`Schweikert et a].
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 8,257,325 B2
`Sep. 4, 2012
`
`US008257325B2
`
`(54) VENOUS ACCESS PORT WITH MOLDED
`AND/OR RADIOPAQUE INDICIA
`
`(75) Inventors: Timothy M. SchWeikert, LevittoWn, PA
`(US); Raymond R. Bizup, Feasterville,
`PA (US); Kevin E. Sanford, Chalfont,
`PA (US); Kenneth M. Zinn, Westport,
`CT (Us)
`
`DE
`
`(73) Assignees: Medical Components, Inc.,
`Harleysville, PA (US); Innovative
`Medical Devices, LLC, Westport, CT
`(Us)
`
`( * ) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 294 days.
`
`(21) Appl- N05 12/143,377
`
`(22) Filed:
`
`Jun. 20, 2008
`
`(65)
`
`Prior Publication Data
`Us Zoos/0319399 A1
`Dec‘ 25’ 2008
`
`Related U.S. Application Data
`
`8/1910 Merrill
`966,696 A
`5/1929 Crowley
`1,713,267 A
`2/1936 Bartschl et al.
`2,029,553 A
`2’433’480 A 12/1947 _Rendlch
`(Connnued)
`
`FOREIGN PATENT DOCUMENTS
`84 37 873 U1
`2/1986
`(Continued)
`
`OTHER PUBLICATIONS
`
`BARD Access System product drawings representative of the BARD
`Access System products on the market on or around Mar. 1995 as
`indicated by the BARD Access Systems Mar. 21, 1995 Product
`Release to Market form for “M.R.I. Port With 8 Fr. ChronoFleX®
`Catheter,” “M.R.I. Port with 8 Fr. ChronoFleX Catheter with Intro
`EZeTM,” “M.R.I. Port with 8 Fr. Chrono-Flex Catheter and Peel
`Apart,” “M.R.I. Port With 8 Fr. ChronoFleX Catheter Demo Kit,” 6
`
`pages‘
`
`(Continued)
`
`Primary Examiner * Kevin C Sirmons
`Assistant Examiner * Bradley Thomas, Jr.
`(74) Attorney, Agent, or Firm * Blank Rome LLP
`
`(60) ggogisgomal application No. 60/936,491, ?led on Jun.
`
`(57)
`
`ABSTRACT
`
`’
`(51) Int. Cl.
`(2006.01)
`A61M 37/00
`(2006-01)
`A61K 9/22
`(52) U.S. Cl. ......... .. 604/288.01; 604/891.1; 604/288.02;
`604/28804
`(58) Field of Classi?cation Search ............. .. 604/891 .1,
`60408801, 28802, 536, 175
`See application ?le for complete search history,
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`574,387 A
`1/1897 Buckler
`611,357 A
`9/1898 Dembinski
`
`A venous access port assembly having a housing base With a
`discharge port, a septum and a cap. An interior reservoir is
`de?ned by a Well in the housing base and a bottom of the
`septum, and a passageway extends from the reservoir through
`the discharge port. The housing base includes a base ?ange
`having integrally molded therein indicia identifying an
`attribute of the assembly. The indicia could be formed of base
`?ange material, or could be formed by voids in the base ?ange
`material. If of plastic material, the molded indicia could be
`applied With a radiopaque agent, thereby alloWing the indicia
`(“CT”) to appear on an X-ray of the patient in a manner
`informing a practitioner of a particular attribute of the assem
`bly.
`
`22 Claims, 5 Drawing Sheets
`
`Bard Exhibit 1001 Page 1 of 17
`
`
`
`US. PATENT DOCUMENTS
`6/1959
`Gould
`2,891,689
`6/1964
`Weichselbaum
`D198,453
`12/1966
`Cronin
`3,293,663
`9/1967
`Sinaiko
`3,341,417
`Ring
`6/1970
`3,518,428
`9/1970
`Vaillancourt
`3,529,633
`2/1972
`Morderosian
`3,643,358
`Ling et al.
`8/1974
`3,829,904
`8/1974
`3,831,583
`Edmunds, Jr. et al.
`10/1974
`3,840,009
`Michaels et al.
`7/1975
`Herbert
`3,891,997
`10/1975
`Miller
`3,915,162
`11/1975
`3,919,724
`Sanders et al.
`12/1975
`3,922,726
`Trentani et al.
`4/1976
`3,951,147
`Tucker et al.
`6/1977
`Samis
`4,027,391
`7/1977
`Karasko
`4,035,653
`10/1978
`4,121,108
`Manor
`11/1978
`4,123,806
`AmstutZ et al.
`9/1979
`Samis
`4,168,586
`2/1980
`Schulte
`4,190,040
`2/1980
`4,190,057
`Hill et al.
`3/1980
`4,194,122
`Mitchell et al.
`5/1980
`4,202,349
`Jones
`Sampson et al.
`9/1980
`4,222,374
`11/1980
`4,233,964
`Jefferts et al.
`6/1981
`Caine
`4,274,006
`9/1982
`4,349,498
`Ellis et al.
`11/1982
`4,361,153
`Slocum et al.
`Stephen et al.
`9/1983
`4,405,305
`9/1983
`Samis
`4,406,567
`Berglund
`1/1984
`4,425,119
`5/1984
`Gianturco
`4,445,896
`5/1984
`4,450,592
`Niederer et al.
`5/1984
`Beard
`4,450,985
`6/1984
`4,456,011
`Warnecke et al.
`9/1984
`4,469,483
`Becker et al.
`1/1985
`4,494,545
`Slocum et al.
`3/1985
`Duska
`4,506,676
`7/1985
`Sheldon
`4,529,635
`9/1985
`4,543,088
`Bootrnan et al.
`Groshong et al.
`10/1985
`4,549,879
`Groshong et al.
`12/1985
`4,559,046
`2/1986
`Fischell
`4,571,749
`3/1986
`4,576,595
`Aas et al.
`5/1986
`Haber
`4,587,954
`Hayes et al.
`9/1986
`4,612,877
`12/1986
`Schmitt
`4,627,844
`1/1987
`4,634,427
`Hannula et al.
`1/1987
`4,636,194
`Schulte et al.
