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`F ING OR 371 (C) DATE
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`APPLICATION NUMBER
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`FIRST NAMED APPLICANT
`
`ATTY. DOCKET NO./TITLE
`
`14/493,903
`
`09/23/2014
`
`Shirou SAWA
`
`2014-1250
`CONFIRMATION NO. 7395
`
`513
`
`WENDEROTH, LIND & PONACK, L.L.P.
`1030 15th Street, N.W.,
`Suite 400 East
`
`Washington, DC 20005-1503
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`PUBLICATION NOTICE
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`IIIIIIIIIIIIIIIIIIIIIIIIILIIIII
`
`
`
`IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIILOOOOO
`
`Title:AQUEOUS LIQUID PREPARATION CONTAINING 2-AMINO-3-(4-BROMOBENZOYL)PHENYLACETIC
`ACID
`
`Publication No.US-2015-0011634-A1
`Publication Date:01/08/2015
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`page 1 of 1
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`Page 1 of 366
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`LUPIN EX 1048
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`LUPIN EX 1048
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`Page 1 of 366
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`UNITED STATES DEPARTMENT OF COMMERCE
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`Address: COMIVHSSIONER FOR PATENTS
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`APPLICATION NO.
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`14/493,903
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`ISSUE DATE
`
`01/06/2015
`
`PATENT NO.
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`8927606
`
`2014—1250
`
`7395
`
`513
`
`7590
`
`12/17/2014
`
`WENDEROTH, LIND & PONACK, L.L.P.
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`ISSUE NOTIFICATION
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`Determination of Patent Term Adjustment under 35 U.S.C. 154 (b)
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`APPLICANT(S) (Please see PAIR WEB site http://pair.uspto. gov for additional applicants):
`
`Shirou SAWA, Hyogo, JAPAN;
`SENJU PHARMACEUTICAL CO., LTD., Osaka, JAPAN, Assignee (with 37 CFR 1.172 Interest);
`Shuhei FUJITA, Hyogo, JAPAN;
`
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`IR103 (1239119303) Of 366
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`Page 2 of 366
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`Page 3 of 366
`
`
`
`Electronic Patent Application Fee Transmittal
`
`Filing Date:
`
`23-Sep-2014
`
`T'tle °f Inventwn‘
`
`AQUEOUS LIQUID PREPARATION CONTAINING 2-AMINO-3-(4-
`BROMOBENZOYL)PHENYLACETIC ACID
`
`Utility under 35 USC111(a) Filing Fees
`
`Description
`
`Fee Code
`
`Quantity
`
`Sub-Total in
`
`USD($)
`
`_—
`
`
`
`Basic Filing:
`
`Miscellaneous Filing:
`
`Patent Appeals and-Interference:
`
`Post-Al|owance-and-Post-lssuance:
`
`Extensarééofi-yrggé
`
`Page 4 of 366
`
`
`
`Miscellaneous:
`
`Total in USD (5)
`
`Page 5 of 366
`
`Page 5 of 366
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`
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`T'tle °f Inventwn‘
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`AQUEOUS LIQUID PREPARATION CONTAINING 2-AMINO-3-(4-
`BROMOBENZOYL)PHENYLACETIC ACID
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`Electronic Acknowledgement Receipt
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`——
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`Payment information:
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`Submitted with Payment
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`Payment Type
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`RAM confirmation Number
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`Authorized User
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`yes
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`555
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`CHEEKJR., WARREN M.
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`figg'ggagmgditional Fees required under 37 C.F.R. Section 1.17 (Patent application and reexamination processing fees)
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`The Director of the USPTO is hereby authorized to charge indicated fees and credit any overpayment as follows:
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`Charge any Additional Fees required under 37 C.F.R. Section 1.16 (National application filing, search, and examination fees)
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`Issue Fee Payment (PTO-85B)
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`AttachA_IF.pdf
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`415516
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`c2d1
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`The PDF file has been signed with a digital signature and the legal effect of the document will be based on the contents of the file not the
`digital signature.
