Receipt date: 1 0/12/2011
`
`12966240 - GAU: 3626
`
`Substitute for 1449/PTO
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`Complete if Known
`12/966,240
`Application Number
`
`Filing Date
`
`December 13, 2010
`
`First Named Inventor
`
`Marc Elsayed
`
`Art Unit
`
`3626
`
`Examiner Name
`
`Christopher L. Gilligan
`
`Sheet
`
`(use as many sheets as necessary)
`I
`I
`I
`
`of
`
`1
`
`7
`
`Attorney Docket Number CELG-0641
`
`U.S. PATENT APPLICATION DOCUMENTS
`
`Examiner
`Initials
`
`Cite
`No.
`
`Application Number
`
`Fling Date
`MM-DD-YYYY
`
`Name of Patentee or Applicant of Cited Document
`
`1
`
`09/479,682
`
`01-07-2000
`
`Elsayed
`
`Examiner
`Initials
`
`Cite
`No.
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`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
`
`2006/0129433
`
`06-15-2006
`
`Koneru
`
`5,299,121
`
`5,594,637
`
`5,619,991
`
`5,660,176
`
`5,758,095
`
`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.
`
`11-03-1998
`
`Cunningham
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`5,832,449
`
`5,845,255
`
`6,014,631
`
`6,055,507
`
`6,128,620
`
`5,974,203
`
`6,045,501
`
`6,063,026
`
`6,131,090
`
`6,202,923
`
`6,315,720
`
`6,561,978
`
`6,561,976
`
`6,561,977
`
`12-01-1998
`
`Mayaud
`
`01-11-2000
`
`Teagarden et al.
`
`04-25-2000
`
`Cunningham
`
`10-03-2000
`
`Pissanos et al.
`
`10-26-1999
`
`Tadokoro et al.
`
`04-04-2000
`
`Elsayed et al.
`
`05-16-2000
`
`Schauss 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
`
`Elsayed et al.
`
`05-13-2003
`
`Williams et al.
`
`Examiner
`Signature
`
`I
`
`/C. Luke Giiiigan/
`
`I Date.
`Constdered
`
`I 02/13/2012
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH. /C.L.G
`
`CFAD VI 1074 - 0001
`CFAD VI v. CELGENE
`IPR2015-01103
`
`

`
`Receipt date: 1 0/12/2011
`
`12966240 - GAU: 3626
`
`Substitute for 1449/PTO
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`Complete if Known
`12/966,240
`Application Number
`
`Filing Date
`
`December 13, 2010
`
`First Named Inventor
`
`Marc Elsayed
`
`Art Unit
`
`3626
`
`(use as many sheets as necessary)
`
`Examiner Name
`
`Christopher L. Gilligan
`
`Sheet
`
`I
`
`2
`
`I
`
`of
`
`I
`
`7
`
`Attorney Docket Number CELG-0641
`
`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
`
`22
`23
`24
`25
`26
`
`6,755,784
`
`6,767,326
`
`6,869,399
`
`6,908,432
`
`7,874,984
`
`06-29-2004
`
`Williams et al.
`
`07-27-2004
`
`Elsayed et al.
`
`03-22-2005
`
`Williams et al.
`
`06-21-2005
`
`Elsayed et al.
`
`01-25-2011
`
`Elsayed et al.
`
`FOREIGN PATENT DOCUMENTS
`
`Examine Cite
`r Initials
`No.
`
`27
`28
`29
`
`30
`31
`32
`
`33
`
`Foreign Patent Document
`
`Country Code- Number-
`Kind Code (if known)
`wo 96/13790
`wo 98/13783
`wo 99/10829
`wo 00/51053
`wo 98/58338
`wo 02/35440
`CA 2 352 619
`
`Publication
`Date
`MM-DD-
`yyyy
`
`Name of Patentee or Applicant of Cited
`Document
`
`T
`
`05-09-1996
`
`Med-E-Systems Corp
`
`04-02-1998
`
`Azron, Inc.
`
`03-04-1999
`
`DEKA Products LP
`
`08-31-2000
`
`Gemini Research LTD.
`
`12-23-1998
`
`Promedicus Systems Inc.
`
`05-02-2002
`
`Celgene Corp
`
`01-06-2003
`
`Tornado Technologies Inc.
`
`Exam in
`er
`Initials
`
`Cite
`No.
