 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
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`Status
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`1)IZI Responsive to communication(s) filed on 7/5/16.
`El A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
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`2b)|:l This action is non-final.
`2a)|Z| 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.
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`4)|:| Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
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`closed in accordance with the practice under Exparte Quay/e, 1935 CD. 11, 453 O.G. 213.
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`Disposition of Claims*
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`5)IZI Claim(s) 13-31 is/are pending in the application.
`5a) Of the above claim(s)
`is/are withdrawn from consideration.
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`is/are allowed.
`6)I:I Claim(s)
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`7)|Z| Claim(s 13-18 23-26 29-31 is/are rejected.
`)
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`8)|Z| Claim(s) 19-22 27 and 28 is/are objected to.
`
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`are subject to restriction and/or election requirement.
`9)I:I Claim((s)
`* 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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`
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`:/'/\W¢W.LISI>I‘.0. ovI’ atentS/init events/
`hI/index.‘s orsend an inquiryto PPI-iieedback{®usgtc.00v.
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`hit
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`Application Papers
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`10)I:l The specification is objected to by the Examiner.
`11)I:l 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).
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`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)I:| 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:l All
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`b)|:l Some” c)I:l None of the:
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`1.I:I Certified copies of the priority documents have been received.
`2.|:l Certified copies of the priority documents have been received in Application No.
`3.|:| 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.
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`Attachment(s)
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`
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`3) D Interview Summary (PTO-413)
`1) E Notice of References Cited (PTO-892)
`Paper No(s)/Mai| Date.
`.
`.
`4) I:I Other'
`2) I] InformatIon DIsclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mai| Date
`US. Patent and Trademark Office
`PTOL—326 (Rev. 11-13)
`
`Office Action Summary
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`Part of Paper No./Mai| Date 20161031
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`

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`Application/Control Number: 14/219,660
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`Page 2
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`Art Unit: 1799
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`DETAILED ACTION
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`1.
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`The present application is being examined under the pre-AIA first to invent
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`provisions.
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`2.
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`The amendment filed July 5, 2016 has been received and considered for
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`examination. Claims 13-31 are presently pending.
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`Terminal Disclaimer
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`3.
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`The terminal disclaimer filed on July 5*, 2016 disclaiming the terminal portion of
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`any patent granted on this application which would extend beyond the expiration date of
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`8,721,983 has been reviewed and is accepted. The terminal disclaimer has been
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`recorded.
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`Response to Arguments
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`4.
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`Applicant’s arguments with respect to the rejections under 35 USC 102/103 have
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`been considered but are moot in view f the new grounds of rejection. The newly cited
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`prior art of Masuda has been relied upon to teach the new limitations from original claim
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`20 that have been added to independent claim 13.
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`A new search was necessitated
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`due to only a portion of claim 20 being added to claim 13.
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`The double patenting rejection is withdrawn in view of the Terminal Disclaimer
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`filed July 5th, 2016.
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`

