ASSIGNMENT
`
`As a below named inventor, I hereby declare that:
`the equivalent
`IN CONSIDERATION of
`the
`sum of one Dollar{$1.00) or
`thereof, and other good and valuable consideration paid to me citizen of Japan
`by OTSUKA PHARMACEUTICAL CO., LTD., a corpora ti on organized under the laws of
`Japan,
`located at 2-9, Kanda-Tsukasacho, chiyoda-ku, Tokyo, Japan, receipt of
`which
`is hereby acknowledged
`I do hereby sell and assign
`to said OTSUKA
`PHARMACEUTICAL co., LTD., its successors and assigns, all my right, title and
`interest, in and for the United States of America, in and to
`
`CARBOSTYRIL DERIVATIVES AND MOOD STABILIZERS FOR TREATING MOOD DISORDERS
`
`invented by me (if only one is named below) or us (if plural inventors are
`named below) and described in the application for United States Letters Patent
`therefor, executed on even date herewith,
`
`and all United States Letters Patent which may be granted therefor, and all
`divisions, continuations and extensions thereof,
`the said interest being the
`entire ownership of
`the said Letters Patent when granted,
`to be held and
`its successors, assigns or
`enjoyed by said OTSUKA PHARMACEUTICAL CO., LTD. 1
`other legal representatives, to the full end of term for which said Letters
`?atent may be granted, as fully and entirely as the same would have been held
`and enjoyed by me or us if this assignment and sale had not been made;
`
`I hereby agree to sign and execute any further documents or
`And
`instruments which may be necessary, lawful, and proper in the prosecution of
`the above-named application or in the preparation and prosecution of any
`continuing, continuation-in-part, substitute, divisional, renewal, reviewed or
`reissue applications or in any amendment, extension, or interference
`proceedings, or otherwise to secure the title thereto in said assignee;
`
`And I do hereby authorize and request the commissioner of Patents to
`issue said Letters Patent to said OTSUKA PHARMACEUTICAL CO., LTD.
`
`Signed on the date(s)
`INVENTOR(S)
`
`indicated aside signatures:
`Date Signed
`
`(:@lffl~7 )J,;f.-L.-lt-1 /)
`
`(~~8)
`
`WITNESSES
`(.1Z.~f-if1 /)
`
`October 7, 2005
`
`September 30, 2005~_..._.J~~~~~,U~h~~=='-"'""'--~~-
`
`1 )
`
`2)
`
`3)
`
`4)
`
`5)
`
`6)
`
`7)
`
`8)
`
`9)
`
`901 of 1328
`
`Alkermes, Ex. 1076
`
`

`
`Electronic Acknowledgement Receipt
`
`EFSID:
`
`Application Number:
`
`1966133
`
`10556600
`
`International Application Number:
`
`Confirmation Number:
`
`3822
`
`Title of Invention:
`
`Carbostyril derivatives and mood stabilizers for treating mood disorders
`
`First Named Inventor/Applicant Name:
`
`Tetsuro Kikuchi
`
`Customer Number:
`
`23373
`
`Filer:
`
`Bruce Elliot Kramer/Laurin Smith
`
`Filer Authorized By:
`
`Bruce Elliot Kramer
`
`Attorney Docket Number:
`
`081665
`
`Receipt Date:
`
`Filing Date:
`
`Time Stamp:
`
`12-JUL-2007
`
`02-AUG-2006
`
`15:45:48
`
`Application Type:
`
`U.S. National Stage under 35 USC 371
`
`Payment information:
`
`Submitted with Payment
`
`no
`
`File Listing:
`
`Document
`Number
`
`Document Description
`
`File Name
`
`Pages
`Multi
`File Size(Bytes)
`/Message Digest Part /.zip (if appl.}
`
`228325
`
`1
`
`Request for Corrected Filing Receipt
`
`OFRCORRECTION.pdf
`
`no
`
`5
`
`7038e4057f1 875a067a9eb601aa58174
`d43f850e
`
`Warnings:
`
`902 of 1328
`
`Alkermes, Ex. 1076
`
`

