UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Addn:ss: COMMISSIONER FOR PA TENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`NOTICE OF ALLOWANCE AND FEE(S) DUE
`
`04/04/2005
`
`7590
`Stephen A. Bent
`FOLEY & LARDNER
`Washington Harbour
`3000 K Street, N.W., Suite SOO
`Washington, DC 20007-Sl09
`
`EXAMINER
`
`KAM, CHIH MIN
`
`ART UNIT
`
`PAPER NUMBER
`
`1653
`
`DA TE MAILED: 04/04/2005
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`091750,022
`
`12/29/2000
`
`Indu J. Isaacs
`
`016777/0454
`
`6419
`
`TITLE OF INVENTION: GLP-2 FORMULATIONS
`
`APPLN.TYPE
`
`SMALL ENTITY
`
`nonprovisional
`
`NO
`
`ISSUE FEE
`
`$1400
`
`PUBLICATION FEE
`
`TOT AL FEE(S) DUE
`
`$300
`
`$1700
`
`DATE DUE
`
`07/05/2005
`
`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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`THIS
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`SEE 35 U.S.C. 151. THE ISSUE FEE DUE INDICATED ABOVE
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`II. PART B - FEE(S) TRANSMITTAL should be completed and returned to the United States Patent and Trademark Office (USPTO) with
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`PTOL-85 (Rev. 12/04) Approved for use through 04/3012007.
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`Page I of 3
`
`CFAD Exhibit 1017
`
`1
`
`

`

`PART B - FEE(S) TRANSMITTAL
`
`Complete and send this form, together with applicable fee(s), to: Mail Mail Stop ISSUE FEE
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`or Fax
`(703) 746-4000
`INSTRUCTIONS: This form should be used for transmitting the ISSUE FEE and PUBLICATION FEE (if required). Blocks I through 5 should be completed where
`appropriate. All further correspondence including the Patent, advance orders and notification of maintenance fees will be mailed to the current correspondence address as
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`maintenance fee notifications.
`CURRENT CORRESPONDENCE ADDRESS (Note: Use Block I for any change of address)
`
`04/04/2005
`
`7590
`Stephen A. Bent
`FOLEY & LARDNER
`Washington Harbour
`3000 K Street, N.W., Suite 500
`Washington, DC 20007-5109
`
`Note: A certificate of mailing can only be used for domestic mailings of the
`Fee(s) Transmittal. This certificate cannot be used for any other accompanying
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`Certificate of Mailing or Transmission
`I hereby certify that this Fee(s) Transmittal is being deposited with the United
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`addressed to the Mail Stop ISSUE FEE address above, or being facsimile
`transmitted to the USPTO (703) 746-4000 on the date indicated below.
`
`(Depositor's name)
`
`(Signature)
`
`(Date)
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`I ATTORNEY DOCK.ET NO.
`
`CONFIRMATION NO.
`
`09/750,022
`
`12/29/2000
`
`lndu J. Isaacs
`
`016777/0454
`
`6419
`
`TITLE OF INVENTION: GLP-2 FORMULATIONS
`
`APPLN. TYPE
`
`nonprovisional
`
`SMALL ENTITY
`
`NO
`
`EXAMINER
`
`KAM, CHIH MIN
`
`ISSUE FEE
`
`$1400
`
`ART UNIT
`
`1653
`
`PUBLICATION FEE
`
`TOT AL FEE(S) DUE
`
`$300
`
`$1700
`
`DATE DUE
`
`07/05/2005
`
`CLASS-SUBCLASS
`
`514.{) 12000
`
`I. Change of correspondence address or indication of "Fee Address" (37
`CFR 1.363).
`0 Change of correspondence address (or Change of Correspondence
`Address form PTO/SB/122) attached.
`0 "Fee Address" indication (or "Fee Address" Indication form
`PTO/SB/47; Rev 03-02 or more recent) attached. Use of a Customer
`Number is required.
`
`2. For printing on the patent front page, list
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`or agents OR, alternatively,
`(2) the name of a single firm (having as a member a
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`listeo, no name will be printed.
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`2. ________ _____ _
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`3. ASSIGNEE NAME AND RESIDENCE DAT A TO BE PRINTED ON THE PA TENT (print or type)
`PLEASE NOTE: Unless an assignee is identified below, no assignee data will appear on the patent. If an assignee is identified below, the document has been filed for
`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)
`
`Please check the appropriate assignee category or categories (will not be printed on the patent): 0 Individual 0 Corporation or other private group entity 0 Government
`4b. Payment of Fee(s):
`4a. The following fee(s) are enclosed:
`0 Issue Fee
`0 A check in the amount of the fee(s) is enclosed.
`0 Publication Fee (No small entity discount permitted)
`0 Payment by credit card. Form PT0-2038 is attached.
`0 Advance Order - #of Copies
`0 The Director is hereby authorized by charge the required fee(s), or credit any overpayment, to
`Deposit Account Number
`(enclose an extra copy ofth1s form).
`
`5. Change in Entity Status (from status indicated above)
`0 a. Applicant claims SMALL ENTITY status. See 37 CFR 1.27.
`0 b. Applicant is no longer claiming SMALL ENTITY status. See 37 CFR I .27(g)(2).
`The Director of the USPTO is requested to apply the Issue Fee and Publication Fee (if any) or to re-apply any previously paid issue fee to the application identified above.
`NOTE: The Issue Fee and Publication Fee (if required) will not be accepted from anyone other than the applicant; a registered attorney or agent; or the assignee or other party in
`interest as shown by the records of the United States Patent and Trademark Office.
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`Authorized Signature ___ _ __ __ __ _ ___ _ _ _ ___ _ _
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`Typed or printed name _______________ __ ___ _
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`Registration No . - - - - - - - - - - - - - -
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`This collection of information 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 flOVerned by 35 U.S.C. 122 and 37 CFR 1.14. This collection is estimated to take 12 minutes to complete, including gathering, prepanng, and
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`this form and/or suggestions for reducing this burden, should be sent to the Chieflnformation Officer, U.S. Patent and Trademark Office, U.S. Department of Commerce, P.O.
`Box 1450, Alexandria, Virginia 22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, P.O. Box 1450,
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`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information Wlless it displays a valid OMB control number.
`
`PTOL-85 (Rev. 12/04) Approved for use through 04/30/2007.
`
`OMB 0651-0033
`
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`
`2
`
`

