Receipt date: 09/19/2011
`
`12966261 - GAU: 3686
`
`Substitute for 1449/PTO
`
`Complete if Known
`12/966,261
`Application Number
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`Filing Date
`
`December 13, 2010
`
`First Named Inventor
`
`Williams et al.
`
`Sheet
`
`(use as many sheets as necessary)
`I
`I
`I
`
`of
`
`1
`
`Art Unit
`
`Examiner Name
`
`3769
`
`Kai Rajan
`
`6
`
`Attorney Docket Number CELG-0642
`
`Examiner
`Initials
`
`Cite
`No.
`
`U. 5. PUBLICATION AND PATENT DOCUMENTS
`Publication or
`Document Number
`Grant Date
`MM-DD-YYYY
`
`Number- Kind Code (if known)
`
`Name of Patentee or Applicant of Cited Document
`
`2005/0090425
`
`2005/0216309
`
`2005/02228 7 4
`
`2006/0129433
`
`5,299,121
`
`5,594,637
`
`5,619,991
`
`5,660,176
`
`5,758,095
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`04-28-2005
`
`Reardan et al.
`
`09-29-2005
`
`Reardan et al.
`
`10-06-2005
`
`Reardan et al.
`
`06-15-2006
`
`Koneru
`
`03-20-1994
`
`Brill et al.
`
`01-14-1997
`
`Eisenberg et al.
`
`04-15-1997
`
`Sloane
`
`08-26-1997
`
`Iliff
`
`05-26-1998
`
`Albaum et al.
`
`Cunningham
`
`5,832,449
`
`5,845,255
`
`5,974,203
`
`6,014,631
`
`6,045,501
`
`6,055,507
`
`6,063,026
`
`6,128,620
`
`6,131,090
`
`6,202,923
`
`6,315,720
`
`6,561,976
`
`6,561,977
`
`6,755,784
`
`6,767,326
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`11-03-1998
`
`12-01-1998
`
`Mayaud
`
`10-26-1999
`
`Tadokoro et al.
`
`01-11-2000
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`Teagarden et al.
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`04-04-2000
`
`Elsayed et al.
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`04-25-2000
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`Cunningham
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`Schauss et al.
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`10-03-2000
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`Pissanos et al.
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`10-10-2000
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`Williams et al.
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`05-13-2003
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`Elsayed et al.
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`Williams et al.
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`06-29-2004
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`Williams et al.
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`07-27-2004
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`/Jor1r1 Pauis/ (06/29/2012)
`
`06/29/2012
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH. /J.P./
`
`CFAD VI 1075 - 0001
`CFAD VI v. CELGENE
`IPR2015-01102
`
`

`
`Receipt date: 09/19/2011
`
`12966261 - GAU: 3686
`
`Substitute for 1449/PTO
`
`Complete if Known
`12/966,261
`Application Number
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`Filing Date
`
`December 13, 2010
`
`First Named Inventor
`
`Williams et al.
`
`(use as many sheets as necessary)
`
`Examiner Name
`
`Art Unit
`
`3769
`
`Kai Rajan
`
`Sheet
`
`I
`
`2
`
`I
`
`of
`
`I
`
`6
`
`Attorney Docket Number CELG-0642
`
`Examiner
`Initials
`
`Cite
`No.
`
`U.S. PUBLICATION AND PATENT DOCUMENTS
`Publication or
`Document Number
`Grant Date
`MM-DD-YYYY
`
`Number- Kind Code (if known)
`
`Name of Patentee or Applicant of Cited Document
`
`25
`26
`27
`28
`
`6,869,399
`
`6,908,432
`
`7,141,018
`
`7,959,566
`
`03-22-2005
`
`Williams et al.
`
`06-21-2005
`
`Elsayed et al.
`
`11-28-2006
`
`Williams et al.
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`06-14-2011
`
`Williams et al.
`
`FOREIGN PATENT DOCUMENTS
`
`Examiner
`Initials
`
`Cite
`No.
`
`29
`
`30
`31
`32
`33
`34
`
`Foreign Patent Document
`Country Code- Number -Kind Code
`(if known)
`CA 2352619
`wo 00/51053
`wo 02/35440
`wo 98/13783
`wo 98/58338
`wo 99/10829
`
`Publication Date
`MM-DD-YYYY
`
`Name of Patentee or Applicant of Cited Document
`
`T
`
`01-06-2003
`
`Rajewski, Robert
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`08-31-2000
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`Gemini Research Ltd.