`
`Information:
`
`Total Files Size (in bytes):!
`
`228325
`
`This Acknowledgement Receipt evidences receipt on the noted date by the USPTO of the indicated documents,
`characterized by the applicant, and including page counts, where applicable. It serves as evidence of receipt
`similar to a Post Card, as described in MPEP 503.
`
`New Applications Under 35 U.S.C. 111
`If a new application is being filed and the application includes the necessary components for a filing date (see
`37 CFR 1.53(b)-(d) and MPEP 506), a Filing Receipt (37 CFR 1.54) will be issued in due course and the date
`shown on this Acknowledgement Receipt will establish the filing date of the application.
`
`National Stage of an International Application under 35 U.S.C. 371
`If a timely submission to enter the national stage of an international application is compliant with the conditions
`of 35 U.S.C. 371 and other applicable requirements a Form PCT/DO/E0/903 indicating acceptance of the
`application as a national stage submission under 35 U.S.C. 371 will be issued in addition to the Filing Receipt,
`in due course.
`
`New International Application Filed with the USPTO as a Receiving Office
`If a new international application is being filed and the international application includes the necessary
`components for an international filing date (see PCT Article 11 and MPEP 1810), a Notification of the
`International Application Number and of the International Filing Date (Form PCT/R0/105) will be issued in due
`course, subject to prescriptions concerning national security, and the date shown on this Acknowledgement
`Receipt will establish the international filing date of the application.
`
`903 of 1328
`
`Alkermes, Ex. 1076
`
`

`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`APPLICATION
`NUMBER
`10/556,600
`
`FILING or
`37l(c)DATE
`08/02/2006
`
`GRPART
`UNIT
`1617
`
`FIL FEE REC'D
`730
`
`23373
`SUGHRUE MION, PLLC
`2100 PENNSYLVANIA AVENUE, N.W.
`SUITE 800
`WASHINGTON, DC 20037
`
`UKITED STATES DEPARTME.\IT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIO'JER FOR PATENTS
`P.O. Box 1450
`Alexandria, V:irgmia 22313-1450
`\V\\lw.uspto.gov
`
`ATTY.DOCKET.NO
`Q81665
`
`TOT CLAIMS IND CLAIMS
`16
`2
`CONFIRMATION NO. 3822
`CORRECTED FILING RECEIPT
`
`111111111111111111111111]~!1~~~1~~1~~1~~u~ 11~1~111111111111111111111111
`
`Date Mailed: 11/21/2007
`
`Receipt is acknowledged of this non-provisional patent application. The application will be taken up for examination
`in due course. Applicant will be notified as to the results of the examination. Any correspondence concerning the
`application must include the following identification information: the U.S. APPLICATION NUMBER, FILING DATE,
`NAME OF APPLICANT, and TITLE OF INVENTION. Fees transmitted by check or draft are subject to collection.
`Please verify the accuracy of the data presented on this receipt. If an error is noted on this Filing Receipt, please
`write to the Office of Initial Patent Examination's Filing Receipt Corrections. Please provide a copy of this
`Filing Receipt with the changes noted thereon. If you received a "Notice to File Missing Parts" for this
`application, please submit any corrections to this Filing Receipt with your reply to the Notice. When the
`USPTO processes the reply to the Notice, the USPTO will generate another Filing Receipt incorporating the
`requested corrections
`
`Applicant(s)
`
`Tetsuro Kikuchi, Tokushima, JAPAN;
`Taro Iwamoto, Princeton, NJ;
`Tsuyoshi Hirose, Tokushima, JAPAN;
`Assignment For Published Patent Application
`OTSUKA PHARMACEUTICAL CO., LTD.
`Power of Attorney: The patent practitioners associated with Customer Number 23373
`
`Domestic Priority data as claimed by applicant
`This application is a 371 of PCT/US04/13308 05/19/2004
`
`Foreign Applications
`UNITED STATES OF AMERICA 60473378 05/23/2003
`
`If Required, Foreign Filing License Granted: 10/28/2006
`
`The country code and number of your priority application, to be used for filing abroad under the Paris Convention,
`is US 10/556,600
`
`Projected Publication Date: Not Applicable
`
`Non-Publication Request: No
`
`Early Publication Request: No
`
`page 1of3
`
`904 of 1328
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`
`