`
`34
`
`NON PATENT LITERATURE DOCUMENTS
`
`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
`
`"About the CNR," Website Printout:
`https://www.clozarilcare.com/care/NewUsrReqPersonal.jsp
`
`!C. Luke Gilligan/
`
`02/13/2012
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH. /C.L.G
`
`CFAD VI 1074 - 0002
`
`

`
`Receipt date: 1 0/12/2011
`
`12966240 - GAU: 3626
`
`Substitute for 1449/PTO
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`Complete if Known
`12/966,240
`Application Number
`
`Filing Date
`
`December 13, 2010
`
`First Named Inventor
`
`Marc Elsayed
`
`Art Unit
`
`3626
`
`(use as many sheets as necessary)
`
`Examiner Name
`
`Christopher L. Gilligan
`
`Sheet
`
`I
`
`3
`
`I
`
`of
`
`I
`
`7
`
`Attorney Docket Number CELG-0641
`
`NON PATENT LITERATURE DOCUMENTS
`
`Bakken, K., 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 (English abstract middle of page 1 076)
`
`Bastani, B., et al., "Development of the clozaril patient management system,"
`Psychopharmacology, 1989, 99, S122- S125
`
`Bates, D. W. et al., "Effect of Computerized Physician Order Entry and a Team Intervention
`on Prevention of Serious Medication Errors," JAMA, October 21, 1998, 280(15), 1311-1316
`
`Behm, G.A., Jr., No Title, Am. Pharmacy 131h APhA Annual Meeting Highlights, 1990,
`
`
`NS30(6), page 7
`
`Bender, K.J., "FDA approves reduced clozapine monitoring; increased patient access
`versus increased risk," Psychiatric Times, 1998, Vol. XV, Issue 5, page 13
`
`Black, L.L., et al., "A centralized system for monitoring clozapine use in British Columbia,"
`Psychiatric Services, 1996, 47(1), 81-83
`
`Bruera, E., and Neumann, C. M., ''The uses of psychotropics in symptom management in
`advanced cancer," Psycho-Oncology., 1998, 7, 346-358
`
`Clark, T. E .. , 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
`
`Complaint filed 1/18/2007 in NJ: Celgene Corp. v. Barr Laboratories, Case No. 2:07-cv-
`00286-PGS-RJ H
`
`Defendant Barr Laboratories, Inc.'s Answer, Counterclaims and Demand for Jury Trial filed
`3/01/2007 in NJ: Celgene Corp. v. Barr Laboratories, Case No. 2:07-cv-00286-PGS-RJH
`
`Dimopoulis, M.A., and Eleutherakis-Papaiakovou, V., "Adverse effects of Thalidomide
`administration in patients with neoplastic diseases," Am. J. Me d., October 1, 2004, 117,
`508-515
`
`Fax sent 10/14/04 from ian Hilley of GenPharm, Inc. to John Jackson of Celgene Corp. re:
`lsotretinoin Pregnancy Risk Management Program
`
`FDA's Forty-Seventh Meeting of the Dermatologic and Ophthalmic Drugs Advisory
`Committee, September 4-5, 1997
`
`Freeman, D.J., et al., "Will routine therapeutic drug monitoring have a place in clozapine
`therapy?," Clinical Pharmacokinetics, 1997, 32(2), 93-100
`
`35
`
`36
`
`37
`
`38
`
`39
`
`40
`
`41
`
`42
`
`43
`
`44
`
`45
`
`46
`
`47
`
`48
`
`Examiner
`Signature
`
`I
`
`!C. Luke Gilligan/
`
`I Date.
`Constdered
`
`I 02i13/2012
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH. /C.L.G
`
`CFAD VI 1074 - 0003
`
`

`
`Receipt date: 1 0/12/2011
`
`12966240 - GAU: 3626
`
`Substitute for 1449/PTO
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`Complete if Known
`12/966,240
`Application Number
`
`Filing Date
`
`December 13, 2010
`
`First Named Inventor
`
`Marc Elsayed
`
`Art Unit
`
`3626
`
`(use as many sheets as necessary)
`
`Examiner Name
`
`Christopher L. Gilligan
`
`Sheet
`
`I
`
`4
`
`I
`
`of
`
`I
`
`7
`
`Attorney Docket Number CELG-0641
`
`NON PATENT LITERATURE DOCUMENTS
`
`"Hoechst Arava Pregnancy Registry Recommended To Track Teratogenicity," "The Pink
`Sheet", August 17, 1998, Vol. 60, Number 033, page 23
`
`Honigfeld, G., et al., "Reducing clozapine-related morbidity and mortality: 5 years of
`experience with the clozaril national registry," J. Clin. Psychiatry, 1998, 59(Suppl. 3), 3-7
`
`Honigfeld, G., "Effects Of The Clozapine National Registry System on Incidence of Deaths
`Related to Agranulocytosis," Psychiatric Services, January 1996, 47(1), 52-56
`
`Janet Woodcock, Director, Center for Drug Evaluation and Research, "Supervisory Review
`of NDA 20-785," July 7, 1998
`
`Kumar, V., "Ciozaril monitoring systems, registry data and analyses," Presentation,
`Novartis, 2002, 44 pages
`
`Lieberman, J.A., 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, D.J., et al., "Computerized relational database for monitoring clozapine therapy," Am.
