`
` Intational application No.
`
`PCT/SE02/01749
`
`Box I
`
`Observations where certain claims were found nnsearclrable (Continuation of item I of first sheet)
`
`This international search report has not been established in rcspect of‘certain claims under Article l7(2)(a) for the following reasons:
`
`
`
`
`
`L 8 Claims Nos.: 32-42
`because they relate to subject matter not required to be searched by this Authority, namely:
` see extra sheet
`
`
`
`
`
`‘ Claims Nos.: 1 -43
`
`because they relate to parts of the international application that do not comply with the prescribed requirements to such
`an extent that no meaningful international search can be carried out, specifically:
`
`see extra sheet
`
`
`
`
`because they are dependent claims and are not drafted in accordance with the second and third sentences of Rule 6.4(a).
`Observations where unity of invention is lacking (Continuation of item 2 of first sheet)
`This International Searching Authority found multiple invemions in this international application, as follows:
`
`
`
`3. D Claims Nos:
`
` As all required additional search fees were timely paid by the applicant, this international search report covers all
`searchable claims.
`
`
`
`
`
`
`
`As all searchable claims could be searched without effort justifying an additional fee,this Authority did not invite payment
`of any additional fee.
`
`3. D As only some ofthe required additional search fees were timely paid by the applicant, this international search report
`covers only those claims for which fees were paid, specifically claims Nos.:
`
`
`
`
`
`
` No required additional search fees were timely paid by the applicam. Consequently, this international search report is
`restricted to the invention first mentioned in the claims; it is covered by claims Nos.:
`'
`
`Remark on Protest
`
`D The additional search fees were accompanied by the applicant's protest.
`
`
`
` D No protest accompanied the payment ofadditional search fees
`
`Form PCT/ISA/210 (continuation of first sheet ( l)) (Julyl99li)
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2011 - 2001
`
`Patent Owner, UCB Pharma GmbH – Exhibit 2011 - 2001
`
`
`
`INTERNATIONAL SEARCH REPORT
`
`lntemational application No.
`PCT/SE01/01472
`
`Box 1.1
`
`Claims 32-42 relate to methods of
`
`treatment of
`
`the human or
`
`therapyl diagnostic methods
`animal body by surgery or by
`animal
`body/Rule
`39.1.(iv).
`practised on
`the
`human
`or
`Nevertheless, a search has been executed for these claims. The
`search
`has
`been
`based
`on
`the
`alleged. effects
`of
`the.
`
`compounds/copositions.
`
`Box 1.2
`
`relate to compounds defined by
`1-43
`claims
`The present
`reference to desirable properties, namely that they should be
`muscarinic receptor antagonists, 5alfa-reductase inhibitors,
`alfa-adrenergic
`receptor
`antagonists
`or
`5-HTlA receptor
`agonists or- antagonists. The claims cover ‘compositions,
`and
`uses of compositions,
`involving all
`compounds having these
`properties, whereas the application provides support within the
`meaning of Article 6 PCT and disclosure within the meaning of
`Article 5 PCT for only a very limited number of such compounds.
`
`the claims 1-43 also lack
`Independent of the above reasoning,
`clarity (Article 6 PCT). An attept is made
`to define the
`compounds by reference to results to be achieved. This lack of
`clarity in the present case is such as to render a meaningful
`search over
`the whole
`of
`the
`claimed scope
`impossible.
`Specifically,
`the
`terms
`"muscarinic
`receptor antagonists",
`"Salfa-reductase
`inhibitors",
`"alfa-adrenergic
`receptor
`antagonists"
`and "5—HT1A receptor agonists or antagonists"
`apparently relate
`to
`a very
`large
`amount of different
`compounds, which do not necessarily have to be defined with
`their
`respective
`receptor
`activities,
`thus
`rendering
`it
`impossible to perform a complete search.
`
`The search has been carried out for the compounds mentioned in
`the present claims 3-10 in combination with the compounds
`mentioned in the description.
