`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMlVHSSIONER FOR PATENTS
`PO. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`
`
`
`
`13/457,675
`
`04/27/2012
`
`Yasuhiko YOkOi
`
`120508
`
`1066
`
`06/30/2016 —WESTERMAN, HATTORI, DANIELS & ADRIAN, LLP m
`7590
`38834
`1250 CONNECTICUT AVENUE, NW
`BOWERS’ NATHAN ANDREW
`SUITE 700
`WASHINGTON, DC 20036
`
`PAPER NUMBER
`
`1799
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`06/3 0/2016
`
`ELECTRONIC
`
`Please find below and/or 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):
`
`patentmail @ tha.c0m
`
`PTOL—90A (Rev. 04/07)
`
`

`

`
`Application No.
`Applicant(s)
`
` 13/457,675 YOKOI ET AL.
`Examiner
`Art Unit
`AIA (First Inventorto File)
`Office Action Summary
`
`1799NATHAN BOWERS first“
`
`-- 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
`
`-
`-
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`Status
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`1)IXI Responsive to communication(s) filed on 03 March 2016.
`[I A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
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`2b)|:| This action is non-final.
`2a)IZ| 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.
`
`Disposition of Claims*
`
`5)IXI C|aim(s) 12 4 5 78 and 10-12 is/are pending in the application.
`5a) Of the above claim(s)
`is/are withdrawn from consideration.
`6 III Claim s) _ is/are allowed.
`
`12 4 5 7 8 and 10-12 is/are rejected.
`
`is/are objected to.
`
`
`
`are subject to restriction and/or election requirement.
`* 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
` S
`htt ://\va.usoto. ov/ atents/init events) .h/index.‘
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`
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`, 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)I:I 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)I:I All
`1.I:I Certified copies of the priority documents have been received.
`2.I:I Certified copies of the priority documents have been received in Application No.
`3.I:I 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)
`
`
`
`3) D Interview Summary (PT0_413)
`1) D Notice of References Cited (PTO-892)
`Paper No(s)/Mai| Date.
`.
`.
`—
`4) I:I Other'
`2) D Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`
`Paper No(s)/Mai| Date .
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mai| Date 20160622
`
`

`

`Application/Control Number: 13/457,675
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`Page 2
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`Art Unit: 1799
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`DETAILED ACTION
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`Claim Rejections - 35 USC § 103
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`The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis
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`for all obviousness rejections set forth in this Office action:
`
`(a) A patent may not be obtained though the invention is not identically disclosed or described
`as set forth in section 102 of this title, if the differences between the subject matter sought to
`be patented and the prior art are such that the subject matter as a whole would have been
`obvious at the time the invention was made to a person having ordinary skill in the art to which
`said subject matter pertains. Patentability shall not be negatived by the manner in which the
`invention was made.
`
`The factual inquiries set forth in Graham v. John Deere 00., 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter
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`of the various claims was commonly owned at the time any inventions covered therein
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`were made absent any evidence to the contrary. Applicant is advised of the obligation
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`under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was
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`not commonly owned at the time a later invention was made in order for the examiner to
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`

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`Application/Control Number: 13/457,675
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`Page 3
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`Art Unit: 1799
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`consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C.
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`102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
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`Claims 1, 2, 4, 5, 7, 8 and 10-12 are rejected under pre-AIA 35 U.S.C. 103(a)
`
`as being unpatentable over Herbert (US 20100291664) in view of Cox (US
`
`3907389) and Barbera-Guillem (US 20030040104).
`
`With respect to claim 1, Herbert discloses an isolator comprising a working
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`chamber (Figure 1:3,6,9,11,13) having a culture apparatus (Figure 2:21) mounted to an
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`exterior surface of the working chamber. The working chamber additionally includes at
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`least one opening (Figure 1:41) configured to attach a working glove, as well as another
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`opening configured to allow a culture chamber (Figure 3:24) of the culture apparatus to
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`communicate with the working chamber. The working chamber is also connected to a
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`storage chamber (Figure 1:2) via another door (Figure 2:26). The storage chamber has
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`still another exterior door (Figure 2:28) that can open and close to permit
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`communication with an exterior environment. This is described in at least paragraphs
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`[0027]-[0029]. Herbert, however, does not appear to teach that the culture apparatus is
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`demountably (i.e. “detachably” or “reversibly”) mounted.
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`Cox discloses an isolator comprising a working chamber (Figure 1:12) having a
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`culture apparatus (Figure 1 :43,44) and a storage chamber (Figure 1 :62) attached
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`thereto. Column 5, line 40 to column 6, line 43 states that the culture apparatus is
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`demountably mounted to the working chamber using slide edges (Figure 7:56) that
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`interact with guide rails (Figure 7:52,53). See Fig. 7.
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`Application/Control Number: 13/457,675
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`Page 4
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`Art Unit: 1799
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`At the time of the invention, it would have been obvious to demountably mount
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`the Herbert culture apparatus to the working chamber using reversible connection
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`means. For example, Cox shows that this could be accomplished using a simple sliding
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`mechanism. One of ordinary skill would have understood that this would have allowed
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`one to load and operate the culture apparatus at a remote location, and attach it to the
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`working chamber only when it is necessary to transfer the cellular contents.
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`It is prima
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`facie obvious to combine prior art elements according to known methods to yield
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`predictable results. See MPEP 2143.
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`Herbert and Cox still differ from Applicant’s claimed invention because Herbert
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`does not expressly teach a temperature adjusting device suited for cell culture.
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`Barbera-Guillem discloses an automated cell management system comprising a
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`working chamber (Figure 1:10) configured to hold cell culture dishes on a storage
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`carousel (Figure 1 :20). Paragraphs [0004] and [0037] state that a temperature
`
`adjusting device (Figure 2:16) is used to optimize cell growth conditions.
`
`At the time of the invention, it would have been obvious to provide the Herbert
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`system with a temperature control device when the working chamber is used to process
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`cells or any other temperature sensitive material. Barbera-Guillem teaches that
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`temperature, humidity, gas content, pressure and airflow control are all notoriously well
`
`known in the isolator system art. Again, it is prima facie obvious to combine prior art
`
`elements according to known methods to yield predictable results. See MPEP 2143.
`
`