`1/1987
`Pakiam
`4,636,213
`2/1987
`Vaillancourt
`4,645,495
`3/1987
`4,653,508
`Cosman
`4/1987
`Swift
`4,655,765
`Coneys
`4/1987
`4,657,024
`Hargis
`5/1987
`4,662,652
`5/1987
`Luther
`4,668,221
`Groshong et al.
`6/1987
`4,671,796
`6/1987
`4,673,394
`Fenton, Jr. et al.
`8/1987
`Reinicke
`4,684,365
`8/1987
`4,685,447
`Iversen et al.
`8/1987
`4,685,905
`Jeanneret nee Aab
`Hilger
`9/1987
`4,692,146
`9/1987
`4,695,273
`Brown
`Breyer et al.
`10/1987
`4,697,595
`Groshong et al.
`10/1987
`4,701,166
`11/1987
`4,704,103
`Stober et al.
`12/1987
`4,710,174
`Moden et al.
`1/1988
`LaZorthes
`4,718,894
`3/1988
`4,728,894
`Yoda et al.
`Kay et al.
`5/1988
`4,743,231
`6/1988
`4,753,640
`Nichols et al.
`Konopka et al.
`7/1988
`4,755,173
`8/1988
`Petit
`4,760,837
`McIntyre et al.
`8/1988
`4,762,517
`8/1988
`4,767,410
`Moden et al.
`9/1988
`4,772,270
`Wiita et al.
`9/1988
`4,772,276
`Wiita et al.
`
`US 8,257,325 B2
`Page 2
`
`4,773,552
`4,778,452
`4,781,680
`4,781,685
`4,781,695
`4,802,885
`4,804,054
`4,820,273
`4,822,341
`4,840,615
`4,848,346
`4,857,053
`4,861,341
`4,863,470
`4,886,501
`4,892,518
`4,904,241
`4,905,709
`4,909,250
`4,915,690
`4,928,298
`4,929,236
`4,955,861
`4,963,133
`4,966,583
`4,973,319
`4,983,162
`5,009,644
`5,013,298
`5,041,098
`5,044,955
`5,045,060
`5,045,064
`5,084,015
`5,085,216
`5,090,066
`5,092,849
`5,108,317
`5,108,377
`5,112,301
`5,112,303
`5,129,891
`5,137,529
`5,147,483
`5,152,753
`5,156,600
`5,158,547
`5,167,629
`5,167,633
`5,167,638
`5,171,228
`5,176,653
`5,176,662
`5,178,612
`5,185,003
`5,189,690
`5,193,106
`5,195,122
`5,195,123
`5,201,715
`5,203,771
`5,203,777
`5,213,574
`5,215,537
`5,222,499
`D337,637
`5,224,938
`5,263,930
`5,281,205
`5,290,263
`5,295,658
`5,299,253
`5,309,863
`5,312,337
`5,318,545
`5,320,100
`5,328,480
`5,332,398
`5,334,153
`
`9/1988
`10/1988
`11/1988
`11/1988
`11/1988
`2/1989
`2/1989
`4/1989
`4/1989
`6/1989
`7/1989
`8/1989
`8/1989
`9/1989
`12/1989
`1/1990
`2/1990
`3/1990
`3/1990
`4/1990
`5/1990
`5/1990
`9/1990
`10/1990
`10/1990
`11/1990
`1/1991
`4/1991
`5/1991
`8/1991
`9/1991
`9/1991
`9/1991
`1/1992
`2/1992
`2/1992
`3/1992
`4/1992
`4/1992
`5/1992
`5/1992
`7/1992
`8/1992
`9/1992
`10/1992
`10/1992
`10/1992
`12/1992
`12/1992
`12/1992
`12/1992
`1/1993
`1/1993
`1/1993
`2/1993
`2/1993
`3/1993
`3/1993
`3/1993
`4/1993
`4/1993
`4/1993
`5/1993
`6/1993
`6/1993
`7/1993
`7/1993
`11/1993
`1/1994
`3/1994
`3/1994
`3/1994
`5/1994
`5/1994
`6/1994
`6/1994
`7/1994
`7/1994
`8/1994
`
`Boege et al.
`Moden et al.
`Redmond et al.
`Lehmann et al.
`Dalton
`Weeks et al.
`Howson et al.
`Reinicke
`Colone
`Hancock et al.
`Crawford
`Dalton
`Woodburn
`Carter
`Johnston et al.
`Cupp et al.
`Bark
`Bieganski et al.
`Smith
`Cone et al.
`Tanaka et al.
`Sampson
`Enegren et al.
`Whipple
`Debbas
`Melsky
`Metais et al.
`McDonald
`Moden et al.
`Loiterman et al.
`Jagmin
`Melsky et al.
`Idriss
`Moriuchi
`Henley, Jr. et al.
`Schoepe et al.
`Sampson
`Beinhaur et al.
`Cone et al.
`Fenton, Jr. et al.
`PudenZ et al.
`Young
`Watson et al.
`Melsky et al.
`Laguette et al.
`Young
`Doan et al.
`Vertenstein et al.
`Mann et al.
`Felix et al.
`McDonald
`Metals et al.
`Bartholomew et al.
`Fenton, Jr.
`Brethauer
`Samuel
`DeSena
`Fabian
`Clement
`Masters
`Melker et al.
`Lee
`Tucker
`Lynn et al.
`Allen et al.
`Tucker
`Fenton, Jr.
`Ensminger
`McPherson
`Wigness et al.
`Atkinson et al.
`Wessels
`Leeb, Jr.
`Flaherty et al.
`Tucker
`Herweck et al.
`Melker et al.
`Miller et al.
`McIntyre et al.