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`Fee Worksheet (SB06)
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`fee-info.pdf
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`1363e483d9503e897c14300d4941ebc9a13
`9c76f
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`This Acknowledgement Receipt evidences receipt on the noted date by the USPTO ofthe indicated documents,
`characterized by the applicant, and including page counts, where applicable. It serves as evidence of receipt similar to a
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`New Applications Under 35 U.S.C. 111
`lfa new application is being filed and the application includes the necessary components for a filing date (see 37 CFR
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria1 Virginia 22313-1450
`www.uspto.gov
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`NOTICE OF ALLOWANCE AND FEE(S) DUE
`
`513
`
`7590
`
`11/19/2014
`
`WENDEROTH, LIND & PONACK, L.L.P.
`1030 15th Street, N.W.,
`5.1.400];
`
`Washington, DC 20005-1503
`
`
`
`
`
`SOROUSH,LAYLA
`
`1627
`
`DATE MAILED: 11/19/2014
`
`14/493,903
`
`09/23/2014
`
`Shirou SAWA
`
`2014—1250
`
`7395
`
`TITLE OF INVENTION: AQUEOUS LIQUID PREPARATION CONTAINING 2—AMINO—3—(4—BROMOBENZOYL)PHENYLACETIC ACID
`
`APPLN. TYPE
`
`ENTITY STATUS
`
`ISSUE FEE DUE
`
`PUBLICATION FEE DUE
`
`PREV. PAID ISSUE FEE
`
`TOTAL FEE(S) DUE
`
`DATE DUE
`
`nonprovisional
`
`UNDISCOUNTED
`
`$960
`
`$0
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`$0
`
`$960
`
`02/ 1 9/201 5
`
`THE APPLICATION IDENTIFIED ABOVE HAS BEEN EXAMINED AND IS ALLOWED FOR ISSUANCE AS A PATENT.
`PROSECUTION ON THE MERITS IS CLOSED. THIS NOTICE OF ALLOWANCE IS NOT A GRANT OF PATENT RIGHTS.
`THIS APPLICATION IS SUBJECT TO WITHDRAWAL FROM ISSUE AT THE INITIATIVE OF THE OFFICE OR UPON
`PETITION BY THE APPLICANT. SEE 37 CFR 1.313 AND MPEP 1308.
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`THE ISSUE FEE AND PUBLICATION FEE (IF REQUIRED) MUST BE PAID WITHIN THREE MONTHS FROM THE
`MAILING DATE OF THIS NOTICE OR THIS APPLICATION SHALL BE REGARDED AS ABANDONED.
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`SEE 35 U.S.C. 151. THE ISSUE FEE DUE INDICATED ABOVE DOES
`NOT REFLECT A CREDIT FOR ANY PREVIOUSLY PAID ISSUE FEE IN THIS APPLICATION.
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`II. PART B - FEE(S) TRANSMITTAL, or its equivalent, must be completed and returned to the United States Patent and Trademark Office
`(USPTO) with your ISSUE FEE and PUBLICATION FEE (if required). If you are charging the fee(s) to your deposit account, section "4b"
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`IMPORTANT REMINDER: Utility patents issuing on applications filed on or after Dec. 12, 1980 may require payment of
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`PTOL—85 (Rev. 02/11)
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`Page 1 0f 3
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`Page 8 of 366
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`PART B - FEE(S) TRANSMITTAL
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`Complete and send this form, together with applicable fee(s), to: Mail Mail Stop ISSUE FEE
`Commissioner for Patents
`PO. Box 1450
`Alexandria, Virginia 22313-1450
`or m (571)-273-2885
`
`through 5 should be completed where
`INSTRUCTIONS: This form should be used for transmitting the ISSUE FEE and PUBLICATION FEE (if required). Blocks 1
`péJropriate. All further correspondence including the Patent, advance orders and notification of maintenance fees will be mailed to the current correspondence address as
`n icated unless corrected below or directed otherwise in Block 1, by (a) specifying a new correspondence address; and/or (b) indicating a separate "FEE ADDRESS" for
`maintenance fee notifications.
`
`a i
`
`CURRENT CORRESPONDENCE ADDRESS (Note: Use Block 1 for any change ofaddFESS)
`
`11/19/2014
`7590
`513
`WENDEROTH, LIND & PONACK, L...LP
`1030 15th St
`t N W
`.
`1‘66 ’
`'
`Su1te 400 East
`
`"
`
`Washlngton, DC 20005-1503
`
`Note: A certificate of mailin can only be used for domestic mailings of the
`Fee(s) Transmittal. This certi icate cannot be used for any other accompanying
`fiapers. Each additional paper, such as an assignment or formal drawing, must
`ave its own certificate of mailing or transmission.
