PTO/SB/30EFS (07-09)
`Doc code: RCEX
`Approved for use through 07312012. OMB 0651-ER0031
`Doc description: Request for Continued Examination (RCE)
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`REQUEST FOR CONTINUED EXAMINATION(RCE)TRANSMITTAL
`(Submitted Only via EFS-Web)
`
`Application
`Number
`
`13/340,522
`
`Filing
`Date
`
`2011-12-29
`
`Docket Number 25922-819.301
`(if applicable)
`
`Art
`Unit
`
`1627
`
`ph J. BUGGY
`
`First Named
`Inventor
`This is a Request for Continued Examination (RCE) under 37 CFR 1.114 of the above-identified application.
`Request for Continued Examination (RCE) practice under 37 CFR 1.114 does not apply to any utility or plant application filed prior to June 8,
`1995, or to any design application. The Instruction Sheet for this form is located at WWW.USPTO.GOV
`
`Examiner
`Name
`
`RAMACHANDRAN, UMAMAHESWARI
`
`SUBMISSION REQUIRED UNDER 37 CFR 1.114
`
`Note: If the RCE is proper, any previously filed unentered amendments and amendments enclosed with the RCE will be entered in the order
`in which they were filed unless applicant instructs otherwise. If applicant does not wish to have any previously filed unentered amendment(s)
`entered, applicant must request non-entry of such amendment(s).
`Previously submitted. If a final Office action is outstanding, any amendments filed after the final Office action may be considered as a
`Q submission even if this box is not checked.
`
`[ Consider the arguments in the Appeal Brief or Reply Brief previously filed on
`
`[] Other
`
`x Enclosed
`
`[
`
`[
`
`Amendment/Reply
`
`Information Disclosure Statement (IDS)
`
`] Affidavit(s)/ Declaration(s)
`
`D Other
`
`Suspension of action on the above-identified application is requested under 37 CFR 1.103(c) for a period of months
`O (Period of suspension shall not exceed 3 months; Fee under 37 CFR 1.17(i) required)
`
`MISCELLANEOUS
`
`Other
`
`x
`
`The RCE fee under 37 CFR 1.17(e) is required by 37 CFR 1.114 when the RCE is filed.
`The Director is hereby authorized to charge any underpayment of fees, or credit any overpayments, to
`Deposit Account No
`232415
`
`SIGNATURE OF APPLICANT, ATTORNEY, OR AGENT REQUIRED
`
`FEES
`
`[] Patent Practitioner Signature
`
`[
`
`Applicant Signature
`
`EFS - Web 2.1.15
`
`Exhibit 2015 Page 001
`
`Pharmacyclics LLC - Ex. 2015
`Coalition for Affordable Drugs IV LLC v. Pharmacyclics LLC
`Case IPR2015-01076
`
`

`

`PTO/SB/30EFS (07-09)
`Doc code: RCEX
`Approved for use through 07/31/2012. OMB 0651-0031
`Doc description: Request for Continued Examination (ROE)
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`Signature of Registered U.S. Patent Practitioner
`
`Signature
`
`/Michael Hostetler/
`
`Name
`
`Michael J. Hostetler, Ph.D., Esq.
`
`Date (YYYY-MM-DD) 2014-01-30
`
`Registration Number
`
`47664
`
`This collection of information is required by 37 CFR 1.114. 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. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.11 and 1.14. This collection is
`estimated to take 12 minutes 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 time you require to complete this form and/or suggestions for
`reducing this burden, should be sent to the Chief Information Officer, U.S. Patent and Trademark Office, U.S. Department of Commerce,
`P.O. Box 1450, Alexandria, VA 22313-1450.
`If you need assistance in completing the form, call 1-800-PTO-9199 and select option 2.
`
`EFS - Web 2.1.15
`
`Exhibit 2015 Page 002
`
`