`
`Title
`
`Carbostyril derivatives and mood stabilizers for treating mood disorders
`
`Preliminary Class
`
`514
`
`PROTECTING YOUR INVENTION OUTSIDE THE UNITED STATES
`
`Since the rights granted by a U.S. patent extend only throughout the territory of the United States and have no
`effect in a foreign country, an inventor who wishes patent protection in another country must apply for a patent
`in a specific country or in regional patent offices. Applicants may wish to consider the filing of an international
`application under the Patent Cooperation Treaty (PCT). An international (PCT) application generally has the same
`effect as a regular national patent application in each PCT-member country. The PCT process simplifies the filing
`of patent applications on the same invention in member countries, but does not result in a grant of "an international
`patent" and does not eliminate the need of applicants to file additional documents and fees in countries where patent
`protection is desired.
`
`Almost every country has its own patent law, and a person desiring a patent in a particular country must make an
`application for patent in that country in accordance with its particular laws. Since the laws of many countries differ
`in various respects from the patent law of the United States, applicants are advised to seek guidance from specific
`foreign countries to ensure that patent rights are not lost prematurely.
`
`Applicants also are advised that in the case of inventions made in the United States, the Director of the US PTO must
`issue a license before applicants can apply for a patent in a foreign country. The filing of a U.S. patent application
`serves as a request for a foreign filing license. The application's filing receipt contains further information and
`guidance as to the status of applicant's license for foreign filing.
`
`Applicants may wish to consult the USPTO booklet, "General Information Concerning Patents" (specifically, the
`section entitled "Treaties and Foreign Patents") for more information on timeframes and deadlines for filing foreign
`patent applications. The guide is available either by contacting the USPTO Contact Center at 800-786-9199, or it
`can be viewed on the USPTO website at http://www.uspto.gov/web/offices/pac/doc/general/index.html.
`
`For information on preventing theft of your intellectual property (patents, trademarks and copyrights), you may wish
`to consult the U.S. Government website, http://www.stopfakes.gov. Part of a Department of Commerce initiative,
`this website includes self-help "toolkits" giving innovators guidance on how to protect intellectual property in specific
`countries such as China, Korea and Mexico. For questions regarding patent enforcement issues, applicants may
`call the U.S. Government hotline at 1-866-999-HAL T (1-866-999-4158).
`
`LICENSE FOR FOREIGN FILING UNDER
`
`Title 35, United States Code, Section 184
`
`Title 37, Code of Federal Regulations, 5.11 & 5.15
`
`GRANTED
`
`The applicant has been granted a license under 35 U.S.C. 184, if the phrase "IF REQUIRED, FOREIGN FILING
`LICENSE GRANTED" followed by a date appears on this form. Such licenses are issued in all applications where
`the conditions for issuance of a license have been met, regardless of whether or not a license may be required as
`page 2 of 3
`
`905 of 1328
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`Alkermes, Ex. 1076
`
`

`
`set forth in 37 CFR 5.15. The scope and limitations of this license are set forth in 37 CFR 5.15(a) unless an earlier
`license has been issued under 37 CFR 5.15(b). The license is subject to revocation upon written notification. The
`date indicated is the effective date of the license, unless an earlier license of similar scope has been granted under
`37 CFR 5.13 or 5.14.
`
`This license is to be retained by the licensee and may be used at any time on or after the effective date thereof unless
`it is revoked. This license is automatically transferred to any related applications(s) filed under 37 CFR 1.53(d). This
`license is not retroactive.
`
`The grant of a license does not in any way lessen the responsibility of a licensee for the security of the subject matter
`as imposed by any Government contract or the provisions of existing laws relating to espionage and the national
`security or the export of technical data. Licensees should apprise themselves of current regulations especially with
`respect to certain countries, of other agencies, particularly the Office of Defense Trade Controls, Department of
`State (with respect to Arms, Munitions and Implements of War (22 CFR 121-128)); the Bureau of Industry and
`Security, Department of Commerce (15 CFR parts 730-774); the Office of Foreign AssetsControl, Department of
`Treasury (31 CFR Parts 500+) and the Department of Energy.
`
`NOT GRANTED
`
`No license under 35 U.S.C. 184 has been granted at this time, if the phrase "IF REQUIRED, FOREIGN FILING
`LICENSE GRANTED" DOES NOT appear on this form. Applicant may still petition for a license under 37 CFR 5.12,
`if a license is desired before the expiration of 6 months from the filing date of the application. If 6 months has lapsed
`from the filing date of this application and the licensee has not received any indication of a secrecy order under 35
`U.S.C. 181, the licensee may foreign file the application pursuant to 37 CFR 5.15(b).
`
`page 3 of 3
`
`906 of 1328
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`Alkermes, Ex. 1076
`
`

