Transaction History Date 20t4-0-O
`1
`Date information retrieved from USPTO Patent
`Application Information Retrieval (PAIR)
`system records at www.uspto.gov
`
`Notice of Allowability
`
`Application No.
`13/340,522
`Examiner
`UMAMAHESWARI
`RAMACHANDRAN
`
`Applicant(s)
`BUGGY ET AL.
`Art Unit
`AIA (First Inventor to
`File) Status
`1627
`No
`
`-- The MAILING DATE of this communication appears on the cover sheet with the correspondence address--
`All claims being allowable, PROSECUTION ON THE MERITS IS (OR REMAINS) CLOSED in this application. If not included
`herewith (or previously mailed), a Notice of Allowance (PTOL-85) or other appropriate communication will be mailed in due course. THIS
`NOTICE OF ALLOWABILITY IS NOT A GRANT OF PATENT RIGHTS. This application is subject to withdrawal from issue at the initiative
`of the Office or upon petition by the applicant. See 37 CFR 1.313 and MPEP 1308.
`1. ® This communication is responsive to 1/30/2014.
`Q A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`2. O An election was made by the applicant in response to a restriction requirement set forth during the interview on
`requirement and election have been incorporated into this action.
`
`; the restriction
`
`3. ® The allowed claim(s) is/are 131. 150 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 htto://www.uspto.gov/patents/init events/pph/irndex.isp or send an inquiry to PPHfeedback@usto.aov .
`4. Q Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`b) O Some
`*c) O None of the:
`a) ] All
`1. O Certified copies of the priority documents have been received.
`2. O Certified copies of the priority documents have been received in Application No.
`3. O 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. O CORRECTED DRAWINGS ( as "replacement sheets") must be submitted.
`O including changes required by the attached Examiner's Amendment / Comment or in the Office action of
`Paper No./Mail Date
`Identifying indicia such as the application number (see 37 CFR 1.84(c)) should be written on the drawings in the front (not the back) of
`each sheet. Replacement sheet(s) should be labeled as such in the header according to 37 CFR 1.121(d).
`6. O 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. O Notice of References Cited (PTO-892)
`2. [
`Information Disclosure Statements (PTO/SB/08),
`Paper No./Mail Date
`3. O Examiner's Comment Regarding Requirement for Deposit
`of Biological Material
`4. U Interview Summary (PTO-413),
`Paper No./Mail Date
`
`5. O Examiner's Amendment/Comment
`6. ] Examiner's Statement of Reasons for Allowance
`
`7. O Other
`
`I raoemarK UTTICK
`U ~ raleni ana
`lOffice
`U S Patent an
`I raaemar
`PTOL-37 (Rev. 08-13)
`
`Notice of Allowability
`Notice of Allowability
`
`Pan of Paper No/Mail Date 20140311
`Part of Paper No./Mail Date 20140311
`
`Exhibit 2009 Page 001
`
`Pharmacyclics LLC - Ex. 2009
`Coalition for Affordable Drugs IV LLC v. Pharmacyclics LLC
`Case IPR2015-01076
`
`

`

`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
`
`A request for continued examination under 37 CFR 1.114, including the fee set
`
`forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this
`
`application is eligible for continued examination under 37 CFR 1.114, and the fee set
`
`forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action
`
`has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on
`
`1/30/2014 has been entered.
`
`Claims 131 and 150 are allowed and are renumbered as 1, 2.
`
`Application Priority
`
`This application filed 12/29/2011 is a continuation of 13153317, filed 06/03/2011,
`
`Claims Priority from Provisional Application 61351130, filed 06/03/2010, Claims Priority
`
`from Provisional Application 61351655, filed 06/04/2010, Claims Priority from
`
`Provisional Application 61351793, filed 06/04/2010, Claims Priority from Provisional
`
`Application 61351762, filed 06/04/2010, Claims Priority from Provisional Application
`
`61419764, filed 12/03/2010, Claims Priority from Provisional Application 61472138, filed
`
`04/05/2011.
`
`Exhibit 2009 Page 002
`
`

`

`Application/Control Number: 13/340,522
`Art Unit: 1627
`
`Page 3
`
`Information Disclosure Statement
`
`The information disclosure statement (IDS) filed on 1/30/2014 and 2/7/2014 are
`
`in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being
`
`considered by the Examiner.
`
`REASONS FOR ALLOWANCE
`
`The reasons for allowance are the same as stated in the office action dated
`
`1/27/2014.
`
`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.
`
`Exhibit 2009 Page 003
`
`