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`Celgene Corp.
`
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`Azron Inc.
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`Promedicus Systems Inc.
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`
`Examiner
`Initials
`
`Cite
`No.
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`Include name of the author, 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.
`
`T
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`35
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`36
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`38
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`06/29/2012
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH. /J.P./
`
`CFAD VI 1075 - 0002
`
`

`
`Receipt date: 09/19/2011
`
`12966261 - GAU: 3686
`
`Substitute for 1449/PTO
`
`Complete if Known
`12/966,261
`Application Number
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`Filing Date
`
`December 13, 2010
`
`First Named Inventor
`
`Williams et al.
`
`(use as many sheets as necessary)
`
`Examiner Name
`
`Art Unit
`
`3769
`
`Kai Rajan
`
`Sheet
`
`I
`
`3
`
`I
`
`of
`
`I
`
`6
`
`Attorney Docket Number CELG-0642
`
`NON PATENT LITERATURE DOCUMENTS
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`Bates et al., "Effect of Computerized Physician order Entry and a Intervention on Prevention
`of Serious Medication Errors", The Journal of the American Medical Association, October
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`
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`
`47
`
`48
`
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`
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`
`51
`
`/John Pauls/ (06/29/2012)
`
`06/29/2012
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH. /J.P./
`
`CFAD VI 1075 - 0003
`
`

`
`Receipt date: 09/19/2011
`
`12966261 - GAU: 3686
`
`Substitute for 1449/PTO
`
`Complete if Known
`12/966,261
`Application Number
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`Filing Date
`
`December 13, 2010
`
`First Named Inventor
`
`Williams et al.
`
`(use as many sheets as necessary)
`
`Examiner Name
`
`Art Unit
`
`3769
`
`Kai Rajan
`
`Sheet
`
`I
`
`4
`
`I
`
`of
`
`I
`
`6
`
`Attorney Docket Number CELG-0642
`
`52
`
`53
`
`54
`
`55
`
`56
`
`57
`
`58
`
`59
`
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`Commercial Sponsors", The Pink Sheet, November 18, 1996, 58(047), page T&G-4
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`Fax to ian Hilley of GenPharm Inc. to John Jackson of Celgene Corp., October 14, 2004, re:
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`related to Agranulocytosis", Psychiatric Services, January 1996, 47(1), 52-56
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`Honigfeld, "Reducing clozapine-related morbidity and mortality: 5 years of experience with
`the clozaril national registry," J. Clin. Psychiatry, 1998, 59(Suppl. 3), 3-7
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`Janet Woodcock, "Supervisory Review of NDA 20-785", Center for Drug Evaluation and
`Research, July 07, 1998, 12 pages
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`Kumar "Ciozaril monitoring systems, registry data and analyses," Presentation, Novartis,
`2002, 44 pages
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`Lieberman et al., "A report of clozapine- induced agranulocytosis in the United States
`(Incidence and risk factors)," Drug Safety, Proceedings of a symposium held in London,
`1991, Hoffbrand, A.V, et al. (Eds.), 1-2
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`Hasp. Pharm., 1993, 1657-1662
`Martin, "APhA says plan continues to interfere with pharmacists' practice prerogatives," Am.
`Pharmacy, 1991, NS31(5), 30-31
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`McCullough, "Roche Announces FDA Approval of Enhanced Pregnancy Prevention
`Program for Accutane", Current News Releases, October 31, 2001, 1 page
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`Mitchell et al., "A Pregnancy-Prevention Program in Women of Childbearing Age Receiving
`lsotretinoin", New England Journal of Medicine, July 13, 1995, 333(2), 101-106
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`Mordue, "Rational approach to clozaril distribution," Am. Pharmacy, 1990, NS30(6), page 7
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`/Jol1n Pauls/ (06i29/2012)
`
`06/29/2012
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH. /J.P./
`
`CFAD VI 1075 - 0004
`
`

`
`Receipt date: 09/19/2011
`
`12966261 - GAU: 3686
`
`Substitute for 1449/PTO
`
`Complete if Known
`Application Number
`12/966,261
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`Filing Date
`
`December 13, 2010
`
`First Named Inventor
`
`Williams et al.
