`
`12966240 - GAU: 3626
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`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
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`of
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`1
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`7
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`Attorney Docket Number CELG-0641
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`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)
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`Name of Patentee or Applicant of Cited Document
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`2006/0129433
`
`06-15-2006
`
`Koneru
`
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`
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`14
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`15
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`16
`
`17
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`18
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`19
`
`20
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`21
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`5,832,449
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`
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`
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`
`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
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`2
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`I
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`of
`
`I
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`7
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`Attorney Docket Number CELG-0641
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`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
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`27
`28
`29
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`30
`31
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`
`33
`
`Foreign Patent Document
`
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`wo 96/13790
`wo 98/13783
`wo 99/10829
`wo 00/51053
`wo 98/58338
`wo 02/35440
`CA 2 352 619
`
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`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
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`3
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`I
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`of
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`I
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`7
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`Attorney Docket Number CELG-0641
`
`NON PATENT LITERATURE DOCUMENTS
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`41
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`42
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`43
`
`44
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`45
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`46
`
`47
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`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
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`7
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`Attorney Docket Number CELG-0641
`
`NON PATENT LITERATURE DOCUMENTS
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`Sheet", August 17, 1998, Vol. 60, Number 033, page 23
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`J. Hasp. Pharm., 1993, 1657-1662
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`Am. Pharmacy, 1991, NS31(5), 30-31
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`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
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`page 7
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`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
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`49
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`50
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`51
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`52
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`53
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`54
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`55
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`56
`
`57
`
`58
`
`59
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`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
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`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
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`7
`
`Attorney Docket Number CELG-0641
`
`NON PATENT LITERATURE DOCUMENTS
`
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`
`!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
`
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`
`!C. Luke Gilligan/
`
`02/13/2012
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH. /C.L.G
`
`CFAD VI 1074 - 0007