UNITED STATES PATENT AND TRADEMARK Omca
`
`UNITED S'I‘A'I‘$ DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Ad.dreu:COMMISSIONER FOR PATENTS
`i>.o. Box 1450
`Akxandrh, vuginsa 22313-use
`""“’-“'P‘°-B°V
`
`NOTICE OF ALLOWANCE AND FEE(S) DUE
`
`7590
`
`06/ l 8/20.03
`
`John P White
`Cooper & Dunham LLP
`1185 Avenue of the Americas
`New York, NY 10036
`
`,
`
`—_
`
`MCKENZIE, THOMAS C
`
`‘
`
`1624
`
`514-266400
`
`DATE MAILED: 06/18/2003
`
`APPLICATION NO.
`
`09/71 1,272
`
`FILING DATE
`
`1 1/09/2000
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`Timothy Norris
`
`62814-A/JPW/GIG
`
`6700
`
`POLYMORPH ON N-(3-ETHYNYLPHENYL)-6,
`STABLE
`INVENTION:
`TITLE OF
`HYDROCHLORIDE, METHODS OF PRODUCTION, AND PHAMACEUTICAL USES THEREOF
`
`7—BIS
`
`(2METHOXYETHOXY)4—QUINAZOLINAMINE
`
`APPLN. TYPE
`
`nonprovisional
`
`SMALL ENTITY
`NO
`
`ISSUE FEE
`
`$1300
`
`PUBLICATION FEE
`$0
`
`TOTAL FEE(S) DUE
`
`$1300
`
`DATE DUE
`
`09/ I 8/2003
`
`THE APPLICATION IDENTIFIED ABOVE HAS BEEN EXAMINED AND IS ALLOWED FOR ISSUANCE AS A PATENT.
`EB QN [HE MERIIS IS QLQSEQ, 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 IHBEE MQNIHS FROM THE
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`your ISSUE FEE and PUBLICATION FEE (if required). Even if the fee(s) have already been paid, Part B - Fee(s) Transmittal should be
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`PTOL-85 (REV. 05-03) Approved for use through 04/30/2004.
`
`Page 1 of 4
`
`APOTEX EX. 1006-001
`
`

