`
`www. archiveorg
`415.561.6767
`413840-0391 c-fmt
`
`lntemet Archive
`
`300 Fumm Mam
`5,,“ Fmdsco, CA 94113
`
`AFFIDAVIT OF CHRISTOPHER BUTLER
`
`l. I am the Office Manager at the Internet Archive, located in San Francisco,
`California. I make this declaration of my own personal knowledge.
`2. The Internet Archive is a website that provides access to a digital library of
`Internet sites and other cultural artifacts in digital form. Like a paper library, we provide
`fi'ee access to researchers, historians, scholars, and the general public. The lntemet
`Archive has partnered with and receives support from various institutions, including the
`Library of Congress.
`3. The lntemet Archive has created a service known as the Wayback Machine. The
`Wayback Machine makes it possible to surf more than 150 billion pages stored in the
`lntemet Archive's web archive. Visitors to the Wayback Machine can search archives
`by URL (Le, a website address). If archived records for a URL are available, the visitor
`will be presented with a list of available dates. The visitor may select one of those
`dates, and then begin surfing on an archived version of the Web. The links on the
`archived files, when served by the Wayback Machine, point to other archived files
`(whether HTML pages or images). If a visitor clicks on a link on an archived page, the
`Wayback Machine will serve the archived file with the closest available date to the page
`upon which the link appeared and was clicked.
`4. The archived data made viewable and browseable by the Wayback Machine is
`compiled using software programs known as crawlers, which surf the Web and
`automatically store copies of web files, preserving these files as they exist at the point of
`time of capture.
`5. The lntemet Archive assigns a URL on its site to the archived files in the format
`http://web.archive.org/web/ [Year in yyyy] [Month in mm] [Day in dd][Time code in
`hh:mm:ss]/[Archived URL]. Thus, the Internet Archive URL
`http://web.archive.org/web/19970126045828/http://www.archive.org/ would be the
`URL for the record of the lntemet Archive home page HTML file
`(http://wwwarchiveorg!) archived on January 26, 1997 at 4:58 am. and 28 seconds
`(1997/01/26 at 04:58:28). A web browser may be set such that a printout from it will
`display the URL of a web page in the printout’s footer. The date assigned by the lntemet
`Archive applies to the HTML file but not to image files linked therein. Thus images that
`appear on a page may not have been archived on the same date as the HTML file.
`Likewise, if a website is designed with "frames," the date assigned by the lntemet
`Archive applies to the frameset as a whole, and not the individual pages within each
`frame.
`A
`
`6. Attached hereto as Exhibit A are true and accurate copies of printouts of the
`lntemet Archive's records of the HTML files for the URLs and the dates specified in the
`footer of the printout.
`7. I declare under penalty of perjury that the foregoing is true and correct.
`
`mm:
`
`' 72....
`
`Christopher Butler
`
` , _ A 128
`
`
`
`
`IPR of US. Patent No. 7,765,106
`Page 1 of 362
`
`AMN1028
`IPR of U.S. Patent No. 7,765,106
`Page 1 of 362
`
`
`
`CALIFORNIA J URAT WITH AFFIANT STATEMENT
`
`See Attached Document.
`
`State of California
`
`County of San Francisco
`
`,_
`
`NANCY CHEWG
`COMM “3757” {a
`.,
`V wmm'm "
`
`Subscribed and swem—te—(er affirmed) before me this
`PW
`Lday ofL, 3’1"; by
`
`CM wk SflLfl/V 15AM er
`
`,
`
`proved to me on the basis of satisfactory
`evidence to be the person who appeared
`before me.
`
`
`
`Signature: LW -
`
`gmamslmd I
`
`~,
`
`_~
`
`i
`
`AMN1028
`_-I-l'—-————I—I—-——————————I———I—
`
`IPR of US. Patent No. 7,765,106
`Page 2 of 362
`
`AMN1028
`IPR of U.S. Patent No. 7,765,106
`Page 2 of 362
`
`
`
`Exhibit A
`
`AMN1028
`
`IPR of US. Patent No. 7,733, ”55
`Page 3 of 362
`
`AMN1028
`IPR of U.S. Patent No. 7,765,106
`Page 3 of 362
`
`
`
`FDA Advisory Committees
`
`1 of l
`
`[ Home | 1 Federal Registers |
`
`| FDA Home Page |
`
`[ NO'I'E: Many ofthe documents are in PDF format. the ADOBE ACROBAT Reader is needed to review I’DF files. Click on the ADOBE icon below and download
`the free reader. ]
`
`'W
`. Executive Secgtgries (Updated ail/flu)
`
`o
`
`v'
`
`‘
`
`es
`
`rm
`
`0 Meeting Transcflpts/Minutes/Other Docs by Center
`01997 [Transcrigts ]/ [_Minutes I
`0 Q9; (Transcripts / Minutes)
`0 1292 (Meeting documents by Center)
`0 mg (Meeting documents by Center)
`0 M1 (Meeting documents by Center)
`I Selected Tunnel-bl:
`0 M
`0 33.2%
`o Redux (Three Frequently Requested Tra use I'ipts)
`0 1996 (including Mifenristone]
`
`*—
`
`http:/iweb.archive.org/web/20010309l l26OO/http2/www.fda.gov/ohnns/dockets/ac/acmenu.hun
`
`AMN1028
`IPR ofU.S. Patent No. 7, 733, [355
`Page 4 of 362
`
`AMN1028
`IPR of U.S. Patent No. 7,765,106
`Page 4 of 362
`
`
`
`2001 Advisory Committee MEETING TRANSCRIPTS / MINUTES B...
