Page 1 of 1
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`UNITED STATES DEPARTDIENT OF COMMERCE
`United States Patent and Trademark Office
`.
`.
`4 0
`Address: CO1\‘IVIIlS§ION'ER FOR PATENTS
`cXEI:I‘I‘in, Vugmn 22313-I450
`www.uspto.gov
`
`APPLICATION NUMBER
`
`FILING OR 371 (c) DATE
`
`FIRST NAMED APPLICANT
`
`A'I'l'Y. DOCKET NO./TITLE
`
`10/129,773
`
`08/28/2002
`
`Alan Roy Deam
`
`Z706l7-[US
`
`44992ASTRAZENECA M, BOSTON
`
`35 GATEHOUSE DRIVE
`WALTHAM, MA 02451-1215
`
`CONFIRMATION NO. 7672
`
`*lc|)llr|3l(|)lllllltllcllllllllllllgllilllllllll||l||l|||ll|llllllllllllllllllllllll
`
`Date Mailed: 07/31/2006
`
`NOTICE OF ACCEPTANCE OF POWER OF ATTORNEY
`
`This is in response to the Power of Attorney filed 07/17/2006.
`
`The Power of Attorney in this application is accepted. Correspondence in this application will be mailed to the
`above address as provided by 37 CFR 1.33.
`
`MELK/flM BEYENE
`PTOSS (703) 305-3006
`
`OFFICE COPY
`
`   
`


`
`Lannett Holdings, Inc. LAN 1002
`
`

`
`
`
`Page 1 of 1
`
`UNITED STATES DEPARTMENT OF COMIVIERCE
`United States Patent and Trudemurk Office
`Address: COMMISSIONER FOR PATENTS
`P.0. Box I450
`Alexandria, Virginia 22313-1450
`www.us'plo.gov
`
`APPLICATION NUMBER
`
`FILING OR 371 (c) DATE
`
`FIRST NAMED APPLICANT
`
`ATTY. DOCKET NOfI‘ITLE
`
`10/129,773
`
`08/28/2002
`
`Alan Roy Deam
`
`ASZD-P01-617
`
`28120
`8:
`
`G
`
`ONE INTERNATIONAL PLACE
`BOSTON, MA 02110-2624
`
`CONFIRMATION No. 7672
`IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII
`.
`OC000000019826775
`
`.
`
`Date Mailed: 07/31/2006
`
`NOTICE REGARDING CHANGE OF POWER OF ATTORNEY
`
`This is in response to the Power of Attorney filed 07/17/2006.
`
`o The Power of Attorney to you in this application has been revoked by the assignee who has intervened as
`provided by 37 CFR 3.71. Future correspondence will be mailed to the new address of record(37 CFR 1.33).
`
`dgggiavé g
`MELK M BEYENE
`PTOSS (703) 305-3006
`
`OFFICE COPY
`
`

`
`
`
`rr
`I
`
`
`
`PTOISBIEZ (04-05)
`Approved for use through 11r3o/zoos. OMB 0651-0035
`u.s. Patent and Trademark Olfice: U.S. DEPARTMENT OF COMMERCE
`-- toaocl|ectionofinforrr1ationunlessltd'
`- -avaid OMBcont:ol mmber.
`
`
`
`A o lication Number
`
`
`
`1 0/1 29773
`Au ust 28. 2002
`
`REVOCATION OF POWER OF
`
`
`New :g;,<;:~§:x",';gRNE,
`
`
`AND
`
`
`
`CHANGE OF CORRESPONDENCE ADDRESS
`
`Notvemssined
`
`270617-ms
`
`
`
`‘:1 A Power of Attorney is submitted herewith.
`OR
`
`I hereby revoke all previous powers of attorney given in the above-identified application.
`
`
`
`44992
`'2] I hereby appoint the practitioners associated with the Customer Number:
`
`
`
`
`
`Please change the correspondence address for the above-identified application to:
`The address associated with
`Customer Number.
`
`
`44992
`
`t
`
`OR
`
`
`
`Astrazeneca Pharmaceuticals LP
`Address Global Intellectual Property
`35 Gatehouse Drive
`
`
`
`E 02451
`(781)839-4000 @
`
`
`l am the:
`
`
`
`El Applicant/Inventor.
` E] Assignee of record of the entire interest. See 37 CFR 3.71.
`
`
`L110 Telephone
`
`SIG in URE of
`n or Assignee of Record
`—’w *5’
`
`
`
`44 (0)1625 512461
`
`
`
`I hereby certify that this correspondence is being deposited with the U.S. Postal Service with sufficient postage as First Class Mail, in
`an envelope addressed to: MS Post Issue. Commissioner for Patents. PO. Box 1450. Alexandria, VA 22313-1450. on the date shown
`below.
`
`Dated:
`
`Statement under 37 CFR 3. 73(b) is enclosed.
`
`(Form PTO/SB/96)
`
`