`

`Application/Control Number: 13/340,522
`Art Unit: 1627
`
`Page 4
`
`Information regarding the status of an application may be obtained from the
`
`Patent Application Information Retrieval (PAIR) system. Status information for
`
`published applications may be obtained from either Private PAIR or Public PAIR.
`
`Status information for unpublished applications is available through Private PAIR only.
`
`For more information about the PAIR system, see http://pair-direct.uspto.gov. Should
`
`you have questions on access to the Private PAIR system, contact the Electronic
`
`Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a
`
`USPTO Customer Service Representative or access to the automated information
`
`system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
`
`/UMAMAHESWARI RAMACHANDRAN/
`
`Examiner, Art Unit 1627
`
`Exhibit 2009 Page 004
`
`

`

`-
`U d t
`n er
`
`
`...
`h*
`P
`e aperwor
`
`i,,.;,. A
`k. R d D
`e ucton
`
`Substitute for form 1449/PTO
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`(Use as many sheets as necessar
`
`Application Number
`Filing Dale
`First Named Invenlor
`A Unit
`Ar Unit
`Ixamincr Name
`
`PTO/SB/08a (07-09)
`Approved for use through 07/31/2012. OMB 0651-0031
`U.S Patent and Trademark Office: U.S. DEPARTMENT OF COMMERCE
`cter
`.......
`f . 199) .r
`i~~itiiiatiiucr.icuousariuslias~ira
`ii
`i~M..C~~VI
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`c o ~. no persons requeU Lu respond to a cullection o lnlformatton unless It conlams a vald OMB control number.
`Complete if Known
`13/340,522
`December 29, 2011
`Joseph J. BUGGY
`1627
`1627
`Umamaheswari
`RAMANCHANDRAN
`25922-819.301
`
`Sheet
`
`1
`
`of
`
`10
`
`Attorney Docket Number
`
`Examiner
`Initials*
`
`Cite
`No.1
`
`1.
`2.
`
`Examiner
`Initials*
`
`Cite
`No.i
`
`3.
`4.
`5.
`6.
`7.
`8.
`9.
`10.
`
`U.S. PATENT DOCUMENTS
`Publication Date
`Name of Patentee or
`MM-DD-YYYY
`Applicant of Cited Document
`
`Document Number
`Number-Kind Code" ('f known)
`US-2010-0016296
`US-2010-0185419
`
`1/21/2010
`7/22/2010
`
`Singh et al.
`Singh et al.
`
`U.S. UNPUBLISHED PATENT DOCUMENTS
`Filing Date
`Name of Applicant of Cited
`MM-DD-YYYY
`Document
`
`Document Number
`Number-Kind Code (i/fknown)
`US-14/033,344
`US-14/069,222
`US-14/073,543
`US-14/073,594
`US-14/079,508
`US-14/080,640
`US-14/080,649
`US-14/152,886
`
`9/20/2013
`Honigberg et al.
`10/31/2013 Honigberg et al.
`11/6/2013
`Honigberg et al.
`11/6/2013
`Honigberg et al.
`11/14/2013 Honigberg et al.
`11/14/2013 Honigberg et al.
`11/14/2013 Honigberg et al.
`1/10/2014
`Honigberg et al.
`
`Pages, Columns, Lines, Where
`Relevant Passages or Relevant
`Figures Appear
`
`Pages, Columns, Lines, Where
`Relevant Passages or Relevant
`Figures Appear
`
`Examiner
`Initials*
`
`Cite
`No.
`
`Foreign Patent Document
`
`FOREIGN PATENT DOCUMENTS
`Publication Date
`Name of Patentee or
`MM-DD-YYYY
`Applicant of Cited Document
`Coutry Code' Numbed - Kind Code (r ou,,
`
`Pages, Column,
`tinms,
`Where Relevant Passages
`Or Relevant Figures Appear
`
`Examiner
`Date
`/Umamaheswari Rarnachandran/ (03/11/2014
`Considered
`Sinature
`*EXAMINER: mithal it reerence considered whether or not citati on ir i olornice with b ll'
`609 Draw line through eamcion i
`not mi cnfornmance and not considered ilchde copy
`of this form with next communlcatlon to applicant. iApplcant's unique citation designation number (optional). 2See Kinlds Codes of IUSTO Patent Documents at e..tWcfis.9.
`y
`MPEP
`901.04. 3Enter
`Office that issued the document, by the two-lettel code (WIPO Standard ST.3). 'For Japanese patent documents, the indication of the yea of the reign of the Empeior must
`precede the serial number of the patent docmnent. 'Kmd of docunent by the appiopiiate symbols as indicated on the document under WVPO Standard ST.16 If possible. 'Applicant is to place a
`check mark here if English language Translatlion is attached.
`This collection of information is required by 37 CFR 1.97 and 1.98. The information is required to obtain or retain a benefit by the public which is to file (and by the USPTO to process) an
`application. Confidentialhty is governed by 35 U.S.C. 122 and 37 CFR 1.14. This collection is estimated to take 2 hours to complete, including gathering, preparing, and submitting the
`completed application form to the USPTO. Time will vary depending upon the individual case. Any comments on the amount of tune you requie to complete this form and/or suggestions fot
`reducing this burden, lhould be sent to the Chief Inloniaton Olkhie, U.S. Patent and Trademnak Office, P.O. Box 1450, Alexandr, VA 22313-1450. DO NOT SEND FEES OR COvIPLETED
`ADDRESS. SLEN TO: Commissioner for Patents, P.O. Box 1450, Alexandia, VA 22313-1450.
`FORMS 1'I1'O'IS
`Ij yo nteed i sta ce, iT i compln/t g the toou, call I-800-PTO-9199 (1-800-78h-9199) and select oltio: 2.
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH. /U.R,/
`
`Exhibit 2009 Page 005
`
`

