`
`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
`
`11/05/2015 —WESTERMAN, HATTORI, DANIELS & ADRIAN, LLP m
`7590
`38834
`1250 CONNECTICUT AVENUE, NW
`EDWARDS’ LYDIAE
`SUITE 700
`WASHINGTON, DC 20036
`
`PAPER NUMBER
`
`1799
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`11/05/2015
`
`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)
`
`

`

`
`
`Applicant(s)
`Application No.
` 13/457,675 YOKOI ET AL.
`
`Examiner
`Art Unit
`AIA (First Inventor to File)
`Office Action Summary
`
`LYDIA EDWARDS 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 () 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)IZI Responsive to communication(s) filed on 8/31/2015.
`El A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`2b)|ZI This action is non-final.
`2a)|:l This action is FINAL.
`3)|:I An election was made by the applicant in response to a restriction requirement set forth during the interview on
`
`; the restriction requirement and election have been incorporated into this action.
`
`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.
`
`Disposition of Claims*
`
`5)IZI Claim(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)|:I Claim(s)
`is/are allowed.
`
`7)|Z| Claim(s) 124 5 78 and 10- 12is/are rejected.
`8)|:I Claim(s)_ is/are objected to.
`
`
`are subject to restriction and/or election requirement.
`9)|:I 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
`hit
`:77twvw.usnto. ov/ atentS/init events/
`
`
`
`iindex.‘s or send an inquiry to PPI-iieedback{®usgtc.00v.
`
`Application Papers
`
`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)|:l objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`
`Priority under 35 U.S.C. § 119
`
`12)I:| Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`
`a)I:l All
`
`b)|:l Some” c)I:l None of the:
`
`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
`
`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 (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)
`Paper No(s)/Mai| Date 10/29/2014 and 5/1/2015.
`
`US. Patent and Trademark Office
`PTOL—326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mai| Date 20150708
`
`

`

`Application/Control Number: 13/457,675
`
`Page 2
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`Art Unit: 1799
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`DETAILED ACTION
`
`Continued Examination Under 37 CFR 1.114
`
`A request for continued examination under 37 CFR 1.114, including the fee set forth in
`
`37 CFR l.l7(e), was filed in this application after final rejection. Since this application is
`
`eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR l.l7(e)
`
`has been timely paid, the finality of the previous Office action has been withdrawn pursuant to
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`37 CFR 1.114. Applicant's submission filed on 8/31/2015 has been entered.
`
`Response to Arguments
`
`Applicant's arguments filed 7/24/2015 have been fully considered but they are not
`
`persuasive.
`
`In response to applicant’s arguments that the Office Action is flawed at least in that the
`
`incubators of Herbert are characterized as both a "working chamber" and a "culture
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`chamber,
`
`the examiner disagrees. It is the position of the office that since incubator [21]
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`contains six discrete compartments [24] that house trays [52], the compartments [24] comprise a
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`separate housing which makes them discrete from one another, thereby providing two separate
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`elements, a working chamber (incubator) and a culture chamber (tray).
`
`In response to applicant’s arguments regarding openings configured to have a working
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`glove, Herbert teaches in at least paragraph 27 wherein isolation cabinets (working chamber)
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`contain openings [41, 42, 43, 44, 44, 45, 46 and 47] to which gloves are attached to allow objects
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`(culture apparatus, 52) inside the cabinet to be handled.
`
`