`
`Certificate of Mailing or Transmission
`I hereby certify that this Fee(s) Transmittal is being deposited with the United
`States Postal Service with sufficient postage for first class mail in an envelope
`addressed to the Mail Stop ISSUE FEE address above, or being facsimile
`transmitted to the USPTO (571) 273—2885, on the date indicated below.
`
`(Date)
`
`(Depositorsname)
`(Signature)
`
`APPLICATION NO.
`
`FILING DATE
`
`
`
`
` F {ST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`14/493,903
`
`09/23/2014
`
`Shirou SAWA
`
`2014— 1250
`
`7395
`
`TITLE OF INVENTION: AQUEOUS LIQUID PREPARATION CONTAINING 2—AMINO—3—(4—BROMOBENZOYL)PHENYLACETIC ACID
`
`APPLN. TYPE
`
`ENTITY STATUS
`
`ISSUE FEE DUE
`
`PUBLICATION FEE DUE
`
`PREV. PAID ISSUE FEE
`
`TOTAL FEE(S) DUE
`
`DATE DUE
`
`nonprovisional
`
`UNDISCOUNTED
`
`$960
`
`$0
`
`$0
`
`$960
`
`02/ 1 9/201 5
`
`EXAMINER
`
`ART UNIT
`
`CLASS-SUB CLASS
`
`SOROUSH, LAYLA
`
`1627
`
`514—619000
`
`1. Change of correspondence address or indication of "Fee Address" (37
`CFR 1.363).
`
`3 Chan e of correspondence address (or Change of Correspondence
`Address orm PTO/SB/ 122) attached.
`
`
`
`
`
`2
`
`3
`
`3 "Fee Address" indication (or "Fee Address" Indication form
`PTO/SB/47; Rev 03—02 or more recent) attached. Use of a Customer
`Vumber is required.
`3. ASSIGNEE NAME AND RESIDENCE DATA TO BE PRINTED ON THE PATENT (print or type)
`If an assignee is identified below, the document has been filed for
`PLEASE NOTE: Unless an assignee is identified below, no assignee data will appear on the patent.
`recordation as set forth in 37 CFR 3.11. Completion of this form is NOT a substitute for filing an assignment.
`(A) NAME OF ASSIGNEE
`(B) RESIDENCE: (CITY and STATE OR COUNTRY)
`
`2. For printing on the patent front page, list
`(1) The names of up to 3 registered patent attorneys
`1
`or agents OR, alternatively,
`(2) The name of a single firm (having as a member a
`registered attorney or agent) and the names of up to
`2 registered patent attorneys or agents. If no name is
`listed, no name will be printed.
`
`
`
`Please check the appropriate assignee category or categories (will not be printed on the patent) :
`
`'3 Individual
`
`'3 Corporation or other private group entity '3 Government
`
`4a. The following fee(s) are submitted:
`3 Issue Fee
`
`
`
`3 Publication Fee (No small entity discount permitted)
`3 Advance Order — # of Copies
`
`4b. Payment of Fee(s): (Please first reapply any previously paid issue fee shown above)
`3 A check is enclosed.
`
`3 Payment by credit card. Form PTO—2038 is attached.
`3 The director is hereby authorized to charge the required fee(s), any deficiency, or credits any
`overpayment, to Deposit Account Number
`(enclose an extra copy of this form).
`
`
`
`5. Change in Entity Status (from status indicated above)
`3 Applicant certifying micro entity status. See 37 CFR 1.29
`
`3 Applicant asserting small entity status. See 37 CFR 1.27
`
` 3 Applicant changing to regular undiscounted fee status.
`
`NOTE: Absent a valid certification of Micro Entity Status (see forms PTO/SB/ 15A and 15B), issue
`fee payment in the micro entity amount will not be accepted at the risk of application abandonment.
`NOTE: If the application was previously under micro entity status, checking this box will be taken
`to be a notification of loss of entitlement to micro entity status.
`NOTE: Checking this box will be taken to be a notification of loss of entitlement to small or micro
`entity status, as applicable.
`
`NOTE: This form must be signed in accordance with 37 CFR 1.31 and 1.33. See 37 CFR 1.4 for signature requirements and certifications.
`
`Authorized Signature
`
`Typed or printed name
`
`
`Date
`
`Registration No.
`
`Page 9 of 366
`
`Page 2 of 3
`
`PTOL—85 Part B (10—13) Approved for use through 10/31/2013.