`
`Bard Exhibit 1001 Page 2 of 17
`
`
`
`US 8,257,325 B2
`Page 3
`
`5,336,194
`5,338,398
`5,350,360
`5,352,204
`5,360,407
`5,383,233
`5,383,858
`D355,240
`5,387,192
`5,394,457
`5,395,324
`5,397,329
`5,399,168
`5,405,402
`5,417,565
`5,417,656
`5,421,814
`5,423,334
`5,425,762
`5,433,480
`5,456,698
`5,476,460
`5,476,880
`5,484,402
`5,503,630
`5,507,813
`5,509,805
`5,513,637
`5,514,103
`5,520,632
`5,527,277
`5,527,307
`5,531,684
`5,556,381
`5,558,641
`5,562,617
`5,562,618
`5,575,770
`5,607,393
`5,607,407
`5,613,945
`5,620,419
`5,632,729
`5,637,102
`5,638,832
`5,647,855
`5,662,612
`5,676,146
`5,695,490
`5,702,128
`5,702,363
`5,704,915
`5,709,668
`5,713,844
`5,713,858
`5,713,859
`5,718,382
`5,718,682
`5,725,507
`5,733,336
`5,733,400
`5,741,228
`5,743,873
`5,743,891
`5,746,460
`5,758,667
`5,769,823
`5,773,552
`5,776,188
`5,792,104
`5,792,116
`5,810,789
`5,824,071
`5,830,172
`5,833,654
`5,835,563
`5,836,935
`5,840,063
`5,843,069
`
`8/1994
`8/1994
`9/1994
`10/1994
`11/1994
`1/1995
`1/1995
`2/1995
`2/1995
`2/1995
`3/1995
`3/1995
`3/1995
`4/1995
`5/1995
`5/1995
`6/1995
`6/1995
`6/1995
`7/1995
`10/1995
`12/1995
`12/1995
`1/1996
`4/1996
`4/1996
`4/1996
`5/1996
`5/1996
`5/1996
`6/1996
`6/1996
`7/1996
`9/1996
`9/1996
`10/1996
`10/1996
`11/1996
`3/1997
`3/1997
`3/1997
`4/1997
`5/1997
`6/1997
`6/1997
`7/1997
`9/1997
`10/1997
`12/1997
`12/1997
`12/1997
`1/1998
`1/1998
`2/1998
`2/1998
`2/1998
`2/1998
`2/1998
`3/1998
`3/1998
`3/1998
`4/1998
`4/1998
`4/1998
`5/1998
`6/1998
`6/1998
`6/1998
`7/1998
`8/1998
`8/1998
`9/1998
`10/1998
`11/1998
`11/1998
`11/1998
`11/1998
`11/1998
`12/1998
`
`Polaschegg et al.
`SZwejkowski et al.
`Ensminger et al.
`Ensminger
`Leonard
`Russell
`Reilly et al.
`Gladfelter et al.
`GlantZ et al.
`Leibinger et al.
`Hinrichs et al.
`Allen
`Wadsworth, Jr. et al.
`Dye et al.
`Long
`Ensminger et al.
`Geary
`Jordan
`Muller
`Gresham et al.
`Byland et al.
`Montalvo
`Cooke et al.
`Saravia et al.
`Ensminger et al.
`Dowd et al.
`Jagrnin
`Twiss et al.
`Srisathapat et al.
`Leveen et al.
`Ensminger et al.
`Srisathapat et al.
`Ensminger et al.
`Ensminger et al.
`GlantZ et al.
`Finch, Jr. et al.
`Cai et al.
`Melsky et al.
`Ensminger et al.
`Tolkoff et al.
`Cai et al.
`Lui et al.
`Cai et al.
`Tolkoff et al.
`Singer et al.
`Trooskin
`Niehoff
`Scarborough
`Flaherty et al.
`Maxim et al.
`Flaherty
`Melsky et al.
`Wacks
`Peyrnan
`Heruth et al.
`Finch, Jr. et al.
`Jaeger
`Tucker
`Petrick
`Neuenfeldt et al.
`Gore et al.
`Lambrecht et al.
`Cai et al.
`Tolkoff et al.
`Marohl et al.
`Slettenmark
`Otto
`Hutchings et al.
`Shepherd et al.
`Speckman et al.
`Berg et al.
`Powers et al.
`Nelson et al.
`Leveen et al.
`Powers et al.
`Navab et al.
`Ashton et al.
`Flaherty
`Butler et al.
`
`5,853,394
`5,868,702
`5,882,353
`5,895,424
`5,906,596
`5,908,414
`5,913,998
`5,916,263
`5,925,017
`5,925,030
`5,928,197
`5,931,829
`5,935,084
`5,944,023
`5,944,688
`5,944,712
`5,947,953
`5,951,512
`5,951,522
`5,954,687
`5,957,890
`5,968,011
`5,970,162
`5,989,216
`5,989,239
`5,997,524
`6,007,516
`6,013,051
`6,013,058
`6,017,331
`6,022,335
`6,033,389
`6,039,712
`6,077,756
`6,086,555
`6,090,066
`6,102,884
`6,113,572
`6,120,492
`6,161,033
`6,171,198
`6,171,298
`6,174,330
`6,190,352
`6,193,684
`6,198,807
`6,203,570
`6,213,973
`6,228,088
`6,251,059
`D445,175
`6,269,148
`6,287,293
`6,290,677
`6,302,875
`6,305,413
`D450,115
`6,332,874
`6,347,241
`6,355,021
`6,356,782
`6,361,557
`6,398,764
`6,419,680
`6,450,937
`6,478,783
`6,482,217
`6,494,867
`6,497,062
`6,500,155
`6,503,228
`6,527,754
`6,537,255
`RE38,074
`6,582,418
`6,613,002
`6,613,662
`6,626,936
`6,629,950
`
`A
`
`12/1998
`2/1999
`3/1999
`4/1999
`5/1999
`6/1999
`6/1999
`6/1999
`7/1999
`7/1999
`7/1999
`8/1999
`8/1999
`8/1999
`8/1999
`8/1999
`9/1999
`9/1999
`9/1999
`9/1999
`9/1999
`10/1999
`10/1999
`11/1999
`11/1999
`12/1999
`12/1999
`1/2000
`1/2000
`1/2000
`2/2000
`3/2000
`3/2000
`6/2000
`7/2000
`7/2000
`8/2000
`9/2000
`9/2000
`12/2000
`1/2001
`1/2001
`1/2001
`2/2001
`2/2001
`3/2001
`3/2001
`4/2001
`5/2001
`6/2001
`7/2001
`7/2001
`9/2001
`9/2001
`10/2001
`10/2001
`11/2001
`12/2001
`2/2002
`3/2002
`3/2002
`3/2002
`6/2002
`7/2002
`9/2002
`11/2002
`11/2002
`12/2002
`12/2002
`12/2002
`1/2003
`3/2003
`3/2003
`4/2003
`6/2003
`9/2003
`9/2003
`9/2003
`10/2003
`
`Tolkoff et al.