`

`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PA TENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`091750,022
`
`12/29/2000
`
`lndu J. Isaacs
`
`016777/0454
`
`6419
`
`04/04/2005
`
`7590
`Stephen A. Bent
`FOLEY & LARDNER
`Washington Harbour
`3000 K Street, N.W., Suite 500
`Washington, DC 20007-5109
`
`EXAMINER
`
`KAM, CHIH MIN
`
`ART UNIT
`
`PAPER NUMBER
`
`1653
`
`DA TE MAILED: 04/04/2005
`
`Determination of Patent Term Adjustment under 35 U.S.C.154 (b)
`(application filed on or after May 29, 2000)
`
`The Patent Term Adjustment to date is 0 day(s). If the issue fee is paid on the date that is three months after the
`mailing date of this notice and the patent issues on the Tuesday before the date that is 28 weeks (six and a half
`months) after the mailing date of this notice, the Patent Term Adjustment will be 0 day(s).
`
`If a Continued Prosecution Application (CPA) was filed in the above-identified application, the filing date that
`determines Patent Term Adjustment is the filing date of the most recent CPA.
`
`Applicant will be able to obtain more detailed information by accessing the Patent Application Information Retrieval
`(PAIR) WEB site (http://pair.uspto.gov).
`
`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 (703) 305-8283.
`
`PTOL-85 (Rev. 12104) Approved for use through 04/30/2007.
`
`Page 3 of 3
`
`3
`
`

`

`Notice of Allowability
`
`Application No.
`
`Applicant(s)
`
`09/750,022
`Examiner
`
`Chih-Min Kam
`
`ISAACS, INDU J.
`Art Unit
`
`1653
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address-(cid:173)
`All daims 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. [gl This communication is responsive to 1104105.
`
`2. [gl The allowed claim(s) is/are 1-51.53-55 and 58-78.
`
`3. [gl The drawings filed on 29 December 2000 are accepted by the Examiner.
`
`4. [gl Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`b) D Some*
`c) D None
`a) [81 All
`of the:
`1. [81 Certified copies of the priority documents have been received.
`2. D Certified copies of the priority documents have been received in Application No. __ .
`3. D 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)).
`* Certified copies not received: __ .
`
`Applicant has THREE MONTHS FROM THE "MAILING DATE" of this communication to file a reply complying with the requirements
`noted below. Failure to timely comply will result in ABANDONMENT of this application.
`THIS THREE-MONTH PERIOD IS NOT EXTENDABLE.
`5. 0 A SUBSTITUTE OATH OR DECLARATION must be submitted. Note the attached EXAMINER'S AMENDMENT or NOTICE OF
`INFORMAL PATENT APPLICATION (PT0-152) which gives reason(s) why the oath or declaration is deficient.
`6. D CORRECTED DRAWINGS ( as "replacement sheets") must be submitted.
`(a) D including changes required by the Notice of Draftsperson's Patent Drawing Review ( PT0-948) attached
`1) D hereto or 2) D to Paper No./Mail Date __ .
`(b) D induding changes required by the attached Examiner's Amendment I Comment or in the Office action of
`Paper No./Mail Date __ .
`
`Identifying indicia such as the application number (sea 37 CFR 1.84(c)) should be written on the drawings in the front (not the back) of
`each sheet. Replacement shaat(s) should be labeled as such in the header according to 37 CFR 1.121(d).
`7. 0 DEPOSIT OF and/or INFORMATION about the deposit of BIOLOGICAL MATERIAL must be submitted. Note the
`attached Examiner's comment regarding REQUIREMENT FOR THE DEPOSIT OF BIOLOGICAL MATERIAL.
`
`Attachment(s)
`1. [81 Notice of References Cited (PT0-892)
`2. D Notice of Draftperson's Patent Drawing Review (PT0-948)
`3. D Information Oisdosure Statements (PT0-1449 or PTO/SB/08),
`Paper No./Mail Date __
`4. D Examiner's Comment Regarding Requirement for Deposit
`of Biological Material
`
`5. D Notice of Informal Patent Application (PT0-152)
`6. 1:81 Interview Summary (PT0-413),
`Paper No./Mail Date 20050323 .
`7. [81 Examiner's AmendmenVComment
`
`8. [81 Examiner's Statement of Reasons for Allowance
`9. D Other __ .
`
`U.S. Paten! ard Trademark Office
`PTOL-37 (Rev. 1-04)
`
`Notice of Allowability
`
`Part of Paper No./Mail Date 20050323
`
`4
`
`