`
`
`
`PTOISBISG (0904)
`Approved for use through 07/31I2006. OMB 0651-0031
`U.S. Patent and Trademark Offlcez U.S. DEPARTMENT OF COMMERCE
`ulredtnres - toaouflectbnofi-dom1ationunlessitd'
`avalidOMBcontmlnumber.
`
`
`STATEMENT UNDER 37 CFR 3.73(b)
`
`Applicant/Patent Owner:
`
`Dearn et al.
`
`Application NoJPatent No.:
`
`6750237
`
`Filed/Issue Date:
`
`June 15, 2006
`
`Entitled:
`
`PHARMACEUTICAL FORMULATIONS CONTAINING ZOLMITRIPTAN
`
`Astrazeneca AB
`(Name of Asslgneo)
`
`. a
`
`ration
`Cor
`(Type of Assignee. e.g.. corporation. partnership. university. government agency. etc.)
`
`states that it is:
`
`1.
`
`[:1 the assignee of the entire right. title. and interest; or
`
`2. E] an assignee of less than the entire right. title and interest.
`The extent (by percentage) of its ownership interest is
`in the patent application/patent identified above by virtue of either:
`
`%
`
`A. I3 An assignment from the inventor(s) of the patent application/patent identified above. The assignment
`was recorded in the United States Patent and Trademark Office at Reel
`012996
`,
`Frame
`0425
`. or for which a copy thereof is attached.
`
`OR
`
`B_ D A chain of title from the inventor(s). of the patent applicationlpatent identified above, to the current
`assignee as shown below:
`1. From:
`To:
`The document was recorded in the United States Patent and Trademark Office at
`Reel
`. Frame
`. or for which a copy thereof is attached.
`
`To:
`2. From:
`The document was recorded in the United States Patent and Trademark Office at
`Reel
`. Frame
`. or for which a copy thereof is attached.
`
`To:
`3. From:
`The document was recorded in the United States Patent and Trademark Office at
`Reel
`, Frame
`, or for which a copy thereof is attached.
`
`CI Additional documents in the chain of title are listed on a supplemental sheet.
`
`D Copies of assignments or other documents in the chain of title are attached.
`[NOTE: A separate copy (i.e., a true copy of the original assignment document(s)) must be
`submitted to Assignment Division in accordance with 37 CFR Part 3, if the assignment is to be
`recorded in the records of the USPTO. & MPEP 302.08]
`rized to act on behalf of the assig nee.
`
`
`
`Kevin Bill
`Printed or Typed Name
`Authorized Si ner for Assi nee
`Title
`
`+44 (0)1625 512461
`Telephone Number
`
`I hereby certify that this correspondence is being deposited with the US. Postal Service with sufficient postage as First Class Mail. in
`an envelope addressed to: MS Post Issue. Commissioner for Patents. PO. Box 1450. Alexandria. VA 22313-1450. on the date shown
`below.
`
`Dated:
`
`'/ flé
`
`/ M44/'4 fr
`
`