`
`Form PCT/ISAIZIO (extra sham) (JulyI998)
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2011 - 2002
`
`Patent Owner, UCB Pharma GmbH – Exhibit 2011 - 2002
`
`
`
`Intemalional application No.
`
`PCT/SE 02/01748
`
`
`
`28/10/02
`
`INTERNATIONAL SEARCH REPORT
`Information on patent family members
`
`Paten
`
`me
`
`mber(s)
`
`date
`
`7703700 A
`
`24/04/01
`
`716050 3
`3635197 A
`103114 A
`9711108 A
`9900038 A
`127685 D
`3063164 B
`990472 A
`333842 A
`12299 A
`1226888 A
`9900331 A
`970426 A
`9902381 A
`3282617 B
`3282618 B
`2000169449 A
`2000178231 A
`331431 A
`9900204 T
`200001482 T
`5948792 A
`6040449 A
`9805641 A
`9706813 A
`
`17/02/00
`25/02/98
`30/11/99
`17/08/99
`16/08/99
`00/00/00
`12/07/00
`01/02/99
`25/05/01
`16/05/00
`25/08/99
`14/07/99
`31/08/98
`29/11/99
`20/05/02
`20/05/02
`20/06/00
`27/06/00
`19/07/99
`00/00/00
`00/00/00
`07/09/99
`21/03/00
`12/02/98
`11/02/98
`
`AU
`
`AU
`AU
`BG
`BR
`EE
`IL
`JP
`NO
`NZ
`SK
`CN
`CZ
`HR
`HU
`JP
`JP
`JP
`
`
`
`
`
`’
`
`
`
`
`
`cited in search report
`
`Patent document
`
`date
`
`NO
`
`0121167 A1
`
`29/03/01
`
`EP
`
`0930298 A1
`
`21/07/99
`
` 9921563
` 05/04/01
`731576 B
`1279099 A
`17/05/99
`2308070 A
`06/05/99
`1032400 A
`06/09/00
`2001521000 T
`06/11/01
`5942519 A
`24/08/99
`._——-.-----...—-—__-—-.._————-—-———--—---—--------__—_——.-—————————..—_—_—————-—
`
`
`
`
`
`1384701 A
`1222183 A
`MI992174 A
`6403594 B
`
`
`
`30/04/01
`17/07/02
`18/04/01
`11/06/02
`
`
`
`3263795 A
`14/03/96
`9417135 D
`00/00/00
` —._---__---..-——...———__——-u.-.——-———-—.......___—-————-.____—_———___——————___——————_—
`
`
`
`
`
`04/09/97
`9731637
`
` 2093297 A
`
`16/09/97
`EP
`0906100 A
`07/04/99
`IT
`240675 Y
`02/04/01
`IT
`1282705 B
`31/03/98
`IT
`MI960378 A,U
`28/08/97
`JP
`2001511763 T
`14/08/01
`5990114 A 23/11/99
`
`
`
`
`Form PCT/ISA/210 (patent family annex) (July 1998)
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2011 - 2003
`
`Patent Owner, UCB Pharma GmbH – Exhibit 2011 - 2003
`
`
`
`EAST Search History [zlvn-‘/?F5fif’\/(F)
`
`MC 2
`
`Hits
`
`Search Query
`
`DB5
`
`Default
`Operator
`
`Plurals
`
`1'ime Stamp
`
`/0 /7/6, 263
`
`15 US-3446901-$.DID. OR
`US-4988730-$.DID. OR
`US-5382600-$.DID. OR
`US-5559269-$.DID. OR
`US-5922914-$.DID. OR
`US-6517864-$.DID. OR
`US-6630162-$.DID. OR
`US-6713464-$.DID. OR
`US-6770295-$.DID. OR
`US-6783769-$.DID. OR
`US-6809214-$.DID. OR
`US-6809225-$.DID. OR
`US-6858650-$.DID. OR
`US-6890920-$.DID. OR
`Us-6911217-$.DID.
`
`1
`
`1
`
`1
`
`1
`
`1
`
`1
`
`("20030124179").PN.