`
`1 of] “x
`
`[Home ] [£2] [(fBER 2001 Meeting Documents] [CDER 2001 Meeting Documents]
`[CDRH 200i Meeting Documents ][()C 2001 Meeting Documents]
`[ Federal Registers ] I FDA Home Page ”What's New]
`
`
`2001 MEETING TRANSCRIPTS f MINUTES BY CENTER
`
`
`0 Alleggnic Products Advisgn Committeee(Lpdated 10/15/01)
`0
`iologicgl Rgsmlnse Modifiers Adv'uun- [1‘ommittee (Updated 07/30/01)
`Bloodn:_’r0ducts AdvIsg5' Committeee(Updated 08/14/01)
`ihle
`iform Ence halo
`thies Advis
`0
`(ommtttee (Updated 10/12/01)
`- Vaccines & Related Biologic Products .Advisgu- Committee (Updated 08/17/01)
`
`Anesthetic and Life Sum!“ Drugs Adviso a Committee (Updated 08/24/01)
`Anti-lnfectivg DruggAgV'isgn g'pmmittge (Updated 10/15/01)
`Anti-Viral Drugs= Advisog- Committee (Updated 10/17/01)
`Arthritis Adviso 1;}- Committee (Updated 09/27/2001)
`iteee(Updated10/10/01)
`' v 5
`SA v'
`'
`‘so (ommittee (Updated 09/27/01)
`
`Voguectjmio 9 flags Advison Committeee(Updated 10/18/01)
`()ngg I512:mg Advfiflfl' 1gmmittee (Updated 09/27/01)
`Peripheral and Central Nervous Sistem Drugs Adv'gnn g ‘gmmittee (Updated 07/13/01)
`.Adv'Isog (.ommittee for Phannaceutical Sciencee(Updated 10/03/01)
`PslxghonhgnngggSEE! Dgggs 3g1Ison Committeee(Updated 7/23/01)
`P Imn
`-.A| D l-
`viso Comm'
`e(1;pdated10/18101)
`
`(New 07/30/01)
`
`vi e
`i
`and R
`Anesth in
`(iIuguigmg Entgm Desiggs Panel (Updated 09/27/01)
`Wilt/1111mm (Updated 09107/00
`WWW (Updated 08/07/01)
`htlem'gglne5' ss [z'gpute Resolutg' nEanel
`(Updated 09/21/01)
`Jmhidtmmm (New 10/11/01)
`'
`'
`-
`‘
`\a ‘on 1M m o
`-
`
`Qgsletrigs-anecglgggDevices Panel (Updated 6/5/01)
`Oghthalmic DesIces Panel (Updated 08/14/01)
`Qrthgpgdic and Rsh'dizilitatifln Dukes [age] (Updated 08/12/01)
`Rast'thggic Device; Page! (Updated 6/13/01)
`Technical Electronic Pgduct Radiation @1311 Standards Committee (Updated 08/07/01)
`
`(i:pdated09/21/01)
`
`-W (New 08/02/01)
`0 Science B9193] to FDA (Updated 10/11/01)
`
`Imam-111 [Eiddfl 1
`
`Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305. Rockville, MD. 20852: 30l-827-6860; Fax 301-827-6870
`
`(Updated 10/18/01 )
`
`http://web.archive.org/web/200l 1020203932/http:/www.fda.gov/ohrms/dockets/ac/O I docsbchtm
`
`AMN1028
`
`IPR ofU.S. Patent No. 7, 755, [06
`Page 5 of 362
`
`_
`
`AMN1028
`IPR of U.S. Patent No. 7,765,106
`Page 5 of 362
`
`
`
`2001 Advisory Committee MEETING TRANSCRIPTS/ MINUTES B...
`
`l of l
`
`I Home] [E2] [CBER 2001 Meeting Documentsl [CDER 2001 Meeting Documents]
`[CDRH 200i Meeting Documents "QC 200] Meeting Documentsl
`[ Federal Registers ] | FDA Home P531- ]IWhat's New!
`
`
`2001 MEETING TRANSCRIPTS / MINUTES BY CENTER
`
`
`o .» Hellenic Products Advisgn' Sggmmigeg (Updated 10/15/01)
`«1
`iological Resmgnse Modifiers Agv §'9': (‘ommillee (Updated 11/23/01)
`:13th nguct§ Adv'ggmgommittel: (Updated 12/10/01)
`‘ mmittee (Updated 11/26/01)
`issible S
`
`I
`'agcing; & Relgteg Biomgg Pmdulcots Advisgg Comm'ggee (Updated 11/27/01)
`
`. Anesthetic and Life Summit Dmgs Advisou' Cgmmitteg (Updated 08/24/0l)
`. Ami-1131111 g 91328 Adv-ism; Committee (Updated 12/10/01)
`o A nti—Vital Drugs Advisog- Committee (Updated 12/11/01)
`0 Arthritis Adviso 5- Committee (Updated 09/27/2001)
`0
`‘ardiovascugr and Renal Drugs Adv‘ggn- 5"gmmittgg (Updated 10/24/01)
`0
`‘ndocn’nologic and Metabolic Dru“ Advisgn- Committee (Updated 09/27/01)
`c 1 onnmscrimion Dru“ Advison' 1.0mmittee (Updated 10/18/01)
`- Wwwnw 12105/01)
`- Perinheral and Central Nervgug Svstgm Drugs AdViflgn Committee (Updated 07/13/01)
`- Adv'ggn Committee for Phanngcemical Science(Updated 12/12/01)
`- P§1ghomgmacolongm2: Agviggg go mmlttee (Updated 7/23/01)
`0
`ulm(ma n-AIIem1 [25121 Avgviggngggmm'mgee(Updated10/18/01)
`
`(New 07/30/01)
`
`(Updated 09/21/01)
`
`- AngsghSHEER! and Rem[3195 “1:53p! Deuces Pangl
`05‘im”lama fi1hfigm ngi§§§ Pgngl (Updated 11/26/01)
`P n 1(Updated11/23/01)
`. (linic l
`.
`"
`
`figstmmentgmlon-L' mlol1 Devices Panel
`(Updated 10/26/01)
`signgal and Plastic Sunni-[1 Devices Panel
`(Updated 08/07/0l)
`o uledical Devices Disnute Resolutm' n Pangl
`(Updated 11/26/01)
`-W: Panel
`(New 11/05/01)
`-
`'at‘mngl Wimmngumyflgglin AgsmgngeAgvgj'15-179mmittee
`.
`tetric - '
`-
`D vi
`s Panel (Updated 6/5/01)
`0 gzmthalmic Dev'mgg Panel (Updated 11/29/01)
`-WWW (Updated 08/22/01)
`0 fladiomgic Devices Panel (Updated 01)
`. Trchni
`m icP du t
`
`‘
`
`'Sta d
`
`‘
`
`' ee(Updated08/07/01)
`
`W11: (New 08/02/01)
`W (Updated 12/05/01)
`
`[Acgflgihilig] [E—mgil ]
`
`Dockets Management Branch. 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860; Fax 301-827—6870
`
`(l'pdated lZ/lZ/Ol )
`
`http://web.archive.org/web/2001l214125612/http:/www.fda.gov/ohrms/dockets/ac/Oidocsbchtm
`
`AMN1028
`
`—-—————HW
`Page 6 of 362
`
`AMN1028
`IPR of U.S. Patent No. 7,765,106
`Page 6 of 362
`
`
`
`2001 Advisory Committee MEETING TRANSCRIPTS/ MINUTES B...
