(check at least one box)
`
`a. IX]
`
`b. E]
`
`Except as may be indicated below in (b), all of the patents, publications or other
`information are in the English language or were cited in an English language
`Search Report, a copy of which is attached hereto (concise explanation not
`required).
`
`A concise explanation of the relevance of all patents, publications or other
`information listed that is not in the English language is as follows:
`
`c. IX]
`
`The following additional information is provided for the Examiner's
`consideration:
`
`The listed reference was cited by the Chinese Patent Office in an Office
`Action dated December 12, 2003, in a corresponding application.
`
`THIS IDS IS BEING FILED UNDER 37 C.F.R. § l.97(b)
`(check one box)
`
`a. El
`
`b. D
`
`c. El
`
`within three months of the filing date of a national application (37 C.F.R. §
`l.97(b) (1)). No fee or certification is required.
`
`within three months of the date of entry of the national stage as set forth in
`§1.491 in an international application (37 C.F.R. § l.97(b) (2)). No fee or
`certification is required.
`
`before the mailing date of a first Action on the merits (37 C.F.R. § l.97(b) (3)).
`No fee or certification is required. In the event that a first Office Action on the
`merits has been issued, please consider this IDS under 37‘C.F.R. § l.97(c) and
`see the certification under 37 C.F.R. § l.97(e) below, or, if no certification has
`been made, charge our deposit account a fee in the amount of $240.00 as
`required by 37 C.F.R. § 1.17(p).
`
`THIS IDS IS BEING FILED UNDER 37 C.F.R. § 1.9710):
`(check one box)
`
`before the mailing date of a Final Office Action under 37 C.F.R. § 1.113 (See 37 C.F.R. §
`l.97(c) (1)) or before the mailing date of a Notice of Allowance under 37 C.F.R. § 1.311 (See
`37 C.F.R. § l.97(c) (2)).
`
`a. D No certification; therefore, a fee in the amount of $180.00 is required by 37
`C.F.R. § 1.17(p).
`or
`
`Petitioner Amerigen Pharmaceuticals Ltd
`
`— Exhibit 1002 — Page 254
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 254
`
`

`
`b. I:] See the certification below. No fee is required.
`
`VI.
`
`THIS IDS IS BEING FILED UNDER 37 C.F.R. § 1.97(d):
`(check both boxes if applicable)
`
`before payment of the Issue Fee (See 37 C.F.R. § 1.97(d).
`
`a.lXI
`
`b.IX|
`
`See the certification below; and
`
`A fee in the amount of $180.00 is enclosed as required by 37 C.F.R. § 1.17(p).
`
`VII.
`
`CERTIFICATION UNDER 37 C.F.R. § 1.9716) (check only one box)
`
`The undersigned hereby certifies that
`
`a.IX]
`
`b.D
`
`each item of information contained in the IDS was cited in a communication
`
`from a foreign Patent Office in a counterpart foreign application not more than
`three months prior to the filing of this IDS; or
`
`no item of information contained in the IDS was cited in a communication from
`
`a foreign Patent Office in a counterpart foreign application or, to the best of my
`knowledge after making reasonable‘ inquiry, was known to any individual
`designated in 37 C.F.R. § l.56(c) more than three months prior to the filing of
`this statement.
`
`Some of the items of information were cited in a communication from a foreign
`Patent Office. As to this information, the undersigned certifies that each item of
`infonnation contained in the IDS was cited in a communication from a foreign
`Patent Office in a counterpart foreign application not more than three months
`prior to the filing of this IDS. As to the remaining information, the undersigned
`hereby certifies that no item of this remaining information contained in the IDS
`was cited in a communication from a foreign Patent Office in a counterpart
`foreign application or, to the best of my knowledge after making reasonable
`inquiry, was known to any individual designated in 37 C.F.R. § l.56(c) more
`than threemonths prior to the filing of this statement.
`
`Please charge Deposit Account No. 04-1105 in the amount of
`indicated fee. A triplicate copy of this paper is attached.
`
`for the above-
`
`No fee is required.
`
`Petitioner Amerigen Pharmaceuticals Ltd
`
`— Exhibit 1002 — Page 255
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 255
`
`