`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`PATENT APPLICATION
`
`In re application of
`
`Tetsuro KIKUCHI, et al.
`
`Appln. No.: 10/556,600
`
`Confirmation No.: 3822
`
`Filed: August 2, 2006
`
`Docket No: Q81665
`
`Group Art Unit: 1617
`
`Examiner: Unknown
`
`For: CARBOSTYRIL DERIVATIVES AND MOOD STABILIZERS FOR TREATING
`MOOD DISORDERS
`
`INFORMATION DISCLOSURE STATEMENT
`UNDER 37 C.F.R. §§ 1.97 and 1.98
`MAIL STOP AMENDMENT
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`Sir:
`
`In accordance with the duty of disclosure under 3 7 C.F .R. § 1.56, Applicant hereby
`
`notifies the U.S. Patent and Trademark Office of the documents which are listed on the attached
`
`PTO/SB/08 A & B (modified) form and/or listed herein and which the Examiner may deem
`
`material to patentability of the claims of the above-identified application.
`
`One copy of each of the listed documents is submitted herewith, except for the following:
`
`U.S. patents and/or U.S. patent publications; and co-pending non-provisional U.S. applications
`
`filed after June 30, 2003.
`
`The present Information Disclosure Statement is being filed: (1) No later than three
`
`months from the application's filing date; (2) Before the mailing date of the first Office Action
`
`on the merits (whichever is later); or (3) Before the mailing date of the first Office Action after
`
`filing a request for continued examination (RCE) under§ 1.114, and therefore, no Statement
`
`under 37 C.F.R. § 1.97(e) or fee under 37 C.F.R. § 1.17(p) is required.
`
`907 of 1328
`
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`
`

`
`INFORMATION DISCLOSURE STATEMENT
`UNDER 37 C.F.R. §§ 1.97 and 1.98
`U.S. Appln. No.: 10/556,600
`
`Attorney Docket No.: Q81665
`
`The present Information Disclosure Statement is being filed thirty days or fewer from the
`
`communication from a foreign patent office and a Statement Under 37 C.F.R. §1.704(d) is
`
`attached.
`
`WO 03/026659 A and WO 02/060423 A, which were cited in the attached
`
`Supplementary Partial European Search Report for the corresponding European patent
`
`application were submitted with the USPTO form SB 08 (modified) filed with the
`
`Information Disclosure Statement dated November 14, 2005.
`
`The submission of the listed documents is not intended as an admission that any such
`
`document constitutes prior art against the claims of the present application. Applicant does not
`
`waive any right to take any action that would be appropriate to antedate or otherwise remove any
`
`listed document as a competent reference against the claims of the present application.
`
`The USPTO is directed and authorized to charge all required fees, except for the Issue
`
`Fee and the Publication Fee, to Deposit Account No. 19-4880. Please also credit any
`
`overpayments to said Deposit Account.
`
`Respectfully submitted,
`
`-tb#/14
`
`Registration No. 30,951
`
`SUGHRUE MION, PLLC
`Telephone: (202) 293-7060
`Facsimile: (202) 293-7860
`WASHINGTON OFFICE
`
`23373
`
`CUSTOMER NUMBER
`
`Date: June 17, 2008
`
`908 of 1328
`
`Alkermes, Ex. 1076
`
`