`

`PTO/SB/08a (07-09)
`Approved for use through 07/3 1/2012. OMB 0651-0031
`U.S. Patent and Trademark Office: U.S. DEPARIM ENT O01 COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons required to respond to a collection of information unless it contains a valid OMB control number.
`Complete if Known
`13/340,522
`December 29, 2011
`Joseph J. BUGGY
`1627
`Umamahcswari
`RAMANCHANDRAN
`25922-819.301
`
`Substitute for form 1449/PTO
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`(Use as many sheets as necessart)
`
`Application Number
`Filing Date
`First Named Inventor
`Art Unit
`Examincr Name
`
`Sheet
`
`2
`
`of
`
`10
`
`Attorney Docket Number
`
`Examiner
`Initials*
`
`Cite
`No.'
`11.
`
`NON PATENT LITERATURE DOCUMENTS
`Include name of the author (in CAPITAL LETTERS), title of the article (when appropriate), title of the
`item (book, magazine, journal. serial, symposium, catalog, etc.), date, page(s), volume-issue number(s),
`publisher, city and/or country where published.
`U.S. Serial Number No. 13/003,811 Final Office Action mailed October 11, 2013
`
`T
`
`12.
`
`13.
`
`14.
`
`15.
`
`16.
`
`17.
`
`18.
`
`19.
`
`20.
`
`21.
`
`22.
`
`23.
`
`24.
`
`25.
`
`26.
`
`27.
`
`28.
`
`29.
`
`U.S. Serial Number No. 13/542,440 Non-Final Office Action mailed October 31, 2013
`
`U.S. Serial Number No. 13/450,158 Non-Final Office Action mailed October 31, 2013
`
`U.S. Serial Number No. 13/606,949 Non-Final Office Action mailed October 29, 2013
`
`U.S. Serial Number No. 12/907,759 Final Office Action mailed November 08, 2013
`
`U.S. Serial Number No. 13/335,719 Final Office Action mailed November 08, 2013
`
`U.S. Serial Number No. 13/340,409 Final Office Action mailed November 12, 2013
`
`U.S. Serial Number No. 13/249,066 Office Action mailed December 11, 2013
`
`EP 12166305.8 Examination Report dated 3 December 2013
`
`U.S. Serial Number No. 12/907,759 Office Action mailed December 31, 2013
`
`U.S. Serial Number No. 13/153,291 Final Office Action mailed January
`
`03, 2014
`
`U.S. Serial Number No. 13/542,440 Office Action mailed January 07, 2014
`U.S. Serial Number No. 13/341,708 Office Action mailed January 22, 2014
`PRNewswire, "Update on Preclinical Finding and Development Timeline for PCI-
`45292", March 2, 2011
`WITZIG et al. "Detection of myeloma cells in the peripheral blood by flow cytometry."
`Cytometry (Communuications in Clinical Cytometry), 26:113-120 (1996)
`LICHTMAN "Batltling the hematological malignancies: The 200 years' war." The
`Oncologist, 13:126-138 (2008)
`U.S. Serial Number No. 13/153,317 Final Office Action mailed January 23, 2014
`CHANG et al. "Ig ress of CDI9+CD5+ cells into peripheral blood following treatment
`with the Bruton tyrosine kinase inhibitor inbrutinib in mantel cell lymphoma patients",
`Blood, 122:2412-2424 (2013).
`Janssen Research and Development, LLC. A study to assess the absolute bioavailability
`
`Examiner
`Date
`/Uimamaheswari Ramachran dran ! 03/11/2014)
`Sinature
`Considered
`609 Draw line through cration not in croform..ce and not considered include co py
`*EXAhINER: butil tJ Jererence considered, wherher or not cranon is rir conformance wth MP EP
`t
`ofh tform with next communication to applicant. 'Applcant's uniqeir cltaohn designation number (opt onal). 2Se Kinds Codes of USPTO Patent Documents at wy a.usL .'.C or MPEP
`code (WIPO Standard ST.3). 'For Japanese patent documents, the indication of the year of the leign
`901.04. 'Enter Office that issued the document, by the two-lettel
`of the Emperor must
`precede the serial number of the patent document. Kind of document by the appropriate symbols as indicated on the document under WEPO Standard ST.16 if possible. 'Applicant is to place a
`check mark here if English language Translation is attached.
`This collection of information is required by 37 CFR 1.97 and 1.98. The inform ation is required to obtain or retain a benefit by the public which is to file (and by the USPTO to process) an
`application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.14. This collection is estimated to take 2 hours to complete, inchldmg gathering, preparing, and submitting the
`completed application form to the USPTO. Tune will vary depending upon the individual case. Any comments on the amount of time you require to complete this form and/or suggestions for
`reducing this burden, should be sent to the Cluef Infomiation Oticer, U.S. Patent and Tradeark Office, P.O. Bux 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COiPLETED
`FOIui.S TO' HIS ADDRESS. SEND 'rO: Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`I)jyou reed osrtale rn competring the form, call -800-PTO-9199 (1-800-786-9199) and selectr opion 2
`
`-2-
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/U.R./
`
`Exhibit 2009 Page 006
`
`