`
`l of 1
`
`
`[Home | [£2] ICBER 2001 Meeting Documents | [(‘DER 200! Meeting Documents]
`[(‘DRH 200i Meeting Documents ”EK'ZOOI Meeting Documentsl
`| Federal Registers] | FDA Home Page "What's V'QV/I
`
`
`2001 MEETING TRANSCRIPTS / MINUTES BY CENTER
`
`
`0 Allegeenic Products Adv bog Committee (Updated 10/15/01)
`0 Biological Resmnse Modifiets Adv'sog giggmmittee (Updated 11/23/01)
`0 Blood Products Advisory Committee (Updated 01/08/02)
`
`
`
`0 T nsmissibleS
`
`halon iform Enc
`thie Adv' o
`f mmittee (Updated 03/29/02)
`0 Vaccines & Related Biologic Products Advison Committee (Updated 01/03/02)
`
`vi 0 ' To mittee (Updated 08/24/01)
`rtI)
`1 nest etic and Lif
`'(f mmit ewpdated 05/23/02)
`sA v‘
`A i-Infe
`iv
`Anti-Viral bulge Adv ‘sgn gi‘ommittee (Updated 01/23/02)
`Arthritis Adv igog Committee (Updated 09/27/2001)
`[3535‘gva§gulflr gnd Repel Dfllfl 55M}05: g‘gmmittee (l'pdated 12/21/01)
`Endocrinologic and Metabolic Drueg Advisgg- (Tommigee (Updated 09/27/01)
`Nonprescription DES Advisog Committee (Updated 10/18/01)
`WWWM 01/18/02)
`Perimeml and Centfll Nervous Sestem Dame Advigon- ('ummittee (Updated 07/13/01)
`W (Updated 12/21/01)
`W (Updated 7/23/01)
`Wilma/3mm. (Updated 10/18/01)
`
`
`
`el
`
`(New 07/30/01)
`
`I
`
`I ‘
`
`(Updated09/21/01)
`
`'
`'
`'
`I(Updated 12/20/01)
`-W Itlpdazed 10/26/01)
`- Gen
`l
`v
`Pn(l:pdated12/20/01)
`a \l
`D vi
`Re
`i
`(L'pdated 11/26/01)
`- Mkruhioilm Devices Panel
`(.‘aew 11/05/01)
`0 N-
`' 11 IM
`-Co
`‘
`
`o Obstetrics-ghnecolog} Devices Panel (Updated 6/5/01)
`e Wtuwmd 12/20/01)
`-WWW (Updated 08/22/01)
`- Radiglogic Devices Panelwpdated 01)
`e "
`'
`ct
`'
`‘
`'
`
`S
`
`-
`
`t
`
`rds Committee (tipdated 03/07/01)
`
`_
`
`e BMW (New 08/02/01)
`
`0 Sc_i_e_n_ce Board to FDA (lpdlted 02/07/02)
`
`[Accessibiliti-I lE-mail]
`
`Dockets Management Branch. 5630 Fishets Lane - Room l06l- HFA-305, Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870
`
`Updated 05/23/02
`
`http://web.archive.org/web/20020602142527/http:/www.fda.gov/ohrtm/dockets/ac/Oldocsbc.htm
`
`AMN1028
`
`IPR of US. Patent No. 7,755, [05
`Page 7 of 362
`
`AMN1028
`IPR of U.S. Patent No. 7,765,106
`Page 7 of 362
`
`
`
`New Page 1
`
`l of 6
`
`
`
`1 Federal Registers |
`
`| F DA Home Page ”Dockets Home PageHLBERHCDRHlflflLQI
`
`CDER 2001 Meeting Documents
`
`
`'l’mnwniit I’IH II)
`luau-mu In: H!
`
`(sin in lih‘i
`um- in km
`Du)
`Hurt
`
`Pages 1- 100
`3746tl.g_f (388) & hlml
`4/26
`4126
`
`3746tl_01.mfl
`(392)
`
`(10,540)
`
`
`Pages 10l-200
`3746t1_02.m_f
`
`(109646)
`
`Pages 20l-339
`3746tl_03.pg[
`(19,170)
`
`\Ii'nulz ~
`(‘Ili‘ m Ill-l
`
`
`
`
`()ilu-r ”In" II)
`Agenda
`3746al.ndj', tam
`
`Briefing Info.
`3746M .mm
`
`Roste r
`3746r1_01committee.wf,
`lit—m
`37461-1 _02quest.1&f, hl_m
`Slides
`
`
`
`__
`
`|
`
`3746s1._l1t_m_
`Notice ofMtg.
`|03230ld.ht_m & pd_f
`
`4/23
`
`
`
`4/24
`
`3744t1_0l.pg_f& Lil_m mung
`
`
`
`Briefing lnl'onnation
`:3744bl .ht_m
`
`
`
`Agenda
`3744:1109; htJL'l
`
` Roster
`
`3744rlqfl", ht_m
`
`
` Questions
`3744q1 MI, ht_m
`
`Slides
`
`
`
`3744s1.p_(if
`
`Briefing Information
`3744t2.wf& m
`
`3744b2.ht_m
`
` Agenda
`374482.1fl, him
`
`Roster
`
`
`
`3744r2.p1f, hl_m
`
`iQuestions
`-3744q2.pg. ht_m
`
`.
`
`Slides
`374452.”!
`Briefing Package
`:37l9bl.htm
`!
`
`Roster
`§7l9rl hgm
`
`Slides
`3719slghtm
`
`Agenda
`mam
`
`I
`'
` E
`01/30 :37l9tl 0].;ng6126)
`37l9tl.g_f(439)
`3719ml.mm1
`37l9tl 02.;nlf(6374)
`.37l9tl 03.:gf(6385)
`lE719” jl4.mlf(6428)
`
`| I
`
`'
`
`
`
`4/23
`
`I
`
`'01/30
`
`I
`
`http:/!web.archive.org/web/200106172 10030ihttpszww.fda.gov/ohrms/dockets/ac/cderO Lhtm
`AMN1028
`
`IPR of US. Patent No. 7,765,106
`Page 8 of 362
`
`AMN1028
`IPR of U.S. Patent No. 7,765,106
`Page 8 of 362
`
`
`
`New Page 1
`
`2 of 6
`
`Question 3719 |l.htm
`
`'lo )
`
`MMM
`
`
`
`
`
`lmuwnpl I’IJI
`II)
`1m “scrip! 'lnt III
`\lllllll(‘\
`
`
`("her l)lu‘\ ll)
`(Ni/1' in MN
`«xi/e in kln
`{sin- in It!"
`
`
`
`
`12/27
`Agenda
`3731:|.nf(271)
`
`
`.373 tl 0|.p_tif (6394)
`
`
`:373 1 a 1 .M. pit“
`373m 02.5.“ (6275)
`
`3731 t] 03.95” (3920)
`
`Slides
`3731s] .ht_m
`
`
` Roster
`
`3731 r1 .E, M
`
`3731 r2.(lic, [fl
`
`
`Briefing lnfonnation
`3731 b1.ht_m
`
`Questions
`
`
`3731 (II -M, HQ!
`
`
`Agenda
`367611 a.|xlf
`
`
`3676al.g(5,ul_f
`
`
`
`Roster
`
`
`
`
`-3676r1.(l(_)c, ILlf
`
`
`Briefing Information
`__3676b1.htm
`
`
`'
`
`
`
`Slides
`3676sl.htm
`367651 034w
`
`
`
`3678t1_a.2g_l_f
`3678t1_b.1&f
`3678t1_c.w
`3678t1_d.ml_f
`
`3578t1.1f
`
`Agenda
`3678aLfl, lef
`
`Briefing Information
`3678b] .ht_m
`
`Slides
`367881.ht_m
`
`
`
`Ulhrr ”m s ll)
`
`\Iinulcs
`lrunwripl 11:“ ll!
`'l'ralhtl'ipt l'l“ II)
`{xi/c in l\l\)
`Isizc m Llo)
`ism- in km
`
`4/19
`4/20
`.3740t1_01.p(_lf
`,3740t1._r1_f
`Agenda
`I3740t1_02.1Llf
`.