`
`(use as many sheets as necessary)
`
`Examiner Name
`
`Art Unit
`
`3769
`
`Kai Rajan
`
`Sheet
`
`I
`
`5
`
`I
`
`of
`
`I
`
`6
`
`Attorney Docket Number CELG-0642
`
`NON PATENT LITERATURE DOCUMENTS
`
`National Institutes of Health et al, ''Thalidomide: Potential Benefits and Risks", Open Public
`Scientific Workshop, NIH Testimony, http://WW\iV.fda.govioashi/patrep/nih99.html,
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`National Institutes of Health et al, "Thalidomide: Potential Benefits and Risks", Open Public
`Scientific Workshop, NIH Testimony, http://wvvw.fda.gov/oashi/patrep/nih91 O.html,
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`National Institutes of Health et al., "Thalidomide: Potential Benefits and Risks:", Open Public
`Scientific Workshop, Program and Abstracts, September 09-10, 1997
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`Re: Notification Pursuant to section 505U)(2)(B)(ii) of the Federal Food, Drug and Cosmetic
`Act
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`Notification Letter dated December 15, 2006 from Sterne Kessler to Celgene Corporation
`Re: Supplemental Notification Pursuant to section 505(j)(2)(B)(ii) of the Federal Food, Drug
`and Cosmetic Act
`
`Notification Letter dated December 19, 2006 from Sterne Kessler to Celgene Corporation
`Re: Supplemental Notification Pursuant to section 505(j)(2)(B)(ii) of the Federal Food, Drug
`and Cosmetic Act
`
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`Re: Supplemental Notification Pursuant to section 505(j)(2)(B)(ii) of the Federal Food, Drug
`and Cosmetic Act
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`73
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`74
`
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`76
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`
`/John Pauls/ (06/29/2012)
`
`06/29/2012
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH. /J.P./
`
`CFAD VI 1075 - 0005
`
`

`
`Receipt date: 09/19/2011
`
`12966261 - GAU: 3686
`
`Substitute for 1449/PTO
`
`Complete if Known
`12/966,261
`Application Number
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`Filing Date
`
`December 13, 2010
`
`First Named Inventor
`
`Williams et al.
`
`(use as many sheets as necessary)
`
`Examiner Name
`
`Art Unit
`
`3769
`
`Kai Rajan
`
`Sheet
`
`I
`
`6
`
`I
`
`of
`
`I
`
`6
`
`Attorney Docket Number CELG-0642
`
`NON PATENT LITERATURE DOCUMENTS
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`
`06/29/2012
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH. /J.P./
`
`CFAD VI 1075 - 0006
`
`

`
`Substitute for 1449/PTO
`
`Complete if Known
`12/966,261
`Application Number
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`Filing Date
`
`December 13, 2010
`
`First Named Inventor
`
`Williams et al.
`
`(use as many sheets as necessary)
`
`Examiner Name
`
`Art Unit
`
`3769
`
`Kai Rajan
`
`Sheet
`
`I
`
`1
`
`I
`
`of
`
`I
`
`6
`
`Attorney Docket Number CELG-0642
`
`Examiner
`Initials
`
`Cite
`No.
`
`U. 5. PUBLICATION AND PATENT DOCUMENTS
`Publication or
`Document Number
`Grant Date
`MM-DD-YYYY
`
`Number- Kind Code (if known)
`
`Name of Patentee or Applicant of Cited Document
`
`2005/0090425
`
`2005/0216309
`
`2005/02228 7 4
`
`2006/0129433
`
`5,299,121
`
`5,594,637
`
`5,619,991
`
`5,660,176
`
`5,758,095
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`04-28-2005
`
`Reardan et al.
`
`09-29-2005
`
`Reardan et al.
`
`10-06-2005
`
`Reardan et al.
`
`06-15-2006
`
`Koneru
`
`03-20-1994
`
`Brill et al.
`
`01-14-1997
`
`Eisenberg et al.
`
`04-15-1997
`
`Sloane
`
`08-26-1997
`
`Iliff
`
`05-26-1998
`
`Albaum et al.
`
`5,832,449
`
`5,845,255
`
`5,974,203
`
`6,014,631
`
`6,045,501
`
`6,055,507
`
`6,063,026
`
`6,128,620
`
`6,131,090
`
`6,202,923
`
`6,315,720
`
`6,561,976
`
`6,561,977
`
`6,755,784
`
`6,767,326
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`11-03-1998
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`Cunningham
`
`12-01-1998
`
`Mayaud
`
`10-26-1999
`
`Tadokoro et al.