`

`Privacy Act Statement
`
`The Privacy Act of 1974 (P.L. 93-579) requires that you be given certain information in connection with your submission of the
`attached form related to a patent application or patent. Accordingly, pursuant to the requirements of the Act, please be
`advised that: (1) the general authority for the collection of this information is 35 U.S.C. 2(b)(2); (2) furnishing of the information
`solicited is voluntary; and (3) the principal purpose for which the information is used by the U.S. Patent and Trademark Office
`is to process and/or examine your submission related to a patent application or patent. If you do not furnish the requested
`information, the U.S. Patent and Trademark Office may not be able to process and/or examine your submission, which may
`result in termination of proceedings or abandonment of the application or expiration of the patent.
`
`The information provided by you in this form will be subject to the following routine uses:
`
`1. The information on this form will be treated confidentially to the extent allowed under the Freedom of Information Act
`(5 U.S.C. 552) and the Privacy Act (5 U.S.C. 552a). Records from this system of records may be disclosed to the
`Department of Justice to determine whether the Freedom of Information Act requires disclosure of these records.
`
`2. A record from this system of records may be disclosed, as a routine use, in the course of presenting evidence to a
`court, magistrate, or administrative tribunal, including disclosures to opposing counsel in the course of settlement
`negotiations.
`
`3. A record in this system of records may be disclosed, as a routine use, to a Member of Congress submitting a request
`involving an individual, to whom the record pertains, when the individual has requested assistance from the Member
`with respect to the subject matter of the record.
`
`4. A record in this system of records may be disclosed, as a routine use, to a contractor of the Agency having need for
`the information in order to perform a contract. Recipients of information shall be required to comply with the
`requirements of the Privacy Act of 1974, as amended, pursuant to 5 U.S.C. 552a(m).
`
`5. A record related to an International Application filed under the Patent Cooperation Treaty in this system of records may
`be disclosed, as a routine use, to the International Bureau of the World Intellectual Property Organization, pursuant to
`the Patent Cooperation Treaty.
`
`6. A record in this system of records may be disclosed, as a routine use, to another federal agency for purposes of
`National Security review (35 U.S.C. 181) and for review pursuant to the Atomic Energy Act (42 U.S.C. 218(c)).
`
`7. A record from this system of records may be disclosed, as a routine use, to the Administrator, General Services, or
`his/her designee, during an inspection of records conducted by GSA as part of that agency's responsibility to
`recommend improvements in records management practices and programs, under authority of 44 U.S.C. 2904 and
`2906. Such disclosure shall be made in accordance with the GSA regulations governing inspection of records for this
`purpose, and any other relevant (i.e., GSA or Commerce) directive. Such disclosure shall not be used to make
`determinations about individuals.
`8. A record from this system of records may be disclosed, as a routine use, to the public after either publication of the
`application pursuant to 35 U.S.C. 122(b) or issuance of a patent pursuant to 35 U.S.C. 151. Further, a record may be
`disclosed, subject to the limitations of 37 CFR 1.14, as a routine use, to the public if the record was filed in an
`application which became abandoned or in which the proceedings were terminated and which application is
`referenced by either a published application, an application open to public inspections or an issued patent.
`
`9. A record from this system of records may be disclosed, as a routine use, to a Federal, State, or local law enforcement
`agency, if the USPTO becomes aware of a violation or potential violation of law or regulation.
`
`EFS - Web 2.1.15
`
`Exhibit 2015 Page 003
`
`

