`
`UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Oflice
`Adams: COMMISSIONER FOR PATENTS
`PO. Box I450
`_
`Alexandria. Virginia 213 I3-l450
`www.mptngov
`
`NOTICE OF ALLOWANCE AND FEE(S) DUE
`
`Michael A Sanzo
`Fitch Even Tabin & Flannery
`180] K Street Nw Suite 4011
`Washinton, DC 20006-1201
`
`SPEAK. JAMES M
`
`1615
`DATE MAILED: 03/29/2005
`
`John R. Plachetka
`05/3 I/2002
`[0“ 58,216
`TITLE OF INVENTION: PHARMACEUTICAL COMPOSITIONS FOR THE COORDINATED DELIVERY OF NSAIDS
`
`7569/7328]
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`-
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`5014
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`APPLN. TYPE
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`nonprovisional
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`SMALL ENTITY
`YES
`
`ISSUE FEE
`$700
`
`PUBLICATION FEE
`
`TOTAL FEE(S) DUE
`
`$300
`
`$1000
`
`DATE DUE
`
`06/29/2005
`
`THE APPLICATION IDENTIFIED ABOVE HAS BEEN EXAMINED AND IS ALLOWED FOR ISSUANCE AS A PATENT.
`PROSECUTION O_N, THE MERITS E 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 0R UPON
`PETITION BY THE APPLICANT. SEE 37 CFR 1.313 AND MPEP 1308.
`'
`
`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.
`THIS
`STATUTORY PERIOD CANNOT BE EXTENDED.
`SEE 35 U.S.C. 151. THE ISSUE FEE DUE INDICATED ABOVE
`REFLECTS A CREDIT FOR ANY PREVIOUSLY PAID ISSUE FEE APPLIED IN THIS APPLICATION. THE PTOL-SSB (0R
`AN EQUIVALENT) MUST BE RETURNED WITHIN THIS PERIOD EVEN IF NO FEE IS DUE OR THE APPLICATION WILL
`BE REGARDED AS ABANDONED.
`
`HOW TO REPLY TO THIS NOTICE:
`
`I. Review the SMALL ENTITY Status shown above.
`
`If the SMALL ENTITY is shown as YES, verify your current
`SMALL ENTITY status:
`‘
`
`If the SMALL ENTITY is shown as NO:
`
`A. If the status is the same, pay the TOTAL FEE(S) DUE shown
`above.
`
`A. Pay TOTAL FEE(S) DUE shown above, or
`
`B. If the status above is to be removed, check box 5b on Part B -
`Fee(s) Transmittal and pay the PUBLICATION FEE (if required)
`and twice the amount of the ISSUE FEE shown above, or
`’
`
`B. If applicant claimed SMALL ENTITY status before, or is now
`claiming SMALL ENTITY status, check box 5a on Part B - Fee(s)
`Transmittal and pay the PUBLICATION FEE (if required) and Hz
`the ISSUE FEE shown above.
`
`[1. PART B - FEE(S) TRANSMITTAL Should be completed and returned to the United States Patent and Trademark Office (USPTO) with
`your ISSUE FEE and PUBLICATION FEE (if required). Even if the fee(s) have already been paid, Part B - Fee(s) Transmittal should be
`completed and returned. If you are charging the fee(s) to your deposit account, section "4b" of Part B - Fee(s) Transmittal should be
`completed and an extra copy of the form Should be submitted.
`
`III. All communications regarding this application must give the application number. Please direct all communications prior to issuance to
`Mail Stop ISSUE FEE unless advised to the contrary.
`
`IMPORTANT REMINDER: Utility patents issuing on applications filed on or after Dec. 12, 1980 may require payment of
`maintenance fees. It is patentee's responsibility to ensure timely payment of maintenance fees when due.
`
`PTOL-85 (Rev. 12/04) Approved for use through 04/30/2007.
`
`CFAD EXHIBIT 1027
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`Page I of 3
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`