`J. Hasp. Pharm., 1993, 1657-1662
`
`Martin, S., "APhA says plan continues to interfere with pharmacists' practice prerogatives,"
`Am. Pharmacy, 1991, NS31(5), 30-31
`
`Medical Marketing & Media, "Managing a product under attack: a firsthand report on
`Clozaril: Interview with Sandoz Ltd.'s director of product marketing, Barbara Rosengren and
`assistant director Gilbert Honigfeld," September 20, 1991 ,Vol. 26, No. 10, page 6
`
`Mitchell, A. A. et al., "A Pregnancy-Prevention Program in Women of Childbearing Age
`Receiving lsotretinoin," N. Engl. J. Med., July 13, 1995, 333(2), 101-106
`
`Mordue, H.W., "Rational approach to clozaril distribution," Am. Pharmacy, 1990, NS30(6),
`page 7
`
`Notification letter dated 12/5/06 from Sterne Kessler to Celgene Corporation re: Notification
`Pursuant to§ 505U)(2)(B)(ii) of the Federal Food, Drug and Cosmetic Act
`
`Notification letter dated 12/15/06 from Sterne Kessler to Celgene Corporation re:
`Supplemental Notification Pursuant to§ 505U)(2)(B)(ii) of the Federal Food, Drug and
`Cosmetic Act
`
`49
`
`50
`
`51
`
`52
`
`53
`
`54
`
`55
`
`56
`
`57
`
`58
`
`59
`
`60
`
`61
`
`/C. Luke Gilligan/
`
`02/13/2012
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH. /C.L.G
`
`CFAD VI 1074 - 0004
`
`

`
`Receipt date: 1 0/12/2011
`
`12966240 - GAU: 3626
`
`Substitute for 1449/PTO
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`Complete if Known
`Application Number
`12/966,240
`
`Filing Date
`
`December 13, 2010
`
`First Named Inventor
`
`Marc Elsayed
`
`Art Unit
`
`3626
`
`(use as many sheets as necessary)
`
`Examiner Name
`
`Christopher L. Gilligan
`
`Sheet
`
`I
`
`5
`
`I
`
`of
`
`I
`
`7
`
`Attorney Docket Number CELG-0641
`
`NON PATENT LITERATURE DOCUMENTS
`
`Notification letter dated 12/19/06 from Sterne Kessler to Celgene Corporation re:
`Supplemental Notification Pursuant to§ 505U)(2)(B)(ii) of the Federal Food, Drug and
`Cosmetic Act
`
`Notification letter dated 10/04/2007 from Barr Laboratories to Celgene Corporation re:
`Supplemental Notification Pursuant to§ 505U)(2)(B)(ii) of the Federal Food, Drug and
`Cosmetic Act
`
`Oyesanmi, 0., et al., "Hematologic side effects of psychotropics," Psychosomatics, 1999,
`40,414-421
`
`Pastuszak, A. 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, Y.Z, et al., "Durable Clinical response of refractory hepatocellular to orally
`administered thalidomide," Am. J. Clin. Oneal. (CCT., 2000, 23(3), 319-321
`
`Peck, C.C., et al., "FDA's position on the clozaril patient management system," Hospital &
`Community Psychiatry, 1990, 41(8), 876-877
`
`Physician's Desk Reference, 1997, pp. 2252-2254, 2377-2380
`
`Press Release dated 11/23/04, "lsotretinoin Makers Reach Agreement with Celgene on
`S.T.E.P.S. Risk Management Patents,"
`
`Reference Guide ''THALIDOMID™ (thalidomide): Clinical Information and Prescribing
`Guidelines," Celgene Corporation, 9/98
`
`Richardson, P, et al., "Thalidomide: Emerging role in cancer medicine," Annu. Rev. Med.,
`2002, 53, 629-657
`
`Richardson, P., et al., "Thalidomide: The revival of a drug with Therapeutic promise in the
`
`treatment of cancer", In: Cancer: Principles and Practice of Oncology, 61h Ed., DeVita VT,
`Hellman S, Rosenberg SA, editors. Lippincott, Williams, and Wilkins, Philadelphia PA, 2001,
`1-18.
