`
`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
`
`03/19/2014
`
`Yasuhiko YOKOI
`
`061282—0439
`
`4840
`
`McDermott Will and Emery LLP
`The McDermott Building
`500 North Capitol Street, NW.
`WASHINGTON, DC 20001
`
`CONLEY’ SEAN EVERETT
`
`1799
`
`PAPER NUMBER
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`NOTIFICATION DATE
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`DELIVERY MODE
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`04/06/2016
`
`ELECTRONIC
`
`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.
`
`
`AIA (First Inventor to File)
`Art Unit
`Examiner
`Office Action Summary
`
`
`SEAN E. CONLEY its“ 1799
`-- 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 (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
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`Status
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`1)IZI Responsive to communication(s) filed on 3/19/14.
`El A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
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`2b)|Z| 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.
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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 C|aim(s) fl 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 El Claim s)
`s fl is/are rejected.
`
`3) D Interview Summary (PTO-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)
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`Paper No(s)/Mai| Date .
`US. Patent and Trademark Office
`PTOL—326 (Rev. 11-13)
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`Office Action Summary
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`Part of Paper No./Mai| Date 20160329
`
`) )
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`_
`
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`is/are objected to.
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`are subject to restriction and/or election requirement.
`9)I:I C|aim(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
`
`
`
`
`hit
`:i/wwwusnto. ov/ atentS/init events/
`iindex.‘s orsend an inquiry to PPI-iieedback{®usgtc.00v.
`
`Application Papers
`
`10)I:l The specification is objected to by the Examiner.
`11)|Xl The drawing(s) filed on 3/19/14 is/are: a)IZI 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)IXI 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)IZl All
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`b)|:l Some” c)I:l None of the:
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`1.IXI 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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`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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`Claim Rejections - 35 USC § 102
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`2.
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`The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C.
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`102 that form the basis for the rejections under this section made in this Office action:
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`A person shall be entitled to a patent unless —
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`(b) the invention was patented or described in a printed publication in this or a foreign country
`or in public use or on sale in this country, more than one year prior to the date of application
`for patent in the United States.
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`3.
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`Claims 13-16, 18, 23-26, and 29-31 are rejected under pre-AIA 35 U.S.C. 102(b)
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`as being anticipated by Bondar (US 2008/0080999 A1).
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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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`

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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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`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 [0029]-[0034] —
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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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`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 [0029]-[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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`

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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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`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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`Claim Rejections - 35 USC § 103
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`4.
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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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`5.
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`Claim 17 is rejected under 35 U.S.C. 103(a) as being unpatentable over Bondar
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`as applied to claim 13 above, and further in view of Mueller (US 5,792,435).
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`Bondar is set forth above with regards to claim 13. Bondar does not appear to
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`explicitly disclose that the components of the sterilizer are contained within a housing.
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`However, Mueller teaches an isolator system for decontamination of objects wherein the
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`decontamination chamber and gas supply system, and gas generator are all contained
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`within a housing (see figure 1
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`; see col. 3). Therefore, it would have been obvious to
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`one of ordinary skill in the art at the time the invention was made to modify the sterilizer
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`of Bondar and include a housing that contains all of the components of the system,
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`including the gas generator, sterilization chamber, and gas supply system as taught by
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`Mueller in order to provide a single integrated unit for sterilizing objects.
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`

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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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`Double Patenting
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`6.
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`The nonstatutory double patenting rejection is based on a judicially created
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`doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the
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`unjustified or improper timewise extension of the “right to exclude” granted by a patent
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`and to prevent possible harassment by multiple assignees. A nonstatutory double
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`patenting rejection is appropriate where the claims at issue are not identical, but at least
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`one examined application claim is not patentably distinct from the reference claim(s)
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`because the examined application claim is either anticipated by, or would have been
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`obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d
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`1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir.
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`1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum,
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`686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619
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`(CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
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`A timely filed terminal disclaimer in compliance with 37 CFR 1.321 (c) or 1.321(d)
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`may be used to overcome an actual or provisional rejection based on a nonstatutory
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`double patenting ground provided the reference application or patent either is shown to
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`be commonly owned with this application, or claims an invention made as a result of
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`activities undertaken within the scope of a joint research agreement. See MPEP §
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`717.02 for applications subject to examination under the first inventor to file provisions
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`of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for
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`applications not subject to examination under the first inventor to file provisions of the
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`AIA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321 (b).
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`

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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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`The USPTO Internet website contains terminal disclaimer forms which may be
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`used. Please visit www.uspto.gov/forms/. The filing date of the application in which the
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`form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AlA/25, or
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`PTO/AlA/26) should be used. A web-based eTerminal Disclaimer may be filled out
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`completely online using web-screens. An eTerminal Disclaimer that meets all
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`requirements is auto-processed and approved immediately upon submission. For more
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`information about eTerminal Disclaimers, refer to
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`
`htt
`://www.us to. ov/ atents/ rocess/fiie/efs/ uidance/eTD—info—l.”s .
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`7.
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`Claims 13-31 are rejected on the ground of nonstatutory double patenting as
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`being unpatentable over claims 1-18 of U.S. Patent No. 8,721,983 B2 in view of Bondar
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`(US 2008/0080999 A1).
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`Claims 1-18 of U.S. Patent No. 8,721,983 B2 discloses all of the features of
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`present claims 13-31 except for specifically reciting that the “sterilization gas, air or a
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`mixture thereof is discharged from the sterilization chamber, bypasses the sterilization
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`gas generator and returns to the sterilization chamber.” U.S. Patent No. 8,721,983 B2
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`claims that the sterilization gas, air or mixture circulates through the circulator and
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`bypasses the sterilization gas generator (see claims). Bondar discloses that the in-line
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`circulator (34 or 72) is used to transfer the sterilizing gas into and out of the sterilization
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`chambers while bypassing the sterilization gas generator (see para [0030]-[0032] and
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`figure 2).
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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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`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 US. Patent No. 8,721,983 to
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`provide the ability to use the inline circulator to circulate the sterilization gas into and out
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`of the sterilization chambers while bypassing the gas generator in order to transfer
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`sterilizing gas back and forth between multiple chambers.
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`Conclusion
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`8.
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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 571 -272—
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`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—1374. 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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`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).
`
`/SEAN E CONLEY/
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`Primary Examiner, Art Unit 1799
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`