`.3740a1.ht_m & 1x_1r
`l3740t1_03.1fl
`|
`
`'Briefing Information
`3740bl.m
`
`I
`
`Questions
`f3740ql .ht_m & [x_lf
`
`iRoster
`3740r1_01ht_m & pfl‘
`3740r1_02 ht_m & pfl‘
`
`Slides
`374051 .htm
`
`hrtp:l/web.archive.org/web/200106172 l0030/http:/www.fda.gov/ohmis/dockets/ac/cdero l .htm
`
`A
`
`1028
`
`IPR of US. Patent No. 7,765,106
`Page 9 of 362
`
`AMN1028
`IPR of U.S. Patent No. 7,765,106
`Page 9 of 362
`
`
`
`3 of6
`
`||
`
`lAgenda
`3677a1.d_oc_. M”
`()5 er
`R t
`i3677rl_01.fl, p_d_f
`Guest Roster
`
`i3677r1_02.fl, IL”
`
`-
`
`Briefmg Information
`3677bl.ht_m
`
`New Page 1
`
` 2/‘7
`
`
`
`3677tl_01.pfl‘(6421)
`3677:1_02.;gr(6733)
`3677:1_03.;gr(244s)
`
`136—77t1nfi561)
`‘
`.1
`4
`'
`
`
`
`
`
`
`
`Slides
`
`3677s] .m
`
`
`
`
`
`[Briefing Package
`
`02/08 I367712 01.;._.!r(o774)
`g677eg.nr(597)
`
`i3677b2.htm
`- 677t2 ()2.E!f(6852)
`'_3677t2 03.11:“ (29l8)
`
`
`
`Questions
`3677q1.1¢r_c,1x_“‘
`
` 3677a2.5i0g & [x_lf
`
`
`
`
`Questions
`3677:|2 0|.doc & w
`367792 02.doc & M
`
`mum-nut l‘l'il‘
`{si'fl‘ in Mn
`
`ll!
`
`[raw-nil" In! I“
`{~.i11' in lain
`
`\linuu—s
`(size in kh)
`
`Dug
`5/24
`
`5/25
`
`.3749q2-nd_f& m_m
`
`Ulhr r Dun ll)
`Briefing lnfon‘nation
`3749b1.m
`
`Agenda
`3749a].pfi& m
`
`Questions
`3749ql.plf & ht_m
`Briefing Information
`3749b2.ht_m
`
`:Questions
`
`Trunwrip!‘ Pl)!
`him in km
`
`
`
`ll)
`
`lrmm'npi int ll)
`hue in kivL
`
`\limr‘i’rw
`him I“ Hi)
`
`()[Ilrr Dm-x ll)
`:Agenda
`
`'3737al.htm, pg‘
`
`iPlanning Agenda
`!3737al_planning.m, Lxfl
`
`
`
`
`
`
`
`
`Briefing Information
`3737b] .htm
`m
`
`
` .
`
`IQuestions
`3737q1.ht_m. {fl
`
`hrtp2/;'web.archive.orywebJ'ZOO 106 172 l 00301’http2/w ww.fda.gov/ohrms/dockets/ac/cdero1 .htm
`
`AMN1028
`
`IPR of US. Patent No. 7,765,106
`Page 10 of 362
`
`AMN1028
`IPR of U.S. Patent No. 7,765,106
`Page 10 of 362
`
`
`
`New Page 1
`
`4 01‘6
`
`
`
`
`lransrripi ]'IDI
`111
`lrnnwripi In! ll)
`\linuln
`(xi/c in MM
`()IIIH' Duck Ill
`Iwc in I‘M
`hin- in km
`
`
`
`Agenda
`
`I3757al.ht_m & M‘
`
`
`
`
`
`”among
`
`
`3743113233
`
`l3743tl_03.2d_f
`
`Questions
`33757q1.ht_m & p_d_f
`
`Briefing lnfonnation
`
`3757b1.gtm & pi!
`Agenda—__
`3743a1.m_m & [gr
`
`Briefing Information
`
`.3743b1 .ht_m & pg
`
`II
`'
`
`'I‘rnnwnpl H)!
`mm- in LN
`
`II)
`
`II.|n~"rIpl lui II)
`[am in MM
`
`\lllHHt“
`hm in kln
`
`Uilwr Duos 11)
`
`3/13
`
`3/13
`
`3724tl.pd_f
`
`3724:].lf
`
`3724ml.1i__tfl
`3742mlqfl
`
`.
`
`f
`
`3/14
`
`3724t2.&f
`
`3‘724t2.mr
`
`3724m2.ht_m
`3724m24fl‘
`
`
`
`I Top 1
`
`3724r1_01.m. M
`
`Briefing Info
`3724131 .ht_m
`
`Slides
`3724sl.ht_m
`
`Agenda (DRAFT)
`372422.Qg, fl
`
`Roster
`
`3724rl_02.fl, Lug
`
`Briefing Info
`3724b2.ht_m
`
`Slides
`372482-M
`
`http:f/web.archive.org/web/20010617210030fhttp1/www.fda.gov/ohrms/dockets/ac/cderol .htm
`
`
`AMN1028
`
`IPR of US. Patent No. 7,765,106
`Page 11 of 362
`
`AMN1028
`IPR of U.S. Patent No. 7,765,106
`Page 11 of 362
`
`
`
`New Page 1
`
`50%
`
`Inulu-n'pl I’Dl‘
`(sill: in km
`
`II)
`
`Inunrnpl In! Ill
`lun- in Mn
`
`\lmuhw
`him in I‘m
`
`{)II'II: 1‘ I’m s H)
`
`Hangings: hlrnl{lllfl}
`
`3742a1.ht_m & M
`
`Roster
`
`3742r1.ht_m & pg”
`3742r2.ht_m & Ifl‘
`
`Briefing Info
`3742bl.ht_m & w
`
`Notice of Meeting
`98frx03 2301g.h_tm
`98frx032301g.pd_f
`
`
`
`Ila}
`
`'l’uuluiipl PDI' Ill
`him in km
`
`!2/14
`
`2/14
`
`3685t1.w‘.1x_t
`
`
`Ilullu'l'lpl In! Ill
`\liuutm
`
`bin: in I‘M
`him in kl»)
`()[le‘li Dun II) ,,
`
`Agenda
`3685ml.pd_l'
`3685al.m, pd_f
`
`Roster
`
`3685rl.d£, flail
`
`Questions
`i3685q1-th_w, [if
`
`_2/15
`
`3585:2.lw.m
`
`.3685m2.p¢_i_f
`
`'
`
`l()|)
`
`lBrieiing Info
`3685b1.fly_ll
`
`
`
`
`Slides
`36853.ht_m
`
`Agenda
`368582.Lw_, p(_|f
`
`Roster
`
`3685!2.do_c, {if
`
`Questions
`
`3635q2-m. w
`
`Briefing Info
`
`3685b2.ht_m
`
`etition
`
`()[IICI' Dun ll)
`
`Age nda
`3737aLM, M
`
`Planning Agenda
`3737a1_planning.ht_m, pg"
`
`Questions
`3737q1.m_m, pg
`
`Briefing Information
`
`mP
`
`05/11
`
`I'l'flll‘s‘t‘l’im I’Dl-
`“in In kin
`
`ll)
`
`II'JIIH. lip! {ml II)
`nin- in LI”
`
`\Iinulcs
`ui/c in M);
`
`http:/‘lweb.archiVe.org/webfZOO [06172 1003 thttp:I'WWW.fda.gov/ohm15/dockets/ac/cderO 1 .htm
`
`
` AMN1028
`
`IPR of US. Patent No. 7,765,106
`Page 12 of 362
`
`AMN1028
`IPR of U.S. Patent No. 7,765,106
`Page 12 of 362
`
`
`
`New Page 1
`
`6 of 6
`
`http:l/web.archive.org’web/200106172 l0030/httpzlwww.fda.gov!ohrms/dockets/ac/cder0 l .htm
`
`AMN1028
`
`IPR of US. Patent No. 7,765,163
`Page 13 of 362
`
`AMN1028
`IPR of U.S. Patent No. 7,765,106
`Page 13 of 362
`
`
`
`CDER 2001 Advisory Committee Meeting Documents
`
`1 of9
`
`
`| FDA Home Page "Dockets Home Pave-”t‘Bl-LRI|(‘1)Rll||_(_)g||l_2||;\(‘ \\ hat 5 .\e»| | \eeessibilitvl
`| Federal Registers |
`ll-l-mail | Dockets Management Branch. 5630 Fishers Lane - Room 1061- “FA-305, Rockville. MD. 20852; 301-827-6860; Fax
`301-827—6870
`
`CDER 2001 Meet/n o Documents
`
`
`Ilullu'l'ipl lest H)
`\linnlx-l.