`
`If the Examiner has any questions concerning this IDS, he/she is requested to contact the
`undersigned. If it is determined that this IDS has been filed under the wrong rule, the PTO is requested
`to consider this IDS under the proper rule (with a petition, if necessary) and charge the appropriate fee
`to Deposit Account No. 04-1105.
`
`Respectfully submitted,
`
`ifi Cr&l-/
`
`Christine C. O’Day (Reg. No. 38,256)
`EDWARDS & ANGELL, LLP
`P.O. Box 55874
`
`Boston, MA 02205
`
`Tel: (617)439-4444
`
`Date:
`
`3’/7"d“(
`
`Customer No. 21874
`
`BOS2_433420.1
`
`Petitioner Amerigen Pharmaceuticals Ltd
`
`— Exhibit 1002 — Page 256
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 256
`
`

`
`
`
`Sheet
`1 of 1
`
`ATTY DOCKET NO.
` SERIAL NO.
`
`
`
`58827(45107)
`10/130,214
`
`
`INFORMATION DISCLOSURE STATEMENT
`
`
`
`
`
`
`
`APPLICANT(S): Claus Meese
`
`FILING DATE:
`
`ART UNIT:
`
`May 14, 2002
`
`1624
`
`UNITED STATES PATENT DOCUMENTS
`
`
`
`EXAM.‘
`INITIAL
`
`DOCUMENT
`NUMBER
`
`AA
`
`5,686,464
`
`DATE
`
`NAME
`
`
`
`CLASS
`
`11/11/97
`
`R.A. Johansson
`et a1.
`
`514
`
`sun
`cI.Ass
`
`FILE DATE
`
`315
`
`
`
`
`
`
`FOREIGN PATENT nocUMENTs
`
`
`
`DOCUMENT NUMBER
`
`PUBLISHED
`DATE
`
`COUNTRY
`
`CLASS
`
`SUB
`CLASS
`
`TRAN YES/NO
`
`OTHER DOCUMENTS (INCLUDING AUTHOR, TITLE, DATE, PERTINENT PAGES, ETC.)
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1002 — Page 257
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 257
`
`

`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`WWW.USplU.g0V
`
`NOTICE OF ALLOWANCE AND FEE(S) DUE
`
`7590
`
`01/28/2004
`
`Peter F. Corless
`P O Box 9169
`Boston MA 02209
`
`EXAMINER
`
`TUCKER, ZACHARY c
`
`1624
`
`DATE MAILED: 0l/28/2004
`
`APPLICATION NO.
`
`FILING DATE
`
`'
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`CIaus«Meese
`05/I4/2002
`10/130,214
`TITLE OF INVENTION: STABLE SALTS OF NOVEL DERIVATIVES OF 3,3-DIPHENYLPROPYLAMINES
`
`‘4l946/3221354
`
`9833
`
`nonprovisional
`
`NO
`
`$1330
`
`$0’
`
`$1330
`
`04/28/2004
`
`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.
`'
`
`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’ ABANDONEDL
`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-85B (OR.
`AN EQUIVALENT) MUST BE RETURNED WITHIN THIS PERIOD”EVEN IF NO FEE IS DUE OR THE APPLICATION WILL’
`BE‘ REGARDED AS ABANDONED.
`'
`.
`F
`
`HOW TO REPLY TO THIS NOTICE:
`
`1. Review the SMALL ENTITY status shown above.
`
`If the SMALL ENTITY is shown as YES, verify your current
`SMALL ENTITY status:
`A. If the status is the same, pay the TOTAL FEE(S) DUE shown
`above.
`
`If~the SMALL ENTITY is shown as NO:
`
`A. Pay TOTAL FEE(S) DUE shown above, or
`
`‘If the status is changed-, pay the PUBLICATION -FEE (if
`B.
`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.
`
`11. 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 fonn 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. 11/03) Approved for use through 04/30/2004.
`
`Page 1 of3
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1002 — Page 258
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 258
`
`