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`Application/Control Number: 13/457,675
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`Page 5
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`Art Unit: 1799
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`With respect to claim 2, Herbert, Cox and Barbera-Guillem disclose the
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`combination as described above. Cox additionally teaches that a door (Figure 7:51) is
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`used to close the opening to the between the working chamber and the culture chamber
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`when the culture apparatus is demounted.
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`With respect to claims 4 and 5, Herbert, Cox and Barbera-Guillem disclose the
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`combination as described above. Barbera-Guillem additionally teaches gas
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`concentration control (i.e. carbon dioxide adjustment) in at least paragraph [0037].
`
`With respect to claims 7, 8 and 10, Herbert, Cox and Barbera-Guillem disclose
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`the combination as described above. Barbera-Guillem additionally teaches humidity
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`control (i.e. water vapor content) in at least paragraph [0037].
`
`With respect to claim 11, Herbert, Cox and Barbera-Guillem disclose the
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`combination as described above. Herbert discloses a corresponding method in which
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`there is a first process of moving the culture in the culture chamber to the working
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`chamber via an opening and an associated door 49. Herbert teaches a second process
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`of closing the door and hermetically sealing the working chamber. As previously
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`discussed, Barbera-Guillem teaches a third process of adjusting the temperature using
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`a temperature control device. As previously discussed, Cox teaches a fourth process of
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`demounting the culture apparatus. Cox also teaches a fifth process and sixth process
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`of mounting a second culture apparatus (Fig. 1 of Cox shows two mounted culture
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`

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`Application/Control Number: 13/457,675
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`Page 6
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`Art Unit: 1799
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`apparatuses 43, 44) and allowing the contents of the second culture apparatus to enter
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`into the working chamber. Both the first and second culture apparatuses are
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`demountably mounted to the exterior of the working chamber using a similar coupling
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`member (see Fig. 7).
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`With respect to claim 12, Herbert, Cox and Barbera-Guillem disclose the
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`combination as described above. Herbert discloses a corresponding method in which
`
`there is a first process of moving a culture from the culture chamber into the working
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`chamber, and then moving the culture from the working chamber into the storage
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`chamber. Herbert teaches a second process of closing the doors to the storage and
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`culture chambers in order to hermetically seal the working chamber. As previously
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`discussed, Barbera-Guillem teaches a third process of adjusting the temperature using
`
`a temperature control device. As previously discussed, Cox teaches a fourth process of
`
`demounting the culture apparatus. Cox also teaches a fifth process of mounting a
`
`second culture apparatus (Fig. 1 of Cox shows two mounted culture apparatuses 43,
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`44). Barbera-Guillem discloses a sixth process of causing a decontamination material
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`supply device (Figure 8:140) to decontaminate the working chamber and the culture
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`chamber(s). See paragraphs [0066] and [0067]. Herbert and Cox each teach a
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`seventh process in which a culture can be moved back into the working chamber and
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`then back into a respective culture chamber.
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`