`
`TTAL O
`PARTB-FEES TRAN
`-
`‘
`'
`'
`'
`SMI
`.
`()
`O”,
`
`g rid this form, together with applicable fee(s), to: Mail Mail Stop ISSUE FEE
`Complete
`Commissioner for Patents
`P.0. Box 1450
`Alexandria, Virginia 22313-1450
`or 17.82‘
`(703) 746-4000
`through 4 should be completed where
`is form should be used_for transmitting the ISSUE FEE and PUBLICATION FEE (if required . Blocks I
`rther correspondence including the Patent, advance orders aridnotification of maintenance fees will
`mailed to the current corres ondence address as
`=
`-
`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 (N°"‘ ugibly '"‘""'“P ‘M’ “V °°"°°‘i°“‘ °”‘s‘ E'°°" ')
`
`28120
`
`7590
`
`02/27/2004
`
`ROPES & GRAY LLP
`ONE INTERNATIONAL PLACE
`BOSTON, MA 02110-2624
`
`Note: A certificate of mailin can only be used for domestic mailings of the
`Fee(s) Transmittal. This cei-ti icate cannot be used for any other accompanying
`papers. Each additional paper, _such as an assignment or fomial drawing, must
`ave its own certificate of mailing or transmission.
`
`Certificate of Mailing or Transmission
`that this Fe
`s Transmittal is being deposited with the U 't d
`Ihereb certi
`ervice with sfi(flicient postage for first class mail in an envello;c)e
`States ostal
`addressed to the Mail Stop ISSUE FEE address above, or being facsimile
`transmitted to the USPTO, on the date indicated below.
`
`APPLICATION NO.
`
`FILING DATE
`
`W- ,
`
`Ar1l
`FIRST NAMED INVENTOR
`
`’
`"-' 2004
`ATTORNEY DOCKET NO.
`
`(Date)
`CONFIRMATION N0.
`
`Alan Roy Deam
`08/28/2002
`l0/129,773
`TITLE OF INVENTION: PHARMACEUTICAL FORMULATIONS CONTAINING ZOLMITRIPTAN
`
`ASZD-P01-617
`
`7672
`
`APPLN. TYPE
`
`SMALL ENTITY
`
`nonprovisional
`
`NO
`
`ISSUE FEE
`
`S1330
`
`PUBLICATION FEE
`
`TOTAL FEE(S) DUE
`
`‘ DATE DUE
`
`$0
`
`S I 330
`
`05/27/2004
`
`PRYOR, ALTON NATHANIEL
`
`1616
`
`' 514-376000
`
`I
`
`1. Chan e of correspondence address or indication of "Fee Address" (37
`CFR L 63)‘
`El Change of corres ondence address (or Change of Correspondence
`Address foirn PTO B/122) attached.
`El "Fee Address" indication (or "Fee Address“ Indication foirn
`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 (I) the
`names of up to 3 registered patent attorneys 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.
`
`3. ASSIGNEE NAME AND RESIDENCE DATA TO BE PRINTED ON THE PATENT (print or type)
`
`1 Ropes & Gray LL}?
`'
`
`'
`
`2
`
`3
`
`PLEASE NOTE: Unless an assi%ee is identified below, no assignee data will appear on the_ patent. Inclusion of assignee data is on] appropriate when an assignment has
`been previously submitted to the SPTO or is being submitted under separate cover. Completion of this form is NOT a substitute for fi ing an assignment.
`(A) NAME OF ASSIGNEE
`'
`(B) RESIDENCE: (CITY and STATE OR COUNTRY)
`
`As trazeneca AB
`
`London, United Kingdom
`
`
`
`Cl individual Mfcorporation or other private group entityPlease check the appropriate assignee category or categories (will not be printed on the patent); Cl government
`
`4a. The following fee(s) are enclosed:
`4b. Payment of Fee(s):
`W Issue Fee
`Cl A check in the amount of the fee(s) is enclosed.
`0 Publication Fee
`Cl Payment by credit card. Form PTO-2038 is attached. '
`
`N Advance Order - # of Copies
`
`ayment, to
`E The_ Director is hereby authorized by c arge the required fee(s), or credit any ove
`Deposit Account Number
`- »
`(enclose an extra copy of this forrhg.
`Director for Patents 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.
`
`].Q
`
`(Date)
`(Azed Signature {
`.
`2004
`Aril 29
`r -r
`/ z -ié-r
`"NOTE; T_lie Issue Fee and Publication Fee (if required) will not be accepted from anyor_ie$
`?.l{L°r'es‘:"a“.i,‘sl.'I§é’.”§’§'fi?2?e3o§?i§'§i°ii§’é'i?.ll?§3‘°§ia‘§és° §t'é§i:ZLJ‘i9m’.i‘§$.i§'5if6’r'a22l'°' "my "‘f
`This collection of information is re uired by 37 CFR l.3ll. The information is required to ‘
`obtain or retain a benefit by the pu lic which is to file (and b the USPTO to process) an
`application. Confidentiality is governed by 35 U.$.C. 122 and 3 CFR_l.l4. This collection is
`estimated to tak_e l_2 minutes to com lete, including gathering, preparing, and submitting the
`completed application form to the
`SPTO._ Time will vary dependin upon the individual
`case. Any comments. on the amount of time you require to_ com? etc this fonn and/or
`suggestions for reducing this burden, should be sent to the Chief In ormation Officer, U.S.
`Patent and Trademark Office, U.S. Department of Commerce, Alexandria, Vir inia
`22313-I450. DO.NOT SEND FEES OR COMPLETED FORMS TO THIS ADD
`SS.
`SEND TO: Commissioner for Patents, Alexandria, Virginia 22313-1450.
`
`4
`05/05/200‘ MHHEDB 00000088 1819 5
`01 FC:1501
`1330.00 09
`02 FC:0001
`30.00 00
`
`10129773
`
`Under_the Papenivorlt Reduction Act of 1995, nqvfgersons are required to respond to a
`collection of information unless it displays a valid 0
`control number.
`TRANSMIT THIS FORM WITH FEE(S)
`
`PTOL-85 (Rev. ll/03) Approved for use through 04/30/2004.
`
`OMB 0651-0033
`
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`
`