`

`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Attorney Docket No. 25922-819.301
`PATENT
`
`Inventor:
`
`Joseph J. BUGGY, et al.
`
`Group Art Unit:
`
`1627
`
`Serial Number:
`
`13/340,522
`
`Examiner:
`
`RAMACHANDRAN,
`Umamaheswari
`
`Filing Date:
`
`December 29, 2011
`
`CONFIRMATION NO:
`
`7251
`
`Title: USE OF INHIBITORS OF BRUTON'S
`TYROSINE KINASE (BTK)
`FILED ELECTRONICALLY ON: January 30, 2014
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria VA 22313-1450
`
`SUPPLEMENTAL INFORMATION DISCLOSURE STATEMENT
`UNDER 37 CFR §1.97
`
`Madam:
`
`An Information Disclosure Statement along with attached PTO/SB/08 is hereby submitted. A
`copy of each listed publication is submitted, if required, pursuant to 37 CFR §§1.97-1.98, as indicated
`
`below.
`
`The Examiner is requested to review the information provided and to make the information of
`record in the above-identified application. The Examiner is further requested to initial and return the
`
`attached PTO/SB/08 in accordance with MPEP §609.
`The right to establish the patentability of the claimed invention over any of the information
`provided herewith, and/or to prove that this information may not be prior art, and/or to prove that this
`information may not be enabling for the teachings purportedly offered, is hereby reserved.
`
`This statement is not intended to represent that a search has been made or that the information
`
`cited in the statement is, or is considered to be, prior art or material to patentability as defined in § 1.56.
`
`A. ® 37 CFR §1.97(b). This Information Disclosure Statement should be considered by the Office
`because:
`
`Q
`
`(1)
`
`Q
`
`(2)
`
`It is being filed within 3 months of the filing date of a national application and is
`other than a continued prosecution application under § 1.53(d);
`-- OR --
`It is being filed within 3 months of entry of the national stage as set forth in
`§ 1.491 in an international application;
`
`Exhibit 2015 Page 004
`
`

`

`U.S. Apppl. No. 13/340,522
`
`Attorney Docket No. 25922-819.301
`
`0
`
`(3)
`
`-- OR --
`It is being filed before the mailing of a first Office action on the merits;
`
`0
`
`(4)
`
`-- OR --
`It is being filed before the mailing of a first Office action after the filing of a
`request for continued examination under §1.114.
`B. Q 37 CFR §1.97(c). Although this Information Disclosure Statement is being filed after the period
`specified in 37 CFR §1.97(b), above, it is filed before the mailing date of the earlier of (1) a final
`office action under §1.113, (2) a notice of allowance under §1.311, or (3) an action that otherwise
`closes prosecution on the merits, this Information Disclosure Statement should be considered because
`it is accompanied by one of:
`
`Q
`
`I
`
`a statement as specified in § 1.97(e) provided concurrently herewith;
`-- OR --
`a fee of $180.00 as set forth in § 1.17(p) authorized below, enclosed, or included with the
`payment of other papers filed together with this statement.
`C. Q 37 CFR §1.97(d). Although this Information Disclosure Statement is being filed after the mailing
`date of the earlier of (1) a final office action under §1.113 or (2) a notice of allowance under §1.311,
`it is being filed before payment of the issue fee and should be considered because it is accompanied
`by:
`
`i. a statement as specified in §1.97(e);
`
`ii.
`
`C
`
`L
`
`-- AND --
`a fee of $180.00 as set forth in §1.17(p) is authorized below, enclosed, or included
`with the payment of other papers filed together with this Statement.
`D. Q 37 CFR fl.97(e). Statement.
`A statement is provided herewith to satisfy the requirement under 37 CFR §§1.97(c);
`Q
`-- AND/OR --
`A statement is provided herewith to satisfy the requirement under 37 CFR §§ 1.97(d);
`-- AND/OR --
`A copy of a dated communication from a foreign patent office clearly showing that the
`information disclosure statement is being submitted within 3 months of the filing date on
`the communication is provided in lieu of a statement under 37 C.F.R. § 1.97(e)(1) as
`provided for under MPEP 609.04(b) V.
`E. Q Statement Under 37 C.F.R. §1.704(d). Each item of information contained in the information
`disclosure statement was first cited in a communication from a foreign patent office in a counterpart
`application that was received by an individual designated in § 1.56(c) not more than thirty (30) days
`prior to the filing of this information disclosure statement. This statement is made pursuant to the
`requirements of 37 C.F.R. § 1.704(d) to avoid reduction of the period of adjustment of the patent term
`for Applicant(s) delay.
`F. ® 37 CFR §1.98()(2). The content of the Information Disclosure Statement is as follows:
`O
`Copies of each of the references listed on the attached Form PTO/SB/08 are enclosed
`herewith.
`
`Exhibit 2015 Page 005
`
`

