`
`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
`
`03/02/2015 —WESTERMAN, HATTORI, DANIELS & ADRIAN, LLP m
`7590
`38834
`1250 CONNECTICUT AVENUE, NW
`EDWARDS’ LYDIAE
`SUITE 700
`WASHINGTON, DC 20036
`
`PAPER NUMBER
`
`1775
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`03/02/2015
`
`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
`
`1775LYDIA EDWARDS its“
`
`-- 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 7/24/2014.
`El A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`2b)|:l This action is non-final.
`2a)|Z| 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
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`; 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) 12 4-5 7-83nd10- 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 z/thvvvtlsnto. ovI’ atentS/init events/
`
`
`
`hI/index.‘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) D 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
`
`Part of Paper No./Mai| Date 20141103
`
`

`

`Application/Control Number: 13/457,675
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`Page 2
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`Art Unit: 1775
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`DETAILED ACTION
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`Response to Arguments
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`Applicant's arguments filed 7/24/2014 have been fully considered but they are not
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`persuasive.
`
`In response to applicants arguments that “Applicants respectfully submit that the
`
`"temperature adjusting device configured to... adjust temperature of the culture stored in
`
`the storage chamber" of claim 1 is not disclosed or suggested, even if Herbert and Barbera-
`
`Guillem are combined. Additionally, the combination of cited art also fails to disclose or
`
`suggest a "third door" which is a part of an outer surface of the isolator when the door is
`
`closed. Therefore, Applicants respectfully submit that claim 1 and all claims dependent
`
`thereon are not obvious in View of the cited art. ”, 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
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`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.
`
`Furthermore, as interpreted by the examiner, Herbert discloses a third door [2, 7, 29, 30,
`
`32, 32, 33, 34, and 35] 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).
`
`

`

`Application/Control Number: 13/457,675
`
`Page 3
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`Art Unit: 1775
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`In response to applicants arguments regarding claim 12, as interpreted by the examiner,
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`Herbert teaches wherein the culture apparatus [52] is demountably mounted on tray [52] (see
`
`paragraph 28). Thus, the culture taken out of the first compartment [24] can be put into the
`
`second compartment [24]. Therefore, Herbert meets the claim.
`
`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.
`
`Claim 12 is
`
`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
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`matter which the inventor or a joint inventor, or for pre—AIA the applicant regards as the
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`invention.
`
`Claim 12 discloses “through the second opening and the first opening in order” however,
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`it is unclear as to what is meant by “in order”.
`
`Is the movement to be performed in a preferred
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`order? Is the movement through the first opening to precede the movement through the second
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`opening or is the movement through the second opening to precede the movement through the
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`first opening?
`
`For the purpose of examining, the examiner has interpreted claim 12 as requiring that the
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`culture be moved through both the first and second opening in no particular order.
`
`

`

`Application/Control Number: 13/457,675
`
`Page 4
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`Art Unit: 1775
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`Claim Rejections - 35 USC § 103
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`The following is a quotation of pre—AIA 35 USC. 103(a) which forms the basis for all
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`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 C0., 383 US. l, 148 USPQ 459
`
`(1966), that are applied for establishing a background for determining obviousness under pre—
`
`AIA 35 USC. 103(a) are summarized as follows:
`
`1. Determining the scope and contents of the prior art.
`
`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 obviousness or
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`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 USC. 103(a), the examiner presumes that the subject matter of the
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`various claims was commonly owned at the time any inventions covered therein were made
`
`absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to
`
`