`
` UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Oflice
`Address: COMMISSIONER FOR PATENTS
`PO. Box I450 _
`Alexandria, Virginia 22JI J-I450
`www.usptn.gov
`
`NOTICE OF ALLOWANCE AND FEE(S) DUE
`
`ROPES & GRAY LLP
`ONE INTERNATIONAL PLACE
`BOSTON, MA 02110-2624
`
`PRYOR, ALTON NATHANIEL
`
`I616
`
`DATE MAILED: 02/27/2004
`
`FIRST NAMED INVENTOR
`Alan Roy Deam
`08/28/2002
`10/129,773
`TITLE OF INVENTION: PHARMACEUTICAL FORMULATIONS CONTAINING ZOLMITRIPTAN
`
`ATTORNEY DOCKET NO.
`AszD-P01-617
`
`CONFIRMATION No.
`7672
`
`APPLN. TYPE
`
`SMALL ENTITY
`
`nonprovisional
`
`NO
`
`ISSUE FEE
`
`$1330
`
`PUBLICATION FEE
`
`TOTAL FEE(S) DUE
`
`$0
`
`$1330
`
`DATE DUE
`
`05/27/2004
`
`THE APPLICATION IDENTIFIED ABOVE HAS BEEN EXAMINED AND IS ALLOWED FOR ISSUANCE AS A PATENT.
` QN QN IHE MEETS IS . 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.
`
`THE ISSUE FEE AND PUBLICATION FEE (IF REQUIRED) MUST BE PAID WITHIN IIEE MQN'_Ifl§ FROM THE
`MAILING DATE OF THIS NOTICE OR THIS APPLICATION SHALL BE REGARDED AS ABANDONED.
`THIS
` RY PERIOD QANN_Q'_I'_ flil . 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-85B (OR
`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:
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`If the SMALL ENTITY is shown as NO:
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`A. If the status is the same, pay the TOTAL FEE(S) DUE shown
`above.
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`A. Pay TOTAL FEE(S) DUE shown above, or
`
`B. If the status is changed, pay the PUBLICATION FEE (if
`required) and twice the amount of the ISSUE FEE shown above
`and notify the United States Patent and Trademark Office of the
`change in Status’ or
`
`B. If applicant claimed SMALL ENTITY status before, or is now
`claiming SMALL ENTITY status, check the box below and enclose
`the PUBLICATION FEE and 1/2 the ISSUE FEE shown above.
`D Applicant claims SMALL ENTITY status.
`See 37 CFR 1.27.
`
`II. 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
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`
`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. ll/03) Approved for use through 04/30/2004.
`
`Page I of 3
`
`