`
`01-11-2000
`
`Teagarden et al.
`
`04-04-2000
`
`Elsayed et al.
`
`04-25-2000
`
`Cunningham
`
`05-16-2000
`
`Schauss et al.
`
`10-03-2000
`
`Pissanos et al.
`
`10-10-2000
`
`Basso Jr., et al.
`
`03-20-2001
`
`Bayer et al.
`
`11-13-2001
`
`Williams et al.
`
`05-13-2003
`
`Elsayed et al.
`
`05-13-2003
`
`Williams et al.
`
`06-29-2004
`
`Williams et al.
`
`07-27-2004
`
`Elsayed et al.
`
`I Examiner
`Stgnature
`
`I Date
`Constdered
`
`CFAD VI 1075 - 0007
`
`

`
`Substitute for 1449/PTO
`
`Complete if Known
`12/966,261
`Application Number
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`Filing Date
`
`December 13, 2010
`
`First Named Inventor
`
`Williams et al.
`
`(use as many sheets as necessary)
`
`Examiner Name
`
`Art Unit
`
`3769
`
`Kai Rajan
`
`Sheet
`
`I
`
`2
`
`I
`
`of
`
`I
`
`6
`
`Attorney Docket Number CELG-0642
`
`Examiner
`Initials
`
`Cite
`No.
`
`U.S. PUBLICATION AND PATENT DOCUMENTS
`Publication or
`Document Number
`Grant Date
`MM-DD-YYYY
`
`Number- Kind Code (if known)
`
`Name of Patentee or Applicant of Cited Document
`
`25
`26
`27
`28
`
`6,869,399
`
`6,908,432
`
`7,141,018
`
`7,959,566
`
`03-22-2005
`
`Williams et al.
`
`06-21-2005
`
`Elsayed et al.
`
`11-28-2006
`
`Williams et al.
`
`06-14-2011
`
`Williams et al.
`
`FOREIGN PATENT DOCUMENTS
`
`Examiner
`Initials
`
`Cite
`No.
`
`29
`
`30
`31
`32
`33
`34
`
`Foreign Patent Document
`Country Code- Number -Kind Code
`(if known)
`CA 2352619
`wo 00/51053
`wo 02/35440
`wo 98/13783
`wo 98/58338
`wo 99/10829
`
`Publication Date
`MM-DD-YYYY
`
`Name of Patentee or Applicant of Cited Document
`
`T
`
`01-06-2003
`
`Rajewski, Robert
`
`08-31-2000
`
`Gemini Research Ltd.
`
`05-02-2002
`
`Celgene Corp.
`
`04-02-1998
`
`Azron Inc.
`
`12-23-1998
`
`Promedicus Systems Inc.
`
`03-04-1999
`
`Lernout & Hauspie Speechprod
`
`NON PATENT LITERATURE DOCUMENTS
`
`Examiner
`Initials
`
`Cite
`No.
`
`Include name of the author, 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.
`
`T
`
`35
`
`36
`
`37
`
`38
`
`"About the CNR", httQs://WW\iV.clozarilcare.com/care/newUsrRegPersonal.isQ, 1 page
`
`"Complaint", In the United States District Court District of New Jersey, Case No.: 2:07-cv-
`00286-PGS-RJ H, Filed January 18, 2007, 16 pages
`
`"Defendant Barr Laboratories Inc.'s Answer, Counterclaims and Demand for Jury Trial", In
`the United States District Court District of New Jersey, Case No.: 2:07-cv-00286-PGS-RJH,
`filed March 01, 2007, 67 pages
`
`"Guide to the Clozaril Patient Monitoring Service", A Reference Manual for the Clozaril
`Patient Monitoring Service, First Edition, November 1997, 45 pages
`
`I Examiner
`Stgnature
`
`I Date
`Constdered
`
`CFAD VI 1075 - 0008
`
`

`
`Substitute for 1449/PTO
`
`Complete if Known
`12/966,261
`Application Number
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`Filing Date
`
`December 13, 2010
`
`First Named Inventor
`
`Williams et al.