`
`("20040186061").PN.
`
`("20050004223").PN.
`
`("20030152624").PN.
`
`("20030158176").PN.
`
`("20040064821").PN.
`
`USPAT
`
`OR
`
`OFF
`
`2006/07/1211:23
`
`US-PGPUB; OR
`USPAT
`
`US-PGPUB; OR
`USPAT
`
`US-PGPUB; OR
`USPAT
`
`US-PGPUB; OR
`USPAT
`
`US-PGPUB; OR
`USPAT
`
`US-PGPUB; OR
`USPAT
`
`OFF
`
`2006/07/1211:33
`
`OFF
`
`2006/07/1211:55
`
`OFF
`
`2006/07/1211:56
`
`OFF
`
`2006/07/1211:56
`
`OFF
`
`2006/07/1211:56
`
`OFF
`
`2006/07/1212:00
`
`2006/07/1212:01
`
`Ref
`#
`
`L1
`
`L2
`
`L3
`
`L4
`
`L5
`
`L6
`
`L7
`
`L8
`
`L9
`
`L10
`
`L11
`
`L12
`
`L13
`
`L14
`
`L17
`
`1
`
`("3216841").PN.
`
`US-PGPUB; OR
`USPAT
`
`OFF
`
`242
`
`ZENIIZ
`
`80
`
`L9 AND ZEN1TZ.IN.
`
`1
`
`1
`
`1
`
`1
`
`("6310248").PN.
`
`("6566537").PN.
`
`("6689916").PN.
`
`("6713464").PN.
`
`USPAT;
`USOCR
`
`USPAT;
`USOCR
`
`OR
`
`OR
`
`US-PGPUB; OR
`USPAT
`
`US-PGPUB; OR
`USPAT
`
`US-PGPUB; OR
`USPAT
`
`US-PGPUB; OR
`USPAT
`
`OFF
`
`2006/07/1212:01
`
`OFF
`
`2006/07/1212:02
`
`OFF
`
`2006/07/1212:02
`
`OFF
`
`2006/07/1212:02
`
`OFF
`
`2006/07/1212205
`
`OFF
`
`2006/07/1212:55
`
`324
`
`560/194 OR 564/316 OR 514/548
`OR 514/648
`
`US-PGPUB
`
`OR
`
`ON
`
`2006/07/1213:39
`
`7/12/06 1:43:30 PM
`C:\Documents and Settings\ZTucker\My Documents\EAST\Workspaces\DIPHENYLPROPYLAMINES CON.wsp
`
`Page 1
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2011 - 2004
`
`Patent Owner, UCB Pharma GmbH – Exhibit 2011 - 2004
`
`
`
`EAST Search History fiwmer:/%=NcF)
`
`Z0? 2
`
`10/76/62, 203
`
` L18
`
`US-PGPUB
`
`2006/07/12 13:39
`
`31
`
`L17 AND (MUSCARINIC OR
`DIISOPROPYL OR TOLTERODINE
`
`OR DEFROL)
`
`7/12/06 1:43:30 PM
`C:\Documents and Settings\ZTucker\My Document3\EAs'I'\Workspaces\DIPHENYLPROPYLAMINES CON.wsp
`
`Page 2
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2011 - 2005
`
`Patent Owner, UCB Pharma GmbH – Exhibit 2011 - 2005
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box I450
`Alexandria Virginia 22313-1450
`www.usplo.gov
`
`NOTICE OF ALLOWANCE AND FEE(S) DUE
`
`26646
`
`7590
`
`07/I 7/2006
`
`KENYON & KENYON LLP
`oNmoAvwAv
`NEW YORK, NY 10004
`
`E
`
`INER
`
`“Cm ZACHARY C
`
`.62,
`DATE MAILED: 07/I 7/2006
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`Claus Mecse
`0I/27/2004
`l0/766,263
`TITLE OF INVENTION: NOVEL DERIVATIVES OF 3,3-DIPHENYLPROPYLAMINES
`
`I296]/46l02
`
`3433
`
`APPLN. TYPE
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`ISSUE FEE DUE
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`PUBLICATION FEE DUE
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`PREV. PAID ISSUE FEE
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`TOTAL FEE(S) DUE
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`DATE DUE
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`nonprovisional
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`30
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`
`10/I 7/2006
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`THE APPLICATION IDENTIFIED ABOVE HAS BEEN EXAMINED AND IS ALLOWED FOR ISSUANCE AS A PATENT.