`

`Application/Control Number: 13/457,675
`
`Page 3
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`Art Unit: 1799
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`In view of the teaching above, which suggests that the culture apparatus may be mounted
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`in the isolation cabinet while being handled and then demounted once the analysis and/or
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`manipulation is complete it is the offices position that Herbert teaches wherein a working
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`chamber is capable of having a culture apparatus demountably mounted.
`
`In response to applicant’s arguments that “the cited art does not disclose or suggest
`
`such temperature adjustment in a working chamber or storage chamber. Further, the cited
`
`art does not disclose or suggest such adjustment after sealing of the working chamber or
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`storage chamber, and removal of the culture apparatus. ”,
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`the examiner respectfully
`
`disagrees.
`
`Szatmary discloses that it is known to provide isolation chambers with an aseptic or
`
`sterile environment to reduce contaminants in the air; in order for the experiments and the testing
`
`or manufacturing procedures to be effective; thereby reducing problems that may arise when
`
`items must be transferred from one chamber to another within a cell management device. It
`
`would have been obvious to one of ordinary skill in the art at the time the invention was made to
`
`modify Herbert with the environment controlling mechanism as taught by Barbera—Guillem in
`
`order to avoid a breach in maintenance of sterility of the cell culture environment.
`
`In response to applicant's argument that the cited art does not disclose or suggest such
`
`adjustment after sealing of the working chamber or storage chamber, and removal of the culture
`
`apparatus, a recitation of the intended use of the claimed invention must result in a structural
`
`difference between the claimed invention and the prior art in order to patentably distinguish the
`
`claimed invention from the prior art.
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`If the prior art structure is capable of performing the
`
`intended use, then it meets the claim.
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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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`Applicant’s arguments with respect to claim ll have been considered but are moot in
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`View of the current amendment.
`
`Claim Rejections - 35 USC § 112
`
`The following is a quotation of 35 USC. 112(b):
`(b) CONCLUSION.7The specification shall conclude with one or more claims particularly pointing
`out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the
`invention.
`
`The following is a quotation of 35 USC. 112 (pre—AIA), second paragraph:
`The specification shall conclude with one or more claims particularly pointing out and distinctly
`claiming the subject matter which the applicant regards as his invention.
`
`Claims 1—2, 4—5, 7—8 and 10—12 are rejected under 35 USC. 112(b) or 35 USC. 112
`
`(pre—AIA), second paragraph, as being indefinite for failing to particularly point out and
`
`distinctly claim the subject matter which the inventor or a joint inventor, or for pre—AIA the
`
`applicant regards as the invention.
`
`Regarding Claim 1 and 11, the examiner is unclear as to whether the culture apparatus is
`
`mounted to the on the outside of the working chamber or on the inside of the working chamber
`
`(e.g. a covered multiwall plate residing within the interior of the working chamber). As such, for
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`the purpose of examining, the examiner has interpreted the culture apparatus as being capable of
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`being mounted on either the outside or the inside of the working chamber.
`
`Furthermore, claim 1 teaches a first door and a third door without disclosing a second
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`door. There are a various doors and openings disclosed in the instant claim 1. However, it is
`
`unclear how the doors and opening correspond with one another.
`
`Moreover, it is unclear as to how these chamber are connected as they fail to disclose any
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`kind of connection means. As such, the chambers as disclosed may be interpreted as a series of
`
`

`

`Application/Control Number: 13/457,675
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`Page 5
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`Art Unit: 1799
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`containers/chambers that are sequentially housed in one another (e.g. an incubator unit which
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`comprises siX discrete compartments, wherein compartment houses sample container).
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`Claims 2, 4—5, 7—8 and 10 stands rejected as they depend on claim 1.
`
`Regarding claim 12, claim 12 teaches multiple chambers, however, it is unclear as to how
`
`these chamber are connected as they fail to disclose any kind of connection means. As such, the
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`chambers as disclosed may be interpreted as a series of containers/chambers that are sequentially
`
`housed in one another (e.g. an incubator unit which comprises siX discrete compartments,
`
`wherein compartment houses sample container).
`
`Furthermore, there are a various doors and openings disclosed in the instant claim 12.
`
`However, it is unclear how the doors and openings correspond with one another.
`
`Claim Rejections - 35 USC § 103
`
`The text of those sections of Title 35, US Code not included in this action can be found
`
`in a prior Office action.
`
`Claims 1-2, 4-5, 7-8, 10 and 12 are rejected under pre-AIA 35 U.S.C. 103(3) as being
`
`unpatentable over Herbert et al.
`
`(US 2010/0291664) in View of Barbera-Guillem (US
`
`20030040104) in light of Szatmary (US 6779567).
`
`Regarding Claim 1, Herbert et al.
`
`teaches an isolator capable of having a culture
`
`apparatus demountably mounted thereto, the isolator comprising:
`
`a working chamber [3, 6, 9,
`
`11, 13, 14 and 15]
`
`including a first opening (openings 41, 42, 43, 44, 44, 45, 46 and 47 to which
`
`

`

`Application/Control Number: 13/457,675
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`Page 6
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`Art Unit: 1799
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`gloves are attached to allow objects inside the cabinet to be handled; as discussed in paragraph
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`27) configured to allow a culture chamber (well) of the culture apparatus [52] and the working
`
`chamber to communicate with each other, when the culture apparatus has been mounted (see
`
`paragraphs 28 and 52); a storage chamber [2, 7, 29, 30, 32, 32, 33, 34, and 35]
`
`including a third
`
`door [26 or 28] configured to open or close a third opening, the third opening configured to allow
`
`the storage chamber and exterior to communicate with each other, the third door being a part of
`
`an outer surface of the isolator in a state where the third door is closed (see paragraph 29); a first
`
`door [49 or 51] configured to open or close a second opening, the second opening configured to
`
`allow the working chamber and the storage chamber to communicate with each (see paragraphs
`
`27—29 and 52—64; also see whole document).
`
`Herbert does not teach a temperature adjusting device.
`
`Barbera—Guillem teaches
`
`an automated cell management
`
`system comprising an
`
`environment controlling mechanism [16] which is provided with a temperature adjusting device
`
`(see paragraph 37; also see whole document).
`
`In view of the teachings of Szatmary who discloses that it is known to provide isolation
`
`chambers with an aseptic or sterile environment to reduce contaminants in the air; in order for
`
`the experiments and the testing or manufacturing procedures to be effective; thereby reducing
`
`problems that may arise when items must be transferred from one chamber to another within a
`
`cell management device. It would have been obvious to one of ordinary skill in the art at the time
`
`the invention was made to modify Herbert with the environment controlling mechanism as
`
`taught by Barbera—Guillem in order to avoid a breach in maintenance of sterility of the cell
`
`culture environment.
`
`