`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`PATENT APPLICATION
`
`In re application of
`
`Tetsuro KIKUCHI, et al.
`
`Appln. No.: 10/556,600
`
`Confirmation No.: 3822
`
`Filed: August 2, 2006
`
`Docket No: Q81665
`
`Group Art Unit: 1617
`
`Examiner: Unknown
`
`For: CARBOSTYRIL DERIVATIVES AND MOOD STABILIZERS FOR TREATING
`MOOD DISORDERS
`
`STATEMENT UNDER 37 C.F.R. § 1.704(d)
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`Sir:
`
`The undersigned hereby states, upon information and belief:
`
`That each item of information contained in the Information Disclosure Statement filed
`
`concurrently herewith was cited in a communication from a foreign patent office in a counterpart
`
`foreign application, and that the communication was not received by any individual designated in
`
`3 7 C.F .R. § 1.56( c) more than thirty days prior to the filing of said Information Disclosure
`
`Statement.
`
`Respectfully submitted,
`
`Registration No. 30,951
`
`SUGHRUE MION, PLLC
`Telephone: (202) 293-7060
`Facsimile: (202) 293-7860
`WASHINGTON OFFICE
`
`23373
`
`CUSTOMER NUMBER
`
`Date: June 17, 2008
`
`909 of 1328
`
`Alkermes, Ex. 1076
`
`

`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`(Not for submission under 37 CFR 1.99)
`
`APPiication Number
`Confirmation Number
`Filing Date
`First Named Inventor
`Art Unit
`Examiner Name
`Attorney Docket Number
`
`MODIFIED PTO/SB/08a (05-07)
`I
`Aooroved for use throuah 11/30 2007.
`10/556,600
`3822
`August2,2006
`Tetsuro KIKUCHI
`1617
`Unknown
`081665
`
`Examiner
`Initials*
`
`Cite No
`
`Patent Number
`
`Kind Code1
`
`Issue Date
`
`Name of Patentee or
`Applicant of cited Document
`
`Pages, Columns, Lines,
`Where Relevant Passages or
`Relevant Figures Appear
`
`1.
`
`U.S. PATENTS
`
`Examiner
`Initials*
`
`Cite No
`
`Publication Number
`
`Kind Code1
`
`Publication Date
`
`Name of Patentee or
`Applicant of cited Document
`
`Pages, Columns, Lines,
`Where Relevant Passages or
`Relevant Figures Appear
`
`U.S. PATENT APPLICATION PUBLICATIONS
`
`1.
`
`Examiner
`Initials*
`
`Cite No
`
`Foreign
`Document
`Number3
`
`Count~
`Code
`
`Kind
`Code4
`
`Publication
`Date
`
`Name of Patentee or
`Applicant of cited
`Document
`
`Pages, Columns,
`Lines, Where Relevant
`Passages or Relevant
`Fiaures Aooear
`
`FOREIGN PATENT DOCUMENTS
`
`1.
`
`Examiner
`Initials*
`
`Cite No
`
`1.
`
`2.
`
`3.
`
`4.
`
`NON-PATENT LITERATURE DOCUMENTS
`Include name of the author (in CAPITAL LETTERS), title of the article (when appropriate), title of the item
`(book, magazine, journal, serial, symposium, catalog, etc.), date, page(s), volume-issue number(s),
`publisher, city, and/or countrv where published.
`BORWIN BANDELOW and ANDREAS MEIER; Aripiprazole, a "Dopamine-Serotonin System Stabilizer''
`in the Treatment of Psychosis; German Journal of Psvchiatrv, vol. 6, no. 1, 2003; oaaes 9-16
`MELISSA P. DELBELLO, M. D., ET AL.; A Double-Blind, Randomized, Placebo-Controlled Study of
`Quetiapine as Adjunctive Treatment for Adolescent Mania; Journal of the American Academy of Child
`and Adolescent Psvchiatrv, vol. 41, no. 10, 2002, paaes 1216-1223
`MAURICIO TOHEN, M.D. ET AL.; Efficacy of Olanzapine in Combination with Valproate or Lithium in the
`Treatment of Mania in Patients Partially Nonresponsive to Valproate or Lithium Monotherapy; Archives of
`General Psvchiatrv, vol. 59, no. 1, 2002, pages 62-69
`FRANK I. TARAZI, ET AL., Long-term effects of olanzapine, risperidone, and quetiapine on serotonin 1A,
`2A and 2C receptors in rat forebrain regions; Psychopharmacology, vol. 161, no. 3, 2002, page 263-270
`
`Ts
`
`Ts
`
`Examiner
`SiQnature
`
`I
`
`EXAMINER SIGNATURE
`
`I Date
`
`Considered
`
`I
`
`*EXAMINER: Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through a citation if not in conformance and not considered.
`Include copy of this form with next communication to applicant.
`1 See Kind Codes of USPTO Patent Documents at www.USPTO.GOV or MPEP 901.04. 2 Enter office that issued the document, by the two-letter code (WIPO Standard ST.3).
`3 For Japanese patent documents, the indication of the year of the reign of the Emperor must precede the serial number of the patent document. 4 Kind of document by the
`appropriate symbols as indicated on the document under WIPO Standard ST.16 if possible. 5 Applicant is to place a check mark here if English language translation is
`attached.
`
`[Page 1 of 2]
`
`910 of 1328
`
`Alkermes, Ex. 1076
`
`