`PROSECUTION Q1 THE MERIIS 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 OR UPON
`PETITION BY THE APPLICANT. SEE 37 CFR 1.313 AND MPEP 1308.
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`THE ISSUE FEE AND PUBLICATION FEE (IF REQUIRED) MUST BE PAID WITHIN IHREE MONTHS FROM THE
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`11. PART B - FEE(S) TRANSMITTAL, or its equivalent, must be completed and returned to the United States Patent and Trademark Office
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`Patent Owner, UCB Pharma GmbH — Exhibit 2011 - 2006
`
`Patent Owner, UCB Pharma GmbH – Exhibit 2011 - 2006
`
`
`
`Complete and send this form, together with applicable fee(s), to: 1§’I_:1i1 Mail Stop ISSUE FEE
`Commissioner for Patents
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`PART B - FEE(S) TRANSMITTAL
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`WN-'.,m~
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`_
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`through 5 should be completed where
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`wm~*c°RREsP°~°E~w°~-=ss<~=~=vs=B'°°* ' mv°*w=°~m>
`26646
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`2:25..,:S.:“...*‘;;.‘*:.$=.:::.'°..";:'.":,':.%:,..*:.§.‘*‘..;
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`papers. Each additional paper, _such as an assignment or formal drawing, must
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`";:“.,::.:'" °"V°‘°P°
`facsimile
`273-2885, on the date indicated be ow.
`
`transmitted to the USPTO (£71)
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`Claus Meese
`01/27/2004
`l0/766,263
`TITLE OF INVENTION: NOVEL DERIVATIVES OF 3,3—DIPHENYLPROPYLAMINES
`
`1296]/46102
`
`3433
`
`
`
`APPLN. TYPE
`
`SMALL ENTITY
`
`ISSUE FEE DUE
`
`PUBLICATION FEE DUE
`
`PREV. PAID ISSUE FEE
`
`TOTAL FEE(S) DUE
`
`DATE DUE
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`nonprovisional
`
`NO
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`$1400
`
`$0
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`$1400
`
`$1400
`
`10/ 17/2006
`
`TUCKER, ZACI-IARY C
`
`I624
`
`514-548000
`
`
`
`1. Chan e of correspondence address or indication of "Fee Address" (37
`
`CFR 1. 63).
`ndence address (or Change of Correspondence
`CI Chan e of corres
`Address orm PTOI B/122) attached.
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`2. For printing on the patent front page, list
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`, no name will be printed.
`Number is required.
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`3. ASSIGNEE NAME AND RESIDENCE DATA TO BE PRINTED ON THE PATENT (print or type)
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`2
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`CI a. Applicant claims SMALL ENTITY status. See 37 CFR l.27. D b. Applicant is no longer claiming SMALL ENTITY status. See 37 CFR l.27(g)(2).
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`PTOL-85 (Rev. 07/06) Approved for use through 04/30/2007.
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`0
`
`"a°i3e"r’i° ’ow‘r’féFf‘tl‘é°EsTEii°’§.”F“n?a‘f'°€:
`
`l[Ils|5II'IEPflFlIII)I)I:§8r:I[II1E-IIEFCIO7
`
`Patent Owner, UCB Pharma GmbH – Exhibit 2011 - 2007
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria. Virginia 22313-1450
`www.uspto.gov
`
`10/766,263
`
`01/27/2004
`
`Claus Meese
`
`12961/46102
`
`3433
`
`07/17/2006
`26646
`KENYON & KENYON LLP
`oNmoAvwAv
`NEW YORK, NY 10004
`
`Wm
`TUCKER» ZACHARY C
`
`.624
`DATE MAILED: 07/17/2006
`
`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 80 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 80 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 1-(888)-786-0101
`or
`(571)-272-4200.