`
`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
`(703) 746-4000
`or FAX
`through’ 4 should be completed where
`INSTRUCTIONS: This form should be used for transmitting the ISSUE FEE and PUBLICATION FEE (if required). Blocks I
`ap ropriate. All further correspondence including the Patent, advance orders and notification of maintenance fees will be mailed 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 or use Block I)
`
`7590
`
`01/28/2004
`
`Peter F. COTICSS
`p O Box 9169
`Boston, MA 02209
`
`Note. A Cenificme of main“ can only be used for domestic mailings of ‘he
`Fee(s) Transmittal. This certi icate cannot be used for any other accompanying
`papers. Each additional paper, such as an assignment or formal drawing, must
`ave its own certificate of mailing or transmission.
`
`Certificate of Mailing or Transmission
`that this Fee(s Transmittal is being deposited with the United
`I hereb certi
`ervice with su icient post ge for first class mail in an e
`elo e
`States ostal
`addressed to the Mail Stop ISSUE FEE address above, or being fzibvsimile
`transmitted to the USPTO, on the date indicated below.
`i
`I
`
`(Depositors name)
`(Signature)
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTORV
`
`— ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`Claus Meese
`-
`075/I4/2002
`I0/l30,2l4
`TITLE OF INVENTION: STABLE SALTS OF NOVEL DERIVATIVES OF 3,3—DlPHENYLPROPYLAMINES
`
`I
`
`41946/32854
`
`9833
`
`APPLN. TYPE
`
`‘
`
`SMALL ENTITY
`
`ISSUE FEE
`
`.
`
`nonprovisional
`
`EXAMINER.
`
`NO
`'
`
`TUCKER’,»ZACHARY:C
`
`'
`
`$1330
`ART. UNIT.
`
`' r1624
`
`.
`
`V
`
`PUBLICATION FEE
`
`TOTAL FEE(S) DUE
`
`$0
`CLASS-SUBCLASS
`
`514-530000
`
`$1330
`
`"
`
`DATE DUE
`
`04‘/23/2004
`
`I. Change of correspondence address orindication of "Fee Address"-(37
`CFR I~363)-
`'
`Cl Change of corres iondence address (or Change of Correspondence
`, Address form PTO SB/l22),attached.
`I
`n ica ion onn
`ee-
`in ica ion or
`ee
`ress
`ress
`"1 d_
`D“: Add
`W d_
`t_
`(
`"F Add
`t,
`,f
`PTO/SB/47; Rev'03~02 or more recent) attached: Use of a Customer
`Numberis required.
`
`2, For printing on the patent front page, list (I) the
`names ofi up to 3 registered patent attorneys or
`agents OR, alternatively, (2) the name of a single
`firm (havingas a member a registered attorney or
`-
`-
`~
`V
`agent) and the names of up to 2 registered patem»
`a[ifirEe_yS.0r’ :gemS' If no name '5 hstedf "ow mime“
`W‘
`- 59"“-‘C -
`
`'
`
`3. ASSIGNEE NAMESAND RESIDENCE DATA TO BE PRINTED ON‘THE PATENT_(print or type)-
`appropriate when an assignment has
`PLEASE NOTE: Unless an assignee is identified below, no assignee data will appear on the patent. Inclusion‘ of assignee data is onl
`been previously submitted to the USPTO or is being submitted under separate cover, Completion of this formvis NOT a substitute for fi ing an assignment.
`(A) NAME or ASSIGNEE
`-(B) RESIDENCE: (CITY and STATE OR COUNTRY)
`
`Please check the appropriate assignee category or categories (will not be printed on.the patent);
`I
`4a. The following fee(s) are enclosed:
`R
`4b_. Payment of Fee(s):
`3 Issue Fee
`JA check in the amount of the fee(s) is enclosed.‘
`. Cl Publication Fee
`3 Payment by credit card. Fonn PTO-2038' is attached.
`ayment, to
`Cl Advance Order - # of Copies
`CI The Director is hereby authorized by charge the required fee(s), or credit any ove
`V
`Deposit Account Number
`‘
`‘ (enclose an extra copy of this form .
`
`C! corporation or other private group entity D government
`
`CI individual
`
`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 thevapplication identified above.
`
`(Authorized Signature) ,
`I
`
`NOTE; The Issue Fee and Publication Fee (if required) will not be accepted from anyone 7
`other than theraplplicant; a- registered attomegl or agent; or the assignee or other party in
`interest as shown y the records of the United tales
`ateiit and Trademark Office.
`This collection of infomiation is re uired by 37 CFR I.3I I. 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. I22 and 3 CFR 1.14. 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 ete this fonn and/or
`suggestions for reducing this burden, should be sent to the Chief In orrnation Officer, U.S.
`Patent and Trademark Office, US. Department of Commerce, Alexandria, Vir inia
`223l3—I450.- DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDR SS.
`SEND TO: Commissioner for Patents, Alexandria, Virginia 22313-1450.
`Under the Paperwork Reduction Act of I993, no
`ersons are required to respond to a
`collection of infomiation unless it displays a valid OM control number.
`
`PTOL—85 (Rev. I I/03) Approved for use through 04/30/2004.
`
`OMB 0651-0033
`
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`
`TRANSMIT THIS FORM WITH FEE(S)
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1002 — Page 259
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 259
`
`