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`Application/Control Number: 13/457,675
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`Page 7
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`Art Unit: 1799
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`Claims 1, 2, 4, 5, 7, 8 and 10-12 are rejected under pre-AIA 35 U.S.C. 103(a)
`
`as being unpatentable over Cox (US 3907389) in view of Barbera-Guillem (US
`
`20030040104).
`
`With respect to claim 1, Cox discloses an isolator comprising a working chamber
`
`(Figure 1 :12) having a culture apparatus (Figure 1 :43,44) and a storage chamber
`
`(Figure 1:62) attached thereto. Column 5, line 40 to column 6, line 43 states that the
`
`culture apparatus is demountably mounted to the working chamber using slide edges
`
`(Figure 7:56) that interact with guide rails (Figure 7:52,53). See Fig. 7. The working
`
`chamber additionally includes at least one opening configured to attach a working glove
`
`(Figure 1:33), as well as another opening configured to allow a culture chamber of the
`
`culture apparatus to communicate with the working chamber. The working chamber is
`
`also connected to a storage chamber via a door (Figure 1 :64). The storage chamber
`
`has still another exterior door (Figure 1:66) that can open and close to permit
`
`communication with an exterior environment. Cox, however, does not expressly teach a
`
`temperature adjusting device suited for cell culture.
`
`Barbera-Guillem discloses an automated cell management system comprising a
`
`working chamber (Figure 1:10) configured to hold cell culture dishes on a storage
`
`carousel (Figure 1 :20). Paragraphs [0004] and [0037] state that a temperature
`
`adjusting device (Figure 2:16) is used to optimize cell growth conditions.
`
`At the time of the invention, it would have been obvious to provide the Cox
`
`system with a temperature control device when the working chamber is used to process
`
`cells or any other temperature sensitive material. Barbera-Guillem teaches that
`
`

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`Application/Control Number: 13/457,675
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`Page 8
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`Art Unit: 1799
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`temperature, humidity, gas content, pressure and airflow control are all notoriously well
`
`known in the isolator system art.
`
`It is prima facie obvious to combine prior art elements
`
`according to known methods to yield predictable results. See MPEP 2143.
`
`With respect to claim 2, Cox and Barbera-Guillem disclose the combination as
`
`described above. Cox additionally teaches that a door (Figure 7:51) is used to close the
`
`opening to the between the working chamber and the culture chamber when the culture
`
`apparatus is demounted.
`
`With respect to claims 4 and 5, Cox and Barbera-Guillem disclose the
`
`combination as described above. Barbera-Guillem additionally teaches gas
`
`concentration control (i.e. carbon dioxide adjustment) in at least paragraph [0037].
`
`With respect to claims 7, 8 and 10, Cox and Barbera-Guillem disclose the
`
`combination as described above. Barbera-Guillem additionally teaches humidity control
`
`(i.e. water vapor content) in at least paragraph [0037].
`
`With respect to claim 11, Cox and Barbera-Guillem disclose the combination as
`
`described above. Cox discloses a corresponding method in which there is a first
`
`process of moving the culture in the culture chamber to the working chamber via an
`
`opening and an associated door. Cox teaches a second process of closing the door
`
`and hermetically sealing the working chamber. As previously discussed, Barbera-
`
`

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`Application/Control Number: 13/457,675
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`Page 9
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`Art Unit: 1799
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`Guillem teaches a third process of adjusting the temperature using a temperature
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`control device. As previously discussed, Cox teaches a fourth process of demounting
`
`the culture apparatus. Cox also teaches a fifth process and sixth process of mounting a
`
`second culture apparatus (Fig. 1 of Cox shows two mounted culture apparatuses 43,
`
`44) and allowing the contents of the second culture apparatus to enter into the working
`
`chamber. Both the first and second culture apparatuses are demountably mounted to
`
`the exterior of the working chamber using a similar coupling member (see Fig. 7).
`
`With respect to claim 12, Cox and Barbera-Guillem disclose the combination as
`
`described above. Cox discloses a corresponding method in which there is a first
`
`process of moving a culture from the culture chamber into the working chamber, and
`
`then moving the culture from the working chamber into the storage chamber. Cox
`
`teaches a second process of closing the doors to the storage and culture chambers in
`
`order to hermetically seal the working chamber. As previously discussed, Barbera-
`
`Guillem teaches a third process of adjusting the temperature using a temperature
`
`control device. As previously discussed, Cox teaches a fourth process of demounting
`
`the culture apparatus. Cox also teaches a fifth process of mounting a second culture
`
`apparatus (Fig.
`
`1 of Cox shows two mounted culture apparatuses 43, 44). Barbera-
`
`Guillem discloses a sixth process of causing a decontamination material supply device
`
`(Figure 8:140) to decontaminate the working chamber and the culture chamber(s). See
`
`paragraphs [0066] and [0067]. Cox teaches a seventh process in which a culture can
`
`

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`Application/Control Number: 13/457,675
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`Page 10
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`Art Unit: 1799
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`be moved back into the working chamber and then back into a respective culture
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`chamber.
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`Response to Arguments
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`In response to Applicant’s amendments filed 03 March 2016, new grounds of
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`rejection are made in view of the combination of Herbert with Cox and Barbera-Guillem
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`and in view of the combination of Cox with Barbera-Guillem.
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`Conclusion
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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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`

`

`Application/Control Number: 13/457,675
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`Page 11
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`Art Unit: 1799
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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
`
`(571)272-8613. The examiner can normally be reached on Monday-Friday 7 AM to 4
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`PM.
`
`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.
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`
`/NATHAN BOWERS/
`
`Primary Examiner, Art Unit 1799
`
`