`

`Application/Control Number: 13/457,675
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`Page 5
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`Art Unit: 1775
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`point out the inventor and invention dates of each claim that was not commonly owned at the
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`time a later invention was made in order for the examiner to consider the applicability of pre—
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`AIA 35 U.S.C. 103(c) and potential pre—AIA 35 U.S.C. lO2(e), (f) or (g) prior art under pre—AIA
`
`35 U.S.C. 103(a).
`
`Claims 1-2, 4-5, 7-8 and 10-12 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.
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`teaches an isolator capable of having a culture
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`apparatus demountably mounted thereto, the isolator comprising: a working chamber [5, 8, 10,
`
`12, 37 and 38] including a first opening [25 or 50] configured to allow a culture chamber [24] of
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`the culture apparatus [52] and the working chamber to communicate with each other, when the
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`culture apparatus has been mounted (see paragraphs 28 and 52); a storage chamber [3, 6, 9, ll,
`
`l3, l4 and 15] including a third door [2, 7, 29, 30, 32, 32, 33, 34, and 35] 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—28 and 52—64; also see whole
`
`document).
`
`Herbert does not teach a temperature adjusting device.
`
`

`

`Application/Control Number: 13/457,675
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`Page 6
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`Art Unit: 1775
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`Barbera—Guillem teaches
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`an automated cell management
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`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.
`
`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).
`
`

`

`Application/Control Number: 13/457,675
`
`Page 7
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`Art Unit: 1775
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`Regarding Claims 4-5 Herbert et al.
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`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
`
`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 patentabi1ity 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.
`
`

`

`Application/Control Number: 13/457,675
`
`Page 8
`
`Art Unit: 1775
`
`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 11 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 configured to be attached a working glove [41, 42, 43,
`
`44, 45, 46, 47] for working in the working chamber (see paragraph 27), and a second opening
`
`[25 or 50] configured to allow a culture chamber of the culture apparatus and the working
`
`chamber to communicate with each other, when the culture apparatus has been mounted; a door
`
`[49] configured to close the second opening so as to hermetically seal the working chamber.
`
`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
`
`

`

`Application/Control Number: 13/457,675
`
`Page 9
`
`Art Unit: 1775
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`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.
`
`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 [5, 8, 10,
`
`12, 37 and 38] including a first opening [25 or 50] configured to allow a culture chamber [24] 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 [3, 6, 9, 11,
`
`13, 14 and 15] including a third door [2, 7, 29, 30, 32, 32, 33, 34, and 35] 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
`
`

`

`Application/Control Number: 13/457,675
`
`Page 10
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`Art Unit: 1775
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`storage chamber to communicate with each. In addition, Herbert teaches processes 1—5 and 7 (see
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`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.
`
`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.”
`
`

`

`Application/Control Number: 13/457,675
`
`Page 11
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`Art Unit: 1775
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`Conclusion
`
`THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time
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`policy as set forth in 37 CFR l.l36(a).
`
`A shortened statutory period for reply to this final action is set
`
`to expire THREE
`
`MONTHS from the mailing date of this action.
`
`In the event a first reply is filed Within TWO
`
`MONTHS of the mailing date of this final action and the advisory action is not mailed until after
`
`the end of the THREE—MONTH shortened statutory period, then the shortened statutory period
`
`Will expire on the date the advisory action is mailed, and any extension fee pursuant to 37
`
`CFR l.l36(a) Will be calculated from the mailing date of the advisory action.
`
`In no event,
`
`however, Will the statutory period for reply expire later than SIX MONTHS from the mailing
`
`date of this final action.
`
`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.
`
`If attempts to reach the examiner by telephone are unsuccessful,
`
`the examiner’s
`
`supervisor, Michael Marcheschi can be reached on 571.272.1374. The fax phone number for the
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`organization Where this application or proceeding is assigned is 571—273—8300.
`
`

`

`Application/Control Number: 13/457,675
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`Page 12
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`Art Unit: 1775
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`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
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`system, see http://pair—direct.uspto. gov. Should you have questions on access to the Private PAIR
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`system, contact the Electronic Business Center (EBC) at 866—217—9197 (toll—free). If you would
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`information system, call 800—786—9199 (IN USA OR CANADA) or 571—272—1000.
`
`/NATHAN BOWERS/
`
`/LYDIA EDWARDS/
`
`Primary Examiner, Art Unit 1775
`
`Examiner
`
`Art Unit 1775
`
`LE
`
`