`
`Roche's Press Release Regarding Pregnancy Prevention Program for Women for Women
`on Accutane, October 31, 2001
`
`Singhal, S. and Mehta, J., "Peer Viewpoint," J. Supportive Oncology, 1(3),
`September/October 2003, 200-201
`
`62
`
`63
`
`64
`
`65
`
`66
`
`67
`
`68
`
`69
`
`70
`
`71
`
`72
`
`73
`
`74
`
`iC. Luke Giiiigani
`
`02/13/2012
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH. /C.L.G
`
`CFAD VI 1074 - 0005
`
`

`
`Receipt date: 1 0/12/2011
`
`12966240 - GAU: 3626
`
`Substitute for 1449/PTO
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`Complete if Known
`12/966,240
`Application Number
`
`Filing Date
`
`December 13, 2010
`
`First Named Inventor
`
`Marc Elsayed
`
`Art Unit
`
`3626
`
`(use as many sheets as necessary)
`
`Examiner Name
`
`Christopher L. Gilligan
`
`Sheet
`
`I
`
`6
`
`I
`
`of
`
`I
`
`7
`
`Attorney Docket Number CELG-0641
`
`NON PATENT LITERATURE DOCUMENTS
`
`75
`
`76
`
`77
`
`78
`
`79
`
`80
`
`Sittig, D. F. et al., "Computer-based Physician Order Entry: The state of the Art," J. Amer.
`Med. Inform. Assoc., Mar/Apr 1994, 1(2), 108-123
`
`Somers, G. F., "Pharmacological Properties of Thalidomide (a-Phalidimido Glutarimide) a
`New Sedative-Hypnotic Drug," Brit. J. Pharmacal., 1960, 15, 111-116
`
`System for Thalidomide Education and Prescribing Safety, ''THALIDOMID™ (thalidomide):
`Balancing the Benefits and the Risks," Celgene Corporation, 11/98
`
`Teo, S. K., et al., "Clinical pharmacokinetics of thalidomide," Clin Pharmacokinetics, April
`2004, 43(5), 311-327
`
`Thalomid information from Drugs.com [online], Drugs.com, 22 June 2006 [retrieved on
`2008-02-01], Retrieved from the internet: <URL: htt[:!:Jiwww.drugs.com/tha!omid.htm!>
`
`"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
`
`tab. 17
`
`81
`
`Thalidomide: Potential Benefits and Risks. An Open Public Scientific Workshop, Program
`and Abstracts, September 9-10, 1997
`
`tab. 3
`
`82
`
`tab. 18
`
`83
`
`84
`
`85
`
`86
`
`87
`
`Thalidomide: Potential Benefits and Risks. An Open Public Scientific Workshop, Transcript:
`NIH Testimony from September 9, 1997:
`
`httg://www.fda.gov/oashi!QatreQ/nih99.html
`
`Thalidomide: Potential Benefits and Risks. An Open Public Scientific Workshop, Transcript:
`NIH Testimony from September 10, 1997:
`
`httQ://\1\!VVW.fda.gov/oashiiQatreQ/n ih91 0 .html
`
`Thomas, M. and Doss, D, "Thalidomide Nursing Roundtable Update," American Academy of
`CME, Inc. and OmegaMed Inc., publishers., September 2002
`
`Trussell, J., "Contraceptive Efficacy," Arch. Oermatol., Sep 1995, 131, 1064-1068
`
`Uhl, K. 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, L. G. 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
`
`!C. Luke Giiiigan/
`
`02/13/2012
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH. /C.L.G
`
`CFAD VI 1074 - 0006
`
`

`
`Receipt date: 1 0/12/2011
`
`12966240 - GAU: 3626
`
`Substitute for 1449/PTO
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`Complete if Known
`Application Number
`12/966,240
`
`Filing Date
`
`December 13, 2010
`
`First Named Inventor
`
`Marc Elsayed
`
`Art Unit
`
`3626
`
`(use as many sheets as necessary)
`
`Examiner Name
`
`Christopher L. Gilligan
`
`Sheet
`
`I
`
`7
`
`I
`
`of
`
`I
`
`7
`
`Attorney Docket Number CELG-0641
`
`NON PATENT LITERATURE DOCUMENTS
`
`88
`
`Zeldis, J. B. et al., "S.T.E.P.S. ™: A Comprehensive Program for Controlling and Monitoring
`Access to Thalidomide," Frontiers in Fetal Health: A Global Perspective, The Fetal Centre at
`The Hospital for Sick Children, Toronto, Canada, Vol. 1, Number 2, August 1999
`
`!C. Luke Gilligan/
`
`02/13/2012
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH. /C.L.G
`
`CFAD VI 1074 - 0007