`

`Application/Control Number: 13/457,675
`
`Page 7
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`Art Unit: 1799
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`It is noted that neither the manner of operating a disclosed device nor material or article
`
`worked upon further limit an apparatus claim. Said limitations do not differentiate apparatus
`
`claims from prior art. See MPEP § 2114 and 2115. Further, it has been held that process
`
`limitations do not have patentable weight in an apparatus claim. See EX parte Thibault, 164
`
`USPQ 666, 667 (Ed. App. 1969) that states “Expressions relating the apparatus to contents
`
`thereof and to an intended operation are of no significance in determining patentability of the
`
`apparatus claim.”
`
`Regarding Claim 2 Herbert et al. teaches a second door configured to close the first
`
`opening when the culture apparatus is demounted (see paragraphs 52—56).
`
`Regarding Claims 4-5 Herbert et al.
`
`teaches a concentration adjusting device (see
`
`paragraph 27).
`
`With respect to the intended use limitations, the device disclosed by the combination of
`
`Herbert and Barbera—Guillem is structurally the same as the instantly claimed. Thus,
`
`in the
`
`absence of further positively recited structure the device of the combination of Herbert and
`
`Barbera—Guillem is capable of providing the operating conditions as listed in the intended use
`
`section of the claim.
`
`It is noted that neither the manner of operating a disclosed device nor material or article
`
`worked upon further limit an apparatus claim. Said limitations do not differentiate apparatus
`
`claims from prior art. See MPEP § 2114 and 2115. Further, it has been held that process
`
`limitations do not have patentable weight in an apparatus claim. See EX parte Thibault, 164
`
`

`

`Application/Control Number: 13/457,675
`
`Page 8
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`Art Unit: 1799
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`USPQ 666, 667 (Ed. App. 1969) that states “Expressions relating the apparatus to contents
`
`thereof and to an intended operation are of no significance in determining patentability of the
`
`apparatus claim.”
`
`Regarding Claims 7-8 and 10 Herbert et al. teaches a humidity adjusting device (see
`
`paragraph 28).
`
`With respect to the intended use limitations, the device disclosed by the combination of
`
`Herbert and Barbera—Guillem is structurally the same as the instantly claimed. Thus,
`
`in the
`
`absence of further positively recited structure the device of the combination of Herbert and
`
`Barbera—Guillem is capable of providing the operating conditions as listed in the intended use
`
`section of the claim.
`
`It is noted that neither the manner of operating a disclosed device nor material or article
`
`worked upon further limit an apparatus claim. Said limitations do not differentiate apparatus
`
`claims from prior art. See MPEP § 2114 and 2115. Further, it has been held that process
`
`limitations do not have patentable weight in an apparatus claim. See EX parte Thibault, 164
`
`USPQ 666, 667 (Ed. App. 1969) that states “Expressions relating the apparatus to contents
`
`thereof and to an intended operation are of no significance in determining patentability of the
`
`apparatus claim.”
`
`Regarding Claim 12 Herbert et al.
`
`teaches an isolator capable of having a culture
`
`apparatus demountably mounted thereto, the isolator comprising:
`
`a working chamber [3, 6, 9,
`
`11, 13, 14 and 15]
`
`including a first opening (openings 41, 42, 43, 44, 44, 45, 46 and 47 to which
`
`gloves are attached to allow objects inside the cabinet to be handled; as discussed in paragraph
`
`27) configured to allow a culture chamber (well) of the culture apparatus [52] and the working
`
`