`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`(Not for submission under 37 CFR 1.99)
`
`Aoolication Number
`Confirmation Number
`Filinq Date
`First Named Inventor
`Art Unit
`Examiner Name
`Attorney Docket
`Number
`
`MODIFIED PTO/SB/OBa (05-07)
`Approved for use through 11 /30/2007.
`10/556,600
`3822
`Auqust 2, 2006
`Tetsuro KIKUCHI
`1617
`Unknown
`
`081665
`
`Please see 37 CFR 1.97 and 1.98 to make the appropriate selection(s):
`
`CERTIFICATION STATEMENT
`
`D
`
`That each item of information contained in the information disclosure statement was first cited in any communication
`from a foreign patent office in a counterpart foreign application not more than three months prior to the filing of the
`information disclosure statement. See 37 CFR 1.97(e)(1).
`
`OR
`
`That no item of information contained in the information disclosure statement was cited in a communication from a
`foreign patent office in a counterpart foreign application, and, to the knowledge of the person signing the certification
`D after making reasonable inquiry, no item of information contained in the information disclosure statement was
`known to any individual designated in 37 CFR 1.56(c) more than three months prior to the filing of the information
`disclosure statement. See 37 CFR 1.97(e)(2).
`
`0 See attached certification statement.
`D Fee set forth in 37 CFR 1.17 (p) has been submitted herewith.
`0 The USPTO is directed and authorized to charge all required fees, except for the Issue Fee and the Publication Fee
`to Deposit Account No. 19-4880. Please also credit any overpayments to said Deposit Account.
`D None
`
`[en]
`
`SIGNATURE
`
`A signature of the applicant or representative is required in accordance with CFR 1.33, 10.18. Please see CFR 1.4(d) for
`the form of the signature/'?
`
`Signature
`
`Name/Print
`
`X /,.., ~ (} /Jt.4~
`Su~an J. Ma{k
`
`Date (YYYY-MM-DD)
`
`2008-06-17
`
`Registration Number
`
`30,951
`
`This collection of information is required by 37 CFR 1.97 and 1.98. 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 1 hour 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, P.O. Box
`1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO:
`Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`
`*EXAMINER: Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through a citation if not in conformance and not considered.
`Include copy of this form with next communication to applicant.
`1 See Kind Codes of USPTO Patent Documents at www.USPTO.GOV or MPEP 901.04. 2 Enter office that issued the document, by the two-letter code (WIPO Standard ST.3).
`3 For Japanese patent documents, the indication of the year of the reign of the Emperor must precede the serial number of the patent document. 4 Kind of document by the
`appropriate symbols as indicated on the document under WIPO Standard ST.16 if possible. 5 Applicant is to place a check mark here if English language translation is
`attached.
`
`[Page 1of2]
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`911 of 1328
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`Alkermes, Ex. 1076
`
`