`Ullu-‘r ”01" 11!
` lnIiN'I'Ipl PM 11)
`”up
`“an
`(\i/e ll! kl):
`Milt' m 1.11)
`(we in ltln
`hm- in kln
`
`
`Due to the events ofthis week, this meeting has been postponed. It will be rescheduled Draft Agenda
`in the future. Please check here for the new date.
`3778a1_draft.mlf
`
`
`
`Questions
`3778q1.mfl
`
`Meeting Info
`
`
`m000001.m1_f, ht_m
`
`
`Briefing lnfonnation
`177311] .I'rlrn
`
`Docket NumberOI .\'-0256
`
`
`Mart
`09/12
`
`lmnr—rript leu ll)
`Irunseript l'tvl‘ ll!
`(sm- Il11\1))
`(sim- in km
`Du}
`09/12 Due to the events of this week. this meeting has been postponed.
`here forthe new date.
`
`tJthI'ltm-t H}
`\linnies
`”in: in km
`(xi/t- in kln
`It will be rescheduled in the future. Please check
`
`Pages 1- 100
`3746tl_01.m1[
`(10,540)
`
`3746t1.gf(388) & html
`(392)
`
`Pages 101-200
`3746t1_02.w_f
`(10,646)
`
`
`
`
`.
`,
`'
`
`Pages 201-339
`I3746tl_03.p1f
`I
`(19.170)
`
`4/23
`
`4/23
`
`.3744t1_01.m1_f& ht_m
`
`3744mm
`
`4/24
`
`3744t2.m_r& ht_m
`
`374mm
`
`Agenda
`3746a1.nd_r, h_tn_1
`
`Briefing Info.
`3746bl.ht_m
`
`.
`
`Roster
`3746r1_01committee.ml_.f.
`h_tr_u
`3746r1_02guest.1fl', m
`
`Slides
`374651.ht_m
`
`Notice of Mtg.
`032301d.ht_m & p_d_r
`
`Briefing Information
`3744bl.ht_m
`
`'
`
`Agenda
`37442114flf, ht_m
`
`Roster
`
`3744rl .mfl‘, ht_m
`
`Questions
`3744q1-LMJLLtm
`
`Slides
`
`3744514511~
`Briefing Information
`3744b2.ht_m
`
`http'.//web.archive.org/web/200l 100408 1 740/http:/www.fda.gov/ohrms/dockets.'ac/cder0 l .htrn
`AMN1028
`
`
`IPR of US. Patent No. 7,765,106
`Page 14 of 362
`
`AMN1028
`IPR of U.S. Patent No. 7,765,106
`Page 14 of 362
`
`
`
`CDER 2001 Advisory Committee Meeting Documents
`
`2 Of9
`
`
`
`
`
`Agenda
`3744a2.p<_lf, h_i|fl
`
`Roster
`
`:3744r2-1Llf, him
`
`'Questions
`
`
`l3744q24w. m
`
`
`
`
`37l9tl 01414::6126)
`._ v
`3719mi.§g§.pfl
`3719:: 02‘pgf(6374)
`
`37:9“ 03.9gf(6385)
`'37I9l1 04.mt’(6428)
`
`r .
`3719 I h
`
`tm
`
`
`
`Slides
`37l9s|.htm
`
`Agenda
`371931 ~htm
`
`Question
`3719 Lhtm
`
`I [up
`
`SL111
`
`Du)
`
`II'al'lu lilrr i’lll‘
`hm in LII]
`
`IJ)
`
`Il'mht rim Iq-u Ill
`[xii-r In Min
`
`\lmulu
`{silt In NH
`
`lnl‘u-i lie-n Ill
`{\IJL'
`lli MID
`Draft Agenda 379231 .p(_|f&
`ht_m
`
`Final Agenda 379Zal.utl_f
`
`
`
`& m
`
`Roster
`
`
`Committee 3792rl_01.ui_f
`.& ht_m Consultants &
`
`'Guests 3792r1_02.p1fi
`
`Questions 379ggl 4151f
`
`
`.Briefmg Information
`
`
`'3792bl .htm
`
`Agenda 379232.951! & Mm
`
`
`
`
`Questions 379292.251l‘
`Bn'efing Information
`
`
`2/27
`3731:].nr(271 )
`
`
`(ll.p_(!f(6394)
`:g73lll
`3731i] 02.:flf(6275)
`3731i] 03.flf‘(3920)
`
`
`
`http://web.archive.org/‘web/2001 l0040817401hupzflwww.fda.gov/ohrms/dockets/ac/cderOl.htm
`
`AMN1028
` IPRo .. aent 0., ,
`
`
`Page 15 of362
`
`AMN1028
`IPR of U.S. Patent No. 7,765,106
`Page 15 of 362
`
`
`
`CDER 2001 Advisory Committee Meeting Documents
`
`3 of9
`
`
`.B riefing Information
`
`3731 b1.Lt_t_m_
`
`Questions
`
`
`i3731q1.m. [if
`
`
`1/10
`3676tl a.