`

`Application/Control Number: 13/457,675
`
`Page 9
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`Art Unit: 1799
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`chamber to communicate with each other, when the culture apparatus has been mounted (see
`
`paragraphs 28 and 52); a storage chamber [2, 7, 29, 30, 32, 32, 33, 34, and 35]
`
`including a third
`
`door [26 or 28] configured to open or close a third opening, the third opening configured to allow
`
`the storage chamber and exterior to communicate with each other, the third door being a part of
`
`an outer surface of the isolator in a state where the third door is closed (see paragraph 29); a first
`
`door [49 or 51] configured to open or close a second opening, the second opening configured to
`
`allow the working chamber and the storage chamber to communicate with each (see paragraphs
`
`27—29 and 52—64; also see whole document). In addition, Herbert teaches processes l—5 and 7
`
`(see paragraphs 27—28 and 47—64; also see whole document).
`
`Herbert does not teach a temperature adjusting device.
`
`Barbera—Guillem teaches
`
`an automated cell management
`
`system comprising an
`
`environment controlling mechanism [16] which is provided with a temperature adjusting device
`
`and a decontamination material (gas) supply (see paragraph 37; also see whole document).
`
`In view of the teachings of Szatmary who discloses that it is known to provide isolation
`
`chambers with an aseptic or sterile environment to reduce contaminants in the air; in order for
`
`the experiments and the testing or manufacturing procedures to be effective; thereby reducing
`
`problems that may arise when items must be transferred from one chamber to another within a
`
`cell management device. It would have been obvious to one of ordinary skill in the art at the time
`
`the invention was made to modify Herbert with the environment controlling mechanism as
`
`taught by Barbera—Guillem in order to avoid a breach in maintenance of sterility of the cell
`
`culture environment.
`
`

`

`Application/Control Number: 13/457,675
`
`Page 10
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`Art Unit: 1799
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`Therefore, Herbert as modified by Barbera—Guillem and Szatmary, results in the claimed
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`isolator being configured in the claimed manner thus, the process steps will necessary follow.
`
`Claim 11 is rejected under pre-AIA 35 U.S.C. 103(3) as being unpatentable over
`
`Polsky (US 2011/0126498)
`
`in View of Barbera-Guillem (US 20030040104)
`
`in light of
`
`Szatmary (US 6779567).
`
`Regarding Claim ll, Polsky teaches an isolator [10] comprising: a working chamber [16]
`
`which is capable of having a culture apparatus [106] demountably mounted thereto (see
`
`paragraphs 48; FIG. 3), and including an opening configured to attach a working glove thereto
`
`(see FIGS. 1A and 10) and a first opening configured to be attached a working glove for working
`
`in the working chamber (see FIGS. 1A and 10), and a second opening [32] configured to allow a
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`culture chamber (components of canister 106; paragraph 48) of the culture apparatus and the
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`working chamber to communicate with each other, when the culture apparatus has been
`
`mounted, wherein a culture is not cultured in the working chamber; a door [98] configured to
`
`close the second opening so as to hermetically seal the working chamber.
`
`Polsky does not explicitly disclose a temperature adjusting device however, he does
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`disclose that a heating means is provided in flange [96] which is use to conduct heat sterilization
`
`(see paragraph 48).
`
`Barbera—Guillem teaches
`
`an automated cell management
`
`system comprising an
`
`environment controlling mechanism [16] which is provided with a temperature adjusting device
`
`(see paragraph 37; also see whole document).
`
`

`

`Application/Control Number: 13/457,675
`
`Page 11
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`Art Unit: 1799
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`In view of the teachings of Szatmary who discloses that it is known to provide isolation
`
`chambers with an aseptic or sterile environment to reduce contaminants in the air; in order for
`
`the experiments and the testing or manufacturing procedures to be effective; thereby reducing
`
`problems that may arise when items must be transferred from one chamber to another within a
`
`cell management device. It would have been obvious to one of ordinary skill in the art at the time
`
`the invention was made to modify the working chamber of Polsky with the environment
`
`controlling mechanism as taught by Barbera—Guillem in order to avoid a breach in maintenance
`
`of sterility of the cell culture environment.
`
`It is noted that neither the manner of operating a disclosed device nor material or article
`
`worked upon further limit an apparatus claim. Said limitations do not differentiate apparatus
`
`claims from prior art. See MPEP § 2114 and 2115. Further, it has been held that process
`
`limitations do not have patentable weight in an apparatus claim. See Ex parte Thibault, 164
`
`USPQ 666, 667 (Ed. App. 1969) that states “Expressions relating the apparatus to contents
`
`thereof and to an intended operation are of no significance in determining patentability of the
`
`apparatus claim.”
`
`Conclusion
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to LYDIA EDWARDS whose telephone number is (571)270—3242.
`
`The examiner can normally be reached on Mon—Thur 6:30—5:00.
`
`

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`Application/Control Number: 13/457,675
`
`Page 12
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`Art Unit: 1799
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`If attempts to reach the examiner by telephone are unsuccessful,
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`the examiner’s
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`supervisor, Michael Marcheschi can be reached on 571.272.1374. The fax phone number for the
`
`organization Where this application or proceeding is assigned is 571—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 USPTO Customer Service Representative or access to the automated
`
`information system, call 800—786—9199 (IN USA OR CANADA) or 571—272—1000.
`
`/LYDIA EDWARDS/
`
`Examiner
`
`Art Unit 1799
`
`/LYLE ALEXANDER/
`
`Supervisory Patent Examiner, Art Unit
`1797
`
`LE
`
`