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`PART B - FEE(S) TRANSMITTAL
`
`Complete and send this form, together with applicable fee(s), to: Mafl Mail Stop ISSUE FEE
`'
`Commissioner for Patents
`PO. Box 1450
`Alexandria, Virginia 22313-1450
`or Ea);
`(703) 746-4000
`—___________——_—__———-——
`INSTRUCTIONS: This form should be used for transmitting the ISSUE FEE and PUBLICATION FEE (if required . Blocks 1
`through 5 should be completed where
`ap ropn‘ate. All further correspondence including the Patent, advance orders and notification of maintenance fees will
`mailed to the current corres ondence address as
`in icated unless corrected below or directed otherwise in Block 1, by (a) specifying a new correspondence address; and/or (b) indicating a separate " EE ADDRESS" for
`maintenance fee notifications.
`_——_—___—___—'—-———-—————
`CURRENT CORRESPONDENCE ADDRESS ("Wius‘ 31"“ ' 10"“ “m8” Mm)
`Note: A certificate ofmailing can only be used for domestic mailings of the
`Fee(s) Transmittal.~ This cem icate cannot be _used for any other accompanying
`papers. Each additional paper, such as an assrgnment or formal drawrng, must
`ave its own certificate of mailing or transmissron.
`
`03/29/2005
`
`7590
`
`Michael A Sanzo
`'
`-
`FltCh Even Tabm & Flannery
`1801 K Street NW SUIte 4011
`Washinton, DC 20006-1201
`
`~
`
`Certificate of Mailing or Transmission
`that this Fee 5 Transmittal is being deposited with the United
`I hereb certi
`ervice with su icient postage for first class mail in an envelope
`States ostal
`addressed to the Mail Stop ISSUE FEE address above, or bein
`facsrmile
`transmitted to the USPTO ( 03) 746—4000, on the date indicated be ow.
`
`
`
`
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`‘
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`John R. Plachetka
`05/31/2002
`10/158,216
`TITLE OF INVENTION: PHARMACEUTICAL COMPOSITIONS FOR THE COORDINATED DELIVERY OF NSAIDS
`
`7569/73281
`
`5014
`
`APPLN. TYPE
`
`nonprovisional
`
`SMALL ENTITY
`YES
`
`EXAMINER
`
`ISSUE FEE
`
`‘
`
`$700
`
`ART UNIT
`
`PUBLICATION FEE
`3300
`
`CLASS-SUBCLASS
`
`TOTAL FEE(S) DUE
`
`3 I 000
`
`DATE DUE
`
`06/29/2005
`
`SPEAR, JAMES M
`
`1615
`424472000
`
` 2. For printing on the patent front page, list
`
`1. Chan e of correspondence address or indication of "Fee Address" (37
`CFR 1. 63).
`(1) the names of up to 3 registered patent attorneys
`
`or agents OR, alternatively,
`D Chan e of corres ondence address (or Change of Correspondence
`
`Address orm PTO/ B/ 122) attached.
`
`(2) the name of a single firm (having as a member a 2_.———————
`registered attorney or agent) and the names of up to
`
`0 "Fee Address" indication (or "Fee Address" Indication form
`
`2 registered patent attorneys or agents. If no name is
`3
`PTO/SB/47; Rev 03-02 or more recent) attached. Use of a Customer
`
`listed, no name will be printed.
`Number 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 CF 3.1 I. Completion of this form is NOT a substitute for filing an assignment.
`
`
`
`(A) NAME OF ASSIGNEE
`
`‘
`
`(B) RESIDENCE: (CITY and STATE OR COUNTRY)
`
`[:1 Corporation or other private group entity D Government
`Please check the appropriate assignee category or categories (will not be printed on the patent) : D Individual
`________—_—_—___——————————————
`4a. The following fee(s) are enclosed:
`4b. Payment of Fee(s):
`D Issue Fee
`D A check in the amount of the fee(s) is enclosed.
`C1 Publication Fee (No small entity discount permitted)
`C1 Payment by credit card. Form PTO-2038 is attached.
`
`ayment, to
`D The Director is hereby authorized by charge die required fee(s), or credit any ove
`1:1 Advance Order - # of Copies
`Deposrt Account Number
`(enclose an extra copy of this form .
`—_——______—____—__——————————
`5. Change in Entity Status (from status indicated above)
`1:1 b. Applicant is no longer claiming SMALL ENTITY status. See 37 CFR 1.27(g)(2).
`0 a. Applicant claims SMALL ENTITY status. See 37 CFR 1.27.
`The Director of the USPTO is requested to apply the Issue Fee and Publication Fee (ifany) or to re-a ply any previously paid issue fee to the application identified above.
`NOTE: The Issue Fee and Publication Fee (i
`required) Will not be accepted from anyone other than
`e 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.
`
`Date
`
`Registration No.
`Typed or printed name
`__—_—________________——————————
`This collection ofinformation is required by 37 CFR 1.31 l. The information is refipired to obtain or retain a benefit b§ 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.
`.15 collection is estimated to take 1 minutes to complete, including gathering, preparing, and
`submitting the completed application form to the USPTO. Time Will vary dcepending upon. the individual case. Any comments on the amount of time you require to complete
`this form and/or su gestions for reducing this burden, should be sent to
`e
`ref In ormation Officer, US. Patent and Trademark Office, U_.S_. Department of Commerce,
`.0.
`Box 1450, Alexan na, Vir inia 22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commrssroner for Patents, PO. Box 1450,
`Alexandria, Virginia 2231 -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.
`
`Authorized Signature
`
`PTOL-85 (Rev. 12/04) Approved for use through 04/30/2007.
`
`OMB 0651—0033
`
`US. Patent and Trademark Office; US. DEPARTMENT OF COMMERCE
`
`