`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`I’.O. Box 1450
`_
`_
`Alexandria, Virginia 223 13-1450
`www.u5pI0.guv
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`10/] 30,214
`
`05/I4/2002
`
`Claus Meese
`
`41946/32854
`
`9833
`
`7590
`
`01/28/2004
`
`Peter F. Corless
`P O Box 9I69
`Boston MA 02209
`
`EXAMINER
`
`TUCKER, ZACHARY c
`
`~
`
`1624
`
`DATE MAILED: 01/28/2004
`
`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 20 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 20 day(s).
`
`If a Continued Prosecutions Application (CPA) was filed in the above‘-identified application, the filing date that
`determines Patent Term Adjustment is the filing dateof 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).
`
`Ahyquestions 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. 11/03) Approved for use through 04/30/2004.
`
`Page 3 of 3
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1002 — Page 260
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 260
`
`

`
`Notice ofAllowability
`
`Application No.
`App|icant(s)
`MEESE, CLAUS
`
`
`1E3Q,‘:’,?;.i1,4
`Art Unit
`
`Zachary C. Tucker
`
`1624
`
`-- 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 initiativ
`of the Office or upon petition by the applicant. See 37 CFR 1.313 and MPEP 1308.
`-
`
`1. IX This communication is responsive to 10 November 2003.
`
`2. E The allowed c|aim(s) is/are 1-6 8-17 26 and 28-34.
`3. IX] The drawings filed ori"fl‘_"_‘5§l’e accepted by the Examiner.
`4. IX] Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`a) X All
`b) |:l Some*
`c) I:] None
`of the:
`
`1. [:1 Certified copies of the priority documents have been received.
`
`2. [:1 Certified copies of the priority documents have been received in Application No.
`
`3. IE 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:
`
`5. [:I Acknowledgment is made of a claim for domestic priority under 35 U.S.C. § 119(e) (to a provisional application) since a specific
`reference was included in the first sentence of the specification or in an Application Data Sheet. 37 CFR 1.78.
`(a) I:] The translation of the foreign language provisional application has been received.
`6. I:] Acknowledgment is made of a claim for domestic priority under 35 U.S.C. §§ 120 and/or 121 since a specific reference was included
`in the first sentence of the specification or in an Application Data Sheet. 37 CFR 1.78.
`
`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
`
`7. D APSUBSTITUTE OATH OR DECLARATION must be submitted. Note the attached EXAMlNER‘S AMENDMENT or NOTICE OF
`INFORMAL PATENT APPLICATION (PTO—152) which gives reason(s) why the oath or declaration is deficient.
`
`8. E] CORRECTED DRAWINGS (as “replacement sheets”) must be submitted.
`(a) I] including changes required by the Notice of Drafts'person’s Patent Drawing Review ( PTO-948) attached
`1) [:1 hereto or 2) I] to Paper No.
`
`, which has been approved by the Examiner.
`(b) I:] including changes required by the proposed drawing correction filed
`(c) I:] including changes required by the attached Examiner's Amendment I Comment or in the Office action of Paper No.
`
`
`
`Identifying in‘dicia 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 margin according to 37 CFR 1.121(d).
`
`9; [:1 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)
`
`1l:] Notice of References Cited (PTO-892)
`2E] Notice of Draftperson's Patent Drawing Review (PTO-948)
`3X] Information Disclosure Statements (PTO—1449 or PTO/SB/08),
`Paper No_ “Ma 02
`4D Examiner's Comment Regarding Requirement for Deposit
`of Biological Material
`
`7‘
`
`5I:| Notice of Informal Patent Application (PTO-152)
`6|] Interview Summary (PTO—413), Paper No.
`.
`.
`7IZ] Examiners Amendment/Comment
`BIXI Examiner's Statement of Reasons for Allowance
`9|] other
`
`.
`
`U.S. Patent and Trademark Office
`PTOL-37 (Rev. 11-03)
`
`Notice of Allowability
`
`,
`Part of Paper No. 1601200
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1002 — Page 261
`
`
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 261
`
`