`Stevens et al.
`VanBeek et al.
`Steele, Sr. et al.
`Tallarida
`Otto et al.
`Butler et al.
`Goicoechea et al.
`Kriesel et al.
`Gross et al.
`Niehoff
`Burbank et al.
`Southworth
`Johnson et al.
`Lois
`Frassica et al.
`Ash et al.
`Dalton
`Rosato et al.
`Baudino
`Mann et al.
`Larsen et al.
`Kawashima
`Johnson et al.
`Finch et al.
`Burbank et al.
`Burbank et al.
`Nelson
`Prosl et al.
`Watts et al.
`Ramadan
`Cornish
`Fogarty et al.
`Lin et al.
`Eliasen
`Schnell
`Squitieri
`Gailey et al.
`Finch et al.
`Kuhn
`LiZama Troncoso et al.
`Matsuura et al.
`Stinson
`Haarala et al.
`Burbank et al.
`DeSena
`Baeke
`Eliasen et al.
`Miller et al.
`Apple et al.
`Bertheas
`Jessop et al.
`Jones et al. .............. .. 604/891.1
`Arai et al.
`Makower et al.
`Fischer et al.
`Bertheas
`Eliasen et al.
`Burbank et al.
`Nielsen et al.
`Sirimanne et al.
`Gittings et al.
`Finch, Jr. et al.
`Cosman et al.
`Mercereau et al.
`Moorehead
`Pintor et al.
`Elver et al.
`Koopman et al.
`Sasso
`Li et al.
`Tallarida et al.
`Raines
`Recinella et al.
`Verbeek et al.
`Clark et al.
`Wark et al.
`Stinson
`Levin
`
`Bard Exhibit 1001 Page 3 of 17
`
`
`
`6,632,217 B2 10/2003 Harper et al.
`6,652,486 B2 11/2003 Bialecki et al.
`6,652,503 B1
`11/2003 Bradley
`6,676,633 B2
`1/2004 Smith et al.
`6,697,664 B2
`2/2004 KienZle, III et al.
`6,705,316 B2
`3/2004 Blythe et al.
`6,719,721 B1
`4/2004 OkaZaki et al.
`6,719,739 B2
`4/2004 Verbeek et al.
`6,738,531 B1
`5/2004 Funahashi
`6,755,842 B2
`6/2004 Kanner et al.
`6,758,841 B2
`7/2004 Haarala et al.
`6,767,356 B2
`7/2004 Kanner et al.
`6,784,783 B2
`8/2004 Scoggin et al.
`6,826,257 B2 11/2004 Sayre et al.
`6,852,106 B2
`2/2005 Watson et al.
`6,878,136 B2
`4/2005 Fleury et al.
`6,878,137 B2
`4/2005 Benchetrit
`6,949,084 B2
`9/2005 Marggi et al.
`6,962,580 B2 11/2005 Adams et al.
`6,994,315 B2
`2/2006 Ryan et al.
`6,997,914 B2
`2/2006 Smith et al.
`7,008,377 B2
`3/2006 Beane et al.
`7,008,412 B2
`3/2006 Maginot
`7,016,456 B2
`3/2006 Basu et al.
`7,018,361 B2
`3/2006 Gillespie, Jr. et al.
`7,044,942 B2
`5/2006 Jolly et al.
`7,056,316 B1
`6/2006 Burbank et al.
`7,070,591 B2
`7/2006 Adams et al.
`7,072,704 B2
`7/2006 BucholZ
`7,074,232 B2
`7/2006 Kanner et al.
`7,083,593 B2
`8/2006 StultZ
`7,108,686 B2
`9/2006 Burke et al.
`7,123,690 B1
`10/2006 Brown et al.
`7,127,040 B2 10/2006 Sayre et al.
`7,131,962 B1
`11/2006 Estabrook et al.
`7,140,769 B2 11/2006 Kay
`7,191,011 B2
`3/2007 Cantlon
`7,198,631 B2
`4/2007 Kanner et al.
`7,214,207 B2
`5/2007 Lynch et al.
`7,214,215 B2
`5/2007 Heinzerling et al.
`7,223,257 B2
`5/2007 Shubayev et al.
`7,229,417 B2
`6/2007 Foerster et al.
`7,235,067 B2
`6/2007 Morris et al.
`D546,440 S
`7/2007 Burnside
`7,242,982 B2
`7/2007 Singhal et al.
`7,252,469 B2
`8/2007 ZaluZec et al.
`7,252,649 B2
`8/2007 Sherry
`7,261,705 B2
`8/2007 Edoga et al.
`D554,253 S
`10/2007 Kornerup
`7,275,682 B2 10/2007 Excof?er et al.
`7,276,075 B1
`10/2007 Callas et al.
`D556,153 S
`11/2007 Burnside
`7,306,579 B2 12/2007 Fujii
`7,311,702 B2 12/2007 Tallarida et al.
`7,318,816 B2
`1/2008 Bobroffet al.
`7,318,818 B2
`1/2008 Yashiro et al.
`7,322,953 B2
`1/2008 Redinger
`D562,443 S
`2/2008 Zinn et al.
`7,331,130 B2
`2/2008 Schweikert
`7,331,948 B2
`2/2008 Skarda
`7,333,013 B2
`2/2008 Berger
`D564,449 S
`3/2008 Dewberry
`7,347,838 B2
`3/2008 Kulli
`7,347,843 B2
`3/2008 Adams et al.
`7,351,233 B2
`4/2008 Parks
`7,377,915 B2
`5/2008 Rasmussen et al.
`D574,950 S
`8/2008 Zawacki et al.
`7,413,564 B2
`8/2008 Morris et al.
`D578,203 S
`10/2008 BiZup
`7,445,614 B2 11/2008 Bunodiere et al.