`
`Electronic Acknowledgement Receipt
`
`EFSID:
`
`Application Number:
`
`3472627
`
`10556600
`
`International Application Number:
`
`Confirmation Number:
`
`3822
`
`Title of Invention:
`
`Carbostyril derivatives and mood stabilizers for treating mood disorders
`
`First Named Inventor/Applicant Name:
`
`Tetsuro Kikuchi
`
`Customer Number:
`
`23373
`
`Filer:
`
`Susan Joan Mack/deangela williams
`
`Filer Authorized By:
`
`Susan Joan Mack
`
`Attorney Docket Number:
`
`081665
`
`Receipt Date:
`
`Filing Date:
`
`Time Stamp:
`
`17-JUN-2008
`
`02-AUG-2006
`
`18:03:11
`
`Application Type:
`
`U.S. National Stage under 35 USC 371
`
`Payment information:
`
`Submitted with Payment
`
`I no
`
`File Listing:
`
`Document
`Number
`
`Document Description
`
`File Name
`
`File Size(Bytes)
`Pages
`Multi
`/Message Digest Part /.zip (if appl.}
`
`108242
`
`1
`
`Q816551DSstatements.PDF
`
`yes
`
`3
`
`cd929165d2bb43898e7bc24a292a269
`6ea91c93d
`
`912 of 1328
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`Alkermes, Ex. 1076
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`

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`Multipart Description/PDF files in .zip description
`
`Document Description
`
`Start
`
`End
`
`Information Disclosure Statement Letter
`
`Information Disclosure Statement Letter
`
`2
`
`3
`
`1
`
`3
`
`154521
`
`Q81665SB08.PDF
`
`no
`
`2
`
`a7b285cf406c3df6d09ee44c6b30e68c3
`7dbd6d2
`
`Warnings:
`
`Information:
`
`2
`
`Information Disclosure Statement
`(IDS) Filed
`
`Warnings:
`
`Information:
`
`This is not an USPTO supplied IDS fillable form
`
`3
`
`NPL Documents
`
`Q81665NPL.PDF
`
`no
`
`6
`
`222619
`
`Warnings:
`
`Information:
`
`4a1 b0a4723fd601 03987b36f8d51d26e
`a54a61e3
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`789358
`
`4
`
`NPL Documents
`
`Q81665NPL 1.PDF
`
`no
`
`8
`
`Warnings:
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`Information:
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`25a811 0256c0654a3d520d7b4391 af2e
`70d1330d
`
`778840
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`5
`
`NPL Documents
`
`Q81665NPL2.PDF
`
`no
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`8
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`Warnings:
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`Information:
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`348741daa44cc2d47ed2021 a1 5f30e78
`aee92b3d
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`823863
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`6
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`NPL Documents
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`Q81665NPL3.PDF
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`no
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`8
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`Warnings:
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`613aa02e3f6c7dcc163a97b0cf62956cd
`ffed669
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`838142
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`NPL Documents
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`Q81665NPL4.PDF
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`no
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`3715585
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`913 of 1328
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`

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`This Acknowledgement Receipt evidences receipt on the noted date by the USPTO of the indicated documents,
`characterized by the applicant, and including page counts, where applicable. It serves as evidence of receipt
`similar to a Post Card, as described in MPEP 503.
`
`New Applications Under 35 U.S.C. 111
`If a new application is being filed and the application includes the necessary components for a filing date (see
`37 CFR 1.53(b)-(d) and MPEP 506), a Filing Receipt (37 CFR 1.54) will be issued in due course and the date
`shown on this Acknowledgement Receipt will establish the filing date of the application.
`
`National Stage of an International Application under 35 U.S.C. 371
`If a timely submission to enter the national stage of an international application is compliant with the conditions
`of 35 U.S.C. 371 and other applicable requirements a Form PCT/DO/E0/903 indicating acceptance of the
`application as a national stage submission under 35 U.S.C. 371 will be issued in addition to the Filing Receipt,
`in due course.
`
`New International Application Filed with the USPTO as a Receiving Office
`If a new international application is being filed and the international application includes the necessary
`components for an international filing date (see PCT Article 11 and MPEP 1810), a Notification of the
`International Application Number and of the International Filing Date (Form PCT/R0/105) will be issued in due
`course, subject to prescriptions concerning national security, and the date shown on this Acknowledgement
`Receipt will establish the international filing date of the application.
`
`914 of 1328
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`