`
`P'l'OL-85 (Rev. 07/06) Approved for use through 04/30/2007.
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`Page 3 of 3
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`Patent Owner, UCB Pharma GmbH — Exhibit 2011 - 2008
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`Patent Owner, UCB Pharma GmbH – Exhibit 2011 - 2008
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`
`Application No.
`
`AppIicant(s)
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`Examiner
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`
`
`Notice of Allowability
`
`-- The MAILING DA TE 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.
`H _.
`
`Art UnitI
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`
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`1. E This communication is responsive to RCE 12 December 2005.
` 2. [Z The allowed c|aim(s) is/are 50-63.
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`3. [Z Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`a) X All
`b) E] Some‘
`c) C] None
`of the:
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`
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`
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`1. E] Certified copies of the priority documents have been received.
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`2. E Certified copies of the priority documents have been received in Application No. 09/700 094 .
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`3. I] Copies of the certified copies of the priority documents have been received in this national stage application from the
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`International Bureau (PCT Rule 17.2(a)).
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`* Certified copies not received: __
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`
`
` 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.
` 4. E] A SUBSTITUTE 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.
`
` 5. D CORRECTED DRAWINGS ( as “replacement sheets") must be submitted.
`(a) E] including changes required by the Notice of Draftsperson’s Patent Drawing Review ( PTO-948) attached
`
`
`
`1) I] hereto or 2) I] to Paper No./Mail Date
`
`(b) I] including 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 (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).
`
`
`
`6. 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.
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`Attachment(s)
`1. El Notice of References Cited (PTO-892)
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`2. El Notice of Draftperson's Patent Drawing Review .(PTO-948)
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`3. E Information Disclosure Statements (PTO-1449 or PTO/SB/08),
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`Paper No./Mail Date 12Dec05 21 Feb06
`4. El Examiner's Comment Regarding Requirement for Deposit
`of Biological Material
`
`5. E] Notice of Informal Patent Application (PTO-152)
`
`6. El Interview Summary (PTO-413),
`Paper No./Mail Date
`.
`7. E Examiner's Amendment/Comment
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`8. E Examiner's Statement of Reasons for Allowance
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`9. [3 Other
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`. U
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`.S. Patent and Trademark Office
`PTOL-37 (Rev. 7-05)
`
`Notice of Allowability
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`Part of Paper No./Mail Date 12072006
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`Patent Owner, UCB Pharma GmbH — Exhibit 2011 - 2009
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`Patent Owner, UCB Pharma GmbH – Exhibit 2011 - 2009
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`
`
`Application/Control Number: 10/766,263
`
`Page 2
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`Art Unit: 1624
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`EXAMiNER’S AMENDMENT
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`An examiner’s amendment to the record appears below. Should the changes
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`andlor 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
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`submitted no tater than the payment of the issue fee.
`
`The following amendments to the specification are necessary to render the
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`instant application compliant with 37 CFR 1.77 (arrangement and contents of the
`
`specification) and 37 CFR 1.78(a)(‘l )(iv)(i) (cross-reference to related applications), and
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`reflect the arrangement and contents of the specification of the parent application,
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`09/700,094. Applicants‘ preliminary amendment filed 27 January 2004 included a
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`cross-reference to the parent application, serial number 09/700,094, but that application
`
`had not yet issued as a patent. The cross—reference to the parent application is re-
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`stated hereinbelow, with added reference to the patent number of the parent
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`application.