`

`PTO/SB/08a (07-09)
`Approved for use through 07/31/2012. OMB 0651-0031
`U.S. Patent and Trademark Office: U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995. no persons required to respond to a collection of information unless it contains a valid OMB control number.
`Complete if Known
`13/340,522
`December 29, 2011
`Joseph J. BUGGY
`1627
`Umamahcswari
`RAMANCHANDRAN
`25922-819.301
`
`Substitute for form 1449/PTO
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`(Use as many sheets as necessary)
`
`Application Number
`Filing Date
`First Named Inventor
`Art Unit
`Examiner Name
`
`Sheet
`
`3
`
`of
`
`10
`
`Attorney Docket Number
`
`Examiner
`Initials*
`
`Cite
`No.'
`
`30.
`
`31.
`
`32.
`
`33.
`
`34.
`
`35.
`
`T2
`
`NON PATENT LITERATURE DOCUMENTS
`Include name of the author (in CAPITAL LETTERS), title of the article (when appropriate), title of the
`item (book, magazine, journal. serial, symposium, catalog, etc.), date, page(s), volune-issue number(s),
`publisher, city and/or country where published.
`of Oral PCI-32765 and the effect of grapefruit juice on the bioavailability of PCI-32765
`in healthy participants. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National
`Library of Medicine (US) 2013 May 28- [cited 2013 Nov 22]. Available from:
`http://clinicaltrials.gov/ct2/show/study/NCT01866033 NLM Identifier: NCT01866033.
`Janssen Research and Developmenl, LLC. A study to determine the absorption,
`metabolism, and routes of excretion of (14C) radiolabeled ibrutinib in healthy male
`participants. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of
`Medicine (US). 2012 Aug 9- [cilced 2013 Nov 22]. Available from:
`htlp://clinicaltrials.gov/ct2ishow/NCT01674322 NLM Identifier: NCT01674322.
`Ohio State University Comprchcnsive Cancer Center. PCI-32765 (Ibrutinib) in treating
`patients with relapsed or refractory chronic lymphocytic leukemia, small lymphocytic
`lymphoma, or B-cell prolymphocytic leukemia. In: ClinicalTrials.gov [Internet].
`Bethesda (MD): National Library of Medicine (US). 2012 Apr 23- [cited 2013 Nov 22].
`Available from: http://clinicaltrials.gov/ct2/show/NCT01589302 NLM Identifier:
`NCT01589302.
`Janssen Research and Development, LLC. A study of PCI-32765 (Ibrutinib) in patients
`with refractory follicular lymphoma. In: ClinicalTrials.gov [Internet]. Bethesda (MD):
`National Library of Medicine (US). 2013 Jan 25- [cited 2013 Nov 22]. Available from:
`http://clinicaltrials.gov/cl2ishow/NCT01779791 NLM Identifier: NCTO 1779791.
`National Cancer Institute (NCI). Rituximab and bendamustine hydrochloride, rituximab
`and ibrutinib, or ibrhtinib alone in treating older patients with previously untreated
`chronic lymphocytic leukemia. In: ClinicalTrials.gov [Internet]. Bethesda (MD):