`
`OMB 0651—0033
`
`US. Patent and Trademark Office; US. DEPARTMENT OF COMMERCE
`
`Page 9 of 366
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`APPLICATION NO.
`
`FILING DATE
`
`
`
`
`F {ST NAMED INVENTOR
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria1 Virginia 22313-1450
`www.uspto.gov
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`14/493,903
`
`09/23/2014
`
`Shirou SAWA
`
`2014—1250
`
`7395
`
`513
`
`7590
`
`11/19/2014
`
`WENDEROTH, LIND & PONACK, L.L.P.
`1030 15th Street, N.W.,
`5.1640013...
`
`Washington, DC 20005-1503
`
`SOROUSH,LAYLA
`
`1627
`
`DATE MAILED: 11/19/2014
`
`Determination of Patent Term Adjustment under 35 U.S.C. 154 (b)
`
`(Applications filed on or after May 29, 2000)
`
`The Office has discontinued providing a Patent Term Adjustment (PTA) calculation with the Notice of Allowance.
`
`to eliminate the
`Section 1(h)(2) of the AIA Technical Corrections Act amended 35 U.S.C. 154(b)(3)(B)(i)
`requirement that the Office provide a patent term adjustment determination with the notice of allowance. See
`Revisions to Patent Term Adjustment, 78 Fed. Reg. 19416, 19417 (Apr. 1, 2013). Therefore, the Office is no longer
`providing an initial patent term adjustment determination with the notice of allowance. The Office will continue to
`provide a patent term adjustment determination with the Issue Notification Letter that is mailed to applicant
`approximately three weeks prior to the issue date of the patent, and will include the patent term adjustment on the
`patent. Any request for reconsideration of the patent term adjustment determination (or reinstatement of patent term
`adjustment) should follow the process outlined in 37 CFR 1.705.
`
`Any questions regarding the Patent Term Extension or Adjustment determination should be directed to the Office of
`Patent Legal Administration at (571)—272—7702. Questions relating to issue and publication fee payments should be
`directed to the Customer Service Center of the Office of Patent Publication at 1—(888)—786—0101 or (571)—272—4200.
`
`Page 10 of 366
`PTOL—85 (Rev. 02/11)
`
`Page 3 0f 3
`
`Page 10 of 366
`
`
`
`OMB Clearance and PRA Burden Statement for PTOL-85 Part B
`
`The Paperwork Reduction Act (PRA) of 1995 requires Federal agencies to obtain Office of Management and
`Budget approval before requesting most types of information from the public. When OMB approves an agency
`request to collect information from the public, OMB (i) provides a valid OMB Control Number and expiration
`date for the agency to display on the instrument that will be used to collect the information and (ii) requires the
`agency to inform the public about the OMB Control Number’s legal significance in accordance with 5 CFR
`1320.5(b).
`
`The information collected by PTOL-85 Part B is required by 37 CFR 1.311. The information is required to obtain
`or retain a benefit by the public which is to file (and by the USPTO to process) an application. Confidentiality is
`governed by 35 U.S.C. 122 and 37 CFR 1.14. This collection is estimated to take 12 minutes to complete,
`including gathering, preparing, and submitting the completed application form to the USPTO. Time will vary
`depending upon the individual case. Any comments on the amount of time you require to complete this form
`and/or suggestions for reducing this burden, should be sent to the Chief Information Officer, U.S. Patent and
`Trademark Office, U.S. Department of Commerce, PO. Box 1450, Alexandria, Virginia 22313-1450. DO NOT
`SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, PO. Box
`1450, Alexandria, Virginia 22313-1450. Under the Paperwork Reduction Act of 1995, no persons are required to
`respond to a collection of information unless it displays a valid OMB control number.
`
`Privacy Act Statement
`
`The Privacy Act of 1974 (PL. 93-579) requires that you be given certain information in connection with your
`submission of the attached form related to a patent application or patent. Accordingly, pursuant
`to the
`requirements of the Act, please be advised that: (1) the general authority for the collection of this information is
`35 U.S.C. 2(b)(2); (2) furnishing of the information solicited is voluntary; and (3) the principal purpose for which
`the information is used by the U.S. Patent and Trademark Office is to process and/or examine your submission
`related to a patent application or patent. If you do not furnish the requested information, the U.S. Patent and
`Trademark Office may not be able to process and/or examine your submission, which may result in termination of
`proceedings or abandonment of the application or expiration of the patent.
