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`PART B - FEE(S) TRANSMITTAL
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`Complete and send this form, together with applicable fee(s), to: Mail Mail Stop ISSUE FEE
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`116469
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`01/27/2014
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`transmitted to the USPTO (571) 273-2885, on the date indicated below.
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`(Depositor's name)
`
`(Signature)
`
`(Date)
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`13/340,522
`
`12/29/2011
`
`Joseph J. Buggy
`
`25922-819.301
`
`7251
`
`TITLE OF INVENTION: USE OF INHIBITORS OF BRUTON'S TYROSINE KINASE (BTK)
`
`APPLN. TYPE
`
`ENTITY STATUS
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`ISSUE FEE DUE
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`PUBLICATION FEE DUE PREV. PAID ISSUE FEE
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`TOTAL FEE(S) DUE
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`DATEDUE
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`nonprovisional
`
`UNDISCOUNTED
`
`$960
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`$0
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`$0
`
`$960
`
`04/28/2014
`
`EXAMINER
`
`ART UNIT
`
`CLASS-SUBCLASS
`
`RAMACHANDRAN, UMAMAHESW ARI
`
`1627
`
`514-262100
`
`1. Change of correspondence address or indication of "Fee Address" (37
`CFR 1.363).
`0 Change of correspondence address (or Change of Correspondence
`Address form PTO/SB/122) attached.
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`(2) The name of a single firm (having as a member a
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`Authorized Signature _______________________ _
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`Registration No. ________________ _
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`PTOL-85 Part B (10-13) Approved for use through 10/31/2013.
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`OMB 0651-0033
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`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
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`Page 2 of3
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`
`UNITED STA IBS p A IBNT AND TRADEMARK OFFICE
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`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
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`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`13/340,522
`
`12/29/2011
`
`Joseph J. Buggy
`
`25922-819.301
`
`7251
`
`116469
`7590
`WSGR/Pharmacyclics, Inc.
`650 Page Mill Road
`Palo Alto, CA 94304
`
`01/27/2014
`
`EXAMINER
`
`RAMACHANDRAN, UMAMAHESW ARI
`
`ART UNIT
`
`PAPER NUMBER
`
`1627
`
`DATE MAILED: 01127/2014
`
`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
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`PTOL-85 (Rev. 02/11)
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`Page 3 of 3
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`
`
`Notice of Allowability
`
`Application No.
`13/340,522
`Examiner
`UMAMAHESWARI
`RAMACHANDRAN
`
`Applicant(s)
`BUGGY ET AL.
`AIA (First Inventor to
`Art Unit
`File) Status
`1627
`No
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address-(cid:173)
`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. [gl This communication is responsive to 1211712013.
`DA declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on ___ .
`2. D An election was made by the applicant in response to a restriction requirement set forth during the interview on __ ; the restriction
`requirement and election have been incorporated into this action.
`
`3. [gl The allowed claim(s) is/are 131and150 renumbered as 1-2 .. As a result of the allowed claim(s), you may be eligible to benefit from
`the Patent Prosecution Highway program at a participating intellectual property office for the corresponding application. For more
`information, please see htt.Q://www.usgto.gov/Qatents/init events/Q.Qh/indexjsg_ or send an inquiry to PPHfeedback@us2to.gov .
`4. D Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`*c) D None of the:
`a) D All
`b) D Some
`1. D Certified copies of the priority documents have been received.
`2. D Certified copies of the priority documents have been received in Application No. __ .
`3. D Copies of the certified copies of the priority documents have been received in this national stage application from the
`International Bureau (PCT Rule 17.2(a)).
`* Certified copies not received: __ .
`
`Applicant has THREE MONTHS FROM THE "MAILING DATE" of this communication to file a reply complying with the requirements
`noted below. Failure to timely comply will result in ABANDONMENT of this application.
`THIS THREE-MONTH PERIOD IS NOT EXTENDABLE.
`5. D CORRECTED DRAWINGS (as "replacement sheets") must be submitted.
`D 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. 0 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. D Notice of References Cited (PT0-892)
`2. D Information Disclosure Statements (PTO/SB/08),
`Paper No./Mail Date __
`3. D Examiner's Comment Regarding Requirement for Deposit
`of Biological Material
`4. D Interview Summary (PT0-413),
`Paper No./Mail Date __ .
`
`5. D Examiner's Amendment/Comment
`6. [gl Examiner's Statement of Reasons for Allowance
`7. D Other __ .