`

`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`[0.3011 1450
`Alexandria. Virginia 22313-1450
`www.115pto.gov
`
`10/158,216
`
`05/31/2002
`
`John R. Plachetka
`
`7569/73281
`
`5014
`
`Michael A Sanzo
`Fitch Even Tabin & Flannery
`1801 K Street NW Suite 4011
`Washinton, DC 20006-1201
`
`SPEAK. JAMES M
`
`1615
`DATE MAILED: 03/29/2005
`
`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 273 day(s). If the issue fee is paid 'on the date that is three months afier 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 273 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-SS (Rev. 12/04) Approved for use through 04/30/2007.
`
`Page 3 of 3
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`Notice of Allowability
`
`Application No.
`
`Applicant(s)
`
`10/158 216
`Examiner
`
`PLACHETKA, JOHN R
`Art Unit
`
`James M Spear
`
`1615
`
`
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address--
`All cIaims 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. E This communication is responsive to The Request for Continued Examination and Amendment filed 11/22/2004.
`
`2. E The allowed claim(s) is/are 1-50 and 53—57.
`
`3.
`
`The drawings filed on 31 May 2002 are accepted by the Examiner.
`
`4. El Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`a) [I All
`b) C] Some‘
`c) E] None
`of the:
`
`1. El Certified copies of the priority documents have been received.
`
`2. El Certified copies of the priority documents have been received in Application No.
`
`
`
`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(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 resultIn ABANDONMENT of this application.
`THIS THREE-MONTH PERIOD IS NOT EXTENDABLE.
`
`
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`5. [I A SUBSTITUTE OATH OR DECLARATION must be submitted. Note the attached EXAMINER'S AMENDMENT or NOTICE OF
`INFORMAL PATENT APPLICATION (PTO-152) which gives reason(s) why the oath or declaration is deficient.
`
`6. El CORRECTED DRAWINGS ( as "replacement sheets”) must be submitted.
`
`(a) El including changes required by the Notice of Draftsperson's Patent Drawing Review( PTO-948) attached
`
`1) C] hereto or 2) D to Paper No./Mai| Date
`
`(b) El including changes required by the attached Examiner’s Amendment / Comment or in the Office action of
`
`Paper No./Mail Date
`
`Identifying indicia such as the application number (see 37 CFR 1.84(c)) should be written on the drawings in the front (not the back) of
`each sheet. Replacement sheet(s) should be labeled as such In the header according to 37 CFR 1.121(d).
`
`7. D 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. [I Notice of References Cited (PTO-892)
`
`
`
`
`5. [:1 Notice of Informal Patent Application (PTO-152)
`
`2. E] Notice of Draftperson's Patent Drawing Review (PTO-948)
`
`3. [:1 Information Disclosure Statements (PTO-1449 or PTO/SB/OB),
`Paper No./Mai| Date
`4. El Examiner's Comment Regarding Requirement for Deposit
`
`of Biological Material
`
`6. E] Interview Summary (PTO-413),
`Paper No./MaiI Date
`.
`7. E] Examiner's Amendment/Comment
`
`8. IX Examiner's Statement of Reasons for Allowance
`
`9. C] Other____
`
`
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`T
`.
`flat/(p/s’
`I
`PTOL-37 (Rev. 1-04)
`Part of Paper No./Mai| Date 032020»
`Notice of Allowability
`.
`
`PRIMARY EXAMINER
`
`JAMES M. SPEAR
`
`——2
`
`