`D582,032 S
`12/2008 BiZup et al.
`7,465,847 B2 12/2008 Fabian
`D595,892 S
`7/2009 Smith et al.
`7,563,025 B2
`7/2009 Kay
`7,713,251 B2
`5/2010 Tallarida et al.
`7,833,281 B2 11/2010 Lehman et al.
`2001/0016717 A1
`8/2001 Haarala et al.
`2001/0051766 A1 12/2001 GaZdZinski
`2001/0053889 A1 12/2001 Marggi et al.
`
`US 8,257,325 B2
`Page 4
`
`2001/0056266 A1 12/2001 Tallarida et al.
`2002/0095205 A1
`7/2002 Edwin et al.
`2002/0138068 A1
`9/2002 Watson et al.
`2002/0173769 A1 11/2002 Gray et al.
`2003/0010929 A1
`1/2003 Priewe et al.
`2003/0028173 A1
`2/2003 Forsberg
`2003/0130627 A1
`7/2003 Smith et al.
`2003/0139812 A1
`7/2003 Garcia et al.
`2003/0181878 A1
`9/2003 Tallarida et al.
`2003/0191452 A1 10/2003 Meglin et al.
`2004/0002693 A1
`1/2004 Bright et al.
`2004/0006316 A1
`1/2004 Patton
`2004/0019356 A1
`1/2004 Fraser et al.
`2004/0020462 A1
`2/2004 Sauler et al.
`2004/0044306 A1
`3/2004 Lynch et al.
`2004/0054352 A1
`3/2004 Adams et al.
`2004/0056266 A1
`3/2004 Suh et al.
`2004/0064110 A1
`4/2004 Forsell
`2004/0073196 A1
`4/2004 Adams et al.
`2004/0093069 A1
`5/2004 Priewe et al.
`2004/0106878 A1
`6/2004 Skujins et al.
`2004/0106891 A1
`6/2004 Langan et al.
`2004/0157952 A1
`8/2004 Sof?ati et al.
`2004/0158207 A1
`8/2004 Hunn et al.
`2004/0167543 A1
`8/2004 MaZZocchi et al.
`2004/0176743 A1
`9/2004 Morris et al.
`2004/0199129 A1 10/2004 DiMatteo
`2004/0199220 A1 10/2004 Cantlon
`2004/0204692 A1 10/2004 Eliasen
`2004/0225254 A1 11/2004 Tanaka et al.
`2004/0254536 A1 12/2004 Conlon et al.
`2004/0254537 A1 12/2004 Conlon et al.
`2005/0049553 A1
`3/2005 Triplett et al.
`2005/0070875 A1
`3/2005 Kulessa
`2005/0075614 A1
`4/2005 Bunodiere et al.
`2005/0113806 A1
`5/2005 De Carvalho et al.
`2005/0131352 A1
`6/2005 Conlon et al.
`2005/0148866 A1
`7/2005 Gunderson
`2005/0148956 A1
`7/2005 Conlon et al.
`2005/0148957 A1
`7/2005 Girard et al.
`2005/0152841 A1
`7/2005 Sayre et al.
`2005/0171502 A1
`8/2005 Daly et al.
`2005/0182857 A1
`8/2005 Kong
`2005/0209573 A1
`9/2005 Brugger et al.
`2005/0215874 A1
`9/2005 Wang et al.
`2005/0215876 A1
`9/2005 Chen et al.
`2005/0241203 A1 11/2005 LiZotte et al.
`2005/0256451 A1 11/2005 Adams et al.
`2005/0256500 A1 11/2005 Fujii
`2005/0277899 A1 12/2005 Conlon et al.
`2005/0283119 A1 12/2005 Uth et al.
`2006/0009788 A1
`1/2006 Freeman et al.
`2006/0017341 A1
`1/2006 Hahn et al.
`2006/0084929 A1
`4/2006 Eliasen
`2006/0089619 A1
`4/2006 Ginggen
`2006/0100592 A1
`5/2006 Eliasen
`2006/0116648 A1
`6/2006 Hamatake
`2006/0173410 A1
`8/2006 Moberg et al.
`2006/0173424 A1
`8/2006 Conlon
`2006/0178647 A1* 8/2006 Stats ...................... .. 604/288.01
`2006/0184141 A1
`8/2006 Smith et al.
`2006/0184142 A1
`8/2006 Schon et al.
`2006/0217359 A1
`9/2006 Wentworth et al.
`2006/0217659 A1
`9/2006 Patton
`2006/0224128 A1 10/2006 Lurvey et al.
`2006/0224129 A1* 10/2006 Beasley et al. ......... .. 604/288.01
`2006/0247584 A1 11/2006 SheetZ et al.
`2006/0253076 A1 11/2006 Butts et al.
`2006/0264898 A1* 11/2006 Beasley et al. .............. .. 604/506
`2007/0007839 A1
`1/2007 Lin
`2007/0049876 A1
`3/2007 Patton
`2007/0055290 A1
`3/2007 Lober
`2007/0073250 A1
`3/2007 Schneiter
`2007/0078391 A1
`4/2007 Wortley et al.
`2007/0078416 A1
`4/2007 Eliasen
`2007/0078432 A1
`4/2007 Halseth et al.
`2007/0083156 A1
`4/2007 Muto et al.
`2007/0149920 A1
`6/2007 Michels et al.
`2007/0149921 A1
`6/2007 Michels et al.