`
`PART B - FEE(S) TRANSMITTAL
`
`Complete and send this form, together with applicable fee(s), to: Maj] Mail Stop ISSUE FEE
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`or M (703) 746-4000
`
`through 4 should be completed where
`INSTRUCTIONS: This form should be. used_for transmitting the ISSUE FEE and ‘PUBLICATION FEE (if required)).eBlocks 1
`ap ropriate. All further correspondence including the Patent, advance orders al_‘ld.Il0ilI'lCall0l’l of maintenance fees will
`mai|e_d to the current corres ondence address as
`in icated unless corrected below or directed otherwise in Block I, by (a) specifying a new correspondence address; and/or (b) indicating a separate " EE ADDRESS" for
`
`maintenance fee notifications.
`
`CURRENT CORRESPONDENCE ADDRESS (Note: Legibly mark-up with any corrections oruse Block 1)
`
`23120
`
`7590
`
`02/27/2004
`
`ROPES & GRAY LLP
`ONE INTERNATIONAL PLACE
`BOSTON, MA 02110-2624
`
`can only be used for domestic mailings of the
`Note: A certificate of mam"
`Fee(s) Transmittal. This certi icate cannot be used for any other accompanying
`papers. Each additional paper, such as an assignment or fonnal drawing, must
`ave its own certificate of mailing or transmission.
`
`Certificate of Mailing or Transmission
`that this Fee s Transmittal is bein de osited with the United
`I hereb certi
`ervice with sullicient postage for fir§t clgss mail in an envelope
`States ostal
`addressed to the Mail Stop ISSUE FEE address above, or being facsimile
`transmitted to the USPTO, on the date indicated below.
`
`
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`Alan Roy Deam
`08/28/2002
`10/ 129,773
`TITLE OF INVENTION: PHARMACEUTICAL FORMULATIONS CONTAINING ZOLMITRIPTAN
`
`ASZD-P01-617
`
`7672
`
`nonprovisional
`
`N0
`
`PRYOR, ALTON NATHANIEL
`
`$1330
`
`1616
`
`$0
`
`$1330
`
`05/27/2004
`
`514-376000
`
`1. Chan e of correspondence address or indication of "Fee Address" (37
`CFR 1- 63).
`Cl Change of corres ondence address (or Change of Correspondence
`Address form PTO B/122) attached.
`D "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 (I) the
`names of up to 3 registered patent attorneys 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.
`
`1
`
`2
`
`3
`
`3. ASSIGNEE NAME AND RESIDENCE DATA TO BE PRINTED ON THE PATENT (print or type)
`
`PLEASE NOTE: Unless an assi%ee is identified below, no assignee data will appear on the patent. Inclusion of assignee data is onl appropriate when an assignment has
`been previously submitted to the SPTO or is being submitted under separate cover. Completion of this fonn is NOT a substitute for fi ing 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);
`El individual
`El corporation or other private group entity
`El government
`4a. The following fee(s) are enclosed:
`4b. Payment of Fee(s):
`Cl Issue Fee
`Cl A check in the amount of the fee(s) is enclosed.
`Cl Publication Fee
`CI Payment by credit card. FOI111 PTO-2038 is attached.
`
`Cl Advance Order - # of Copies
`
`ayment, to
`CI The Director is hereby authorized by charge the required fee(s), or credit any ove
`Deposit Account Number
`(enclose an extra copy of this form .
`
`Director for Patents 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.
`
`(Authorized Signature)
`
`
`
`
`
`NOTE; The Issue Fee and Publication Fee (if required) will not be accepted from anyone
`
`other than the applicant; a registered attome
`or a ent; or the assignee or other party in
`interest as shown y the records of the United States
`atent and Trademark Office.
`This collection of infonnation is re uired by 37 CFR 1.311. The information is required to
`obtain or retain a benefit by the pu lic which is to file (and b the USPTO to process) an
`application. Confidentiality is governed by _35 U.S.C. 122 and 3 CFR.l.l4. This collection is
`estimated to take 12 minutes to com lete, including gathering, preparing, and submitting the
`completed application form to the
`SPTO._ Time will vary depending upon the individual
`case. Any comments on the amount of time you require to com etc this fonn and/or
`suggestions for reducing this burden, should be sent to the Chief In orrnation Officer, U.S.
`Patent and Trademark Office, U.S. Department of Commerce, Alexandria, Vir inia
`22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADD SS.
`SEND TO: Commissioner for Patents, Alexandria, Virgima 22313-1450.
`
`
`
`Underlthe Paperworlg Reduction Act of 1995, nqvfgersons are required to respond to a
`collection of infonnation unless it displays a valid 0
`control number.
`
`
`TRANSMIT THIS FORM WITH FEE(S)
`
`PTOL-85 (Rev. 1 1/03) Approved for use through 04/30/2004.
`
`OMB 0651-0033
`
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`
`