`iAgenda
`
`
`'3676tl b.pgf
`|36763L9£vflf
`
`
`
`3676t1 cflf
`'R
`
`
`
`3676“ d.pi:|l
`I oster
`'3676r1.fl,p;1_f
`
`Briefing Information
`
`m
`
`
`3678t1_a.p1f
`
`3578” .11"
`
`“warm, pg;
`
`Briefing Information
`3678b1.ht_m
`
`Slides
`3678s1.m_m
`
`
`I'I'unu‘ripl I’I)l
`ll)
`Irunwnpl int 11)
`
`(xi/c in MM
`(silo in Hip
`
`\linulu
`him in I‘ln
`
`Ullll‘l'l)u1" 11D
`(silr in I‘ln
`
`
`a -£ D—
`
`
`3779t1 .Edf (320)
`
`& M
`
`97g;;d:l h
`Rosters
`Committee
`3779r1_committee.ht_m & ngf
`
`
`
`
`
`Consultants
`
`
`3779r1_consultants.m & p_<l_f
`
`Public Hearing
`3779rl_puhlic_hearing.ht_m & pg!“
`
`
`
`
`
`
`3779a2.m & pg!
`
`Briefing lnfo rmation
`3779111 .mm
`
`
`Questions
`
`r3779ql.hgm & ml!
`
`fRevised Questions
`E3779q1_nevised.ht_m & w
`
`Slides
`
`
`
`3779m2.mlj & m
`
`8/17
`
`Pages 1-100
`:3779t2 0 I .udf
`
`Pages 101-159
`.3779t2 (llpdf
`
`
`Rosters
`Committee
`3779r2_committee.ht_m & pg!
`
`Consultants
`
`3779I’Z_consultants.ht_m & w
`
`
`Public Hearing
`3779rl_public_hearing.ht_m & pg!
`
`http://web.archive.org/web/2001 1004081740/http:/www.fda.gov/ohrms/dockets/ac/cderOl.htm
`
`——
`
`AMN1028
`
`IPR of US. Patent No. 7,753,105
`Page 16 of 362
`
`AMN1028
`IPR of U.S. Patent No. 7,765,106
`Page 16 of 362
`
`
`
`CDER 2001 Advisory Committee Meeting Documents
`
`4of9
`
`Briefing Information
`3779b2.ht_m
`Agenda
`3740al.ht_m & M
`
`Briefing Information
`3740b1.ht_m
`
`Questions
`3740q1.ht_m & 9511
`
`Roster
`
`3740r1_01ht_m & M
`3740r1_02 ht_m & 91f
`
`Slides
`
`m A
`
`genda
`3677a1.(_1_0__c_, mfl'
`
`Roster
`
`3677r1_0| .5193, mfl
`
`Guest Roster
`3677r1_02._d(_)c_, pg"
`
`Briefing Information
`3677b1.h_t_n_1
`
`Questions
`3677q1.<_122.w
`
`
`
`:Briefmg Package
`:3677b2.htm
`
`
`EAgenda
`3677a2.doc & pg"
`
`
`Questions
`
`
`367792 01.doc & pg}:
`
`3677512 02.doc & pd_f
`
`
`Slides
`
`
`3677s2.ht_m
`
`
`
`54/19
`
`4/20
`
`3740t1__01.pfl
`3740tl_02.w
`
`3740t1._r;t_f
`
`3740t1_03.p_d_r
`
`3677t1_01.pfl‘(6421)
`3677tl_02.pif(6733)
`3677t1_03.w (2448)
`
`
`
`W (6774)
`32.6w (6852)
`3677t2 0;.udr (2918)
`
`
`
`
` 3677(2.rtf(597)
`
`| Top ]
`
`lrunwript l’l)l‘ ll)
`(xi/,0 in kh)
`
`Irullw hm lcxl ll!
`Isl/r in Ho!
`
`\Iinulcs
`(xi/r in km
`
`“II1L:1‘IMH"- II)
`um I" Mu
`
`
`
`
`7'75: I .rtf (444)
`
`
`Agenda
`Pages 1-100
`3775“ OLEI'
`37753] .M, pif
`
`Roster
`
`
`Pages 101-200
`3775“ 02.
`1"
`3775r1.htm
`
`Pages 201-300
`
`Briefing Information
`
`377511 03.
`3775bl.htm
`
`Questions
`
`Pages 301-400
`Re mondulin
`
`3775“ 0441".
`
`
`
`3775q1_01.1&f, htm
`
`
`
`'Pages 40141]
`
`
`Extraneal
`9775!] 05m“!
`
`
`
`
`
`f
`
`http;//web.archive.org/web/2001 100408 1 740/http:/www.fda.gov/ohrms/dockets/ac/cderO I .htm
`
`IPRo
`
`.. aen
`
`0
`
`AMN1028
`
`Page 17 of 362
`
`AMN1028
`IPR of U.S. Patent No. 7,765,106
`Page 17 of 362
`
`
`
`CDER 2001 Advisory Committee Meeting Documents
`
`Sof9
`
`:3775q1_02.M, M
`
`Slides
`
`3775sl .lltm
`Briefing Information
`3775b2.htm
`
`Questions
`bosenton
`
`3775q2-1Af. htm
`
`Briefing Information
`3749b1.m
`
`Questions
`3749ql.1&f& ht_m
`Briefing Information
`3749b2.fl_tg|_
`
`Questions
`
`3749q24fl' & ht_m
`
`08/10 Pages 1-100 377St2 Olfljl‘ .1775t2.rtf(299)
`
`3749mm (437)
`
`Pages 101-200
`3775t2 02.
`il‘
`
`Pages 201-228
`
`M 3
`
`749u_01.pd_r(9i7i)
`3749tl_02.pd_f(8690)
`3749t1_03.gfl (7469)
`3749t1_04.2d_f(4025)
`
`37490319176171)
`3749t2_02.w (8465)
`3749t2_03-1Af (8352)
`3749t2_o4.pgf (7345)
`
`3749:2m (465)
`
`floltlmtm
`
`li'HIM‘rIpt PHI 1]?
`min- in Ill".
`In!)
`07/26 Pages 1-100
`376ltl 0|.pdf(9,446)
`
`
`
`Pages 101-200
`
`:376l tl 02.:§lf(9,613)
`
`Iran“ up! 11'“ ll?
`hill‘ in I‘M
`
`Pages 201—300
`3761 (I 03.3“ (9,586)
`
`lpages 301—342
`376m 04.9-5If(8,306)
`
`\linutcs
`(xi/.0 in km
`
`3761m1.p(_lf & m
`
`Ulltcl' lhus ll!
`Isl/x in Lli)
`
`'Notice of Meeting
`June 8, 200l L_\t 1w
`
`Agenda
`376121.pd_f. ht
`
`Questions
`
`I
`g3761q14m, htm
`
`Briefing Information
`3761M.”
`
`Slides
`
`07/27 PagesI-IOO
`376lt2 01. df(8,398)
`
`_— __—1—
`3_761t2.htm
`:3761m2.p(_lf & m
`
`Pages 101-200
`376lt2 02. "(8,508)
`
`Pages 201-300
`376lt2 03.1.f(8.318)
`
`Pages 301-359
`376lt2 044 {(9,991)
`
`Agenda
`3761a24m, ht
`
`3
`
`Questions
`3761q2Jfl3 ht
`
`S
`
`Roster
`
`
`3761r2.pd_f. htm
`
`Briefing Information
`3761 b2.hu_n
`
`Slides
`M
`
`i
`
`I
`
`!