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`Application/Control Number: 14/219,660
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`Page 3
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`Art Unit: 1799
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`Claim Rejections - 35 USC § 103
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`5.
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`The text of those sections of Title 35, U.S. Code not included in this action can
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`be found in a prior Office action.
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`6.
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`Claims 13-16, 18, 23-26 and 29-31 are rejected under pre-AlA 35 U.S.C. 103(a)
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`as being unpatentable over Bondar (US 2008/0080999 A1) in view of Masuda (U.S.
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`Patent No. 5,120,512).
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`Regarding claims 13, 25, and 31, Bondar discloses a sterilizer comprising a
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`sterilization gas generator (vaporizer 74) configured to generate sterilization gas (ETO
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`gas); a sterilization chamber (chamber A, 50); and a gas supply system comprising:
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`a first gas supply system (portion of line 54 from vaporizer to chamber A) configured to
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`supply the sterilization gas from the sterilization gas generator to the sterilization
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`chamber; and a second gas supply system (portion of line 54 connecting vaporizer 74 to
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`sterilizer B) configured to supply the sterilization gas from the sterilization gas generator
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`to the external chamber (Sterilizer B, 4); and a first circulation system (lines connected
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`to ports 52 in chamber A) configured to circulate the sterilization gas, air, or a mixture
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`thereof in the sterilization chamber, wherein the first circulation system comprises an in-
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`line circulator (72) configured to circulate sterilization gas, air or mixture thereof through
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`the inline circulator such that said sterilization gas, air or a mixture thereof is discharged
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`from the sterilization chamber (A), bypasses the sterilization gas generator (vaporizer
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`24) and returns to the sterilization chamber (see figure 2; see para [OO29]—[0034] —
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`Application/Control Number: 14/219,660
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`Page 4
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`Art Unit: 1799
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`especially para [0030] —circu|ation blowers 34, 72 configured to facilitate gas flow
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`between the sterilization chambers 4 and 50).
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`However, Bondar does not appear to disclose that the sterilization chamber has
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`a gas discharging port separately provided from the gas feeding port (Bondar appears
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`to only disclose a single port (end of line 54) and a circulator 34) wherein the
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`sterilization agent is circulated from the discharging port and back to the feeding port
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`while bypassing the gas generator.
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`Masuda discloses an apparatus for sterilizing objects wherein the apparatus
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`includes a sterilization chamber (1) having a gas inlet port (3) and a gas outlet port (14),
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`wherein the sterilization gas is exhausted from the chamber via port (14) using
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`circulation pump (16) and passed back into the sterilization chamber (1) via gas inlet (3)
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`in order to circulate the sterilization gas in the chamber (see figures 1 and 8; see col. 8,
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`lines 55-60). Masuda also disclose that the sterilization gas can be recirculated via
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`discharge port (9), through pump (38) and back into the chamber (1) via gas inlet (13)
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`(see col. 6, line 53 to col 7, line 37). Therefore, Masuda teaches the concept of
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`recirculating a sterilization gas by having the gas exit the chamber via a discharge port,
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`pass through and in-line circulator, and reenter the chamber via a gas inlet port.
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`Therefore, it would have been obvious to one of ordinary skill in the art at the
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`time the invention was made to modify the sterilizer of Bondar and substitute the gas
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`circulation system of Bondar with a functionally equivalent alternative means
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`(sterilization chamber having a gas discharge port, a separate gas feeding port, and an
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`Application/Control Number: 14/219,660
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`Page 5
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`Art Unit: 1799
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`in-line circulator) in order to yield the predictable result of recirculating the sterilization
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`gas into and out of the sterilization chamber.
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`Regarding claims 14 and 15, Bondar discloses a gas feeding port (location where
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`line 54 enters into sterilizer A) (see figure 2). The location where gas supply line (8)
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`enters into sterilizer B is considered to be the gas outlet port that is capable of supplying
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`the sterilization gas to the external chamber (sterilizer B) (see figure 2).
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`Regarding claim 16, Bondar discloses that the chambers include doors (see
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`figure 2).
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`Regarding claim 18, Bondar discloses multiple gas outlet ports for supplying
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`sterilization gas to a plurality of chambers (see figures 2 and 3 - the ports being the
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`location at which the gas conduit enters into the chambers).
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`Regarding claims 23 and 24, the external chamber (sterilization chamber B) is
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`capable of being used as a cell manipulation chamber or an isolator.
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`Regarding claim 26, the device of Bondar includes a controller (valves 64, 36)
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`that are capable of being used to switch operation between supply and circulation (see
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`figure 2; see para [OO29]—[0030]).
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`Regarding claims 29 and 30, Bondar discloses a first substitution system (air
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`supply that passes through filter (62) to produce filtered air) (see figure 2, para [0029]).
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`the air filter (62) is capable of being sterilized by the gas supply system and circulation
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`system by operating the appropriate valves (see figure 2).
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`Application/Control Number: 14/219,660
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`Page 6
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`Art Unit: 1799
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`7.
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`Claim 17 is rejected under 35 U.S.C. 103(a) as being unpatentable over Bondar
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`in view of Masuda as applied to claim 13 above, and further in view of Mueller (US
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`5,792,435).
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`The combination of Bondar and Masuda is set forth above with regards to claim
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`13. Bondar does not appear to explicitly disclose that the components of the sterilizer
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`are contained within a housing. However, Mueller teaches an isolator system for
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`decontamination of objects wherein the decontamination chamber and gas supply
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`system, and gas generator are all contained within a housing (see figure 1
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`; see col. 3).
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`Therefore, it would have been obvious to one of ordinary skill in the art at the time the
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`invention was made to modify the sterilizer of the combination of Bondar and Masuda
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`include a housing that contains all of the components of the system, including the gas
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`generator, sterilization chamber, and gas supply system as taught by Mueller in order to
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`provide a single integrated unit for sterilizing objects.
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`Allowable Subject Matter
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`8.
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`Claims 19-22 and 27-28 are objected to as being dependent upon a rejected
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`base claim, but would be allowable if rewritten in independent form including all of the
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`limitations of the base claim and any intervening claims.
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`The prior art, alone or in combination, fails to teach or suggest, in the claimed
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`environment, the limitations of dependent claims 19-22 and 27-28.
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`Conclusion
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`

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`Application/Control Number: 14/219,660
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`Page 7
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`Art Unit: 1799
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`9.
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`Applicant's amendment necessitated the new ground(s) of rejection presented in
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`this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP
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`§ 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37
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`CFR1.136(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.
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`In the event a first reply is filed within
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`TWO MONTHS of the mailing date of this final action and the advisory action is not
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`mailed until after the end of the THREE-MONTH shortened statutory period, then the
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`shortened statutory period will expire on the date the advisory action is mailed, and any
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`extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of
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`the advisory action.
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`In no event, however, will the statutory period for reply expire later
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`than SIX MONTHS from the date of this 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 SEAN E. CONLEY whose telephone number is
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`(571 )272—8414. The examiner can normally be reached on M-F 8:30-5:00.
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
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`supervisor, Mike Marcheschi can be reached on 571 -272—1 374. The fax phone number
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`for the organization where this application or proceeding is assigned is 571-273-8300.
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`

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`Application/Control Number: 14/219,660
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`Page 8
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`Art Unit: 1799
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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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`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).
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`/SEAN E CONLEY/
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`Primary Examiner, Art Unit 1799
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`