`
`IN THE SPECIHCATION -
`
`At page 1. under the title of the application. insert the following paragraph:
`
`‘The present application is a Continuation Application of USSN 09/700,094. filed January 2, 2001,
`
`now US Patent 6,713,464, which in turn claimed the priority benefit of PCT/EP99/03212, filed May 11,
`
`1999.‘
`
`Followed by the heading:
`
`—BACKGROUND OF THE INVENTION--
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2011 - 2010
`
`Patent Owner, UCB Pharma GmbH – Exhibit 2011 - 2010
`
`
`
`Application/Control Number: 10/766,263
`Art Unit: 1624
`
`Page
`
`At page 3, line 17 (before the paragraph that begins “it is an object...") insert the
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`heading:
`
`I
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`-SUMMARY OF THE INVENTION--
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`At page 4, starting at line 4 (BEFORE the paragraph beginning that begins
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`“According to the present invention...” insert the foliowing paragraph and headings:
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`—BRIEF DESCRIPTION OF THE DRAWING
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`FIG. 1 shows the formation of the active metabolite from different prodrugs
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`by human liver S 9(%) in 1 hour.
`
`DETAILED DESCRIPTION OF THE INVENTION-—
`
`end of amendments
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`Patent Owner, UCB Pharma GmbH — Exhibit 2011 - 2011
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`Patent Owner, UCB Pharma GmbH – Exhibit 2011 - 2011
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`
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`Application/Control Number: 10/766,263
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`Page 4
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`Art Unit: 1624
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`Request for Continued Examination
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`A request for continued examination under 37 CFR 1.114, including the fee set
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`forth in 37 C.F.R. 1.17(e), was filed in this application after allowance. Since this
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`application is eligible for continued examination under 37 C.F.R.1.114, and the fee set
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`forth in 37 C.F.R. 1.17(e) has been timely paid, prosecution in this application has been
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`reopened pursuant to 37 C.F.R. 1.114.
`
`Applicants’ submissions of Information Disclosure Statements on 12 December
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`2005 and 21 February 2006 have been reviewed by the examiner.
`
`Allowable Subject Matter
`
`Claims 50-63 are allowed.
`
`The reasons for indication of allowable subject matter remain the same as were
`
`explained in the Notice of Allowability mailed 10 May 2005, and can be found in that
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`Office action.
`
`The submission of the Information Disclosure Statement of 23 August 2005, with
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`the Requested for Continued Examination under 37 C.F.R. 1.114 has been considered
`
`and none of the cited references are novelty-destroying or render obvious the claimed
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`compounds, methods and compositions.
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2011 - 2012
`
`Patent Owner, UCB Pharma GmbH – Exhibit 2011 - 2012
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`
`
`Application/Control Number: 10/766,263
`Art Unit: 1624
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`Page’5
`
`Comment
`
`On the PTO-1449 form accompanying the Information Disclosure Statement of
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`21 February 2006, the fourth U.S. patent application publication cited on the first page
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`of that form, although cited correctly, with the correct inventor listed, does not pertain in
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`any way to the present invention; it discloses some type of software used for publishing.
`
`The fifth item cited on that same page, U.S. patent 3,216,841, to Zenitz, is
`
`improperly cited. US 3,216,841 does not name Zenitz as an inventor. That particular
`
`item has therefore been lined through.
`
`V
`
`Conclusion
`All Post-Attowance Correspondence concerning this application must be mailed
`
`to:
`
`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 703-872-9306, 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.
`
`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.
`
`z7«Q2~—~
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`Patent Owner, UCB Pharma GmbH — Exhibit 2011 - 2013
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`Patent Owner, UCB Pharma GmbH – Exhibit 2011 - 2013
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`
`
`ATTY. DOCKET NO.
`12961/46102
`
`APPLICATION NO.
`l0/766,263
`
`APPLICANT
`Z.C. TUCKER
`
`FILING DATE
`January 27, 2004
`
`
`GROUP
`1624
`
`PPLEMENTAL INFORMATION
`DISCLOSURE
`STATEMENT BY APPLICANT
`
`Form PTO-1449
`
`
`
`
`
`PATENT/PUBLICATION
`NUMBER
`
`
`
`
`2003/0152624
`E 2003/0158176
`E— 2°04/064821
`
`6a31°»248
`6,566,537
`6,689,916
`
`—
`
`NUMBER
`
`/T.’