`

`U.S. Appl. No. 13/'340,522
`
`Attorney Docket No. 25922-819.301
`
`-- OR --
`
`®
`
`®
`
`Copies of U.S. Patent Documents (issued patents and patent publications) listed on the
`attached Form PTO/SB/08 are NOT enclosed.
`
`-- AND/OR --
`
`Copies of Foreign Patent Documents and/or Non Patent Literature Documents listed on
`the attached Form PTO/SB/08 are enclosed in accordance with 37 CFR §1.98 (a)(2).
`
`-- AND/OR --
`
`®
`
`Copies of pending unpublished U.S. patent applications are enclosed in accordance with
`37 CFR § 1.98(a)(2)(iii).
`G. Q 37 CFR §1.98(a)(3). The Information Disclosure Statement includes non-English patents and/or
`references.
`O
`
`Pursuant to 37 CFR § 1.98(a)(3)(i), a concise explanation of the relevance of each patent,
`publication or other information provided that is not in English is provided herewith.
`Pursuant to MPEP 609(B), an English language copy of a foreign search report is
`submitted herewith to satisfy the requirement for a concise explanation where
`non-English language information is cited in the search report.
`
`Q
`
`-- OR --
`
`O
`
`A concise explanation of the relevance of each patent, publication or other
`information provided that is not in English is as follows:
`
`Q
`
`Pursuant to 37 CFR §1.98(a)(3)(ii), a copy of a translation, or a portion thereof, of the
`non-English language reference(s) is provided herewith.
`H. ® 37 CFR ,1.98(d). Copies of patents, publications and pending U.S. patent applications, or other
`information specified in 37 C.F.R. § 1.98(a) are not provided herewith because:
`Pursuant to 37 CFR §1.98(d)(1) Cite Nos. 1-9, 11-17 and 28-76 were previously
`submitted in an Information Disclosure Statement, or cited by examiner, for another
`application under which this application claims priority for an earlier effective filing date
`under 35 U.S.C. 120.
`
`®
`
`Application in which the information was submitted:
`
`13/153,317
`
`Information Disclosure Statement(s) filed on:
`
`12/9/2013
`
`®
`
`AND
`The information disclosure statement submitted in the earlier application complied with
`paragraphs (a) through (c) of 37 CFR §1.98.
`
`Exhibit 2015 Page 006
`
`

`

`U.S. Appl. No. 13/340,522
`
`Attorney Docket No. 25922-819.301
`
`I. ® Fee Authorization. The Commissioner is hereby authorized to charge the above-referenced fees
`of $0.00 and charge any additional fees or credit any overpayment associated with
`this
`communication to Deposit Account No. 23-2415 (Docket No. 25922-819.301).
`
`Respectfully submitted,
`
`WILSON SONSINI GOODRICH & ROSATI
`
`By: /Michael Hostetler/
`Michael J. Hostetler
`Registration No. 47,664
`
`Dated:
`
`January 30, 2014
`
`650 Page Mill Road
`Palo Alto, CA 94304-1050
`(650) 493-9300
`Customer No. 021971
`
`Exhibit 2015 Page 007
`
`