`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box I450
`Alexandria. Virginia 223 I3-I450
`www.usp\o.gov
`
`APPLICATION NO,
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`I0/129,773
`
`08/28/2002
`
`Alan Roy Deam
`
`ASZD-POI-617
`
`-
`
`7672
`
`ROPES & GRAY LLP
`
`ONE INTERNATIONAL PLACE
`BOSTON, MA 02110-2624
`
`A
`
`PRYOR, ALTON NATHANIEL
`
`1616
`
`DATE MAILED: 02/27/2004
`
`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) system (http://pair.uspto. gov).
`A
`
`Any questions regarding the Patent Term Extension or Adjustment determination should be directed to the Office of
`Patent Legal Administration at (703) 305-1383. 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. I I/03) Approved for use through 04/30/2004.
`
`Page 3 of 3
`
`

`
`_
`_
`_
`Notice of Allowability
`
`10/129,773
`Examine,
`
`DEARN ET AL.
`A” Unit
`
`Application No.
`
`Applicant(s)
`
`Alton N. Pryor
`
`1616 ~
`
`-- The MAILING DATE 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. I; This communication is responsive to 11/28/03.
`
`2. E] The allowed claim(s) is/are 1-12 15 16 18,21 (claims renumbered 1-16).
`
`3. E] The drawings filed on
`
`are accepted by the Examiner.
`
`4. E] Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`
`a) [I All
`
`b) I] Some‘
`
`c) C] None
`
`ofthe:
`
`1. C] Certified copies of the priority documents have been received.
`
`2. El Certified copies of the priority documents have been received in Application No. j
`
`3. Cl Copies ofthe 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.
`
`r
`
`5. E] A SUBSTITUTE OATH OR DECLARATION must be submitted. Note the attached EXAM|NER’S AMENDMENT or NOTICE OF
`INFORMAL PATENT APPLICATION (PTO-152) which gives reason(s) why the oath or declaration is deficient.
`
`6. D 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) 1:] hereto or 2) D to Paper No./Mail Date __
`
`(b) [:1 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. E] 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. E] Notice of References Cited (PTO-892)
`
`-
`5. E] Notice of Informal Patent Application (PTO-152)
`
`2. [3 Notice of Draftperson's Patent Drawing Review (PTO-948)
`
`3. [:1 Information Disclosure Statements (PTO-1449 or PTO/SB/08),
`Paper No./Mail Date
`4. El Examiner's Comment Regarding Requirement for Deposit
`
`6. [3 Interview Summary (PTO-413),
`Paper No./Mail Date
`.
`7. E Examiner's Amendment/Comment
`
`8. E Examiner's Statement of Reasons forAlIowance
`
`of Biological Material
`
`9. C] Other
`
`.
`
`U.S. Patent and Trademark Office
`
`PTOL-37 (Rev. 1-04)
`
`Notice of Allowability
`
`Part of Paper No./Mail Date 022004
`
`

`
`Application/Control Number: 10/129,773
`
`Page 2
`
`Art Unit: 1616
`
`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 Attorney Halstead on 2/20/04.
`
`The application has been amended as follows:
`
`a)
`
`in claim 15 line 2 delete “and” and insert --- or ---.
`
`The following is an examiner’s statement of reasons for allowance: The prior art
`
`does not teach _or suggest a composition comprising zolmitriptan existing in a pH
`
`ranging from 4.5 to 5.5.
`
`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.”
`
`Telephonic Inquiry
`
`Any inouiry concerning this communication or earlier communications from the
`
`examiner should be directed to Alton N. Pryor whose telephone number is 571-272-
`
`0621. The examiner can normally be reached on 8:00 a.m. — 4:30 p.m..
`
`lf attempts to reach the examiner by telephone are unsuccessful, the examiner’s
`
`supervisor, Thurman Page can be reached on 571-272-0612. The fax phonenumber
`
`for the organization where this application or proceeding is assigned is 703-872-9306.
`
`