`
`Bard Exhibit 1001 Page 4 of 17
`
`
`
`A1
`A1
`A1
`A1
`
`2007/0161958
`2007/0161985
`2007/0179456
`2007/0185462
`2007/0191773
`2007/0208313
`2007/0219510
`2007/0233017
`2007/0233018
`2007/0255234
`2007/0270691
`2007/0270770
`2007/0276344
`2007/0299408
`2008/ 0004642
`2008/0008654
`2008/0015701
`2008/0039820
`2008/0048855
`2008/0108949
`2008/0114308
`2008/0138387
`2008/0140025
`2008/0208236
`2008/0281279
`2008/0319398
`2008/0319399
`2008/0319405
`2009/0024024
`2009/0024098
`2009/0035582
`2009/0118683
`2009/0156928
`2009/0171436
`2009/0204072
`2009/0204074
`2009/0221976
`2009/0227862
`2009/0227951
`2010/0004735
`2010/0042073
`2010/0069743
`
`7/2007
`7/2007
`8/2007
`8/2007
`8/2007
`9/2007
`9/2007
`10/2007
`10/2007
`11/2007
`11/2007
`11/2007
`11/2007
`12/2007
`1/2008
`1/2008
`1/2008
`2/2008
`2/2008
`5/2008
`5/2008
`6/2008
`6/2008
`8/2008
`11/2008
`12/2008
`12/2008
`12/2008
`1/2009
`1/2009
`2/2009
`5/2009
`6/2009
`7/2009
`8/2009
`8/2009
`9/2009
`9/2009
`9/2009
`1/2010
`2/2010
`3/2010
`
`Glenn
`Demakas et al.
`Glenn
`Byrum
`Woj cik
`Conlon et al.
`Zinn et al.
`Zinn et al.
`BiZup et al.
`Haase et al.
`Bailey et al.
`BiZup
`BiZup et al.
`Alferness et al.
`Birk et al.
`Clarke et al.
`Garcia et al.
`Sommers et al.
`Berger
`Beasley et al.
`di Palma et al.
`Machiraju
`SheetZ et al.
`Hobbs et al.
`Hoendervoogt et al.
`BiZup
`Schweikert et al.
`BiZup
`Zinn
`BiZup et al.
`Nakatani et al.
`Hanson et al.
`Evans et al.
`Casanova et al.
`Amin et al.
`Powers et al.
`Linden
`Smith et al.
`Powers et al.
`Yang et al.
`Oster et al.
`SheetZ et al.
`
`FOREIGN PATENT DOCUMENTS
`7/1986
`34 47 202
`A1
`4/1999
`197 45 654
`A1
`10/1994
`0619101
`A1
`8/2000
`0 750 520
`B1
`3/1986
`2 569 987
`A1
`3/1987
`2 586 569
`A1
`10/1988
`2 203 342
`A
`6/1996
`2500388
`Y2
`7/1996
`08-168322
`A
`4/1997
`2602109
`B2
`4/2003
`2003-102831
`A
`12/2004
`2004-350937
`A
`2/2006
`2006-025948
`1/1986
`WO 8600213
`4/1993
`WO 9305730
`95/14504
`6/1995
`1/1997
`WO 9701370
`97/06845
`2/1997
`97/11726
`4/1997
`4/1998
`WO 98/17337
`8/1999
`WO 9942166
`6/2000
`WO 0033901
`00/47264
`8/2000
`6/2002
`WO 0247549
`02/100480
`12/2002
`03/037215
`5/2003
`03/086508
`10/2003
`1/2004
`WO 2004004800
`8/2004
`WO 2004/071555
`4/2005
`WO 2005/037055
`10/2005
`WO 2004/091434
`7/2006
`WO 2006/078915
`9/2006
`WO 2006096686
`11/2006
`WO 2006116438
`12/2006
`WO 2006/130133
`
`A1
`A1
`A1
`A1
`A1
`A1
`A1
`A1
`A1
`A1
`A1
`A2
`A2
`A1
`A2
`A2
`A2
`A2
`A2
`A1
`A2
`A1
`
`US 8,257,325 B2
`Page 5
`
`12/2006
`W0 WO 2006/134100 A1
`7/2007
`W0 WO 2007079024 A2
`8/2007
`W0 WO 2007/092210 A1
`8/2007
`W0 WO 2007/094898 A2
`9/2007
`W0 WO 2007/098771 A2
`9/2007
`W0 WO 2007/109164 A2
`W0 WO 2007136538 A2 11/2007
`W0 WO 2008008126 A2
`1/2008
`W0 WO 2008019236 A1
`2/2008
`W0 WO 2008048361 A1
`4/2008
`W0 WO 2008063226 A2
`5/2008
`W0 WO 2007/126645 A2 11/2008
`W0 WO 2008/147760 A1
`12/2008
`W0 WO 2009/002839 A1
`12/2008
`W0 WO 2008157763 A1
`12/2008
`W0 WO 2009012385 A1
`1/2009
`W0 WO 2009012395 A1
`1/2009
`W0 WO 2009035582 A1
`3/2009
`W0 WO 2009/046725 A1
`4/2009
`W0 WO 2009046439 A2
`4/2009
`W0 WO 2009/108669 A1
`9/2009
`
`OTHER PUBLICATIONS
`
`BioEnterics® LAP-BAND® “Adjustable Gastric Banding System”
`by Inamed Health, Product Brochure, Dec. 2003, 22 pages.
`Cardiovascular and Interventional Radiology, Review Article, “Cen
`tral Venous Access Catheters: Radiological Management of Compli
`cations,” by U.K. Teichgraber et al., published online Jul. 31, 2003,
`13 pages.
`European Patent Of?ce Communication, dated Dec. 15, 2005, for
`Application No. 99 964 0865-1257, Applicant STD Manufacturing,
`Inc., 9 pages.
`European Patent Of?ce Communication, dated Mar. 1, 2005, for EP
`Application No. 99 964 0865-1257, Applicant STD Manufacturing,
`Inc., 4 pages.
`European Patent Of?ce Communication, dated Mar. 30, 2005, for
`Application No. 99 964 0865-1257, Applicant STD Manufacturing,
`Inc., 3 pages.
`European Patent Of?ce Communication, dated Sep. 2, 2008, for
`Application No. 06 751 411.7-1526, Applicant C.R. Bard, Inc., 4
`pages.
`LaMaitre Vascular “Port Implantations: using the OptiLock Implant
`able Port,” product information, available at http://www.lemaitre.
`com/specsipopasp, last accessed Apr. 2003, 14 pages.
`LAP-BAND APTM “System with Adjustable Gastric Banding system
`with OMNIFORMTM Design,” Product Brochure, Jul. 2007, 16
`pages.
`LAP-BAND® “Adjustable Gastric Banding System” by BioEnterics
`Corporation, Product Brochure, 12 pages.