`National Library of Medicine (US). 2013 Jun 24- [cited 2013 Nov 22]. Available from:
`http://clinicaltrials.gov/ct2/show/NCT01886872 NLM Identifier: NCT01886872.
`Janssen Research and Development, LLC. A long-term extension study of PCI-32765
`(Ibrutinib). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of
`Medicine (US). 2013 Mar 04- [cited 2013 Nov 22]. Available from:
`http://clinicaltrials.gov/ct2/show/NCT01804686 NLM Identifier: NCT01804686.
`Janssen Research and Development, LLC. A study to assess the effect of ketoconazole
`on the pharmacokinetics of ibrutinib in healthy participants. In: ClinicalTrials.gov
`[Internet]. Bethesda (MD): National Library of Medicine (US). 2012 Jun 18- [cited
`2013 Nov 22]. Available from: http://clinicaltrials.gov/ct2/show/NCT01626651 NLM
`
`Examiner
`Date
`/Umanaheswari Rariachandran/ (03/11/2014) Considered
`Si,,gature
`a i coou,,ntnce wth.~ l1609 Durw oe th.rough
`*EXAMINER: I tial rJ reference c oli'idered r heheror aot rao
`,mioll i Hot i confonance and not considered include coy
`.
`r
`of tlle form with ne.xt conmmincaltion to apphcanr. 1Apph an' Ilnlque citlon designation numbel (opillonal). Scc Kinds Codes of USPTO Palent DocinIents at y,! an 2-~ tL. r
`or M 'EP
`901I.04. 'Enter Office that issued the document, by thi two-lette code (WIPO Standard ST3). ''For Japanese patent documents di.
`the Indication of the year of the reign of the Emperor must
`precede the serial number of the patent docurnent. 'Kind of docunent by the appropriate symbols as indicated on the document under WIPO Standard ST.16 if possible. "Applicant is to place a
`check malk here if English language Translation is attached.
`This collection of informnation is required by 37 (':R 1.97 and 1.98. The infi ormation is requred to obtain or letaln
`a benefit by the pubhic which Is to tile (and by the USPt'O to process) an
`apphlcation. Confidentiality is governed by 35 U.S.C. 122 and 37 (FR 1.14 This collection is estimated to take 2 hours to conplete. includdmg gathering, preparing, and subrlutting the
`completed appication form to the USPTI'O. Tiune will ai dening uplonl the in( I dual case. Any conaimmnts on thie alont of rtune you requne to ciomplete this formi and/oi suggestions for
`this burdenr should be sent to thi Ciuef Inf r nlalon 0fei1
`reducmng
`. lS I alenl iand Tiaderark Office. P.O. Box 1450. Alexndoi a, VA 22313-1450. DO NOT SEND FEES OR COMPLETED
`FORtMS TO' S1111 ADDIRESS. SEND 'tO: Commissioner lbr Patents, P1.O. tBo 1450. Alexanodria, VA 22313-1450.
`1//I on need sii.lt it inl, cni rlin/
`,
`rth mi, rol I-800-PTO-9/99 (-800-786-9
`
`
`
`t99) ntd vleet on iaio: 2
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH. /U.R./
`
`Exhibit 2009 Page 007
`
`