`

`Application/Control Number: 091750,022
`Art Unit: 1653
`
`Page 2
`
`An Examiner's Amendment to the record appears below. Should the changes and/or additions
`be unacceptable to applicant, an amendment may be filed as provided by 37 CFR 1.312. To
`ensure consideration of such an amendment, it MUST be submitted no later than the payment of
`the issue fee.
`
`Authorization for this examiner's amendment was given in a telephone interview with
`Michele Simkin on March 23, 2005.
`
`Examiner's Amendments to the Claims:
`
`Cancel claim 52.
`
`Claim 59 has been amended as follows:
`
`59.
`
`(Currently amended) The GLP-2 formulation of claim 21, wherein the GLP-
`
`2 receptor antagonist has either ( 1) an amino acid substitution selected from the group
`
`consisting of Asp15
`
`, Phe22
`
`, Thr29
`
`, Thr32
`
`, Asp33
`
`, and combinations thereof; or (2) an amino
`
`acid substitution of Ala at position 2 by an amino acid selected from the group consisting
`
`of Leu, Cys, Glu, Arg, Trp and P03-Tyr, wherein the residue or position for the amino
`
`acid substitution is numbered according to a mammalian GLP-2.
`
`The following is an Examiner's Statement of Reasons for Allowance: The following
`references appear to be the closest art to the claimed invention. Knudsen et al. (WO 99/43361)
`teach a pharmaceutical composition comprising a GLP-2 derivative or analog, an isotonic agent
`such as mannitol, a buffer of histidine or sodium phosphate, a pharmaceutical acceptable carrier,
`a preservative and a surfactant; Komfelt et al. (U. S. Patent 5,652,216) disclose using stabilizing
`amount of a pharmaceutically acceptable ampholyte such as glycine, histidine or GlyGly in a
`pharmaceutical preparation comprising glucagons. However, Knudsen et al. either alone or in
`combination with Komfelt et al. do not teach or suggest a GLP-2 formulation comprising a
`medically useful amount of GLP2 or an analog thereof, a phosphate buffer, L-histidine for
`stabilizing the formulation and a bulking agent of mannitol and sucrose. Buhl et al. (J. Biol.
`Chem 263, 8621-8624 (1988)) teach amino acid sequences of GLP-2 from different species; and
`Lund et al. (J. Biol. Chem. 258, 3280-3284 (1983)) teach nucleotide and corresponding deduced
`amino acid sequences of cDNA encoding two anglerfish pre-proglucagons, where the GLP-2
`sequence in the angler fish pre-proglucagon is different from the mammalian GLP-2. Therefore,
`the claims are allowable over the art of record
`
`5
`
`

`

`Application/Control Number: 09/750,022
`Art Unit: 1653
`
`Page 3
`
`Any comments considered necessary by applicant must be submitted no later than the
`payment of the issue fee and, to avoid processing delays, should preferably accompany the issue
`fee. Such submissions should be clearly labeled "Comments on Statement of Reasons for
`Allowance."
`
`Any inquiry concerning this communication or earlier communications from the
`examiner should be directed to Chih-Min Kam whose telephone number is (571) 272-0948. The
`examiner can normally be reached on 8.00-4:30, Mon-Fri.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
`supervisor, Jon Weber can be reached at 571-272-0925. 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).
`
`Chih-Min Kam, Ph. D.
`
`Patent Examiner
`
`CMK
`
`March 23, 2005
`
`JON WEBER
`SUPERVISORY PATENT EXAMINER
`
`6
`
`