`
`10)
`
`Hill." in Isl!) (\Itk' in MM
`
`\Ill‘llllC\
`ml;- in kh)
`
`Utllw Ilium I"
`(“It In I‘lu
`
`'I’Iunu IIIOl l’lll'
`
`ll)
`
`lmnu up! lL‘kl ll!
`
`http://web.archi ve.org/web/2001 100408 1 740/th:/www.fda.gov/ohrms/dockets/ac/cdero1 .htm
`
`—
`
`AMN1028
`
`IPR ofU.S. Patent No. 7, 733, I05
`Page 18 of 362
`
`AMN1028
`IPR of U.S. Patent No. 7,765,106
`Page 18 of 362
`
`
`
`CDER 2001 Advisory Committee Meeting Documents
`
`60f9
`
`
`
`Pages 101-200
`3737tl 02. I
`1 f
`
`
` Pages 1-100
`373mm
`3737tl 0| .mf
`
` Pages 201-300
`l'
`3737t1 03.:
` Pages 301-345
`3737 1 04 .. r
`
`
`
`:3737m1.pfl, mull
`
`Agenda
`3737a] .ht_m, pd_f
`
`Planning Agenda
`3737a1__planning.ht_m, 2g“
`
`Questions
`373791-1191, 12th
`
`lBriefing Information
`13737hl .htm
`
`:Petition
`
`
`
`IruuM' 11"! 11'“ H)
`{am Ill kl‘n
`
`\liuuuw
`lsllr in MN
`
`Stun
`09/10
`
`II)
`
`Il'nllM I'ipt I’IJI
`mm in km
`Du}
`09/10 Moming Session Pages
`1-100 3782tl Ulaqfif
`(10,008) Pages 101-179
`37821] 01b. df
`
`Afternoon Session Pages
`1-100 378211 02a.|fif
`(9,796) Pages 101-200
`3782t1 02b.;1df(9,878)
`Pages 201-225
`378211 02c.pfif (2,226)
`
`(’llll‘l Uln's Ill
`hi.“ in Ho}
`
`'Agenda
`.3782al.pif & ht_m
`IRev'sed Agenda
`l3782al_mvised.p1f & htm
`:Roster
`'3782r1.pif & m
`Consultants
`
`3782rl_eonsultants.& &
`ILL-11
`lQuestions
`I3782q1.1gf& h_tm
`Ilntradose 3782ql_02. pg!
`l& ELI!
`
`Briefing Information
`3782bl.!]tm
`
`Slides 378Zsl.gtm
`Briefing Information
`31%
`
`Questions
`3782q2_zevalin.pif & ht_m
`
`Slides 3782s2.htm
`
`Agenda
`3756al.ht_m, pfl
`
`Roster
`3756rl.mm, pfl‘
`
`Briefing Infomation ht_m &
`
`3782t2.htm
`
`09/11
`
`Pages 1-100
`3782t2 01.31“ Pages
`101-200 3782t2 02.pi_:lf
`Pages 201-239
`3782t2 0343f
`
`06/28
`
`06/28 Pages 1-100
`3756” ”Ll!”
`
`3756t1.gf, 37S6t1.m
`
`Pages 101-200
`3756!] 0243“
`
`Pages 201-end
`3756t1 03.
`ll‘
`
`Pages 101-201
`g3757tl 024511
`
`htm
`
`http://web.archive.org,/'web/2001 100408 l740/http:lwww.fda.gov/ohrms/dockets/ac/cdero1.htm
`
`AMN1028
`
`I
`
`PRofU.S.
`atent
`o.
`,
`,
`Page 19 of 362
`
`AMN1028
`IPR of U.S. Patent No. 7,765,106
`Page 19 of 362
`
`
`
`CDER 2001 Advisory Committee Meeting Documents
`
`7 of9
`
`4/24
`
`4/24
`
`'3743n_01.pd_i
`3743t1_02.w
`|3743tl_03.pgf
`I
`
`'l'op
`
`'
`
`3743mm
`
`'
`
`.
`
`Agenda
`3743a1.ht_m & 1m
`
`
`
`
`
`Slides
`
`
`3743sl.ht_m
`
`Roster
`3743 r1.mm, pfl
`
`Briefing Information
`3743b1.ht_m & pg
`
`
`
`Ulliu Dun Ill
`\lmulcs
`lrmlu'npl In! 11)
`Iramsrripl J'DI
`Hmrl:
`Du)
`hue in 1.1;)
`Isl/c in I‘ln
`(\i/r in km
`min- in Lln
`
`
`6/6
`6/6
`Pages 1-100
`3754tl .txt
`|3754m1.1_)d_f, html
`Agenda
`3754t1_01.pfl
`3754a14m html
`
`I}!
`
`'
`
`Pages 101-200
`-3754t1_02.M
`'
`
`Pages 201-300
`37S4t1_03.1m‘
`
`Pages 301-381
`3754tl_04.pfl
`
`I
`
`Rosters
`Members 3754r1_01.pd_1;
`html
`
`Consultants
`3754rl_02.pd_f. ht_ml
`
`Public Hearing
`3754rl_03.p(_|f, ht_ml
`
`Questions
`3754q1.1flf. html
`
`iBriefing Information
`|3754b1.ht_m
`
`Slides
`375451.m
`
`3/13
`
`[3724:].2gj
`
`._
`
`3724m1.m
`3742mm;
`
`372mm
`
`3724m2¢m
`3724mm;
`
`
`
`_
`
`mung, my
`
`Roster
`
`3724r1_01.M. ufl
`
`Briefing Info
`3724b1.ht_m
`
`Slides
`
`3724s1.ht_m
`Agenda (DRAFT)
`3724a2.glLe, Lug
`
`Roster
`
`3724r1_02.M, &'
`
`Briefing Info
`3724b2.m
`
`ISlides
`'3724s2.m
`
`10)
`
`Ulllu Duh II'J
`\Iimlle‘
`Il'illlu‘l‘llll Ir\l ll)
`Irufiwrflfl I’I'Jl
`(sin- in km
`MIT in MI)
`iii/‘3 in HM
`um- in km
`1121)
`Slim
`
`
`
`
`3763tl.htm,t.'t07/19 Pagesl-10007/19 3763m1.ht_m& Agenda
`
`ll')
`
`http://web.archive.org/web/2001 1004081740/http:/'www.fda.gov/ohrms/dockets/ac/cderO1.htm
`AMN1028
`
`IPR of US. Patent No. 7,765,106
`Page 20 of 362
`
`AMN1028
`IPR of U.S. Patent No. 7,765,106
`Page 20 of 362
`
`
`
`CDER 2001 Advisory Committee Meeting Documents
`
`8 of 9
`
`pg!
`
`3763a1.ht_ln&w_f
`
`Roster
`3763rl.ht_m&;fif
`Guest Roster
`
`3763rl_guest.m &
`1!!!
`FDA Roster
`3763r1_fda.§l_o_c; &
`p511.
`
`Questions
`3763q2.Ltm & w!