`
`Application/Control Number: 10/129773
`
`Page 3
`
`Art Unit: 1616
`
`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 (to||-free).
`
`/U/I5§3vvN.pnvon
` Alton Pry
`
`IM. RY EXAMINER
`Primary Examiner
`AU 1616
`
`

`
`Issue Classification
`
`.m.PA
`
`0.Nn.mm.n|.
`
`10/129,773
`Examiner
`
`Alton N. Pryor
`
`App|icant(s)
`
`DEARN ET AL.
`
`E] Claims renumbered in the same order as presented by applicant
`
`C
`
`D_£__u_
`
`-
`
`023456780234560
`
`27
`28
`29
`
`
`
`
`
`3333333344444444555555555
`
`
`
`
`
`2345678912345679012345789
`
`666667777777777888888
`
`2345701234567891235-/8
`
`103
`104
`105
`
`
`
`nnmmmmflflmE111111..nHH..uHHHHH..n.Q
`
`T.
`
`D.2:
`
`126
`
`4|4|4|a|a|4|4|4l4|4I4I.4|4|4|4|a|n|a|4l1r4|4|..|a|_NC__LO22222222333333333344444444445M411111
`
`
`
`
`G123457890123456-/8901234567890
`
`U R.1.47
`
`
`
`88888999999919856789012345690123456780_NC_@CO90000000001141111111111112222222222
`
`197
`
`181
`182
`183
`184
`
`
`
`
`
`
`EC
`E»
`O
`
`151
`152
`153
`154
`155
`
`111111111111%55556666666 f678901234569012345678900677777777778nD.11111111111
`
`
`167
`168
`
`
`
`
`
`
`
`U.S. Patent and Trademark Office
`
`Paper No. 022004
`
`
`
`
`
`
`

`
`Index of Claims
`
`Application No.
`
`Applicant(s)
`
`10/129,773
`Examiner
`
`Alton N. Pryor
`
`DEARN ET AL.
`
`(Through numeral)
`Cancelled
`
`Restricted
`
`m Non-Elected
`H
`
`N Appeal
`E Objected
`
`
`
`IHIBEIIIIIIII
`IEIIEEIIIIIIII
`1,---------
`ILJIEEIIIIIIII
`ZIHIIIIIIIII
`
`EfifififififiIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII
`
`K---------
`Z---------
`Z---------
`IIIIIIIIII
`ZEIIIIIIIIII
`K---------
`----------
`
`
`
`
`
`EfifififififififififlfifififiIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIEIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII
`
`IIIIIIIIII
`2---------
`ZIIIIIIIII
`ZIEIIIIIIIII
`-E-------K
`—-----I---
`1E!-----I---
`IE-------K
`I...-1
`
`EEHHHHHHHHIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII
`lD®\lO5U'1-bhlk)
`
`--
`—-----I---
`------I---
`2---------
`IEEIIIIIIIII
`IEEIIIIIIIII
`ZIIIIIIIII
`_---------
`IIEIIIIIIIII
`ZEIIIIIIIIII
`JEIIIIIIIIII
`2---------
`3
`
`_________e-_88§338'$.’B£B'5’1:‘IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII
`
`_..a._n..n..na
`
`(.n)00(d(a)(.A)(.a)O')U'l-h(A)l\)A
`
`U.S. Patent and Trademark Office
`
`Part of Paper No. 022004
`
`

`
`
`
`Search Notes
`
`Application No.
`
`App|icant(s)
`
`10/129,773
`Examiner
`
`DEARN ET AL.
`Art Unit
`
`Alton N. Pryor
`
`1616
`
`
`
`
`
`
`
`
`
`
`
`
`.
`
`SEARCH NOTES
`
`(INCLUDING SEARCH STRATEGY)
`
`SEARCHED
`
`376
`
`2/19/2004
`
`AN P
`
`122
`
`2/20/2004
`
`ANP
`
`514
`
`548
`
`
`
` INTERFERENCE SEARCHED
`
`
`
`U.S. Patent and Trademark Office
`
`Part of Paper No. 022004
`
`