`

`PTO/SB/08a (07-09)
`Approved for use through 07/31/2012. OMB 0651-0031
`U.S. Patent and Trademark Office: U.S. DEPARIMENT OF COMMERCE
`required to respond to a collection of information unless it contains a valid OMB control number.
`Complete ifKKnown
`13/340,522
`
`Under the Paperwork Reduction Act of 1995. no persons
`
`Substitute for form 1449/PTO
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`(Use as many sheets as necessary)
`
`Application Number
`Filing Date
`First Named Inventor
`Art Ullit
`Art Unit
`Examiner Name
`
`December 29, 2011
`Joseph J. BUGGY
`1627
`1627
`Umamaheswari
`RAMANCHANDRAN
`25922-819.301
`
`Sheet
`
`4
`
`of
`
`10
`
`Attorney Docket Number
`
`Examiner
`Initials*
`
`Cite
`No.'
`
`36.
`
`37.
`
`38.
`
`39.
`
`40.
`
`41.
`
`T2
`
`NON PATENT LITERATURE DOCUMENTS
`Include name of the author (in CAPITAL LETTERS), title of the article (when appropriate), title of the
`item (book, magazine, journal, serial, symposium, catalog, etc.), date, page(s), volume-issue number(s),
`publisher, city and/or country where published.
`Identifier: NCT01626651.
`Janssen Research and Development, LLC. A study on the Bruton's tyrosine kinase
`inhibitor, PCI-32765 (Ibrutinib), in combination with rituximab, cyclophosphamide,
`doxorubicin, vincristine, and prednisone in patients with newly diagnosed non-germinal
`center B-cell subtype of diffuse large B-cell lymphoma. In: ClinicalTrials.gov
`[Internet]. Bethesda (MD): National Library of Medicine (US). 2013 May 14- [cited
`2013 Nov 22]. Available from: http://clinicaltrials.gov/ct2/show/NCTO 1855750 NLM
`Identifier: NCT01855750.
`Janssen Research and Development, LLC. A pharmacokinetic study in healthy
`participants to assess the pharmacokinctics and safety of a supratherapeutic dose of
`PCT-32765 (Ibrutinib) capsule and solution fommulations administered with food. In:
`ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2013
`Aug 19- [cited 2013 Nov 22]. Available from:
`http://clinicaltrials.gov/ct2/show/NCT01969266 NLM Identifier: NCT01969266.
`National Center Institute (NCI). Lenalidomide and Ibrutinib in treating patients with
`relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
`In: ClinicalTrials.gov [hnlernet]. Bethesda (MD): National Library of Medicine (US).
`2013 Jun 24- [cited 2013 Nov 22]. Available from:
`http://clinicaltrials.gov/ct2/showiNCT01886859 NLM Identifier: NCT01886859.
`Janssen Research and Development, LLC. A study to detcrmine the effect of food on
`the pharmacokinctics of PCI-32765. In: ClinicalTrials.gov [Internet]. Bethesda (MD):
`National Library of Medicine (US). 2013 Mar 04- [cited 2013 Nov 22]. Available frontm:
`http://clinicaltrials.gov/ct2/showiNCT0 1820936 NLM Identificr: NCT01820936.
`Janssen Research and Development, LLC. A study comlbining Ibrutinib with rituximab,
`cyclophosphamide, doxorubicin, vincristine, and prednisone in patients with CD20-
`positive B-cell non Hlodgkin lymphoma. In: ClinicalTrials.gov [Internet]. Bethesda
`(MD): National Library of Medicine (US). 2012 Mar 30- [cited 2013 Nov 22].
`Available from: http://clinicaltrials.gov/ct2/show/NCT( 1569750 NLM Identifier:
`NCT01569750.
`National Cancer Institute (NCI). Rituximab, lenalidomide, and ibrutinib in treating
`patients with previously untreated stage II-IV follicular lymphoma. In:
`ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2013
`
`Examiner
`Date
`i/Umanaheswari Ramachandran/ (03/11/2014) Considered
`Signature
`*EXAMINER: lit:al iJ reference considered, whether oria n citaioi is ri co
`withtMPEL' 609. Draw e through ciatoon ir not im coIormance aid not consrdered include copy
`i'ormance
`of this form with next commmnication to applicant. 'Apphcants unique citahon designation number (optional). 2Sec Kinds Codes of USPTO Patent Documents at w ,a.r it..
`or MPEP
`901.04. 'Enter Office that issued tdie document, by the two-letter code (WPO Standard ST.3). 'For Japanese patent documents, the indication of the year of the reign of the Emperor must
`plecede the serial number of the patent document.
`'Kmd of document by the appropriate
`symbols as indicated on the document under WIPO Standard ST.16 if possible. °Apphcant is to place a
`check mark here if English language Translation is attached.
`This collection of informatlon
`is required by 37 CFR 1.97 and 1.98. The mfommation is required to obtain or retain a benefit by the pubic which is to file (and by the USPTO to process) an
`application. Confidentalty is governed by 35 U.S.C. 122 and 37 CFR 1.14. This collection is estumated to take 2 hours to complete, including gathering, preparng, and submitting the
`completed application form to the USPTO. Time will vary depending upon the individual case. Any comments on the amount of time you require to complete this form and/or suggestions for
`reducing this burden, should be sent to the Chif Information
`Officei, U.S. Patent and Tradeirak Office, P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR CON PLETED
`FORIMS TOr THIS ADDRESS. SEND TO: Commissioner for Patents, P.O. Box 1450, Alexanlria, VA 22313-1450.
`I/ you need asista:oce tn nompleting thefirm, call 1-800-PTO-9199 (1-800-786-9199) and select opror 2
`
`-4
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/U.R.i
`
`Exhibit 2009 Page 008
`
`