`

`PTO/SBt/08a (07-09)
`Approved for use through 07/31/2012. OMB 0651-0031
`U.S. Patent and Trademark Office: U.S. DEPARITIENT OF COMMERCE
`Under the Papenrwork Reduction Act of 1995, no persons required to respond to a collection of information unless it conlains 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 necessar)
`
`Application Number
`Filing Date
`First Named Inventor
`Art Unit
`Examiner Name
`
`Sheet
`
`1
`
`of
`
`10
`
`Attorney Docket Number
`
`Examiner
`Initials*
`
`Cite
`1
`No.
`
`1.
`2.
`
`Examiner
`Initials*
`
`Cite
`No.'
`
`3.
`4.
`5.
`6.
`7.
`8.
`9.
`10.
`
`U.S. PATENT DOCUMENTS
`Name of Patentee or
`Publication Date
`Applicant of Cited Document
`MM-DD-YYYY
`
`Document Number
`Number-Kind Code (ifknotvr)
`US-2010-0016296
`US-2010-0185419
`
`1/21/2010
`7/22/2010
`
`Singh et al.
`Singh et al.
`
`U.S. UNPUBLISHED PATENT DOCUMENTS
`Name of Applicant of Cited
`Filing Date
`Document
`MM-DD-YYYY
`
`Document Number
`Number-Kind Code (if known)
`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
`
`Honigberg et al.
`9/20/2013
`10/31/2013 Honigberg et al.
`Honigberg et al.
`11/6/2013
`Honigberg et al.
`11/6/2013
`11/14/2013 Honigberg et al.
`11/14/2013 Honigberg et al.
`11/14/2013 Honigberg ct al.
`Honigherg et al.
`1/10/2014
`
`Pages, Columns, Lines, Where
`Relevant Passages or Relevant
`Figures Appear
`
`Pages, Colums, Lines, Where
`Relevant Passages or Relevant
`Figures Appear
`
`Examiner
`Initials*
`
`Cite
`No.'
`
`Foreign Patent Document
`
`FOREIGN PATENT DOCUMENTS
`Name of Patentee or
`Publication Date
`Applicant of Cited Document
`MM-DD-YYYY
`
`Coitury Code -Numlbel - KudCode (ifk o unr
`
`Pages, Columns, tines,
`Where Relevant Passages
`Or Relevant Figures Appear
`
`T
`
`Date
`Examiner
`Considered
`Signature
`m i conformance wtth MEit P 609 Draw line throiugh citanoni
`cornJrmarnce and not considered Iclude copy
`*EYAAIINER: Inital / reference coidered whether or not cit atti
`'Applicant's umnqu cltathon designation number (optional). 2See KInds Codes of ISPTO Patent Documents at s Yrt t. ggtav or MP.P
`ofthis form with next communication to apphcanr
`901.04. 'Enter Office that issued the document, by the two-letter code (WIPO Standard ST.3). 'For Japanese patent documents, the Indication of the 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 rnder WIPO Standard ST.16 f possible. 'Apphicant 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
`apphcation. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.14. This collection is estimated to take 2 hours to complete. ncluding gathering, preparing, and subnmitting the
`completed application form to the USPTO. Tune will varn depending upon the individual case. Any coinwents on the amount of tune you require to complete tlus form andor suggestions for
`reducing iths burden, should be sent to ie Chief
`Inti luton Olicei, U.S. Palenl and Trademarlk Office, P.O. Box 1450, Alexrandia, VA 22313-1450. DO NOT SEND FEES OR COMPLETED
`C
`FORMlS TO TIllS ADDRESS. SEND TO: Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`romplrng the fl r all /-R00-PT(-9199 (l-800-786-9/99) aad selerr optlon 2
`JIf a need rass rrarm\
`
`ij
`
`Exhibit 2015 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
`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
`Umamaheswari
`RAMANCHANDRAN
`25922-819.301
`
`Substitute for form 1449/PTO
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`(Use as many sheets as recessart)
`
`Application Number
`Filing Date
`First Named Inventor
`Art Unit
`Examiner Name
`
`Sheet
`
`2
`
`of
`
`10
`
`Attorney Docket Number
`
`Examiner
`Initials*
`
`Cite
`No.'
`11.
`
`12.
`
`13.
`
`14.
`
`15.
`
`16.
`
`17.
`
`18.
`
`19.
`
`20.
`21.
`
`22.
`
`23.
`
`24.
`
`25.
`
`26.
`
`27.
`
`28.
`
`29.
`
`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. jourial. 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
`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 Developmenl Timeline for PCI-
`45292", March 2, 2011
`WITZIG et al. "Detection of myeloma cells in the peripheral blood by flow cytometry."
`Cylometry (Conmmunications in Clinical Cytometry), 26:113-120 (1996)
`LICHTMAN "Battling 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
`CIHANG et al. "Ig-ress of CD 19CD5+ cells into peripheral blood following treatment
`with the Bruton lyrosine 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
`
`Date
`Examiner
`Considered
`Si ature
`iLO'EI' 609 Draw ine through cnat on j not i, conf manr:ce ad not consireoed
`inctude cop,
`i tiral iJ reerence con cdered, h,theil
`conr marre with
`*EX,AMINER:
`or
`.i ,',0 or MPEP
`ci clallon designation nmnher (optional). -See Kinds Codes of UISPTO Patent Documents at wry
`to appihcant. Appliclnt. s rIliq
`of this form with next comrllunintln
`'For Japanese patent documents. tile indication of the year of the leign of the Emperor intst
`901.04. 'Enter Office that issued the document. by the two-lettel code (WIPO Standard ST.3)
`precede the serial number of the patent document. Kind of document by the appiopate symbol s as indicated on the document tnder WIPO Standard ST.16 if possible. App]licant is to place a
`check mark here ifEnghsh language Translation is attached.
`This collection of information is required by 37 CFR I 97 and 1.98. The information is required to obtain or retaln a benefit by the public which is to file (and by the USPTO to process) an
`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
`application. Confidentiality
`completed application form to the USPTO. Tune will vary depending upon the individual case. Any connments on tile amount of tmne you require to complete this form and/or suggestions for
`ledumcag
`tis burden, should be sent to the Cluef Intforimaron Oflicer, U.S. Patent and Trademark Office, P.O. Box 1450, Alexarnd ia, VA 22313-1450. DO NOT SEND FEES OR COlMPLETED
`IFORMS TO 1iltS ADDRESS. SEND 'rO: Commnissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`if ornu need aristmace i, completing the jorm, call 1-800-PTO-9199 (1-800-786-9199) and select opion 2
`
`Exhibit 2015 Page 009
`
`