`Lap-Band® System Fact Sheet, © 2007 Allergan, Inc., 2 pages.
`MedComp “PortCT Technology”, display at SIR Conference,
`Toronto, Canada, (Mar. 2006), 1 page.
`Nucleus Cochlear Implant Systems; User Manual for the ESPrit 3G
`speech processor and accessories, available at http://www.
`cochlearamericas.com/PDFs/UserManualSprintpdf, Issue 2, Dec.
`2001, 2 pages.
`Oct. 22, 2009 Declaration of Kelly Christian, Director of Product
`Development at BARD Access Systems, Inc, in support of and
`depicting a product on the market by Quinton Company approXi
`mately ten years prior to Oct. 22, 2009, 1 page.
`Port-A-Cath® “Implantable Epidural, Aterial and Peritonial Access
`Systems,” Internet Product Listing of Nov. 19, 2000 archived at
`http://web.
`archive.org/web/20001119035900/www.deltec.com/
`cPacspl.htm, last accessed Oct. 17, 2009, 2 pages.
`Port-A-Cath® “Many Port-A-Cath® System Choices,” Product Bro
`chure, © 1996 SIMS Deltec, Inc., 5 pages.
`Port-A-Cath® “Single-lumen Implantable Vascular Access Sys
`tems,” Product Speci?cations, 2004 Smith Medical, 4 pages.
`Rappolt, Richard T., et al., “Radiopaque Codi?cation and X-ray
`identi?cation of Ingested Drugs,” Ingestive Radioiogy, May-Jun.
`1966, 4 pages.
`Shah, Tilak M. “Radiopaque Polymer Formulations for Medical
`Devices” Medical Device and Diagnostic Industry, Mar. 2000, 6
`pages.
`
`Bard Exhibit 1001 Page 5 of 17
`
`
`
`US 8,257,325 B2
`Page 6
`
`Urquiola, Javier, et al., “Using Lead Foil as a Radiopaque Marker for
`Computerized Tomography Imaging When Implant Treatment Plan
`ning,” The Journal ofProsthetic Dentistry, vol. 77, No. 2, Feb. 1997,
`pp. 227-228.
`PCT/US06/008022 International Search Report, mailed Jul. 5, 2006,
`2 pages.
`PCT/US06/015695 International Search Report, mailed Jan. 11,
`2007, 6 pages.
`PCT/US06/49007 International Search Report, mailed Oct. 1, 2007,
`2 pages.
`PCT/US06/49007 Written Opinion, mailed Oct. 1, 2007, 4 pages.
`PCT/US07/006776 International Search Report, mailed Dec. 18,
`2007, 1 page.
`PCT/US07/006776 Written Opinion, mailed Dec. 18, 2007, 3 pages.
`PCT/US08/067679 International Search Report, mailed Sep. 30,
`2008, 3 pages.
`PCT/US08/067679 Written Opinion, mailed Sep. 30, 2008, 4 pages.
`PCT/US08/070330 International Search Report, mailed Dec. 1,
`2008, 5 pages.
`PCT/US08/070330 Written Opinion, mailed Dec. 1, 2008, 5 pages.
`PCT/US08/070345 International Search Report, mailed Dec. 1,
`2008, 5 pages.
`PCT/US08/070345 Written Opinion, mailed Dec. 1, 2008, 6 pages.
`U.S. Appl. No. 10/374,000, AdvisoryAction, mailed Jan. 23,2007, 3
`pages.
`U.S. Appl. No. 10/374,000, Of?ce Action, mailed Aug. 28, 2007, 8
`pages.
`U.S. Appl. No. 10/374,000, Of?ce Action, mailed Feb. 13, 2006, 7
`pages.
`U.S. Appl. No. 10/374,000, Of?ce Action, mailed Feb. 28, 2007, 8
`pages.
`U.S. Appl. No. 10/374,000, Of?ce Action, mailed Jul. 28, 2006, 8
`pages.
`U.S. Appl. No. 10/374,000, Of?ce Action, mailed Mar. 20, 2008, 6
`pages.
`U.S. Appl. No. 10/374,000, Of?ce Action, mailed May 20, 2009, 9
`pages.
`U.S. Appl. No. 10/374,000, Of?ce Action, mailed Sep. 30, 2008, 7
`pages.
`U.S. Appl. No. 10/374,000, Response to Of?ce Action, ?led Dec. 28,
`2006, 9 pages.
`U.S. Appl. No. 10/374,000, Response to Of?ce Action, ?led Jun. 20,
`2008, 8 pages.
`U.S. Appl. No. 10/374,000, Response to Of?ce Action, ?led Mar. 30,
`2009, 11 pages.
`U.S. Appl. No. 10/374,000, Response to Of?ce Action, ?led May 12,
`2006, 7 pages.
`U.S. Appl. No. 10/374,000, Response to Of?ce Action, ?led May 29,
`2007,2006, 11 pages.
`US. Application No. 10/374,000, Response to Of?ce Action, ?led
`Oct. 31, 2007, 8 pages.
`US. Application No. 10/374,000, Response to Of?ce Action, ?led
`Sepember 21, 2009, 13 pages.
`U.S. Appl. No. 11/320,223, Of?ce Action, mailed Feb. 13, 2008, 11
`pages.
`U.S. Appl. No. 11/320,223, Of?ce Action, mailed Sep. 18, 2008, 7
`pages.
`U.S. Appl. No. 11/368,954, Preliminary Amendment, ?led Dec. 19,
`2007, 9 pages.
`U.S. Appl. No. 11/380,124, Of?ce Action, mailed Jan. 16,2009, 10
`pages.
`U.S. Appl. No. 11/725,287, Of?ce Action, mailed Jun. 12, 2009, 5
`pages.
`U.S. Appl. No. 11/725,287, Of?ce Action, mailed Dec. 3, 2008, 7
`pages.
`U.S. Appl. No. 12/175,182, Of?ce Action, mailed Sep. 3, 2009, 7
`pages.
`U.S. Appl. No. 29/284,454, ?led Sep. 7, 2007, entitled “Implantable
`Port Device,” issued Aug. 12, 2008 as US. Patent No. D574,950, 8
`pages.