`
`.
`
`PART B - FEE(S) TRANSMITTAL
`
`Complete and send this form, together with applicable fee(s), to: Mail Mail Stop ISSUE FEE
`Commissioner for Patents
`Alexandria, Virginia 22313-1450
`(703)746-4000
`Ear
`
`INSTRUCTIONS: This form should
`_used.for transmitting the ISSUE FEE an _PUB_LICA'I‘ION FEE (if l’Cql.lIl_'Cd{>.e3 oc s I
`through 4 s ould be completed where
`ap ropriate. All further correspondence including the Patent, advance orders arid_notif'ication of maintenance fees will
`mailed to the current corre ondence address as
`in icated unlgss corrfected below or directed otherwise in Block I, by (a) specifying a new correspondence address; and/or (b) indicating a separate " EE ADDRESS" for
`maintenance ee noti ications.
`0 =
`81 y
`-up WI
`finywmtc °fl5°WS°
`0°
`ote:
`certi icate 0 mar mg can on y
`use
`or omestic mai ings o t e
`05/13/2003
`Fee(s) Transmittal. This certificate cannot be used for ‘any other
`accom ariying papers. Each additional paper, such as an assignment or
`forrna drawing, must have its own certificate of mailing or transmission.
`Certificate of Mailing or Transmission
`certify that this Fee(s) Transmittal
`is being deposited with the
`I hereb
`United tates Postal Service with sufficient ostage for first class mail in an
`envelope addressed to the Box Issue Fee a dress above, or being facsimile
`transmitted to the USPTO, on the date indicated below.
`
`7590
`
`John P White
`Cooper & Dunham LLP
`1185 Avenue ofthe Americas
`k
`0036
`NCW YOT , NY 1
`
`-
`
`
`
`
`
`
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`
`
`
`FIRST NAMED INVENTOR
`
`APPLICATION NO.
`
`FILING DATE
`
`Timothy Norris
`I 1/09/2000
`09/7] 1,272
`STABLE POLYMORPH ON N~(3-ETHYNYLPHENYL)-6,
`TITLE OF
`INVENTION:
`HYDROCHLORIDE, METHODS OF PRODUCTION, AND PHAMACEUTICAL USES THEREOF
`
`6700
`62814-A/IPW/GIG
`(ZMETHOXYETHOXY)-4-QUINAZOLINAMINE
`
`7-BIS
`
`APPLN. TYPE
`
`SMALL ENTITY
`
`,
`
`nonprovisional
`
`NO
`
`ISSUE FEE
`
`S I 300
`
`PUBLICATION FEE
`
`TOTAL FEE(S) DUE
`
`so
`
`$ 1 300
`
`DATE DUE
`
`09/ I 8/2003
`
`EXAMINER
`
`ART UNIT
`
`CLASS-SUBCLASS
`
`MCKENZIE, THOMAS C
`
`I624
`
`-
`514-266400
`1. Chan e of correspondence address or indication of "Fee Address" (37
`
`
`2. For printing on the patent front page, list (I)
`CFR L 63).
`the names of up to 3 registered patent attorneys
`1
`or agents OR, alternatively, (2) the name of a
`Single mm (having as a member 8 registered
`2
`attorney or agent) and the names of up to 2
`-
`3
`iegismmd patent anpmeys 5” agents‘ If “G name
`is listed, no name will be printed.
`
`
`
`
`Cl Change of corre ondence address (or Change of Correspondence
`Address form PTO 8/ I22) attached.
`,
`.
`,
`,
`.
`Cl "Fee Address" indication (or "Fee Address" Indication form
`PTO/SB/47; Rev 03-02 or more recent) attached. Use of a Customer
`Number is I.equired_
`
`
`3. ASSIGNEE NAME AND RESIDENCE DATA TO BE PRINTED ON THE PATENT (print or type)
`
`i
`ee is identified below, no assignee data will appear on the. patent. Inclusion of assignee data is only appropriate when an assignment has
`PLEASE NOTE: Unless an assi
`been previously submitted to the ’SPTO or is being submitted under separate cover. Completion of this form is NOT a substitute for fi
`rig 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)
`4a. The following fee(s) are enclosed:
`41). Payment of Fee(s):
`
`Cl individual
`
`C] corporation or other private group entity Cl government
`
`C} A check in the amount of the fee(s) is enclosed.
`3 “Sue Fee
`Cl Payment by credit card. Form PTO-2038 is attached.
`0 Publication Fee
`-
`_
`U The Commissioner is hereby authorized by char e the required fce(s , or credit an overpayment, to
`
`# Ofcopms '-‘T:D Advance Order Deposit Account Number _____T(encFose an extra copy 0 this form). y
`
`Commissioner 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)
`
`(Date)
`
`NOTE; The Issue Fee and Publication Fee (if required) will not E accepted Earn anyone
`other than the applicant; a registered attome or agent; or the assignee or other party in
`interest as shown y the records ofthe United States atent and Trademark Office.
`II’IlS’ collection of infomiation is re uired by 37 CFR L3] 1. Ihe 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 l.I4. This collection is
`estimated to take I2 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 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.
`
`
`
`
`
`
`
`
`Under_the Paperwork 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. 05-03) Approved for use through 04/30/2004. OMB 0651-0033
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`
`APOTEX EX. 1006-002
`
`

`
`
`
`UNITED STATES PATENT AND TRADEMARK Omca
`
`UNITED STATIE DEPARTMENT OF’ COMMERCE
`United States Patent and Trademark Omce
`A.d<kecr.COlvfMISSIONER FOR PATENTS
`P.0. Box 1450
`Alexandria, Vnykiia 22313-I450
`vrIrw.uIpto.gov
`
`09/71 1,272
`
`1 l/09/2000
`
`Timothy Norris
`
`62814-A/JPW/GJG
`
`6700
`
`7590
`
`06118/2003
`
`John p white
`Cooper & Dunharn LLP
`nssomammericas
`New York, NY 10036
`
`’
`A
`
`A
`
`'
`
`MCKENZIE, THOMAS c
`
`1524
`DATE MAILED: 06/18/2003
`
`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 days. 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 term adjustment will be 0 days.
`“
`
`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)
`’
`
`Any questions regarding the patent term extension or adjustment determination should be directed to the Office of
`Patent Legal Administration at (703)305-1383.
`
`PTOL-85 (REV. 05-03) Approved for use through 04/30/2004.
`
`Page 3 of 4
`
`APOTEX EX. 1006-003
`
`