`

`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 infomation 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 recessar7Ar
`
`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.
`
`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.
`of Oral PCI-32765 and the effect of grapefiruit 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/!ct2show/study/NCT0 1866033 NLM Identifier: NCT01866033.
`Janssen Research and Development, 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- [cited 2013 Nov 22]. Available from:
`http://clinicaltrials.gov/ct2/show/NCT01674322 NLM Identifier: NCT01674322.
`Ohio State University Comprehensive 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/NCTO1589302 NLM Identifier:
`NCT01589302.
`Janssen Research and Development, LLC. A study of PCI-32765 (Ibrutinib) in patients
`with refiactory 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/ct2/show/NCT01779791 NLM Identifier: NCT01779791.
`National Cancer Institute (NCI). Rituximab and bendamustine hydrochloride, rituximab
`and ibrutinib, or ihbrutinib alone in treating older patients with previously untreated
`chronic lynmphocylic leukemia. In: ClinicalTrials.gov [Internet]. Bethesda (MD):
`National Library o' Medicine (US). 2013 Jun 24- [cited 2013 Nov 22]. Available from:
`http://clinicaltrials.gov/ct2ishowNCTO1886872 NLM Identifier: NCT01886872.
`Janssen Research and Development, LLC. A long-term extension study of PCI-32765
`(Ihrutinib). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of
`Medicine (US). 2013 Mar 04- [cited 2013 Nov 22]. Available from:
`http://clinicaltrials.gov/ct2ishow/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://climicaltrials.gov/ct2/show/NCT01626651 NLM
`
`Date
`Examiner
`Considered
`Signature
`, c o,ro normnce
`e throgh critation / not i, con/otr ace and not constdetred iclude copy
`*EXAMINVER: htnnal rJ reJerence co sdered whethr ot ,i cao,
`l''
`609 LDraw
`with
`of this form with next communication to applcant. Apphcnl'ts Iniqlc clt ilton designation number (oplional). See Kindt Codes of IJSPTO Patent Documents at wvw_ .i
`, Lg o Ml'EP
`901.04. 'Enter Office that issued the document, by the two-letter code (WPO StandardST.3).
`'For Japanese patent documents, the indication of the year of te reign of the Empetor rmust
`precede the serial number of the patent docrument. 'Kind of document by tile appIoprate symbols as indicated on the document under WIPO Standard ST.16 if possible. Applicant is to place a
`check mark here ifEnglish language Translation is attached.
`This collection of rnfonmation 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
`apphcation. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR .14. rhis collection is esurnated to take 2 hours to complete, including gatherlng, preparing, and submitting the
`completed application form to the USPTO. Tme will vary dependrng upon the ndividual case. Any comments on the amount of time you require to complete this form and/or suggestions for
`reducming is burden, shotuld be sent to the Chief tnlorinaton Oflicr, U.S. Patent and Trade ark Office, P.O. Box 1450, Alexandla, VA 22313-1450. DO NOT SEND FEES OR COMPLETED
`FORMS 'IO TIllS ADI)EISS. SEND TO: Commnissioner for Patents, P.O. Iox 1450, Alexandria, VA 22313-1450.
`ig
`the form, call 1-800-PO-91/99 (l-800-786-9199) and select optln: 2
`Ifyou need ai.-staince t comnler
`
`Exhibit 2015 Page 010
`
`