`

`PTO/SB/08a (07-09)
`Approved for use through 07/31/2012. OMB 0651-0031
`U.S. Patent and Trademark Office: U.S. DEPARTMENT OF COMMERCE
`
`Substitute for form 1449/PTO
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`(Use as many sheets as necessary
`
`Application Number
`
`Filing Date
`First Named Inventor
`Unit
`Art Uit
`Examiner Name
`
`Sheet
`
`5
`
`of
`
`10
`
`Attorney Docket Number
`
`Comnplete ifKnown
`13/340,522
`
`December 29, 2011
`Joseph J. BUGGY
`1627
`1627
`Umamahcswari
`RAMANCHANDRAN
`25922-819.301
`
`Examiner
`Initials*
`
`Cite
`No.'
`
`42.
`
`43.
`
`44.
`
`45.
`
`46.
`
`47.
`
`T2
`
`NON PATENT LITERATURE DOCUMENTS
`Include name of the author (in CAPITAL LETTERS), title of the article (when appropriate), title of the
`item (book, magazine. journal, serial, symposium, catalog, etc.), date, page(s), volume-issue number(s).
`publisher, city and/or country where published.
`Apr 09- [cited 2013 Nov 22]. Available from:
`http://clinicaltrials.gov/ct2/show/NCT01829568 NLM Identifier: NCT01829568.
`Janssen Research and Development, LLC. A study of PCI-32765 (Ibrutinib) in
`combination with either bendamustine and rituximab or rituximab, cyclophosphamide,
`doxorubicin, vincristine, and prednisone in patients with previously treated indolent
`non-Hodgkin lymphoma. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National
`Library of Medicine (US). 2013 Oct 28- [cited 2013 Nov 22]. Available from:
`http://clinicaltrials.gov/ct2/show/NCT01974440 NLM Identifier: NCT01974440.
`Janssen Research and Development, LLC. A study of the Bruton's tyrosine kinase
`inhibitor PCI-32765 (Ibrutinib) versus rituximab in patients with relapsed or refractory
`chronic lymphocytic leukemia/small lymphocytic lymphoma. In: ClinicalTrials.gov
`[Internet]. Bethesda (MD): National Library of Medicine (US). 2013 Oct 25- [cited
`2013 Nov 22]. Available friom: http:!/clinicaltrials.gov/ct2/show/NCT01973387 NLM
`Identifier: NCT01973387.
`Pharmacyclics, Inc. Study of the Bnuton's tyrosine kinase inhibitor in combination with
`carfilzomib (Kyprolis), in subjects with relapsed or relapsed and refractory multiple
`myeloma. In: ClinicalTrials.gov [Internel]. Bethesda (MD): National Library of
`Medicine (US). 2013 Sept 27- [cited 2013 Nov 22]. Available from:
`http://clinicaltrials.gov/ct2ishow/NCT01962792 NLM Identifier: NCT01962792.
`Dana-Farber Cancer Institute. Ibrutinib (PCI-32765) in Waldenstrom's
`Macroglobulincmia. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library
`of Medicine (US) 2012 May 17- [cited 2013 Nov 22]. Available from:
`http://clinicaltrials.gov/ ct2ishow/NCT01614821 NLM Identifier: NCT01614821.
`National Cancer Institule (NCI). Ibrutinib in treating patients with relapsed or refractory
`follicular lymphoma. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library
`of Medicine (US). 2013 May 06- [cited 2013 Nov 22]. Available fiom:
`hblp://clinicaltrials.gov/c12ishow/'NCT01849263 NLM Identifier: NCT01849263.
`National Cancer Institute (NCI). Lenalidomide and ibrutinib in treating patients with
`relapsed or refractory B-Cell non-Hodgkin lymphoma. In: ClinicalTrials.gov [Internel].
`Bethesda (MD): National Library of Medicine (US). 2013 Sept 27- [cited 2013 Nov