`
`Application/Control Number: 10/130,214
`Art Unit: 1624
`
`Page 2
`
`EXAMlNER’S AMENDMENT’
`
`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 voicemail
`
`message from Christine C. O’Day 18 January 2004, which was in response to a
`
`message left by the examiner for Ms. O’Day on 16 January 2004.
`
`IN THE SPECIFICATION —
`
`Insert the heading “Brief Description of the Drawing" before the second to last
`
`paragraph on page 14 of the specification.
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1002 — Page 262
`
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 262
`
`

`
`Application/Control Number: 10/130,214
`Art Unit: 1624
`
`4
`
`Page 3
`
`Response to Amendment
`
`As requested in the correspondence from applicants dated 5 November 2003,
`
`which is in reply to the Office action of4 August 2003, claims 3, 5, 6, 8 and 12-15 have
`
`been amended, claims 7, 18-25 and 27 have been cancelled and new claims 31-34
`
`added.
`
`Status of Claim Rejections - 35 usc § 112
`
`In the previous Office action, dated 4 August 2003, claims 7, 18-25 and 27-30
`
`were rejected under 35 U.S.C. 112, second paragraph, for indefiniteness.
`
`Claims 7, 18-25 and 27 have been cancelled, mooting the rejection of that claim
`
`under this statute.
`
`Claims 28-30 have been amended soas to define proper methods of
`
`manufacture under this statute, and therefore the rejection of claims 28-30 under 35
`
`U.S.C. 112, second paragraph, is hereby withdrawn.
`
`Status of Claim Rejections - 35 USC § 101
`
`In the previous Office action, dated 4 August 2003 claims 21, 22 and 27-30 were
`
`rejected under 35 U.S.C. 101 for specifying non-statutory subject matter.
`
`Claims 21, 22 and 27 have been cancelled, mooting the rejection of those claims
`
`under this statute.
`
`Claims 28-30 have been amended so as to define proper methods of
`
`manufacture under this statute, and therefore the rejection of claims 28-30 under 35
`
`U.S.C. 101 is hereby withdrawn.
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1002 — Page 263
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 263
`
`

`
`Application/Control Number: 10/130,214
`Art Unit: 1624
`
`Page 4
`
`Status of Obviousness-type Double Patenting
`
`in the previous Office action, dated 4 August 2003, claims 1-7 were provisionally
`
`rejected under the judicially created doctrine of obviousness—type double patenting as
`
`being unpatentable over allowed claims 3 and 4 of U.S. application no. 09/700,094.
`
`The rejection is withdrawn in view of the Terminal Disclaimer over the commonly-
`
`owned cited application.
`1
`
`Status of Claim Rejections - 35 USC § 102
`
`In the previous Office action, dated 4 August 2003, claims 18 and 23 were
`
`rejected as being anticipated by WO 94/11337 (Johansson et al).
`
`Both claims 18 and 23 have been cancelled, mooting the rejection.
`
`Status of Claim Rejections - 35 USC § 103
`
`In the previous Office action, dated 4 August 2003, claims 20 and 25 were _.
`
`rejected under 35 U.S.C. 103(a) as being unpatentable over Johansson et al.
`
`Both claims 20 and 25 have been cancelled, mooting the rejection.
`
`In the previous Office action, dated 4 August 2003, claims 19 and 24 were
`
`rejected as being unpatentable over WO 98/43242 (Johansson et al ‘942).
`
`Both claims 19 and 24 have been cancelled, mooting the rejection.
`
`Allowable Subject Matter
`
`Claims 1-6, 8-17, 26 and 28-34 are allowed.
`
`The following is an examiner's statement of reasons for allowance:
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1002 — Page 264
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 264
`
`

`
`Application/Control Number: 10/130,214
`Art Unit: 1624
`
`Page 5
`
`All of the previously stated rejections have been obviated by cancellation of the
`
`rejected claim, or by amendment.
`
`An updated search afforded no additional applicable prior art.
`
`New claims 31-34 are patentable under 35 U.S.C. 112, first paragraph, as they
`
`comply with the written description and enablement requirement.
`
`if not for the Terminal Disclaimer over 09/700,094, claims 31-34 would be the
`
`subject of an obviousness-type double patenting rejection over that application.
`
`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.”
`
`Information Disclosure Statement
`
`A PTO-1449 form, with a received dated of 14 May 2002, is enclosed herewith,
`
`initialed and signed.
`
`All Post—Allowance Correspondence concerning this application must be mailed
`
`to:
`
`Conclusion
`
`Mail Stop Issue Fee
`Commissioner for Patents
`P.O. Box 1450
`
`Alexandria, VA 22313-1450
`
`Or you can fax them to the Office of Patent Publications at 703-308-5083, in order to
`expedite the handling of such correspondence as amendments under 37 CFR 1.312;
`information disclosure statements, and formal drawings. Sending Post—Allowance
`papers to Technology Center 1600 will only cause delays in matching papers with the
`case.
`
`For information concerning status of correspondence sent after receipt of the
`Notice of Allowance, please contact the Correspondence Branch at (703) 305-8027.
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1002 — Page 265
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 265
`
`