`
`"In the claims:
`
`For the convenience of the Examiner, all claims being examined, whether or not
`
`amended, are presented below.
`
`1. (Currently Amended) A pharmaceutical formulation suitable for intranasal administration
`
`which comprises zolmitriptan and a pharmaceutically acceptable carrier wherein the pH of the
`
`formulation is
`
`in the range 4.5 to 5.5.
`
`2. (Currently Amended) A pharmaceutical formulation according to claim 1, wherein the pH of
`
`the formulation is
`
`L
`
`3. (Previously Presented) A pharmaceutical formulation according to claim 1 wherein the
`
`formulation is buffered.
`
`4. (Previously Presented) A pharmaceutical formulation according to claim 2 wherein the
`
`formulation is buffered.
`
`E (Currently Amended)
`
`A pharmaceutical
`
`tan and a
`formulation suitable.for intranasal administration which com rises zolmitri
`
`
`pharmaceutically acceptable carrier wherein the pH of the formulation is less than 7.0, wherein
`
`
`the formulation is buffered b w-l=ierein—the~bu~ffer-is a mixture of citric acid and disodium
`
`phosphate.
`
`till
`/6? (Currently Amended)
`
`5
`
`A pharmaceutical
`
`tan and a
`fonnulation suitable for intranasal administration which com rises zolmitri
`
`
`pharmaceutically acceptable carrier wherein the pH of the formulation is in the range 4.5 to 5.5,
`
`wherein the formulation is buffered by wherein-the-bu£fer—is a mixture of citric acid and
`
`disodium phosphate.
`
`K
`,7.’(Previously Presented) A pharmaceutical formulation according to claim I which is sterile.
`
`L,
`
`/8.’(Previously Presented) A pharmaceutical formulation according to claim 2 which is sterile.
`
`

`
`‘P
`g9.’ (Previously Presented) A pharmaceutical formulation according to claim 3 which is sterile.
`
`*8
`/l6. (Previously Presented) A phannaceutical formulation according to claim 4 which is sterile.
`
`Q~
`L0
`,l’l’. (Previously Presented) A pharmaceutical formulation according to claim/which is sterile.
`1
`:i
`'
`,117f(Previously Presented) A phannaceutical fonnulatian’according to claim%rhich is sterile.
`
`13. (Cancelled) A process for preparing a sterile pharmaceutical formulation as defined in any
`
`one of claims 7-12 which comprises autoclaving.
`
`14. (Cancelled) A method oftreating a disease condition wherein agonjsm of SHTI -receptors is
`beneficial which comprises administering an effective amount of a pharmaceutical formulation
`
`as defined in any one of claims 1 to 12.
`
`|%>'.(CurrentlyAmended) Anintranasaladministrationdevicficontainingaphamiaceutical
`formulation as defined in any one ofclaims l[to 12], 2,QZ and Q.
`.
`\ 3
`/‘hf(Currently Amended)" An IE intranasal administration device ofclaim Lé, wherein the
`
`‘
`
`'
`
`pharmaceutical formulation
`
`packaged to
`
`_ provide protectiea the forrnulation from light.
`
`.
`
`'
`
`s 17. (Cancelled)
`I5
`28? (Currently Amended) An aqueous solution of zolmitriptan in a buffer at a pH in the range o_f ‘
`4.5 to 5.5.
`
`19. (Cancelled)
`
`20. (Cancelled)
`
`

`
`\5
`IL
`21.7(New) The aqueous solfition ofclaim)8: wherein the pH is 5.
`
`

`
`wo orr39'i72
`
`.
`
`_l_
`
`a-r2.2..ag:r:-'-'3f.@gF§g%3
`PCTIGB00/04528
`JD13 Rec’d PCT/PTO 0 9 my 2392
`PHAIUUKCEUTIQAL FORMULATIONS CONTAINING ZOLMITRIPTAN
`j
`/
`—_
`
`'
`
`'.
`
`‘
`
`.
`
`.
`
`\
`
`5
`
`6. 3 H A ‘JD 0/63 00/0"/s 13/ Julei ii/25/an
`i5‘:$o‘i am“ “PPM is
`9-!
`The present invention relates to new pharmaceutical formulations, their preparation
`and their use in treatment of disease. in particular the present invention relates to
`pharmaceutical formulations of the anti-migraine drug zolmitriptan for nasal application.
`Zolmitriptan has t