`

`Application/Control Number: 10/158,216
`
`Page 2
`
`Art Unit: 1615
`
`1.
`
`2.
`
`The following is an examiner’s statement of reasons for allowance:
`
`Applicant shows a unit dose form of an acid inhibitor and a non-
`
`steroidal anti-inflammatory drug ( NSAID) formulated to provide
`
`coordinated release of said drugs. Combinations of such drugs are known.
`
`Goldman et al US 5,204,118 and Depui et al US 6,613,354 82, considered
`
`the closest prior art of record show combinations of such drugs. The prior
`
`art does not show nor fairly suggest the particular combination wherein said
`
`NSAID is incorporated in the dosage form such that it is surrounded by a
`
`coating that upon ingestion of said unit dosage form by a patient prevents
`
`the release of essentially any NSAID from said dosage form unless the ph
`
`of the surrounding medium is 3.5 or higher and at least a portion of said
`
`acid inhibitor is not surrounded by an enteric coating and upon ingestion of
`
`said unit dosage form by a patient is released regardless of whether the ph
`
`of the surrounding medium is below 3.5 or above 3.5. This relationship
`
`between ph and drug delivery enables more safe delivery of the active
`
`agents than previous dosage forms.
`
`Any comments considered necessary by applicant must be submitted
`
`no later than the payment of the issue fee and, to avoid processing delays,
`
`

`

`Application/Control Number: 10/158,216
`Art Unit: 1615
`
`Page 3 ‘
`
`should preferably accompany the issue fee. Such submissions should be
`
`clearly labeled “Comments on Statement of Reasons for Allowance.”
`
`Claims 1-50 and 53-57 are allowed.
`
`Claims 51 and 52 have been canceled.
`
`Any inquiry concerning this communication or earlier communications
`
`from the examiner should be directed to James M Spear whose telephone
`
`number is 571 272 0605. The examiner can normally be reached on
`
`Monday thru Friday from 6:30 AM to 3 PM.
`
`If attempts to reach the examiner by telephone are unsuccessful, the
`
`examiner's supervisor, Thurman K Page, can be reached on 571 272 0602.
`
`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
`
`

`

`Application/Control Number: 10/158,216
`
`Page 4
`
`Art Unit: 1615
`
`system, see http://pair—direct.uspto.gov. Should you have questions on
`
`access to the Private PAIR system, contact the Electronic Business Center
`
`(EBC) at866-217-9197 (toll-free). W
`
`James M Spear
`Primary Examiner
`Art Unit 1615
`
`March 20, 2005
`
`