`

`PT O/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 Papenvork Reduction Act of 1995, no persons required to respond to a collection of infonmation 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
`
`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 mumber(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 subltype of di llse large B-cell lymphoma. In: ClinicalTrials.gov
`[Internel]. Bethesda (MD): National Library of Medicine (US). 2013 May 14- [cited
`2013 Nov 22]. Available lrom: http://!iclinicaltrials.gov/ct2/show/NCT01855750 NLM
`Identificr: NCT)1855750.
`Janssen Research and Development, LLC. A pharmacokinetic study in healthy
`participants to assess the pharmacokinctics and safety of a supratherapcutic dose of
`PCI-32765 (lbrulinib) capsule and solution formulations administered with food. In:
`ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2013
`Aug 19- [cited 2013 Nov 22]. Available from:
`http://clinicarllials.gov/ct2ishow/NCT01969266 NLM Identifier: NCT01969266.
`National Center Institute (NCI). Lenalidomide and Ibrutinib in treating patients with
`relapsed or reflactory chronic lymphocytic leukemia or small lymphocytic lymphoma.
`In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US).
`2013 Jun 24- [cited 2013 Nov 22]. Available from:
`http://clinicaltrials.gov/ct2ishow/NCT01886859 NLM Identifier: NCT01886859.
`Janssen Research and Development, LLC. A study to determine the effect of food on
`the pharmacokinetics of PCI-32765. In: ClinicalTrials.gov [Internet]. Bethesda (MD):
`National Library of Medicine (US). 2013 Mar 04- [cited 2013 Nov 22]. Available from:
`http://clinicaltrials.gov/ct2ishow/NCT01820936 NLM Identifier: NCT01820936.
`Janssen Research and Development, LLC. A study combining Ibrutinib with rituximab,
`cyclophosphamide, doxorubicin, vincristine, and prednisone in patients with CD20-
`positive B-cell non Hodgkin 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/NCT01569750 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
`
`Date
`Examiner
`Considered
`Signature
`*EYAMINER: Initial f reJerence consder ed, w hether or not citaon is
`u conJormance with MPU'E 609. Draw hne through citation i not in conjonance an;d not considered include copy
`ofthis form with next commlncaton to applicant. Apphlcanl's Ilnlque citation designation number (optional). SCee Kinds Codes of USPTO Patent Documents at wyo _ity,
`or MPEP
`For Japanese patent documents. the indicatio