`
`(use as many sheets as necessary)
`
`Examiner Name
`
`Art Unit
`
`3769
`
`Kai Rajan
`
`Sheet
`
`I
`
`3
`
`I
`
`of
`
`I
`
`6
`
`Attorney Docket Number CELG-0642
`
`NON PATENT LITERATURE DOCUMENTS
`
`"Managing a Product under Attack: A Firsthand report on Colzaril", Medical Marketing &
`Media, September 20, 1991, 26(10), 8 pages
`
`''Thalomid Information from Drugs.com", June 22, 2006, accessed February 01, 2008,
`httQ://wvvw.drugs.com/thalomid.html
`
`Bakken et al., "Local Monitoring Center for Clozapine Therapy: Quality Assurance of Drug
`Treatment in a Group of Psychiatric Patients", Tidsskr Nor Laegeforen nr., 1998, 118, 1076-
`1078
`
`Bastani et al., "Development of the Clozaril Patient Management System",
`Psychopharmacology, 1998, 99, S122-S125
`
`Bates et al., "Effect of Computerized Physician order Entry and a Intervention on Prevention
`of Serious Medication Errors", The Journal of the American Medical Association, October
`21, 1998, 280(15), 1289-1316
`
`Behm, No Title, Am. Pharmacy 131
`h APhA Annual Meeting Highlights, 1990, NS30(6), page
`7
`
`Bender, "FDA approves reduced clozapine monitoring; increased patient access versus
`increased risk," Psychiatric Times, 1998, Vol. XV, Issue 5, page 13
`
`Black et al., "A centralized system for monitoring clozapine use in British Columbia,"
`Psychiatric Services, 1996, 47(1), 81-83
`
`Bruera et al., "The uses of psychotropics in symptom management in advanced cancer,"
`Psycho-Oncology., 1998, 7, 346-358
`
`Celgene Corporation, "Thalomid (thalidomide): Balancing the Benefits and the Risks",
`System for Thalidomide Education and Prescribing Safety, November 1998, 52 pages
`
`Celgene Corporation, "Thalomid (thalidomide): Clinical Information and Prescribing
`Guidelines", Reference Guide, September 1998, 26 pages
`
`Center for Drug Evaluation and Research Food and Drug Administration, "Forty-Seventh
`Meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee", September 04-
`05, 1997, 447 pages
`
`Clark et al., "Thalidomide Capsules, A review of the first 18 months of spontaneous
`postmarketing adverse event surveillance, including off-label presrcribing," Drug Safety.,
`2001, 24(2), 87-117
`
`39
`
`40
`
`41
`
`42
`
`43
`
`44
`
`45
`
`46
`
`47
`
`48
`
`49
`
`50
`
`51
`
`I Examiner
`Stgnature
`
`I Date
`Constdered
`
`CFAD VI 1075 - 0009
`
`

`
`Substitute for 1449/PTO
`
`Complete if Known
`12/966,261
`Application Number
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`Filing Date
`
`December 13, 2010
`
`First Named Inventor
`
`Williams et al.
`
`(use as many sheets as necessary)
`
`Examiner Name
`
`Art Unit
`
`3769
`
`Kai Rajan
`
`Sheet
`
`I
`
`4
`
`I
`
`of
`
`I
`
`6
`
`Attorney Docket Number CELG-0642
`
`NON PATENT LITERATURE DOCUMENTS
`
`Dimopoulis et al. "Adverse effects of Thalidomide administration in patients with neoplastic
`diseases," Am. J. Med., October 1, 2004, 117,508-515
`
`Dunning, "Hoechst Arava Pregnancy Registry Recommended to Track Teratogenicity", The
`Pink Sheet, August 17, 1998, 60(033), 3 pages
`
`Dunning, ''Thalidomide Protocols and Patient Materials designed by FDA for Studies without
`Commercial Sponsors", The Pink Sheet, November 18, 1996, 58(047), page T&G-4
`
`Fax to ian Hilley of GenPharm Inc. to John Jackson of Celgene Corp., October 14, 2004, re:
`lsotretinoin Pregnancy Risk Management Program, 26 pages
`
`Freeman et al., "Will routine therapeutic drug monitoring have a place in clozapine
`therapy?," Clinical Pharmacokinetics, 1997, 32(2), 93-100
`
`Honigfeld, "Effects of the Clozapine National Registry System on Incidence of Deaths
`related to Agranulocytosis", Psychiatric Services, January 1996, 47(1), 52-56
`
`Honigfeld, "Reducing clozapine-related morbidity and mortality: 5 years of experience with
`the clozaril national registry," J. Clin. Psychiatry, 1998, 59(Suppl. 3), 3-7
`
`Janet Woodcock, "Supervisory Review of NDA 20-785", Center for Drug Evaluation and
`Research, July 07, 1998, 12 pages
`
`Kumar "Ciozaril monitoring systems, registry data and analyses," Presentation, Novartis,
`2002, 44 pages
`
`Lieberman et al., "A report of clozapine- induced agranulocytosis in the United States
`(Incidence and risk factors)," Drug Safety, Proceedings of a symposium held in London,
`1991, Hoffbrand, A.V, et al. (Eds.), 1-2
`Love et al., "Computerized relational database for monitoring clozapine therapy," Am. J.