`
`.
`
`
`
`U. S. PATENT DOCUMENTS‘
`
`PATENT/PUBLICATION
`DATE
`
`
`
`NAME
`
`(1555
`
`5‘-‘BC’-A55
`
`FILINC
`DATE
`
`Aldrich etal. g=-
`August 14, 2003
`Richards etal. ==:
`August21, 2003
`Avril W004 T
`
`0°t°ber3°’2°°1 ET
`May 20, 2003
`Andersson et al. ==-
`Feb~arv1°»2°°4 £33
`
`
`
`
`
`FOREIGN PATENT DOCUMENTS
`
`.
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`NY0l IIOOI49 vl
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2011 - 2014
`
`Patent Owner, UCB Pharma GmbH – Exhibit 2011 - 2014
`
`
`
`OTHER DOCUMENTS
`
`AUTHOR, TITLE, DATE, PERTINENT PAGES, ETC.
`
`
`
`EX/\M.lNER
`mmm.
`
`
`
`
`
`
`Lipinski, et aI., “Experimental and computational approaches to estimate solubility and
`permeability in drug discovery and development settings" Elsevier Advanced Drug Delivery
`
`Reviews Vol. 23, pp. 3-25, 1997
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`
`
`
`Netzer, et al., “Screening lead compounds for QT interval prolongation” Drug Discovery Today
`‘
`Vol. 6, No. 2, pp.78-84, January 2001
`
`Nilvebrant & Sparf, “Differences between Binding Affinities of some Antimuscarinic Drugs in the
`parotid Gland and those in the Urinary Bladder and Ileum" Acta Pharmacol. et toxicol. Vol. 53,
`
`No. 4, pp. 304-313, October 1983
`
`2;’
`
`
`
`
`
`
`
`
`from Application Number 21-518, Center for Drug Evaluation
`
`
`Pharmacology/Toxicology Revie
`and Research, pp. 1-3.
`130%
`
`Roy, et al., “HERG, a Primary Human Ventricular Target of the Nonsedating Antihistamine
`Terfenadine" Circulation Vol. 94, No. 4, pp. 817-823, August 15, I996
`
`
`
`6
`DATE C0r1%D5%53£7r
`EXAMINER: Initial if citation considered, whether or not ciation is in confonnance with M.P.E.P. 609; draw line through citation if not in conformance and
`
`not considered. Include copy oftlis fonn with next communication to applicant.
`
`NYOI IIOOI49 vl
`
`Page 2
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`Patent Owner, UCB Pharma GmbH — Exhibit 2011 - 2015
`
`Patent Owner, UCB Pharma GmbH – Exhibit 2011 - 2015
`
`
`
`IoFY
`
`ATTY. DOCKET NO.
`12961/46102
`APPLICANT
`Z C TUCKER
`'
`'
`FILING DATE
`
`January 27, 2004
`
`APPLICATION NO.
`1 0/766,263
`
`GROUP
`
`1624
`
`
`
`fig
`
`..~ /'
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`'
`AL INFORMATION
`DISCLOSURE
`STATEMENT BY APPLICANT
`Form PTO-1449
`
`
`
`
`
`
`
`
`
`
`
`U. S. PATENT DOCUMENTS‘
`
`EXAMINER
`INITIAL
`
`PATENT/PUBLICATION
`NUMBER
`
`PATENT/PUBLICATION
`DATE
`
`NAME
`
`Cl-A55
`
`SUBCI-A55
`
`FILING
`DATE’
`
`
`
`A2
`
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`
`31
`
`AE
`
`TA
`
`3T
`
`A
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`A‘
`
`- copies of U.S. references are not enclosed
`
`FOREIGN PATENT DOCUMENTS
`
`
`
`
`
`INITIAL
`
`NUMBER
`
`
`
`
`
`EXAMINER
`
`
`
`
`
`
`‘$1’
`/
`
`March 21, 1955
`
`May 12, 1966
`
`was
`
`925 468 (in Gemmn, with
`English translation)
`1216318 (inGem1an, with
`yes
`English translation)
`2T
` -
` -
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`eumrnecz Q7»?/)1,-———- '2 “V” "W age DATE
`
`
`
`NYOI 1074294 vl
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2011 - 2016
`
`Patent Owner, UCB Pharma GmbH – Exhibit 2011 - 2016
`
`
`
`EXAMINER
`INITIAL
`
`DOCUMENT
`NUMBER
`
`DATE
`
`COUNTRY
`
`
`
`
`
`
`
`
`2oF'/
`
`fl
`’' —
`T3-
`T3-
`3:-
`
`T
`January 29, 1998
`wo 98/03067
`—%
`21’
`Q
`g /
`E wo 00/27364
`Mayl8. 2000
`— W001/34139
`May”-20°‘
`21/
`
`
`
`B%
`
`S
`
`
`
`OTHER DOCUMENTS
`
`AUTHOR, TITLE, DATE. PERTINENT PAGES, ETC.