`
`
`
`UNITED STATES PATENT AND TRADEMARK Omen:
`
`09/71 1,272
`
`1 1/09/2000
`
`Timothy Norris
`
`7590
`
`O6/I8/2003
`
`John P White
`Cooper & Dunham LLP
`1185 Avenue of the Americas
`New York, NY 10036
`UNITED STATES
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Addreer COMMISSIONER I-‘OR PATENTS
`PO. Box 1450
`Alzmndxis, Virginia 223]!-1450
`wwvI.urpto.g:7v
`
`_
`
`«
`
`62814-A/JPW/GJG
`
`6700
`
`MCKENZIE, THOMAS c
`
`1624
`DATE MAILED: 06/ l 8/2003
`
`Notice of Fee Increase on January 1, 2003
`
`If a reply to a "Notice of Allowance and Fee(s) Due" is filed in the Office on or after January 1, 2003, then the
`amount due will be higher than that set forth in the "Notice of Allowance and Fee(s) Due" since there will be an increase
`in fees effective on January 1, 2003. S_e_e Reyisjgn Qffiatem mg Imdgmark flees £91: fiscal Xgg 2993; Final Rule, 67 Fed.
`Reg. 70847, 70849 (November 27, 2002).
`
`The current fee schedule is accessible from:
`
`If the issue fee paid is the amount shown on the "Notice of Allowance and Fee(s) Due," but not the correct amount
`in view of the fee increase, a "Notice to Pay Balance of Issue Fee" will be mailed to applicant. In order to avoid
`processing delays associated with mailing of a "Notice to Pay Balance of Issue Fee," if the response to the Notice of
`Allowance and Fee(s) due form is to be filed on or after January 1, 2003 (or mailed with a certificate of mailing on or
`after January 1, 2003), the issue fee paid should be the fee that is required at the time the fee is paid. If the issue fee was
`previously paid, and the response to the "Notice of Allowance and Fee(s) Due" includes a request to apply a
`previously-paid issue fee to the issue fee now due, then the difference between the issue fee amount at the time the
`response is filed and the previously paid issue fee should be paid. See Manual of Patent Examining Procedure, Section
`1308.01 (Eighth Edition, August 2001).
`
`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. 05-03) Approved for use through 04/30/2004.
`
`Page 4 of 4
`
`APOTEX EX. 1006-004
`
`

`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Application No.
`
`AppIicant(s)
`
`09/711,272
`Examiner
`
`NORRIS ET AL.
`Art Unit
`
`Thomas McKenzie Ph.D.
`
`1624
`
`
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address--
`All claims being ailowable, 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 wili 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.
`
`
`
`Notice of Allowability
`
`
`
`
`1. X This communication is responsive to amendments of 5/28/03 .
`
`2. [Z The allowed claim(s) is/are 1-7 14-32 50 52-54 and 58-91.
`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) D All
`b) E] Some*
`c) E] None
`of the:
`
`1. U Certified copies of the priority documents have been received.
`
`2. E! Certified copies of the priority documents have been received in Application No. ___
`
`3. E] 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. E] Acknowledgment is made of a claim for domestic priority under 35 U.S.C. § 119(e) (to a provisional application).
`(a) D 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.
`
`
`
`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 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.
`
`
`
`
`
`8. [E CORRECTED DRAWINGS must be submitted.
`(a) IZ including changes required by the Notice of Draftsperson's Patent Drawing Review ( PTO-948) attached
`
`1) El hereto or 2) E to Paper No. Q.
`
`(b) E]
`
`including changes required by the proposed drawing correction filed
`
`, which has been approved by the Examiner.
`
`(c) [:]
`
`including changes required by the attached Examiners Amendment I Comment or in the Office action of Paper No.
`
`
`
`
`
` Identifying indicia such as the application number (see 37 CFR 1.84(c)) should be written on the drawings in the top margin (not the back)
`of each sheet. The drawings should be filed as a separate paper with a transmittal letter addressed to the Official Draftsperson.
`
`
` 9. CI DEPOSIT OF and/or INFORMATION about the deposit of BIOLOGICAL MATERIAL must be submitted. Note the
`
`
`attached Examinefs comment regarding REQUIREMENT FOR THE DEPOSIT OF BIOLOGICAL MATERIAL.
`
` Attachment(s)
`1E] Notice of References Cited (PTO-892)
`2[:] Notice of Informal Patent Application (PTO-152)
`3|] Notice of Drattperson's Patent Drawing Review (PTO-948)
`4|] Interview Summary (PTO—413), Paper No.___.
`5B Information Disclosure Statements (PTO-1449), Paper No. L21.
`6[:] Examiner's Amendmentlcomment
`7[:l Examiner's Comment Regarding Requirement for Deposit
`88 Examiner's Statement of Reasons for Allowance
`of Biological Material
`9[:l Other
`
`
`
`
`
`U.S. Patent and Trademanc Office
`
`PTO-37 (Rev. 04-01)
`
`Notice of Allowability
`
`Part of Paper No. 17
`
`APOTEX EX. 1006-005
`
`