`
`Briefing
`Information
`3763bl.ht_m
`
`Slides
`376351.359
`3763m2.ht_m & Agenda
`1231f
`3763a2.ht_m & 1Q”
`
`Guest Roster
`
`3763r2_guest.d£ &
`
`@F
`
`DA Roster
`3763r2_fda.@£ &
`
`& S
`
`lides
`376382.ht_m
`
`76 tl 0l..-l"
`
`Pages 101-200
`76 tl
`l2.-f
`
`Pages 201-300
`3763tl 03..
`f
`
`Pages 301-313
`3763tl 04.
`l‘
`
` 7/20 Pages 1-100
`
`37 SO 0l.
`
`Pages 101-171
`
`7/17
`
`7/17
`
`
`
`
`9801032301 “M"
`
`Information
`3764b1.ht_m
`
`Slides
`3764s1.m
`
`fi742fi.mif
`(10,036)
`
`3742tl._r_t_f(93)&
`html (100)
`
`3742rl.ht_m & M
`
`
`3742r2._lnm & w
`
`
`
`Briefing Info
`
`3742hl.ht_m & fl
`
`
`Notice of Meeting
`
`
`98 01032301 g.hi_m
`
`
`
`http://web.archive.org/web/20011004081740/http:/www.fda.gov/ohrms/dockets/ac/cdero1.htm
`AMN1028
`
`IPR of US. Patent No. 7,765,106
`Page 21 of 362
`
`AMN1028
`IPR of U.S. Patent No. 7,765,106
`Page 21 of 362
`
`
`
`CDER 2001 Advisory Committee Meeting Documents
`
`9 of9
`
`
`ltuihuipl I’IH‘
`ll!
`Inum nil-l In: I"
`\Iinutcs
`{Jun-i llm. ~. ll]
`
`
`
`
`(\i/c in Mt) [51/5,- in My)nin‘ in IJH hi1: ill Mn
`
`
`.._
`3685m14fl
`Agenda
` 3685tl.ml_f
`
`368521.fl, p_d_f
`
` Roster
`
`368511 .M, p_d_f
`
` Questions
`
`“Sill-M. ml!
`
`Briefing Info
`
` 3685bl.m
`
`Slides
`
`
`
`53685$Lht_m
`
`n
`
`
`3685t2.p_d_f
`.3685t2.
`\(
`3685m2.gfl'
`_Agenda
`j3685a2.d(_)c, p(_]_f
`
`
`|Roster
`
`
`E3685r2.fl, pd_f
`
`
`'Questions
`.3685q2m. [fl
`
`
`Briefing Info
`
`3685b2.ht_m
`
` Slides
`
`3685s2.ht_m
`
`Ii-nnui-im Pl'vl' ll'!
`!\l/l‘ in km
`
`[mun-nip: I'ru JD
`{sin in MM
`
`Slim-1m
`(xi/r in Mt)
`
`[Ml'wr Dun. II'I
`{sim- in Id);
`
`:Pctition
`
`3737t1.fl
`
`3737ml.p1f, html
`
`Pages 1-100
`3737:] 0L[n_.1f
`
`Pages 101-200
`
`Pages 201-300
`3737a 03.[n_JI'
`
`Pages 301-345
`3737t1 04.[n_.tf
`
`Agenda
`I
`I3737al.m,1&f
`
`Planning Agenda
`3737al__pla nningm. pgf
`
`|Questions
`I3737ql.m, g
`|
`
`IBriefing Information
`f3737l)l.htm
`
`'lo )
`
`(Updated 10/0210: )
`
`http:/iweb.archive.org/web/200 1 100408 l740/http2/www.fda.gov/'ohrms/dockets/ac/cderO1.htm
`AMN1028
`
`
`
`IPR of US. Patent No. 7,765,106
`Page 22 of 362
`
`AMN1028
`IPR of U.S. Patent No. 7,765,106
`Page 22 of 362
`
`
`
`CDER 2001 Advisory Committee Meeting Documents
`
`lofll
`
`
`] Federal Registers] ] FDA Home Pa re "Dockets Home PEECIICBERHCDRHIIQJILE” \(7 What's Vow] [Aceessibilitvl
`[Ii-mail [ Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-JOS. Roekville, MD, 20852; 301-827-6860: Fax
`301-827-6870
`
`CDER 2001 Meet/n a Documents
`Anesthetic and Life Sumort Drug-r Advisorv ( 'omnm
`Anti-lnfective Drugs Adviso rv Committee
`Anti-Viral Drugs Adviso [3‘ Committee
`Arthritis Advisorv Committee
`(‘ardimascularand Renal Drugs Advisorv Committee
`Endocrinologic and Metabolic Drugs Advisorv Committee
`Nongrescn'ption Drugs Advisorv Committee
`OncoIOg-ic Drugs Advisorv Committee
`Pen' heral and Central Nervous Svstem Dru s Advisorv Committee
`
`Adviso rv (‘ommittee for Pharmaceutical Science
`
`Psvchophamracologic Drugs «\dvisorv Committee
`Pulmonarv—Mle _'_\ Druls Advison Committee
`
`lrrrl'm-i'rpt 'I'eu ll)
`lrrrnwript 1'1” 1”
`{slit in M0)
`(3111' in km
`Due to the events of this week, this meeting has been postponed.
`in the future. Please check here forthe new date.
`
`(hilt-r0111“. 11')
`\linutcs
`\‘iljf in kl)!
`(xi/.0 ill Mi)
`It will be rescheduled Draft Agenda
`3778a1_d1~aft.mf
`
`
`
`Questions
`3778ql .p(_lf
`
`Meeting Info
`m000001.w, ht_m
`
`Briefing Information
`3778b1.htm
`
`Docket Number 01 N-0256
`
`'1’1'21nscr'iptl’l)l
`(size in Ixh)
`
`ll)
`
`Il';111\(|'l|11 lcxr ll)
`txizc in H1)
`
`\linulcs
`[~111-
`rr'r Mn
`
`()tircr Docs II)
`(Si/1‘ in Mn
`
`11/07
`
`11/07
`
`I
`
`10/16
`
`10/16 IPagesl-IOO
`3797a 014m
`
`3797r1.[\\'on1vmion1(477)
`&]llT\Ili\’ersion](394)
`
`Pages 101-200
`3797t1 02.;qu
`
`:Pages 201-300
`l3797t1 03.11;.”
`
`Final Agenda [Word
`version] [Qdfversion] [htm
`version]
`
`
`Draft Agenda [Word
`version] [Elf version] [ht_m
`version]
`
`Questions [Word version]
`[E!f\ ersion] [htm version]
`Briefing Information m
`Agenda htm & fld_f
`
`Questions my; & pd_f
`
`Briefinglnformation
`
`iRoster
`Committee Members hr—
`& 2d_f
`
`Pages 301-345
`ISIides 3797s] .htm
`379m 04.9.10
`09/12 Due to the events ofthis week, this meeting has been postponed. It will be rescheduled in the future. Please check
`here for the new date. This meeting was rescheduled for 10/16/01.
`
`i
`
`_
`
`09/12
`
`http://w eb.archive.org/web/2001 l 1161444l9/http:/www.fda.gov/ohrms/do