`22]. Available from: http://clinicaltrials.gov/ct2/show/NCT01955499 NLM Identifier:
`NCT01955499.
`
`'12
`4
`Examiner
`Date
`Umamaheswari Ramachandrani (03/11/2014) Considered
`Sinatre
`*EXAMIVER: Imtial ij rene coonsdered, whether or not citaon is mi cotroromance with MPEI 609 Draw line through cuiation ij not in cor man:ce and notr considered Include copy
`ofthis form with next communicaton to arpplicant. 'Apprcant s unique citation designation number (optional). 2See Kinds Codes of TSPTO Patent Documents at yv..pito_
`or MPEP
`901.04. Enter Office that issued the document, by the two-lettel
`code (W1PO Standard ST.3). 'For Japanese patent documents, the indication of die year of the reign of the Emperor must
`precede the serial number of the patent document. Kind of document by the appropriate symbols as indicated on the document under WIPO Standard ST.16 if possible. Applicant is to place a
`check mark here if English language Translation
`is attached.
`This collection of information is required by 37 CFR 1.97 and 1.98. The information is required to obtain or retain a benefit by the public which is to file (and by the USPTO to process) an
`application. Confidentahtity is governed by 35 U.S.C. 122 and 37 CFR 1.14. This collection is estimated to take 2 hours to complete, including gathering, preparing, and submitting the
`completed application form to the USPTO. Tone will vary depending upon the ndividual case. Any comments on the amount of tune you require to complete tins form and/or suggestions for
`teducing this burden, should be sent to the Chief Infainration Offiee, U.S. Patent and Tradeark Office, P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED
`FORMS TO TlIS ADDIRESS. SEND TO: Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`If you need assista:ce mI completing the form, call I-800-PTO-9199 (1-800-786-9199) and select oplron 2.
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH. !U.R./
`
`Exhibit 2009 Page 009
`
`

`

`PTO/SB/08a (07-09)
`Approved for use through 07/31/2012. O2IB 0651-0031
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995. no persons required to respond to a collection of information unless it contains a valid OMB control number.
`Complete if Known
`13/340,522
`December 29, 2011
`Joseph J. BUGGY
`1627
`Umamahcswari
`RAMANCHANDRAN
`25922-819.301
`
`Substitute for form 1449/PTO
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`(Use as many sheets as necessary )
`
`Application Number
`Filing Date
`First Named Inventor
`Art Unit
`Examiner Name
`
`Sheet
`
`6
`
`of
`
`10
`
`Attorney Docket Number
`
`Examiner
`Initials*
`
`Cite
`No.'
`48.
`
`49.
`
`50.
`
`51.
`
`52.
`
`53.
`
`54.
`
`T
`
`NON PATENT LITERATURE DOCUMENTS
`Include name of the author (in CAPITAL LETTERS), title of the article (when appropriate), title of the
`item (book. magazine. journal. serial, symposium, catalog, etc.), date. page(s), volume-issue number(s),
`publisher, city and/or country where published.
`M.D. Anderson Cancer Center. Pilot study to determine effects of the Btk inhibitor PCI-
`32765 on leukemia cell kinetics and trafficking, using heavy water labeling in subjects
`with CLL and SLL. It: ClinicalTrial