`
`U.S. Patent and Trademark Office
`PTOL-37 (Rev. 08-13)
`
`Notice of Allowability
`
`Part of Paper No./Mail Date 20140114
`
`
`
`Application/Control Number: 13/340,522
`Art Unit: 1627
`
`Page 2
`
`The present application is being examined under the pre-AIA first to invent
`
`provisions.
`
`DETAILED ACTION
`
`The office acknowledges Applicants' amendments and arguments in response to
`
`the office action dated 11 /1 /2013. Applicants' have cancelled claims 132-149 and have
`
`amended claim 131 and have added new claim 150. Applicants' amendments and
`
`arguments necessitated the withdrawal of 103 rejections and ODP rejection over
`
`13/153,291. Applicants filing of Terminal Disclaimer necessitated the withdrawal of the
`
`other ODP rejections. Claims 131 and 150 are allowable over the prior art and are
`
`renumbered as 1-2.
`
`REASONS FOR ALLOWANCE
`
`The claims of the instant application are towards a method for treating mantle cell
`
`lymphoma in an individual who has already received at least one prior therapy for
`
`mantle cell lymphoma comprising administering to the individual once per day between
`
`about 420 mg to about 840 mg of an oral dose of an inhibitor of Bruton's tyrosine kinase
`
`(Btk) having the structure:
`
`Claim 150 is limited to once per day oral dose of about 560 mg.
`
`
`
`Application/Control Number: 13/340,522
`Art Unit: 1627
`
`Page 3
`
`The closest prior art of record are Honigberg et al. (US 2008/0076921 ),
`
`PRNewswire (Dec 2009) and Pollyea et al. (Poster Abstracts, Dec. 3, 2009, 51 st ASH
`
`Annual Meeting and Exposition). Honigberg, teaches a genus of compounds that are
`
`useful in treating B-cell proliferative disorder and the compound of claim 131 (ibrutinib)
`
`is one of the compounds. However Honigberg do not explicilty teach or suggest a
`
`method of treating mantle cell lymphoma using the compound ibrutinib comprising
`
`adminstering the dosage amount as claimed once per day. Applicants have shown that
`
`the treatment of relapsed/refractory MCL with ibrutinib resulted in an overall response
`
`rate of 68 percent with 21 percent of patients achieving a complete response and 47%
`
`achieving a partial response in a phase II trial (see Science Daily article entitled "Drug
`
`shows surprising efficacy as treatment for Chronic Leukemia, Mantle Cell Lymphoma,
`
`Science Daily, .h .. t..t.p://WWWosciencedai157.colrdreleases/2013/06/130619195217;
`
`see also Byrd et al. NEJM, 2013 Aug 8;369(6):507-16). The estimated survival of the
`
`patients was high at 58% at 18 months. The response rate is considered remarkable
`
`given that that prior treatments for R/R MCL had only a 30% response rate. Such
`
`results are not taught or suggested by the cited art. Applicants have shown that ibrutinib
`
`demonstrates substantial improvement over existing therapies and this is not taught or
`
`suggested by the cited art. Such results are unexpected and hence the claims are
`
`allowable over the prior art. PRNewswire discloses a multicenter dose escalation phase
`
`I trial of orally administered Bruton's tyrosine kinase (Btk) inhibitor PCl-32765 in patients
`
`with relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL) or chronic lymphocytic
`
`leukemia (CLL) and the Poster abstract describe that PCl-32675 inhibits tumor growth
`
`
`
`Application/Control Number: 13/340,522
`Art Unit: 1627
`
`Page 4
`
`in B-cell non-Hodgkin's lymphoma models. (PCl-32675 is ibrutinib). However none of
`
`the cited references teach or suggest the use of ibrutinib in treating mantle cell
`
`lymphoma, the dosage amounts claimed in a patient who has already received at least
`
`one prior therapy for mantle cell lymphoma. The prior art do not anticipate, suggest or
`
`make obvious the claimed invention. Claims 131 and 150 are allowable and are
`
`renumbered as 1-2.
`
`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."
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to Umamaheswari Ramachandran whose telephone
`
`number is 571-272-9926. The examiner can normally be reached on M-F 8:30 AM -
`
`5:00 PM.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
`
`supervisor, Sreeni Padmanabhan can be reached on 571-272-0629. The fax phone
`
`number for the organization where this application or proceeding is assigned is 571-
`
`273-8300.
`
`
`
`Application/Control Number: 13/340,522
`Art Unit: 1627
`
`Page 5
`
`Information regarding the status of an application may be obtained from the
`
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`
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`
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`
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`
`/U. R./
`
`/SREENI PADMANABHAN/
`
`Supervisory Patent Examiner, Art Unit 1627
`
`