`
`Application/Control Number: 09/711,272
`
`Page 2
`
`Art Unit: 1624
`
`Statement ofReasons for Allowance
`Claims 1-7, 14-32, 50, 52—54, and 58~9l are allowed. The following is an
`
`1.
`
`Examiner's statement of reasons for allowance: Applicants cancellation of claims
`
`55-57, made in amendment C, renders moot the objection made in point #6 of the
`
`final rejection. Applicants’ deletion of "prophylaxis" from claim 50 overcomes the
`
`enablement rejection made in point #10. Applicants‘ amendment to claim 63,
`
`specification they intent to treat tumors overcomes the indefiniteness rejection
`
`made in point #11. Applicants‘ amendments to claims 1, 3, and 5, specifying that
`
`the claimed compounds and compositions are of polymorph B only overcomes the
`
`art rejections made over Schnur (’498) in points #l3—#l6. Applicants state in lines
`
`15-19, page 16 that the material of Schnur ('498) is a mixture of polymorphs A and
`
`Purer materials necessarily differ from impure materials. The motivation to
`
`prepare purer material for human use is obvious. However, preparing crystalline
`
`modifications and polymorphs is an unpredictable art. There is no objective
`
`evidence establishing that any method was known to those skilled in process
`
`chemistry field whereby the claimed pure polymorph might have been synthesized.
`
`Claim 64 is drawn to treatment of specific cancers by any polymorph of the
`
`claimed compounds. These specific cancers are not found in Schnur ('498).
`
`Applicants claim 2 has X-ray data that differs in fine detail from that given
`
`in claim 1. Thus the limitations are not identical. The limitation in claim 3, "free
`
`APOTEX EX. 1006-006
`
`

`
`Application/Control Number: 09/711,272
`
`Page 3
`
`Art Unit: 1624 _
`
`of the A po1ymorph" does not exist in claim 1, Thus the claims are not identical
`
`and the objection made in point #4 of the Final rejection is withdrawn. For the
`
`same reason the objection made in point #5 is withdrawn. Claim 58 contains the
`
`limitation "a therapeutically effective amount". This limitation is not present in
`
`claim 5 and the objection made in point #7 is withdrawn. Upon further
`
`consideration, Applicants’ argument that a compound can be substantially free of
`
`the A polymorph without being substantially homogeneous is persuasive. Thus,
`
`the objection made in point #8 is withdrawn. Applicants‘ amendment to claim 14,
`
`restricting treatment to the enabled cancers, overcomes the rejection made in point
`
`#9. Applicants‘ amendment
`
`to claim 63, restricting treatment
`
`to the enabled
`
`cancers, overcomes the rejection made in point #12. 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."
`
`2.
`
`Please direct any inquiry concerning the status of this application or of the
`
`location of any papers to the Customer Service Office, whose telephone number is
`
`(703) 308-0197. The FAX number for the Customer Service Office is (703) 308-
`
`APOTEX EX. 1006-007
`
`

`
`Application/Control Number: 09/711,272
`Art Unit: 1624
`
`Page 4
`
`4407. All Post-Allowance correspondence concerning this application must be
`
`mailed to the following address:
`
`Box Issue Fee
`
`Commissioner for Patents
`
`Washington, DC 20231.
`Such correspondence (amendments under 37 CFR 1.312, IDS statements, formal
`
`drawings etc) also may be faxed to the Office of Patent Publications at (703) 308-
`
`5083. Sending Post-Allowance papers to Technology Center 1600 will only cause
`
`delays in matching papers with the case.
`
`{M ...4&u~r~ok J '“‘’‘/L
`
`Mukund Shah
`
`Supervisory Patent Examiner
`Art Unit 1624
`
`TCMCK
`June 9, 2003
`
`
`~““"‘j’fI'.1"_[M
`t»§i:t‘=2.l if: f
`31113,,
`
`
`{___,_......
`
`APOTEX EX. 1006-008