`Hasp. Pharm., 1993, 1657-1662
`Martin, "APhA says plan continues to interfere with pharmacists' practice prerogatives," Am.
`Pharmacy, 1991, NS31(5), 30-31
`
`McCullough, "Roche Announces FDA Approval of Enhanced Pregnancy Prevention
`Program for Accutane", Current News Releases, October 31, 2001, 1 page
`
`Mitchell et al., "A Pregnancy-Prevention Program in Women of Childbearing Age Receiving
`lsotretinoin", New England Journal of Medicine, July 13, 1995, 333(2), 101-106
`
`Mordue, "Rational approach to clozaril distribution," Am. Pharmacy, 1990, NS30(6), page 7
`
`52
`
`53
`
`54
`
`55
`
`56
`
`57
`
`58
`
`59
`
`60
`
`61
`
`62
`
`63
`
`64
`
`65
`
`66
`
`I Examiner
`Stgnature
`
`I Date
`Constdered
`
`CFAD VI 1075 - 0010
`
`

`
`Substitute for 1449/PTO
`
`Complete if Known
`Application Number
`12/966,261
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`Filing Date
`
`December 13, 2010
`
`First Named Inventor
`
`Williams et al.
`
`(use as many sheets as necessary)
`
`Examiner Name
`
`Art Unit
`
`3769
`
`Kai Rajan
`
`Sheet
`
`I
`
`5
`
`I
`
`of
`
`I
`
`6
`
`Attorney Docket Number CELG-0642
`
`NON PATENT LITERATURE DOCUMENTS
`
`National Institutes of Health et al, ''Thalidomide: Potential Benefits and Risks", Open Public
`Scientific Workshop, NIH Testimony, http://WW\iV.fda.govioashi/patrep/nih99.html,
`September 09, 1997
`
`National Institutes of Health et al, "Thalidomide: Potential Benefits and Risks", Open Public
`Scientific Workshop, NIH Testimony, http://wvvw.fda.gov/oashi/patrep/nih91 O.html,
`September 10, 1997
`
`National Institutes of Health et al., "Thalidomide: Potential Benefits and Risks:", Open Public
`Scientific Workshop, Program and Abstracts, September 09-10, 1997
`
`Notification Letter dated December 05, 2006 from Sterne Kessler to Celgene Corporation
`Re: Notification Pursuant to section 505U)(2)(B)(ii) of the Federal Food, Drug and Cosmetic
`Act
`
`Notification Letter dated December 15, 2006 from Sterne Kessler to Celgene Corporation
`Re: Supplemental Notification Pursuant to section 505(j)(2)(B)(ii) of the Federal Food, Drug
`and Cosmetic Act
`
`Notification Letter dated December 19, 2006 from Sterne Kessler to Celgene Corporation
`Re: Supplemental Notification Pursuant to section 505(j)(2)(B)(ii) of the Federal Food, Drug
`and Cosmetic Act
`
`Notification Letter dated October 04, 2007 from Barr Laboratories to Cegene Corporation
`Re: Supplemental Notification Pursuant to section 505(j)(2)(B)(ii) of the Federal Food, Drug
`and Cosmetic Act
`
`Oyesanmi et al., "Hematologic side effects of psychotropics," Psychosomatics, 1999, 40,
`414-421
`
`Pastuszak et al, "Use of the Retinoid Pregnancy Prevention Program in Canada: Patterns of
`Contraception Use in Women treated with lsotretinoin and Etretinate", Reproductive
`Toxicology, 1994, 8( 1 ) , 63-68
`
`Patt et al., "Durable Clinical response of refractory hepatocellular to orally administered
`thalidomide," Am. J. Clin. Oneal. (CCT., 2000, 23(3), 319-321
`Peck et al., "FDA's position on the clozaril patient management system," Hospital &
`Community Psychiatry, 1990, 41 (8), 876-877
`Richardson et al., "Thalidomide: Emerging role in cancer medicine," Annu. Rev. Med., 2002,
`53, 629-657
`
`67
`
`68
`
`69
`
`70
`
`71
`
`72
`
`73
`
`74
`
`75
`
`76
`
`77
`
`78
`
`I Examiner
`Stgnature
`
`I Date
`Constdered
`
`CFAD VI 1075 - 0011
`
`

`
`Substitute for 1449/PTO
`
`Complete if Known
`12/966,261
`Application Number
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`Filing Date
`
`December 13, 2010
`
`First Named Inventor
`
`Williams et al.