`U.S. Appl. No. 29/284,456, ?led Sep. 7, 2007 entitled “Implantable
`Port Device,” 8 pages.
`
`U.S. Appl. No. 60/658,518, ?led Mar. 4, 2005, publicly accessible
`Oct. 5, 2006, 62 pages.
`“Extravasation of Radiologic Contrast.” PA-PSRS Patient Safety
`Advisoryivol. 1, No. 3, Sep. 2004, 6 pages.
`Bif?, R. et al. “Best Choice of Central Venous Insertion Site for the
`Prevention of Catheter-Related Complications in Adult Patients Who
`Need Cancer Therapy: A Randomized Trial” Annals of Oncology,
`Jan. 29, 2009, 6 pages
`Bif?, R. et al. “Use of totally implantable central venous access ports
`for high-dose chemotherapy and peripheral blood stem cell trans
`plantation: results of a monocentre series of 376 patients” Annals of
`Oncology 15:296-300, 2004, 5 pages.
`Bif?, Roberto, et al. “A Randomized, Prospective Trial of Central
`Venous Ports Connected to Standard Open-Ended or Groshong Cath
`eters in Adult Oncology Patients” American Cancer Society, vol. 92,
`No. 5, pp. 1204-1212, Sep. 1, 2011, 9 pages.
`Costa, Nancy, “More Than Skin Deep: An Overview of Iodinated
`Contrast Media” Journal for the Association for Vascular Access,
`vol. 8, No. 4, 2003, 6 pages.
`Costa, Nancy, “Understanding Contrast Media” Journal of Infusion
`Nursing, vol. 27, No. 5, Sep./Oct. 2004, 11 pages.
`Extreme Access, Bard Access Systems, Inc., Product Brochure,
`2003, 5 pages.
`Fallscheer, et al., “Injury to the Upper Extremity Caused by
`Extravasation of Contrast Medium: A True Emergency” Scandina
`vian Journal of Plastic and Reconstructive Surgery and Hand Sur
`gery, vol. 41, pp. 26-32, 2007, 7 pages.
`Hou, Shaw-Min et al. “Comparisons of Outcomes and Survivals for
`Two Central Venous Access Port Systems” Journal of Surgical
`Oncology, 91:61-66, 2005, 6 pages.
`Johnson, Kathleen A., “Power Inj ectable Portal Systems,” Journal of
`Radiology Nursing, vol. 28, Issue 1, Mar. 2009, 6 pages.
`LAP-BAND System Access Port Fill Guide I, “9.75/10.0 cm Lap
`Band System vs. 1 1 cm LAP-BAND System: For Product Manufac
`tured Prior to Jul. 2001” BioEnterics Corporation, 1 page.
`Port-A-Cath PA.S. PORT Systems by Deltec, Product Speci?ca
`tions, 1999, 2 pages.
`Sandstede, Joern, “Pediatric CT,” available online at www.
`multislice-ct.com, MultiSLICE-CT.com, version 02, May 2, 2003,
`36 pages.
`Sanelli, et al., “Safety and Feasibility of Using a Central Venous
`Catheter for Rapid Contrast Injection Rates.” American Journal of
`Radiology, vol. 183, pp. 1829-1834, Dec. 2004, 6 pages.
`Smith, Lisa Hartkoph, “Implanted Ports, Computer Tomography,
`Power Injectors, and Catheter Rupture” Clinical Journal of Oncol
`ogy Nursing, vol. 12, No. 5 Oct. 2008, 4 pages.
`Solomon, et al., “CIN Strategies: Anticipate, Manage, Prevent”
`Supplement to Imaging Economics, May 2007, 20 pages.
`Steinbach, Barbara, G., Hardt, N. Sisson, Abbitt, Patricia L., Lanier,
`Linda, Caffee, H. Hollis, “Breast Implants, Common Complications,
`and Concurrent Breast Disease.” RadioGraphics, vol. 13, No. 1, pp.
`95-118, 1993, 24 pages.
`Sullivan et al. “Radiopaque Markers on Mammary Implants” Ameri
`can Journal of Roentgenology 153(2):428, Aug. 1989, 2 pages.
`US. Food and Drug Administration, “Guidance for Institutional
`Review Boards and Clinical Investigators 1998 Update: Medical
`Devices” Version Sep. 10, 2008, 13 pages.
`Vergara, et al., “Adverse Reactions to Contrast Media in CT: Effects
`of Temperature and Ionic Property” Radiology, vol. 199, No. 2, May
`1996, 4 pages.
`Vogelzang, Robert L., “Power Injection Through Central Venous
`Catheters: Physiological and Hemodynamic Considerations” The
`McGaw Medical Center of Northwestern University, Feinberg
`School of Medicine, 3 pages.
`Wells, S. “Venous Access in Oncology and Haematology Patients:
`Part One”Nursing Standard, vol. 22, No. 52, pp. 39-46, Sep. 3, 2008,
`9 pages.
`Williamson, et al., “Assessing the Adequacy of Peripherally Inserted
`Central Catheters for Power Injection of Intravenous Contrast Agents
`for CT” Journal of Computer Assisted Tomography, vol. 6, No. 6, pp.
`932-937, 2001, 6 pages.
`International Application No. PCT/US1999/028695, International
`Preliminary Examination Report, dated Apr. 21, 2001, 4 pages.
`
`Bard Exhibit 1001 Page 6 of 17
`
`
`
`US 8,257,325 B2
`Page 7
`
`International Application No. PCT/US1999/028695, International
`Search Report, dated Apr. 11, 2000, 2 pages.
`International Application No. PCT/US2006/008022, International
`Preliminary Report on Patentability and Written Opinion, dated Sep.
`12, 2007, 6 pages.
`International Application No. PCT/US2006/015695, International
`Preliminary Report on Patentability and Written Opinion, dated Oct.
`30, 2007, 9 pages.
`International Application No. PCT/US2006/016056, International
`Preliminary Report on Patentability and Written Opinion, dated Oct.
`30, 2007, 9 pages.
`International Application No. PCT/US2006/016056, International
`Search Report, dated Sep. 20, 2006, 4 pages.
`International Application No. PCT/US2006/049007, Internation