`
`UNITED STA IBS p A IBNT AND TRADEMARK OFFICE
`
`UNITED STA TES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`10/556,600
`
`08/02/2006
`
`Tetsuro Kikuchi
`
`Q81665
`
`3822
`
`01/26/2009
`
`23373
`7590
`SUGHRUE MION, PLLC
`2100 PENNSYLVANIA A VENUE, N .W.
`SUIIB 800
`WASHINGTON, DC 20037
`
`EXAMINER
`
`KANTAMNENI, SHOBHA
`
`ART UNIT
`
`PAPER NUMBER
`
`1617
`
`MAILDATE
`
`DELIVERY MODE
`
`01/26/2009
`
`PAPER
`
`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.
`
`PTOL-90A (Rev. 04/07)
`
`915 of 1328
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`Alkermes, Ex. 1076
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`

`
`Office Action Summary
`
`Application No.
`
`Applicant(s)
`
`10/556,600
`
`Examiner
`
`KIKUCHI ET AL.
`
`Art Unit
`
`1617
`Shobha Kantamneni
`-- 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 1 MONTH(S) OR THIRTY (30) DAYS,
`WHICHEVER IS LONGER, FROM THE MAILING DATE OF THIS COMMUNICATION.
`- Extensions of time may be available under the provisions of 37 CFR 1.136(a). In no event, however, may a reply be timely filed
`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).
`
`Status
`
`1)0 Responsive to communication(s) filed on __ .
`2a)0 This action is FINAL.
`2b)0 This action is non-final.
`3)0 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 Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`Disposition of Claims
`
`4)~ Claim(s) 1-16 is/are pending in the application.
`4a) Of the above claim(s) __ is/are withdrawn from consideration.
`5)0 Claim(s) __ is/are allowed.
`6)0 Claim(s) __ is/are rejected.
`7)0 Claim(s) __ is/are objected to.
`8)~ Claim(s) 1-16 are subject to restriction and/or election requirement.
`
`Application Papers
`
`9)0 The specification is objected to by the Examiner.
`10)0 The drawing(s) filed on __ is/are: a)O accepted or b)O 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).
`11 )0 The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PT0-152.
`
`Priority under 35 U.S.C. § 119
`
`12)0 Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`a)O All b)O Some* c)O None of:
`1.0 Certified copies of the priority documents have been received.
`2.0 Certified copies of the priority documents have been received in Application No. __ .
`3.0 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)
`1) 0 Notice of References Cited (PT0-892)
`2) 0 Notice of Draftsperson's Patent Drawing Review (PT0-948)
`3) 0 Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date __ .
`
`4) 0 Interview Summary (PT0-413)
`Paper No(s)/Mail Date. __ .
`5) 0 Notice of Informal Patent Application
`6) 0 Other: __ .
`
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 08-06)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20090111
`
`916 of 1328
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`Alkermes, Ex. 1076
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`

`
`Application/Control Number: 10/556,600
`Art Unit: 1617
`
`Page 2
`
`DETAILED ACTION
`
`This application is a 371 of PCT/US04/13308, filed on 05/19/2004.
`
`Election/Restrictions
`
`This application contains claims directed to more than one species of the generic
`
`invention. These species are deemed to lack unity of invention because they are not so
`
`linked as to form a single general inventive concept under PCT Rule 13.1.
`
`The species are as follows:
`
`1) a plurality of disclosed patentably distinct mood stabilizers as in claim 5.
`
`Applicant is required, in a reply to this action, to elect a single specified mood
`
`stabilizer for the prosecution on the merits to which the claims shall be restricted if no
`
`generic claim is finally held to be allowable.
`
`Currently, Claims 1-16 are generic to a plurality of disclosed patentably distinct
`
`species mood stabilizers. The claims 1-16 read on
`
`the employment of various
`
`compounds with great diversity of chemical structure classified across class 514, the
`
`search for all of which presents an undue burden