`
`Application/Control Number: 10/130,214
`Art Unit: 1624
`
`Page 6
`
`The Notice of Allowance also has an insert containing contact information on other
`items, including Issue Fees, receipt of formal drawings and the status of the application.
`zt
`2cQ.ZL¢_..
`
`
`
`’ chord L. soiymond
`, Primary Examiner
`Ari Unit 1624
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1002 — Page 266
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 266
`
`

`
`_
`
`\
`
`’""t0/130213
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`the amount oi time you are required to complete this lorrn should be sent to the Chief lntormati
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`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1002 — Page 267
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 267
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`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1002 — Page 268
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 268
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 269
`
`

`
`Search Notes
`
`Application No.
`
`App|icant(s)
`
`10/130,214
`Examiner
`
`MEESE, CLAUS
`Art Unit
`
`Zacha C. Tucker
`
`1624
`
`Class
`
`SEARCHED
`Date
`
`Examiner
`
`SEARCH NOTES
`(INCLUDING SEARCH STRATEGY)
`DATE
`
`3$39-4:Q,4 Hg’$> $,.*2
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`INTERFERENCE SEARCHED
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`U.S. Patent and Trademark Office
`
`Part of Paper No. 16012004
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1002 — Page 270
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 270
`
`

`
`Qisgigai
`ec’d Pcr/pm 14 MAY 2002
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`SPECIFICATION
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`
`3,3-diphenylpropylamines
`
`The present
`
`invention concerns highly pure, crystalline,
`
`stable compounds of novel derivatives of 3,3-
`
`diphenylpropylamines in the form of their salts, a method for
`
`manufacturing these and highly pure, stable,
`
`intermediate
`
`products.
`
`From document PCT/EP99/03212 novel derivatives of 3,3-
`
`diphenylproprylamines are known.
`
`These are valuable prodrugs for the treatment of urinary
`
`incontinence and other spasmodic complaints, which overcome
`
`the disadvantage of the active substances available to date,
`
`namely inadequate absorption of the active substance by
`
`biological membranes or the unfavourable metabolism of these.
`
`Furthermore these novel prodrugs have improved
`
`pharmacokinetic characteristics compared with Oxybutynin and
`
`Tolterodint
`
`Preferred compounds from the group of these novel derivatives
`
`of 3,3-diphenylpropylamines are esters of aliphatic or
`
`aromatic carboxylic acids with the general formula A referred
`
`_to below
`
`Formula A
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1002 — Page 271
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 271
`
`

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`
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`
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`Petitioner My|an'JPharmaceutica|s Inc. — Exhibit 1002 — Page 272
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1002 - Page 272
`
`

`
`PATENT APPLICATION FEE DETERMINATION RECORD
`Effective October 1, 2001
`
`Application or Docket Number
`
`10l13021b
`
`CLAIMS AS FILED - PART I
`
`SMALL ENTITY
`
`OTHER THAN
`OR SMALL ENTITY
`
`TE
`
`INDEPENDENT CLAIMS
`
`'
`
`MULTIPLE DEPENDENT CLAIM PRESENT
`
`* If the difference in
`
`column 1 is less than zero. enter "0" in column 2
`
`CLAIMS AS AM ENDED - PART II
`Column 2
`HIGHES
`NUMBER
`PREVIOUSLY
`PAID FOR
`
`“E,7%"2,'."°
`
`C ' M
`
`REMAINING
`AFTER
`AMENDMENT
`_@
`'"°°°°"'*°'?* -W
`FIRST PRESENTATION OF MULTIPLE DEPENDENT CLAIM
`
`H HEST
`NUMBER
`PREVIOUSLY
`PAID FOR
`
`REMAINING
`AFTER
`AMENDMENT
`
`.
`
`PREVIOUSLY
`PAID FOR
`
`In