`
`(use as many sheets as necessary)
`
`Examiner Name
`
`Art Unit
`
`3769
`
`Kai Rajan
`
`Sheet
`
`I
`
`6
`
`I
`
`of
`
`I
`
`6
`
`Attorney Docket Number CELG-0642
`
`NON PATENT LITERATURE DOCUMENTS
`Richardson et al., ''Thalidomide: The revival of a drug with Therapeutic promise in the
`treatment of cancer", In: Cancer: Principles and Practice of Oncology, 61
`h Ed., DeVita VT,
`Hellman S, Rosenberg SA, editors. Lippincott, Williams, and Wilkins, Philadelphia PA, 2001,
`1-18.
`
`Roche Pharmaceuticals et al., "lsotretinoin Makers Reach Agreement with Celgene on
`S.T.E.P.S.® Risk Management Patents", Press Release, November 23, 2004, 3 pages
`
`Roche Pharmaceuticals et al., "Product Information", Physician's Desk Reference, 1997,
`2252-2254 & 2377-2380
`
`Roche, "Pregnancy Prevention Program for Women on Accutane lsotretinoin. Accutane
`Therapy for Woman of Childbearing Potential", Physicians' and Healthcare Professionals'
`Guide, 1994, 15 pages
`
`Singhal et al. "Peer Viewpoint," J. Supportive Oncology, 1(3), September/October 2003,
`200-201
`
`Sittig et al., "Computer-based Physician Order Entry: The State of the Art", Journal of the
`American Medical Informatics Association, March/April August 29, 1994, 1(2), 108-123
`
`Somers, "Pharmacological Properties of Thalidomide (a-Phalidimido Glutarimide) a New
`Sedative-Hypnotic Drug," Brit. J. Pharmacal., 1960, 15, 111-116
`Teo et al., "Clinical pharmacokinetics of thalidomide," Clin Pharmacokinetics, April 2004,
`43(5), 311-327
`Thomas et al., "Thalidomide Nursing Roundtable Update," American Academy of CME, Inc.
`and OmegaMed Inc., publishers., September 2002
`
`Trussell, "Contraceptive Efficacy", Arch. Dermatol., September 1995, 131, 1064-1068
`
`Uhl et al., "Thalidomide Use in the US: Experience with Pregnancy Testing in the S.T.E.P.S.
`®Programme", Drug Safety, 2006, 29(4), 321-329
`
`Villahermosa et al., "A Randomized, Double-Blind, Double-Dummy, Controlled Dose
`Comparison of Thalidomide for Treatment of Erythema Nodosum Leprosum", Am. J. Trap.
`Med. Hyg., 2005, 72(5), 518-526
`
`Webster, "Preventing Birth Defects due to Thalidomide Exposure", Sheraton Colony Square
`Hotel, March 26, 1997, 27 pages
`
`Zeldis et al., "A Comprehensive Program for Controlling and Monitoring Access to
`Thalidomide", Frontiers in Fetal Health: A Global Perspective, August 1999, 1(2), 10-16
`
`79
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`80
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`81
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`82
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`83
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`84
`
`85
`
`86
`
`87
`
`88
`
`89
`
`90
`
`91
`
`92
`
`I Examiner
`Stgnature
`
`I Date
`Constdered
`
`CFAD VI 1075 - 0012