`
`
`
`
`
`
`Abrams et al.,‘ ‘Tolterodine, a new antimuscarinic agent: as effective but better tolerated than
`oxybutynin in patients with an overactive bladder,“ 1998, Br. J. Urol. 812801-810
`Anderson et al., “Once daily controlled versus immediate release oxybutynin chloride for urge
`urinary incontinence," 1999, J. Urol. 161 :1 809-1812
`Andersson et al., “Pharmacological treatment of urinary incontinence," in Abrams
`
`P., Khoury S., Wein A. (Eds), Incontinence 2nd International Consultation on
`I____.
`ncontinence Plymouth, Plyrnbridge Distributors Ltd, UK, Plymouth, 2002, pp 479-511
`Andersson, “Antimuscarinics for treatment of overactive bladder,” 2004, Lancet Neurol. 3:46-53
`
`
`
`
`
`
`
`
`
`
`
`
`Andersson & Wein, “Pharmacology of the lower urinary tract: basis for current and future
`treatments of urinary incontinence," 2004, Pharrnacol. Rev. 56:581-631
`
`Appell et al., “Prospective randomized controlled trial of extended release oxybutynin chloride and
`tolterodine tartrate in the treatment of overactive bladder: results of the OBJECT study," 2001,
`'
`
`Mayo Clinic Proceedings 762358-363
`
`Breidenbach et al., “Pharmacodynamic profiling of the novel antimuscarinic drug fesoterodine on
`rat bladder," 2002, Proceedings of the International Continence Society, 32:449
`-
`Brynne et al., “Influence of CYP2D6 polymorphism on the pharmacolcinetics and
`
`pharmacodynarnics of tolterodine, 1998, Clin. Pharmacol. Thera. 63:S29-539
`
`Brynne et al., "Tolterodine does not affect the human in vivo metabolism of the probe drugs
`
`
`caffeine, debrisoquine, and omeprazole,” 1999, Br. J. Clin. Pharmacol. 47:145-150
`
`
`
`
`
`
`
`
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`
`
`
`
`
`Brynne et al., “Fluoxetine inhibits the metabolism of tolterodine — pharmacoldnetic implications
`and proposed clinical relevance," 1999, Br. J. Clin. Pharmacol. 48:553-563
`
`Brynne et al., “Ketoconazole inhibits the metabolism of tolterodine in subjects with deficient
`CYP2D6 activity," 1999, Br. J. Clin. Pharmacol. 48:564-572
`
`Cawello et al., “Multiple dose pharrnacokinetics of fesoterodine in human subjects,” 2002, Nauyn-
`
`Schrniedeberg‘s Arch. Pharmacol. 365 (Suppl. l):428, 2002
`Chancellor et al., “A comparison ofthe effects on saliva output ofoxybutynin chloride and
`tolterodine tartrate,” 2001, Clinical Therapeutics 23:753-760
`Chapple & Udo, “Delay to maximum effect in overactive bladder patients treated with oxybutynin
`or tolterodin