`
`The information provided by you in this form will be subject to the following routine uses:
`1. The information on this form will be treated confidentially to the extent allowed under the Freedom of
`Information Act (5 U.S.C. 552) and the Privacy Act (5 U.S.C 552a). Records from this system of records
`may be disclosed to the Department of Justice to determine whether disclosure of these records is required
`by the Freedom of Information Act.
`2. A record from this system of records may be disclosed, as a routine use, in the course of presenting evidence
`to a court, magistrate, or administrative tribunal, including disclosures to opposing counsel in the course of
`settlement negotiations.
`3. A record in this system of records may be disclosed, as a routine use, to a Member of Congress submitting a
`request involving an individual, to whom the record pertains, when the individual has requested assistance
`from the Member with respect to the subject matter of the record.
`4. A record in this system of records may be disclosed, as a routine use, to a contractor of the Agency having
`need for the information in order to perform a contract. Recipients of information shall be required to
`comply with the requirements of the Privacy Act of 1974, as amended, pursuant to 5 U.S.C. 552a(m).
`5. A record related to an International Application filed under the Patent Cooperation Treaty in this system of
`records may be disclosed, as a routine use, to the International Bureau of the World Intellectual Property
`Organization, pursuant to the Patent Cooperation Treaty.
`6. A record in this system of records may be disclosed, as a routine use, to another federal agency for purposes
`of National Security review (35 U.S.C. 181) and for review pursuant to the Atomic Energy Act (42 U.S.C.
`218(c)).
`7. A record from this system of records may be disclosed, as a routine use, to the Administrator, General
`Services, or his/her designee, during an inspection of records conducted by GSA as part of that agency's
`responsibility to recommend improvements in records management practices and programs, under authority
`of 44 U.S.C. 2904 and 2906. Such disclosure shall be made in accordance with the GSA regulations
`governing inspection of records for this purpose, and any other relevant (i.e., GSA or Commerce) directive.
`Such disclosure shall not be used to make determinations about individuals.
`
`8. A record from this system of records may be disclosed, as a routine use, to the public after either publication
`of the application pursuant to 35 U.S.C. 122(b) or issuance of a patent pursuant to 35 U.S.C. 151. Further, a
`record may be disclosed, subject to the limitations of 37 CFR 1.14, as a routine use, to the public if the
`record was filed in an application which became abandoned or in which the proceedings were terminated
`and which application is referenced by either a published application, an application open to public
`inspection or an issued patent.
`9. A record from this system of records may be disclosed, as a routine use, to a Federal, State, or local law
`Page equrcfé‘gent agency, if the USPTO becomes aware of a violation or potential violation of law or regulation.
`
`Page 11 of 366
`
`
`
`
`
`Notice of Allowability
`
`Application No.
`
`14/493,903
`Examiner
`
`Applicant(s)
`
`SAWA ET AL.
`Art Unit
`
`LAYLA SOROUSH
`
`1627
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address--
`All claims being allowable, PROSECUTION ON THE MERITS IS (OR REMAINS) CLOSED in this application.
`If not included
`herewith (or previously mailed), a Notice of Allowance (PTOL-85) or other appropriate communication will be mailed in due course. THIS
`NOTICE OF ALLOWABILITY IS NOT A GRANT OF PATENT RIGHTS. This application is subject to withdrawal from issue at the initiative
`of the Office or upon petition by the applicant. See 37 CFR 1.313 and MPEP 1308.
`
`1. IX This communication is responsive to the TD filed on 11/5/14l 11/06/14 and approved on 11/6/14 and 11/7/14.
`
`2. I] An election was made by the applicant in response to a restriction requirement set forth during the interview on
`requirement and election have been incorporated into this action.
`
`; the restriction
`
`3. IZI The allowed claim(s) is/are 19-48.
`
`4. IX Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119( )-(d) or (f).
`
`a) IX All
`
`b) [I Some*
`
`c) [I None
`
`of the:
`
`1. El Certified copies of the priority documents have been received.
`
`.
`
`2. IX Certified copies of the priority documents have been received in Application No. 10/525,006.
`
`3. El 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( )).
`
`* Certified copies not received:
`
`Applicant has THREE MONTHS FROM THE “MAILING DATE” of this communication to file a reply complying with t